Filtration Module for Preventing Insulin Fibrillation in Drug Delivery
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Solution Overview
Problem
Insulin solutions in continuous infusion devices tend to aggregate and form fibrils due to physical factors, leading to stability issues and potential device malfunction, especially in small micro-devices where tubing and pump materials may not be compatible with long-term exposure, accelerating fibrillation and affecting insulin delivery efficacy.
Innovation Solution
Incorporating a filtration module with a porous membrane at the reservoir outlet, featuring a mean pore size that either size-screens or adsorbs nucleation seeds, utilizing materials like Polypropylene or Polycarbonate, to prevent fibril seeds from entering the fluid pathway, thereby reducing fibrillation and maintaining device functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a continuous infusion device is used to deliver insulin, then insulin can be delivered continuously to the patient, but the insulin solution tends to aggregate and form fibrils due to physical factors such as heat, movement, and hydrophobic surfaces
Solution Approach 1:
A filtration module with a porous membrane is introduced as an intermediary component in the fluid pathway between the reservoir and the patient. This membrane selectively retains insulin fibrils while allowing insulin-containing solution to pass through, thereby preventing fibril formation in the delivered solution without interrupting continuous insulin delivery.
Solution Approach 2:
A porous membrane with specific pore size (e.g., 0.22 µm or 0.45 µm) is used in the filtration module. The porous structure allows the membrane to physically filter and retain insulin fibrils and aggregates based on size exclusion, maintaining solution stability while enabling continuous flow.
2Volume of moving object
If the infusion device has small dimensions (micro-device), then the device is more compact and portable, but the tubing and pump materials have limited compatibility with insulin for long duration exposition, accelerating fibrillation
Solution Approach 1:
The porous membrane acts as a protective intermediary barrier that isolates the insulin solution from direct contact with potentially incompatible pump and tubing materials. This prevents catalytic surfaces from accelerating fibrillation, allowing compact micro-device design without compromising insulin stability.
Solution Approach 2:
The filtration module extracts and removes fibrils and nucleation seeds from the insulin solution before they can interact with pump components or tubing surfaces. This separation prevents the acceleration of fibrillation that would otherwise occur due to limited material compatibility in small-scale devices.
3Ease of operation
If the reservoir is exposed to patient's body heat and motions for several days, then the device can be worn by the patient, but these conditions create flow movements that impart high thermo-mechanical energy to the drug solution, promoting fibril formation
Solution Approach 1:
The porous membrane serves as a protective intermediary that filters out formed fibrils and prevents further aggregation by blocking the interaction between insulin molecules and hydrophobic surfaces. This allows the reservoir to withstand patient body heat and motions without accelerating fibrillation.
Solution Approach 2:
The filtration module converts the potentially harmful effect of thermo-mechanical energy (which accelerates fibrillation) into a beneficial filtering action. By capturing fibrils formed due to heat and motion, the system transforms the harmful aggregation process into an opportunity for selective removal, maintaining solution quality despite wearable conditions.
4Reliability
If a filtration module with porous membrane is added to prevent fibril formation, then insulin delivery stability is improved, but the device complexity increases
Solution Approach 1:
The filtration module is designed to perform multiple functions: filtering fibrils, removing air bubbles, and preventing backflow. By combining these functions into a single component, the device complexity increase is minimized while achieving multiple reliability improvements simultaneously.
Solution Approach 2:
A thin porous membrane is used in the filtration module, minimizing the added volume and structural complexity. The flexible thin film design allows integration into existing device architectures without requiring significant structural modifications, thereby limiting the increase in device complexity.
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 filtration module effectively increases the lag time before fibril formation, reducing the risk of device occlusion and maintaining insulin delivery efficacy by preventing nucleation seeds from entering the downstream pathway, thus enhancing the stability and functionality of the insulin delivery system.
Implementation Method 1
a filtration module comprising a porous membrane which is adapted to absorb nucleation seeds
Implementation Method 2
a filtration module comprising a porous membrane which is adapted to absorb nucleation seeds
Data Source
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AI summary
The invention relates to a drug delivery device (1, 100), in particular for the delivery of drugs comprising molecules tending to spontaneously form nucleation seeds leading to fibrils, comprising a drug reservoir (2, 102) having a reservoir outlet (107) connected to a device outlet, adapted to deliver a drug fluid to a patient's body, through a pathway (5) including a fluid flow controlling system (4, 104). The pathway further includes a filtration module (6, 106) adapted to retain the nucleation seeds, preferably by forcing them through a filtering membrane pores and on the basis of hydrophobic interaction with the membrane.