CN106726022A - A kind of artificial intervertebral disk and its forming method without interface friction - Google Patents

A kind of artificial intervertebral disk and its forming method without interface friction Download PDF

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Publication number
CN106726022A
CN106726022A CN201710096704.7A CN201710096704A CN106726022A CN 106726022 A CN106726022 A CN 106726022A CN 201710096704 A CN201710096704 A CN 201710096704A CN 106726022 A CN106726022 A CN 106726022A
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China
Prior art keywords
rigid endplate
elastic
nucleus pulposus
endplate
polyurethane material
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CN201710096704.7A
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Chinese (zh)
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CN106726022B (en
Inventor
孟阳
冯巧芳
姜秀娟
张立群
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Beijing University of Chemical Technology
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Wuxi Baolai Fu Medical Instrument Ltd Co
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Priority to CN201710096704.7A priority Critical patent/CN106726022B/en
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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
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/32—Phosphorus-containing materials, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C69/00—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore
    • B29C69/02—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore of moulding techniques only
    • 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
    • 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
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30016—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
    • 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
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • A61F2002/443—Intervertebral or spinal discs, e.g. resilient made of articulated components having two transversal endplates and at least one intermediate component
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
    • A61F2310/00407—Coating made of titanium or of Ti-based alloys
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Abstract

The present invention relates to a kind of artificial intervertebral disk and its forming method without interface friction, it is made up of upper rigid endplate, lower rigid endplate, the elastic nucleus pulposus being arranged between upper rigid endplate, lower rigid endplate and the film body being arranged on the outside of elastic nucleus pulposus；Elastic nucleus pulposus is constituted using the polyurethane material of two or more dual extension-compression modulus, and the polyurethane material of dual extension-compression modulus is connected as a single entity.Rigid endplate polyurethane material product is prepared during shaping first and the last polyurethane material that will inject low elastic modulus in centre of lower rigid endplate polyurethane material product realizes the connection of upper and lower product.Product of the present invention is integral type structure, by the elastic deformation of elastic nucleus pulposus during by load, realizes artificial intervertebral disk physiological activity in all directions.

