Prosthetic heart valve with paravalvular leak mitigation features

• US 10,456,249 B2
• Filed: 09/13/2017
• Issued: 10/29/2019
• Est. Priority Date: 09/15/2016
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Kaleta, Richard, High, Keith
• Primary Examiner(s): Pellegrino, Brian E
• Assistant Examiner(s): Zimmerman, Rebecca Lynee
• Application Number:
  US15/702,941
• Publication Number:
  US 20180071089A1
• Time in Patent Office: 776 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, and

wherein each of the selected cell struts has end portions and a center portion between the end portions, and when the stent is in the expanded condition, a radial distance between the ablumenal surface of the center portion and the second cuff is greater than a radial distance between the ablumenal surface of each end portion and the second cuff,

wherein a lumenal surface of the selected cell struts is straight in the length direction of the selected cell struts when the stent is in the expanded condition.

2. The prosthetic heart valve of claim 1, wherein the end portions and the center portion of the selected struts each have 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.

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

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