Systems, methods and devices for sensing emg activity

Abstract

Some embodiments of the present disclosure are directed to methods, systems and probe devices for detecting EMG activity. In some embodiments, such methods, systems and devices are used in aiding the diagnosis of Obstruction Sleep Apnea (OSA). In some embodiments, a probe is provided and comprises an elongated member configured with a size and shape for placement adjacent at least one of the soft palate and pharyngeal wall of the patient after insertion of the probe into the patient. The probe may also include at least one sensor configured to sense at least EMG activity of muscle layers of at least one of the soft palate and pharyngeal wall and output sensor signals corresponding thereto. The signals may be monitored for EMG activity, and based on such activity, in some embodiments, a determination of whether the sensor signals of the detected EMG activity correspond to spontaneous EMG activity and/or abnormal motor unit potentials (MUPs).

1 - 8 . (canceled) 
     
     
         9 . A method for aiding in the diagnosis of a condition of a patient comprising:
 providing a probe comprising a plurality of bipolar surface electrodes arranged in an array on a flexible printed circuit board (FPCB) and configured thereon for placement on the surface of tissue of a patient at a first location and configured to produce first signals responsive to at least EMG activity of at least one muscle and/or muscle layer proximate the first location, wherein the probe is configured with a size and shape to effect placement of the at least one sensor at the first location such that the sensor can detect EMG activity of the at least one muscle;   analyzing the first signals, and   determining whether the first signals correspond to EMG activity of the at least one muscle and/or muscle layer.   
     
     
         10 . The method of  claim 9 , further comprising diagnosing a condition of the patient based upon the determined EMG activity. 
     
     
         11 . The method of  claim 10 , wherein the determined EMG activity corresponds to spontaneous EMG activity and/or abnormal MUP's of the at least one muscle. 
     
     
         12 . The method of  claim 9 , wherein the surface of the tissue comprises mucosal tissue. 
     
     
         13 . The method of  claim 11 , wherein determining spontaneous activity comprises determining whether the first signals comprise at least one of fibrillation potentials, positive sharp waves, complex repetitive discharges, fasciculation potentials, and myokymic discharges. 
     
     
         14 . The method of  claim 11 , wherein determining abnormal MUP's comprises evaluating one or more parameters of MUPs of the determined EMG activity for deviations from MUP benchmarks that indicate normal MUP's. 
     
     
         15 . The method of  claim 14 , wherein the one or more parameters are selected from the group consisting of: area, size, shape, complexity, amplitude, duration, and phases of MUPs of the determined EMG activity. 
     
     
         16 . The method of  claim 9 , wherein the size and shape of the probe are configured to position the plurality of bipolar surface electrodes proximate the muscle layers of at least one of the soft palate, pharyngeal wall, and tongue, and wherein the method further differentiates EMG activity from EMG artifacts. 
     
     
         17 . The method of  claim 9 , wherein upon a determination of EMG ac the method further comprises grading the determined EMG activity. 
     
     
         18 . The method of  claim 9 , wherein grading comprises determining one or more periods of occurrence of the determined EMG activity. 
     
     
         11 . The method of  claim 9 , wherein grading comprises determining one or more periods of occurrence of the spontaneous EMG activity and/or abnormal MUP's. 
     
     
         19 . The method of  claim 18 , wherein the periods comprise at least one of rare, occasional, frequent and abundant. 
     
     
         20 . The method of  claim 9 , wherein the probe further comprises a thermal sensor. 
     
     
         21 . The method of  claim 9 , wherein at least one electrode of the plurality of bipolar surface electrodes is spherical. 
     
     
         22 . The method of  claim 9 , wherein each electrode of the plurality of bipolar surface electrodes is spaced apart from an adjacent bipolar surface electrode by about 5 mm, or the spacing is configured to correspond to the muscle arrangement of the back of the mouth/pharynx area such that at least one electrode is positioned proximate a specific muscle or muscle layer. 
     
     
         23 . The method of  claim 22 , wherein the size and shape of the probe is configured for placement of at least one electrode of the plurality of bipolar surface electrodes is adjacent at least one of the soft palate, pharyngeal wall and tongue, and wherein the thermal sensor is configured to output temperature signals corresponding to the temperature of at least one of the soft palate, pharyngeal wall and tongue. 
     
     
         24 . The method of  claim 9 , wherein the size and shape of the probe is configured such that the at least one sensor contacts at least one of the Levator Palatini, Tensor Palatine, Palatopharyngeus, Palatoglossus, Muscularis Mucosae and Musculus Uvulae. 
     
     
         25 . The method of  claim 9 , wherein the size and shape of the probe are configured to effect placement of the at least one sensor proximate at least one of the soft palate, pharyngeal wall, and tongue, and wherein the method further comprises determining at least one of the quality and condition of at least one of the muscle, nerve and tissue dynamics of the soft palate, pharyngeal wall, and tongue. 
     
     
         26 . The method of  claim 9 , wherein:
 the at least one sensor comprises an array of sensors,   the size and shape of the probe are configured to effect placement of each sensor proximate one or more muscle layers of at least one of the soft palate, pharyngeal, and tongue,   the method is further configured to determine whether the determined EMG activity comprises opposite side synchronization and symmetry of the EMG activity of at least the palate, and comparing the EMG activity with that of EMG activity of a non-apnea patient.   
     
     
         27 . The method of  claim 9 , further comprising:
 arranging the plurality of bipolar surface electrodes on the surface of mucosal tissue of a patient each at a predetermined location on tissue, each predetermined location plurality of locations, each location corresponding to a specific muscle and/or muscle layer, wherein each electrode configured to produce first signals responsive to spontaneous EMG activity and/or abnormal MUP's of the specific muscle/layer;   determining whether the first signals of any of the electrodes correspond to spontaneous EMG activity and/or abnormal MUP's of respective muscles/layers; and   determining whether the spontaneous EMG activity and/or abnormal MUP's of one or more muscles/layers are indicative of obstructive sleep apnea.