CA2259907A1 - Intramedullary, flexible fracture fixation device, using bi-axial prestressing - Google Patents
Intramedullary, flexible fracture fixation device, using bi-axial prestressing Download PDFInfo
- Publication number
- CA2259907A1 CA2259907A1 CA002259907A CA2259907A CA2259907A1 CA 2259907 A1 CA2259907 A1 CA 2259907A1 CA 002259907 A CA002259907 A CA 002259907A CA 2259907 A CA2259907 A CA 2259907A CA 2259907 A1 CA2259907 A1 CA 2259907A1
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- Canada
- Prior art keywords
- tendon
- prestressing
- anchor
- bone
- elements
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7216—Intramedullary pins, nails or other devices for bone lengthening or compression
- A61B17/7225—Intramedullary pins, nails or other devices for bone lengthening or compression for bone compression
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
- A61B17/7266—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/74—Devices for the head or neck or trochanter of the femur
- A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
- A61B17/746—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck the longitudinal elements coupled to a plate opposite the femoral head
Abstract
The invention refers to a prosthetic device for the application of simultaneous axial and tranversal prestressing to obtain stable and elastic osteosynthesis of fractures. The device focuses on the concept of internal fixation with consideration for the natural frequency of the bone. The device for fracture fixation comprises a "tendon" (i.e. a tensionable wire) least one deformable element at the focus of the fracture, with the tendon and the deformable element being disposed almost parallel, whereby the device further comprises compression means to apply a compression force to the deformable element(s), so that the deformable element(s) deform(s) laterally. The device described can be used for fractures of long bones as well as for proximal femoral fractures. When used for long bone fractures, the device is an intramedullar flexible bar, with which we apply adjustable and measurable axial prestressing in order to compress the bone fragments and preload the bone. When used for proximal femoral fractures, the device is the same intramedullar flexible bar, with which we apply adjustable and measuring lateral prestressing while anchoring it on the femoral shaft exterior. By doing so we compress the bone fragments in order to neutralize the tension forces on the fracture and to avoid interfragmentary motions. The terms "axial prestressing" and "lateral prestressing" refer to axis of the long bone. The device allows us to achieve predetermined and measurable intramedullar transversal prestressing, which is a prerequisite for the application of axial prestressing.
Description
CA 022~9907 1999-01-07 Intramedullary, Flexible F-acture Fixation Device, using bi-axial prestressing.
The invention refers to a prosthetic device for the application of simultaneous axial and transversal prestressing to preload the bone and obtain stable and elastic 5 osteosynthesis of fractures. The device focuses on the concept of biological internal fixation with minimal damage and with consideration for the natural frequency (Hz) of the bone.
Each of the well est-~l'shed flxation methods (rigid compression plating, reamed l0 intramedullary nailing, with or without interlocking of the fracture fragments, external fixation and dynamic hip screw) has advantagles and disadvantages as well as special t: ~mechanical characteristics. Vast clinical experience combined wHh the data produced from theorelical and experimental studies have described many of the problems related to the t' ~ .,echanics of these fracture fixation devices.
lS
Today's understanding of bone biology has led us to a new appruacl~ to bone fixation.
This app,uach considers the i""~o,Iance of thle preservation of the soft tissue and of careful protection of the viability of bone.
This invention aims to add to the theory and pr~lice of bone fixation the concept that 20 the fracture fixation device introduces into the broken bone equilibrium tensions to restore the intraosseous forces and make tlhe bone c~p~hlc of receiving the load stresses and muscle-spasm stresses right at the beginning of the healing period, as opposed tothe priorconcept that it is the device that receives these stresses.
A first attempt towards these goals is ~isclosed by Protogirou in WO 91/19461 (title:
Device for Osteosynthesis with Axially Guided Prestressing Elements). This device was also trying to solve some of the problems related to the biomechanics of bone fixation using axial prestressing to achieve stable ancl elastic osteosynthesis thus restoring the SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 intraosseous forces. The resetting of the fragments remains stable by the medullary guide and the axial prestressing is applied through the tendons.
According to the invention the device for fracture fixation comprises, a tendon and at 5 least a deformable element at the focus of the fracture, whereby the defo""able elements may be 2, 3, 4, 5, or more, with the tendon and the defo~mable element being disposed almost along the same direction, whereby the device further comprises compression means to apply a compression force to the deformable elements, so that the deformable elements deforms laterally. The device described can be used for 10 fractures of long bones as well as for proxin,al femoral fractures. When used for long bone fractures, the device is an intramedullar flexible bar, by which we apply adjustable and readable axial prestressing in order to compress the bone fragments and preload the bone, and not a supportive intramedullar nail as the devices used sofar for fracture fixation. When used for proAi,llal femoral fractures, the device is the same intramedullar 15 flexible bar, by which we apply Adjust~hle and readable lateral prestressing when anchoring it on the external femoral shafl. By doing so we compress the bone fragments in order to neutralize the tension forces on the fracture and to avoid the interfragmentary motions. The terms "axial prestressing" and "lateral prestressing" refer to the axis of the long bone.