Description

A kind of artificial intervertebral disk and its forming method without interface friction
Technical field
The present invention relates to a kind of artificial intervertebral disk and its forming method without interface friction, belong to medical embedded property orthopaedics doctor Treat technique with the apparatus field.
Background technology
Interverbebral disc is the chief component of spinal motion segment, and its Main Function is：Produce adjacent two interpyramidal spy Different restriction activity, absorbs and buffering concussion by the elasticity of nucleus pulposus and the special tectonic of fibrous ring.It is false from first generation interverbebral disc Body --- after ball articular prosthesis emerge, ball-and-socket prosthese, arch prosthese, Articular disc prosthesis and hard soleplate-hard marrow are developed successively Core prosthese etc., can preferably meet the prosthese of body biomechanicses requirement, however these prostheses abandon substantially mostly it is right The requirement of elasticity, and concentrate on motion reservation aspect.Separately there are some more using the elasticity design prosthese of silicones, elastic piston The elasticity for focusing on interverbebral disc, rather than the activity on motor function, especially horizontal plane.
Have more than ten kind intervertebral disk prosthesis listings in the world at present or enter clinical stage through FDA approvals, and at home, still Intervertebral disk prosthesis launch without independent research.At present, the main total spinal disc replacement prosthesis type of in the market includes three kinds： Three prostheses of functional component composition（A types）, two function ingredients compositions prosthese（Type B）The vacation constituted with One function component Body（C-type）.Wherein A types prosthese and Type B prosthese are all metal-polymer or metal-metal and other stiff members according to ball mortar The friction-type artificial intervertebral disk of principle design, retains five motions in free degree direction.On the one hand, this hard support ball-and-socket knot Structure, without elasticity, cervical vertebra can not be well protected when being shaken；On the other hand, after Using prosthesis, used in long-time In can produce abrasive dust because of friction, the tissue to surrounding impact.C-type prosthese is free of articular surface, mainly by nucleus material Elastic deformation realizes activity, and this kind of prosthese further comprises load attenuation function, but still exist between nucleus pulposus and soleplate big The interface of amount, a kind of c-type prosthese as disclosed in patent US8377138B2, it, will by connected modes such as traditional mechanical interlocks Elastomer nucleus material is fixedly connected with rigid endplate, although realize certain connection, but elastomer nucleus material with Metal rigidity soleplate meeting Presence of an interface problem, and can also there is displacement interface between endplate assemblies, implant makes for a long time The problems such as material abrasion, heat may still being produced because rubbing repeatedly during, are come off.The A of patent CN 101836907 and patent Two kinds of artificial intervertebral disks of monoblock type disclosed in the U of CN 202027749, are connected by integral type, are reduced to a certain extent The frictional interface of elastomer and rigid endplate material, but its overall structure is mainly by rigid endplate, elastic nucleus pulposus and other phases Close part subsequently to assemble to be formed, elastomeric core still suffers from interface with rigid endplate.Additionally, due to rigid endplate and elastic nucleus pulposus Material has larger difference to the DEFORMATION RESPONSE of load, during long-term use, also can be in rigid endplate and elastomer nucleus pulposus material New interface is produced between material.During human body long time running is implanted into, one is still had between rigid endplate and elastomer nucleus pulposus A little Interface Problems, the fastness and stability of the assembling of each part also have certain influence.
The content of the invention
The invention aims to solve the above problems, there is provided a kind of simple structure, compact to design rubs without interface The artificial intervertebral disk and its forming method of wiping.
The present invention is adopted the following technical scheme that：A kind of artificial intervertebral disk without interface friction, by upper rigid endplate, lower rigidity Soleplate, the elastic nucleus pulposus being arranged between rigid endplate, lower rigid endplate and the film body being arranged on the outside of elastic nucleus pulposus are constituted； The elastic nucleus pulposus is constituted using the polyurethane material of two or more dual extension-compression modulus, the poly- ammonia of dual extension-compression modulus Ester material is connected as a single entity, and the elastic nucleus pulposus is with upper rigid endplate, lower rigid endplate integral molding without frictional interface.
Further, the upper end both sides of the elastic nucleus pulposus are respectively arranged with the first extension and the second extension, described The lower end both sides of elastic nucleus pulposus are respectively arranged with the 3rd extension and the 4th extension, and the left and right two ends of the elastic nucleus pulposus are in arc Shape indent, is provided with the upper groove matched with the first extension and the second extension in the upper rigid endplate, described lower firm Property soleplate on be provided with the low groove matched with the 3rd extension and the 4th extension, the top and bottom difference of the film body It is fastened in rigid endplate, lower rigid endplate.
Further, the elastic nucleus pulposus contacts the elastic modelling quantity of the material of side with upper rigid endplate, lower rigid endplate Higher than the elastic modelling quantity of elastic nucleus pulposus center material.
Further, the surface of the upper rigid endplate and lower rigid endplate is provided with several stable teeth, described firm The surface of property soleplate and lower rigid endplate is provided with titanium coating or hydroxyapatite coating layer.
Further, it is respectively arranged with the elastic nucleus pulposus and upper rigid endplate, the contact surface of lower rigid endplate some Individual wavy raised or several rectangular preiections.
Further, be respectively provided with the elastic nucleus pulposus and upper rigid endplate, the contact surface of lower rigid endplate it is fluted, The groove is rectangular channel, T-slot or funnel type groove.
A kind of forming method of the artificial intervertebral disk without interface friction, comprises the following steps：
（1）Upper rigid endplate, lower rigid endplate are placed in mould, are the polyurethane material point of 20 ~ 500MPa by elastic modelling quantity Die for molding is not injected into, rigid endplate-polyurethane material product and lower rigid endplate-polyurethane material system is respectively obtained Part；
（2）100 ~ 240 DEG C of forming temperature of control, repeat step（1）In the upper rigid endplate-polyurethane material product for preparing It is several less than step with being implanted sequentially on lower rigid endplate-polyurethane material product（1）The polyurethane material of Elastic Modulus Obtain the different piece of elastic nucleus pulposus；
