WO2010092893A1 - Surgical operation system for lumbar interbody fusion and device for keeping lumbar interbody space to be used in surgical operation for lumbar interbody fusion - Google Patents

Surgical operation system for lumbar interbody fusion and device for keeping lumbar interbody space to be used in surgical operation for lumbar interbody fusion Download PDF

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Publication number
WO2010092893A1
WO2010092893A1 PCT/JP2010/051558 JP2010051558W WO2010092893A1 WO 2010092893 A1 WO2010092893 A1 WO 2010092893A1 JP 2010051558 W JP2010051558 W JP 2010051558W WO 2010092893 A1 WO2010092893 A1 WO 2010092893A1
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WIPO (PCT)
Prior art keywords
interbody fusion
main body
rear end
vertebral bodies
interbody
Prior art date
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PCT/JP2010/051558
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French (fr)
Japanese (ja)
Inventor
哲雄 佐藤
孝 五十嵐
憲正 瀬尾
Original Assignee
学校法人自治医科大学
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Priority to JP2010550492A priority Critical patent/JP5553268B2/en
Publication of WO2010092893A1 publication Critical patent/WO2010092893A1/en

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    • AHUMAN NECESSITIES
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    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/446Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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Definitions

  • the present invention relates to an interbody fusion surgery in which an interbody fusion device is inserted into an intervertebral disc space modified at an appropriate interval between two adjacent vertebral bodies (vertebrae) to fix the vertebral bodies.
  • An interbody fusion surgery in which an interbody fusion device is inserted into an intervertebral disc space modified at an appropriate interval between two adjacent vertebral bodies (vertebrae) to fix the vertebral bodies.
  • plates or rods are filled with bone material as a support between the vertebral bodies to facilitate the fixation of the two adjacent vertebral bodies and stably connect and fix the damaged vertebral bodies Is used.
  • a fixing member such as a plate or a rod fixed to the vertebral body to maintain the stability of the vertebral body is no longer an obstacle.
  • the surgical procedure for implanting and fixing these rods or plates is performed from behind the spinal column by general anesthesia, and the muscles and nerves that extend along the spinal column are complicatedly complicated behind the spinal column, and these muscles can be peeled off. This is a major operation that takes a long time because it is troublesome to prevent the nerve from being damaged, and the surgical invasion is excessive.
  • FIG. 48 is a perspective view of the conventional interbody fusion device of the first example
  • FIG. 49 is a longitudinal sectional view (main part cross section) of the conventional interbody fusion device of the second example fixed between the vertebral bodies. It is.
  • the interbody fusion device 100 of the first example has male threads 118 and 119 formed on the outer surface of a tapered hollow frustoconical shape with the front end 113 opened or closed and the rear end 112 opened, It consists of a main body 111 formed with parallel truncated side walls 122 and is screwed in between adjacent vertebral bodies (not shown) via male screws 118 and 119. (See Patent Document 1).
  • male threads 258 and 259 are formed on the outer surface of a tapered hollow frustoconical shape in which the front end 253 is open or closed and the rear end 256 is partially open.
  • a pair of screw holes 267 and 267 provided so as to incline in a divergent shape toward the upper and lower vertebral bodies L4 and L5 adjacent to the rear end 256, respectively.
  • the interbody fusion devices of the first example and the second example are both of a small size that can be inserted between the upper and lower vertebral bodies to which the main bodies 111 and 251 are adjacent, particularly the conventional rod. Or it can be transplanted and fixed between vertebral bodies in a relatively short time using a laparoscope from the abdominal side compared with the large-scale surgical operation from the back side of transplanting and fixing plates, etc. Can be expected to significantly reduce.
  • a vertebra for maintaining an intervertebral disc space by correcting an appropriate interval between two adjacent vertebral bodies (vertebrae) required in advance when implanting and fixing these interbody fusion devices between vertebral bodies.
  • vertebrae a vertebra for maintaining an intervertebral disc space by correcting an appropriate interval between two adjacent vertebral bodies (vertebrae) required in advance when implanting and fixing these interbody fusion devices between vertebral bodies.
  • interbody space holding device There is a typical example of the recently proposed interbody space holding device.
  • FIG. 50 is a perspective view of a conventional typical interbody space holding device (ventral ventral lordosis extending external sleeve), and FIG. 51 is a side view of the interbody space holding device of FIG. 50 inserted between the vertebral bodies.
  • FIG. 50 is a perspective view of a conventional typical interbody space holding device (ventral ventral lordosis extending external sleeve)
  • FIG. 51 is a side view of the interbody space holding device of FIG. 50 inserted between the vertebral bodies.
  • a conventional typical interbody space holding device (ventral anterior lordosis extending outer sleeve) 300 is a long hollow tubular member provided with a cylindrical outer end 330 at the rear end.
  • 302 is connected to the distal end 310 of 302, and a plurality of teeth 312 respectively engaged with front surfaces of adjacent vertebral bodies L6 and L7, and a height that restores the height of the disc space between the vertebral bodies L6 and L7.
  • a pair of extension portions 320 and 322 are provided so as to face each other and extend at a 180-degree relationship. (See FIGS. 31 and 32 of Patent Document 3).
  • JP 2007-75632 A (priority claim number: US08 / 603, 674)
  • JP-T-2002-501784 (priority claim number: US09 / 014,901)
  • JP 2004-267786 A (priority claim number: US08 / 396,414)
  • the interbody fusion device described in Patent Document 1 (first example) is configured such that the main body 111 is simply screwed between the adjacent upper and lower vertebral bodies via male screws 118 and 119. After insertion between vertebral bodies, there is a problem that the proper spacing between the vertebral bodies tends to be lost by retreating or rotating from an appropriate position between the vertebral bodies.
  • the main body 251 is screwed between the adjacent vertebral bodies L4 and L5 via the male screws 258 and 259, and then the main body 251. Since the pair of bone screws 280 and 280 inserted through the rear end 256 is obliquely screwed into the vertebral bodies L4 and L5, the appropriateness between the vertebral bodies of the main body 251 as in Patent Document 1 is described. It has been improved to prevent retraction and rotation from position.
  • a pair of screw holes 267, 267, a bone screw 280, 280, and a pair of bone screws 280, 280 which are provided so as to incline toward the upper and lower vertebral bodies L4, L5 adjacent to the rear end 256, respectively.
  • the structure of the setscrew 282 for retaining the screw and the processing thereof are complicated, and further, a so-called triaxial screwing operation of the main body 251 and the setscrew 282 and a pair of bone screws 280, 280 intersecting with these main shafts.
  • the interbody space holding device (ventricular lordosis extension external sleeve) 300 described in Patent Document 3 is a cannula in the abdominal part for endoscope formed from the human abdomen to the front surface of the adjacent vertebral bodies L6 and L7.
  • the height of the disc space is restored and a plurality of teeth 312 is restored via a pair of extensions 320 and 322 provided at the distal end 310 of the hollow tubular member 302, respectively.
  • the interbody fusion device is relatively fixed when transplanting and fixing the vertebral bodies L6 and L7.
  • the vertebral bodies L6 and L7 to which a large external force is applied have a drawback in that the engagement with the plurality of teeth 312 is disengaged and the vertebral bodies L6 and L7 are liable to shift backward or left and right.
  • the present invention has been made in view of the above-mentioned problems of the prior art, and an object of the present invention is to simplify and reduce the overall structure with a simple configuration, and to improve operability, reliability and Necessary for interbody fusion surgery system with an interbody fusion device that is highly economical and easily reduces the burden on the patient and surgical invasion by performing the interbody fusion treatment easily in a short time. It is an object of the present invention to provide an interbody space holding device for interbody fusion surgery with improved reliability.
  • the interbody fusion surgical system is a generally hollow body with a front end that is formed so as to maintain an appropriate distance between two adjacent vertebral bodies (vertebrae).
  • An outer surface engaging portion that engages with the opposing surface portions of the two vertebral bodies is formed on the outer surface of the cylindrical or tapered hollow truncated cone, and a female screw of an appropriate depth is formed on the hollow inner surface on the rear end side.
  • a main body in which one or a plurality of bent or straight guide holes are formed so as to incline in the radial direction from the hollow inner surface of the distal end toward the opposing surface of the vertebral body and penetrate to the outer surface;
  • One or a plurality of bent or straight pins inserted into the guide holes along the guide holes and screwed into the female screw of the main body, and the axial propulsive force of the rear ends of the pins.
  • a pressing screw for pressing the end After the main body is inserted and fixed in the intervertebral disc space via the outer surface engaging portion, the rear end is pressed by the axial thrust of the pressing screw screwed into the female screw of the main body.
  • an intervertebral body fixing device in which the distal end side is sequentially guided along the guide hole and inserted into the vertebral body.
  • the invention according to claim 2 is the interbody fusion surgical system according to claim 1, characterized in that the outer diameter of the central part of the substantially hollow cylindrical body is formed in a slightly thick drum shape. To do.
  • a third aspect of the present invention is the interbody fusion surgical system according to the first aspect, wherein the pin is a solid or hollow rod-shaped body having an arbitrary cross-sectional shape including a circle or a polygon, or at least the distal end side or the entire length. It consists of a rod-shaped laminated body with an arbitrary cross-sectional shape including a round or polygonal shape laminated with a plurality of thin plate materials or a wire having an arbitrary cross-sectional shape including circles and various flat shapes, and the tip thereof is sharp It is formed.
  • the invention according to claim 4 is the interbody fusion surgical system according to any one of claims 1 to 3, wherein the one or more pins are provided with a female screw hole at a rear end. Proximal end portions are individually or integrally formed and continuously provided, and the pressing screw is rotated from within the main body by a rotation operation in a direction opposite to the screwing direction into the main body, and the main body is moved between the vertebral bodies. Can be removed from between the vertebral bodies by being rotated in the direction opposite to the insertion direction and / or withdrawing operation, and removed from the body.
  • the pin After the pin is inserted into the vertebral body, The pin is pulled out from the main body, and the pin is pulled out from between the vertebral bodies by a pull-out driver having a male threaded portion that engages with a female threaded hole at the base end, and is taken out of the body together with the main body. It is characterized by being.
  • a fifth aspect of the present invention is the interbody fusion surgical system according to the fourth aspect, wherein a blind plug having an engaged portion at the rear end is normally inserted into the female screw hole of the pin base end. Prior to the pulling-out operation of the pin, the blind plug can be removed from the female screw hole and taken out of the body by a screwdriver having an engaging portion that engages the engaged portion at the tip. It is characterized by that.
  • a sixth aspect of the invention is the interbody fusion surgical system according to the first aspect, wherein the outer surface engaging portion is formed in a male screw shape.
  • the invention according to claim 7 is the interbody fusion surgical system according to claim 1, wherein the outer surface engaging portion is formed in a plurality of spline teeth parallel to the main axis. .
  • the invention according to claim 8 is the interbody fusion surgical system according to claim 1, wherein the outer surface engaging portion is formed in a plurality of sawtooth shapes parallel to the main axis.
  • the invention according to claim 9 is the interbody fusion surgical system according to any one of claims 1, 6 to 8, wherein the distal end in the axial direction and the outer radial head of the outer surface engaging portion are provided.
  • the top is formed in the shape of a sharp blade.
  • a tenth aspect of the invention is the interbody fusion surgical system according to any one of the first to ninth aspects, wherein the main body has an angiogenesis opening communicating with the upper, lower, left, and right sides of the outer surface. And a plurality of openings for bone ingrowth.
  • the invention of claim 11 is the interbody fusion surgical system according to any one of claims 1 to 10, wherein the whole or part of the rear end surface of the main body is attached to the rear end of the pressing screw. A covering cap is formed.
  • the invention according to claim 12 is the interbody fusion surgical system according to claim 11, wherein the boss is loosely fitted to the pressing screw, and is erected on the outer surface of the boss so as to be axially symmetrical. It further comprises a fixing reinforcing tool comprising a pair of arms whose rear end surface is pressed against the cap portion and whose front end portion is engaged and fixed to the abdomen front surface of the adjacent vertebral body.
  • a thirteenth aspect of the invention is the interbody fusion surgical system according to any one of the first to twelfth aspects, wherein the interbody fusion surgical system is loosely accommodated in the female screw of the main body, and is attached to the rear end portion of the pin. It is further characterized by further including a friction plate disposed in contact therewith.
  • the invention according to claim 14 is the interbody fusion surgical system according to claim 13, wherein the rear end portion of the pin is engaged with the friction plate so as to be restrained from moving at least in the left-right direction. It is fixed.
  • the invention of claim 15 is the interbody fusion surgery system according to any one of claims 1 to 14, wherein the interbody fusion device is a vertebral body using a laparoscope in combination from the abdominal side. It is fixed between the vertebral bodies by interstitial surgery.
  • a sixteenth aspect of the present invention is the interbody fusion surgical system according to any one of the first to fifteenth aspects, wherein the distal end of a hollow long shaft portion having a grip portion at the rear end is provided.
  • a front end engaging portion that engages with a rear end engaging portion formed at a rear end portion of the main body of the interbody fusion device, and the front end engaging portion is engaged with the rear end engaging portion of the main body;
  • the interbody space holding device is inserted into a cannula in the abdominal cavity for endoscope formed from the living body abdomen to the front surface of the vertebral body to maintain an appropriate distance between the two adjacent vertebral bodies.
  • a main body insertion driver for inserting the main body between the vertebral bodies by pressing or / and rotating the main body.
  • the invention according to claim 17 is the interbody fusion surgery system according to claim 16, wherein the main body insertion driver has a tip engaging portion made of metal and a shaft portion made of a polymer material. To do.
  • the invention of claim 18 is the interbody fusion surgery system according to claim 16 or claim 17, wherein the interbody fusion device is attached to the distal end of a long shaft portion provided with a grip portion at the rear end.
  • a front end engaging portion that engages with a rear end engaging portion formed at a rear end portion of the pressing screw, and the front end engaging portion is engaged with the rear end engaging portion of the pressing screw in the state where the front end engaging portion is engaged.
  • the invention according to claim 19 is the interbody fusion surgical system according to claim 18, wherein the pressing screw driver has a tip engaging portion made of metal and a shaft portion made of a polymer material. To do.
  • the interbody space holding device for interbody fusion surgery corrects an appropriate interval between two adjacent vertebral bodies (vertebrae) during a body interbody fusion surgery.
  • a device for holding the intervertebral disc space having a gripping portion at the rear end and being inserted to the vicinity of the front surface of the vertebral body via a cannula in the abdominal portion for endoscope provided on the living body abdominal portion side
  • a hollow long first shaft portion and a fixing claw extending in the axial direction at the distal end portion of the first shaft portion and holding and fixing the left and right side surfaces of the adjacent vertebral bodies at the distal end
  • a vertebral body clamping mechanism having at least one pair of clamp arms connected to each other and capable of opening and closing in an orthogonal plane of the vertebral body.
  • the invention of claim 21 is the interbody space holding device for interbody fusion surgery according to claim 20, wherein the vertebral body clamp mechanism has each of the fixing claws connected to the tip, and the rear end Each having an elastic support portion that is elastically supported by being bent so as to open and expand the fixed claw in the orthogonal plane of the vertebral body in a free state.
  • a pair of clamp arms and a front end portion of a hollow long second shaft portion which is externally fitted to the first shaft portion so as to be movable forward / backward, and provided with a gripping portion at the rear end are advanced to the elasticity. Clamps that open the pair of clamp arms in the diameter increasing direction by closing the pair of clamp arms in the diameter reducing direction by pressing the support parts from the outside and retreating the tip parts from the elastic support parts.
  • An arm opening and closing tube is provided.
  • the invention of claim 22 is the interbody space holding device for interbody fusion surgery according to claim 20, wherein the vertebral body clamping mechanism has the respective fixing claws connected to the tip, and the rear end portion.
  • a pair of clamp arms pivotally attached to the distal end portion of the first shaft portion via a first support shaft in an orthogonal plane of the vertebral body, and the first shaft portion
  • a hollow long second shaft portion that is externally fitted so as to be able to move forward / backward and a grip portion is provided at the rear end, and an intermediate portion of each of the pair of clamp arms via a second support shaft.
  • Each pair of link members is pivotably attached to each other, and each other end thereof is pivotally attached to the tip of the second shaft portion via a third support shaft.
  • each of the pair of link members is moved in the first shaft by the second shaft portion moving forward or backward.
  • the pair of clamp arms are closed or expanded in the diameter-reducing direction with the first support shaft as a fulcrum within the orthogonal plane of the vertebral body by swinging counterclockwise or clockwise around the support shaft as a fulcrum.
  • a toggle mechanism that opens in a direction is configured.
  • the invention of claim 23 is the interbody space holding device for interbody fusion surgery according to any one of claims 20 to 22, wherein the vertebral body is provided on the vertebral body clamping surface of the fixation claw. It has a plurality of sharp protrusions that can be pierced on the side surface.
  • the interbody space holding device for interbody fusion surgery corrects an appropriate distance between two adjacent vertebral bodies (vertebrae) during a body interbody fusion surgery.
  • a device for holding the intervertebral disc space having a gripping portion at the rear end and being inserted to the vicinity of the front surface of the vertebral body via a cannula in the abdominal portion for endoscope provided on the living body abdominal portion side
  • a hollow elongate first shaft portion and a threaded portion that extends in the axial direction on the outer surface of the first shaft portion so as to be rotatable in the axial direction, are formed on one or both of the adjacent vertebral bodies.
  • a long fixing screw member that is inserted into and fixed to the front surface portion, and one or a plurality that can project into the front surface portion of one or both of the adjacent vertebral bodies protruding from the distal end portion of the first shaft portion A needle-like protrusion.
  • a twenty-fifth aspect of the invention is the interbody space holding device for interbody fusion surgery according to any one of the twenty-second to twenty-fourth aspects, wherein the vertebra is provided at a distal end portion of the first shaft portion.
  • the adjacent vertebral bodies are properly connected to each other by extending into the intervertebral space at an interval slightly narrower than the outer diameter of the body and facing the intervertebral space in the axial direction. It is further characterized by further comprising at least one pair of spacers formed in an outer shape so as to be corrected and held at intervals.
  • the interbody fusion device is a small size having an outer shape adapted to an appropriate distance between adjacent vertebral bodies, and after the main body is inserted and fixed between the vertebral bodies, the pressing screw is attached to the main body. Since the tip side of the pin that is pressed just by screwing into the female screw is guided along the guide hole and is inserted into the vertebral body and fixed, all from the main axis direction using the laparoscope The interbody fusion treatment can be easily performed in a short time by only pressing or / and screwing by one axis.
  • the operation scale can be greatly reduced as compared to conventional interbody fusion surgery, and the operation time and recovery period can be greatly reduced, so that the physical and mental burden of medical staff including patients and doctors, The surgical invasion and even the economic burden on the patient can be significantly reduced.
  • the pin inserted and fixed in the vertebral body can prevent the intervertebral body fixing device body from retreating or rotating from the appropriate position between the vertebral bodies.
  • the vertebral body is secured, and the interbody fixing structure and the operation of only pressing or / and screwing by one axis in the main body axis direction are greatly simplified and compacted as described above, and the operability and economy are further excellent. It is possible to provide an interbody fusion surgical system having an interbody fusion device, and so on.
  • the outer diameter of the central part of the substantially hollow cylindrical main body is formed in a slightly thick drum shape. There is an effect that is firmly fixed between the bodies.
  • the pin in addition to having the same effect as that of the invention of claim 1, since the tip of the pin is formed sharply, the pin can be easily inserted into the vertebral body. Further, a pin made of a hollow rod-like body or a rod-like laminated body is relatively easy to bend and deform, and the tip side is smoothly guided along the guide hole of the main body. Such a pin can be easily formed into an arbitrary shape, and the design flexibility is improved.
  • the interbody fusion device is fixed between the vertebral bodies via the pins.
  • the pin is pulled out from between the vertebral bodies by a pulling screwdriver that is screwed into the female screw hole at the proximal end, and is taken out of the body together with the main body.
  • the interbody fusion device can be re-fixed between the vertebral bodies again after a treatment such as filling with an antibiotic or an aggregate if necessary.
  • the intervertebral body is inserted into the female screw hole by the blind plug that is removably inserted into the female screw hole of the pin base end portion.
  • the blind plug removes the blind plug from the female screw hole before pulling out the pin, and make it easy to quickly and easily screw the extraction screwdriver into the female screw hole at the base end of the pin. Therefore, the operability of removing the interbody fusion device can be improved.
  • the outer surface engaging portion is formed in a male screw shape, the main body can be easily screwed and fixed between the vertebral bodies. There is an effect that can.
  • the outer surface engaging portion is formed in a plurality of spline teeth parallel to the main shaft, so that the main body is pressed. It is possible to insert and fix between vertebral bodies in a short time just by doing so, and there is an effect of improving operability.
  • the outer surface engaging portion is formed in a plurality of sawtooth shapes parallel to the main shaft, so that the main body is pressed. It has the effect of being able to easily fit between vertebral bodies in a short time and to secure the fixing reliability by retaining.
  • a plurality of angiogenesis openings and bones are provided on the upper, lower, left and right sides of the outer surface of the main body. Due to the presence of ingrowth openings, these openings contact the highly vascularized tissue surrounding the vertebral body to provide a path for promoting angiogenesis and adjacent vertebral body facing surfaces
  • the bleeding from the vertebrae serves as a passage for facilitating bone internal tissue growth and has an effect of promoting interbody fusion.
  • the interbody fixing device itself becomes a kind of fixed body of the bone mass.
  • the cap formed at the rear end of the pressing screw is provided at the rear end of the main body.
  • the cap By covering the entire surface or a part thereof, there is an effect of preventing the outflow of the bone-forming material or the like that contains the bone morphogenic protein that promotes fixation in the liquid carrier and is filled in the hollow body.
  • the screw screw since the cap finally comes into contact with the rear end surface of the main body or the front surface of the vertebral body, the screw screw is allowed to be screwed into the main body, and the reverse rotational frictional force of the press screw is increased. This also has the effect of preventing the reverse rotation of the pin and preventing the pin from coming off.
  • a pair of arm tip portions of the fixing reinforcement loosely fitted to the press screw are bosses on the cap portion of the press screw.
  • the pin rear end pressing of the pressing screw is performed via the friction plate. Therefore, the frictional force between the pressing screw and the pin rear end surface is reduced and the pin rear end surface is not directly subjected to the rotational force of the pressing screw. There is an effect that the pressing screw can be screwed with a small torque and the pin can be smoothly pushed forward without almost receiving the force to be sent.
  • the rear end portion of the pin is engaged or fixed to the friction plate so that the movement in the left-right direction is restricted at least. Therefore, the push screw is screwed into the female screw with a small torque and the pin is not subjected to almost any force that tends to be pushed in the left-right direction with a large gap with the inner surface of the female screw part. There is an effect of improving reliability that can be pushed in smoothly.
  • the interbody fusion device is a vertebra using a laparoscope in combination from the abdomen side. Because it is fixed between vertebral bodies by interbody fusion surgery, the operation scale is greatly reduced and the operation time and recovery period are also greatly reduced compared to the conventional interbody fusion surgery from the back side. Therefore, the physical and mental burden of the medical staff including the patient and the doctor, the surgical invasion of the patient, and the economic burden can be remarkably reduced.
  • the main body insertion driver has a tip engaging portion made of hard metal and the shaft portion is made of a lightweight resin or the like. Since it can be composed of a molecular material, the whole is reduced in weight and has the effect of improving operability.
  • the rear end grip portion of the press screw driver is gripped and the tip engagement portion is placed behind the press screw. Inserted into the hollow part of the main body insertion driver with the end engaged, and inserted into the female screw part of the main body of the interbody fusion device and rotated while rotating, and screwed into the female screw.
  • the pin can be inserted into the vertebral body while sequentially guiding the tip side of the pin along the guide hole by the direction propulsive force, and there is an effect of facilitating the pin insertion fixing operation by one axis in the main body main axis direction.
  • the main body insertion driver has a tip engaging portion made of a hard metal, and the shaft portion is a lightweight polymer such as a resin. Since it can be comprised from a material, the whole is reduced in weight and there exists an effect which improves operativity.
  • an interbody fusion surgical interbody space holding device that corrects an appropriate distance between two adjacent vertebral bodies to maintain an intervertebral disc space. Since the left and right side surfaces of adjacent vertebral bodies are sandwiched and fixed by the claws, the vertebral bodies to which a relatively large external force is applied when the interbody fusion device is subsequently implanted and fixed between the vertebral bodies are posterior or left and right Therefore, there is an effect that the reliability of the interbody space retention in the interbody fusion surgery is ensured.
  • each of the elastic support portions is provided by advancing or retreating the clamp arm opening / closing pipe fitted on the first shaft portion. Since a pair of clamp arms are closed in the diameter-reducing direction or opened in the diameter-enlarging direction, the structure and operation of the interbody space holding device that clamps and fixes the left and right side surfaces of adjacent vertebral bodies are simplified. There is.
  • the plurality of sharp protrusions of the fixed claw can be easily pierced on the side surface of the vertebral body.
  • an interbody fusion space holding device for interbody fusion surgery that corrects an appropriate distance between two adjacent vertebral bodies and holds an intervertebral disc space is provided on the first shaft portion. From a long fixing screw member and a needle-like projection provided on the outer surface and the distal end, respectively, one or both front surfaces of the adjacent vertebral bodies are respectively screwed and pierced to be fixed with a retaining effect.
  • the structure and operation of the interbody space holding device is simple and the vertebral body to which a relatively large external force is applied when the interbody fusion device is subsequently implanted and fixed between the vertebral bodies is located on the posterior or left and right sides. Therefore, the reliability of the interbody space retention in the interbody fusion surgery is ensured.
  • a vertebral body clamping mechanism or a long length is provided in one interbody space holding device.
  • Intervertebral body fixation because it combines a fixed screw member / needle-like process and a pair of spacers having an outer shape that holds the adjacent vertebral bodies at appropriate intervals by being inserted into the intervertebral disc space.
  • Correction and fixation / holding can be performed simultaneously in a short time at an appropriate interval between adjacent vertebral bodies in a surgical operation.
  • the operation time can be shortened as compared with the conventional interbody fusion surgery, thereby reducing the physical and mental burden of medical staff including patients and doctors, the surgical invasion of the patient, and the economic burden. .
  • FIG. 3 is an AA arrow view of FIG. 2.
  • A is a cross-sectional view taken along the line BB in FIG. 2
  • (b) is a cross-sectional view taken along the line CC in FIG. (A), (b), (c), (d), (e), (f) is a partial sectional view showing a concept of a pin of another modified embodiment of the present invention.
  • FIG. 3 is a sectional view taken along the line DD in FIG.
  • FIG. 3 is a plan view of FIG. 2. It is a longitudinal cross-sectional view (main part cross section) which shows the insertion state between the vertebral bodies of the interbody fixing device main body of FIG.
  • FIG. 3 is a longitudinal sectional view (main section) showing a state of fixation between vertebral bodies of the interbody fusion device of FIG. 2.
  • FIG. 10 is an EE arrow view of FIG. 9. It is a longitudinal cross-sectional view (main part cross section) which shows the fixation completion state between the vertebral bodies of the interbody fixing device of another embodiment (Example 2) of this invention.
  • FIG. 12 is an FF arrow view of FIG. 11.
  • FIG. 15A is a cross-sectional view taken along the line GG of the friction plate portion of FIG. 15, and FIG. 15B is a cross-sectional view taken along the line HH of FIG.
  • FIG. 15B is a cross-sectional view taken along the line HH of FIG.
  • FIG. 15B is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 5) of this invention.
  • FIG. 21 is an RR arrow view of FIG. 20. It is a top view of FIG. It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 7) of this invention.
  • (A) is the longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 8) of this invention,
  • (b) is II arrow view required of (a).
  • FIG. 28 is a view taken from the direction of the arrows U-U in FIG. 27.
  • FIG. 32 is a view on arrow VV of FIG. 31.
  • FIG. 34 is a plan view (upper half section) of the interbody space holding device of FIG. 33.
  • FIG. 35 is a view on arrow WW in FIG. 34.
  • FIG. 34 is a longitudinal cross-sectional view (upper half part cross section) which shows the concept of the main body insertion driver of one Embodiment of this invention.
  • FIG. 37 is a view taken along the line SS of FIG. 36. It is a side view which shows the concept of the press screw driver of one Embodiment of this invention.
  • FIG. 39 is a view on arrow TT in FIG. 38. It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fusion surgery system of the deformation
  • (A) is a side view conceptually showing a patient's lithotripsy state in the interbody fusion surgery of one embodiment of the present invention, and
  • (b) is a conceptual view of a patient's Trendelenburg position following (a).
  • FIG. 45 is a view on arrow XX in FIG. 44. It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 12) of this invention.
  • FIG. 45 is a view on arrow XX in FIG. 44.
  • FIG. 47 is a view on arrow YY in FIG. 46. It is a perspective view of the conventional interbody fusion device of the first example. It is a longitudinal cross-sectional view (main part cross section) of the state by which the conventional interbody fixing device of the 2nd example was fixed between vertebral bodies. It is a perspective view of the conventional typical interbody space holding
  • FIG. 52 is a side view showing a state in which the interbody space holding device (ventral ventral lordosis extending external sleeve) of FIG. 50 is inserted between vertebral bodies.
  • FIG. 1 is a longitudinal sectional view (main section) showing a main configuration concept of an interbody fusion surgical system according to an embodiment (Example 1) of the present invention
  • FIG. 2 is an intervertebral body of Example 1 of the present invention
  • FIG. 3 is a sectional view taken along the line AA in FIG. 2
  • FIGS. 4A and 4B are sectional views taken along the line BB in FIG.
  • FIGS. 5A, 5B, 5C, 5C, 5D, 5E, 5F, and 5F are cross-sectional views taken along arrows CC, respectively.
  • 6 is a cross-sectional view taken along the line DD of FIG. 2
  • FIG. 7 is a plan view of FIG. 2
  • FIG. 8 is a diagram showing a state where the interbody fusion device 10 is inserted between the vertebral bodies L1 and L2.
  • 9 is a longitudinal sectional view (cross section of the main part)
  • FIG. 9 is a longitudinal sectional view (cross section of the main part) showing a state of fixation between the vertebral bodies L1 and L2 of the interbody fusion device 10
  • Each drawing attached here is a conceptual diagram showing the main structural concept expressed in knot scale by enlarging the radial direction compared to the axial direction in order to make the internal structure easy to understand.
  • the interbody fusion surgical system is a male screw shape that is engaged and fitted between vertebral bodies L1 and L2 on a substantially hollow cylindrical outer surface having a front end.
  • Outer surface engaging portions 14 and 15 are formed, and one or a plurality of guide holes 17 and 18 penetrating from the inner surface of the female screw 16 provided on the rear end side hollow inner surface 16a to the outer surface so as to extend toward the vertebral body are formed.
  • the main body 11, one or a plurality of pins 30 loosely accommodated in the guide hole, and the female screw 16 are screwed together and the rear end of the pin is pressed so that the distal end side of the pin is inserted into the vertebral body along the guide hole.
  • An intervertebral body fixing device 10 that has a pressing screw 40 to be inserted and fits into an intervertebral disc space M between two adjacent vertebral bodies (vertebrae) L1 and L2, and fixes the vertebral bodies L1 and L2.
  • a cannula K inserted into the endoscope port Ma drilled from the side of the part MN1 toward the center between the vertebral bodies L1 and L2, and inserted into the cannula K, and an appropriate distance between the vertebral bodies L1 and L2
  • the interbody fixing device 10 is inserted into the hollow portion of the interbody space holding device 70, the main body 11 is pressed and rotated to be inserted between the vertebral bodies L1 and L2, and the intervertebral body fixing device 10 is inserted into the distal end engaging portion 93.
  • a press screw driver 90 is inserted into the hollow of the main body insertion driver 80 in a state of being engaged with the rear end engaging portion 44 of the press screw 40, and the press screw 40 is inserted into the female screw portion 16 of the main body 11 and screwed while being pressed. And.
  • an endoscope or a laparoscope or a main body is inserted through a plurality of endoscope abdominal cavity (not shown). It is desirable to provide a capsule endoscope or the like housed in the hollow of the driver 80.
  • the interbody fusion device 10 is formed in a substantially hollow cylindrical shape with a front end that fits an appropriate distance between the vertebral bodies L1 and L2, and the opposing surface of the vertebral bodies L1 and L2 on the outer surface.
  • the pin 3 is screwed into the female screw 16 and its axial propulsive force
  • the press screw 40 that presses the rear ends 31 and 31 of 0 and 30 is schematically configured.
  • the main body 11 has an outer shape formed so as to maintain an appropriate distance between the vertebral bodies L1 and L2, and the opposing surfaces L1a and L2a of the two vertebral bodies L1 and L2 are substantially parallel or dorsal.
  • a drum with a substantially hollow cylinder as shown in FIG. 1 whose outer diameter is slightly thicker, for example, on the order of 0.1 mm, so as to correspond to the case of an inclined surface shape of about 9 ° with respect to a horizontal plane. It is formed in a shape.
  • the main body 11 is accommodated between the vertebral bodies L1 and L2, for example, having an outer diameter of approximately 18 to 22 mm and a total length of approximately 25 to 45 mm, depending on the size of the vertebral bodies L1 and L2.
  • the front end surface 12 of the main body 11 is formed in a convex curved surface or a substantially conical surface not shown, and is disposed between the vertebral bodies L1 and L2 sufficiently in front of the nerve portion so as not to touch the nerve portion behind the spinal column. It is necessary.
  • the main body 11 is formed of a material having sufficient strength and biological compatibility to withstand a strong compressive force between the vertebral bodies L1 and L2, for example, on the order of 1000 kg, or an inert material.
  • these materials include porous materials such as medical grade stainless steel (SUS), titanium (Ti), and a porous tantalum composite material. Ti is particularly preferable from the viewpoint of strength and light weight.
  • External threads 14 and 15 are formed on the outer surface of the main body 11 as outer surface engaging portions in which the outer surface crown portion bites into and engages the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2. It is desirable that the valley diameter of the male screws 14 and 15 is substantially in contact with the distance between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2.
  • the thread height of the male screws 14 and 15 is, for example, about 3 to 4 mm.
  • the male screws 14 and 15 are desirably sufficiently engaged in the vertebral bodies L1 and L2 so that the main body 11 is not pushed out between the vertebral bodies L1 and L2 due to a high load applied to the spine.
  • the pitch of the male screws 14 and 15 is, for example, about 2 to 3 mm, depending on the amount of screw engagement required to hold the interbody fusion device 10 at a predetermined position between the vertebral bodies L1 and L2. Needless to say, the thread height and pitch of the male threads 14, 15 can be formed to a value smaller than the above as required.
  • the main body 11 is a substantially parallel cut side surface in which the tops on both the left and right sides of the rear outer surface are cut with an appropriate width, leaving the front end face 12 side. 19 and 19 are formed. Therefore, the male screw 15 on the front end face 12 side is a full screw, but the male screw 14 formed on the upper and lower outer surfaces of the cross-section partial cylinder in which the cut side faces 19 and 19 on the rear side are formed is a partial screw.
  • the axial front ends (screw ends) and the radial outer surface crests of the male screws 14 and 15 are formed in a sharp blade shape, and the male screw 15 which is a complete screw on the front end surface 12 side uses the main body 11 as a vertebral body L1. , L2 can be easily screwed in.
  • the main body 11 When the cut side surfaces 19 and 19 are formed over the entire length of the main body 11, the main body 11 can be easily inserted between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2 without screwing the main body 11 if the main body 11 is turned 90 ° in the figure. You can also In this case, the main body 11 is rotated 90 ° after being inserted between the vertebral bodies L1 and L2, and is held vertically so that the main body 11 maintains an appropriate distance between the vertebral bodies L1 and L2, as shown in FIG. Fixed.
  • the cut side surfaces 19 and 19 are suitable for providing a region for bone-like fixation by bone ingrowth between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2.
  • the rear end portions of the cut side surfaces 19 and 19 of the main body 11 are provided at the tip of the shaft of the transplant driver (not shown) when the interbody fusion device 10 is inserted and fixed between the vertebral bodies L1 and L2. It can also be held by a (holding tool).
  • a main body insertion driver according to an embodiment of the present invention in which the main body 11 is inserted between the vertebral bodies L1 and L2 will be described later.
  • a hollow inner surface 16a drilled from the rear end surface 13 side of the main body 11 is formed with a female screw 16 having an appropriate depth, and is substantially axisymmetric in the vertebral body L1 and L2 directions from the hollow inner surface 16a of the depth portion of the female screw 16.
  • a pair of upper and lower guide holes 17 and 18 penetrating to the outer surface along the inclined axes C2 and C3 of the inclination angles ⁇ 1 and ⁇ 2 with respect to the main axis C1 are formed at the end.
  • the inclination angles ⁇ 1 and ⁇ 2 are appropriately determined according to the arrangement state of the vertebral bodies L1 and L2 and the situation such as the thickness and flexibility of the pin 30, and both may be set to be substantially equal or slightly different inclination angles. Under the same conditions, the pushing force of the pin 30 tends to be substantially proportional to the inclination angles ⁇ 1 and ⁇ 2.
  • the inclined axes C2 and C3 are arranged in any direction and asymmetrically with respect to the main axis C1 as long as the distal end 32 of the pin 30 is not pushed and protrudes from the outer surface of the vertebral bodies L1 and L2.
  • it may be eccentric with respect to the main axis C1 and arranged in a plane in any direction.
  • the main body 11 has a plurality of openings such as side openings 21, 22, 23 and upper and lower openings 24, 25, 26.
  • a small hole 28 communicating with the side surface opening 21 and the upper and lower surface openings 24 is formed in the distal end surface of the hollow inner surface 16a.
  • the side openings 21, 22, 23 contact the highly vascularized tissue surrounding the vertebral bodies L1, L2 to promote angiogenesis, and the upper and lower surface openings 24, 25, 26 are opposite surfaces of the vertebral bodies L1, L2. Bone-like fixation by bone ingrowth is promoted between L1a and L2a. For this reason, it is desirable to drill a large number of openings in the main body 11 so as to communicate with each other as much as possible unless the strength is impaired.
  • the rear end surface 13 of the main body 11 has a pair of rear end openings 27 and 27 and a plurality of, for example, six partial arc-shaped openings formed along the circumferential portion.
  • This partial arc-shaped opening is a rear end engaging portion 29 in which a front end engaging portion of a main body insertion driver described later for fitting the main body 11 between the vertebral bodies L1 and L2 is engaged and engaged.
