Selective neuromodulation devices

Abstract

A neuromodulation device and a method of using the neuromodulation device. The neuromodulation device has a plurality of active electrodes, at least one reference electrode, a pulse generator, and a control unit. The plurality of active electrodes are electrically isolated from each other and arranged in at least one electrode array. The pulse generator is electrically connected to each of the plurality of active electrodes and configured to selectively transmit electrical pulses to each of the plurality of active electrodes. The control unit is coupled to the electrical pulse generator and adapted to measure the resistance and / or current-voltage characteristics between each of the plurality of active electrodes and the at least one reference electrode.

Description

Technical Field

[0001] This disclosure generally relates to a selective and effective neural modulation. More specifically, this disclosure relates to a neural modulation device that enables the accurate targeted transmission of neural modulation signals from a signal generator to a target nerve. Background Technology

[0002] This section provides background information relating to this disclosure that is not necessarily prior art.

[0003] Electroneuromodulation has been used to treat pain, urinary incontinence, mental disorders and other conditions, and to prevent vascular diseases.

[0004] Traditional systems utilize simple neuromodulation electrodes in the form of invasive needle-like electrodes inserted close to the nerve to be stimulated. The need to insert needle-like electrodes close to the nerve is always associated with the risk of improper electrode placement and the resulting nerve damage, or, when not placed close to the target nerve, lower than desired neuromodulation efficiency.

[0005] In recent years, novel non-invasive methods using electrodes made of metal have been developed to achieve desired neuromodulation. The appropriate tip of these electrodes is placed on a stimulation point on the patient's skin. The stimulation point is typically located close to the intended position based on experience and knowledge of human anatomy. The intensity of the neuromodulation pulse is usually preset by the manufacturer.

[0006] A drawback of this method is the lack of optimal neuromodulation locations for the electrodes, which has a significant impact on the overall neuromodulation therapy, as the therapeutic efficacy of neuromodulation is attributed to the selective activation of target tissues or neural circuits. Furthermore, the electrodes may shift during neuromodulation, further hindering the therapeutic effect.

[0007] Therefore, it would be advantageous to have equipment that takes into account at least some of the problems discussed above, as well as possibly others. Summary of the Invention

[0008] One object of this disclosure is to address at least some of these drawbacks. An aspect of this disclosure relates to a neuromodulation device. The neuromodulation device includes a plurality of active electrodes electrically isolated from each other and arranged in at least one electrode array. Each active electrode includes a conductive element suitable for or under the skin of a patient. The neuromodulation device further includes: at least one reference electrode suitable for or under the skin of a patient; a pulse generator electrically connected to each of the plurality of active electrodes and configured to selectively transmit electrical pulses to each of the plurality of active electrodes; and a control unit coupled to the electrical pulse generator and adapted to measure the resistance and / or current-voltage characteristics between each of the plurality of active electrodes and the at least one reference electrode. Based on the measured resistance and / or current-voltage characteristics, the control unit is adapted to control the shape of the electrical pulses and select which of the plurality of active electrodes(s) receives the electrical pulses generated by the pulse generator.

[0009] On the other hand, the control unit is configured to repeatably measure the resistance and / or current-voltage characteristics between each of the plurality of active electrodes and at least one reference electrode.

[0010] On the other hand, based on repeatable measurements, the control unit is further configured to update the selection of which active electrode(s) among a plurality of active electrodes to receive electrical pulses generated by the pulse generator.

[0011] In another aspect, the neuromodulation device further includes at least one detector configured to detect a patient's response to at least one pulse generated by a pulse generator. The detector is further adapted to provide feedback to a control unit regarding the detected response.

[0012] On the other hand, at least one detector is at least one motion detector, which is configured to detect the patient’s movement and is adapted to provide feedback on the movement to the control unit, wherein the movement of the patient’s body is in response to at least one pulse from the pulse generator.

[0013] On the other hand, at least one motion detector includes at least one of an accelerometer, an electric field sensor, or a camera.

[0014] On the other hand, the control unit is further adapted to individually select each of the plurality of active electrodes for receiving at least one pulse generated by the pulse generator, and the control unit is further adapted to receive a patient response detected by the detector to at least one pulse generated by the pulse generator for each of the plurality of active electrodes individually selected.

[0015] On the other hand, the control unit is adapted to control the shape of the electrical pulse and select which of a plurality of active electrodes to receive the electrical pulse generated by the pulse generator based on the measured resistance and / or current-voltage characteristics and the response detected by at least one detector.

[0016] On the other hand, the control unit is further configured to determine the current density of the electrical pulse flowing through each selected active electrode, and based on the result, selectively employ active electrodes adjacent to each selected active electrode in the same electrode array to receive electrical pulses generated by the pulse generator in the same way.

