Expandable Anchor for Intestinal Bypass Sleeve
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Solution Overview
Problem
Current bariatric surgical procedures for obesity and related gastrointestinal conditions are invasive, carry significant risks, and require lengthy recovery periods, while existing minimally invasive implants face issues like tissue necrosis, bacterial infection, and migration due to their design and anchoring methods.
Innovation Solution
An endoscopically implantable intestinal bypass sleeve with a flexible thin-walled sleeve and an expandable anchor that can be inserted through the mouth, throat, stomach, and intestines, featuring secondary anchors and an optional active pumping mechanism to manage gastric emptying and reduce symptoms of gastroparesis by holding open the pylorus and actively pumping stomach contents into the duodenum.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional bariatric surgical procedures are used, then weight loss and treatment of gastrointestinal conditions are achieved, but the procedures are invasive, carry significant risks, and require lengthy recovery periods
Solution Approach 1:
The implant system is divided into separate components: a tubular sleeve for intestinal bypass and distinct anchoring barbs for securing the sleeve. This segmentation allows the sleeve to be delivered minimally invasively while the barbs provide secure anchoring, resolving the contradiction between safety and invasiveness by separating the functions of the implant components.
Solution Approach 2:
The anchoring barbs serve as an intermediary mechanism between the implantable sleeve and the surrounding tissue. Rather than requiring invasive surgical attachment, the barbs provide a intermediate anchoring solution that secures the sleeve minimally invasively, reducing surgical complexity while maintaining reliability.
2Stability of the object's composition
If stents with active fixation means such as barbs are used, then anchoring stability is improved, but tissue necrosis and erosion of implants through tissue may occur
Solution Approach 1:
The anchoring barbs are designed with specific local characteristics: they are positioned at discrete locations around the sleeve circumference and have controlled dimensions. This local quality approach provides sufficient anchoring stability at specific points without causing widespread tissue damage, resolving the contradiction between anchoring stability and tissue necrosis.
Solution Approach 2:
The barbs are designed with specific geometric parameters (length, thickness, spacing) that optimize the balance between anchoring force and tissue preservation. By carefully controlling these parameters, the barbs provide stable anchoring while minimizing the risk of tissue necrosis and erosion.
3Ease of operation
If implants such as stents are placed in the digestive tract, then intestinal bypass and gastric emptying management are achieved, but migration occurs due to intermittent peristaltic motion
Solution Approach 1:
The system merges the tubular sleeve and anchoring barbs into a single integrated implant unit. The barbs are attached to the sleeve, combining the gastric emptying management function of the sleeve with the anchoring function of the barbs. This merging prevents migration by ensuring the anchoring mechanism moves with the sleeve during peristalsis, resolving the contradiction between ease of operation and implant position stability.
Data Source
AI summary
A gastrointestinal device for implanting within a pylorus, a duodenal bulb, and a duodenum of a patient's gastrointestinal tract includes an expandable structure including a proximal portion having a plurality of spring arms and a distal portion having a plurality of spring arms, the proximal and distal portions coupled by a rigid central cylinder having a diameter capable of fitting within the pylorus and having a length greater than a width of the pylorus. An intestinal bypass sleeve is coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum. In the expanded configuration, the proximal portion has a diameter larger than a maximum opening diameter of the pylorus and further wherein, in the expanded configuration, the distal portion has a diameter larger than a maximum opening diameter of the pylorus.


