# US 12,109,420 B2 · Systems and methods for optimized waveform generation

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- Number: US 12,109,420 B2
- Document ID: US12109420B2
- Status: Granted
- Kind: B2
- Application number: 17/091,469
- Filed: 2020-11-06
- Published: 2022-05-12
- Granted: 2024-10-08
- Earliest claimed: 2020-11-06
- Assignees: Advanced Neuromodulation Systems, Inc.
- Applicants: Advanced Neuromodulation Systems, Inc.
- Inventors: Anahita Kyani; Jagatkumar Shah; Douglas Lautner; Ali Taheri; Simeng Zhang; Yagna Pathak; Erika Ross; Hyun-Joo Park
- Web page: https://patentgrep.com/patent/US12109420B2

## CPC

- A61N 1/36062: {Spinal stimulation}
- A61N 1/36564: {controlled by blood pressure}
- A61B 5/0215: by means inserted into the body
- A61B 5/37: Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61N 1/36067: {Movement disorders, e.g. tremor or Parkinson disease (stimulating motor muscle A61N1/36003)}
- A61N 1/36132: {using patient feedback}
- A61N 1/36146: {specified by the stimulation parameters}
- 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

Provided herein is a computing system for optimizing a waveform, in communication with an implantable pulse generator, and including a computing device including a memory device and a processor communicatively coupled to the memory device. The processor is configured to: retrieve historical waveform data associated with a plurality of waveforms used in therapeutic sessions for a plurality of patients, the historical waveform data including a plurality of waveform parameters; analyzing the historical waveform data to determine preferred waveform parameters; determining that a patient is starting a new therapeutic session using the patient therapeutic device; displaying each of the preferred waveform parameters; prompting the user to accept or modify the displayed waveform parameters; optimizing the waveform parameters for the therapeutic session; and transmitting the optimized waveform parameters to the patient therapeutic device to start the therapeutic session.

## Claims

### Claim 1

A computing system for optimizing a waveform, the computing system in communication with an implantable pulse generator, the computing system comprising:
a computing device including a memory device and a processor communicatively coupled to the memory device, the processor configured to:
retrieve, from the memory device, historical waveform data associated with a plurality of waveforms used in therapeutic sessions for a population of patients, the historical waveform data including a plurality of waveform parameters, the population of patients including a plurality of patients;
group each of the plurality of patients into an associated sub-set of a plurality of sub-sets of the population of patients, wherein each sub-set of the plurality of sub-sets groups patients based on at least one of age, height and weight, sex, disorder being treated, and beginning pain level;
analyze the historical waveform data to determine preferred waveform parameters;
determine that a patient is starting a new therapeutic session using a patient therapeutic device;
receive, from the patient therapeutic device, patient data associated with the patient;
compare the patient data with each of the plurality of sub-sets to determine a particular sub-set of the plurality of sub-sets that corresponds to the patient data;
determine, from the historical waveform data for the patients grouped in the determined particular sub-set, the preferred waveform parameters for the determined particular sub-set;
display, on a user interface, each of the preferred waveform parameters for the determined particular sub-set of the population of the patient;
prompt a user for user input associated with the preferred waveform parameters, the user input including accepting or modifying the preferred waveform parameters;
optimize, based upon the user input, waveform parameters for the new therapeutic session by analyzing, using at least one of machine learning and artificial intelligence, the historical waveform data for the patients grouped in the determined particular sub-set to determine patterns of the waveform parameters in the historical waveform data that led to desirable results for those patients; and
transmit the optimized waveform parameters to the patient therapeutic device to start the therapeutic session.

### Claim 2 (depends on 1)

The computing system of claim 1, wherein determining each of the preferred waveform parameters causes the processor to be configured to:
determine, from the historical waveform data, a most frequent value of each of the waveform parameters for the plurality of patients.

### Claim 3 (depends on 2)

The computing system of claim 2, wherein the patient data includes at least one of an age, a sex, a height, a weight, an ethnicity, and a current pain level, and wherein the processor is further configured to:
determine the preferred waveform parameters and the optimized waveform parameters that provide results for the plurality of patients.

### Claim 4 (depends on 1)

The computing system of claim 1, wherein the processor is further configured to:
prompt the user to input a type of waveform to be used in the new therapeutic session, wherein the type of waveform is a tonic waveform or a burst waveform.

### Claim 5 (depends on 4)

The computing system of claim 4, wherein the processor is further configured to determine the preferred waveform parameters based upon the type of waveform.

### Claim 6 (depends on 5)

The computing system of claim 5, wherein the waveform parameters for (i) the tonic waveform include a frequency, a pulse-width, and an amplitude or for (ii) the burst waveform include a number of pulses, an intra-burst frequency, an inter-burst frequency, a pulse width, and an amplitude.

