Analyte Sensor Initialization via Remote Database

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Solution Overview

Problem

Existing analyte measurement systems for continuous glucose monitoring are complex and costly to initialize, particularly due to the need for manual input or separate data storage devices, which complicates the manufacturing process and user application.

Innovation Solution

A method that utilizes a remote database to store initialization data sets for analyte sensors, with a control device reading a machine-readable sensor identifier from a patch device and transmitting it to the database to retrieve matching initialization data, which are then stored temporarily in a writable memory within the patch device's electronics unit.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If initialization data are stored in a pre-programmed memory device (ROM) provided with each sensor, then the data storage is integrated with the sensor, but the device complexity increases due to additional manufacturing, programming, and supply of the memory device, and the patch device requires additional electrical and mechanical interfaces

Engineering Contradiction:
Improvemanufacturing complexityVSAvoiddevice complexity
Core Design Contradiction:
Ease of manufactureVSDevice complexity

Solution Approach 1:

The patent extracts the initialization data storage from the sensor itself and places it in an external database system. The sensor only retains a minimal identifier, while the actual initialization data are stored externally and transferred wirelessly. This removes the need for complex integrated memory devices and their associated interfaces, thereby reducing device complexity while maintaining ease of manufacture.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an external database system as an intermediary between the sensor manufacturing process and the final sensor deployment. This mediator stores initialization data centrally and provides them to sensors on-demand via wireless communication, eliminating the need for each sensor to have its own pre-programmed memory device and reducing overall system complexity.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If initialization data are directly stored into each disposable sensor during manufacturing, then the data are readily available for use, but the manufacturing process becomes comparatively complex

Engineering Contradiction:
Improveinitialization easeVSAvoidmanufacturing complexity
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

The patent performs preliminary preparation of initialization data in an external database before the sensor is actually used. The sensor receives only a minimal identifier during manufacturing, and the full initialization data are prepared and made available externally when needed. This separates the manufacturing simplicity from the operational readiness, achieving both goals.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Instead of embedding actual initialization data in each sensor during manufacturing, the patent uses a copying approach where a minimal identifier is placed in the sensor and the corresponding full initialization data are copied from an external database when the sensor is deployed. This maintains ease of operation while avoiding manufacturing complexity.

Inventive Principle:
Principle #26Copying

3Ease of manufacture

If a separate data storage device is provided with each sensor to store initialization data, then the data can be stored without complicating the sensor manufacturing, but the device complexity increases and additional interfaces are required

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoiddevice complexity
Core Design Contradiction:
Ease of manufactureVSDevice complexity

Solution Approach 1:

The patent merges the data storage function with the existing database infrastructure used for other purposes (such as sensor registration, tracking, or cloud-based monitoring). By combining initialization data storage with already-present database systems, the patent avoids adding separate storage devices and interfaces, thereby maintaining manufacturing simplicity while not increasing device complexity.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS11547327B2Analyte measurement system and initialization method
Publication Date: 2023.01.10 F HOFFMANN LA ROCHE & CO AG
  • US11547327B2 patent drawing
  • US11547327B2 patent drawing
  • US11547327B2 patent drawing

AI summary

Disclosed is a method for initializing an analyte measurement system (1, 2, 3), the analyte measurement system (1, 2, 3) being designed for continuous in-vivo measurement of a body fluid analyte concentration. The method including the steps of:a) providing the analyte measurement system (1, 2, 3,) with a control device (3) and a separate skin-mountable patch device (1, 2), the patch device (1, 2) including a disposable unit (1) and an electronics unit (2), the disposable unit (1) including a transcutaneous analyte sensor (10) and machine-readable sensor identifier (121), the electronics unit (2) being configured to releasable couple for an application time period to the disposable unit (1);b) providing a number of stored initialization data sets in a remote database system (4), each stored initialization data set comprising initialization data for an analyte sensor batch;c) reading, via a reading device (31) of the control device (3), the sensor identifier from the disposable unit (1) into the control device (3) and transmitting the sensor identifier to the remote database system;d) determining a matching initialization data set, the matching initialization data set being a stored initialization data set that matches the sensor identifier;e) transmitting the matching initialization data set from the remote database system to the control device (3);f) transmitting the matching initialization data set to the electronics unit (2) and storing the matching initialization data set in a memory (21) of the electronics unit (2).