Systems and methods for enabling appetite modulation and/or improving dietary compliance using an electro-dermal patch

• US 10,118,035 B2
• Filed: 02/24/2016
• Issued: 11/06/2018
• Est. Priority Date: 02/24/2015
• Status: Active Grant

• Current Assignee: Elira, Inc.
• Original Assignee: Elira, Inc.
• Inventors: Perez, Raul E., Goode, Paul V., Hong, Peter I., Diianni, Steven, Malave, Luis Jose, Stengel, Brad, Faul, John L.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US15/052,791
• Publication Number:
  US 20170021172A1
• Time in Patent Office: 986 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4211 Diagnosing or evaluating reflux
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36031 : using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/36128 : Control systems
• CPC Class Codes: A61N 1/37211 : Means for communicating with stimulators
• CPC Class Codes: A61N 1/37235 : Aspects of the external programmer

Abstract

A wearable device for suppressing appetite or hunger in a patient 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 frontal thoracic dermatome to a T12 frontal thoracic dermatome or meridian of the patient and/or front or back, C5-T1 dermatome across the hand and/or arm, and/or the upper chest regions. The device includes a pad, in which the electrode is disposed, for secure placement of the device on a skin surface of a patient. 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. The control device is also configured to monitor, record, and modify stimulation parameters of the stimulation protocols.

Claims

1. An electrical dermal patch configured to modulate a patient'"'"'s appetite comprising:

a housing adapted to be positioned on the patient'"'"'s skin;

a controller positioned within the housing;

at least one electrode adapted to be in electrical contact with said patient'"'"'s skin;

a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate a plurality of electrical pulses, each of said plurality of electrical pulses being defined by a plurality of stimulation parameters, wherein said plurality of stimulation parameters are selected such that the patient'"'"'s appetite is modulated from a first state, prior to stimulation, to a second state after stimulation; and

a transceiver in electrical communication with the controller, wherein said transceiver is configured to communicate wirelessly with an external device and to receive a signal representative of at least one parameter of the plurality of stimulation parameters, wherein the at least one parameter is a pulse width, a pulse amplitude, a pulse frequency, a pulse shape, a stimulation session duration, a duty cycle, or a stimulation session frequency.

2. The electrical dermal patch of claim 1 wherein the appetite of said patient, in the first state, is greater than the appetite of said patient in the second state.

3. The electrical dermal patch of claim 1 wherein a first portion of said housing is encased in a first polymer, having a first durometer value, and a second portion of said housing is encased in a second polymer, having a second durometer value, wherein said first durometer value is higher than the second durometer value.

4. The electrical dermal patch of claim 3 wherein said first polymer is positioned over a periphery of the housing.

5. The electrical dermal patch of claim 3 wherein said second polymer is positioned over a center of the housing.

6. The electrical dermal patch of claim 1 wherein at least a portion of said housing is covered by at least one polymer having a hardness measure of 45-65 on a subzero shore scale.

7. The electrical dermal patch of claim 1 wherein at least a portion of said housing is encased in at least one polymer having a tensile modulus of 30 psi to 45 psi.

8. The electrical dermal patch of claim 1 wherein said electrical dermal patch has a measurement of 10 psi to 35 psi on a flexural modulus scale.

9. The electrical dermal patch of claim 1 further comprising a circuit substrate positioned within said housing, wherein the controller and the pulse generator are positioned on the circuit substrate and wherein the circuit substrate comprises at least one joint.

10. The electrical dermal patch of claim 9 wherein said at least one joint joins a first portion of the circuit substrate and a second portion of the circuit substrate such that said first portion is configured to tilt relative to said second portion at said joint when pressure is placed on the circuit substrate.

11. The electrical dermal patch of claim 1 further comprising a circuit board positioned within said housing, wherein the controller and the pulse generator are positioned on the circuit board and wherein the circuit board has a maximum area of 1.5 in².

12. The electrical dermal patch of claim 1 wherein the electrical dermal patch has a volume in a range of 0.25 in³ to 0.5 in³.

