# US 11,110,269 B2 · Electrostimulation related devices and methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,110,269 B2 - Document ID: US11110269B2 - Status: Granted - Kind: B2 - Application number: 15/500,896 - Filed: 2015-08-19 - Published: 2017-08-03 - Granted: 2021-09-07 - Earliest claimed: 2014-08-19 - Assignees: Femeda Ltd - Applicants: Femeda Ltd. - Inventors: Ian Gregson - Web page: https://patentgrep.com/patent/US11110269B2 ## CPC - A61N 1/0524: {Vaginal electrodes} - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61N 1/36125: {Details of circuitry or electric components} - A61N 1/36146: {specified by the stimulation parameters} - A61N 1/36153: {Voltage (A61N1/3616 takes precedence)} - A61N 1/37211: {Means for communicating with stimulators} - 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 There is disclosed a device and method for delivering constant target current to a muscle for electro-stimulation of that muscle. One device is a completely self-contained device with no external means for the adjustment and control of the electro-stimulation delivered to the muscle during treatment. The microprocessor based device monitors indirectly the actual current delivered to the muscle during electro-stimulation via measurement of the return path voltage through the muscle and optionally in addition monitors and adjusts for the internal battery voltage during use of the device in order to deliver a more consistent an accurate and effective target output current to the muscle being stimulated at each and every pulse delivered from the device. The device is pre-programmed with an electro-stimulation treatment cycle and the whole treatment cycle, including the monitoring and adjustment required to achieve this treatment cycle, is automatic within the device. ## Claims ### Claim 1 An electro stimulation device for delivering a target pulsed output current to muscle in contact with the device, which device comprises: a) a device body capable of being completely insertable into and removable from a vagina or anus, b) at least two electrodes for delivery of pulsed electro-stimulation current to muscle, c) at least one source of power, d) at least one control unit configured to: generate a required output voltage to achieve a target output current, measure return path voltage through the muscle from an initial decay period of an electro-stimulation pulse of a duration in the range of 100 to 350 μs at a single point between 20 to 40 μs after the start of the electro-stimulation pulse, and adjust the output voltage required to achieve a target output current for subsequent electro-stimulation based on the point measurement of the return path voltage. ### Claim 2 (depends on 1) A device according to claim 1, wherein the device is a self-contained device. ### Claim 3 (depends on 1) A device according to claim 1, further comprising a resistor for measuring the return path voltage through the muscle. ### Claim 4 (depends on 3) A device according to claim 3, wherein the resistor for measuring return path voltage has a resistance of from 10 to 100 ohms. ### Claim 5 (depends on 1) A device according to claim 1, wherein the power source is a battery. ### Claim 6 (depends on 1) A device as claimed in claim 1, further comprising a PCB with a microprocessor control unit internally within the device. ### Claim 7 (depends on 1) A device as claimed in claim 1 wherein the device further comprises isolation of the battery power source from the PCB and wherein the isolation is removable prior to use of the device. ### Claim 8 (depends on 7) A device as claimed in claim 7 wherein the isolation is a removable tab exposed to the exterior of the device and located internally between the internal battery and the internal PCB. ### Claim 9 (depends on 1) A device according to claim 1 further comprising a voltage limit. ### Claim 10 (depends on 9) A device according to claim 9 wherein the voltage limit comprises a Zener diode. ### Claim 11 (depends on 1) A device as claimed in claim 1 wherein the control unit is further configured for adjusting the output voltage of the device and/or any other voltage readings relative to the battery power level. ### Claim 12 (depends on 1) A device as claimed in claim 1 further comprising a reference voltage for battery power level determination. ### Claim 13 (depends on 12) A device as claimed in claim 12 wherein the reference voltage is provided via a fixed voltage reference point within the control unit circuit. ### Claim 14 (depends on 13) A device as claimed in claim 13 wherein the fixed voltage reference point is a diode of fixed voltage. ### Claim 15 (depends on 1) A device as claimed in claim 1, wherein the device is for delivering a target output current to the muscles of the pelvic floor either for treatment or exercise of the pelvic floor. ### Claim 16 (depends on 1) A device as claimed in claim 1 which further comprises data storage for storing the operating conditions, measured values and determined values used or determined during operation of the device. ### Claim 17 (depends on 16) A device as claimed in claim 16, which is adapted for access to the storage to read stored data during operation of the device. ### Claim 18 (depends on 16) A device as claimed in claim 16, which is adapted for access to the storage to read stored data after operation of the device is terminated or completed. ### Claim 19 (depends on 18) A device as claimed in claim 18, wherein the adaptation enables connection of the device via its electro conductive elements to a computer in order to read and/or copy data stored in the device to a computer for processing and/or storage on the computer. ### Claim 20 (depends on 1) A device as claimed in claim 1 further configured to generate an initial constant voltage phase during electro-stimulation. ### Claim 21 (depends on 1) A device as claimed in claim 1 further configured to generate a current ramp mode during electro-stimulation. ### Claim 22 (depends on 1) A device as claimed in claim 1 further configured to detect contact of the device with pelvic floor muscle. ### Claim 23 (depends on 1) A device as claimed in claim 1 wherein the at least one control unit is programmed to discharge any residual internal battery power on completion or interruption of the electrostimulation treatment cycle. ### Claim 24 (depends on 22) A device as claimed in claim 22, wherein the at least one control unit is configured to detect contact of the device with the pelvic floor muscle and to measure return path voltage through the muscle. ### Claim 25 A method of delivering a target pulsed output current for electro-stimulation of a muscle, comprising: providing an initial output voltage for delivery of the target output current for electro-stimulation; measuring a return path voltage from the electro-stimulated muscle; and where a return path voltage level indicates that the initial output voltage differs from that required for delivery of the target pulsed output current, adjusting the output voltage, wherein the step of measuring the return path voltage comprises measuring a voltage level from an initial decay period of a returned electro-stimulation pulse of a duration within the range of 100 to 350 μs at a single point between 20 to 40 μs after the start of the electro-stimulation pulse. ### Claim 26 (depends on 25) A method according to claim 25, comprising comparing the return path voltage to a target return path voltage related to the output voltage required for delivery of the target output current. ### Claim 27 (depends on 26) A method according to claim 26, wherein a target value for the target return path voltage is a root mean square voltage. ### Claim 28 (depends on 26) A method according to claim 26, wherein the target output current is a root mean square current. ### Claim 29 (depends on 25) A method according to claim 25, wherein the specified period is between 25 to 35 μs after the start of the returned electro-stimulation pulse. ### Claim 30 (depends on 25) A method according to claim 25, wherein the specified period is between 27.5 to 32.5 μs after the start of the returned electro-stimulation pulse. ### Claim 31 (depends on 25) A method according to claim 25, wherein the specified period is 30 μs after the start of the returned electro-stimulation pulse. ### Claim 32 (depends on 25) A method according to claim 25, wherein the return path voltage is determined as a root mean square voltage of the pulse. ### Claim 33 (depends on 25) A method according to claim 25, wherein the step of adjusting the output voltage comprises sequentially adjusting the voltage for successive measurements of return path voltage, wherein the sequence of adjustments falls within a given range of voltages. ### Claim 34 (depends on 25) A method according to claim 25, wherein the step of adjusting the output voltage comprises using pulse width modulation to vary the output voltage. ### Claim 35 (depends on 25) A media device storing computer program code adapted, when loaded into or run on a computer or processor, to cause the computer or processor to carry out a method according to claim 25.