Steerable Dilator-Guided Catheter Access for Right Heart Delivery
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Solution Overview
Problem
Existing delivery devices for medical implants to 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 a steering ring, coupled with a pull wire or steering cable, is used to advance a delivery catheter over a guidewire, allowing for extended length and steering capabilities without increasing the delivery catheter's wall thickness, thus maintaining a large inner diameter for the payload.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If steering capability is added to delivery devices, then navigation capability through tortuous pathways 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 dilator with integrated steering mechanism for navigation. This segmentation allows each component to be optimized independently, enabling the delivery catheter to maintain large inner diameter while the dilator provides steering capability.
Solution Approach 2:
The dilator acts as an intermediary component that combines both steering functionality and payload delivery capability. By positioning the dilator within the delivery catheter, the system achieves steering capability without compromising the delivery catheter's payload capacity, as the dilator's steering mechanisms do not extend through the delivery catheter wall.
2Reliability
If multiple guidewires and catheters are used to reach target site, then delivery capability is improved, but number of steps is increased
Solution Approach 1:
The system merges multiple functions into a single integrated delivery catheter that combines guidewire support, steerable navigation, and payload delivery capabilities. This eliminates the need for sequential exchange of multiple guidewires and catheters, reducing procedural steps while maintaining reliable delivery to the target site.
Solution Approach 2:
The delivery catheter is designed with universal functionality to perform multiple tasks: supporting the guidewire, providing steerable navigation through tortuous pathways, and delivering the payload device. This multi-functionality consolidates what would traditionally require multiple separate devices into a single unified system.
3Ease of operation
If delivery catheter wall thickness is increased to accommodate steering cables, then steering capability is improved, but inner diameter is reduced
Solution Approach 1:
The steering cables and steering ring are extracted from the delivery catheter structure and relocated to the dilator. This extraction allows the delivery catheter to maintain thin walls and large inner diameter, while the dilator independently provides the necessary steering capability through its own integrated steering mechanisms.
Solution Approach 2:
The dilator serves as an intermediary that houses the steering cables and ring, acting as a separate steerable component that works in conjunction with the delivery catheter. This arrangement allows steering functionality to be achieved without increasing delivery catheter wall thickness or reducing its inner diameter.
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.