Quick-connect prosthetic heart valve and methods

• US 8,308,798 B2
• Filed: 12/10/2009
• Issued: 11/13/2012
• 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, Yambao, August, Campbell, Louis, Huntley, Tammy, Zeng, Qinggang, Cristea, Carey, Kalam, Faisal
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US12/635,471
• Publication Number:
  US 20100161036A1
• Time in Patent Office: 1,069 Days
• Field of Search: 623/2.14, 623/2.18, 623/2.17
• US Class Current: 623/2.18
• 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 non-expandable, non-collapsible prosthetic valve, 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, wherein the prosthetic valve comprises a sewing ring surrounding an inflow end, and wherein an outflow end of the coupling stent is continuously sutured to the sewing ring.

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 contracted state of the coupling stent is conical, tapering down in a distal direction.

6. The system of claim 5, 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.

7. 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.

8. 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.

9. The system of claim 1, wherein both the base stent and the coupling stent have a plurality of radially expandable struts between axially-oriented struts, and wherein the coupling stent is rotated so that its axially-oriented struts are out of phase with those of the base stent to increase retention therebetween.

10. The system of claim 1, wherein the coupling stent is self-expandable.

11. The system of claim 1, wherein the coupling stent is covered with fabric to promote tissue in-growth and/or to reduce paravalvular leakage.

12. The system of claim 1, wherein the outflow end of the coupling stent includes a plurality of apertures through which sutures are passed to attach the coupling stent to the sewing ring.

13. The system of claim 12, wherein the outflow end of the coupling stent is defined by a reinforcing ring having the plurality of apertures evenly spaced therealong.

14. The system of claim 1, wherein the sewing ring is undulating and the outflow end of the coupling stent follows an undulating path with alternating arcuate troughs and peaks so as to conform to the undulating sewing ring.

15. The system of claim 1, wherein the outflow end of the coupling stent includes a continuous reinforcing ring that comprises a series of lengths of struts of fixed length connected by thinner bridge portions of variable length.

16. The system of claim 15, wherein the bridge portions are each formed with a radius so that they can be either straightened or bent more to, respectively, widen or narrow the reinforcing ring.

17. The system of claim 15, further including a series of apertures formed in the reinforcing ring that provide anchor points for sutures when securing the stent to the sewing ring.

18. The system of claim 1, wherein the coupling stent has an axial length substantially the same as the base stent.

19. The system of claim 1, wherein the coupling stent has web-like struts extending between a series of axially-extending struts.

20. The system of claim 19, wherein the outflow end of the coupling stent defines a plurality of alternating troughs and peaks, and wherein at least some of the axially-extending struts are in-phase with the peaks and the middle of the troughs.

21. The system of claim 19, wherein the outflow end of the coupling stent defines a plurality of alternating troughs and peaks, and wherein at least some of the axially-extending struts are out-of-phase with the peaks and the middle of the troughs.

22. The system of claim 1, wherein an outflow end of the coupling stent includes an interrupted reinforcing ring comprising a series of short lengths separated by gaps.

23. The system of claim 22, wherein the outflow end of the coupling stent defines a plurality of alternating troughs and peaks, with short lengths of the interrupted reinforcing ring defining the peaks and the middle of the troughs.

24. 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, the base stent having a plurality of expandable web-like struts extending between a series of axially-extending struts, and the coupling stent also having a plurality of expandable web-like struts extending between a series of axially-extending struts, and wherein when the coupling stent is expanded outward into contact with the base stent the coupling stent axial struts are in-phase with the base stent axial struts.

25. 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, the base stent having a plurality of expandable web-like struts extending between a series of axially-extending struts, and the coupling stent also having a plurality of expandable web-like struts extending between a series of axially-extending struts, and wherein when the coupling stent is expanded outward into contact with the base stent the coupling stent axial struts are out-of-phase with the base stent axial struts.