# US 10,864,365 B2 · Transcutaneous electrical nerve stimulation using novel unbalanced biphasic waveform and novel electrode arrangement > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,864,365 B2 - Document ID: US10864365B2 - Status: Granted - Kind: B2 - Application number: 16/175,212 - Filed: 2018-10-30 - Published: 2019-07-04 - Granted: 2020-12-15 - Earliest claimed: 2011-11-15 - Assignees: NeuroMetrix, Inc. - Applicants: Neurometrix, Inc. - Inventors: Glenn Herb; Andres Aguirre; Xuan Kong; Shai N. Gozani - Web page: https://patentgrep.com/patent/US10864365B2 ## CPC - A61N 1/0452: {Specially adapted for transcutaneous muscle stimulation [TMS]} - A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)} - A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)} - A61N 1/36034: {specified by the stimulation parameters} - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - A61N 1/321: {Electromedical belts} - A61N 1/36021: {for treatment of pain} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - 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 The present invention is directed to transcutaneous electrical nerve stimulation (TENS) devices which utilize novel stimulation waveforms and novel arrangements of TENS electrodes to improve the efficiency of power consumption while enhancing therapeutic effects. ## Claims ### Claim 1 Apparatus for providing transcutaneous electrical nerve stimulation to a user, said apparatus comprising: a stimulation unit for electrically stimulating nerves using asymmetric biphasic electrical pulses, wherein during the first phase and the second phase of an asymmetric biphasic electrical pulse, said stimulation unit generates a voltage at an anode that is higher than a voltage at a cathode so as to allow current to flow from the anode to the cathode, and wherein said stimulation unit delivers a larger amount of electrical charge in the second phase of the asymmetric biphasic electrical pulse than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage setting in both phases of the asymmetric biphasic electrical pulse to deliver the same current intensity by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse; a control unit for controlling the electrical stimulation delivered by said stimulation unit; and an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on one location of the user's body, said first electrode overlays a first nerve underneath the electrode array but not a second nerve underneath the electrode array and said second electrode overlays the second nerve underneath the electrode array but not the first nerve underneath the electrode array; whereby, the first electrode activates the first nerve during the first phase of the asymmetric biphasic electrical pulse and the second electrode activates the second nerve during the second phase of the asymmetric biphasic electrical pulse. ### Claim 2 (depends on 1) Apparatus according to claim 1 wherein said control unit is configured to cause said stimulation unit to deliver discrete asymmetric biphasic electrical pulses. ### Claim 3 (depends on 2) Apparatus according to claim 2 wherein the discrete asymmetric biphasic electrical pulses are current-regulated. ### Claim 4 (depends on 2) Apparatus according to claim 2 wherein the polarity of the first phase of the discrete asymmetric biphasic electrical pulses varies. ### Claim 5 (depends on 4) Apparatus according to claim 4 wherein the polarity of the first phase of each discrete asymmetric biphasic electrical pulse varies so as to ensure that an equal amount of positive and negative charges flow into each electrode within a predetermined time period. ### Claim 6 (depends on 2) Apparatus according to claim 2 wherein the discrete asymmetric biphasic electrical pulses are delivered at a constant frequency. ### Claim 7 (depends on 2) Apparatus according to claim 2 wherein the discrete asymmetric biphasic electrical pulses are delivered at a random frequency. ### Claim 8 (depends on 1) Apparatus according to claim 1 wherein said apparatus is powered by a portable power source. ### Claim 9 (depends on 1) Apparatus according to claim 1 wherein said electrode array comprises a third electrode and a fourth electrode, said third electrode and said fourth electrode being mounted to said substrate with a predetermined arrangement, so that said third electrode overlays the first nerve underneath the electrode array but not the second nerve underneath the electrode array and said fourth electrode overlays the second nerve underneath the electrode array but not the first nerve underneath the electrode array. ### Claim 10 (depends on 1) Apparatus according to claim 1 wherein said control unit controls the anode voltage of said stimulation unit. ### Claim 11 (depends on 10) Apparatus according to claim 10 wherein said control unit controls said anode voltage based on at least one of the following: (i) the cathode voltage, and (ii) measurements of the asymmetric biphasic electrical pulses. ### Claim 12 (depends on 1) Apparatus according to claim 1 wherein said control unit controls the amplitude and duration of the first and second phases of the asymmetric biphasic electrical pulses. ### Claim 13 Apparatus for providing transcutaneous electrical nerve stimulation to a user, said