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

• US 10,299,713 B2
• Filed: 09/26/2014
• Issued: 05/28/2019
• 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 J
• Application Number:
  US14/498,102
• Publication Number:
  US 20150094615A1
• Time in Patent Office: 1,705 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 bodily-fluid samples from a patient, the sample procurement device including a needle having a lumen configured for insertion into the patient, a first reservoir configured to be fluidically coupled to the needle via a first flow path, and a second reservoir configured to be fluidically coupled to the needle via a second flow path, the method comprising:

inserting the needle into the patient;

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

receiving from the patient a first volume of bodily-fluid into the first reservoir, the first volume of bodily-fluid being greater than the volume of the lumen of the needle and less than 5 ml;

as a result of filling the first reservoir, automatically establishing fluid communication between the needle and the second reservoir via the second flow path; and

receiving from the patient a second volume of bodily-fluid into the second reservoir,

whereby filling the first reservoir sequesters contaminants present in the first volume of bodily-fluid, thereby reducing contamination in the bodily-fluid received into the second reservoir.

2. The method of claim 1, further comprising:

after the first volume of bodily-fluid has been received into the first reservoir and before establishing fluid communication between the needle and the second reservoir, fluidically isolating the first reservoir from the needle.

3. The method of claim 2, whereby fluidically isolating the first reservoir from the needle sequesters microbes present in the first volume of bodily-fluid.

4. The method of claim 1, wherein the first reservoir is configured to be removably coupled to the sample procurement device.

5. The method of claim 1, further comprising:

establishing fluid communication between the second reservoir and a sample vessel; and

transferring at least a portion of the second volume of bodily-fluid from the second reservoir to the sample vessel.

6. The method of claim 5, wherein the bodily-fluid is blood and the sample vessel contains a culture media.

7. The method of claim 6, wherein the culture media is an aerobic culture media.

8. The method of claim 1, further comprising:

establishing fluid communication between the second reservoir and a first sample vessel;

transferring a first portion of the second volume of bodily-fluid from the second reservoir to the first sample vessel;

establishing fluid communication between the second reservoir and a second sample vessel; and

transferring a second portion of the second volume of bodily-fluid from the second reservoir to the second sample vessel.

9. The method of claim 8, wherein the bodily-fluid is blood and the first sample vessel contains an aerobic culture media and the second sample vessel contains an anaerobic culture media.

10. The method of claim 8, further comprising:

after the first portion of bodily-fluid has been transferred to the first sample vessel, fluidically isolating the second reservoir from the first sample vessel.

11. The method of claim 1, wherein the first flow path and the second flow path are connected with a junction.

12. The method of claim 1, wherein the second reservoir is a sample vessel.

13. The method of claim 12, wherein the bodily-fluid is blood and the sample vessel contains a culture media.

14. A method of obtaining a bodily-fluid sample from a patient with reduced contamination, the method comprising:

establishing fluid communication between the patient and a port of a sample procurement device, the sample procurement device including a first reservoir configured to be fluidically coupled to the needle via a first flow path and a second reservoir configured to be fluidically coupled to the needle via a second flow path, the first flow path and the second flow path connected at a junction;

establishing fluid communication between the port and the first reservoir via the first flow path;

receiving from the patient a first volume of bodily-fluid into the first reservoir;

as a result of filling the first reservoir, automatically sequestering the first volume of bodily-fluid in the first reservoir;

establishing fluid communication between the port and the second reservoir via the second flow path; and

receiving from the patient a second volume of bodily-fluid into the second reservoir,

whereby sequestering the first volume of bodily-fluid sequesters contaminants present in the first volume of bodily-fluid, thereby reducing contamination in the bodily-fluid received into the second reservoir.

15. The method of claim 14, wherein the sample procurement device includes a needle having a lumen fluidically coupled to the port, the method further comprising:

inserting the needle into the patient to establish fluid communication between the patient and the port of the sample procurement device.

16. The method of claim 15, wherein the first volume of bodily-fluid is greater than the volume of the lumen of the needle and less than 5 ml.

