Flexible Cone-Shaped Vaginal Insert for Prolapse Management

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Solution Overview

Problem

Current vaginal pessaries for managing pelvic organ prolapse and urinary incontinence are difficult to insert and remove, uncomfortable, and require frequent physician visits, with potential complications such as mesh erosion and scarring, necessitating a non-absorbent, easy-to-use, and comfortable alternative.

Innovation Solution

A vaginal insert device made of elastic, non-absorbent material with a cone-shaped body and a stem-like removal portion, featuring a compact design for easy insertion and expansion for secure fit, along with ventilation openings and an exterior rim for comfort and ease of use, allowing for self-insertion and removal with minimal physician intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional pessaries are used to manage pelvic organ prolapse and urinary incontinence, then treatment effectiveness is achieved, but insertion and removal difficulty increases and patient comfort decreases

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidinsertion and removal ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The pessary is divided into distinct functional segments: a bell-shaped main body for anatomical support and a separate stem for external manipulation. This segmentation allows the support structure to maintain its structural integrity for effective treatment while the stem provides an external interface for easy patient-controlled insertion and removal without requiring physician assistance.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The stem acts as an intermediary element between the patient's external environment and the internal pessary body. This intermediary structure with external loops or knobs allows the patient to grasp and manipulate the device for insertion and removal, eliminating the need for direct manual insertion into the vagina and reducing insertion difficulty while maintaining treatment reliability.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Duration of action of stationary object

If traditional pessaries are used for extended periods, then treatment continuity is maintained, but patient comfort and convenience deteriorate

Engineering Contradiction:
Improvetreatment continuityVSAvoidpatient convenience
Core Design Contradiction:
Duration of action of stationary objectVSEase of operation

Solution Approach 1:

The pessary design enables self-service by incorporating an external stem with manipulation features that allow patients to independently insert and remove the device. This eliminates the need for repeated physician visits for device management, maintaining treatment continuity while significantly improving patient convenience and comfort during extended use periods.

Inventive Principle:
Principle #25Self-service

3Reliability

If surgical mesh is used to treat pelvic organ prolapse and urinary incontinence, then symptom amelioration is achieved, but complication risks increase

Engineering Contradiction:
Improvesymptom ameliorationVSAvoidcomplication risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The pessary offers a non-surgical, removable alternative to permanent surgical mesh implants. By using a disposable or reusable but removable device that can be taken out and cleaned, the design eliminates risks associated with permanent implantation such as mesh erosion, chronic pain, and infection, while still providing effective symptom amelioration through mechanical support.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The pessary can be removed, cleaned, and reused or discarded according to patient needs and hygiene requirements. This recoverable and replaceable nature eliminates the permanent foreign body presence that causes surgical mesh complications, while maintaining treatment effectiveness through repeated use cycles.

Inventive Principle:
Principle #34Discarding and recovering

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 effectively manages or eliminates symptoms of pelvic organ prolapse and urinary incontinence, providing comfort and convenience with reduced risk of complications, as it is easy to insert and remove, non-absorbent to prevent odor and bacterial growth, and can be reused or disposed of, eliminating the need for prescriptions.

Implementation Method 1

The wall expands back to its original shape after insertion

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3337434B1Flexible cone-shaped intra-vaginal support device
Publication Date: 2023.10.18 WATKINS CONTI PRODUCTS INC
  • EP3337434B1 patent drawingFigure 1
  • EP3337434B1 patent drawingFigure 2
  • EP3337434B1 patent drawingFigure 3

AI summary

A flexible, nonabsorbent vaginal insert shaped to be held securely in a vagina, improves symptoms of pelvic organ prolapse or urinary incontinence. The device is easy to insert. An applicator may be used to aid insertion. The insert device comprises an upper portion, having a cone-shaped body, a circular transverse cross-section, a wall with an interior and exterior side, upper open end, lower end, hollow interior, the upper open end is the innermost portion during insertion, the wall of the upper portion can be squeezed to make the upper portion compact for easier insertion, after insertion the wall expands back to its original shape. The device comprises an exterior rim surrounding and protruding from the exterior of the wall and adjacent the upper open end, a plurality of ridges surrounding and protruding from the exterior of the wall, a removal portion extending from said lower end to assist in removal. The device can comprise one or more ventilation openings.