Hemostasis Clip Connector Locking for Two-Stage Deployment
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Solution Overview
Problem
Endoscopic procedures for gastrointestinal tract treatment face challenges with hemostasis clips, including potential perforation risks and the need for multiple clips, which can result in shed parts getting trapped in larger defects.
Innovation Solution
A clipping device with a capsule and slidable clip arms, controlled by a connector and control member, allows for precise tissue clipping and deployment, minimizing shed parts by locking the clip in a closed configuration and facilitating its removal from the body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple clips are used to close larger defects, then closure effectiveness is improved, but the risk of shed parts getting trapped in defects increases
Solution Approach 1:
The clip is divided into two functional parts: a deployable closure component that performs the clamping action, and a retained anchor component that remains attached to the delivery device. This segmentation allows the closure function to be performed while preventing shed parts from being trapped, as the anchor provides a secure attachment point for the deployed clip.
2Measurement precision
If a two-stage deployment mechanism is implemented, then control precision is improved, but device complexity increases
Solution Approach 1:
The deployment mechanism transitions from a static single-stage system to a dynamic two-stage system. The first stage deploys the clip arms to engage tissue, and the second stage secures the clip in the closed position. This dynamic progression allows precise control over the clipping process while managing complexity through sequential activation of functional components.
Solution Approach 2:
The clip arms are pre-positioned and prepared in the first stage of deployment, allowing the tissue to be engaged before final securing. This preliminary action enables controlled deployment where the clip is first opened to receive tissue, then closed to secure it, improving precision while organizing complexity into manageable sequential steps.
3Reliability
If the clip is locked in closed configuration, then closure reliability is improved, but maneuverability during deployment is reduced
Solution Approach 1:
The clip mechanism transitions dynamically between open and closed configurations. During deployment, the clip arms are held in an open configuration allowing easy maneuverability and tissue engagement. Once positioned, the mechanism locks into a closed configuration to provide reliable closure. This dynamic state change resolves the contradiction by providing both maneuverability and reliability at appropriate times in the procedure.
Data Source
AI summary
A clipping device includes a clip including a capsule and a pair of clip arms, proximal ends of which are slidably received within the channel to move the clip arms between an open configuration and a closed configuration. Each of the pair of clip arms includes an elongated opening extending through the proximal ends thereof. A connector includes a central portion received between the proximal ends of the clip arms and a pin extending from the central portion receivable within the opening of each of the clip arms, the connector movable from an unlocked configuration, in which the pin is received within a distal portion of the elongated opening, to a locked configuration, in which the pin is received within a proximal portion of the elongated opening, when a predetermined force is applied thereto.