Device for transcutaneous posterior tibial nerve stimulation

Abstract

The present application relates to a device that performs transcutaneous posterior tibial nerve stimulation for treating pelvic floor disorders and is specifically designed such that said stimulation occurs during ambulatory use given its ergonomic shape and by means of an elasticised, symmetrical and ambidextrous textile body activated by remote control and as required by the user.

Description

[0001]DETAILED DESCRIPTION OF THE DEVICE: Transcutaneous posterior tibial nerve stimulation device, operated on demand for the treatment of pelvic floor pathologies. Currently, it has been recorded that functional disorders of the pelvic floor encompass various pathologies, such as overactive bladder, chronic pelvic pain, vulvodynia, fecal incontinence, among others, which significantly affect the quality of life (Pelvic floor dysfunctions and their impact on the quality of life and sexual function of users of the Concepción Health Service, 2023 http: / / hdl.handle.net / 10045 / 137000) and emotional well-being, and therefore the autonomy in the vital functionality of the people who suffer from them, as they are often disabling. Specifically, in relation to overactive bladder, 16% of the population suffers from this type of ailment (Eapen RS, and Radomski SB, Review of the Epidemiology of overactive bladder. Res RepUrol.2016 Jun 6;8:71-6. doi: 10.2147 / RRU.S102441.PMID: 27350947; PMCID: PMC4902138. The concept of pelvic floor dysfunction refers to any alteration in the physiology of the organs that share the pelvic area, namely the urinary, digestive, and reproductive systems. Pelvic floor disorders constitute a significant health problem due to their organic nature, as well as their psychological and social implications. If we consider that this group of diseases includes: stress urinary incontinence, sexual dysfunction, fecal incontinence, constipation, anal pain, uterine prolapse, cystocele and rectocele, among others, the previous statement is explained (Adriano Castro, R., Santisteban Alba, S., & Delgado Peruyera, L.(2017). Pelvic floor defects and their impact on women's quality of life. Cuban Journal of General Comprehensive Medicine, 33(2). Retrieved from https: / / revmgi.sld.cu / index.php / mgi / article / view / 291 / 135).Pelvic floor dysfunctions have a negative impact on the quality of life of those who suffer from them, primarily in physical aspects, as well as their family, social, and work environments (Agua Naranjo, SA, Arévalo Reinoso, GE, thesis “Clinical forms of pelvic floor dysfunctions in middle-aged women. Riobamba, 2020-2021” Riobamba, Ecuador. 2022 National University of Chimborazo Faculty of Health Sciences, School of Medicine), due to the discomfort of managing episodes, generating shame, social isolation, difficulties at work and in daily activities, sleep problems, problems in their sex life, economic costs, and even mental health problems. Therapeutic schemes begin with hygienic-dietary measures: changes in diet and lifestyle habits; they also include botulinum toxin, pharmacological therapy, and sacral neurostimulation.For its treatment, neurostimulation is used, which can be performed using various techniques, including both direct stimulation and stimulation of peripheral nerves originating in key areas. Peripheral neurostimulation can be applied using two types of stimulation: percutaneous and transcutaneous. Both are connected to an electrical stimulator with a fixed frequency (20 Hz), adjustable pulse intensity (0 to 10 mA), low voltage, and a pulse width of 200 μs. For either peripheral neurostimulation solution, treatment programs consist of weekly 30-minute sessions for approximately 12 weeks, followed by sporadic treatment to maintain symptom improvement. (Peters et al., 2013).Percutaneous stimulation, such as that produced by patent AU2019297205, is characterized by the insertion of a needle cranially to the medial malleolus along with another electrode placed on the plantar arch of the foot. It is the most widely used method to date, despite having a higher risk of injury from needle percussion, as well as causing discomfort or pain to the patient and preventing ambulatory use. As an alternative, transcutaneous electrical nerve stimulation (TENS or TNS) has emerged as a therapy that, through the placement of surface electrodes, can reproduce the effectiveness of percutaneous stimulation with a lower risk of injury (Burton C. et al., 2012; Cooperberg MR et al., 2005; and Schreiner L. et al., 2013). Devices such as those described in patent US9757584B2 are used, but these are characterized by patient discomfort and prevent