CN103417313B - A kind of artificial neck lumbar intervertebral disc - Google Patents
A kind of artificial neck lumbar intervertebral disc Download PDFInfo
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- CN103417313B CN103417313B CN201210154761.3A CN201210154761A CN103417313B CN 103417313 B CN103417313 B CN 103417313B CN 201210154761 A CN201210154761 A CN 201210154761A CN 103417313 B CN103417313 B CN 103417313B
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Classifications
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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
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Neurology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
A kind of artificial disc after arthroplasty, for substituting the intervertebral disc of cervical vertebra and lumbar vertebra completely, it is made up of top shoe (1), sliding block (2) or the former two and intermediate slider (3) collectively constitute, for the previous case, top shoe (1) with sliding block (2) are separately provided for coordinating therebetween the sliding area contacted；For latter event, intermediate slider (3) is arranged between top shoe (1) and sliding block (2) and its cooperation that contacts with each other with the former two respectively constitutes sliding area.The present invention provides sufficient smooth contact interface to ensure the smooth movement of long-term stability for prosthese motion, and described prosthese will adopt new titanium alloy and polyetheretherketonematerials materials to make, and make the mechanical property lasting stability of prosthese.Prosthese of the present invention selects have obvious novelty and performance advantage in structural design and material, has fabulous application prospect in the art.
Description
Technical field
The present invention relates to the structural design of orthopaedic medical treatment articles for use and applied technical field, specifically provide the artificial disc after arthroplasty of a kind of intervertebral disc for substituting human cervical spine and/or lumbar vertebra completely.
Background technology
Cervical vertebra caused by a variety of causes and the intervertebral disc disorder of lumbar vertebra destroy the integrity of intervertebral disc structure; intervertebral disc is made to lose the function of its original motion and bearing load; bring the symptom such as pain, delayed ischemic neurological deficits, have a strong impact on the daily routines of people.When the disc disease expectant treatment of cervical vertebra and lumbar vertebra is invalid, operative treatment should be carried out.Operation method conventional at present includes intercalated disc resection of nucleus pulposus and disc excision bone graft fusion etc., but it is no matter the former or the latter proper motion and bearing function of all destroying lesion segment, have also been changed the biomechanics state of adjacent segment intervertebral disc and other tissue simultaneously, result in Adjacent segment degeneration aggravation, therefore its late result is all not good enough.
For the function of reconstruction of intervertebral disc, recovering the physiological status of spinal column, people produce the thought of invention artificial disc after arthroplasty.Multiple related-art technology such as scholars' bond material science, biomechanics and industrial design in recent decades, have carried out design and the application of many artificial disc after arthroplasties.
The principle of load the following aspects is mainly answered in the design of current artificial disc after arthroplasty: one, material property: body implant material is in biology, requirement must have good biocompatibility, avirulence, non-carcinogenesis, corrosion resistance, will not causing the tissue reaction of local after the implantation, this is the basic demand of artificial disc after arthroplasty material.From the viewpoint of biomechanics, owing to intervertebral disc to bear the multiple loads such as compression, bending, torsion, shearing under physiological status, being the load activity axle center of FSU, therefore material must also have the performance conditions such as high intensity, wearability, fatigue resistance.The soleplate part of artificial disc after arthroplasty contacts with terminal plate of vertebral body sclerotin, and the elastic modelling quantity of its contact interface should mate as far as possible, and namely the elastic modelling quantity of soleplate part should be close with osseous tissue, so just can be prevented effectively from the depression of implants and loosen；Two, kinesiology: the motor function of the human intervertebral disc of normal configuration is sufficiently complex, it is possible to carry out simple or associating motion in a plurality of directions, and the spinal column of different segment, its range of movement and conjugate movement characteristic are different.The physiological activity performance of displacement sections should be recovered during design artificial disc after arthroplasty as far as possible, including range of activity in a plurality of directions, axis of rotation, make artificial disc after arthroplasty Tong Bu with the spinal motion of contiguous multiple sections；Three, implants is fixing: the fixing of artificial disc after arthroplasty includes at once fixing and fixing for a long time.At once fixing adopt is mechanically fixed more, chimeric with sclerotin around and obtain temporary transient fixing by screw, hook, thorn, bolt etc., at once fixing purpose is for fixing the offer time for a long time, if can not obtain effective permanent fixing, at once fixing eventually failure, therefore obtains effective permanent fixing particularly important.Permanent fixing is that bone tissue growth by soleplate enters the soleplate part contact surface of artificial disc after arthroplasty and realizes, therefore the surface of the contact surface of soleplate up and down of prosthese needs to process accordingly, process including screw thread, hydroxyapatite coating layer processes, and 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 that safety easy for installation, operation wound are little, be prone to remove and prosthese is overhauled.
Existing kinds of artificial intervertebral disk prosthesis, can be divided into 3 kinds according to the difference of composition material: i.e. nonmetal, metal and both coalitions by artificial lumbar disc at present.
Nonmetal prosthese have the advantages that mechanical performance is similar to human intervertebral disc, its relatively low elastic modelling quantity is closer to the mechanical characteristic of intervertebral disc.Implant includes one or more elastic with cushioning effect to imitate vertebral pulp and the fibrous ring of intervertebral disc.Lee etc. are (referring to list of references 1LeeCK, LangranaNA, ParsonsJR, etal.Developmentofaprostheticintervertebraldisc.Spine, 1991；null16:S253-255. referring to list of references 2Vuono-HawkinsM,LangranaNA,LeeCK,etal.Materialsanddesignconceptsforanintervertebraldiscspacer.II.Multidurometercompositedesign.JApplBiomater.1995,6:117-123.) devise a kind of nonmetal prosthese，Its center is that soft rubber elastomer core is to imitate the vertebral pulp of intervertebral disc，6～15 layers of IR fiber band of different directions are then passed through in order to imitate the function of fibrous ring in periphery，This prosthese can imitate the vertebral pulp of pressurized and the human intervertebral disc of pressurized torsion.But due to the limited strength of prosthetic material, and lacking the satisfied method that fixedly secures, current this kind of nonmetallic materials artificial disc after arthroplasty is of limited application.
The advantage of metal material artificial lumbar disc is in that it has good biocompatibility, high intensity, resisting fatigue, resistance to wears, is easily installed the performance advantages such as fixing, and the metal material of selection mainly has rustless steel, titanium alloy, vitallium etc..But owing to the elastic modelling quantity of metal prostheses material is significantly larger than human body bone, forming heavily stressed distribution, cause the depression of prosthese on the artificial disc after arthroplasty contact surface with terminal plate of vertebral body, this becomes all-metal prosthese needs improvements.The disc replacement thing used first in human history is all-metal construction.Fernstrom in 1966 (referring to list of references 3FernstromU.Arthroplastywithintercorporalendoprothesisin herniateddiscandinpainfuldisc.ActaChirScandSuppl, 1966；357:154-159.) be reported in 125 example cervical vertebras and lumbar discectomy after fill in the spherical prosthese of rustless steel of a diameter 10～16mm, early stage thinks the effect having stable spinal column and maintenance activity, but Follow-up After finds that metal ball major part is absorbed in vertebral body for 4～7 years, only the disc height of 12% is 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, the high polish technology adopting artificial hip joint is made (referring to list of references 4MathewsHH, LehuecJC, FriesemT, etal.DesignrationaleandbiomechanicsofMaverickTotalDiscar throplastywithearlyclinicalresults.SpineJ, 2004；4:268S-275S.).Prosthese includes two parts, and global design designs for ball-and-socket joint, qualified through test in laboratory, and in 2003 by the approval of U.S. FDA, has carried out clinical experimental study.By the follow-up investigation of 7 example patients is found, short run effect is substantially better than the patient using Invasive lumbar fusion device (referring to list of references 4MathewsHH, LehuecJC, FriesemT, etal.DesignrationaleandbiomechanicsofMaverickTotalDiscar throplastywithearlyclinicalresults.SpineJ, 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 in 2003 by the approval of U.S. FDA, carry out clinical experimental study (referring to list of references 5ValdevitA, ErricoTJ.DesignandevaluationoftheFlexiCoremetal-on-metal intervertebraldiscprosthesis.SpineJ, 2004；4:276S-288S.).This prosthese is combined into by four member in tight, devises a ball-and-socket joint between upper and lower cover plates, has little brake area in order to limit rotation in its spherical gliding surfaces, and this prosthese disclosure satisfy that lumbar vertebra range of activity, again limit the over-activity of lumbar vertebra.
In order to play the advantage of metal and nonmetallic materials, mutually making up material property defect, many scholars adopt the method for the two combination when designing artificial disc after arthroplasty, devise the Novel artificial intervertebral disk prostheses such as Prodisc-L, Prodisc-C, Charite.The Marnay of France (referring to list of references 6MarnayT.Prosthesisforintervertebraldiscsandinstrumentsf orimplantingit.USPatent, 1994；5:314-324.) devise the prosthese of a kind of cap cup structure, called after ProDisc artificial lumbar disc.Prosthese entered and repeatedly improved, cervical vertebra and lumbar vertebra are can apply at present, Prodisc-L is used for lumbar vertebra, Prodisc-C is used for cervical vertebra, both is made up of upper and lower metal end plate and middle polyethylene core, is functionally 2-component prosthese, designs different height and sections curvature for different parts, bending and stretching and control within the specific limits with lateral bending activity, axial-rotation is uncontrolled.nullIn Prodisc-L artificial disc replacement's 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 above spinal fusion group，When 24 months, the artificial disc displacement patient of 93.7% remained the range of activity of average 7.7 ° (referring to list of references 7ZiglerJ,DelamarterR,SpivakJM,etal.Resultsoftheprospective,randomized,multicenterFoodandDrugAdministrationinvestigationaldeviceexemptionstudyoftheProDisc-Ltotaldiscreplacementversuscircumferentialfusionforthetreatmentof1-leveldegenerativediscdisease.Spine,2007,32(11):1155-1163).Prodisc-C has carried out randomized clinical control study also by U.S. FDA approval, 209 patients participate in test, 106 carry out cervical discectomy interbody fusion, 103 carry out artificial disc replacement, the effect of the Follow-up results display artificial disc after arthroplasty displacement of 2 years is at least suitable with fusion, even better.null(referring to list of references 8MurreyD,JanssenM,DelamarterR,etal.Resultsoftheprospective,randomized,controlledmulticenterFoodandDrugAdministrationinvestigationaldeviceexemptionstudyoftheProDisc-Ctotaldiscreplacementversusanteriordiscectomyandfusionforthetreatmentof1-levelsymptomaticcervicaldiscdisease.SpineJ,2009；9(4):275-86.)
In nineteen eighty-two, Charite institute in Berlin devises SBCharite artificial lumbar disc to KurtSchell-nack and Buttner-Janz, within 1984, has carried out clinical practice first.This artificial disc after arthroplasty is improved further subsequently, becomes current form.It is made up of the polyethylene slip core of two pieces of symmetrical, ovate cochrome cover plates and a super high molecular weight, relies on the pointed tooth on cover plate to be fixed on vertebral body.Slip core is biconvex shape, is placed between upper and lower cover plates, and outside is wound with a becket and positions in order to x-ray.Lack, for metal cover board, the shortcoming that surface treatment, Bone Ingrowth are not good, also coat pure titanium-hydroxyapatite layer in lid surface.nullIt is currently external extensive use，Clinical research comparatively deep a kind of prosthese (referring to list of references 9GeislerFH,BlumenthalSL,GuyerRD,etal.Neurologicalcomplicationsoflumbarartificialdiscreplacementandcomparisonofclinicalresultswiththoserelatedtolumbararthrodesisintheliterature:resultsofamulticenter,prospective,randomizedinvestigationaldeviceexemptionstudyofChariteintervertebraldisc.JNeurosurgSpine,2004；1:143-154.).Caspi etc. (referring to list of references 10CaspiI, LevinkopfM, NerubayJ.Resultsoflumbardiskprosthesisafterafollow-upper iodof48months.IsrMedAssocJ, 2003；5:9-11.) reporting 20 examples and adopt 2 years Follow-up results of SBCharite artificial lumbar disc treatment lumbar intervertebral disc dissolving time patient, 80% patient obtains satisfactory effect.Guyer etc. are (referring to list of references 11GuyerRD, McAfeePC, HochschulerSH, etal.ProspectiverandomizedstudyoftheChariteartificialdis c:Datafromtwoinvestigationalcenters.SpineJ, 2004；4:252S-259S.) 144 example lumbar retrogression patients being studied, wherein 100 examples adopt the treatment of Charite artificial intervertebral disc, and 44 examples adopt the treatment of BAK anterior stabilization, follow up a case by regular visits to 2 years, judge therapeutic effect with Oswestry standards of grading.Result shows that two groups of therapeutic effect are not significantly different from.
