# US 2014/0194946 A1 · Portable TENS Apparatus And Method Of Use Thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0194946 A1 - Document ID: US20140194946A1 - Status: Published application - Kind: A1 - Application number: 13/738,610 - Filed: 2013-01-10 - Published: 2014-07-10 - Earliest claimed: 2013-01-10 - Assignees: Modular Therapeutx, LLC - Applicants: Modular Therapeutx, LLC - Inventors: Charles M. Thomas; D. Keith Hagy; Donald Kay Riker; Nathan Anderson Pollock; Brad Peter Ryan; Lee Anthony Rodezno; Troy Christiaan Nyssen - Web page: https://patentgrep.com/patent/US20140194946A1 ## CPC - A61N 1/36021: {for treatment of pain} - A61N 1/36034: {specified by the stimulation parameters} - A61N 1/025: {Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors} - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - 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 A TENS apparatus includes a portable TENS device having a housing with a lower surface, a pair of integral electrodes that are incorporated in the lower surface of the housing, and a pulse driver that is located within the housing and adapted to generate a program of pulse waveforms, each of which is an asymmetrical biphasic square waveform. ## Claims ### Claim 1 A TENS apparatus comprising a portable TENS device comprising: (a) a housing having a lower surface; (b) a pair of integral electrodes that are incorporated in the lower surface of the housing; (c) a pulse driver that is located within the housing and adapted to generate a program of pulse waveforms: (i) each of which comprises an asymmetrical biphasic square waveform; (ii) which comprises a first stage period of gate-control theory electrical current therapy for pain relief in a first stage, followed by a second stage period of opiate release theory electrical current therapy for pain relief in a second stage and a third stage period of gate-control theory electrical current therapy for pain relief in a third stage. ### Claim 2 (depends on 1) The TENS apparatus of claim 1 wherein the pulse waveforms that are generated by the pulse driver of the portable TENS device are characterized by a positive pulse followed by a negative pulse that is of a different shape. ### Claim 3 (depends on 1) The TENS apparatus of claim 1 which includes a pair of removable and replaceable conductive hydrogel pads that are sized and shaped to conform to the size and shape of the integral electrodes, said hydrogel pads being adapted to adhesively attach the portable TENS device to the skin of a user. ### Claim 4 (depends on 1) The TENS apparatus of claim 1 wherein the area of the portion of the lower surface of the housing of the portable TENS device that is occupied by the integral electrodes is at least about 50% of the total area of the lower surface of the housing. ### Claim 5 (depends on 1) The TENS apparatus of claim 1 wherein the area of the portion of the lower surface of the housing of the portable TENS device that is occupied by the integral electrodes is at least about 70% of the total area of the lower surface of the housing. ### Claim 6 (depends on 1) The TENS apparatus of claim 1: (a) wherein the portable TENS device includes: (i) a power management component for providing power to the pulse driver; (ii) a user interface component for providing feedback about the operation of the portable TENS device to a user; (iii) a wireless transceiver component; (iv) a microcontroller component for controlling the operation of the pulse driver; (b) which includes a remote controller that is adapted to communicate with the wireless transceiver component of the portable TENS device. ### Claim 7 (depends on 6) The TENS apparatus of claim 6 wherein the microcontroller component of the portable TENS device includes an analog-to-digital converter that is adapted and configured to improve power efficiency in the operation of the TENS device. ### Claim 8 (depends on 6) The TENS apparatus of claim 6 wherein the microcontroller component of the portable TENS device includes an analog-to-digital converter that is adapted and configured to allow for an automatic shutdown of the portable TENS device if the user removes the device from contact with his/her body. ### Claim 9 (canceled) ### Claim 10 A portable TENS apparatus comprising: (a) a housing having a lower surface; (b) a pair of integral electrodes that are incorporated in the lower surface of the housing; (c) a pulse driver that is located within the housing and adapted to generate a program of pulse waveforms, each of which comprises an asymmetrical biphasic square waveform, wherein the program of pulse waveforms comprises a first stage period of gate-control theory electrical current therapy for pain relief in a first stage, followed by a second stage period of opiate release theory electrical current therapy for pain relief in a second stage and a third stage period of gate-control theory electrical current therapy for pain relief in a third stage, wherein: (d) in stage one: (i) the waveform is applied in pulsed modulated frequencies ranging between 80 Hz and 120 Hz; (ii) the frequency modulation time is sixteen seconds; (iii) the frequency change interval is one second; (iv) the pulse width is 120 μsec; (v) the frequency of the waveform ramps up over a period of sixteen seconds from 80 Hz to 120 Hz, and then ramps down over a period of sixteen seconds from 120 Hz to 80 Hz, with this ramp-up and ramp-down sequence being repeated over a first stage period of five minutes, with the ending frequency being 110 Hz; (e) between stage one and stage two, the frequency of the waveform ramps down during a first intermediate period of fourteen seconds from 110 Hz to 5 Hz, with the pulse width remaining at 120 μsec; (f) in stage two: (i) the waveform is applied in pulsed modulated frequencies ranging between 5 Hz and 10 Hz; (ii) the frequency modulation time is five seconds; (iii) the frequency change interval is one second; (iv) the pulse width is 240 μsec; (v) the frequency of the waveform ramps up over a period of five seconds from 5 Hz to 10 Hz and then ramps down over a period of five seconds from 10 Hz to 5 Hz, with this ramp-up and ramp-down sequence being repeated over a second stage period of twenty minutes, with the ending frequency being 5 Hz; (g) between stage two and stage