Analyte-testing instruments

• US 9,170,251 B2
• Filed: 11/03/2014
• Issued: 10/27/2015
• Est. Priority Date: 03/12/2007
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Brenneman, Allen J., Wu, Huan-Ping
• Primary Examiner(s): Gakh, Yelena G
• Assistant Examiner(s): Adams, Michelle
• Application Number:
  US14/531,583
• Publication Number:
  US 20150052982A1
• Time in Patent Office: 358 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: B65D 83/0454 the whole forming a circular container with rotating parts B65D83/0463 takes precedence
• CPC Class Codes: B65D 83/0829 by means of an actuator
• CPC Class Codes: G01N 2035/00089 Magazines
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• 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
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 436/114165 with step of insertion or removal from test line
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

An instrument configured to determine the concentration of at least one analyte in a fluid is disclosed. The instrument comprises a display, a user-interface mechanism, and a body portion. The body portion houses a test-sensor cartridge and includes an opening configured to receive a test sensor from the test-sensor cartridge. The body portion further includes an indexer and an excise mechanism positioned within the body portion. The indexer includes an indexer face, a retention pin, a flexible pawl, and a user-accessible tab. The indexer is configured to rotate about the retention pin, which extends through a first aperture in the indexer face. The excise mechanism includes a push rod configured to extend through a second aperture in the indexer face and a bar coupled with and generally parallel to the push rod.

Claims

1. An instrument configured to determine the concentration of at least one analyte in a fluid, the instrument comprising:

a display configured to display information;

a user-interface mechanism configured to allow interaction with the instrument;

a body portion including a test-sensor cartridge housed therein and an opening configured to receive a test sensor from the test-sensor cartridge;

an indexer positioned within the body portion, the indexer comprising an indexer face, a retention pin, a flexible pawl, and a user-accessible tab, the retention pin extending through a first aperture formed generally through the center of the indexer face, the indexer being configured to rotate in a first direction and a second direction about the retention pin, the flexible pawl positioned near an edge of the indexer face, the flexible pawl being configured to assist in rotating the test-sensor cartridge, the indexer face having a second aperture formed therein, the second aperture configured to be generally aligned with the test sensor; and

an excise mechanism positioned within the body portion, the excise mechanism comprising a push rod configured to extend through the second aperture and a bar coupled with and generally parallel to the push rod.

2. The instrument of claim 1, wherein the test-sensor cartridge includes a first face, a second opposing face, and a side portion connecting the first and second opposing faces, the first face forming a plurality of test-sensor cavities that is generally uniformly positioned therethrough, and a plurality of generally uniformly spaced notches positioned on an end of the cartridge adjacent the second face, the number of notches corresponding to the number of cavities.

3. The instrument of claim 2, wherein the instrument further comprises an aperture in the body portion, the user-accessible tab being configured to extend therethrough,

wherein the length of the aperture in the body portion is sized such that moving the user-accessible tab from a first end of the aperture to a second end of the aperture rotates the indexer approximately 360/n degrees, where n is the number of test-sensor cavities in the test-sensor cartridge.

4. The instrument of claim 3, wherein the body portion is configured to receive at least a portion of the bar such that the bar may be moved within the body portion in a lateral direction to excise the test sensor.

5. The instrument of claim 2, wherein the flexible pawl is configured to bend when the indexer is rotated about the retention pin and to spring back into a position between the two adjacent notches.

6. The instrument of claim 1, wherein the test-sensor cartridge is configured to be rotated and indexed when the indexer is rotated in the first direction and the test-sensor cartridge is configured to remain substantially stationary when the indexer is rotated in the second direction generally opposite to the first direction.

7. The instrument of claim 1, wherein the indexer is rotated by moving the user-accessible tab.

8. The instrument of claim 1, wherein the test-sensor cartridge is housed within a first compartment of the body portion, wherein the body portion further includes a second compartment configured to store at least one additional test-sensor cartridge.

9. The instrument of claim 8, further comprising a protective cover, the protective cover being removable such that the at least one additional test-sensor cartridge may be accessed.

10. The instrument of claim 8, wherein the at least one additional test-sensor cartridge is a plurality of additional test-sensor cartridges.

11. The instrument of claim 10, wherein the plurality of additional test-sensor cartridges is stacked within the second compartment of the body portion.

12. The instrument of claim 1, wherein the instrument has a generally elongated shape.

13. An instrument configured to determine the concentration of at least one analyte in a fluid, the instrument comprising:

a body portion including;

a display;

a user-interface mechanism;

a test-sensor cartridge housed within the body portion, the test-sensor cartridge including;

a plurality of test-sensor cavities formed therein, each of the plurality of test-sensor cavities including a test sensor housed therein; and

a plurality of generally uniformly-spaced notches positioned along an edge of a first end of the test-sensor cartridge, each of the plurality of notches corresponding with a respective one of the plurality of test-sensor cavities;

a dispensing port for receiving a test sensor from the test-sensor cartridge;

an indexer including;

an indexer face having an aperture formed therein, the indexer being positioned within the body portion such that the indexer face is generally adjacent to the first end of the test-sensor cartridge and the aperture is generally aligned with one of the test sensors of the test-sensor cartridge;

a flexible pawl configured to engage with a first notch of the test-sensor cartridge when the test-sensor cartridge is rotated in a first direction and configured to disengage from the first notch when the test-sensor cartridge is rotated in a second direction; and

a user-accessible tab extending through an opening in the body portion such that the user-accessible tab may be used to rotate the indexer in the first and second directions; and

an excise mechanism positioned within the body portion, the excise mechanism comprising a push rod configured to extend through the aperture of the indexer face to assist in positioning the test sensor generally aligned with the aperture into the dispensing port.

14. The instrument of claim 13, wherein the length of the opening in the body portion is sized such that moving the user-accessible tab from a first end of the opening to a second end of the opening rotates the indexer approximately 360/n degrees, where n is the number of test-sensor cavities in the test-sensor cartridge.

15. The instrument of claim 13, wherein the excise mechanism further includes a ridged portion extending through a second opening in the body portion such that the ridged portion of the excise mechanism extending from the body portion may be used to assist in moving the excise mechanism to excise one of the test sensors from the test-sensor cartridge.

16. The instrument of claim 13, wherein the indexer further includes a retention pin extending through a second aperture formed generally through the center of the indexer face, the indexer being configured to rotate in the first direction and the second direction about the retention pin.

17. The instrument of claim 13, wherein the test-sensor cartridge is housed within a first compartment of the body portion, wherein the body portion further includes a second compartment configured to store at least one additional test-sensor cartridge.

18. The instrument of claim 13, wherein the flexible pawl is configured to bend when the indexer is rotated and spring back into a position between two adjacent notches.