CN105030385A - All-organic high molecular material ankle joint prosthesis - Google Patents

All-organic high molecular material ankle joint prosthesis Download PDF

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Publication number
CN105030385A
CN105030385A CN201510534398.1A CN201510534398A CN105030385A CN 105030385 A CN105030385 A CN 105030385A CN 201510534398 A CN201510534398 A CN 201510534398A CN 105030385 A CN105030385 A CN 105030385A
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CN
China
Prior art keywords
prosthese
tibia
anklebone
pad
strain
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201510534398.1A
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Chinese (zh)
Inventor
朱健
徐龙伟
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Suzhou Zhongke Biomedical Material Co., Ltd.
Original Assignee
Jiangsu Okani Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jiangsu Okani Medical Technology Co Ltd filed Critical Jiangsu Okani Medical Technology Co Ltd
Priority to CN201510534398.1A priority Critical patent/CN105030385A/en
Priority to PCT/CN2015/000732 priority patent/WO2017031608A1/en
Publication of CN105030385A publication Critical patent/CN105030385A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/42Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes

Abstract

The invention relates to an all-organic high molecular material ankle joint prosthesis which comprises a tibia support prosthesis, a tibia pad and an anklebone prosthesis. The tibia support prosthesis is connected with the tibia pad, the tibia pad is connected with the anklebone prosthesis, and the tibia support prosthesis and the anklebone prosthesis are both formed by poly(ether ether ketone) (PEEK) or derivatives of the poly(ether ether ketone) (PEEK); the tibia pad is formed by ultra-high molecular weight polyethylene (UHMWPE). According to the all-organic high molecular material ankle joint prosthesis, inner plant parts are composed of high molecular materials, and therefore the problems of metal corrosion and the allergy and toxicity which are possibly caused by metal are solved; the elasticity modulus of the PEEK materials is matched with that of the natural bones, and therefore stress shieding problem is solved; the abrasion of the prosthesis on the sliding friction surface of the cartilago articularis is reduced.

