IP Library › Granted Patent US 12,440,165
Granted Patent B2
US 12,440,165 · App. 17/815,657 · Granted Oct 14, 2025

Catheter for neural measurements and treatment and related systems and methods

Inventors: Michael L. Reo (Redwood City, CA); Stephen Bower (Morgan Hill, CA); Ashby Shaw (Santa Clara, CA); David Elliot Faulk, Jr. (San Jose, CA)
Assignee: Otsuka Medical Devices Co., Ltd.
A61B5/6852A61B5/294A61B5/388A61B2562/0209A61B2562/222A61B2562/227A61M25/0054A61M2025/0096A61M2205/0266
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Quick Facts
Patent No.
US 12,440,165
App. No.
17/815,657
Granted
Oct 14, 2025
Kind
B2
Abstract

Described herein are catheters for use in analyzing neural activity of nerves that surround a biological lumen. Such a catheter comprises a handle including a first, second, and third actuators, and a shaft extending from the handle and including proximal and distal electrodes that are selectively deployable. The first actuator is configured to selectively deploy the proximal electrode in response to the first actuator being manually maneuvered. The second actuator is configured to selectively deploy the distal electrode in response to the second actuator being manually maneuvered. The third actuator is configured to selectively adjust a longitudinal distance between the proximal and distal electrodes in response to the third actuator being manually maneuvered.

Claims (88)

1. A catheter for use in analyzing neural activity of nerves that surround a biological lumen, the catheter comprising:

a handle including first, second, and third actuators; and

a shaft extending from the handle and including proximal and distal electrodes that are selectively deployable;

the first actuator configured to selectively deploy the proximal electrode in response to the first actuator being manually maneuvered;

the second actuator configured to selectively deploy the distal electrode in response to the second actuator being manually maneuvered; and

the third actuator configured to selectively adjust a longitudinal distance between the proximal and distal electrodes in response to the third actuator being manually maneuvered; wherein: the shaft also includes a plurality of nested and concentric tubes; one of the tubes is mechanically coupled between the first actuator and the proximal electrode that is selectively deployable such that the one of the tubes and the first actuator are collectively configured to deploy the proximal electrode in response to the first actuator being manually maneuvered; another one of the tubes is mechanically coupled between the second actuator and the distal electrode that is selectively deployable such that the another one of the tubes and the second actuator are collectively configured to deploy the distal electrode in response to the second actuator being manually maneuvered; and a further one of the tubes is mechanically coupled to the third actuator such that the further one of the tubes and the third actuator are collectively configured to adjust a longitudinal distance between the proximal and distal electrodes, while one of the proximal and distal electrodes is deployed, in response to the third actuator being manually maneuvered.

2. The catheter of claim 1 , wherein the third actuator:

is configured to selectively adjust the longitudinal distance between the proximal and distal electrodes, while a first one of the proximal and distal electrodes is deployed, in response to the third actuator being manually maneuvered; and

is locked in place, thereby preventing the longitudinal distance between the proximal and distal electrodes from being adjusted, while a second one of the proximal and distal electrodes is deployed.

3. The catheter of claim 1 , wherein:

each electrode, of the proximal and distal electrodes that are selectively deployable, includes a pair of longitudinal ends, and is configured to be selectively deployed in response to one of the longitudinal ends being moved towards the other one of the longitudinal ends of the electrode.

4. The catheter of claim 1 , wherein:

each electrode, of the proximal and distal electrodes that are selectively deployable, comprises a nitinol tube having a laser cut pattern of apertures that separate struts of the electrode.

5. The catheter of claim 1 , wherein:

the plurality of nested and concentric tubes include first, second, third, and fourth tubes;

a portion of each of the second, third, and fourth tubes extends through a hollow lumen of the proximal electrode; and

a portion of the fourth tube extends through a hollow lumen of the distal electrode.

6. The catheter of claim 5 , wherein:

at least a portion of the fourth tube extends through at least a portion of each of the first, second, and third tubes;

at least a portion of the third tube extends through at least a portion of the first and second tubes;

at least a portion of the second tube extends through at least a portion of the first tube;

a longitudinal length of the fourth tube is greater than a longitudinal length of the third tube;

the longitudinal length of the third tube is greater than a longitudinal length of the second tube; and

the longitudinal length of the second tube is great then a longitudinal length of the first tube.

7. The catheter of claim 5 , wherein:

each of the first, second, third, and fourth tubes includes a respective inner diameter and a respective outer diameter;

the outer diameter of the fourth tube is less than the inner diameter of the third tube;

the outer diameter of the third tube is less than the inner diameter of the second tube; and

the outer diameter of the second tube is less than the inner diameter of the first tube.

8. The catheter of claim 5 , wherein:

a distal portion of each of the second, third, and fourth tubes includes a respective flange that has an outer diameter that is substantially the same as the outer diameter of the first tube.

