Prosthetic Valve Fluoroscopic Markers for Precise Aortic Placement
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Solution Overview
Problem
Current prosthetic valve implantation techniques, particularly for aortic stenosis, face challenges in achieving precise placement and minimizing protrusion and obstruction risks, which can lead to complications such as cardiac conduction disturbances and coronary artery obstruction during less invasive catheterization procedures.
Innovation Solution
A balloon expandable prosthetic valve with a flexible support frame featuring alternating light and dark bands under fluoroscopy, allowing for precise orthotopic positioning using the aortic annular plane as a reference, and an annular skirt made from fabric attached to the support frame, ensuring optimal deployment and minimizing protrusion into the left ventricle and coronary ostia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a prosthetic valve is implanted by percutaneous catheterization technique, then the invasiveness of the procedure is reduced, but the precision of valve placement and control over protrusion becomes more difficult
Solution Approach 1:
The support frame incorporates radiopaque markers that appear as alternating light and dark bands under fluoroscopy, enabling visual detection and precise positioning of the valve during catheterization implantation without requiring more invasive surgical exposure
2Ease of operation
If the support frame struts are made thinner for easier maneuverability, then the ease of operation improves, but the mechanical strength of the valve structure decreases
Solution Approach 1:
The support frame is divided into multiple modular segments including distal support elements, proximal support elements, and intermediate connection elements. This segmentation allows each component to be optimized independently - thinner struts for maneuverability in critical sections and reinforced structures where mechanical strength is required for structural integrity
Solution Approach 2:
The support frame employs a balloon-expandable mechanism that transitions from a compressed delivery state to an expanded functional state. During delivery, the frame maintains a compact profile for easy maneuverability through catheters; upon balloon inflation, it expands to provide adequate mechanical strength and radial support at the implantation site
3Reliability
If the valve is positioned deeper to ensure secure implantation, then the reliability of fixation improves, but the risk of protrusion into the left ventricle and obstruction of coronary ostia increases
Solution Approach 1:
The support frame features non-uniform distribution of support elements with different densities and configurations at various locations. The distal support elements and proximal support elements are specifically designed with optimized geometry and spacing to provide enhanced anchoring in the aortic annulus while maintaining clear separation from the left ventricular outflow tract and coronary ostia, achieving secure fixation without excessive protrusion
Solution Approach 2:
The radiopaque markers arranged as alternating light and dark bands provide real-time visual feedback during fluoroscopic guidance, allowing the operator to precisely control the depth and position of valve implantation. This feedback mechanism enables accurate placement that achieves reliable fixation while avoiding over-implantation that could cause protrusion or coronary obstruction
Data Source
AI summary
A prosthetic valve has fluoroscopic properties for precise placement of the prosthetic valve in a human stenosed aortic orifice. The prosthetic valve comprises a support frame having a distal and a proximal end, and three adjacently placed rows of hexagonal cells (namely an upper, middle and a lower row). The upper row occupies 50-55% of total length of the support frame. The support frame of the prosthetic valve under fluoroscopy comprises a plurality of light bands and dark bands alternating with each other along the length of the support frame. Further, a second dark band from the distal end of the support frame is bisected by aortic annular plane on placement in orthotopic position of a human stenosed aortic orifice. The prosthetic valve offers advantages such as minimal protrusion in left ventricle and minimal obstruction of prosthetic valve to ostia of coronary arteries.