Drive Train Actuation Failure Handling in Multi-Reservoir Medical Devices

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Solution Overview

Problem

Current medical devices for delivering multiple medicaments in a single injection step are complex and lack effective failure handling mechanisms, particularly for blocked needles, which can lead to underdosing and user safety issues.

Innovation Solution

A medical device with a micro-processor controlled drive train for automatic ejection of fluids from separate reservoirs, featuring a control unit that detects drive train actuation failures and prompts user intervention for disposable assembly replacement, ensuring proper functioning and user safety through sequential failure handling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a single injection step delivers multiple medicaments, then user convenience and treatment efficiency are improved, but device complexity increases

Engineering Contradiction:
Improvetreatment efficiencyVSAvoiddevice complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The device is divided into separate functional modules: a reusable body containing the drive train and control unit, and replaceable cartridges containing different medicaments. This segmentation allows the complex multi-medicament delivery function to be achieved through standardized, interchangeable components rather than a monolithic complex device.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The reusable body is designed with universal functionality to work with multiple types of cartridges containing different medicaments. The drive train and control unit serve multiple purposes: driving the plunger, detecting blockages, and managing the injection process regardless of which cartridge is installed, thereby achieving multi-medicament delivery through a universal platform.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If automatic ejection is implemented, then user safety and dosing accuracy are improved, but device complexity increases

Engineering Contradiction:
Improvedosing accuracyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The drive train incorporates self-diagnostic capabilities through sensors that automatically detect blockages and injection failures without user intervention. The system monitors its own operation, detects anomalies such as blocked needles or cartridge issues, and communicates these to the user through the interface, enabling automatic safety monitoring without adding significant complexity.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The control unit receives feedback from sensors during the injection process, monitoring parameters such as injection pressure and flow. This feedback loop allows the system to detect blockages in real-time, verify successful medicament delivery, and alert the user to any issues, thereby ensuring dosing accuracy through automated monitoring.

Inventive Principle:
Principle #23Feedback

3Reliability

If failure detection mechanisms are added, then user safety is improved, but device complexity increases

Engineering Contradiction:
Improveuser safetyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system performs preliminary checks before and during injection to detect potential failures. The control unit monitors injection progress and detects blockages proactively rather than waiting for injection completion. This preliminary detection approach enhances user safety by identifying issues early while keeping the detection mechanism integrated into the existing drive train operation.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3043839B1Actuation step failure handling
Publication Date: 2019.10.23 SANOFI AVENTIS DEUT GMBH
  • EP3043839B1 patent drawingFigure 1
  • EP3043839B1 patent drawingFigure 2~3
  • EP3043839B1 patent drawingFigure 4

AI summary

The invention relates to an apparatus for automatic ejection of a fluid, having a drive train for automatically ejecting the fluid from a fluid reservoir through an ejection channel, and having a control unit (510) for controlling the apparatus, the control unit (510) being configured to detect failures of drive train actuation steps (610, 620), during which the drive train is actuated for priming or fluid dose ejection, the control unit (510) being further configured to control the apparatus as a function of an actuation step failure number, the actuation step failure number being the number of failed drive train actuation steps (610, 620) since the last successful drive train actuation step (610, 620). The invention further relates to a system comprising such an apparatus a disposable assembly attachable to the apparatus and to a method for controlling such an apparatus.