Single-Handed Catheter Insertion Device with Integrated Safety Clip
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Solution Overview
Problem
Existing catheter insertion devices require two hands for insertion, increasing the risk of contamination and vessel damage due to unintended needle movement, and hinder continuous ultrasound use.
Innovation Solution
A catheter insertion device with a handle, needle cannula, guidewire, and actuators that allow single-handed operation, featuring a slider to move the guidewire and a second actuator to advance the catheter, along with a needle safety clip and hemostasis valve for sterility and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If two hands are used for insertion of guide wire and catheter, then the insertion can be completed, but the risk of contamination increases and vessel damage risk increases
Solution Approach 1:
The patent combines the functions of needle insertion, guidewire advancement, and catheter delivery into a single integrated device that can be operated with one hand. The needle assembly, guidewire, and catheter are pre-positioned relative to each other, allowing the operator to perform all insertion steps without releasing the handle, thus maintaining sterility while enabling single-handed operation.
Solution Approach 2:
The device is designed to perform multiple functions automatically once the needle is inserted. The guidewire is pre-loaded and can be advanced by simply releasing a latch mechanism, and the catheter follows automatically over the guidewire. This self-service design reduces the need for manual manipulation of individual components, minimizing contamination risk.
2Reliability
If two hands are used for insertion operations, then the insertion can be completed, but the risk of unintended needle point movement and vessel damage increases
Solution Approach 1:
The patent integrates the needle, guidewire, and catheter into a single coordinated system where the needle provides stable support during the entire insertion process. The guidewire is pre-positioned within the needle, and the catheter is pre-positioned over the guidewire, creating a stable configuration that prevents unintended needle movement while enabling single-handed operation.
Solution Approach 2:
The guidewire and catheter are pre-loaded and pre-positioned relative to the needle before insertion. This preliminary arrangement ensures that once the needle is safely in the vessel, the guidewire and catheter are already in position to follow, eliminating the need for subsequent manual manipulation that could cause needle movement or vessel damage.
3Reliability
If two hands are used for insertion, then the insertion can be completed, but continuous ultrasound use is prevented
Solution Approach 1:
The device is designed to perform guidewire advancement and catheter delivery automatically after needle insertion. The operator simply needs to release a latch mechanism, and the stored energy in the spring-loaded system advances the guidewire and catheter without requiring the operator to use their hands for manipulation, allowing continuous ultrasound monitoring throughout the procedure.
4Reliability
If fingers contact the needle, guidewire and catheter during operation, then the insertion can be completed, but sterility is compromised
Solution Approach 1:
The patent combines multiple components (needle, guidewire, catheter) into a single integrated assembly that is manipulated as one unit. The operator interacts only with the external handle and release mechanisms, which are designed to be non-sterile. The sterile components remain enclosed within the handle throughout the procedure, preventing finger contact and maintaining sterility while still allowing full manual control of the insertion process.
Data Source
AI summary
A catheter insertion device that allows for insertion of a catheter within vasculature of a patient is disclosed. The catheter insertion device includes a handle and a needle cannula held within the handle. A guidewire is partially disposed within the needle cannula. The guidewire is slidable within a lumen of the needle cannula. A first actuator is connected to the handle and the guidewire, and is movable relative to the handle to move the guidewire relative to the handle. A catheter and catheter hub are configured to move relative to the handle and slide over the cannula during deployment of the catheter into the vasculature of the patient. A needle safety clip covers a sharp distal tip of the cannula following removal of the needle cannula from the catheter hub.