Devices for neuromodulation therapy

Abstract

To provide a neuromodulation device for medical treatment of lower urinary tract dysfunction.SOLUTION: The neuromodulation device includes a pulse generator, a control unit for controlling the pulse generator, and at least one active electrode connected to the pulse generator. The active electrode has an electrically conductive surface that is attached to a leg of a patient and stimulates nerves in the patient's leg with electrical pulses. The device further includes a response detector that detects a reflex movement of the stimulated leg in response to the neural stimulation and provides feedback to the control unit. The control unit changes an initial setting of at least one parameter of the electrical pulse until the detected reflex movement of the stimulated leg falls within a predetermined range so that a stimulation setting is determined in a first phase, and in a second phase, the determined stimulation setting is maintained for a predefined stimulation time, provided that the detected reflex movement of the stimulated leg remains within a predetermined range.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a neuromodulation device for stimulating neurons in a patient's body with electrical currents having parameters that are best suited for a particular disease and human treatment and that are set based on the patient's physical feedback. The present invention also relates to methods of using the neuromodulation device to enable the treatment of diseases. [Background technology]

[0002] The use of electrical stimulation of neurons to benefit human subjects is described, for example, in U.S. Pat. Nos. 13,704,337 and 7,257,448, for treating incontinence, stimulating muscles for purposes of simulating exercise and the subsequent increase in heart rate, improving lymphatic drainage in the lower extremities, stimulating neurons, and other related uses associated with the positive effects of electrical current.

[0003] The percutaneous tibial nerve stimulation (PTNS) method for treating incontinence uses a needle introduced adjacent to a nerve in the talocrural region and, via an electric current connected to it, stimulates that nerve as well as adjacent nerves in the pelvic region. This repeated stimulation of the pelvic region can have a significant positive effect on both muscle function and communication between the patient's body and nervous system. Improvement in bladder function through stimulation using an electric current is achieved through repeated sessions lasting several minutes. Historically, the disadvantages of inserting a needle into a patient's body primarily include pain, the risk of nerve damage, and the need for a medical professional to perform the treatment. For successful treatment, it is important to ensure accurate targeting of the nerve to be stimulated. In practice, the patient's subjective sensation is used, and most importantly, plantar flexion caused by nerve stimulation is observed. However, this is not always accurate and has proven to be the greatest obstacle to achieving the highest success rates.

[0004] WO 2015 / 066597 describes a device for measuring responses to nerve stimulation. However, the two small perianal electrodes described therein are arguably a difficult solution to implement without the presence of a trained medical professional. The device receives signals from a digital input and stores at least a portion of the signals in memory. It thus keeps a record of the current procedure being performed via a sensor module and initiates real-time transmission of at least a portion of the record to or from the sensor module via a communications device to determine whether the desired stimulation (compound muscle action potential) has been achieved.

[0005] An example of a detector for contact reading of reflex movements of muscle groups and generating electrical signals for feedback control of impulse stimulation frequency in a resonant configuration is described in WO2013 / 113297.

[0006] Electromyographic devices for the detection of a patient's body signals are described in documents US20150126894, US5800470, and document WO2005023087 provides an improvement to electromyographic devices.

[0007] Until now, such devices have required professional application and setting of current parameters based on the patient's verbal assessment or observation. Alternatively, they can be set to a preset average value for all patients, but this is not suitable for everyone. For example, patients with abnormalities such as high body weight or high skin resistance may experience poor results from treatment. Therefore, it is necessary to adapt the electrical charge to individual needs. This problem is solved by the system and method for setting these parameters described below.

[0008] Furthermore, the historical methods described above tend to have lower therapeutic efficacy. Neurostimulation is applied using only one active electrode per branch of the sciatic nerve or per limb. Such treatment methods prolong treatment times and require multiple treatment sessions, thus causing inconvenience to both the patient and / or medical staff.

[0009] The use of neuromodulation in the treatment of overactive bladder syndrome is well known in modern medicine. The percutaneous tibial nerve stimulation (PTNS) technique for treating incontinence uses a needle introduced adjacent to a nerve in the talocrural region and, via an electric current connected to it, stimulates that nerve as well as neighboring nerves in the pelvic region. This repetitive stimulation of the pelvic region can have a significant positive effect on both muscle function and communication between the patient's body and nervous system. Improvement in bladder function through electrical current stimulation is achieved through repeated sessions lasting several minutes. Historically, the disadvantages of inserting a needle into a patient's body primarily include pain, the risk of nerve damage, and the need for a medical professional to perform the treatment. For successful treatment, it is important to ensure accurate targeting of the nerve to be stimulated. In practice, the patient's subjective sensation is used, and most importantly, plantar flexion evoked by nerve stimulation is observed. However, this is not always accurate and has proven to be the greatest obstacle to achieving the highest success rates. In the PTNS technique, the impulse length is approximately 0.2 ms.

[0010] Another method for treating overactive bladder syndrome is sacral nerve stimulation. This method is based on the subcutaneous implantation of a programmable stimulator to stimulate the sacral nerves, specifically the S3 dermatome. Sacral nerve stimulation is disadvantageous primarily due to the need for invasive surgical intervention. Furthermore, the batteries that provide the electrical energy for stimulation must be replaced, requiring repeated surgical intervention.

[0011] There are methods for treating incontinence through stimulation of the tibial or other nerves. For example, a method for treating incontinence is described in U.S. Patent No. 8,660,646. However, these methods have not yet demonstrated sufficient therapeutic efficiency. Furthermore, this method does not allow for the setting of nerve stimulation parameters according to the individual needs of the patient. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] U.S. Patent No. 13,704,337 [Patent Document 2] U.S. Patent No. 7,257,448 [Patent Document 3] WO2015 / 066597 [Patent Document 4] WO2013 / 113297 [Patent Document 5] U.S. Patent No. 20150126894 [Patent Document 6] U.S. Patent No. 5,800,470 [Patent Document 7] WO2005023087 [Patent Document 8] U.S. Patent No. 8,660,646 Summary of the Invention [Means for solving the problem]

[0013] The present invention provides a device for stimulating peripheral nerves, comprising a memory unit, at least one electrode attached to a patient's body for generating pulses, and a control unit connected to the electrodes for setting at least one electrode pulse parameter, the control unit further connected to at least one response detector to neuromodulation. The response detector to neuromodulation is connected to the control unit for transmitting information regarding a frequency value of movement of at least a portion of the patient's body. The control unit of the device further automatically sets the current flow of the electrode pulse in response to the information regarding the frequency value of movement of at least a portion of the patient's body.

[0014] The control unit receives information about the frequency values ​​from the neuromodulation response detector or from memory. The detector of the device can be an optical sensor, an infrared sensor, an accelerometer, or a capacitive, inductive, temperature, flow, ultrasonic, or magnetic sensor. In alternative embodiments of the invention, an electromyograph can also be used as the detector. In a preferred configuration, the detector can use two or more sensors.

[0015] The memory device may be at least one of the following: an HDD disk, an SSD disk, a flash memory, a memory card, RAM, a CD, a DVD, or a Blu-ray. In an alternative configuration, the memory may be a remote storage device accessible via a network service.

[0016] Alternatively, the remote memory storage unit may be accessible via another neuromodulation device connected to a network service.

[0017] The control unit varies the frequency of the electrode pulses until it is substantially equal to the frequency of the recorded movement. The control unit also varies the current flow of the pulses until it reaches the optimal frequency of the recorded movement.

[0018] The device may include one or more separate control units. The control unit may be part of a controller that may further include a display device and a user input for an operator. According to the present invention, the control unit sets the frequency of the pulses within a range of 0.1 to 100 Hz and the length of the pulses within a range of 0.1 to 10 ms. According to the present invention, the control unit may further set the shape of the pulses. The control unit of the device may further set the polarity of the voltage, which varies from positive to negative.

[0019] The control unit communicates with a database stored in a memory, either internal to the control unit or in a remote storage unit available via a network service. The database stores information regarding recommended pulse current flow parameters. The database may further include patient personal data, such as, but not limited to, information regarding the patient's age and gender, and information regarding the patient's identity and personal data, such as identification number, insurance number, address, social security number, credit card number, etc. According to the present invention, the control unit transmits information from the database to the remote storage. According to the present invention, the detector and controller are part of a single configuration. According to one embodiment, the controller and at least one electrode are part of a single unit. Such a single unit may be electrically and mechanically connected devices. In some embodiments, the single unit may also be integrated into a single configuration.

