# US 12,119,120 B2 · Optimal multi-electrode transcutaneous stimulation with high focality and intensity

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- Number: US 12,119,120 B2
- Document ID: US12119120B2
- Status: Granted
- Kind: B2
- Application number: 18/332,091
- Filed: 2023-06-09
- Published: 2023-12-14
- Granted: 2024-10-15
- Earliest claimed: 2016-12-06
- Assignees: The Regents of the University of California
- Applicants: The Regents of the University of California
- Inventors: Ying Li; Wentai Liu; Yi-Kai Lo
- Web page: https://patentgrep.com/patent/US12119120B2

## CPC

- G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/055: involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
- A61B 5/291: for electroencephalography [EEG]
- A61B 5/372: Analysis of electroencephalograms
- A61B 5/374: Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
- A61B 5/378: Visual stimuli
- A61B 5/395: Details of stimulation, e.g. nerve stimulation to elicit EMG response
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/721: {using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured}
- A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- A61B 6/032: {Transmission computed tomography [CT]}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/08: Arrangements or circuits for monitoring, protecting, controlling or indicating {(for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925)}
- A61N 1/205: {for promoting a biological process}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N 1/36031: {using physiological parameters for adjustment}
- G06F 17/11: for solving equations {, e.g. nonlinear equations, general mathematical optimization problems (optimization specially adapted for a specific administrative, business or logistic context G06Q10/04)}
- G06F 30/23: using finite element methods [FEM] or finite difference methods [FDM]
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 30/40: for processing medical images, e.g. editing
- G16H 40/60: for the operation of medical equipment or devices
- G16H 70/20: relating to practices or guidelines
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- G06F 2111/10: Numerical modelling
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- 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)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

Methods, apparatus, and systems are disclosed for optimization techniques and a realistic 3D model to design optimal parameters for transcutaneous stimulation to achieve focalized stimulation of a target tissue such as the spinal cord, brain or other internal organ. The methods, apparatus, and systems include generation of a 3D model from a CT/MRI image, as well as an optimization algorithm that enables stimulation of any target location (e.g., on the dorsal root, or on the dorsal column) with any orientation at high precision.

## Claims

### Claim 1

A system comprising:
a stimulation array comprising multiple stimulation electrodes arranged in an array;
a stimulator circuit configured to provide independent stimulation signals to individual electrodes in the stimulator electrode array at a plurality of frequencies, intensities, and/or waveforms;
an external device comprising:
a non-transitory memory storing instructions, and
a processor configured to access the non-transitory memory and execute the instructions to at least:
receive one or more structural images of a target treatment region of a patient when the stimulation array is placed within the target treatment region;
generate a 3D model of the target treatment region based on the one or more structural images of the target treatment region;
calculate, based on the 3D model of the target treatment region, a lead field matrix associated with the stimulation electrode array and the target treatment region;
determine a safety limit for transcutaneous stimulation of the target treatment region;
generate a set of stimulation parameters for a stimulation to be delivered by the multiple stimulation electrodes based on the lead field matrix and the safety limit, wherein the set of stimulation parameters provides both high intensity and focal accuracy within the safety limit by assigning a relative weight to directional intensity and focality of stimulation at the target treatment region; and
configure the stimulator circuit to operate utilizing the generated set of stimulation parameters to deliver the stimulation with the set of stimulation parameters to the patient transcutaneously.

### Claim 2 (depends on 1)

The system of claim 1, wherein the 3D model of the target treatment region is generated by:
segmenting the one or more structural images into different tissues according to grey levels;
generating a target tissue model of the target treatment region for each of the different tissues;
constructing an electrode model based on the stimulation electrode array and the constructed target tissues model;
discretizing the target tissue model and electrode model into a large number of voxels to form a finite element model; and
calculating a lead field matrix of the finite element model.

### Claim 3 (depends on 1)

The system of claim 1, wherein the one or more structural images comprise MRI or CT images.

### Claim 4 (depends on 1)

The system of claim 1, wherein the target treatment region comprises spinal cord or spinal nerves, or a brain structure.

### Claim 5 (depends on 1)

The system of claim 1, wherein the target treatment region comprises an internal organ.

### Claim 6 (depends on 1)

The system of claim 1:
wherein the safety limit is determined according to a function
{
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x
i
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i
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avoid
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ratio
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Intensity
target
;
and
wherein Imax represents a maximum current at each electrode, Itotal denotes a maximum total injected current, and ratio represents an intensity ratio between the target treatment region and an avoidance region.

### Claim 7 (depends on 1)

The system of claim 1, wherein the set of stimulation parameters is generated according to
x
proposed
=
arg
min
x
1
w
⁢
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avoid
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target
;
wherein w is a constant equal to a ratio between a total number of voxels and a number of targeted voxels;
wherein
arg
min
x
1
w
⁢

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2
2
applies the focality and λ*e0TCx applies to the directional intensity; and
wherein λ is the parameter that assigns a weight to a directional intensity and focality.

### Claim 8 (depends on 1)

The system of claim 1, further comprising:
one or more sensors selected from a group of physiological sensors consisting of EEG, EMG, EKG, ECOG, LFP, spike recording, accelerometer, PPG, SpO2, respiration, and skin impedance signals;
wherein said stimulator circuit utilizes said sensors for monitoring patient conditions, as well as for feedback control and/or feedforward control.

### Claim 9 (depends on 1)

The system of claim 1, wherein the instructions further comprise:
deliver a stimulation to a therapy subject through the stimulator electrode array;
collect one or more physiological signals, selected from a group of signals consisting of EEG, EMG, EKG, ECOG, LFP, spike recording, accelerometer, PPG, SpO2, respiration, and skin impedance signals;
adjust one or more parameters of the safety limits and/or the lead field matrix are adjusted in response to measured physiological signals; and
generate an updated set of parameters.

### Claim 10 (depends on 1)

The system of claim 1, wherein multiple targets within the target region are simultaneously stimulated and/or a designated region within the target tissue region is avoided.

### Claim 11 (depends on 1)

The system of claim 1, wherein the stimulator circuit comprises a global controller and a plurality of local controllers.

### Claim 12 (depends on 11)

The system of claim 11, wherein both the global controller and the plurality of local controllers are configured to accept data packets for a stimulation configuration over a single input.

### Claim 13 (depends on 1)

The system of claim 1, the stimulator circuit is further configured to evoke a 2-D or 3-D electric field pattern in-vitro by selectively choosing the stimulation channels, intensities, polarities, and return channel from selected electrodes within the stimulator electrode array.

### Claim 14 (depends on 1)

The system of claim 1, wherein the return electrode is selected from a single or a subset of the electrodes in the stimulator electrode array or by placing a return on an opposing side of the target tissue region.

### Claim 15 (depends on 1)

The system of claim 1, wherein the stimulator circuit is configured for treatment of a movement disorder selected from a group of movement disorders consisting of spinal cord injury, stroke, cerebral palsy, and Parkinson's disease.

### Claim 16 (depends on 1)

The system of claim 1, wherein the stimulator circuit is configured for treatment of disorders involving regulation of a patient autonomic system selected from a group of regulated responses consisting of blood pressure, heart rate, gastrointestinal motility, and inflammatory responses.