Artificial disc after arthroplasty displacement has good potential applicability in clinical practice, but owing to physiological structure and the biomechanical property of intervertebral disc are extremely complex, and lacking 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 at an early stage.Along with updating of artificial lumbar disc design is summed up with the continuous of clinical practice, on the strict basis holding indication, artificial intervertebral disc will play due effect on clinical treatment.
This situation in view of this technical field current, a kind of rational in infrastructure, Novel artificial intervertebral disk prosthese that material property is outstanding of the highly desirable acquisition of people, so that being better 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 completely, the disc disease for the treatment of cervical vertebra and lumbar vertebra.
Summary of the invention
It is an object of the invention to provide a kind of artificial disc after arthroplasty that can substitute cervical vertebra and intervertebral disc of lumbar vertebra completely, for treating conservative invalid cervical vertebra and lumbar intervertebral disc disease and carrying out artificial disc after arthroplasty replacement.By to this prosthese adaptability design at cervical vertebra and lumbar vertebra different segment structure and exercise performance, can reasonably recover the form (physiological camber) of place sections, range of activity and bearing function, thus reaching desirable artificial disc after arthroplasty replacement result.It is not only able to removal based on the artificial disc replacement of artificial neck lumbar intervertebral disc of the present invention and causes pain and handicapped intervertebral disc, remain physiological movement and the bearing function of operated level simultaneously, keep the stability of spinal column and activeness, it is to avoid closing on sections stress excessively increases caused intervertebral disc and accelerate regression.
One artificial disc after arthroplasty of the present invention, for substituting the intervertebral disc of cervical vertebra and lumbar vertebra completely, is specifically divided into two big classes:
The first kind is two-piece (whole artificial disc after arthroplasty is mainly made up of two structural members), it specifically forms with top shoe 1 and sliding block 2 the two functional part, is separately provided for coordinating therebetween the sliding area contacted on top shoe 1 with sliding block 2；Top shoe 1 and sliding block 2 are additionally provided with and fix the fixing device connected 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 is constituted by top shoe sliding part 102 and top shoe soleplate part 103, wherein: top shoe sliding part 102 is provided with for coordinating the sliding area and top shoe sliding area 101 contacted with sliding block 2 away from the centre of top shoe soleplate part 103 side；Top shoe sliding area 101 is slidably matched by the top shoe at centrally located place face 104 and be arranged on the be slidably matched top shoe of both sides, face 104 of top shoe and extend upper recess surface 105 and constitute；For coordinate with sliding block 2 constitute bend and stretch/the top shoe sliding part edge surface 106 of lateral bending position limiting structure is arranged in the top shoe sliding part 102 periphery away from the top shoe sliding area 101 of side, top shoe soleplate part 103 side；
Top shoe soleplate part 103 is provided with on the side away from top shoe sliding part 102 side for fixing the fixing device 107 of the top shoe connected with adjacent vertebral body；
2. sliding block 2 main part is connected to one is constituted by sliding block sliding part 202 and sliding block soleplate part 203, wherein: sliding block sliding part 202 is provided with for coordinating the sliding area and sliding block sliding area 201 contacted with top shoe 1 away from the centre of sliding block soleplate part 203 side；Sliding block sliding area 201 is slidably matched by the sliding block at centrally located place face 204 and be arranged on the be slidably matched sliding block of both sides, face 204 of sliding block and extend lower convex surface 205 and constitute；For coordinating the sliding block sliding part edge surface 206 constituting position limiting structure to be arranged in the sliding block sliding part 202 periphery away from the sliding block sliding area 201 of side, sliding block soleplate part 203 side with top shoe 1；
Sliding block soleplate part 203 is provided with on the side away from sliding block sliding part 202 side for fixing the fixing device 207 of the sliding block connected with adjacent vertebral body；
3. top shoe be slidably matched with the sliding block face that contacts with each other in both faces 204, face 104 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 Internal periphery face；
4. top shoe 1 and sliding block 2 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤18 °；
5. in the lateral surface centre away from the top shoe soleplate part 103 of top shoe 1 and sliding block 2 contact surface side and sliding block soleplate part 203, it is respectively arranged with and coordinates top shoe arcuate surface 108, the sliding block arcuate surface 208 contacted with adjacent vertebral body.
Described artificial disc after arthroplasty, also includes the description below and requires:
The concrete structure limiting the two relative rotation angle scope on top shoe 1 and sliding block 2 in the horizontal direction being perpendicular to its main matching surface center meets following requirement:
It is each provided with 1 top shoe respectively extends upper recess surface 105 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) in face 104 of top shoe；Accordingly, convex surface 205 under 1 sliding block extends it is each provided with respectively in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) in face 204 of sliding block；That is: the lower convex surface 205 of sliding block extension stretches out to the described artificial disc after arthroplasty sagittal plane left and right sides and is embedded in two groove-like structure of top shoe extension upper recess surface 105 and can extend at top shoe and carries out a range of level of relative rotation in upper recess surface 105.
Described artificial disc after arthroplasty meet one of following requirement or its certain combination:
Top shoe 1 and sliding block 2 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤12 °；That is between top shoe 1 and the sliding block 2 of described artificial disc prosthese, relative rotation angle scope around its axis is≤12 °, wherein: for rotary moveable scope≤12 ° of the artificial disc after arthroplasty of cervical vertebra, for rotary moveable scope≤6 ° of the artificial disc after arthroplasty of lumbar vertebra；
Angle α≤30 ° of described artificial disc after arthroplasty top shoe sliding part edge surface 106 on sagittal plane and sliding block sliding part edge surface 206, that is the maximum angle range of activity realizing flexion-extension motion on sagittal plane is 30 °；Wherein: for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 30 °, for the flexion-extension motion scope of the artificial disc after arthroplasty of lumbar vertebra up to 24 °；
Angle of release α≤20 ° of described artificial disc after arthroplasty top shoe sliding part edge surface 106 on coronalplane and sliding block sliding part edge surface 206, that is to realize the angular range that on coronalplane, lateral bending range of activity is maximum be 20 °, wherein: for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 20 °, for the flexion-extension motion scope of the artificial disc after arthroplasty of lumbar vertebra up to 12 °.
Top shoe sliding part 102 and top shoe soleplate part 103 meet one of following requirement: one, and the two is able to the Split type structure part fitted together, and for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Sliding block sliding part 202 and sliding block soleplate part 203 meet one of following requirement: one, and the two is able to the Split type structure part fitted together, and for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Top shoe sliding part 102, sliding block sliding part 202 material be polyether-ether-ketone resin (PEEK) or high purity carbon fiberreinforced polyether-ether-ketone resin material (CFR-PEEK)；Top shoe soleplate part 103, sliding block soleplate part 203 the titanium alloy Ti-Nb-Zr-Sn that material is low elastic modulus.
Top shoe is slidably matched face 104 and sliding block is slidably matched face 204 supports or opposes from prosthese center on sagittal plane side shifting 2 8mm；
Described artificial disc after arthroplasty is additionally provided with saturating X-ray or can the labelling of X-ray thoroughly；Labelling is so that in operation process and postoperative inspection and adjustment；
Contact surface for the top shoe soleplate part 103 contacted with each other with adjacent vertebral bodies or sliding block soleplate part 203 uses plasma spraying method or other method to carry out hydroxyapatite material (HA) coating and prepare；
Described top shoe fixes device 107, the fixing device 207 of sliding block is specially following several one or a combination set of: the outside bur structure of wedge angle, prominent spine, diagonal screw duct；The concrete structure of described " prominent spine " meets following requirement: offering groove on adjacent vertebral body sclerotin, the correspondence position at the artificial disc after arthroplasty that contact corresponding to this groove arranges the fin installed with slot fit；
Following position requires to carry out the radiused process of rounding: top shoe is slidably matched face 104 and top shoe extends upper recess surface 105 junction, the top shoe being directly connected to or connected by transition face extends the corner of the attachment structure 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, is directly connected to or the sliding block that connected by transition face extends the corner of attachment structure between convex surface 205 and sliding block sliding part edge surface 206 down；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 transverse diameter and the ratio of sagittal diameter are 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, it is possible to rebuild the physiological camber of cervical vertebra and lumbar vertebra.
Equations of The Second Kind is three-member type (whole artificial disc after arthroplasty is mainly made up of three structural members), it specifically forms with top shoe 1, sliding block 2, intermediate slider 3 these three functional part, and intermediate slider 3 is arranged between the above two and its cooperation that contacts with each other with the former two respectively constitutes sliding area；Top shoe 1 and sliding block 2 are additionally provided with and fix the fixing device connected 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 is constituted by top shoe sliding part 102 and top shoe soleplate part 103, wherein: top shoe sliding part 102 is provided with for coordinating the sliding area and top shoe sliding area 101 contacted with intermediate slider 3 away from the centre of top shoe soleplate part 103 side；Top shoe sliding area 101 is slidably matched by the top shoe at centrally located place face 104 and be arranged on the be slidably matched top shoe of both sides, face 104 of top shoe and extend upper recess surface 105 and constitute；For coordinate with sliding block 2 constitute bend and stretch/the top shoe sliding part edge surface 106 of lateral bending position limiting structure is arranged in the top shoe sliding part 102 periphery away from the top shoe sliding area 101 of side, top shoe soleplate part 103 side；
Top shoe soleplate part 103 is provided with on the side away from top shoe sliding part 102 side for fixing the fixing device 107 of the top shoe connected with adjacent vertebral body；
2. sliding block 2 main part is connected to one is constituted by sliding block sliding part 202 and sliding block soleplate part 203, wherein: sliding block sliding part 202 is provided with for coordinating the sliding area and sliding block sliding area 201 contacted with intermediate slider 3 away from the centre of sliding block soleplate part 203 side；Sliding block sliding area 201 is slidably matched by the sliding block at centrally located place face 204 and be arranged on the be slidably matched sliding block of both sides, face 204 of sliding block and extend concave surface 205 and constitute；For coordinating the sliding block sliding part edge surface 206 constituting position limiting structure to be arranged in the sliding block sliding part 202 periphery away from the sliding block sliding area 201 of side, sliding block soleplate part 203 side with top shoe 1；
Sliding block soleplate part 203 is provided with on the side away from sliding block sliding part 202 side for fixing the fixing device 207 of the sliding block connected with adjacent vertebral body；
3. the upper and lower surface of intermediate slider 3 is provided with the face 104 that is slidably matched respectively with top shoe, sliding block is slidably matched the face that is slidably matched that face 204 contacts: the upper mating surface 303 of intermediate slider slip, the lower mating surface 304 of intermediate slider slip；On intermediate slider slides mating surface 303 and intermediate slider slide under the both sides of mating surface 304 be respectively arranged with extend upper recess surface 105 with top shoe respectively, 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 slide over the periphery in region 301 and intermediate slider slip underneath region 302 be also respectively provided with respectively the intermediate slider top edge face 307 of layout corresponding to top shoe sliding part edge surface 106, sliding block sliding part edge surface 206, intermediate slider lower limb face 308；
4. top shoe the slide face that contacts with each other of upper both mating surfaces 303 of face 104 and intermediate slider that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, another one Internal periphery face；Sliding block the slide face that contacts with each other of lower both mating surfaces 304 of face 204 and intermediate slider 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 Internal periphery face；
5. top shoe 1 and intermediate slider 3 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤9 °, sliding block 2 and intermediate slider 3 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤9 °, and namely top shoe 1 and sliding block 2 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤18 °；
6. in the lateral surface centre away from the top shoe soleplate part 103 of top shoe 1 and sliding block 2 contact surface side and sliding block soleplate part 203, it is respectively arranged with and coordinates top shoe arcuate surface 108, the sliding block arcuate surface 208 contacted with adjacent vertebral body.
