ROTATABLE DISK-SHAPED FLUID SAMPLE COLLECTION DEVICE

• US 20140275866A1
• Filed: 03/13/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Original Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Inventors: Gunnerson, Kory A., Jakubowicz, Raymond F., Kirsch, Andrew M., Robinson, James Ellis, Salotto, Daniel P., Tomasso, David A., Ding, Zhong, Gottermeier, William Franklin, Swick, Aaron Michael
• Granted Patent: US 9,743,873 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0644 rotary valves
• 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
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A sample collection device for a fluid includes: a substantially disk-shaped body having a periphery; a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; and an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position.

Claims

1. A sample collection device for a fluid sample, the device comprising:

a substantially disk-shaped body having a periphery;

a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action;

a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; and

an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body.

2. A sample collection device as claimed in claim 1, wherein the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position.

3. A sample collection device as claimed in claim 2, wherein the air vent is located in the vicinity of and in fluid communication with the second end of the capillary channel when the disk is rotated in a first position.

4. A sample collection device as claimed in claim 1, wherein the opening of the first end is located on the side surface of the disk and the well is located on the top surface of the disk.

5. A sample collection device as claimed in claim 1, wherein the capillary channel is non-linear.

6. A sample collection device as claimed in claim 5, wherein the capillary channel has a semi-circular shape.

7. A sample collection device as claimed in claim 6, wherein the capillary channel has a staff shape.

8. A sample collection device as claimed in claim 1, wherein the first end is hydrophilic.

9. A sample collection device as claimed in claim 8, wherein the first end is provided with a hydrophilic coating.

10. A working element comprising:

a sample collection device for a fluid sample, the device comprising;

a substantially disk-shaped body having a periphery;

a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; and

an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body; and

a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position, and containing a sample manipulation device, wherein the sample collection device is rotatably positioned within the cartridge housing and at least a portion of the side and top surface of the disk are exposed for application of sample.

11. A working element as claimed in claim 10, wherein the air vent is located in the vicinity of and in fluid communication with the second end of the capillary channel when the disk is rotated in a first position.

12. A working element as claimed in claim 10, wherein the sample manipulation device includes a pre-manipulation portion.

13. A working element as claimed in claim 10, wherein the sample manipulation device is an analytical chamber having an analytical reagent thereon.

14. A working element as claimed in claim 13, wherein the analytical chamber is a lateral flow assay device.

15. A working element as claimed in claim 10, wherein the sample collection device is located at a first end of the cartridge housing and the portion of the side and top surface exposed are exposed at the first end of the cartridge.

16. A working element as claimed in claim 15, wherein sample collection device protrudes from the first end of the cartridge housing.

17. A working element as claimed in claim 15, wherein the sample collection device is fully contained within the cartridge housing and a portion of the cartridge housing is recessed from the first end to form a notch exposing the side and top surface of the disk.

18. A working element as claimed in claim 15, wherein when the sample collection device is rotated at a second position, the first end of the capillary channel is exposed at the first end of the cartridge.

19. A working element as claimed in claim 15, wherein when the sample collection device is rotated at a third position, the second end of the capillary channel is exposed at the first end of the cartridge.

20. A working element as claimed in claim 10, wherein when the disk is rotated in the first position, the first end is in communication with the sample manipulation device.

21. A working element as claimed in claim 20, wherein the air vent is adapted to be connected to a source of air pressure to force sample from the capillary channel through the first end and into the sample manipulation device.

22. A method for collecting a sample comprising:

providing a working element comprising;

a sample collection device for a fluid sample, the device comprising;

a substantially disk-shaped body having a periphery;

a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action;

a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; and

an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body; and

a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position, and containing a sample manipulation device, wherein the sample collection device is rotatably positioned within the cartridge and at least a portion of the side and top surface of the disk are exposed for application of sample;

rotating the sample collection device to a second position to position the first end into contact with a sample, or rotating the sample collection device into a third position to position the sample collection well into contact with a sample;

collecting the sample into the sample collection device;

rotating the sample collection device to the first position to position the first end into position with the sample manipulation device; and

applying air pressure to the air vent to force the sample across the barrier and into contact with the sample manipulation device.

23. A method as claimed in claim 22, wherein the air vent is located in the vicinity of and in fluid communication with the second end of the capillary channel when the disk is rotated in a first position.

24. A method as claimed in claim 22, wherein the sample manipulation device includes a pre-manipulation portion.

25. A method as claimed in claim 22, wherein the step of rotating the sample collection device to position the first or second end into contact with a sample further comprises rotating the sample collection device to the second position such that the first end extends away from the cartridge;

and bringing the first end into contact with the sample, whereby capillary action draws the sample into the channel and to the barrier.

26. A method as claimed in claim 25, wherein the step of bringing the first end into contact with the sample comprises bringing the first end into contact with a drop of blood on an animal.

27. A method as claimed in claim 25, wherein the rotation from the second position to the first position is approximately 180 degrees.

28. A method as claimed in claim 22, wherein the step of rotating the sample collection device to position the first or second end into contact with a sample further comprises rotating the sample collection device to the third position.

29. A method as claimed in claim 28, wherein the step of bringing the second end into contact with the sample comprises bringing the second end into contact with a syringe containing blood from an animal.

30. A method as claimed in claim 29, wherein the rotation from the third position to the first position is approximately 90 degrees.

31. A method as claimed in claim 22, wherein the sample is an aqueous fluid sample.

32. A method as claimed in claim 31, wherein the sample is whole blood, serum, plasma or urine.

33. A method as claimed in claim 29, wherein the animal is a mammal.

34. A method as claimed in claim 26, wherein the animal is a mammal.

35. A method as claimed in claim 33, wherein the mammal is a human.

36. A method as claimed in claim 34, wherein the mammal is a human.

37. A method of performing an assay on a liquid sample for the presence or concentration of one or more analyte(s) or control(s), on the assay device according to claim 22, comprising:

rotating the sample collection device to a second position to position the first end into contact with the sample, or rotating the sample collection device into a third position to position the sample collection well into contact with the sample;

collecting the sample into the sample collection device;

rotating the sample collection device to the first position to position the first end into position with the assay device; and

applying air pressure to the air vent to force the sample into contact with a sample addition zone of the assay device;

moving the sample by capillary action through a fluid flow path into a reagent zone where it dissolves one or more reagents;

flowing the sample away from the reagent zone having a dissolved reagent plume containing one or more reagents and into detection zone(s) by capillary action through the fluid flow path, wherein signal(s) representative of the presence or concentration of analyte(s) or control(s) is produced; and

reading the signal(s) that are produced in the detection zones to determine the presence or concentration of the analytes or controls.