Aortic insufficiency repair device and method

• US 9,622,863 B2
• Filed: 11/20/2014
• Issued: 04/18/2017
• Est. Priority Date: 11/22/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Karapetian, Emil, Stanislaus, Charles, Bak-Boychuk, Gregory, Olson, Christopher, Hernandez, Cristobal, Brunnett, William, Benichou, Netanel, Freschauf, Lauren, Siegel, Alex
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/549,431
• Publication Number:
  US 20150148896A1
• Time in Patent Office: 880 Days
• Field of Search: 623 111, 623 21, 623 211
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts

Abstract

This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises an annular main body formed by a plurality of angled struts, the main body including a plurality of peaks formed by the intersection of respective adjacent struts. The support frame further comprises one or more leaflet-engaging mechanisms configured to engage leaflets of the heart valve. The support frame can be radially expandable and collapsible.

Claims

1. A method of treating valvular insufficiency, comprising:

inserting a delivery catheter into the vasculature of a heart proximate a heart valve, the delivery catheter carrying a support frame in a radially collapsed state, the support frame including a plurality of angled struts and having an inflow end and an outflow end;

positioning the delivery catheter such that one or more leaflet-engaging mechanisms of the support frame are aligned with commissures of the heart valve, each of the one or more leaflet-engaging mechanisms including a pair of clipping arms located between respective struts defining an apex, the clipping arms comprising respective fixed end portions and free end portions, the free end portions being offset from the apex in a direction toward the inflow end of the support frame, the clipping arms defining a leaflet-receiving space between two opposing surfaces of the clipping arms, wherein the leaflet-receiving space is adjustable;

at least partially deploying the support frame from the delivery catheter to allow the support frame to radially expand to at least a partially deployed state; and

engaging a respective pair of native valve leaflets at one or more of the commissures of the heart valve with the clipping arms by locating the support frame such that a respective pair of native valve leaflets is between each pair of clipping arms.

2. The method of claim 1, wherein the act of at least partially deploying the support frame causes the one or more leaflet-engaging mechanisms to move to an open position to increase the leaflet-receiving space.

3. The method of claim 2, further comprising fully deploying the support frame from the delivery catheter such that the one or more leaflet-engaging mechanisms move from the open position to a closed position.

4. The method of claim 1, wherein engaging one or more of the commissures of the heart valve with the one or more leaflet-engaging mechanisms is effective to reduce the orifice area of the heart valve, the orifice area being defined by the native valve leaflets.

5. The method of claim 1, further comprising releasing the support frame from the delivery catheter and allowing the native valve leaflets to regulate the flow of blood through the heart valve.

6. The method of claim 5, further comprising, after releasing the support frame from the delivery catheter and allowing the native valve leaflets to regulate the flow of blood through the heart valve, deploying a prosthetic heart valve within the native valve leaflets such that the native valve leaflets are captured between the support frame and the prosthetic heart valve, the prosthetic heart valve including a frame and a leaflet structure situated within the frame.

7. The method of claim 1, wherein the act of engaging comprises actuating one or more leaflet-engaging mechanisms from an open position to a closed position such that the leaflet-engaging mechanisms engage the commissures of the heart valve.

8. The method of claim 1, wherein the fixed end portions of the clipping arms are coupled to respective struts and the clipping arms extend in a direction toward the outflow end of the support frame.

9. The method of claim 1, wherein the fixed end portions of the clipping arms are coupled to respective struts and the clipping arms extend in a direction toward the inflow end of the frame.

10. The method of claim 1, wherein the clipping arms are curved such that the free end portions are angled away from one another.

11. The method of claim 1, wherein a respective pair of native valve leaflets is clamped between each pair of clipping arms.

12. The method of claim 1, wherein the support frame comprise three pairs of clipping arms configured to engage the commissures of the aortic valve.

13. The method of claim 1, wherein the support frame further comprises one or more retaining arms coupled to one or more of the peaks, the one or more retaining arms being configured to engage a delivery device.

14. The method of claim 1, wherein engaging a respective pair of native valve leaflets further comprises clamping a respective pair of native valve leaflets with the free ends of the clipping arms.

15. The method of claim 1, wherein the clipping arms of each pair of clipping arms overlap one another when the support frame is in an expanded configuration.

16. The method of claim 1, wherein at least one clipping arm of each respective pair of clipping arms comprises serrations.

17. The method of claim 1, wherein one clipping arm of each respective pair of clipping arms comprises a plurality of protrusions, and the other clipping arm comprises a plurality of corresponding recessed portions configured to receive the protrusions when the support frame is in an expanded configuration.