# US 12,005,250 B2 · Techniques for sensing incorrect lead connection to an implantable stimulator device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,250 B2 - Document ID: US12005250B2 - Status: Granted - Kind: B2 - Application number: 17/387,405 - Filed: 2021-07-28 - Published: 2021-11-18 - Granted: 2024-06-11 - Earliest claimed: 2017-09-12 - Assignees: Boston Scientific Neuromodulation Corporation - Applicants: Boston Scientific Neuromodulation Corporation - Inventors: Kelsey Bower; G. Karl Steinke; Hemant Bokil; Ara Sarian - Web page: https://patentgrep.com/patent/US12005250B2 ## CPC - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/36128: {Control systems} - A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) - A61N 1/0534: {Electrodes for deep brain stimulation} - A61N 1/36: for stimulation - A61N 1/36071: {Pain} - A61N 1/36135: {using physiological parameters} - A61N 1/37211: {Means for communicating with stimulators} - A61N 1/3752: {Details of casing-lead connections} - A61B 5/407: {Evaluating the spinal cord (for locating the epidural space A61B5/4896)} - A61N 1/36062: {Spinal stimulation} - A61N 1/36067: {Movement disorders, e.g. tremor or Parkinson disease (stimulating motor muscle A61N1/36003)} - A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease} - A61N 1/36125: {Details of circuitry or electric components} - A61N 1/36171: {Frequency} - A61N 1/362: Heart stimulators (heart defibrillators A61N1/39) - A61N 1/37241: {providing test stimulations} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion} - A61N 2001/083: {Monitoring integrity of contacts, e.g. by impedance measurement} - 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 Incorrect connection or mapping of leads' proximal terminals to the ports of an Implantable Stimulator Device (ISD), such as an implantable pulse generator or an external trial stimulator, is a concern, and this disclosure is directed to use of measurement and identification algorithms to either determine that leads are properly connected to their assigned ISD ports, or to determine which leads are connected to the ports even if the leads are not preassigned to the ports. Particular focus is given in the disclosed technique to assessing leads that comprise larger number of electrodes than are supported at each port, and thus have more than one proximal terminal that connect to more than one port of the ISD. ## Claims ### Claim 1 A system for assessing a lead comprising a distal end with N electrodes and a plurality I of proximal terminals, the system comprising: an implantable stimulator device (ISD) comprising a plurality of ports, wherein each proximal terminal of the lead is connected to a different one of the ports, each port comprising a plurality of J=N/I device contacts each coupled to one of the electrodes, wherein the ISD is configured to provide stimulation at each of the N electrodes, and measure a parameter at each of the N electrodes in response to the stimulation of each of the N electrodes thus yielding N*N measured parameters; and an external device in communication with the ISD, wherein the external device is configured to receive the measured parameters, determine expected parameters for the measured parameters, and compare the measured parameters and the expected parameters to determine which of the proximal terminals is connected to which of the ports on the ISD. ### Claim 2 (depends on 1) The system of claim 1, wherein the ISD is configured to stimulate each of the N electrodes using a constant current, and wherein the parameter measured at each of the N electrodes comprises a voltage. ### Claim 3 (depends on 2) The system of claim 2, wherein the ISD comprises a case electrode, and wherein the ISD is configured to provide the constant current between each of the N electrodes and the case electrode. ### Claim 4 (depends on 1) The system of claim 1, wherein the external device is further configured to divide the measured parameters into first regions and second regions, wherein each first region corresponds to one of the ports and comprises measured parameters when the J electrodes corresponding to that port are stimulated and measured, and wherein each second region comprises measured parameters when the J electrodes corresponding to a given port are stimulated and when the J electrodes corresponding to a different port are measured. ### Claim 5 (depends on 4) The system of claim 4, wherein external device is configured to determine which of the proximal terminals is connected to which of the ports on the ISD by assessing at least the second regions. ### Claim 6 (depends on 1) The system of claim 1, wherein the external device is further configured to determine a type of the lead. ### Claim 7 (depends on 6) The system of claim 6, wherein the external device is further configured to divide the measured parameters into first regions and second regions, wherein each