Aortic Leaflet Crossing With Selective Guidewire Control
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Solution Overview
Problem
Prosthetic heart valve delivery systems face challenges in crossing stenosed aortic leaflets due to difficulty in navigating guidewires and catheters, leading to increased procedure time and potential complications.
Innovation Solution
An aortic leaflet crossing system with a guide catheter and multiple guidewires, controlled by a control device, that allows for selective advancement and retraction of guidewires to consistently cross aortic leaflets, reducing the likelihood of guidewire entanglement and misalignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple guidewires are used to cross stenosed aortic leaflets, then the reliability of crossing the leaflets is improved, but the device complexity increases
Solution Approach 1:
The system divides the guidewire delivery function into multiple independent guidewires (first guidewire, second guidewire, third guidewire, etc.) that can be individually controlled. Each guidewire can be advanced or retracted independently through the guide catheter, allowing selective positioning to cross the stenosed aortic leaflets while maintaining overall system manageability through modular design
Solution Approach 2:
The control device enables dynamic adjustment of each guidewire's position independently. The operator can advance specific guidewires (e.g., first guidewire to first position, second guidewire to second position) while retracting others, creating a flexible, adaptive system that responds to real-time procedural needs rather than requiring all guidewires to be in fixed positions simultaneously
2Productivity
If guidewires are advanced through the guide catheter to cross aortic leaflets, then the productivity of the procedure is improved, but the risk of guidewire entanglement and misalignment increases
Solution Approach 1:
The guide catheter serves as an intermediary structure that receives and organizes multiple guidewires at its proximal end. The control device acts as a mediator between the operator and the guidewires, providing a centralized interface for advancing or retracting each guidewire independently. This intermediary architecture prevents direct interaction between guidewires that would cause entanglement, while enabling efficient control that improves procedural productivity
3Loss of time
If stenosed aortic leaflets are crossed with traditional guidewires, then the procedure time increases, but the difficulty of crossing the leaflets remains high
Solution Approach 1:
The system performs preliminary positioning of multiple guidewires within the guide catheter before attempting to cross the stenosed aortic leaflets. The control device allows pre-advancement of specific guidewires to optimal positions, and the operator can select which guidewire to advance based on anticipated leaflet geometry. This preliminary preparation reduces the number of attempted crossings needed, thereby reducing procedure time while maintaining ease of operation
Data Source
AI summary
An aortic leaflet crossing system includes a guide catheter defining a guide lumen therein. The guide catheter has a proximal end defining a proximal opening and a distal end defining a distal opening. The aortic leaflet crossing system further includes a plurality of guidewires extending into the proximal opening and through the guide lumen and out of the distal opening. The aortic leaflet crossing system also includes a control device configured to advance the plurality of guidewires such that at least one of the guidewires crosses aortic leaflets of an aortic valve and to retract guidewires in the plurality of guidewires that do not cross the aortic leaflets.