ambulatory use.In other words, TENS or TNS involves the use of electrical current generated by a unit to stimulate nerves for therapeutic purposes. These devices are usually connected to the skin via two or more electrodes and are capable of modulating the width, frequency, and intensity of the impulses. TENS is generally applied at an intensity that causes either afferent or efferent stimulation. TENS is also used as a non-invasive form of nerve stimulation to reduce both acute and chronic pain associated with pelvic floor disorders. It is important to note that an appropriate stimulation intensity is required to achieve pain relief with TENS (Rivas-Penilla, Luisa Fernanda, Rodríguez-Colorado, Esther Silvia, Gorbea-Chávez, Viridiana, Granados-Martínez, Verónica, & Ramírez-Isarraraz, Carlos. (2021). Electro-stimulation therapy for patients with chronic pelvic pain.Gynecology and Obstetrics of Mexico, 89(8), 603-610. Epub April 4, 2022. https: / / doi.org / 10.24245 / gom.v89i8.5404). It has been observed that treatment fidelity, which implies the agreement between the administration of TENS in a trial and current clinical guidelines, has shown that the most faithful trials tend to have positive results. Some studies have provided objective evidence that TENS can modulate or suppress pain signals in the brain (Gozani SN. Remote Analgesic Effects Of Conventional Transcutaneous Electrical Nerve Stimulation: A Scientific And Clinical Review With A Focus On Chronic Pain. J Pain Res. 2019 Nov 26;12:3185-3201. doi:10.2147 / JPR.S226600. PMID: 31819603; PMCID: PMC6885653).Neurostimulation of the sacral plexus, the origin of multiple nerves such as the pudendal and hypogastric nerves, which control bladder, defecation, and pelvic floor neuromuscular functions, has been widely used to improve bladder storage capacity (Casal-Beloy I., et al., Update on bladder electrostimulation and neurogenic bladder in pediatrics: a systematic review. Rev Neurol 2021;72 (09):313-322 doi: 10.33588 / rn.7209.2020237), reduce symptoms such as urgency and urge incontinence (both fecal and urinary), and manage chronic pain conditions such as interstitial cystitis or chronic non-bacterial prostatitis. An example is patent EP3924037B1 from Innocon Medical Aps, which claims a fixation device for electrical and mechanical nerve stimulation.Stimulation of the posterior tibial nerve via surface electrodes was proposed by McGuire in 1983. Then, in 1987, Stoller demonstrated that intermittent peripheral stimulation of the posterior tibial nerve inhibited involuntary detrusor contractions (IDCs) and decreased urge incontinence in monkeys. Subsequently, Amarenco used surface electrodes and observed objective changes, delaying IDCs and increasing maximum cystometric capacity during urodynamics with constant posterior tibial stimulation. Among peripheral techniques, transcutaneous posterior tibial nerve stimulation stands out for its effectiveness, ease of application, high tolerability, and minimal side effects. Transcutaneous posterior tibial nerve stimulation has proven to be an effective and safe option for the treatment of these disorders (Arroyo-Fernández et al.)., 2018; Posterior tibial nerve stimulation in the treatment of fecal incontinence: a systematic review. Spanish Journal of Digestive Diseases, 110(9), 577-588. https: / / dx.doi.org / 10.17235 / reed.2018.5007 / 2017). To date, the therapeutic regimens regularly used to treat pelvic floor pathologies consist of stimulation sessions at regular or programmed intervals of approximately 20 minutes, with a clinical response observed after several weeks of application; each session requires the cessation of activities by the user due to the need to connect cables and apply hydrogel in many cases, which discourages its application, decreasing patient adherence to the treatment.The patient may be in the following positions: supine or dorsal; prone or ventral; Sims' or lateral; Fowler's; and seated with feet on the floor, in all of which they are unable to walk. Regarding existing devices, current treatment approaches usually require these sessions to be conducted in offices or medical centers and administered by kinesiologists or other healthcare professionals. Some more modern wireless devices include, for example, the AU2019297205 by Nicky Agahari, or the USA 2020017130 by ElectroCore, Inc.They allow for self-administered use by the patient, but maintain the need for a structured and regular therapeutic approach. Recent studies such as "Transcutaneous Posterior Tibial Nerve Stimulation on Demand During Multichannel Urodynamics: A New Approach in the Management of Overactive Bladder" [Javier Muñoz Quintana, 2024] have