Flexible Multi-Needle Insulin Infusion Set for Low-Pain Delivery
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Solution Overview
Problem
Existing insulin infusion sets cause pain and skin scratches due to large needle diameters, are expensive, and lack localization, with issues in crumpling of subcutaneous fat layers and blockages during insulin infusion.
Innovation Solution
A needle infusion set with integrally coupled infusion needles of 31 to 33 gauges, flexible movement, and multiple channels to reduce pain and crumpling, featuring a needle fixation member and tube connection member for easy separation and attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a large diameter cannula is used for insulin infusion, then the cannula can be manufactured with sufficient strength, but it causes skin scratches and pain during insertion and removal
Solution Approach 1:
The insertion device is divided into two separate components: a needleless catheter and a separate insertion device with a sharp needle. The needle is used only during insertion to guide and penetrate the catheter through the skin, then the needle is discarded while the needleless catheter remains for insulin infusion. This segmentation allows the use of a sharp needle for insertion without leaving it in the body, and enables the use of a thinner, more flexible catheter for infusion.
Solution Approach 2:
The sharp needle is extracted from the final infusion device and used only as a temporary insertion tool. The needleless catheter is separated from the needle, allowing the needle to be removed after insertion while retaining the catheter for continuous insulin delivery. This extraction eliminates the harmful presence of a large needle in the body while maintaining insertion effectiveness.
2Device complexity
If a single infusion needle is used, then the device structure is simple, but the subcutaneous fat layer crumples during insulin infusion
Solution Approach 1:
The single infusion needle is divided into multiple separate needles (at least two) that are positioned at different locations and angles. This segmentation distributes the insulin flow across multiple entry points in the subcutaneous tissue, preventing the concentration of force and fluid that causes crumpling in a single-needle system.
Solution Approach 2:
Multiple needles are arranged in different spatial dimensions and angles relative to each other, creating a distributed infusion pattern. This dimensional arrangement spreads the insulin delivery across a wider area of subcutaneous tissue, preventing localized crumpling that occurs with a single needle.
3Device complexity
If a single infusion needle is used, then the device is simpler, but blockages occur during insulin infusion
Solution Approach 1:
The single infusion pathway is segmented into multiple separate needle pathways. Each needle provides an independent route for insulin delivery, so if one needle becomes blocked, the other needles continue to function, ensuring continuous insulin supply to the patient.
Solution Approach 2:
If one needle becomes blocked, the system can potentially discard that specific needle pathway and rely on the remaining functional needles. This redundancy provides a backup mechanism that recovers from blockage events without requiring complete system replacement.
4Reliability
If infusion sets are imported from foreign countries, then product quality may be maintained, but the cost is high and localization is lacking
Solution Approach 1:
The insertion device with the sharp needle is designed as a disposable component that is discarded after a single use. The needleless catheter and baseplate can be reused for multiple infusions. This disposable design simplifies manufacturing requirements, reduces the need for complex sterilization and quality control systems, and enables cost-effective local production while maintaining adequate quality standards.
Data Source
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AI summary
The present disclosure relates to a needle infusion set for insulin infusion, in which a diameter (0.15 gauge to 0.3 gauge) of an infusion needle is formed to be thinner than that of the related art (diameter: 0.7 gauge) and the infusion needle flexibly moves with movement of a muscle, and as a result, there is almost no feeling that the needle is inserted and there is no pain at the time of inserting or releasing the needle into or from a skin. Furthermore, two or more infusion needles are integrally configured to reduce crumpling of a subcutaneous fat layer which frequently occurs in insulin infusion.