Biological Mesh Fixing System for Breast Prosthesis

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Solution Overview

Problem

Current prostheses, such as silicone breast prostheses, often suffer from capsular contracture due to foreign body reactions, leading to deformation and the need for additional surgical interventions, and existing solutions for reducing this issue, like collagen mesh coverings, lack a stable and secure fixing system, risking contamination and integrity compromise during handling.

Innovation Solution

A mesh or membrane covering based on biological or biosynthetic material with a secure fixing system featuring a plurality of foldable teeth or petals that securely attach to the prosthesis, allowing for neovascularization and integration, reducing the risk of capsular contracture and contamination, and enabling easier handling and reduced surgery times.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a collagen mesh covering is used to wrap the prosthesis, then the risk of capsular contracture is reduced, but the fixing system is unstable and the prosthesis may separate from the covering

Engineering Contradiction:

Improvestability of covering-prosthesis attachmentVSAvoidcapsular contracture

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The fixing system is divided into multiple independent teeth or petals distributed around the prosthesis circumference. Each tooth/petal acts as an independent anchoring element that penetrates or engages with the prosthesis surface, collectively providing stable fixation while allowing the covering to conform to the prosthesis shape.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Instead of attaching the covering to the prosthesis through traditional sutures or adhesives from the outside, the fixing teeth/petals are integrated into the covering structure itself and engage with the prosthesis surface directly, inverting the conventional attachment approach to achieve more reliable bonding.

Inventive Principle:

Principle #13The other way round (Inversion)

2Ease of operation

If the prosthesis is prepared and handled in the operating theatre, then the covering can be applied, but the prosthesis is exposed to contamination risk and handling time increases

Engineering Contradiction:

Improveease of covering applicationVSAvoidcontamination risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The covering is pre-assembled with the fixing teeth/petals integrated into its structure before the surgical procedure. This preliminary preparation allows the covering to be applied as a complete unit to the prosthesis, minimizing the time and manual handling required during the operating theatre procedure and thereby reducing contamination risk.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If traditional suturing methods are used to attach the covering, then the prosthesis can be secured, but the integrity of the prosthesis is compromised due to needle pricking

Engineering Contradiction:

Improvesecuring of covering to prosthesisVSAvoidintegrity of prosthesis

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The fixing teeth/petals serve as intermediary elements that mediate the attachment between the covering and prosthesis. Instead of using needles that directly penetrate and potentially damage the prosthesis, the teeth/petals engage with the prosthesis surface in a manner that secures the covering while preserving prosthesis integrity.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 solution effectively reduces the occurrence of capsular contracture, minimizes surgical intervention, and enhances the handling and integration of prostheses by providing a stable and secure attachment system, while also reducing contamination risks and surgery times.

Implementation Method 1

allowing for neovascularization and integration

Methodology Applied

Scientific EffectNeovascularization:

Data Source

PatentUS12004942B2Mesh or membrane covering based on biological or biosynthetic material for prosthesis, provided with fixing system for fixing to the same prosthesis, and corresponding manufacturing process thereof

Publication Date: 2024.06.11 NANNI FLAVIO

AI summary

The present invention relates to a mesh or membrane covering (2) based on biological material, for example collagen, or biosynthetic material for prostheses (1), in particular for a breast prosthesis (1), said prosthesis (1) having a rear surface that, when applied, is faced towards the person on whom (1) is applied, said covering (2) being characterized in that it provides a fixing system (4; 3) for fixing to said prosthesis (1), said fixing system providing a plurality of teeth or petals (4) or outer perimeter edge foldable on said rear surface of the prosthesis (1) by means (5). The invention further relates to a method for fixing said covering to a prosthesis, a prosthesis comprising said covering and a process for making said covering.