Infusion Set Sorbent to Remove m-Cresol
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Solution Overview
Problem
Current insulin infusion set devices for continuous subcutaneous insulin infusion (CSII) have limited wear time due to inflammatory and foreign body responses at the infusion site, primarily caused by phenolic excipients, which impairs insulin uptake and increases the risk of hyperglycemia, limiting the longevity of the infusion site and compatibility with integrated artificial pancreas systems.
Innovation Solution
Incorporation of sorbent materials along the fluid pathway to adsorb or absorb phenolic excipients like m-cresol, use of medicaments to reduce inflammation, and a dispersive catheter design to deliver insulin in a diffuse manner, increasing exposure time and surface area contact with the sorbent materials to enhance sorption and minimize site reactions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If phenolic excipients (e.g., m-cresol) are used in insulin formulation, then insulin stability and preservation are improved, but inflammatory and foreign body responses at the infusion site increase, limiting wear time to 2-3 days
Solution Approach 1:
The patent extracts and removes phenolic excipients (m-cresol) from the insulin formulation using a sorbent material integrated into the infusion set. The sorbent material selectively binds and removes these harmful preservatives while allowing insulin to pass through, thereby eliminating the inflammatory response caused by phenolic compounds while maintaining insulin delivery functionality
Solution Approach 2:
The sorbent material acts as an intermediary component between the insulin reservoir and the patient's tissue. It mediates the interaction by selectively removing harmful phenolic excipients from the insulin formulation while permitting insulin molecules to reach the subcutaneous tissue, thus resolving the conflict between preservation needs and biocompatibility
2Object-affected harmful factors
If sorbent material is added to remove phenolic excipients, then inflammatory response is reduced, but device complexity increases
Solution Approach 1:
The sorbent material is merged with existing components of the infusion set, such as the catheter or tubing, rather than being added as a separate standalone component. This integration approach reduces device complexity by combining multiple functions (insulin delivery and excipient removal) into a single unified structure
Solution Approach 2:
The sorbent material utilizes a porous structure that allows insulin molecules to pass through while trapping phenolic excipients. The porous architecture provides high surface area for sorption while maintaining fluid flow characteristics similar to conventional tubing, thereby minimizing the impact on device complexity
3Ease of operation
If wear time is extended beyond 2-3 days, then convenience and integration with artificial pancreas systems improve, but insulin uptake efficiency decreases due to site impairment
Solution Approach 1:
The sorbent material performs preliminary action by removing phenolic excipients from the insulin formulation before the insulin reaches the infusion site. This pre-treatment prevents the inflammatory response from developing in the first place, thereby maintaining site integrity and insulin uptake efficiency throughout the extended wear period
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
The solution extends the viability of CSII infusion sites beyond 3 days, reducing insulin waste and scarring, enabling a more convenient and integrated artificial pancreas system with reduced need for frequent device changes.
Implementation Method 1
a sorbent material configured to contact the insulin formulation and collect phenolic excipients (e.g., m-cresol, phenol, methylparaben, ethylparaben, butylbaraben, other preservatives, and combinations thereof) from the insulin formulation by sorption, such as adsorption and/or absorption
Data Source
AI summary
An insulin infusion set (IIS) device with one or more features designed to achieve longevity in a patients continuous subcutaneous insulin infusion (CSII) site viability. One exemplary feature is an adsorbent material configured to adsorb phenolic excipients (e.g., m-cresol or other preservatives) from the insulin formulation. The adsorbent material may be positioned along a fluid pathway specifically designed to increase and/or extend exposure between the insulin formulation and the adsorbent material. Another exemplary feature is a medicament configured to reduce the patients inflammation or slow the progression of the patients inflammatory response. Yet another exemplary feature is a diffusive catheter configured to deliver the insulin formulation in a diffuse manner.