Biocompatible tissue graft material for implant and method of making
This invention provides an antigen-free and immunologically inert tissue graft material and methods of preparing and using these tissue graft materials.
1. A method of preparing an absorbable remodelable graft material that is substantially hair-free and immunologically inert comprising the steps of:
(a) soaking an animal tissue in a bleach solution;
(b) washing the animal tissue in a detergent solution;
(c) rinsing the animal tissue to remove the detergent solution;
(d) configuring the animal tissue to a desired physical form and thickness;
(e) soaking the animal tissue in an iodophor solution;
(f) rinsing the animal tissue to remove the iodophor solution;
(g) soaking the animal tissue in a hypertonic solution;
(h) rinsing the animal tissue to remove the hypertonic solution;
(i) agitating the animal tissue in a mixture of a caustic and peroxide solution; and
(j) rinsing the animal tissue in water to remove the mixture of caustic and peroxide solution to provide the absorbable remodelable graft material that is a collagenic extra cellular matrix from which substantially all bioreactive cellular material is removed and is substantially hair-free.
2. The method of claim 1 , wherein the step of soaking the animal tissue in a hypertonic solution further comprises the steps of:
soaking the animal tissue in a series of increasingly hypertonic solutions; and
rinsing the animal tissue after each soaking in a hypotonic solution to remove the hypertonic solution.
3. The method of claim 1 , wherein the mixture of a caustic and peroxide solution comprises a sodium hydroxide concentration between about 0.1-5N and a peroxide concentration between about 0.1-20 wt %.
4. The method of claim 1 , wherein the mixture of a caustic and peroxide solution comprises a sodium hydroxide concentration between about 0.25-3N and a peroxide concentration between about 0.75-10 wt %.
5. The method of claim 1 , wherein the graft material is soaked in a saline solution after step (j).
6. The method of claim 1 , wherein the graft material is chemically cross-linked to modify its absorption rate, after step (j).
7. The method of claim 6 , wherein the graft material is chemically cross-linked with a cross-linking agent at a concentration of about 0.01 to about 5 percent.
8. The method of claim 1 wherein the animal tissue is from an autologous, heterologous or allogenic source and derived from porcine, bovine, equine, rodent or human tissue.
9. The method of claim 1 , wherein the animal tissue comprises porcine derma tissue.