Self-Expanding Anastomotic Stent with Expandable Flanges
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Solution Overview
Problem
Current medical procedures for forming anastomoses, such as in gastric bypass surgery, face challenges like fluid leakage and stricture formation due to the variability in stapling and the need for precise placement of tissue anchors or stents.
Innovation Solution
The development of improved stents with a woven filament braid design, featuring expandable flanges and a cylindrical region with an open interior passage, along with laparoscopic and endoscopic tools for precise delivery and deployment, to facilitate the formation of leak-free and consistently sized anastomoses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional stapling methods are used to form anastomoses, then the procedure can be performed with standard surgical equipment, but fluid leakage and stricture formation occur due to variability in stapling and imprecise placement
Solution Approach 1:
The stent is designed with specific geometric parameters including a cylindrical region with diameter of 15-30mm and length of 20-40mm, with expandable flanges that can be adjusted to precise dimensions. This standardization of parameters ensures consistent anastomosis sizing and placement, eliminating the variability inherent in traditional stapling methods while maintaining reliability through controlled expansion to predetermined sizes
Solution Approach 2:
The invention replaces the mechanical stapling system with a self-expanding stent delivery system. The stent is delivered in a compressed state through a catheter and then expanded using radial force, substituting the complex mechanical stapling mechanism with a simpler expansion mechanism that provides more consistent results and better control over anastomosis formation
2Reliability
If tissue anchors or stents are used to secure adjacent lumens, then precise placement is required to avoid leakage, but the complexity of the procedure increases
Solution Approach 1:
The stent is nested within a delivery catheter in a compressed state, allowing it to be delivered through a minimally invasive approach. The stent contains expandable flanges that are nested within the catheter until deployment, reducing the complexity of the delivery system while ensuring precise placement and seal integrity through the controlled expansion mechanism
Solution Approach 2:
The stent is divided into functional segments including a cylindrical region and expandable flanges at each end. This segmentation allows each component to perform its specific function - the cylindrical region provides the main conduit while the flanges provide sealing and anchoring - reducing overall device complexity while maintaining high reliability
3Object-affected harmful factors
If the stent is deployed to ensure leak-free anastomosis, then fluid leakage is prevented, but the stent must be designed with complex expandable flanges
Solution Approach 1:
The stent employs local quality by providing expandable flanges only at the ends of the cylindrical region where sealing is required, rather than making the entire stent complex. The flanges are designed with specific local geometry to engage with tissue walls and prevent fluid leakage, while the main body remains a simple cylindrical conduit, thus preventing leakage without requiring complex structure throughout
Data Source
AI summary
Devices and methods for deploying an anastomotic stent between portions of the gastro-intestinal (GI) tract are disclosed. The anastomotic stents are configured to atraumatically engage the tissue walls and to permit the flow of fluid, partially digested food, and food. The stents can be deployed using endoscopic catheter devices, laparoscopic tools, and combinations of both endoscopic tools and laparoscopic tools. Examples of anastomoses include anastomoses between the stomach and a portion of the intestines such as the jejunum. Anastomoses can also be formed between two closed ends of the intestines, such as two closed ends of the colon formed during a colon resection procedure. Anastomoses can also be formed between a fundal pouch formed during a gastric bypass procedure and the jejunum. Laparoscopic tools are disclosed to deploy a stent by selectively removing a radial restraint on a self expanding stent with the restraint removed through the laparoscopic access points.