first region corresponds to one of the ports and comprises measured parameters when the J electrodes corresponding to that port are stimulated and measured, and wherein each second region comprises measured parameters when the J electrodes corresponding to a given port are stimulated and when the J electrodes corresponding to a different port are measured. ### Claim 8 (depends on 7) The system of claim 7, wherein external device is configured to determine the type of the lead by assessing at least the first regions. ### Claim 9 (depends on 6) The system of claim 6, wherein the external device is further configured indicate to a user the determined lead type. ### Claim 10 (depends on 1) The system of claim 1, wherein the external device is further configured indicate to a user the determination of which of the proximal terminals is connected to which of the ports on the ISD. ### Claim 11 (depends on 1) The system of claim 1, wherein the external device is further configured to allow a user to assign the connection of each of the proximal terminals to the ports, and determine whether the determination of which of the proximal terminals is connected to which of the ports on the ISD matches or mismatches the assigned connection of each of the proximal terminals to the ports. ### Claim 12 (depends on 11) The system of claim 11, wherein the external device is further configured, if there is a mismatch, to notify the user of the mismatch. ### Claim 13 (depends on 12) The system of claim 12, wherein the external device is further configured, if there is a mismatch, to provide an option for the user to reassign the assigned connections to match the determination of which of the proximal terminals is connected to which of the ports on the ISD. ### Claim 14 A method for assessing a lead comprising a distal end with a plurality N electrodes and a plurality I of proximal terminals each connected to a different port of an implantable stimulator device (ISD), each port comprising a plurality of J=N/I device contacts each coupled to one of the electrodes, the method comprising: (a) providing from the ISD stimulation at each of the N electrodes; (b) measuring at the ISD a parameter at each of the N electrodes in response to the stimulation of each of the N electrodes thus yielding N*N measured parameters; (c) receiving the measured parameters at an external device in communication with the ISD; (d) determining at the external device expected parameters for the measured parameters; and (e) comparing at the external device the measured parameters and the expected parameters to determine which of the proximal terminals is connected to which of the ports on the ISD. ### Claim 15 (depends on 14) The method of claim 14, wherein the ISD stimulates each of the N electrodes using a constant current, and wherein the parameter measured at each of the N electrodes comprises a voltage. ### Claim 16 (depends on 15) The method of claim 15, wherein the ISD comprises a case electrode, and wherein the ISD is configured to provide the constant current between each of the N electrodes and the case electrode. ### Claim 17 (depends on 14) The method of claim 14, wherein the external device is further configured to determine a type of the lead. ### Claim 18 (depends on 14) The method of claim 14, further comprising indicating on the external device the determination of which of the proximal terminals is connected to which of the ports on the ISD. ### Claim 19 (depends on 14) The method of claim 14, further comprising receiving at the external device a user assignment of the connection of each of the proximal terminals to the ports, and determining whether the determination of which of the proximal terminals is connected to which of the ports on the ISD matches or mismatches the assigned connection of each of the proximal terminals to the ports. ### Claim 20 A non-transitory computer readable medium executable on an external device configured to communicate with an implantable stimulator device (ISD) connected to a lead, the lead comprising a distal end with a plurality N electrodes and a plurality I of proximal terminals each connected to a different port of the ISD, each port comprising a plurality of J=N/I device contacts each coupled to one of the electrodes, wherein the medium includes instructions that when executed on the external device cause the external device to: (a) instruct the ISD to provide stimulation at each of the N electrodes; (b) receive measured parameters form the ISD, wherein the measured parameters comprise a parameter measured at each of the N electrodes in response to the stimulation of each of the N electrodes, thus yielding N*N measured parameters; (c) retrieve expected parameters for the measured parameters; and (d) compare the measured parameters and the expected parameters to determine which of the proximal terminals is connected to which of the ports on the ISD.