Needle device for placement on an auricle

Abstract

The present invention relates to a needle device (105) configured for placement or placement on the auricle and / or earlobe, wherein the needle device (105) has a handle device (400) and / or a placement unit (400) for placing the needle device (105) on the auricle and / or earlobe.

Description

Technical Field

[0001] The submitted invention relates to a needle device for placement on the auricle, a nerve stimulation device for electrically stimulating at least one nerve, and a method for using the needle device, as described in the independent claims. Background Technology

[0002] Nerve stimulation, more precisely, electrical stimulation of peripheral nerves, is well-known and used in a variety of conditions, such as peripheral arterial disease, inflammation, or atrial fibrillation for pain management or relief. This electrical stimulation of peripheral nerves can be performed through various methods:

[0003] In transcutaneous nerve stimulation (TENS), electrodes can be used, which are placed in painful areas of the skin or in nerve pathways, for example, to deliver electrical pulses.

[0004] In percutaneous nerve stimulation (PENS), the corresponding nerve can be stimulated more directly. Here, electrodes can either be implanted subcutaneously within the framework of a surgical procedure or can be in the form of acupuncture needles.

[0005] In TENS and / or PENS, when the stimulating electrode is sufficiently close to the nerve, the electrical impulses delivered by the electrode can cause depolarization on the corresponding nerve. Localized sensory abnormalities typically occur at the afferent nerve endings. The electrode or injection needle should not be in direct contact with the nerve.

[0006] The vagus nerve, in particular, has traditionally been chosen as a directional nerve for electrical stimulation and / or, for example, for improving and / or treating various medical and non-medical conditions. The vagus nerve, the tenth cranial nerve and the longest, is an important part of the parasympathetic nervous system and can be considered a bidirectional connection between the body and the brain. It extends from the brainstem to the proximal two-thirds of the colon, innervating several thoracic and abdominal visceral organs along this pathway. The vagus nerve is a mixed nerve, consisting of 20% efferent fibers and 80% afferent fibers. Stimulation of this nerve can be performed, for example, via the auricular branch of the vagus nerve. Alternatively, stimulation of the vagus nerve in the neck (the cervical branch) is also feasible. Summary of the Invention

[0007] The objective of the present invention is to provide an improved needle device for placement on the auricle, a placement unit, an improved neurostimulation device for electrically stimulating at least one nerve, and an improved method for using the needle device, according to the independent claims. Advantageous designs and improvements are derived from the dependent claims and the following description.

[0008] According to the proposed solution herein, the task is accomplished by an improved needle device for placement on the auricle, an improved neurostimulation device for electrically stimulating at least one nerve, and an improved method of using the needle device having the features or steps of the independent claim. Advantageous designs and improvements of the proposed solution are derived from the description and the following dependent claims.

[0009] To address the aforementioned task, the present solution provides a needle device configured for placement or placement on the auricle and / or earlobe, wherein the needle device has a handle device and / or a placement device for placing the needle device on the auricle and / or earlobe.

[0010] A needle device can generally be understood as a technical structural element having at least one or more needles that can be energized or subjected to voltage, thereby transmitting electrical pulses to a body part connected to the needle. These (electrical) pulses can be provided by a pulse device and transmitted to the ear or earlobe via a needle device that can be coupled to the pulse device.

[0011] Here, the needle device (which may also be referred to as a needle unit) may have a handle, which in this specification may also be referred to as a handle device for placing the needle device on the auricle and / or earlobe. Alternatively or additionally, a placement device may be used to place the needle device on the auricle and / or earlobe. By using the handle device (which may also be referred to as a manipulator or a removable manipulator), the needle device can be easily and aseptically positioned on the auricle and / or earlobe by a user or medical personnel. By breaking the handle device (which may also be referred to as a guide rod), repeated, potentially non-aseptic use of the needle device becomes virtually impossible. When using a placement device, the needle unit can, for example, be quickly, non-destructively, and therefore stably positioned detached from the handle or placement unit.

[0012] This solution is based on the understanding that traditional techniques can be widely applied in both medical and home applications. For this purpose, it is advantageous, in particular, to simplify the placement and / or installation of electrodes on the ear. This simplification is achieved by separating or enabling the needle device from the pulse device, thus allowing the needle device to be individually secured to the ear or earlobe. This provides the advantage that the needle device can be placed without significant interference from the pulse device, enabling electrical connection between the needle device and the pulse device after placement without causing displacement of the needle from its desired position and resulting in mispositioning.

[0013] An advantageous embodiment of the scheme described herein is that the needle device has a predetermined break point for separating the handle device from the needle device. Alternatively or additionally, the needle device placement device can be configured as tweezers and / or clamps, and / or the needle device placement device has locking elements and / or snap-locking elements and / or magnetic locking elements for non-destructive separation of the needle from the placement device. This provides the advantage that the handle device or placement device can be easily and user-friendly removed from the needle device while still achieving very accurate positioning.

[0014] Another conceivable implementation of the scheme described herein is that the needle device is detachably or capable of being connected to the pulse device via at least one magnetic contact, wherein the pulse device is coupled or capable of being coupled to the needle device for delivering at least one electrical pulse to the auricle and / or earlobe, and / or wherein the needle device is detachably connected or capable of being connected to the pulse device via at least one clip or tweezers. The pulse device (also referred to herein as a pulse generating device) may include, or may be constituted by, a flexible connecting portion having magnetic contacts. This flexible connecting portion can, must, or will be connected to the magnetic contacts of the needle device. This magnetic connection between the needle device and the pulse device (also referred to herein as a detachable connection) ensures that the two devices are connected in the correct positioning and orientation, respectively, i.e., they can be simply guided to the vicinity of the corresponding other device, for example. This avoids complex connection operations performed by the user or assistant, instead enabling a simple connection between the needle device and the pulse device.

