Peracetic acid sterilization of collagen or collagenous tissue

• US 5,460,962 A
• Filed: 01/04/1994
• Issued: 10/24/1995
• Est. Priority Date: 01/04/1994
• Status: Expired due to Term

• Current Assignee: Organogenesis Inc. (Organogenesis Holdings, Inc.)
• Original Assignee: Organogenesis Inc. (Organogenesis Holdings, Inc.)
• Inventors: Kemp, Paul D.
• Primary Examiner(s): Knode, Marian C.
• Assistant Examiner(s): Saucier, S.
• Application Number:
  US08/177,618
• Time in Patent Office: 658 Days
• Field of Search: 435/238, 514/553, 422/28
• US Class Current: 435/238
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0215 Disinfecting agents, e.g. antimicrobials for preserving living parts
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 37/16 containing the group; Thio analogues thereof
• CPC Class Codes: A61L 2/0088 Liquid substances

Abstract

This invention is directed to the sterilization of collagen and collagenous tissue which is to be used for implantation, repair, or use in a mammalian host in the emerging field of tissue engineering. The sterilants are low concentration peracetic acid solutions in either neutral or high ionic strength that prevent or minimizes the swelling of collagen or collagenous tissue so that the sterilized tissue retains its structural integrity and bioremodelable properties.

Claims

1. A method for sterilizing collagen or collagenous tissue comprising veins, tendons, dermis, heart valves, stomach smooth muscle tissue and small intestine submucosa comprising contacting said collagen or collagenous tissue with a solution consisting essentially of peracetic acid in the concentration range of 0.02% to 1.0% and a neutralized pH of about 6.0 to about 8.0 in order to sterilize said collagen or collagenous tissue with no or a minimal amount of swelling and dissolution in comparison with use of an unneutralized peracetic acid solution.

2. The method of claim 1 wherein the peracetic acid concentration is about 0.1%.

3. A method for sterilizing collagenous tissue comprising veins, tendons, dermis, heart valves, stomach smooth muscle tissue an small intestine submucosa comprising contacting said collagen or collagenous tissue with a solution consisting essentially of peracetic acid in the concentration range of 0.02% to 1.0% and a salt concentration from about 1M to about 2M in order to sterilize said collagen or collagenous tissue with no or a minimal amount of swelling and dissolution in comparison with use of a peracetic acid solution without salt.

4. The method of claim 3 wherein the peracetic acid concentration is about 0.1%.