Transcutaneous Nerve Stimulation System for Selective Activation

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Solution Overview

Problem

Current nerve stimulation technologies face challenges in selectively activating peripheral nerves, particularly the saphenous nerve, due to deep anatomical locations and limitations in providing multi-site stimulation, leading to reduced therapeutic efficacy and increased side effects. Existing systems are not configured to adjust stimulation parameters for multiple targets, promote compliance, or offer flexible treatment options for conditions like overactive bladder.

Innovation Solution

A transcutaneous tissue stimulation system with external electrical generators and needle or TENS electrodes that allow for simultaneous stimulation of multiple nerves, including the saphenous nerve, using programmable protocols to enhance therapeutic efficacy, improve patient compliance, and reduce treatment costs through external and/or implanted components.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If transcutaneous electrical nerve stimulation (TENS) is used to stimulate peripheral nerves, then a non-invasive approach is achieved, but selective nerve activation is difficult due to intervening tissue and distance

Engineering Contradiction:
Improvenon-invasive approachVSAvoidselective nerve activation
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The system divides the stimulation circuit into multiple independent channels, each capable of targeting specific nerves. The multi-channel architecture allows selective activation of different peripheral nerves simultaneously or independently, overcoming the non-selectivity problem of conventional TENS while maintaining transcutaneous non-invasive operation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system employs specialized electrode configurations and pulse parameters tailored to specific nerve locations and characteristics. By adjusting stimulation parameters locally for each nerve target (different amplitudes, frequencies, and pulse widths), the system achieves selective activation of specific nerves while maintaining the non-invasive TENS approach.

Inventive Principle:
Principle #3Local quality

2Measurement precision

If percutaneous stimulation is used to stimulate target nerves, then selective nerve activation is improved, but therapeutic efficacy is reduced due to activation of non-target tissue

Engineering Contradiction:
Improveselective nerve activationVSAvoidtherapeutic efficacy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The system segments the stimulation signal into multiple independent channels, each configured to target specific nerves. This allows the system to activate only the intended target nerves while leaving non-target tissues unstimulated, thereby maintaining therapeutic efficacy while achieving selective activation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system dynamically adjusts stimulation parameters (amplitude, frequency, pulse width, duty cycle) for each channel based on the specific nerve being targeted. By optimizing parameters for each nerve's anatomical location and electrical characteristics, the system achieves selective activation without activating non-target tissues, thus maintaining therapeutic efficacy.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If implanted neurostimulators are used, then selective nerve stimulation is achieved, but long-term viability is complicated by mechanical movement causing lead fracture and component migration

Engineering Contradiction:
Improveselective nerve stimulationVSAvoidlong-term viability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The system extracts the stimulation function from implanted devices and implements it through external TENS units with percutaneous electrodes. By removing the implanted component, the system eliminates the mechanical movement problems (lead fracture, component migration) that compromise long-term viability, while maintaining selective nerve stimulation capability through sophisticated external control.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The system introduces an intermediary layer of external control and signal processing between the power source and the nerve stimulation. The external TENS unit acts as an intermediary that can be repositioned or replaced without affecting the nerve stimulation function, thereby eliminating the long-term reliability issues associated with implanted devices while maintaining selective stimulation capability.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If existing neurostimulation systems are used, then nerve stimulation is provided, but patient compliance is reduced due to complex treatment protocols and lack of flexibility

Engineering Contradiction:
Improvetherapeutic effectVSAvoidpatient compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system incorporates dynamic adjustment capabilities that allow real-time modification of stimulation parameters based on patient response and preferences. The interface enables patients to adjust parameters within safe limits, making the treatment adaptable to individual needs and improving compliance. The system can dynamically modify protocols without requiring complex manual intervention.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system incorporates feedback mechanisms that monitor patient response to stimulation and automatically adjust parameters to optimize therapeutic effect. By providing real-time feedback on treatment effectiveness and enabling patients to see the relationship between their actions and outcomes, the system improves motivation and compliance while maintaining reliable therapeutic results.

Inventive Principle:
Principle #23Feedback

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 effective therapeutic nerve activation with lower stimulation amplitude and shorter pulse width, improving comfort and compliance, and providing flexible treatment options for conditions like overactive bladder, while avoiding activation of non-targeted tissue.

Implementation Method 1

A transcutaneous tissue stimulation system with external electrical generators and needle or TENS electrodes that allow for simultaneous stimulation of multiple nerves

Methodology Applied
Scientific EffectElectrical stimulation: Conduction (electrical)

Data Source

PatentUS11229788B1Systems for improving neurostimulation compliance using a patient interface module
Publication Date: 2022.01.25 EBT MEDICAL INC
  • US11229788B1 patent drawing
  • US11229788B1 patent drawing
  • US11229788B1 patent drawing

AI summary

Nerve stimulation systems and methods are disclosed for providing improved compliance of a patient to a pelvic disorder treatment regimen. A patient interface module is connected to a control module for providing compliance information related to compliance criteria for a set of scheduled events. 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 to the patient or user operating the nerve stimulation system.