Steerable Dilator-Guided Catheter Access for Right Heart Delivery
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Solution Overview
Problem
Existing medical delivery devices for the heart face challenges in maintaining steering capabilities while maximizing catheter payload and reducing the number of steps required to reach the target site, often necessitating multiple guidewires and catheters due to the tortuous vascular pathways.
Innovation Solution
A delivery system with a dilator having a tapered distal tip and integrated steering capabilities, allowing for a single guidewire to support both the dilator and delivery catheter, 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 navigation through tortuous vasculature is improved, but payload capability is reduced
Solution Approach 1:
The delivery system is divided into separate functional components: a delivery catheter for payload transport and a separate steerable dilator for navigation. This segmentation allows each component to be optimized independently - the catheter maintains large diameter for payload while the dilator provides steering without compromising catheter payload capacity.
Solution Approach 2:
The steerable dilator acts as an intermediary component that provides steering capability during delivery. It can be advanced over the guidewire and used to steer the delivery catheter through tortuous vasculature, then removed to allow the delivery catheter to proceed to the target site without the steering mechanism interfering with payload delivery.
2Ease of operation
If multiple guidewires and catheters are used to reach the target site, then navigation capability is improved, but the number of steps and procedure complexity increase
Solution Approach 1:
The steerable dilator combines multiple functions into a single device: it provides guidewire support, enables steering through tortuous vasculature, and serves as a delivery mechanism for the catheter. This multi-functionality eliminates the need for separate microcatheters and multiple guidewires, reducing procedural steps while maintaining navigation capability.
Solution Approach 2:
The invention merges the steering mechanism and dilator functions into a single integrated component that can be advanced over a standard guidewire. This combination allows the delivery system to navigate tortuous pathways and deliver the catheter in a single continuous action, eliminating the need for multiple catheter exchanges and reducing overall procedure complexity.
3Quantity of substance
If the delivery catheter inner diameter is increased to maximize payload, then payload capacity is improved, but the ability to navigate tortuous vasculature worsens
Solution Approach 1:
The system separates the navigation function (performed by the steerable dilator with smaller diameter) from the payload delivery function (performed by the larger diameter catheter). The dilator can navigate tortuous vasculature and steer to the target, then the catheter is advanced over it to deliver the payload without navigation constraints.
Solution Approach 2:
The steerable dilator performs preliminary navigation and positioning actions before the delivery catheter is advanced. By first navigating the dilator through the tortuous vasculature to the target site, the path is prepared and confirmed, allowing the larger payload-carrying catheter to be advanced directly to the target without needing to navigate the same tortuous path independently.
Data Source
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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.