Soft Prosthesis Shell with Discrete Fixation Surfaces
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Solution Overview
Problem
Existing soft prosthetic implants, such as breast implants, face challenges in texturing their outer surfaces to enhance adhesion and prevent capsular contracture while maintaining the benefits of smooth implants.
Innovation Solution
The development of a soft prosthetic implant shell with discrete fixation surfaces featuring open cell textures that align with muscle groups, allowing for controlled tissue ingrowth and adhesion, and varying textures to disrupt capsular tissue formation, manufactured using a process involving a silicone elastomer shell with different configurations of solid particles applied before curing and dissolved to create distinct open cell structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the implant shell surface is made smooth, then the implantation process is easier and the shell is less prone to wear, but tissue adhesion is reduced and capsular contracture risk increases
Solution Approach 1:
The implant shell incorporates discrete fixation surfaces with open cell textures at specific locations (such as the posterior surface) while maintaining smooth surfaces in other areas. This local texturing provides enhanced tissue adhesion and capsular contracture resistance at critical interfaces without compromising the overall ease of implantation or creating excessive wear points across the entire shell surface.
2Reliability
If the implant shell surface is textured to enhance tissue adhesion, then capsular contracture is reduced, but the implant moves less naturally with the body and experiences increased wear from material stresses
Solution Approach 1:
By concentrating the textured fixation surfaces to discrete locations rather than covering the entire shell, the patent achieves adequate tissue adhesion and capsular contracture resistance at the implant-tissue interface while preserving larger smooth surface areas that experience reduced stress concentrations and wear during body movement.
Solution Approach 2:
The shell surface is segmented into distinct functional zones: textured fixation surfaces for tissue adhesion and smooth surfaces for reduced wear. This segmentation allows each zone to perform its optimal function without compromising the other, balancing capsular contracture resistance with durability.
3Reliability
If discrete fixation surfaces with open cell textures are added to the shell, then tissue ingrowth is enhanced and movement with the body is improved, but the manufacturing process becomes more complex
Solution Approach 1:
The fixation surfaces utilize open cell porous textures that facilitate tissue ingrowth and adhesion. These porous structures are created through controlled manufacturing processes (such as particle embedding and dissolution) that, while adding a step to the process, enable reliable tissue integration and natural movement with the body.
Solution Approach 2:
The manufacturing process incorporates preliminary actions such as embedding particles in the uncured elastomer layer before curing, which simplifies the overall process by combining texturing with the shell formation step itself, rather than requiring separate post-processing texturing operations.
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 textured surfaces enhance natural movement with the body, reduce wear from material stresses, and minimize capsular contracture, providing a more secure and aesthetically desirable implantation experience.
Implementation Method 1
the solid particles are then dissolved, for example, by means of a solvent that does not dissolve the silicone elastomer to any appreciable extent
Data Source
Figure 1A~2B
Figure 3A~3B
Figure 4A~4B
AI summary
A soft prosthetic implant shell, such as a silicone breast implant shell, that has discrete fixation surfaces thereon for tissue adhesion. The fixation surfaces may be provided on the posterior face of the shell, as well as either on the periphery or at discrete areas on the anterior face. Band-shaped fixation surfaces may be provided on the anterior face of the shell to generally match the angle of pectoralis major or pectoralis minor muscle groups. The fixation surfaces may be roughened areas of the shell, or may be separate elements adhered to the shell.