Heart valves and suture rings therefor

• US 20030195620A1
• Filed: 04/11/2003
• Published: 10/16/2003
• Est. Priority Date: 03/27/1997
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Than, Lam, Hung Ly, Huynh, Van Le, Kafesjian, Ralph, Guo, Xiaoming G.
• Granted Patent: US 6,945,997 B2
• Time in Patent Office: Days
• US Class Current: 623/2.14
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/91 Heart

Abstract

Improved, adaptable tissue-type heart valves and methods for their manufacture are disclosed wherein a dimensionally stable, pre-aligned tissue leaflet subassembly is formed and its peripheral edge clamped between and attached to an upper shaped wireform and a lower support stent. A variety of adaptable structural interfaces including suture rings, flanges, and conduits may be attached to the support stent with or without an outlet conduit disposed about the wireform to provide a tissue-type heart valve adaptable for use in either a natural heart or in mechanical pumping devices. The methods include forming individual leaflets with a template and using the template to attach the leaflets together to form a tissue leaflet subassembly. The template and leaflets include a straight edge terminating in oppositely directed tabs, and a curvilinear cusp edge extending opposite the straight edge. The template may include a guide slot in its straight edge and the assembly includes aligning two leaflet tabs with the template and passing sutures through the guide slot and through the leaflet tabs. The leaflet subassembly is mated to a wireform with the tabs extending through commissure posts of the wireform. A support stent having an upper surface matching the lower surface of the wireform sandwiches the edges of the leaflet subassembly therebetween. Separated tabs on the leaflet subassembly are passed through the wireform commissures and attached to adjacent stent commissures so as to induce clamping of the leaflet tabs between the stent commissures and wireform commissures upon a radially inward force being applied to the leaflets.

Claims

1. A prosthetic heart valve comprising:

a valve including a plurality of flexible leaflets whose outer edges attach to a support structure having a plurality of axially projecting commissures terminating in tips, the commissures being separated by arcuate cusps, the commissures and tips defining a generally sinusoidal line with the commissures extending in the outflow direction and the cusps extending in the inflow direction; and

a suture ring fixedly disposed upon an inflow end of the valve comprising a suturable annulus having upwardly opening depressions on an internal circumference corresponding in number to the number of cusps of the support structure, wherein the suture ring has a bore sized to receive the cusps in the depressions.

2. The valve of claim 1, wherein the suture ring comprises a sponge waffle covered with cloth.

3. The valve of claim 2, wherein the sponge waffle comprises an upwardly facing outer ledge and an inner lip projecting up from the ledge in which the depressions are formed.

4. The valve of claim 3, further comprising a ring washer sized to closely surround the lip and rest on the ledge.

5. The valve of claim 4, further comprising a single cloth covering surrounding the sponge waffle, and folded around the external surfaces of the ring washer and tucked between the ring washer and the sponge waffle.

6. The valve of claim 4, further comprising a cloth covering surrounding the sponge waffle and extending between the ring washer and the sponge waffle.

7. The valve of claim 1, wherein the suture ring comprises a sponge waffle in combination with a non-woven polyester ring washer, and a cloth covering, to form a stable suture ring which functions as a compliant, stitchable interface between the natural tissues of the heart and the prosthetic heart valve.

8. The valve of claim 1, wherein the suture ring comprises a compliant internal structure and a cloth covering, and the cloth covering is secured to the contour of the depressions.

9. The valve of claim 1, wherein the plurality of flexible leaflets includes:

a tissue leaflet subassembly attached within the support stucture and formed by a plurality of substantially identical tissue leaflets, each of the leaflets having a coapting mating edge having opposing ends and a generally arcuate peripheral cusp extending therebetween coupled to one of the support stucture cusps.

10. The valve of claim 1, wherein the support structure comprises

an annular wireform having a plurality of axially projecting outflow commissures terminating in arcuate tips, the commissures being separated by arcuate cusps having a substantially larger radius of curvature than the tips, the commissures and tips being formed in a sinusoidal configuration with the commissures extending in the opposite axial direction from the cusps so that each commissure is defined by spaced apart portions of the wireform in adjacent cusps joined by one of the tips.

11. The valve of claim 10, wherein the support structure further comprises:

a generally cylindrical support stent having an upper edge defining a plurality of upwardly projecting flexible posts and arcs therebetween adapted to conform and attach to the wireform commissures and arcuate cusps; and

a cloth covering sewn over the stent such that the cloth covering encloses the support member and substantially conforms to the shape of the support member.

12. The stent of claim 11 wherein the cloth covering comprises a sewing edge formed by folding and stitching together portions of the cloth covering at the upper edge of the support member.

13. The stent of claim 12, wherein the sewing edge extends along the entire upper edge, including over the flexible posts.

14. A prosthetic heart valve suture ring comprising a suturable annulus having a compliant internal structure and a cloth covering, and upwardly opening depressions formed on an internal circumference of the suturable annulus.

15. The suture ring of claim 14, wherein the compliant internal structure comprises a sponge waffle.

16. The suture ring of claim 15, wherein the sponge waffle is silicone.

17. The suture ring of claim 14, wherein the compliant internal structure comprises a sponge member having an upwardly facing outer ledge and an inner lip projecting up from the ledge in which the depressions are formed.

18. The suture ring of claim 17, further comprising a ring washer sized to closely surround the lip and rest on the ledge.

19. The suture ring of claim 18, wherein the cloth covering comprises a single piece of cloth surrounding the sponge member, and folded around the external surfaces of the ring washer and tucked between the ring washer and the sponge member.

20. The suture ring of claim 18, further including stitching attaching the cloth covering, sponge member and ring washer and placed approximately 1 mm from the outer circumferential edge of the ring washer.

21. The suture ring of claim 18, wherein the cloth covering surrounds the sponge member and extends between the ring washer and the sponge member.

22. The suture ring of claim 21, wherein the inner diameter of the ring washer is greater than the outer diameter of the inner lip of the sponge member such that a radial space is formed between the ring washer and the inner lip, and further including stitching applied in the radial space between the inner lip and ring washer to attach the cloth covering that extends between the ring washer and the sponge member to the sponge member.

23. The suture ring of claim 14, wherein the compliant internal structure comprises a sponge member in combination with a non-woven polyester ring washer.

24. The suture ring of claim 14, wherein the cloth covering is secured to the contour of the depressions.