Granted Patent B2

US 12,539,176 · App. 17/965,657 · Granted Feb 3, 2026

Inventors: Steffan Sowards (Salt Lake City, UT); William Robert McLaughlin (Bountiful, UT); Anthony K. Misener (Bountiful, UT)

Assignee: Bard Access Systems, Inc.

A61B34/20A61B8/0841A61B8/4254A61B8/4444A61B8/466G01H9/004G01S7/6245G01S15/8993A61B2034/2061A61B2034/2063

Abstract

Claims (75)

1 . A medical system comprising:

an ultrasound imaging probe having a first optical fiber integrated therein, wherein:

the first optical fiber within the ultrasound imaging probe includes a known static reference shape having one or more curves, and

the known static reference shape defines a reference plane that is disposed in a fixed aligned relationship with an image plane of the ultrasound imaging probe;

a first elongate member defining a first proximal end and a first distal end, the first elongate member including a second optical fiber extending along the first elongate member from the first proximal end to the first distal end, and the ultrasound imaging probe coupled with the first elongate member at the first distal end,

wherein the first proximal end is coupled with a system module of the medical system at a defined first endpoint location and the first elongate member extends away from the system module along a defined first direction vector;

a second elongate member defining a second proximal end and a second distal end, the second elongate member including:

a third optical fiber extending along the second elongate member from the second proximal end to the second distal end; and

a medical device coupled with the second elongate member at the second distal end,

wherein the second proximal end is coupled with the system module at a defined second endpoint location and the second elongate member extends away from the system module along a defined second direction vector;

wherein:

the first optical fiber includes one or more first core fibers, each of the one or more first core fibers including a first plurality of sensors distributed along a longitudinal length of the first optical fiber,

the second optical fiber includes one or more second core fibers, each of the one or more second core fibers including a second plurality of sensors distributed along a longitudinal length of the second optical fiber,

the third optical fiber includes one or more third core fibers, each of the one or more third core fibers including a third plurality of sensors distributed along a longitudinal length of the third optical fiber, and

each sensor of the first, second, and third pluralities of sensors is 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 each respective core fiber; and

the system module including a console, wherein:

the first proximal end and the second proximal end are physically coupled with the system module such that the defined first endpoint location and the defined first direction vector are defined with respect to the defined second endpoint location and the defined second direction vector, and

the console is optically coupled with the ultrasound imaging probe via the first elongate member and the medical device via the second elongate member, the console including one or more processors and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations including:

providing the received incident light to the first, second, and third optical fibers;

receiving reflected light signals of different spectral widths of the received incident light from the first, second, and third pluralities of sensors;

processing the reflected light signals received from the first and the second plurality of sensors to determine a first three-dimensional (3D) shape extending along at least portions of the longitudinal length of the first optical fiber and the longitudinal length of the second optical fiber;

determining a positioning of the ultrasound imaging probe based at least on the reflected light signals received from the second plurality of sensors;

processing the reflected light signals received from the third plurality of sensors to determine a second 3D shape extending along at least portions of the longitudinal length of the third optical fiber;

determining a position of the medical device with respect to the ultrasound imaging probe using the first 3D shape, the second 3D shape, the defined first endpoint location, the defined first direction vector, the defined second endpoint location, and the defined second direction vector;

determining an orientation of the reference plane based on the reflected light signals received from the first plurality of sensors; and

causing rendering of an image on a display of the medical system in accordance with the positioning of the ultrasound imaging probe and the reference plane, wherein the image includes at least one of an ultrasound image of a patient or a representation of the patient.

2 . The medical system according to claim 1 , wherein the operations further include:

determining a positioning and an orientation of the second 3D shape with respect to the reference plane thereby determining an orientation of the second elongate member relative to the orientation of the ultrasound imaging probe; and

causing rendering of an image of the second 3D shape within the image on the display of the medical system in accordance with the positioning and the orientation of the second 3D shape.

3 . The medical system according to claim 1 , wherein in use, an orientation of the ultrasound imaging probe is manipulated to adjust an orientation of a viewing reference.

4 . The medical system according to claim 1 , wherein the operations further include causing rendering of a visual indication of a target blood vessel within the image.

5 . The medical system according to claim 1 , wherein the operations further include using known dimensions of both the first elongate member and the second elongate member to determine the position of the medical device with respect to the ultrasound imaging probe.

6 . The medical system according to claim 2 , wherein the operations further include:

receiving the ultrasound image from the ultrasound imaging probe, and

causing rendering of the image of the second 3D shape on the display of the medical system to include a portion of a patient body based on the ultrasound image.

7 . The medical system according to claim 2 , wherein the medical device is an intravascular device including a fourth optical fiber integrated therein, the fourth optical fiber having a fourth plurality of sensors, wherein the fourth optical fiber is configured to receive a third incident light signal and provide fourth reflected light signals to the console, and wherein the operations further include determining the positioning and the orientation of the second 3D shape in the reference plane based at least in part on the fourth reflected light signals.

