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

• US 8,647,286 B2
• Filed: 11/13/2012
• Issued: 02/11/2014
• 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): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/675,295
• Publication Number:
  US 20130079604A1
• Time in Patent Office: 455 Days
• Field of Search: 600/573, 600/575, 600/576, 600/577, 600/580, 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 obtaining a blood sample from a patient, the method comprising:

inserting a first needle into the patient;

inserting into a pre-sample reservoir a second needle fluidically coupleable to the first needle;

receiving a first volume of blood into the pre-sample reservoir, the first volume of blood in the range of 1 ml to 5 ml;

after the first volume of blood has been received into the pre-sample reservoir, removing the second needle from the pre-sample reservoir;

inserting the second needle into a first sample vessel containing at least one of aerobic culture media and anaerobic culture media; and

receiving a second volume of blood into the first sample vessel,

whereby receiving the first volume of blood into the pre-sample reservoir reduces false positives in culture tests of the second volume of blood.

2. The method of claim 1, further comprising:

after the second volume of blood has been received into the first sample vessel, removing the second needle from the first sample vessel.

3. The method of claim 2, further comprising:

inserting the second needle into a second sample vessel containing at least one of aerobic culture media and anaerobic culture media; and

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

4. The method of claim 3, further comprising:

after the third volume of blood has been received into the second sample vessel, removing the second needle from the second sample vessel.

5. The method of claim 4, further comprising:

removing the first needle from the patient.

6. The method of claim 1, further comprising:

causing the first sample vessel to be incubated at a temperature to facilitate growth of a tested microbe.

7. The method of claim 3, further comprising:

causing the first sample vessel to be incubated at a first temperature to facilitate growth of a first tested microbe; and

causing the second sample vessel to be incubated at a second temperature to facilitate growth of a second tested microbe.

15. The method of claim 1, wherein the second volume of blood is sufficient to grow microbes in a culture medium contained in the first sample vessel if microbes are present in the second volume of blood.

16. The method of claim 1, wherein the second volume of blood is in the range of 2 ml to 10 ml.

17. The method of claim 3, wherein the third volume of blood is in the range of 2 ml to 10 ml.

8. A method of obtaining blood samples from a patient, the method comprising the ordered steps of:

applying a disinfectant to a venipuncture site;

inserting a first needle into the venipuncture site;

inserting a second needle into a vacuum-sealed pre-sample reservoir;

transferring a first volume of blood into the vacuum-sealed pre-sample reservoir via the first needle and the second needle, the first volume of blood in the range of 1 ml to 5 ml;

removing the second needle from the vacuum-sealed pre-sample reservoir;

inserting the second needle into a first sample vessel containing at least one of aerobic culture media and anaerobic culture media;

transferring a second volume of blood into the first sample vessel;

removing the second needle from the first sample vessel;

inserting the second needle into a second sample vessel containing at least one of aerobic culture media and anaerobic culture media;

transferring a third volume of blood into the second sample vessel; and

removing the second needle from the second sample vessel.

9. The method of claim 8, further comprising:

after the first volume of blood has been transferred into the vacuum-sealed pre-sample reservoir, sequestering the first volume of blood for use in one or more non-culture tests.

10. The method of claim 8, further comprising:

causing the first volume of blood to be used for a non-culture blood test.

11. The method of claim 10, wherein the non-culture blood test includes at least one of a biochemical test, a blood count, an immunodiagnostic test, and a cancer-cell detection test.

12. The method of claim 8, wherein blood is transferred to the vacuum-sealed pre-sample reservoir until the pressure in the vacuum-sealed pre-sample reservoir is substantially equal to the vascular pressure of the patient at the venipuncture site.

13. The method of claim 8, further comprising:

causing the first sample vessel to be incubated at a temperature to facilitate growth of an aerobic microbe.

14. The method of claim 8, further comprising:

causing the second sample vessel to be incubated at a temperature to facilitate growth of an anaerobic microbe.

