ECC Connector Assembly with Closure Mechanisms
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Solution Overview
Problem
Existing extra-corporeal circuit (ECC) systems lack effective methods for safely introducing, removing, or replacing purification components without risking blood loss, air intake, or contamination during continuous operation, posing dangers to patients.
Innovation Solution
The development of a connector assembly with multiple closure mechanisms that allow for safe modification and replacement of components within ECC systems, such as ECMO, by obstructing fluid flow through a tubular body with pinch clamps and turn valves, enabling continuous operation during component swaps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of repair
If purification components are introduced, removed, or replaced in existing ECC systems, then component maintenance and upgrades can be performed, but blood loss, air intake, or contamination risks increase dangerously
Solution Approach 1:
The closure mechanisms are actuated to close off the lumen before the purification component is disconnected, preventing blood loss and contamination during the replacement process. This preliminary closure action ensures patient safety is maintained throughout the component swap operation.
Solution Approach 2:
The closure mechanisms serve as intermediary elements between the fluid pathway and the external environment during component replacement. These mechanisms mediate the transition state, maintaining system integrity and preventing harmful factors like air intake and contamination while allowing component removal.
2Reliability
If closure mechanisms are used to obstruct fluid flow during component replacement, then patient safety is maintained, but device complexity increases
Solution Approach 1:
The closure mechanism is divided into separate functional elements: a closure element that obstructs the lumen and an actuator that controls its position. This segmentation allows for simplified manufacturing and easier integration into the connector assembly while maintaining the safety function.
Solution Approach 2:
The closure mechanism is designed to be actuated by the connector assembly itself during the component replacement process, eliminating the need for external complex control systems. The mechanism serves the safety function autonomously as part of the connector assembly operation.
3Adaptability or versatility
If existing purification components are used, then basic purification function is provided, but they cannot be safely replaced during continuous operation
Solution Approach 1:
The closure mechanisms are actuated to close off the lumen before the purification component is disconnected, preventing blood loss and contamination during the replacement process. This preliminary closure action ensures patient safety is maintained throughout the component swap operation.
Solution Approach 2:
The ECC system continues to operate continuously during the purification component replacement process. The closure mechanisms enable component swap without interrupting the overall system function, maintaining continuous blood purification and oxygenation support for the patient.
Data Source
AI summary
Connector assemblies and methods of replacing components in an extra-corporeal circuit (ECC) system are disclosed. A connector assembly for use in an ECC system includes a tubular body having an inner surface defining a lumen extending through the tubular body with the lumen extending along a longitudinal axis, a first connection interface in fluid communication with the lumen, a second connection interface in fluid communication with the lumen, and a plurality of closure mechanisms, each closure mechanism being configured to occlude the lumen.