Large area submucosal tissue graft constructs and method for making the same

• US 5,885,619 A
• Filed: 09/16/1997
• Issued: 03/23/1999
• Est. Priority Date: 04/07/1995
• Status: Expired due to Term

• Current Assignee: Methodist Hospitals of Dallas, Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Original Assignee: Methodist Hospitals of Dallas, Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Inventors: Patel, Umesh H., Hiles, Michael C., Whitson, Bryan, Cheng, Boyle, Kokini, Klod, Badylak, Stephen F.
• Primary Examiner(s): Witz, Jean C.
• Application Number:
  US08/931,299
• Time in Patent Office: 553 Days
• Field of Search: 424/551, 623/11, 623/13
• US Class Current: 424/551
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61K 35/38 Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A unitary heterolaminar tissue graft construct is prepared by fusing partially overlapped strips or sheets of submucosa tissue. The submucosa components are fused by compressing at least the overlapped positions of said strips between two surfaces under conditions that allow or promote dehydration of the compressed submucosa sheets. Three dimensional graft constructs can be prepared by using complementary non-planar compressive surfaces.

Claims

1. A method for forming a unitary tissue graft construct consisting essentially of multiple strips of submucosal tissue, said construct having a surface area greater than any one of the individual strips used to form said construct, said method comprising the steps of overlapping a portion of one strip of submucosal tissue with a portion of a second strip of submucosal tissue and compressing at least the overlapped portions between two surfaces, at least one of which is water permeable, under dehydrating conditions.

2. The method of claim 1, further comprising the step of applying a vacuum to the submucosal tissue during compression thereof.

3. The method of claim 2, wherein the applied vacuum coacts with the two surfaces to compress the submucosal tissue.

4. The method of claim 1, further comprising the step of applying heat to the submucosal tissue during compression thereof.

5. The method of claim 1, wherein both surfaces are water permeable.

6. The method of claim 1, wherein the two surfaces are complementary nonplanar surfaces wherein compression between the two surfaces produces a tissue graft construct shaped to conform to those surfaces.

7. The method of claim 1, wherein the submucosal tissue is intestinal submucosa comprising the tunica submucosa delaminated from both the tunica muscularis and at least the luminal portion of the tunica mucosa.

8. The method of claim 1 farther comprising the step of moving a compressing force across the surface of the construct to remove air and bulk water trapped between the overlapped strips before compressing the overlapped portions between the two surfaces.

9. The method of claim 8, wherein the two surfaces comprise a pair of opposed rollers and the overlapped strips are passed between the rollers.

10. A large area multi-laminate sheet of submucosal tissue comprising multiple strips of intestinal submucosal tissue delaminated from both the tunica muscularis and at least the lurninal portion of the tunica mucosa of a warm blooded vertebrate, said strips having an abluminal surface and a lurinal surface, wherein each strip is partially overlapped with at least one additional strip of submucosal tissue and the the luminal surface of each strip is in contact with the abluminal surface of at least one additional strip of submucosal tissue, said multiple strips of intestinal submucosa tissue being fused to one another by compressing the strips under dehydrating conditions to form a sheet of submucosal tissue having a surface area greater than any one of the individual strips used to form said construct.