Heart valves with increased effective orifice area

• US 10,441,415 B2
• Filed: 09/17/2014
• Issued: 10/15/2019
• Est. Priority Date: 09/20/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Johnson, Derrick, Le Huynh, Van, Zeng, Qinggang
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/488,728
• Publication Number:
  US 20150088250A1
• Time in Patent Office: 1,854 Days
• 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 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00389 The prosthesis being coated or covered with a particular material

Abstract

A prosthetic heart valve for implant in a human. The valve includes a wireform with undulating inflow cusps and outflow commissure posts to which flexible leaflets attach and coapt in a flow area. Each leaflet may drape over the top of the wireform in the cusp area, but have tabs that each extend underneath the wireform at the commissure posts to be secured along with a tab of an adjacent leaflet. The prosthetic heart valve may also be a dual-wire wireform, with the leaflets sandwiched therebetween. One wireform may be larger than the other, with the leaflets extending over the smaller wireform. The smaller wireform may have commissures that bend radially outward from the larger wireform to provide structure to which the leaflet tabs attach.

Claims

1. A prosthetic heart valve, comprising:

a first undulating wireform comprising an elongated rod-like structure having a peripheral shape continuously alternating around a central axis, three curvilinear cusps on an inflow end and three curvilinear commissures on an outflow end;

a second undulating wireform comprising an elongated rod-like structure having a peripheral shape continuously alternating around the axis, three curvilinear cusps on an inflow end and three curvilinear commissures on an outflow end, wherein the first and second wireforms are separate elements,

wherein the cusps and commissures of the two wireforms are circumferentially aligned around the axis with the aligned cusps positioned adjacent to one another while the commissures of the first wireform are shorter in height than the commissures of the second wireform, and wherein the heart valve has no rigid annular components; and

wherein the heart valve has no rigid annular components; and

a plurality of flexible leaflets having outer edges secured at the cusps of the first and second undulating wireforms, wherein the cusps of the first wireform are located axially below the cusps of the second wireform and the outer edges of the flexible leaflets are secured therebetween.

2. The heart valve of claim 1, wherein both the first wireform and second wireform are covered with fabric and wherein the flexible leaflets have commissure tabs that extend outward through the inverted U-shaped commissures of the second fabric-covered wireform and are secured to cloth tabs extending from the fabric covering on the second wireform.

3. The heart valve of claim 1, wherein a cross-sectional shape through the first wireform is dissimilar from a cross-sectional shape through the second wireform.

4. The heart valve of claim 1, wherein both the first wireform and second wireform are covered with fabric and the outer edges of the flexible leaflets are secured between the respective cusps with sutures.

5. The heart valve of claim 1, wherein the flexible leaflets each have commissure tabs that extend outward through the commissures of the second wireform and are secured to cloth tabs extending from a cloth covering on the second wireform.

6. The heart valve of claim 5, wherein an assembly of the leaflet commissure tabs and cloth tabs on adjacent portions of each commissure of the second cloth-covered wireform is rolled or folded and sewn together outside of that commissure.

7. The heart valve of claim 1, wherein both the first wireform and second wireform are covered with fabric and a cloth tab on one of the wireforms encompasses a small piece of silicone ribbon at least at the cusps thereof to provide a sewing ring.

8. The heart valve of claim 1, wherein the cusps of both wireforms curve in an inflow direction and the commissures of the second wireform define upstanding commissure posts with inverted U-shapes projecting in an outflow direction, and the commissures of the first wireform are about one half the height of the commissures of the second wireform.

9. The heart valve of claim 1, wherein both the first wireform and second wireform are separately covered with fabric and then joined with sutures with outer edges of the flexible leaflets sandwiched therebetween.

10. The heart valve of claim 1, wherein both the first wireform and second wireform are formed of the same material.

11. A prosthetic heart valve, comprising:

a first undulating wireform comprising a preformed wire having a peripheral shape continuously alternating around a central axis, three curvilinear cusps on an inflow end and three curvilinear commissures on an outflow end;

a second undulating wireform comprising a preformed wire having a peripheral shape continuously alternating around the axis, three curvilinear cusps on an inflow end and three curvilinear commissures on an outflow end, wherein the first and second wireforms are separate elements;

wherein the cusps and commissures of the two wireforms are circumferentially aligned around the axis with the aligned cusps positioned adjacent to one another while the commissures of the first wireform are shorter in height than the commissures of the second wireform, and wherein the heart valve has no rigid annular components; and

wherein the heart valve has no rigid annular components; and

a plurality of flexible leaflets having outer edges secured at the cusps of the first and second undulating wireforms, wherein the second wireform is located axially above the first wireform with no axially overlapping portions.

12. The heart valve of claim 11, wherein both the first wireform and second wireform are covered with fabric and the outer edges of the flexible leaflets are secured between the respective cusps with sutures.

13. The heart valve of claim 11, wherein the cusps of both wireforms curve in an inflow direction and the commissures of the second wireform define upstanding commissure posts with inverted U-shapes projecting in an outflow direction, and the commissures of the first wireform are about one half the height of the commissures of the second wireform.

14. The heart valve of claim 11, wherein both the first wireform and second wireform are formed of the same material.

15. The heart valve of claim 11, wherein both the first wireform and second wireform are separately covered with fabric and then joined with sutures with outer edges of the flexible leaflets sandwiched therebetween.

16. The heart valve of claim 11, wherein the flexible leaflets each have commissure tabs that extend outward through the commissures of the second wireform and are secured to cloth tabs extending from a cloth covering on the second wireform.

17. The heart valve of claim 16, wherein an assembly of the leaflet commissure tabs and cloth tabs on adjacent portions of each commissure of the second cloth-covered wireform is rolled or folded and sewn together outside of that commissure.

18. The heart valve of claim 11, wherein both the first wireform and second wireform are covered with fabric and a cloth tab on one of the wireforms encompasses a small piece of silicone ribbon at least at the cusps thereof to provide a sewing ring.

19. The heart valve of claim 11, wherein the first and second undulating wireforms are cloth-covered, and the outer edges of the flexible leaflets are sandwiched between the cusps of the first and second wireforms.

20. The heart valve of claim 11, wherein the cusps of both wireforms curve in an inflow direction and the commissures of the second wireform define upstanding commissure posts with inverted U-shapes projecting in an outflow direction, and the first wireform has truncated commissures of about one half the height of the commissures of the second wireform.