Methods for quickly implanting a prosthetic heart valve

• US 10,182,909 B2
• Filed: 02/02/2017
• Issued: 01/22/2019
• Est. Priority Date: 12/19/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pintor, Rafael, Chau, Mark, Oba, Travis Zenyo, Yambao, August R., Campbell, Louis A., Huntley, Tammy, Zeng, Qinggang, Cristea, Carey L., Kalam, Faisal
• Primary Examiner(s): Snow, Bruce E
• Application Number:
  US15/423,378
• Publication Number:
  US 20170296336A1
• Time in Patent Office: 719 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Claims

1. A method of delivery and implant of a prosthetic heart valve to an aortic annulus, comprising:

establishing a patient on cardiopulmonary bypass;

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

preparing for implant a heart valve including a non-expandable, non-collapsible prosthetic valve having an orifice and surrounded on an inflow end by a sealing ring having an undulating contour on an underside thereof to match the undulating contour of the aortic annulus, the heart valve further including an expandable cloth-covered coupling stent connected to the prosthetic valve and extending away in the inflow direction therefrom, the coupling stent having a conical contracted state for delivery to an implant position and a conical expanded state configured for outward connection to the aortic annulus, the coupling stent further having a reinforcing ring on an outflow end 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 substantially solid cloth-covered conical skirt extending from the sealing ring to help seal against paravalvular leakage and promote tissue ingrowth;

connecting a delivery handle to the heart valve;

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

expanding the coupling stent within the left ventricle.

2. The method of claim 1, wherein the heart valve is mounted on a valve holder having a proximal hub and lumen therethrough, and the step of connecting includes mounting the valve holder on the distal end of the delivery handle which also has a lumen therethrough, the method including 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 aortic 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 step of connecting the delivery handle to the heart valve is done with a snap-fit coupling between the delivery handle and a valve holder to which the heart valve mounts.

7. The method of claim 1, wherein the coupling stent reinforcing ring is continuously sewn to the prosthetic valve.

8. The method of claim 1, wherein the coupling stent is formed of a plastically expandable material, and the step of expanding the coupling stent includes forcibly outwardly expansion thereof.

9. The method of claim 1, further including a step of delivering and expanding a base stent at the aortic annulus prior to the steps of advancing and expanding the heart valve.

10. The method of claim 1, wherein the coupling stent is formed of a self-expandable material, and the step of expanding the coupling stent includes permitting it to expand into contact with the base stent.

11. A method of delivery and implant of a prosthetic heart valve to an aortic annulus, comprising:

establishing a patient on cardiopulmonary bypass;

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

preparing for implant a heart valve including a non-expandable, non-collapsible prosthetic valve having an orifice, the heart valve further including an expandable cloth-covered coupling stent continuously sewn to the prosthetic valve and extending away in the inflow direction therefrom, 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 thus providing when expanded a substantially solid cloth-covered skirt extending from the prosthetic valve into the left ventricle to help seal against paravalvular leakage and promote tissue ingrowth;

connecting a delivery handle to the heart valve;

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

expanding the coupling stent within the left ventricle.

12. The method of claim 11, wherein the heart valve is mounted on a valve holder having a proximal hub and lumen therethrough, and the step of connecting includes mounting the valve holder on the distal end of the delivery handle which also has a lumen therethrough, the method including 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.

13. The method of claim 12, 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 a proximal expanded end so as to apply greater expansion deflection to a distal end of the coupling stent than to an end that is connected to the prosthetic valve.

14. The method of claim 11, including increasing the orifice size of the aortic annulus by 1.0-5 mm by plastically expanding the coupling stent.

15. The method of claim 14, 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.

16. The method of claim 11, wherein the step of connecting the delivery handle to the heart valve is done with a snap-fit coupling between the delivery handle and a valve holder to which the heart valve mounts.

17. The method of claim 11, wherein the prosthetic valve of the heart valve is surrounded on an inflow end by a sealing ring having an undulating contour on an underside thereof to match the undulating contour of the aortic annulus.

18. The method of claim 11, wherein the coupling stent is formed of a plastically expandable material, and the step of expanding the coupling stent includes forcibly outwardly expansion thereof.

19. The method of claim 11, further including a step of delivering and expanding a base stent at the aortic annulus prior to the steps of advancing and expanding the heart valve, and the step of advancing the heart valve advances the heart valve within the base stent.

20. The method of claim 11, wherein the coupling stent is formed of a self-expandable material, and the step of expanding the coupling stent includes permitting it to expand into contact with the base stent.

21. A method of delivery and implant of a prosthetic heart valve to an aortic annulus, comprising:

establishing a patient on cardiopulmonary bypass;

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

preparing for implant a heart valve including a non-expandable, non-collapsible prosthetic valve having an orifice, the heart valve further including an expandable cloth-covered coupling stent connected to the prosthetic valve and extending away in the inflow direction therefrom, 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 thus providing when expanded a substantially solid cloth-covered skirt extending from the prosthetic valve into the left ventricle to help seal against paravalvular leakage and promote tissue ingrowth;

connecting a delivery handle to the heart valve;

wherein the heart valve is mounted on a valve holder having a proximal hub and lumen therethrough, and the step of connecting includes mounting the valve holder on the distal end of the delivery handle which also has a lumen therethrough;

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

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; and

expanding the coupling stent within the left ventricle.

22. The method of claim 21, 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 a distal end of the coupling stent than to an end that is connected to the prosthetic valve.