CN106726022B - A kind of artificial intervertebral disk and its forming method of no interface friction - Google Patents
A kind of artificial intervertebral disk and its forming method of no interface friction Download PDFInfo
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- CN106726022B CN106726022B CN201710096704.7A CN201710096704A CN106726022B CN 106726022 B CN106726022 B CN 106726022B CN 201710096704 A CN201710096704 A CN 201710096704A CN 106726022 B CN106726022 B CN 106726022B
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- rigid endplate
- nucleus pulposus
- endplate
- polyurethane material
- elastic
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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)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Vascular Medicine (AREA)
- Neurology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Dermatology (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Prostheses (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Mechanical Engineering (AREA)
- Materials For Medical Uses (AREA)
Abstract
The present invention relates to the artificial intervertebral disks and its forming method of a kind of no interface friction, are made of upper rigid endplate, lower rigid endplate, the elastic nucleus pulposus being set between upper rigid endplate, lower rigid endplate and the membrane body being set on the outside of elastic nucleus pulposus;Elastic nucleus pulposus is formed using the polyurethane material of two or more dual extension-compression modulus, and the polyurethane material of dual extension-compression modulus is linked together.The connection that rigid endplate-polyurethane material product and lower rigid endplate-polyurethane material product will finally realize product up and down in the polyurethane material of intermediate injection low elastic modulus is prepared when molding first.Product of the present invention is an integral structure, and by the flexible deformation of elastic nucleus pulposus when by load, realizes the physiological activity of artificial intervertebral disk in all directions.
Description
Technical field
The present invention relates to the artificial intervertebral disks and its forming method of a kind of no interface friction, belong to medical embedded property orthopaedics doctor
Treat equipment technology field.
Background technique
Interverbebral disc is the chief component of spinal motion segment, main function are as follows: generates adjacent two interpyramidal spy
Different restriction activity absorbs by the elasticity of nucleus pulposus and the special tectonic of fibrous ring and buffering is shaken.It is false from first generation interverbebral disc
Body --- after ball articular prosthesis emerges, ball-and-socket prosthese, arch prosthese, Articular disc prosthesis and the hard marrow of hard soleplate-are developed successively
Core prosthese etc., can preferably meet the prosthese of body biomechanics requirement, however these prostheses abandon pair substantially mostly
The requirement of elasticity, and concentrate on movement and retain aspect.Separately there are some elasticity design prostheses using silicone resin, elastic piston more
The elasticity for focusing on interverbebral disc, rather than the activity on motor function, especially horizontal plane.
Have the listing of more than ten intervertebral disk prosthesis in the world at present or enters clinical stage through FDA approval, and at home, still
Intervertebral disk prosthesis launch without independent research.Currently, main total spinal disc replacement prosthesis type includes three kinds in the market:
The vacation of prosthese (Type B) and function ingredients composition that the prosthese (A type) of three functional components composition, two function ingredients form
Body (c-type).Wherein A type 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 the movement of five freedom degree directions.On the one hand, this hard support ball-and-socket knot
Structure does not have elasticity, not can be well protected cervical vertebra when being shaken;On the other hand, it after Using prosthesis, is used in long-time
In can because friction generate abrasive dust, the tissue of surrounding is impacted.C-type prosthese is free of articular surface, mainly passes through nucleus material
Flexible deformation realizes activity, and this kind of prosthese further comprises load attenuation function, but still exists between nucleus pulposus and soleplate big
The interface of amount, a kind of c-type prosthese as disclosed in patent US8377138B2 will by connection types such as traditional mechanical interlocks
Elastomer nucleus material is fixedly connected with rigid endplate, although realizing certain connection, elastomer nucleus material with
Metal rigidity soleplate can have interface problem, and can also have displacement interface between endplate assemblies, and implant makes for a long time
With still possibility in the process because of the problems such as friction generates material abrasion, heat, falls off repeatedly.101836907 A of patent CN and patent
The artificial intervertebral disk of two kinds of monoblock types disclosed in 202027749 U of CN, is connected by integral type, is 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
It closes the subsequent assembling of component to be formed, there are still interfaces for elastomeric core and rigid endplate.Additionally, due to rigid endplate and elastic nucleus pulposus
Material has larger difference to the DEFORMATION RESPONSE of load, in the long-term use, also can be in rigid endplate and elastomer nucleus pulposus material
New interface is generated between material.During being implanted into human body long time running, one is still had between rigid endplate and elastomer nucleus pulposus
A little Interface Problems, the fastness and stability of the assembly of each component also have certain influence.
