Fluid control devices and methods of using the same

Patent metadata

Field	Value
Publication number	US-11857321-B2
Application number	US-202016815526-A
Country	US
Kind code	B2
Filing date	Mar 11, 2020
Priority date	Mar 11, 2019
Publication date	Jan 2, 2024
Grant date	Jan 2, 2024

Abstract

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.

First claim

What is claimed:

1. An apparatus for procuring bodily fluid samples with reduced contamination, the apparatus comprising:
a housing forming a sequestration chamber, the housing having an inlet configured to be fluidically coupled to a bodily fluid source and an outlet configured to be fluidically coupled to a fluid collection device;
an actuator coupled to the housing, the actuator having a first configuration in which the inlet is in fluid communication with the sequestration chamber, and a second configuration in which the inlet is in fluid communication with the outlet and fluidically isolated from the sequestration chamber; and
a flow controller disposed in the sequestration chamber, the flow controller separating a first portion of the sequestration chamber from a second portion of the sequestration chamber, the flow controller having a first state in which the first portion of the sequestration chamber has a first volume and a second state in which the first portion of the sequestration chamber has a second volume greater than the first volume,
the actuator in the first configuration allowing fluid communication between the inlet and the first portion of the sequestration chamber via a first fluid flow path and allowing fluid communication between the outlet and the second portion of the sequestration chamber via a second fluid flow path, the flow controller transitioning from the first state to the second state in response to the suction force being exerted through the second fluid flow path by the fluid collection device, the transitioning of the flow controller operable to draw an initial volume of bodily fluid into the first portion of the sequestration chamber,
the actuator configured to be transitioned to the second configuration after the initial volume of bodily fluid is drawn into the sequestration chamber to (1) sequester the sequestration chamber from the inlet, and (2) fluidically couple a portion of the first fluid flow path to a portion of the second fluid flow path to allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force.

2. The apparatus of claim 1 , wherein the housing includes a first port and a second port, and
the actuator in the first configuration being such that; the first port places the inlet in fluid communication with the first portion of the sequestration chamber and the second port places the outlet in fluid communication with the second portion of the sequestration chamber.

3. The apparatus of claim 1 , wherein the flow controller includes a plurality of deformable portions, and
wherein deformation of each deformable portion from the plurality of deformable portions in response to the suction force transitions the flow controller from the first state to the second state.

4. The apparatus of claim 1 , wherein a cross-sectional area of the first portion of the sequestration chamber in the second state limits mixing of the initial volume of bodily fluid with a volume of air drawn into the first portion of the sequestration chamber.

5. The apparatus of claim 1 , wherein the flow controller has a first deformable portion and a second deformable portion, a first region of the first portion of the sequestration chamber corresponding to the first deformable portion is configured to receive the initial volume of bodily fluid and is configured to receive a volume of air prior to the first portion of the sequestration chamber receiving the initial volume of bodily fluid.

6. The apparatus of claim 5 , wherein the flow controller includes a first deformable portion and a second deformable portion configured to deform in response to the suction force, the first deformable portion is deformed prior to bodily fluid flowing into the first portion of the sequestration chamber, and at least a portion of the second deformable portion is deformed after the first deformable portion is deformed.

7. The apparatus of claim 1 , wherein a first side of the flow controller is in contact with at least a portion of a first surface of the sequestration chamber in the first state and a second side of the flow controller is in contact with at least a portion of a second surface of the sequestration chamber in the second state, the second surface being opposite the first surface.

8. The apparatus of claim 7 , wherein the first state of the flow controller being such that the first surface of the sequestration chamber forms at least one channel configured to allow air flow between the first surface of the sequestration chamber and the first side of the flow controller.

9. The apparatus of claim 7 , wherein the second state of the flow controller being such that the second surface of the sequestration chamber forms at least one ridge configured to allow air flow between the second surface of the sequestration chamber and the second side of the flow controller.

10. The apparatus of claim 7 , wherein the flow controller is a fluid impermeable bladder and the portion of the sequestration chamber is a first portion of the sequestration chamber defined between the first surface of the sequestration chamber and the first side of the fluid impermeable bladder, a second portion of the sequestration chamber is defined between the second surface of the sequestration chamber and the second side of the fluid impermeable bladder.

11. An apparatus for procuring bodily fluid samples with reduced contamination, the apparatus comprising:
a housing forming a sequestration chamber, the housing having an inlet configured to be fluidically coupled to a bodily fluid source and an outlet configured to be fluidically coupled to a fluid collection device;
an actuator coupled to the housing, the actuator having a first configuration in which the inlet is in fluid communication with the sequestration chamber, and a second configuration in which the inlet is in fluid communication with the outlet and fluidically isolated from the sequestration chamber; and
a flow controller disposed in the sequestration chamber, the flow controller having a first state in which a first side of the flow controller is in contact with at least a portion of a first surface of the sequestration chamber and a second state in which a second side of the flow controller is in contact with at least a portion of a second surface of the sequestration chamber, the second surface being opposite the first surface,
the flow controller transitioning from the first state to the second state, as a result of the suction force being exerted on the second side of the flow controller by the fluid collection device to draw an initial volume of bodily fluid into a portion of the sequestration chamber defined between the first surface and the first side of the flow controller,
the actuator configured to be transitioned to the second configuration after the initial volume of bodily fluid is drawn into the portion of the sequestration chamber to (1) sequester the sequestration chamber from the inlet, and (2) fluidically couple a portion of the first fluid flow path to a portion of the second fluid flow path to allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force.

12. The apparatus of claim 11 , wherein the flow controller is a fluid impermeable bladder.

13. The apparatus of claim 11 , wherein the flow controller is a fluid impermeable diaphragm.

14. The apparatus of claim 11 , wherein the portion of the sequestration chamber is a first portion of the sequestration chamber at least partially defined by a first deformable portion of the flow controller, a second portion of the sequestration chamber

Assignees

• Magnolia Medical Technologies Inc

Inventors

• Bullington Gregory J
• Miazga Jay M
• Ramsey Timothy F
• Patterson Abigail

Classifications

• C12M33/04

  by injection or suction, e.g. using pipettes, syringes, needles (pipettes in general B01L3/02) · CPC title

• C12M33/07

  Dosage or metering devices therefore · CPC title

• A61B5/150343 Primary

  Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes (sampling from within body cavities A61B5/150015, A61B5/150045) · CPC title

• A61B5/15003

  for venous or arterial blood · CPC title

• A61B5/150099

  by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes · CPC title