Minimally-invasive heart valves and methods of use

• US 6,767,362 B2
• Filed: 06/28/2002
• Issued: 07/27/2004
• Est. Priority Date: 04/06/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Schreck, Stefan
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/185,812
• Publication Number:
  US 20020198594A1
• Time in Patent Office: 760 Days
• Field of Search: 623/900, 623/2.11, 623/2.12, 623/2.13, 623/2.14, 623/2-5-, 623/2.1, 623/1.24, 623/1.26
• US Class Current: 623/2.11
• 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, comprising:

providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, and wherein a plurality of prosthetic leaflets are 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 to the stent substantially entirely along the cusp edge and at bath commissure portions in a manner that provides continuous support for each leaflet along the cusp edge, with a coapting edge remaining unattached, wherein the stent comprises a wireform defining alternating commissures and arcuate cusps, the cusp edge of each prosthetic leaflet being attached along a wireform cusp, wherein the commissure portions of the prosthetic leaflets terminate in outwardly extending tabs that each attach to a wireform commissure, and wherein tabs from adjacent leaflets are attached together at each of the wireform commissures;

storing the stent in an expanded configuration;

compressing the stent just prior to implantation;

delivering the compressed stent through a tube to a heart valve annulus; and

expanding the stent so that the leaflets form a one-way valve at the heart valve annulus.

2. The method of claim 1, further including:

providing an annular tissue-engaging base, the base being expandable from a collapsed state;

connecting the wireform and leaflets to the base to form a heart valve;

delivering the heart valve with the connected base in its collapsed state and wireform in its compressed size to an annulus of the patient'"'"'s heart valve being replaced; and

expanding the base into its 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 3, including the step of expanding the tissue-engaging base by inflating a balloon within the tissue-engaging base.

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

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

7. The method of claim 6, wherein the step of delivering the compressed stent through a tube to the annulus is accomplished by passing the valve through a catheter introduced into the femoral artery and advanced through the iliac artery, abdominal aorta and aortic arch.

8. The method of claim 1, wherein the step of delivering the compressed stent through a tube to the annulus is accomplished via a minimally-invasive port in the patient'"'"'s chest.

9. The method of claim 1, wherein the tabs from adjacent leaflets extend outward between spaced wires of the wireform commissure, 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 commissure are spaced apart so as to maintain the leaflet tabs on the outside of the wireform commissure.

11. The method of claim 4, further including:

providing an annular tissue-engaging base, the base being expandable from a collapsed state;

connecting the stent and leaflets to the base to form a heart valve;

delivering the heart valve with the connected base in its collapsed state and stent in its compressed size to an annulus of the patient'"'"'s heart valve being replaced; and

expanding the base into its expanded state in contact with the annulus.

10. A method of minimally-invasive heart valve replacement surgery on a patient, comprising:

providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, the stent defining a plurality of upstanding commissures and a plurality of arcuate cusps, one cusp each between adjacent commissures, wherein a plurality of prosthetic leaflets are attached to the stent along the cusps and commissures in a manner that provides continuous support for each leaflet along the stern cusps, wherein the stent and leaflets are configured to be radially compressed, wherein the stent comprises a wireform, and wherein the prosthetic leaflets each have a cusp edge attached along a wireform cusp, and the prosthetic leaflets each have 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;

storing the stent in an expanded configuration;

compressing the stent just prior to implantation;

delivering the compressed stent through a tube to a heart valve annulus; and

expanding the stent so that the leaflets form a one-way valve at the heart valve annulus.

12. The method of claim 10, wherein the tabs from adjacent leaflets extend outward between spaced wires of the wireform commissure, 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 commissure are spaced apart so as to maintain the leaflet tabs on the outside of the wireform commissure.

13. A method of minimally-invasive heart valve replacement surgery on a patient, comprising:

providing an annular tissue-engaging base, the base being expandable from a collapsed state;

providing an expandable heart valve stent adapted to be delivered in a collapsed state to an implantation site and expanded, the stent defining a plurality of upstanding commissures and a plurality of arcuate cusps, one cusp each between adjacent commissures, wherein a plurality of prosthetic leaflets are attached to the stent along the cusps and commissures in a manner that provides continuous support for each leaflet along the stent cusps, wherein the stent and leaflets are configured to be radially compressed;

storing the stent in an expanded configuration;

compressing the stent just prior to implantation;

connecting the stent to the base to form a heart valve;

delivering the heart valve with the connected base in its collapsed state and stent in its compressed size through a tube to a heart valve annulus; and

expanding the base into its expanded state in contact with the heart valve annulus and the stent so that the leaflets form a one-way valve.