Syringe-based fluid diversion mechanism for bodily fluid sampling

• US 10,206,613 B2
• Filed: 10/12/2015
• Issued: 02/19/2019
• Est. Priority Date: 11/30/2012
• 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): Hindenburg, Max
• Application Number:
  US14/880,397
• Publication Number:
  US 20160135724A1
• Time in Patent Office: 1,226 Days
• Field of Search: 600575- 9
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 5/1405 Devices for taking blood samples devices for taking samples of other body liquids A61B10/0045
• CPC Class Codes: A61B 5/1416 by syringes containing more than one piston medical syringes in general A61M5/178
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/1438 using pre-evacuated means
• 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 5/150251 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 5/150343 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 Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• 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
• 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: B01L 3/0231 having several coaxial pistons

Abstract

A syringe-based device includes a housing, a pre-sample reservoir, and an actuator. The housing defines an inner volume between a substantially open proximal end portion and a distal end portion that includes a port couplable to a lumen-defining device. The pre-sample reservoir is fluidically couplable to the port to receive and isolate a first volume of bodily fluid. The actuator is at least partially disposed in the inner volume and has a proximal end portion that includes an engagement portion and a distal end portion that includes a sealing member. The engagement portion is configured to allow a user to selectively move the actuator between a first configuration such that bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration such that bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing.

Claims

1. A method of sequestering bodily fluid withdrawn from a patient with a bodily fluid sequestration device, the method comprising:

establishing fluid communication between the patient and a channel of the bodily fluid sequestration device via a port, the channel defining a first fluid flow path and including a valve configured to form a substantially fluid tight seal with walls defining the channel;

the valve being operative to move from a closed configuration to an open configuration in response to a difference in pressure between a valve inlet and a valve outlet,

the valve being further operative to return to the closed configuration in response to equalization of pressure between the valve inlet and the valve outlet;

receiving an initial volume of bodily fluid from the patient into the bodily fluid sequestration device via the port and the first fluid flow path, the first fluid flow path extending from a proximal end of the port when the initial volume of bodily fluid is received;

sequestering the initial volume of bodily fluid;

after the initial volume of bodily fluid is sequestered, receiving a subsequent volume of bodily fluid from the patient into a second fluid flow path of the bodily fluid sequestration device, at least a portion of the second fluid flow path formed separately from the first fluid flow path; and

providing via the second fluid flow path a volume of bodily fluid with reduced contamination due to the sequestration of the initial volume of bodily fluid.

2. The method of claim 1, wherein the valve is a one-way check valve.

3. The method of claim 1, wherein sequestering the initial volume of bodily fluid includes sequestering the initial volume of bodily fluid in a pre-sample reservoir, the pre-sample reservoir at least partially defined by the channel.

4. The method of claim 3, wherein the initial volume of bodily fluid within the pre-sample reservoir is fluidically isolated from the second fluid flow path.

5. The method of claim 3, wherein the initial volume of bodily fluid is fluidically isolated in the pre-sample reservoir.

6. The method of claim 1, wherein the valve is disposed at an inlet of the channel.

7. The method of claim 1, wherein the valve disposed in the channel is configured to sequester the initial volume of bodily fluid from the second fluid flow path.

8. The method of claim 7, wherein the valve disposed in the channel is configured to fluidically isolate the initial volume of bodily fluid from the second fluid flow path.

9. The method of claim 1, wherein the valve disposed in the channel is configured to prevent the sequestered initial volume of bodily fluid from flowing out of the channel toward a sample reservoir.

10. The method of claim 9, wherein the valve disposed in the channel is configured to fluidically isolate the initial volume of bodily fluid from the second fluid flow path.

11. The method of claim 1, wherein the valve is configured to transition from a first operating mode in which the initial volume of bodily fluid is allowed to flow from the patient to the channel, to a second operating mode in which the valve is closed, which is configured to allow a negative pressure in the second fluid flow path to form, creating a suction force operable to draw the subsequent volume of bodily fluid from the patient.

12. The method of claim 11, wherein the bodily fluid sequestration device is configured to automatically transition from the first operating mode to the second operating mode.

13. The method of claim 1, further comprising:

moving an actuator mechanism from a first position to a second position to draw the initial volume of bodily fluid from the patient into a pre-sample reservoir.

14. The method of claim 13, further comprising:

moving the actuator mechanism from the second position to a third position to draw the subsequent volume of bodily fluid into the second fluid flow path.

27. The method of claim 1, wherein the volume of bodily fluid with reduced contamination is provided to a sample vessel containing a culture media,

whereby sequestration of the initial volume of bodily fluid sequesters contaminants present in the initial volume of bodily fluid, thereby reducing contamination in the volume of bodily fluid received into the sample vessel.

15. A method of sequestering bodily fluid withdrawn from a patient with a bodily fluid sequestration device, the method comprising:

establishing fluid communication between the patient and a channel of the bodily fluid sequestration device via a port, the channel defining a first fluid flow path and including a valve configured to form a substantially fluid tight seal with walls defining the channel;

receiving, without moving at least a portion of the valve relative to the port, an initial volume of bodily fluid from the patient into a pre-sample reservoir of the bodily fluid sequestration device via the port and the first fluid flow path, the first fluid flow path extending from a proximal end of the port when the initial volume of bodily fluid is received;

sequestering the initial volume of bodily fluid in the pre-sample reservoir;

after the initial volume of bodily fluid is sequestered, receiving a subsequent volume of bodily fluid from the patient via a second fluid flow path of the bodily fluid sequestration device, at least a portion of the second fluid flow path formed separately from the first fluid flow path;

the valve being operative to move from a closed configuration to an open configuration in response to a difference in pressure between a valve inlet and a valve outlet,

the valve being further operative to return to the closed configuration in response to equalization of pressure between the valve inlet and the valve outlet, which is configured to allow the creation of a negative pressure in the second fluid flow path operable to draw the subsequent volume of bodily fluid from the patient;

establishing fluid communication with a sample vessel containing a culture medium; and

providing via the second fluid flow path a volume of bodily fluid into the sample vessel, the volume of bodily fluid having reduced contamination due to the sequestration of the initial volume of bodily fluid.

16. The method of claim 15, wherein the valve is a one-way check valve.

17. The method of claim 15, wherein sequestering the initial volume of bodily fluid includes sequestering the initial volume of bodily fluid in a pre-sample reservoir, the pre-sample reservoir at least partially defined by the channel.

18. The method of claim 17, wherein the initial volume of bodily fluid within the pre-sample reservoir is fluidically isolated from the second fluid flow path.

19. The method of claim 17, wherein the initial volume of bodily fluid is fluidically isolated in the pre-sample reservoir.

20. The method of claim 15, wherein the valve is disposed at an inlet of the channel.

21. The method of claim 15, wherein the valve disposed in the channel is configured to sequester the initial volume of bodily fluid from the second fluid flow path.

22. The method of claim 21, wherein the valve disposed in the channel is configured to fluidically isolate the initial volume of bodily fluid from the second fluid flow path.

23. The method of claim 15, wherein the valve disposed in the channel is configured to prevent the sequestered initial volume of bodily fluid from flowing out of the channel toward a sample reservoir.

24. The method of claim 23, wherein the valve disposed in the channel is configured to fluidically isolate the initial volume of bodily fluid from the second fluid flow path.

25. The method of claim 15, further comprising:

moving an actuator mechanism from a first position to a second position to draw the initial volume of bodily fluid from the patient into a pre-sample reservoir.

26. The method of claim 25, further comprising:

moving the actuator mechanism from the second position to a third position to draw the subsequent volume of bodily fluid into the second fluid flow path.