The device according to the invention presents a different approach to the problem of fracture fixation in that it allows us to achieve predetermined and reAdAhl- intramedular transversal prestressing, which is a prerequisite for the application either of axial prestressing or of lateral prestressing. The transversal prestressing holds in place the reposilioned bone fragments and contributes to the neutr~ Ation of the bending moments and the shearing forces between the fracture angle and the mechanical axis of the bone caused by the axial prestressing in the case of long bone fractures. In the case of proximal femoral fractures the transversal prestressing diminishes the SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 interfragmentary motions. The term "transversal prestressing" refers to the "axial prestressing" and the "lateral prestressing" and is vertical to them.
Moreover, because the transversal prestressincl can diminish the bending moments and 5 the shearing forces caused by muscular spasm, the same device can be used as bone distractor for unstable long bone fractures.
The ability to compress the bone ends uniforml!/~ In the case of long bone fractures, can be achieved through intramedullary axial presitressing. But the fractured bone cannot 10 receive compression forces if it is not repositioned in a stable way, because of bending and shearing forces occurring as a result of compression. The resetting of the fragments remains stable and allows for the apl~ 'ion of axial prestressing because of - the prior arF' ~~'ion of intramedullary transversal prestressing. In order to achieve this bi-axial prestressing we need a tendon, inserled i"l.~r"edullarly and anchored in the 15 one end of the bone. The tendon is passing through cylindrical bodies, which ft into one another and form a flexible bar. At least one p.air of cylindrical bodies bear allach."ent means for defor."~ble elements. By applying compression to the cylinders by the compression nut we bring the cylinders together and compress the defor"~able elements, which deform laterally and exercise pressure on the inner wall of the bone (transversal prestressing). As the tendon is already anchored in the one end of the bone, we exercise tension on the tendon by a screw bolt with support on an anchor means, which is anchored into the other end of the bone (axial prestressing). In spite of the applir~'ion of tension, the flexible bar does not become a straight bar, but on the contrary it follows all the curvatures of the bone.
The neutr~'~tion of tension forces on the fractured proximal femoral bone can be achieved through lateral prestressing (tension band). The application of lateral prerstressing becomes more efficient if we dimlinish the interfragmentary motions. This SUBSTITUTE SHEET (IRULE 26) CA 022~9907 1999-01-07 W O 98/01077 . PCT/GR97/00026 is achieved by the prior application of transversal prestressing. In order to achieve this double prestressing we need an anchor screw, which is anchored in the head of the femur. The other end of this anchor screw is formed as a cylinder with aUachment means at both its ends for the deformable elements. By applying compression to a 5 compression means at the end of the cylinder other than the end bearing the screw, we compress the deforlllable elements, which deform laterally and exercise pressure on the inner wall of the bone (transversal prestressing). The one end of the tendon is anchored at the end of the cylinder other than the end bearing the screw. The tendon is anchored by a ball means in order to form an articulation at this point and thus diminish 10 the motion between implant and bone. The tendon bends on the lateral femoral shaft with support on a fulcrum attached on a plate, which plate is screwed in the lateral femoral shaft. The other end of the tendon passes through a cylinder fixed to the plate.
We exercise tension on this end of the tendon with support on the cylinder fixed to the plate and we then anchor the tendon on the plate (lateral prestressing). In some cases 15 of unstable fractures we add to the above described device a second tension band (wire). We introduce both ends of the wire in the form of a slip knot into the bone from the opening made for the anchor means 2b, towards the base of the femoral neck. We then anchor the slip knot on the anchor screw, we tighten it over the greater trochanter, and we then anchor both its ends on the plate.
The fol'~ ;"g advantages can be observed co"~pared with the previous fixation methods (rigid compression plating, reamed intramedullary nailing with or without interlocking of the fragments, external fixation and dynamic hip screw): -- The resetting of the fragments is supported by the transversal prestressing.
25 - One does not have to operate at the fracture area because the device is inserted intramedullary by the same technique as any intramedullary nail in the cases of long bone fractures, and it is inserted from the lateral femoral shaft by the same technique as the present devices in the cases of proximal femur fractures.
