CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of, and priority to, U.S. Provisional Patent Application No. 63/341,295, filed May 12, 2022, the contents of which are hereby incorporated by reference herein in their entireties.

FIELD OF THE INVENTION

[0002] The present invention relates generally to nerve stimulation therapy, such as percutaneous posterior tibial nerve stimulation (PTNS) therapy, and, more specifically, to a wireless PTNS therapy device and system for providing nerve stimulation therapy.

BACKGROUND OF THE INVENTION

[0003] Percutaneous posterior tibial nerve stimulation (PTNS) therapy in its current iteration is recommended as a third-line therapy conjointly by the urological and uro- gynaecological society of Australia and New Zealand for non-neurogenic over-active bladder (OAB) and by the American Society of Colon and Rectal Surgeons for fecal incontinence (FI), respectively. PTNS therapy stimulates the afferent and efferent pathways from the bowel and bladder to the brain. Central control of micturition and defecation is normalized resulting in reduced symptoms of urinary and fecal incontinence. Normal micturition and defecation require complex neural coordination with the spinal cord and brain. Afferent pathways convey sensory information on distension and efferent motor pathways respond to preserve voluntary control. Dysfunction of the afferent neural pathways alters the balance of inhibitory and excitatory stimuli leading to increased efferent signaling and compromising voluntary control of micturition and defecation. PTNS therapy modulates the abnormal involuntary reflexes of the lower urinary tract and lower bowel, restoring voluntary continence control.

[0004] However, PTNS therapy currently requires a clinician to insert a fine needle (e.g., 34 gauge) at the site of the posterior tibial nerve of a patient in an out-patient clinical setting. Thereafter, the needle stimulates the tibial nerve for about 30 minutes. This treatment occurs once every week for 12 weeks, followed by maintenance treatment of one 30 minutes session per month for 12 months. Inaccurate placement of the percutaneous needle may result in non- activation or non-effective stimulation or both of the posterior tibial nerve resulting in poor therapeutic outcomes. Other limitations to the current iteration of PTNS therapy include the cost (e.g., $800 per course of treatment), labor intensive for both patient and clinician/physician, non-adherence, and administration burdens.

[0005] Accordingly, the present disclosure provides solutions to address the above and other problems.

SUMMARY OF THE INVENTION

[0006] According to one embodiment of the present disclosure, a device includes a substrate with a bottom surface and a top surface opposite from the bottom surface. The bottom surface has an adhesive configured to adhere the substrate to skin of a user. The device further includes a first electrode on the bottom surface of the substrate. The device further includes a second electrode on the bottom surface of the substrate and spaced apart from the first electrode. The device further includes a power receiver circuit attached to the substrate and configured to wirelessly receive power. The power receiver circuit is electrically connected to the first electrode and the second electrode.

[0007] Aspects of the embodiment include each microneedle array of the first microneedle array electrode is configured to percutaneously penetrate to the epidermis of the skin of the user, with the bottom surface of the device affixed to the skin of the user. Additional aspects of the embodiment include the first microneedle array electrode is circumscribed by the second electrode. Additional aspects of the embodiment include the second electrode being formed of anodes positioned around a circumference of the first microneedle array electrode.

[0008] Additional aspects of the embodiment include each microneedle of the first microneedle array electrode being 500 to 1200 pm long. Additional aspects of the embodiment include the first microneedle array electrode having 10 to 200 microneedles. Additional aspects of the embodiment include the first microneedle array electrode being 1 cm ² in surface area. Additional aspects of the embodiment include the first microneedle array electrode being circular with a 20 mm diameter. Additional aspects of the embodiment include the substrate including a separate first portion, a separate second portion, and a separate third portion, each having the bottom surface and the top surface, with the first microneedle array electrode on the first portion, with the second electrode on the second portion, and the power receiver circuit on the third portion. Additional aspects of the embodiment include the device further including a controller configured to control the first microneedle array electrode in response to the wirelessly received power. Additional aspects of the embodiment include the controller controlling a frequency, an amplitude, a pulse width, or a combination thereof of one or more electrical pulses of the wirelessly received power to the first microneedle array electrode and the second electrode to provide percutaneous posterior tibial nerve stimulation therapy to the user, with the device located adjacent a posterior tibial never of the user. Additional aspects of the embodiment include the frequency of the one or more electrical pulses ranges from about 0.1 Hz to about 10 kHz, and the wavelength of the one or more electrical pulses ranges from about one microsecond to about tens of seconds. Additional aspects of the embodiment include the pulse width of the one or more electrical pulses is at about 14 to 20 Hz for about 210 microseconds for maintenance therapy regimens, and the pulse width of the one or more electrical pulses is at about 100 kHz for about 100 microseconds for on-demand therapy regimens. Additional aspects of the embodiment include the device including one or more gyroscopes, one or more accelerometers, or a combination thereof. Additional aspects of the embodiment include the second electrode being a microarray needle array electrode or a hydrogel-based electrode. Additional aspects of the embodiment include the selected afferent nerve is selected from the group consisting of a tibial nerve, a saphenous nerve, a sciatic nerve, a lumbosacral nerve, or a sacral nerves.

