Closed Blood Transfer Device With Unidirectional Waste Diversion
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Solution Overview
Problem
Existing blood collection systems lead to approximately 40% false-positive blood culture tests due to blood contamination during collection, which are costly and difficult to use, leading to human error and inefficiency.
Innovation Solution
A closed blood transfer device with a unidirectional valve and a system comprising a needle, tubing, and a tube holder with a selectively rupturable shroud, ensuring controlled blood diversion and sample collection, minimizing contamination and human error.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If selective valves and stopcocks are used for blood diversion, then blood flow control is achieved, but device complexity and ease of operation deteriorate
Solution Approach 1:
The patent removes complex selective valves and stopcocks from the blood collection system, extracting only the essential blood diversion function while eliminating unnecessary components. The system uses simple gravity-driven flow and unidirectional valves instead of complex mechanical control mechanisms, thereby reducing device complexity while maintaining reliable blood flow control.
Solution Approach 2:
The blood diversion system operates automatically based on gravity and pressure differentials without requiring manual valve adjustment. The unidirectional valves and open/closed configurations self-regulate blood flow direction, eliminating the need for operator intervention in complex valve operations and improving ease of use.
2Device complexity
If manual blood diversion is used, then device complexity is reduced, but human error and contamination risk increase
Solution Approach 1:
The system incorporates unidirectional valves that provide automatic feedback on blood flow direction. The valves only allow blood to flow in the correct direction toward the collection vial, preventing backflow and contamination without requiring manual control. This automatic feedback mechanism reduces human error while maintaining simplicity.
Solution Approach 2:
The patent introduces unidirectional valves as intermediary components that mediate blood flow between the collection site and the vial. These simple valves act as automated guards against contamination, filtering out the need for complex manual diversion mechanisms while ensuring reliable sterile collection.
3Reliability
If waste blood is drawn and sequestered, then false-positive tests are reduced, but loss of time and productivity decrease
Solution Approach 1:
The system performs preliminary blood withdrawal and sequestration automatically as part of the standard collection protocol. The unidirectional valve system is pre-configured to direct waste blood away from the vial, and the entire process is designed to complete the waste blood sequestration step efficiently without requiring additional manual intervention or extending collection time.
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 reduces contamination risks, minimizes blood loss, and enhances the accuracy of blood culture tests by simplifying the blood diversion process and ensuring sterility.
Implementation Method 1
The connector includes an outlet in fluidic communication with a unidirectional valve that allows fluid to pass in one direction toward an associated syringe
Implementation Method 2
the valve consists of a hydrophilic material that allows fluid to be transferred therethrough for a predetermined time before it seals
Implementation Method 3
The tube holder includes a needle designed to puncture the blood culture collection means
Implementation Method 4
the needle is surrounded by a sheath, thereby closing the system before the needle pierces the collection means
Data Source
AI summary
A blood sequestration system is provided that does not employ a mechanical means for selectively directing waste blood to a sample collection bottle, such as a blood culture bottle. The system employs a syringe to collect waste blood, wherein the syringe creates a negative pressure that actuates a one-way valve that prevents collected blood from being directed toward the sample collection bottle. After a predetermined amount of waste blood is collected, the sample collection bottle is selectively opened to receive sample blood, wherein the waste blood is prevented from tainting the sample blood.