Inflatable Balloon Matrix for Custom Pessary Fitting

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Solution Overview

Problem

Current pessaries often suffer from suboptimal fit, leading to inadequate symptom control, discomfort, bleeding, discharge, vaginal erosions, and difficult removal, with existing fitting methods being inefficient and uncomfortable for patients.

Innovation Solution

A device featuring a matrix of individually inflatable spherical balloons that can be controllably filled to model the vagina's interior, allowing for personalized pessary design and fit, using fill volume and pressure data to determine optimal balloon positions and sizes, facilitating computer-aided design and production of customized pessaries.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If fixed sample sizes are used for in-office fitting, then the fitting process is efficient and non-invasive, but the pessary fit is suboptimal leading to discomfort and inadequate symptom control

Engineering Contradiction:
Improvepessary fit precisionVSAvoidfitting process complexity
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The invention transforms the static fixed-size pessary fitting approach into a dynamic, adaptive process using an inflatable balloon matrix that can be adjusted in real-time to match the patient's unique vaginal anatomy, enabling precise customization without requiring multiple fixed sample sizes

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the physical parameters of the fitting device by inflating and deflating individual balloons to different volumes, allowing the clinician to adaptively adjust the model to match the patient's anatomy and achieve optimal pessary fit precision

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If inflatable pessaries are used to achieve optimal size, then the fit can be customized, but the device is uncomfortable and requires frequent insertion and removal

Engineering Contradiction:
Improvepessary size customizationVSAvoidpatient comfort
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The invention segments the vaginal model into multiple individual balloons that can be independently inflated to different volumes, allowing precise adaptation to the patient's anatomy while maintaining overall structural integrity and patient comfort during the fitting process

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The balloon matrix creates a temporary copy or model of the patient's vaginal anatomy that can be measured and used to design a custom pessary, eliminating the need for the patient to wear an uncomfortable inflatable device long-term

Inventive Principle:
Principle #26Copying

3Device complexity

If traditional fixed-size pessaries are used, then the device structure is simple, but the fit is suboptimal causing discomfort, bleeding, and vaginal erosions

Engineering Contradiction:
Improvepessary structure simplicityVSAvoidpatient discomfort and complications
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

Solution Approach 1:

The invention performs preliminary action by creating an accurate 3D model of the patient's vaginal anatomy using the balloon matrix before pessary fabrication, ensuring the final pessary is precisely customized to the patient's anatomy and avoids complications from poor fit

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS10687977B1Device and method to optimize the form and function of a pessary
Publication Date: 2020.06.23 FP MEDTECH INC
  • US10687977B1 patent drawing
  • US10687977B1 patent drawing
  • US10687977B1 patent drawing

AI summary

A device for modeling a pessary is disclosed. A matrix of individually expandable balloons are mounted around a shaft, which holds fill lines for each balloon. The balloons are expandable with fluid to a desired volume and/or pressure, according to comfort and fit determined by real-time patient feedback. Because the volumes and the positions of the balloons are known, a calculation of the dimensions of the vaginal canal can be made, so that the matrix of expandable balloons models the vaginal canal.