US5872713A
Expired / Lapsed
US
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Synchronized analyte testing system
Assignee: Roche Diabetes Care Inc
•
Filing: 1997-10-30
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Granted: 1999-02-16
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Expires: 2017-10-30
Abstract
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.
Inventors
- 👤 Joel S. Douglas
- 👤 Karen R. Drexler
- 👤 Jeffrey N. Roe
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 00:01
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/528; A; A61; A61B; A61B5/00; A61B5/145; A61B5/14532; A61B5/1455; A61B5/1495; A61B5/15; A61B5/150007; A61B5/150015; A61B5/150022; A61B5/150206; A61B5/150259; A61B5/150305; A61B5/150343; A61B5/150358; A61B5/150374; A61B5/150381; A61B5/150412; A61B5/151; A61B5/15186; A61B5/157; A61B5/41; A61B5/414; A61B5/415; C; C12; C12Q; C12Q1/00; C12Q1/54; G01D; G01D3/00; G01D3/02; G01D3/022; G01N21/00; G01N21/84; G01N21/8483; G01N33/483; G01N33/487; G01N33/4875; G01N33/48757; G01N33/48771; G01N33/525; G01N33/66; A61B2560/00; A61B2560/04; A61B2560/0431; A61B2562/00; A61B2562/02; A61B2562/0295; A61B2562/08; A61B2562/085; A61B5/150503; G01N35/00; G01N35/00029; G01N2035/00099; G01N2035/00138; Y; Y10; Y10S; Y10S435/00; Y10S435/808; Y10S435/817
Claims Analysis
Total Claims: 40
Claim 1
Independent Claim
189 words
A synchronized detection device for detecting the presence of an analyte in a sample based on a physically detectable reaction of the sample with a reagent the device comprising: a set of test strips each containing the reagent disposed thereon, each set containing at least one test strip; calibration means corresponding to the set of test strips and containing calibration information uniquely characteristic to the reagent in the set of test strips; a housing having a docking portion for engaging at least one of the test strips; a sensor disposed at least partially in the housing an adapted to generate an electrical signal responsive to the reaction of the sample with the reagent; a processor disposed at least partially in the housing an adapted to operate in accordance with the calibration means to generate a detection signal representative of the presence of the analyte in the sample; the detection device is adapted for use a predetermined number of times, the processor tabulating the predetermined number of times using information contained in the calibration means; and the processor disabling use of the detection device after the predetermined number of times.
Claim 2
Dependent Claim
189 words
A synchronized detection device for detecting the presence of an analyte in a sample based on a physically detectable reaction of the sample with a reagent the device comprising: a set of test strips each containing the reagent disposed thereon, each set containing at least one test strip; calibration means corresponding to the set of test strips and containing calibration information uniquely characteristic to the reagent in the set of test strips; a housing having a docking portion for engaging at least one of the test strips; a sensor disposed at least partially in the housing an adapted to generate an electrical signal responsive to the reaction of the sample with the reagent; a processor disposed at least partially in the housing an adapted to operate in accordance with the calibration means to generate a detection signal representative of the presence of the analyte in the sample; the detection device is adapted for use a predetermined number of times, the processor tabulating the predetermined number of times using information contained in the calibration means; and the processor disabling use of the detection device after the predetermined number of times.
Claim 3
Dependent Claim
28 words
The device of claim 1, wherein the detection device is adapted for use a predtermined number of times corresponding to the number of test strips in the set.
Claim 4
Dependent Claim
21 words
The device of claim 1, wherein the processor is adapted to disable use of the detection device after a predetermined date.
Claim 5
Dependent Claim
24 words
The device of claim 1, wherein the calibration means comprises a chip containing correlation information for correlating the electrical signal to the detection signal.
Claim 6
Dependent Claim
36 words
The device of claim 4, wherein the detection device is adapted for use a plurality of said chips, each chip corresponding to an associated set of test strips and adapted to detachably connect to the housing.
Claim 7
Dependent Claim
16 words
The device of claim 4, wherein the correlation information is based on a predetermined mathematical function.
Claim 8
Dependent Claim
15 words
The device of claim 4, wherein the correlation information is based on a lookup table.
Claim 9
Dependent Claim
51 words
The device of claim 5, wherein each chip is adapted for use a predetermined number of times corresponding to the number of test strips in an associated set, the predetermined number of times being tabulated by the processor, the processor disabling use of the chip after the predetermined number of times.
Claim 10
Dependent Claim
28 words
The device claim 5, wherein each chip is adapted for use up to a predetermined date, the processor disabling the use of the chip after the predetermined date.
