Direct Current Nerve Block Control for Lead Voltage Safety
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Solution Overview
Problem
Current spinal cord stimulation systems for pain management are imperfect as they do not completely inhibit pain transmission and can cause uncomfortable side effects like paresthesia, and existing nerve conduction technologies lack direct methods to block pain fibers.
Innovation Solution
A direct current electrode system that delivers direct current via electrodes to target tissues, measuring and adjusting voltage and impedance to maintain a nerve block, using a controller to adjust current magnitude based on peak voltage measurements, and employing a renewable electrode system to renew the electrode.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high amplitude electrical signals are delivered to achieve nerve conduction block, then the therapeutic effect is improved, but the risk of lead burnout and tissue damage increases
Solution Approach 1:
The control system continuously monitors the voltage drop across the lead and compares it to a predetermined threshold. When the voltage drop exceeds the threshold, indicating increasing impedance that could lead to burnout, the system automatically adjusts or terminates the electrical signal delivery, preventing tissue damage while maintaining effective nerve block when conditions are safe
Solution Approach 2:
The system dynamically changes the electrical signal parameters (amplitude, duration, frequency) based on real-time impedance measurements and voltage drop calculations. By adjusting these parameters within safe operating envelopes, the system maintains therapeutic efficacy while preventing conditions that would cause lead burnout or tissue damage
2Reliability
If direct current is delivered via electrode lead to target tissue, then nerve conduction block is achieved, but voltage drop across the lead can cause safety issues
Solution Approach 1:
The control system measures the actual voltage drop across the lead during signal delivery and uses this feedback to adjust the delivered current in real-time, ensuring the voltage drop remains within safe limits while maintaining effective nerve block
Solution Approach 2:
The system transitions from static, fixed-parameter electrical delivery to dynamic, adaptive delivery where signal parameters are continuously adjusted based on real-time measurements of lead impedance and voltage drop, optimizing safety and efficacy
3Device complexity
If lead impedance is not monitored, then device complexity is reduced, but safety risks from undetected lead failures increase
Solution Approach 1:
The control system performs self-diagnosis by continuously measuring its own operating parameters (voltage drop, impedance) and automatically adjusting or terminating signal delivery when safety thresholds are exceeded, providing inherent safety monitoring without requiring external surveillance systems
Solution Approach 2:
The system incorporates real-time feedback loops that measure lead impedance and voltage drop, providing continuous monitoring of lead health status and enabling automatic safety responses without adding significant external complexity
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
Effectively blocks nerve conduction, reducing pain and side effects, with the renewable electrode system maintaining nerve suppression after current cessation, and providing prolonged nerve block without rapid recovery.
Implementation Method 1
measuring the body impedance; determining a voltage drop across the lead from the body impedance measurement
Data Source
Figure 1A~1B
Figure 1C
Figure 1D(i)~1D(iii)
AI summary
Disclosed herein are systems and methods for nerve conduction block that can involve the delivery of relatively high amounts of charge safely to tissue. Such systems and methods can include control systems for safely monitoring a direct current electrode system, including delivering direct current via an electrode lead to a target tissue of a patient; measuring the driving voltage across the electrode; comparing the driving voltage across the electrode to predetermined threshold range values; measuring the body impedance; determining a voltage drop across the lead from the body impedance measurement; and adjusting the driving voltage to maintain the voltage drop across the lead within a predetermined voltage range.