Implantable neural regulator device and system including same

Abstract

The present invention relates to an implantable neuroregulator device comprising a hermetically sealed housing, in which an antenna for communicating with an external device and / or for wirelessly receiving electrical energy is positioned within the housing, in which a main part of the housing is electromagnetically transparent to radiation in a frequency range below 20 MHz, in particular between 5 MHz and 15 MHz.

Description

Technical Field

[0001] The present invention relates to an implantable nerve regulator device and a system including the implantable nerve regulator device. Background Art

[0002] It is known from the prior art to use implantable devices to stimulate muscles for externally triggered muscle contractions, particularly in pacemaker devices such as cardiac pacemakers or other pacemakers. For those applications, implantable devices including energy storage devices, as well as corresponding electronics for energy management and also for generating and outputting electrical trigger pulses to an output port, which in turn is connected to an electrode lead, are known. The prior art has taught pacemaker devices that can be wirelessly recharged with electrical energy. Also, it is known from the prior art of pacemakers to transmit control data, particularly control parameters, via a wireless connection.

[0003] The field of nerve regulator devices includes different types of implantable devices. Implantable nerve regulator devices are used to provide stimulation to nerves, particularly via electrical pulses, for example in the pelvic region. Thus, implantable nerve regulator devices do not directly cause a physical response in the patient's body, such as muscle contraction. However, in the newer medical field of neuromodulation, it has been found that many pathological physical conditions of the patient's body can be alleviated or even cured through the regulation of nerves by new implantable regulator devices. These conditions include, but are not limited to, the treatment of erectile dysfunction, fecal incontinence, pressure sores, and paraplegia. There is also strong evidence that mental indications such as depression can be treated and / or cured through the neuromodulation of nerves.

[0004] Even though muscle stimulation by a pacemaker and the regulation of nerves are based on the same principle of providing electrical pulses by preferably implanted devices, the different applications and the resulting technical and medical requirements are significantly different between the field of muscle stimulation and the field of neuromodulation.

[0005] Previously, the implantation of nerve regulator devices has generally been limited by two basic constraints. First, the surgical methods and procedures for implanting nerve regulator devices into the body are quite complex and require very high skills of the corresponding surgeon. Additionally, nerve regulator devices known from the prior art are quite uncomfortable for the user, particularly due to the size of the nerve regulator device. When the nerve regulator device is implanted in certain parts of the user's body, the user can feel or perceive the implant during body movement or even when not moving if the implant exceeds a certain volume or size. This is at least uncomfortable for the user / patient and may cause pain and / or infection. Summary of the Invention

[0006] Based on this prior art, the object of the present invention is to provide an implantable neurostimulator device and a system comprising such an implantable neurostimulator device, which allows for easy implantation or is particularly suitable for simple implantation surgeries, and is more comfortable for the user after implantation.

[0007] These problems are solved by the implantable neurostimulator device according to claim 1 and the neurostimulator system according to independent claim 34. Preferred embodiments of the claimed invention are provided by the dependent claims, the following description, in particular the drawings, the description of the drawings, and the general description.

[0008] All aspects or features disclosed or described hereinafter as device features should also be considered as disclosed as part of the corresponding method and can also be claimed as a method, and vice versa.

[0009] The implantable neurostimulator device according to the present invention comprises an airtight housing, wherein an antenna for communicating with an external device and / or for wirelessly receiving electrical energy is located within the housing, and wherein a main part of the housing is electromagnetic transparent to radiation in a frequency range below 20 MHz, in particular between 5 MHz and 15 MHz.

[0010] In order to reduce the number of surgeries for long-term or extended use of an implantable neurostimulator device, it is important to be able to recharge the electrical energy storage device wirelessly and / or to be able to adapt the use of the neurostimulator device to the patient's needs wirelessly, i.e., without additional surgeries.

[0011] Although there are known devices capable of electromagnetic communication and / or electromagnetic energy transfer, these prior devices have a housing that generally consists of at least two main parts, one of the at least two main parts being electromagnetic transparent and the other being electromagnetic opaque. This known arrangement has two main drawbacks. First, the housing becomes rather bulky and takes up space. Second, the known arrangement only enables or provides a rather small antenna, i.e., an antenna with a relatively small receiving cross-section. Therefore, on the one hand, the relative alignment between the implant and the antenna and the device or part of the infrastructure for electromagnetic communication and / or electromagnetic energy transfer must be very precise. This is a challenge because every living organism exhibits continuous internal movement, which can affect the position of the implant on a small scale. In addition, the external body device for communication and / or energy transfer needs to be positioned very precisely and statically, which is also very demanding when the moving organism of the user is positioned very close. The first drawback of the large or space-consuming housing also has a direct impact on the surgery aimed at implanting the known device. The larger the implantable device, the more complex the surgery for implanting the neurostimulator device and fixing it in the body becomes. Additionally, the larger the implant device, the more adversely the quality of life of the patient is affected.

[0012] The present invention has surprisingly recognized that a housing made almost entirely of materials that are electromagnetically transparent to radiation in the frequency range below 20 MHz enables a very compact arrangement of an implantable nerve regulator device without compromising other important aspects of the device, such as biocompatibility, stability, etc. This allows for an easier implantation surgery and also greatly reduces the amount of resources, especially implantable ones, and thus the amount of biocompatible materials or resources, which makes the implantable nerve regulator according to the present invention not only much smaller, especially with less space occupancy, but also enables the use of a much larger antenna, especially an antenna with a much larger receiving cross-section.

[0013] A preferred embodiment of the present invention requires that at least 70% of the surface of the housing to be fabricated is electromagnetically transparent. Materials that are considered electromagnetically transparent in the said frequency range are ceramic materials, plastic materials, glass, resins, or combinations thereof.

[0014] Those materials known for biocompatibility in the field of implants are preferred materials that can exhibit the required transparency to electromagnetic radiation below 20 MHz.

[0015] According to a preferred embodiment, the housing has a circular cross-section, preferably having a tubular or cylindrical shape, and includes a first housing part and a second housing part, wherein the first housing part includes a container having a circular cross-section, the container being closed at one end and preferably rounded, and having a first sealing ring at the opposite or second end. The circular cross-section of the housing reduces the length of the incision required during the surgical implantation of the device, especially if the device can be implanted substantially by movement along a longitudinal axis extending substantially perpendicular to the circular cross-section. The preferably rounded end of the first housing part enables easy introduction into and advancement within the body during implantation. The preferred sealing ring enables and facilitates the connection between the first housing part and the second housing part to form a hermetically sealed housing.

