Insertion Device Actuator Arm Locking Mechanism
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Solution Overview
Problem
Existing insertion devices for analyte sensors face challenges such as complexity in setup, loss of parts, difficulty in handling for elderly or handicapped individuals, increased pain due to over-dimensioned spring pre-tensioning, and risks of misuse and contamination.
Innovation Solution
A mechanical insertion device with a pivotable actuator arm and locking mechanism that prevents back-pivoting after a threshold angle, combined with a safety lock to prevent unwanted reuse, allowing for easy and painless insertion of analyte sensors into body tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a pre-tensioned spring element is used to ensure sufficient penetration force for any skin type, then the insertion force is increased, but the subjective feeling of pain increases due to impetuous abutment on the stopper
Solution Approach 1:
The spring element is designed to be non-pre-tensioned and only activated during the insertion process itself. The spring force is dynamically applied as the actuator arm pivots, allowing the insertion force to build progressively rather than being applied impetuously from a pre-tensioned state, thereby reducing pain while ensuring sufficient penetration force
2Ease of operation
If the insertion device allows multiple handling steps for proper operation, then the insertion process can be controlled, but it provides severe difficulties for children, elderly persons or handicapped persons
Solution Approach 1:
Multiple functions are merged into a single integrated actuator arm mechanism. The actuator arm simultaneously performs: (1) releasing the safety lock, (2) driving the insertion needle holder through pivoting motion, (3) engaging the locking mechanism, and (4) triggering the analyte sensor insertion. This consolidation reduces the number of separate handling steps while maintaining controlled insertion process
Solution Approach 2:
The actuator arm is designed as a multi-functional component that performs multiple operations in sequence: it acts as a safety release trigger, a drive mechanism for the insertion needle, a locking engagement actuator, and a force transmission element. This multi-functionality simplifies the overall device operation for users while maintaining precise control over the insertion process
3Ease of operation
If the insertion device is designed with simple setup and fewer parts, then ease of operation is improved, but protection against reuse and misuse becomes insufficient
Solution Approach 1:
The locking mechanism is pre-configured to automatically engage at a predetermined threshold angle of the actuator arm pivoting motion. This preliminary action ensures that once the actuator arm reaches the threshold angle, the locking mechanism irreversibly locks, preventing any back-pivoting or reuse attempts. The safety lock is also pre-positioned to block rotor rotation before insertion occurs, providing built-in protection against misuse without adding complex user-operated safety features
4Ease of operation
If the actuator arm can pivot freely in both directions, then ease of actuation is improved, but back-pivoting after insertion creates risk of reuse and contamination
Solution Approach 1:
The actuator arm's pivoting motion is segmented into distinct phases: a free-pivoting phase before insertion that allows easy actuation, and a locked phase after reaching the threshold angle that prevents back-pivoting. The locking mechanism creates a clear division between these phases, permitting forward motion for insertion while blocking reverse motion to prevent reuse and contamination
Data Source
AI summary
An insertion device (110) for inserting an analyte sensor (114) into a body tissue is proposed. The insertion device (110) comprises an insertion needle holder (120) and a drive mechanism (124) for linearly driving the insertion needle holder (120) in a longitudinal direction (126). The drive mechanism (124) comprises at least one actuator (132) for actuating the drive mechanism (124). The actuator (132) comprises at least one actuator arm (136, 138) which is pivotable about at least one axle (140) in order to actuate the drive mechanism (124). The insertion device (110) further comprises at least one protection against reuse including at least one locking mechanism (178). The locking mechanism (178) is adapted to at least partially prevent a back-pivoting of the actuator arm (136, 138) in a direction reversing the actuation direction once the actuator arm (136, 138) has been pivoted by at least one threshold angle.


