Artificial Sphincter Delivery via Nested Catheter for GERD

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Solution Overview

Problem

Current surgical treatments for conditions like Gastro Esophageal Reflux Disease (GERD) are invasive and carry high risks, such as esophageal tears and persistent esophagitis, and do not effectively address the compromised functionality of the lower esophageal sphincter, leading to chronic acid reflux and esophageal damage.

Innovation Solution

An artificial sphincter apparatus is developed, comprising an annular body with radially extending anchors and a deployment mechanism, which can be inserted into the esophagus to engage the inner wall, providing a mechanical barrier to reflux and potentially promoting tissue ingrowth and healing, using biocompatible materials and therapeutic substances to enhance functionality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical procedures are used to treat GERD, then the sphincter functionality can be addressed, but the procedure is invasive and carries high risks such as esophageal tears and persistent esophagitis

Engineering Contradiction:
Improvesphincter functionalityVSAvoidinvasive risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an artificial sphincter device as an intermediary component that mechanically reinforces the lower esophageal sphincter without requiring direct surgical manipulation of the esophageal tissue. This mediator device provides the necessary structural support to prevent reflux while avoiding the harmful effects of invasive surgery on the esophagus

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The artificial sphincter is divided into multiple segments or components including an expandable frame structure with radial struts that can be independently deployed and adjusted. This segmentation allows for controlled installation and reduces the risk of complications during implantation

Inventive Principle:
Principle #1Segmentation

2Reliability

If traditional surgical procedures are used to treat GERD, then reflux symptoms can be addressed, but the procedure causes trauma and requires long recovery time

Engineering Contradiction:
Improvereflux controlVSAvoidrecovery time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces complex surgical mechanical procedures with a minimally invasive delivery system that uses controlled expansion mechanisms. The artificial sphincter is delivered through a catheter-based system and expanded in place using balloon inflation or self-expanding mechanisms, eliminating the need for extensive surgical dissection and reducing recovery time

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If an artificial sphincter is deployed, then reflux symptoms are reduced and tissue healing is promoted, but the device complexity increases

Engineering Contradiction:
Improvereflux reductionVSAvoidsphincter device structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The artificial sphincter employs a nested structure where the expandable frame is contained within a delivery catheter, which itself is inserted through the esophageal wall. The frame structure includes nested radial struts that can be sequentially deployed, allowing the complex device to be delivered through a minimally invasive approach while maintaining structural integrity during implantation

Inventive Principle:
Principle #7Nested doll (Nesting)

Data Source

PatentEP2957260B1Delivery device for an artificial sphincter
Publication Date: 2021.04.21 ETHICON INC
  • EP2957260B1 patent drawingFigure 1
  • EP2957260B1 patent drawingFigure 2
  • EP2957260B1 patent drawingFigure 3

AI summary

A surgical implant, delivery apparatus and method for insertion of the same into a biological lumen. The implant has an outer ring having an outer wall and an inner wall the outer ring disposed about a central axis. The implant further has an inner ring adjacent to the outer ring inner wall disposed about the central axis defining an annular opening. The implant has a valve flexibly attached to the inner ring and disposed about the central axis, the valve substantially occluding the annular opening in a first state and elastically opening to provide a variably sized bore in a second state to permit passage of a substance through the lumen.