（3）By step（2）Upper rigid endplate-polyurethane material the product and lower rigid endplate-polyurethane material product for obtaining are put In mould, in centre, injection is less than step（2）In the polyurethane material of elastic modelling quantity realize upper rigid endplate-polyurethane material The connection of material product and lower rigid endplate-polyurethane material product, prepares artificial intervertebral disk.
The invention has the advantages that：（1）Elastic nucleus pulposus is made up of different grades of many hardened materials, is gradient function material Material, the polyurethane comprising two or more elastic modelling quantity, the upper and lower two-side elastic modulus contacted with rigid endplate is higher than The elastic modelling quantity of center section elastomer, is prevented effectively from and is produced because of modulus difference larger between rigid endplate and elastic nucleus pulposus Interfacial separation；（2）Elastic nucleus pulposus is combined with rigid endplate close and firm, does not exist interface friction when movable, is prevented effectively from plant Because of side reaction caused by friction chip after entering；（3）Whole cervical artificial disc elasticity is non-hard support slide construction, by elasticity The elastic deformation of nucleus pulposus effectively realize cervical artificial disc rotating, the activity bending and stretching, translate three-dimensional six-freedom degree space, more The physiological property of the nearly human normal disk of adjunction；（4）Rigid endplate surface is designed with stabilization tooth and titanium coating or hydroxyapatite Coating structure, effectively the Initial stability of cervical artificial disc and the Integrated implant in later stage are realized after implantation；（5）Elastic nucleus pulposus outside One layer of elastic protective film is provided with, can be grown into effectively preventing human body soft tissue.
Brief description of the drawings
Fig. 1 is structural representation of the invention.
Fig. 2 is the schematic diagram of elastic core structure of the invention.
Fig. 3 is the schematic diagram before and after elastic intramarrow nuclear deformation of the invention.
Fig. 4 is rigid endplate of the invention and elastic nucleus pulposus contact interface structure chart.
Fig. 5 is the forming method schematic diagram of artificial intervertebral disk in the present invention.
Reference：Upper rigid endplate 1, lower rigid endplate 2, elastic nucleus pulposus 3, the first extension 3-1, the second extension 3- 2nd, the 3rd extension 3-3, the 4th extension 3-4, film body 4, upper groove 5, low groove 6.
Specific embodiment
Below in conjunction with accompanying drawing, the invention will be further described.
As shown in figure 1, a kind of artificial intervertebral disk without interface friction, by upper rigid endplate 1, lower rigid endplate 2, is arranged at Elastic nucleus pulposus 3 between upper rigid endplate 1, lower rigid endplate 2 and it is arranged at the film body 4 in the outside of elastic nucleus pulposus 3 and constitutes；Elastic intramarrow Core 3 is constituted using the polyurethane material of two or more dual extension-compression modulus, and the polyurethane material of dual extension-compression modulus connects It is integrated, the upper end both sides of elastic nucleus pulposus 3 are respectively arranged with the first extension 3-1 and the second extension 3-2, elastic nucleus pulposus 3 Lower end both sides are respectively arranged with the 3rd extension 3-3 and the 4th extension 3-4, the curved indent in left and right two ends of elastic nucleus pulposus 3, The upper groove 5 matched with the first extension 3-1 and the second extension 3-2, lower rigid endplate 2 are provided with upper rigid endplate 1 On be provided with the low groove 6 matched with the 3rd extension 3-3 and the 4th extension 3-4, elastic nucleus pulposus 3 and upper rigid endplate 1, The lower integral molding of rigid endplate 2 does not exist frictional interface, the top and bottom of film body 4 be fastened on respectively rigid endplate 1, under In rigid endplate 2.The surface of upper rigid endplate 1 and lower rigid endplate 2 is provided with several stable teeth, upper rigid endplate and it is lower just The surface of property soleplate is provided with titanium coating or hydroxyapatite coating layer.This kind is designed to that artificial intervertebral disk implantation people is effectively ensured After body, with preferable Initial stability and osseointegration character.
Fig. 2 is the schematic diagram of gradient type elasticity core structure in the present invention.The modulus of elastic nucleus pulposus 3 is presented uneven point Cloth, distribution pattern can be by the stepped change of material modulus near rigid endplate to nucleus pulposus center（2a、2b、2c）, or by Rigid endplate to nucleus pulposus center material modulus gradual change type changes（2d）.
When artificial intervertebral disk is subject to external force load generation activity, activity mainly by elastic nucleus pulposus Elastic Modulus compared with The deformation of the polyurethane material of fraction is realized.Fig. 3 is the signal before and after the elastic intramarrow nuclear deformation of preferred embodiment in the present invention Figure.State when 3a is artificial intervertebral disk not loaded, 3b is the elastic nucleus pulposus when artificial intervertebral disk is subject to load generation activity The less part of elasticity modulus of materials（Intermediate layer）Moderate finite deformation is produced, is produced from the of a relatively high part of the modulus adjacent with intermediate layer The less deformation of life, the part modulus being in contact with rigid endplate is higher, is nearly free from deformation, so as between rigid endplate Frictional interface will not be formed because deforming excessive generation interfacial separation.
Fig. 4 is upper and lower rigid endplate in the present invention and elastic nucleus pulposus contact interface structure chart.
It is wavy several to be respectively arranged with elastic nucleus pulposus 3 and upper rigid endplate 1, the contact surface of lower rigid endplate 2 It is raised（4a）Or several rectangular preiections（4b）.
Elastic nucleus pulposus 3 is arc-shaped with the contact surface of upper rigid endplate 1, lower rigid endplate 2（4c）.
It is respectively provided with fluted on elastic nucleus pulposus 3 and upper rigid endplate 1, the contact surface of lower rigid endplate 2, groove is rectangle Groove（4d）, T-slot（4f）Or funnel type groove（4e）.
Fig. 5 is two kinds of schematic diagrames of forming method of artificial intervertebral disk in the present invention.From 5a-5d, step is：
（1）Upper rigid endplate, lower rigid endplate are placed in mould, are the polyurethane material point of 20 ~ 500MPa by elastic modelling quantity Die for molding is not injected into, rigid endplate-polyurethane material product and lower rigid endplate-polyurethane material system is respectively obtained Part；
（2）100 ~ 240 DEG C of forming temperature of control, repeat step（1）In the upper rigid endplate-polyurethane material product for preparing It is several less than step with being implanted sequentially on lower rigid endplate-polyurethane material product（1）The polyurethane material of Elastic Modulus Obtain the different piece of elastic nucleus pulposus；
（3）By step（2）Upper rigid endplate-polyurethane material the product and lower rigid endplate-polyurethane material product for obtaining are put In mould, in centre, injection is less than step（2）In the polyurethane material of elastic modelling quantity realize upper rigid endplate-polyurethane material The connection of material product and lower rigid endplate-polyurethane material product, prepares artificial intervertebral disk.