13. The electrical dermal patch of claim 1 wherein the electrical dermal patch has a weight in a range of 15 grams to 80 grams.

14. The electrical dermal patch of claim 1 wherein the electrical dermal patch is adapted to operate with a current density in a range of 10 μ

A/in² to 5000 mA/in².

15. The electrical dermal patch of claim 1 further comprising a hydrogel pad having a top surface and a bottom surface, wherein the top surface is physically attached to a base of said housing and wherein said hydrogel pad is in electrical communication with the electrode.

16. The electrical dermal patch of claim 15 further comprising an adhesive layer positioned on the bottom surface of the hydrogel pad.

17. The electrical dermal patch of claim 16 wherein, when the adhesive layer of the electrical dermal patch is adhered to the patient'"'"'s skin, the electrical dermal patch has an average minimum peel strength in a range of 1.3 to 1.7 newtons.

18. The electrical dermal patch of claim 1 further comprising a pad including a water based absorbing polymer and a water based electrolyte, wherein the pad has a top surface and a bottom surface, and wherein the top surface is in electrical communication with the at least one electrode.

19. The electrical dermal patch of claim 18 further comprising a flexible circuit comprising said at least one electrode, wherein the at least one electrode is positioned in physical contact with said pad.

20. The electrical dermal patch of claim 19 wherein the flexible circuit comprises a dielectric laminate having no more than three layers and having a thickness no greater than 0.005 inches.

21. The electrical dermal patch of claim 18 further comprising a polymer film positioned on the bottom surface of the pad, wherein said polymer film comprises a removal tab and an adhesive.

22. The electrical dermal patch of claim 1, wherein the housing has a substantially linear profile, a width of 2 inches or less, a length of 5 inches or less, a height of 0.25 inches or less, or a weight of 5 ounces or less.

23. The electrical dermal patch of claim 1 wherein the housing is hermetically sealed.

24. The electrical dermal patch of claim 1 further comprising a power source, wherein said power source is a single battery having a voltage in a range of 1.0 V to 4.5 V.

25. The electrical dermal patch of claim 1 wherein the at least one electrode is configured in a comb pattern, having a linear backbone with a plurality of elongated teeth extending perpendicularly therefrom.

26. The electrical dermal patch of claim 1 further comprising a pad having a water based absorbing polymer and a water based electrolyte, wherein the pad has a top surface and a bottom surface, and wherein the top surface is physically attached to a base of said housing and wherein the at least one electrode is printed on the top surface of the pad.

27. The electrical dermal patch of claim 1 wherein the electrical dermal patch has an ingress protection rating of at least IPX7, thereby adapted to enable the patient to expose the electrical dermal patch to water for at least 30 minutes without sustaining water damage to the electrical dermal patch.

28. The electrical dermal patch of claim 1 further comprising a circuit having a plurality of electrical contacts.

29. The electrical dermal patch of claim 28 wherein the plurality of electrical contacts comprises gold-plated copper pads etched into said circuit.

30. The electrical dermal patch of claim 29 wherein a periphery of the circuit is covered by overmolded material and wherein a central portion of the circuit is not covered by the overmolded material.

31. The electrical dermal patch of claim 30 further comprising a gel pad, wherein the at least one electrode is positioned in the gel pad and wherein the gel pad is configured to be attached to the central portion of the circuit.

32. The electrical dermal patch of claim 31 wherein the plurality of electrical contacts and at least one electrode in the gel pad are electrically connected and wherein said electrical connection comprises a capacitance type connection.

33. The electrical dermal patch of claim 1 further comprising a circuit board upon which said controller and said pulse generator are mounted.

34. The electrical dermal patch of claim 33 wherein the circuit board has a perimeter and comprises a plurality of perforation holes positioned along said perimeter.

35. The electrical dermal patch of claim 1 wherein said plurality of electrical pulses are configured to be delivered in a session duration in a range of 50 ms to 120 min and in a session frequency in a range of at least one 1 time per week.

36. The electrical dermal patch of claim 1 wherein the pulse generator is configured to generate an electrical field, wherein the electrical field is adapted to penetrate, via the at least one electrode, a range of 0.1 mm to 25 mm through the patient'"'"'s skin.

