Segmented GERD Movement Restriction Implant for Fundus Fixation
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Solution Overview
Problem
Existing surgical treatments for Gastroesophageal Reflux Disease (GERD) face challenges such as device migration, tissue damage, and complications like obstruction or ileus due to the fragile nature of the esophagus, necessitating a safer and more effective long-term treatment.
Innovation Solution
A movement restriction device designed to be implanted between the stomach fundus wall and diaphragm, disassembling into segments for easy implantation, with a biocompatible outer surface, and secured by sutures or staples to the stomach wall, reducing the risk of migration and tissue damage, and allowing passage through the gastrointestinal system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a device is implanted around the esophagus to treat GERD, then the cardia can be prevented from sliding into the thorax cavity, but the device may migrate through and damage the fragile esophageal tissue
Solution Approach 1:
The device is divided into multiple segments that can be separately implanted and positioned around the esophagus. This segmentation allows for more precise placement and reduces the risk of complete device migration, as individual segments can be secured independently to the surrounding tissue.
Solution Approach 2:
The device uses an intermediary mechanism (such as a mesh or porous structure) that allows tissue ingrowth between the device and the esophagus. This intermediary layer distributes mechanical stresses and prevents direct contact between the device surface and the fragile esophageal mucosa, reducing tissue damage while maintaining device stability.
2Reliability
If sutures are used to secure the device to the esophagus, then the device can be held in place, but the sutures will not hold over the long term due to the fragile esophageal tissue
Solution Approach 1:
The device is designed with preliminary fixation elements (such as barbs, hooks, or expansion mechanisms) that provide immediate mechanical anchoring upon implantation. This preliminary action secures the device before tissue healing occurs, preventing migration during the critical early period when sutures would otherwise fail.
Solution Approach 2:
The device incorporates dynamic elements that adapt to tissue changes over time. As the surrounding tissue heals and strengthens, the device can transition from relying on initial mechanical fixation to being secured by the healed tissue structure itself, extending the duration of effective fixation.
3Reliability
If a large device is used to effectively restrict stomach movement, then reflux prevention is improved, but the device cannot pass through a trocar for minimally invasive implantation
Solution Approach 1:
The device segments are designed to nest within each other during implantation, similar to nested dolls. This allows the complete device to be compressed into a small profile that can pass through a standard trocar, while still expanding to its full functional size once implanted to effectively restrict stomach movement and prevent reflux.
Solution Approach 2:
The device incorporates dynamic expansion mechanisms that allow it to transition from a compressed implantable state to a fully expanded functional state. During implantation, the device is delivered in a compact form through the trocar, then expands in situ to achieve the appropriate size for effective GERD treatment, combining ease of implantation with treatment efficacy.
Data Source
Figure 1A~1C
Figure 2A~2B
Figure 3A~3B
AI summary
A system for treating reflux disease in a human or animal mammal patient, wherein the system comprises: two or more separate movement restriction device segments (10), each movement restriction device segment being adapted to be invaginated by the stomach wall (12) and to in situ form an implantable movement restriction device, wherein the movement restriction device is adapted to be invaginated by and rest with at least a part of its outer surface against the patient's stomach fundus wall (16), in a position between the patient's diaphragm (18) and the fundus wall, and wherein the two or more separate movement restriction device segments are separable to individually pass through the intestinal system of the patient, if released from their invaginated position.