Mechanical device for mixing a fluid sample with a treatment solution

• US 20050196872A1
• Filed: 01/25/2005
• Published: 09/08/2005
• Est. Priority Date: 03/05/2004
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Nguyen, Hoa, Ramel, Urs A., Pierce, Jeffrey A.
• Granted Patent: US 7,588,724 B2
• Time in Patent Office: Days
• US Class Current: 436/174
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01F 25/433 Mixing tubes wherein the shape of the tube influences the mixing, e.g. mixing tubes with varying cross-section or provided with inwardly extending profiles
• CPC Class Codes: B01F 25/4338 Mixers with a succession of converging-diverging cross-sections, i.e. undulating cross-section
• CPC Class Codes: B01F 31/20 Mixing the contents of independent containers, e.g. test tubes
• CPC Class Codes: B01F 35/32021 Shaking by hand a portable receptacle or stirrer for mixing
• CPC Class Codes: B01F 35/713 comprising breaking packages or parts thereof, e.g. piercing or opening sealing elements between compartments or cartridges containers or packages per se B65D
• CPC Class Codes: B01F 35/7131 Breaking or perforating packages, containers or vials
• CPC Class Codes: B01F 35/7137 Piercing, perforating or melting membranes or closures which seal the compartments
• CPC Class Codes: G01N 1/38 Diluting, dispersing or mixing samples
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/25625 Dilution

Abstract

A device for preparing a fluid sample for use in a fluid analyte meter, including: (a) a first portion, comprising: a capillary channel dimensioned to receive a fluid sample therein, an internal nozzle in communication with the capillary channel, a mixing chamber in communication with both the capillary channel and the internal nozzle, and a dispensing nozzle in communication with the mixing chamber; (b) a treatment solution chamber covered by a septum; and (c) a second portion that is moveable with respect to the first portion to pierce the septum such that contents of the treatment solution chamber mix with contents of the capillary channel in the mixing chamber and are ejected through the dispensing nozzle when the second portion is moved with respect to the first portion.

Claims

1. A device for preparing a fluid sample for use in a fluid analyte meter, comprising:

a first portion, comprising;

a septum piercing projection, and

a capillary channel; and

a second portion, comprising;

a treatment solution chamber,

a first septum sealing the treatment solution chamber, and

a second septum sealing the treatment solution chamber.

2. The device of claim 1, wherein the first septum is positioned across the top of the treatment solution chamber and the second septum is positioned across the bottom of the treatment solution chamber.

3. The device of claim 1, wherein the septum piercing projection pierces through the first septum, such that the capillary channel is received into the treatment solution chamber when the first portion of the device is inserted into the second portion of the device.

4. The device of claim 1, wherein the capillary channel is disposed within the septum piercing projection.

5. The device of claim 1, further comprising:

a fluid analyte meter; and

a mechanism on the fluid analyte meter that causes the second septum to be pierced so as to release the contents of the treatment solution chamber into the fluid analyte meter.

6. The device of claim 5, wherein the fluid analyte meter measures hemoglobin A1c.

7. The device of claim 1, wherein the second portion is dimensioned such that the second septum is pierced so as to release the contents of the treatment solution chamber into a fluid analyte meter when the second portion of the device is received into a port in the fluid analyte meter.

8. A method of preparing a fluid sample for use in a fluid analyte monitor, comprising:

drawing a fluid sample into a capillary channel in a body having a septum piercing projection;

piercing a first septum covering a treatment solution chamber with the septum piercing projection, thereby exposing the fluid sample in the capillary channel to the contents of the treatment solution chamber;

shaking the treatment solution chamber with the capillary channel therein, thereby mixing the fluid sample with the contents of the treatment solution chamber; and

piercing a second septum covering the treatment solution channel such that the mixed fluid and treatment solution chamber contents are received into a fluid analyte meter.

9. The method of claim 8, wherein the fluid sample is blood.

10. The method of claim 8, wherein the fluid sample is interstitial fluid.

11. The method of claim 8, wherein the septum piercing projection and the capillary channel are disposed on a first portion of a device, and wherein the treatment solution chamber and the first septum covering the treatment solution chamber are disposed on a second portion of the device, and wherein the first and second portions of the device mate together.

12. A device for preparing a fluid sample for use in a fluid analyte meter, comprising:

a first portion, comprising;

a septum piercing projection, and

a capillary channel; and

a second portion, comprising;

a treatment solution chamber, and

a septum sealing the treatment solution chamber.