[0015] Furthermore, an advantageous embodiment of the scheme described herein is that the needle device can be shaped as at least one electrode needle and / or as at least one microneedle and / or as a needle element having at least two needles, particularly wherein at least one electrode needle and / or at least one microneedle can be shaped from a biocompatible material, especially from a biocompatible metal. By using the special shapes of the electrode needle and / or microneedle and / or needle element (adapted to the shape of the auricular region or earlobe to which the needle or needle device will be positioned), for example, it is possible for a user or medical professional to properly secure the needle in or to the auricle or other area of ​​the ear. Simultaneously, electrical pulses can be delivered to the ear or earlobe very efficiently and effectively. Such a variation also provides the advantage that the needle can be placed inside or on the patient in a health-insensitive manner for the purpose of treatment or treatment, without causing irritation to the body tissue at the site of needle insertion.

[0016] In another embodiment, the needle device may have at least one adhesive element for securing the needle device to the auricle and / or earlobe. This, in particular, simplifies or improves the fixation of the needle device to the auricle and / or earlobe.

[0017] Furthermore, the scheme described herein also provides a nerve stimulation device for electrically stimulating at least one nerve in at least one auricle and / or at least one earlobe. This nerve stimulation device has the following characteristics: - According to a variant of the needle device described herein, the needle device is configured for placement or placement on the auricle and / or earlobe; and - A pulse device for generating electrical pulses that can be separated from the needle device, wherein the pulse device is coupled to or can be coupled to the needle device for delivering at least one electrical pulse to the auricle and / or earlobe.

[0018] This neurostimulation device can be used, for example, to improve or treat a variety of medical applications, or to enhance user comfort, such as to relieve muscle tension, reduce pain in peripheral arterial disease, inflammation, or atrial fibrillation.

[0019] According to one embodiment, the pulse device can be configured to deliver electrical pulses in the current intensity range of 0.05 mA to 1.2 mA. According to an additional embodiment, the nerve stimulation device (also referred to as an otoneurotic stimulator or stimulation unit) can operate with a current of 0.4 mA to 1.2 mA. According to another embodiment, the otoneurotic stimulator can operate with a current of 0.4 mA under standard settings. Delivery of electrical pulses within this current intensity range enables the desired stimulation of axons in small nerve branches between the two needles (i.e., between the anode and cathode).

[0020] According to one embodiment, the pulse device can be configured to deliver electrical pulses within a frequency range that represents a tolerance range around a 1 Hz frequency value. The advantage of this embodiment is that it allows stimulation frequencies, particularly effective for neurostimulation devices, to be delivered to the ear or earlobe quickly and easily.

[0021] According to another embodiment, the pulse device may have at least one retaining element for securing the pulse device to the ear. The retaining element may also be referred to herein as a mounting rod, a removable mounting rod, or a mounting clip, and simplifies or improves the fastening of the pulse device to the ear.

[0022] According to one implementation, the pulse device (also referred to as a pulse generator) can be rechargeable with electrical energy. In other words, the pulse device can be implemented as rechargeable, especially non-contact rechargeable. The advantage of this is that powering the pulse device can be achieved in a user-friendly and uncomplicated manner.

[0023] According to another embodiment, the pulse device can be configured to be controlled using or capable of using a computing unit. Alternatively or additionally, the control program of the pulse device can be variable. For example, a smartphone can be used as such a computing unit and / or such a control program. Exemplarily only, the pulse device can be unlocked (especially wirelessly) by means of a code (which may be paid for at and / or forwarded via the smartphone) to maintain operation for a certain duration. The computing unit (which may also be referred to as a control unit, control program, or control unit) can, for example, be incorporated either into a pulse-generating device worn near the ear, or, as another possibility, be incorporated into an external device, such as a computer or smartphone, which may be more practical. Such an external device can enable software-based control by the user or medical personnel. Such control can, for example, be used to set the current and / or frequency, and additionally or alternatively, to confirm the stimulation time and / or stimulation frequency. Therefore, the treatment duration can be set via a smartphone, and the device can be turned off at midnight, for example, or set to a lower single-pulse power or a lower pulse frequency, or a longer pulse interval.

[0024] In the case of a software-based computing unit, this can, for example, be combined with various visual displays for treatment modes and / or time settings. Such software-based control can also be used to combine data from neurostimulation devices with biofeedback control of various other medical and / or non-medical measurement devices.

[0025] According to one embodiment, the pulse device can be configured to stimulate at least one auditory nerve in the outer ear and / or the vagus nerve. Auricular electrical stimulation is advantageous for the specific stimulation of the vagus nerve. For this purpose, the needle device can be adjusted in size and shape, for example, to adapt to other areas of the auricle, thereby allowing for targeted stimulation of the vagus nerve.

[0026] According to another embodiment, the pulse device can be configured to be securely fastened behind the auricle. By way of example only, miniaturization of the pulse device allows it to be placed almost imperceptibly behind or within the auricle without causing discomfort. Therefore, comfortable positioning and / or secure retention of the pulse device behind or within the auricle can be achieved. With miniaturization of the pulse device, in the best-case scenario, the user will not even feel that he is wearing the pulse device in his ear.

[0027] Furthermore, an advantageous embodiment of the scheme described herein includes a speaker, particularly one located at or within the needle device and / or at or within the pulse device. This allows the neurostimulation device to be combined with headphones or hearing aids, thereby enabling the neurostimulation device to be used for various other purposes. In another embodiment of the scheme described herein, the pulse device is combined with a speaker and / or supplemented by "in-ear headphones," wherein by adapting the stimulator signal to, for example, the rhythm of music, higher application compliance, greater wearing comfort, or improved efficacy can be achieved.

[0028] The aforementioned advantages can also be achieved as a variation of the method for using the needle device described herein in one embodiment of the scheme described herein, wherein the method includes the step of placing the needle device on the user's auricle and / or earlobe using a handle device.

