Pudendal Nerve Stimulator With Dual-Mode Sphincter Control

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Solution Overview

Problem

Individuals with neurological conditions such as spinal cord injuries face severe urinary and fecal incontinence or retention due to sphincter dyssynergia, with current treatments being invasive, risky, or ineffective, leading to significant medical complications and costs.

Innovation Solution

A device and method using a single electrode to stimulate the pudendal nerve with low-frequency stimulation to contract sphincters during storage and high-frequency stimulation to block involuntary contractions, allowing individuals to voluntarily control voiding and reduce the need for catheterization or manual extraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current treatments (catheterization, manual extraction) are used to manage urinary and fecal incontinence, then continence control is achieved, but invasive procedures and medical complications increase

Engineering Contradiction:
Improvecontinence controlVSAvoidinvasive procedures and medical complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces mechanical catheterization and manual extraction with electrical stimulation of the pudendal nerve. The stimulator device delivers electrical pulses to activate sphincter muscles, substituting mechanical intervention with neurostimulation to achieve continence control without invasive procedures

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

Solution Approach 2:

The patent enables the body's own nervous system to control continence through electrical stimulation of the pudendal nerve. The stimulated nerve pathways activate the body's inherent sphincter mechanisms, allowing self-regulated continence control without external mechanical assistance

Inventive Principle:
Principle #25Self-service

2Ease of operation

If electrical stimulation is used to control sphincter function, then voluntary voiding control is improved, but device complexity increases

Engineering Contradiction:
Improvevoluntary voiding controlVSAvoidstimulator device
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent employs a single electrode that can deliver multiple stimulation patterns (low-frequency for sphincter contraction, high-frequency for sphincter relaxation) through one device. This multi-functional approach achieves both storage and voiding control without requiring separate devices for each function

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent controls sphincter function by changing electrical stimulation parameters: low-frequency stimulation (e.g., 1-10 Hz) activates sphincter contraction for storage, while high-frequency stimulation (e.g., 50-100 Hz) induces relaxation for voiding. Parameter modulation enables dual functionality from a single device

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

Provides effective control over urinary and fecal continence, reducing incontinence episodes and the need for invasive procedures, improving quality of life and reducing healthcare costs by enabling voluntary voiding and enhancing sphincter coordination.

Implementation Method 1

stimulation of the pudendal nerve efferently, and afferently, is accomplished via a single electrode to both contract the external urethral sphincter and external anal sphincter

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Implementation Method 2

via a switch, to provide signals for a 'voiding mode' to allow the bladder and colon to fully void by relaxing the external urethral and anal sphincters

Methodology Applied
Scientific EffectHigh-frequency electrical block: Electrical Impedance Tomography

Data Source

PatentEP3820563B1Stimulator device for use in controlling waste storage for a patient
Publication Date: 2025.10.01 DIGNIFY THERAPEUTICS LLC
  • EP3820563B1 patent drawingFigure 1
  • EP3820563B1 patent drawingFigure 2
  • EP3820563B1 patent drawingFigure 3

AI summary

A stimulator device for use in controlling waste storage for a patient. The stimulator device having a set of at least one electrode placed in proximity to a relevant portion of a pudendal nerve. The stimulator device having a pulse generator connected to the set of at least one electrode to provide stimulation input for use by the electrode to stimulate the pudendal nerve. The pulse generator adapted to provide a first type of stimulation to cause waste to be stored within the patient and to provide a second type of stimulation different from the first type of stimulation. The second type of stimulation allows waste to be voided from the patient by blocking nerve impulses that would produce sphincter dyssynergia. An input device to allow an end user to select to apply the first type of stimulation or the second type of stimulation. Variations are also disclosed.