IP Library › Granted Patent US 12,232,818
Granted Patent B2
US 12,232,818 · App. 17/191,551 · Granted Feb 25, 2025

System and method for optic shape sensing and electrical signal conduction

Inventors: Steffan Sowards (Salt Lake City, UT); Anthony K. Misener (Bountiful, UT)
Assignee: Bard Access Systems, Inc.
A61B34/20A61B5/065A61B5/318G02B6/02042G02B6/02057A61B2034/2061A61B2562/0266G02B2006/12138G02B6/4293
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Quick Facts
Patent No.
US 12,232,818
App. No.
17/191,551
Granted
Feb 25, 2025
Kind
B2
Abstract

A medical device operating as a stylet is described. The medical device can include an insulating layer (or sheath) encapsulating both a multi-core optical fiber and a conductive medium. The optical fiber can include a cladding and a plurality of core fibers spatially arranged within the cladding. Each of the core fibers can include a plurality of sensors distributed along a longitudinal length of that corresponding core fiber and each of these sensors can be 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 for use in determining a physical state of the multi-core optical fiber. The conductive medium can provide a pathway for electrical signals detected at a distal portion of the conductive medium. The conductive medium may be concentric to the cladding, but separate and adjust thereto.

Claims (65)

1. A medical device, comprising:

a multi-core optical fiber including a cladding and one or more core fibers spatially arranged within the cladding, each core fiber of the one or more core fibers including a plurality of sensors distributed along a longitudinal length thereof and each sensor of the plurality of sensors being configured to:

(i) reflect a light signal as reflected light with a different spectral width based on received incident light, and

(ii) change a characteristic of the reflected light for use in determining a physical state of the multi-core optical fiber;

a conductive medium configured to provide a pathway for electrical signals detected at a distal portion of the conductive medium; and

an insulating layer, wherein the multi-core optical fiber is encapsulated in the insulating layer and the conductive medium is encapsulated within the insulating layer.

2. A medical device, comprising:

a multi-core optical fiber including a cladding and one or more core fibers spatially arranged within the cladding, each core fiber of the one or more core fibers including a plurality of sensors distributed along a longitudinal length of each core fiber and each sensor of the plurality of sensors being configured to:

(i) reflect a light signal as reflected light with a different spectral width based on received incident light, and

(ii) change a characteristic of the reflected light for use in determining a physical state of the multi-core optical fiber; and

a conductive medium configured to provide a pathway for electrical signals detected at a distal portion of the conductive medium, wherein the conductive medium includes one or more channels along a surface of the conductive medium, and wherein each channel of the one or more channels is configured to retain at least one core fiber of the one or more core fibers.

3. The medical device as defined in claim 1 , wherein the medical device corresponds to a multimodal stylet.

4. The medical device as defined in claim 1 , wherein each sensor of the plurality of sensors constitutes a reflective grating positioned at a different region along the longitudinal length of each core fiber.

5. The medical device as defined in claim 1 , wherein the change in the characteristic of the reflected light includes a shift in wavelength applied to the reflected light to identify at least a type of strain.

6. The medical device as defined in claim 5 , wherein the type of strain is a compression or a tension.

7. The medical device as defined in claim 1 , wherein the electrical signals include an electrocardiogram (ECG) signal.

8. The medical device as defined in claim 1 , wherein the conductive medium corresponds to a braided tubing positioned concentric to the cladding of the multi-core optical fiber.

9. The medical device as defined in claim 8 , wherein a distal end of the braided tubing and distal ends of each core fiber of the one or more core fibers are exposed at a distal end of the medical device.

10. The medical device as defined in claim 9 , further comprising:

a conductive material positioned at least at the distal end of the braided tubing and positioned to electrically couple the distal end of the braided tubing to an electrical termination point positioned at a proximal end of the medical device.

11. The medical device as defined in claim 1 , wherein the conductive medium corresponds to a conductive tubing positioned concentric to the cladding of the multi-core optical fiber.

