# US 2016/0354035 A1 · Method and apparatus for determining the proximity of a tms coil to a subject's head

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- Number: US 2016/0354035 A1
- Document ID: US20160354035A1
- Status: Published application
- Kind: A1
- Application number: 15/243,671
- Filed: 2016-08-22
- Published: 2016-12-08
- Earliest claimed: 2004-04-15
- Assignees: Neuronetics, Inc.
- Applicants: Neuronetics, Inc.
- Inventors: Mark Edward Reihl; Kenneth Marc Ghiron; Stanford W. Miller
- Web page: https://patentgrep.com/patent/US20160354035A1

## CPC

- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61B 5/05: Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24)
- A61B 5/6835: {Supports or holders, e.g., articulated arms}
- A61B 5/684: {Indicating the position of the sensor on the body}
- A61B 5/6843: {Monitoring or controlling sensor contact pressure}
- A61B 5/6844: {Monitoring or controlling distance between sensor and tissue}
- A61N 2/02: using magnetic fields produced by coils, including single turn loops or electromagnets (A61N2/12 takes precedence)
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2562/0257: Proximity sensors
- A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A proximity sensor for a transcranial magnetic stimulation (TMS) system detects the proximity of a TMS coil assembly to a position at which the coil is to receive pulses during TMS treatment and provides feedback to the operator so that the operator may adjust the TMS coil assembly to maintain optimal positioning during treatment. A flexible substrate containing a sensor or sensor array is disposed between the TMS coil assembly and the position such that the coupling of the TMS coil assembly to the position may be detected by the sensor(s). Sensor outputs are processed by signal processing circuitry to provide an indication of whether the TMS coil assembly is properly disposed with respect to the position during TMS treatment. A display provides an indication of how to adjust the TMS coil assembly to improve the positioning of the TMS coil assembly.

## Claims

### Claim at position 1

1-44. (canceled)

### Claim 45

A magnetic stimulation system comprising:
at least one magnetic stimulation coil assembly comprising at least one magnetic stimulation coil;
a sensor configured to identify locations of a plurality of contact areas on the at least one magnetic stimulation coil assembly that are in contact with a patient's anatomy such that the contact areas on the magnetic stimulation coil assembly are distinguishable from non-contact areas on the magnetic stimulation coil assembly; and
signal processing circuitry configured to process outputs of said sensor to provide an indication of whether said magnetic stimulation coil assembly is properly disposed based on the locations of the contact areas on the magnetic stimulation coil assembly that are in contact with the patient's anatomy.

### Claim 46 (depends on 45)

The magnetic stimulation system as in claim 45, wherein said sensor comprises at least one sensor disposed in or on a flexible substrate placed between the at least one magnetic stimulation coil and a position at which magnetic stimulation is applied.

### Claim 47 (depends on 45)

The magnetic stimulation system as in claim 45, wherein said at least one sensor comprises variable resistance sensors configured to output an output signal that is proportionate to applied contact pressure, whereby a change in resistance above a predetermined threshold is identified as an indication of contact.

### Claim 48 (depends on 45)

The magnetic stimulation system as in claim 45, wherein the magnetic stimulation system is configure to provide transcranial magnetic stimulation (TMS) treatment.

### Claim 49 (depends on 45)

The magnetic stimulation system as in claim 45, wherein the magnetic stimulation system is configure to provide therapeutic treatment.

### Claim 50 (depends on 45)

The magnetic stimulation system as in claim 45, wherein the magnetic stimulation system is configure to provide diagnoses.

### Claim 51 (depends on 45)

The magnetic stimulation system as in claim 45, wherein the sensor comprises a loop of conducting material placed at a position at which at least one pulse is to be applied to the at least one magnetic stimulation coil, the loop of conducting material having an induced voltage therein when the at least one pulse is applied to the at least one magnetic stimulation coil when the at least one magnetic stimulation coil is in proximity to the loop of conducting material, and wherein whether the induced voltage exceeds a predetermined threshold serves as an indication of whether the at least one magnetic stimulation coil assembly is properly disposed.

### Claim 52 (depends on 45)

The magnetic stimulation system as in claim 45, further comprising:
a pulse generating device configured to apply at least one pulse to the at least one magnetic stimulation coil during magnetic stimulation.

