Fluid diversion mechanism for bodily-fluid sampling

• US 10,265,007 B2
• Filed: 05/14/2015
• Issued: 04/23/2019
• Est. Priority Date: 10/13/2011
• 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.
• Primary Examiner(s): Eiseman, Adam J
• Application Number:
  US14/712,431
• Publication Number:
  US 20150351678A1
• Time in Patent Office: 1,440 Days
• 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 device for parenterally-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;

a fluid reservoir disposed within the housing, the fluid reservoir configured to be selectively placed in fluid communication with the inlet port; and

a flow control mechanism disposed in the inner volume and configured to be transitioned between a first configuration and a second configuration, the flow control mechanism including a first seal member and a second seal member collectively defining at least a portion of the fluid reservoir, the first seal member configured to move relative to the second seal member from a first position to a second position in response to a force to place the flow control mechanism in the first configuration in which the inlet port is in fluid communication with the fluid reservoir,

the first seal member and the second seal member collectively configured to move relative to the housing in response to the force after the first seal member is placed in the second position to transition the flow control mechanism to the second configuration in which the inlet port is in fluid communication with an outlet port, the second seal member fluidically isolating the fluid reservoir from the inlet port when the flow control mechanism is in the second configuration.

2. The device of claim 1, wherein the movement of the first seal member from the first position to the second position is configured to form a negative pressure in the fluid reservoir.

3. The device of claim 1, wherein the flow control mechanism includes a control member coupled to the first seal member, the control member configured to move within the housing to move the first seal member from the first position to the second position in response to a sample reservoir being inserted a first distance into the inner volume, the movement of the first seal member from the first position to the second position configured to from a negative pressure in the fluid reservoir.

4. The device of claim 3, wherein the control member is configured to move within the housing to collectively move the first seal member and the second seal member relative to the housing in response to the sample reservoir being inserted a second distance into the inner volume.

5. The device of claim 1, wherein at least one of the housing or the flow control mechanism defines the outlet port, the fluid reservoir being fluidically isolated from the outlet port.

6. The device of claim 1, further comprising:

an actuator operably coupled to the flow control mechanism, the actuator configured to exert the force when actuated by a user.

7. A device for parenterally-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;

a fluid reservoir disposed within the housing, the fluid reservoir configured to be selectively placed in fluid communication with the inlet port; and

a flow control mechanism disposed in the inner volume and configured to be transitioned from a first configuration to a second configuration, the flow control mechanism including a first seal member and a second seal member, a volume defined between the first seal member and the second seal member forming at least a portion of the fluid reservoir, the flow control mechanism further including a first control member and a second control member, the first control member configured to move a first distance in response to a force to place the flow control mechanism in the first configuration in which the inlet port is in fluid communication with the fluid reservoir, the first seal member configured to move relative to the second seal member as the first control member is moved the first distance such that the volume defined between the first seal member and the second seal member is increased from a first volume to a second volume,

the first control member configured to move a second distance after moving the first distance in response to the force to place the flow control mechanism in the second configuration in which the inlet port is placed in fluid communication with an outlet port, the second seal member configured to move with the first control member as the first control member is moved the second distance to fluidically isolate the fluid reservoir from the inlet port.

8. The device of claim 7, wherein the housing defines the outlet port, the outlet port being fluidically isolated from the fluid reservoir.

9. The device of claim 7, wherein the second control member defines the outlet port and at least a portion of the fluid reservoir, the outlet port being fluidically isolated from the fluid reservoir.

10. The device of claim 7, wherein the increase in the volume defined between the first seal member and the second seal member from the first volume to the second volume forms a negative pressure in the volume.

11. The device of claim 7, wherein the first seal member and the second seal member collectively define a first fluid flow path configured to place the fluid reservoir in fluid communication with the inlet port, the second seal member fluidically isolating the first fluid flow path from the inlet port when the first control member is moved the second distance.

12. The device of claim 7, wherein the first seal member is maintained in a fixed position relative to the first control member, the second seal member configured to move relative to the first control member.

13. The device of claim 12, wherein the second seal member is maintained in a fixed position relative to the second control member.

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

a housing including a proximal end portion and a distal end portion, the housing having an inner surface defining an inner volume, the housing including an inlet port and an outlet port in fluid communication with the inner volume;

a first control member disposed in the inner volume and operably coupled to a first seal member, the first seal member forming a substantially fluid tight seal with the inner surface of the housing;

a second control member disposed in the inner volume and operably coupled to a second seal member, the second seal member forming a substantially fluid tight seal with the inner surface of the housing, a portion of the inner volume defined between the first seal member and the second seal member defining at least a portion of a fluid reservoir; and

an actuator operably coupled to the housing, the actuator configured to move the first control member within the housing from a first position to a second position in response to a actuation force, the first control member being placed in contact with the second control member when in the second position, the inlet port being in fluid communication with the fluid reservoir as the first control member is moved from the first position to the second position,

the actuator configured to move the first control member within the housing from the second position to a third position in response to the actuation force, the second control member moving with the first control member as the first control member is moved from the second position to the third position, the second seal member fluidically isolating the fluid reservoir from the inlet port and placing the inlet port in fluid communication with the outlet port when the first control member is in the third position.

15. The device of claim 14, wherein the first control member and the second control member are included in a flow control mechanism, the flow control mechanism being operably coupled to the actuator.

16. The device of claim 14, wherein the first seal member and the second seal member collectively define a first fluid flow path configured to place the fluid reservoir in fluid communication with the inlet port, the second seal member fluidically isolating the first fluid flow path from the inlet port when the first control member is in the third position.

17. The device of claim 14, wherein the second sealing member includes a first seal element forming a substantially fluid tight seal with the inner surface of the housing and a second seal element spaced apart from the first seal element and forming a substantially fluid tight seal with the inner surface of the housing, the first seal element and the second seal element defining a second fluid flow path configured to place the inlet port in fluid communication with the outlet port, the second fluid flow path being fluidically isolated from the fluid reservoir.

18. The device of claim 14, wherein the first seal member is maintained in a fixed position relative to the first control member, the first seal member being moved relative to the second seal member when the first control member is moved from the first position to the second position such that a volume associated with the fluid reservoir is increased, the increase in the volume associated with the fluid reservoir operable in forming a negative pressure within the fluid reservoir.

19. The device of claim 14, wherein the actuator includes a tab configured to be transitioned from a first configuration to a second configuration, the tab limiting movement of the actuator relative to the housing to at least temporarily maintain the first control member in the first position.

20. The device of claim 19, wherein the tab is a first tab, the actuator including a second tab configured to be placed in contact with a surface of the housing when the first control member is placed in the third position, the second tab limiting movement of the first control member relative to the housing beyond the third position.