Described artificial disc after arthroplasty meet one of following requirement or its certain combination:
The concrete structure limiting the two relative rotation angle scope on top shoe 1 and sliding block 2 in the horizontal direction being perpendicular to its main matching surface center meets following requirement:
It is each provided with 1 top shoe respectively extends upper recess surface 105 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) in face 104 of top shoe；It is each provided with 1 sliding block respectively extends concave surface 205 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) in 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 extend upper recess surface 105 with top shoe respectively, 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 extends lower convex surface 306 and stretches out to the described artificial disc after arthroplasty sagittal plane left and right sides respectively and be respectively embedded in that top shoe extends upper recess surface 105, sliding block extends in the groove-like structure of concave surface 205 and can carry out a range of level of relative rotation wherein.
In described artificial disc prosthese, top shoe 1 and sliding block 2 constitute fit structure by means of intermediate slider 3, wherein: top shoe 1 relative to sliding block 2 in the horizontal direction being perpendicular to its main matching surface center therebetween relative rotation angle area requirement be≤12 °；Wherein: for rotary moveable scope≤12 ° of the artificial disc after arthroplasty of cervical vertebra, for rotary moveable scope≤6 ° of the artificial disc after arthroplasty of lumbar vertebra；
Described artificial disc after arthroplasty top shoe sliding part edge surface 106 on sagittal plane, both sliding block sliding part edge surfaces 206 angle α≤15 ° respectively and between intermediate slider top edge face 307, intermediate slider lower limb face 308, realizing the full range of movement of flexion-extension motion on sagittal plane is 30 °, wherein for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 30 °, for the flexion-extension motion scope of artificial disc after arthroplasty of lumbar vertebra up to 24 °；
Described artificial disc after arthroplasty top shoe sliding part edge surface 106 on coronalplane, between sliding block sliding part edge surface 206 and intermediate slider top edge face 307, lower limb face 308 angle of release α≤10 °, realize the range of activity of maximum 20 ° of lateral bending on coronalplane, wherein for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 20 °, for the flexion-extension motion scope of artificial disc after arthroplasty of lumbar vertebra up to 12 °.
Top shoe sliding part 102 and top shoe soleplate part 103 meet one of following requirement: one, and the two is able to the Split type structure part fitted together, and for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Sliding block sliding part 202 and sliding block soleplate part 203 meet one of following requirement: one, and the two is able to the Split type structure part fitted together, and for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
The outer edge away from artificial disc after arthroplasty center of intermediate slider 3 is provided with and prevents from slipping structure 309, for the edge barrier structure longitudinally widened to unilateral or bilateral；
Top shoe sliding part 102, sliding block sliding part 202, intermediate slider 3 material be polyether-ether-ketone resin (PEEK) or high purity carbon fiberreinforced polyether-ether-ketone resin material (CFR-PEEK)；Top shoe soleplate part 103, sliding block soleplate part 203 low elastic modulus titanium alloy Ti-Nb-Zr-Sn.
Described artificial disc after arthroplasty meet one of following requirement or its certain combination:
Top shoe be slidably matched face 204, the intermediate slider of face 104, sliding block that be slidably matched slides upper mating surface 303 and the intermediate slider lower mating surface 304 that slides is supported or opposed from prosthese center side shifting 2 8mm on sagittal plane；
Angle of release α≤15 ° between top shoe sliding part edge surface 106 and intermediate slider top edge face 307, angle of release α≤15 ° between sliding block sliding part edge surface 206 and intermediate slider lower limb face 308；Distance between top shoe edge surface 106, sliding block edge surface 206 and intermediate slider edge surface is corresponding with angle of release α, jointly by the flexion angles Bit andits control in the direction 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 not easily quantitative description herein, it is relevant with the diameter in a certain direction of whole artificial disc, with to reach to bend and stretch angle also relevant；
Described artificial disc after arthroplasty is additionally provided with saturating X-ray or can the labelling of X-ray thoroughly；Labelling is so that in operation process and postoperative inspection and adjustment；
Contact surface plasma spraying method or other method for the top shoe soleplate part 103 contacted with each other with adjacent vertebral bodies or sliding block soleplate part 203 carry out hydroxyapatite material (HA) coating and process；
Device 107 that described top shoe is fixing with contiguous terminal plate of vertebral body and/or the sliding block device 207 fixing with contiguous terminal plate of vertebral body are specially following several one or a combination set of: the outside bur structure of wedge angle, dash forward spine, diagonal screw duct；The concrete structure of described " prominent spine " meets following requirement: offering groove on adjacent vertebral body sclerotin, the correspondence position at the artificial disc after arthroplasty that contact corresponding to this groove arranges the fin installed with slot fit；
Following position requires to carry out the radiused process of rounding: top shoe is slidably matched face 104 and top shoe extends upper recess surface 105 junction, the top shoe being directly connected to or connected by transition face extends the corner of the attachment structure 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, is directly connected to or the corner of attachment structure between the sliding block extension concave surface 205 and the sliding block sliding part edge surface 206 that are connected by transition face；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 above 303 and intermediate slider extend upper convex surface 305 junction, be directly connected to or the intermediate slider that connected by transition face extended and goes up that between convex surface 305 and intermediate slider top edge face 307 corner of attachment structure；Intermediate slider be slidably matched following 304 and intermediate slider extend lower convex surface 306 junction, be directly connected to or the intermediate slider that connected by transition face extend down that between convex surface 306 and intermediate slider lower limb face 308 corner of attachment structure；
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 transverse diameter and the ratio of sagittal diameter are 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, it is possible to rebuild the physiological camber of cervical vertebra and lumbar vertebra.
The present invention applies the term describing human body three-dimensional direction for human vertebra in human anatomy, is now enumerated explanation as follows:
" sagittal plane " or " sagittal plain " refers to be divided into by object on fore-and-aft direction the longitudinal section of two, left and right, " coronalplane " or " Coronal " refers to be divided into by object on left and right directions the longitudinal section of two, front and back, " horizontal plane " refers to vertical with sagittal plane and coronalplane, and object is divided into the plane of upper and lower two." sagittal diameter " refers to object front and back end horizontal range on sagittal plane, and " transverse diameter " refers to object left and right end horizontal range on coronalplane, and " highly " refers to object upper and lower side vertical dimension on sagittal plane.
" the cooperating " of the mating surface mentioned in the present invention refers to that the radius of curvature of male and female face is consistent, contact completely, the convex surface of soleplate part and terminal plate of vertebral body " adapting " refer to the convex surface shape along the depression of terminal plate of vertebral body of soleplate part, to reach as far as possible big contact surface.
According to the design principle of artificial disc after arthroplasty, prosthese should reach the requirement of three aspects, including rational motion, the lasting stability of performance be firmly fixed.The present invention is designed from these three aspect, and the feature for spinal column different parts makes adaptive scheme, better to realize the functional design expection of artificial disc after arthroplasty displacement.
In the big class artificial disc after arthroplasty of two the present invention relates to, the first artificial disc after arthroplasty being not provided with intermediate slider 3 is applicable to the artificial disc after arthroplasty displacement of cervical vertebra and lumbar vertebra, through the adaptability design of this kind of prosthese can be applicable to the small space of cervical vertebral space.Owing to the center of rotation of this kind of prosthese is fixed, along with forward and backward and side movement time (bending and stretching and lateral bending) when making it rotate in front and back and side, more conform to the feature of spinal segments motion, and this kind of prosthese has good stability, therefore also the type prosthetic replacement is also applied for the activity of lumbar vertebra and the requirement of carrying.
And the center of rotation being provided with the second artificial disc after arthroplasty of intermediate slider 3 is not fixed, mainly produce to rotate (include bending and stretching, lateral bending and axial-rotation) motion after this Using prosthesis, and side is moved inconspicuous, the Using prosthesis of cervical vertebra and lumbar vertebra can be applicable to through adaptability design.
Two kinds of artificial disc after arthroplasties that the present invention comprises are respectively provided with sliding area, the first artificial disc after arthroplasty being not provided with intermediate slider 3 has the contact surface that is slidably matched that one group of sliding area that is one group is corresponding, and the second artificial disc after arthroplasty being provided with intermediate slider 3 has the contact surface that is slidably matched that two sliding areas that is two groups are corresponding.
The design of sliding area is the key realizing 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 radius of curvature of male and female face, but the accuracy of manufacture requires significantly high, coordinate installation accuracy high, the requirement of working service is higher use also) or concave surface slightly larger (for the previous case identical relative to radius of curvature, the corresponding requirement suitably reducing its manufacture, installation, working service of the slightly larger energy of concave surface), curved surface is closely contacted with each other, upper in any direction can slide, and remain maximum contact area.The middle spheroid curvature portion of sliding area is to realize prosthese respectively to the basis of motion, and bigger contact surface advantageously reduces abrasion and strengthens its bearing capacity.The both sides of sliding area extend to composite surface region, 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 more than convex surface, certain distance is had between concave and convex surface, the part extending curved surface when prosthese rotates motion contacts and the motion that stops in the direction, plays the effect controlling to rotate.The design that this middle sphere slidably controls to rotate in conjunction with side curved surface is the unique advantage of the present invention, and this prosthese being beneficial to the present invention realizes the lasting stability motor function of controllable precise.The radius of curvature of the middle spheroid curved surface of sliding area and height are needed to reach movement effects and disc height decision by spinal segments design, and the radius of curvature difference of the composite surface that sliding area both sides extend determines spinal segments and designs the anglec of rotation that can reach.
The edge of sliding area, to extending around as edge opposite face, has certain outer angle of release and a distance between opposite face, and outer angle of release and distance different in all directions, this determines by needing the range of activity reached in the direction.Cervical vertebra flexion-extension motion on sagittal plane is generally within the scope of 30 °, and this is accomplished by the outer angle of release of front and back edge surface of artificial disc after arthroplasty up to 30 °, the displacement of sagittal plane radius of turn process when the distance of edge surface is reach outer angle of release angle.Lumbar vertebra flexion-extension motion on sagittal plane is generally within the scope of 24 °, and this is accomplished by the outer angle of release of front and back edge surface of artificial disc after arthroplasty up to 24 °, the displacement of sagittal plane radius of turn process when the distance of edge surface is reach outer angle of release angle.Cervical vertebra lateral bending on coronalplane is movable generally within the scope of 20 °, and this is accomplished by the outer angle of release in face, both sides of the edge of artificial disc after arthroplasty up to 20 °, the displacement of coronalplane radius of turn process when the distance of edge surface is reach outer angle of release angle.Lumbar vertebra lateral bending on coronalplane is movable generally within the scope of 12 °, and this is accomplished by the outer angle of release in face, both sides of the edge of artificial disc after arthroplasty up to 12 °, and the distance of edge surface is reach the displacement of the coronalplane radius of turn process required for outer angle of release angle.The outer angle of release of the edge surface on other vertical face between median sagittal plane and coronalplane and distance are seamlessly transitted by the outer angle of release in the above two planes and distance.Cervical vertebra rotary moveable scope in the horizontal plane is generally within the scope of 12 °, then the required distance of the male and female face that sliding area both sides extend meets the horizontal rotation angle reaching 12 ° of scopes.Lumbar vertebra rotary moveable scope in the horizontal plane is generally within the scope of 3 °, then the required distance of the male and female face that sliding area both sides extend meets the horizontal rotation angle reaching 3 ° of scopes.
Above-described sliding area and construction features about, be that the artificial disc after arthroplasty of the present invention realizes the rational architecture basics moved, the artificial disc after arthroplasty more current than this area realize the lasting movement effects of controllable precise more.
