CN114292431A - Ultra-high molecular weight polyethylene implant, preparation method thereof and joint prosthesis - Google Patents
Ultra-high molecular weight polyethylene implant, preparation method thereof and joint prosthesis Download PDFInfo
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- CN114292431A CN114292431A CN202111403462.4A CN202111403462A CN114292431A CN 114292431 A CN114292431 A CN 114292431A CN 202111403462 A CN202111403462 A CN 202111403462A CN 114292431 A CN114292431 A CN 114292431A
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- 239000004699 Ultra-high molecular weight polyethylene Substances 0.000 title claims abstract description 140
- 229920000785 ultra high molecular weight polyethylene Polymers 0.000 title claims abstract description 140
- 239000007943 implant Substances 0.000 title claims abstract description 67
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 238000004132 cross linking Methods 0.000 claims abstract description 89
- 238000010894 electron beam technology Methods 0.000 claims abstract description 86
- 229910052751 metal Inorganic materials 0.000 claims abstract description 34
- 239000002184 metal Substances 0.000 claims abstract description 34
- 238000000137 annealing Methods 0.000 claims abstract description 16
- 238000000034 method Methods 0.000 claims abstract description 14
- 239000012298 atmosphere Substances 0.000 claims abstract description 5
- 230000001681 protective effect Effects 0.000 claims abstract description 4
- 229910000831 Steel Inorganic materials 0.000 claims description 26
- 239000010959 steel Substances 0.000 claims description 26
- 229910052782 aluminium Inorganic materials 0.000 claims description 20
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 20
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 238000010438 heat treatment Methods 0.000 claims description 3
- 230000002829 reductive effect Effects 0.000 abstract description 15
- 210000000629 knee joint Anatomy 0.000 description 28
- 210000004394 hip joint Anatomy 0.000 description 23
- 230000000052 comparative effect Effects 0.000 description 20
- 210000001624 hip Anatomy 0.000 description 11
- 230000008859 change Effects 0.000 description 10
- 210000003127 knee Anatomy 0.000 description 10
- 230000035515 penetration Effects 0.000 description 10
- 125000006850 spacer group Chemical group 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- 230000007423 decrease Effects 0.000 description 6
- 230000008569 process Effects 0.000 description 6
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 5
- 230000007774 longterm Effects 0.000 description 4
- 230000005855 radiation Effects 0.000 description 4
- 208000003076 Osteolysis Diseases 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
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- MTHLBYMFGWSRME-UHFFFAOYSA-N [Cr].[Co].[Mo] Chemical compound [Cr].[Co].[Mo] MTHLBYMFGWSRME-UHFFFAOYSA-N 0.000 description 2
- 238000005299 abrasion Methods 0.000 description 2
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- 210000002310 elbow joint Anatomy 0.000 description 2
- 125000002573 ethenylidene group Chemical group [*]=C=C([H])[H] 0.000 description 2
- 210000001145 finger joint Anatomy 0.000 description 2
- 239000011888 foil Substances 0.000 description 2
- 230000000873 masking effect Effects 0.000 description 2
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- 238000012986 modification Methods 0.000 description 2
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- 229910052757 nitrogen Inorganic materials 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 238000011056 performance test Methods 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 210000000323 shoulder joint Anatomy 0.000 description 2
- 210000003857 wrist joint Anatomy 0.000 description 2
- 239000005977 Ethylene Substances 0.000 description 1
- 239000004705 High-molecular-weight polyethylene Substances 0.000 description 1
- 238000004566 IR spectroscopy Methods 0.000 description 1
- 230000002238 attenuated effect Effects 0.000 description 1
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- 229910001873 dinitrogen Inorganic materials 0.000 description 1
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- 238000005516 engineering process Methods 0.000 description 1
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- 230000002349 favourable effect Effects 0.000 description 1
- 238000011540 hip replacement Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 239000011261 inert gas Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000012299 nitrogen atmosphere Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
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- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
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Images
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- 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
- A61L27/16—Macromolecular materials obtained 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
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J7/00—Chemical treatment or coating of shaped articles made of macromolecular substances
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J7/00—Chemical treatment or coating of shaped articles made of macromolecular substances
- C08J7/12—Chemical modification
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/04—Homopolymers or copolymers of ethene
- C08L23/06—Polyethene
Abstract
The invention relates to an ultrahigh molecular weight polyethylene implant, a preparation method thereof and a joint prosthesis. The preparation method comprises the following steps: under the protective atmosphere, sequentially carrying out electron beam irradiation crosslinking treatment and annealing treatment on the ultrahigh molecular weight polyethylene molded part; in the electron beam irradiation crosslinking treatment, the energy of the used electron beam is 5 MeV-10 MeV, the irradiation dose is 70 kGy-100 kGy, a metal plate is arranged between the ultra-high molecular weight polyethylene formed part and an electron beam source to shield the friction surface of the ultra-high molecular weight polyethylene formed part, the friction surface is arranged on one side close to the electron beam source, and the thickness of the metal plate is 5 mm-12 mm. The ultra-high molecular weight polyethylene implant product prepared by the method presents gradient cross-linking, and the cross-linking degree of the ultra-high molecular weight polyethylene implant product is gradually reduced from the friction surface to the other side, so that the ultra-high molecular weight polyethylene implant product has mechanical properties such as better wear resistance, better toughness and fatigue resistance.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an ultrahigh molecular weight polyethylene implant, a preparation method thereof and a joint prosthesis.
