CN103417313A - Artificial intervertebral disc prosthesis - Google Patents

Artificial intervertebral disc prosthesis Download PDF

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Publication number
CN103417313A
CN103417313A CN2012101547613A CN201210154761A CN103417313A CN 103417313 A CN103417313 A CN 103417313A CN 2012101547613 A CN2012101547613 A CN 2012101547613A CN 201210154761 A CN201210154761 A CN 201210154761A CN 103417313 A CN103417313 A CN 103417313A
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China
Prior art keywords
sliding block
top shoe
sliding
arthroplasty
artificial disc
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CN2012101547613A
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CN103417313B (en
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朱悦
郝玉琳
吴亚俊
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First Hospital of China Medical University
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朱悦
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof

Abstract

An artificial intervertebral disc prosthesis is used for completely replacing an intervertebral disc of the cervical vertebra and an intervertebral disc of the lumbar vertebra. The artificial intervertebral disc prosthesis is composed of an upper sliding block (1) and a lower sliding block (2) or composed of the upper sliding block (1), the lower sliding block (2) and a middle sliding block (3), and for the previous situation, the upper sliding block (1) and the lower sliding block (2) are respectively provided with a sliding area used for match contact between the upper sliding block (1) and the lower sliding block (2); for the post situation, the middle sliding block (3) is arranged between the upper sliding block (1) and the lower sliding block (2) and is in contact fit with the upper sliding block (1) and the lower sliding block (2) to form a sliding area. According to the artificial intervertebral disc prosthesis, a completely smooth contact interface is provided for movement of the prosthesis, and long-time stable and smooth movement is guaranteed. The artificial intervertebral disc prosthesis will be made of novel titanium alloy and polyether-ether-ketone material, and therefore mechanical properties of the artificial intervertebral disc prosthesis are durable and stable. The artificial intervertebral disc prosthesis has obvious innovation and performance advantages in structural design and material selection, and has excellent application prospect in the field.

Description

A kind of artificial disc after arthroplasty
Technical field
The present invention relates to structural design and the applied technical field of orthopaedic medical treatment articles for use, provide especially a kind of for substituting the artificial disc after arthroplasty of the intervertebral disc of human cervical spine and/or lumbar vertebra fully.
Background technology
Because the intervertebral disc disorder of the cervical vertebra due to a variety of causes and lumbar vertebra has destroyed the integrity of intervertebral disc structure; make intervertebral disc lose the function of its original motion and bearing load; bring the symptoms such as pain, delayed ischemic neurological deficits to people, had a strong impact on people's daily routines.When the disc disease expectant treatment of cervical vertebra and lumbar vertebra is invalid, should carry out operative treatment.Operation method commonly used comprises intercalated disc resection of nucleus pulposus and disc excision bone graft fusion etc. at present, but no matter be proper motion and the bearing function that the former or the latter have all destroyed lesion segment, also changed the biomechanics state of adjacent segment intervertebral disc and other tissue simultaneously, caused the Adjacent segment degeneration aggravation, so its late result is all not good enough.
For the function of reconstruction of intervertebral disc, recover the physiological status of spinal column, people produce the thought of invention artificial disc after arthroplasty.A plurality of related-art technology such as scholars' bond material science, biomechanics and industrial design, carried out design and the application of many artificial disc after arthroplasties in recent decades.
Mainly should the load principle of the following aspects of at present artificial disc after arthroplasty design: one, material property: the body implant material is aspect biology, requirement must have good biocompatibility, avirulence, non-carcinogenesis, corrosion resistance, can not cause local tissue reaction after implantation, this is the basic demand of artificial disc after arthroplasty material.From the biomechanics aspect, consider, because intervertebral disc will bear the multiple loads such as compression, bending, torsion, shearing under physiological status, be the load activity axle center of FSU, so material also must have the performance conditions such as high strength, wearability, fatigue resistance.The soleplate part of artificial disc after arthroplasty contacts with the terminal plate of vertebral body sclerotin, and the elastic modelling quantity of its contact interface should mate as far as possible, and the elastic modelling quantity of soleplate part should be close with osseous tissue, could effectively avoid like this depression of implants and become flexible; Two, kinesiology: the motor function of the human intervertebral disc of normal configuration is very complicated, can on multiple directions, carry out motion simple or associating, and the spinal column of different segment, and its range of movement and conjugate movement characteristic are different.Should recover to replace the physiological activity performance of sections during the design artificial disc after arthroplasty as far as possible, be included in range of activity, axis of rotation on multiple directions, artificial disc after arthroplasty is synchronizeed with the spinal motion of contiguous a plurality of sections; Three, implants is fixing: fixedly comprising of artificial disc after arthroplasty is at once fixing and permanent fixing.At once the fixing machinery that adopts fixing more, by screw, hook, thorn, bolt etc. and sclerotin on every side chimeric obtain temporary transient fixing, at once fixing purpose is for the time fixedly is provided for a long time, if can not obtain effectively permanent fixing, at once fixing finally meeting failure, therefore obtain effectively fixing for a long time particularly important.The permanent soleplate part contact surface that is fixedly bone tissue growth by soleplate enters artificial disc after arthroplasty is realized, therefore the surface of the contact surface of soleplate up and down of prosthese need to be processed accordingly, comprise the screw thread processing, hydroxyapatite coating layer is processed, and the soleplate contact surface should be tried one's best greatly, so can realize firmly fixing for a long time; Four, safety: artificial disc after arthroplasty also should make safety easy for installation, operation wound little, be easy to remove and prosthese is overhauled.
Current existing kinds of artificial intervertebral disk prosthesis can be divided into artificial lumbar disc 3 kinds according to the difference of composition material: i.e. nonmetal, metal and both coalitions.
The major advantage of nonmetal prosthese is that mechanical performance is similar to human intervertebral disc, and its lower elastic modelling quantity is closer to the mechanical characteristic of intervertebral disc.Implant comprises one or more vertebral pulp and the fibrous ring of the elastic of cushioning effect with the imitation intervertebral disc that have.Lee etc. (referring to list of references 1Lee CK, Langrana NA, Parsons JR, et al.Development of a prosthetic intervertebral disc.Spine, 1991, 16:S253-255. referring to list of references 2 Vuono-Hawkins M, Langrana NA, Lee CK, et al.Materials and design concepts for an intervertebral disc spacer.II.Multidurometer composite design.J Appl Biomater.1995, 6:117-123.) designed a kind of nonmetal prosthese, its center is that soft rubber elastomer core is to imitate the vertebral pulp of intervertebral disc, periphery 6～15 layers of IR fiber band by different directions in order to imitate the function of fibrous ring, this prosthese can imitate the vertebral pulp of pressurized and the human intervertebral disc that pressurized reverses.But because the intensity of prosthetic material is limited, and lack the satisfied method that fixedly secures, this class nonmetallic materials artificial disc after arthroplasty is of limited application at present.
The advantage of metal material artificial lumbar disc is that it has good biocompatibility, high strength, resisting fatigue, resistance to wears, is easy to the performance advantages such as fixing are installed, and the metal material of selecting mainly contains rustless steel, titanium alloy, vitallium etc.But far away higher than human body bone, form heavily stressed distribution due to the elastic modelling quantity of metal prostheses material on the contact surface of artificial disc after arthroplasty and terminal plate of vertebral body, cause the depression of prosthese, this becomes the all-metal prosthese needs improvements.The disc replacement thing used first on human history is all-metal construction.Within 1966, Fernstrom(is referring to list of references 3Fernstrom U.Arthroplasty with intercorporal endoprothesis in herniated disc and in painfuldisc.Acta Chir Scand Suppl, 1966; 357:154-159.) be reported in after 125 routine cervical vertebras and lumbar discectomy the spherical prosthese of rustless steel of filling in diameter a 10～16mm, think in early days the effect of stabilizing spine and maintenance activity is arranged, but Follow-up After finds that the metal ball major part is absorbed in vertebral body in 4～7 years, only have 12% disc height to be maintained, and intervertebral can not be movable, and this design is abandoned.The material of Maverick all-metal artificial lumbar disc is cobalt-chromium-molybdenum alloy; adopt the high polish technology of artificial hip joint to make (referring to list of references 4Mathews HH; Lehuec JC; Friesem T; et al.Design rationale and biomechanics of Maverick Total Disc arthroplasty with early clinical results.Spine J, 2004; 4:268S-275S.).Prosthese comprises two parts, and global design designs for ball-and-socket joint, and it is qualified through laboratory, to detect, and, in the approval by U.S. FDA in 2003, has carried out clinical experimental study.By the follow-up investigation to 7 routine patients, find; short run effect obviously is better than using the patient of Invasive lumbar fusion device (referring to list of references 4 Mathews HH; Lehuec JC; Friesem T; et al.Design rationale and biomechanics of Maverick Total Disc arthroplasty with early clinical results.Spine J, 2004; 4:268S-275S.).The material of the FlexiCore all-metal artificial lumbar disc of another kind of cobalt-chromium-molybdenum alloy material is also; also the approval by U.S. FDA in 2003; carried out clinical experimental study (referring to list of references 5 Valdevit A; Errico TJ.Design and evaluation of the FlexiCore metal-on-metal intervertebral disc prosthesis.Spine J, 2004; 4:276S-288S.).This prosthese is combined closely and is formed by four parts, has designed a ball-and-socket joint between upper and lower cover plates, in its spherical slidingsurface, has little brake area in order to restricting rotation, and this prosthese can meet the lumbar vertebra range of activity, has limited again the over-activity of lumbar vertebra.
In order to bring into play the advantage of metal and nonmetallic materials, mutually make up the material property defect, many scholars adopt the method for the two combination when the design artificial disc after arthroplasty, have designed the Novel artificial intervertebral disk prostheses such as Prodisc-L, Prodisc-C, Charite.The Marnay(of France is referring to list of references 6 Marnay T.Prosthesis for intervertebral discs and instruments for implanting it.US Patent, 1994; 5:314-324.) designed a kind of prosthese of cap cup structure, called after ProDisc artificial lumbar disc.Prosthese advanced repeatedly to improve, can be applied to cervical vertebra and lumbar vertebra at present, Prodisc-L is for lumbar vertebra, Prodisc-C is for cervical vertebra, the two forms by upper and lower metal end plate and middle polyethylene core, on function, is 2-member prosthese, for different parts, designs different height and sections curvature, bend and stretch with lateral bending is movable and control within the specific limits, axial-rotation is uncontrolled.In the Prodisc-L artificial intervertebral disk displacement randomized clinical control study of U.S. FDA approval, 286 tested patients follow up a case by regular visits to 2 years, the effective percentage of Prodisc-L prosthetic replacement group reaches 91.8%, and function of nervous system's state of patient and satisfaction rate are all higher than the spinal fusion group, in the time of 24 months, 93.7% artificial disc displacement patient has retained the range of activity of average 7.7 ° (referring to list of references 7 Zigler J, Delamarter R, Spivak JM, et al.Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease.Spine, 2007, 32 (11): 1155-1163).Prodisc-C also ratifies to have carried out randomized clinical control study by U.S. FDA, 209 patients participate in test, 106 are carried out the cervical discectomy interbody fusion, 103 are carried out the artificial disc replacement, the Follow-up results of 2 years shows that the effect of artificial disc after arthroplasty displacement is at least suitable with fusion, even better.(referring to list of references 8 Murrey D; Janssen M; Delamarter R; et al.Results of the prospective; randomized; controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease.Spine J, 2009; 9 (4): 275-86.)
Kurt Schell-nack and Buttner-Janz have designed SB Charite artificial lumbar disc in nineteen eighty-two at the Charite of Berlin institute, within 1984, have carried out clinical practice first.This artificial disc after arthroplasty is further improved subsequently, becomes current form.It is comprised of the polyethylene slip core of cochrome cover plates two symmetries, ovate and a super high molecular weight, relies on the pointed tooth on cover plate to be fixed on vertebral body.Slip core is the biconvex shape, is placed between upper and lower cover plates, and outside is wound with a becket and locates in order to x-ray.Lack surface treatment, the bone not good shortcoming of growing into for metal cover board, also in lid surface, sprayed pure titanium-hydroxyapatite layer.External extensive use at present, clinical research comparatively deep a kind of prosthese (referring to list of references 9 Geisler FH, Blumenthal SL, Guyer RD, et al.Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature:results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc.J Neurosurg Spine, 2004, 1:143-154.).Caspi etc. (referring to list of references 10 Caspi I, Levinkopf M, Nerubay J.Results of lumbar disk prosthesis after a follow-up period of 48 months.Isr Med Assoc J, 2003; 5:9-11.) having reported that 20 examples adopt the regression of SB Charite artificial lumbar disc treatment lumbar intervertebral disc to become 2 years Follow-up results of patient, 80% patient obtains satisfactory effect.Guyer etc. are (referring to list of references 11 Guyer RD; McAfee PC; Hochschuler SH, et al.Prospective randomized study of the Charite artificial disc:Data from two investigational centers.Spine J, 2004; 4:252S-259S.) 144 routine lumbar retrogression patients are studied, wherein 100 examples adopt the treatment of Charite artificial intervertebral disc, and 44 examples adopt the BAKQian road to merge treatment, follow up a case by regular visits to 2 years, with the Oswestry standards of grading, judge therapeutic effect.Result shows that two groups of therapeutic effect do not have significant difference.
The artificial disc after arthroplasty displacement has good potential applicability in clinical practice, but because physiological structure and the biomechanical property of intervertebral disc are very complicated, and lack suitable animal model and carry out zooscopy, therefore the research and development of artificial lumbar disc are comparatively difficult, and its clinical practice is also still in the starting stage.Along with the continuous summary with clinical practice of updating of artificial lumbar disc design, on strict basis of holding indication, artificial intervertebral disc will be brought into play due effect on clinical treatment.