Description

A kind of full stress-strain macromolecular material ankle prosthesis
Technical field
The present invention relates to a kind of medical rehabilitation instrument, more specifically, relate to a kind of full stress-strain macromolecular material ankle prosthesis.
Background technology
Total ankle joint replacement and hip joint and knee joint are all used to motion (YuJJ, SheskierS.Totalanklereplacement--evolutionofthetechnolog yandfutureapplications.BullHospJtDis (2013) .2014 alleviating Human Osteoarthritis pain and retain nature ankle joint; 72 (1): 120-8).But total ankle joint replacement relative to hip joint or kneed treatment also very immature.Hip joint and knee replacements have developed into can long-term remission pain improve function, but be the effect that ankle fusion or ankle joint replacement are all not good for a long time.The ankle joint replacement of height-limited bone cement prosthese is taked to stop using due to unacceptable high failure rate and complication in early days.Although fusion remains " goldstandard " for the treatment of ankle arthritis in whole latter stage, the degeneration of adjacent joints and minimizing gait efficiency, the interest that result in ankle joint replacement revives.The patient of novel artificial ankle prosthesis has 82% long-term effect feeling outstanding or good, and such effect for ankle fusion patient only have 72% (YuJJ, SheskierS.Totalanklereplacement--evolutionofthetechnolog yandfutureapplications.BullHospJtDis (2013) .2014; 72 (1): 120-8).Total ankle joint replacement has become the feasible selection operation of a treatment ankle arthritis, and is more applied gradually.
Early stage ankle joint is replaced prosthese and is made up of a polyethylene tibial component and metal astragalus component, with polyethylene tibial component by bone cement and bone directly fixing (GougouliasNE, KhannaA, MaffulliN.Historyandevolutionintotalanklearthroplasty.Br MedBull.2009; 89:111-51.WithPermission).Follow-on development comprises ultra-high molecular weight polyethylene (UHMWPE) assembly and is fixed to tibia support, designs and becomes semi-constrained (such as Agility prosthese) from staff cultivation.Full ankle joint displacement (STAR) of described Buechel-Pappas (BP) prosthese and Scandinavia all comprises a slidably ultra-high molecular weight polyethylene liner (three parts), and its permission is slided at the either side (tibia and astragalus) of ultra-high molecular weight polyethylene parts.Cement reaction is given up gradually, and changes biotype into and fix.
The material that ankle prosthesis used at present adopts comprises metal (CoCrMo or Ti alloy) and ultra-high molecular weight polyethylene (UHMWPE).Current ankle prosthesis also has a lot of clinical problem (PappasMJ, BuechelFFSr.Failuremodesofcurrenttotalanklereplacementsy stems.ClinPodiatrMedSurg.2013Apr; 30 (2): 123-43.doi:10.1016/j.cpm.2012.10.002.Review).In a Meta-analyzes, (the HaddadSL such as Haddad, CoetzeeJC, EstokR, FahrbachK, BanelD, NalysnykL.Intermediateandlong-termoutcomesoftotalanklear throplastyandanklearthrodesis.Asystematicreviewofthelite rature.JBoneJointSurgAm.2007Sep; 89 (9): 1899-905.Review) found that the survival rate of total ankle joint replacement 5 years and 10 years is respectively 78% and 77%.Have in the revision rate of 7% and loosen the overwhelming majority's (28%) accounting for case of sinking.In current hip, knee joint, ubiquitous problem also should exist in ankle prosthesis, and comprising may to the patient of metal sensitivity; Wearing and tearing (the ReindersJ of prosthese, vonStillfriedF, AltanE, SonntagR, HeitzmannDW, KretzerJP.Force-controlleddynamicweartestingoftotalankle replacements.ActaBiomater.2015Jan; 12:332-40.doi:10.1016/j.actbio.2014.10.036.Epub2014Oct31), the aseptic of prosthese loosens (McInnesKA, YoungerAS, OxlandTR.Initialinstabilityintotalanklereplacement:acada vericbiomechanicalinvestigationoftheSTARandagilityprosth eses.JBoneJointSurgAm.2014Sep3; 96 (17): e147.doi:10.2106/JBJS.L.01690) and stress shielding (BouguechaA, WeigelN, BehrensBA, Stukenborg-ColsmanC, WaizyH.Numericalsimulationofstrain-adaptiveboneremodelli ngintheanklejoint.BiomedEngOnline.2011Jul5; 10:58.doi:10.1186/1475-925X-10-58).
Therefore, a kind of new artificial ankle joint overcoming above-mentioned defect expects.
Summary of the invention
For above-mentioned technical problem to be solved, the object of this invention is to provide a kind of full stress-strain macromolecular material ankle prosthesis.
In order to realize foregoing invention, the present invention adopts following technical scheme:
A kind of full stress-strain macromolecular material ankle prosthesis, comprise tibia support prosthese, tibia pad and anklebone prosthese, described tibia support prosthese is connected with described tibia pad, and described tibia pad is connected with described anklebone prosthese, wherein:
Described tibia support prosthese is grouped into by the upright projection in top and lower connecting part, the top of described lower frame portion is plane, described upright projection is arranged on the plane, the end face indent be connected with described tibia pad of described tibia support prosthese, the inside of described tibia support prosthese is extended with outstanding ridge downwards, and described ridge surrounds described tibia pad at least in part;
The end face evagination that described tibia pad is connected with described tibia support prosthese, the evagination end face of described tibia pad and the indent end face of described tibia support prosthese match, and the end face that the bottom of described tibia pad is connected with described anklebone prosthese is arcs of recesses sliding surface;
The end face that the top of described anklebone prosthese is connected with described tibia pad is convex sliding surface, described convex sliding surface and described arcs of recesses sliding surface match, the end face undulate shape that the top of described anklebone prosthese is connected with described tibia pad, the bottom of described anklebone prosthese is provided with three outstanding ridges;
Described tibia support prosthese and described anklebone prosthese are formed by polyether-ether-ketone or derivatives thereof; Described tibia pad is made up of ultra-high molecular weight polyethylene.
