# US 2010/0168658 A1 · Analyte Monitoring Device and Methods of Use

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- Number: US 2010/0168658 A1
- Document ID: US20100168658A1
- Status: Published application
- Kind: A1
- Application number: 12/643,977
- Filed: 2009-12-21
- Published: 2010-07-01
- Earliest claimed: 1998-04-30
- Assignees: Abbott Diabetes Care Inc.
- Inventors: James Say; Michael F. Tomasco; Adam Heller; Yoram Gal; Behrad Aria; Ephraim Heller; Phillip John Plante; Mark S. Vreeke; Keith A. Friedman; Fredric C. Colman
- Web page: https://patentgrep.com/patent/US20100168658A1

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/1451: {for interstitial fluid}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/4839: {combined with drug delivery}
- A61B 5/72: {Signal processing specially adapted for physiological signals or for diagnostic purposes}
- 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 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- A61B 5/7445: {Display arrangements, e.g. multiple display units}
- A61B 5/7455: {characterised by tactile indication, e.g. vibration or electrical stimulation}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- C12Q 1/54: involving glucose or galactose
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 20/17: delivered via infusion or injection
- H10W 70/424: {Cross-sectional shapes (H10W70/481 takes precedence)}
- H10W 74/111: {the semiconductor body being completely enclosed}
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 2560/0252: using ambient temperature
- Y10S 128/903: Radio telemetry
- Y10T 29/49: Method of mechanical manufacture
- Y10T 29/49124: On flat or curved insulated base, e.g., printed circuit, etc.
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H10W: GENERIC PACKAGES, INTERCONNECTIONS, CONNECTORS OR OTHER CONSTRUCTIONAL DETAILS OF DEVICES COVERED BY CLASS H10
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

## Claims

### Claim 1

A system for communicating with an external infusion pump, comprising:
a housing including an in vitro glucose monitor and a processor operatively coupled to the in vitro glucose monitor and disposed in the housing, the processor configured to generate a reading associated with an analyte concentration based on a blood sample from an in vitro test strip; and
a drug administration system configured to receive the generated reading from the processor and to execute a drug administration protocol.

### Claim 2 (depends on 1)

The system of claim 1 wherein the housing includes a data communication port.

### Claim 3 (depends on 1)

The system of claim 1 further including an RF transmitter operatively coupled to the housing.

### Claim 4 (depends on 1)

The system of claim 1 wherein the generated reading is transmitted using one or more of an RF transmission, an optical transmission, or a wired transmission.

### Claim 5 (depends on 1)

The system of claim 1 wherein the in vitro glucose monitor includes a calibration unit.

### Claim 6 (depends on 1)

The system of claim 1 including a display operatively coupled to the housing and configured to output one or more of a visual, auditory or vibratory output associated with the generated reading.

### Claim 7 (depends on 1)

The system of claim 1 wherein the generated reading includes blood glucose level information.

### Claim 8 (depends on 1)

The system of claim 1 including a data storage unit operatively coupled to the housing and configured to store one or more of the generated reading, the associated analyte concentration, information related to the blood sample or information related to the drug administration protocol.

### Claim 9 (depends on 8)

The system of claim 8 wherein the information related to the blood sample includes one or more of a time stamp, a date stamp, or a calibration code associated with the in vitro glucose monitor.

### Claim 10 (depends on 8)

The system of claim 8 wherein the information related to the drug administration protocol includes one or more of a drug sensitivity curve, a duration of the drug administration protocol, a patient profile, food intake information, exercise information, fasting information, body temperature information, drug sensitivity feedback information or one or more subsequent drug administration protocols.

### Claim 11 (depends on 1)

The system of claim 1 including an input unit operatively coupled to the housing, the processor configured to detect one or more input signals generated by the input unit.

### Claim 12 (depends on 11)

The system of claim 11 wherein the one or more input signals includes an event marker.

### Claim 13 (depends on 1)

The system of claim 1 including an alarm system operatively coupled to the housing and configured to generate one or more notifications.

### Claim 14 (depends on 13)

The system of claim 13 wherein the alarm system is triggered when a predetermined condition is detected by the processor.

### Claim 15 (depends on 1)

The system of claim 1 wherein the drug administration system includes one or more of an external infusion pump, an internal infusion pump, a syringe injector, a transdermal delivery system, or an inhalation system.

### Claim 16 (depends on 1)

The system of claim 1 wherein the drug administration system is configured to determine the drug administration protocol based at least on the generated reading associated with the analyte concentration.

### Claim 17 (depends on 1)

The system of claim 1 wherein the analyte concentration includes glucose concentration.

### Claim 18 (depends on 1)

The system of claim 1 wherein the processor is further configured to process data received from a sensor control unit.

### Claim 19 (depends on 18)

The system of claim 18 wherein the data received from the sensor control unit includes analyte sensor data.

### Claim 20 (depends on 18)

The system of claim 18 wherein the data from the sensor control unit is wirelessly received by the processor.