SUBSTITUTESHEET(RULE26) CA 022~9907 1999-01-07 - The device is introduced without any reaming, and fills up the intramedullar area, thus allowing for early bearing.
- The device is inserted easily and it does not affect the shape of the bone because it is flexible and self guided and follows the cun/es of the bone.
5 - Friction between device and bone is minimal because of small and firm contact between them.
- The infection possibilHy and other complications are minimised.
- The time of medical attendance and recovery is minimised.
- The removal of the device is very easy.
lO - Moreover, because the transversal prestressing can neutralise the bending moments and the shearing forces caused by muscular spasm, the same device can be used as bone di;,lra-,tor for unstable fractures.
- The possible mistakes are very few because the method is easy to learn and apply.
- The use of x-rays is not necess~ry in many a~ses, and when indispensable, the time 15 of use is minimked.
- The device does not affect the E-modulus and the blood circulation of the bone.
- It is possible to assemble individual device components of different lengths, so as to achieve adjustment accG,d;"g to the geomel:ry of the specific bone (Universal and Modular).
The present invention wiO be better understood with the following detailed description of an embodiment for each type of fracture, long bone and proximal femur frahure, in connection with the accGn,panying drawings:
25 FIGURE 1 is a representation of the device implanted into a femur bone.
FIGURE 2 is a representation of the bolt 11.
FIGURE 3 is a representation of the anchor means 12.
FIGURE 4 is a representation of the nut 10.
SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 FIGURE 5 is a representation of the tendon 1 with anchor means 2 at its one end and screw means 2a at its other end.
FIGURE 6 is a representation of torque means 5.
FIGURE 7 is a representation of a cylindrical element 3.
5 FIGURE 8 is a representation of the two cylindrical elements 6 and 7 and of the deformable element 9.
FIGURE 9 is a representation of the device implanted into a proximal femur bone.
FIGURE 10 is a representation of the anchor means 2b.
FIGURE 11 is a representation of a bolt 18.
lO FIGURE 12 is a representation of the end of the tendon 1b which end is formed as a ball.
FIGURE 13 is a representation of the defor,nable elements 9b attached to the ~t(achr"ent means 8b.
FIGURE 14 is a represenldIion of the plate 14 with the cylinder 16.
15 FIGURE 15 is a ,~presen~lion of the protrusion 15 which is attached to the head of the plate 14.
FIGURE 16 is a section of the plate 14.
. ' Referring now to the drawings the f~l ~; ,g detailed desc,i~Jtion of two embodiments 20 one for a long bone fracture and one for a PrUA;IIIal femur fracture will help understand how we apply the above mentioned principle of bi-axial prestressing.
The tendon 1 for the application of axial prestressing can be a wire-cable. Its one end is incorporated into an anchor means 2 which may be a self-taping screw suitable for 25 spongy bone. The head of the anchor means is cylindrical with two slots 4, dividing the perimeter of the cylinder into two protrusions which fit into the two slots of the preceding cylindrical body 3. The other end of the tendon is incor~oraled into a screw means 2a for example a threaded bar.
SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 The tendon is passing through cylinders. We have three kinds of cylinders depending on their position on the device and their use. All the cylinders except the last one 5 towards the end of the device near the body have two opposite facing slots 4 at both 5 their ends, dividing the perimeter of the cylindler into two protrusions which fit into the two slots of the nearby cylinder, so as to allow the cylinders first to fit into one another and form a flexible bar, and second to transmit the torsion force which we apply on the torque means 5 to the anchor means 2.
l O The two cylinders 6, 7, which correspond to the focus of the fracture, have an overdrawn perimeter for part of their length, to provide place for attachment means 8, in which the defonnable laminated springs 9 are aldapted. The length of the slots of these two cylinders on the end where they fit into one another is longer, so as to allow them to come closer, compress the laminated springs and let them bow and exercise 15 i,ll,d",eclullary pressure.
The torque means 5, placed last towards the end of the device near the body is of similar shape to the cylinders 3 along half of its length. The other half of its length, towards the end of the device, has the shape of a screw nut as regards its extemal 20 shape. A nut screwdriver is adapted to this half of the torque means 5 to screw the anchor means 2, by screwing the whole device around itself. The internal cylindrical opening of the part of the torque means 5 whic;h fits into the cylinder 3 is of the same diameter as the openings of all the other cylinders so as to allow the tendon to pass through, whereas the part of the internal openinq towards the end of the device is larger 25 to let the threaded bar 2a adapted to the tendon fit into it and be stopped there so as to hold all the cylinders together.