shown that the acute application of electrical stimulation to the posterior tibial nerve is effective in controlling involuntary detrusor contractions (a characteristic feature of Overactive Bladder), resulting in a decrease in episodes of urge incontinence and relief of urinary urgency symptoms (a sudden and unpostponable urge to urinate) in patients diagnosed with Overactive Bladder Syndrome.This opens the possibility of adding an acute, clinically focused approach to transcutaneous posterior tibial nerve stimulation (TPNS) therapy alongside the classic approach. This would reduce symptoms from the start of therapy and allow for its application during times of greatest need while performing activities of daily living. Currently, there are no characterized devices that support ambulatory use for this type of application. Therefore, there is a need for a portable, easy-to-use, and comfortable transcutaneous TPNS device for ambulatory use.The solution proposed in this application is designed to allow users to activate it on demand while ambulatory, without interrupting their daily activities, in order to alleviate acute symptoms, eliminating the current problems of traditional methods by transforming the application of therapy from stationary to ambulatory. In this context, the incorporation of this proposed ambulatory device is of vital importance in the materialization of a new concept of therapeutic application of Posterior Tibial Neurostimulation for the treatment of pelvic floor pathologies (JA Muñoz, JO García, PA Gálvez et al., Transcutaneous posterior tibial nerve stimulation on demand during multichannel urodynamics: A new approach in the management of overactive bladder, Continence-2024, https: / / doi.org / 10.1016 / j.cont.2024.101314).There are heel clip-type devices such as US10478612B2 from Kimberly Clark Worldwide Inc. and Avent Inc., for monitoring and treating medical conditions. This device has a body that allows for ambulatory use; however, the configuration includes two separate pieces: one for the band that holds the electrodes and the adjustment body, which makes it difficult for the patient to use it independently, as they may make a mistake when fixing the pieces. Additionally, it has cathode and anode cables, which hinders its ambulatory application.Regarding portability and autonomy, this has been addressed by the Neurostim Technologies LLC device US20200338333A1, designed to suppress pain in connective tissue fibrous tissue. However, because this device has an adhesive fastening system, it would hinder its autonomous application by the user for the treatment of pelvic floor pathologies, since the electrode placement is important for the effectiveness of the treatment. Furthermore, the adhesive complicates its repeated use. This application is directed to a device that performs the function of transcutaneous stimulation of the posterior tibial nerve for the treatment of pelvic floor pathologies, specifically designed for this stimulation to occur during ambulatory use due to its ergonomic shape, using an elasticized, symmetrical, ambidextrous textile body activated by remote control and according to the user's requirements.The proposed device is an outpatient medical device designed to selectively administer electrical stimulation on demand or as needed. Its operation focuses on the transcutaneous application of low-intensity, low-frequency electrical stimulation to the posterior tibial nerve to treat various functional pathologies affecting structures and organs related to the pelvic floor. This device is designed so that users can initially apply transcutaneous stimulation to the posterior tibial nerve remotely and while outpatient, immediately blocking the urge to urinate and preventing urine leakage, thus allowing sufficient time to reach a restroom. Subsequently, it will be used in treatment mode for long-term effects.The advantages of the device lie in its ambulatory use and self-administration of NTP stimulation with remote control, compared to traditional methods that require the user to interrupt their daily activities for therapeutic application and the connection of cables and gels, if applicable. This device, by offering the possibility of adjusting the intensity and frequency of stimulation remotely, adapts to the individual needs of each user, providing personalized and effective treatment with a therapeutic approach to generate lasting changes or improvements, facilitating a chronic therapeutic approach, in addition to its acute application to relieve symptoms immediately according to the user's needs.The proposed solution takes into account the diversity of user anatomies: the stimulation