Systems and Methods for Using Transcutaneous Electrical Stimulation to Enable Dietary Interventions

Abstract

The disclosed electrical stimulation system generates interventions to assist patients in complying with a diet. The wearable device includes a microprocessor, electrical stimulator and at least one electrode configured to deliver electrical stimulation to the epidermis, through a range of 0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of the dermis, of a T2 dermatome to a T12 dermatome or meridian of the patient, a C5 to a T1 dermatome across the hand and/or arm, and/or the upper chest regions. The device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient and generate interventions. The control device is also configured to monitor, record, and modify stimulation parameters of the stimulation protocols.

We claim: 
     
         1 . An electrical dermal patch adapted to be continuously worn by a patient, comprising,
 a housing comprising a controller in electrical communication with a pulse generator; and   two electrodes adapted to be adhered to the patient's skin, positioned in a same plane parallel to the patient's skin, separated by a distance of 0.05 cm 2  to 0.4 cm 2  and in electrical communication with the pulse generator, wherein the controller comprises programmatic instructions that, when executed and transmitted to the pulse generator, cause the pulse generator to generate and transmit to the at least two electrodes a first set of electrical stimulation pulses and a second set of electrical stimulation pulses and wherein each of the at least two electrodes comprise a hypoallergenic conductive gel with at least one adhesive surface, wherein the hypoallergenic conductive gel does not comprise imidazolidinyl urea or diazolidinyl urea and wherein the at least one adhesive surface is adapted to adhere to the patient's skin and have a total skin contact surface area in a range of 2 cm 2  to 4 cm 2 .   
     
     
         2 . The electrical dermal of  claim 1 , wherein the electrode comprises carboxymethylcellulose polymer and propylene glycol. 
     
     
         3 . The electrical dermal of  claim 1 , wherein each of the electrical stimulation pulses is defined by a charged balanced biphasic waveform and wherein the first set of electrical stimulation pulses and second set of electrical stimulation pulses are separated by a predefined time interval. 
     
     
         4 . The electrical dermal patch of  claim 3 , wherein the predefined time interval is randomized and is at least 1 minute long. 
     
     
         5 . The electrical dermal patch of  claim 3 , wherein the pulse generator has a maximum compliance voltage in a range of 40 volts to 60 volts. 
     
     
         6 . The electrical dermal patch of  claim 3 , wherein each of the electrical stimulation pulses is defined by a waveform characterized by a first period, a second period, and a third period, wherein the first period comprises at least a portion of 0 to 10 μs of the waveform, the second period comprises at least a portion of 10 μs to 100 μs of the waveform, and the third period comprises at least a portion of 100 μs to 200 μs of the waveform, wherein the first period is defined by a maximum amplitude and the second and third periods are defined by a remainder amplitude less than said maximum amplitude. 
     
     
         7 . The electrical dermal patch of  claim 6 , wherein the maximum amplitude is in a range of 20 mA to 40 mA. 
     
     
         8 . The electrical dermal patch of  claim 6 , wherein, in the second period, a decay of said remainder amplitude is defined by a first negative slope having a first magnitude and, in the third period, a decay of said remainder amplitude is defined by a second negative slope having a second magnitude, wherein the first magnitude is less than the second magnitude. 
     
     
         9 . The electrical dermal patch of  claim 6 , wherein an average of the maximum amplitude and the remainder amplitude is in a range of 10 mA to 20 mA. 
     
     
         10 . A method of using the electrical dermal patch of  claim 1  comprising:
 programming the controller such that each of the electrical stimulation pulses comprises a pulse width in a range of 10 μsec to 10 msec, a pulse amplitude in a range of 100 μA to 100 mA, and a pulse frequency in a range of 1 Hz and 100 Hz; and 
 determining if the patient experiences a change in appetite as a result of an application of said first set of electrical stimulation pulses or said second set of electrical stimulation pulses to the patient's skin; and 
 determining if the patient experiences erythema, scaling, pruritus, folliculitis, or intertrigo at a point where the two electrodes adhere to the patient's skin. 
 
     
     
         11 . An electrical dermal patch adapted to be continuously worn by a patient, comprising:
 a housing comprising a controller in electrical communication with a pulse generator; and   two electrodes adapted to be adhered to the patient's skin, wherein the two electrodes are positioned in a same plane, parallel to the patient's skin, separated by a distance of 0.05 cm 2  to 0.4 cm 2  and in electrical communication with the pulse generator, wherein the controller comprises programmatic instructions that, when executed and transmitted to the pulse generator, cause the pulse generator to generate and transmit to the at least two electrodes a first set of electrical stimulation pulses and a second set of electrical stimulation pulses; and   at least one impedance sensor configured to determine data indicative of an amount of fat in the patient.   
     
     
         12 . The electrical dermal of  claim 11 , wherein the first set of electrical stimulation pulses and the second set of electrical stimulation pulses are defined by an amplitude ranging from 1 μA to 500 mA and a frequency ranging from 0.1 Hz to 10,000 Hz. 
     
     
         13 . The electrical dermal of  claim 11 , wherein the first set of electrical stimulation pulses and the second set of electrical stimulation pulses are defined by a charged balanced biphasic waveform and wherein the first set of electrical stimulation pulses and the second set of electrical stimulation pulses are separated by a predefined time interval. 
     
     
         14 . The electrical dermal patch of  claim 13 , wherein the predefined time interval is randomized and is at least 1 minute long. 
     
     
         15 . The electrical dermal patch of  claim 11 , wherein the at least one impedance sensor is configured to further determine an integrity of the two electrodes and determine contact integrity of said two electrodes with tissues to be stimulated. 
     
     
         16 . The electrical dermal patch of  claim 13 , wherein the first set of electrical stimulation pulses and the second set of electrical stimulation pulses are defined by a waveform characterized by a first period, a second period, and a third period, wherein the first period comprises at least a portion of 0 to 10 μs of the waveform, the second period comprises at least a portion of 10 μs to 100 μs of the waveform, and the third period comprises at least a portion of 100 μs to 200 μs of the waveform, wherein the first period is defined by a maximum amplitude and the second and third periods are defined by a remainder amplitude less than said maximum amplitude. 
     
     
         17 . The electrical dermal patch of  claim 16 , wherein the maximum amplitude is in a range of 20 mA to 40 mA. 
     
     
         18 . The electrical dermal patch of  claim 16 , wherein, in the second period, a decay of the remainder amplitude is defined by a first negative slope having a first magnitude and, in the third period, a decay of the remainder amplitude is defined by a second negative slope having a second magnitude, wherein the first magnitude is less than the second magnitude. 
     
     
         19 . The electrical dermal patch of  claim 16 , wherein an average of the maximum amplitude and the remainder amplitude is in a range of 10 mA to 20 mA. 
     
     
         20 . A method of using the electrical dermal patch of  claim 11  comprising:
 programming the controller such that each of the electrical stimulation pulses comprises a pulse width in a range of 10 μsec to 10 msec, a pulse amplitude in a range of 100 μA to 100 mA, and a pulse frequency in a range of 1 Hz and 100 Hz; and 
 determining if the patient experiences a change in appetite as a result of an application of said first set of electrical stimulation pulses or said second set of electrical stimulation pulses to the patient's skin; and 
 confirming the patient does not experience erythema, scaling, pruritus, folliculitis, or intertrigo at a point where the two electrodes adhere to the patient's skin.