Transcutaneous Tibial Nerve Stimulation Wearable with Remote Monitoring
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Solution Overview
Problem
Current posterior tibial neuromodulation treatments for urinary incontinence, fecal incontinence, and pelvic pain face challenges in patient compliance due to invasive procedures, limited mobility, and the inability to monitor treatment effectiveness remotely, leading to high dropout rates and potential placebo/nocebo effects.
Innovation Solution
A transcutaneous posterior tibial nerve stimulation system comprising a wearable neuromodulation device, a mobile application, and a web service that enables remote monitoring and feedback, allowing patients to administer treatments independently while providing visual and auditory cues, and utilizing indoor positioning to optimize treatment protocols based on location and activity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transcutaneous electrical stimulation is delivered to the tibial nerve, then treatment effectiveness for pelvic floor disorders is improved, but patient compliance deteriorates due to difficulty in maintaining treatment plans
Solution Approach 1:
The system incorporates a mobile application that monitors and tracks treatment delivery, providing visual feedback to patients about their treatment compliance and effectiveness. The web service transmits treatment protocols and receives compliance data, creating a closed-loop feedback system that motivates patients to maintain their treatment plans while ensuring effective nerve stimulation is delivered
Solution Approach 2:
The wearable neuromodulation device is designed for patient self-administration at home without requiring clinical supervision. Patients can independently apply the device and follow treatment protocols guided by the mobile application, eliminating the need for frequent clinic visits and enabling them to maintain treatment plans autonomously
2Ease of operation
If remote monitoring capability is added to the neuromodulation system, then treatment compliance monitoring is improved, but device complexity increases
Solution Approach 1:
The monitoring system is segmented into separate functional components: the wearable neuromodulation device handles stimulation delivery, the mobile application handles local data processing and user interaction, and the web service handles remote data storage and protocol management. This segmentation distributes complexity across multiple independent systems rather than concentrating it all in the wearable device
Solution Approach 2:
The mobile application serves as an intermediary between the simple wearable neuromodulation device and the comprehensive web service. It collects data from the device, provides user interface functionality, and communicates with the web service, thereby shielding the wearable device from the complexity of remote monitoring infrastructure while still enabling full monitoring capabilities
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 improves patient compliance and treatment effectiveness by enabling remote, non-invasive administration of neuromodulation, providing accurate monitoring and feedback, and reducing dropout rates through personalized treatment protocols, thereby enhancing the efficacy of treatments for urinary incontinence, fecal incontinence, and pelvic pain.
Implementation Method 1
the neuromodulation device configured for transcutaneous delivery of electrical stimulation to the tibial nerve
Implementation Method 2
the neuromodulation device further includes at least one light-emitting diode (LED) configured to emit light responsive to the transcutaneous delivery of the electrical stimulation to the tibial nerve
Implementation Method 3
the neuromodulation device further includes an buzzer configured to generate audio signals responsive to the transcutaneous delivery of the electrical stimulation to the tibial nerve
Data Source
AI summary
A system for nerve stimulation can include a neuromodulation device configured to be worn by a patient, the neuromodulation device configured for transcutaneous delivery of electrical stimulation to the tibial nerve; a mobile application executing on a mobile device in communication with the neuromodulation device, the mobile application configured to monitor the transcutaneous delivery of the electrical stimulation by the neuromodulation device and cause the mobile device to display information about the transcutaneous delivery of the electrical stimulation to the tibial nerve; and a web service in communication with the mobile application, the web service configured to transmit, to the mobile application, a treatment protocol and notifications defining the transcutaneous delivery of the electrical stimulation to the tibial nerve and receive, from the mobile application, the information about the transcutaneous delivery of the electrical stimulation to the tibial nerve.