Reverse Anastomosis Clip Closure for Distal Tissue Punctures
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Solution Overview
Problem
Existing endoscopic procedures face challenges in closing tissue perforations or punctures in non-adherent structures without surgical intervention, particularly when lumen-apposing metal stents are removed prematurely, risking leakage.
Innovation Solution
A reverse anastomosis clipping system with a clip having movable arms and a control mechanism that allows for endoscopic closure of tissue defects from the far side, using a barrel member and longitudinal member to transition between open and closed configurations, and a releasable connection to secure the clip in place.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a lumen-apposing metal stent is used to create an anastomotic conduit between two lumens, then access between structures is provided for EUS-guided drainage, but if the stent is removed or shifts early, there is a risk of leakage requiring surgical intervention
Solution Approach 1:
The patent applies preliminary action by deploying a closure clip system that proactively seals the puncture site before stent removal or potential displacement. The clip is positioned and activated in advance to create a secure closure, preventing leakage before it can occur. This anticipatory measure ensures that even if the stent is removed or shifts, the puncture site remains sealed.
Solution Approach 2:
The patent applies inversion by closing the puncture site from the far side (distal side) rather than from the proximal side. The closure clip is deployed through the stent lumen from the distal structure, grasping and sealing the tissue at the puncture site from within the distal lumen. This reverse approach allows effective closure without requiring access from the proximal side and eliminates the need for surgical intervention.
2Productivity
If LAMs are used with non-adherent structures, then access is provided, but time is required to create a permanent fistula and there is risk of leakage if removed early
Solution Approach 1:
The closure clip system performs preliminary action by sealing the puncture site before stent removal. The clip is deployed and activated in advance to create a permanent seal, ensuring that the puncture site remains closed even after stent removal. This preliminary closure action eliminates the waiting period required for permanent fistula creation and prevents leakage risk.
3Ease of operation
If there is no endoscopic methodology to close an opening in a far structure, then surgical intervention is required, but surgical intervention increases invasiveness and complexity
Solution Approach 1:
The patent applies inversion by performing the closure procedure from the far side (distal side) through the stent lumen rather than requiring proximal access or surgical intervention. The closure clip is delivered through the existing stent pathway, grasps the tissue at the puncture site from within the distal lumen, and secures the closure endoscopically. This reverse approach simplifies the procedure by utilizing the existing access pathway and eliminates the need for additional surgical incisions or complex surgical techniques.
Solution Approach 2:
The patent uses the stent lumen as an intermediary pathway to deliver the closure clip system to the puncture site. The stent serves as a guide and delivery channel, allowing the closure clip to be advanced through the stent lumen to the target site. This intermediary approach enables endoscopic closure without requiring direct surgical access to the puncture site, reducing invasiveness and procedural complexity.
Data Source
AI summary
A system includes a clip, a member and a control member. The clip includes a barrel member defines a cavity therein and clip arms. Distal ends of the arms are connected to one another and slidably received within the cavity to be moved between open and closed configurations. The member includes a lumen extending longitudinally therethrough. A distal end of the member in contact with the distal ends of the arms to hold the arms distally against the barrel member. The control member is slidably received within the lumen so that a distal end of the control member extends distally past the distal end of the member and the distal ends of the arms to be connected to the distal end of the barrel member. A longitudinal movement of the control member relative to the longitudinal member moves the arms between the open and closed configurations.