CN103479451A - Polyether-ether-ketone artificial spine intervertebral disc - Google Patents

Polyether-ether-ketone artificial spine intervertebral disc Download PDF

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Publication number
CN103479451A
CN103479451A CN201310467070.3A CN201310467070A CN103479451A CN 103479451 A CN103479451 A CN 103479451A CN 201310467070 A CN201310467070 A CN 201310467070A CN 103479451 A CN103479451 A CN 103479451A
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CN
China
Prior art keywords
end plate
ether
polyether
soleplate
intervertebral disc
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Pending
Application number
CN201310467070.3A
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Chinese (zh)
Inventor
张忠祥
孙守贵
吴大卫
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Beijing Bei Sida Bioisystech Co Ltd
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Beijing Bei Sida Bioisystech Co Ltd
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Publication date
Application filed by Beijing Bei Sida Bioisystech Co Ltd filed Critical Beijing Bei Sida Bioisystech Co Ltd
Priority to CN201310467070.3A priority Critical patent/CN103479451A/en
Publication of CN103479451A publication Critical patent/CN103479451A/en
Pending legal-status Critical Current

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    • 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
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • 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
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof

Abstract

A polyether-ether-ketone artificial spine intervertebral disc comprises an upper end plate, a lower end plate and a nucleus pulposus prosthesis arranged between the upper end plate and the lower end plate. The nucleus pulposus prosthesis is made of medical stainless steel or vitallium or biological ceramic and the upper end plate and the lower end plate are made of polyether-ether-ketone. The upper surface of the upper end plate and the lower surface of the lower end plate are respectively provided with a coarse surface and each coarse surface is formed according to the physical machining methods such as carving conducted by a carving machine and emery spraying. The upper end plate and the lower end plate are fixed to the spine in a fused mode, the nucleus pulposus prosthesis is placed between the upper end plate and the lower end plate and is also called a rotary center, three-dimensional rotary movement is achieved among the nucleus pulposus prosthesis, the upper end plate and the lower end plate, and therefore the function of motion of the normal spine intervertebral disc of a person can be provided. The upper end plate and the lower end plate which are made of the polyether-ether-ketone are good in biocompatibility and self-lubrication and quite resistant to abrasion. The nucleus pulposus prosthesis is good in mechanical performance and high in strength. The polyether-ether-ketone artificial spine intervertebral disc has the advantages of being simple in structure, good in biocompatibility, durable, and wide in adaptation disease range.