37. The electrical dermal patch of claim 1 wherein the plurality of electrical pulses comprise a pulse width in a range of 10 μ

sec to 100 msec, a pulse amplitude in a range of 100 μ

A to 500 mA, and a pulse frequency in a range of 1 Hz to 10,000 Hz.

38. The electrical dermal patch of claim 1 wherein the plurality of electrical pulses comprise a pulse width in a range of 10 μ

sec to 10 msec and a pulse amplitude in a range of 15 mA to 30 mA.

39. The electrical dermal patch of claim 1 wherein the plurality of electrical pulses comprise a pulse amplitude in a range of 100 μ

A to 100 mA.

40. The electrical dermal patch of claim 1 wherein the plurality of electrical pulses comprise a pulse width in a range of 10 μ

sec to 100 msec and a pulse amplitude in a range of 5 mA to 45 mA.

41. The electrical dermal patch of claim 1 further comprising an actuator configured to turn the electrical dermal patch on or off.

42. The electrical dermal patch of claim 1 further comprising an actuator configured to provide a tactile indicator, wherein said tactile indicator provides information about a power state of the electrical dermal patch, a commencement or conclusion of a stimulation session, a malfunction of the electrical dermal patch, or a state of a power source.

43. The electrical dermal patch of claim 1 wherein said controller is adapted to automatically adjust the pulse amplitude in order to maintain a constant current.

44. The electrical dermal patch of claim 1 further comprising an impedance sensor configured to determine contact integrity of the at least one electrode to the patient'"'"'s skin.

45. The electrical dermal patch of claim 1 further comprising an impedance sensor, wherein the impedance sensor is configured to generate an impedance signal and transmit said impedance signal to the controller and wherein said controller is adapted to use said impedance signal to determine whether a degree of contact of the at least one electrode to the patient'"'"'s skin meets a threshold value.

46. The electrical dermal patch of claim 45 wherein said threshold value is in a range of 200 to 1000 ohms.

47. The electrical dermal patch of claim 45 wherein said at least one of the controller or the pulse generator is adapted to automatically adjust the pulse amplitude based upon said impedance signal in order to maintain a constant current.

48. The electrical dermal patch of claim 45 wherein said at least one of the controller or the pulse generator is adapted to automatically adjust the pulse amplitude based upon said impedance signal within a voltage range of 0.1V to 500V.

49. The electrical dermal patch of claim 1 further comprising an impedance sensor, wherein the impedance sensor is configured to generate an impedance signal and transmit said impedance signal to the controller and wherein said controller is adapted to use said impedance signal to determine a value indicative of at least one of an amount of body fat of the patient or a body mass index of the patient.

50. The electrical dermal patch of claim 1 further comprising an impedance sensor, wherein the impedance sensor is configured to generate an impedance signal and transmit said impedance signal to the controller and wherein said controller is adapted to use said impedance signal to determine if the at least one electrode is in electrical contact with the patient'"'"'s skin.

51. The electrical dermal patch of claim 1 further comprising an impedance sensor, wherein the impedance sensor is configured to generate an impedance signal and transmit said impedance signal to the controller and wherein said controller is adapted to use said impedance signal to determine if the at least one electrode is not in electrical contact with the patient'"'"'s skin.

52. The electrical dermal patch of claim 1 further comprising an impedance sensor, wherein the impedance sensor is configured to generate an impedance signal and transmit said impedance signal to the controller and wherein said controller is adapted to use said impedance signal to modulate the pulse amplitude in order to maintain a substantially constant current.

53. The electrical dermal patch of claim 1 further comprising an impedance sensor, wherein the impedance sensor is configured to generate an impedance signal and transmit said impedance signal to the controller and wherein said controller is adapted to use said impedance signal to determine a value indicative of a hydration state of the patient.

54. The electrical dermal patch of claim 1 further comprising an accelerometer configured to monitor a degree of the patient'"'"'s movement.