SU~ JTE SHEET (RIJLE 26) CA 022~9907 lgg9-ol-o7 A nut 10 is screwed around the threaded bar 2ato bring all the cylindrical bodies 3,6,7 and torque means 5 together and compress laminated springs 9, which by deforming laterally, exercise intramedullar pressure, i.e. transversal prestressing.
5 The bolt 11 is then screwed around the bar 2a after the nut 10, to apply tension to the tendon 1 with support on the anchor means 12 and on the bone, thus exercising axial prestressing, that is pre-loading of the bone.
Bolt 11 may be replaced by element 11a with grooves on its outer side. In this case the 10 element 11a when screwed inside the anchor means 12 and by compressing the bar 2a, it applies compression forces to the device, thus di~lld~;ting the bone fragments when necessary.
The tendon 1b for the ar,~l e-'ion of latetal prestressing can be a wire cable. Its one 15 end may have the form of a ball which is attached to a bolt 18, which boH is screwed around torque means 5b. Torque means 5b is actually the one end of an anchor means 2b, and serves to screw the anchor means into the bone. The other end of the anchor means 2b may be a self-taping screw, suit~le for spongy bone. The body of the anchor means 2b is hollow ber~use the anchor means is posHioned wHh the help of a drill guide. Around the cylindrical part of anchot means 2b defor")akle elements 9b are disposed almost along the same direction, which are fixed at both their ends into ~llach",ent means 8b. Before screwing bolt 18 around the one end of anchor means 2b, we screw a nut 10b, which compresses the attachment means 8b-between eachother, thus deforming the defo~mable elements 9b laterally. The defor"l-''e elements 9b fill up the Ward's Triangle and exercise pressure on the inner side of the bone (transversal prestressing).
SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 - W 098tO1077 PCT/GR97/00026 A plate 14 is fixed with screws on the lateral cortex of the femur. This plate differs from the usual ones in two points. First it has a protrusion 15 on its head, which se~ves as a fulcrum for the tendon 1b to have a smooth change of direction of the tendon. Second, there is a cylinder 16 fixed on the plate' s bodll/ The tendon 1b is passing through this 5 cylinder.
We exercise tension (lateral prestressing) on the tendon along its axis, with support -against the cylinder 16. This tension may be easily measured and adjusted according to '' the necessities of the direction of the fracture, the weight of the patient and the form, dimensions and quality of the bone. This tension can be applied by means of a ,~
lO dyna,no,nellic tensioner, which in this case pla!~s the role of a tension means. We then ~r anchor the tendon on the plate with a securing means 17. This securing means 17 may be in the forrn of a defo,-,~F'lE metal clip or cylinder, which can be deformed and pressed on the tendon in a fixed relationship.
SUBSTITUTESHEET~RULE26)
The invention refers to a prosthetic device for the application of simultaneous axial and transversal prestressing to preload the bone and obtain stable and elastic 5 osteosynthesis of fractures. The device focuses on the concept of biological internal fixation with minimal damage and with consideration for the natural frequency (Hz) of the bone.
Each of the well est-~l'shed flxation methods (rigid compression plating, reamed l0 intramedullary nailing, with or without interlocking of the fracture fragments, external fixation and dynamic hip screw) has advantagles and disadvantages as well as special t: ~mechanical characteristics. Vast clinical experience combined wHh the data produced from theorelical and experimental studies have described many of the problems related to the t' ~ .,echanics of these fracture fixation devices.
lS
Today's understanding of bone biology has led us to a new appruacl~ to bone fixation.
This app,uach considers the i""~o,Iance of thle preservation of the soft tissue and of careful protection of the viability of bone.
This invention aims to add to the theory and pr~lice of bone fixation the concept that 20 the fracture fixation device introduces into the broken bone equilibrium tensions to restore the intraosseous forces and make tlhe bone c~p~hlc of receiving the load stresses and muscle-spasm stresses right at the beginning of the healing period, as opposed tothe priorconcept that it is the device that receives these stresses.
A first attempt towards these goals is ~isclosed by Protogirou in WO 91/19461 (title:
Device for Osteosynthesis with Axially Guided Prestressing Elements). This device was also trying to solve some of the problems related to the biomechanics of bone fixation using axial prestressing to achieve stable ancl elastic osteosynthesis thus restoring the SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 intraosseous forces. The resetting of the fragments remains stable by the medullary guide and the axial prestressing is applied through the tendons.
