Heart Valve Leaflet Cutting for Transcatheter Implant Clearance
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Solution Overview
Problem
Transcatheter therapies for valvular heart disease face challenges due to interference from native or prosthetic leaflets, leading to complications such as LVOT obstruction in mitral valve replacement and coronary flow impairment in aortic valve replacement, which can result in severe health issues.
Innovation Solution
A steerable delivery catheter system with a leaflet crossing tool and cutting element is used to precisely modify and remove native or prosthetic valve leaflets, minimizing interference by creating space for prosthetic implants and reducing the risk of complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transcatheter valve replacement is performed with native or prosthetic leaflets left intact, then the procedure can be performed with minimal invasive approach, but the leaflets may interfere with valve implantation and cause complications such as LVOT obstruction or coronary flow impairment
Solution Approach 1:
The patent applies preliminary action by modifying or removing the native or prosthetic valve leaflets before implanting the prosthetic valve. This preparatory step eliminates the interference that would otherwise occur between the existing leaflets and the new prosthetic valve, preventing complications such as LVOT obstruction or coronary flow impairment while maintaining the minimally invasive transcatheter approach
2Reliability
If native or prosthetic valve leaflets are modified or removed to prevent interference, then safety of subsequent valve implantation is improved, but the procedure complexity increases due to the need for additional modification steps
Solution Approach 1:
The patent applies universality by designing a multi-functional delivery system that can perform both the valve implantation and the leaflet modification functions. The delivery catheter system is configured to accommodate cutting elements and other modification tools, allowing a single device to serve multiple purposes: modifying existing leaflets, removing obstructive tissue, and implanting the prosthetic valve, thereby reducing overall procedure complexity
3Area of stationary object
If leaflet modification is performed to create space for prosthesis, then effective orifice area is increased, but the risk of damaging healthy tissue or creating anatomical defects increases
Solution Approach 1:
The patent applies local quality by using targeted cutting elements that can be precisely positioned to modify only specific portions of the valve leaflets. The cutting elements are designed to remove only the problematic tissue (such as calcified or obstructive portions) while preserving the healthy, functional portions of the leaflets and surrounding anatomy, thereby increasing the effective orifice area without causing unnecessary damage to healthy tissue
Data Source
AI summary
A system and method modifying a heart valve leaflet utilizing a leaflet crossing tool and a cutting element.