Transcatheter Heart Valve Markers for Radiographic Alignment
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Solution Overview
Problem
Minimally invasive transcatheter heart valve prosthesis implantation procedures face challenges due to the lack of line-of-sight visualization, making proper axial and rotational orientation of the prosthesis difficult, which can lead to improper placement and potential blockage of native structures like coronary arteries.
Innovation Solution
A transcatheter heart valve prosthesis with integrated markers, including inflow and outflow markers, that are visible on radiographic images, allowing for accurate axial and rotational alignment within the native heart valve location, facilitating correct placement and avoiding coronary artery obstruction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If minimally invasive transcatheter heart valve prosthesis implantation is used, then patient trauma and recovery time are reduced, but line-of-sight visualization of the prosthesis is lost making proper alignment difficult
Solution Approach 1:
The patent incorporates radiopaque markers with distinct visual characteristics that appear differently on fluoroscopic images at various orientations. These markers change their visible position and appearance based on the rotational orientation of the prosthesis, enabling the physician to detect and measure the alignment status without requiring direct line-of-sight visualization.
Solution Approach 2:
The patent introduces radiopaque markers as intermediary elements that mediate between the prosthesis structure and the imaging system. These markers serve as visible proxies for the prosthesis orientation, allowing the physician to infer alignment information from the markers' positions on fluoroscopic images rather than directly visualizing the prosthesis itself.
2Difficulty of detecting and measuring
If radiographic imaging is used for positioning, then the prosthesis can be visualized, but the physician must interpret complex 2D images requiring skill and time
Solution Approach 1:
The radiopaque markers are designed to produce distinct, easily distinguishable images on fluoroscopic screens. By using markers with specific radiopaque properties that create high-contrast visual signals, the system transforms complex 2D image interpretation into simpler visual recognition of marker positions and orientations, reducing the time and skill required for accurate positioning.
3Productivity
If proper alignment is not achieved, then the procedure can be completed, but migration and blockage of native structures may occur
Solution Approach 1:
The patent implements a real-time feedback mechanism where the positions of radiopaque markers are continuously monitored on fluoroscopic images during the implantation procedure. This visual feedback allows the physician to adjust the prosthesis orientation dynamically to achieve proper alignment, ensuring both procedure completion and placement accuracy by confirming correct positioning before final deployment.
Data Source
AI summary
A transcatheter valve prosthesis includes a stent having a radially compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The stent includes an inflow portion, an outflow portion, and at least one commissure post extending between the inflow portion and the outflow portion. Inflow and/or outflow markers are positioned on the stent to enable longitudinal and rotational orientation of the stent during the installation at the implant location.