This situation in view of current this technical field, people urgently wish to obtain a kind of rational in infrastructure, Novel artificial intervertebral disk prosthese that material property is outstanding, so that better be applicable to dissection and the biomechanical property requirement of the intervertebral of cervical vertebra and lumbar vertebra, in order to substitute cervical vertebra and intervertebral disc of lumbar vertebra, the disc disease for the treatment of cervical vertebra and lumbar vertebra fully.
Summary of the invention
The purpose of this invention is to provide and a kind ofly can substitute the artificial disc after arthroplasty of cervical vertebra and intervertebral disc of lumbar vertebra fully, be used for the treatment of conservative invalid cervical vertebra and lumbar intervertebral disc disease and carry out the artificial disc after arthroplasty replacement.By the adaptability design at cervical vertebra and lumbar vertebra different segment structure and exercise performance to this prosthese, can reasonably recover form (physiological camber), range of activity and the bearing function of place sections, thereby reach desirable artificial disc after arthroplasty replacement result.Artificial disc replacement based on artificial neck lumbar intervertebral disc of the present invention not only can be removed and cause pain and handicapped intervertebral disc, the physiological movement and the bearing function that have retained the operation sections simultaneously, the stability and the activeness that keep spinal column, avoided closing on the intervertebral disc of sections stress due to excessively increasing and accelerated regression.
A kind of artificial disc after arthroplasty of the present invention, for substituting the intervertebral disc of cervical vertebra and lumbar vertebra fully, specifically is divided into two large classes:
The first kind is two formulas (whole artificial disc after arthroplasty mainly is comprised of two structural members), it is respectively arranged with for coordinating the sliding area of contact between the two specifically by top shoe 1 and sliding block 2 these two functional part mix proportions on top shoe 1 and sliding block 2; Top shoe 1 also is provided with on sliding block 2 fixture that is fixedly connected with use with adjacent vertebral body; It is characterized in that: described artificial disc after arthroplasty also meets following requirement:
1. top shoe 1 main part is connected to one and is formed by top shoe sliding part 102 and top shoe soleplate part 103, and wherein: it is top shoe sliding area 101 that top shoe sliding part 102 is provided with for sliding block 2, coordinating the sliding area contacted away from the centre of top shoe soleplate part 103 1 sides; Top shoe sliding area 101 is by be slidably matched face 104 and be arranged on the be slidably matched top shoe of face 104 both sides of top shoe and extend upper recess surface 105 and form of the top shoe that is positioned at centre; For with sliding block 2, coordinating the top shoe sliding part edge surface 106 that forms bend and stretch/lateral bending position limiting structures to be arranged in the periphery of top shoe sliding part 102 away from the top shoe sliding area 101 of top shoe soleplate part 103 1 side sides;
Top shoe soleplate part 103 is provided with the top shoe fixture 107 that is fixedly connected with use for the vertebral body with adjacent on the side away from top shoe sliding part 102 1 sides;
2. sliding block 2 main parts are connected to one and are formed by sliding block sliding part 202 and sliding block soleplate part 203, and wherein: it is sliding block sliding area 201 that sliding block sliding part 202 is provided with for top shoe 1, coordinating the sliding area contacted away from the centre of sliding block soleplate part 203 1 sides; Sliding block sliding area 201 is by be slidably matched face 204 and be arranged on the be slidably matched sliding block of face 204 both sides of sliding block and extend lower convex surface 205 and form of the sliding block that is positioned at centre; For with top shoe 1, coordinating the sliding block sliding part edge surface 206 that forms position limiting structure to be arranged in the periphery of sliding block sliding part 202 away from the sliding block sliding area 201 of sliding block soleplate part 203 1 side sides;
Sliding block soleplate part 203 is provided with the sliding block fixture 207 that is fixedly connected with use for the vertebral body with adjacent on the side away from sliding block sliding part 202 1 sides;
3. top shoe face 104 and sliding block the two the face that is in contact with one another of face 204 that is slidably matched that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, and another is interior contoured surface;
4. top shoe 1 and sliding block 2 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤18 °;
5. away from top shoe 1 and the top shoe soleplate part 103 of sliding block 2 contact surface one sides and the lateral surface centre of sliding block soleplate part 203, be respectively arranged with adjacent vertebral body and coordinate the outer convex surface 108 of the top shoe contacted, the outer convex surface 208 of sliding block.
Described artificial disc after arthroplasty also includes following content request:
The concrete structure that limits the two relative rotation angle scope on top shoe 1 and sliding block 2 on the horizontal direction at main matching surface center perpendicular to it meets following requirement:
Respectively be provided with respectively 1 top shoe and extend upper recess surface 105 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) of face 104 of top shoe; Accordingly, sliding block be slidably matched the both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) of face 204 respectively be provided with respectively 1 sliding block extend under convex surface 205; That is: sliding block extends lower convex surface 205 and stretches out and be embedded in two groove shape structures that top shoe extends upper recess surface 105 to the described artificial disc after arthroplasty sagittal plane left and right sides and can extend the level of carrying out in certain limit in upper recess surface 105 at top shoe and relatively rotate.
Described artificial disc after arthroplasty meets one of following requirement or its certain combination:
Top shoe 1 and sliding block 2 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it is≤12 °; That is between the top shoe 1 and sliding block 2 of described artificial disc prosthese, relative rotation angle scope around its axis is≤12 °, wherein: for the rotary moveable scope of the artificial disc after arthroplasty of cervical vertebra≤12 °, for the rotary moveable scope of the artificial disc after arthroplasty of lumbar vertebra≤6 °;
The top shoe sliding part edge surface 106 of described artificial disc after arthroplasty on sagittal plane and the angle α of sliding block sliding part edge surface 206≤30 °, that is to realize on sagittal plane bending and stretching movable maximum angle range of activity be 30 °; Wherein: for the bending and stretching range of activity and can reach 30 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 24 ° for the artificial disc after arthroplasty of lumbar vertebra;
The top shoe sliding part edge surface 106 of described artificial disc after arthroplasty on coronalplane and the angle of release α of sliding block sliding part edge surface 206≤20 °, that is the angular range of realizing lateral bending range of activity maximum on coronalplane is 20 °, wherein: for the bending and stretching range of activity and can reach 20 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 12 ° for the artificial disc after arthroplasty of lumbar vertebra.
Top shoe sliding part 102 and top shoe soleplate part 103 meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
Sliding block sliding part 202 and sliding block soleplate part 203 meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
The material of top shoe sliding part 102, sliding block sliding part 202 is polyether-ether-ketone resin (PEEK) or high purity carbon fiberreinforced polyether-ether-ketone resin material (CFR-PEEK); Titanium alloy Ti-Nb-Zr-Sn that the material of top shoe soleplate part 103, sliding block soleplate part 203 is low elastic modulus.
Top shoe face 104 and the sliding block face 204 side shifting 2-8mm that supports or opposes from the prosthese center on sagittal plane that is slidably matched that is slidably matched;
Also be provided with not X-ray or the labelling of X-ray thoroughly thoroughly in described artificial disc after arthroplasty; Labelling is so that reach postoperative inspection and adjustment in operation process;
For and the contact surface of the top shoe soleplate part 103 that is in contact with one another of adjacent vertebral bodies or sliding block soleplate part 203 use plasma spraying method or other method to carry out the preparation of hydroxyapatite material (HA) coating;
Described top shoe fixture 107, sliding block fixture 207 are specially following several one or a combination set of: the screw duct of the outside bur structure of wedge angle, prominent sour jujube, diagonal; The concrete structure of described " prominent sour jujube " meets following requirement: offer groove on adjacent vertebral body sclerotin, coordinate the fin of installation in the correspondence position setting of the artificial disc after arthroplasty with the corresponding contact of this groove with groove;
Following position requires to carry out the circular arc processing of rounding: be slidably matched face 104 and top shoe of top shoe extends upper recess surface 105 junctions, the top shoe that directly connects or connect by transition face extends the corner of the syndeton between upper recess surface 105 and top shoe sliding part edge surface 106, the connection corner between each joint face of outward flange of top shoe sliding part edge surface 106 and/or top shoe soleplate part 103; Be slidably matched face 204 and sliding block of sliding block extends lower convex surface 205 junctions, the corner of the syndeton under the sliding block that directly connects or connects by transition face extends between convex surface 205 and sliding block sliding part edge surface 206; Connection corner between each joint face of outward flange of sliding block sliding part edge surface 206 and/or sliding block soleplate part 203.
The monnolithic case of described artificial disc after arthroplasty is following one of several: circular, oval, semicircle, trapezoidal; The sagittal diameter of described artificial disc after arthroplasty is 8-50mm, and transverse diameter is 10-60mm, is highly 5-30mm, and the ratio of transverse diameter and sagittal diameter is following one of several: 4: 3,5: 3,2: 1; The anterior and posterior height of top shoe soleplate part 103 and sliding block soleplate part 203 is inconsistent, can rebuild the physiological camber of cervical vertebra and lumbar vertebra.
Equations of The Second Kind is three-member type (whole artificial disc after arthroplasty mainly is comprised of three structural members), it is specifically by top shoe 1, sliding block 2, intermediate slider 3 these three functional part mix proportions, and intermediate slider 3 is arranged between the above two and it is in contact with one another to coordinate with the former two respectively and forms sliding area; Top shoe 1 also is provided with on sliding block 2 fixture that is fixedly connected with use with adjacent vertebral body; It is characterized in that: described artificial disc after arthroplasty also meets following requirement:
1. top shoe 1 main part is connected to one and is formed by top shoe sliding part 102 and top shoe soleplate part 103, and wherein: it is top shoe sliding area 101 that top shoe sliding part 102 is provided with for intermediate slider 3, coordinating the sliding area contacted away from the centre of top shoe soleplate part 103 1 sides; Top shoe sliding area 101 is by be slidably matched face 104 and be arranged on the be slidably matched top shoe of face 104 both sides of top shoe and extend upper recess surface 105 and form of the top shoe that is positioned at centre; For with sliding block 2, coordinating the top shoe sliding part edge surface 106 that forms bend and stretch/lateral bending position limiting structures to be arranged in the periphery of top shoe sliding part 102 away from the top shoe sliding area 101 of top shoe soleplate part 103 1 side sides;
Top shoe soleplate part 103 is provided with the top shoe fixture 107 that is fixedly connected with use for the vertebral body with adjacent on the side away from top shoe sliding part 102 1 sides;
2. sliding block 2 main parts are connected to one and are formed by sliding block sliding part 202 and sliding block soleplate part 203, and wherein: it is sliding block sliding area 201 that sliding block sliding part 202 is provided with for intermediate slider 3, coordinating the sliding area contacted away from the centre of sliding block soleplate part 203 1 sides; Sliding block sliding area 201 is by be slidably matched face 204 and be arranged on the be slidably matched sliding block of face 204 both sides of sliding block and extend concave surface 205 and form of the sliding block that is positioned at centre; For with top shoe 1, coordinating the sliding block sliding part edge surface 206 that forms position limiting structure to be arranged in the periphery of sliding block sliding part 202 away from the sliding block sliding area 201 of sliding block soleplate part 203 1 side sides;
Sliding block soleplate part 203 is provided with the sliding block fixture 207 that is fixedly connected with use for the vertebral body with adjacent on the side away from sliding block sliding part 202 1 sides;
3. the upper and lower surface of intermediate slider 3 is provided with respectively and top shoe face 104, the sliding block contacted face that is slidably matched of face 204 that is slidably matched that is slidably matched: intermediate slider upper mating surface 303, the intermediate slider lower mating surface 304 that slides that slides; On intermediate slider slides mating surface 303 and intermediate slider slide under the both sides of mating surface 304 be respectively arranged with respectively with top shoe extend upper recess surface 105, sliding block extend the corresponding intermediate slider of concave surface 205 extend on convex surface 305, intermediate slider extend under convex surface 306; On intermediate slider, the periphery in sliding area 301 and intermediate slider slip underneath zone 302 also is respectively arranged with respectively and top shoe sliding part edge surface 106, the intermediate slider top edge face 307 of sliding block sliding part edge surface 206 corresponding layouts, intermediate slider lower limb face 308;
4. top shoe face 104 and intermediate slider the two the face that is in contact with one another of upper mating surface 303 that slides that is slidably matched be all the part of the sphere that radius of curvature is identical, and one is outer surface, the interior contoured surface of another one; Sliding block face 204 and intermediate slider the two the face that is in contact with one another of lower mating surface 304 that slides that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, and another is interior contoured surface;
5. top shoe 1 and intermediate slider 3 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤9 °, sliding block 2 and intermediate slider 3 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it is≤9 °, top shoe 1 and sliding block 2 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤18 °;
6. away from top shoe 1 and the top shoe soleplate part 103 of sliding block 2 contact surface one sides and the lateral surface centre of sliding block soleplate part 203, be respectively arranged with adjacent vertebral body and coordinate the outer convex surface 108 of the top shoe contacted, the outer convex surface 208 of sliding block.
