Fluid control devices and methods of using the same
Inventors
Bullington, Gregory J. • Miazga, Jay M. • Gaw, Shan E. • RAMSEY, Timothy F.
Assignees
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Publication Number
US-11903709-B2
Publication Date
2024-02-20
Expiration Date
Abstract
A fluid control device includes an inlet configured to be placed directly or indirectly in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. The fluid control device has a first state in which a negative pressure differential produced from an external source such as the fluid collection device is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source, through the inlet, and into a sequestration portion of the fluid control device. The fluid control device has a second state in which (1) the sequestration portion sequesters the initial volume, and (2) the negative pressure differential draws a subsequent volume of bodily fluid, being substantially free of contaminants, from the bodily fluid source, through the fluid control device, and into the fluid collection device.
Core Innovation
The invention relates to a fluid control device for bodily-fluid sampling that includes a housing defining at least a portion of a containment channel and a sampling channel between an inlet and an outlet. The housing is fluidically coupleable to a blood source and to a fluid collection device, and the containment channel receives an initial volume of blood.
A selectively permeable blood barrier is fluidically coupled to the containment channel and the outlet and is configured to allow a gas to flow through the blood barrier in response to a pressure differential between the inlet and the outlet, thereby allowing a volume of blood to flow into the containment channel. A valve disposed at least partially in the housing is configured to substantially obstruct a flow path between the inlet and the outlet when in a first state.
In response to contact with at least a portion of the volume of blood in the containment channel, the pressure differential in at least a portion of the sampling channel between the valve and the outlet builds to an extent sufficient to transition the valve from the first state to a second state. In the second state, the valve allows blood to flow through the sampling channel to the outlet, enabling subsequent fluid collection following initial sequestration.
The device architecture includes modular and integrated fluid control device configurations and is intended to sequester an initial pre-sample volume before diverting subsequent contaminant-reduced fluid to a collection device. The document describes valve and pressure modulation via a selectively permeable blood barrier, restricted flow path and/or dampening chamber concepts, and separable housing and reconfigurable sequestration chamber arrangements.
Claims Coverage
The partial content identifies four independent claims directed to a fluid control device that uses a selectively permeable blood barrier to drive initial blood into a containment channel and a valve that transitions from a first state to a second state to allow subsequent blood flow to an outlet.
Housing with containment and sampling channels
A housing fluidically coupleable to a blood source and a fluid collection device, the housing defining at least a portion of each of a containment channel and a sampling channel between the inlet and the outlet.
Selective gas-permeable blood barrier for containment channel loading
A selectively permeable blood barrier fluidically coupled to the containment channel and the outlet and configured to allow a gas to flow through the blood barrier in response to a pressure differential between the inlet and the outlet, thereby allowing a volume of blood to flow into the containment channel.
Valve obstructing flow in a first state
A valve disposed at least partially in the housing and configured to substantially obstruct or prevent a flow path between the inlet and the outlet, or prevent blood from flowing from the inlet to the outlet via the sampling channel, when in a first state.
Pressure-differential-triggered transition to allow sampling-channel flow
A pressure differential in at least a portion of the sampling channel between the valve and the outlet builds, increases, or exceeds a threshold as a result of the volume of blood in the containment channel, thereby transitioning the valve from the first state to a second state in which the valve allows blood to flow through the sampling channel to the outlet.
Across the independent claims, the inventive concept centers on a housing defining containment and sampling channels, a selectively permeable blood barrier that permits gas flow in response to an inlet-to-outlet pressure differential to load blood into the containment channel, and a valve that prevents initial sampling-channel flow and then transitions to allow subsequent blood flow to the outlet when sampling-channel pressure increases or exceeds a threshold.
Stated Advantages
Sequesters an initial pre-sample volume to reduce contaminants, thereby reducing false results in a diagnostic workflow.
Documented Applications
Diagnostic workflows including culture and molecular diagnostics such as PCR and NGS, with emphasis on reduced false results via contaminant sequestration.
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