[0016] The container of the first housing part is preferably shaped and sized such that, in the sealed state of the housing, the container and / or the first housing part will occupy or enclose most of the internal parts and components of the nerve regulator device. Thus, the first housing part can provide most of the volume of the nerve regulator device, while the second housing part has more of a shape and serves as a cap or cover.

[0017] In another preferred embodiment, the container, preferably together with the closed and preferably rounded end, is machined, especially turned, from a single-piece material (especially a ceramic material). This allows for the largest part (with respect to surface and enclosed volume) of the housing to be provided by a single piece of material without the need for joints and / or seals.

[0018] Although it is not easy to provide an integral piece of this ceramic material, it has surprisingly been proven that the advantages achieved through electromagnetic transparency and the absence of joints and connections or seals (which are potential sources of damage to the hermetic seal of the housing) outweigh the requirements for providing an integral piece of this ceramic material.

[0019] The machining of the container can be limited to a specific part or area of the volume, or the surface of the container. In particular, the surfaces that are crucial for the hermetic seal of the housing can be machined to achieve the necessary precision. For other parts of the container, machining may not be necessary because the required precision may be lower and / or the corresponding surface shaping can also be processed by other shaping methods and procedures, such as molding, extrusion, additive manufacturing, etc.

[0020] According to another preferred embodiment, the second housing part includes a second sealing ring and a feedthrough element, and the feedthrough element includes at least one opening in which an electrical contact element can electrically connect one side of the feedthrough element to a second side of the feedthrough element.

[0021] The second sealing ring is preferably provided with the same cross-section as the first sealing ring, especially the same outer cross-section, such that when the first sealing ring and the second sealing ring are joined to provide a hermetically sealed housing, there is a flush or continuous outer surface above the first sealing ring and the second sealing ring, especially apart from the seal itself.

[0022] The feedthrough element is preferably provided as another integral piece of material, especially a ceramic material, which not only adds to the electromagnetic transparent surface of the housing but also serves as a good electrical isolator for DC current and AC current, which is necessary for such a feedthrough element. Therefore, the feedthrough element can also include different insulator materials or can be made of different insulator materials, such as glass, resin, plastic, etc. The feedthrough element preferably has a disc shape or a spherical, spheroidal, bean-shaped, or lens-shaped form. In a preferred embodiment, the feedthrough element can be completely arranged in the inner opening of the second sealing ring such that in the longitudinal direction, the second sealing ring or a distal end portion of the second sealing ring forms an end portion of the housing.

[0023] According to another preferred embodiment, the feedthrough element can include at least four openings preferably arranged at two different height levels, where the height levels are defined by lines perpendicular to a diameter line passing through the center of the feedthrough element.

[0024] The embodiment with at least four openings in the feedthrough element allows for corresponding connections to electrode leads having at least four electrodes. In the case where the openings are arranged at different height levels, it is possible to contact the electrical contact elements extending through the openings on different sides of the support member or carrier, such as a PCB (printed circuit board) on different sides or different surfaces of the carrier, thus allowing for a very dense arrangement of the electrical contact elements.

[0025] In another preferred embodiment, two openings having a smaller distance between them along the height level are placed at a height level closer to the center of the feedthrough element than the opening having a larger distance between them along the height level.

[0026] In another preferred example, the contact element is electrically connected to the electrode lead for outputting an adjustment pulse to the patient. The connection between the contact element (which may be implemented as a copper pin) and the electrode lead can be achieved by a solder connection. Thus, the connection can be established mainly as an electrical connection. However, a connection such as a solder connection can also substantially increase the mechanical connection of the part, thereby providing basic mechanical strength.

[0027] In any case, for both AC and DC, the electrical contact elements passing through the feedthrough element are electrically isolated from each other.

[0028] In another preferred embodiment, the electrode lead of the device is mechanically connected to the device in a permanent or inseparable manner. This preferably includes the electrode lead up to the point where an electrical pulse is output to the body / patient. In other words, the device also includes a complete electrode lead that is inseparably connected. The mechanical connection can be achieved together with the electrical connection, i.e., through the contact element. However, it may be advantageous if the mechanical connection between the housing and the electrode lead is alternatively or additionally strengthened by a further mechanical connection, as will be discussed in more detail below. It has surprisingly been found that even with an inseparably connected electrode lead, the nerve regulator device of the present invention can be easily implanted into the body of a patient or a user.

[0029] In a further preferred embodiment, the first sealing ring and / or the second sealing ring is made of a metallic material, in particular titanium and / or surgical steel. These materials are well established in the field of implants and also allow a reliable high-quality connection or seal between the first sealing ring and the second sealing ring, preferably by a gold brazing connection.

[0030] According to another preferred embodiment, the first housing part and the second housing part are sealed to each other by a seal (preferably a gold brazing) connecting the first sealing ring and the second sealing ring. In another preferred embodiment, only three types of seals or connections must be established to form an airtight sealed housing or to seal the housing airtight. The first type of connection is the connection or seal between the sealing ring and the container of the first housing part, and the seal between the feedthrough element and the sealing ring of the second housing part. The second type of seal is the seal of the opening of the feedthrough element that holds the electrical contact element externally or radially outward. The third type of seal or connection is the connection between the first sealing ring and the second sealing ring.

[0031] The first and last types of connections may require sealing the ceramic material with a metallic material, which can be achieved by gold brazing. The second type of connection or seal, i.e., the connection between the sealing rings, can also be achieved by gold brazing. Thus, the entire sealing process of the housing can be achieved by forming a gold braze between the corresponding parts to hermetically seal the housing. This reduces the methods used in the production of the device and the materials used and introduced into the patient's body.

[0032] In an alternative advantageous embodiment, other types of connections may also be used. Alternatively, some connections may not be necessary at all, for example, if the feedthrough element is made of a molded resin or plastic element that is molded into the second sealing ring and the contact element is embedded therein. In this and similar embodiments, no additional connection between the corresponding parts is required.

[0033] In another preferred embodiment, the neuromodulator device includes an overmold that includes a molded head preferably made of a biocompatible polymer resin, the molded head covering at least a portion of the electrical contact element and the corresponding opening in the feedthrough element on one side of the feedthrough element, particularly on the outer side of the feedthrough element.

