Guiding sheath with distal tip locator

Patent metadata

Field	Value
Publication number	US-12465268-B2
Application number	US-202117484729-A
Country	US
Kind code	B2
Filing date	Sep 24, 2021
Priority date	Oct 12, 2020
Publication date	Nov 11, 2025
Grant date	Nov 11, 2025

Abstract

A guiding sheath has a hemostatic valve and a central lumen into which a diagnostic or treatment catheter can be introduced and guided into a patient. The hemostatic valve also includes an electrically conducting element or proximity sensing element on its proximal end that interacts with a second electrically conducting element or proximity sensing element on a proximal end of the diagnostic or treatment catheter that can be passed through the central lumen of the guiding sheath and into the patient's heart. The interaction between the two electrically conducting elements or proximity sensing elements enables the location of the distal end of the diagnostic or treatment catheter in the patient's heart without the need for irradiating the patient.

First claim

What is claimed is:

1 . A system comprising:
a guiding sheath assembly, comprising:
an elongated shaft defining a lumen extending along a longitudinal axis;
a control handle proximal of the shaft, the control handle comprising:
a hemostatic valve on a proximal end of the control handle; and
at least one first electrically conducting element disposed on at least one of the control handle and the hemostatic valve;

a catheter comprising a transseptal needle, the catheter including (1) one or more location sensors configured to output a first signal corresponding to a location of a distal end of the transseptal needle within a patient's heart and (2) at least one second electrically conducting element disposed on a proximal end of the catheter such that the at least one first electrically conducting element is configured to interact with the at least one second electrically conducting element to complete an electrical circuit to output a second signal when the catheter is introduced into the lumen of the elongated shaft; and a mapping system comprising a processor configured to:
receive the first signal from the one or more location sensors corresponding to the location of the distal end of the catheter;
receive the second signal from the completed electrical circuit;
extrapolate the location of a distal end of the guiding sheath assembly based at least in part on the first signal and the second signal; and
determine a distal-most end of the catheter based at least in part on the extrapolated location of the distal end of the guiding sheath assembly.

2 . The system of claim 1 , wherein the at least one first electrically conducting element is located on a proximal end of the hemostatic valve and the at least one second electrically conducting element is located on a proximal end of the catheter.

3 . The system of claim 1 , wherein the circuit can be configured to provide a visual or auditory indicator upon completion of the electrical circuit.

4 . The system of claim 3 , wherein the visual or auditory indicator can be provided to a system configured to interact with the guiding sheath assembly.

5 . The system of claim 1 , wherein the hemostatic valve further comprises:
a valve body extending along the longitudinal axis from a proximal portion to a distal portion of the valve body; and a sensor disposed proximate the proximal portion of the valve body so that when an instrument is inserted into the hemostatic valve, an indication is provided of a predetermined insertion distance of the instrument through the lumen.

6 . The system of claim 1 ,
wherein the at least one first electrically conducting element is located on a proximal end of the hemostatic valve and projects one of outward or inward and completes the circuit with at least one second electrically conducting element on a proximal end of the catheter, the outward direction is away from the lumen of the control handle, and the inward direction is toward the lumen of the control handle.

7 . A system comprising:
a catheter comprising a transseptal needle; a guiding sheath assembly comprising:
an elongated shaft defining a lumen and extending along a longitudinal axis;
a control handle proximal of the elongated shaft and comprising:
a control knob configured for rotation about the longitudinal axis;
a hollow rotatable shaft configured for rotation about the longitudinal axis in response to rotation of the control knob;
a hemostatic valve on a proximal end of the control handle and coupled to the lumen; and

a plurality of first proximity sensing elements disposed asymmetrically about a circumference of at least one of the control handle and the hemostatic valve;
a catheter comprising a transseptal needle, the catheter comprising (1) one or more location sensors configured to output a first signal corresponding to a location of a distal end of the transseptal needle within a patient's heart and (2) a plurality of second proximity sensing elements disposed asymmetrically about a circumference of the catheter so that when the plurality of first proximity sensing elements interacts with the plurality of second proximity sensing elements a second signal; a mapping system comprising a processor configured to:
receive the first signal;
receive the second signal;
extrapolate the location of a distal end of the guiding sheath assembly based at least in part on the first signal and the second signal; and
determine a distal-most end of the catheter based at least in part on the extrapolated location of the distal end of the guiding sheath assembly.

8 . The system of claim 7 , wherein the plurality of first proximity sensing elements is located on a proximal end of the hemostatic valve and the second plurality of proximity sensing elements is located on a proximal end of a dilator of the catheter, the dilator configured to be inserted into the lumen.

9 . The system of claim 7 , wherein the first and second pluralities of proximity sensing elements comprise a photosensor, an optical sensor, a magnetic field sensor, and physically interacting elements.

10 . The system of claim 9 , wherein the plurality of first proximity sensing elements comprises a projection and the plurality of second proximity sensing elements is configured to receive the projection, and wherein an engagement or close proximity of the first and second pluralities of proximity sensing elements provides a visual and/or auditory indicator.

11 . The system of claim 7 , wherein the hemostatic valve further comprises:
a valve body; and a sensor disposed on the valve body so that when the catheter is inserted into the hemostatic valve, an indication is provided of a predetermined insertion distance of the catheter through the lumen.

12 . The system of claim 7 , further comprising:
a first shuttle configured to be driven in a linear first direction along the longitudinal axis by the rotatable shaft in response to the control knob interacting with the rotatable shaft and a second shuttle; and a pinion coupling the first shuttle and the second shuttle, the second shuttle configured to be driven in a second linear direction opposite the first linear direction and along the longitudinal axis by the pinion to cause the guiding sheath to deflect.

13 . The system of claim 12 , further comprising a neutral indicator comprising a first member positioned on the first shuttle, the first member comprising a tapered projection.

14 . The system of claim 13 , further comprising a second member comprising a pair of flexible guide rails such that a fixed end of each flexible guide rail is connected to the second shuttle and a free end of each flexible guide rail together forms a recess that is configured to receive the tapered projection of the first member.

15 . A system comprising:
a guiding sheath assembly, comprising: an elongated shaft defining a lumen extending along a longitudinal axis; a control handle proximal of the elongated shaft, the control handle comprising:
a hemostatic valve comprising;
a valve body extending along a longitudinal axis to define a lumen extending through a portion of the valve body;
a branch conduit in communication with the lumen; and
a seal interposed in the lumen to separate a proximal portion and a distal portion of the valve body, the distal portion in communication with the branch conduit; and

a plurality of first conductive components disposed proximate the hemostatic valve;
a catheter comprising a transseptal needle, the catheter including (1) one or more location sensors configured to output a first sign

Assignees

• Biosense Webster Israel Ltd

Inventors

• Highsmith Debby
• Suarez Paul
• Tran Brandon
• Gomez-Hampton Tara
• Li Elijah

Classifications

• A61B5/287

  Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS] · CPC title

• A61B2562/0223

  Magnetic field sensors · CPC title

• A61B2562/0257

  Proximity sensors · CPC title

• A61M25/09

  Guide wires · CPC title

• A61M39/06

  Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof · CPC title