METHODS OF IMPLANTING TWO-PART HEART VALVES

• US 20080188929A1
• Filed: 04/08/2008
• Published: 08/07/2008
• Est. Priority Date: 04/06/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schreck, Stefan
• Granted Patent: US 8,092,518 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• 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 may be 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 method of minimally-invasive heart valve replacement surgery on a patient using a two-part heart valve, comprising:

providing an expandable heart valve subassembly having an undulating elastic wireform defining a plurality of alternating upstanding commissures and arcuate cusps, and a plurality of prosthetic leaflets attached to the wireform, 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 to the wireform substantially entirely along the cusp edge and at both commissure portions, with a coapting edge remaining unattached;

storing the valve subassembly by itself in an expanded configuration;

compressing the valve subassembly just prior to implantation;

delivering the compressed valve subassembly to a heart valve annulus;

expanding the valve subassembly; and

coupling the valve subassembly to a separate annular tissue-engaging base to form the two-part heart valve wherein the leaflets permit one-way flow through the annulus.

2. The method of claim 1, wherein the tissue-engaging base is expandable from a collapsed state, and the method includes expanding the base into an expanded state in contact with the annulus.

3. The method of claim 2, wherein the tissue-engaging base is plastically-expandable from its collapsed state to its expanded state.

4. The method of claim 2, wherein the tissue-engaging base is self-expandable from its collapsed state to its expanded state.

5. The method of claim 1, wherein the step of delivering the compressed valve subassembly to the annulus is accomplished by passing the valve subassembly through the patient'"'"'s vasculature.

6. The method of claim 5, wherein the step of delivering the compressed valve subassembly to the annulus is accomplished by passing the valve subassembly through a catheter introduced into a peripheral artery.

7. The method of claim 1, wherein the step of delivering the compressed valve subassembly the annulus is accomplished via a minimally-invasive port in the patient'"'"'s chest.

8. The method of claim 1, wherein the tissue-engaging base has a plurality of axial posts extending in an outflow direction each having a commissure connector on an outflow end thereof, and each commissure of the heart valve subassembly wireform has a connector thereon configured for mating with one of the commissure connectors on the tissue-engaging base to form a pair of mating connectors.

9. The method of claim 8, wherein the mating connectors are joined together by axial compression.

10. The method of claim 8, wherein the mating connectors are configured to snap fit together.

11. A method of heart valve replacement surgery on a patient, comprising:

providing a detachable two-part heart valve, each part being expandable from a collapsed state, comprising;

a generally annular tissue-engaging base having a plurality of axial posts extending in an outflow direction each having a commissure connector on an outflow end thereof and

a heart valve subassembly having an undulating elastic wireform defining a plurality of alternating upstanding commissures and arcuate cusps, each commissure having a connector thereon configured for mating with one of the commissure connectors on the tissue-engaging base to form a pair of mating connectors, the heart valve subassembly further having a plurality of prosthetic leaflets attached to the wireform;

delivering the base in its collapsed state to an annulus of the patient'"'"'s heart valve being replaced;

expanding the base into its expanded state in contact with the annulus; and

connecting the mating connectors on the tissue-engaging base and heart valve subassembly to form the heart valve.

12. The method of claim 11, further including:

storing the two parts of the heart valve in separate sterile containers; and

connecting the two parts to form a heart valve just prior to the surgery.

13. The method of claim 11, wherein the step of delivering the base to the annulus is accomplished by passing the valve through the patient'"'"'s vasculature.

14. The method of claim 13, wherein the step of delivering the base to the annulus is accomplished by passing the valve through a catheter introduced into a peripheral artery.

15. The method of claim 11, wherein the step of delivering the base to the annulus is accomplished via a minimally-invasive port in the patient'"'"'s chest.

16. The method of claim 11, wherein the tissue-engaging base is plastically-expandable from its collapsed state to its expanded state.

17. The method of claim 11, wherein connectors on the leaflet subassembly are also provided on each of the cusps of the elastic wireform, the tissue-engaging base having a plurality of axial posts extending in an outflow direction at a mid-point of each cusp and having a cusp connector on an outflow end thereof.

18. The method of claim 11, wherein the mating connectors are joined together by axial compression.

19. The method of claim 11, wherein the mating connectors are configured to snap fit together.

20. The method of claim 11, wherein one of each pair of mating connectors comprises a partial circle opening in an axial direction toward the other of the pair.