Prescribed Nerve Stimulation Adjustment Through Protocol Comparison
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Solution Overview
Problem
Existing nerve stimulation systems face challenges in achieving selective nerve activation, particularly for deep nerves like the posterior tibial nerve, due to issues such as migration of implanted devices, non-localized magnetic fields, and the need for multiple stimulation sites, leading to reduced therapeutic effects and increased side effects.
Innovation Solution
A transcutaneous tissue stimulation system with external generators and multiple stimulation protocols for the saphenous and posterior tibial nerves, using needle electrodes and TENS electrodes, allowing for adjustable stimulation parameters and home-based therapy, with integrated compliance monitoring and gamification features.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transcutaneous electrical nerve stimulation (TENS) is used for non-invasive nerve stimulation, then patient comfort and ease of operation are improved, but selective nerve activation is reduced due to intervening tissue and distance from the nerve target
Solution Approach 1:
The system divides the stimulation approach into two parts: an external TENS device for comfortable transcutaneous stimulation and an implantable electrode for precise nerve targeting. This segmentation allows each component to excel at its specific function while working together to resolve the contradiction between comfort and selectivity.
Solution Approach 2:
The patent introduces an implantable electrode as an intermediary element that bridges the gap between the external TENS device and the target nerve. This intermediary enables the comfortable non-invasive external device to achieve precise selective nerve activation through the implanted electrode that is positioned directly on or near the nerve.
2Manufacturing precision
If percutaneous stimulation is used to achieve selective nerve activation, then therapeutic precision is improved, but invasiveness and device complexity increase
Solution Approach 1:
The implantable electrode is designed to be self-powered or passively charged by radio frequency pulses from the external device. This self-service capability eliminates the need for complex wired connections and reduces the overall system complexity while maintaining selective nerve activation precision.
Solution Approach 2:
The patent replaces the mechanical connection (wired connection between external device and electrode) with wireless radio frequency energy transmission. This substitution reduces device complexity and invasiveness while maintaining the ability to deliver precise selective nerve stimulation.
3Duration of action of stationary object
If implanted neurostimulators are used for long-term therapy, then therapeutic durability is improved, but mechanical movement causes lead fracture and component migration
Solution Approach 1:
The patent replaces the mechanical wired connection system with a wireless electromagnetic energy transmission system. The implantable electrode is powered or charged wirelessly through the body tissue, eliminating mechanical leads that are susceptible to fracture and migration from repeated body movements, thereby improving reliability while maintaining long-term therapeutic durability.
4Ease of operation
If BION wireless implantable electrode is used for selective nerve stimulation, then invasiveness is reduced, but device migration causes reduced therapeutic effects and increased side effects
Solution Approach 1:
The patent extracts the power source and control electronics from the implantable electrode, leaving only a simple passive electrode in the body. The external device provides all the complex functions including power transmission via radio frequency pulses. This extraction eliminates the mass that causes migration while maintaining wireless operation and selective nerve stimulation capability.
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
Enhances therapeutic efficacy, improves patient comfort and compliance, reduces treatment costs, and provides flexible, effective nerve stimulation for conditions like overactive bladder without frequent clinic visits.
Implementation Method 1
A transcutaneous tissue stimulation system with external generators and multiple stimulation protocols for the saphenous and posterior tibial nerves, using needle electrodes and TENS electrodes
Implementation Method 2
StimGuard has developed injectable implantable neurostimulators, which use wireless power in the RF and/or microwave frequency rage and non-inductive antennas which receive electromagnetic energy radiated from a source located outside of the patient's body
Data Source
AI summary
A neurostimulation system that has a programmer which has a power supply and processors with processing circuitry and a neurostimulation device which has power supply, processors and communication circuitry for providing communication with a neurostimulation device as well as communication circuitry for communication with the programmer. The neurostimulation system is configured to deliver treatment to a patient in accordance with a clinician prescribed protocol of a regimen. The neurostimulation system compares a delivered therapy treatment which has a treatment protocol to a defined treatment protocol of a prescribed treatment and adjusts the prescribed treatment stimulation parameters to compensate for a difference between the delivered neurostimulation therapy treatment and the prescribed treatment protocol for closely approximating the prescribed treatment protocol.