Soft Prosthesis Shell Texturing with Rounded Salt Crystals
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Solution Overview
Problem
Existing soft prosthetic implants face challenges in preventing capsular contracture, which can lead to spherical, painful, and aesthetically undesirable outcomes due to the degradation of foam materials used for texturing their surfaces.
Innovation Solution
A process involving the formation of a flexible silicone elastomer shell with a textured surface by adhering rounded particles, such as sodium chloride crystals, and then dissolving them to create an open-pored structure, which enhances the mechanical properties of the implant.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If foam materials (polyether, polyester or polyurethane) are applied to the back sides of mammary prostheses to prevent capsular contracture, then the prosthesis is anchored securely to the chest wall, but the materials may degrade in the body over time causing the effectiveness to disappear
Solution Approach 1:
The patent applies a porous coating to the outer surface of the implant shell, creating a textured surface with open pores that allow fibrous tissue ingrowth. This porous structure provides mechanical anchoring to prevent capsular contracture while being integrated into the silicone elastomer matrix, which does not degrade like foam materials. The porous layer is formed by applying a coating and then removing portions of it to create the textured surface.
2Shape
If conventional angular salt crystals are used for texturing the implant surface, then the surface texture is created, but stress concentrations occur reducing the mechanical properties
Solution Approach 1:
The patent specifically uses rounded salt crystals instead of angular ones to create the surface texture. The rounded shape of the crystals eliminates sharp corners and edges that would create stress concentrations in the silicone elastomer shell. This spherical curvature of the particulate material maintains the desired surface texture while preserving the mechanical strength and elasticity of the implant.
3Reliability
If a textured surface is applied to prevent capsular contracture, then fibrous tissue can grow into the material, but the complexity of the manufacturing process increases
Solution Approach 1:
The patent incorporates the texturing step into the shell manufacturing process itself, before the implant is sterilized and packaged. The porous coating is applied to the uncured shell, the salt crystals are applied and embedded, and then the shell is cured with the crystals still in place. This preliminary integration of texturing into the base manufacturing process avoids adding separate complex steps after shell formation.
Solution Approach 2:
The salt crystals serve as an intermediary material that facilitates the creation of the porous texture. The crystals are applied to the uncured shell, embedded into the material, and then the shell is cured around them. The crystals are subsequently removed, leaving behind the desired porous structure. This intermediary approach simplifies the process compared to directly creating pores or using complex coating techniques.
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 process results in implants with superior ultimate break force, ultimate elongation, and ultimate tensile strength compared to those using conventional angular salt crystals, reducing stress concentrations and meeting or exceeding regulatory standards for elongation.
Implementation Method 1
causing or allowing the rounded particles to be removed from the shell thereby leaving impressions of the particles in the shell to create an open-pored structure on a surface thereof
Data Source
AI summary
A method of texturing a soft prosthetic implant shell, such as a silicone breast implant shell. A soft prosthetic implant with a textured external surface layer of silicone elastomer and having an open-cell structure is made by adhering and then dissolving round salt crystals. The resulting roughened surface has enhanced physical properties relative to surfaces formed with angular salt crystals. An implant having such a textured external surface layer is expected to help prevent capsular contraction, to help prevent scar formation, and to help in anchoring the implant within the body.