Described artificial disc after arthroplasty meets one of following requirement or its certain combination:
The concrete structure that limits the two relative rotation angle scope on top shoe 1 and sliding block 2 on the horizontal direction at main matching surface center perpendicular to it meets following requirement:
Respectively be provided with respectively 1 top shoe and extend upper recess surface 105 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) of face 104 of top shoe; Respectively be provided with respectively 1 sliding block and extend concave surface 205 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) of face 204 of sliding block;
Accordingly, on intermediate slider slides mating surface 303 and intermediate slider slide under the both sides of mating surface 304 be respectively arranged with respectively with top shoe extend upper recess surface 105, sliding block extend the corresponding intermediate slider of concave surface 205 extend on convex surface 305, intermediate slider extend under convex surface 306;
Intermediate slider extends upper convex surface 305, intermediate slider and extends lower convex surface 306 and stretch out to the described artificial disc after arthroplasty sagittal plane left and right sides respectively and be embedded into respectively top shoe and extend upper recess surface 105, sliding block and extend in the groove shape structure of concave surface 205 and the level that can carry out in certain limit is therein rotated relatively.
In described artificial disc prosthese, top shoe 1 and sliding block 2 form fit structures by means of intermediate slider 3, wherein: top shoe 1 with respect to sliding block 2 on the horizontal direction at main matching surface center perpendicular to it between the two the relative rotation angle area requirement be≤12 °; Wherein: for the rotary moveable scope of the artificial disc after arthroplasty of cervical vertebra≤12 °, for the rotary moveable scope of the artificial disc after arthroplasty of lumbar vertebra≤6 °;
The top shoe sliding part edge surface 106 of described artificial disc after arthroplasty on sagittal plane, sliding block sliding part edge surface 206 the two respectively and the angle α between intermediate slider top edge face 307, intermediate slider lower limb face 308≤15 °, realizing on sagittal plane bending and stretching movable full range of movement is 30 °, wherein for the bending and stretching range of activity and can reach 30 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 24 ° for the artificial disc after arthroplasty of lumbar vertebra;
Angle of release α≤10 ° between top shoe sliding part edge surface 106, sliding block sliding part edge surface 206 and the intermediate slider top edge face 307 of described artificial disc after arthroplasty on coronalplane, lower limb face 308, realize the range of activity of (lateral bending) on coronalplane maximum 20 °, wherein for the bending and stretching range of activity and can reach 20 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 12 ° for the artificial disc after arthroplasty of lumbar vertebra.
Top shoe sliding part 102 and top shoe soleplate part 103 meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
Sliding block sliding part 202 and sliding block soleplate part 203 meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
The outer edge away from the artificial disc after arthroplasty center of intermediate slider 3 is provided with and prevents slippage structure 309, for to edge barrier structure one-sided or that bilateral is vertically widened;
The material of top shoe sliding part 102, sliding block sliding part 202, intermediate slider 3 is polyether-ether-ketone resin (PEEK) or high purity carbon fiberreinforced polyether-ether-ketone resin material (CFR-PEEK); Titanium alloy Ti-Nb-Zr-the Sn of top shoe soleplate part 103, sliding block soleplate part 203 low elastic modulus.
10, according to one of them described artificial disc after arthroplasty of claim 7-9, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
Top shoe face 104, sliding block face 204, intermediate slider upper mating surface 303 and the intermediate slider lower mating surface 304 side shifting 2-8mm that supports or opposes from the prosthese center on sagittal plane that slides that slides that is slidably matched that is slidably matched;
Angle of release α between top shoe sliding part edge surface 106 and intermediate slider top edge face 307≤15 °, the angle of release α between sliding block sliding part edge surface 206 and intermediate slider lower limb face 308≤15 °; Top shoe edge surface 106, sliding block edge surface 206 are corresponding with angle of release α with the distance between the intermediate slider edge surface, and the flexion angles the displacement jointly the party made progress is controlled within the required range.Above-mentioned angle of release α and distance are different on the different directions of described artificial disc after arthroplasty; Distance is difficult for quantitative description herein, and it is relevant with the diameter on certain direction of whole artificial disc, with to reach to bend and stretch angle also relevant;
Also be provided with not X-ray or the labelling of X-ray thoroughly thoroughly in described artificial disc after arthroplasty; Labelling is so that reach postoperative inspection and adjustment in operation process;
For and the contact surface of the top shoe soleplate part 103 that is in contact with one another of adjacent vertebral bodies or sliding block soleplate part 203 carry out hydroxyapatite material (HA) coating by plasma spraying method or other method and process;
Described top shoe and contiguous terminal plate of vertebral body stationary device 107 and/or sliding block and contiguous terminal plate of vertebral body stationary device 207 are specially following several one or a combination set of: the screw duct of the outside bur structure of wedge angle, prominent sour jujube, diagonal; The concrete structure of described " prominent sour jujube " meets following requirement: offer groove on adjacent vertebral body sclerotin, coordinate the fin of installation in the correspondence position setting of the artificial disc after arthroplasty with the corresponding contact of this groove with groove;
Following position requires to carry out the circular arc processing of rounding: be slidably matched face 104 and top shoe of top shoe extends upper recess surface 105 junctions, the top shoe that directly connects or connect by transition face extends the corner of the syndeton between upper recess surface 105 and top shoe sliding part edge surface 106, the connection corner between each joint face of outward flange of top shoe sliding part edge surface 106 and/or top shoe soleplate part 103; Be slidably matched face 204 and sliding block of sliding block extends concave surface 205 junctions, the sliding block extension concave surface 205 that directly connects or connects by transition face and the corner of the syndeton between sliding block sliding part edge surface 206; Connection corner between each joint face of outward flange of sliding block sliding part edge surface 206 and/or sliding block soleplate part 203; Intermediate slider be slidably matched top 303 and intermediate slider extend upper convex surface 305 junctions, the intermediate slider that directly connects or connects by transition face extends the above corner of syndeton between convex surface 305 and intermediate slider top edge face 307; Intermediate slider be slidably matched following 304 and intermediate slider extend lower convex surface 306 junctions, the corner of syndeton between convex surface 306 and intermediate slider lower limb face 308 under the intermediate slider that directly connects or connects by transition face extends;
The monnolithic case of described artificial disc after arthroplasty is following one of several: circular, oval, semicircle, trapezoidal; The sagittal diameter of described artificial disc after arthroplasty is 8-50mm, and transverse diameter is 10-60mm, is highly 5-30mm, and the ratio of transverse diameter and sagittal diameter is following one of several: 4:, 5: 3,2: 1; The anterior and posterior height of top shoe soleplate part 103 and sliding block soleplate part 203 is inconsistent, can rebuild the physiological camber of cervical vertebra and lumbar vertebra.
Applied in the human anatomy term for the description human body three-dimensional direction of human vertebra in the present invention, existing it is enumerated and is described as follows:
" sagittal plane " or " sagittal plain " refers on fore-and-aft direction object is divided into the longitudinal section of two ones of left and right, " coronalplane " or " Coronal " refers on left and right directions object is divided into the longitudinal section of two ones of front and back, " horizontal plane " refers to vertical with coronalplane with sagittal plane, object is divided into to the plane of upper and lower two ones." sagittal diameter " refers to the front and back end horizontal range of object on sagittal plane, and " transverse diameter " refers to the left and right end horizontal range of object on coronalplane, and " highly " refers to the upper and lower side vertical dimension of object on sagittal plane.
" cooperatively interacting " of the mating surface of mentioning in the present invention refers to that the radius of curvature of male and female face is consistent, contact fully, the convex surface of soleplate part and terminal plate of vertebral body " adapt " convex surface that refers to the soleplate part along the shape of the depression of terminal plate of vertebral body, to reach the large contact surface of trying one's best.
According to the design principle of artificial disc after arthroplasty, prosthese should reach the requirement of three aspects, comprises the lasting stability of rational motion, performance and firmly fixing.The present invention is designed from these three aspects, and makes adaptive scheme for the characteristics of spinal column different parts, better to realize the functional design expection of artificial disc after arthroplasty displacement.
In the two large class artificial disc after arthroplasties that the present invention relates to, the first artificial disc after arthroplasty that intermediate slider 3 is not set is applicable to the artificial disc after arthroplasty displacement of cervical vertebra and lumbar vertebra, through to the adaptability design of this kind of prosthese, being applicable to the small space of cervical vertebral space.Because the center of rotation of this kind of prosthese is fixed, make it be accompanied by forward and backward and movement side when (bending and stretching and lateral bending) when the rotation of front and back and side, the characteristics that more meet the spinal segments motion, and this kind of prosthese has stability preferably, therefore also the type prosthetic replacement also is applicable to the activity of lumbar vertebra and the requirement of carrying.
And the center of rotation that is provided with the second artificial disc after arthroplasty of intermediate slider 3 is not fixed, this prosthese is main after implanting produces rotation (comprise bend and stretch, lateral bending and axial-rotation) motion, and that move side is not obvious, the prosthese that can be applicable to cervical vertebra and lumbar vertebra through adaptability design is implanted.
Two kinds of artificial disc after arthroplasties that the present invention comprises all have sliding area, the first artificial disc after arthroplasty that intermediate slider 3 is not set has the i.e. one group of corresponding contact surface that is slidably matched of one group of sliding area, and the second artificial disc after arthroplasty that is provided with intermediate slider 3 has the i.e. two groups of corresponding contact surfaces that are slidably matched of two sliding areas.
The design of sliding area is the key that realizes the artificial disc after arthroplasty suitable exercise.The centre of sliding area is a spheroid curved surface sliding area, identical (the technique effect optimum of this kind of structure of the radius of curvature of male and female face, it is very high that but the accuracy of manufacture requires, coordinate installation accuracy high, the requirement of working service is higher use also) or concave surface slightly large (with respect to radius of curvature for identical the previous case, the corresponding requirement that suitably reduces its manufacture, installation, working service of the slightly large energy of concave surface), the mutual close contact of curved surface, upper slip in any direction, and remain maximum contact area.The middle spheroid curvature portion of sliding area is to realize each basis to motion of prosthese, and larger contact surface is conducive to reduce wear and strengthens its bearing capacity.The both sides of sliding area extend to the composite surface zone, convex surface is cylinder and spheroid composite surface, concave surface is Rotary-table and cambered surface composite surface, the radius of curvature of concave surface is greater than convex surface, certain distance is arranged between concave and convex surface, the part of extending curved surface when prosthese rotates motion contacts and stops the motion that the party makes progress, and plays the effect of controlling rotation.This middle sphere is free to slide and controls the design of rotating in conjunction with the side curved surface is unique advantage of the present invention, and this will be conducive to prosthese of the present invention and realize accurately controlled lasting stability motor function.The radius of curvature of the middle spheroid curved surface of sliding area and height need to reach movement effects by the spinal segments design and disc height determines, and the radius of curvature difference of the composite surface that extend the sliding area both sides has determined the anglec of rotation that the spinal segments design can reach.
The edge of sliding area extends to the edge opposite face to surrounding, has certain outer angle of release and distance between opposite face, and outer angle of release and distance different on all directions, range of activity that this upwards need to be reached by the party determines.The bend and stretch activity of cervical vertebra on sagittal plane is usually in 30 ° of scopes, and this just needs the outer angle of release of the front and back edge surface of artificial disc after arthroplasty can reach 30 °, the displacement that the distance of edge surface is sagittal plane radius of turn process while reaching outer angle of release angle.The bend and stretch activity of lumbar vertebra on sagittal plane is usually in 24 ° of scopes, and this just needs the outer angle of release of the front and back edge surface of artificial disc after arthroplasty can reach 24 °, the displacement that the distance of edge surface is sagittal plane radius of turn process while reaching outer angle of release angle.The lateral bending activity of cervical vertebra on coronalplane is usually in 20 ° of scopes, and this just needs the outer angle of release of the both sides of the edge face of artificial disc after arthroplasty can reach 20 °, the displacement that the distance of edge surface is coronalplane radius of turn process while reaching outer angle of release angle.The lateral bending activity of lumbar vertebra on coronalplane is usually in 12 ° of scopes, and this just needs the outer angle of release of the both sides of the edge face of artificial disc after arthroplasty can reach 12 °, and the distance of edge surface is for reaching the displacement of the needed coronalplane radius of turn of outer angle of release angle process.The outer angle of release of edge surface on the vertical face of other between median sagittal plane and coronalplane and distance are seamlessly transitted by outer angle of release and the distance on the above two planes.The rotary moveable scope of cervical vertebra on horizontal plane is usually in 12 ° of scopes, and the required distance of the male and female face that extend the sliding area both sides meets the angle that horizontally rotates that reaches 12 ° of scopes.The rotary moveable scope of lumbar vertebra on horizontal plane is usually in 3 ° of scopes, and the required distance of the male and female face that extend the sliding area both sides meets the angle that horizontally rotates that reaches 3 ° of scopes.
Above-described sliding area with and construction features on every side, be that artificial disc after arthroplasty of the present invention is realized the reasonably architecture basics of motion, artificial disc after arthroplasty that will be more current than this area is realized more accurately controlled lasting movement effects.
In order to make artificial disc after arthroplasty can access the performance of lasting stability, artificial disc after arthroplasty of the present invention has carried out conscientiously carefully selecting aspect selection.For the slide unit that forms sliding area, comprise the sliding part of 2-part formula prosthese and sliding part and the intermediate slider of 3-part formula prosthese, that the present invention selects is new special thermoplastic engineering plastic-polyether-ether-ketone resin (Polyetheretherketone, PEEK) or carbon fiber reinforced polyether-ether-ketone resin (Carbon Fiber Reinforced Polyetheretherketone, CFR-PEEK), such material has lot of advantages: 1) low elastic modulus high strength; 2) extremely low wearing and tearing, wherein the latter's wear rate is than low 12 times of the normally used material of current artificial intervertebral disk (polyethylene-cobalt chromium); 3) good biocompatibility, stable performance, the impact of not oxidated and ray; 4) X ray thoroughly, be easy to labelling.These material advantages have determined that polyether-ether-ketone resin is the ideal material of making slide unit, and it can realize sliding capability steady in a long-term, and provides convenience to imaging evaluation.The whole CFR-PEEK material that uses of corresponding part, can when outstanding wearability is provided, reduce the volume of prosthese, and the installation also reduced is loaded down with trivial details.
