Transdermal Nerve Stimulation via Modulated Waveforms

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Solution Overview

Problem

Current devices for stimulating the pudendal nerve to treat incontinence are invasive, provide constant stimulation, and often result in unwanted effects on other areas of the body due to non-selective nerve activation.

Innovation Solution

A nerve stimulation device that uses a transdermal patch with a first waveform generator producing a low-frequency signal and a second waveform generator producing a high-frequency carrier signal, modulated to create a modulated waveform applied through an electrode, allowing selective and controlled stimulation of the pudendal nerve based on biofeedback data from implanted sensors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a needle is extended into the sacral nerve bundle to stimulate the sacral nerve, then nerve stimulation for treating incontinence is achieved, but the device becomes invasive and causes unwanted stimulation effects on other areas of the body

Engineering Contradiction:
Improvetreatment efficacyVSAvoidunwanted stimulation effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by using multiple independently controllable electrode contacts that can selectively stimulate specific nerve fibers. Each electrode contact can be activated independently or in combination, allowing targeted stimulation of the pudendal nerve while avoiding stimulation of adjacent nerve structures. This spatial selectivity enables localized nerve activation without the unwanted systemic effects associated with broader sacral nerve stimulation.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent segments the nerve stimulation into multiple independent electrode contacts arranged in a array configuration. This segmentation allows selective activation of specific nerve pathways by controlling individual electrodes or electrode combinations. The segmented approach enables precise targeting of the pudendal nerve while avoiding collateral stimulation of other sacral nerve roots, thereby reducing unwanted side effects.

Inventive Principle:
Principle #1Segmentation

2Duration of action of stationary object

If a constant signal is supplied to stimulate the pudendal nerve, then continuous nerve stimulation is achieved, but the device remains invasive and produces the same unwanted side effects

Engineering Contradiction:
Improvecontinuous stimulationVSAvoidunwanted stimulation effects
Core Design Contradiction:
Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent implements periodic action by delivering nerve stimulation in the form of programmable pulse trains with variable frequency, amplitude, and duty cycle parameters. Rather than continuous constant stimulation, the device delivers periodic electrical pulses that can be adjusted to achieve therapeutic effects while minimizing side effects. The periodic delivery allows for rest periods and flexible dosing regimens that reduce cumulative unwanted effects.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent applies dynamics by making the stimulation parameters programmable and adjustable. The electrode array can deliver varying pulse frequencies, amplitudes, and patterns that can be dynamically modified based on patient response and therapeutic needs. This dynamic control allows optimization of stimulation efficacy while minimizing unwanted effects through real-time parameter adjustment.

Inventive Principle:
Principle #15Dynamics

3Adaptability or versatility

If the sacral nerve as a whole is stimulated, then broad nerve activation is achieved, but multiple other areas of the body are innervated resulting in leg twitches and other unwanted effects

Engineering Contradiction:
Improvebroad nerve activationVSAvoidleg twitches
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by using multiple independently controllable electrode contacts that can selectively stimulate specific nerve fibers. Each electrode contact can be activated independently or in combination, allowing targeted stimulation of the pudendal nerve while avoiding stimulation of adjacent nerve structures. This spatial selectivity enables localized nerve activation without the unwanted systemic effects associated with broader sacral nerve stimulation.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent applies parameter changes by utilizing variations in electrical stimulation parameters (frequency, amplitude, pulse width) in combination with selective electrode activation. By changing the electrical parameters and which specific electrodes are activated, the device can target different nerve pathways within the sacral plexus. This enables selective pudendal nerve stimulation while avoiding activation of nerves that innervate the legs, thereby preventing leg twitches and other unwanted effects.

Inventive Principle:
Principle #35Parameter changes

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 provides targeted and controlled stimulation of the pudendal nerve, reducing unwanted side effects and improving treatment efficacy for incontinence by using biofeedback to adjust stimulation according to physiological conditions.

Implementation Method 1

a first waveform generator adapted to generate a first waveform having a frequency capable of stimulating a predetermined nerve of the mammal, a second waveform generator adapted to generate a carrier waveform having a frequency capable of passing through tissue of the mammal, a modulation device electrically coupled to the first and second waveform generators and adapted to modulate the first and carrier waveforms to create a modulated waveform

Methodology Applied
Scientific EffectWaveform modulation: Phase Modulation

Implementation Method 2

an electrode electrically coupled to the modulation device and positioned substantially adjacent to skin of the mammal, and adapted to apply the modulated waveform thereto

Methodology Applied
Scientific EffectElectrical conduction through tissue: Conduction (electrical)

Data Source

PatentEP2383015B1System for nerve stimulation
Publication Date: 2017.08.23 ETHICON INC
  • EP2383015B1 patent drawingFigure 1
  • EP2383015B1 patent drawingFigure 2
  • EP2383015B1 patent drawingFigure 3

AI summary

A system and method for stimulating a nerve, wherein the system includes a first waveform generator adapted to generate a first waveform having a frequency capable of stimulating a predetermined nerve of the mammal, a second waveform generator adapted to generate a carrier waveform having a frequency capable of passing through tissue of the mammal, a modulation device electrically coupled to the first and second waveform generators and adapted to modulate the first and carrier waveforms to create a modulated waveform, and an electrode electrically coupled to the modulation device and positioned substantially adjacent to skin of the mammal, and adapted to apply the modulated waveform thereto.