[0009] According to another embodiment of the present disclosure, a system is disclosed that includes a stimulation device and power transmission device. The stimulation device includes a substrate with a bottom surface and a top surface opposite from the bottom surface. The bottom surface has an adhesive configured to adhere the substrate to skin of a user. The stimulation device further includes a first microneedle array electrode on the bottom surface of the substrate. The stimulation device further includes a second electrode on the bottom surface of the substrate, spaced apart from the first microneedle array electrode. The stimulation device further includes a power receiver circuit attached to the substrate and configured to wirelessly receiver power. The power receiver circuit is electrically connected to the first microneedle array electrode and the second electrode. The power transmission device includes a power transmission circuit configured to wirelessly transmit power to the power receiver circuit. The power transmission device further includes a controller configured to control the transmission of the power from the power transmission circuit to the power receiver circuit. The power transmission device further includes a body configured to hold the power transmission circuit and the controller.

[0010] Aspects of the embodiment include the substrate having a separate first portion, a separate second portion, and a separate third portion. Each portion has the bottom surface and the top surface. The first microneedle array electrode is on the first portion. The second electrode is on the second portion. The power receiver circuit is on the third portion. Aspects of the embodiment further include the system having a cord configured to electrically connect to a power source for providing the power to the power transmission circuit for transmitting to the power receiver circuit. Aspects of the embodiment further include the system having a battery configured to store the power until transmission to the power receiver circuit by the power transmission circuit. Aspects of the embodiment further include the controller controlling a frequency, an amplitude, a pulse width, or a combination thereof of one or more electrical pulses of the wirelessly received power to the first microneedle array electrode and the second electrode to provide percutaneous posterior tibial nerve stimulation therapy to the user, with the stimulation device located adjacent a posterior tibial nerve of the user. Aspects of the embodiment further include the system having one or more gyroscopes, one or more accelerometers, or a combination thereof.

[0011] According to another embodiment of the present disclosure, a method of providing percutaneous posterior tibial nerve stimulation therapy is disclosed. The method includes transmitting power wirelessly from a power transmission circuit of a power transmission device. The method further includes receiving the power wirelessly at a power receiver circuit of a stimulation device. The method further includes generating, based on power, one or more electrical pulses at a first microneedle array electrode of the stimulation device and at a second electrode of the stimulation device, spaced apart from the first microneedle array electrode, with the stimulation device affixed adjacent a posterior tibial nerve of a user and the first microneedle array electrode and the second electrode in electrical contact with skin of the user. Aspects of the embodiment include controlling a frequency, an amplitude, a pulse width, or a combination thereof of the one or more electrical pulses with a controller.

[0012] Aspects of the embodiment further include the controller being located on the power transmission device. Aspects of the embodiment further include the controller being located on the stimulation device. Aspects of the embodiment further include the generating the one or more electrical pulses occurring on-demand in response to receiving a command at the power transmission device for providing the percutaneous posterior tibial nerve stimulation therapy. Aspects of the embodiment further include the generating the one or more electrical pulses occurring continuously during a pre-determined period of time for providing the percutaneous posterior tibial nerve stimulation therapy. Aspects of the embodiment further include the generating the one or more electrical pulses occurring periodically during the pre- determined period of time for providing the percutaneous posterior tibial nerve stimulation therapy.

[0013] According to another embodiment of the present disclosure, a neuromodulator system is disclosed that includes a stimulation device configured to modulate afferent nerve signaling to the central nervous system of a user. The neuromodulator system further includes a controller in communication with the stimulation device. The controller is configured to determine activity state information of the user over a period of time based, at least in part, on historical movement data from one or more sensors associated with the user; predict timing of nocturnal changes in user activity based on the activity state information; and trigger the stimulation device based, at least in part, on the predicted timing of the nocturnal changes to modulate the afferent nerve signaling for preventing nocturia symptoms.

[0014] Aspects of the embodiment include the stimulation device having an adhesive element configured to adhere to the user. The adhesive element contains one or more electrodes. According to some aspects, the one or more electrodes can include 2 to 72 electrodes. Alternatively, according to some aspects, the one or more electrodes can be up to 120 electrodes, or even up to 240 electrodes, or even more. Additional aspects of the embodiment include the one or more electrodes being configured to provide signals to the central nervous system of the user for modulating the afferent nerve signaling. Additional aspects of the embodiment include the adhesive element being configured to adhere to skin of a user for greater than 12 hours. Additional aspects of the embodiment include the one or more sensors being one or more gyroscopes, one or more accelerometers, or a combination thereof attached to the user, attached to a bed associated with the user, or a combination thereof. Additional aspects of the embodiment include the one or more sensors being configured to detect and/or receive impedance and/or current usage from one or more external devices associated with the user that indicate movement of the user. Additional aspects of the embodiment include the controller triggering the stimulation device based, at least in part, on current movement data from the one or more sensors associated with the user to modulate the afferent nerve signaling for preventing nocturia symptoms. Additional aspects of the embodiment include the controller triggering the stimulation device during a period of low current movement data and prior to the predicted timing of the nocturnal changes. Additional aspects of the embodiment include the controller being within a smart device separate from the stimulation device. Additional aspects of the embodiment include the smart device being a wearable device attached to the user. [0015] According to another embodiment of the present disclosure, a neuromodulator system is disclosed that includes a stimulation device configured to modulate afferent nerve signaling to the central nervous system of a user. The device further includes a controller in communication with the stimulation device. The controller is configured to: trigger the stimulation device to provide a maintenance therapy regimen at a regular intervals by modulating afferent nerve signaling to the central nervous system; trigger the stimulation device to provide an on-demand therapy regimen, for a duration shorter than the maintenance therapy regimen, by modulating afferent nerve signaling to the central nervous system, wherein the on-demand therapy regimen is triggered based on an input from the user; and limit usage of the on-demand therapy regimen based, at least in part, on being within a threshold period of time from modulating the afferent nerve signaling during the maintenance therapy regimen, the on-demand therapy regimen, or a combination thereof.