Claim 11
Dependent Claim
21 words
The device of claim 1, wherein the calibration means devices correlation information from a master test strip contained in the set.
Claim 12
Dependent Claim
25 words
The device of claim 1, wherein the docking portion is adapted to positively locate the test strip in a predtermined orientation relative to the sensor.
Claim 13
Dependent Claim
33 words
The device of claim 11, wherein the docking portion is adapted to matingly engage the test strip using engagment pins and corresponding holes such that only a successful mating achieves the predetermined orientation.
Claim 14
Dependent Claim
16 words
The device of claim 1, wherein the sensor comprises at least one LED and associated photodetector.
Claim 15
Dependent Claim
32 words
The device of claim 13, wherein the sensor comprises a first LED adapted to operate below a threshold radiation intensity and a second LED adapted to operate above the threshold radiation intensity.
Claim 16
Dependent Claim
36 words
The device of claim 13, wherein the sensor comprises a first LED adapted to detect total reflectance from the reaction and a second LED adapted to measure reflectance of a predetermined color component of the reaction.
Claim 17
Dependent Claim
21 words
The device of claim 13, wherein the sensor is provided with at least one molded lens optic system for focusing light.
Claim 18
Dependent Claim
14 words
The device of claim 1, further comprising a memory for storing the detection signal.
Claim 19
Dependent Claim
25 words
The device of claim 17, further comprising a modem for downloading the detection signal from the memory to a location remote from the detection device.
Claim 20
Dependent Claim
35 words
The device of claim 18, wherein the modem is disposed in a communication module which detachably engages the detection device for communication therewith, and which communicates with a storage device located at the remote location.
Claim 21
Dependent Claim
27 words
The device of claim 1, wherein the detection device is activated by an electromechanical switch triggered by the presence of a test strip in the docking portion.
Claim 22
Dependent Claim
27 words
The device of claim 1, wherein the detection device is activated by an optical switch triggered by the presence of a test strip in the docking portion.
Claim 23
Dependent Claim
32 words
The device of claim 1, wherein the detection device is activated by a pair of electrodes which sense the presence of the sample on a test strip disposed in the docking portion.
Claim 24
Dependent Claim
18 words
The device of claim 1, wherein the sensor comprises a pair of electrodes in electrical communication with sample.
Claim 25
Dependent Claim
13 words
The device of claim 13, wherein the photodetector is shielded from ambient radiation.
Claim 26
Dependent Claim
26 words
The device of claim 1, wherein a set of samplers is provided with the detection device, the number of samplers corresponding to the number test strips.
Claim 27
Dependent Claim
18 words
The device of claim 1, wherein the detection signal is displayed on a displayed disposed on the housing.
Claim 28
Dependent Claim
13 words
The device of the claim 26, wherein the display is an LCD device.
Claim 29
Dependent Claim
22 words
The device of claim 4, further comprising a memory, the correlation information being uploaded from the chip and stored in the memory.
Claim 30
Dependent Claim
12 words
The device of claim 28, wherein the chip is disabled following uploading.
Claim 31
Dependent Claim
13 words
The device of claim 28, further comprising a mechanical latch preventing multiple uploadings.
Claim 32
Dependent Claim
47 words
The device of claim 4, wherein the chip is provided with a counter, the correlation information being read by the processor a predetermined number of times corresponding to the number of test strips in an associated set of test strips, the counter being decremented with each reading.
Claim 33
Dependent Claim
18 words
The device of claim 1, wherein the processor prevents use of the calibration means following a predetermined duration.
Claim 34
Dependent Claim
15 words
The device of claim 1, wherein a sampling device is provided with the detection device.
Claim 35
Dependent Claim
15 words
The device of claim 25, wherein a sampling device is provided with the detection device.
Claim 36
Dependent Claim
37 words
The device of claim 4, wherein the chip is read once and disabled, the calibration information being stored for a specific number of tests corresponding to the number of test strips in associated set of test strips.
Claim 37
Dependent Claim
11 words
The device of claim 4, wherein the chip comprises an EEPROM.
Claim 38
Dependent Claim
17 words
The device of claim 4, wherein the chip comprises a microprocessor adapted to permit intelligent data transfer.
Claim 39
Dependent Claim
11 words
The device of claim 4, wherein the chip comprises an EPROM.
Claim 40
Dependent Claim
19 words
The device of claim 1, wherein the calibration means comprises a ROM contained within the housing of the device.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-02-15 | 2002-08-17 | 2003-02-16 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-02-15 | 2006-08-17 | 2007-02-16 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-02-15 | 2010-08-17 | 2011-02-16 | $7700.00 | Window Closed / Lapsed |