In order to enable artificial disc after arthroplasty to obtain the performance of lasting stability, artificial disc after arthroplasty of the present invention has carried out conscientiously carefully selecting in selection.For constituting the slide unit of sliding area, including the sliding part of 2-part formula prosthese and the sliding part of 3-part formula prosthese and intermediate slider, that the present invention selects is new special thermoplastic engineering plastic polyether-ether-ketone resin (Polyetheretherketone, or carbon fiber reinforced polyether-ether-ketone resin (CarbonFiberReinforcedPolyetheretherketone PEEK), CFR-PEEK), such material has lot of advantages: 1) low elastic modulus high intensity；2) extremely low abrasion, the wear rate of latter of which is lower 12 times than current artificial intervertebral disk commonly used material (polyethylene cobalt chromium)；3) good biocompatibility, stable performance, the not oxidated impact with ray；4) can X ray thoroughly, it is easy to labelling.It is the ideal material making slide unit that these material advantages determine polyether-ether-ketone resin, and it is capable of the sliding capability of long-term stability, and provides conveniently to imaging evaluation.Corresponding part entirety uses CFR-PEEK material, it is possible to reduce the volume of prosthese while providing outstanding wearability, 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 selects new titanium alloy material Ti-Nb-Zr-Sn.This new titanium alloy material is the material that Metal Inst., Chinese Academy of Sciences independently invents, and has a lot of excellent in performance: 1) low elastic modulus, high intensity；2) elastic deformation ability is strong；3) good biocompatibility, safety non-toxic；4) imaging evaluation is not affected.This titanium alloy low elastic modulus characteristic can make soleplate part more mate with terminal plate of vertebral body, it is to avoid contact surface heavily stressed；High intensity (its intensity is higher than common medical titanium alloy) is conducive to increasing the bearing capacity of prosthese.It is the ideal material making more than one piece body slide block soleplate parts that these material characteristicses determine new titanium alloy.
The slider part of the artificial disc after arthroplasty of present invention design can be mutually permanently connected by two or more but non-dismountable or dismountable part forms, for demountable structure, between corresponding sliding part and soleplate part, draw-in groove or screw method is utilized to be fixed as one.
The also important factor that realizes of the lasting stability function of artificial disc after arthroplasty is exactly firm fixing, and fixes including immediate postoperative and fixes with permanent.The present invention, in order to realize at once fixing of prosthesis endplate part and terminal plate of vertebral body, designs bur, prominent spine or diagonal screw duct as at once fixing device, it is possible to select fixing means according to practical situation on soleplate part.At once fixing is not final goal, is to realize fixing offer time and mechanical environment for a long time.The permanent fixing basis being only the real guarantee normal functionating of artificial disc after arthroplasty.
The prosthese of the present invention better realizes the permanent fixing of prosthese by the design of two aspects: 1) the soleplate part of prosthese is having a convex surface with design on the contact surface of 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 that soleplate part is maximum with terminal plate of vertebral body, so can reduce the stress of contact surface, it is prevented that prosthese depression enters in vertebral body sclerotin；2) contact surface of prosthesis endplate part Yu terminal plate of vertebral body being carried out hydroxyapatite coating layer process, this coating material can be embedded by vertebral body bone tissue growth, and namely prosthesis endplate part and vertebral body sclerotin are grown to one, finally realizes stable fixing for a long time.The present invention realizes effective at once fixing and permanent fixing by decision design described above, has advantage in the current artificial disc after arthroplasty in this area, and this is for reducing the depression of prosthese and loosening highly significant.
Present invention is alternatively directed to several details of design carried out preferably.In prosthese of the present invention, the edge of all structures or corner will carry out radiused process, it is prevented that unnecessary parts cutting damage.Due to the sliding part of prosthese of the present invention be can X-ray material thoroughly, therefore to be easy to imaging evaluation, sliding part is provided with the annulet of X-ray thoroughly.The artificial disc after arthroplasty of the present invention is installed in operation and by means of supporting installation apparatus, therefore to be designed hole clipping in the soleplate part both sides of prosthese or draw-in groove, this hole clipping or draw-in groove can be connected with installing apparatus, to guide the correct placement of prosthese.This design is also necessary when artificial disc after arthroplasty Minimally Invasive Surgery.
Owing to the rotating shaft of human spine's sections flexion and extension is not the center of intervertebral disc, but it is moved rearwards by certain distance, therefore the sliding area of the prosthese of present invention design has been moved rearwards by 2 8mm on sagittal plane, so can be closer to the flexion and extension feature of physiological status.Concrete rear shifting distance is adjusted because of the difference of spinal segments.
In the present invention, a special technical problem is had to need to solve for the artificial disc after arthroplasty being provided with intermediate slider 3: intermediate slider 3 exists the risk skidding off the sliding area coordinating contact.Once postoperative generation slide block comes off, it will the function of nervous system of patient is produced very big harm.For this risk, the present invention is at one extended structure of edge designs of intermediate slider, barrier structure 309 that namely edge of intermediate slider 3 is longitudinally widened to unilateral or bilateral.When described artificial disc after arthroplasty moves to the limit in certain direction, top shoe 1, sliding block 2 edge will press to the edge of intermediate slider, be stuck in barrier structure 309 place, thus preventing intermediate slider 3 from skidding off to offside.
Being all physiological lordosis owing to the spinal column of human body exists physiological bending, cervical vertebra and lumbar vertebra, namely intervertebral disc leading edge height is more than trailing edge height, therefore, the front and rear edge height of soleplate part of the artificial disc after arthroplasty of present invention design is inconsistent, and leading edge is more than trailing edge, and namely on sagittal plane, 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 present invention design is determined according to the form of patient pathological changes vertebral body, can being circular, oval, semicircle or trapezoidal, its sagittal diameter be 8 50mm, and transverse diameter is 10 60mm, being highly 5 30mm, the ratio of transverse diameter and sagittal diameter is 4:3 or 5:3 or 2:1.
Comprehensive, the artificial disc after arthroplasty of the present invention has the special construction selecting to apply and realization is fixing for a long time of the sliding area structural design of uniqueness, new material, and these features make the prosthese that the present invention designs have obvious advantage and innovation in the art.By the research of the aspect such as biocompatibility and biomechanics to artificial lumbar disc device, after reaching corresponding standard, it is applied to clinical treatment cervical vertebra and Lumbar intervertebral disc Cataplasia disease.Artificial disc after arthroplasty of the present invention is while removing pathological interspinal dish, accurately remain physiological movement and the loading functionality of operated level, keep stability and the activeness of spinal column, avoiding neighbouring section stress and increase caused intervertebral disc acceleration regression, these performance advantages make it have fabulous application prospect in the art.
Accompanying drawing explanation
Fig. 1 is the coronalplane schematic diagram of the first artificial disc after arthroplasty being not provided with intermediate slider 3；
Fig. 2 is the central sagittal plane schematic diagram of the first artificial disc after arthroplasty being not provided with intermediate slider 3；
Fig. 3 is the horizontal plane schematic diagram of the first artificial disc after arthroplasty being not provided with intermediate slider 3；
Fig. 4 is the coronalplane schematic diagram of the second artificial disc after arthroplasty being provided with intermediate slider 3；
Fig. 5 is the central sagittal plane schematic diagram of the second artificial disc after arthroplasty being provided with intermediate slider 3；
Fig. 6 is the horizontal plane schematic diagram of the second artificial disc after arthroplasty being provided with intermediate slider 3；
Fig. 7 is one of artificial disc after arthroplasty bulk shape schematic diagram；
Fig. 8 is the two of artificial disc after arthroplasty bulk shape schematic diagram；
Fig. 9 is the three of artificial disc after arthroplasty bulk shape schematic diagram；
Figure 10 is the four of artificial disc after arthroplasty bulk shape schematic diagram；
Figure 11 is the 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 the two of artificial disc after arthroplasty soleplate part fixed form schematic diagram；
Figure 14 is the three of artificial disc after arthroplasty soleplate part fixed form schematic diagram；
Figure 15 is the four of artificial disc after arthroplasty soleplate part fixed form schematic diagram；
Figure 16 is the five of artificial disc after arthroplasty soleplate part fixed form schematic diagram；
Figure 17 is the six of artificial disc after arthroplasty soleplate part fixed form schematic diagram；
Figure 18 is the seven of artificial disc after arthroplasty soleplate part fixed form schematic diagram；
Figure 19 is the eight of artificial disc after arthroplasty soleplate part fixed form schematic diagram.
Detailed description of the invention
In order to more vividly describe the artificial disc after arthroplasty of the present invention, it is specifically described below by way of legend:
Fig. 1 is the coronalplane schematic diagram of the first artificial disc after arthroplasty (2 formula artificial disc after arthroplasties) being not provided with 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 by corresponding sliding part and soleplate part and utilize certain mode to be fixed as one respectively.The sliding area contacted with each other is had, including the sliding block sliding area 201 of the top shoe sliding area 101 of top shoe sliding part 102 and sliding block sliding part 202 between top shoe 1 and sliding block 2.Each sliding area mid portion is that the top shoe of the spheroid curved surface that radius of curvature is identical is slidably matched face 104 and sliding block is slidably matched face 204, both sides extend to cylinder (or Rotary-table) and sphere (or arc surface) combines male and female face: top shoe extends upper recess surface 105 and sliding block extends lower convex surface 205, and the top shoe matched extends the radius of curvature of upper recess surface 105 and extends lower convex surface 205 more than sliding block.The edge of top shoe sliding area 101 and sliding block sliding area 201 includes top shoe sliding part edge surface 106 and sliding block sliding part edge surface 206, above and have certain distance and angle of release α between below.Sliding area extends composite surface part and matches with edge surface partial distance and angle of release α, jointly realizes the controlling motion on lateral bending direction.The fixing device 107 of top shoe and the fixing device 207 of sliding block it is provided with, in order to reach stablizing effect at once between top shoe 1 and sliding block 2 and adjacent vertebral bodies.Top shoe soleplate part 103 and sliding block soleplate part 203 have top shoe arcuate surface 108 and the sliding block arcuate surface 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 implants depression, improve implants-bone bonding strength, it is achieved implants is steady in a long-term.
Fig. 2 is the central sagittal plane schematic diagram of the first artificial disc after arthroplasty (2 formula artificial disc after arthroplasties) being not provided with intermediate slider 3；Shown in Fig. 2, owing to the artificial disc after arthroplasty sliding area of the present invention extends to lateral symmetry, therefore central authorities sagittal plane on slip region list be now simple socket joint arrangement, the sliding block that namely top shoe on top shoe 1 is slidably matched on face 104 and sliding block 2 be slidably matched face 204 coordinate composition joint.Motion on sagittal plane is controlled by the distance between top shoe sliding part edge surface 106 and the sliding block sliding part edge surface 206 of sliding area front and back and angle of release α, to realize accurate flexion and extension.Due to cervical vertebra and lumbar motion segment bend and stretch in the minds of rotation relative after move, top shoe sliding area 101 and the sliding block sliding area 201 of artificial disc after arthroplasty of the present invention are moved rearwards by certain distance on sagittal plane, better to realize physiological flexion and extension.Owing to cervical vertebra and lumbar vertebra exist physiological lordosis, therefore the top shoe soleplate part 103 of artificial disc after arthroplasty of the present invention and sliding block soleplate part 203 front height are more than rear portion, and the physiological to rebuild cervical vertebra and lumbar vertebra bends.
Fig. 3 is the horizontal plane schematic diagram of the first artificial disc after arthroplasty (2 formula artificial disc after arthroplasties) being not provided with intermediate slider 3；Shown in Fig. 3, artificial disc after arthroplasty shows that on the horizontal plane of sliding area it realizes the construction features that controlling rotates more intuitively.Sliding area intermediate face portion and top shoe are slidably matched face 104 and sliding block is slidably matched, and face 204 provides enough contact interfaces for rotary motion, in conjunction with the excellent in performance of CFR-PEEK material selected by sliding part, has fully ensured that the smooth-going of rotary motion 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 key realizing Spin Control.Owing to top shoe extends upper recess surface 105 Rotary-table curvature portion convex surface 205 cylinder curvature portion under sagittal radius of curvature extends more than sliding block, and have certain distance and angle between top shoe extension upper recess surface 105 and the lower convex surface 205 of sliding block extension, when reaching this distance and angle when rotary motion, upper recess surface contacts with lower convex surface, thus realizing the control of rotary motion.
