Transluminal delivery system

Patent metadata

Field	Value
Publication number	US-2022175526-A1
Application number	US-202117399594-A
Country	US
Kind code	A1
Filing date	Aug 11, 2021
Priority date	Dec 3, 2020
Publication date	Jun 9, 2022
Grant date	—

Abstract

A delivery tool including a shaft and a proximal capsule and a distal capsule is dimensioned for percutaneous delivery to the heart. An open end of the proximal capsule faces the open end of the distal capsule. The capsules are coupled to the shaft in a manner that allows axial movement of the capsule with respect to the shaft. A prosthetic heart valve includes a tubular portion that defines a lumen and prosthetic leaflets disposed within the lumen. The prosthetic heart valve is restrainable in a compressed state by the delivery tool, such that a downstream end of the tubular portion is disposed within the distal capsule. The distal capsule is shaped so as to define an opening for visualizing ensheathing of at least a portion of the downstream end of the tubular portion within the distal capsule. Other embodiments are also described.

First claim

1 . Apparatus for use at a heart of a subject, the apparatus comprising:
a delivery tool dimensioned for percutaneous delivery to the heart, the delivery tool having a distal portion that defines a central longitudinal axis at the distal portion and comprises:
a shaft; and
a proximal capsule and a distal capsule, each of the capsules:
having a respective open end, the open end of the proximal capsule facing the open end of the distal capsule, and
coupled to the shaft in a manner that allows axial movement of the capsule with respect to the shaft, along the central longitudinal axis at the distal portion; and

a prosthetic heart valve comprising:
a tubular portion that defines a lumen; and
a plurality of prosthetic leaflets disposed within the lumen,

wherein:
the prosthetic heart valve is restrainable in a compressed state by the delivery tool, such that a downstream end of the tubular portion is disposed within the distal capsule, and
the distal capsule is shaped so as to define an opening for visualizing ensheathing of at least a portion of the downstream end of the tubular portion within the distal capsule.

2 . The apparatus according to claim 1 , wherein the opening defines a window.

3 . The apparatus according to claim 1 , wherein the delivery tool further comprises a mount surrounding the shaft and configured to engage the downstream end of the tubular portion, and wherein the opening is configured to allow visualizing of the mount and the downstream end of the tubular portion.

4 . The apparatus according to claim 3 , wherein the mount is shaped so as to define one or more slots, and wherein the downstream end of the tubular portion is shaped so as to define one or more adaptors, each one of the adaptors being configured to be received within a respective one of the one or more slots so as to facilitate engaging between the mount and the downstream end of the tubular portion.

5 . The apparatus according to claim 4 , wherein in the compressed state of the prosthetic heart valve, the distal capsule maintains coupling between the downstream end of the tubular portion and the mount by surrounding the one or more adaptors and maintaining each one of the one or more adaptors within the respective slot of the mount.

6 . The apparatus according to claim 1 , wherein the prosthetic heart valve comprises:
an upstream support portion that extends from the tubular portion; and a plurality of flanges, each of the flanges coupled to the tubular portion at a respective coupling point that is downstream of the upstream support portion, and extends from the coupling point to a respective flange end-portion of the flange.

7 . The apparatus according to claim 6 , wherein the prosthetic heart valve is restrainable in the compressed state by the delivery tool such that the upstream support portion and the flange end-portions are disposed within the proximal capsule.

8 . A method for preparing a prosthetic heart valve for implantation, the method comprising:
using a crimping tool, crimping the prosthetic heart valve around a distal portion of a shaft of a delivery tool; and subsequently to the crimping, ensheathing the prosthetic heart valve in a capsule by extracorporeally (i) coupling an ensheathing tool directly to the distal portion and (ii) applying a rotational force to the ensheathing tool to effect linear movement of the capsule with respect to the prosthetic heart valve.

9 . The method according to claim 8 , further comprising:
subsequently to the ensheathing, advancing the ensheathed prosthetic heart valve and the distal portion of the delivery tool into a subject, while retaining a proximal portion of the delivery tool outside of the subject; and subsequently, deploying the prosthetic heart valve within a heart of the subject from the capsule by extracorporeally applying an unsheathing force to a controller at the proximal portion of the delivery tool.

10 . The method according to claim 8 , wherein:
the capsule is a distal capsule, the delivery tool further includes a proximal capsule, each of the proximal and distal capsules:
having a respective open end, the open end of the proximal capsule facing the open end of the distal capsule, and
being coupled to the shaft in a manner that allows axial movement of the capsule with respect to the shaft, along a central longitudinal axis at the distal portion; and
ensheathing the prosthetic heart valve in the capsule comprises:
ensheathing a downstream end of the prosthetic heart valve in the distal capsule; and
subsequently, ensheathing an upstream end of the prosthetic heart valve in the proximal capsule.

11 . The method according to claim 10 , wherein the ensheathing tool is a distal-capsule ensheathing tool and wherein ensheathing the downstream end of the prosthetic heart valve comprises applying a first ensheathing force to the distal portion of the delivery tool using the distal-capsule ensheathing tool directly coupled to the distal capsule.

12 . The method according to claim 11 , further comprising coupling the distal-capsule ensheathing tool directly to the distal capsule.

13 . The method according to claim 11 , wherein ensheathing the upstream end of the prosthetic heart valve in the proximal capsule comprises applying a second ensheathing force to the distal portion of the delivery tool using a proximal-capsule ensheathing tool directly coupled to the distal portion.

14 . The method according to claim 13 , further comprising:
subsequently to the ensheathing the of the upstream end of the prosthetic heart valve, advancing the ensheathed prosthetic heart valve and the distal portion of the delivery tool into a heart of a subject, while retaining a proximal portion of the delivery tool outside of the subject; and subsequently, deploying the prosthetic heart valve within the heart of the subject from the proximal and distal capsules by extracorporeally applying an unsheathing force to a controller at the proximal portion of the delivery tool.

15 . The method according to claim 10 , further comprising, during the ensheathing of the downstream end of the prosthetic heart valve in the distal capsule, visualizing the ensheathing of at least a portion of the downstream end of the prosthetic heart valve within the distal capsule through an opening defined in the distal capsule for visualizing the ensheathing.

16 . The method according to claim 15 , wherein the delivery tool further includes a mount surrounding the shaft and configured to engage the downstream end of the prosthetic heart valve, and wherein visualizing the ensheathing of the at least the portion of the downstream end of the prosthetic heart valve within the distal capsule comprises visualizing the mount and the downstream end of the prosthetic heart valve.

17 . The method according to claim 16 , wherein:
the mount is shaped so as to define one or more slots, the downstream end of the prosthetic heart valve is shaped so as to define one or more adaptors, each one of the adaptors being configured to be received within a respective one of the one or more slots so as to facilitate engaging between the mount and the downstream end of the prosthetic heart valve, and ensheathing the downstream end of the prosthetic heart valve in the distal capsule comprises ensheathing the downstream end of the prosthetic heart valve such that the one or more adapters fit within the one or more slots.

18 . The method according to claim 17 , wherein ensheathing the downstream end of the prosthetic heart valve in th

Assignees

• Cardiovalve Ltd

Inventors

• Albitov Michael
• Karalnik Maxim
• Iamberger Meni
• Hariton Ilia
• Hammer Tal

Classifications

• A61B2017/00477

  Coupling (A61B2017/0046 takes precedence) · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2/9522

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

• A61B90/50

  Supports for surgical instruments, e.g. articulated arms · CPC title