# US 11,998,746 B2 · System and method for determining a stimulation threshold for closed loop spinal cord stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,746 B2 - Document ID: US11998746B2 - Status: Granted - Kind: B2 - Application number: 17/411,017 - Filed: 2021-08-24 - Published: 2021-12-09 - Granted: 2024-06-04 - Earliest claimed: 2016-11-07 - Assignees: Pacesetter, Inc. - Applicants: Pacesetter, Inc. - Inventors: Wenbo Hou; Fujian Qu; Stuart Rosenberg; Kyungmoo Ryu - Web page: https://patentgrep.com/patent/US11998746B2 ## CPC - A61N 1/36139: {with automatic adjustment} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/36071: {Pain} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - 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) ## Abstract System and methods are provided for determining a stimulation threshold for closed loop spinal cord stimulation (SCS). The system and methods provide a lead coupled to an implantable pulse generator (IPG). The system and methods deliver SCS pulses from the IPG to the lead electrodes in accordance with an SCS therapy and determine an evoked compound action potential (ECAP) amplitude based on an ECAP waveform resulting from the SCS therapy. The system and methods increase the SCS therapy by increasing at least one of an amplitude, a duration, and number of the SCS pulses associated with the SCS therapy. The system and methods also include iteratively repeat the delivering, determining and increasing operations until the ECAP amplitude exhibits a downward trend divergence. The system and methods define a stimulation threshold based on the ECAP amplitude at the trend divergence. ## Claims ### Claim 1 A method for determining a stimulation threshold for closed loop spinal cord stimulation (SCS), the method comprising: delivering a series of SCS pulses from at least one lead electrode of a lead coupleable to an implantable pulse generator (IPG) having a processor, the at least one lead electrode configured to be implanted at a target position proximate to or within nerve tissue of interest, the series of SCS pulses configured to form a plurality of SCS waveforms in accordance with SCS therapy parameters; determining, by the processor, an evoked compound action potential (ECAP) amplitude based on an ECAP waveform resulting from the SCS therapy parameters; increasing, by the IPG, at least one of the SCS therapy parameters; iteratively repeating the delivering, determining and increasing until the ECAP amplitude exhibits a downward trend divergence; and defining, by the processor, a stimulation threshold based on the ECAP amplitude at the downward trend divergence. ### Claim 2 (depends on 1) The method of claim 1, further comprising: during the iteratively repeating, determining, by the processor, an average ECAP amplitude; and reducing, by the processor, the stimulation threshold when an instantaneous ECAP amplitude is lower than the average ECAP amplitude. ### Claim 3 (depends on 1) The method of claim 1, wherein the SCS waveforms comprise any of a burst stimulation waveform, a tonic stimulation waveform, a biphasic stimulation waveform, or any combination thereof. ### Claim 4 (depends on 1) The method of claim 1, further comprising determining, by the processor, that the ECAP amplitude exhibits the downward trend divergence, wherein the determining comprises: comparing, by the processor, an ECAP amplitude corresponding to an Nth iteration of the iteratively repeating with an average ECAP amplitude determined based on a plurality of iterations of the iteratively repeating that occurred prior to the Nth iteration. ### Claim 5 (depends on 4) The method of claim 4, wherein the plurality of the iterations corresponds to at least three iterations. ### Claim 6 (depends on 1) The method of claim 1, further comprising: recording, by sensing circuitry of the IPG, an ECAP waveform based on ECAP measurements onto a stimulation database; and wirelessly transmitting ECAP data to an external device. ### Claim 7 (depends on 6) The method of claim 6, wherein the ECAP data comprises amplitude values corresponding to one or more ECAP waveforms. ### Claim 8 (depends on 1) The method of claim 1, further comprising measuring, by sensing circuitry of the IPG, an ECAP waveform proximate to an Aβ sensory fiber. ### Claim 9 (depends on 1) The method of claim 1, further comprising determining, by the processor, a stimulation baseline. ### Claim 10 A non-transitory computer-readable medium comprising instructions that, when executed by a processor of an implantable pulse generator (IPG), cause the processor to perform operations comprising: delivering a series of SCS pulses to nerve tissue of interest, the series of SCS pulses configured to form a plurality of SCS waveforms in accordance with SCS therapy parameters, wherein the SCS pulses are delivered to the nerve tissue of interest via at least one lead electrode of a lead coupleable to the IPG, the at least one lead electrode configured to be implanted at a target position proximate to or within the nerve tissue of interest; determining an evoked compound action potential (ECAP) amplitude based on an ECAP waveform resulting from the SCS pulses; increasing one or more of the SCS therapy parameters; iteratively repeating the delivering, determining and increasing until the ECAP amplitude exhibits a downward trend divergence; and defining a stimulation threshold based on the ECAP amplitude at the downward trend divergence. ### Claim 11 (depends on 10) The IPG of claim 10, wherein the SCS therapy parameters comprise an amplitude of the SCS pulses, a pulse width of the SCS pulses, and a number of the SCS pulses. ### Claim 12 (depends on 10) The IPG of claim 10, the operations further comprising: determining the ECAP amplitude based on a peak during a predetermined time period of the ECAP waveform with respect to a baseline. ### Claim 13 (depends on 10) The IPG of claim 10, the operations further comprising: defining the stimulation threshold based on a combination of electrical characteristics of the SCS pulses at the trend divergence in addition to the ECAP amplitude. ### Claim 14 (depends on 10) The IPG of claim 10, the operations further comprising: transmitting, by communication circuitry of the IPG, an alert notification indicating that the stimulation threshold is defined. ### Claim 15 (depends on 10) The IPG of claim 10, the operations further comprising: after defining the stimulation threshold, delivering a series of SCS pulses that have an amplitude at or below the stimulation threshold.