QUICK-CONNECT PROSTHETIC HEART VALVE AND METHODS

• US 20100161036A1
• Filed: 12/10/2009
• Published: 06/24/2010
• Est. Priority Date: 12/19/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Zeng, Qinggeng, Chau, Mark, Pintor, Rafael, Oba, Travis, Yambao, August, Huntley, Tammy, Kalam, Faisal, Cristea, Carey, Campbell, Louis
• Granted Patent: US 8,308,798 B2
• Time in Patent Office: Days
• US Class Current: 623/1.260
• 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 prosthetic heart valve system, comprising:

a base stent adapted to anchor against a heart valve annulus and defining an orifice therein; and

a valve component including a prosthetic valve defining therein a non-expandable, non-collapsible orifice, the valve component further including an expandable coupling stent 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 base stent.

2. The system of claim 1, wherein the base stent is expandable and has a contracted state for delivery to an implant position adjacent a heart valve annulus and an expanded state sized to contact and anchor against the heart valve annulus.

3. The system of claim 2, wherein the base stent is plastically expandable.

4. The system of claim 1, wherein the coupling stent is plastically expandable.

5. The system of claim 1, wherein the prosthetic valve comprises a commercially available valve having a sewing ring, and wherein the coupling stent attaches to the sewing ring.

6. The system of claim 1, wherein the contracted state of the coupling stent is conical, tapering down in a distal direction.

7. The system of claim 6, wherein the coupling stent comprises a plurality of radially expandable struts at least some of which are arranged in rows, and wherein the distalmost row has the greatest capacity for expansion from the contracted state to the expanded state.

8. The system of claim 1, wherein the coupling stent comprises a plurality of radially expandable struts, and a row farthest from the prosthetic valve has alternating peaks and valleys, and wherein the base stent includes apertures into which the peaks of the coupling stent may project to interlock the two stents.

9. The system of claim 1, wherein the base stent includes a plurality of radially expandable struts between axially-oriented struts, and at least some of the axially-oriented struts have upper projections that demark locations around the stent.

10. A method of delivery and implant of a prosthetic heart valve system, comprising:

advancing a base stent to an implant position adjacent a heart valve annulus;

anchoring the base stent to the heart valve annulus;

providing a valve component including a prosthetic valve having a non-expandable, non-collapsible orifice, the valve component further including an expandable coupling stent 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 base stent;

advancing the valve component with the coupling stent in its contracted state to an implant position adjacent the base stent; and

expanding the coupling stent to the expanded state in contact with and connected to the base stent.

11. The method of claim 10, wherein the base stent is plastically expandable, and further comprising:

advancing the expandable base stent in a contracted state to the implant position; and

plastically expanding the base stent to an expanded state in contact with and anchored to the heart valve annulus, in the process increasing the orifice size of the heart valve annulus by at least 10%.

12. The method of claim 11, 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.

13. The method of claim 11, further including mounting the base stent over a mechanical expander, and deploying the base stent at the heart valve annulus using the mechanical expander.

14. The method of claim 10, further including mounting the valve component on a holder having a proximal hub and lumen therethrough, and mounting the holder on the distal end of a handle having a lumen therethrough, the method including passing a balloon catheter through the lumen of the handle and the holder and within the valve component, and inflating a balloon on the balloon catheter to expand the coupling stent.

15. The method of claim 14, further including packaging the valve component mounted on the holder separately from the handle and the balloon catheter.

16. The method of claim 14, 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 coupling stent than to the prosthetic valve.

17. The method of claim 10, wherein the contracted state of the coupling stent is conical, and wherein the coupling stent comprises a plurality of radially expandable struts at least some of which are arranged in rows, and wherein the row farthest from the prosthetic valve has the greatest capacity for expansion from the contracted state to the expanded state.

18. The method of claim 10, wherein the coupling stent comprises a plurality of radially expandable struts, and a row farthest from the prosthetic valve has alternating peaks and valleys, and the method includes expanding the distal end of the coupling stent more than the rest of the coupling stent so that the peaks in the row farthest from the prosthetic valve project outward into apertures in the base stent.

19. The method of claim 10, wherein both the base stent and the coupling stent have a plurality of radially expandable struts between axially-oriented struts, and wherein the method includes orienting the coupling stent so that its axially-oriented struts are out of phase with those of the base stent to increase retention therebetween.

20. The method of claim 10, including increasing the orifice size of the heart valve annulus by 1.5-5 mm by plastically expanding the base stent.

21. A system for delivering a prosthetic heart valve, comprising:

a valve component including a prosthetic valve having a non-expandable, non-collapsible orifice, the valve component further including an expandable coupling stent extending from an inflow end thereof, the coupling stent having a contracted state for delivery to an implant position and an expanded state;

a valve holder connected to a proximal end of the valve component;

a balloon catheter having a balloon; and

a handle configured to attach to a proximal end of the valve holder and having a lumen for passage of the catheter, the balloon extending distally through the handle, past the holder and through the valve component.

22. The system of claim 21, wherein the prosthetic valve comprises a commercially available valve having a sewing ring, and wherein the coupling stent attaches to the sewing ring.

23. The system of claim 21, wherein the contracted state of the coupling stent is conical, tapering down in a distal direction.

24. The system of claim 21, wherein the contracted state of the coupling stent is conical and tapers down in a distal direction, and wherein the balloon catheter further includes a generally conical nose cone on a distal end thereof that extends through the valve component and engages a distal end of the coupling stent in its contracted state.

25. The system of claim 21, wherein the handle comprises a proximal section and a distal section that may be coupled together in series to form a continuous lumen, and wherein the distal section is adapted to couple to the hub of the holder to enable manual manipulation of the valve component using the distal section prior to connection with the proximal handle section.

26. The system of claim 25, wherein the balloon catheter and proximal handle section are packaged together with the balloon within the proximal section lumen.

27. The system of claim 21, wherein the valve component mounted on the holder is packaged separately from the handle and the balloon catheter.