apparatus comprising: a stimulation unit for electrically stimulating nerves using asymmetric biphasic electrical pulses, wherein during the first phase and the second phase of an asymmetric biphasic electrical pulse, said stimulation unit generates a voltage at an anode that is higher than a voltage at a cathode so as to allow current to flow from the anode to the cathode, and wherein said stimulation unit delivers a larger amount of electrical charge in the second phase of the asymmetric biphasic electrical pulse than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage setting in both phases of the asymmetric biphasic electrical pulse by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse; a control unit for controlling the electrical stimulation delivered by said stimulation unit; and an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on one location of the user's body, said first electrode overlays a first nerve underneath the electrode array but not a second nerve underneath the electrode array and said second electrode overlays the second nerve underneath the electrode array but not the first nerve underneath the electrode array; whereby, the first electrode activates the first nerve during the first phase of the asymmetric biphasic electrical pulse and the second electrode activates the second nerve during the second phase of the asymmetric biphasic electrical pulse. ### Claim 14 (depends on 13) Apparatus according to claim 13 wherein said control unit is configured to cause said stimulation unit to deliver discrete asymmetric biphasic electrical pulses. ### Claim 15 (depends on 14) Apparatus according to claim 14 wherein the discrete asymmetric biphasic electrical pulses are current-regulated. ### Claim 16 (depends on 14) Apparatus according to claim 14 wherein the amplitude of the second phase of said asymmetric biphasic electrical pulses is the same as the amplitude of the first phase of said asymmetric biphasic electrical pulses. ### Claim 17 (depends on 14) Apparatus according to claim 14 wherein the amplitude of the second phase of said asymmetric biphasic electrical pulses is greater than the amplitude of the first phase of said asymmetric biphasic electrical pulses. ### Claim 18 (depends on 14) Apparatus according to claim 14 wherein the duration of the second phase of said asymmetric biphasic electrical pulses is the same as the duration of the first phase of said asymmetric biphasic electrical pulses. ### Claim 19 (depends on 14) Apparatus according to claim 14 wherein the duration of the second phase of said asymmetric biphasic electrical pulses is greater than the duration of the first phase of said asymmetric biphasic electrical pulses. ### Claim 20 (depends on 13) Apparatus according to claim 13 wherein said electrode array comprises a third electrode and a fourth electrode, said third electrode and said fourth electrode being mounted to said substrate with a predetermined arrangement, so that said third electrode overlays the first nerve underneath the electrode array but not the second nerve underneath the electrode array and said fourth electrode overlays the second nerve underneath the electrode array but not the first nerve underneath the electrode array. ### Claim 21 (depends on 13) Apparatus according to claim 13 wherein said control unit controls the anode voltage of said stimulation unit. ### Claim 22 (depends on 21) Apparatus according to claim 21 wherein said control unit controls said anode voltage based on at least one of the following: (i) the cathode voltage, and (ii) measurements of the asymmetric biphasic electrical pulses. ### Claim 23 (depends on 13) Apparatus according to claim 13 wherein said control unit controls the amplitude and duration of the first and second phases of the asymmetric biphasic electrical pulses. ### Claim 24 A method for providing transcutaneous electrical nerve stimulation therapy to a user, said method comprising: providing a stimulation unit for generating asymmetric biphasic electrical pulses, wherein the asymmetric biphasic electrical pulses are generated by creating a voltage difference between an anode voltage and a cathode voltage, and the amount of electrical charge delivered in the second phase of an asymmetric biphasic electrical pulse is larger than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage during the first and second phases of the asymmetric biphasic electrical pulse to deliver the same current intensity by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse; providing an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on one location of the user's body, said first electrode overlays a first nerve underneath the electrode array but not a second nerve underneath the electrode array and said second electrode overlays the second nerve underneath the electrode array but not the first nerve underneath the electrode array; and using said stimulation unit and said electrode array to apply asymmetric biphasic electrical pulses to the skin of a user, whereby, the first electrode activates the first nerve during the first phase of the asymmetric biphasic electrical pulse and the second electrode activates the second nerve during the second phase of the asymmetric biphasic electrical pulse. ### Claim 25 (depends on 24) A