[0020] The present invention further provides a method for treating symptoms of overactive bladder in a human using a neuromodulation device. Specifically, the method relates to treating symptoms of overactive bladder, in which the neuromodulation device includes a control unit and at least two electrodes capable of generating electrical pulses. According to the present invention, active electrodes are attached to a patient's body such that a first active electrode is attached to one of the patient's legs and a second active electrode is also attached to one of the patient's legs. After the active electrodes are attached, a first electrical pulse in the first active electrode is delivered to the patient's body, and simultaneously or subsequently, another electrical pulse in the second active electrode is delivered to the patient's body. In a next step, a pulse current flow is set. A preferred method further includes a step of synchronizing the timing of each pulse.

[0021] In one embodiment, the active electrodes are attached near a branch of a peripheral nerve. In one preferred embodiment, the active electrodes are attached to the patient so that a first active electrode is attached to a first branch of the sciatic nerve and a second active electrode is attached to another branch of the sciatic nerve. In one embodiment, one of the following nerves is stimulated: the lumbosacral plexus, sciatic nerve, common peroneal nerve, tibial nerve, pudendal nerve, superior gluteal nerve, inferior gluteal nerve, posterior femoral cutaneous nerve, obturator internus nerve, piriformis muscle, quadratus femoris nerve, plantar nerve, or coccygeal nerve. In a preferred embodiment, the pudendal nerve, tibial nerve, or common peroneal nerve is stimulated.

[0022] In one embodiment, a first active electrode is attached to one leg of the patient and a second active electrode is attached to the other leg. In another embodiment of the method, a first active electrode is attached to a first leg of the patient and a second active electrode is also attached to the same leg.

[0023] According to the present invention, the active electrode is a transcutaneous electrode, a percutaneous electrode, or a chronically implanted electrode. According to the method, a first electrode is attached to the back of one knee and a second active electrode is attached to the back of the other knee. In one preferred embodiment, synchronization of the electrical pulses is achieved by aligning the pulses with the beginning of each pulse. In another preferred embodiment, the timing of the pulses is synchronized according to the time of delivery of the pulse from the first active electrode and the time of delivery of the pulse from the other active electrode in the target area. In one embodiment, the target area is the sacral plexus or sciatic nerve. According to one embodiment, the present invention further includes placing a ground connector on the patient's body, most preferably in the suprapubic, abdominal, or sacral region of the patient.

[0024] According to one embodiment, the electric pulses have a frequency between 0.1 Hz and 100 Hz, a pulse width between 0.1 ms and 5 ms, a current between 0 mA and 250 mA, and a voltage between 0 V and 90 V. The frequency of the electric pulses is most advantageously between 2.5 Hz and 60 Hz, and the pulse width of the electric pulses is between 0.1 ms and 2.5 ms. 2 In one embodiment having an active surface greater than 0.5 cm, the electrical pulse has a current between 15 mA and 250 mA. 2 and 2cm 2 In other of the embodiments having an active surface between 0 and 15 mA, the electrical pulse has a current between 0 and 15 mA. 2 In one embodiment having an active surface of less than 1000 nm, the electrical pulse has a current between 0 mA and 5 mA.

[0025] In a preferred embodiment, the electrical pulses have a substantially rectangular or right-angled triangular shape and are monophasic or biphasic. According to a preferred embodiment, the duration of the pulses is determined by an algorithm stored in the memory of the control unit.

[0026] In one embodiment, the method further comprises the following steps for accurate positioning of the first and second active electrodes: After attachment of either of the active electrodes, an electrical pulse is generated, and then a reflex movement of at least a portion of the patient's body is monitored; the sufficiency of the reflex movement of the monitored portion of the patient's body is determined; if the reflex movement of the monitored portion of the patient's body is insufficient, the active electrode is repositioned; the steps are repeated until the movement of at least a portion of the patient's body is sufficient, and thus until an optimal position for the active electrode is achieved. The present invention further provides a method for collecting information regarding the use of a medical device, such as a neuromodulation device according to the above claims, other similar neuromodulation devices, or other medical devices. The method comprises the following steps: Information from a control unit is collected; The information is sent from the control unit to a memory; The information is stored in a database; and The information is then retrieved from the database. In one embodiment, the medical device is a therapeutic medical device, a surgical medical device, or a diagnostic medical device. The control unit can communicate with the memory using any of the following means: GSM, Bluetooth, radio frequency, infrared communication, LAN, USB, or wireless internet connection. In one embodiment, the method further includes assigning an identification number to the patient, medical device, or information. In one embodiment, the method further includes storing the information in the device's memory and connecting the medical device to another medical device. In one preferred embodiment, the information relates to treatment received and includes at least one of the group consisting of pulse current, current intensity, and pulse frequency. In another embodiment, the method further includes evaluating the information stored in the database and using the information for billing purposes. Another embodiment of the invention further includes using the information stored in the database to transmit information to the patient's physician and / or to the patient's electronic medical record.In another embodiment, the method further comprises using the information stored in the database to automatically modify parameters of the treatment or use of the device. [Brief explanation of the drawings]

[0027] [Figure 1] 1 shows a first embodiment of an electrode according to the invention; [Figure 2] FIG. 1 shows the same view from below. [Figure 3] FIG. 1 illustrates radiation emitted by an electrode. [Figure 4] 10A-10C show alternative embodiments of electrodes. [Figure 5] FIG. 1 shows a device according to the invention. [Figure 6] FIG. 1 shows an assembly of optical sensors within a detector. [Figure 7] FIG. 1 shows an assembly of an ultrasonic sensor within a detector. DETAILED DESCRIPTION OF THE INVENTION

[0028] The present invention includes three main components, as shown in Figure 5. The first component is a control unit 13, the second component is a detector 14, and the third component is an electrode 15. The electrode can be of two types. A first possible embodiment of the electrode is shown in Figure 4, which includes a magnet 3, a pole piece 4, a first pole 1 of the electrode, and a second pole 8 of the electrode. The role of the magnet 3 is to increase the depth range at low stimulation currents. Together with the pole piece 4, it linearizes and concentrates the radial electric field lines in the axial direction around the axis of the first pole 1 of the electrode. This essentially creates a tunneling effect, which directs the movement and concentration of ions as charge carriers into the intercellular space. In this embodiment, the magnet 3 is permanent and has the shape of a hollow cylinder, with the first pole 1 of the electrode, for example, made of copper or brass, passing through its center. In the area of ​​contact with the skin, the first pole 1 of the electrode is preferably circular and coated with a layer of a suitable material, such as silver. The outer casing and the side of the permanent magnet 3 away from the skin are surrounded by a pole piece 4 made of diamagnetic material. The first pole 1 of the electrode is threaded from the side away from the skin for attaching a nut 6 and terminates in an adapter 7 for connecting a wire 2. Alternatively, the first pole 1 of the electrode is fixed by combining it with a spring and an additional base. The first pole of the electrode is unthreaded and has a locking edge that matches at least a portion of the additional base, where the first pole 1 of the electrode is fixed by a biasing spring member such that the spring member generates tension between the first pole 1 of the electrode and the fixing element 5, directly or indirectly. Thus, a force is applied between the locking edge of the first pole 1 of the electrode and at least a portion of the additional base, resulting in the fixation of the first pole 1 of the electrode. The annular second pole 8 of the electrode is fixed to the fixing element 5 while being separated from the first pole 1 of the electrode by a gap or another insulator. It is therefore a bipolar electrode with fixed positions of the electrode's first pole 1 and electrode's second pole 8. The magnet 3 is separated from the electrode's first pole 1 by an insulator and possibly also by an air gap. The magnet 3 is oriented with its north pole facing the tissue.The first pole 1 of the electrode, the magnet 3, the pole piece 4, and the second pole 8 of the electrode are made of materials intended for medical use and are electrically insulated from each other except for the area of ​​the pole of the magnet 3 that is in contact with the pole piece, and the insulators are of a biocompatible material that can also withstand frequent sterilization and is preferably water resistant.

[0029] Preferably, the magnet 3 is in the form of an electromagnet. As will be apparent to those skilled in the art, using a suitable source 9, it is possible to set the shape of the area with the highest concentration of charge carriers, i.e., a type of channel, by means of adjustable magnetic excitation. Furthermore, if several electromagnets are used, their different excitations can influence the direction of current flow into the tissue, i.e., the direction of such a channel. For example, this can be used to locate the desired nerve even in the event of an imprecise placement of an electrical stimulation device on the skin.

[0030] A DC power supply 9 is connected between the first electrode pole 1 and the second electrode pole 8. The frequency can be set between 1 Hz and 15 Hz, and the pulses can be monophasic or biphasic, for example, square, sinusoidal, or triangular waves with exponential ramps and widths of 0.1 ms to 5 ms, with a current range of 0 mA to 50 mA. A frequency of 2 Hz to 6 Hz appears to be the most preferable and is very efficient.

