Temporary Aortic Valve for Stable Percutaneous Replacement
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Solution Overview
Problem
Current percutaneous aortic valve replacement procedures face challenges in precise placement due to the proximity of vital structures and high hemodynamic forces, and are hindered by the large size of delivery systems, leading to vascular complications and instability.
Innovation Solution
A novel method employing a temporary aortic valve with inflatable balloons to create a stable environment for precise placement and deployment of aortic valve components, using pre-dilation and ablation to minimize the size of the delivery catheter and maintain patient stability through continuous coronary perfusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large size delivery system is used to deliver the aortic valve, then the valve can be delivered percutaneously, but vascular complications occur and the procedure becomes less safe
Solution Approach 1:
The delivery system is divided into multiple separate components including a catheter, balloon, and aortic valve assembly that are delivered sequentially through the vasculature. This segmentation allows each component to be smaller and less traumatic to vessels while still achieving the overall function of valve replacement
Solution Approach 2:
The aortic valve is nested within a compressed state inside the delivery catheter, which itself is passed through the vasculature. The valve is then expanded at the target site, allowing the large valve to be delivered through a small catheter without causing vascular complications
2Reliability
If precise placement of the aortic valve is attempted to avoid damaging adjacent structures, then valve function is preserved, but the procedure becomes more difficult due to high hemodynamic forces and anatomical constraints
Solution Approach 1:
A temporary valve is implanted before the permanent aortic valve to stabilize the anatomical structures and create a more favorable environment for subsequent valve placement. This preliminary action reduces the difficulty of precise placement by preventing structure movement during the procedure
Solution Approach 2:
The temporary valve acts as an intermediary device that facilitates the placement of the permanent valve by stabilizing the aortic annulus and adjacent structures. It serves as a mediator between the high hemodynamic forces and the precise placement requirements
3Ease of operation
If the native aortic valve is ablated to facilitate valve delivery, then delivery is improved, but patient stability is compromised due to loss of coronary perfusion
Solution Approach 1:
The temporary valve is implanted before ablation of the native valve to establish coronary perfusion pathways in advance. This preliminary action ensures that when the native valve is ablated, coronary blood flow is maintained through the temporary valve structure
Solution Approach 2:
The temporary valve provides a cushioning effect by maintaining coronary perfusion pressure before and during native valve ablation. This prior cushioning prevents hemodynamic instability that would otherwise occur when the native valve is destroyed
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 allows for precise and safe placement of percutaneous aortic valves with reduced vascular risk, enabling a more stable and controlled procedure by moderating hemodynamic forces and reducing the size of the delivery catheter, potentially making the procedure a routine, catheter-based mainstay therapy.
Implementation Method 1
The temporary aortic valve with inflatable balloons creates a stable environment for precise placement and deployment of aortic valve components by moderating hemodynamic forces
Implementation Method 2
using pre-dilation and ablation to minimize the size of the delivery catheter
Data Source
AI summary
A delivery system and method for percutaneous aortic valve (PAV) replacement and apparatus used therein. A temporary aortic valve including a reversibly expandable occluder surrounds a central catheter mechanism. The temporary valve is positioned within the ascending aorta, just above and downstream from the coronary ostia. The occluder is configured such that, when fully expanded against the aortic wall, gaps are left that promote continuous coronary perfusion during the cardiac cycle. The temporary valve substitutes for the function of the native aortic valve during its replacement. The native aortic valve is next dilated, and then ablated through deployment of low profile, elongated, sequentially delivered stents. The stent(s) displace the native tissues and remain within the aortic annulus to receive and provide a structure for retaining the PAV. The PAV is delivered, positioned and deployed within the stent(s) at the aortic annulus with precision and relative ease.