# US 12,005,256 B2 · Adjustment of analgesic stimulation parameters based on trust dynamic measurements

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- Number: US 12,005,256 B2
- Document ID: US12005256B2
- Status: Granted
- Kind: B2
- Application number: 18/218,951
- Filed: 2023-07-06
- Published: 2023-11-02
- Granted: 2024-06-11
- Earliest claimed: 2018-05-22
- Assignees: Boston Scientific Neuromodulation Corporation
- Applicants: Boston Scientific Neuromodulation Corporation
- Inventors: James R. Kozloski; Anup Kalia; Jeffrey Rogers; Sara E. Berger
- Web page: https://patentgrep.com/patent/US12005256B2

## CPC

- A61N 1/36132: {using patient feedback}
- A61N 1/025: {Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors}
- A61N 1/36071: {Pain}
- A61N 1/36135: {using physiological parameters}
- A61N 1/36175: {Pulse width or duty cycle}
- A61N 1/36189: {using modulation techniques}
- A61N 1/37235: {Aspects of the external programmer}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- 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 pain of a human subject, through the use and adjustment of analgesic stimulation parameters based on trust dynamics and trust measurements. In an example, the system to establish programming of the neurostimulation device performs operations that: determine a trust measurement value that is derived from results of at least one commitment made with a human subject, via observable interactions; determine a modification of at least one neurostimulation programming parameter, based on the trust measurement value; and to cause the implantable neurostimulation device to implement the modification of the at least one neurostimulation programming parameter. Further examples are provided to produce and track the trust measurement value, as well as identify a pain susceptibility value and determine a receptiveness to analgesic effects based on these and other trust dynamics.

## Claims

### Claim 1

A computer system for determining programming of an implantable electrical neurostimulation device used for treating pain of a human subject, the system comprising:
data processing circuitry configured to:
receive a trust measurement value associated with a trust state of the human subject, the trust state based on outcomes of interactions between at least one entity and the human subject;
determine a treatment adjustment value associated with efficacy of pain treatment of the human subject, based on the trust measurement value; and
generate at least one neurostimulation programming parameter of the implantable neurostimulation device, based on the treatment adjustment value; and
neurostimulation programming circuitry configured to:
generate programming data for use with the implantable neurostimulation device, the programming data to cause the implantable neurostimulation device to implement the at least one neurostimulation programming parameter and provide the pain treatment to the human subject with neurostimulation using the at least one neurostimulation programming parameter.

### Claim 2 (depends on 1)

The computer system of claim 1, wherein the treatment adjustment value is based on pain susceptibility or treatment susceptibility applicable to the human subject, and wherein the data processing circuitry further determines the pain susceptibility or the treatment susceptibility applicable to the human subject based on the outcomes of the interactions between the at least one entity and the human subject.

### Claim 3 (depends on 1)

The computer system of claim 1, wherein the outcomes of the interactions include positive outcomes and negative outcomes, and wherein the trust measurement value provides a measurement of a level or ratio of the positive outcomes to the negative outcomes.

### Claim 4 (depends on 3)

The computer system of claim 3, wherein the outcomes are evaluated from commitments having previously occurred between the at least one entity and the human subject, wherein the positive outcomes represent a fulfillment of respective commitments, and wherein the negative outcomes represent a violation of respective commitments.

### Claim 5 (depends on 1)

The computer system of claim 1, wherein the trust state is represented by a data structure comprising a neural network or a graph, and wherein the trust measurement value is obtained from the data structure.

### Claim 6 (depends on 1)

The computer system of claim 1, wherein the outcomes of the interactions are based on at least one electronic interaction involving text or voice conversations, and wherein the at least one entity includes a chatbot or automated agent.

### Claim 7 (depends on 1)

The computer system of claim 1, wherein the programming data is generated by the neurostimulation programming circuitry using a program modeling system, wherein the program modeling system enables exploration of a set of possible neurostimulation programs and program settings based on feedback related to the trust state of the human subject and a treatment state of the human subject.

### Claim 8 (depends on 1)

The computer system of claim 1, wherein the at least one neurostimulation programming parameter controls modulated energy provided with a plurality of leads of the implantable neurostimulation device, 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 (depends on 8)

The computer system of claim 8, the neurostimulation programming circuitry further configured to:
communicate the programming data to the implantable neurostimulation device, to create or update a neurostimulation program for the implantable neurostimulation device, wherein use of the neurostimulation program in the implantable neurostimulation device causes delivery of the modulated energy to the human subject.

