Tissue Fold Fastening at the GE Junction for GERD Repair
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Solution Overview
Problem
Gastroesophageal reflux disease (GERD) is caused by a deteriorated gastroesophageal flap valve allowing stomach contents to splash into the esophageal tract, resulting in a shortened esophageal tract and enlarged stomach, which existing treatments have not effectively addressed.
Innovation Solution
A device with tissue displacing elements and a tissue shaper is used to reshape stomach tissue, forming a fold at the esophageal-stomach junction, and includes a common retractor to lengthen the fold, vacuum orifices for stabilization, and a fastener applier to secure the fold, enhancing the gastroesophageal flap valve's functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing treatments are used for GERD, then the disease symptoms are addressed, but the shortened esophageal tract and enlarged stomach are not effectively corrected
Solution Approach 1:
The treatment approach is segmented into distinct functional components: tissue displacing elements for creating the fold, a tissue shaper for molding the tissue into the desired configuration, and a fastener applier for securing the fold. This segmentation allows each component to address specific aspects of the anatomical correction, thereby effectively treating GERD while also correcting the shortened esophageal tract and enlarged stomach.
Solution Approach 2:
The invention introduces a new dimension of treatment by creating a three-dimensional tissue fold at the gastroesophageal junction. This fold is formed by displacing tissue in multiple directions using the tissue displacing elements and shaping it with the tissue shaper, thereby restoring the anatomical structure in a way that existing two-dimensional or pharmacological treatments cannot achieve.
2Reliability
If tissue is displaced and shaped to form a fold, then the gastroesophageal flap valve functionality is restored, but the device complexity increases
Solution Approach 1:
Multiple functional components are merged into a single integrated device assembly. The tissue displacing elements, tissue shaper, and fastener applier are combined in one device that can be delivered through the esophagus and deployed at the gastroesophageal junction. This merging reduces the need for multiple separate procedures or devices while achieving the complex goal of restoring flap valve functionality.
Solution Approach 2:
The device is designed with multi-functionality to perform several tasks: the tissue displacing elements create the fold, the tissue shaper molds the tissue into the desired configuration, and the fastener applier secures the fold. This universality allows a single device to address all aspects of flap valve restoration without requiring multiple specialized devices, thereby managing complexity while achieving reliable functionality restoration.
3Manufacturing precision
If multiple tissue displacing elements are used to form the fold, then the tissue manipulation precision is improved, but the ease of operation decreases
Solution Approach 1:
The tissue displacing elements are designed to be individually movable, allowing dynamic adjustment during the procedure. Each element can be independently positioned and adjusted to achieve the precise tissue fold configuration needed. This dynamic capability enables high precision in fold formation while maintaining operational flexibility, as the elements can be adjusted in real-time based on tissue response and procedural needs.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively recreates a functional gastroesophageal flap valve, reducing reflux by securing the stomach and esophageal tract junction, thereby alleviating GERD symptoms.
Implementation Method 1
The device may also include a vacuum orifice configured to adhere the shaft to tissue. The vacuum orifice may be used to grasp the esophageal tract.
Data Source
AI summary
A tissue displacing and fastening device is provided for manipulating and fastening tissue together. The device includes a tissue displacing elements, which displaces tissue. A fold is formed from the displaced tissue and the tissue is fastened together to secure the fold.