Personal portable blood glucose meter with replaceable cartridge of test strips

• US 7,638,095 B2
• Filed: 02/10/2006
• Issued: 12/29/2009
• Est. Priority Date: 02/10/2006
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Sabol, Peter
• Primary Examiner(s): Hill, Jr.; Robert J
• Assistant Examiner(s): Gerido; Dwan A
• Application Number:
  US11/276,043
• Publication Number:
  US 20070189928A1
• Time in Patent Office: 1,418 Days
• Field of Search: 422/68.1, 422/56, 422/58, 422/61, 422/63, 422/65, 422/99, 422/82.05, 422/102, 436/43, 436/46, 436/180, 204/406, 204/407
• US Class Current: 422/68.1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool

Abstract

A test meter system includes a cartridge that houses a test strip tape, which includes a plurality of test elements, and the cartridge defines a meter opening. The cartridge further incorporates an indexing mechanism for indexing the test strip tape. A meter is configured to analyze body fluid via the test strip tape, and the meter includes a display for displaying test results as well as other information. At least a portion of the meter is received in the meter opening of the cartridge to provide a compact configuration. In one form, the test strip system has a generally cylindrical outer shape to provide a pleasing handheld shape.

Claims

1. A portable meter system, comprising:

a cartridge housing a test strip tape that includes a plurality of test elements, the cartridge defining a meter opening;

a meter configured to analyze a body fluid via the test strip tape, at least a portion of the meter being received in the meter opening of the cartridge, wherein the portion of the meter includes a projection received in the meter opening, wherein a stop flange extends from one end of the projection;

wherein the portion of the meter received in the meter opening of the cartridge includes a display that is visible;

wherein the cartridge encircles the display;

the cartridge having a sampling portion where the test elements are configured to receive the body fluid;

the test elements including electrochemical test strips with one or more contacts;

the meter including one or more contacts coupled to the portion of the meter received inside the meter opening;

the contacts of the meter being configured to contact the contacts of the electrochemical test strips when at the sampling portion of the cartridge;

the meter including an alignment key member to which the contacts of the meter are coupled, wherein the alignment key member extends from the projection; and

the cartridge including an alignment key opening in which the alignment key member is received for aligning the contacts of the meter with the contacts of the electrochemical test strips when positioned within the sampling portion.

2. The system of claim 1, wherein the cartridge includes an indexing mechanism configured to index the test strip tape.

3. The system of claim 2, wherein the test strip tape has at least one indexing notch, the indexing mechanism being configured to engage the test strip tape at the indexing notch.

4. The system of claim 3, wherein:

the test strip tape has break lines between the test elements for breaking off individual test elements from the test strip tape; and

the indexing notch is disposed between the test elements adjacent the break lines.

5. The system of claim 3, wherein:

the indexing member includes a grip member configured to engage indexing notch;

the cartridge defines a groove for guiding the grip member during indexing; and

the cam groove is configured to guide the grip member in a direction that is transverse to the test strip tape for engaging the grip member with the indexing notch.

6. The system of claim 3, wherein:

the indexing member includes a grip member configured to engage indexing notch; and

the cartridge has a cam member configured to deflect the grip member into engagement with the indexing notch.

7. The system of claim 2, wherein the indexing mechanism includes a pusher member configured to frictionally engage the test strip tape to index the test strip tape.

8. The system of claim 1, wherein the electrochemical test strips each include:

a first substrate;

a second substrate;

a reagent disposed between the first substrate and the second substrate;

electrodes contacting the reagent between the first substrate and the second substrate; and

wherein the first substrate defines one or more contact openings along the electrodes that define the contacts of the electrochemical test strips.

9. The system of claim 8, wherein:

the electrochemical test strips each include a cover layer; and

the second substrate defines a sample chamber for receiving the body fluid.

10. The system of claim 8, wherein the reagent includes a mesh for rawing the body fluid via capillary action.

11. The system of claim 1, wherein the display is disposed on at least a portion of the projection.

12. The system of claim 11, wherein:

the meter opening in the cartridge opens on opposite sides of the cartridge;

the projection of the meter extends completely through the cartridge; and

the display is disposed on the end of the projection that is opposite the flange.