[0034] The molded head can be used to allow a reliable connection or reliable transmission between the housing of the neuromodulator on one side and the electrode lead on the other side. It can also be part of the connection between the device and its permanently connected electrode lead. It can also be used to improve the hermetic seal of the housing by further protecting the space between the feedthrough element and the opening in the electrical contact element.

[0035] According to a preferred embodiment, the overmold can include at least one opening and / or at least one suture hole for autologous fixation of the device and / or suturing the device to tissue material or bone material. The molded head is a preferred location for implementing the suture hole because the suture hole can be formed together with the molded head, particularly molded together with the molded head, without the risk that the seal of the housing may be compromised by the suture hole. Other advantageous arrangements of the opening or suture hole are possible.

[0036] In another preferred embodiment, the neuromodulator device can include a overmold, preferably made of a biocompatible polymer resin, covering the entire first and second housing portions and preferably forming a molded head and / or fixation wings. In those embodiments, the overmold covering the entire housing results in only a single material of the neuromodulator device contacting the interior of the body after implantation. Additionally, the overmold can compensate for manufacturing tolerances of the housing (which exist to some degree in each manufacturing or assembly process), enabling a highly reproducible and consistent final exterior for the neuromodulator device. The overmold can provide the molded head as well as the fixation wings, which will be described in more detail below.

[0037] The overmold can not only reduce the amount of material contacting the body after implantation, but also enable several functions, such as a molded head, suture holes, in a single manufacturing or assembly process via a single molding process, such as an injection molding process.

[0038] Another preferred embodiment requires the fixation wings to be formed at the ends of the housing, preferably adjacent to the first housing portion and / or at the opposite end of the overmold forming the molded head. Although the fixation wings at one end adjacent to the housing portion increase the overall length of the neuromodulator device, it can be preferable to suture holes within or implemented by the molded head because the suture mesh wings allow the surgeon more flexibility in suturing compared to suture holes included in the molded head.

[0039] The fixation wings can have a structured surface on two opposing surfaces. The structure can include openings / holes connecting the two surfaces. The structure can have a regular and / or repeating pattern. The structure can allow tissue growth through or into it and can assist in the autologous fixation of the device. The holes or openings can form a mesh and can be used as suture holes. Alternatively, the suture material can only pierce the material of the structured surface of the fixation wings forming the suture holes when suturing the device to tissue or bone.

[0040] According to another preferred embodiment, the fixation wings are formed in a plane parallel to the longitudinal axis of the housing. In another preferred embodiment, the fixation wings are formed at the center or center plane of the circular cross-section of the housing. This minimizes the resistance or drag of the device during surgical insertion, especially if the device is implanted or moved along its longitudinal axis.

[0041] The circular cross-section of the device has several advantages. However, this is also accompanied by the risk of undesired movement of the device after implantation. The movement can be translation along the longitudinal axis of the device and / or rotation about the longitudinal axis. The possible movement and effectively preventing such movement are crucial because the absolute and relative positions of the device have a significant impact on the efficiency of data and energy transmission from outside the body. Therefore, it has been proven advantageous that the fixing wings are very effective in eliminating such movements after implantation.

[0042] In a further preferred embodiment, the orientation of the fixing wings and / or the guiding member / electrode lead is aligned with and / or in a fixed position / orientation relative to other components of the device, such as the electrode lead and / or the antenna. This is very useful for the surgeon and allows for a very effective implantation of the implantable neurostimulator device. The surgeon can monitor the position and / or orientation of the fixing wings and / or the electrode lead and / or the guiding member (see below) during implantation, especially by imaging procedures such as endoscopy, ultrasound imaging, etc. This also includes fixing the device to the body (tissue or bone) by suturing, especially using the fixing wings as suture wings. Thereby, the absolute position and orientation of the device in the body are controlled, allowing for a controlled orientation of the internal part of the device.

[0043] As discussed in more detail below, it is particularly advantageous if the exterior of the device, such as the fixing wings, the electrode lead, the guiding member, etc., has a special, preferably parallel arrangement relative to the internal part of the device, especially the antenna and its receiving cross-section. Since the interior of the device is not visible, it is very helpful to be able to position and orient the internal structure of the device to a desired or advantageous position by positioning and orienting the exterior of the device.

[0044] A further preferred embodiment includes an overmolded part and / or an end part of the molded head opposite the housing or the second housing part, which includes a guiding member for guiding the electrode lead, wherein the guiding member is formed at an angle relative to the longitudinal axis of the housing, preferably 30° to 70°. The angled guiding member allows the electrode lead to be guided in a direction at an angle to the longitudinal axis of the housing, which makes it easier to position the electrode lead in the body during the implantation procedure. The guiding member can also adapt the orientation of the electrode lead to the anatomy of the body in which the device is implanted based on the position and / or orientation of the device being positioned and / or fixed to the body.

[0045] In a further preferred embodiment, the guiding member is formed in such a way that the electrode leads are guided in a plane parallel or identical to the plane of the fixing wing. After the electrode leads leave the guiding member, their orientation is of course flexible, being limited only by the flexibility of the electrode leads themselves. However, within the guiding member, the electrode leads are guided parallel to the fixing wing, which allows the overall basic orientation of the electrode leads away from the housing / and / or overmolding to be determined by controlling and fixing the position and / or orientation of the fixing wing.

[0046] The guiding member can be integrally formed with the molding head and / or the rest of the overmolding.

[0047] In another preferred embodiment, the ratio of the maximum diameter of the housing to the length of the housing (preferably including the molding head and / or overmolding) is less than 0.35. Such a relatively long implantable neuroregulator device, especially when combined with a circular cross-section, enables a surgical procedure with a very small incision and is easy to implant into the body and navigate within the patient's body.

[0048] In a preferred embodiment, the maximum diameter of the housing is less than 12 mm, preferably less than 10 mm. In another preferred embodiment, the maximum diameter of the overmolding is less than 13 mm, preferably less than 12 mm. Such a small diameter requires only a very small incision for the implantation surgery. In addition, such a small diameter enables the neuroregulator device to be placed in the body in such a way that it is not felt or perceived by the patient after implantation.

[0049] According to another embodiment of the present invention, the length of the housing, preferably including the molding head and / or overmolding, is less than 50 mm, preferably less than 46 mm, and particularly preferably less than 44 mm. Such a relatively small length of the neuroregulator device, especially in combination with a small maximum diameter, results in a very small and compact neuroregulator device that can be further implanted with a relatively easy surgical procedure and can be further placed in or implanted into the body without the patient feeling or perceiving the implant, especially during various body activities after implantation.

