Lockout Mechanism Preventing Single-Use Device Reuse

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Solution Overview

Problem

Single-use medical devices intended for one patient may be reused, risking patient-to-patient contamination and equipment failure due to wear and tear, necessitating a mechanism to prevent reuse.

Innovation Solution

Incorporating a lockout mechanism with a biasing mechanism and movable slide element in single-use medical devices, which transitions between pre-use, in-use, and post-use configurations, preventing further use by mechanically disengaging from multi-use devices or physically disabling the device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If single use medical devices are made durable, then device strength and reusability improve, but patient safety deteriorates due to risk of contamination and equipment failure

Engineering Contradiction:
Improvedevice durabilityVSAvoidpatient safety
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The lockout mechanism is pre-configured to automatically transition from a first state (allowing use) to a second state (preventing reuse) after a single use cycle. This preliminary action ensures that even though the device is durable, it cannot be reused, thereby maintaining patient safety while utilizing durable materials.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If a lockout mechanism is added to prevent reuse, then patient safety improves, but device complexity increases

Engineering Contradiction:
Improvepatient safetyVSAvoidmechanism complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The lockout mechanism employs dynamic state transitions based on device usage. The mechanism automatically changes from a first state (permissive) to a second state (restrictive) through mechanical movement of components such as the slide element and insertion member, providing intelligent reuse prevention without complex control systems.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The lockout mechanism is self-actuating through the insertion and removal actions naturally performed during device use. The insertion member and slide element automatically transition states based on the physical act of inserting and removing the device from the multi-use device, eliminating the need for external control systems or additional user actions.

Inventive Principle:
Principle #25Self-service

3Reliability

If the slide element mechanically engages the housing in pre-use configuration, then device assembly reliability improves, but ease of operation deteriorates due to restricted insertion

Engineering Contradiction:
Improveassembly reliabilityVSAvoidinsertion ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The slide element dynamically transitions between engaged and disengaged states. During initial insertion, the mechanism is in a first state allowing free movement. After use and removal, it transitions to a second state where the slide element mechanically engages the housing, preventing reinsertion. This dynamic behavior resolves the contradiction between assembly reliability and insertion ease.

Inventive Principle:
Principle #15Dynamics

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

Effectively prevents single-use medical devices from being reused, ensuring patient safety by ensuring devices are used only once and maintaining equipment functionality by preventing wear and tear-related failures.

Implementation Method 1

the biasing mechanism is configured to exert a force on the slide element

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS20230042236A1Lockout mechanism for single use device
Publication Date: 2023.02.09 BOSTON SCIENTIFIC SCIMED INC
  • US20230042236A1 patent drawing
  • US20230042236A1 patent drawing
  • US20230042236A1 patent drawing

AI summary

Single use medical devices and mechanisms for preventing the re-use thereof. A single use medical device may include a housing defining an insertion slot and a lockout mechanism. The lockout mechanism may comprise a biasing mechanism and a movable slide element positioned adjacent to the insertion slot and the biasing mechanism, the slide element movable between a pre-use configuration, an in-use configuration, and a post-use configuration. The slide element may be actuated via an insertion member removably inserted into the insertion slot.