Flexible Electrodes for Tibial Nerve Stimulation
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Solution Overview
Problem
Current treatments for polyneuropathy, such as percutaneous tibial nerve stimulation, often require invasive procedures and continuous clinical oversight, and may not effectively address chronic pain and incontinence issues in patients with diabetes-related polyneuropathy.
Innovation Solution
A method involving flexible electrodes placed within 1 mm of the tibial nerve, driven by an external control unit to deliver currents of specific amplitudes and frequencies, using a housing that maintains contact and can be coupled to the nerve via shape-changing materials or spiral coupling elements, allowing for non-invasive and responsive treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If percutaneous electrode insertion is used to stimulate the tibial nerve, then pelvic pain and incontinence can be treated, but the procedure becomes invasive and requires continuous clinical oversight
Solution Approach 1:
The patent replaces the mechanical percutaneous electrode insertion with a non-invasive capacitive coupling system. The wearable device uses electrodes that couple capacitively to the skin surface, eliminating the need for skin penetration and surgical implantation while maintaining neural stimulation functionality for treating pelvic pain and incontinence
Solution Approach 2:
The patent enables patients to self-administer the therapy through a wearable device that can be easily applied and removed by the patient themselves. The device includes a controller that allows patients to adjust stimulation parameters and operate the system without requiring continuous clinical oversight or professional intervention
2Reliability
If traditional neurostimulation devices are used, then chronic pain can be blocked, but the devices require implantation into the chest cavity or abdomen
Solution Approach 1:
The patent replaces the implanted generator and lead system with an external wearable device that uses capacitive coupling to deliver high-frequency stimulation. This substitution eliminates the need for chest cavity or abdominal implantation while maintaining the ability to block chronic pain signals through the tibial nerve
Solution Approach 2:
The patent extracts the stimulation generation function from an implanted device and relocates it to an external wearable unit. The capacitive coupling interface allows the external device to drive the tibial nerve without requiring any implanted components, thereby simplifying the overall system and eliminating surgical implantation
3Reliability
If percutaneous tibial nerve stimulation is performed, then urinary urgency and frequency can be treated, but the procedure requires electrode insertion into the ankle
Solution Approach 1:
The patent replaces the percutaneous electrode insertion procedure with a non-invasive capacitive coupling system. The wearable device places electrodes on the skin surface of the ankle region, creating a capacitive interface that allows neural stimulation without penetrating the skin, thereby treating urinary urgency and frequency without invasive procedures
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 method provides significant pain relief for patients with polyneuropathy, with effects lasting several hours to days, and is more effective than traditional anti-neuropathic pain medications, offering a non-invasive and patient-administered solution for chronic pain management.
Implementation Method 1
the electrodes are configured to be placed in contact with a portion of the subject's body within 1 mm of a tibial nerve of the subject
Data Source
AI summary
Apparatus and methods are described, including identifying a subject as suffering from polyneuropathy. In response to the identifying, electrodes are placed within 1 mm of a tibial nerve of the subject, the electrodes being disposed on a housing that is at least partially flexible. The electrodes are driven to treat the polyneuropathy by driving a current into the tibial nerve. Other embodiments are also described.