Abstract:
A non-invasive device for facilitating therapy of patient suffering from the gastrointestinal system diseases or symptoms, and in particular suffering Gastroesophageal reflux disease (GERD). The device is positioned by the patient on the skin of the patient abdomen and electrically stimulates the abdomen muscles. This treating results in dynamic motions of the digestive system, which causes the treatment of various digestive symptoms or diseases.

Description:
FIELD OF THE INVENTION 
       [0001]    The present disclosure relates to medical devices in general, and to medical devices related to digestive system and GERD in particular. 
       BACKGROUND OF THE INVENTION 
       [0002]    Gastroesophageal reflux disease (GERD) is caused by stomach acid coming up from the stomach into the esophagus. The symptoms include abdominal pain, heart burn, asthma, mucosal damage and even cancer. GERD is usually caused by changes in the barrier between the stomach and the esophagus, including abnormal relaxation of the lower esophageal sphincter (LES) (which normally holds the top of the stomach closed), impaired expulsion of gastric reflux from the esophagus, or a hiatal hernia. 
         [0003]    Treatment is typically via lifestyle changes and medications such as proton pump inhibitors (PPI), H2 receptor blockers or antacids. Medication therapy is effective up to 60% of the western world population. It is associated with various adverse effects, raising concern about the safety of its long-term use. 
         [0004]    Surgical therapy (fundoplication) and endoscopic interventions provide an alternative to patients who do not respond to medication therapy, or are reluctant to use such medications for long periods of time, but it is associated with adverse effects. Various endoscopic intervention methods were developed in the last number of years, however, poor efficacy and complications have limited their use in clinical practice. The efficacy of all surgical interventions is decreasing in time. 
         [0005]    U.S. Pat. No. 7,660,636 discloses an electrical stimulation device and method for the treatment of dysphagia. In a preferred embodiment, the electrical stimulation device includes one or more channels of electrodes each of which includes a first electrode positioned in electrical contact with tissue of a target region of a patient and a second electrode positioned in electrical contact with tissue of a posterior neck region or a posterior thoracic region of the patient. A series of electrical pulses are then applied to the patient through the one or more channels of electrodes in accordance with a procedure for treating dysphagia. 
         [0006]    U.S. Pat. No. 5,716,385 an electronic pacemaker is used to counter-act crural diaphragm relaxation thereby preventing and/or treating gastroesophageal reflux. The pacemaker canbe implantable, or be connected to the skeletal muscles of the crural diaphragm through the skin. A sensor is used to identify spontaneous intermittent relaxations of the diaphragm. During these spontaneous intermittent relaxations, one or more electrodes are used to stimulate the skeletal muscles of the crural diaphragm to cause contraction of the lower esophageal sphincter. 
       SUMMARY OF THE INVENTION 
       [0007]    Embodiments of the present invention disclose a non-invasive device for facilitating therapy of patient suffering from the gastrointestinal system diseases or symptoms, and in particular suffering Gastroesophageal reflux disease (GERD). The device is a noninvasive device that is positioned by the patient on the skin of the patient abdomen and electrically stimulates the abdomen muscles. This treating results in dynamic motions of the digestive system, which causes the treatment of various digestive symptoms or diseases. 
         [0008]    In one embodiment, the device causes an increase of the esophagus motility and strengthens the esophageal sphincter, which releases or suppresses the Gastroesophageal reflux symptoms. 
         [0009]    In one other embodiment, the electrical stimulation directs the stomach contents to creep up to the esophagus, causing unpleasant sensation leading to decrease the appetite. The unpleasant sensation occurs when device works both during eating and/or in between meals. The treatment increases the stomach pressure and facilitates the satiation feeling as obesity treatment. 
         [0010]    In one other embodiment the electrical stimulation causes the stomach contents to creep down to the duodenum and to empty the stomach. This treatment is effective in case of paralysis of the stomach. 
         [0011]    In one other embodiment the electrical stimulation cause the transverses colon contents to creep down to the sigmoid colon as a treatment of constipation. In such a case, two channels stimulation may be used. 
