Medical Device Valve Activation for Dose Preparation
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Solution Overview
Problem
There is a need to improve the process for preparing doses of cell-based formulated drug products, specifically to ensure consistent volume and cell concentration while minimizing contamination risks in various environments.
Innovation Solution
A medical device system comprising a first container with a valve that activates upon connection to a second container, allowing for controlled flow and minimizing contamination risks, while also incorporating a sheath and plunger seal for precise volume control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a valve is activated upon connection to control flow, then manufacturing precision of dose volume is improved, but device complexity increases
Solution Approach 1:
The valve system is designed to activate automatically upon connection between containers, using the connection force itself to open the valve without requiring separate activation mechanisms. The plunger seal moves with the connecting plunger to automatically open the valve, and the system self-regulates flow based on pressure differentials and connection geometry.
Solution Approach 2:
The valve is pre-configured in a closed position before connection, ensuring that flow control is already in place before the actual connection occurs. The plunger seal is positioned to block the flow path in advance, and the valve mechanism is prepared to open automatically when the connection force is applied.
2Ease of operation
If connection between containers is simplified, then ease of operation is improved, but contamination risk increases
Solution Approach 1:
The valve is pre-configured in a closed position before connection, ensuring that flow control is already in place before the actual connection occurs. The plunger seal is positioned to block the flow path in advance, and the valve mechanism is prepared to open automatically when the connection force is applied.
Solution Approach 2:
The plunger seal acts as an intermediary element between the two containers during connection. It maintains the closed state during the connection process itself, and only allows flow after the connection is properly established and the seal has moved to the open position, thus mediating between the need for simple connection and contamination prevention.
3Manufacturing precision
If flow control is enhanced through valve activation, then manufacturing precision of cell concentration is improved, but device complexity increases
Solution Approach 1:
The flow control system uses the pressure differential created during connection and the geometry of the plunger seal movement to automatically regulate flow rate. The valve opens to the extent needed based on the connection force and pressure conditions, self-regulating the flow without requiring external control mechanisms.
Solution Approach 2:
The system uses fluid pressure differentials between the two containers to drive the valve opening and control the flow rate. The pressure gradient created during connection automatically opens the valve to the appropriate degree, using hydraulic principles to achieve precise flow control without mechanical complexity.
Data Source
AI summary
A medical device system including a first container and a second container, the first container including a first container outer body defining a first interior space connected to a first opening of the first container; and a first container-side valve configured to be activated, upon connection of the second container to the first container, from a normally closed position into the first interior space to an activated position, and the second container including a second container outer body defining a second container interior space and a stem fluidly connected to the second container interior space, wherein, upon connection of the second container to the first container, the first container-side valve is configured to be brought into contact with the stem and the stem is configured to activate the first container-side valve from the normally closed position to the activated position.