System, method, and wearable device for noninvasive treatment of urinary urgency

Abstract

A method and system for noninvasive treatment of urinary urgency in a subject may include a transcutaneous wearable stimulator device for everywhere use. The device may include a first electrode, shaped as an acupressure ball, adapted to be attached to the skin at an optimal acupressure location, and a second electrode, adapted to be attached to the skin at a medial longitudinal arch of the subject's foot. The device may include a location module, adapted to find the optimal acupressure location of the first electrode over the subject's tibial nerve, and a signal generator adapted to conduct an electric current between the electrodes, according to a predetermined pattern.

Description

SYSTEM, METHOD, AND WEARABLE DEVICE FOR NONINVASIVETREATMENT OF URINARY URGENCYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority of IL Patent Application No. 309423, filed December 14, 2023, the contents of which are incorporated herein by reference in their entirety.FIELD OF THE INVENTION

[0002] The present invention relates generally to medical devices. More specifically, the present invention relates to a device and a method of noninvasive treatment of urinary urgency.BACKGROUND OF THE INVENTION

[0003] Urinary urgency is a common symptom experienced by individuals with overactive bladder (OAB). OAB is a condition characterized by a sudden and uncontrollable urge to urinate, often leading to frequent urination and involuntary leakage of urine (referred to as urgency incontinence).

[0004] Traditional treatment approaches for OAB include lifestyle modifications, behavioral therapies, medications, and invasive procedures such as sacral neuromodulation or botulinum toxin injections. However, these options may not be suitable for all patients and may carry certain risks, side effects and significant invasiveness of treatment.

[0005] Current non-invasive treatment for symptoms of urinary urgency and overactive bladder (OAB) may include transcutaneous tibial nerve stimulation (TTNS). Such methods stimulate the peripheral tibial nerve, located near the ankle, using electrical impulses delivered through the skin.

[0006] Existing devices limit patient mobility and are therefore only used as therapy at home or in a medical office. Therefore, there is an unmet need for effective devices for daily, continuous, and everywhere use.SUMMARY OF SOME EMBODIMENTS

[0007] Embodiments of the invention may facilitate convenient everywhere use and instead of inconvenient medicine treatment and any kinds of intervention, allows therapy to be carried out at home / anywhere to improve bladder function and reduces the frequency ofurinary incontinence episodes and strives to suppress the urge to urinate by activating on demand transcutaneous tibial neuromodulation.

[0008] Embodiments of the invention may include a device for noninvasive treatment of urinary urgency in a subject. According to some embodiments, the device may include at least one first transcutaneous electrode; a fastener, configured to non-invasively press the first electrode against a first location in a foot of the subject; at least one second transcutaneous electrode, configured to be non-invasively attached to a second location on the foot; and a signal generator. The signal generator may be configured to produce electrical current between the first and second locations, via the first and second electrodes.

[0009] According to some embodiments, the first location may be defined within a region of a posterior side of the subject’s ankle, and the second location may be defined within a region of a medial longitudinal arch of the subject’s foot.

[0010] According to some embodiments, the fastener may be adapted to position the first electrode against the subject’s foot at the first location, so as to apply clinically effective acupressure on the subject’s tibial nerve.

[0011] According to some embodiments, the device may include, or may be associated with at least one controller or processor. The controller may be configured to receive a treatment setting data element, which corresponds to a required work mode of the device, and configure the signal generator to produce the electrical current based on, or according to the treatment setting data element.According to some embodiments, the work mode may include, for example, a treatment mode, characterized by a first pattern of pulses of the electrical current. The first pattern of pulses may be adapted to treat a chronic state of urinary bladder incontinence. Additionally, or alternatively, the work mode may include an urgency mode, characterized by a second, different pattern of pulses of the electrical current. The second pattern of pulses may be adapted to treat an immediate condition of urination urgency.

[0012] According to some embodiments, the device may further include a probing unit, configured to measure impedance or conductance between the first and second electrodes, and an indicator unit, configured to indicate an optimal location for positioning the first electrode.

[0013] In such embodiments, the controller may be configured to receive from the probing unit a plurality of impedance readings or measurements that correspond to different,respective locations of the at least one first electrode within the posterior side of the subj ecf s ankle. The controller may identify an impedance reading having a minimal value among the plurality of impedance readings, and subsequently indicate, or control the indicator unit to indicate a location corresponding to the identified minimal value impedance reading. The indicated location will typically be located over the subject’s tibial nerve, and may therefore be referred to as an optimal location for positioning the at least one first electrode.

[0014] According to some embodiments, the treatment device may be integrated, or included in a system for treatment of urinary urgency.

[0015] Embodiments of the system may, for example, further include a bladder sensor, adapted to measure a volume of the subject’s urine bladder. In such embodiments, the controller may be configured to receive an indication of the bladder volume from the bladder sensor; and configure the signal generator to produce the electrical current further based on the bladder volume indication.