sites are effective in both men and women, although individual factors such as the thickness of subcutaneous and muscle tissue can affect stimulus transmission due to the characteristics of the limb where the transcutaneous electrodes are placed. These electrodes will be positioned at two strategic points: one non-switchable electrode located posterosuperior to the medial malleolus of the tibia, and another electrode above the level of the calcaneus or plantar arch. Stimulation requires good contact with the target tissue, so the fixation device was designed considering movement and any disturbance that could cause loss of contact. Furthermore, the electrodes are designed for easy and comfortable removal without damaging the skin, unlike surface electrodes that use conductive gel.The design is intended for ease of use and a discreet appearance, promoting proper adherence to treatment. Compatible with all types of footwear. The device's construction and the symmetry of the electrode attachment unit allow for 180-degree rotation for use on either foot. The design of this instrument provides user comfort; its ease of use, aesthetics, and intuitive operation help facilitate adherence to treatment in its two modalities: by relieving acute symptoms, it achieves an immediate improvement in the user's quality of life, and through frequent use as a treatment, it helps reverse symptoms in the long term.The object of the ankle device claimed in the present invention is to provide transcutaneous posterior tibial nerve stimulation for the treatment of pelvic floor pathologies, and which allows such treatment to be performed on an ambulatory basis and on demand due to its ergonomic and ambidextrous design. The application of the device may include inhibiting, suppressing, downregulating, blocking, preventing, or otherwise neuromodulating the activity of the affected neuronal population. The described device is composed of three main components: a remote control unit for remote activation (A), a unit support body C consisting of the electrode attachment unit of the transcutaneous neurostimulator (B), and the transcutaneous neurostimulation unit (C). The remote control (A) is a remote activation controller unit that allows remote activation of the transcutaneous neurostimulation device, which is activated on demand by the user.The remote control unit is powered by an internal rechargeable battery and connects wirelessly to the transcutaneous neurostimulation device via radio frequency. The unit, comprising a printed circuit board and a low-power microcontroller, consists of monitoring and control nodes, communication base nodes, information sensors, activator nodes that communicate with trigger nodes, and warning signaling systems. It allows for wireless communication, including Wi-Fi, Bluetooth, and similar technologies, and may or may not be activated and / or connected via a mobile application. It also has the ability to illuminate an indicator light and / or emit a sound when required. It features a touchscreen with built-in power, program selection, and intensity adjustment functions. Additionally, it has a charging port for periodic recharging.This unit has a flush-mounted, easily identifiable safety activation button that prevents accidental activation and allows on-demand activation of the device. This controller is programmed to establish wireless communication with the second unit, the transcutaneous stimulation unit (C), upon power-up. Once wireless communication is established, a button can be pressed to remotely activate the transcutaneous stimulation unit. Therefore, this remote control unit, or remote activation controller, becomes the activating component of the transcutaneous neurostimulation unit (C). The remote control is powered by a battery encapsulated within the unit and also has a circuit board that allows monitoring of the battery's charge via an external port.Its design incorporates a fastening element for attaching to a bracelet, ring, or pin, allowing for versatile use. It can be worn attached to a bracelet on the wrist, a ring on the index finger, a pin, or a pocket watch, ensuring comfort and accessibility. The electrode attachment unit (B) is positioned on the user's ankle, contains the multiple electrodes, and supports the transcutaneous neurostimulation unit (C) in the stimulation zone of the posterior tibial nerve and plantar arch. This unit has electrodes inserted at specific points for stimulation. Its ergonomic and adjustable design allows it to adapt to various user anatomies, guaranteeing comfortable and effective use.The device rotates 180 degrees on its axis. When rotated, the electrode that stimulates