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

• US 9,855,002 B2
• Filed: 02/14/2017
• Issued: 01/02/2018
• 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:
  US15/432,310
• Publication Number:
  US 20170150913A1
• Time in Patent Office: 322 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 from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:

establishing fluid communication with the vasculature of the patient;

receiving a first volume of blood from the patient into the first fluid flow path when the junction is in a first state;

the junction configured to transition to a second state as a result of receiving the first volume of blood from the patient such that a portion of the first volume of blood is sequestered in the first fluid flow path; and

receiving a second volume of blood into a sample vessel via the second fluid flow path, the sample vessel containing a culture media,

whereby sequestering the portion of the first volume of blood sequesters contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.

2. 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, the portion of the first volume of blood is greater than a volume of the lumen of the needle and less than 5 ml.

3. 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, 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.

4. The method of claim 1, wherein the sample procurement device further includes a diverter having a first state operable to allow sequestration of contaminants present in the first volume of blood, and a second state operable to allow the second volume of blood to flow to the sample vessel, the transitioning at the junction includes the diverter transitioning from the first state to the second state after blood stops flowing from the patient.

5. The method of claim 4, wherein the diverter is a single diverter.

6. The method of claim 1, wherein the portion of blood is sequestered in a reservoir and not used for culture testing.

7. The method of claim 6, wherein the reservoir is integrated into the sample procurement device.

8. The method of claim 1, wherein the contaminants are dermally-residing microbes.

9. The method of claim 1, wherein the sample procurement device further includes a diverter that defines a first fluid flow path such that the portion of blood can flow from the needle to the sample procurement device, and a second fluid flow path such that the second volume of blood can flow from the needle to the sample vessel, the diverter configured to cause transition of blood flow from the first fluid flow path to the second fluid flow path after sequestration of the portion of blood flow from the patient.

10. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the sample procurement device defining a first fluid flow path and a second fluid flow path and having a junction, the method comprising:

establishing fluid communication with the vasculature of the patient;

receiving an initial volume of blood from the patient into a reservoir integrated into the sample procurement device via the first fluid flow path; and

the junction configured to transition to a second state in response to substantially filling the reservoir such that the initial volume of blood is sequestered in the reservoir and such that subsequent flow of blood flows to a sample vessel via the second fluid flow path, the sample vessel containing a culture media, the sequestered initial volume not being used as the blood sample in the culture testing,

whereby sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood, thereby reducing contamination in the blood flowing to the sample vessel to be used as the blood sample for the culture testing.

11. The method of claim 10, wherein the initial volume of blood is less than 5 ml.

12. The method of claim 10, 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.

13. The method of claim 10, wherein the initial volume of blood is 0.5 ml to 5 ml.

14. The method of claim 10, 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 to the sample vessel, the transitioning at the junction includes the diverter transitioning from the first state to the second state after blood stops flowing from the patient.

15. The method of claim 10, wherein the sample vessel is a vacuum-sealed vessel.

16. The method of claim 10, wherein the contaminants are dermally-residing microbes.

17. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the method comprising:

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

establishing fluid communication between the lumen-containing device and a first fluid flow path;

receiving an initial volume of blood from the patient;

transitioning at a junction between the first fluid flow path and a second fluid flow path as a result of the first fluid flow path receiving the initial volume of blood from the patient such that the initial volume of blood is sequestered and such that fluid communication is established between the lumen-containing device and a sample vessel via the second fluid flow path, the sample vessel containing a culture media; and

receiving a subsequent blood sample into the sample vessel.

18. The method of claim 17, whereby sequestering the initial volume of blood sequesters contaminants present in the initial volume of blood, thereby reducing contamination in the blood flowing to the sample vessel.

19. The method of claim 18, wherein the contaminants are dermally-residing microbes.

20. The method of claim 17, wherein the initial volume of blood is greater than a volume of the lumen of the lumen-containing device and less than 5 ml.

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

22. The method of claim 21, wherein the reservoir is integrated into the sample procurement device.

23. The method of claim 21, wherein the reservoir is configured to contain less than 5 ml of blood.

24. The method of claim 21, wherein the sample procurement device further includes a diverter that defines the first fluid flow path such that the initial volume of blood can flow from the lumen-containing device to the reservoir, and the second fluid flow path such that blood can flow from the lumen-containing device to the sample vessel.

25. The method of claim 17, wherein the sample procurement device further includes a diverter that transitions from a first state to a second state, the first state operable to transfer the initial volume of blood from the patient to a reservoir, the second state operable to sequester the initial volume of blood in the reservoir, the diverter configured to cause transition between the first state and the second state in response to the sequestration of the initial volume of blood flow from the patient.

26. The method of claim 17, wherein the sample procurement device further includes a diverter that transitions from a first state to a second state, the first state operable to transfer the initial volume of blood from the patient to a reservoir, the second state operable to establish fluid communication between the lumen-containing device and the sample vessel via the second fluid flow path.

27. The method of claim 17, wherein the sample procurement device further includes a diverter that transitions from a first state to a second state, the first state operable to transfer the initial volume of blood from the patient to a reservoir, the second state operable to (a) to sequester the initial volume of blood in the reservoir, and (b) establish fluid communication between the lumen-containing device and the sample vessel via the second fluid flow path.

28. A method of using a sample procurement device to obtain a blood sample from a patient with reduced contamination to reduce false results in culture testing of the blood sample, the method comprising:

inserting a lumen-containing device into the vasculature of the patient;

receiving a first volume of blood from the patient when a diverter of the sample procurement device is in a first state;

sequestering a portion of the first volume of blood as a result of receiving the first volume of blood;

after sequestering the portion of blood, establishing fluid communication between the lumen-containing device and a sample vessel, the sample vessel containing a culture media; and

receiving a second volume of blood into the sample vessel when the diverter is in a second state, the diverter configured to automatically transition from the first state to the second state after the first volume of blood stops flowing from the patient,

whereby sequestering the portion of the first volume of blood sequesters contaminants present in the first volume of blood, thereby reducing contamination in the second volume of blood used as the blood sample in the culture testing.