Unitary quick-connect prosthetic heart valve deployment methods

• US 8,696,742 B2
• Filed: 10/10/2012
• Issued: 04/15/2014
• 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): Tyson, Melanie
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/648,906
• Publication Number:
  US 20130090725A1
• Time in Patent Office: 552 Days
• Field of Search: None
• US Class Current: 623/2.11
• 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 method of delivery and implant of a prosthetic heart valve to an aortic annulus, comprising:

preparing for implant a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice and flexible occluding leaflets, the heart valve further including an expandable coupling stent connected to and extending from an inflow end thereof, 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, wherein a valve holder is mounted to the heart valve, the step of preparing including assembling to the valve holder a sleeve that extends between and parts the flexible leaflets, the sleeve having a throughbore;

connecting a delivery handle having a lumen to the valve holder and sleeve assembly such that the lumen aligns with the sleeve throughbore;

advancing the heart valve with the coupling stent in its contracted state to an implant position adjacent the aortic annulus;

advancing a balloon of a balloon catheter through the lumen of the handle and through the sleeve throughbore to a position within the coupling stent; and

inflating the balloon to expand the coupling stent into contact with the aortic annulus.

2. The method of claim 1, wherein the heart valve mounted on the valve holder is packaged separately from the sleeve.

3. The method of claim 1, 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 valve component 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 step of connecting the delivery handle to the valve holder and sleeve assembly is done with a snap-fit coupling.

7. The method of claim 1, wherein the prosthetic valve includes a sealing ring on the inflow end thereof, and the coupling stent is continuously sewn to the sealing ring.

8. The method of claim 1, wherein the prosthetic valve has a sealing ring on an inflow end thereof, the method further including:

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;

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

wherein the step of advancing the heart valve includes advancing the heart valve along the guide sutures.

9. The method of claim 8, wherein the valve holder has a proximal hub and lumen therethrough to which the sleeve couples, wherein the step of advancing the balloon includes passing the balloon through the lumen of the handle and the sleeve coupled to the holder.

10. The method of claim 8, wherein the guide sutures are attached to locations below or corresponding to the coronary ostia.

11. The method of claim 8, wherein the prosthetic valve includes a support structure with an undulating shape of alternative commissures and cusps in an outflow direction that supports the flexible leaflets, and the guide sutures thread through the sealing ring mid-way between the valve commissures at the cusps.

12. The method of claim 11, 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.

13. The method of claim 8, further including passing each of the guide sutures through a tubular suture snare and applying downward pressure on the sealing ring with the snares to help seat the ring on the aortic annulus.

14. The method of claim 13, wherein the suture snares are bendable, and the method further includes bending the sutures snares outward to improve access to the heart valve and implant site.

15. The method of claim 8, further including securing the guide sutures on a proximal side of the sealing ring using fastener clips.

16. The method of claim 1, wherein the prosthetic valve has a sealing ring on an inflow end thereof having an undulating contour on an underside to match the undulating contour of the aortic annulus, wherein the coupling stent is cloth-covered and sewn to the sealing ring, wherein both the contracted state and the expanded state of the coupling stent are both conical, and the coupling stent further having a reinforcing ring on an outflow end continuously sewn to the sealing ring that follows an undulating path with peaks and troughs corresponding to the underside of the sealing ring, the coupling stent thus providing when expanded a solid cloth-covered conical skirt extending from the sealing ring to help seal against paravalvular leakage and promote tissue ingrowth.

17. The method of claim 1, wherein assembling the sleeve to the valve holder comprises passing the sleeve from the inflow direction of the heart valve through the leaflets and coupling the sleeve to the valve holder beyond an outflow end of the heart valve.

18. The method of claim 1, wherein the valve holder has a proximal hub, and the step of connecting includes mounting the hub of the valve holder on the distal end of the delivery handle.

19. The method of claim 1, wherein the prosthetic valve includes a sealing ring on the inflow end thereof, and wherein the coupling stent is continuously sutured around the sealing ring of the prosthetic valve during the manufacturing process in a manner that forms the coupling stent and prosthetic valve into a unitary heart valve.