Wearable neurostimulation device and methods of treatment

Abstract

The present invention is a neurostimulation treatment system, device, applicator, and methods of use to provide neurostimulation to a nerve. The device includes a wearable band that attaches to the patient's lower leg and ankle in a location proximate to the posterior tibial nerve. The wearable band includes a housing holding a microneedle electrode array which is extended to pierce the epidermis of the patient's ankle for a treatment session, and a control unit to power neurostimulation. Proper location of the wearable band proximate to the posterior tibial nerve may be assisted by use of a detachable positioning template. The invention includes methods for using the treatment system of the invention, and an applicator and a patient kit.

Description

Title: WEARABLE NEUROSTIMULATION DEVICE AND METHODS OF TREATMENTCountry: United States of AmericaApplicant: Australis Scientific Pty Ltd. Docket No: PMH0002PCTInventors:BREDENKAMP, Johannes Michiel JANSEN VAN VUUREN, Jeanne DU PLESSIS, Andre Jacques JORDAAN, Johannes Petrus AGAHARI, Nicky Pratama JENSEN, Mark Martin DELANEY, Danielle P.WEARABLE NEUROSTIMULATION DEVICE AND METHODS OF TREATMENTFIELD OF THE INVENTION

[0001] The present disclosure relates to wearable neurostimulation devices and methods of use for the treatment of a condition such as urinary incontinence.BACKGROUND OF THE INVENTION

[0002] Incontinence is a common problem, especially in aging individuals, but it can also affect young persons. Incontinence is considered as any involuntary loss of urine (urinary incontinence) or feces (fecal or bowel incontinence). There are varying levels of incontinence that may be experienced by a person, from minor leaks to complete loss of control of the bladder or bowel.

[0003] Incontinence can be embarrassing and inconvenient. Some developments have been made in tibial nerve neuromodulation to treat pelvic floor and gastrointestinal disorders. The tibial nerve is a branch of the sciatic nerve and passes alongside the tibia into the foot. Stimulation of the tibial nerve has been found to block signals from the brain that can trigger incontinence, as well as to strengthen muscles to aid in preventing further episodes of incontinence.

[0004] Typically, for percutaneous neurostimulation of the tibial nerve, a doctor or trained medical professional is required to precisely insert a needle electrode below the epidermis (percutaneously), near the medial malleolus of a patient during an office visit. A second electrode is then positioned above the epidermis. Due to the procedure needing to be performed by a trained medical professional, this form of treatment is relatively costly. Alternatively, an implanted electrode may be positioned near the tibial nerve and energized using a local power cell or by an external power source. Further, due to the procedure being invasive, it can be painful and may result in inflammation and blood loss (which can in turn leave the patient susceptible to bacterial infections). Many patients may simply refuse to go to a doctor’s office to have these devices installed, as they may be afraid or otherwise embarrassed.

[0005] Positioning a needle into the correct location can be challenging, and theseprocedures are typically performed exclusively by trained medical professionals. A patient therefore needs to visit a specialist, typically a urologist, to have the needle inserted. The known devices are also clunky or large, and they can interfere with the patient’s general lifestyle. These larger devices may also be visible, even through the patient’s clothing, which may increase their discomfort or cause embarrassment, further discouraging patients to seek or comply with treatment. Performing a percutaneous treatment procedure requires significant accuracy. If a needle is not positioned accurately, it may require significantly more electrical power to properly stimulate the posterior tibial nerve, for example due to impedance to transfer of electrical current because of the intervening tissue. In circumstances where a patient employs the needles in their own capacity (which is generally not allowed), it can be unhygienic, inaccurate and cause damage to the device or injury to the patient. However, even the trained professional can be susceptible to human error. Human errors include not positioning the needle at a proper location, not applying enough pressure or force to insert the needle and / or applying too much pressure or force when inserting the needle. These human errors can result in ineffective or inefficient treatment, or injury, which may prevent the patient from following up the treatment.

[0006] The preceding discussion of the background to the present disclosure is intended only to facilitate an understanding of the present disclosure. It should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was part of the common general knowledge in the art as at the priority date of the application.SUMMARY OF THE INVENTION

[0007] An implementation of the neurostimulation treatment device of the invention includes a wearable band having an upper surface and a lower surface, where the lower surface contacts the epidermis of a patient’s leg proximate to a posterior tibial nerve. The device includes a housing on the upper surface of the wearable band and encloses a stimulating microneedle electrode array for percutaneously piercing the epidermis on the patient’s ankle to apply neurostimulation to a posterior tibial nerve. The microneedle electrode array is extended from a retracted position in the housing to an extended position from the housing to pierce the patient’s epidermis to applyneurostimulation to the posterior tibial nerve. The treatment device also includes a second electrode located separately from the microneedle electrode array; and a control unit releasably attachable to the upper surface of the wearable band that is operative to deliver an electric current or pulse to the stimulating microneedle electrode array.

[0008] The neurostimulation treatment device may further include a positioning template that is releasably attachable to the upper surface of the wearable band that has a first aperture and a second aperture. The first aperture is sized and shaped to be positioned at a patient’s lateral or medial malleolus (ankle bone) to position the first stimulating microneedle electrode array proximate to the posterior tibial nerve. The second aperture is sized and shaped to receive the housing containing the microneedle electrode array.

[0009] In an implementation of the neurostimulation treatment device the second electrode is a gel electrode.

[0010] In another implementation of the neurostimulation treatment device, an additional microneedle electrode array for stimulating the tibial nerve is at an additional location on the wearable band and is in electrical communication with the control unit.

[0011] In yet another implementation of the neurostimulation treatment device, the microneedle electrode array and the second electrode are supplied with biphasic electrical current during treatment of a patient.

[0012] In another implementation of the neurostimulation treatment device, the control unit includes at least one sensor to detect position or movement of a patient while wearing the treatment device. The control unit may further include a gyroscope, an accelerometer, thermometer, an impedance sensor and / or a voltmeter. The control unit may include a processor, a memory and a recorder, as well as other computer components, to record and transmit data from the wearable band to a remote receiving device that records and evaluates the data received from the control unit. The data received by the remote receiving device may be used to monitor patient compliance with a treatment plan established by a medical professional for the patient’ s use of the device for treatment. The control unit may also include at least one component that receives transmitted data from a remote transmitting device. The transmitted data may adjust at least one parameter of the neurostimulation of the posterior tibial nerve by themicroneedle electrode array. The parameter may be one or more of the duration of stimulation treatment, the type of waveform of the electrical current applied for stimulation of the tibial nerve, either monophasic or biphasic, the frequency of application of the electrical current in a treatment session and the intensity of stimulation applied. The control unit may be programmed to deliver simulation at pre-determined times or on demand when the patient has a sense of urgency to urinate.

[0013] In still another implementation of the neurostimulation treatment device, the lower surface of the wearable band incorporates an adhesive. The wearable band may be configured as a cuff, a strip or a patch, or any configuration that can fit comfortably on a patient’s lower leg and ankle but does not completely surround the leg or ankle.

[0014] In yet another implementation of the neurostimulation treatment device, the housing on the wearable band has a depressible surface in contact with the upper surface of the microneedle electrode array to extend the stimulating microneedle electrode array outward when pressure is applied to the depressible surface. Pressure may be applied by the patient using a finger or thumb extending the microneedles of the electrode array out of the housing to pierce the epidermis of the patient’s ankle proximate to the posterior tibia nerve.

[0015] In another implementation of the neurostimulation treatment device of the invention, the depressible surface of the housing is in contact with the top of a spring that has a bottom in contact with the upper surface of the microneedle electrode that is compressed when the depressible surface is contacted, extending the microneedles of the microneedle electrode array out of the housing to pierce the epidermis of the patient’s ankle when pressure is applied to the depressible surface. An applicator is used to depress the depressible surface extending the microneedles of the array to pierce the epidermis of the patient’s ankle when pressure is applied to the depressible surface.

[0016] An implementation of a method of treating a condition mediated by the tibial nerve of a patient includes applying the neurostimulation treatment device of the invention to a patient’s lower leg and ankle proximate to the posterior tibial nerve, initiating a neurostimulation treatment session by extending the microneedle electrode array to pierce the epidermis proximate to the tibial nerve and providingneurostimulation to the tibial nerve for a sufficient time to inhibit urgency. The patient applies the neurostimulation device to their lower leg and ankle proximate to the posterior tibial nerve and initiates a neurostimulation treatment session to suppress or delay urination when they perceive the need to urinate. The control unit is programmed to initiate treatment at one or more specified times and data from a treatment session is received by the control unit of the neurostimulation treatment device and is transmitted to a remote receiver. The data is then transmitted to a remote receiver is reviewed by a remote medical professional.

[0017] In an implementation of the method of treating a condition mediated by the tibial nerve of a patient using the neurostimulation device of the invention, the patient is provided with an interactive software application for use on a computer that allows the patient to receive instructions for applying and operating the neurostimulation treatment device.

[0018] In another implementation of a method treating a condition mediated by the tibial nerve of a patient, the method includes applying to a patient’s lower leg and ankle the neurostimulation treatment device of the invention for stimulating the posterior tibial nerve, where the treatment device is a wearable band having an upper surface and a lower surface, and the lower surface contacts the epidermis of a patient’s ankle proximate to a posterior tibial nerve, and the treatment device has a housing on the upper surface of the wearable band and is configured to enclose a stimulating microneedle electrode array for percutaneously piercing the epidermis on the patient’s lower leg, and the housing is configured to extend the microneedle electrode array to move from a retracted position in the housing to an extended position from the housing to pierce the patient’s epidermis to apply neurostimulation to the posterior tibial nerve, and the treatment device has a second electrode located separately from the microneedle electrode array and has a control unit releasably attachable to the upper surface of the wearable band that is operative to deliver an electric current or pulse to the stimulating microneedle electrode array, and initiating a neurostimulation treatment session by extending the microneedle electrode array to pierce the epidermis proximate to the tibial nerve, and providing neurostimulation to the tibial nerve for a sufficient time to inhibit urination. The neurostimulation treatment device is positioned on the patient’s lower leg andankle with a positioning template comprising an aperture shaped and sized to receive the patient’s ankle bone and an aperture to allow the top of the housing to extend above the wearable band’s upper surface to locate the microneedle electrode array proximal to the patient’s posterior tibial nerve for neurostimulation.