The sliding part material of prosthese is PEEK or CFR-PEEK, and the material of soleplate part is selected new titanium alloy material Ti-Nb-Zr-Sn.The material that this new titanium alloy material is the autonomous invention of Metal Inst., Chinese Academy of Sciences, have a lot of excellent in performance: 1) low elastic modulus, high strength; 2) elastic deformation ability is strong; 3) good biocompatibility, safety non-toxic; 4) do not affect imaging evaluation.This titanium alloy low elastic modulus characteristic can make soleplate part and terminal plate of vertebral body more mate, and avoids the heavily stressed of contact surface; High strength (its intensity is higher than common medical titanium alloy) is conducive to increase the bearing capacity of prosthese.These material characteristicses have determined that new titanium alloy is the ideal material of making many body slide block soleplate parts.
The slider part of the artificial disc after arthroplasty of the present invention design can be mutually permanently connected but non-dismountable or dismountable part forms by two or more, for demountable structure, between corresponding sliding part and soleplate part, utilize draw-in groove or screw method to be fixed as one.
It is exactly firm fixing that the realization of the lasting stability function of artificial disc after arthroplasty also has an important factor, fixing and permanent fixing comprising immediate postoperative.The present invention is in order to realize the at once fixing of prosthesis endplate part and terminal plate of vertebral body, designs bur, prominent sour jujube or diagonal screw duct as fixture at once on the soleplate part, can select fixing means according to practical situation.At once fixing is not final goal, is in order to realize fixedly providing for a long time time and mechanical environment.The permanent basis that fixedly is only the normal functionating of real assurance artificial disc after arthroplasty.
Prosthese of the present invention is better realized the permanent fixing of prosthese by the design of two aspects: 1) the soleplate part of prosthese is designed with a convex surface on the contact surface with terminal plate of vertebral body, the curvature of convex surface and the depression of terminal plate of vertebral body adapt, purpose is to realize the contact area of soleplate part and terminal plate of vertebral body maximum, so can reduce the stress of contact surface, prevent that the prosthese depression from entering in the vertebral body sclerotin; 2) contact surface of prosthesis endplate part and terminal plate of vertebral body carried out to the hydroxyapatite coating layer processing, this coating material can be embedded by the vertebral body bone tissue growth, and prosthesis endplate part and the vertebral body sclerotin are grown to one, finally realizes stable permanent fixing.The present invention realizes effectively at once fixing and permanent fixing by decision design described above, in the current artificial disc after arthroplasty in this area, have advantage, this for the depression that reduces prosthese and loosening highly significant.
The present invention has also carried out preferably for several details of design.In prosthese of the present invention, the circular arc processing all will be carried out in the edge of all structures or corner, prevents unnecessary parts cutting damage.Because the sliding part of prosthese of the present invention is X-ray material thoroughly, therefore for the ease of imaging evaluation, the annulet of X-ray thoroughly is installed in sliding part not.Artificial disc after arthroplasty of the present invention is installed in operation will be by means of supporting installing apparatus, and therefore, at the soleplate part both sides of prosthese design hole clipping or draw-in groove, this hole clipping or draw-in groove can be connected with installing apparatus, the correct placement of guiding prosthese.This design is also necessary when the artificial disc after arthroplasty Minimally Invasive Surgery.
Because the rotating shaft of human spine's sections flexion and extension is not the center of intervertebral disc, but move a certain distance backward, therefore the sliding area of the prosthese of the present invention's design has moved backward 2-8mm on sagittal plane, so can be more close to the flexion and extension characteristics of physiological status.Moving distance after concrete is adjusted because of the difference of spinal segments.
In the present invention, for the artificial disc after arthroplasty that is provided with intermediate slider 3, have a special technical problem to need to solve: there is the risk that skids off the sliding area that coordinates contact in intermediate slider 3.Once postoperative generation slide block comes off, will produce very large harm to patient's function of nervous system.For this risk, the present invention in the edge designs of intermediate slider an extended structure, the edge of intermediate slider 3 is to barrier structure 309 one-sided or that bilateral is vertically widened.When described artificial disc after arthroplasty, when certain direction moves to the limit, the edge of top shoe 1, sliding block 2 will press to the edge of intermediate slider, be stuck in barrier structure 309 places, thereby prevent that intermediate slider 3 from skidding off to offside.
Because there is physiological bending in the spinal column of human body, cervical vertebra and lumbar vertebra are all physiological lordosis, and intervertebral disc leading edge height is greater than the trailing edge height, therefore, the front and rear edge height of the soleplate part of the artificial disc after arthroplasty of the present invention design is inconsistent, and leading edge is greater than trailing edge, and on sagittal plane, the soleplate part is in echelon.Concrete difference in height is determined by the curvature of spinal segments position and spinal column.
The monnolithic case of the artificial disc after arthroplasty of the present invention's design is determined according to the form of patient's pathological changes vertebral body, can be for circular, oval, semicircle or trapezoidal, its sagittal diameter is 8-50mm, transverse diameter is 10-60mm, be highly 5-30mm, transverse diameter is 4: 3 or 5: 3 or 2: 1 with the ratio of sagittal diameter.
Comprehensive, artificial disc after arthroplasty of the present invention has the selection application of unique sliding area structural design, new material and realizes long-term fixing special construction, and the prosthese that these characteristics make the present invention design has obvious advantage and innovation in the art.By the research of the aspects such as the biocompatibility to the artificial lumbar disc device and biomechanics, be applied to clinical treatment cervical vertebra and Lumbar intervertebral disc Cataplasia disease after reaching corresponding standard.Artificial disc after arthroplasty of the present invention is when removing the pathological interspinal dish, the physiological movement and the loading functionality that have accurately retained the operation sections, the stability and the activeness that keep spinal column, avoided the intervertebral disc of neighbouring section stress due to increasing to accelerate regression, these performance advantages make it that fabulous application prospect be arranged in the art.
The accompanying drawing explanation
Fig. 1 is the coronalplane schematic diagram that is not provided with the first artificial disc after arthroplasty of intermediate slider 3;
Fig. 2 is the central sagittal plane schematic diagram that is not provided with the first artificial disc after arthroplasty of intermediate slider 3;
Fig. 3 is the horizontal plane schematic diagram that is not provided with the first artificial disc after arthroplasty of intermediate slider 3;
Fig. 4 is the coronalplane schematic diagram that is provided with the second artificial disc after arthroplasty of intermediate slider 3;
Fig. 5 is the central sagittal plane schematic diagram that is provided with the second artificial disc after arthroplasty of intermediate slider 3;
Fig. 6 is the horizontal plane schematic diagram that is provided with the second artificial disc after arthroplasty of intermediate slider 3;
Fig. 7 is one of artificial disc after arthroplasty bulk shape schematic diagram;
Fig. 8 is two of artificial disc after arthroplasty bulk shape schematic diagram;
Fig. 9 is three of artificial disc after arthroplasty bulk shape schematic diagram;
Figure 10 is four of artificial disc after arthroplasty bulk shape schematic diagram;
Figure 11 is five of artificial disc after arthroplasty bulk shape schematic diagram;
Figure 12 is one of artificial disc after arthroplasty soleplate part fixed form schematic diagram;
Figure 13 is two of artificial disc after arthroplasty soleplate part fixed form schematic diagram;
Figure 14 is three of artificial disc after arthroplasty soleplate part fixed form schematic diagram;
Figure 15 is four of artificial disc after arthroplasty soleplate part fixed form schematic diagram;
Figure 16 is five of artificial disc after arthroplasty soleplate part fixed form schematic diagram;
Figure 17 is six of artificial disc after arthroplasty soleplate part fixed form schematic diagram;
Figure 18 is seven of artificial disc after arthroplasty soleplate part fixed form schematic diagram;
Figure 19 is eight of artificial disc after arthroplasty soleplate part fixed form schematic diagram.
The specific embodiment
In order more to vividly describe artificial disc after arthroplasty of the present invention, below by legend, be specifically described:
Fig. 1 is the coronalplane schematic diagram that is not provided with the first artificial disc after arthroplasty (2 formula artificial disc after arthroplasties) of intermediate slider 3; Shown in Fig. 1, artificial disc after arthroplasty has top shoe 1 and 2 two functional parts of sliding block, and they form and utilize certain mode to be fixed as one by corresponding sliding part and soleplate part respectively.Between top shoe 1 and sliding block 2, the sliding area be in contact with one another is arranged, comprise the top shoe sliding area 101 of top shoe sliding part 102 and the sliding block sliding area 201 of sliding block sliding part 202.The top shoe that each sliding area mid portion is the spheroid curved surface that radius of curvature is identical face 104 and the sliding block face 204 that is slidably matched that is slidably matched, both sides extend to cylinder (or Rotary-table) and sphere (or arc surface) combination male and female face: top shoe extends upper recess surface 105 and sliding block extends lower convex surface 205, and the radius of curvature of the top shoe matched extension upper recess surface 105 is greater than sliding block and extends lower convex surface 205.The edge of top shoe sliding area 101 and sliding block sliding area 201 comprises top shoe sliding part edge surface 106 and sliding block sliding part edge surface 206, the above and following between certain distance and angle of release α are arranged.Sliding area extends the composite surface part and matches with edge surface partial distance and angle of release α, jointly realizes the controlled motion on the lateral bending direction.Be provided with top shoe fixture 107 and sliding block fixture 207 between top shoe 1 and sliding block 2 and adjacent vertebral bodies, in order to reach stablizing effect at once.Top shoe soleplate part 103 and sliding block soleplate part 203 have the outer convex surface 108 of top shoe and the outer convex surface 208 of sliding block that the middle body with adjacent vertebral bodies vertebral plate contact surface adapts, so can increase soleplate part 103 and 203 and the contact area of terminal plate of vertebral body, be conducive to dispersive stress, prevent the implants depression, improve implants-bone bonding strength, realize the implants long-term stability.
Fig. 2 is the central sagittal plane schematic diagram that is not provided with the first artificial disc after arthroplasty (2 formula artificial disc after arthroplasties) of intermediate slider 3; Shown in Fig. 2, because artificial disc after arthroplasty sliding area of the present invention extends to lateral symmetry, therefore on central sagittal plane, sliding area shows as simple ball-and-socket joint structure, and the sliding block that top shoe on top shoe 1 is slidably matched on face 104 and sliding block 2 face 204 that is slidably matched coordinates and forms joints.Motion on sagittal plane is controlled by the top shoe sliding part edge surface 106 at sliding area the place ahead and rear and distance and the angle of release α between sliding block sliding part edge surface 206, to realize accurate flexion and extension.Because the rotation of bending and stretching of cervical vertebra and lumbar motion segment moves after relative in the heart, top shoe sliding area 101 and the sliding block sliding area 201 of the artificial intervertebral disk prosthesis of the present invention move a certain distance backward on sagittal plane, better to realize the physiological flexion and extension.Because there are physiological lordosis in cervical vertebra and lumbar vertebra, so the top shoe soleplate part 103 of the artificial intervertebral disk prosthesis of the present invention and sliding block soleplate part 203 front height are greater than rear portion, to rebuild the physiological bending of cervical vertebra and lumbar vertebra.
Fig. 3 is the horizontal plane schematic diagram that is not provided with the first artificial disc after arthroplasty (2 formula artificial disc after arthroplasties) of intermediate slider 3; Shown in Fig. 3, artificial disc after arthroplasty shows more intuitively the construction features that it realizes controlled rotation on the horizontal plane of sliding area.Sliding area intermediate face portion is that top shoe face 104 and the sliding block face 204 that is slidably matched that is slidably matched provides enough contact interfaces for rotatablely moving, in conjunction with the excellent in performance of the selected CFR-PEEK material of sliding part, fully ensured that rotatablely move smooth-going carries out.And the extension top shoe of sliding area both sides extends upper recess surface 105 and the lower convex surface 205 of sliding block extension is the keys that realize Spin Control.Because extending upper recess surface 105 Rotary-table curvature portions, top shoe is greater than convex surface 205 cylinder curvature portions under the sliding block extension in sagittal radius of curvature, and top shoe extends between upper recess surface 105 and the lower convex surface 205 of sliding block extension certain distance and angle, while reaching this distance and angle when rotatablely moving, upper recess surface contacts with lower convex surface, thereby realizes the control rotatablely moved.
Fig. 4 is the coronalplane schematic diagram that is provided with the second artificial disc after arthroplasty of intermediate slider 3; Shown in Fig. 3, artificial disc after arthroplasty has top shoe 1, sliding block 2,3 three functional parts of intermediate slider, and top shoe 1 and sliding block 2 form by sliding part and soleplate part, and the latter two utilize certain mode to be fixed as one.Between top shoe 1 and sliding block 2 and intermediate slider 3, the sliding area be in contact with one another is arranged, comprise the depression hole 101 and 201 of top shoe and sliding block, the convex surface 301 and 302 of intermediate slider.The sliding area mid portion is the spheroid curved surface sliding area 104,204,303 and 304 that radius of curvature is identical, both sides extend to cylinder (or Rotary-table) and sphere (or arc surface) combination male and fomale(M&F) 105,205,305 and 306, and corresponding top shoe and sliding block extend concave surface 105 and 205(Rotary-table curvature portion) radius of curvature be greater than intermediate slider and extend upper convex surface 305 and extend lower convex surface 306(cylinder curvature portion).Sliding area 101,201,301 and 302 edge comprise outside, edge 106 and 206, and edge inner face 307 and 308, and certain distance and angle of release α are arranged between inner face and outside.Sliding area extends the composite surface part and matches with edge surface partial distance and angle of release α, jointly realizes the controlled motion on the lateral bending direction.For 3-part formula prosthese, because there is the risk skid off in intermediate slider, the present invention in the edge designs of intermediate slider the barrier structure 309 of vertically widening, this structure can prevent that intermediate slider is to the slippage of reverse movement direction.There are fixture 107 and 207 between top shoe 1 and sliding block 2 and adjacent vertebral bodies, in order to reach stablizing effect at once.Soleplate part 103 and 203 has the convex surface 108 and 208 that the middle body with adjacent vertebral bodies vertebral plate contact surface adapts, so can increase soleplate part 103 and 203 and the contact area of terminal plate of vertebral body, be conducive to dispersive stress, prevent the implants depression, improve implants-bone bonding strength, realize the implants long-term stability.
