Foot Electrical Nerve Stimulation for Overactive Bladder Treatment
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Solution Overview
Problem
Current treatments for overactive bladder (OAB) and nocturnal enuresis, such as anti-muscarinics and sacral neuromodulation, have low efficacy and significant adverse effects, while existing non-invasive neuromodulation approaches are cumbersome and uncomfortable, lacking a safe and effective solution for urological and gastrointestinal disorders.
Innovation Solution
A non-invasive electrical nerve stimulation system using electrodes placed on the dorsal or plantar surface of the foot to stimulate specific nerves, providing pulses that inhibit bladder contractions and modulate urological and gastrointestinal activity, potentially combined with pharmacological substances like duloxetine or tolterodine.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If anti-muscarinics are used for OAB treatment, then bladder overactivity is reduced, but adverse effects increase and patient compliance decreases
Solution Approach 1:
The patent replaces pharmacological treatment (chemical system) with electrical nerve stimulation (physical system). The foot stimulation device uses electrical currents to activate the tibial nerve, which modulates bladder activity through neural pathways, substituting drug-based therapy with a physical stimulation approach that avoids medication-related adverse effects while maintaining treatment efficacy for overactive bladder
Solution Approach 2:
The patent introduces an intermediary neural pathway (tibial nerve) that connects the stimulation site (foot) to the target organ (bladder). By stimulating the tibial nerve in the foot, the electrical signals travel through the spinal cord to modulate sacral outflow to the bladder, providing an indirect but effective route to control bladder overactivity without direct contact with the bladder or use of chemicals
2Reliability
If sacral neuromodulation is implemented, then OAB symptoms are improved, but invasiveness and surgical requirements increase
Solution Approach 1:
The patent inverts the traditional neuromodulation approach by stimulating the foot instead of the sacral region. Conventional sacral neuromodulation places electrodes near the sacrum (close to the bladder), while this patent places electrodes on the foot (distant from the bladder) and uses the tibial nerve as a conduit to achieve bladder modulation, thereby avoiding invasive surgery while maintaining therapeutic effect
Solution Approach 2:
The patent separates the stimulation site from the target organ. Instead of placing electrodes directly near the bladder or sacrum, it divides the treatment into two distinct locations: the stimulation site (foot, specifically the tibial nerve region) and the target organ (bladder), connected through neural pathways. This segmentation allows non-invasive treatment while achieving the desired physiological effect
3Ease of operation
If tibial neuromodulation is used, then minimally invasive treatment is achieved, but treatment frequency and duration requirements increase
Solution Approach 1:
The patent employs periodic electrical stimulation delivered in structured sessions (e.g., 30 minutes, 3 times per week for 12 weeks, then maintenance). This periodic action pattern provides sufficient therapeutic effect over time while allowing rest periods between sessions, balancing treatment efficacy with patient convenience and minimizing total time commitment compared to continuous or more frequent treatments
4Reliability
If bedwetting alarms are used for nocturnal enuresis, then treatment effectiveness is achieved, but patient stress and sleep disruption increase
Solution Approach 1:
The patent replaces the alarm-based mechanical/audible stimulation system with electrical nerve stimulation. Instead of using alarms that detect and alert to wetting events (which cause stress and sleep disruption), the foot stimulation device uses electrical currents to prevent bedwetting by modulating bladder and bowel control mechanisms proactively, eliminating the need for disruptive alarm signals while maintaining treatment effectiveness
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively reduces bladder contractions and urinary frequency, improves bladder capacity, and provides a comfortable, non-invasive treatment option for OAB and other urological conditions, with potential for reducing symptoms of bedwetting and gastrointestinal issues.
Implementation Method 1
A non-invasive electrical nerve stimulation system using electrodes placed on the dorsal or plantar surface of the foot to stimulate specific nerves, providing pulses that inhibit bladder contractions and modulate urological and gastrointestinal activity
Data Source
AI summary
Provided herein are devices, systems, and methods for treating urological and gastrointestinal disorders, including bedwetting, through stimulation of the dorsal or plantar surface of the foot, including the superficial peroneal nerve and branches thereof, such as the dorsal intermediate and medial cutaneous nerves, or the medial and/or and lateral plantar nerves. The device facilitates placement of electrodes on the foot. Also provided herein is a system including the device, a pulse generator, and a controller, and methods of manufacturing and using the same.