[0019] hr yet another implementation of a method using the neurostimulation treatment device of the invention, the treatment device is used to treating nocturia by applying to a patient’s lower leg and ankle a neurostimulation treatment device for stimulating the posterior tibial nerve, comprising a wearable band having an upper surface and a lower surface, where the lower surface contacts the epidermis of a patient’s ankle proximate to a posterior tibial nerve, and the wearable band has a housing on the upper surface of the wearable band, the housing configured to enclose a stimulating microneedle electrode array for percutaneously piercing the epidermis on the patient’s lower leg, and the housing is configured to extend the microneedle electrode array to move from a retracted position in the housing to an extended position from the housing to pierce the patient’s epidermis to apply neurostimulation to the posterior tibial nerve, and the treatment device has a second electrode located separately from the microneedle electrode array, and has a control unit releasably attachable to the upper surface of the wearable band that is operative to deliver an electric current or pulse to the stimulating microneedle electrode array. The method includes sensing, recording, reporting and analyzing the patient’s movement and episodes of urination during sleep to predict when episodes of nocturia occur; and structuring a neurostimulation treatment plan for the patient’s use of the neurostimulation treatment device during sleep based on the results of analysis, and the treatment device initiates a treatment session at the predicted times of nocturia.

[0020] In another implementation of the invention, a patient kit for treating incontinence includes at least one wearable band having an upper surface and a lower surface, where the lower surface contacts the epidermis of a patient’s lower leg and ankle proximate to a posterior tibial nerve, the at least one wearable band having a housing on the upper surface of the wearable band, the housing configured to comprise at least one microneedle electrode array for percutaneously piercing the epidermis on the ankle of the patient’s foot to apply neurostimulation to the posterior tibial nerve, andhaving a control unit for providing electrical current to the microneedle electrode array, and having a second electrode located separately from the microneedle electrode array on the at least one wearable band, and having at least one positioning template releasably attachable to the upper surface of the wearable band, the positioning template having a first aperture and a second aperture; where the first aperture is sized and shaped to be positioned at a patient’s lateral or medial malleolus to position the first stimulating microneedle electrode array proximate to the posterior tibial nerve, and wherein the second aperture is sized and shaped to receive the housing containing the control unit on the wearable band. The patient kit may include an applicator for extending the at least one microneedle electrode array and instructions for applying and using the device.

[0021] In an alternative embodiment of a patient kit, the kit includes a wearable band with a housing, control unit, and a releasably attachable template for placement on the lower left leg and ankle of the patient’s foot and a wearable band with a housing, control unit and a releasably attachable template for placement on the lower right leg and ankle of the patient’s foot.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments of the invention, and together with the description, serve to explain the principles of the invention.

[0023] FIGS. 1A-1B are views of an implementation of the treatment device of the invention; FIG. 1A is a top view of the device wearable band having a housing containing the microneedle electrode array and having a control unit for stimulation by the array; and FIG. IB is an exploded view of the device housing and control unit.

[0024] FIGS. 2A-2D are views of the positioning template and the assembled template and wearable band of the treatment device; FIG. 2A is a top view of an implementation of the positioning template for placing the treatment device on a patient’s leg in proximity to the tibial nerve; FIG. 2B depicts the template shown in FIG. 2A in place on the wearable band of the treatment device; and FIG. 2C depicts thetreatment device with the positioning template in place on the wearable band attached to a patient’s lower leg and foot. FIG. 2D depicts the treatment device with the positioning template as well as the applicator that is used to activate the microneedle electrode array.

[0025] FIG. 3 is a cross-section implementation of the housing of the treatment device shown in FIG. IB showing a released biasing spring in contact with the microneedle electrode array which is in a retracted position in the housing.

[0026] FIG. 4 is an enlarged view of an implementation of a microneedle electrode array for use in the treatment device.

[0027] FIGS. 5A-5C are views of an implementation of an applicator for use with the incontinence treatment device of the invention. FIG. 5A is a three-dimensional view of an implementation of an applicator for use with the incontinence treatment device of the invention, having a flanged handle, showing the handle in an extended condition; FIG. 5B is a three-dimensional view of the applicator of FIG. 5A, showing the handle in a collapsed or engaged condition; and FIG. 5C is an exploded three-dimensional view of the c o m p o n e n t s of the applicator of FIG. 5A.

[0028] FIG. 6 is a top view of an implementation of a patient kit containing the components of an implementation of the treatment device of the invention.

[0029] FIG. 7 is an exploded view of an implementation of a charging system for charging the control unit on the wearable band of the treatment device of the invention.

[0030] FIG. 8 is a flow diagram of an implementation of the method of the invention for communicating with the patient using a software application on a mobile device for a treatment session using the treatment device of the invention.

[0031] FIG. 9 are screen shots depictions of an implementation of a mobile application for providing a patient with instructions for assembling and using the treatment device, and for recording information of treatment sessions provided in a software application on a patient’s mobile telephone.DETAILED DESCRIPTION OF THE INVENTION

[0032] In an implementation of the device of the invention for stimulating the posterior nerve, a removable, wearable band has a combination of operably connected components, including a deployable microneedle electrode array to provide proper controlled, electrical, percutaneous stimulation of a patient’s posterior tibial nerve in combination with a positioning template that aids in proper placement of the wearable band and components on the patient’s lower leg and ankle. The wearable band also includes a control unit that carries out the functions of the treatment device. The wearable band of the device partially surrounds the patient’s lower leg and ankle, permitting the patient to move without restriction.

[0033] The methods of the invention permit communication between the patient and a medical professional throughout treatment and include use of a mobile phone, smartwatch, desktop or laptop computer or other form of data reception and transmission. These communications may include, but are not limited to. instructions on proper placement and use of the device, patient responses to questions to enable inquiries regarding the patient’s use of the device and response to treatment permitting monitoring of compliance with a treatment plan and adjustments required in the treatment plan, or parameters of the treatment such as frequency of treatment sessions, duration and intensity of neurostimulation. The patient may also be asked to record and report reductions in their symptoms, for example in a diary or log, that is reviewed by the medical professional.

[0034] Paresthesia effects may occur during use of the device of the invention and can vary between patients receiving the same pulse. To comfortably receive treatment, a patient may need to modify one or more of the pulse parameters to minimize or obviate any paresthesia effects, preferably in consultation with a medical professional. As an example, to determine the specific desired amplitude for a patient, pulses are sent at increasing amplitude until a neural motor response is activated, or until paresthesia is felt in the area surrounding the electrodes. In an implementation of a device and method of the invention, wherein the device performs neuro stimulation using a microneedle electrode array, high frequency pulse modulation of between 3 kilohertz (Khz) to 100 Khz should significantly reduce paresthesia side effects and neural motor activation.These high frequencies can be applied by the control unit in a cycling mode, such that the pulse is applied for between 1 m / s to 2 m / s and then stopped for 1 m / s to 1 m / s. The pulse amplitude is desirably set between 0.1 milliamps (mA) to 12.0 milliamps. These settings can be set with the assistance of a medical professional, or with instructions provided by the medical professional to the patient.

[0035] In an implementation of the invention, the control unit is programmed to monitor electrical impendence levels between the epidermis and the microneedle electrode arrays and to automatically adjust amplitude levels (i.e. based on the resulting levels) to reduce the risk of overstimulation resulting in burns or pain. For example, if only a small area of the microneedle electrode array is providing a pulse with the desired current (e.g. due to electrode deterioration), the control unit will decrease or even cease the pulse.

[0036] In an implementation of the invention, the control unit of the wearable band further includes a gyroscope and an accelerometer configured to output positional data of the patient by measuring orientation and angular velocity of the wearable band. The control unit is configured to evaluate the positional data to determine whether the patient is standing, sitting or lying down. Based on the orientation of the patient, one or more pulse parameters may be adjusted.

[0037] Table 1 provides examples of implementations of the device in which the frequency, pulse width and amplitude parameters of neurostimulation are provided to patients of different ages in the sitting, standing and prone positions. The parameters of neurostimulation will vary according to the patient’s condition and general health. Ranges of the following parameters may be used: a frequency of the electrical current of from approximately 1 to approximately 300 Hz / sec, an amplitude of from approximately 0 milliamps to approximately 30 milliamps, an impedance between approximately 40 ohms to approximately 7 kiloohms. The electricity provided for neurostimulation can be monophasic or biphasic. Biphasic has been found to improve a patient’s comfort and reduce buildup of ions in the tissue surrounding the site of stimulation. Monophasic stimulation may provide additional intensity to stimulate an otherwise less sensitive tibial nerve site.Table 1

[0038] Referring now to the drawings, like components are marked throughout the specification and drawings with the same reference numerals, respectively. Drawing figures are not necessarily to scale. For example, in certain views, parts may have been exaggerated for purposes of clarity.

[0039] Implementations disclosed herein do not limit the subject matter. Various other components of the devices of the invention may be included and called upon for providing for aspects of the teachings herein. For example, additional materials, combinations of materials and / or omission of materials may be used to provide for added embodiments that are within the scope of the teachings herein.

[0040] The use of the terms “a” and “an” and “the” and similar referents (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. By way of example, “an element” means “one element or more than one element”.

[0041] As used herein, the term “substantially” means to a great or significant extent, but not completely.

[0042] It should also be understood that, in certain methods described herein that include more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited unless the context indicates otherwise. Furthermore, the terms first, second, etc., as used herein are not meant to denote any particular ordering, but simply for convenienceto denote a plurality.

