SYSTEMS, METHODS AND DEVICES FOR PERIPHERAL NEUROMODULATION
In some embodiments, systems and methods can include a wearable device with an electrically conductive skin interface that excites the underlying nerves from a transcutaneous surface stimulator. The device may be sized for a range of user sizes with stimulation electrodes positioned to target the appropriate nerves, such as the peroneal, femoral, saphenous and/or tibial nerves. The stimulation may include burst stimulation, and involve receiving an input relating to autonomic nervous system activity of the patient.
1 . (canceled)
2 . A wearable device for transcutaneous stimulation of a first afferent lower extremity nerve for treating urinary symptoms in a patient, the device comprising:
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,
wherein the device is not configured for implantation within the patient,
wherein the first electrical stimulus comprises burst stimulation.
3 . The wearable device of claim 2 , further comprising 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 at least one biomedical sensor that, when executed by the processor, cause the device to:
adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information.
4 . The wearable device of claim 2 , wherein the burst stimulation comprises alpha, delta, or theta burst stimulation.
5 . The wearable device of claim 2 , wherein the burst stimulation comprises theta burst stimulation.
6 . The wearable device of claim 2 , wherein the burst stimulation comprises intermittent, intermediate, or continuous theta burst stimulation.
7 . The wearable device of claim 2 , wherein the first electrical stimulus 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.
8 . The wearable device of claim 2 , wherein the first electrical stimulus is stimulatory to the first afferent lower extremity nerve.
9 . The wearable device of claim 2 , wherein the first electrical stimulus is inhibitory to the first afferent lower extremity nerve.
10 . The wearable device of claim 2 , 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.
11 . The wearable device of claim 2 , wherein the first electrical stimulus has a frequency of between about 5 Hz and about 30 Hz.
12 . The wearable device of claim 3 , wherein the feedback information comprises real-time feedback information.
13 . The wearable device of claim 3 , wherein the feedback information comprises autonomic nervous system activity of the patient.
14 . The wearable device of claim 3 , wherein the feedback information comprises heart rate variability.
15 . The wearable device of claim 3 , wherein the feedback information comprises information relating to nocturia events of the patient.
16 . The wearable device of claim 3 , wherein the feedback information comprises information relating to patient sleep state.
17 . A wearable system for treating urinary symptoms in a patient, the system comprising:
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 the first afferent nerve pathway associated with bladder function;
at least one input source configured to provide feedback information;
a stimulator configured to deliver a first electrical stimulus to the 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 a 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.
18 . The wearable system of claim 17 , wherein the first controller and the second controller each comprise a processor and a memory for receiving the feedback information from the input source that, when executed by the processor, cause the device to:
adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information; and
adjust one or more parameters of the second electrical stimulus based at least in part on the feedback information independent from the first electrical stimulus; and
wherein the first electrical stimulus and the second electrical stimulus both comprise burst stimulation.
19 . The wearable system of claim 17 , wherein the feedback information comprises autonomic nervous system activity of the patient.
20 . The wearable system of claim 17 , wherein the feedback information comprises information relating to nocturia events of the patient.
21 . The wearable system of claim 17 , wherein the feedback information comprises information relating to patient sleep state.