Expandable Sheath Introducer Locking Hub Mechanism
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Solution Overview
Problem
Conventional introducer sheaths for endovascular systems are not optimized for the post-insertion phase of delivering valves and other prosthetic devices, leading to vessel trauma, prolonged procedure times, and increased risk of trauma due to inadequate snug fit and lack of smooth transition during insertion and retrieval.
Innovation Solution
An introducer sheath system with a locking hub mechanism that fixes the axial position of the introducer and sheath, using a hypotube to control the movement of the introducer pieces, ensuring a snug fit and preventing separation during insertion, and allowing for temporary expansion of the sheath for device delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional introducer sheaths are used for delivery, then the procedure can be performed, but vessel trauma occurs and procedure time is prolonged due to inadequate snug fit and lack of smooth transition
Solution Approach 1:
The introducer is divided into a proximal piece and a distal piece that can move independently. The distal piece can be advanced separately to expand the sheath, then the proximal piece is advanced to provide a smooth transition. This segmentation allows each piece to perform its specific function optimally, preventing vessel trauma while maintaining efficient procedure flow.
Solution Approach 2:
The distal piece of the introducer is advanced first to expand the sheath to the desired diameter before advancing the proximal piece. This preliminary expansion action ensures the sheath is properly sized and sealed before the main delivery operation, preventing trauma during subsequent device passage.
2Ease of operation
If the introducer is advanced through the sheath, then device delivery is enabled, but the introducer and sheath may separate creating a gap that causes vessel trauma
Solution Approach 1:
The introducer is designed with dynamic movement capability between a compressed state (for insertion) and an expanded state (for delivery). The distal piece can expand the sheath while maintaining contact, then the proximal piece advances to create a smooth, continuous transition surface. This dynamic design prevents gap formation while enabling easy device delivery.
Solution Approach 2:
The proximal piece is received within the distal piece during insertion, creating a nested configuration. As the proximal piece advances, it maintains continuous contact with the distal piece, creating a smooth transition surface. This nesting arrangement ensures the sheath remains securely advanced without gaps while allowing easy device passage.
3Device complexity
If a single introducer is used for both insertion and delivery, then the procedure is simplified, but the introducer cannot be retrieved or repositioned
Solution Approach 1:
The introducer is segmented into proximal and distal pieces that can move independently. The distal piece remains in place to maintain the expanded sheath configuration for device delivery, while the proximal piece can be retrieved or repositioned. This segmentation provides both structural simplicity for insertion and versatility for subsequent operations.
Solution Approach 2:
The introducer transitions from a static single-piece design to a dynamic two-piece system where the proximal piece can be advanced, retrieved, or repositioned independently of the distal piece. This dynamic design maintains the expanded sheath configuration while enabling flexibility for retrieval and repositioning operations.
Data Source
AI summary
An introducer sheath system is disclosed herein that includes an introducer locking hub, an introducer coupled to the introducer locking hub, and a hypotube disposed within the central lumen of the introducer. The introducer locking hub prevents axial and rotational translation of the introducer with respect to the sheath. The introducer defines an elongated body having a proximal piece and a separate distal piece, the proximal piece coupled to the introducer locking hub and the distal piece coupled to the distal end of the hypotube. The body portion of the hypotube is slidably disposed within the central lumen of the proximal piece of the introducer such that movement of the hypotube within the central lumen of the proximal piece causes the distal piece of the introducer to move with respect to the proximal piece.