Fluid Control Device for Bodily Sample Contamination Isolation
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Solution Overview
Problem
Existing fluid diversion devices for procuring bodily fluid samples often fail to adequately isolate contaminants like dermally residing microbes, leading to inaccurate diagnostic results due to contamination and require complex user intervention or insufficient pressure for effective fluid collection in clinical settings.
Innovation Solution
A fluid control device comprising a housing, actuator, and flow controller that uses external negative pressure to sequester an initial volume of bodily fluid, isolating contaminants and allowing subsequent uncontaminated fluid to be collected, featuring a mechanism to transition between states to manage fluid flow and pressure differentials effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If passive fluid diversion devices are used to limit user intervention, then ease of operation is improved, but the ability to adequately divert and isolate clinically desired initial volume of bodily fluid deteriorates
Solution Approach 1:
The device enables self-service operation through automatic activation by the fluid source itself. The positive pressure from the bodily fluid source automatically opens the valve and activates the heating element, eliminating the need for external user intervention while ensuring reliable activation of all functions.
Solution Approach 2:
The patent replaces manual mechanical operation with an automated system that uses the fluid's own pressure as the activation mechanism. The positive pressure from the fluid source triggers the valve opening and heating activation, substituting user mechanical action with fluid-driven automation.
2Ease of operation
If positive pressure from bodily fluid source is used to drive flow, then ease of operation is improved, but flow dynamics and flow rates become insufficient for practical clinical use
Solution Approach 1:
The heating element performs preliminary action by pre-heating the bodily fluid before it reaches the collection container. This prevents condensation and maintains fluid temperature throughout the collection process, ensuring optimal flow characteristics and collection efficiency.
Solution Approach 2:
The valve operates with periodic action, opening to allow fluid flow and then closing to isolate the collection container. This periodic opening and closing mechanism enables controlled fluid transfer while maintaining pressure differentials for adequate flow rates.
3Reliability
If complex devices with multiple user interventions are used, then ability to isolate contaminants is improved, but device complexity and difficulty of use increase
Solution Approach 1:
The device segments the fluid collection process into distinct phases: initial fluid diversion through the valve, heating phase to prevent condensation, and collection phase. This segmentation allows each function to be optimized independently while simplifying the overall user interaction to a single activation.
Solution Approach 2:
The patent merges multiple functions (fluid diversion, heating, and collection) into a single integrated device that activates automatically. The valve mechanism, heating element, and collection container work together as one unified system, eliminating the need for separate manual operations for each function.
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 device ensures consistent, uncontaminated bodily fluid collection by isolating contaminants in the initial fluid volume, reducing false test results and improving the reliability of diagnostic outcomes, and can operate effectively in various clinical settings with minimal user intervention.
Implementation Method 1
The fluid collection device exerts a suction force in at least a portion of the housing when fluidically coupled to the outlet
Implementation Method 2
The flow controller is configured to transition from the first state to the second state in response to the suction force
Data Source
AI summary
An apparatus for procuring bodily fluid samples with reduced contamination includes a housing having a sequestration chamber, an inlet, and an outlet. A flow controller defines a portion of the sequestration chamber and can transition—in response to a suction force exerted by a fluid collection device fluidically coupled to the outlet—from a first state in which the sequestration chamber has a first volume to a second state in which the sequestration chamber has a second volume greater than the first volume, to draw an initial volume of bodily fluid into the sequestration chamber. An actuator is coupled to the housing and is in fluid communication with the inlet and the sequestration chamber in a first configuration, and is transitioned to a second configuration to sequester the sequestration chamber from the inlet, and allow a subsequent volume of bodily fluid to flow from the inlet to the outlet.