Slitted Tissue Fastener for Minimally Invasive GERD Repair
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Solution Overview
Problem
Current surgical and transoral endoscopic procedures for treating gastroesophageal reflux disease (GERD) are invasive and fail to restore the normal anatomical anatomy of the gastroesophageal junction, often requiring multiple fasteners and being difficult to maneuver in confined spaces, with a risk of tissue trauma and complications such as fistulas.
Innovation Solution
A fastener assembly comprising a first and second member with a connecting member and a through channel, allowing for sliding receipt of a tissue piercing deployment wire, and a slit for early deployment with reduced tissue compression, facilitated by a pusher to minimize trauma and ensure secure fixation of tissue layers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current surgical and transoral endoscopic procedures are used to treat GERD, then tissue fixation can be achieved, but the procedures are invasive and fail to restore normal anatomical anatomy
Solution Approach 1:
The fastener members are designed as thin, flexible structures that can conform to tissue surfaces and be deployed minimally invasively. The first and second members are thin film-like structures that can be inserted through small openings and deployed to secure tissue without requiring large incisions or extensive surgical exposure.
2Reliability
If multiple fasteners are used to secure tissue layers, then fixation security is improved, but device complexity and difficulty of maneuvering in confined spaces increases
Solution Approach 1:
The invention combines multiple fastening functions into a single integrated assembly. The first and second members work together as a coordinated unit, with the connecting member linking them, allowing simultaneous engagement of multiple tissue layers without requiring separate fasteners for each layer.
Solution Approach 2:
The fastener assembly is designed to perform multiple functions: the first member engages one tissue layer, the second member engages another layer, and the connecting member provides structural linkage. This multi-functional design eliminates the need for multiple separate fasteners while maintaining secure fixation of complex tissue structures.
3Reliability
If traditional fasteners are deployed in confined spaces, then tissue fixation can be achieved, but maneuvering difficulty and risk of tissue trauma increases
Solution Approach 1:
The fastener is divided into distinct segments: the first member, the second member, and the connecting member. This segmentation allows each component to be independently manipulated and deployed through narrow access channels, with the tissue piercing deployment wire guiding the entire assembly through confined spaces before deployment.
Solution Approach 2:
The tissue piercing deployment wire acts as an intermediary that guides the fastener assembly through confined anatomical spaces to the deployment site. The wire provides a pathway through which the entire fastener can be delivered minimally invasively, reducing the need for complex maneuvering of the fastener itself in difficult-to-reach areas.
4Reliability
If tissue compression is applied during fastener deployment, then secure fixation is achieved, but tissue trauma and risk of complications such as fistulas increases
Solution Approach 1:
The fastener members are pre-formed with the appropriate geometry and structural characteristics needed to provide secure fixation upon deployment. The first and second members are manufactured with features that enable them to engage tissue effectively once deployed, eliminating the need for excessive compression forces during the deployment process.
Data Source
AI summary
Tissue fasteners carried on a tissue piercing deployment wire fasten tissue layers of a mammalian body together include a first member, a second member, and a connecting member extending between the first and second members. One of the first and second members has a configuration alterable by a deployment wire to permit release of the fastener from the deployment wire after deployment and without causing excessive tissue trauma.