13. The system of claim 1, wherein the cartridge includes:

a sampling portion where the test elements are configured to receive the body fluid; and

a relief indentation at the sampling portion that is concavely shaped to receive a body part.

14. The system of claim 13, wherein each test element includes a relief notch that is concavely shaped similarly to the sampling portion to receive the body part.

15. The system of claim 1, wherein the cartridge includes at least one identifier configured to provide information for calibrating the meter.

16. The system of claim 15, wherein the at least one identifier includes non-evident coding for calibrating the meter.

17. The system of claim 1, wherein the cartridge has a cylindrical outer shape.

18. The system of claim 1, wherein the cartridge includes a coupling flange configured to engage the stop flange of the meter.

19. The system of claim 1, wherein the meter is substantially disposed inside the meter opening of the cartridge.

20. The system of claim 1, wherein:

the cartridge includes means for housing the test strip tape; and

the meter includes electronic means for analyzing the body fluid using electrochemical or optical analysis.

21. The system of claim 1, wherein the cartridge includes:

an advancement slot;

an advancement button slidably disposed along the advancement slot for advancing the test strip tape; and

one or more seals disposed along the advancement slot, the seals being configured to seal against the advancement button.

22. The system of claim 1, wherein the cartridge includes one or more seals sealing against the test strip tape to prevent contaminants from entering the cartridge.

23. A portable meter system, comprising:

a cartridge housing a test strip tape that includes a plurality of test elements, the cartridge defining a meter opening;

a meter configured to analyze a body fluid via the test strip tape, at least a portion of the meter being received in the meter opening of the cartridge;

wherein the portion of the meter received in the meter opening of the cartridge includes a display that is visible;

wherein the cartridge encircles the display;

wherein the cartridge includes an indexing mechanism configured to index the test strip tape;

wherein the test strip tape has at least one indexing notch, the indexing mechanism being configured to engage the test strip tape at the indexing notch;

wherein the indexing member includes a grip member configured to engage indexing notch;

wherein the cartridge defines a groove for guiding the grip member during indexing; and

wherein a cam groove is configured to guide the grip member in a direction that is transverse to the test strip tape for engaging the grip member with the indexing notch.

24. The system of claim 23, wherein the portion of the meter includes a projection received in the meter opening and a stop flange extending from one end of the projection.

25. The system of claim 24, wherein the cartridge includes a coupling flange configured to engage the stop flange of the meter.

26. The system of claim 23, wherein:

the meter opening in the cartridge opens on opposite sides of the cartridge;

the projection of the meter extends completely through the cartridge; and

the display is disposed on the end of the projection that is opposite the flange.

27. The system of claim 23, wherein:

the test strip tape has break lines between the test elements for breaking off individual test elements from the test strip tape; and

the indexing notch is disposed between the test elements adjacent the break lines.

28. A portable meter system, comprising:

a cartridge housing a test strip tape that includes a plurality of test elements, the test elements including electrochemical test strips with one or more contacts, the cartridge having a sampling portion where the test elements are exposed to receive body fluid, the cartridge having an overall ring shape that defines a meter opening with a cylindrical shape, the cartridge having an alignment notch at the meter opening that is aligned with the sampling portion; and

a meter configured to analyze a body fluid via the test strip tape, the meter including

a projection extending through the meter opening in the cartridge,

a stop flange extending from one end of the projection, the stop flange abutting one side of the cartridge to locate the projection inside the meter opening of the cartridge,

the projection having at the end opposite the stop flange a display to display test results, the cartridge housing encircling the display to reduce damage to the display, and

an alignment key member extending from the projection, the alignment key member including one or more contacts, the alignment key member being received in an alignment notch to connect the contacts of the test elements with the contacts of the key member when the test elements are at the sampling portion of the cartridge.

29. The system of claim 28, wherein the cartridge includes an indexing mechanism configured to index the test strip tape.

30. The system of claim 29, wherein the test strip tape has at least one indexing notch, the indexing mechanism being configured to engage the test strip tape at the indexing notch.

31. The system of claim 29, wherein the indexing mechanism includes a pusher member configured to frictionally engage the test strip tape to index the test strip tape.