UES Compression Device for Reflux Prevention
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Solution Overview
Problem
Current management and treatment strategies for gastroesophageal reflux complications, including aspiration of gastric contents into the lung and airway, are ineffective, leading to significant morbidity and healthcare burden, with existing pharmacologic and surgical therapies offering only modest improvements and temporary solutions.
Innovation Solution
A non-pharmacologic device that uses an intra-luminal pressure sensor and UES compression device to increase the Upper Esophageal Sphincter (UES) pressure externally, preventing gastric contents from entering the pharynx and lung by compressing the UES between the cricoid cartilage and cervical vertebrae, maintaining intra-luminal pressure within a predetermined range to prevent reflux during sleep.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmacologic therapy (proton pump inhibitors, H2 receptor antagonists) is used to suppress acid, then acid reflux symptoms are modestly improved, but the treatment does not provide significant improvement and requires long-term use
Solution Approach 1:
The patent replaces pharmacologic therapy with a mechanical device (UES compression device) that physically compresses the upper esophageal sphincter to prevent reflux. This mechanical approach substitutes chemical/pharmacologic intervention with a physical barrier mechanism, achieving reflux prevention without relying on acid suppression medications.
Solution Approach 2:
The UES compression device acts as an intermediary mechanical barrier between the esophagus and pharynx. By applying external compression to the UES region, the device creates a physical obstruction that prevents gastric contents from ascending, serving as a mediator that blocks the reflux pathway without altering acid chemistry.
2Reliability
If surgical procedures are performed to manage reflux, then some patients experience success, but the procedures have significant morbidity including difficulty swallowing, gas bloat syndrome, diarrhea, and weight loss
Solution Approach 1:
The invention segments the reflux prevention function from major surgical reconstruction. Instead of performing comprehensive anti-reflux surgery that affects gastric emptying and swallowing mechanics, the device isolates the UES compression function to a specific anatomical region, providing targeted reflux prevention without disrupting overall gastrointestinal physiology.
Solution Approach 2:
The UES compression device utilizes a flexible compression garment that applies distributed pressure through a soft, conforming structure. This flexible approach prevents the rigid mechanical disruption caused by surgical procedures while still achieving effective UES compression to block reflux.
3Reliability
If head of bed elevation or avoidance of eating before sleep is implemented, then acid suppressive therapy is combined with behavioral modifications, but these methods have not given rise to significant improvements
Solution Approach 1:
The UES compression device is designed for self-application by the patient without requiring medical intervention or complex setup. The patient can independently don the compression garment and adjust it to achieve effective UES compression, eliminating the need for provider-administered therapies or complex behavioral regimens.
Solution Approach 2:
The device is applied in advance before reflux episodes occur, particularly before sleep when nocturnal reflux is most problematic. By pre-compressing the UES before gastric contents can ascend, the device proactively prevents reflux rather than reacting to symptoms after they occur.
4Reliability
If surgical procedures are performed to manage reflux, then reflux is controlled, but the procedures do not last permanently and lose their efficacy within seven to ten years
Solution Approach 1:
The compression device employs dynamic, adjustable compression that can be modified over time to maintain effectiveness. Unlike static surgical repairs that become incompetent over time, the device allows for adjustment of compression levels and can be reapplied indefinitely, providing sustained reflux control without the fixed limitations of surgical anatomy changes.
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 prevents gastroesophageal reflux by maintaining UES pressure within a range that prevents aspiration, reducing symptoms and complications associated with reflux, such as chronic cough and respiratory disorders, and can be adjusted for individual patients to ensure safety and efficacy.
Implementation Method 1
an intra-luminal pressure sensor
Implementation Method 2
compressing the UES between the cricoid cartilage and cervical vertebrae, maintaining intra-luminal pressure within a predetermined range
Data Source
AI summary
An esophageal device is used to recognize, diagnose, characterize, or relieve an impact of an abnormal or defective UES anatomy, physiology, or functionality. In one implementation, the esophageal device measures a UES response to esophageal fluid infusion to detect or characterize an abnormality or defective UES anatomy, physiology, or functionality. An Upper Esophageal Sphincter compression device is used to increase intra-luminal pressure within the Upper Esophageal Sphincter of a patient in order relieve an impact of an abnormal or defective UES anatomy, physiology, or functionality.