  • the rear end engaging portion 29 is provided with, for example, a hexagonal concave groove (not shown) on the rear end surface 13 in place of such a partial arc-shaped opening to engage the hexagonal front end engaging portion of the main body insertion driver. You may make it match.
  • the main body 11 is made of a porous tantalum-carbon composite material, for example, a porous material such as “HEDROCEL” (trade name of US Implex Co., Ltd.), the side openings 21, 22, 23 and the upper and lower surfaces as described above are used.
  • the openings 24, 25, and 26 may not be provided, and the interconnected porous portions may promote bone ingrowth and angiogenesis.
  • This porous material resembles the structure of a porous bone and has an elastic modulus close to that of a human bone, so it can be said to be optimal for the interbody fusion device of the present invention.
  • the pair of pins 30, 30 are loosely accommodated in the female screw 16 in parallel in the direction of the main axis C ⁇ b> 1, the rear end 31 side extends along the main axis C ⁇ b> 1 of the main body 11, and the front end 32 side is a pair each. It is guided along the guide holes 17 and 18, bent and inserted. Each tip 32 is appropriately sharpened, and in the initial state before the main body 11 is inserted between the vertebral bodies L1 and L2, the guide holes 17 and so on do not protrude from the valley diameter of the male screw 14, that is, from the valley diameter. It is accommodated in 18 outlets.
  • the pin 30 of this embodiment is formed of a solid or hollow rod-like body having an arbitrary cross-sectional shape such as a circle or a polygon. For example, as shown in FIGS. It is softer than the main body and is made of, for example, medical grade SUS having appropriate flexibility and strength.
  • the pin 30 which consists of a solid or hollow integrated rod-shaped body of this Example, and is a partial sectional view of the pin in the same direction as in FIG. 4A or FIG. )
  • a plurality of thin plate materials 30An, 30Dn or wire rods 30Bn, 30En, 30Cn, 30Fn having an arbitrary cross-sectional shape such as a round shape or various flat cross-sections are laminated and integrated at least over the tip side or the entire length.
  • the pins 30A, 30B, 30C, 30D, 30E, and 30F may be different from each other in the form of a rod-like laminate having an arbitrary cross-sectional shape such as a round shape or a polygonal shape.
  • the deformed pins 30A, 30B, and 30C each include a plurality of thin plate materials 30An, a round wire 30Bn, and an oval shape at least on the distal end side or the entire length.
  • the flat wire rods 30Cn are laminated to form a rod-like laminate having an integral substantially square cross section.
  • the deformed pins 30D, 30E, and 30F include a plurality of thin plate materials 30Dn and round wire rods 30En having different widths at least on the tip side or the entire length, respectively.
  • the oblong flat wire 30Fn is laminated to form a rod-like laminated body having a substantially rhombic cross section.
  • the deformed pins 30A, 30B, 30C, 30D, 30E, and 30F made of such a laminate are mutually connected to the thin plate members 30An and 30Dn or the wire rods 30Bn, 30En, 30Cn, and 30Fn at the base portion in order to maintain the shape. It is desirable to be integrally formed by bonding or welding to each other. As a result, since the thin plate members 30An, 30Dn or the wire rods 30Bn, 30En, 30Cn, 30Fn are in a free state, the distal end side is guided along the guide holes 17 and 18 of the main body 11 and can be bent relatively easily. Thus, the operability of being smoothly guided along the guide hole of the main body is improved. Further, the pins 30A to 30F made of these laminates can be easily laminated and formed in an arbitrary shape, and the degree of design freedom is improved.
  • the inner diameters of the female screw 16 and the hollow inner surface 16a are appropriately determined from the balance of the thickness of the pin 30 or 30A to 30F, the outer diameter of the main body 11, the strength of both, and the like.
  • the hollow inner surface 16a also serves as a pilot hole for the female screw 16.
  • the pressing screw 40 is a substantially disc flange having a size that covers the whole or part of the rear end surface 13 of the main body 11 at the rear end of the male screw portion 41 that is screwed into the female screw 16 of the main body 11.
  • a cap 42 is continuously provided.
  • the length of the male screw portion 41 from the surface where the cap 42 is provided corresponds to the pin 30 pressing stroke corresponding to the length of inserting the pin 30 into the vertebral bodies L1 and L2, and the pressing screw 40 is connected to the female screw 16 with the stroke screw. It is desirable to set so that the continuous surface of the cap 42 is in contact with the rear end surface 13 of the main body 11 when it is inserted.
  • the size of the cap 42 can be set so as to cover between the vertebral bodies L1 and L2 as necessary.
  • the material of the pressing screw 40 there are porous materials such as medical grade SUS, Ti, porous tantalum composite material, etc., as in the case of the main body 11.
  • Ti is a bone ingrowth in terms of strength and light weight.
  • a porous tantalum composite material or the like is preferable.
  • a cross groove 44 is formed on the rear end surface of the cap 42 as a rear end engaging portion that engages with a tip engaging portion of the transplant driver or a press screw driver described later.
  • the rear end engaging portion 44 may be formed with a hexagonal hole that engages with a distal end engaging portion formed in, for example, a hexagon wrench shape of a transplant driver or a pressure screw driver (not shown) instead of the cross groove. .
  • FIG. 27 is a longitudinal sectional view (upper half section) showing a concept of an interbody space holding device 70 for interbody fusion surgery according to an embodiment of the present invention
  • FIG. 28 is an interbody space holding device of FIG. 70 is a plan view (upper half section)
  • FIG. 29 is a view taken in the direction of arrows U-U in FIG.
  • An intervertebral body space holding device 70 includes a cannula K in an abdominal part Ma for endoscope provided on a living body abdominal part MN1 side with a grip 72 at a rear end (see FIG. 1).
  • the hollow long first shaft portion 71 inserted to the vicinity of the front surface of the vertebral bodies L1 and L2 via the vertebral body and the distal end portion 71a of the first shaft portion 71 are extended along the axial direction and are adjacent to the vertebrae.
  • a holding device having at least one pair of clamp arms 74 and 74 that can be opened and closed in the orthogonal planes of the vertebral bodies L1 and L2 with fixing claws 74b that clamp and fix the left and right side surfaces of the bodies L1 and L2 respectively. It consists of a main body 70a and a hollow long second shaft portion 76 which is fitted to the first shaft portion 71 so as to be movable forward / backward and provided with a gripping portion 77 at the rear end. A pair of clamp arms 74, 74 A clamp arm closing pipe 70b open to closed or expanded direction direction of reducing the diameter, made of.
  • a vertebral body clamping mechanism is constituted by the holding device main body 70a and the clamp arm opening / closing tube 70b.
  • the holding device main body 70a of this embodiment has the fixed claws 74b connected to the tip, the rear end connected to the tip 71a of the first shaft portion 71, and in the free state.
  • a pair of clamp arms 74 and 74 each having an elastic support portion 74a that is bent and elastically supported so as to expand and open the fixing claws 74b in the orthogonal planes of the vertebral bodies L1 and L2, respectively.
  • the clamp arm opening / closing pipe 70b is a contraction of the pair of clamp arms 74, 74 indicated by a two-dot chain line by the distal end portion 76a of the second shaft portion 76 moving forward and pressing the elastic support portion 74a from the outside.
  • the pair of clamp arms 74 and 74 are opened in a diameter increasing direction indicated by a two-dot chain line by closing in the radial direction and retreating the distal end portion 76a from the elastic support portion 74a.
  • Each of the pair of clamp arms 74, 74 is closed to the minimum when the position of the distal end portion 76a of the second shaft portion 76 in the C1 axis direction is X1 (fully closed position), and is X2 (vertebral body grasping / fixing position). Sometimes the left and right lateral surfaces of the vertebral bodies L1 and L2 are gripped / fixed, and open to the maximum at X3 (fully open position).
  • the vertebral body clamping surface of the fixed claw 74b has a plurality of sharp protrusions 74c that can be pierced on the left and right side surfaces of the vertebral bodies L1 and L2.
  • the holding device body 70a of this embodiment is opposed to the intervertebral space M along the axial direction at a slightly narrower distance than the outer diameter of the vertebral bodies L1 and L2 to the distal end portion 71a of the first shaft portion 71.
  • At least one pair of spacers 73 formed in an outer shape that extends in a state and is inserted into the intervertebral disc space M from the distal end portion so that the adjacent vertebral bodies L1 and L2 are corrected and held at appropriate intervals.
  • 73 are further provided.
  • the pair of spacers 73 and 73 and the pair of clamp arms 74 and 74 are provided in respective planes whose main axes are shifted by approximately 90 °.
  • Such a configuration of the holding device main body 70a simplifies the structure and operation, and the pair of spacers 73 and 73 are inserted into the intervertebral disc space M from the distal end, so that the adjacent vertebral bodies L1 and L2 are properly connected. Since the distance between the left and right side surfaces of the adjacent vertebral bodies L1 and L2 is held and fixed by the fixing claws 74b having a plurality of sharp protrusions 74c of each pair of clamp arms 74 and 74, respectively, while being corrected and held at intervals. In the interbody fusion surgery, it is possible to correct the distance between adjacent vertebral bodies L1 and L2 and to perform reliable fixation / retention simultaneously in a short time. As a result, the operation time can be shortened compared to the conventional interbody fusion surgery, so that the physical and mental burdens of medical staff including patients and doctors, the surgical invasion of patients, and the economic burden can be further reduced. it can.
  • FIG. 30 is a plan view (upper half section) showing a concept of an intervertebral body space holding device 70 ′ for interbody fusion surgery according to a modified embodiment of the present invention
  • FIG. 31 is an interbody space holding device of FIG. 70 'is a longitudinal sectional view (upper half section)
  • FIG. 32 is a view taken along arrow VV of FIG.
  • components having the same functions as those of the above-described embodiment are given the same reference numerals and symbols in order to simplify the description even if the dimensions and shapes are slightly different.
  • the interbody space holding device 70 ′ of this modified embodiment is similar to the first shaft portion 71 and the distal end portion 71 a of the first shaft portion 71 similar to that of the above-described one embodiment via the first support shaft P ⁇ b> 1.
  • a pair of clamp arms each having a fixed claw 74b that is pivotably overlapped and pivotally mounted in an orthogonal plane of the vertebral bodies L1 and L2, and is connected to the tip of the support portion 74'a.
  • the holding device main body 70'a having 74 'and 74' and the second shaft portion 76 and the intermediate portion of each pair of clamp arms 74 'and 74' on the side opposite to the overlapping surface as in the above embodiment Brackets in which one end portions are pivotably overlapped and pivotally mounted via the second support shafts P2 and P2, and the other end portions project from the tip end portion 76a of the second shaft portion 76.
  • 78 is pivotally overlapped with the third support shaft P3 so as to be swingable.
  • the clamp arm open tube 70'b having a link member 79, 79 of each pair which is composed of.
  • the holding device body 70'a and the clamp arm opening / closing tube 70'b constitute a vertebral body clamping mechanism.
  • the support portion 74'a is formed in a shape having high rigidity unlike the elastic support portion 74a having appropriate elasticity of the one embodiment, as shown in FIG. Further, as the second shaft portion 76 moves forward or backward, each pair of link members 79, 79 are swung counterclockwise or clockwise around the third support shaft P3 to each pair of clamp arms.
  • the toggle mechanism 74 ′, 74 ′ is closed in the reduced diameter direction indicated by the two-dot chain line or opened in the enlarged diameter direction with the first support axis P1 as a fulcrum within the orthogonal plane of the vertebral bodies L1, L2. .
  • Each pair of clamp arms 74 ′ and 74 ′ is closed to the minimum when the position of the distal end portion 76 a of the second shaft portion 76 in the C1 axis direction is X 1 ′ (fully closed position), and X 2 (vertebral body grasping / fixing) Position), the left and right lateral surfaces of the vertebral bodies L1 and L2 are gripped / fixed, and the X3 '(fully open position) opens to the maximum.
  • the vertebral body clamping mechanism including the holding device main body 70 ′ a and the clamp arm opening / closing tube 70 ′ b constitutes a toggle mechanism.
  • the clamping / fixing force between the left and right side surfaces of L1 and L2 is increased, and the reliability of the interbody space holding device can be further improved.
  • the interbody space holding device 70 ′ of this modified embodiment is similar to the adjacent vertebral body L 1, similar to the interbody space holding device 70 of the above embodiment, at the distal end portion 71 a of the first shaft portion 71. It further includes at least one pair of spacers 73 and 73 formed in an outer shape so that L2 is corrected and held at an appropriate interval.
  • the first and second shaft portions 71 and 76 of the interbody space holding devices 70 and 70 ′ of the one embodiment and the modified embodiment are both substantially oval, for example.
  • a hollow shape corresponding to the outer shape / size of the vertebral body such as a substantially elliptical or substantially rectangular cross section, or a substantially circular or substantially polygonal cross section (not shown).
  • the first shaft portion 71 is considerably larger than the shaft portion 81 of the main body insertion driver, the intervertebral body fixing device 10 or the intervertebral body is inserted into the first shaft portion 71.
  • a guide cylinder 71b (indicated by a two-dot chain line) having a relatively large inner diameter may be provided as necessary.
  • reinforcing plates 75 and 75 extending over the inner surfaces corresponding to the left and right clamp arms 74 and 74 at the tip of the first shaft portion 71 may be provided as necessary.
  • the distance between the reinforcing plates 75 and 75 is set to be slightly larger than, for example, at least about 2 mm from their maximum outer diameter so as not to interfere with the interbody fusion device 10 or the shaft portion 81.
  • FIG. 33 is a longitudinal sectional view (upper half section) showing the concept of an interbody space holding device 70 ′′ of still another modified embodiment of the present invention
  • FIG. 34 is an interbody space holding device 70 ′ of FIG. ′ ′ Plan view (upper half section)
  • FIG. 35 is a view taken along the line WW in FIG. 34.
  • components having the same functions as those of the embodiment described above are given the same reference numerals and symbols in order to simplify the description even if the dimensions are slightly different.
  • the intervertebral body space holding device 70 ′′ is provided with a grasping portion 72 at the rear end, and a cannula K (see FIG. 1) in the abdominal portion Ma for endoscope provided on the living body abdominal portion MN1 side.
  • a hollow long first shaft portion 71 ′ inserted to the vicinity of the front surface of the vertebral bodies L 1 and L 2 via the reference), and extended on the outer surface of the first shaft portion 71 ′ so as to be rotatable along the axial direction.
  • a long fixed screw member 76'b in which the screw portion 76'a formed at the tip is inserted into and fixed to one or both front surface portions of the adjacent vertebral bodies L1, L2, and the first shaft portion 71.
  • one or a plurality of needle-like protrusions 71c that can project into one or both front surface portions of the adjacent vertebral bodies L1 and L2.
  • the long fixing screw member 76'b is rotatably inserted into the insertion hole 75c of the rear support member 75a and the front support member 75b provided upright on the outer surface of the first shaft portion 71 '.
  • a driver or wrench engaging groove (not shown) or a head portion 76'c having a hexagonal outer shape is provided.
  • the long fixing screw member 76'b, the rear support member 75a, and the front support member 75b constitute a vertebral body fixing mechanism 76 ', and the first shaft portion 71' inserted into the cannula K is held at the rear end portion or gripped.
  • the elongated fixing screw member 76 ′ is inserted through the head 76′c. While pressing b, it is rotated clockwise, for example, and inserted into and fixed to one or both front portions of the vertebral bodies L1, L2.
  • the interbody space holding device 70 ′′ of this modified embodiment is adjacent to the vertebral body fixing mechanism 76 ′ and the needle-like protrusion 71 c provided on the outer surface of the first shaft portion 71 ′ and the distal end portion 71 ′, respectively.
  • the vertebral bodies L1 and L2 are fixed to each other by screwing and piercing into the front portions of the vertebral bodies L1 and L2, respectively, so that the structure and operation are simple. Since the vertebral bodies L1 and L2 to which a relatively large external force is applied when transplanted and fixed between the vertebral bodies L1 and L2 are not displaced rearward or left and right, the reliability of intervertebral body space retention in interbody fusion surgery Sex is secured.
  • the gripping portions 72 and 77 are boss portions 72a fitted to the rear ends of the first and second shaft portions 71, 71 'and 76, which are set to lengths that are sequentially exposed to the outside of the cannula K, respectively. , 77a and at least one handle or a plurality of handles (handles) standing upright, but can be formed in any other gripping shape (not shown) such as a known cylindrical type.
  • the rear members of the shaft portion excluding the distal ends of the first and second shaft portions 71, 71 ′, 76 and other clamp mechanisms, the vertebral body fixing mechanism 76 ′, the spacers 73, 73 ′, etc. It can be composed of a lightweight polymer material such as a resin. It is desirable that the interbody space holding devices 70, 70 ′, and 70 ′′ are composed of a combination of Ti and polymer materials that are as light as possible to reduce the overall weight and improve operability.
  • FIG. 36 is a longitudinal sectional view (upper half section) showing a concept of a main body insertion driver 80 according to an embodiment of the present invention
  • FIG. 37 is a view taken along the line SS of FIG. 36
  • FIG. 38 is an embodiment of the present invention.
  • FIG. 39 is a view taken along the line TT in FIG. 38.
  • the body insertion driver 80 is provided with a gripping portion 82 at the rear end, and the vertebrae are interposed through the first shaft portions 71 and 71 ′ of the interbody space holding devices 70, 70 ′ and 70 ′′.
  • a hollow long shaft portion 81 inserted to the vicinity of the front surfaces of the bodies L1 and L2, and a rear end engaging portion 29 (formed on the rear end surface 13 of the body 11 of the interbody fusion device 10 at the distal end of the shaft portion 81) 3) and a tip engaging portion 83 that engages.
  • the gripping part 82 is attached to the rear end of the shaft part 81 set to a length exposed to the outside of the rear end of the first shaft parts 71, 71 ′ of the interbody space holding devices 70, 70 ′, 70 ′′. It is formed in the shape of at least one pair or a plurality of handles (handles) standing on the fitted boss portion 82a.
  • the front end engaging portion 83 is formed in a plurality of partial arcuate claw shapes that are engaged with and engaged with the partial arc-shaped rear end engaging portion 29 (FIG. 3) of the main body 11, and the front end of the nail
  • the portion has a shape that can be easily fitted into the rear end engaging portion 29, such as a corner portion being cut.
  • the front end engaging portion 83 is formed in a shape that matches the arbitrary shape of the rear end engaging portion 29.
  • the tip engaging portion 83 is made of a hard metal such as SUS or Ti, and the shaft portion 81 can be made of a light polymer material such as a resin. It is desirable that the main body insertion driver 80 is lightened as a whole, for example, to be constructed by combining Ti and polymer materials that are as light as possible to improve operability.
  • the pressing screw driver 90 is provided with a grip portion 92 at the rear end, and a long shaft portion 91 inserted into the vicinity of the front surface of the vertebral bodies L1 and L2 through the shaft portion 81 of the main body insertion driver 80, and the shaft portion
  • the front end 91 includes a front end engaging portion 93 that engages with a rear end engaging portion 44 (FIG. 10) formed at the rear end portion of the cap 42 of the pressing screw 40.
  • the grip portion 92 is at least one pair or a plurality of handles (e.g., standing on a boss portion 92a fitted to the rear end of the shaft portion 91 set to a length exposed to the outside of the rear end of the main body insertion driver 80. It is formed in a handle shape. That is, as shown in FIG. 1, the pressing screw driver 90 is exposed to the outside from the rear end surface of the main body insertion driver 80 when the intervertebral body fixing device 10 is fixed between the vertebral bodies L1 and L2, and is held by the grip portion 92. It has a sufficient length that can be gripped.
  • the front end portion 93a of the front end engaging portion 93 is formed, for example, in the shape of a plus driver that engages with the rear end engaging portion 44 (FIG. 10) of the pressing screw 40.
  • the front end 93a is shaped like a hexagon wrench that engages with the hexagonal hole. It is formed in a shape (not shown) that fits any shape of the engaging portion 44.
  • the tip engaging portion 93 is made of a hard metal such as SUS or Ti, and the shaft portion 91 can be made of a light polymer material such as a resin. It is desirable that the pressure screw driver 90 is lightened as a whole including the shaft portion 91 formed in a hollow shape to improve operability.
  • the gripping portions 82 and 92 can be formed in any other gripping shape (not shown) such as a known cylindrical shape.
  • FIG. 40 shows a conceptual longitudinal cross-sectional view (cross-section of the main part) of the interbody fusion surgery system of the modified embodiment to which the interbody space holding device 70 ′′ of the modified embodiment is applied.
  • the interbody fusion device 10 is formed from the abdominal MN1 side to the front surface of the spine. While observing with an endoscope (or a laparoscope) (not shown) or the capsule endoscope through a cannula K in the abdominal cavity Ma for endoscope, the interbody space holding device 70, the body insertion driver 80, and a pressing screw An intervertebral body fixing surgical method that uses a screwdriver 90 to fit into the intervertebral disc M between the vertebral bodies L1 and L2 and fixes the vertebral bodies L1 and L2 will be described as a main feature.
  • vertebral body fixation device 10 Prior to surgery, after the patient's optimal vertebral body fixation device 10 dimensions and desired distraction have been evaluated, the patient is distracted and the vertebral body (vertebral) alignment corrected simultaneously as shown in FIG. 41 (a).
  • Human body MN including arms and legs so that the shoulder is not lowered to the head side in a so-called crushed position where the legs are bent upwardly on the spinal table Bd To fix.
  • the spinal table Bd is tilted, the foot is raised and the head is lowered, so that the head is lowered and the waist is in the Trendelenburg state, and the following operation is started.
  • laparoscopic ports Ma, Mb, Mc, Md, and a plurality of incision wounds Mf of about several millimeters are provided at predetermined positions of the abdominal part MN1, for example, with an electric knife.
  • an insufflation gas such as CO2 is supplied into the abdominal cavity through a puncture needle such as an access needle. inject.
  • the port Ma is a main laparoscopic port for inserting the interbody fusion device 10 and is arranged so as to aim at a substantially central portion between the vertebral bodies L1 and L2.
  • the port Mb is disposed on the central axis of the abdominal part MN1, for example, a few millimeters to 10 cm from the navel near the head.
  • the abdominal wall is disposed on the side of the upper abdominal vessel opposite to the vertebral bodies L1 and L2.
  • the ports Mc and Md are arranged slightly shifted so as to face each other on the left and right sides of the port Mb.
  • An appropriate retractor (forceps) (not shown) is inserted through the ports Mc and Md, and a treatment for appropriately separating the internal organs from the periphery of the target vertebral body is performed.
  • pretreatment step a pretreatment such as pushing a bone margin such as a dural capsule and a transverse nerve root (not shown) to the side is performed (pretreatment step).
  • a treatment trocar sleeve Tr such as a verse step or a bar support is disposed in the port Ma portion.
  • the hollow cannula (or power shield sleeve) K which is the outer cylinder of the trocar sleeve Tr, after the puncture needle and the puncture needle are removed, various treatment tools Tp described later are inserted up to the spinal column (spine) L portion.
  • FIGS. 27 and 28 a pair of clamp arms to the vicinity of the front surfaces of the vertebral bodies L1 and L2 through a cannula K inserted into the endoscope port Ma provided on the abdominal part MN1 side.
  • the intervertebral space holding device 70 with 74 and 74 closed is inserted, and a pair of spacers 73 and 73 are inserted into the intervertebral disc space M from the tip to correct the adjacent vertebral bodies L1 and L2 to an appropriate interval.
  • the pair of clamp arms 74 and 74 are opened and closed again so as to sandwich the left and right side surfaces of the adjacent vertebral bodies L1 and L2 by the fixing claws 74b, respectively, via a plurality of sharp protrusions 74c ( Piercing) and fixing (interbody space holding process).
  • the opening / closing operation of each pair of clamp arms 74, 74 is performed by moving the clamp arm opening / closing pipe 70b backward or forward as described above.
  • a transplant driver drill or a hollow tubular tube is used by using an endoscope (or a laparoscope) inserted into the first shaft portion 71 of the interbody space holding device 70 from the abdominal part MN1 side.
  • an endoscope or a laparoscope
  • a cutter perforator
  • a pilot hole having an outer diameter slightly narrower than the outer diameter of the main body 11 of the vertebral body fixing device 10 is drilled to an appropriate depth in the intervertebral disc space M between the vertebral bodies L1, L2. Installation process).
  • the first shaft of the interbody space holding device 70 from the abdomen MN1 side with the rear end engaging portion 29 of the main body 11 engaged with the front end engaging portion 83 of the main body insertion driver 80. It is inserted into the portion 71, and the main body 11 is pressed and rotated to be screwed and fixed to a predetermined position of the lower hole in the intervertebral disc space M (main body inserting step). At this time, as shown in FIG. 8, the main body 11 is screwed into the outer surface tops of the male screws 14 and 15 by biting into and engaging with the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2.
  • the shaft portion 81 of the body insertion driver 80 from the abdomen MN ⁇ b> 1 side in a state where the rear end engagement portion 44 of the press screw 40 is engaged with the front end engagement portion 93 of the press screw driver 90. It is inserted into the internal threaded portion 16 of the rear end surface 13 of the main body 11 which is inserted and fixed between the vertebral bodies L1 and L2, and is rotated and screwed in while pressing, and 1 at the tip 43 surface of the male threaded portion 41.
  • the rear surfaces 31, 31 of the pair of pins 30, 30 are pressed so that the tips 32, 32 side of the pins 30, 30 are guided along the guide holes 17, 18 of the inclination angles ⁇ 1, ⁇ 2, respectively, and are bent sequentially.
  • the surfaces L1a and L2a are inclined and inserted into the vertebral bodies L1 and L2 (pin insertion and fixing step).
  • the press screw 40 is held by the cap 42 continuous surface of the main body 11 while being sufficiently pressed and held by hand or mechanical rotation restraining means (not shown) so as not to rotate the gripping portion 82 of the main body insertion driver 80. Screw into the internal thread 16 up to a predetermined trowel contacting the rear end face 13.
  • the cap 42 finally comes into contact with the rear end surface 13 of the main body 11, thereby defining the screwing allowance of the pressing screw 40 into the main body 11 for a predetermined stroke and the reverse rotational frictional force of the pressing screw 40. Therefore, it has the effect of preventing the reverse rotation of the pressing screw 40 and the effect of preventing the pin 30 from coming off.
  • the interbody fusion device 10 is a small size having an outer shape adapted to an appropriate distance between the vertebral bodies L1 and L2, and after the main body 11 is screwed between the vertebral bodies L1 and L2, the pressing screw 40 is used. Is simply bent into the female screw 16 of the main body 11 and is bent along the guide holes 17 and 18 from the tip 32 of the pin 30 that is pressed, and is inserted into the vertebral bodies L1 and L2 and fixed.
  • the interbody fusion treatment can be easily performed in a short time only by screwing around one axis from the direction of the main axis C1.
  • the interbody fusion surgery system, the surgical method, and the interbody space holding device of the present invention are greatly reduced in operation scale as compared with the conventional interbody fusion surgery, and operated. Since both the time and the recovery period can be greatly shortened, the physical and mental burdens of medical staff including patients and doctors, surgical invasion of patients, and economic burdens can be significantly reduced. Then, the pin 30 inserted and fixed in the vertebral bodies L1 and L2 can prevent the body 11 from retreating or rotating from the proper position, and the intervertebral body fixing reliability is ensured.
  • the intermediate fixing structure and operation are greatly simplified and compact, and the operability and economy are more advantageous.
  • FIG. 11 is a longitudinal cross-sectional view (main part cross-section) showing the state of fixation between the vertebral bodies L1 and L2 of the interbody fusion device 10a according to another embodiment (Example 2) of the present invention, and FIG. FIG.
  • the interbody fusion device 10a of the second embodiment is engaged with and fixed to the front surface portions of the adjacent vertebral bodies L1 and L2 loosely fitted to the pressing screw 50 with respect to the interbody fusion device 10 of the first embodiment.
  • the configuration is exactly the same as that of the first embodiment except that a fixing reinforcing tool 60 for reinforcing fixation between the vertebral bodies L1 and L2 is added. Accordingly, here, the same reference numerals are given to the constituent members having the same functions as those in the first embodiment even if the shapes are slightly different.
  • the pressing screw 50 has the same configuration as that of the pressing screw 40 in the interbody fusion device 10 of the first embodiment, but the male screw portion 51 that is screwed into the female screw 16 of the main body 11 has a fixed reinforcing tool 60 as compared with the pressing screw 40. The only difference is that it is longer by adding.
  • a cross groove 54 as shown in FIG. 12 is formed on the rear end surface of the cap 52 of the press screw 50 so that the tip engagement portion 93 of the press screw driver 90 is engaged.
  • a hexagonal hole having a concave groove shape with which an engaging portion 93 formed in a hexagonal wrench shape may be formed.
  • the fixed reinforcing member 60 is provided with a boss 61 that is loosely fitted to the male screw portion 51 of the pressing screw 50, and is vertically provided on the outer surface of the boss 61 so as to be vertically symmetrical, and the rear end surface of the boss 61 portion is pressed against the cap 52 portion of the pressing screw. And a pair of arms 62 and 62 that are engaged and fixed to the front portions of the adjacent vertebral bodies L1 and L2, respectively.
  • the material of the fixing reinforcing member 60 there are medical grade SUS, Ti, etc., as in the case of the main body 11, and Ti is particularly suitable from the viewpoint of strength and light weight.
  • the arm 62 is provided on the rear end side of the cap 52 side, and is erected on the outer surface of the boss 61 along the plate-like flange 62a whose tip is bent by approximately 90 ° toward the vertebral bodies L1 and L2, and the plate-like flange 62a.
  • the web 62b is formed in a substantially T-shaped cross section.
  • the distal end portion of the distal end of the arm 62 is formed in a tapered shape so as to be easily engaged with and fixed to the abdominal side surfaces of the vertebral bodies L1 and L2.
  • the distal end portion of the arm 62 of the fixed reinforcing tool 60 is appropriately positioned from the opposing surfaces L1a and L2a of the front surface portions of the adjacent vertebral bodies L1 and L2. Engage substantially T-shaped engaging grooves L1b and L2b to be engaged (fixed reinforcement engaging groove engaging step).
  • the pressing screw 50 is held by the cap 52 continuous surface while the pressing screw 50 is firmly pressed and held by hand or mechanical rotation restraining means (not shown). Screw into the internal thread 16 up to a predetermined trowel that contacts the rear end surface of the boss 60.
  • the interbody fixing method includes at least a pretreatment process, an intervertebral body space holding process, a pilot hole drilling process, a main body insertion process, a fixing reinforcement engaging groove drilling process, pin insertion, and fixing reinforcement. It has a tool fixing process.
  • the interbody fusion surgical system and the surgical method using the interbody fusion device 10a of the second embodiment have the same advantages as those of the first embodiment, and in addition, the fixation is loosely fitted to the pressing screw 50.
  • the distal ends of a pair of arms 62 of the reinforcing tool 60 are engaged with and fixed to the front portions of the adjacent vertebral bodies L1 and L2 by pressing the rear end surface of the boss 61 against the cap portion 52 of the pressing screw 50, respectively. Therefore, since the interbody fusion is strongly reinforced by a simple operation, the reliability of the interbody fusion can be easily improved.
  • the arm 62 can be provided with appropriate rigidity, and the reverse reaction force of the pressing screw 50 is increased and held by the rigidity reaction force. The retaining effect can be further improved.
  • FIG. 13 is a longitudinal sectional view (main part sectional view) showing a concept of an interbody fusion device 10b of still another embodiment (Example 3) of the present invention
  • FIG. 14 is a view taken along the line PP in FIG. .
  • the interbody fusion device 10b of the third embodiment is different from the interbody fusion device 10 of the first embodiment only in that the outer shape of the main body 11b is substantially tapered and formed into a hollow truncated cone shape.
  • the configuration is exactly the same as in the first embodiment. Therefore, the same reference numerals are given to constituent members having the same functions as those in the first embodiment even if the shapes are slightly different, and the description thereof will be omitted because they are duplicated.
  • the outer shape of the main body 11b of Example 3 is formed in a substantially tapered truncated cone shape having a taper along its length at an angle corresponding to the normal anterior bay posture angle of the lower vertebral body L2, for example, approximately 9 °.
  • the frustoconical taper angle of the main body 11b widens so that the adjacent vertebral bodies L1 and L2 form an appropriate front bay posture angle when the main body 11b is fitted in a predetermined position over the outer diameters of the front end and the rear end.
  • a quantity can be defined.
  • FIG. 15 is a longitudinal sectional view (main part sectional view) showing a concept of an interbody fusion device 10c of still another embodiment of the present invention (Example 4), and FIG. 16 (a) is a friction plate 55 of FIG.
  • FIG. 5B is a cross-sectional view taken along the line GG of FIG. 5B, and FIG.
  • the interbody fusion device 10c according to the fourth embodiment is loosely accommodated in the female screw 16 of the main body 11b with respect to the interbody fusion device 10b according to the third embodiment, and is provided at the rear ends 31 and 31 of the pins 30 and 30.
  • the rest of the configuration is exactly the same as that of the third embodiment, except that a friction plate 55 arranged in contact is added. Accordingly, here, the same reference numerals are given to the structural members having the same functions as those in the third embodiment even if the shapes are slightly different.
  • the friction plate 55 has a pair of appropriate depths for fitting the pin rear ends 31, 31 on the contact surface side with the pin rear ends 31, 31b.
  • the pin fixing grooves 55a and 55a are formed.
  • the friction plate 55 is fixed to the pin rear ends 31 and 31 by welding or bonding without providing the pin fixing groove 55a. Also good.
  • the friction plate 55 may be simply placed in contact with the pin rear ends 31, 31 without using the pin fixing groove 55a or the movement restraining means of the pin rear ends 31, 31 such as fixing. .
  • the pin rear end 31, 31 part of the pressing screw 40 or 50 is pressed via the friction plate 55, and therefore the pressing screw 40 or 50 and the pin rear end 31 are pressed.
  • the pin rear end 31, 31 surface is not directly subjected to the rotational force of the pressing screw 40 or 50 and the pin rear end 31, 31 portion is in contact with the inner surface of the female screw 16 portion of the main body 11b.
  • the pressing screw 40 or 50 is screwed into the female screw 16 with a small torque and the pin 30 is smoothly pushed forward without almost receiving the force of sliding (moving away) in the lateral direction with many gaps. Is possible.
  • FIG. 17 is a longitudinal sectional view (main part sectional view) showing the concept of an interbody fusion device 10d according to another embodiment of the present invention (Example 5), and FIG. 18 is a view taken along the line QQ of FIG. 19 is a plan view of FIG.
  • the outer surface engaging portion 14 of the main body 11 in the interbody fusion device 10 of the first embodiment is formed in a male screw shape, whereas the outer surface engagement of the main body 11d.
  • the configuration is exactly the same as that of the first embodiment except that the portion 14a is formed in a plurality of spline teeth parallel to the main axis C1. Therefore, the same reference numerals are given to constituent members having the same functions as those in the first embodiment even if the shapes are slightly different, and the description thereof will be omitted because they are duplicated.
  • the outer surface engaging portion 14a is formed in a plurality of spline teeth parallel to the main shaft C1
  • the main bodies 11 and 11b in the first to third embodiments can be screwed only by pressing the main body 11d. Since the rotation operation can be omitted, the vertebral bodies L1 and L2 can be fitted and fixed in a short time, and the operability is improved.
  • the radial outer surface vertex and axial tip of the spline teeth that are the outer surface engaging portion 14a are formed in a sharp blade shape, and can be easily fitted between the vertebral bodies L1 and L2 by pressing the main body 11d. be able to.
  • FIG. 20 is a longitudinal sectional view (major section) showing a concept of an interbody fusion device 10e of another embodiment of the present invention (Example 6), and FIG. 21 is a view taken along the line RR of FIG. 22 is a plan view of FIG.
  • the outer surface engaging portion 14b of the main body 11d in the interbody fusion device 10d of the fifth embodiment is formed in a spline shape, whereas the outer surface engagement of the main body 11e. Except for the point that the joint portion 14c is formed in a plurality of sawtooth shapes parallel to the main axis C1, the rest of the configuration is exactly the same as in the first or fifth embodiment. Therefore, the same reference numerals are given to the constituent members having the same functions as those in the first or fifth embodiment even if the shapes are slightly different, and the description thereof is omitted because it is duplicated.
  • the outer surface engaging portion 14a is formed in a plurality of sawtooth shapes parallel to the main shaft C1, the rotation for screwing the main bodies 11, 11b in the first to third embodiments just by pressing the main body 11e. Since the operation can be omitted, the vertebral bodies L1 and L2 can be inserted and fixed in a short time, and the operability is improved.
  • the vertebral body is pressed by pressing the main body 11e.
  • L1 and L2 it is possible to secure the reliability of fixing by preventing the main body 11e from coming off.
  • FIG. 23 is a longitudinal sectional view (major section) showing the concept of an interbody fusion device 10f according to another embodiment (Example 7) of the present invention.
  • the interbody fusion device 10f according to the seventh embodiment is different from the interbody fusion device 10 according to the first embodiment in that the pin 30a has a relatively short straight shape and the tip of the pressing screw 40a.
  • the configuration is the same as that of the first embodiment except that the shape of 43a is different. Therefore, the same reference numerals are given to constituent members having the same functions as those in the first embodiment even if the shapes are slightly different, and the description thereof will be omitted because they are duplicated.
  • the pair of pins 30a and 30a of the seventh embodiment are formed in a relatively short straight shape, and are loosely accommodated in the pair of guide holes 17 and 18, respectively.
  • Each tip 32a is formed in a sharp shape as appropriate, and in the initial state before the main body 11 is inserted between the vertebral bodies L1 and L2, as shown by the two-dot difference line in FIG. That is, it is accommodated in the outlets of the guide holes 17 and 18 so as not to protrude from the valley diameter.
  • the pressing screw 40a has a male screw portion 41 and a cap 42 having the same shape as the pressing screw 40 of the first embodiment, but the distal end portion 43a of the male screw portion 41 extends in a round bar shape slightly thinner than the hollow inner surface 16a.
  • An inclined surface 43a is formed that is cut so that the corners of the front end are in contact with the rear ends 31a and 31a of the pins 30a and 30a.
  • FIG. 24 (a) is a longitudinal sectional view (main section) showing the concept of an interbody fusion device 10g according to another embodiment (Example 8) of the present invention, and FIG. It is I arrow principal part sectional drawing.
  • the interbody fusion device 10g according to the eighth embodiment has a relatively long straight shape with respect to the interbody fusion device 10e according to the seventh embodiment, and a pair of pins 30b.
