Mechanical device for mixing a fluid sample with a treatment solution

• US 7,588,724 B2
• Filed: 01/25/2005
• Issued: 09/15/2009
• 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.
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Kingan; Timothy G
• Application Number:
  US11/043,510
• Publication Number:
  US 20050196872A1
• Time in Patent Office: 1,694 Days
• Field of Search: None
• US Class Current: 422/547
• 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 sample treatment solution contained within the treatment solution chamber, the device further comprising 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 capillary channel is disposed within the septum piercing projection.

4. The device of claim 1 further comprising a third member comprising a second septum piercing member for penetrating the second septum such that contents of the treatment solution chamber and the capillary channel can be ejected from the device.

5. The device of claim 4, wherein the first septum piercing member comprises a dispensing nozzle.

6. The device of claim 5, wherein the dispensing nozzle is adapted to be received into the second portion of the device.

7. The device of claim 5, further comprising a removable tab on the second portion adapted to permit movement of the dispensing nozzle with respect to the second portion of the device, such that the second septum can be penetrated.

8. The device of claim 1, further comprising:

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

9. The device of claim 8, wherein the third portion includes side flues.

10. The device of claim 8, wherein the third portion includes a bottom mixing groove.

11. 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 sample treatment solution contained within the treatment solution chamber; and

first and second septa sealing the treatment solution chamber wherein the first and second portions of the device are adapted to 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,

a capillary channel; and

an aperture extending through the first portion into the capillary channel;

and a second portion, comprising;

a treatment solution chamber,

a sample treatment solution contained within the treatment solution chamber; and

a septum sealing the treatment solution chamber.

13. The device of claim 12, wherein the stop junction is a bore passing through the first portion of the device in communication with an end of the capillary channel.

14. 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 sample treatment solution contained within the treatment solution chamber; and

a pair of septa sealing the treatment solution chamber wherein the first portion of the device is adapted to be received into the second portion of the device.

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

a first portion, comprising;

a septum piercing projection,

a capillary channel,

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;

and a second portion, comprising;

a treatment solution chamber,

a sample treatment solution contained within the treatment solution chamber; and

a septum sealing the treatment solution chamber.

16. The device of claim 15, wherein the mixing chamber is dimensioned to cause turbulent flow mixing therein of a treatment solution received from the internal nozzle and a fluid sample received from the capillary channel.

17. The device of claim 15, 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.

18. A system for preparing a fluid sample for use in a fluid analyte meter, comprising:

a sample collection member comprising;

a septum piercing projection,

and a capillary channel; and

a sample treatment member, comprising;

a treatment solution chamber having a first septum and a second septum sealing the treatment solution chamber,

a sample treatment solution contained within the treatment solution chamber.

19. The system of claim 18, wherein the septum piercing projection is adapted to pierce the first septum, and wherein the system further comprises a dispensing nozzle adapted to penetrate the second septum.

20. A kit comprising the system of claim 18 and a fluid analyte meter.

21. The kit of claim 20, wherein the fluid analyte meter further comprises a member adapted to pierce the second septum.

22. The kit of claim 20, wherein the fluid analyte meter measures hemoglobin A1c.