# US 11,110,277 B2 · System and method of performing computer assisted stimulation programming (CASP) with a non-zero starting value customized to a patient > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,110,277 B2 - Document ID: US11110277B2 - Status: Granted - Kind: B2 - Application number: 16/131,393 - Filed: 2018-09-14 - Published: 2019-01-10 - Granted: 2021-09-07 - Earliest claimed: 2015-06-09 - Assignees: Cirtec Medical Corp. - Applicants: Cirtec Medical Corporation - Inventors: Norbert Kaula; Yohannes Iyassu - Web page: https://patentgrep.com/patent/US11110277B2 ## CPC - A61N 1/36132: {using patient feedback} - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - A61N 1/3605: {Implantable neurostimulators for stimulating central or peripheral nerve system} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising - G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture - G16H 40/63: for local operation - G16H 40/67: for remote operation - G16H 50/50: for simulation or modelling of medical disorders - G16Z 99/00: Subject matter not provided for in other main groups of this subclass - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61N 1/36107: {Sexual dysfunction (stimulating genital organs A61N1/36007)} - A61N 1/36185: {Selection of the electrode configuration} - A61N 1/37264: {Changing the program; Upgrading firmware} - 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 - G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR ## Abstract A non-zero starting value for ramping up a stimulation parameter for an electrical stimulation to be delivered to a patient is determined. The non-zero starting value is customized to the patient. A pulse generator is caused to generate the electrical stimulation, which is delivered to the patient via an implanted lead. The pulse generator is caused to ramp up, from the determined non-zero starting value and toward a predefined maximum limit value, the stimulation parameter for a plurality of electrode contacts on the lead. Feedback is received from the patient in response to the ramping up. The feedback is received via an electronic patient feedback device. Based on the ramping up and the received feedback from the patient, a perception threshold is determined for each of the plurality of electrode contacts. The perception threshold is a value of the stimulation parameter that corresponds to the patient feeling the electrical stimulation. ## Claims ### Claim 1 A method, comprising: applying an electrical stimulation to a patient via a lead having one or more electrodes located thereon; increasing a stimulation parameter of the electrical stimulation, wherein the stimulation parameter includes stimulation amplitude, stimulation pulse width, or stimulation frequency; monitoring a variation of an evoked action potential while the stimulation parameter is being increased from a previous value to a current value; determining, based on the monitoring, an amount of increase between each evoked action potential corresponding to the current value of the stimulation parameter and a previous evoked action potential corresponding to the previous value of the stimulation parameter; determining, based on the amount of increase, whether a threshold of the evoked action potential has been reached; and in response to a determination that the threshold of the evoked action potential has been reached, recording a first value of the stimulation parameter that resulted in the threshold of the evoked action potential being reached. ### Claim 2 (depends on 1) The method of claim 1, further comprising: using the first value of the stimulation parameter in a computer assisted programming process in which the stimulation parameter is automatically adjusted by a computer processor. ### Claim 3 (depends on 2) The method of claim 2, wherein the using the first value comprises assigning the first value of the stimulation parameter as a starting value in the computer assisted programming process. ### Claim 4 (depends on 2) The method of claim 2, wherein the using the first value comprises: calculating a second value as a function of the first value; and assigning the second value as a starting value in the computer assisted programming process. ### Claim 5 (depends on 4) The method of claim 4, wherein the calculating the second value comprises subtracting the first value by a predetermined value, wherein the predetermined value is less than the first value. ### Claim 6 (depends on 2) The method of claim 2, further comprising: performing the computer assisted programming process to determine a perception threshold of the one or more electrodes of the lead. ### Claim 7 (depends on 1) The method of claim 1, wherein the monitoring comprises receiving the evoked action potential measured by one or more sensing electrodes. ### Claim 8 (depends on 7) The method of claim 7, wherein the one or more sensing electrodes are located separately from the lead. ### Claim 9 (depends on 8) The method of claim 8, wherein: the one or more electrodes include a plurality of electrodes; a first subset of the plurality of electrodes is used as stimulation electrodes to apply the electrical stimulation to the patient; and a second subset of the plurality of electrodes is used as the sensing electrodes to measure the evoked action potential. ### Claim 10 (depends on 1) The method of claim 1, wherein the determining whether the threshold of the evoked action potential has been reached comprises determining whether the rate of increase exhibits an exponential