Reduced profile prosthetic heart valve

• US 9,700,409 B2
• Filed: 11/05/2014
• Issued: 07/11/2017
• Est. Priority Date: 11/06/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Smith, Kent J.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US14/533,408
• Publication Number:
  US 20150127100A1
• Time in Patent Office: 979 Days
• 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
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/0062 Kits of prosthetic parts to be assembled in various combinations for forming different prostheses

Abstract

A prosthetic heart valve may include a stent body with a plurality of cells arranged in circumferential rows and a cuff attached to the stent. A leaflet attachment panel may be attached to and span a portion of one of the cells. A prosthetic valve element, such as a leaflet having a belly, may be mounted to the leaflet attachment panel. The leaflet attachment panel may not be integral with the stent body. A reduced overlap area may be defined between a proximal end of the stent body and a proximalmost point of attachment of the leaflet belly to the cuff. The reduced overlap area may have a size dependent upon the circumferential row of cells the leaflet attachment panel is attached to and a position of the portion of the leaflet attachment panel to which the leaflet is mounted. Alternately, the leaflet may be attached directly to the stent.

Claims

1. A prosthetic heart valve, comprising:

a stent body including a plurality of cells arranged in circumferential rows, the plurality of cells including a first group of cells and a second group of cells, the stent body extending from an inflow end to an outflow end in a longitudinal direction;

a cuff sutured to the stent body;

at least one leaflet attachment panel sutured to the stent so that each cell in the first group of cells is at least partially covered by the at least one leaflet attachment panel and each cell in the second group of cells is fully uncovered by the at least one leaflet attachment panel, the at least one leaflet attachment panel being discontinuous with an adjacent leaflet attachment panel; and

at least one prosthetic valve element sutured to a single layer of the at least one leaflet attachment panel;

wherein the leaflet attachment panel is integral with none of the stent body, the cuff, and the prosthetic valve element;

wherein the cuff covers at least part of a luminal or abluminal surface of the stent body and a portion of the cuff is aligned with the at least one leaflet attachment panel in a radial direction transverse the longitudinal direction.

2. The prosthetic heart valve of claim 1, wherein the prosthetic valve element comprises a leaflet.

3. The prosthetic heart valve of claim 1, wherein the leaflet attachment panel is at least partially formed of fabric.

4. The prosthetic heart valve of claim 1, wherein the leaflet attachment panel is at least partially formed of tissue.

5. The prosthetic heart valve of claim 1, wherein the leaflet attachment panel spans an entire area of only one cell.

6. The prosthetic heart valve of claim 5, wherein the leaflet attachment panel spans more than the area of one entire cell.

7. The prosthetic heart valve of claim 1, wherein the leaflet attachment panel spans less than an area of one entire cell, the leaflet attachment panel having a free edge.

8. The prosthetic heart valve of claim 7, wherein the leaflet attachment panel spans approximately three-fourths the area of one entire cell.

9. The prosthetic heart valve of claim 7, wherein the leaflet attachment panel spans approximately half the area of one entire cell.

10. The prosthetic heart valve of claim 7, wherein the leaflet attachment panel spans approximately one-fourth the area of one entire cell.

11. The prosthetic heart valve of claim 7, wherein the free edge forms a substantially straight line.

12. The prosthetic heart valve of claim 7, wherein the free edge is curved.

13. The prosthetic heart valve of claim 1, wherein the stent body includes an annulus section defining a first circumferential row of cells, an aortic section defining a second circumferential row of cells, and a third circumferential row of cells positioned between the first and second rows of cells.

14. The prosthetic heart valve of claim 13, wherein the cell to which the leaflet attachment panel is attached is in the second circumferential row of cells.

15. The prosthetic heart valve of claim 13, wherein the cell to which the leaflet attachment panel is attached is in the third circumferential row of cells.

20. The prosthetic heart valve of claim 1, wherein the cuff is formed of a biological material.

21. The prosthetic heart valve of claim 1, wherein the cuff is formed of a polymer.

16. A prosthetic heart valve, comprising:

a stent body extending in a longitudinal direction from an inflow end at a proximal end of the stent body to an outflow end at a distal end of the stent body, and including a plurality of cells arranged in a plurality of circumferential rows;

a cuff sutured to the stent body and covering at least part of a luminal or abluminal surface of the stent body;

a leaflet attachment panel sutured to at least one cell in one of the circumferential rows and spanning an entire area of only one cell;

a leaflet sutured to a single layer of the leaflet attachment panel, the leaflet including a leaflet belly having a proximalmost point of attachment to the cuff;

a reduced overlap area defined between the proximal end of the stent body and the proximalmost point of attachment of the leaflet belly to the cuff, the reduced overlap area having a size;

wherein the size of the reduced overlap area is dependent upon (i) the circumferential row of cells the leaflet attachment panel is attached to and (ii) a position of the portion of the leaflet attachment panel to which the leaflet is mounted;

wherein the leaflet attachment panel is integral with none of the stent body, the cuff and the leaflet, and a portion of the cuff is aligned with the leaflet attachment panel in a radial direction transverse the longitudinal direction.

17. The prosthetic heart valve of claim 16, wherein, when the leaflet is attached to a given portion of the leaflet attachment panel, the size of the reduced overlap area is greater when the leaflet attachment panel is attached to a relatively distal circumferential row of cells compared to when the leaflet attachment panel is attached to a relatively proximal circumferential row of cells.

18. The prosthetic heart valve of claim 16, wherein, when the leaflet attachment panel is attached to a given circumferential row of cells, the size of the reduced overlap area is greater when the leaflet is attached to a relatively distal portion of the leaflet attachment panel compared to when the leaflet is attached to a relatively proximal portion of the leaflet attachment panel.

19. A prosthetic heart valve, comprising:

a stent body extending in a longitudinal direction from an inflow end at a proximal end of the stent body to an outflow end at a distal end of the stent body, the stent body being formed from a plurality of open cells arranged in circumferential rows;

a cuff sutured to the stent body and covering at least part of a luminal or abluminal surface of the stent body;

a leaflet attachment panel sutured to and overlying at least a portion of one of the open cells and spanning an entire area of only one cell, the leaflet attachment panel having a proximal end and a distal end; and

a leaflet sutured to a single layer of the leaflet attachment panel between the proximal end and the distal end thereof, the leaflet including a leaflet belly having a proximalmost point of attachment to the cuff,

wherein an area between the proximal end of the stent body and the proximalmost point of attachment of the leaflet belly to the cuff defines a reduced overlap area having a longitudinal length;

wherein the longitudinal length of the reduced overlap area is dependent at least upon a location of attachment of the leaflet to the leaflet attachment panel between the proximal end and distal end thereof; and

wherein the leaflet attachment panel is integral with none of the stent body, the cuff and the leaflet, and a portion of the cuff is aligned with the leaflet attachment panel in a radial direction transverse the longitudinal direction.