9. The catheter of claim 1 , further comprising:

an electrical cable that extends from the handle and is configured to electrically connect the catheter to an electronic control unit (ECU);

each tube, of at least two of the plurality of tubes, includes an electrically conductive coil extending between proximal and distal ends of the tube and surrounded by one or more electrical insulator;

the electrically conductive coil of one of the tubes is electrically coupled between the proximal electrode and an electrically conductive path within the handle to thereby provide for an electrical connection between the proximal electrode and the electrical cable that extends from the handle; and

the electrically conductive coil of another one of the tubes is electrically coupled between the distal electrode and another electrically conductive path within the handle to thereby provide for an electrical connection between the distal electrode and the electrical cable that extends from the handle.

10. The catheter of claim 9 , wherein the electrically conductive coil of each tube that includes an electrically conductive coil:

is sandwiched between a hollow sleeve of electrically non-conductive material and an outer jacket of electrically non-conductive material; and

provides for kink resistance and crush resistance, as well as providing an electrically conductive path along a length of the tube without requiring that a wire be threaded through a hollow lumen of the tube.

11. The catheter of claim 1 , further comprising:

a transducer physically coupled to one of the plurality of tubes and configured to emit a neuromodulation signal in response to a voltage being applied between first and second electrodes of the transducer;

wherein the one of the plurality of tubes, to which the transducer is physically coupled, includes first and second electrically conductive coils extending between proximal and distal ends of the one of the plurality of tubes; and

wherein the first and second electrically conductive coils are electrically coupled, respectively, to the first and second electrodes of the transducer to thereby enable the voltage to be applied between the first and second electrodes of the transducer.

12. A catheter for use in analyzing neural activity of nerves that surround a biological lumen, the catheter comprising:

a handle including a plurality of actuators; and

a shaft extending from the handle and including a plurality of nested and concentric tubes, and also including proximal and distal electrodes that are selectively deployable;

each electrode, of the proximal and distal electrodes that are selectively deployable, including a pair of longitudinal ends and configured to be selectively deployed in response to one of the longitudinal ends being moved towards the other one of the longitudinal ends of the electrode;

one of the tubes mechanically coupled between one of the actuators and the proximal electrode that is selectively deployable such that the one of the tubes and the one of the actuators are collectively configured to deploy the proximal electrode in response to the one of the actuators being manually maneuvered;

another one of the tubes mechanically coupled between another one of the actuators and the distal electrode that is selectively deployable such that the another one of the tubes and the another one of the actuators are collectively configured to deploy the distal electrode in response to the another one of the actuators being manually maneuvered; and

a further one of the tubes mechanically coupled to a further one of the actuators such that the further one of the tubes and the further one of the actuators are collectively configured to adjust a longitudinal distance between the proximal and distal electrodes, while one of the proximal and distal electrodes is deployed, in response to the further one of the actuators being manually maneuvered.

13. The catheter of claim 12 , wherein:

the actuators are configured such that while a specific one of the proximal and distal electrodes is deployed, the one of the actuators, which is configured to adjust the longitudinal distance between the proximal and distal electrodes, is locked in place to thereby prevent adjustment to the longitudinal distance between the proximal and distal electrodes while the specific one of the proximal and distal electrodes is deployed.

14. The catheter of claim 12 , further comprising an electrical cable that extends from a proximal portion of the handle and is configured to electrically connect the catheter to an electronic control unit (ECU), wherein:

each tube, of at least two of the plurality of tubes, includes an electrically conductive coil extending between proximal and distal ends of the tube and surrounded by one or more electrical insulator;

the electrically conductive coil of one of the tubes is electrically coupled between the proximal electrode and an electrically conductive path within the handle to thereby provide for an electrical connection between the proximal electrode and the electrical cable that extends from the proximal portion of the handle; and

the electrically conductive coil of another one of the tubes is electrically coupled between the distal electrode and another electrically conductive path within the handle to thereby provide for an electrical connection between the distal electrode and the electrical cable that extends from the proximal portion of the handle;

wherein the electrically conductive coil of each tube that includes a said electrically conductive coil is sandwiched between a hollow sleeve of electrically non-conductive material and an outer jacket of electrically non-conductive material, and provides for kink resistance and crush resistance, as well as providing an electrically conductive path along a length of the tube without requiring that a wire be threaded through a hollow lumen of the tube.

15. The catheter of claim 12 , wherein:

each electrode, of the proximal and distal electrodes that are selectively deployable, comprises a nitinol tube having a pattern of apertures that separate struts of the electrode.

16. The catheter of claim 12 , wherein:

the plurality of nested and concentric tubes includes first, second, third, and fourth tubes that are concentric and nested such that at least a portion of the fourth tube extends through at least a portion of each of the first, second, and third tubes, at least a portion of the third tube extends through at least a portion of the first and second tubes, and at least a portion of the second tube extends through at least a portion of the first tube; and

a longitudinal length of the fourth tube is greater than a longitudinal length of the third tube, the longitudinal length of the third tube is greater than a longitudinal length of the second tube, and the longitudinal length of the second tube is great then a longitudinal length of the first tube.