Fig. 4 is the coronalplane schematic diagram of the second artificial disc after arthroplasty being provided with 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, top shoe 1 and sliding block 2 and forms by sliding part and soleplate part, and the latter two utilize certain mode to be fixed as one.The sliding area contacted with each other is had, including the convex surface 301 and 302 in the depression hole 101 and 201 of top shoe and sliding block, intermediate slider between top shoe 1 and sliding block 2 and intermediate slider 3.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) combines male and fomale(M&F) 105,205,305 and 306, corresponding top shoe and sliding block and extends the radius of curvature of concave surface 105 and 205 (Rotary-table curvature portion) more than the upper convex surface 305 of intermediate slider extension and the lower convex surface 306 (cylinder curvature portion) of extension.The edge of sliding area 101,201,301 and 302 includes outside edge 106 and 206, and edge inner face 307 and 308, has certain distance and angle of release α between inner face and outside.Sliding area extends composite surface part and matches with edge surface partial distance and angle of release α, jointly realizes the controlling motion on lateral bending direction.For 3-part formula prosthese, owing to intermediate slider exists the risk skidded off, the present invention is at the longitudinal barrier structure 309 widened of edge designs of intermediate slider, and this structure is prevented from intermediate slider and slips to motion rightabout.There is fixing device 107 and 207, in order to reach stablizing effect at once between top shoe 1 and sliding block 2 and adjacent vertebral bodies.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 implants depression, improve implants-bone bonding strength, it is achieved implants is steady in a long-term.
Fig. 5 is the central sagittal plane schematic diagram of the second artificial disc after arthroplasty being provided with intermediate slider 3；Shown in Fig. 5, owing to the artificial disc after arthroplasty sliding area of the present invention extends to lateral symmetry, therefore on central authorities' sagittal plane, slip region list be now double; two socket joint arrangement, and namely the depression of top shoe 1 and sliding block 2 cheats 104 and 204 and convex surface 303 and 304 associated section of intermediate slider.Motion on sagittal plane is controlled by the distance between the edge surface 106,206,307 and 308 of sliding area front and back and angle of release α, to realize accurate flexion and extension.Due to cervical vertebra and lumbar motion segment bend and stretch in the minds of rotation relative after move, the sliding area 101,201,301 and 302 of artificial disc after arthroplasty of the present invention is moved rearwards by certain distance on sagittal plane, better to realize physiological flexion and extension.Owing to cervical vertebra and lumbar vertebra exist physiological lordosis, therefore soleplate part 103 and 203 front height of artificial disc after arthroplasty of the present invention is more than rear portion, and the physiological to rebuild cervical vertebra and lumbar vertebra bends.
Fig. 6 is the horizontal plane schematic diagram of the second artificial disc after arthroplasty being provided with intermediate slider 3；Shown in Fig. 6, artificial disc after arthroplasty shows that on the horizontal plane of sliding area it realizes the construction features that controlling rotates more intuitively.Sliding area intermediate face portion 104,204,303 and 304 provides enough contact interfaces for rotary motion, in conjunction with the excellent in performance of CFR-PEEK material selected by sliding part and intermediate slider, has fully ensured that the smooth-going of rotary motion carries out.And the extension 105,205,305 and 306 of sliding area both sides is the key realizing Spin Control.Due to upper recess surface 105 and concave surface 205 Rotary-table curvature portion convex surface 305 and convex surface 306 cylinder curvature portion under extension on sagittal radius of curvature extends more than intermediate slider, certain distance and angle is had between upper concave surface 105 and 205 and the upper convex surface 305 of middle extension and the lower convex surface 306 of extension, when reaching this distance and angle when rotary motion, upper recess surface contacts with lower convex surface, thus realizing the control of rotary motion.
Fig. 7-Figure 11 is artificial disc after arthroplasty bulk shape schematic diagram；Multiple entirety (soleplate part) the external form schematic diagram of present invention design, including ellipse (Fig. 7, Fig. 8), semicircle (Fig. 9), trapezoidal (Figure 10), apple shape (Figure 11).Owing to cervical vertebra and lumbar vertebra exist physiological lordosis, its spinal column longitudinal stress axle moves relative to vertebral body center back, therefore the present invention has carried out adaptability design, including moving certain distance after sliding area, and relatively increases soleplate part 103 and 203 rear width.These are conducive to carrying better axial load, rationally increase soleplate part 103 and 203 and the contact surface of adjacent vertebral bodies soleplate, it is prevented that implants depression.Above-mentioned several soleplate part external form embodies 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, realized by certain structure and be close to fixing at once of vertebral body), soleplate part 103 and 203 designs bur (Figure 14, Figure 15), diagonal screw duct (Figure 16, Figure 17) or prominent spine (Figure 18, Figure 19) as at once fixing device, it is possible to select fixing means according to practical situation.
For the careful design scheme of more specifically bright artificial disc after arthroplasty of the present invention, existing structure and exercise data according to cervical vertebra and lumbar vertebra carries out specific embodiment description:
Embodiment 1 one kinds is for substituting the artificial disc after arthroplasty of cervical vertebra completely, and background relates to neck 4-5 intervertebral disc degeneration and a dysfunction, need to carry out the cervical disc replacement surgery of this sections, and the adjacent discs 26S Proteasome Structure and Function of patient is normal.Need before prosthetic designs patient is carried out a series of imaging examination, including: the c spine ap & lat DR of neutral position, cervical vertebra bend and stretch position, side 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 data below: the anteflexion range of activity (ROM) of neck 3-4 intervertebral disc is αFlx, after to stretch ROM be αEx, lateral bending ROM be αLatIf (left and right lateral bending is inconsistent, then average), rotation ROM are αRoThe center of rotation distance L from intervertebral disc sagittal diameter midpoint when (if left rotation and right rotation is inconsistent, then average), flexion and extensionr3-4, neck 3-4 intervertebral disc neutral position time leading edge height Ha3-4, and trailing edge height Hp3-4；The anteflexion range of activity (ROM) of neck 5-6 intervertebral disc is γFlx, after to stretch ROM be γEx, lateral bending ROM be γLatIf (left and right lateral bending is inconsistent, then average), rotation ROM are γRoThe center of rotation distance L from intervertebral disc sagittal diameter midpoint when (if left rotation and right rotation is inconsistent, then average), flexion and extensionr5-6, neck 5-6 intervertebral disc neutral position time leading edge height Ha5-6, and trailing edge height Hp5-6；The sagittal diameter L of pathological interspinal dish neck 4-5ap4-5, transverse diameter Llr4-5, and the three-dimensional configuration (including the depression form of the shape of horizontal plane, sagittal plane and coronalplane) of contiguous terminal plate of vertebral body.
According to above measured iconography data, carry out the design of artificial disc after arthroplasty used by the neck 4-5 intervertebral disc replacement of this patient's pathological changes, select including overall structure, the structural design of the structural design of sliding area and soleplate part.Over or under in order to avoid moving, the neck 4-5 intervertebral disc of pathological changes to reach kinestate and take the intermediate value of upper and lower two adjacent discs exercise datas.
Generally in the process of bending and stretching, the motion of vertebral body sections is to rotate to be master for cervical vertebra, and adjoint vertebral body moves forward and backward inconspicuous, and now we select the prosthetic designs of 3-part formula structure.The profile of whole artificial cervical intervertebral disc prosthese is the semicircle similar to the shape of contiguous vertebral body horizontal section, ellipse or " D " font, its sagittal diameter Lap=Lap4-5-4 (mm), transverse diameter Llr=Llr4-5-5 (mm), height H=(Ha3-4+Hp3-4+Ha5-6+Hp5-6)/4。
According to the data measured, design the structure of sliding area:
1) the upper lower sphere convex radius of intermediate slider is identical, sets curved surface height HcFor the 1/4 of whole height, set the base radius r of curved surface as 2.5 times of curved surface height, then have: Hc=H/4, r=Hc×2.5
Then the radius of curvature R of spheroid curved surface is: R=(r2+Hc 2)/2Hc
The curved angle Α of spheroid convex surface is: Α=2Sin-1(r/R)；
2) the spheroid concave surface of sliding area matches with intermediate slider convex surface, and namely the radius of curvature of male and female face is identical；
3) sliding area position on sagittal plane adjusts accordingly according to the center of rotation position measured, and namely sliding area center back moves a certain distance Lc, then have: Lc=(Lr3-4+Lr5-6)/2；
4) radius of curvature of the concave and convex surface that sliding area both sides extend, convex surface extends to cylinder, and its end is the sphere concentric with sliding area center of rotation, extends convex surface height HyIt is set as middle spheroid curved surface height Hc2/5, and set the coronalplane of convex surface as semicircle, i.e. the radius of curvature R of convex surfacey=Hy=2Hc/ 5, the width W that end extendsyFor 1/2nd of spheroid both sides of the edge face width degree, then have: Wy=(Llr/2-r)/2；
Upper recess surface is corresponding irregular Rotary-table curved surface, and certain sagittal plane upper recess surface summit is to distance a and the required lateral bending angle [alpha] reached on corresponding convex surface summitLatWith the distance L that this sagittal plane distance prosthese horizontally rotates centerhRelevant, then have:
A=Sin (αLat/4)×Lh×2
The radius of curvature R of upper recess surfacesWith translation distance L when rotating before and after the upper recess surface summit distance a to convex surface summit and upper recess surfacerRelevant, then have: Lr=Sin (αFlx/4)(R-Hc+Hy)×2,Rs=a+r+ (Lr-a2)/2a,
The end of upper recess surface is the arc surface matched on coronalplane with lower convex surface end.
The Spin Control angle being capable of by design above is αr, then have:
αr=4Sin-1Lr/{2×[r-Sin(αLat/4)×R/Cos(A/2-αLat/4)]}；
5) the angle of release α and distance L of sliding area edge surface, wherein the distance of distance L prosthese spheroid male and female face outer rim represents, with sliding area front edge face (αaAnd La) be calculated as example, then have: αa=(αFlx+γFlx)/4,
La=R × Sin (αa/2)×2
Angle of release and the distance at sliding area both sides and rear in like manner calculate, and the edge surface angle of release in other eccentric occlusion direction and distance seamlessly transit based on aforementioned 4 directions.
There is two sliding surfaces and corresponding edge opposite face due to 3-part formula prosthese, therefore to reach the bending amplitude of designing requirement, the edge surface of its intermediate slider above and below only need to each control the motion amplitude of half.
The structure of soleplate part is designed according to measurement data:
1) the height H of soleplate part above or belowendIt is set as the 1/6 of whole prosthese height H, i.e. Hend=H/6.Owing to cervical vertebra exists physiological lordosis, its leading edge height is more than trailing edge, and therefore soleplate part is generally trapezoidal on median sagittal plane, leading edge height Hend-aMore than trailing edge height Hend-p, then have:
Hend-a=Hend+[(Ha3-4+Ha5-6)-(Hp3-4+Hp5-6)]/8
Hend-p=Hend-[(Ha3-4+Ha5-6)-(Hp3-4+Hp5-6)]/8；
2) soleplate part is designed according to cervical vertebra three dimensional CT result with the protruding form of the contact surface of terminal plate of vertebral body, including the protruding width at sagittal plane and coronalplane and height.
Through above calculating, complete the design of artificial cervical intervertebral disc prosthese, this prosthese can accurately attain the range of activity required by cervical vertebral segment and mode, and meet intervertebral disc space structure to be implanted and physiological camber, by the motion close fit with neighbouring section after Using prosthesis, realized motion and the bearing function of cervical vertebral segment steady in a long-term by the bone tissue growth of soleplate contact surface.
Embodiment 2 one kinds is for substituting the artificial disc after arthroplasty of lumbar vertebra completely, and background relates to a waist 4-5 intervertebral disc degeneration and dysfunction, it is necessary to carrying out the lumbar disc prosthesis operation of this sections, the adjacent discs 26S Proteasome Structure and Function of patient is normal.Need before prosthetic designs patient is carried out a series of imaging examination, including: the l spine ap & lat DR of neutral position, lumbar vertebra bend and stretch position, side power DR, lumbar lateral curvature normotopia power DR, lumbar vertebra rotation normotopia power DR, lumbar vertebra three dimensional CT.
