Deflectable Retaining Element for Medical Fluid Container Attachment
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Solution Overview
Problem
Existing medical container attachment devices often fail to ensure a sterile connection and can be reused, leading to potential contamination and infection risks due to human error in sterilization processes.
Innovation Solution
An attachment device with a deflectable retaining element that prevents withdrawal from the medical container after initial connection, ensuring a secure and sterile connection by engaging the container's sidewall or interior, and incorporating design features like Luer-type connectors and auxiliary ports for fluid management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional spikes are designed to be easily removable from the medical container, then ease of operation is improved, but reliability deteriorates due to potential reuse and contamination
Solution Approach 1:
The spike incorporates a deflectable retaining element that changes its state from flexible during insertion to locked during removal prevention. This dynamic mechanism allows easy insertion while automatically preventing removal, thereby ensuring sterility without compromising ease of initial connection.
Solution Approach 2:
The retaining element automatically engages with the container sidewall or interior upon insertion, creating a self-locking mechanism that prevents removal without requiring additional components or manual intervention. This self-service feature ensures reliability while maintaining ease of operation.
2Ease of operation
If sterilization processes are performed manually by human operators, then ease of operation is improved, but reliability deteriorates due to susceptibility to human error
Solution Approach 1:
The spike and container outlet port are pre-designed with complementary geometries and retention features that ensure proper alignment and secure connection before use. This preliminary design eliminates the need for manual sterilization adjustments, reducing human error while maintaining ease of operation.
3Productivity
If the attachment device allows reuse with multiple containers, then productivity is improved, but reliability deteriorates due to increased contamination risk
Solution Approach 1:
The spike is designed as a single-use component that is discarded after one connection, eliminating contamination risk from reuse. The retaining element ensures the spike cannot be removed for reuse, enforcing the disposable nature while maintaining productivity through efficient single-use operation.
Data Source
Figure 1
Figure 2A
Figure 2B
AI summary
An attachment device for connecting a fluid path set to a medical container includes a body having a pointed distal end configured for puncturing a membrane of the medical container and a proximal end configured for connecting to the fluid path set. The attachment device further includes a fluid channel extending along a longitudinal axis of the body between the distal end and the proximal end. The fluid channel is configured for delivering a medical fluid between the medical container and the fluid path set. At least one deflectable retaining element projects from the body of the attachment device between the distal end and the proximal end. The at least one retaining element is configured from non- removably retaining the attachment device with the medical container after the attachment device is connected to the medical container.