Cross-linked ultra-high molecular weight polyethylene for medical implant use
First Claim
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1. A method of producing an UHMWPE medical implant for use in a body comprising the steps of:
- crosslinking the UHMWPE;
annealing the UHMWPE;
machining the UHMWPE to form said implant;
wear testing the implant;
analyzing wear particles created by said step of wear testing, said step of analyzing having sufficient sensitivity to detect particles having sizes of 0.05 μ
m or less;
determining the number of particulate debris; and
selecting a crosslinking irradiation dose that exhibits the lowest number of particulate debris relative to that exhibited by non-crosslinked UHMWPE treated by all of the above steps except said crosslinking step and said selecting step, and wherein the wear particles are decreased to a particle number of less than that exhibited by non-crosslinked UHMWPE treated by all of the above steps except said crosslinking step and said selecting step.
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Abstract
The present invention relates to the prevention and decrease of osteolysis produced by wear of the ultrahigh molecular weight polyethylene (UHMWPE). Methods are disclosed for the isolation of wear particles, preparation of implants exhibiting decreased wear in comparison to conventional UHMWPE and preparation of implants that cause decreased biological response in comparison to conventional UHMWPE. The implants created by these methods are also included in the present invention.
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Citations
17 Claims
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1. A method of producing an UHMWPE medical implant for use in a body comprising the steps of:
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crosslinking the UHMWPE;
annealing the UHMWPE;
machining the UHMWPE to form said implant;
wear testing the implant;
analyzing wear particles created by said step of wear testing, said step of analyzing having sufficient sensitivity to detect particles having sizes of 0.05 μ
m or less;
determining the number of particulate debris; and
selecting a crosslinking irradiation dose that exhibits the lowest number of particulate debris relative to that exhibited by non-crosslinked UHMWPE treated by all of the above steps except said crosslinking step and said selecting step, and wherein the wear particles are decreased to a particle number of less than that exhibited by non-crosslinked UHMWPE treated by all of the above steps except said crosslinking step and said selecting step. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of producing an UHMWPE medical implant for use in a body comprising the steps of:
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crosslinking the UHMWPE;
annealing the UHMWPE;
machining the UHMWPE to form said implant;
wear testing the implant;
analyzing wear particles created by said step of wear testing, said step of analyzing having sufficient sensitivity to detect particles having sizes of less than 0.2 μ
m;
determining the number of particulate debris; and
selecting a crosslinking irradiation dose that exhibits the lowest number of particulate debris relative to that exhibited by non-crosslinked UHMWPE treated by all of the above steps except said crosslinking step and said selecting step, and wherein the wear particles are decreased to a particle number of less than that exhibited by non-crosslinked UHMWPE treated by all of the above steps except said crosslinking step and said selecting step.
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Specification