Porous Elastomer Coating for Implantable Devices
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Solution Overview
Problem
Implantable medical devices often induce a foreign body response leading to fibrous capsule formation and capsular contracture, which can cause aesthetic and painful issues, and existing textured surfaces do not adequately prevent these complications.
Innovation Solution
A porous material with a substantially non-degradable, biocompatible elastomer matrix featuring an array of interconnected pores is created through a method involving fusing porogens, coating with an elastomer, curing, and removing the porogen scaffold, which promotes cellular ingrowth and reduces fibrous capsule formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a smooth surface is used for implantable medical devices, then manufacturing is simple, but fibrous capsule formation and capsular contracture occur
Solution Approach 1:
The patent applies porous materials by creating a porous coating layer on the implantable device surface. This porous structure allows cellular ingrowth into the material, promoting tissue integration and preventing fibrous capsule formation. The pores are formed through a phase separation process where a porogen is mixed with polymer, cured, and then the porogen is extracted, leaving a controlled porous architecture that facilitates biological integration while maintaining manufacturing feasibility.
Solution Approach 2:
The patent uses composite materials by combining polymer matrices with porogen phases to create a composite coating structure. The composite consists of a polymer network (e.g., polyurethane, polyester, or silicone-based polymers) integrated with a porogen phase that, when removed, creates the porous architecture. This composite approach enables control over pore size, distribution, and connectivity while maintaining the mechanical properties needed for implantable devices.
2Object-affected harmful factors
If a textured surface is imprinted onto the implant, then capsular formation is reduced, but the surface architecture is limited to hills and valleys
Solution Approach 1:
The patent transitions from surface-level texturing to volumetric porosity by creating a porous coating layer with interconnected pores extending through the coating thickness. This three-dimensional porous architecture allows cellular ingrowth throughout the coating volume, not just at the surface, providing enhanced tissue integration and more effective prevention of capsular formation compared to traditional surface texturing.
Solution Approach 2:
The patent adds a third dimension to surface architecture by creating pores that extend through the coating thickness rather than仅限于 surface features. This dimensional transition from 2D surface texturing to 3D volumetric porosity enables cellular ingrowth into the material bulk, providing more effective tissue integration and preventing capsular contracture through enhanced biological interaction.
3Shape
If porous material is created through phase separation and porogen extraction, then interconnected pore network is formed, but manufacturing process complexity increases
Solution Approach 1:
The patent applies preliminary action by pre-forming the porous structure within the coating material before implantation. The porogen is mixed with the polymer and cured to create the porous architecture in advance, and then the porogen is extracted to leave the desired pore network. This preliminary formation of the porous structure eliminates the need for complex post-implantation processing or sophisticated real-time manufacturing techniques.
Solution Approach 2:
The patent uses an intermediary substance (porogen) to create the porous structure. The porogen acts as a temporary phase that is mixed with the polymer, cured, and then extracted to leave the desired pore network. This intermediary approach simplifies the manufacturing process compared to direct pore formation methods, as the porogen provides a straightforward mechanism for creating interconnected pores through phase separation and extraction.
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 porous material effectively reduces or prevents fibrous capsule formation and capsular contracture, enhancing the integration of implantable devices while maintaining mechanical strength and preventing scarring.
Implementation Method 1
coating the porogen scaffold with an elastomer base to form an elastomer coated porogen scaffold
Implementation Method 2
curing the elastomer coated porogen scaffold
Implementation Method 3
removing the porogen scaffold, wherein porogen scaffold removal results in a porous material
Data Source
Figure 1A
Figure 1B
Figure 2A~2D
AI summary
The present specification discloses porous materials, methods of forming such porous materials, biocompatible implantable devices comprising such porous materials, and methods of making such biocompatible implantable devices.