Silicone Gel–Elastomer Breast Prosthesis for Secure, Comfortable Fit
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Solution Overview
Problem
Existing breast prostheses made of silicone gel or elastomer face issues such as shifting, discomfort, skin irritation, poor adhesion, and cumbersome design, particularly when combining both materials.
Innovation Solution
A breast prosthesis combining encapsulated silicone gel and silicone elastomer, with a firm elastomer back for secure wear and a soft gel front for comfort, using a two-chamber bag process with polytetrafluoroethylene, polyurethane layers, and a heat-sealing method to ensure adhesion and durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If silicone gel is used to mimic fatty tissue feel and movement, then comfort is improved, but the prosthesis shifts and moves around inside the bra pocket
Solution Approach 1:
The breast prosthesis is divided into two distinct parts: a soft silicone gel part (mimicking fatty tissue) and a firm silicone elastomer part (提供稳定支撑). This segmentation allows each part to fulfill its specific function - the gel provides comfort while the elastomer provides stability, resolving the contradiction between comfort and position stability.
Solution Approach 2:
Different regions of the prosthesis are assigned different material properties: the front portion uses soft silicone gel for comfort and natural feel, while the back portion uses firm silicone elastomer for stability and secure fit. This local differentiation of material quality allows the prosthesis to simultaneously achieve both comfort and position stability.
2Reliability
If silicone gel is encapsulated in flexible film to contain the soft material, then the gel can be contained, but adhesion between the gel and film is poor
Solution Approach 1:
The invention uses a composite material approach by combining silicone gel with silicone elastomer. Both materials are silicon-based and share similar chemical properties, which improves adhesion between the materials. The elastomer acts as both structural support and adhesive layer, eliminating the need for separate film encapsulation while maintaining containment reliability.
3Ease of operation
If attachable prostheses with silicone adhesive gel are used to eliminate the need for pocketed bras, then ease of wear is improved, but maintenance and cleaning become more complex
Solution Approach 1:
The firm silicone elastomer back provides durable, long-lasting adhesion that eliminates the need for replaceable adhesive layers. Unlike attachable prostheses that require periodic replacement of adhesive gel, this integrated elastomer structure maintains its bonding capability throughout the product lifecycle, reducing maintenance complexity.
4Stability of the object's composition
If 100% silicone elastomer is used to eliminate the need for pocketed bras, then position stability is improved, but the prosthesis does not mimic fatty tissue feel and movement
Solution Approach 1:
The breast prosthesis is divided into two distinct parts: a soft silicone gel part (mimicking fatty tissue) and a firm silicone elastomer part (提供稳定支撑). This segmentation allows each part to fulfill its specific function - the gel provides comfort while the elastomer provides stability, resolving the contradiction between comfort and position stability.
5Adaptability or versatility
If existing multi-part prostheses combining elastomers and gels are used, then both materials' benefits can be achieved, but the design becomes cumbersome
Solution Approach 1:
The invention merges the elastomer and gel parts into a single integrated prosthesis unit. The firm silicone elastomer and soft silicone gel are bonded together to form one cohesive structure that can be worn as a single piece, eliminating the need for separate components and fasteners while maintaining the benefits of both materials.
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 combined prosthesis provides improved comfort, secure fit, and durability by mimicking fatty tissue feel and movement, reducing skin irritation and maintenance, while allowing versatile bra placement options.
Implementation Method 1
using a two-chamber bag process with polytetrafluoroethylene, polyurethane layers, and a heat-sealing method to ensure adhesion and durability
Data Source
AI summary
A breast prosthesis includes a front part that is made of a silicone gel that is encapsulated in a polymer film. A back part that is made from a silicone elastomer is affixed thereto. An alternate form of breast prosthesis includes a front part that is made from a silicone elastomer. A back part that is made of a silicone gel that is encapsulated in a polymer film and that is affixed thereto. In a method of making a breast prosthesis in which a two chamber bag that includes a layer of polytetrafluoroethylene (“PTFE”), a layer of polyurethane and a layer of polyurethane is made. The bag is placed into a mold that defines a breast form-shaped cavity. A silicone gel material is injected into one chamber and a silicone elastomer material is injected into the other chamber. The materials are cured and the PTFE layer is removed.