Fig. 5 is the central sagittal plane schematic diagram that is provided with the second artificial disc after arthroplasty of intermediate slider 3; Shown in Fig. 5, because artificial disc after arthroplasty sliding area of the present invention extends to lateral symmetry, therefore on central sagittal plane, sliding area shows as two ball-and-socket joint structures, i.e. the depression of top shoe 1 and sliding block 2 hole 104 and 204 and convex surface 303 and 304 associated section of intermediate slider.Motion on sagittal plane is controlled by distance and the angle of release α between the edge surface 106,206,307 and 308 at sliding area the place ahead and rear, to realize accurate flexion and extension.Because the rotation of bending and stretching of cervical vertebra and lumbar motion segment moves after relative in the heart, the sliding area 101,201,301 and 302 of the artificial intervertebral disk prosthesis of the present invention moves a certain distance backward on sagittal plane, better to realize the physiological flexion and extension.Because there are physiological lordosis in cervical vertebra and lumbar vertebra, so the soleplate part 103 of the artificial intervertebral disk prosthesis of the present invention and 203 front height are greater than rear portion, to rebuild the physiological bending of cervical vertebra and lumbar vertebra.
Fig. 6 is the horizontal plane schematic diagram that is provided with the second artificial disc after arthroplasty of intermediate slider 3; Shown in Fig. 6, artificial disc after arthroplasty shows more intuitively the construction features that it realizes controlled rotation on the horizontal plane of sliding area.Sliding area intermediate face portion 104,204,303 and 304 provides enough contact interfaces for rotatablely moving, in conjunction with the excellent in performance of sliding part and the selected CFR-PEEK material of intermediate slider, fully ensured that rotatablely move smooth-going carries out.And the extension 105,205,305 and 306 of sliding area both sides is the keys that realize Spin Control.Due to upper recess surface 105 and concave surface 205 Rotary-table curvature portions sagittal radius of curvature be greater than intermediate slider extend on convex surface 305 and extend under convex surface 306 cylinder curvature portions, upper concave surface 105 and 205 and middle extend upper convex surface 305 and extend between lower convex surface 306 certain distance and angle are arranged, while reaching this distance and angle when rotatablely moving, upper recess surface contacts with lower convex surface, thereby realizes the control rotatablely moved.
Fig. 7-Figure 11 is artificial disc after arthroplasty bulk shape schematic diagram; Multiple integral body (soleplate part) the external form schematic diagram of the present invention's design, comprise ellipse (Fig. 7, Fig. 8), semicircle (Fig. 9), trapezoidal (Figure 10), apple shape (Figure 11).Because there are physiological lordosis in cervical vertebra and lumbar vertebra, its spinal column longitudinal stress axle moves with respect to the vertebral body center back, therefore the present invention has carried out adaptability design, comprising moving certain distance after sliding area, and relatively increases soleplate part 103 and 203 rear width.These are conducive to carry better axial load, rationally increase soleplate part 103 and 203 and the contact surface of adjacent vertebral bodies soleplate, prevent the implants depression.Above-mentioned several soleplate part external form has embodied these design concepts preferably.
Figure 12-Figure 19 is artificial disc after arthroplasty soleplate part fixed form schematic diagram; The present invention is in order to realize prosthesis endplate part 103 and 203 and terminal plate of vertebral body at once fixing (for being permanently fixed, by fixing at once of certain structure realization and contiguous vertebral body), design bur (Figure 14, Figure 15), diagonal screw duct (Figure 16, Figure 17) or prominent sour jujube (Figure 18, Figure 19) conduct fixture at once on soleplate part 103 and 203, can select fixing means according to practical situation.
For the more specifically accurate design of the artificial intervertebral disk prosthesis of bright the present invention, now according to structure and the exercise data of cervical vertebra and lumbar vertebra, carry out the specific embodiment description:
1 one kinds of artificial disc after arthroplasties for fully alternative cervical vertebra of embodiment, background relates to neck 4-5 intervertebral disc degeneration and a dysfunction, need carry out the cervical disc replacement surgery of this sections, and patient's adjacent discs 26S Proteasome Structure and Function is normal.Need before prosthetic designs the patient is carried out to a series of imaging examinations, comprising: the c spine ap & lat DR of neutral position, cervical vertebra bend and stretch side position power DR, cervical vertebra lateral bending normotopia power DR, Cervical Rotating normotopia power DR, cervical vertebra three dimensional CT.
By the measurement to imaging data, obtain following data: the anteflexion range of activity (ROM) of neck 3-4 intervertebral disc is α Flx, after to stretch ROM be α Ex, lateral bending ROM is α LatIf (the left and right lateral bending is inconsistent, averages), rotation ROM are α RoIf when (left rotation and right rotation is inconsistent, averages), flexion and extension, center of rotation is apart from the distance L of intervertebral disc sagittal diameter mid point R3-4, leading edge height H during neck 3-4 intervertebral disc neutral position A3-4, and trailing edge height H P3-4The anteflexion range of activity (ROM) of neck 5-6 intervertebral disc is γ Flx, after to stretch ROM be γ Ex, lateral bending ROM is γ LatIf (the left and right lateral bending is inconsistent, averages), rotation ROM are γ RoIf when (left rotation and right rotation is inconsistent, averages), flexion and extension, center of rotation is apart from the distance L of intervertebral disc sagittal diameter mid point R5-6, leading edge height H during neck 5-6 intervertebral disc neutral position A5-6, and trailing edge height H P5-6The sagittal diameter L of pathological interspinal dish neck 4-5 Ap4-5, transverse diameter L Lr4-5, and the three-dimensional configuration (the depression form that comprises shape, sagittal plane and the coronalplane of horizontal plane) of contiguous terminal plate of vertebral body.
According to above measured iconography data, carry out the design of the artificial disc after arthroplasty used for the neck 4-5 intervertebral disc replacement of this patient's pathological changes, comprise overall structure selection, the structural design of sliding area and the structural design of soleplate part.Excessive or not enough for fear of moving, the neck 4-5 intervertebral disc of pathological changes will reach the intermediate value that kinestate is got upper and lower two adjacent discs exercise datas.
In the process of bending and stretching, the motion of vertebral body sections is to rotate to be the master usually for cervical vertebra, and the vertebral body followed moves forward and backward not obvious, and now we select the prosthetic designs of 3-part formula structure.The profile of whole artificial cervical intervertebral disc prosthese is semicircle, ellipse or " D " font similar to the shape of contiguous vertebral body horizontal section, its sagittal diameter L Ap=L Ap4-5-4 (mm), transverse diameter L Lr=L Lr4-5-5 (mm), height H=(H A3-4+ H P3-4+ H A5-6+ H P5-6)/4.
According to the data of measuring, the structure of design sliding area:
1) the upper lower sphere convex curvature radius of intermediate slider is identical, sets the curved surface height H cFor 1/4 of whole height, the base radius r that sets curved surface is 2.5 times of curved surface height, has: H c=H/4, r=H c* 2.5
The radius of curvature R of spheroid curved surface is: R=(r 2+ H c 2)/2H c
The arc angle Α of spheroid convex surface is: Α=2Sin -1(r/R);
2) the spheroid concave surface of sliding area matches with the intermediate slider convex surface, and the radius of curvature of male and female face is identical;
3) position of sliding area on sagittal plane adjusts accordingly according to the center of rotation position of measuring, and the sliding area center back moves a certain distance L c, have: L c(L R3-4+ L R5-6)/2;
The radius of curvature of the concave and convex surface that 4) extend the sliding area both sides, convex surface extends to cylinder, and its end is the sphere concentric with the sliding area center of rotation, extends the convex surface height H ySpheroid curved surface height H in the middle of being set as c2/5, and the coronalplane of setting convex surface be semicircle, the i.e. radius of curvature R of convex surface y=H y=2H c/ 5, the width W that end extends yFor 1/2nd of spheroid both sides of the edge face width degree, have: W y=(L Lr/ 2-r)/2;
Upper recess surface is corresponding irregular Rotary-table curved surface, certain sagittal plane upper recess surface summit to corresponding convex surface summit apart from a and the required lateral bending angle [alpha] reached LatHorizontally rotate the distance L at center apart from prosthese with this sagittal plane hRelevant, have:
a=Sin（α Lat/4）×L h×2
The radius of curvature R of upper recess surface sWith the upper recess surface summit to the convex surface summit apart from translation distance L during rotation before and after a and upper recess surface rRelevant, have: L r=Sin (α Flx/ 4) (R-Hc+H y) * 2, R s=a+r+(Lr-a 2)/2a,
The end of upper recess surface is the arc surface matched on coronalplane with lower convex surface end.
The Spin Control angle that can realize by above design is α r, have:
α r=4Sin -1Lr/{2×[r-Sin（α Lat/4）×R/Cos(A/2-α Lat/4)]}；
5) angle of release α and the distance L of sliding area edge surface, wherein distance L means by the distance of prosthese spheroid male and female face outer rim, with sliding area front edge face (α aAnd L a) be calculated as example, have: α a=(α Flx+ γ Flx)/4,
L a=R×Sin(α a/2)×2
The angle of release at sliding area both sides and rear and distance are in like manner calculated, and the edge surface angle of release of other eccentric occlusion direction and distance be take aforementioned 4 directions and seamlessly transitted as basis.
Because 3-part formula prosthese exists two sliding surfaces and corresponding edge opposite face, therefore to reach the bending amplitude of designing requirement, in the middle of it above slide block or following edge surface only need control separately the motion amplitude of half.
Structure according to measurement data design soleplate part:
1) height H of soleplate part above or below endBe set as 1/6 of whole prosthese height H, i.e. H end=H/6.Because there is physiological lordosis in cervical vertebra, its leading edge height is greater than trailing edge, so soleplate part integral body on median sagittal plane is trapezoidal, the leading edge height H End-aBe greater than the trailing edge height H End-p, have:
H end-a=H end+[(H a3-4+H a5-6)-(H p3-4+H p5-6)]/8
H end-p=H end-[(H a3-4+H a5-6)-(H p3-4+H p5-6)]/8；
2) the protruding form of the contact surface of soleplate part and terminal plate of vertebral body is designed according to cervical vertebra three dimensional CT result, comprises that projection is at the width of sagittal plane and coronalplane and height.
Through above calculating, completed the design of artificial cervical intervertebral disc prosthese, this prosthese can accurately reach the desired range of activity of cervical vertebra sections and mode, and meet intervertebral disc space structure and physiological camber to be implanted, prosthese implant after will with the motion close fit of neighbouring section, realize motion and the bearing function of cervical vertebra sections steady in a long-term by the bone tissue growth of soleplate contact surface.
2 one kinds of artificial disc after arthroplasties for fully alternative lumbar vertebra of embodiment, background relates to a waist 4-5 intervertebral disc degeneration and dysfunction, need to carry out the lumbar disc prosthesis operation of this sections, and patient's adjacent discs 26S Proteasome Structure and Function is normal.Need before prosthetic designs the patient is carried out to a series of imaging examinations, comprising: the l spine ap & lat DR of neutral position, lumbar vertebra bend and stretch side position power DR, lumbar vertebra lateral bending normotopia power DR, lumbar vertebra rotation normotopia power DR, lumbar vertebra three dimensional CT.
By the measurement to imaging data, obtain following data: the anteflexion range of activity (ROM) of waist 3-4 intervertebral disc is α Flx, after to stretch ROM be α Ex, lateral bending ROM is α LatIf (the left and right lateral bending is inconsistent, averages), rotation ROM are α RoIf when (left rotation and right rotation is inconsistent, averages), flexion and extension, center of rotation is apart from the distance L of intervertebral disc sagittal diameter mid point R3-4, leading edge height H during waist 3-4 intervertebral disc neutral position A3-4, and trailing edge height H P3-4The anteflexion range of activity (ROM) of waist 5-sacrum 1 intervertebral disc is γ Flx, after to stretch ROM be γ Ex, lateral bending ROM is γ LatIf (the left and right lateral bending is inconsistent, averages), rotation ROM are γ RoIf when (left rotation and right rotation is inconsistent, averages), flexion and extension, center of rotation is apart from the distance L of intervertebral disc sagittal diameter mid point R5-1, leading edge height H during waist 5-sacrum 1 intervertebral disc neutral position A5-1, and trailing edge height H P5-1The sagittal diameter L of pathological interspinal dish waist 4-5 Ap4-5, transverse diameter L Lr4-5, and the three-dimensional configuration (the depression form that comprises shape, sagittal plane and the coronalplane of horizontal plane) of contiguous terminal plate of vertebral body.
According to above measured iconography data, carry out the design of the artificial disc after arthroplasty used for the waist 4-5 intervertebral disc replacement of this patient's pathological changes, comprise overall structure selection, the structural design of sliding area and the structural design of soleplate part.Excessive or not enough for fear of moving, the waist 4-5 intervertebral disc of pathological changes will reach the intermediate value that kinestate is got upper and lower two adjacent discs exercise datas.
