Application US20210101007

SYSTEMS, METHODS AND DEVICES FOR PERIPHERAL NEUROMODULATION FOR TREATING DISEASES RELATED TO OVERACTIVE BLADDER
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US20210101007

1. A method of treating urinary symptoms in a patient with dual transcutaneous stimulation of a first afferent lower extremity nerve and a second afferent lower extremity nerve, comprising: (8) (8)

positioning a first peripheral nerve effector on the patient's skin to stimulate the first afferent lower extremity nerve of the patient;

positioning a second peripheral nerve effector on the patient's skin to stimulate the second afferent lower extremity nerve of the patient;

delivering a first electrical nerve stimulation signal transcutaneously to the first afferent lower extremity nerve through the first peripheral nerve effector;

delivering a second electrical nerve stimulation signal transcutaneously to the second afferent lower extremity nerve through the second peripheral nerve effector;

receiving an input relating to autonomic nervous system activity of the patient; and

modifying at least one brain or spinal cord autonomic feedback loop relating to bladder function based on the input to balance parasympathetic and sympathetic nervous system activity of the patient,

wherein the method does not utilize any implantable components, and only involves transcutaneous stimulation,

wherein the first electrical stimulation signal and the second electrical stimulation signal comprise burst electrical stimulation signals, wherein the burst electrical stimulation signals induce neural plasticity.

2. The method of claim 1, wherein the burst stimulation signals comprises alpha, delta, or theta burst stimulation. (0)

3. The method of claim 1, wherein the burst stimulation signals comprises theta burst stimulation. (0)

4. The method of claim 1, wherein the burst stimulation signals comprise continuous, intermittent, or intermediate theta burst stimulation. (0)

5. The method of claim 1, wherein the first electrical stimulation comprises a stimulation parameter modulated within a range from a first lower predetermined value to a second higher predetermined value, wherein the stimulation parameter is selected from the group consisting of pulse width, frequency, and amplitude. (0)

6. The method of claim 1, wherein the first electrical stimulation comprises a randomized stimulation parameter selected from the group consisting of: pulse width, frequency, and amplitude. (0)

7. The method of claim 1, wherein the first electrical stimulation signal is stimulatory to the first afferent lower extremity peripheral nerve. (0)

8. The method of claim 1, wherein the first electrical stimulation signal is inhibitory to the first afferent lower extremity peripheral nerve. (0)

9. The method of claim 1, wherein the first electrical stimulation signal is stimulatory to the first afferent lower extremity peripheral nerve, and the second electrical stimulatory signal is inhibitory to the second afferent lower extremity peripheral nerve. (0)

30. A wearable device for dual transcutaneous stimulation of a first afferent lower extremity nerve and a second afferent lower extremity nerve and for treating urinary symptoms in a patient, the device comprising: (10) (9)

a controller;

a first peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate the saphenous nerve;

a second peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate the tibial nerve; and

at least one biomedical sensor or data input source configured to provide feedback information;

wherein the controller comprises a processor and a memory for receiving the feedback information from the sensor that, when executed by the processor, cause the device to:

adjust one or more parameters of a first electrical stimulus and a second electrical stimulus based at least in part on the feedback information; and

deliver the first electrical stimulus to the first afferent lower extremity nerve through the first peripheral nerve effector and deliver the second electrical stimulus to the second afferent lower extremity nerve through the second peripheral nerve effector to reduce urinary symptoms by modifying a brain or spinal cord autonomic feedback loop relating to bladder function and balancing sympathetic nerve and parasympathetic nerve activity,

wherein the device is not configured for implantation within the patient,

wherein the first electrical stimulus and the second electrical stimulus both comprise burst stimulation.

31. The wearable device of claim 30, wherein the burst stimulation comprises theta burst stimulation. (0)

32. The wearable device of claim 30, wherein the burst stimulation comprises continuous theta burst stimulation. (0)

33. The wearable device of claim 30, wherein the burst stimulation comprises intermittent theta burst stimulation. (0)

34. The wearable device of claim 30, wherein the electrical theta burst stimulation comprises intermediate theta burst stimulation. (0)

35. The wearable device of claim 30, wherein the first peripheral nerve effector is not physically connected to the second peripheral nerve effector. (0)

36. The wearable device of claim 30, wherein the first electrical stimulus is stimulatory to the first afferent lower extremity peripheral nerve. (0)

37. The wearable device of claim 30, wherein the first electrical stimulation signal is inhibitory to the first afferent lower extremity peripheral nerve. (0)

38. The wearable device of claim 30, wherein the first electrical stimulation signal is stimulatory to the first afferent lower extremity peripheral nerve, and the second electrical stimulatory signal is inhibitory to the second afferent lower extremity peripheral nerve. (0)

39. The wearable device of claim 30, wherein the device is further configured to deliver a priming electrical nerve stimulus prior to delivering the first electrical stimulus, wherein the priming electrical nerve stimulus is a non-theta burst stimulus. (0)