[0043] The terms “comprising”, “having”, “including”, and “ containing” are to be construed as open-ended terms (i.e.. meaning “including, but not limited to”) unless otherwise noted.

[0044] The use of any and all implementations, examples, or an implementation language (e.g.. “such as”), is intended merely to better illustrate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention as used herein.

[0045] The phrase “and / or” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined.

[0046] The phrase “one or more” as used herein, means “at least one”, and thus includes individual components as well as mixtures / combinations of the listed components in any combination.

[0047] As used herein, “optional” or “optionally” means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0048] Throughout the specification and accompanying claims, unless the context requires otherwise, the word “comprise” or variations such as “comprises” or “comprising” will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

[0049] All methods described herein can be performed in a suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or an implementation language {e.g., “such as” or “for example”), is intended merely to better illustrate the invention and does not pose a limitation on the scope of the invention, unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention as used herein. Unless defined otherwise, technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art of this disclosure.

[0050] Furthermore, the disclosure encompasses all variations, combinations, and permutations in which one or more limitations, elements, clauses, and descriptive terms from one or more of the listed claims are introduced into another claim. For example, any claim that is dependent on another claim can be modified to include one or more limitations found in any other claim that is dependent on the same base claim. Where elements are presented as lists, e.g., in Markush group format, each subgroup of the elements is also disclosed, and any element(s) can be removed from the group.

[0051] All statements herein reciting principles, aspects, and embodiments of the disclosure, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure.

[0052] Various other components may be included and called upon for providing for aspects of the teachings herein. For example, additional materials, combinations of materials and / or omission of materials may be used to provide for added embodiments that are within the scope of the teachings herein. Adequacy of any particular element for practice of the teachings herein is to be judged from the perspective of a designer, manufacturer, seller, user, system operator or other similarly interested party, and such limitations are to be perceived according to the standards of the interested party.

[0053] In the disclosure hereof any element expressed as a means for performing a specified function is intended to encompass any way of performing that function including, for example, a) a combination of circuit elements and associated hardware which perform that function or b) software in any form, including, therefore, firmware, microcode or the like as set forth herein, combined with appropriate circuitry for executing that software to perform the function. Applicants thus regard any means which can provide those functionalities as equivalent to those shown herein. No functional language used in claims appended herein is to be construed as invoking 35 U.S.C. § 112(f) interpretations as “means-plus-function” language unless specifically expressed as such by use of the words “means for” or “steps for” within the respectiveclaim.

[0054] When introducing elements of the present invention or the embodiment(s) thereof, the articles “a”, “an”, and “ the” are intended to mean that there are one or more of the elements. Similarly, the adjective “another”, when used to introduce an element, is intended to mean one or more elements. The terms “including” and “having” are intended to be inclusive such that there may be additional elements other than the listed elements. The term “an implementation” is not intended to be construed as a superlative example but merely one of many possible examples.

[0055] The present invention provides a neurostimulation treatment device, also referred to herein as the “treatment device”, and methods for providing neurostimulation to the posterior tibial nerve of a patient to treat incontinence. Placement of the device and neurostimulation treatment sessions are initiated by the patient, in the patient’s home or other locations away from a medical professional’s office. The device includes a wearable band for attachment to the patient that has a control unit for providing electrical current for stimulation to a plurality of microneedles in a microneedle electrode array contained in a housing also on the wearable band. The control unit has components including sensors that record, analyze and transmit patient data from use of the wearable band during treatment sessions. This allows a medical professional to make adjustments as needed to treatment parameters and establish or modify a treatment plan for the patient. The control unit also has components that receive data transmitted remotely from a medical professional or computer. The remotely transmitted data includes software commands to adjust parameters of treatment, as described further below.

[0056] In an implementation, the microneedle electrode array in the treatment device is deployed to pierce the epidermis of the patient’s ankle by the patient by applying pressure to a depressible surface located on the top of the housing, without requiring assistance from a medical professional. In an alternative implementation the patient uses an applicator to deploy the array.

[0057] The device also includes a positioning template that permits accurate placement of the wearable band on the patient’s lower leg and ankle using the medial malleolus (“ankle bone”). In an implementation, the treatment device is provided in a patient kit for each treatment session that includes the treatment device, an applicatorand additional supplies, as well as instructions for applying and using the device.

[0058] In an implementation, the patient may be guided in the placement and use of the device by using a mobile software application that may include communication with a cloud database. The patient may, for example, undergo a treatment of 12 weeks, having repetitive 7-day periods of wearing the treatment device.

[0059] When placed by a patient on their lower leg and ankle, the device is discrete and may be kept out of sight in clothing to permit normal activities of the patient, including while sleeping. The device does not encircle or otherwise restrict the patient’s lower leg and ankle. These features, as well as a patient treatment plan and feedback from the patient, for example by providing a “bladder diary” and other usage data regarding urination to a medical professional, allow remote monitoring of the patient’s use of the treatment device and to monitor patient compliance with treatment.

[0060] The treatment device and methods of use are described with reference to FIGS. 1-9. FIG. 1A is a top view of an example of an implementation of the wearable band (10) of the neurostimulation treatment device of the invention for attaching to a patient. The wearable band (10), for example, may be constructed with a material that is flexible, and preferably “breathes,” such as many types of wearable medical bandaging materials, to conform to the region of a patient’s medial malleolus intermediate the patient’s inner ankle bone and the Achilles tendon. The medial malleolus is commonly referenced as the “ankle bone.” The material may be, but is not limited to, melt spun polypropylene, elastic cotton material, urethane films, non-woven polyester fabric, polyester, silicone (polysiloxane), or polyamide material. A biocompatible adhesive may be used on the bottom surface of the wearable band (10) to attach the band (10) to the patient’s lower leg and ankle for a treatment session. The adhesive may be, but is not limited to, acrylic adhesives such as polyacrylic or cyanoacrylate adhesives, a silicone (poly siloxane) adhesive, or may be made of a pres sure- sensitive material such and a polyethylene, styrene-butadiene- styrene (SBS), styrene-ethylene / butylene-styrene (SEBS), styrene-ethylene / propylene (SEP), styrene-isoprene- styrene (SIS) or rubber (e.g., polybutadiene or polyisoprene). The wearable band (10) may also be referred to as a dressing, strip, pad or tape. The wearable band (10) has a housing (12) having cover (14) that contains the microneedle electrode array and has an aperture (16) and a controlunit (18) that contains the circuitry for providing neurostimulation to the patient’s posterior tibial nerve, and components such as sensors for collecting patient treatment data. The structure, components and functions of the housing (14) and the control unit (18) are described in detail below. The wearable band (10) is designed to create increased patient compliance, with a low profile that is readily concealed with clothing such as pants, socks, long dresses, or pyjamas.

[0061] FIG. IB illustrates an implementation of the wearable band (10) depicting exploded views of the structure and components of the housing (12) and the control unit (18) on the wearable band (10). The cover (14) of housing (12) includes an aperture (16) from which a depressible tab (20) protrudes, the housing (12) configured to initiate treatment by extending the microneedle electrode array (28) when the tab (20) is pressed downward by the patient, using their thumb or finger. Alternatively, the patient may use an applicator described further below that depresses the tab (20) and is provided to the patient with the device. The cover (14) of housing (12) lies on the surface of the wearable band (10) over an aperture (22). To better align with the tarsal tunnel, aperture (22) may be sloped at an angle (a) in relation to a major axis of the wearable band. The angle (a) may be from 10° to 45°, or from 15° to 35° or from 15° to 30° or roughly 20°. An angle of a ~ +-20° may be preferable for many patients, but other angles may be selected depending on the location of the patient’s posterior tibial nerve and the location and / or shape of their medial malleolus, their age, gender, body shape and other factors. The angle (a) may be selected to facilitate comfort and accurate location of the housing generally over the posterior tibial nerve.

[0062] Conductive materials such as stainless steel or other metals are used for connections throughout the wearable band (10), where needed, to resist corrosion. In the implementation of the treatment band device shown in FIGS. 1 A and IB, the bottom (24) of the housing (12) is fixed to a support (26) for the depressible tab (20). The support (26) provides a fixed surface. When the tab (20) is pressed by the patient’s finger or thumb, or by an applicator, a downward pressure is applied on the support (26) moving the microneedle electrode array (28) extending the microneedles into a patient’s epidermis to begin treatment and apply neurostimulation to the tibial nerve. In an alternative embodiment, a second microneedle array (not shown) may be placed in ahousing on the upper surface of wearable band (10) to replace a second electrode and is connected to the control unit for making an electrical connection to the patient’s epidermis. The additional array may provide more effective treatment for certain patients by reducing the resistance to electrical current flow in the tissue surrounding the tibial nerve. The cover (14) and bottom (24) of the housing (12) are connected together over aperture (22) with the material of the wearable band (10) clamped between the cover (14) and the bottom (24) of the housing (12). In an implementation, the housing cover (14) fits over the walls (30) of the housing bottom (24). The housing (12) is thus fixed securely to the wearable band (10) to prevent movement of the housing (12) during treatment, for example if the patient’s leg is moving. The housing (12) may be configured such that there is a sound, such as a “click” when the array (28) extends to begin treatment. The housing cover (14) and bottom (24) enclose and protect the microneedle electrode array (28) when it is in retracted position within the housing (12), preventing damage to the microneedle electrode array (28) prior to use.

