Endoscopic Tissue Anchoring via Transmural Loop Formation
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Solution Overview
Problem
Endoscopic treatments for gastroesophageal reflux disease (GERD) face challenges in securing anchors to soft tissue, as traditional methods like screws, staples, and sutures tend to pull out over time, especially when a load is applied, limiting the effectiveness of mechanical barriers in preventing reflux.
Innovation Solution
An endosonography-guided method using an anchoring element with proximal and distal ends, inserted through the esophageal wall and diaphragmatic crus into the stomach fundus, forming a loop to secure tissues and prevent reflux by creating a mechanical barrier at the gastro-esophageal junction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional anchoring methods (screws, staples, sutures) are used to secure anchors to soft tissue, then the procedure can be performed with simple equipment, but the anchors tend to pull out over time especially when load is applied
Solution Approach 1:
The anchoring element is divided into multiple segments or cells that can expand independently. Each cell can be inflated or expanded sequentially to distribute the anchoring force across multiple tissue engagement points, preventing single-point failure and reducing pull-out risk while maintaining manageable device complexity through modular design
Solution Approach 2:
The anchoring element transitions from a compressed delivery state to an expanded deployed state. This dynamic transformation allows the anchor to adapt to tissue geometry and distribute forces dynamically, improving stability without requiring complex pre-configured structures that would increase device complexity
2Duration of action of stationary object
If anchors are secured to soft tissue walls of the stomach, then a mechanical barrier can be created to prevent reflux, but the anchors pull out and displace over weeks or months
Solution Approach 1:
The anchoring element is pre-configured with expansion cells or gripping structures that are activated upon deployment. This preliminary configuration ensures that the anchor engages tissue securely from the moment of deployment, preventing displacement over time without requiring complex multi-step securing procedures
Solution Approach 2:
The anchoring element changes physical parameters such as volume, shape, or surface area after deployment. This parameter change allows the anchor to lock into tissue or create friction-based retention, extending retention time while maintaining reliability through controlled transformation rather than complex mechanical interlocking
3Reliability
If an anchoring element is inserted through the esophageal wall and diaphragmatic crus into the stomach fundus, then a stable mechanical barrier is created, but the insertion procedure becomes more complex
Solution Approach 1:
The anchoring element is nested within a delivery catheter or sheath during insertion. This nesting allows the complex anchor structure to be compressed into a small profile for easy delivery through the esophageal wall and diaphragmatic crus, then expanded at the target site to create the stable mechanical barrier without requiring complex insertion maneuvers
Solution Approach 2:
A delivery catheter or sheath acts as an intermediary between the operator and the anchoring element during insertion. This intermediary simplifies the insertion procedure by providing a guided pathway and protective enclosure, allowing the anchor to be delivered through complex anatomical structures without requiring the operator to directly manipulate the complex anchor structure
Data Source
AI summary
The present invention relates to a tissue securement system, device and method for endoscopy or endosonography-guided transluminal interventions through which a ligation is placed and secured into tissue. An objective of this invention is to provide a stable securement platform for the coupling of secondary anchors to the gastrointestinal tract. Specifically, endoscopy is used to insert an anchoring element through the walls of adjacent body cavities. The ends of the anchoring element are coupled together to form a loop. This anchoring element can be used to secure other anchors or devices to the gastrointestinal tract.