55. The electrical dermal patch of claim 1 further comprising a neural sensor configured to detect a presence of neural activity and generate at least one of an indication that the electrical dermal patch is placed in a right location, an indication that the electrical dermal patch is increasing neural activity in accordance with a stimulation protocol, an indication that a neural response rate of the patient is insufficient, or an indication that a stimulation protocol needs to be modified.

56. The electrical dermal patch of claim 1 wherein the electrical dermal patch does not comprise an on or off switch.

57. The electrical dermal patch of claim 1 wherein the electrical dermal patch is adapted to operate in a first operational state and in a second operational state, wherein, in the first operational state, the electrical dermal patch has a first average current usage and wherein, in the second operational state, the electrical dermal patch has a second average current usage, wherein the second average current usage is at least 1 μ

A greater than the first average current usage.

58. The electrical dermal patch of claim 57 wherein, in the first operational state, the electrical dermal patch is not configured to generate said plurality of electrical pulses.

59. The electrical dermal patch of claim 58 wherein, in the second operational state, the electrical dermal patch is configured to generate said plurality of electrical pulses.

60. The electrical dermal patch of claim 1 wherein said controller is adapted to generate a signal based on the at least one parameter of the plurality of electrical pulses and transmit said signal to the pulse generator.

61. The electrical dermal patch of claim 60 wherein said pulse generator is configured to generate a plurality of electrical pulses in accordance with said signal from the controller.

62. The electrical dermal patch of claim 1 wherein said pulse generator is configured to generate a plurality of electrical pulses based upon the at least one parameter of the plurality of electrical pulses.

63. The electrical dermal patch of claim 1 wherein the electrical dermal patch is adapted to operate in a first operational state and in a second operational state, wherein, in the first operational state, the electrical dermal patch has a first average current usage, wherein, in the second operational state, the electrical dermal patch has a second average current usage, wherein the second average current usage is at least 1 μ

A greater than the first average current usage, and wherein the electrical dermal patch is configured to switch from said first operational state to said second operational state upon receiving a signal from the external device.

64. The electrical dermal patch of claim 1 wherein said controller is configured to modify at least one parameter of the plurality of electrical pulses based upon an input from the external device, wherein the at least one parameter of the plurality of electrical pulses is the pulse width, the pulse amplitude, the pulse frequency, a pulse shape, a stimulation session duration, a duty cycle, and a stimulation session frequency.

65. The electrical dermal patch of claim 64 wherein said input is a value indicative of the patient'"'"'s hunger, a value indicative of a desired change in the patient'"'"'s hunger, a value indicative of the patient'"'"'s appetite, a value indicative of a desired change in the patient'"'"'s appetite, a value indicative of the patient'"'"'s nausea level, a value indicative of a desired change in the patient'"'"'s nausea level, a value indicative of the patient'"'"'s weight, a value indicative of a desired change in the patient'"'"'s weight, a value indicative of an amount of calories consumed by the patient, a value indicative of a desired change in an amount of calories consumed by the patient, a value indicative of an amount of calories expended by the patient, a value indicative of a desired change in an amount of calories expended by the patient, a value for the pulse width, a value for the pulse amplitude, a value for the pulse frequency, a value for a pulse shape, a value for a stimulation session duration, a value for a duty cycle, a value for a stimulation session frequency, a change in value for the pulse width, a change in value for the pulse amplitude, a change in value for the pulse frequency, a change in value for the pulse shape, a change in value for the stimulation session duration, a change in value for the duty cycle, or a change in value for the stimulation session frequency.

