Bench-Top Model for Implantable Medical Device Testing
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Solution Overview
Problem
Current methods for evaluating implantable medical devices, such as stents, in dynamic environments are costly, limited in sample size, and difficult to compare due to individual anatomical differences, and lack the ability to consistently apply physiological forces without invasive procedures.
Innovation Solution
A system comprising a support structure and simulated tissue that simulates physiological forces, allowing for the deployment and testing of implantable medical devices in a controlled environment, including skeletal and muscular supports, to apply dynamic forces similar to those experienced in the human body, enabling consistent evaluation of various devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If in vivo and cadaveric studies are used to evaluate medical device performance, then realistic physiological data can be obtained, but the cost increases and sample size is limited
Solution Approach 1:
The patent creates a bench-top model that copies the essential biomechanical characteristics of the human leg (skeletal structure, soft tissue, arterial system) to simulate physiological forces on stents. This allows numerous samples to be tested in a controlled environment without using actual human subjects or cadavers, thereby increasing sample size while maintaining realistic physiological data through accurate force simulation.
2Reliability
If in vivo studies are conducted to compare different medical devices, then performance comparison can be made, but the procedure becomes intrusive and harmful to patients
Solution Approach 1:
The patent introduces a bench-top model as an intermediary system between device testing and patient evaluation. This model allows multiple devices to be tested under identical simulated physiological conditions without introducing any devices into patients. The model acts as a mediator that provides comparable performance data while eliminating the harmful effects of invasive procedures.
3Reliability
If clinical and cadaveric studies are used for device evaluation, then in vivo performance information can be obtained, but the procedure becomes time consuming and expensive
Solution Approach 1:
The patent replaces the complex biological mechanical system of the human body with a simplified bench-top model that uses mechanical components (skeletal structure, soft tissue simulation, arterial system) to reproduce the essential biomechanical forces. This substitution allows rapid, repeated testing of devices under controlled conditions without the time-consuming procedures required for clinical or cadaveric studies.
4Reliability
If multiple medical devices are tested in the same patient, then relative performance can be evaluated, but individual anatomical differences make comparison difficult
Solution Approach 1:
The patent creates a universal bench-top model that can test multiple different stent devices under identical simulated physiological conditions. The model's standardized skeletal structure, soft tissue, and arterial system provide consistent anatomical representation for all device tests, eliminating the variability introduced by individual patient anatomical differences while maintaining the ability to evaluate relative device performance.
Data Source
AI summary
Systems, apparatuses, and methods for evaluating medical device performance are provided. A corresponding method may include deploying an implantable medical device into an apparatus for evaluating performance of an implantable medical device. The apparatus may include a support structure and simulated tissue operatively associated with the support structure. The method may further include manipulating the support structure and/or the simulated tissue to simulate physiological forces on the implantable device.