Manifold Needle Actuation for Sterile Drug Compounding
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Solution Overview
Problem
Current pharmaceutical compounding processes lack automation and efficiency, particularly in maintaining sterile conditions and proper mixing characteristics, leading to potential user errors and contamination risks.
Innovation Solution
A compounding system comprising a pump head assembly, magazine, manifold, and pump cartridge that enables closed system diluent and waste paths for reconstitution and delivery of drugs, with a needle assembly that transitions between disengaged and engaged configurations to maintain sterility and prevent air bubbles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compounding is performed by pharmacist or nurse using various tools, then flexibility in creating specific pharmaceutical products is maintained, but sterility maintenance becomes difficult and user error increases
Solution Approach 1:
The system enables self-service compounding where the automated device performs fluid transfer, mixing, and preparation operations without requiring manual intervention by pharmacists or nurses, thereby maintaining sterility while reducing user error
Solution Approach 2:
The patent replaces manual mechanical operations with an automated pump-driven system that uses electronic control to manage fluid pathways, eliminating the need for manual tool handling while maintaining the ability to create specific pharmaceutical formulations
2Productivity
If automated pump system is used to deliver fluid, then delivery speed and precision are improved, but risk of creating air bubbles and improper mixing increases
Solution Approach 1:
The system dynamically adjusts pump operation parameters and fluid delivery rates based on the specific pharmaceutical product being compounded, optimizing both delivery speed and mixing quality while preventing air bubble formation through controlled flow dynamics
Solution Approach 2:
The automated system incorporates feedback mechanisms that monitor fluid transfer and mixing processes, adjusting pump operations in real-time to maintain proper mixing characteristics and prevent air bubble contamination while achieving high delivery speeds
3Ease of operation
If needle assembly is extended from manifold, then fluid pathway is established for drug delivery, but sterility is compromised and air bubbles may be introduced
Solution Approach 1:
The system uses an intermediary sealed connection mechanism between the needle assembly and the receiving container that maintains sterility during fluid transfer, allowing the needle to extend for fluid pathway establishment while preventing contamination through the intermediary seal
4Device complexity
If multiple fluid pathways are integrated in single manifold, then device complexity is reduced, but difficulty in maintaining sealed pathways and preventing contamination increases
Solution Approach 1:
The manifold is designed as a universal multi-functional component that integrates multiple fluid pathways for different pharmaceutical products within a single sealed structure, reducing the number of separate components while maintaining reliable sealing through standardized port designs and integrated valve mechanisms
Data Source
AI summary
A manifold for control of fluid and/or vapor flow between a container and a pump cartridge for a compounder system is provided. One or more manifolds may be disposed in a magazine configured to secure and align the manifolds with a plurality of ports in the cartridge. Each manifold may include a needle having forward and rear openings to a central bore. A needle housing may include a slot configured to receive a push rod for actuating the needle forward and backward. In a forward, engaged position, the openings in the needle may be disposed on opposite sides of a sealing member of the manifold to form a fluid pathway through the manifold. In a rearward, disengaged position, both the forward and rear openings in the needle may be disposed on the same side of the sealing member to prevent fluid and vapor from flowing through the manifold.