According to the invention the device for fracture fixation comprises, a tendon and at 5 least a deformable element at the focus of the fracture, whereby the defo""able elements may be 2, 3, 4, 5, or more, with the tendon and the defo~mable element being disposed almost along the same direction, whereby the device further comprises compression means to apply a compression force to the deformable elements, so that the deformable elements deforms laterally. The device described can be used for 10 fractures of long bones as well as for proxin,al femoral fractures. When used for long bone fractures, the device is an intramedullar flexible bar, by which we apply adjustable and readable axial prestressing in order to compress the bone fragments and preload the bone, and not a supportive intramedullar nail as the devices used sofar for fracture fixation. When used for proAi,llal femoral fractures, the device is the same intramedullar 15 flexible bar, by which we apply Adjust~hle and readable lateral prestressing when anchoring it on the external femoral shafl. By doing so we compress the bone fragments in order to neutralize the tension forces on the fracture and to avoid the interfragmentary motions. The terms "axial prestressing" and "lateral prestressing" refer to the axis of the long bone.
The device according to the invention presents a different approach to the problem of fracture fixation in that it allows us to achieve predetermined and reAdAhl- intramedular transversal prestressing, which is a prerequisite for the application either of axial prestressing or of lateral prestressing. The transversal prestressing holds in place the reposilioned bone fragments and contributes to the neutr~ Ation of the bending moments and the shearing forces between the fracture angle and the mechanical axis of the bone caused by the axial prestressing in the case of long bone fractures. In the case of proximal femoral fractures the transversal prestressing diminishes the SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 interfragmentary motions. The term "transversal prestressing" refers to the "axial prestressing" and the "lateral prestressing" and is vertical to them.
Moreover, because the transversal prestressincl can diminish the bending moments and 5 the shearing forces caused by muscular spasm, the same device can be used as bone distractor for unstable long bone fractures.
The ability to compress the bone ends uniforml!/~ In the case of long bone fractures, can be achieved through intramedullary axial presitressing. But the fractured bone cannot 10 receive compression forces if it is not repositioned in a stable way, because of bending and shearing forces occurring as a result of compression. The resetting of the fragments remains stable and allows for the apl~ 'ion of axial prestressing because of - the prior arF' ~~'ion of intramedullary transversal prestressing. In order to achieve this bi-axial prestressing we need a tendon, inserled i"l.~r"edullarly and anchored in the 15 one end of the bone. The tendon is passing through cylindrical bodies, which ft into one another and form a flexible bar. At least one p.air of cylindrical bodies bear allach."ent means for defor."~ble elements. By applying compression to the cylinders by the compression nut we bring the cylinders together and compress the defor"~able elements, which deform laterally and exercise pressure on the inner wall of the bone (transversal prestressing). As the tendon is already anchored in the one end of the bone, we exercise tension on the tendon by a screw bolt with support on an anchor means, which is anchored into the other end of the bone (axial prestressing). In spite of the applir~'ion of tension, the flexible bar does not become a straight bar, but on the contrary it follows all the curvatures of the bone.
The neutr~'~tion of tension forces on the fractured proximal femoral bone can be achieved through lateral prestressing (tension band). The application of lateral prerstressing becomes more efficient if we dimlinish the interfragmentary motions. This SUBSTITUTE SHEET (IRULE 26) CA 022~9907 1999-01-07 W O 98/01077 . PCT/GR97/00026 is achieved by the prior application of transversal prestressing. In order to achieve this double prestressing we need an anchor screw, which is anchored in the head of the femur. The other end of this anchor screw is formed as a cylinder with aUachment means at both its ends for the deformable elements. By applying compression to a 5 compression means at the end of the cylinder other than the end bearing the screw, we compress the deforlllable elements, which deform laterally and exercise pressure on the inner wall of the bone (transversal prestressing). The one end of the tendon is anchored at the end of the cylinder other than the end bearing the screw. The tendon is anchored by a ball means in order to form an articulation at this point and thus diminish 10 the motion between implant and bone. The tendon bends on the lateral femoral shaft with support on a fulcrum attached on a plate, which plate is screwed in the lateral femoral shaft. The other end of the tendon passes through a cylinder fixed to the plate.
We exercise tension on this end of the tendon with support on the cylinder fixed to the plate and we then anchor the tendon on the plate (lateral prestressing). In some cases 15 of unstable fractures we add to the above described device a second tension band (wire). We introduce both ends of the wire in the form of a slip knot into the bone from the opening made for the anchor means 2b, towards the base of the femoral neck. We then anchor the slip knot on the anchor screw, we tighten it over the greater trochanter, and we then anchor both its ends on the plate.
The fol'~ ;"g advantages can be observed co"~pared with the previous fixation methods (rigid compression plating, reamed intramedullary nailing with or without interlocking of the fragments, external fixation and dynamic hip screw): -- The resetting of the fragments is supported by the transversal prestressing.