[0017] On the other hand, the control unit is configured to control the slope of the rising edge of the electrical pulse and / or the amplitude of the electrical pulse.

[0018] On the other hand, the control unit is further configured to control the pulse period and / or pulse width of the electrical pulse.

[0019] On the other hand, the neuromodulation device further includes a probe having a contact surface carrying an electrode array, the contact surface including protrusions having at least a portion of the active electrodes of the electrode array.

[0020] On the other hand, the electrode array extends around the protrusion on the contact surface.

[0021] On the other hand, the contact surface has a generally recessed shape with a protrusion in the first direction, wherein the contact surface has a generally convex shape in the second direction perpendicular to the first direction.

[0022] On the other hand, a method using a neuromodulation device is provided, comprising: applying a plurality of active electrodes arranged in at least one electrode array to the skin of a patient at a possible location of a target nerve to be stimulated or modulated, wherein the active electrodes are electrically isolated from each other; applying at least one reference electrode to the skin of the patient; measuring, by a control unit, the resistance and / or current-voltage characteristics between each of the plurality of active electrodes and the at least one reference electrode; selecting one or more of the plurality of active electrodes to receive electrical pulses generated by a pulse generator, the pulse generator being selectively electrically connected to each of the plurality of active electrodes; and controlling, by the control unit, the shape of the electrical pulses generated by the pulse generator based on the measured values.

[0023] In another aspect, the method includes repeatably measuring the resistance and / or current-voltage characteristics between each active electrode arranged in each of at least one electrode array and each of at least one reference electrode, and updating the measured values ​​with new measurements of each of at least one electrode array.

[0024] In another aspect, the method includes detecting the patient's body's response to at least one pulse generated by a pulse generator, and providing feedback to a control unit regarding the detected response.

[0025] In another aspect, the method includes applying at least one pulse generated by a pulse generator to each individual active electrode among a plurality of electrodes, and receiving a patient response detected by a detector for each active electrode among the plurality of electrodes.

[0026] On the other hand, the selection of the active electrode for receiving the electrical pulses generated by the pulse generator is also based on the patient response detected by the detector for each individual active electrode among the multiple electrodes.

[0027] On the other hand, the method includes determining the current density of an electrical pulse flowing through each selected active electrode, and selectively employing active electrodes adjacent to each selected active electrode in the same electrode array, based on the result, to receive electrical pulses generated by the pulse generator in the same manner.

[0028] On the other hand, it relates to a method of medical treatment using a neuromodulation device as defined above for at least one of the following: overactive bladder, migraine, erectile dysfunction, spermatogenesis disorder, infertility, premature ejaculation, or benign prostatic hyperplasia.

[0029] On the other hand, a method for medical treatment includes applying a plurality of active electrodes arranged in at least one electrode array to the skin of a patient, wherein the at least one electrode array is located in at least one of the following possible locations: sciatic nerve, perineal nerve, peroneal nerve, cavernous nerve, sacral plexus nerve, vagus nerve, or tibial nerve.

[0030] On the other hand, the method for medical treatment includes applying at least one electrode array to possible locations such as the lumbosacral plexus, common peroneal nerve, superior gluteal nerve, inferior gluteal nerve, posterior femoral cutaneous nerve, obturator internus nerve, piriformis nerve, quadratus femoris nerve, plantar nerve, vagus nerve, or coccygeal nerve.

[0031] On the other hand, a method for medical treatment includes applying a plurality of active electrodes arranged in at least one electrode array to the skin of a patient, wherein the at least one electrode array is located at a possible location of at least one of a nerve containing sensory nerve fibers and motor nerve fibers. The precise location of one or more of the active electrodes can be confirmed by a detected response of the patient to at least one electrical pulse generated by a pulse generator. The response may involve a motor response of the patient's leg, such as flexion of the toes or movement of the toes.

[0032] On the other hand, a method for medical treatment includes applying a plurality of active electrodes arranged in at least one electrode array to the skin of a patient, wherein the at least one electrode array is located at the location of the common peroneal nerve (behind the knee). The precise location of the active electrodes can be confirmed by a detected response of the patient to at least one electrical pulse generated by a pulse generator. The precise location of one or more active electrodes among the plurality of electrodes can be confirmed by a detected response of the patient to at least one electrical pulse generated by a pulse generator. The response may involve a motor response of the patient's leg, such as flexion of the toes or movement of the toes.