[0029] A particularly advantageous embodiment of the scheme described here is that it includes a step of separating the handle device (400) at a predetermined break point (600). In this way, the needle device can be efficiently and practically placed on the user's auricle and / or earlobe, wherein the handle device can then be removed again for better user comfort. Attached Figure Description

[0030] Implementations of the submitted solution are shown schematically in the accompanying drawings and described in detail below. Wherein:

[0031] Figure 1 A schematic diagram of one embodiment of a nerve stimulation device having a needle device according to one embodiment is shown;

[0032] Figure 2A schematic diagram of one embodiment of the nerve stimulation device is shown;

[0033] Figure 3 A schematic diagram of one embodiment of the nerve stimulation device is shown;

[0034] Figure 4 A schematic diagram of one embodiment of a nerve stimulation device having a needle device and a handle device according to one embodiment is shown;

[0035] Figure 5 A schematic diagram of one embodiment of a nerve stimulation device having a needle device according to one embodiment is shown;

[0036] Figure 6a A schematic diagram of a needle device and a handle device according to one embodiment is shown for use in a nerve stimulation device;

[0037] Figure 6b A perspective view of a needle device and a handle device according to one embodiment is shown in one embodiment of a nerve stimulation device;

[0038] Figure 6c A schematic diagram of a needle device and a handle device according to one embodiment is shown for use in a nerve stimulation device;

[0039] Figure 6d Four partial schematic diagrams are shown, illustrating a needle device and a handle device according to one embodiment for use in a neurostimulation device.

[0040] Figure 6e Various perspective views of the placement unit for placing the needle device on the ear are shown;

[0041] Figure 7a A schematic partial view of a needle device and a handle device according to one embodiment of a neurostimulation device is shown in the upper portion area, and partial perspective views of a needle device and a handle device according to one embodiment of a neurostimulation device are shown in the middle and lower portions, respectively.

[0042] Figure 7b Two illustrations show possible embodiments of the geometry of the needle;

[0043] Figure 8 A perspective view of one embodiment of the nerve stimulation device is shown;

[0044] Figure 9 Three schematic partial views are shown, each illustrating an embodiment of a nerve stimulation device with a pulsating mechanism;

[0045] Figure 10 A schematic diagram of one embodiment of the nerve stimulation device is shown;

[0046] Figures 11a to 11g Views of one embodiment of the nerve stimulation device are shown respectively;

[0047] Figures 12a to 12g Views of one embodiment of the pulse device are shown respectively;

[0048] Figures 13a to 13g Views of one embodiment of the pulse device are shown respectively; and

[0049] Figures 14a to 14g An embodiment of the neurostimulation device and a perspective view showing the arrangement of the neurostimulation device on the user's head are shown.

[0050] In the following description, the same or similar reference numerals are used for the same or similar elements, wherein, for clarity, repeated explanations of the functions of these elements are omitted. Detailed Implementation

[0051] Figure 1 A schematic diagram of one embodiment of a nerve stimulation device 100 having a needle device 105 is shown. At least one nerve in the auricle where the needle device 105 is placed is electrically stimulated using the nerve stimulation device 100.

[0052] In other words, Figure 1 An illustration shows the positioning of the needle unit after it has been fixed in the ear.

[0053] Various embodiments of this solution may include needle devices of different sizes and / or shapes. Such needle devices may be adapted in shape to specific parts of the auricle, such as the triangular fossa or earlobe. In other words, the shape of the needle device may be adapted to allow it to be placed in the triangular fossa.

[0054] The needle device can also be adjusted in size and shape to be proportionate to or adapted to other areas of the auricle in order to, for example, to specifically stimulate the vagus nerve (i.e., Nervus Vagus).

[0055] Figure 2 A schematic diagram of one embodiment of the nerve stimulation device 100 is shown. The nerve stimulation device 100 is used to electrically stimulate at least one nerve in the auricle where the needle placement device 105 is located.

[0056] Here, a pulse device 200 is coupled to the needle device 105 and generates electrical pulses to the auricle. According to one embodiment, these pulses can be delivered within a current intensity range between 0.05 mA and 1.2 mA. According to an additional embodiment, these pulses can be delivered within a frequency range that represents a tolerance range around an exemplary 1 Hz frequency value. According to one embodiment, the pulse device 200 is electrically rechargeable. Only by way of example can the pulse device 200 be used... Figure 2 The calculation unit (not shown) is used for control. Alternatively or additionally, the pulse device 200 is controlled by... Figure 2 The control program, not shown, can be modified. According to another embodiment, the pulse device 200 can stimulate at least one auditory nerve and / or the vagus nerve in the outer ear. The pulse device 200 includes a retaining element 205, which can be used to secure the pulse device 200 to the ear. Furthermore, the pulse device 200 includes a connection line 210 for connecting the pulse device 200, for example, to the aforementioned computing unit. The pulse device 200 also includes a connection line 215 for connecting the pulse device 200 to the needle device 105. The connection line 215 can alternatively be referred to as a connection portion to a pulse generating device.

[0057] In other words, Figure 2 A visual illustration of the pulse generator and its fastening method on the ear is shown.

[0058] Miniaturization of neurostimulation devices ensures or enables that neurostimulation devices (which may also be referred to as devices for electrical stimulation) can be worn on or near the ear, for example, by wearing the pulse device on or behind the ear and positioning at least one needle in the desired location in the auricle and / or earlobe. The pulse device (which may also be referred to as a pulse generator) can, for example, be equipped with a small handle that ensures or improves the fixation of the device during use.

[0059] According to one embodiment, the pulse device (also referred to as a pulse generator or a detachable pulse generator) can be integrated into a single unit, for example, with a dual-electrode unit. Here, miniaturization, a small battery, rechargeability, and possibly contactless rechargeability are desirable. In this embodiment, it is possible to secure the electrodes from behind the ear. In such embodiments, it is also possible to exemplarily place only one electrode behind the ear, while placing the other in the auricle.

