Application US20210101007 AI Biotech/Diagnostics: General Diagnostics

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Cala Health, Inc. | Website | Headquarters: Burlingame, CA

Application US20210101007

Published 2021-04-08

Systems, Methods And Devices For Peripheral Neuromodulation For Treating Diseases Related To Overactive Bladder

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 saphenous and/or tibial nerves. The stimulation could include burst stimulation, and involve 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.

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11 Independent Claims

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: 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.
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: 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.
50. A wearable system for treating urinary symptoms in a patient, the device 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 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: 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.
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: 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 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.
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: 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, 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.
85. A method for treating overactive bladder, comprising: 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.
98. A method for treating overactive bladder, comprising: 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.
112. A method of treating urinary symptoms in a patient with transcutaneous stimulation of an afferent lower extremity nerve, comprising: 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.
131. 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 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.
146. A wearable system for treating urinary symptoms in a patient, the device 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 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.