Porous Elastomer Coating Anchoring Gastrointestinal Implants
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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 current textured surface methods do not fully prevent these complications, especially in gastrointestinal tract implantations where invasive anchoring methods can cause adverse effects.
Innovation Solution
A porous material comprising a non-resorbable, biocompatible elastomer matrix with interconnected pores is used to anchor implant devices within the gastrointestinal tract, allowing tissue ingrowth for secure fixation without inducing significant fibrous capsule formation, utilizing a porogen composition with a shell and core material to control fusion and achieve uniform pore structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a smooth surface implant is used, then the device is easy to manufacture, but it induces fibrous capsule formation and capsular contracture
Solution Approach 1:
The patent applies porous materials by creating a porous coating on the implant surface that allows tissue ingrowth. The porous structure is formed using porogens (sacrificial particles) that are embedded in the coating material and then removed, leaving interconnected pores that facilitate tissue integration and prevent fibrous capsule formation while maintaining ease of manufacture through spray coating processes
Solution Approach 2:
The patent uses composite materials by combining the coating material (e.g., polyether block amide, polyurethane) with porogens (sacrificial particles of glass beads, metal oxides, or ceramic materials). This composite structure allows the coating to provide mechanical adhesion while the porogens create the porous architecture needed to prevent capsular contracture
2Object-affected harmful factors
If a textured surface is imprinted on the implant, then capsular formation is reduced, but capsular contracture can still occur and the manufacturing process becomes more complex
Solution Approach 1:
The patent creates a porous surface structure that is more effective than simple texturing. The porous coating with interconnected pores (50-200 micrometers) allows deeper tissue ingrowth compared to surface texturing, providing better prevention of capsular contracture while using a spray coating process that is simpler than imprinting textured surfaces
Solution Approach 2:
The patent uses porogens as intermediaries to create the porous structure. The porogens (sacrificial particles) are temporarily embedded in the coating material during application, then removed to leave the desired porous architecture. This intermediary approach simplifies manufacturing compared to direct texturing methods
3Strength
If invasive anchoring methods (sutures or barbs) are used in gastrointestinal tract implantation, then the device is securely anchored, but adverse effects occur in the patient's body
Solution Approach 1:
The patent applies self-service by designing the implant surface to automatically anchor itself through tissue ingrowth into the porous structure. The porous coating provides mechanical interlocking as tissue grows into the pores, eliminating the need for invasive sutures or barbs and avoiding the adverse effects associated with those methods
Solution Approach 2:
The porous surface structure enables tissue ingrowth that provides secure anchoring without invasive methods. The interconnected pores (50-200 micrometers) allow tissue to penetrate and mechanically lock the implant in place, providing strong anchoring strength while avoiding the harmful effects of sutures or barbs in the gastrointestinal tract
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 fibrous capsule formation and contracture, providing a secure and less invasive anchoring method for implantable devices within the gastrointestinal tract, improving both aesthetic and functional outcomes by promoting tissue integration without adverse reactions.
Implementation Method 1
utilizing a porogen composition with a shell and core material to control fusion and achieve uniform pore structures
Implementation Method 2
the array of interconnected pores contacts the mucosal lining and receives tissue ingrowth from the mucosal lining to anchor the implant device to the mucosal lining
Data Source
AI summary
The present specification discloses porous materials, methods of forming such porous material, biocompatible implantable devices comprising such porous materials, and methods of making such biocompatible implantable devices. The porous material may be used to fix to the interior mucosal lining of a patient's gastrointestinal tract.