Steerable guiding sheath with ring electrodes and related method of construction

Patent metadata

Field	Value
Publication number	US-12485250-B2
Application number	US-202218088473-A
Country	US
Kind code	B2
Filing date	Dec 23, 2022
Priority date	Dec 7, 2016
Publication date	Dec 2, 2025
Grant date	Dec 2, 2025

Abstract

A guiding sheath has a braided layer for improved deflection characteristics and ring electrodes for electrical sensing, mapping and visualization, wherein lead wires for the ring electrodes are passed through lumened tubing position under the braided layer in a proximal portion of the guiding sheath shaft and above the braided layer in a distal portion of the guiding sheath shaft. Moreover, the hemostatic valve includes an improved friction ring with air vents to reduce the risk of air being introduced into the valve.

First claim

What is claimed is:

1 . A method of constructing a shaft of a guiding sheath, comprising:
providing an inner liner; positioning a lumened lead wire tubing longitudinally alongside an outer surface of the inner liner; positioning a lumened puller wire tubing in contact with the outer surface of the inner liner; forming a braided member with fibers, wherein for a first portion of the shaft, braiding the fibers over the outer surface of the inner liner, the lumened puller wire tubing, and a first portion of the lumened lead wire tubing, and wherein for a second portion of the shaft, braiding the fibers over the outer surface of the inner liner and the lumened puller wire tubing but under a second portion of the lumened lead wire tubing such that the first portion of the lumened lead wire tubing extends beneath the braided member, the second portion of the lumened lead wire tubing extends over the braided member, and the lumened puller wire tubing extends beneath the braided member along an entire length of the shaft; applying an outer layer over the inner liner, the braided fibers, the lumened lead wire tubing, and the lumened puller wire tubing; extending a lead wire through the lumened lead wire tubing; extending a puller wire through the lumened puller wire tubing; mounting a ring electrode on the outer layer; and connecting a distal end of the lead wire to the ring electrode.

2 . The method of claim 1 , wherein forming the braided member with the fibers includes:
positioning the first portion of the lumened lead wire tubing in a first position relative to the inner liner and the fibers; braiding the fibers; stopping the braiding; after the stopping the braiding, positioning the second portion of the lumened lead wire tubing in a second position relative to the inner liner and the fibers; and after the positioning the second portion of the lumened lead wire tubing, resuming the braiding.

3 . The method of claim 1 , wherein the applying an outer layer includes reflowing the outer layer.

4 . The method of claim 3 , wherein the outer layer comprises a reflowable plastic material.

5 . The method of claim 1 , wherein the forming the braided member comprises forming the braided member on the second portion of the shaft with a greater pitch and forming the braided member on the first portion of the shaft with a lesser pitch.

6 . The method of claim 1 , wherein the lumened lead wire tubing has a noncircular cross-section.

7 . The method of claim 1 , wherein the lumened lead wire tubing has a substantially rectangular cross-section.

8 . The method of claim 1 , wherein the extending the lead wire through the lumened lead wire tubing comprises extending the lead wire nonlinearly along a length of the lead wire in a lumen of the lumened lead wire tubing.

9 . The method of claim 1 , wherein the applying the outer layer comprises applying a distal portion and a proximal portion, the distal portion having a lesser durometer than a durometer of the proximal portion.

10 . The method of claim 1 , wherein the forming the braided member comprises forming interstitial spaces that are filled by a material of the outer layer.

11 . The method of claim 1 , further comprising forming a distal ring and affixing a distal end of the puller wire to the distal ring.

12 . The method of claim 1 , further comprising forming a deflection section of the shaft.

13 . The method of claim 12 , wherein the forming the braided member comprises braiding the fibers for the second portion of the shaft proximal of the deflection section.

14 . The method of claim 1 , further comprising providing a control handle and a hemostatic valve.

15 . The method of claim 14 , wherein the hemostatic valve has a friction ring with at least one air vent.

16 . The method of claim 15 , wherein the at least one air vent includes a radial indent.

17 . The method of claim 15 , wherein the at least one air vent includes a radial groove.

18 . The method of claim 14 , wherein the hemostatic valve comprises:
a hub housing comprising proximal and distal ends and a central passage, an end cap mounted on the proximal end of the hub housing and comprising a central opening defining an entry into the central passage of the hub housing, a seal valve member positioned within the central passage of the hub housing and comprising a deformable central opening, the deformable central opening being configured to remain closed in a neutral configuration but to deform upon exertion of axial pressure on the deformable central opening by a device to allow passage of the device when the device is extended through the central passage, and a friction ring positioned within the central passage of the hub housing distal of the seal valve member and comprising a central aperture that remains open and is axially aligned with the deformable opening of the seal valve member, the central aperture of the friction ring configured for frictional contact with the device when the device is extended through the central passage, and configured to minimize passage of air distally from the central opening of the seal valve member as the device is extended through the central passage.

19 . The method of claim 1 , further comprising positioning a second lumened puller wire tubing in contact with the outer surface of the inner liner and extending a second puller wire through the second lumened puller wire tubing, wherein the forming the braided member comprises, for the first portion of the shaft, braiding the fibers over the outer surface of the inner liner, the lumened puller wire tubing, the second lumened puller wire tubing, and the first portion of the lumened lead wire tubing, and for the second portion of the shaft, braiding the fibers over the outer surface of the inner liner, the lumened puller wire tubing, and the second lumened puller wire tubing but under the second portion of the lumened lead wire tubing such that the first portion of the lumened lead wire tubing extends beneath the braided member, the second portion of the lumened lead wire tubing extends over the braided member, and both the lumened puller wire tubing and the second lumened puller wire tubing extend beneath the braided member along the entire length of the shaft.

20 . The method of claim 1 , wherein the lumened lead wire tubing comprises a plurality of lumens.

Assignees

• Biosense Webster Israel Ltd

Inventors

• Tang Raymond Yue-Sing
• Raze Brian
• Griffin Mark
• Gratz Eric
• Young Cortney
• Bielefeld Eric E

Classifications

• A61M2025/0037

  characterized by lumina being arranged side-by-side · CPC title

• A61M2025/0034

  characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores · CPC title

• A61M25/0133

  Tip steering devices · CPC title

• A61M25/0053

  having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid · CPC title

• B29L2031/7548

  Cannulas · CPC title