[0031] The device further includes a harness that secures the device in a specific location and a power supply. Proper placement of the electrical stimulation electrodes is crucial for the overall efficiency of the method and to eliminate the risk of a decrease in the method's efficiency due to improper handling of the electrodes. The role of the fixation element 5 is to ensure repeated attachment of the electrodes to the same electrical stimulation site. To create a shape that permanently fits the patient and ensure equal conditions for each stimulation session, a special harness is used that can use the shape of the human body as a fixation point to fix the position of the electrodes.

[0032] Another electrode embodiment is represented by one with a conductive magnet. This example of the geometric arrangement of the active components is shown in Figures 1 and 2 and includes a diamagnetic wedge 10, a main magnet 11, and a pole piece 4. These components provide increased penetration depth for the current flowing between the diamagnetic wedge 10 and the passive conductive contact 12, even at low stimulation currents. Due to their configuration, they are able to linearize and concentrate the radial electric field lines axially around the axis of the main magnet 11. This results in ion channels with limited diameter and direction for ion migration due to the magnetic field. Thus, as charge carriers into the intercellular space, ions move along trajectories determined by the magnetic field lines. The diamagnetic wedge 10 has two functions: it deflects the magnetic field lines from the axis of the main magnet 11 and provides electrical contact with the skin. In this example, the diamagnetic wedge 10 is made of copper and has a cylindrical shape with a rounded end adjacent to the tissue for better contact with the skin and maximum patient comfort. As can be seen in Figure 2, the diamagnetic wedge 10 is positioned so that it is completely or at least substantially surrounded by the magnetic field of the main magnet 11. To perform its function while remaining easy to maintain, it is further covered with a layer of gold or other electrically conductive, non-toxic, and inert material. The outer casing and base of the main magnet 11, away from the skin, are surrounded by a pole piece 4, preferably made of diamagnetic material. The side of the diamagnetic wedge 10 away from the skin is connected to the main magnet 11 by conductive adhesive or other conductive connection, which, in addition to the above-mentioned effects, also prevents so-called magnetic short circuits on the side of the main magnet 11 facing the skin. In this example, the passive conductive contact 12 of the electrode is embodied as a thin copper sheet that may be gold-plated, but other diamagnetic materials such as silver, gold, bismuth, carbon, and conductive plastics of various compositions can also be used. In the figure, the passive conductive contact 12 of the electrode is annular and attached to the fixing element 5, thereby separated from the main magnet 11 by a gap filled with the same insulating material from which the fixing element 5 is made.However, in other embodiments, the passive conductive contacts 12 may be represented by various types of conductive fabrics, any conductive gel, or other conductive materials commonly used in medicine. In this example, the primary magnet 11 is represented by a neodymium magnet (NdFeB). The primary magnet 11 may consist of a single magnet, or in alternative embodiments, several adjacently arranged magnets, with their north poles oriented toward the tissue. The electrode's fixation element 5 and the passive conductive contacts 12 are made from materials intended for medical use, which are preferably waterproof and resistant to frequent sterilization. Figure 3 shows the lines of force of the electrical stimulation device.

[0033] A voltage source 9 is connected to the device between the diamagnetic wedge 10 and the passive conductive contact 12. Its output signal shape and frequency are adjustable. Preferably, frequencies between 0.1 Hz and 100 Hz are used, and pulses can be monophasic or biphasic. The pulse shape can be square, sinusoidal, or triangular, with exponential rise or fall slopes and widths of 0.1 ms to 5 ms, or more precisely, 1 ms to 3 ms, with amplitudes of 0 mA to 50 mA. Frequencies between 1 Hz and 15 Hz, or more precisely, 2-7 Hz, appear to be the most favorable and highly effective, although individual adjustment plays an important role, as each patient may respond optimally to different frequencies.

[0034] Another example is an electrical stimulation device solution that does not include a diamagnetic wedge 10 and is therefore suitable for other applications in addition to those described above, such as stimulating superficial nerves, improving absorption of substances through the skin, and better supplying nutrients to the skin. For non-invasive electrical connection with tissue, this embodiment considers the base of the main magnet 11 to be in direct contact with the skin. In the illustrated embodiment, the main magnet 11 is adapted for non-invasive electrical connection to tissue by including a diamagnetic wedge 10 on its skin-facing side, i.e., the side intended to be applied to the skin. In this embodiment, the main magnet 11 is adapted for non-invasive electrical connection to tissue by being coated on at least a portion of its surface, i.e., the side intended to be applied to the skin, with epoxy resin, conductive plastic, or a metal such as nickel, silver, carbon, gold, or platinum. This is again a bipolar electrode in which the main magnet 11 and the passive conductive contact 12 are firmly fixed relative to each other within the fixation element 5, which is advantageous for restimulation of specific sites. As with the other embodiments, the pole pieces 4 of the main magnet 11 can be used to enhance the effect of the magnetic field as described above, although their use is not required for all applications.

[0035] The fixation elements may be made from plastic, rubber, or other materials such as neoprene straps or disposable tape that are glued or otherwise attached together.

[0036] The device is not intended to treat stress incontinence, but rather urgency-type incontinence or overactive bladder (OAB), caused, for example, by hypersensitivity in neural receptors in the bladder. Due to dysfunction of these receptors, receptors in the brain send erroneous signals that trigger urgent bladder contractions, even when the bladder is one-quarter full. The patient then feels an urgent need to go to the bathroom, or, in some cases, leaks urine. The goal of stimulation using the proposed device is to transmit signals through afferent pathways to the brain, which then reboot the receptors in the bladder, which then return to their normal state.

[0037] The electrode 15 system and detector 14 are connected via a control unit 13, which controls the entire system. As mentioned above, the system can include a single electrode 15 or multiple electrodes 15. These can be percutaneous, transcutaneous, or implantable. Even when using a single electrode 15, it is possible to determine the optimal frequency, but for clinically effective stimulation of peripheral nerves, it is necessary to use two electrodes. The electrode 15 is connected to a pulse generator 18. The latter can be of two types: the generator 18 is directly part of the electrode 15, i.e., it is located within the electrode 15, or it is external. The external pulse generator 18 can be located within the controller 16, or in the case of an implantable electrode 15, it remotely powers the stimulator.

[0038] The detector 14 is composed of a sensor 17. In an embodiment of the present invention, the sensor 17 is an optical sensor 17. The optical sensor 17 can have several embodiments, but most preferably, it is an optical barrier. The assembly of the optical sensor 17 is shown in detail in FIG. 6 and will be described below in the description of the invention. Generally, the optical barrier includes a transmitter and a receiver. The transmitter includes a generator 18, an amplifier 19, and an infrared diode 20 with optics. The generator 18 is set to a frequency of 38 kHz. The receiver includes an aperture 21, a focusing lens 22, an infrared filter 23, a preamplifier 24, a frequency filter 25, a demodulator 26, a level converter 27, and a programmable retarder 28. The frequency filter 25 is set to 38 kHz. The following components, namely, the focusing lens 22, the infrared filter 23, the preamplifier 24, the filter 25, and the frequency demodulator 26, can be implemented as a single component. In this transmitter and receiver system, the foot 31 is positioned between the transmitter output and the receiver input. Other types of optical barriers, such as reflective optical barriers, are not excluded by the present invention. When using reflective optical barriers, the optical sensor 17 can consist of a single sensor 17 or multiple optical sensors 17 arranged at various intervals on the detector 14. Each optical sensor 17 of the reflective optical barrier simultaneously functions as both a transmitter and a receiver. This allows for the detection of objects that enter the vicinity of the sensor 17. A first advantage of embodiments with multiple optical sensors 17 is that the detector 14 does not need to be precisely positioned relative to the patient by the operator, as is the case when using only one sensor 17. Another advantage is that more detailed information about movement is received from several sensors 17, which can be further processed by the control unit 13. In general, the use of optical sensors 17 is advantageous in terms of ease of use, as the sensors 17 detect objects with good accuracy even when the distance from the sensor 17 can vary by several centimeters each time. These optical sensors 17 are based on the transmission of light in the infrared or other spectrums. The sensor 17 may also be supplemented with a polarizing filter. In addition to the standard infrared sensor 17, a camera may also be used as the optical sensor 17.The camera may include a CCD or CMOS camera with sufficient resolution. Furthermore, the optical sensor 17 may be configured to function in the infrared range without signal modulation, with signal modulation for increased resistance to overloading of the optical barrier by ambient light, or with signal modulation for increased resistance to overloading of the optical barrier by ambient light.

[0039] In one possible configuration, the sensors 17 can be arranged one after the other. The sensors 17 are placed on holders, through which the sensors 17 are firmly attached to the rest of the structure. The holders with the sensors 17 can be adjusted by fastening or locking elements. The entire system then records the movements of the lower limbs in their vicinity.