         [0012]    The devise may be built from a sealed plastic case that contains an electrical circuit and a battery/batteries pack. In one embodiment, a pair or more of electrodes coated with conductive adhesive (or hydrogel) or other any type of electrodes are attached to the case. In some other embodiments, some or all of the electrodes are separated from the case to be able to locate the electrodes in various locations of the patient abdomen. The device is integrated with a belt that the patient wears. The stimulation program begins when two or more electrodes are in contact with the skin. The user can control the device by keys on the device or by any remote control facilities. 
         [0013]    The device is self-applied for daily use, typically after meal. In order to detemiine the optimal application location on the patient body and find the device optimal parameters (e.g. amplitude, frequency and burst/pulse sequence, etc.) an initial set up session may be required. This session can be done with a trained clinician or via printed or video user guide. 
         [0014]    The stimulation pulses may be monophasic or asymmetrical or symmetric albiphasic in typical rang with a specific time pattern or modulated pattern Wherein time pattern or modulated pattern are denoted as a burst and asymmetrical burst is denoted as a current wave form in which the time of ramp up is different from the time of ramp down. Max Voltage range is +300V (typically 200V), max current range is 150 mA (typical 100 mA); pulse frequency range is 10Hz-100Hz (typical 20Hz−40Hz), burst frequency 0.1-10Hz (typical 0.25Hz-4Hz). 
         [0015]    In some embodiments, the pulses are synchronized with the patient body signals. For example, the pulses may be synchronized with breathing, heart pulse, monotony movements, and body position. Synchronizing may be done by a sensor that is included in the device. Examples of such sensors are Accelerometer, Gyro, Magnetic Compass, Inclinometer and Respiratory Transducer based on a piezoelectric device (for sensing body position, movements and breathing), ECG amplifiers and microphone (for sensing heart rate). 
         [0016]    Breathing, body position and movements changes the stomach and esophagus pressure and position. The synchronization is required for generating optimal pulses only while the abdomen pressure is positive through the inspiration cycles. 
         [0017]    One technical problem dealt with by the present disclosure is how to affect motility of the esophagus and stomach system or/and the diaphragm of a patient in a non-invasive way. 
         [0018]    One technical solution is to continuously electrically stimulating the abdomen muscles, with specific bursts wherein the frequency and the power of stimulation may be controlled by the patient. The burst rapid ramp up direction may be determined in accordance with the symptom. For example, in the case of Gastroesophageal reflux disease (GERD) a specific current wave forms and treatment protocols cause the effect of creeping materials to the stomach direction for treating GERD patient. 
         [0019]    One other technical solution is to create the dynamic motions by a belt that contains a pulse motion mechanism. When the subject wears the belt the mechanism is positioned onto a selected region or regions of the patient abdomen. The mechanism extends and release reciprocally (alternatively inflates and deflates) causing the abdomen wall to follow its movements. The mechanism is activated by a few optional electrical current patterns that are generated by the control unit and synchronized with the patient body signals. 
         [0020]    One technical problem dealt with by the present disclosure is how to cause movement of the content of digestive system of a patient in a non invasive way. 
         [0021]    One technical solution is to generate asymmetrical movements of the digestive system (like the esophagus) by applying asymmetrical electrical stimulation bursts onto the abdomen muscles, wherein the frequency and the power of stimulation may be controlled by the patient. The asymmetrical bursts generate abdomen muscles asymmetrical contractions. Those contractions generates forward and “fast back” displacement of the esophagus (via the stomach) causing the remaining materials creeping back to the stomach, like in “Vibration Conveyer”, wherein the ramp direction is determined in accordance with the desired direction of the digestive system. For example, in the case of Gastroesophageal reflux disease (GERD) a fast ramp direction is upward and the slow phase is downward, causing the content of the esophagus return to the stomach and release the GERD symptoms of the patient. 
         [0022]    One other technical problem dealt with by the present disclosure is how to strengthen the esophageal sphincter 
         [0023]    One other technical solution is electrically stimulating the abdominal muscles. For every burst of stimulation the pressure in the stomach increases causing the esophageal sphincter muscle to contract and to prevent the stomach content entering to the esophagus, numerous times every day. The numerous contractions of the sphincter muscle cause thickening and strengthening of the sphincter which prevent the reflux syndrome in long term. 
