Variable Texture Prosthesis Shell for Capsular Contracture

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Solution Overview

Problem

Current breast implants face complications such as capsular contracture due to fibrous capsule contraction, which can render implants spherical and stiff, and there is a need for improved tissue integration and adhesion to enhance their natural movement and comfort within the body.

Innovation Solution

The development of a breast implant with discrete fixation regions on its exterior surface, featuring varying textures and open cell structures to encourage enhanced tissue ingrowth and adhesion, while also disrupting capsular tissue formation, thereby reducing the risk of capsular contracture and improving implant mobility and comfort.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a smooth surface is used for the implant shell, then the implant is easier to manufacture and insert, but it increases the risk of capsular contracture and reduces tissue integration

Engineering Contradiction:
Improvecapsular contracture resistanceVSAvoidsurface fabrication complexity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The implant shell incorporates discrete fixation regions with textured surfaces at specific locations (anterior and/or posterior faces) while maintaining smooth or less textured adjacent surfaces. This local differentiation provides targeted tissue ingrowth and adhesion promotion where needed, while preserving ease of manufacture in other areas.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The shell surface is divided into distinct regions with different textures - fixation regions with enhanced texture for tissue adhesion and non-fixation regions with smoother surfaces. This segmentation allows the implant to provide localized functionality without requiring the entire surface to be complex.

Inventive Principle:
Principle #1Segmentation

2Reliability

If a uniformly textured surface is applied to the entire implant, then tissue ingrowth is maximized, but the implant loses natural movement and increases wear from material stresses

Engineering Contradiction:
Improvetissue integrationVSAvoidimplant mobility and wear resistance
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

Different regions of the implant shell are assigned different texture characteristics - fixation regions with enhanced texture for tissue ingrowth and adhesion, and non-fixation regions with smoother surfaces that allow natural movement and reduce stress concentration, thereby extending implant durability.

Inventive Principle:
Principle #3Local quality

3Reliability

If fixation regions with enhanced texture are created on the implant shell, then tissue adhesion is improved, but the manufacturing process becomes more complex

Engineering Contradiction:
Improvetissue adhesionVSAvoidsurface texture variation
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The shell is constructed with discrete fixation regions having enhanced texture applied only to specific surfaces (anterior and/or posterior faces) rather than uniformly across the entire implant, providing targeted tissue adhesion while limiting manufacturing complexity to localized areas.

Inventive Principle:
Principle #3Local quality

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 textured surface design promotes natural movement of the implant with the body, reduces wear from material stresses, and enhances patient comfort by encouraging different degrees of tissue interaction and adhesion, potentially minimizing capsular contracture and improving aesthetic outcomes.

Implementation Method 1

the fixation surfaces are discrete surface portions extending across an anterior face or a posterior face of the implant. These fixation surfaces, sometimes herein referred to as 'fixation regions,' are generally defined by a texture, roughness or sheen that is different from a texture, roughness or sheen of adjacent surface portions of the implant

Methodology Applied
Scientific EffectMechanical interlocking:

Data Source

PatentEP3142602B1Soft filled prosthesis shell with variable texture
Publication Date: 2020.02.12 ALLERGAN INC
  • EP3142602B1 patent drawingFigure 1A~2B
  • EP3142602B1 patent drawingFigure 3A~3B
  • EP3142602B1 patent drawingFigure 4A~4B

AI summary

A soft prosthetic implant, such as a silicone breast implant, is provided. The implant has a variety of different surfaces, for example, different textures, located on different areas of the outer surface of the implant.