[0040] In an alternative embodiment, the sensor 17 is an accelerometer attached to the patient's body. The use of an accelerometer is more user-friendly than other sensors. The accelerometer can be attached to the patient's body using a band, which may incorporate the accelerometer. Furthermore, the accelerometer can detect small changes in position. The accelerometer is attached to a portion of the leg, and the movement resulting from the stimulation is measured by the accelerometer. In alternative embodiments, a capacitive sensor, an inductive sensor, a temperature sensor, a magnetic sensor, or a direct use of an ultrasonic sensor 17 or an electromyograph may be used. A disadvantage compared to an optical sensor 17 is the small distance at which the sensor 17 can detect an object. An example of an ultrasonic sensor 17 is shown in FIG. 7. Such a sensor 17 includes a 50 kHz generator 18, an exciter 29, a primary piezo element 30 and a secondary piezo element 32 with a resonant frequency of 50 kHz, an amplifier 33, a 50 kHz frequency filter 34, a demodulator 26, a level converter 27, and a programmable retarder 28. In the case of sensor 17, limb 31 is located between the first and second piezo elements.

[0041] Another advantage of sensors 17 that provide digital signals is that analog sensors 17 can only record device-induced movements through contact. Contact sensors 17 do not provide high-quality information when recording induced movements because they naturally interfere with the observed attenuation. In some cases, echoes within the sensor 17 are generated by multiple recordings of the same movement. This ultimately leads to poor detection quality and incorrect determination of an inappropriate frequency of stimulation or different voltage characteristics for stimulation. Furthermore, mechanical sensors 17 also require additional components to provide a clear, noise-free signal.

[0042] Non-contact sensors 17 or accelerometers can be used without any patient-to-patient calibration. For example, when measuring induced spastic leg movements, the measurements must be individually customized for each patient. Leg movements and physiology vary from patient to patient. When using analog sensors 17, such customization is mostly performed by mechanical / manual reconfiguration of the sensor 17. This requires the technical skills of the operator, usually a physician. As a result, the treatment period and the risk of erroneous recording by the sensor 17 increase.

[0043] For proper treatment efficiency, it is essential that the sensor 17 transmits information about frequency and, preferably, other information about the patient's body movements, such as the range or speed of movement. Misuse of the sensor 17, usually a contact sensor, as well as directly switching the patient's stimulation, constitutes a significant risk and, due to their error rate, may result in inadequate treatment. While they do not provide any information about frequency or other parameters, such as the range or speed of movement, they directly affect the activity of the electrodes 15. If the system operates using information about the frequency of the patient's body movements, it can be software-configured in various configurations and can process the information differently. This provides, among other advantages, other benefits discussed further below. To transmit information about the movement frequency, the control unit 13 must be provided with digital information. Such a device according to the present invention can be implemented in two ways: either the direct output from the sensor 17 is digital, or the analog output must be connected to an A / D converter that converts the analog signal to a digital signal and transmits it to the control unit 13.

[0044] With the digital signal from the sensor 17, the problem of adapting the measurements to each patient does not arise: all circumstances in this case are included in the individualized configuration of the control unit 13 beforehand, and the output from the sensor 17 is processed to provide relevant information without any mechanical reconfiguration of the detector 14. This applies both to the non-contact sensor 17 and to the accelerometer, which may be attached to the foot 31.

[0045] The sensor 17, which detects the movement of the stimulated limb, transmits the information to the control unit 13, where it is processed for further use. The control unit 13 uses the information to directly control the electrodes 15 attached to the patient as feedback for effective neuromodulation of the peripheral nerve. The evoked leg movement provides clinical information that the set frequency of the stimulation current is correct. Therefore, the control unit 13 is guided to read the frequency spectrum between preset limits. These values ​​are already set at the factory: 1 Hz and 100 Hz. The control unit 13 controls the electrodes 15 in two stages: the recognition stage and the treatment stage. In the recognition stage, the device searches for the ideal frequency or other parameters of current flow for the individual patient based on feedback from the sensor 17. The control unit 13 includes setting rules that define when the neuromodulation frequency is considered optimal for the patient. Ideally, it would be able to detect each stimulation as a seizure. Once the control unit 13 recognizes the ideal frequency, it switches to a treatment regime. In this mode, the control unit 13 maintains the detected frequency, thus resulting in peripheral nerve stimulation without further change. This phase can typically take 30 minutes. In some cases, for sufficient efficiency of clinical treatment, this may only take about 2 minutes. The control unit 13 can be configured to include a condition such that once the ideal positive feedback linkage from the sensor 17 disappears, the control unit 13 returns to the first recognition phase and sets the adjacent frequency to the originally identified frequency.

[0046] In addition to the frequency, the control unit 13 also sets other parameters of the pulse. One of them is the pulse length, which can range between 0.1 ms and 10 ms. Another factor controlled by the control unit 13 is the pulse shape. The control unit 13 also sets the voltage polarity, which varies from positive to negative. Unlike direct current stimulation, biphasic current does not cause tissue electrolysis, which can potentially lead to skin problems (skin inflammation, infection), presenting a problem for sensitive patients. The control unit 13 is configured to calculate the optimal flow of pulse current x, with the opposite polarity to counteract the effects of electrolysis. This mechanism is also known as a "charge-balanced pulse." This feature makes the device safer.

[0047] In a preferred embodiment, the control unit 13 sets up a stream of pulse rounds or bursts, for example 20 pulses applied over a very short time period. For longer time intervals, these pulse bursts appear as single pulses of irregular shape.

[0048] For the pulse settings described above, a control unit 13 is required to command these parameters. As inputs for the specific settings, the control unit 13 uses information from the controller and information about the frequency of limb movements from the sensor 17.

[0049] Clinical studies have shown that for effective treatment, patients suffering from incontinence require approximately five repeated treatments before permanent improvement can be achieved. This necessarily requires administering treatment to the patient over time, again going through the recognition and treatment phases of therapy. Therefore, the control unit 13 includes a memory unit that allows staff to store data about a single patient, including information about at least one identified ideal parameter for that patient. The memory of the present invention can be any type of data storage, either local or remote. These storage devices include HDD and SSD hard drives, flash memory, memory cards, RAM devices, CDs, DVDs, Blu-ray discs, etc. Remote storage units include those that are only accessible by connecting the device to a local network, the Internet, or GSM, such as cloud storage. A local network, the Internet, or GSM can all be understood as network services. A network can also be created by several of the presented neuromodulation devices, where one of the neuromodulation devices is connected to remote storage and the others are connected to this neuromodulation device. The indirect connection of the other neuromodulation devices connected to the remote storage is preferably wireless. The other neuromodulation devices communicate with the remote storage unit via the first neuromodulation device. The first neuromodulation device then redirects data from the remote storage unit to the other neuromodulation devices connected to the first neuromodulation device according to the identification portion of the communication data.

[0050] The stored information about the patient effectively reduces the time required to perform the treatment and can also serve as an additional home therapy. In some cases, patients can purchase electrodes 15 intended for home use themselves, allowing the patient or a family member to use them. This type of device also includes a control unit 13 that can use the stored information about the identified stimulation parameters and adjust the therapy accordingly. Input of this information into the device depends on the selected storage method, which is not particularly limited by the present invention. In a preferred embodiment, it may be, for example, an SD memory card inserted into the device in the examination room to identify ideal stimulation parameters and then inserted into the device for home use, and the appropriate treatment settings will follow the identified stimulation parameters. In another preferred embodiment, the selected storage device may be, for example, a cloud memory. Stimulation parameters may be entered into cloud storage via the device and made accessible in the clinic or at home by the same or any other device. The cloud storage and the stimulation parameters entered therein may also be accessible via a computer, tablet, mobile phone, or other electronic device connected to the cloud storage.

[0051] In addition to reducing the duration of treatment, storing patient data has other advantages. Thanks to the determination of individual stimulation parameters, this information does not need to be stored in a separate patient file. At the patient's next visit, the information can simply be automatically retrieved from the system without any search required. This also prevents errors that can arise from poor handwriting. Incorrectly set parameters will not lead to an improvement in the patient's condition. A system containing such information can be further enhanced by including statistics directly related to device use. In addition to information about specific frequencies, the system stores other parameters that affect the pulses described above, such as the polarity of the pulses, their length, shape, etc. These statistics are also stored in memory so that treatment information is available for a specific patient. The amount billed to the patient can then always be determined accurately and fairly. If an in-office device bills according to the number of treatments performed, the same applies to the amount billed to the office by the provider. It is also possible to use such information as a high-quality source for generating statistics, which can then be used for both clinical purposes and to predict future improvements in the patient's condition based on recorded treatments. Additionally, these statistics are useful for determining device utility, calculating avoided costs associated with alternative treatments, calculating service intervals, and the like.

