Nested Mitral Valve Delivery Sheaths for Multi-Angle Steering
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Solution Overview
Problem
Existing delivery systems for mitral valve repair, particularly the transseptal technique, lack flexibility and are not capable of multi-angle conversion, making them difficult to operate and requiring high technical expertise, thus limiting their clinical use.
Innovation Solution
A delivery system comprising a sheath assembly with nested inner, middle, and outer sheaths, each with varying hardness and deflection capabilities, and pull wires to facilitate multi-angle adjustments, enhancing flexibility and reducing operation difficulty.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a traditional delivery system is used for transseptal mitral valve repair, then the procedure can be performed with a simple structure, but the system lacks flexibility and cannot achieve multi-angle conversion
Solution Approach 1:
The delivery system employs a nested sheath structure where an inner sheath is positioned within a middle sheath, which is in turn positioned within an outer sheath. Each sheath can slide relative to the others along the axial direction, enabling the system to achieve multi-angle conversion and flexible positioning while maintaining a relatively compact and manageable overall structure.
Solution Approach 2:
The delivery system incorporates dynamic elements including pull wires that can be independently actuated to deflect the distal ends of each sheath by predetermined angles in different directions. This dynamic capability allows the system to adapt to various anatomical configurations and achieve precise multi-angle positioning during the procedure.
2Adaptability or versatility
If the delivery system is made more flexible with multi-angle conversion capability, then adaptability improves, but the operation becomes more difficult and requires higher technical expertise
Solution Approach 1:
The delivery system is segmented into multiple independently controllable components - the inner sheath, middle sheath, and outer sheath, each with its own pull wire mechanism. This segmentation allows the operator to control each sheath's deflection independently, simplifying the operation by breaking down complex positioning tasks into manageable steps rather than requiring simultaneous control of a single complex component.
Solution Approach 2:
Pull wires serve as intermediary elements that transmit operator input to the sheath structures. Each pull wire is configured to deflect its associated sheath distal end by a predetermined angle when pulled, providing a mechanical advantage that simplifies the operator's task while achieving precise angular positioning of the delivery system.
3Adaptability or versatility
If the sheath structure is made more complex to achieve multi-angle conversion, then flexibility improves, but the system becomes unstable and shifts during delivery
Solution Approach 1:
The sheath structures exhibit varying hardness along their lengths, with the proximal ends being harder and the distal ends being softer. This local quality differentiation provides structural stability at the proximal ends during delivery and manipulation, while the softer distal ends maintain flexibility for deflection and adaptation to anatomical structures, thereby achieving both stability and flexibility simultaneously.
Solution Approach 2:
The nested sheath configuration provides inherent stability during delivery, as each sheath is supported by the others within the nested arrangement. This nested structure prevents individual sheaths from shifting independently while still allowing controlled relative movement when pull wires are actuated, maintaining system stability while enabling flexibility when needed.
Data Source
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AI summary
A delivery system for mitral valve repair is provided. The delivery system for mitral valve repair includes an inner sheath (3), a middle sheath (2), an outer sheath (1), a first pull wire, a second pull wire, and a push-pull wire. The inner sheath (3), the middle sheath (2), and the outer sheath (1) are nested from inside to outside in sequence and slidably connected along an axial direction of the inner sheath (3). The first pull wire is used to pull the outer sheath (1) and the second pull wire is used to pull the middle sheath (2) so that an outer sheath distal end (12) and a middle sheath distal end (22) can be deflected by different angles in different directions, thereby increasing the flexibility of the delivery system when delivering a device to be delivered (100).