# US 2013/0158627 A1 · Apparatus and method for relieving pain using transcutaneous electrical nerve stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158627 A1 - Document ID: US20130158627A1 - Status: Published application - Kind: A1 - Application number: 13/678,221 - Filed: 2012-11-15 - Published: 2013-06-20 - Earliest claimed: 2011-11-15 - Assignees: NeuroMetrix, Inc. - Inventors: Shai N. Gozani; Xuan Kong; Andres Aguirre; Glenn Herb; Marc Cryan; Michael Williams - Web page: https://patentgrep.com/patent/US20130158627A1 ## CPC - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - 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 1/321: {Electromedical belts} - A61N 1/36021: {for treatment of pain} - A61N 1/36034: {specified by the stimulation parameters} - A61N 1/37247: {User interfaces, e.g. input or presentation means} - A61N 1/36031: {using physiological parameters for adjustment} - 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 Apparatus for transcutaneous electrical nerve stimulation in humans, comprising a housing; stimulation means mounted within the housing for electrically stimulating nerves; an electrode array releasably mounted to the housing, connectable to the stimulation means, and comprising electrodes for electrical stimulation of nerves; control means mounted to the housing and electrically connected to the stimulation means for controlling the stimulation means; monitoring means mounted to the housing and electrically connected to the stimulation means for monitoring the stimulation means; user interface means mounted to the housing and electrically connected to the control means for controlling the stimulation means; display means mounted to the housing and electrically connected to the control means and the monitoring means for displaying the status of the stimulations means; and a strap attached to the housing and configured to hold the housing, stimulation means and electrode array at a specific anatomical location to treat pain. ## Claims ### Claim 1 Apparatus for transcutaneous electrical nerve stimulation in humans, the apparatus comprising: a housing; stimulation means mounted within the housing for electrically stimulating nerves; an electrode array releasably mounted to the housing and connectable to the stimulation means, the electrode array comprising a plurality of electrodes for electrical stimulation of nerves; control means mounted to the housing and electrically connected to the stimulation means for controlling at least one characteristic of the stimulation means; monitoring means mounted to the housing and electrically connected to the stimulation means for monitoring at least one characteristic of the stimulation means; user interface means mounted to the housing and electrically connected to the control means for controlling the stimulation means; display means mounted to the housing and electrically connected to the control means and the monitoring means for displaying the status of the stimulations means; and a strap attached to the housing; wherein the strap is configured to hold the housing, stimulation means and electrode array at a specific anatomical location to treat pain. ### Claim 2 (depends on 1) Apparatus according to claim 1 wherein said anatomical location is the upper calf area of a patient. ### Claim 3 (depends on 1) Apparatus according to claim 1 wherein said pain is chronic pain. ### Claim 4 (depends on 3) Apparatus according to claim 3 wherein said chronic pain is caused by painful diabetic neuropathy. ### Claim 5 (depends on 1) Apparatus according to claim 1 wherein the housing comprises at least one compartment. ### Claim 6 (depends on 5) Apparatus according to claim 5 wherein the housing comprises a plurality of compartments which are mechanically connected by hinged means so as to allow conforming placement of the housing on a curved portion of human anatomy. ### Claim 7 (depends on 5) Apparatus according to claim 5 wherein the housing comprises a plurality of compartments which are electrically connected so as to allow physical distribution of electrical components. ### Claim 8 (depends on 7) Apparatus according to claim 7 wherein one compartment contains a stimulation circuit of the stimulation means and a second compartment contains a battery that supplies power to the stimulation circuit. ### Claim 9 (depends on 1) Apparatus according to claim 1 wherein the housing contains an interface port for connection to external devices. ### Claim 10 (depends on 9) Apparatus according to claim 9 wherein the interface port is located on the side of the housing facing the anatomy to be stimulated. ### Claim 11 (depends on 10) Apparatus according to claim 10 wherein the interface port is not accessible when the housing is positioned on the patient. ### Claim 12 (depends on 10) Apparatus according to claim 10 wherein the interface port is covered by the electrode array when the apparatus is electrically stimulating nerves. ### Claim 13 (depends on 9) Apparatus according to claim 9 wherein the interface port is a USB port. ### Claim 14 (depends on 1) Apparatus according to claim 1 wherein the stimulation means generates continuous electrical pulses. ### Claim 15 (depends on 14) Apparatus according to claim 14 wherein the stimulation means has a maximum output voltage of 100 volts. ### Claim 16 (depends on 14) Apparatus according to claim 14 wherein the stimulation means has a maximum output current of 100 milliamps. ### Claim 17 (depends on 14) Apparatus according to claim 14 wherein the electrical pulses are current regulated. ### Claim 18 (depends on 14) Apparatus according to claim 14 wherein the electrical pulses are voltage regulated. ### Claim 19 (depends on 14) Apparatus according to claim 14 wherein the electrical pulses have a symmetrical, biphasic and rectangular shape. ### Claim 20 (depends on 19) Apparatus according to claim 19 wherein the two phases of the electrical pulse are charge balanced. ### Claim 21 (depends on 19) Apparatus according to claim 19 wherein each phase of the electrical pulse has a duration of 100 microseconds. ### Claim 22 (depends on 19) Apparatus according to claim 19 wherein there is a 30 microsecond delay between the first and second phases of the electrical pulse. ### Claim 23 (depends on 14) Apparatus according to claim 14 wherein the electrical pulses have a fixed occurrence frequency. ### Claim 24 (depends on 14) Apparatus according to claim 14 wherein the electrical pulses have an occurrence frequency that varies randomly. ### Claim 25 (depends on 24) Apparatus according to claim 24 wherein the frequency varies randomly between 60 and 100 Hz with a uniform distribution. ### Claim 26 (depends on 1) Apparatus according to claim 1 wherein the at least one characteristic of the stimulation means controlled by the control means includes stimulation intensity. ### Claim 27 (depends on 1) Apparatus according to claim 1 wherein the at least one characteristic of the stimulation means controlled by the control means includes the duration of the stimulation session. ### Claim 28 (depends on 27) Apparatus according to claim 27 wherein the duration of the stimulation session is 60 minutes. ### Claim 29 (depends on 1) Apparatus according to claim 1 wherein the at least one characteristic of the stimulation means monitored by the monitoring means includes the stimulation current passing through the electrodes of the electrode array during an electrical pulse. ### Claim 30 (depends on 1) Apparatus according to claim 1 wherein the at least one characteristic of the stimulation means monitored by the monitoring means includes the voltage at the electrodes serving as the cathode of the electrode array before, during, and after an electrical pulse. ### Claim 31 (depends on 1) Apparatus according to claim 1 wherein the at least one characteristic of the stimulation means monitored by the monitoring means includes the voltage at the electrodes serving as the anode of the electrode array before, during, and after an electrical pulse. ### Claim 32 (depends on 1) Apparatus according to claim 1 wherein the at least one characteristic of the stimulation means monitored by the monitoring means includes the bioimpedance of the electrodes serving as the cathode and anode of the electrode array during an electrical pulse. ### Claim 33 (depends on 1) Apparatus according to claim 1 wherein the at least one characteristic of the stimulation means monitored by the monitoring means includes the charge passed through the electrodes of the electrode array during an electrical pulse. ### Claim 34 (depends on 1) Apparatus according to claim 1 wherein the user interface means includes a push button. ### Claim 35 (depends on 34) Apparatus according to claim 34 wherein pressing and holding the push button increases the stimulation intensity as long as the push button is depressed. ### Claim 36 (depends on 35) Apparatus according to claim 35 wherein the stimulation intensity is increased at the rate of 1 milliamp per second. ### Claim 37 (depends on 34) Apparatus according to claim 34 wherein pressing and quickly releasing the push button decreases the stimulation intensity by a fixed amount. ### Claim 38 (depends on 37) Apparatus according to claim 37 wherein stimulation is decreased by 1 milliamp per push button press. ### Claim 39 (depends on 1) Apparatus according to claim 1 wherein the user interface means includes at least one accelerometer. ### Claim 40 (depends on 39) Apparatus according to claim 39 wherein the at least one accelerometer detects patient gestures. ### Claim 41 (depends on 40) Apparatus according to claim 40 wherein a detected patient gesture is a tap to the housing. ### Claim 42 (depends on 41) Apparatus according to claim 41 wherein a tap to the housing immediately stops stimulation. ### Claim 43 (depends on 39) Apparatus according to claim 39 wherein the at least one accelerometer detects orientation of the