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

• US 9,872,645 B2
• Filed: 02/17/2017
• Issued: 01/23/2018
• 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:
  US15/435,684
• Publication Number:
  US 20170156654A1
• Time in Patent Office: 340 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 for obtaining a blood sample from a patient with reduced contamination, the sample procurement device including a needle configured for insertion into the patient, and a junction, the method comprising:

inserting the needle into the vasculature of the patient;

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

the sample procurement device configured to transition to a second state at the junction as a result of sequestration of an initial portion of the first volume of blood and to establish fluid communication between the needle and a sample vessel, the sample vessel containing culture media for facilitating growth of one or more types of microbes; and

receiving a second volume of blood into the sample vessel,

whereby sequestering the initial portion of the first volume of blood sequesters contaminants present in the first volume of blood, thereby reducing contamination that can lead to false positives in culture tests of the second volume of blood.

2. The method of claim 1, wherein the initial portion of blood is less than 5 ml.

3. The method of claim 1, wherein the initial portion of blood is sequestered in a reservoir.

4. The method of claim 3, wherein the reservoir is a vacuum-sealed reservoir.

5. The method of claim 1, 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.

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

20. The method of claim 1, wherein the amount of blood in the second volume of blood is based on a size of the sample vessel.

21. The method of claim 1, wherein the second volume of blood is approximately 2 ml to 10 ml of blood.

22. The method of claim 3, wherein the blood stops flowing from the patient when a pressure in the needle and a pressure in the reservoir equalizes.

23. The method of claim 1, wherein the second volume of blood is received into the sample vessel directly after the initial portion of the first volume of blood is sequestered.

7. A method of establishing a fluid flow path between a patient and a sample vessel using a sample procurement device, the sample procurement device including a needle configured for insertion into the patient, tubing configured to be fluidically coupled to the needle, and a diverter, the method comprising:

inserting the needle into the vasculature of the patient;

receiving a first volume of blood from the patient while the diverter is in a first state;

in response to blood flow from the patient stopping, automatically transitioning the diverter to a second state whereby an initial portion of the first volume of blood is sequestered and fluid communication is established between the needle and the tubing;

establishing fluid communication between the tubing and a sample vessel, the sample vessel containing culture media for facilitating growth of one or more types of microbes; and

receiving a second volume of blood into the sample vessel,

whereby sequestering the initial portion of blood sequesters contaminants present in the first volume of blood from the tubing, thereby reducing contamination that can lead to false positives in culture tests of the second volume of blood.

8. The method of claim 7, wherein the initial portion of blood is less than 5 ml.

9. The method of claim 7, wherein the initial portion of blood is sequestered in a reservoir.

10. The method of claim 9, wherein the reservoir is integrated into the sample procurement device.

11. The method of claim 7, wherein the needle is a first needle, the tubing configured to be fluidically coupled to a second needle, the second needle being removably insertable into the sample vessel.

12. The method of claim 7, wherein the contaminants are dermally-residing microbes.

24. The method of claim 7, wherein the amount of blood in the second volume of blood is based on a size of the sample vessel.

25. The method of claim 7, wherein the second volume of blood is approximately 2 ml to 10 ml of blood.

26. The method of claim 9, wherein the blood stops flowing from the patient when a pressure in the needle and a pressure in the reservoir equalizes.

13. A method of establishing a fluid flow path between a patient and a sample vessel using a sample procurement device, the sample procurement device including a needle configured for insertion into the patient, and a flow controller configured to be fluidically coupled to the needle, the flow controller defining a first fluid flow path and a second fluid flow path, the method comprising:

inserting the needle into the vasculature of the patient;

establishing fluid communication between the needle and the first fluid flow path;

receiving a first volume of blood from the patient;

allowing the first volume of blood to flow to the first fluid flow path;

after pressure substantially equalizes, automatically sequestering the first volume of blood in at least the portion of the first fluid flow path;

establishing fluid communication between the needle and a sample vessel, the sample vessel containing culture media for facilitating growth of one or more types of microbes; and

allowing a second volume of blood to flow from the needle, through the second fluid flow path, and to the sample vessel,

whereby sequestering the first volume of blood sequesters contaminants present in the first volume of blood from the second fluid flow path, thereby reducing contamination that can lead to false positives in culture tests of the second volume of blood.

14. The method of claim 13, wherein the contaminants are dermally-residing microbes.

15. The method of claim 13, wherein the sample procurement device includes input tubing configured to fluidically couple the needle to the flow controller.

16. The method of claim 13, wherein the sample procurement device includes output tubing configured to fluidically couple the second fluid flow path of the flow controller to the sample vessel.

17. The method of claim 13, wherein the first volume of blood is less than 5 ml.

18. The method of claim 13, wherein the first volume of blood is sequestered in a reservoir.

19. The method of claim 18, wherein the reservoir is integrated into the sample procurement device.

27. The method of claim 13, wherein the amount of blood in the second volume of blood is based on a size of the sample vessel.

28. The method of claim 13, wherein the second volume of blood is approximately 2 ml to 10 ml of blood.

29. The method of claim 18, wherein the blood stops flowing from the patient when a pressure in the needle and a pressure in the first fluid flow path equalizes.

30. A method of using a sample procurement device for obtaining a blood sample from a patient with reduced contamination, the sample procurement device including a lumen-containing device configured to establish fluid communication with the patient, and a junction, the method comprising:

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

receiving an initial flow of blood from the patient while the sample procurement device is in a first state;

the sample procurement device configured to transition to a second state at the junction as a result of sequestering an initial volume of blood and any contaminants present therein and to establish fluid communication between the lumen-containing device and a sample vessel, the sample vessel containing culture media for facilitating growth of one or more types of microbes; and

receiving approximately 2 ml to 10 ml of sample blood into the sample vessel.