Variable Texture Prosthesis Shell for Capsular Contracture

Solution Overview

Problem

Current breast implants face complications such as capsular contracture due to fibrous capsule contraction, which can render the implant spherical and aesthetically undesirable, and there is a need for improved tissue integration and adhesion to enhance comfort and reduce wear from material stresses.

Innovation Solution

A breast implant with an elastomeric shell featuring discrete fixation regions on its exterior surface, providing enhanced texture and roughness to encourage tissue ingrowth and adhesion, while the balance of the surface remains relatively smooth or less textured, disrupting capsular tissue formation and aligning with muscle groups for natural movement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a textured surface is applied to the entire implant, then tissue ingrowth and adhesion are enhanced, but capsular contracture resistance is reduced

Engineering Contradiction:

Improvetissue adhesionVSAvoidcapsular contracture

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The implant surface is divided into distinct regions with different textures: a textured fixation region that promotes tissue ingrowth and adhesion, and a smooth region that resists capsular contracture. This local differentiation allows each region to perform its specific function optimally without compromising the other.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The implant shell surface is segmented into functionally distinct zones - a fixation region with enhanced texture for tissue anchoring and a smooth region for capsular contracture resistance. This segmentation enables the implant to simultaneously achieve both tissue integration and contracture prevention.

Inventive Principle:

Principle #1Segmentation

2Object-affected harmful factors

If a smooth surface is used for the implant, then capsular contracture is reduced, but tissue integration and adhesion are insufficient

Engineering Contradiction:

Improvecapsular contractureVSAvoidtissue adhesion

Core Design Contradiction:

Object-affected harmful factorsVSStrength

Solution Approach 1:

The implant surface is divided into distinct regions with different textures: a textured fixation region that promotes tissue ingrowth and adhesion, and a smooth region that resists capsular contracture. This local differentiation allows each region to perform its specific function optimally without compromising the other.

Inventive Principle:

Principle #3Local quality

3Adaptability or versatility

If the implant moves independently from body muscles, then implant positioning is flexible, but wear from material stresses increases and comfort decreases

Engineering Contradiction:

Improveimplant positioningVSAvoidwear resistance

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The implant surface is divided into distinct regions with different textures: a textured fixation region that promotes tissue ingrowth and adhesion, and a smooth region that resists capsular contracture. This local differentiation allows each region to perform its specific function optimally without compromising the other.

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 implant promotes natural movement with the body, reduces wear, and enhances comfort by encouraging tissue integration and adhesion, potentially lowering the risk of capsular contracture and improving aesthetic outcomes.

Implementation Method 1

fixation regions defined by a texture, roughness or sheen that is different from a texture, roughness or sheen of adjacent surface portions of the implant... configured, positioned or structured to provide enhanced or controlled tissue ingrowth or adhesion

Methodology Applied

Scientific EffectTissue ingrowth:

Implementation Method 2

the balance of the exterior surface may be relatively less textured than the fixation regions... the surface or surfaces that are not defined by the fixation regions, are substantially less textured, or are relatively smooth

Methodology Applied

Scientific EffectCapsular contracture disruption:

Data Source

PatentUS9808338B2Soft filled prosthesis shell with variable texture

Publication Date: 2017.11.07 ALLERGAN INC

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.