Passive Vent Valve for Brachytherapy Balloon Catheters
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Solution Overview
Problem
Conventional medical valves used in brachytherapy devices are difficult to sterilize effectively, as they are either contaminated during capping and uncapping or experience undesired expansion during vacuum sterilization, leading to non-sterile products.
Innovation Solution
A passive vent valve assembly with a diametrically vented region and a threaded external luer, featuring a cap that can exist in packaging and use configurations, allowing for sterilization of all surface areas while maintaining a sealed system during use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the valve is kept closed during sterilization, then the sealed system is maintained, but the sterilizing agent cannot reach all surfaces of the device
Solution Approach 1:
The valve body is segmented into multiple functional regions: a sealed port system for clinical use, and a vented region with multiple access points for sterilization. The cap can be removed or opened during sterilization to allow the sterilizing agent to penetrate all surfaces, then replaced to restore the sealed configuration for patient use.
Solution Approach 2:
The valve is designed with pre-configured vent channels and access points that are sealed during normal operation but can be easily opened before sterilization. This preliminary design allows the sterilizing agent to reach all internal surfaces without requiring disassembly of the entire device, and the sealed configuration is restored after sterilization completes.
2Reliability
If vacuum is applied during sterilization, then the sterilizing agent reaches all surfaces, but the connected volume expands and may rupture
Solution Approach 1:
A passive vent valve assembly acts as an intermediary component between the sealed port system and the external environment. This assembly includes pressure-equalization channels that allow atmospheric pressure to balance against vacuum pressure during sterilization, preventing the connected volume from expanding while still permitting sterilizing agent circulation through the vented region.
Solution Approach 2:
The vent valve assembly incorporates porous or permeable materials in strategic locations that allow gas permeation during sterilization but maintain structural integrity. These materials enable pressure equalization and sterilizing agent passage without compromising the strength of the connected volume or allowing uncontrolled expansion under vacuum conditions.
3Reliability
If the valve is opened for sterilization access, then all surfaces can be sterilized, but contamination risk increases during handling
Solution Approach 1:
The cap is designed as a separate, removable component that can be taken off during sterilization to allow access to all surfaces. The cap itself can be sterilized separately or autoclaved, and its removal is a brief, controlled operation that minimizes exposure time. After sterilization, the cap is replaced to immediately restore the sealed, contamination-resistant configuration for clinical use.
Data Source
AI summary
Embodiments of passive vent valve devices are disclosed. One of the novel aspects of the invention is its ability to transform from a packaging configuration to a use configuration. The packaging configuration allows sterilization gases to penetrate into the device through standard valve openings as well as through vented mesh openings. Passage of gas into the device, in turn, provides a means of sterilizing all surface areas in the device. Alternatively, when the valve is placed in a use configuration, the passage of gas through the vented mesh is inhibited providing a sealed environment that functions as a valve. The invention is useful in manufacturing sterile medical devices by allowing all surfaces to communicate with the sterilizing agent when the valve is in a packaging configuration or when it is in a use configuration.