Minimally-invasive heart valves

• US 8,349,000 B2
• Filed: 04/26/2010
• Issued: 01/08/2013
• 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): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US12/767,278
• Publication Number:
  US 20100211165A1
• Time in Patent Office: 988 Days
• Field of Search: 623/1.24, 623/1.26, 623 212- 219, 623/900
• 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 prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve. In one variation, flanges may be provided on the support stent for improving attachment of the support stent to the host tissue.

Claims

1. A prosthetic heart valve for delivery into a heart without requiring open heart surgery, comprising:

a collapsible, self-expanding support stent comprising a shape memory material, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the three commissure posts being cantilevered from the base, each commissure post having a slot formed therein; and

a flexible tubular member attached to the support stent, the flexible tubular member comprising a fabric section connected to the base along the inflow end of the support stent and a leaflet section defining three leaflets connected to the commissure posts along the outflow end of the support stent, wherein portions of the leaflet section extend outward through the slots in the commissure posts for securing the leaflet section to the commissure posts;

wherein the prosthetic heart valve is compressible to a size suitable for delivery into the heart within a catheter and wherein the base of the support stent is expandable to engage the prosthetic heart valve to an annulus of a native aortic valve and wherein the commissure posts of the support stent support the three leaflets downstream of the base, and

wherein the leaflet section forms loops that pass through each of the commissure posts slots and the prosthetic heart valve further includes inserts disposed within the loops on an outside region of each commissure post, the inserts each having a greater width than the circumferential width of the slots to prevent the loops from pulling inward through the slots.

2. The prosthetic heart valve of claim 1, further including stitches securing the leaflet section loops to the inserts.

3. The prosthetic heart valve of claim 2, further including stitching attaching each insert to a respective commissure post.

4. The prosthetic heart valve of claim 1, wherein the support stent further comprises flanges for improved attachment to host tissue.

5. The prosthetic heart valve of claim 1, wherein the leaflet section is made of bovine pericardial tissue.

6. The prosthetic heart valve of claim 1, wherein the fabric section is attached to the base by sutures.

7. The prosthetic heart valve of claim 1, wherein the fabric section is attached to the leaflet section by sutures along a seam.

8. The prosthetic heart valve of claim 1, wherein the seam is located substantially along an outflow portion of the base.

9. The prosthetic heart valve of claim 1, wherein the fabric section surrounds the base.

10. The prosthetic heart valve of claim 1, wherein the fabric section is made from a polyester material.

11. The prosthetic heart valve of claim 1, wherein the stent further comprises an attachment mechanism configured for securing the valve within the annulus.

12. The prosthetic heart valve of claim 11, wherein the attachment mechanism comprises barbs.

13. The prosthetic heart valve of claim 1, wherein the fabric section comprises polyethylene terephthalate.

14. A prosthetic heart valve for delivery into a heart without requiring open heart surgery, comprising:

a collapsible, self-expanding support stent comprising a shape memory material, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the commissure posts being spaced in 120 degree intervals with gaps therebetween, the tubular base comprising a mesh or web, the support stent further comprising at least one attachment member for improved attachment to host tissue;

a fabric section connected to the base along the inflow end of the support stent, the fabric section made from a polyester material; and

a leaflet section directly attached to the fabric section at a seam, the leaflet section defining three leaflets formed of bovine pericardium, the three leaflets attached to the commissure posts for opening and closing;

wherein the prosthetic heart valve is compressible to a size suitable for delivery into the heart within a catheter and wherein the base of the support stent is expandable to engage the prosthetic heart valve to an annulus of a native aortic valve and wherein the commissure posts of the support stent are configured to maintain the three leaflets at a location downstream of the annulus of the native aortic valve,

wherein each commissure post has a slot formed therein and wherein portions of the leaflet section pass through the slot in each of the commissure posts for securement to the outside thereof, and

wherein the portions of the leaflet section form loops and wherein inserts are disposed within the loops on the outside of each commissure post, the inserts each having a greater width than a circumferential width of the slots to prevent the loops from pulling inward through the slots.