RETAINING MECHANISMS FOR PROSTHETIC HEART VALVES

• US 20150282931A1
• Filed: 11/20/2013
• Published: 10/08/2015
• 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, Rabito, Glen T., Karapetian, Emil, Armer, Dustin P., Khuu, Nancy
• Granted Patent: US 10,016,276 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 the surface of the outflow side of a native heart valve of a patient, the support structure comprising an annular body defining an interior and at least one projection extending radially inwardly from the annular body;

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 annular body;

advancing an expandable prosthetic heart valve into the native heart valve and into the interior of the annular body, 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 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 one of said openings of the frame.

2. The method of claim 1, wherein the annular body comprises an inflow end and an outflow end, and the at least one projection is located along the length of the annular body 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 annular body, 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 at least one projection comprises a non-metallic material.

5. The method of claim 1, wherein the at least one projection comprises a knotted or wound ball of elongated material.

6. The method of claim 1, wherein the at least one projection comprises a ball of suture material.

7. 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.

8. An assembly for treating aortic insufficiency, comprising:

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

a support stent configured to be implanted around the leaflets of the native heart valve such that the native leaflets can be frictionally secured between the support stent and the prosthetic 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 valve.

9. The assembly of claim 8, 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.

10. The assembly of claim 8, wherein the at least one projection comprises an elongated material knotted or wound into ball.

11. The assembly of claim 10, wherein the elongated material comprises suture material.

12. The assembly of claim 10, wherein the ball of elongated material is tied onto a portion of the frame of the support stent.

13. The assembly of claim 8, wherein the at least one projection comprises a polymer.

14. The assembly of claim 8, wherein the support stent further comprising a fabric cover covering the support stent frame and the at least one projection.

15. A delivery apparatus for delivering a radially self-expandable prosthetic device to a native heart valve, the apparatus comprising:

a first elongated shaft having a distal end portion;

a second elongated shaft extending over the first shaft;

a plurality of attachment arms extending distally from the distal end portion of the first shaft, each attachment arm having an aperture configured to receive an end portion of a retaining arm of the prosthetic device;

a plurality of release wires extending alongside the attachment arms and configured to extend through corresponding openings in the end portions of the retaining arms when the end portions of the retaining arms are inserted through corresponding openings in the attachment arms so as to releasably secure the prosthetic device to the attachment arms; and

a plurality of sheaths extending distally from the distal end of the first shaft, each sheath extending co-axially over a respective pair of an attachment arm and a release wire so as to maintain the release wire in close proximity to the attachment arm.

16. The delivery apparatus of claim 15, wherein the attachment arms, the release wires, the sheaths, and the prosthetic device are configured to be received in a distal end portion of the second shaft for delivery of the prosthetic device into a patient and the second shaft and the first shaft are movable axially relative to each other to deploy the attachment arms, the release wires, the sheaths, and the prosthetic device from the distal end portion of the second shaft adjacent an implantation location inside the patient.

17. The delivery apparatus of claim 16, wherein the attachment arms, the release wires, the sheaths are configured to bow outwardly relative to each other when the attachment arms, the release wires, the sheaths, and the prosthetic device are deployed from the distal end portion of the second shaft.

18. A delivery apparatus for delivering a radially self-expandable prosthetic device to a native heart valve, the apparatus comprising:

a first elongated shaft having a proximal end portion and a distal end portion, the distal end portion configured to be releasably coupled to the prosthetic device during delivery of the prosthetic device into a patient;

a second elongated shaft having a proximal end portion and a distal end portion, the second shaft extending over the first shaft, the distal end portion of the second shaft comprising a sheath configured to at least partially receive the prosthetic device in a radially compressed state, the second shaft configured to be selectively bendable;

a handle coupled to the proximal end portions of the first and second shafts, the handle having an adjustment mechanism configured to adjust the curvature of the second shaft, wherein the first shaft is allowed to move in a proximal direction relative to the second shaft and the handle when the second shaft foreshortens as a result of the adjustment mechanism being actuated to increase the curvature of the second shaft.

19. The delivery apparatus of claim 18, wherein the proximal end portion of the first shaft extends through a drive mechanism in the handle, the drive mechanism having a distal end portion and a proximal end portion that limit distal movement and proximal movement, respectively, of the first shaft relative to the handle and the second shaft when the curvature of the second shaft is adjusted.

20. The delivery apparatus of claim 19, further comprising an adjustable stop member mounted on the first shaft at a location between the distal and proximal end portions of the drive mechanism, the stop member being positionable at multiple locations along the first shaft so as to adjust the amount of proximal movement of the first shaft relative to the second shaft when the curvature of the second shaft is increased.

21. The delivery apparatus of claim 18, wherein the first shaft comprises a plurality of annular grooves and the stop member comprises a removable clip that is mountable to the first shaft within a selected one of the grooves.

22. The delivery apparatus of claim 18, wherein the handle comprises a rotatable knob operatively connected to the first shaft and configured to effect axial movement of the first shaft relative to the second shaft to deploy the prosthetic device from the sheath of the second shaft, the handle further comprising a spring configured to provide resistance against rotation of the knob, wherein the resistance of the spring is greater against rotation of the knob in a first direction than it is against rotation of the knob in a second direction, opposite the first direction.

23. A delivery apparatus for delivering a radially self-expandable prosthetic device to a native heart valve, the apparatus comprising:

a first elongated shaft having a proximal end portion and a distal end portion, the distal end portion configured to be releasably coupled to the prosthetic device during delivery of the prosthetic device into a patient;

a second elongated shaft having a proximal end portion and a distal end portion, the second shaft extending over the first shaft, the distal end portion of the second shaft comprising a sheath configured to at least partially receive the prosthetic device in a radially compressed state;

a handle coupled to the proximal end portions of the first and second shafts, the handle comprising a rotatable knob operatively connected to the first shaft and configured to effect axial movement of the first shaft relative to the second shaft to deploy the prosthetic device from the sheath of the second shaft, the handle further comprising a spring configured to provide resistance against rotation of the knob.

24. The delivery apparatus of claim 23, wherein the resistance of the spring is greater against rotation of the knob in a first direction than it is against rotation of the knob in a second direction, opposite the first direction.