[0050] In another preferred embodiment of the present invention, in addition to at least one antenna, a rechargeable energy storage device, an electrical control unit, and pulse generating means are arranged within the housing. In a particularly preferred embodiment, the implantable neuroregulator device includes only a single antenna for data / information transmission (send / receive) and energy reception or charging of the rechargeable energy storage device.

[0051] This allows for long-term use of the neuroregulator device and initial implantation without the need for further surgery that would allow the device to be recharged and would further enable external adjustment of the control parameters of the device after implantation.

[0052] In a preferred embodiment, the rechargeable energy storage device is a solid-state battery, preferably two solid-state batteries. Such an energy storage device has several advantages over other energy storage devices (such as lithium-ion batteries / accumulators), especially with respect to long-term use or a large number of charging or recharging cycles.

[0053] The use of two solid-state batteries has the following advantages: Even if one battery is inactive, for example due to a charging activity or due to a fault or damage, the device can still operate safely and can output stimulation pulses.

[0054] Another preferred embodiment of the invention requires that the electrical control unit includes two charging circuits, each charging circuit being arranged to charge a separate rechargeable energy storage device. As described above, those independent charging circuits are capable of charging the device or the energy storage device while performing neuromodulation by delivering electrical pulses to the electrode leads or the electrodes.

[0055] This can minimize the total number of charging cycles of each energy storage device, thereby maximizing the lifespan of the corresponding energy storage device.

[0056] According to another preferred embodiment, the neuromodulator device includes a rigid support member within the housing, which is preferably made of a fiber-reinforced resin, especially a printed circuit board. The support member can be used to mechanically support and electrically connect most of the electronic or electrical components of the neuromodulator device, such as a microcontroller, a pulse generating device, and electrical control components.

[0057] In another preferred embodiment, the support member extends substantially over the entire length and the entire width of the internal space defined by the housing, preferably at a certain eccentric height level of the housing, dividing the space defined by the housing into a smaller first cavity and a larger second cavity of the housing, each cavity being defined by a part of the housing and one side of the support member, respectively.

[0058] In a particularly preferred embodiment, at least one rechargeable energy storage device (preferably all rechargeable energy storage devices) is placed in the larger second cavity of the housing.

[0059] In another preferred embodiment, the openings in the feedthrough elements, especially the height level and / or the electrical contact elements, are arranged in such a way that two of the electrical contact elements are arranged in the second cavity at the inner side of the feedthrough element, and two electrical contact elements are arranged in the first cavity of the housing at the inner side of the feedthrough element.

[0060] According to another preferred embodiment of the present invention, at least one antenna (preferably the only antenna) is designed as a large-aperture antenna, preferably having a receiving cross-section greater than 0.1×A×B, preferably greater than 0.2×A×B, and particularly preferably greater than 0.4×A×B, where A is the length of the housing and B is the width or diameter of the housing. The large-aperture antenna enables efficient energy transfer to be carried out fully effectively within a relatively small housing, and also enables a large tolerance for the relative placement or arrangement of another antenna for coupling with the antenna of the device. For such an arrangement, the antenna must be oriented or arranged relatively close to the inner surface of the housing portion to achieve the largest possible aperture within the housing. The large-aperture antenna makes it possible to have effective energy transfer and control communication while keeping the overall volume of the neuromodulator device to a minimum.

[0061] In another preferred embodiment, the receiving cross-section of the antenna is aligned parallel to the fixing wing of the overmolding and / or parallel to the guiding member of the molding head.

[0062] In another preferred embodiment, at least one antenna (preferably only any one antenna) is designed to have a thickness of less than 3 mm, preferably less than 2 mm, at a right angle to the receiving cross-section. Thus, the antenna can be assembled inside the circular cross-section of the housing.

[0063] In another preferred embodiment, at least one antenna (preferably only the antenna) includes a coil preferably in a substantially rectangular shape, where the coil is arranged at an angle (preferably at a right angle) to the plane of the support member. This arrangement of the antenna relative to the support member makes it possible to pack all the internal components very densely into the housing without negatively affecting the possible aperture of the antenna or the aperture surface of the antenna within the housing.

[0064] In a preferred embodiment, the antenna coil is arranged in the first cavity and the second cavity of the housing, and the coil passes through a channel in the support member, and the channel is arranged at two opposite ends of the support member (preferably along the length or longitudinal direction). This embodiment also allows the antenna to have a maximized aperture or receiving cross-section, which has the space defined by the housing.

[0065] According to another preferred embodiment, the antenna includes a printed circuit board having several different layers, and each layer of the board carrying the winding of at least one antenna coil is arranged parallel and adjacent to each other. This provides the necessary coil length by conveniently stacking the circuit board layers. The coil or coil portion of the antenna can be printed onto the circuit board.

[0066] In another preferred embodiment, the support member includes a cut at at least one end in the length / longitudinal direction of the support member, allowing the antenna to be positioned (preferably slid) into the channel. The cut provides an easy way to assemble the neuromodulator device.

[0067] For example, a support member that may also carry an energy storage device on one of its sides and other electrical components on one or both of its sides can be pre-assembled. In the next assembly step, the pre-assembled antenna can be placed on the support member, in particular can slide on the support member, and the antenna is facilitated by a cutout and reaches into a channel such that the antenna passes through the support member at two ends of the support member at an angle (preferably a right angle) with respect to the plane of the support member. Then, the assembly of the support member with the electrical or electronic components (which may already include the energy storage device and the antenna, possibly after electrically and / or mechanically connecting the antenna to the support member) can be placed into the first housing part. Thereafter, the second housing part can be placed on top of the first housing part such that the sealing rings contact each other. In this step, the electronic contact elements that can be pre-assembled or connected to the support member can be fed through an opening in the feed-through element. Thereafter, the housing can be sealed, in particular by sealing the two sealing rings using gold brazing and by sealing the space between the opening, the feed-through element, and the electrical contact element. The connection or sealing between the container and the first sealing ring, and between the second sealing ring and the feed-through element can be achieved or formed before connecting the first housing part to the second housing part. Thereafter, the electrical contact element can be connected to the electrode or the electrode lead before the molding head or overmolding is molded on a part of the housing or the entire housing.

[0068] In another preferred embodiment, the neuromodulator device may include a sensor to measure the temperature near the implant. This allows for the identification of an inflammatory response of the body or a fever of the patient. The regulator device may further include means to transmit the measured temperature via at least one antenna (preferably via a single antenna).

