Synchronized analyte testing system

• US 7,347,973 B2
• Filed: 04/04/2003
• Issued: 03/25/2008
• Est. Priority Date: 10/30/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Douglas, Joel S., Drexler, Karen R., Roe, Jeffrey N.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/407,635
• Publication Number:
  US 20030219357A1
• Time in Patent Office: 1,817 Days
• Field of Search: 422/58, 422/61, 422/82.01, 422/82.02, 422/82.03
• US Class Current: 422/403
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01D 3/022 having an ideal characteristic, map or correction data stored in a digital memory
• CPC Class Codes: G01N 2035/00138 Slides
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/48757 : Test elements dispensed from a stack
• CPC Class Codes: G01N 33/48771 : Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/525 : Multi-layer analytical elements
• CPC Class Codes: G01N 33/528 : Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/66 : involving blood sugars, e.g. galactose
• CPC Class Codes: Y10S 435/808 : Optical sensing apparatus
• CPC Class Codes: Y10S 435/817 : Enzyme or microbe electrode

Abstract

An analyte detection system is provided with calibration information uniquely specific to the set of test strips to which the sample is to be applied. The calibration information may be stored in permanent memory of the testing device, such that the device is discarded after use of all the test strips in a kit, or it may be stored in a calibration chip accompanying the set of test strips and distributed therewith, thereby enabling re-use of the testing device with a different set of test strips and associated calibration chip.

Claims

1. A portable medical analyzer kit, comprising:

a sampler configured to puncture tissue;

a test strip comprising a test pad and at least one channel to transport the body fluid to the test pad, wherein the channel is configured to receive the body fluid from the tissue punctured with the sampler;

a testing instrument comprising a sensor positioned to read the test strip when the test strip is docked with the testing instrument, the testing instrument including a microprocessor and memory;

a modem adapted to communicate information from the testing instrument to a remote processing unit;

a calibration chip configured to provide lot specific calibration information about the test strip to the testing instrument, the calibration chip being detachably connectable to the testing instrument at a location that is separate from the test strip; and

wherein the calibration chip has a counter configured to limit the testing instrument to perform only a specific number of tests that correspond to the number of test strips supplied in the kit.

2. The portable medical analyzer kit of claim 1, wherein:

the sampler includes a lancet;

the test strip includes a cartridge;

the testing instrument includes an analytical detector module; and

the modem includes a communication module.

3. The portable medical analyzer kit of claim 1, wherein:

the remote processing unit includes an internet location.

4. The portable medical analyzer kit of claim 1, wherein:

the remote processing unit includes an electronic bulletin board.

5. The portable medical analyzer kit of claim 1, wherein:

the testing instrument includes a display to display measurement results.

6. The portable medical analyzer kit of claim 1, wherein:

the testing instrument includes memory to store measurement results.

7. A portable medical analyzer kit, comprising:

a lancet configured to cut an incision in tissue;

a test strip configured to analyze body fluid from the incision cut by the lancet;

a testing instrument configured to receive the test strip for analysis of the body fluid from the incision;

a communication module configured to communicate analysis results from the testing instrument to a remote processing unit; and

a calibration chip containing calibration information for the test strip, wherein the calibration chip includes a counter to limit the number of tests performed by the testing instrument, the calibration chip being detachably connectable to the testing instrument separate from the test strip.

8. The portable medical analyzer kit of claim 7, wherein:

the communication module includes a modem.

9. The portable medical analyzer kit of claim 7, wherein:

the test strip is an optical type test strip.

10. The portable medical analyzer kit of claim 7, further comprising:

a chip containing expiration information pertaining to the test strip; and

wherein the testing instrument is configured to limit testing based on the expiration information.