Soft tissue processing
View Patent ↗The present invention is a process for preparing soft tissue such as tendons, ligaments, cartilage, fascia, dermis, human valves and human veins for implant in a human and removes cellular components and forms an decellular matrix having as major components collagens and elastins while sterilizing the tissue. The process comprises the following steps: (1) isolating from a suitable donor a desired soft tissue sample of the biological material; (2) processing and decellularizing the soft tissue including inspection for visual defects, trimming and soaking the tissue in a detergent depending on whether the tissue is fascia or dermis and rinsing same with sterile water; (3) sterilizing the soft tissue in a vacuum and soaking the tissue in an antibiotic composition or peracetic acid depending on whether the soft tissue is fascia or dermis and rinsing same; (4) processing the tissue by cutting the tissue to size and perforating the tissue; and (5) dipping the tissue in 70% ethanol and packaging the tissue.
1. A method of preparing donor dermis suitable for implantation into a human, comprising:
(a) decellularizing the donor dermis;
(b) treating the donor dermis with a detergent for a period of time ranging from about 1.5 to 48 hours;
(c) treating the donor dermis in a sterilization solution for about 4 to 8 hours, wherein the sterilization solution consists essentially of 35% peracetic acid, ethanol, propylene glycol, and water, and
(d) packaging the donor dermis in a sealed package.
2. The method of claim 1 , wherein the donor dermis is lyophilized prior to packaging in (d).
3. The method of claim 2 , wherein the donor dermis is frozen prior to lyophilization.
4. The method of claim 1 , wherein the donor dermis is rinsed subsequent to sterilization in (c) and immersed in ethanol prior to packaging in (d).
5. The method of claim 4 , wherein the ethanol in which the donor dermis is immersed prior to packaging in (d) is 70% ethanol.
6. The method of claim 1 , wherein in (a), the donor dermis is placed in a solution of NaCl for a period of time ranging from about 1.5 to 48 hours.
7. The method of claim 1 , wherein in (a), a protease inhibitor is added.
8. The method of claim 7 , wherein the protease inhibitor is selected from the group consisting of: Aminoethylbenzenesulfonyl fluoride HCL, Aprotinin, Protease Inhibitor E-64, Leupeptin, Hemisulfate, trypsin-like proteases, Pepstatin A, and Marmistat.
9. The method of claim 1 , wherein the detergent in (b) is Triton X-100.
10. The method of claim 1 , wherein the sterilization solution in (c) consists essentially of 35% peracetic acid, 95% ethanol, propylene glycol, and water.
11. The method of claim 1 wherein prior to packaging in (d), the dermis is perforated with a plurality of spaced apertures.
12. The method of claim 1 , wherein the donor dermis is frozen donor dermis that has been thawed prior to decellularizing in (a).
13. The method of claim 1 , comprising treating the donor dermis in (b) with a detergent for a period of time ranging from about 24 to 48 hours.
14. The method of claim 6 , wherein in (a), the donor dermis is placed in a solution of NaCl for a period of time ranging from about 12 to 48 hours.