Further, between described tibia support prosthese with described tibia pad for assembly type is connected.
Further, described tibia pad and described anklebone prosthese connect to form articular surface.
Further, the near-end of described tibia support prosthese is crude or porous layer.
Further, the far-end of described anklebone prosthese is crude or porous layer.
Further, described thickness that is crude or porous layer is 0.5-1.0 millimeter.
Further, described crude or porous layer is made up of biocompatibility metal or its alloy.
Further, described biocompatibility metal or its alloy comprise vitallium, titanium or titanium alloy, tantalum or tantalum alloy, rustless steel and zirconium-niobium alloy.
Further, described biocompatibility metal or its alloy are titanium or titanium alloy.
Further, described three outstanding ridges are triangularly arranged.
Owing to adopting above technical scheme, beneficial effect of the present invention is:
1) the implants parts of ankle prosthesis provided by the invention are made up of macromolecular material, thus allergy, toxicity problem that reduction metal erosion and metal may cause;
2) elastic modelling quantity and the natural bone of polyether-ether-ketone (PEEK) material in the present invention match, and alleviate stress shielding problem;
3) the PEEK prosthese in the present invention reduces the wear problem of the sliding friction surface of articular cartilage;
Accompanying drawing explanation
Fig. 1 is the structural representation of ankle prosthesis provided by the invention.
Description of reference numerals
1 tibia support prosthese, 11 planes, 12 projections, 13 ridges, 2 tibia pads, 21 arcs of recesses sliding surfaces, 3 anklebone prostheses, 31 convex sliding surfaces, 32 ridges, 33 ridges, 34 ridges
Detailed description of the invention
In order to make object of the present invention, technical scheme and advantage clearly understand, below in conjunction with drawings and Examples, the present invention is described in further detail.Should be appreciated that specific embodiment described herein only in order to explain the present invention, be not intended to limit the present invention.
As shown in Figure 1, a kind of full stress-strain macromolecular material ankle prosthesis provided by the invention, comprise tibia support prosthese 1, tibia pad 2 and anklebone prosthese 3, tibia support prosthese 1 is connected with tibia pad 2, tibia pad 2 is connected with anklebone prosthese 3, and tibia support prosthese 1 and anklebone prosthese 3 are formed by polyether-ether-ketone (PEEK) or derivatives thereof; Tibia pad 2 is made up of ultra-high molecular weight polyethylene (UHMWPE).
Referring again to Fig. 1, as shown in the figure, tibia support prosthese 1 is grouped into by the upright projection 12 in top and lower connecting part, the top of lower frame portion is plane 11, upright projection 12 is arranged in plane 11, the end face indent be connected with tibia pad 2 of tibia support prosthese 1, the inside of tibia support prosthese 1 is extended with outstanding ridge 13 downwards, and ridge 13 surrounds tibia pad 2 at least in part; The end face evagination that tibia pad 2 is connected with tibia support prosthese 1, the evagination end face of tibia pad 2 and the indent end face of tibia support prosthese 1 match, and the end face that the bottom of tibia pad 2 is connected with anklebone prosthese 3 is arcs of recesses sliding surface 21; The end face that the top of anklebone prosthese 3 is connected with tibia pad 2 is convex sliding surface 31, convex sliding surface 31 and arcs of recesses sliding surface 21 match, the end face undulate shape that the top of anklebone prosthese 3 is connected with tibia pad 2, the bottom of anklebone prosthese 3 is provided with three outstanding ridges 32,33,34; Article three, outstanding ridge 32,33,34 is triangularly arranged.
In technique scheme, for assembly type is connected between tibia support prosthese 1 with tibia pad 2.
In technique scheme, tibia pad 2 and anklebone prosthese 3 connect to form articular surface.
In technique scheme, the near-end of tibia support prosthese 1 is crude or porous layer; The far-end of anklebone prosthese 3 is crude or porous layer.
In technique scheme, thickness that is crude or porous layer is 0.5-1.0 millimeter.
In technique scheme, crude or porous layer is by biocompatibility metal or its alloy; Biocompatibility metal or its alloy comprise vitallium, titanium or titanium alloy, tantalum or tantalum alloy, rustless steel and zirconium-niobium alloy; Biocompatibility metal or its alloy are preferably titanium or titanium alloy.
The present invention proposes the ankle prosthesis system be made up of polyether-ether-ketone (PEEK) or derivatives thereof first.Ankle prosthesis structure of the present invention, owing to creatively have employed PEEK or derivatives thereof material, makes the tribological property of PEEK to ultra-high molecular weight polyethylene (UHMWPE) have improvement, improves the Clinical practice of urgent case joint replacement.In the present invention, by the coupling of PEEK and High molecular weight polyethylene (UHMWPE) sliding surface, decrease wearing and tearing, add the buffering of PEEK to model of human ankle, reduce the contact pressure on surface, further reduce the wearing and tearing to prismatic face, add PEEK prosthese and load effectively can be conducted to bone, thus decrease stress shielding.
In addition, the present invention uses owing to decreasing metal material the clinical problem caused, such as, and the problem such as sensitivity, toxicity, pseudotumor of metal ion.Because the elastic modelling quantity (3GPa) of PEEK material is well below the elastic modelling quantity (200GPa) of metal, and it is basically identical with the elastic modelling quantity (0.8 ~ 17GPa) of bone, so, adopt PEEK material can reduce the stress shielding of bone, avoid bone resorption, thus reach the effect of bone reservation good for a long time.
The foregoing is only preferred embodiment of the present invention, be not used for limiting practical range of the present invention; If do not depart from the spirit and scope of the present invention, the present invention is modified or equivalent to replace, in the middle of the protection domain that all should be encompassed in the claims in the present invention.