[0063] Continuing to refer to FIG. IB (right side of figure), control unit (18) rests on the upper surface of wearable band (10). A light guide (31) such as one or more white or colored LEDs, and a light guide cover (32) may also be provided to indicate to a patient status of the device such as flashing to alert the patient that a neurostimulation treatment is in progress or has completed or indicate when the battery is getting low in charge. The control unit (18) may include processing circuitry, a printed circuit board (PCB) (34) and a battery (36). One or more foam seals (38) may be provided to pad the processing circuitry and PCB (34). Magnets (40) may be provided in the bottom (42) of control unit (18) to facilitate secure attachment of the control unit (18) to the wearable band by attaching to magnetic connector (44) having a base plate (46). Connector (44) has openings (57) and (59) that receive protruding pins on magnetic connectors (58) and (61) used to connect electrode (54) and adhesive tape (56) to connector (44). The magnetic pins on connectors (58) and (61) protrude through openings (57) and (59) on connector (44) and enter openings (43) and (45) in the bottom (42) of control unit 18). When the control unit (18) is placed on wearable band (10), the protruding pins of connectors (58) and (61) attract the magnets (40) in the bottom (42) of control unit (18). The use of magnetized components on either side of aperture (52)provides for a stable and strong connection of the control unit (18) to wearable band (10). The wiring (50) from the microneedle electrode array (28) passes through connector (58) through to connect to the battery (36) to provide electrical power to the battery (36). Wiring (50) may be embedded in the material of the wearable band (10) to minimize the dimensions of the control unit (18). The bottom (42) of control unit (18) also has openings (not shown) for the charging system described below referring to FIG. 7.

[0064] The control unit (10) may include a seal or gasket component (48) to render the control unit (10) water resistant, allowing the patient to expose their leg to water, for example taking a shower or bath. Alternatively, the seal or gasket (48) can be removed to provide ventilation of a patient’s epidermis while wearing the device.

[0065] The control unit (18) is easily removed by the patient for recharging. The multi-part construction of control unit (18) provides for ease and thus lower costs of manufacture, while providing waterproof, damage-resistant, and movement-resistant protection of the electrical components, as well as an irreversible assembly that prevents tampering after production. The control unit (18) can be connected in either orientation (right side up or upside down) on the wearable band (10). Due to the biphasic nature of neurostimulation, the device does not rely on a positive or negative electrode. The ability to attach the control unit (18) and connector (44) together through magnetic attraction eliminates the need for fine motor dexterity of the patient during attachment, making the device suitable for patients with limited dexterity. The control unit (18) of the treatment device may contain one or more sensors, including, but limited to one or more of sensing components including, but not limited to a gyroscope, accelerometer, thermometer, impedance sensor and / or a voltmeter to that collect and report data from the patient’s use of the device and transmit the data for analysis by a medical professional to adjust stimulation settings.

[0066] The control unit of the treatment device is configured with components to deliver precise and controlled electrical stimulation that stimulates the posterior tibial nerve of a patient for optimal therapeutic outcomes. The control unit is equipped with electrical circuitry that integrates sensor components such as impedance sensors that read impedance of the patient’s epidermis to the microneedles of themicroneedle electrode array, and additional components such as a gyroscope, thermometer, accelerometer and voltmeter, to register data indicating changes in the position of the patient’s leg, for example when walking or laying down. The gyroscope and accelerometer allow monitoring of the device's orientation and angular velocity, respectively during use by the patient. These data points are recorded and analyzed by the control unit or analyzed by computers in a software application or in a remote cloud database infrastructure. These functions of the treatment device enable the detection of subtle changes in the patient's body position and movement patterns during shifts in posture or physical activities that may impact bladder function and the severity of symptoms associated with Overactive Bladder (OAB). For example, the treatment device identifies specific patient movements that coincide with instances of urgency or urinary incontinence, which may offer valuable insights into potential triggers for OAB symptoms. An impedance sensor in the control unit may be employed to monitor changes in bladder volume or detrusor muscle activity in the bladder involved in urination. The sensor is configured to measure variations in electrical impedance over time, providing real-time feedback of bladder filling and emptying patterns of a patient. In turn, this provides for customization of settings of the treatment device appropriate for the patient's unique physiological responses, leading to improved symptom management and treatment efficacy.

[0067] The presence of an IMU in the control unit also allows the modification of treatment of the patent using the treatment device. For example, in response to data received by the IMU while the patient is walking, running, or engaged in other activities, the amplitude of stimulation may be decreased by comparing acceleration and directional data against pre-established patterns of activity of the patient. This may add an additional element of safety to the patient’s use of the treatment device, by reducing the potential impact of the device on muscle response and nerve perception during activities where there would be an increased risk of a fall. This occurs simultaneously with impedance monitoring, which ensures that during motion of the patient, there is a consistent path for the electrical stimulation to travel. For example, if the impedance exceeds three times the baseline impedance, the device can automatically pause the treatment session. Once the patient ceases the activity that hascaused the impedance to increase, for example by sitting or lying down, the impedance data will show the reduction and resume stimulation.

[0068] In addition, the IMU may enable the prediction of nocturia events by detecting and recording sleep data related to the patient's body movements and posture during sleep. Frequency and intensity of movements of the patient’s body such as changes in sleeping positions, and restless leg movements have been found to be correlated with nocturia episodes. During REM (rapid eye movement) sleep, which is associated with dreaming, there is typically decreased muscle tone and minimal body movement. In contrast, during non-REM sleep, there may be more frequent shifts in body position and muscle activity. Sleep stages can be estimated, providing information about the quality and depth of sleep. Interruption of normal sleep patterns by a pattern of rhythmic acceleration with net directional change, indicative of walking, can be used as a marker of a nocturia event. This is due to a normal pattern of sleep being interrupted by the user walking to the restroom to relieve themselves. Sleep tracking data and IMU data can enable more accurate prediction of future nocturia events, allowing for timely intervention through prophylactic stimulation of the posterior tibial nerve using the treatment device. The effectiveness of the treatment device in preventing nocturia-related “sleepwalking” and improving patient sleep quality is enhanced by this approach.

[0069] In the implementation shown in FIG. IB, the incontinence treatment wearable band (10) may also include a gel electrode (54) on its bottom surface to contact the patient’s epidermis. The gel electrode (54) may be attached to the bottom surface of the wearable band (10) by an adhesive such as a double-sided tape (56) and may be a gel electrode to make electrical connection of the control unit (18) with the epidermis of the patient to serve as a ground or for biphasic electrical pulsing. When the microneedle electrode array (28) is extended to pierce the patient’s epidermis during treatment, the presence of both the microneedle electrode array (28) and the gel electrode (54) completes the electrical circuit across the patient’s ankle, thereby enabling stimulation of the target tibial nerve. The exposed material of the wearable band (10) and a gel electrode (54) may be covered and protected by removable, disposable protective tape or other material which will preserve the adhesive properties of the patchfor application to the epidermis and maintain the sterility of the device prior to use. Magnetized component (58) may be used to connect the wiring (50) of the microneedle electrode array (28) through hole (57) in connector (44) of control unit (18) to secure the gel electrode (54) to the connector (44). In an implementation, the gel electrode (54) may have a short projection (62) that inserts into an aperture (64) in the double-sided tape (56) and then in metal component (61) that fits inside aperture (59) in connector (44). Suitable electrodes for use in devices of the invention include hydrogel electrodes, silver electrodes, platinum electrodes or metal electrodes.

[0070] The control unit of the treatment device is configured with components to deliver precise and controlled electrical stimulation that stimulates the posterior tibial nerve of a patient for optimal therapeutic outcomes. The control unit is equipped with electrical circuitry that integrates sensor components such as impedance sensors that read impedance of the patient’s epidermis to the microneedles of the microneedle electrode array, and additional components such as a gyroscope, thermometer, accelerometer and voltmeter, to register data indicating changes in the position of the patient’s leg, for example when walking or laying down. The gyroscope and accelerometer allow monitoring of the device's orientation and angular velocity, respectively during use by the patient. These data points are recorded and analyzed by the control unit or analyzed by computers in a software application or in a remote cloud database infrastructure. These functions of the treatment device enable the detection of subtle changes in the patient's body position and movement patterns during shifts in posture or physical activities that may impact bladder function and the severity of symptoms associated with Overactive Bladder (OAB). For example, the treatment device identifies specific patient movements that coincide with instances of urgency or urinary incontinence, which may offer valuable insights into potential triggers for OAB symptoms. An impedance sensor in the control unit may be employed to monitor changes in detrusor muscle activity in the bladder involved in urination. The sensor is configured to measure variations in electrical impedance over time, providing real-time feedback of bladder filling and emptying patterns of a patient. The sensor may also be configured to measure the accumulation of interstitial fluid in the patient’s legs. In an older patient with poor circulation, lying down causes the fluid to be redistributed andcleared by the kidney, causing increased urine production and more trips during the night to the restroom. Sensing the change in the patient’s position allows the control unit to initiate a treatment session at the time the patient lies down to increase the bladder volume which delays the need to urinate Sensor readings provide for customization of settings of the treatment device appropriate for the patient's unique physiological responses, leading to improved symptom management and treatment efficacy.

[0071] The control unit may further include an internal monitoring unit (“IMU”) that may serve multiple functions by sensing movement of the patient. The presence of an IMU in the control unit also allows the modification of treatment of the patent using the treatment device. For example, in response to data received by the IMU while the patient is walking, running, or engaged in other activities, the amplitude of stimulation may be decreased by comparing acceleration and directional data against pre- established patterns of activity of the patient. This may add an additional element of safety to the patient’s use of the treatment device, by reducing the potential impact of the device on muscle response and nerve perception during activities where there would be an increased risk of a fall. This occurs simultaneously with impedance monitoring, which ensures that during motion of the patient, there is a consistent path for the electrical stimulation to travel. For example, if the impedance exceeds three times the baseline impedance, the device can automatically pause the treatment session. Once the patients stops the activity that has caused the impedance to increase, for example by sitting or lying down, the impedance data will show the reduction and resume stimulation.