[0016] Aspects of the embodiment include the stimulation device including an adhesive element configured to adhere to the user, the adhesive element containing one or more electrodes. According to some aspects, the one or more electrodes can include 2 to 72 electrodes. Alternatively, according to some aspects, the one or more electrodes can be up to 120 electrodes, or even up to 240 electrodes, or even more. Aspects of the embodiment include the one or more electrodes being configured to provide signals to the central nervous system of the user for modulating the afferent nerve signaling. Aspects of the embodiment include the adhesive element being configured to adhere to skin of a user for greater than 12 hours. Aspects of the embodiment include the controller being within a smart device separate from the stimulation device.

[0017] Additional aspects of the disclosure will be apparent to those of ordinary skill in the art in view of the detailed description of various embodiments, which is made with reference to the drawings, a brief description of which is provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 shows a plan view of a stimulation device, according to one embodiment.

[0019] FIG. 2 shows a perspective view of a microneedle array electrode, according to one embodiment.

[0020] FIG. 3 shows a perspective view of a stimulation device, according to another embodiment. [0021] FIG. 4 shows a side view of a stimulation device on a user, according to one embodiment.

[0022] FIG. 5 shows a top view of a user wearing a stimulation device relative to a power transmission device, according to one embodiment.

[0023] While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION

[0024] The device and system of the present disclosure include a wearable and minimally invasive nerve stimulation device for one or more legs of a user, that can modulate afferent nerve signaling for the treatment of various diseases and conditions associated with nerve signaling. According to specific aspects, the device and system of the present disclosure include a percutaneous posterior tibial nerve stimulation (PTNS) device that reduces a user’s symptoms of urinary incontinence and faecal incontinence.

[0025] The stimulation devices of the present disclosure can include one or more microneedle array electrodes that allow for accurate and consistent delivery of nerve signaling treatment, such as to the posterior tibial nerve of the user. The systems of the present disclosure include a power transmission device to transmit power to the stimulation device for generating the stimulation. According to some aspects, the power transmission device can transmit power wirelessly to the stimulation device or through a physical medium, such as a wire or the skin of a user. The power transmission device can be positioned in a variety of locations relative to the user to transmit power to the stimulation device affixed to the patient. Locations includes being positioned on an article of clothing; furniture, such as a bed; work spaces; etc. for transmitting power to the stimulation device affixed to the patient. According to some aspects, the power being transmitted wirelessly may be preferred depending of the location of the power transmission device, such as its proximity to the user.

[0026] The microneedle array electrode percutaneously penetrates to the level of the epidermis of the patient, rather than further down to the subcutaneous layer. This allows the microneedle array electrode to reduce the likelihood of adverse complications of a deep single needle penetration to subcutaneous muscle layers where it can cause pain, bleeding, and bruising at the site of the insertion. Thus, the microneedle array electrode generally eliminates the need for a clinician to administer PTNS therapy to a user. Instead, the user can perform self-care outside of a clinical setting, which significantly minimizes for the user the cost and burden of therapy, labor, and administration making, PTNS therapy more accessible to incontinent users.

[0027] According to some implementations, the stimulation device is capable of generating about 0.1 to about 12.0 milliamps (mA) of current, at a frequency of about 0.1 Hertz (Hz) to about 120 kilohertz (kHz), and a pulse width of about 200 microseconds (pm) to about 570 milliseconds (ms). One or more of the current, the frequency, and the pulse width can vary depending on various factors, such as the age and weight of the user; the desired stimulation, such as continuous, periodic, or on-demand stimulation; and the like, as discussed further below. According to some implementations, the frequency can be controlled to minimize and/or eliminate paresthesia at site of stimulation. For example, electrical pulses at the higher frequency range, or around 120 kHz can be applied, which can minimize and/or eliminate paresthesia.

[0028] The stimulation device provides pulses of electrical stimulation to the user with the microneedle array electrode. According to some implementations, the microneedles within the microneedle array electrode can be wholly, partially, or separately stimulated or programmed to enable focal targeting and steering of electro-magnetic fields to achieve specific fascicle of peripheral nerves, including the posterior tibial nerve. According to some implementations, each microneedle array electrode can include 1 to 72 microneedles. Alternatively, according to some aspects, each microneedle array electrode can include up to 120 microneedles, or even up to 240 microneedles, or even more. Further, according to some implementations, each microneedle and/or groups of microneedles with the microneedle array electrode can be configured to act separately or in combination with as separate electrodes.