17. The catheter of claim 16 , wherein:

each of the first, second, third, and fourth tubes includes a respective inner diameter and a respective outer diameter;

the outer diameter of the fourth tube is less than the inner diameter of the third tube;

the outer diameter of the third tube is less than the inner diameter of the second tube; and

the outer diameter of the second tube is less than the inner diameter of the first tube.

18. The catheter of claim 16 , wherein:

a distal portion of each of the second, third, and fourth tubes includes a respective flange that has an outer diameter that is substantially the same as the outer diameter of the first tube.

19. The catheter of claim 12 , further comprising:

a transducer physically coupled to one of the plurality of tubes and configured to emit a neuromodulation signal in response to a voltage being applied between first and second electrodes of the transducer;

wherein the one of the plurality of tubes, to which the transducer is physically coupled, includes first and second electrically conductive coils extending between proximal and distal ends of the one of the plurality of tubes; and

wherein the first and second electrically conductive coils are electrically coupled, respectively, to the first and second electrodes of the transducer to thereby enable the voltage to be applied between the first and second electrodes of the transducer.

20. A catheter for use in analyzing neural activity of nerves that surround a biological lumen, the catheter comprising:

a handle including a plurality of actuators; and

a shaft extending from the handle and including first, second, third, and fourth tubes that are nested and concentric, and also including proximal and distal electrodes that are selectively deployable;

an electrical cable that extends from a proximal portion of the handle and is configured to by coupled to an electronic control unit;

each electrode, of the proximal and distal electrodes that are selectively deployable, including a pair of longitudinal ends and configured to be selectively deployed in response to one of the longitudinal ends being moved towards the other one of the longitudinal ends of the electrode;

each tube, of at least two of the first, second, third, and fourth tubes, includes an electrically conductive coil extending between proximal and distal ends of the tube and surrounded by one or more electrical insulator;

the electrically conductive coil of one of the tubes is electrically coupled between the proximal electrode and an electrically conductive path within the handle to thereby provide for an electrical connection between the proximal electrode and the electrical cable that extends from the proximal end of the handle; and

the electrically conductive coil of another one of the tubes is electrically coupled between the distal electrode and another electrically conductive path within the handle to thereby provide for an electrical connection between the distal electrode and the electrical cable that extends from the proximal end of the handle; wherein: one of the tubes is mechanically coupled between one of the actuators and the proximal electrode that is selectively deployable such that the one of the tubes and the one of the actuators are collectively configured to deploy the proximal electrode in response to the one of the actuators being manually maneuvered; and another one of the tubes is mechanically coupled between another one of the actuators and the distal electrode that is selectively deployable such that the another one of the tubes and the another one of the actuators are collectively configured to deploy the distal electrode in response to the another one of the actuators being manually maneuvered; wherein: a further one of the tubes is mechanically coupled to a further one of the actuators such that the further one of the tubes and the further one of the actuators are collectively configured to adjust a longitudinal distance between the proximal and distal electrodes, while one of the proximal and distal electrodes is deployed, in response to the further one of the actuators being manually maneuvered.

21. The catheter of claim 20 , further comprising one or more non-deployable ring electrodes on the shaft, each of which is electrically coupled to the electrical cable.

22. The catheter of claim 20 , wherein the electrically conductive coil, of each tube that includes an electrically conductive coil, is sandwiched between a hollow sleeve of electrically non-conductive material and an outer jacket of electrically non-conductive material.

23. The catheter of claim 20 , wherein the electrically conductive coil, of each tube that includes an electrically conductive coil, provides for kink resistance and crush resistance, as well as providing an electrically conductive path along a length of the tube without requiring that a wire be threaded through a hollow lumen of the tube.

24. The catheter of claims 20 , further comprising:

a transducer physically coupled to the third tube and configured to emit a neuromodulation signal in response to a voltage being applied between first and second electrodes of the transducer;

wherein the third tube, to which the transducer is physically coupled, includes first and second electrically conductive coils extending between proximal and distal ends of the third tube; and

wherein the first and second electrically conductive coils are electrically coupled, respectively, to the first and second electrodes of the transducer to thereby enable the voltage to be applied between the first and second electrodes of the transducer.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 2, 2022
From: REO, MICHAEL L.; BOWER, STEPHEN; SHAW, ASHBY; FAULK, DAVID ELLIOTT, JR.
To: OTSUKA MEDICAL DEVICES CO., LTD.
Reel/Frame 060698/0175 →
Continuity (4)
Provisional Application 63357840 · Jul 1, 2022
Provisional Application 63263000 · Oct 25, 2021
Provisional Application 63226622 · Jul 28, 2021
Related Publication 20230040877A1 · Feb 9, 2023
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