  • the rest of the configuration is exactly the same as that of the seventh embodiment except that the arrangement of the pair of guide holes 17a and 18a for accommodating 30b is different. Therefore, the same reference numerals are given to the structural members having the same functions as those in the seventh embodiment even though the shapes are slightly different, and the description thereof will be omitted because they are duplicated.
  • the pair of pins 30b and 30b of the eighth embodiment are formed in a relatively long straight shape and are loosely accommodated in a pair of guide holes 17a and 18a, which will be described later.
  • Each tip 32b is appropriately sharpened, and in the initial state (standby position) before the main body 11 is inserted between the vertebral bodies L1 and L2, as shown by the two-point difference line in FIG. It is accommodated in the outlets of the guide holes 17a and 18a within the valley diameter of the male screw 14, that is, so as not to protrude from the valley diameter.
  • the pins 30b and 30b accommodated in the pair of guide holes 17a and 18a provided in the main body 11g are arranged eccentrically with respect to the central axis of the main body 11g, for example. . Thereby, the mutual interference of the rear ends 31b and 31b at the standby position of the pair of pins 30b and 30b can be avoided.
  • the inclined axes C2 and C3 which are the central axes of the pair of guide holes 17a and 18a, are arranged in a plane substantially parallel to the central axis, but the tip 32b of the pin 30b is pushed in.
  • they may be arranged in any direction and asymmetrically with respect to the main axis C1, or they are eccentric with respect to the main axis C1 and arranged in a plane in any direction. Also good.
  • FIG. 25 is a longitudinal sectional view (major section) showing the concept of an interbody fusion device 10h according to another embodiment (Example 9) of the present invention.
  • the shape of the pair of pins 30c and 30c and the guide holes 17c and 18c is gentler toward the distal end than the interbody fusion device 10g according to the eighth embodiment.
  • the rest of the configuration is exactly the same as that of the eighth embodiment except that it is formed in a concave arc or curve. Therefore, the same reference numerals are given to the structural members having the same functions as those of the eighth embodiment even if the shapes are slightly different, and the descriptions thereof are omitted because they are duplicated.
  • a pair of concave arcs or curved guide holes 17c, 18c provided in the main body 11h is provided on the main body 11h so as to avoid mutual interference between the rear ends 31c, 31c at the standby position of the pair of pins 30c, 30c.
  • the pin 30c can be arranged along an arbitrary direction as long as the tip 32c of the pin 30c is pushed and does not protrude from the outer surface of the vertebral bodies L1 and L2 with respect to the central axis.
  • FIG. 26 is a longitudinal sectional view (major section) showing the concept of an interbody fusion device 10i of still another embodiment (Example 10) of the present invention.
  • the shape of the pair of pins 30d and 30d and the guide holes 17d and 18d is gentler toward the distal end than the interbody fusion device 10h of the ninth embodiment.
  • the rest of the configuration is exactly the same as that of the ninth embodiment except that it is formed in a convex arc or curve. Therefore, the same reference numerals are given to the structural members having the same functions as those in the ninth embodiment even if the shapes are slightly different.
  • the pair of convex arcs or curved guide holes 17d and 18d provided in the main body 11i avoids mutual interference between the rear ends 31d and 31d at the standby position of the pair of pins 30d and 30d.
  • it can be arranged along any direction as long as it is decentered, for example, left and right with respect to the central axis of the main body 11i and the tip 32d of the pin 30d is pushed and does not protrude from the outer surface of the vertebral bodies L1 and L2. .
  • FIG. 44 is a longitudinal sectional view (main section) showing the concept of an interbody fusion device 10j according to still another embodiment (Example 11) of the present invention
  • FIG. 45 is a state in which the pressing screw 40j of FIG. 44 is removed.
  • the interbody fusion device 10j according to the eleventh embodiment is integrated with the base end portion 33 in which a pair of pins 30j and 30j are provided with a female screw hole 34 at the rear end of the interbody fusion device 10 according to the first embodiment.
  • the press screw 40j is provided with an insertion hole 44 that is coaxial with the female screw hole 34 of the base end 33, and the other configuration is exactly the same as in the first embodiment. is there. Accordingly, here, the same reference numerals are given to the constituent members having the same functions as those in the first embodiment even if the shapes are slightly different.
  • the pressing screws 40 and 40j of the above embodiments including this embodiment are moved from the main body 11 to 11i by the rotation operation in the direction opposite to the screwing direction into the main bodies 11 to 11i, and the main bodies 11 to 11i are intervertebral bodies. It can be removed from between the vertebral bodies by rotation and / or extraction operation in the direction opposite to the direction of insertion into the body, and can be taken out of the body.
  • the interbody fusion device 10j is configured so that the pressing screw 40j is attached to the main body 11 when an unexpected suppuration disorder due to infection or the like occurs after being fixed between the vertebral bodies via the pins 30j and 30j. Can be pulled out from the vertebral body by a pulling driver 95 having a male screw portion 95a for screwing the pins 30j and 30j into the female screw hole 34 of the base end portion 33 and taken out of the body together with the main body 11. Thereafter, the intervertebral body fixing device 10j can be re-fixed between the vertebral bodies after a treatment such as filling the vertebral bodies with antibiotics or aggregates if necessary.
  • the pressing screw 40j does not have to be completely removed from the main body 11.
  • the extraction screwdriver 95 can be inserted into the insertion hole 4 provided in the pressing screw 40j and the male screw portion 95a at the distal end portion can be screwed into the female screw hole 34 of the base end portion 33 of the pin 30j.
  • the pins 30j and 30j can be extracted from the vertebral body by the above-described extraction operation and taken out of the body together with the main body 11.
  • a blind plug (not shown, male screw portion 95a in FIG. 44) having an engaged portion such as a plus driver groove or a hexagonal hole at the rear end portion is usually provided. Is inserted and the blind plug is inserted by a screwdriver (not shown) having an engaging portion at the tip thereof that engages with the engaged portion prior to the pulling operation of the pins 30j and 30j. It can be removed from the female screw hole 34 and taken out of the body.
  • the blind plug inserted in the female screw hole 34 of the base end portion 33 of the pin 30j so as to be able to be taken out prevents foreign matter such as intervertebral spinal fluid or bone forming material from entering the female screw hole 34.
  • the extraction driver can be easily and quickly screwed into the female screw hole at the base end portion of the pin, and the operability of removing the interbody fusion device 10j is improved.
  • the blind plug inserted in the female screw hole 34 is inserted into the insertion hole 44 of the pressing screw 40j in a state of being screwed into the female screw 16 of the main body 11, and the driver (not shown) is inserted through the blind plug. It can be detached from the female screw hole 34 by engaging with the engaged portion at the end.
  • the pins 30j and 30j are mounted in the female screw 16 of the main body 11 with the blind plug inserted in the female screw hole 34 first, and the interbody fusion device At the time of removal, it is possible to sequentially take out the blind plug and the pins 30j and 30j after taking out the pressing screw to the outside.
  • FIG. 46 is a longitudinal cross-sectional view (main cross-sectional view) showing a concept of an interbody fusion device 10k according to still another embodiment (Example 12) of the present invention
  • FIG. 47 is a state in which the pressing screw 40k of FIG. 46 is removed.
  • the interbody fusion device 10k according to the twelfth embodiment is different from the interbody fusion device 10j according to the eleventh embodiment in that the pair of pins 30k and 30k each have a base end portion 33k provided with a female screw hole 34k at the rear end.
  • the press screw 40k is provided with a pair of insertion holes 45, 45 coaxial with the female screw hole 34k of the base end portion 33k, respectively, except that the pressing screw 40k is provided in a continuous manner.
  • the configuration is exactly the same. Therefore, here, the same reference numerals are given to the structural members having the same functions as those of the eleventh embodiment even if the shapes are slightly different.
  • pressing screw 40k of this embodiment is also rotated and pulled out from the inside of the main body 11 in the direction opposite to the screwing direction into the main body 11, and the main body 11 is also rotated in the direction opposite to the fitting direction between the vertebral bodies. It can be removed from between the vertebral bodies by the operation and can be taken out of the body.
  • the pressing screw 40k is attached to the main body 11 in the event that an unexpected suppuration disorder due to infection or the like occurs after being fixed between the vertebral bodies via the pins 30k, 30k. And the pins 30k and 30k are pulled out from the vertebral body by a pull-out driver 96 having male screw portions 96a screwed into the female screw holes 34k and 34k of the base end portions 33k and 33k, respectively, and taken out from the body together with the main body 11. Can do. Thereafter, the intervertebral body fixing device 10k can be re-fixed between the vertebral bodies after a treatment such as packing between the vertebral bodies with antibiotics or aggregates as necessary.
  • a blind plug (not shown, but not shown, male threaded portion 96a in FIG. 46) having a engaged portion such as a Phillips screwdriver groove or a hexagonal hole in the rear end portion is also usually provided in the female threaded hole 34k of the base end portion 33k of the pin 30k.
  • a screwdriver (not shown) provided with engaging portions at the distal end portions of the blind plugs to engage with the engaged portions prior to the pulling-out operation of the pins 30k and 30k. Can be removed from the female screw hole 34k and taken out of the body.
  • each member can be arbitrarily changed.
  • a plurality of pins 30, 30A to 30F, 30a to 30d, 30j, and 30k are arranged on one side of the vertebral bodies L1 and L2 in the extreme case, or two pairs such as substantially axisymmetric or asymmetrical.
  • the pins 30, 30A to 30F, 30a to 30d, 30j, and 30k are correspondingly thinner in the space accommodated in the female screw 16 of the main body 11, 11b to 11i as the quantity increases.
  • the outer surface engaging portion 14b of the main body 11 in the fifth embodiment can form the radial outer surface top portion of the spline teeth in a plurality of continuous sawtooth shapes.
  • the pair of arms 62 of the fixed reinforcing member 60 is not T-shaped in cross section, but at least the tip side is formed as a single plate, and one or more sharp pin-like protrusions are formed on the front surface of the plate. It is also possible to do.
  • the engaging grooves L1b and L2b are not provided in the front surface of the vertebral bodies L1 and L2 (fixed reinforcing tool engaging groove drilling It is also possible to press the tip of the arm 62 against the front surface of the vertebral bodies L1 and L2 and directly insert and fix the pin-like protrusions or sharp blades.
  • the shaft portion 81 can be a connection type that can be attached and detached in two in the longitudinal direction.
  • the front end engaging portion 93 of the pressing screw driver 90 is engaged with the rear end engaging portion 44 of the pressing screw 40, 50, 40 a, and the gripping portion 82 side shaft portion 81 is separated and shortened. It becomes easy to insert into the engaging portion 83 side shaft portion 81, and then the gripping portion 82 side shaft portion 81 can be reconnected, thereby improving operability.
  • interbody fusion devices 10, 10a to 10i, 10j, and 10k of the embodiments described above are inserted into the intervertebral disc space M between two adjacent vertebral bodies L1 and L2, and between the vertebral bodies L1 and L2.
  • the intervertebral body fixing device can be directly inserted into the intervertebral disc M, but is inserted between the vertebral bodies L1 and L2 after removing the intervertebral disc M that has been crushed and damaged by hernia or other defects or aging as necessary. May be.

Abstract

Disclosed are a surgical operation system for lumbar interbody fusion provided with a lumbar interbody fusion device which has a simple constitution and a small size, shows excellent handling properties, high reliability and high economical efficiency, enables the performance of a lumbar interbody fusion treatment within a short time and thus largely reduces the burden on a patient; and a device for keeping lumbar interbody space to be used in a surgical operation for lumbar interbody fusion. A surgical operation system for lumbar interbody fusion that is to be mounted in between lumbar bodies (L1, L2) adjacent to each other to fuse the lumbar interbody, comprising: a main body (11-11i), wherein outer surface-engagement parts (15, 14-14c) engaging to the opposing faces (L1a, L2a) of the lumbar bodies are formed on the outer surface of a substantially hollow cylindrical or tapered hollow conical board having a bottom at the front end and fitting for the lumbar interbody, and one or more guide holes (17-17d, 18-18d) penetrating along the lumbar body direction from the deep part of a female screw (16), which is provided in the hollow inner face (16a) in the back end side, to the outer surface while spreading out in the open-fan shape are formed; and a device (10-10k) for fixing the lumbar interbody which comprises one or more pins (30-30k) engageably placed in the guide holes and press screws (40-40k, 50) interconnecting with the female screw (16) and pressing the back end of the pins due to the thrust force thereof, and the front end side of which is guided along the guide holes due to the press screws pressing the back end of the pins so that the device is inserted into the lumbar bodies.

Description

椎体間固定外科手術システム及び椎体間固定外科手術用椎体間スペース保持装置Interbody fusion surgery system and interbody fusion space holding device for interbody fusion surgery
 本発明は、2つの隣接する椎体(椎骨)の間の適正な間隔に修正された椎間板スペースに椎体間固定装置を嵌入して椎体間を固定する椎体間固定外科手術に関し、特に、短時間で容易に椎体間固定処置を行うことにより患者の負担、手術侵襲を著しく軽減する信頼性の高い椎体間固定外科手術システム及び椎体間固定外科手術用椎体間スペース保持装置に関する。 The present invention relates to an interbody fusion surgery in which an interbody fusion device is inserted into an intervertebral disc space modified at an appropriate interval between two adjacent vertebral bodies (vertebrae) to fix the vertebral bodies. Highly reliable interbody fusion surgery system and interbody fusion space holding device for interbody fusion surgery that significantly reduce the burden on the patient and surgical invasion by performing the interbody fusion treatment easily in a short time About.
 近年増大する椎間板の辷り症やヘルニヤその他の欠陥あるいは老化などによる脊柱(脊椎)外科手術においては、損傷した椎間板に隣接する2つの椎体(椎骨)が適正な間隔に修正されて固定される。この多くの場合、環状体を除いて損傷した椎間板全体が切除され、脊柱に沿って伸びる神経に損傷を与えないように隣接する2つの椎体間の椎間板の空隙間すなわち椎間板スペースに何らかの支持体を配置する必要がある。 In recent years, in spinal surgery (vertebral spine) due to disc stiffness, herniation and other defects or aging, the two vertebral bodies (vertebrae) adjacent to the damaged intervertebral disc are corrected and fixed at appropriate intervals. In many cases, the entire injured disc is excised except for the annulus and some support in the disc space or disc space between two adjacent vertebral bodies so as not to damage the nerves extending along the spinal column Need to be placed.
 早期の技術において、前記2つの隣接する椎体の固定を促進するために骨材料が前記椎体間の支持体として充填されるとともに、損傷した前記椎体を安定的に連結固定するプレート又はロッドが用いられている。しかし、前記椎体が骨材料により固定されると、前記椎体の安定性を維持するために椎体に固定されたプレートやロッドなどの固定部材はもはや余分な邪魔ものとなる。さらに、これらのロッド又はプレートを移植固定する外科手術は、全身麻酔により脊柱の背後から行われ、脊柱の背後には筋肉や脊柱に沿って伸びる神経が複雑に錯綜し、これらの筋肉を剥がしたり、神経を損傷しないようにしたりする処置が煩わしく長時間を要する大手術で、手術侵襲が過大であった。 In early technology, plates or rods are filled with bone material as a support between the vertebral bodies to facilitate the fixation of the two adjacent vertebral bodies and stably connect and fix the damaged vertebral bodies Is used. However, when the vertebral body is fixed by bone material, a fixing member such as a plate or a rod fixed to the vertebral body to maintain the stability of the vertebral body is no longer an obstacle. In addition, the surgical procedure for implanting and fixing these rods or plates is performed from behind the spinal column by general anesthesia, and the muscles and nerves that extend along the spinal column are complicatedly complicated behind the spinal column, and these muscles can be peeled off. This is a major operation that takes a long time because it is troublesome to prevent the nerve from being damaged, and the surgical invasion is excessive.
 そこで近年、脊柱の背後から移植固定する前記ロッド又はプレートなどを用いず、背後側又は腹部側から損傷を受けた椎間板を切除し、完全な関節固定がなされるように、椎間板の空隙をなす隣接する椎体の間の安定性を維持するための移植部材すなわち椎体間固定装置を開発する多数の試みが特に欧米を中心になされている。 Therefore, in recent years, without using the rod or plate to be transplanted and fixed from behind the spinal column, the damaged intervertebral disc is excised from the back side or the abdominal side, and adjacent to the intervertebral disc space so that complete joint fixation is achieved. Numerous attempts have been made, especially in the West, to develop implants or interbody fusion devices to maintain stability between vertebral bodies.
 このような椎体間固定装置として最近提案されている代表的な次の2つの例がある。以下の説明において、生体(人体)内の機材又は椎体に対して背側方向の部分を「先端」又は「先端部」、腹側方向の部分を「後端」又は「後部」と呼ぶ。 There are two typical examples that have recently been proposed as such an interbody fusion device. In the following description, a portion in the dorsal direction with respect to the equipment or vertebral body in the living body (human body) is referred to as “tip” or “tip”, and a portion in the ventral direction is referred to as “rear end” or “rear”.
 図48は従来の第1例の椎体間固定装置の斜視図、図49は従来の第2例の椎体間固定装置が椎体間に固定された状態の縦断面図(主要部断面)である。 FIG. 48 is a perspective view of the conventional interbody fusion device of the first example, and FIG. 49 is a longitudinal sectional view (main part cross section) of the conventional interbody fusion device of the second example fixed between the vertebral bodies. It is.
 第1例の椎体間固定装置100は、図48に示すように、前端113が開口又は閉鎖面で後端112が開口した先細り中空円錐台形の外面に雄ねじ118及び119が形成されるとともに、平行な切頭形側壁122が形成された本体111からなり、図示しない隣接する椎体間に雄ねじ118、119を介して螺入される構成である。(特許文献1参照)。 As shown in FIG. 48, the interbody fusion device 100 of the first example has male threads 118 and 119 formed on the outer surface of a tapered hollow frustoconical shape with the front end 113 opened or closed and the rear end 112 opened, It consists of a main body 111 formed with parallel truncated side walls 122 and is screwed in between adjacent vertebral bodies (not shown) via male screws 118 and 119. (See Patent Document 1).
 第2例の椎体間固定装置は、図49に示すように、前端253が開口又は閉鎖面で後端256が一部開口した先細り中空円錐台形の外面に雄ねじ258及び259が形成されるとともに、平行な切頭形側壁262が形成された本体251と、後端256にそれぞれ隣接する上下の椎体L4、L5方向に末広がり状に傾斜して設けられた1対のねじ孔267、267に挿通され、椎体L4、L5内に傾斜して螺入する1対の骨ねじ280、280と、後端256の中心部に螺入して1対の骨ねじ280、280のヘッド281、283を共に押圧する止めねじ282とからなり、前記本体251が隣接する椎体L4、L5間に雄ねじ258、259を介して螺入された後に、1対の骨ねじ280、280が椎体L4、L5内に斜めに螺入する構成である。(特許文献2参照)。 In the interbody fusion device of the second example, as shown in FIG. 49, male threads 258 and 259 are formed on the outer surface of a tapered hollow frustoconical shape in which the front end 253 is open or closed and the rear end 256 is partially open. , And a pair of screw holes 267 and 267 provided so as to incline in a divergent shape toward the upper and lower vertebral bodies L4 and L5 adjacent to the rear end 256, respectively. A pair of bone screws 280, 280 that are inserted and tilted into the vertebral bodies L4, L5, and heads 281, 283 of the pair of bone screws 280, 280 that are screwed into the center of the rear end 256. And a pair of bone screws 280, 280 are inserted into the vertebral body L4, after the main body 251 is screwed between the adjacent vertebral bodies L4, L5 via male screws 258, 259. Screw into L5 diagonally It is formed. (See Patent Document 2).
 前記第1例及び第2例の椎体間固定装置は、いずれも本体111、251が隣接する上下の椎体間に挿入することができる小型サイズのものであることから、特に前記従来のロッド又はプレート等を移植固定する大掛かりな背後側からの外科手術に比べて腹部側から腹腔鏡を用いて比較的短時間で容易に椎体間に移植固定することができ、患者の負担、手術侵襲を大幅に軽減する効果が期待できるものである。 Since the interbody fusion devices of the first example and the second example are both of a small size that can be inserted between the upper and lower vertebral bodies to which the main bodies 111 and 251 are adjacent, particularly the conventional rod. Or it can be transplanted and fixed between vertebral bodies in a relatively short time using a laparoscope from the abdominal side compared with the large-scale surgical operation from the back side of transplanting and fixing plates, etc. Can be expected to significantly reduce.
 また、これらの椎体間固定装置を椎体間に移植固定する際に予め必要となる、2つの隣接する椎体(椎骨)間の適正な間隔を修正して椎間板スペースを保持するための椎体間スペース保持装置の最近提案されている代表的な次の例がある。 In addition, a vertebra for maintaining an intervertebral disc space by correcting an appropriate interval between two adjacent vertebral bodies (vertebrae) required in advance when implanting and fixing these interbody fusion devices between vertebral bodies. There is a typical example of the recently proposed interbody space holding device.
 図50は従来の代表的な椎体間スペース保持装置(腹側前弯症伸長外部スリーブ)の斜視図、図51は図50の椎体間スペース保持装置が椎体間に挿入された状態の側面図である。 FIG. 50 is a perspective view of a conventional typical interbody space holding device (ventral ventral lordosis extending external sleeve), and FIG. 51 is a side view of the interbody space holding device of FIG. 50 inserted between the vertebral bodies. FIG.
 従来の代表的な椎体間スペース保持装置(腹側前弯症伸長外部スリーブ)300は、図50、51に示すように、後端に筒状外部端330が設けられた長尺の中空管状部材302の先端310にいずれも連設され、隣接する椎体L6、L7の前面部にそれぞれ係合する複数の歯312、及び椎体L6、L7間の椎間板スペースの高さを回復するような高さを有するように180度の関係で対向し延長する一対の延長部320及び322が備えられた構成である。(特許文献3の図31、32等参照)。 As shown in FIGS. 50 and 51, a conventional typical interbody space holding device (ventral anterior lordosis extending outer sleeve) 300 is a long hollow tubular member provided with a cylindrical outer end 330 at the rear end. 302 is connected to the distal end 310 of 302, and a plurality of teeth 312 respectively engaged with front surfaces of adjacent vertebral bodies L6 and L7, and a height that restores the height of the disc space between the vertebral bodies L6 and L7. In this configuration, a pair of extension portions 320 and 322 are provided so as to face each other and extend at a 180-degree relationship. (See FIGS. 31 and 32 of Patent Document 3).
特開2007-75632号公報(優先権主張番号:US08/603,674)JP 2007-75632 A (priority claim number: US08 / 603, 674) 特表2002-501784号公報(優先権主張番号:US09/014,901)JP-T-2002-501784 (priority claim number: US09 / 014,901) 特開2004-267786号公報(優先権主張番号:US08/396,414)JP 2004-267786 A (priority claim number: US08 / 396,414)
 しかしながら、特許文献1(第1例)に記載の椎体間固定装置は、本体111が隣接する上下の椎体間に雄ねじ118、119を介して螺入されるだけの構成であることから、椎体間に挿入された後に椎体間の適正位置から後退あるいは回転して椎体間の適正間隔保持が崩れ易いという問題点がある。 However, the interbody fusion device described in Patent Document 1 (first example) is configured such that the main body 111 is simply screwed between the adjacent upper and lower vertebral bodies via male screws 118 and 119. After insertion between vertebral bodies, there is a problem that the proper spacing between the vertebral bodies tends to be lost by retreating or rotating from an appropriate position between the vertebral bodies.
 これに対して、特許文献2(第2例)に記載の椎体間固定装置は、本体251が隣接する椎体L4、L5間に雄ねじ258、259を介して螺入された後に、本体251の後端256に挿通された1対の骨ねじ280、280が椎体L4、L5内に斜めに螺入する構成であることから、前記特許文献1におけるような本体251の椎体間の適正位置からの後退や回転を防止することができるように改善されてはいる。しかし、後端256に隣接する上下の椎体L4、L5方向に末広がり状に傾斜して設けられたそれぞれ1対のねじ孔267、267、骨ねじ280、280及び1対の骨ねじ280、280の抜け止め用止めねじ282の構造並びにそれらの加工が煩雑であり、さらに、本体251及び止めねじ282とこれらの主軸に交叉する1対の骨ねじ280、280とのいわゆる3軸方向のねじ込み操作を腹腔鏡利用により狭隘な場所で行う必要があり、その操作性に劣るとともに腹腔鏡を用いて本体251、骨ねじ280、280及び止めねじ282をねじ込むための移植ドライバーの機構が複雑化し、コストも増大する等々の問題点がある。 In contrast, in the interbody fusion device described in Patent Document 2 (second example), the main body 251 is screwed between the adjacent vertebral bodies L4 and L5 via the male screws 258 and 259, and then the main body 251. Since the pair of bone screws 280 and 280 inserted through the rear end 256 is obliquely screwed into the vertebral bodies L4 and L5, the appropriateness between the vertebral bodies of the main body 251 as in Patent Document 1 is described. It has been improved to prevent retraction and rotation from position. However, a pair of screw holes 267, 267, a bone screw 280, 280, and a pair of bone screws 280, 280, which are provided so as to incline toward the upper and lower vertebral bodies L4, L5 adjacent to the rear end 256, respectively. The structure of the setscrew 282 for retaining the screw and the processing thereof are complicated, and further, a so-called triaxial screwing operation of the main body 251 and the setscrew 282 and a pair of bone screws 280, 280 intersecting with these main shafts. And the use of a laparoscope in a confined place, the operability is inferior and the mechanism of the transplant driver for screwing the main body 251, the bone screws 280 and 280 and the set screw 282 using the laparoscope becomes complicated, and the cost There are also problems such as an increase.
 また、特許文献3に記載の椎体間スペース保持装置(腹側前弯症伸長外部スリーブ)300は、人体腹部から隣接する椎体L6、L7の前面まで形成された内視鏡用腹腔部内のカニューレ(図示しない)内に先端から挿入して押し込むことにより中空管状部材302の先端310にそれぞれ設けられた一対の延長部320及び322を介して椎間板スペースの高さが回復されるとともに複数の歯312が椎体L6、L7の前面部に突刺して椎体L6、L7を固定するだけであることから、その後で前記椎体間固定装置を椎体L6、L7間に移植固定する際に比較的大きな外力が負荷される椎体L6、L7が複数の歯312との係合が離脱して後方又は左右の側方にずれ易いという欠点がある。 In addition, the interbody space holding device (ventricular lordosis extension external sleeve) 300 described in Patent Document 3 is a cannula in the abdominal part for endoscope formed from the human abdomen to the front surface of the adjacent vertebral bodies L6 and L7. By inserting and pushing in (not shown) from the distal end, the height of the disc space is restored and a plurality of teeth 312 is restored via a pair of extensions 320 and 322 provided at the distal end 310 of the hollow tubular member 302, respectively. Since the vertebral bodies L6 and L7 are merely pierced into the front portions of the vertebral bodies L6 and L7 to fix the vertebral bodies L6 and L7, the interbody fusion device is relatively fixed when transplanting and fixing the vertebral bodies L6 and L7. The vertebral bodies L6 and L7 to which a large external force is applied have a drawback in that the engagement with the plurality of teeth 312 is disengaged and the vertebral bodies L6 and L7 are liable to shift backward or left and right.
 そこで、本発明は、上記従来技術の問題点に鑑みてなされたものであり、本発明の目的は、簡潔な構成で、全体構造の単純化、小型化が図られ、操作性、信頼性及び経済性に優れ、短時間で容易に椎体間固定処置を行うことにより患者の負担、手術侵襲を著しく軽減する椎体間固定装置を具備する椎体間固定外科手術システム及びその外科手術に必要な信頼性を向上させた椎体間固定外科手術用椎体間スペース保持装置を提供することにある。 Therefore, the present invention has been made in view of the above-mentioned problems of the prior art, and an object of the present invention is to simplify and reduce the overall structure with a simple configuration, and to improve operability, reliability and Necessary for interbody fusion surgery system with an interbody fusion device that is highly economical and easily reduces the burden on the patient and surgical invasion by performing the interbody fusion treatment easily in a short time. It is an object of the present invention to provide an interbody space holding device for interbody fusion surgery with improved reliability.
 上記目的を達成するため、請求項1の発明の椎体間固定外科手術システムは、2つの隣接する椎体(椎骨)間の適正な間隔を保持するように形成された前端有底の略中空円筒又は先細り中空円錐台の外面に前記2つの椎体の対向面部に係合する外面係合部が形成されるとともに、後端側の中空内面に適宜深さの雌ねじが形成され、さらに該雌ねじの先端中空内面から前記椎体の対向面に向かって径方向に末広がりに傾斜し外面まで貫通する1つ又は複数の屈曲状又はストレート状のガイド孔が穿設された本体と、前記ガイド孔内に遊嵌収容され、先端側が前記各ガイド孔に沿って挿通された屈曲状又はストレート状の1本又は複数のピンと、前記本体の雌ねじに螺合しその軸方向推進力により、前記ピンの後端を押圧する押圧ねじとを備え、前記本体が前記椎体間の椎間板スペースに外面係合部を介して嵌入され固定された後に、前記ピンが前記本体の雌ねじに螺合された押圧ねじの軸方向推進力により後端を押圧されて先端側がガイド孔に沿って順次案内され前記椎体内に差込まれる椎体間固定装置を具備することを特徴とする。 In order to achieve the above object, the interbody fusion surgical system according to the first aspect of the present invention is a generally hollow body with a front end that is formed so as to maintain an appropriate distance between two adjacent vertebral bodies (vertebrae). An outer surface engaging portion that engages with the opposing surface portions of the two vertebral bodies is formed on the outer surface of the cylindrical or tapered hollow truncated cone, and a female screw of an appropriate depth is formed on the hollow inner surface on the rear end side. A main body in which one or a plurality of bent or straight guide holes are formed so as to incline in the radial direction from the hollow inner surface of the distal end toward the opposing surface of the vertebral body and penetrate to the outer surface; One or a plurality of bent or straight pins inserted into the guide holes along the guide holes and screwed into the female screw of the main body, and the axial propulsive force of the rear ends of the pins. A pressing screw for pressing the end After the main body is inserted and fixed in the intervertebral disc space via the outer surface engaging portion, the rear end is pressed by the axial thrust of the pressing screw screwed into the female screw of the main body. And an intervertebral body fixing device in which the distal end side is sequentially guided along the guide hole and inserted into the vertebral body.
 請求項2の発明は、請求項1記載の椎体間固定外科手術システムであって、前記略中空円筒形本体の中央部外径が僅かに太めの太鼓状に形成されていることを特徴とする。 The invention according to claim 2 is the interbody fusion surgical system according to claim 1, characterized in that the outer diameter of the central part of the substantially hollow cylindrical body is formed in a slightly thick drum shape. To do.
 請求項3の発明は、請求項1記載の椎体間固定外科手術システムであって、前記ピンは、丸や多角形を含む任意断面形状の中実又は中空の棒状体もしくは少なくとも先端側又は全長に亘り複数の薄板材又は丸や各種扁平型を含む任意断面形を有する線材が積層されて一体的な丸や多角形を含む任意断面形状の棒状積層体からなり、その先端部が尖鋭状に形成されていることを特徴とする。 A third aspect of the present invention is the interbody fusion surgical system according to the first aspect, wherein the pin is a solid or hollow rod-shaped body having an arbitrary cross-sectional shape including a circle or a polygon, or at least the distal end side or the entire length. It consists of a rod-shaped laminated body with an arbitrary cross-sectional shape including a round or polygonal shape laminated with a plurality of thin plate materials or a wire having an arbitrary cross-sectional shape including circles and various flat shapes, and the tip thereof is sharp It is formed.
 請求項4の発明は、請求項1乃至請求項3のいずれか1項記載の椎体間固定外科手術システムであって、前記1本又は複数のピンは、後端に雌ねじ穴が設けられた基端部が個別又は一体的に形成され連設されており、前記押圧ねじは前記本体内への螺合方向とは逆方向の回転操作により前記本体内から、前記本体は前記椎体間への嵌入方向とは逆方向への回転及び/又は引抜き操作により椎体間からそれぞれ取外され体外に取出し可能であって、前記ピンが椎体内に差込まれた後で、前記押圧ねじが前記本体から引抜かれるとともに、前記ピンが基端部の雌ねじ穴に螺合する雄ねじ部を先端部に備えた引抜きドライバーにより前記椎体間から引抜かれ、前記本体と共に体外に取出されるように構成されていることを特徴とする。 The invention according to claim 4 is the interbody fusion surgical system according to any one of claims 1 to 3, wherein the one or more pins are provided with a female screw hole at a rear end. Proximal end portions are individually or integrally formed and continuously provided, and the pressing screw is rotated from within the main body by a rotation operation in a direction opposite to the screwing direction into the main body, and the main body is moved between the vertebral bodies. Can be removed from between the vertebral bodies by being rotated in the direction opposite to the insertion direction and / or withdrawing operation, and removed from the body. After the pin is inserted into the vertebral body, The pin is pulled out from the main body, and the pin is pulled out from between the vertebral bodies by a pull-out driver having a male threaded portion that engages with a female threaded hole at the base end, and is taken out of the body together with the main body. It is characterized by being.
 請求項5の発明は、請求項4記載の椎体間固定外科手術システムであって、前記ピン基端部の雌ねじ穴内には、通常、後端部に被係合部を有する盲プラグが挿嵌されており、前記ピンの引抜き操作に先立ち、前記盲プラグが前記被係合部に係合する係合部を先端部に備えたドライバーにより前記雌ねじ穴内から取外され体外に取出し可能であることを特徴とする。 A fifth aspect of the present invention is the interbody fusion surgical system according to the fourth aspect, wherein a blind plug having an engaged portion at the rear end is normally inserted into the female screw hole of the pin base end. Prior to the pulling-out operation of the pin, the blind plug can be removed from the female screw hole and taken out of the body by a screwdriver having an engaging portion that engages the engaged portion at the tip. It is characterized by that.
 請求項6の発明は、請求項1記載の椎体間固定外科手術システムであって、前記外面係合部は、雄ねじ状に形成されていることを特徴とする。 A sixth aspect of the invention is the interbody fusion surgical system according to the first aspect, wherein the outer surface engaging portion is formed in a male screw shape.
 請求項7の発明は、請求項1記載の椎体間固定外科手術システムであって、前記外面係合部は、前記主軸に平行な複数のスプライン歯状に形成されていることを特徴とする。 The invention according to claim 7 is the interbody fusion surgical system according to claim 1, wherein the outer surface engaging portion is formed in a plurality of spline teeth parallel to the main axis. .
 請求項8の発明は、請求項1記載の椎体間固定外科手術システムであって、前記外面係合部は、前記主軸に平行な複数の鋸歯状に形成されていることを特徴とする。 The invention according to claim 8 is the interbody fusion surgical system according to claim 1, wherein the outer surface engaging portion is formed in a plurality of sawtooth shapes parallel to the main axis.
 請求項9の発明は、請求項1、請求項6乃至請求項8のいずれか1項記載の椎体間固定外科手術システムであって、前記外面係合部の軸方向先端及び径方向外面頭頂部が尖鋭刃状に形成されていることを特徴とする。 The invention according to claim 9 is the interbody fusion surgical system according to any one of claims 1, 6 to 8, wherein the distal end in the axial direction and the outer radial head of the outer surface engaging portion are provided. The top is formed in the shape of a sharp blade.
 請求項10の発明は、請求項1乃至請求項9のいずれか1項記載の椎体間固定外科手術システムであって、前記本体には、外面の上下・左右にそれぞれ連通する血管新生用開口部及び骨内部成長用開口部が複数設けられていることを特徴とする。 A tenth aspect of the invention is the interbody fusion surgical system according to any one of the first to ninth aspects, wherein the main body has an angiogenesis opening communicating with the upper, lower, left, and right sides of the outer surface. And a plurality of openings for bone ingrowth.
 請求項11の発明は、請求項1乃至請求項10のいずれか1項記載の椎体間固定外科手術システムであって、前記押圧ねじの後端に前記本体の後端面の全面又は一部を覆うキャップが形成されていることを特徴とする。 The invention of claim 11 is the interbody fusion surgical system according to any one of claims 1 to 10, wherein the whole or part of the rear end surface of the main body is attached to the rear end of the pressing screw. A covering cap is formed.
 請求項12の発明は、請求項11記載の椎体間固定外科手術システムであって、前記押圧ねじに遊嵌されるボスと、該ボスの外面に軸対称に立設され、前記押圧ねじのキャップ部にボス部後端面が押圧されて先端部が前記隣接する椎体の腹部側前面にそれぞれ係合固定される1対のアームと、からなる固定補強具をさらに備えることを特徴とする。 The invention according to claim 12 is the interbody fusion surgical system according to claim 11, wherein the boss is loosely fitted to the pressing screw, and is erected on the outer surface of the boss so as to be axially symmetrical. It further comprises a fixing reinforcing tool comprising a pair of arms whose rear end surface is pressed against the cap portion and whose front end portion is engaged and fixed to the abdomen front surface of the adjacent vertebral body.
 請求項13の発明は、請求項1乃至請求項12のいずれか1項記載の椎体間固定外科手術システムであって、前記本体の雌ねじ内に遊嵌収容され、前記ピンの後端部に当接配置される摩擦板をさらに備えることを特徴とする。 A thirteenth aspect of the invention is the interbody fusion surgical system according to any one of the first to twelfth aspects, wherein the interbody fusion surgical system is loosely accommodated in the female screw of the main body, and is attached to the rear end portion of the pin. It is further characterized by further including a friction plate disposed in contact therewith.
 請求項14の発明は、請求項13記載の椎体間固定外科手術システムであって、前記ピンの後端部が、少なくとも左右方向への移動が拘束されるように前記摩擦板に係合又は固定されていることを特徴とする。 The invention according to claim 14 is the interbody fusion surgical system according to claim 13, wherein the rear end portion of the pin is engaged with the friction plate so as to be restrained from moving at least in the left-right direction. It is fixed.
 請求項15の発明は、請求項1乃至請求項14のいずれか1項記載の椎体間固定外科手術システムであって、前記椎体間固定装置は、腹部側から腹腔鏡を併用した椎体間固定外科手術により前記椎体間に固定されることを特徴とする。 The invention of claim 15 is the interbody fusion surgery system according to any one of claims 1 to 14, wherein the interbody fusion device is a vertebral body using a laparoscope in combination from the abdominal side. It is fixed between the vertebral bodies by interstitial surgery.