### Claim 53 (depends on 45)

The magnetic stimulation system as in claim 45, wherein the indication comprises an indication of which direction to move said at least one magnetic stimulation coil assembly to properly dispose the at least one magnetic stimulation coil assembly.

### Claim 54 (depends on 45)

The magnetic stimulation system as in claim 45, wherein the indication comprises a pressure map indicating where the at least one magnetic stimulation coil assembly has proper contact with the patient's anatomy and where the at least one magnetic stimulation coil assembly does not have proper contact with the patient's anatomy.

### Claim 55 (depends on 45)

The magnetic stimulation system as in claim 45, wherein said indication is provided to a sound generator that is configured to generate a sound that indicates whether said magnetic stimulation coil assembly is properly disposed.

### Claim 56

A device for detecting the proximity of at least one magnetic stimulation coil assembly to an anatomy of a patient, the device comprising:
a flexible substrate disposed between said at least one magnetic stimulation coil assembly and said anatomy; and
at least one sensor disposed on said substrate between the at least one magnetic stimulation coil assembly and said anatomy, the sensor being configured to identify locations of a plurality of contact areas on the at least one magnetic stimulation coil assembly that are in contact with a patient's anatomy such that the contact areas on the magnetic stimulation coil assembly are distinguishable from non-contact areas on the at least one magnetic stimulation coil assembly.

### Claim 57 (depends on 56)

The device as in claim 56, processing circuitry configured to process outputs of said at least one sensor for determining whether said magnetic stimulation coil assembly is properly disposed based on the locations of the contact areas on the magnetic stimulation coil assembly that are in contact with the patient's anatomy.

### Claim 58 (depends on 56)

The device as in claim 56, wherein said at least one sensor comprises variable resistance sensors configured to provide an output signal that is proportionate to applied contact pressure, whereby a change in resistance above a predetermined threshold is identified as an indication of contact.

### Claim 59 (depends on 56)

The device as in claim 56, wherein the at least one sensor comprises membrane switches that change state when depressed, each membrane switch comprising respective conductive films separated by a dielectric layer.

### Claim 60

A method of providing magnetic stimulation to a patient, the method comprising:
identifying locations of a plurality of contact areas on at least one magnetic stimulation coil assembly that are in contact with the patient's anatomy;
identifying locations of a plurality of non-contact areas on the at least one magnetic stimulation coil assembly that are not in contact with the patient; and
providing an indication of whether the at least one magnetic stimulation coil assembly is properly positioned based on the locations of the contact areas on the magnetic stimulation coil assembly that are in contact with the patient's anatomy.

### Claim 61 (depends on 60)

The method of claim 60, wherein the magnetic stimulation coil assembly comprising at least one magnetic stimulation coil, the method further comprising determining whether the at least one magnetic stimulation coil assembly is properly positioned by comparing the locations to a position at which magnetic stimulation is to be applied to the at least one magnetic stimulation coil assembly.

### Claim 62 (depends on 60)

The method as in claim 60, wherein the magnetic stimulation coil assembly comprises at least one magnetic stimulation coil, the method further comprising:
applying at least one pulse to the at least one magnetic stimulation coil.

### Claim 63 (depends on 60)

The method as in claim 60, wherein the magnetic stimulation coil assembly comprises at least one magnetic stimulation coil, the method further comprising:
disposing a sensor between said at least one magnetic stimulation coil assembly and the patient's anatomy.

### Claim 64 (depends on 60)

The method as in claim 60, wherein the magnetic stimulation coil assembly comprises at least one magnetic stimulation coil, the method further comprising:
disposing a loop of conducting material at a position at which at least one pulse is to be applied to the at least one magnetic stimulation coil, said loop of conducting material having an induced voltage therein when the at least one pulse is applied to said at least one magnetic stimulation coil when said at least one magnetic stimulation coil is in proximity to said loop of conducting material;
applying at least one pulse to said at least one magnetic stimulation coil;
measuring said induced voltage; and
determining whether said induced voltage exceeds a predetermined threshold for indicating whether said at least one magnetic stimulation coil assembly is properly disposed during application of the least one pulse to said at least one magnetic stimulation coil.
