Implantable GERD Device with Electrical Stimulation

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Solution Overview

Problem

Current treatments for gastroesophageal reflux disease (GERD), such as Nissen fundoplication and Anglechik prosthesis, are associated with complications like constriction of the food passageway, migration, and tissue damage due to mechanical interaction and foreign body reaction, leading to inefficient and damaging outcomes.

Innovation Solution

An implantable movement restriction device and electrode arrangement are designed to be placed between the diaphragm and the stomach's fundus wall, restricting cardia movement and electrically stimulating muscle tissue to improve long-term implantation, with a variable elongated core and tubular cover that constricts fluid flow while allowing food passage, and an electrode arrangement to promote tissue exercise and integration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If Nissen fundoplication surgery is performed to strengthen the sphincter and prevent acid reflux, then reflux prevention is improved, but the food passageway becomes constricted making swallowing difficult

Engineering Contradiction:

Improvereflux preventionVSAvoidswallowing ability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent employs a flexible implantable device that can dynamically adjust its configuration. The device includes a fundoplication element that can be positioned to support the LES without creating rigid constriction, allowing it to flex and accommodate during swallowing while maintaining reflux barrier function.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The implantable device is designed with dynamic characteristics, allowing it to change its mechanical properties or position in response to physiological conditions. This enables the device to provide strong support during reflux events while becoming more compliant during normal swallowing, thus resolving the contradiction between reflux prevention and swallowing ease.

Inventive Principle:

Principle #15Dynamics

2Stability of the object's composition

If the Anglechik prosthesis is placed around the esophagus to prevent cardia migration, then cardia stability is improved, but the device migrates and damages the esophagus

Engineering Contradiction:

Improvecardia stabilityVSAvoiddevice stability

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The patent introduces an intermediary attachment mechanism that mediates between the implant and the stomach tissue. This intermediary layer distributes mechanical stresses and allows for controlled movement, preventing both device migration and tissue damage while maintaining cardia stability.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The device incorporates cushioning elements or compliant structures that are designed to absorb and distribute mechanical forces before they can cause tissue damage. This beforehand cushioning prevents the harmful effects of device-tissue interaction while maintaining the intended stabilizing function.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If an implant is placed in the body to treat GERD, then treatment effectiveness is improved, but the implant causes tissue deterioration, atrophy and necrosis due to long-term mechanical interaction

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidtissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates electrical stimulation capability to supplement or replace purely mechanical support functions. By using electrical signals to stimulate muscle activity, the device can maintain tissue health and function without relying solely on mechanical contact, thereby reducing mechanical-induced tissue damage.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The device includes features that promote tissue health and integration over time. Electrical stimulation capabilities encourage muscle activity and tissue vitality, while the design facilitates beneficial tissue growth patterns that secure the device and improve long-term outcomes, creating a self-reinforcing system.

Inventive Principle:

Principle #25Self-service

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 solution effectively restricts reflux without constricting the food passageway, reduces tissue damage, and enhances the body's acceptance of the implant by exercising the muscle tissue, providing a more efficient and less damaging treatment for GERD.

Implementation Method 1

The electrode arrangement is configured to be arranged between the movement restriction device and the fundus wall portion and to electrically stimulate muscle tissue of the fundus wall portion to exercise the muscle tissue

Methodology Applied

Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentUS20230062862A1Treatment of gerd

Publication Date: 2023.03.02 FORSELL PETER

AI summary

The present disclosure relates to treatment of reflux disease of a human patient. More particularly, a device is disclosed, which is configured to be implanted in the body of the human to restrict movement of the cardia of the patient's stomach towards the diaphragm opening into the patient's thorax, and/or to prevent stomach contents from passing from the stomach into the esophagus.