Lumbar vertebra usually in the process of bending and stretching the reach of vertebral body and after move more obviously, i.e. the motion of lumbar motion segment rotation is accompanied by the vertebral body transverse shifting, and lumbar vertebra has important carrying effect, now we select the prosthetic designs of 2-part formula structure.The profile of whole lumbar vertebra artificial disc after arthroplasty is semicircle, ellipse or " D " font similar to the shape of contiguous vertebral body horizontal section, its sagittal diameter L Ap=L Ap4-5-6 (mm), transverse diameter L Lr=L Lr4-5-8 (mm), height H=(H A3-4+ H P3-4+ H A5-6+ H P5-6)/4.
According to the data of measuring, the structure of design sliding area:
1) the upper lower sphere convex curvature radius of intermediate slider is identical, sets the curved surface height H cFor 1/3 of whole height, the base radius r that sets curved surface is 2 times of curved surface height, has: H c=H/3, r=H c* 2
The radius of curvature R of spheroid curved surface is: R=(r 2+ H c 2)/2H c
The arc angle Α of spheroid convex surface is: Α=2Sin -1(r/R);
2) the spheroid concave surface of sliding area matches with convex surface, and the radius of curvature of male and female face is identical;
3) position of sliding area on sagittal plane adjusts accordingly according to the center of rotation position of measuring, and the sliding area center back moves a certain distance L c, have: L c=(Lr 3-4+ L R5-6)/2;
The radius of curvature of the concave and convex surface that 4) extend the sliding area both sides, convex surface extends to cylinder, and its end is the sphere concentric with the sliding area center of rotation, extends the convex surface height H ySpheroid curved surface height H in the middle of being set as c2/5ths, and the coronalplane of setting convex surface be semicircle, the i.e. radius of curvature R of convex surface y=H y=2H c/ 5, the width W that end extends yFor 1/2nd of spheroid both sides of the edge face width degree, have: Wy=(L Lr/ 2-r)/2;
Upper recess surface is corresponding irregular Rotary-table curved surface, certain sagittal plane upper recess surface summit to corresponding convex surface summit apart from a and the required lateral bending angle [alpha] reached LatHorizontally rotate the distance L at center apart from prosthese with this sagittal plane hRelevant, have:
a=Sin（α Lat/2）×L h×2
The radius of curvature R of upper recess surface sWith the upper recess surface summit to the convex surface summit apart from before and after a and upper recess surface during rotation translation distance Lr relevant, have: L r=Sin (α Flx/ 2) (R-Hc+H y) * 2, R s=a+r+(L r-a 2)/2a,
The end of upper recess surface is the arc surface matched on coronalplane with lower convex surface end.
The Spin Control angle that can realize by above design is α r, have:
α r=2Sin -1Lr/{2×[r-Sin（α Lat/2）×R/Cos(A/2-α Lat/2)]}；
5) angle of release α and the distance L of sliding area edge surface, wherein distance L means by the distance of prosthese spheroid concave surface outer rim, with sliding area front edge face (α aAnd L a) be calculated as example, have:
α a=(α Flx+γ Flx)/2，L a=R×Sin(α a/2)×2
The angle of release at sliding area both sides and rear and distance are in like manner calculated, and the edge surface angle of release of other eccentric occlusion direction and distance be take aforementioned 4 directions and seamlessly transitted as basis.
Structure according to measurement data design soleplate part:
1) height H of soleplate part above or below endBe set as 1/6 of whole prosthese height H, i.e. H end=H/6.Because there is physiological lordosis in lumbar vertebra, its leading edge height is greater than trailing edge, so soleplate part integral body on median sagittal plane is trapezoidal, the leading edge height H End-aBe greater than the trailing edge height H End-p,
H end-a=H end+[(H a3-4+H a5-6)-(H p3-4+H p5-6)]/8
H end-p=H end-[(H a3-4+H a5-6)-(H p3-4+H p5-6)]/8；
2) the protruding form of the contact surface of soleplate part and terminal plate of vertebral body is designed according to lumbar vertebra three dimensional CT result, comprises that projection is at the width of sagittal plane and coronalplane and height.
Through above calculating, completed the design of lumbar vertebra artificial disc after arthroplasty, this prosthese can accurately reach the desired range of activity of lumbar motion segment and mode, 2-part formula is convenient to provide better bearing capacity, prosthese meets intervertebral disc space structure and physiological camber to be implanted, prosthese implant after will with the motion close fit of neighbouring section, realize motion and the bearing function of lumbar motion segment steady in a long-term by the bone tissue growth of soleplate contact surface.
3 one kinds of artificial disc after arthroplasties of embodiment, for substituting the intervertebral disc of cervical vertebra and lumbar vertebra fully, be specially two formulas (whole artificial disc after arthroplasty mainly is comprised of two structural members), it is respectively arranged with for coordinating the sliding area of contact between the two specifically by top shoe 1 and sliding block 2 these two functional part mix proportions on top shoe 1 and sliding block 2; Top shoe 1 also is provided with on sliding block 2 fixture that is fixedly connected with use with adjacent vertebral body; It is characterized in that: described artificial disc after arthroplasty also meets following requirement:
1. top shoe 1 main part is connected to one and is formed by top shoe sliding part 102 and top shoe soleplate part 103, and wherein: it is top shoe sliding area 101 that top shoe sliding part 102 is provided with for sliding block 2, coordinating the sliding area contacted away from the centre of top shoe soleplate part 103 1 sides; Top shoe sliding area 101 is by be slidably matched face 104 and be arranged on the be slidably matched top shoe of face 104 both sides of top shoe and extend upper recess surface 105 and form of the top shoe that is positioned at centre; For with sliding block 2, coordinating the top shoe sliding part edge surface 106 that forms bend and stretch/lateral bending position limiting structures to be arranged in the periphery of top shoe sliding part 102 away from the top shoe sliding area 101 of top shoe soleplate part 103 1 side sides;
Top shoe soleplate part 103 is provided with the top shoe fixture 107 that is fixedly connected with use for the vertebral body with adjacent on the side away from top shoe sliding part 102 1 sides;
2. sliding block 2 main parts are connected to one and are formed by sliding block sliding part 202 and sliding block soleplate part 203, and wherein: it is sliding block sliding area 201 that sliding block sliding part 202 is provided with for top shoe 1, coordinating the sliding area contacted away from the centre of sliding block soleplate part 203 1 sides; Sliding block sliding area 201 is by be slidably matched face 204 and be arranged on the be slidably matched sliding block of face 204 both sides of sliding block and extend lower convex surface 205 and form of the sliding block that is positioned at centre; For with top shoe 1, coordinating the sliding block sliding part edge surface 206 that forms position limiting structure to be arranged in the periphery of sliding block sliding part 202 away from the sliding block sliding area 201 of sliding block soleplate part 203 1 side sides;
Sliding block soleplate part 203 is provided with the sliding block fixture 207 that is fixedly connected with use for the vertebral body with adjacent on the side away from sliding block sliding part 202 1 sides;
3. top shoe face 104 and sliding block the two the face that is in contact with one another of face 204 that is slidably matched that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, and another is interior contoured surface;
4. top shoe 1 and sliding block 2 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤18 °;
5. away from top shoe 1 and the top shoe soleplate part 103 of sliding block 2 contact surface one sides and the lateral surface centre of sliding block soleplate part 203, be respectively arranged with adjacent vertebral body and coordinate the outer convex surface 108 of the top shoe contacted, the outer convex surface 208 of sliding block.
Described artificial disc after arthroplasty also includes following content request:
The concrete structure that limits the two relative rotation angle scope on top shoe 1 and sliding block 2 on the horizontal direction at main matching surface center perpendicular to it meets following requirement: in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) of face 104 of top shoe, respectively be provided with respectively 1 top shoe and extend upper recess surface 105; Accordingly, sliding block be slidably matched the both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) of face 204 respectively be provided with respectively 1 sliding block extend under convex surface 205; That is: under the sliding block, convex surface 205 stretches out and is embedded in two groove shape structures that top shoe extends upper recess surface 105 to the described artificial disc after arthroplasty sagittal plane left and right sides and can extend the level of carrying out in certain limit in upper recess surface 105 at top shoe and relatively rotate.
Described artificial disc after arthroplasty meets one of following requirement or its certain combination: top shoe 1 and sliding block 2 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it is≤and 12 °; That is between the top shoe 1 and sliding block 2 of described artificial disc prosthese, relative rotation angle scope around its axis is≤12 °, wherein: for the rotary moveable scope of the artificial disc after arthroplasty of cervical vertebra≤12 °, for the rotary moveable scope of the artificial disc after arthroplasty of lumbar vertebra≤6 °; The top shoe sliding part edge surface 106 of described artificial disc after arthroplasty on sagittal plane and the angle α of sliding block sliding part edge surface 206≤30 °, that is to realize on sagittal plane bending and stretching movable maximum angle range of activity be 30 °; Wherein: for the bending and stretching range of activity and can reach 30 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 24 ° for the artificial disc after arthroplasty of lumbar vertebra; The top shoe sliding part edge surface 106 of described artificial disc after arthroplasty on coronalplane and the angle of release α of sliding block sliding part edge surface 206≤20 °, that is the angular range of realizing lateral bending range of activity maximum on coronalplane is 20 °, wherein: for the bending and stretching range of activity and can reach 20 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 12 ° for the artificial disc after arthroplasty of lumbar vertebra.
Top shoe sliding part 102 and top shoe soleplate part 103 meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
Sliding block sliding part 202 and sliding block soleplate part 203 meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
The material of top shoe sliding part 102, sliding block sliding part 202 is polyether-ether-ketone resin (PEEK) or high purity carbon fiberreinforced polyether-ether-ketone resin material (CFR-PEEK); Titanium alloy Ti-Nb-Zr-Sn that the material of top shoe soleplate part 103, sliding block soleplate part 203 is low elastic modulus.Top shoe face 104 and the sliding block face 204 side shifting 2-8mm that supports or opposes from the prosthese center on sagittal plane that is slidably matched that is slidably matched;
Also be provided with not X-ray or the labelling of X-ray thoroughly thoroughly in described artificial disc after arthroplasty; Labelling is so that reach postoperative inspection and adjustment in operation process; For and the contact surface of the top shoe soleplate part 103 that is in contact with one another of adjacent vertebral bodies or sliding block soleplate part 203 use plasma spraying method or other method to carry out the preparation of hydroxyapatite material (HA) coating; Described top shoe fixture 107, sliding block fixture 207 are specially following several one or a combination set of: the screw duct of the outside bur structure of wedge angle, prominent sour jujube, diagonal; The concrete structure of described " prominent sour jujube " meets following requirement: offer groove on adjacent vertebral body sclerotin, coordinate the fin of installation in the correspondence position setting of the artificial disc after arthroplasty with the corresponding contact of this groove with groove;
Following position requires to carry out the circular arc processing of rounding: be slidably matched face 104 and top shoe of top shoe extends upper recess surface 105 junctions, the top shoe that directly connects or connect by transition face extends the corner of the syndeton between upper recess surface 105 and top shoe sliding part edge surface 106, the connection corner between each joint face of outward flange of top shoe sliding part edge surface 106 and/or top shoe soleplate part 103; Be slidably matched face 204 and sliding block of sliding block extends lower convex surface 205 junctions, the corner of the syndeton under the sliding block that directly connects or connects by transition face extends between convex surface 205 and sliding block sliding part edge surface 206; Connection corner between each joint face of outward flange of sliding block sliding part edge surface 206 and/or sliding block soleplate part 203.
The monnolithic case of described artificial disc after arthroplasty is following one of several: circular, oval, semicircle, trapezoidal; The sagittal diameter of described artificial disc after arthroplasty is 8-50mm, and transverse diameter is 10-60mm, is highly 5-30mm, and the ratio of transverse diameter and sagittal diameter is following one of several: 4: 3,5: 3,2: 1; The anterior and posterior height of top shoe soleplate part 103 and sliding block soleplate part 203 is inconsistent, can rebuild the physiological camber of cervical vertebra and lumbar vertebra.
