Reference plane for medical device placement

Patent metadata

Field	Value
Publication number	US-12419694-B2
Application number	US-202217971873-A
Country	US
Kind code	B2
Filing date	Oct 24, 2022
Priority date	Oct 25, 2021
Publication date	Sep 23, 2025
Grant date	Sep 23, 2025

Abstract

A system and method directed to detecting placement of a medical device within a patient body, the system including a medical device including an optical fiber having core fibers. Each of the one or more core fibers can include a plurality of sensors each configured to reflect a light signal having an altered characteristic due to strain experienced by the optical fiber. The system can further include logic configured to determine a 3D shape of the medical device in accordance with the strain of the optical fiber. The logic can be configured to define a reference plane for the 3D shape and render an image of the 3D shape on a display of the system in accordance with the reference plane.

First claim

What is claimed is:

1. A medical device system comprising:
a 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, each sensor of the plurality of sensors 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 by one or more of the plurality of sensors;
processing the reflected light signals associated with the one or more of core fibers to determine a three-dimensional (3D) shape of the optical fiber;
detecting a predetermined subshape of the 3D shape;
defining a reference plane in accordance with the predetermined subshape, wherein the reference plane defines a viewing perspective of the 3D shape; and
orienting the reference plane in 3D space for rendering an image of the 3D shape on a display.

2. The system according to claim 1 , wherein detecting the predetermined subshape includes:
comparing a subshape of the 3D shape with a stored predetermined subshape in memory; and
as a result of the comparing, identifying the subshape as the predetermined subshape of the 3D shape.

3. The system according to claim 2 , wherein:
the memory includes a plurality of stored predetermined subshapes, and
the operations further include selecting the stored predetermined subshape from the plurality of stored predetermined subshapes in memory.

4. The system according to claim 1 , wherein the predetermined subshape is defined by a predetermined pathway of the medical device.

5. The system according to claim 4 , wherein:
the medical device is configured for insertion within a patient body, and
the predetermined pathway is defined by an anatomical pathway of the patient body.

6. The system according to claim 5 , wherein the operations further include:
receiving input from a clinician defining the anatomical pathway of the patient body; and
selecting the stored predetermined subshape according to the input from the clinician.

7. The system according to claim 6 , wherein the input from the clinician includes a location of an insertion site for the medical device.

8. The system according to claim 7 , wherein in use, the clinician inserts the medical device within a pathway of a subshape guide.

9. The system according to claim 5 , wherein the anatomical pathway extends along one or more of a basilic vein, a subclavian vein, an innominate vein, an internal jugular vein, an external jugular vein, or a superior vena cava of the patient body.

10. The system according to claim 4 , wherein the predetermined pathway is external to a patient.

11. The system according to claim 10 , wherein:
the predetermined pathway is defined by a subshape guide of the medical device, and
in use, the medical device is disposed within a pathway of the subshape guide.

12. The system according to claim 11 , wherein the subshape guide is included within a package of the medical device.

13. The system according to claim 12 , wherein the subshape guide is formed integral to the package.

14. The system according to claim 11 , wherein in use, the subshape guide is attached to a patient to maintain an orientation of the predetermined subshape with respect to the patient.

15. The system according to claim 1 , wherein defining the reference plane includes:
identifying a pair of shape segments of the predetermined subshape, and
defining a plane in parallel with both shape segments.

16. The system according to claim 1 , further comprising:
a device guide including a lumen extending along a straight section of the device guide, wherein:
in use, the medical device is inserted within the lumen, and
the operations further include:
interpreting a section of the optical fiber disposed within the straight section as a straight line; and
calibrating the optical fiber in accordance with the straight section.

17. The system according to claim 1 , wherein the medical device is selected from the group consisting 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, and a catheter with the optical fiber inlayed into one or more walls of the catheter.

18. The system according to claim 1 , wherein the operations further include rendering the image of the 3D shape on the display of the system in accordance with the reference plane.

19. A method for detecting placement of a medical device within a patient body, the method comprising:
providing by a system, 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 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 the one or more core fibers to determine a three-dimensional (3D) shape of the optical fiber;
detecting a predetermined subshape of the 3D shape;
defining a reference plane in accordance with the predetermined subshape, wherein the reference plane defines a viewing perspective of the 3D shape; and
orienting the reference plane in 3D space for rendering an image of the 3D shape on a display.

20. The method according to claim 19 , wherein detecting the predetermined subshape includes:
comparing a subshape of the 3D shape with a stored predetermined subshape in memory of the system; and
as a result of the comparing, identifying the subshape as the predetermined subshape of the 3D shape.

21. The method according to claim 20 , further comprising selecting the stored predetermined subshape from a plurality of stored predetermined subshapes in memory.

22. The method according to claim 19 , wherein the predetermined subshape is defined by a predetermined pathway of the medical device.

23. The method according to claim 22 , wherein the predetermined pathway is defined by an anatomical pathway of the patient body.

24. The method according to claim 20 , further comprising:
receiving input from a clinician defining the anatomical pathway of the patient body; and
selecting the stored predetermined subshape according to the input from the clinician.

25. The method according to claim 24 , wherein the input from the clinician includes a location of an insertion site for the medical device.

26. The method according to claim 23 , wherein the anatomical pathway extends along one or more of a basilic vein

Assignees

• Bard Access Systems Inc

Inventors

• Sowards Steffan
• Misener Anthony K
• Mclaughlin William Robert

Classifications

• G02B6/02057

  comprising gratings · CPC title

• G02B6/02042

  Multicore optical fibres · CPC title

• A61B2562/0266

  Optical strain gauges · CPC title

• A61B5/066

  Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging · CPC title

• A61B5/308

  for electrocardiography [ECG] · CPC title