Stent designs for prosthetic heart valves

• US 10,117,742 B2
• Filed: 09/08/2014
• Issued: 11/06/2018
• Est. Priority Date: 09/12/2013
• 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.
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US14/479,947
• Publication Number:
  US 20150073545A1
• Time in Patent Office: 1,520 Days
• 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 2210/0061 swellable
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a collapsible and expandable stent, a cuff attached to an annulus section of the stent, and leaflets attached to the cuff between a first location and a second location distal to the first location in a flow direction. The stent may include struts shaped to form a plurality of cells connected to one another in annular rows around the stent. The cuff may have top and bottom edges and may occupy a first group of the cells, such that cells above the top edge are open cells at least partially devoid of the cuff. The cuff may have a landing zone extending at least one-third of a length of the stent in the flow direction between the bottom edge of the cuff and a proximal end of a most proximal cell of the open cells when the stent is in an expanded use condition.

Claims

1. A prosthetic heart valve configured to be expanded between native leaflets of a native aortic annulus of a patient, the prosthetic heart valve comprising:

a stent having a proximal end at a proximalmost edge of the stent, a distal end at a distalmost edge of the stent, an annulus section adjacent the proximal end, and an aortic section adjacent the distal end, the stent being movable between a collapsed condition and an expanded use condition, the stent including a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent, the stent defining a flow direction from the proximal end toward the distal end, the stent having a minimum diameter in a direction perpendicular to the flow direction and a length in the flow direction, the length of the stent defined between the proximal and the distal ends when the stent is in the expanded use condition, the length of the stent being greater than the minimum diameter;

a cuff attached to the annulus section of the stent, the cuff having distal and proximal edges and occupying a first group of the plurality of cells, such that some of the plurality of cells distal to the distal edge are open cells at least partially devoid of the cuff, the cuff having a landing zone that is a continuous cylindrical portion of the cuff, the landing zone having a length parallel to the flow direction extending at least one-third of the length of the stent in the flow direction, the length of the landing zone defined between the proximal edge of the cuff and a proximalmost location along the distal edge of the cuff; and

a plurality of prosthetic valve leaflets attached to the cuff between a first location and a second location distal to the first location in the flow direction, each of the plurality of prosthetic valve leaflets having a free edge, the plurality of prosthetic valve leaflets being attached to the cuff while the stent is in the collapsed condition and in the expanded use condition,

wherein the entire free edge of each of the plurality of prosthetic valve leaflets is located within a first distance in the flow direction from the distal end of the stent when the plurality of prosthetic valve leaflets are in an open position and the stent is in the expanded use condition, the first distance being less than the length of the landing zone in the flow direction.

2. The prosthetic heart valve of claim 1, wherein the landing zone extends at least 16 mm in the flow direction between the proximal edge of the cuff and a proximal end of a most proximal cell of the open cells when the stent is in the expanded use condition.

3. The prosthetic heart valve of claim 1, wherein the cuff includes a proximal portion and a distal portion, the proximal portion being coupled to a first group of the plurality of struts adjacent the proximal edge and having a first average thickness in a radial direction perpendicular to the flow direction, the distal portion being coupled to a second group of the plurality of struts adjacent the distal edge and having a second average thickness in the radial direction, the first average thickness being greater than the second average thickness.

4. The prosthetic heart valve of claim 3, wherein approximately all of the proximal portion of the cuff is located between the first location and the proximal end of the stent.

5. The prosthetic heart valve of claim 3, wherein the cuff is disposed on a luminal surface of the stent.

6. The prosthetic heart valve of claim 3, wherein the distal portion of the cuff includes a plurality of pockets containing a material that is configured to swell in size when contacted by blood.

7. The prosthetic heart valve of claim 3, wherein the proximal portion of the cuff occupies every cell in a first row of the plurality of annular rows of cells, the distal portion of the cuff occupies every cell in a second row of the annular rows of cells adjacent the first row, and the distal portion of the cuff also occupies a subset of cells in a third row of the annular rows of cells adjacent the second row such that at least some of the open cells are located in the third row.

8. The prosthetic heart valve of claim 3, wherein the proximal portion of the cuff is initially separate from the distal portion of the cuff and is sutured to a proximal edge of the distal portion of the cuff at a distal edge of the proximal portion of the cuff.

9. The prosthetic heart valve of claim 8, wherein the proximal portion of the cuff and the distal portion of the cuff are made of different materials.

10. The prosthetic heart valve of claim 8, wherein the proximal portion of the cuff and the distal portion of the cuff are sutured to one another along a boundary line that extends between adjacent rows of the plurality of annular rows of cells.

11. The prosthetic heart valve of claim 8, wherein the proximal portion of the cuff and the distal portion of the cuff are sutured to one another along a boundary line that extends in a substantially circular closed curve about a circumference of the stent, the curve lying in a plane generally perpendicular to the flow direction.

12. A prosthetic heart valve configured to be expanded between native leaflets of a native aortic annulus of a patient, the prosthetic heart valve comprising:

a stent having a proximal end at a proximalmost edge of the stent, a distal end at a distalmost edge of the stent, an annulus section adjacent the proximal end, and an aortic section adjacent the distal end, the stent being movable between a collapsed condition and an expanded use condition, the stent including a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent, the stent defining a flow direction from the proximal end toward the distal end, the stent having a minimum diameter in a direction perpendicular to the flow direction and a length in the flow direction, the length of the stent defined between the proximal and the distal ends when the stent is in the expanded use condition, the length of the stent being greater than the minimum diameter;

a cuff attached to the stent; and

a plurality of prosthetic valve leaflets attached to the cuff between a first location and a second location distal to the first location in the flow direction, each of the plurality of prosthetic valve leaflets having a free edge, the plurality of prosthetic valve leaflets being attached to the cuff while the stent is in the collapsed condition and in the expanded use condition, the entire free edge of each of the plurality of prosthetic valve leaflets being distal to a location along the stent length located at a position that is a distance of at least three-fifths of the length of the stent, and the distance extends from the proximalmost edge.

