Adjustable Vaginal Pessary with Inflatable Support

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Solution Overview

Problem

Current pessaries for pelvic organ prolapse treatment often fail due to improper fit, leading to side effects such as pain, erosion, and difficulty in self-management, with a high recurrence rate and need for frequent medical visits.

Innovation Solution

A vaginal device with an adjustable structure comprising an elongated base element, an inflatable element, and support members that can be customized to individual patient anatomy, allowing for easy insertion and adjustment, reducing peak pressure, and incorporating a fluid channel and valve system for controlled inflation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If standard pessaries are used for pelvic organ prolapse treatment, then treatment coverage is provided, but improper fit leads to side effects such as pain, erosion, and difficulty in self-management

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidself-management capability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The pessary incorporates an adjustable mechanism that allows the device to be dynamically modified after insertion. The adjustment system enables patients to self-adjust the pessary's fit and positioning, transforming a static device into a dynamic one that adapts to individual anatomical variations and comfort needs, thereby improving both reliability and ease of operation

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention changes key parameters of the pessary such as diameter, depth, and support element positioning. These parameter adjustments are made possible through an adjustable mechanism that allows customization to match individual patient anatomy, resolving the contradiction between providing effective treatment and ensuring proper fit to avoid side effects

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If adjustable mechanisms are added to customize pessary fit, then patient comfort and fit improve, but device complexity increases

Engineering Contradiction:
Improvecustomizability to individual anatomyVSAvoidnumber of adjustable components
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The pessary is divided into distinct functional segments: a base element, support elements, and an adjustment mechanism. This segmentation allows each component to perform its specific function independently, making the overall adjustable system more manageable and less complex than a fully integrated adjustable device

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The adjustment mechanism is designed to be operated by the patient themselves without requiring medical intervention. This self-service capability simplifies the device by eliminating the need for complex external adjustment systems or frequent clinical visits, thereby improving adaptability while controlling device complexity

Inventive Principle:
Principle #25Self-service

3Ease of operation

If pessary diameter is reduced for easier insertion, then insertion and extraction become less painful, but structural support capability may be compromised

Engineering Contradiction:
Improveinsertion and extraction easeVSAvoidstructural support for pelvic organs
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The pessary employs nested support elements that can be inserted within the base structure. These nested elements provide additional structural support without significantly increasing the overall external diameter of the device, thus maintaining ease of insertion while ensuring adequate pelvic organ support

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

Instead of increasing diameter to improve support, the invention adds support in another dimension through vertically extending support elements. This dimensional approach provides necessary structural strength while keeping the pessary's cross-sectional diameter small for comfortable insertion and extraction

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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 provides a comfortable, effective, and patient-friendly solution for pelvic organ prolapse treatment, reducing side effects, outpatient visits, and surgical needs, while allowing for self-management and cost savings.

Implementation Method 1

an inflatable element (3) attached to a distal end part (2a) of the elongated base element (2)

Methodology Applied
Scientific EffectPneumatic pressure: Pressurisation

Data Source

PatentEP3906900B1Vaginal device for prolapse treatment
Publication Date: 2023.10.11 STICHTING RADBOUD UNIVERSITAIR MEDISCH CENT
  • EP3906900B1 patent drawingFigure 1
  • EP3906900B1 patent drawingFigure 2
  • EP3906900B1 patent drawingFigure 3

AI summary

Vaginal device (1) for pelvic organ prolapse treatment, having an elongated base element (2), an inflatable element (3) attached to a distal end part (2a) of the elongated base element, and a support element (4) attached to a proximal end part (2b) of the elongated base element. The support element has at least two support members (5), which extend away from the proximal end of the elongated base element.