Temporary Aortic Valve Balloon for Hemodynamic Control
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Solution Overview
Problem
Current percutaneous aortic valve replacement procedures face challenges in precise placement and deployment due to the aortic valve's proximity to critical structures, leading to complications such as coronary or mitral valve dysfunction, and hemodynamic forces that hinder stable patient conditions during the procedure.
Innovation Solution
A novel temporary aortic valve with inflatable balloons is introduced to create a stable environment for precise placement and deployment of the percutaneous aortic valve, ensuring continuous coronary perfusion and minimizing hemodynamic stresses by pre-dilating and ablating the native valve, allowing for the use of a multi-balloon configured temporary aortic valve to facilitate the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If percutaneous aortic valve replacement is performed without a temporary valve, then the procedure is simpler, but patient stability deteriorates due to uncontrolled hemodynamic forces and coronary perfusion issues
Solution Approach 1:
A temporary aortic valve is implanted before the permanent PAV to pre-establish hemodynamic control and coronary perfusion. This preliminary action stabilizes the patient's condition and creates favorable hemodynamic conditions for the subsequent PAV deployment, preventing hemodynamic collapse during the procedure.
Solution Approach 2:
The temporary aortic valve acts as an intermediary device between the native valve and the permanent PAV. It mediates the hemodynamic transition by providing controlled valve function during the procedure, allowing the surgeon to work in a stabilized environment while protecting coronary perfusion and reducing hemodynamic stress on the heart.
2Stability of the object's composition
If the native aortic valve is not pre-dilated and ablated, then the anatomy remains intact, but precise PAV placement is hindered by the native valve structures
Solution Approach 1:
The native aortic valve is pre-dilated and ablated before PAV implantation to remove anatomical obstacles. This preliminary preparation creates a clear deployment path and stabilizes the aortic annulus geometry, enabling precise PAV placement while preventing complications from native valve interference.
Solution Approach 2:
The native aortic valve structures are selectively removed through ablation to eliminate interfering elements. This extraction of obstructive native valve tissue clears the deployment path for the PAV and removes structures that could compromise precise placement or cause complications during the procedure.
3Reliability
If hemodynamic forces are not minimized during the procedure, then the natural physiological conditions are maintained, but device embolization risk increases due to significant forces in the left ventricular outflow tract
Solution Approach 1:
The temporary aortic valve serves as a mediator that reduces hemodynamic forces acting on the PAV during deployment. By providing controlled valve function upstream, it dampens the significant hemodynamic forces in the left ventricular outflow tract, creating a more favorable environment for secure PAV placement and reducing embolization risk.
Solution Approach 2:
The temporary aortic valve provides beforehand cushioning by absorbing and moderating hemodynamic forces before they reach the PAV. This protective effect is established prior to PAV deployment, cushioning the device against the full force of ventricular contraction and reducing the risk of device displacement or embolization.
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 solution provides a stable physiologic and anatomic environment for PAV implantation, ensuring precise placement and reducing patient instability by maintaining coronary perfusion and alleviating transvalvular pressure gradients, thus enhancing the safety and success of the procedure.
Implementation Method 1
alleviating transvalvular pressure gradients
Data Source
AI summary
A catheter adapted for placement in the ascending aorta comprises a central catheter mechanism and a balloon structure or other occluding structure at its distal end. The catheter may be placed over the aortic arch such that the occluding structure is placed in the ascending aorta just above the Sinus of Valsalva and coronary ostia. Once in place, the occluding structure is inflated to control blood flow through the aorta during aortic valve ablation and replacement protocols.