Extended-Tip Dilator Navigation for Right Heart Catheter Access
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Solution Overview
Problem
Existing minimally invasive transcatheter delivery systems face challenges in maintaining steering capabilities while maximizing catheter payload and reducing the number of steps required to reach the target site, particularly due to the need for multiple guidewires and catheters, and the mismatch between guidewire flexibility and delivery device stiffness.
Innovation Solution
A delivery system with a dilator having a tapered distal tip and extended length, integrated with a steering ring and pull wires, allows for simultaneous advancement of the delivery catheter over the dilator, eliminating the need for microcatheters and reducing the number of guidewire exchanges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If steering capabilities are added to delivery devices, then steering capability is improved, but payload capability deteriorates
Solution Approach 1:
The delivery system is divided into separate functional components: a delivery catheter for payload and a separate steerable dilator for navigation. This segmentation allows each component to be optimized independently - the catheter maintains maximum inner diameter for payload while the dilator provides steering capability through integrated pull wires and steering ring
Solution Approach 2:
The dilator acts as an intermediary component between the guidewire and the delivery catheter. It provides the steering function during navigation, then is removed to allow the delivery catheter to proceed without obstruction, thus maintaining payload capability while providing steering when needed
2Reliability
If multiple guidewires and catheters are used for delivery, then reliability of reaching target site is improved, but device complexity and number of steps worsen
Solution Approach 1:
The steerable dilator combines multiple functions into a single component: it serves as both the delivery vehicle for the catheter and the steering mechanism. The pull wires are integrated within the dilator structure, eliminating the need for separate steering devices and reducing the overall number of components required
Solution Approach 2:
The dilator performs multiple functions: it provides initial access through the vasculature, offers steerable navigation to the target site, supports the delivery catheter during advancement, and can be removed to allow final positioning. This multi-functionality reduces the need for multiple specialized devices
3Productivity
If delivery catheter is advanced directly over guidewire, then productivity is improved, but reliability deteriorates due to flexibility mismatch
Solution Approach 1:
The dilator's physical parameters are specifically designed to bridge the gap between guidewire and catheter requirements. Its outer diameter is sized to fit within the catheter lumen while providing sufficient structural support, and its length extends beyond the catheter distal end to provide adequate steering control during navigation
Data Source
AI summary
According to one aspect of the disclosure, a method of advancing a delivery catheter to a heart of a patient includes advancing a guidewire through the vasculature of the patient until the guidewire reaches a target treatment site in or adjacent to the heart. A dilator may be positioned within the delivery catheter so that a distal tip of the dilator extends beyond a distal end of the delivery catheter. The dilator may be advanced through the vasculature of the patient directly over the guidewire while simultaneously advancing the delivery catheter through the vasculature until the distal tip of the dilator reaches the target treatment site. While maintaining the distal tip of the dilator substantially stationary relative to the target treatment site, the delivery catheter may be advanced over the dilator until the distal end of the delivery catheter is positioned at the target treatment site.