66. The electrical dermal patch of claim 1 wherein the electrical dermal patch is adapted to operate in a first operational state and in a second operational state, wherein:

in the first operational state, the electrical dermal patch has an average first current usage and the electrical dermal patch is not configured to generate said plurality of electrical pulses;

in the second operational state, the electrical dermal patch has an average second current usage and the electrical dermal patch is configured to generate said plurality of electrical pulses, wherein the average second current usage is equal to the first current usage plus at least 1 μ

A;

the controller is configured to automatically switch from said first operational state to said second operational state upon receiving a signal from the external device; and

the controller is configured to automatically modify at least one of said pulse width, said pulse amplitude, said pulse frequency, a pulse shape, a duty cycle, a session duration, or a session frequency based upon an input of a value indicative of the patient'"'"'s hunger, a value indicative of a desired change in the patient'"'"'s hunger, a value indicative of the patient'"'"'s appetite, a value indicative of a desired change in the patient'"'"'s appetite, a value indicative of the patient'"'"'s nausea level, a value indicative of a desired change in the patient'"'"'s nausea level, a value indicative of the patient'"'"'s weight, a value indicative of a desired change in the patient'"'"'s weight, a value indicative of an amount of calories consumed by the patient, a value indicative of a desired change in an amount of calories consumed by the patient, a value indicative of an amount of calories expended by the patient, a value indicative of a desired change in an amount of calories expended by the patient, a value for the pulse width, a value for the pulse amplitude, a value for the pulse frequency, a value for a pulse shape, a value for a session duration, a value for a duty cycle, a value for a session frequency, a change in value for the pulse width, a change in value for the pulse amplitude, a change in value for the pulse frequency, a change in value for the pulse shape, a change in value for the session duration, a change in value for the duty cycle, or a change in value for the session frequency, wherein said input is wirelessly transmitted to the transceiver of the electrical stimulation device from the external device.

67. An electrical dermal patch configured to modulate a patient'"'"'s appetite comprising:

a housing adapted to be positioned on the patient'"'"'s skin;

a controller positioned within the housing;

at least one electrode adapted to be in electrical contact with said patient'"'"'s skin;

a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate a plurality of electrical pulses, wherein each of the plurality of electrical pulses are defined by a plurality of stimulation parameters, wherein the plurality of stimulation parameters are selected such that the patient'"'"'s appetite modulates from a first state, prior to stimulation, to a second state after stimulation, wherein the housing has a first length extending from one end of the electrical dermal patch to the other end of the electrical dermal patch and has a first width extending from one edge of the electrical dermal patch to the other edge of the electrical dermal patch and wherein the electrical dermal patch generates an electrical field having a length substantially equal to or greater than three times the first length and a width substantially equal to or greater than the first width.

68. An electrical stimulation system configured to modulate a patient'"'"'s appetite comprising:

an electrical dermal patch adapted to be adhered to the patient'"'"'s skin, wherein said electrical dermal patch comprises a controller, at least one electrode adapted to be in electrical contact with the patient'"'"'s skin, a pulse generator in electrical communication with the controller and said at least one electrode; and

a transceiver in communication with at least one of said controller or pulse generator; and

a plurality of programmatic instructions, stored in a non-transient computer readable memory of a device physically separate from said electrical dermal patch, wherein, when executed, said programmatic instructions acquire patient status data, generate a modulation signal based upon said patient status data, wherein said modulation signal comprises instructions for modulating at least one of a pulse width, a pulse amplitude, a pulse frequency, a pulse shape, a duty cycle, a session duration, or a session frequency, and cause said modulation signal to be wirelessly transmitted from the device to the transceiver.

69. The electrical stimulation system of claim 68 wherein the pulse generator is configured to generate a plurality of electrical pulses and a corresponding electrical field, wherein the electrical field is adapted to penetrate a range of 0.1 mm to 25 mm through the patient'"'"'s skin.

70. The electrical stimulation system of claim 69 wherein the electrical field is adapted to contact at least one of the patient'"'"'s T2 frontal and lateral thoracic dermatome, T3 frontal and lateral thoracic dermatome, T4 frontal and lateral thoracic dermatome, T5 frontal and lateral thoracic dermatome, T6 frontal and lateral thoracic dermatome, T7 frontal and lateral thoracic dermatome, T8 frontal and lateral thoracic dermatome, T9 frontal and lateral thoracic dermatome, or T10 frontal and lateral thoracic dermatome.

