Bi-directional Cannula Crimp for Secure Needle Shielding
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Solution Overview
Problem
Vascular access devices, particularly over-the-needle IV catheters, pose risks of accidental needle sticks and blood exposure due to the separation of the introducer needle from the catheter, with potential for blood splatter during withdrawal.
Innovation Solution
A bi-directionally engageable crimp feature on the needle, which can be locked into a shielded position using a capture mechanism, preventing proximal and distal movement to secure the needle and prevent exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the introducer needle is withdrawn from the catheter assembly, then the catheter can remain in place to provide intravenous access, but the risk of accidental needle sticks and blood exposure increases
Solution Approach 1:
The needle shield is nested within the catheter assembly, and the needle is retracted into the shield after use. The crimp feature allows the needle to be securely captured within the shield structure, creating a nested configuration that protects the sharp tip and contains any blood residue, thereby preventing accidental sticks and exposure during withdrawal and disposal
Solution Approach 2:
The crimp feature acts as an intermediary mechanism between the needle and the shield. It provides a positive engagement point that allows the needle to be securely captured and locked within the shield, serving as a mediator that ensures reliable containment and prevents unintended movement or exposure
2Ease of operation
If the needle is allowed to move freely during withdrawal, then the operation is simpler, but blood can splatter or spray from the needle when it vibrates and releases stored energy
Solution Approach 1:
The crimp feature is pre-formed on the needle before use, and the shield is pre-configured with the capture mechanism. During withdrawal, the needle is immediately captured by the shield without requiring additional manual containment actions. This preliminary preparation ensures that the needle is contained before any blood splatter risk occurs, maintaining operational simplicity while preventing harm
3Object-affected harmful factors
If a needle tip cover or shield is used to capture the needle tip, then accidental needle sticks are prevented, but the device complexity increases
Solution Approach 1:
The needle shield and capture mechanism are merged into a single integrated component that is part of the catheter assembly. The crimp feature on the needle works directly with the shield's capture mechanism without requiring separate containment devices or complex multi-component systems, thereby providing protection while minimizing added complexity
Data Source
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AI summary
A cannula, such as an IV catheter introducer needle, that has a bi-directionally engageable crimp feature (100) is described herein. The feature comprises a maximum outer diameter (102) that is greater than an outer diameter (28) of the cannula. Additionally, the feature comprises a proximal side and a distal side. The larger outer diameter of the proximal side can act as a proximal engagement that prevents the cannula from being entirely extracted in a proximal direction from a cannula shield. The distal side of the feature can comprise a notch (200) that acts a distal engagement, which prevents the cannula from reemerging distally from the shield, once the cannula has been pulled into the shield. The notch can include an engagement surface that extends laterally past the cannula's outer diameter. The engagement surface can be configured to run substantially perpendicular to the cannula's longitudinal axis.