Neovaginal Prosthesis with Rounded End and Drainage Orifices

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Solution Overview

Problem

Current vaginal prostheses used in vaginoplasty procedures are anatomically unsuitable, heavy, uncomfortable, and often require external skin coatings, which can cause complications such as ulcers and retraction, necessitating invasive skin grafts and leaving scars.

Innovation Solution

A cylindrical, hollow neovaginal prosthesis with a rounded upper end and side notch for urethra protection, made from biocompatible polylactic acid via 3D printing, which minimally protrudes and uses a biodegradable mesh for coating instead of skin grafts, reducing invasiveness and discomfort.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional prostheses are used with external skin coatings, then the neovaginal cavity can be covered and maintained, but the patient experiences discomfort, heavy weight, and risk of ulcers and decubitus

Engineering Contradiction:
Improvecoverage of neovaginal cavityVSAvoidpatient comfort
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention removes the skin graft component entirely from the prosthesis design. Instead of coating the prosthesis with patient skin, the design uses a bare medical-grade polymer prosthesis that maintains the neovaginal cavity without requiring external biological coatings, thereby eliminating sources of discomfort and complications.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The prosthesis uses modern medical-grade polymers with improved mechanical properties that allow for reduced weight while maintaining structural integrity and coverage function. The material properties have been optimized to provide adequate support without the heavy weight of traditional designs.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If skin grafts are used to cover the prosthesis, then the neoformed vaginal space can be epithelialized, but invasive surgery with scars and complications is required

Engineering Contradiction:
Improveepithelialization of vaginal spaceVSAvoidsurgical invasiveness
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The skin graft step is completely extracted from the surgical procedure. The prosthesis design eliminates the need for taking skin from the patient's body, preparing skin grafts, attaching them to the prosthesis, and managing their integration. The prosthesis functions effectively without any biological coating.

Inventive Principle:
Principle #2Taking out (Extraction)

3Stability of the object's composition

If the prosthesis has a fixed rigid structure, then it can maintain the neovaginal cavity shape, but it causes discomfort and retraction of luminar diameter

Engineering Contradiction:
Improvemaintenance of vaginal cavity shapeVSAvoidpatient comfort and adaptability
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The prosthesis incorporates dynamic characteristics through its structural design that allows controlled flexibility and adaptation to patient movements and physiological changes, while maintaining overall cavity shape stability. The design balances rigidity for shape maintenance with flexibility for comfort.

Inventive Principle:
Principle #15Dynamics

4Reliability

If the prosthesis protrudes significantly from the vaginal opening, then it can be easily secured and positioned, but it causes discomfort and safety issues for the patient

Engineering Contradiction:
Improvepositioning and securing of prosthesisVSAvoidpatient comfort and safety
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The prosthesis dimensions have been optimized to achieve adequate securing with minimal protrusion. The size and shape parameters were adjusted to find the optimal balance between being sufficiently visible for positioning and secure, versus protruding so much as to cause discomfort or safety issues.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3466371B1Neovaginal prosthesis
Publication Date: 2021.03.31 FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA
  • EP3466371B1 patent drawingFigure 1~3
  • EP3466371B1 patent drawingFigure 4

AI summary

Neovaginal prosthesis, designed to be temporarily inserted in a space defined between the bladder and the rectum of women with vaginal agenesis and in sex-change operations by means of the surgical intervention known as Mclndoe technique, to create an artificial vaginal cavity or neovagina with a suitable luminal diameter. The neovaginal prosthesis comprises an essentially cylindrical hollow main body, with external diametric dimensions in reduction from a first upper end to a second lower end. The upper end is designed to be inserted inside the surgically defined space, and said upper end has an essentially rounded geometry, with a first through-orifice defined in its surface for drainage of liquids and secretions towards the outside. The lower end remains outside, protruding slightly from the vaginal opening and said lower end comprises a second through-orifice to allow the exit of the liquids collected.