         [0024]    One other technical problem is how to optimize the stimulation effect, A burst that acts during the abdomen negative pressure cycles it not effective though a burst that acts during the abdomen positive pressure cycles it effective. 
         [0025]    One other technical solution is synchronizing the pulses timing with the patient body signals. Breathing, body position and movements changes the stomach and esophagus pressure and position. The synchronization is required for generating optimal pulses only while the abdomen pressure is positive through the inspiration cycles. In another embodiment the device synchronizes the pulses generation with heart beat rate measured by ECG (electrocardiogram) sensor. Pulses are generated during the periods of positive values. In another embodiment body position is performed by Gyro and/or accelerometer sensors. 
         [0026]    One exemplary embodiment of the disclosed subject matter is a method for treating gastroesophageal reflux disease (GERD) in a patient. The method comprising: positioning a plurality of electrodes, in electrical contact with the skin of a target region of the patient abdomen; and applying a series of electrical bursts to the electrodes wherein the electrical bursts are adapted for electrically stimulating the abdomen muscles of the patient in the target region; thereby causing the esophageal contents to creep down to the stomach. 
         [0027]    According to some embodiments the method further comprising applying a series of electrical asymmetric bursts to thereby generating asymmetrical contractions of the muscles; wherein a direction of a fast phase of the bursts being upward and a direction of a slow phase of the bursts being downward; thereby generating movements of a digestive system of the patient; wherein the movements being for causing the content of the esophagus to return to the stomach and to release the GERD symptoms of the patient. According to some embodiments the method further comprising synchronizing the pulses with the patient body signals. According to some embodiments the body signals comprise one member of a group consisting of breathing, heart pulse, monotony movements and body position. 
         [0028]    One other exemplary embodiment of the disclosed subject matter is a non-invasive device for treating the digestive system symptoms of a patient; the device comprises: a plurality of electrodes adapted to be placed in electrical contact with the skin of the abdomen; a pulse generator  107  for providing asymmetric bursts electrical stimulation to the electrodes; wherein the asymmetric bursts being for stimulating the abdomen muscles for a moving the digestive system; wherein the moving being for treating a digestive symptom or a diseases; a control unit  103  for controlling the pulse generator  107  wherein maximum voltage range of the pulse being +300V, maximum current range being 150 mA; pulse frequency range being 10 Hz-100 Hz and burst frequency being 0.1-10 Hz.a sensor connectable to the control unit adapted for sensing body-signals from the patient; wherein the control unit is further adapted for synchronizing the pulse generator  107  in accordance with the body-signals to thereby improving the effect of the electrical stimulation. 
         [0029]    According to some embodiments the device digestive system symptoms being one member of a group consisting of reflux, obesity and constipation. According to some embodiments the pulse generator  107  is configured to determine the pulse ramp up direction in accordance with the desired direction. According to some embodiments the sensor being one member of a group consisting of a Piezoelectric Respiratory Belt Transducer for sensing breathing rate, an ECG fbr sensing heartbeat, a Gyro and accelerometer for sensing body movements. 
         [0030]    One other exemplary embodiment of the disclosed subject matter anon-invasive device for treating gastroesophageal reflux disease of a patient; the device comprises: a plurality of electrodes adapted to be placed in electrical contact with the skin of the abdomen; a pulse generator  107  for providing asymmetric electrical stimulation bursts to the electrodes; wherein the asymmetric electrical stimulation bursts being for generating asymmetrical contractions of the muscles; wherein a direction of a fast phase of the bursts being upward and a direction of a slow phase of the burst being downward; thereby generating movements of a digestive system of the patient; wherein the movements being for causing the content of the esophagus to return to the stomach and to release the GRED symptoms of the patient; a control unit for controlling the pulse generator  107  and a sensor adapted for sensing breathing signals from the patient; wherein the control unit is further adapted for synchronizing the pulse generator  107  in accordance with the breathing signals to thereby generating pulses only when the abdomen pressure is positive. According to some embodiments the pulse generator  107  is further configured for providing symmetric electrical stimulation bursts. 
