Fluid diversion mechanism for bodily-fluid sampling

Inventors

Bullington, Gregory J. • Patton, Richard G. • Miazga, Jay M. • Gaw, Shan E.

Assignees

Magnolia Medical Technologies Ltd

Abstract

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.

Core Innovation

The invention provides a bodily-fluid transfer device with a housing including an inlet port and an outlet port, where the inlet port is configured to be fluidically coupled to a bodily-fluid source and the outlet port is configured to be fluidically coupled to a sample reservoir. The housing disposes a fluid reservoir disposed in the housing and at least partially defined by the housing, the fluid reservoir configured to receive and sequester a first amount of bodily-fluid withdrawn from the bodily-fluid source.

The device includes a flow controller disposed in an inner volume of the housing, forming a friction fit with an inner surface defining at least a portion of the inner volume. The flow controller transitions between a first configuration and a second configuration to change fluid communication pathways, and is configured to automatically transition from the first configuration to the second configuration after the first amount flows into or is at least partially disposed in the fluid reservoir.

In the first configuration, the inlet port is in fluid communication with the fluid reservoir to facilitate flow of the first amount from the inlet port through a first fluid flow path to the fluid reservoir. In the second configuration, the inlet port is in fluid communication with the outlet port to facilitate flow of a second amount from the inlet port through a second fluid flow path to the outlet port or via a sampling path.

In further embodiments, the device includes a seal member at least partially disposed in the housing to at least partially define the fluid reservoir, where the seal member is characterized as forming a substantially fluid-tight seal with at least a portion of the inner surface of the housing. The seal member and flow-control configurations enable fluidic isolation of the outlet port from the fluid reservoir when the flow controller is in the second configuration, and a negative pressure differential is enabled so that a first amount flows from the inlet port into the fluid reservoir.

Claims Coverage

The independent claims cover a bodily-fluid transfer device with a friction-fit flow controller that automatically switches fluid communication after a first amount is disposed in a fluid reservoir. The main inventive features described across the independent claims are: (1) a friction-fit flow controller that transitions between first and second configurations, (2) automatic transition after the first amount flows into or is at least partially disposed in the fluid reservoir, and (3) seal-member-defined reservoir behavior including negative pressure differential and outlet isolation in the second configuration.

Across the independent claims, the core claim coverage centers on a friction-fit flow controller that switches between first and second configurations to route a first amount into a fluid reservoir and then route a second amount to an outlet port, with automatic transition tied to the disposition of the first amount in the reservoir. Additional embodiments include a seal member that at least partially defines the reservoir, enabling substantially fluid-tight sealing, outlet-side fluidic isolation in the second configuration, and negative pressure differential enabled intake.

Stated Advantages

Documented Applications