Background
Due to the excellent mechanical property, self-lubricating property, biocompatibility and other factors, the ultra-high molecular weight polyethylene is widely applied to the field of artificial joint replacement for preparing implants of joint prostheses. However, the micron-sized ultra-high molecular weight polyethylene wear particles generated during the long-term use of the joint prosthesis are the primary cause of osteolysis. Osteolysis in turn can lead to aseptic loosening of the joint prosthesis and to eventual revision of the joint prosthesis. Therefore, current research in the field of artificial joint replacement has focused on reducing the wear rate of ultra-high molecular weight polyethylene hip liners and knee liners when used in conjunction with corresponding femoral heads or condyles.
In artificial hip replacements, highly crosslinked ultra high molecular weight polyethylene acetabular cup liners are often used. The ultra-high molecular weight polyethylene is crosslinked by an electron beam irradiation or ray irradiation method, and the mobility of a conformation chain segment of a crosslinked polymer chain is reduced, so that the friction resistance of the ultra-high molecular weight polyethylene acetabular cup lining is improved; on the other hand, however, crosslinking reduces some of the mechanical properties of the ultra-high molecular weight polyethylene, such as the toughness and fatigue resistance of the highly crosslinked ultra-high molecular weight polyethylene. In the artificial knee joint replacement, since the movement of the knee joint part including rotation, sliding, twisting, etc. is more complicated than that of the hip joint part, there is no current theory as to whether the knee joint pad uses ultra-high molecular weight polyethylene which is highly cross-linked or not cross-linked. However, both the hip joint lining and the knee joint lining need to have good friction resistance and mechanical properties.
Therefore, it is necessary to develop a new joint prosthesis such as an artificial hip/knee which has mechanical properties such as toughness and fatigue resistance of the uncrosslinked ultrahigh molecular weight polyethylene in addition to wear resistance of the highly crosslinked ultrahigh molecular weight polyethylene, thereby improving safety of the joint prosthesis such as an artificial hip/knee in long-term use.
Disclosure of Invention
Therefore, the ultra-high molecular weight polyethylene implant with better wear resistance and better mechanical properties such as toughness and fatigue resistance, the preparation method thereof and the joint prosthesis are needed to be provided.
A preparation method of an ultra-high molecular weight polyethylene implant comprises the following steps:
under the protective atmosphere, sequentially carrying out electron beam irradiation crosslinking treatment and annealing treatment on the ultrahigh molecular weight polyethylene molded part;
in the electron beam irradiation crosslinking treatment, the energy of the used electron beam is 5 MeV-10 MeV, the irradiation dosage is 70 kGy-100 kGy, a metal plate is arranged between the ultra-high molecular weight polyethylene formed part and an electron beam source to shield a friction surface of the ultra-high molecular weight polyethylene formed part, the friction surface is arranged on one side close to the electron beam source, and the thickness of the metal plate is 5 mm-12 mm.
In some of the embodiments, the irradiation temperature of the electron beam irradiation crosslinking treatment is 20 ℃ to 120 ℃.
In some of the embodiments, the irradiation temperature of the electron beam irradiation crosslinking treatment is 60 ℃ to 120 ℃.
In some of these embodiments, the method of making further comprises the steps of:
and before the electron beam irradiation crosslinking treatment, heating the ultra-high molecular weight polyethylene formed part to 60-120 ℃, and preserving heat for 0.5-1 h.
In some embodiments, the annealing temperature is 120-150 ℃, and the treatment time is 5-10 h.
In some of these embodiments, the metal plate is an aluminum plate or a steel plate.
In some embodiments, the electron beam has an energy of 9MeV to 10MeV and an irradiation dose of 73 to 77kGy, and the metal plate has a thickness of 8mm to 10 mm.
An ultra-high molecular weight polyethylene implant prepared by the preparation method.
In some of these embodiments, the crosslinked layer of the ultra-high molecular weight polyethylene implant has a thickness of 10mm to 20 mm.
A joint prosthesis comprises a first support body and the ultrahigh molecular weight polyethylene implant; the ultra-high molecular weight polyethylene implant is matched with the first support body.
In some of these embodiments, the joint prosthesis is a knee joint, a hip joint, a condyle joint, an elbow joint, a wrist joint, a finger joint, or a shoulder joint.
In some of these embodiments, the ultra high molecular weight polyethylene implant is an acetabular cup liner or a knee joint liner.
The preparation method of the ultrahigh molecular weight polyethylene implant comprises the steps of sequentially carrying out electron beam irradiation crosslinking treatment and annealing treatment on an ultrahigh molecular weight polyethylene formed part, and placing a metal plate between the ultrahigh molecular weight polyethylene formed part and an electron beam source in the electron beam irradiation crosslinking treatment to shield a friction surface of the ultrahigh molecular weight polyethylene formed part, wherein the friction surface is placed on one side close to the electron beam source; meanwhile, the formed ultra-high molecular weight polyethylene implant product is subjected to gradient cross-linking within a certain thickness range by controlling the energy and the irradiation dose of the used electron beams and the thickness of the metal plate, and the cross-linking degree of the ultra-high molecular weight polyethylene implant product is gradually reduced from the friction surface to the other side, so that the ultra-high molecular weight polyethylene implant product is higher in cross-linking degree on the friction surface, the friction resistance of the ultra-high molecular weight polyethylene implant product is improved, and lower or no cross-linking degree is realized on a body of the ultra-high molecular weight polyethylene implant product far away from the friction surface. In addition, the crosslinking degree of the ultra-high molecular weight polyethylene implant product is changed in a gradient manner, the problem that the product is deformed due to the difference of internal stress possibly caused by the rapid change of the crosslinking density is solved, the ultra-high molecular weight polyethylene implant product has better mechanical properties, can be excellent in toughness, fatigue resistance and the like, can improve the safety of long-term use, and can prolong the service life of the ultra-high molecular weight polyethylene implant product in artificial hip joint replacement.