[0016] For example, the controller may be configured to calculate a Post Voiding Residual (PVR) urine volume of the subject based on the bladder volume indication; and configure the signal generator to produce the electrical current further based on the calculated PVR volume.

[0017] Additionally, or alternatively, embodiments of the system may include at least one client computing device. In such embodiments, the controller may be configured to transmit, to the at least one client computing device, one or more subject data elements representative of the subject. The at least one client computing device may, in turn, be configured to produce a treatment setting data element that is personalized for the subject based on the subject data elements, and transmit the personalized settings data element to the controller in response to said communication.

[0018] Additionally, or alternatively, Embodiments of the system may further include at least one server, in communication with the at least one client computing device. In such embodiments, one or more (e.g., each) client computing device may be associated with a treatment account of a specific subject. In such embodiments, the server computing device may be configured to maintain the treatment account of the at least one client computing device; and enable the at least one client computing device to produce the treatment setting data element based on treatment account of the corresponding subject.

[0019] Embodiments of the invention may include a method of noninvasive treatment of urinary urgency in a subject. Embodiments of the method may include providing a first transcutaneous electrode; providing a fastener, adapted to position the first electrode against the subject’s foot at a first location, so as to apply clinically effective acupressure on the subject’s tibial nerve; and providing a second transcutaneous electrode, configured to be non-invasively attached to a second location on the foot. Embodiments of the method may further include receiving, by at least one controller, a treatment setting data element corresponding to a required work mode of a signal generator; and configuring the signal generator by the at least one controller, based on the treatment setting data element, to produce electrical current between the first and second locations via the first and second electrodes.

[0020] Embodiments of the invention may include system for noninvasive treatment of urinary urgency in a subject. Embodiments of the system may include a first transcutaneous electrode; a fastener, configured to non-invasively press the first electrode against a first location in a foot of the subject; a second transcutaneous electrode, configured to be non- invasively attached to a second location on the foot; and a signal generator. Embodiments of the system may further include a transitory and / or a non-transitory memory and / or memory device, wherein modules of instruction code are stored; and at least one controller associated with the memory device, and configured to execute the modules of instruction code. Upon execution of said modules of instruction code, the at least one controller may be configured to control the signal generator, to produce electrical current between the first and second locations, via the first and second electrodes.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which:

[0022] Fig. 1 is a block diagram, depicting a computing device which may be included in a system for noninvasive treatment of urinary urgency according to some embodiments;

[0023] Fig. 2 is a schematic diagram of a foot, showing an example for application of a device for treating urinary urgency in a subject, according to some embodiments of the invention;

[0024] Fig. 3 is a block diagram, depicting a device, and system for treatment of urinary urgency according to some embodiments of the invention; and

[0025] Fig. 4 is a flow diagram, depicting a method of treating urinary urgency according to some embodiments of the invention.

[0026] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0027] One skilled in the art will realize the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting of the invention described herein. Scope of the invention is thus indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

[0028] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention. Some features or elements described with respect to one embodiment may be combined with features or elements described with respect to other embodiments. For the sake of clarity, discussion of same or similar features or elements may not be repeated.

[0029] Although embodiments of the invention are not limited in this regard, discussions utilizing terms such as, for example, “processing,” “computing,” “calculating,” “determining,” “establishing”, “analyzing”, “checking”, or the like, may refer to operation(s) and / or process(es) of a computer, a computing platform, a computing system, or otherelectronic computing device, that manipulates and / or transforms data represented as physical (e.g., electronic) quantities within the computer’s registers and / or memories into other data similarly represented as physical quantities within the computer’s registers and / or memories or other information non-transitory storage medium that may store instructions to perform operations and / or processes.

[0030] Although embodiments of the invention are not limited in this regard, the terms “plurality” and “a plurality” as used herein may include, for example, “multiple” or “two or more”. The terms “plurality” or “a plurality” may be used throughout the specification to describe two or more components, devices, elements, units, parameters, or the like. The term “set” when used herein may include one or more items.

[0031] Unless explicitly stated, the method embodiments described herein are not constrained to a particular order or sequence. Additionally, some of the described method embodiments or elements thereof can occur or be performed simultaneously, at the same point in time, or concurrently.

[0032] Reference is now made to Fig. 1, which is a block diagram depicting a computing device, which may be included within an embodiment of a system for treating urinary urgency, according to some embodiments.

[0033] Computing device 1 may include a processor or controller 2 that may be, for example, a central processing unit (CPU) processor, a chip or any suitable computing or computational device, an operating system 3, a memory 4, executable code 5, a storage system 6, input devices 7 and output devices 8. Processor 2 (or one or more controllers or processors, possibly across multiple units or devices) may be configured to carry out methods described herein, and / or to execute or act as the various modules, units, etc. More than one computing device 1 may be included in, and one or more computing devices 1 may act as the components of, a system according to embodiments of the invention.

