Sterile bodily-fluid collection device and methods

• US 10,251,590 B2
• Filed: 12/04/2013
• Issued: 04/09/2019
• Est. Priority Date: 12/04/2012
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: Bullington, Gregory J., Patton, Richard G., Gaw, Shan E.
• Primary Examiner(s): Dougherty, Sean P
• Assistant Examiner(s): Fernandes, Patrick
• Application Number:
  US14/096,826
• Publication Number:
  US 20140155782A1
• Time in Patent Office: 1,952 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An apparatus includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The diversion mechanism has an inlet port couplable to a lumen-defining device to receive bodily-fluids from a patient, a first outlet port fluidically couplable to the pre-sample reservoir, and a second outlet port fluidically couplable to a sample reservoir. The diversion mechanism defines a first fluid flow path and a second flow path that are configured to place the first outlet port and the second outlet port, respectively, in fluid communication with the inlet port. The flow metering mechanism is configured to meter a flow of a predetermined volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir, to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir, and to display a volumetric indicator associated with the predetermined volume and the second volume.

Claims

1. An apparatus for obtaining a bodily fluid sample from a patient, the apparatus comprising:

a pre-sample reservoir configured to receive a first volume of bodily-fluid withdrawn from the patient;

a diverter including an inlet port, a first outlet port, and a second outlet port, the inlet port configured to be coupled to a lumen-defining device for receiving bodily-fluids from the patient, the first outlet port configured to couple to a first sample reservoir and the second outlet port configured to couple to a second sample reservoir, the diverter defining a first fluid flow path configured to place the pre-sample reservoir in fluid communication with the inlet port and a second fluid flow path configured to place the first outlet port and the second outlet port in fluid communication with the inlet port, the first fluid flow path configured to be fluidically isolated when the second fluid flow path is placed in fluid communication with the inlet port such that contaminants in the first volume of bodily-fluid are sequestered in the pre-sample reservoir;

a first movable member movably coupleable to the diverter and configured to be moved through the first outlet port between a first configuration, in which the first sample reservoir is sequestered from the first outlet port and the second fluid flow path, and a second configuration, in which the first movable member places the first sample reservoir in fluid communication with the second fluid flow path, the second fluid flow path configured to be substantially unobstructed when the first movable member is in the first configuration and when the first movable member is in the second configuration; and

a second movable member movably coupleable to the diverter and configured to be moved through the second outlet port between a first configuration, in which the second sample reservoir is sequestered from the second outlet port and the second fluid flow path, and a second configuration, in which the second movable member places the second sample reservoir in fluid communication with the second fluid flow path, the second fluid flow path configured to be substantially unobstructed when the second movable member is in the first configuration and when the second movable member is in the second configuration.

2. The apparatus of claim 1, wherein the first sample reservoir is configured to receive a second volume of bodily-fluid when the first movable member is in the second configuration, the pre-sample reservoir receiving the first volume of bodily-fluid prior to the first sample reservoir receiving the second volume of bodily-fluid.

3. The apparatus of claim 2, wherein the second sample reservoir is configured to receive a third volume of bodily-fluid when the second movable member is in the second configuration, the pre-sample reservoir receiving the first volume of bodily-fluid prior to the second sample reservoir receiving the third volume of bodily-fluid.

4. The apparatus of claim 1, further comprising:

a flow controller defining a first lumen and a second lumen, the flow controller is configured to be moved between a first configuration in which the first lumen places the first fluid flow path in fluid communication with the inlet port and a second configuration in which the second lumen places the second fluid flow path in fluid communication with the inlet port.

5. The apparatus of claim 4, wherein the flow controller is configured to be moved from the first configuration to the second configuration after the first volume of bodily-fluid is disposed in the pre-sample reservoir.

6. The apparatus of claim 1, wherein the first movable member includes a piercing member configured to pierce a portion of the first sample reservoir when the first movable member is in the second configuration, and

the second movable member includes a piercing member configured to pierce a portion of the second sample reservoir when the second movable member is in the second configuration.

7. The apparatus of claim 3, wherein the first sample reservoir receives the second volume of bodily-fluid prior to the second sample reservoir receiving the third volume of bodily-fluid.

8. The apparatus of claim 4, wherein the flow controller is configured to be rotated relative to the diverter.

9. The apparatus of claim 1, wherein the first sample reservoir includes a seal configured to fluidically isolate the first sample reservoir from the second fluid flow path prior to the first movable member being placed in the second configuration, the first sample reservoir defining a negative pressure operable to transfer bodily-fluid within the second fluid flow path into the first sample reservoir when the first movable member is placed in the second configuration,

the second sample reservoir includes a seal configuration to fluidically isolate the second sample reservoir from the second fluid flow path prior to the second movable member being placed in the second configuration, the second sample reservoir defining a negative pressure operable to transfer bodily-fluid within the second fluid flow path into the second sample reservoir.

10. The apparatus of claim 1, further comprising:

a flow controller coupled to the diverter, the flow controller configured to be transitioned between a first configuration in which the flow controller defines a portion of the first fluid flow path between the inlet port and the pre-sample reservoir, and a second configuration in which the flow controller (1) defines a portion of the second fluid flow path between the inlet port and the first and second outlet ports, and (2) fluidically isolates the first fluid flow path.