[0069] The above technical problem is also solved by a system including a neuromodulator device according to any of the foregoing embodiments, and a wearable and / or hand-held electronic device, wherein the wearable and / or hand-held electronic device includes an energy storage device and a communication interface for establishing a communication connection with the neuromodulator device.

[0070] Wearable and / or handheld devices (hereinafter referred to as: wearable electronic devices) can be designed as patient or user devices for the regular use of patients or users. Preferably, the energy storage device of the wearable device can be recharged, for example, via a primary cell cable connection, preferably using a cable device with charging contacts, or a separable cable, or via wireless energy transfer and transmission. The communication interface can rely on standard communication protocols such as NFC, BLE, RFID, etc. However, the communication interface can use other communication protocols. A system including a neurostimulator and a wearable device enables a patient to conveniently use the neurostimulator device over a long period of time, as the system provides the infrastructure or necessary devices for communicating with the implanted neurostimulator device and recharging the implanted neurostimulator device.

[0071] According to a preferred embodiment, the wearable electronic device includes a wireless energy transmission unit connected to the energy storage device of the wearable device, and the energy transmission unit is used to transmit energy to the neurostimulator device, and the neurostimulator device is used to receive and store the transmitted energy. Preferably, the transmitted energy is received through at least one (preferably only one) antenna of the neurostimulator device, and the received energy is stored in the rechargeable storage device of the regulator device. In this embodiment, wireless energy transfer from the wearable device to the neurostimulator device is enabled. The advantage of having a wearable electronic device is that the user or patient can easily and conveniently charge the neurostimulator device during normal daily life and / or during nighttime sleep, especially in a significant number of cases on any given day, making it very convenient to operate the implanted neurostimulator device over a long period of time.

[0072] In a further preferred embodiment, the wearable electronic device includes a wireless transmission device, especially an antenna for establishing a communication connection with the neurostimulator device and for transmitting energy to the neurostimulator device. According to this embodiment, the electronic wearable device includes only a single wireless transmission device, especially an antenna for both recharging the neurostimulator device and transmitting data from the neurostimulator device to the wearable device (and vice versa). This reduces the components required for the wearable device.

[0073] In another embodiment, the system includes underwear (preferably made of a fabric material) having retaining means (in particular a fabric pocket) for retaining the neuromodulator device. As previously mentioned, one possible application of the neuromodulator according to the present invention is to modulate nerves in the pubic region. After implantation in this region of the body, pants, and in particular underwear, provide a favorable and convenient support structure such that when the underwear is worn by the patient or user, it brings a wearable electronic device, and in particular any transmission device (such as an antenna), into sufficient proximity to the implanted neuromodulator device. Electrical components can be integrated into parts of the fabric (e.g., between a fabric pocket or fabric layers), or integrated into a housing made of a material different from the underwear and fixed or connected to the underwear.

[0074] In an alternative but equally preferred embodiment, the wearable electronic device is detachably connected to a seat belt, preferably to a belt or hip belt of the system. In other words, the system can include a belt, in particular a hip belt or harness, having receiving means, in particular self-fixing means, for receiving and fixing the neuromodulator device to the belt or harness. Similar to the previous embodiment of the underwear, the belt or harness can be conveniently worn by the patient or user and can bring the wearable electronic device and its electronics (in particular an antenna) into the necessary proximity to the implanted neuromodulator device located in the pubic region in order to transmit energy to the neuromodulator device and / or receive data or information from the neuromodulator device.

[0075] According to another preferred embodiment, the wearable electronic device is capable of operating in at least two different operating modes, where the first mode is a charging and communication mode, and where the second mode is a setting or programming or parameter selection mode. The second mode can be activated during the initial surgical implantation of the neuromodulator device. The second mode can also be activated after the wearable device is connected to a special device that is only available to medical professionals such as doctors and nurses. The second operating mode enables the adaptation of all kinds of programming and operating parameters of the neuromodulator device, including critical operating parameters and settings.

[0076] In another preferred embodiment, the wearable electronic device is configured to perform measurements indicating alignment, in particular a special alignment relative to the neuromodulator device, in particular a special alignment relative to the antenna of the neuromodulator device. This can assist the surgeon in positioning the neuromodulator device during the implantation surgery in such a way that the best possible alignment between the wearable device outside the body and the implanted neuromodulator device inside the body is achieved, thus allowing the best possible communication between the wearable device and the most efficient energy transfer after implantation.

[0077] In another preferred embodiment, the wearable electronic device is configured to generate or cause an output, in particular an audio output or a visual output, which indicates the corresponding position and / or orientation of the neuromodulator device (in particular the position and / or orientation of the antenna of the neuromodulation device relative to the wearable electronic device) when operating in a setting or programming or parameter selection mode (i.e., the second operating mode). This is a convenient way to align the neuromodulator device with the wearable electronic device during the initial implantation surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0078] The present invention will be described in further detail on the basis of the following drawings showing particular embodiments of the invention. These drawings show: Figure 1 is a schematic view of an implantable neuromodulator device in a first embodiment of the present invention; Figure 2 is a schematic view of the housing of an implantable neuromodulator device according to the present invention; Figure 3 is a schematic view of an implantable neuromodulator device according to the present invention; Figure 4 is a schematic view of the housing of an implantable neuromodulator device according to the present invention; Figure 5a is a schematic view of the first side of a support member of an implantable neuromodulator device according to the present invention; Figure 5b is a schematic view of the second side of a support member of an implantable neuromodulator device according to the present invention; Figure 6a is a schematic view of a pre-assembled part of an implantable neuromodulator device according to the present invention; Figure 6b is a schematic view of a pre-assembled part of an implantable neuromodulator device according to the present invention; Figures 7a - 7c is a schematic view of a pre-assembled part of an implantable neuromodulator device according to the present invention; Figure 8 is a schematic view of a system of the present invention including an implantable neuromodulator device according to the present invention and a wearable electronic device. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0079] Figure 1 A first embodiment of an implantable neuromodulator device 1 of the present invention is shown. The neuromodulator device 1 has a housing 2 which includes a first housing part 3 and a second housing part 4. On the outside of the first housing part 3 and the second housing part 4, a coating mold 5 is molded onto the outer surface of the housing 2.

