Retaining mechanisms for prosthetic valves

• US 9,326,853 B2
• Filed: 07/22/2011
• Issued: 05/03/2016
• Est. Priority Date: 07/23/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Olson, Christopher, Rabito, Glen T., Armer, Dustin P., Ma, Minh, Marr, Devin, Huang, Mark, Okabe, Hiroshi, Stewart, Kevin, Curtis, Alison S., Corso, Philip P. Jr.
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US13/188,988
• Publication Number:
  US 20120022633A1
• Time in Patent Office: 1,747 Days
• Field of Search: 623/2.11, 623/1.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/006 modular

Abstract

Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support structure and an expandable prosthetic valve are advanced through the aortic arch of a patient using a delivery system. The support structure is delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior). The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Claims

1. A prosthetic valve delivery system having a distal end and an opposite, proximal end, wherein the distal end of the delivery system is capable of being advanced into a patient'"'"'s heart during a deliver procedure while the proximal end of the delivery system is disposed outside of the patient'"'"'s heart, comprising:

one or more prosthetic valve delivery catheters;

one or more support stent delivery catheters at least partially positioned in an interior of the one or more prosthetic valve delivery catheters;

an expandable support stent having a plurality of retaining arms at a distal end of the support stent, the plurality of retaining arms being releasably coupled to the one or more support stent delivery catheters at the distal end of the support stent, wherein the distal end of the support stent is directed toward the distal end of the delivery system; and

an expandable prosthetic valve releasably coupled to the one or more prosthetic valve delivery catheters, the prosthetic valve being oriented when releasably coupled to the delivery system to replace an aortic valve when the distal end of the delivery system is delivered through a puncture in a left ventricle,

wherein the support stent is configured such that retracting the support stent proximally relative to an elongated nose cone of the delivery system causes the support stent to expand into an expanded state.

2. The system of claim 1, further comprising an elongated and straight-bodied introducer sheath at least partially enclosing the one or more support stent delivery catheters and the one or more prosthetic valve delivery catheters.

3. The system of claim 1, wherein the one or more support stent delivery catheters comprise:

a stent delivery inner fork catheter, the stent delivery inner fork catheter having a distal end with an inner fork portion that comprises a plurality of flexible inner prongs; and

a stent delivery outer fork catheter at least partially positioned in an interior of the stent delivery inner fork catheter, the stent delivery outer fork catheter having a distal end with an outer fork portion that comprises a plurality of flexible outer prongs originating outward of the flexible inner prongs,

the retaining arms of the support stent being releasably connected to corresponding ones of the outer prongs of the outer fork portion and corresponding ones of the inner prongs of the inner fork portion.

4. The system of claim 1, wherein the one or more prosthetic valve delivery catheters comprises a prosthetic valve delivery catheter having a distal balloon portion, the prosthetic valve being disposed around the balloon portion of the prosthetic valve delivery catheter and being releasable from the balloon portion upon inflation and subsequent deflation of the balloon portion.

5. The system of claim 1, wherein the support stent is releasably coupled to the one or more support stent delivery catheters by a system of outer prongs and inner prongs located distally of the expandable support stent.

6. The system of claim 1, wherein the support stent is generally annular and comprises shaped portions configured to frictionally secure native leaflets of a patient'"'"'s heart valve against an exterior surface of the prosthetic valve when the patient'"'"'s heart valve has been replaced by the prosthetic valve.

7. The system of claim 1, wherein the one or more support stent delivery catheters comprise a stent delivery inner fork catheter, and a stent delivery outer fork catheter at least partially positioned in an interior of the stent delivery inner fork catheter;

and wherein the system further comprises;

a nose cone catheter; and

the elongated nose cone connected to a distal end of the nose cone catheter,

wherein the stent delivery inner fork catheter, the stent delivery outer fork catheter, and the support stent are selectively enclosable within the elongated nose cone.

8. The system of claim 1, further comprising:

a nose cone catheter;

the nose cone connected to a distal end of the nose cone catheter; and

an introducer sheath,

the nose cone and the introducer sheath having the same circumference and being configured to selectively enclose the one or more prosthetic valve delivery catheters, the one or more support stent delivery catheters, the support stent, and the prosthetic valve.

9. The system of claim 1, wherein the prosthetic valve is located proximally of the support stent.

10. The system of claim 1, wherein, upon delivery of the prosthetic valve, the prosthetic valve is located concentrically within the support stent, and native leaflets of the patient'"'"'s heart are located radially between the support stent and the prosthetic valve.

11. The system of claim 1, wherein the one or more support stent delivery catheters comprise a stent delivery inner fork catheter, and a stent delivery outer fork catheter at least partially positioned in an interior of the stent delivery inner fork catheter, and

wherein the stent delivery inner fork catheter and the stent delivery outer fork catheter are configured such that distal advancement of the stent delivery inner fork catheter relative to the stent delivery outer fork catheter causes the support stent to be released from the one or more support stent delivery catheters.