[0052] The control unit 13 of the present invention can be integrated, or the device can include several control units 13, for example, one for the detector 14 and another for controlling the electrodes 15. If the device includes several control units 13, these units are equipped with a communication protocol for continuous information exchange. As part of the treatment device, the control unit 13 also acts as a decision maker on behalf of the physician. Analog systems require the physician to directly set parameters in response to observations of induced movements or the output of the sensors 17, leading to lower treatment efficiency.

[0053] The benefit of transmitting motion frequency information from the sensor 17 to the control electronics is increased product safety and efficiency. A mechanical sensor 17 connected to electronics that uses only the amplified signal from the sensor 17 as the excitation signal for stimulation can lead to potentially dangerous situations. Due to the higher requirements for medical devices, such an approach is not feasible in clinical situations. Therefore, the device must be equipped with a control unit 13 containing commands for various situations, thus ensuring increased security. These commands can be part of the control unit 13's software or firmware, depending on its technical level. Mechanical sensors 17 are also prone to error states. They represent a high risk, especially when recordings are used as input for electrical current stimulation. These error states can cause muscle spasms or, even worse, local burns to the patient at the electrode 15 site. Electronics that can guarantee higher safety requirements require the connection of sensors 17 that provide digital information. Using a mechanical sensor 17 and safety electronics requires another link between the sensor 17 and the control unit 13, which adds another element to the system, increasing the total cost of the device as well as the potential for increased failure rates and inaccuracies.

[0054] The device also includes a controller 16. Generally, the controller 16 represents a user input for controlling the control unit 13, which can take a variety of shapes and forms. The controller 16 comprises the control unit 13 described above. In an alternative embodiment, the control unit 13 is external to the controller 16. The controller 16 is part of the overall device structure, but need not be rigidly attached. The controller 16 may be loosely attached to the structure, but may be securable to a support structure in at least one location. In one embodiment, the controller 16 includes a display device and buttons. The buttons connected to the controller may be multi-stage, allowing two or more instructions to be given depending on the movement of the controller 16 selected by the operator. The display device is used to transfer information to the operator. After initiating treatment, the display device can show instructions for using the device so that the treatment is as effective as possible. These may be in the form of a series of instructions displayed on the display device one by one by the operator clicking a button on the controller 16. The displayed information is controlled by the device's controller 13.

[0055] Further disclosed is a method for treating incontinence using the above-described neuromodulation device and other similar neuromodulation devices. Symptoms of overactive bladder are treated, according to the present invention, using a neuromodulation device comprising at least two active electrodes capable of generating electrical pulses. The first step of the present invention is to attach a first active electrode to a patient's leg and a second active electrode to either of the patient's legs. Attaching either of the active electrodes should be understood as attaching a removable electrode to the patient's skin (percutaneously), attaching either of the active electrodes to the patient's body by percutaneously penetrating the patient's skin, or attaching either of the active electrodes by implanting an active electrode in the patient's leg for long-term implantation. Furthermore, a first electrical pulse is generated inside the patient's body at the first active electrode, and a second electrical pulse is generated inside the patient's body at the second active electrode. Furthermore, the present invention includes a step of setting the current flow of the pulses. The present invention further includes a step of synchronizing the timing of each pulse.

[0056] After generating the electrical pulse, the pulse is delivered to a branch of the patient's nerve, thus stimulating the nerve and delivering the stimulation in the form of a pulse to the target area. The target area is the sacral plexus or sciatic nerve. In preferred embodiments, the first and second electrical pulses are generated alternately, so that the interval between the electrical pulses can be as follows: first electrical pulse, then second electrical pulse, then first electrical pulse, etc. Alternatively, the interval can be as follows: second electrical pulse, first electrical pulse, second electrical pulse, etc. In some preferred embodiments, the electrical pulses can be generated simultaneously or independently, such as first electrical pulse, second electrical pulse, first electrical pulse, etc. It is important that one of the first electrical pulses and one of the second electrical pulses reach the target at the same time. The simultaneous effect of the two independently generated electrical pulses results in a much greater therapeutic effect than prior art. According to the present invention, three or more active electrodes are used, with a third active electrode attached to the patient's body, for example, a third active electrode capable of generating an electrical pulse attached to one of the patient's legs. The third electrode generates a third electrical pulse that is synchronized so that one of the third electrical pulses, one of the second electrical pulses, and one of the first electrical pulses reach the target area simultaneously. Similarly, more active electrodes can be attached to the patient's body to generate electrical pulses.

[0057] The active electrode is an electrode such as the one previously described and shown in FIG. 4 , which includes a magnet 3, a pole piece 4, a first electrode pole 1, and a second electrode pole 8. Another first embodiment of the electrode is the electrode shown in FIG. 1 and previously described. Preferably, the electrode used is a percutaneous electrode, as in the two electrodes previously described, or in another embodiment of a percutaneous electrode. Percutaneous electrodes are advantageous primarily because their use does not require invasive procedures. In yet another embodiment of the present invention, a percutaneous electrode capable of penetrating the patient's skin and generating electrical pulses is used as the active electrode. In yet another example embodiment of the present invention, the electrode is a chronically implanted electrode. The electrodes, e.g., the first electrode, the second electrode, and other electrodes, can include one or more conductors. Any type of active electrode is characterized by its ability to generate electrical pulses or deliver electrical pulses generated by a pulse generator to the patient's body. The generator can be directly part of the electrode, i.e., it can be located within the electrode, or it can be external. The external pulse generator may be located in the controller, or in the case of an implanted electrode, it remotely powers the stimulator. In embodiments of the invention using chronically implanted electrodes, the electrodes may be inductively "charged." In this embodiment, the external pulse generator is connected to an inductor, and electrical pulses are generated in the electrode by the magnetic field created by the inductor.

[0058] In preferred embodiments of the invention, the active electrodes are placed in close proximity to a peripheral nerve branch such that an electrical pulse generated by either electrode can transmit the electrical pulse to the nerve. In embodiments using percutaneous electrodes, the electrodes are placed in the knee region, for example, so that the surface of the electrode faces the peripheral nerve branch through tissue. In embodiments using percutaneous or chronically implanted electrodes, the electrodes are placed within the vicinity of the peripheral nerve branch without directly contacting the peripheral nerve branch.

[0059] In the methods of the present invention, any of the following nerves are stimulated: the lumbosacral plexus, sciatic nerve, common peroneal nerve, tibial nerve, pudendal nerve, superior gluteal nerve, inferior gluteal nerve, posterior femoral cutaneous nerve, obturator internus nerve, piriformis muscle, quadratus femoris nerve, plantar nerve, and coccygeal nerve. Stimulation of the peroneal nerve, pudendal nerve, tibial nerve, or any combination of the aforementioned nerves is most advantageous in treating overactive bladder symptoms. Nerve stimulation is achieved by delivering electrical pulses through peripheral nerve branches to distribute nerve stimulation to target areas of, for example, other sacral plexuses or the sciatic nerve. According to the present invention, electrodes can be attached to the patient such that a first electrode is attached to a first branch of the sciatic nerve and a second electrode is attached to a second branch of the sciatic nerve. In other embodiments, multiple active electrodes can be attached to multiple branches of the sciatic nerve or other nerves to stimulate target areas. The active electrodes can be attached to the same leg, or each can be attached to a different leg of the patient. In some cases, attaching active electrodes to different legs of the patient increases the healing effect, as simultaneous stimulation effects are more easily achievable.

[0060] The treatment method further includes a ground conductor placed on the patient's body. Preferably, the ground conductor is in the form of a pad. The ground pad can be placed anywhere on the patient's body. According to the present invention, the ground conductor is placed on the patient's suprapubic, abdominal, or sacral region. By placing the ground conductor in these regions, the healing effect of the method is enhanced. The ground conductor attracts the first and second electrical pulses, allowing them to reach the target region more effectively. Additionally, the ground conductor can be configured to generate an electrical pulse; in some embodiments, the ground conductor generates a positive electrical pulse, thus having a soothing effect on the patient's bladder.