Drawings
FIG. 1 is a schematic structural view of a joint prosthesis according to an embodiment of the present invention;
FIG. 2 is a schematic view showing the structure of a knee joint spacer product obtained in example 2;
FIG. 3 is a graph of trans-vinylene index versus friction face depth for the interior of the hip liner products made in example 1 and comparative example 1;
FIG. 4 is a graph of trans-vinylene index versus distance friction face depth for knee joint spacer products made in example 2 and comparative example 2;
FIG. 5 is a graph of the trans-vinylene index in the hip joint lining products prepared in examples 3-8 as a function of the depth from the friction surface;
FIG. 6 is a graph of the trans-vinylene index as a function of distance from the friction surface depth for knee joint spacer products made in examples 9-14;
FIG. 7 is a graph of trans-vinylene index as a function of penetration depth for the interior of hip liners made in examples 1 and 15;
fig. 8 is a graph of trans-vinylene index as a function of penetration depth for the interior of knee pads made in examples 2 and 16.
Detailed Description
To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
The traditional irradiation crosslinking method controls the crosslinking degree of the ultra-high molecular weight polyethylene by controlling the irradiation dose of electron beams or gamma rays, but cannot solve the problems of better wear resistance and better mechanical properties such as toughness, fatigue resistance and the like. For ultra-high molecular weight polyethylene products, the penetrability of gamma radiation is not limited, and the ultra-high molecular weight polyethylene products can be completely crosslinked. For example, the friction resistance of the ultra-high molecular weight polyethylene can be improved by nearly 50% by irradiation crosslinking with 50kGy gamma rays, and then the mechanical properties of the ultra-high molecular weight polyethylene can be reduced by further increasing the irradiation dose.
An embodiment of the present invention provides an ultra-high molecular weight polyethylene implant and a method for preparing the same. The ultra-high molecular weight polyethylene implant obtained will be described in detail below with reference to the preparation method.
An embodiment of the present invention provides a method for preparing an ultra-high molecular weight polyethylene implant, including the following step S20.
Step S20: and sequentially carrying out electron beam irradiation crosslinking treatment and annealing treatment on the ultrahigh molecular weight polyethylene molded part in a protective atmosphere.
In the electron beam irradiation crosslinking treatment of step S20, the energy of the electron beam is 5MeV to 10MeV, and the irradiation dose is 70kGy to 100kGy, and a metal plate is placed between the ultra-high molecular weight polyethylene molded part and the electron beam source to shield a friction surface of the ultra-high molecular weight polyethylene molded part, the friction surface is placed on a side close to the electron beam source, and the thickness of the metal plate is 5mm to 12 mm.
In some of these embodiments, a thickness of the crosslinked layer of 10mm to 20mm may be achieved.
For ultra high molecular weight polyethylene products, the penetration depth of the electron beam radiation depends on the electron beam energy, e.g., a 10MeV electron beam penetration depth of about 3.2 cm. The invention controls the energy of the electron beam to mainly change the penetration depth of the electron beam to the sample of the ultra-high molecular weight polyethylene molded part, so that the irradiation dose is approximately and uniformly distributed in the penetration depth range when no metal plate is added for shielding; the shielding of the electron beam can be realized to a certain degree by the shielding mode of the metal plate, so that the energy of the electron beam passing through the metal plate is attenuated to a certain degree, the irradiation dose of the ultra-high molecular weight polyethylene molded part sample is controlled by the mode, gradient crosslinking is formed in the ultra-high molecular weight polyethylene implant product, and the gradient crosslinked ultra-high molecular weight polyethylene implant product is prepared.
The preparation method of the ultra-high molecular weight polyethylene implant comprises the steps of sequentially carrying out electron beam irradiation crosslinking treatment and annealing treatment on an ultra-high molecular weight polyethylene formed part, and adopting a metal plate to be arranged between the ultra-high molecular weight polyethylene formed part and an electron beam source in the electron beam irradiation crosslinking treatment so as to shield a friction surface of the ultra-high molecular weight polyethylene formed part, wherein the friction surface is arranged on one side close to the electron beam source; meanwhile, the energy and the irradiation dose of the used electron beams and the thickness of the metal plate are controlled, so that the formed ultra-high molecular weight polyethylene implant product presents gradient cross-linking in a certain thickness range, and the cross-linking degree of the ultra-high molecular weight polyethylene implant product is gradually reduced from a friction surface to the other side, so that the ultra-high molecular weight polyethylene implant product presents higher cross-linking degree on the friction surface, the friction resistance of the ultra-high molecular weight polyethylene implant product is improved, and lower or no cross-linking degree is realized on a body of the ultra-high molecular weight polyethylene implant product far away from the friction surface. In addition, the crosslinking degree of the ultra-high molecular weight polyethylene implant product is changed in a gradient manner, the problem of product deformation caused by internal stress difference possibly caused by rapid change of crosslinking density is solved, the ultra-high molecular weight polyethylene implant product has good mechanical property, can be excellent in toughness, fatigue resistance and the like, and further can improve the safety of long-term use and prolong the service life of the ultra-high molecular weight polyethylene implant product in artificial hip joint replacement.