[0033] On the other hand, a method for medical treatment includes applying a plurality of active electrodes arranged in at least one electrode array to the skin of a patient, wherein the at least one electrode array is located at the position of the tibial nerve, which may be behind the knee or behind the medial malleolus. The precise location of one or more of the active electrodes can be confirmed by a detected response of the patient to at least one electrical pulse generated by a pulse generator. The response may involve a motor response of the patient's leg, such as flexion of the toes or movement of the toes.

[0034] On the other hand, methods used for medical treatment can be used in combination with, or as part of, methods using neuromodulation devices as defined above.

[0035] Other applicable scope will become apparent from the description herein. The description and specific examples in the summary of the invention are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0036] Other features and advantages of the invention will become apparent from the following detailed description of some embodiments given as non-limiting examples and with reference to the accompanying drawings, in which:

[0037] - Figure 1 This is a block diagram depicting an embodiment of a neural modulation device.

[0038] - Figure 2 This is a block diagram depicting an embodiment of the control unit.

[0039] - Figure 3 This is a block diagram depicting an embodiment of a pulse generator.

[0040] - Figure 4 This is a block diagram depicting another embodiment of a neural modulation device.

[0041] - Figure 5 This is an exemplary schematic diagram showing electrodes placed on a patient and a camera acting as a motion detector.

[0042] - Figure 6This is an exemplary schematic diagram showing electrodes placed on a patient and an accelerometer acting as a motion detector.

[0043] - Figure 7 This is an exemplary schematic diagram of electrodes positioned on a patient.

[0044] - Figure 8 This is another exemplary schematic diagram of electrodes placed on a patient.

[0045] - Figure 9 This is an exemplary perspective view of the reference electrode.

[0046] - Figure 10 This is an exemplary perspective view of an active electrode array.

[0047] - Figure 11 This is an exemplary perspective view of a probe with an electrode array.

[0048] - Figure 12 This is an exemplary schematic diagram of an electrical pulse variable.

[0049] - Figure 13 This is a flowchart depicting an embodiment of a method using a neuromodulation device.

[0050] - Figure 14 This is a flowchart depicting an embodiment of a method for determining the pulse shape. Detailed Implementation

[0051] The above overview and the following detailed description of certain examples will be better understood when read in conjunction with the accompanying drawings. As used herein, elements or steps described in the singular and following the words “a” or “an” should be understood to not exclude a plurality of such elements or steps, unless explicitly stated otherwise. Furthermore, references to “an embodiment” are not intended to be construed as excluding the existence of additional embodiments having the same feature. Moreover, unless explicitly stated otherwise, embodiments that “comprise” or “have” one or more elements having a particular property may include other elements that do not have that property.

[0052] In the figures, the same reference numerals denote the same or similar elements unless otherwise stated. In the figures, for ease of description and clarity, the size of each element or particular part constituting the elements is shown enlarged, omitted, or schematically. Therefore, the size of each component may not perfectly reflect its actual size. Such descriptions are omitted where it is determined that a detailed description of a related known function or construction might unnecessarily obscure the essence of this disclosure.

[0053] exist Figure 1The diagram depicts an exemplary embodiment of a neuromodulation device 1. The embodiment includes a plurality of active electrodes 2 arranged in an electrode array 3, a reference electrode 4, a pulse generator 3, and a control unit 4. The pulse generator 5 may be electrically connected to each of the plurality of active electrodes 2, and the pulse generator may also be electrically connected to the reference electrode. The neuromodulation device may have multiple electrode arrays and / or multiple reference electrodes.

[0054] The pulse generator 5 can selectively transmit electrical pulses individually to each of the plurality of active electrodes 2, or selectively transmit electrical pulses to several active electrodes among the plurality of active electrodes. The electrode array 3 can be adapted to the patient's skin. Each of the plurality of active electrodes 2 arranged in the electrode array can have a conductive element that can be adapted to the patient's skin and / or under the patient's skin. The reference electrode 4 can also be adapted to the patient's skin and / or under the patient's skin, and the reference electrode 4 can also contain a conductive element adapted to the patient's skin or under the patient's skin. Assuming that the plurality of active electrodes and the reference electrode are both applied to the patient's skin, the resistance 7 and / or current-voltage characteristics 8 between each of the plurality of active electrodes 2 and the reference electrode 4 can be measured.