housing. ### Claim 44 (depends on 43) Apparatus according to claim 43 wherein detected orientation of the housing modifies at least one characteristic of the stimulation means. ### Claim 45 (depends on 39) Apparatus according to claim 39 wherein the at least one accelerometer detects activity level of a patient wearing the housing. ### Claim 46 (depends on 45) Apparatus according to claim 45 wherein the detected activity level modifies at least one characteristic of the stimulation means. ### Claim 47 (depends on 1) Apparatus according to claim 1 wherein the display means comprises at least one LED. ### Claim 48 (depends on 47) Apparatus according to claim 47 wherein the at least one LED indicates that stimulation is ongoing. ### Claim 49 (depends on 47) Apparatus according to claim 47 wherein the at least one LED indicates that stimulation has halted. ### Claim 50 (depends on 47) Apparatus according to claim 47 wherein the at least one LED indicates battery charging status. ### Claim 51 (depends on 1) Apparatus according to claim 1 wherein the strap is configured so that the housing can be attached to calves of different sizes. ### Claim 52 (depends on 1) Apparatus according to claim 1 wherein the strap uses Velcro® to hold the strap at the desired circumference. ### Claim 53 (depends on 1) Apparatus according to claim 1 wherein the strap is replaceable. ### Claim 54 (depends on 53) Apparatus according to claim 53 wherein the strap is selected from a group of different strap sizes so as to accommodate calves of varying sizes. ### Claim 55 (depends on 1) Apparatus according to claim 1 wherein the strap includes a mechanism to assist in stabilizing the electrode array. ### Claim 56 (depends on 1) Apparatus according to claim 1 wherein the strap includes electronic means to measure calf circumference. ### Claim 57 (depends on 56) Apparatus according to claim 56 wherein calf circumference as measured by the strap is communicated to the control means. ### Claim 58 (depends on 57) Apparatus according to claim 57 wherein the at least one characteristic of the stimulation means is modified according to calf circumference. ### Claim 59 (depends on 58) Apparatus according to claim 58 wherein stimulation intensity is modified according to calf circumference. ### Claim 60 Apparatus for providing transcutaneous electrical nerve stimulation to a patient, the apparatus comprising: a housing; stimulation means mounted within the housing for generating electrical pulses; an electrode array releasably mounted to the housing and connectable to the stimulation means, the electrode array comprising a plurality of electrodes for applying the electrical pulse generated by the stimulation means to the skin of a patient; and a strap attached to the housing; wherein the strap is configured to hold the electrode array against the skin of the patient so as to treat pain when the stimulation means generates electrical pulses. ### Claim 61 Electrode array for transcutaneous electrical nerve stimulation in humans, the electrode array comprising: a substrate; at least one electrode mounted to the substrate representing a cathode; at least one electrode mounted to the substrate representing an anode; connection means for connecting the electrodes representing the cathode and anode to electrical stimulation means for electrically stimulating nerves; wherein the substrate and the electrodes representing the cathode and anode are designed to provide electrical stimulation at a specific anatomical location and where a minimum distance between electrodes representing the cathode and anode is maintained. ### Claim 62 (depends on 61) Electrode array according to claim 61 wherein said anatomical location is the upper calf area of a patient. ### Claim 63 (depends on 62) Electrode array according to claim 62 wherein, when the electrode array is placed in the upper calf area, electrical stimulation is provided to one or more sensory dermatomes among L4, L5, S1, and S2. ### Claim 64 (depends on 61) Electrode array according to claim 61 wherein the electrode array consists of two pairs of electrically connected electrodes. ### Claim 65 (depends on 61) Electrode array according to claim 61 wherein said connection means comprises a male snap-type connector. ### Claim 66 (depends on 65) Electrode array according to claim 65 wherein, when said male snap-type connector is inserted into a female snap-type connector mounted on a stimulation means, the electrodes representing the cathode and anode are electrically connected to the stimulation means. ### Claim 67 (depends on 65) Electrode array according to claim 65 wherein, when said male snap-type connector is inserted into a female snap-type connector mounted on a stimulation means, a secure mechanical connection is established between the electrodes representing the cathode and anode and the stimulation means. ### Claim 68 (depends on 61) Electrode array according to claim 61 wherein the minimum distance is 40 