Summary of the invention
The purpose of the present invention is to solve the above problem, provide that a kind of structure is simple, and no interface compact to design is rubbed
The artificial intervertebral disk and its forming method of wiping.
The present invention adopts the following technical scheme: a kind of artificial intervertebral disk of no interface friction, by upper rigid endplate, lower rigidity
Soleplate, the elastic nucleus pulposus being set between rigid endplate, lower rigid endplate and the membrane body being set on the outside of elastic nucleus pulposus are constituted;
The elasticity nucleus pulposus is formed using the polyurethane material of two or more dual extension-compression modulus, the poly- ammonia of dual extension-compression modulus
Ester material is linked together, and the elasticity nucleus pulposus and upper rigid endplate, lower rigid endplate integral molding are without frictional interface.
Further, the upper end two sides of the elastic nucleus pulposus are respectively arranged with the first extension and the second extension, described
The lower end two sides of elastic nucleus pulposus are respectively arranged with third extension and the 4th extension, and the left and right ends of the elasticity nucleus pulposus are in arc
Shape indent, is provided with the upper groove to match with the first extension and the second extension in the upper rigid endplate, it is described it is lower just
Property soleplate on be provided with the lower groove to match with third extension and the 4th extension, the top and bottom difference of the membrane body
It is fastened on rigid endplate, in lower rigid endplate.
Further, the elastic nucleus pulposus and upper rigid endplate, lower rigid endplate contact the elasticity modulus of the material of side
Higher than the elasticity modulus of material at elastic nucleus pulposus center.
Further, the surface of the upper rigid endplate and lower rigid endplate is provided with several stable teeth, described rigid
The surface of property soleplate and lower rigid endplate is provided with titanium coating or hydroxyapatite coating layer.
Further, it is respectively arranged on the contact surface of the elastic nucleus pulposus and upper rigid endplate, lower rigid endplate several
A wavy protrusion or several rectangular preiections.
Further, be respectively set on the contact surface of the elastic nucleus pulposus and upper rigid endplate, 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 of no interface friction, includes the following steps:
(1) upper rigid endplate, lower rigid endplate are placed in mold, the polyurethane material for being 20 ~ 500MPa by elasticity modulus
Material is injected separately into die for molding, respectively obtains rigid endplate-polyurethane material product and lower rigid endplate-polyurethane material
Expect product;
(2) 100 ~ 240 DEG C of forming temperature are controlled, repeats step (1) in the upper rigid endplate-polyurethane material being prepared
The several polyurethane lower than step (1) Elastic Modulus is implanted sequentially on product and lower rigid endplate-polyurethane material product
Material obtains the different piece of elastic nucleus pulposus;
(3) the upper rigid endplate-polyurethane material product obtained step (2) and lower rigid endplate-polyurethane material system
Part is placed in mold, realizes the upper poly- ammonia of rigid endplate-lower than the polyurethane material of the elasticity modulus in step (2) in intermediate injection
Ester material product and the connection of lower rigid endplate-polyurethane material product, are prepared artificial intervertebral disk.
The present invention has the advantage that (1) elasticity nucleus pulposus is made of different grades of more hardened materials, it is gradient function material
Material, the polyurethane comprising two or more elasticity modulus, the upper and lower two-side elastic modulus contacted with rigid endplate are higher than
The elasticity modulus of middle section elastomer, effectively avoid because between rigid endplate and elastic nucleus pulposus biggish modulus difference due to generate
Interfacial separation;(2) elastic nucleus pulposus is not present interface friction, effectively avoids planting in conjunction with rigid endplate close and firm when movable
After entering because friction clast caused by side reaction;(3) entire cervical artificial disc elasticity is non-hard support slide construction, passes through elasticity
The flexible deformation of nucleus pulposus effectively realize cervical artificial disc in the activity for rotating, 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 design has stable tooth and titanium coating or hydroxyapatite
Coating structure effectively realizes the Initial stability of cervical artificial disc and the Integrated implant in later period after implantation;(5) on the outside of elastic nucleus pulposus
It is provided with one layer of elastic protective film, is grown into while human body soft tissue can be effectively prevent.
