Transcatheter Leaflet Laceration Assembly for Coronary Flow Protection
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Solution Overview
Problem
Coronary artery obstruction is a common complication during transcatheter aortic valve replacement (TAVR) due to displacement of the underlying surgical or native aortic valve leaflets, which can obstruct blood flow to the coronary arteries, particularly in valve-in-valve TAVR procedures.
Innovation Solution
A transcatheter valve laceration device with an expandable and contractible cutting element mounted on a guiding structure, which includes a support structure to protect neighboring tissues and is designed to cut the leaflets to allow blood flow to the coronary arteries, suitable for procedures like tricuspidization of bicuspid or quadricuspid valves to prepare for safe TAVR.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the transcatheter heart valve displaces the underlying surgical or native aortic valve leaflets outward, then the valve replacement is achieved, but coronary artery obstruction occurs due to sealing the sinus of Valsalva or covering the coronary ostia
Solution Approach 1:
The device performs preliminary laceration of the aortic valve leaflets before valve deployment to create controlled openings that prevent leaflet displacement into the coronary arteries during subsequent valve implantation, thereby preventing coronary obstruction while enabling successful valve replacement
2Productivity
If the cutting element is expanded to cut the leaflets, then blood flow to coronary arteries is restored, but damage to neighboring tissues may occur
Solution Approach 1:
The device employs a support structure with protective elements positioned adjacent to the cutting element to provide localized protection to neighboring tissues while allowing the cutting element to access and lacerate the target leaflets, thereby restoring blood flow while minimizing collateral tissue damage
Solution Approach 2:
The support structure acts as an intermediary between the cutting element and surrounding tissues, shielding vulnerable areas from direct contact with the cutting element while still permitting the cutting action to effectively lacerate the valve leaflets for blood flow restoration
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 device effectively prevents coronary artery obstruction by ensuring blood flow to the coronary arteries during TAVR, while minimizing damage to surrounding tissues and facilitating safe implantation of prosthetic valves.
Implementation Method 1
The cutting element is expanded and moved (in a direction which may be different than the expansion direction) towards the valve leaflets to cut them
Implementation Method 2
A support structure may be provided on the opposite side of the valve leaflets to act as an 'anvil' against the cutting force of the cutting element and to protect tissues, which should not be cut, from the cutting element
Data Source
AI summary
A transcatheter valve laceration device (10, 100) includes a leaflet support frame (12, 112) and a leaflet cutting assembly (14, 114), both of which are movably mounted on a guiding structure (16, 116) and movable between contracted and expanded orientations. In the expanded orientation, a blade protector (24, 124) of the leaflet support frame (12, 112) is positioned over a cutting element (36, 136) of the leaflet cutting assembly (14, 114).