TAVR load force reduction

Patent metadata

Field	Value
Publication number	US-12514703-B2
Application number	US-202217710106-A
Country	US
Kind code	B2
Filing date	Mar 31, 2022
Priority date	Mar 31, 2021
Publication date	Jan 6, 2026
Grant date	Jan 6, 2026

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

The invention claimed is:

1 . A valve loading system, comprising:
a delivery device for a prosthetic valve, the delivery device including an outer shaft and a distal sheath connected to the outer shaft, the distal sheath being sized to receive the prosthetic valve in a collapsed condition; a loading tube sized to receive the prosthetic valve, the loading tube having a proximal end defining a proximal opening having a proximal opening diameter; and a grip adjacent the proximal end of the loading tube, the grip comprising:
a body having an external diameter greater than the proximal opening diameter and a body lumen extending therethrough, the body lumen having a diameter, an axis extending in a longitudinal direction, and an inner annular surface oriented at an acute angle to the longitudinal direction; and
a deformable member positioned in the body, the deformable member having a deformable lumen with an axis that is colinear with the axis of the body lumen, an undeformed diameter sized to receive the outer shaft therethrough, a first surface facing the inner annular surface of the body lumen and oriented at an oblique angle to the longitudinal direction, and a second surface opposite the first surface and oriented substantially orthogonal to the longitudinal direction, the deformable member being compressible in the longitudinal direction against the inner annular surface of the body to reduce the diameter of the deformable lumen, whereby the deformable member exerts a force on the outer shaft that limits movement of the loading tube relative to the outer shaft.

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

3 . The valve loading system of claim 1 , further comprising a fitting that is movable relative to the body along a loading axis, and the diameter of the deformable lumen changes in response to movement of the fitting within a range of positions relative to the body.

4 . The valve loading system 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 deformable lumen changes in response to movement of the first component within a range of positions relative to the second component.

5 . The valve loading system of claim 4 , wherein the deformable member is an annular gasket defining the deformable 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 valve loading system 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 valve loading system of claim 4 , wherein the first component is a screw threadedly engaged with the second component.

8 . The valve loading system of claim 4 , wherein the second component is a case, and a portion of the first component extends out of the case.

9 . A valve loading system, comprising:
a delivery device for a prosthetic valve, the delivery device including an outer shaft and a distal sheath connected to the outer shaft, the distal sheath being sized to receive the prosthetic valve in a collapsed condition; a loading tube sized to receive the prosthetic valve, the loading tube having a proximal end defining a proximal opening having a proximal opening diameter; and a releasable grip adjacent the proximal end of the loading tube, the grip including:
a case having an external diameter greater than the proximal opening diameter, the case being axially aligned with the loading tube and 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, the case having an axis extending in a longitudinal direction and an inner annular surface oriented at an acute angle to the longitudinal direction;
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 deformable 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 in the longitudinal direction through the grip, the central opening of the gasket having an undeformed diameter sized to receive the outer shaft therethrough, the gasket having a first surface facing the inner annular surface of the case and oriented at an oblique angle to the longitudinal direction, and a second surface opposite the first surface and oriented substantially orthogonal to the longitudinal direction, the gasket being compressible in the longitudinal direction against the inner annular surface of the case to reduce the diameter of the central opening, whereby the gasket exerts a force on the outer shaft that limits movement of the loading tube relative to the outer shaft.

10 . 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 and the prosthetic valve is pulled proximally into the distal sheath.

11 . The method of claim 10 , 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

• A61F2/9517 Primary

  handle assemblies therefor · 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

• A61F2250/0039

  differing in diameter · CPC title

• A61F2/9525

  using a funnel · CPC title