# US 2019/0167165 A1 · Analyte Monitoring Device and Methods of Use

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- Number: US 2019/0167165 A1
- Document ID: US20190167165A1
- Status: Published application
- Kind: A1
- Application number: 16/271,378
- Filed: 2019-02-08
- Published: 2019-06-06
- Earliest claimed: 2005-11-01
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Adam Heller; Benjamin Jay Feldman; Shridhara Alva Karinka; Yi Wang; John R. Galasso
- Web page: https://patentgrep.com/patent/US20190167165A1

## CPC

- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/0031: {Implanted circuitry}
- A61B 5/1451: {for interstitial fluid}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/1477: non-invasive
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/7246: {using correlation, e.g. template matching or determination of similarity}
- 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}
- A61B 5/7278: {Artificial waveform generation or derivation, e.g. synthesizing signals from measured signals}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61B 5/7405: {using sound}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/7445: {Display arrangements, e.g. multiple display units}
- A61B 5/7455: {characterised by tactile indication, e.g. vibration or electrical stimulation}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- G01N 27/3272: {Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52)}
- G01N 27/3273: {Devices therefor, e.g. test element readers, circuitry (details not specific to biochemical electrodes G01N33/4875)}
- A61B 2017/3407: {including a base for support on the body}
- A61B 2017/3409: {including needle or instrument drives}
- A61B 2560/0209: adapted for power saving
- A61B 2560/0475: Special features of memory means, e.g. removable memory cards
- A61B 2562/0271: Thermal or temperature sensors
- A61B 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
- A61B 2562/085: combined with means for recording calibration data
- A61B 2562/125: characterised by the manufacture of electrodes
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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

### Claim 1

A method, comprising:
receiving an analyte sensor at an analyte sensor interface;
determining, using one or more processors, a type of the analyte sensor;
recognizing, using the one or more processors, the type of the analyte sensor without a user input as a no-coding analyte sensor; and
determining, using the one or more processors, an analyte level based on one or more signals generated by the analyte sensor and a universal calibration parameter that is associated with analyte sensors that are no-coding analyte sensors.

### Claim 2 (depends on 1)

The method of claim 1, further including wirelessly receiving an analyte related data from an in vivo analyte sensor in fluid contact with a bodily fluid.

### Claim 3 (depends on 2)

The method of claim 2, further including determining an analyte level in the bodily fluid in real time based on the received analyte related data.

### Claim 4 (depends on 3)

The method of claim 3, wherein the bodily fluid includes dermal fluid.

### Claim 5 (depends on 3)

The method of claim 3, wherein the bodily fluid includes interstitial fluid.

### Claim 6 (depends on 3)

The method of claim 3, wherein the analyte level is related to one or more of a glucose level, lactate level, or oxygen level.

### Claim 7 (depends on 3)

The method of claim 3, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme.

### Claim 8 (depends on 7)

The method of claim 7, wherein the enzyme is bound to a polymer disposed on the working electrode.

### Claim 9 (depends on 7)

The method of claim 7, wherein the working electrode comprises a mediator.

### Claim 10 (depends on 9)

The method of claim 9, wherein the mediator is bound to a polymer disposed on the working electrode.

### Claim 11 (depends on 9)

The method of claim 9, wherein the mediator is crosslinked with a polymer disposed on the working electrode.

### Claim 12 (depends on 3)

The method of claim 3, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising a mediator.

### Claim 13 (depends on 12)

The method of claim 12, wherein the mediator is bound to a polymer disposed on the working electrode.

### Claim 14 (depends on 12)

The method of claim 12, wherein the mediator is crosslinked with a polymer disposed on the working electrode.

### Claim 15

A method, comprising:
identifying, using one or more processors, an analyte sensor received at an analyte sensor interface of a display device without a user input as a no-coding analyte sensor;
determining, using the one or more processors, an analyte level based on one or more signals generated by the analyte sensor and a universal calibration parameter that is associated with analyte sensors that are no-coding analyte sensors; and
outputting the determined analyte level at an output unit operatively coupled to the one or more processors.

### Claim 16 (depends on 15)

The method of claim 15, further including wirelessly receiving an analyte related data from an in vivo analyte sensor in fluid contact with a bodily fluid.

### Claim 17 (depends on 16)

The method of claim 16, further including determining an analyte level in the bodily fluid in real time based on the received analyte related data.

### Claim 18 (depends on 17)

The method of claim 17, wherein the bodily fluid includes dermal fluid.

### Claim 19 (depends on 17)

The method of claim 17, wherein the bodily fluid includes interstitial fluid.

### Claim 20 (depends on 17)

The method of claim 17, wherein the analyte level is related to one or more of a glucose level, lactate level, or oxygen level.