It will be appreciated that the rubbing surface is disposed on the side close to the electron beam source so that the metal plate is disposed opposite to the rubbing surface to completely cover the rubbing surface, thereby achieving shielding of the rubbing surface of the ultra-high molecular weight polyethylene molded part by the metal plate. Specifically, the shape and the area of the metal plate are set to ensure that a product to be irradiated is completely shielded so as to control the irradiation dose of the ultra-high molecular weight polyethylene formed part. It is understood that the ultra high molecular weight polyethylene implant has a friction surface for mating. For example, acetabular cup liner blanks and knee joint liner blanks are typically made from ultra high molecular weight polyethylene and have friction surfaces for mating.
According to the preparation method of the ultra-high molecular weight polyethylene implant, other processes are not required to be changed by means of the metal plate, gradient crosslinking of the ultra-high molecular weight polyethylene implant product is simply realized, and the ultra-high molecular weight polyethylene implant product has mechanical properties such as better wear resistance, better toughness and fatigue resistance; and furthermore, in the application of the artificial joint prosthesis, the generation of abrasive dust particles caused by friction is reduced, so that the risk of osteolysis is reduced, the revision rate of the replacement of the ultra-high molecular weight polyethylene implant is reduced, the service life of the artificial joint prosthesis in a human body is prolonged, and the artificial joint prosthesis is more suitable for the artificial joint replacement technology.
In addition, the preparation method of the ultrahigh molecular weight polyethylene implant has no strict requirements on the appearance and the structure of the ultrahigh molecular weight polyethylene molded part sample, and under the same condition, the irradiation doses at the same depth from the friction surface of the ultrahigh molecular weight polyethylene molded part sample are nearly equal. It is understood that the morphology and structure of the molded ultra-high molecular weight polyethylene part sample can be controlled by the shape and structure of the mold.
In some embodiments, the gradient cross-linking thickness of the ultra-high molecular weight polyethylene implant product from the friction surface to the other side prepared by the above preparation method is 10mm to 20 mm. It is understood that the thickness of the gradient cross-linking herein refers to the thickness of the product exhibiting a change in the gradient cross-linking. In other words, the ultra-high molecular weight polyethylene implant product forms a cross-linked layer from the friction surface to the other side as a gradient cross-linked layer, and the cross-linking degree of the cross-linked layer gradually decreases from the friction surface to the other side; namely, the thickness of the crosslinked layer is 10mm to 20 mm. It will be appreciated that the opposite side may be a base opposite the friction surface, i.e. the ultra high molecular weight polyethylene implant product comprises a body having a friction surface on one side and a base on the other side.
Further, the molded article of ultra-high molecular weight polyethylene prepared by the above preparation method is preferably selected from molded articles having a thickness from the rubbing surface to the other side which is the same as the thickness of the gradient cross-linking (i.e., the thickness of the cross-linked layer), so that the formed ultra-high molecular weight polyethylene implant product exhibits gradient cross-linking from the rubbing surface to the substrate.
In one example, the rate of change of the degree of crosslinking of the ultra high molecular weight polyethylene implant product is expressed as the rate of change of the trans-ethylene index with depth from the friction surface; wherein the depth from the friction surface is the depth from a point inside the ultra-high molecular weight polyethylene implant product to the friction surface.
In one particular example, the ultra-high molecular weight polyethylene implant product has a relationship between trans-vinylene index and depth from friction surface that satisfies the following functional relationship:
TVI＝-0.0012D+A；
wherein TVI means Trans vinylidene Index (Trans vinyl Index); d is the depth from the friction surface, and is a numerical value in mm; a is a constant depending on the thickness of the metal plate. For example, a is about 0.038 for a sheet metal thickness of 8 mm.
In some of the embodiments, the irradiation temperature of the electron beam irradiation crosslinking treatment is 20 ℃ to 120 ℃. The irradiation temperature of the electron beam irradiation crosslinking treatment is the temperature of the ultrahigh molecular weight polyethylene formed part during the electron beam irradiation crosslinking treatment. The verification proves that the electron beam irradiation crosslinking treatment can be carried out at normal temperature and under the heating condition of the ultrahigh molecular weight polyethylene formed part, and the gradient crosslinking can be realized. Preferably under heated conditions.
Furthermore, the irradiation temperature of the electron beam irradiation crosslinking treatment is 60-120 ℃. The temperature of the ultra-high molecular weight polyethylene molding part is subjected to electron beam irradiation crosslinking treatment at the irradiation temperature, and crosslinking reaction is easy to occur.
In some embodiments, the preparation method further comprises the following step S10: before the electron beam irradiation crosslinking treatment, the ultra-high molecular weight polyethylene molding piece is heated to 60-120 ℃ and is kept warm for 0.5-1 h.
In some embodiments, the annealing treatment is performed at 120-150 ℃ for 5-10 h.
In some of these embodiments, the metal plate is an aluminum plate or a steel plate. It is understood that the material selection of the metal plate is not limited thereto.
In some of these embodiments, the electron beam is used at an energy of 9MeV to 10MeV, at an irradiation dose of 73kGy to 77kGy, and at a thickness of 8mm to 10 mm. Within this preferred range, maximum cross-linking of the friction face is achieved, with progressively lower cross-linking levels within the body of the product deeper from the friction face.
Another embodiment of the present invention further provides a joint prosthesis, which comprises a first supporting body 110 and the above-mentioned ultrahigh molecular weight polyethylene implant 120. The ultra-high molecular weight polyethylene implant 120 is fitted with the first support body 110.