         [0031]    One other exemplary embodiment of the disclosed subject matter a device for treating gastroesophageal reflux disease(GERD) of a patient; the device comprises: a plurality of electrodes adapted to be placed in electrical contact with the skin of the abdomen; a pulse generator  107  for providing electrical stimulation signals to the electrodes; wherein the electrical stimulation bursts being for directing the stomach contents to creep up to the esophagus, to thereby causing unpleasant sensation leading to decrease the appetite for treating obesity or wherein the electrical stimulation bursts being for causing the stomach contents to creep down to the duodenum and to empty the stomach for treating paralysis of the stomach or wherein the electrical stimulation bursts being for causing the transverses colon contents to creep down to the sigmoid colon to thereby treating constipation; and a control unit  103  for controlling the pulse generator  107 . 
         [0032]    THE BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0033]    The present disclosed subject matter will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which corresponding or like numerals or characters indicate corresponding or like components. Unless indicated otherwise, the drawings provide exemplary embodiments or aspects of the disclosure and do not limit the scope of the disclosure. In the drawings: 
         [0034]      FIGS. 1 a  and 1 b    illustrate a device tier treating the digestive system in accordance with some embodiments of the disclosed subject matter; 
         [0035]      FIG. 2  illustrates an example of the asymmetrical burst stimulation monophasicpulses or half wave in case of biphasic pulses, in accordance with some embodiments of the disclosed subject matter; 
         [0036]      FIG. 3  is an illustration of user wearing the device on the abdomen, in accordance with some embodiments of the disclosed subject matter; 
         [0037]      FIG. 4  is an illustration of typical data that is generated by a Piezoelectric Respiratory Belt Transducer, in accordance with some embodiments of the disclosed subject matter; 
         [0038]      FIG. 5  is an illustration of a subject wearing, on the abdomen, a device with a pulse motion mechanism, in accordance with some embodiments of the disclosed subject matter; 
         [0039]      FIG. 6  is a top view illustration of a device with a pulse motion mechanism, in accordance with some embodiments of the disclosed subject matter; and 
         [0040]      FIG. 7  illustrates a force and displacement pulse pattern of the device, in accordance with some embodiments of the disclosed subject matter. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0041]      FIGS. 1 a  and 1 b    illustrate a device for treating the digestive, in accordance with some embodiments of the disclosed subject matter. 
         [0042]      FIG. 1 a   is a top view of the device in accordance with some embodiments of the disclosed subject matter. The device (not shown in this figure) can be worn on the user body via adjustable belt and or pressure sensitive adhesive (PSA). The device (not shown in this figure) generates electrical pulses that are delivered to the user abdomen muscles via two or more electrodes. The device (not shown in this figure) includes a control unit  103 , a control unit case  106 , an adjustable belt  104  and a plurality of electrodes  101  and  102 . 
         [0043]    The control unit  103  includes the electric circuit (printed board) PCB and a battery or multiple batteries pack (not shown in this figure). The control unit  103  includes two or more keys or knobs  105  for turning on/off, selecting the required operation protocol and pulse parameters, and two (or more) LEDs (not shown) for status indication. The control unit  103  is explained in greater details in  figure 1 b   . The adjustable belt ( 104 ) is adapted ensures comfortable and proper attachment of the device (not shown in this figure) to the user body and allows daily activities. 
         [0044]    The control unit case  106  may be constructed to be adequately flexible in order to allow good Lit with the user body. 
         [0045]    The electrodes  101  and  102  are each adapted to be positioned in electrical conduct with the skin of selected regions of a patient abdomen. The electrodes  101  and  102  are replaceable and disposable; they are supplied to the user packed in a sealed watertight package. The electrode structure contains multiple layers that may include a substrate liner; polymer film (e.g. polyester) or foam (e.g. polyurethane) or nonwoven (e.g. polypropylene fibers) coated with conductive layer (e.g. a bland of silver silver-chloride or graphite or metal) and an aqueous conductive adhesive (e.g. conductive hydrogel or viscose layer with water). The electrodes are attached to the control unit side wall or integrated into the adjustable belt  104 , and connected to the control unit  103  via special conductive wires  110 . A siliconized film (release liner) protects the adhesive/hydrogel and is removed before use. 
         [0046]    The electrodes  101  and  102  may be integrated (as shown this figure) or separated (as shown  FIG. 3 ) from the device (not shown in the figure) and can be located in various locations of the user abdomen. 
