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

• US 10,028,688 B2
• Filed: 12/01/2017
• Issued: 07/24/2018
• 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:
  US15/829,018
• Publication Number:
  US 20180098723A1
• Time in Patent Office: 235 Days
• 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 to obtain a blood sample with reduced contamination from a patient, the method comprising:

establishing fluid communication with the vasculature of the patient and a first fluid flow path;

receiving an initial volume of blood from the patient;

in response to receiving the initial volume of blood from the patient, automatically sequestering the initial volume of blood in a reservoir integrated into the sample procurement device;

establishing fluid communication between the patient and a sample vessel, the sample vessel containing a culture media; and

receiving a second volume of blood into the sample vessel,

whereby sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood, thereby reducing contamination in the blood received into the sample vessel.

2. The method of claim 1, wherein the sample procurement device has a first state operable to allow sequestration of contaminants present in the initial volume of blood, and a second state operable to allow the second volume of blood to flow to a second fluid flow path, the sample procurement device configured to transition from the first state to the second state as a result of sequestering the initial volume of blood.

3. The method of claim 1, wherein the initial volume of blood sequestered in the reservoir is not used for culture testing.

4. The method of claim 1, wherein establishing fluid communication with the vasculature of the patient includes inserting a needle having a lumen into the vasculature of the patient.

5. The method of claim 1, wherein the initial volume of blood sequestered in the reservoir is less than 5 ml.

6. The method of claim 1, wherein the sample procurement device has a first state operable to allow the initial volume of blood to flow to the reservoir, and a second state operable to allow the second volume of blood to flow toward the sample vessel as a result of the initial volume of blood filling the reservoir.

7. The method of claim 1, wherein the initial volume of blood is fluidically isolated in the reservoir.

8. A method of using a sample procurement device to obtain a blood sample with reduced contamination from a patient, the method comprising:

establishing fluid communication between the vasculature of the patient and a first fluid flow path;

receiving an initial volume of blood from the patient into a reservoir integrated into the sample procurement device;

as a result of filling the reservoir, diverting flow away from the reservoir thereby sequestering the initial volume of blood in the reservoir;

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

receiving a second volume of blood into the sample vessel,

whereby sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood, thereby reducing contamination in the blood received into the sample vessel.

9. The method of claim 8, wherein the initial volume of blood is less than 5 ml.

10. The method of claim 9, wherein establishing fluid communication with the vasculature of the patient includes inserting a needle having a lumen into the vasculature of the patient, the initial volume of blood is greater than a volume of the lumen of the needle and less than 5 ml.

11. The method of claim 10, wherein the needle is a first needle, the sample procurement device configured to be fluidically coupled to a second needle, the second needle being removably insertable into the sample vessel.

12. The method of claim 8, wherein the sample procurement device further includes a diverter having a first state operable to allow sequestration of contaminants present in the initial volume of blood, and a second state operable to allow blood to flow toward the sample vessel.

13. The method of claim 8, wherein the sample procurement device automatically sequesters the initial volume of blood in the reservoir and diverts flow away from the reservoir as a result of filling the reservoir.

14. The method of claim 8, wherein the initial volume of blood is fluidically isolated in the reservoir.

15. The method of claim 8, wherein the sample vessel contains a culture media.

16. The method of claim 8, wherein the sample vessel is a syringe.

17. A method of using a sample procurement device to obtain a blood sample with reduced contamination from a patient, the method comprising:

establishing fluid communication between the vasculature of the patient and a first fluid flow path;

receiving an initial volume of blood from the patient;

sequestering the initial volume of blood in a reservoir integrated into the sample procurement device;

after blood stops flowing from the patient and the initial volume of blood is sequestered in the reservoir, establishing fluid communication between the needle and a sample vessel, the sample vessel containing a culture media; and

receiving a second volume of blood into the sample vessel,

whereby sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood, thereby reducing contamination in the blood received into the sample vessel.

18. The method of claim 17, wherein the initial volume of blood is less than 5 ml.

19. The method of claim 17, wherein the sample procurement device further includes a diverter having a first state operable to allow sequestration of contaminants present in the initial volume of blood, and a second state operable to allow blood to flow toward the sample vessel.

20. The method of claim 19, wherein the diverter automatically transitions from the first state to the second state as a result of filling the reservoir.

21. The method of claim 17, wherein the initial volume of blood is fluidically isolated in the reservoir.

22. The method of claim 17, wherein the sample vessel contains a culture media.

23. The method of claim 17, wherein the sample vessel is a syringe.

24. A method of using a sample procurement device to obtain a blood sample with reduced contamination from a patient, the method comprising:

establishing fluid communication between the vasculature of the patient and an inlet of the sample procurement device;

receiving an initial volume of blood from the patient into a reservoir integrated into the sample procurement device;

in response to filling the reservoir, sequestering the initial volume of blood in the reservoir;

establishing fluid communication between the patient and a sample vessel, the sample vessel containing a culture media; and

receiving a second volume of blood into the sample vessel.

25. The method of claim 24, wherein the sample procurement device has a first state operable to allow the initial volume of blood to flow to the reservoir, and a second state operable to allow the second volume of blood to flow toward the sample vessel as a result of the initial volume of blood filling the reservoir.

26. The method of claim 24, wherein the initial volume of blood sequestered in the reservoir is not used for culture testing.

27. The method of claim 24, wherein establishing fluid communication with the vasculature of the patient includes inserting a needle having a lumen into the vasculature of the patient.

28. The method of claim 24, wherein the initial volume of blood sequestered in the reservoir is less than 5 ml.

29. The method of claim 24, whereby sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood, thereby reducing contamination in the blood received into the sample vessel.

30. The method of claim 24, wherein the initial volume of blood is fluidically isolated in the reservoir.