By the measurement to imaging data, obtain data below: the anteflexion range of activity (ROM) of waist 3-4 intervertebral disc is αFlx, after to stretch ROM be αEx, lateral bending ROM be αLatIf (left and right lateral bending is inconsistent, then average), rotation ROM are αRoThe center of rotation distance L from intervertebral disc sagittal diameter midpoint when (if left rotation and right rotation is inconsistent, then average), flexion and extensionr3-4, waist 3-4 intervertebral disc neutral position time leading edge height Ha3-4, and trailing edge height Hp3-4；The anteflexion range of activity (ROM) of waist 5-sacrum 1 intervertebral disc is γFlx, after to stretch ROM be γEx, lateral bending ROM be γLatIf (left and right lateral bending is inconsistent, then average), rotation ROM are γRoThe center of rotation distance L from intervertebral disc sagittal diameter midpoint when (if left rotation and right rotation is inconsistent, then average), flexion and extensionr5-1, waist 5-sacrum 1 intervertebral disc neutral position time leading edge height Ha5-1, and trailing edge height Hp5-1；The sagittal diameter L of pathological interspinal dish waist 4-5ap4-5, transverse diameter Llr4-5, and the three-dimensional configuration (including the depression form of the shape of horizontal plane, sagittal plane and coronalplane) of contiguous terminal plate of vertebral body.
According to above measured iconography data, carry out the design of artificial disc after arthroplasty used by the waist 4-5 intervertebral disc replacement of this patient's pathological changes, select including overall structure, the structural design of the structural design of sliding area and soleplate part.Over or under in order to avoid moving, the waist 4-5 intervertebral disc of pathological changes to reach kinestate and take the intermediate value of upper and lower two adjacent discs exercise datas.
Lumbar vertebra generally in the process of bending and stretching the reach of vertebral body and rear shifting more apparent, namely the motion of lumbar motion segment rotates along with vertebral body transverse shifting, and lumbar vertebra has important carrying effect, and now we select the prosthetic designs of 2-part formula structure.The profile of whole lumbar vertebra artificial disc after arthroplasty is the semicircle similar to the shape of contiguous vertebral body horizontal section, ellipse or " D " font, its sagittal diameter Lap=Lap4-5-6 (mm), transverse diameter Llr=Llr4-5-8 (mm), height H=(Ha3-4+Hp3-4+Ha5-6+Hp5-6)/4。
According to the data measured, design the structure of sliding area:
1) the upper lower sphere convex radius of intermediate slider is identical, sets curved surface height HcFor the 1/3 of whole height, set the base radius r of curved surface as 2 times of curved surface height, then have: Hc=H/3, r=Hc×2
Then the radius of curvature R of spheroid curved surface is: R=(r2+Hc 2)/2Hc
The curved 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 namely the radius of curvature of male and female face is identical；
3) sliding area position on sagittal plane adjusts accordingly according to the center of rotation position measured, and namely sliding area center back moves a certain distance Lc, then have: Lc=(Lr3-4+Lr5-6)/2；
4) radius of curvature of the concave and convex surface that sliding area both sides extend, convex surface extends to cylinder, and its end is the sphere concentric with sliding area center of rotation, extends convex surface height HyIt is set as middle spheroid curved surface height Hc2/5ths, and set the coronalplane of convex surface as semicircle, i.e. the radius of curvature R of convex surfacey=Hy=2Hc/ 5, the width W that end extendsyFor 1/2nd of spheroid both sides of the edge face width degree, then have: Wy=(Llr/2-r)/2；
Upper recess surface is corresponding irregular Rotary-table curved surface, and certain sagittal plane upper recess surface summit is to distance a and the required lateral bending angle [alpha] reached on corresponding convex surface summitLatWith the distance L that this sagittal plane distance prosthese horizontally rotates centerhRelevant, then have:
A=Sin (αLat/2)×Lh×2
The radius of curvature R of upper recess surfacesWith translation distance L when rotating before and after the upper recess surface summit distance a to convex surface summit and upper recess surfacerRelevant, then have: Lr=Sin (αFlx/2)(R-Hc+Hy)×2,Rs=a+r+ (Lr-a2)/2a,
The end of upper recess surface is the arc surface matched on coronalplane with lower convex surface end.
The Spin Control angle being capable of by design above is αr, then have:
αr=2Sin-1Lr/{2×[r-Sin(αLat/2)×R/Cos(A/2-αLat/2)]}；
5) the angle of release α and distance L of sliding area edge surface, wherein the distance of distance L prosthese spheroid concave surface outer rim represents, with sliding area front edge face (αaAnd La) be calculated as example, then have:
αa=(αFlx+γFlx)/2, La=R × Sin (αa/2)×2
Angle of release and the distance at sliding area both sides and rear in like manner calculate, and the edge surface angle of release in other eccentric occlusion direction and distance seamlessly transit based on aforementioned 4 directions.
The structure of soleplate part is designed according to measurement data:
1) the height H of soleplate part above or belowendIt is set as the 1/6 of whole prosthese height H, i.e. Hend=H/6.Owing to lumbar vertebra exists physiological lordosis, its leading edge height is more than trailing edge, and therefore soleplate part is generally trapezoidal on median sagittal plane, leading edge height Hend-aMore than trailing edge height Hend-p,
Hend-a=Hend+[(Ha3-4+Ha5-6)-(Hp3-4+Hp5-6)]/8
Hend-p=Hend-[(Ha3-4+Ha5-6)-(Hp3-4+Hp5-6)]/8；
2) soleplate part is designed according to lumbar vertebra three dimensional CT result with the protruding form of the contact surface of terminal plate of vertebral body, including the protruding width at sagittal plane and coronalplane and height.
Through above calculating, complete the design of lumbar vertebra artificial disc after arthroplasty, this prosthese can accurately attain the range of activity required by lumbar motion segment and mode, 2-part formula is easy to provide better bearing capacity, prosthese meets intervertebral disc space structure to be implanted and physiological camber, by the motion close fit with neighbouring section after Using prosthesis, realized 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 completely, it is specially two-piece (whole artificial disc after arthroplasty is mainly made up of) two structural members, it specifically forms with top shoe 1 and sliding block 2 the two functional part, is separately provided for coordinating therebetween the sliding area contacted on top shoe 1 with sliding block 2；Top shoe 1 and sliding block 2 are additionally provided with and fix the fixing device connected 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 is constituted by top shoe sliding part 102 and top shoe soleplate part 103, wherein: top shoe sliding part 102 is provided with for coordinating the sliding area and top shoe sliding area 101 contacted with sliding block 2 away from the centre of top shoe soleplate part 103 side；Top shoe sliding area 101 is slidably matched by the top shoe at centrally located place face 104 and be arranged on the be slidably matched top shoe of both sides, face 104 of top shoe and extend upper recess surface 105 and constitute；For coordinate with sliding block 2 constitute bend and stretch/the top shoe sliding part edge surface 106 of lateral bending position limiting structure is arranged in the top shoe sliding part 102 periphery away from the top shoe sliding area 101 of side, top shoe soleplate part 103 side；
Top shoe soleplate part 103 is provided with on the side away from top shoe sliding part 102 side for fixing the fixing device 107 of the top shoe connected with adjacent vertebral body；
2. sliding block 2 main part is connected to one is constituted by sliding block sliding part 202 and sliding block soleplate part 203, wherein: sliding block sliding part 202 is provided with for coordinating the sliding area and sliding block sliding area 201 contacted with top shoe 1 away from the centre of sliding block soleplate part 203 side；Sliding block sliding area 201 is slidably matched by the sliding block at centrally located place face 204 and be arranged on the be slidably matched sliding block of both sides, face 204 of sliding block and extend lower convex surface 205 and constitute；For coordinating the sliding block sliding part edge surface 206 constituting position limiting structure to be arranged in the sliding block sliding part 202 periphery away from the sliding block sliding area 201 of side, sliding block soleplate part 203 side with top shoe 1；
Sliding block soleplate part 203 is provided with on the side away from sliding block sliding part 202 side for fixing the fixing device 207 of the sliding block connected with adjacent vertebral body；
3. top shoe be slidably matched with the sliding block face that contacts with each other in both faces 204, face 104 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 Internal periphery face；
4. top shoe 1 and sliding block 2 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤18 °；
5. in the lateral surface centre away from the top shoe soleplate part 103 of top shoe 1 and sliding block 2 contact surface side and sliding block soleplate part 203, it is respectively arranged with and coordinates top shoe arcuate surface 108, the sliding block arcuate surface 208 contacted with adjacent vertebral body.
Described artificial disc after arthroplasty, also includes the description below and requires:
The concrete structure limiting the two relative rotation angle scope on top shoe 1 and sliding block 2 in the horizontal direction being perpendicular to its main matching surface center meets following requirement: be each provided with 1 top shoe respectively extend upper recess surface 105 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) in face 104 of top shoe；Accordingly, convex surface 205 under 1 sliding block extends it is each provided with respectively in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) in face 204 of sliding block；That is: under sliding block, convex surface 205 stretches out to the described artificial disc after arthroplasty sagittal plane left and right sides and is embedded into top shoe and extends in two groove-like structure of upper recess surface 105 and can extend at top shoe and carry out a range of level of relative rotation in upper recess surface 105.
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 in the horizontal direction being perpendicular to its main matching surface center is≤12 °；That is between top shoe 1 and the sliding block 2 of described artificial disc prosthese, relative rotation angle scope around its axis is≤12 °, wherein: for rotary moveable scope≤12 ° of the artificial disc after arthroplasty of cervical vertebra, for rotary moveable scope≤6 ° of the artificial disc after arthroplasty of lumbar vertebra；Angle α≤30 ° of described artificial disc after arthroplasty top shoe sliding part edge surface 106 on sagittal plane and sliding block sliding part edge surface 206, that is the maximum angle range of activity realizing flexion-extension motion on sagittal plane is 30 °；Wherein: for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 30 °, for the flexion-extension motion scope of the artificial disc after arthroplasty of lumbar vertebra up to 24 °；Angle of release α≤20 ° of described artificial disc after arthroplasty top shoe sliding part edge surface 106 on coronalplane and sliding block sliding part edge surface 206, that is to realize the angular range that on coronalplane, lateral bending range of activity is maximum be 20 °, wherein: for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 20 °, for the flexion-extension motion scope of the artificial disc after arthroplasty of lumbar vertebra up to 12 °.
