Syringe-based fluid diversion mechanism for bodily fluid sampling

• US 9,155,495 B2
• Filed: 12/02/2013
• Issued: 10/13/2015
• 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 F
• Application Number:
  US14/094,073
• Publication Number:
  US 20140163419A1
• Time in Patent Office: 680 Days
• US Class Current: 1/1
• 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 syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination 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 proximal end portion being substantially open and the distal end portion having a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient;

a pre-sample reservoir fluidically coupleable to the port and configured to receive and isolate a first volume of bodily fluid withdrawn from the patient; and

an actuator mechanism at least partially disposed in the inner volume of the housing, the actuator mechanism having a proximal end portion and a distal end portion, the distal end portion including a sealing member and the proximal end portion including an engagement portion configured to allow a user to selectively move the actuator mechanism,

the actuator mechanism configured to move between a first configuration in which the bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration in which the bodily fluid can flow from the port to a sample reservoir, the sample reservoir defined at least in part by the sealing member and the housing.

2. The device of claim 1, wherein the actuator mechanism defines an inner volume between the proximal end portion and the distal end portion of the actuator mechanism.

3. The device of claim 2, wherein the pre-sample reservoir is disposed in the inner volume of the actuator mechanism.

4. The device of claim 2, wherein the proximal end portion of the actuator mechanism is substantially open and configured to receive a vacuum-sealed sample tube.

5. The device of claim 2, further comprising:

a piercing member disposed in the inner volume of the actuator mechanism and configured to be fluidically coupled to the port to provide selective communication between the port and the inner volume defined by the actuator mechanism.

6. The device of claim 2, further comprising:

a flow control mechanism operable to selectively control fluid flow between the port and the pre-sample reservoir, the flow control mechanism being configured to be moved between a first configuration in which the bodily fluid can flow through a first flow path to the pre-sample reservoir, and a second configuration in which the bodily fluid can flow through a second flow path to the sample reservoir.

7. A syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination 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 proximal end portion being substantially open and the distal end portion having a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient;

an actuator mechanism movably disposed in the inner volume of the housing, the actuator mechanism having a proximal end portion and a distal end portion, the distal end portion including a first plunger and the proximal end portion including an engagement portion configured to allow a user to selectively move the actuator mechanism;

a second plunger movably disposed in the inner volume of the housing and releasably coupled to the actuator mechanism, the second plunger defining a flow channel configured to be placed in selective fluid communication with the port; and

a flow control mechanism operable to selectively control fluid flow between the port and a pre-sample reservoir, the second plunger and the housing defining the pre-sample reservoir,

the flow control mechanism being configured to be moved between a first configuration in which the bodily fluid can flow through a first flow path to the pre-sample reservoir, and a second configuration in which the bodily fluid can flow through a second flow path to a sample reservoir, the first plunger, the second plunger, and the housing collectively defining the sample reservoir.

8. The device of claim 7, wherein the flow control mechanism includes a valve member movably disposed in at least a portion of the housing, the valve member defining a first lumen and a second lumen.

9. The device of claim 8, wherein the valve member allows bodily fluid to flow from the port, through the first lumen, and into the pre-sample reservoir when the valve member is in a first position.

10. The device of claim 9, wherein the valve member allows bodily fluid to flow from the port, through the second lumen, through the flow channel of the second plunger, and into the sample reservoir when the valve is in a second position.

11. The device of claim 7, wherein the second plunger includes a protrusion configured to selectively engage the actuator mechanism.

12. A method of using a syringe-based transfer device to obtain a bodily fluid sample from a patient, the syringe-based transfer device including a housing having a port configured to be coupled to the patient, and an actuator mechanism movably disposed in the housing, the method comprising:

establishing fluid communication between the patient and the port of the syringe-based transfer device;

establishing fluid communication between the port and a pre-sample reservoir;

transferring a first volume of bodily fluid to the pre-sample reservoir with the syringe-based transfer device;

fluidically isolating the pre-sample reservoir from the port to sequester the first volume of bodily fluid in the pre-sample reservoir;

after the first volume of bodily fluid has been sequestered in the pre-sample reservoir, establishing fluid communication between the port and a sample reservoir defined at least in part by the actuator mechanism and the housing;

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

13. The method of claim 12, further comprising:

establishing fluid communication between the port and a first sample vessel; and

transferring a third volume of bodily fluid from the sample reservoir to the first sample vessel, the third volume of bodily fluid being at least a portion of the second volume of bodily fluid.

14. The method of claim 13, wherein the bodily fluid is blood.

15. The method of claim 14, wherein the first sample vessel includes at least one of aerobic culture media and anaerobic culture media.

16. The method of claim 13, further comprising:

establishing fluid communication between the port and a second sample vessel; and

transferring a fourth volume of bodily fluid from the sample reservoir to the second sample vessel, the fourth volume of bodily fluid being at least a portion of the second volume of bodily fluid.

17. The method of claim 16, wherein the bodily fluid is blood.

18. The method of claim 17, wherein the second sample vessel includes at least one of aerobic culture media and anaerobic culture media.