Methods for making oxidation resistant polymeric material
The present invention relates to methods for making oxidation resistant medical devices that comprise polymeric materials, for example, ultra-high molecular weight polyethylene (UHMWPE). The invention also provides methods of making antioxidant-doped medical implants, for example, doping of medical devices containing cross-linked UHMWPE with vitamin E by diffusion and materials used therein.
1. A method of making an oxidation resistant and wear resistant polymeric blend comprising the steps of:
a) mixing a polymeric material with an antioxidant in the absence of a supercritical fluid, thereby forming a polymeric blend;
b) consolidating the polymeric blend; and
c) irradiating the consolidated polymeric blend with electron-beam radiation at a dose rate of about 5 to about 3,000 Mrad/minute to a total absorbed dose of about 50 kGy to about 1000 kGy, wherein the polymeric blend is irradiated at an elevated temperature that is above room temperature and below the melting point of the polymeric material and is not melted after irradiation, thereby forming an oxidation resistant and wear resistant polymeric blend.
2. The method of claim 1 , wherein the polymeric blend is irradiated at a dose rate of about 7 to about 25 Mrad/minute.
3. The method of claim 1 , wherein the polymeric blend is irradiated at a dose rate of about 20 Mrad/minute.
4. The method of claim 1 , wherein the polymeric blend is irradiated to a total absorbed dose of about 50 kGy, about 65 kGy, about 75 kGy, about 100 kGy, about 150, kGy, about 200 kGy, about 300 kGy, about 400 kGy, about 500 kGy, about 600 kGy, about 700 kGy, about 800 kGy, about 900 kGy, about 1000 kGy, or above 1000 kGy.
5. The method of claim 1 , wherein the polymeric blend is irradiated to a total absorbed dose of about 5 to about 100 Mrad.
6. The method of claim 1 further comprising machining the oxidation resistant and wear resistant polymeric blend, thereby forming a medical implant.
7. The method of claim 6 , wherein the medical implant is sterilized by ionizing radiation, gas plasma, or ethylene oxide.
8. The method of claim 6 , wherein the medical implant is packaged and sterilized.
9. The method of claim 1 , wherein the polymeric material is selected from the group consisting of a low-density polyethylene, high-density polyethylene, linear low-density polyethylene, and ultra-high molecular weight polyethylene (UHMWPE), or a mixture thereof.
10. The method of claim 1 , wherein the polymeric material is ultra-high molecular weight polyethylene (UHMWPE).
11. The method of claim 1 , wherein the polymeric material is polymeric resin powder, polymeric flakes, polymeric particles, or a mixture thereof.
12. The method of claim 1 , wherein the polymeric blend is cross-linked by irradiation in an inert atmosphere, wherein the inert atmosphere contains gas selected from the group consisting of nitrogen, argon, helium, neon, or the like, or a combination thereof.
13. The method of claim 1 , wherein the polymeric blend is cross-linked by irradiation in a vacuum.
14. The method of claim 1 , wherein the polymeric blend is irradiated at a temperature between about above the room temperature and about 135° C.
15. The method of claim 1 , wherein the antioxidant is vitamin E, and wherein the vitamin E is used at a concentration of 0.1% (w/v).
16. The method of claim 1 , wherein the vitamin E is used at a concentration of 0.3% (w/v), 10% (w/v), or 50% (w/v).