71. The electrical stimulation system of claim 69 wherein the electrical field is adapted to contact at least one of the patient'"'"'s T2 frontal and lateral thoracic dermatome, T3 frontal and lateral thoracic dermatome, T4 frontal and lateral thoracic dermatome, T5 frontal and lateral thoracic dermatome, T6 frontal and lateral thoracic dermatome, T7 frontal and lateral thoracic dermatome, T8 frontal and lateral thoracic dermatome, T9 frontal and lateral thoracic dermatome, or T10 frontal and lateral thoracic dermatome and is not positioned within a range of 0.1 mm to 25 mm from any one of the patient'"'"'s T2 posterior thoracic dermatome, T3 posterior thoracic dermatome, T4 posterior thoracic dermatome, T5 posterior thoracic dermatome, T6 posterior thoracic dermatome, T7 posterior thoracic dermatome, T8 posterior thoracic dermatome, T9 posterior thoracic dermatome, and T10 posterior thoracic dermatome.

72. The electrical stimulation system of claim 69 wherein the electrical field is adapted to contact at least one of the patient'"'"'s C8 anterior or posterior dermatome located on the patient'"'"'s hand, wrist, elbow, and fingers, C8 anterior or posterior dermatome located on the patient'"'"'s arm, C8 dermatome located on the patient'"'"'s upper trunk, T1 anterior or posterior dermatome located on the patient'"'"'s arm, T1 anterior or posterior dermatome located on the patient'"'"'s wrist, elbow, and hand, or T1 anterior or posterior dermatome located on the patient'"'"'s upper trunk is electrically stimulated.

73. The electrical stimulation system of claim 68 wherein the plurality of electrical pulses comprise a pulse width in a range of 10 μ

sec to 100 msec, a pulse amplitude in a range of 100 μ

A to 500 mA, and a pulse frequency in a range of 1 Hz to 10,000 Hz.

74. The electrical stimulation system of claim 68 wherein said patient status data comprises at least one of the patient'"'"'s hunger, the patient'"'"'s hunger appetite, the patient'"'"'s satiety level, the patient'"'"'s satiation level, or a degree of well-being experienced by the patient.

75. The electrical stimulation system of claim 74 wherein said well-being comprises at least one of a degree of nausea being experienced by the patient or a degree of dyspepsia being experienced by the patient.

76. The electrical stimulation system of claim 68 wherein, when executed, said programmatic instructions acquire a first stimulation protocol and use said first stimulation protocol to generate the modulation signal.

77. The electrical stimulation system of claim 76 wherein, when executed, said programmatic instructions acquire a second stimulation protocol, wherein said second stimulation protocol is different from the first stimulation protocol, and, using said second stimulation protocol, generate a second modulation signal, wherein said second modulation signal comprises instructions for modulating at least one of the pulse width, the pulse amplitude, the pulse frequency, the pulse shape, the duty cycle, the session duration, or the session frequency.

78. The electrical stimulation system of claim 77 wherein, when executed, said programmatic instructions wirelessly transmit said second modulation signal from the device to the electrical dermal patch.

79. The electrical stimulation system of claim 78 wherein the electrical dermal patch is configured to use the second modulation signal to modify at least one of said pulse width, pulse amplitude, pulse frequency, pulse shape, duty cycle, session duration, or session frequency to yield a second pulse width, a second pulse amplitude, a second pulse frequency, a second pulse shape, a second duty cycle, a second session duration, or a second session frequency, wherein at least one of the second pulse width is different from the first pulse width, the second pulse amplitude is different from the first pulse amplitude, the second pulse frequency is different from the first pulse frequency, the second pulse shape is different from the first pulse shape, the second duty cycle is different from the first duty cycle, the second session duration is different from the first session duration, or the second session frequency is different from the first session frequency.

80. The electrical stimulation system of claim 68 wherein said controller, pulse generator, and transceiver are positioned in a first housing and the at least one electrode is positioned outside said first housing.

81. The electrical stimulation system of claim 68 further comprising a hydrogel pad having a top surface and a bottom surface, wherein the top surface is in electrical communication with the at least one electrode.

82. The electrical stimulation system of claim 81 further comprising an adhesive layer positioned on the bottom surface of the hydrogel pad.