### Claim 10

A non-transitory machine-readable storage medium comprising instructions for determining programming of an implantable electrical neurostimulation device used for treating pain of a human subject, the instructions, when executed by circuitry of a machine, cause the machine to:
identify a trust measurement value associated with a trust state of the human subject, the trust state based on outcomes of interactions between at least one entity and the human subject;
determine a treatment adjustment value associated with efficacy of pain treatment of the human subject, based on the trust measurement value;
generate at least one neurostimulation programming parameter of the implantable neurostimulation device, based on the treatment adjustment value; and
output programming data for use with the implantable neurostimulation device, the programming data to cause the implantable neurostimulation device to implement the at least one neurostimulation programming parameter and provide the pain treatment to the human subject with neurostimulation using the at least one neurostimulation programming parameter.

### Claim 11 (depends on 10)

The machine-readable storage medium of claim 10, wherein the treatment adjustment value is based on pain susceptibility or treatment susceptibility applicable to the human subject, and wherein the instructions further to cause the machine to determine the pain susceptibility or the treatment susceptibility applicable to the human subject based on the outcomes of the interactions between the at least one entity and the human subject.

### Claim 12 (depends on 10)

The machine-readable storage medium of claim 10, wherein the outcomes of the interactions include positive outcomes and negative outcomes, wherein the trust measurement value provides a measurement of a level or ratio of the positive outcomes to the negative outcomes, wherein the outcomes are evaluated from commitments having previously occurred between the at least one entity and the human subject, and wherein the positive outcomes represent a fulfillment of respective commitments, and wherein the negative outcomes represent a violation of respective commitments.

### Claim 13 (depends on 10)

The machine-readable storage medium of claim 10, wherein the trust state is represented by a data structure comprising a neural network or a graph, and wherein the trust measurement value is obtained from the data structure.

### Claim 14 (depends on 10)

The machine-readable storage medium of claim 10, wherein the programming data is generated by the machine using a program modeling system, wherein the program modeling system enables exploration of a set of possible neurostimulation programs and program settings based on feedback related to the trust state of the human subject and a treatment state of the human subject.

### Claim 15

A method for determining programming of an implantable electrical neurostimulation device used for treating pain of a human subject, comprising:
identifying a trust measurement value associated with a trust state of the human subject, the trust state based on outcomes of interactions between at least one entity and the human subject;
determining a treatment adjustment value associated with efficacy of pain treatment of the human subject, based on the trust measurement value;
generating at least one neurostimulation programming parameter of the implantable neurostimulation device, based on the treatment adjustment value; and
providing programming data for use with the implantable neurostimulation device, the programming data to cause the implantable neurostimulation device to implement the at least one neurostimulation programming parameter and provide the pain treatment to the human subject with neurostimulation using the at least one neurostimulation programming parameter.

### Claim 16 (depends on 15)

The method of claim 15, wherein the treatment adjustment value is based on pain susceptibility or treatment susceptibility applicable to the human subject, and wherein the method further comprises determining the pain susceptibility or the treatment susceptibility applicable to the human subject based on the outcomes of the interactions between the at least one entity and the human subject.

### Claim 17 (depends on 15)

The method of claim 15, wherein the outcomes of the interactions include positive outcomes and negative outcomes, wherein the trust measurement value provides a measurement of a level or ratio of the positive outcomes to the negative outcomes, wherein the outcomes are evaluated from commitments having previously occurred between the at least one entity and the human subject, and wherein the positive outcomes represent a fulfillment of respective commitments, and wherein the negative outcomes represent a violation of respective commitments.

### Claim 18 (depends on 15)

The method of claim 15, wherein the trust state is represented by a data structure comprising a neural network or a graph, and wherein the trust measurement value is obtained from the data structure.

### Claim 19 (depends on 15)

The method of claim 15, wherein the programming data is generated using a program modeling system, wherein the program modeling system enables exploration of a set of possible neurostimulation programs and program settings based on feedback related to the trust state of the human subject and a treatment state of the human subject.

### Claim 20 (depends on 15)

The method of claim 15, wherein the programming data controls modulated energy provided with a plurality of leads of the implantable neurostimulation device, for one or more of: pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes.
