Articulation Sheath Delivery System for Cardiac Device Placement
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Solution Overview
Problem
Current delivery systems for implantable cardiac medical devices face challenges in navigation and deployment, particularly for compact devices, due to mechanical complications and MRI compatibility issues associated with elongate lead wires, necessitating a more sophisticated system for precise placement within the heart.
Innovation Solution
A delivery system assembly comprising an elongate outer tube, an inner member, and an articulation sheath that allows for longitudinal movement and deflection to orient the distal portion of the outer tube, facilitating navigation and deployment of implantable medical devices within the venous system, with features like a pull-wire member and pre-formed curvature for enhanced maneuverability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a standard guiding catheter is used to deliver the implantable device, then the device can be delivered through the venous system, but the navigation and deployment precision is insufficient for compact devices
Solution Approach 1:
The delivery system is divided into multiple functional segments: an outer tube for device containment, an inner member for articulation control, and an articulation sheath for directional guidance. This segmentation allows each component to perform its specific function independently, improving deployment precision without requiring a completely complex new system design.
Solution Approach 2:
The inner member is nested within the outer tube, and the articulation sheath surrounds the outer tube. This nested configuration allows multiple functional elements to be integrated in a compact manner, providing sophisticated navigation capabilities while maintaining a relatively simple overall structure that can be delivered through standard venous access.
2Ease of operation
If the outer tube is made larger to facilitate device delivery, then the device can be easily delivered, but the ability to navigate through the venous system is reduced
Solution Approach 1:
The delivery system separates the functions of device containment and articulation control into different components. The outer tube provides a stable platform for device delivery, while the articulation sheath and inner member provide flexible navigation capabilities. This allows the outer tube to maintain sufficient size for easy device delivery without compromising navigation speed.
Solution Approach 2:
The articulation sheath can be dynamically deflected by the inner member to change the orientation of the distal portion of the outer tube. This dynamic articulation capability allows the delivery system to navigate through the venous system efficiently while maintaining the outer tube's structural integrity and adequate dimensions for device delivery.
3Measurement precision
If the distal portion of the outer tube is oriented precisely, then the device can be positioned accurately at the target site, but the navigation through the venous system becomes more difficult
Solution Approach 1:
The articulation sheath is designed with a pre-formed curvature that can be selectively deflected. This curved configuration allows the distal portion of the outer tube to be oriented precisely at the target site while the proximal portion maintains a smoother path through the venous system, easing navigation through complex vascular anatomy.
Solution Approach 2:
The inner member acts as an intermediary between the operator and the articulation sheath. By manipulating the inner member, the operator can control the deflection of the articulation sheath and thus the orientation of the distal portion of the outer tube, achieving precise positioning without directly manipulating the outer tube itself, which simplifies navigation.
Data Source
AI summary
A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.