External Dorsal Genital Nerve Stimulation for Incontinence

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Solution Overview

Problem

Current medical therapies for pelvic floor disorders such as urinary and fecal incontinence often require invasive methods or continuous stimulation, which may not be effective for all patients, and there is a need for a non-invasive, responsive solution to manage these conditions.

Innovation Solution

An external device that delivers electrical and mechanical stimulation to the dorsal genital nerve (DGN) using electrodes positioned on the skin, with sensing capabilities to detect urine leakage and adjust stimulation accordingly, providing intermittent or continuous therapy based on patient needs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If invasive methods or continuous stimulation are used for pelvic floor disorders, then therapy effectiveness may be improved, but patient comfort and treatment accessibility deteriorate

Engineering Contradiction:
Improvetherapy effectivenessVSAvoidinvasiveness and patient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses the dorsal genital nerve as an intermediary structure to deliver therapeutic effects to pelvic floor muscles without direct invasion. Electrical stimulation is applied externally through electrodes placed on the perineal skin, which then travels through the dorsal genital nerve to stimulate the pelvic floor muscles, achieving therapeutic effectiveness while avoiding invasive procedures

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces mechanical invasive stimulation methods with electrical stimulation delivered through external electrodes. Instead of physically inserting devices into the body, the system uses electrical fields generated by surface electrodes to stimulate nerves and muscles, eliminating the need for surgical intervention while maintaining therapeutic efficacy

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If continuous stimulation is provided, then symptom relief may be maintained, but energy consumption and device complexity increase

Engineering Contradiction:
Improvesymptom relief consistencyVSAvoidenergy consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The patent implements periodic stimulation delivery based on detected incontinence events rather than continuous stimulation. The system monitors for urine leakage events and delivers electrical stimulation pulses in response to these periodic occurrences, maintaining symptom relief consistency while significantly reducing overall energy consumption compared to continuous stimulation protocols

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The system incorporates sensors that detect urine leakage events and provide feedback to the stimulation controller. This feedback mechanism allows the device to adjust stimulation timing and intensity based on actual patient needs, ensuring consistent symptom relief while optimizing energy usage by avoiding unnecessary stimulation during periods when it is not required

Inventive Principle:
Principle #23Feedback

3Object-affected harmful factors

If external electrodes are used for DGN stimulation, then invasiveness is reduced, but stimulation precision and targeting accuracy may deteriorate

Engineering Contradiction:
ImproveinvasivenessVSAvoidstimulation targeting accuracy
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The patent places electrodes at specific localized positions on the perineal skin corresponding to the anatomical location of the dorsal genital nerve. The electrode arrangement and placement geometry are optimized to concentrate electrical current density at the target nerve location, achieving precise neural stimulation while maintaining external non-invasive application

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The system adjusts electrical stimulation parameters such as voltage, current density, pulse duration, and frequency to optimize targeting accuracy of the dorsal genital nerve. By modifying these electrical parameters, the system achieves precise nerve stimulation with external electrodes, compensating for the reduced spatial precision compared to invasive methods

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 effectively alleviates symptoms of urinary and fecal incontinence by stimulating the DGN externally, offering a non-invasive, responsive treatment that can be tailored to individual patient needs, improving bladder control and reducing incontinence episodes.

Implementation Method 1

an external device for stimulation of a dorsal genital nerve. The external device comprises a stimulation generator configured to generate stimulation for stimulation of a first dorsal genital nerve and a second dorsal genital nerve

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Implementation Method 2

at least two sensing electrodes and sensing circuitry configured to sense urine leakage via the sensing electrodes

Methodology Applied
Scientific EffectElectrical impedance sensing: Electrical Impedance Tomography

Data Source

PatentUS11925801B2External stimulation therapy for dorsal genital nerve stimulation
Publication Date: 2024.03.12 MEDTRONIC INC
  • US11925801B2 patent drawing
  • US11925801B2 patent drawing
  • US11925801B2 patent drawing

AI summary

A system including a stimulation generator configured to delivery external stimulation to control or alleviate urinary or fecal incontinence. The system may also include sense electrodes configured to sense the presence of wetness. The system may provide closed loop therapy based on the presence of wetness.