[0080] In Figure 1In an embodiment, the overmolding 5 covers the entire housing 2, and the overmolding 5 further includes a molded head 6 and fixing wings 7. The fixing wings 7 and the molded head are arranged on opposite sides of the housing 2. The head 6 includes a guiding member 8, and the guiding member 8 forms an angle of 30° to 70° with respect to the longitudinal axis L of the neuromodulator device 1. The structured surface 38 of the fixing wings connected to each other via the holes 39, and the electrode lead 9 guided within the guiding member 8 are preferably arranged in parallel planes. The guiding member 8 can be used to guide the electrode lead 9 into and out of the neuromodulator device 1, especially in a specific direction and / or orientation with respect to the housing and its interior. The holes 39 can be used as suture holes or for autologous fixation of the device 1.

[0081] The electrode lead 9 in the fixing wing 7 and / or the guiding member 8 can be arranged in a parallel plane with respect to the receiving cross-section of the antenna of the device ( Figure 1 not shown in the figure). Thus, the orientation of the internal part of the device can be known from the external design.

[0082] There is a fishbone member 10 within the molded head 6, and the fishbone member 10 allows for better adhesion and connection with the molding material in the area of the molded head 6. The electrode lead 9 is at least electrically connected to an electrical contact element 11, and the electrical contact element 11 extends through the second housing part 4 into the interior of the housing 2. The fixing wings 7, the overmolding 5, and the molded head 6 can be made of an integral molding material, preferably a biocompatible polymer resin.

[0083] The overmolding 5, especially the molded head 6, also adheres and / or fixes to the electrode lead 9, improving the inseparable permanent mechanical connection between the device and its antenna.

[0084] Figure 2 The housing 2 and the corresponding first housing part 3 and second housing part 4 are shown in more detail. It can be seen that the first housing part 3 includes a container 12 having a circular cross-section, an end 13 that is closed and rounded on one side, and a first sealing ring 14 on the opposite side. The container 12 can preferably be made of an integral ceramic material.

[0085] The first sealing ring 14 can preferably be made of titanium or surgical steel. As can already be seen from Figure 2 the figure, the outward structure 15 of the first sealing ring 14 can have a stepped surface. The stepped surface can help to align and seal the housing parts and / or the sealing rings 14, 16 with each other.

[0086] The second housing part 4 may also include a second sealing ring 16 and a feedthrough element 17. The feedthrough element 17 may have one or more openings 18 through which the electrical contact element 11 may electrically connect one side of the feedthrough element 17 to the other side of the feedthrough element 17. The feedthrough element 17 may also be made of a ceramic material and may have a disc-like or disk-shaped form. The feedthrough element 17 may be placed entirely within the inner space of the second sealing ring 16.

[0087] As Figure 2 shown, the openings 18 may be arranged at two different height levels, where the height levels are defined by lines perpendicular to a diameter line passing through the center of the feedthrough element 17.

[0088] Figure 2 Shown are the first housing part 3 and the second housing part 4 separated from each other in the open state of the housing 2. By sealing the first sealing ring 14 and the second sealing ring 16 together (preferably by gold brazing), the housing 2 can be hermetically sealed, especially when the space between the electrical contact element 11 and the openings 18 is also filled with gold brazing or an alternative material that ensures electrical isolation of the electrical contact element 11.

[0089] Figure 3 Depicted is an implantable neurostimulator device 1 similar to Figure 1 and Figure 2 where the housing 2 is shown in a translucent mode. Figure 3 The overmolding is not shown in

[0090] However, the interior of the neurostimulator device 1 can be seen. Inside the housing 2 of the neurostimulator device 1 there is an antenna 19, a rechargeable energy storage device 20, and a support member 21. The support member 21 mechanically supports other components, especially the electronic or electrical components of the neurostimulator device 1, and electrically connects them. The support member 21 also provides a connection to the electrical contact element 11, although this connection is not clearly visible in the Figure 3 presentation. The support member 21 may include a printed circuit board (PCB).

[0091] Figure 3 The embodiment of

[0092] shows a single rechargeable energy storage device 20. In an alternative and advantageous embodiment, two or more rechargeable energy storage devices 20 can be used. The support member 21 is eccentrically arranged within the interior of the housing 2, and the support member 21 divides the inner space of the housing into a first cavity 22 with a smaller volume and a second cavity 23 with a larger volume. The rechargeable energy storage device 20 is arranged within the second cavity 23, and the rechargeable energy storage device 20 is further arranged within the opening or receiving cross-section 24 of the antenna 19.

[0093] If two or more rechargeable energy storage devices 20 are used, they can all advantageously be arranged within a larger second cavity 23 and further within the aperture or receiving cross-section 24 of the antenna 19.

[0094] The antenna 19 can be made of several layers of printed circuit boards, with each printed circuit board carrying one or more printed windings of the antenna coil. The antenna 19 can also be electrically connected to the support member 21. In an alternative preferred embodiment, the antenna can also include several windings of preferably uninterrupted wires, which are wound around a carrier structure, preferably made of an electromagnetically transparent material, similar to the material that can be used for the housing as defined above. Preferably, the carrier structure can be made by 3D printing or by injection molding of plastic. The carrier structure can be made of one or more parts.

[0095] The antenna 19 has a substantially rectangular shape. The antenna 19, especially the receiving cross-section 24 of the antenna 19, is preferably arranged at an angle, especially a right angle, to the plane of the support member 21. The manner in which the antenna 19 is mounted above or around the support member 21 and the rechargeable energy storage device 20 will become more apparent with reference to FIGS. 5 to 6. The antenna 19 is designed as a large-aperture antenna, preferably having a receiving cross-section 24 greater than 0.1×A×B, where A is the length of the housing 2 and B is the width or diameter of the housing 2.

[0096] Figure 4 Parts of the first housing part 3 and the second housing part 4 are shown, including the first sealing ring 14 and the second sealing ring 16. It can be seen that, in addition to the stepped outward structure 15, the first sealing ring 14 has sleeve extensions 25 at opposite ends to receive the container 12 within the sleeve extensions 25. This facilitates the arrangement and connection of the container 12 to the first sealing ring 14.

[0097] The stepped outward structure 15 is for contacting the corresponding stepped inward surface 26 of the second sealing ring 16, facilitating the alignment and connection or sealing of the first sealing ring 14 and the second sealing ring 16.

[0098] Figure 5a A first side of the support member 21 carrying electronic components (such as a microcontroller, an operational amplifier, a field-effect transistor, passive components, etc.) is shown.