25 - One does not have to operate at the fracture area because the device is inserted intramedullary by the same technique as any intramedullary nail in the cases of long bone fractures, and it is inserted from the lateral femoral shaft by the same technique as the present devices in the cases of proximal femur fractures.
SUBSTITUTESHEET(RULE26) CA 022~9907 1999-01-07 - The device is introduced without any reaming, and fills up the intramedullar area, thus allowing for early bearing.
- The device is inserted easily and it does not affect the shape of the bone because it is flexible and self guided and follows the cun/es of the bone.
5 - Friction between device and bone is minimal because of small and firm contact between them.
- The infection possibilHy and other complications are minimised.
- The time of medical attendance and recovery is minimised.
- The removal of the device is very easy.
lO - Moreover, because the transversal prestressing can neutralise the bending moments and the shearing forces caused by muscular spasm, the same device can be used as bone di;,lra-,tor for unstable fractures.
- The possible mistakes are very few because the method is easy to learn and apply.
- The use of x-rays is not necess~ry in many a~ses, and when indispensable, the time 15 of use is minimked.
- The device does not affect the E-modulus and the blood circulation of the bone.
- It is possible to assemble individual device components of different lengths, so as to achieve adjustment accG,d;"g to the geomel:ry of the specific bone (Universal and Modular).
The present invention wiO be better understood with the following detailed description of an embodiment for each type of fracture, long bone and proximal femur frahure, in connection with the accGn,panying drawings:
25 FIGURE 1 is a representation of the device implanted into a femur bone.
FIGURE 2 is a representation of the bolt 11.
FIGURE 3 is a representation of the anchor means 12.
FIGURE 4 is a representation of the nut 10.
SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 FIGURE 5 is a representation of the tendon 1 with anchor means 2 at its one end and screw means 2a at its other end.
FIGURE 6 is a representation of torque means 5.
FIGURE 7 is a representation of a cylindrical element 3.
5 FIGURE 8 is a representation of the two cylindrical elements 6 and 7 and of the deformable element 9.
FIGURE 9 is a representation of the device implanted into a proximal femur bone.
FIGURE 10 is a representation of the anchor means 2b.
FIGURE 11 is a representation of a bolt 18.
lO FIGURE 12 is a representation of the end of the tendon 1b which end is formed as a ball.
FIGURE 13 is a representation of the defor,nable elements 9b attached to the ~t(achr"ent means 8b.
FIGURE 14 is a represenldIion of the plate 14 with the cylinder 16.
15 FIGURE 15 is a ,~presen~lion of the protrusion 15 which is attached to the head of the plate 14.
FIGURE 16 is a section of the plate 14.
. ' Referring now to the drawings the f~l ~; ,g detailed desc,i~Jtion of two embodiments 20 one for a long bone fracture and one for a PrUA;IIIal femur fracture will help understand how we apply the above mentioned principle of bi-axial prestressing.
The tendon 1 for the application of axial prestressing can be a wire-cable. Its one end is incorporated into an anchor means 2 which may be a self-taping screw suitable for 25 spongy bone. The head of the anchor means is cylindrical with two slots 4, dividing the perimeter of the cylinder into two protrusions which fit into the two slots of the preceding cylindrical body 3. The other end of the tendon is incor~oraled into a screw means 2a for example a threaded bar.
SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 The tendon is passing through cylinders. We have three kinds of cylinders depending on their position on the device and their use. All the cylinders except the last one 5 towards the end of the device near the body have two opposite facing slots 4 at both 5 their ends, dividing the perimeter of the cylindler into two protrusions which fit into the two slots of the nearby cylinder, so as to allow the cylinders first to fit into one another and form a flexible bar, and second to transmit the torsion force which we apply on the torque means 5 to the anchor means 2.
l O The two cylinders 6, 7, which correspond to the focus of the fracture, have an overdrawn perimeter for part of their length, to provide place for attachment means 8, in which the defonnable laminated springs 9 are aldapted. The length of the slots of these two cylinders on the end where they fit into one another is longer, so as to allow them to come closer, compress the laminated springs and let them bow and exercise 15 i,ll,d",eclullary pressure.
The torque means 5, placed last towards the end of the device near the body is of similar shape to the cylinders 3 along half of its length. The other half of its length, towards the end of the device, has the shape of a screw nut as regards its extemal 20 shape. A nut screwdriver is adapted to this half of the torque means 5 to screw the anchor means 2, by screwing the whole device around itself. The internal cylindrical opening of the part of the torque means 5 whic;h fits into the cylinder 3 is of the same diameter as the openings of all the other cylinders so as to allow the tendon to pass through, whereas the part of the internal openinq towards the end of the device is larger 25 to let the threaded bar 2a adapted to the tendon fit into it and be stopped there so as to hold all the cylinders together.
