CN202843852U - Oxidation resisting artificial joint prosthesis - Google Patents

Oxidation resisting artificial joint prosthesis Download PDF

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Publication number
CN202843852U
CN202843852U CN 201220429390 CN201220429390U CN202843852U CN 202843852 U CN202843852 U CN 202843852U CN 201220429390 CN201220429390 CN 201220429390 CN 201220429390 U CN201220429390 U CN 201220429390U CN 202843852 U CN202843852 U CN 202843852U
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Prior art keywords
polyethylene
metal
metal acetabulum
acetabulum
artificial joint
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Withdrawn - After Issue
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CN 201220429390
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Chinese (zh)
Inventor
付俊
沈杰
程亚军
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Ningbo Institute of Material Technology and Engineering of CAS
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Ningbo Institute of Material Technology and Engineering of CAS
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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
    • A61F2/32Joints for the hip
    • A61F2/34Acetabular cups
    • 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

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

The utility model relates to an oxidation resisting artificial joint prosthesis. Existing products are easy to abrade and generate a mass of abrasive dust. The oxidation resisting artificial joint prosthesis comprises a metal acetabulum and a polyethylene liner. The metal acetabulum adopts metal materials and is a hemispheric shell body, a mutually communicated porous structure is arranged on one side of the inner concave face of the metal acetabulum, and the thickness of a part provided with the porous structure in the metal acetabulum is 20%-60% of the total thickness. The polyethylene liner is a hemispheric shell body embedded in the metal acetabulum, one side of the outer convex face of the polyethylene liner is matched with the porous structure of the inner concave face of the metal acetabulum, and the polyethylene liner is tightly combined with the metal acetabulum through the porous structure of the inner side of the metal acetabulum. The polyethylene liner is made of mixtures of ultra-high molecular weight polyethylene and antioxidant, wherein the mass ratio of the mixtures is 1000-10000:1. According to the oxidation resisting artificial joint prosthesis, back frictional wear generated when relative movement occurs is avoided, and prosthesis abrasion cane be reduced. Due to the polyethylene embedded porous structure, the oxidation resisting artificial joint prosthesis has good stability and reliability.