[0060] According to one embodiment, microelectrodes that penetrate the uppermost protective layer of skin can be used. In this embodiment, most of the resistance fluctuations caused by different surface properties (e.g., by skin creams or oils) can be eliminated. Here, for example, one electrode can be placed externally, and a second electrode can be placed behind the ear. The two electrodes can then be connected, for example, using a flexible or spring-loaded clip or retainer.

[0061] According to another embodiment, it is also possible to use multiple electrode pairs simultaneously, for example, to achieve better coverage of nerve branches. An odd number of electrodes can also be used. For example, one conductor may lead to two electrodes, and another conductor may lead to one electrode.

[0062] According to another embodiment, the electrodes can be designed to achieve targeted innervation of specific neural structures (exemplarily, only located in the triangular fossa) in the simplest way. For example, in conjunction with a microprocessor-controlled stimulator, the electrodes can achieve the desired therapeutic effect in treating a variety of different diseases. For example, through a special structural design in which the electrodes are spaced apart from the inner helix and the integrated double needles are spaced two millimeters apart, time-consuming nerve searching can be eliminated, while still ensuring the function of stimulating the correct neural plexus. This special plexus structure is a purely afferent (sensory) neural plexus that converges into the nucleus tractus solitarius via C2 and C3, where, for example, modulation of neurons and synapses can be achieved. The special design of the electrodes ensures, on the one hand, activation of the correct neural structures, and on the other hand, avoids stimulation of nerves that may produce adverse side effects. That is, for example, simple vagus nerve stimulation may lead to a slowing of the heart rate.

[0063] Furthermore, placing the electrodes in the triangular fossa is ideal for long-term treatment. When the electrodes are placed in a largely painless area within a recess of the auricle, application during sleep is possible. For example, the electrodes can be designed to be very small, proportionate to even the smallest triangular fossa with its steep sides. The advantage of this electrode design lies in the overall conception of the electrode shape, which ensures sufficient spacing from the inner side of the helix, thereby guaranteeing the best possible placement of the electrodes within or on the ear.

[0064] The protrusion, constructed as an anchor, is particularly helpful when placing electrodes. This protrusion can be advantageously used as a spacer relative to the auricular arch located below the helix in the triangular fossa, ensuring precise electrode positioning. On the other hand, this protrusion is also very helpful as a fixation aid when placing electrodes.

[0065] This relates to a hybrid electrode in which the aforementioned anchoring protrusion is implemented as a surface electrode. The second electrode (anode-cathode) is implemented as a needle, but should be insulated except for the needle tip.

[0066] The advantage is that the needle causes less pain.

[0067] Figure 3 A schematic diagram of one embodiment of the nerve stimulation device 100 is shown. At least one nerve on the auricle where a needle device 105 is placed is electrically stimulated using the nerve stimulation device 100. Figure 2 The pulse device 200 or similar pulse device described in detail is secured behind the auricle by using a retaining element 205.

[0068] In other words, Figure 3 A visual illustration of the pulse generator and its fastening method on the ear is shown.

[0069] Figure 4 A schematic diagram of one embodiment of a neurostimulation device 100 having a needle device 105 and a handle device 400 is shown. Exemplarily, the needle device 105 can be secured to the auricle using the handle device 400 and an adhesive element 405. Therefore, the handle device 400 can also be referred to as a handle for manipulation, as another possibility.

[0070] In other words, Figure 4 A visual illustration is shown of manipulating a needle unit into a desired location (e.g., a triangular fossa) using an applicator.

[0071] Figure 5 A schematic diagram of one embodiment of a neurostimulation device 100 having a needle device 105 is shown. The needle device 105 can be fixed in a desired location by the user or by a medical professional, such as in the auricle. Figure 4 The handle device shown in the figure can be (subsequently) removed.

[0072] In other words, Figure 5 A visualization is shown showing the needle unit fixed in the desired position followed by the removal of the applicator.

[0073] Figure 6a A schematic diagram of a needle device 105 and a handle device 400 applied in one embodiment of a neurostimulation device 100 is shown. The handle device 400 may alternatively be referred to as a removable handle for guiding the needle device 105 to a desired position.

[0074] According to one embodiment, the needle device 105 can be formed as an electrode needle or a microneedle. According to an additional embodiment, the electrode needle or microneedle can be formed from a biocompatible material, particularly a biocompatible metal.

[0075] Furthermore, the needle device 105 has a predetermined breakage portion 600, which is specifically determined for separating the handle device 400 from the needle device 105.

[0076] According to one embodiment, the shape of the needle device 105 may be adapted to or can be adapted to the application area of ​​the auricle, such as the triangular fossa.

[0077] Figure 6b A perspective view of a needle device 105 and a handle device 400 in one embodiment of a neurostimulation device 100 is shown. According to one embodiment, the needle device 105 may be shaped as a needle element having two needles. According to an additional embodiment, the electrode needles may be spaced 2.0 mm apart and / or have a length of 2.0 mm. For example, a double needle (exemplarily 2 mm between the anode and cathode) and a spacer extension in the form of an anchor can ensure simple but especially correct placement of the electrodes.

[0078] According to another embodiment, the electrode may have one or more biocompatible metals, such as titanium.

[0079] According to one embodiment, the electrode (also referred to as an electrode unit or a self-fixing electrode unit) can be fixed in the desired area by a suitable, if necessary, separable assembly spacer or assembly clip.

[0080] According to another embodiment, a needle element having at least two needles (also referred to as a dual-needle electrode) may be replaced, for example, with two microneedles, one of which may be located in the ear and the other behind the ear. This would allow the stimulation signal to penetrate the skin despite potential differences in skin surface properties and the presence of a subcutaneous fat layer, so that the current transmission resistance remains as similar as possible. The use of short microneedles also minimizes the risk of infection due to a certain skin barrier compared to known solutions (using 2 mm long needles and (then) conducting current through the cartilaginous region covering the nerve). Technically, this can be achieved, for example, by attaching or placing a traction rod, while miniaturized electronic devices could potentially be placed behind the ear.

