Claims for Patent: 7,723,108

Summary for Patent: 7,723,108

Title:	Soft tissue processing
Abstract:	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.
Inventor(s):	Truncale; Katherine Gomes (Hillsborough, NJ), Cartmell; Jeffrey Stuart (Freehold, NJ), Syring; Carina (Basel, CH), Von Versen; Rudiger (Basdorf, DE), Ngo; Manh-Dan (Rochester, NY)
Assignee:	Musculoskeletal Transplant Foundation (Edison, NJ)
Application Number:	11/375,026
Patent Claims:	1. A method for the treatment of human donor dermis to prepare the same for implantation into a human comprising: (a) thawing frozen donor dermis and decellularizing the donor dermis; (b) inspecting the donor dermis for defects; (c) trimming the donor dermis for processing; (d) sterilizing the trimmed donor dermis in a vacuum with a soak in a sterilization solution consisting essentially of propylene glycol, ethanol, water and peracetic acid, (e) rinsing the material contained in the soak from the donor dermis; (f) cutting the treated donor dermis to a specific size; (g) immersing the cut donor dermis in ethanol; and (h) packaging the ethanol-soaked donor dermis in a sealed package, wherein the donor dermis is flexible upon removal from the package. 2. The method as claimed in claim 1 wherein after (f), the cut dermis is perforated with a plurality of spaced apertures. 3. The method as claimed in claim 1, further comprising adding at least one protease inhibitor during decellularization of the donor soft tissue, wherein the protease inhibitor is selected from the group consisting of: Aminoethylbenzenesulfonyl fluoride HCL (Serine Proteases), Aprotinin (broad spectrum, serine proteases), Protease Inhibitor E-64 (Cysteine Proteases), Leupeptin, Hemisulfate Cysteine Proteases and trypsin-like proteases, Pepstatin A (Aspartic Proteases), and Marmistat (MMP2). 4. The method of claim 1, wherein prior to sterilizing the dermis in (d), decellularizing the dermis comprises: (i) removing the epidermal layer from skin tissue; (ii) soaking the remaining skin tissue in 1M NaCl from 1.5 to 48 hours; (iii) rinsing the NaCl-soaked skin tissue with sterile water a plurality of times to remove the NaCl; (iv) soaking the treated skin tissue in 0.1% Triton X-100 detergent from 1.5 to 48 hours; and, (v) rinsing the Triton X-100 detergent-soaked skin tissue with sterile water to remove the detergent to an acceptable level. 5. The method of claim 4, further comprising adding at least one protease inhibitor during decellularization of the dermis, wherein the protease inhibitor is selected from the group consisting of: Aminoethylbenzenesulfonyl fluoride HCL (Serine Proteases), Aprotinin (broad spectrum, serine proteases), Protease Inhibitor E-64 (Cysteine Proteases), Leupeptin, Hemisulfate Cysteine Proteases and trypsin-like proteases, Pepstatin A (Aspartic Proteases), and Marmistat (MMP2). 6. The method of claim 1, wherein the soft donor tissue is soaked in the sterilization solution for about 4 to 8 hours. 7. The method of claim 4, wherein the dermis is soaked in the sterilization solution for about 4 to 8 hours. 8. Dermis tissue prepared according to the method of claim 1. 9. Dermis prepared according to the method of claim 4. 10. The method of claim 1, wherein the sterilization solution in (d) comprises 35% peracetic acid. 11. The method of claim 4, wherein the remaining skin tissue in (ii) is soaked in 1M NaCl from 12-48 hours. 12. The method of claim 4, wherein the treated skin tissue in (iv) is soaked in 0.1% Triton X-100 from 24-48 hours. 13. The donor soft tissue of claim 8, wherein the tissue is less than 1.0 mm thick. 14. The method of claim 1, wherein prior to sterilizing the dermis in (d), decellularizing the dermis comprises: (i) removing the epidermal layer from skin tissue; (ii) soaking the remaining skin tissue in 1M NaCl and 0.1% Triton X-100 detergent from 1.5 to 48 hours; (iii) rinsing the skin tissue from (ii) with sterile water a plurality of times to remove the NaCl and detergent to an acceptable level.

Details for Patent 7,723,108

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	TRASYLOL	aprotinin	Injection	020304	12/29/1993		2025-03-16
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2025-03-16