Soft Prosthetic Implant Macro-Texturisation for Easier Removal
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Solution Overview
Problem
Existing textured implants are linked to anaplastic large cell lymphoma (ALCL) and capsular contraction, and existing solutions do not adequately address these issues while ensuring easy implant removal and tissue compatibility.
Innovation Solution
Implants with macro-texturisation regions of 0.3 - 1.5 cm depth, provided by a partially resorbable scaffold of silicone polymer and polymers like polylactic acid or polyglycolic acid, which reduce or eliminate micro-texturisation, promoting tissue growth and preventing rotation/migration, and are easier to remove.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the implant surface is completely texturised (micro-texturisation), then capsular contraction is reduced and implant retention is improved, but the risk of ALCL increases and removal becomes more difficult
Solution Approach 1:
The implant surface is segmented into two distinct zones: a smooth zone that provides a barrier to ALCL and an atrophic zone with macro-texturisation (0.3-1.5cm depth) that promotes capsular contraction reduction. 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 qualities: the smooth zone has a completely smooth surface to prevent ALCL, while the atrophic zone has macro-texturisation to reduce capsular contraction. This local differentiation resolves the contradiction by applying appropriate surface characteristics to appropriate locations.
2Reliability
If the implant surface is completely texturised (micro-texturisation), then implant retention is improved, but ease of removal deteriorates
Solution Approach 1:
The implant surface is divided into a smooth zone for easy removal and an atrophic zone for retention during healing. The smooth zone allows for straightforward extraction when removal is needed, while the atrophic zone maintains retention during the critical healing period.
Solution Approach 2:
The smooth zone is specifically designed with a completely smooth surface to facilitate easy removal, while the atrophic zone provides retention. This local quality differentiation ensures that removal ease is not compromised by retention requirements.
3Reliability
If macro-texturisation is applied to the implant surface, then capsular contraction is reduced and ALCL risk is lowered, but manufacturing complexity increases
Solution Approach 1:
The manufacturing process is segmented into separate operations: creating the smooth zone and creating the atrophic zone with macro-texturisation. This can be achieved through techniques like selective laser sintering or 3D printing with different material densities, allowing each zone to be formed independently rather than requiring complex single-step processes.
Solution Approach 2:
The implant incorporates a composite structure combining smooth polymer material in the smooth zone and atrophic polymer material in the atrophic zone. This composite approach allows each region to be manufactured separately and then assembled, reducing overall manufacturing complexity while achieving the desired functional differentiation.
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 macro-texturisation reduces ALCL risk, minimizes capsular contraction, and allows for easier implant removal with less tissue damage, while ensuring tissue compatibility and growth.
Implementation Method 1
The implant body comprises one or more regions of macro-texturisation on a surface of the implant body, wherein the region of macro-texturisation is of depth in the range of 0.3 - 1.5 cm
Implementation Method 2
the region of macro-texturisation acts to encourage new soft-tissue growth and prevent implant rotation, flipping or migration
Implementation Method 3
the scaffold is partially resorbable and comprises a silicone polymer and a polymer selected from polylactic acid, polyglycolic acid, polycaprolactone, polytrimethylene carbonate, polyhydroxybuterate, polyhydroxyvalerate or combinations thereof
Data Source
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AI summary
An implant comprising an implant body, wherein the implant body comprises one or more regions of macro-texturisation on a surface of the implant body. Various methods of making an implant comprising one or more regions of macro-texturisation on a surface of the implant body are described, the methods being (i) making an implant comprising forming a shell on a mandrel, wherein the mandrel is shaped to form regions of macro-texturisation in the shell and filling the shell with a core material; (ii) making an implant comprising securing a scaffold comprising a silicone polymer to a surface of an implant body or (iii) making an implant comprising extruding a material that will form regions of macro-texturisation onto an implant body or (iv) making an implant comprising laser etching a surface on an implant body to form regions of macro-texturisation.