Detailed description of the invention
Fig. 1 is the structural diagram of the present 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.
Appended drawing reference: upper rigid endplate 1, lower rigid endplate 2, elastic nucleus pulposus 3, the first extension 3-1, the second extension 3-
2, third extension 3-3, the 4th extension 3-4, membrane body 4, upper groove 5, lower groove 6.
Specific embodiment
Below in conjunction with attached drawing, the invention will be further described.
As shown in Figure 1, a kind of artificial intervertebral disk of no interface friction, by upper rigid endplate 1, lower rigid endplate 2, is set to
Elastic nucleus pulposus 3 between upper rigid endplate 1, lower rigid endplate 2 and the membrane body 4 for being set to elastic 3 outside of nucleus pulposus are constituted;Elastic intramarrow
Core 3 is formed 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 two 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 two sides are respectively arranged with third extension 3-3 and the 4th extension 3-4, the arc-shaped indent in left and right ends of elastic nucleus pulposus 3,
The upper groove 5 to match with the first extension 3-1 and the second extension 3-2, lower rigid endplate 2 are provided in upper rigid endplate 1
On be provided with the lower groove 6 to match with third extension 3-3 and the 4th extension 3-4, elastic nucleus pulposus 3 and upper rigid endplate 1,
Lower 2 integral molding of rigid endplate be not present frictional interface, the top and bottom of membrane 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 design can effectively ensure that artificial intervertebral disk is implanted into people
After body, there is 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, which can be, changes (2a, 2b, 2c) by the material modulus step type close to rigid endplate to nucleus pulposus center, or by
Rigid endplate to nucleus pulposus center material modulus gradual change type changes (2d).
When artificial intervertebral disk is by 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 in the present invention before and after the elastic intramarrow nuclear deformation of preferred embodiment
Figure.3a is state when artificial intervertebral disk is not loaded, and 3b is the elastic nucleus pulposus when artificial intervertebral disk is by load generation activity
The lesser part of elasticity modulus of materials (middle layer) generates moderate finite deformation, and is produced from the relatively high part of the modulus adjacent with middle layer
Raw lesser deformation, the part modulus being in contact with rigid endplate is higher, deformation is nearly free from, thus between rigid endplate
Frictional interface will not be formed because deforming excessive generation interfacial separation.
Fig. 4 is rigid endplate and elastic nucleus pulposus contact interface structure chart up and down in the present invention.
Elastic nucleus pulposus 3 and upper rigid endplate 1, lower rigid endplate 2 contact surface on to be respectively arranged with several wavy
Raised (4a) or several rectangular preiections (4b).
Elastic nucleus pulposus 3 and the contact surface of upper rigid endplate 1, lower rigid endplate 2 are arc-shaped (4c).
Elastic nucleus pulposus 3 and upper rigid endplate 1, lower rigid endplate 2 contact surface on be respectively set fluted, groove is rectangle
Slot (4d), T-slot (4f) or funnel type groove (4e).
Fig. 5 is the schematic diagram of two kinds of forming methods of artificial intervertebral disk in the present invention.By 5a-5d it is found that step are as follows:
(1) upper rigid endplate, lower rigid endplate are placed in mold, the polyurethane material for being 20 ~ 500MPa by elasticity modulus
Material is injected separately into die for molding, respectively obtains rigid endplate-polyurethane material product and lower rigid endplate-polyurethane material
Expect product;
(2) 100 ~ 240 DEG C of forming temperature are controlled, repeats step (1) in the upper rigid endplate-polyurethane material being prepared
The several polyurethane lower than step (1) Elastic Modulus is implanted sequentially on product and lower rigid endplate-polyurethane material product
Material obtains the different piece of elastic nucleus pulposus;
(3) the upper rigid endplate-polyurethane material product obtained step (2) and lower rigid endplate-polyurethane material system
Part is placed in mold, realizes the upper poly- ammonia of rigid endplate-lower than the polyurethane material of the elasticity modulus in step (2) in intermediate injection
Ester material product and the connection of lower rigid endplate-polyurethane material product, are prepared artificial intervertebral disk.
