Sutureless Transcatheter Heart Valve Anchoring After Leaflet Excision
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Solution Overview
Problem
Existing transcatheter aortic valve implantation (TAVI) procedures face issues such as paravalvular regurgitation, premature structural deterioration, thrombotic clots, patient-prosthesis mismatch, and difficult access to coronary arteries due to the presence of native stenotic valves, which are invasive and risky for younger patients.
Innovation Solution
A sutureless transcatheter heart valve prosthesis with a collapsible stent structure featuring sub-annular, supra-annular, and sinusal anchoring elements that cinch the valve commissures and resection profile after native leaflet excision, providing a secure fit within the heart valve annulus, reducing complications like paravalvular regurgitation and ensuring optimal hemodynamic function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If TAVI is performed with native stenotic valve in place, then the procedure is minimally invasive, but paravalvular regurgitation and thrombotic clots occur due to blood stagnation in regions close to stent pillars
Solution Approach 1:
The native valve leaflets are excised before TAVI implantation to eliminate the source of paravalvular regurgitation and blood stagnation. This preliminary removal of the diseased valve creates a clean annular surface for the prosthetic valve to seal against, preventing future regurgitation and thrombus formation while maintaining the minimally invasive transcatheter approach
Solution Approach 2:
The calcified native valve leaflets are completely removed from the aortic annulus using specialized excision devices. This extraction eliminates the harmful interaction between the prosthetic valve and the diseased native tissue, removing the source of paravalvular leaks and blood stagnation zones that lead to thrombosis
2Object-affected harmful factors
If surgical aortic valve replacement is performed to remove native diseased valve, then paravalvular regurgitation is eliminated, but the procedure is highly invasive requiring open-heart access
Solution Approach 1:
A transcatheter excision device serves as an intermediary tool that enables complete removal of the native valve leaflets through minimal access. This intermediary device bridges the gap between the minimally invasive TAVI approach and the need for complete native valve removal, allowing surgical-grade valve excision without open-heart surgery
Solution Approach 2:
The traditional mechanical open-heart surgical approach is replaced with a transcatheter-based system that uses specialized excision devices to remove the native valve. This substitution maintains the therapeutic benefit of complete valve removal while eliminating the need for sternotomy and cardiopulmonary bypass
3Adaptability or versatility
If polymeric leaflets are used in TAVI, then bovine and porcine pericardium are replaced, but overly close coaptation limits blood wash-out and encourages thrombogenesis
Solution Approach 1:
The native valve leaflets are excised before implanting the polymeric leaflet TAVI. This preliminary removal creates adequate spacing and eliminates the problematic interaction between native calcified tissue and polymeric leaflets, ensuring proper blood flow patterns and wash-out that prevent thrombus formation while maintaining the benefits of polymeric material
Data Source
Figure 1a~1b
Figure 2
Figure 3
AI summary
Sutureless transcatheter heart valve prosthesis comprising a collapsible stent structure with anchoring elements and a valve component located within said stent structure; characterized by the fact that the stent structure is configured to be positioned within a heart valve annulus after full excision of the native valve leaflets (1); the said stent structure comprising a sub-annular anchoring element (13), a supra-annular anchoring element (12), and wherein said sub- and supra-annular anchoring elements (13,12)are configured to cinch ridges (9) that are formed by the valve commissures (2) and the resection profile (5) after the full excision of said native valve leaflets (1).