Drug Delivery Reconstitution System with Integrated Pump
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Solution Overview
Problem
The current process of reconstituting lyophilized drugs for administration is time-consuming, error-prone, and requires a sterile environment, often involving multiple needles and cumbersome hood usage, which can be hazardous and inefficient, especially for complex oncology products like Bi-specific T-cell Engagers.
Innovation Solution
A drug delivery system comprising a diluent container, a drug product container, and a pump that fluidly connects the two for reconstitution, eliminating the need for multiple needles and allowing for prefilled, premixed components, reducing preparation complexity and time while maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple needles and syringe systems are used for reconstitution, then the drug can be properly prepared, but the process becomes time-consuming and increases exposure to potential needle hazards
Solution Approach 1:
The patent combines multiple separate needle and syringe systems into a single integrated reconstitution system. The closed system allows diluent to be transferred to the drug vial and the reconstituted drug to be transferred to the infusion bag using one connected system, eliminating the need for multiple separate needle insertions and syringe transfers.
Solution Approach 2:
The patent introduces a closed system transfer device as an intermediary between the diluent vial, drug vial, and infusion bag. This intermediary mechanism enables fluid transfer without direct needle-syringe manipulation, maintaining sterility while reducing preparation steps and time.
2Reliability
If a hood is used to provide sterile environment, then sterility is maintained, but the process becomes cumbersome and complex
Solution Approach 1:
The closed system transfer device acts as an intermediary that maintains the sterile barrier, allowing the reconstitution process to occur without requiring a hood. The system's built-in sterile connections and closed architecture replace the need for external sterile field maintenance.
Solution Approach 2:
The reconstitution system is self-contained with pre-sterilized components and closed connections that maintain sterility automatically during the process. The system serves its own sterility maintenance function without requiring external hood infrastructure or complex sterile technique procedures.
3Reliability
If multiple needles and syringes are used for reconstitution, then the drug can be properly prepared, but the error rate increases
Solution Approach 1:
The patent merges multiple separate manipulation steps into a single integrated system operation. By combining the diluent transfer, drug reconstitution, and final transfer to infusion bag into one connected system, the number of manual operations is reduced, thereby reducing opportunities for user error.
Solution Approach 2:
The closed system provides visual and tactile feedback mechanisms that guide the operator through the reconstitution process, ensuring correct connections and proper fluid transfer. The system's design inherently prevents incorrect dosing through its structured flow path and connection requirements.
4Object-affected harmful factors
If CSTD and engineering controls are used for hazardous drugs, then safety is improved, but the device complexity and preparation time increase
Solution Approach 1:
The patent combines the hazardous drug protection function with the reconstitution function into a single integrated closed system. The CSTD components are incorporated directly into the reconstitution pathway, eliminating the need for separate protective measures that would add time to the process.
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 streamlines the reconstitution process, reducing preparation time and error rates, enhancing safety by minimizing exposure to needles and hazardous environments, and allowing for efficient preparation of complex drugs in various settings, including homes and pharmacies.
Implementation Method 1
a pump configured to urge at least a portion of the diluent from the diluent container into the drug product container to at least partially reconstitute the drug product
Data Source
AI summary
Methods of preparing a drug for delivery and drug delivery systems for achieving the same are disclosed. A method of preparing a drug for delivery may include providing a diluent contained in a diluent container and providing a drug product contained within a drug product container. The method may further include fluidly connecting the diluent container and the drug product container. Additionally the method may include urging, via a pump, at least a portion of the diluent from the diluent container into the drug product container to at least partially reconstitute the drug product.