IP Library › Granted Patent US 12,440,335
Granted Patent B2
US 12,440,335 · App. 18/196,375 · Granted Oct 14, 2025

Delivery system for aided replacement valve recapture and repositioning post-deployment

Inventors: Harish Manickam Srinimukesh (Costa Mesa, CA); Travis Zenyo Oba (Yorba Linda, CA); David Robert Landon (Huntington Beach, CA); Glen T. Rabito (Lake Forest, CA)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2439A61F2/2436A61F2220/0008A61F2250/0098
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Quick Facts
Patent No.
US 12,440,335
App. No.
18/196,375
Granted
Oct 14, 2025
Kind
B2
Abstract

Disclosed herein are embodiments of a delivery system which can be used to recapture and/or reposition a replacement valve, such as a replacement mitral valve, after initial deployment of the valve. Embodiments of the delivery system can involve a torqueing manifold that interacts with multiple tethers that are releasably coupled to eyelets of a replacement heart valve. Engagement pins may be configured to releasably retain one end of the tethers.

Claims (36)

1. A delivery system configured for release and recapture of an implant, the delivery system comprising:

a plurality of tethers;

a torqueing manifold located on a distal end of a manifold shaft, wherein the torqueing manifold is:

configured to retain a first end of each of the plurality of tethers;

located radially inwards of a self-expanding replacement heart valve; and

located within a lumen of a locking shaft;

a plurality of engagement pins each configured to move from a locked position to an unlocked position, each of the plurality of engagement pins configured to releasably retain a second end of each of the plurality of tethers;

the self-expanding replacement heart valve having a plurality of eyelets, each of the plurality of tethers extending through a corresponding one of the plurality of eyelets;

wherein translation of each of the plurality of engagement pins from the locked position to the unlocked position releases the second end of each of the plurality of tethers and the replacement heart valve from the delivery system;

wherein rotating the manifold shaft tightens the plurality of tethers to crimp a distal end of the replacement heart valve to recapture the replacement heart valve following release of the replacement heart valve; and

an outer elongate hollow member shaft configured to cover the replacement heart valve when the replacement heart valve is in a collapsed state so as to facilitate recapture of the replacement heart valve following release of the replacement heart valve.

2. The delivery system of claim 1 , wherein each of the plurality of engagement pins is generally L-shaped.

3. The delivery system of claim 1 , further comprising a release plate, wherein each of the plurality of engagement pins extends through the release plate, and wherein proximal translation of the release plate proximally translates the plurality of engagement pins.

4. The delivery system of claim 1 , wherein the torqueing manifold comprises a plurality of teeth on a distal end of the torqueing manifold.

5. The delivery system of claim 1 , wherein each of the plurality of eyelets is positioned within a respective tab extending from a frame of the replacement heart valve.

6. The delivery system of claim 1 , further comprising a marker proximate a distal end of the outer elongate hollow member shaft that allows for visualization by a user.

7. The delivery system of claim 1 , further comprising a nose cone configured to cover a portion of the replacement heart valve.

8. The delivery system of claim 1 , further comprising an inner member configured to retain a first end of the plurality of tethers.

9. The delivery system of claim 8 , wherein rotational movement of the inner member with respect to the plurality of engagement pins is configured to crimp or uncrimp a portion of the replacement heart valve.

10. The delivery system of claim 1 , further comprising a bearing rotatably retained within the torqueing manifold.

11. A delivery system configured for release and recapture of an implant, the delivery system comprising:

a plurality of tethers;

a torqueing manifold located on a distal end of a manifold shaft, located radially inwards of the replacement heart valve and located within a lumen of a locking shaft; and

a manifold shaft having the torqueing manifold on a distal end of the manifold shaft, the torqueing manifold having at least one protrusion extending distally from a distal end of the torqueing manifold; and

a self-expanding replacement heart valve having a plurality of eyelets, each of the plurality of tethers extending through a corresponding one of the plurality of eyelets,

wherein rotating the manifold shaft in a first circumferential direction loosens the plurality of tethers to uncrimp a distal end of the replacement heart valve to release the replacement heart valve, and

wherein rotating the manifold shaft in a second circumferential direction opposite the first circumferential direction tightens the plurality of tethers to crimp the distal end of the replacement heart valve to recapture the replacement heart valve.

12. The delivery system of claim 11 , further comprising an engagement pin configured to move from a locked position to an unlocked position, the engagement pin configured to releasably retain a second end of the plurality of tethers.

13. The delivery system of claim 12 , further comprising a pin lock shaft having a release plate located proximal of a bearing and located on a distal end of the pin lock shaft, wherein the pin lock shaft is configured to engage the engagement pin in the locked position and the unlocked position.

14. The delivery system of claim 13 , wherein the manifold shaft is located within a lumen of the pin lock shaft, wherein the pin lock shaft is configured to longitudinally and rotationally translate with respect to the manifold shaft, and wherein proximal translation of the pin lock shaft releases the engagement pin from the bearing which releases the second end of at least one tether of the plurality of tethers from the engagement pin.

15. The delivery system of claim 13 , further comprising a release plate, wherein the engagement pin extends through the release plate, and wherein proximal translation of the release plate proximally translates the engagement pin.

16. The delivery system of claim 11 , further comprising a nose cone, wherein release of the replacement heart valve is accomplished by proximally translating an outer sheath to uncover a proximal end of the replacement heart valve and distally translating a nose cone to uncover the distal end of the replacement heart valve.

17. The delivery system of claim 16 , further comprising an outer elongate hollow member shaft configured to cover the replacement heart valve when the replacement heart valve is in a collapsed state so as to facilitate recapture of the replacement heart valve following release of the replacement heart valve.

18. The delivery system of claim 11 , wherein the torqueing manifold comprises a plurality of teeth on a distal end of the torqueing manifold.

19. The delivery system of claim 11 , wherein the replacement heart valve is a replacement mitral valve.

20. The delivery system of claim 11 , wherein each of the plurality of eyelets is positioned within a respective tab extending from a frame of the replacement heart valve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 3, 2023
From: SRINIMUKESH, HARISH MANICKAM; OBA, TRAVIS ZENYO; LANDON, DAVID ROBERT; RABITO, GLEN T.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 064482/0426 →
Continuity (4)
Continuation 16934879 · Jul 21, 2020
Continuation PCTUS2019014999 · Jan 24, 2019
Provisional Application 62622036 · Jan 25, 2018
Related Publication 20230277316A1 · Sep 7, 2023
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