three, the frequency of the waveform ramps up from 5 Hz to 80 Hz during a second intermediate period of thirteen seconds, with the pulse width remaining at 240 μsec; (h) in stage three: (i) the waveform is applied in pulsed modulated frequencies ranging between 80 Hz and 120 Hz; (ii) the frequency modulation time is sixteen seconds; (iii) the frequency change interval is one second; (iv) the frequency of the waveform ramps up over a period of sixteen seconds from 80 Hz to 120 Hz, and then ramps down over a period of sixteen seconds from 120 Hz to 80 Hz, with this ramp-up and ramp-down sequence being repeated for a third stage period of five minutes, with the ending frequency being 110 Hz; (i) after stage three, the frequency of the waveform ramps down from 110 Hz to 0 Hz during a third intermediate period of fifteen seconds, with the pulse width remaining at 120 μsec. ### Claim 11 A method of applying TENS therapy to a user which comprises: (a) providing a portable TENS device comprising: (i) a housing having a lower surface; (ii) a pair of integral electrodes that are incorporated in the lower surface of the housing; (iii) a pulse driver that is located within the housing and adapted to generate a program of pulse waveforms, each of which comprises an asymmetrical biphasic square waveform; (b) providing a pair of removable and replaceable conductive hydrogel pads that are sized and shaped to conform to the size and shape of the integral electrodes, said hydrogel pads being adapted to adhesively attach the portable TENS device to the skin of a user; (c) employing the pair of hydrogel pads to adhesively attach the portable TENS device to the skin of a user; (d) activating the pulse drive of the portable TENS device to generate the program of pulse waveforms: (i) each of which comprises an asymmetrical biphasic square waveform; (ii) which comprises a first stage period of gate-control theory electrical current therapy for pain relief in a first stage, followed by a second stage period of opiate release theory electrical current therapy for pain relief in a second stage and a third stage period of gate-control theory electrical current therapy for pain relief in a third stage. ### Claim 12 (depends on 11) The method of claim 11 which includes providing a pair of removable and replaceable conductive hydrogel pads that are sized and shaped to conform to the size and shape of the integral electrodes, wherein the area of the portion of the lower surface of the housing of the portable TENS device that is occupied by the integral electrodes is at least about 50% of the total area of the lower surface of the housing. ### Claim 13 (depends on 11) The method of claim 11 which includes providing a pair of removable and replaceable conductive hydrogel pads that are sized and shaped to conform to the size and shape of the integral electrodes, wherein the area of the portion of the lower surface of the housing of the portable TENS device that is occupied by the integral electrodes is at least about 70% of the total area of the lower surface of the housing. ### Claim 14 (depends on 11) The method of claim 11 which includes providing a portable TENS device including a pulse driver that is adapted to generate waveforms that are characterized by a positive pulse followed by a negative pulse that is of a different shape. ### Claim 15 (canceled) ### Claim 16 (depends on 11) The method of claim 11 which includes providing a portable TENS device including a pulse driver that is adapted to generate a program of pulse waveforms comprising: (a) a first stage in which: (i) the waveform is applied in pulsed modulated frequencies ranging between 80 Hz and 120 Hz; (ii) the frequency modulation time is sixteen seconds; (iii) the frequency change interval is one second; (iv) the pulse width is 120 μsec; (v) the frequency of the waveform ramps up over a period of sixteen seconds from 80 Hz to 120 Hz, and then ramps down over a period of sixteen seconds from 120 Hz to 80 Hz, with this ramp-up and ramp-down sequence being repeated over a first stage period of five minutes, with the ending frequency being 110 Hz; (b) a first intermediate stage following the first stage in which the frequency of the waveform ramps down during a first intermediate period of fourteen seconds from 110 Hz to 5 Hz, with the pulse width remaining at 120 μsec; (c) a second stage in which: (i) the waveform is applied in pulsed modulated frequencies ranging between 5 Hz and 10 Hz; (ii) the frequency modulation time is five seconds; (iii) the frequency change interval is one second; (iv) the pulse width is 240 μsec; (v) the frequency of the waveform ramps up over a period of five seconds from 5 Hz to 10 Hz and then ramps down over a period of five seconds from 10 Hz to 5 Hz, with this ramp-up and ramp-down sequence being repeated over a second stage period of twenty minutes, with the ending frequency being 5 Hz; (d) a second intermediate stage in which the frequency of the waveform ramps up from 5 Hz to 80 Hz during a second intermediate period of thirteen seconds, with the pulse width remaining at 240 μsec; (e) a third stage in which: (i) the waveform is applied in pulsed modulated frequencies ranging between 80 Hz and 120 Hz; (ii) the frequency modulation time is sixteen seconds; (iii) the frequency change interval is one second; (iv) the frequency of the waveform ramps up over a period of sixteen seconds from 80 Hz to 120 Hz, and then ramps down over a period of sixteen seconds from 120 Hz to 80 Hz, with this ramp-up and ramp-down sequence being repeated for a third stage period of five minutes, with the ending frequency being 110 Hz; (f) a third intermediate stage in which the frequency of the waveform ramps down from 110 Hz to 0 Hz during a third intermediate period of fifteen seconds, with the pulse width remaining at 120 μsec. ### Claim 17 (depends on 1) The TENS apparatus of claim 1 wherein the program of pulse waveforms comprises: (a) a first stage in which the waveform is applied in pulsed modulated frequencies ranging between 80 Hz and 120 Hz; (b) a second stage in which the waveform is applied in pulsed modulated frequencies ranging between 5 Hz and 10 Hz; and (c) a third stage in which the waveform is applied in pulsed modulated frequencies ranging between 80 Hz and 120 Hz.