# US 12,005,255 B2 · Adaptive electrical neurostimulation treatment to reduce pain perception

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- Number: US 12,005,255 B2
- Document ID: US12005255B2
- Status: Granted
- Kind: B2
- Application number: 18/131,269
- Filed: 2023-04-05
- Published: 2023-08-03
- Granted: 2024-06-11
- Earliest claimed: 2018-05-22
- Assignees: Boston Scientific Neuromodulation Corporation
- Applicants: Boston Scientific Neuromodulation Corporation
- Inventors: Qinghuang Lin; Jeffrey Rogers; Giovanni Russo; Andrea Simonetto; Tigran Tchrakian
- Web page: https://patentgrep.com/patent/US12005255B2

## CPC

- A61N 1/36071: {Pain}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/36167: {Timing, e.g. stimulation onset}
- A61N 1/36189: {using modulation techniques}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61N 1/37264: {Changing the program; Upgrading firmware}
- G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Systems and techniques are disclosed to establish programming of an implantable electrical neurostimulation device for treating chronic pain of a human subject, through the use of a dynamic model adapted to determine pain treatment parameters for a human patient and identify a new device operational program to implement the pain treatment parameters to address the chronic pain condition. In an example, the system to establish programming of the neurostimulation device performs operations that: obtain state data indicating a measured value that is correlated to pain experienced by the human subject; determine neurostimulation programming parameters, using a dynamic model, for pain treatment in the human subject, as the dynamic model is used to identify values of the neurostimulation programming parameters that predict an improvement to the measured value; and indicate a neurostimulation program for the neurostimulation device, that includes the neurostimulation programming parameters for the implantable electrical neurostimulation device.

## Claims

### Claim 1

A computing system for determining programming of an implantable electrical neurostimulation device used for treating chronic pain of a human subject, the computing system comprising:
a storage medium to store patient state data, the patient state data including at least one measurement of a patient state that corresponds to pain experienced by the human subject;
processing circuitry to execute a dynamic model to process the patient state data, the dynamic model trained to output a plurality of neurostimulation programming parameters for pain treatment in the human subject, wherein the dynamic model uses a time model to generate predicted results of the pain treatment for the human subject forward in time, and wherein the dynamic model selects the plurality of neurostimulation programming parameters based on an improvement of the at least one measurement in the predicted results of the pain treatment; and
communication circuitry to transmit commands that cause programming of the implantable electrical neurostimulation device with the plurality of neurostimulation programming parameters.

### Claim 2 (depends on 1)

The computing system of claim 1, wherein the processing circuitry is further to provide a user interface for use by the human subject, and wherein the at least one measurement of the patient state is obtained in the user interface based on inputs from the human subject.

### Claim 3 (depends on 2)

The computing system of claim 2, wherein the processing circuitry is configured to extract the patient state data from the inputs received in the user interface, and wherein the inputs received in the user interface for the human subject relate to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction.

### Claim 4 (depends on 1)

The computing system of claim 1, wherein the processing circuitry is further to provide a user interface for use by a caregiver of the human subject, and wherein the at least one measurement of the patient state is obtained in in the user interface based on inputs from the caregiver.

### Claim 5 (depends on 4)

The computing system of claim 4, wherein the processing circuitry is configured to extract the patient state data from the inputs received in the user interface, and wherein the inputs received in the user interface relate to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction of the human subject.

### Claim 6 (depends on 1)

The computing system of claim 1, wherein the plurality of neurostimulation programming parameters are determined with an exploration phase of program modeling with the dynamic model, and wherein the exploration phase of program modeling is used to identify an improvement in a quantity of interest corresponding to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction.

### Claim 7 (depends on 1)

The computing system of claim 1, wherein the dynamic model utilizes a plurality of model parameters that are specific to the human subject, and wherein the dynamic model is (i) a continuous time model that uses dynamic equations to evaluate variations in pain treatment parameters in a continuous time period, or (ii) a discrete time model that uses dynamic equations to evaluate variations in pain treatment parameters in a discrete time period.

### Claim 8 (depends on 1)

The computing system of claim 1, wherein deployment of the plurality of neurostimulation programming parameters causes a change in operation of the implantable electrical neurostimulation device, which causes observable effects to the at least one measurement of the patient state, and
wherein the plurality of neurostimulation programming parameters specify a change in programming for modulated energy provided with a plurality of leads of the implantable electrical neurostimulation device, the change in programming specified for one or more of: pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes.

