Systems for quickly delivering a prosthetic heart valve

• US 9,561,100 B2
• Filed: 04/10/2015
• Issued: 02/07/2017
• 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 R., Campbell, Louis A., Huntley, Tammy, Zeng, Qinggang, Cristea, Carey L., Kalam, Faisal
• Primary Examiner(s): Snow, Bruce E
• Application Number:
  US14/684,267
• Publication Number:
  US 20150216656A1
• Time in Patent Office: 669 Days
• US Class Current: 1/1
• 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 system for delivering a prosthetic heart valve, comprising:

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

a valve holder connected to the prosthetic valve of the valve component opposite the coupling stent;

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 lumen, past the holder and through the valve component.

2. The system of claim 1, wherein the prosthetic valve comprises a bioprosthetic valve having flexible bioprosthetic leaflets, and wherein the coupling stent is fabric covered.

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

4. The system of claim 1, 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.

5. The system of claim 1, 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 valve holder to enable manual manipulation of the valve component using the distal section prior to connection with the proximal section.

6. The system of claim 5, wherein the balloon catheter and proximal handle section are packaged together with the balloon within the proximal section lumen.

7. The system of claim 1, wherein the valve component mounted on the holder is packaged separately from the handle and the balloon catheter.

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

a hybrid prosthetic heart valve including both a non-expandable, non-collapsible prosthetic valve and an expandable stent on a distal end, the non-expandable, non-collapsible prosthetic valve surrounding a flow orifice and the expandable stent having a contracted state for delivery to an implant position and an expanded state;

a valve holder connected to the non-expandable, non-collapsible prosthetic valve of the heart valve, the valve holder defining a throughbore;

a handle configured to attach to a proximal end of the valve holder and having a lumen; and

a balloon catheter having a balloon, wherein the balloon catheter slides within the handle lumen and includes a proximal coupling member that is spaced from a proximal end of the handle when the balloon is within the handle lumen and contacts the proximal end of the handle when the balloon is advanced to be located within the expandable stent for expansion thereof.

9. The system of claim 8, wherein the prosthetic valve comprises a bioprosthetic valve having flexible bioprosthetic leaflets, and wherein the expandable stent is a fabric covered coupling stent.

10. The system of claim 8, wherein the contracted state of the expandable stent is conical, tapering down in a distal direction.

11. The system of claim 8, wherein the expanded state of the expandable stent is conical, tapering outward in a distal direction, and the balloon has a larger distal expanded end than a proximal expanded end so as to expand the expandable stent conically outward.

12. The system of claim 8, further including a generally conical nose cone on a distal end of the balloon that extends through the heart valve and engages a distal end of the expandable stent in its contracted state.

13. The system of claim 8, 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 valve holder to enable manual manipulation of the heart valve using the distal section prior to connection with the proximal section.