# US 2013/0158425 A1 · Apparatus and methods for performing electrotherapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158425 A1 - Document ID: US20130158425A1 - Status: Published application - Kind: A1 - Application number: 13/679,982 - Filed: 2012-11-16 - Published: 2013-06-20 - Earliest claimed: 2011-11-18 - Assignees: Bioelectric Research Corporation, Inc. - Inventors: Steven Michael Kaye; Bryan Thomas Kaye; Davin Carlton Ashraf; Daniel Kemper Walsh; John Vito Biondo - Web page: https://patentgrep.com/patent/US20130158425A1 ## CPC - A61N 1/048: {Electrodes characterised by a specific connection between lead and electrode} - A61B 5/0531: Measuring skin impedance - A61N 1/0408: {Use-related aspects} - A61N 1/0496: {characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives} - A61N 1/32: alternating or intermittent currents {(applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02)} - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - Y10T 156/10: Methods of surface bonding and/or assembly therefor - 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) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract A circumferential electrode includes a moisture-containing layer comprising a first side and an electrically conductive layer on the moisture-containing layer, the electrically conductive layer including a second side and a third side opposite the second side, the third side of the electrically conductive layer contacting the first side of the moisture-containing layer. The circumferential electrode further includes a barrier layer on the electrically conductive layer, the barrier layer including a fourth side adjacent to the second side of the electrically conductive layer. The circumferential electrode further includes a bulk region and a border region, the border region completely surrounding the bulk region, and the electrically conductive layer is in the bulk region but is not in the border region. The circumferential electrode can be part of an electrotherapy system which can be used to apply various current waveforms to patients in order to treat a variety of ailments and conditions. ## Claims ### Claim 1 A circumferential electrode, comprising: a moisture-containing layer comprising a first side; an electrically conductive layer on the moisture-containing layer, the electrically conductive layer including a second side and a third side opposite the second side, the third side of the electrically conductive layer contacting the first side of the moisture-containing layer; and a barrier layer on the electrically conductive layer, the barrier layer including a fourth side adjacent to the second side of the electrically conductive layer. ### Claim 2 (depends on 1) The circumferential electrode of claim 1, wherein the electrically conductive layer directly contacts the moisture-containing layer without any adhesive material being between the electrically conductive layer and the moisture-containing layer. ### Claim 3 (depends on 1) The circumferential electrode of claim 1, wherein the third side of the electrically conductive layer is secured to the first side of the moisture-containing layer with an electrically conductive adhesive material. ### Claim 4 (depends on 1) The circumferential electrode of claim 1, wherein the barrier layer is configured to prevent or suppress fluid escaping the moisture-containing layer. ### Claim 5 (depends on 1) The circumferential electrode of claim 1, wherein the moisture-containing layer comprises a layer of hydrogel. ### Claim 6 (depends on 5) The circumferential electrode of claim 5, wherein the layer of hydrogel includes a first portion comprising hygrogel having a first composition, wherein the first composition is configured to adhere to human skin. ### Claim 7 (depends on 6) The circumferential electrode of claim 6, the first portion further comprising hydrogel having a second composition, wherein the second composition is configured to adhere to the barrier layer. ### Claim 8 (depends on 7) The circumferential electrode of claim 7, wherein the first portion comprises a laminate including the hydrogel having the first composition and the hydrogel having the second composition. ### Claim 9 (depends on 6) The circumferential electrode of claim 6, wherein the layer of hydrogel includes a second portion comprising hygrogel having a third composition, wherein the third composition is configured to adhere to the electrically conductive layer or to the barrier layer. ### Claim 10 (depends on 9) The circumferential electrode of claim 9, wherein the second portion is on an opposite side of the layer of hydrogel from the first portion. ### Claim 11 A method of forming a circumferential electrode, the method comprising: providing a barrier layer comprising a fourth side; attaching an electrically conductive layer comprising a second side and a third side to the barrier layer, the second side being opposite the third side, the second side being adjacent to the fourth side of the barrier layer; and adding a hydrogel layer comprising a first side and a fifth side, the first side being opposite the fifth side, the third side of the electrically conductive layer contacting the first side of the hydrogel layer; wherein the hydrogel layer adheres to the barrier layer or to the electrically conductive layer without requiring an additional adhesive. ### Claim 12 (depends on 11) The method of claim 11, wherein the hydrogel layer includes a first portion adjacent to the first side of the hydrogel layer and a second portion adjacent to the fifth side of the hydrogel layer, the first portion comprising hydrogel having a first composition and the second portion comprising hydrogel having a second composition, wherein the first composition is different from the second composition. ### Claim 13 (depends on 12) The method of claim 12, wherein the hydrogel in the first portion is configured to adhere to the barrier layer or to the electrically conductive layer. ### Claim 14 (depends on 13) The method of claim 13, wherein the hydrogel in the second portion is configured to adhere to human skin. ### Claim 15 (depends on 14) The method of claim 14, wherein the hydrogel in the second portion is further configured to adhere to the barrier layer. ### Claim 16 A method of providing an electric current through a recipient, the method comprising: providing a first electrode and a second electrode, the first and second electrode each contacting the recipient; providing a current generating source connected to each of the first and second