# US 2025/0082932 A1 · Ankle cuff for managing incontinence > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2025/0082932 A1 - Document ID: US20250082932A1 - Status: Published application - Kind: A1 - Application number: 18/951,827 - Filed: 2024-11-19 - Published: 2025-03-13 - Earliest claimed: 2018-07-06 - Inventors: Nicky Agahari - Web page: https://patentgrep.com/patent/US20250082932A1 ## CPC - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61N 1/0502: {Skin piercing electrodes} - A61N 1/36017: {with leads or electrodes penetrating the skin} - A61N 1/36031: {using physiological parameters for adjustment} - A61N 1/36034: {specified by the stimulation parameters} - A61M 37/0015: {by using microneedles} - 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 1/36021: {for treatment of pain} - 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) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract An ankle cuff for managing incontinence in a patient, comprising: a body; a first micro-needle electrode array located on an inner face of the body; a second micro-needle electrode array separately located from the first micro-needle electrode array; a pulse generator electrically coupled to the first and second micro-needle electrode arrays; in use, the body is configured to be worn around an ankle of the patient such that individual micro-needles of the first and second micro-needle electrode arrays insert into an epidermis of the patient; and a controller, wherein the controller controls the pulse generator to pulse the first and second micro-needle electrode arrays to electrically stimulate the posterior tibial nerve for managing incontinence in the patient. ## Claims ### Claim 1 A cuff for administering neurostimulation to a nerve in the lower leg of a patient, the cuff comprising: an adhesive layer having an upper surface and a lower surface, wherein the lower surface attaches to the lower leg of the patient, a micro-needle electrode array on the lower surface of the adhesive layer, comprising a plurality of individual needles for applying an electrical stimulus to a posterior tibial nerve in the leg of the patient; wherein the adhesive layer has at least one aperture sized and shaped to receive a medial or lateral malleolus of the patient's ankle to locate the micro-needle electrode array superior to the posterior tibial nerve; an electrical pulse generator on the lower surface of the adhesive layer electrically coupled to the micro-needle electrode array; and a controller for operating the electrical pulse generator to stimulate the posterior tibial nerve. ### Claim 2 (depends on 1) The cuff of claim 1, further comprising a second electrode electrically connected to the controller and located between the medial malleolus and an Achilles tendon of the patient. ### Claim 3 (depends on 1) The cuff of claim 1, wherein the controller can program the plurality of individual needles of the micro-needle electrode array to pulse at different wavelengths, amplitudes or frequencies determined by the controller. ### Claim 4 (depends on 1) The cuff of claim 1, wherein the controller can program the plurality of individual needles of the micro-needle electrode array to be grouped into two or more electrode zones that are adapted to pulse at different wavelength, amplitudes or frequencies determined by the controller. ### Claim 5 (depends on 1) The cuff of claim 1, wherein the micro-needle electrode array is selected from the group consisting of hydrogel electrodes, silver electrodes, platinum electrodes and metal electrodes. ### Claim 6 (depends on 1) The cuff of claim 1, wherein a pulse generated by the electrical pulse generator is of sufficient amplitude, wavelength and frequency to at least reduce a symptom selected from the group consisting of urgent urination, urinary retention, urinary incontinence, frequent urination, mixed urinary incontinence, nocturia, interstitial cystitis, bladder discomfort, pelvic pain, faecal incontinence, constipation, irritable bowel syndrome, nocturnal enuresis, erectile dysfunction and persistent pelvic pain. ### Claim 7 (depends on 1) The cuff of claim 1, further comprising an accelerometer and wherein, in use, the controller is configured to collect acceleration data output by the accelerometer to determine when the patient is moving based on the collected accelerometer data and wherein when the patient is moving, the controller is configured to control the pulse generator to pulse the electrodes at a lower amplitude than when the patient is stationary. ### Claim 8 (depends on 1) The cuff according to claim 1, wherein the controller is configured to select at least one parameter of stimulation from the group consisting of time, wavelength, amplitude, and frequency to electrically stimulate the posterior tibial nerve. ### Claim 9 (depends on 7) The cuff of claim 7, wherein the controller is configured to evaluate acceleration data captured during a sleep time of the patient to determine occurrence of nocturia events and wherein the nocturia events are evaluated over time to predict future nocturia events for the patient. ### Claim 10 (depends on 9) The cuff of claim 9, wherein the controller is configured to control the pulse generator to pulse at a higher amplitude for a predetermined period before the predicted future nocturia events. ### Claim 11 (depends on 1) The cuff of claim 1, further comprising a gyroscope that is configured to output positional data of the patient and wherein the controller evaluates the positional data to determine whether the patient is standing, sitting or lying down and wherein the controller controls at least one of an amplitude, wavelength and frequency of the pulse based on the positional data.