Bicuspid Valve Dissection Device for Minimally Invasive Repair
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Solution Overview
Problem
Current methods for heart valve repairs and replacements face challenges in accurately cutting valve leaflets, especially when dealing with tough tissue or calcified deposits, which can lead to difficulties in advancing cutting elements and potential damage to surrounding tissue.
Innovation Solution
The development of devices and methods that utilize a steerable catheter with a cutting element and a foot element to precisely bisect valve leaflets, minimizing damage to surrounding tissue and allowing for percutaneous or minimally invasive procedures without the need for extracorporeal circulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional open-heart surgery with manual scalpel cutting is used, then valve leaflets can be cut, but the procedure requires extracorporeal circulation and causes significant trauma to surrounding tissue
Solution Approach 1:
The patent replaces the traditional mechanical scalpel cutting system with a catheter-based cutting element delivery system. The cutting element is advanced through the catheter to the valve leaflet and activated to bisect the leaflet, eliminating the need for open-heart surgery and extracorporeal circulation while maintaining cutting capability through the use of specialized cutting elements designed to penetrate tough or calcified tissue
Solution Approach 2:
The catheter serves as an intermediary delivery mechanism that allows the cutting element to reach the valve leaflet through minimally invasive access. The catheter guides and positions the cutting element precisely at the target location, enabling percutaneous or minimally invasive procedures while protecting surrounding tissue from direct surgical intervention
2Manufacturing precision
If cutting elements are advanced through tough or calcified valve tissue, then leaflet bisection can be achieved, but the cutting element may fail to advance or damage surrounding tissue
Solution Approach 1:
The cutting element is designed with localized cutting characteristics concentrated at its tip or leading edge, allowing it to penetrate tough or calcified valve tissue effectively. The cutting action is focused precisely at the intended bisection location, minimizing energy dispersion and reducing the risk of damage to surrounding tissue while achieving accurate leaflet separation
Solution Approach 2:
The catheter system incorporates features that protect surrounding tissue before and during the cutting process. The catheter shaft and delivery mechanism are designed to shield non-target structures, and the cutting element is contained within the catheter until precise positioning is achieved, preventing premature or unintended tissue damage
Data Source
AI summary
The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.