Collet-Held Hemostasis Clip for Fast Endoscopic Deployment
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Solution Overview
Problem
Current endoscopic closure devices are difficult to use, time-consuming, and insufficient for certain perforations and anatomies, often requiring multiple clips and generating shed parts that may embed in tissue defects.
Innovation Solution
An endoscopic clipping system with a clip releasably coupled to a catheter via a collet, allowing for deployment without reengagement and featuring a separable yoke to minimize shed parts, and a shortened design for improved visualization and maneuverability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a traditional clip delivery system is used, then the delivery system is simple in structure, but the clip arms cannot be pre-assembled in the closed configuration, requiring manual assembly during the procedure which increases procedure time and risk of contamination
Solution Approach 1:
The clip arms are pre-assembled in the closed configuration within the capsule, which is then nested within the delivery system. The collet compresses the capsule to maintain the clip arms in the closed configuration during delivery, eliminating the need for manual assembly during the procedure.
Solution Approach 2:
The clip arms are pre-assembled in the closed configuration before the procedure begins. The delivery system is designed to maintain this pre-assembled state through the collet compression mechanism, allowing the clip to be ready for immediate deployment without requiring manual assembly during the procedure.
2Reliability
If the clip is delivered in an open configuration, then the clip can be easily deployed, but the clip arms may inadvertently close during delivery causing embolization or blocking the delivery system
Solution Approach 1:
The system transitions from a static open configuration to a dynamic controlled state. The collet applies compressive force to maintain the clip arms in the closed configuration during delivery, and this force is released upon deployment to allow the clip arms to open for embolization.
Solution Approach 2:
The mechanical state of the clip arms is changed from open to closed configuration through the application of compressive force by the collet. This parameter change (configuration state) is maintained during delivery and then reversed upon deployment to achieve safe and effective delivery.
3Productivity
If the clip arms are pre-assembled in the closed configuration, then the clip is ready for immediate use, but the delivery system must maintain this configuration which increases system complexity
Solution Approach 1:
The capsule containing the pre-assembled clip arms is nested within the delivery system, and the collet is nested over the capsule. This nested structure allows the pre-assembled clip to be maintained in the closed configuration without requiring complex external support mechanisms.
Solution Approach 2:
The collet compression mechanism automatically maintains the clip arms in the closed configuration through mechanical compression, eliminating the need for active control systems or additional components to hold the clip arms in place during delivery.
4Reliability
If the capsule is held in the distal portion of the catheter, then the clip is securely positioned, but releasing the capsule requires complex mechanisms increasing device complexity
Solution Approach 1:
The collet is pre-positioned over the distal portion of the catheter and automatically engages to compress and hold the capsule in place during delivery. The release is achieved by simply withdrawing the collet, which eliminates the need for complex active release mechanisms.
Solution Approach 2:
The capsule is extracted from the constrained environment of the catheter by withdrawing the collet. This simple extraction motion releases the capsule from the distal portion of the catheter without requiring complex release mechanisms, allowing the clip to be deployed into the target vessel.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system provides efficient deployment of clips with reduced length and minimized shed parts, enhancing visualization and maneuverability, particularly suitable for large defect cases like Peroral Endoscopic Myotomy and Endoscopic Submucosal Dissection.
Implementation Method 1
The distal and proximal portions of the yoke are connected to one another via a separable connection that is configured to separate when subject to a predetermined force exceeding a predetermined threshold value
Implementation Method 2
In the insertion configuration, the collet is positioned over the distal portion of the catheter to press the distal portion against the capsule and to hold the capsule therein
Implementation Method 3
a pair of clip arms, proximal ends of which are slidably received within the channel of the capsule to move the clip arms between an open configuration and a closed configuration
Data Source
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AI summary
A clipping system comprises a catheter, a clip, a collet, and a control member. The catheter extends longitudinally from a proximal end to a distal end and includes a channel extending therethrough. The catheter includes a plurality of longitudinal slots extending through a wall thereof from the distal end along a distal portion of the catheter. The clip includes a capsule extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, and a pair of clip arms, proximal ends of which are slidably received within the channel of the capsule to move the clip arms between an open configuration and a closed configuration. The capsule of the clip is configured to be releasably received within the distal portion of the catheter. The collet is slidably mounted over the catheter and movable between an insertion configuration and a deployed configuration. In the insertion configuration, the collet is positioned over the distal portion of the catheter to press the distal portion against the capsule and to hold the capsule therein. In the deployed configuration, the collet is proximal the distal portion so that the clip is releasably from the distal portion of the catheter. The control member is connected to the clip arms and the collet via a yoke. The yoke includes a distal portion connected to the clip arms and a proximal portion connected to a portion of the collet. The distal and proximal portions of the yoke are connected to one another via a separable connection that is configured to separate when subject to a predetermined force exceeding a predetermined threshold value.