[0034] Operating system 3 may be or may include any code segment (e.g., one similar to executable code 5 described herein) designed and / or configured to perform tasks involving coordination, scheduling, arbitration, supervising, controlling or otherwise managing operation of computing device 1, for example, scheduling execution of software programs or tasks or enabling software programs or other modules or units to communicate. Operating system 3 may be a commercial operating system. It will be noted that an operating system 3may be an optional component, e.g., in some embodiments, a system may include a computing device that does not require or include an operating system 3.

[0035] Memory 4 may be or may include, for example, a Random- Access Memory (RAM), a read only memory (ROM), a Dynamic RAM (DRAM), a Synchronous DRAM (SDRAM), a double data rate (DDR) memory chip, a Flash memory, a volatile memory, a nonvolatile memory, a cache memory, a buffer, a short term memory unit, a long term memory unit, or other suitable memory units or storage units. Memory 4 may be or may include a plurality of possibly different memory units. Memory 4 may be a computer or processor non-transitory readable medium, or a computer non-transitory storage medium, e.g., a RAM. In one embodiment, a transitory storage medium, or a non-transitory storage medium such as memory 4 (e.g., a hard disk drive, another storage device, etc.) may store instructions or code which when executed by a processor may cause the processor to carry out methods as described herein.

[0036] Executable code 5 may be any executable code, e.g., an application, a program, a process, task, or script. Processor or controller 2 may execute executable code 5 possibly under control of operating system 3. For example, executable code 5 may be an application that may treat urinary urgency as further described herein. Although, for the sake of clarity, a single item of executable code 5 is shown in Fig. 1, a system according to some embodiments of the invention may include a plurality of executable code segments similar to executable code 5 that may be loaded into memory 4 and cause processor 2 to carry out methods described herein.

[0037] Storage system 6 may be or may include, for example, a flash memory as known in the art, a memory that is internal to, or embedded in, a micro controller or chip as known in the art, a hard disk drive, a CD-Recordable (CD-R) drive, a Blu-ray disk (BD), a universal serial bus (USB) device or other suitable removable and / or fixed storage unit. Data pertaining to treatment of urinary urgency may be stored in storage system 6 and may be loaded from storage system 6 into memory 4 where it may be processed by processor or controller 2. In some embodiments, some of the components shown in Fig. 1 may be omitted. For example, memory 4 may be a non-volatile memory having the storage capacity of storage system 6. Accordingly, although shown as a separate component, storage system 6 may be embedded or included in memory 4.

[0038] Input devices 7 may be or may include any suitable input devices, components, or systems, e.g., a detachable keyboard or keypad, a mouse and the like. Output devices 8 may include one or more (possibly detachable) displays or monitors, speakers and / or any other suitable output devices. Any applicable input / output (I / O) devices may be connected to Computing device 1 as shown by blocks 7 and 8. For example, a wired or wireless network interface card (NIC), a universal serial bus (USB) device or external hard drive may be included in input devices 7 and / or output devices 8. It will be recognized that any suitable number of input devices 7 and output device 8 may be operatively connected to Computing device 1 as shown by blocks 7 and 8.

[0039] A system according to some embodiments of the invention may include components such as, but not limited to, a plurality of central processing units (CPU) or any other suitable multi-purpose or specific processors or controllers (e.g., similar to element 2), a plurality of input units, a plurality of output units, a plurality of memory units, and a plurality of storage units.

[0040] Reference is now made to Fig. 2, which is a schematic diagram of a foot, showing an example for application of a device (e.g., device 10 of Fig. 3) for treating urinary urgency in a subject, according to some embodiments of the invention.

[0041] The term “foot” may be used herein to describe a distal (e.g., lower) extremity of a person’s leg, and may include body parts distal (e.g., below), and directly proximate (e.g., above) the person’s ankle, as depicted in Fig. 2.

[0042] Reference is also made to Fig. 3, which is a block diagram depicting a device 10, and a system 100 for treating urinary urgency according to some embodiments of the invention. According to some embodiments of the invention, system 100 may include one more devices 10, and may be implemented as a combination of software and / or hardware modules.

[0043] For example, system 100 may include at least one computing device such as element 1 of Fig. 1, and may be adapted to execute one or more modules of executable code (e.g., element 5 of Fig. 1) to treat urinary urgency, as further described herein.

[0044] As shown in Fig. 3, arrows may represent flow of one or more data elements to and from system 100 and / or among modules or elements of system 100. Some arrows may have been omitted in Fig. 3 for the purpose of clarity.

[0045] As shown in Fig. 3, device 10 for treating urinary urgency may include an application unit 20. As shown in Fig. 2, application unit 20 may include a first transcutaneous electrode 20E1, a corresponding first fastener or attachment Fl, a second transcutaneous electrode 20E2, and a corresponding second fastener or attachment F2.