### Claim 9

A non-transitory machine-readable medium comprising instructions for determining programming of an implantable electrical neurostimulation device used for treating chronic pain of a human subject, wherein the instructions, which when executed by a computing system, cause the computing system to perform operations comprising:
accessing patient state data, the patient state data including at least one measurement of a patient state that corresponds to pain experienced by the human subject;
executing a dynamic model to process the patient state data, the dynamic model trained to output a plurality of neurostimulation programming parameters for pain treatment in the human subject, wherein the dynamic model uses a time model to generate predicted results of the pain treatment for the human subject forward in time, and wherein the dynamic model selects the plurality of neurostimulation programming parameters based on an improvement of the at least one measurement in the predicted results of the pain treatment; and
causing commands to be transmitted that cause programming of the implantable electrical neurostimulation device with the plurality of neurostimulation programming parameters.

### Claim 10 (depends on 9)

The non-transitory machine-readable medium of claim 9, wherein the at least one measurement of the patient state is based on inputs received from the human subject in a user interface, and wherein the inputs received in the user interface for the human subject relate to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction.

### Claim 11 (depends on 9)

The non-transitory machine-readable medium of claim 9, wherein the at least one measurement of the patient state is based on inputs received from a caregiver of the human subject in a user interface, and wherein the inputs received in the user interface for the human subject relate to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction of the human subject.

### Claim 12 (depends on 9)

The non-transitory machine-readable medium of claim 9, wherein the plurality of neurostimulation programming parameters are determined with an exploration phase of program modeling with the dynamic model, and wherein the exploration phase of program modeling is used to identify an improvement in a quantity of interest corresponding to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction.

### Claim 13 (depends on 9)

The non-transitory machine-readable medium of claim 9, wherein the dynamic model utilizes a plurality of model parameters that are specific to the human subject, and wherein the dynamic model is (i) a continuous time model that uses dynamic equations to evaluate variations in pain treatment parameters in a continuous time period, or (ii) a discrete time model that uses dynamic equations to evaluate variations in pain treatment parameters in a discrete time period.

### Claim 14 (depends on 9)

The non-transitory machine-readable medium of claim 9, wherein the commands cause a change in operation of the implantable electrical neurostimulation device, which causes observable effects to the at least one measurement of the patient state, and
wherein the plurality of neurostimulation programming parameters specify a change in programming for modulated energy provided with a plurality of leads of the implantable electrical neurostimulation device, the change in programming specified for one or more of: pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes.

### Claim 15

A method, for causing programming of an implantable electrical neurostimulation device used for treating chronic pain of a human subject, implemented with at least one processor of a device, the method comprising:
accessing patient state data, the patient state data including at least one measurement of a patient state that corresponds to pain experienced by the human subject;
executing a dynamic model to process the patient state data, the dynamic model trained to output a plurality of neurostimulation programming parameters for pain treatment in the human subject, wherein the dynamic model uses a time model to generate predicted results of the pain treatment for the human subject forward in time, and wherein the dynamic model selects the plurality of neurostimulation programming parameters based on an improvement of the at least one measurement in the predicted results of the pain treatment; and
causing commands to be transmitted that cause programming of the implantable electrical neurostimulation device with the plurality of neurostimulation programming parameters.

### Claim 16 (depends on 15)

The method of claim 15, wherein the at least one measurement of the patient state is based on inputs received from the human subject in a user interface, and wherein the inputs received in the user interface for the human subject relate to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction.

### Claim 17 (depends on 15)

The method of claim 15, wherein the at least one measurement of the patient state is based on inputs received from a caregiver of the human subject in a user interface, and wherein the inputs received in the user interface for the human subject relate to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction of the human subject.

### Claim 18 (depends on 15)

The method of claim 15, wherein the plurality of neurostimulation programming parameters are determined with an exploration phase of program modeling with the dynamic model, and wherein the exploration phase of program modeling is used to identify an improvement in a quantity of interest corresponding to at least one of: a measurement of pain, pain characteristics, quality of sleep, quality of life, or patient satisfaction.

### Claim 19 (depends on 15)

The method of claim 15, wherein the dynamic model utilizes a plurality of model parameters that are specific to the human subject, and wherein the dynamic model is (i) a continuous time model that uses dynamic equations to evaluate variations in pain treatment parameters in a continuous time period, or (ii) a discrete time model that uses dynamic equations to evaluate variations in pain treatment parameters in a discrete time period.

### Claim 20 (depends on 15)

The method of claim 15, wherein the commands cause a change in operation of the implantable electrical neurostimulation device, which causes observable effects to the at least one measurement of the patient state, and
wherein the plurality of neurostimulation programming parameters specify a change in programming for modulated energy provided with a plurality of leads of the implantable electrical neurostimulation device, the change in programming specified for one or more of: pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes.