4 one kinds of artificial disc after arthroplasties of embodiment, for substituting the intervertebral disc of cervical vertebra and lumbar vertebra fully, for three-member type (whole artificial disc after arthroplasty mainly is comprised of three structural members), it is specifically by top shoe 1, sliding block 2, intermediate slider 3 these three functional part mix proportions, and intermediate slider 3 is arranged between the above two and it is in contact with one another to coordinate with the former two respectively and forms sliding area; Top shoe 1 also is provided with on sliding block 2 fixture that is fixedly connected with use with adjacent vertebral body; It is characterized in that: described artificial disc after arthroplasty also meets following requirement:
1. top shoe 1 main part is connected to one and is formed by top shoe sliding part 102 and top shoe soleplate part 103, and wherein: it is top shoe sliding area 101 that top shoe sliding part 102 is provided with for intermediate slider 3, coordinating the sliding area contacted away from the centre of top shoe soleplate part 103 1 sides; Top shoe sliding area 101 is by be slidably matched face 104 and be arranged on the be slidably matched top shoe of face 104 both sides of top shoe and extend upper recess surface 105 and form of the top shoe that is positioned at centre; For with sliding block 2, coordinating the top shoe sliding part edge surface 106 that forms bend and stretch/lateral bending position limiting structures to be arranged in the periphery of top shoe sliding part 102 away from the top shoe sliding area 101 of top shoe soleplate part 103 1 side sides;
Top shoe soleplate part 103 is provided with the top shoe fixture 107 that is fixedly connected with use for the vertebral body with adjacent on the side away from top shoe sliding part 102 1 sides;
2. sliding block 2 main parts are connected to one and are formed by sliding block sliding part 202 and sliding block soleplate part 203, and wherein: it is sliding block sliding area 201 that sliding block sliding part 202 is provided with for intermediate slider 3, coordinating the sliding area contacted away from the centre of sliding block soleplate part 203 1 sides; Sliding block sliding area 201 is by be slidably matched face 204 and be arranged on the be slidably matched sliding block of face 204 both sides of sliding block and extend concave surface 205 and form of the sliding block that is positioned at centre; For with top shoe 1, coordinating the sliding block sliding part edge surface 206 that forms position limiting structure to be arranged in the periphery of sliding block sliding part 202 away from the sliding block sliding area 201 of sliding block soleplate part 203 1 side sides;
Sliding block soleplate part 203 is provided with the sliding block fixture 207 that is fixedly connected with use for the vertebral body with adjacent on the side away from sliding block sliding part 202 1 sides;
3. the upper and lower surface of intermediate slider 3 is provided with respectively and top shoe face 104, the sliding block contacted face that is slidably matched of face 204 that is slidably matched that is slidably matched: intermediate slider upper mating surface 303, the intermediate slider lower mating surface 304 that slides that slides; On intermediate slider slides mating surface 303 and intermediate slider slide under the both sides of mating surface 304 be respectively arranged with respectively with top shoe extend upper recess surface 105, sliding block extend the corresponding intermediate slider of concave surface 205 extend on convex surface 305, intermediate slider extend under convex surface 306; On intermediate slider, the periphery in sliding area 301 and intermediate slider slip underneath zone 302 also is respectively arranged with respectively and top shoe sliding part edge surface 106, the intermediate slider top edge face 307 of sliding block sliding part edge surface 206 corresponding layouts, intermediate slider lower limb face 308;
4. top shoe face 104 and intermediate slider the two the face that is in contact with one another of upper mating surface 303 that slides that is slidably matched be all the part of the sphere that radius of curvature is identical, and one is outer surface, the interior contoured surface of another one; Sliding block face 204 and intermediate slider the two the face that is in contact with one another of lower mating surface 304 that slides that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, and another is interior contoured surface;
5. top shoe 1 and intermediate slider 3 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤9 °, sliding block 2 and intermediate slider 3 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it is≤9 °, top shoe 1 and sliding block 2 the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤18 °;
6. away from top shoe 1 and the top shoe soleplate part 103 of sliding block 2 contact surface one sides and the lateral surface centre of sliding block soleplate part 203, be respectively arranged with adjacent vertebral body and coordinate the outer convex surface 108 of the top shoe contacted, the outer convex surface 208 of sliding block.
Described artificial disc after arthroplasty meets one of following requirement or its certain combination:
The concrete structure that limits the two relative rotation angle scope on top shoe 1 and sliding block 2 on the horizontal direction at main matching surface center perpendicular to it meets following requirement: in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) of face 104 of top shoe, respectively be provided with respectively 1 top shoe and extend upper recess surface 105; Respectively be provided with respectively 1 sliding block and extend concave surface 205 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) of face 204 of sliding block; Accordingly, on intermediate slider slides mating surface 303 and intermediate slider slide under the both sides of mating surface 304 be respectively arranged with respectively with top shoe extend upper recess surface 105, sliding block extend the corresponding intermediate slider of concave surface 205 extend on convex surface 305, intermediate slider extend under convex surface 306; Intermediate slider extends upper convex surface 305, intermediate slider and extends lower convex surface 306 and stretch out to the described artificial disc after arthroplasty sagittal plane left and right sides respectively and be embedded into respectively top shoe and extend upper recess surface 105, sliding block and extend in the groove shape structure of concave surface 205 and the level that can carry out in certain limit is therein rotated relatively.
In described artificial disc prosthese, top shoe 1 and sliding block 2 form fit structures by means of intermediate slider 3, wherein: top shoe 1 with respect to sliding block 2 on the horizontal direction at main matching surface center perpendicular to it between the two the relative rotation angle area requirement be≤12 °; Wherein: for the rotary moveable scope of the artificial disc after arthroplasty of cervical vertebra≤12 °, for the rotary moveable scope of the artificial disc after arthroplasty of lumbar vertebra≤6 °;
The top shoe sliding part edge surface 106 of described artificial disc after arthroplasty on sagittal plane, sliding block sliding part edge surface 206 the two respectively and the angle α between intermediate slider top edge face 307, intermediate slider lower limb face 308≤15 °, realizing on sagittal plane bending and stretching movable full range of movement is 30 °, wherein for the bending and stretching range of activity and can reach 30 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 24 ° for the artificial disc after arthroplasty of lumbar vertebra;
Angle of release α≤10 ° between top shoe sliding part edge surface 106, sliding block sliding part edge surface 206 and the intermediate slider top edge face 307 of described artificial disc after arthroplasty on coronalplane, lower limb face 308, realize the range of activity of (lateral bending) on coronalplane maximum 20 °, wherein for the bending and stretching range of activity and can reach 20 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 12 ° for the artificial disc after arthroplasty of lumbar vertebra.
Top shoe sliding part 102 and top shoe soleplate part 103 meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
Sliding block sliding part 202 and sliding block soleplate part 203 meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material; The outer edge away from the artificial disc after arthroplasty center of intermediate slider 3 is provided with and prevents slippage structure 309, for to edge barrier structure one-sided or that bilateral is vertically widened; The material of top shoe sliding part 102, sliding block sliding part 202, intermediate slider 3 is polyether-ether-ketone resin (PEEK) or high purity carbon fiberreinforced polyether-ether-ketone resin material (CFR-PEEK); Titanium alloy Ti-Nb-Zr-the Sn of top shoe soleplate part 103, sliding block soleplate part 203 low elastic modulus.
10, according to one of them described artificial disc after arthroplasty of claim 7-9, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination: top shoe face 104, sliding block face 204, intermediate slider upper mating surface 303 and the intermediate slider lower mating surface 304 side shifting 2-8mm that supports or opposes from the prosthese center on sagittal plane that slides that slides that is slidably matched that is slidably matched; Angle of release α between top shoe sliding part edge surface 106 and intermediate slider top edge face 307≤15 °, the angle of release α between sliding block sliding part edge surface 206 and intermediate slider lower limb face 308≤15 °; Top shoe edge surface 106, sliding block edge surface 206 are corresponding with angle of release α with the distance between the intermediate slider edge surface, and the flexion angles the displacement jointly the party made progress is controlled within the required range.Above-mentioned angle of release α and distance are different on the different directions of described artificial disc after arthroplasty; Distance is difficult for quantitative description herein, and it is relevant with the diameter on certain direction of whole artificial disc, with to reach to bend and stretch angle also relevant;
Also be provided with not X-ray or the labelling of X-ray thoroughly thoroughly in described artificial disc after arthroplasty; Labelling is so that reach postoperative inspection and adjustment in operation process; For and the contact surface of the top shoe soleplate part 103 that is in contact with one another of adjacent vertebral bodies or sliding block soleplate part 203 carry out hydroxyapatite material (HA) coating by plasma spraying method or other method and process; Described top shoe and contiguous terminal plate of vertebral body stationary device 107 and/or sliding block and contiguous terminal plate of vertebral body stationary device 207 are specially following several one or a combination set of: the screw duct of the outside bur structure of wedge angle, prominent sour jujube, diagonal; The concrete structure of described " prominent sour jujube " meets following requirement: offer groove on adjacent vertebral body sclerotin, coordinate the fin of installation in the correspondence position setting of the artificial disc after arthroplasty with the corresponding contact of this groove with groove;
Following position requires to carry out the circular arc processing of rounding: be slidably matched face 104 and top shoe of top shoe extends upper recess surface 105 junctions, the top shoe that directly connects or connect by transition face extends the corner of the syndeton between upper recess surface 105 and top shoe sliding part edge surface 106, the connection corner between each joint face of outward flange of top shoe sliding part edge surface 106 and/or top shoe soleplate part 103; Be slidably matched face 204 and sliding block of sliding block extends concave surface 205 junctions, the sliding block extension concave surface 205 that directly connects or connects by transition face and the corner of the syndeton between sliding block sliding part edge surface 206; Connection corner between each joint face of outward flange of sliding block sliding part edge surface 206 and/or sliding block soleplate part 203; Intermediate slider be slidably matched top 303 and intermediate slider extend upper convex surface 305 junctions, the intermediate slider that directly connects or connects by transition face extends the above corner of syndeton between convex surface 305 and intermediate slider top edge face 307; Intermediate slider be slidably matched following 304 and intermediate slider extend lower convex surface 306 junctions, the corner of syndeton between convex surface 306 and intermediate slider lower limb face 308 under the intermediate slider that directly connects or connects by transition face extends;
The monnolithic case of described artificial disc after arthroplasty is following one of several: circular, oval, semicircle, trapezoidal; The sagittal diameter of described artificial disc after arthroplasty is 8-50mm, and transverse diameter is 10-60mm, is highly 5-30mm, and the ratio of transverse diameter and sagittal diameter is following one of several: 4: 3,5: 3,2: 1; The anterior and posterior height of top shoe soleplate part 103 and sliding block soleplate part 203 is inconsistent, can rebuild the physiological camber of cervical vertebra and lumbar vertebra.

Claims (10)

1. an artificial disc after arthroplasty, for substituting the intervertebral disc of cervical vertebra and lumbar vertebra fully, by top shoe (1) and these two functional part mix proportions of sliding block (2), on top shoe (1) and sliding block (2), be respectively arranged with for coordinating the sliding area of contact between the two; Top shoe (1) also is provided with on sliding block (2) fixture that is fixedly connected with use with adjacent vertebral body; It is characterized in that: described artificial disc after arthroplasty also meets following requirement:
1. top shoe (1) main part is by top shoe sliding part (102) and top shoe soleplate part (103) formation that is connected to one, wherein: it is top shoe sliding area (101) that top shoe sliding part (102) is provided with for sliding block (2), coordinating the sliding area contacted away from the centre of top shoe soleplate part (103) one sides; Top shoe sliding area (101) is by be slidably matched face (104) and be arranged on the be slidably matched top shoe of face (104) both sides of top shoe and extend upper recess surface (105) and form of the top shoe that is positioned at centre; For and sliding block (2) coordinate the top shoe sliding part edge surface (106) of bend and stretch/lateral bending of formation position limiting structure to be arranged in the periphery of top shoe sliding part (102) away from the top shoe sliding area (101) of top shoe soleplate part (103) one side sides;
Be provided with the top shoe fixture (107) that is fixedly connected with use for the vertebral body with adjacent on the side of top shoe soleplate part (103) away from top shoe sliding part (102) one sides;
2. sliding block (2) main part is by sliding block sliding part (202) and sliding block soleplate part (203) formation that is connected to one, wherein: it is sliding block sliding area (201) that sliding block sliding part (202) is provided with for top shoe (1), coordinating the sliding area contacted away from the centre of sliding block soleplate part (203) one sides; Sliding block sliding area (201) is by be slidably matched face (204) and be arranged on the be slidably matched sliding block of face (204) both sides of sliding block and extend lower convex surface (205) and form of the sliding block that is positioned at centre; For and top shoe (1) coordinate the sliding block sliding part edge surface (206) of formation position limiting structure to be arranged in the periphery of sliding block sliding part (202) away from the sliding block sliding area (201) of sliding block soleplate part (203) one side sides;
Be provided with the sliding block fixture (207) that is fixedly connected with use for the vertebral body with adjacent on the side of sliding block soleplate part (203) away from sliding block sliding part (202) one sides;
3. top shoe face (104) and sliding block the two the face that is in contact with one another of face (204) that is slidably matched that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, and another is interior contoured surface;
4. top shoe (1) and sliding block (2) the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤18 °;
5. away from top shoe (1) and the top shoe soleplate part (103) of sliding block (2) contact surface one side and the lateral surface centre of sliding block soleplate part (203), be respectively arranged with adjacent vertebral body and coordinate the outer convex surface (108) of the top shoe contacted, the outer convex surface (208) of sliding block.
2. artificial disc after arthroplasty according to claim 1 is characterized in that:
The upper concrete structure that limits the two relative rotation angle scope on the horizontal direction at main matching surface center perpendicular to it of top shoe (1) and sliding block (2) meets following requirement:
Respectively be provided with respectively 1 top shoe and extend upper recess surface (105) in the be slidably matched both sides of face (104) of top shoe; Accordingly, sliding block be slidably matched the both sides of face (204) respectively be provided with respectively 1 sliding block extend under convex surface (205); That is: sliding block extends that lower convex surface (205) stretches out and be embedded into to the described artificial disc after arthroplasty sagittal plane left and right sides in two groove shape structures that top shoe extends upper recess surface (105) and can extend and carry out level in upper recess surface (105) and relatively rotate at top shoe.
3. artificial disc after arthroplasty according to claim 2, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
Top shoe (1) and sliding block (2) the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it is≤12 °, it is 12 ° that realization horizontally rotates the maximum angle scope, wherein: for the rotary moveable scope of the artificial disc after arthroplasty of cervical vertebra≤12 °, for the rotary moveable scope of the artificial disc after arthroplasty of lumbar vertebra≤6 °;
The top shoe sliding part edge surface (106) of described artificial disc after arthroplasty on sagittal plane and the angle α of sliding block sliding part edge surface (206)≤30 °, realizing on sagittal plane bending and stretching movable maximum angle range of activity is 30 °, wherein: for the bending and stretching range of activity and can reach 30 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 24 ° for the artificial disc after arthroplasty of lumbar vertebra;
The top shoe sliding part edge surface (106) of described artificial disc after arthroplasty on coronalplane and the angle of release α of sliding block sliding part edge surface (206)≤20 °, the angular range of realizing lateral bending range of activity maximum on coronalplane is 20 °, wherein: for the bending and stretching range of activity and can reach 20 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 12 ° for the artificial disc after arthroplasty of lumbar vertebra.