 請求項16の発明は、請求項1乃至請求項15のいずれか1項記載の椎体間固定外科手術システムであって、後端に把持部が設けられた中空長尺のシャフト部の先端に前記椎体間固定装置の本体の後端部に形成された後端係合部に係合する先端係合部を有し、該先端係合部を前記本体の後端係合部に係合した状態で、生体腹部から前記椎体の前面まで形成された内視鏡用腹腔部内のカニューレ内に挿入されて前記2つの隣接する椎体間の適正な間隔を保持する椎体間スペース保持装置の中空部内に挿入され、前記本体を押圧又は/及び回転することにより前記椎体間に嵌入させる本体嵌入ドライバーを備えることを特徴とする。 A sixteenth aspect of the present invention is the interbody fusion surgical system according to any one of the first to fifteenth aspects, wherein the distal end of a hollow long shaft portion having a grip portion at the rear end is provided. A front end engaging portion that engages with a rear end engaging portion formed at a rear end portion of the main body of the interbody fusion device, and the front end engaging portion is engaged with the rear end engaging portion of the main body; In this state, the interbody space holding device is inserted into a cannula in the abdominal cavity for endoscope formed from the living body abdomen to the front surface of the vertebral body to maintain an appropriate distance between the two adjacent vertebral bodies. And a main body insertion driver for inserting the main body between the vertebral bodies by pressing or / and rotating the main body.
 請求項17の発明は、請求項16記載の椎体間固定外科手術システムであって、前記本体嵌入ドライバーは、先端係合部が金属製で、シャフト部は高分子材料からなることを特徴とする。 The invention according to claim 17 is the interbody fusion surgery system according to claim 16, wherein the main body insertion driver has a tip engaging portion made of metal and a shaft portion made of a polymer material. To do.
 請求項18の発明は、請求項16又は請求項17記載の椎体間固定外科手術システムであって、後端に把持部が設けられた長尺のシャフト部の先端に前記椎体間固定装置の押圧ねじの後端部に形成された後端係合部に係合する先端係合部を有し、該先端係合部を前記押圧ねじの後端係合部に係合した状態で前記本体嵌入ドライバーの中空部内に挿入し、前記押圧ねじを前記椎間板スペースに固定された前記椎体間固定装置の本体の雌ねじ部に挿入して押圧しながら回転することにより前記雌ねじに螺合させその軸方向推進力により前記ピンの先端側をガイド孔に沿って順次案内させて前記椎体内に差込む押圧ねじドライバーをさらに備えることを特徴とする。 The invention of claim 18 is the interbody fusion surgery system according to claim 16 or claim 17, wherein the interbody fusion device is attached to the distal end of a long shaft portion provided with a grip portion at the rear end. A front end engaging portion that engages with a rear end engaging portion formed at a rear end portion of the pressing screw, and the front end engaging portion is engaged with the rear end engaging portion of the pressing screw in the state where the front end engaging portion is engaged. Inserted into the hollow part of the body-inserting driver, inserted into the female screw part of the main body of the interbody fusion device fixed to the intervertebral disc space and rotated while being pressed to be screwed into the female screw, and It is further characterized by further comprising a pressing screw driver that sequentially guides the distal end side of the pin along the guide hole by an axial driving force and inserts the pin into the vertebral body.
 請求項19の発明は、請求項18記載の椎体間固定外科手術システムであって、前記押圧ねじドライバーは、先端係合部が金属製で、シャフト部は高分子材料からなることを特徴とする。 The invention according to claim 19 is the interbody fusion surgical system according to claim 18, wherein the pressing screw driver has a tip engaging portion made of metal and a shaft portion made of a polymer material. To do.
 請求項20の発明の椎体間固定外科手術用椎体間スペース保持装置は、生体の椎体間固定外科手術の際に、2つの隣接する椎体(椎骨)間の適正な間隔を修正して椎間板スペースを保持するための装置であって、後端に把持部が設けられ、生体腹部側に設けられた内視鏡用腹腔部内のカニューレを介して前記椎体の前面近傍まで挿入される中空長尺の第1のシャフト部と、該第1のシャフト部の先端部に軸方向に沿って延設され、前記隣接する椎体の左右両側面をそれぞれ挟持し固定する固定爪が先端に連接されて前記椎体の直交面内で開閉可能な少なくとも各1対のクランプアームと、を有する椎体クランプ機構を備えることを特徴とする。 The interbody space holding device for interbody fusion surgery according to the invention of claim 20 corrects an appropriate interval between two adjacent vertebral bodies (vertebrae) during a body interbody fusion surgery. A device for holding the intervertebral disc space, having a gripping portion at the rear end and being inserted to the vicinity of the front surface of the vertebral body via a cannula in the abdominal portion for endoscope provided on the living body abdominal portion side A hollow long first shaft portion and a fixing claw extending in the axial direction at the distal end portion of the first shaft portion and holding and fixing the left and right side surfaces of the adjacent vertebral bodies at the distal end And a vertebral body clamping mechanism having at least one pair of clamp arms connected to each other and capable of opening and closing in an orthogonal plane of the vertebral body.
 請求項21の発明は、請求項20記載の椎体間固定外科手術用椎体間スペース保持装置であって、前記椎体クランプ機構は、先端に前記各固定爪が連設され、後端部が前記第1のシャフト部の先端部に連設され、フリー状態では前記固定爪をそれぞれ前記椎体の直交面内で拡径して開くように屈曲されて弾支する弾性支持部を有する各1対のクランプアームと、前記第1のシャフト部に前進/後退自在に外嵌され、後端に把持部が設けられた中空長尺の第2のシャフト部の先端部が前進して前記弾性支持部を外側から押圧することにより前記各1対のクランプアームを縮径方向に閉じ、その先端部が前記弾性支持部から後退することにより前記各1対のクランプアームを拡径方向に開くクランプアーム開閉管と、を備えることを特徴とする。 The invention of claim 21 is the interbody space holding device for interbody fusion surgery according to claim 20, wherein the vertebral body clamp mechanism has each of the fixing claws connected to the tip, and the rear end Each having an elastic support portion that is elastically supported by being bent so as to open and expand the fixed claw in the orthogonal plane of the vertebral body in a free state. A pair of clamp arms and a front end portion of a hollow long second shaft portion which is externally fitted to the first shaft portion so as to be movable forward / backward, and provided with a gripping portion at the rear end are advanced to the elasticity. Clamps that open the pair of clamp arms in the diameter increasing direction by closing the pair of clamp arms in the diameter reducing direction by pressing the support parts from the outside and retreating the tip parts from the elastic support parts. An arm opening and closing tube.
 請求項22の発明は、請求項20記載の椎体間固定外科手術用椎体間スペース保持装置であって、前記椎体クランプ機構は、先端に前記各固定爪が連設され、後端部が前記第1のシャフト部の先端部に第1の支持軸を介して前記椎体の直交面内で揺動自在に枢着された各1対のクランプアームと、前記第1のシャフト部に前進/後退自在に外嵌され、後端に把持部が設けられた中空長尺の第2のシャフト部と、前記各1対のクランプアームの中間部に第2の支持軸を介してそれぞれ一端部が揺動自在に枢着されるとともに、その各他端部が前記第2のシャフト部の先端部に第3の支持軸を介して揺動自在に枢着された各1対のリンク部材と、からなり、前記第2のシャフト部が前進又は後退することにより前記各1対のリンク部材を前記第3の支持軸を支点として反時計回り又は時計回りに揺動させて前記各1対のクランプアームを前記椎体の直交面内で前記第1の支持軸を支点として縮径方向に閉じ又は拡径方向に開くトグル機構を構成することを特徴とする。 The invention of claim 22 is the interbody space holding device for interbody fusion surgery according to claim 20, wherein the vertebral body clamping mechanism has the respective fixing claws connected to the tip, and the rear end portion. A pair of clamp arms pivotally attached to the distal end portion of the first shaft portion via a first support shaft in an orthogonal plane of the vertebral body, and the first shaft portion A hollow long second shaft portion that is externally fitted so as to be able to move forward / backward and a grip portion is provided at the rear end, and an intermediate portion of each of the pair of clamp arms via a second support shaft. Each pair of link members is pivotably attached to each other, and each other end thereof is pivotally attached to the tip of the second shaft portion via a third support shaft. And each of the pair of link members is moved in the first shaft by the second shaft portion moving forward or backward. The pair of clamp arms are closed or expanded in the diameter-reducing direction with the first support shaft as a fulcrum within the orthogonal plane of the vertebral body by swinging counterclockwise or clockwise around the support shaft as a fulcrum. A toggle mechanism that opens in a direction is configured.
 請求項23の発明は、請求項20乃至請求項22のいずれか1項記載の椎体間固定外科手術用椎体間スペース保持装置であって、前記固定爪の椎体挟持面に前記椎体の側面に突刺可能な複数の尖鋭突起を有することを特徴とする。 The invention of claim 23 is the interbody space holding device for interbody fusion surgery according to any one of claims 20 to 22, wherein the vertebral body is provided on the vertebral body clamping surface of the fixation claw. It has a plurality of sharp protrusions that can be pierced on the side surface.
 請求項24の発明の椎体間固定外科手術用椎体間スペース保持装置は、生体の椎体間固定外科手術の際に、2つの隣接する椎体(椎骨)間の適正な間隔を修正して椎間板スペースを保持するための装置であって、後端に把持部が設けられ、生体腹部側に設けられた内視鏡用腹腔部内のカニューレを介して前記椎体の前面近傍まで挿入される中空長尺の第1のシャフト部と、該第1のシャフト部の外面に軸方向に沿って回転自在に延設され、先端に形成されたねじ部が前記隣接する椎体の一方又は両方の前面部に羅入し固定される長尺固定ねじ部材と、前記第1のシャフト部の先端部に突設され、前記隣接する椎体の一方又は両方の前面部に突刺可能な一つ又は複数の針状突起と、を備えることを特徴とする。 The interbody space holding device for interbody fusion surgery according to the invention of claim 24 corrects an appropriate distance between two adjacent vertebral bodies (vertebrae) during a body interbody fusion surgery. A device for holding the intervertebral disc space, having a gripping portion at the rear end and being inserted to the vicinity of the front surface of the vertebral body via a cannula in the abdominal portion for endoscope provided on the living body abdominal portion side A hollow elongate first shaft portion and a threaded portion that extends in the axial direction on the outer surface of the first shaft portion so as to be rotatable in the axial direction, are formed on one or both of the adjacent vertebral bodies. A long fixing screw member that is inserted into and fixed to the front surface portion, and one or a plurality that can project into the front surface portion of one or both of the adjacent vertebral bodies protruding from the distal end portion of the first shaft portion A needle-like protrusion.
 請求項25の発明は、請求項20乃至請求項24のいずれか1項記載の椎体間固定外科手術用椎体間スペース保持装置であって、前記第1のシャフト部の先端部に前記椎体の外径より僅かに狭い間隔で前記椎体間スペースに向かい軸方向に沿って対向状態で延設され、先端部から前記椎間板スペース内に挿入されることにより前記隣接する椎体を適正な間隔に修正して保持するような外形形状に形成された少なくとも1対のスペーサーをさらに備えることを特徴とする。 A twenty-fifth aspect of the invention is the interbody space holding device for interbody fusion surgery according to any one of the twenty-second to twenty-fourth aspects, wherein the vertebra is provided at a distal end portion of the first shaft portion. The adjacent vertebral bodies are properly connected to each other by extending into the intervertebral space at an interval slightly narrower than the outer diameter of the body and facing the intervertebral space in the axial direction. It is further characterized by further comprising at least one pair of spacers formed in an outer shape so as to be corrected and held at intervals.
 請求項1の発明によれば、椎体間固定装置が隣接する椎体間の適正な間隔に適合する外形を有する小型であり、本体を椎体間に嵌入し固定した後に押圧ねじを本体の雌ねじにねじ込むだけで押圧されたピンの先端側がガイド孔に沿って案内され椎体内に差込まれて固定される簡潔な構成であることから、腹腔鏡を利用して全て本体主軸方向からの一軸による押圧又は/及びねじ込み操作のみで容易に短時間で椎体間固定処置を行うことができる。これにより、従来の椎体間固定外科手術に比べて手術規模が大幅に縮小化されるとともに手術時間及び回復期間とも大幅に短縮できるため、患者や医者を含む医療スタッフの肉体及び精神的負担、患者の手術侵襲さらには経済的負担を著しく軽減することができる。 According to the first aspect of the present invention, the interbody fusion device is a small size having an outer shape adapted to an appropriate distance between adjacent vertebral bodies, and after the main body is inserted and fixed between the vertebral bodies, the pressing screw is attached to the main body. Since the tip side of the pin that is pressed just by screwing into the female screw is guided along the guide hole and is inserted into the vertebral body and fixed, all from the main axis direction using the laparoscope The interbody fusion treatment can be easily performed in a short time by only pressing or / and screwing by one axis. As a result, the operation scale can be greatly reduced as compared to conventional interbody fusion surgery, and the operation time and recovery period can be greatly reduced, so that the physical and mental burden of medical staff including patients and doctors, The surgical invasion and even the economic burden on the patient can be significantly reduced.
 これに加えて、椎体内に差込まれ固定されたピンにより椎体間固定装置本体の椎体間の適正位置からの後退や回転を防止することができ、椎体間固定の信頼性が確保されるとともに、椎体間固定構造及び全て本体主軸方向の一軸による押圧又は/及びねじ込みだけの操作が上記の如く大幅に簡潔化及びコンパクト化され、操作性及び経済性とも一層優れた椎体間固定装置を具備した椎体間固定外科手術システムを提供することができる等々の効果がある。 In addition, the pin inserted and fixed in the vertebral body can prevent the intervertebral body fixing device body from retreating or rotating from the appropriate position between the vertebral bodies. The vertebral body is secured, and the interbody fixing structure and the operation of only pressing or / and screwing by one axis in the main body axis direction are greatly simplified and compacted as described above, and the operability and economy are further excellent. It is possible to provide an interbody fusion surgical system having an interbody fusion device, and so on.
 請求項2の発明によれば、請求項1の発明と同様な効果を有するのに加えて、略中空円筒形本体の中央部外径が僅かに太めの太鼓状に形成されているため、椎体間にしっかり固定される効果がある。 According to the invention of claim 2, in addition to having the same effect as that of the invention of claim 1, the outer diameter of the central part of the substantially hollow cylindrical main body is formed in a slightly thick drum shape. There is an effect that is firmly fixed between the bodies.
 請求項3の発明によれば、請求項1の発明と同様な効果を有するのに加えて、ピンの先端部が尖鋭に形成されているため、椎体内部にピンを容易に差込み易くする。また、中空の棒状体あるいは棒状積層体からなるピンは、比較的容易に屈曲など変形し易く先端部側が本体のガイド孔に沿ってスムースに案内される操作性が向上するとともに、特に棒状積層体からなるピンは任意の形状に形成することが容易で設計の自由度が向上する等々の効果がある。 According to the invention of claim 3, in addition to having the same effect as that of the invention of claim 1, since the tip of the pin is formed sharply, the pin can be easily inserted into the vertebral body. Further, a pin made of a hollow rod-like body or a rod-like laminated body is relatively easy to bend and deform, and the tip side is smoothly guided along the guide hole of the main body. Such a pin can be easily formed into an arbitrary shape, and the design flexibility is improved.
 請求項4の発明によれば、請求項1乃至請求項3のいずれか1項の発明と同様な効果を有するのに加えて、ピンを介して椎体間に椎体間固定装置が固定された後で万一感染症などによる不慮の化膿障害が発生した場合に、ピンを基端部の雌ねじ穴に螺合する引抜きドライバーにより椎体間から引抜いて本体と共に体外に取出し、椎体間に抗生剤や必要に応じて骨材等を詰める等の処置を施してから再度椎体間固定装置を椎体間に固定し直すことができる効果がある。 According to the invention of claim 4, in addition to having the same effect as the invention of any one of claims 1 to 3, the interbody fusion device is fixed between the vertebral bodies via the pins. In the unlikely event that an unexpected suppuration disorder occurs due to infection, etc., the pin is pulled out from between the vertebral bodies by a pulling screwdriver that is screwed into the female screw hole at the proximal end, and is taken out of the body together with the main body. There is an effect that the interbody fusion device can be re-fixed between the vertebral bodies again after a treatment such as filling with an antibiotic or an aggregate if necessary.
 請求項5の発明によれば、請求項4の発明と同様な効果を有するのに加えて、ピン基端部の雌ねじ穴内に取出し可能に挿嵌された盲プラグにより雌ねじ穴内に椎体間内髄液や骨形成材料等の異物の侵入を防止することから、ピンの引抜き操作に先立ち前記盲プラグを雌ねじ穴内から取外してピン基端部の雌ねじ穴に引抜きドライバーを容易に素早くねじ込み易くすることができるので椎体間固定装置取外しの操作性を向上させる効果がある。 According to the invention of claim 5, in addition to having the same effect as that of the invention of claim 4, the intervertebral body is inserted into the female screw hole by the blind plug that is removably inserted into the female screw hole of the pin base end portion. To prevent intrusion of foreign matter such as cerebrospinal fluid and bone forming material, remove the blind plug from the female screw hole before pulling out the pin, and make it easy to quickly and easily screw the extraction screwdriver into the female screw hole at the base end of the pin. Therefore, the operability of removing the interbody fusion device can be improved.
 請求項6の発明によれば、請求項1の発明と同様な効果を有するのに加えて、外面係合部が雄ねじ状に形成されているため、本体を椎体間に容易にねじ込み固定することができる効果がある。 According to the invention of claim 6, in addition to having the same effect as that of the invention of claim 1, since the outer surface engaging portion is formed in a male screw shape, the main body can be easily screwed and fixed between the vertebral bodies. There is an effect that can.
 請求項7の発明によれば、請求項1の発明と同様な効果を有するのに加えて、外面係合部が前記主軸に平行な複数のスプライン歯状に形成されているため、本体を押圧するだけで短時間に椎体間に嵌入し固定することができ、操作性が向上する効果がある。 According to the invention of claim 7, in addition to having the same effect as that of the invention of claim 1, the outer surface engaging portion is formed in a plurality of spline teeth parallel to the main shaft, so that the main body is pressed. It is possible to insert and fix between vertebral bodies in a short time just by doing so, and there is an effect of improving operability.
 請求項8の発明によれば、請求項1の発明と同様な効果を有するのに加えて、外面係合部が前記主軸に平行な複数の鋸歯状に形成されているため、本体を押圧するだけで短時間に椎体間に容易に嵌入して抜け止めによる固定の信頼性が確保できる効果がある。 According to the invention of claim 8, in addition to having the same effect as that of the invention of claim 1, the outer surface engaging portion is formed in a plurality of sawtooth shapes parallel to the main shaft, so that the main body is pressed. It has the effect of being able to easily fit between vertebral bodies in a short time and to secure the fixing reliability by retaining.
 請求項9の発明によれば、請求項1、請求項6乃至請求項8のいずれか1項の発明と同様な効果を有するのに加えて、外面係合部の軸方向先端及び径方向外面頭頂部が尖鋭刃状に形成されているため、椎体間への本体の嵌入が一層容易化する効果がある。 According to the invention of claim 9, in addition to having the same effects as those of the invention of any one of claims 1, 6 to 8, the axial front end and the radial outer surface of the outer surface engaging portion Since the top of the head is formed in a sharp blade shape, there is an effect of facilitating the insertion of the main body between the vertebral bodies.
 請求項10の発明によれば、請求項1乃至請求項9のいずれか1項の発明と同様な効果を有するのに加えて、本体外面の上下・左右に複数の血管新生用開口部及び骨内部成長用開口部が設けられていることから、これらの開口部は椎体を囲繞する高度に血管化された組織に接触して血管新生を促進する通路となるとともに、隣接する椎体対向面部からの出血が骨内部組織成長を容易にする通路となって椎体間固定を促進する効果がある。このように、椎体間が一旦固定されると、椎体間固定装置自体が骨塊の一種の固定体となる。 According to the invention of claim 10, in addition to having the same effect as that of any one of claims 1 to 9, a plurality of angiogenesis openings and bones are provided on the upper, lower, left and right sides of the outer surface of the main body. Due to the presence of ingrowth openings, these openings contact the highly vascularized tissue surrounding the vertebral body to provide a path for promoting angiogenesis and adjacent vertebral body facing surfaces The bleeding from the vertebrae serves as a passage for facilitating bone internal tissue growth and has an effect of promoting interbody fusion. As described above, once the intervertebral body is fixed, the interbody fixing device itself becomes a kind of fixed body of the bone mass.
 請求項11の発明によれば、請求項1乃至請求項10のいずれか1項の発明と同様な効果を有するのに加えて、押圧ねじの後端に形成されたキャップが本体の後端の全面又は一部を覆うことにより、固定を促進する骨形態発生タンパク質を液体担体内に含有し本体中空内部に充填される骨形成材料等の流出を防止する効果がある。また、キャップは、最終的に本体の後端面又は椎体の前面部に当接することにより、本体内部への押圧ねじのねじ込み代を規定するとともに押圧ねじの逆回転摩擦力がアップするため押圧ねじの逆回転防止効果及びこれによるピンの抜け止め効果をも有する。 According to the invention of claim 11, in addition to having the same effect as the invention of any one of claims 1 to 10, the cap formed at the rear end of the pressing screw is provided at the rear end of the main body. By covering the entire surface or a part thereof, there is an effect of preventing the outflow of the bone-forming material or the like that contains the bone morphogenic protein that promotes fixation in the liquid carrier and is filled in the hollow body. In addition, since the cap finally comes into contact with the rear end surface of the main body or the front surface of the vertebral body, the screw screw is allowed to be screwed into the main body, and the reverse rotational frictional force of the press screw is increased. This also has the effect of preventing the reverse rotation of the pin and preventing the pin from coming off.
 請求項12の発明によれば、請求項11の発明と同様な効果を有するのに加えて、押圧ねじに遊嵌された固定補強具の1対のアーム先端部が押圧ねじのキャップ部にボス部後端面が押圧されることにより隣接する椎体の前面部にそれぞれ係合し固定されるため、椎体間固定が強固に補強されるとともに、アームの剛性反力により押圧ねじの逆回転摩擦力がアップするため押圧ねじの逆回転防止効果及びこれによるピンの抜け止め効果を一層向上させることができる。 According to the invention of claim 12, in addition to having the same effect as that of the invention of claim 11, a pair of arm tip portions of the fixing reinforcement loosely fitted to the press screw are bosses on the cap portion of the press screw. When the rear end surface of each part is pressed and engaged with the front part of the adjacent vertebral body, the interbody fixation is strongly reinforced, and the reverse rotation friction of the pressing screw is caused by the arm's rigid reaction force. Since the force increases, the effect of preventing the reverse rotation of the pressing screw and the effect of preventing the pin from coming off can be further improved.
 請求項13の発明によれば、請求項1乃至請求項12のいずれか1項の発明と同様な効果を有するのに加えて、押圧ねじのピン後端部押圧が摩擦板を介して行われることから、押圧ねじとピン後端面側との摩擦力が減少するとともにピン後端面が直接押圧ねじの回転力を受けないためピン後端部が本体雌ねじ部内面との隙間の多い左右方向に押し遣られようとする力を殆ど受けることなく、押圧ねじも小トルクでねじ込まれるとともにピンがスムースに前方に押し込まれることが可能になる効果がある。 According to the invention of claim 13, in addition to having the same effect as the invention of any one of claims 1 to 12, the pin rear end pressing of the pressing screw is performed via the friction plate. Therefore, the frictional force between the pressing screw and the pin rear end surface is reduced and the pin rear end surface is not directly subjected to the rotational force of the pressing screw. There is an effect that the pressing screw can be screwed with a small torque and the pin can be smoothly pushed forward without almost receiving the force to be sent.
 請求項14の発明によれば、請求項13の発明と同様な効果を有するのに加えて、ピンの後端部が少なくとも左右方向への移動が拘束されるように摩擦板に係合又は固定されているため、特にピン後端部が本体雌ねじ部内面との隙間の多い左右方向に押し遣られようとする力を殆ど受けることなく、押圧ねじも小トルクで雌ねじ内にねじ込まれるとともにピンがスムースに押し込まれることができる信頼性の向上効果がある。 According to the fourteenth aspect of the invention, in addition to having the same effect as the thirteenth aspect of the invention, the rear end portion of the pin is engaged or fixed to the friction plate so that the movement in the left-right direction is restricted at least. Therefore, the push screw is screwed into the female screw with a small torque and the pin is not subjected to almost any force that tends to be pushed in the left-right direction with a large gap with the inner surface of the female screw part. There is an effect of improving reliability that can be pushed in smoothly.
 請求項15の発明によれば、請求項1乃至請求項14のいずれか1項の発明と同様な効果を有するのに加えて、前記椎体間固定装置が腹部側から腹腔鏡を併用した椎体間固定外科手術により椎体間に固定されることから、従来の背中側からの椎体間固定外科手術に比べて手術規模が大幅に縮小化されるとともに手術時間及び回復期間とも大幅に短縮できるため、患者や医者を含む医療スタッフの肉体及び精神的負担、患者の手術侵襲さらには経済的負担を著しく軽減することが可能となる効果がある。 According to the invention of claim 15, in addition to having the same effect as the invention of any one of claims 1 to 14, the interbody fusion device is a vertebra using a laparoscope in combination from the abdomen side. Because it is fixed between vertebral bodies by interbody fusion surgery, the operation scale is greatly reduced and the operation time and recovery period are also greatly reduced compared to the conventional interbody fusion surgery from the back side. Therefore, the physical and mental burden of the medical staff including the patient and the doctor, the surgical invasion of the patient, and the economic burden can be remarkably reduced.
 請求項16の発明によれば、請求項1乃至請求項15のいずれか1項の発明と同様な効果を有するのに加えて、本体嵌入ドライバーの後端把持部を把持して先端係合部に椎体間固定装置本体の後端部を係合した状態で内視鏡用腹腔部のカニューレ内に挿入された椎体間スペース保持装置の中空部内に挿入して押圧又は/及び回転することにより椎体間への椎体間固定装置本体の嵌入及び固定操作を容易化する効果がある。 According to the invention of claim 16, in addition to having the same effect as the invention of any one of claims 1 to 15, in addition to gripping the rear end grip portion of the body insertion driver, the tip engagement portion And inserting into the hollow portion of the interbody space holding device inserted into the cannula of the abdominal cavity for endoscope with the rear end of the interbody fusion device main body engaged with the body, and pressing or / and rotating. This has the effect of facilitating the fitting and fixing operation of the interbody fixing device body between the vertebral bodies.
 請求項17の発明によれば、請求項16の発明と同様な効果を有するのに加えて、本体嵌入ドライバーは、先端係合部を硬質な金属製で、シャフト部は軽量な樹脂などの高分子材料から構成することができるため全体が軽量化され、操作性を向上させる効果がある。 According to the invention of claim 17, in addition to having the same effect as that of the invention of claim 16, the main body insertion driver has a tip engaging portion made of hard metal and the shaft portion is made of a lightweight resin or the like. Since it can be composed of a molecular material, the whole is reduced in weight and has the effect of improving operability.
 請求項18の発明によれば、請求項16又は請求項17の発明と同様な効果を有するのに加えて、押圧ねじドライバーの後端把持部を把持して先端係合部に押圧ねじの後端部を係合した状態で前記本体嵌入ドライバーの中空部内に挿入し、押圧ねじを椎体間固定装置の本体の雌ねじ部に挿入して押圧しながら回転することにより雌ねじに螺合させその軸方向推進力により前記ピンの先端側を順次ガイド孔に沿って案内させながら椎体内に差込むことができ、本体主軸方向の一軸によるピン差込み固定操作を容易化する効果がある。 According to the invention of claim 18, in addition to having the same effect as that of the invention of claim 16 or claim 17, the rear end grip portion of the press screw driver is gripped and the tip engagement portion is placed behind the press screw. Inserted into the hollow part of the main body insertion driver with the end engaged, and inserted into the female screw part of the main body of the interbody fusion device and rotated while rotating, and screwed into the female screw. The pin can be inserted into the vertebral body while sequentially guiding the tip side of the pin along the guide hole by the direction propulsive force, and there is an effect of facilitating the pin insertion fixing operation by one axis in the main body main axis direction.
 請求項19の発明によれば、請求項18の発明と同様な効果を有するのに加えて、本体嵌入ドライバーが先端係合部を硬質な金属製で、シャフト部は軽量な樹脂などの高分子材料から構成することができるため全体が軽量化され、操作性を向上させる効果がある。 According to the nineteenth aspect of the present invention, in addition to having the same effect as the eighteenth aspect of the invention, the main body insertion driver has a tip engaging portion made of a hard metal, and the shaft portion is a lightweight polymer such as a resin. Since it can be comprised from a material, the whole is reduced in weight and there exists an effect which improves operativity.
 請求項20の発明によれば、2つの隣接する椎体間の適正な間隔を修正して椎間板スペースを保持する椎体間固定外科手術用椎体間スペース保持装置は、椎体クランプ機構の固定爪により隣接する椎体の左右両側面をそれぞれ挟持し固定することから、その後で椎体間固定装置を椎体間に移植固定する際に比較的大きな外力が負荷される椎体が後方又は左右の側方にずれないため椎体間固定外科手術における椎体間スペース保持の信頼性が確保される効果がある。 According to the twentieth aspect of the present invention, there is provided an interbody fusion surgical interbody space holding device that corrects an appropriate distance between two adjacent vertebral bodies to maintain an intervertebral disc space. Since the left and right side surfaces of adjacent vertebral bodies are sandwiched and fixed by the claws, the vertebral bodies to which a relatively large external force is applied when the interbody fusion device is subsequently implanted and fixed between the vertebral bodies are posterior or left and right Therefore, there is an effect that the reliability of the interbody space retention in the interbody fusion surgery is ensured.
 請求項21の発明によれば、請求項20の発明と同様な効果を有するのに加えて、第1のシャフト部に外嵌されたクランプアーム開閉管の前進又は後退により弾性支持部を有する各1対のクランプアームを縮径方向に閉じ又は拡径方向に開くことから、隣接する椎体の左右両側面をそれぞれ挟持し固定する椎体間スペース保持装置の構造及び操作が簡易化される効果がある。 According to the invention of claim 21, in addition to having the same effect as that of the invention of claim 20, each of the elastic support portions is provided by advancing or retreating the clamp arm opening / closing pipe fitted on the first shaft portion. Since a pair of clamp arms are closed in the diameter-reducing direction or opened in the diameter-enlarging direction, the structure and operation of the interbody space holding device that clamps and fixes the left and right side surfaces of adjacent vertebral bodies are simplified. There is.
 請求項22の発明によれば、請求項20の発明と同様な効果を有するのに加えて、椎体クランプ機構が第1のシャフト部の先端部に枢着された各1対のクランプアーム及び第2のシャフト部の先端部に枢着された各1対のリンク部材を備え、第2のシャフト部が前進又は後退することにより各1対のクランプアームを椎体の直交面内で縮径方向に閉じ又は拡径方向に開くトグル機構を構成したことから、隣接する椎体の左右両側面の挟持/固定力が強大化され、椎体間スペース保持装置の信頼性を一層向上させる効果がある。 According to the invention of claim 22, in addition to having the same effect as that of the invention of claim 20, each of the pair of clamp arms in which the vertebral body clamping mechanism is pivotally attached to the distal end portion of the first shaft portion, and Each pair of link members pivotally attached to the tip of the second shaft portion is provided, and each pair of clamp arms is reduced in diameter in the orthogonal plane of the vertebral body as the second shaft portion advances or retracts. Since the toggle mechanism that closes in the direction or opens in the diameter expansion direction is configured, the clamping / fixing force between the left and right sides of the adjacent vertebral bodies is increased, and the reliability of the interbody space holding device is further improved. is there.
 請求項23の発明によれば、請求項20乃至請求項22のいずれか1項の発明と同様な効果を有するのに加えて、固定爪の複数の尖鋭突起が椎体の側面に容易に突刺して椎体を強固に固定/保持する信頼性をさらに向上させる効果がある。 According to the invention of claim 23, in addition to having the same effect as that of any one of claims 20 to 22, the plurality of sharp protrusions of the fixed claw can be easily pierced on the side surface of the vertebral body. Thus, there is an effect of further improving the reliability of firmly fixing / holding the vertebral body.
 請求項24の発明によれば、2つの隣接する椎体間の適正な間隔を修正して椎間板スペースを保持する椎体間固定外科手術用椎体間スペース保持装置は、第1のシャフト部の外面及び先端部にそれぞれ設けられた長尺固定ねじ部材及び針状突起により、前記隣接する椎体の一方又は両方の前面部にそれぞれ螺入、突刺して抜け止め効果を伴って固定することから、椎体間スペース保持装置の構造及び操作が簡易であるとともに、その後で椎体間固定装置を椎体間に移植固定する際に比較的大きな外力が負荷される椎体が後方又は左右の側方にずれないため椎体間固定外科手術における椎体間スペース保持の信頼性が確保される効果がある。 According to the invention of claim 24, an interbody fusion space holding device for interbody fusion surgery that corrects an appropriate distance between two adjacent vertebral bodies and holds an intervertebral disc space is provided on the first shaft portion. From a long fixing screw member and a needle-like projection provided on the outer surface and the distal end, respectively, one or both front surfaces of the adjacent vertebral bodies are respectively screwed and pierced to be fixed with a retaining effect. The structure and operation of the interbody space holding device is simple and the vertebral body to which a relatively large external force is applied when the interbody fusion device is subsequently implanted and fixed between the vertebral bodies is located on the posterior or left and right sides. Therefore, the reliability of the interbody space retention in the interbody fusion surgery is ensured.
 請求項25の発明によれば、請求項20乃至請求項24のいずれか1項の発明と同様な効果を有するのに加えて、1つの椎体間スペース保持装置に椎体クランプ機構又は長尺固定ねじ部材/針状突起と椎間板スペース内に挿入されることにより隣接する椎体を適正な間隔に修正して保持する外形形状を有する1対のスペーサーとを兼備することから、椎体間固定外科手術における隣接する椎体の適正な間隔に修正及び固定/保持が同時に短時間で行うことができる。これにより、従来の椎体間固定外科手術に比べて手術時間が短縮できるため、患者や医者を含む医療スタッフの肉体及び精神的負担、患者の手術侵襲さらには経済的負担を軽減する効果がある。 According to the invention of claim 25, in addition to having the same effect as that of the invention of any one of claims 20 to 24, a vertebral body clamping mechanism or a long length is provided in one interbody space holding device. Intervertebral body fixation because it combines a fixed screw member / needle-like process and a pair of spacers having an outer shape that holds the adjacent vertebral bodies at appropriate intervals by being inserted into the intervertebral disc space. Correction and fixation / holding can be performed simultaneously in a short time at an appropriate interval between adjacent vertebral bodies in a surgical operation. As a result, the operation time can be shortened as compared with the conventional interbody fusion surgery, thereby reducing the physical and mental burden of medical staff including patients and doctors, the surgical invasion of the patient, and the economic burden. .
本発明の一実施形態(実施例1)の椎体間固定外科手術システムの概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fusion surgery system of one Embodiment (Example 1) of this invention. 本発明の実施例1の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of Example 1 of this invention. 図2のA-A矢視図である。FIG. 3 is an AA arrow view of FIG. 2. (a)は図2のB-B矢視断面図、(b)は図2のC-C矢視断面図である。(A) is a cross-sectional view taken along the line BB in FIG. 2, and (b) is a cross-sectional view taken along the line CC in FIG. (a)、(b)、(c)、(d)、(e)、(f)は、それぞれ本発明の別の変形実施形態のピンの概念を示す一部断面図である。(A), (b), (c), (d), (e), (f) is a partial sectional view showing a concept of a pin of another modified embodiment of the present invention. 図2のD-D矢視断面図である。FIG. 3 is a sectional view taken along the line DD in FIG. 2. 図2の平面図である。FIG. 3 is a plan view of FIG. 2. 図2の椎体間固定装置本体の椎体間への嵌入状態を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the insertion state between the vertebral bodies of the interbody fixing device main body of FIG. 図2の椎体間固定装置の椎体間への固定完了状態を示す縦断面図(主要部断面)である。FIG. 3 is a longitudinal sectional view (main section) showing a state of fixation between vertebral bodies of the interbody fusion device of FIG. 2. 図9のE-E矢視図である。FIG. 10 is an EE arrow view of FIG. 9. 本発明の別の実施形態(実施例2)の椎体間固定装置の椎体間への固定完了状態を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the fixation completion state between the vertebral bodies of the interbody fixing device of another embodiment (Example 2) of this invention. 図11のF-F矢視図である。FIG. 12 is an FF arrow view of FIG. 11. 本発明のまた別の実施形態(実施例3)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 3) of this invention. 図13のP-P矢視図である。It is a PP arrow line view of FIG. 本発明のまた別の実施形態(実施例4)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 4) of this invention. (a)は図15の摩擦板部のG-G矢視断面図、(b)は(a)のH-H矢視断面図である。15A is a cross-sectional view taken along the line GG of the friction plate portion of FIG. 15, and FIG. 15B is a cross-sectional view taken along the line HH of FIG. 本発明のまた別の実施形態(実施例5)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 5) of this invention. 図17のQ-Q矢視図である。It is a QQ arrow line view of FIG. 図17の平面図である。It is a top view of FIG. 本発明のさらに別の実施形態(実施例6)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 6) of this invention. 図20のR-R矢視図である。FIG. 21 is an RR arrow view of FIG. 20. 図20の平面図である。It is a top view of FIG. 本発明のまた別の実施形態(実施例7)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 7) of this invention. (a)は本発明のまた別の実施形態(実施例8)の椎体間固定装置の概念を示す縦断面図(主要部断面)、(b)は(a)のI-I矢視要部断面図である。(A) is the longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 8) of this invention, (b) is II arrow view required of (a). FIG. 本発明のまた別の実施形態(実施例9)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 9) of this invention. 本発明のさらに別の実施形態(実施例10)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 10) of this invention. 本発明の一実施形態の椎体間スペース保持装置の概念を示す縦断面図(上半部断面)である。It is a longitudinal cross-sectional view (upper half cross section) which shows the concept of the interbody space holding | maintenance apparatus of one Embodiment of this invention. 図27の椎体間スペース保持装置の平面図(上半部断面)である。It is a top view (upper half cross section) of the interbody space holding device of FIG. 図27のU-U矢視図である。FIG. 28 is a view taken from the direction of the arrows U-U in FIG. 27. 本発明の別の実施形態の椎体間スペース保持装置の概念を示す平面図(上半部断面)である。It is a top view (upper half cross section) which shows the concept of the interbody space holding | maintenance apparatus of another embodiment of this invention. 図30の椎体間スペース保持装置の縦断面図(上半部断面)である。It is a longitudinal cross-sectional view (upper half cross section) of the interbody space holding device of FIG. 図31のV-V矢視図である。FIG. 32 is a view on arrow VV of FIG. 31. 本発明のさらに別の実施形態の椎体間スペース保持装置の概念を示す縦断面図(上半部断面)である。It is a longitudinal cross-sectional view (upper half cross section) which shows the concept of the interbody space holding | maintenance apparatus of another embodiment of this invention. 図33の椎体間スペース保持装置の平面図(上半部断面)である。FIG. 34 is a plan view (upper half section) of the interbody space holding device of FIG. 33. 図34のW-W矢視図である。FIG. 35 is a view on arrow WW in FIG. 34. 本発明の一実施形態の本体嵌入ドライバーの概念を示す縦断面図(上半部断面)である。It is a longitudinal cross-sectional view (upper half part cross section) which shows the concept of the main body insertion driver of one Embodiment of this invention. 図36のS-S矢視図である。FIG. 37 is a view taken along the line SS of FIG. 36. 本発明の一実施形態の押圧ねじドライバーの概念を示す側面図である。It is a side view which shows the concept of the press screw driver of one Embodiment of this invention. 図38のT-T矢視図である。FIG. 39 is a view on arrow TT in FIG. 38. 本発明の図33の椎体間スペース保持装置を適用した変形実施形態の椎体間固定外科手術システムの概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fusion surgery system of the deformation | transformation embodiment to which the interbody space holding | maintenance apparatus of FIG. 33 of this invention is applied. (a)は本発明の一実施形態の椎体間固定外科手術における患者の砕石位状態を概念的に示す側面図、(b)は(a)に引続き患者のトレンデレンブルグ体位状態を概念的に示す側面図である。(A) is a side view conceptually showing a patient's lithotripsy state in the interbody fusion surgery of one embodiment of the present invention, and (b) is a conceptual view of a patient's Trendelenburg position following (a). FIG. 本発明の一実施形態の椎体間固定外科手術における患者の腹部側の腹腔鏡用ポートの配置状態を概念的に示す平面図である。It is a top view which shows notionally the arrangement | positioning state of the laparoscopic port of the patient's abdominal side in the interbody fusion surgery of one Embodiment of this invention. 本発明の一実施形態の椎体間固定外科手術における患者の腹部側からの処置工程を概念的に示す側面図である。It is a side view which shows notionally the treatment process from the abdomen side of the patient in the interbody fusion surgery of one Embodiment of this invention. 本発明のまた別の実施形態(実施例11)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 11) of this invention. 図44のX-X矢視図である。FIG. 45 is a view on arrow XX in FIG. 44. 本発明のさらに別の実施形態(実施例12)の椎体間固定装置の概念を示す縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) which shows the concept of the interbody fixing device of another embodiment (Example 12) of this invention. 図46のY-Y矢視図である。FIG. 47 is a view on arrow YY in FIG. 46. 従来の第1例の椎体間固定装置の斜視図である。It is a perspective view of the conventional interbody fusion device of the first example. 従来の第2例の椎体間固定装置が椎体間に固定された状態の縦断面図(主要部断面)である。It is a longitudinal cross-sectional view (main part cross section) of the state by which the conventional interbody fixing device of the 2nd example was fixed between vertebral bodies. 従来の代表的な椎体間スペース保持装置(腹側前弯症伸長外部スリーブ)の斜視図である。It is a perspective view of the conventional typical interbody space holding | maintenance apparatus (ventral side lordosis extension external sleeve). 図50の椎体間スペース保持装置(腹側前弯症伸長外部スリーブ)が椎体間に挿入された状態の側面図である。FIG. 52 is a side view showing a state in which the interbody space holding device (ventral ventral lordosis extending external sleeve) of FIG. 50 is inserted between vertebral bodies.
