Tamper-Evident Closure With Actuatable Door For Medical Access
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Solution Overview
Problem
Patients, especially those with psychiatric conditions, intellectually delayed individuals, pediatric patients, or intravenous drug users, may tamper with intravenous access points, leading to unintended medication delivery and potential medical complications due to unsupervised access to vascular access devices.
Innovation Solution
A tamper-evident closure system for medical access devices featuring an actuatable door with a hinge, a securing strap with an area of weakness, and a closure mechanism that visually indicates tampering by breaking the strap, ensuring the device cannot be resealed without evidence of access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tamper-evident closure completely seals the medical access device, then patient safety is improved by preventing unauthorized access, but the ability to legitimately access the device for medical treatment is reduced
Solution Approach 1:
The closure is segmented into a main body and a separate actuatable door that can be opened for legitimate medical access. This segmentation allows the closure to maintain overall security while providing controlled access points that do not compromise the tamper-evident nature of the main sealing mechanism.
Solution Approach 2:
The actuatable door serves as an intermediary element between the secure sealed state and the accessed state. It provides a controlled transition mechanism that allows legitimate access while maintaining the integrity of the main closure system and ensuring that any access attempt is visually indicated.
2Ease of operation
If an actuatable door is added to allow legitimate access, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The actuatable door utilizes flexible material construction that allows it to be actuated and return to its original position. This flexibility simplifies the door mechanism compared to rigid moving parts, reducing overall device complexity while maintaining the ability to provide controlled access.
Solution Approach 2:
The door mechanism is designed to be self-contained and self-actuating without requiring additional complex mechanisms. The door can be opened and closed through simple user action, and its position (open or closed) self-indicates the access status, reducing the need for additional sensors or indicators.
3Reliability
If the closure is made fully sealed without access points, then tamper evidence is improved, but the ability to accommodate various medical access device arrangements is reduced
Solution Approach 1:
The closure transitions from a static fully-sealed design to a dynamic system with an actuatable door. This dynamic element allows the closure to adapt to different medical access device configurations and access requirements while maintaining tamper-evident capabilities, as the door's position and any access attempts are visually indicated.
Data Source
AI summary
The disclosed tamper-evident closure (100) encloses a medical access device (200), such as a vascular access device and includes an actuatable door (127) to create an optional access point (113) for accommodating various arrangements of medical access devices within the tamper-evident closure. The tamper-evident closure comprises a holding cavity (110), an access point into the holding cavity, an actuatable door covering the access point, and a hinge (127c) connecting the actuatable door to the holding cavity.