13. The device of claim 12, wherein the septum piercing projection pierces through the septum, such that the capillary channel is received into the treatment solution chamber when the first portion of the device is inserted into the second portion of the device.

14. A device for preparing a fluid sample for use in a fluid analyte meter, comprising:

a first portion having a capillary channel dimensioned to receive a fluid sample therein; and

a second portion having a treatment solution chamber enclosed by first and second septums, wherein the first portion penetrates the first septum when the first portion is inserted into the second portion such that contents of the treatment solution chamber mix with contents of the capillary channel; and

a mechanism for penetrating the second septum such that contents of the treatment solution chamber and the capillary channel can be ejected from the device.

15. The device of claim 14, wherein the mechanism for penetrating the second septum comprises:

a dispensing nozzle, wherein movement of the dispensing nozzle with respect to the first portion of the device penetrates the second septum such that the contents of the treatment solution chamber and the capillary channel are ejected through the dispensing nozzle.

16. The device of claim 15, wherein the dispensing nozzle is received into the second portion of the device.

17. The device of claim 15, further comprising:

a removable tab on the second portion of the device to permit movement of the dispensing nozzle with respect to the second portion of the device, such that the second septum can be penetrated.

18. The device of claim 14, further comprising:

a stop junction in communication with the capillary channel.

19. The device of claim 18, wherein the stop junction is a bore passing through the first portion of the device in communication with an end of the capillary channel.

20. The device of claim 14, wherein the first portion of the device is received into the second portion of the device.

21. The device of claim 14, further comprising:

a fluid analyte meter configured to measure hemoglobin A1c.

22. A device for preparing a fluid sample for use in a fluid analyte meter, comprising:

a first portion, comprising;

a capillary channel dimensioned to receive a fluid sample therein,

an internal nozzle in communication with the capillary channel,

a mixing chamber in communication with both the capillary channel and the internal nozzle, and

a dispensing nozzle in communication with the mixing chamber;

a treatment solution chamber covered by a septum; and

a second portion that is moveable with respect to the first portion to pierce the septum such that contents of the treatment solution chamber mix with contents of the capillary channel in the mixing chamber and are ejected through the dispensing nozzle when the second portion is moved with respect to the first portion.

23. The device of claim 22, wherein the treatment solution chamber is located in the first portion of the device.

24. The device of claim 22, wherein the treatment solution chamber is located in the second portion of the device.

25. The device of claim 22, wherein the first portion of the device is received into the second portion of the device.

26. The device of claim 22, wherein the second portion of the device is received into the first portion of the device.

27. The device of claim 22, wherein the mixing chamber is dimensioned to cause turbulent flow mixing therein of treatment solution received from the internal nozzle and a fluid sample received from the capillary channel.

28. The device of claim 22, wherein the internal nozzle and the capillary channel meet at a Y-junction adjacent to an inlet to the mixing chamber such that treatment solution passing through the internal nozzle draws a fluid sample in the capillary channel into the mixing chamber.

29. A device for preparing a fluid sample for use in a fluid analyte meter, comprising:

a first portion having a capillary channel dimensioned to receive a fluid sample therein;

a treatment solution chamber enclosed by septum; and

a second portion, wherein the first portion penetrates the septum when the first portion is inserted into the second portion such that contents of the treatment solution chamber mix with contents of the capillary channel, such that contents of the treatment solution chamber and the capillary channel can be ejected from the device.

30. The device of claim 29, further comprising:

a third portion of the device, wherein the treatment solution chamber is disposed in the third portion of the device.

31. The device of claim 30, wherein the third portion of the device includes side flues.

32. The device of claim 30, wherein the third portion of the device includes a bottom mixing groove.

33. A method of using a device to prepare a fluid sample for use in a fluid analyte meter, comprising:

drawing a fluid sample into a capillary channel in a first portion of the device;

moving a second portion of the device with respect to the first portion of the device to penetrate a septum of a treatment solution chamber such that contents of the treatment solution chamber are mixed with the fluid sample in the capillary channel; and

ejecting the mixed treatment solution and fluid sample through a dispensing nozzle of the device and into a fluid analyte meter.

34. The method of claim 33, further comprising:

mixing the contents of the treatment solution chamber with the fluid in the capillary channel by shaking the first portion of the device.

35. The method of claim 33, further comprising:

mixing the contents of the treatment solution chamber with the fluid in the capillary channel in a mixing chamber in the first portion of the device.

36. The method of claim 33, wherein the fluid sample is blood.

37. The method of claim 33, wherein the fluid sample is interstitial fluid.

38. The method of claim 33, wherein the fluid sample contains prostate specific antigen.