Soft Tissue Implant Wells for Stability Without Biofilm
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Solution Overview
Problem
Textured breast implants provide stability but are associated with Breast Implant Associated-Acute Large Cell Lymphoma (BIA-ALCL) due to bacterial biofilm formation on their rough surfaces, necessitating a solution that maintains stability without promoting biofilm growth.
Innovation Solution
A breast implant with a smooth surface and position-stabilizing wells that allow tissue ingrowth to stabilize the implant, discouraging bacterial biofilm formation and reducing the risk of BIA-ALCL.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If textured implant surface is used, then implant stability and resistance to rotation are improved, but bacterial biofilm formation is promoted leading to BIA-ALCL
Solution Approach 1:
The implant surface is segmented into two distinct zones: a smooth outer surface that contacts the capsule and resists biofilm formation, and position-stabilizing wells that extend inward to provide mechanical stability. This segmentation allows each zone to perform its specific function without compromising the other.
Solution Approach 2:
Different regions of the implant surface are given different properties: the outer surface is smooth to prevent biofilm, while the inner wells provide roughness and tissue ingrowth capability for stability. This local differentiation resolves the contradiction between smoothness and stability.
2Object-affected harmful factors
If smooth implant surface is used, then bacterial biofilm formation is reduced, but implant stability and resistance to rotation deteriorate
Solution Approach 1:
The solution moves from a two-dimensional surface texture problem to a three-dimensional structure by adding wells that extend inward from the surface. This dimensional transition allows stability to be achieved through depth rather than surface roughness, keeping the outer surface smooth.
3Reliability
If textured implant surface is used, then capsular contracture and implant malposition are decreased, but BIA-ALCL risk increases
Solution Approach 1:
The implant surface is segmented into a smooth outer zone for capsular interaction and inner wells for stability, allowing capsular contracture prevention without the BIA-ALCL risk associated with fully textured surfaces.
Data Source
AI summary
An implant including a shell and a plurality of position-stabilizing wells is described. The position-stabilizing wells are defined by an opening at least one-half (0.5) millimeters across. The position-stabilizing wells allow the ingrowth of tissue so as to stabilize the shaped in implant after implantation in a patient. Additionally, the shaped implant has a smooth surface so as to discourage the formation of a bacterial biofilm. The disclosed implant can further be attached to an underlying tissue in the patient by position-stabilizing tabs.