[0099] The support member 21 has a first channel 27 and a second channel 28 on opposite sides in the length or longitudinal direction L of the support member 21. Perpendicular to Figure 5aIn the image plane, the antenna 19 can pass through the support member in the channels 27 and 28. To enable the antenna to slide on the support member 21 and / or on the rechargeable energy storage device 20, the support member 21 further includes a cutout 29 which enables the support member to be arranged at an angle (preferably a right angle) relative to the antenna 19, and the cutout 29 also enables the antenna 19 to pass through the support member or stretch to both sides of the support member 21.

[0100] When a coil antenna wound around a carrier structure is used instead of an antenna based on multiple PCB layers, the cutout 29 can be eliminated. In this case, the carrier structure is made of two different parts that can be fixed to both sides of the support member 21. Then, after placing the carrier structure above and below the support member 21, the coil can be wound around the carrier. In this embodiment (not shown in the figure), the channels can also be made smaller or eliminated.

[0101] Figure 5b The opposite sides of the support member 21 are shown, also having channels 27, 28 and the cutout 29. In Figure 5b the depiction, there are two rechargeable energy storage devices 20 arranged on the second side of the support member 21. The two rechargeable energy storage devices 20 can preferably be solid-state batteries.

[0102] Figure 6a A pre-assembled part of the implantable neuro-regulator device 1 is shown, in which a second housing part 4 including the electrical contact element 11 is electrically connected to the support member 21, which in turn is connected to the rechargeable energy storage device 20 and the antenna 19. Figure 6a A view of the pre-assembled part in a plane parallel to the plane of the support member 21 is shown. The plane of the receiving cross-section 24 or the opening of the antenna 19 is arranged at a right angle to the plane of the support member.

[0103] Figure 6b A view is shown of the pre-assembled part of the implantable neuro-regulator device 1 rotated by approximately 90° about the longitudinal axis L according to Figure 6a In this view, the receiving cross-section 24 of the antenna 19 is parallel to the image plane and the support member 21 or the plane of the support member 21 is at a right angle to the receiving cross-section 24 and the image plane. In this representation, a single antenna winding 30 is partially visible, which is formed on a plurality of printed circuit board layers that form the antenna 19 and are arranged adjacent to each other.

[0104] From Figure 6b it can also be seen that the support member 21 is arranged eccentrically with respect to the cross-section or diameter of the housing 2.

[0105] Figures 7a to 7cShows another representation of the support member 21 with a plurality of electrical and electronic components attached thereto. Together with the antenna 19 and the rechargeable energy storage device 20, the support member 21 is placed within the first housing part 3 through the opening of the first sealing ring 14.

[0106] Figure 7b Depicts the support member 21 and the antenna 19 in a state where they are fully inserted into the housing, especially the first housing part 3. The support member 21 extends substantially along the entire length and across the entire width inside the first housing part 3 at an eccentric height level. As shown in Figure 2 , Figure 4 and Figure 7c depicted, since the second housing part 4 does not significantly increase the length or width of the internal space of the housing 2, this also means that the support member 21 and the antenna 19 preferably extend along substantially the entire length and the entire width of the internal space of the housing 2.

[0107] Figure 8 Shows a possible embodiment of the system of the present invention including the implantable neuroregulator device 1 of the present invention. The system also includes two wearable and / or handheld electronic devices 31. The system only requires one wearable and / or handheld electronic device 31 (hereinafter referred to as the wearable device). The two wearable devices 31 only show different embodiments of the wearable device 31 that can operate within the system of the present invention.

[0108] One of these wearable devices 31 can be inserted into a pair of underwear 32 of the system. The wearable device 31 is preferably made of a fabric material. The second wearable device 31 includes a wire harness, especially a belt 33, preferably a hip belt. The two wearable devices 31 include a wireless transmission device 34 that is connected to the wireless energy transmission unit 35 and the combined input and output interface 36 of the wearable electronic device 31, such as a touch display. The combined input and output interface 36 can also be replaced by a single input interface such as a button and one or more output interfaces such as a display.

[0109] The wireless transmission device 34 is capable of connecting to the neuroregulator device 1 via the antenna 19 not shown in Figure 8 . The combined input and output interface 36 can be used to control the wearable device 31 and thus also remotely control the neuroregulator device 1. The wearable device 31 can operate in a first operation mode accessible to all users and a second operation mode accessible only to medical professionals.

[0110] When the neuromodulator device 1 approaches the wearable device 31 (especially the wireless transmission device 34 of the wearable device 31), the wearable device 31 can be used to charge the neuromodulator device 1 and send data or information to the neuromodulator device 1 and / or receive data or information from the neuromodulator device 1.

[0111] The patient or user can change the first set of parameters of the neuromodulator device 1 by inputting to the combined input and output interface 36 of the wearable device 31. In the first operating mode, the first set of parameters can be defined such that changing the parameters has a comfortable or convenient effect on the patient. In the second operating mode, the second set of parameters that can be changed can include the first set of parameters and additional parameters, and can preferably include parameters related to the more general and critical operating characteristics of the neuromodulator device 1.

[0112] List of reference numerals: 1 Implantable neuromodulator device 2 Housing 3 First housing part 4 Second housing part 5 Overmolding 6 Molded head 7 Fixed wing 8 Guide member 9 Electrode lead 10 Fishbone member 11 Electrical contact element 12 Container 13 End 14 First sealing ring 15 Outward structure 16 Second sealing ring 17 Feedthrough element 19 Antenna 20 Rechargeable energy storage device 21 Support member 22 First cavity 23 Second cavity 24 Receiving cross-section 25 Sleeve extension 26 Inner surface 27 First channel 28 Second channel 29 Notch 30 Winding 31 Wearable device 32 Underwear 33 Band 34 Wireless transmission device 35 Wireless energy transmission unit 36 Communication interface 38 Surface 39 Hole L Longitudinal axis

Claims

1. An implantable nerve regulator device, comprising an airtight housing (2), wherein, An antenna (19) for communication with an external device and / or for wirelessly receiving electrical energy is positioned within the housing (2), wherein a major portion of the housing (2) is electromagnetically transparent to radiation in a frequency range below 20 MHz, particularly between 5 MHz and 15 MHz.

2. The neuromodulator device according to claim 1, wherein, The electromagnetically transparent portion of the housing is made of plastic, resin, glass, ceramic, or a combination thereof.

3. The nerve regulator device according to claim 1 or 2, wherein, The housing (2) has a circular cross-section, preferably has a tubular or cylindrical shape, and includes a first housing portion (3) and a second housing portion (4), wherein the first housing portion (3) includes a container (12) having a circular cross-section, the container (12) being closed at one end (13) and preferably rounded, and having a first sealing ring (14) at the opposite or second end.

