Hermetically Sealed PCB Encapsulation for Surgical Devices
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Solution Overview
Problem
Reusable surgical devices with electronic components face durability issues due to moisture ingress and damage from high-pH cleaning and sterilization processes, leading to corrosion and degradation of electronic components.
Innovation Solution
The integration of electronic components into a hermetically sealed or encapsulated chamber within a printed circuit board, using methods such as bonding a cap to the substrate and sealing it to form a leak-proof barrier, and applying encapsulation materials to protect against environmental stresses during assembly and repeated cleaning cycles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If electronic components are exposed to high-pH cleaning and sterilization processes, then surgical devices can be reused, but the electronic components suffer from moisture ingress and corrosion leading to degradation
Solution Approach 1:
The device is divided into separate functional modules: a disposable surgical instrument portion and a reusable powered portion containing electronic components. This segmentation allows the electronic components to be protected from direct exposure to harsh cleaning and sterilization environments while still enabling device reuse.
Solution Approach 2:
A hermetically sealed enclosure acts as an intermediary barrier between the electronic components and the harsh external environment during cleaning and sterilization. The enclosure includes moisture barriers and sealing mechanisms that prevent moisture ingress while allowing the device to undergo repeated cleaning cycles.
2Reliability
If conformal coatings and sealed enclosures are used to protect electronic components, then durability is improved, but cracking or delamination of coatings and heat damage during sealing can still occur
Solution Approach 1:
Multiple protective layers are applied to the electronic components including conformal coatings, potting compounds, and hermetic sealants. These composite protective structures provide redundant barriers against moisture and thermal stress, preventing coating failure and heat damage during the sealing process.
Solution Approach 2:
The electronic components are pre-protected with conformal coatings and moisture barriers before the sealing process. This beforehand protection cushions the components against thermal stress and prevents coating delamination during subsequent hermetic sealing and cleaning operations.
3Reliability
If disposable surgical devices are used, then reliability is maintained, but product cost increases compared to reusable units
Solution Approach 1:
The surgical device is segmented into disposable and reusable portions. The disposable portion (surgical instrument) is discarded after single use to maintain surgical sterility and reliability, while the reusable portion (powered device with electronic components) can be cleaned and sterilized multiple times, reducing overall product cost.
Solution Approach 2:
The disposable surgical instrument portion is discarded after use, while the valuable powered portion containing electronic components is recovered, cleaned, and reused. This approach maintains reliability by discarding the portion that contacts the patient while recovering the expensive electronic components for repeated use.
Data Source
AI summary
A method of encapsulating and hermetically sealing a printed circuit board of a flex cable includes: positioning a printed circuit board portion of a flex cable into a channel defined in a first mold half of a mold, the printed circuit board portion including a substrate and electronic components mounted on the substrate; mounting a second mold half onto the first mold half to enclose the channel of the first mold half and form a cavity within the mold; and filling the cavity of the mold with an encapsulation material through an inlet opening defined through the mold.