Analyte monitoring device and methods of use

• US 8,915,850 B2
• Filed: 03/28/2014
• Issued: 12/23/2014
• Est. Priority Date: 11/01/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Adam, Feldman, Benjamin Jay, Karinka, Shridhara Alva, Wang, Yi, Galasso, John R.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US14/229,520
• Publication Number:
  US 20140213868A1
• Time in Patent Office: 270 Days
• Field of Search: 600/309, 600345-366
• US Class Current: 600/365
• 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, comprising:

a data receiver configured to receive data relating to analyte levels from a transcutaneous analyte sensor;

an analyte sensor interface configured to receive an in vitro analyte sensor, wherein the in vitro analyte sensor generates an analyte signal from a fluid sample;

a memory configured to store a universal calibration parameter associated with all in vitro analyte sensors that are no-coding in vitro analyte sensors; and

a processor operatively coupled to the data receiver and the memory, the processor configured to validate the data relating to the analyte levels from the transcutaneous analyte sensor based at least in part on the analyte signal generated by the in vitro analyte sensor, to recognize the in vitro analyte sensor without a user inputting information when the in vitro analyte sensor is received in the analyte sensor interface and is a no-coding in vitro analyte sensor, and to retrieve the universal calibration parameter stored in the memory when the recognized in vitro analyte sensor is the no-coding in vitro analyte sensor.

2. The apparatus of claim 1, wherein the analyte sensor interface comprises a first contact structure and a second contact structure configured to contact the in vitro analyte sensor.

3. The apparatus of claim 1, wherein the in vitro analyte sensor is a calibration-adjusted in vitro analyte sensor.

4. The apparatus of claim 1, wherein the universal calibration parameter stored in the memory includes a universal calibration code.

5. The apparatus of claim 1, wherein the transcutaneous analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode.

6. The apparatus of claim 5, wherein the at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

7. The apparatus of claim 1, wherein the universal calibration parameter stored in the memory is a standard calibration code, and the in vitro analyte sensor is manufactured to fit the standard calibration code.

8. The apparatus of claim 1, wherein the transcutaneous analyte sensor is configured to monitor one or more of glucose level, lactate level, or oxygen level in interstitial fluid or blood.

9. The apparatus of claim 1, wherein the universal calibration parameter is stored in the memory prior to receipt of the in vitro analyte sensor in the analyte sensor interface.

10. The apparatus of claim 1, wherein the data receiver includes a wireless data communication unit.

11. A method, comprising:

determining, using one or more processors, a type of in vitro analyte sensor upon detecting a presence of the in vitro analyte sensor received at an analyte sensor interface configured for receiving the in vitro analyte sensor;

recognizing, using the one or more processors, the in vitro analyte sensor without a user inputting information when the in vitro analyte sensor is a no-coding in vitro analyte sensor;

retrieving, using the one or more processors, a stored universal calibration parameter from a memory when the recognized in vitro analyte sensor is the no-coding in vitro analyte sensor, wherein the stored universal calibration parameter is associated with all in vitro analyte sensors that are no-coding in vitro analyte sensors;

determining, using the one or more processors, a corresponding analyte level based on one or more signals generated by the in vitro analyte sensor and the retrieved universal calibration parameter; and

processing, using the one or more processors, one or more time spaced signals from a remote location associated with a monitored analyte level from a transcutaneous analyte sensor based on a signal generated by the in vitro analyte sensor.

12. The method of claim 11, wherein the transcutaneous analyte sensor includes a plurality of electrodes, wherein the plurality of electrodes include a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode.

13. The method of claim 12, wherein the at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

14. The method of claim 11, wherein the universal calibration parameter stored in the memory is a standard calibration code, and the in vitro analyte sensor is manufactured to fit the standard calibration code.

15. The method of claim 11, wherein the monitored analyte level is related to one or more of glucose level, lactate level, or oxygen level in interstitial fluid or blood.

16. An apparatus, comprising:

an in vitro analyte sensor interface;

one or more processors operatively coupled to the in vitro analyte sensor interface; and

a memory operatively coupled to the one or more processors, the memory 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 sensor received at the in vitro analyte sensor interface, to determine a type of in vitro analyte sensor upon detecting the presence of the in vitro analyte sensor, to process one or more signals generated by the in vitro analyte sensor, to process a plurality of wirelessly received time spaced signals from a remote location, each time spaced signal corresponding to a monitored analyte level, wherein the memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to recognize the type of in vitro analyte sensor without a user inputting information when the in vitro analyte sensor is a no-coding in vitro analyte sensor, and to retrieve a stored universal calibration parameter from the memory when the recognized in vitro analyte sensor is the no-coding in vitro analyte sensor, wherein the stored universal calibration parameter is associated with all in vitro analyte sensors that are no-coding in vitro analyte sensors and the retrieved universal calibration parameter is stored in the memory prior to detecting the presence of the in vitro analyte sensor.

17. The apparatus of claim 16, 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 in vitro analyte sensor automatically based on the retrieved universal calibration parameter without user interaction when the type of in vitro analyte sensor is determined.

18. The apparatus of claim 16, wherein the plurality of wirelessly received time spaced signals from the remote location are related to analyte signals from a transcutaneous analyte sensor that includes a plurality of electrodes, wherein the plurality of electrodes include a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, and wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode.

19. The apparatus of claim 18, wherein the at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

20. The apparatus of claim 16, wherein the universal calibration parameter stored in the memory is a standard calibration code, and the in vitro analyte sensor is manufactured to fit the standard calibration code.