[0055] like Figure 2 As depicted, an embodiment of the control unit 6 can be coupled to a pulse generator 5 and can measure the resistance 7 and / or current-voltage characteristic 8 between each of the plurality of active electrodes 2 and a reference electrode 4. The plurality of active electrodes can be arranged in one or more electrode arrays, and one or more reference electrodes may be present. In this case, the control unit can measure the resistance 7 and / or current-voltage characteristic 8 between each of the plurality of active electrodes 2 and at least one reference electrode 4. The control unit 6 may include a control module 10 and a measurement module 12. The measurement module 12 can perform the resistance measurement 7 and / or current-voltage characteristic measurement 8. The control module 10 and the measurement module 12 can be electrically connected such that the control module 10 can read and interpret the data provided by the measurement module 12. The control module 10 can control the measurements performed by the measurement module 12. The control module 10 of the control unit 6 can repeatably measure the resistance and / or current-voltage characteristics. The control module 10 of the control unit 6 can perform periodic or individual measurements of the resistance and / or current-voltage characteristics. The repeatable measurements performed by the control unit 6 can be used to update the selection of which active electrode(s) among the multiple active electrodes(s) 2 will receive the electrical pulses generated by the pulse generator 5.

[0056] The control unit 4 may further include a memory 9. For each individual active electrode among the plurality of active electrodes, the control unit may store resistance 7 and / or current-voltage characteristic measurement data in the memory 9. For each individual active electrode among the plurality of active electrodes, the control unit may read the stored resistance 7 and / or current-voltage characteristic measurement data from the memory 9. Based on the measured resistance and / or current-voltage characteristics, the control unit 6 may control the shape of the electrical pulses generated by the pulse generator 5 and / or select which active electrodes or active electrodes to receive the electrical pulses generated by the pulse generator 5. In one example, the control unit evaluates active electrodes arranged in the same electrode array based on its measured resistance and / or current-voltage characteristics. The control unit may then select the active electrode with the lowest resistance measurement value and / or current-voltage characteristic value for receiving the electrical pulse. One advantage of this example is that the lowest resistance measurement value and / or current-voltage characteristic value indicates the nerve closest to the patient. Since there may be more nerves close to each other, evaluating several individual active electrodes with the lowest measurements allows for the individual evaluation of the active electrode closest to the nerve, and the selection of the desired nerve for neuromodulation based on further evaluation.

[0057] The control unit 6 may employ the control module 10 to store and retrieve data from the memory 9. The control module 10 may store data measured by the measurement module 12 in the memory 9. The control module 12 may further process and / or interpret the measured data before storing it. The control module 10 may store and retrieve patient-related data into the memory 9, and may match patient data with measured data, and vice versa. The control module 10 may be further configured to store and retrieve setting data of the neuromodulation device 1 related to a specific patient into the memory 9. The setting data may be measured values ​​and / or generated pulse settings. The control module 10 may further match patient data with measured data, and vice versa. The control module 10 may further match the setting data of the neuromodulation device with patient data and measured data.

[0058] The neuromodulation device 1 may further include at least one detector 11 to detect a patient's response to at least one pulse generated by the pulse generator 5, as described in embodiments of the neuromodulation device 1. Figure 4 As shown. Figure 2At least one detector 11 can provide feedback to the control unit 6 regarding a detected response. At least one detector 11 can provide feedback to the control module 10 of the control unit 6. At least one detector can be at least one motion detector 21 configured to detect patient movement. At least one detector can be adapted to provide feedback to the control unit 6 regarding patient movement. Movement of the patient's body can be in response to at least one pulse from a pulse generator, which can be transmitted via a selected active electrode attached to or beneath the patient's skin. At least one motion detector 21 includes at least one of an accelerometer 22, an electric field sensor 23, or a camera 24. Alternatively, at least one detector 11 can be configured to detect changes in electrical activity generated by muscles as a response to at least one pulse generated by the pulse generator 5 and transmitted via a selected active electrode attached to or beneath the patient's skin. Such an electromyography (EMG) activity detector 19 can be an EMG-based detector 20.

[0059] Preferably, such as Figure 6 As depicted, when using accelerometer 22 as a motion detector, accelerometer 22 can then be attached to the foot of one of the patient's legs 26, 30. Advantageously, two accelerometers 22 can be used as two motion detectors, each attached to a different foot of the patient's legs 26, 30. Optionally, as Figure 5 As depicted, when camera 24 is used as motion detector 21, the camera can then be positioned near the detected motion and oriented to detect the motion. Optionally, electric field sensor 23 can be used as motion detector 21. Electric field sensor 23 can use changes in the electric field to detect patient movement. An example of such electric field sensor could be a three-dimensional pose recognition and tracking controller chip that uses the electric field to provide pose information and position data of the human limbs in real time. Advantageously, a combination of motion detectors selected from one or more of camera 24, accelerometer 22, and electric field sensor 23 can be used. This can result in improved accuracy of the sensed movement and also provides redundancy in detection.

