Minimally-invasive heart valves and methods of use

• US 6,454,799 B1
• Filed: 04/06/2000
• Issued: 09/24/2002
• 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): McDermott, Corrine
• Assistant Examiner(s): Miller, Cheryl L.
• Application Number:
  US09/549,413
• Time in Patent Office: 901 Days
• Field of Search: 623/2.1, 623/2.14, 623/2.17, 623/2.18, 623/2.38, 623/2.33, 623/2.23, 623/2.28
• 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 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 prosthetic heart valve, comprising:

a support stent including a tubular base along an inflow end and a plurality of generally axially-extending commissure posts disposed evenly around the tubular base on an outflow end thereof, each commissure post having an axial slot, wherein the base is plastically-expandable from a first size adapted for minimally invasive delivery, to a second, functional size that fits within a heart valve annulus; and

a flexible tubular member having a prosthetic section attached to the commissure posts so as to define a plurality of prosthetic valve leaflets between the posts, and a fabric section connected to the base, and wherein the tubular member is primarily located within the posts except for a plurality of loops that extend outward through each slot on each post, and further including a plurality of inserts sized lager than the slots, each of which insert is captured within a loop extending outward through each slot to retain the loop through the slot.

2. The heart valve of claim 1, wherein the prosthetic section and fabric section are both generally tubular and attached together at a seam.

3. The heart valve of claim 2, wherein the seam is spaced from the outflow end of the tubular base so that only the fabric section of the flexible tubular member contacts the tubular base.

4. The heart valve of claim 2, wherein the seam is other than circular.

5. The heart valve of claim 1, wherein the fabric section of the flexible tubular member attaches along a seam to the outflow end of the tubular base.

6. The heart valve of claim 1, wherein the prosthetic section of the flexible tubular member is pericardial tissue.

7. The heart valve of claim 1, wherein the commissure posts are integrally formed with the base, the base and commissure posts being initially formed from a flat section of material, wherein the commissure posts initially extend from the inflow end of the base and are bent 180°

to extend alongside the base and project beyond the base at the outflow end thereof.

8. The heart valve of claim 7, wherein the fabric section of the flexible tubular member extends around the exterior of the tubular base and within spaces created between each of the commissure posts and the tubular base.

9. The heart valve of claim 1, wherein the commissure posts each comprise:

a first axial section extending from the inflow end of the base and spaced radially therefrom;

a second axial section defining the outflow extent of the post and a portion of the axial slot, the second section being radially inwardly offset from the first section; and

a transition region between the first and second sections, wherein an enlarged portion of the axial slot is defined in the transition region.

10. The heart valve of claim 1, further including a plurality of stitches securing each loop of the flexible tubular member to the corresponding insert.

11. The heart valve of claim 10, further including stitching securing each insert to the corresponding commissure post of the base.

12. A prosthetic heart valve, comprising:

a support stent including a tubular base along an inflow end and a plurality of generally axially-extending commissure posts each having an axial slot and being disposed evenly around the tubular base on an outflow end thereof; and

a flexible tubular member having an outflow edge,

wherein the tubular member is primarily located within the posts except for a plurality of loops that extend outward through each slot on each post, and further including a plurality of inserts sized larger than the slots, each of which insert is captured within a loop extending outward through each slot to retain the loop through the slot, the outflow edge of the tubular member defining a plurality of valve leaflets.

13. The heart valve of claim 12, wherein the tubular base is plastically-expandable from a first size adapted for minimally invasive delivery, to a second, functional size that fits within a heart valve annulus.

14. The heart valve of claim 12, wherein the commissure posts are integrally formed with the base, the base and commissure posts being initially formed from a flat section of material, wherein the commissure posts initially extend from the inflow end of the base and are bent 180 degrees to extend alongside the base and project beyond the base at the outflow end thereof.

15. The heart valve of claim 12, wherein the flexible tubular member has a prosthetic section attached to the commissure posts and a fabric section connected to the base at a seam.

16. The heart valve of claim 15, wherein the seam is other than circular.

17. The heart valve of claim 15, wherein the fabric section of the flexible tubular member extends around the exterior of the tubular base and attaches along a seam to the outflow end of the tubular base.

18. The heart valve of claim 15, wherein the prosthetic section of the flexible tubular member is pericardial tissue.

19. The heart valve of claim 12, further including a plurality of stitches securing each loop of the flexible tubular member to the corresponding insert.

20. The heart valve of claim 19, further including stitching securing each insert to the corresponding commissure post of the base.