Fluid Diversion Mechanism for Contamination-Free Bodily-Fluid Sampling
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Solution Overview
Problem
Existing bodily-fluid sampling methods are prone to contamination from dermally-residing microbes during needle insertion, leading to false positive microbial test results and unnecessary antibiotic treatments.
Innovation Solution
A bodily-fluid transfer device with a housing, fluid reservoir, flow control mechanism, and actuator that isolates a first volume of bodily-fluid in a first reservoir while diverting it to a second reservoir, creating a negative pressure to ensure contamination-free sampling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a needle is inserted into a patient to obtain bodily-fluid samples, then the sample can be obtained for microbial testing, but dermally-residing microbes are dislodged and transferred to the culture medium, causing false positive results
Solution Approach 1:
The patent divides the bodily-fluid collection system into separate reservoirs: a first reservoir for receiving initial fluid and a second reservoir for the diagnostic sample. This segmentation allows the contaminated first volume to be isolated from the diagnostic sample, preventing false positive results while maintaining test accuracy.
Solution Approach 2:
The patent extracts and removes the first volume of bodily-fluid that is likely to contain dermally-residing microbes into a separate first reservoir. By taking out this potentially contaminated portion, the system prevents these microbes from contaminating the diagnostic sample in the second reservoir.
2Device complexity
If the first volume of bodily-fluid is not isolated, then the sampling process is simpler, but the contaminated fluid enters the diagnostic sample causing false positive microbial test results
Solution Approach 1:
The patent segments the sampling system into multiple reservoirs (first reservoir for initial fluid, second reservoir for diagnostic sample) and uses a flow control mechanism with selectable pathways. This segmentation increases device complexity but ensures reliability by preventing contaminated fluid from entering the diagnostic sample.
Solution Approach 2:
The patent introduces a flow control mechanism as an intermediary component that directs fluid flow between the needle, first reservoir, and second reservoir. This intermediary device enables the system to manage and separate the potentially contaminated first volume from the diagnostic sample, ensuring accurate test results.
3Object-affected harmful factors
If a flow control mechanism with multiple reservoirs is used, then microbial contamination is reduced, but the device becomes more complex
Solution Approach 1:
The patent designs the flow control mechanism to perform multiple functions: it controls fluid flow direction, isolates the first volume in the first reservoir, and directs the diagnostic sample to the second reservoir. This multi-functionality reduces the need for separate components, thereby limiting the increase in device complexity while effectively reducing microbial contamination.
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
Reduces microbial contamination by isolating a contaminated first volume of bodily-fluid, preventing it from entering the diagnostic sample, thereby improving test accuracy and reducing unnecessary treatments.
Implementation Method 1
The actuator is configured to create a negative pressure in the fluid reservoir when actuated by a user
Data Source
AI summary
An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.