Collet Hemostasis Clip Deployment for Faster Endoscopic Closure
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Solution Overview
Problem
Current endoscopic closure devices are difficult to use, time-consuming, and insufficient for certain perforations and anatomies, particularly in aggressive interventional and therapeutic gastrointestinal procedures, often requiring multiple clips and generating shed parts that may embed in tissue defects.
Innovation Solution
A clipping system with a collet-mounted clip that deploys via a catheter, featuring a yoke connection that separates at a predetermined force, allowing for controlled movement between open and closed configurations, and a collet that releases from the clip upon deployment, minimizing shed parts and improving maneuverability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If current endoscopic closure devices are used, then tissue closure function is provided, but the devices are difficult to use and time-consuming to position
Solution Approach 1:
The clip is pre-loaded into the insertion device in an open configuration before insertion, with the control member already positioned to enable immediate actuation. This preliminary preparation eliminates the need for complex positioning maneuvers during the procedure, allowing the operator to simply advance the device and actuate the clip at the target site.
Solution Approach 2:
The insertion device is divided into distinct functional segments: the insertion device for delivery, the clip with separate arms for closure, and the control member for actuation. This segmentation allows each component to be optimized independently and simplifies the overall operation by separating the delivery function from the closure function.
2Area of stationary object
If multiple clips are required for larger defects, then adequate coverage is achieved, but device complexity and procedure time increase
Solution Approach 1:
The clip arms are designed to be dynamically adjustable between open and closed configurations through the control member. This dynamic capability allows a single clip to adapt to various defect sizes and shapes, eliminating the need to pre-determine the number and size of clips required before the procedure.
Solution Approach 2:
The clip design provides multi-functionality by being able to closure defects of varying sizes through adjustment of the arm separation distance. The same clip device can handle small hemostasis needs as well as larger defect closures, replacing the need for multiple specialized clip sizes.
3Object-affected harmful factors
If traditional clip deployment methods are used, then clips can be inserted through endoscope, but shed parts may embed in tissue defects
Solution Approach 1:
The excess portion of the control member that remains after clip deployment is deliberately designed to be detachable and is extracted from the body along with the insertion device. This separation eliminates the risk of shed parts embedding in tissue, as the control member is removed in one piece rather than leaving fragments behind.
Solution Approach 2:
The yoke serves as an intermediary component that connects the control member to the clip arms during deployment, then separates at a predetermined force threshold. This controlled separation mechanism ensures that no parts remain embedded in the tissue, as both the yoke and control member are designed to detach cleanly and be removed with the insertion device.
4Force
If clip arms are constrained toward closed configuration, then tissue gripping force is improved, but maneuverability and visualization are reduced
Solution Approach 1:
The clip arms transition from a dynamic open configuration during insertion and positioning to a closed configuration during tissue gripping. This dynamic transformation allows the system to optimize for visualization and maneuverability during approach, then maximize gripping force during the closure function.
Solution Approach 2:
The clip arms move from a separated spatial arrangement in the open configuration to a converged arrangement in the closed configuration. This dimensional change allows the distal ends to come together and apply concentrated gripping force on the tissue while the proximal ends remain connected through the capsule and control member mechanism.
Data Source
AI summary
A clipping system includes a device including longitudinal slots extending through a wall thereof and a clip releasably received within a distal portion of the device. The clip includes a capsule and a pair of clip arms. Proximal ends of the arms are slidably received within the capsule and a collet is slidably mounted over the device movable between an insertion configuration, in which the collet is positioned over the distal portion of the device pressing the distal portion against the capsule and a deployed configuration, in which the collet is proximal of the distal portion so that the clip is releasable from the device. A control member extends through the channel of the device to couple to the proximal ends of the arms and a portion of the collet. Movement of the member opens and closes the clip and moves the collet between the insertion and deployed configurations.