40. The wearable device of claim 30, wherein the device is further configured to alternating the first electrical nerve stimulation signal to the first afferent lower extremity peripheral nerve and the second peripheral nerve signal to the second afferent lower extremity peripheral nerve. (0)

50. A wearable system for treating urinary symptoms in a patient, the device comprising: (0) (11)

a first controller and a second controller configured to operably communicate with each other, the first controller and the second controller not in physical communication with each other;

a first peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate a first afferent nerve pathway associated with bladder function; and

a second peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate a second afferent nerve pathway associated with bladder function;

at least one input source configured to provide feedback information;

wherein the first controller and the second controller each comprise a processor and a memory for receiving the real-time feedback information from the input source that, when executed by the processor, cause the device to:

adjust one or more parameters of a first electrical stimulus based at least in part on the feedback information;

adjust one or more parameters of a second electrical stimulus based at least in part on the feedback information independent from the first electrical stimulus;

deliver the first electrical stimulus to a first afferent nerve pathway through the first peripheral nerve effector to reduce urinary symptoms by modifying a first brain or spinal cord autonomic feedback loop relating to bladder function; and

deliver the second electrical stimulus to a second afferent nerve pathway through the second peripheral nerve effector to reduce urinary symptoms by modifying a second brain or spinal cord autonomic feedback loop relating to bladder function,

wherein adjusting the one or more parameters of the first electrical stimulus and the second electrical stimulus contributes to balancing sympathetic and parasympathetic nervous system activity,

wherein the first electrical stimulus and the second electrical stimulus both comprise burst stimulation.

51. A method of treating urinary symptoms in a patient with dual transcutaneous stimulation of a first afferent lower extremity nerve and a second afferent lower extremity nerve, comprising: (1) (7)

positioning a first peripheral nerve effector on the patient's skin to stimulate the first afferent lower extremity nerve of the patient;

positioning a second peripheral nerve effector on the patient's skin to stimulate the second afferent lower extremity nerve of the patient;

delivering a first electrical nerve stimulation signal transcutaneously to the first afferent lower extremity nerve through the first peripheral nerve effector;

delivering a second electrical nerve stimulation signal transcutaneously to the second afferent lower extremity nerve through the second peripheral nerve effector;

receiving an input relating to autonomic nervous system activity of the patient,

wherein the input comprises both heart rate variability and electrodermal activity of the patient; and

modifying at least one brain or spinal cord autonomic feedback loop relating to bladder function based on the input to balance parasympathetic and sympathetic nervous system activity of the patient.

52. The method of claim 51, wherein the heart rate variability and electrodermal activity input is received from a wrist-worn device on the patient. (0)

70. A wearable device for dual transcutaneous stimulation of a first afferent lower extremity nerve and a second afferent lower extremity nerve and for treating urinary symptoms in a patient, the device comprising: (1) (8)

a controller;

a first peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate the first afferent lower extremity nerve;

a second peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate the second afferent lower extremity nerve; and

at least one biomedical sensor or data input source configured to provide feedback information, the feedback information comprising autonomic nervous system activity comprising both heart rate variability information and electrodermal activity information of the patient;

wherein the controller comprises a processor and a memory for receiving the feedback information from the sensor that, when executed by the processor, cause the device to:

adjust one or more parameters of a first electrical stimulus and a second electrical stimulus based at least in part on the feedback information; and

wherein the device is not configured for implantation within the patient.

71. The wearable device of claim 70, wherein the first electrical stimulus and the second electrical stimulus both comprise burst stimulation. (1) (0)

84. A method of treating urinary symptoms in a patient with dual stimulation of a first afferent lower extremity nerve and a second afferent lower extremity nerve, comprising: (0) (7)

positioning a first peripheral nerve effector on the patient to stimulate the first afferent lower extremity nerve of the patient;

positioning a second peripheral nerve effector on the patient to stimulate the second afferent lower extremity nerve of the patient;

delivering a first electrical nerve stimulation signal to the first afferent lower extremity nerve through the first peripheral nerve effector;

delivering a second electrical nerve stimulation signal to the second afferent lower extremity nerve through the second peripheral nerve effector;

receiving an input relating to autonomic nervous system activity of the patient; and

modifying at least one brain or spinal cord autonomic feedback loop relating to bladder function based on the input to balance parasympathetic and sympathetic nervous system activity of the patient,

85. A method for treating overactive bladder, comprising: (4) (3)

assessing at least one of sympathetic and parasympathetic activity of a subject and determining the presence of sympathetic or parasympathetic overactivity in the subject;

stimulating a first lower extremity afferent nerve sufficient to have a therapeutic effect on overactive bladder only if abnormal sympathetic activity is present; and

stimulating a second lower extremity afferent nerve sufficient to have a therapeutic effect on overactive bladder only if abnormal parasympathetic activity is present.

