Perforated submucosal tissue graft constructs

• US 5,755,791 A
• Filed: 04/05/1996
• Issued: 05/26/1998
• Est. Priority Date: 04/05/1996
• Status: Expired due to Term

• Current Assignee: Methodist Hospitals of Dallas
• Original Assignee: Methodist Hospitals of Dallas, Purdue Research Foundation (The Trustees of Purdue University (d/b/a Purdue University))
• Inventors: Badylak, Stephen F., Whitson, Bryan, Cheng, Boyle
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Black, John M.
• Application Number:
  US08/628,789
• Time in Patent Office: 781 Days
• Field of Search: 623/15
• US Class Current: 623/1.1
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• 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

Abstract

A perforated unitary multi-laminar tissue graft construct and method for preparing such construct is described. The method comprises overlapping strips of submucosa tissue with other strips of submucosal tissue, compressing at least the overlapped portions of said strips between two surfaces under conditions that allow or promote dehydration of the compressed submucosa sheets, and perforating the resulting unitary tissue graft construct. The perforated tissue graft compositions have enhanced mechanical and remodeling properties relative to non-perforated submucosal tissue grafts.

Claims

1. A unitary multi-laminate tissue graft construct comprising multiple strips of intestinal submucosa, wherein each of said multiple strips has first and second planar surfaces and each is delaminated from both the tunica muscularis and at least the luminal portion of the tunica mucosa of a warm blooded vertebrate, said graft construct formed to have a planar surface with a surface area greater than the surface area of any one planar surface of the individual strips used to form said construct, said graft further provided with a plurality of perforations that allow fluid to pass through the craft construct.

2. The graft construct of claim 1, wherein each of the perforations define a longitudinal perforation axis and each perforation is formed such that the perforation axis is not perpendicular to the planar surface.

3. The graft construct of claim 1, formed as a unitary heterolaminar graft construct.

4. The graft construct of claim 1, formed as a unitary homolaminar graft construct.

5. The graft construct of claim 1, wherein the submucosa strips are conditioned to have a strain of no more than 20%.

6. The graft construct of claim 1, wherein the perforations are uniformly distributed over the surfaces of the graft construct.

7. The graft construct of claim 1, wherein the perforations are spaced from one another at a distance of about 2 to about 20 mm.

8. The graft construct of claim 7, wherein the perforations are uniformly distributed over the surfaces of the graft construct.

9. The graft construct of claim 1, wherein the perforations are of substantially uniform size and have a diameter of about 0.5 to 3 mm.

10. The tissue graft construct of claim 1, wherein the strips of intestinal submucosa tissue consist essentially of the tunica submucosa, the muscularis mucosa and the stratum compactum of the tunica mucosa.

11. The tissue graft construct of claim 1, wherein the strips of submucosa tissue forming said construct are orientated so that the construct has substantially isotropic properties.