Wearable Injector Sterility Monitoring With Breakable Circuits

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Solution Overview

Problem

Existing on-body drug delivery devices lack mechanisms to ensure sterility has not been compromised, potentially allowing non-sterile use and failure to alert healthcare professionals or patients.

Innovation Solution

Incorporation of breakable sterility sensor circuits in the drug delivery device, which are activated or deactivated based on proper attachment and initial piston position, preventing operation if sterility is compromised and alerting through signals.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sterility sensor circuits are added to the device, then sterility monitoring capability is improved, but device complexity increases

Engineering Contradiction:

Improvesterility monitoringVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The sterility sensor circuit is implemented as a thin flexible printed circuit board (FPC) that can be integrated into the cartridge assembly. This flexible circuit board allows for monitoring sterility status while maintaining the compact and simple structure of the injection device, resolving the contradiction between adding monitoring capability and increasing device complexity.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent replaces complex mechanical sterility verification mechanisms with an electrical circuit-based detection system. The sterility sensor circuit uses electrical continuity or resistance changes to detect whether the cartridge has been improperly removed or compromised, substituting mechanical complexity with simpler electrical sensing.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If breakable sterility sensor circuits are implemented, then sterility assurance is improved, but manufacturing complexity increases

Engineering Contradiction:

Improvesterility assuranceVSAvoidease of manufacture

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The sterility sensor circuit is pre-configured and sealed within the cartridge assembly during manufacturing. The circuit is designed to be broken or disconnected only under specific conditions (such as improper cartridge removal), allowing sterility assurance to be built-in during assembly without requiring complex post-manufacturing verification processes.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The sterility sensor circuit is implemented as a disposable component integrated into the single-use cartridge. This approach allows for simplified manufacturing of the sensor itself, as it does not need to be durable or reusable, and can be easily disposed of after a single use, reducing overall manufacturing complexity.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Object-affected harmful factors

If sterility monitoring signals are added, then safety alerting is improved, but device complexity increases

Engineering Contradiction:

Improvesafety alertingVSAvoiddevice complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The sterility sensor circuit shares the existing communication interface and signal processing pathways of the injection device. The same microcontroller and display systems that monitor injection parameters are also used to detect and alert on sterility status, allowing safety alerting functionality to be added without proportionally increasing device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The sterility monitoring function is merged with the existing device control and display system. Rather than adding separate alerting hardware, the patent integrates sterility status detection into the existing user interface and control logic, combining multiple functions into shared system components to minimize complexity increases.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS12420033B1Wearable injector with sterility sensors

Publication Date: 2025.09.23 FRESENIUS KABI DEUTSCHLAND GMBH

AI summary

An on-body drug delivery device having a housing and a cartridge removably attachable to the housing. The cartridge comprises: a drug chamber, a piston received in the drug chamber movable from a first, initial position to a second position, an actuation device for moving the piston from the first position to the second position, and at least one breakable sterility sensor circuit formed by attachment of the cartridge to the housing, the circuit being closed when the cartridge is properly attached to the housing and broken if the cartridge is not properly attached to the housing or removed from the housing after being attached thereto, and/or the circuit being broken if the piston is not in the initial position when the cartridge is first attached to the housing.