Methods for making oxidation-resistant cross-linked polymeric materials
The present invention relates to methods for making cross-linked oxidation-resistant polymeric materials and preventing or minimizing in vivo elution of antioxidant from the antioxidant-containing polymeric materials. The invention also provides methods of doping polymeric materials with a spatial control of cross-linking and antioxidant distribution, for example, vitamin E (α-Tocopherol), and methods for extraction/elution of antioxidants, for example, vitamin E (α-tocopherol), from surface regions of antioxidant-containing polymeric materials, and materials used therewith also are provided.
1. An interlocked hybrid material comprising an oxidation-resistant cross-linked polymeric material, wherein the interlocked hybrid material is made by a method comprising the steps of:
a) blending a polymeric material with an antioxidant, wherein a first portion of the polymeric material is contacted with a concentration of an antioxidant, a second portion of the polymeric material is contacted with another concentration of the antioxidant, and a third portion of the polymeric material is contacted with another concentration of the antioxidant, thereby allowing a spatial distribution of the antioxidant-rich and antioxidant-poor regions;
b) compression molding the spatially distributed antioxidant blended polymeric material to another piece or a medical implant by layering the third portion of the polymeric material, the second portion of the polymeric material, and the first portion of the polymeric material, thereby forming an interface and an interlocked hybrid material; and
c) irradiating the interlocked hybrid material containing the spatially distributed antioxidant with ionizing radiation, thereby forming an interlocked hybrid material having an oxidation-resistant cross-linked polymeric material containing spatially controlled cross-linking and antioxidant distribution.
2. The interlocked hybrid material according to claim 1 , wherein the blended polymeric material in the first and second portions contain same concentrations of the antioxidant.
3. The interlocked hybrid material according to claim 1 , wherein the blended polymeric material in the second and third portions contain same concentrations of the antioxidant.
4. The interlocked hybrid material according to claim 1 , wherein the blended polymeric material in the first and third portions contain different concentrations of the antioxidant.
5. The interlocked hybrid material according to claim 1 , wherein the blended polymeric material in the first and third portions contain same concentrations of the antioxidant.
6. The interlocked hybrid material according to claim 5 , wherein the irradiated interlocked hybrid material contains spatially distributed antioxidant and forms an interlocked hybrid material having an oxidation-resistant cross-linked polymeric material having a spatially controlled cross-linking and antioxidant distribution.
7. The interlocked hybrid material according to claim 1 , wherein the another piece onto which the resins, flakes or powders are consolidated is a porous metal.
8. The interlocked hybrid material according to claim 1 , wherein the irradiation is performed when the interlocked hybrid material is at a temperature above room temperature and below the melting point of the polymeric material, wherein the temperature is between about 40° C. and about 135° C.
9. The interlocked hybrid material according to claim 1 , wherein the interlocked hybrid material is a direct compression molded implant.
10. The interlocked hybrid material according to claim 1 , wherein the antioxidant is vitamin E.
11. The interlocked hybrid material according to claim 1 , wherein the polymeric material is polymeric resin powder, polymeric flakes, polymeric particles, or the like, or a mixture thereof.
12. A medical implant comprising the interlocked hybrid material according to claim 1 , wherein the oxidation-resistant interlocked hybrid material is machined, thereby forming oxidation-resistant medical implant.
13. The medical implant according to claim 12 , wherein the oxidation-resistant medical implant having a spatially controlled crosslinking and antioxidant distribution is packaged and sterilized.