Integrated Insulin Infusion Device with Retractable Needle
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Solution Overview
Problem
Conventional insulin infusion systems are cumbersome due to the need for multiple components, including separate inserters and infusion sets, which can lead to incomplete adhesion, kinking of soft cannulas, and discomfort during use, especially with the high-speed deployment of introducer needles and adhesives.
Innovation Solution
An integrated inserter and infusion set that includes a retractable introducer needle, allowing for a single-step manual deployment with the introducer needle and catheter, ensuring full adhesion and correct depth, while isolating the catheter from external forces and preventing kinking through structural support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If a separate high-impact spring-loaded inserter is used to propel the introducer needle and cannula, then the insertion speed and depth control are improved, but the device complexity and number of components increase
Solution Approach 1:
The patent combines the inserter and infusion set into a single integrated device. The hub serves as both the adhesive base and the insertion mechanism housing, eliminating the need for separate inserters. The spring mechanism is integrated within the hub structure, propelling the introducer needle and cannula directly from the adhesive base.
Solution Approach 2:
The hub performs multiple functions: it serves as the adhesive base for skin attachment, houses the spring-loaded insertion mechanism, and provides structural support during insertion. This multi-functional design eliminates the need for separate dedicated inserter devices while maintaining insertion effectiveness.
2Ease of operation
If ballistic insertion is used to deploy introducer needle, catheter, and adhesive simultaneously, then the insertion process is simplified, but adhesion completeness and catheter insertion accuracy deteriorate
Solution Approach 1:
The patent divides the insertion process into two distinct phases: first, the adhesive hub is applied to the skin and allowed to adhere; second, the spring mechanism is activated to propel the introducer needle and cannula into the skin. This segmentation ensures proper adhesion before insertion and maintains catheter alignment accuracy.
Solution Approach 2:
The adhesive hub is applied to the skin and allowed to fully adhere before the insertion mechanism is activated. This preliminary adhesion step ensures the hub is securely fixed to the skin, providing a stable base for accurate catheter insertion and preventing displacement during the insertion process.
3Object-affected harmful factors
If soft Teflon-based cannula is used for infusion, then user comfort is improved, but the cannula is prone to kink which can interrupt insulin delivery
Solution Approach 1:
The patent provides structural support specifically at the insertion site where the cannula exits the hub. The hub structure and introducer needle design offer localized reinforcement to prevent kinking at the critical exit point, while maintaining the overall softness and comfort of the Teflon cannula for subcutaneous infusion.
Solution Approach 2:
The system combines the soft Teflon cannula material with the rigid structural support of the hub and introducer needle mechanism. This composite approach maintains the comfort benefits of soft Teflon while preventing kinking through the structural framework provided by the integrated insertion device.
4Reliability
If introducer needle extends beyond cannula for initiation of penetration, then insertion effectiveness is improved, but needle exposure and user discomfort increase
Solution Approach 1:
The patent employs a spring-loaded mechanism that dynamically controls the extension and retraction of the introducer needle. The needle extends beyond the cannula only during the brief insertion moment when needed for effective skin penetration, then retracts automatically after insertion, minimizing user exposure and discomfort while maintaining insertion effectiveness.
Solution Approach 2:
The spring mechanism is pre-loaded to provide the necessary force for effective insertion when the needle extends beyond the cannula. After insertion, the spring automatically reverses the action, retracting the needle to minimize exposure. This preliminary preparation of the spring mechanism ensures both effective insertion and subsequent needle retraction.
Data Source
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Figure 4A~4C
Figure 5A~5C
AI summary
An infusion system having an integrated inserter and infusion set (10) for containing and placing a flexible catheter (40), and a retractable introducer needle (26), wherein the catheter (40) is isolated from movement after placement. The integrated inserter and infusion set (10) includes a hub (20), having a user push button (30) to activate the device for catheter (40) placement. An adhesive liner (34) can be provided to cover an adhesive layer (36), such as pressure sensitive adhesive (PSA), on the bottom of the device (10).