# US 10,765,370 B2 · Systems and methods for neurological traffic and/or receptor functional evaluation and/or modification

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- Number: US 10,765,370 B2
- Document ID: US10765370B2
- Status: Granted
- Kind: B2
- Application number: 15/971,459
- Filed: 2018-05-04
- Published: 2018-09-06
- Granted: 2020-09-08
- Earliest claimed: 2013-03-27
- Assignees: Autonomix Medical, Inc.
- Applicants: Autonomix Medical, Inc.
- Inventors: Landy Toth; Robert Schwartz
- Web page: https://patentgrep.com/patent/US10765370B2

## CPC

- A61B 5/6851: {Guide wires}
- A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/4041: {Evaluating nerves condition}
- A61B 5/4875: {Hydration status, fluid retention of the body}
- A61B 5/685: {Microneedles}
- A61B 5/6852: {Catheters}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/36139: {with automatic adjustment}
- A61B 5/201: {Assessing renal or kidney functions}
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/0022: {Balloons}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00511: {Kidney}
- A61B 2018/00577: {Ablation}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/0088: {Vibration}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Systems and methods for controlled sympathectomy procedures for neuromodulation are disclosed. A system for controlled micro ablation procedures is disclosed. A guidewire including one or more sensors or electrodes for accessing and recording physiologic information from one or more anatomical sites within the parenchyma of an organ as part of a physiologic monitoring session, a diagnostic test, or a neuromodulation procedure is disclosed. A guidewire including one or more sensors and/or a means for energy delivery, for performing a neuromodulation procedure within a small vessel within a body is disclosed.

## Claims

### Claim 1

A guidewire, comprising:
an elongate body dimensioned for insertion into a lumen within a body; and
a sensing tip electrically and mechanically coupled to the elongate body, the sensing tip being configured to interface with the wall of the lumen and to convey one or more electrophysiological signals associated with an electrophysiological activity in the vicinity of an anatomical site of interest within the vicinity of the lumen;
wherein the sensing tip comprises:
a flexible substrate comprising a base portion and two or more tines extending from the base portion;
a plurality of electrodes disposed on each of the two or more tines extending from the base portion of the flexible substrate; and
one or more microcircuits disposed on the base portion of the flexible substrate, the one or more microcircuits being coupled to (i) the plurality of electrodes disposed on the two or more tines extending from the base portion of the flexible substrate and (ii) one or more lead wires.

### Claim 2 (depends on 1)

The guidewire of claim 1, wherein at least a subset of the plurality of electrodes are arranged along at least one of the two or more tines with a predetermined spacing.

### Claim 3 (depends on 1)

The guidewire of claim 1, wherein at least one of the two or more tines has a width that is tapered along the length of the at least one tine.

### Claim 4 (depends on 1)

The guidewire of claim 1, wherein the sensing tip further comprises one or more traces disposed on the two or more tines interconnecting the plurality of electrodes with the one or more microcircuits.

### Claim 5 (depends on 1)

The guidewire of claim 1, wherein the flexible substrate comprises a laminate composite structure.

### Claim 6 (depends on 5)

The guidewire of claim 5, wherein the laminate composite structure comprises a base substrate, one or more traces disposed on the base substrate interconnecting the plurality of electrodes with the one or more microcircuits, and one or more overcoats disposed over the one or more traces and the base substrate.

### Claim 7 (depends on 1)

The guidewire of claim 1, wherein at least a subset of the plurality of electrodes are configured to extend above a height of the flexible substrate.

### Claim 8 (depends on 7)

The guidewire of claim 7, wherein the subset of the plurality of electrodes are formed as bumps disposed on a surface of the one or more tines of the flexible substrate.

### Claim 9 (depends on 7)

The guidewire of claim 7, wherein the subset of the plurality of electrodes comprise whisker features that extend above the height of the substrate.

### Claim 10 (depends on 7)

The guidewire of claim 7, wherein the subset of the plurality of electrodes are plated to extend above the height of the substrate.

### Claim 11 (depends on 1)

The guidewire of claim 1, wherein the two or more tines extending from the base portion of the flexible are shaped to form a tine envelope.

### Claim 12 (depends on 11)

The guidewire of claim 11, wherein at least a subset of the plurality of electrodes are disposed on the two or more tines of the tine envelope and the one or more microcircuits are located at a root of the tine envelope.

### Claim 13 (depends on 12)

The guidewire of claim 12, wherein the subset of the plurality of electrodes are positioned on the two or more tines of the tine envelope such that, when the tine envelope is rolled, the subset of the plurality of electrodes interface with different positions of an elongate span of the lumen into which the guidewire is placed.

### Claim 14 (depends on 13)

The guidewire of claim 13, further comprising at least one of a jacket and a coil disposed surrounding at least a portion of the rolled tine envelope.

### Claim 15 (depends on 1)

The guidewire of claim 1, further comprising one or more stabilizing anchors coupled to the elongate body, the one or more stabilizing anchors being configured to deploy from the elongate body and couple to at least a first lumen proximate the anatomical site of interest.

### Claim 16 (depends on 15)

The guidewire of claim 15, wherein the sensing tip is configured to deploy from the elongate body to interface with a wall of a second lumen.

### Claim 17 (depends on 16)

The guidewire of claim 16, wherein the first lumen and the second lumen are the same.

### Claim 18 (depends on 16)

The guidewire of claim 16, wherein the sensing tip comprises an insulating layer configured to isolate one or more portions of the sensing tip from its surroundings.

### Claim 19 (depends on 18)

The guidewire of claim 18, wherein the insulating layer has a varying thickness to form one or more step transitions along a length of the sensing tip, the one or more step transitions limiting a depth of penetration of the sensing tip into the wall of the second lumen.

### Claim 20 (depends on 15)

The guidewire of claim 15, wherein the one or more stabilizing anchors are shaped to bias against a wall of the first lumen on deployment from the elongate body.

### Claim 21 (depends on 1)

The guidewire of claim 1, wherein a given one of the lead wires is coupled with power management hardware configured to provide both power and signal communication on the given lead wire.
