Stomach submucosa derived tissue graft

• US 6,099,567 A
• Filed: 05/04/1999
• Issued: 08/08/2000
• Est. Priority Date: 12/10/1996
• Status: Expired due to Term

• Current Assignee: Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Original Assignee: Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Inventors: Tullius, Robert S., Badylak, Stephen F., Voytik-Harbin, Sherry L., Brightman, Andrew O.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/297,624
• Time in Patent Office: 462 Days
• Field of Search: 623/11, 623/13, 424/551
• US Class Current: 623/11.11
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A tissue graft composition comprising stomach submucosal tissue delaminated from both the luminal portion of the tunica mucosa and the smooth muscle layers of the muscularis externa of a stomach of a warm blooded vertebrate is described. The graft composition can be or implanted into a host to replace or support damaged or diseased tissues.

Claims

1. A composition capable of inducing the formation of endogenous tissue when implanted at a site in need of endogenous tissue growth comprising stomach submucosa delaminated from both the luminal portion of the tunica mucosa and the smooth muscle layers of the muscularis externa of a stomach of a warm blooded vertebrate.

2. The composition of claim 1 wherein the stomach submocosa is fluidized.

3. The composition of claim 1 wherein the stomach submucosa is digested with an enzyme for a period of time sufficient to solubilize the stomach submucosa and provide a substantially homogenous solution.

4. The composition of claim 2, wherein the stomach submucosais dried and in powder form.

5. The composition of claim 1 formed into a cylinder having a predetermined luminal diameter and sutured along the length of the cylinder.

6. The composition of claim 1 conditioned to reduce the strain of the isolated stomach submucosa for use as a connective tissue substitute.

7. The composition of claim 6 wherein the stomach submucosa is conditioned by stretching to produce a graft construct longer in at least one dimension than the stomach submucosa from which it is formed.

8. The use of stomach submucosa for the preparation of a tissue graft construct useful for inducing endogenous tissue growth when implanted in warm-blooded vertebrates, said stomach submucosa being delaminated from both the luminal portion of the tunica mucosa and the smooth muscle layers of the muscularis externa of a stomach of a warm blooded vertebrate.

9. The use according to claim 8 wherein the stomach submucosa is in fluidized form.

10. The use according to claim 8 wherein the stomach submucosa is in powder form.

11. A method for inducing the formation of endogenous tissue at a site in need of endogenous tissue growth in a warm blooded vertebrate, said method comprising contacting said site with a graft composition comprising stomach submucosa in an amount effective to induce endogenous tissue growth at the site the composition is administered.

12. The method of claim 11, wherein the graft composition is fluidized and is administered by injection into the warm-blooded vertebrate.

13. The method of claim 12, wherein the graft composition is administered by surgically implanting the composition into the warm-blooded vertebrate.