Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination

• US 8,876,734 B2
• Filed: 11/25/2013
• Issued: 11/04/2014
• Est. Priority Date: 12/18/2006
• Status: Active Grant

• Current Assignee: Magnolia Medical Technologies Limited
• Original Assignee: Magnolia Medical Technologies Limited
• Inventors: Patton, Richard G.
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US14/089,267
• Publication Number:
  US 20140081172A1
• Time in Patent Office: 344 Days
• Field of Search: 600/573, 600575-580, 600/583, 604/317, 604/319, 604/320, 604/321, 604/322, 604/323, 604/324, 604/326, 604/540, 604/541
• US Class Current: 600/575
• 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 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• 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 5/1422 provided with indicating means, e.g. for vein entry
• 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 5/150251 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 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes 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 5/150503 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• 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 5/154 : Devices using pre-evacuated means
• CPC Class Codes: A61B 5/1545 : comprising means for indicating vein or arterial entry
• 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 2200/026 : Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/141 : Preventing contamination, tampering
• CPC Class Codes: B01L 2300/0672 : Integrated piercing tool
• CPC Class Codes: B01L 2400/082 : Active control of flow resistance, e.g. flow controllers
• CPC Class Codes: B01L 3/502 : with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00

Abstract

The present invention is directed to the parenteral procurement of bodily-fluid samples. The present invention is also directed to systems and methods for parenterally procuring bodily-fluid samples with reduced contamination from dermally-residing microbes. In some embodiments, a bodily-fluid withdrawing system is used to withdraw bodily fluid from a patient for incubation in culture media in one or more sample vessels. Prior to withdrawing bodily fluid into the one or more sample vessels for incubation, an initial volume of withdrawn bodily fluid is placed in one or more pre-sample reservoirs and is not used for the incubation in culture media.

Claims

1. A method of establishing a fluid flow path between a patient and a fluid container, the method comprising:

establishing fluid communication between the patient and a lumen-containing device;

withdrawing a first volume of a bodily-fluid from the patient, the first volume of bodily-fluid being greater than the volume of the lumen-containing device and less than 5 ml;

transferring the first volume of bodily-fluid to a fluid reservoir via the lumen-containing device;

fluidically isolating the lumen-containing device from the fluid reservoir to sequester the first volume of bodily-fluid in the fluid reservoir; and

establishing fluid communication between the patient and the fluid container with the lumen-containing device,

whereby sequestering the first volume of bodily-fluid in the fluid reservoir sequesters microbes present in the first volume of bodily-fluid from the fluid flow path, thereby reducing contamination in the fluid flow path and any subsequent volumes of bodily-fluid withdrawn from the patient.

2. The method of claim 1, wherein the first volume of bodily-fluid is in the range of 1 ml to 5 ml.

3. The method of claim 1, wherein the first volume of bodily-fluid is in the range of 0.5 ml to 3 ml.

4. The method of claim 1, further comprising:

after the first volume of bodily-fluid has been sequestered in the fluid reservoir, receiving a second volume of bodily-fluid into the fluid container via the lumen-containing device.

5. The method of claim 4, wherein the fluid container is a first fluid container, the method further comprising:

establishing fluid communication between the patient and a second fluid container; and

receiving a third volume of bodily-fluid into the second fluid container via the lumen-containing device.

6. A method of establishing a fluid flow path between a patient and a fluid container using a fluid transfer device, the fluid transfer device including a lumen-containing device, a diversion mechanism, and a fluid reservoir fluidically coupleable to the lumen-containing device, the method comprising:

establishing fluid communication between the patient and the fluid reservoir;

receiving a first volume of a bodily-fluid into the fluid reservoir via the lumen-containing device while the diversion mechanism is in a first configuration, the first volume of bodily-fluid being greater than the volume of the lumen-containing device and less than 5 ml;

changing the diversion mechanism to a second configuration to fluidically isolate the lumen-containing device from the fluid reservoir such that the first volume of bodily-fluid is sequestered in the fluid reservoir, and

establishing fluid communication between the lumen-containing device and the fluid container,

whereby sequestering the first volume of bodily-fluid in the fluid reservoir sequesters dermally-residing microbes present in the first volume of bodily-fluid from the fluid flow path, thereby resulting in a reduction of (a) microbial contamination in the fluid flow path and (b) false results when testing a second volume of bodily-fluid subsequently transferred to the fluid container.

7. The method of claim 6, wherein the first volume of bodily-fluid is in the range of 0.5 ml to 3 ml.

8. The method of claim 6, wherein the lumen-containing device is configured to be fluidically coupled to the fluid container while the diversion mechanism is in the second configuration.

9. The method of claim 6, wherein the first volume of bodily-fluid is in the range of 1 ml to 5 ml.

10. The method of claim 6, wherein the fluid transfer device further including a needle having a lumen and configured for insertion into the patient and the first volume of a bodily-fluid is greater than the combined volumes of the lumen of the needle and the lumen-containing device.

11. The method of claim 10, wherein the needle is a first needle, the fluid transfer device further including a second needle having a lumen fluidically coupleable to the first needle, the second needle being removably insertable into the fluid container.