Description

A kind of polyether-ether-ketone artificial spine intervertebral disc
Technical field
The invention belongs to orthopedic fixation device tool technical field, be specifically related to a kind of polyether-ether-ketone artificial spine intervertebral disc be suitable under spinal trauma and pathological changes state.
Background technology
The spinal column artificial intervertebral disk is all made the spinal column artificial intervertebral disk with ultra-high molecular weight polyethylene (UHMWPE) and metallic combination both at home and abroad at present.Ultra-high molecular weight polyethylene (ultra high molecular weight polyethylene, UHMWPE) is most widely used general as the friction part material, and the most important target cell of UHMWPE wear particle is exactly macrophage.
Metal, polyethylene and polymethyl methacrylate are commonly called as the generation that lucite (PMMA) granule all causes macrophages infiltration and a large amount of inflammatory cytokines.Osteoclast is the apocyte come from the osteoclast precursor cell differentiation of mononuclear phagocyte system, is to cause the most important cell of bone resorption.Wear particle impels the osteoclast precursor cell very complicated to the process of differentiation of osteoclast, the direct effect that comprises wear particle with cause that with macrophage the environmental change of Periprosthetic cytokine is relevant.The macrophage granule that is worn constantly stimulates, and produces a large amount of proinflammatory disease media and enzyme of proteolysis.M-CSFs etc., promote the osteoclast precursor cell to differentiation of osteoclast, finally causes bone to dissolve.
And the antiwear property of UHMWPE is poor, in the service life that wearing and tearing have not only reduced prosthese, wear particle easily causes osteolysis, and aseptic loosening occurs, and will cause the consequence of second operation.
Summary of the invention
The present invention is exactly in order to solve above-mentioned the problems of the prior art, and a kind of polyether-ether-ketone artificial spine intervertebral disc is provided.
In order to achieve the above object, the present invention adopts following technical scheme:
Polyether-ether-ketone artificial spine intervertebral disc of the present invention, comprise soleplate, lower soleplate and be arranged on soleplate and lower soleplate between nucleus prosthesis; Form three-dimensional rotation between nucleus prosthesis and upper soleplate and lower soleplate and move, upper soleplate and lower soleplate are made by polyetheretherketonematerials materials, and the lower surface of the upper surface of upper soleplate and lower soleplate is provided with matsurface.
The material of described nucleus prosthesis is medical stainless steel, cobalt chrome molybdenum or bioceramic.
Described nucleus prosthesis is spherical ambipolar nucleus prosthesis or hemispheric monopole type nucleus prosthesis.
Described matsurface adopts the physical refining processess such as Carving Machining, corundum spray to be made.
The lower surface of the upper surface of described upper soleplate and lower soleplate all forms bossed sour jujube.
Advantage and good effect that the present invention has are:
Polyether-ether-ketone artificial spine intervertebral disc of the present invention, good biocompatibility, good mechanical property, self lubricity are good, and antiwear property is strong.Wear particle can not cause osteolysis, has reduced the probability of spinal column artificial intervertebral disk generation aseptic loosening, increases the service life of artificial disc after arthroplasty, avoids the consequence of patient's second operation.The nucleus prosthesis good mechanical property, intensity is high.The present invention has simple in structure, durable in use, the far-ranging characteristics of indication.Polyether-ether-ketone component materials outer surface is provided with matsurface, is beneficial to parts and human spine and merges.
The accompanying drawing explanation
Fig. 1 is the structural representation of polyether-ether-ketone artificial spine intervertebral disc of the present invention;
Fig. 2 is the structural representation of ambipolar nucleus prosthesis of the present invention;
Fig. 3 is the structural representation of monopole type nucleus prosthesis of the present invention.
Critical piece symbol description in accompanying drawing:
1. go up soleplate 2. nucleus prosthesis
3. descend soleplate 4. matsurfaces.
The specific embodiment
Below in conjunction with the drawings and specific embodiments, polyether-ether-ketone artificial spine intervertebral disc of the present invention is described further.Following each embodiment is not only limitation of the present invention for the present invention is described.
Fig. 1 is the structural representation of polyether-ether-ketone artificial spine intervertebral disc of the present invention; Fig. 2 is the structural representation of ambipolar nucleus prosthesis of the present invention; Fig. 3 is the structural representation of monopole type nucleus prosthesis of the present invention.As shown in Figure 1 to Figure 3, polyether-ether-ketone artificial spine intervertebral disc of the present invention, comprise soleplate 1, lower soleplate 3 and be arranged on soleplate 1 and lower soleplate 3 between nucleus prosthesis 2.Forming three-dimensional rotation between nucleus prosthesis 2 and upper soleplate 1 and lower soleplate 3 moves.Nucleus prosthesis 2 is called again rotary core, adopts medical stainless steel, cobalt chrome molybdenum or bioceramic material to make.Upper soleplate 1 and lower soleplate 3 are made by polyether-ether-ketone (peek) material.
The lower surface of the upper surface of upper soleplate 1 and lower soleplate 3 is provided with matsurface 4.Matsurface 4 adopts the physical refining processess such as Carving Machining, corundum sandblast to be made.Matsurface 4 can be grown upper phenomenon with the bone formation bone.