[0060] The control unit 6 can also control the shape of the electrical pulses generated by the pulse generator 5 based on the measured resistance and / or current-voltage characteristics. For example... Figure 3The illustration depicts an embodiment of a pulse generator 5. The pulse generator 5 can be controlled by a control unit 6, or the pulse generator can be directly controlled. Preferably, the pulse generator 5 includes a pulse control module 13 connected to the control unit 6. The connection between the pulse control module 13 and the control unit 6 can be, for example, a wired connection via a cable or a wireless connection. Preferably, the pulse control module 13 is further connected to a plurality of electrodes 2 arranged in at least one electrode array 3. The connection between the pulse control module 13 and the plurality of electrodes 2 can be, for example, a wired connection via a cable or a wireless connection. The pulse control module 13 may include an edge slope control module 14 configured to control the slope of the edges of the pulses generated by the pulse generator. As illustrated in the exemplary pulse distribution 60... Figure 12 As depicted, the controlled edge can be the rising edge 64 and / or the falling edge of the pulse. The pulse control module 6 may further include a period control module 8 configured to control the period 63 of the generated pulse. The pulse control module 6 may further include a pulse width control module 9 configured to control the width 62 of the generated pulse. The pulse width control module 9 can perform pulse width modulation of the pulse. The pulse control module 6 may further include an amplitude control module 10 configured to control the amplitude 61 of the generated pulse.

[0061] Figure 5 and 6 Exemplary illustrations 28, 29 are provided showing at least one of an electrode array 3 having a plurality of active electrodes 2 placed on or under the skin 25 of a patient, wherein at least one of the electrode arrays 3 may be applicable to a limb 26 of the patient 25 and the detected movement of the patient may be a movement 27 of the limb. At least one of the electrode arrays 3 may be applicable to the ankle to the back of the knee of the limb 26, 30. A reference electrode 4 may be applicable to the abdomen of the patient 25. Alternatively, the reference electrode 4 may be applicable to other locations, such as the hip or lower back of the patient 25. The motion detector 21 may be a camera 24 or an electric field sensor 23. The motion detector may detect the movement 27 of the limb 26. The movement of the limb may be in response to transmitting at least one pulse from a pulse generator to at least one active electrode placed on or under the skin of the patient.

[0062] Figure 7An advantageous embodiment 31 of electrode array placement on the patient's legs 26 and 30 is depicted. Two electrode arrays 32, 33 may be applied to the back of the knee of the patient 25. A first electrode array 32 may be applied to the back of the knee of the first leg 26 of the patient 25, and a second electrode array 33 may be applied to the back of the knee of the second leg 30 of the patient 25. Alternatively, the first electrode array 32 may be applied to the first leg 26, near the ankle of the first leg 26 of the patient 25. The second electrode array 33 may be applied to the second leg 30 of the patient 25, near the ankle of the second leg 30 of the patient 25. Each of the legs 26, 30 may be attached to a motion detector 21, which may be an accelerometer 22. Each of the accelerometers 22 may be attached to the foot of one of the legs 26, 30. Preferably, each of the accelerometers 22 may be attached to its corresponding foot in the toe region.

[0063] Figure 8 Another alternative placement of the electrode array is depicted, wherein at least one of the electrode arrays 3 may be applied to the throat 35 or face 34 of the patient 25, and the detected movement of the patient may be a movement of at least one facial muscle of the patient 25. The movement may be detected by a camera 24 as depicted or by an electric field sensor 23 used as a motion detector. At least one reference electrode 4, not shown, may also be applied to the head, jaw, or throat.

[0064] An exemplary embodiment of the reference electrode 39 has a conductive element 36 suitable for a patient's skin. Preferably, the reference electrode further includes a non-conductive material 37 to which the conductive element 36 is coupled. The conductive element 36 may also be embedded in the non-conductive material. The non-conductive material may have any suitable shape for placing the reference electrode on or under the patient's skin. The non-conductive material 37 may provide a support and / or retention member for the conductive element 37 of the reference electrode 4. Preferably, the reference electrode 4 further has a wire or cable 38 suitable for electrically connecting the conductive element 36 of the reference electrode to the pulse generator 5 and / or the control unit 6.

[0065] Figure 10 An exemplary embodiment of an electrode array 40 having a plurality of active electrodes 2 is depicted. The plurality of active electrodes may be formed by a plurality of conductive elements 41 electrically isolated from each other. Each of the conductive elements 41 in the electrode array 40 may be configured as follows: Figures 5 to 8The electrode array 40 is exemplarily shown in the diagram as a placement on the skin of the patient 25 to achieve placement of the electrode array on the patient 25's body. The shape of the electrode array 40 may include a truncated conical shape, an elliptical shape, a curved shape, or a flat shape. Conductive elements 41 may be placed near each other. Non-conductive material 42 may provide support and / or holding members for the conductive elements, thereby ensuring that the conductive elements 41 are held in place and electrically isolated from each other. Preferably, each of the conductive elements 41 includes a wire or cable 43 suitable for electrically connecting the conductive element 41 to the pulse generator 5 and / or the control unit 6.

