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

• US 10,028,689 B2
• Filed: 12/05/2017
• 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:
  US15/832,087
• Publication Number:
  US 20180092583A1
• Time in Patent Office: 231 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. An apparatus for obtaining biological fluid samples from a patient, the apparatus comprising:

a needle having a lumen configured for insertion into the patient;

an input tube fluidically coupled to the needle;

a junction having an inlet fluidically coupled to the input tube, a first outlet fluidically coupled to the inlet, and a second outlet fluidically coupled to the inlet;

a contaminant reservoir fluidically coupled to the first outlet of the junction; and

an output tube fluidically coupled to the second outlet of the junction,

the junction operable to allow an initial volume of biological fluid to flow from the patient to the contaminant reservoir, and to transition as a direct result of filling the contaminant reservoir to allow a subsequent volume of biological fluid to flow from the inlet to the second outlet.

2. The apparatus of claim 1, whereby filling the contaminant reservoir sequesters the initial volume of biological fluid in the contaminant reservoir and reduces contamination in the biological fluid flowing to the output tube.

3. The apparatus of claim 2, wherein the subsequent volume of biological fluid flowing to the output tube is substantially free of microbial artifacts.

4. The apparatus of claim 1, wherein the contaminant reservoir is integrated into the apparatus and is configured to receive less than 5 ml of biological fluid.

5. The apparatus of claim 1, wherein the junction transitions from a first state in which the initial volume of biological fluid can flow to the contaminant reservoir, to a second state in which the subsequent volume of biological fluid can flow to the second outlet.

6. The apparatus of claim 1, wherein all of the initial volume of the biological fluid from the patient flows into the contaminant reservoir.

7. The apparatus of claim 1, wherein the initial volume of biological fluid is fluidically isolated in the contaminant reservoir.

8. A biological fluid sequestration apparatus configured to be fluidically coupled to a sample vessel, the biological fluid sequestration apparatus comprising:

an inlet port fluidically coupled to a lumen-containing device; and

a contaminant reservoir and a sampling flow path, each of the contaminant reservoir and the sampling flow path fluidically coupled to the inlet port via a junction,

the contaminant reservoir and the junction being configured to direct a first portion of biological fluid into the contaminant reservoir,

the sampling flow path fluidically coupled to an outlet port, the sampling flow path and the junction being configured to transition without manual intervention as a direct result of filling the contaminant reservoir to allow a second portion of biological fluid to bypass the contaminant reservoir and to be directed into the sampling flow path toward the outlet port, the outlet port being fluidically coupled to the sample vessel.

9. The apparatus of claim 8, wherein the contaminant reservoir is integrated into the biological fluid sequestration apparatus.

10. The apparatus of claim 8, whereby filling the contaminant reservoir sequesters the first portion of biological fluid in the contaminant reservoir.

11. The apparatus of claim 8, whereby sequestering the first portion of biological fluid in the contaminant reservoir reduces contamination in the biological fluid flowing to the sampling flow path.

12. The apparatus of claim 8, wherein the second portion of biological fluid flowing to the sampling flow path is substantially free of microbial artifacts.

13. The apparatus of claim 8, wherein the first portion of biological fluid is less than 5 ml.

14. The apparatus of claim 8, wherein the junction transitions from a first state in which the first portion of biological fluid can flow to the contaminant reservoir, to a second state in which the second portion of biological fluid can flow to the sampling flow path.

15. The apparatus of claim 8, wherein all of the first portion of the biological fluid from the patient flows into the contaminant reservoir.

16. The apparatus of claim 8, wherein the first portion of biological fluid is fluidically isolated in the contaminant reservoir.

17. An apparatus for establishing a sampling flow path substantially free of microbial artifacts between a patient and a sample vessel, the apparatus comprising:

an input tube configured to be fluidically coupled to the patient;

an output tube configured to be fluidically coupled to the sample vessel;

a contaminant reservoir fluidically coupled to the input tube and the output tube; and

a junction disposed between the inlet tube and the output tube and fluidically coupled to the input tube, the output tube, and the contaminant reservoir,

the contaminant reservoir and the junction operable in a first state to allow a first portion of biological fluid to flow into the contaminant reservoir,

the contaminant reservoir and the junction operable in a second state to (a) sequester the first portion of biological fluid in the contaminant reservoir, and (b) to allow a second portion of biological fluid to bypass the contaminant reservoir and to flow to the output tube,

the contaminant reservoir and the junction operable to transition to the second state without manual intervention as a direct result of filling the contaminant reservoir.

18. The apparatus of claim 17, wherein the first portion of biological fluid is less than 5 ml.

19. The apparatus of claim 17, whereby sequestering the first portion of biological fluid in the contaminant reservoir reduces contamination in the biological fluid flowing to the output tube.

20. The apparatus of claim 17, whereby sequestering the first portion of biological fluid in the contaminant reservoir establishes the sampling flow path between the patient and the output tube that is substantially free of microbial artifacts.

21. The apparatus of claim 17, wherein all of the first portion of the biological fluid from the patient flows into the contaminant reservoir.

22. The apparatus of claim 17, wherein the first portion of biological fluid is fluidically isolated in the contaminant reservoir.

23. An apparatus for obtaining biological fluid samples from a patient, the apparatus comprising:

a needle having a lumen configured for insertion into the patient;

an input tube fluidically coupled to the needle;

a diverter including a reservoir and a junction configured to control fluid flow from the patient, the junction including an inlet fluidically coupled to the input tube, a first outlet fluidically coupled to the reservoir, and a second outlet fluidically coupled to an output tube,

the junction configured to (a) allow an initial volume of biological fluid to flow from the patient towards the first outlet, and (b) transition without manual intervention as a direct result of receiving the initial volume of biological fluid from the patient to allow a subsequent volume of biological fluid to bypass the initial volume of biological fluid sequestered in the reservoir and to flow to the output tube via the second outlet.

24. The apparatus of claim 23, wherein the initial volume of biological fluid is less than 5 ml.

25. The apparatus of claim 23, wherein the diverter is configured to transition at the junction from a first state to a second state, the first state operable to allow the initial volume of biological fluid to flow into the reservoir, the second state operable to (a) sequester the initial volume of biological fluid in the reservoir, and (b) establish fluid communication between the needle and the output tube.

26. The apparatus of claim 23, wherein the diverter is configured to transition from a first state to a second state as a result of filling the reservoir.

27. The apparatus of claim 23, wherein the reservoir is integrated into the diverter.

28. The apparatus of claim 23, wherein all of the initial volume of the biological fluid from the patient flows into the reservoir.

29. The apparatus of claim 23, wherein the initial volume of biological fluid is fluidically isolated in the reservoir.