Prosthetic heart valve having improved commissure supports

• US 9,168,131 B2
• Filed: 12/07/2012
• Issued: 10/27/2015
• Est. Priority Date: 12/09/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yohanan, Ziv, Levi, Tamir S., Benichou, Netanel, Bukin, Michael, Gurovich, Nik, Sherman, Elena
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/708,598
• Publication Number:
  US 20130150956A1
• Time in Patent Office: 1,054 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A prosthetic heart valve according to the present disclosure comprises a radially collapsible and expandable annular frame and a leaflet structure comprising a plurality of leaflets mounted within the frame. The frame in particular embodiments can have commissure attachment portions that are configured to support the commissures of the leaflets at locations spaced radially inwardly toward the longitudinal flow axis of the prosthetic valve relative to the frame portions circumscribing the moveable portions of the leaflets. When the leaflets open under pressure of blood flowing through the prosthetic valve, the moveable portions of the leaflets are retained at positions spaced inwardly from the inner surface of the frame to protect against abrasion of the leaflets.

Claims

1. A prosthetic valve comprising:

a radially collapsible and expandable annular frame having an inlet end and an outlet end, the frame having a three angularly spaced commissure attachment portions and three lobed portions extending between the commissure attachment portions, each of the lobed portions extending farther radially outwardly than the commissure attachment portions, the three lobed portions defining a tri-lobed cross-sectional shape for providing three artificial sinuses; and

a leaflet structure comprising three leaflets, each leaflet comprising opposing side portions and an upper edge extending between the side portions, wherein each side portion is secured to an adjacent side portion of another leaflet to form commissures of the leaflet structure, each commissure being attached to one of the commissure attachment portions of the frame, the leaflets being movable between an open position to allow blood to flow through the prosthetic valve from the inlet end to the outlet end and a closed position to inhibit the flow of blood through the prosthetic valve from the outlet end to the inlet end, wherein a clearance is maintained between the upper edges of the leaflets and the lobed portions of the frame when the leaflets are in the open position.

2. The prosthetic valve of claim 1, wherein the frame is self-expandable.

3. The prosthetic valve of claim 1, wherein the frame comprises an outflow end portion and an inflow end portion, wherein the outflow end portion defines the commissure attachment portions and the lobed portions, and the inflow portion comprises a conical shape that tapers from the inlet end of the frame to an inlet end of the outflow end portion.

4. The prosthetic valve of claim 1, wherein the upper edge of each leaflet is scalloped.

5. The prosthetic valve of claim 1, wherein the frame is configured such that a distance between adjacent commissure attachment portions remains substantially constant when the lobed portions are compressed radially a predetermined amount.

6. The prosthetic valve of claim 1, wherein the commissure attachment portions are deflectable for flexing inwardly and outwardly relative to the lobed portions of the frame when the leaflets move between the closed and open positions, respectively, during operation of the prosthetic valve.

7. A prosthetic valve comprising:

a radially collapsible and expandable annular frame, the frame comprising an inlet portion and an outlet portion, the outlet portion comprising a plurality of angularly spaced, cantilevered commissure attachment posts extending radially inwardly toward a longitudinal flow axis of the prosthetic valve, the frame further comprising an intermediate portion between the inlet portion and the outlet portion, the intermediate portion having an enlarged inlet end of a first diameter, a middle section having a second diameter less than the first diameter, and an enlarged outlet end of a third diameter greater than the second diameter; and

a leaflet structure comprising a plurality of leaflets, each leaflet comprising opposing side portions, a scalloped upper edge extending between the side portions, and a scalloped lower edge extending between the side portions;

wherein each side portion is secured to an adjacent side portion of another leaflet to form commissures of the leaflet structure, each commissure being attached to one of the commissure attachment posts, the leaflets being configured to move between an open position to allow blood to flow through the prosthetic valve from the inlet portion to the outlet portion and a closed position to inhibit the flow of blood through the prosthetic valve from the outlet portion to the inlet portion, wherein the upper edges of the leaflets are spaced radially inwardly of the frame when the leaflets are in the open position such that a gap is formed between the upper edge of each leaflet and the frame.