### Claim 7

A method for optimizing a waveform, the method implemented by a computing system in communication with an implantable pulse generator, the computing system including a processor in communication with a memory device, the method comprising:
retrieving, from the memory device, historical waveform data associated with a plurality of waveforms used in therapeutic sessions for a population of patients, the historical waveform data including a plurality of waveform parameters, the population of patients including a plurality of patients;
grouping each of the plurality of patients into an associated sub-set of a plurality of sub-sets of the population of patients, wherein each sub-set of the plurality of sub-sets groups patients based on at least one of age, height and weight, sex, disorder being treated, and beginning pain level;
analyzing the historical waveform data to determine preferred waveform parameters;
determining that a patient is starting a new therapeutic session using a patient therapeutic device;
receiving, from the patient therapeutic device, patient data associated with the patient;
comparing the patient data with each of the plurality of sub-sets to determine a particular sub-set of the plurality of sub-sets that corresponds to the patient data;
determining, from the historical waveform data for the patients grouped in the determined particular sub-set, the preferred waveform parameters for the determined particular sub-set;
displaying, on a user interface, each of the preferred waveform parameters for the determined particular sub-set of the population of the patient;
prompting a user for user input associated with the preferred waveform parameters, the user input including accepting or modifying the preferred waveform parameters;
optimizing, based upon the user input, waveform parameters for the new therapeutic session by analyzing, using at least one of machine learning and artificial intelligence, the historical waveform data for the patients grouped in the determined particular sub-set to determine patterns of the waveform parameters in the historical waveform data that led to desirable results for those patients; and
transmitting the optimized waveform parameters to the patient therapeutic device to start the therapeutic session.

### Claim 8 (depends on 7)

The method of claim 7, wherein determining each of the preferred waveform parameters comprises:
determining, from the historical waveform data, a most frequent value of each of the waveform parameters for the plurality of patients.

### Claim 9 (depends on 8)

The method of claim 8, wherein the patient data includes at least one of an age, a sex, a height, a weight, an ethnicity, and a current pain level, and wherein the method further comprises:
determining the preferred waveform parameters and the optimized waveform parameters that provide results for the plurality of patients.

### Claim 10 (depends on 7)

The method of claim 7 further comprising:
prompting the user to input a type of waveform to be used in the new therapeutic session, wherein the type of waveform is a tonic waveform or a burst waveform.

### Claim 11 (depends on 10)

The method of claim 10 further comprising determining the preferred waveform parameters based upon the type of waveform.

### Claim 12 (depends on 11)

The method of claim 11, wherein the waveform parameters for (i) the tonic waveform include a frequency, a pulse-width, and an amplitude or for (ii) the burst waveform include a number of pulses, an intra-burst frequency, an inter-burst frequency, a pulse width, and an amplitude.

### Claim 13

Non-transitory computer-readable media having computer-executable instructions thereon, wherein when executed by a processor of a computing device communicatively coupled to a memory device, cause the processor of the computing device to:
retrieve, from the memory device, historical waveform data associated with a plurality of waveforms used in therapeutic sessions for a population of patients, the historical waveform data including a plurality of waveform parameters, the population of patients including a plurality of patients;
group each of the plurality of patients into an associated sub-set of a plurality of sub-sets of the population of patients, wherein each sub-set of the plurality of sub-sets groups patients based on at least one of age, height and weight, sex, disorder being treated, and beginning pain level;
analyze the historical waveform data to determine preferred waveform parameters;
determine that a patient is starting a new therapeutic session using a patient therapeutic device;
receive, from the patient therapeutic device, patient data associated with the patient;
compare the patient data with each of the plurality of sub-sets to determine a particular sub-set of the plurality of sub-sets that corresponds to the patient data;
determine, from the historical waveform data for the patients grouped in the determined particular sub-set, the preferred waveform parameters for the determined particular sub-set;
display, on a user interface, each of the preferred waveform parameters for the determined particular sub-set of the population of the patient;
prompt a user for user input associated with the preferred waveform parameters, the user input including accepting or modifying the preferred waveform parameters;
optimize, based upon the user input, waveform parameters for the new therapeutic session by analyzing, using at least one of machine learning and artificial intelligence, the historical waveform data for the patients grouped in the determined particular sub-set to determine patterns of the waveform parameters in the historical waveform data that led to desirable results for those patients; and
transmit optimized waveform parameters to the patient therapeutic device to start the therapeutic session.

### Claim 14 (depends on 13)

The non-transitory computer-readable media of claim 13, wherein the computer-executable instructions further cause the processor to:
determine, from the historical waveform data, a most frequent value of each of the waveform parameters for the plurality of patients.

### Claim 15 (depends on 14)

The non-transitory computer-readable media of claim 14, wherein the patient data includes at least one of an age, a sex, a height, a weight, an ethnicity, and a current pain level, and wherein the computer-executable instructions further cause the processor to:
determine the preferred waveform parameters and the optimized waveform parameters that provide results for the plurality of patients.

### Claim 16 (depends on 13)

The non-transitory computer-readable media of claim 13, wherein the computer-executable instructions further cause the processor to:
prompt the user to input a type of waveform to be used in the new therapeutic session, wherein the type of waveform is a tonic waveform or a burst waveform.

### Claim 17 (depends on 16)

The non-transitory computer-readable media of claim 16, wherein the computer-executable instructions further cause the processor to determine the preferred waveform parameters based upon the type of waveform.

### Claim 18 (depends on 1)

The computing system of claim 1, wherein to determine patterns of the waveform parameters in the historical waveform data that led to desirable results, the processor is configured to determine the patterns based on at least one of i) particular waveform parameters that were maintained after multiple trials and ii) patient input data providing feedback on the waveform parameters in the historical waveform data.