18. A method of using a sample procurement device for obtaining a blood sample from a patient, the sample procurement device including a first needle having a lumen and configured for insertion into the patient, a second needle having a lumen and configured for insertion into a sample vessel, and an intermediary lumen-containing device configured to fluidically couple the lumen of the first needle to the lumen of the second needle, the method comprising:

inserting the first needle into the patient;

inserting the second needle into a pre-sample reservoir;

receiving a first volume of blood into the pre-sample reservoir via the first needle, the second needle, and the intermediary lumen, the first volume of blood being greater than the combined volumes of the lumen of the first needle, the intermediary lumen containing device, and the lumen of the second needle, the first volume of blood in the range of 0.5 ml to 5 ml;

after the first volume of blood has been received into the pre-sample reservoir, removing the second needle from the pre-sample reservoir;

inserting the second needle into a first sample vessel containing at least one of aerobic culture media and anaerobic culture media; and

receiving a second volume of blood into the first sample vessel,

whereby receiving the first volume of blood into the pre-sample reservoir reduces false positives in culture tests of the second volume of blood.

19. The method of claim 18, wherein the first volume of blood is in the range of 0.5 ml to 3 ml.

20. The method of claim 18, wherein the first volume of blood is in the range of 1 ml to 5 ml.

21. The method of claim 18, whereby dermally residing microbes dislodged while inserting the first needle into the patient are transferred to and sequestered in the pre-sample reservoir.

22. The method of claim 18, whereby a tissue fragment dislodged while inserting the first needle into the patient is transferred to and sequestered in the pre-sample reservoir.

23. The method of claim 18, wherein the first volume of blood is not used for incubation in culture media.

24. A method of obtaining a blood sample from a patient, the method comprising:

establishing fluid communication between the vasculature of the patient and a pre-sample reservoir with a lumen-containing device;

receiving a first volume of blood into the pre-sample reservoir, the first volume of blood being greater than the volume of the lumen-containing device, the first volume of blood in the range of 0.5 ml to 5 ml;

fluidically isolating the lumen-containing device from the pre-sample reservoir to sequester the first volume of blood in the pre-sample reservoir;

after the first volume of blood has been sequestered in the pre-sample reservoir, establishing fluid communication between the vasculature of the patient and a sample vessel with the lumen-containing device, the sample vessel containing at least one of aerobic culture media and anaerobic culture media; and

receiving a second volume of blood into the sample vessel via the lumen-containing device,

whereby sequestering the first volume of blood into the pre-sample reservoir reduces false positives in culture tests of the second volume of blood.

25. The method of claim 24, wherein the first volume of blood is in the range of 0.5 ml to 3 ml.

26. The method of claim 24, wherein the first volume of blood is in the range of 1 ml to 5 ml.

27. The method of claim 24, wherein the first volume of blood is not used for incubation in culture media.

28. The method of claim 24, further comprising:

fluidically isolating the lumen-containing device from the vasculature of the patient after blood sample procurement is complete.

29. The method of claim 24, wherein the sample vessel is a first sample vessel, the method further comprising:

after the second volume of blood has been received into the first sample vessel, establishing fluid communication between the vasculature of the patient and a second sample vessel with the lumen-containing device, the second sample vessel containing at least one of aerobic culture media and anaerobic culture media; and

receiving a third volume of blood into the second sample vessel via the lumen-containing device.

30. The method of claim 27, further comprising:

after the third volume of blood has been received into the second sample vessel, establishing fluid communication between the vasculature of the patient and a third sample vessel with the lumen-containing device, the third sample vessel containing at least one of aerobic culture media and anaerobic culture media;

receiving a fourth volume of blood into the third sample vessel via the lumen-containing device;

after the fourth volume of blood has been received into the third sample vessel, establishing fluid communication between the vasculature of the patient and a fourth sample vessel with the lumen-containing device, the fourth sample vessel containing at least one of aerobic culture media and anaerobic culture media; and

receiving a fifth volume of blood into the fourth sample vessel via the lumen-containing device.