Cloth-covered stents for tissue heart valves

• US 6,585,766 B1
• Filed: 06/22/2000
• Issued: 07/01/2003
• Est. Priority Date: 03/27/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Than, Huynh, Van Le, Kafesjian, Ralph, Guo, Xiaoming G., Lam, Hung Ly
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/599,200
• Time in Patent Office: 1,104 Days
• Field of Search: 623/2.1, 623/2-2-, 623/2.38, 623/2.4, 623/2.42, 623/900, 623/910
• US Class Current: 623/2.38
• 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 stent for use in a heart valve, comprising:

a substantially circular and radially stable support member having an upper edge defining a plurality of upwardly projecting flexible posts, wherein the support member includes an inner support member and an outer support member, the outer support member being configured to receive the inner support member for attachment therein, the plurality of flexible posts being formed on the inner support member, wherein the outer support member also includes a plurality of posts each of which are aligned with yet truncated with respect to the flexible posts of the inner support member, and

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

2. The stent of claim 1 wherein the outer support member is substantially rigid such that the circular support member is substantially rigid at all points except at the upwardly projecting flexible posts formed on the inner support member.

3. The stent of claim 1 wherein the inner and outer support members further have a plurality of aligned sewing holes, and wherein the support members are attached with thread through at least one pair of the aligned sewing holes.

4. The stent of claim 1, wherein the cloth covering comprises an outer layer and an inner layer, the layers being formed out of a single piece of cloth and having free edges sewn together at the upper edge of the support member.

5. The stent of claim 4, further including a sewing edge formed by folding and stitching together the free edges of the cloth at the upper edge of the support member.

6. The stent of claim 5, wherein the inner layer extends upward beyond the outer layer and is folded outward to form the sewing edge.

7. The stent of claim 6, wherein the inner layer extends upward beyond the outer layer by approximately 2 mm.

8. The stent of claim 7, wherein the sewing edge extends along the entire upper edge, including over tips of the flexible posts.

9. A method of making a stent for use in a heart valve, the method comprising the steps of:

providing a substantially circular and radially stable support member having an upper edge defining a plurality of upwardly projecting flexible posts, the support member includes an inner support member and an outer support member, the outer support member being configured to receive the inner support member therein, the plurality of flexible posts being formed on the inner support member, wherein the outer support member also includes a plurality of posts each of which is truncated with respect to the flexible post of the inner support member;

placing the inner support member within the outer support member and aligning the posts of the support members;

attaching the aligned support members together;

providing a cloth covering; and

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

10. The method of claim 9 wherein:

said support members further have a plurality of sewing holes; and

said attaching step includes the steps of;

aligning the sewing holes of the support members;

inserting a needle with thread through at least one pair of the aligned sewing holes; and

securing the thread so as to attach the support members together.

11. The method of claim 9, wherein the cloth covering comprises a single piece, and the method further includes folding the single piece around a lower edge of the support member and sewing together free edges of the single piece at the upper edge.

12. The method of claim 11, further including forming a sewing tab at the upper edge of the support member by folding and stitching the free edges of the single piece.

13. The method of claim 9 wherein the cloth covering comprises an outer layer and an inner layer connected at a lower edge of the support member, the inner and outer layers having free edges extending upward beyond the upper edge of the support member, and further including forming a sewing tab at the upper edge of the support member by folding and stitching the free edges of the inner and outer layers.

14. The method of claim 13, wherein the free edge of the inner layer extends upward beyond the free edge of the outer layer, the method including folding the free edge of the inner layer outward over the outer layer to form the sewing edge.

15. The method of claim 14, wherein the free edge of the inner layer extends upward beyond the free edge of the outer layer by approximately 2 mm.