Breast Implant Surface Texture for Lower Capsular Contracture

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Solution Overview

Problem

Current breast implants face challenges with capsular contracture and adverse cellular responses due to the formation of fibrous capsules, which can lead to implant failure and complications such as firmness, deformation, and pain, and are difficult to address with existing textured surface technologies that often result in excessive tissue ingrowth and surgical trauma.

Innovation Solution

The development of biomimetic textured surface topographies for implants that mimic the surface features of human skin, specifically controlling macro, micro, and nano-scale roughness to promote desirable cellular responses, reduce capsular contraction, and facilitate easier surgical removal by minimizing tissue loss.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If textured silicone implant surfaces are used to reduce capsular contracture, then the incidence of capsular contracture formation is lowered, but excessive tissue ingrowth occurs leading to surgical trauma during removal

Engineering Contradiction:
Improvecapsular contracture preventionVSAvoidtissue ingrowth and surgical trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The implant surface features controlled local variations in roughness with specific parameters (Ra 0.5-2.0 μm, Rz 2-8 μm) to create optimal cellular interaction zones that prevent capsular contracture while minimizing excessive tissue ingrowth

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent applies specific quantitative parameters for surface roughness (Ra, Rz, Sa, Sz values) to optimize the textured surface properties, changing the physical characteristics of the implant surface to achieve the desired balance between contracture prevention and tissue compatibility

Inventive Principle:
Principle #35Parameter changes

2Reliability

If heavily textured implant surfaces are used to disrupt parallel collagen fibre formation, then capsular contraction is prevented, but excessive tissue ingrowth into the implant occurs

Engineering Contradiction:
Improvecapsular contraction preventionVSAvoidtissue ingrowth
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent defines specific parameter ranges for surface roughness (Ra 0.5-2.0 μm, Rz 2-8 μm) to optimize the textured surface, changing the physical characteristics to prevent both capsular contraction and excessive tissue ingrowth

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The implant surface mimics the natural extracellular matrix structure with controlled roughness features that replicate physiological conditions, promoting desirable cellular behavior without triggering excessive tissue response

Inventive Principle:
Principle #26Copying

3Stability of the object's composition

If textured surfaces are used to firmly integrate the implant within breast tissue, then implant stability is improved, but surgical removal becomes more traumatic

Engineering Contradiction:
Improveimplant integrationVSAvoidsurgical trauma
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The controlled surface roughness creates localized zones for optimal cellular attachment and integration while maintaining overall surface properties that prevent excessive tissue ingrowth, achieving balance between stability and removability

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP3750507B1Textured surfaces for breast implants
Publication Date: 2024.06.05 ESTABLISHMENT LABS SA
  • EP3750507B1 patent drawingFigure 1~2
  • EP3750507B1 patent drawingFigure 3~4
  • EP3750507B1 patent drawingFigure 5~6

AI summary

The invention provides new devices for implantation in a patient having irregular textured surfaces, which devices show significantly improved cellular response compared to conventional smooth and textured implants, indicating that significantly improved biocompatibility would be achieved in vivo. Methods for making such new devices and surface textures are also disclosed.