Fluid diversion mechanism for bodily-fluid sampling

• US 10,039,483 B2
• Filed: 12/05/2017
• Issued: 08/07/2018
• Est. Priority Date: 10/13/2011
• 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): EISEMAN, ADAM JARED
• Application Number:
  US15/832,091
• Publication Number:
  US 20180092584A1
• Time in Patent Office: 245 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 10/0048 for taking amniotic fluid samples
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2010/0061 Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
• CPC Class Codes: A61B 2010/0077 Cerebrospinal fluid
• 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 5/150206 Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146

Abstract

An apparatus includes a housing, a flow control mechanism, and an actuator. At least a portion of the flow control mechanism is movably disposed within the housing. The apparatus further includes an inlet port and an outlet port, and defines a fluid reservoir. The outlet port is fluidically coupled to a second fluid reservoir and is fluidically isolated from the first fluid reservoir. The actuator is configured to move the flow control mechanism between a first configuration, in which the inlet port is placed in fluid communication with the fluid reservoir such that the fluid reservoir receives a first flow of bodily-fluid, and a second configuration, in which the inlet port is placed in fluid communication with the outlet port.

Claims

1. A blood sequestration device, comprising:

a housing having an inlet port configured to be fluidically coupled to a patient and an outlet port configured to be fluidically coupled to a sample reservoir;

a fluid reservoir disposed in the housing and at least partially defined by a seal member, the fluid reservoir configured to receive an initial volume of blood withdrawn from the patient; and

a vent disposed in the housing and configured to allow air to exit the housing as blood enters the fluid reservoir,

the blood sequestration device configured to allow the initial volume of blood to flow from the inlet port to the fluid reservoir,

the blood sequestration device further configured to allow a subsequent volume of blood to flow from the inlet port toward the outlet port via a sampling flow path, thereby bypassing the fluid reservoir and the initial volume of blood sequestered therein.

2. The blood sequestration device of claim 1, wherein the initial volume of blood is less than approximately 5 ml.

3. The blood sequestration device of claim 1, wherein the initial volume of blood is less than approximately 0.5 ml.

4. The blood sequestration device of claim 1, wherein the initial volume of blood is approximately 0.1 ml to approximately 0.5 ml.

5. The blood sequestration device of claim 1, wherein the outlet port is fluidically isolated from the fluid reservoir.

6. The blood sequestration device of claim 1, wherein the seal member is configured to prevent the flow of air through the vent into the fluid reservoir.

7. The blood sequestration device of claim 1, wherein the initial volume of blood is fluidically isolated in the fluid reservoir.

8. The blood sequestration device of claim 1, wherein the blood sequestration device is configured to automatically transition from a first operating mode in which the initial volume of blood is allowed to flow from the inlet port to the fluid reservoir, to a second operating mode in which the subsequent volume of blood is allowed to flow from the inlet port toward the outlet port via the sampling flow path.

9. A blood sequestration device, comprising:

a housing having an inlet port configured to be fluidically coupled to a patient and an outlet port configured to be fluidically coupled to a sample reservoir;

a first fluid flow path disposed in the housing and configured to allow an initial volume of blood to flow from the inlet port to a fluid reservoir defined at least partially by the housing;

a vent disposed in the housing and configured to allow air to exit the housing as blood enters the fluid reservoir; and

a second fluid flow path disposed in the housing and configured to allow a subsequent volume of blood to flow from the inlet port toward the outlet port;

the blood sequestration device configured to transition from a first operating mode in which the initial volume of blood is allowed to flow from the inlet port to the fluid reservoir via the first fluid flow path, to a second operating mode in which the subsequent volume of blood is allowed to flow from the inlet port toward the outlet port via the second fluid flow path, thereby bypassing the fluid reservoir and the initial volume of blood sequestered therein.

10. The blood sequestration device of claim 9, wherein the initial volume of blood is less than approximately 5 ml.

11. The blood sequestration device of claim 9, wherein the initial volume of blood is less than approximately 0.5 ml.

12. The blood sequestration device of claim 9, wherein the initial volume of blood is approximately 0.1 ml to approximately 0.5 ml.

13. The blood sequestration device of claim 9, wherein the outlet port is fluidically isolated from the fluid reservoir.

14. The blood sequestration device of claim 9, wherein the initial volume of blood is fluidically isolated in the fluid reservoir.

15. The blood sequestration device of claim 9, wherein the fluid reservoir is at least partially defined by a seal member disposed in the housing.

16. The blood sequestration device of claim 15, wherein the seal member is configured to prevent the flow of air through the vent into the fluid reservoir.

17. The blood sequestration device of claim 9, wherein the blood sequestration device is configured to transition from the first operating mode to the second operating mode without manual intervention.

18. A blood sequestration device, comprising:

a lumen-containing device configured to be fluidically coupled to a patient;

a housing having an inlet port configured to be fluidically coupled to the lumen-containing device, and an outlet port configured to be fluidically coupled to a sample reservoir;

a reservoir at least partially defined by the housing, the reservoir configured to receive an initial volume of blood withdrawn from the patient; and

a vent disposed in the housing and configured to allow air to exit the housing as blood enters the reservoir,

the reservoir configured to transition from a first state such that the initial volume of blood flows from the inlet port toward a seal defining a portion of the reservoir, to a second state such that a subsequent volume of blood can flow from the inlet port toward the outlet port, thereby bypassing the reservoir and the initial volume of blood sequestered therein.

19. The blood sequestration device of claim 18, wherein the initial volume of blood is less than approximately 5 ml.

20. The blood sequestration device of claim 18, wherein the initial volume of blood is less than approximately 0.5 ml.

21. The blood sequestration device of claim 18, wherein the initial volume of blood is approximately 0.1 ml to approximately 0.5 ml.

22. The blood sequestration device of claim 18, wherein the seal is configured to prevent the flow of air through the vent into the reservoir.

23. The blood sequestration device of claim 18, wherein the initial volume of blood is fluidically isolated in the reservoir.

24. A blood sequestration device, comprising:

a lumen-containing device configured to be fluidically coupled to a patient; and

a housing having an inlet port configured to be fluidically coupled to the lumen-containing device, and an outlet port configured to be fluidically coupled to a sample reservoir,

the housing defining a first fluid flow path and a second fluid flow path, the housing configured to transition from a first operating mode in which an initial volume of blood is allowed to flow from the inlet port toward a seal via the first fluid flow path, to a second operating mode in which a subsequent volume of blood is allowed to flow from the inlet port toward the outlet port via the second fluid flow path,

the housing including a vent configured to allow air to exit the housing as blood enters the first fluid flow path,

the seal configured to transition from a first state to a second state to place the housing in the second operating mode such that the subsequent volume of blood can flow toward the outlet port via the second fluid flow path and bypass the initial volume of blood sequestered in the first fluid flow path.

25. The blood sequestration device of claim 24, wherein the initial volume of blood is less than approximately 5 ml.

26. The blood sequestration device of claim 24, wherein the initial volume of blood is less than approximately 0.5 ml.

27. The blood sequestration device of claim 24, wherein the initial volume of blood is approximately 0.1 ml to approximately 0.5 ml.

28. The blood sequestration device of claim 24, wherein the initial volume of blood is fluidically isolated in the first fluid flow path.