Methods of tissue heart valve assembly

• US 6,102,944 A
• Filed: 03/09/1999
• Issued: 08/15/2000
• Est. Priority Date: 03/27/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen, Than, Lam, Hung Ly, Huynh, Van Le, Kafesjian, Ralph, Guo, Xiaoming G.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/264,801
• Time in Patent Office: 525 Days
• Field of Search: 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/2.18, 623/2.19, 623/2.39, 623/900, 623/910
• 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 method of making a tissue leaflet subassembly for use in a heart valve, said method comprising the steps of:

providing sheet-like tissue;

providing a planar template having a pair of oppositely directed tabs, a substantially linear edge extending between said tabs, and a substantially arcuate portion extending between said tabs;

placing said template on said tissue; and

cutting away portions of said tissue which extend beyond said template to form a tissue leaflet having a pair of opposing faces, a pair of oppositely directed tabs, a substantially straight edge extending between said tabs, and a substantially arcuate cusp edge extending between said tabs;

repeating the preceding steps to form a plurality of tissue leaflets;

attaching the tabs of said tissue leaflets to each other to form said tissue leaflet subassembly.

2. The method of claim 1 wherein:

said template has a guide slot formed in the linear edge; and

said attaching step includes the steps of;

aligning said template with a first two of said tissue leaflets, the first two tissue leaflets contacting one another; and

inserting a needle with thread through said guide slot and through said first two tissue leaflets to attach one adjacent pair of tabs of the two leaflets, the other pair of adjacent tabs being left unconnected; and

securing said thread.

3. The method of claim 2 wherein there are three leaflets in the tissue leaflet subassembly and the method further includes:

aligning said template with a third one said tissue leaflets;

separating the unconnected adjacent tabs of the two leaflets and aligning each separated tab with one of the tabs of the third leaflet; and

inserting a needle with thread through said guide slot and through said aligned tabs to complete the formation of the tissue leaflet subassembly.

4. A method of assembling an adaptable, tissue-type heart valve, said method comprising the steps of:

forming a dimensionally stable, pre-aligned tissue leaflet subassembly from a plurality of substantially identical tissue leaflets defining a subassembly peripheral edge;

providing a generally circular wireform having a bottom surface dimensioned to receive said dimensionally stable, pre-aligned tissue leaflet subassembly peripheral edge in mating engagement;

providing a generally circular support stent having an upper surface dimensioned to engage said dimensionally stable, pre-aligned tissue leaflet subassembly peripheral edge; and

clamping said dimensionally stable, pre-aligned tissue leaflet subassembly peripheral edge between said wireform bottom surface and said support stent upper surface.

5. The method of claim 4, further comprising the additional step of attaching said dimensionally stable, pre-aligned tissue leaflet subassembly peripheral edge to said bottom surface of said wireform prior to said clamping step.

6. The method of claim 5 wherein said clamping step comprises the additional steps of:

engaging said upper surface of said support stent with said attached dimensionally stable, pre-aligned tissue leaflet subassembly peripheral edge; and

attaching said support stent to said dimensionally stable, pre-aligned tissue leaflet subassembly peripheral edge and to said wireform.

7. The method of claim 6 wherein said attaching step comprises sewing.

8. The method of claim 4 further comprising the additional step of attaching an adaptable structural interface to said support stent after said clamping step.

9. A method of assembling a tissue heart valve, said method comprising:

forming a leaflet subassembly by;

providing three tissue leaflets, each of the leaflets having a pair of opposing tabs, a coapting edge extending between the opposing tabs, and a substantially arcuate cusp extending between the opposing tabs and having a peripheral edge;

mating and attaching each of the opposing tabs of each of the leaflets to a respective one of the opposing tabs of another of the leaflets, with each leaflet being attached to one tab of each of the other two leaflets, the mating leaflet tabs projecting outward therefrom;

providing a wireform having three commissures defined by two spaced apart wire sections joined at a tip, and three arcuate portions extending between adjacent pairs of the commissures, the wireform being complementary to the leaflet subassembly in size and arrangement such that each of the commissures corresponds to one of the pairs of mating leaflet tabs and that each of the arcuate portions corresponds to the arcuate cusp of one of the leaflets of the leaflet subassembly;

positioning the wireform over the leaflet subassembly with the mating leaflet tabs positioned adjacent the tip between the two spaced apart wire sections of the commissures and the arcuate portions juxtaposed with the arcuate cusps; and

attaching the leaflet subassembly to the wireform at the commissures and along the arcuate portions to form a leaflet/wireform subassembly.

10. The method of claim 9, wherein the wireform is cloth-covered and the step of attaching the leaflet subassembly to the wireform comprises suturing the leaflets to the cloth covering.

11. The method of claim 10, wherein the cloth-covered wireform has a cloth edge and the leaflet subassembly is sewn to the cloth edge of the cloth-covered wireform.

12. The method of claim 9, further comprising:

providing a generally circular support stent having upwardly extending flexible commissure posts and an upper surface, the leaflet/wireform subassembly having a complementary bottom surface;

engaging the support stent upper surface to the bottom surface of the leaflet/wireform subassembly attaching the mating leaflet tabs to the stent commissure posts.

13. The method of claim 12, wherein the stent commissure posts are positioned radially outside of the wireform commissures, and wherein the method includes:

attaching each pair of mating leaflet tabs at locations spaced from their respective radially outermost ends;

after forming the leaflet/wireform subassembly, separating the pair of tab ends outside of the spaced apart wire sections of the commissures; and

passing each separated tab end on opposite sides of the associated stent commissure and attaching them thereto so as to induce clamping of the leaflet tabs between the stent commissure posts and wireform commissures upon a radially inward force being applied to the leaflets.

14. The method of claim 13, including passing each separated tab end around the outside of the associated stent commissure post and rejoining the tab ends at a stitched butt joint.