Quick-connect prosthetic heart valve

• US 9,005,278 B2
• Filed: 10/25/2012
• Issued: 04/14/2015
• 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, Quinggang, Cristea, Carey L., Kalam, Faisal
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US13/660,780
• Publication Number:
  US 20130053949A1
• Time in Patent Office: 901 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.14, 623/2.17, 623/2.18
• 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 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.

Claims

1. A prosthetic heart valve, comprising:

a non-expandable, non-collapsible prosthetic valve defining a flow orifice therethrough comprising a non-expandable, non-collapsible rigid component supporting blood flow-occluding leaflets and having a sewing ring surrounding an inflow or distal end thereof, and an expandable coupling stent having an outflow or proximal end in contact with and continuously sutured to the rigid component, the coupling stent extending from the rigid component in a distal direction, the coupling stent having a contracted state for delivery to an implant position and an expanded state configured for outward contact with a surrounding heart valve annulus.

2. The heart valve of claim 1, wherein the coupling stent is plastically expandable.

3. The heart valve of claim 1, wherein the coupling stent is self-expandable.

4. The heart valve of claim 1, wherein the contracted state of the coupling stent is generally conical, tapering inward in the distal direction.

5. The heart valve of claim 1, 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.

6. The heart valve of claim 1, wherein the coupling stent is covered with fabric.

7. The heart valve of claim 1, wherein the proximal end of the coupling stent includes a plurality of apertures through which sutures are passed to attach the coupling stent to the rigid component.

8. The heart valve of claim 1, wherein the sewing ring has an undulating contour and the proximal end of the coupling stent follows an undulating path with alternating arcuate troughs and peaks so as to conform to the undulating contour of the sewing ring.

9. The heart valve of claim 8, wherein the coupling stent has a series of axially-extending struts at least some of which are in-phase with the peaks and the middle of the troughs of the proximal end of the coupling stent.

10. The heart valve of claim 1, wherein the proximal 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.

11. The heart valve of claim 1, wherein the proximal end of the coupling stent includes an interrupted reinforcing ring comprising a series of short lengths separated by gaps.

12. A prosthetic heart valve, comprising:

a non-expandable, non-collapsible prosthetic valve defining a flow orifice therethrough with blood flow-occluding leaflets, the valve having a non-expandable, non-collapsible rigid component with an inflow or distal end, and a plastically-expandable coupling stent having an outflow or proximal end with a periphery in contact with and continuously sutured to the distal end of the rigid component, the coupling stent extending from the valve in a distal direction, the coupling stent having a contracted state that is generally conical, tapering inward in the distal direction for delivery to an implant position and an expanded state that flares outward in the distal direction for outward contact with a surrounding heart valve annulus, wherein the proximal 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.

13. The heart valve of claim 12, 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.

14. The heart valve of claim 12, wherein the coupling stent is covered with fabric.

15. The heart valve of claim 12, wherein the proximal end of the coupling stent includes a plurality of apertures through which sutures are passed to attach the coupling stent to the rigid component.

16. The heart valve of claim 12, wherein the valve includes a sewing ring surrounding the distal end thereof having an undulating contour and the reinforcing ring follows an undulating path with alternating arcuate troughs and peaks so as to conform to the undulating contour of the sewing ring.

17. The heart valve of claim 16, wherein the reinforcing ring includes a series of spaced apertures through which sutures are looped to attach the coupling stent to the rigid component.

18. The heart valve of claim 16, wherein the coupling stent has a series of axially-extending struts at least some of which are in-phase with the peaks and the middle of the troughs of the reinforcing ring.

19. A prosthetic heart valve, comprising:

a non-expandable, non-collapsible prosthetic valve defining a flow orifice therethrough with blood flow-occluding leaflets, the valve having a non-expandable, non-collapsible rigid component with an inflow or distal end, and a plastically-expandable coupling stent having an outflow or proximal end with a periphery in contact with and continuously sutured to the distal end of the rigid component, the coupling stent extending from the valve in a distal direction, the coupling stent having a contracted state that is generally conical, tapering inward in the distal direction for delivery to an implant position and an expanded state that flares outward in the distal direction for outward contact with a surrounding heart valve annulus

wherein the proximal end of the coupling stent includes an interrupted reinforcing ring comprising a series of short lengths separated by gaps.

20. The heart valve of claim 19, wherein the valve includes a sewing ring surrounding the distal end thereof having an undulating contour and the reinforcing ring follows an undulating path with alternating arcuate troughs and peaks so as to conform to the undulating contour of the sewing ring.

21. The heart valve of claim 20, wherein the reinforcing ring includes a series of spaced apertures through which sutures are looped to attach the coupling stent to the rigid component.

22. The heart valve of claim 20, wherein the coupling stent has a series of axially-extending struts at least some of which are in-phase with the peaks and the middle of the troughs of the reinforcing ring.