electrodes; configuring the current generating source to provide a first electric current in a first direction through the recipient; sensing a first voltage difference between the first electrode and the second electrode to determine a first magnitude of the first voltage difference; comparing the first magnitude to a voltage threshold; and executing a first function; wherein the sensing, the comparing, and the executing are each performed by the current generating source without additional input from an operator or user of the current generating source. ### Claim 17 (depends on 16) The method of claim 16, wherein the sensing and the executing are each performed at least two times over a time span of at least one second. ### Claim 18 (depends on 16) The method of claim 16, wherein executing the first function comprises reconfiguring the current generating source to provide a second electric current in the first direction. ### Claim 19 (depends on 18) The method of claim 18, wherein the first function is executed when the first magnitude is greater than the voltage threshold. ### Claim 20 (depends on 19) The method of claim 19, the sensing and the executing each being performed at least two times over a time span of at least one second, wherein the first magnitude being greater than the voltage threshold comprises the first magnitude exceeding the voltage threshold every time the comparing is performed during the time span. ### Claim 21 (depends on 18) The method of claim 18, the first function being executed after a preprogrammed or predefined time span, wherein the first magnitude is less than the voltage threshold when the first function is executed. ### Claim 22 (depends on 18) The method of claim 18, wherein the second electric current is smaller than the first electric current. ### Claim 23 (depends on 16) The method of claim 16, further comprising executing a second function, the second function being different from the first function, wherein the second function is performed by the current generating source without requiring additional input from an operator or user of the current generating source. ### Claim 24 (depends on 23) The method of claim 23, wherein executing the first function comprises determining whether the effective resistance between the first and second electrodes is greater than a resistance threshold. ### Claim 25 (depends on 24) The method of claim 24, wherein the resistance threshold is at least 200 kilo-ohms. ### Claim 26 (depends on 23) The method of claim 23, wherein the first function is performed before the second function. ### Claim 27 (depends on 26) The method of claim 26, wherein executing the second function comprises providing an alert of an open circuit to a user or operator of the current generating source. ### Claim 28 (depends on 23) The method of claim 23, wherein executing the second function comprises reconfiguring the current generating source to provide a second electric current in the first direction. ### Claim 29 (depends on 28) The method of claim 28, wherein the second electric current is smaller than the first electric current. ### Claim 30 (depends on 28) The method of claim 28, wherein the first magnitude is greater than the voltage threshold when the second function is executed. ### Claim 31 An electrotherapy system, comprising: a first electrode and a second electrode, the first and second electrode each being configured to be connected to a biological recipient; and a current generating source connected to each of the first and second electrodes; wherein the current generating source is configured to provide a first electric current in a first direction through the biological recipient; the current generating source comprises means for sensing a first voltage difference between the first electrode and the second electrode to determine a first magnitude of the first voltage difference, means for comparing the first magnitude to a voltage threshold, and means for executing a first function; and the current generating source is operable to perform the sensing, the comparing, and the executing without additional input from an operator or user of the current generating source. ### Claim 32 A method of performing electrotherapy treatments on a patient, the method comprising: connecting a current generating source to the patient; configuring the current generating source to provide a first electric current at a first current level setpoint through the patient, the first current level setpoint being between 500 microamps and 5 milliamps; configuring the current generating source to provide a second electric current at a second current level setpoint through the patient, the second current level setpoint being between 10 nanoamps and 1 microamp; passing the first current through the patient for a first time period, wherein the first current has a first mean current value over the entire span of the first time period; and passing the second current through the patient for a second time period, wherein the second current has a second mean current value over the entire span of the second time period; wherein the first current deviates from the first mean current value by less than 10% of the first mean current value throughout the entire first time period; and the second current deviates from the second mean current value by less than 1% of the second mean current value throughout the entire second time period. ### Claim 33 A method of performing diagnostic measurements on a patient undergoing electrotherapy, the method comprising: providing a first electrode and a second electrode, the first and second electrodes each contacting the patient, wherein a portion of the patient's body is between the electrodes; providing a current generating source connected to each of the first and second electrodes, the current generating source being configured to provide a current through the patient; passing a first current through the patient for a first time period, the first current being below 200 microamps; raising the current to a second level for a second time period, the second current level being greater than 200 microamps; reducing the current back to the first current for a third time period; and measuring an impedance during the second time period; wherein the second time period is sufficiently small to prevent substantial changes in the impedance of the portion of the patient's body which is between the electrodes. ### Claim 34 (depends on 33) The method of claim 33, wherein the second time period is about 10 milliseconds or less.