8. The prosthetic valve of claim 7, wherein a section of the lower edge of each leaflet extends to a location proximate an inlet end of the frame.

9. The prosthetic valve of claim 7, further comprising an annular skirt positioned inside of and secured to the frame, the lower edge of each leaflet being secured to the skirt.

10. The prosthetic valve of claim 7, wherein the first diameter is the same as the third diameter.

11. The prosthetic valve of claim 10, wherein the middle section is cylindrical.

12. The prosthetic valve of claim 7, wherein the frame comprises a plurality of struts connected to each other to define a plurality of cells arranged in rows connected to each other along the length of the frame, the commissure attachment posts extending from cells of one of the rows proximate the outflow end of the frame.

13. A prosthetic valve comprising:

a radially collapsible and expandable annular frame, the frame having three angularly spaced commissure attachment posts, each commissure attachment post comprising at least two cantilevered struts spaced apart from each other to define a leaflet-receiving gap slot the frame also having three lobed portions defining a tri-lobed cross-sectional shape, each lobed portion extending between two commissure attachment posts; and

a leaflet structure comprising three leaflets, each leaflet comprising opposing side portions and an upper edge extending between the side portions, wherein each side portion is secured to an adjacent side portion of another leaflet to form commissures of the leaflet structure, each commissure extending through the leaflet-receiving gap slot of a respective commissure attachment post, wherein the struts of the commissure attachment post are compressed toward each other to clamp the commissure between the struts;

,

wherein the three lobed portions extend farther radially outwardly than the commissure attachment posts for providing artificial sinuses and for maintaining a clearance between the upper edges of the leaflets and the frame when the leaflet structure is in an open position.

14. The prosthetic valve of claim 13, further comprising a suture tightened around the struts of each commissure attachment post, thereby causing the struts to clamp the commissure between the struts.

15. The prosthetic valve of claim 13, wherein the at least two cantilevered struts of each commissure attachment post comprises two inner struts and two outer struts, a first leaflet-receiving slot defined between the inner struts, a second leaflet-receiving slot defined between an inner struts and an adjacent outer strut, and a third leaflet-receiving define slot defined between the other inner strut and an adjacent outer strut, the side portions forming a commissure extending through the first leaflet-receiving slot with one of the side portions forming a fold extending into the second leaflet-receiving slot and the other of the side portions forming a fold extending into the third leaflet-receiving slot.

16. The prosthetic valve of claim 13, wherein the commissure attachment posts extend radially inwardly toward a longitudinally flow axis of the prosthetic valve.

17. A prosthetic valve comprising:

a radially collapsible and expandable annular frame, the frame being plastically expandable and comprising a plurality of angularly spaced commissure attachment posts; and

a leaflet structure comprising a plurality of leaflets, each leaflet comprising opposing side portions, wherein each side portion is secured to an adjacent side portion of another leaflet to form commissures of the leaflet structure, each commissure being attached to one of the commissure attachment posts;

wherein the commissure attachment posts are configured to deflect radially inwardly toward a longitudinal flow axis of the prosthetic valve for allowing the frame to transition from a substantially circular cross-section to a tri-lobed cross-section, the transition occurring when the commissure attachment posts are first subjected to closing forces of the leaflets and wherein the commissure attachment posts remain in a deflected position during subsequent closing and opening cycles of the prosthetic valve.

18. The prosthetic valve of claim 17, wherein the commissure attachment posts, in the deflected position, are configured to retain the upper edges of the leaflets at a position spaced radially inwardly of the frame when the leaflets are in the open position such that a clearance is provided between the upper edge of each leaflet and the frame.

19. The prosthetic valve of claim 17, wherein the frame comprises a row of a plurality of angled struts interconnecting the commissure attachment posts at an outflow end of the frame, the plurality of struts comprising struts connected directly to the commissure attachment posts and struts that are not connected directly to the commissure attachment posts, the struts that are connected directly to the commissure attachment posts being relatively more flexible than the struts that are not connected directly to the commissure attachment posts.