mm. ### Claim 69 (depends on 61) Electrode array according to claim 61 wherein the electrode array is for use by a single person. ### Claim 70 (depends on 69) Electrode array according to claim 69 wherein the electrode array is for multiple applications over a period of time. ### Claim 71 A method for determining a therapeutic stimulation intensity for transcutaneous electrical nerve stimulation in humans, the method comprising the steps of: automatically increasing the stimulation intensity from a first stimulation intensity; identifying at least one electrotactile perception threshold; and calculating a therapeutic stimulation intensity from said at least one electrotactile perception threshold. ### Claim 72 (depends on 71) A method according to claim 71 wherein said at least one of said electrotactile perception thresholds comprises the electrotactile sensation threshold. ### Claim 73 (depends on 72) A method according to claim 72 wherein the electrotactile sensation threshold is determined by the patient indicating the stimulation intensity at which stimulation is first perceived. ### Claim 74 (depends on 71) A method according to claim 71 wherein said at least one of said electrotactile perception thresholds comprises the electrotactile pain threshold. ### Claim 75 (depends on 74) A method according to claim 74 wherein the electrotactile pain threshold is determined by the patient indicating the stimulation intensity at which stimulation first becomes painful. ### Claim 76 (depends on 71) A method according to claim 71 wherein the first stimulation intensity is 0 milliamps. ### Claim 77 (depends on 71) A method according to claim 71 wherein the first stimulation intensity is 50% of a previously measured sensation threshold. ### Claim 78 (depends on 71) A method according to claim 71 wherein the first stimulation intensity is 10 milliamps lower than the previously measured sensation threshold. ### Claim 79 (depends on 71) A method according to claim 71 wherein the automatic increase in stimulation intensity is at a constant rate. ### Claim 80 (depends on 79) A method according to claim 79 wherein the constant rate is 1 milliamp per second. ### Claim 81 (depends on 71) A method according to claim 71 wherein the automatic increase in stimulation intensity is at a geometric rate. ### Claim 82 (depends on 81) A method according to claim 81 wherein the geometric rate is 1.05. ### Claim 83 (depends on 81) A method according to claim 81 wherein the amount of increase in stimulation intensity is bounded by a minimum and maximum value. ### Claim 84 (depends on 83) A method according to claim 83 wherein the minimum value is 0.5 milliamps. ### Claim 85 (depends on 83) A method according to claim 83 wherein the maximum value is 2 milliamps. ### Claim 86 (depends on 71) A method according to claim 71 wherein the automatic increase in stimulation intensity is initiated by patient interaction with a push button. ### Claim 87 (depends on 71) A method according to claim 71 wherein the electrotactile perception threshold is indicated by patient interaction with a push button. ### Claim 88 (depends on 71) A method according to claim 71 wherein the electrotactile perception threshold is indicated by a patient gesture detected by an accelerometer. ### Claim 89 (depends on 88) A method according to claim 88 wherein said patient gesture is tapping a stimulator enclosure. ### Claim 90 (depends on 71) A method according to claim 71 wherein the therapeutic stimulation intensity is determined by identifying the stimulation intensity associated with the electrotactile sensation threshold, and then adjusting that stimulation intensity by an offset. ### Claim 91 (depends on 90) A method according to claim 90 wherein the offset is added to the stimulation intensity associated with the electrotactile sensation threshold so as to determine the therapeutic stimulation intensity. ### Claim 92 (depends on 71) A method according to claim 71 wherein the calculation step comprises multiplying the sensation threshold by a multiplicative factor. ### Claim 93 (depends on 92) A method according to claim 92 wherein the multiplicative factor is 2. ### Claim 94 (depends on 92) A method according to claim 92 wherein the multiplicative factor is a function of demographic factors. ### Claim 95 (depends on 94) A method according to claim 94 wherein the demographic factors include patient age, gender, weight, and height. ### Claim 96 (depends on 92) A method according to claim 92 wherein the multiplicative factor is a function of biometric factors. ### Claim 97 (depends on 96) A method according to claim 96 wherein the biometric factors include the patient's calf circumference. ### Claim 98 (depends on 92) A method according to claim 92 wherein the multiplicative factor is a function of physiological factors. ### Claim 99 (depends on 98) A method according to claim 98 wherein the physiological factors include skin surface temperature, galvanic skin