Biomedical Device Encapsulation with Inorganic Barrier Layers
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Solution Overview
Problem
Biomedical devices with powered components and power sources face challenges in protecting these components from bodily fluids and ensuring user safety, as contact with fluids can short out the power source or harm the user, while existing solutions fail to provide long-term protection and compatibility with human tissues.
Innovation Solution
A protective encapsulation structure for biomedical devices, including multiple layers such as inorganic barrier layers and molded polymer layers, with conformal coatings to prevent moisture and chemical exposure, ensuring the device's functionality and biocompatibility, applied to devices like contact lenses and pacemakers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If powered functional components and power sources are introduced into medical devices, then device functionality is improved, but protection from bodily fluids and user safety become compromised
Solution Approach 1:
The encapsulation is divided into multiple distinct layers including an inner conformal coating layer, an intermediate barrier layer, and an outer conformal coating layer. Each layer serves specific protective functions, creating a segmented defense system that addresses multiple protection requirements simultaneously while maintaining device functionality.
Solution Approach 2:
The encapsulation employs composite material structure combining different materials with complementary properties - the inner conformal coating provides adhesion and initial protection, the intermediate barrier layer provides moisture and fluid resistance, and the outer conformal coating provides additional environmental protection. This composite approach resolves the contradiction by integrating multiple protective functions in a unified encapsulation system.
2Adaptability or versatility
If powered functional components and power sources are introduced into medical devices, then device functionality is improved, but user safety from exposure to components is compromised
Solution Approach 1:
The encapsulation structure implements a nested doll approach where the inner conformal coating layer is nested within the intermediate barrier layer, which is in turn nested within the outer conformal coating layer. This nested configuration creates multiple containment barriers that prevent harmful factors from reaching the user while preserving the functional components inside, directly addressing the safety concern.
Solution Approach 2:
The encapsulation utilizes thin film structures that conform to the shape of the functional components while providing comprehensive protection. These flexible thin film layers create a continuous protective shell around the powered components, isolating them from bodily fluids and preventing user exposure without compromising device functionality.
3Reliability
If contact with bodily fluids is prevented, then device functionality is maintained, but device complexity increases
Solution Approach 1:
The encapsulation structure is designed with multi-functionality where each layer serves multiple purposes - the conformal coating layers provide both adhesion and environmental protection, while the intermediate barrier layer provides both moisture resistance and structural support. This universal design approach maintains device functionality through comprehensive protection while minimizing overall complexity by having each component perform multiple functions.
Solution Approach 2:
The encapsulation applies local quality by concentrating protective properties where they are most needed - the intermediate barrier layer is positioned specifically between the functional components and the external environment to provide the critical moisture and fluid barrier, while the conformal coating layers provide localized adhesion and protection at the component surfaces. This targeted approach maintains functionality with minimized structural complexity.
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 encapsulation effectively shields electronic components and power sources from bodily fluids and sterilization processes, maintaining device functionality for extended periods and ensuring user safety by providing a chemical, electrical, and moisture-resistant barrier.
Implementation Method 1
one or more barrier layers comprising an inorganic material surrounding the energy source, electro-active device and integrated circuitry
Implementation Method 2
one or more first conformal coatings between the barrier layer(s) and the energy source, electro-active device and integrated circuitry
Data Source
AI summary
A biomedical device including an energy source, an electro-active device operatively connected to the energy source, circuitry configured to control operation of the electro-active device, at least one barrier layer including at least one inorganic material surrounding the energy source, electro-active device and circuitry, and at least one molded layer surrounding the at least one barrier layer. A method for encapsulating electronic components of an electro-active biomedical device in a protective envelope containing a barrier layer including at least one inorganic compound, and a molded polymer overcoat.