behavior. ### Claim 11 (depends on 1) The method of claim 1, wherein the applying, the increasing, the monitoring, the determining the amount of increase, the determining whether the threshold of the evoked action potential has been reached, and the recording are performed at least in part using an electronic programming device that is configured to program a pulse generator to generate the electrical stimulation. ### Claim 12 (depends on 1) The method of claim 1, further comprising: repeating the applying, the increasing, the monitoring, the determining the amount of increase, the determining whether the threshold of the evoked action potential has been reached, and the recording for each of a plurality of patients, thereby obtaining a plurality of first values, wherein each of the first values is customized to a respective patient. ### Claim 13 (depends on 1) The method of claim 1, wherein the determining the amount of increase comprises determining a percentage increase from each evoked action potential and the previous evoked action potential. ### Claim 14 A method, comprising: applying an electrical stimulation to a patient via a lead having one or more electrodes located thereon; increasing a stimulation parameter of the electrical stimulation, wherein the stimulation parameter includes stimulation amplitude, stimulation pulse width, or stimulation frequency; measuring a change in an evoked action potential while the stimulation parameter is being increased from a previous value to a current value; determining, based on the monitoring, an amount of increase between each evoked action potential corresponding to the current value of the stimulation parameter and a previous evoked action potential corresponding to the previous value of the stimulation parameter; determining, based on the amount of increase, whether the evoked action potential has reached a predefined threshold; in response to a determination that the predefined threshold of the evoked action potential has been reached, recording a first value of the stimulation parameter that resulted in the predefined threshold of the evoked action potential being reached; calculating a starting value of a computer assisted stimulation programming process as a value that is equal to the first value or smaller than the first value by a predefined number, wherein the computer assisted stimulation programming process automatically adjusts the stimulation parameter via a computer processor; performing the computer assisted stimulation programming process, wherein the computer assisted stimulation programming process comprises ramping up the stimulation parameter, for each of the electrodes, from the starting value toward a predetermined maximum value; and determining a perception threshold for each of the electrodes based on the performing of the computer assisted stimulation programming process. ### Claim 15 (depends on 14) The method of claim 14, wherein the measuring comprises measuring the evoked action potential via one or more sensing electrodes that are located outside the lead. ### Claim 16 A system, comprising: a pulse generator configured to generate electrical stimulation; a lead having a plurality of electrodes thereon and configured to deliver the electrical stimulation to a patient; and an electronic programmer configured to perform operations comprising: increasing a stimulation parameter of the electrical stimulation, wherein the stimulation parameter includes stimulation amplitude, stimulation pulse width, or stimulation frequency; monitoring, via a subset of the electrodes as sensing electrodes or using one or more external electrodes as the sensing electrodes, an evoked action potential while the stimulation parameter is being increased from a previous value to a current value; determining, based on the monitoring, an amount of increase between each evoked action potential corresponding to the current value of the stimulation parameter and a previous evoked action potential corresponding to the previous value of the stimulation parameter; determining, based on the amount of increase, whether a threshold of the evoked action potential has been reached; and in response to a determination that the threshold of the evoked action potential has been reached, recording a first value of the stimulation parameter that resulted in the threshold of the evoked action potential being reached. ### Claim 17 (depends on 16) The system of claim 16, wherein the operations further comprise: performing a computer assisted programming process in which the first value or a second value is used as a starting value of the stimulation parameter, wherein the second value is less than the first value by a predetermined amount, wherein the computer assisted stimulation programming process automatically adjusts the stimulation parameter via a computer processor. ### Claim 18 (depends on 17) The system of claim 17, wherein the operations further comprise: determining a perception threshold of the one or more electrodes of the lead based on the computer assisted programming process. ### Claim 19 (depends on 16) The system of claim 16, wherein the determining whether the threshold of the evoked action potential has been reached comprises determining whether the amount of increase is greater than a predefined amount of increase. ### Claim 20 (depends on 16) The system of claim 16, wherein the determining the amount of increase comprises determining a percentage increase from each evoked action potential and the previous evoked action potential.