Leaflet attachment frame for a prosthetic valve

• US 10,413,404 B2
• Filed: 12/01/2016
• 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): Sweet, Thomas
• Assistant Examiner(s): Wolf, Megan Y
• Application Number:
  US15/367,092
• Publication Number:
  US 20170079788A1
• Time in Patent Office: 1,020 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 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 leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing leaflet side portions, each leaflet side portion 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, and 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 closed 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, 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, and wherein each U-shaped connection portion forms a gap between adjacent upper ends of a corresponding pair of angled struts;

wherein each pair of leaflet side portions extends radially outwardly through the opening of a respective pair of vertical posts, with one of the leaflet side portions wrapping around at least a portion of one of the vertical posts at a location outside of the frame and the other leaflet side portion wrapping around at least a portion of the other vertical post at a location outside of the frame; and

wherein each commissure comprises a cloth portion 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 cloth portion also being sutured to the leaflet side portions that are wrapped around the vertical posts.

2. The implantable prosthetic valve of claim 1, wherein each leaflet has a scalloped shaped lower edge portion secured to the frame.

3. The implantable prosthetic valve of claim 2, further comprising additional cloth portions sutured to opposite surfaces of the lower edge portion of each leaflet.

4. The implantable prosthetic valve of claim 1, wherein the cloth portion of each commissure comprises a first cloth portion and each commissure further comprises second and third cloth portions, the second cloth portion wrapping around at least a portion of one of the vertical posts and the third cloth portion wrapping around at least a portion of the other vertical post, each of the second and third cloth portions being sutured to the first cloth portion and one of the leaflet side portions that is wrapped around one of the vertical posts.

5. The implantable prosthetic valve of claim 4, wherein each of the second and third cloth portions of each commissure is wrapped completely around a respective vertical post and is sutured to itself as well as an adjacent leaflet side portion that is wrapped around the same vertical post.

6. The implantable prosthetic valve of claim 1, wherein:

the frame comprises an upper frame section and a lower frame section, the upper frame section having a plurality of struts and a first leaflet receiving surface at a lower portion of the upper frame section, the lower frame section having a second leaflet receiving surface at an upper portion of the lower frame section; and

each leaflet comprises a lower edge portion disposed between the first and second leaflet receiving surfaces.

7. The implantable prosthetic valve of claim 6, wherein the first and second leaflet receiving surfaces are scalloped shaped.

8. The implantable prosthetic valve of claim 1, wherein the leaflets have scalloped shaped lower edge portions secured to the frame, and wherein the implantable prosthetic valve further comprises additional cloth portions wrapped around the lower edge portions of the leaflets.

9. The implantable prosthetic valve of claim 1, wherein each U-shaped connection portion comprises two vertical surfaces and a lateral surface extending between the two vertical surfaces, wherein the vertical surfaces are parallel to a central longitudinal axis of the prosthetic valve, wherein the lateral surface extends between and interconnects upper ends of the vertical surfaces, and wherein the vertical surfaces are spaced apart from each other to define the gap of the U-shaped connection portion.

10. The implantable prosthetic valve of claim 1, wherein:

the frame comprises an upper frame section and a lower frame section, the upper frame section having a plurality of struts and a scallop-shaped lower edge, the lower frame section having a scallop-shaped upper edge;

wherein the lower edge of the upper frame section and the upper edge of the lower frame section are spaced apart to define a leaflet-receiving opening;

wherein the leaflet-receiving opening extends continuously between adjacent pairs of vertical posts; and

each leaflet comprises a lower edge portion disposed within the leaflet-receiving opening.

11. A method of assembling an implantable prosthetic valve comprising:

providing 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, the frame comprising a plurality of circumferentially spaced pairs of vertical posts, 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 closed 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, wherein the angled struts of the uppermost, circumferentially extending row of angled struts are connected to each other at their upper ends by U-shaped connection portions, wherein each U-shaped connection portion forms a gap between adjacent upper ends of a corresponding pair of angled struts;

providing a leaflet structure comprising a plurality of leaflets each comprising two opposing leaflet side portions;

inserting a pair of adjacent leaflet side portions through the opening of each pair of vertical posts in a radially outward direction;

wrapping one leaflet side portion of each pair of adjacent leaflet side portions at least partially around one of the vertical posts and wrapping the other leaflet side portion of each pair of adjacent leaflet side portions at least partially around the other vertical post; and

suturing a cloth portion to each pair of adjacent leaflet side portions at a location outside of the frame and radially outward of the adjacent leaflet side portions that are wrapped around the vertical posts.

12. The method of claim 11, further comprising suturing additional cloth portions to opposite surfaces of a scalloped shaped lower edge portion of each leaflet.

13. The method of claim 12, further comprising securing the lower edge portion of each leaflet to the frame after suturing the additional cloth portions to the leaflets.

14. The method of claim 11, further comprising securing two additional cloth portions to each pair of adjacent leaflet side portions by wrapping the additional cloth portions at least partially around respective vertical posts and suturing them to the adjacent leaflet side portions.

15. The method of claim 14, wherein each additional cloth portion is wrapped completely around a respective vertical post and is sutured to itself as well as an adjacent leaflet side portion of a leaflet that is wrapped around the same vertical post.

16. 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 leaflet structure positioned within the frame, the leaflet structure comprising a plurality of leaflets each comprising two opposing leaflet side portions, each leaflet side portion 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 closed 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, wherein the angled struts of the uppermost, circumferentially extending 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 angled struts; and

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 vertical posts outside of the frame.

17. The implantable prosthetic valve of claim 16, 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.

18. The implantable prosthetic valve of claim 17, wherein each commissure comprises a cloth portion 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 cloth portion also being sutured to the leaflet side portions that are wrapped around the vertical posts.

19. The implantable prosthetic valve of claim 16, wherein the plurality of circumferentially extending rows of closed cells includes additional rows of closed cells that are positioned axially below the uppermost row of closed cells and the pairs of vertical posts.