Steerable Catheter for Tortuous Vasculature Navigation
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Solution Overview
Problem
Current endovascular delivery systems face challenges in navigating through small vessels and tight bends in the vasculature, particularly for retrograde delivery of prosthetic aortic heart valves, due to the long stiff section of the delivery apparatus, which limits successful implantation and requires the use of introducer sheaths that can cause trauma and occlusion.
Innovation Solution
A delivery apparatus comprising a balloon catheter with a guide catheter and a nose catheter, where the guide catheter has a steerable section with an adjustment mechanism for 1:1 movement and a nose piece with a tapered outer surface for atraumatic tracking, allowing the apparatus to be advanced through tortuous vasculature without an introducer sheath, reducing occlusion and trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a conventional delivery apparatus with a long stiff section is used, then the structural integrity and support are maintained, but the ability to navigate through tortuous vasculature is significantly reduced
Solution Approach 1:
The delivery apparatus is divided into distinct segments: a steerable section with adjustable curvature, a non-steerable section, and a delivery section. This segmentation allows the steerable portion to navigate tortuous vasculature while the non-steerable section provides structural support, resolving the contradiction between navigability and structural integrity.
Solution Approach 2:
The delivery apparatus incorporates an adjustable steerable section that can dynamically change its curvature in response to vascular anatomy. The curvature adjustment mechanism allows the apparatus to adapt to different tortuous paths, enabling navigation through complex vasculature without requiring a permanently long stiff section.
2Reliability
If an introducer sheath is used to introduce the delivery apparatus, then safe introduction into vasculature is achieved, but vascular trauma and occlusion are increased
Solution Approach 1:
The delivery apparatus utilizes a flexible catheter construction with a non-steerable section that provides protection during introduction without requiring a rigid introducer sheath. The flexible nature of the catheter allows it to conform to vascular walls, minimizing trauma and occlusion while maintaining safe introduction capabilities.
3Object-affected harmful factors
If a tapered nose piece is added to facilitate atraumatic tracking, then vascular trauma is reduced, but the device complexity increases
Solution Approach 1:
The tapered nose piece is applied locally to the distal end of the delivery apparatus, providing atraumatic tracking characteristics only where needed during vascular navigation. This localized application reduces overall device complexity while still achieving the benefit of reduced vascular trauma at the critical interface with blood vessels.
Data Source
AI summary
Assemblies and delivery apparatus for delivering a medical device into a patient's vasculature are disclosed. In some examples, an assembly includes a delivery apparatus and a radially compressible and expandable prosthetic heart valve. The delivery apparatus includes a handle, a first shaft and a second shaft extending from the handle, and a locking mechanism to prevent axial movement of the second shaft relative to first shaft. The second shaft extends coaxially through the first shaft and includes, at a distal end portion thereof, a balloon, one or more radiopaque markers, and the prosthetic valve radially compressed over the balloon. A flared end piece extending from the first shaft covers a proximal portion of the balloon during advancing of the delivery apparatus through a patient's vasculature. The first shaft is retractable relative to the second shaft to expose the balloon from the flared end piece.