Description

A kind of antioxidation artificial joint prosthesis
Technical field
This utility model relates to a kind of antioxidation artificial joint prosthesis, and this prosthese is applicable to joint replacement, belongs to be implanted into medical instruments field.
Background technology
Ultra-high molecular weight polyethylene since its excellent wearability, good mechanical property and biocompatibility begin for the stressed material of artificial joint liner the sixties in last century.The manufacture method of each parts of artificial joint is of a great variety, and manufacture method has important impact for the mechanical property of artificial joint and wearing and tearing.Traditional method is that the ultra-high molecular weight polyethylene with compression molding or plunger extrusion molding cuts into specific prosthetic element, becomes artificial joint with other assembling parts.During the row joint replacement, need with special operation tool that polyethylene element and hardware is chimeric.Medium-term and long-term stable at acetabular bone in order to guarantee polyethylene liner, usually need to be on metal acetabulum and polyethylene liner the position-limit mechanism of Design and manufacture complexity.In addition, in traditional artificial hip joint, there are at least two frictional interfaces between polyethylene liner and the metal ball-head, between polyethylene liner and the metal acetabulum, because polyethylene liner is often unfixing, these two rubbing surfaces all can carry out relative motion, thereby wearing and tearing, produce a large amount of abrasive dusts, is the main cause that causes the dissolving of Periprosthe bone.
The one-body molded technology of ultra-high molecular weight polyethylene and hardware has unique advantage.The ultra-high molecular weight polyethylene melt is forced the metal acetabulum inwall that embeds porous, form the integral type acetabular bone of physics interlock.Its advantage is: the hole formation of polythene material and metal " interpenetrating structure ", become as a whole, and do not need other Design and manufacture position-limit mechanism, production efficiency improves greatly; In addition, reduced the sliding friction surface of ultra-high molecular weight polyethylene and metal acetabulum, avoided back side wearing and tearing, be beneficial to and reduce rate of depreciation and abrasive dust quantity.
No matter be which kind of prosthese, necessary through sterilization treatment before the implant into body after making finished product, and irradiation sterilization is one of important method.In addition, in order to improve the abrasion resistance properties of prosthese, usually ultra-high molecular weight polyethylene is carried out cross-linking radiation.Irradiation sterilization and cross-linking radiation all can produce free radical, cause polyethylene in stock's phase with after implanting oxidation to occur.The below is respectively from two relevant technical backgrounds of aspect introduction of irradiation sterilization and cross-linking radiation.
Early stage main artificial joint manufacturer generally adopts radiated by gamma-ray sterilization in air, and preserves at the air atmosphere intermediate package.During irradiation, the sub polyethylene subchain is dissociated in air, and the free radical of generation is combined with oxygen molecule rapidly, form peroxy radical, bring out waterfall type oxidation-chain interruption-reactions such as radical transfer, constantly cause Polyethylene Chain generation oxidation, fracture, degraded, the strength of materials and toughness significantly reduce.Serious oxidation namely occurs in such artificial joint after storage surpasses a year and a half, particularly polyethylene lower surface degree of oxidation is the highest, takes second place in the surface.When the artificial joint of irradiation sterilization implants 5-10, the oxygen molecule that dissolves in the knuckle synovia can be invaded the polyethylene prosthese with knuckle synovia, with the alkyl diradical reaction in the polyethylene, generate peroxy radical, peroxy radical causes sub polyethylene subchain generation waterfall type oxidation reaction, and particularly maximum oxidation occurs lower surface, tired toughness drop, lamellar easily occuring peel off, cause prosthese that loosening, dislocation occurs, is the one of the main reasons that causes prosthese (particularly knee-joint prosthesis) to be overhauled.
The polyethylene prosthese is placed vacuum or hypoxia or oxygen-free atmosphere cross-linking radiation, can avoid the oxidation of generating material when irradiation, avoid or reduce the generation of peroxide or peroxy radical.Prosthese is carried out vacuum packaging, inert atmosphere packing, hypoxic atmosphere packing or oxygen-free atmosphere packing during irradiation and behind the irradiation, can greatly improve the stability of polyethylene prosthese in storage process, significantly reduce or avoid occuring oxidation.If adopt air-locked packing, starvation infiltrates, and can further reduce the degree that oxidation occurs during the stock.Yet, free radical stable existence in the polyethylene prosthese that irradiation produces, the polyethylene prosthese that inertia irradiation sterilization and inertia are preserved is behind implant into body, although the degree of oxidation occurs significantly to be reduced, the required time significant prolongation of remarkable oxidation occurs, but prosthese long-term (more than 10 years) oxidation stability in vivo still remains clinical research.
Non-irradiation sterilization technology does not change the sub polyethylene minor structure, does not produce free radical, the polyethylene problem of oxidation that therefore can avoid free radical to cause fully.Oxirane is widely used in the artificial joint sterilization.Its cardinal principle is that oxirane is infiltrated the nearly surface layer of polyethylene prosthese, utilizes the toxicity of oxirane to come kill bacteria, spore etc.After finishing sterilization, oxirane is thoroughly volatilized, chemical reaction does not occur in oxirane and polyethylene, does not have residual.Therefore oxirane is inflammable and explosive, poisonous gas, must implement in strict accordance with international standard in preservation, sterilization, disposal process, especially will avoid residual in the polyethylene prosthese of oxirane.
The remarkable advantage of irradiation sterilization technology is that efficient is high, easy to operate, sterilization is thorough, noresidue, and it is crosslinked that the sub polyethylene subchain is occured, and obtains outstanding abrasion resistance properties.This abrasion resistance properties is most important for clinical manifestation and the service life of polyethylene prosthese.Therefore, the irradiation sterilization technology remains very competitive sterilizing methods, particularly is suitable for the integral type prosthese is carried out sterilization treatment, and key is to develop the free radical that a kind of method produces with constant illumination.