[0072] In addition, the IMU may enable the prediction of nocturia events by detecting and recording sleep data related to the patient's body movements and posture during sleep. Frequency and intensity of movements of the patient’s body such as changes in sleeping positions, and restless leg movements have been found to be correlated with nocturia episodes. During REM (rapid eye movement) sleep, which is associated with dreaming, there is typically decreased muscle tone and minimal body movement. In contrast, during non-REM sleep, there may be more frequent shifts in body position and muscle activity. Sleep stages can be estimated, providing information about the quality and depth of sleep. Interruption of normal sleep patterns by a patternof rhythmic acceleration with net directional change, indicative of walking, can be used as a marker of a nocturia event. This is due to a normal pattern of sleep being interrupted by the user walking to the restroom to relieve themselves. Sleep tracking data and IMU data can enable more accurate prediction of future nocturia events, allowing for timely intervention through prophylactic stimulation of the posterior tibial nerve using the treatment device. The effectiveness of the treatment device in preventing nocturia-related “sleep-walking” and improving patient sleep quality is enhanced by this approach.

[0073] In an implementation to initiate a patient treatment session, a button or switch on the top of control unit is used to send an electrical signal into a processor in the control unit which then obtains the desired stimulation parameters from a memory component in the control unit, or, alternatively the parameters are transmitted to the control unit from a remote computer, or data “cloud.” The control unit processor activates a pulse generator in the control unit which is amplified, and an electrical pulse or current is delivered to electrodes. This allows a patient to quickly initiate an on- demand treatment to delay their need to find a restroom in the event of a sudden occurrence of urinary or fecal urgency.

[0074] The incorporation of sensors to monitor the patient’s body positions during use of the treatment device provides an additional layer of patient safety in use of the device. To mitigate such risks, the control unit of the treatment device can continuously monitor and adjust stimulation parameters based on real-time sensor data, for example from an IMU in the control unit, ensuring or facilitating safe and effective treatment delivery. Failure to do so could result in the neurostimulation treatment affecting the patient’s gait or balance, cause muscle spasms or pain. Before any stimulation is delivered to the patient, impedance reading(s) are taken from the IMU and the impedance sensors in the control unit to verify that the microneedles of the microneedle electrode array have been inserted into the epidermis of the patient’s ankle before sending electricity to the microneedles of the array. This prevents the array from producing electrical stimulation when it is not inserted properly or has become displaced on the patient’s ankle.

[0075] In an implementation of a method of the invention, when a patient hasbeen instructed to perform a body movement that will initiate neurostimulation for a treatment session, the IMU, in combination with the processor in the control unit and the data from the impedance sensors, will initiate treatment by providing electricity to the microneedle electrode array. Responses of the treatment device to identifiable patterns of motion include, but are not limited to, starting or stopping neurostimulation treatment session or altering parameters of stimulation such as increasing or decreasing the intensity or duration of the stimulation. In an implementation when the patient initiates neurostimulation, the patient. The patterns of motion by the patient to start neurostimulation should be atypical of that patient’s normal movement pattern, such as motions made when walking, sitting, jogging, sleeping, or other activity. The data produced from the patient’s motion is interpreted by an application on a connected device, such as a mobile phone, or by the control unit. An example for this type of atypical pattern is the patient heavily stomping their foot a predetermined number of times, because this involves distinct vertical acceleration followed by a sharp de acceleration in a single direction as the foot moves down and contacts the floor. A single repeat of this movement is then used to signal the control unit to end the treatment session. Thus, when the treatment device is applying neurostimulation, the motion together with the sensors determines the action taken by the device. In an alternative implementation, the patient rotates their foot in a clockwise or counterclockwise direction, constituting directional motion at a constant acceleration speed to increase or decrease the intensity of the neurostimulation. Such motion control would enable the patient to initiate a treatment session as needed, as an “acute” treatment session, without having to access a software application on a computer device or reaching for a switch or button on the treatment device. Other motions of the patient’s foot that may be used to discreetly control the device include moving the foot back and forth in the frontal coronal plane (the front and back of the human body), kicking the foot, pivoting on the toe or heel of the foot, plantar flexion, dorsiflexion, heal rotation, and toe rotation. This functionality enables patients to rapidly initiate an on-demand treatment to help manage sudden episodes of urinary or fecal urgency. Additionally, it allows stimulation to be activated at the ankle without the need for the patient to bend over to reach their ankle or access a mobile device, enhancing convenience and patent independence.

[0076] In another implementation, the control unit receives a state change command from a remote source, for example transmitted by a Bluetooth command from the control unit or a mobile device, such as a mobile phone or “smart” watch which has a software application for operation of the treatment device, the control unit will activate neurostimulation.

[0077] Ongoing neurostimulation or initiation of neurostimulation by the treatment device can depend on receipt of a signal from the IMU that the patient is in or continues to remain in body positions where it is safe to continue treatment.

[0078] FIG. 2A is an implementation of a removable positioning template (66) having two apertures - first aperture (68) and second aperture (70). First aperture (68) is shaped and sized to be positioned over the patient’s medial malleolus (ankle bone) to assist in attaching the wearable band of the treatment device to the patient’s lower leg and foot such that the microneedles of the microneedle electrode array are placed at an optimal distance from the posterior tibial nerve. This may be accomplished by providing a radial distance of approximately 3 cm ± 0.5 cm from the center of medial malleolus to the housing (12) (See FIG. 1A). First aperture 68 may include a removable curved strip that enables the patient to enlarge the first aperture 68 if needed to fit a larger ankle bone. Second aperture (70) is shaped and sized to fit over the housing (18) holding the microneedle electrode array on the wearable band (10) of the device described above. The template (66) may be composed of a single use or disposable material such as adhesive tape. The positioning template may have varying dimensions to accommodate different lower leg and foot sizes.

[0079] FIG. 2B illustrates the positioning template (66) over the wearable band (10) of the treatment device, showing second aperture (70) over the control unit (18) and first aperture (68). Tabs (72) are part of covers (not shown) that protect the adhesive of the bottom of the wearable band (10) (See FIG. 1A) before application by the patient to their lower leg and ankle.

[0080] FIG. 2C depicts the assembled treatment device of FIG. 2B in place on the inner side of a patient’s lower left leg and ankle over the medial malleolus, placing the housing (12) containing microneedle electrode array in the proper location proximal to the posterior tibial nerve. Positioning the microneedle electrode array between theankle bone and Achilles tendon is optimal because the posterior tibial nerve is located nearer the surface of the patient’s epidermis, facilitating neurostimulation by an electric current or pulse introduced through the microneedle electrode array. Proper localization of the stimulation by the device may reduce the power usage requirements (required Volts or Amperes) of the electric current or pulse that is provided by the control unit to the microneedle electrode array.

[0081] FIG. 2D shows the assembled treatment device of FIG. 2C in place on the inner side of a patient’s lower left leg and ankle, having the applicator (94) placed over the top of housing (12).

[0082] FIG. 3 is a cross-sectional view taken of an implementation of the housing (12) (See FIG. 1A) of the treatment device containing the microneedle electrode array (74) in a retracted position with a spring (76) to extend the array for a treatment session. The housing (12) is shown attached to a support structure (78) in the housing (12). The support structure (78) is configured to move down the inner walls (80) of the housing (12), for example by means of ridges (not shown) formed on opposite sides of the ends of support structure (78) that fit into corresponding vertical grooves (82) in the inner walls (80) of the housing (12), when a downward pressure is exerted on a depressible tab (not shown) in the top (84) of housing (12) that protrudes through the wearable band as shown in FIG. 1A. Downward pressure may be accomplished, for example, using an applicator as shown in FIG. 5 and described below, or the patient may exert the downward pressure with a thumb or finger.

[0083] Having the microneedle electrode array (74) housed in an opaque material may minimize the visual impact of the microneedles on a patient, including any associated anticipatory anxiety regarding procedures using microneedles. Using this strategy, the entire needle insertion process occurs without the patients seeing the microneedles before and during deployment. This may also reduce patient pain perception and can improve compliance with the treatments, rendering the treatments more acceptable to a broader population. Alternatively, one skilled in the positioning of percutaneous needles in a patient, can position the wearable band on the patient’s foot without using the template (66) on the patient’s foot.

[0084] FIG. 4 shows an enlarged view of an implementation of the microneedleelectrode array (84) of FIG. IB. The array (84) may be formed from a blank of biocompatible metal sheet material, such as surgical stainless steel. The individual microneedles (86) may then be bent to extend away from a planar surface of the microneedle electrode array (84). Fastening structure(s) (88) may be provided on opposite ends of the array (only left fastening structure is shown in FIG. 4) to fasten the array (84) to the support structure in the housing as shown in FIG. 3. The microneedles (86) of the microneedle electrode array (84) extend at least partially beyond an inner surface of the housing of the device so as to be capable of piercing the epidermis of the patient. The microneedles (86) permit epidermis penetration without tearing and allow the microneedles (86) to remain in place during normal stretching of the epidermis caused by the patient’s movement. The microneedles (86) are configured to penetrate the epidermis with little resistance or irritation to the patient. Each of the plurality of microneedles (86) may have a length of roughly 1.2 millimeters, or roughly 0.8 millimeters. Only a portion of each needle may. in some implementations, pierce the patient’s epidermis, and the portion of the needles that pierces the epidermis may be in the region of microns (i.e., less than a millimeter). However, implementations in which the needles penetrate deeper than 1 millimeter are possible. The terms “microneedle” or “microneedle electrode array” may be construed to include configurations with needle lengths or piercing depths of over 1 millimeter, or under 1 millimeter. Piercing the epidermis for neurostimulation may be more effective than transcutaneous stimulation because of the impedance generated by layers of epidermis that must be overcome to reach the target nerve with sufficient intensity. The area below the surface of the epidermis where the microneedles (86) are located during treatment is generally more conductive to electricity. This reduces the impedance that the electrical stimulation must overcome to reach the target tibial nerve with sufficient intensity.

[0085] The ovoid form of the needles in the microneedle electrode array may facilitate conforming to the anatomy of the patient such that the primary axis of the electrode form is articulated around the pivot point of the patient’s malleolus, as positioned by the guide or template. In other words, the electrode remains superior to the nerve to ensure stimulation of the correct nerve occurs. This and other elongated shapes may be able increase the relative degree of freedom in microneedle positioning allowingfor individuals to more reliably place the electrode. This may be due to the primary access of the shape tracing with the tract of the nerve during rotation of the patch about a pivot point.