response, electromyographic activity, and bioimpedance. ### Claim 100 (depends on 92) A method according to claim 92 wherein the multiplicative factor is a function of at least one previously determined sensation thresholds. ### Claim 101 (depends on 92) A method according to claim 92 wherein the multiplicative factor is a function of at least one previously used stimulation intensities. ### Claim 102 (depends on 71) A method according to claim 71 wherein the therapeutic stimulation intensity is calculated from a plurality of measurements of sensation threshold. ### Claim 103 (depends on 102) A method according to claim 102 wherein the therapeutic stimulation intensity is calculated from the average of a plurality of sensation thresholds. ### Claim 104 (depends on 102) A method according to claim 102 wherein the therapeutic stimulation intensity is calculated from the median of the plurality of sensation thresholds. ### Claim 105 A method for determining a therapeutic stimulation intensity for transcutaneous electrical nerve stimulation in a patient, the method comprising the steps of: applying electrical stimulation to the patient at a first stimulation intensity; automatically increasing the intensity of the electrical stimulation applied to the patient from the first stimulation intensity to a second intensity at which the electrotactile sensation threshold is identified; and calculating a therapeutic stimulation intensity from said second intensity level. ### Claim 106 A method for treating pain in a patient using transcutaneous electrical nerve stimulation, the method comprising the steps of: automatically determining a therapeutic stimulation intensity; initiating electrical stimulation at the therapeutic stimulation intensity; adjusting the therapeutic stimulation intensity under patient control; automatically increasing the therapeutic stimulation intensity at a pre-determined rate; and continuing electrical stimulation for a period of time. ### Claim 107 (depends on 106) A method according to claim 106 wherein the pain is chronic pain. ### Claim 108 (depends on 106) A method according to claim 106 wherein the chronic pain is caused by painful diabetic neuropathy. ### Claim 109 (depends on 106) A method according to claim 106 wherein the therapeutic stimulation intensity is automatically increased to overcome the effects of nerve habituation. ### Claim 110 (depends on 106) A method according to claim 106 wherein the therapeutic stimulation intensity is automatically increased by a multiplicative factor at a fixed interval. ### Claim 111 (depends on 110) A method according to claim 110 wherein the multiplicative factor for therapy sessions is modified according to a target stimulation intensity level as projected by a default multiplicative factor, an actual stimulation intensity level as controlled by a patient, and the difference between these intensity levels at various time intervals as observed in previous therapy sessions. ### Claim 112 (depends on 110) A method according to claim 110 wherein the default multiplicative factor is 1.004 and the fixed interval is 1 minute. ### Claim 113 (depends on 106) A method according to claim 106 wherein the therapeutic stimulation intensity is automatically increased by a fixed amount at a fixed interval. ### Claim 114 (depends on 106) A method according to claim 106 wherein the period of time is the lesser of 60 minutes and a lower value due to a stimulation exit event. ### Claim 115 (depends on 114) A method according to claim 114 wherein a stimulation exit event is triggered by a patient action. ### Claim 116 (depends on 115) A method according to claim 115 wherein the patient action is tapping the housing of an electrical stimulator. ### Claim 117 (depends on 114) A method according to claim 114 wherein a stimulation exit event is triggered by a stimulation error condition. ### Claim 118 (depends on 117) A method according to claim 117 wherein the stimulation error is the occurrence of a stimulation current during an electrical pulse which is smaller than the target current intensity. ### Claim 119 (depends on 117) A method according to claim 117 wherein the stimulation error is high bioimpedance between electrodes delivering the electrical stimulation. ### Claim 120 (depends on 117) A method according to claim 117 wherein the stimulation error is a large change in bioimpedance between the electrodes delivering the electrical stimulation. ### Claim 121 (depends on 120) A method according to claim 120 wherein said large change is a 50% change within 60 minutes. ### Claim 122 (depends on 117) A method according to claim 117 wherein the stimulation error is the removal from the patient's skin of the electrodes delivering the electrical stimulation. ### Claim 123 (depends on 117) A method according to claim 117 wherein the stimulation error is where the electrical charge delivered during the electrical stimulation is smaller or larger than a target electrical charge.