On the other hand, irradiation crosslinking technological is widely used in the abrasion resistance properties that improves the polyethylene prosthese.Similarly, the free radical of irradiation generation is to cause the polyethylene prosthese that the immanent cause of oxidation occurs in vitro and in vivo.Cross-linking radiation and melting recrystallization can be eliminated free radical, thereby improve the oxidation stability of polyethylene prosthese, but melting recrystallization causes poly intensity and toughness significantly to descend, and fatigue rupture easily occurs; Melting recrystallization causes the polyethylene prosthese to produce internal stress.Therefore, cross-linking radiation and melting recrystallization technology are unsuitable for making integral type wear resistant polyethylene prosthese.
Adopt at present antioxidant (such as vitamin E) can improve the oxidation resistance of ultra-high molecular weight polyethylene, make the ultra-high molecular weight polyethylene prosthese behind irradiation sterilization, still can keep good oxidation stability, but exist the limitation of self.The antioxidant that existing patent of invention is not all mentioned beyond the vitamin E is applied to the one-body molded prosthese of ultra-high molecular weight polyethylene-metal, the static stabilization after more not have the antioxidant of announcement except vitamin E to the artificial joint irradiation sterilization.
Summary of the invention
The purpose of this utility model is for the deficiencies in the prior art, and the antioxidation artificial joint prosthesis is provided.
This utility model comprises metal acetabulum and polyethylene liner;
Described metal acetabulum is hemispherical shell, adopts metal material, and its inner concave one side has the loose structure that is interconnected, and the thickness that has the part of loose structure in the metal acetabulum is 20~60 ﹪ of gross thickness; Porosity 50~80 ﹪ of described loose structure, the internal diameter that consists of the hole of loose structure is 100~1000 microns; Described porosity is the spatial volume of the loose structure mesopore ratio long-pending with the loose structure sub-population; Described metal material is rustless steel, CoCr alloy, CoCrMo alloy, Ti or Ti alloy;
Described polyethylene liner is the hemispherical shell that is embedded in the metal acetabulum, and the loose structure of its outer convex surface one side and metal acetabulum inner concave is complementary, and combines closely by loose structure and the metal acetabulum of metal acetabulum inboard;
The material of polyethylene liner is that mass ratio is the ultra-high molecular weight polyethylene of 1000~10000:1 and the mixture of antioxidant; Described polyvinyl resin with super-high molecular weight be molecular weight more than or equal to 1,000,000 daltonian linear polyethylene resins, described antioxidant is a kind of in caffeic acid, gallic acid, the dodecyl gallate;
In the hole of the loose structure of the mixture infiltration metal acetabulum of the part ultra-high molecular weight polyethylene of the outer convex surface of polyethylene liner and antioxidant, and chimeric with the complete physics of metal acetabulum, thus polyethylene liner and metal acetabulum are combined closely.
Ultra-high molecular weight polyethylene of the present utility model-metal integral type prosthese and metal acetabulum become a complete integral body, the back of the body fretting wear of having avoided relatively moving and having occured, can reduce the prosthese wearing and tearing, because polyethylene embeds loose structure, have good stability and reliability, the chimeric structure of polyethylene-metal supports for the polyethylene rubbing surface provides best mechanics, has reduced the prosthese yield stress and the fatigue rupture that cause because of excessive shear, stretching, compression.Prosthese contains potent antioxidant, can adopt gamma ray or electron beam sterilization, also can obtain the higher degree of cross linking by gamma ray or the electron beam to irradiate crosslinked of high dose, improves the antiwear property of prosthese, possesses simultaneously excellent oxidation stability.
Description of drawings
Fig. 1 is structural representation of the present utility model.
The specific embodiment
As shown in Figure 1, a kind of antioxidation artificial joint prosthesis comprises metal acetabulum 1 and polyethylene liner 2.Metal acetabulum 1 is hemispherical shell, adopts rustless steel, CoCr alloy, CoCrMo alloy, Ti or Ti alloy material.Polyethylene liner 2 is hemispherical shell, material is that mass ratio is the ultra-high molecular weight polyethylene of 1000~10000:1 and the mixture of antioxidant, wherein polyvinyl resin with super-high molecular weight be molecular weight more than or equal to 1,000,000 daltonian linear polyethylene resins, antioxidant is a kind of in caffeic acid, gallic acid, the dodecyl gallate.The outer convex surface of polyethylene liner 2 and the inner concave of metal acetabulum 1 closely link together.
Inner concave one side of metal acetabulum 1 has the solid netted loose structure that is interconnected, the thickness that has the part of loose structure in the metal acetabulum 1 is 20~60 ﹪ of gross thickness, porosity 50~80 ﹪ of loose structure, the internal diameter that consists of the hole of loose structure is 100~1000 microns.
The loose structure of outer convex surface one side of polyethylene liner and metal acetabulum inner concave is complementary, and combines closely by loose structure and the metal acetabulum of metal acetabulum inboard.
In the hole of the loose structure of the mixture infiltration metal acetabulum of the part ultra-high molecular weight polyethylene of the outer convex surface of polyethylene liner and antioxidant, and chimeric with the complete physics of metal acetabulum, thus polyethylene liner and metal acetabulum are combined closely.
The method for preparing this antioxidation artificial joint prosthesis is as follows:
Step (1). antioxidant is added mix homogeneously in the organic solvent, form antioxidant solution, again the polyvinyl resin with super-high molecular weight powder is added in the antioxidant solution, after fully mixing 40~80 ℃ lower dry 5~14 days, obtain antioxidant and ultra-high molecular weight polyethylene mix powder;
Described organic solvent is a kind of in acetone, ethanol, the petroleum ether, and every liter of organic solvent adds 50~200 gram antioxidants, and the quality of the polyvinyl resin with super-high molecular weight powder of adding is 1000~10000 times of the quality of the antioxidant that adds;
Step (2). antioxidant and ultra-high molecular weight polyethylene mix powder are placed in the metal acetabulum of hemisphere hull shape, be heated to 180~240 ℃, antioxidant and ultra-high molecular weight polyethylene mix powder become the mixture melt; With pestle type formpiston the mixture melt is forced into 5~25 MPa, forces the mixture melt to penetrate in the hole of loose structure of metal acetabulum; Then be cooled to 110~130 ℃, constant 1~72 hour of 5~25 MPa pressure that maintenance pestle type formpiston applies are down to room temperature again, obtain the prosthese blank after the demoulding;
Step (3). under the room temperature, prosthese blank precision cutting sanding and polishing is become goods.

