Inflatable Vaginal Pessary with Integrated Capillary Douching System

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Solution Overview

Problem

Existing vaginal pessaries for pelvic organ prolapse (POP) face challenges with difficult insertion and extraction, air leakage, and the need for regular removal for cleaning, which can lead to infections and complications.

Innovation Solution

A vaginal pessary with a deformable or inflatable design and integrated douche system, allowing easy insertion and connection to an irrigation unit for in-situ cleaning without removal, using elastic or inflatable materials and coupling means for fluid distribution.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the pessary is made wide to serve as a mechanical barrier preventing extrusion of pelvic organs, then the anti-prolapse support function is improved, but the difficulty and pain during insertion and removal increases

Engineering Contradiction:
Improveanti-prolapse support functionVSAvoidinsertion and removal ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The pessary incorporates an inflatable element that can be deflated for insertion and then inflated to provide mechanical support. This dynamic transformation allows the device to be inserted in a compact state and then expanded to achieve the necessary width for effective prolapse support, resolving the contradiction between ease of insertion and mechanical barrier function

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The inflatable element is nested within a containment structure that guides insertion. The collapsible nature of the inflatable element allows it to be compressed into a smaller form factor for insertion, then expanded to provide the required mechanical support, effectively nesting the functional form within the insertion form

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If the pessary remains in situ for prolonged use, then the mechanical support function is maintained, but the risk of vaginal dryness, infections and complications increases

Engineering Contradiction:
Improvemechanical support continuityVSAvoidinfection and irritation risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The pessary incorporates an integrated douching system with a tubular element containing holes for fluid distribution. This self-service capability allows the user to perform hygienic cleaning of the vaginal area while the pessary remains in situ, eliminating the need for removal and reinsertion for cleaning purposes, thus maintaining continuous mechanical support while reducing infection risk

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The pessary combines multiple functions: mechanical support for prolapse correction and integrated hygiene maintenance through the douching system. The tubular element serves both as part of the structural framework and as a fluid distribution system, allowing the single device to perform both support and cleaning functions simultaneously

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

3Strength

If the pessary is made of solid material to provide mechanical barrier, then the structural strength is improved, but the ability to facilitate easy insertion and extraction deteriorates

Engineering Contradiction:
Improvestructural strengthVSAvoidinsertion and extraction ease
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The pessary uses an inflatable element that transitions from a deflated flexible state during insertion to an inflated rigid state during use. This dynamic property allows the material to be flexible when needed for insertion and then become structurally strong for providing mechanical support, resolving the contradiction between ease of operation and structural strength

Inventive Principle:
Principle #15Dynamics

4Reliability

If the pessary requires regular removal for cleaning, then the hygiene maintenance is improved, but the frequency of insertion and extraction maneuvers increases, leading to more irritation and potential complications

Engineering Contradiction:
Improvehygiene maintenanceVSAvoidfrequency of manipulation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The integrated douching system enables the user to perform hygienic cleaning of the vaginal area while the pessary remains in place. This self-service cleaning capability eliminates the need for repeated removal and reinsertion maneuvers, maintaining hygiene effectiveness while reducing mechanical irritation from frequent manipulation

Inventive Principle:
Principle #25Self-service

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

Facilitates easy insertion and cleaning in situ, reducing infection risk and maintaining mechanical support for pelvic organs, while preventing air leakage and simplifying hygiene maintenance.

Implementation Method 1

a tubular element, closed at its ends, which follows and is attached to the profile of said deck, and is provided with an array of holes appropriately distanced for the distribution of a vaginal douche

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

a tube for introducing the douching liquid into such a tubular element from the outside

Methodology Applied
Scientific EffectPressure-driven flow: Pressure Gradient

Implementation Method 3

The body may also comprise a plurality of inflatable elements arranged in various configurations and connected to inflating tubes

Methodology Applied
Scientific EffectGas pressure expansion: Pressurisation

Implementation Method 4

a deck ergonomically shaped to adapt to the vaginal morphology

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP4401687B1Endovaginal device for the correction of bladder and uterine prolapse incorporating a self-washing system with vaginal douches
Publication Date: 2025.11.05 ADL FARMACEUTICI SRL
  • EP4401687B1 patent drawingFigure 1A~1B
  • EP4401687B1 patent drawingFigure 2A~2B
  • EP4401687B1 patent drawingFigure 3~7

AI summary

A device for the treatment of pelvic organ prolapse in women integrating a|passive system aimed at providing mechanical support to the walls of the vagina, |with a douching system of the vagina itself by capillary douche irrigation along|the vaginal walls, preventing complications arising from the prolonged presence of current vaginal pessaries, such as irritation, erosion, bleeding and malodorous discharge. Said pessary consists of a multilevel body comprising: a deck (2) ergonomically shaped to adapt to the vaginal morphology, which provides|the function of anti-prolapse support; a tubular element (28), closed at its ends, which follows and is integral with the profile of said deck, and is|provided with an array of holes (32) for the distribution of a douche on the|walls of the vagina, and a tube (34) protruding from said tubular element to|introduce said douche into said tubular element from the outside, leaving said pessary in situ.