8 . The medical system according to claim 7 , wherein the intravascular device includes one or more of a catheter, a stylet, a needle, or a guidewire.

9 . A method for detecting placement of a medical device within a patient, the method comprising:

providing an incident light to:

a second optical fiber and a first optical fiber via a first elongate member, the first elongate member defining a first proximal end and a first distal end; and

a third optical fiber via a second elongate member, the second elongate member defining a second proximal end and a second distal end,

wherein:

the first optical fiber is integrated into an ultrasound imaging probe of a medical system, wherein:

the first optical fiber within the ultrasound imaging probe includes a known static reference shape having one or more curves, and

the known static reference shape defines a reference plane that is disposed in a fixed aligned relationship with an image plane of the ultrasound imaging probe;

the second optical fiber extends along the first elongate member from the first proximal end to the first distal end, the first elongate member coupled with the ultrasound imaging probe at the first distal end,

wherein the first proximal end is coupled with a system module of the medical system at a defined first endpoint location and the first elongate member extends away from the system module along a defined first direction vector,

the third optical fiber extends along the second elongate member from the second proximal end of the second elongate member to the second distal end of the second elongate member, the second elongate member coupled with the medical device at the second distal end,

wherein:

the second proximal end is coupled with the system module at a defined second endpoint location and the second elongate member extends away from the system module along a defined second direction vector, and

the first proximal end and the second proximal end are physically coupled with the system module such that the defined first endpoint location and the defined first direction vector are defined with respect to the defined second endpoint location and the defined second direction vector,

the first optical fiber includes one or more first core fibers, the one or more first core fibers including a first plurality of sensors distributed along a longitudinal length of the first optical fiber,

the second optical fiber includes one or more second core fibers, the one or more second core fibers including a second plurality of sensors distributed along a longitudinal length of the second optical fiber,

the third optical fiber includes one or more third core fibers, the one or more third core fibers including a third plurality of sensors distributed along a longitudinal length of the third optical fiber, and

each sensor of the first, second, and third pluralities of sensors is 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 signals based on strain experienced by the first, second, and third optical fibers, respectively;

providing by a console of the medical system the incident light to the first, second, and third optical fibers,

receiving by the console, reflected light signals of different spectral widths of the incident light from the first, second, and third pluralities of sensors;

processing in accordance with logic of the medical system, the reflected light signals to determine;

a first three-dimensional (3D) shape extending along at least portions of the longitudinal length of the first optical fiber and the longitudinal length of the second optical fiber;

a second 3D shape extending along at least a portion of the longitudinal length of the third optical fiber; and

determining a position of the ultrasound imaging probe based on the second 3D shape;

determining an orientation of the reference plane based on the first 3D shape;

determining a position of the medical device with respect to the ultrasound imaging probe using the first 3D shape, the second 3D shape, the defined first endpoint location, the defined first direction vector, the defined second endpoint location, and the defined second direction vector; and

causing rendering of an image on a display of the medical system in accordance with the position of the ultrasound imaging probe and the reference plane, wherein the image includes at least one of an ultrasound image of the patient or a representation of the patient.

10 . The method according to claim 9 , further comprising:

determining a positioning and an orientation of the second 3D shape in the reference plane thereby determining an orientation of the second elongate member relative to the orientation of the ultrasound imaging probe; and

causing rendering of an image of the second 3D shape within the image on the display of the medical system in accordance with the positioning and the orientation of the second 3D shape.

11 . The method according to claim 9 , further comprising causing rendering of a visual indication of a target blood vessel within the image.

12 . The method according to claim 9 , further comprising adjusting an orientation of a viewing reference when in use, wherein an orientation of the ultrasound imaging probe is manipulated.

13 . The method according to claim 9 , further comprising using known dimensions of both the first elongate member and the second elongate member to determine the position of the medical device with respect to the ultrasound imaging probe.

14 . The method according to claim 10 , further comprising:

receiving the ultrasound image from the ultrasound imaging probe, and

causing rendering of the image of the second 3D shape on the display of the medical system to include a portion of a patient body based on the ultrasound image.

15 . The method according to claim 10 , wherein the medical device is an intravascular device including a fourth optical fiber integrated therein, the fourth optical fiber having a fourth plurality of sensors, wherein the fourth optical fiber is configured to receive the incident light and provide fourth reflected light signals to the console, and wherein operations further include determining the positioning and the orientation of the second 3D shape in the reference plane based at least in part on the fourth reflected light signals.

16 . The method according to claim 15 , wherein the intravascular device includes one or more of a catheter, a stylet, a needle, or a guidewire.

Continuity (2)

References Cited (308)