ANALYTE-TESTING INSTRUMENTS

• US 20100041156A1
• Filed: 03/12/2007
• Published: 02/18/2010
• 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: Wu, Huan-Ping, Brenneman, Allen J.
• Granted Patent: US 8,906,305 B2
• Time in Patent Office: Days
• US Class Current: 436/48
• 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 adapted to determine an analyte concentration of a fluid sample using a test sensor is disclosed. The instrument comprises a display adapted to display information to a user, a user-interface mechanism adapted to allow the user to interact with the instrument, a first test-sensor cartridge, and a body portion including at least a first opening and a second opening formed therein. The first opening is adapted to receive a test sensor from the first test-sensor cartridge. The second opening is adapted to store at least one additional test-sensor cartridge.

Claims

1. An instrument adapted to determine an analyte concentration of a fluid sample using a test sensor, the instrument comprising:

a display adapted to display information to a user;

a user-interface mechanism adapted to allow the user to interact with the instrument;

a first test-sensor cartridge; and

a body portion including at least a first opening and a second opening formed therein, the first opening being adapted to receive a test sensor from the first test-sensor cartridge, the second opening being adapted to store at least one additional test-sensor cartridge.

2. The instrument of claim 1, wherein the body portion further includes a protective cover, the protective cover being adapted to be removed such that the additional test-sensor cartridge may be accessed.

3. The instrument of claim 1, wherein the at least one additional test-sensor cartridge is a plurality of additional test-sensor cartridges.

4. The instrument of claim 3, wherein the plurality of additional test-sensor cartridges is stacked.

5. A mechanism adapted to index and excise a test sensor from a test-sensor cartridge comprising:

an 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 adapted to be rotated 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 adapted to assist in rotating the test-sensor cartridge, the indexer face forming a second aperture therein, the second aperture adapted to be generally aligned with the test sensor; and

an excise mechanism comprising a push rod adapted to extend through the second aperture and a bar coupled with and generally parallel to the push rod.

6. The mechanism of claim 5, wherein the cartridge is adapted to be rotated and indexed when the indexer is rotated in a first direction, and

wherein the cartridge is adapted to remain substantially stationary when the indexer is rotated in a second direction generally opposite to the first direction.

7. The mechanism of claim 5, wherein the indexer is rotated by moving the tab.

8. An analyte-testing instrument adapted to determine the concentration of at least one analyte in a fluid, the analyte-testing instrument comprising:

a display adapted to display information to a user;

a user-interface mechanism adapted to allow the user to interact with the instrument;

a body portion including at least one opening formed therein, the at least one opening being adapted to receive a test sensor;

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 adapted to be rotated 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 adapted to assist in rotating the test-sensor cartridge, the indexer face forming a second aperture therein, the second aperture adapted to be generally aligned with the test sensor; and

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

9. The mechanism of claim 8, wherein the instrument further comprises a test-sensor cartridge comprising 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 opposite the cartridge face, the number of notches corresponding to the number of cavities, wherein the flexible pawl is adapted to fit between any two adjacent notches.

10. The assembly of claim 9, wherein the analyte-testing instrument further comprises an aperture in the body portion, the tab being adapted to extend therethrough,

wherein the length of the aperture in the body portion is sized such that the moving the 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.

11. The assembly of claim 10, wherein the analyte-testing instrument further comprises a second aperture in the body portion, at least a portion of the bar being adapted to extend therethrough such that the bar may be moved in a lateral direction to excise the test sensor.

12. A method of indexing and excising a test sensor from a test-sensor cartridge, the method comprising the acts of:

providing a test-sensor cartridge comprising 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 the second opposing face, the number of notches corresponding to the number of cavities;

providing an indexer comprising an indexer face, a retention pin extending through a first aperture formed generally through the center of the indexer face, a second aperture formed on the indexer face, a flexible pawl positioned near an edge of the indexer face, the flexible pawl being adapted to assist in rotating the test-sensor cartridge, and a user-accessible tab;

providing an excise mechanism comprising a push rod adapted to extend through the second aperture and a bar coupled with and generally parallel to the push rod;

rotating the indexer in a first direction about the retention pin such that the flexible pawl is positioned between a first notch and an adjacent second notch, wherein the notches are set off at an angle such that rotating the indexer in a first direction, but not in a second generally opposite direction, likewise rotates the cartridge;

rotating the indexer in the second direction such that the flexible pawl is positioned between the second notch and an adjacent third notch and the second aperture is generally aligned with a first test-sensor cavity;

moving the excise mechanism in a lateral direction such that the push rod extends through the second aperture and through a first end of the first test-sensor cavity; and

continuing to move the excise mechanism in the lateral direction until the first test sensor is excised through the second end of the first test-sensor cavity into a read position.

13. The method of claim 12, further comprising the act of performing an analyte-testing procedure.

14. The method of claim 13, further comprising the act of continuing to move the excise mechanism in the lateral direction such that the test-sensor is ejected.

15. The method of claim 12, further comprising the acts of providing an analyte-testing instrument comprising a display adapted to display information to a user, a user-interface mechanism adapted to allow the user to interact with the instrument, and a body portion including at least one opening formed therein, the at least one opening being adapted to receive the test sensor.

16. The method of claim 15, wherein the test sensor is aligned with electrical contacts within the analyte-testing instrument when the test sensor is in the read position.