         [0047]    In order to allow daily operation through clothes there is an option to remotely control the device (not shown in this figure) by using a wire/wireless remote control unite or a special unit with magnet that magnetically operates the switches of the device. 
         [0048]      FIG. 1 b    illustrates the control unit in accordance with some embodiments of the disclosed subject matter. The control unit  103  includes control keys  105 , a case  106  and printed circuit board (PCB)  108 . The PCB  108  includes microcontroller, digital circuits, memory, communication, high voltage circuits, analog circuits, high voltages switches and bridges, protection circuits (not shown) and the pulse generator  107 . The control unit  103  is connected to the electrodes (not shown) with the electrodes conductive wires  110 . The control unit  103  is in electrical contact with the sensors (not shown) via conductive wire  111 . The control unit may be controlled by any remote control device with any type of communication. 
         [0049]      FIG. 2  illustrates an example of the monophasic asymmetrical burst stimulation pulses  200  and the biphasic stimulation pulses  210 , in accordance with some embodiments of the disclosed subject matter. In another embodiment, more types of asymmetrical burst and pulses may be used for example: skew nonlinear curves, asymmetrical stairs pulses. 
         [0050]      FIG. 3  is an illustration of user  300  wearing the device  100  on the abdomen, in accordance with some embodiments of the disclosed subject matter. The adjustable belt  104  is worn on the user  300 . The adjustable belt  104  includes a sensor  109 . The sensor  109  is connected to the control unit  103  via conductive wire (multiple wires cable)  111 . The electrodes  401  and  402  are connected to the device  100  via conductive wires  110 . The second electrode  402  or both electrodes  401  and  402  may be integrated (as shown in  FIG. 1 ) or separated (as shown in this figure) from the device  100  and can be located in various locations of the user abdomen. This structure allows deeper penetration of the pulse current and may be required primarily by obese users with thick layer of fate that may prevent the current to reach the inner abdomen muscles. 
         [0051]      FIG. 4  is an illustration of typical data that is generated by a Piezoelectric Respiratory Belt Transducer, in accordance with some embodiments of the disclosed subject matter. The figure illustrates the change in voltage as a result of a change in thoracic or abdominal circumference due to respiration. By measuring the voltage change the device synchronizes the pulses generation with breathing rate. Pulses are generated during the periods of positive values. 
         [0052]      FIG. 5  is an illustration of a subject wearing, on the abdomen, a device with a pulse motion mechanism, in accordance with some embodiments of the disclosed subject matter. According to some embodiments the dynamic motions of the abdomen are created by a pulse motion mechanism  202  which is mounted on a belt  201  that is worn on the subject  200 . When the subject  200  wears the belt, the mechanism is positioned onto a selected region or regions of the patient abdomen. The mechanism  202  extends and releases sequentially (alternatively inflates and deflates) causing the abdomen wall to follow its movements. The mechanism  202  is activated by a suitable electrical current pattern (to create the required motion) that is generated by the control unit  203 . The mechanism  202  may be synchronized with the patient body signals. 
         [0053]      FIG. 6  is atop view illustration of a device with a pulse motion mechanism, in accordance with some embodiments of the disclosed subject matter. The pulse motion mechanism  202  may include, for example, an electrical linear actuator or a Rotary actuator with an eccentric arm, both can drive a piston  204 . The pulse motion mechanism  202  may also include an air bag ( 204 ). The piston  204  expands and releases in sequence. The air bag  204  sequentially inflates and deflates and is coupled with an electrical air pump and an air valve. The power may be supplied by a battery that is mounted in the control unit (not shown in the figure). Arrow  205  shows the direction of the movement of the piston or an air bag ( 204 ). 
         [0054]      FIG. 7  illustrates force and displacement pulse patterns of the device with a pulse motion mechanism, in accordance with some embodiments of the disclosed subject matter. The resulting force and displacement pulse pattern includes sequential saw teeth pattern  701 , asymmetric trapezoidal pattern  702  and skewed sinusoidal pattern  703 . It should be noted that the pattern may also include symmetrical rectangle pattern or symmetrical sinusoidal pattern (not shown in the figure).