Endoscopic Suture Shuttle and Curved Guide for Large Defect Closure
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Solution Overview
Problem
Existing endoscopic closure methods are inadequate for large defects, such as those resulting from treatments like large lesion removal or post-surgical leaks, due to limitations in existing devices and methods.
Innovation Solution
A suture device with a suture translation assembly and an elongate tool guide that can transition between deployment and working configurations, allowing for precise suturing through an endoscope or similar delivery system, featuring a distal assembly with a guide member and endcap for needle management and a polymeric tubular member for tool guidance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single working channel endoscope is used, then device complexity is reduced and ease of operation is improved, but the ability to close large defects is limited compared to dual-channel systems
Solution Approach 1:
The suture device integrates multiple functions (suturing, tissue grasping, and defect closure) into a single working channel system. The distal assembly can perform suturing operations and deploy closure devices through the same channel, eliminating the need for separate channels while maintaining the ability to close large defects.
Solution Approach 2:
The suture needle and suture translation assembly are nested within the distal assembly, which itself is delivered through the endoscope working channel. The elongate tool guide is positioned within the distal assembly, allowing compact delivery while enabling deployment of multiple components through the single channel.
2Measurement precision
If an elongate tool guide is positioned to curve away from the distal assembly in working configuration, then tool guidance precision is improved, but device complexity increases
Solution Approach 1:
The elongate tool guide transitions between a straight configuration during delivery and a curved configuration during working operations. This dynamic reconfiguration allows the guide to provide precise tool guidance when needed while maintaining a compact delivery profile, managed through the pivot structure that allows controlled movement between states.
3Ease of operation
If the polymeric tubular member is expanded in working configuration, then tool guidance capability is improved, but the device volume increases
Solution Approach 1:
The polymeric tubular member transitions from a collapsed state during delivery to an expanded state during working operations. This dynamic volume change allows the member to provide adequate tool guidance and structural support when needed while minimizing the overall device volume during delivery through the endoscope channel.
Data Source
AI summary
A suture device for use in combination with a delivery system including a lumen extending through the delivery system includes a needle usable to carry a suture, a distal shuttle configured to releasably secure the needle, a sleeve disposable over the distal shuttle, the distal shuttle movable relative to the sleeve between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is releasable from the distal shuttle. The suture device includes a distal assembly including an elongate tool guide movable between a deployment configuration in which the elongate tool guide is substantially parallel with the distal assembly and a working configuration in which the elongate tool guide curves away from the distal assembly.