Further, a second supporting body 130 is included, wherein the ultra-high molecular weight polyethylene implant 120 is disposed between the first supporting body 110 and the second supporting body 130.
It is understood that the ultra-high molecular weight polyethylene implant 120 may also be engaged with only one support (e.g., the first support 110 or the second support 130), in which case the friction surface of the ultra-high molecular weight polyethylene implant 120 and the surface of the support rub against each other.
In some of these embodiments, the joint prosthesis is a hip joint, a knee joint, a condyle joint, an elbow joint, a wrist joint, a finger joint, or a shoulder joint. It is understood that joint prostheses include, but are not limited to, these.
In particular, in the specific example shown in fig. 1, in particular, taking the joint prosthesis as a hip joint for example, the ultra high molecular weight polyethylene implant may be an acetabular cup liner. Further, the first support body 110 and the second support body 130 are an acetabular prosthesis and a femoral head prosthesis, respectively; the friction surface of the ultra-high molecular weight polyethylene implant 120 is the side thereof that is adjacent to the femoral head prosthesis.
In the case of a knee prosthesis, the ultra-high molecular weight polyethylene implant 120 may be a knee joint spacer. Further, the first support body 110 and the second support body 130 are a tibial tray and a femoral condyle prosthesis, respectively, and the friction surface of the ultra-high molecular weight polyethylene implant 120 is a side thereof close to the femoral condyle prosthesis.
In order to make the objects, technical solutions and advantages of the present invention more concise and clear, the present invention is described with the following specific embodiments, but the present invention is by no means limited to these embodiments. The following described examples are only preferred embodiments of the present invention, which can be used to describe the present invention and should not be construed as limiting the scope of the present invention. It should be understood that any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
In order to better illustrate the invention, the following examples are given to further illustrate the invention. The following are specific examples.
Example 1
A hip joint lining product was prepared as shown in fig. 1 for the ultra high molecular weight polyethylene implant 120.
And sealing the ultrahigh molecular weight polyethylene acetabular cup lining forming piece in an aluminum foil bag in a nitrogen gas atmosphere by using a vacuumizing inert gas filling sealing machine. And during packaging, repeatedly vacuumizing and filling nitrogen for at least 3 times, and finally, thermally sealing the high-molecular-weight polyethylene acetabular cup lining forming part in the aluminum foil bag in the nitrogen atmosphere.
Performing electron beam irradiation crosslinking on the ultra-high molecular weight polyethylene hip joint lining forming part packaged in nitrogen at normal temperature (25 ℃), wherein a metal plate is arranged between the ultra-high molecular weight polyethylene forming part and an electron beam source to shield a friction surface of the ultra-high molecular weight polyethylene acetabular cup lining forming part in the electron beam irradiation crosslinking treatment, and the friction surface is arranged on one side close to the electron beam source. Wherein the irradiation dose of the electron beam is 75kGy, the annealing temperature after irradiation is 120 ℃, the annealing time is 9h, and the thickness of the aluminum plate used in the irradiation process of the electron beam is 8 mm.
Comparative example 1
Essentially the same as in example 1, except that: and an aluminum plate is not added for shielding in the electron beam irradiation process.
Example 2
Knee joint padding products were prepared as shown in fig. 2.
Essentially the same as in example 1, except that: and replacing the ultrahigh molecular weight polyethylene acetabular cup lining forming part with an ultrahigh molecular weight polyethylene knee joint liner forming part.
Comparative example 2
Essentially the same as example 2, except that: and an aluminum plate is not added for shielding in the electron beam irradiation process.
The hip joint liners and knee joint liners prepared in examples 1 to 2 and comparative examples 1 to 2 were subjected to a test of a change in internal trans-vinylene index with depth from a friction surface, and the trans-vinylene index (TVI) of the interior of ultra-high molecular weight polyethylene, namely 965cm was detected by infrared spectroscopy with reference to the YY/T0814-2010 method-1The area of absorption peak at (E) and 1330cm-1～1396cm-1The total area ratio of the absorption peaks determines the irradiation dose level of the ultra-high molecular weight polyethylene product for absorbing electron beams, and further reflects the crosslinking degree of the ultra-high molecular weight polyethylene. The results are shown in FIGS. 1 and 3.
Figure 3 shows a graph of trans-vinylene index as a function of distance friction face depth for the interior of hip joint lining products made in example 1 and comparative example 1 with and without aluminum plate masking. Wherein the abscissa is Depth from Depth to Sample, namely the Depth from the friction surface, and the unit is mm; the ordinate is the Trans-Vinylene Index (TVI), as follows. Where No shield means No shield, the corresponding proportion 1, 8mm shield means example 1, and the following is similar.
Figure 4 shows a graph of trans-vinylene index as a function of distance friction face depth for knee joint spacer products made in example 2 and comparative example 2 with and without aluminum plate masking.
As can be seen from FIGS. 3 to 4, when the ultra-high molecular weight polyethylene product is subjected to electron beam irradiation crosslinking, the trans-vinylene index (TVI) shows equal dose distribution in the hip joint lining and the knee joint liner in the condition of no aluminum plate shielding in proportion of 1-2, and is higher than the condition of shielding irradiation by adding an aluminum plate, which indicates that relatively uniform irradiation crosslinking occurs in the whole irradiation product.
When 8mm thick aluminum plates are used for shielding in examples 1-2, the trans-vinylidene index (TVI) gradually decreases with increasing depth from the friction surface, and shows nearly linear change, which indicates that gradient crosslinking occurs inside the irradiated ultrahigh molecular weight polyethylene product. The closer the hip and knee liners are to the friction surface, the higher the degree of cross-linking, while the farther the hip and knee liners are from the base of the friction surface, the lower the degree of cross-linking.