 以下、本発明の椎体間固定外科手術システム、外科手術方法及び椎体間スペース保持装置を最良に実施するための形態の具体例を、添付図面を参照しながら詳細に説明する。 Hereinafter, specific examples of the best mode for carrying out the interbody fusion surgery system, the surgical method, and the interbody space holding device of the present invention will be described in detail with reference to the accompanying drawings.
 図1は本発明の一実施形態(実施例1)の椎体間固定外科手術システムの主要構成概念を示す縦断面図(主要部断面)、図2は本発明の実施例1の椎体間固定装置10の概念を示す縦断面図(主要部断面)、図3は図2のA-A矢視断面図、図4(a)、(b)はそれぞれ図2のB-B矢視断面図、C-C矢視断面図、図5(a)、(b)、(c)、(d)、(e)、(f)はそれぞれ本発明の別の変形実施形態のピンの概念を示す一部断面図、図6は図2のD-D矢視断面図、図7は図2の平面図、図8は椎体間固定装置10の椎体L1、L2間への嵌入状態を示す縦断面図(主要部断面)、図9は椎体間固定装置10の椎体L1、L2間への固定完了状態を示す縦断面図(主要部断面)、図10は図9のE-E矢視図である。なお、ここに添付した図面は、いずれも内部構造を分かり易くするため軸方向に比べて径方向を拡大してノットスケールで表現された主要構成概念を示す概念図である。 FIG. 1 is a longitudinal sectional view (main section) showing a main configuration concept of an interbody fusion surgical system according to an embodiment (Example 1) of the present invention, and FIG. 2 is an intervertebral body of Example 1 of the present invention. FIG. 3 is a sectional view taken along the line AA in FIG. 2, and FIGS. 4A and 4B are sectional views taken along the line BB in FIG. FIGS. 5A, 5B, 5C, 5C, 5D, 5E, 5F, and 5F are cross-sectional views taken along arrows CC, respectively. 6 is a cross-sectional view taken along the line DD of FIG. 2, FIG. 7 is a plan view of FIG. 2, and FIG. 8 is a diagram showing a state where the interbody fusion device 10 is inserted between the vertebral bodies L1 and L2. 9 is a longitudinal sectional view (cross section of the main part), FIG. 9 is a longitudinal sectional view (cross section of the main part) showing a state of fixation between the vertebral bodies L1 and L2 of the interbody fusion device 10, and FIG. FIG. Each drawing attached here is a conceptual diagram showing the main structural concept expressed in knot scale by enlarging the radial direction compared to the axial direction in order to make the internal structure easy to understand.
 本発明の一実施形態の椎体間固定外科手術システムは、図1に示すように、前端有底の略中空円筒状の外面に椎体L1、L2間に係合して嵌入される雄ねじ状の外面係合部14、15が形成され、後端側中空内面16aに設けられた雌ねじ16内面から椎体方向に末広がりに外面まで貫通する1つ又は複数のガイド孔17、18が穿設された本体11、ガイド孔内に遊嵌収容された1つ又は複数のピン30、及び雌ねじ16に螺合しピン後端を押圧してピンの先端側をガイド孔に沿って椎体内に差込む押圧ねじ40を有し、2つの隣接する椎体(椎骨)L1、L2間の椎間板スペースMに嵌入して椎体L1、L2を固定する椎体間固定装置10と、椎体間固定装置10を椎体L1、L2間に移植固定するのに先立ち、生体例えば人体MNの腹部MN1側から椎体L1、L2間の中心に向けて穿設された内視鏡用ポートMa内に挿入されるカニューレKと、カニューレK内に挿入し、椎体L1、L2間の適正な間隔を修正して椎間板スペースMを保持するための椎体間スペース保持装置70と、先端係合部83に椎体間固定装置10の本体11の後端係合部29に係合した状態で椎体間スペース保持装置70の中空部内に挿入し、本体11を押圧し回転して椎体L1、L2間に嵌入させる本体嵌入ドライバー80と、先端係合部93に椎体間固定装置10の押圧ねじ40の後端係合部44に係合した状態で本体嵌入ドライバー80の中空内に挿入し、押圧ねじ40を本体11の雌ねじ部16に挿入し押圧しながら螺入させる押圧ねじドライバー90と、を具備する。 As shown in FIG. 1, the interbody fusion surgical system according to an embodiment of the present invention is a male screw shape that is engaged and fitted between vertebral bodies L1 and L2 on a substantially hollow cylindrical outer surface having a front end. Outer surface engaging portions 14 and 15 are formed, and one or a plurality of guide holes 17 and 18 penetrating from the inner surface of the female screw 16 provided on the rear end side hollow inner surface 16a to the outer surface so as to extend toward the vertebral body are formed. The main body 11, one or a plurality of pins 30 loosely accommodated in the guide hole, and the female screw 16 are screwed together and the rear end of the pin is pressed so that the distal end side of the pin is inserted into the vertebral body along the guide hole. An intervertebral body fixing device 10 that has a pressing screw 40 to be inserted and fits into an intervertebral disc space M between two adjacent vertebral bodies (vertebrae) L1 and L2, and fixes the vertebral bodies L1 and L2. Prior to transplantation and fixation of 10 between the vertebral bodies L1 and L2, A cannula K inserted into the endoscope port Ma drilled from the side of the part MN1 toward the center between the vertebral bodies L1 and L2, and inserted into the cannula K, and an appropriate distance between the vertebral bodies L1 and L2 In a state where the intervertebral space holding device 70 for holding the intervertebral disc space M by correcting the interval and the distal end engaging portion 83 engaged with the rear end engaging portion 29 of the main body 11 of the interbody fixing device 10. The interbody fixing device 10 is inserted into the hollow portion of the interbody space holding device 70, the main body 11 is pressed and rotated to be inserted between the vertebral bodies L1 and L2, and the intervertebral body fixing device 10 is inserted into the distal end engaging portion 93. A press screw driver 90 is inserted into the hollow of the main body insertion driver 80 in a state of being engaged with the rear end engaging portion 44 of the press screw 40, and the press screw 40 is inserted into the female screw portion 16 of the main body 11 and screwed while being pressed. And.
 さらに、椎体間固定外科手術の際に観察及び各種事前/事後の処置をするため、いずれも図示しない別途複数の内視鏡用腹腔から挿入される内視鏡(又は腹腔鏡)あるいは本体嵌入ドライバー80中空内に収設されるカプセル内視鏡等を備えることが望ましい。 Furthermore, in order to perform observation and various pre / post treatments during interbody fusion surgery, an endoscope (or a laparoscope) or a main body is inserted through a plurality of endoscope abdominal cavity (not shown). It is desirable to provide a capsule endoscope or the like housed in the hollow of the driver 80.
 本発明の実施例1の椎体間固定装置10は、椎体L1、L2間の適正な間隔に適合する前端有底の略中空円筒状に形成され、外面に椎体L1、L2の対向面L1a、L2a部に外面頭頂部が係合して嵌入される雄ねじ状の外面係合部14、15が形成された本体11と、本体11の後端面13側の中空内面16aに形成された雌ねじ16と、雌ねじ16の奥行き部から椎体L1、L2の対向面L1a、L2aに向かって径方向に略軸対称な末広がりに傾斜して外面まで貫通し穿設された1対のガイド孔17、18と、雌ねじ16内に本体11の主軸C1に沿って遊嵌収容され、先端32側がそれぞれ1対のガイド孔17、18に沿って案内され屈曲し挿通された1対のピン30、30と、雌ねじ16に螺合しその軸方向推進力により、ピン30、30の後端31、31を押圧する押圧ねじ40と、から概略構成されている。 The interbody fusion device 10 according to the first embodiment of the present invention is formed in a substantially hollow cylindrical shape with a front end that fits an appropriate distance between the vertebral bodies L1 and L2, and the opposing surface of the vertebral bodies L1 and L2 on the outer surface. A main body 11 formed with external thread engaging parts 14 and 15 into which outer surface tops engage with L1a and L2a parts, and a female thread formed on a hollow inner surface 16a on the rear end face 13 side of the main body 11 16 and a pair of guide holes 17 inclined from the depth of the female screw 16 toward the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2 in a radially axially symmetric shape and penetrating to the outer surface, 18 and a pair of pins 30, 30 that are loosely fitted and accommodated in the female screw 16 along the main axis C 1 of the main body 11, and whose distal end 32 side is guided along a pair of guide holes 17, 18, bent, and inserted, respectively. The pin 3 is screwed into the female screw 16 and its axial propulsive force The press screw 40 that presses the rear ends 31 and 31 of 0 and 30 is schematically configured.
 本体11は、椎体L1、L2間の適正な間隔を保持するように形成された外形を有し、2つの椎体L1、L2の対向面L1a、L2a間がほぼ平行面あるいは背部側方向に減縮する例えば水平面に対して9°前後の傾斜面形状となっている場合に対応するように図1に示すような略中空円筒で、中央部外径が僅かに例えば0.1mmオーダー太めの太鼓状に形成される。本体11は、椎体L1、L2の太さすなわち奥行きなどの大きさによるが、椎体L1、L2間に収容される例えば概ね外径が18~22mmで、全長が25mm~45mm程度である。この場合、本体11の前端面12は、凸曲面又は図示しない略円錐面状に形成され、脊柱の背後の神経部に触れないよう神経部の十分手前の椎体L1、L2間に配置されることが必要である。 The main body 11 has an outer shape formed so as to maintain an appropriate distance between the vertebral bodies L1 and L2, and the opposing surfaces L1a and L2a of the two vertebral bodies L1 and L2 are substantially parallel or dorsal. For example, a drum with a substantially hollow cylinder as shown in FIG. 1 whose outer diameter is slightly thicker, for example, on the order of 0.1 mm, so as to correspond to the case of an inclined surface shape of about 9 ° with respect to a horizontal plane. It is formed in a shape. The main body 11 is accommodated between the vertebral bodies L1 and L2, for example, having an outer diameter of approximately 18 to 22 mm and a total length of approximately 25 to 45 mm, depending on the size of the vertebral bodies L1 and L2. In this case, the front end surface 12 of the main body 11 is formed in a convex curved surface or a substantially conical surface not shown, and is disposed between the vertebral bodies L1 and L2 sufficiently in front of the nerve portion so as not to touch the nerve portion behind the spinal column. It is necessary.
 本体11は、椎体L1、L2間の強大な例えば1000kgオーダーの圧縮力に耐える十分な強度及び生物学的適合性を有する材料あるいは不活性材料から形成される。これらの材料としては、例えば、医療等級のステンレス鋼(SUS)、チタン(Ti)、多孔性タンタル複合材料等の多孔性材料などがあり、特に強度及び軽量な点からはTiが好適である。 The main body 11 is formed of a material having sufficient strength and biological compatibility to withstand a strong compressive force between the vertebral bodies L1 and L2, for example, on the order of 1000 kg, or an inert material. Examples of these materials include porous materials such as medical grade stainless steel (SUS), titanium (Ti), and a porous tantalum composite material. Ti is particularly preferable from the viewpoint of strength and light weight.
 本体11の外面には、椎体L1、L2の対向面L1a、L2a部に外面頭頂部が食い込み係合する外面係合部として雄ねじ14、15が形成される。雄ねじ14、15の谷径が椎体L1、L2の対向面L1a、L2a間距離にほぼ接触する程度が望ましく、雄ねじ14、15のねじ山高さは例えば概ね3~4mm弱程度である。雄ねじ14、15は、脊椎に加わる高荷重により本体11が椎体L1、L2間から押し出されないよう椎体L1、L2内に十分に係合することが望ましい。雄ねじ14、15のピッチは、椎体間固定装置10を椎体L1、L2間の所定の位置に保持するのに必要なねじ係合量に応じて、例えば概ね2~3mm程度である。雄ねじ14、15のねじ山高さ及びピッチは、必要に応じて上記より小さい値に形成することができることはいうまでもない。 External threads 14 and 15 are formed on the outer surface of the main body 11 as outer surface engaging portions in which the outer surface crown portion bites into and engages the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2. It is desirable that the valley diameter of the male screws 14 and 15 is substantially in contact with the distance between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2. The thread height of the male screws 14 and 15 is, for example, about 3 to 4 mm. The male screws 14 and 15 are desirably sufficiently engaged in the vertebral bodies L1 and L2 so that the main body 11 is not pushed out between the vertebral bodies L1 and L2 due to a high load applied to the spine. The pitch of the male screws 14 and 15 is, for example, about 2 to 3 mm, depending on the amount of screw engagement required to hold the interbody fusion device 10 at a predetermined position between the vertebral bodies L1 and L2. Needless to say, the thread height and pitch of the male threads 14, 15 can be formed to a value smaller than the above as required.
 この実施例では、図3、4、6、7に示すように、本体11は前端面12側を残して後方の外面の左右両側の頭頂部が適宜な幅でカットされた略平行なカット側面19、19が形成されている。従って、前端面12側の雄ねじ15は全周完全ねじであるが、その後方のカット側面19、19が形成された断面部分円筒の上下外面に形成された雄ねじ14は部分ねじとなっている。雄ねじ14、15の軸方向先端(ねじ端)及び径方向外面頭頂部は尖鋭刃状に形成されており、前端面12側の完全ねじである雄ねじ15は、先頭ねじとして本体11を椎体L1、L2間に容易に螺入させることができる。 In this embodiment, as shown in FIGS. 3, 4, 6, and 7, the main body 11 is a substantially parallel cut side surface in which the tops on both the left and right sides of the rear outer surface are cut with an appropriate width, leaving the front end face 12 side. 19 and 19 are formed. Therefore, the male screw 15 on the front end face 12 side is a full screw, but the male screw 14 formed on the upper and lower outer surfaces of the cross-section partial cylinder in which the cut side faces 19 and 19 on the rear side are formed is a partial screw. The axial front ends (screw ends) and the radial outer surface crests of the male screws 14 and 15 are formed in a sharp blade shape, and the male screw 15 which is a complete screw on the front end surface 12 side uses the main body 11 as a vertebral body L1. , L2 can be easily screwed in.
 本体11の全長に亘りカット側面19、19を形成した場合は、本体11を図示90°横にすれば本体11をねじ込まなくても椎体L1、L2の対向面L1a、L2a間に容易に挿入することもできる。この場合は、本体11を椎体L1、L2間に挿入後90°回転して縦てることにより、図8に示すように、本体11が椎体L1、L2間の適正な間隔を保持して固定される。また、カット側面19、19は、椎体L1、L2の対向面L1a、L2a間で骨の内部成長による骨状固定のための領域を提供するのに好適となる。 When the cut side surfaces 19 and 19 are formed over the entire length of the main body 11, the main body 11 can be easily inserted between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2 without screwing the main body 11 if the main body 11 is turned 90 ° in the figure. You can also In this case, the main body 11 is rotated 90 ° after being inserted between the vertebral bodies L1 and L2, and is held vertically so that the main body 11 maintains an appropriate distance between the vertebral bodies L1 and L2, as shown in FIG. Fixed. The cut side surfaces 19 and 19 are suitable for providing a region for bone-like fixation by bone ingrowth between the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2.
 また、本体11のカット側面19、19の後端部は、椎体間固定装置10の椎体L1、L2間への挿入固定に際し、いずれも図示しない移植ドライバーのシャフトの先端に設けられたトング(挟持具)により把持されるようにもなっている。なお、上記移植ドライバーは公知のものを利用することができるが、本体11を椎体L1、L2間に嵌入させる本発明の一実施形態の本体嵌入ドライバーについては後述する。 Further, the rear end portions of the cut side surfaces 19 and 19 of the main body 11 are provided at the tip of the shaft of the transplant driver (not shown) when the interbody fusion device 10 is inserted and fixed between the vertebral bodies L1 and L2. It can also be held by a (holding tool). Although a known one can be used as the transplant driver, a main body insertion driver according to an embodiment of the present invention in which the main body 11 is inserted between the vertebral bodies L1 and L2 will be described later.
 本体11の後端面13側から穿設された中空内面16aには、適宜奥行きの雌ねじ16が形成されるとともに、雌ねじ16の奥行き部の中空内面16aから椎体L1、L2方向に略軸対称に末広がりに主軸C1に対し傾斜角Θ1、Θ2の傾斜軸C2、C3に沿って外面まで貫通する上下1対のガイド孔17、18が穿設されている。傾斜角Θ1、Θ2は、椎体L1、L2の配置状況及びピン30の太さや可撓性等の状況に応じて適宜決定され、両者は略等しい又は若干異なる傾斜角に設定してもよい。同一条件では、ピン30の押し込み力は傾斜角Θ1、Θ2にほぼ比例するような傾向を示す。 A hollow inner surface 16a drilled from the rear end surface 13 side of the main body 11 is formed with a female screw 16 having an appropriate depth, and is substantially axisymmetric in the vertebral body L1 and L2 directions from the hollow inner surface 16a of the depth portion of the female screw 16. A pair of upper and lower guide holes 17 and 18 penetrating to the outer surface along the inclined axes C2 and C3 of the inclination angles Θ1 and Θ2 with respect to the main axis C1 are formed at the end. The inclination angles Θ1 and Θ2 are appropriately determined according to the arrangement state of the vertebral bodies L1 and L2 and the situation such as the thickness and flexibility of the pin 30, and both may be set to be substantially equal or slightly different inclination angles. Under the same conditions, the pushing force of the pin 30 tends to be substantially proportional to the inclination angles Θ1 and Θ2.
 なお、いずれも図示しないが、傾斜軸C2、C3は、ピン30の先端32が押し込まれて椎体L1、L2の外面からはみ出さない限り、主軸C1に対しそれぞれ任意の方向に且つ非対称に配置されてもよく、あるいは主軸C1に対し偏心し且つ任意の方向の面内に配置されてもよい。 Although not shown, the inclined axes C2 and C3 are arranged in any direction and asymmetrically with respect to the main axis C1 as long as the distal end 32 of the pin 30 is not pushed and protrudes from the outer surface of the vertebral bodies L1 and L2. Alternatively, it may be eccentric with respect to the main axis C1 and arranged in a plane in any direction.
 また、本体11には、図2~4、6、7等に示すように、側面開口21、22、23及び上下面開口24、25、26などの複数の開口が穿設されている。そして、図2~4等に示すように、中空内面16aの先端面に側面開口21及び上下面開口24とも連通する小穴28が穿設されている。側面開口21、22、23は椎体L1、L2を囲繞する高度に血管化された組織に接触して血管新生を促進し、上下面開口24、25、26は椎体L1、L2の対向面L1a、L2a間で骨の内部成長による骨状固定を促進する。このため、本体11には強度を損なわない限り多数の開口を極力相互に連通するように穿設することが望ましい。 Further, as shown in FIGS. 2 to 4, 6, 7, etc., the main body 11 has a plurality of openings such as side openings 21, 22, 23 and upper and lower openings 24, 25, 26. As shown in FIGS. 2 to 4 and the like, a small hole 28 communicating with the side surface opening 21 and the upper and lower surface openings 24 is formed in the distal end surface of the hollow inner surface 16a. The side openings 21, 22, 23 contact the highly vascularized tissue surrounding the vertebral bodies L1, L2 to promote angiogenesis, and the upper and lower surface openings 24, 25, 26 are opposite surfaces of the vertebral bodies L1, L2. Bone-like fixation by bone ingrowth is promoted between L1a and L2a. For this reason, it is desirable to drill a large number of openings in the main body 11 so as to communicate with each other as much as possible unless the strength is impaired.
 さらに、本体11の後端面13には、1対の後端開口27、27及び円周部に沿って複数例えば6個の部分円弧状開口が穿設されている。この部分円弧状開口は、本体11を椎体L1、L2間に嵌入するための後述の本体嵌入ドライバーの先端係合部が嵌合して係合する後端係合部29である。後端係合部29は、このような部分円弧状開口に代えて、後端面13面に例えばいずれも図示しない六角形の凹溝を設けて本体嵌入ドライバーの六角形状の先端係合部を係合させるようにしてもよい。 Furthermore, the rear end surface 13 of the main body 11 has a pair of rear end openings 27 and 27 and a plurality of, for example, six partial arc-shaped openings formed along the circumferential portion. This partial arc-shaped opening is a rear end engaging portion 29 in which a front end engaging portion of a main body insertion driver described later for fitting the main body 11 between the vertebral bodies L1 and L2 is engaged and engaged. The rear end engaging portion 29 is provided with, for example, a hexagonal concave groove (not shown) on the rear end surface 13 in place of such a partial arc-shaped opening to engage the hexagonal front end engaging portion of the main body insertion driver. You may make it match.
 なお、本体11に多孔性タンタル-カーボン複合材料例えば米国インプレックス社の商品名「ヘドロセル(HEDROCEL)」などの多孔性材料を用いる場合は、上記のような側面開口21、22、23及び上下面開口24、25、26を設けなくてもよく、相互に連結された多孔部が骨の内部成長及び血管新生を促進することができる。この多孔性材料は、多孔質の骨の構造に似ているとともに、人体の骨の弾性率に近い弾性率を有していることから、本発明の椎体間固定装置には最適とも言える。 When the main body 11 is made of a porous tantalum-carbon composite material, for example, a porous material such as “HEDROCEL” (trade name of US Implex Co., Ltd.), the side openings 21, 22, 23 and the upper and lower surfaces as described above are used. The openings 24, 25, and 26 may not be provided, and the interconnected porous portions may promote bone ingrowth and angiogenesis. This porous material resembles the structure of a porous bone and has an elastic modulus close to that of a human bone, so it can be said to be optimal for the interbody fusion device of the present invention.
 1対のピン30、30は、雌ねじ16内に上下に主軸C1方向に並列して遊嵌収容され、それぞれ後端31側が本体11の主軸C1に沿って延伸するとともに先端32側がそれぞれ1対のガイド孔17、18に沿って案内され屈曲し挿通される。各先端32は、適宜尖鋭状に形成され、本体11が椎体L1、L2間に差込まれる前の初期状態においては雄ねじ14の谷径以内に、すなわち谷径から突出しないようガイド孔17、18の出口内に収容されている。 The pair of pins 30, 30 are loosely accommodated in the female screw 16 in parallel in the direction of the main axis C <b> 1, the rear end 31 side extends along the main axis C <b> 1 of the main body 11, and the front end 32 side is a pair each. It is guided along the guide holes 17 and 18, bent and inserted. Each tip 32 is appropriately sharpened, and in the initial state before the main body 11 is inserted between the vertebral bodies L1 and L2, the guide holes 17 and so on do not protrude from the valley diameter of the male screw 14, that is, from the valley diameter. It is accommodated in 18 outlets.
 この実施例のピン30は、丸あるいは多角形など任意断面形状の中実又は中空の棒状体からなり、図3~4等に示すように、例えば一辺が数mm程度の四角棒材で、Ti製の本体より柔らかく、適宜な屈曲性及び強度のある例えば医療等級のSUSなどからなる。 The pin 30 of this embodiment is formed of a solid or hollow rod-like body having an arbitrary cross-sectional shape such as a circle or a polygon. For example, as shown in FIGS. It is softer than the main body and is made of, for example, medical grade SUS having appropriate flexibility and strength.
 また、この実施例の中実又は中空の一体型棒状体からなるピン30に替えて、図4(a)又は(b)におけると同様な方向のピンの一部断面図である図5(a)~(f)に示すように、少なくとも先端側又は全長に亘り複数の薄板材30An、30Dn又は丸や各種扁平断面等任意断面型を有する線材30Bn、30En、30Cn、30Fnが積層されて一体的な丸あるいは多角形など任意断面形状の棒状積層体からなるそれぞれ別の変形形態のピン30A、30B、30C、30D、30E、30Fとすることもできる。 Moreover, it replaces with the pin 30 which consists of a solid or hollow integrated rod-shaped body of this Example, and is a partial sectional view of the pin in the same direction as in FIG. 4A or FIG. ) To (f), a plurality of thin plate materials 30An, 30Dn or wire rods 30Bn, 30En, 30Cn, 30Fn having an arbitrary cross-sectional shape such as a round shape or various flat cross-sections are laminated and integrated at least over the tip side or the entire length. The pins 30A, 30B, 30C, 30D, 30E, and 30F may be different from each other in the form of a rod-like laminate having an arbitrary cross-sectional shape such as a round shape or a polygonal shape.
 変形形態のピン30A、30B、30Cは、それぞれ図5(a)、(b)、(c)に示すように、少なくとも先端側又は全長に亘り複数の薄板材30An、丸型線材30Bn、長円扁平型線材30Cnが積層されて一体的な略四角形断面形状の棒状積層体に形成される。 As shown in FIGS. 5A, 5B, and 5C, the deformed pins 30A, 30B, and 30C each include a plurality of thin plate materials 30An, a round wire 30Bn, and an oval shape at least on the distal end side or the entire length. The flat wire rods 30Cn are laminated to form a rod-like laminate having an integral substantially square cross section.
 変形形態のピン30D、30E、30Fは、それぞれ図5(d)、(e)、(f)に示すように、少なくとも先端側又は全長に亘り幅の異なる複数の薄板材30Dn、丸型線材30En、長円扁平型線材30Fnが積層されて一体的な略菱形断面形状の棒状積層体に形成される。 As shown in FIGS. 5D, 5E, and 5F, the deformed pins 30D, 30E, and 30F include a plurality of thin plate materials 30Dn and round wire rods 30En having different widths at least on the tip side or the entire length, respectively. The oblong flat wire 30Fn is laminated to form a rod-like laminated body having a substantially rhombic cross section.
 このような積層体からなる変形形態のピン30A、30B、30C、30D、30E、30Fは、形状を保持するために根元部の薄板材30An、30Dn又は線材30Bn、30En、30Cn、30Fnをそれぞれ相互に接着又は溶着して一体的に形成されることが望ましい。これにより、先端部側は各薄板材30An、30Dn又は線材30Bn、30En、30Cn、30Fnが各々フリーな状態であるため本体11のガイド孔17、18に沿って案内され比較的容易に屈曲し易くなり、本体のガイド孔に沿ってスムースに案内される操作性が向上する。さらに、これらの積層体からなるピン30A~30Fは、任意の形状に一体的に積層し形成することが容易であり、設計の自由度が向上する。 The deformed pins 30A, 30B, 30C, 30D, 30E, and 30F made of such a laminate are mutually connected to the thin plate members 30An and 30Dn or the wire rods 30Bn, 30En, 30Cn, and 30Fn at the base portion in order to maintain the shape. It is desirable to be integrally formed by bonding or welding to each other. As a result, since the thin plate members 30An, 30Dn or the wire rods 30Bn, 30En, 30Cn, 30Fn are in a free state, the distal end side is guided along the guide holes 17 and 18 of the main body 11 and can be bent relatively easily. Thus, the operability of being smoothly guided along the guide hole of the main body is improved. Further, the pins 30A to 30F made of these laminates can be easily laminated and formed in an arbitrary shape, and the degree of design freedom is improved.
 そこで、雌ねじ16及び中空内面16aの内径は、ピン30あるいは30A~30Fの太さ及び本体11の外径ならびにこの両者の強度等の兼ね合いから適宜決定される。中空内面16aは、雌ねじ16の下孔の役割をも有している。 Therefore, the inner diameters of the female screw 16 and the hollow inner surface 16a are appropriately determined from the balance of the thickness of the pin 30 or 30A to 30F, the outer diameter of the main body 11, the strength of both, and the like. The hollow inner surface 16a also serves as a pilot hole for the female screw 16.
 押圧ねじ40は、図8、9に示すように、本体11の雌ねじ16に螺合する雄ねじ部41の後端に本体11の後端面13の全面又は一部を覆う大きさの略円板フランジ状のキャップ42が連設されている。雄ねじ部41のキャップ42連設面からの長さは、ピン30を椎体L1、L2内に差込む長さに対応したピン30押し込みストロークに対応し、押圧ねじ40を雌ねじ16に前記ストローク螺入させたときキャップ42連設面が本体11の後端面13面に当接した状態となるように設定することが望ましい。また、キャップ42の大きさは、必要に応じて椎体L1、L2間を覆うような大きさとすることもできる。押圧ねじ40の材質としては、本体11と同様に、医療等級のSUS、Ti、多孔性タンタル複合材料等の多孔性材料などがあり、特に強度及び軽量な点からはTiが、骨の内部成長及び血管新生の促進性からは多孔性タンタル複合材料などが好適である。 As shown in FIGS. 8 and 9, the pressing screw 40 is a substantially disc flange having a size that covers the whole or part of the rear end surface 13 of the main body 11 at the rear end of the male screw portion 41 that is screwed into the female screw 16 of the main body 11. A cap 42 is continuously provided. The length of the male screw portion 41 from the surface where the cap 42 is provided corresponds to the pin 30 pressing stroke corresponding to the length of inserting the pin 30 into the vertebral bodies L1 and L2, and the pressing screw 40 is connected to the female screw 16 with the stroke screw. It is desirable to set so that the continuous surface of the cap 42 is in contact with the rear end surface 13 of the main body 11 when it is inserted. Further, the size of the cap 42 can be set so as to cover between the vertebral bodies L1 and L2 as necessary. As the material of the pressing screw 40, there are porous materials such as medical grade SUS, Ti, porous tantalum composite material, etc., as in the case of the main body 11. Especially, Ti is a bone ingrowth in terms of strength and light weight. From the viewpoint of promoting angiogenesis, a porous tantalum composite material or the like is preferable.
 キャップ42の後端面には、前記移植ドライバー又は後述の押圧ねじドライバーの先端係合部が係合する後端係合部として例えば、図10に示すように、十字溝44が形成されている。後端係合部44は、十字溝に代えていずれも図示しない移植ドライバー又は押圧ねじドライバーの例えば六角レンチ状に形成された先端係合部が係合する六角形穴を穿設してもよい。 For example, as shown in FIG. 10, a cross groove 44 is formed on the rear end surface of the cap 42 as a rear end engaging portion that engages with a tip engaging portion of the transplant driver or a press screw driver described later. The rear end engaging portion 44 may be formed with a hexagonal hole that engages with a distal end engaging portion formed in, for example, a hexagon wrench shape of a transplant driver or a pressure screw driver (not shown) instead of the cross groove. .
 図27は本発明の一実施形態の椎体間固定外科手術用椎体間スペース保持装置70の概念を示す縦断面図(上半部断面)、図28は図27の椎体間スペース保持装置70の平面図(上半部断面)、図29は図27のU-U矢視図である。 FIG. 27 is a longitudinal sectional view (upper half section) showing a concept of an interbody space holding device 70 for interbody fusion surgery according to an embodiment of the present invention, and FIG. 28 is an interbody space holding device of FIG. 70 is a plan view (upper half section), and FIG. 29 is a view taken in the direction of arrows U-U in FIG.
 本発明の一実施形態の椎体間スペース保持装置70は、後端に把持部72が設けられ、生体腹部MN1側に設けられた内視鏡用腹腔部Ma内のカニューレK(図1参照)を介して椎体L1、L2の前面近傍まで挿入される中空長尺の第1のシャフト部71、及び第1のシャフト部71の先端部71aに軸方向に沿って延設され、隣接する椎体L1、L2の左右両側面をそれぞれ挟持し固定する固定爪74bが先端に連接されて椎体L1、L2の直交面内で開閉可能な少なくとも各1対のクランプアーム74、74を有する保持装置本体70aと、第1のシャフト部71に前進/後退自在に外嵌され、後端に把持部77が設けられた中空長尺の第2のシャフト部76からなり、前進又は後退することにより各1対のクランプアーム74、74を縮径方向に閉じ又は拡径方向に開くクランプアーム開閉管70bと、からなる。保持装置本体70aとクランプアーム開閉管70bとから椎体クランプ機構を構成している。 An intervertebral body space holding device 70 according to an embodiment of the present invention includes a cannula K in an abdominal part Ma for endoscope provided on a living body abdominal part MN1 side with a grip 72 at a rear end (see FIG. 1). The hollow long first shaft portion 71 inserted to the vicinity of the front surface of the vertebral bodies L1 and L2 via the vertebral body and the distal end portion 71a of the first shaft portion 71 are extended along the axial direction and are adjacent to the vertebrae. A holding device having at least one pair of clamp arms 74 and 74 that can be opened and closed in the orthogonal planes of the vertebral bodies L1 and L2 with fixing claws 74b that clamp and fix the left and right side surfaces of the bodies L1 and L2 respectively. It consists of a main body 70a and a hollow long second shaft portion 76 which is fitted to the first shaft portion 71 so as to be movable forward / backward and provided with a gripping portion 77 at the rear end. A pair of clamp arms 74, 74 A clamp arm closing pipe 70b open to closed or expanded direction direction of reducing the diameter, made of. A vertebral body clamping mechanism is constituted by the holding device main body 70a and the clamp arm opening / closing tube 70b.
 この実施形態の保持装置本体70aは、図28に示すように、先端に各固定爪74bが連設され、後端部が第1のシャフト部71の先端部71aに連設され、フリー状態では固定爪74bをそれぞれ椎体L1、L2の直交面内で拡径して開くように屈曲されて弾支する弾性支持部74aを有する各1対のクランプアーム74、74を備える。 As shown in FIG. 28, the holding device main body 70a of this embodiment has the fixed claws 74b connected to the tip, the rear end connected to the tip 71a of the first shaft portion 71, and in the free state. A pair of clamp arms 74 and 74 each having an elastic support portion 74a that is bent and elastically supported so as to expand and open the fixing claws 74b in the orthogonal planes of the vertebral bodies L1 and L2, respectively.
 そして、クランプアーム開閉管70bは、第2のシャフト部76の先端部76aが前進して弾性支持部74aを外側から押圧することにより各1対のクランプアーム74、74を2点鎖線で示す縮径方向に閉じ、その先端部76aが弾性支持部74aから後退することにより各1対のクランプアーム74、74を2点鎖線で示す拡径方向に開く。各1対のクランプアーム74、74は、第2のシャフト部76の先端部76aのC1軸方向の位置がX1(全閉位置)のとき最小に閉じ、X2(椎体把持/固定位置)のとき椎体L1、L2の左右側面を把持/固定し、X3(全開位置)のとき最大に開く。 The clamp arm opening / closing pipe 70b is a contraction of the pair of clamp arms 74, 74 indicated by a two-dot chain line by the distal end portion 76a of the second shaft portion 76 moving forward and pressing the elastic support portion 74a from the outside. The pair of clamp arms 74 and 74 are opened in a diameter increasing direction indicated by a two-dot chain line by closing in the radial direction and retreating the distal end portion 76a from the elastic support portion 74a. Each of the pair of clamp arms 74, 74 is closed to the minimum when the position of the distal end portion 76a of the second shaft portion 76 in the C1 axis direction is X1 (fully closed position), and is X2 (vertebral body grasping / fixing position). Sometimes the left and right lateral surfaces of the vertebral bodies L1 and L2 are gripped / fixed, and open to the maximum at X3 (fully open position).
 固定爪74bの椎体挟持面には、椎体L1、L2の左右側面に突刺可能な複数の尖鋭突起74cを有する。 The vertebral body clamping surface of the fixed claw 74b has a plurality of sharp protrusions 74c that can be pierced on the left and right side surfaces of the vertebral bodies L1 and L2.
