PROSTHETIC HEART VALVE WITH PARAVALVULAR LEAK MITIGATION FEATURES

• US 20180071089A1
• Filed: 09/13/2017
• Published: 03/15/2018
• Est. Priority Date: 09/15/2016
• 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: Kaleta, Richard, High, Keith
• Granted Patent: US 10,456,249 B2
• Time in Patent Office: 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 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a collapsible and expandable stent with a valve assembly disposed therein. A first cuff is positioned on the lumenal or ablumenal surface of the stent. A second cuff is positioned radially outward of the stent and the first cuff. The second cuff may include apertures that allow blood to pass through the second cuff into the spaces between the first and second cuffs. The second cuff may include a proximal edge with a plurality of notches that may be closed to create puckered areas in the second cuff to facilitate the movement of blood in the spaces between the first and second cuffs. The stent may include struts adjacent the second cuff that bow radially inwardly to create additional space for blood to flow in the spaces between the first and second cuffs.

Claims

1. A prosthetic heart valve for replacing a native valve, comprising:

a stent extending in an axial direction between an inflow end and an outflow end and having circumferential rows of cells formed by cell struts, the stent having a collapsed condition and an expanded condition;

a valve assembly disposed within the stent;

a first cuff disposed on a lumenal surface of the stent; and

a second cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about one of the circumferential rows of cells and positioned radially outward of the first cuff and the stent;

wherein an ablumenal surface of selected cell struts forming the one circumferential row of cells has a concave curvature in a length direction of the selected cell struts when the stent is in the expanded condition.

2. The prosthetic heart valve of claim 1, wherein each of the selected cell struts has end portions and a center portion between the end portions, with the stent in the expanded condition a radial distance between the ablumenal surface of the center portion and the second cuff being greater than a radial distance between the ablumenal surface of each end portion and the second cuff.

3. The prosthetic heart valve of claim 1, wherein a lumenal surface of the selected cell struts has a convex curvature in the length direction of the selected cell struts when the stent is in the expanded condition.

4. The prosthetic heart valve of claim 3, wherein each of the selected cell struts has a substantially constant strut thickness in a radial direction of the stent.

5. The prosthetic heart valve of claim 1, wherein a lumenal surface of the selected cell struts is substantially straight in the length direction of the selected cell struts when the stent is in the expanded condition.

6. The prosthetic heart valve of claim 1, wherein each of the selected cell struts has end portions and a center portion between the end portions, the end portions and the center portion each having a strut thickness in a radial direction of the stent, the strut thickness of the center portion being less than the strut thicknesses of the end portions.

7. The prosthetic heart valve of claim 1, wherein the concave curvature extends along an entire length of the selected cell struts.

8. The prosthetic heart valve of claim 1, wherein the concave curvature extends along less than an entire length of the selected cell struts.

9. A prosthetic heart valve for replacing a native valve, comprising:

a stent extending in an axial direction between an inflow end and an outflow end, the stent having a collapsed condition and an expanded condition;

a valve assembly disposed within the stent;

a first cuff disposed on a lumenal surface of the stent; and

a second cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent and positioned radially outward of the first cuff and the stent, the second cuff including a plurality of notches at spaced apart locations along the proximal edge, each of the notches defining a void in the proximal edge of the second cuff, the second cuff having an initial configuration in which the voids render the proximal edge of the second cuff discontinuous, and a gathered configuration in which the voids are closed so that the proximal edge of the second cuff is substantially continuous, the proximal edge of the second cuff in the gathered configuration having a length that is less than the length of the proximal edge of the second cuff in the initial configuration, the second cuff being coupled to at least one of the stent and the first cuff so that in the expanded condition of the stent, the second cuff is in the gathered configuration.

10. The prosthetic heart valve of claim 9, wherein with the proximal edge of the second cuff in the gathered configuration and the stent in the expanded condition, the second cuff includes a plurality of puckered portions, each of the puckered portions being aligned in the axial direction with one of the notches and extending farther radially outwardly from the stent than portions of the second cuff positioned circumferentially between adjacent ones of the notches.

11. The prosthetic heart valve of claim 10, further comprising a plurality of attachment points at which the second cuff is coupled to at least one of the stent and the first cuff, each of the puckered portions being positioned between a pair of adjacent attachment points in a circumferential direction of the stent.

12. The prosthetic heart valve of claim 11, wherein the stent includes a plurality of circumferential rows of cells, the second cuff being in radial alignment with a proximalmost one of the circumferential rows of cells.

13. The prosthetic heart valve of claim 12, wherein each of the puckered portions is positioned circumferentially between a pair of adjacent cells in the proximalmost row of cells.

14. The prosthetic heart valve of claim 9, wherein each of the notches has a triangular shape in the initial configuration of the second cuff.

15. The prosthetic heart valve of claim 9, wherein portions of the proximal edge of the second cuff adjacent each of the notches are coupled to one another in the gathered configuration of the second cuff.

16. A prosthetic heart valve for replacing a native valve, comprising:

a stent extending in an axial direction from an inflow end to an outflow end, the stent having a collapsed condition and an expanded condition;

a valve assembly disposed within the stent;

a first cuff annularly disposed on a lumenal or ablumenal surface of the stent; and

a second cuff having a proximal edge facing toward the inflow end of the stent and a distal edge facing toward the outflow end of the stent, the second cuff being annularly disposed about the stent and positioned radially outward of the first cuff and the stent, the second cuff including a plurality of apertures.

17. The prosthetic heart valve of claim 16, further comprising a plurality of attachment points at which the second cuff is attached to at least one of the stent and the first cuff, each aperture in the second cuff being aligned in the axial direction with a respective one of the plurality of attachment points.

18. The prosthetic heart valve of claim 16, wherein each of the apertures has a triangular shape.

19. The prosthetic heart valve of claim 18, wherein the triangular shape of each of the apertures includes a base oriented substantially parallel to the proximal edge of the second cuff and a vertex positioned closer to the distal edge of the second cuff than to the proximal edge of the second cuff.

20. The prosthetic heart valve of claim 16, wherein the stent includes a plurality of circumferential rows of cells, the second cuff being in radial alignment with a proximalmost one of the circumferential rows of cells, and each of the apertures in the second cuff is positioned circumferentially between a pair of adjacent cells in the proximalmost row of cells.