Sinus-Matched Aortic Valve Leaflets for Anatomical Accuracy
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Solution Overview
Problem
Current heart valve prostheses often fail to accurately replicate the anatomical geometry of the aortic root, leading to suboptimal function and hemodynamics, particularly in cases of congenital malformations like bicuspid aortic valve, which can result in stenosis and insufficiency, compromising blood flow and increasing mechanical stress on the heart.
Innovation Solution
The method involves generating aortic heart valve leaflets using three-dimensional anatomical imaging data to create sinus-matched leaflets that conform to the patient's specific aortic root morphology, including the use of truncated sinus surfaces and calculated planes to define leaflet surfaces, allowing for personalized prostheses with improved coaptation areas and blood flow profiles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional circular frame designs are used, then manufacturing simplicity is maintained, but anatomical matching accuracy deteriorates
Solution Approach 1:
The patent applies asymmetry by transitioning from conventional circular frame designs to asymmetric, non-circular frame geometries that match the patient-specific aortic root sinus morphology. The frame is customized based on 3D imaging data to reflect the unique asymmetric shape of each patient's aortic root, improving anatomical matching accuracy while accepting increased design complexity.
2Reliability
If standardized leaflet geometries are used, then manufacturing ease is maintained, but functional performance deteriorates
Solution Approach 1:
The patent applies local quality by creating patient-specific leaflet geometries that are customized to match the individual's aortic root sinus morphology. Each leaflet is designed with unique curvature, size, and shape characteristics derived from 3D imaging data, ensuring optimal functional performance and hemodynamics for that specific patient rather than using standardized geometries.
3Productivity
If patient-specific sinus morphology is ignored, then device simplicity is maintained, but blood flow hemodynamics deteriorate
Solution Approach 1:
The patent applies preliminary action by performing 3D imaging and sinus morphology analysis before valve implantation. The patient-specific frame and leaflet geometries are pre-customized based on pre-operative imaging data, allowing the valve to be tailored to the patient's unique anatomy before the procedure, thereby optimizing blood flow hemodynamics while managing complexity through advance planning.
Data Source
AI summary
Methods for generating aortic heart valve leaflets are disclosed wherein the aortic sinus surfaces (the inner surfaces of the sinuses of Valsalva) are used as a template to generate geometric representations of replacement aortic heart valve leaflets. As such, sinus-matched replacement leaflets can be sized and shaped according to the patient-specific geometry of the aortic root. Patient-specific aortic valve assemblies based on aortic root and sinus geometry are also described. Methods for estimating the coaptation area of a sinus-matched valve and assessing whether the valve is functionally competent for implantation are described.