 また、この実施例の保持装置本体70aは、第1のシャフト部71の先端部71aに椎体L1、L2の外径より僅かに狭い間隔で椎体間スペースMに向かい軸方向に沿って対向状態で延設され、先端部から椎間板スペースM内に挿入されることにより隣接する椎体L1、L2を適正な間隔に修正して保持するような外形形状に形成された少なくとも1対のスペーサー73、73をさらに備える。1対のスペーサー73、73と各1対のクランプアーム74、74とはその主軸が略90°ずれた各平面内に設けられる。 Further, the holding device body 70a of this embodiment is opposed to the intervertebral space M along the axial direction at a slightly narrower distance than the outer diameter of the vertebral bodies L1 and L2 to the distal end portion 71a of the first shaft portion 71. At least one pair of spacers 73 formed in an outer shape that extends in a state and is inserted into the intervertebral disc space M from the distal end portion so that the adjacent vertebral bodies L1 and L2 are corrected and held at appropriate intervals. , 73 are further provided. The pair of spacers 73 and 73 and the pair of clamp arms 74 and 74 are provided in respective planes whose main axes are shifted by approximately 90 °.
 こような、保持装置本体70aの構成により、構造及び操作が簡易化され、1対のスペーサー73、73が先端から椎間板スペースM内に挿入されることにより隣接する椎体L1、L2を適正な間隔に修正して保持するとともに、各1対のクランプアーム74、74の複数の尖鋭突起74cを有する固定爪74bにより隣接する椎体L1、L2の左右両側面をそれぞれ挟持し固定することから、椎体間固定外科手術における隣接する椎体L1、L2の適正な間隔修正及び信頼性の高い固定/保持が同時に短時間で行うことができる。これにより、従来の椎体間固定外科手術に比べて手術時間が短縮できるため、患者や医者を含む医療スタッフの肉体及び精神的負担、患者の手術侵襲さらには経済的負担をさらに軽減することができる。 Such a configuration of the holding device main body 70a simplifies the structure and operation, and the pair of spacers 73 and 73 are inserted into the intervertebral disc space M from the distal end, so that the adjacent vertebral bodies L1 and L2 are properly connected. Since the distance between the left and right side surfaces of the adjacent vertebral bodies L1 and L2 is held and fixed by the fixing claws 74b having a plurality of sharp protrusions 74c of each pair of clamp arms 74 and 74, respectively, while being corrected and held at intervals. In the interbody fusion surgery, it is possible to correct the distance between adjacent vertebral bodies L1 and L2 and to perform reliable fixation / retention simultaneously in a short time. As a result, the operation time can be shortened compared to the conventional interbody fusion surgery, so that the physical and mental burdens of medical staff including patients and doctors, the surgical invasion of patients, and the economic burden can be further reduced. it can.
 図30は本発明の変形実施形態の椎体間固定外科手術用椎体間スペース保持装置70´の概念を示す平面図(上半部断面)、図31は図30の椎体間スペース保持装置70´の縦断面図(上半部断面)、図32は図31のV-V矢視図である。この形態における前記一実施形態と同様な機能を有する構成部材には、若干寸法形状が異なっても記述を平易化するため同一の符号及び記号を付してある。 30 is a plan view (upper half section) showing a concept of an intervertebral body space holding device 70 ′ for interbody fusion surgery according to a modified embodiment of the present invention, and FIG. 31 is an interbody space holding device of FIG. 70 'is a longitudinal sectional view (upper half section), and FIG. 32 is a view taken along arrow VV of FIG. In this embodiment, components having the same functions as those of the above-described embodiment are given the same reference numerals and symbols in order to simplify the description even if the dimensions and shapes are slightly different.
 この変形実施形態の椎体間スペース保持装置70´は、前記一実施形態と同様な第1のシャフト部71、及び第1のシャフト部71の先端部71aに第1の支持軸P1を介して椎体L1、L2の直交面内で揺動自在に重ね合されて枢着され、前記一実施形態と同様な固定爪74bが支持部74´aの先端に連接された各1対のクランプアーム74´、74´を有する保持装置本体70´aと、前記一実施形態と同様な第2のシャフト部76及び各1対のクランプアーム74´、74´の中間部の反重ね合せ面側に第2の支持軸P2、P2を介してそれぞれ一端部が揺動自在に重ねられて枢着されるとともに、その各他端部が第2のシャフト部76の先端部76aに突設されたブラケット78に第3の支持軸P3回りに揺動自在に重ね合されて枢着された各1対のリンク部材79、79を有するクランプアーム開閉管70´bと、からなる。 The interbody space holding device 70 ′ of this modified embodiment is similar to the first shaft portion 71 and the distal end portion 71 a of the first shaft portion 71 similar to that of the above-described one embodiment via the first support shaft P <b> 1. A pair of clamp arms each having a fixed claw 74b that is pivotably overlapped and pivotally mounted in an orthogonal plane of the vertebral bodies L1 and L2, and is connected to the tip of the support portion 74'a. The holding device main body 70'a having 74 'and 74' and the second shaft portion 76 and the intermediate portion of each pair of clamp arms 74 'and 74' on the side opposite to the overlapping surface as in the above embodiment Brackets in which one end portions are pivotably overlapped and pivotally mounted via the second support shafts P2 and P2, and the other end portions project from the tip end portion 76a of the second shaft portion 76. 78 is pivotally overlapped with the third support shaft P3 so as to be swingable. And the clamp arm open tube 70'b having a link member 79, 79 of each pair which is composed of.
 保持装置本体70´a及びクランプアーム開閉管70´bは、椎体クランプ機構を構成している。この変形実施形態の椎体クランプ機構は、支持部74´aが前記一実施形態の適宜な弾力性を有する弾性支持部74aとは異なり剛性が大きい形状に形成されており、図30に示すように、第2のシャフト部76が前進又は後退することにより各1対のリンク部材79、79を第3の支持軸P3回りに反時計方向又は時計方向に揺動させて各1対のクランプアーム74´、74´を椎体L1、L2の直交面内で第1の支持軸P1を支点としていずれも2点鎖線で示す縮径方向に閉じ又は拡径方向に開くトグル機構を構成している。各1対のクランプアーム74´、74´は、第2のシャフト部76の先端部76aのC1軸方向の位置がX1´(全閉位置)のとき最小に閉じ、X2(椎体把持/固定位置)のとき椎体L1、L2の左右側面を把持/固定し、X3´(全開位置)のとき最大に開く。 The holding device body 70'a and the clamp arm opening / closing tube 70'b constitute a vertebral body clamping mechanism. In the vertebral body clamping mechanism of this modified embodiment, the support portion 74'a is formed in a shape having high rigidity unlike the elastic support portion 74a having appropriate elasticity of the one embodiment, as shown in FIG. Further, as the second shaft portion 76 moves forward or backward, each pair of link members 79, 79 are swung counterclockwise or clockwise around the third support shaft P3 to each pair of clamp arms. The toggle mechanism 74 ′, 74 ′ is closed in the reduced diameter direction indicated by the two-dot chain line or opened in the enlarged diameter direction with the first support axis P1 as a fulcrum within the orthogonal plane of the vertebral bodies L1, L2. . Each pair of clamp arms 74 ′ and 74 ′ is closed to the minimum when the position of the distal end portion 76 a of the second shaft portion 76 in the C1 axis direction is X 1 ′ (fully closed position), and X 2 (vertebral body grasping / fixing) Position), the left and right lateral surfaces of the vertebral bodies L1 and L2 are gripped / fixed, and the X3 '(fully open position) opens to the maximum.
 この変形実施形態の椎体間スペース保持装置70´は、保持装置本体70´a及びクランプアーム開閉管70´bからなる椎体クランプ機構がトグル機構を構成していることから、隣接する椎体L1、L2の左右両側面の挟持/固定力が強大化され、椎体間スペース保持装置の信頼性を一層向上させることができる。 In the interbody space holding device 70 ′ of this modified embodiment, the vertebral body clamping mechanism including the holding device main body 70 ′ a and the clamp arm opening / closing tube 70 ′ b constitutes a toggle mechanism. The clamping / fixing force between the left and right side surfaces of L1 and L2 is increased, and the reliability of the interbody space holding device can be further improved.
 また、この変形実施形態の椎体間スペース保持装置70´も、第1のシャフト部71の先端部71aに前記一実施形態の椎体間スペース保持装置70と同様の、隣接する椎体L1、L2を適正な間隔に修正して保持するような外形形状に形成された少なくとも1対のスペーサー73、73をさらに備える。 Also, the interbody space holding device 70 ′ of this modified embodiment is similar to the adjacent vertebral body L 1, similar to the interbody space holding device 70 of the above embodiment, at the distal end portion 71 a of the first shaft portion 71. It further includes at least one pair of spacers 73 and 73 formed in an outer shape so that L2 is corrected and held at an appropriate interval.
 また、上記一実施形態及び変形実施形態の椎体間スペース保持装置70、70´の第1及び第2のシャフト部71、76は、図29、32に示すように、いずれも例えば略長円形、略楕円形又は略四角形断面あるいは図示しない略円形や略多角形断面など椎体の外形形状/寸法に相応する中空形状に形成される。そして、例えば本体嵌入ドライバーのシャフト部81に比べて第1のシャフト部71が相当大きくなるような場合、第1のシャフト部71内には、挿通される椎体間固定装置10あるいは椎体間固定装置10の本体11を椎体L1、L2間に嵌入するための後述の本体嵌入ドライバーのシャフト部81の挿入案内用として、椎体間固定装置10あるいはシャフト部81の最大外径より例えば2mm程度大きな内径のガイド筒71b(2点鎖線で示す)を必要に応じて設けてもよい。 In addition, as shown in FIGS. 29 and 32, the first and second shaft portions 71 and 76 of the interbody space holding devices 70 and 70 ′ of the one embodiment and the modified embodiment are both substantially oval, for example. And a hollow shape corresponding to the outer shape / size of the vertebral body, such as a substantially elliptical or substantially rectangular cross section, or a substantially circular or substantially polygonal cross section (not shown). For example, when the first shaft portion 71 is considerably larger than the shaft portion 81 of the main body insertion driver, the intervertebral body fixing device 10 or the intervertebral body is inserted into the first shaft portion 71. For insertion guide of a shaft portion 81 of a body insertion driver to be described later for inserting the main body 11 of the fixing device 10 between the vertebral bodies L1 and L2, for example 2 mm from the maximum outer diameter of the interbody fixing device 10 or the shaft portion 81. A guide cylinder 71b (indicated by a two-dot chain line) having a relatively large inner diameter may be provided as necessary.
 また、図27乃至29に示すように、第1のシャフト部71の先端部の左右のクランプアーム74、74部に対応する内面に架け亘る補強板75、75を必要に応じて設けてもよい。この場合、補強板75、75間の距離は、椎体間固定装置10あるいはシャフト部81に干渉しないようにそれらの最大外径より若干例えば少なくとも2mm程度大きく設定される。 In addition, as shown in FIGS. 27 to 29, reinforcing plates 75 and 75 extending over the inner surfaces corresponding to the left and right clamp arms 74 and 74 at the tip of the first shaft portion 71 may be provided as necessary. . In this case, the distance between the reinforcing plates 75 and 75 is set to be slightly larger than, for example, at least about 2 mm from their maximum outer diameter so as not to interfere with the interbody fusion device 10 or the shaft portion 81.
 図33は本発明のさらに別の変形実施形態の椎体間スペース保持装置70´´の概念を示す縦断面図(上半部断面)、図34は図33の椎体間スペース保持装置70´´の平面図(上半部断面)、図35は図34のW-W矢視図である。この形態における前記実施形態と同様な機能を有する構成部材には、若干寸法形状が異なっても記述を平易化するため同一の符号及び記号を付してある。 FIG. 33 is a longitudinal sectional view (upper half section) showing the concept of an interbody space holding device 70 ″ of still another modified embodiment of the present invention, and FIG. 34 is an interbody space holding device 70 ′ of FIG. ′ ′ Plan view (upper half section), FIG. 35 is a view taken along the line WW in FIG. 34. In this embodiment, components having the same functions as those of the embodiment described above are given the same reference numerals and symbols in order to simplify the description even if the dimensions are slightly different.
 この別の変形実施形態の椎体間スペース保持装置70´´は、後端に把持部72が設けられ、生体腹部MN1側に設けられた内視鏡用腹腔部Ma内のカニューレK(図1参照)を介して椎体L1、L2の前面近傍まで挿入される中空長尺の第1のシャフト部71´と、第1のシャフト部71´の外面に軸方向に沿って回転自在に延設され、先端に形成されたねじ部76´aが隣接する椎体L1、L2の一方又は両方の前面部に羅入し固定される長尺固定ねじ部材76´bと、第1のシャフト部71´の先端部71´aに突設され、隣接する椎体L1、L2の一方又は両方の前面部に突刺可能な一つ又は複数の針状突起71cと、を備える。 The intervertebral body space holding device 70 ″ according to another modified embodiment is provided with a grasping portion 72 at the rear end, and a cannula K (see FIG. 1) in the abdominal portion Ma for endoscope provided on the living body abdominal portion MN1 side. A hollow long first shaft portion 71 ′ inserted to the vicinity of the front surface of the vertebral bodies L 1 and L 2 via the reference), and extended on the outer surface of the first shaft portion 71 ′ so as to be rotatable along the axial direction. A long fixed screw member 76'b in which the screw portion 76'a formed at the tip is inserted into and fixed to one or both front surface portions of the adjacent vertebral bodies L1, L2, and the first shaft portion 71. And one or a plurality of needle-like protrusions 71c that can project into one or both front surface portions of the adjacent vertebral bodies L1 and L2.
 長尺固定ねじ部材76´bは、第1のシャフト部71´の外面に立設された後部支持部材75a及び前部支持部材75bの挿通孔75c内に回転自在に挿通され、後端部に図示しないドライバー又はレンチ係合溝あるいは六角型外形を有する頭部76´cを備えている。 The long fixing screw member 76'b is rotatably inserted into the insertion hole 75c of the rear support member 75a and the front support member 75b provided upright on the outer surface of the first shaft portion 71 '. A driver or wrench engaging groove (not shown) or a head portion 76'c having a hexagonal outer shape is provided.
 長尺固定ねじ部材76´b、後部支持部材75a及び前部支持部材75bは椎体固定機構76´を構成し、カニューレK内に挿入された第1のシャフト部71´を後端部又は把持部72を介して押圧して先端部の針状突起71cを隣接する椎体L1、L2の一方又は両方の前面部に突刺した後に、頭部76´cを介して長尺固定ねじ部材76´bを押圧しながら例えば時計回りに回転させて椎体L1、L2の一方又は両方の前面部に羅入し固定する。 The long fixing screw member 76'b, the rear support member 75a, and the front support member 75b constitute a vertebral body fixing mechanism 76 ', and the first shaft portion 71' inserted into the cannula K is held at the rear end portion or gripped. After pressing through the portion 72 to pierce the frontal portion of one or both of the adjacent vertebral bodies L1 and L2 with the needle-like protrusion 71c at the distal end, the elongated fixing screw member 76 ′ is inserted through the head 76′c. While pressing b, it is rotated clockwise, for example, and inserted into and fixed to one or both front portions of the vertebral bodies L1, L2.
 この変形実施形態の椎体間スペース保持装置70´´は、第1のシャフト部71´の外面及び先端部71´aにそれぞれ設けられた椎体固定機構76´及び針状突起71cにより、隣接する椎体L1、L2の一方又は両方の前面部にそれぞれ螺入、突刺して抜け止め効果を伴って固定することから、構造及び操作が簡易であるとともに、その後で椎体間固定装置10を椎体L1、L2間に移植固定する際に比較的大きな外力が負荷される椎体L1、L2が後方又は左右の側方にずれないため椎体間固定外科手術における椎体間スペース保持の信頼性が確保される。 The interbody space holding device 70 ″ of this modified embodiment is adjacent to the vertebral body fixing mechanism 76 ′ and the needle-like protrusion 71 c provided on the outer surface of the first shaft portion 71 ′ and the distal end portion 71 ′, respectively. The vertebral bodies L1 and L2 are fixed to each other by screwing and piercing into the front portions of the vertebral bodies L1 and L2, respectively, so that the structure and operation are simple. Since the vertebral bodies L1 and L2 to which a relatively large external force is applied when transplanted and fixed between the vertebral bodies L1 and L2 are not displaced rearward or left and right, the reliability of intervertebral body space retention in interbody fusion surgery Sex is secured.
 なお、前記把持部72、77は、それぞれカニューレKの外部に順次露出する長さに設定された第1、第2のシャフト部71、71´、76の後端に嵌着されたボス部72a、77a上に立設された少なくとも1対又は複数の取手(ハンドル)状に形成されているが、公知の円筒型などその他任意の把持形状(図示しない)に形成することができる。 The gripping portions 72 and 77 are boss portions 72a fitted to the rear ends of the first and second shaft portions 71, 71 'and 76, which are set to lengths that are sequentially exposed to the outside of the cannula K, respectively. , 77a and at least one handle or a plurality of handles (handles) standing upright, but can be formed in any other gripping shape (not shown) such as a known cylindrical type.
 また、第1、第2のシャフト部71、71´、76の先端部及びその他のクランプ機構、椎体固定機構76´及びスペーサー73、73´等の部材を除くシャフト部の後方部材は、例えば樹脂などの軽量な高分子材料から構成することができる。椎体間スペース保持装置70、70´、70´´は、極力軽量なTiや高分子材料を組み合せて構成するなど全体を軽量化して操作性を向上させることが望ましい。 Further, the rear members of the shaft portion excluding the distal ends of the first and second shaft portions 71, 71 ′, 76 and other clamp mechanisms, the vertebral body fixing mechanism 76 ′, the spacers 73, 73 ′, etc. It can be composed of a lightweight polymer material such as a resin. It is desirable that the interbody space holding devices 70, 70 ′, and 70 ″ are composed of a combination of Ti and polymer materials that are as light as possible to reduce the overall weight and improve operability.
 図36は本発明の一実施形態の本体嵌入ドライバー80の概念を示す縦断面図(上半部断面)、図37は図36のS-S矢視図、図38は本発明の一実施形態の押圧ねじドライバー90の概念を示す側面図、図39は図38のT-T矢視図である。 FIG. 36 is a longitudinal sectional view (upper half section) showing a concept of a main body insertion driver 80 according to an embodiment of the present invention, FIG. 37 is a view taken along the line SS of FIG. 36, and FIG. 38 is an embodiment of the present invention. FIG. 39 is a view taken along the line TT in FIG. 38.
 一実施形態の本体嵌入ドライバー80は、後端に把持部82が設けられ、前記椎体間スペース保持装置70、70´、70´´の第1のシャフト部71、71´内を介して椎体L1、L2の前面近傍まで挿入される中空長尺のシャフト部81と、シャフト部81の先端に椎体間固定装置10の本体11の後端面13に形成された後端係合部29(図3)に係合する先端係合部83とからなる。 In one embodiment, the body insertion driver 80 is provided with a gripping portion 82 at the rear end, and the vertebrae are interposed through the first shaft portions 71 and 71 ′ of the interbody space holding devices 70, 70 ′ and 70 ″. A hollow long shaft portion 81 inserted to the vicinity of the front surfaces of the bodies L1 and L2, and a rear end engaging portion 29 (formed on the rear end surface 13 of the body 11 of the interbody fusion device 10 at the distal end of the shaft portion 81) 3) and a tip engaging portion 83 that engages.
 把持部82は、前記椎体間スペース保持装置70、70´、70´´の第1のシャフト部71、71´後端の外部に露出する長さに設定されたシャフト部81の後端に嵌着されたボス部82a上に立設された少なくとも1対又は複数の取手(ハンドル)状に形成されている。 The gripping part 82 is attached to the rear end of the shaft part 81 set to a length exposed to the outside of the rear end of the first shaft parts 71, 71 ′ of the interbody space holding devices 70, 70 ′, 70 ″. It is formed in the shape of at least one pair or a plurality of handles (handles) standing on the fitted boss portion 82a.
 先端係合部83は、本体11の部分円弧状の後端係合部29(図3)に嵌入して係合する複数の部分円弧形の爪状に形成されており、その爪の先端部は角部がカットされるなど後端係合部29に嵌入し易い形状となっている。なお、先端係合部83は、後端係合部29の任意の形状に適合する形状に形成される。 The front end engaging portion 83 is formed in a plurality of partial arcuate claw shapes that are engaged with and engaged with the partial arc-shaped rear end engaging portion 29 (FIG. 3) of the main body 11, and the front end of the nail The portion has a shape that can be easily fitted into the rear end engaging portion 29, such as a corner portion being cut. The front end engaging portion 83 is formed in a shape that matches the arbitrary shape of the rear end engaging portion 29.
 先端係合部83はSUSやTiなどの硬質の金属製で、シャフト部81は例えば樹脂などの軽量な高分子材料から構成することができる。本体嵌入ドライバー80は、極力軽量なTiや高分子材料を組み合せて構成するなど全体を軽量化して操作性を向上させることが望ましい。 The tip engaging portion 83 is made of a hard metal such as SUS or Ti, and the shaft portion 81 can be made of a light polymer material such as a resin. It is desirable that the main body insertion driver 80 is lightened as a whole, for example, to be constructed by combining Ti and polymer materials that are as light as possible to improve operability.
 押圧ねじドライバー90は、後端に把持部92が設けられ、本体嵌入ドライバー80のシャフト部81内を介して椎体L1、L2の前面近傍まで挿入される長尺のシャフト部91と、シャフト部91の先端に押圧ねじ40のキャップ42の後端部に形成された後端係合部44(図10)に係合する先端係合部93とからなる。 The pressing screw driver 90 is provided with a grip portion 92 at the rear end, and a long shaft portion 91 inserted into the vicinity of the front surface of the vertebral bodies L1 and L2 through the shaft portion 81 of the main body insertion driver 80, and the shaft portion The front end 91 includes a front end engaging portion 93 that engages with a rear end engaging portion 44 (FIG. 10) formed at the rear end portion of the cap 42 of the pressing screw 40.
 把持部92は、本体嵌入ドライバー80後端の外部に露出する長さに設定されたシャフト部91の後端に嵌着されたボス部92a上に立設された少なくとも1対又は複数の取手(ハンドル)状に形成されている。すなわち、押圧ねじドライバー90は、図1に示すように、椎体間固定装置10の椎体L1、L2間への固定完了状態において本体嵌入ドライバー80の後端面より外側に露出して把持部92を把持できる十分な長さを有する。 The grip portion 92 is at least one pair or a plurality of handles (e.g., standing on a boss portion 92a fitted to the rear end of the shaft portion 91 set to a length exposed to the outside of the rear end of the main body insertion driver 80. It is formed in a handle shape. That is, as shown in FIG. 1, the pressing screw driver 90 is exposed to the outside from the rear end surface of the main body insertion driver 80 when the intervertebral body fixing device 10 is fixed between the vertebral bodies L1 and L2, and is held by the grip portion 92. It has a sufficient length that can be gripped.
 先端係合部93の先端部93aは、押圧ねじ40の後端係合部44(図10)に係合する例えばプラスドライバ状に形成されている。なお、後端係合部44が十字溝に代えて図示しない例えば六角形穴に形成される場合は、先端部93aはその六角形穴に係合する六角レンチ状に形状されるなど、後端係合部44の任意の形状に適合する形状(図示しない)に形成される。 The front end portion 93a of the front end engaging portion 93 is formed, for example, in the shape of a plus driver that engages with the rear end engaging portion 44 (FIG. 10) of the pressing screw 40. When the rear end engaging portion 44 is formed in a hexagonal hole (not shown) instead of the cross groove, the front end 93a is shaped like a hexagon wrench that engages with the hexagonal hole. It is formed in a shape (not shown) that fits any shape of the engaging portion 44.
 先端係合部93はSUSやTiなどの硬質の金属製で、シャフト部91は例えば樹脂などの軽量な高分子材料から構成することができる。押圧ねじドライバー90は、シャフト部91を中空状に形成するなども含めて全体を軽量化して操作性を向上させることが望ましい。 The tip engaging portion 93 is made of a hard metal such as SUS or Ti, and the shaft portion 91 can be made of a light polymer material such as a resin. It is desirable that the pressure screw driver 90 is lightened as a whole including the shaft portion 91 formed in a hollow shape to improve operability.
 なお、前記把持部82、92は、公知の円筒型などその他任意の把持形状(図示しない)に形成することができる。 The gripping portions 82 and 92 can be formed in any other gripping shape (not shown) such as a known cylindrical shape.
 ここで、前記変形実施形態の椎体間スペース保持装置70´´を適用した変形実施形態の椎体間固定外科手術システムの概念縦断面図(主要部断面)を図40に示す。 Here, FIG. 40 shows a conceptual longitudinal cross-sectional view (cross-section of the main part) of the interbody fusion surgery system of the modified embodiment to which the interbody space holding device 70 ″ of the modified embodiment is applied.
 次に、図1、8、9、27~29、36~39、41~43等を参照し、一実施形態の椎体間固定装置10を、腹部MN1側から脊椎の前面まで形成された内視鏡用腹腔部Ma内のカニューレKを介していずれも図示しない内視鏡(又は腹腔鏡)あるいは前記カプセル内視鏡で観察しながら椎体間スペース保持装置70、本体嵌入ドライバー80及び押圧ねじドライバー90を用い、椎体L1、L2の間の椎間板M部に嵌入し椎体L1、L2間を固定する椎体間固定外科手術方法について、その主要な特徴となる部分を説明する。 Next, referring to FIGS. 1, 8, 9, 27 to 29, 36 to 39, 41 to 43, etc., the interbody fusion device 10 according to one embodiment is formed from the abdominal MN1 side to the front surface of the spine. While observing with an endoscope (or a laparoscope) (not shown) or the capsule endoscope through a cannula K in the abdominal cavity Ma for endoscope, the interbody space holding device 70, the body insertion driver 80, and a pressing screw An intervertebral body fixing surgical method that uses a screwdriver 90 to fit into the intervertebral disc M between the vertebral bodies L1 and L2 and fixes the vertebral bodies L1 and L2 will be described as a main feature.
 手術の前に、患者の最適な椎体固定装置10の寸法及び望ましい伸延が評価決定された後、図41(a)に示すように、患者を伸延及び椎体(椎骨)の整列修正が同時にできる脊柱手術台Bd上に上向きに寝かせて脚をく字状に屈曲させるいわゆる砕石位をとった状態で専用の足代に載せ、肩が頭側に下がらないように腕及び脚部を含む人体MNを固定する。 Prior to surgery, after the patient's optimal vertebral body fixation device 10 dimensions and desired distraction have been evaluated, the patient is distracted and the vertebral body (vertebral) alignment corrected simultaneously as shown in FIG. 41 (a). Human body MN including arms and legs so that the shoulder is not lowered to the head side in a so-called crushed position where the legs are bent upwardly on the spinal table Bd To fix.
 引続き、図41(b)に示すように、脊柱手術台Bdを傾け、足部を上げて頭部を下げる状態いわゆる頭部低位・腰部高位のトレンデレンブルグ状態にし、以下の手術を開始する。 Subsequently, as shown in FIG. 41 (b), the spinal table Bd is tilted, the foot is raised and the head is lowered, so that the head is lowered and the waist is in the Trendelenburg state, and the following operation is started.
 このトレンデレンブルグ状態で、図42に示すように、腹部MN1の所定の位置に例えば電気メスにより数mm程度の切開創Mfを適宜複数ヶ所設けて腹腔鏡用ポートMa、Mb、Mc、Md、Me等を設定し、そこから対象となる前記椎体L1、L2に対応する手術場所を観察するために例えばアクセスニードルなどの穿刺針を通して腹腔内にCO2などの不活性ガスである気腹ガスを注入する。このように、腹部MN1側から気腹ガスを腹腔内に注入して腸部を下腹部側に押し遣り、内視鏡(又は腹腔鏡)を介して椎体L1、L2近傍の視界を確保する。ポートMaは、前記椎体間固定装置10を挿入するための主要な腹腔鏡用ポートなるもので、前記椎体L1、L2間のほぼ中央部を目指して配置される。ポートMbは、腹部MN1の中心軸上で例えば臍から数mm~10cm程度頭部寄りに配置される。腹壁は、椎体L1、L2部とは反対の上腹部の脈管の側方に配置される。 In this Trendelenburg state, as shown in FIG. 42, laparoscopic ports Ma, Mb, Mc, Md, and a plurality of incision wounds Mf of about several millimeters are provided at predetermined positions of the abdominal part MN1, for example, with an electric knife. In order to observe the surgical site corresponding to the target vertebral bodies L1 and L2 from there, for example, Me or the like, an insufflation gas such as CO2 is supplied into the abdominal cavity through a puncture needle such as an access needle. inject. In this way, pneumoperitoneum gas is injected into the abdominal cavity from the abdominal part MN1 side, the intestine part is pushed to the lower abdominal part side, and a field of view near the vertebral bodies L1 and L2 is secured through the endoscope (or laparoscope). . The port Ma is a main laparoscopic port for inserting the interbody fusion device 10 and is arranged so as to aim at a substantially central portion between the vertebral bodies L1 and L2. The port Mb is disposed on the central axis of the abdominal part MN1, for example, a few millimeters to 10 cm from the navel near the head. The abdominal wall is disposed on the side of the upper abdominal vessel opposite to the vertebral bodies L1 and L2.
 ポートMc、Mdは、ポートMbの左右側に互いに対向するように僅かにずらして配置される。ポートMc、Mdを通して図示しない適宜なリトラクタ(鉗子)を挿入し、対象となる椎体部の周囲から適宜内臓物を引き離す処置などが行われる。 The ports Mc and Md are arranged slightly shifted so as to face each other on the left and right sides of the port Mb. An appropriate retractor (forceps) (not shown) is inserted through the ports Mc and Md, and a treatment for appropriately separating the internal organs from the periphery of the target vertebral body is performed.
 このようにして、腹部MN1側に設けられた複数個所のポートMa、Mb、Mc、Md、Meから内視鏡(又は腹腔鏡)を介して椎体L1、L2に隣接する腹部側及び左右側面のいずれも図示しない硬膜包及び横断神経根などの骨辺縁物を脇に押し遣るなどの事前処置を施す(事前処置工程)。 In this way, the abdominal side and the left and right side surfaces adjacent to the vertebral bodies L1 and L2 from the ports Ma, Mb, Mc, Md, and Me provided on the abdominal part MN1 side via the endoscope (or laparoscope) In either case, a pretreatment such as pushing a bone margin such as a dural capsule and a transverse nerve root (not shown) to the side is performed (pretreatment step).
 この際、図43に示すように、例えばバーサステップあるいはバーサポートなどの処置用トロカールスリーブTrがポートMa部内に配置される。トロカールスリーブTrの外筒である中空状のカニューレ(又はパワーシールドスリーブ)K内には、穿刺針や穿刺針が抜き外された後に後述の各種処置具Tpが脊柱(脊椎)L部まで挿入される。 At this time, as shown in FIG. 43, for example, a treatment trocar sleeve Tr such as a verse step or a bar support is disposed in the port Ma portion. In the hollow cannula (or power shield sleeve) K which is the outer cylinder of the trocar sleeve Tr, after the puncture needle and the puncture needle are removed, various treatment tools Tp described later are inserted up to the spinal column (spine) L portion. The
 次いで、腹部MN1側に設けられた内視鏡用ポートMa部内に挿入されたカニューレKを介して、図27、28に示すように、椎体L1、L2の前面近傍まで各1対のクランプアーム74、74を閉じた状態の椎体間スペース保持装置70を挿入し、1対のスペーサー73、73を先端から椎間板スペースM内に挿入して隣接する椎体L1、L2を適正な間隔に修正して保持すると同時に、各1対のクランプアーム74、74を開き固定爪74bにより隣接する椎体L1、L2の左右両側面をそれぞれ挟持するように再度閉じて複数の尖鋭突起74cを介して(突刺し)固定する(椎体間スペース保持工程)。このとき、各1対のクランプアーム74、74の開閉操作は、前記したように、クランプアーム開閉管70bを後退又は前進させることにより行う。 Next, as shown in FIGS. 27 and 28, a pair of clamp arms to the vicinity of the front surfaces of the vertebral bodies L1 and L2 through a cannula K inserted into the endoscope port Ma provided on the abdominal part MN1 side. The intervertebral space holding device 70 with 74 and 74 closed is inserted, and a pair of spacers 73 and 73 are inserted into the intervertebral disc space M from the tip to correct the adjacent vertebral bodies L1 and L2 to an appropriate interval. At the same time, the pair of clamp arms 74 and 74 are opened and closed again so as to sandwich the left and right side surfaces of the adjacent vertebral bodies L1 and L2 by the fixing claws 74b, respectively, via a plurality of sharp protrusions 74c ( Piercing) and fixing (interbody space holding process). At this time, the opening / closing operation of each pair of clamp arms 74, 74 is performed by moving the clamp arm opening / closing pipe 70b backward or forward as described above.
 次に、いずれも図示しないが、腹部MN1側から椎体間スペース保持装置70の第1のシャフト部71内に挿入した内視鏡(又は腹腔鏡)を用いて移植ドライバーのドリル又は中空の管状カッター(穿孔器)により椎体L1、L2の間の椎間板スペースM部に椎体固定装置10の本体11の外径より僅かに細い外径の下穴を適宜深さまで穿設する(下穴穿設工程)。 Next, although not shown in the figure, a transplant driver drill or a hollow tubular tube is used by using an endoscope (or a laparoscope) inserted into the first shaft portion 71 of the interbody space holding device 70 from the abdominal part MN1 side. With a cutter (perforator), a pilot hole having an outer diameter slightly narrower than the outer diameter of the main body 11 of the vertebral body fixing device 10 is drilled to an appropriate depth in the intervertebral disc space M between the vertebral bodies L1, L2. Installation process).
 前記下穴穿設工程後、本体嵌入ドライバー80の先端係合部83に本体11の後端係合部29を係合した状態で腹部MN1側から椎体間スペース保持装置70の第1のシャフト部71内に挿入し、本体11を押圧及び回転させて椎間板スペースM部の前記下孔の所定位置までねじ込み嵌入させて固定する(本体嵌入工程)。このとき本体11は、図8に示すように、雄ねじ14、15の外面頭頂部が椎体L1、L2の対向面L1a、L2a部に食い込み係合して螺入される。 After the pilot hole drilling step, the first shaft of the interbody space holding device 70 from the abdomen MN1 side with the rear end engaging portion 29 of the main body 11 engaged with the front end engaging portion 83 of the main body insertion driver 80. It is inserted into the portion 71, and the main body 11 is pressed and rotated to be screwed and fixed to a predetermined position of the lower hole in the intervertebral disc space M (main body inserting step). At this time, as shown in FIG. 8, the main body 11 is screwed into the outer surface tops of the male screws 14 and 15 by biting into and engaging with the opposing surfaces L1a and L2a of the vertebral bodies L1 and L2.
 次いで、図8、9に示すように、押圧ねじドライバー90の先端係合部93に押圧ねじ40の後端係合部44を係合した状態で腹部MN1側から本体嵌入ドライバー80のシャフト部81内に挿入し、押圧ねじ40を椎体L1、L2間に嵌入し固定した本体11の後端面13の雌ねじ部16に挿入し押圧しながら回転してねじ込み、雄ねじ部41の先端43面で1対のピン30、30の後端31、31面を押圧してピン30、30の先端32、32側をそれぞれ傾斜角Θ1、Θ2のガイド孔17、18に沿って案内し順次屈曲させながら対向面L1a、L2a部から椎体L1、L2内に傾斜して差込み固定する(ピン差込み固定工程)。このとき、本体嵌入ドライバー80の把持部82を回転しないように別途いずれも図示しない人手又は機械的回転拘束手段により十分押圧して保持しながら、押圧ねじ40をキャップ42連設面が本体11の後端面13に当接する所定トロークまで雌ねじ16内に螺入する。 Next, as shown in FIGS. 8 and 9, the shaft portion 81 of the body insertion driver 80 from the abdomen MN <b> 1 side in a state where the rear end engagement portion 44 of the press screw 40 is engaged with the front end engagement portion 93 of the press screw driver 90. It is inserted into the internal threaded portion 16 of the rear end surface 13 of the main body 11 which is inserted and fixed between the vertebral bodies L1 and L2, and is rotated and screwed in while pressing, and 1 at the tip 43 surface of the male threaded portion 41. The rear surfaces 31, 31 of the pair of pins 30, 30 are pressed so that the tips 32, 32 side of the pins 30, 30 are guided along the guide holes 17, 18 of the inclination angles Θ1, Θ2, respectively, and are bent sequentially. The surfaces L1a and L2a are inclined and inserted into the vertebral bodies L1 and L2 (pin insertion and fixing step). At this time, the press screw 40 is held by the cap 42 continuous surface of the main body 11 while being sufficiently pressed and held by hand or mechanical rotation restraining means (not shown) so as not to rotate the gripping portion 82 of the main body insertion driver 80. Screw into the internal thread 16 up to a predetermined trowel contacting the rear end face 13.
 このようにキャップ42は、最終的に本体11の後端面13に当接することにより、本体11内部への押圧ねじ40の所定ストロークのねじ込み代が規定されるとともに押圧ねじ40の逆回転摩擦力がアップするため押圧ねじ40の逆回転防止効果及びこれによるピン30の抜け止め効果を有する。 In this way, the cap 42 finally comes into contact with the rear end surface 13 of the main body 11, thereby defining the screwing allowance of the pressing screw 40 into the main body 11 for a predetermined stroke and the reverse rotational frictional force of the pressing screw 40. Therefore, it has the effect of preventing the reverse rotation of the pressing screw 40 and the effect of preventing the pin 30 from coming off.
 以上説明したように、椎体間固定装置10は椎体L1、L2間の適正な間隔に適合する外形を有する小型であり、本体11を椎体L1、L2間に螺入した後に押圧ねじ40を本体11の雌ねじ16にねじ込むだけで押圧されたピン30の先端32からガイド孔17、18に沿って屈曲され椎体L1、L2内に差込み固定される簡潔な構成であることから、腹腔鏡を併用して全て主軸C1方向からの一軸回りのねじ込み操作のみで容易に短時間で椎体間固定処置を行うことができる。 As described above, the interbody fusion device 10 is a small size having an outer shape adapted to an appropriate distance between the vertebral bodies L1 and L2, and after the main body 11 is screwed between the vertebral bodies L1 and L2, the pressing screw 40 is used. Is simply bent into the female screw 16 of the main body 11 and is bent along the guide holes 17 and 18 from the tip 32 of the pin 30 that is pressed, and is inserted into the vertebral bodies L1 and L2 and fixed. Thus, the interbody fusion treatment can be easily performed in a short time only by screwing around one axis from the direction of the main axis C1.
