Repositionable Over-the-Scope Clip for Seeding-Safe Tissue Resection
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Solution Overview
Problem
Endoscopic procedures such as full thickness tissue resection and treatment of issues outside the GI tract increase the risk of intrabdominal hypertension and cancer cell seeding, and create tissue openings that need to be hemostatically sealed.
Innovation Solution
A clipping system with a disc-shaped clip mounted over an endoscope, featuring cut-outs to facilitate movement between open and closed configurations, and control members for precise positioning, combined with a membrane to trap clipped tissue, minimizing the risk of cancer seeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If full thickness tissue resection is performed to remove cancerous tissue, then cancer removal is improved, but cancer cell seeding risk increases
Solution Approach 1:
A membrane is introduced as an intermediary barrier between the resected tissue and the surrounding environment. The membrane is positioned to cover the tissue opening after resection, preventing direct contact between potential cancer cells and the surrounding tissue/fluids, thus eliminating the harmful effect while preserving the beneficial cancer removal
2Adaptability or versatility
If tissue openings are created during endoscopic procedures, then access to treat underlying issues is improved, but hemostatic sealing becomes more difficult
Solution Approach 1:
The membrane serves as an intermediary sealing element that fills the tissue opening created during endoscopic procedures. It provides hemostatic sealing by physically blocking the opening, preventing bleeding and fluid leakage, while still allowing the endoscope to access the underlying tissue for treatment
3Measurement precision
If clip is made repositionable for precise positioning, then positioning precision is improved, but device complexity increases
Solution Approach 1:
The clip is designed with dynamic repositioning capability through a control mechanism that allows it to be moved between different positions along the endoscope shaft. This dynamic adjustment enables precise positioning of the clip relative to the tissue target, improving positioning precision while the mechanism remains integrated into the existing endoscope structure
Data Source
AI summary
A clipping system includes a clip, extending and control members and an endcap mounted on an insertion device. A planar body of the clip includes first and second cut-outs defining fingers. The control members slide within extending members to releasably couple to the clip so that movement the control members moves the clip between an insertion configuration, an initial deployed configuration and a review configuration in which the end cap is withdrawn proximally away from the clip to enhance visual observation of the clip. The control member is operable to retract the clip proximally over the end cap toward the insertion configuration so that the fingers are forced open as the clip is retracted over the end cap, freeing the clip from tissue on which it had been clipped to reposition the clip if necessary.