Retaining mechanisms for prosthetic heart valves

• US 10,016,276 B2
• Filed: 11/20/2013
• Issued: 07/10/2018
• Est. Priority Date: 11/21/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Brunnett, William C., Stanislaus, Charles
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US14/441,825
• Publication Number:
  US 20150282931A1
• Time in Patent Office: 1,693 Days
• Field of Search: 606153, 623 111- 154
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

According to one representative embodiment, a method of treating aortic insufficiency comprises delivering a support structure to a position around the leaflets of a native heart valve. The support structure comprises an annular body defining an interior and at least one projection extending radially inwardly from the annular body. An expandable prosthetic heart valve can be advanced into the native heart valve and into the interior of the annular body. The prosthetic heart valve can be expanded into contact with the leaflets of the native valve, thereby causing the leaflets of the native valve to be frictionally secured between an inner surface of the annular body and an outer surface of the prosthetic heart valve and causing the at least one projection and a portion of one of the leaflets contacted by the at least one projection to extend into an opening of the frame of the prosthetic valve.

Claims

1. A method of treating aortic insufficiency, comprising:

delivering a support structure to a position on or adjacent to a surface of the outflow side of a native heart valve of a patient, the support structure comprising an annular metal frame defining an interior and at least one projection comprising a non-metallic material and extending radially inwardly from the metal frame;

positioning the support structure around the leaflets of the native heart valve such that the leaflets of the native heart valve are located within the interior of the metal frame;

advancing an expandable prosthetic heart valve into the native heart valve and into the interior of the metal frame, the prosthetic heart valve comprising a radially expandable annular frame defining a plurality of openings; and

expanding the expandable prosthetic heart valve into contact with the leaflets of the native valve, thereby causing the leaflets of the native valve to be frictionally secured between an inner surface of the metal frame and an outer surface of the prosthetic heart valve and causing the at least one projection and a portion of one of the leaflets contacted by the at least one projection to extend into one of said openings of the frame of the prosthetic heart valve;

wherein the metal frame comprises a plurality of struts and a pair of apertures formed in at least one of the struts, and the at least one projection comprises a wound or knotted ball of suture material disposed radially inwardly relative to the at least one of the struts, and two suture tails extending from opposite sides of the wound or knotted ball, wherein the suture tails are threaded radially outwardly through the pair of apertures and tied to each other at a location radially outwardly relative to the at least one of the struts to secure the at least one projection to the at least one of the struts.

2. The method of claim 1, wherein the metal frame comprises an inflow end and an outflow end, and the at least one projection is located along the length of the metal frame between the inflow and outflow ends.

3. The method of claim 1, wherein the at least one projection comprises a plurality of projections extending radially inwardly from the metal frame, and when the prosthetic heart valve is expanded to contact the leaflets of the native valve, each projection and a portion of one of the leaflets contacted by the projection are caused to extend into one of said openings of the frame.

4. The method of claim 1, wherein the act of advancing the prosthetic valve into the native heart valve is performed after the support structure is positioned around the leaflets of the native heart valve and while the support structure is maintained in a substantially fixed position relative to the native heart valve.

5. An assembly for treating aortic insufficiency, comprising:

a prosthetic heart valve configured to be implanted within a native heart valve, the prosthetic heart valve comprising a radially expandable annular frame defining a plurality of openings; and

a support stent configured to be implanted around native leaflets of the native heart valve such that the native leaflets can be frictionally secured between the support stent and the prosthetic heart valve, the support stent comprising an annular metal frame that defines one or more peaks and one or more valleys along its circumference, the support stent frame being radially compressible into a compressed state and self-expandable into an uncompressed state, the support stent further comprising at least one projection comprising a non-metallic material, the at least one projection extending radially inwardly from the support stent frame and configured to press a portion of one of the native leaflets into one of the openings of the frame of the prosthetic heart valve, wherein the metal frame comprises a plurality of struts and a pair of apertures formed in at least one of the struts, wherein the at least one projection comprises a knotted or wound ball of suture material disposed radially inwardly relative to the at least one of the struts, and two suture tails extending from opposite sides of the knotted or wound ball, wherein the suture tails are threaded radially outwardly through the pair of apertures and tied to each other at a location radially outwardly relative to the at least one of the struts to secure the at least one projection to the at least one of the struts.

6. The assembly of claim 5, wherein the support stent is sized such that it can be positioned within the aorta of a patient at a location adjacent to the aortic valve and thereby circumscribe the native leaflets of the aortic valve.

7. The assembly of claim 5, wherein the support stent further comprises a fabric cover covering the support stent frame and the at least one projection.

8. The assembly of claim 5, wherein the support stent includes an inflow end and an outflow end, and the at least one projection is located along a length of the support stent between the inflow and outflow ends.

9. The assembly of claim 5, wherein the at least one projection comprises a plurality of projections extending radially inwardly from the annular metal frame of the support stent, and wherein the plurality of projections are configured such that, when the prosthetic heart valve is expanded to contact the native leaflets of the native heart valve, each of the plurality of projections and a portion of one of the native leaflets are caused to extend into one of the plurality of openings of the annular frame of the prosthetic heart valve, wherein each projection is secured to one of the struts of the metal frame with two respective suture tails extending outwardly through a pair of apertures in the corresponding strut.

10. The assembly of claim 5, wherein the knotted or wound ball comprises a triple wrap knot formed by a multi-stranded suture knit or braid.

11. The assembly of claim 5, wherein the at least one of the struts comprises a plurality of pairs of apertures and the at least one projection comprises a plurality of knotted or wound balls, each of which is secured to a respective pair of apertures.

12. The assembly of claim 5, wherein the at least one projection comprises a knotted ball of suture material.

13. An assembly for treating aortic insufficiency, comprising:

a prosthetic heart valve configured to be implanted within a native heart valve, the prosthetic heart valve comprising a radially expandable annular frame defining a plurality of openings; and

a support stent configured to be implanted around native leaflets of the native heart valve such that the native leaflets can be frictionally secured between the support stent and the prosthetic heart valve, the support stent comprising an annular metal frame comprising a plurality of struts arranged to define one or more peaks and one or more valleys along a circumference of the frame, the support stent frame being radially compressible into a compressed state and self-expandable into an uncompressed state;

wherein the support stent further comprises a plurality of projections comprising a non-metallic material, the plurality of projections extending radially inwardly from the struts of the metal frame, wherein the plurality of projections are configured such that, when the prosthetic heart valve is expanded to contact the native leaflets of the native heart valve, each of the plurality of projections and a portion of one of the native leaflets are caused to extend into one of the plurality of openings of the annular frame of the prosthetic heart;

wherein each projection comprises a knotted or wound ball of suture material disposed radially inwardly relative to an adjacent strut of the metal frame, and two suture tails extending from opposite sides of the knotted or wound ball and threaded radially outwardly through respective apertures in the adjacent strut, with the suture tails being tied to each other at a location radially outwardly relative to the adjacent strut to secure the knotted or wound ball of suture material to the adjacent strut;

wherein the projections are secured to respective struts at locations between opposing ends of the struts;

wherein the support stent further comprises a fabric cover covering the struts and the projections.

14. The assembly of claim 13, wherein each projection comprises a knotted ball of suture material.