[0029] According to some implementations, the stimulation can be on-demand, such as in the case of an on-demand therapy regimen; periodic over a period of time, such as in the case of a partial maintenance therapy regimen; or continuously for a period of time, such as in the case of a continuous maintenance therapy regimen. On-demand treatment can be for situations when the user is feeling an acute case of incontinence. Periodic or continuous treatment over a period of time can be for the continuous management of chronic symptoms of incontinence. The period of time of treatment can be varied for example, monthly, weekly, throughout the day, while the patient is awake, while the patient is asleep, or for smaller periods while asleep or awake.

[0030] According to some implementations, the penetration depth of the microneedle array electrode can be determined. The depth of penetration can be controlled by the length of needles, incorporation of a spacer, such as an elastic membrane behind the needles, or a combination thereof. With respect to use of the elastic membrane, the membrane can control depth as a function of the spring constant of the elastic material. A lower spring constant will reduce the depth of penetration, while a higher spring concentration will increase it proportionally.

[0031] According to some implementations, the microneedle array electrode can reduce the inductance of the stimulation circuit by 60% in resistance measured in Ohms, as required to achieve sensory and/or motor activation from stimulation of the posterior tibial nerve compared to transcutaneous electrical stimulation form a hydrogel electrode. This reduces power consumption and enables higher frequency stimulation.

[0032] According to some implementations, the systems and methods disclosed herein can be based on a closed loop feedback configuration. In the case of urinary incontinence, such a configuration can be based on lower urinary tract symptom biomarkers, such as, for example, inflammation/infection biomarkers associated with overactive bladder. These include, for example, the C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and procalcitonin levels. However, the biomarkers can be any type of biomarker related to bladder control, such as chemical bio-markers; neural bio-markers, including changes to EMG wave patterns; or other coupled sensor data that can relate to issues with bladder control, including, for example, heart/pulse rate, blood pressure, blood oxygenation, sleep cycle, accelerometer data, and gyroscope data. For systems and methods used to treat other nerve signaling pathways, along with their associated physiological conditions, the symptom biomarkers can be the same or different biomarkers disclosed above.

[0033] According to some aspects, the devices and systems of the invention can be used to prophylactically trigger neurostimulation to reduce urgent signals that would cause the patient to wake up. In other words, the devices and systems can provide stimulation before a patient would ordinarily have to get out of bed in response to symptoms. This stimulation delays that waking response thus allowing the patient to increase the number of hours of un-interrupted sleep. Such stimulation can be reduced to prevent or reduce the likelihood of the stimulation causing the patient to wake up or causing discomfort in certain situation. For example, the stimulation may change depending on the patient’s activity (e.g., lying down, standing, siting, etc.) or a determining activity (e.g., giving a speed, based on an extended period of standing; riding in a car, based on an extended period of sitting; or asleep, based on an extended period of lying down). In some situations the stimulation can be increased so that the patient can mildly feel the stimulation. The ability to feel the stimulation may increase the effectiveness of the stimulation based on the psychological effects of knowing that treatment has started, and that relief may be soon expected.

[0034] FIG. 1 shows a plan view of a stimulation device 100, according to one embodiment. The stimulation device 100 is configured to be positioned with respect to a user’s posterior tibial nerve for electrically stimulating the tibial nerve for alleviating incontinence conditions of the user. The device 100 includes a substrate 102 with a bottom surface 104 and a top surface (not shown), opposite from the first surface 104. The substrate 102 can be any type of flexible or semi-flexible substrate that can adhere to skin of a user. For example, the substrate 102 can be a bandage that can adhere and substantially conform to skin of a user. The substrate 102 is further thick enough to retain the below-described components of the device 100, either within the substrate 102 or on one of the surfaces (e.g., surface 104) of the substrate 102 or both.

[0035] According to some implementations, the bottom surface 104, or the top surface, or both, can include an adhesive. The adhesive allows for the substrate 102 to stick to a surface, such as the skin of a user wearing the device 100. The adhesive can be any type of skin-safe adhesive substance, including a gel. The adhesive can allow the stimulation device 100 to adhere to a user for the desired treatment time of, for example, at least one minute, for multiple stimulations, to from 1 hour to 24 hours, or even longer, depending on treatment times determined by a medical professional.

[0036] The device 100 further includes a cathode 106 and an anode 108. According to some aspects, the cathode 106 can is a first microneedle array electrode. The anode 108 also can be a second microneedle array electrode 108. Alternatively, the cathode 106 or the anode 108 can be any other type of electrode, such as a hydrogel -based electrode, where at least the anode 108 or the cathode 106 is a first microneedle array electrode. For purposes of convenience, the cathode 106 will be described below as a first microneedle array electrode, and the anode 108 will be described below as a second microneedle array electrode. Further, although shown as the first microneedle array electrode 106 being the cathode and the second microneedle array electrode 108 being the anode, the locations can be reversed.

