Fluid diversion mechanism for bodily-fluid sampling

• US 8,864,684 B2
• Filed: 07/30/2013
• Issued: 10/21/2014
• 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., Gaw, Shan E., Miazga, Jay M
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/954,528
• Publication Number:
  US 20130317391A1
• Time in Patent Office: 448 Days
• Field of Search: 600573-584
• US Class Current: 600/579
• 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 method of obtaining a bodily-fluid sample from a patient using a parenteral sampling device, the method comprising:

establishing fluid communication between the patient and a fluid reservoir;

moving an actuator from a first position to a second position, including moving a first sealing member away from a second sealing member a first distance, to create a negative pressure in the fluid reservoir, the fluid reservoir at least partially defined by the first sealing member and the second sealing member;

receiving a first volume of bodily-fluid into the fluid reservoir;

after the first volume of bodily-fluid has been received into the fluid reservoir, moving the actuator a second distance to engage a flow control mechanism and move the flow control mechanism from a first configuration to a second configuration, the first configuration operable to allow bodily-fluid to flow from the patient to the fluid reservoir, the second configuration operable to fluidically isolate the first volume of bodily-fluid in the fluid reservoir and to allow bodily-fluid to flow from the patient through the parenteral sampling device and to an outlet port.

2. The method of claim 1, wherein moving the actuator the second distance includes moving the first sealing member and the second sealing member the second distance to place the flow control mechanism in the second configuration.

3. The method of claim 1, wherein moving the actuator from the first position to the second position includes applying an activation force to the actuator to create the negative pressure in the fluid reservoir.

4. The method of claim 3, further comprising:

releasing the activation force to reduce the negative pressure created in the fluid reservoir.

5. A method for procuring bodily-fluid samples using a parenteral sampling device, the device including a needle having a lumen configured for insertion into the patient, and a fluid reservoir fluidically coupleable to the needle, the method comprising:

inserting the needle into the patient;

establishing fluid communication between the needle and the fluid reservoir;

moving an actuator a first distance, including moving a first sealing member away from a second sealing member, to increase the volume of the fluid reservoir and to create a negative pressure in the fluid reservoir, the fluid reservoir at least partially defined by the first sealing member and the second sealing member;

receiving a first volume of bodily-fluid into the fluid reservoir;

moving the actuator a second distance to engage a flow control mechanism and move the flow control mechanism from a first configuration to a second configuration, the first configuration operable to allow bodily-fluid to flow through a first flow path from the needle to the fluid reservoir, the second configuration operable to allow bodily-fluid to flow through a second flow path from the needle to a sample reservoir.

6. The method of claim 5, wherein moving the actuator the first distance includes applying an activation force to the actuator to create a pressure in a lumen of the needle that is lower than a fluid pressure in the portion of the patient in which the needle is inserted.

7. The method of claim 6, further comprising:

releasing the activation force to reduce the pressure differential between the pressure in the lumen of the needle and the fluid pressure in the portion of the patient in which the needle is inserted.

8. The method of claim 5, wherein moving the actuator the second distance includes moving the first sealing member and the second sealing member the second distance to establish fluid communication between the needle and the sample reservoir.

21. The method of claim 5, further comprising:

communicating a second volume of bodily-fluid to the sample reservoir.

9. A method for procuring bodily-fluid samples from a patient using a parenteral sampling device, the device including an inlet port configured to be fluidically coupled to the patient, an actuator, and a flow control mechanism operable to selectively control a fluid flow between the inlet port and at least one of a pre-sample reservoir and a sample reservoir, the method comprising:

establishing fluid communication between the patient and the inlet port;

moving the actuator from a first position to a second position, including moving a first sealing member away from a second sealing member a first distance, to create a suction force in the pre-sample reservoir operable to draw a first volume of bodily-fluid from the patient through the inlet port to the pre-sample reservoir, the pre-reservoir at least partially defined by the first sealing member and the second sealing member;

moving the actuator from the second position to a third position to divert the flow of bodily-fluid from the patient through the inlet port to a sample reservoir and to fluidically isolate the first volume of bodily-fluid in the pre-sample reservoir.

10. The method of claim 9, wherein moving the actuator from the first position to the second position includes applying an activation force to the actuator to create the suction force in the pre-sample reservoir.

11. The method of claim 10, further comprising:

releasing the activation force to reduce the suction force created in the pre-sample reservoir.

12. The method of claim 9, wherein moving the actuator from the second position to a third position includes engaging the flow control mechanism to divert the flow of bodily-fluid from the inlet port to the sample reservoir.

13. The method of claim 9, wherein moving the actuator from the second position to the third position seals the first volume of bodily-fluid between the first sealing member and the second sealing member.

14. The method of claim 9, further comprising:

establishing fluid communication between the patient and the sample reservoir.

15. A method for procuring bodily-fluid samples from a patient using a parenteral sampling device, the device including an inlet port configured to be fluidically coupled to the patient, a pre-sample reservoir fluidically coupleable to the inlet port, an outlet port configured to be fluidically coupled to the inlet port and a sample reservoir, and a flow control mechanism operable to selectively control fluid flow between the inlet port and at least one of the outlet port and the pre-sample reservoir, the method comprising:

establishing fluid communication between the patient and the inlet port;

moving the flow control mechanism a first distance, including moving a first sealing member away from a second sealing member, to create a negative pressure in the pre-sample reservoir and to withdraw a predetermined volume of bodily-fluid into the pre-sample reservoir, the fluid reservoir at least partially defined by the first sealing member and the second sealing member;

moving the flow control mechanism a second distance to fluidically isolate the first volume of bodily-fluid in the pre-sample reservoir and establish fluid communication between the inlet port and the outlet port.

16. The method of claim 15, wherein moving the flow control mechanism the second distance includes moving the first sealing member and the second sealing member the second distance to establish fluid communication between the inlet port and the outlet port.

17. The method of claim 15, wherein the inlet port is axially offset from the outlet port such that movement of the flow control mechanism the second distance includes moving a sealing member from a first position in which the outlet port is fluidically isolated from the inlet port to a second position in which the outlet port is in fluid communication with the inlet port.

18. The method of claim 17, wherein the pre-sample reservoir is fluidically coupled to the inlet port when the sealing member is in the first position and the pre-sample reservoir is fluidically isolated from the inlet port and the outlet port when the sealing member is in the second position.

19. The method of claim 17, wherein the sealing member includes a first seal element and a second seal element spaced apart from the first seal element, the first seal element and the second seal element defining an annular void therebetween such that the bodily-fluid can flow from the inlet port, through the annular void and to the outlet port when the sealing member is in the second position.

20. The method of claim 15, further comprising:

communicating a second volume of bodily-fluid to the sample reservoir.

22. The method of claim 15, wherein moving the flow control mechanism the first distance includes applying an activation force to the flow control mechanism to create the negative pressure in the pre-sample reservoir.

23. The method of claim 22, further comprising:

releasing the activation force to reduce the negative pressure created in the pre-sample reservoir.