[0081] Anatomical diagrams of the neural structures in the triangular fossa show that there is a very dense neural plexus at this location, which means that the electrical pulses delivered via the two needles can, under optimal conditions, always or at least very frequently, achieve the desired excitation of axons in the small neural branches between the two needles (i.e., the anode and cathode) with very low current intensity.

[0082] This structural design (also known as a double-needle design) allows patients to ideally not feel any electrical pulses during treatment because the sensitive, point-like nerve endings on the skin surface are sufficiently far apart. This makes it possible to conduct double-blind medical studies, which may be required by regulatory agencies for devices used in minimally invasive stimulation therapies.

[0083] The following examples are intended to provide, to those skilled in the art, as complete and clear as possible disclosure and description of the manufacture of one embodiment of a neurostimulation device, and to illustrate how the neurostimulation device (which may also be referred to as a device for delivering electrical pulses) functions.

[0084] In addition, the needle device 105 has a predetermined breakage portion 600 for separating the handle device 400 from the needle device 105.

[0085] In other words, Figure 6b An illustration shows a combination consisting of a needle unit, a removable handle for operation, and a predetermined break point between the two.

[0086] Figure 6c A schematic diagram of a needle device 105 and a handle device 400 applied in one embodiment of a neurostimulation device 100 is shown. The needle device 105 and a pulse device 200 located behind the auricle are connected to each other via magnetic contacts 605.

[0087] In addition, the needle device 105 has a predetermined breakage portion 600 for separating the handle device 400 from the needle device 105.

[0088] In other words, Figure 6c An illustration shows the positioning of a needle unit with a manipulator handle in the ear. The handle device (alternatively referred to as a guide rod) and its predetermined break point ensure simple and sterile placement of the electrode in or on the ear. Breaking the guide rod makes repeated, potentially non-sterile, use of the needle device virtually impossible.

[0089] in other words, Figure 6cOne method of securing a needle is illustrated. A technical and / or medical challenge that needs to be addressed is the proper securing of the needle in or to the auricle or other area of ​​the ear by the user or medical personnel. According to one embodiment of the neurostimulation device of this solution, this can be achieved by using a needle device of a specific shape (adapted to the shape of the auricular region or earlobe where the needle device is exemplarily to be positioned) and utilizing, for example, a removable handle device (also referred to as a handle). By manipulating the needle device with the handle, the needle can be positioned at the desired location, such as in the auricle. Once this manipulation is completed, the needle can be pressed into the skin and thus secured. The shape of the needle device can be adapted to a specific anatomical region of the auricle to facilitate fixation in a specific region (e.g., in the triangular fossa). Conversely, for positioning and securing on the earlobe, it may be desirable to have a shape and size that are adapted to it if necessary. According to one embodiment, the needle device may be equipped with a... Figure 4 The adhesive element (which may also be referred to as an adhesive connection) shown and described in detail is used to improve fixation. After fixation, the connection between the needle device and the handle device (which may also be referred to as an operating handle) can be disconnected at a predetermined break point. For connection with a pulse device (alternatively referred to as a pulse generating device), the needle device may exemplary include one or more magnetic contacts.

[0090] The needle device may include handle devices of various sizes and shapes (which may also be referred to as detachable handles or applicators), which can be arranged such that the needle device can be easily removed, for example, through a predetermined breakage point, once it has been secured. Furthermore, the needle device may, by way of example, be equipped with a [feature / feature] in front of [the previous / previous / other features]. Figure 4 The adhesive element (alternatively referred to as the adhesive connector) shown and described in detail is used to facilitate fixation. These embodiments of the invention may also include a miniaturized pulse-generating device that can be worn on the ear. Furthermore, the needle device and the pulse-generating device may, for example, include magnetic contacts through which they can be connected to each other.

[0091] In short, these embodiments may include a combination of miniaturized pulse-generating devices and needle devices, which may be connected via magnetic contacts. The needle device may, exemplarily, have a shape adapted to the application area of ​​the auricle and / or include a removable handle for securing it in the ear. Control of the neurostimulation device may be performed, for example, directly through the pulse-generating device (also referred to as a pulse-generating unit) or via software-based external devices such as computers or smartphones. Embodiments of this solution can be used to improve or treat a variety of medical and non-medical conditions, such as relieving muscle tension, peripheral arterial vascular disease, inflammatory conditions, or pain associated with atrial fibrillation.

[0092] Embodiments of this solution may include needle devices of different sizes and shapes, which may be adapted in shape to specific parts of the auricle, such as the triangular fossa, the tail of the helix, the scaphoid fossa, the antitragus, the concha, the antihelix, or the earlobe. These needle devices may, for example, include handle devices of different sizes and shapes (which may also be referred to as detachable handles or applicators). The handle device may be positioned such that, once the needle device is secured, the handle device can be easily removed, for example, by having a predetermined break-off point. Furthermore, the needle device may be included in the preceding... Figure 4 The adhesive element shown and described in detail facilitates fixation. Embodiments of this solution may also include, for example, a miniaturized pulse-generating device that can be worn on the ear. Furthermore, the needle device and / or pulse-generating device may have magnetic contacts, allowing them to connect to each other.

[0093] Figure 6d Four schematic partial views are shown, illustrating the needle device 105 and handle device 400 in one embodiment of the neurostimulation device 100. If we assume that the neurostimulation device 100 is shown from the left in the first partial view from top to bottom, then in the second partial view from top to bottom, the neurostimulation device 100 is shown from above, i.e., rotated 90 degrees compared to the first partial view. In the third partial view from top to bottom, the neurostimulation device 100 is shown from the right, i.e., rotated 90 degrees compared to the second partial view. In the fourth partial view from top to bottom, the neurostimulation device 100 is shown from below, i.e., rotated 90 degrees compared to the third partial view.