the posterior tibial nerve in the right foot will stimulate the plantar arch in the left foot, and vice versa, allowing its use on either foot. The transcutaneous neurostimulation unit (C) has electrode connectors on its non-visible side, a controller to lock the pushbuttons, and a charging port on its side. Its symmetrical design allows it to be used on either foot simply by rotating it. This unit connects to the remote activation unit via radio frequency and can be configured to set the pulse type and intensity. The overall operation of the device involves a wireless connection between the remote activation control unit (A) and the transcutaneous neurostimulation unit (C).The latter, positioned on the ankle via the electrode attachment unit (B) with the attachment body, applies controlled electrical impulses through electrodes located at specific points on the foot to inhibit the sensation of urinary urgency caused by involuntary detrusor contractions. The user can activate the device remotely when they feel the urgent need to urinate, allowing them to carry out daily activities without inconvenience.The transcutaneous stimulation unit (C) is an electronic circuit board encapsulated within the body. This board contains a microcontroller with similar characteristics to the one in the remote control unit for remote activation. Its essential function is to establish wireless communication with the remote control unit for remote activation. When wirelessly connected, the transcutaneous stimulation unit can detect when the user has pressed the activation button and simultaneously begin the preselected cutaneous stimulation. This unit also includes a circuit board that allows for monitoring its charging via an external port.The unit that provides the pulses (TENS) included in this device operates by delivering a voltage, current, frequency, and waveform signal that is adjustable according to parameters already indicated in the document, but which are the same as traditional TENS devices. The user can program the desired settings. This signal is communicated to the electrodes via two button-type connection points typically used on electrodes. A proof-of-concept test of the device was performed to evaluate the effectiveness of intermittent, on-demand activation of Transcutaneous Electrical Nerve Stimulation (TENS) in patients evaluated at the urology clinic of the Coyhaique Regional Hospital who presented with symptoms consistent with a clinical diagnosis of overactive bladder.Subjects with negative urine cultures were included, while those who had previously received NMTP or had used antimuscarinics during the 2 weeks prior to the start of the study were excluded. Patients with a history of pelvic surgery, genital prolapse, radiotherapy, neurological pathology, or obstructive uropathy were not excluded. A standard diagnostic urodynamic study (UDI DI) was performed, selecting those patients who presented one or more involuntary detrusor contractions (IDC) along with urinary urgency during the filling cytometry. Patients who did not present these two conditions or whose bladder capacity was <20 ml / cm H2O were excluded. Those selected in this examination underwent a second filling cystometry immediately afterward, this time connected to a transcutaneous electrical nerve stimulation (TENS) device.Before beginning the second cystometry, two self-adhesive transcutaneous electrodes were positioned at the posterior tibial nerve stimulation point of the left foot (positive on the calcaneus or plantar arch and negative approximately 3–5 cm above the medial malleolus of the tibia). The device was configured in normal mode, with a frequency of 30 Hz and a pulse width of 200 µs. The intensity for application during the UDI-TENS was determined below the level of motor stimulation and in the absence of pain. During this second filling cystometry, posterior tibial nerve stimulation was initiated each time the patient indicated the onset of urinary urgency and stopped when the patient reported relief of this symptom. Both UDIs were performed with the patient seated. Bladder and abdominal pressures were measured using a 6 Fr double-lumen catheter and a rectal balloon catheter. The data were integrated using a Laborie Aquarius® LT device.Physiological saline solution at room temperature was used, and the infusion rate was 40-50 ml / min. No provocative maneuvers were performed, and filling was stopped upon intense urge to urinate or if terminal DIC was triggered. During the diagnostic DUI, the number of DICs, the CCM, episodes of urge urinary incontinence (UIU), and bladder accommodation were recorded for each patient. In the TENS-DUI, the number of TENS