SYSTEMS AND METHODS FOR PARENTERALLY PROCURING BODILY-FLUID SAMPLES WITH REDUCED CONTAMINATION

• US 20080145933A1
• Filed: 12/13/2007
• Published: 06/19/2008
• 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.
• Granted Patent: US 8,197,420 B2
• Time in Patent Office: Days
• US Class Current: 435/379
• 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 system for parenterally procuring bodily-fluid samples from a patient with minimal contamination, the system comprising:

a bodily-fluid withdrawing device, the bodily-fluid withdrawing device comprising

a first sterile needle configured and arranged for insertion into a patient, the first sterile needle comprising a first lumen configured and arranged for withdrawing patient bodily fluids and passing the withdrawn bodily fluids through the first lumen,

a second sterile needle in fluid communication with the first sterile needle, the second sterile needle comprising a second lumen configured and arranged for passing withdrawn bodily fluids through the second lumen, and

at least one vacuum-sealed pre-sample reservoir, each of the at least one vacuum-sealed pre-sample reservoirs configured and arranged for collecting and storing patient bodily fluid withdrawn from the bodily-fluid withdrawing device; and

at least one vacuum-sealed sample vessel, each of the at least one vacuum-sealed sample vessels configured and arranged for collecting and storing patient bodily fluid withdrawn from the bodily-fluid withdrawing device, each of the at least one sample vessels containing a culture medium.

2. The system of claim 1, wherein each of the at least one vacuum-sealed pre-sample reservoirs defines a first mouth with a first septum covering the first mouth, the first septum providing an airtight seal to facilitate the maintenance of a vacuum in the at least one vacuum-sealed pre-sample reservoir.

3. The system of claim 2, wherein the second sterile needle comprises a distal end, the distal end configured and arranged to pass through the first septum and deposit withdrawn patient bodily fluids into each of the at least one vacuum-sealed pre-sample reservoirs.

4. The system of claim 1, wherein each of the at least one vacuum-sealed sample vessels defines a second mouth with a second septum covering the second mouth, the second septum providing an airtight seal to facilitate the maintenance of a vacuum in the at least one vacuum-sealed sample vessel.

5. The system of claim 4, wherein the second sterile needle comprises a distal end, the distal end configured and arranged to pass through the second septum and deposit withdrawn patient bodily fluids into each of the at least one vacuum-sealed sample vessels.

6. The system of claim 1, wherein the bodily-fluid withdrawing device further includes a flexible, sterile tubing with an input end and an output end, the input end coupled to the first lumen of the first sterile needle and the output end coupled to the second lumen of the second sterile needle.

7. The system of claim 1, wherein the bodily-fluid withdrawing device further includes a flexible, sterile tubing with an input end and an output end, the input end coupled to the first lumen of the first sterile needle and the output end coupled to a diversion mechanism, the diversion mechanism also coupled to the second lumen of the second sterile needle.

8. The system of claim 7, wherein the diversion mechanism is in fluid communication with the at least one pre-sample reservoir.

9. The system of claim 8, wherein the diversion mechanism is in fluid communication with the at least one pre-sample reservoir via a first output tubing.

10. The system of claim 8, wherein the diversion mechanism is coupled to the second sterile needle via a second output tubing.

11. The system of claim 8, wherein the diversion mechanism comprises a pivotable valve, the pivotable valve configured and arranged pivot between a first position and a second position, the first position placing the pivotable valve so that withdrawn bodily fluids pass from the flexible, sterile tubing to the at least one pre-sample reservoir, the second position placing the pivotable valve so that withdrawn bodily fluids pass from flexible, sterile tubing to the second sterile needle.

12. The system of claim 8, wherein the diversion mechanism comprises an input flow-control block and an output flow-control block slidably-mounted to the input flow-control block, the input flow-control block comprising an input lumen with an input end and an output end, the input end coupled to the flexible-sterile tubing, the output end extending to the output flow-control block.

13. The system of claim 12, wherein the output flow-control block comprises a first output lumen and a second output lumen, the first output lumen and the second output lumen each having an input end and an output end, the input end of both the first output lumen and the second output lumen extending from the input flow-control block, the output end of the first output lumen in fluid communication with the at least one pre-sample reservoir, the output end of the second output lumen in fluid communication with the at least one sample vessel.

14. The system of claim 13, wherein the input flow-control block and the output flow-control block are configured and arranged to slide between a first position and a second position, the first position aligning the input lumen of the input flow-control block with the first output lumen of the output flow-control block, the second position aligning the input lumen of the input flow-control block with the second output lumen of the output flow-control block.

15. A method for parenterally procuring bodily-fluid samples from a patient with reduced contamination, the method comprising:

inserting a first sterile needle of a bodily-fluid withdrawing device into a selected bodily-fluid-containing portion of the patient, the bodily-fluid withdrawing device also comprising a second sterile needle in fluid communication with the first sterile needle;

inserting the second sterile needle into a vacuum-sealed pre-sample reservoir and draining a predetermined amount of bodily fluids into the vacuum-sealed pre-sample reservoir;

removing the second sterile needle from the pre-sample reservoir;

inserting the second sterile needle into a first vacuum-sealed sample vessel comprising a first culture medium; and

draining a predetermined amount of bodily fluids into the first vacuum-sealed sample vessel for incubation in the first culture medium.

16. The method of claim 15, further including removing the second sterile needle from the first vacuum-sealed sample vessel and subsequently inserting the second sterile needle into a second vacuum-sealed sample vessel comprising a second culture medium.

17. A method for parenterally procuring bodily-fluid samples from a patient with reduced contamination, the method comprising:

inserting a first sterile needle of a bodily-fluid withdrawing device into a selected bodily-fluid-containing portion of the patient, the bodily-fluid withdrawing device comprising a diversion mechanism, a pre-sample reservoir, and a second sterile needle, the diversion mechanism configured and arranged for diverting withdrawn bodily fluids from the first sterile needle to either the second sterile needle or to the pre-sample reservoir;

inserting the second sterile needle into a first vacuum-sealed sample vessel;

adjusting the diversion mechanism to divert withdrawn patient bodily fluids to the pre-sample reservoir; and

adjusting the diversion mechanism to divert withdrawn patient bodily fluids to the first vacuum-sealed sample vessel.

18. The method of claim 17, further including removing the second sterile needle from the first vacuum-sealed sample vessel and subsequently inserting the second sterile needle into a second vacuum-sealed sample vessel.

19. The method of claim 17, wherein the diversion mechanism comprises a pivotable valve that pivots to divert withdrawn bodily fluids to one of

the pre-sample reservoir;

and

the first vacuum-sealed sample vessel.

20. The method of claim 17, wherein the diversion mechanism comprises an input flow-control block and an output flow-control block slidably-mounted to the input flow-control block, the output flow-control block slidable along the input flow-control block to divert withdrawn bodily fluids to one of

the pre-sample reservoir;

and

the first vacuum-sealed sample vessel.