Bendable Leaflet Cutting Tool for Coronary Ostial Clearance
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Solution Overview
Problem
Existing methods for modifying valvular structures, such as lacerating leaflets, require high spatial precision and surgical skill, and can lead to poor heart valve function, aortic insufficiency, and risk of debris release, especially when dealing with calcified leaflets or prosthetic valves that displace native leaflets into the left ventricular outflow tract.
Innovation Solution
A tissue cutting tool with a bendable section and blades that can be transitioned between unbent and bent configurations, allowing precise cutting or modification of valvular leaflets to create openings for prosthetic valve implantation, reducing the risk of coronary ostial obstruction and improving procedural safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If lacerating or severing a portion of one or more leaflets of the host valve is performed to mitigate coronary ostial obstruction, then the risk of blocking coronary ostia is reduced, but the existing heart valve function deteriorates and the risk of aortic insufficiency increases
Solution Approach 1:
The host valve leaflet is divided into two parts: a preserved portion that maintains valve function and a removed portion that prevents coronary ostial obstruction. The cutting tool creates a specific cut pattern that segments the leaflet to achieve both goals simultaneously.
Solution Approach 2:
The cutting tool applies different treatments to different regions of the leaflet: precise cutting in the region that would obstruct coronary ostia while preserving the functional region. This localized approach maintains valve reliability while eliminating the harmful obstruction risk.
2Object-affected harmful factors
If high spatial precision and surgical skill are used to lacerate leaflets, then coronary ostial obstruction is mitigated, but the complexity and difficulty of the procedure increases
Solution Approach 1:
A specialized cutting tool acts as an intermediary device between the surgeon and the leaflet tissue. The tool incorporates guide features, positioning mechanisms, and controlled cutting elements that reduce the skill and precision requirements compared to manual laceration techniques.
Solution Approach 2:
The cutting tool is pre-positioned and pre-configured before contact with the leaflet, with guide structures that automatically align the cutting path. This preliminary positioning reduces the need for high surgical skill during the actual cutting process.
3Object-affected harmful factors
If lacerating is performed on calcified leaflets, then coronary ostial obstruction is prevented, but particulate debris is released into the bloodstream causing vascular occlusion or stroke risk
Solution Approach 1:
The cutting mechanism is replaced or supplemented with a controlled mechanical system that minimizes debris generation. The tool uses controlled cutting forces and includes debris management features to prevent particulate release into the bloodstream.
Solution Approach 2:
The calcified portions of the leaflet that would otherwise be problematic are systematically removed through controlled cutting, converting the potential harm of calcification (obstruction risk) into a benefit (debris-free removal). The controlled process prevents the calcified material from breaking into harmful particles.
4Reliability
If prosthetic valve is expanded against native annulus and leaflets, then valve replacement is achieved, but the anterior leaflet is pushed into the left ventricular outflow tract limiting outflow
Solution Approach 1:
The leaflet is pre-cut and repositioned before prosthetic valve expansion. This preliminary modification creates space and prevents the anterior leaflet from being pushed into the outflow tract during valve deployment, avoiding obstruction while maintaining successful replacement.
Solution Approach 2:
The leaflet is segmented to separate the anterior portion that would obstruct outflow from the functional portions needed for valve operation. This segmentation allows the obstructing portion to be repositioned or removed while preserving valve function.
Data Source
AI summary
The present disclosure relates to tissue cutting tools that can be used for forming an opening in a target tissue, such as a host leaflet within which a guest prosthetic valve can be expanded. In an example, the tissue cutting tool comprises an actuation tube and a blade support tube extending therethrough. A distal portion of the blade support tube can be coupled to a distal portion of the actuation tube, and a proximal portion of the blade support tube can be axially movable with respect to a proximal portion of the actuation tube. The blade support tube also includes a bendable section extending between its distal and proximal portions, and configured to transition between unbent and bent configuration thereof. At least one blade is coupled to at least one arm of the bendable section.