device activations was recorded along with the aforementioned parameters. Twelve subjects were selected, including 2 men and 10 women, with a mean age of 53 years (range 23-81 years), who underwent transcutaneous tibial nerve stimulation (TTNS) while a second cystometry was performed (TENS-DUI). Urodynamics of two patients are observed: a 78-year-old male patient with bladder outlet obstruction and a female patient with painful bladder syndrome (Figure 3 and Figure 4).During the DG IDU, an average of 3.33 ± 1.3 involuntary detrusor contractions (IDCs) were observed per patient, with an average duration of 33 ± 19 s, and an average of 0.67 ± 0.98 episodes of urge urinary incontinence (UUI) per patient. Meanwhile, the maximum cystometric capacity (MCC) reached 235 ± 79 ml (Table 1). In comparison, during the conditional TENS IDU, a decrease in the number of IDCs was recorded, averaging 0.08 ± 0.29 (p ≤ 0.001), and there were no UUI episodes. An increase in MCC to 315 ± 83 ml was observed (p = 0.00012). An average of 5.25 ± 2.56 active detrusor contractions (ACTs) were recorded, with an average duration of 26 ± 10 s (Table 2). After each device activation, patients reported a significant decrease in the intensity of urinary urgency. A quantitative reduction in the duration of ACTs was observed compared to the duration of IDCs (26 ± 10 vs. 26 ± 10 s).33 ± 19 s, respectively), which did not reach statistical significance (p = 0.33). Table 1. Events per patient during filling cystometry in diagnostic urodynamics. BC: bladder accommodation; MCC: maximum cystometric capacity; IDC: involuntary detrusor contraction; UUI: urge-urinary incontinence. Table 2. Events per patient during filling cytometry in TENS urodynamics BC: bladder accommodation; MCC: maximum cystometric capacity; IDC: involuntary detrusor contraction; UUI: urge-urinary incontinence; ACT: TENS activation.EXAMPLES OF IMPLEMENTATIONExample of implementation: ambulatory self-administration of transcutaneous electrostimulation of the posterior tibial nerve to relieve acute symptoms of urinary incontinenceThe user takes and places the Electrode Fixation Unit (B), which contains the transcutaneous neurostimulation Unit (C), as shown in Fig. 6B if used on their right foot, or as shown in Fig. 6C, if used on their left foot; Next, adjust the device's fixing strap (item 6). After adjusting the device as shown in Fig. 8B, Fig. 8A and Fig. 8C, you can cover your foot normally with the clothing and footwear of your choice (socks, shoes). The user will adjust the Remote Control Unit shown in Fig.5D, placing the fastening and anchoring element (element 5), to incorporate the Remote Control unit into a watch as shown in Fig. 9A, into a ring as shown in Fig. 9B or into a bracelet as shown in Fig. 9C, being able to use other elements such as a pin or keyring. The user, at the place and time of day when they suffer acute symptoms of urinary incontinence, will be able to activate the device to apply the stimulus in a static or ambulatory manner; for this they will turn on the remote control with the activator (element 3) and choose on the screen (element 1), the treatment program for acute symptoms, which will start the transcutaneous application of stimuli on the posterior tibial nerve.Example of self-administration of outpatient transcutaneous electrostimulation treatment of the posterior tibial nerve for long-term reversal of urinary incontinence symptoms. The user takes and places the Electrode Fixation Unit (B), which contains the Transcutaneous Neurostimulation Unit (C), as shown in Fig. 6B if used on their right foot, or as shown in Fig. 6C if used on their left foot; Next, adjust the device's fixing strap (item 6). After adjusting the device as shown in Fig. 8B, Fig. 8A and Fig. 8C, you can cover your foot normally with the clothing and footwear of your choice (socks, shoes). The user will adjust the Remote Control Unit shown in Fig. 5D, placing the fastening and anchoring element (item 5), to incorporate the Remote Control Unit into a watch as shown in Fig. 9A, or into a ring as shown in Fig.9B or on a bracelet as shown in Fig. 9C, and other elements such as a pin or keyring can be used. The user, at the place and time of day when they need to receive their treatment autonomously, selectively, for the long-term reversal of their pelvic floor pathology, urinary incontinence, can activate the device to apply the stimulus statically or while walking; for this they will turn on the remote control with the activator (element 3) and choose on the screen (element 1), the therapeutic treatment program, which will start the transcutaneous application of stimuli on the posterior tibial nerve.

