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-11903710-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
A fluid control device is described having a housing with an inlet fluidically coupleable to a blood source and an outlet fluidically coupleable to a fluid collection device. The housing defines at least a portion of a containment channel and a sampling channel between the inlet and the outlet, and includes a selectively permeable blood barrier fluidically coupled to the containment channel and the outlet.
The blood barrier is configured to allow 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. An actuator disposed at least partially in the housing substantially obstructs 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 blood barrier allows pressure in at least a portion of the sampling channel between the actuator and the outlet to build sufficiently to transition the actuator from the first state to a second state. In the second state, the actuator prevents the initial volume from being released to the outlet and allows subsequent blood flow through the sampling channel to the outlet while at least a portion remains in the containment channel.
Claims Coverage
The independent claims are clm-00001, clm-00009, clm-00017, and clm-00025. They center on a housing with containment and sampling channels, a selectively permeable blood barrier that allows gas flow in response to pressure differentials to draw blood into the containment channel, and an actuator that transitions from a first state to a second state to control subsequent blood flow.
Housing with containment channel and sampling channel
A housing having an inlet fluidically coupleable to a blood source and an outlet fluidically coupleable to 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.
Selectively permeable blood barrier for gas flow in response to pressure differential
A selectively permeable blood barrier fluidically coupled to the containment channel and the outlet, configured to allow 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.
Actuator obstructing flow path and transitioning due to pressure differential build
An actuator disposed at least partially in the housing and configured to substantially obstruct a flow path between the inlet and the outlet when in a first state, and to transition from the first state to a second state in response to contact with at least a portion of the volume of blood in the containment channel and a resulting increase in pressure differential in at least a portion of the sampling channel between the actuator and the outlet.
Threshold-based actuator transition
The actuator configured to transition from a first state to a second state in response to a pressure differential in at least a portion of the sampling channel between the actuator and the outlet exceeding a threshold pressure, or in response to a second pressure differential greater than the first pressure differential.
Across the independent claims, the device defines containment and sampling channels, uses a selectively permeable blood barrier to draw blood into the containment channel, and uses an actuator that blocks flow in a first state and then transitions to allow subsequent blood flow to the outlet in a second state.
Stated Advantages
Reduced contaminants by sequestering an initial or pre-sample volume and subsequently drawing blood through the outlet substantially free of contaminants.
Automatic transition of operating modes without manual intervention.
Documented Applications
Bodily-fluid sample fluid-control for receiving and sequestering an initial bodily-fluid volume and transferring subsequent bodily fluid volume to a collection device.
Improving sample integrity for downstream microbial culture and non-culture diagnostics including microbial testing and diagnostics identified as PCR and NGS.
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