Fluid diversion mechanism for bodily-fluid sampling

• US 9,060,725 B2
• Filed: 08/08/2014
• Issued: 06/23/2015
• 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 JARED
• Application Number:
  US14/455,263
• Publication Number:
  US 20150099996A1
• Time in Patent Office: 319 Days
• Field of Search: 600/573, 600/579, 604/30, 604/33, 604/246, 604/249, 604/256
• 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 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. An apparatus comprising:

an inlet port configured to be fluidically coupled to a patient;

a flow control mechanism fluidically coupled to the inlet port and defining a first fluid flow path and a second fluid flow path, the flow control mechanism including a first sealing member and a second sealing member disposed and configured to define the first fluid flow path an the second fluid flow path;

a fluid reservoir at least partially defined by the first sealing member of the flow control mechanism and configured to receive and isolate a first volume of bodily-fluid withdrawn from the patient, the first seal member configured to be moved 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; and

an actuator operably coupled to the flow control mechanism, the actuator configured to be moved a first distance to move the first sealing member from the first position toward the second position to allow the bodily-fluid to flow from the inlet port, through the first fluid flow path and to the fluid reservoir,

the actuator further configured to be moved a second distance to fluidically isolate the fluid reservoir from the inlet port.

2. The apparatus of claim 1, wherein the actuator is configured to be moved the second distance to move the first sealing member to the second position to fluidically isolate the fluid reservoir from the inlet port.

3. The apparatus of claim 1, wherein the movement of the first sealing member from the first position toward the second position forms a negative pressure in the fluid reservoir.

4. The apparatus of claim 1, further comprising:

an outlet port configured to be fluidically coupled to a sample reservoir.

5. The apparatus of claim 4, wherein the outlet port is fluidically isolated from the fluid reservoir.

6. The apparatus of claim 4, wherein the inlet port is placed in fluid communication with the outlet port when the first sealing member is in the second position such that the bodily fluid can flow from the inlet port, through the second fluid flow path and to the outlet port.

7. The device of claim 4, wherein the inlet port is axially offset from the outlet port such that the second sealing member fluidically isolates the inlet port from the outlet port in a first configuration.

8. The device of claim 7, wherein the second sealing member places the inlet port in fluid communication with the outlet port in a second configuration.

9. An apparatus comprising:

an inlet port configured to be fluidically coupled to a patient;

a flow control mechanism fluidically coupled to the inlet port and defining a first fluid flow path and a second fluid flow path, the flow control mechanism including a first sealing member and a second sealing member disposed and configured to define the first fluid flow path an the second fluid flow path;

a fluid reservoir at least partially defined by the flow control mechanism and configured to receive and isolate a first volume of bodily-fluid withdrawn from the patient; and

an actuator operably coupled to the flow control mechanism and configured to move the first sealing member a first distance to form a negative pressure in the fluid reservoir,

the actuator further configured to move the first sealing member and the second sealing member a second distance to move the flow control mechanism 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 fluid flow path and to the fluid reservoir, to a second configuration, in which the fluid reservoir is fluidically isolated from the inlet port.

10. The apparatus of claim 9, further comprising:

an outlet port configured to be fluidically coupled to a sample reservoir.

11. The apparatus of claim 10, wherein the outlet port is fluidically isolated from the fluid reservoir.

12. The apparatus of claim 10, wherein the inlet port is placed in fluid communication with the outlet port in the second configuration such that the bodily fluid can flow from the inlet port, through the second fluid flow path and to the outlet port.

13. The apparatus of claim 9, wherein the fluid reservoir is defined at least in part by the first sealing member and the second sealing member.

14. The apparatus of claim 9, wherein the flow control mechanism includes a first control member coupled to the first sealing member and a second control member coupled to the second sealing member, the first control member configured to move the first sealing member the first distance when the actuator is actuated by the user, and the second control member configured to move the second sealing member the second distance after the first control member has moved the first sealing member the first distance.

15. An apparatus comprising:

an inlet port configured to be fluidically coupled to a patient;

a flow control mechanism fluidically coupled to the inlet port, the flow control mechanism including a first control member operably coupled to a first sealing member and a second control member operably coupled to a second sealing member, the flow control mechanism operable to selectively control fluid flow between the inlet port and a fluid reservoir defined at least in part by the first sealing member and the second sealing member, the flow control mechanism having a first configuration such that fluid communication is established between the inlet port and the fluid reservoir, and a second configuration such that the fluid reservoir is fluidically isolated from the inlet port; and

an actuator operably coupled to the flow control mechanism and configured to move the first control member and the first sealing member a first distance to allow the bodily-fluid to flow from the inlet port to the fluid reservoir,

the actuator further configured to move the second control member and the second sealing member a second distance to place the flow control mechanism in the second configuration.

16. The apparatus of claim 15, wherein the movement of the first sealing member the first distance forms a negative pressure in the fluid reservoir.

17. The apparatus of claim 15, further comprising:

an outlet port configured to be fluidically coupled to a sample reservoir.

18. The apparatus of claim 17, wherein the inlet port is placed in fluid communication with the outlet port in the second configuration.

19. The device of claim 17, wherein the inlet port is axially offset from the outlet port such that the second sealing member fluidically isolates the inlet port from the outlet port in the first configuration.

20. The device of claim 17, wherein the second sealing member includes a first seal element and a second seal element spaced apart from the first seal element, the first seal element and the second seal element defining an annular void therebetween such that the bodily-fluid can flow from the inlet port, through the annular void and to the outlet port when the flow control mechanism is in the second configuration.