[0046] Fastener Fl may, for example, be implemented as an anklet, configured to non- invasively press the first electrode against a first location LI on a foot of the subject.

[0047] As shown in Fig. 2, the first location LI may be defined within a region of a posterior side of the subject’s ankle, such that electrode 20E1 may be pressed against the subject’s skin, over the subject’s tibial nerve in that anatomic region.

[0048] According to some embodiments, electrode 20E1 may have a rounded shape, or tip, to avoid penetrating a subject’s skin in response to applied pressure, but rather serve as a conduit for applying acupressure thereon. Accordingly, fastener Fl may be adapted to position the first electrode 20E1 against the subject’s foot at the first location LI, so as to apply clinically effective acupressure on the subject’s tibial nerve in the first location LI. For example, electrode 20E1 may have a hemispheric shape, and may be configured to rise above a surface of the adhesive patch, to apply the mild, localized, continuous and comfortable pressure at location LI, e.g., as known in the art of acupressure treatment.

[0049] It may be appreciated by a person skilled in the art that a “clinical efficacy” of the acupressure may be determined objectively, e.g., by measuring an effect of acupressure on objective urination metric, such as timing of urination.

[0050] Additionally, or alternatively, a “clinical efficacy” of the acupressure may be determined subjectively, e.g., based on questionnaires which may inquire a subject’s urge to urinate with, and without the applied acupressure.

[0051] Embodiments of the invention may thereby combine electrical stimulation with mechanical acupressure. While activation of electrical stimulation via electrodes 20E may be time-limited or periodic, the applied acupressure may be continuous as long as applicative unit 20 is attached to the subject’s body, allowing improved clinical results in relation to currently available systems that may only rely on application of electrical stimulation.

[0052] Additionally, or alternatively, fastener Fl may be, or may include an expandable element (e.g., a balloon) for selectively applying a desired pressure, at desired timing.

[0053] Embodiments of the invention may therefore provide a several benefits over currently available systems for treating urination urgency, which typically employ needle electrodes or surgically implanted electrodes.

[0054] For example, and as elaborated herein, embodiments of the invention may include a location unit 310, that may assist in detecting an optimal position for electrodes 20E1 and 20E2. The inventors have observed that by doing so, treatment by non-invasive electrodes 20E1 and 20E2 of the present invention may be just as effective as the (e.g., invasive) electrodes of currently available systems for treating urination urgency, while avoiding the inconvenience and pain involved in using such electrodes. For example, the inventors have found that treatment by non-invasive electrodes 20E1 and 20E2 of the present invention may be just as effective as the Percutaneous Tibial Nerve Stimulation (PTNS), where invasive subcutaneous needles are inserted into a subject’s foot, to achieve proximity to the tibial nerve.

[0055] In another example, by employing ball-shaped, hemispheric or round-tipped electrodes 20E1 and / or 20E2, embodiments of the invention may apply the clinically effective acupressure. It may be appreciated that such acupressure may not be applied by invasive electrodes of currently available systems.

[0056] As shown in Fig. 2, fastener F2 may be, for example, implemented as a sticky patch, configured to attach electrode 20E2 non-invasively to a second location E2 on the foot. The second location E2 may be defined within a region of a medial longitudinal arch of the subject’s foot, such that electrode 20E2 may be attached to the subject’s skin over the subject’s tibial nerve in that anatomic region.

[0057] As elaborated herein, device 10 may include a control unit 30 that may be connected, via wired or wireless connection, to applicative unit 20. Control unit 30 may include a signal generator 320 module, configured to produce electrical current 320C between the first and second locations (El, L2), via the first and second electrodes (20E1, 20E2).

[0058] Additionally, or alternatively, signal generator 320 module may be included in application unit 20, to allow portability of device 10. In such embodiments, signal generator 320 may be communicatively connected via wired or wireless connection to control unit 30, and control unit 30 may control signal generator 320 to produce electrical current between the first and second locations (LI, L2), via the first and second electrodes (20E1, 20E2), as elaborated herein.

[0059] As shown in Fig. 3, device 10 may include a controller 330 such as controller 2 of Fig. 1.

[0060] According to some embodiments, controller 330 may calculate, or receive e.g., from a storage system 6 of Fig. 1, a treatment setting data element 330TS (also referred to herein as a “treatment profile”), corresponding to a required work mode of the device.

[0061] For example, device 10 may apply the same profile 33OTS that was used in a previous treatment session. Additionally, or alternatively, device 10 may increase the duration of the treatment or current level compared to the previous treatment by a certain amount.

[0062] Treatment setting data element 330TS may be, or may include a data structure, such as a multidimensional table that may associate between work modes, patient characteristics, and a pattern, or properties of the electrical current 320C treatment protocol between the first and second electrodes (20E1, 20E2).

[0063] The patient characteristics may include, for example, age of the patient, their gender, elements of their medical history, their weight, and the like.