Top shoe sliding part 102 and top shoe soleplate part 103 meet one of following requirement: one, and the two is able to the Split type structure part fitted together, and for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Sliding block sliding part 202 and sliding block soleplate part 203 meet one of following requirement: one, and the two is able to the Split type structure part fitted together, and for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Top shoe sliding part 102, sliding block sliding part 202 material be polyether-ether-ketone resin (PEEK) or high purity carbon fiberreinforced polyether-ether-ketone resin material (CFR-PEEK)；Top shoe soleplate part 103, sliding block soleplate part 203 the titanium alloy Ti-Nb-Zr-Sn that material is low elastic modulus.Top shoe is slidably matched face 104 and sliding block is slidably matched face 204 supports or opposes from prosthese center on sagittal plane side shifting 2 8mm；
Described artificial disc after arthroplasty is additionally provided with saturating X-ray or can the labelling of X-ray thoroughly；Labelling is so that in operation process and postoperative inspection and adjustment；Contact surface for the top shoe soleplate part 103 contacted with each other with adjacent vertebral bodies or sliding block soleplate part 203 uses plasma spraying method or other method to carry out hydroxyapatite material (HA) coating and prepare；Described top shoe fixes device 107, the fixing device 207 of sliding block is specially following several one or a combination set of: the outside bur structure of wedge angle, prominent spine, diagonal screw duct；The concrete structure of described " prominent spine " meets following requirement: offering groove on adjacent vertebral body sclerotin, the correspondence position at the artificial disc after arthroplasty that contact corresponding to this groove arranges the fin installed with slot fit；
Following position requires to carry out the radiused process of rounding: top shoe is slidably matched face 104 and top shoe extends upper recess surface 105 junction, the top shoe being directly connected to or connected by transition face extends the corner of the attachment structure 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, is directly connected to or the sliding block that connected by transition face extends the corner of attachment structure between convex surface 205 and sliding block sliding part edge surface 206 down；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 transverse diameter and the ratio of sagittal diameter are 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, it is possible to 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 completely, for three-member type (whole artificial disc after arthroplasty is mainly made up of three structural members), it specifically forms with top shoe 1, sliding block 2, intermediate slider 3 these three functional part, and intermediate slider 3 is arranged between the above two and its cooperation that contacts with each other with the former two respectively constitutes sliding area；Top shoe 1 and sliding block 2 are additionally provided with and fix the fixing device connected 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 is constituted by top shoe sliding part 102 and top shoe soleplate part 103, wherein: top shoe sliding part 102 is provided with for coordinating the sliding area and top shoe sliding area 101 contacted with intermediate slider 3 away from the centre of top shoe soleplate part 103 side；Top shoe sliding area 101 is slidably matched by the top shoe at centrally located place face 104 and be arranged on the be slidably matched top shoe of both sides, face 104 of top shoe and extend upper recess surface 105 and constitute；For coordinate with sliding block 2 constitute bend and stretch/the top shoe sliding part edge surface 106 of lateral bending position limiting structure is arranged in the top shoe sliding part 102 periphery away from the top shoe sliding area 101 of side, top shoe soleplate part 103 side；
Top shoe soleplate part 103 is provided with on the side away from top shoe sliding part 102 side for fixing the fixing device 107 of the top shoe connected with adjacent vertebral body；
2. sliding block 2 main part is connected to one is constituted by sliding block sliding part 202 and sliding block soleplate part 203, wherein: sliding block sliding part 202 is provided with for coordinating the sliding area and sliding block sliding area 201 contacted with intermediate slider 3 away from the centre of sliding block soleplate part 203 side；Sliding block sliding area 201 is slidably matched by the sliding block at centrally located place face 204 and be arranged on the be slidably matched sliding block of both sides, face 204 of sliding block and extend concave surface 205 and constitute；For coordinating the sliding block sliding part edge surface 206 constituting position limiting structure to be arranged in the sliding block sliding part 202 periphery away from the sliding block sliding area 201 of side, sliding block soleplate part 203 side with top shoe 1；
Sliding block soleplate part 203 is provided with on the side away from sliding block sliding part 202 side for fixing the fixing device 207 of the sliding block connected with adjacent vertebral body；
3. the upper and lower surface of intermediate slider 3 is provided with the face 104 that is slidably matched respectively with top shoe, sliding block is slidably matched the face that is slidably matched that face 204 contacts: the upper mating surface 303 of intermediate slider slip, the lower mating surface 304 of intermediate slider slip；On intermediate slider slides mating surface 303 and intermediate slider slide under the both sides of mating surface 304 be respectively arranged with extend upper recess surface 105 with top shoe respectively, 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 slide over the periphery in region 301 and intermediate slider slip underneath region 302 be also respectively provided with respectively the intermediate slider top edge face 307 of layout corresponding to top shoe sliding part edge surface 106, sliding block sliding part edge surface 206, intermediate slider lower limb face 308；
4. top shoe the slide face that contacts with each other of upper both mating surfaces 303 of face 104 and intermediate slider that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, another one Internal periphery face；Sliding block the slide face that contacts with each other of lower both mating surfaces 304 of face 204 and intermediate slider 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 Internal periphery face；
5. top shoe 1 and intermediate slider 3 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤9 °, sliding block 2 and intermediate slider 3 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤9 °, and namely top shoe 1 and sliding block 2 the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤18 °；
6. in the lateral surface centre away from the top shoe soleplate part 103 of top shoe 1 and sliding block 2 contact surface side and sliding block soleplate part 203, it is respectively arranged with and coordinates top shoe arcuate surface 108, the sliding block arcuate surface 208 contacted with adjacent vertebral body.
Described artificial disc after arthroplasty meet one of following requirement or its certain combination:
The concrete structure limiting the two relative rotation angle scope on top shoe 1 and sliding block 2 in the horizontal direction being perpendicular to its main matching surface center meets following requirement: be each provided with 1 top shoe respectively extend upper recess surface 105 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) in face 104 of top shoe；It is each provided with 1 sliding block respectively extends concave surface 205 in the be slidably matched both sides (the described artificial disc after arthroplasty sagittal plane left and right sides) in 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 extend upper recess surface 105 with top shoe respectively, 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 extends lower convex surface 306 and stretches out to the described artificial disc after arthroplasty sagittal plane left and right sides respectively and be respectively embedded in that top shoe extends upper recess surface 105, sliding block extends in the groove-like structure of concave surface 205 and can carry out a range of level of relative rotation wherein.
In described artificial disc prosthese, top shoe 1 and sliding block 2 constitute fit structure by means of intermediate slider 3, wherein: top shoe 1 relative to sliding block 2 in the horizontal direction being perpendicular to its main matching surface center therebetween relative rotation angle area requirement be≤12 °；Wherein: for rotary moveable scope≤12 ° of the artificial disc after arthroplasty of cervical vertebra, for rotary moveable scope≤6 ° of the artificial disc after arthroplasty of lumbar vertebra；
Described artificial disc after arthroplasty top shoe sliding part edge surface 106 on sagittal plane, both sliding block sliding part edge surfaces 206 angle α≤15 ° respectively and between intermediate slider top edge face 307, intermediate slider lower limb face 308, realizing the full range of movement of flexion-extension motion on sagittal plane is 30 °, wherein for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 30 °, for the flexion-extension motion scope of artificial disc after arthroplasty of lumbar vertebra up to 24 °；
Described artificial disc after arthroplasty top shoe sliding part edge surface 106 on coronalplane, between sliding block sliding part edge surface 206 and intermediate slider top edge face 307, lower limb face 308 angle of release α≤10 °, realize the range of activity of (lateral bending) on coronalplane maximum 20 °, wherein for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 20 °, for the flexion-extension motion scope of artificial disc after arthroplasty of lumbar vertebra up to 12 °.
Top shoe sliding part 102 and top shoe soleplate part 103 meet one of following requirement: one, and the two is able to the Split type structure part fitted together, and for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Sliding block sliding part 202 and sliding block soleplate part 203 meet one of following requirement: one, and the two is able to the Split type structure part fitted together, and for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；The outer edge away from artificial disc after arthroplasty center of intermediate slider 3 is provided with and prevents from slipping structure 309, for the edge barrier structure longitudinally widened to unilateral or bilateral；Top shoe sliding part 102, sliding block sliding part 202, intermediate slider 3 material be polyether-ether-ketone resin (PEEK) or high purity carbon fiberreinforced polyether-ether-ketone resin material (CFR-PEEK)；Top shoe soleplate part 103, sliding block soleplate part 203 low elastic modulus titanium alloy Ti-Nb-Zr-Sn.
10, according to one of them described artificial disc after arthroplasty of claim 7-9, it is characterised in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination: top shoe be slidably matched face 204, the intermediate slider of face 104, sliding block that be slidably matched slides upper mating surface 303 and the intermediate slider lower mating surface 304 that slides is supported or opposed from prosthese center side shifting 2 8mm on sagittal plane；Angle of release α≤15 ° between top shoe sliding part edge surface 106 and intermediate slider top edge face 307, angle of release α≤15 ° between sliding block sliding part edge surface 206 and intermediate slider lower limb face 308；Distance between top shoe edge surface 106, sliding block edge surface 206 and intermediate slider edge surface is corresponding with angle of release α, jointly by the flexion angles Bit andits control in the direction 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 not easily quantitative description herein, it is relevant with the diameter in a certain direction of whole artificial disc, with to reach to bend and stretch angle also relevant；
Described artificial disc after arthroplasty is additionally provided with saturating X-ray or can the labelling of X-ray thoroughly；Labelling is so that in operation process and postoperative inspection and adjustment；Contact surface plasma spraying method or other method for the top shoe soleplate part 103 contacted with each other with adjacent vertebral bodies or sliding block soleplate part 203 carry out hydroxyapatite material (HA) coating and process；Device 107 that described top shoe is fixing with contiguous terminal plate of vertebral body and/or the sliding block device 207 fixing with contiguous terminal plate of vertebral body are specially following several one or a combination set of: the outside bur structure of wedge angle, dash forward spine, diagonal screw duct；The concrete structure of described " prominent spine " meets following requirement: offering groove on adjacent vertebral body sclerotin, the correspondence position at the artificial disc after arthroplasty that contact corresponding to this groove arranges the fin installed with slot fit；
Following position requires to carry out the radiused process of rounding: top shoe is slidably matched face 104 and top shoe extends upper recess surface 105 junction, the top shoe being directly connected to or connected by transition face extends the corner of the attachment structure 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, is directly connected to or the corner of attachment structure between the sliding block extension concave surface 205 and the sliding block sliding part edge surface 206 that are connected by transition face；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 above 303 and intermediate slider extend upper convex surface 305 junction, be directly connected to or the intermediate slider that connected by transition face extended and goes up that between convex surface 305 and intermediate slider top edge face 307 corner of attachment structure；Intermediate slider be slidably matched following 304 and intermediate slider extend lower convex surface 306 junction, be directly connected to or the intermediate slider that connected by transition face extend down that between convex surface 306 and intermediate slider lower limb face 308 corner of attachment structure；
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 transverse diameter and the ratio of sagittal diameter are 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, it is possible to 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 completely, form with top shoe (1) and sliding block (2) the two functional part, top shoe (1) with sliding block (2) are separately provided for coordinating therebetween the sliding area contacted；Top shoe (1) and sliding block (2) are additionally provided with and fix the fixing device connected 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 is constituted by top shoe sliding part (102) and top shoe soleplate part (103), wherein: top shoe sliding part (102) is provided with for coordinating the sliding area and top shoe sliding area (101) contacted with sliding block (2) away from the centre of top shoe soleplate part (103) side；Top shoe sliding area (101) be slidably matched by the top shoe at centrally located place face (104) and be arranged on top shoe be slidably matched face (104) both sides top shoe extend upper recess surface (105) constitute；For coordinate with sliding block (2) constitute bend and stretch/top shoe sliding part edge surface (106) of lateral bending position limiting structure is arranged in the top shoe sliding part (102) periphery away from the top shoe sliding area (101) of top shoe soleplate part (103) side, side；
Top shoe soleplate part (103) is provided with on the side away from top shoe sliding part (102) side for fixing the fixing device (107) of the top shoe connected with adjacent vertebral body；
2. sliding block (2) main part is connected to one is constituted by sliding block sliding part (202) and sliding block soleplate part (203), wherein: sliding block sliding part (202) is provided with for coordinating the sliding area and sliding block sliding area (201) contacted with top shoe (1) away from the centre of sliding block soleplate part (203) side；Sliding block sliding area (201) is slidably matched by the sliding block at centrally located place 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 constitute；For coordinating sliding block sliding part edge surface (206) constituting position limiting structure to be arranged in the sliding block sliding part (202) periphery away from the sliding block sliding area (201) of sliding block soleplate part (203) side, side with top shoe (1)；
Sliding block soleplate part (203) is provided with on the side away from sliding block sliding part (202) side for fixing the fixing device (207) of the sliding block connected with adjacent vertebral body；
3. top shoe the two the face that contacts with each other, face (204) that is slidably matched with sliding block, face (104) 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 Internal periphery face；
4. top shoe (1) and sliding block (2) the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤18 °；
5. in the lateral surface centre away from top shoe soleplate part (103) of top shoe (1) and sliding block (2) contact surface side and sliding block soleplate part (203), it is respectively arranged with and coordinates top shoe arcuate surface (108), the sliding block arcuate surface (208) contacted with adjacent vertebral body.
2. artificial disc after arthroplasty according to claim 1, it is characterised in that:
The concrete structure limiting the two relative rotation angle scope on top shoe (1) and sliding block (2) in the horizontal direction being perpendicular to its main matching surface center meets following requirement:
It is each provided with 1 top shoe respectively extends upper recess surface (105) in the be slidably matched both sides in face (104) of top shoe；Accordingly, convex surface (205) under 1 sliding block extends it is each provided with respectively in the be slidably matched both sides in face (204) of sliding block；That is: the lower convex surface (205) of sliding block extension stretches out to the described artificial disc after arthroplasty sagittal plane left and right sides and is embedded in two groove-like structure of top shoe extension upper recess surface (105) and can extend in upper recess surface (105) at top shoe and carries out level of relative rotation.
