Aortic Valve Isolation and Flushing for Stenosis Treatment
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Solution Overview
Problem
Aortic valve stenosis, characterized by calcification leading to reduced valve mobility and increased pressure, results in limited cardiac output and eventual heart failure, with current treatments like valve replacement carrying significant risks and disadvantages.
Innovation Solution
The use of devices and methods involving an aortic valve isolation element and a flushing element to locally administer an acidic dissolution fluid to the stenotic aortic valve, increasing valve flow by dissolving calcium deposits, while minimizing contact with non-valve tissue using a buffer fluid.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If aortic valve replacement surgery is performed, then valve function is restored, but surgical risks and mortality (about 5%) increase
Solution Approach 1:
The patent replaces mechanical surgical intervention with a chemical dissolution system. An acidic dissolution fluid is delivered through a catheter-based delivery system to chemically dissolve calcific deposits on the aortic valve, substituting the mechanical act of surgical valve replacement with a chemical process that preserves the native valve structure while restoring function
Solution Approach 2:
The patent introduces an acidic dissolution fluid as an intermediary substance between the treatment goal and the aortic valve. This fluid acts as a mediator that selectively dissolves calcium deposits without requiring direct mechanical contact or surgical intervention, thereby reducing surgical risks while achieving valve function restoration
2Reliability
If dissolution fluid is applied to aortic valve, then calcification is reduced and valve flow increases, but non-valve tissue may be damaged by the acidic fluid
Solution Approach 1:
The patent applies local quality by delivering the acidic dissolution fluid specifically to the aortic valve region through a targeted delivery system. The occlusion elements isolate the treatment zone, ensuring that the harsh acidic environment is confined only to areas requiring calcification removal, while surrounding healthy tissues are protected by maintaining a neutral or physiological environment outside the isolated zone
Solution Approach 2:
The patent segments the aortic root into distinct zones using occlusion elements that create isolated compartments. This segmentation allows the acidic dissolution fluid to be applied to specific segments (valve leaflets with calcification) while other segments (coronary ostia, non-target tissues) are protected by physical barriers, enabling selective treatment without collateral damage
3Reliability
If occlusion elements are deployed to isolate aortic valve, then dissolution fluid is contained, but coronary ostia may be blocked
Solution Approach 1:
The patent extracts or removes the coronary ostia from the isolation zone by positioning occlusion elements that define an isolation volume excluding the coronary openings. The distal occlusion element is positioned below the coronary ostia while the proximal occlusion element is positioned above them, effectively taking the coronary ostia out of the confined space where acidic fluid is present, thereby preventing blockage while maintaining fluid containment in the treatment zone
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
This approach effectively increases aortic valve flow, reduces calcification, and alleviates symptoms associated with aortic stenosis, potentially delaying the need for valve replacement and reducing the risks associated with surgical interventions.
Implementation Method 1
the isolated valve is flushed with a dissolution fluid, e.g., an acidic dissolution fluid, for a period of time sufficient for the aortic valve flow of the treated valve to be increased
Data Source
AI summary
Devices and methods for their use in increasing the aortic valve flow of a stenotic aortic valve are provided. The subject devices include an aortic valve isolation element and an aortic valve flushing element. The aortic valve isolation element is made up of a ventricular side aortic valve occlusion element, coronary ostia occlusion elements and an ascending aorta occlusion element. The aortic valve flushing element is made up of a dissolution fluid introducing element and a fluid removal element. In practicing the subject methods, a stenotic aortic valve is first isolated. Next, the isolated valve is flushed with a dissolution fluid, e.g., an acidic dissolution fluid, for a period of time sufficient for the aortic valve flow of the treated valve to be increased. In certain embodiments, the valve is also contacted with a dissolution fluid attenuating fluid, e.g., a buffer, during the flushing step in order to limit the contact of non-valve tissue with the dissolution fluid. Also provided are systems and kits that include the subject devices and can be employed in practicing the subject methods. The subject devices, methods, systems and kits find use in treating conditions associated with the presence of stenotic aortic valves.