Exposure Valve Sealing for Sterilizing Sealed Drug Delivery Components
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Solution Overview
Problem
Conventional fluid delivery devices with sealed components pose a challenge for efficient sterilization as they cannot be manually disassembled or exposed to sterilization conditions due to their sealed design, conflicting with system design advantages.
Innovation Solution
Incorporation of a shape-memory alloy (SMA) wire that activates at elevated sterilization temperatures to unseal sealed regions, allowing exposure to sterilization sources and then re-seals after sterilization, ensuring hermetic sealing during device operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sealed components are designed to be hermetically sealed during operation, then device reliability and protection from contamination is improved, but sterilization becomes difficult or impossible without manual disassembly
Solution Approach 1:
The seal is designed to dynamically change state between sealed and open configurations. The shape memory alloy wire provides a temporary opening during sterilization, then automatically returns to the sealed state, making the sealing property dynamic rather than static.
Solution Approach 2:
The seal's physical state is changed temporarily by applying thermal energy from the sterilization process. The shape memory alloy wire responds to temperature parameter changes by expanding or contracting to open the seal, allowing sterilization access, then returns to original state when temperature normalizes.
2Productivity
If the device is fully assembled before sterilization, then manufacturing efficiency is improved, but sealed regions cannot be exposed to sterilization sources
Solution Approach 1:
The shape memory alloy wire is pre-positioned within the sealed component during assembly. This preliminary placement enables the wire to function as an embedded mechanism that can be activated later during sterilization without requiring disassembly of the assembled device.
Solution Approach 2:
The shape memory alloy wire acts as an intermediary element between the sealed component and the sterilization process. It mediates by temporarily creating an opening that allows sterilization sources to penetrate sealed regions, then restores the seal after sterilization completes.
3Object-affected harmful factors
If manual disassembly is used to expose sealed components, then sterilization access is improved, but device complexity and risk of contamination increase
Solution Approach 1:
The sealed component performs self-service by using its own structural elements (the shape memory alloy wire) to create the opening needed for sterilization. The component activates its own seal-opening mechanism through the thermal energy of the sterilization process itself, eliminating the need for external manual intervention.
Solution Approach 2:
The manual mechanical disassembly process is replaced by a thermal-mechanical system. Instead of physically opening the seal with tools or hands, the sterilization heat activates the shape memory alloy wire to automatically open the seal, substituting a thermal field for mechanical manipulation.
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
Facilitates efficient sterilization of sealed components by temporarily opening them during specified conditions and permanently re-sealing, maintaining device integrity and functionality.
Implementation Method 1
Incorporation of a shape-memory alloy (SMA) wire that activates at elevated sterilization temperatures to unseal sealed regions
Implementation Method 2
then re-seals after sterilization, ensuring hermetic sealing during device operation
Data Source
AI summary
Fluid delivery devices with sterilization management systems are described. For example, a fluid delivery device may include a device region fluidically coupled to a fluid path, the fluid path having at least one opening to allow a sterilization source to flow into the device region, an exposure valve arranged in the fluid path and configured to seal or unseal the at least one opening, the exposure valve comprising a piston having a sealing component arranged at a first end facing the at least one opening, a biasing element configured to contact a second end of the piston, arranged opposite the first end, to bias the piston toward the at least one opening, an activation element configured to be activated by a stimulus to move the piston to a sterilization position during a sterilization process and deactivated responsive to removal of the stimulus to cause the piston to be moved into a sealing position, the at least one opening is unsealed when the piston is in the sterilization position to allow a sterilization source to sterilize the device region via the fluid path. Other embodiments are described.