Minimally-invasive heart valves with wireforms

• US 20040186565A1
• Filed: 01/28/2004
• Published: 09/23/2004
• Est. Priority Date: 04/06/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Stefan Schreck
• Inventors: Schreck, Stefan
• Granted Patent: US 7,381,218 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 minimally-invasive heart valve for implantation at a host heart valve annulus, comprising:

a collapsible and expandable heart valve stent adapted to be delivered in a collapsed state to the heart valve annulus and expanded in position at the annulus, the stent defining a plurality of upstanding commissures and a plurality of arcuate cusps, each cusp extending between adjacent commissures; and

a plurality of prosthetic leaflets attached to the stent, each leaflet having an approximately semi-circular cusp edge terminating at each end in commissure portions and a coapting edge extending between the commissure portions, each leaflet being attached substantially entirely along its cusp edge to one of the stent cusps and each leaflet being attached at its commissure portions to adjacent stent commissures with the coapting edge remaining unattached.

2. The heart valve of claim 1, wherein the stent comprises a generally annular elastic wireform oriented around a flow axis with the upstanding commissures projecting generally in an outflow direction.

3. The heart valve of claim 2, further including:

an annular tissue-engaging base separate from the wireform and expandable from a collapsed state to an expanded state, wherein the wireform and leaflets are connected to the base.

4. The heart valve of claim 3, wherein the tissue-engaging base is plastically-expandable from the collapsed state to the expanded state.

5. The heart valve of claim 3, wherein the wireform attaches to the base at discrete locations so as to couple each of the commissures and cusps of the elastic wireform to the base.

6. The heart valve of claim 1, wherein the prosthetic leaflets each have a cusp edge attached along a wireform cusp and a pair of commissure portions terminating in outwardly extending tabs that each attach to a wireform commissure, wherein tabs from adjacent leaflets are attached together at each of the wireform commissures.

7. The heart valve of claim 6, wherein the tabs from adjacent leaflets extend outward between spaced wires of the wireform commissures, and wherein inserts are provided around which the adjacent leaflet tabs wrap and are secured, the inserts being size larger than the distance that the wires of the wireform commissures are spaced apart so as to maintain the leaflet tabs on the outside of the wireform commissures.

8. The heart valve of claim 1, wherein the prosthetic leaflets are formed and attached to the stent separately from each other.

9. The heart valve of claim 1, wherein the stent has a fabric covering and the leaflets attach to the stent by being stitched along the fabric covering.

10. An expandable prosthetic heart valve for placement in a host heart valve annulus, comprising:

a collapsible and expandable stent system adapted to be delivered in a collapsed state to an implantation site and expanded, the stent system including an expandable generally annular tissue-engaging base and an elastic generally annular wireform attached to the base, the wireform defining a plurality of upstanding commissures and a plurality of arcuate cusps, each cusp extending between adjacent commissures; and

a plurality of prosthetic leaflets attached to the wireform in a manner that provides continuous support for each leaflet along the wireform cusps.

11. The heart valve of claim 10, wherein the tissue-engaging base is plastically-expandable from a collapsed state to an expanded state.

12. The heart valve of claim 10, wherein the wireform attaches to the base at discrete locations so as to couple each of the commissures and cusps of the elastic wireform to the base.

13. The heart valve of claim 10, wherein the commissure portions of the prosthetic leaflets terminate in outwardly extending tabs that each attach to a wireform commissure, wherein tabs from adjacent leaflets are attached together at each of the wireform commissures.

14. The heart valve of claim 13, wherein the tabs from adjacent leaflets extend outward between spaced wires of the wireform commissures, and wherein inserts are provided around which the adjacent leaflet tabs wrap and are secured, the inserts being size larger than the distance that the wires of the wireform commissures are spaced apart so as to maintain the leaflet tabs on the outside of the wireform commissures.

15. The heart valve of claim 10, wherein the prosthetic leaflets are formed and attached to the wireform separately from each other.

16. The heart valve of claim 10, wherein the generally annular wireform is oriented around a flow axis with the upstanding commissures projecting generally in an outflow direction and defining the outflow end of the heart valve.

17. The heart valve of claim 10, wherein the wireform has a fabric covering and the leaflets attach to the wireform by being stitched along the fabric covering.