4. The nerve regulator device according to claim 3, wherein, The container (12), particularly together with the closed and preferably rounded end (13), is machined, particularly turned, from a single-piece material, particularly a ceramic material.

5. The neuromodulator device according to claim 3 or 4, wherein, The second housing portion (4) includes a second sealing ring (16) and a feedthrough element (17), the feedthrough element (17) including at least one opening (18) in which an electrical contact element (11) can electrically connect one side of the feedthrough element (17) to a second side of the feedthrough element (17).

6. The neuromodulator device according to claim 5, wherein, The contact element (11) is electrically connected to an electrode lead (9) for outputting an adjustment pulse to a patient.

7. The nerve regulator device according to any one of claims 1 to 6, the nerve regulator device including a molded part (5), the molded part (5) including a molded head (6) preferably made of a biocompatible polymer resin, the molded head (6) covering at least part of the electrical contact element (11) and the corresponding opening (18) in the feedthrough element (17) on one side of the feedthrough element (17).

8. The nerve regulator device according to claim 7, wherein, The molded part (5) includes at least one opening and / or suture hole for autologous fixation of the device and / or for suturing the device to tissue material or bone material.

9. The neuromodulation device of claim 7 or 8, wherein, An end portion of the molded head (6) opposite the second housing portion (4) includes a guiding member (8) for guiding the electrode lead (9), wherein the guiding member (8) is formed at an angle with respect to the longitudinal axis (L) of the housing (2), preferably 30° to 70°.

10. The neuromodulation device according to any one of claims 3 to 9, wherein, The molded part (5) covers the entire first and second housing portions (3, 4), and further forms a molded head (6) and / or fixing wings (7).

11. The neuromodulator device according to claim 10, wherein, The fixing wings (7) are formed at an end of the housing (2), preferably adjacent to the first housing portion (3), or with respect to the molded head (6) and the electrode lead (9).

12. The neuromodulator device according to claim 10 or 11, wherein, The fixing wings (7) are formed in a plane parallel to the longitudinal axis (L) of the housing (2), preferably in a plane the same as or parallel to the electrode lead (9) within the guiding member (8).

13. The nerve regulator device according to any one of claims 1 to 12, wherein, The ratio of the maximum diameter of the housing to the length of the housing (2) is less than 0.

35.

14. The neuromodulator device according to any one of claims 1 to 13, wherein, The maximum diameter of the housing (2) is less than 12 mm, preferably less than 10 mm.

15. The neuromodulator device according to any one of claims 1 to 14, wherein, The length of the housing (2) is less than 50 mm, preferably less than 46 mm, particularly preferably less than 44 mm.

16. The nerve regulator device according to any one of claims 1 to 15, wherein, Inside the housing (2), there is arranged a rechargeable energy storage device (20), an electrical control unit and a pulse generating device, in addition to at least one of the antennas (19).

17. The neuromodulator device according to claim 16, wherein, The rechargeable energy storage device (20) is a solid-state battery, preferably two solid-state batteries.

18. The neuromodulation device according to claim 16 or 17, wherein, The electrical control unit includes two charging circuits, each of which is arranged to charge a separate rechargeable energy storage device (20).

19. The nerve regulator device according to any one of claims 1 to 18, wherein, The support member (21) extends substantially over the entire length and the entire width of the internal space defined by the housing (2), preferably at a certain eccentric height level of the housing (2), dividing the space defined by the housing (2) into a smaller first cavity (22) and a larger second cavity (23) of the housing (2), each cavity being defined by a part of the housing (2) and one side of the support member (21).

20. The neuromodulation device according to any one of claims 16 to 19, wherein, At least one of the rechargeable energy storage devices (20), preferably all energy storage devices, is placed in the larger second cavity (23) of the housing (2).

21. The neuromodulation device according to any one of claims 1 to 20, wherein, At least one of the antennas (19) is designed as a large-aperture antenna, preferably having a reception cross-section greater than 0.1×A×B, more preferably greater than 0.2×A×B, where A is the length of the housing and B is the width or diameter of the housing.

22. The neuromodulator device according to any one of claims 1 to 21, wherein, At least one of the antennas (19) includes a coil, preferably having a substantially rectangular shape, wherein the coil is arranged at an angle, preferably a right angle, with respect to the plane of the support member (21).

23. A nerve regulator system, comprising an implantable nerve regulator device (1) according to any one of claims 1 to 33, and a wearable and / or hand-held electronic device (31), wherein, The wearable and / or hand-held electronic device (31) includes an energy storage device and a communication interface for establishing a communication connection with the neuromodulator device (1).

24. The system according to claim 23, wherein, The wearable and / or hand-held electronic device (31) includes a wireless energy transmission unit connected to the energy storage device of the wearable and / or hand-held electronic device (31), the energy transmission unit being configured to transmit energy to the neuromodulator device (1), and the neuromodulator device (1) being configured to receive and store the transmitted energy, preferably in at least one of the rechargeable energy storage devices (20) of the neuromodulator (1).

25. The system according to claim 23 or 24, wherein, The wearable and / or hand-held electronic device (31) includes a wireless transmission device (34), in particular an antenna for establishing a communication connection with the neuromodulation device (1) and transmitting energy to the neuromodulation device (1).

26. The system according to claims 23 to 25, the system including underwear (32), preferably made of a fabric material, the underwear (32) having retaining means, in particular a fabric pocket, for retaining the neuromodulator device (1).

27. The system according to claims 23 to 25, the system including a harness, in particular a belt or a hip belt, having receiving means, in particular self-fixing means, for receiving and fixing the neuromodulator device (1) to the belt or the harness.

28. The system according to any one of claims 23 to 27, wherein, The wearable and / or hand-held electronic device (31) is capable of operating in at least two different operating modes, wherein a first mode is a charging and communication mode, and wherein a second mode is a setting or programming or parameter selection mode.

29. The system according to any one of claims 23 to 28, wherein The wearable and / or hand-held electronic device (31) is configured to perform measurements indicative of alignment with the neuromodulator device (1), in particular measurements indicative of alignment with the antenna (19) of the neuromodulator device (1).

30. The system according to any one of claims 23 to 29, wherein The wearable and / or hand-held electronic device (31) is configured to generate or cause an output, in particular an audio output or a visual output, indicative of the relative position and / or orientation of the neuromodulator device, in particular indicative of the antenna (19) of the neuromodulator device.

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