[0037] The first microneedle array electrode 106 and the second microneedle array electrode 108 are on the bottom surface 104 of the substrate 102 such that, when the device 100 is affixed to skin of a user using the adhesive on the bottom surface 104, the first microneedle array electrode 106 and the second microneedle array electrode 108 make electrical contact with the skin of the user. Alternatively, the first microneedle array electrode 106 and the second microneedle array electrode 108 can be partially within the substrate 102 but extending therethrough so as to make electrical contact with the skin of the user. Such electrical contact constitutes the electrodes 106 and 108 percutaneously penetrating the skin, as further discussed below, to provide the nerve stimulation discussed herein.

[0038] Each of the first microneedle array electrode 106 and the second microneedle array electrode 108 includes an array of microneedles, as further disclosed below with respect to FIG. 2. One of the first microneedle array electrode 106 and the second microneedle array electrode 108 is arranged on the bottom surface of the substrate to be located superior to at least a portion of a user’s posterior tibial nerve, and the other of the first microneedle array electrode 106 and the second microneedle array electrode 108 is arranged on the bottom surface of the substrate to be separated from the other. According to some implementations, one of the electrodes 106 and 108 locates superior to the posterior tibial nerve and between a medial malleolus and an Achilles tendon of the patient.

[0039] The device 100 further includes a power receiver circuit 110 attached to the substrate 102. The circuit 110 is configured to wirelessly receive power, such as through induction power transmission. According to some implementations, the circuit 110 is a metal induction coil. The circuit 110 is electrically connected to the first microneedle array electrode 106 and the second microneedle array electrode 108. Accordingly, the circuit 110 can provide electrical power to the first microneedle array electrode 106 and the second microneedle array electrode 108.

[0040] According to some implementations, the device 100 further includes a controller 112 that is electrically connected to the first microneedle array electrode 106, the second microneedle array electrode 108, and the circuit 110. The controller 112 is configured to control the application of power from the circuit 110 to the first microneedle array electrode 106 and the second microneedle array electrode 108, as further disclosed below with respect to FIG. 2.

[0041] According to some implementations, the device 100 can further include one or more accelerometers 114, one or more gyroscopes 116, or both. The accelerometer(s) 114 and gyroscope(s) 116 can provide information for when and how to apply power to one or more of the first microneedle array electrode 106 and the second microneedle array electrode 108 for providing the nerve stimulation therapy. For example, the accelerometer(s) 114 and gyroscope(s) 116 can provide data for the controller 112 to determine a desirable amplitude and/or frequency for maximizing the nerve stimulation therapy.

[0042] According to some implementations, data from the accelerometer(s) 114 and gyroscope(s) 116 provides the ability to monitor or learn a user’s sleeping patterns and trigger stimulation. Nocturia events coincide with increased levels of movement and body positioning change. One or more movement and/or positioning thresholds can be set during sleeping hours to provide the ability to trigger acute stimulation at sub-sensory and/or sensory thresholds to mitigate the onset of nocturia event. Further, the one or more movement and/or positioning thresholds can be preset or sent by monitoring a user’s sleeping patterns.

[0043] FIG. 2 shows a perspective view of a microneedle array electrode 200, according to one embodiment. The microneedle array electrode 200 is an example of a structure of the first microneedle array electrode 106 and the second microneedle array electrode 108 in FIG. 1. Although shown as having a circular shape, the electrode 200 can have various different shapes, such as triangular, square, rectangular, etc.

[0044] The electrode 200 includes a plurality of microneedles 202 that form an array 204. Each microneedle 202 is configured to percutaneously penetrate to the epidermis of the skin of a user when the microneedle array electrode 200 is affixed to the skin of the user. According to some embodiments, each microneedle 202 is about 200 micrometers (pm) to about 1200 pm long, including about 500 to about 1200 pm long, such as about 800 pm. Accordingly, the microneedle array electrode 200 pierces only through about 50 pm to 1000 pm, or more preferably about 200 pm to about 800 pm, of the skin going through the stratum corneum layer of the skin of the user. This does not trigger a pain response for the user because no pain receptors are contacted. The microneedle array electrode 200 also does not penetrate deep enough to draw blood.

[0045] The array 204 can include 1 to about 240 or more microneedles 202, such as about 8, or 72, or 120 microneedles 202. The surface area of the array 204 can be about 0.1 square centimeter (cm ² ) to about 2 cm ² , such as about 1 cm ² . The array 204 can be about 1 mm to about 20 mm in diameter, such as about 10 mm. The microneedles 202 can be formed of any skin-safe, conductive material, such as stainless steel, gold, silver, nitinol, platinum, magnesium, carbon nanotubes, polyaniline (PANI), polyacetylene, polythiophene, polyphenylene sulfide, Polyprrole (PPV), Poly(3,4-ethylenedi oxythiophene), poly(hexylthiophene), poly(fluorene), polyphenylenes, polypyrenes, polyazulenes, polynapthalenes, polyacetylenes (PAC), Poly(p-Phenylene vinylene) (PPV), polycarazoles, polyindoles, polythiophenes, and poly(p-phenylene sulfide).

