Homogenous Silicone Elastomer Breast Implant Shell
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Solution Overview
Problem
Conventional silicone gel-filled breast implants face issues with gel bleed and delamination due to layered shell construction, which can result in visible clouding and reduced rupture resistance.
Innovation Solution
A single, homogenous layer of silicone elastomer with a polysiloxane backbone and a minimum mole percent of 10% substituted or pendant chemical groups, such as diphenyl groups, is used to create a shell that maintains strength when saturated with silicone gel, reducing gel bleed and delamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a layered or laminated shell construction is used to resist gel bleed, then gel bleed resistance is improved, but the shell may exhibit visible clouding and delamination
Solution Approach 1:
The patent merges multiple functional layers into a single homogenous silicone elastomer layer that provides both gel bleed resistance and structural integrity. The single layer construction eliminates the interface problems between layers while maintaining the barrier function against gel bleed through controlled composition (at least 10% substituted or pendant chemical groups).
Solution Approach 2:
The patent changes the chemical composition parameters of the silicone elastomer by incorporating at least 10% substituted or pendant chemical groups (such as phenyl, diphenyl, or trifluoropropyl groups) into the polymer structure. This compositional modification provides gel bleed resistance without requiring multiple layers, thereby eliminating clouding and delamination issues while maintaining transparency.
2Ease of manufacture
If a homogenous single layer shell is used to eliminate delamination and clouding, then shell transparency and structural integrity are improved, but gel bleed resistance may be compromised
Solution Approach 1:
The patent modifies the chemical composition of the silicone elastomer by incorporating at least 10% substituted or pendant chemical groups (phenyl, diphenyl, or trifluoropropyl groups) into the polymer structure. This compositional parameter change enables a single homogenous layer to provide both transparency and gel bleed resistance simultaneously, eliminating the need for multiple layers while maintaining reliability.
Solution Approach 2:
The patent creates a composite silicone elastomer material that combines the base polysiloxane backbone with substituted or pendant chemical groups. This composite material structure provides enhanced gel bleed resistance while maintaining the homogeneity and transparency of a single layer, effectively resolving the contradiction between simplicity and performance.
3Reliability
If silicone gel saturation is allowed to occur in the shell, then gel bleed resistance is improved, but shell tensile strength decreases
Solution Approach 1:
The patent changes the chemical structure of the silicone elastomer by incorporating at least 10% substituted or pendant chemical groups that maintain polymer chain strength even when saturated with silicone gel. These modified polymer structures resist the plasticizing effect of gel saturation, thereby maintaining tensile strength while allowing the shell to become saturated for optimal gel bleed resistance.
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 homogenous shell design achieves a lower gel bleed rate and comparable or increased tensile strength when saturated with silicone gel, compared to conventional layered shells, while eliminating the risk of delamination and clouding.
Implementation Method 1
having a minimum mole percent of at least 10% of a substituted or pendant chemical group that sterically retards permeation of said silicone gel through the layer
Data Source
Figure 1A~1C
Figure 2
Figure 3~6
AI summary
An elastomeric gel-filled prosthetic implant (10) having a shell made of a single gel barrier layer. The barrier layer (14) is formed of a homogeneous silicone elastomer capable of sterically retarding permeation of the silicone gel through the shell and having a bleed rate that is less than about 40% of the bleed rate of current shells which use a sandwiched construction with an internal barrier layer. Further, the barrier layer shell is made of a material that exhibits a wet strength that is comparable to or greater than current shells. The silicone elastomer may be a polydimethyl siloxane, and the substituted chemical group is a diphenyl group with a minimum mole percent of at least 13%. The implant may be designed for breast reconstruction or augmentation such that the shell is accordingly shaped. The shell wall thickness is at least 0.254 mm (0.010 inches), and desirably about 0.456 mm (0.018 inches). The implant shell may be made by dip-forming, spray-forming, or rotational molding. The exterior may be smooth or textured.