[0064] The work modes may include, for example (i) a (chronic) treatment mode, characterized by a first pattern of pulses of the electrical current 320C adapted to treat a chronic state of urinary bladder incontinence, and (ii) an urgency mode, characterized by a second pattern of pulses of the electrical current 320C, adapted to treat, or alleviate an immediate condition of urination urgency, or an impending condition of urination urgency.

[0065] The pattern or profile of the electrical current 320C treatment protocol may include, for example, parameters of amperage, modulation (Pulse Width Modulation (PWM), Alternating Current (AC) modulation, and the like), treatment duration, etc.

[0066] For example, a treatment setting data element 330TS for “chronic mode” may include a waveform type (e.g., square-wave waveform) a modulation type (e.g., PWM), a period time (e.g., T_period=12.5 ms) an active time or percentage (e.g., T_active=300 usee), a maximal current amplitude (e.g., 1=200 mA, set according to the patient’s comfort), a duration of treatment (e.g., T_duration = 30 min), and the like. T_active and T_period may vary during the treatment, for example every Isec.

[0067] In another example, a treatment setting data element 330TS for “urgency mode” may include a waveform type (e.g., square-wave waveform) a modulation type (e.g., PWM), T_active = 300 usee, T_period = 6 ms, a maximal current amplitude (e.g., 1=200 mA, setaccording to the patient’s comfort), a duration of treatment (e.g., T_duration = 5 min). T_active and T_period may vary during the treatment, for example every Isec.

[0068] It may be appreciated that embodiments of the invention may activate urgency mode treatment in places where urinary incontinence is possible, for example, near the door of an apartment, e.g., when a person approaches their house, even before he enters the door key. Urgency mode can be activated to prevent urinary incontinence.

[0069] As shown in Fig. 3, system 100 may include, or may be communicatively connected to a client computing device 50 such a smartphone associated with the treated patient. In such embodiments, device 10 may obtain treatment setting data element 330TS via a user interface or input (e.g., input 7 of Fig. 1) of client computing device 50.

[0070] Additionally, or alternatively, system 100 may include, or may be communicatively connected (e.g., via client computing device 50) to a telemedicine server computing 40. In such embodiments, device 10 may obtain treatment setting data element 330TS from telemedicine server computing 40.

[0071] Controller 30 may subsequently control, or configure signal generator 320 to produce electrical current 320C based on the treatment setting data element 330TS, thereby applying current 320C between locations LI and L2 of the patient’s foot.

[0072] It has been clinically observed that stimulation of the Tibial nerve may be utilized to treat urinary urgency. However, in order to provide such efficient treatment, one must place treatment electrodes along the path of the Tibial nerve in the patient’s foot. However, finding the correct location for placing the treatment electrodes has proven to be a difficult task, often performed poorly by inexperienced operators.

[0073] According to some embodiments, device 10 may include a location unit 310, adapted to assist an operator of system 100 to find an optimal location for placing the first and second electrodes (20E1, 20E2).

[0074] It may be appreciated that electrical conductance via the nervous system is superior to that of other bodily tissues including skin, muscle and bone. Location unit 310 may exploit this observation, to identify an impedance reading having a minimal value, or one that is in a range of values beneath a predetermined threshold among a plurality of impedance readings, under the assumption that such a reading would correspond to the path of the patient’s Tibial nerve.

[0075] As shown in Fig. 3, location unit 310 may include a probing unit 312 and an indicator unit 315. Probing unit 312 may be configured to measure an electrical value, such as electrical impedance, voltage, and / or current, between the first and second electrodes (20E1, 20E2). Indicator unit 315 may obtain electrical values from multiple readings or locations of electrodes (20E1, 20E2), and may in turn provide indication or signal marking an optimal location for positioning at least one of the electrodes (e.g., 20E1).

[0076] For example, controller 330 may receive, from probing unit 312 a plurality of impedance readings, each corresponding to different locations of the first electrode 20E1 within a region of the posterior side of the subject’s ankle. Controller 330 may then control indicator unit 315, to produce an indication 315IND of a location that corresponds to the identified minimal value impedance reading. The indicated location may be referred to as an optimal location for positioning first electrode 20E1. Indication 315IND may include, for example, an audible indication such as a beep, a visual indication such as a flashing light, a textual or numerical indication, and the like. In some embodiments, the location indicated by indication 315IND may refer to a Region-of-Interest (ROI) of the size of a few square mm or cm.

[0077] Additionally, or alternatively, probe module 312 may include a transmitting unit 312T, adapted to transmit an electric signal 312TS to a first electrode (e.g., 20E1) in a first (e.g., LI) location on the foot.

[0078] In some embodiments of the invention, transmitting unit 312T may be implemented as a separate module from signal generator module 320, as depicted in Fig. 3. Additionally, or alternatively, transmitting unit 312T may be implemented as part of signal generator module 320.