3. artificial disc after arthroplasty according to claim 2, it is characterised 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 in the horizontal direction being perpendicular to its main matching surface center is≤12 °, it is 12 ° that realization horizontally rotates maximum angle scope, wherein: for rotary moveable scope≤12 ° of the artificial disc after arthroplasty of cervical vertebra, for rotary moveable scope≤6 ° of the artificial disc after arthroplasty of lumbar vertebra；
Angle α≤30 ° of described artificial disc after arthroplasty top shoe sliding part edge surface (106) on sagittal plane and sliding block sliding part edge surface (206), the maximum angle range of activity realizing flexion-extension motion on sagittal plane is 30 °, wherein: for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 30 °, for the flexion-extension motion scope of the artificial disc after arthroplasty of lumbar vertebra up to 24 °；
Angle of release α≤20 ° of described artificial disc after arthroplasty top shoe sliding part edge surface (106) on coronalplane and sliding block sliding part edge surface (206), realizing the angular range that on coronalplane, lateral bending range of activity is maximum is 20 °, wherein: for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 20 °, for the flexion-extension motion scope of the artificial disc after arthroplasty of lumbar vertebra up to 12 °.
4. artificial disc after arthroplasty according to claim 3, it is characterised 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, the two is able to the Split type structure part fitted together, for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Sliding block sliding part (202) and sliding block soleplate part (203) meet one of following requirement: one, the two is able to the Split type structure part fitted together, for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Top shoe sliding part (102), sliding block sliding part (202) material be polyether-ether-ketone resin or high purity carbon fiberreinforced polyether-ether-ketone resin material；Top shoe soleplate part (103), sliding block soleplate part (203) the titanium alloy Ti-Nb-Zr-Sn that material is low elastic modulus.
5. according to one of them described artificial disc after arthroplasty of claim 2-4, it is characterised in that: described artificial disc after arthroplasty meet one of following requirement or its certain combination:
Top shoe is slidably matched face (104) and sliding block is slidably matched face (204) supports or opposes from prosthese center on sagittal plane side shifting 2 8mm；
Described artificial disc after arthroplasty is additionally provided with saturating X-ray or can the labelling of X-ray thoroughly；
Use plasma spraying method to carry out hydroxyapatite material coating for the contact surface of top shoe soleplate part (103) contacted with each other with adjacent vertebral bodies or sliding block soleplate part (203) to prepare；
Described top shoe fixes device (107), the fixing device (207) of sliding block is specially following several one or a combination set of: the outside bur structure of wedge angle, prominent spine, diagonal screw duct；The concrete structure of described " prominent spine " meets following requirement: offering groove on adjacent vertebral body sclerotin, the correspondence position at the artificial disc after arthroplasty that contact corresponding to this groove arranges the fin installed with slot fit；
Following position requires to carry out the radiused process of rounding: top shoe is slidably matched face (104) and top shoe extends upper recess surface (105) junction, is directly connected to or the corner of attachment structure between top shoe extension upper recess surface (105) and top shoe sliding part edge surface (106) that are connected by transition face；Be slidably matched face (204) and sliding block of sliding block extends lower convex surface (205) junction；
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 transverse diameter and the ratio of sagittal diameter are following one of several: 4:3,5:3,2:1.
6. an artificial disc after arthroplasty, for substituting the intervertebral disc of cervical vertebra and lumbar vertebra completely, forming with top shoe (1), sliding block (2), intermediate slider (3) these three functional part, intermediate slider (3) is arranged between the above two and its cooperation that contacts with each other with the former two respectively constitutes sliding area；Top shoe (1) and sliding block (2) are additionally provided with and fix the fixing device connected 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 is constituted by top shoe sliding part (102) and top shoe soleplate part (103), wherein: top shoe sliding part (102) is provided with for coordinating the sliding area and top shoe sliding area (101) contacted with intermediate slider (3) away from the centre of top shoe soleplate part (103) side；Top shoe sliding area (101) be slidably matched by the top shoe at centrally located place face (104) and be arranged on top shoe be slidably matched face (104) both sides top shoe extend upper recess surface (105) constitute；For coordinate with sliding block (2) constitute bend and stretch/top shoe sliding part edge surface (106) of lateral bending position limiting structure is arranged in the top shoe sliding part (102) periphery away from the top shoe sliding area (101) of top shoe soleplate part (103) side, side；
Top shoe soleplate part (103) is provided with on the side away from top shoe sliding part (102) side for fixing the fixing device (107) of the top shoe connected with adjacent vertebral body；
2. sliding block (2) main part is connected to one is constituted by sliding block sliding part (202) and sliding block soleplate part (203), wherein: sliding block sliding part (202) is provided with for coordinating the sliding area and sliding block sliding area (201) contacted with intermediate slider (3) away from the centre of sliding block soleplate part (203) side；Sliding block sliding area (201) be slidably matched by the sliding block at centrally located place face (204) and be arranged on sliding block be slidably matched face (204) both sides sliding block extend concave surface (205) constitute；For coordinating sliding block sliding part edge surface (206) constituting position limiting structure to be arranged in the sliding block sliding part (202) periphery away from the sliding block sliding area (201) of sliding block soleplate part (203) side, side with top shoe (1)；
Sliding block soleplate part (203) is provided with on the side away from sliding block sliding part (202) side for fixing the fixing device (207) of the sliding block connected with adjacent vertebral body；
3. the upper and lower surface of intermediate slider (3) is provided with the face (104) that is slidably matched respectively with top shoe, sliding block is slidably matched the face that is slidably matched that face (204) contacts: the upper mating surface (303) of intermediate slider slip, the lower mating surface (304) of intermediate slider slip；On intermediate slider slides mating surface (303) and intermediate slider slide the both sides of lower mating surface (304) be respectively arranged with extend upper recess surface (105) with top shoe respectively, sliding block extend the corresponding intermediate slider of concave surface (205) extend above convex surface (305), convex surface (306) under intermediate slider extension；Intermediate slider slide over the periphery in region (301) and intermediate slider slip underneath region (302) be also respectively provided with respectively the intermediate slider top edge face (307) of layout corresponding to top shoe sliding part edge surface (106), 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 contacts with each other of upper mating surface (303) of sliding that is slidably matched is all the part of the sphere that radius of curvature is identical, and one is outer surface, another one Internal periphery face；Sliding block face (204) and intermediate slider the two the face that contacts with each other of lower mating surface (304) of sliding 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 Internal periphery face；
5. top shoe (1) and intermediate slider (3) the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤9 °, sliding block (2) and intermediate slider (3) the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤9 °, and namely top shoe (1) and sliding block (2) the two relative rotation angle area requirement in the horizontal direction being perpendicular to its main matching surface center is≤18 °；
6. the lateral surface centre of top shoe soleplate part (103) and sliding block soleplate part (203), is respectively arranged with and coordinates top shoe arcuate surface (108), the sliding block arcuate surface (208) contacted with adjacent vertebral body.
7. artificial disc after arthroplasty according to claim 6, it is characterised in that: described artificial disc after arthroplasty meets one of following requirement or its certain combination:
The concrete structure limiting the two relative rotation angle scope on top shoe (1) and sliding block (2) in the horizontal direction being perpendicular to its main matching surface center meets following requirement:
It is each provided with 1 top shoe respectively extends upper recess surface (105) in the be slidably matched both sides in face (104) of top shoe；It is each provided with 1 sliding block respectively extends concave surface (205) in the be slidably matched both sides in 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 extend upper recess surface (105) with top shoe respectively, sliding block extend the corresponding intermediate slider of concave surface (205) extend above convex surface (305), convex surface (306) under intermediate slider extension；
Intermediate slider extends upper convex surface (305), intermediate slider extends lower convex surface (306) and stretches out to the described artificial disc after arthroplasty sagittal plane left and right sides respectively and be respectively embedded in that top shoe extends upper recess surface (105), sliding block extends in the groove-like structure of concave surface (205) and can carry out level of relative rotation wherein.
8. artificial disc after arthroplasty according to claim 7, it is characterised 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) constitute fit structure by means of intermediate slider (3), top shoe (1) relative to sliding block (2) in the horizontal direction being perpendicular to its main matching surface center therebetween relative rotation angle area requirement be≤12 °；Wherein: for rotary moveable scope≤12 ° of the artificial disc after arthroplasty of cervical vertebra, for rotary moveable scope≤6 ° of the artificial disc after arthroplasty of lumbar vertebra；
The two angle α≤15 ° respectively and between intermediate slider top edge face (307), intermediate slider lower limb face (308) of described artificial disc after arthroplasty top shoe sliding part edge surface (106) on sagittal plane, sliding block sliding part edge surface (206), realizing the full range of movement of flexion-extension motion on sagittal plane is 30 °, wherein for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 30 °, for the flexion-extension motion scope of artificial disc after arthroplasty of lumbar vertebra up to 24 °；
Described artificial disc after arthroplasty top shoe sliding part edge surface (106) on coronalplane, between sliding block sliding part edge surface (206) and intermediate slider top edge face (307), lower limb face (308) angle of release α≤10 °, realize the range of activity of maximum 20 ° of lateral bending on coronalplane, wherein for the flexion-extension motion scope of artificial disc after arthroplasty of cervical vertebra up to 20 °, for the flexion-extension motion scope of artificial disc after arthroplasty of lumbar vertebra up to 12 °.
9. artificial disc after arthroplasty according to claim 8, it is characterised 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, the two is able to the Split type structure part fitted together, for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
Sliding block sliding part (202) and sliding block soleplate part (203) meet one of following requirement: one, the two is able to the Split type structure part fitted together, for non-dismountable or detachable block, utilize draw-in groove each other or screw is fixing connects；Its two, the two is the integral structure component of identical material；
The outer edge away from artificial disc after arthroplasty center of intermediate slider (3) is provided with and prevents from slipping structure (309), for the edge barrier structure longitudinally widened to unilateral or bilateral；
Top shoe sliding part (102), sliding block sliding part (202), intermediate slider (3) material be polyether-ether-ketone resin or high purity carbon fiberreinforced polyether-ether-ketone resin material；Top shoe soleplate part (103), sliding block soleplate part (203) low elastic modulus titanium alloy Ti-Nb-Zr-Sn.
10. according to one of them described artificial disc after arthroplasty of claim 7-9, it is characterised in that: described artificial disc after arthroplasty meet one of following requirement or its certain combination:
Top shoe be slidably matched face (204), the intermediate slider of face (104), sliding block that be slidably matched slides upper mating surface (303) and the intermediate slider lower mating surface (304) that slides is supported or opposed from prosthese center side shifting 2 8mm on sagittal plane；
Described artificial disc after arthroplasty is additionally provided with saturating X-ray or can the labelling of X-ray thoroughly；
Contact surface plasma spraying method or other method for top shoe soleplate part (103) contacted with each other with adjacent vertebral bodies or sliding block soleplate part (203) carry out hydroxyapatite material coating process；
Device (107) that described top shoe is fixing with contiguous terminal plate of vertebral body and/or the sliding block device (207) fixing with contiguous terminal plate of vertebral body are specially following several one or a combination set of: the outside bur structure of wedge angle, dash forward spine, diagonal screw duct；The concrete structure of described " prominent spine " meets following requirement: offering groove on adjacent vertebral body sclerotin, the correspondence position at the artificial disc after arthroplasty that contact corresponding to this groove arranges the fin installed with slot fit；
Following position requires to carry out the radiused process of rounding: top shoe is slidably matched face (104) and top shoe extends upper recess surface (105) junction, is directly connected to or the corner of attachment structure between top shoe extension upper recess surface (105) and top shoe sliding part edge surface (106) that are connected by transition face；Be slidably matched face (204) and sliding block of sliding block extends concave surface (205) junction；Intermediate slider is slidably matched above (303) and intermediate slider extends upper convex surface (305) junction, is directly connected to or the intermediate slider that connected by transition face is extended and goes up that between convex surface (305) and intermediate slider top edge face (307) corner of attachment structure；Intermediate slider is slidably matched following (304) and intermediate slider extends lower convex surface (306) junction, is directly connected to or the intermediate slider that connected by transition face extends down that between convex surface (306) and intermediate slider lower limb face (308) corner of attachment structure；
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 transverse diameter and the ratio of sagittal diameter are following one of several: 4:3,5:3,2:1.
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| CN104707172B (en) * | 2013-12-12 | 2017-03-29 | 中国科学院深圳先进技术研究院 | A kind of artificial intervertebral disk and preparation method thereof |
| CN105310802B (en) * | 2014-06-03 | 2017-09-19 | 深圳兰度生物材料有限公司 | Artificial intervertebral disk and preparation method thereof |
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