Segmented Balloon Reshaping Calcified Bicuspid Aortic Valve
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Solution Overview
Problem
Current methods for treating aortic stenosis with bicuspid aortic valves and severe calcification face challenges such as poor compliance of calcified leaflets, excessive displacement of TAVR valves, and hemodynamic disturbances during TAVR procedures.
Innovation Solution
A method involving a balloon with an expandable distal end is used to reshape the aortic valve by expanding the distal end to push the leaflets upward, creating a compliant space for a self-expandable TAVR valve, thereby improving valve compliance and reducing procedural risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If a cylindrical balloon is used to reshape the aortic valve, then the valve can be reshaped, but the risk of rupture of the valve annulus increases
Solution Approach 1:
The balloon is divided into a proximal portion and a distal portion with different expansion characteristics. The distal portion expands to reshape the valve leaflets while the proximal portion provides support without causing annular rupture, effectively segmenting the reshaping function from the support function.
Solution Approach 2:
Different portions of the balloon have different expansion properties. The distal portion is designed to expand more significantly to contact and reshape the calcified leaflets, while the proximal portion expands less to provide stable support, creating local quality differences that address specific needs at different locations.
2Reliability
If a smaller size balloon is used to reduce the risk of rupture, then the safety is improved, but the expansion becomes insufficient
Solution Approach 1:
The balloon is segmented into functional zones: the distal portion provides strong expansion force for reshaping calcified leaflets, while the proximal portion provides stable support. This segmentation allows the balloon to achieve both sufficient expansion and safety simultaneously.
Solution Approach 2:
The balloon exhibits local quality differences where the distal portion has higher expandability to address severe calcification, while the proximal portion has lower expandability to ensure safety. This localized property distribution resolves the contradiction between expansion sufficiency and safety.
3Productivity
If rapid ventricular pacing is used during balloon expansion, then the expansion can be achieved, but hemodynamic disturbance occurs in patients with poor left ventricular function
Solution Approach 1:
The balloon expansion process is segmented into controlled phases with the distal portion expanding first to reshape the valve, followed by controlled proximal expansion. This staged approach eliminates the need for rapid ventricular pacing while achieving complete valve reshaping.
Solution Approach 2:
The distal portion of the balloon is expanded preliminarily to reshape the valve leaflets before the proximal portion is fully expanded. This preliminary action allows the valve to be reshaped without requiring rapid ventricular pacing, thereby avoiding hemodynamic disturbance.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method effectively reshapes the aortic valve, improving compliance and facilitating successful TAVR procedures by reducing perivalvular leakage and the need for additional interventions, while minimizing hemodynamic disturbances.
Implementation Method 1
expanding the balloon so that the distal end of the balloon is expanded to push the leaflets upward from bottom of the aortic valve to reshape the leaflets
Implementation Method 2
push the leaflets upward from bottom of the aortic valve to reshape the leaflets, and form a space compliant to a self-expandable interventional valve for release
Data Source
AI summary
A method of reshaping a severely stenosed aortic valve having leaflets with bicuspid malformation and severe calcification. The method includes delivering a balloon with an expandable distal end to the aortic valve, expanding the balloon so that the distal end of the balloon is expanded to push the leaflets upward from bottom of the aortic valve to reshape the leaflets, and forming a space compliant to a self-expandable interventional valve for release, thereby facilitating the following TAVR procedure, reducing the adverse consequences of the TAVR procedure, and improving the surgical stability and the surgical prognosis.