Endoscopic Suture Closure With Locking Shuttle for Large Defects
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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 bariatric revision procedures, due to limitations in current devices and techniques.
Innovation Solution
A suture device designed for use with an endoscope, featuring a needle with a distal end and a distal detent, a needle cap, a distal shuttle, and a sleeve that moves between locked and unlocked positions, allowing for precise suture deployment and retrieval, and a control mechanism for manipulating the needle within the endoscope's working channel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If existing endoscopic closure methods are used, then small defects can be closed, but large defects cannot be effectively closed
Solution Approach 1:
The suture device divides the closure process into discrete segments: needle insertion, suture deployment, tissue grasping, and knot tying. The needle itself is segmented with a shaft, hub, and detachable tip, allowing controlled delivery through the endoscope while maintaining the ability to handle large tissue defects that exceed the scope of traditional single-piece closure devices.
2Manufacturing precision
If a suture device with multiple components is used, then precise suture deployment is achieved, but device complexity increases
Solution Approach 1:
The device employs a nested structure where the needle is inserted through the endoscope, the suture is threaded through the needle, and the distal shuttle is positioned within the needle hub. The sleeve encompasses the distal shuttle and needle assembly. This nesting allows precise deployment of multiple components through a single endoscope working channel while maintaining control over each component's positioning and function.
Solution Approach 2:
The distal shuttle acts as an intermediary mechanism between the operator and the needle-suture assembly. It provides a controlled interface for advancing and retracting the needle, managing suture deployment, and facilitating knot tying. The shuttle's interaction with the sleeve (locked/unlocked positions) creates a mediated control system that simplifies the operation of the complex multi-component device.
3Ease of manufacture
If manual suture manipulation is performed, then closure can be achieved, but multiple individuals are required
Solution Approach 1:
The suture device is designed to be self-contained and self-manipulating. The distal shuttle automatically advances and retracts the needle, the sleeve controls the locking mechanism, and the suture feeds through integrated channels. Once deployed, the device can tie its own knots and secure the suture without requiring external manipulation by multiple operators, allowing a single endoscopist to perform the entire closure procedure.
4Object-affected harmful factors
If traditional closure methods are used, then small wounds are closed, but tissue damage increases for large defects
Solution Approach 1:
The suture device uses a flexible needle shaft that can navigate through the endoscope's working channel and conform to the curvature of the gastrointestinal tract. The suture itself is a flexible strand that can span large tissue defects without causing excessive tension or damage to the surrounding tissue. This flexibility allows the device to adapt to large defects while minimizing harmful mechanical stress on the tissue.
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. A shaft is operably coupled to the sleeve and a control wire is operably coupled to the distal shuttle. A needle may include a needle cap.


