Composite ePTFE Silicone Breast Implant Reduces Capsular Contracture

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Solution Overview

Problem

Current breast implants face issues with capsular contracture, infection rates, and palpability due to textured surfaces, which can lead to undesirable outcomes such as firmness, distortion, pain, and increased risk of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) and biofilm formation.

Innovation Solution

A composite ePTFE and silicone implant with a smooth, microporous ePTFE outer layer that discourages tissue adherence and biofilm formation, reducing capsular contracture and infection risks, while providing a softer, lighter, and more biocompatible option that mimics natural tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If textured surfaces are used on breast implants, then tissue adherence and stability are improved, but capsular contracture and firmness increase

Engineering Contradiction:

Improvetissue adherenceVSAvoidcapsular contracture

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The implant surface is designed with varying degrees of texture in different zones. The outer surface has a textured pattern to promote tissue adherence and stability, while the inner surface remains smoother to reduce capsular contracture. This local differentiation allows the implant to simultaneously achieve both tissue stability and reduced contracture risk.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The implant combines multiple materials with different surface properties. The shell is made of silicone elastomer with a textured outer layer and a smoother inner layer. This composite structure allows the outer surface to provide tissue adherence while the inner surface minimizes capsular contracture, resolving the contradiction between stability and harmful effects.

Inventive Principle:

Principle #40Composite materials

2Reliability

If textured surfaces are used on breast implants, then tissue integration is improved, but infection risk and biofilm formation increase

Engineering Contradiction:

Improvetissue integrationVSAvoidinfection risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The implant incorporates an antibiotic-impregnated outer shell that provides infection protection during the critical early postoperative period. The antibiotics are released over time to prevent biofilm formation, after which the protective function diminishes. This temporary protective measure addresses the infection risk associated with textured surfaces during the most vulnerable period.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Object-affected harmful factors

If smooth surfaces are used on breast implants, then infection risk is reduced, but tissue adherence and stability decrease

Engineering Contradiction:

Improveinfection riskVSAvoidtissue adherence

Core Design Contradiction:

Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

Inventive Principle:

Principle #40Composite materials

4Strength

If heavier materials are used on breast implants, then structural integrity is improved, but palpability and natural feel increase

Engineering Contradiction:

Improvestructural integrityVSAvoidpalpability

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The implant uses silicone elastomer with optimized physical properties including specific gravity between 0.9-1.1 g/cm³ to match natural breast tissue density. The material parameters are carefully selected to provide sufficient structural integrity while maintaining weight characteristics that minimize palpability and create a natural feel.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS20240374788A1COMPOSITE ePTFE AND SILICONE SOFT TISSUE IMPLANTS TO MINIMIZE CAPSULAR CONTRACTURE, WEIGHT, INFECTION AND PALPABILITY

Publication Date: 2024.11.14 ANTON MARK A

AI summary

Methods, systems, apparatuses and devices for implantation in a soft-tissue biological environment that include a primary layer for containing a filler substance, an interface and a secondary layer, including embodiments where the secondary layer an ePTFE layer, the primary layer is a silicone layer, the interface is mechanical or adhesive and the filler substance can include particulates and lattices.