Calcified Annulus Model for TAVR Device Anchoring
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Solution Overview
Problem
Current large animal models lack a stenotic or calcified aortic annulus, making it challenging to evaluate transcatheter aortic valve replacement (TAVR) devices effectively, as they cannot mimic human pathology, leading to issues like device migration and catastrophic failure.
Innovation Solution
A calcified annulus model is created by implanting a ring structure with a silicone core covered in Dacron fabric, which simulates a stenotic aortic annulus, allowing for proper anchoring and deployment of TAVR devices in large animal models, similar to human patients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a TAVR device is deployed in a healthy large animal model without calcified annulus, then the deployment procedure can be performed, but the device is prone to migration and catastrophic failure due to lack of anchoring resistance
Solution Approach 1:
The patent applies preliminary action by pre-implanting a calcific annulus model in the large animal before TAVR device deployment. This pre-created calcified structure provides the necessary anchoring resistance before the TAVR procedure, enabling proper device fixation and preventing migration while maintaining clinical relevance of the evaluation model
2Reliability
If a calcified annulus model is created in large animal, then TAVR device anchoring and deployment can be properly evaluated, but the model complexity and surgical procedure difficulty increase
Solution Approach 1:
The patent applies parameter changes by modifying the physical properties of the aortic annulus through controlled calcification. By changing the calcification degree and distribution parameters in the annulus model, the patent creates a clinically-relevant structure that provides appropriate anchoring resistance without excessive structural complexity
Data Source
AI summary
A device includes an annular, elastic band having a rectangular cross section. A foil band is affixed to a surface of the elastic band. A contiguous fabric sheath is configured to encase the elastic band and foil band.