Method and Device for Treating Sleep Related Breathing Disorders

Abstract

The present disclosure relates to a method for increasing an amount of air and/or oxygen passing through an airway of an individual, reducing airway restrictions in an individual, increasing airway patency and/or maintaining airway patency in an individual, decreasing snoring, obstructive sleep apnea, or a combination thereof, in an individual. The method may comprise stimulating at least four regions of the individual's neck, where two of the at least four regions of the individual's neck are anterior triangle regions on opposing sides of the individual's midline, and another two of the at least four regions of the individual's neck are anterior triangle regions on opposing sides of the individual's midline, posterior to the two of the at least four regions. The present disclosure also discusses related devices and systems.

1 - 44 . (canceled) 
     
     
         45 . A device for decreasing at least one of snoring, obstructive sleep apnea, and upper airway resistance condition in an individual, the device comprising:
 at least four transcutaneous stimulators couplable to at least four regions within an anterior triangle of the individual's neck using at least one removable adhesive, wherein   the first transcutaneous stimulator is couplable to and configured to transcutaneously stimulate the first region within the anterior triangle of the individual's neck,   the second transcutaneous stimulator is couplable to and configured to transcutaneously stimulate the second region within the anterior triangle of the individual's neck,   the third transcutaneous stimulator is couplable to and configured to transcutaneously stimulate the third region within the anterior triangle of the individual's neck,   the fourth transcutaneous stimulator is couplable to and configured to transcutaneously stimulate the fourth region within the anterior triangle of the individual's neck,   the first and second regions within the anterior triangle of the individual's neck are on opposing sides of the individual's midline, and   the third and fourth regions within the anterior triangle of the individual's neck on opposing sides of the individual's midline, and posterior to the first and second regions within the anterior triangle of the individual's neck; and   at least one processor in electrical communication with any combination selected from the group consisting of: the first and third transcutaneous stimulators; the second and fourth transcutaneous stimulators; and the first, the second, the third, and the fourth transcutaneous stimulators, said at least one processor being configured to control the transcutaneous stimulation.   
     
     
         46 . The device of  claim 45 , wherein the device is configured to be coupled to a removable adhesive that is in electrical communication with at least a portion of the at least four transcutaneous stimulators, and
 wherein the removable adhesive, when coupled to the device, is oriented to conduct the electrical stimulation from the at least four transcutaneous stimulators to the at least four regions within the anterior triangle of the individual's neck and to prevent conduction of the electrical stimulation from the at least four stimulators to the individual's neck at regions other than the at least four regions within the anterior triangle of the individual's neck.   
     
     
         47 . The device of  claim 45 , wherein the device is configured to deliver at least two types of biphasic waveform modulations, and
 wherein at least a first type of the at least two types of biphasic waveform modulations is a low-intensity, high frequency waveform and another type of the at least two types of waveform modulations is a high-intensity, low-frequency waveform.   
     
     
         48 . The device of  claim 47 , wherein the at least two types of biphasic waveform modulations comprises at least two pulses, wherein one pulse of the at least two pulses is positive in magnitude and another pulse of the at least two pulses is negative in magnitude. 
     
     
         49 . The device of  claim 45 , wherein the processor is configured to adjust an intensity of the electrical stimulation. 
     
     
         50 . The device of  claim 49 , wherein the processor is configured to adjust the intensity of the electrical stimulation in response to at least one vital sign of the individual while the individual is asleep. 
     
     
         51 . The device of  claim 49 , wherein the processor is configured to adjust the intensity of the electrical stimulation by increasing increments of stimulation intensity until a threshold is met, or by decreasing increments of stimulation intensity until the threshold is met. 
     
     
         52 . The device of  claim 49 , wherein the device reduces airway restrictions in the individual, wherein the device increases the amount of air passing through the airway of the individual, wherein the device increases airway patency in an individual, wherein the device maintains airway patency in an individual, and/or wherein the device increases airway patency in an individual. 
     
     
         53 . The device of  claim 45 , wherein the at least four transcutaneous stimulators are gold-plated or silver-plated copper electrodes. 
     
     
         54 . The device of  claim 45 , wherein the at least four transcutaneous stimulators are oriented in fixed positions relative to one another and configured to stimulate the at least four regions within the anterior triangle of the individual's neck. 
     
     
         55 . The device of  claim 45 , wherein the removable adhesive, when coupled to the device is configured to conduct the electrical stimulation from the at least four transcutaneous stimulators to the at least four regions within the anterior triangle of the individual's neck and to prevent conduction of the electrical stimulation from the at least four transcutaneous stimulators to the individual's neck at regions other than the at least four regions within the anterior triangle of the individual's neck. 
     
     
         56 . The device of  claim 45 , wherein the at least one removable adhesive material is hydrogel. 
     
     
         57 . The device of  claim 45 , wherein the device has a body comprising a first stem and a second stem, and
 wherein the first stem comprising two of the four transcutaneous stimulators configured to stimulate two of the four regions within the anterior triangle of the individual's neck on a first side of the individual's midline, the second stem comprising two of the four transcutaneous stimulators configured to stimulate two of the four regions within the anterior triangle of the individual's neck on a second side of the individual's midline.   
     
     
         58 . The device of  claim 45 , further comprising a radio for wireless communication; a sleep sensor; and a power source coupled to the device and configured to provide an electrical signal to each of the at least four transcutaneous stimulators. 
     
     
         59 . The device of  claim 58 , wherein each of the at least four transcutaneous stimulators is configured to apply transcutaneous stimulation in response to the electrical signal, wherein the applied transcutaneous stimulation results in decrease of the at least one of snoring, obstructive sleep apnea, and upper airway resistance condition, by: increasing the amount of air passing through the airway of the individual; reducing airway restrictions in the individual; and/or by increasing airway patency. 
     
     
         60 . The device of  claim 45 , further comprising an adhesive component, wherein the adhesive component comprises conductive and nonconductive regions, wherein said conductive regions being configured to facilitate electrical communication between each of the four transcutaneous stimulators and the respective regions on the individual's neck, wherein said nonconductive regions of the adhesive component are configured to prevent electrical stimulation from being conducted outside of the four regions of the individual's neck, wherein each of the conductive regions are composed of a hydrogel. 
     
     
         61 . A method for decreasing snoring, obstructive sleep apnea, or a combination thereof in an individual, the method comprising:
 providing the device of  claim 45  and using it to apply transcutaneous stimulation to four regions of the individual's neck, said regions comprising a first anterior triangle region and a second anterior triangle region on opposing sides of the individual's midline; and a third anterior triangle region and a fourth anterior triangle region on opposing sides of the individual's midline, said third and fourth anterior triangle regions being located posterior to the first anterior triangle region and the second anterior triangle region, respectively.   
     
     
         62 . The method of  claim 61 , wherein the transcutaneous stimulation comprises:
 passing current from the first anterior triangle region to the third anterior triangle region; and   passing current from the second anterior triangle region to the fourth anterior triangle region.   
     
     
         63 . The method of  claim 59 , wherein the transcutaneous stimulation is a current produced by two types of waveform modulations; wherein
 wherein the two types of waveform modulations are a low-intensity, high-frequency waveform and a high-intensity, low-frequency waveform,   wherein the high-intensity, low-frequency waveform comprises at least a first pulse and a second pulse, the first pulse being positive in magnitude and the second pulse being negative in magnitude, and   wherein the low-intensity, high-frequency waveform comprises at least a first pulse and a second pulse, the first pulse being positive in magnitude and the second pulse being negative in magnitude.