Antegrade Valve Delivery Catheter With Chordae Deflection
Solution Overview
Problem
Antegrade transcatheter aortic valve replacement (TAVR) procedures are historically difficult due to challenges such as the need for an atrial septal crossing, potential damage to the mitral valve, and issues with delivering large-profile implantation devices through the left atrium, leading to their largely being supplanted by retrograde approaches despite their associated complications.
Innovation Solution
The use of an outer catheter and interchangeable inner catheters configured for monorail advancement, with steerable and bendable regions, along with an expandable deflector and rapid pacing sheath, to navigate the venous vasculature safely and avoid engagement with the chordae tendinae, allowing for antegrade delivery of heart valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If retrograde TAVR approach is used, then the pathway for catheter delivery is simpler, but major bleeding at arterial access site and stroke from embolic debris occur
Solution Approach 1:
The patent inverts the conventional retrograde approach by implementing an antegrade TAVR method where the catheter is advanced in the direction of blood flow from the left ventricle through the aortic valve, rather than opposing blood flow from the aorta. This inversion eliminates trauma to the aortic arch and reduces stroke risk, while using venous access instead of arterial access to reduce bleeding complications
2Object-affected harmful factors
If antegrade TAVR approach is used, then venous access reduces bleeding and aortic arch trauma is eliminated, but atrial septal crossing is required and mitral valve damage may occur
Solution Approach 1:
The patent introduces a deflector device as an intermediary component that is advanced through the mitral valve along with the catheter system. This deflector serves as a mediator to prevent the catheter and implantable valve from engaging with or damaging the mitral valve leaflets and chordae tendineae during the antegrade delivery process, thereby enabling safe passage through the left atrium and mitral valve
3Reliability
If large-profile implantation device is delivered through left atrium, then aortic valve replacement can be achieved, but delivery difficulties and potential damage to mitral valve increase
Solution Approach 1:
The patent segments the delivery system into multiple components: an outer catheter, an inner catheter, a guidewire, and a deflector device. This segmentation allows each component to perform its specific function - the guidewire provides tracking, the outer and inner catheters provide structural support and delivery pathways, and the deflector protects mitral valve structures. The segmented approach enables safe delivery of large-profile implantation devices through the left atrium without compromising ease of operation
Data Source
AI summary
Apparatuses, including systems, for performing a valve replacement or repair. Apparatuses may include an outer catheter, 2024/148366 one or more interchangeable inner catheters, a guidewire and an expandable chordae tendinae deflector. The outer catheter and inner catheter may be configured to engage with to prevent gaps. The inner catheter may include a chordae tendinae deflector. The outer catheter may be configured as a rapid pacing sheath that may be used with any of these apparatuses.WO