[0061] In the proposed method, various electrical pulses should be used. In a preferred embodiment of the present invention, the following limitations are used for the electrical pulses: the frequency of the first electrical pulse, the second electrical pulse, or, as the case may be, the pulse generated by the third, fourth, or other electrodes is between 0.1 Hz and 100 Hz; the pulse width of the pulse is between 0.1 ms and 5 ms, the current of the pulse is between 0 mA and 250 mA, and the voltage of the pulse is between 0 V and 90 V. Because every patient responds differently to treatment due to different physiology, the pulse parameters will therefore vary for each individual patient. In one preferred embodiment, the parameters are varied over the course of the patient's treatment according to the patient's response to the treatment. Parameter adjustments can be made by the person providing the treatment or automatically by a control unit with an appropriate algorithm. For most patients, the best treatment results are achieved by using the following parameters for the pulses: a voltage frequency between 2.5 Hz and 60 Hz and a pulse width between 0.1 ms and 2.5 ms. The current of the electric pulse also depends on the type of electrode used and its surface. 2 Using electrodes with an active surface greater than 0.5 cm achieves the most effective therapeutic results using currents of the electrical pulses between 15 mA and 250 mA. 2 and 2cm 2 Using electrodes with an active surface between 0.5 cm achieves the most effective therapeutic results using currents of the pulses between 0 mA and 15 mA. 2 Using electrodes with an active surface of less than 1000 kJ / cm, the most effective treatment results are achieved using a pulse current between 0 mA and 5 mA. The shape of the electrical pulse is also important for improving treatment results, and according to the present invention, the most effective electrical pulse shape is one with a steep upslope. Therefore, advantageous embodiments should have the electrical pulse shape be substantially rectangular or substantially right-angled triangular. The pulse may be monophasic or biphasic.

[0062] In a more general embodiment of the invention, the current flow is set in response to a biofeedback signal. Such biofeedback signal may be visual or determined by sensory means. Typically, the biofeedback may be in the form of a spasm in the patient's lower extremities.

[0063] To ensure highly effective treatment, the pulses are applied to the patient's body in a synchronized manner so that the neural stimulation generated in the patient's nervous system by either the first electrical pulse and the neural stimulation generated in the patient's nervous system by either the second electrical pulse arrive at the target area simultaneously. In another advantageous embodiment of the present invention, the neural stimulation is also generated in the patient's nervous system by the synchronized tertiary electrical pulse and / or any additional electrical pulses generated by any other active electrodes. Pulse synchronization provides more effective treatment, preferably so that faster recovery and shorter treatment sessions are achieved. According to one of these embodiments, pulse synchronization can be achieved by an algorithm stored in the memory of the control unit, which sets the timing of the generation of the electrical pulses. Multiple inputs can be acquired by the algorithm, such as data from sensors monitoring biofeedback, duration, and parameters of the first electrical pulse, the second electrical pulse, and any other electrical pulses, data from the patient's previous treatment sessions, and other relevant data.

[0064] The present invention further discloses a method for positioning electrodes. First, an active electrode is attached to a patient's body. Preferably, but not exclusively, attachment is performed in the patient's knee region. After attachment, electrical pulses are generated in the active electrode. After and / or during the generation of these electrical pulses, reflex movements of the patient's body part are monitored. The reflex movements of the patient's body part may be, for example, leg spasms, and such monitoring may be performed visually or by a sensor. The monitored reflex movements, such as leg spasms, are then compared with expected reflex movements during or after the monitoring. The determination may be made by a human or an algorithm. For example, the algorithm may compare data acquired by a sensor with data stored in the memory of the control unit. For example, such data may be represented by the number of leg spasms per time period. If the number of leg spasms is equal to or greater than the number of leg spasms stored in the memory of the control unit, the reflex movements of the patient's body are considered sufficient. The control unit can then visually, audibly, or tactilely notify the person of the achievement of sufficient or insufficient reflex movement of the patient's body part. If the reflex movement of at least a portion of the patient's body is insufficient, the electrodes are repositioned on the patient's body and the steps are repeated. This method allows the user to accurately position the active electrodes to more effectively stimulate the patient's nerves.

[0065] The methods described above are also suitable for treating other conditions such as, but not limited to, bladder pain syndrome, fecal incontinence, or lower urinary tract dysfunction.

[0066] One possible exemplary embodiment of the method is further disclosed. For purposes of this exemplary embodiment, the active electrode is of a percutaneous type, and the neuromodulation device includes two active electrodes, a ground electrode, a memory unit, a control unit, a sensor for monitoring reflex movements of at least a portion of the patient's body, such as an accelerometer communicatively coupled to the control unit, and a controller for controlling the neuromodulation device. A person, such as the patient or the patient's physician, attaches the active electrodes to the patient's body. The person attaches a first electrode, for example, in the knee region of a first leg, with the active surface of the first electrode generally facing a peripheral nerve. The person further places a ground electrode, preferably in the form of a pad, on the patient's suprapubic, lower abdominal, or sacral region. The person further places an accelerometer on the patient's leg. The person then activates the device to begin generating a first electrical pulse. In this exemplary embodiment, the neuromodulation device informs the patient of the sufficiency of the induced movement of a portion of the patient's body, in this embodiment, the leg. The initial pulse is generated using parameters based on the patient's previous treatment session. If the parameters are not stored in memory, the control unit sets the parameters based on pre-set default parameters. The parameters of the first electrical pulse are the following: frequency interval between 0.1 Hz and 100 Hz, pulse width between 0.1 ms and 5 ms, current between 0 mA and 250 mA, and voltage between 0 V and 90 V. The control unit generates the first electrical pulse and modifies the pulse parameters. If, after a predetermined number of first electrical pulses and a predetermined number of parameter value changes, leg movement monitored by the accelerometer is insufficient, the device notifies the person audibly or visually, for example, by a red light, a text display, or a predetermined sound. The person then repositions the first active electrode and repeats the process until leg movement is sufficient. The neuromodulation device notifies the person of sufficient reflex movement audibly or visually, for example, by a green light or a text display. Once the first active electrode is correctly attached, the person attaches the second active electrode to the patient's body.In this exemplary embodiment, a second active electrode is attached to the patient's second leg in the knee region in the same manner as the first electrode. The second electrode is then precisely positioned using substantially the same steps as those described above for precisely positioning the first active electrode. With both active electrodes precisely positioned on the patient's body, a first electrical pulse and a second electrical pulse are directed toward the patient's body, stimulating the target area. The flow of pulse current is set manually or by a control unit. Preferably, in this exemplary embodiment, the parameters of the first and second electrical pulses are set via the control unit. In this embodiment, pulse synchronization is achieved by the control unit based on biofeedback, such as reflex movements of the patient's leg. Pulse parameters may be changed during a treatment session depending on the patient's biofeedback. A treatment session typically lasts 15 to 45 minutes.

[0067] In this exemplary embodiment, information about the therapy session may be collected and stored in a nearby or remote memory storage device for further use.

[0068] Further disclosed is a method for collecting information regarding the use of a medical device, such as the neuromodulation device described above, other similar neuromodulation devices, or other medical devices. The medical device includes a memory and a control unit. Such a medical device may be, for example, a therapeutic medical device, a surgical device, or a diagnostic medical device. The method includes a first step in which information is collected from the control unit, and then the collected information is transmitted from the control unit to the memory. After transmitting the information to the memory, the information is stored in a database. The information stored in the database is later retrieved from the database, for example, by using a control panel, a computer, or other electronic device with access to the database. The control unit can communicate with the memory using various communication protocols, such as, but not limited to, GSM, Bluetooth, radio frequency, infrared communication, LAN, USB, and wireless Internet connection. In one embodiment, the memory may be remote from the medical device, such as stored in the cloud, a remote server, or remote data storage. In one embodiment, an identification number is assigned to the medical device and / or the patient. In one embodiment, an identification number is also assigned to the specific information. According to the identification number, the memory can assign payment and appropriate treatment parameters to the patient. For example, using a medical device and a remote type memory, any medical device can call up information about the patient and adjust treatment parameters according to the patient's needs, and payment can also be directed according to the patient's identification number. Accessing the remote memory of the medical device can be achieved by connecting to a remote memory such as a cloud or by connecting to a memory adjacent to the medical device through a connection established between the medical devices.In one embodiment, several medical devices can create a communication network, one of the medical devices can connect to a memory, and other medical devices can access the memory by communicating with the one medical device.

[0069] According to one embodiment, the information stored in the database is transmitted to the patient's physician and / or electronic medical record. Automatically or upon the patient's request via the device, transmitting information is convenient for the patient and the patient's physician, especially during home treatments performed by the patient themselves. The data stored in the database can also be used to evaluate each user's progress. The information stored in the database can also provide a long-term statistical record of medical device use. Such feedback is important for manufacturers to fine-tune the device accordingly and obtain sufficient data for device development. Information used for such long-term statistics, such as data regarding the use of a neuromodulation device, can be any of the following: data regarding the number of users, data regarding the intensity of use, data regarding the number of payments, data regarding the current intensity, or data regarding the pulse frequency.

