Patch Infusion Device Reconstitution Segmentation
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Solution Overview
Problem
Current infusion devices for medicaments are cumbersome, costly, and inefficient, with issues related to user discomfort, drug stability, and bubble formation during reconstitution, which complicates the administration of insulin and other medications.
Innovation Solution
A patch-like, wearable drug reconstitution and administration system that allows for efficient mixing and storage of concentrated drugs with a liquid diluent, using a multi-component arrangement within a housing, including a cartridge and an infuser reservoir, which facilitates reconstitution and administration through a self-contained device with hidden patient needles and a pressurization system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If medicaments are stored in dry powder form to improve storage stability, then refrigeration is not needed, but reconstitution becomes difficult and involves many steps
Solution Approach 1:
The device divides the medicament storage into separate compartments: a reservoir for liquid diluent and a cartridge for dry powder medicament. This segmentation allows each component to be optimized independently - the dry powder remains stable for extended periods without refrigeration while the liquid diluent is kept sterile, and reconstitution is simplified by bringing these compartments together through a single mixing action.
Solution Approach 2:
The mixing chamber acts as an intermediary space where the liquid diluent from the reservoir and dry powder medicament from the cartridge are combined. This intermediate mixing zone facilitates easy reconstitution by providing a controlled environment for mixing, from which the reconstituted solution can then be transferred to the infusion reservoir.
2Object-generated harmful factors
If ultrasonic energy is applied to remove bubbles from reconstituted formulations, then bubbles are disrupted, but specialized bulky equipment and power sources are required
Solution Approach 1:
The device extracts and removes air bubbles from the reconstituted medicament solution through a filtration system integrated into the transfer mechanism. As the reconstituted solution is moved from the mixing chamber to the infusion reservoir, the filtration system captures and removes bubbles, eliminating the need for complex ultrasonic debubbling equipment while ensuring the infusion solution is free of harmful air embolisms.
3Object-generated harmful factors
If high pressure is applied to reduce bubble formation, then bubble collapse is increased, but additional equipment safeguards are needed and bubbles form again after pressure removal
Solution Approach 1:
The device performs preliminary bubble removal through its integrated filtration system before the reconstituted solution enters the infusion reservoir. This preliminary action ensures that bubbles are removed in advance, eliminating the need for high-pressure treatment and its associated safety risks. The filtration system is designed to continuously remove bubbles during the transfer process, providing reliable bubble-free infusion without requiring complex pressure control equipment.
4Measurement precision
If infusion pumps are used to provide continuous infusion and precision dosing, then glucose control is improved, but cost is 8 to 10 times higher than syringe therapy
Solution Approach 1:
The device employs a disposable design where the entire infusion system including the reservoir, mixing chamber, and cartridge is intended for single use and then discarded. This eliminates the need for expensive reusable infusion pumps while maintaining precision dosing capabilities. The disposable nature ensures sterility and eliminates the high costs associated with pump purchase, maintenance, and sterilization, making precision insulin delivery accessible at a fraction of the traditional pump cost.
5Quantity of substance
If wearable infusion devices are made disposable to reduce cost, then cost and inconvenience are reduced, but user discomfort and malfunction risk increase
Solution Approach 1:
The device merges multiple functions into a single integrated disposable unit: the reservoir for diluent, the cartridge for medicament, the mixing chamber for reconstitution, the filtration system for bubble removal, and the infusion mechanism are all combined in one pre-assembled device. This integration eliminates the need for multiple separate components that could fail or be improperly assembled, reducing malfunction risk while maintaining low cost and disposable convenience.
Solution Approach 2:
The device incorporates pre-assembled safety features and protective mechanisms before use, including sterile barriers, secure locking mechanisms to prevent premature activation, and integrated filtration systems. These beforehand precautions ensure reliable operation while maintaining the disposable, low-cost advantage, as the safety features are built-in rather than requiring complex external systems.
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 system provides a stable, user-friendly, and cost-effective method for administering medicaments by minimizing bubble formation and ensuring efficient reconstitution, mimicking pre-mixed liquid formulations, while reducing the need for refrigeration and simplifying the administration process.
Implementation Method 1
a pressurization system for pressurizing the substance in the reservoir
Data Source
AI summary
A system and method for a patch-like, self-contained multi-component substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir assembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. The device can be attached to a skin surface via an adhesive contact and a pressurization system provides a pressure to the contents of a fluid reservoir assembly. Improvements to dry powdered formulations for reconstitution for preferred use in the device are also disclosed.