Cinch Ligating Assembly for Controlled Tissue Repositioning
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Solution Overview
Problem
Conventional ligating loops and clip deployment devices are prone to inadvertent release or cinching, complicating their use and increasing the risk of unintentional deployment, particularly in procedures involving tissue removal such as pedunculated polyps or gastric lesions.
Innovation Solution
A ligating assembly with a cinch component and hook mechanism that allows for controlled, irreversible tightening of a loop or clip around tissue, featuring a pusher tube and drive wire system with independent handle controls to ensure precise deployment and repositioning, reducing the risk of accidental release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional ligating loop device uses an irreversible handle mechanism to cinch the loop, then the loop can be securely tightened around tissue, but the device becomes prone to unintentional deployment and lacks controlled release capability
Solution Approach 1:
The handle mechanism is divided into two separate handles: a first handle that controls extension/retraction of the ligating loop, and a second handle that controls cinching/release of the loop. This segmentation allows independent control of each function, preventing unintentional deployment while enabling secure tightening when needed.
Solution Approach 2:
A drive wire acts as an intermediary mechanism that transmits mechanical force from the handles to the ligating loop and cinch component. The drive wire connects the handle mechanisms to the distal end components, enabling controlled transmission of forces for both extension and cinching operations without direct mechanical linkage that could cause unintended movement.
2Adaptability or versatility
If the handle mechanism independently controls extension and retraction of the ligating loop, then the loop can be positioned flexibly, but unintentional deployment and cinching occurs
Solution Approach 1:
The control system is segmented into two independent handle mechanisms: the first handle independently controls extension and retraction of the ligating loop through the drive wire, while the second handle independently controls the cinching and release of the loop. This independent control prevents unintentional deployment while maintaining positioning flexibility.
Solution Approach 2:
The system requires deliberate preliminary actions for each operation: the operator must intentionally actuate the first handle for extension, then separately actuate the second handle for cinching. This sequential preliminary action ensures that each step is intentional and prevents accidental deployment during positioning.
3Object-affected harmful factors
If the ligating loop is designed to be irreversibly cinched around tissue, then blood flow restriction is effective, but the device cannot be easily repositioned or adjusted
Solution Approach 1:
The system provides dynamic control through two independent handles that allow the operator to transition between different states: the first handle enables extension and retraction for repositioning, while the second handle enables cinching for blood flow restriction. This dynamic control allows the loop to be repositioned before final cinching, and the cinched state can be released if repositioning is needed.
Solution Approach 2:
The operator can perform preliminary positioning actions using the first handle to extend and retract the loop, adjusting its position around the tissue before finalizing with the second handle. This preliminary action allows flexible positioning while maintaining the ability to achieve effective blood flow restriction through the cinching mechanism.
Data Source
AI summary
A device and assembly for ligating a target tissue to restrict blood flow to the tissue, where the device is a ligating device that is irreversibly tightened by a cinch component. The device further has a hook to hold the ligating element on a delivery tool. The ligating element can be a continuous loop or can be a clip and can be repositionable until the cinch is used to tighten it. The cinch holds the ligating device on the loop while being positioned, and then secures the ligating device once it is positioned around target tissue to which a user desires to restrict blood flow. A method of using the assembly includes an actuator assembly, drive wire, and pusher element to manipulate the ligating device and cinch component.