[0086] FIGS. 5A-5C shows an implementation of an applicator (90) for initiating treatment by depressing the tab on the top of the housing on the wearable band of the device and extending the microneedle electrode array. In FIG. 5A, Applicator (90) is shown in an unlocked condition before use, and in a locked condition in FIG. 5B, after use. Locked means that the punch described below and shown in FIG. 5C is recessed into the applicator and the spring is relaxed and ready for use in a treatment session by the patient. Applicator (90) has a handle (92) and a tube body (94) defining a hollow space therein and has a proximal end (98) and a distal end (100), joined by connector (101). The tube body (94) may also be configured as a single tubular body. Referring to FIG. 5C, , the handle (92) also may have a bolt (96) or similar element that extends within the tube body (94) but does not contact the inner walls of the tube body (94). Lock (102) includes jaws (104) and (106). In this implementation, the applicator (90) includes a biasing spring (108) and a punch (110) to exert pressure when the spring (108) is compressed prior to use. The punch (110) moves up and down the sides inside the hollow space of the tube body (94) between the proximal (96) and distal (98) ends in response to the handle (92) being pulled or pushed by the patient. The applicator (90) is open at the bottom (112) of the distal end to permit the punch (110) to extend and contact the depressible tab (16) on the top of the housing (12) (See FIG. 1A) to extend the microneedle electrode array to initiate a patient treatment session. An extension (114) on punch (110) has an arrowhead shaped configuration (116) formed at its base (114) and a slot (118).

[0087] The applicator (90) is provided to the patient in unlocked condition, with the handle (92) fully collapsed (FIG. 5 A) and the spring (108) relaxed with the punch (110) recessed in the tube body (94). The patient pulls the handle (92) upward out of the tube body (94) as shown in FIG. 5B, and the bolt (96) in handle (92) engages the top end of the slot (118) in extension (114) of the punch (110), pulling the punch (110) upward compressing spring (108). In turn, the spring (108) presses into connector (100) and presses upward against the jaws (104) and (106) of lock (102), causing them to moveoutward and the extension (114) on punch (110) to release the bolt, releasing the spring (108) and punch (110). When released, the spring (108) rapidly moves the punch out of the tube body (94) depressing the depressible tab on top of the housing and extending the microneedle electrode array in the housing into the epidermis of the patient’s foot initiating a treatment session. The applicator (90) may be reused, is patient friendly, and can be readily manufactured using plastic molding or other suitable materials as is known in the art. Other mechanisms for applying pressure to the depressible surface of the housing employing biasing means are known in the art, for example configurations used in self-injection “pens” to introduce pharmaceuticals into patients in a home environment.

[0088] FIG. 6 is an implementation of a patient kit (112) to provide the treatment device and associated components of the invention for both legs of a patient. Disinfectant, for example in the form of isopropyl alcohol wipes (114), may be included to allow the patient to sterilize the target epidermis area for the microneedle electrode array, prior to applying the treatment device. A treatment device and positioning template are provided for inside of the left ankle (116) and inside of the right ankle (118) of the patient to facilitate improved therapeutic results, by alternating neurostimulation of the posterior tibial nerves in both feet of the patient. The device and template are placed together and individually packaged in sterile packaging (not shown). A charging base (120) (FIG. 7) is supplied to charge the control unit (122) of the device. Adhesive wearable bandages (124) may also be provided to cover and protect the site of the microneedle deployment after the treatment device is removed after use. An applicator (126) as described in FIG. 5 is provided to extend the microneedle electrode arrays contained within the housing of each device into the patient’s epidermis to initiate treatment. Instructions for application and use of the device and the other components of the kit are included in the kit (112).

[0089] FIG. 7 shows an implementation of a charging system that may be used in conjunction with the treatment device of the invention to charge the control unit of the device. The charger operates by replenishing the device’s rechargeable battery. A charger (128) has an upper part (130) and a lower part (132) that may be fastened together with metal pins (134) that are seated in receptacles (133) in the lower part (132)of the charger (128). The pegs of the pins (134) enter the openings (131) in the upper part (130) of the charger (128) and enter corresponding openings (See FIG. 1 (43)) in the bottom (See FIG. 1 (42)) of the control unit (18) and contact battery (See FIG. 1 (36)) of the control unit (See FIG. 1, (18)) to charge the battery (See FIG. 1 (36)). The pins (134) may be made from conductive metals such as nickel-plated brass. The charger (128) may be formed from materials such as a durable polycarbonate / acrylonitrile butadiene-styrene (PC / ABS) thermoplastic. A weight (136), for example made of galvanized steel may be included between the upper (130) and lower (132) parts of the charger (128) to facilitate magnetic attachment of the charger (128) to magnets on the bottom of the control unit on the wearable band (not shown). In the implementation of the charger (128) the weight (136) has indentations (137) to accommodate the pins (134) extending from the lower part (132) of the charger (128) to the upper part (130) of the charger (128). Adhesive backed rubber “feet” (138) may be affixed to the bottom of the charger (130) for stability and to dampen vibrations. A Universal Serial Bus Type-C (USB-C) electrical cable (140) is provided to recharge the charger. The end (141) of charger cable (140) enters the bottom (132) of charger (128) in opening (141) where it is held in the charger by retainers (143). The wires in the end (141) of the charger cable (140) are divided out and attached to a circuit board (not shown) to supply power to the bottom of pins (134) seated in receptacles (133). The charger monitors the battery’s charge status and may adjust the charging process, for example by regulating the voltage and current supplied to the battery to prevent overcharging or overheating, which can degrade battery health and thus longevity over time.

[0090] The treatment device may be a disposable, single-use device for an extended period of wear to permit treatment for a week or more, before a replacement is needed. For example, after treatment over a period of 7 days, the incontinence treatment device may be removed and safely discarded. The control unit may be detached, cleaned and reused. When the patient removes the wearable band, it may be folded with the microneedle electrode array on the inside for safe sharps disposal. Replacement microneedle electrode arrays may be provided to the patient, in an implementation where the array is detachable from the support in the housing.Alternatively, the patient receives additional kits containing replacement devices and all associated components as needed.

[0091] The inner and outer parts of the housing may, e.g.. be plastic parts, or injection molded parts that clamp or pinch the adhesive strip between them so that it doesn’t move, i.e., so as to inhibit the microneedles from moving during use. The treatment device provides a discreet and minimally invasive procedure to treat incontinence that is applied and used away from a medical office by the patient, i.e., a need to visit a doctor may be alleviated, since the device is easy to install and apply to the correct location on the patient’s foot near the relevant nerve. This may reduce barriers for patients to access therapy.

[0092] The treatment device should not normally require anesthesia or imaging for delivery of treatment and provides minimal or no major side effects. A minor side effect may occur as transient paraesthesia (a “pins and needles” sensation) at the site of one or more microneedles of the array during stimulation. The device can fit into a patient’s lifestyle. The wearable band and housing may be “set and forget” to deliver therapeutic stimulation when scheduled, for example when the patient goes to sleep, to reduce or treat the need to go to the bathroom during sleep. In addition, the reduced power requirement of the device disclosed herein can decrease the size and / or weight of the overall device making it more comfortable for wear for longer periods of time. A doctor’s prescription may be required or specified in certain countries. A doctor’s prescription may be required or specified in certain territories. The usage of microneedles may be advantageous in jurisdictions or territories where reimbursements may be provided to patients for use of the device and methods of the invention to treat incontinence.

[0093] After conclusion of a treatment session, the user may remove the adhesive wearable band of the device until the next treatment session or may leave the device in place in a “standby” mode until the next programmed treatment session. The patient removes the control unit as needed to re-charge the power. This may be facilitated by the presence of LED lights in or on the control unit to indicate a low battery. (See FIG. IB).

[0094] The invention includes methods of treating a patient for incontinence usingthe treatment device disclosed herein. Therapy sessions may be compliant with a so-called gold standard for percutaneous tibial nerve therapy, providing 30 minutes of therapy once a week. However, because the treatment device has a low form factor and can be discretely worn by the patient outside of a doctor’s office, additional treatment plans are possible. For example, patients can potentially leave the device attached to their leg and ankle for extended periods of time and receive additional therapeutic neurostimulation in response to either internal or external signaling. This can enable stimulation to alleviate acute urinary symptoms in situations discreetly, allowing the patient time to find a restroom while urgency is present after an acute stimulation episode.

[0095] A method of using the treatment device of the invention to initiate a session includes the following steps:

[0096] Step 1. The user disinfects the surface of the epidermis of the lower leg and ankle region of the foot where the wearable band and template of the treatment device will be placed. The client / patient may shave any hair on or around the application site. The area is then exfoliated with a cloth and cleaned with soap and water, then dried thoroughly before applying the treatment device.

[0097] Step 2. Application of the device in the correct position on the patient’s leg is facilitated if the patient is sitting comfortably with their foot in a neutral position. The wearable band with the housing and charged control unit and which may include a gel electrode on the bottom surface of the band, with the positioning template, is attached to the patient’s lower leg and ankle (See FIGS. 2B and 2C). Alternatively, the control unit can be attached to the wearable band after charging. After attachment to the patient’s lower leg and ankle, the template is removed and may be disposed; and

[0098] Step 3. The applicator is placed on the housing unit centered on the depressible surface of the housing containing the microneedle electrode array. (See FIG. 2D). The patient presses the top of the applicator extending the microneedle electrode array to pierce the user’s epidermis proximate to the superior tibial nerve initiating a neurostimulation treatment session. Alternatively, the patient may extend the microneedle array by using a finger or thumb to depress the depressible surface of the housing.

