Catheter Alignment Loop for Guidewire Placement Across Heart Valves
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Solution Overview
Problem
Crossing aortic valves with guidewires for delivering interventional tools or prosthetic devices is challenging due to varying anatomies and calcified valves, which can lead to difficulties in alignment and increased risk of cardiac tissue perforation and emboli dislodgement.
Innovation Solution
Catheter assemblies with alignment features, such as a tubular component with a loop configuration and side ports, are used to stabilize and align guidewires across heart valves, allowing for axial movement to transform between delivery and deployed configurations for precise guidewire placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If guidewires are advanced across calcified aortic valves using conventional catheter-based systems, then interventional tools and prosthetic devices can be delivered percutaneously, but alignment difficulties arise due to varying anatomies and valve calcification, increasing the risk of cardiac tissue perforation and emboli dislodgement
Solution Approach 1:
The catheter shaft is divided into multiple segments including a proximal shaft, a mid-portion, and a distal shaft with alignment features. This segmentation allows each portion to be optimized for specific functions: the proximal shaft for delivery, the mid-portion for transition, and the distal shaft with alignment features for precise guidewire placement across the valve.
Solution Approach 2:
Alignment features such as alignment fins or alignment wires are introduced as intermediary elements between the catheter and the guidewire. These features act as mediators that guide and constrain the guidewire trajectory, ensuring proper alignment across the aortic valve while preventing deviation that could cause tissue perforation or emboli dislodgement.
2Measurement precision
If the catheter shaft is made rigid to maintain alignment, then guidewire placement precision improves, but the catheter cannot navigate through tortuous vasculature to reach the target valve
Solution Approach 1:
The catheter shaft incorporates dynamic characteristics with varying flexibility along its length. The proximal and mid-portions are more flexible to navigate tortuous vasculature, while the distal portion contains rigid alignment features that provide stability and precision during guidewire placement. This dynamic flexibility gradient allows the catheter to adapt to different anatomical conditions while maintaining placement accuracy.
Solution Approach 2:
Different portions of the catheter shaft have different mechanical properties tailored to their specific functions. The proximal and mid-portions have higher flexibility for navigation, while the distal portion has increased rigidity through alignment features for precise guidewire positioning. This local differentiation of mechanical properties resolves the contradiction between navigability and placement precision.
3Manufacturing precision
If alignment features are added to the catheter shaft, then guidewire placement accuracy improves, but device complexity increases
Solution Approach 1:
The alignment features are segmented and distributed along the distal portion of the catheter shaft rather than being concentrated in one location. This segmentation allows for modular manufacturing and assembly, reducing overall device complexity while maintaining placement accuracy through multiple distributed alignment points.
Solution Approach 2:
Instead of making the entire catheter shaft complex with alignment features throughout, the invention inverts the approach by concentrating alignment features only in the distal portion where they are most needed for guidewire placement. The proximal and mid-portions remain simple and flexible, reducing overall device complexity while maintaining placement accuracy at the critical interface with the guidewire.
Data Source
AI summary
Transcatheter guidewire delivery systems, catheter assemblies and associated methods for percutaneous guidewire delivery across heart valves are disclosed herein. A catheter assembly configured in accordance herewith includes an elongated tubular component and an alignment assembly at a distal portion of the tubular component and which is adapted to be located at a target location adjacent a heart valve of a patient. In one embodiment, the alignment assembly deploys to a shape set loop configuration with a side port in an open configuration positioned to allow advancement of a guidewire to exit the catheter in an aligned path with a leaflet coaptation region of the heart valve. In another embodiment, the alignment assembly has a plurality of spaced apart side ports that a guidewire may advance therethrough and toward the heart valve. In some embodiments, a wire guide is used to align the guidewire with a selected side port.