[0094] According to one embodiment, the needle device 105 can be formed as a needle element having two needles. Furthermore, the needle device 105 has a predetermined breakage portion 600 for separating the handle device 400 from the needle device 105. The needle device 105 also includes a method for connecting the needle device 105 to the handle device 400. Figure 6d Connection line 215 for pulse devices not specified in the text.

[0095] In other words, Figure 6d These partial illustrations show a combination of a needle unit and a removable handle for manipulation, as well as a predetermined break point between the two, shown more precisely from the sides and from above and below.

[0096] Figure 6eVarious perspective views of a placement device 400 (or synonymously a placement unit) for placing the needle device 105 on the ear are shown. The placement device 400 may be equivalent to, or used as an alternative to, the handle unit 400, and is referred to by the same reference numeral 400 for this reason. However, unlike the handle unit 400, the placement device 400 is not directly connected to the needle device 105, nor is it separated from the needle unit 105 by breaking off the handle unit 400 or the placement unit. Instead, it can be separated from the needle unit 105 by magnetic locking, snap-locking, and / or latching or bayonet locking. The use of the placement unit 400 is particularly advantageous when the needle unit 105 should be placed very precisely and accurately on or in the ear of a patient or general user, because the placement unit, in the form of tweezers or clips, allows for very precise positioning of the needle unit 105 in the desired location in or on the ear, and this positioning can be stably maintained even after the placement unit 400 has been removed.

[0097] Figure 7a A schematic partial view of the needle device 105 and handle device 400 in one embodiment of the nerve stimulation device 100 is shown in the upper part of the region, while partial perspective views of the needle device 105 and handle device 400 in one embodiment of the nerve stimulation device 100 are shown in the middle and lower parts of the region, respectively.

[0098] According to these embodiments, in all three partial views, the needle device 105 can be formed as a needle element having two needles 700. Furthermore, in all three partial views, the needle device 105 has a predetermined breakage portion 600 for separating the handle device 400 from the needle device 105. The needle device 105 also includes a method for connecting the needle device 105 to the... Figure 7a The connecting line 215 connects the pulse device (not shown).

[0099] In other words, Figure 7a A partial illustration shows an assembly consisting of a needle unit, a removable handle for operation, and a predetermined break point between the two. Figure 7a These illustrations illustrate the connection method of the needle 700. In the upper and lower partial views, the needle 700 is arranged outside the needle device 105, respectively. In the middle partial view, the needle 700 is arranged inside the needle device 105.

[0100] Figure 7b Two illustrations show further possible embodiments of the geometry of the needle 700. Figure 7a In the illustration, needle 700 is implemented as a rod or straight, while from Figure 7bAs can be seen, the needle 700 can also be bulging or have a thickened portion in the middle part of the needle 700. Thus, the needle 700 has a larger diameter in the middle than at the ends, so that the thickened portion results in the needle 700 having very good retention after being placed in or on the user's ear.

[0101] Figure 8 A perspective view of one embodiment of a neurostimulation device 100 is shown. The figure shows a needle device 105 and a pulse device 200, which are features of the neurostimulation device 100. The needle device 105 and the pulse device 200 are connected to each other via a connecting line 215 and a magnetic contact 605.

[0102] The pulse device 200 includes a retaining element 205, which can be used to fix the pulse device 200, for example, to the ear. Furthermore, the pulse device 200 includes a connecting line 210 for connecting the pulse device 200, for example, to a computing unit.

[0103] In other words, Figure 8 An illustration shows a device for generating pulses to be placed behind the ear and its magnetic contacts.

[0104] in other words, Figure 8 A magnetic connection between a pulse-generating device and a fixed electrode needle is shown. Traditionally, the connection between the pulse device (also known as a pulse generator) and the needle device can be established, for example, through a small, miniaturized plug-in connector. However, this can be difficult for assistants and hinder user-operated operation. Therefore, the technical challenge lies in achieving a simple connection between the needle device and the pulse device. According to one embodiment, this challenge can be overcome by using, in particular, miniaturized magnetic contacts. The pulse generator may include, for example, a flexible connector with magnetic contacts. This flexible connector can then connect to the magnetic contacts of the needle device. This magnetic connection between the pulse device and the needle device can ensure that the two devices are connected in the correct positioning and orientation, i.e., they can be simply guided to the vicinity of the corresponding other device.

[0105] Figure 9 Three schematic partial views are shown, illustrating embodiments of a neurostimulation device 100 having a pulse device 200. The pulse device 200 includes a holding element 205, which allows the pulse device 200 to be secured, for example, to the ear. Furthermore, the pulse device 200 includes a connection line 210 for connecting the pulse device 200, for example, to a computing unit. The pulse device 200 also includes a magnetic contact 605 for connecting the pulse device 200 to a needle device (not shown). Additionally, the pulse device 200 includes a connection for connecting the pulse device 200 to... Figure 9The connecting line 215 is connected to the needle device (not shown).

[0106] In other words, Figure 9 The partial illustration shows a device with magnetic contacts for generating pulses, to be placed behind the ear.

[0107] Figure 10 A schematic diagram of one embodiment of the nerve stimulation device 100 is shown. At least one nerve on the auricle, on which a needle device 105 is placed, is electrically stimulated using the nerve stimulation device 100. A pulse device 200 is secured behind the auricle using a retaining element 205. The needle device 105 and the pulse device 200 are connected to each other via a connecting line 215 and a magnetic contact 605.

[0108] In other words, Figure 10 A visual illustration of the magnetic connection between two units is shown. The connector of this structural assembly can be guided to the vicinity of a pre-positioned needle. Two built-in magnets help to find the final positioning.

[0109] According to one embodiment, this solution represents a miniaturized device for stimulating the auditory nerve, having a manipulator handle for needle fixation and a magnetic connection between the needle unit and the pulse-generating device.

