Tamper-Resistant Medical Device Connection With Ruptureable Retaining Members
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Solution Overview
Problem
Existing medical device connections are not sufficiently tamper-resistant, risking accidental disconnection and exposure to hazardous substances during medical procedures, which can lead to safety risks for healthcare professionals and patients.
Innovation Solution
A connection arrangement featuring a first connection member and a body connected via designated ruptureable retaining members that rupture under a predetermined force, allowing the connection member to be displaced and preventing re-engagement, thereby ensuring a secure and tamper-resistant connection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional connection methods are used, then ease of operation is improved, but reliability is worsened due to risk of accidental disconnection
Solution Approach 1:
The connection arrangement incorporates ruptureable retaining members that are pre-configured to break when a specific rotational force is applied during the connection process. This preliminary action ensures that once connected, the connection becomes tamper-resistant, as the retaining members can only be broken intentionally with sufficient force, not accidentally during normal operation.
Solution Approach 2:
The connection mechanism transitions from a state where retaining members are intact and preventing rotation to a state where they are broken and allow free rotation. This parameter change in the mechanical state of the retaining members (from constrained to free) provides a clear indication that the connection has been properly secured and cannot be accidentally disconnected.
2Reliability
If ruptureable retaining members are used, then reliability is improved through tamper resistance, but device complexity increases
Solution Approach 1:
The connection arrangement is divided into distinct functional components: the body, the connection member, and multiple ruptureable retaining members. Each component has a specific function, and the retaining members are segmented as separate elements that can be individually broken. This segmentation makes the tamper-resistant mechanism clear and manageable without excessive overall complexity.
Solution Approach 2:
The ruptureable retaining members are designed as disposable, single-use components that are broken during the connection process to activate the tamper-resistant feature. After breaking, they serve their purpose and are discarded, similar to other disposable medical components. This approach provides reliable tamper resistance without requiring complex reusable mechanisms.
3Reliability
If rotating motion is required for connection, then ease of operation is worsened, but reliability is improved through fracture mechanism
Solution Approach 1:
The ruptureable retaining members are designed to resist rotational motion during the connection process, requiring a specific breaking force to be overcome. This preliminary resistance ensures that only intentional connection attempts with sufficient force will succeed, preventing accidental connections or disconnections. The rotating motion itself becomes part of the security mechanism rather than a simple operational step.
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
The solution significantly reduces the risk of accidental disconnection and leakage of toxic substances, enhancing user safety by maintaining a secure connection until the designated ruptureable retaining members are intentionally broken, allowing for safe and accurate medical device attachment.
Implementation Method 1
The at least one designated ruptureable retaining member is/are arranged to rupture when subjected to a predetermined breaking force
Data Source
AI summary
The present invention relates to a connection arrangement and a method of assembly, for providing a substantially tamper resistant connection with at least a first medical device. The connection arrangement having a center axis, the connection arrangement comprises; a first connection member for connection to the first medical device by means of a rotational motion in a first direction, and a body. Additionally the first connection member and the body are connected directly or indirectly together via at least one designated ruptureable retaining member, the designated ruptureable retaining member is arranged to rupture at a predetermined breaking force, wherein the first connection member, and thereby the first medical device after assembly, can be displaced with respect to the body after rupture. The present invention provides for a substantially tamper safe connection arrangement which disables accidents such as wrongly disengage a connected medical device. A safer handling is provided for the involved user(s).