Elastomeric Membrane Implant with Cohesive Gel
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Solution Overview
Problem
Existing breast implants face challenges in providing a natural feel and appearance while ensuring biocompatibility and ease of manufacturing, particularly in reducing capsular contraction and tissue toxicity.
Innovation Solution
The development of an adjustable implant with an elastomeric membrane featuring a textured exterior surface, comprising an outer zone and an inner zone formed from multiple elastomeric layers, which expands to enclose a volume greater than its initial form, exerting a contracting force on a cohesive gel within the implant.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If saline is used as filling material to eliminate fluid bleed complications, then biocompatibility is improved, but fluid motion causes deformation and rippling visible through tissue
Solution Approach 1:
The patent changes the physical parameters of the filling material by using a cohesive gel with high viscosity instead of saline. This parameter change reduces fluid motion and eliminates rippling while maintaining biocompatibility. The gel's cohesive properties allow it to maintain shape and volume without the harmful fluid dynamics of saline.
Solution Approach 2:
The patent employs a composite structure combining elastomeric membrane layers with cohesive gel filling. The multi-layer membrane provides structural support and natural feel, while the cohesive gel provides the filling function with improved physical properties. This composite approach resolves the contradiction by integrating the benefits of both materials.
2Shape
If gel is used as filling material to provide natural appearance, then aesthetic properties are improved, but gel bleed causes capsular contraction and tissue toxicity
Solution Approach 1:
The patent uses a composite structure with multiple elastomeric membrane layers surrounding the cohesive gel. This layered composite design provides the natural appearance of gel-filled implants while the additional membrane layers act as barriers to prevent gel bleed and capsular contraction, eliminating tissue toxicity.
Solution Approach 2:
The patent employs flexible elastomeric membrane shells in a multi-layer configuration. These shells provide the necessary containment to prevent gel leakage while maintaining the natural feel and appearance. The membrane layers are sufficiently thin to allow natural deformation but thick enough to prevent gel bleed.
3Adaptability or versatility
If multi-chamber design is used to increase size and shape variability, then adaptability is improved, but resistance to shear forces decreases at membrane junctions
Solution Approach 1:
The patent uses composite elastomeric materials with enhanced shear strength properties in the membrane layers. This allows the multi-chamber design to maintain its size and shape variability while the advanced material composition provides sufficient shear force resistance at the membrane junctions to prevent failure.
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 achieves a natural feel and appearance by balancing contracting and outward forces, reducing the occurrence of rippling, and providing improved biocompatibility and manufacturing efficiency.
Implementation Method 1
an elastomeric membrane featuring a textured exterior surface, comprising an outer zone and an inner zone formed from multiple elastomeric layers, which expands to enclose a volume greater than its initial form, exerting a contracting force on a cohesive gel within the implant
Data Source
AI summary
A method of forming an implant includes providing a preformed shell formed from at least one cured elastomeric layer. The shell includes an outer surface, an inner surface, and an opening for accessing an interior volume of the shell. The method further includes expanding the shell to an expanded state, in which the interior volume is greater than the interior volume of the shell at a time of forming the shell and forming an inner zone having at least one inner elastomeric layer on at least a portion of the inner surface of the shell, while the shell is in the expanded state, thereby forming a multi-zone shell. The method further includes reducing the interior volume of the multi-zone shell, thereby contracting the at least one inner elastomeric layer of the inner zone and causing texturing of the at least one inner elastomeric layer.