# US 11,077,301 B2 · Topical nerve stimulator and sensor for bladder control > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,077,301 B2 - Document ID: US11077301B2 - Status: Granted - Kind: B2 - Application number: 15/048,760 - Filed: 2016-02-19 - Published: 2017-10-05 - Granted: 2021-08-03 - Earliest claimed: 2015-02-21 - Assignees: NeurostimOAB, Inc. - Applicants: Neurostim OAB, Inc. - Inventors: Graham Creasey; Hoo-Min D Toong - Web page: https://patentgrep.com/patent/US11077301B2 ## CPC - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61B 5/204: {Determining bladder volume} - A61B 5/205: {Determining bladder or urethral pressure} - A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)} - A61B 5/4887: {Locating particular structures in or on the body} - A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)} - A61B 8/08: Clinical applications (A61B8/02, A61B8/04, A61B8/06 take precedence) - A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)} - A61B 5/1073: {Measuring volume, e.g. of limbs} - A61B 5/1075: {for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer (A61B8/0858 takes precedence)} - A61B 5/4893: {Nerves} - A61B 2505/07: Home care - A61B 2505/09: Rehabilitation or training - A61B 2562/0247: Pressure sensors - 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 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)} - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract What is provided is a method and apparatus for modifying bladder function comprising: applying a dermal patch having an integral electrode in proximity to a sacral or pudendal nerve; selecting the sacral or pudendal nerve by a sensor integral on the dermal patch; determining a stimulation corresponding to the sacral or pudendal nerve, by logic of the dermal patch; applying the stimulation by the electrodes and a stimulator integral to the dermal patch to produce an electric field; and selectively activating the sacral or pudendal nerve by the electric field. ## Claims ### Claim 1 A method of modifying bladder function of a user comprising: applying a dermal patch on an external surface of a skin of the user on a lower leg of the user adjacent to a tibial nerve, the dermal patch comprising electrodes, a sensor, communications, a control unit and a stimulator, the electrodes, the sensor, the communications, the control unit and the stimulator integral to the dermal patch; automatically determining a state of a bladder of the user using the sensor; determining an electrical stimulation corresponding to the tibial nerve, by the control unit of the dermal patch, the control unit processing instructions comprising: in response to the automatically determined state of the bladder, automatically initiating an applying, without user intervention, on the external surface of the skin, of the electrical stimulation by the electrodes and the stimulator to produce an electric field; and selectively activating the tibial nerve by the electric field using the electrodes on the external surface of the skin to inhibit a contraction of the bladder. ### Claim 2 (depends on 1) The method of claim 1, further comprising applying the dermal patch in the proximity of a sacral or pudendal nerve. ### Claim 3 (depends on 1) The method of claim 1, the dermal patch comprising a system on a chip that includes the control unit, the electrodes and the stimulator and determining a subset of the electrodes that are active by the selectively activating, the subset of electrodes less than all of the electrodes that are integral to the dermal patch, the determining based on a determination of a type of nerve to be stimulated. ### Claim 4 (depends on 1) The method of claim 1, further comprising applying the dermal patch in the proximity of a branch or tributary of the tibial nerve. ### Claim 5 (depends on 1) The method of claim 1, the electric stimulation comprising square waves having an amplitude between 20 and 100 volts, pulse widths between 100 and 500 microseconds, and a pulse repetition rate of between 3 and 30 pulses per second. ### Claim 6 (depends on 1) The method of claim 1, the state of the bladder indicating an urge to urinate by the user and the automatically initiating the applying occurring before the user is aware of the urge. ### Claim 7 (depends on 1) The method of claim 1, further comprising sensing physiological feedback based upon the activation of the stimulator and activating the electrodes based at least in part on the feedback. ### Claim 8 (depends on 1) The method of claim 1, further comprising selecting from a plurality of pulse strengths or pulse types and applying the stimulation in accordance with the selected pulse strength or pulse type. ### Claim 9 (depends on 1) The method of claim 1, further comprising the electric field targeting a urethral sphincter for reflex or direct activation. ### Claim 10 (depends on 1) The method of claim 1, further comprising modifying stress incontinence, overactive bladder incontinence or urge incontinence. ### Claim 11 (depends on 1) The method of claim 1, the automatically determining the state of the bladder comprising detecting by an acoustic transceiver integral to the dermal patch an acoustic echo from a pelvic region indicating a position of a bladder, a shape of the bladder or a volume of the bladder; and automatically activating the electrodes, by the stimulator, to inhibit bladder contraction based at least in part on the acoustic echo. ### Claim 12 (depends on 1) The method of claim 1, further comprising modifying the stimulation based upon a manual input received at a wireless device wirelessly connected to the dermal patch or a sensor input. ### Claim 13 (depends on 1) The method of claim 1, the automatically determining the state of the bladder of the user comprising: sensing a physiological pattern of activity indicating an impending sneeze, cough or episode of straining. ### Claim 14 (depends on 1) The method of claim 1, further comprising: recording by the dermal patch an activation profile; assimilating a plurality of activation profiles for multiple dermal patches by wireless communication from the dermal patch to a remote controller; analyzing the activation profiles by the controller; communicating the activation profile analysis results by the controller wirelessly to the dermal patch; and modifying the stimulation based at least in part on the activation profile analysis results. ### Claim 15 A bladder control system for modifying bladder function of a user, the system comprising: a dermal patch configured to be applied on an external surface of a skin of the user on a lower leg of the user adjacent to a tibial nerve, comprising electrodes, a sensor, communications, a control unit and a stimulator, the electrodes, the sensor, the communications, the control unit and the stimulator integral to the dermal patch; the control unit processing instructions that, when executed, configure the control unit to: automatically determine a state of a bladder of the user using the sensor; determine an electrical stimulation corresponding to the tibial nerve; in response to the automatically determined state of the bladder, automatically initiate an applying, without user intervention, on the external surface of the skin, the electrical stimulation by the electrodes and the stimulator to produce an electric field; and selectively activating the tibial nerve by the electric field using the electrodes on the external surface of the skin to inhibit a contraction of the bladder. ### Claim 16 (depends on 15) The bladder control system of claim 15, the dermal patch comprising a system on a chip that includes the control unit, the electrodes and the stimulator, the control unit further configured to determining a subset of the electrodes that are active by the selectively activating, the subset of electrodes less than all of the electrodes that are integral to the dermal patch, the determining based on a determination of a type of nerve to be stimulated. ### Claim 17 (depends on 15) The bladder control system of claim 15, the control unit further configured to receive a manual command received from a wireless device to activate the stimulator. ### Claim 18 (depends on 15) The bladder control system of claim 15, the control unit further configured to sense physiological feedback based upon the activation of the stimulator and activating the electrodes based at least in part on the feedback. ### Claim 19 (depends on 15) The bladder control system of claim 15, the electric stimulation comprising square waves having an amplitude between 20 and 100 volts, pulse widths between 100 and 500 microseconds, and a pulse repetition rate of between 3 and 30 pulses per second. ### Claim 20 (depends on 15) The bladder control system of claim 15, the state of the bladder indicating an urge to urinate by the user and the automatically initiate the applying occurring before the user is aware of the urge.