IP Library Granted Patent US 11,998,447
Granted Patent B2
US 11,998,447 · App. 16/811,693 · Granted Jun 4, 2024

Retrievable prosthesis delivery system

Inventors: Keith Alan Jackson (Brooker, FL); Karen Tsoek-Ji Wong (Richmond, CA); Christopher Brodeur (Plymouth, MN); Eric Soun-Sang Fung (Vancouver, CA); Kellen Bodell (Plymouth, MN); Fredericus Antonius Colen (Boca Raton, FL); Shmuel Banai (Tel Aviv, IL); Juzer Banatwala (Vancouver, CA)
Assignee: Neovasc Tiara Inc.
A61F2/2436A61F2/2418A61F2210/0019
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Quick Facts
Patent No.
US 11,998,447
App. No.
16/811,693
Granted
Jun 4, 2024
Kind
B2
Abstract

A prosthetic delivery system may include a plurality of concentric shafts and an actuator mechanism for actuating one or more of the concentric shafts. A stop mechanism may be coupled to the actuator mechanism. The stop mechanism prevents advancement or retraction of at least some of the shafts beyond a predetermined position unless the stop mechanism is released. A second stop mechanism may be included in the system for controlling another of the shafts. A plurality of filaments may be coupled to a prosthesis carried by the delivery system and actuation of the filaments may be used to control deployment or retrieval of the prosthesis.

Claims (43)

1. A method for delivering a prosthesis, said method comprising:

providing a prosthesis carried on a delivery catheter within a capsule, the delivery catheter comprising:

an anchor catheter connected to the prosthesis;

a guidewire catheter extending concentrically with the anchor catheter to connect to the capsule; and

a steerable catheter at least partially surrounding the anchor catheter and the guidewire catheter;

at least partially deploying the prosthesis from the capsule by actuating the guidewire catheter to cause translation between the capsule and the prosthesis; and

retrieving the prosthesis back into the capsule of the delivery catheter by actuating a plurality of filaments coupled to the prosthesis;

wherein the capsule comprises proximal and distal sections that can be axially translated away from each other to deploy the prosthesis, and the proximal and distal sections of the capsule have an outer profile size that is larger than the delivery catheter.

2. The method of claim 1 , further comprising steering the delivery catheter by actuating a tether coupled to the delivery catheter.

3. The method of claim 1 , further comprising adjusting tension on a plurality of stylets connected to the plurality of filaments to control deployment of the prosthesis from the delivery catheter.

4. The method of claim 1 , wherein retrieving the prosthesis back into the capsule of the delivery catheter by actuating a plurality of filaments coupled to the prosthesis comprises operating a tension equalizer to simultaneously control tension on each of the plurality of filaments.

5. The method of claim 1 , wherein at least partially deploying the prosthesis from the capsule comprises fully deploying elbows of ventricular anchors extending from the prosthesis such that the elbows expand radially outward of the capsule by moving the capsule distally with the guidewire catheter.

6. The method of claim 5 , wherein retrieving the prosthesis back into the capsule of the delivery catheter by actuating the plurality of filaments coupled to the prosthesis comprises pulling the elbows radially inward of the capsule by pulling the plurality of filaments proximally, wherein proximal pulling of the plurality of filaments produces radial movement of the elbows that is discrete from axial movement of the prosthesis.

7. The method of claim 5 , wherein the plurality of filaments are attached to the elbows via a single tether extending through loops of each filament and the elbows.

8. The method of claim 1 , further comprising releasing the plurality of filaments to allow full deployment of the prosthesis.

9. The method of claim 8 , wherein releasing the plurality of filaments comprises releasing tension in the plurality of filaments such that opening of the prosthesis via spring action pulls the plurality of filaments from the prosthesis.

10. The method of claim 8 , wherein all of the plurality of filaments are connected in a single loop and releasing the plurality of filaments comprises pulling the single loop from the prosthesis.

11. The method of claim 8 , wherein:

the delivery catheter comprises a handle located at a proximal end of the steerable catheter; and

the capsule is located distally of the steerable catheter and axially translatable relative to the steerable catheter.

12. The method of claim 8 , wherein releasing the plurality of filaments comprises:

moving an anchor plate connected to the prosthesis away from a plurality of slanted tabs around which each of the plurality of filaments is attached, the plurality of slanted tabs extending from an anchor element attached to the delivery catheter, wherein each of the plurality of filaments is trapped between one of the plurality of slanted tabs and the anchor plate;

expanding the prosthesis via spring action to pull the plurality of filaments along the plurality of slanted tabs; and

allowing each of the plurality of filaments to slip off a slanted tab of the plurality of slanted tabs at a gap between the plurality of slanted tabs and the anchor plate due to the spring action.

