Leaflet attachment frame for a prosthetic valve

• US 10,413,406 B2
• Filed: 11/27/2018
• Issued: 09/17/2019
• Est. Priority Date: 12/14/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel
• Primary Examiner(s): Wolf, Megan Y
• Application Number:
  US16/201,625
• Publication Number:
  US 20190142583A1
• Time in Patent Office: 294 Days
• Field of Search: None
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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

Abstract

An implantable prosthetic valve has an upper frame section and a lower frame section. The upper frame section has a plurality of struts and a first leaflet receiving surface at a lower portion of the upper frame section. The lower frame section has a second leaflet receiving surface at an upper portion of the lower frame section. An edge of a flexible leaflet is disposed between the first and second leaflet receiving surfaces to attach the leaflet to the upper and lower frame sections.

Claims

1. An assembly comprising:

a balloon catheter comprising an inflatable balloon; and

an implantable prosthetic valve, comprising;

a radially collapsible and expandable annular frame comprising a plurality of struts and having an upper end and a lower end, wherein the struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells defining the upper end of the frame and a lowermost row of closed cells defining the lower end;

a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing leaflet side portions, each of the leaflet side portions being paired with an adjacent leaflet side portion of an adjacent leaflet to form commissures of the leaflet structure;

wherein the frame comprises a pair of vertical posts adjacent each of the commissures, the vertical posts of each pair being parallel to each other and spaced apart from each other so as to define an opening therebetween, wherein the vertical posts of each pair are connected to each other at their upper ends, wherein the pairs of vertical posts have respective lower ends that are axially spaced from the lower end of the frame;

wherein the pairs of vertical posts are positioned axially along the frame entirely within the uppermost row of closed cells and the pairs of vertical posts are circumferentially spaced apart from each other by a plurality of cells of the uppermost row of closed cells;

wherein each pair of leaflet side portions extends radially outwardly through the opening of a respective pair of vertical posts and are secured to the posts outside of the frame; and

wherein the prosthetic valve can be crimped around the balloon for delivery into a patient'"'"'s body and radially expanded at a treatment site within the patient'"'"'s body by inflating the balloon.

2. The assembly of claim 1, wherein the uppermost row of closed cells is formed partly by an uppermost, circumferentially extending row of angled struts of the frame interconnecting adjacent pairs of vertical posts.

3. The assembly of claim 2, wherein the angled struts of the uppermost row of angled struts are connected to each other at their upper ends by U-shaped connection portions, wherein each U-shaped connection portion comprises two vertical portions and a lateral portion extending between the two vertical portions, wherein the vertical portions are parallel to a central longitudinal axis of the prosthetic valve, wherein the lateral portion extends between and interconnects upper ends of the vertical portions, and wherein the vertical portions are spaced apart from each other to define a gap between the upper ends of a corresponding pair of adjacent struts.

4. The assembly of claim 1, wherein for each pair of the leaflet side portions and corresponding pair of vertical posts, one of the leaflet side portions wraps around at least a portion of one of the vertical posts at a location outside of the frame and the other leaflet side portion wraps around at least a portion of the other vertical post at a location outside of the frame.

5. The assembly of claim 4, wherein each commissure comprises a fabric member positioned radially outward of the frame at each pair of vertical posts and radially outward of the leaflet side portions that are wrapped around the vertical posts, the fabric member also being sutured to the leaflet side portions that are wrapped around the vertical posts.

6. The assembly of claim 1, wherein the plurality of circumferentially extending rows of closed cells includes an additional row of closed cells that is positioned axially below the uppermost row of closed cells and above the lowermost row of closed cells.

7. The assembly of claim 1, wherein each leaflet has a scalloped shaped lower edge portion secured to the frame.

8. The assembly of claim 1, wherein the cells of the uppermost row of closed cells are hexagonal.

9. An assembly comprising:

a balloon catheter comprising an inflatable balloon; and

an implantable prosthetic valve, comprising;

a radially collapsible and expandable annular frame comprising a plurality of struts and having an upper end and a lower end, wherein the struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells defining the upper end of the frame and a lowermost row of closed cells defining the lower end;

a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing leaflet side portions, each of the leaflet side portions being paired with an adjacent leaflet side portion of an adjacent leaflet to form commissures of the leaflet structure;

wherein the frame comprises a pair of vertical posts adjacent each of the commissures, the vertical posts of each pair being parallel to each other and spaced apart from each other so as to define an opening therebetween, wherein the vertical posts of each pair are connected to each other at their upper ends, wherein the pairs of vertical posts have respective lower ends that are axially spaced from the lower end of the frame;

