CPC A61N 1/36007 (2013.01) [A61N 1/0502 (2013.01); A61N 1/36017 (2013.01); A61N 1/36031 (2017.08); A61N 1/36034 (2017.08); A61M 37/0015 (2013.01); A61N 1/36021 (2013.01)] | 13 Claims |
1. An ankle cuff for managing incontinence in a patient comprising:
a body;
a first negative micro-needle electrode array located on an inner face of the body directly superior to the posterior tibial nerve and between the medial malleous and Achilles tendon of the patient; the body configured to have at least one aperture sized and shaped to receive the corresponding medial and/or lateral malleolus of the patient's ankle to position the first negative micro-needle electrode array superior to the posterior tibial nerve of the patient;
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; the body being configured to be worn around an ankle of the patient such that individual micro-needles 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;
an accelerometer wherein, in use, the controller is configured to collect acceleration data output by the accelerometer to determine when the patient is moving 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 if the patient were stationary;
wherein the acceleration data is evaluated by the controller to determine at least one of a time, wavelength, amplitude and frequency to electrically stimulate the posterior tibial nerve and manage incontinence in the patient;
wherein the controller is configured to evaluate acceleration data captured during a sleep time of the patient to determine potential nocturia events and wherein the potential nocturia events are evaluated over time to predict future nocturia events for the patient and wherein the controller activates the pulse generator prior to avert the potential nocturia events.
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