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

• US 9,861,306 B2
• Filed: 03/03/2017
• Issued: 01/09/2018
• 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:
  US15/448,891
• Publication Number:
  US 20170172482A1
• Time in Patent Office: 312 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 lumen-containing device configured to be fluidically coupled to a patient;

a reservoir configured to be fluidically coupled to the lumen-containing device and to receive an initial volume of bodily fluid withdrawn from the patient; and

a diverter fluidically coupled to the lumen-containing device and operable to control fluid flow between the lumen-containing device and at least one of the reservoir and a sample reservoir, the diverter having a first state such that fluid communication is established between the lumen-containing device and the reservoir, and a second state such that fluid communication is established between the lumen-containing device and the sample reservoir,

the diverter configured to transition to the second state as a result of receiving the initial volume of bodily fluid in the reservoir and after pressure substantially equalizes, thereby sequestering in the reservoir contaminants present in the initial volume of bodily fluid and reducing contamination of a 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 lumen-containing device.

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 1, wherein the initial volume of bodily fluid is approximately 0.5 ml to 3 ml.

6. 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 lumen-containing device to the reservoir in the first state, and a second fluid flow path that allows a subsequent volume of bodily fluid to flow from the lumen-containing device to the sample reservoir in the second state.

7. The apparatus of claim 1, wherein the diverter is configured to transition from the first state to the second state when bodily fluid stops flowing to the diverter.

8. The apparatus of claim 1, wherein the diverter is configured to transition from the first state to the second state when bodily fluid stops flowing to the reservoir.

9. 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;

an input tube fluidically coupled to the needle;

a diverter fluidically coupled to the input tube;

a reservoir configured to receive and sequester an initial volume of bodily fluid withdrawn from the patient; and

an output tube fluidically coupled to the diverter,

the diverter operable in a first state such that fluid communication is established between the input tube and the reservoir such that the initial volume of bodily fluid can flow from the input tube into the reservoir until pressure substantially equalizes, and in a second state such that fluid communication is established between the input tube and the output tube,

the diverter configured to automatically transition to the second state 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.

10. The apparatus of claim 9, wherein the needle is a first needle, the apparatus further comprising a second needle fluidically coupleable to the output tube.

11. The apparatus of claim 9, wherein the initial volume of bodily fluid is greater than the lumen of the needle and less than 5 ml.

12. The apparatus of claim 9, wherein the diverter defines a first fluid flow path that allows the initial volume of bodily fluid to flow from the input tube to the reservoir in the first state, and a second fluid flow path that allows a subsequent volume of bodily fluid to flow from the input tube to the output tube in the second state.

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

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

an output tube configured to be fluidically coupled to the first needle; and

an intermediary lumen-containing device configured to establish fluid communication between the first needle and the output tube, the intermediary lumen-containing device configured to transfer an initial volume of bodily fluid from the first needle to a pre-sample reservoir when in a first state, the initial volume of bodily fluid being (a) greater than the volume of the lumen of the first needle, and (b) less than 5 ml, the intermediary lumen-containing device configured to transfer a subsequent volume of bodily fluid to a sample reservoir via the output tube when in a second state, the intermediary lumen-containing device configured to transition from the first state to the second state in response to receiving the initial volume of bodily fluid in the pre-sample reservoir and after pressure substantially equalizes,

whereby transferring the initial volume of bodily fluid to the pre-sample reservoir sequesters contaminants present in the initial volume of bodily fluid thereby reducing contamination of the subsequent volume of bodily fluid withdrawn from the patient.

14. The apparatus of claim 13, wherein the intermediary lumen-containing device defines a first fluid flow path that allows the initial volume of bodily fluid to flow from the first needle to the pre-sample reservoir in the first state, and a second fluid flow path that allows the subsequent volume of bodily fluid to flow from the first needle tube to the output tube in the second state.

15. The apparatus of claim 13, wherein the pre-sample reservoir is integrated into the intermediary lumen-containing device.

16. The apparatus of claim 13, wherein the intermediary lumen-containing device includes an outlet and the output tube is fluidically coupled to the outlet.

17. The apparatus of claim 13, wherein the intermediary lumen-containing device includes a diverter configured to be automatically transitioned from the first state to the second state.

18. The apparatus of claim 13, wherein the intermediary lumen-containing device is configured to transition from the first state to the second state when bodily fluid stops flowing to the intermediary lumen-containing device.

19. The apparatus of claim 13, wherein the intermediary lumen-containing device is configured to transition from the first state to the second state when bodily fluid stops flowing to the pre-sample reservoir.

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

a first lumen-containing device configured to be fluidically coupled to a patient;

an output lumen-containing device configured to be fluidically coupled to the first lumen-containing device; and

an intermediary lumen-containing device configured to establish fluid communication between the first lumen-containing device and the output lumen-containing device, the intermediary lumen-containing device including a reservoir configured to receive an initial volume of bodily fluid withdrawn from the patient,

the intermediary lumen-containing device configured to transfer the initial volume of bodily fluid from the first lumen-containing device to the reservoir when in a first state, the intermediary lumen-containing device configured to transfer a subsequent volume of bodily fluid to the output lumen-containing device when in a second state,

the intermediary lumen-containing device configured to transition to the second state when pressure substantially equalizes and bodily fluid stops flowing from the patient, and to sequester in the reservoir contaminants present in the initial volume of bodily fluid, whereby transferring the initial volume of bodily fluid to the reservoir sequesters contaminants present in the initial volume of bodily fluid thereby reducing contamination of the subsequent volume of bodily fluid withdrawn from the patient.

21. The apparatus of claim 20, wherein the first lumen-containing device is a needle having a lumen configured for insertion into the patient.

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 greater than the lumen of the needle and less than 5 ml.

24. The apparatus of claim 20, wherein the intermediary lumen-containing device defines a first fluid flow path that allows the initial volume of bodily fluid to flow from the first lumen-containing device to the reservoir in the first state, and a second fluid flow path that allows the subsequent volume of bodily fluid to flow from the first lumen-containing device to the output lumen-containing device in the second state.

25. The apparatus of claim 20, wherein the intermediary lumen-containing device is configured to transition from the first state to the second state when bodily fluid stops flowing to the intermediary lumen-containing device.

26. The apparatus of claim 20, wherein the intermediary lumen-containing device is configured to transition from the first state to the second state when bodily fluid stops flowing to the reservoir.