Motion Sensing Unit for Injection Pen Protocol Data

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Solution Overview

Problem

Patients using multiple daily injection (MDI) therapy for medicaments like insulin face challenges in accurately and consistently recording protocol data, leading to potential errors in dosage and timing, which can result in serious complications such as hypoglycemic coma due to incorrect or missed injections.

Innovation Solution

A device equipped with a motion sensing unit including a gyroscope and accelerometer generates protocol data by analyzing signals from the injection pen's dosing and delivery mechanisms, providing accurate records of adjusted dosages and delivery times, adaptable to various types of injection pens and capable of transmitting data to external devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If patients manually record protocol data in a diary or portable electronic device, then they can track injection dosages and timing, but the recording accuracy and consistency deteriorate due to human error and forgetfulness

Engineering Contradiction:
Improveprotocol data recording accuracyVSAvoiddosage and timing recording precision
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The injection pen automatically records protocol data (dosage, timestamp, injection events) without requiring patient manual input. The device self-monitors its own operation through sensors that detect dosing wheel rotation, push-button activation, and needle insertion/retraction events, eliminating human error in data recording

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces manual mechanical recording (writing in diary) with electronic sensing and automated data capture. Sensors detect mechanical movements of the injection mechanism and automatically convert them into digital protocol data, substituting human manual operations with automated electronic systems

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Ease of operation

If patients delay injections due to external circumstances, then they can attend to immediate obligations, but the timing accuracy of protocol data deteriorates

Engineering Contradiction:
Improveflexibility in injection timingVSAvoidinjection timing precision
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The device provides real-time feedback through alarms and notifications to remind patients of scheduled injections. The system continuously monitors the current time against scheduled injection times and provides timely alerts, enabling patients to maintain accurate timing even when occupied with other activities

Inventive Principle:
Principle #23Feedback

3Productivity

If patients incorrectly adjust dosage or retract pen too early, then injection process continues, but dosage accuracy deteriorates leading to potential harm

Engineering Contradiction:
Improveinjection delivery completionVSAvoiddosage delivery precision
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The device provides real-time feedback during the injection process by monitoring sensor data (push-button position, needle retraction status, dosage wheel position). The system can detect incomplete injections or incorrect dosage adjustments and alert the patient, preventing harmful errors before they occur

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The device implements preliminary error prevention by validating dosage settings before injection delivery and monitoring injection completion throughout the process. The system prevents incorrect dosage administration by verifying dosing wheel position and push-button activation patterns before allowing medicament delivery

Inventive Principle:
Principle #9Preliminary anti-action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The device ensures accurate and reliable recording of injection data, reducing the risk of errors and complications by automatically generating and transmitting protocol data, including dosage and timing information, thus enhancing patient safety and adherence to treatment regimens.

Implementation Method 1

a motion sensing unit including a gyroscope and an accelerometer in order to generate a gyro signal and an acceleration signal

Methodology Applied
Scientific EffectGyroscope: Gyroscope

Implementation Method 2

a motion sensing unit including a gyroscope and an accelerometer in order to generate a gyro signal and an acceleration signal

Methodology Applied
Scientific EffectAccelerometer: Accelerometer

Data Source

PatentEP3484555B1Device for generating protocol data for an injection pen
Publication Date: 2023.11.29 ROCHE DIABETES CARE GMBH
  • EP3484555B1 patent drawingFigure 1~2b
  • EP3484555B1 patent drawingFigure 3a~4
  • EP3484555B1 patent drawingFigure 5~6

AI summary

The invention concerns a device (1) for generating protocol data for an injection pen (2). The device (1) comprises a motion sensing unit (13) including one or more of a gyroscope and an accelerometer in order to generate one or more of a gyro signal and an acceleration signal. The device comprises a signal processing unit ( 14) which implements an analyser which is configured to analyse one or more of the gyro signal and the acceleration signal and to generate protocol data reflecting an adjusted dosage of a medicament. Optionally, the analyser is configured to generate protocol data reflecting delivery of the adjusted dosage of the medicament.