Claims (3)
1. a kind of forming method of the artificial intervertebral disk of no interface friction, characterized by the following steps:
(1) upper rigid endplate (1), lower rigid endplate (2) are placed in mold, are the poly- of 20 ~ 500MPa by elastic nucleus pulposus modulus
Urethane material is injected separately into die for molding, respectively obtains rigid endplate-polyurethane material product and lower rigid endplate-is poly-
Urethane material;
(2) 100 ~ 240 DEG C of forming temperature are controlled, repeats step (1) in the upper rigid endplate-polyurethane material product being prepared
With the several polyurethane material lower than step (1) Elastic Modulus is implanted sequentially on lower rigid endplate-polyurethane material product
Obtain the different piece of elastic nucleus pulposus;
(3) upper rigid endplate-polyurethane material product and lower rigid endplate-polyurethane material product that step (2) obtains are set
In mold, upper rigid endplate-polyurethane material is realized lower than the polyurethane material of the elasticity modulus in step (2) in intermediate injection
Expect product and the connection of lower rigid endplate-polyurethane material product, artificial intervertebral disk is prepared;
Uneven distribution is presented in the modulus of elastic nucleus pulposus, and distribution pattern is by the material modulus rank close to rigid endplate to nucleus pulposus center
Ladder type variation, or changed by rigid endplate to nucleus pulposus center material modulus gradual change type;
The elasticity nucleus pulposus (3) and the elasticity modulus of upper rigid endplate (1), the material of lower rigid endplate (2) contact side are higher than
The elasticity modulus of material at elastic nucleus pulposus center;
It is described elasticity nucleus pulposus (3) and upper rigid endplate (1), lower rigid endplate (2) contact surface on be respectively arranged with several waves
The protrusion of wave-like.
2. a kind of forming method of the artificial intervertebral disk of no interface friction as described in claim 1, it is characterised in that: the bullet
Property nucleus pulposus (3) and upper rigid endplate (1), lower rigid endplate (2) contact surface on be respectively arranged with T-slot or funnel type groove.
3. a kind of forming method of the artificial intervertebral disk of no interface friction as described in claim 1, it is characterised in that: elastic intramarrow
Core (3) and the contact surface of upper rigid endplate (1), lower rigid endplate (2) are arc-shaped (4c).
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CN109381282A (en) * | 2017-08-04 | 2019-02-26 | 上海三友医疗器械股份有限公司 | A kind of polar artificial disc construction |
CN210644254U (en) * | 2018-06-12 | 2020-06-02 | 深圳市立心科学有限公司 | Intervertebral fusion device with buffer part |
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CN112089510A (en) * | 2020-10-12 | 2020-12-18 | 四川大学华西医院 | Cervical vertebra intervertebral height maintaining device with shock-absorbing implant-bone interface load effect |
CN112237499B (en) * | 2020-11-17 | 2022-06-14 | 北京爱康宜诚医疗器材有限公司 | Intervertebral fusion device |
CN112451178A (en) * | 2020-11-30 | 2021-03-09 | 北京市创伤骨科研究所 | Integrated bionic elastic artificial intervertebral disc and integrated forming preparation process thereof |
CN112515820A (en) * | 2020-11-30 | 2021-03-19 | 北京市创伤骨科研究所 | Elastic artificial intervertebral disc with gradient modulus and preparation method thereof |
CN112294503A (en) * | 2020-11-30 | 2021-02-02 | 北京市创伤骨科研究所 | Combined elastic artificial intervertebral disc |
CN113017937A (en) * | 2021-03-08 | 2021-06-25 | 吉林大学 | Rigid-flexible coupling buffer bionic intervertebral disc |
CN113017935A (en) * | 2021-03-08 | 2021-06-25 | 吉林大学 | Anti-fatigue fracture bionic intervertebral disc |
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