86. The method of claim 85, wherein stimulating comprises only electrical transcutaneous stimulation. (0)

87. The method of claim 85, wherein stimulating comprises inhibiting nerve activity of the first lower extremity afferent nerve or the second lower extremity afferent nerve. (0)

88. The method of claim 85, wherein stimulating comprises exciting nerve activity of the first lower extremity afferent nerve or the second lower extremity afferent nerve. (0)

89. The method of claim 85, comprising stimulating both the first lower extremity afferent nerve and the second lower extremity afferent nerve if both abnormal sympathetic activity and abnormal parasympathetic activity are present. (0)

98. A method for treating overactive bladder, comprising: (2) (5)

electrically stimulating a first nerve associated with bladder function;

assessing at least one of sympathetic and parasympathetic activity of a subject and determining the presence or absence of sympathetic or parasympathetic overactivity in the subject;

assessing symptomatology of overactive bladder;

adjusting the electrical stimulation based upon assessing the at least one of sympathetic and parasympathetic activity and the symptomatology of overactive bladder,

wherein adjusting the electrical stimulation comprises identifying sympathetic or parasympathetic overactivity in the patient; discontinuing electrical stimulation of the first nerve associated with bladder function; and initiating electrical stimulation of a second nerve associated with bladder function.

99. The method of claim 98, wherein the first nerve is the saphenous nerve. (0)

100. The method of claim 98, wherein the first nerve is the tibial nerve. (0)

112. A method of treating urinary symptoms in a patient with transcutaneous stimulation of an afferent lower extremity nerve, comprising: (4) (6)

positioning a first peripheral nerve effector on the patient's skin to stimulate the afferent lower extremity nerve of the patient;

delivering a first electrical nerve stimulation signal transcutaneously to the afferent lower extremity nerve through the first peripheral nerve effector;

receiving an input relating to autonomic nervous system activity of the patient; and

modifying at least one brain or spinal cord autonomic feedback loop relating to bladder function based on the input to balance parasympathetic and sympathetic nervous system activity of the patient,

wherein the method does not utilize any implantable components, and only involves transcutaneous stimulation,

wherein the first electrical stimulation signal comprises burst electrical stimulation signals, wherein the burst electrical stimulation signals induce neural plasticity.

113. The method of claim 112, wherein the burst stimulation signals comprises alpha, delta, or theta burst stimulation. (0)

114. The method of claim 112, wherein the burst stimulation signals comprises theta burst stimulation. (0)

115. The method of claim 112, wherein the burst stimulation signals comprise continuous, intermittent, or intermediate theta burst stimulation. (0)

116. The method of claim 112, wherein the first electrical stimulation comprises a stimulation parameter modulated within a range from a first lower predetermined value to a second higher predetermined value, wherein the stimulation parameter is selected from the group consisting of pulse width, frequency, and amplitude. (0)

131. A wearable device for transcutaneous stimulation of a first afferent lower extremity nerve for treating urinary symptoms in a patient, the device comprising: (1) (5)

a controller;

a first peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate a first afferent lower extremity nerve; and

a stimulator configured to deliver a first electrical stimulus to the first afferent lower extremity nerve through the first peripheral nerve effector to reduce urinary symptoms by modifying a brain or spinal cord autonomic feedback loop relating to bladder function and balancing sympathetic nerve and parasympathetic nerve activity,

wherein the device is not configured for implantation within the patient,

wherein the first electrical stimulus comprises burst stimulation.

132. The wearable device of claim 131, further comprising at least one biomedical sensor or data input source configured to provide feedback information; (1) (2)

146. A wearable system for treating urinary symptoms in a patient, the device comprising: (1) (7)

a first controller and a second controller configured to operably communicate with each other, the first controller and the second controller not in physical communication with each other;

a second peripheral nerve effector, comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate the first afferent nerve pathway associated with bladder function;

at least one input source configured to provide feedback information;

a stimulator configured to deliver the first electrical stimulus to a first afferent nerve pathway through the first peripheral nerve effector to reduce urinary symptoms by modifying a first brain or spinal cord autonomic feedback loop relating to bladder function; and deliver the second electrical stimulus to the first afferent nerve pathway through the second peripheral nerve effector to reduce urinary symptoms by modifying the first brain or spinal cord autonomic feedback loop relating to bladder function,

wherein adjusting the one or more parameters of the first electrical stimulus and the second electrical stimulus contributes to balancing sympathetic and parasympathetic nervous system activity,

wherein the first electrical stimulus and the second electrical stimulus both comprise burst stimulation.

147. The wearable system of claim 146, wherein the first controller and the second controller each comprise a processor and a memory for receiving the real-time feedback information from the input source that, when executed by the processor, cause the device to: (0) (2)

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Application US20210101007

SYSTEMS, METHODS AND DEVICES FOR PERIPHERAL NEUROMODULATION FOR TREATING DISEASES RELATED TO OVERACTIVE BLADDER

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