Fluid diversion mechanism for bodily-fluid sampling

• US 8,535,241 B2
• Filed: 10/12/2012
• Issued: 09/17/2013
• Est. Priority Date: 10/13/2011
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: Patton, Richard G., Gaw, Shan, Miazga, Jay, Bullington, Gregory
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/650,554
• Publication Number:
  US 20130116599A1
• Time in Patent Office: 340 Days
• Field of Search: 600/573, 600/576, 600577-581, 604/27, 604/30, 604/33, 604/34, 604/246, 604/248, 604/249, 604/256
• US Class Current: 600/579
• 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 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 including a first sealing member and a second sealing member disposed in the housing and defining a first fluid flow path and a second fluid flow path;

a fluid reservoir disposed in the inner volume and at least partially defined by the flow control mechanism, the fluid reservoir 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 when actuated by a user, 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 inlet port is placed in fluid communication with the outlet port such that the bodily fluid can flow from the inlet, through the second fluid flow path and to the outlet.

2. The device of claim 1, wherein the outlet port is fluidically isolated from the fluid reservoir.

3. The device of claim 1, wherein the proximal end portion is substantially open.

4. The device of claim 1, wherein the distal end portion includes a vent.

5. The device of claim 1, wherein the fluid reservoir is defined at least in part by the first sealing member and the second sealing.

6. The device of claim 1, wherein the flow control mechanism includes a first control member coupled to a first sealing member and a second control member coupled to a second sealing member,

the first control member configured to move the first sealing member a first distance when the actuator is actuated by the user, and

the second control member configured to move the second sealing member a second distance after the first control member has moved the first sealing member the first distance.

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 and an outlet port;

a flow control mechanism movably disposed in the housing, 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 at least one of the outlet 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 fluid communication is established between the inlet port and the outlet 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 form a negative pressure in the fluid reservoir when actuated by a user, 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.

8. The device of claim 7, wherein the actuator is further configured to move the first sealing member and the second sealing member a second distance to place the flow control mechanism in the second configuration.

9. The device of claim 7, 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 position and fluidically couples the inlet port and the outlet port in second position.

10. The device of claim 7, wherein the inlet port is radially offset from the outlet port.

11. The device of claim 7, wherein the second sealing member includes a first seal element in contact with the housing and a second seal element spaced apart from the first seal element and in contact with the housing, the first seal element and the second seal element defining an annular void therebetween such that the bodily fluid can flow from the inlet, through the annular void and to the outlet when the flow control mechanism is in the second configuration.

12. The device of claim 11, wherein the second sealing member is slidably disposed on a control member, the control member configured to move the first sealing member when the actuator is actuated by the user.

13. The device of claim 12, wherein the second sealing member includes a third seal element in contact with the control member.