Antioxidant doping of crosslinked polymers to form non-eluting bearing components

Patent metadata

Field	Value
Publication number	US-9421104-B2
Application number	US-201414171237-A
Country	US
Kind code	B2
Filing date	Feb 3, 2014
Priority date	Jul 27, 2007
Publication date	Aug 23, 2016
Grant date	Aug 23, 2016

Abstract

Methods provide a non-eluting antioxidant doped UHMWPE in the form of an implant bearing component. The process includes the steps of: (a) providing a preform; (b) irradiating the preform with γ-irradiation to crosslink the UHMWPE; (c) doping the crosslinked preform by exposing it to an antioxidant composition at a temperature below the melting point of the UHMWPE; (d) removing the doped material from contact with the antioxidant composition; and then (e) annealing by heating the doped material at a temperature above 30° C. and below the melting point of the UHMWPE; followed by (f) making an implant bearing component from the doped material, wherein at least 1 mm but no more than about 15 mm of material are removed to make the component.

First claim

We claim:

1. A non-eluting antioxidant doped UHMWPE bearing component manufactured by a process comprising steps of:
(a) providing a UHMWPE preform;
(b) irradiating the preform at a dose of 5 to 20 MRad of gamma irradiation;
(c) after the irradiating, doping the preform by exposure to an antioxidant composition comprising α-tocopherol at a temperature greater than 30° C. and below the crystalline melting point of the UHMWPE preform, and then removing the doped UHMWPE preform from exposure to the antioxidant composition;
(d) annealing the doped preform at a temperature greater than 30° C. and below the melting point of the doped preform;
(e) machining the preform to the shape of the bearing component, wherein from 1 to 15 mm of material is removed from the preform to make the component; and
(f) packaging and sterilizing the bearing component, wherein the vitamin E index throughout the bearing component is 0.01 or greater, and 0.2 or less, wherein the vitamin E index is determined from a Fourier transform infrared spectrum of the bearing component as the ratio of the area of the α-tocopherol peak at 1245-1275 cm −1 to the area of the polyethylene peak at 1850-1985 cm −1 .

2. A bearing component according to claim 1 , made by irradiating the preform to a dose of approximately 10 MRad.

3. A bearing component according to claim 1 , wherein the vitamin E index throughout the component is 0.15 or less.

4. A bearing component according to claim 1 , characterized by having a vitamin E index at the surface of the component that is less than the saturation limit of vitamin E in the component at body temperature.

5. A medical implant bearing component made of irradiation-crosslinked UHMWPE comprising post-irradiative-crosslinking added vitamin E, wherein the vitamin E index of the bearing component is at least 0.01 throughout its volume and the vitamin E index at the outer surface of the bearing component is less than or equal to 0.2, wherein the vitamin E index is determined from a Fourier transform infrared spectrum of the bearing component as the ratio of the area of the α-tocopherol peak at 1245-1275 cm −1 to the area of the polyethylene peak at 1850-1985 cm −1 .

6. The bearing component according to claim 5 , wherein the vitamin E index of the bearing component is at least 0.02 throughout its volume.

7. The bearing component according to claim 5 , comprising a detectable level of free radicals greater than zero.

8. The bearing component according to claim 5 , wherein the oxidation index of the bearing component changes by less than 0.1 when exposed to oxygen at 70° C. for 4 weeks.

9. The bearing component according to claim 5 , wherein the bearing component is for a hip joint.

10. The bearing component according to claim 9 , wherein the bearing component is an acetabular cup.

11. The bearing component according to claim 5 , wherein the bearing component is for a knee joint.

12. The bearing component according to claim 11 , wherein the bearing component is a tibial plateau.

13. The bearing component according to claim 5 , wherein the bearing component is for an ankle joint.

14. The bearing component according to claim 5 , wherein the bearing component is for an elbow joint.

15. The bearing component according to claim 5 , wherein the bearing component is for a shoulder joint.

16. The implanting bearing component according to claim 5 , wherein the bearing component is for a spine implant.

17. The bearing component according to claim 5 , wherein the bearing component is for a temporomandibular joint.

18. The bearing component according to claim 5 , wherein the bearing component is for a finger joint.

Assignees

• Biomet Mfg Llc

Inventors

• Schroeder David W
• Freedman Jordan H

Classifications

• B29C71/02

  Thermal after-treatment {(B29C71/0063 and B29C71/0072 take precedence)} · CPC title

• B29C71/04

  by wave energy or particle radiation {, e.g. for curing or vulcanising preformed articles (during moulding, e.g. in a mould B29C35/08)} · CPC title

• B29C2071/022

  Annealing · CPC title

• A61F2/34 Primary

  Acetabular cups · CPC title

• A61F2/32

  for the hip · CPC title