[0110] It is conceivable that the neurostimulation device described herein could be integrated into a hearing aid or headphones. Therefore, not explicitly shown in the accompanying drawings, the neurostimulation device may have at least one speaker, through which sound or sound waves are output to the ear of the user using the neurostimulation device. Such an embodiment has the advantage of continuing to use known items to obtain additional benefits, thereby significantly improving user comfort. Here, the neurostimulation device formed by such a hearing aid or corresponding headphones can operate, for example, in three modes: as a pure speaker (and possibly also as a hearing aid), as a pure stimulator (e.g., at night when there is sound interference), or in a combined mode, wherein the electrical pulses may follow a specific beat, or may be adapted to the beat frequency of music, i.e., by speeding up or slowing down such a beat of the electrical pulses.

[0111] According to this solution, the aforementioned technical challenges, particularly the challenge of correctly positioning the needle in the region of the auricle or earlobe, can be ideally overcome or improved through the appropriate miniaturization of the pulse device (alternatively referred to as a pulse-generating device), especially in combination with a needle application device that enables the user to apply the needle to a preset location on the ear. Furthermore, this solution provides a simple connection between the pulse-generating device and, for example, a fixed needle via magnetic contacts (also referred to as magnetic connectors), thereby largely avoiding potentially complex connection operations performed by the user or an assistant. Therefore, embodiments of the device implemented according to this solution enable self-operation by the user, allowing these devices to be used in home care. Simultaneously, miniaturization and simplified operation (particularly for needle positioning, fixation, and connection to the pulse-generating device) are also advantageous for use in clinical settings.

[0112] Traditional neurostimulation devices are capable of delivering electrical energy to the auricle region. The presently disclosed solution relates to a neurostimulation device for electrically stimulating the auricle. This neurostimulation device can be used, for example, to improve or treat a range of medical and non-medical conditions. In particular, the presently disclosed solution relates to a combination of miniaturized pulse-generating devices and needle units, which can be connected via magnetic contacts, exemplarily only. According to one embodiment, the needle unit may include a removable handle for fixation in the ear. Embodiments of the neurostimulation device can be used, for example, to relieve muscle tension, in peripheral arterial vascular disease, in inflammatory states, or in atrial fibrillation to reduce pain.

[0113] In other words, the disclosed scheme relates to an electrical and / or neural stimulation device. In particular, the disclosed scheme relates to a device for electrically stimulating the auricle and / or earlobe. This device can be used to improve or treat a range of medical and non-medical conditions.

[0114] Besides specific stimulation of the vagus nerve or other nerves, auricular electrical stimulation can be used for both medical and non-medical purposes. The nerves in the outer ear are typically purely afferent (sensory) in origin. This means that impulses are directed entirely or almost entirely to the brainstem. Traditionally, it has been considered irrelevant which nerves in the outer ear are stimulated, as these nerves normally all interface with the nucleus tractus solitarius, the neurogustatory nucleus. However, stimulation close to the nerves is important because typically only mild stimulation activates axons for impulse conduction. It should be noted that surface stimulation is generally not suitable for prolonged stimulation because nerve endings quickly become refractory. The triangular fossa, i.e., the outer ear, may be an ideal location for such stimulation because a dense plexus of the greater auricular nerve is typically present in the area of ​​the triangular fossa. Furthermore, the depression of the triangular fossa facilitates the application of objects. The triangular fossa typically contains a dense plexus of nerves.

[0115] Another aspect of the mechanism of action may be related to the mode of stimulation. It is important to remember that in cases of nerve overstimulation (such as overstimulation in spinal cord stimulation), stimulation conduction may be blocked, and nerve conduction may become refractory. This can be successfully used for pain blockade in pain management. In contrast, in "low-level nerve stimulation" of the auricle, afferent nerves can act as carriers of excitation potentials to the brainstem. Thus, regulatory processes in the brainstem can be stimulated, for example. Under continuous intermittent stimulation, this can lead to the modulation of neurons and / or synapses, and thus to improvements in important regulatory mechanisms. The application of TENS (e.g., in pain management) is usually performed by the patient or user themselves, while the application of PENS is generally more often performed by medical personnel and / or experienced individuals.

[0116] Figure 11a A perspective view of a neurostimulation device 100 according to an embodiment of the scheme described herein is shown. It can be seen that the pulse device 200 is coupled to the needle device 105 via a connecting line 215. It should be noted that solid lines depict parts of the neurostimulation device 100 that are important for the function or use of the neurostimulation device 100 described herein, while dashed lines indicate parts that are less important for the function of the scheme described herein. Nevertheless, it should be noted that not all elements shown in solid lines are essential for the function of the scheme described herein.

[0117] Figure 11b A front view of a neurostimulation device 100 according to an embodiment of the scheme described herein is shown. Again, the pulse device 200 can be seen, which is connected to the needle device 105 via a connection line 215, the needle device 105 itself being housed by a handle or handle device 400 for better placement on the user's ear.

[0118] Figure 11c A rear view of one embodiment of the neurostimulation device 100 is shown, in which the elements mentioned in the foregoing sub-figures and paragraph 11 are also drawn again.

[0119] Figure 11d A left-side view of one embodiment of the neurostimulation device 100 is shown from the left.

[0120] Figure 11e A right-side view of one embodiment of the neurostimulation device 100 is shown on the right.

[0121] Figure 11f A top view of one embodiment of the nerve stimulation device 100 is shown.

[0122] Figure 11gA bottom view of one embodiment of the neurostimulation device 100 is shown below.

[0123] As can be seen in the various diagrams of Figure 11, the pulse device 200 is flexibly connected to the needle device 105 via the connecting line 215, wherein the needle device 105 is held by the handle device 400 for better positioning. It is also conceivable that the needle device 105 can be separated from the connecting line 215 and / or the pulse unit 200, for example, to better position the various components of the neurostimulation device 100, and then, for example, these two components can be reconnected to each other. In this way, comfortable placement of the various components of the neurostimulation device 100 can be achieved. It is also conceivable that the various components can be coupled to each other, for example, by means of magnets, thereby achieving secure holding of the neurostimulation device 100 on the user and minimizing damage to the user's body parts caused by placing the neurostimulation device 100.