[0066] The neuromodulation device may further include probe 50. Figure 11 An exemplary embodiment of the probe 50 is depicted. The probe 50 may have a contact surface 51 that carries an electrode array 53 having a plurality of active electrodes 2. Each of the active electrodes 2 has a conductive element 54. The active electrodes 2 may be partially embedded within the probe 50, with the corresponding conductive element 54 of the active electrodes protruding outward from the contact surface 51 of the probe. The contact surface 51 of the probe 50 may include a protrusion 52 having at least a portion of the active electrodes of the electrode array 53. The electrode array 53 may extend around the protrusion on the contact surface 51. The contact surface 51 has a generally recessed shape in a first direction X from which the protrusion 52 protrudes. The contact surface may have a generally convex shape in a second direction Y perpendicular to the first direction X. One advantage of having a probe is that the conductive elements of the active electrodes can be advantageously positioned on the patient's skin, thus being more effective in delivering electrical impulses to the target nerve. The probe may further have at least one notch 56, thereby enabling attachment of the probe to the patient's skin.

[0067] refer to Figure 13 An exemplary flowchart illustrates 70 of a neuromodulation method using a neuromodulation device. Method 70 may include step 71 of applying at least one electrode array 3, in which a plurality of active electrodes 2 are arranged, to the skin of a patient. The at least one electrode array 3 may be positioned at a possible location of a target nerve to be modulated. Possible locations of the target nerve may be behind the knee or ankle, the throat, or any other suitable location for neuromodulation near the target nerve. The target nerve for neuromodulation may be at least one of the following: sciatic nerve, perineal nerve, peroneal nerve, cavernous nerve, sacral plexus, tibial nerve, lumbosacral plexus, common peroneal nerve, superior gluteal nerve, inferior gluteal nerve, posterior femoral cutaneous nerve, obturator internus nerve, piriformis nerve, quadratus femoris nerve, plantar nerve, vagus nerve, or coccygeal nerve.

[0068] In step 72, at least one reference electrode 4 may be attached to the patient's skin. At least one reference electrode 4 may be attached to the abdomen of the patient 25, or the buttocks, waist, or ankle of the patient 25, or other locations.

[0069] In step 73, resistance measurements and / or current-voltage characteristics may be performed between each active electrode in at least one electrode array 3 and at least one reference electrode 4.

[0070] In step 74, one or more active electrodes among a plurality of active electrodes 2 within at least one electrode array 3 may be selected based on the measured value to receive electrical pulses generated by a pulse generator selectively electrically connected to each of the plurality of active electrodes.

[0071] In step 75, the electrical pulse can be generated by a pulse generator, and its shape can be controlled by a control unit based on measured values ​​of resistance and / or current and voltage characteristics.

[0072] Method 70 may further include a step of repeatably measuring the resistance and / or current-voltage characteristics between each active electrode in at least one electrode array 3 and at least one reference electrode 4. Based on the measurement results, the selection of which active electrode(s) in the electrode array will receive the electrical pulse generated by the pulse generator can be updated.

[0073] Method 70 may further include the steps of: detecting the patient’s body’s response to at least one pulse generated by the pulse generator, and providing feedback to the control unit about the detected response.

[0074] One advantage of the above method is that, based on the measurement results, it is possible to determine which active electrodes within the electrode array will receive the electrical pulses generated by the pulse generator, as well as the shape of the pulses, such as their amplitude 61, pulse width 62, pulse period 63, and / or rising / falling edges. Therefore, this method allows for the individual setting of the optimal shape of the pulses generated by the pulse generator for each patient, and the identification of the active electrodes within the electrode array that are closest to the target nerve.

[0075] Another benefit of the above method is that measuring the resistance or current-voltage characteristics between each of the active electrodes and the reference electrode can provide verification that the active and reference electrodes are properly attached to the patient's skin. In the event that either active electrode of the reference electrode is not properly attached to the patient's skin, the resistance measurement between the electrode and the other electrode will indicate this in the measured value.

