FLUID DIVERSION MECHANISM FOR BODILY-FLUID SAMPLING

• US 20150257691A1
• Filed: 03/19/2015
• Published: 09/17/2015
• Est. Priority Date: 05/30/2012
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: BULLINGTON, Gregory, Patton, Richard G., MIAZGA, Jay M., GAW, Shan E.
• Granted Patent: US 10,292,633 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 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, the housing having an inlet port configured to be fluidically coupled to the patient, and an outlet port configured to be fluidically coupled to a sample reservoir;

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 disposed in the housing and defining a first lumen and a second lumen, the flow control mechanism configured for rotational movement from a first configuration, in which the inlet port is placed in fluid communication with the fluid reservoir such that bodily-fluid can flow from the inlet port, through the first lumen and to the fluid reservoir, to a second configuration, in which the inlet port is placed in fluid communication with the outlet port such that the bodily-fluid can flow from the inlet, through the second lumen and to the outlet port; and

an actuator operably coupled to the flow control mechanism and configured to create a negative pressure in the fluid reservoir when actuated by a user, the actuator further 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 from the patient.

2. The device of claim 1, wherein the actuator is further configured to move a first distance to create the negative pressure in the fluid reservoir when actuated by a user.

3. The device of claim 2, wherein the actuator is further configured to move a second distance to rotate the flow control mechanism from the first configuration to the second configuration.

4. 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.

5. The device of claim 1, wherein the actuator is configured to allow the user to modulate the negative pressure created in the fluid reservoir.

6. 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 in the housing, the actuator including a sealing member and a fluid reservoir defined at least in part by the sealing member, the actuator configured to create a negative pressure in the fluid reservoir when actuated by a user;

a diverter disposed in the housing, 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 a sample reservoir; and

a flow control mechanism disposed in the diverter and defining a first lumen and a second lumen, the flow control mechanism configured for rotational movement between a first configuration, in which the inlet port is placed in fluid communication with the first outlet port such that bodily-fluid can flow from the inlet port, through the first lumen and to the first outlet port, to a second configuration, in which the inlet port is placed in fluid communication with the second outlet port such that the bodily-fluid can flow from the inlet, through the second lumen and to the second outlet port.

7. The device of claim 6, wherein the actuator is further configured to rotate the flow control mechanism from the first configuration to the second configuration after a first volume of bodily-fluid is received in the fluid reservoir from the patient.

8. The device of claim 7, wherein the actuator is configured to move a first distance to create the negative pressure in the fluid reservoir, and to move a second distance to rotate the flow control mechanism from the first configuration to the second configuration, when actuated by a user.

9. The device of claim 6, 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.

10. The device of claim 6, wherein the actuator further includes a plunger operably coupled to the sealing member.

11. The device of claim 10, 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.

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

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

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

a flow control mechanism disposed in the housing and defining a first lumen and a second lumen, the flow control mechanism configured for rotational movement between a first configuration, in which the inlet port is placed in fluid communication with a fluid reservoir defined at least in part by the housing such that bodily-fluid can flow from the inlet port, through the first lumen and to the fluid reservoir, to a second configuration, in which the inlet port is placed in fluid communication with the outlet port such that the bodily-fluid can flow from the inlet, through the second lumen and to the outlet port; and

an actuator movably disposed in the housing and operably coupled to the flow control mechanism, the actuator configured to create a negative pressure in the fluid reservoir when actuated by a user, the actuator further configured to rotate the flow control mechanism from the first configuration to the second configuration after a first volume of bodily-fluid is received in the fluid reservoir from the patient.

15. The device of claim 14, wherein the actuator includes an activation mechanism configured to rotate the flow control mechanism from the first configuration to the second configuration.

16. The device of claim 15, 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 rotate the flow control mechanism from the first configuration to the second configuration.

17. The device of claim 14, wherein the actuator is further configured to create the negative pressure in the fluid reservoir when the actuator is moved from a first position to a second position by the user.

18. The device of claim 17, wherein the actuator is further configured to rotate the flow control mechanism from the first configuration to the second configuration when the actuator is moved from the second position to a third position by the user.

19. The device of claim 18, wherein the actuator includes an activation mechanism and the flow control mechanism includes a set of protrusions, the activation mechanism configured to operably engage the set of protrusions to rotate the flow control mechanism from the first configuration to the second configuration when the actuator is moved from the second position to a third position by the user.

