Compression device and pressure sensor for treatment of abnormal upper esophageal sphincter functionality
Inventors
Maris, Nick T. • Miller, James S. • Shaker, Reza • Bachman, Timothy • Schlueter, Nathan • Maloney, Eugene Paul • North, Eric David • Raine, Paul • Alex, Peter
Assignees
Respiratory Technology Corp • Medical College of Wisconsin
Publication Number
US-11819186-B2
Publication Date
2023-11-21
Expiration Date
2034-05-15
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Abstract
A 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 upper esophageal sphincter anatomy, physiology, or functionality. In one implementation, the compression device is used in conjunction with an external pressure sensing device to determine the external pressure that is to be applied to the cricoid for a specific patient. The compression device can be a means for the management and/or treatment of abnormal upper esophageal sphincter functionality, or a means for strengthening an esophageal sphincter of a subject, or a means for curing esophageal reflux disease of a subject, or a means for improving vocal function in a subject, or a means for managing lung aspiration, or a means for applying cricoid pressure during anesthesia intubation, or a means for stabilizing body structures such as during medical imaging or radiation treatment.
Core Innovation
The present invention provides a compression device designed to increase intra-luminal pressure within the upper esophageal sphincter (UES) of a patient in order to manage, treat, and potentially cure complications associated with abnormal UES functionality. This device employs a frame, an adjustable strap, and a cushion positioned to apply a predetermined and controlled pressure to the cricoid cartilage, thereby elevating the intra-luminal pressure of the UES to prevent gastroesophageal and gastroesophagopharyngeal reflux, particularly during sleep when the natural pressure barrier may be compromised.
To address the need for individualized and safe application of pressure, the invention also encompasses a pressure sensing device. This device includes a pouch containing a spacing insert and fluid, a conduit, a pressure sensor, a display, and a controller. Used in conjunction with the compression device, it determines and indicates the optimal external pressure that should be applied for each patient, ensuring efficacy while allowing for physiological events such as swallowing or belching.
The invention aims to solve the problem of insufficient and often problematic existing treatments for reflux and aspiration due to UES incompetency. Existing therapies such as medication and surgery are described as modestly effective at best, costly, and/or associated with significant risks and complications. By offering a non-pharmacologic, non-invasive means of raising UES pressure through controlled external compression, the invention seeks to provide an improved, safer, and more effective solution for reducing pharyngeal reflux and associated pathologies.
Claims Coverage
The independent claim of the patent covers one inventive feature related to a pressure sensing device for use with esophageal sphincter compression technology.
Pressure sensing device with fluid-filled pouch, pressure sensor, controller, and display
The inventive feature consists of: - A pouch defining an interior space that contains a spacing insert and a fluid. - A conduit with a first end in fluid communication with the interior space of the pouch. - A pressure sensor in fluid communication with a second end of the conduit, forming a fluid tight closed volume (pouch, conduit, and sensor) and including a sensing layer and sensing element that generates a pressure signal when the fluid applies pressure to the sensing layer. - A display device. - A controller electrically connected to the pressure sensor and the display device, programmed to: 1. Receive the pressure signal from the sensor 2. Correlate the pressure signal to applied pressure on the pouch 3. Display the applied pressure on the display device.
The main coverage of the claims is directed to a pressure sensing device integrating a sealed fluid-filled pouch, a pressure sensor, and electronic control/display components to measure and indicate applied external pressure for controlled UES compression.
Stated Advantages
The compression device provides a non-pharmacologic and non-invasive means to increase intra-luminal pressure within the upper esophageal sphincter, effectively preventing gastroesophageal and gastroesophagopharyngeal reflux.
The pressure sensing device allows determination and verification of optimal external pressure for each individual patient, enabling safe and effective use.
The compression device maintains sufficient UES pressure during sleep, when natural pressures decline, greatly reducing the risk of reflux and associated complications.
The device is designed to avoid compression of vital vascular structures, with the cushion and frame configured to bridge over the carotid artery and jugular veins.
Use of the device may strengthen the esophageal sphincter through a mechanism analogous to isometric exercise, potentially reducing or eliminating the need for ongoing device use.
The kit is reusable and provides both macro and micro adjustments in applied pressure, enhancing comfort and customization for the patient.
Documented Applications
Reducing pharyngeal reflux in a subject by increasing intra-luminal UES pressure through controlled external compression.
Strengthening an esophageal sphincter of a subject by repeated application and removal of the compression device, potentially augmented by electrical stimulation.
Curing esophageal reflux disease via periodic use of the compression device to strengthen the esophageal sphincter.
Improving vocal function by applying pressure over a specific voice box region of the neck.
Assisting during mechanical ventilation to manage lung aspiration due to involuntary lack of cognitive control of the UES.
Positioning or stabilizing neck internal anatomical structures through mechanical assistance during injury, trauma, or surgical recovery.
Applying cricoid pressure during anesthesia intubation using the Sellick maneuver and for rapid sequence induction.
Immobilizing the subject’s neck during radiation treatment sessions to optimize targeting and avoid radiation overexposure to surrounding tissues.
Applying consistent pressure to manipulate anatomical structures into optimal image position during medical imaging (ultrasound, CT, or MRI) for the neck or other body extremities.
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