CA2260241A1 - Crosslinking of polyethylene for low wear using radiation and thermal treatments - Google Patents

Crosslinking of polyethylene for low wear using radiation and thermal treatments

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Publication number
CA2260241A1
CA2260241A1 CA002260241A CA2260241A CA2260241A1 CA 2260241 A1 CA2260241 A1 CA 2260241A1 CA 002260241 A CA002260241 A CA 002260241A CA 2260241 A CA2260241 A CA 2260241A CA 2260241 A1 CA2260241 A1 CA 2260241A1
Authority
CA
Canada
Prior art keywords
polymer
polymeric composition
crosslinked
irradiated
annealing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002260241A
Other languages
French (fr)
Other versions
CA2260241C (en
Inventor
Fu-Wen Shen
Harry A. Mckellop
Ronald Salovey
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Orthopaedic Hospital
University of Southern California USC
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Individual
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Application filed by Individual filed Critical Individual
Publication of CA2260241A1 publication Critical patent/CA2260241A1/en
Application granted granted Critical
Publication of CA2260241C publication Critical patent/CA2260241C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • 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
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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    • 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
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    • 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
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    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
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    • 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
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30084—Materials having a crystalline structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61F2002/3412—Acetabular cups with pins or protrusions, e.g. non-sharp pins or protrusions projecting from a shell surface
    • A61F2002/3414—Polar protrusion, e.g. for centering two concentric shells
    • 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
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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
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    • A61F2/36—Femoral heads ; Femoral endoprostheses
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    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/08—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation
    • B29C35/0805—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation
    • B29C2035/085—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation using gamma-ray
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C71/00—After-treatment of articles without altering their shape; Apparatus therefor
    • B29C71/02—Thermal after-treatment
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
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    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/04—Polymers of ethylene
    • B29K2023/06—PE, i.e. polyethylene
    • B29K2023/0658—PE, i.e. polyethylene characterised by its molecular weight
    • B29K2023/0675—HMWPE, i.e. high molecular weight polyethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/04—Polymers of ethylene
    • B29K2023/06—PE, i.e. polyethylene
    • B29K2023/0658—PE, i.e. polyethylene characterised by its molecular weight
    • B29K2023/0683—UHMWPE, i.e. ultra high molecular weight polyethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037—Other properties
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    • C08J2323/00—Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers
    • C08J2323/02—Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers not modified by chemical after treatment
    • C08J2323/04—Homopolymers or copolymers of ethene
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Abstract

The present invention discloses methods for enhancing the wear-resistance of polymers, the resulting polymers, and in vivo implants made from such polymers. One aspect of this invention presents a method whereby a polymer is irradiated, preferably with gamma radiation, then thermally treated, such as by remelting or annealing. The resulting polymeric composition preferably has its most oxidized surface layer removed. Another aspect of the invention presents a general method for optimizing the wear resistance and desirable physical and/or chemical properties of a polymer by crosslinking and thermally treating it. The resulting polymeric composition is wear-resistant and may be fabricated into an in vivo implant.

Claims (30)