[0070] Furthermore, the present specification includes embodiments according to the following clauses: [Section 1] A neuromodulation device for stimulating a peripheral nerve, comprising: Memory and at least one electrode configured to be attached to the patient's body for generating electrical pulses; a control unit (13) connected by the electrodes, configured to set at least one electrode pulse parameter; a neuromodulation response detector (14) connected to the control unit and configured to transmit information regarding the frequency of the movement of at least a portion of the patient's body to the control unit; Equipped with A neuromodulation device, wherein the control unit (13) is configured to automatically set the current flow of the electrode pulses in response to information about the frequency of movement of at least a part of the patient's body. [Section 2] 10. The neuromodulation device of claim 1, wherein the information of the frequency is obtained from the detector (14) of response to neuromodulation or from a memory. [Section 3] 10. The neuromodulation device of claim 1, wherein the detector (14) comprises an accelerometer. [Section 4] 2. The neuromodulation device of claim 1, wherein the detector (14) comprises at least one capacitive sensor, inductive sensor, temperature sensor, infrared sensor, flow sensor, ultrasonic sensor, magnetic sensor, or optical sensor. [Section 5] 2. The neuromodulation device of clause 1, wherein the detector (14) is an electromyograph. [Section 6] 10. The neuromodulation device of claim 1, wherein the detector (14) includes at least two sensors. [Section 7] 2. The neuromodulation device according to clause 1, wherein the memory is an internal memory of the control unit (13). [Section 8] 10. The neuromodulation device of claim 1, wherein the memory is represented by at least one of the group consisting of an HDD disk, an SSD disk, a flash memory, a memory card, RAM, a CD, or a DVD. [Section 9] 10. The neuromodulation device of claim 1, wherein the memory is remote storage available via a network service. [Section 10] 10. The neuromodulation device of clause 9, wherein the remote memory storage is configured to be accessed via another neuromodulation device coupled to the network service. [Section 11] 2. The neuromodulation device of claim 1, wherein the control unit (13) is configured to vary the frequency of the electrode pulses until the frequency of the electrode pulses is substantially equal to the frequency of the recorded movement of at least a part of the patient's body. [Section 12] 2. The neuromodulation device of claim 1, wherein the control unit (13) is configured to vary the flow of current of the pulses until an optimal frequency for the recorded movement of at least a part of the patient's body is reached. [Section 13] 2. The neuromodulation device of clause 1, wherein the control unit (13) is configured to set the frequency of the pulses within a range between 1 Hz and 100 Hz. [Section 14] 2. The neuromodulation device of clause 1, wherein the control unit (13) is configured to set the length of the pulses within a range between 0.1 ms and 10 ms. [Section 15] 2. The neuromodulation device of clause 1, wherein the control unit (13) is configured to set the pulse shape to any shape from the group consisting of a rectangle and a right triangle. [Section 16] 2. The neuromodulation device of claim 1, wherein the control unit (13) is configured to set a voltage polarity ranging from positive to negative. [Section 17] The neuromodulation device according to clause 1, wherein the control unit (13) is composed of several control units. [Section 18] 10. The neuromodulation device of claim 1, further comprising a controller (16) connected to the control unit (13) configured to obtain user input. [Section 19] 19. The neuromodulation device according to clause 18, wherein the control unit (13) is part of the controller (16). [Section 20] 19. The neuromodulation device of clause 18, wherein the controller (16) includes a display device. [Section 21] 10. The neuromodulation device of claim 1, wherein the memory includes a patient database. [Section 22] 22. The neuromodulation device of claim 21, wherein the database contains information regarding treatment history and / or patient personal data. [Section 23] 23. The neuromodulation device of clause 22, wherein the control unit (13) is configured to transmit information from the database to remote storage. [Section 24] 19. The neuromodulation device of clause 18, wherein the controller and at least one of the electrodes are part of a single unit. [Section 25] 1. A method of neuromodulation treatment of symptoms of overactive bladder in a human using a neuromodulation device comprising at least two active electrodes capable of generating electrical pulses and a control unit communicatively coupled to the active electrodes, the method comprising: attaching active electrodes to the patient's body such that a first active electrode is attached to one of the patient's legs and a second active electrode is also attached to one of the patient's legs; generating a first electrical pulse at the first active electrode relative to the patient's body and a second electrical pulse at the second active electrode relative to the patient's body; setting a current flow for said pulse; synchronizing the timing of each pulse; A method comprising: [Section 26] 26. The method of clause 25, wherein the active electrode is placed in proximity to a branch of a peripheral nerve. [Section 27] The neuromodulation pulse is 27. The method of clause 26, wherein at least one nerve selected from the lumbosacral plexus, sciatic nerve, common peroneal nerve, tibial nerve, pudendal nerve, superior gluteal nerve, inferior gluteal nerve, posterior femoral cutaneous nerve, obturator internus nerve, piriformis muscle, quadratus femoris nerve, plantar nerve, and coccygeal nerve is stimulated. [Section 28] 28. The method of clause 27, wherein the neuromodulation pulses stimulate any of the nerves, whether the pudendal nerve, the tibial nerve, or the common peroneal nerve, or any combination thereof. [Section 29] 27. The method of clause 26, wherein the first active electrode is attached to a first branch of the sciatic nerve and the second active electrode is attached to another branch of the sciatic nerve. [Section 30] 26. The method of clause 25, wherein the first active electrode is attached to a first leg of the patient and the second active electrode is attached to the other leg of the patient. [Section 31] 26. The method of clause 25, wherein the first active electrode is attached to a first leg of the patient and the second active electrode is attached to the same leg. [Section 32] 26. The method of clause 25, wherein the electrode is a transcutaneous or percutaneous electrode, or an electrode configured for chronic implantation. [Section 33] 26. The method of claim 25, wherein the first active electrode is attached to the back of one knee of the patient and the second active electrode is attached to the back of either knee. [Section 34] 26. The method of clause 25, wherein the timing of the pulses is synchronized based on a start time of each pulse. [Section 35] 26. The method of clause 25, wherein the timing of the pulses is synchronized according to a delivery time of the pulse from the first active electrode and a delivery time of the pulse from another active electrode to a target area. [Section 36] 36. The method of clause 35, wherein the target area is the sacral plexus or the sciatic nerve. [Section 37] 26. The method of clause 25, further comprising placing a ground conductor on the patient's body. [Section 38] 38. The method of clause 37, wherein the ground conductor is positioned over the patient's suprapubic, lower abdominal, or sacral region. [Section 39] 26. The method of claim 25, wherein the first and second electrical pulses have a frequency between 0.1 Hz and 100 Hz, a pulse width between 0.1 ms and 5 ms, a current between 0 mA and 250 mA, and a voltage between 0 V and 90 V. [Section 40] 40. The method of clause 39, wherein the first and second electrical pulses have a frequency between 2.5 Hz and 60 Hz. [Section 41] 40. The method of clause 39, wherein the pulse width of the first and second electrical pulses is between 0.1 ms and 2.5 ms. [Section 42] The first and second electric pulses are 2 cm 2 40. The method of claim 39, wherein the first and second electrical pulses have a current between 15 mA and 250 mA. [Section 43] The first and second electrical pulses are 0.5 cm 2 and 2cm 2 and the first and second electrical pulses have currents between 0 mA and 15 mA. [Section 44] The first and second electrical pulses are 0.5 cm 2 40. The method of clause 39, wherein the first and second electrical pulses have a current between 0 mA and 5 mA. [Section 45] 26. The method of clause 25, wherein the first and second electrical pulses have a substantially rectangular or right-angled triangular shape. [Section 46] 26. The method of clause 25, wherein the first and second electrical pulses are monophasic or biphasic. [Section 47] 26. The method of clause 25, further comprising setting the current flow corresponding to a biofeedback signal. [Section 48] 26. The method of clause 25, wherein the synchronization of the pulses is determined based on an algorithm stored in a memory of the control unit. [Section 49] generating the electrical pulse after attachment of any of the active electrodes; monitoring reflex movements of at least a portion of the patient's body; determining whether the reflex movement of the portion of the patient is sufficient; repositioning the active electrode if the reflex movement of at least a portion of the patient is insufficient; repeating said steps until at least a portion of the patient's body has been sufficiently exercised; 26. The method of clause 25, further comprising precisely positioning the first active electrode and the second active electrode, comprising: [Section 50] collecting information from the control unit; transmitting said information from said control unit to a memory; storing said information in a database; retrieving said information from said database; How we collect information about your medical device use, including: [Section 51] 51. The method of clause 50, wherein the medical device is at least one of the group consisting of a therapeutic medical device, a surgical medical device, or a diagnostic medical device. [Section 52] 51. The method of claim 50, wherein the control unit communicates with the memory using any of the group of means consisting of GSM, Bluetooth, radio frequency, infrared communication, LAN, USB, and wireless internet connection. [Section 53] 51. The method of clause 50, further comprising the step of assigning an identification number to each of said medical devices and / or patients and / or information. [Section 54] storing said information in an integrated memory of the device; connecting the medical device to another medical device; 51. The method of clause 50, further comprising: [Section 55] 51. The method of claim 50, wherein the information relates to treatment and includes at least one of the group consisting of information regarding pulse current flow, information regarding current intensity, information regarding pulse frequency, and information regarding treatment duration. [Section 56] evaluating the information stored in the database; using the information from the database for billing purposes; 51. The method of clause 50, further comprising: [Section 57] 51. The method of clause 50, further comprising using the information stored in the database to transmit the information to a patient's physician or to the patient's electronic medical record. [Section 58] 51. The method of clause 50, further comprising using the information stored in the database to automatically modify the parameters of treatment or use of the device. [Section 59] A neuromodulation device for stimulating a peripheral nerve, comprising: Memory and a pulse generator; a plurality of electrodes connected to the pulse generator, the plurality of electrodes comprising at least two active electrodes configured to be wearable on a body of the patient near a branch of at least one peripheral nerve of the patient, each of the at least two active electrodes adapted to stimulate a different branch of the at least one peripheral nerve with electrical pulses generated by the pulse generator; a control unit connected to each of the at least two active electrodes, the control unit configured to control the flow of the generated pulses to each of the at least two active electrodes; a neuromodulation response detector connected to the control unit and configured to send information regarding a reflex movement of at least a portion of the patient's body to the control unit, the reflex movement of at least a portion of the patient's body being a response of the patient's body to the stimulation of the at least one branch of the at least one peripheral nerve with electrical pulses generated by the pulse generator, the control unit being configured to automatically time the pulses within the flow of generated pulses to each of the at least two active electrodes in response to information from the neuromodulation response detector; A neuromodulation device comprising: [Section 60] 60. The neuromodulation device of clause 59, wherein the neuromodulation response detector comprises one or more sensors configured to monitor the reflex movement of a part of the patient's body. [Section 61] The neuromodulation device of clause 60, wherein the one or more sensors comprise at least one of capacitive, inductive, thermal, infrared, flow, ultrasonic, magnetic, electromyographic, and / or optical sensors. [Section 62] 62. The neuromodulation device of any one of clauses 59 to 61, wherein the at least two active electrodes comprise a first active electrode wearable on one leg of the patient and a second active electrode wearable on the other leg of the patient. [Section 63] The neuromodulation device of clause 62, characterized in that the control unit is configured to set the timing of the pulses within the flow of generated pulses to the first and second active electrodes so that the reflex movements of both feet are synchronized in response to the stimulation of the branch of the at least one peripheral nerve with an electrical pulse. [Section 64] 64. A neuromodulation device according to any one of clauses 59 to 63, characterized in that the control unit is configured to set a pulse rate for pulses generated by the pulse generator. [Section 65] 65. The neuromodulation device of any one of clauses 59 to 64, wherein the plurality of electrodes further comprises a ground electrode attachable to the patient's body. [Section 66] 66. A neuromodulation device as described in any one of clauses 59 to 65, characterized in that the control unit is configured to communicate with the memory and store in or receive from the memory information regarding the treatment received by the patient, identification information of the patient, and / or at least one of the pulse current, current intensity, pulse frequency, and treatment duration. [Section 67] The neuromodulation device of clause 66, characterized in that the control unit is further configured to automatically modify parameters of treatment or use of the device using information stored in a database. [Section 68] 68. A method of operating a neuromodulation device according to any one of clauses 59 to 67, comprising the steps of: applying a first active electrode to the patient proximate a branch of a first peripheral nerve; applying a second active electrode to the patient adjacent to another branch of the first peripheral nerve or adjacent to a branch of a second peripheral nerve; generating pulses with a pulse generator connected to the first and second active electrodes to stimulate branches of the first and / or second peripheral nerve; controlling, via a control unit, the flow of the generated pulses to each of the first and second active electrodes; detecting a reflex movement of the patient in response to the stimulation of the branch with electrical pulses generated by the pulse generator; timing the pulses within the flow of generated pulses to each of the first and second active electrodes based on information from the detector; A method comprising: [Section 69] collecting information from the control unit; transmitting the information from the control unit to a memory; storing said information in a database in said memory; receiving the information from the database; 69. The method of claim 68, further comprising: [Section 70] evaluating the information stored in the database; using information from said database for billing purposes; 70. The method of claim 69, further comprising: [Section 71] Using the information stored in the database to transmit the information to the patient's physician and / or the patient's electronic medical record. 70. The method of claim 69, further comprising: [Section 72] automatically modifying parameters of treatment or use of the device using the information stored in the database. 70. The method of claim 69, further comprising: [Explanation of symbols]