[0046] According to some implementations, the plurality of microneedles 202 can be electrically connected such that all are simultaneously activated by power from a power receiver circuit (e.g., power receiver circuit 110) so as to form and act as a single electrode. Alternatively, groups microneedles 202 or even individual microneedles 202 within the array 204 can be wired so that they are separately activated by power from a power receiver circuit. For example, and referring back to FIG. 1, according to some implementations, the controller 112 can independently activate one or more of the microneedles of the first microneedle array electrode 106 and the second microneedle array electrode 108 to provide focal targeting and to steer electro-magnetic fields to specific fascicle of peripheral nerves, including the posterior tibial nerve.

[0047] According to some implementations, different sections of the array 204 and the respective microneedles can form a cathode and other section of the array 204 and the respective microneedles can form an anode. Thus, according to some implementations, a single microneedle array electrode can form both the cathode and the anode. Methods to form such an electrode are known, as disclosed in, for example, Guvanasen et al., IEEE Transactions on Neural Systems and Rehabilitation Engineering 25.9 (2016): 1440-1452, the contents of which are hereby incorporated by reference herein in their entirety.

[0048] According to some implementations, around the circumference 206 of the array 204 can be positioned one or more electrodes, such as metal pads or a metal ring (not shown) that each or together form an electrode. In which case, the microneedles 202 within the array 204 can form the cathode. In such an arrangement, the array 204 acting as the cathode is circumscribed by the second electrode acting as the anode. Alternative, the array 204 can be the anode, which is circumscribed by the second electrode acting as the cathode.

[0049] Referring back to FIG. 1, the power transmitted to the first microneedle array electrode 106 and the second microneedle array electrode 108 results in a series of pulses of electrical stimulation. Each pulse has a frequency, a wavelength, an amplitude, and, optionally, a delay between adjacent pulses. According to some implementations, the pulses of electrical stimulation can all have the same frequency, amplitude, or both. According to some implementations, one or both of the frequency and the amplitude can vary between one or more pulses. According to some implementations, the frequency can be about 0.1 Hz to about 120 kHz, the amplitude can be about 0.1 mA to about 12.0 mA for the pulses, and the pulse widths can be about 10 pm to about 570 milliseconds (ms). For instances of electrical stimulation for chromic stimulation, the frequency can be about 5 Hz to about 100 Hz and the wavelength can be about 210 ms to about 540 ms. For instances of electrical stimulation for acute stimulation, the frequency can be about 10 kHz and above and the wavelength can be about 1.5 seconds to about 2 seconds.

[0050] FIG. 3 shows a perspective view of a stimulation device 300, according to another embodiment. The device 300 is similar to the device 100 disclosed above. Therefore, elements in FIG. 3 with similar ones and tens digit numbering as used in FIG. 1 are identical, except as otherwise disclosed below. Specifically, instead of being a single piece, the substrate of the device 300 is instead three separate portions 302a, 302b, and 302c of substrate. Each portion 302a, 302b, and 302c includes the same bottom (304) and top (not shown, opposite of bottom surface 304) surfaces discussed above, with the bottom surface 304 including an adhesive. The portion 302a includes the power receiver circuit, which is within the portion 302a and, therefore, not visible. The portion 302a can also include a controller (e.g., controller 112), one or more accelerometers (e.g., accelerometer(s) 114), and one or more gyroscopes (e.g., gyroscope(s) 116), if present. The portion 302b includes a first microneedle array electrode 306, and the portion 302c includes the second microneedle array electrode 308. The first microneedle array electrode 306 and the second microneedle array electrode 308 are electrically connected to the power receiver circuit in the portion 302a by wires 316.

[0051] According to some implementations, the separate portions 302a, 302b, and 302c of the substrate of the device 300 allow for greater flexibility in positioning the portions 302b and 302c relative to the nerve of the user as compared to the device 100. According to some implementations, the separate portions 302a, 302b, and 302c of the substrate of the device 300 allow for greater flexibility in positioning the power receiver circuit in the portion 302a relative to a power transmission circuit, discussed below. Each of the first microneedle array electrode 306 and the second microneedle array electrode 308 can be a single electrode, as described above. Alternatively, the first microneedle array electrode 306 can be configured as a cathode and an anode by separately controlling the associated array of microneedles. Similarly, the second microneedle array electrode 308 can be configured as a cathode and an anode by separately controlling the associated array of microneedles. Although only two portions are shown with corresponding electrode, i.e., portions 302b and 302c, alternatively, the device 300 can have up to four portions, with each portion being configured as a single electrode or as both a cathode and an anode. According to some implementations, the electrode of the portions may be another type of electrode besides a microneedle array electrode, such as a metal contact pad or a hydrogel-based electrode and the like. The ability to have more portions with additional electrode allows for electro-shaping through the manipulation of cathode and anode combinations. Further, this configuration allows for interferential and orthodox stimulation paradigm. For example, there can be interferential stimulation (two fields interfering with each other) such that the same patch is sometimes a cathode and sometimes an anode.

