Halogenated Siloxane Septum in Extended-Wear Insulin Infusion Sets
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Solution Overview
Problem
Extended wear infusion sets face challenges in maintaining insulin stability due to preservative loss from elastomeric septums, leading to insulin degradation and infusion site complications.
Innovation Solution
Incorporation of halogenated siloxane materials in the septum composition to prevent phenolic preservative absorption, maintaining mechanical robustness and providing a barrier to preserve insulin's anti-microbial effectiveness over extended wear.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If elastomeric septums are used in infusion sets, then mechanical robustness and sealing are achieved, but preservative loss occurs leading to insulin degradation
Solution Approach 1:
The patent uses a composite material system consisting of an elastomeric base material (providing mechanical robustness) combined with a fluorinated polymer coating (providing preservative barrier properties). This composite structure allows the septum to maintain both its mechanical strength and its ability to prevent phenolic preservative loss, resolving the contradiction between durability and substance retention.
Solution Approach 2:
The patent modifies the chemical parameters of the septum surface by applying a fluorinated polymer coating, which changes the surface properties to be more hydrophobic and less permeable to phenolic preservatives. This parameter change maintains the mechanical properties while significantly reducing preservative absorption and loss.
2Duration of action of moving object
If extended wear infusion sets are developed for longer duration, then infusion site rotation frequency is reduced, but preservative loss increases leading to insulin instability
Solution Approach 1:
The fluorinated polymer coating creates a composite structure that provides long-term preservative retention. The coating's low permeability to phenolic preservatives ensures that even over extended wear periods (7 days or longer), sufficient preservative remains in the insulin formulation to prevent degradation and aggregation, thus resolving the contradiction between extended duration and substance loss.
Solution Approach 2:
The patent employs a disposable infusion set with a specially coated septum that is designed to last for extended periods without requiring replacement. The fluorinated polymer coating ensures that the preservative loss remains acceptable throughout the entire wear period, making the extended wear design feasible and safe.
3Stability of the object's composition
If phenolic preservatives are used to maintain insulin stability, then insulin precipitation is inhibited, but preservative absorption into fluid path materials occurs
Solution Approach 1:
The fluorinated polymer coating changes the surface parameters of the septum to be highly hydrophobic and chemically inert toward phenolic preservatives. This parameter change creates a barrier that prevents preservative absorption into the fluid path materials, thereby maintaining insulin stability without significant preservative loss.
Solution Approach 2:
The fluorinated polymer coating acts as an intermediary layer between the insulin formulation and the elastomeric septum. This intermediate layer prevents direct contact and absorption of phenolic preservatives by the septum material, while still allowing the preservatives to function in maintaining insulin stability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Halogenated siloxane septums reduce preservative loss, ensuring insulin stability and reducing the risk of insulin aggregate propagation, suitable for extended wear infusion sets.
Implementation Method 1
Preservative loss in an insulin delivery system is often a two-stage process that includes: (1) absorption of the preservative into fluid-path materials
Implementation Method 2
After the material is saturated, preservative loss from drug product is driven by the rate of preservative diffusion through the material and evaporation into the surrounding environment
Implementation Method 3
preservative loss from drug product is driven by the rate of preservative diffusion through the material and evaporation into the surrounding environment
Data Source
AI summary
Disclosed herein are improved infusion sets that incorporate halogenated siloxane materials within the composition of an infusion set septum. Such configurations maintain the mechanical robustness of using elastomeric materials for a fluidic septum while providing barrier properties that prevent phenolic preservative from being absorbed out of the infusion set. Infusion sets as disclosed herein are particularly suitable for maintaining insulin's anti-microbial effectiveness over extended wear (e.g., 7 days) to maintain performance of the infusion set during extended wear and reduce the risk of insulin aggregate propagation.