 このようにして、本発明の椎体間固定外科手術システム、外科手術方法及び椎体間スペース保持装置は、従来の椎体間固定外科手術に比べて手術規模が大幅に縮小化されるとともに手術時間及び回復期間とも大幅に短縮できるため、患者や医者を含む医療スタッフの肉体及び精神的負担、患者の手術侵襲さらには経済的負担を著しく軽減することができる。そして、椎体L1、L2内に差込まれ固定されたピン30により本体11の適正位置からの後退や回転を防止することができ、椎体間固定の信頼性が確保されるとともに、椎体間固定構造及び操作が大幅に簡潔化及びコンパクト化され、操作性及び経済性とも一層有利となる。 As described above, the interbody fusion surgery system, the surgical method, and the interbody space holding device of the present invention are greatly reduced in operation scale as compared with the conventional interbody fusion surgery, and operated. Since both the time and the recovery period can be greatly shortened, the physical and mental burdens of medical staff including patients and doctors, surgical invasion of patients, and economic burdens can be significantly reduced. Then, the pin 30 inserted and fixed in the vertebral bodies L1 and L2 can prevent the body 11 from retreating or rotating from the proper position, and the intervertebral body fixing reliability is ensured. The intermediate fixing structure and operation are greatly simplified and compact, and the operability and economy are more advantageous.
 図11は本発明の別の実施形態(実施例2)による椎体間固定装置10aの椎体L1、L2間への固定完了状態を示す縦断面図(主要部断面)、図12は図11のF-F矢視図である。 FIG. 11 is a longitudinal cross-sectional view (main part cross-section) showing the state of fixation between the vertebral bodies L1 and L2 of the interbody fusion device 10a according to another embodiment (Example 2) of the present invention, and FIG. FIG.
 実施例2の椎体間固定装置10aは、実施例1の椎体間固定装置10に対して、押圧ねじ50に遊嵌され隣接する椎体L1、L2の前面部にかけ亘り係合し固定されることにより椎体L1、L2間の固定を補強するための固定補強具60が追加されている点が異なるだけで、他は実施例1と全く同様の構成である。従ってここで、実施例1と同様な機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してある。 The interbody fusion device 10a of the second embodiment is engaged with and fixed to the front surface portions of the adjacent vertebral bodies L1 and L2 loosely fitted to the pressing screw 50 with respect to the interbody fusion device 10 of the first embodiment. Thus, the configuration is exactly the same as that of the first embodiment except that a fixing reinforcing tool 60 for reinforcing fixation between the vertebral bodies L1 and L2 is added. Accordingly, here, the same reference numerals are given to the constituent members having the same functions as those in the first embodiment even if the shapes are slightly different.
 押圧ねじ50は、実施例1の椎体間固定装置10における押圧ねじ40と全く同様の構成であるが、本体11の雌ねじ16に螺合する雄ねじ部51が押圧ねじ40に比べ固定補強具60が追加される分長くなっている点が異なるだけである。 The pressing screw 50 has the same configuration as that of the pressing screw 40 in the interbody fusion device 10 of the first embodiment, but the male screw portion 51 that is screwed into the female screw 16 of the main body 11 has a fixed reinforcing tool 60 as compared with the pressing screw 40. The only difference is that it is longer by adding.
 また、押圧ねじ50のキャップ52の後端面には、押圧ねじドライバー90の先端係合部93が係合するための例えば、図12に示すような十字溝54が形成されているが、十字溝54に代えていずれも図示しない六角レンチ状に形成された係合部93が係合する凹溝状の六角形穴を穿設してもよい。 For example, a cross groove 54 as shown in FIG. 12 is formed on the rear end surface of the cap 52 of the press screw 50 so that the tip engagement portion 93 of the press screw driver 90 is engaged. Instead of 54, a hexagonal hole having a concave groove shape with which an engaging portion 93 formed in a hexagonal wrench shape (not shown) may be formed.
 固定補強具60は、押圧ねじ50の雄ねじ部51に遊嵌されるボス61と、それぞれボス61外面に上下軸対称に立設され、押圧ねじのキャップ52部にボス61部後端面が押圧されて先端部が隣接する椎体L1、L2の前面部にそれぞれ係合固定される1対のアーム62、62と、からなる。 The fixed reinforcing member 60 is provided with a boss 61 that is loosely fitted to the male screw portion 51 of the pressing screw 50, and is vertically provided on the outer surface of the boss 61 so as to be vertically symmetrical, and the rear end surface of the boss 61 portion is pressed against the cap 52 portion of the pressing screw. And a pair of arms 62 and 62 that are engaged and fixed to the front portions of the adjacent vertebral bodies L1 and L2, respectively.
 固定補強具60の材質としては、本体11と同様に、医療等級のSUS、Tiなどがあり、特に強度及び軽量な点からはTiが好適である。 As the material of the fixing reinforcing member 60, there are medical grade SUS, Ti, etc., as in the case of the main body 11, and Ti is particularly suitable from the viewpoint of strength and light weight.
 アーム62は、キャップ52側の後端側に設けられ、先端が椎体L1、L2側に略90°屈曲された板状フランジ62a、及び板状フランジ62aに沿ってボス61外面に立設されたウエブ62bからなる横断面略T字形に形成されている。この場合、アーム62先端の先端部は、椎体L1、L2の腹部側側面に喰い込み係合して固定され易いようにテーパ状に先鋭に形成される。 The arm 62 is provided on the rear end side of the cap 52 side, and is erected on the outer surface of the boss 61 along the plate-like flange 62a whose tip is bent by approximately 90 ° toward the vertebral bodies L1 and L2, and the plate-like flange 62a. The web 62b is formed in a substantially T-shaped cross section. In this case, the distal end portion of the distal end of the arm 62 is formed in a tapered shape so as to be easily engaged with and fixed to the abdominal side surfaces of the vertebral bodies L1 and L2.
 次に、この実施形態の椎体間固定装置10aを腹部MN1側からいずれも図示しない腹腔鏡あるいは前記カプセル内視鏡等で観察しながら椎体間スペース保持装置70、本体嵌入ドライバー80及び押圧ねじドライバー90を用い、椎体L1、L2の間の椎間板M部に嵌入して椎体L1、L2間を固定する椎体間固定外科手術方法について、前記実施例1の椎体間固定装置10における場合と異なる主要な特徴部分を説明する。 Next, while observing the interbody fusion device 10a of this embodiment from the abdominal part MN1 side with a laparoscope (not shown) or the capsule endoscope, the interbody space holding device 70, the body insertion driver 80, and the pressing screw In the interbody fusion device 10 of the first embodiment described above, an interbody fusion surgery method in which the intervertebral body L1 and L2 is fixed by inserting into the intervertebral disc M portion between the vertebral bodies L1 and L2 using the driver 90. Main features different from the case will be described.
 前記実施例1におけると同様な下穴穿設工程の後又は前に、隣接する椎体L1、L2の前面部のそれぞれ対向面L1a、L2aから適宜位置に固定補強具60のアーム62先端部が係合する略T字形の係合溝L1b、L2bを穿設する(固定補強具係合溝穿設工程)。 After or before the pilot hole drilling step similar to that in the first embodiment, the distal end portion of the arm 62 of the fixed reinforcing tool 60 is appropriately positioned from the opposing surfaces L1a and L2a of the front surface portions of the adjacent vertebral bodies L1 and L2. Engage substantially T-shaped engaging grooves L1b and L2b to be engaged (fixed reinforcement engaging groove engaging step).
 次いで、前記実施例1におけると同様な本体嵌入工程に続いて、押圧ねじドライバー90の先端係合部93に固定補強具60のボス61内にねじ部51を挿通した押圧ねじ50の後端係合部54を係合した状態で本体嵌入ドライバー80のシャフト部81内に挿入し、押圧ねじ50を椎体L1、L2間に嵌入し固定した本体11の雌ねじ部16に挿入して押圧しながら回転してねじ込み、雄ねじ部51の先端面53でピン30、30の後端31、31面を押圧してピン30、30の先端32、32側をガイド孔17、18に沿って案内し順次屈曲させながら対向面L1a、L2a部から椎体L1、L2内に傾斜して差込み固定するとともに、押圧ねじ50のキャップ52前端面からの軸方向推進力により固定補強具60のアーム62先端部をそれぞれ椎体L1、L2の前面部の係合溝L1b、L2bに押圧して係合し固定する(ピン差込及び固定補強具固定工程)。このとき、本体嵌入ドライバー80の把持部82を回転しないように別途いずれも図示しない人手又は機械的回転拘束手段によりしっかり押圧して保持しながら、押圧ねじ50をキャップ52連設面が固定補強具60のボス後端面に当接する所定トロークまで雌ねじ16内に螺入する。 Subsequently, following the main body fitting step similar to that in the first embodiment, the rear end engagement of the pressing screw 50 in which the screw portion 51 is inserted into the boss 61 of the fixing reinforcing tool 60 through the tip engaging portion 93 of the pressing screw driver 90. Inserting into the shaft portion 81 of the main body insertion driver 80 with the joint portion 54 engaged, and inserting and pressing the pressing screw 50 into the female screw portion 16 of the main body 11 inserted and fixed between the vertebral bodies L1 and L2. Rotating and screwing, pressing the rear ends 31 and 31 of the pins 30 and 30 with the front end surface 53 of the male screw portion 51 to guide the front ends 32 and 32 of the pins 30 and 30 along the guide holes 17 and 18 and sequentially Inclined and inserted into the vertebral bodies L1 and L2 from the opposing surfaces L1a and L2a while being bent, and the distal end portion of the arm 62 of the fixing reinforcement 60 by the axial propulsive force from the front end surface of the cap 52 of the pressing screw 50 Engaging groove of each front portion of the vertebral body L1, L2 L1b, engaged and fixed to pressing the L2b (pin plug and the fixed brace fixing step). At this time, while the gripping portion 82 of the main body insertion screwdriver 80 is not rotated separately, the pressing screw 50 is held by the cap 52 continuous surface while the pressing screw 50 is firmly pressed and held by hand or mechanical rotation restraining means (not shown). Screw into the internal thread 16 up to a predetermined trowel that contacts the rear end surface of the boss 60.
 すなわち、実施例2における椎体間固定方法は、少なくとも事前処置工程、椎体間スペース保持工程、下穴穿設工程、本体嵌入工程、固定補強具係合溝穿設工程、ピン差込み及び固定補強具固定工程を有する。 That is, the interbody fixing method according to the second embodiment includes at least a pretreatment process, an intervertebral body space holding process, a pilot hole drilling process, a main body insertion process, a fixing reinforcement engaging groove drilling process, pin insertion, and fixing reinforcement. It has a tool fixing process.
 実施例2の椎体間固定装置10aを用いた椎体間固定外科手術システム及び外科手術方法は、前記実施例1と同様な利点を有するのに加えて、押圧ねじ50に遊嵌された固定補強具60の1対のアーム62先端部が押圧ねじ50のキャップ部52にボス61部後端面が押圧されることにより隣接する椎体L1、L2の前面部にそれぞれ係合し固定されることから、簡単な操作で椎体間固定が強固に補強されるため、椎体間固定の信頼性を容易に向上させることができる。また、アーム62に適宜の剛性を持たせることができ、その剛性反力により押圧ねじ50の逆回転摩擦力がアップして保持されるため押圧ねじ50の逆回転防止効果及びこれによるピン30の抜け止め効果を一層向上させることができる。 The interbody fusion surgical system and the surgical method using the interbody fusion device 10a of the second embodiment have the same advantages as those of the first embodiment, and in addition, the fixation is loosely fitted to the pressing screw 50. The distal ends of a pair of arms 62 of the reinforcing tool 60 are engaged with and fixed to the front portions of the adjacent vertebral bodies L1 and L2 by pressing the rear end surface of the boss 61 against the cap portion 52 of the pressing screw 50, respectively. Therefore, since the interbody fusion is strongly reinforced by a simple operation, the reliability of the interbody fusion can be easily improved. In addition, the arm 62 can be provided with appropriate rigidity, and the reverse reaction force of the pressing screw 50 is increased and held by the rigidity reaction force. The retaining effect can be further improved.
 図13は本発明のまた別の実施形態(実施例3)の椎体間固定装置10bの概念を示す縦断面図(主要部断面)、図14は図13のP-P矢視図である。 FIG. 13 is a longitudinal sectional view (main part sectional view) showing a concept of an interbody fusion device 10b of still another embodiment (Example 3) of the present invention, and FIG. 14 is a view taken along the line PP in FIG. .
 実施例3の椎体間固定装置10bは、実施例1の椎体間固定装置10に対して、本体11bの外形が略先細り中空円錐台状に形成されている点が異なるだけで、他は実施例1と全く同様の構成である。従ってここで、実施例1と同様の機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してあり、個々の説明は重複するので省略する。 The interbody fusion device 10b of the third embodiment is different from the interbody fusion device 10 of the first embodiment only in that the outer shape of the main body 11b is substantially tapered and formed into a hollow truncated cone shape. The configuration is exactly the same as in the first embodiment. Therefore, the same reference numerals are given to constituent members having the same functions as those in the first embodiment even if the shapes are slightly different, and the description thereof will be omitted because they are duplicated.
 実施例3の本体11bの外形は、下方の椎体L2の正常な前湾姿勢角度に対応する角度例えば略9°でその長さに沿ってテーパを有する略先細り円錐台形に形成されている。この本体11bの円錐台形テーパ角は、本体11bが前端及び後端の外径に亘り所定の位置に嵌入されたときに隣接する椎体L1、L2が適正な前湾姿勢角度を成すように広がる量を画定することができる。 The outer shape of the main body 11b of Example 3 is formed in a substantially tapered truncated cone shape having a taper along its length at an angle corresponding to the normal anterior bay posture angle of the lower vertebral body L2, for example, approximately 9 °. The frustoconical taper angle of the main body 11b widens so that the adjacent vertebral bodies L1 and L2 form an appropriate front bay posture angle when the main body 11b is fitted in a predetermined position over the outer diameters of the front end and the rear end. A quantity can be defined.
 図15は本発明のまた別の実施形態(実施例4)の椎体間固定装置10cの概念を示す縦断面図(主要部断面)で、図16の(a)は図15の摩擦板55部のG-G矢視断面図、(b)は(a)のH-H矢視断面図である。 FIG. 15 is a longitudinal sectional view (main part sectional view) showing a concept of an interbody fusion device 10c of still another embodiment of the present invention (Example 4), and FIG. 16 (a) is a friction plate 55 of FIG. FIG. 5B is a cross-sectional view taken along the line GG of FIG. 5B, and FIG.
 実施例4の椎体間固定装置10cは、実施例3の椎体間固定装置10bに対して、本体11bの雌ねじ16内に遊嵌収容され、ピン30、30の後端31、31部に当接配置される摩擦板55が追加されている点が異なるだけで、他は実施例3と全く同様の構成である。従ってここで、実施例3と同様の機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してある。 The interbody fusion device 10c according to the fourth embodiment is loosely accommodated in the female screw 16 of the main body 11b with respect to the interbody fusion device 10b according to the third embodiment, and is provided at the rear ends 31 and 31 of the pins 30 and 30. The rest of the configuration is exactly the same as that of the third embodiment, except that a friction plate 55 arranged in contact is added. Accordingly, here, the same reference numerals are given to the structural members having the same functions as those in the third embodiment even if the shapes are slightly different.
 摩擦板55のピン後端31、31部との当接面側には、図16(a)、(b)に示すように、ピン後端31、31部が嵌入する適宜深さの1対のピン固定溝55a、55aが穿設されている。 As shown in FIGS. 16 (a) and 16 (b), the friction plate 55 has a pair of appropriate depths for fitting the pin rear ends 31, 31 on the contact surface side with the pin rear ends 31, 31b. The pin fixing grooves 55a and 55a are formed.
 ピン後端31、31部がピン固定溝55a、55aに嵌入することにより左右、上下方向への移動が拘束されるため、押圧ねじ40又は50(図8~12)により摩擦板55を介してピン後端31、31部が押圧されて先端32、32側が椎体L1、L2内に差込まれる場合、特にピン後端31、31部が本体11bの雌ねじ16部内面との隙間の多い左右方向に横滑りして移動する(逃げる)ことなく、ピン11がスムースに前方に押し込まれガイド孔17、18に沿って椎体L1、L2内に差込まれ易くなる。 Since the rear end portions 31 and 31 of the pins are inserted into the pin fixing grooves 55a and 55a, the movement in the left and right and up and down directions is restrained. When the pin rear ends 31 and 31 are pressed and the tips 32 and 32 are inserted into the vertebral bodies L1 and L2, the left and right sides of the pin rear ends 31 and 31 have a large gap with the inner surface of the female thread 16 portion of the main body 11b. The pin 11 is smoothly pushed forward without slipping in the direction (moving away) and easily inserted into the vertebral bodies L1 and L2 along the guide holes 17 and 18.
 また、ピン後端31、31部の横滑りなどによる移動(逃げ)を拘束するため、ピン固定溝55aを設けなくとも、摩擦板55をピン後端31、31部に溶接又は接着により固着してもよい。 Further, in order to restrain the movement (escape) of the pin rear ends 31 and 31 due to side slipping, the friction plate 55 is fixed to the pin rear ends 31 and 31 by welding or bonding without providing the pin fixing groove 55a. Also good.
 これに対して、前記ピン固定溝55aや固着などのピン後端31、31部の移動拘束手段を用いることなく、摩擦板55を単にピン後端31、31部に当接配置するだけでもよい。いずれにしても、摩擦板55を配置することにより、摩擦板55を介して押圧ねじ40又は50のピン後端31、31部押圧が行われることから、押圧ねじ40又は50とピン後端31、31面側との摩擦力が減少するとともにピン後端31、31面が直接押圧ねじ40又は50の回転力を受けないためピン後端31、31部が本体11bの雌ねじ16部内面との隙間の多い左右方向に横滑りして移動し(逃げ)ようとする力を殆ど受けることなく、押圧ねじ40又は50も小トルクで雌ねじ16内にねじ込まれるとともにピン30がスムースに前方に押し込まれることが可能である。 On the other hand, the friction plate 55 may be simply placed in contact with the pin rear ends 31, 31 without using the pin fixing groove 55a or the movement restraining means of the pin rear ends 31, 31 such as fixing. . In any case, by placing the friction plate 55, the pin rear end 31, 31 part of the pressing screw 40 or 50 is pressed via the friction plate 55, and therefore the pressing screw 40 or 50 and the pin rear end 31 are pressed. , The pin rear end 31, 31 surface is not directly subjected to the rotational force of the pressing screw 40 or 50 and the pin rear end 31, 31 portion is in contact with the inner surface of the female screw 16 portion of the main body 11b. The pressing screw 40 or 50 is screwed into the female screw 16 with a small torque and the pin 30 is smoothly pushed forward without almost receiving the force of sliding (moving away) in the lateral direction with many gaps. Is possible.
 図17は本発明のまた別の実施形態(実施例5)の椎体間固定装置10dの概念を示す縦断面図(主要部断面)、図18は図17のQ-Q矢視図、図19は図17の平面図である。 FIG. 17 is a longitudinal sectional view (main part sectional view) showing the concept of an interbody fusion device 10d according to another embodiment of the present invention (Example 5), and FIG. 18 is a view taken along the line QQ of FIG. 19 is a plan view of FIG.
 実施例5の椎体間固定装置10dは、実施例1の椎体間固定装置10における本体11の外面係合部14が雄ねじ状に形成されているのに対して、本体11dの外面係合部14aが主軸C1に平行な複数のスプライン歯状に形成されている点が異なるだけで、他は実施例1と全く同様の構成である。従ってここで、実施例1と同様の機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してあり、個々の説明は重複するので省略する。 In the interbody fusion device 10d of the fifth embodiment, the outer surface engaging portion 14 of the main body 11 in the interbody fusion device 10 of the first embodiment is formed in a male screw shape, whereas the outer surface engagement of the main body 11d. The configuration is exactly the same as that of the first embodiment except that the portion 14a is formed in a plurality of spline teeth parallel to the main axis C1. Therefore, the same reference numerals are given to constituent members having the same functions as those in the first embodiment even if the shapes are slightly different, and the description thereof will be omitted because they are duplicated.
 この実施例では、外面係合部14aが主軸C1に平行な複数のスプライン歯状に形成されているため、本体11dを押圧するだけで前記実施例1~3における本体11、11bのねじ込むための回転操作を省くことができることから短時間に椎体L1、L2間に嵌入し固定することができ、操作性が向上する。 In this embodiment, since the outer surface engaging portion 14a is formed in a plurality of spline teeth parallel to the main shaft C1, the main bodies 11 and 11b in the first to third embodiments can be screwed only by pressing the main body 11d. Since the rotation operation can be omitted, the vertebral bodies L1 and L2 can be fitted and fixed in a short time, and the operability is improved.
 また、外面係合部14aであるスプライン歯の径方向外面頭頂部及び軸方向先端部は尖鋭刃状に形成されており、本体11dを押圧することにより椎体L1、L2間に容易に嵌入させることができる。 Further, the radial outer surface vertex and axial tip of the spline teeth that are the outer surface engaging portion 14a are formed in a sharp blade shape, and can be easily fitted between the vertebral bodies L1 and L2 by pressing the main body 11d. be able to.
 図20は本発明のまた別の実施形態(実施例6)の椎体間固定装置10eの概念を示す縦断面図(主要部断面)、図21は図20のR-R矢視図、図22は図20の平面図である。 FIG. 20 is a longitudinal sectional view (major section) showing a concept of an interbody fusion device 10e of another embodiment of the present invention (Example 6), and FIG. 21 is a view taken along the line RR of FIG. 22 is a plan view of FIG.
 実施例6の椎体間固定装置10eは、実施例5の椎体間固定装置10dにおける本体11dの外面係合部14bがスプライン歯状に形成されているのに対して、本体11eの外面係合部14cが主軸C1に平行な複数の鋸歯状に形成されている点が異なるだけで、他は実施例1あるいは5等と全く同様の構成である。従ってここで、実施例1あるいは5と同様の機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してあり、個々の説明は重複するので省略する。 In the interbody fusion device 10e of the sixth embodiment, the outer surface engaging portion 14b of the main body 11d in the interbody fusion device 10d of the fifth embodiment is formed in a spline shape, whereas the outer surface engagement of the main body 11e. Except for the point that the joint portion 14c is formed in a plurality of sawtooth shapes parallel to the main axis C1, the rest of the configuration is exactly the same as in the first or fifth embodiment. Therefore, the same reference numerals are given to the constituent members having the same functions as those in the first or fifth embodiment even if the shapes are slightly different, and the description thereof is omitted because it is duplicated.
 この実施例では、外面係合部14aが主軸C1に平行な複数の鋸歯状に形成されているため、本体11eを押圧するだけで前記実施例1~3における本体11、11bのねじ込むための回転操作を省くことができることから椎体L1、L2間に短時間で嵌入し固定することができ、操作性が向上する。 In this embodiment, since the outer surface engaging portion 14a is formed in a plurality of sawtooth shapes parallel to the main shaft C1, the rotation for screwing the main bodies 11, 11b in the first to third embodiments just by pressing the main body 11e. Since the operation can be omitted, the vertebral bodies L1 and L2 can be inserted and fixed in a short time, and the operability is improved.
 また、外面係合部14aである鋸歯はそれぞれ前後端面が後方に傾斜し、径方向外面頭頂部及び軸方向先端部は尖鋭刃状に形成されているため、本体11eを押圧することにより椎体L1、L2間に容易に嵌入させることができるとともに、本体11eの抜け止めによる固定の信頼性が確保できる。 In addition, since the front and rear end surfaces of the saw teeth that are the outer surface engaging portions 14a are inclined rearward, and the radial outer surface vertex and the axial tip are formed in a sharp blade shape, the vertebral body is pressed by pressing the main body 11e. In addition to being able to easily fit between L1 and L2, it is possible to secure the reliability of fixing by preventing the main body 11e from coming off.
 図23は、本発明のまた別の実施形態(実施例7)の椎体間固定装置10fの概念を示す縦断面図(主要部断面)である。 FIG. 23 is a longitudinal sectional view (major section) showing the concept of an interbody fusion device 10f according to another embodiment (Example 7) of the present invention.
 実施例7の椎体間固定装置10fは、実施例1の椎体間固定装置10に対して、ピン30aの形状が比較的短いストレート状に形成されている点、及び押圧ねじ40aの先端部43aの形状が異なるだけで、他は実施例1と全く同様の構成である。従ってここで、実施例1と同様の機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してあり、個々の説明は重複するので省略する。 The interbody fusion device 10f according to the seventh embodiment is different from the interbody fusion device 10 according to the first embodiment in that the pin 30a has a relatively short straight shape and the tip of the pressing screw 40a. The configuration is the same as that of the first embodiment except that the shape of 43a is different. Therefore, the same reference numerals are given to constituent members having the same functions as those in the first embodiment even if the shapes are slightly different, and the description thereof will be omitted because they are duplicated.
 実施例7の1対のピン30a、30aは、比較的短いストレート状に形成され、それぞれ1対のガイド孔17、18内に遊嵌収容される。各先端32aは、適宜尖鋭状に形成され、本体11が椎体L1、L2間に差込まれる前の初期状態においては、図23の2点差線で示すように、雄ねじ14の谷径以内にすなわち谷径から突出しないようガイド孔17、18の出口内に収容されている。 The pair of pins 30a and 30a of the seventh embodiment are formed in a relatively short straight shape, and are loosely accommodated in the pair of guide holes 17 and 18, respectively. Each tip 32a is formed in a sharp shape as appropriate, and in the initial state before the main body 11 is inserted between the vertebral bodies L1 and L2, as shown by the two-dot difference line in FIG. That is, it is accommodated in the outlets of the guide holes 17 and 18 so as not to protrude from the valley diameter.
 押圧ねじ40aは、前記実施例1の押圧ねじ40と同様な形状の雄ねじ部41及びキャップ42を有するが、雄ねじ部41の先端部43aが中空内面16aより僅かに細い丸棒状に延設され、その先端角部がピン30a、30aの後端31a、31aに当接するようにカットされた傾斜面43aが形成されている。 The pressing screw 40a has a male screw portion 41 and a cap 42 having the same shape as the pressing screw 40 of the first embodiment, but the distal end portion 43a of the male screw portion 41 extends in a round bar shape slightly thinner than the hollow inner surface 16a. An inclined surface 43a is formed that is cut so that the corners of the front end are in contact with the rear ends 31a and 31a of the pins 30a and 30a.
 図24の(a)は本発明のまた別の実施形態(実施例8)の椎体間固定装置10gの概念を示す縦断面図(主要部断面)、(b)は(a)のI-I矢視要部断面図である。 FIG. 24 (a) is a longitudinal sectional view (main section) showing the concept of an interbody fusion device 10g according to another embodiment (Example 8) of the present invention, and FIG. It is I arrow principal part sectional drawing.
 実施例8の椎体間固定装置10gは、実施例7の椎体間固定装置10eに対して、ピン30bの形状が比較的長いストレート状に形成されている点、及び1対のピン30b、30bを収容する1対のガイド孔17a、18aの配置が異なるだけで、他は実施例7と全く同様の構成である。従ってここで、実施例7と同様の機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してあり、個々の説明は重複するので省略する。 The interbody fusion device 10g according to the eighth embodiment has a relatively long straight shape with respect to the interbody fusion device 10e according to the seventh embodiment, and a pair of pins 30b. The rest of the configuration is exactly the same as that of the seventh embodiment except that the arrangement of the pair of guide holes 17a and 18a for accommodating 30b is different. Therefore, the same reference numerals are given to the structural members having the same functions as those in the seventh embodiment even though the shapes are slightly different, and the description thereof will be omitted because they are duplicated.
 実施例8の1対のピン30b、30bは、比較的長いストレート状に形成され、それぞれ後述する1対のガイド孔17a、18a内に遊嵌収容される。各先端32bは、適宜尖鋭状に形成され、本体11が椎体L1、L2間に差込まれる前の初期状態(待機位置)においては、図24(a)の2点差線で示すように、雄ねじ14の谷径以内に、すなわち谷径から突出しないようガイド孔17a、18aの出口内に収容されている。 The pair of pins 30b and 30b of the eighth embodiment are formed in a relatively long straight shape and are loosely accommodated in a pair of guide holes 17a and 18a, which will be described later. Each tip 32b is appropriately sharpened, and in the initial state (standby position) before the main body 11 is inserted between the vertebral bodies L1 and L2, as shown by the two-point difference line in FIG. It is accommodated in the outlets of the guide holes 17a and 18a within the valley diameter of the male screw 14, that is, so as not to protrude from the valley diameter.
 本体11gに設けられる一対のガイド孔17a、18a内に収容されるピン30b、30bは、図24(b)に示すように、本体11gの中心軸に対して例えば左右に偏心して配置されている。これにより、1対のピン30b、30bの前記待機位置における後端31b、31b部の相互干渉を回避することができる。 As shown in FIG. 24B, the pins 30b and 30b accommodated in the pair of guide holes 17a and 18a provided in the main body 11g are arranged eccentrically with respect to the central axis of the main body 11g, for example. . Thereby, the mutual interference of the rear ends 31b and 31b at the standby position of the pair of pins 30b and 30b can be avoided.
 なお、一対のガイド孔17a、18aの中心軸である傾斜軸C2、C3は、この実施例では中心軸に対してそれぞれ略平行面内に配置されているが、ピン30bの先端32bが押し込まれて椎体L1、L2の外面からはみ出さない限り、主軸C1に対しそれぞれ任意の方向に且つ非対称に配置されてもよく、あるいは主軸C1に対し偏心し且つ任意の方向の面内に配置されてもよい。 In this embodiment, the inclined axes C2 and C3, which are the central axes of the pair of guide holes 17a and 18a, are arranged in a plane substantially parallel to the central axis, but the tip 32b of the pin 30b is pushed in. As long as they do not protrude from the outer surfaces of the vertebral bodies L1 and L2, they may be arranged in any direction and asymmetrically with respect to the main axis C1, or they are eccentric with respect to the main axis C1 and arranged in a plane in any direction. Also good.
 図25は、本発明のまた別の実施形態(実施例9)の椎体間固定装置10hの概念を示す縦断面図(主要部断面)である。 FIG. 25 is a longitudinal sectional view (major section) showing the concept of an interbody fusion device 10h according to another embodiment (Example 9) of the present invention.
 実施例9の椎体間固定装置10hは、実施例8の椎体間固定装置10gに対して、1対のピン30c、30c及びガイド孔17c、18cの形状が先端方向に向かってそれぞれ緩やかな凹状の円弧又は曲線状に形成されている点が異なるだけで、他は実施例8と全く同様の構成である。従ってここで、実施例8と同様の機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してあり、個々の説明は重複するので省略する。 In the interbody fusion device 10h according to the ninth embodiment, the shape of the pair of pins 30c and 30c and the guide holes 17c and 18c is gentler toward the distal end than the interbody fusion device 10g according to the eighth embodiment. The rest of the configuration is exactly the same as that of the eighth embodiment except that it is formed in a concave arc or curve. Therefore, the same reference numerals are given to the structural members having the same functions as those of the eighth embodiment even if the shapes are slightly different, and the descriptions thereof are omitted because they are duplicated.
 本体11hに設けられる凹状の円弧又は曲線状の一対のガイド孔17c、18cは、1対のピン30c、30cの待機位置における後端31c、31c部の相互干渉を回避するように、本体11hの中心軸に対し例えば左右に偏心させ、ピン30cの先端32cが押し込まれて椎体L1、L2の外面からはみ出さない限り、任意の方向に沿って配置することができる。 A pair of concave arcs or curved guide holes 17c, 18c provided in the main body 11h is provided on the main body 11h so as to avoid mutual interference between the rear ends 31c, 31c at the standby position of the pair of pins 30c, 30c. For example, the pin 30c can be arranged along an arbitrary direction as long as the tip 32c of the pin 30c is pushed and does not protrude from the outer surface of the vertebral bodies L1 and L2 with respect to the central axis.
 図26は、本発明のさらに別の実施形態(実施例10)の椎体間固定装置10iの概念を示す縦断面図(主要部断面)である。 FIG. 26 is a longitudinal sectional view (major section) showing the concept of an interbody fusion device 10i of still another embodiment (Example 10) of the present invention.
 実施例10の椎体間固定装置10iは、実施例9の椎体間固定装置10hに対して、1対のピン30d、30d及びガイド孔17d、18dの形状が先端方向に向かってそれぞれ緩やかな凸状の円弧又は曲線状に形成されている点が異なるだけで、他は実施例9と全く同様の構成である。従ってここで、実施例9と同様の機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してあり、個々の説明は重複するので省略する。 In the interbody fusion device 10i of the tenth embodiment, the shape of the pair of pins 30d and 30d and the guide holes 17d and 18d is gentler toward the distal end than the interbody fusion device 10h of the ninth embodiment. The rest of the configuration is exactly the same as that of the ninth embodiment except that it is formed in a convex arc or curve. Therefore, the same reference numerals are given to the structural members having the same functions as those in the ninth embodiment even if the shapes are slightly different.
 実施例10においても、本体11iに設けられる凸状の円弧又は曲線状の一対のガイド孔17d、18dは、1対のピン30d、30dの待機位置における後端31d、31d部の相互干渉を回避するように、本体11iの中心軸に対し例えば左右に偏心させ、ピン30dの先端32dが押し込まれて椎体L1、L2の外面からはみ出さない限り、任意の方向に沿って配置することができる。 Also in the tenth embodiment, the pair of convex arcs or curved guide holes 17d and 18d provided in the main body 11i avoids mutual interference between the rear ends 31d and 31d at the standby position of the pair of pins 30d and 30d. Thus, it can be arranged along any direction as long as it is decentered, for example, left and right with respect to the central axis of the main body 11i and the tip 32d of the pin 30d is pushed and does not protrude from the outer surface of the vertebral bodies L1 and L2. .
 図44は本発明のまた別の実施形態(実施例11)による椎体間固定装置10jの概念を示す縦断面図(主要部断面)、図45は図44の押圧ねじ40jを取外した状態のX-X矢視図である。 44 is a longitudinal sectional view (main section) showing the concept of an interbody fusion device 10j according to still another embodiment (Example 11) of the present invention, and FIG. 45 is a state in which the pressing screw 40j of FIG. 44 is removed. FIG.
 実施例11の椎体間固定装置10jは、実施例1の椎体間固定装置10に対して、一対のピン30j、30jが後端に雌ねじ穴34が設けられた基端部33が一体的に形成され連設されている点、押圧ねじ40jに基端部33の雌ねじ穴34と同軸の挿通孔44が開設されている点が異なるだけで、他は実施例1と全く同様の構成である。従ってここで、実施例1と同様な機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してある。 The interbody fusion device 10j according to the eleventh embodiment is integrated with the base end portion 33 in which a pair of pins 30j and 30j are provided with a female screw hole 34 at the rear end of the interbody fusion device 10 according to the first embodiment. The only difference is that the press screw 40j is provided with an insertion hole 44 that is coaxial with the female screw hole 34 of the base end 33, and the other configuration is exactly the same as in the first embodiment. is there. Accordingly, here, the same reference numerals are given to the constituent members having the same functions as those in the first embodiment even if the shapes are slightly different.
 なお、この実施例を含む上記実施例の押圧ねじ40、40jは本体11~11i内への螺合方向とは逆方向の回転操作により本体11~11i内から、本体11~11iは椎体間への嵌入方向とは逆方向への回転及び/又は引抜き操作により椎体間からそれぞれ取外され体外に取出し可能である。 It should be noted that the pressing screws 40 and 40j of the above embodiments including this embodiment are moved from the main body 11 to 11i by the rotation operation in the direction opposite to the screwing direction into the main bodies 11 to 11i, and the main bodies 11 to 11i are intervertebral bodies. It can be removed from between the vertebral bodies by rotation and / or extraction operation in the direction opposite to the direction of insertion into the body, and can be taken out of the body.
 この実施例の椎体間固定装置10jは、ピン30j、30jを介して椎体間に固定された後で万一感染症などによる不慮の化膿障害が発生した場合に、押圧ねじ40jを本体11から引抜くとともに、ピン30j、30jを基端部33の雌ねじ穴34に螺合する雄ねじ部95aを備えた引抜きドライバー95により椎体内から引抜いて本体11と共に体外に取出すことができる。その後、椎体間に抗生剤や必要に応じて骨材等を詰める等の処置を施してから再度椎体間固定装置10jを椎体間に固定し直すことができる。 The interbody fusion device 10j according to this embodiment is configured so that the pressing screw 40j is attached to the main body 11 when an unexpected suppuration disorder due to infection or the like occurs after being fixed between the vertebral bodies via the pins 30j and 30j. Can be pulled out from the vertebral body by a pulling driver 95 having a male screw portion 95a for screwing the pins 30j and 30j into the female screw hole 34 of the base end portion 33 and taken out of the body together with the main body 11. Thereafter, the intervertebral body fixing device 10j can be re-fixed between the vertebral bodies after a treatment such as filling the vertebral bodies with antibiotics or aggregates if necessary.
 ここで、ピン30j、30jを椎体内から引抜き先端部32jが本体11のガイド穴17内に隠れるまで引抜く空間が雌ねじ16内に確保できれば押圧ねじ40jを本体11から完全に取外さなくともよく、押圧ねじ40jに開設された挿通孔4内に引抜きドライバー95を挿通させてピン30jの基端部33の雌ねじ穴34内に先端部の雄ねじ部95aを螺合させることができるので、以降ピン30j、30jを前記引抜き操作により椎体内から引抜いて本体11と共に体外に取出すことができる。 Here, if the space for extracting the pins 30j and 30j from the vertebral body until the distal end portion 32j is hidden in the guide hole 17 of the main body 11 can be secured in the female screw 16, the pressing screw 40j does not have to be completely removed from the main body 11. Well, since the extraction screwdriver 95 can be inserted into the insertion hole 4 provided in the pressing screw 40j and the male screw portion 95a at the distal end portion can be screwed into the female screw hole 34 of the base end portion 33 of the pin 30j. The pins 30j and 30j can be extracted from the vertebral body by the above-described extraction operation and taken out of the body together with the main body 11.