Claims (7)

1. a kind of artificial intervertebral disk without interface friction, it is characterised in that：By upper rigid endplate（1）, lower rigid endplate（2）, set It is placed in rigid endplate（1）, lower rigid endplate（2）Between elastic nucleus pulposus（3）And it is arranged at elastic nucleus pulposus（3）The film body in outside （4）Constitute；The elastic nucleus pulposus（3）Constituted using the polyurethane material of two or more dual extension-compression modulus, different bullets The polyurethane material of property modulus is connected as a single entity, the elastic nucleus pulposus（3）With upper rigid endplate（1）, lower rigid endplate（2）Integral type Shaping, without frictional interface.
2. the artificial intervertebral disk without interface friction as claimed in claim 1, it is characterised in that：The elastic nucleus pulposus（3）It is upper End both sides are respectively arranged with the first extension（3-1）With the second extension（3-2）, the elastic nucleus pulposus（3）Lower end both sides point The 3rd extension is not provided with（3-3）With the 4th extension（3-4）, the elastic nucleus pulposus（3）The curved indent in left and right two ends, The upper rigid endplate（1）On be provided with and the first extension（3-1）With the second extension（3-2）The upper groove for matching（5）, The lower rigid endplate（2）On be provided with and the 3rd extension（3-3）With the 4th extension（3-4）The low groove for matching（6）, The film body（4）Top and bottom be fastened on rigid endplate respectively（1）, lower rigid endplate（2）On.
3. the artificial intervertebral disk without interface friction as claimed in claim 1, it is characterised in that：The elastic nucleus pulposus（3）With it is upper Rigid endplate（1）, lower rigid endplate（2）The elastic modelling quantity for contacting the material of side is higher than the elasticity of elastic nucleus pulposus center material Modulus.
4. the artificial intervertebral disk without interface friction as claimed in claim 1, it is characterised in that：The upper rigid endplate（1）With Lower rigid endplate（2）Surface be provided with several stable teeth, the upper rigid endplate（1）With lower rigid endplate（2）Surface It is provided with titanium coating or hydroxyapatite coating layer.
5. the artificial intervertebral disk without interface friction as claimed in claim 2, it is characterised in that：The elastic nucleus pulposus（3）With it is upper Rigid endplate（1）, lower rigid endplate（2）Contact surface on to be respectively arranged with several wavy raised or several rectangles convex Rise.
6. the artificial intervertebral disk without interfacial film material as claimed in claim 2, it is characterised in that：The elastic nucleus pulposus（3）With it is upper Rigid endplate（1）, lower rigid endplate（2）Contact surface on be respectively provided with it is fluted, the groove be rectangular channel, T-slot or leakage Bucket type groove.
7. the forming method of the artificial intervertebral disk without interface friction described in claim 1, it is characterised in that：Including following step Suddenly：
（1）By upper rigid endplate（1）, lower rigid endplate（2）It is placed in mould, is the polyurethane of 20 ~ 500MPa by elastic modelling quantity Material is injected separately into die for molding, respectively obtains rigid endplate-polyurethane material product and lower rigid endplate-polyurethane Material；
（2）100 ~ 240 DEG C of forming temperature of control, repeat step（1）In the upper rigid endplate-polyurethane material product for preparing It is several less than step with being implanted sequentially on lower rigid endplate-polyurethane material product（1）The polyurethane material of Elastic Modulus Obtain the different piece of elastic nucleus pulposus；
（3）By step（2）Upper rigid endplate-polyurethane material the product and lower rigid endplate-polyurethane material product for obtaining are put In mould, in centre, injection is less than step（2）In the polyurethane material of elastic modelling quantity realize upper rigid endplate-polyurethane material The connection of material product and lower rigid endplate-polyurethane material product, prepares artificial intervertebral disk.
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CN111920554A (en) * 2018-06-12 2020-11-13 深圳市立心科学有限公司 Intervertebral fusion cage adapting to bone shape
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