[0076] Another benefit is that measurements of the resistance or current-voltage characteristics between each of the active electrodes and the reference electrode can be used for self-testing of the operation of the neuromodulation device 1. This self-testing can be achieved by performing multiple subsequent measurements and comparing their results. For this purpose, periodic measurements of the resistance or current-voltage characteristics can be performed. Alternatively, a single non-periodic measurement of the resistance or current-voltage characteristics can be performed during the operation of the neuromodulation device 1 and used for self-testing. For example, an initial measurement can be performed at discrete intervals, followed by a non-periodic or ad hoc measurement. Periodic, non-periodic, or ad hoc measurements of the resistance or current-voltage characteristics can be combined to achieve automatic self-testing of the neuromodulation device 1. This technical self-testing provides verification of the neuromodulation device's functionality during use, thus ensuring the safety and efficiency of targeted neuromodulation or stimulation due to repeated measurements of the resistance or current-voltage characteristics.

[0077] exist Figure 14 The exemplary flowchart illustrates another embodiment 80 of the neural modulation method. Method 80 can be combined with... Figure 13 Method 70 is used, or as Figure 13 Method 70 is used as a part of the method. Method 80 may include step 81 of applying at least one electrode array 3 having a plurality of active electrodes 2 to the patient's skin at a possible location of the target nerve to be modulated or stimulated. Possible locations of the target nerve may be the back of the knee, ankle, throat, or any other suitable location for nerve modulation near the target nerve for nerve modulation. The target nerve for nerve modulation may be at least one of the following: sciatic nerve, perineal nerve, peroneal nerve, cavernous nerve, sacral plexus, tibial nerve, lumbosacral plexus, common peroneal nerve, superior gluteal nerve, inferior gluteal nerve, posterior femoral cutaneous nerve, obturator internus muscle nerve, piriformis muscle nerve, quadratus femoris muscle nerve, vagus nerve, plantar nerve, or coccygeal nerve.

[0078] In step 82, at least one reference electrode 4 may be attached to or under the skin of the patient 25. At least one reference electrode 4 may be attached to the abdomen of the patient 25, or the buttocks or waist of the patient 25, or other locations.

[0079] In step 83, an initial measurement of resistance or current-voltage characteristics may be performed between each active electrode in at least one electrode array 3 and at least one reference electrode 4.

[0080] In step 84, at least one pulse generated by the pulse generator is applied to each individual active electrode among a plurality of electrodes within at least one electrode array 3, and the patient's response is detected by a detector for each active electrode among the plurality of electrodes. At least one pulse can be sequentially applied to each individual active electrode among the plurality of active electrodes 2. One advantage of sequentially applying pulses to each active electrode among the plurality of electrodes is that the patient's response level can be used for initial calibration of the neuromodulation device for a specific patient.

[0081] In step 85, one or more active electrodes are selected to receive additional electrical pulses based on resistance and / or current and voltage measurements and / or by the patient response detected by the detector for each individual active electrode in the plurality of electrodes 2 within at least one electrode array 3.

[0082] Method 80 may further include a step of repeatably measuring the resistance and / or current-voltage characteristics between each active electrode in at least one electrode array 3 and at least one reference electrode 4. Based on the measurement results, the selection of which active electrode(s) in the electrode array will receive the electrical pulse generated by the pulse generator can be updated.

[0083] Method 80 may further include the step of determining the current density of the electrical pulse flowing through each of the selected active electrodes 2. Based on the result of the current density, the method may also select additional active electrodes adjacent to each of the selected active electrodes in the same electrode array to also receive electrical pulses generated by the pulse generator. One benefit may be preventing excessive current density of electrical pulses flowing through each of the selected active electrodes applied to or under the patient's skin.

[0084] One benefit of method 80 is that the combination of resistance measurements and / or current-voltage characteristics with detector response enables the active electrode to be positioned in the most effective location for effective modulation of the target nerve.

[0085] While various spatial and directional terms such as top, bottom, lower, middle, lateral, horizontal, vertical, and front may be used to describe embodiments of this disclosure, it should be understood that such terms are used only with respect to the orientation shown in the accompanying drawings. The orientation may be reversed, rotated, or otherwise changed such that an upper portion becomes a lower portion, and vice versa, a horizontal portion becomes a vertical portion, and so on.

[0086] It should be understood that the above description is intended to be illustrative and non-limiting. For example, the embodiments (and / or aspects thereof) described above can be used in combination with each other. Furthermore, many modifications can be made to adapt particular situations or materials to the technical teachings of various embodiments of this disclosure without departing from its scope. While the dimensions and types of materials described herein are intended to define parameters of various embodiments of this disclosure, the embodiments are by no means limiting and are exemplary embodiments. Many other embodiments will become apparent to those skilled in the art upon review of the above description. Therefore, the scope of the various embodiments of this disclosure should be determined by reference to the appended claims and the full scope of their equivalents. In the appended claims, the terms “including” and “in which” are used as simple English equivalents to the corresponding terms “comprising” and “wherein”. Furthermore, the terms “first,” “second,” and “third,” etc., are used merely as labels and are not intended to impose numerical requirements on their objects. Furthermore, the limitations of the appended claims are not written in the device plus function format and are not intended to be interpreted based on 35 U.SC §112(f), unless and until such claims are explicitly limited by the phrase “device for…” followed by a functional statement without any other structure.