Upper soleplate 1 and lower soleplate 3 are fixed with spinal fusion, form three-dimensional rotation between nucleus prosthesis 2 and upper soleplate 1, lower soleplate 3 and move.Nucleus prosthesis 2 can be spherical ambipolar nucleus prosthesis or hemispheric monopole type nucleus prosthesis.The monopole type nucleus prosthesis is that an end and upper soleplate (or lower soleplate) are fixing, and the other end and lower soleplate (or upper soleplate) form three-dimensional rotation and move.Ambipolar nucleus prosthesis is that move with upper soleplate and lower soleplate formation three-dimensional rotation respectively at two ends, there are two moving points, monopole type nucleus prosthesis and upper soleplate, that lower soleplate is used in combination its stability is stronger, ambipolar nucleus prosthesis and upper soleplate, that lower soleplate is used in combination its motility is stronger, is the movable function that human body provides normal spinal column intervertebral disc.
The surface of upper soleplate 1 of the present invention and lower soleplate 3 also can not arrange coating or matsurface, can realize equally the function of spinal column intervertebral disc.
The lower surface of the upper surface of upper soleplate 1 and lower soleplate 3 all forms bossed sour jujube, and the effect of sour jujube is to thrust in the human spine to improve its implantation stability.
The present invention adopts polyether-ether-ketone to make soleplate and lower soleplate.Polyether-ether-ketone (peek) has good biocompatibility and stable chemical characteristic, the various countries scholars are studied the biocompatibility of PEEK, by cell in vitro cultivate, the method such as animal body is implanted into measures indexs such as the cytotoxicity of material, cell proliferation rate, mutagenicity, adhesion, cell biological functions, a series of PEEK of studies have shown that have good biocompatibility and stable chemical characteristic.The Volume erosion rate of PEEK material is about 1/2 of UHMWPE.
PEEK is the plastics that toughness and rigidity have both and average out, and mechanical property is good, polyether-ether-ketone PEEK good biocompatibility, and self lubricity is good, and antiwear property is strong, and wear particle can not cause osteolysis.Polyether-ether-ketone PEEK makes upper and lower soleplate and has eliminated the phenomenon that causes human metalloproteinase allergy because of metal material contact skeleton, has solved the rejection problem of human body to metal, makes it implant crowd's expanded range.Particularly importantly nontoxic, the light weight, corrosion-resistant of PEEK is and the immediate material of skeleton therefore to adopt PEEK to replace the metallic body skeleton that makes children.Polyether-ether-ketone PEEK can stand 3000 times the circulation autoclaving under 134 ℃, and this characteristic can meet the sterilizing requirement, with it, can manufacture the various medical apparatus and instruments that need high-temperature steam sterilization.The anti-high irradiation of radioresistance very capable, surpassed the best polystyrene of radioresistance in the resins for universal use.The high-performance that still can keep good insulating capacity in the time of can making the γ irradiation dose and reach 1100Mrad, so can do the radiation sterilization product.Therefore polyetheretherketonematerials materials is made into soleplate and lower soleplate, and this product antiwear property is strong, good biocompatibility, and transplanting scope is extensive, and sterilization method is more, sterilizing facility during use.
Nucleus prosthesis adopts the materials such as medical stainless steel, cobalt chrome molybdenum or bioceramic to make.Medical stainless steel intensity is high, has stronger mechanical performance, the corrosion resistance excellence, and biocompatibility is relatively poor, but with low cost, is applicable to using than poverty-stricken area.
The Co-Cr-Mo alloy is replaced the trunk of prosthese connector mainly for the manufacture of joint, bear heavy load, as knee joint and hip joint etc.This alloy has very strong corrosion stability, and Co-Cr-Mo alloy (vitallium) has very high fatigue strength and ultimate tensile strength, after implanting for a long time, and also seldom can fracture.
Bioceramic not only has the characteristic that plastic stainless-steel has, and has hydrophilic, can show good affinity with biological tissues such as cells.Bioceramic, except for measurement, diagnoses and treatment etc., is mainly the substitute material as biological hard tissue, can be used for the aspects such as orthopaedics, plastic surgery, dentistry, oral surgery, cardiovascular surgery, external coat, department of otorhinolaryngology and general surgery.The biological hard tissue substitute material has body bone, animal bone, develops into afterwards and adopts rustless steel and plastics, and because these biomaterials are used in organism, rustless steel exists dissolved, corrosion and fatigue problem, the poor and low problem of intensity of plastics existence and stability.Therefore bioceramic has vast potential for future development, and countries in the world have been developed bioceramic material in succession at present.Bio-inert ceramic mainly refers to stable chemical performance, the ceramic material that biocompatibility is good.The structure of this class ceramic material is all more stable, and the bonding force in molecule is stronger, and all has higher mechanical strength.Wearability and chemical stability.
The contacted surface of polyether-ether-ketone (peek) parts and vertebral body adopts matsurface, and this surface can stimulate the quick long bone in this position and have no side effect, and all brings good Gospel can to different patients.