We claim:
1. A preformed polymeric composition comprising a crosslinked thermally treated polymer.
2. The composition of claim 1, wherein the composition possesses one or more of the following characteristics:
degree of swelling of between about 1.7 to about 5.3; molecular weight between crosslinks of between about 400 to about 8400 g/mol; and a gel content of between about 95 to about 99 %.
3. The composition of claim 1, wherein the preformed polymeric compsition is crosslinked by gamma radiation at a a dose from about 1 to about 100 Mrad.
4. The composition of claim 3, wherein the dose is from about 5 to about 25 Mrad.
5. An in vivo implant comprising a crosslinked and remelted polymer.
6. A method for increasing the wear resistance of a preformed polymeric composition, comprising the steps of:
(a) crosslinking the polymeric composition in a solid state; and (b) subjecting the crosslinked polymeric composition to thermal treatment.
7. The method of claim 6, further comprising the step of removing the most oxidized surface of the thermally treated crosslinked polymeric composition.
8. The method of claim 6, wherein the crosslinking is by gamma irradiation.
9. The method of claim 8, wherein the gamma irradiation is at a dose of from about 1 to about 100 Mrad.
10. The method of claim 6, wherein the thermal treatment comprises remelting the crosslinked polymer.
11. The method of claim 10, wherein the remelting temperature is between the melting temperature of the irradiated polymer to about 160°C above the melting temperature of the irradiated polymer.
12. The method of claim 6, wherein the resulting polymeric composition possesses one or more of the following characteristics: degree of swelling of between about 1.7 to about 5.3; molecular weight between crosslinks of between about 400 to about 8400 g/mol; and a gel content of between about 95 to about 99 %.
13. The method of claim 6, wherein the thermal treatment comprises annealing the crosslinked polymer.
14. The method of claim 13, wherein the annealing temperature is from about 90°C below to about 1°C below the melting temperature of the irradiated polymer.
15. A polymeric composition made from the steps of:
(a) crosslinking a starting polymer in a solid state to form a crosslinked polymer; and (b) subjecting the crosslinked polymer to thermal treatment.
16. The polymeric composition of claim 15, further comprising the step of removing the most oxidized surface of the crosslinked polymeric composition.
11. The polymeric composition of claim 15, wherein the crosslinking is by gamma irradiation.
18. The polymeric composition of claim 17, wherein the gamma irradiation is at a dose of from about 1 to about 100 Mrad.
19. The polymeric composition of claim 15, wherein the thermal treatment comprises remelting the crosslinked polymer.
20. The polymeric composition of claim 19, wherein the remelting temperature is between the melting temperature of the irradiated polymer to about 160°C above the melting temperature of the irradiated polymer.
21. The polymeric composition of claim 15, wherein the thermal treatment comprises annealing the crosslinked polymer.
22. The polymeric composition of claim 21, wherein the annealing temperature is between about 90°C below to about 1°C
below the melting temperature of the irradiated polymer.
23. A product made by the process of:
(a) crosslinking a preformed polymeric composition in a solid state;
(b) subjecting the crosslinked polymeric composition to thermal treatment; and (c) fashioning the product from the crosslinked polymeric composition.
24. The product of claim 23, further comprising the step of removing the most oxidized surface of the crosslinked polymer.
25. The product of claim 24, wherein the product is an in vivo implant.
26. A method for determining an optimal radiation dose and thermal treatment for treating a polymer to increase its wear resistance, when made into a desired product, while maintaining its desirable physical and/or chemical properties, the method comprises the steps of:
(a) irradiating the polymer in the solid state over a range of radiation doses likely to produce the desirable wear resistance and physical and/or chemical properties;
(b) remelting the polymer;
(c) correlating the radiation doses with the wear rate of the desired product made from the irradiated remelted polymer using actual or simulated wear conditions for the desired product;
(d) correlating the radiation doses with each of the physical and/or chemical properties of the desired product made from the irradiated remelted polymer using actual or simulated wear conditions for the desired product;
(e) comparing the correlations in steps (c) and (d) to determine the optimal radiation dose which will produce a desirable wear rate while maintaining the desirable physical and/or chemical properties, is such a radiation dose is arrived at, use this optimal radiation dose for future treatment of the polymer;
(f) if the optimal radiation dose cannot be arrived at in step (e), then determining a dose that would produce a desirable wear rate based on the correlation of step (c) and annealing instead of remelting the polymer which has been irradiated to said dose;
(g) correlating the physical and/or chemical properties of the desired product made from the irradiated and annealed polymer, using actual or simulated wear conditions for the desired product,with different annealing times and temperatures;
(h) determining an annealing temperature and time which will provide the desirable wear rate and physical and/or chemical properties, if this is possible, then use the radiation dose and annealing conditions determined at this step for future treatment of the polymer;
(i) step (h) does not provide the desirable wear rate and physical and/or chemical properties, then apply a lower radiation dose and repeat steps (c) to (i) or (h) until the optimal radiation dose and annealing conditions are determined or the steps confirm that no optimal radiation dose and annealing conditions can be obtained for the desired wear rate and physical and/or chemical properties.
27. The method of claim 26, wherein the irradiation is gamma irradiation between a range or about 1 to 100 Mrad; the remelting temperature is between the melting temperature of the irradiated polymer to about 160°C above the melting temperature of the irradiated polymer; and the annealing temperature is between about 90°C below to about 1°C below the melting temperature of the irradiated polymer.
28. A polymer produced by irradiation and thermal treatment, wherein the radiation dose and remelting or annealing conditions are determined by the method of claim 26.
29. An in vivo implant made from the polymer of claim 28, wherein the most oxidized surface of the polymer is removed.
30. A process for treating a polymer, wherein the process employs radiation dose and remelting or annealing conditions determined by the steps of claim 26.
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