As can be seen from the comparison of fig. 3 to 4, the structure and shape of the sample to be irradiated (i.e., the molded article) have no significant influence on the electron beam irradiation effect, and the irradiation dose distribution is nearly the same within the same depth range from the irradiated surface (friction surface) of the product.
Some of the key parameters of examples 1-2 and comparative examples 1-2 are shown in Table 1 below:
TABLE 1
| Group of | Temperature of irradiation | Energy of electron beam | Dose of radiation | Metal plate | Annealing treatment |
| Example 1 | At normal temperature | 10MeV | 75kGy | Aluminum plate, |
120℃，9h |
| Example 2 | At normal temperature | 10MeV | 75kGy | Aluminum plate, |
120℃，9h |
| Comparative example 1 | At normal temperature | 10MeV | 75kGy | - | 120℃，9h |
| Comparative example 2 | At normal temperature | 10MeV | 75kGy | - | 120℃，9h |
Comparative example 3
Is an uncrosslinked ultra-high molecular weight polyethylene hip joint lining product.
Comparative example 4
Is an uncrosslinked ultra-high molecular weight polyethylene knee joint liner product.
Examples 3 to 8
Essentially the same as in example 1, except that: and in the irradiation process, the steel plate is adopted to replace the aluminum plate in the embodiment 1, and the thicknesses of the steel plates used in the embodiments 3-8 are respectively 1mm, 3mm, 5mm, 8mm, 10mm and 12 mm.
Some of the key parameters for examples 3-8 are shown in Table 2 below:
TABLE 2
| Group of | Temperature of irradiation | Energy of electron beam | Dose of radiation | Metal plate | Annealing treatment |
| Example 3 | At normal temperature | 10MeV | 75kGy | Steel plate, |
120℃，9h |
| Example 4 | At normal temperature | 10MeV | 75kGy | Steel plate, |
120℃，9h |
| Example 5 | At normal temperature | 10MeV | 75kGy | Steel plate, |
120℃，9h |
| Example 6 | At normal temperature | 10MeV | 75kGy | Steel plate, |
120℃，9h |
| Example 7 | At normal temperature | 10MeV | 75kGy | Steel plate, |
120℃，9h |
| Example 8 | At normal temperature | 10MeV | 75kGy | Steel plate, |
120℃，9h |
Examples 9 to 14
Essentially the same as example 2, except that: and in the irradiation process, the steel plate is adopted to replace the aluminum plate in the embodiment 2, and the thicknesses of the steel plates used in the embodiments 9-14 are respectively 1mm, 3mm, 5mm, 8mm, 10mm and 12 mm.
Some of the key parameters for examples 9-14 are shown in Table 3 below:
TABLE 3
FIG. 5 shows graphs of trans-vinylene index (TVI) as a function of penetration depth for hip joint lining products made in examples 3-8 at different steel plate thicknesses.
FIG. 6 is a graph showing the trans-vinylene index (TVI) as a function of penetration depth for knee joint spacer products made in examples 9-14 at different plate thicknesses.
As can be seen from fig. 5 to 6, when the thickness of the steel plate is 1mm and 3mm, the trans-vinylene index shows equal dose distribution in the hip joint lining and knee joint lining products, which indicates that relatively uniform irradiation crosslinking occurs in the whole product.
When a steel plate with the thickness of 5mm, 8mm, 10mm and 12mm is used for shielding, the trans-vinylidene index (TVI) is gradually reduced in the hip joint lining and the knee joint lining and shows near-linear change, the crosslinking degree on the friction surface of the hip joint lining and the knee joint lining is higher, and the crosslinking degree on the base of the hip joint lining and the knee joint lining is lower, which indicates that gradient crosslinking occurs in the irradiation product.
On the other hand, as the thickness of the steel sheet increases, the trans-vinylene index (TVI) gradually decreases at the same thickness, indicating that the thicker steel sheet provides greater shielding against electron beam irradiation. When the thickness of the steel plate exceeds 12mm or more, the electron beam irradiation dose is much reduced, and the trans-vinylene index signal is so weak as to be undetectable.
Example 15
Essentially the same as in example 1, except that: before the step of electron beam irradiation crosslinking, the ultra-high molecular weight polyethylene hip joint lining forming piece is heated to 120 ℃ and is kept warm for 0.5h, so that the electron beam irradiation crosslinking is carried out at 120 ℃.
Example 16
Essentially the same as example 2, except that: before the step of electron beam irradiation crosslinking, the knee joint gasket formed part made of ultra-high molecular weight polyethylene is heated to 120 ℃ and is kept warm for 1h, so that the electron beam irradiation crosslinking is carried out at 120 ℃.
Some of the key parameters for examples 15-16 are shown in Table 4 below:
TABLE 4
Figure 7 shows a graph of trans-vinylene index inside hip liners made for examples 1 and 15 at different irradiation temperatures as a function of penetration depth. Wherein RT represents normal temperature, corresponding to example 1; 120 ℃ corresponds to example 15, analogously below.
Fig. 8 shows a graph of trans-vinylene index as a function of penetration depth for knee joint liners made in examples 2 and 16 at different irradiation temperatures.