17. The method of claim 14, wherein the first reservoir is configured to be removably coupled to the sample procurement device.

18. The method of claim 14, further comprising:

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

transferring at least a portion of the second volume of bodily-fluid from the second reservoir to the sample vessel.

19. The method of claim 14, wherein the second reservoir is a sample vessel.

20. The method of claim 19, wherein the bodily-fluid is blood and the sample vessel contains a culture media.

21. A method of obtaining a bodily-fluid sample from a patient with reduced contamination, the method comprising:

establishing fluid communication between the patient and a sample procurement device with a lumen-containing device, the sample procurement device including a first reservoir and a second reservoir;

receiving from the patient a first volume of bodily-fluid into the first reservoir via a first flow path;

as a result filling the first reservoir, automatically sequestering the first volume of bodily-fluid in the first reservoir, the first volume of bodily-fluid being greater than the volume of the lumen-containing device and less than 5 ml;

establishing fluid communication between the lumen-containing device and the second reservoir via a second flow path;

receiving from the patient a second volume of bodily-fluid into the second reservoir; and

transferring at least a portion of the second volume of bodily-fluid from the second reservoir to a sample vessel,

whereby sequestering the first volume of bodily-fluid sequesters contaminants present in the first volume of bodily-fluid, thereby reducing contamination in the bodily-fluid received into the second reservoir.

22. The method of claim 21, wherein the bodily-fluid is blood and the sample vessel contains a culture media.

23. The method of claim 21, wherein the sample vessel is a first sample vessel, the method further comprising:

transferring at least a portion of the second volume of bodily-fluid from the second reservoir to a second sample vessel.

24. The method of claim 23, wherein the first sample vessel contains an aerobic culture media and the second sample vessel contains an anaerobic culture media.

25. The method of claim 21, wherein the first reservoir is configured to be removably coupled to the sample procurement device.

26. The method of claim 21, wherein the first flow path and the second flow path are connected with a junction.

27. The method of claim 21, wherein the second reservoir is a reservoir of a syringe.

28. The method of claim 27, wherein the bodily-fluid is blood and the sample vessel contains a culture media.

29. A method of using a sample procurement device for obtaining bodily-fluid samples from a patient, the sample procurement device including a lumen-containing device configured to establish fluid communication with the patient, a first reservoir configured to be fluidically coupled to the lumen-containing device via a first flow path, and a second reservoir configured to be fluidically coupled to the lumen-containing device via a second flow path, the first reservoir and the second reservoir being connected at a junction, the method comprising:

establishing fluid communication between the patient and the first reservoir via the lumen-containing device and the first flow path;

receiving from the patient a first volume of bodily-fluid into the first reservoir;

as a result of filling the first reservoir, automatically establishing fluid communication between the patient and the second reservoir via the lumen-containing device and second flow path; and

receiving from the patient a second volume of bodily-fluid into the second reservoir,

whereby filling the first reservoir sequesters contaminants present in the first volume of bodily-fluid, thereby reducing contamination in the bodily-fluid received into the second reservoir.

30. The method of claim 29, wherein the first volume of bodily-fluid is greater than the volume of the lumen of the lumen-containing device and less than 5 ml.

31. The method of claim 29, wherein the first reservoir is configured to be removably coupled to the sample procurement device.

32. The method of claim 29, further comprising:

establishing fluid communication between the second reservoir and a sample vessel; and

transferring at least a portion of the second volume of bodily-fluid from the second reservoir to the sample vessel.

33. The method of claim 32, wherein the second reservoir is a reservoir of a syringe.

34. The method of claim 32, wherein the sample vessel contains an aerobic culture media.

35. The method of claim 32, wherein the sample vessel contains an anaerobic culture media.

36. The method of claim 29, wherein the second reservoir is a sample vessel.

37. The method of claim 36, wherein the bodily-fluid is blood and the sample vessel contains a culture media.

38. The method of claim 29, wherein filling the first reservoir automatically sequesters the first volume of bodily-fluid in the first reservoir.