RETAINING MECHANISMS FOR PROSTHETIC VALVES

• US 20120022633A1
• Filed: 07/22/2011
• Published: 01/26/2012
• Est. Priority Date: 07/23/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Ma, Minh, Curtis, Alison S., Olson, Christopher, Rabito, Glen T., Armer, Dustin P., Marr, Devin, Huang, Mark, Okabe, Hiroshi, Stewart, Kevin, Corso, Philip P. Jr.
• Granted Patent: US 9,326,853 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 system, comprising:

one or more support stent delivery catheters;

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

an expandable support stent releasably coupled to the one or more support stent delivery catheters; and

an expandable prosthetic valve releasably coupled to the one or more prosthetic valve delivery catheters.

2. ) The system of claim 1), further comprising a main catheter 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 outer catheter, the stent delivery outer catheter having a distal end with an outer fork portion that comprises a plurality of flexible outer prongs; and

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

the expandable support stent comprising a plurality of retaining arms, the retaining arms of the expandable 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 comprise:

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

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

the expandable prosthetic valve comprising a plurality of retaining arms, the retaining arms of the expandable prosthetic valve 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.

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

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

a plurality of wires at least partially positioned in the interior of the stent delivery outer catheter, each of the wires having a distal end,

the expandable support stent comprising a plurality of retaining arms, the retaining arms of the expandable support stent being releasably connected to corresponding ones of the outer prongs of the outer fork portion and corresponding ones of the distal ends of the wires.

6. ) The system of claim 1), wherein the one or more prosthetic valve delivery catheters comprise:

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

a plurality of wires at least partially positioned in the interior of the prosthetic valve delivery outer catheter, each of the wires having a distal end,

the expandable prosthetic valve comprising a plurality of retaining arms, the retaining arms of the expandable prosthetic valve being releasably connected to corresponding ones of the outer prongs of the outer fork portion and corresponding ones of the distal ends of the wires.

7. ) 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 expandable 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.

8. ) The system of claim 7) wherein the expandable support stent is releasably coupled to the one or more support stent delivery catheters by a system of outer prongs and inner prongs or a system of prongs and wires.

9. ) The system of claim 1), further comprising a nose cone, the nose cone being connected to a distal end of one of the one or more valve delivery catheters.

10. ) The system of claim 1), wherein the expandable 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 a prosthetic valve when the patient'"'"'s heart valve has been replaced by the prosthetic valve.

11. ) An apparatus, comprising:

a support stent having an annular body that defines one or more peaks and one or more valleys along its circumference,

the support stent being radially compressible into a compressed state and self expandable into an uncompressed state,

the support stent being sized such that it can be positioned within the aorta of a patient at a location adjacent to the aortic valve and thereby circumscribe the aortic valve,

one or more covers that at least partially cover the annular body of the support stent, the one or more covers comprising a biocompatible material.

12. ) The apparatus of claim 11), wherein each of the one or more valleys of the support stent are at least partially covered by respective ones of the one or more covers.

13. ) The apparatus of claim 11), wherein the one or more covers cover both an inward-facing and outward-facing surface of a portion of the support stent and only an inward-facing surface of another portion of the support stent.

14. ) The apparatus of claim 11), wherein the one or more covers comprise a plurality of tubular covers that at least partially cover the annular body of the support stent.

15. ) The apparatus of claim 11), wherein the one or more covers comprise one or more covers that extend across one or more of the valleys defined by the support stent.

16. ) The apparatus of claim 11), wherein the biocompatible material is a biocompatible silicone, cloth, or foam.

17. ) A method, comprising:

delivering a support structure to a position on or adjacent to the surface of the outflow side of the aortic valve using a first delivery system that is advanced through the ascending aorta toward the outflow side of the aortic valve of a patient;

delivering an expandable prosthetic valve into the aortic valve and into a support-structure interior using a second delivery system separate from the first delivery system, the second delivery system also being advanced through the ascending aorta toward the outflow side of the aortic valve of the patient; and

expanding the expandable prosthetic heart valve 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 and while both the first delivery system and the second delivery system are at least partially positioned in the ascending aorta, the expanding of the expandable prosthetic heart valve causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

18. ) The method of claim 17), wherein the delivering the support stent comprises advancing the first delivery system through a carotid artery or subclavian artery, and wherein the delivering the expandable prosthetic heart valve comprises advancing the second delivery system through a femoral artery.

19. ) The method of claim 17), wherein the delivering the expandable prosthetic heart valve comprises advancing the second delivery system through a carotid artery or subclavian artery, and wherein the delivering the support structure comprises advancing the first delivery system through a femoral artery.

20. ) The method of claim 17), further comprising (a) advancing the first delivery system through a left femoral artery and advancing the second delivery system through a right femoral artery, or (b) advancing the first delivery system through the right femoral artery and advancing the second delivery system through the left femoral artery