As can be seen from fig. 7 to 8, when the aluminum plate had a thickness of 8mm, the trans-vinylene index (TVI) exhibited a gradient change in both the hip liner and the knee liner at normal temperature and at 120 ℃, and the degree of crosslinking was high on the friction surfaces of the hip liner and the knee liner, and low on the bases of the hip liner and the knee liner, indicating that gradient crosslinking occurred inside both products. However, at 120 ℃ elevated temperature, the relative Trans Vinylidene Index (TVI) content is higher, indicating that elevated temperature is more favorable for the crosslinking reaction of the ultra-high molecular weight polyethylene. Studies have shown that at high temperatures (120 ℃), ultrahigh molecular weight polyethylene has a lower density and a lower crystallinity, and therefore free radicals generated during irradiation are more likely to crosslink.
It is shown by the above examples and comparative examples that the irradiation temperature has less influence on the degree of crosslinking of the ultra-high molecular weight polyethylene during electron beam irradiation, while the thickness of the metal plate has more influence. When the thickness of the steel plate reaches more than 5mm, gradient crosslinking can be formed in the ultra-high molecular weight polyethylene hip joint lining and the knee joint liner, and the gradient crosslinking density can also be adjusted through the thickness of the steel plate to directly form a gradient crosslinking product.
Example 17
Essentially the same as in example 1, except that: the energy and the irradiation dose of the electron beam are different, and the specific energy and the irradiation dose of the electron beam are respectively 5MeV and 70 kGy.
Example 18
Essentially the same as in example 1, except that: the energy and the irradiation dose of the electron beam are different, the energy of the electron beam is 8MeV, the irradiation dose is 100kGy, and a steel plate with the thickness of 8mm is used for shielding.
Example 19
Essentially the same as in example 1, except that: before the step of electron beam irradiation crosslinking, the ultra-high molecular weight polyethylene hip joint lining forming piece is heated to 60 ℃ and is kept warm for 0.5h, so that the electron beam irradiation crosslinking is carried out at 60 ℃.
Example 20
Essentially the same as in example 1, except that:
before the step of electron beam irradiation crosslinking, the ultra-high molecular weight polyethylene hip joint lining forming piece is heated to 90 ℃ and is insulated for 1h, so that the electron beam irradiation crosslinking is carried out at 90 ℃.
Example 21
Essentially the same as in example 1, except that: the steel plate with the thickness of 8mm is used for shielding, and the annealing treatment condition is 130 ℃ for 5 h.
Example 22
Essentially the same as in example 1, except that: shielding by using a steel plate with the thickness of 8mm, and annealing at 150 ℃ for 10 h.
The mechanical property test and wear resistance test were performed on the acetabular liner product and the knee joint liner product obtained in each example and comparative example, and the results are shown in tables 5 and 6, respectively.
The test conditions of the frictional wear performance are that a cobalt chromium molybdenum ball head (32mm) vs mould pressing acetabular lining, a cobalt chromium molybdenum condyle (CR 8) vs mould pressing tibial liner, and a frictional wear testing machine is used for displacement control, is worn for 500 ten thousand times and is weighed every 50 ten thousand times.
TABLE 5 mechanical and wear Properties testing of acetabular liner products
TABLE 6 mechanical and wear Properties of Knee Joint spacer products
| Group of | Impact strength | Average rate of wear (mg/million times) |
| Example 2 | 81.0 | 25.48 |
| Comparative example 2 | 71.3 | 20.37 |
| Comparative example 4 (uncrosslinked) | 142.8 | 36.45 |
| Example 9 | 70.8 | 20.12 |
| Example 10 | 70.9 | 20.48 |
| Example 11 | 73.9 | 20.56 |
| Example 12 | 81.1 | 25.60 |
| Example 13 | 95.2 | 30.25 |
| Example 14 | 105.1 | 32.87 |
| Example 16 | 80.5 | 25.36 |
From the above test results, it can be seen that, taking examples 1 and 2 as comparative standards, comparative examples 1 and 2 do not use a metal plate for shielding, and all the ultrahigh molecular weight polyethylene is crosslinked, so that the products of comparative examples 1 and 2 have a low average wear rate, but the impact strength is much reduced, and the mechanical properties such as impact resistance are insufficient. Comparative examples 3 to 4 are uncrosslinked products, which have high impact strength, but have a high average wear rate and insufficient wear resistance. The products of examples 1-2 have good mechanical properties such as impact resistance and wear resistance.
In examples 3 to 8, as the thickness of the metal plate increases, the degree of crosslinking of the ultrahigh molecular weight polyethylene decreases, and therefore, the mechanical properties such as impact resistance are improved and the wear resistance is slightly decreased, as compared with example 1. Example 6 the same conditions as in example 1 were used except that the steel sheet was used instead of the aluminum sheet, and the results of the performance tests were also similar, showing that the steel sheet and the aluminum sheet functioned similarly. In the same manner as in examples 9 to 14, the crosslinking degree of the ultrahigh molecular weight polyethylene decreases as the thickness of the metal plate increases, so that the mechanical properties such as impact resistance are improved, and the wear resistance is slightly decreased.
Compared with the embodiment 1, the embodiment 15, the embodiment 19 and the embodiment 20 increase the irradiation temperature, so that the surface crosslinking is easier to carry out, the abrasion resistance is obviously improved, and the mechanical properties such as impact resistance and the like are not obviously reduced; the electron beam energy of the embodiment 17 and the electron beam energy of the embodiment 18 are both reduced, wherein the irradiation dose of the embodiment 17 is lower, so that the crosslinking degree is reduced, the mechanical properties such as impact resistance and the like are improved, the wear resistance is reduced, while the irradiation dose of the embodiment 18 is improved, so that the crosslinking degree is not obviously changed, and the mechanical properties and the wear resistance are not obviously changed; the annealing conditions of the examples 21 and 22 were changed, and the results of the performance test were similar to those of the example 1.
