Mechanical device for mixing a fluid sample with a treatment solution

• US 7,749,770 B2
• Filed: 08/10/2009
• Issued: 07/06/2010
• 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:
  US12/462,810
• Publication Number:
  US 20100041164A1
• Time in Patent Office: 330 Days
• Field of Search: 436/179, 422/63
• US Class Current: 436/179
• 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 method of preparing a fluid sample for use in a fluid analyte monitor, the method including 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; 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. The method may also include shaking the treatment solution chamber with the capillary channel therein, thereby mixing the fluid sample with the contents of the treatment solution chamber.

Claims

1. 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 chamber such that the mixed fluid and treatment solution chamber contents are received into a fluid analyte meter.

2. The method of claim 1, wherein the fluid sample is blood.

3. The method of claim 1, wherein the fluid sample is interstitial fluid.

4. The method of claim 1, 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.

5. The method 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.

6. The method 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.

7. 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, the first portion having a component adapted to penetrate a septum;

moving a second portion of the device comprising a treatment solution chamber with respect to the first portion of the device to penetrate a septum of the 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 first portion of the device and into a fluid analyte meter.

8. The method of claim 7, 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.

9. The method of claim 7, 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.

10. The method of claim 7, wherein the fluid sample is blood.

11. The method of claim 7, wherein the fluid sample is interstitial fluid.

12. The method of claim 7, wherein the fluid sample contains prostate specific antigen.

13. 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;

mixing the fluid sample with the contents of the treatment solution chamber; and

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

14. The method of claim 13, wherein the fluid sample is blood.

15. The method of claim 13, wherein the fluid sample is interstitial fluid.

16. The method of claim 13, 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.

17. The method of claim 13 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.

18. The method of claim 13 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.

19. The method of claim 14, wherein said mixing is achieved by shaking the treatment solution chamber with the capillary channel therein.

20. The method of claim 15, wherein said mixing is achieved by shaking the treatment solution chamber with the capillary channel therein.