Biologically covered heart valve prosthesis

• US 6,610,088 B1
• Filed: 05/03/2000
• Issued: 08/26/2003
• Est. Priority Date: 05/03/2000
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/563,565
• Time in Patent Office: 1,210 Days
• Field of Search: 623/2.14, 623/2.13, 623/2.15, 623/2.16, 623/2.12, 623/2.38, 623/2.4, 623/2.41, 623/2.42
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14

Abstract

A system and method are disclosed for covering a heart valve prosthesis with biological tissue, such as pericardium. In one aspect, the prosthesis includes a stent that is covered with a fabric material. A heart valve is mounted within the stent, such as by sutures securing the heart valve to the fabric covering. One or more sheets of biological tissue are applied to the stented prosthesis so as to cover exposed areas of the fabric material.

Claims

1. A heart valve prosthesis comprising:

a stent having an annular base portion and a plurality of stent posts extending therefrom, the stent having a fabric covering;

heart valve mounted within the stent to define a stented valve having exteriorized fabric covering;

at least one sheet of biological tissue covering the exteriorized fabric covering of the stented valve; and

a fabric implantation flange extending radially from the stent base portion, the at least one sheet of biological tissue covering the fabric implantation flange, whereby no fabric covering remains exposed.

2. A heart valve prosthesis as set forth in claim 1, wherein the implantation flange has inflow and outflow sides, the at least one sheet of biological tissue including a pair of annular sheets of biological tissue which respectively cover the inflow and outflow sides of the implantation flange.

3. A heart valve prosthesis as set forth in claim 2, wherein the annular sheet of biological tissue covering the outflow side of the implantation flange has an inner diameter that approximates an outer diameter of the fabric-covered stent near the outflow side of the implantation flange.

4. A heart valve prosthesis as set forth in claim 3, wherein the annular sheet of biological tissue covering the inflow side of the implantation flange has an inner diameter commensurate with a diameter associated with an inflow annulus at the juncture between the heart valve and the fabric-covered stent.

5. A heart valve prosthesis as set forth in claim 2, wherein the stent posts include an exterior portion, the at least one sheet of biological tissue further including a plurality of patches, each of the patches being dimensioned and configured to cover exposed fabric on the exterior portion of a respective one of the stent posts.

6. A heart valve prosthesis as set forth in claim 1, wherein the biological tissue further comprises animal pericardium.

7. A heart valve prosthesis as set forth in claim 6, wherein the animal pericardium comprises at least one of porcine pericardium, bovine pericardium, and equine pericardium.

8. A heart valve prosthesis, comprising:

a support having an inflow annulus and an outflow end;

a valve supported within an interior portion of the support to facilitate a substantially unidirectional flow of blood through the prosthesis;

fabric material that extends around at least a portion of the support and around the valve, the fabric material further comprises an implantation flange that extends around the support at a location spaced from the outflow end, the at least one sheet of biological material covering the implantation flange; and

at least one sheet of biological material around the valve and the stent to cover exposed portions of the fabric material.

9. The heart valve prosthesis of claim 8, wherein the at least one sheet of biological tissue further covers the inflow annulus.

10. The heart valve prosthesis of claim 8, wherein the implantation flange has inflow and outflow sides, the at least one sheet of biological tissue including a pair of annular sheets of biological tissue that respectively cover the inflow and outflow sides of the implantation flange.

11. The heart valve prosthesis of claim 10, wherein the annular sheet that covers the inflow side of the implantation flange has an inner diameter substantially commensurate with a diameter associated with an inflow annulus at the juncture between the heart valve and the fabric-covered stent, such that the annular sheet that covers the inflow side of the implantation flange also covers the inflow annulus of the support.

12. The heart valve prosthesis of claim 8, wherein the valve further comprises a natural tissue heart valve having leaflets that are moveable between open and closed conditions to facilitate substantially unidirectional flow of blood through the prosthesis.

13. The heart valve prosthesis of claim 8, wherein the support further comprises a stent in which the natural tissue heart valve is mounted.