Anatomical oscillation and fluctuation sensing and confirmation system

Patent metadata

Field	Value
Publication number	US-12490937-B2
Application number	US-202217747903-A
Country	US
Kind code	B2
Filing date	May 18, 2022
Priority date	May 18, 2021
Publication date	Dec 9, 2025
Grant date	Dec 9, 2025

Abstract

Disclosed herein is a system and method directed to detecting placement of a medical device within a patient body, where the system includes a medical device including an optical fiber having core fibers, each of the one or more core fibers including a plurality of sensors each configured to (i) reflect a light signal having an altered characteristic due to strain experienced by the optical fiber. The system further includes logic configured to cause operations of providing an incident light signal to the optical fiber, receiving reflected light signals of different spectral widths of the incident light from the sensors, processing the reflected light signals to detect fluctuations of a portion of the optical fiber, and determining a location of the portion of the optical fiber based on the detected fluctuations. In some instances, the detected fluctuations are caused by anatomical movement of the patient body.

First claim

What is claimed is:

1 . A medical device system for detecting placement of a medical device within a patient body, the system comprising:
the medical device comprising an optical fiber having one or more core fibers, each of the one or more core fibers including a plurality of sensors distributed along a longitudinal length of a corresponding core fiber and each sensor of the plurality of sensors being configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber; and a console including one or more processors and a non-transitory computer-readable medium having stored thereon logic, when executed by the one or more processors, causes operations including:
providing an incident light signal to the optical fiber;
receiving reflected light signals of different spectral widths of the incident light signal by one or more of the plurality of sensors;
processing the reflected light signals associated with a distal subset of the plurality of sensors of the one or more core fibers to identify wavelength shifts in the reflected light signals resulting in detection of fluctuations of a distal portion of the optical fiber; and
determining a location of the distal portion of the optical fiber in the patient body at which the distal portion is disposed based on the detected fluctuations by correlating the identified wavelength shifts from the distal subset of the plurality of sensors with previously detected wavelength shifts.

2 . The system of claim 1 , wherein the detected fluctuations are caused by anatomical movement of the patient body within which the medical device is disposed.

3 . The system of claim 2 , wherein the anatomical movement corresponds to pulses of a heart of the patient body.

4 . The system of claim 2 , wherein the anatomical movement corresponds to movement of one or both lungs of the patient body.

5 . The system of claim 1 , wherein the determined location of the distal portion of the optical fiber is within a Superior Vena Cava (SVC) of the patient body.

6 . The system of claim 1 , wherein the optical fiber is a multi-core optical fiber including a plurality of core fibers.

7 . The system of claim 1 , wherein determining a location includes determining whether a correlation result is above a first threshold.

8 . The system of claim 7 , wherein previously obtained reflected light signals correspond to previously detected fluctuations at a known location within a human body.

9 . The system of claim 7 , wherein the correlating is performed through machine-learning techniques.

10 . The system of claim 1 , wherein determining the location of the portion of the distal optical fiber includes
obtaining electrocardiogram (ECG) signals, correlating the ECG signals with the detected fluctuations to identify whether the detected fluctuations include movements in accordance with a rhythmic pattern of the ECG signals, and determining whether a correlation result is above a first threshold.

11 . The system of claim 1 , wherein the medical device is one of an introducer wire, a guidewire, a stylet, a stylet within a needle, a needle with the optical fiber inlayed into a cannula of the needle, or a catheter with the optical fiber inlayed into one or more walls of the catheter.

12 . The system of claim 1 , wherein each of the plurality of sensors is a reflective grating, where each reflective grating alters its reflected light signal by applying a wavelength shift dependent on a strain experienced by the reflective grating.

13 . The system of claim 1 , wherein the operations further include performing a confirmation operation on the location in the patient body at which the distal portion of the optical fiber is disposed based on the detected fluctuations, wherein the confirmation operation includes use of one or more of a detected shape of the medical device, an insertion length of the medical device, or a temperature sensed at a distal portion of the medical device.

14 . A method for detecting placement of a medical device within a patient body, the method comprising:
providing an incident light signal to an optical fiber included within the medical device, wherein the optical fiber includes one or more core fibers, each of the one or more of core fibers including a plurality of reflective gratings distributed along a longitudinal length of a corresponding core fiber and each of the plurality of reflective gratings being configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber; receiving reflected light signals of different spectral widths of the incident light signal by one or more of a plurality of sensors;
processing the reflected light signals associated with a distal subset of the plurality of sensors of the one or more core fibers to identify wavelength shifts in the reflected light signals resulting in detection of fluctuations of a distal portion of the optical fiber; and
determining a location of the distal portion of the optical fiber in the patient body at which the distal portion is disposed based on the detected fluctuations by correlating the identified wavelength shifts from the distal subset of the plurality of sensors with previously detected wavelength shifts.

15 . The method of claim 14 , wherein the detected fluctuations are caused by anatomical movement of the patient body within which the medical device is disposed.

16 . The method of claim 15 , wherein the anatomical movement corresponds to pulses of a heart of the patient body.

17 . The method of claim 15 , wherein the anatomical movement corresponds to movement of one or both lungs of the patient body.

18 . The method of claim 14 , wherein the determined location of the distal portion of the optical fiber is within a Superior Vena Cava (SVC) of the patient body.

19 . The method of claim 14 , wherein the optical fiber is a multi-core optical fiber including a plurality of core fibers.

20 . The method of claim 14 , wherein determining a location includes determining whether a correlation result is above a first threshold.

21 . The method of claim 20 , wherein previously obtained reflected light signals correspond to previously detected fluctuations at a known location within a human body.

22 . The method of claim 20 , wherein the correlating is performed through machine-learning techniques.

23 . The method of claim 14 , wherein determining the location of the distal portion of the optical fiber includes:
obtaining electrocardiogram (ECG) signals, correlating the ECG signals with the detected fluctuations to identify whether the detected fluctuations include movements in accordance with a rhythmic pattern of the ECG signals, and determining whether a correlation result is above a first threshold.

24 . The method of claim 14 , wherein the medical device is one of an introducer wire, a guidewire, a stylet, a stylet within a needle, a needle with the optical fiber inlayed into a cannula of the needle or a catheter with the optical fiber inlayed into one or more walls of the catheter.

25 . The method of claim 14 , wherein each of the plurality of sensors is a reflective grating, wher

Assignees

• Bard Access Systems Inc

Inventors

• Sowards Steffan
• Misener Anthony K
• Mclaughlin William Robert
• Messerly Shayne

Classifications

• A61B2562/0266

  Optical strain gauges · CPC title

• A61B5/6852

  Catheters · CPC title

• A61B5/7246

  using correlation, e.g. template matching or determination of similarity · CPC title

• A61B5/113

  occurring during breathing · CPC title

• A61B5/065 Primary

  Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe · CPC title