Peripheral Nerve Stimulation via Implanted Intermediary Electrodes
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Solution Overview
Problem
Current nerve stimulation technologies, such as transcutaneous electrical nerve stimulation (TENS) and percutaneous nerve stimulation, face challenges in selectively activating target nerves due to intervening tissue and distance, leading to reduced therapeutic effects and increased side effects, particularly in treating conditions like overactive bladder, where deep nerves like the posterior tibial nerve are difficult to modulate effectively.
Innovation Solution
A transcutaneous tissue stimulation system with external electrical generators and needle or TENS electrodes that allow for simultaneous stimulation of multiple target nerves, including the saphenous and posterior tibial nerves, using paired configurations of external and implanted stimulation elements to enhance therapeutic efficacy and patient compliance, while minimizing activation of non-target tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transcutaneous electrical nerve stimulation (TENS) is used to stimulate deep nerves, then non-invasive approach is achieved, but 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 transcutaneous stimulation source and the deep target nerve. This intermediary electrode is positioned close to the target nerve (within 1-5 mm) to enable selective activation while maintaining non-invasive transcutaneous power delivery. The implanted electrode acts as a mediator that overcomes the limiting factor of distance and intervening tissue.
Solution Approach 2:
The patent adds a spatial dimension by using a paired configuration of electrodes - one implanted near the target nerve and another on the skin surface. This creates a focused stimulation field in the three-dimensional space between the electrodes, enabling selective nerve activation that overcomes the two-dimensional limitation of surface TENS alone.
2Manufacturing precision
If percutaneous stimulation is used to achieve selective nerve activation, then therapeutic efficacy is improved, but invasiveness and mechanical movement issues increase
Solution Approach 1:
The implanted electrode serves as a stable intermediary that remains fixed near the target nerve, eliminating the need for repeated percutaneous needle insertions. This mediator provides consistent selective nerve activation without the mechanical movement and fracture risks associated with percutaneous leads.
Solution Approach 2:
The patent replaces the mechanical percutaneous needle electrode system with a minimally implanted electrode that is positioned once and remains stable. This substitution eliminates the mechanical issues of repeated insertions, lead movement, and fracture while maintaining selective nerve activation capability.
3Reliability
If higher stimulation amplitude and longer pulse width are used to activate deep nerves, then nerve activation is achieved, but patient comfort and compliance decrease
Solution Approach 1:
The implanted electrode enables localized stimulation with high current density precisely at the target nerve site, while the surrounding tissue and skin surface experience lower current densities. This local quality differentiation allows effective deep nerve activation at lower overall amplitudes, improving patient comfort and compliance.
Solution Approach 2:
The implanted electrode as an intermediary concentrates the stimulation energy directly at the target nerve, reducing the need for high amplitude settings. This mediator enables reliable nerve activation at lower amplitudes and shorter pulse widths, thereby improving patient comfort while maintaining therapeutic efficacy.
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 provides effective therapeutic nerve activation with lower stimulation amplitude and shorter pulse width, improving comfort and compliance, and enabling home-based therapy for overactive bladder and other disorders without the need for frequent clinic visits.
Implementation Method 1
A neurostimulator for transcutaneous and/or percutaneous electrical stimulation of a target tissue in a patient
Implementation Method 2
an implanted passive element configured to modify electrical field signals generated by an external generator and provided by the stimulator
Data Source
AI summary
A neurostimulation system is disclosed for providing treatment to a patient during a therapy session. The neurostimulation system includes a neurostimulator for transmitting magnetic or electrical signals based upon a treatment program. A programmer is connected to the neurostimulator to set a treatment session parameter value to calculate a therapy compliance value. A compliance module is connected to the neurostimulator and the programmer to calculate and store a therapy compliance value. A control module is connected to the compliance module, the programmer and the neurostimulator and determines whether the therapy compliance value is within a range of the treatment program. The neurostimulator transmits electrical or magnetic signals to the patient in a treatment session only if the therapy compliance value meets a compliance criteria.