IP Library Granted Patent US 11,684,474
Granted Patent B2
US 11,684,474 · App. 16/934,879 · Granted Jun 27, 2023

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 (Costa Mesa, 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 11,684,474
App. No.
16/934,879
Granted
Jun 27, 2023
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 disclosure can use the crimping/tensioning of sutures in order to re-crimp the replacement valve after release, though longitudinal or rotational forces.

Claims (28)

1. A delivery system for a replacement valve, the delivery system comprising:

a tether configured to releasably hold a replacement valve;

a torqueing manifold configured to retain a first end of the tether;

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 tether;

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;

a bearing rotatably retained within the torqueing manifold; and

a pin lock shaft having a release plate located proximal of the 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;

wherein longitudinal translation of the engagement pin from the locked position to the unlocked position releases the second end of the tether and the replacement valve from the delivery system; and

wherein rotational movement of the torqueing manifold with respect to the engagement pin is configured to crimp or uncrimp a portion of the replacement valve.

2. The delivery system of claim 1 , wherein circumferential rotation of the manifold shaft with respect to the pin lock shaft is configured to crimp or uncrimp the portion of the replacement valve.

3. The delivery system of claim 1 , wherein the engagement pin extends between the release plate and the bearing in the locked position, and wherein the second end of the tether is retained on the engagement pin between the release plate and the bearing in the locked position.

4. The delivery system of claim 1 , 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 the tether from the engagement pin.

5. The delivery system of claim 1 , wherein the torqueing manifold comprises a plurality of distally extending protrusions extending around an outer circumference of the distal end of the torqueing manifold.

6. The delivery system of claim 1 , wherein the engagement pin is generally L-shaped.

7. The delivery system of claim 1 , further comprising the replacement valve, wherein the replacement valve is a replacement mitral valve.

8. The delivery system of claim 1 , wherein the tether is configured to pass through an eyelet of the replacement valve.

9. A method of releasing a replacement valve from a delivery system, the method comprising:

expanding the replacement valve from a compressed configuration to an expanded configuration, the replacement valve having a distal end and a proximal end, the replacement valve releasably attached to a manifold of the delivery system at a location distal to the replacement valve through at least one tether releasably retained on an engagement pin connected to the manifold in a locked position;

rotating a manifold shaft located radially inwards of the replacement valve in a first direction with respect to a locking shaft, wherein the manifold shaft has the manifold on a distal end located distal to the replacement valve, wherein the at least one tether is connected to the manifold and the locking shaft, and wherein the manifold shaft is located within a lumen of the locking shaft, wherein the rotating the manifold shaft in the first direction loosens the at least one tether to uncrimp the distal end of the replacement valve; and

proximally translating the engagement pin from the locked position to an unlocked position outside of the manifold, thereby releasing the at least one tether and the replacement valve.

10. The method of claim 9 , wherein the expanding the replacement valve comprises:

proximally translating an outer sheath to uncover the proximal end of the replacement valve; and

distally translating a nosecone to uncover the distal end of the replacement valve.

11. The method of claim 9 , further comprising rotating the manifold shaft in a second direction opposite the first direction with respect to the locking shaft to crimp the distal end of the replacement valve.

12. The method of claim 11 , further comprising proximally translating a nosecone to cover the distal end of the replacement valve when the replacement valve is crimped.

13. The method of claim 9 , further comprising proximally translating the locking shaft with respect to the manifold shaft which proximally translates the engagement pin to the unlocked position.

14. The method of claim 9 , wherein the replacement valve is releasably attached to the delivery system via a plurality of tethers connected to a plurality of engagement pins.

15. The method of claim 9 , wherein the replacement valve is a replacement mitral valve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2020
From: SRINIMUKESH, HARISH MANICKAM; OBA, TRAVIS ZENYO; LANDON, DAVID ROBERT; RABITO, GLEN T.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 053525/0236 →
Continuity (3)
Continuation PCTUS2019014999 · Jan 24, 2019
Provisional Application 62622036 · Jan 25, 2018
Related Publication 20200345494A1 · Nov 5, 2020
Cited By (3)
US 12,478,470 US 12,485,007 US 12,533,233