20. 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, the housing having an inlet port configured to be fluidically coupled to the patient;

a seal member movably disposed in the inner volume;

a fluid reservoir disposed in the inner volume and at least partially defined by the seal member, the fluid reservoir configured to receive and isolate a first volume of bodily-fluid withdrawn from the patient;

a flow control mechanism movably disposed in the housing, the flow control mechanism configured to move between a first configuration, in which the bodily-fluid can flow from the inlet port, through the flow control mechanism and to the fluid reservoir, and a second configuration, in which the fluid reservoir is fluidically isolated from the inlet port; and

an actuator operably coupled to the seal member and to the flow control mechanism, the actuator including a spring configured to move the seal member from a first position to a second position to create a negative pressure in the fluid reservoir, the actuator further configured to move the flow control mechanism from the first configuration to the second configuration after a first volume of bodily-fluid is received in the fluid reservoir from the patient.

21. The device of claim 20, further comprising:

a throttling button operably coupled to the actuator and configured to modulate the rate at which the spring moves the seal member from the first position to the second position based on user manipulation of the throttling button.

22. The device of claim 20, wherein the flow control mechanism includes a first control member and a second control member, the second control member defining a first lumen and a second lumen, the flow control mechanism configured for rotational movement between the first configuration in which the inlet port is placed in fluid communication with the fluid reservoir such that bodily-fluid can flow from the inlet port, through the first lumen and to the fluid reservoir, to a second configuration, in which the inlet port is placed in fluid communication with a sample reservoir such that the bodily-fluid can flow from the inlet, through the second lumen and to the sample reservoir.

23. The device of claim 22, wherein the first control member includes a protrusion movably disposed in a grove defined by the second control member, the protrusion configured to move in the grove as the spring moves the seal member from the first position to the second position.

24. The device of claim 23, wherein the protrusion is configured to rotate the second control member when the spring moves the seal member from the second position to a third position.

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

a flow control mechanism disposed in the housing, the flow control mechanism including a first control member and a second control member, the second control member defining a first lumen and a second lumen and configured for rotational movement between a first configuration in which the inlet port is placed in fluid communication with a fluid reservoir defined at least in part by the housing such that bodily-fluid can flow from the inlet port, through the first lumen and to the fluid reservoir, to a second configuration, in which the inlet port is placed in fluid communication with the outlet port such that the bodily-fluid can flow from the inlet, through the second lumen and to the outlet port; and

an actuator movably disposed in the housing and operably coupled to the first control member, the actuator configured to create a negative pressure in the fluid reservoir when actuated by a user, the actuator further configured to rotate the second control member from the first configuration to the second configuration after a first volume of bodily-fluid is received in the fluid reservoir from the patient.

26. The device of claim 25, wherein the actuator includes an activation mechanism operably coupled to the first control member and configured to rotate the second control member from the first configuration to the second configuration.

27. The device of claim 25, wherein the actuator is further configured to create the negative pressure in the fluid reservoir when the actuator is moved from a first position to a second position by the user.

28. The device of claim 27, wherein the actuator is further configured to rotate the second control member from the first configuration to the second configuration when the actuator is moved from the second position to a third position by the user.

29. The device of claim 28, further comprising:

an activation mechanism coupled to the first control member, the activation mechanism including a protrusion configured to operably engage the actuator when the actuator is moved from the second position to a third position by the user.

30. 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 of the device into the patient;

establishing fluid communication between the needle and the fluid reservoir;

moving an actuator a first distance to create a negative pressure in the fluid reservoir and to withdraw a predetermined volume of bodily-fluid;

moving the actuator a second distance to engage a flow control mechanism and rotate 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.

31. The method of claim 30, wherein moving the actuator the first distance includes applying an activation force to the actuator in a first direction.

32. The method of claim 31, wherein releasing the activation force allows the actuator to move in a second direction opposite the first direction, to reduce the negative pressure created in the fluid reservoir.

33. The method of claim 30, further comprising:

moving the actuator a third distance to reduce the flow rate of bodily-fluid through the second flow path to the sample reservoir in the second configuration.

34. The method of claim 33, further comprising:

moving the actuator a third distance to engage a control member and deform the second flow path reduce the flow rate of bodily-fluid through the second flow path to the sample reservoir in the second configuration.

35. 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 of the device into the patient;

establishing fluid communication between the needle and the fluid reservoir;

applying a first activation force to an actuator to create a negative pressure in the fluid reservoir and to withdraw a predetermined volume of bodily-fluid;

reducing the first activation force applied to the actuator to reduce the negative pressure created in the fluid reservoir; and

applying a second activation force to the actuator 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.

36. The method of claim 35, wherein the first activation force moves the actuator a first distance in a first direction to create the negative pressure in the fluid reservoir.

37. The method of claim 36, wherein reducing the first activation force allows the actuator to move in a second direction opposite the first direction, to reduce the negative pressure created in the fluid reservoir.

38. The method of claim 35, wherein the second activation force moves the actuator a second distance in the first direction to move the flow control mechanism from the first configuration to the second configuration.

39. The method of claim 35, further comprising:

applying a third activation force to reduce the flow rate of bodily-fluid through the second flow path to the sample reservoir in the second configuration.