Sealed Drug Delivery Components With Heat-Activated Sterilization Access
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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 an activation component, such as a shape-memory alloy (SMA) wire, that unseals sealed regions during sterilization by responding to elevated temperatures, allowing exposure to sterilization sources and then re-seals the regions post-sterilization, ensuring a hermetic seal during device operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sealed components are designed to be hermetic during operation, then reliability is improved, but sterilization efficiency deteriorates because manual disassembly is not practical
Solution Approach 1:
The system performs preliminary action by automatically opening sealed components before sterilization and automatically sealing them after sterilization. The controller activates motors to open valves or ports before the sterilization chamber is pressurized, allowing sterilization media to contact internal surfaces. After sterilization, the controller automatically closes the components to restore hermetic seals, eliminating the need for manual disassembly while ensuring complete sterilization.
Solution Approach 2:
The system implements self-service through automated control mechanisms that perform opening and sealing operations without human intervention. Sensors detect when sterilization is complete and automatically trigger the sealing mechanism, which uses motors and control circuits to restore the hermetic state. This self-service capability resolves the contradiction by making the system both sterilizable and reliably sealed through automation.
2Productivity
If sealed components are opened for sterilization, then sterilization efficiency is improved, but device complexity increases due to additional sealing mechanisms
Solution Approach 1:
The system applies multi-functionality by using the same motorized actuators and control circuits for both opening components during sterilization and closing them afterward. The sealing mechanisms serve dual purposes: enabling sterilization access and restoring hermetic seals. This universal approach reduces overall device complexity compared to having separate dedicated mechanisms for each function.
Solution Approach 2:
The system merges the opening and sealing operations into a single automated control sequence managed by one controller. The same physical components (motors, valves, seals) perform both functions at different times, rather than requiring separate independent systems. This merging reduces the number of separate mechanisms needed, thereby reducing device complexity while maintaining sterilization capability.
3Reliability
If manual disassembly is used to expose sealed components, then sterilization completeness is improved, but ease of operation deteriorates
Solution Approach 1:
The system replaces manual mechanical disassembly with an automated motorized system. Instead of requiring operators to physically open sealed components, the controller activates motors that automatically open valves or ports, expose internal surfaces to sterilization media, and then automatically close and seal the components. This substitution maintains complete sterilization while dramatically improving ease of operation by eliminating manual intervention.
Solution Approach 2:
The system performs the opening and sealing operations autonomously without human assistance. Sensors monitor the sterilization process and automatically trigger the motorized opening/closing sequence when appropriate. This self-service capability ensures complete sterilization exposure while making the process as easy to operate as simply initiating the sterilization cycle, resolving the contradiction between completeness and ease of operation.
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
Enables efficient sterilization of sealed components within fluid delivery devices by temporarily exposing them to sterilization conditions while maintaining a permanent seal, aligning system design advantages with sterilization efficiency.
Implementation Method 1
Incorporation of an activation component, such as a shape-memory alloy (SMA) wire, that unseals sealed regions during sterilization by responding to elevated temperatures
Implementation Method 2
allowing exposure to sterilization sources and then re-seals the regions post-sterilization, ensuring a hermetic seal 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.