# US 10,119,956 B2 · Method and apparatus for providing data processing and control in a medical communication system

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- Number: US 10,119,956 B2
- Document ID: US10119956B2
- Status: Granted
- Kind: B2
- Application number: 15/796,274
- Filed: 2017-10-27
- Published: 2018-03-01
- Granted: 2018-11-06
- Earliest claimed: 2007-05-14
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Gary Alan Hayter; Geoffrey V. McGarraugh; Andrew H. Naegeli; John Charles Mazza; Benjamin Jay Feldman
- Web page: https://patentgrep.com/patent/US10119956B2

## CPC

- G01N 33/49: Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/1495: Calibrating or testing of in-vivo probes
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 40/67: for remote operation
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B 2560/0252: using ambient temperature
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 50/50: for simulation or modelling of medical disorders
- 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)
- 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 for data processing and control for a medical communication system are provided, including determining a sensitivity value for each sensor of a batch of in vivo analyte sensors; determining a sensitivity variation for each sensor of the batch; determining a mean sensitivity based on the sensitivity value determined for each sensor of the batch when it is determined that the determined sensitivity variation does not exceed a tolerance threshold level; associating a sensor code with each sensor of the batch of in vivo analyte sensors when the mean sensitivity is within a predetermined sensitivity range, wherein the sensor code associated with each sensor is based on a characteristic of the associated sensor; and storing the sensor code associated with at least one sensor of the batch configured to generate signals corresponding to monitored analyte level in a memory of a data processing device associated with the sensor.

## Claims

### Claim 1

A method, comprising:
determining a sensitivity value for each sensor of a batch of in vivo analyte sensors;
determining a sensitivity variation for each sensor of the batch of in vivo analyte sensors;
determining a mean sensitivity based on the sensitivity value determined for each sensor of the batch of in vivo analyte sensors when it is determined that the determined sensitivity variation does not exceed a tolerance threshold level;
associating a sensor code with each sensor of the batch of in vivo analyte sensors when the mean sensitivity is within a predetermined sensitivity range, wherein the sensor code associated with each sensor of the batch of in vivo analyte sensors is based on a characteristic of the associated sensor; and
storing the sensor code associated with at least one sensor of the batch of in vivo analyte sensors configured to generate signals corresponding to monitored analyte level in a memory of a data processing device associated with the sensor.

### Claim 2 (depends on 1)

The method of claim 1, wherein the analyte of the in vivo analyte sensors is one of glucose or lactate.

### Claim 3 (depends on 1)

The method of claim 1, wherein the sensor code associated with each sensor of the batch of in vivo analyte sensors is based on a sensitivity of the sensor, and wherein the sensor code corresponds to a sensitivity range.

### Claim 4 (depends on 1)

The method of claim 1, further comprising labeling a sensor packaging for the batch of in vivo analyte sensors with the sensor code.

### Claim 5 (depends on 1)

The method of claim 1, further comprising performing a retrospective analyte level determination using the sensor code.

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 6)

The method of claim 6, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

### Claim 8 (depends on 6)

The method of claim 6, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

### Claim 9 (depends on 8)

The method of claim 8, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

### Claim 10 (depends on 1)

The method of claim 1, wherein each analyte sensor of the batch of in vivo analyte sensors comprises a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.

### Claim 11

A method, comprising:
determining a sensitivity value for each sensor of a batch of in vivo analyte sensors;
determining a sensitivity variation for each sensor of the batch of in vivo analyte sensors;
determining a mean sensitivity based on the sensitivity value determined for each sensor of the batch of in vivo analyte sensors when it is determined that the determined sensitivity variations each do not exceed a tolerance threshold level;
associating a sensor code with each sensor of the batch of in vivo analyte sensors when the mean sensitivity is within a predetermined sensitivity range;
generating signals corresponding to a monitored analyte level of a user using at least one sensor of the batch of in vivo analyte sensors; and
storing the sensor code associated with the at least one sensor of the batch of in vivo analyte sensors configured to generate the signals corresponding to the monitored analyte level in a memory of a data processing device associated with the sensor.

### Claim 12 (depends on 11)

The method of claim 11, wherein the analyte of the in vivo analyte sensors is one of glucose or lactate.

### Claim 13 (depends on 11)

The method of claim 11, wherein the sensor code corresponds to the predetermined sensitivity range.

### Claim 14 (depends on 11)

The method of claim 11, further comprising determining, using the data processing device and the sensor code, an updated sensitivity for the at least one sensor of the batch of in vivo analyte sensors; and calibrating, using the data processing device and the updated sensitivity, the generated signals to obtain the monitored analyte level.

### Claim 15 (depends on 14)

The method of claim 14, further comprising performing a retrospective analyte level determination using the updated sensitivity.

### Claim 16 (depends on 11)

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

### Claim 17 (depends on 16)

The method of claim 16, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

### Claim 18 (depends on 16)

The method of claim 16, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

### Claim 19 (depends on 18)

The method of claim 18, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

### Claim 20 (depends on 11)

The method of claim 11, wherein each analyte sensor of the batch of in vivo analyte sensors comprises a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.