11. An apparatus for obtaining a bodily-fluid sample from a patient, the apparatus comprising:

a pre-sample reservoir configured to receive a first volume of bodily-fluid withdrawn from the patient;

a diverter including an inlet port, a first outlet port, and a second outlet port, the inlet port configured to be coupled to a lumen-defining device for receiving bodily-fluids from the patient, the first outlet port configured to fluidically couple the pre-sample reservoir to the diverter and the second outlet port configured to couple a sample reservoir to the diverter;

a flow controller at least partially disposed within the diverter and configured to be moved between a first configuration in which the flow controller defines at least a portion of a first fluid flow path between the inlet port and the first outlet port, and a second configuration in which the flow controller defines at least a portion of a second fluid flow path between the inlet port and the second outlet port, the inlet port being sequestered from the first fluid flow path when the flow controller is in the second configuration such that contaminants in the first volume of bodily-fluid are sequestered in the pre-sample reservoir; and

a movable member movably coupleable to the diverter and configured to be moved through the second outlet port between a first configuration in which the sample reservoir is sequestered from the second outlet port and the second fluid flow path, and a second configuration in which the sample reservoir is in fluid communication with the second fluid flow path, the sample reservoir configured to receive a second volume of bodily-fluid withdrawn from the patient when the flow controller is in the second configuration and the movable member is in the second configuration, the second fluid flow path configured to be substantially unobstructed when the second movable member is in the first configuration and when the second movable member is in the second configuration.

12. The apparatus of claim 11, wherein the flow controller is rotated relative to the diverter between the first configuration and the second configuration.

13. The apparatus of claim 11, wherein the movable member is moved in a linear motion relative to the diverter.

14. The apparatus of claim 11, wherein the movable member includes a piercing member configured to pierce a portion of the sample reservoir when the movable member is in the second configuration.

15. The apparatus of claim 11, wherein the movable member is coupled to a bias member configured to at least temporarily maintain the movable member in the first configuration.

16. The apparatus of claim 11, wherein the sample reservoir includes a seal configured to fluidically isolate the sample reservoir from the second fluid flow path prior to the movable member being placed in the second configuration, the sample reservoir defining a negative pressure operable to transfer bodily-fluid within the second fluid flow path into the sample reservoir when the movable member is placed in the second configuration.

17. An apparatus for obtaining a bodily-fluid sample from a patient, the apparatus comprising:

a pre-sample reservoir configured to receive a first volume of bodily-fluid withdrawn from the patient;

a diverter including a housing and a distribution member, the housing defining a first fluid flow path and a second fluid flow path, the first fluid flow path configured to be in fluid communication with the pre-sample reservoir, the distribution member is at least partially disposed within the housing and defines at least a portion of the second fluid flow path, the distribution member includes a coupling portion in fluid communication with the second fluid flow path and configured to be coupled to a sample reservoir, a portion of the diverter configured to transition between a first configuration in which the sample reservoir is fluidically isolated from the second fluid flow path and a second configuration in which the sample reservoir is in fluid communication with the second fluid flow path, the portion of the diverter configured such that the second fluid flow path is substantially unobstructed when the portion of the diverter is in the first configuration and when the portion of the diverter is in the second configuration; and

a flow controller including an inlet port configured to be in fluid communication with a lumen-defining device for receiving bodily-fluids from the patient, the flow controller coupled to the diverter and configured to be moved between a first configuration in which the inlet port is in fluid communication with the first fluid flow path, and a second configuration in which the inlet port is in fluid communication with the second fluid flow path, the inlet port being fluidically isolated from the first fluid flow path when the flow controller is in the second configuration such that contaminants in the first volume of bodily-fluid are sequestered in the pre-sample reservoir.

18. The apparatus of claim 17, wherein the portion of the diverter includes a piercing member configured to pierce a portion of the sample reservoir to place the sample reservoir in fluid communication with the second fluid flow path.

19. The apparatus of claim 18, wherein the piercing of the portion of the sample reservoir by the piercing member initiates a flow of bodily-fluid from the patient, through the inlet port and the second fluid flow path, and into the sample reservoir when the flow controller is in the second configuration and the portion of the diverter is in the second configuration.

20. The apparatus of claim 17, wherein the first volume of bodily-fluid is a first predetermined volume of bodily-fluid, the second fluid flow path is configured to receive a second predetermined volume of bodily-fluid, the second predetermined volume of bodily-fluid is associated with a sample volume.

21. The apparatus of claim 20, wherein the sample volume is between about 5 milliliters and about 50 milliliters.

22. The apparatus of claim 20, wherein the sample volume is about 30 milliliters.

23. The apparatus of claim 17, wherein the sample reservoir includes a seal configured to fluidically isolate the sample reservoir from the second fluid flow path prior to the portion of the diverter being transitioned to the second configuration, the sample reservoir defining a negative pressure operable to transfer bodily-fluid within the second fluid flow path into the sample reservoir when the portion of the diverter is in the second configuration.