Aortic insufficiency repair device and method

• US 10,507,106 B2
• Filed: 04/07/2017
• Issued: 12/17/2019
• Est. Priority Date: 11/22/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Karapetian, Emil, Stanislaus, Maria Charles Vija, Bak-Boychuk, Gregory, Olson, Christopher J., Hernandez, Cristobal R., Brunnett, William C., Benichou, Netanel, Freschauf, Lauren R., Siegel, Alexander J.
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/482,555
• Publication Number:
  US 20170209265A1
• Time in Patent Office: 984 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 support frame configured to be implanted in a native heart valve, the support frame comprising:

an inflow end and an outflow end;

a radially expandable and collapsible annular main body including a plurality of angled struts and including a plurality of apices formed by the intersection of respective adjacent struts; and

one or more pairs of clipping arms, each of the one or more pairs of clipping arms being located between two of the respective adjacent struts defining an apex of the main body, each of the clipping arms comprising a fixed end portion and a free end portion, the free end portion being offset from the apex in a direction toward the inflow end, the clipping arms defining a leaflet-receiving space between two opposing surfaces of the clipping arms for engaging portions of adjacent native leaflets of the native heart valve therebetween;

wherein the clipping arms are disposed within an outer diameter of the support frame defined by the plurality of angled struts.

2. The support frame of claim 1, wherein the fixed end portion of each clipping arm of the one or more pairs of clipping arms is coupled to one of the respective adjacent struts, and the clipping arms extend in a direction toward the apex at the outflow end of the support frame.

3. The support frame of claim 1, wherein the fixed end portion of each of the clipping arms is coupled to one of the respective adjacent struts and the clipping arms extend in a direction toward the inflow end of the support frame.

4. The support frame of claim 1, wherein each clipping arm of the one or more pairs of clipping arms is curved such that the free end portion of each of the clipping arms is angled away from the other.

5. The support frame of claim 1, wherein the one or more pairs of clipping arms are movable between an open position and a closed position to adjust the leaflet-receiving space.

6. The support frame of claim 1, wherein the one or more pairs of clipping arms are configured to be positioned over one or more commissures formed by the native leaflets of the heart valve.

7. The support frame of claim 1, wherein the support frame comprises three pairs of clipping arms configured to engage commissures of the native heart valve.

8. The support frame of claim 1, wherein the support frame comprises one or more retaining arms coupled to respective of the apices, the one or more retaining arms being configured to engage a delivery device.

9. The support frame of claim 1, wherein the support frame is configured to reduce the orifice area of the heart valve after implantation.

10. The support frame of claim 1, wherein the main body is configured to receive and securely hold a separately deployable prosthetic heart valve when the main body is in a radially expanded state, the prosthetic heart valve including a frame and a leaflet structure situated within the frame.

11. The support frame of claim 1, wherein the free end portions of the clipping arms are located beneath the apex of the frame.

12. A support frame configured to be implanted in a native heart valve, the support frame comprising:

an inflow end and an outflow end;

a radially expandable and collapsible annular main body including a plurality of angled struts and including a plurality of apices formed by the intersection of respective adjacent struts; and

one or more pairs of clipping arms, each of the one or more pairs of clipping arms being located between two of the respective adjacent struts defining an apex of the main body, each of the clipping arms comprising a fixed end portion and a free end portion, the free end portion being offset from the apex in a direction toward the inflow end, the clipping arms defining a leaflet-receiving space between two opposing surfaces of the clipping arms for engaging portions of adjacent native leaflets of the native heart valve therebetween;

wherein the one or more pairs of clipping arms are movable between an open position and a closed position to adjust the leaflet-receiving space; and

wherein when the support frame is partially deployed from a delivery catheter the one or more pairs of clipping arms are in the open position.

13. The support frame of claim 12, configured such that when the support frame is fully deployed from the delivery catheter the one or more pairs of clipping arms move to the closed position.

14. A support frame configured to be implanted in a native heart valve, the support frame comprising:

an inflow end and an outflow end;

a radially expandable and collapsible annular main body including a plurality of angled struts and including a plurality of apices formed by the intersection of respective adjacent struts; and

one or more pairs of clipping arms, each of the one or more pairs of clipping arms being located between two of the respective adjacent struts defining an apex of the main body, each of the clipping arms comprising a fixed end portion and a free end portion, the free end portion being offset from the apex in a direction toward the inflow end, the clipping arms defining a leaflet-receiving space between two opposing surfaces of the clipping arms for engaging portions of adjacent native leaflets of the native heart valve therebetween;

wherein the clipping arms of each pair of clipping arms overlap one another when the support frame is in an expanded configuration.

15. A support frame configured to be implanted in a native heart valve, the support frame comprising:

an inflow end and an outflow end;

a radially expandable and collapsible annular main body including a plurality of angled struts and including a plurality of apices formed by the intersection of respective adjacent struts; and

one or more pairs of clipping arms, each of the one or more pairs of clipping arms being located between two of the respective adjacent struts defining an apex of the main body, each of the clipping arms comprising a fixed end portion and a free end portion, the free end portion being offset from the apex in a direction toward the inflow end, the clipping arms defining a leaflet-receiving space between two opposing surfaces of the clipping arms for engaging portions of adjacent native leaflets of the native heart valve therebetween;

wherein at least one clipping arm of each of the one or more pairs of clipping arms comprises serrations.

16. A support frame configured to be implanted in a native heart valve, the support frame comprising:

an inflow end and an outflow end;

a radially expandable and collapsible annular main body including a plurality of angled struts and including a plurality of apices formed by the intersection of respective adjacent struts; and

one or more pairs of clipping arms, each of the one or more pairs of clipping arms being located between two of the respective adjacent struts defining an apex of the main body, each of the clipping arms comprising a fixed end portion and a free end portion, the free end portion being offset from the apex in a direction toward the inflow end, the clipping arms defining a leaflet-receiving space between two opposing surfaces of the clipping arms for engaging portions of adjacent native leaflets of the native heart valve therebetween;

wherein one clipping arm of each of the one or more pairs 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.

17. An assembly, comprising:

a support frame configured to be implanted in a native heart valve, the support frame comprising;

an inflow end and an outflow end;

a radially expandable and collapsible annular main body including a

plurality of angled struts and including a plurality of apices formed by the intersection of respective adjacent struts; and

one or more pairs of clipping arms, each of the one or more pairs of clipping arms being located between two of the respective adjacent struts defining an apex of the main body, each of the clipping arms comprising a fixed end portion and a free end portion, the free end portions being offset from the apex in a direction toward the inflow end, the clipping arms defining a leaflet-receiving space between two opposing surfaces of the clipping arms for engaging portions of adjacent native leaflets of the native heart valve therebetween, the clipping arms being disposed within an outer diameter of the support frame defined by the plurality of angled struts; and

a prosthetic heart valve including a frame and a leaflet structure, wherein the support frame and the prosthetic heart valve are configured to capture native leaflets of the native heart valve between the support frame and the prosthetic heart valve when the support frame and the prosthetic heart valve are deployed in the native heart valve.

18. The assembly of claim 17, wherein the fixed end portion of each clipping arm is coupled to one of the respective adjacent struts and extends in a direction toward the apex at the outflow end of the support frame.

19. The assembly of claim 17, wherein the fixed end portion of each clipping arm is coupled to one of the respective adjacent struts and the clipping arms extend in a direction toward the inflow end of the support frame.

20. The assembly of claim 17, wherein the support frame comprises three pairs of clipping arms configured to engage commissures of the native heart valve.