Claims (10)

1. a full stress-strain macromolecular material ankle prosthesis, is characterized in that, comprises tibia support prosthese, tibia pad and anklebone prosthese, and described tibia support prosthese is connected with described tibia pad, and described tibia pad is connected with described anklebone prosthese, wherein:
Described tibia support prosthese is grouped into by the upright projection in top and lower connecting part, the top of described lower frame portion is plane, described upright projection is arranged on the plane, the end face indent be connected with described tibia pad of described tibia support prosthese, the inside of described tibia support prosthese is extended with outstanding ridge downwards, and described ridge surrounds described tibia pad at least in part;
The end face evagination that described tibia pad is connected with described tibia support prosthese, the evagination end face of described tibia pad and the indent end face of described tibia support prosthese match, and the end face that the bottom of described tibia pad is connected with described anklebone prosthese is arcs of recesses sliding surface;
The end face that the top of described anklebone prosthese is connected with described tibia pad is convex sliding surface, described convex sliding surface and described arcs of recesses sliding surface match, the end face undulate shape that the top of described anklebone prosthese is connected with described tibia pad, the bottom of described anklebone prosthese is provided with three outstanding ridges;
Described tibia support prosthese and described anklebone prosthese are formed by polyether-ether-ketone or derivatives thereof; Described tibia pad is made up of ultra-high molecular weight polyethylene.
2. full stress-strain macromolecular material ankle prosthesis according to claim 1, is characterized in that, for assembly type is connected between described tibia support prosthese with described tibia pad.
3. full stress-strain macromolecular material ankle prosthesis according to claim 1, is characterized in that, described tibia pad and described anklebone prosthese connect to form articular surface.
4. full stress-strain macromolecular material ankle prosthesis according to claim 1, is characterized in that, the near-end of described tibia support prosthese is crude or porous layer.
5. full stress-strain macromolecular material ankle prosthesis according to claim 1, is characterized in that, the far-end of described anklebone prosthese is crude or porous layer.
6. the full stress-strain macromolecular material ankle prosthesis according to claim 4 or 5, is characterized in that, described thickness that is crude or porous layer is 0.5-1.0 millimeter.
7. full stress-strain macromolecular material ankle prosthesis according to claim 6, is characterized in that, described crude or porous layer is made up of biocompatibility metal or its alloy.
8. full stress-strain macromolecular material ankle prosthesis according to claim 7, is characterized in that, described biocompatibility metal or its alloy comprise vitallium, titanium or titanium alloy, tantalum or tantalum alloy, rustless steel and zirconium-niobium alloy.
9. full stress-strain macromolecular material ankle prosthesis according to claim 8, is characterized in that, described biocompatibility metal or its alloy are titanium or titanium alloy.
10. full stress-strain macromolecular material ankle prosthesis according to claim 1, is characterized in that, described three outstanding ridges are triangularly arranged.
CN201510534398.1A 2015-08-27 2015-08-27 All-organic high molecular material ankle joint prosthesis Pending CN105030385A (en)