12. The method of claim 6, wherein the diversion mechanism includes a valve configured to be moved between a first position and a second position, the method further comprising:

disposing the valve in the first position prior to withdrawing the first volume of bodily-fluid from the patient, the first position of the valve corresponding to the first configuration of the diversion mechanism in which the patient and the fluid reservoir are in fluid communication.

13. The method of claim 12, further comprising:

after the first volume of bodily-fluid has been received in the fluid reservoir, moving the valve to the second position, the second position of the valve corresponding to the second configuration of the diversion mechanism in which the needle and the fluid container are in fluid communication.

14. The method of claim 12, wherein the valve is automatically moved from the first position to the second position after the first volume of bodily-fluid has been received in the fluid reservoir.

15. The method of claim 12, wherein the valve is electronically moved from the first position to the second position after the first volume of bodily-fluid has been received in the fluid reservoir.

16. A method of establishing a fluid flow path between a patient and a fluid container using a fluid transfer device, the fluid transfer device including a needle having a lumen and configured for insertion into a patient, and a lumen-containing device configured to fluidically couple the lumen of the needle to a fluid container, the method comprising:

inserting the needle into the patient;

transferring a first volume of bodily-fluid to a fluid reservoir via the needle and the lumen-containing device, the first volume of bodily-fluid being greater than the combined volumes of the lumen of the needle and the lumen-containing device and less than 5 ml;

fluidically isolating the lumen-containing device from the fluid reservoir to sequester the first volume of bodily-fluid in the fluid reservoir;

establishing fluid communication between the needle and the fluid container with the lumen-containing device; and

transferring a second volume of bodily-fluid to the fluid container via the needle and the lumen-containing device,

whereby sequestering the first volume of bodily-fluid in the fluid reservoir sequesters dermally-residing microbes present in the first volume of bodily-fluid from the fluid flow path, thereby reducing microbial contamination in (a) the fluid flow path and (b) the fluid container to reduce a probability of a false result when testing the second volume of bodily-fluid.

17. The method of claim 16, wherein the first volume of bodily-fluid is in the range of 1 ml to 5 ml.

18. The method of claim 16, wherein the first volume of bodily-fluid is in the range of 0.5 ml to 3 ml.

19. The method of claim 16, wherein the needle is a first needle, the fluid transfer device further including a second needle having a lumen fluidically coupleable to the first needle, the second needle being removably insertable into the fluid container.

20. The method of claim 16, wherein the fluid container is a sample vessel, the method further comprising:

establishing fluid communication between the needle and the sample vessel; and

receiving a second volume of bodily-fluid into the sample vessel.

21. The method of claim 20, wherein the sample vessel is a first sample vessel, the method further comprising:

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

receiving a third volume of bodily-fluid into the second sample vessel.

22. The method of claim 16, wherein the fluid transfer device further includes a diversion mechanism having a first configuration and a second configuration, the method further comprising:

disposing the diversion mechanism in the first configuration to establish fluid communication between the needle and the fluid reservoir prior to withdrawing the first volume of bodily-fluid from the patient.

23. The method of claim 22, further comprising:

moving the diversion mechanism to the second configuration to (a) fluidically isolate the needle from the fluid reservoir, and (b) establish fluid communication between the needle and the fluid container.

24. The method of claim 22, wherein the diversion mechanism is a single diversion mechanism.

25. A method of establishing a fluid flow path between a patient and a fluid container using a fluid transfer device, the fluid transfer device including a needle having a lumen and configured for insertion into the patient, a diversion mechanism, and a fluid reservoir fluidically coupleable to the needle, the method comprising:

inserting the needle into the patient;

disposing the diversion mechanism in a first configuration to establish fluid communication between the needle and the fluid reservoir;

withdrawing a first volume of a bodily-fluid from the patient via the needle, the first volume of bodily-fluid being greater than the volume of the lumen of the needle and less than 5 ml;

transferring the first volume of bodily-fluid to the fluid reservoir via the needle and the lumen-containing device; and

changing the diversion mechanism to a second configuration to (a) fluidically isolate the needle from the fluid reservoir such that the first volume of bodily-fluid is sequestered in the fluid reservoir and (b) establish fluid communication between the needle and the fluid container,

whereby sequestering the first volume of bodily-fluid in the fluid reservoir sequesters microbes present in the first volume of bodily-fluid, thereby reducing contamination in the fluid flow path and any subsequent volumes of bodily-fluid withdrawn from the patient.

26. The method of claim 25, wherein the first volume of bodily-fluid is in the range of 1 ml to 5 ml.

27. The method of claim 25, wherein the first volume of bodily-fluid is in the range of 0.5 ml to 3 ml.

28. The method of claim 25, wherein moving the diversion mechanism to the second configuration establishes fluid communication between the needle and the fluid container.

29. The method of claim 25, wherein the diversion mechanism includes a valve configured to be movable between a first position and a second position different than the first position, the first position of the valve corresponding to the first configuration of the diversion mechanism in which the needle and fluid reservoir are in fluid communication, the second position of the valve corresponding to the second configuration of the diversion mechanism in which the needle and the fluid container are in fluid communication.

30. The method of claim 29, wherein the valve is configured for translational movement between the first position and the second position.