Apparatus and Method for Treating Obstructive Sleep Apnea

Abstract

There is disclosed a method and apparatus for treating obstructive sleep apnea (OSA) using either one or both of transcutaneous electrical stimulation (“TES”) and/or a continuous positive airway pressure (“CPAP”), and more specifically to an apparatus and method that uses blood oxygen data to control TES applied to certain nerves and muscles in a person's upper airway and/or to control a CPAP machine to treat OSA. A controller is adapted to receive blood oxygen data from a device such as a pulse oximeter and is programmed to apply TES and/or CPAP when the blood oxygen indicates that the person's blood oxygen is below a predetermined threshold.

1 . A controller comprising an input adapted to receive data indicative of a person's blood oxygen level and one or more outputs adapted to communicate with at least one of (i) a source for non-invasively stimulating one or more nerves or muscles only in the person's upper airway and (ii) a continuous positive airway pressure (CPAP) machine, the controller further comprising program code that, when executed, regulates via the one or more outputs, at least one of the source of the stimulation and the CPAP machine based solely on the data indicative of blood oxygen level, the controller being adapted to receive instructions from a device equipped with an app for specifying at least one of (iii) characteristics of the stimulation and (iv) air pressure to be supplied to a mask of the CPAP machine, such that one or more of the characteristics of the stimulation or air pressure supplied to the mask may be adjusted via the app. 
     
     
         2 . The controller according to  claim 1  wherein the data indicative of the person's blood oxygen level is supplied by a pulse oximeter. 
     
     
         3 . The controller according to  claim 1  wherein the source of the stimulation comprises a device for applying transcutaneous electrical nerve stimulation (TES). 
     
     
         4 . The controller according to  claim 3  wherein the device for applying TES further comprises electrodes adapted to be attached to a surface of the person's skin adjacent the person's upper airway for applying the TES. 
     
     
         5 . The controller according to  claim 3  wherein the characteristics comprise one or more of burst rate, voltage polarity, wave shape and inversion of a TES signal. 
     
     
         6 . The controller according to  claim 1  wherein the program code is adapted to regulate both the source of the stimulation and the CPAP machine. 
     
     
         7 . The controller according to  claim 1  wherein the program code is adapted to regulate at least one of the source of the stimulation and the CPAP machine based upon whether the person's blood oxygen level is below a predetermined threshold. 
     
     
         8 . The apparatus according to  claim 7  wherein the predetermined threshold is 90%. 
     
     
         9 . The controller according to  claim 6  wherein the source of the stimulation comprises a device for applying, via electrodes adapted to be attached to the person's skin, transcutaneous electrical stimulation (TES) to the person's upper airway, the program code being adapted to regulate both the TES device and the CPAP machine, the CPAP machine comprising a mask having the electrodes incorporated therein. 
     
     
         10 . The controller according to  claim 2  wherein the pulse oximeter, the source of stimulation and the controller are integrated as a single unit. 
     
     
         11 . A system comprising a pulse oximeter for providing data indicative of a person's blood oxygen level, a controller, and at least one of (i) a source of transcutaneous electrical nerve stimulation (TES) for non-invasive application of TES via electrodes attached to a surface of a person's skin adjacent the person's upper airway to non-invasively stimulate one or more nerves or muscles only in the person's upper airway and (ii) a continuous positive airway pressure (CPAP) machine, the controller being programmed to regulate at least one of the TES and the CPAP machine based solely on the data indicative of blood oxygen level, so as to control at least one of the source of TES and the CPAP machine based solely upon the data indicative of person's blood oxygen level, the controller being adapted to receive program instructions from a device equipped with an app for specifying at least one of (iii) characteristics of the TES including at least one of burst rate, voltage polarity, wave shape and inversion of a TES signal and (iv) air pressure to be supplied to a mask of the CPAP machine, such that one or more of the characteristics may be adjusted via the app. 
     
     
         12 . The system according to  claim 11  wherein the controller is programmed to regulate both the source of TES and the CPAP machine. 
     
     
         13 . The system according to  claim 11  wherein the controller is programmed to apply at least one of TES and CPAP when the data indictive of a person's blood oxygen level indicates that the person's blood oxygen is below a predetermined threshold. 
     
     
         14 . The system according to  claim 12  wherein the CPAP machine includes a mask having the electrodes incorporated therein. 
     
     
         15 . The system according to  claim 13  wherein the predetermined threshold is approximately 90%. 
     
     
         16 . The system according to  claim 11  wherein the pulse oximeter, the source of TES, and the controller are integrated as a single unit. 
     
     
         17 . The system according to  claim 11  wherein the pulse oximeter, the CPAP machine and the controller are integrated as a single unit. 
     
     
         18 . The system according to  claim 12  wherein the pulse oximeter, the source of TES, the CPAP machines and the controller are integrated as a single unit. 
     
     
         19 . A system comprising a pulse oximeter for providing data indicative of a person's blood oxygen level, a controller, and at least one of (i) a source of transcutaneous electrical nerve stimulation (TES) for non-invasive application of TES via electrodes attached to a surface of a person's skin adjacent the person's upper airway to non-invasively stimulate one or more nerves or muscles only in the person's upper airway and (ii) a continuous positive airway pressure (CPAP) machine, the controller being programmed to regulate at least one of the TES and the CPAP machine based solely on the data indicative of blood oxygen level, so as to control at least one of the source of TES and the CPAP machine based solely upon the data indicative of person's blood oxygen level, the controller being adapted to receive program instructions from a device equipped with an app for specifying at least one of (iii) characteristics of the TES including at least one of burst rate, voltage polarity, wave shape and inversion of a TES signal and (iv) air pressure to be supplied to a mask of the CPAP machine, such that one or more of the characteristics may be adjusted via the app, the controller being programmed to apply at least one of TES and CPAP when the data indictive of a person's blood oxygen level indicates that the person's blood oxygen is below a predetermined threshold.