83. The electrical stimulation system of claim 82 wherein, when the adhesive layer of the electrical dermal patch is adhered to the patient'"'"'s skin, the electrical dermal patch has an average minimum peel strength in a range of 1.3 to 1.7 newtons.

84. The electrical stimulation system of claim 68 wherein at least one of said pulse width, said pulse amplitude, or said pulse frequency are defined such that, after receiving at least one stimulation session, the appetite of said patient is less than the appetite of said patient prior to receiving said at least one stimulation session.

85. The electrical stimulation system of claim 68 wherein at least one of said pulse width, said pulse amplitude, or said pulse frequency are defined such that, after at least one stimulation, the patient'"'"'s appetite decreases, over a predefined period of time, relative to the patient'"'"'s appetite before stimulation and a nausea level of the patient does not increase, over said predefined period of time, relative to the nausea level of the patient before stimulation.

86. The electrical stimulation system of claim 68 wherein at least one of said pulse width, said pulse amplitude, or said pulse frequency are defined such that, after at least one stimulation, the patient'"'"'s appetite decreases, over a predefined period of time, relative to the patient'"'"'s appetite before stimulation, wherein at least one of a dyspepsia level of the patient or a nausea level of the patient does not increase, over said predefined period of time, relative to at least one of the dyspepsia level or the nausea level of the patient before stimulation, and wherein said at least one stimulation does not cause the patient to experience a pain sensation.

87. The electrical stimulation system of claim 68 wherein at least one of said pulse width, said pulse amplitude, or said pulse frequency are defined such that, after at least one stimulation, the patient'"'"'s appetite decreases, over a predefined period of time, relative to the patient'"'"'s appetite before stimulation and a nausea level of the patient does not increase by more than 10%, over said predefined period of time, relative to the nausea level of the patient before stimulation.

88. The electrical stimulation system of claim 68 wherein the electrical dermal patch further comprises a housing and wherein the controller and the pulse generator are located within the housing.

89. The electrical stimulation system of claim 88 wherein at least a portion of said housing is covered by at least one polymer having a hardness measure of 30-70 on a subzero shore scale.

90. The electrical stimulation system of claim 88 wherein at least a portion of said housing is encased in at least one polymer having a tensile modulus of 15 to 55 psi.

91. The electrical stimulation system of claim 88 further comprising a circuit board positioned within said housing, wherein the controller and the pulse generator are positioned on the circuit board and wherein the circuit board has a maximum area of 5 in².

92. The electrical stimulation system of claim 91 wherein the circuit board comprises a dielectric laminate having no more than three layers and having a thickness no greater than 0.05 inches.

93. The electrical stimulation system of claim 88 wherein the housing has a substantially linear profile, a width of 4 inches or less, a length of 8 inches or less, and a height of 1 inches or less.

94. The electrical stimulation system of claim 68 wherein the electrical dermal patch has a volume in a range of 0.25 in³ to 10 in³.

95. The electrical stimulation system of claim 68 wherein the electrical dermal patch has a weight in a range of 15 grams to 250 grams.

96. The electrical stimulation system of claim 68 wherein the electrical dermal patch further comprises a power source.

97. The electrical stimulation system of claim 96 wherein said power source is two stacked batteries having a voltage in a range of 1.0 V to 8.0 V.

98. The electrical stimulation system of claim 68 wherein the electrical dermal patch has an ingress protection rating of at least IPX4.

99. The electrical stimulation system of claim 68 wherein the electrical dermal patch further comprises an impedance sensor configured to determine an electrode integrity of the at least one electrode.

100. The electrical stimulation system of claim 68 wherein the pulse generator is configured to generate a plurality of electrical pulses and a corresponding electrical field, wherein the electrical field is adapted to contact at least one of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, or T12 dermatomes.

101. The electrical stimulation system of claim 68 wherein the pulse generator is configured to generate a plurality of electrical pulses and a corresponding electrical field, wherein the electrical field is adapted to contact a portion of at least one of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, or T12 frontal and lateral dermatomes and wherein the electrical field is not adapted to contact any portion of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 posterior dermatomes.