Percutaneous Heart Valve Delivery System with Integrated Imaging
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Solution Overview
Problem
Current transcatheter aortic valve replacement (TAVR) procedures face challenges in accurately positioning and repositioning heart valves due to limitations in existing imaging technologies, leading to potential complications such as myocardial infarction, ischemia, and paravalvular regurgitation, as X-Ray provides only a 2D projection of 3D anatomy, making precise valve placement difficult.
Innovation Solution
A delivery system with adjustable arms or draw lines for controlled deployment and repositioning of heart valves, incorporating imaging modalities like IVUS for real-time visualization, allowing for precise placement and retrieval of heart valves without ionizing radiation, and utilizing biocompatible materials like NiTi alloy and PEEK for the valve frame.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If X-Ray imaging is used for image guidance during TAVR procedure, then real-time visualization during the procedure is achieved, but only 2D projection of 3D anatomy is provided making precise valve placement difficult
Solution Approach 1:
The patent combines multiple imaging modalities (X-Ray fluoroscopy, IVUS, and other imaging systems) into an integrated image guidance system that correlates images from different sources to provide both real-time visualization and precise 3D anatomical information for accurate valve placement
Solution Approach 2:
The image guidance system is designed to perform multiple functions: providing real-time 2D fluoroscopic guidance, integrating 3D anatomical information from other imaging modalities, and enabling precise valve placement through correlated multi-modal imaging
2Productivity
If instant deployment of the valve is used, then deployment speed is improved, but repositioning and retrieval become impossible or difficult
Solution Approach 1:
The patent employs a stepwise deployment mechanism that allows the valve to be deployed in controlled increments rather than instantly, enabling the valve to be repositioned both circumferentially and in the axial direction towards the left ventricle or ascending aorta before final deployment is complete
3Manufacturing precision
If the valve is placed too high in the aorta, then deployment position is achieved, but coronary ostia obstruction and embolization risk increase
Solution Approach 1:
The patent utilizes integrated image guidance systems that provide real-time feedback during the implantation process, allowing the operator to visualize the valve position relative to coronary ostia and make adjustments before final deployment to prevent obstruction
4Manufacturing precision
If the valve is placed too low in the aorta, then deployment position is achieved, but AV node compression and conduction abnormalities occur
Solution Approach 1:
The integrated image guidance system provides real-time feedback during implantation, allowing visualization of the valve position relative to the AV node and enabling adjustments to prevent compression and conduction abnormalities
5Measurement precision
If other imaging modalities (CT, MRI, ultrasound) are used prior to procedure, then anatomical visualization is improved, but correlation with intra-procedural X-Ray images is difficult
Solution Approach 1:
The patent integrates multiple imaging modalities into a single correlated image guidance system that combines pre-procedural imaging data with intra-procedural fluoroscopy, allowing direct correlation between different imaging types through a unified display and navigation interface
Data Source
Figure 1A~1F
Figure 2A~4B
Figure 5A~5E
AI summary
Embodiments described herein address the need for improved catheter devices for delivery, repositioning and/or percutaneous retrieval of the percutaneously implanted heart valves. One embodiment employs a plurality of spring-loaded arms releasably engaged with a stent frame for controlling expansion for valve deployment. Another embodiment employs a plurality of filaments passing through a distal end of a pusher sleeve and apertures in a self-expandable stent frame to control its state of deployment. With additional features, lateral positioning of the stent frame may also be controlled. Yet another embodiment includes plurality of outwardly biased arms held to complimentary stent frame features by overlying sheath segments. Still another embodiment integrates a visualization system in the subject delivery system. Variations on hardware and methods associated with the use of these embodiments are contemplated in addition to those shown and described.