4. artificial disc after arthroplasty according to claim 3, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
Top shoe sliding part (102) and top shoe soleplate part (103) meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
Sliding block sliding part (202) and sliding block soleplate part (203) meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
The material of top shoe sliding part (102), sliding block sliding part (202) is polyether-ether-ketone resin or high purity carbon fiberreinforced polyether-ether-ketone resin material; Titanium alloy Ti-Nb-Zr-Sn that the material of top shoe soleplate part (103), sliding block soleplate part (203) is low elastic modulus.
5. according to one of them described artificial disc after arthroplasty of claim 2-4, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
Top shoe face (104) and sliding block face (204) the side shifting 2-8mm that supports or opposes from the prosthese center on sagittal plane that is slidably matched that is slidably matched;
Also be provided with not X-ray or the labelling of X-ray thoroughly thoroughly in described artificial disc after arthroplasty;
For and the contact surface of the top shoe soleplate part (103) that is in contact with one another of adjacent vertebral bodies or sliding block soleplate part (203) use plasma spraying method to carry out the preparation of hydroxyapatite material coating;
Described top shoe fixture (107), sliding block fixture (207) are specially following several one or a combination set of: the screw duct of the outside bur structure of wedge angle, prominent sour jujube, diagonal; The concrete structure of described " prominent sour jujube " meets following requirement: offer groove on adjacent vertebral body sclerotin, coordinate the fin of installation in the correspondence position setting of the artificial disc after arthroplasty with the corresponding contact of this groove with groove;
Following position requires to carry out the circular arc processing of rounding: top shoe be slidably matched face (104) and top shoe extension upper recess surface (105) junction, the top shoe that directly connects or connect by transition face extends the corner of the syndeton between upper recess surface (105) and top shoe sliding part edge surface (106), the connection corner between each joint face of outward flange of top shoe sliding part edge surface (106) and/or top shoe soleplate part (103); Be slidably matched face (204) and sliding block of sliding block extends lower convex surface (205) junction, the corner of the syndeton under the sliding block that directly connects or connects by transition face extends between convex surface (205) and sliding block sliding part edge surface (206); Connection corner between each joint face of outward flange of sliding block sliding part edge surface (206) and/or sliding block soleplate part (203);
The monnolithic case of described artificial disc after arthroplasty is following one of several: circular, oval, semicircle, trapezoidal; The sagittal diameter of described artificial disc after arthroplasty is 8-50mm, and transverse diameter is 10-60mm, is highly 5-30mm, and the ratio of transverse diameter and sagittal diameter is following one of several: 4: 3,5: 3,2: 1; The anterior and posterior height of top shoe soleplate part (103) and sliding block soleplate part (203) is inconsistent, can rebuild the physiological camber of cervical vertebra and lumbar vertebra.
6. an artificial disc after arthroplasty, for substituting the intervertebral disc of cervical vertebra and lumbar vertebra fully, by top shoe (1), sliding block (2), these three functional part mix proportions of intermediate slider (3), intermediate slider (3) is arranged between the above two and it is in contact with one another to coordinate with the former two respectively and forms sliding area; Top shoe (1) also is provided with on sliding block (2) fixture that is fixedly connected with use with adjacent vertebral body; It is characterized in that: described artificial disc after arthroplasty also meets following requirement:
1. top shoe (1) main part is by top shoe sliding part (102) and top shoe soleplate part (103) formation that is connected to one, wherein: it is top shoe sliding area (101) that top shoe sliding part (102) is provided with for intermediate slider (3), coordinating the sliding area contacted away from the centre of top shoe soleplate part (103) one sides; Top shoe sliding area (101) is by be slidably matched face (104) and be arranged on the be slidably matched top shoe of face (104) both sides of top shoe and extend upper recess surface (105) and form of the top shoe that is positioned at centre; For and sliding block (2) coordinate the top shoe sliding part edge surface (106) of bend and stretch/lateral bending of formation position limiting structure to be arranged in the periphery of top shoe sliding part (102) away from the top shoe sliding area (101) of top shoe soleplate part (103) one side sides;
Be provided with the top shoe fixture (107) that is fixedly connected with use for the vertebral body with adjacent on the side of top shoe soleplate part (103) away from top shoe sliding part (102) one sides;
2. sliding block (2) main part is by sliding block sliding part (202) and sliding block soleplate part (203) formation that is connected to one, wherein: it is sliding block sliding area (201) that sliding block sliding part (202) is provided with for intermediate slider (3), coordinating the sliding area contacted away from the centre of sliding block soleplate part (203) one sides; Sliding block sliding area (201) is by be slidably matched face (204) and be arranged on the be slidably matched sliding block of face (204) both sides of sliding block and extend concave surface (205) and form of the sliding block that is positioned at centre; For and top shoe (1) coordinate the sliding block sliding part edge surface (206) of formation position limiting structure to be arranged in the periphery of sliding block sliding part (202) away from the sliding block sliding area (201) of sliding block soleplate part (203) one side sides;
Be provided with the sliding block fixture (207) that is fixedly connected with use for the vertebral body with adjacent on the side of sliding block soleplate part (203) away from sliding block sliding part (202) one sides;
3. the upper and lower surface of intermediate slider (3) is provided with respectively and top shoe face (104), the sliding block contacted face that is slidably matched of face (204) that is slidably matched that is slidably matched: intermediate slider upper mating surface (303), the intermediate slider lower mating surface (304) that slides that slides; On intermediate slider slides mating surface (303) and intermediate slider slide the both sides of lower mating surface (304) be respectively arranged with respectively extend upper recess surface (105) with top shoe, sliding block extends the corresponding intermediate slider of concave surface (205) and extends convex surface (306) under above convex surface (305), intermediate slider extension; The periphery in sliding area on intermediate slider (301) and intermediate slider slip underneath zone (302) also is respectively arranged with respectively and top shoe sliding part edge surface (106), the intermediate slider top edge face (307) of the corresponding layout of sliding block sliding part edge surface (206), intermediate slider lower limb face (308);
4. top shoe face (104) and intermediate slider the two the face that is in contact with one another of upper mating surface (303) that slides that is slidably matched be all the part of the sphere that radius of curvature is identical, and one is outer surface, the interior contoured surface of another one; Sliding block face (204) and intermediate slider the two the face that is in contact with one another of lower mating surface (304) that slides that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, and another is interior contoured surface;
5. top shoe (1) and intermediate slider (3) the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤9 °, sliding block (2) and intermediate slider (3) the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it is≤9 °, top shoe (1) and sliding block (2) the two relative rotation angle area requirement on the horizontal direction at main matching surface center perpendicular to it be≤18 °;
6. away from top shoe (1) and the top shoe soleplate part (103) of sliding block (2) contact surface one side and the lateral surface centre of sliding block soleplate part (203), be respectively arranged with adjacent vertebral body and coordinate the outer convex surface (108) of the top shoe contacted, the outer convex surface (208) of sliding block.
7. artificial disc after arthroplasty according to claim 6, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
The upper concrete structure that limits the two relative rotation angle scope on the horizontal direction at main matching surface center perpendicular to it of top shoe (1) and sliding block (2) meets following requirement:
Respectively be provided with respectively 1 top shoe and extend upper recess surface (105) in the be slidably matched both sides of face (104) of top shoe; Respectively be provided with respectively 1 sliding block and extend concave surface (205) in the be slidably matched both sides of face (204) of sliding block;
Accordingly, on intermediate slider slides mating surface (303) and intermediate slider slide the both sides of lower mating surface (304) be respectively arranged with respectively extend upper recess surface (105) with top shoe, sliding block extends the corresponding intermediate slider of concave surface (205) and extends convex surface (306) under above convex surface (305), intermediate slider extension;
Intermediate slider extends upper convex surface (305), intermediate slider and extends lower convex surface (306) and stretch out to the described artificial disc after arthroplasty sagittal plane left and right sides respectively and be embedded into respectively top shoe and extend upper recess surface (105), sliding block and extend in the groove shape structure of concave surface (205) and can carry out therein level and relatively rotate.
8. artificial disc after arthroplasty according to claim 7, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
In described artificial disc prosthese, top shoe (1) and sliding block (2) form fit structure by means of intermediate slider (3), top shoe (1) with respect to sliding block (2) on the horizontal direction at main matching surface center perpendicular to it between the two the relative rotation angle area requirement be≤12 °; Wherein: for the rotary moveable scope of the artificial disc after arthroplasty of cervical vertebra≤12 °, for the rotary moveable scope of the artificial disc after arthroplasty of lumbar vertebra≤6 °;
The top shoe sliding part edge surface (106) of described artificial disc after arthroplasty on sagittal plane, sliding block sliding part edge surface (206) the two respectively and the angle α between intermediate slider top edge face (307), intermediate slider lower limb face (308)≤15 °, realizing on sagittal plane bending and stretching movable full range of movement is 30 °, wherein for the bending and stretching range of activity and can reach 30 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 24 ° for the artificial disc after arthroplasty of lumbar vertebra;
Angle of release α≤10 ° between top shoe sliding part edge surface (106), sliding block sliding part edge surface (206) and the intermediate slider top edge face (307) of described artificial disc after arthroplasty on coronalplane, lower limb face (308), realize the range of activity of (lateral bending) on coronalplane maximum 20 °, wherein for the bending and stretching range of activity and can reach 20 ° of the artificial disc after arthroplasty of cervical vertebra, bending and stretching range of activity and can reach 12 ° for the artificial disc after arthroplasty of lumbar vertebra.
9. artificial disc after arthroplasty according to claim 8, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
Top shoe sliding part (102) and top shoe soleplate part (103) meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
Sliding block sliding part (202) and sliding block soleplate part (203) meet one of following requirement: one, and the two is the Split type structure part that can fit together, and is non-dismountable or detachable block, utilizes each other draw-in groove or screw to be fixedly connected with; Its two, the two integral structure component that is identical material;
The outer edge away from the artificial disc after arthroplasty center of intermediate slider (3) is provided with and prevents slippage structure (309), for to edge barrier structure one-sided or that bilateral is vertically widened;
The material of top shoe sliding part (102), sliding block sliding part (202), intermediate slider (3) is polyether-ether-ketone resin or high purity carbon fiberreinforced polyether-ether-ketone resin material; Titanium alloy Ti-Nb-Zr-the Sn of top shoe soleplate part (103), sliding block soleplate part (203) low elastic modulus.
10. according to one of them described artificial disc after arthroplasty of claim 7-9, it is characterized in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
Top shoe face (104), sliding block face (204), intermediate slider upper mating surface (303) and intermediate slider lower mating surface (304) side shifting 2-8mm that supports or opposes from the prosthese center on sagittal plane that slides that slides that is slidably matched that is slidably matched;
Also be provided with not X-ray or the labelling of X-ray thoroughly thoroughly in described artificial disc after arthroplasty;
For and the top shoe soleplate part (103) that is in contact with one another of adjacent vertebral bodies or the contact surface of sliding block soleplate part (203) carry out the processing of hydroxyapatite material coating by plasma spraying method or other method;
Described top shoe and contiguous terminal plate of vertebral body stationary device (107) and/or sliding block and contiguous terminal plate of vertebral body stationary device (207) are specially following several one or a combination set of: the screw duct of the outside bur structure of wedge angle, prominent sour jujube, diagonal; The concrete structure of described " prominent sour jujube " meets following requirement: offer groove on adjacent vertebral body sclerotin, coordinate the fin of installation in the correspondence position setting of the artificial disc after arthroplasty with the corresponding contact of this groove with groove;
Following position requires to carry out the circular arc processing of rounding: top shoe be slidably matched face (104) and top shoe extension upper recess surface (105) junction, the top shoe that directly connects or connect by transition face extends the corner of the syndeton between upper recess surface (105) and top shoe sliding part edge surface (106), the connection corner between each joint face of outward flange of top shoe sliding part edge surface (106) and/or top shoe soleplate part (103); Be slidably matched face (204) and sliding block of sliding block extends concave surface (205) junction, the sliding block extension concave surface (205) that directly connects or connects by transition face and the corner of the syndeton between sliding block sliding part edge surface (206); Connection corner between each joint face of outward flange of sliding block sliding part edge surface (206) and/or sliding block soleplate part (203); Above intermediate slider is slidably matched, (303) and intermediate slider extend upper convex surface (305) junction, and the intermediate slider that directly connects or connect by transition face extends the corner of syndeton between upper convex surface (305) and intermediate slider top edge face (307); Below intermediate slider is slidably matched, (304) and intermediate slider extend lower convex surface (306) junction, and the intermediate slider that directly connects or connect by transition face extends the corner of syndeton between lower convex surface (306) and intermediate slider lower limb face (308);
The monnolithic case of described artificial disc after arthroplasty is following one of several: circular, oval, semicircle, trapezoidal; The sagittal diameter of described artificial disc after arthroplasty is 8-50mm, and transverse diameter is 10-60mm, is highly 5-30mm, and the ratio of transverse diameter and sagittal diameter is following one of several: 4: 3,5: 3,2: 1; The anterior and posterior height of top shoe soleplate part (103) and sliding block soleplate part (203) is inconsistent, can rebuild the physiological camber of cervical vertebra and lumbar vertebra.
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