Minimally-invasive heart valve with cusp positioners

• US 7,399,315 B2
• Filed: 03/18/2003
• Issued: 07/15/2008
• Est. Priority Date: 03/18/2003
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Iobbi, Mario M.
• Primary Examiner(s): Prebilic; Paul B
• Application Number:
  US10/390,951
• Publication Number:
  US 20040186563A1
• Time in Patent Office: 1,946 Days
• Field of Search: 623/2.14, 623/2.17, 623/2.18, 623/2.19, 623/1.24, 623/1.25, 623/1.26
• US Class Current: 623/1.26
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures. In the aortic valve position, the cusp positioners angle outward into contact with the sinus cavities, and compress the native leaflets if they are not excised, or the aortic wall if they are. The support frame may be formed from a flat sheet of Nitinol that is bent into a three-dimensional configuration and heat set. A holder having spring-like arms connected to inflow projections of the valve may be used to deliver, reposition and re-collapse the valve, if necessary.

Claims

1. A collapsible prosthetic heart valve, comprising:

a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the outflow end of the leaflet frame and circumferentially about the flow axis;

three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions; and

three cusp positioners integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve;

wherein each cusp positioner has a U-shape with an apex of the U-shape pointing toward the outflow end of the leaflet frame and two legs of the U-shape pointing toward the inflow end.

2. The heart valve of claim 1, wherein each of the two legs of each U-shaped cusp positioner is rigidly fixed to the collapsible leaflet frame at a location approximately midway between a cusp legion and a commissure region thereof.

3. The heart valve of claim 1, further including an anti-migration member rigidly fixed to each cusp positioner and projecting therefrom.

4. A collapsible prosthetic heart valve, comprising:

a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the outflow end of the leaflet frame and circumferentially about the flow axis;

three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions; and

three cusp positioners integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve;

wherein the heart valve further includes three cusp connectors rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp connector being located at the inflow end of the leaflet frame and intermediate two of the cusp regions of the leaflet frame;

wherein each cusp connector has a U-shape with an apex of the U-shape pointing toward the inflow end of the leaflet frame and two legs of the U-shape pointing toward the outflow end.

5. The heart valve of claim 4, wherein the leaflet frame, cusp positioners, and cusp connectors are formed integrally as a single piece, and wherein the three cusp positioners and three cusp connectors define a continuous, undulating shape that generally mimics the shape of the leaflet frame but is rotated 60°

about the flow axis therefrom.

6. A collapsible prosthetic heart valve, comprising:

a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the outflow end of the leaflet frame and circumferentially about the flow axis;

three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions; and

three cusp positioners integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve;

wherein the leaflet frame has a fabric covering along substantially its entire length, the fabric covering defining a flange, wherein the arcuate cusp edges of the flexible leaflets attach to the fabric covering flange;

wherein the fabric covering flange projects generally outwardly from the leaflet frame, and the cusp edges of the flexible leaflets extend radially outwardly past and underneath the leaflet frame, and are sewn to the fabric covering flange.

7. A collapsible prosthetic heart valve, comprising:

a collapsible leaflet frame having an inflow end and an outflow end and three cusp regions intermediate three commissure regions, the three cusp regions being positioned at the inflow end of the leaflet frame and circumferentially about a flow axis defined within the support frame, the three commissure regions being positioned at the outflow end of the leaflet frame and circumferentially about the flow axis;

three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the commissure regions; and

three cusp positioners integrally attached to the leaflet frame and disposed circumferentially about the flow axis, at least a portion of each cusp positioner being located adjacent to a flexible leaflet and axially positioned between the free edge and cusp edge of the flexible leaflet, the three cusp positioners extending radially farther outwardly than the three commissure regions and configured for engagement with native leaflets of a heart valve;

wherein each flexible leaflet has a pair of tabs extending on either side of its free edge, wherein two tabs of adjacent flexible leaflets meet and pass together to the outside of the adjacent commissure region of the leaflet frame and are attached thereto using sutures through the tabs.

8. A collapsible prosthetic heart valve, comprising:

a continuous, collapsible leaflet frame shaped for implantation within a defective native heart valve, the frame having a periphery defined by only three U-shaped cusp regions intermediate three U-shaped commissure regions, the three U-shaped cusp regions being positioned at an inflow end of the leaflet frame and circumferentially about a flow axis defined within the leaflet frame, the three U-shaped cusp regions defining at least a portion of a terminal end of the leaflet frame, the three U-shaped commissure regions being positioned at an outflow end of the leaflet frame and circumferentially about the flow axis;

a cloth covering extending around the leaflet frame; and

three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the U-shaped cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the U-shaped commissure regions, the commissure edges of each leaflet further including a tab, wherein the tabs of two adjacent leaflets extend through the U-shaped commissure region, diverge on the outside of U-shaped commissure region, and are attached to the leaflet frame on the outside of the U-shaped commissure region.

10. The heart valve of claim 8, wherein the heart valve further includes three cusp connectors rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp connector being located at the inflow end of the leaflet frame and intermediate two of the cusp regions of the leaflet frame.

11. The heart valve of claim 10, wherein an inflow periphery of the heart valve is defined along the alternating and rigidly fixed cusp regions and cusp connectors.

12. The heart valve of claim 8, wherein the leaflet frame has a fabric covering along substantially its entire length, the fabric covering defining a flange, wherein the arcuate cusp edges of the flexible leaflets attach to the fabric covering flange.

13. The heart valve of claim 12, wherein the fabric covering flange projects generally outward from the leaflet frame, and the cusp edges of the flexible leaflets extend radially outward past and underneath the leaflet frame, and are sewn to the fabric covering flange.

9. A collapsible prosthetic heart valve, comprising:

a continuous, collapsible leaflet frame having a periphery defined by only three U-shaped cusp regions intermediate three U-shaped commissure regions, the three U-shaped cusp regions being positioned at an inflow end of the leaflet frame and circumferentially about a flow axis defined within the leaflet frame, the three U-shaped cusp regions defining at least a portion of a terminal end of the leaflet frame, the three U-shaped commissure regions being positioned at an outflow end of the leaflet frame and circumferentially about the flow axis;

a cloth covering extending around the leaflet frame;

three separate, flexible leaflets attached to the leaflet frame, each leaflet having an arcuate cusp edge opposite a free edge and a pair of commissure edges therebetween, the leaflets being attached around the leaflet frame with the cusp edge of each leaflet extending along one of the U-shaped cusp regions, and a commissure edge of each leaflet meeting a commissure edge of an adjacent leaflet at one of the U-shaped commissure regions, the commissure edges of each leaflet further including a tab, wherein the tabs of two adjacent leaflets extend through the U-shaped commissure region, diverge on the outside of U-shaped commissure region, and are attached to the leaflet frame on the outside of the U-shaped commissure region; and

three cusp positioners rigidly fixed with respect to the leaflet frame and disposed circumferentially about the flow axis, each cusp positioner being located at the outflow end of the support frame and intermediate two of the commissure regions of the leaflet frame, each cusp positioner having a U-shape with an apex of the U-shape pointing toward the outflow end of the leaflet frame and two legs of the U-shape pointing toward the inflow end.