GERD Implantable Restriction Device for Reflux and Tissue Protection
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Solution Overview
Problem
Existing treatments for gastroesophageal reflux disease (GERD), such as Nissen fundoplication and the Anglechik prosthesis, risk damaging the esophagus and can cause complications like constriction of the food passageway or migration, and mechanical interaction with tissue leads to tissue deterioration and necrosis.
Innovation Solution
An implantable movement restriction device and electrode arrangement are used to restrict the movement of the cardia towards the diaphragm, with the electrode stimulating muscle tissue to improve long-term implantation, and a variable-length core encircling the esophagus to allow food passage while preventing reflux.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the fundus is wrapped around the lower esophageal sphincter to strengthen the sphincter and prevent acid reflux, then the effectiveness of preventing reflux is improved, but the food passageway becomes constricted making it more difficult to swallow
Solution Approach 1:
The fundus is divided into multiple wraps around the LES, with each wrap providing partial support and reflux prevention while maintaining patency of the food passageway. The segmented approach distributes the constriction force rather than creating a single tight band
Solution Approach 2:
The fundoplication wrap is designed to be dynamic, allowing the fundus to move and adapt during swallowing. The wrap can relax during peristalsis to maintain food passage while providing restraint during reflux episodes
2Reliability
If a medical implant is placed around the esophagus to prevent cardia migration, then the effectiveness of preventing sliding is improved, but the implant causes tissue deterioration, atrophy and necrosis due to long-term mechanical interaction
Solution Approach 1:
The patent replaces purely mechanical implant support with a combination of biological tissue integration and controlled mechanical support. The implant works through tissue ingrowth and biological fixation rather than purely mechanical anchoring, reducing localized stress and tissue damage
Solution Approach 2:
The implant design incorporates parameters that change over time, such as gradual tissue ingrowth, adaptive compliance, and evolving mechanical properties. The implant transitions from initial mechanical support to long-term biological integration, reducing harmful mechanical interactions
3Reliability
If the implant is designed to restrict movement of the cardia towards the diaphragm, then the effectiveness of preventing sliding into the thorax is improved, but the device may constrict the food passageway
Solution Approach 1:
The implant provides localized support specifically at the gastroesophageal junction and cardia region, where movement restriction is needed, while leaving the rest of the esophageal lumen open for food passage. The support is concentrated at the critical anti-reflux point rather than uniformly distributed
Solution Approach 2:
The implant restricts movement in the vertical dimension (preventing cardia sliding into the thorax) while maintaining patency in the horizontal dimension (food passage). The device operates in different spatial dimensions to simultaneously achieve restraint and patency
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 prevents reflux without constricting the food passageway and reduces tissue damage by stimulating muscle tissue to enhance implant tolerance, allowing for a more durable and less invasive treatment of GERD.
Implementation Method 1
The electrode arrangement is configured to be arranged between the movement restriction device and the fundus wall portion and to engage and electrically stimulate muscle tissue of the fundus wall portion to exercise the muscle tissue
Data Source
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.