A Remotely Controlled Mandibular Repositioner with integrated Continuous Positive Airway Pressure Titrator for Sleep Apnoe

Abstract

INTRODUCTION:The Obstructive Sleep Apnoea Syndrome (OSAS) is a condition characterized by repetitive obstruction of the upper airway which in turn results in oxygen desaturation and arousals from sleep. The prevalence of OSA and OSAS in the Indian population were estimated to be 13.7% and 3.6%, respectively, with that of OSAS in men and women being 4.96% and 2.03%, respectively. It is, therefore, important to develop effective diagnosis and treatment modalities for this condition.Continuous positive airway pressure (CPAP) is currently regarded as the most effective treatment for moderate to severe OSA. But the CPAP device needs a continuous power source, a face mask with a tube sealing and many of them produces continuous sound which reduces the patient compliance of the CPAP. Multiple Polysomnographic titrations Sleep Clinics at multiple nights, both initially for CPAP titration and later, RCMP titrations for efficacy of Anterior Mandibular Positioners are to be done for each patient which is very cumbersome both for the technician and the patient. A Remotely Controlled Mandibular Repositioner With Integrated Continuous Positive Airway Pressure Titrator can reduce the number of titration studies in sleep clinics as both CPAP and RCMP titrations can be done by one single device. Efficacy of Treatment using Anterior Mandibular Positioning devices when used in conjunction with CPAP titration can also be assessed using such a device. It decreases the diagnosis time, reduces the overall manpower and clinical time and inventory which in turn is advantageous to the patient in saving their time and also reduces the treatment cost.

Our aim was to develop an Integrated, Remote Controlled, Continuous Positive Airway Pressure and Mandibular Repositioning Titration Device for Sleep Apnoea Patients.

Brief Description of Invention:  The present invention is related to airway-focused orthodontic devices. It can be applied in sleep clinics is assessing patients who are diagnosed with Obstructive Sleep apnoea (OSA) to titrate the most clinically effective values of mandibular advancement and the pressure that has to be delivered through the face mask of Continuous Positive Airway Pressure (CPAP) device.

Brief Background of Invention: CPAP and mandibular advancement are among the non-invasive first line treatment modalities for of OSA. Multiple Polysomnographic titrations in the Sleep Clinics are to perform for estimating the pressure that has to be delivered through the face mask of Continuous Positive Airway Pressure (CPAP) device. Multiple appointments might be required later to determine the amount of mandibular advancement if the Anterior Mandibular Repositioning (AMP) is the treatment of choice. This device can perform both CPAP and mandibular advancement titration distinctly or simultaneously in on single appointment for a patient which is advantageous for the patient and the clinician.

Description of the product: The design features an upper screw attachment, a lower screw attachment and a mask that has been designed to house them. It also has a stepper motor that can be powered by a DC source and a leadscrew arrangement to achieve the desired motion. The dental impression trays have been modified and two standard M2 nuts are placed on the tray. The screw attachments are fixed with the help of these nuts on to the tray.While the other end of the upper screw attachment is fixed on to the mask, the lower screw attachment is connected to the leadscrew arrangement. The lead screw features a standard M6 bolt (pitch of 1mm) which is connected to a stepper motor. The motor is controlled by a microcontroller (Arduino Uno) and an android interface has been developed to control the movement of the motor wirelessly through Bluetooth from a distance. The CPAP device can be attached to the facemask.So, using a single device, both the CPAP and AMP titration can be effectively done, and the device can be wirelessly controlled using any android device which supports Bluetooth connectivity.

Proof of Concept: A prototype is made The mask houses the stepper motor and the Anterior Mandibular Re-Positioner mechanism. The mandibular re-positioner is attached to the lower jaw and the mask takes support from both the patient’s face and upper jaw. The electronics components of the device, which includes the micro controller, motor driver, bluetooth module and the related circuits are packed onto a single PCB.            

Unique advantages of this innovation:

1. Facilitates the Titration for Continuous positive airway pressure (CPAP) and the RCMP titration for Anterior Mandibular Repositioner in one device.
2. Research studies can be conducted regarding combined treatment methodologies, of mandibular positioning devices and CPAP devices.
3. Reduces the Overall Diagnostic time and inventory.
4. Saves the time of the Patient, Technician, and the Doctor.
5. Reduces the number of appointments for sleep titrations.
6. Scope for Better Standardization and uniform calibrations for sleep studies.
7. Less Bulky and can be handled by anyone without much expertise.
8. Precision on 0.5 mm, makes RCMP movement smooth, makes it more precise and less distracting for the patient.
9. This device can be used worldwide in Sleep Clinics of Hospitals for the effective treatment of Obstructive sleep apnoea.