Claims (9)

1. a polyether-ether-ketone artificial spine intervertebral disc, comprise soleplate (1), lower soleplate (3) and be arranged on soleplate (1) and lower soleplate (3) between nucleus prosthesis (2); Forming three-dimensional rotation between nucleus prosthesis (2) and upper soleplate (1) and lower soleplate (3) moves, it is characterized in that: upper soleplate (1) and lower soleplate (3) are made by polyetheretherketonematerials materials, and the lower surface of the upper surface of upper soleplate (1) and lower soleplate (3) is provided with matsurface (4).
2. polyether-ether-ketone artificial spine intervertebral disc according to claim 1, it is characterized in that: the material of nucleus prosthesis (2) is medical stainless steel.
3. polyether-ether-ketone artificial spine intervertebral disc according to claim 1, it is characterized in that: the material of nucleus prosthesis (2) is the cobalt chrome molybdenum.
4. polyether-ether-ketone artificial spine intervertebral disc according to claim 1, it is characterized in that: the material of nucleus prosthesis (2) is bioceramic.
According to claim 1 to the described polyether-ether-ketone artificial spine of any one in claim 4 intervertebral disc, it is characterized in that: nucleus prosthesis (2) is spherical ambipolar nucleus prosthesis.
According to claim 1 to the described polyether-ether-ketone artificial spine of any one in claim 4 intervertebral disc, it is characterized in that: nucleus prosthesis (2) is hemispheric monopole type nucleus prosthesis.
7. polyether-ether-ketone artificial spine intervertebral disc according to claim 1 is characterized in that: matsurface (4) adopts the physical refining processes of Carving Machining to be made.
8. polyether-ether-ketone artificial spine intervertebral disc according to claim 1 is characterized in that: matsurface (4) adopts the physical refining processes of corundum spray to be made.
9. polyether-ether-ketone artificial spine intervertebral disc according to claim 1, is characterized in that: go up the upper surface of soleplate (1) and the lower surface of lower soleplate (3) and all form bossed sour jujube.
CN201310467070.3A 2013-10-10 2013-10-10 Polyether-ether-ketone artificial spine intervertebral disc Pending CN103479451A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015184696A1 (en) * 2014-06-03 2015-12-10 深圳兰度生物材料有限公司 Artificial intervertebral disc and preparation method thereof
US9408714B1 (en) 2015-06-12 2016-08-09 Amendia, Inc. Artificial disc
CN109475665A (en) * 2016-06-21 2019-03-15 沙特基础工业全球技术公司 Backbone rack and its manufacturing method
CN111317597A (en) * 2020-02-24 2020-06-23 汕头大学 3D printed bionic artificial cervical intervertebral joint
CN115923121A (en) * 2022-12-05 2023-04-07 武汉大学 3D prints from perception dummy cervical vertebra

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015184696A1 (en) * 2014-06-03 2015-12-10 深圳兰度生物材料有限公司 Artificial intervertebral disc and preparation method thereof
US9408714B1 (en) 2015-06-12 2016-08-09 Amendia, Inc. Artificial disc
CN109475665A (en) * 2016-06-21 2019-03-15 沙特基础工业全球技术公司 Backbone rack and its manufacturing method
CN111317597A (en) * 2020-02-24 2020-06-23 汕头大学 3D printed bionic artificial cervical intervertebral joint
CN111317597B (en) * 2020-02-24 2022-03-18 汕头大学 3D printed bionic artificial cervical intervertebral joint
CN115923121A (en) * 2022-12-05 2023-04-07 武汉大学 3D prints from perception dummy cervical vertebra
CN115923121B (en) * 2022-12-05 2024-02-27 武汉大学 3D prints from perception dummy cervical vertebra

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Application publication date: 20140101