method according to claim 24 wherein the asymmetric biphasic electrical pulses are delivered at a constant frequency. ### Claim 26 (depends on 24) A method according to claim 24 wherein the asymmetric biphasic electrical pulses are delivered at a random frequency, wherein said random frequency is within a predetermined range. ### Claim 27 (depends on 24) A method according to claim 24 wherein the first and second phases of the asymmetric biphasic electrical pulses are separated by a time delay. ### Claim 28 (depends on 24) A method according to claim 24 wherein the asymmetric biphasic electrical pulses vary the polarity of the first phase of the asymmetric biphasic electrical pulses. ### Claim 29 (depends on 28) A method according to claim 28 wherein the first phase of the asymmetric biphasic electrical pulses alternates with every asymmetric biphasic electrical pulse. ### Claim 30 (depends on 28) A method according to claim 28 wherein the pattern of alternations of the first phases of the asymmetric biphasic electrical pulses ensures that an equal amount of positive and negative charges flow into each electrode within a predetermined time period. ### Claim 31 (depends on 24) A method according to claim 24 wherein the amplitude of the two phases of the asymmetric biphasic electrical pulses are independently controlled. ### Claim 32 (depends on 24) A method according to claim 24 wherein the duration of the two phases of the asymmetric biphasic electrical pulses are independently controlled. ### Claim 33 (depends on 24) A method according to claim 24 wherein the anode voltage of said stimulation unit is controllable. ### Claim 34 (depends on 24) A method according to claim 24 wherein the cathode voltage of said stimulation unit is controllable. ### Claim 35 (depends on 33) A method according to claim 33 wherein the anode voltage is powered by an energy source with an output voltage lower than the anode voltage. ### Claim 36 (depends on 33) A method according to claim 33 wherein the anode voltage is controlled to a target value. ### Claim 37 (depends on 36) A method according to claim 36 wherein said target value for the anode voltage is adjusted so that the cathode voltage is within a desired range. ### Claim 38 A method for providing transcutaneous electrical nerve stimulation therapy to a user, said method comprising: providing a stimulation unit for generating asymmetric biphasic electrical pulses, wherein the asymmetric biphasic electrical pulses are generated by creating a voltage difference between an anode voltage and a cathode voltage, and the amount of electrical charge delivered in the second phase of an asymmetric biphasic electrical pulse is larger than the amount of electrical charge delivered in the first phase of the asymmetric biphasic electrical pulse using the same anode voltage during the first and second phases of the asymmetric biphasic electrical pulse by taking advantage of the electrical charge accumulated during the first phase of the asymmetric biphasic electrical pulse; providing an electrode array connectable to said stimulation unit, said electrode array comprising a substrate and at least first and second electrodes, the at least first and second electrodes being mounted to said substrate with a predetermined arrangement, so that when said substrate is placed on one location of the user's body, said first electrode overlays a first nerve underneath the electrode array but not a second nerve underneath the electrode array and said second electrode overlays the second nerve underneath the electrode array but not the first nerve underneath the electrode array; and using said stimulation unit and said electrode array to apply asymmetric biphasic electrical pulses to the skin of a user, whereby, the first electrode activates the first nerve during the first phase of the asymmetric biphasic electrical pulse and the second electrode activates the second nerve during the second phase of the asymmetric biphasic electrical pulse. ### Claim 39 (depends on 38) A method according to claim 38 wherein the amplitude of the two phases of the asymmetric biphasic electrical pulses are independently controlled. ### Claim 40 (depends on 39) A method according to claim 39 wherein the amplitude of the second phase of an asymmetric biphasic electrical pulse is larger than the amplitude of the first phase of the asymmetric biphasic electrical pulse. ### Claim 41 (depends on 39) A method according to claim 39 wherein the amplitude of the second phase of an asymmetric biphasic electrical pulse is the same as the amplitude of the first phase of the asymmetric biphasic electrical pulse. ### Claim 42 (depends on 38) A method according to claim 38 wherein the duration of the two phases of the asymmetric biphasic electrical pulses are independently controlled. ### Claim 43 (depends on 42) A method according to claim 42 wherein the duration of the second phase of an asymmetric biphasic electrical pulse is larger than the duration of the first phase of the asymmetric biphasic electrical pulse. ### Claim 44 (depends on 42) A method according to claim 42 wherein the duration of the second phase of an asymmetric biphasic electrical pulse is the same as the duration of the first phase of the asymmetric biphasic electrical pulse.