Helical Cannula Infusion Set for Kinkless Subcutaneous Insertion
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Solution Overview
Problem
Current infusion sets for delivering therapeutics are prone to kinking during insertion, leading to ineffective medication delivery, increased pain, and high costs due to frequent replacements, as they provide reduced therapeutic benefit after 24 hours and require deep insertion with introducer needles, causing discomfort and intimidation to users.
Innovation Solution
A kinkless infusion set with a helical cannula that is rotated and translated using a setting control to position it accurately under the skin, reducing the likelihood of kinking and allowing for repositioning to maintain therapeutic effectiveness over an extended period without the need for frequent replacements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional infusion set with introducer needle is used for deep insertion, then the cannula can be positioned under the skin, but the cannula is prone to kinking during insertion which reduces reliability
Solution Approach 1:
The cannula is designed with a helical (curved) configuration instead of a straight form. This helical shape allows the cannula to be inserted subcutaneously without kinking, as the curved structure naturally accommodates the insertion path and tissue displacement. The helical geometry prevents the cannula from folding back on itself during insertion, thereby eliminating the harmful kinking effect while maintaining reliable positioning.
Solution Approach 2:
The cannula incorporates a flexible, dynamically adaptable structure that can bend and conform to tissue during insertion. The cannula's flexible design allows it to dynamically adjust to the insertion forces and tissue resistance, preventing rigid kinking while maintaining its functional integrity for medication delivery.
2Length of moving object
If an introducer needle is used for deep insertion, then the cannula can reach therapeutic depth, but the insertion process causes increased pain and user intimidation
Solution Approach 1:
The introducer needle component is completely removed from the infusion set design. The helical cannula is designed to be inserted directly without requiring an introducer needle, thereby eliminating the additional pain and discomfort associated with needle penetration while still achieving the necessary therapeutic insertion depth through its helical geometry and flexible structure.
Solution Approach 2:
The helical curved shape of the cannula allows it to penetrate and position itself subcutaneously more gently than a straight rigid needle. The curved path distributes insertion forces more evenly and reduces the shock of penetration, thereby reducing pain and user intimidation while achieving the required insertion depth.
3Duration of action of moving object
If a conventional infusion set is used, then initial medication delivery is effective, but therapeutic benefit is reduced after 24 hours requiring frequent replacements
Solution Approach 1:
The helical cannula is pre-configured with a specific curved geometry and flexibility characteristics that are optimized for long-term subcutaneous positioning. This preliminary design ensures that the cannula maintains its intended configuration during insertion and throughout use, preventing kinking and displacement that would otherwise reduce effectiveness after 24 hours. The pre-engineered helical structure proactively prevents the development of kinks that compromise medication delivery.
Solution Approach 2:
The cannula's physical parameters—specifically its helical geometry, curvature radius, and flexibility modulus—are optimized to maintain structural integrity and functional reliability over extended periods. These parameter changes from conventional straight, rigid designs enable the cannula to withstand tissue movement and pressure without kinking, thereby maintaining consistent medication delivery effectiveness beyond 24 hours.
4Reliability
If conventional infusion sets are replaced frequently, then kinking and ineffectiveness are avoided, but costs increase significantly
Solution Approach 1:
The helical curved design of the cannula inherently prevents kinking during both insertion and use, eliminating the primary reason for infusion set failure and replacement. This design feature allows the infusion set to maintain its reliability throughout the intended wear period without developing kinks that would compromise medication delivery, thereby reducing the frequency of replacements and associated costs.
Solution Approach 2:
The invention transforms the disposable infusion set from a short-lived product requiring frequent replacement into a more durable, reusable component. The helical cannula's resistance to kinking and structural degradation extends the functional life of the infusion set, reducing the number of disposable units needed and lowering overall consumption and cost.
Data Source
AI summary
Briefly, a kinkless infusion set has a setting control that engages a curved or helical cannula to simultaneously rotate the helical cannula as the helical cannula is moved toward a patients skin and then under the patient's skin to position the curved or helical cannula to a desired depth and position. In one example, the helical cannula is set between 3 mm and 5 mm under the patient's skin. Also, the curved or helical cannula may have side ports to allow medicine to be presented over a larger area for more effective therapeutic treatment. In some constructions the patient rotates the setting control, and in other cases the patient may push, pull or translate the setting control.