TAVR Load Force Reduction

Patent metadata

Field	Value
Publication number	US-2022313435-A1
Application number	US-202217710106-A
Country	US
Kind code	A1
Filing date	Mar 31, 2022
Priority date	Mar 31, 2021
Publication date	Oct 6, 2022
Grant date	—

Abstract

A grip for inhibiting travel of a prosthetic valve loading tube along an outer shaft of a delivery catheter system has a lumen extending therethrough. A portion of the lumen has a variable internal diameter for selective frictional engagement with the outer shaft. In some arrangements, the variable internal diameter is provided by variable compression of a gasket aligned on the lumen. In other arrangements, the variable internal diameter is provided by a portion of the grip that surrounds the lumen and that has at least one circumferential gap of variable width.

First claim

1 . A grip for assembly to an outer shaft of a prosthetic valve delivery system, the grip comprising:
a body having a lumen extending therethrough and a deformable member positioned in the body, the lumen having a diameter and an axis extending in a longitudinal direction, and the deformable member being deformable to reduce the diameter of a variable diameter portion of the lumen.

2 . The grip of claim 1 , wherein the body is integrally connected to a loading tube for receiving a prosthetic valve capsule.

3 . The grip of claim 2 , comprising a movable component that is movable relative to the body along a loading axis along which the loading tube extends, and the diameter of the variable diameter portion changes in response to movement of the movable component within a range of positions relative to the body.

4 . The grip of claim 1 , wherein the body includes a first component and a second component, the first component is movable relative to the second component in the longitudinal direction, and the diameter of the variable diameter portion changes in response to movement of the first component within a range of positions relative to the second component.

5 . The grip of claim 4 , wherein the deformable member is an annular gasket defining the variable diameter portion of the lumen, the gasket being disposed between opposed surfaces of the first component and the second component such that movement of the first component within the range of positions varies compression of the gasket in the longitudinal direction.

6 . The grip of claim 5 , wherein the first component is a fitting, the second component is a case within which the fitting and the gasket are disposed, and the gasket is trapped within a space between the opposed surfaces of the first component and the second component.

7 . The grip of claim 4 , wherein the deformable member includes a plurality of flexible fingers extending in the longitudinal direction from the first component, and the second component defines a cavity within which the first component is disposed, the cavity tapering in the longitudinal direction from a wider end to a narrower end such that movement of the first component within the range of positions toward the narrower end causes the fingers to deflect radially inward toward the axis of the lumen.

8 . The grip of claim 7 , wherein radially inner faces of the fingers taper away from the axis of the lumen with increasing distance from the first component.

9 . The grip of claim 4 , wherein the first component is a screw threadedly engaged with the second component.

10 . The grip of claim 4 , wherein the first component is spring biased relative to the second component to a position within the range of positions at which the variable diameter portion defines a narrowest portion of the lumen.

11 . The grip of claim 4 , wherein the second component is a case, and a portion of the first component extends out of the case.

12 . The grip of claim 1 , wherein the deformable member has a circumference and a gap in the circumference, the gap being of variable width.

13 . The grip of claim 12 , wherein the deformable member has a plurality of flexible elements distributed circumferentially about the variable diameter portion of the lumen, the gap being one of a plurality of gaps each defined between two of the flexible elements.

14 . The grip of claim 12 , wherein the deformable member is a clamp with a tightening screw extending across the gap.

15 . The grip of claim 12 , wherein the deformable member is a cannulated conical frustum.

16 . A valve loading system comprising:
the grip of claim 1 ; and a loading tube for receiving a prosthetic valve capsule, the loading tube having a proximal end defining a proximal opening having a proximal opening diameter that is less than an external diameter of the body.

17 . A valve loading system, comprising:
a loading tube sized to receive a prosthetic valve capsule, the loading tube having a proximal end defining a proximal opening having a proximal opening diameter; and a releasable grip, including:
a case having an external diameter greater than the proximal opening diameter, the case defining an internally threaded channel extending from a first end of the case, an aperture at a second end of the case opposite the first end of the case, and a space between the internally threaded channel and the aperture;
a cannulated screw threadedly engaged with the internally threaded channel and having a head with an external diameter greater than a diameter of the internally threaded channel, the cannulation of the screw being aligned with the aperture; and
an annular gasket trapped within the space, the gasket having a central opening aligned with the cannulation of the screw and the aperture such that the cannulation of the screw, the central opening, and the aperture collectively define a lumen extending through the grip.

18 . A method of loading a prosthetic valve into a delivery system, the method comprising:
assembling a loading tube over a distal sheath and an outer shaft of the delivery system, the loading tube having a lumen with an internal diameter; tightening a grip on the outer shaft to fix the grip relative to the outer shaft at a location proximal of the loading tube and corresponding to an intended limit of proximal travel for the loading tube along the outer shaft, at least a portion of the grip having an external diameter greater than the internal diameter of the loading tube; and applying tension in a proximal direction to an inner shaft extending within the outer shaft and the distal sheath and connected to the prosthetic valve while the prosthetic valve is disposed at a distal end of the loading tube, whereby the grip inhibits movement of the loading tube in the proximal direction relative to the outer shaft.

19 . The method of claim 18 , wherein tightening the grip causes a narrow end of the grip to enter the lumen of the loading tube.

20 . The method of claim 18 , wherein tightening the grip includes turning a first component of the grip relative to a second component of the grip about a loading axis along which the outer shaft extends.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Govek Tyler
• Morrissey Michael Shane

Classifications

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/9517 Primary

  handle assemblies therefor · CPC title

• A61F2/9525

  using a funnel · CPC title

• A61F2220/0041

  using additional screws, bolts, dowels or rivets, e.g. connecting screws · CPC title

• A61F2250/001

  for adjusting a diameter · CPC title