13. The prosthetic heart valve of claim 12, wherein the entire free edge of each of the plurality of prosthetic valve leaflets is located at least about 25 mm distal to the proximal end of the stent when the plurality of prosthetic valve leaflets are in the open position and the stent is in the expanded use condition.

14. The prosthetic heart valve of claim 12, wherein the entire free edge of each of the plurality of prosthetic valve leaflets is located between about 25 mm and about 40 mm distal to the proximal end of the stent when the plurality of prosthetic valve leaflets are in the open position and the stent is in the expanded use condition.

15. The prosthetic heart valve of claim 12, wherein the length of the stent between the distal end and the proximal end in the flow direction is no more than 50 mm in the expanded use condition.

16. The prosthetic heart valve of claim 12, wherein the length of the stent between the distal end and the proximal end in the flow direction is between about 30 mm and about 50 mm in the expanded use condition.

17. The prosthetic heart valve of claim 12, wherein the aortic section has an expanded diameter greater than an expanded diameter of the annulus section, the annulus section of the stent includes three of the annular rows of cells and the aortic section of the stent includes one of the annular rows of cells, and the rows of cells in the annulus section together have a greater combined length in the flow direction than the row of cells in the aortic section when the stent is in the expanded use condition.

18. The prosthetic heart valve of claim 12, wherein when the prosthetic heart valve is expanded between the native leaflets of the native aortic annulus such that the proximal end of the stent is located proximal to a proximal end of the native aortic annulus, and the plurality of prosthetic valve leaflets are in the open position, the entire free edge of each of the plurality of prosthetic valve leaflets is located distal to a free edge of each of the native leaflets.

19. The prosthetic heart valve of claim 12, wherein when the prosthetic heart valve is expanded between the native leaflets of the native aortic annulus such that the proximal end of the stent is located proximal to a proximal end of the native aortic annulus, and the plurality of prosthetic valve leaflets are in the open position, the entire free edge of each of the plurality of prosthetic valve leaflets is located at least 10 mm distal to a free edge of each of the native leaflets.

20. The prosthetic heart valve of claim 12, wherein when the prosthetic heart valve is expanded between the native leaflets of the native aortic annulus such that the proximal end of the stent is located proximal to a proximal end of the native aortic annulus, and the plurality of prosthetic valve leaflets are in the open position, the entire free edge of each of the plurality of prosthetic valve leaflets is located between about 10 mm and about 20 mm distal to a free edge of each of the native leaflets.

21. The prosthetic heart valve of claim 12, wherein the cuff has distal and proximal edges and occupies a first group of the plurality of cells, such that some of the plurality of cells distal to the distal edge are open cells at least partially devoid of the cuff, and when the prosthetic heart valve is expanded between the native leaflets of the native aortic annulus such that the proximal end of the stent is located proximal to a proximal end of the native aortic annulus, at least a portion of each of the open cells is located distal to a free edge of each of the native leaflets.

22. The prosthetic heart valve of claim 21, wherein when the prosthetic heart valve is expanded between the native leaflets of the native aortic annulus such that the proximal end of the stent is located proximal to a proximal end of the native aortic annulus, each of the open cells is located entirely distal to the free edge of each of the native leaflets.

23. The prosthetic heart valve of claim 12, wherein the aortic section of the stent includes struts that form a plurality of independent fingers, each of the fingers extending distally from a distal apex of a respective one of the plurality of cells to a free end, each of the fingers having a length of at least 8 mm, each of the free ends being spaced from the free ends of the other fingers.

24. The prosthetic heart valve of claim 23, wherein the aortic section of the stent includes a connecting element extending about a circumference of the prosthetic heart valve between the fingers, the connecting element including a porous material configured to permit tissue ingrowth.

25. A prosthetic heart valve configured to be expanded between native leaflets of a native aortic annulus of a patient, the prosthetic heart valve comprising:

a stent having a proximal end at a proximalmost edge of the stent, a distal end at a distalmost edge of the stent, an annulus section adjacent the proximal end, and an aortic section adjacent the distal end, the stent being collapsible and expandable, the stent including a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent, the stent defining a flow direction from the proximal end toward the distal end, the stent having a minimum diameter in a direction perpendicular to the flow direction and a length in the flow direction, the length of the stent defined between the proximal and the distal ends when the stent is in an expanded use condition, the length of the stent being greater than the minimum diameter;

a cuff attached to the annulus section of the stent, the cuff having distal and proximal edges and occupying a first group of the plurality of cells, such that some of the plurality of cells distal to the distal edge are open cells at least partially devoid of the cuff, the cuff having a landing zone that is a continuous cylindrical portion of the cuff, the landing zone having a length parallel to the flow direction extending at least one-third of the length of the stent in the flow direction, the length of the landing zone defined between the proximal edge of the cuff and a proximalmost location along the distal edge of the cuff; and

a plurality of prosthetic valve leaflets sutured to the cuff between a first location and a second location distal to the first location in the flow direction, each of the plurality of prosthetic valve leaflets having a free edge,

wherein the entire free edge of each of the plurality of prosthetic valve leaflets is located within a first distance in the flow direction from the distal end of the stent when the plurality of prosthetic valve leaflets are in an open position and the stent is in the expanded use condition, the first distance being less than the length of the landing zone in the flow direction.