[0079] Probe module 312 may also include a reception unit 312R, adapted to receive an electric signal 312RS, induced by transmitted electric signal 312TS, from a second electrode (e.g., 20E2) in a second (e.g., LI) location on the foot. Probe module 312 may provide a sampled, digital version of the received signal 312RS to controller 330. Controller 330 may analyze received signal 312RS to identify a signal representing an optimal or desired location of the first electrode (e.g., 20E1) in relation to the second electrode (e.g., 20E2). Controller 330 may subsequently control indicator unit 315, to produce an indication 315IND of a location that corresponds to the identified optimal received signal 312RS, which corresponds to an optimal location for positioning the first electrode (e.g., 20E1).

[0080] According to some embodiments, location module 310 may utilize probe module 312 to accurately determine the acupuncture or acupressure point LI near the tibial nerve, using a combination of measurements, including skin conductivity and resistance / impedance. Location module 310 may thereby precisely identify points on the skin's surface that have different electrical characteristics compared to surrounding areas.

[0081] The term “skin conductivity” may be used herein to refer to the skin's ability to conduct electrical current. Inventors have experimentally shown that acupuncture points have different electrical conductivity compared to the surrounding skin. A patient may therefore pass electrode 20E1 / 20E2 over their skin, to measure changes in skin conductivity. An acupuncture point may be characterized by having lower electrical resistance in relation to its surroundings, thereby allowing more current to flow through. This difference in flow may be detected by probe 312 to indicate optimal location LI.

[0082] The terms “skin resistance” and “skin impedance” may be used herein to represent the opposite of skin conductivity. Inventors have experimentally found that acupuncture or acupressure points may be characterized as having lower resistance than the surrounding skin. Location module 310 may thereby utilize probe 312 to measure resistance to electrical current as electrode 20E1 / 20E2 it moved across the subject’s skin. Location module 310 may thus detect an area characterized by lower resistance, as optimal location LI, which corresponds to the acupressure or acupuncture point.

[0083] It may be appreciated that by enabling a user to find the optimal location for positioning electrode 20E1 / 20E2, embodiments of the invention may provide a benefit in home treatment over currently available systems for treating urination urgency:

[0084] Currently available systems which do not enable detection of optimal locations for accurately placing electrodes require either a redundant plurality of electrodes, or a trained professional caregiver for that task. Therefore, currently available systems may enable clinic-based treatment of chronic urinary urgency conditions, but cannot facilitate (a) a treatment setting 330TS for home and outdoor treatment, or (b) a treatment setting 330TS in urgency work mode, for alleviating an immediate or impending condition of urination urgency, as provided by embodiments of the invention.

[0085] According to some embodiments, system 100 may include a bladder sensor 60 that may be associated with a specific treatment device 10, and may be configured to measure, and / or provide an indication of a volume 60 V of the treated subject’s urine bladder.

[0086] Controller 330 may receive volume indication 60V from bladder sensor 60 and configure signal generator 320 to produce electrical current 320C further based on the bladder volume indication 60V.

[0087] For example, embodiments of the invention may enable treatment when the bladder is almost empty. In such embodiments, urgency mode treatment may be disabled when bladder volume indication 60V indicates a bladder that is full, beyond a predetermined volume threshold.

[0088] In another example, controller 330 may calculate a bladder volume indication 60V that is a Post Voiding Residual (PVR) urine volume of the subject based on the bladder volume indication. In such embodiments, controller 330 may configure signal generator 320 to produce electrical current 320C further based on the calculated PVR volume.

[0089] For example, signal generator 320 may disable electrical stimulation via electrodes 20E when a significant PVR (e.g., surpassing a predetermined threshold) is calculated.

[0090] According to some embodiments, controller 330 may transmit, to at least one client computing device 50 (e.g., a smartphone, a smartwatch, etc.), one or more subject data elements representative of the subject (e.g., a name, a serial number, etc.). Client computing device 50 may subsequently produce a treatment setting data element 330TS that is personalized for the subject based on the subject data elements, and transmit the personalized settings data element 330TS to controller 330 in response to said communication.

[0091] For example, client computing device 50 may be configured to prompt the treated patient to input indications regarding any sort of activity (e.g., eating, drinking, and the like), motility (e.g., sleeping, sitting, walking, and the like), and / or a condition of urination urgency. Client computing device 50 may then calculate at least one treatment setting 330TS that may include a personalized current treatment 320C protocol for that person, based on the activity, motility, and / or urination urgency indications. For example, for some patients the treatment can be turned off during sleep.

[0092] In another example, client computing device 50 may obtain indication 60V from device 10, and calculate at least one treatment setting 330TS that may include a personalized current treatment 320C protocol for that person, based on the activity, motility, and / or urination urgency indications, in addition to the bladder volume indication 60V.

