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

• US 8,231,546 B2
• Filed: 12/22/2011
• Issued: 07/31/2012
• 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): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US13/335,241
• Publication Number:
  US 20120095367A1
• Time in Patent Office: 222 Days
• Field of Search: 600/573, 600/575, 600577-579
• US Class Current: 600/573
• 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 using a sample procurement device for obtaining one or more blood samples from a patient, the sample procurement device including a needle having a lumen configured for insertion into the patient, and a pre-sample reservoir fluidically coupleable to the needle, the method comprising the ordered steps of:

inserting the needle into the vasculature of the patient;

establishing fluid communication between the needle and the pre-sample reservoir;

receiving a first volume of blood into the pre-sample reservoir;

fluidically isolating the needle from the pre-sample reservoir;

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

receiving a second volume of blood subsequent to the first volume of blood into the sample vessel.

2. The method of claim 1, further comprising:

isolating the first volume of blood received in the pre-sample reservoir.

3. The method of claim 1, wherein the needle is a first needle, the sample procurement device further including a second needle having a lumen fluidically coupleable to the first needle, the second needle being removably insertable into the sample vessel.

4. The method of claim 3, wherein the sample vessel is a first sample vessel, the method further comprising:

inserting the second needle of the sample procurement device into a second sample vessel; and

receiving a third volume of blood into the second sample vessel.

5. The method of claim 1, wherein the sample procurement device further includes a diversion mechanism having a first configuration and a second configuration, the method further comprising:

moving the diversion mechanism to the first configuration to establish fluid communication between the needle and the pre-sample reservoir.

6. The method of claim 5, further comprising:

moving the diversion mechanism to the second configuration to establish fluid communication between the needle and the sample vessel and to fluidically isolate the needle from the pre-sample reservoir.

7. The method of claim 5, wherein the diversion mechanism is a single diversion mechanism.

8. The method of claim 1, wherein the pre-sample reservoir is integrated into the sample procurement device.

9. The method of claim 1, further comprising:

discarding the first volume of blood.

10. The method of claim 1, further comprising:

utilizing the first volume of blood for non-culture blood tests.

11. The method of claim 1, wherein the sample vessel includes a culture medium disposed therein for growing selected microbes.

12. The method of claim 1, wherein the first volume of blood received in the pre-sample reservoir is approximately 1 ml to 5 ml.

13. A method of using a sample procurement device for obtaining one or more blood samples from a patient, the sample procurement device including a first needle having a lumen configured for insertion into the patient, a second needle having a lumen fluidically coupleable to the first needle, and an integrated pre-sample reservoir fluidically coupleable to the first needle, the method comprising:

inserting the first needle of the sample procurement device into the vasculature of the patient;

inserting the second needle of the sample procurement device into a sample vessel;

fluidically isolating the first needle from the second needle;

establishing fluid communication between the first needle and the pre-sample reservoir;

receiving a first volume of blood into the pre-sample reservoir;

fluidically isolating the first needle from the pre-sample reservoir to sequester the first volume of blood;

discarding the first volume of blood or utilizing the first volume of blood for non-culture blood tests;

establishing fluid communication between the first needle and the second needle; and

receiving a second volume of blood into the sample vessel, the sample vessel having a culture medium disposed therein for growing selected microbes.

14. The method of claim 13, further comprising:

isolating the first volume of blood received in the pre-sample reservoir.

15. The method of claim 13, wherein the sample vessel is a first sample vessel, the method further comprising:

removing the second needle of the sample procurement device from the first sample vessel;

inserting the second needle of the sample procurement device into a second sample vessel; and

receiving a third volume of blood into the second sample vessel.

16. The method of claim 13, wherein the sample procurement device further includes a diversion mechanism having a first configuration and a second configuration, the method further comprising:

moving the diversion mechanism to the first configuration to establish fluid communication between the first needle and the pre-sample reservoir and to fluidically isolate the first needle from the second needle.

17. The method of claim 16, further comprising:

moving the diversion mechanism to the second configuration to establish fluid communication between the first needle and the second needle and to fluidically isolate the first needle from the pre-sample reservoir.

18. The method of claim 13, wherein the first needle is removably coupled to the sample procurement device.

19. The method of claim 13, wherein the sample procurement device further includes a single diversion mechanism having a first configuration and a second configuration.

20. A method of using a sample procurement device for obtaining one or more bodily fluid samples from a patient, the sample procurement device including a needle configured for insertion into the patient, a pre-sample reservoir fluidically coupled to the needle, and a single diversion mechanism operable to selectively control fluid flow between the needle and the pre-sample reservoir, the method comprising:

inserting the needle of the sample procurement device into the patient;

receiving a volume of bodily fluid into the pre-sample reservoir while the single diversion mechanism is in a first configuration;

moving the single diversion mechanism to a second configuration to isolate the volume of bodily fluid in the pre-sample reservoir and to establish fluid communication between the needle and a sample vessel; and

receiving a volume of bodily fluid into the sample vessel.

21. The method of claim 20, further comprising:

moving the diversion mechanism to a third configuration to prevent bodily fluid from flowing from the patient.

22. The method of claim 20, further comprising:

isolating the volume of bodily fluid received in the pre-sample reservoir.

23. The method of claim 22, wherein moving the diversion mechanism to the second configuration isolates the volume of bodily fluid received in the pre-sample reservoir.

24. The method of claim 20, wherein the volume of bodily fluid received in the pre-sample reservoir is approximately 1 ml to 5 ml.

25. A method of reducing contamination of a bodily fluid sample from a patient, comprising:

inserting a needle into the patient;

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

receiving a predetermined volume of bodily fluid into the pre-sample reservoir; and

after the predetermined volume of bodily fluid has been received into the pre-sample reservoir, automatically diverting flow of the bodily fluid to a sample vessel with a diversion mechanism

to isolate the pre-sample reservoir and sequester dermally residing microbes in the pre-sample reservoir.

26. The method of claim 25, wherein the predetermined volume of bodily fluid received in the pre-sample reservoir is approximately 1 ml to 5 ml.

27. The method of claim 25, further comprising:

receiving a predetermined volume of bodily fluid into the sample vessel.

28. The method of claim 25, wherein the predetermined volume of bodily fluid received in the pre-sample reservoir is a first volume of bodily fluid, the method further comprising:

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

29. The method of claim 25, further comprising:

discarding the predetermined volume of bodily fluid.

30. The method of claim 25, wherein the bodily fluid is blood, the method further comprising:

utilizing the predetermined volume of bodily fluid for non-culture blood tests.