Rapid deployment methods for prosthetic heart valves

• US 9,901,448 B2
• Filed: 04/13/2015
• Issued: 02/27/2018
• Est. Priority Date: 06/26/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pintor, Rafael, Chau, Mark, Oba, Travis, Yambao, August R., Campbell, Louis A., Huntley, Tammy, Zeng, Qinggang, Cristea, Carey L., Kalam, Faisal
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US14/685,489
• Publication Number:
  US 20150216660A1
• Time in Patent Office: 1,051 Days
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

A quick-connect heart valve prosthesis that can be quickly and easily implanted is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps.

Claims

1. A surgical method for delivering and implanting a prosthetic heart valve to an aortic annulus, the method comprising:

creating an access path to an operating site at the aortic annulus of the patient;

attaching three guide sutures at three spaced locations around the aortic annulus and extending three pairs of free ends of the guide sutures out of the operating site;

preparing for implant a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice and surrounded on an inflow end by a sealing ring, the heart valve further including a plastically-expandable coupling stent connected to and extending from an inflow end of the prosthetic valve, the coupling stent having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the aortic annulus, the coupling stent being connected to the prosthetic valve during the manufacturing process in a manner that forms the coupling stent and prosthetic valve into a unitary heart valve capable of being implanted together;

threading the three pairs of free ends of the guide sutures through spaced locations around the sealing ring;

advancing the heart valve along the guide sutures with the coupling stent in its contracted state to an implant position at the aortic annulus with the sealing ring positioned supra-annularly and the coupling stent in its contracted state extending into the aortic annulus; and

applying outward force on the inside of the coupling stent to convert the coupling stent from the contracted state to the expanded state into contact with the aortic annulus.

2. The method of claim 1, wherein the heart valve is mounted on a valve holder having a proximal hub and lumen therethrough, the method including mounting the holder on a distal end of a handle having a lumen therethrough, passing a balloon of a balloon catheter through the lumen of the handle and the holder to a position within the coupling stent, and inflating the balloon to apply outward force on the coupling stent.

3. The method of claim 2, wherein the contracted state of the coupling stent is conical, and wherein the balloon on the balloon catheter has a larger distal expanded end than its proximal expanded end so as to apply greater expansion deflection to the distal end of the coupling stent than to its proximal end that is connected to the inflow end of the prosthetic valve.

4. The method of claim 1, including increasing the orifice size of the heart valve annulus by 1.0-5 mm by plastically expanding the coupling stent.

5. The method of claim 4, wherein the prosthetic valve of the heart valve is selected to have an orifice size that matches the increased orifice size of the heart valve annulus.

6. The method of claim 1, wherein the guide sutures are attached to locations below or corresponding to the coronary ostia.

7. The method of claim 1, wherein the prosthetic valve includes a support structure with an undulating shape of alternative commissures and cusps in an outflow direction that supports flexible leaflets, and the guide sutures thread through the sealing ring mid-way between the valve commissures at the cusps.

8. The method of claim 7, wherein the sealing ring has an undulating inflow side with regions aligned with the valve cusps that are axially thicker than regions aligned with the valve commissures to provide more material for securing the guide sutures.

9. The method of claim 1, further including passing each of the three guide sutures through a respective one of a plurality of tubular suture snares and applying downward pressure on the sealing ring with the plurality of tubular suture snares to help seat the ring on the aortic annulus.

10. The method of claim 9, wherein the plurality of tubular suture snares are bendable, and the method further includes bending the plurality of tubular suture snares outward to improve access to the heart valve and implant site.

11. The method of claim 1, further including securing the guide sutures on a proximal side of the sealing ring using fastener clips.

12. A surgical method for delivering and implanting a prosthetic heart valve to an aortic annulus, the method comprising:

creating an access path to an operating site at the aortic annulus of the patient;

attaching three guide sutures at three spaced locations around the aortic annulus and extending three pairs of free ends of the guide sutures out of the operating site;

preparing for implant a heart valve including a prosthetic valve and a plastically-expandable coupling stent connected to and extending from an inflow end of the prosthetic valve, the coupling stent having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the aortic annulus, the coupling stent being connected to the prosthetic valve during the manufacturing process in a manner that forms the coupling stent and prosthetic valve into a unitary heart valve capable of being implanted together;

threading the three pairs of free ends of the guide sutures through spaced locations around the inflow end of the prosthetic valve;

advancing the heart valve along the guide sutures to an implant position at the aortic annulus with the coupling stent in its contracted state extending into the aortic annulus; and

applying outward force on the inside of the coupling stent to convert the coupling stent from the contracted state to the expanded state into contact with the aortic annulus.

13. The method of claim 12, wherein the step of applying outward force on the inside of the coupling stent includes positioning a balloon of a balloon catheter to a position within the coupling stent, and inflating the balloon to apply outward force on the coupling stent.

14. The method of claim 12, wherein the three spaced locations around the aortic annulus correspond to the aortic sinuses.

15. The method of claim 12, wherein the prosthetic valve further includes a sealing ring surrounding the inflow end thereof, and the three pairs of free ends of the guide sutures are threaded through the sealing ring.

16. The method of claim 15, further including securing the three pairs of free ends of the guide sutures on a proximal side of the sealing ring using fastener clips.

17. The method of claim 15, further including passing each of the three guide sutures through a respective one of a plurality of tubular suture snares and applying downward pressure on the sealing ring with the plurality of tubular suture snares to help seat the ring on the aortic annulus.

18. The method of claim 17, wherein the plurality of tubular suture snares are bendable, and the method further includes bending the plurality of tubular suture snares outward to improve access to the heart valve and implant site.

19. The method of claim 12, wherein the prosthetic valve has a non-expandable, non-collapsible orifice, and the step of applying outward force on the inside of the coupling stent includes passing a balloon of a balloon catheter through the prosthetic valve to a position within the coupling stent, and inflating the balloon to apply outward force on the coupling stent.

20. The method of claim 19, wherein the heart valve is mounted on a valve holder having a proximal hub and lumen therethrough, the method including mounting the holder on a distal end of a handle having a lumen therethrough, passing the balloon catheter through the lumen of the handle and the holder to the position within the coupling stent, and inflating the balloon to apply outward force on the coupling stent.