[0099] The present disclosure further includes a method of applying the treatment device using an applicator, that may be provided in a patient kit with the treatment device. The method includes placing the wearable band on the patient’ s lower leg and foot near the posterior tibial nerve and placing the positioning template onto the wearable band, over the patient’s ankle bone and the housing containing the microneedle electrode array locating the microneedle electrode array over the posterior tibial nerve, intermediate the patient’s medial malleolus and Achilles tendon. The method may further include positioning the distal end of the tube body of an applicator over a depressible surface in the housing of the incontinence treatment device. The method may further include locking an extendible punch located in the applicator tube body by moving the lock to its locked condition compressing a spring in the applicator and unlocking the lock to rapidly release the punch to hit the depressible surface of the housing on the wearable band to extend the microneedle electrode array to pierce the patient’s epidermis to stimulate the posterior tibial nerve.

[0100] In some implementations, some or all the functionality of the treatment device may be provided remotely, using computing infrastructure. For example, the patient may be guided through the above steps by a software application on their mobile phone device, as described further below. In an implementation of the invention the above steps are performed with the step of establishing a control interface by connecting the treatment device on the patient’s leg to a digital data transmitting device such as a mobile phone, wearable device, such as a smartwatch, or computer, for example a desktop or laptop computer, or portable tablet that provides parameters of treatment to the control unit of the device. The data may be provided by a software application on the transmitting device. The control interface then initiates the treatment session with the programmed parameters including frequency, intensity and duration of application of neurostimulation. The device of the invention may include components for sensing the response of stimulation and sending the data to a receiving device for analysis, such as a remote data receiving device that is operated and monitored by a medical professional. The transmitted data from the patient from the device may also be sent to a database storage such as a “cloud” database.

[0101] FIG. 8 illustrates use of a mobile software application to enable thepatient to practice the method of the invention. The application commences a one-time verification (142) through a one-time password (“OTP”) (144), accompanied by a consent request for use of biometric data to enable streamlined patient log-in thereafter. The home page (146) functions as the central hub of the application, from which the patient may navigate to the progress page (148), the pair device page (150), and the profile page (152). The progress page (148) is configured to facilitate acquisition of patient symptom data. A quality-of-life evaluation (154) provides a measurable assessment of the impact of the user’s incontinence and overactive bladder (“OAB”) symptoms on quality of life, as well as how the patient’s quality of life changes with ongoing treatment. A bladder diary (156) enables continuous and structured selfreporting of incontinence and OAB events, the collected data serving both to quantify patient improvement and to contribute to broader demographic and clinical research. A symptom questionnaire (158) further supports standardized data collection using an easy-to-understand format. Data acquired from the application functions (154-158 )are securely transmitted to a cloud database (160), which in turn supports a trends display (162) for the patient, providing insight into their current bladder status and progress over time, and simultaneously transmits this data to the clinician portal 164) so that healthcare professionals can remotely monitor patient status and make informed treatment decisions, including treatment modifications. The pair device page (150) guides the patient through instructional and visual aids (166, 168) as well as a test procedure (170), to ensure that stimulation is delivered at the appropriate therapeutic threshold unique to the patient. These stimulation parameters may be adjusted by the patient’s medical professional (172) in response to collected symptom data. Once calibrated, treatment plans (174) are enabled, permitting the patient to undergo chronic treatment delivery (176) for a prescribed duration, or to utilize an on-demand trigger (178) to initiate acute treatment delivery (180) when required. During both treatment formats, a treatment card (182) displays the real-time duration and status of the stimulation session. Data generated by the control unit during both chronic and acute treatments are uploaded to the secure database cloud (160) further informing both the medical professional and the patient regarding treatment efficacy and usage patterns. Upon completion of a chronic treatment session, the application prompts the user to remove the patch (184), afterwhich the system returns to the home page (146) to prepare for subsequent sessions. From the profile page (152), the patient may access device and application settings and technical support (186). as well as detailed device identification specifications (188), ensuring complete transparency and user support within the system.

[0102] A further implementation of the method of use of the treatment device of the invention in a treatment session is shown in FIG. 9, in which the patient communicates with an installed software application on a mobile device or computer such as a laptop or desktop, showing screen shots of an operating software application. As shown in FIG. 9, the mobile application communicates with the control unit on the treatment device to deliver and manage stimulation treatment for the patient. At the login screen (190) the patient signs in using a One-Time Password (“OTP”), with the option to enable bio-authentication for subsequent log-ins. Following authentication, the home page (192) provides an overview of key treatment parameters and is configured to allow navigation to the progress page (194) and the profile page (196). The progress page (194) enables the patient to complete a bladder diary, thereby collecting longitudinal data on symptom progression. The profile page (196) permits editing of personal information, access to device details, settings, and technical support, ensuring that the user has visibility into both hardware and software aspects of the system. Next, the patient answers questions for bladder evaluation (198). When the user is ready to initiate stimulation treatment, the application prompts pairing of the control unit to the mobile device by scanning a unique “QR code” (200) provided with the device, for example in the instructions that are provided with the patient kit. The application then guides the user through visual and written instructions for correct application of the treatment device (202). Proper placement of the device (202) is verified through a stimulation test (204). which confirms that sensation is perceived at a specified level in the appropriate regions of the patient’s foot. The patient is then prompted to capture a pre-treatment image of the device (206) applied to the lower leg and ankle, providing visual confirmation of correct placement. Once these steps are complete, a treatment session is initiated, generating data for review by remote healthcare professionals. During the stimulation session, the application displays a treatment card (208), which indicates both the elapsed and then total treatment time. The treatment may be temporarily paused andresumed by the patient selecting the option in the treatment card (210). Upon completion of the session, the application displays a treatment session completion screen (212), thereby notifying the patient that the treatment session has successfully concluded.

[0103] Use of a mobile software application facilitates patient engagement and commitment to treatment by tracking the patient’s usage over time, for example, to determine compliance with a treatment plan, and to identify any problems with use of the device so they can be addressed.

[0104] One notable feature of the application may be its ability to leverage collected data to deliver personalized feedback and encouragement to users. Through notifications or messages sent directly to the user's device or phone, patients are informed of improvements in their symptoms over time. This feedback is derived from a bladder function index marker, which encompasses parameters such as frequency, urgency, and volume, providing patients with tangible evidence of their progress and motivating them to continue their therapeutic regimen. In essence, the application may serve as a supportive companion on the patient's treatment journey, leveraging data-driven insights and positive reinforcement mechanisms to promote adherence and optimize therapeutic outcomes. This allows healthcare providers to remotely monitor patient progress, track stimulation effectiveness, and ensure therapy adherence. By leveraging cloud-based data storage and analysis, the platform facilitates real-time insights and informed decision-making, ultimately enhancing patient outcomes and satisfaction.

[0105] Moreover, the application may incorporate advanced stimulation features designed to ensure correct stimulation parameters and therapy optimization. Additionally, users can have access to a data questionnaire enabling them to provide feedback and insights regarding their therapy experience, further enhancing treatment customization and efficacy.

[0106] Additional iterations within the application can provide digital guidance and promote behavioral intervention for OAB guidance on conducting pelvic floor exercises, instruction on fluid intake, dietary modification, and bladder training. Using the methods of the invention, the patient is given feedback from the neurostimulation and learns to initiate a treatment session when they feel the need to urinate delaying avisit to a bathroom. By repeatedly delaying and deferring urination the bladder , over time, may establish longer periods of delayed urination. The application encourages the desirable behavioral changes by providing educational resources, progress tracking, positive behavioral reinforcement, and community support-connected care.

[0107] Throughout the treatment session, the patient and a healthcare professional can monitor the treatment device's usage and the patient’s response to treatment by viewing information received from the control unit, either in real time, or from saved summary data. Information in the form of digital data, for example including, but not limited to the impedance encountered, treatment start and stop times, responses to therapy parameters including, but not limited to amperage, voltage, duty cycle, frequency, acceleration, specific force, and orientation, can be sent to the software application on the patient’s computer, smartwatch, mobile phone or other device, then stored on a server, for example in a cloud infrastructure. This data may then be correlated with data collected from the patient by the software application, including a bladder diary, quality of life questionnaires, and whether behavioral therapies such as floor exercises are being performed by the patient, etc. In addition, the software application on the patient’s computer may enable the patient to take photographs of the attached wearable band to confirm proper placement for the neurostimulation treatment. Relevant data transmitted from the treatment device may be used to determine patient engagement with the application. Engagement data may be evaluated from the patient’s use of provided training videos and informational articles. The data can include visual aids such as charts of the patient’s treatment sessions or calendars of treatment sessions. Behavioral interventions adopted by the patient, such as reduced fluid consumption prior to sleep, may also be included in the patient data entered into the software application. This data can then be summarized in a report that can be reviewed by the patient or medical professional, for example to construct or modify a treatment plan. Additionally, adjustments to stimulation parameters can be made as needed to optimize therapy outcomes and ensure patient comfort.

[0108] Use of the treatment device can provide biological feedback to the patient to retrain the patient’s bladder for appropriate urination by a combination of nerve retraining with biofeedback therapy. Behavioral therapy may also be usedincluding bladder training and dietary or other modifications. Bladder training may involve scheduled voiding and gradual increases in the time between urination to improve bladder control and reduce urinary urgency. The device may be used for neurostimulation to reduce urgency sensation during the urine holding intervals during training. This can provide nerve retraining and help promote normalization of signals between the bladder and the brain to reduce frequency of an urgency. Neurostimulation can also be applied to peripheral nerves, such as pudendal, sacral, saphenous, splanchnic, sural to modulate sensory reintegration potentiating the learning response by providing indirect stimulation of nerves in the sacral plexus, modulating afferent signals from the bladder to the brain, and providing a tool for biofeedback training. Methods of retraining nerves for desired behavior using electrical stimulation are known in the art. Through a comprehensive approach combining behavior therapy for OAB with neurostimulation for nerve retraining, the device and methods of the present disclosure can provide a holistic treatment solution for individuals experiencing bladder dysfunction and neurological impairments, promoting improved bladder control, enhanced motor function and overall quality of life.

