Alternative Fluidic Pathing for Serial Drug Modules with Sterile Venting
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Solution Overview
Problem
Existing pharmacy compounding systems for intravenous infusion face challenges such as needle-stick injuries, medication errors, drug waste, and high costs due to complex machinery, especially when preparing synergistic combinations of drugs like checkpoint inhibitors and cytotoxic agents.
Innovation Solution
A modular system of drug modules with vial chambers, interchangeable adapters, and sterile tubing for fluid paths, allowing serial connection and integration with a base tray, featuring automatic fluid connections, pressure equalization, and venting to prevent contamination, enabling preparation of drug combinations at non-pharmacy locations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmacy compounding machines are used to automate drug preparation, then the risk of needle-stick injuries and medication errors is reduced, but the device complexity and cost increase significantly
Solution Approach 1:
The system is divided into separate functional modules: a compounding module for drug preparation and a delivery module for administration. This segmentation allows the complex automation functions to be isolated in a dedicated unit while simplifying the overall system integration and reducing the complexity burden on the delivery component.
Solution Approach 2:
A sterile adapter or interface component serves as an intermediary between the compounding machine and the delivery system. This intermediary maintains sterility barriers while enabling automated fluid transfer, thus reducing needle-stick risks without requiring direct mechanical integration of the entire system.
2Manufacturing precision
If complex electromechanical compounding machines are deployed, then drug preparation accuracy improves, but the cost and size of the system increase
Solution Approach 1:
The compounding system incorporates self-priming fluid pathways and automatic air-liquid interface detection that allow the machine to self-regulate flow rates and mixing ratios without complex external control systems. This maintains compounding accuracy while reducing the need for sophisticated electromechanical components.
Solution Approach 2:
The system uses adjustable flow rate parameters and mixing ratios that can be programmed for different drug combinations. By changing operational parameters rather than physical configurations, the system maintains precision across various drug types without requiring multiple specialized machines, thus reducing overall cost and size.
3Productivity
If drugs are drawn from stock reservoirs in automated systems, then compounding efficiency improves, but unused drug solutions are wasted due to sterility requirements
Solution Approach 1:
The system pre-fills syringes or reservoirs with exact doses required for each patient specific to each patient's prescription. This preliminary dosing action ensures that only the necessary amount of each drug is prepared and transferred, eliminating waste from unused portions while maintaining sterility through closed-system transfer mechanisms.
Solution Approach 2:
The system incorporates mechanisms to recover and reuse sterile components such as adapters, connectors, and fluid pathways after a single use. By recovering these non-drug components, the system maintains high compounding efficiency without the need to discard entire drug-containing systems, thus reducing drug waste while preserving productivity.
4Device complexity
If manual drug preparation is performed, then equipment cost is reduced, but the risk of needle-stick injuries and medication errors increases
Solution Approach 1:
The system extracts the hazardous functions of needle handling and drug transfer from manual operations and places them within a closed automated system. The practitioner interacts only with external interfaces that do not require direct needle manipulation, thus maintaining equipment simplicity from the user's perspective while eliminating safety risks through automation of the dangerous steps.
Solution Approach 2:
The system uses disposable sterile adapters and single-use fluid transfer components that are inexpensive to manufacture. These disposable elements maintain safety by eliminating the need for complex sterilization protocols and repeated cleaning, thus keeping the overall system simple while ensuring high reliability through fresh sterile barriers for each compounding event.
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
Reduces needle-stick risks, minimizes drug waste, and lowers costs by allowing flexible, portable, and safe preparation of drug combinations, including synergistic therapies, at locations like patient homes.
Implementation Method 1
a vent, including a vent terminated by an aseptic particulate filter that enables the equalization of pressure within the vial during removal of liquid drug from the vial whilst preventing the entrainment of contaminants into the fluid path
Data Source
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AI summary
Various embodiments are disclosed herein related to fluidic connections for modules useable in combinatorial drug delivery devices. The fluidic connections allow for variable flow paths to be defined for serially-connected, and base-tray mounted, modules.