SU~ JTE SHEET (RIJLE 26) CA 022~9907 lgg9-ol-o7 A nut 10 is screwed around the threaded bar 2ato bring all the cylindrical bodies 3,6,7 and torque means 5 together and compress laminated springs 9, which by deforming laterally, exercise intramedullar pressure, i.e. transversal prestressing.
5 The bolt 11 is then screwed around the bar 2a after the nut 10, to apply tension to the tendon 1 with support on the anchor means 12 and on the bone, thus exercising axial prestressing, that is pre-loading of the bone.
Bolt 11 may be replaced by element 11a with grooves on its outer side. In this case the 10 element 11a when screwed inside the anchor means 12 and by compressing the bar 2a, it applies compression forces to the device, thus di~lld~;ting the bone fragments when necessary.
The tendon 1b for the ar,~l e-'ion of latetal prestressing can be a wire cable. Its one 15 end may have the form of a ball which is attached to a bolt 18, which boH is screwed around torque means 5b. Torque means 5b is actually the one end of an anchor means 2b, and serves to screw the anchor means into the bone. The other end of the anchor means 2b may be a self-taping screw, suit~le for spongy bone. The body of the anchor means 2b is hollow ber~use the anchor means is posHioned wHh the help of a drill guide. Around the cylindrical part of anchot means 2b defor")akle elements 9b are disposed almost along the same direction, which are fixed at both their ends into ~llach",ent means 8b. Before screwing bolt 18 around the one end of anchor means 2b, we screw a nut 10b, which compresses the attachment means 8b-between eachother, thus deforming the defo~mable elements 9b laterally. The defor"l-''e elements 9b fill up the Ward's Triangle and exercise pressure on the inner side of the bone (transversal prestressing).
SUBSTITUTE SHEET (RULE 26) CA 022~9907 1999-01-07 - W 098tO1077 PCT/GR97/00026 A plate 14 is fixed with screws on the lateral cortex of the femur. This plate differs from the usual ones in two points. First it has a protrusion 15 on its head, which se~ves as a fulcrum for the tendon 1b to have a smooth change of direction of the tendon. Second, there is a cylinder 16 fixed on the plate' s bodll/ The tendon 1b is passing through this 5 cylinder.
We exercise tension (lateral prestressing) on the tendon along its axis, with support -against the cylinder 16. This tension may be easily measured and adjusted according to '' the necessities of the direction of the fracture, the weight of the patient and the form, dimensions and quality of the bone. This tension can be applied by means of a ,~
lO dyna,no,nellic tensioner, which in this case pla!~s the role of a tension means. We then ~r anchor the tendon on the plate with a securing means 17. This securing means 17 may be in the forrn of a defo,-,~F'lE metal clip or cylinder, which can be deformed and pressed on the tendon in a fixed relationship.
SUBSTITUTESHEET~RULE26)
Claims (17)
1. Device for fracture fixation comprising at least one deformable element (9) and compression means (10,2a) to apply a compression force to the deformable element, so that the elongated deformable element deforms laterally, characterized in that the device further comprises a) a tendon (1) having a first end and a second end opposite to the first end, b) anchor means (2) at the first end of the tendon, c) and tension means (11,12) co-acting with the anchor means (2) to apply a tension force to the tendon (1).
2. Device according to claim 1 comprising torque means (5,5b) to apply a torque to the anchor means (2,2b), to turn the device around itself by screwing the first anchor means (2,2b).
3. Device according to claim 1 or 2 whereby the tendon comprises screw means (2a) on its second end.
4. Device according to claim 3 comprising a plurality of cylindrical elements (3,5,6,7) disposed around the tendon (1), attachment means (8) on two cylindrical elements to attach the two ends of the deformable elements (9) to the two cylindrical elements, andcompression means (10) co-acting with the screw means (2a) at the second end of the tendon, so that when the compression (10) is screwed around the screw means (2a) the plurality of cylindrical elements are brought together to compress the deformable element (9), which by deforming laterally exercises intramedullary pressure transversal prestressing.
5. Device according to claim 1, comprising first anchor means (2,2b) at the first end of the tendon (1,1b) and torque means (5,5b) to apply a torque to the anchor means (2,2b), to turn the device around itself for screwing the first anchor means (2,2b).
