Two-Stage Hemostasis Clip Locking for Shed-Part-Free Closure
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Solution Overview
Problem
Endoscopic procedures face challenges in effectively closing gastrointestinal tract perforations and treating defects or bleeds due to the risk of perforation and the need for multiple clips, which can result in shed parts becoming trapped in larger defects.
Innovation Solution
A clipping device with a clip mechanism that includes a capsule and slidable clip arms, controlled by a connector and control member, allowing for precise closure and deployment of the clip over target tissue, minimizing shed parts by locking the clip arms relative to the capsule.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple clips are used to close larger defects, then the closure effectiveness is improved, but the risk of shed parts becoming trapped in the defect increases
Solution Approach 1:
The clip is divided into two separate components: the capsule (delivery device) and the clip arms (functional element). This segmentation allows the clip arms to be deployed independently from the capsule, ensuring that no shed parts from the capsule can become trapped in the defect. The capsule can be safely withdrawn after deployment while the clip arms remain in place to close the defect.
Solution Approach 2:
The clip arms are extracted from the capsule through a deployment mechanism where the clip arms are pushed out of the capsule by a pushing member. This extraction separates the functional closing element from the delivery system, allowing the capsule to be removed without leaving any parts trapped in the defect.
2Reliability
If a two-stage deployment mechanism is used to eliminate shed parts, then the safety is improved, but the device complexity increases
Solution Approach 1:
The clip arms are nested within the capsule in a compact configuration during delivery. The proximal ends of the clip arms are received within the capsule, and the distal ends are positioned to be deployable from the capsule. This nested arrangement allows the complex two-stage deployment mechanism to be packaged in a simple, deliverable form through the endoscope working channel.
Solution Approach 2:
A pushing member acts as an intermediary component that transfers force from the operator to the clip arms during deployment. The pushing member engages with the clip arms and pushes them out of the capsule, enabling the two-stage deployment without requiring complex mechanical mechanisms. The intermediary pushing member simplifies the overall system while achieving safe deployment.
3Manufacturing precision
If the clip arms are locked relative to the capsule, then the precision of closure is improved, but the maneuverability during deployment is reduced
Solution Approach 1:
The connection between the clip arms and capsule transitions from a static locked state to a dynamic deployable state. During deployment, the clip arms can move relative to the capsule as they are pushed out. After deployment, the locking mechanism engages to provide precise, stable closure. This dynamic behavior allows both maneuverability during deployment and precision during closure.
Solution Approach 2:
The locking mechanism is designed to engage automatically after deployment, performing the locking action preliminarily before final closure is achieved. This preliminary locking ensures precision is established early in the closure process, while the deployment phase maintains maneuverability through the push-out mechanism.
Data Source
Figure 1A
Figure 1B~2
Figure 3~4
AI summary
The present invention discloses a clipping device, comprising: a clip including 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 to move the clip arms between an open configuration and a closed configuration, each of the pair of clip arms including an opening extending through the proximal ends thereof; a connector including a central portion receivable 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, at least a portion of the central portion configured to be movable relative to the pin and the clip arms from an unlocked configuration to a locked configuration, when a predetermined force is applied thereto; and a control member extending through a proximal portion of the clipping device from a proximal end to a distal end releasably coupled to the connector so that a longitudinal movement of the control member relative to the capsule moves the clip between the open and the closed configurations, when the connector is in unlocked configuration.