System and method for implanting a two-part prosthetic heart valve

• US 7,381,218 B2
• Filed: 01/28/2004
• Issued: 06/03/2008
• Est. Priority Date: 04/06/2000
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schreck, Stefan
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/766,139
• Publication Number:
  US 20040186565A1
• Time in Patent Office: 1,588 Days
• Field of Search: 623/1.24, 623/1.25, 623 21- 242, 623/1.26, 623/900
• US Class Current: 623/1.26
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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

Abstract

Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves maybe implanted using a balloon catheter. Preferably, the leaflets of the heart valves are secured to the commissure regions of the expandable stents using a clamping arrangement to reduce stress.

Claims

1. A two-part prosthetic heart valve for implantation within a native heart valve, comprising:

a substantially cylindrical tissue-engagable bas portion expandable from a collapsed state to an expanded state, the collapsed state sized for delivery through a delivery catheter to a heart valve annulus and the expanded state sized to contact the heart valve annulus; and

a leaflet subassembly including a self-expandable metallic support structure and three heart valve leaflets, the leaflets being attached to the support structure at commissures, wherein the support structure has a fabric covering and the three heart valve leaflets are attached to the support structure at least in part by stitches along the fabric covering; and

mechanical coupling members on the tissue-engagable base portion and leaflet subassembly for allowing the leaflet subassembly to mechanically couple to the tissue-engagable base portion, wherein the mechanical coupling members on the tissue-engagable base portion comprising axial posts configured for connection to the mechanical coupling members on the leaflet subassembly;

wherein the tissue-engagable base portion and leaflet subassembly are separate components and the leaflet subassembly is configured to mechanically connect to the tissue-engagable base portion at the time of an implant procedure for providing a prosthetic heart valve.

2. The two-part prosthetic heart valve of claim 1, wherein the support structure comprises a wireform and wherein the three heart valve leaflets are attached to the wireform.

3. The two-part prosthetic heart valve of claim 1, wherein the support structure comprises an elastic wireform for supporting the leaflets and wherein the wireform provides alternating commissures and cusps.

4. The two-part prosthetic heart valve of claim 1, wherein the three heart valve leaflets are individual leaflets attached to the support structure separately from each other.

5. The two-part prosthetic heart valve of claim 1, wherein the three heart valve leaflets are formed of bioprosthetic tissue.

6. The two-part prosthetic heart valve of claim 1, wherein the tissue-engagable base portion is plastically-expandable from its collapsed state to its expanded state.

7. The two-part prosthetic heart valve of claim 1, wherein the tissue-engagable base portion is self expandable from its collapsed state to its expanded state.

8. A two-part prosthetic heart valve for implantation within a native heart valve, comprising:

a tissue-engagable base expandable from a collapsed state to an expanded state, the collapsed state sized for advancement through a patient'"'"'s vasculature to a heart valve annulus and the expanded state sized to engage the heart valve annulus, the tissue-engagable base having an outflow rim and plurality of commissure posts rigidly attached to extend beyond the outflow rim and a plurality of cusp posts rigidly attached to extend beyond the outflow rim;

a leaflet subassembly including a support structure and three heart valve leaflets, the leaflets being attached to the support structure at their commissures, wherein the support structure comprises an elastic wireform for supporting the leaflets and wherein the wireform provides alternating commissures and cusps; and

a plurality of discrete mating connectors on the leaflet subassembly and tissue-engagable base, one each on the leaflet subassembly and base forming a pair of mating connectors, the mating connectors configured to mechanically couple the leaflet subassembly to the tissue-engagable base when the tissue-engagable base is in the expanded state, each commissure post and cusp post having one of the mating connectors thereon for securely coupling to a matins connector on one of the commissures and cusps of the elastic wireform.

9. The two-part prosthetic heart valve of claim 8, wherein the tissue-engagable base is plastically-expandable from the collapsed state to the expanded state.

10. The two-part prosthetic heart valve of claim 8, wherein each pair of the mating connectors joins by axially displacing the leaflet subassembly toward the tissue-engagable base.

11. A two-part prosthetic heart valve for implantation within a native heart valve, comprising:

a tissue-engagable base expandable from a collapsed state to an expanded state, the collapsed state sized for advancement through a patient'"'"'s vasculature to a heart valve annulus and the expanded state sized to engage the heart valve annulus the tissue-engagable base further including an outflow rim and a plurality of commissure posts rigidly attached to the tissue-engagable base so as to extend generally axially beyond the outflow rim and a plurality of cusp posts rigidly attached to the tissue-engagable base so as to extend be and the outflow rim;

an expandable leaflet subassembly including a support structure and three heart valve leaflets, the leaflets being attached to the support structure at their commissures, the leaflet, subassembly being expandable from a collapsed state to an expanded state, wherein the support structure comprises an elastic wireform with alternating commissures and cusps for supporting the leaflets; and

a plurality of axially extending discrete mating connectors on the leaflet subassembly and tissue-engagable base on each on the leaflet subassembly and base forming pair of m ting connectors, wherein each commissure post and cusp post of the tissue-engagable base has one of the mating connectors thereon for securely coupling to a mating connector on one of the commissures and cusps of the elastic wireform, wherein axial displacement of the leaflet subassembly in its expanded state toward the expanded tissue-engagable base in its expanded state actuates a mutual coupling mechanism on the pairs of mating connectors so as to mechanically couple the leaflet subassembly to the tissue-engagable base.

12. The two-part prosthetic heart valve of claim 11, wherein the tissue-engagable base is plastically-expandable from the collapsed state to the expanded state.

13. The two-part prosthetic heart valve of claim 11, wherein mating connectors on the leaflet subassembly are provided on each of the commissures and cusps of the elastic wireform.

14. The two-part prosthetic heart valve of claim 11, wherein the mating connectors are joined together by axial compression.

15. The two-part prosthetic heart valve of claim 14 wherein the mating connectors are configured to snap fit together.

16. The two-part prosthetic heart valve of claim 14, wherein one of each pair of mating connectors comprises a partial circle opening in an axial direction toward the other of the pair.