Transcutaneous Nerve Stimulation with Implanted Electrode
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Solution Overview
Problem
Current nerve stimulation technologies face challenges in selectively activating target nerves due to intervening tissue and depth, leading to reduced therapeutic effects and increased side effects, particularly in treating overactive bladder, where deep nerves like the posterior tibial nerve are difficult to modulate effectively with existing transcutaneous electrical nerve stimulation (TENS) systems.
Innovation Solution
A transcutaneous tissue stimulation system that includes external electrical generators coupled with needle or TENS electrodes, allowing for stimulation of multiple target nerves with different protocols, including the saphenous nerve, to provide effective therapeutic activation with lower stimulation amplitude and shorter pulse width, and incorporates features for home-based therapy, compliance monitoring, and gamification to enhance treatment adherence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transcutaneous electrical nerve stimulation (TENS) is used to stimulate deep nerves like the posterior tibial nerve, then the stimulation can be non-invasive and simple, but the selective nerve activation is reduced due to intervening tissue and distance
Solution Approach 1:
The patent introduces an implanted electrode as an intermediary element between the TENS device and the target nerve. This electrode is positioned close to the deep nerve (saphenous or posterior tibial nerve) through minimally invasive percutaneous injection, serving as a mediator that enables selective activation while maintaining the non-invasive nature of the TENS controller and power supply.
Solution Approach 2:
The patent transitions from purely transcutaneous surface stimulation to a hybrid approach by adding a third dimension - an implanted electrode positioned at depth near the target nerve. This spatial dimensionality change allows the stimulation to bypass intervening tissue limitations and achieve precise nerve activation while keeping the external interface simple.
2Measurement precision
If percutaneous needle electrodes are used to stimulate deep nerves, then selective nerve activation is improved, but the procedure becomes more invasive and complex
Solution Approach 1:
The implanted electrode is designed to be self-positioned through percutaneous injection without requiring complex surgical procedures. The electrode autonomously achieves its therapeutic position near the target nerve through a simple injection process, and once implanted, it requires no further adjustment or intervention for positioning, thereby reducing procedural complexity while maintaining precise nerve activation.
3Reliability
If higher stimulation amplitude and longer pulse width are used to reach deep nerves, then nerve activation is achieved, but patient comfort is reduced and side effects increase
Solution Approach 1:
The implanted electrode enables localized stimulation precisely at the target nerve site (saphenous or posterior tibial nerve) with concentrated current delivery. This local quality approach allows effective nerve activation with lower overall stimulation amplitudes compared to transcutaneous methods, reducing patient discomfort and minimizing activation of non-target tissues, thereby decreasing side effects while maintaining reliable therapeutic effect.
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 enables more effective and comfortable nerve stimulation with improved patient compliance, reduced treatment costs, and increased therapeutic efficacy by allowing stimulation of previously hard-to-reach nerves like the saphenous nerve, potentially offering a first-line treatment option for overactive bladder without the need for frequent clinic visits.
Implementation Method 1
A transcutaneous tissue stimulation system includes one or more electrical generators external to a patient and one or more stimulators electrically coupled to the one or more electrical generators
Data Source
AI summary
Nerve stimulation systems and methods are disclosed for providing improved compliance of a patient to a therapy regimen. Patient compliance is assessed and notification or treatment events can be scheduled, rescheduled or otherwise adjusted based upon patient compliance or non-compliance according to compliance rules and parameters of a treatment compliance module. Both compliance and non-compliance may lead to adjustment of the treatment regimen, scheduled treatment events, and notifications. Gamification of the treatment regimen allows users to obtain points that may be used to receive virtual awards, status awards, or monetary compensation of various forms. Monitoring of usage and compliance can be managed both locally and remotely from the user. Stimulation treatment, compliance monitoring, and gamification is disclosed for treatments using external or implanted stimulators, or the combination.