Claims

AMENDED CLAIMS received by the International Bureau on 29 November 2025 (29.11.2025)

1. An electrical neuromodulation device for the tibial and plantar nerves in a user, comprising: an anatomical body or support of the heel cup type configured to surround the user's ankle and heel; a plurality of electrodes for transcutaneous electrical stimulation, arranged on the body or support and defining at least: a first electrode zone intended, in use, to be located over a region adjacent to the tibial nerve proximal to the medial malleolus, and a second electrode zone intended, in use, to be located over a plantar region of the user's foot in which plantar nerves originating from the tibial nerve run; a portable and rechargeable electrostimulator,configured to connect electrically to said plurality of electrodes and to generate electrical impulses for nerve stimulation; and a control module comprising at least one remote activation device configured to communicate wirelessly with the electrostimulator and to allow the user to selectively activate and deactivate the application of said electrical impulses during the performance of activities of daily living while ambulatory, in response to the perception of episodes of urinary urgency, characterized in that the plurality of electrodes is arranged so that transcutaneous electrical stimulation is applied between the first and second electrode zones to neuromodulate the tibial nerve and the plantar nerves,And because the heel cup-type support body has an ambidextrous design that allows it to be placed interchangeably on the right or left foot by means of a substantial 180° rotation around its longitudinal axis, maintaining in both cases the anatomical alignment of the first electrode zone with the region adjacent to the tibial nerve and of the second electrode zone with the plantar region.

2. Device according to claim 1, intended for the management of overactive bladder syndrome and / or urinary incontinence Urgent, through the application, intermittently and activated on demand, of electrical nerve stimulation impulses in response to episodes of urinary urgency perceived by the user during the performance of daily life activities.

3. A device according to any of the preceding claims, wherein the remote activation device is portable and configured to remain within the user's reach at all times and comprises a single manually operated organ, said remote activation device being configured so that, when the user operates said organ, it sends commands to the electrostimulator to start and stop the delivery of the electrical nerve stimulation impulses, the intensity, frequency, and pulse width parameters of said impulses remaining preset in the electrostimulator, while the duration of each stimulation episode is determined by the time interval during which the user keeps said organ operated, allowing the user to activate and deactivate the stimulation without having to directly manipulate the electrostimulator or interrupt walking or the activity being performed.

4. Device according to any of the preceding claims, wherein the body or heel-type support comprises at least a first electrical connector and a second electrical connector intended to be selectively connected to the electrostimulator, said connectors being associated respectively with the first and second electrode zone, so that, depending on which of the connectors is coupled to the electrostimulator, the direction of the passage of the electrical impulses of nerve stimulation is defined between the first electrode zone located in the region adjacent to the tibial nerve and the second electrode zone located in the plantar region, allowing the direction of the current to be adapted to the use of the device in one or the other foot.

5. Device according to any of the preceding claims, wherein the electrostimulator is configured to operate in at least: a first programmed session operating mode, in which it delivers a sequence of electrical nerve stimulation pulses with a predetermined duration and parameters independently of user activation; and a second on-demand operating mode, in which the delivery of the electrical nerve stimulation pulses is initiated and stopped exclusively in response to commands from the user-operated remote activation device. [0001] [0002]Declaration pursuant to Article 19(1) [0003]The claims have been amended to more accurately reflect the inventive concept of the application and to delimit the invention from the known state of the art. [0004]The amended set of claims defines an ambulatory neuromodulation system comprising an anatomical heel cup-type support that surrounds the ankle and heel, provided with a first electrode zone located, in use, adjacent to the tibial nerve proximal to the medial malleolus and a second electrode zone located in a plantar region through which plantar nerves originating from the tibial nerve run. A portable, rechargeable electrostimulator is connected to said plurality of electrodes to generate electrical impulses for nerve stimulation. [0005] An essential element of the invention is the presence of a wireless, portable, remote activation device designed to be kept within the user's reach, configured exclusively to initiate and stop the delivery of electrical impulses. The intensity, frequency, and pulse width parameters are preset in the electrostimulator. Thus, the duration of each stimulation episode is determined by the time the user keeps the device activated, allowing for intermittent, on-demand neuromodulation during ambulation, in direct response to episodes of urinary urgency for the management of overactive bladder syndrome and / or urge urinary incontinence. [0006]Likewise, the heel pad features an ambidextrous design and a connection architecture that allows the direction of current flow between the tibial and plantar areas to be selected according to the foot, and the electrostimulator is configured to operate at least in a programmed session mode and in an on-demand mode controlled exclusively by the remote activation device.

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