Mass Flow Measurement for Occluding Particle Detection in Microlumens
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Solution Overview
Problem
Current methods lack effective means to identify and quantify occluding particles within the lumens of medical devices, particularly those smaller than clinically relevant sizes, posing a risk of embolic complications during procedures.
Innovation Solution
A method involving mass flow measurements is developed to determine acceptance criteria for occluding particles, where a device is inspected by comparing its mass flow rate to criteria established using a representative device occluded with defined particles, allowing detection of particles as small as 50 microns or less, and grading occlusions to ensure safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If mass flow measurement is used to detect occluding particles, then measurement precision for small particles is improved, but device complexity increases
Solution Approach 1:
The patent replaces complex mechanical particle detection systems with mass flow measurement. Instead of using mechanical sensors or visual inspection to detect particles, the system measures mass flow rate through the lumen and compares it to acceptance criteria, thereby detecting occluding particles through fluid dynamics principles
Solution Approach 2:
The patent introduces mass flow rate as an intermediary parameter to indirectly detect the presence of occluding particles. Rather than directly measuring particles, the system measures the effect of particles on mass flow rate and uses this intermediary measurement to infer particle presence and quantify occlusion levels
2Reliability
If acceptance criteria are established for particle occlusion, then reliability of device safety is improved, but manufacturing precision requirements increase
Solution Approach 1:
The patent establishes acceptance criteria for mass flow rate before devices are put into service. By pre-defining the upper test limit mass flow rate based on representative occluded devices, the system creates a safety threshold that manufacturers can use to ensure devices meet safety requirements before deployment
Solution Approach 2:
The patent transforms the safety assessment from direct particle counting to mass flow rate parameter measurement. By changing the measurement parameter from particle presence to mass flow rate, the system provides a quantitative safety metric that is easier to measure and enforce during manufacturing and testing
Data Source
AI summary
Method and systems for determining acceptance criteria for identification of occluding particles in a lumen of a device are provided. The methods and systems can be used in methods of identifying an occluded device in an inspection method.