wherein the pairs of vertical posts are positioned axially along the frame entirely within the uppermost row of closed cells and the pairs of vertical posts are circumferentially spaced apart from each other by a plurality of cells of the uppermost row of closed cells;

wherein the uppermost row of closed cells is formed partly by an uppermost, circumferentially extending row of angled struts of the frame interconnecting adjacent pairs of vertical posts and another circumferentially extending row of angled struts that are connected to the lower ends of the vertical posts;

wherein each pair of leaflet side portions extends radially outwardly through the opening of a respective pair of vertical posts and are secured to the posts outside of the frame; and

wherein the prosthetic valve can be crimped around the balloon for delivery into a patient'"'"'s body and radially expanded at a treatment site within the patient'"'"'s body by inflating the balloon.

10. The assembly of claim 9, wherein the leaflets have scalloped shaped lower edge portions that are sutured to fabric members that are sutured to the frame.

11. The assembly of claim 9, wherein the angled struts of the uppermost row of angled struts are connected to each other at their upper ends by U-shaped connection portions, wherein each U-shaped connection portion comprises two vertical portions and a lateral portion extending between the two vertical portions, wherein the vertical portions are parallel to a central longitudinal axis of the prosthetic valve, wherein the lateral portion extends between and interconnects upper ends of the vertical portions, and wherein the vertical portions are spaced apart from each other to define a gap between the upper ends of a corresponding pair of adjacent struts.

12. The assembly of claim 9, wherein for each pair of leaflet side portions and corresponding pair of vertical posts, one of the leaflet side portions wraps around at least a portion of one of the vertical posts at a location outside of the frame and the other leaflet side portion wraps around at least a portion of the other vertical post at a location outside of the frame.

13. The assembly of claim 12, wherein each commissure comprises a fabric member positioned radially outward of the frame at each pair of vertical posts and radially outward of the leaflet side portions that are wrapped around the vertical posts, the fabric member also being sutured to the leaflet side portions that are wrapped around the vertical posts.

14. The assembly of claim 9, wherein the plurality of circumferentially extending rows of closed cells includes an additional row of closed cells that is positioned axially below the uppermost row of closed cells and above the lowermost row of closed cells.

15. The assembly of claim 9, wherein the cells of the uppermost row of closed cells are hexagonal cells.

16. The assembly of claim 15, wherein the hexagonal cells have a length measured in an axial direction of the frame and a width measured in a circumferential direction of the frame, wherein the length is greater than the width.

17. An assembly comprising:

a balloon catheter comprising an inflatable balloon; and

an implantable prosthetic valve, comprising;

a radially collapsible and expandable annular frame comprising a plurality of struts and having an upper end and a lower end, wherein the struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells defining the upper end of the frame and a lowermost row of closed cells defining the lower end, wherein the frame comprises a material selected from the group comprising stainless steel, titanium, and a cobalt-chromium alloy;

a leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing leaflet side portions, each of the leaflet side portions being paired with an adjacent leaflet side portion of an adjacent leaflet to form commissures of the leaflet structure;

wherein the frame comprises a pair of vertical posts adjacent each of the commissures, the vertical posts of each pair being parallel to each other and spaced apart from each other so as to define an opening therebetween, wherein the vertical posts of each pair are connected to each other at their upper ends, wherein the pairs of vertical posts have respective lower ends that are axially spaced from the lower end of the frame;

wherein the pairs of vertical posts are positioned axially along the frame entirely within the uppermost row of closed cells and the pairs of vertical posts are circumferentially spaced apart from each other by a plurality of cells of the uppermost row of closed cells;

wherein the uppermost row of closed cells is formed partly by an uppermost, circumferentially extending row of angled struts of the frame interconnecting adjacent pairs of vertical posts and another circumferentially extending row of angled struts that are connected to the lower ends of the vertical posts;

wherein each pair of leaflet side portions extends radially outwardly through the opening of a respective pair of vertical posts and are secured to the posts outside of the frame;

wherein the leaflets have scalloped shaped lower edge portions that are sutured to fabric portions that are sutured to the frame;

wherein the opening of each pair of vertical posts has a constant width;

wherein the cells of the uppermost row of closed cells are hexagonal cells having a length measured in an axial direction of the frame and a width measured in a circumferential direction of the frame, wherein the length is greater than the width; and

wherein the prosthetic valve can be crimped around the balloon for delivery into a patient'"'"'s body and radially expanded at a treatment site within the patient'"'"'s body by inflating the balloon.