Bioprosthetic heart valve with elastic commissures

• US 5,037,434 A
• Filed: 04/11/1990
• Issued: 08/06/1991
• Est. Priority Date: 04/11/1990
• Status: Expired due to Term

• Current Assignee: Carbomedics Inc. (Snia SpA)
• Original Assignee: Carbomedics Inc. (Snia SpA)
• Inventors: Lane, Ernest
• Primary Examiner(s): Shay, Randy Citrin
• Application Number:
  US07/508,275
• Time in Patent Office: 482 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A bioprosthetic heart valve comprising 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. An attachment system for sewing bioprosthetic leaflets to the frame and clamping the leaflets between the frame and the annular ring minimizes stress risers in the leaflets. The leaflets have an uncoupled mating edge where the leaflets meet in the center of the valve. The uncoupled portions of the leaflets permit the leaflets to roll by each other.

Claims

1. A prosthetic heart valve comprising

a generally annular elastic frame having a plurality of commissures extending generally axially and each commissure terminating at a distal end, each of said commissures being radially elastic over a portion of an axial length thereof, said elastic portion being adjacent said distal end;

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;

valve leaflets attached to said frame and connecting adjacent commissures; 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.

2. The prosthetic heart valve according to claim 1 further comprising a plurality of rigid ribs affixed to said elastic 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.

3. The prosthetic heart valve according to claim 1 or 2 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 elastic frame and wherein said leaflets pass between said rigid ring and a lower edge of said elastic frame.

4. The prosthetic heart valve according to claim 3 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.

5. The prosthetic heart valve according to claim 4 wherein said annular elastic frame comprises a flexible ribbon.

6. The prosthetic heart valve according to claim 5 wherein said ribbon has a width greater than ten times a depth of said ribbon.

7. The prosthetic heart valve according to claim 1 or 2 wherein at least part of a border of each of said valve leaflets lies between said frame and said ring.

8. The prosthetic heart valve according to claim 7 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.

9. The prosthetic heart valve according to claim 8 wherein said annular elastic frame comprises a flexible ribbon having 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.

10. The prosthetic heart valve according to claim 9 wherein the annular ring further comprises a prominence adapted to conform to said second edge of said frame and proximal thereto.

11. The prosthetic heart valve according to claim 10 further comprising means for connecting said first edge of said frame to a distal edge of said rigid ring.

12. The prosthetic heart valve according to claim 11 wherein said valve leaflets further comprise a free edge connecting two adjacent commissures, said free edge being convex with respect to a line connecting a first junction between said free edge and one of said adjacent commissures and a second junction between said free edge and the other of said adjacent commissures.

13. The prosthetic heart valve according to claim 12 wherein said valve leaflets further comprise a fillet at each junction between said free edge and a commissure.

14. The prosthetic heart valve according to claim 13 wherein each of said commissures further comprise two adjacent interior edges, said edges being spaced a predetermined distance apart at a location adjacent said distal end and tapering towards each other away from said distal end to a second smaller distance and wherein a portion of the boarder of two adjacent leaflets are engaged between said adjacent interior edges.

19. The prosthetic heart valve according to claim 1 wherein each of said valve leaflets further comprises a first fillet at said junction between said free edge and said one of said adjacent commissures and a second fillet at said junction between said free edge and the other of said adjacent commissures.

15. A prosthetic heart valve comprising

a generally annular frame having a plurality of commissures extending generally axially and distally thereof;

a generally annular rigid base proximal of said frame and adjoining at least part of said frame, said frame comprising a distal edge, a proximal edge, and an outer side adjacent said base;

valve leaflets attached to said frame, each valve leaflet connecting adjacent commissures and each leaflet having a border;

at least part of said border of each of said valve leaflets lying between said frame and said base and attached to said frame near said distal edge of said frame and said border of said leaflets passing between said outer side of said frame and said base to said proximal edge of said frame and passing under a proximal edge of said frame, and

means for connecting said distal edge of said frame to a distal edge of said rigid base.

16. The prosthetic heart valve according to claim 15 wherein said annular base further comprises a channel adapted to conform to said outer side of said frame.

17. The prosthetic heart valve according to claim 16 wherein the annular base further comprises a prominence adapted to conform to said proximal edge of said frame and proximal thereto.

18. A prosthetic heart valve comprising

a generally annular frame having a plurality of commissures joined thereto and extending generally axially therefrom;

and

valve leaflets attached to said frame and connecting adjacent commissures, each of said valve leaflets further comprising a free edge connecting two adjacent commissures, each of said free edges 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.

20. A prosthetic heart valve comprising a frame having a plurality of commissures extending generally axially, each commissure terminating at a distal end and comprising two adjacent interior edges, said edges being spaced a predetermined distance apart at a location adjacent said distal end and tapering towards each other away from said distal end to a second smaller distance and

a plurality of leaflets, each leaflet connecting first and second adjacent commissures and having a border, a first portion of which is disposed between said edges of said first adjacent commissure and a second portion of which is disposed between said edges of said second adjacent commissure.