Endoscopic Sleeve Device for Gastrointestinal Bypass
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Solution Overview
Problem
Current methods for treating obesity and metabolic diseases, such as Roux-en-Y gastric bypass surgery, are invasive and carry risks of malnutrition and micronutrient deficiencies, and there is a need for less invasive techniques that can effectively reduce weight and improve diabetes control.
Innovation Solution
The development of endoscopic devices and methods for bypassing portions of the gastrointestinal tract using a sleeve device deployment system, which includes a proximal and distal stent and a tube, that can be deployed and anchored within the GI tract to reduce nutritional uptake, allowing for direct visualization and deep positioning, thereby mimicking the physiology of RYGB without the need for open or laparoscopic surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional Roux-en-Y gastric bypass surgery is performed, then weight loss and diabetes control are achieved, but the risk of malnutrition and micronutrient deficiencies increases
Solution Approach 1:
The gastrointestinal tract is segmented into functional zones using multiple stents positioned at different locations. The first stent is positioned in the duodenum and the second stent in the jejunum, creating distinct bypass segments that allow selective nutritional management while maintaining adequate nutrient absorption pathways.
Solution Approach 2:
The stent diameters are varied along the gastrointestinal tract to control flow dynamics and nutrient absorption. The delivery system transitions from a low-profile configuration during insertion to an expanded configuration at the target site, allowing precise control over the bypass geometry and nutritional uptake parameters.
2Reliability
If invasive bariatric surgery is performed, then weight loss and diabetes control are achieved, but the invasiveness and surgical risks increase
Solution Approach 1:
The invasive surgical mechanical system is replaced with an endoscopic delivery system that uses a flexible delivery catheter and balloon expansion mechanism. The stents are delivered endoscopically through the gastrointestinal lumen and expanded using balloon inflation, eliminating the need for open or laparoscopic surgery.
Solution Approach 2:
The stent structure is nested within the delivery catheter in a compressed low-profile configuration. The first stent and second stent are sequentially deployed from the same delivery system, with each stent nested within the catheter lumen during delivery and then expanded at the target location.
3Reliability
If deep positioning within the small intestines is required, then effective bypass is achieved, but the difficulty of device delivery and visualization increases
Solution Approach 1:
The stent structure incorporates radiopaque markers and contrast-enhancing features that allow visualization under fluoroscopic guidance. The stent material or coating changes its radiographic properties when expanded, enabling clear detection of stent deployment and positioning deep within the small intestine.
Solution Approach 2:
The delivery catheter acts as an intermediary tool that facilitates deep positioning of the stents within the small intestine. The catheter provides a guided pathway and supports the stents during delivery, enabling precise placement at target locations that would otherwise be difficult to reach and visualize.
Data Source
AI summary
Devices and methods can be used for the endoscopic treatment of conditions such as obesity and metabolic diseases. For example, this document provides devices and methods for bypassing portions of the gastrointestinal tract to reduce nutritional uptake. The devices provided herein can be endoscopically implanted such that direct visualization of the entire implant location within the gastrointestinal tract is attained. In some embodiments, the device is distally deployed utilizing a technique that is like that of single or double-balloon enteroscopy.