12. A prosthetic valve delivery system having a distal end and an opposite, proximal end, wherein the distal end of the delivery system is capable of being advanced into a patient'"'"'s heart during a deliver procedure while the proximal end of the delivery system is disposed outside of the patient'"'"'s heart, comprising:

one or more prosthetic valve delivery catheters;

one or more support stent delivery catheters at least partially positioned in an interior of the one or more prosthetic valve delivery catheters, wherein the one or more support stent delivery catheters comprise;

a stent delivery inner fork catheter; and

a stent delivery outer fork catheter at least partially positioned in an interior of the stent delivery inner fork catheter;

an expandable support stent having a plurality of retaining arms at a distal end of the support stent, the plurality of retaining arms being releasably coupled to the one or more support stent delivery catheters at the distal end of the support stent, wherein the distal end of the support stent is directed toward the distal end of the delivery system; and

an expandable prosthetic valve releasably coupled to the one or more prosthetic valve delivery catheters, the prosthetic valve being oriented when releasably coupled to the delivery system to replace an aortic valve when the distal end of the delivery system is delivered through a puncture in a left ventricle,

wherein the stent delivery inner fork catheter and the stent delivery outer fork catheter of the one or more support stent delivery catheters are configured such that distal advancement of the stent delivery inner fork catheter relative to the stent delivery outer fork catheter causes the support stent to be released from the one or more support stent delivery catheters.

13. The system of claim 12, wherein the one or more prosthetic valve delivery catheters comprises a prosthetic valve delivery catheter having a distal balloon portion, the prosthetic valve being disposed around the balloon portion of the prosthetic valve delivery catheter and being releasable from the balloon portion upon inflation and subsequent deflation of the balloon portion.

14. The system of claim 12, wherein the support stent is generally annular and comprises shaped portions configured to frictionally secure native leaflets of a patient'"'"'s heart valve against an exterior surface of the prosthetic valve when the patient'"'"'s heart valve has been replaced by the prosthetic valve.

15. The system of claim 12, wherein the support stent is configured such that retracting the support stent proximally relative to an elongated nose cone of the delivery system causes the support stent to expand into an expanded state.

16. The system of claim 12, wherein, upon delivery of the prosthetic valve, the prosthetic valve is located concentrically within the expandable support stent, and native leaflets of the patient'"'"'s heart are located radially between the support stent and the prosthetic valve.

17. A prosthetic valve delivery system having a distal end and an opposite, proximal end, wherein the distal end of the delivery system is capable of being advanced into a patient'"'"'s heart during a deliver procedure while the proximal end of the delivery system is disposed outside of the patient'"'"'s heart, comprising:

one or more prosthetic valve delivery catheters;

one or more support stent delivery catheters at least partially positioned in an interior of the one or more prosthetic valve delivery catheters, wherein the one or more support stent delivery catheters comprise;

a stent delivery inner fork catheter, the stent delivery inner fork catheter having a distal end with an inner fork portion that comprises a plurality of flexible inner prongs; and

a stent delivery outer fork catheter at least partially positioned in an interior of the stent delivery inner fork catheter, the stent delivery outer fork catheter having a distal end with an outer fork portion that comprises a plurality of flexible outer prongs originating outward of the flexible inner prongs;

an expandable support stent having a plurality of retaining arms at a distal end of the support stent, the plurality of retaining arms being releasably coupled to corresponding ones of the outer prongs of the outer fork portion of the one or more support stent delivery catheters and corresponding ones of the inner prongs of the inner fork portion of the one or more support stent delivery catheters at the distal end of the support stent, wherein the distal end of the support stent is directed toward the distal end of the delivery system; and

an expandable prosthetic valve releasably coupled to the one or more prosthetic valve delivery catheters, the prosthetic valve being oriented when releasably coupled to the delivery system to replace an aortic valve when the distal end of the delivery system is delivered through a puncture in a left ventricle.

18. The system of claim 17, wherein the one or more prosthetic valve delivery catheters comprises a prosthetic valve delivery catheter having a distal balloon portion, the prosthetic valve being disposed around the balloon portion of the prosthetic valve delivery catheter and being releasable from the balloon portion upon inflation and subsequent deflation of the balloon portion.

19. The system of claim 17, wherein the support stent is generally annular and comprises shaped portions configured to frictionally secure native leaflets of a patient'"'"'s heart valve against an exterior surface of the prosthetic valve when the patient'"'"'s heart valve has been replaced by the prosthetic valve.

20. The system of claim 17, wherein the support stent is configured such that retracting the support stent proximally relative to an elongated nose cone of the delivery system causes the support stent to expand into an expanded state.