Example 16 increased the irradiation temperature compared to example 2, making the surface cross-linking easier and therefore the abrasion resistance improved significantly without any significant decrease in mechanical properties.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent is subject to the appended claims, and the description and the drawings can be used for explaining the contents of the claims.
Claims (10)
1. A preparation method of an ultrahigh molecular weight polyethylene implant is characterized by comprising the following steps:
under the protective atmosphere, sequentially carrying out electron beam irradiation crosslinking treatment and annealing treatment on the ultrahigh molecular weight polyethylene molded part;
in the electron beam irradiation crosslinking treatment, the energy of the used electron beam is 5 MeV-10 MeV, the irradiation dose is 70 kGy-100 kGy, a metal plate is arranged between the ultra-high molecular weight polyethylene formed part and an electron beam source to shield a friction surface of the ultra-high molecular weight polyethylene formed part, the friction surface is arranged on one side close to the electron beam source, and the thickness of the metal plate is 5 mm-12 mm.
2. The production method according to claim 1, wherein the irradiation temperature of the electron beam irradiation crosslinking treatment is 20 ℃ to 120 ℃.
3. The production method according to claim 1, wherein the irradiation temperature of the electron beam irradiation crosslinking treatment is 60 ℃ to 120 ℃.
4. The method of claim 3, further comprising the steps of:
and before the electron beam irradiation crosslinking treatment, heating the ultra-high molecular weight polyethylene formed part to 60-120 ℃, and preserving heat for 0.5-1 h.
5. The method according to claim 1, wherein the annealing temperature is 120 ℃ to 150 ℃ and the treatment time is 5 hours to 10 hours.
6. The production method according to any one of claims 1 to 5, wherein the metal plate is an aluminum plate or a steel plate.
7. The production method according to any one of claims 1 to 5, wherein the electron beam is used at an energy of 9MeV to 10MeV and an irradiation dose of 73 to 77kGy, and the thickness of the metal plate is 8 to 10 mm.
8. An ultra-high molecular weight polyethylene implant, produced by the method of any one of claims 1 to 7.
9. The ultra-high molecular weight polyethylene implant of claim 8, wherein the thickness of the cross-linked layer of the ultra-high molecular weight polyethylene implant is 10mm to 20 mm.
10. A joint prosthesis, characterized in that it comprises a first support body and an ultra-high molecular weight polyethylene implant according to any one of claims 8 to 9; the ultra-high molecular weight polyethylene implant is matched with the first support body.
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| WO2023088065A1 (en) * | 2021-11-22 | 2023-05-25 | 苏州微创关节医疗科技有限公司 | Ultrahigh-molecular-weight polyethylene implant and preparation method therefor, and joint prosthesis |
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| US20150151866A1 (en) * | 2012-05-11 | 2015-06-04 | The General Hospital Corporation | Antioxidant-stabilized joint implants |
| CN112770789A (en) * | 2020-06-25 | 2021-05-07 | 宽岳医疗器材（苏州）有限公司 | Ultrahigh molecular weight polyethylene surface gradient crosslinking method and application thereof |
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| EP1028760B1 (en) * | 1996-10-15 | 2004-04-14 | Orthopaedic Hospital | Wear resistant surface-gradient cross-linked polyethylene |
| JP5535650B2 (en) * | 2007-01-25 | 2014-07-02 | ザ・ジェネラル・ホスピタル・コーポレイション | Method for producing oxidation-resistant crosslinked polymeric material |
| AU2008296237A1 (en) * | 2007-09-04 | 2009-03-12 | Smith & Nephew Orthopaedics Ag | Ultra high molecular weight polyethylene for bearing surfaces |
| WO2010096771A2 (en) * | 2009-02-20 | 2010-08-26 | The General Hospital Corporation Dba | High temperature melting |
| CN103006354A (en) * | 2012-11-29 | 2013-04-03 | 大连理工大学 | Artificial acetabulum acetabular cup with gradient structure and preparation method thereof |
| CN207262026U (en) * | 2017-12-13 | 2018-04-20 | 山东阳谷巨龙新型材料有限公司 | A kind of Novel steel/plastic composite board |
| US20210237342A1 (en) * | 2018-03-19 | 2021-08-05 | Arevo, Inc. | Cross-Linkable Thermoplastic Polymeric Materials for Use in Additive Manufacturing |
| CN114292431A (en) * | 2021-11-22 | 2022-04-08 | 苏州微创关节医疗科技有限公司 | Ultra-high molecular weight polyethylene implant, preparation method thereof and joint prosthesis |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20040051213A1 (en) * | 2000-12-12 | 2004-03-18 | Muratoglu Orhun K. | Selective controlled manipulation of polymers |
| US20150151866A1 (en) * | 2012-05-11 | 2015-06-04 | The General Hospital Corporation | Antioxidant-stabilized joint implants |
| CN112770789A (en) * | 2020-06-25 | 2021-05-07 | 宽岳医疗器材（苏州）有限公司 | Ultrahigh molecular weight polyethylene surface gradient crosslinking method and application thereof |
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| WO2023088065A1 (en) * | 2021-11-22 | 2023-05-25 | 苏州微创关节医疗科技有限公司 | Ultrahigh-molecular-weight polyethylene implant and preparation method therefor, and joint prosthesis |
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