Infusion Device Automatic Needle Retraction
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Solution Overview
Problem
Current infusion systems for insulin delivery face challenges with variability in catheter insertion and retraction forces, leading to increased failure rates and accidental needle sticks due to the need for manual handling of separate insertion devices and multiple components.
Innovation Solution
An integrated infusion device with automatic insertion and retraction capabilities, featuring a single unit with a push-button or rotary activation mechanism, and interlocks to ensure proper catheter placement and safety, reducing the number of components and minimizing needle exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual insertion and retraction of the introducer needle is used, then the user has control over the process, but variability in insertion and retraction force, speed, smoothness and angle leads to increased catheter insertion failure
Solution Approach 1:
The patent combines the introducer needle, catheter, and insertion device into a single integrated assembly. The introducer needle and catheter are pre-connected, and the entire assembly is automatically inserted and retracted by the device itself, eliminating the need for separate manual handling of multiple components and ensuring consistent insertion parameters.
Solution Approach 2:
The insertion device is designed to automatically insert and retract the introducer needle-catheter assembly without requiring manual manipulation. The device performs the insertion and retraction functions itself through automated mechanical mechanisms, ensuring consistent force, speed, and angle while eliminating variability introduced by manual operation.
2Object-affected harmful factors
If the introducer needle is completely removed from the infusion set before connection to the pump, then the needle can be sterilized separately, but the user is exposed to accidental needle sticks from handling the removed introducer needle
Solution Approach 1:
The patent integrates the introducer needle with the catheter and insertion device into a single unit. The needle remains attached to the catheter throughout the insertion process and is automatically retracted into the device housing after catheter placement, eliminating the need for separate needle handling and disposal while maintaining sterile conditions.
Solution Approach 2:
The patent extracts the introducer needle from the infusion set after catheter insertion by automatically retracting it into the insertion device housing. This separates the needle from the catheter at the appropriate time while minimizing user exposure, as the needle is retracted into a protected position rather than being completely removed and handled manually.
3Reliability
If a stand-alone insertion device is used that requires manual loading of the set and compression of a spring, then the device can be simple in structure, but catheter insertion failure occurs when the set or spring is not properly loaded or compressed
Solution Approach 1:
The patent incorporates a pre-loaded spring mechanism within the insertion device that is prepared in advance for insertion. The spring is pre-compressed during device assembly or activation, ensuring consistent insertion force is available when needed, eliminating the need for manual spring compression by the user and ensuring reliable catheter insertion.
Solution Approach 2:
The insertion device automatically manages the spring loading and compression processes without requiring manual intervention. The device self-regulates the insertion force through its internal spring mechanism, ensuring consistent performance while simplifying user operation. The spring is automatically re-loaded or replaced as part of the device's operational cycle.
Data Source
AI summary
An infusion device (10) includes one or more of automatic insertion and retraction of an introducer needle (40) and catheter (28), introducer needle safety and extension set. The device (10) can further comprise a top-push button (16) activation feature, a side-push button (402) activation feature or a rotary-button (412) activation feature, and one or more of a manual interlock of an outer barrel and base, and a manual interlock for an extension set top and base. Packaging (500) for an integrated and/or removable inserter with activation button protection is also disclosed.