System and method of stepped deployment of prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-10945840-B2
Application number	US-201816167676-A
Country	US
Kind code	B2
Filing date	Oct 23, 2018
Priority date	Apr 1, 2014
Publication date	Mar 16, 2021
Grant date	Mar 16, 2021

Abstract

A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.

First claim

What is claimed is:

1. A system for replacing a heart valve of a patient, the system comprising:
a delivery device comprising:
a first tube assembly including an intermediate portion,
a second tube assembly positioned over the first tube assembly;
a primary capsule including a proximal portion and a distal portion, the proximal portion connected to the second tube assembly and slidably disposed over the first tube assembly, the proximal portion axially movable with respect to the distal portion along the first tube assembly; and
a secondary capsule that is a tubular sheath, the secondary capsule slidably disposed over the first tube assembly and within both the proximal portion and the distal portions of the primary capsule.

2. The system of claim 1 , wherein movement of the second tube assembly is directly transferred to the proximal portion of the primary capsule.

3. The system of claim 1 , wherein the second tube assembly is configured to transmit a rotational force onto the proximal portion of the primary capsule.

4. The system of claim 1 , wherein movement of the first tube assembly is directly transferred to the distal portion of the primary capsule.

5. The system of claim 1 , wherein the first tube assembly is configured to transmit a rotational force onto the distal portion of the primary capsule.

6. The system of claim 1 , further comprising a prosthetic heart valve secured to the first tube assembly, the prosthetic heart valve having a stent frame and a valve structure attached to the stent frame, the prosthetic heart valve being expandable from a compressed state to an expanded state.

7. The system of claim 6 , wherein the system is configured to be transitionable between:
a loaded state in which the prosthetic heart valve engages the intermediate portion and an entirety of the prosthetic heart valve is compressively retained within the primary capsule, the primary capsule constraining the prosthetic heart valve in the compressed state;
a partially deployed state in which the prosthetic heart valve engages the intermediate portion and is compressively retained within the secondary capsule, the partially deployed state including the primary capsule at least partially retracted from over the prosthetic heart valve and the secondary capsule at least partially constraining the prosthetic heart valve, the partially deployed state being less compressed than the compressed state and less expanded than a deployed state, and
the deployed state in which the primary and secondary capsules are retracted from over the prosthetic heart valve and the prosthetic heart valve is expanded to the deployed state and released from the intermediate portion.

8. The system of claim 7 , wherein the partially deployed state includes the valve structure of the prosthetic heart valve configured to open and close in concert with a heartbeat.

9. A system for replacing a heart valve of a patient, the system comprising:
a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame, the prosthetic heart valve being expandable from a compressed state to an expanded state; and
a delivery device comprising:
a first tube assembly including an intermediate portion, the prosthetic heart valve secured to the first tube assembly,
a second tube assembly positioned over the first tube assembly,
a primary capsule including a proximal portion and a distal portion, the proximal portion connected to the second tube assembly and slidably disposed over the first tube assembly, the proximal portion axially movable with respect to the distal portion along the first tube assembly, and
a secondary capsule slidably disposed over the first tube assembly and within both the proximal portion and the distal portion of the primary capsule;
wherein the system is configured to be transitionable between:
a loaded state in which the prosthetic heart valve engages the intermediate portion and an entirety of the prosthetic heart valve is compressively retained within the primary capsule, the primary capsule constraining the prosthetic heart valve in the compressed state;
a partially deployed state in which the prosthetic heart valve engages the intermediate portion and is compressively retained within the secondary capsule, the partially deployed state including the primary capsule at least partially retracted from over the prosthetic heart valve and the secondary capsule at least partially constraining the prosthetic heart valve, the partially deployed state being less compressed than the compressed state and less expanded than a deployed state, further wherein the partially deployed state includes the valve structure of the prosthetic heart valve configured to open and close in concert with a heartbeat, and
the deployed state in which the primary and secondary capsules are retracted from over the prosthetic heart valve and the prosthetic heart valve is expanded to the deployed state and released from the intermediate portion.

10. The system of claim 9 , wherein the secondary capsule is a tubular sheath.

11. The system of claim 9 , wherein movement of the second tube assembly is directly transferred to the proximal portion of the primary capsule.

12. The system of claim 9 , wherein the second tube assembly is configured to transmit a rotational force onto the proximal portion of the primary capsule.

13. The system of claim 9 , wherein movement of the first tube assembly is directly transferred to the distal portion of the primary capsule.

14. The system of claim 9 , wherein the first tube assembly is configured to transmit a rotational force onto the distal portion of the primary capsule.

Assignees

• Medtronic Inc

Inventors

• Racchini Joel
• Rothstein Paul
• Sandstrom Jeffrey

Classifications

• A61F2/9524

  Iris-type crimpers · CPC title

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title