Porcine small intestine submucosa leaflet material

Patent metadata

Field	Value
Publication number	US-10195024-B2
Application number	US-201615272772-A
Country	US
Kind code	B2
Filing date	Sep 22, 2016
Priority date	Oct 7, 2015
Publication date	Feb 5, 2019
Grant date	Feb 5, 2019

Abstract

A prosthetic heart valve provided herein can include a porcine small intestine submucosa (P-SIS) tissue leaflet. The P-SIS tissue can include multiple stacked layers that are tensioned and cross-linked to form a material having a thickness of between 50 microns and 0.33 mm. In some cases, a prosthetic heart valve can include a plurality of leaflets secured together and retained within the expandable tubular member.

First claim

What is claimed is:

1. A prosthetic heart valve comprising a plurality of leaflets secured together and retained within an expandable tubular member, each leaflet comprising a chemically cross-linked porcine small intestine submucosa tissue;
wherein the chemically cross-linked porcine small intestine submucosa tissue is chemically cross-linked while under tension.

2. The prosthetic heart valve of claim 1 , wherein the porcine small intestine submucosa tissue includes multiple layers of P-SIS tissue.

3. The prosthetic heart valve of claim 2 , wherein the porcine small intestine submucosa tissue has a total thickness of between 50 microns and 0.33 mm.

4. The prosthetic heart valve of claim 1 , wherein the porcine small intestine submucosa tissue was lyophilized and rehydrated.

5. The prosthetic heart valve of claim 1 , wherein the porcine small intestine submucosa tissue has a moisture content of between 75% and 85%.

6. The prosthetic heart valve of claim 1 , wherein the porcine small intestine submucosa tissue has an ultimate tensile strength of between 2 MPa and 10 MPa.

7. The prosthetic heart valve of claim 1 , wherein the porcine small intestine submucosa tissue has a modulus of between 16.5 and 42.5.

8. The prosthetic heart valve of claim 1 , wherein the porcine small intestine submucosa tissue has a percent elongation at 1 MPa of between 5% and 10%.

9. The prosthetic heart valve of claim 1 , wherein the porcine small intestine submucosa tissue has an elongation to break at between 25% and 47%.

10. The prosthetic heart valve of claim 1 , wherein the chemically cross-linked porcine small intestine submucosa tissue is bi-axially oriented.

11. The prosthetic heart valve of claim 1 , wherein the tissue is cross-linked by submerging the porcine small intestine submucosa tissue in a solution of between 0.1 and 1.5 wt % glutaraldehyde for at least 10 minutes.

12. The prosthetic heart valve of claim 11 , wherein the tissue is cross-linked by submerging the porcine small intestine submucosa tissue in a solution of between 0.5 and 1.0 wt % glutaraldehyde for at least 30 minutes.

13. The prosthetic heart valve of claim 11 , wherein the tissue is cross-linked by submerging the porcine small intestine submucosa tissue in a solution of between 0.5 and 0.7 wt % glutaraldehyde for at least 2 hours.

Assignees

• Boston Scient Scimed Inc

Inventors

• Anderson-Cunanan Crystal Marie
• Fazackerley Katherine Cora

Classifications

• A61L2430/20

  for reconstruction of the heart, e.g. heart valves · CPC title

• A61L27/3691

  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 title

• A61L27/3687

  characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents · CPC title

• A61F2/2415 Primary

  Manufacturing methods · CPC title

• A61L27/3629 Primary

  Intestinal tissue, e.g. small intestinal submucosa · CPC title