6. Device according to claim 1, whereby the compression means comprise first anchor means (2) at the first end of the tendon (1) and screw means (2a) at the second end of the tendon, a plurality of cylindrical elements (3,5,6,7) disposed around the tendon (1), attachment means (8) on two cylindrical elements to attach the two ends of the deformable elements (9) to the two cylindrical elements, and compression means (10) co-acting with the screw means (2a), so that when the 10a compression means (10) is screwed around the screw means (2a) the plurality of cylindrical elements are brought together to compress the deformable element (9), which by deforming laterally, exercise intramedullary pressure transversal prestressing.
7. Device according to claim 1, whereby the deformable elements (9b) are fixed at both their ends onto attachment means (8b), coacting with the compression means (10b) to compress the deformable elements (9b) and deform them laterally.
8. Device according to claim 6, comprising a bolt means (11) and second anchor means (12) at the end of the tendon carrying the screw means, whereby the bolt means and the second anchor means co-act with the screw means (2a) to apply a tension force to the tendon.
9. Device according to any preceeding claim, further comprising a third anchor means (14,16) and a securing means (17) at the end of the tendon opposite to the first anchor means, whereby the anchor mrans (14,16) and the securing means (17) coact to maintain the tension force applied to the tendon.
10. Device according to claim 6, whereby at least two cylindrical elements have two slots (4) at both their ends, so that at each end of the cylindrical elements there are alternating protrusions and slots, to co-act with corresponding slots and protrusions of the adjacent cylindrical element, so as to allow the cylindrical elements to fit into one another and form a flexible bar.
11. Device according to claims 1, 4, or 5, further comprising a bolt (18) to be screwed around the one end of first anchor means (2b), whereby the first end of the tendon (1b) has the form of a ball enclosed within the bolt (18).
12. Device according to claim 10, whereby two cylindrical elements (6,7) have longer slots (4) on the end where they fit into one another, so as to allow them to come closer and compress the deformable elements.
13. Device according to claim 10, whereby the first anchor means (2) has a cylindrical head with slots (4), so as to fit in to the preceding cylindrical element (3).
14. Device according to any of the preceeding claims, with more than one deformable elements (9,9b), which deformable elements (9,9b) are positioned around the circumference of the anchor means (2,2b) parallel to one another.
15. Device according to any preceeding claim, whereby the third anchor means comprises a plate (14) and a cylinder (16) fixedly attached to the plate (14).
16. Device according to claims 9 and 15, whereby the plate (14) further comprises a protrusion (15) as a fulcrum for the tendon (1b).
17. Device according to any preceeding claim, whereby the whole part of the device, which is outside the bone is covered by a biocompatible plate to provide for a smooth external surface.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GR96100234 | 1996-07-10 | ||
GR960100234 | 1996-07-10 |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2259907A1 true CA2259907A1 (en) | 1998-01-15 |
Family
ID=10942443
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002259907A Abandoned CA2259907A1 (en) | 1996-07-10 | 1997-07-09 | Intramedullary, flexible fracture fixation device, using bi-axial prestressing |
Country Status (8)
Country | Link |
---|---|
US (1) | US6224600B1 (en) |
EP (1) | EP0921767B1 (en) |
JP (1) | JP2001509040A (en) |
AT (1) | ATE252347T1 (en) |
CA (1) | CA2259907A1 (en) |
DE (1) | DE69725736D1 (en) |
GR (1) | GR1003032B (en) |
WO (1) | WO1998001077A1 (en) |
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-
1996
- 1996-07-10 GR GR960100234A patent/GR1003032B/en not_active IP Right Cessation
-
1997
- 1997-07-09 DE DE69725736T patent/DE69725736D1/en not_active Expired - Lifetime
- 1997-07-09 WO PCT/GR1997/000026 patent/WO1998001077A1/en active IP Right Grant
- 1997-07-09 CA CA002259907A patent/CA2259907A1/en not_active Abandoned
- 1997-07-09 EP EP97929435A patent/EP0921767B1/en not_active Expired - Lifetime
- 1997-07-09 JP JP50495898A patent/JP2001509040A/en active Pending
- 1997-07-09 AT AT97929435T patent/ATE252347T1/en not_active IP Right Cessation
- 1997-07-09 US US09/214,600 patent/US6224600B1/en not_active Expired - Fee Related
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US6224600B1 (en) | 2001-05-01 |
EP0921767A1 (en) | 1999-06-16 |
JP2001509040A (en) | 2001-07-10 |
GR1003032B (en) | 1998-12-16 |
EP0921767B1 (en) | 2003-10-22 |
WO1998001077A1 (en) | 1998-01-15 |
DE69725736D1 (en) | 2003-11-27 |
ATE252347T1 (en) | 2003-11-15 |
GR960100234A (en) | 1998-03-31 |
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FZDE | Discontinued |