[0052] FIG. 4 shows a side view of a stimulation device 400 attached to a user’s left foot 402, according to one implementation. Although shown generally appearing as the device 100 of FIG. 1, the device 400 can be the stimulation device 100 of FIG. 1 or the stimulation device 300 of FIG. 3. The device 400 is positioned on the user 402 to stimulate the tibial nerve located in the foot of the user 402. The profile of the device 400, such as its thickness of about 1 millimeter to about 2 centimeters, allows for the device 400 to be placed and remain on the user 402 during various activities. Stimulation can be applied to the tibial nerve 404 of the user 402 with the device 400 by applying wireless power transmission to the device 400 and pulses of electrical stimulation to the electrodes (e.g., electrodes 106/108). The user 402 can be performing various activities and have power transmitted via various power transmissions schemes. For example, the user 402 can be wearing a sock or footwear that has a complementary power transmission device. Alternatively, the user 402 may not be wearing a covering on the foot, but the device 400, and power can be transmitted by a power transmission device in proximity to the user, such as on a surface near the user’s bed or couch, or on or under the covers of the user’s bed while the user 402 is on the bed, as further disclosed below with respect to FIG. 5.

[0053] Specifically, FIG. 5 shows a top view of a user 402 wearing the stimulation device 400 while lying on a power transmission device 500, according to one embodiment. Specifically, the power transmission device 500 can include a mattress 502 that the user 402 lies on, such as while the user 402 sleeps. The mattress 502 can contain a power transmission circuit 504 that is configured to wirelessly transmit power to the power receiver circuit of the stimulation device 400 worn by the user 402. The mattress 502 can further contain a controller 506 that controls transmission of the power from the power transmission circuit 504 to the stimulation device 400. In implementations where the stimulation device 400 does not include a controller, the controller 506 can further control application of the wirelessly transmitted power to the specific microneedle array electrodes of the stimulation device 400.

[0054] According to some implementations, the controller 506 can include a wireless transceiver for receiving commands from a user device 508, such as a mobile phone or control unit. A user can, therefore, control the application of power to the device 400 through the user device 508. For example, the user can instruct the device 400 to provide continuous, periodic, or on-demand stimulation of the microneedle array electrodes of the stimulation device 400 through transmission of one or more commands from the user device 508 to the controller 506, as represented by the arrows 509. Although described as a mobile phone, any device capable of sending commands to the controller 506 can be used, such as any computing device, any smart device, etc.

[0055] With the power transmission device 500 of FIG. 5 located on a mattress, the user 402 can receive PTNS therapy while the user sleeps, such as continuous or periodic PTNS therapy during sleep as part of a maintenance therapy regimen. Alternatively, or in addition, the user 402 can also receive on-demand PTNS therapy by triggering the same user device, such as if the user 402 wakes up with the sudden urge to go to the bathroom, as part of an on- demand therapy regimen. In any situation, the controller 506 can control the transmission of power and the application of the power for the stimulation by the device 400, to alleviate the urgency of going to the bathroom.

[0056] Continuous or periodic PTNS therapy during sleep with the power transmission device 500 can treat chronic incontinence issues, and on-demand PTNS therapy upon waking up can also help alleviate urgent or sudden incontinence issues. Moreover, the wireless transmission of power from the power transmission device 500 to the stimulation device 400 allows the user 402 to have a more natural sleep experience with only the stimulation device 400 affixed to the user 402. Thus, the additional bulk of a power supply is not present because the power is wirelessly transmitted to the stimulation device 400.

[0057] According to some implementations, the power transmission device 500 can include a cord 510 that connects to an electrical power source, such as an electrical outlet. The power transmission device 500 can then receive power from the electrical outlet. Alternatively, or in addition, element 510 in FIG. 5 instead can be a battery located in the power transmission device 500 that stores electrical energy. Power transmitted to the stimulation device 400 can then come from the battery.

[0058] Although the power transmission device 500 in FIG. 5 is illustrated as having generally one power transmission circuit 504, the power transmission device 500 instead can have a plurality of power transmission circuits 504. For example, there may be a plurality of smaller power transmission circuits 504 arranged on the mattress 502. The controller 506 can detect a location of the device 400 with respect to the power transmission device 500 and, more specifically, the power transmission circuits 504 arranged about the power transmission device 500. Such a detection can be achieved by individually powering the power transmission circuits 504 and determining which power transmission circuit 504 is in closest proximity to the device 400. In which case, the controller 506 can select one power transmission circuit 504, among the plurality of power transmission circuits 504, by which to transmit power to the device 400. Accordingly, this arrangement allows for a more localized power transfer/communication across a wider area despite the location of the device 400 within the area being unknown. Other means of detecting the location of 400 may be used.

[0059] As disclosed above, although the power transmission device 500 is shown as being located on a non-wearable surface, such as a mattress, alternatively the power transmission device 500 can be located on wearable items such as a sock, footwear, clothing, etc., such that the power transmission device 500 includes some body that contains the power transmission circuit 504, the controller 506, and a power source, such as the cord/battery 510.

