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 describes a bodily-fluid transfer device having a housing with an inlet port configured to be placed in fluid communication with a bodily-fluid source and an outlet port configured to be placed in fluid communication with a sample reservoir. The housing defines at least a portion of a first flow path and a second flow path, and a fluid reservoir disposed in the housing is configured to receive and contain an amount of bodily-fluid withdrawn from the bodily-fluid source. The device operates with configurations that use negative pressure differential to control bodily-fluid movement through the flow paths.

In a first configuration, the first flow path fluidically couples the fluid reservoir to the inlet port such that a negative pressure differential therebetween causes bodily-fluid to flow from the inlet port, through the first flow path, and to the fluid reservoir. A portion of a second flow path between the inlet and the outlet is obstructed to prevent fluid communication that would route bodily-fluid to the outlet port during the first configuration. The device is configured to transition from the first configuration to a second configuration after the fluid reservoir receives an amount of the bodily-fluid.

In a second configuration, the second flow path fluidically couples the outlet port to the inlet port such that a negative pressure differential therebetween causes a subsequent amount of the bodily-fluid to flow from the inlet port, through the second flow path, and to the outlet port. At least part of the amount of the bodily-fluid contained in the fluid reservoir is prevented from flowing from the fluid reservoir to the outlet port, and bodily-fluid flowing through the second flow path bypasses the amount stored in the fluid reservoir.

This arrangement is tied to limiting contamination and reducing false results in culture testing.

Claims Coverage

The independent claims cover a bodily-fluid transfer device using a two-configuration flow-path change driven by negative pressure differential, with an in-housing fluid reservoir and a mechanism to isolate a first received amount while delivering a subsequent amount to an outlet port or sample reservoir.

Across the independent claims, the inventive core is a bodily-fluid transfer device that uses negative pressure differential in two configurations to draw an initial amount into an in-housing fluid reservoir, then transition to a second configuration that drives a subsequent amount through a second flow path to an outlet port while isolating reservoir contents.

Stated Advantages

Documented Applications