# US 11,076,785 B2 · Method and apparatus for providing data processing and control in a medical communication system

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- Number: US 11,076,785 B2
- Document ID: US11076785B2
- Status: Granted
- Kind: B2
- Application number: 15/681,345
- Filed: 2017-08-19
- Published: 2017-11-30
- Granted: 2021-08-03
- Earliest claimed: 2007-05-14
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Gary Alan Hayter; Geoffrey V. McGarraugh; Kenneth J. Doniger
- Web page: https://patentgrep.com/patent/US11076785B2

## CPC

- A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase
- A61B 5/0008: {Temperature signals}
- A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/1451: {for interstitial fluid}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- 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 5/4845: {Toxicology, e.g. by detection of alcohol, drug or toxic products (A61B5/4848 takes precedence)}
- 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}
- G16H 40/63: for local operation
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B 2560/0242: adapted to measure environmental factors, e.g. temperature, pollution
- A61B 2560/0276: Determining malfunction
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

## Claims

### Claim 1

An apparatus, comprising:
a data communication unit configured to wirelessly receive data corresponding to a monitored analyte level, the data generated using analyte sensor signals from an in vivo analyte sensor positioned in contact with biofluid under a skin surface, the received data including analyte data indicative of the monitored analyte level and one or more error indicators generated by the analyte sensor in response to detection of an error condition during measurement;
a memory device configured to store the received data; and
a data processing unit operatively coupled to the data communication unit and the memory device, the data processing unit configured to:
determine the monitored analyte level from the received analyte data;
determine one or more valid data points over a period of time based on the received data and the one or more error indicators;
determine a number of the error indicators received over the period of time;
and
determine a rate of change of the monitored analyte level based on the one or more valid data points when the number of the one or more error indicators received over the period of time are less than a predetermined amount.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the biofluid is interstitial fluid.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the analyte is either lactate or glucose.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the data communication unit is configured to wirelessly receive the data corresponding to the monitored analyte level using a communication protocol, the communication protocol being one of an RF communication protocol, an infrared communication protocol, an 802.11x wireless communication protocol, or an IEEE 802.15.4-based protocol such as ZIGBEE transmission protocol.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the one or more error indicators comprise one or more error flags in one or more data fields of the received data.

### Claim 6 (depends on 1)

The apparatus of claim 1, wherein the data processing unit is configured to postpone a rate of change determination when the one or more error indicators are less than the predetermined amount.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein the in vivo analyte sensor comprises a plurality of electrodes including a working electrode comprising a glucose-responsive enzyme bonded to a polymer disposed on the working electrode.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein the glucose-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

### Claim 9 (depends on 7)

The apparatus of claim 7, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

### Claim 10 (depends on 9)

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

### Claim 11

A system, comprising:
an in vivo analyte sensor positioned in contact with biofluid under a skin surface to generate analyte sensor signals corresponding to a monitored analyte level;
a transmitter unit operatively coupled to the in vivo analyte sensor to receive the analyte sensor signals and generate data corresponding to the monitored analyte level, the data including analyte data indicative of the monitored analyte level and one or more error indicators generated by the analyte sensor in response to detection of an error condition during measurement; and
a receiving device communicatively coupled to the transmitter unit, the receiving device comprising:
a data communication unit configured to wirelessly receive the data corresponding to the monitored analyte level, wherein the received data includes the analyte data and the one or more error indicators;
a memory device configured to store the received data; and
a data processing unit operatively coupled to the data communication unit and the memory device, the data processing unit configured to:
determine the monitored analyte level from the received analyte data;
determine one or more valid data points over a period of time based on the received data and the one or more error indicators;
determine a number of the one or more error indicators received over the period of time; and
determine a rate of change of the monitored analyte level based on the one or more valid data points when the number of the one or more error indicators received over the period of time are less than a predetermined amount.

### Claim 12 (depends on 11)

The system of claim 11, wherein the biofluid is interstitial fluid.

### Claim 13 (depends on 11)

The system of claim 11, wherein the analyte is either lactate or glucose.

### Claim 14 (depends on 11)

The system of claim 11, wherein the data communication unit is configured to wirelessly receive the data corresponding to the monitored analyte level using a communication protocol, the communication protocol being one of an RF communication protocol, an infrared communication protocol, or an 802.11x wireless communication protocol, or an IEEE 802.15.4-based protocol such as ZIGBEE transmission protocol.

### Claim 15 (depends on 11)

The system of claim 11, wherein the one or more error indicators comprise one or more error flags in one or more data fields of the received data.

### Claim 16 (depends on 11)

The system of claim 11, wherein the data processing unit is configured to postpone a rate of change determination when the one or more error indicators are less than the predetermined amount.

### Claim 17 (depends on 11)

The system of claim 11, wherein the in vivo analyte sensor comprises a plurality of electrodes including a working electrode comprising a glucose-responsive enzyme bonded to a polymer disposed on the working electrode.

### Claim 18 (depends on 17)

The system of claim 17, wherein the glucose-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

### Claim 19 (depends on 17)

The system of claim 17, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

### Claim 20 (depends on 19)

The system of claim 19, wherein the mediator is crosslinked with the polymer disposed on the working electrode.
