Bioprosthetic heart valve with semi-permeable commissure posts and deformable leaflets

• US 5,147,391 A
• Filed: 05/06/1991
• Issued: 09/15/1992
• Est. Priority Date: 04/11/1990
• Status: Expired due to Fees

• Current Assignee: Carbomedics Inc. (Snia SpA)
• Original Assignee: Carbomedics Inc. (Snia SpA)
• Inventors: Lane, Ernest
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): WILLSE, DAVID H
• Application Number:
  US07/695,851
• Time in Patent Office: 498 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.18
• 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
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A bioprosthetic heart valve comprising leaflets with free edges which do not impinge on adjacent leaflets when the leaflets are closed before being implanted and subject to body fluids and cardiac pressure cycles. Commissures supporting the leaflets have semi-permeable membranes which reduce the pressure load on the leaflets during implantation. In response to immersion in body fluids, the membranes become substantially impermeable. The leaflets can stretch in response to loads and hydration, so that the free edges mate shortly after implantation. First and second mechanisms for supporting leaflets to provide multiple effective spring constants. An inner frame supporting commissures of the valve is elastic, permitting the commissures to bend in toward the center of the prosthetic heart valve at very low loads. A relatively rigid annular support ring supports the elastic frame and provides the second spring constant mechanism. The leaflets have an uncoupled mating edge where the leaflet approach each other in the center of the valve.

Claims

1. A prosthetic heart valve comprising

a generally annular frame having a plurality of commissures joined thereto and extending generally axially therefrom and each commissure terminating at a distal end, each commissure being covered with a semipermeable membrane, said membrane becoming substantially impermeable upon immersion in body fluids;

and

valve leaflets attached to said frame and connecting adjacent commissures, said valve leaflets further comprising a free edge connecting two adjacent commissures, said free edge being convex with respect to a line connecting a junction between said free edge and one of said adjacent commissures and a junction between said free edge and the other of said adjacent commissures, and said free edge being adjacent said line so that, when the leaflets are closed and before being subjected to pressure, substantially all of each free edge is spaced away from the free edge of the adjacent leaflet, said leaflets being capable of stretching in response to pressure loads and hydration, whereby the free edges become mating.

2. The prosthetic heart valve according to claim 1 wherein said valve leaflets further comprise a fillet at each junction between said free edge and said commissure.

3. The prosthetic heart valve according to claim 1 wherein each of said commissures is radially elastic over a portion of an axial length thereof, said elastic portion being adjacent said distal end;

and wherein said heart valve further comprises

a generally annular, substantially rigid ring, said ring having commissure supports, each of said commissure supports extending along a second portion of one of said commissures, said second portion being remote from said distal end; and

means for transferring loads from said valve leaflets primarily to said elastic portions of said commissures during a first part of a cardiac cycle and primarily to said commissure supports and rigid ring during a second part of said cardiac cycle.

4. The prosthetic heart valve according to claim 3 further comprising a plurality of rigid ribs affixed to said frame and extending along at least part of said second portion of said commissures, whereby said part of said second portion of said commissures is rendered substantially rigid.

5. The prosthetic heart valve according to claim 4 wherein the load transferring means comprise a flexible material connecting at least part of an upper edge of said rigid ring and at least part of an upper edge of said frame and wherein said leaflets pass between said rigid ring and a lower edge of said frame.

6. The prosthetic heart valve according to claim 5 wherein the load transferring means further comprise a plurality of flexible sheets, each sheet connecting a top of one of said commissure supports to an adjacent commissure.

7. The prosthetic heart valve according to claim 6 wherein said annular frame comprises a flexible ribbon.

8. The prosthetic heart valve according to claim 7 wherein said ribbon has a width greater than ten times a depth of said ribbon.

9. The prosthetic heart valve according to claim 8 wherein at least part of a border of each of said valve leaflets lies between said frame and said ring.

10. The prosthetic heart valve according to claim 9 wherein said valve leaflets are attached to said frame near a first edge side of said elastic frame and wherein said border of each of said leaflets passes between said frame and said ring to a second edge of said frame.

11. The prosthetic heart valve according to claim 10 wherein said ribbon comprises a wide side at least part of which lies adjacent said annular ring and wherein said annular ring further comprises a channel adapted to mate with said wide side of said ribbon.