Fluid diversion mechanism for bodily-fluid sampling

• US 9,204,864 B2
• Filed: 07/29/2013
• Issued: 12/08/2015
• Est. Priority Date: 08/01/2012
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: Bullington, Gregory J., Patton, Richard G., Miazga, Jay M, Gaw, Shan E.
• Primary Examiner(s): Henson, Devin
• Assistant Examiner(s): McCrosky, David J
• Application Number:
  US13/952,964
• Publication Number:
  US 20140039348A1
• Time in Patent Office: 862 Days
• Field of Search: 600576-584, 604246-249, 738/645.2, 141/8, 141/65
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means

Abstract

A device includes a pre-sample reservoir, an actuator mechanism, and a diverter. The pre-sample reservoir can be fluidically coupled to a delivery member to receive and isolate a predetermined volume of bodily-fluid withdrawn from a patient. The actuator mechanism is operably coupled to the pre-sample reservoir such that, when actuated, a negative pressure is formed in the pre-sample reservoir that urges the bodily-fluid to flow into the pre-sample reservoir. The diverter can selectively control fluid flow between the delivery member and the pre-sample reservoir. The diverter includes a flow control mechanism that defines a first fluid flow path and a second fluid flow path. The diverter is movable between a first configuration in which the bodily-fluid flows through the first fluid flow path to the pre-sample reservoir, and a second configuration in which the bodily-fluid flows through the second fluid flow path to a sample reservoir coupled to the diverter.

Claims

1. A device for parenterally-procuring bodily-fluid samples with reduced contamination from a patient, the device comprising:

a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween;

a pre-sample reservoir disposed in the inner volume of the housing and configured to receive and isolate a first volume of bodily-fluid withdrawn from the patient;

an actuator mechanism movably coupled to the housing and at least partially defining a portion of the pre-sample reservoir, the actuator mechanism configured to form a negative pressure in the pre-sample reservoir when actuated by a user to urge the first volume of bodily-fluid to flow into the pre-sample reservoir;

a diverter at least partially disposed in the inner volume and movably coupled to the actuator mechanism, the diverter having an inlet port configured to be fluidically coupled to the patient, and an outlet port configured to be fluidically coupled to a sample reservoir, the diverter configured to selectively control fluid flow between the inlet port and the pre-sample reservoir, the diverter defining a first fluid flow path and a second fluid flow path; and

a flow control mechanism slidably coupled to the diverter and defining the inlet port, the flow control mechanism configured to be moved between a first configuration such that the first volume of bodily-fluid flows through the first flow path to the pre-sample reservoir, and a second configuration such that a second volume of bodily-fluid flows through the second flow path to the outlet port.

2. The device of claim 1, wherein the diverter fluidically isolates the pre-sample reservoir from the second flow path.

3. The device of claim 1, wherein the actuator mechanism is configured to be moved between a first configuration and a second configuration to automatically move the flow control mechanism from its first configuration to its second configuration.

4. The device of claim 1, wherein the actuator mechanism includes a lever coupled to a plunger, the lever configured to be moved from a first position to a second position to move the plunger between a first position and a second position to create the negative pressure in the pre-sample reservoir.

5. The device of claim 4, wherein the lever is pivotally coupled to the plunger.

6. The device of claim 4, wherein a surface of the plunger defines at least a portion of the pre-sample reservoir.

7. The device of claim 1, wherein the diverter includes a locking mechanism configured to at least temporarily lock the flow control mechanism in the second configuration once the flow control mechanism has been moved from the first configuration to the second configuration.

8. A bodily-fluid sampling device, comprising:

a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween;

a pre-sample reservoir at least partially defined by the housing and configured to be fluidically coupled to a delivery member, the pre-sample reservoir configured to receive and isolate a predetermined volume of bodily-fluid withdrawn from a patient, via the delivery member;

a diverter mechanism at least partially disposed in the inner volume and configured to be fluidically coupled to the pre-sample reservoir, the diverter mechanism including a flow control mechanism configured to be moved between a first configuration in which the flow control mechanism and a first portion of the diverter mechanism collectively define a first fluid flow path between the delivery member and the pre-sample reservoir and a second configuration in which the flow control mechanism and a second portion of the diverter mechanism collectively define a second fluid flow path between the delivery member and a sample reservoir operably coupled to the diverter mechanism; and

an actuator operably coupled to the diverter mechanism and at least partially defining a portion of the pre-sample reservoir, the actuator configured to be moved from a first position when the flow control mechanism is in the first configuration, to a second position, to form a negative pressure in the pre-sample reservoir.

9. The device of claim 8, wherein the actuator includes a lever and a plunger, the lever configured to be moved from a first position to a second position to move the plunger between a first position and a second position to create the negative pressure in the pre-sample reservoir.

10. The device of claim 8, wherein the actuator is configured to automatically move the flow control mechanism from its first configuration to its second configuration.

11. The device of claim 8, wherein the actuator includes a lever coupled to a plunger, the lever configured to be moved from a first position to a second position to move the plunger between a first position and a second position to create the negative pressure in the pre-sample reservoir.

12. The device of claim 11, wherein the lever is pivotally coupled to the plunger.

13. The device of claim 11, wherein a surface of the plunger defines at least a portion of the pre-sample reservoir.