Analyte Monitoring Device and Methods of Use

• US 20100094110A1
• Filed: 06/30/2009
• Published: 04/15/2010
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Adam, Wang, Yi, Galasso, John R., Karinka, Shridhara Alva, Feldman, Benjamin Jay
• Granted Patent: US 8,688,188 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• 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 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7246 : using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7278 : Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 : using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7445 : Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 : characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• 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 27/3273 : Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

In aspects of the present disclosure, a no coding blood glucose monitoring unit including a calibration unit is integrated with one or more components of an analyte monitoring system to provide compatibility with in vitro test strip that do not require a calibration code is provided. Also disclosed are methods, systems, devices and kits for providing the same.

Claims

1. An apparatus including an integrated monitor and display unit, comprising:

a housing, comprising;

an rf receiver disposed in the housing to receive data from a transmitter that is configured and arranged to transmit data relating to analyte signals from a transcutaneous analyte sensor;

an analyte sensor port coupled with the housing and configured to receive an in vitro analyte sensor, wherein the analyte sensor generates an analyte signal from a fluid sample;

a memory comprising at least one calibration parameter stored therein associated with the vitro analyte sensor; and

a processor disposed in the housing and operatively coupled to the rf receiver and the memory, the processor configured to validate the data relating to analyte signals from the transcutaneous analyte sensor based at least in part on the analyte signal from the in vitro analyte sensor.

2. The apparatus of claim 1, wherein the analyte sensor port is configured to contact an insertion monitor on a surface of the in vitro analyte sensor, and further, wherein the processor is configured to recognize a calibration parameter from the insertion monitor and to identify a corresponding stored calibration parameter stored in the memory.

3. The apparatus of claim 2, wherein the processor is configured to recognize the calibration parameter based on a shape of the insertion monitor.

4. The apparatus of claim 2, wherein the processor is configured to recognize the calibration parameter based on a position of the insertion monitor.

5. The apparatus of claim 2, wherein the processor is configured to recognize the calibration parameter based on an electrical characteristic of the insertion monitor.

6. The apparatus of claim 2, wherein the processor is configured to recognize the calibration parameter based on a resistance of the insertion monitor.

7. The apparatus of claim 2, wherein the analyte sensor port comprises a first contact structure and a second contact structure configured to contact the insertion monitor.

8. The apparatus of claim 1, further comprising the in vitro analyte sensor positioned with the analyte sensor port.

9. The apparatus of claim 1, wherein the in vitro analyte sensor is a calibration-adjusted in vitro analyte sensor having a predetermined calibration parameter corresponding to the stored calibration parameter stored in memory.

10. The apparatus of claim 1, wherein the at least one calibration parameter is a universal calibration parameter used with a calibration-adjusted analyte sensor having a predetermined calibration parameter corresponding to the stored calibration parameter stored in memory.

11. The apparatus of claim 1, wherein the processor is configured to validate the data by determining whether a rate of change of analyte signals from the transcutaneous analyte sensor is within a predetermined acceptable range.

12. The apparatus of claim 1, wherein the processor is configured to validate the data by determining whether the analyte signal from the transcutaneous analyte sensor is within a predetermined acceptable analyte signal range.

13. The apparatus of claim 1, wherein the processor is configured to validate the data relating to analyte signals from the transcutaneous analyte sensor prior to recommending and/or executing a therapy action based on data relating to analyte signals from the transcutaneous analyte sensor.

14. The apparatus of claim 1, wherein the rf receiver is configured to receive data transmitted by the transmitter at predetermined time intervals.

15. The apparatus of claim 1, wherein the analyte is glucose.

16. The apparatus of claim 1 wherein the stored calibration parameter includes a calibration code.

17. A method, comprising:

detecting a presence of an in vitro analyte test strip having a fluid sample thereon using an integrated monitor connected to a strip port configured for receiving the test strip;

processing one or more signals generated by the test strip based on the fluid sample using the integrated monitor; and

wirelessly receiving a time spaced signals from a transmitter using the integrated monitor, each received time spaced signals corresponding to a monitored analyte level;

wherein processing the one or more signals generated by the test strip includes retrieving a calibration parameter from a memory device disposed within the integrated monitor upon detection of the presence of the in vitro test strip, and determining a corresponding analyte level based on the one or more signals generated by the test strip.

18. The method of claim 17 including calibrating the one or more signals generated by the test strip automatically based on the retrieved calibration parameter using the integrated monitor without user interaction.

19. The method of claim 17 including calibrating the received time spaced signals using the integrated monitor based on the determined corresponding analyte level.

20. An apparatus, comprising:

an integrated housing including;

a test strip interface coupled to the housing;

one or more processors disposed in the housing; and

a memory disposed in the housing and for storing instructions which,

when executed by the one or more processors, causes the one or more processors to detect a presence of an in vitro analyte test strip having a fluid sample thereon received at the test strip interface, to process one or more signals generated by the test strip based on the fluid sample, to process plurality of wirelessly received, time spaced signals from a remote location, each time spaced signal corresponding to a monitored analyte level, to retrieve a calibration parameter from the memory upon detection of the presence of the in vitro test strip at the test strip interface, and to determine a corresponding analyte level based on the one or more signals generated by the test strip.

21. The apparatus of claim 20 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to calibrate the one or more signals generated by the test strip automatically based on the retrieved calibration parameter without user interaction.

22. The apparatus of claim 20 wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to calibrate the received time spaced signals based on the determined corresponding analyte level.