Contoured heart valve suture rings

• US 20060009842A1
• Filed: 08/12/2005
• Published: 01/12/2006
• Est. Priority Date: 03/27/1997
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Lam, Hung Ly, Nguyen, Than, Huynh, Van Le, Kafesjian, Ralph, Guo, Xiaoming G.
• Granted Patent: US 8,518,108 B2
• Time in Patent Office: Days
• US Class Current: 623/2.410
• 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 suture ring comprising a suturable annulus having a compliant internal member and a cloth covering, and three evenly spaced upwardly opening depressions formed on an internal circumference of the suturable annulus.

2. The suture ring of claim 1, wherein the compliant internal member has an upwardly facing outer ledge and three inner lips projecting up from the ledge in between which the depressions are formed.

3. The suture ring of claim 2, further comprising a ring washer sized to rest on the ledge and closely surround the inner lips.

4. The suture ring of claim 3, 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.

5. The suture ring of claim 3, wherein the cloth covering surrounds the sponge member and extends between the ring washer and the sponge member.

6. The suture ring of claim 5, 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.

7. The suture ring of claim 1, wherein the compliant internal member comprises a sponge member and the ring washer is a non-woven polyester.

8. The suture ring of claim 1, wherein the cloth covering is secured to the compliant internal member with stitching along the contours of the depressions.

9. A prosthetic heart valve suture ring comprising an annular internal member defined by a contoured inner wall having a plurality of upwardly opening depressions formed thereon alternating with the same number of walled lips that extend upward from an upwardly facing ledge disposed outward from the walled lips.

10. The suture ring of claim 9, further comprising a ring washer sized to closely surround the walled lips and rest on the ledge.

11. The suture ring of claim 10, wherein the cloth covering comprises a single piece of cloth surrounding the annular internal member, folded around the external surfaces of the ring washer and tucked between the ring washer and the annular internal member.

12. The suture ring of claim 10, wherein the cloth covering surrounds the annular internal member and extends between the ring washer and the annular internal member.

13. The suture ring of claim 9, wherein the annular internal member comprises a molded sponge member and the ring washer is a non-woven polyester.

14. The suture ring of claim 9, wherein the cloth covering is secured to the compliant internal member with stitching along the contours of the depressions.

15. A prosthetic heart valve suture ring comprising an annular internal member defined by a contoured inner wall having a plurality of walled lips that extend upward from an upwardly facing ledge disposed outward therefrom, and a ring washer sized to closely surround the walled lips and rest on the ledge.

16. The suture ring of claim 15, further including a cloth covering surrounding the annular internal member, and folded around the external surfaces of the ring washer and tucked between the ring washer and the annular internal member.

17. The suture ring of claim 16, wherein the inner diameter of the ring washer is greater than the outer diameter of the walled lips of the annular internal member such that a radial space is formed between the ring washer and the walled lips, and further including stitching applied in the radial space between the walled lips and ring washer to attach the cloth covering that extends between the ring washer and the annular internal member to the annular internal member.

18. The suture ring of claim 15, wherein the annular internal member comprises a molded sponge member and the ring washer is a non-woven polyester.

19. The suture ring of claim 15, wherein there are three of the walled lips and the annular internal member further includes three upwardly opening depressions formed between the walled lips.

20. The suture ring of claim 19, wherein the cloth covering is secured to the annular internal member with stitching along the contours of the depressions.