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

• US 9,855,001 B2
• Filed: 03/13/2017
• 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:
  US15/457,082
• Publication Number:
  US 20170181683A1
• Time in Patent Office: 295 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 a bodily fluid sample from a patient with reduced contamination, the apparatus comprising:

a reservoir configured to receive an initial volume of bodily fluid withdrawn from the patient; and

a diverter having an inlet, a first outlet in fluid communication with the reservoir, and a second outlet, the inlet configured to be fluidically coupled to the patient, the diverter operable in a first operating mode in which an initial volume of bodily fluid can flow from the inlet to the first outlet, and a second operating mode in which;

a) a subsequent volume of bodily fluid can flow from the inlet to the second outlet, and b) the initial volume of bodily fluid is prevented from flowing to the second outlet,

the diverter configured to transition from the first operating mode to the second operating mode as a result of the initial volume of bodily fluid flowing from the patient and substantial pressure equalization, thereby sequestering in the reservoir contaminants present in the initial volume of bodily fluid, thereby reducing contamination of the subsequent volume of bodily fluid withdrawn from the patient.

2. The apparatus of claim 1, further comprising:

a needle having a lumen fluidically coupled to the inlet.

3. The apparatus of claim 2, wherein the initial volume of bodily fluid is greater than the lumen of the needle.

4. The apparatus of claim 2, wherein the initial volume of bodily fluid is greater than the lumen of the needle and less than 5 ml.

5. The apparatus of claim 2, wherein the diverter is configured to transition to the second operating mode after a pressure in the reservoir is substantially equal to a pressure in the lumen of the needle.

6. The apparatus of claim 1, wherein the initial volume of bodily fluid is approximately 0.5 ml to 5 ml.

7. The apparatus of claim 1, wherein the diverter defines a first fluid flow path that allows the initial volume of bodily fluid to flow from the inlet to the reservoir in the first operating mode, and a second fluid flow path that allows the subsequent volume of bodily fluid to flow from the inlet to the second outlet in the second operating mode.

8. An apparatus for obtaining a bodily fluid sample from a patient with reduced contamination, the apparatus comprising:

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

a reservoir configured to receive an initial volume of bodily fluid withdrawn from the patient; and

a diverter having an inlet, a first outlet and a second outlet, the inlet fluidically coupled to the needle and the first outlet coupled to the reservoir, the diverter operable in a first operating mode in which the inlet is fluidically coupled to the first outlet, and a second operating mode in which the inlet is fluidically coupled to the second outlet,

wherein the first operating mode allows bodily fluid to flow from the inlet and into the reservoir until a pressure in the lumen of the needle and a pressure in the reservoir substantially equalize, and

wherein the second operating mode;

a) allows bodily fluid to flow from the inlet and to the second outlet, and b) prevents bodily fluid from flowing from the reservoir to the second outlet,

the diverter configured to automatically transition from the first operating mode to the second operating mode when bodily fluid stops flowing from the patient, and to sequester in the reservoir contaminants present in the initial volume of bodily fluid, thereby reducing contamination of a subsequent volume of bodily fluid withdrawn from the patient.

9. The apparatus of claim 8, wherein the initial volume of bodily fluid is greater than the lumen of the needle.

10. The apparatus of claim 8, wherein the initial volume of bodily fluid is greater than the lumen of the needle and less than 5 ml.

11. The apparatus of claim 8, wherein the initial volume of bodily fluid is approximately 0.5 ml to 5 ml.

12. The apparatus of claim 8, wherein the needle is a first needle, the apparatus further comprising a second needle fluidically coupleable to the second outlet.

13. The apparatus of claim 8, wherein the first operating mode defines a first fluid flow path that allows the initial volume of bodily fluid to flow from the needle, to the inlet of the diverter, out the first outlet, and into the reservoir.

14. The apparatus of claim 13, wherein the second operating mode sequesters the initial volume of bodily fluid in the reservoir and defines a second fluid flow path that allows a subsequent volume of bodily fluid to flow from the needle, to the inlet of the diverter, and out the second outlet.

15. An apparatus for obtaining a bodily fluid sample from a patient with reduced contamination, the apparatus comprising:

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

a diverter fluidically coupled to the needle, the diverter including an inlet, a first outlet, and a second outlet, the diverter defining a first fluid flow path that allows an initial volume of bodily fluid to flow from the inlet to the first outlet, and a second fluid flow path that allows a subsequent volume of bodily fluid to flow from the inlet to the second outlet after the initial volume of bodily fluid has been diverted to the first fluid flow path and a pressure in the lumen of the needle and a pressure in the first fluid flow path substantially equalize,

the diverter configured to automatically divert the flow of bodily fluid through the second fluid flow path when bodily fluid stops flowing from the patient,

whereby diverting the initial volume of bodily fluid sequesters contaminants present in the initial volume of bodily fluid thereby reducing contamination of the subsequent volume of bodily fluid withdrawn from the patient through the second fluid flow path.

16. The apparatus of claim 15, wherein the initial volume of bodily fluid is greater than the lumen of the needle.

17. The apparatus of claim 15, wherein the initial volume of bodily fluid is greater than the lumen of the needle and less than 5 ml.

18. The apparatus of claim 15, wherein the initial volume of bodily fluid is approximately 0.5 ml to 3 ml.

19. The apparatus of claim 15, wherein the diverter sequesters the initial volume of bodily fluid in a portion of the first fluid flow path prior to the subsequent volume of bodily fluid flowing through the second fluid flow path.

20. The apparatus of claim 15, wherein the diverter sequesters the initial volume of bodily fluid in a reservoir prior to the subsequent volume of bodily fluid flowing through the second fluid flow path.

21. An apparatus for obtaining a bodily fluid sample from a patient with reduced contamination, the apparatus comprising:

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

a diverter fluidically coupled to the needle, the diverter including an inlet, an outlet, and a reservoir configured to receive an initial volume of bodily fluid withdrawn from the patient, the diverter defining a first fluid flow path that allows the initial volume of bodily fluid to flow from the patient until pressure substantially equalizes, and a second fluid flow path that allows a subsequent volume of bodily fluid to flow from the inlet to the outlet after the initial volume of bodily fluid has been sequestered, the diverter configured to divert the flow of bodily fluid to the second fluid flow path as a result of receiving the initial volume of bodily fluid from the patient and substantial pressure equalization,

whereby diverting the initial volume of bodily fluid sequesters contaminants present in the initial volume of bodily fluid thereby reducing contamination of the subsequent volume of bodily fluid withdrawn from the patient through the second fluid flow path.

22. The apparatus of claim 21, wherein the initial volume of bodily fluid is greater than the lumen of the needle.

23. The apparatus of claim 21, wherein the initial volume of bodily fluid is less than 5 ml.

24. The apparatus of claim 21, wherein the initial volume of bodily fluid is approximately 0.5 ml to 3 ml.

25. The apparatus of claim 21, further comprising:

a sample vessel fluidically coupled to the outlet of the diverter, the sample vessel containing at least one of aerobic culture media and anaerobic culture media.

26. The apparatus of claim 25, wherein the sample vessel is configured to receive at least a portion of the subsequent volume of bodily fluid.

27. The apparatus of claim 25, wherein the sample vessel is configured to receive about 2 ml to 10 ml of bodily fluid.

28. The apparatus of claim 21, further comprising:

a sample vessel fluidically coupleable to the outlet of the diverter, the sample vessel containing at least one of aerobic culture media and anaerobic culture media.

29. The apparatus of claim 21, wherein the diverter is configured to transition from a first state to a second state when bodily fluid stops flowing from the patient.