Neuromodulation Device Dual-Phase Pulse Waveform for Pain Relief
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Solution Overview
Problem
Current pain relief methods, such as drug-based treatments and spinal cord stimulation, often come with side effects and surgical risks, and provide limited long-term pain relief, while transcutaneous electrical nerve stimulation (TENS) is not effective for all patients and lacks sustained pain relief.
Innovation Solution
A neuromodulation device generating pulses with a fast rise-time spike waveform followed by a longer-duration, lower amplitude primary phase, tuned to cellular time constants, to induce conformational changes in nerve fibers without causing depolarization, thereby providing sustained pain relief and treating other conditions like inflammation or wound healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If spinal cord stimulation (SCS) is used to treat pain, then pain relief effectiveness is improved, but surgical risks and device implantation risks worsen
Solution Approach 1:
The patent replaces the mechanical/invasive SCS system with a transcutaneous electrical stimulation system that uses specially designed pulse waveforms. Instead of implanting electrodes in the spinal cord, the invention applies electrical stimulation through the skin using a dual-phase pulse waveform (spike phase followed by primary phase) that can modulate nerve fiber function without surgical intervention, thereby eliminating surgical risks while maintaining pain relief effectiveness.
Solution Approach 2:
The patent changes the electrical stimulation parameters by using a dual-phase pulse waveform with specific characteristics: a spike phase with high amplitude and short duration followed by a primary phase with lower amplitude and longer duration. This parameter configuration allows the stimulation to induce conformational changes in nerve fiber components rather than simple depolarization, achieving effective pain relief through non-invasive transcutaneous application.
2Ease of operation
If transcutaneous electrical nerve stimulation (TENS) is used to treat pain, then ease of operation is improved, but pain relief effectiveness and long-term relief worsen
Solution Approach 1:
The patent improves upon conventional TENS by changing the electrical stimulation parameters to a dual-phase pulse waveform. The spike phase (high amplitude, short duration) followed by the primary phase (lower amplitude, longer duration) creates conformational changes in nerve fiber components that produce more effective and sustained pain relief compared to standard TENS waveforms, while maintaining the non-invasive ease of operation.
Solution Approach 2:
The patent introduces dynamic modulation through the dual-phase waveform structure where the spike phase rapidly changes amplitude to induce conformational changes, followed by the primary phase that maintains the effect. This dynamic parameter variation within each pulse cycle enhances the therapeutic effect and prevents habituation, allowing for longer-term effective treatment while keeping the device easy to operate.
3Reliability
If conventional nerve stimulation causing depolarization is used, then pain relief is achieved, but habituation occurs reducing long-term effectiveness
Solution Approach 1:
The patent changes the stimulation mechanism from simple depolarization to conformational change induction by using a dual-phase pulse waveform. The spike phase with its rapid rise time and high amplitude creates strong electric fields that induce conformational changes in cellular or cell membrane components of nerve fibers. This different mechanism of action prevents habituation and allows for longer-term effective treatment.
Solution Approach 2:
The patent employs periodic dual-phase pulse trains where each pulse consists of a spike phase followed by a primary phase. This periodic application of specially structured pulses maintains therapeutic effect over time by repeatedly inducing conformational changes without causing habituation, thereby extending the duration of effective treatment.
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 device offers effective, long-term pain relief without the risks associated with invasive procedures or drug side effects, and can be used to treat various types of pain, including chronic and acute pain, by maintaining conformational changes through the primary phase of the pulse waveform.
Implementation Method 1
The timing of the parts of the pulses is tuned to the time constants of certain cellular or cell membrane components, and induces conformational changes which result in modified function of those components of nerve fibers
Implementation Method 2
The waveform and its parameters also prevent habituation of the treatment stimulation by the patient thereby enabling longer-term application of treatments while maintaining effectiveness
Data Source
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AI summary
Neuromodulation devices and methods of their use are described in which a therapeutic device is configured to generate a treatment for treating pain such as the reduction of the symptoms of chronic and acute pain as well as for treating other conditions. The neuromodulation device generates an output electrical signal in the form of pulses with a fast rise-time spike waveform followed by a longer-duration, lower amplitude primary phase waveform. The output signal includes a broad range of frequency components, with time constants tuned so as to interact with specific cell membrane or cellular components. The output signal may be conducted to the patient via electrodes. The pulses are triggered at variable intervals which prevent habituation.