Fluid diversion mechanism for bodily-fluid sampling

• US 10,433,779 B2
• Filed: 05/14/2015
• Issued: 10/08/2019
• Est. Priority Date: 05/30/2012
• 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 J
• Application Number:
  US14/712,437
• Publication Number:
  US 20150351679A1
• Time in Patent Office: 1,608 Days
• 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 5/15003 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 5/150229 Pumps for assisting the blood sampling
• 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 5/150946 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 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes

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 device for procuring bodily-fluid samples from a patient, the device comprising:

a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween;

a fluid reservoir disposed in the inner volume and configured to receive and isolate a first volume of bodily-fluid withdrawn from the patient;

a flow control mechanism at least partially disposed in the housing and configured to be placed in fluid communication with a patient, the flow control mechanism defining a first lumen and a second lumen, the flow control mechanism configured for movement from a first configuration, in which the first lumen places the fluid reservoir in fluid communication with the patient, to a second configuration, in which the second lumen places a sample reservoir in fluid communication with the patient; and

an actuator operably coupled to the flow control mechanism and configured to be moved a first distance to create a negative pressure in the fluid reservoir and a second distance to transition 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 from the patient.

2. The device of claim 1, wherein the actuator is configured to move in a first direction to create the negative pressure in the fluid reservoir, and to move in a second direction to reduce the negative pressure created in the fluid reservoir from movement in the first direction.

3. The device of claim 1, wherein the actuator is configured to create the negative pressure in the fluid reservoir in response to an applied force.

4. The device of claim 3, wherein the actuator is configured to modulate the negative pressure created in the fluid reservoir in response to a decrease in the applied force.

5. The device of claim 1, further comprising:

a diverter at least partially disposed in the housing, the diverter having an inlet port configured to be fluidically coupled to the patient, a first outlet port fluidically coupled to the fluid reservoir, and a second outlet port configured to be fluidically coupled to the sample reservoir.

6. The device of claim 5, wherein the flow control mechanism is at least partially disposed in the diverter and is configured to be transitioned from the first configuration, in which the inlet port, the first lumen, and the first outlet port collectively define a first fluid flow path between the patient and the fluid reservoir, to the second configuration in which the inlet port, the second lumen, and the second outlet port collectively define a second fluid flow path between the patient and the sample reservoir.

7. The device of claim 1, wherein the fluid reservoir is defined at least in part by the actuator, the actuator configured to move from a first position, in which the fluid reservoir has a first volume, to a second position, in which the fluid reservoir has a second volume greater than the first volume, the negative pressure in the fluid reservoir is generated in response to the increase in the volume of the fluid reservoir.

8. A device for procuring bodily-fluid samples from a patient, the device comprising:

a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween;

an actuator movably disposed, at least in part, in the housing, the actuator including a seal member and a fluid reservoir defined at least in part by the seal member, the actuator configured to be moved relative to the housing between a first position, in which the fluid reservoir has a first volume, and a second position, in which the fluid reservoir has a second volume greater than the first volume, when actuated by a user, the increase in the volume of the fluid reservoir resulting in a negative pressure within the fluid reservoir;

a diverter at least partially disposed in the housing, the diverter having an inlet port configured to be fluidically coupled to the patient, a first outlet port fluidically coupled to the fluid reservoir, and a second outlet port configured to be fluidically coupled to a sample reservoir, the diverter configured to move when the actuator is moved from the first position to the second position; and

a flow control mechanism at least partially disposed in the diverter and defining a first lumen and a second lumen, the flow control mechanism configured to be disposed in a first configuration, in which the first lumen places the inlet port in fluid communication with the first outlet port, as the actuator moves from the first position toward the second position, the flow control mechanism configured to be transitioned to a second configuration, in which the second lumen places the inlet port in fluid communication with the second outlet port, after the actuator is placed in the second position.

9. The device of claim 8, wherein the actuator further includes a plunger operably coupled to the seal member and configured to maintain the seal member in a substantially fixed position relative to the housing when the actuator moves from the first position to the second position, the seal member operable in creating the negative pressure in the fluid reservoir when a volume in the fluid reservoir is increased from the first volume to the second volume.

