Stationary intra-annular halo designs for paravalvular leak (PVL) reduction—active channel filling cuff designs

• US 10,500,039 B2
• Filed: 09/20/2017
• Issued: 12/10/2019
• Est. Priority Date: 01/24/2014
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Braido, Peter N., Smith, Kent J., McCarthy, Andrea L., Fahim, Mina S.
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/710,007
• Publication Number:
  US 20180008402A1
• Time in Patent Office: 811 Days
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

Claims

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

a collapsible and expandable stent extending in a flow direction from a proximal end to a distal end, the stent including an annulus section adjacent the proximal end and a plurality of struts shaped to form a plurality of cells connected to one another in a plurality of annular rows around the stent;

a cuff attached to the annulus section of the stent and having an outer surface facing in radial directions orthogonal to the flow direction;

a plurality of prosthetic valve leaflets attached to the cuff; and

a plurality of sealing members in the annulus section of the stent, each sealing member having a first end, a second end, an open side facing toward the distal end of the stent and a closed side facing toward the proximal end of the stent so that blood flowing in a direction opposite the flow direction can enter at least one of the sealing members through the open side and cause an outer surface of the at least one sealing member to move away from the outer surface of the cuff, the sealing members including lower sealing members and upper sealing members, the upper sealing members being spaced a greater distance in the flow direction from the proximal end of the stent than the lower sealing members.

2. The prosthetic heart valve of claim 1, wherein the open sides of the lower sealing members are spaced a first distance from the proximal end of the stent in the flow direction, and the open sides of the upper sealing members are spaced a second distance from the proximal end of the stent in the flow direction, the second distance being greater than the first distance.

3. The prosthetic heart valve of claim 2, wherein the open sides of the lower sealing members are spaced apart about a circumference of the stent by first openings, the open sides of the upper sealing members are spaced apart about the circumference of the stent by second openings, the open sides of the upper sealing members are aligned in the flow direction with the first openings, and the open sides of the lower sealing members are aligned in the flow direction with the second openings, such that blood flow in a direction opposite the flow direction along the outer surface of the cuff will encounter at least one of the open sides of the upper or lower sealing members.

4. The prosthetic heart valve of claim 1, wherein each sealing member has a shape selected from the group consisting of triangular, crescent-shaped, rectangular, or square.

5. The prosthetic heart valve of claim 1, wherein each leaflet is attached to the cuff along a belly portion, the belly portion including an attachment point at which the leaflet is closest to the proximal end of the stent, each of the attachment points is at a predetermined distance from the proximal end of the stent, the attachment points collectively define a positioning line circumscribing a circumference of the stent at the predetermined distance from the proximal end of the stent, and each of the lower sealing members is located between the proximal end of the stent and the positioning line.

6. The prosthetic heart valve of claim 1, wherein each leaflet is attached to the cuff along a belly portion, the belly portion including an attachment point at which the leaflet is closest to the proximal end of the stent, each of the attachment points is at a predetermined distance from the proximal end of the stent, the attachment points collectively define a positioning line circumscribing a circumference of the stent at the predetermined distance from the proximal end of the stent, and each of the upper sealing members is located between the distal end of the stent and the positioning line.

7. The prosthetic heart valve of claim 1, wherein the stent includes commissure features each located at a juncture of adjacent ones of the leaflets, at least a portion of each leaflet being attached to one of the commissure features, and each of the lower sealing members is substantially aligned in the flow direction with a respective one of the commissure features.

8. The prosthetic heart valve of claim 1, wherein each leaflet is attached to the cuff along a belly portion, the belly portion including an attachment point at which the leaflet is closest to the proximal end of the stent, and each of the upper sealing members is substantially aligned in the flow direction with a respective one of the attachment points.

9. The prosthetic heart valve of claim 1, wherein the upper sealing members alternate with the lower sealing members around a circumference of the stent.

10. The prosthetic heart valve of claim 1, wherein the open side of each of the sealing members has a first length between the first and second ends, first and second end portions connected to the cuff and a center portion between the first and second end portions unconnected to the cuff, the center portion having a second length less than the first length.

11. The prosthetic heart valve of claim 1, wherein the open side of each of the sealing members has a first length between the first and second ends, a first portion connected to the cuff and a second portion unconnected to the cuff, the second portion having a second length less than the first length.

12. The prosthetic heart valve of claim 1, wherein each of the lower sealing members has a first width in a circumferential direction of the stent and each of the upper sealing members has a second width in the circumferential direction of the stent, the second width being equal to the first width.

13. The prosthetic heart valve of claim 1, wherein

the stent includes commissure features at a spaced distance from the proximal end of the stent, the commissure features collectively defining a positioning line circumscribing a circumference of the stent at the spaced distance from the proximal end of the stent, and

the cuff has a proximal edge and a distal edge, portions of the distal edge being positioned between the distal end of the stent and the positioning line.

14. The prosthetic heart valve of claim 13, wherein the distal edge of the cuff includes a zig-zag pattern of peaks pointing toward the proximal end of the stent alternating with peaks pointing toward the distal end of the stent, the peaks pointing toward the distal end of the stent including a first group of peaks each terminating at a position between the distal end of the stent and the positioning line and a second group of peaks each terminating at a position between the proximal end of the stent and the positioning line.