13. The method of claim 12 , wherein pushing the anchor plate connected to the prosthesis away from each of the slanted tabs to release the plurality of filaments comprises actively pushing the anchor plate with a push rod.

14. The method of claim 12 , wherein pushing the anchor plate connected to the prosthesis away from each of the slanted tabs to release the plurality of filaments comprises passively pushing the anchor plate with a spring.

15. The method of claim 1 , wherein the capsule comprises a rigid body defining an enclosure having an internal space in which the prosthesis is disposed separated from an internal space of the steerable catheter.

16. A method for delivering a mitral valve prosthesis, said method comprising:

partially deploying the mitral valve prosthesis while being carried on a delivery catheter by sliding a sheath away from the mitral valve prosthesis to progressively expose an anchor portion of the mitral valve prosthesis;

deploying from the sheath elbows of ventricular anchors extending from the anchor portion of the mitral valve prosthesis by allowing the elbows to radially expand beyond the anchor portion and the sheath independent of axial movement of the anchor portion; and

applying tension to a plurality of filaments attached to the elbows to collapse the elbows radially inward toward the anchor portion independent of axial movement of the anchor portion and then sliding the sheath toward the mitral valve prosthesis to retrieve the mitral valve prosthesis back into the sheath, wherein the plurality of filaments are attached to the elbows via a single tether extending through loops of each filament and the elbows.

17. The method of claim 16 , further comprising:

fully deploying the mitral valve prosthesis from the catheter;

releasing tension on the plurality of filaments; and

detaching the delivery catheter form the mitral valve prosthesis.

18. The method of claim 17 , further comprising allowing the mitral valve prosthesis to spring open to detach the plurality of filaments from the mitral valve prosthesis, wherein the elbows comprise inferior portions of the ventricular anchors adjacent to connection points of the ventricular anchors with a ventricular skirt extending from the anchor portion, and wherein the ventricular anchors are configured to spring radially outward of the anchor portion of the mitral valve prosthesis when deployed.

19. The method of claim 17 , further comprising operating an anchor device to allow the plurality of filaments to detach from the mitral valve prosthesis.

20. The method of claim 17 , wherein releasing tension on the plurality of filaments comprises:

moving an anchor plate away from a plurality of slanted tabs around which each of the plurality of filaments is attached, the plurality of slanted tabs extending from an anchor element attached to the delivery catheter, wherein each of the plurality of filaments is trapped between one of the plurality of slanted tabs and the anchor plate;

expanding the mitral valve prosthesis via spring action to pull the plurality of filaments along the plurality of slanted tabs; and

allowing each of the plurality of filaments to slip off a slanted tab of the plurality of slanted tabs at a gap between the plurality of slanted tabs and the anchor plate due to the spring action.

21. The method of claim 16 , wherein applying tension to a plurality of filaments attached to the elbows comprises pulling the elbows radially toward a longitudinal axis of the delivery catheter with radially extending portions the plurality of filaments.

22. The method of claim 16 , wherein applying tension to a plurality of filaments attached to the elbows comprises operating an equalizer device to apply tension to each of the plurality of filaments simultaneously.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded May 8, 2023
From: STRUL MEDICAL GROUP, LLC
To: NEOVASC INC.; NEOVASC MEDICAL INC.; NEOVASC TIARA INC.
Reel/Frame 063561/0308 →
CONFIRMATORY ASSIGNMENT OF SECURITY INTEREST Recorded Mar 24, 2022
From: STRUL MEDICAL GROUP, LLC, AS COLLATERAL AGENT
To: STRUL MEDICAL GROUP, LLC
Reel/Frame 060648/0715 →
SECURITY INTEREST Recorded Jun 9, 2020
From: NEOVASC TIARA INC.
To: STRUL MEDICAL GROUP, LLC
Reel/Frame 052886/0278 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 20, 2020
From: JACKSON, KEITH ALAN; WONG, KAREN TSOEK-JI; BRODEUR, CHRISTOPHER; FUNG, ERIC SOUN-SANG; BODELL, KELLEN; COLEN, FREDERICUS ANTONIUS; BANAI, SHMUEL; BANATWALA, JUZER
To: NEOVASC TIARA INC.
Reel/Frame 052440/0881 →
Continuity (2)
Provisional Application 62815832 · Mar 8, 2019
Related Publication 20200281720A1 · Sep 10, 2020
Cited By (1)
US 12,678,279