[0093] For example, a personalized a treatment setting data element 330TS for “urgency mode” may include a waveform type (e.g., square-wave waveform) a modulation type (e.g.,PWM), T_active = 300 usee, T_period = 6 ms, a maximal current amplitude (e.g., 1=200 mA, set according to the patient’s comfort), a duration of treatment (e.g., T_duration = 5 min). T_active and T_period may vary during the treatment, for example every Isec.

[0094] As shown in Fig. 3, system 100 may include, or may be communicatively connected to a telemedicine server computing device 40. In such embodiments, one or more (e.g., each) client computing device 50 may be associated with a treatment account 40 AC of a specific subject. Telemedicine server computing device 40 may be configured to maintain the treatment account of the one or more client computing device 10. Account 40AC may include, for example, a ledger of the respective patient’s health condition, treatment setting 330TS, history of prior treatments, and the like.

[0095] In some embodiments, server 40 may be configured to communicate with at least one client computing device 50, to allow, or disallow production of treatment setting data element 330TS, based on the treatment account of the corresponding subject.

[0096] Additionally, or alternatively, server 40 may be configured to employ a Machine- Learning (ML) based model, adapted to set a personalized treatment setting 330TS based on treatment account 40 AC of specific subjects.

[0097] Reference is now made to Fig. 4, which is a flow diagram depicting a method of treating urinary urgency in a subject by at least one controller (e.g., 330 of Fig. 3) according to some embodiments of the invention.

[0098] As shown in steps S1005 and S1010, embodiments of the invention may provide at least one first transcutaneous electrode (e.g., 20E1 of Figs. 2, 3) and a fastener (e.g., Fl of Fig. 2), adapted to position the first electrode 20E1 against the subject’s foot at a first location (e.g., LI, as shown in Fig. 2). As elaborated herein (e.g., in relation to location module 310 of Fig. 3), embodiments of the invention may indicate an optimal location LI of the least one first transcutaneous electrode 20E1 over the subject’s tibial nerve. Embodiments of the invention may thereby apply clinically effective acupressure on the subject’s tibial nerve.

[0099] As shown in step S1015, embodiments of the invention may provide at least one second transcutaneous electrode (e.g., 20E2 of Figs. 2, 3), configured to be non-invasively attached to a second location (e.g., L2 of Fig. 2) on the foot.

[0100] As shown in steps S1020 and S1025, the at least one controller 330 may receive (e.g., via input device 7 of Fig. 1) a treatment setting data element 33OTS corresponding to a required work mode of a signal generator, associated with, or connected to electrodes20E1, 20E2. The at least one controller 330 may thereby configure the signal generator, based on the treatment setting data element, to produce electrical current between the first LI and second L2 locations, via the at least one first and at least one second electrodes 20E1, 20E2.

[0101] Unless explicitly stated, the method embodiments described herein are not constrained to a particular order or sequence. Furthermore, all formulas described herein are intended as examples only and other or different formulas may be used. Additionally, some of the described method embodiments or elements thereof may occur or be performed at the same point in time.

[0102] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents may occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

[0103] Various embodiments have been presented. Each of these embodiments may of course include features from other embodiments presented, and embodiments not specifically described may include various features described herein.

Claims

CLAIMS1. A device for noninvasive treatment of urinary urgency in a subject, the device comprising: at least one first transcutaneous electrode; a fastener, configured to non-invasively press the first electrode against a first location in a foot of the subject; at least one second transcutaneous electrode, configured to be non-invasively attached to a second location on the foot; and a signal generator, configured to produce electrical current between the first and second locations, via the first and second electrodes.

2. The device of claim 1, wherein the first location is defined within a region of a posterior side of the subject’s ankle, and wherein the second location is defined within a region of a medial longitudinal arch of the subject’s foot.

3. The device of claim 2, wherein the fastener is adapted to position the first electrode against the subject’s foot at the first location, so as to apply clinically effective acupressure on the subject’s tibial nerve.

4. The device according to any one of claims 2-3, further comprising a controller, configured to: receive a treatment setting data element, corresponding to a required work mode of the device; and configure the signal generator to produce the electrical current based on the treatment setting data element.

5. The device of claim 4, wherein said work mode is selected from (i) a treatment mode, characterized by a first pattern of pulses of the electrical current adapted to treat a chronic state of urinary bladder incontinence, and (ii) an urgency mode, characterized by a second pattern of pulses of the electrical current, adapted to treat an immediate condition of urination urgency.

6. The device according to any one of claims 4-5, further comprising: a probing unit, configured to measure impedance between the first and second electrodes; and an indicator unit, configured to indicate an optimal location for positioning the first electrode.

7. The device of claim 6, wherein the controller is further configured to: receive from the probing unit a plurality of impedance readings, corresponding to different locations of the first electrode within the posterior side of the subject’s ankle; identify an impedance reading having a minimal value among the plurality of impedance readings; and control the indicator unit, to indicate a location corresponding to the identified minimal value impedance reading, as an optimal location for positioning the first electrode.