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PCT/CN2015/000732 WO2017031608A1 (en) 2015-08-27 2015-10-28 Fully organic macromolecular material ankle joint prosthesis

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107374788A (en) * 2017-08-29 2017-11-24 中国人民解放军第三军医大学 A kind of anatomical form fixed-bearing ankle prosthesis
CN111372540A (en) * 2017-08-29 2020-07-03 科润泰克株式会社 Artificial ankle joint talus element
CN111920551A (en) * 2020-07-28 2020-11-13 北京市春立正达医疗器械股份有限公司 Primary total ankle joint prosthesis
CN113456317A (en) * 2021-08-16 2021-10-01 北京市春立正达医疗器械股份有限公司 Integrated primary ankle joint tibial plateau prosthesis

Families Citing this family (1)

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CN109998739B (en) * 2019-05-16 2024-03-29 上海交通大学医学院附属第九人民医院 Combined artificial total ankle joint prosthesis

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CN204863564U (en) * 2015-08-27 2015-12-16 江苏奥康尼医疗科技发展有限公司 Full organic polymer material ankle joint prosthesis

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US6926739B1 (en) * 1999-05-13 2005-08-09 John J. O'Connor Prosthesis device for human articulations, in particular for the ankle articulation
CN101534751A (en) * 2006-09-15 2009-09-16 先锋外科技术公司 Joint arthroplasty devices having articulating members
CN101904777A (en) * 2009-06-04 2010-12-08 赫迈迪卡奥斯特尼克斯公司 Plastic surgery PAEK-is right-the polymeric support body
CN104411272A (en) * 2012-04-05 2015-03-11 英国巴奥米特保健有限公司 Prosthetic ankle components
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CN102920536A (en) * 2012-11-14 2013-02-13 黄国富 Buffer-type artificial ankle joint
CN103598936A (en) * 2013-10-21 2014-02-26 上海市第十人民医院 Combined tumor-type ankle joint prosthesis
CN204863564U (en) * 2015-08-27 2015-12-16 江苏奥康尼医疗科技发展有限公司 Full organic polymer material ankle joint prosthesis

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107374788A (en) * 2017-08-29 2017-11-24 中国人民解放军第三军医大学 A kind of anatomical form fixed-bearing ankle prosthesis
CN111372540A (en) * 2017-08-29 2020-07-03 科润泰克株式会社 Artificial ankle joint talus element
CN107374788B (en) * 2017-08-29 2023-08-29 中国人民解放军第三军医大学 Anatomic type ankle joint prosthesis with fixing pad
CN111920551A (en) * 2020-07-28 2020-11-13 北京市春立正达医疗器械股份有限公司 Primary total ankle joint prosthesis
CN113456317A (en) * 2021-08-16 2021-10-01 北京市春立正达医疗器械股份有限公司 Integrated primary ankle joint tibial plateau prosthesis

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