Medical Particulate Testing Device with Tortuous Pathway
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Solution Overview
Problem
Current medical device testing methods do not adequately simulate the conditions under which implantable devices shed particles during implantation or manipulation through human tissues, particularly in the vasculature, which is crucial for FDA approval.
Innovation Solution
A testing device that replicates the human body environment by using a closed-loop system with a test solution that mimics blood flow, temperature, and pH, and includes a tortuous pathway to simulate the vasculature, equipped with particle counters and a debubbler to accurately measure particle shedding from medical devices during implantation or manipulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional testing methods are used to determine particle shedding, then testing can be performed with simple equipment, but the testing conditions do not accurately replicate human body environment and implantation conditions
Solution Approach 1:
The patent creates a simplified copy of the human body environment by using a test solution with matched pH and temperature, a tortuous pathway to simulate vasculature, and a closed-loop system to replicate blood flow conditions. This allows accurate particle shedding measurement without requiring actual human tissue or complex biological systems.
Solution Approach 2:
The patent controls and maintains specific parameters (pH, temperature, flow rate) to match human body conditions. By adjusting and holding these parameters constant, the system replicates physiological conditions that affect particle shedding, thereby improving measurement accuracy without excessive complexity.
2Loss of time
If durability testing is accelerated by condensing lifetime heartbeat cycles into shorter periods, then testing time is reduced, but the testing may not capture particle shedding that occurs during actual implantation manipulation
Solution Approach 1:
The patent performs implantation manipulation testing before durability testing. By first subjecting the device to tortuous pathway navigation and implantation-like maneuvers in the simulated body environment, the system captures particle shedding that occurs during actual implantation procedures, complementing the accelerated durability data.
Solution Approach 2:
The patent separates the testing process into distinct phases: implantation manipulation testing (through tortuous pathway) and durability testing (accelerated heartbeat cycles). This segmentation allows each aspect of particle shedding to be evaluated under appropriate conditions, ensuring comprehensive and reliable data.
3Measurement precision
If a tortuous pathway is introduced to simulate vasculature, then implantation conditions are better replicated, but the device complexity and testing setup become more complicated
Solution Approach 1:
The patent uses a tortuous pathway with curves and bends to simulate the natural geometry of human vasculature. This curved path replication is essential for accurately capturing particle shedding during implantation, as it reproduces the mechanical stresses and rubbing conditions devices experience in actual vessels.
Solution Approach 2:
The patent employs a closed-loop hydraulic system to circulate test solution through the tortuous pathway, replicating blood flow conditions. This hydraulic approach provides controlled flow rates and pressure conditions that mimic physiological environments, improving measurement accuracy while maintaining manageable system complexity.
4Measurement precision
If particle counters are used to detect shed particles, then particle counting capability is enhanced, but bubbles in the test solution can interfere with accurate particle detection
Solution Approach 1:
The patent removes bubbles from the test solution before it reaches the particle counter by using a debubbler device. This extraction of the harmful element (bubbles) prevents interference with particle detection, ensuring accurate particle counting while maintaining the integrity of the closed-loop test system.
Solution Approach 2:
The debubbler acts as an intermediary component between the test solution circulation system and the particle counter. It mediates by filtering out bubbles from the solution, protecting the sensitive particle detection system from interference while allowing continuous operation of the closed-loop test.
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
Enables accurate determination of particle shedding from medical devices during simulated implantation, providing critical data for FDA review by replicating the conditions of implantation and manipulation, ensuring reliable and precise particle counting and analysis.
Implementation Method 1
The test solution is maintained at a pH, temperature, and consistency similar to that of human blood. The test solution is passed through the test pathway that should ideally replicate the length of the human vasculature or other tissue through which the device will be passed during the procedure.
Implementation Method 2
A testing device includes a debubbler that removes bubbles from a test solution.
Implementation Method 3
Five particle counters are provided that are adapted to count particles in the test solution.
Data Source
AI summary
An acute medical particulate testing device for determining particle shed from a medical device during implantation. The device includes a closed loop system through which a solution is forcibly passed. An inlet port allows a catheter-mounted medical device to be incorporated into the flow loop. At least one tortuous passage is provided to replicate the vascular pathway and tortuosity which simulates the turns and bends and rubbing that affect particulate release from an implantable medical device as it is passed through the vasculature. A debubbler is provided to remove air bubbles from the solution before it is passed into a particle counting device that counts particle shed from the medical device during the simulated implantation. A filter having desired porosity removes particles from the solution. A final filter system removes all particles and air bubbles from the solution before it is re-circulated through the loop.