12. The medical device as defined in claim 11 , wherein the conductive tubing is nitinol tubing.

13. The medical device as defined in claim 11 , wherein the conductive tubing is not encapsulated in the insulating layer.

14. The medical device as defined in claim 1 , wherein the conductive medium includes one or more electrical wires positioned within a first insulating-layer lumen formed by the insulating layer while the cladding of the multi-core optical fiber is positioned within a second insulating-layer lumen formed by the insulating layer.

15. The medical device as defined in claim 14 , wherein the one or more electrical wires and the multi-core optical fiber are electrically isolated by a portion of the first insulating-layer lumen, a portion of the second insulating-layer lumen, or portions of the first insulating-layer lumen and the second insulating-layer lumen.

16. The medical device as defined in claim 1 , wherein the conductive medium includes a flexible circuit residing along an outer surface of the cladding and distributed along a length of the multi-core optical fiber.

17. The medical device as defined in claim 1 , wherein the one or more core fibers comprise a central core fiber residing within a central cladding lumen formed along a first axis and two or more core fibers each residing within two or more respective cladding lumens formed within a different area of the cladding parallel to the first axis.

18. The medical device as defined in claim 17 , wherein the first axis is a central axis for the multi-core optical fiber having a circular cross-sectional area with the two or more core fibers including:

a first core fiber residing within a first cladding lumen positioned within a first arc segment of the circular cross-sectional area in a first radial direction from the central cladding lumen,

a second core fiber residing within a second cladding lumen positioned within a second arc segment of the circular cross-sectional area separate from the first arc segment in a second radial direction from the first cladding lumen, and

a third core fiber residing within a third cladding lumen positioned within a third arc segment of the circular cross-sectional area separate from both the first arc segment and the second arc segment in a third radial direction from the first cladding lumen.

19. The medical device as defined in claim 1 , wherein the one or more core fibers comprise a central core fiber residing within a central cladding lumen formed along a central axis of the cladding and each core fiber of two or more core fibers residing within a lumen parallel to the central axis such that each core fiber is radially positioned closer to an edge of the cladding than the central core fiber.

20. The medical device as defined in claim 19 , wherein the two or more core fibers include a first core fiber residing within a first cladding lumen formed coplanar to the central cladding lumen, a second core fiber residing within a second cladding lumen positioned radially from the central cladding lumen forming a first obtuse angle between the first cladding lumen and the second cladding lumen, and a third core fiber residing within a third cladding lumen positioned radially from the central cladding lumen forming a second obtuse angle between the first cladding lumen and the third cladding lumen and a third obtuse angle between the second cladding lumen and the third cladding lumen.

21. The medical device as defined in claim 1 , wherein the physical state of the multi-core optical fiber includes one or more of a length, a shape, a form, or an orientation as instantly possessed by the multi-core optical fiber or a portion of the multi-core optical fiber.

22. The medical device as defined in claim 21 , wherein the physical state of the multi-core optical fiber being implemented within a stylet represents an instant physical state of a catheter into which the stylet is inserted during advancement of the catheter into a body of a patient.

23. The medical device as defined in claim 1 , wherein the multi-core optical fiber is positioned to reside within a channel of the conductive medium.

24. The medical device as defined in claim 23 , wherein the conductive medium is an electrical wire including a groove along a surface of the electrical wire to form the channel.

25. The medical device as defined in claim 1 , wherein the conductive medium includes one or more channels along a surface of the conductive medium, and wherein each channel of the one or more channels is configured to retain at least one core fiber of the one or more core fibers.

26. A medical device, comprising:

a multi-core optical fiber including a cladding and one or more core fibers spatially arranged within the cladding, each core fiber of the one or more core fibers including a plurality of sensors distributed along a longitudinal length of each core fiber and each sensor of the plurality of sensors being configured to:

(i) reflect a light signal as reflected light with a different spectral width based on received incident light, and

(ii) change a characteristic of the reflected light for use in determining a physical state of the multi-core optical fiber; and

a conductive medium configured to provide a pathway for electrical signals detected at a distal portion of the conductive medium, the conductive medium comprising a braided tubing positioned concentric to the cladding of the multi-core optical fiber, wherein a distal end of the braided tubing and a distal end of each core fiber of the one or more core fibers are exposed at a distal end of the medical device.