Claims (4)

1. an antioxidation artificial joint prosthesis comprises metal acetabulum and polyethylene liner, it is characterized in that:
Described metal acetabulum is hemispherical shell, adopts metal material, and its inner concave one side has the loose structure that is interconnected, and the thickness that has the part of loose structure in the metal acetabulum is 20~60 ﹪ of gross thickness;
Described polyethylene liner is the hemispherical shell that is embedded in the metal acetabulum, and the loose structure of its outer convex surface one side and metal acetabulum inner concave is complementary, and combines closely by loose structure and the metal acetabulum of metal acetabulum inboard;
The material of polyethylene liner is that mass ratio is the ultra-high molecular weight polyethylene of 1000~10000:1 and the mixture of antioxidant;
In the hole of the loose structure of the mixture infiltration metal acetabulum of the part ultra-high molecular weight polyethylene of the outer convex surface of polyethylene liner and antioxidant, and chimeric with the complete physics of metal acetabulum.
2. a kind of antioxidation artificial joint prosthesis as claimed in claim 1 is characterized in that: porosity 50~80 ﹪ of described loose structure, the internal diameter that consists of the hole of loose structure is 100~1000 microns.
3. a kind of antioxidation artificial joint prosthesis as claimed in claim 1, it is characterized in that: described metal material is rustless steel, CoCr alloy, CoCrMo alloy, Ti or Ti alloy.
4. a kind of antioxidation artificial joint prosthesis as claimed in claim 1, it is characterized in that: described polyvinyl resin with super-high molecular weight be molecular weight more than or equal to 1,000,000 daltonian linear polyethylene resins, described antioxidant is a kind of in caffeic acid, gallic acid, the dodecyl gallate.
CN 201220429390 2012-08-28 2012-08-28 Oxidation resisting artificial joint prosthesis Withdrawn - After Issue CN202843852U (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102824232A (en) * 2012-08-28 2012-12-19 中国科学院宁波材料技术与工程研究所 Anti-oxidation artificial joint prosthesis and preparation method thereof
CN110368143A (en) * 2019-08-05 2019-10-25 北京爱康宜诚医疗器材有限公司 Humeral head replacement

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102824232A (en) * 2012-08-28 2012-12-19 中国科学院宁波材料技术与工程研究所 Anti-oxidation artificial joint prosthesis and preparation method thereof
CN102824232B (en) * 2012-08-28 2015-07-22 中国科学院宁波材料技术与工程研究所 Anti-oxidation artificial joint prosthesis and preparation method thereof
CN110368143A (en) * 2019-08-05 2019-10-25 北京爱康宜诚医疗器材有限公司 Humeral head replacement

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