 また、ピン30j基端部33の雌ねじ穴34内には、通常、後端部に例えばプラスドライバ溝や六角穴などの被係合部を有する盲プラグ(図示しないが、図44の雄ねじ部95aに相当する)が挿嵌されており、ピン30j、30jの前記引抜き操作に先立ち、前記被係合部に係合する係合部を先端部に備えたドライバー(図示しない)により前記盲プラグを雌ねじ穴34内から取外し体外に取出すことができる。 Further, in the female screw hole 34 of the base end portion 33 of the pin 30j, normally, a blind plug (not shown, male screw portion 95a in FIG. 44) having an engaged portion such as a plus driver groove or a hexagonal hole at the rear end portion is usually provided. Is inserted and the blind plug is inserted by a screwdriver (not shown) having an engaging portion at the tip thereof that engages with the engaged portion prior to the pulling operation of the pins 30j and 30j. It can be removed from the female screw hole 34 and taken out of the body.
 このピン30j基端部33の雌ねじ穴34内に取出し可能に挿嵌された盲プラグにより雌ねじ穴34内に椎体間内髄液や骨形成材料等の異物の侵入を防止することから、ピンの引抜き操作に先立ち盲プラグを取外すことによりピン基端部の雌ねじ穴に引抜きドライバーを容易に素早くねじ込み易くすることができ、椎体間固定装置10j取外しの操作性が向上する。 The blind plug inserted in the female screw hole 34 of the base end portion 33 of the pin 30j so as to be able to be taken out prevents foreign matter such as intervertebral spinal fluid or bone forming material from entering the female screw hole 34. By removing the blind plug prior to the extraction operation, the extraction driver can be easily and quickly screwed into the female screw hole at the base end portion of the pin, and the operability of removing the interbody fusion device 10j is improved.
 なお、雌ねじ穴34内に挿嵌された盲プラグは、本体11の雌ねじ16内に螺合された状態の押圧ねじ40jの挿通孔44内にいずれも図示しない前記ドライバーを挿通させて盲プラグ後端部の被係合部に係合させて雌ねじ穴34内から取外すことができる。 The blind plug inserted in the female screw hole 34 is inserted into the insertion hole 44 of the pressing screw 40j in a state of being screwed into the female screw 16 of the main body 11, and the driver (not shown) is inserted through the blind plug. It can be detached from the female screw hole 34 by engaging with the engaged portion at the end.
 また、押圧ねじに挿通孔44を設けない場合は、先に雌ねじ穴34内に前記盲プラグを挿嵌した状態でピン30j、30jを本体11の雌ねじ16内に装着し、椎体間固定装置取外しの際には押圧ねじを対外に取出してから順次盲プラグ、ピン30j、30jの取出し操作を行うことができる。 Further, when the insertion hole 44 is not provided in the pressing screw, the pins 30j and 30j are mounted in the female screw 16 of the main body 11 with the blind plug inserted in the female screw hole 34 first, and the interbody fusion device At the time of removal, it is possible to sequentially take out the blind plug and the pins 30j and 30j after taking out the pressing screw to the outside.
 図46は本発明のさらに別の実施形態(実施例12)による椎体間固定装置10kの概念を示す縦断面図(主要部断面)、図47は図46の押圧ねじ40kを取外した状態のX-X矢視図である。 46 is a longitudinal cross-sectional view (main cross-sectional view) showing a concept of an interbody fusion device 10k according to still another embodiment (Example 12) of the present invention, and FIG. 47 is a state in which the pressing screw 40k of FIG. 46 is removed. FIG.
 実施例12の椎体間固定装置10kは、実施例11の椎体間固定装置10jに対して、一対のピン30k、30kがそれぞれ後端に雌ねじ穴34kが設けられた基端部33kが個別に形成され連設されている点、押圧ねじ40kに基端部33kの雌ねじ穴34kとそれぞれ同軸の一対の挿通孔45、45が開設されている点が異なるだけで、他は実施例11と全く同様の構成である。従ってここで、実施例11と同様な機能を有する構成部材には一部形状が若干異なっていても同一の符号を付してある。 The interbody fusion device 10k according to the twelfth embodiment is different from the interbody fusion device 10j according to the eleventh embodiment in that the pair of pins 30k and 30k each have a base end portion 33k provided with a female screw hole 34k at the rear end. The only difference is that the press screw 40k is provided with a pair of insertion holes 45, 45 coaxial with the female screw hole 34k of the base end portion 33k, respectively, except that the pressing screw 40k is provided in a continuous manner. The configuration is exactly the same. Therefore, here, the same reference numerals are given to the structural members having the same functions as those of the eleventh embodiment even if the shapes are slightly different.
 なお、この実施例の押圧ねじ40kも本体11内への螺合方向とは逆方向の回転操作により本体11内から、本体11も椎体間への嵌入方向とは逆方向への回転及び引抜き操作により椎体間からそれぞれ取外され体外に取出し可能となっている。 Note that the pressing screw 40k of this embodiment is also rotated and pulled out from the inside of the main body 11 in the direction opposite to the screwing direction into the main body 11, and the main body 11 is also rotated in the direction opposite to the fitting direction between the vertebral bodies. It can be removed from between the vertebral bodies by the operation and can be taken out of the body.
 この実施例の椎体間固定装置10kも、ピン30k、30kを介して椎体間に固定された後で万一感染症などによる不慮の化膿障害が発生した場合に、押圧ねじ40kを本体11から引抜くとともに、ピン30k、30kを基端部33k、33kの雌ねじ穴34k、34kにそれぞれ螺合する雄ねじ部96aを備えた引抜きドライバー96により椎体内から引抜いて本体11と共に体外に取出すことができる。その後、椎体間に抗生剤や必要に応じて骨材等を詰める等の処置を施してから再度椎体間固定装置10kを椎体間に固定し直すことができる。 In the interbody fixing device 10k of this embodiment, the pressing screw 40k is attached to the main body 11 in the event that an unexpected suppuration disorder due to infection or the like occurs after being fixed between the vertebral bodies via the pins 30k, 30k. And the pins 30k and 30k are pulled out from the vertebral body by a pull-out driver 96 having male screw portions 96a screwed into the female screw holes 34k and 34k of the base end portions 33k and 33k, respectively, and taken out from the body together with the main body 11. Can do. Thereafter, the intervertebral body fixing device 10k can be re-fixed between the vertebral bodies after a treatment such as packing between the vertebral bodies with antibiotics or aggregates as necessary.
 また、ピン30k基端部33kの雌ねじ穴34k内にも、通常、後端部に例えばプラスドライバ溝や六角穴などの被係合部を有する盲プラグ(図示しないが、図46の雄ねじ部96aに相当する)が挿嵌されており、ピン30k、30kの前記引抜き操作に先立ち、前記盲プラグがそれぞれ前記被係合部に係合する係合部を先端部に備えたドライバー(図示しない)により雌ねじ穴34k内から取外され体外に取出すことができる。 Also, a blind plug (not shown, but not shown, male threaded portion 96a in FIG. 46) having a engaged portion such as a Phillips screwdriver groove or a hexagonal hole in the rear end portion is also usually provided in the female threaded hole 34k of the base end portion 33k of the pin 30k. And a screwdriver (not shown) provided with engaging portions at the distal end portions of the blind plugs to engage with the engaged portions prior to the pulling-out operation of the pins 30k and 30k. Can be removed from the female screw hole 34k and taken out of the body.
 以下、前記盲プラグ及びピン30k、30kの引抜き操作は、前記実施例11と同様に行うことができるので、詳細な説明は省略する。 Hereinafter, since the operation of pulling out the blind plug and the pins 30k and 30k can be performed in the same manner as in Example 11, detailed description thereof will be omitted.
 以上に記した種々の実施形態の他に、各部材の形状、寸法及び材質は任意に変更することができる。例えば、図示しないが、ピン30、30A~30F、30a~30d、30j、30kは、極端な場合椎体L1、L2のいずれか側に1本、あるいは略軸対称又は非対称に2対など複数配置することもできる。ただし、ピン30、30A~30F、30a~30d、30j、30kは、数量を増やすに従って外径が本体11、11b~11iの雌ねじ16内に収容されるスペース内に相応して細くなる。 In addition to the various embodiments described above, the shape, size and material of each member can be arbitrarily changed. For example, although not shown, a plurality of pins 30, 30A to 30F, 30a to 30d, 30j, and 30k are arranged on one side of the vertebral bodies L1 and L2 in the extreme case, or two pairs such as substantially axisymmetric or asymmetrical. You can also However, the pins 30, 30A to 30F, 30a to 30d, 30j, and 30k are correspondingly thinner in the space accommodated in the female screw 16 of the main body 11, 11b to 11i as the quantity increases.
 また、例えば実施例5における本体11の外面係合部14bがスプライン歯の径方向外面頭頂部を複数の連続的な鋸歯状に形成することもできる。 Further, for example, the outer surface engaging portion 14b of the main body 11 in the fifth embodiment can form the radial outer surface top portion of the spline teeth in a plurality of continuous sawtooth shapes.
 また、固定補強具60の1対のアーム62を横断面T字形ではなく、少なくとも先端部側を一枚板状にして、さらにその板の前面上に先鋭なピン状突起を1個又は複数形成することも可能である。アーム62先端部にこのような先鋭なピン状突起又は尖鋭刃などを設けることにより、椎体L1、L2の前面部に係合溝L1b、L2bを設けることなく(固定補強具係合溝穿設工程を省略)、アーム62先端部を椎体L1、L2の前面部に押圧して前記ピン状突起又は尖鋭刃を直接差込み固定することも可能である。 In addition, the pair of arms 62 of the fixed reinforcing member 60 is not T-shaped in cross section, but at least the tip side is formed as a single plate, and one or more sharp pin-like protrusions are formed on the front surface of the plate. It is also possible to do. By providing such a sharp pin-like protrusion or sharp blade at the tip of the arm 62, the engaging grooves L1b and L2b are not provided in the front surface of the vertebral bodies L1 and L2 (fixed reinforcing tool engaging groove drilling It is also possible to press the tip of the arm 62 against the front surface of the vertebral bodies L1 and L2 and directly insert and fix the pin-like protrusions or sharp blades.
 さらに、例えば本体嵌入ドライバー80は、図示しないが、シャフト部81を長手方向2分割で着脱可能な連結型とすることもできる。これにより、押圧ねじドライバー90の先端係合部93に押圧ねじ40、50、40aの後端係合部44を係合した状態で、把持部82側シャフト部81を分離して短くなった先端係合部83側シャフト部81内に挿入し易くなり、その後把持部82側シャフト部81を再連結することができ、操作性が向上する。 Further, for example, although the main body insertion driver 80 is not illustrated, the shaft portion 81 can be a connection type that can be attached and detached in two in the longitudinal direction. As a result, the front end engaging portion 93 of the pressing screw driver 90 is engaged with the rear end engaging portion 44 of the pressing screw 40, 50, 40 a, and the gripping portion 82 side shaft portion 81 is separated and shortened. It becomes easy to insert into the engaging portion 83 side shaft portion 81, and then the gripping portion 82 side shaft portion 81 can be reconnected, thereby improving operability.
 なお、以上述べた実施例の椎体間固定装置10、10a~10i、10j、10kは、2つの隣接する椎体L1、L2の間の椎間板スペースM部に嵌入して椎体L1、L2間を固定する椎体間固定装置であって、椎間板Mに直接嵌入できるが、ヘルニヤその他の欠陥あるいは老化などにより押し潰され損傷した椎間板Mを必要に応じ取り除いてから椎体L1、L2間に嵌入してもよい。 Note that the interbody fusion devices 10, 10a to 10i, 10j, and 10k of the embodiments described above are inserted into the intervertebral disc space M between two adjacent vertebral bodies L1 and L2, and between the vertebral bodies L1 and L2. The intervertebral body fixing device can be directly inserted into the intervertebral disc M, but is inserted between the vertebral bodies L1 and L2 after removing the intervertebral disc M that has been crushed and damaged by hernia or other defects or aging as necessary. May be.
 10、10a、10b、10c、10d、10e、10f、10g、10h、10i、10j、10k 椎体間固定装置
 11、11b、11c、11d、11e、11g、11h、11i 本体
 12   前端面
 13   後端面
 14   外面係合部((部分)雄ねじ)
 14a  外面係合部(スプライン歯)
 14b  先端部(尖鋭刃)
 14c  外面係合部(鋸歯)
 15   外面係合部((完全)雄ねじ)
 16   雌ねじ
 16a  中空内面
 17、17a、17c、17d、18、18a、18c、18d ガイド孔
 19   カット側面
 21、22、23 側面開口
 24、25、26 上下面開口
 27   後端開口
 28   小穴
 29、44、54 後端係合部
 30、30A、30B、30C、30D、30E、30F、30a、30b、30c、30d、30j、30k ピン
 30An、30Dn 薄板材
 30Bn、30En、30Cn、30Fn 線材
 31、31a、31b、31c、31d、31j、31k (ピンの)後端
 32、32a、32b、32c、32d、32j、32k (ピンの)先端
 33、33k 基端部
 34、34k 雌ねじ穴
 40、40a、40j、40k、50 押圧ねじ
 41、41j、41k、51、95a、96a 雄ねじ部
 42、42j、42k、52 キャップ
 43、53 先端面
 43a  先端部
 43b  傾斜面
 44、45 挿通孔
 55   摩擦板
 55a  ピン固定溝
 60   固定補強具
 61   ボス
 62   アーム
 62a  フランジ
 62b  ウエブ
 70、70´、70´´ (椎体間固定外科手術用)椎体間スペース保持装置
 70a、70´a 保持装置本体
 70b、70´b クランプアーム開閉管
 71、71´ 第1のシャフト部
 71a、71´a、76a 先端部
 71b  ガイド筒
 71c  針状突起
 72、77、82、92 把持部
 72a、77a、82a、92a ボス部
 73、73´ スペーサー
 74、74´ クランプアーム
 74a  弾性支持部
 74´a 支持部
 74b  固定爪
 74c  尖鋭突起
 75   補強板
 75a  後部支持部材
 75b  前部支持部材
 75c  挿通孔
 76   第2のシャフト部
 76´  椎体固定機構
 76´a ねじ部
 76´b 長尺固定ねじ部材
 76´c 頭部
 78   ブラケット
 79   リンク部材
 80   本体嵌入ドライバー
 81、91 シャフト部
 83、93 先端係合部
 90   押圧ねじドライバー
 95、96 引抜きドライバー
 Bd   脊柱手術台
 C1   (本体の)主軸
 C2、C3 (ガイド孔の)傾斜軸(中心軸)
 K    カニューレ
 L    脊柱(脊椎)
 L1、L2 椎体(椎骨)
 L1a、L2a 対向面
 L1b、L2b 係合溝
 M    椎間板(椎間板スペース)
 Ma、Mb、Mc、Md、Me (内視鏡用)ポート
 Mf   切開創
 MN   生体(人体)
 MN1  腹(部)
 MN2  背(部)
 P1   第1の支持軸
 P2   第2の支持軸
 P3   第3の支持軸
 X1、X1´ 全閉位置
 X2   椎体把持/固定位置
 X3、X3´ 全開位置
 Θ1、Θ2 傾斜角
10, 10a, 10b, 10c, 10d, 10e, 10f, 10g, 10h, 10i, 10j, 10k Interbody fusion device 11, 11b, 11c, 11d, 11e, 11g, 11h, 11i Main body 12 Front end surface 13 Rear end surface 14 Outer surface engaging part ((part) male thread)
14a Outer surface engaging part (spline teeth)
14b Tip (sharp blade)
14c Outer surface engaging part (saw tooth)
15 Outer surface engaging part ((complete) male thread)
16 Female thread 16a Hollow inner surface 17, 17a, 17c, 17d, 18, 18a, 18c, 18d Guide hole 19 Cut side surface 21, 22, 23 Side opening 24, 25, 26 Upper lower surface opening 27 Rear end opening 28 Small hole 29, 44, 54 Rear end engaging portion 30, 30A, 30B, 30C, 30D, 30E, 30F, 30a, 30b, 30c, 30d, 30j, 30k Pin 30An, 30Dn Thin plate material 30Bn, 30En, 30Cn, 30Fn Wire rod 31, 31a, 31b 31c, 31d, 31j, 31k (Pin) rear end 32, 32a, 32b, 32c, 32d, 32j, 32k (Pin) front end 33, 33k Base end 34, 34k Female screw hole 40, 40a, 40j, 40k , 50 Press screw 41, 41j, 41k, 51, 95a, 96a Male thread part 42 42j, 42k, 52 Cap 43, 53 Tip surface 43a Tip portion 43b Inclined surface 44, 45 Insertion hole 55 Friction plate 55a Pin fixing groove 60 Fixing reinforcement 61 Boss 62 Arm 62a Flange 62b Web 70, 70 ′, 70 ″ ( Interbody space holding device 70a, 70'a Holding device body 70b, 70'b Clamp arm open / close tube 71, 71 'First shaft portion 71a, 71'a, 76a Tip portion 71b Guide cylinder 71c Needle-like protrusions 72, 77, 82, 92 Grip part 72a, 77a, 82a, 92a Boss part 73, 73 'Spacer 74, 74' Clamp arm 74a Elastic support part 74'a Support part 74b Fixing claw 74c Sharp protrusion 75 Reinforcing plate 75a Rear support member 75b Front support member 75c Insertion hole 7 Second shaft portion 76 'Vertebral body fixing mechanism 76'a Screw portion 76'b Long fixing screw member 76'c Head 78 Bracket 79 Link member 80 Body insertion driver 81, 91 Shaft portion 83, 93 Tip engagement portion 90 Press screw driver 95, 96 Pull-out driver Bd Spine operating table C1 (main body) main axis C2, C3 (guide hole) inclined axis (central axis)
K cannula L spine (spine)
L1, L2 Vertebral bodies (vertebrae)
L1a, L2a Opposing surfaces L1b, L2b Engagement groove M Intervertebral disc (disc space)
Ma, Mb, Mc, Md, Me (for endoscope) port Mf Incision wound MN Living body (human body)
MN1 belly (part)
MN2 back (part)
P1 First support shaft P2 Second support shaft P3 Third support shaft X1, X1 ′ Fully closed position X2 Vertebral body grasping / fixing position X3, X3 ′ Fully open position Θ1, Θ2 Inclination angle

Claims (25)

  1.  2つの隣接する椎体(椎骨)間の適正な間隔を保持するように形成された前端有底の略中空円筒又は先細り中空円錐台の外面に前記2つの椎体の対向面部に係合する外面係合部が形成されるとともに、後端側の中空内面に適宜深さの雌ねじが形成され、さらに該雌ねじの先端中空内面から前記椎体の対向面に向かって径方向に末広がりに傾斜し外面まで貫通する1つ又は複数の屈曲状又はストレート状のガイド孔が穿設された本体と、
     前記ガイド孔内に遊嵌収容された屈曲状又はストレート状の1本又は複数のピンと、
     前記本体の雌ねじに螺合しその軸方向推進力により、前記ピンの後端を押圧する押圧ねじと、
    を備え、
     前記本体が前記椎体間の椎間板スペースに外面係合部を介して嵌入され固定された後に、前記ピンが前記本体の雌ねじに螺合された押圧ねじの軸方向推進力により後端を押圧されて先端側がガイド孔に沿って順次案内され前記椎体内に差込まれる椎体間固定装置を具備することを特徴とする椎体間固定外科手術システム。
    An outer surface that engages the opposing surface portions of the two vertebral bodies on the outer surface of a generally hollow cylinder or tapered hollow truncated cone with a front end formed so as to maintain an appropriate distance between two adjacent vertebral bodies (vertebrae) An engaging portion is formed, and a female screw of an appropriate depth is formed on the hollow inner surface on the rear end side. Further, the outer surface is inclined outwardly from the hollow inner surface of the distal end of the female screw toward the opposite surface of the vertebral body in the radial direction. A main body with one or more bent or straight guide holes penetrating to
    One or a plurality of bent or straight pins loosely accommodated in the guide holes;
    A pressing screw that is screwed into the female screw of the main body and presses the rear end of the pin by its axial propulsive force;
    With
    After the main body is inserted and fixed in the intervertebral disc space via the outer surface engaging portion, the rear end is pressed by the axial thrust of the pressing screw screwed into the female screw of the main body. An interbody fusion surgery system comprising an interbody fusion device in which a distal end side is sequentially guided along a guide hole and inserted into the vertebral body.
  2.  前記略中空円筒形本体の中央部外径が僅かに太めの太鼓状に形成されていることを特徴とする請求項1記載の椎体間固定外科手術システム。 The interbody fusion surgical system according to claim 1, wherein the outer diameter of the central portion of the substantially hollow cylindrical main body is formed in a slightly thick drum shape.
  3.  前記ピンは、丸や多角形を含む任意断面形状の中実又は中空の棒状体もしくは少なくとも先端側又は全長に亘り複数の薄板材又は丸や各種扁平型を含む任意断面形を有する線材が積層されて一体的な丸や多角形を含む任意断面形状の棒状積層体からなり、その先端部が尖鋭状に形成されていることを特徴とする請求項1記載の椎体間固定外科手術システム。 The pin is a solid or hollow rod-shaped body having an arbitrary cross-sectional shape including a circle and a polygon, or a plurality of thin plate materials or a wire having an arbitrary cross-section including a circle and various flat shapes over the entire length. 2. The interbody fusion surgery system according to claim 1, wherein the system comprises a bar-shaped laminate having an arbitrary cross-sectional shape including an integral circle and polygon, and the tip portion thereof is formed in a sharp shape.
  4.  前記1本又は複数のピンは、後端に雌ねじ穴が設けられた基端部が個別又は一体的に形成され連設されており、
     前記押圧ねじは前記本体内への螺合方向とは逆方向の回転操作により前記本体内から、前記本体は前記椎体間への嵌入方向とは逆方向への回転及び/又は引抜き操作により椎体間からそれぞれ取外され体外に取出し可能であって、
     前記ピンが椎体内に差込まれた後で、前記押圧ねじが前記本体から引抜かれるとともに、前記ピンが基端部の雌ねじ穴に螺合する雄ねじ部を先端部に備えた引抜きドライバーにより前記椎体間から引抜かれ、前記本体と共に体外に取出されるように構成されていることを特徴とする請求項1乃至請求項3のいずれか1項記載の椎体間固定外科手術システム。
    The one or more pins have a base end portion provided with a female screw hole at the rear end, and are individually or integrally formed and connected.
    The pressing screw is rotated from the inside of the main body by a rotation operation in a direction opposite to the screwing direction into the main body, and the main body is rotated by a rotation and / or extraction operation in a direction opposite to the insertion direction between the vertebral bodies. It can be removed from between the body and taken out of the body,
    After the pin is inserted into the vertebral body, the pressing screw is withdrawn from the main body, and the pin is screwed into the female screw hole of the base end portion by a pulling screwdriver having a male screw portion at the distal end portion. The interbody fusion surgical system according to any one of claims 1 to 3, wherein the interbody fusion surgery system is configured to be extracted from between vertebral bodies and taken out of the body together with the main body.
  5.  前記ピン基端部の雌ねじ穴内には、通常、後端部に被係合部を有する盲プラグが挿嵌されており、
     前記ピンの引抜き操作に先立ち、前記盲プラグが前記被係合部に係合する係合部を先端部に備えたドライバーにより前記雌ねじ穴内から取外され体外に取出し可能であることを特徴とする請求項4記載の椎体間固定外科手術システム。
    A blind plug having an engaged portion at the rear end is usually inserted into the female screw hole of the pin base end,
    Prior to the pulling-out operation of the pin, the blind plug can be removed from the female screw hole and taken out of the body by a screwdriver having an engaging portion that engages with the engaged portion at the tip. The interbody fusion surgical system according to claim 4.
  6.  前記外面係合部は、雄ねじ状に形成されていることを特徴とする請求項1記載の椎体間固定外科手術システム。 The interbody fusion surgical system according to claim 1, wherein the outer surface engaging portion is formed in a male screw shape.
  7.  前記外面係合部は、前記主軸に平行な複数のスプライン歯状に形成されていることを特徴とする請求項1記載の椎体間固定外科手術システム。 2. The interbody fusion surgical system according to claim 1, wherein the outer surface engaging portion is formed in a plurality of spline teeth parallel to the main axis.
  8.  前記外面係合部は、前記主軸に平行な複数の鋸歯状に形成されていることを特徴とする請求項1記載の椎体間固定外科手術システム。 The interbody fusion surgical system according to claim 1, wherein the outer surface engaging portion is formed in a plurality of sawtooth shapes parallel to the main axis.
  9.  前記外面係合部の軸方向先端及び径方向外面頭頂部が尖鋭刃状に形成されていることを特徴とする請求項1、請求項6乃至請求項8のいずれか1項記載の椎体間固定外科手術システム。 The intervertebral body according to any one of claims 1 and 6, wherein an axial tip and a radial outer surface vertex of the outer surface engaging portion are formed in a sharp edge shape. Fixed surgical system.
  10.  前記本体には、外面の上下・左右にそれぞれ連通する血管新生用開口部及び骨内部成長用開口部が複数設けられていることを特徴とする請求項1乃至請求項9のいずれか1項記載の椎体間固定外科手術システム。 10. The body according to any one of claims 1 to 9, wherein the main body is provided with a plurality of openings for angiogenesis and openings for bone ingrowth that respectively communicate with the top, bottom, left and right of the outer surface. Interbody fusion surgery system.
  11.  前記押圧ねじの後端に前記本体の後端面の全面又は一部を覆うキャップが形成されていることを特徴とする請求項1乃至請求項10のいずれか1項記載の椎体間固定外科手術システム。 The interbody fusion surgery according to any one of claims 1 to 10, wherein a cap that covers the whole or part of the rear end surface of the main body is formed at the rear end of the pressing screw. system.
  12.  前記押圧ねじに遊嵌されるボスと、
     該ボスの外面に軸対称に立設され、前記押圧ねじのキャップ部にボス部後端面が押圧されて先端部が前記隣接する椎体の腹部側前面にそれぞれ係合固定される1対のアームと、からなる固定補強具をさらに備えることを特徴とする請求項11記載の椎体間固定外科手術システム。
    A boss loosely fitted to the pressing screw;
    A pair of arms which are erected on the outer surface of the boss in an axially symmetrical manner, and the rear end surface of the boss portion is pressed against the cap portion of the pressing screw, and the front end portion is engaged and fixed to the front side of the abdomen of the adjacent vertebra The interbody fusion surgical system according to claim 11, further comprising a fixation reinforcing tool comprising:
  13.  前記本体の雌ねじ内に遊嵌収容され、前記ピンの後端部に当接配置される摩擦板をさらに備えることを特徴とする請求項1乃至請求項12のいずれか1項記載の椎体間固定外科手術システム。 The intervertebral body according to any one of claims 1 to 12, further comprising a friction plate that is loosely received in the female screw of the main body and is disposed in contact with a rear end portion of the pin. Fixed surgical system.
  14.  前記ピンの後端部が、少なくとも左右方向への移動が拘束されるように前記摩擦板に係合又は固定されていることを特徴とする請求項13記載の椎体間固定外科システム。 14. The interbody fusion surgical system according to claim 13, wherein a rear end portion of the pin is engaged with or fixed to the friction plate so that movement in at least the left-right direction is restricted.
  15.  前記椎体間固定装置は、患者の腹部側から腹腔鏡を併用した椎体間固定外科手術により前記椎体間に固定されることを特徴とする請求項1乃至請求項14のいずれか1項記載の椎体間固定外科手術システム。 The intervertebral body fixing device is fixed between the vertebral bodies by interbody fusion surgery using a laparoscope in combination from the abdominal side of the patient. The interbody fusion surgical system as described.
  16.  後端に把持部が設けられた中空長尺のシャフト部の先端に前記椎体間固定装置の本体の後端部に形成された後端係合部に係合する先端係合部を有し、
     該先端係合部を前記本体の後端係合部に係合した状態で、生体腹部から前記椎体の前面まで形成された内視鏡用腹腔部内のカニューレ内に挿入されて前記2つの隣接する椎体間の適正な間隔を保持する椎体間スペース保持装置の中空部内に挿入され、前記本体を押圧又は/及び回転することにより前記椎体間に嵌入させる本体嵌入ドライバーを備えることを特徴とする請求項1乃至請求項15のいずれか1項記載の椎体間固定外科手術システム。
    A distal end engaging portion that engages with a rear end engaging portion formed at the rear end portion of the body of the interbody fusion device at the distal end of a hollow long shaft portion provided with a grip portion at the rear end. ,
    With the distal end engaging part engaged with the rear end engaging part of the main body, the two adjacent parts are inserted into a cannula in an abdominal part for endoscope formed from a living body abdominal part to the front surface of the vertebral body. A body insertion driver that is inserted into the hollow portion of the interbody space holding device for maintaining an appropriate distance between the vertebral bodies to be inserted between the vertebral bodies by pressing or / and rotating the body. The interbody fusion surgery system according to any one of claims 1 to 15.
  17.  前記本体嵌入ドライバーは、先端係合部が金属製で、シャフト部は高分子材料からなることを特徴とする請求項16記載の椎体間固定外科手術システム。 The interbody fusion surgery system according to claim 16, wherein the main body insertion driver has a tip engaging portion made of metal and a shaft portion made of a polymer material.
  18.  後端に把持部が設けられた長尺のシャフト部の先端に前記椎体間固定装置の押圧ねじの後端部に形成された後端係合部に係合する先端係合部を有し、
     該先端係合部を前記押圧ねじの後端係合部に係合した状態で前記本体嵌入ドライバーの中空部内に挿入し、前記押圧ねじを前記椎間板スペースに固定された前記椎体間固定装置の本体の雌ねじ部に挿入して押圧しながら回転することにより前記雌ねじに螺合させその軸方向推進力により前記ピンの先端側をガイド孔に沿って順次案内させて前記椎体内に差込む押圧ねじドライバーをさらに備えることを特徴とする請求項16又は請求項17記載の椎体間固定外科手術システム。
    A distal end engaging portion that engages with a rear end engaging portion formed at the rear end portion of the pressing screw of the interbody fusion device at the distal end of a long shaft portion provided with a grip portion at the rear end. ,
    In the interbody fusion device, the distal end engaging portion is inserted into the hollow portion of the main body insertion driver in a state where the distal end engaging portion is engaged with the rear end engaging portion of the pressing screw, and the pressing screw is fixed to the intervertebral disc space. Inserted into the female threaded portion of the main body and rotated while being pressed, screwed into the female thread, and the axial propulsive force is used to sequentially guide the distal end side of the pin along the guide hole to be inserted into the vertebral body The interbody fusion surgical system according to claim 16 or 17, further comprising a screw driver.
  19.  前記押圧ねじドライバーは、先端係合部が金属製で、シャフト部は高分子材料からなることを特徴とする請求項18記載の椎体間固定外科手術システム。 19. The interbody fusion surgical system according to claim 18, wherein the pressing screw driver has a tip engaging portion made of metal and a shaft portion made of a polymer material.
  20.  生体の椎体間固定外科手術の際に、2つの隣接する椎体(椎骨)間の適正な間隔を修正して椎間板スペースを保持するための装置であって、
     後端に把持部が設けられ、生体腹部側に設けられた内視鏡用腹腔部内のカニューレを介して前記椎体の前面近傍まで挿入される中空長尺の第1のシャフト部と、
     該第1のシャフト部の先端部に軸方向に沿って延設され、前記隣接する椎体の左右両側面をそれぞれ挟持し固定する固定爪が先端に連接されて前記椎体の直交面内で開閉可能な少なくとも各1対のクランプアームと、を有する椎体クランプ機構を備えることを特徴とする椎体間固定外科手術用椎体間スペース保持装置。
    A device for correcting the proper spacing between two adjacent vertebral bodies (vertebrae) to preserve disc space during living interbody fusion surgery,
    A hollow long first shaft portion that is provided to the vicinity of the front surface of the vertebral body through a cannula in the abdominal portion for endoscope provided on the living body abdominal portion side with a gripping portion at the rear end;
    A fixing claw that extends in the axial direction at the distal end portion of the first shaft portion and clamps and fixes both the left and right side surfaces of the adjacent vertebral bodies is connected to the distal end so as to be within the orthogonal plane of the vertebral body. An intervertebral body space holding device for interbody fusion surgery, comprising a vertebral body clamp mechanism having at least one pair of clamp arms that can be opened and closed.
  21.  前記椎体クランプ機構は、
     先端に前記各固定爪が連設され、後端部が前記第1のシャフト部の先端部に連設され、フリー状態では前記固定爪をそれぞれ前記椎体の直交面内で拡径して開くように屈曲されて弾支する弾性支持部を有する各1対のクランプアームと、
     前記第1のシャフト部に前進/後退自在に外嵌され、後端に把持部が設けられた中空長尺の第2のシャフト部の先端部が前進して前記弾性支持部を外側から押圧することにより前記各1対のクランプアームを縮径方向に閉じ、その先端部が前記弾性支持部から後退することにより前記各1対のクランプアームを拡径方向に開くクランプアーム開閉管と、を備えることを特徴とする請求項20記載の椎体間固定外科手術用椎体間スペース保持装置。
    The vertebral body clamping mechanism is
    Each of the fixed claws is connected to the distal end, and the rear end portion is connected to the distal end of the first shaft portion. In the free state, the fixed claws are expanded and opened in the orthogonal plane of the vertebral body. A pair of clamp arms each having an elastic support portion that is bent and elastically supported,
    A distal end portion of a hollow long second shaft portion that is externally fitted to the first shaft portion so as to be able to move forward / backward and a grip portion is provided at the rear end moves forward to press the elastic support portion from the outside. Each of the pair of clamp arms is closed in the diameter-reducing direction, and a clamp arm opening and closing tube that opens the pair of clamp arms in the diameter-expanding direction by retreating the tip of the pair from the elastic support portion. The interbody space holding device for interbody fusion surgery according to claim 20.
  22.  前記椎体クランプ機構は、
     先端に前記各固定爪が連設され、後端部が前記第1のシャフト部の先端部に第1の支持軸を介して前記椎体の直交面内で揺動自在に枢着された各1対のクランプアームと、
     前記第1のシャフト部に前進/後退自在に外嵌され、後端に把持部が設けられた中空長尺の第2のシャフト部と、
     前記各1対のクランプアームの中間部に第2の支持軸を介してそれぞれ一端部が揺動自在に枢着されるとともに、その各他端部が前記第2のシャフト部の先端部に第3の支持軸を介して揺動自在に枢着された各1対のリンク部材と、からなり、
     前記第2のシャフト部が前進又は後退することにより前記各1対のリンク部材を前記第3の支持軸を支点として反時計回り又は時計回りに揺動させて前記各1対のクランプアームを前記椎体の直交面内で前記第1の支持軸を支点として縮径方向に閉じ又は拡径方向に開くトグル機構を構成することを特徴とする請求項20記載の椎体間固定外科手術用椎体間スペース保持装置。
    The vertebral body clamping mechanism is
    Each fixing claw is connected to the distal end, and the rear end is pivotally attached to the distal end of the first shaft portion via a first support shaft so as to be swingable in an orthogonal plane of the vertebral body. A pair of clamp arms;
    A hollow long second shaft portion that is externally fitted to the first shaft portion so as to be movable forward / backward, and a grip portion is provided at the rear end;
    One end of each pair of clamp arms is pivotally attached to a middle portion of the pair of clamp arms via a second support shaft, and each other end thereof is connected to the tip of the second shaft portion. A pair of link members pivotably supported via three support shafts,
    As the second shaft portion moves forward or backward, the pair of link members are swung counterclockwise or clockwise with the third support shaft as a fulcrum, so that the pair of clamp arms are 21. The intervertebral fusion surgical vertebra according to claim 20, wherein a toggle mechanism is configured to close in the diameter reducing direction or open in the diameter expanding direction with the first support shaft as a fulcrum in an orthogonal plane of the vertebral body. Interbody space holding device.
  23.  前記固定爪の椎体挟持面に前記椎体の側面に突刺可能な複数の尖鋭突起を有することを特徴とする請求項20乃至請求項22のいずれか1項記載の椎体間固定外科手術用椎体間スペース保持装置。 The intervertebral fusion surgery according to any one of claims 20 to 22, wherein the vertebral body clamping surface of the fixed claw has a plurality of sharp protrusions that can be inserted into the side surface of the vertebral body. Interbody space holding device.
  24.  生体の椎体間固定外科手術の際に、2つの隣接する椎体(椎骨)間の適正な間隔を修正して椎間板スペースを保持するための装置であって、
     後端に把持部が設けられ、生体腹部側に設けられた内視鏡用腹腔部内のカニューレを介して前記椎体の前面近傍まで挿入される中空長尺の第1のシャフト部と、
     該第1のシャフト部の外面に軸方向に沿って回転自在に延設され、先端に形成されたねじ部が前記隣接する椎体の一方又は両方の前面部に羅入し固定される長尺固定ねじ部材と、
     前記第1のシャフト部の先端部に突設され、前記隣接する椎体の一方又は両方の前面部に突刺可能な一つ又は複数の針状突起と、を備えることを特徴とする椎体間固定外科手術用椎体間スペース保持装置。
    A device for correcting the proper spacing between two adjacent vertebral bodies (vertebrae) to preserve disc space during living interbody fusion surgery,
    A hollow long first shaft portion that is provided to the vicinity of the front surface of the vertebral body through a cannula in the abdominal portion for endoscope provided on the living body abdominal portion side with a gripping portion at the rear end;
    A long length that is rotatably extended along the axial direction on the outer surface of the first shaft portion, and a screw portion formed at the tip is inserted into and fixed to one or both front portions of the adjacent vertebral bodies. A fixing screw member;
    One or a plurality of needle-like protrusions projecting from the distal end of the first shaft portion and capable of being stabbed into one or both front surfaces of the adjacent vertebral bodies Interbody space retention device for fixed surgery.
  25.  前記第1のシャフト部の先端部に前記椎体の外径より僅かに狭い間隔で前記椎体間スペースに向かい軸方向に沿って対向状態で延設され、先端部から前記椎間板スペース内に挿入されることにより前記隣接する椎体を適正な間隔に修正して保持するような外形形状に形成された少なくとも1対のスペーサーをさらに備えることを特徴とする請求項20乃至請求項24のいずれか1項記載の椎体間固定外科手術用椎体間スペース保持装置。 The distal end portion of the first shaft portion extends in a state of being opposed to the intervertebral space at an interval slightly narrower than the outer diameter of the vertebral body along the axial direction, and is inserted into the intervertebral disc space from the distal end portion. 25. The apparatus according to claim 20, further comprising at least one pair of spacers formed in an outer shape so as to correct and hold the adjacent vertebral bodies at appropriate intervals. The interbody space holding device for interbody fusion surgery according to claim 1.
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