[0109] It will be appreciated that any one or more implementations of the incontinence treatment device and methods disclosed herein may be used in conjunction with any one or more of the other implementations of the present disclosure.

[0110] The foregoing description has been presented for the purpose of illustration and is not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed. Persons skilled in the relevant art can appreciate that many modifications and variations are possible in light of the above disclosure.

[0111] The language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the present disclosure be limited not by this detailed description, but rather by any claims that issue on an application based hereon. Accordingly, the disclosure of the implementations of the present disclosure is intended to be illustrative, but not limiting, of the scope of the present disclosure, which is set forth in the following claims.

[0112] While the invention has been described with reference to someimplementations, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from essential scope thereof. Therefore, it is intended that the invention not be limited to the particular implementations disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all implementations falling within the scope of the claims.

Claims

We Claim:

1. A neurostimulation treatment device comprising: a) a wearable band having an upper surface and a lower surface, wherein the lower surface contacts the epidermis of a patient’s ankle proximate to a posterior tibial nerve, b) a housing on the upper surface of the wearable band, the housing configured to enclose a stimulating microneedle electrode array for percutaneously piercing the epidermis on the patient’s lower leg, and configured to extend the microneedle electrode array to move from a retracted position in the housing to an extended position from the housing to pierce the patient’s epidermis to apply neurostimulation to the posterior tibial nerve; c) a second electrode located separately from the microneedle electrode array; and d) a control unit releasably attachable to the upper surface of the wearable band that is operative to deliver an electric current or pulse to the stimulating microneedle electrode array.

2. The neurostimulation treatment device of Claim 1, further comprising a positioning template releasably attachable to the upper surface of the wearable band, the positioning template having a first aperture and a second aperture, where the first aperture is sized and shaped to be positioned at a patient’s lateral or medial malleolus to position the first stimulating microneedle electrode array proximate to the posterior tibial nerve, wherein the second aperture is sized and shaped to receive the housing containing the microneedle electrode array.

3. The neurostimulation treatment device of claim 2, wherein the second electrode is a gel electrode.

4. The neurostimulation treatment device of Claim 1, further comprising at least one additional microneedle electrode array for stimulating the tibial nerve at anadditional location on the wearable band and in electrical communication with the control unit.

5. The neurostimulation treatment device of Claim 1, wherein the microneedle electrode array and the second electrode are supplied with biphasic electrical current during treatment of a patient.

6. The neurostimulation treatment device of claim 1 , wherein the control unit includes at least one sensor to detect position or movement of a patient while wearing the device.

7. The neurostimulation treatment device of claim 1 , wherein the control unit includes any one or more of a gyroscope, an accelerometer, thermometer, an impedance sensor, voltmeter and inertial monitoring unit.

8. The neurostimulation treatment device of claim 1, wherein the control unit comprises a processor, a memory and a recorder to record and transmit data from the neurostimulation device to a remote receiving device that records and evaluates the data received from the control unit.

9. The neurostimulation device of claim 9, wherein the data received by the remote receiving device is utilized to monitor patient compliance with a treatment plan established by a medical professional for the patient’s use of the device for treatment.

10. The neurostimulation device of claim 1, wherein the control unit includes atleast one component that is operative to receive transmitted data from a remote transmitting device, wherein the transmitted data adjusts at least one parameter of the neurostimulation of the posterior tibial nerve by the microneedle electrode array.

11. The neurostimulation treatment device of claim 10, wherein the at least one parameter is selected from the group consisting of duration of stimulation, waveform of the electrical current, frequency of application of the electrical current, intensity of stimulation, and a combination thereof.

12. The neurostimulation device of claim 11 , wherein the control unit is programmed to deliver stimulation at pre-determined times.

13. The neurostimulation treatment device of claim 1, wherein the lower surface of the wearable band incorporates an adhesive.

14. The neurostimulation treatment device of claim 1, wherein the wearable band is configured as a cuff, a strip or a patch that does not fully enclose the lower leg or ankle of the patient.

15. The neurostimulation treatment device of claim 1, wherein the housing is configured to have a depressible surface in contact with the upper surface of the microneedle electrode array to extend the microneedles of the microneedle electrode array out of the housing to pierce the epidermis of the patient’s ankle when pressure is applied to the depressible surface.

16. The neurostimulation treatment device of Claim 15, wherein the depressible surface of the housing is in contact with the top of a spring that has a bottom in contact with the upper surface of the microneedle electrode that is compressed when the depressible surface is contacted, extending the microneedles of the microneedle electrode array out ofthe housing to pierce the epidermis of the patient’s ankle when pressure is applied to the depressible surface.

17. The neurostimulation treatment device of Claim 15, wherein an applicator is used to depress the depressible surface extending the microneedles of the array to pierce the epidermis of the patient’s ankle when pressure is applied to the depressible surface.

18. A method of treating a condition mediated by the tibial nerve of a patient, the method comprising: a) applying the neurostimulation treatment device of claim 1 or 2 to a patient’s lower leg and ankle proximate to the posterior tibial nerve; b) initiating a neurostimulation treatment session by extending the microneedle electrode array to pierce the epidermis proximate to the tibial nerve; and c) providing neurostimulation to the tibial nerve for a sufficient time to inhibit urgency.

19. The method of claim 17, wherein the patient applies the neurostimulation device to their lower leg and ankle proximate to the posterior tibial nerve and initiates a neurostimulation treatment session to suppress or delay urination when they perceive the need to urinate.

20. The method of claim 17, wherein the control unit has been programmed to initiate treatment at one or more specified times.

21. The method of claim 17, wherein data from a treatment session is received by the control unit of the neurostimulation treatment device and is transmitted to a remote receiver.

22. The method of claim 20, wherein the data that is transmitted to a remote receiver is reviewed by a remote medical professional.

23. The method of claim 17, further comprising providing the patient with an interactive software application for use on a computer that allows the patient to receive instructions for applying and operating the neurostimulation treatment device.

24. A method treating a condition mediated by the tibial nerve of a patient, the method comprising: a) applying to a patient’s lower leg and ankle a neurostimulation treatment device for stimulating the posterior tibial nerve, comprising a wearable band having an upper surface and a lower surface, wherein the lower surface contacts the epidermis of a patient’s ankle proximate to a posterior tibial nerve, and having a housing on the upper surface of the wearable band, the housing configured to enclose a stimulating microneedle electrode array for percutaneously piercing the epidermis on the patient’s lower leg, and configured to extend the microneedle electrode array to move from a retracted position in the housing to an extended position from the housing to pierce the patient’s epidermis to apply neurostimulation to the posterior tibial nerve, and having a second electrode located separately from the microneedle electrode array, and having and a control unit releasably attachable to the upper surface of the wearable band that is operative to deliver an electric current or pulse to the stimulating microneedle electrode array; b) initiating a neurostimulation treatment session by extending the microneedle electrode array to pierce the epidermis proximate to the tibial nerve; and c) providing neurostimulation to the tibial nerve for a sufficient time to inhibit urination.

25. The method of claim 24, wherein the neurostimulation treatment device is positioned on the patient’s lower leg and ankle with a positioning template comprising an aperture shaped and sized to receive the patient’s ankle bone and an aperture to allow the top of the housing to extend above the wearable band’s upper surface to locate the microneedle electrode array proximal to the patient’s posterior tibial nerve for neurostimulation.

26. A method of treating nocturia comprising: a) applying to a patient’s lower leg and ankle a neurostimulation treatment device for stimulating the posterior tibial nerve, comprising a wearable band having an upper surface and a lower surface, wherein the lower surface contacts the epidermis of a patient’s ankle proximate to a posterior tibial nerve, and the treatment device having a housing on the upper surface of the wearable band, the housing configured to enclose a stimulating microneedle electrode array for percutaneously piercing the epidermis on the patient’s lower leg, the housing configured to extend the microneedle electrode array to move from a retracted position in the housing to an extended position from the housing to pierce the patient’s epidermis to apply neurostimulation to the posterior tibial nerve, the treatment device having a second electrode located separately from the microneedle electrode array, and having a control unit releasably attachable to the upper surface of the wearable band that is operative to deliver an electric current or pulse to the stimulating microneedle electrode array; b) Sensing, recording, reporting and analyzing the patient’s movement and episodes of urination during sleep to predict when episodes of nocturia occur; and c) Structuring a neurostimulation treatment plan for the patient’s use of the neurostimulation treatment device during sleep based on the results of analysis in step b) in which the device initiates a treatment session at the predicted times of nocturia.

27. A patient kit for treating incontinence, comprising: a) at least one wearable band having an upper surface and a lower surface, where the lower surface contacts the epidermis of a patient’s lower leg and ankle proximate to a posterior tibial nerve, the at least one wearable band having a housing on the upper surface of the wearable band, the housing configured to comprise at least one microneedle electrode array for percutaneously piercing the epidermis on the ankle of the patient’s foot to apply neurostimulation to the posterior tibial nerve, and having a control unit for providing electrical current to the microneedle electrode array; b) a second electrode located separately from the microneedle electrode array on the at least one wearable band; andc) at least one positioning template releasably attachable to the upper surface of the wearable band, the positioning template having a first aperture and a second aperture; where the first aperture is sized and shaped to be positioned at a patient’s lateral or medial malleolus to position the first stimulating microneedle electrode array proximate to the posterior tibial nerve, wherein the second aperture is sized and shaped to receive the housing containing the control unit on the wearable band.

28. The patient kit of claim 27, further comprising an applicator for extending the at least one microneedle electrode array and instructions for applying and using the device.

29. The patient kit of claim 26, comprising a wearable band with a housing, control unit, and a releasably attachable template for placement on the lower left leg and ankle of the patient’ s foot and a wearable band with a housing, control unit and a releasably attachable template for placement on the lower right leg and ankle of the patient’s foot.

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