8. A system comprising the device of claim 4, and further comprising a bladder sensor, adapted to measure a volume of the subject’s urine bladder, wherein the controller is further configured to: receive an indication of the bladder volume from the bladder sensor; and configure the signal generator to produce the electrical current further based on the bladder volume indication.

9. The system of claim 8, wherein the controller is configured to: calculate a Post Voiding Residual (PVR) urine volume of the subject based on the bladder volume indication; and configure the signal generator to produce the electrical current further based on the calculated PVR volume.

10. A system comprising the device of claim 4, and further comprising at least one client computing device, wherein the controller is further configured to transmit, to the at least one client computing device, one or more subject data elements representative of the subject,and wherein the at least one client computing device is configured to: produce a treatment setting data element that is personalized for the subject based on the subject data elements; and transmit the personalized settings data element to the controller in response to said communication.

11. The system of claim 10, wherein each client computing device is associated with a treatment account of a specific subject, and wherein the system further comprises at least one server, in communication with the at least one client computing device, said server configured to: maintain the treatment account of the at least one client computing device; and enable the at least one client computing device to produce the treatment setting data element based on treatment account of the corresponding subject.

12. A method of noninvasive treatment of urinary urgency in a subject by at least one controller, the method comprising: providing a first transcutaneous electrode; providing a fastener, adapted to position the first electrode against the subject’s foot at a first location, so as to apply clinically effective acupressure on the subject’s tibial nerve; providing a second transcutaneous electrode, configured to be non-invasively attached to a second location on the foot; receiving, by the at least one controller, a treatment setting data element corresponding to a required work mode of a signal generator; and configuring the signal generator by the at least one controller, based on the treatment setting data element, to produce electrical current between the first and second locations via the first and second electrodes.

13. The method of claim 12, wherein the first location is defined within a region of a posterior side of the subject’s ankle, and wherein the second location is defined within a region of a medial longitudinal arch of the subject’s foot.

14. The method of claim 13, wherein the fastener is adapted to position the first electrode against the subject’s foot at the first location, so as to apply clinically effective acupressure on the subject’s tibial nerve.

15. The method according to any one of claims 13-14, further comprising: receiving a treatment setting data element, corresponding to a required work mode of the device; and configuring the signal generator to produce the electrical current based on the treatment setting data element.

16. The method of claim 15, wherein said work mode is selected from (i) a treatment mode, characterized by a first pattern of pulses of the electrical current adapted to treat a chronic state of urinary bladder incontinence, and (ii) an urgency mode, characterized by a second pattern of pulses of the electrical current, adapted to treat an immediate condition of urination urgency.

17. The method according to any one of claims 15-16, further comprising: measuring, via a probing unit, impedance between the first and second electrodes; and indicating, via an indicator unit, an optimal location for positioning the first electrode.

18. The method of claim 17, further comprising: receiving, from the probing unit a plurality of impedance readings, corresponding to different locations of the first electrode within the posterior side of the subject’s ankle; identifying an impedance reading having a minimal value among the plurality of impedance readings; and controlling the indicator unit, to indicate a location corresponding to the identified minimal value impedance reading, as an optimal location for positioning the first electrode.

19. The method of claim 15, further comprising: providing a bladder sensor, adapted to measure a volume of the subject’s urine bladder; receiving an indication of the bladder volume from the bladder sensor; andconfiguring the signal generator to produce the electrical current further based on the bladder volume indication.

20. The method of claim 19, further comprising: calculating a Post Voiding Residual (PVR) urine volume of the subject based on the bladder volume indication; and configuring the signal generator to produce the electrical current further based on the calculated PVR volume.

21. The method of claim 15, further comprising: transmitting, to at least one client computing device, one or more subject data elements representative of the subject, wherein the at least one client computing device is configured to: produce a treatment setting data element that is personalized for the subject based on the subject data elements; and transmit the personalized settings data element to the controller in response to said communication.

22. The method of claim 21, wherein each client computing device is associated with a treatment account of a specific subject, and wherein the method further comprises providing at least one server, in communication with the at least one client computing device, wherein the server is configured to: maintain the treatment account of the at least one client computing device; and enable the at least one client computing device to produce the treatment setting data element based on treatment account of the corresponding subject.

23. A system for noninvasive treatment of urinary urgency in a subject, the system comprising: a first transcutaneous electrode; a fastener, configured to non-invasively press the first electrode against a first location in a foot of the subject;a second transcutaneous electrode, configured to be non-invasively attached to a second location on the foot; a signal generator; a memory device, wherein modules of instruction code are stored; and at least one controller associated with the memory device, and configured to execute the modules of instruction code, whereupon execution of said modules of instruction code, the at least one controller is configured to control the signal generator, to produce electrical current between the first and second locations, via the first and second electrodes.

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