Insulin Infusion Preservative Removal via Cyclodextrins
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Solution Overview
Problem
Current insulin infusion sets have limited approved lifespan and often fail to meet this duration in practical use, leading to inflammation and scarring at insulin infusion sites, which compromises the effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) therapy.
Innovation Solution
The use of cyclodextrins and cyclodextrin polymers to replace preservatives and fibrils in insulin formulations, along with ion exchange resins to remove insulin preservatives, and the incorporation of anti-proteases and anti-inflammatory agents to prevent degradation and inflammation, is proposed to enhance insulin delivery and reduce tissue reactions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If phenol and m-cresol are used as preservatives in liquid insulin formulation, then the insulin formulation maintains stability and prevents bacterial growth, but tissue inflammation and scarring occur at the infusion site
Solution Approach 1:
The patent removes phenol and m-cresol preservatives from the liquid insulin formulation through filtration systems incorporating ion exchange resins and cyclodextrin polymers, extracting the harmful substances while retaining the therapeutic insulin
Solution Approach 2:
The patent introduces cyclodextrin polymers and ion exchange resins as intermediary substances that bind to and remove preservatives and fibrils from the insulin formulation, acting as mediators between the harmful components and the therapeutic insulin
2Object-affected harmful factors
If the approved lifespan of insulin infusion sets is limited to 3 days, then tissue reactions are minimized, but treatment continuity and quality of life are compromised
Solution Approach 1:
The patent incorporates fibril removal filtration systems and preservative removal systems into the infusion set before use, performing preliminary actions to eliminate harmful substances that would otherwise cause tissue reactions and limit infusion set lifespan
Solution Approach 2:
The patent changes the chemical composition parameters of the insulin formulation by removing phenol, m-cresol, and fibrils, thereby altering the biological response at the infusion site and extending the usable lifespan of the infusion set
3Stability of the object's composition
If insulin formulations contain preservatives and fibrils, then the formulation remains stable during storage, but tissue injury and inflammation occur at the infusion site
Solution Approach 1:
The patent extracts preservatives and fibrils from the insulin formulation using filtration systems with ion exchange resins and cyclodextrin polymers, removing the harmful components that cause tissue injury while maintaining insulin stability
Solution Approach 2:
The patent uses composite filtration materials combining ion exchange resins and cyclodextrin polymers to simultaneously remove multiple harmful substances (preservatives and fibrils) from the insulin formulation
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
This approach extends the lifespan of insulin infusion sets, reduces inflammation and scarring, and maintains effective glucose regulation by stabilizing insulin and preventing tissue damage.
Implementation Method 1
replacing at least one of phenol and m-cresol with at least one of cyclodextrins, cyclodextrin polymers and cyclodextrin beads
Implementation Method 2
incorporating at least one of an ion exchange resin and cyclodextrin polymers or beads into the infusion set
Implementation Method 3
incorporating at least one of an ion exchange resin and cyclodextrin polymers or beads into the infusion set
Implementation Method 4
incorporating an anti-protease into the insulin formulation
Implementation Method 5
delivering an anti-inflammatory drug, factor or agent to (a) the insulin formulation or (b) during an insulin infusion
Implementation Method 6
introducing vascular endothilial growth factor to the infusion site
Data Source
AI summary
Products, systems and methods are disclosed for lowering the concentrations of at least one of preservatives and fibrils in a liquid insulin composition. One method comprises replacing at least a portion of at least one of phenol and m-cresol with at least one of cyclodextrins, cyclodextrin polymers, cyclodextrin beads, and an ion exchange resin.