10. The device of claim 9, wherein the actuator further includes a spring operably coupled to the plunger, the spring configured to compress in response to an activation force when the actuator is actuated by a user.

11. The device of claim 10, wherein the spring is configured to expand and exert a reaction force when the activation force is removed.

12. The device of claim 11, wherein the spring is configured to allow the user to modulate the negative pressure created in the fluid reservoir.

13. The device of claim 8, wherein the housing includes an activation mechanism, the actuator configured to move the diverter relative to the housing when the actuator is moved from the first position to the second position to place the flow control mechanism in contact with the activation mechanism of the housing.

14. The device of claim 13, wherein the activation mechanism includes a first set of protrusions and the flow control mechanism includes a second set of protrusions, the first set of protrusions configured to operably engage the second set of protrusions to transition the flow control mechanism from the first configuration to the second configuration.

15. The device of claim 8, wherein the actuator including an inner surface that defines an inner volume, the seal member being disposed within the inner volume and forming a substantially fluid tight seal with the inner surface of the actuator, the inner surface of the actuator and the seal member collectively defining the fluid reservoir.

16. A device for procuring bodily-fluid samples from a patient, the device comprising:

a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween;

an actuator movably disposed, at least in part, in the housing, the actuator including a seal member and a fluid reservoir defined at least in part by the seal member, the actuator configured to be moved relative to the housing between a first position, in which the fluid reservoir has a first volume, and a second position, in which the fluid reservoir has a second volume greater than the first volume, the increase in the volume of the fluid reservoir resulting in a negative pressure within the fluid reservoir; and

a flow control mechanism at least partially disposed in the housing and configured to be placed in fluid communication with a patient and with a sample reservoir, the flow control mechanism defining a first lumen and a second lumen, the flow control mechanism operably coupled to the actuator and configured to be transitioned between a first configuration, in which the first lumen places the fluid reservoir in fluid communication with the patient, and a second configuration, in which the second lumen places the sample reservoir in fluid communication with the patient, as the actuator is moved between the first position and the second position.

17. The device of claim 16, wherein the flow control mechanism is configured to move with the actuator as the actuator is moved relative to the housing from the first position to the second position.

18. The device of claim 17, wherein the housing includes a control protrusion, the control protrusion configured to selectively engage a portion of the flow control mechanism to place the flow control mechanism in the second configuration when the actuator is placed in the second position relative to the housing.

19. The device of claim 16, wherein the flow control mechanism fluidically isolates the fluid reservoir when in the second configuration.

20. The device of claim 16, wherein the flow control mechanism is configured to be disposed in a third configuration, in which the first lumen and the second lumen are fluidically isolated from the patient, the fluid reservoir, and the sample reservoir.

21. The device of claim 16, wherein the actuator is configured to move in a linear motion relative to the housing from the first position to the second position, the actuator is configured to rotate the flow control mechanism to place the flow control mechanism in the second configuration when the actuator is in the second position.

22. The device of claim 16, further comprising:

a diverter at least partially disposed in the housing, the diverter configured to receive at least a portion of the flow control mechanism, the diverter having an inlet port configured to be fluidically coupled to the patient, a first outlet port configured to be fluidically coupleable to the fluid reservoir, and a second outlet port configured to be fluidically coupled to the sample reservoir.

23. The device of claim 22, wherein the inlet port is placed in fluid communication with the first outlet port via the first lumen when the flow control mechanism is in the first configuration, and wherein the inlet port is placed in fluid communication with the second outlet port via the second lumen when the flow control mechanism is in the second configuration.

24. The device of claim 23, wherein the actuator is operably coupled to the diverter, the actuator configured to move the diverter relative to the housing when the actuator is moved from the first position to the second position, the movement of the diverter relative to the housing operable in transitioning the flow control mechanism from the first configuration to the second configuration.

25. The device of claim 16, wherein the fluid reservoir is configured to receive a volume of bodily-fluid in a range of 0.1 mL to 5.0 mL.