Endoscopic Tissue Plication Device with Movable Jaws
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Solution Overview
Problem
Current bariatric surgical procedures for metabolic disease, such as gastric bypass and gastric banding, are invasive and costly, and endoscopic plication devices face limitations in plication size and depth due to rigid device geometry and limited access within the gastric cavity.
Innovation Solution
A tissue acquisition and fixation system with movable jaws and a tissue acquisition member that can adjust its position relative to the jaws, allowing for the creation and securement of serosa-to-serosa tissue folds within the gastric lumen, using a staple applying assembly with a stapler portion and firing linkage to apply staples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If endoscopic plication devices are used to reduce gastric cavity volume, then the procedure becomes less invasive, but the plication size and depth are limited due to rigid device geometry and size restrictions
Solution Approach 1:
The device incorporates a flexible delivery catheter that can be advanced through the esophagus into the stomach, allowing the plication device to reach positions that would be inaccessible to rigid endoscopic devices. The flexible catheter enables dynamic navigation through the gastric cavity while maintaining the ability to deliver substantial plication forces.
Solution Approach 2:
The invention transitions from traditional endoscopic approaches (constrained by the oral route and rigid geometry) to a transgastric approach using a flexible delivery system. This dimensional change allows the device to access the gastric cavity from within, enabling larger plication depths without increasing external device size.
2Productivity
If larger plications are formed to reduce gastric volume more effectively, then treatment efficacy improves, but device complexity and difficulty of passage through the esophagus increase
Solution Approach 1:
The device is divided into distinct functional modules: a flexible delivery catheter for navigation, a plication device for tissue manipulation, and a stapling mechanism for securing the plication. This segmentation allows each component to be optimized independently, enabling large plication formation while maintaining passageability through the esophagus.
Solution Approach 2:
The delivery catheter is constructed as a flexible structure that can navigate the tortuous path of the esophagus and stomach. This flexibility allows the device to pass through narrow passages while still delivering the capability to form large plications once positioned within the gastric cavity.
3Device complexity
If traditional opposing jaws and grasper elements are used to draw tissue, then the device structure is simplified, but the plication size is limited to approximately the length of the jaws
Solution Approach 1:
The invention introduces a tissue acquisition member as an intermediary component between the grasper and the opposing jaws. This member can be positioned beyond the jaws to engage and draw additional tissue into the plication zone, effectively extending the plication length beyond the physical constraints of the jaw assembly.
Solution Approach 2:
The tissue acquisition member is used to pre-position and draw tissue into the desired configuration before the stapling action occurs. This preliminary tissue manipulation allows for larger plication sizes to be achieved without requiring the jaws themselves to be larger or more complex.
Data Source
AI summary
Devices and methods are provided for forming and securing a tissue plication. More particularly, the devices and methods of the present invention can be used to create multiple tissue folds on an anterior and posterior wall of a stomach cavity to reduce the volume thereof. In one aspect, a method of gastric volume reduction is disclosed that includes advancing a tissue acquisition and fixation device endoscopically into a stomach, manipulating the device to form a first fold of tissue on an interior surface of an anterior wall of the stomach, and manipulating the device to form a second fold of tissue on an interior surface of a posterior wall of the stomach, where the second fold is not attached to the first fold.