[0071] 1. First electrode of the electrode 2 wire 3. Magnets 4 pole pieces 5 Fixed Elements 6 nuts 7 Adapters 8 Second pole of the electrode 9. Sauce 10 Diamagnetic Wedge 11 Main magnet 12 Passive conductive contacts 13 Control Unit 14 Detector 15 electrodes 16 Controllers 17 Sensors 18 Generator 19 Amplifier 20 IR diodes 21 aperture 22 Converging Lens 23 IR filter 24 Preamplifier 25 Frequency Filters 26 Demodulator 27 Level Converter 28 Programmable Retarder 29 Exciter 30 First Piezo Element 31 feet 32 Second Piezo Element 33 Amplifier 34 Frequency Filter

Claims

1. 1. A neuromodulation device for the medical treatment of lower urinary tract dysfunction, comprising: a pulse generator configured to generate electrical pulses; a control unit configured to control the pulse generator and to set at least one parameter of the generated electrical pulses; at least one active electrode connected to the pulse generator, the at least one active electrode having a conductive surface configured to be attached to a patient's leg, the at least one active electrode adapted to stimulate nerves in the patient's leg via the conductive surface with the electrical pulses generated by the pulse generator; a response detector configured to detect a reflex movement of the stimulated leg in response to the neural stimulation and to provide feedback to the control unit regarding the detected reflex movement; and for the medical treatment, the control unit during a recognition phase, searching for ideal parameters of current for the patient as a stimulation setting until the detected reflex movement of the stimulated leg falls within a predetermined range of the reflex movement; During a treatment phase, maintaining the searched parameters as the stimulation settings for a predetermined stimulation time, provided that the detected reflex movement of the stimulated leg remains within the predetermined range of reflex movement. further configured as follows: A neuromodulation device characterized by:

2. 2. The neuromodulation device of claim 1, further comprising a ground electrode connected to the pulse generator and configured to be attached to the patient's skin, wherein the at least one active electrode comprises at least two active electrodes, each of the at least two active electrodes having the conductive surface adapted to stimulate a respective nerve of the patient with the electrical pulses generated by the pulse generator.

3. 3. The neuromodulation device of claim 2, wherein the at least two active electrodes comprise a first active electrode configured to be attached to a first leg of the patient and a second active electrode configured to be attached to a second leg of the patient.

4. The neuromodulation device of claim 1, characterized in that the pulse generator generates electrical pulses at a frequency comprised between 2.5 Hz and 60 Hz, and the electrical pulses have a pulse width comprised between 0.1 ms and 2.5 ms.

5. The neuromodulation device of claim 1, characterized in that the pulse generator generates electrical pulses at a frequency comprised between 1 Hz and 15 Hz, or the pulse generator generates electrical pulses at a frequency comprised between 2 Hz and 6 Hz.

6. The neuromodulation device of claim 1, characterized in that if, during the treatment phase, the detected reflex movement falls outside the predetermined range of the reflex movement, the control unit is further configured to return to and start the recognition phase to determine new stimulation settings.

7. The neuromodulation device of claim 6, characterized in that when the recognition phase is started again to determine new stimulation settings, the initial setting of at least one parameter of the generated electrical pulses is set to the previously determined setting.

8. 3. The neuromodulation device of claim 1 or 2, wherein the response detector comprises at least one of an electromyograph or an accelerometer sensor for sensing the reflex movement.

9. A neuromodulation device as described in claim 1 or 2, characterized in that the nerve to be stimulated is the peroneal nerve or the tibial nerve.

10. 10. The neuromodulation device of claim 9, wherein the at least one active electrode is configured to be attached to an expected location of a branch of the peroneal nerve or a branch of the tibial nerve behind the knee of the patient's leg.

11. 2. The neuromodulation device of claim 1, wherein the at least one parameter of the generated electrical pulse comprises frequency, pulse length, current, voltage, or a combination thereof.

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