Shape-Memory Alloy Transoral Valve Restoration Device

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Solution Overview

Problem

Current treatments for gastroesophageal reflux disease (GERD) are invasive and fail to restore the normal anatomical and functional gastroesophageal flap valve, leading to persistent reflux and complications such as esophagitis, dysphagia, and increased risk of esophageal adenocarcinoma.

Innovation Solution

A transoral gastroesophageal flap valve restoration device comprising a first member and a second member hingedly coupled to the first member, which is flexible for passage into the stomach and becomes rigid to form a gastroesophageal flap valve, allowing for the creation of a functional valve without damaging esophageal tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If the device is made rigid to form a gastroesophageal flap valve, then the valve formation capability is improved, but the ability to pass through the esophagus is worsened

Engineering Contradiction:

Improvevalve formation capabilityVSAvoidesophageal passage capability

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

The device employs a shape-memory alloy structure that can dynamically change its mechanical properties between flexible and rigid states. During esophageal passage, the device remains flexible to navigate the curved anatomy. Upon deployment in the stomach, thermal or mechanical activation triggers the shape-memory effect, transforming the device into a rigid structure capable of forming and maintaining the gastroesophageal flap valve geometry.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device utilizes changes in physical parameters (temperature, stress state) to transition between functional states. The shape-memory alloy's crystal structure transforms from austenite to martensite phases, altering stiffness and enabling the device to be inserted flexibly and then maintain a rigid valve-forming configuration after deployment.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If traditional surgical procedures are used to treat GERD, then the reflux control is improved, but the invasiveness and risk to esophageal tissue is worsened

Engineering Contradiction:

Improvereflux control effectivenessVSAvoidesophageal tissue damage risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces traditional mechanical surgical interventions (sutures, staplers, extensive dissection) with a minimally invasive endoscopic device. The shape-memory alloy device is delivered transorally through the esophagus without cutting or stapling, eliminating direct mechanical trauma to esophageal tissue while still achieving effective reflux control through flap valve restoration.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The shape-memory alloy device acts as an intermediary that restores the natural gastroesophageal flap valve function without requiring direct manipulation or damage to the esophageal mucosa. The device temporarily occupies the gastric space and uses its shape-memory properties to guide and support tissue remodeling, achieving reflux control while the esophagus remains intact.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If the device is made flexible for esophageal passage, then the ability to navigate the esophagus is improved, but the ability to maintain valve shape is worsened

Engineering Contradiction:

Improveesophageal navigation capabilityVSAvoidvalve shape maintenance

Core Design Contradiction:

Ease of operationVSStability of the object's composition

Solution Approach 1:

The device transitions from a dynamic flexible state during insertion to a static rigid state during valve formation. The shape-memory alloy's phase transformation enables this dynamic behavior, allowing the device to conform to the esophageal lumen during passage and then maintain a stable, predetermined three-dimensional configuration once deployed in the stomach.

Inventive Principle:

Principle #15Dynamics

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 restores the gastroesophageal flap valve, reducing reflux and associated complications, while being less invasive and minimizing risks to esophageal tissue, thus providing a more effective treatment for GERD.

Implementation Method 1

the device is comprised of a shape memory alloy which is selective to transform from a martensite phase to an austenite phase at a predetermined temperature

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 2

a first member, and a second member hingedly coupled to the first member

Methodology Applied

Scientific EffectHinge mechanism: Hinge

Data Source

PatentUS9526500B2Flexible transoral endoscopic gastroesophageal flap valve restoration device and method

Publication Date: 2016.12.27 MERIT MEDICAL SYSTEMS INC

AI summary

A transoral gastroesophageal flap valve restoration device has sufficient flexibility and dimension to be passed through the mouth, throat, and esophagus of a patient into the patient's stomach. The device includes a first member and a second member hingedly coupled to the first member. The first and second members are configured to flex in a direction to follow the esophageal path into the stomach and to be substantially rigid when forming the restored gastroesophageal flap valve.