[0087] This written description discloses various embodiments of the present disclosure, including the best mode, by way of example, and also enables those skilled in the art to practice the various embodiments of the present disclosure, including making and using any apparatus or system and performing any incorporated methods. The patentable scope of the various embodiments of the present disclosure is defined by the claims, and may include other examples that may occur to those skilled in the art. Such other examples are contemplated within the scope of the claims if they have structural elements that are not different from the literal language of the claims, or if they contain equivalent structural elements that are not substantially different from the literal language of the claims.

Claims

1. A neural modulation device (1), comprising: Multiple active electrodes (2) are electrically isolated from each other and arranged in at least one electrode array (3), wherein each active electrode includes a conductive element (36, 41) configured to be adapted to the skin of a patient (25); At least one reference electrode (4), said at least one reference electrode being configured to fit the patient’s skin; A pulse generator (5) is electrically connected to each of the plurality of active electrodes and is configured to selectively transmit electrical pulses to each of the plurality of active electrodes. A control unit (6), coupled to an electrical pulse generator, is adapted to measure the resistance (7) and / or current-voltage characteristics (8) between each of the plurality of active electrodes and the at least one reference electrode, wherein, based on the measured resistance and / or current-voltage characteristics, the control unit is adapted to control the shape of the electrical pulse and select which of the plurality of active electrodes(s) will receive the electrical pulse generated by the pulse generator. The control unit is further configured to determine the current density of the electrical pulse flowing through each selected active electrode, and based on the result, selectively employ an active electrode adjacent to each selected active electrode in the same electrode array to receive the electrical pulse generated by the pulse generator.

2. The neural modulation device according to claim 1, characterized in that, The control unit is configured to repeatedly measure the resistance and / or current-voltage characteristics between each of the plurality of active electrodes and the at least one reference electrode.

3. The neural modulation device according to claim 2, characterized in that, Based on repeatable measurements, the control unit is further configured to update the selection of which of the plurality of active electrodes to receive the electrical pulses generated by the pulse generator.

4. The neuromodulation device of claim 1, further comprising at least one detector (11) configured to detect the patient’s response to at least one pulse generated by the pulse generator, wherein the detector is further adapted to provide feedback to the control unit regarding the detected response.

5. The neural modulation device according to claim 4, characterized in that, The at least one detector is at least one motion detector (21), which is configured to detect the patient’s movement and is adapted to provide feedback on the movement to the control unit, wherein the movement of the patient’s body is in response to at least one pulse from the pulse generator.

6. The neural modulation device according to claim 5, characterized in that, The at least one motion detector includes at least one of an accelerometer (22), an electric field sensor (23), or a camera (24).

7. The neural modulation device according to claim 4, characterized in that, The control unit is further adapted to individually select each of the plurality of active electrodes for receiving at least one pulse generated by the pulse generator, and the control unit is further adapted to receive a patient response detected by a detector to at least one pulse generated by the pulse generator for each individually selected active electrode of the plurality of electrodes.

8. The neural modulation device according to claim 7, characterized in that, The control unit is adapted to control the shape of the electrical pulse and select which of the plurality of active electrodes to receive the electrical pulse generated by the pulse generator based on the measured resistance and / or current-voltage characteristics and the response detected by the at least one detector.

9. The neural modulation device according to claim 1, characterized in that, The control unit is configured to control the slope of the rising edge (64) of the electrical pulse and / or the amplitude (61) of the electrical pulse.

10. The neural modulation device according to claim 1, characterized in that, The control unit is further configured to control the pulse period (63) and / or pulse width (62) of the electrical pulse.

11. The neuromodulation device of claim 1, further comprising a probe (50) having a contact surface (51) for carrying the electrode array, the contact surface including a protrusion (52) having at least a portion of an active electrode of the electrode array.

12. The neural modulation device according to claim 11, characterized in that, The electrode array extends around the protrusion on the contact surface.

13. The neural modulation device according to claim 11, characterized in that, The contact surface has a generally recessed shape in a first direction (X) from which a protrusion protrudes, wherein the contact surface has a generally convex shape in a second direction (Y) perpendicular to the first direction.

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