Reusable Hub Spike Adapter for Medical Fluid Containers
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Solution Overview
Problem
The current multi-patient practice for injecting iodinated contrast agents in CT scans faces contamination risks due to the large spike needle's exposure to ambient air, leading to potential contamination of the contrast agent, especially when switching between bottles and inadequate disinfection.
Innovation Solution
A medical container assembly with a spike assembly that includes a container perforator with air and liquid passages, a spike interface cover that detaches and reuses with multiple spike assemblies, and features like retention members and a frusto-conical exterior section to reduce installation force and prevent reuse, minimizing contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a large diameter spike needle is used to perforate different types of septums, then the spike can penetrate various bottle seals effectively, but the exposed surface area of the spike needle increases, leading to higher contamination risk
Solution Approach 1:
The device is divided into a reusable hub assembly and a disposable spike assembly. The spike assembly includes the container perforator and is discarded after single use, while the hub assembly with air and liquid passages is retained for multiple uses. This segmentation isolates the contamination-prone spike component into a disposable unit.
Solution Approach 2:
The spike assembly is designed as a disposable component that is discarded after a single use with one primary container. This eliminates the risk of cross-contamination between patients by ensuring the spike never contacts ambient air or contaminated surfaces, while the more expensive hub assembly with passages is protected for reuse.
2Productivity
If the spike needle is left exposed to air between bottle changes, then it can be quickly repositioned for the next container, but it becomes contaminated by ambient air and surfaces
Solution Approach 1:
The spike assembly is designed for single-use only and is discarded after one container is accessed. This eliminates the need to reposition or reuse the spike between patients, ensuring it never contacts contaminated surfaces or ambient air, while maintaining efficient workflow during the single use period.
Solution Approach 2:
The spike assembly is extracted as a separate disposable component from the reusable hub assembly. This allows the spike to be pre-packaged in sterile condition and discarded after use, while the hub assembly with air and liquid passages remains in the system for continuous use with multiple spike assemblies.
3Ease of operation
If a long spike needle is used to reach into containers, then access to the container interior is achieved, but the contact surface with ambient environment increases, raising contamination probability
Solution Approach 1:
The spike assembly with container perforator is designed as a disposable component that maintains its full length for effective container access during single use, then is discarded to eliminate any contamination risk from subsequent handling or exposure to ambient environment.
4Reliability
If the spike assembly is designed for single use to prevent contamination, then sterility is maintained, but the device complexity increases with disposable components
Solution Approach 1:
The device is segmented into two distinct assemblies: a disposable spike assembly containing the container perforator and a reusable hub assembly containing the air passage and liquid passage. This segmentation enables single-use sterility assurance while concentrating the complex multi-passage architecture in the reusable portion.
Solution Approach 2:
The reusable hub assembly with air and liquid passages is designed to accommodate multiple disposable spike assemblies and connect to various primary containers and injection systems. This multi-functionality reduces overall system complexity by consolidating the complex passage architecture in one reusable component rather than requiring complex passages in every disposable unit.
Data Source
AI summary
A medical container assembly is disclosed having an adapter assembly that fluidly connects with a medical container having a volume of medical fluid to accommodate multiple injections. The adapter assembly includes a spike assembly (300) that fluidly connects with the medical container, along with a spike interface cover (200) that detachably connects with the spike assembly (300). Features are incorporated by the spike assembly (300) to reduce the potential that the spike assembly (300) will be used with multiple medical containers. The spike interface cover (200) is detachably connected with the spike assembly (300) and includes features that allows the spike interface cover (200) to be used with a spike assembly (300) installed on one container, and to thereafter allow this same spike interface cover (200) to be used with another spike assembly (300) installed on another container.