27. The medical device as defined in claim 26 , further comprising a conductive material positioned at least at the distal end of the braided tubing and positioned to electrically couple the distal end of the braided tubing to an electrical termination point positioned at a proximal end of the medical device.

28. A medical device, comprising:

a multi-core optical fiber including a cladding and one or more core fibers spatially arranged within the cladding, the one or more core fibers comprising a central core fiber residing within a central cladding lumen formed along a first axis and two or more core fibers each residing within two or more respective cladding lumens formed within a different area of the cladding parallel to the first axis, each core fiber of the one or more core fibers including a plurality of sensors distributed along a longitudinal length of each core fiber and each sensor of the plurality of sensors being configured to:

(i) reflect a light signal as reflected light with a different spectral width based on received incident light, and

(ii) change a characteristic of the reflected light for use in determining a physical state of the multi-core optical fiber; and

a conductive medium configured to provide a pathway for electrical signals detected at a distal portion of the conductive medium.

29. The medical device as defined in claim 28 , wherein the first axis is a central axis for the multi-core optical fiber having a circular cross-sectional area with the two or more core fibers including:

a first core fiber residing within a first cladding lumen positioned within a first arc segment of the circular cross-sectional area in a first radial direction from the central cladding lumen,

a second core fiber residing within a second cladding lumen positioned within a second arc segment of the circular cross-sectional area separate from the first arc segment in a second radial direction from the first cladding lumen, and

a third core fiber residing within a third cladding lumen positioned within a third arc segment of the circular cross-sectional area separate from both the first arc segment and the second arc segment in a third radial direction from the first cladding lumen.

30. A medical device, comprising:

a multi-core optical fiber including a cladding and one or more core fibers spatially arranged within the cladding, the one or more core fibers comprising a central core fiber residing within a central cladding lumen formed along a central axis of the cladding and each core fiber of two or more core fibers residing within a lumen parallel to the central axis such that each core fiber is radially positioned closer to an edge of the cladding than the central core fiber, each core fiber of the one or more core fibers including a plurality of sensors distributed along a longitudinal length of each core fiber and each sensor of the plurality of sensors being configured to:

(i) reflect a light signal as reflected light with a different spectral width based on received incident light, and

(ii) change a characteristic of the reflected light for use in determining a physical state of the multi-core optical fiber; and

a conductive medium configured to provide a pathway for electrical signals detected at a distal portion of the conductive medium.

31. The medical device as defined in claim 30 , wherein the two or more core fibers include a first core fiber residing within a first cladding lumen formed coplanar to the central cladding lumen, a second core fiber residing within a second cladding lumen positioned radially from the central cladding lumen forming a first obtuse angle between the first cladding lumen and the second cladding lumen, and a third core fiber residing within a third cladding lumen positioned radially from the central cladding lumen forming a second obtuse angle between the first cladding lumen and the third cladding lumen and a third obtuse angle between the second cladding lumen and the third cladding lumen.

32. A medical device, comprising:

a multi-core optical fiber including a cladding and one or more core fibers spatially arranged within the cladding, each core fiber of the one or more core fibers including a plurality of sensors distributed along a longitudinal length thereof and each sensor of the plurality of sensors being configured to:

(i) reflect a light signal as reflected light with a different spectral width based on received incident light, and

(ii) change a characteristic of the reflected light for use in determining a physical state of the multi-core optical fiber; and

a conductive medium configured to provide a pathway for electrical signals detected at a distal portion of the conductive medium, wherein the multi-core optical fiber is positioned to reside within a channel of the conductive medium.

33. The medical device as defined in claim 32 , wherein the conductive medium is an electrical wire including a groove along a surface of the electrical wire to form the channel.

Continuity (2)
Provisional Application 62984552 · Mar 3, 2020
Related Publication 20210275256A1 · Sep 9, 2021
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