[0060] Further, and as discussed above, the device and system of the present disclosure can be applied to a user for alleviating symptoms associated with OAB and FI. However, the device and system of the present disclosure can be applied to a user for alleviating other conditions. For example, the device can be applied to the pelvis for persistent or chronic pelvic pain, applied adjacent to the bladder for interstitial cystitis (painful bladder syndrome), or applied near the anus for chronic anal fissures, along with being applied to other areas of the both for treating neurogenic urinary incontinence, sexual function, and muscle recovery (e.g., antiinflammatory and increase micro-vascularization).

[0061] According to some implementations, the controller 506 or the controller of the device 400 (e.g., controller 112) can act as a neuromodulator system. The device 400 can provide the afferent nerve signaling, such as to the central nervous system of a user, such as the lumbosacral nerve plexus or the sacral nerve plexus of the user. The controller 506 can perform functions associated with triggering the stimulation. For example, the controller 506 can be configured to determine activity state information of the user. Such activity state information can generally describe the activity of the user, such as standing, sitting, lying down, walking running, etc. The activity state information can be instantaneous (“real time”), or generated over a period of time based, at least in part, on historical movement data. The movement data can be from one or more sensors associated with the user. The one or more sensors can be the one or more accelerometers 114, one or more gyroscopes 116, or a combination thereof within the device 400, as described above. Alternatively, there may be one or more sensors 510 within the immediate environment of the user 402, such as located on mattress 502 or otherwise located within the immediate environment of the user, and able to detect activity of the user 402. According to some implementations, the one or more sensors 510 can be configured to detect and/or receive impedance and/or current usage from one or more external devices associated with the user 402 that indicate movement of the user. For example, the sensors 510 can be embedded within the one or more external devices, or be in communication with the one or more external devices. Such external devices can be, for example, a toilet seat or lid, a sink, a light switch, a bathroom scale, a coffee maker, a water dispenser, etc., which can indicate that the user is out of bed and moving around.

[0062] According to some implementations, and specific to alleviating nighttime occurrences of urgency to use the bathroom, the controller 506 can predict timing of nocturnal changes in user activity based on the activity state information. For example, the controller 506 can detect patterns in nighttime movements or changes in movements that relate to nocturia symptoms. In some cases, a person may have restless sleep prior to feeling the urge to go to the bathroom, which wakes the person. In which case, the controller 506 can predict the timing of such nocturnal changes and related nocturia symptoms.

[0063] Once predicted, the controller 506 can trigger the stimulation device 400 based, at least in part, on the predicted timing of the nocturnal changes to modulate the afferent nerve signaling for preventing nocturia symptoms. Such stimulation can be provided to the central nervous system of the user for modulating the afferent nerve signaling. According to specific implementations, the stimulation can be to the lumbosacral nerve plexus or the sacral nerve plexus. The controller 506 can trigger the device 400 during a period of low current movement data and prior to the predicted timing of the nocturnal changes. For example, the user 402 may be generally still, and therefore be associated with low current movement data generated by the sensors. However, the predicted timing may indicate an imminent urgency to go to the bathroom. In which case, the controller 506 can trigger stimulation during the period of low current movement data.

[0064] According to some implementations, the controller 506 or controller 112 can control functionality of the device 400 to form a neuromodulator system that provides a maintenance therapy regimen and also allows for an on-demand therapy regimen. For example, the controller (e.g., controller 506 or controller 112) can trigger the stimulation device 400 to provide a maintenance therapy regimen at regular intervals by modulating afferent nerve signaling to the central nervous system, including the lumbosacral verve plexus and/or the sacral nerve plexus. This provides steady alleviation for the potential urgency to go to the bathroom. Further, the controller (e.g., controller 506 or controller 112) can trigger the stimulation device 400 to provide an on-demand therapy regimen, which can be of a duration shorter than the maintenance therapy regimen, by modulating afferent nerve signaling to the central nervous system. The on-demand therapy regimen can be triggered based on input from the user 402. For example, the user 402 can use the user device 508 to trigger an on-demand therapy regimen. This provides immediate alleviation for sudden urgent feelings of needing to go to the bathroom. According to some implementations, to avoid over stimulation by the user, the controller (e.g., controller 506 or controller 112) can further limit usage of the on-demand therapy regimen by, at least in part, establishing a pre-determined threshold period of time from the user triggering the afferent nerve signaling during the maintenance therapy regimen, the on-demand therapy regimen, or a combination thereof. As such, the device400 is limited from providing over stimulation, which may be harmful and/or reduce the efficacy of the nerve stimulation.

[0065] The slim form factor of the device as disclosed allows for long-term positioning (e.g., up to 7 days) for automated daily chronic stimulation. This allows for patients to set and forget the device without daily compliance to activate therapeutic stimulation. At the same time, the device of the present disclosure allows for on-demand stimulation through a user- activated digital application (“APP”) to provide abortive stimulation to address immediate urgency and frequency symptoms.

[0066] While the present invention has been described with reference to one or more particular embodiments, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present invention. Each of these embodiments and obvious variations thereof is contemplated as falling within the spirit and scope of the invention. It is also contemplated that additional embodiments according to aspects of the present invention may combine any number of features from any of the embodiments described herein.