Intravaginal Sensor Feedback for Incontinence Neuromodulation

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Solution Overview

Problem

Current methods for treating urinary and fecal incontinence, such as electrical stimulation therapy, face challenges in device positioning and identifying responsive individuals, particularly in women with pelvic floor disorders.

Innovation Solution

A system comprising an intravaginal device with sensors and an implantable lead for sacral nerve stimulation, combined with a medical device for electrical stimulation, allows for precise monitoring and optimization of treatment by detecting pelvic floor muscle movements and providing real-time feedback.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electrical stimulation therapy is used to treat urinary and fecal incontinence, then treatment can be provided to patients with pelvic floor disorders, but difficulties arise in positioning the neuromodulation devices and identifying women likely to be responsive to treatment

Engineering Contradiction:
Improvetreatment effectivenessVSAvoiddevice positioning
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent employs sensors (accelerometers, pressure sensors, EMG sensors) that provide real-time feedback on pelvic floor muscle movement and device positioning. This feedback loop allows the system to monitor whether the device is correctly positioned and whether the stimulation is producing the desired muscle response, thereby resolving the positioning difficulty while maintaining treatment effectiveness

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces manual positioning and assessment methods with automated sensor-based detection systems. Instead of relying on manual evaluation of device placement and muscle response, the system uses electronic sensors to objectively measure pelvic floor movement, thereby eliminating the complexity of manual positioning while ensuring reliable treatment delivery

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

2Reliability

If electrical stimulation therapy is used to treat urinary and fecal incontinence, then treatment can be provided to patients with pelvic floor disorders, but challenges arise in identifying women likely to be responsive to such treatment

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidpatient responsiveness
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The system uses sensors to provide real-time feedback on pelvic floor muscle response to stimulation. By measuring actual muscle movement and electrical activity, the system can objectively determine whether a patient is responding to treatment, thereby solving the challenge of identifying responsive patients while maintaining treatment effectiveness

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces subjective clinical assessment of patient responsiveness with objective sensor-based measurements. Instead of relying on manual evaluation of muscle response, the system uses accelerometers and EMG sensors to quantitatively measure pelvic floor muscle activity, thereby eliminating the difficulty of detecting responsiveness while ensuring reliable treatment identification

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

Data Source

PatentUS12502542B2Devices, systems, and methods for treating urinary and fecal incontinence
Publication Date: 2025.12.23 AXENA HEALTH INC
  • US12502542B2 patent drawing
  • US12502542B2 patent drawing
  • US12502542B2 patent drawing

AI summary

Featured are intravaginal devices and electrical stimulation devices, systems, thereof, and methods of using the devices and systems thereof to observe pelvic floor movements in order to diagnose, treat, or prevent urinary and fecal incontinence disorders (e.g., urge incontinence) and their accompanying symptoms or to diagnose and/or improve the efficacy of neuromodulation therapy.