Fluid diversion mechanism for bodily-fluid sampling

• US 9,022,950 B2
• Filed: 09/23/2014
• Issued: 05/05/2015
• Est. Priority Date: 05/30/2012
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: Patton, Richard G., Miazga, Jay M., Gaw, Shan E., Bullington, Gregory
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US14/493,796
• Publication Number:
  US 20150011911A1
• Time in Patent Office: 224 Days
• Field of Search: 600/573, 600/579, 604/30, 604/33, 604/246, 604/249, 604/256
• US Class Current: 600/579
• 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 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• 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 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• 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 fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

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 an inlet port of the parenteral sampling device;

disposing a flow control mechanism in a first configuration, the first configuration operable to allow bodily-fluid to flow from the patient, through the inlet port, and into a fluid reservoir;

moving an actuator a first distance to form a negative pressure in the fluid reservoir, the actuator including a seal member that defines a portion of the fluid reservoir such that the moving of the actuator the first distance moves the seal member from a first position toward a second position to form the negative pressure in the fluid reservoir;

receiving a first volume of bodily-fluid into the fluid reservoir while the flow control mechanism is in the first configuration;

moving the actuator a second distance, after the first volume of bodily-fluid has been received into the fluid reservoir, to move the flow control mechanism from the first configuration to a second configuration, the second configuration operable to (1) fluidically isolate the first volume of bodily-fluid in the fluid reservoir, and (2) allow bodily-fluid to flow from the patient to a sample reservoir.

2. The method of claim 1, wherein the disposing the flow control mechanism in the first configuration includes transitioning the flow control mechanism from a third configuration, in which the inlet port is fluidically isolated from the fluid reservoir and the outlet port, to the first configuration.

3. The method of claim 1, wherein the moving the actuator the first distance includes moving the actuator the first distance in response to an activation force, the activation force configured to be modulated to correspondingly modulate the negative pressure.

4. The method of claim 1, wherein the flow control mechanism defines a first fluid flow path and a second fluid flow path, the receiving the first volume of the bodily-fluid into the fluid reservoir while the flow control mechanism is in the first configuration includes receiving the first volume of the bodily-fluid into the fluid reservoir via the first fluid flow path, the moving of the actuator the second distance includes placing the flow control mechanism in the second configuration such that the second fluid flow path places the inlet port in fluid communication with an outlet port.

5. The method of claim 1, further comprising:

coupling the inlet port to a needle prior to the establishing fluid communication between the patient and the inlet port; and

coupling the outlet port to the sample reservoir.

6. The method of claim 5, wherein the establishing fluid communication between the patient and the inlet port includes puncturing a portion of skin of the patient to place the needle in fluid communication with a vein.

7. The method of claim 5, wherein the sample reservoir defines a negative pressure operable to draw bodily-fluid from the patient to the sample reservoir after the actuator is moved the second distance and the flow control mechanism is placed in the second configuration.

8. 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 defining a first fluid flow path and a second fluid flow path and being operable to selectively control fluid flow between the inlet port and at least one of a pre-sample reservoir and an outlet port, the method comprising:

establishing fluid communication between the patient and the inlet port;

moving the actuator a first distance while the flow control mechanism is in a first configuration to move a seal member from a first position toward a second position to create a suction force in the pre-sample reservoir, the suction force operable to draw a first volume of bodily-fluid from the patient through the inlet port and the first fluid flow path and into the pre-sample reservoir;

moving the actuator a second distance to transition the flow control mechanism from the first configuration to a second configuration, the second configuration operable to divert the flow of bodily-fluid from the patient through the inlet port and the second fluid flow path to a sample reservoir, the first volume of bodily-fluid being fluidically isolated in the pre-sample reservoir when the flow control mechanism is in the second configuration.

9. The method of claim 8, further comprising:

coupling the inlet port to a needle prior to establishing fluid communication between the patient and the inlet port, the establishing fluid communication between the patient and the inlet port includes puncturing a portion of skin of the patient to place the needle in fluid communication with a vein.

10. The method of claim 8, wherein the moving the actuator the first distance places the flow control mechanism in the first configuration, the first fluid flow path configured to place the inlet port in fluid communication with the fluid reservoir when the flow control mechanism is in the first configuration.

11. The method of claim 8, wherein the moving the actuator the first distance and the moving the actuator the second distance includes the actuator moving in response to an activation force.

12. The method of claim 8, further comprising:

moving the actuator a third distance to move the seal member from the second position toward the first position to modulate the suction force in the pre-sample reservoir.

13. The method of claim 8, wherein the actuator is moved the first distance and the second distance in a substantially linear direction, the actuator configured to rotate the flow control mechanism between the first configuration and the second configuration.

14. A method for procuring bodily-fluid samples from a patient using a parenteral sampling device, the device including a needle configured for insertion into the patient, an actuator including a seal member defining a portion of a fluid reservoir, and a flow control mechanism configured to selectively place the fluid reservoir in fluid communication with the needle, the method comprising:

inserting the needle into the patient;

establishing fluid communication between the needle and the fluid reservoir;

disposing the flow control mechanism in a first configuration, the first configuration operable to allow bodily-fluid to flow from the patient, through a first fluid flow path, and into the fluid reservoir;

exerting an activation force on a portion of the actuator to move the seal member from a first position, in which the fluid reservoir has a first volume, toward a second position, in which the fluid reservoir has a second volume greater than the first volume, the increase in volume of the fluid reservoir operable to allow a predetermined volume of bodily-fluid to flow into the fluid reservoir;

transitioning the flow control mechanism from the first configuration to a second configuration in response to the seal member being placed in the second position, the flow control mechanism operable to allow bodily-fluid to flow through a second fluid flow path from the needle to a sample reservoir when the flow control mechanism is in the second configuration.

15. The method of claim 14, wherein the increase in volume in the fluid reservoir creates a suction force in the fluid reservoir operable to draw the predetermined volume of bodily-fluid from the patient through the inlet port and the first fluid flow path to the fluid reservoir.

16. The method of claim 15, further comprising:

modulating the activation force exerted on the portion of the actuator to modulate the suction force created in the fluid reservoir.

17. The method of claim 16, wherein the predetermined volume of bodily-fluid is drawn into the fluid reservoir via the first fluid flow path when the flow control mechanism is in the first configuration, the modulating of the actuator force exerted on the portion of the actuator operable to at least partially obstruct the first fluid flow path.

18. The method of claim 14, further comprising:

coupling the parenteral sampling device to a sample reservoir, the sample reservoir having a negative pressure that produces a suction force in at least the second fluid flow path operable to draw bodily-fluid from the patient to the sample reservoir when the flow control mechanism is placed in the second configuration.

19. The method of claim 18, further comprising:

manipulating an adjustment mechanism to place a portion of the adjustment mechanism in contact with a portion of the flow control mechanism, the adjustment mechanism configured to at least partially obstruct the second fluid flow path when the flow control mechanism is in the second configuration to reduce the suction force in at least a portion of the second fluid flow path.

20. The method of claim 14, wherein the predetermined volume of bodily-fluid is substantially equal to a differential between the second volume of the fluid reservoir and the first volume of the sample reservoir.