# US 11,998,338 B2 · Systems and methods for dynamically switching output port cathode and anode designations

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- Number: US 11,998,338 B2
- Document ID: US11998338B2
- Status: Granted
- Kind: B2
- Application number: 17/575,828
- Filed: 2022-01-14
- Published: 2022-06-30
- Granted: 2024-06-04
- Earliest claimed: 2018-05-04
- Applicants: Cadwell Laboratories, Inc.
- Inventors: Rose Rehfeldt; Ivan Amaya; John A. Cadwell; John A. Cadwell, Jr.
- Web page: https://patentgrep.com/patent/US11998338B2

## CPC

- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61B 5/4893: {Nerves}
- A61B 2505/05: Surgical care
- A61N 1/3603: {Control systems}
- 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

The present specification discloses an intraoperative neurophysiological monitoring (IONM) system including a computing device capable of executing an IONM software engine, a stimulation module having multiple ports and various stimulation components and recording electrodes. The system is used to implement transcranial electrical stimulation and motor evoked potential monitoring by positioning at least one recording electrode on a patient, connecting the stimulation components to at least one port on the stimulation module, positioning the stimulation components on a patient's head, activating, using the IONM software engine, at least one port, delivering stimulation to the patient; and recording a stimulatory response on the patient.

## Claims

### Claim 1

A stimulation module configured to generate and deliver an electrical stimulus comprising at least two successive stimulation pulses, the stimulation module comprising:
a plurality of output ports adapted to connect to a plurality of stimulation electrodes; and
a controller, wherein the controller is configured (i) to designate a first portion of the plurality of output ports to be an anode and to designate a second portion of the plurality of output ports to be a cathode for a first of the at least two successive stimulation pulses and (ii) to change a designation of a third portion of the plurality of output ports to be a cathode and to change a designation of a fourth portion of the plurality of output ports to be an anode for a second of the at least two successive stimulation pulses, wherein the plurality of output ports in the third portion is different than the plurality of output ports in the first portion and wherein the plurality of output ports in the fourth portion is different than the plurality of output ports in the second portion.

### Claim 2 (depends on 1)

The stimulation module of claim 1, further comprising an impedance circuit comprising an impedance voltage generator, an impedance pulse generator, and an impedance sense circuit, wherein the impedance circuit is configured to measure an impedance of the plurality of stimulation electrodes.

### Claim 3 (depends on 1)

The stimulation module of claim 1, further comprising an adjustable voltage converter, wherein the adjustable voltage converter is configured to adjust a voltage to raise or lower an output supply voltage of the stimulation module.

### Claim 4 (depends on 3)

The stimulation module of claim 3, wherein the adjustable voltage converter is a DC to DC voltage converter and is configured to convert said voltage and wherein said voltage is in a range of 200 to 1200 volts.

### Claim 5 (depends on 4)

The stimulation module of claim 4, wherein the adjustable voltage converter comprises a digital-to-analog converter and wherein the digital-to-analog converter is configured to vary a voltage in a feedback loop of the DC-DC voltage converter thereby causing a DC-DC controller to adjust a switching duty cycle to raise or lower the output supply voltage.

### Claim 6 (depends on 1)

The stimulation module of claim 1, wherein the stimulation module is operably connected to a computing device of an intraoperative neurophysiological monitoring (IONM) system and wherein the controller comprises an IONM software engine adapted to execute in the computing device.

### Claim 7 (depends on 1)

The stimulation module of claim 1, wherein the plurality of outputs ports comprise at least nine output ports.

### Claim 8 (depends on 1)

The stimulation module of claim 1, further comprising a constant voltage source, wherein the constant voltage source generates an output voltage of the stimulation module using an emitter follower field-effect transistor.

### Claim 9 (depends on 8)

The stimulation module of claim 8, further comprising a digital-to-analog converter, wherein the digital-to-analog converter is adapted to set a gate voltage of the emitter follower field-effect transistor and wherein the output voltage is proportional to the digital-to-analog converter voltage.

### Claim 10 (depends on 1)

The stimulation module of claim 1, further comprising a pulse generator, wherein the pulse generator comprises:
a current sink adapted to enable a setting of an intensity of an output current of the stimulation module, wherein the current sink comprises at least one digital-to-analog converter and an amplifier adapted to control separate phases of each of the at least two successive pulses;
a second digital-to-analog converter adapted to generate voltage for the current sink that is proportional to the set output current intensity;
trigger logic adapted to enable the stimulation module to switch between a plurality of current intensities; and
a current sense circuit to measure delivered current.

### Claim 11 (depends on 10)

The stimulation module of claim 10, wherein the output current is set by a voltage of the at least one digital-to-analog converter.

### Claim 12 (depends on 11)

The stimulation module of claim 11, wherein the setting of the output current is adapted to force a voltage across a ground referenced transistor at an output.

### Claim 13 (depends on 10)

The stimulation module of claim 10, wherein the pulse generator comprises a field-effect transistor and an amplifier, wherein the pulse generator is adapted to limit and sense an impedance current.

### Claim 14 (depends on 1)

The stimulation module of claim 1, wherein the plurality of output ports are configured to be controlled by a gate drive optocoupler and an H-Bridge transformer driver.

### Claim 15 (depends on 1)

The stimulation module of claim 1, wherein the controller is configured to monitor voltage values on a first side and a second side of a voltage rail, wherein the controller is configured to monitor a value of current, and wherein the controller is configured to output a measurement of one of the at least two successive stimulation pulses based upon the monitored voltage values and the monitored current value.

### Claim 16 (depends on 15)

The stimulation module of claim 15, wherein the controller is adapted to use the monitored voltage values and the monitored current value to compute an impedance value.

### Claim 17 (depends on 1)

The stimulation module of claim 1, wherein the stimulation module is configured to be in time synchronization with a plurality of facilitation stimulators and a plurality of recording electrodes and wherein the plurality of facilitation stimulators and the plurality of recording electrodes are in data communication with a computing device of an intraoperative neurophysiological monitoring (IONM) system.

### Claim 18 (depends on 17)

The stimulation module of claim 17, further comprising a digital timing signal, wherein the time synchronization is achieved using said digital timing signal.

### Claim 19 (depends on 1)

The stimulation module of claim 1, wherein each of the at least two successive stimulation pulses is polyphasic.

### Claim 20 (depends on 1)

The stimulation module of claim 1, further comprising:
a voltage source adapted to enable a setting of an intensity of an output voltage of the stimulation module;
an adjustable voltage converter, wherein the adjustable voltage converter is configured to raise or lower the output voltage of the stimulation module; and
a pulse generator comprising:
a current sink adapted to enable a setting of an intensity of an output current of the stimulation module;
a digital-to-analog converter adapted to generate voltage for the current sink that is proportional to the set output current intensity;
trigger logic adapted to enable the stimulation module to switch between a plurality of current intensities; and
a current circuit to measure delivered current.