[0124] Figure 12a A perspective view of one embodiment of the pulse device 200 is shown. It can be seen that the pulse device 200 can be designed to be curved or C-shaped, so as to be particularly advantageously positioned, for example, behind the ear of the user of the neurostimulation device. In this way, the user's use of the neurostimulation device is also less conspicuous, because in this case, the pulse device 200 is, for example, partially obscured by the user's ear, either the pulse device 200 or a part of the neurostimulation device (of which the pulse device is a component).

[0125] Figure 12b A front view of one embodiment of the pulse device 200 is shown.

[0126] Figure 12c A rear view of one embodiment of the pulse device 200 is shown.

[0127] Figure 12d A left-side view of one embodiment of the pulse device 200 is shown from the left. Various different connections 1200 or switches can be seen here, which are arranged in the connection area 1210 of the pulse device 200, and whose functions can be controlled by means of, for example, these connections or switches.

[0128] Figure 12e A right-side view of one embodiment of the pulse device 200 is shown on the right.

[0129] Figure 12f A top view of one embodiment of the pulse device 200 is shown.

[0130] Figure 12g A bottom view of one embodiment of the pulse device 200 is shown.

[0131] Figure 13a An embodiment of a handle device 400 is shown, which has a needle device 105 fastened thereto. It can be seen here that the handle device 400 covers the area of ​​the needle device 105 in order to enable more accurate or simpler positioning of the needle device 105 on the ear of the user of the neurostimulation device of the scheme described herein.

[0132] Figure 13b A front view of one embodiment of the handle device 400 is shown, which has a needle device 105 fastened thereon.

[0133] Figure 13c A rear view of one embodiment of the handle device 400 is shown from the rear side, which has a needle device 105 fastened thereto.

[0134] Figure 13d A left-side view of one embodiment of the handle device 400 is shown from the left, which has a needle device 105 disposed thereon.

[0135] Figure 13e A right-side view of one embodiment of the handle device 400 is shown from the right side, which has a needle device 105 disposed thereon.

[0136] Figure 13f A top view of one embodiment of the handle device 400 is shown above, which has a needle device 105 disposed thereon.

[0137] Figure 13g A bottom view of one embodiment of the handle device 400 is shown below, which has a needle device 105 disposed thereon.

[0138] Figure 14a A perspective view of a neurostimulation device 100 according to one embodiment is shown. In this neurostimulation device 100, a headband 1400 is also exemplarily provided, which includes, for example, magnets 1410 that can be coupled to a corresponding pulse device 200 (in... Figure 14a The synergistic effect of magnets (not shown) allows the pulse device 200 to be securely fixed, for example, at a desired location on the head of the user of the neurostimulation device 100.

[0139] Figure 14b An exploded view of one embodiment of the neurostimulation device 100 is shown, in which it can now be seen how the head patch 1400 can be secured to the head 1420 of the user of the neurostimulation device 100 at or behind the ear.

[0140] Figure 14c Now, another feasible solution for placing or securing the headband 1400 to the user's head 1420 is shown from another perspective.

[0141] Figure 14d A perspective view of one embodiment of the nerve stimulation device 100 is shown.

[0142] Figure 14e A further perspective view of a pulse device 200 is shown, which can be used as part of a neurostimulation device 100 according to one embodiment described herein.

[0143] Figure 14f A perspective view of another embodiment of the nerve stimulation device 100 is shown.

[0144] Figure 14g A perspective view of another embodiment of the nerve stimulation device 100 is shown.

[0145] Furthermore, the existing application experience of the schemes presented here can be listed in more detail. As is known, the human brainstem is a regulatory center that needs information from the whole body, as well as from areas such as thinking, vision, hearing, and sensation, in order to cope with all changes. The novelty of this hypothesis lies in the fact that, for example, aging, certain chronic diseases, or certain mental stress can cause the demand from the periphery to become too low, and after a period of time this becomes the norm for the brainstem and can no longer be regulated. Importantly, when stimulation originates from a certain area, such as while walking, during any physical activity, or while speaking, the sensory function of the receptors in the brainstem will be improved.

[0146] Stimulation in the form of exercise, running training, and muscle training has a dual effect: the body is trained, and the receptors in the brainstem are also improved.

[0147] Excessive and overly strong sensory impulses can cause sensory refractory periods and block impulses reaching receptors in the brainstem. This acts as a form of protection for the brainstem. For example, we allow excessive advertising information to pass through.

[0148] The vagus nerve is 80% afferent and transmits information from the entire trunk to the brainstem.

[0149] The efferent portion of the vagus nerve transmits instructions either to the sympathetic or parasympathetic nervous system, allowing it to regulate blood flow and all inflammation throughout the body (i.e., cytokine regulation).

[0150] The entire outer ear contains only sensory nerves, but in the triangular fossa region, the nerve structure is so dense that the double-needle or needle device 105 using the scheme described herein will not miss the nerves. For example, acupuncturists can also use it because they always target the nerves. However, nerve endings are very sensitive, and the stimulation is blocked after a short time.

[0151] Using the dual-needle or needle device 105 described herein, neural structures can be stimulated more deeply and at very low intensity and frequency with intermittent stimulation. In this way, the receptors in the brainstem can be trained continuously day and night. It should be considered that a well-functioning brainstem cannot repair problematic conditions. Even a well-trained brainstem can only reach its maximum potential. The body requires external assistance.

[0152] It can be pointed out that brainstem stimulation, or sensory vagus nerve stimulation (this is a matter of nomenclature), consistently helps train the receptors. Every type of inflammation can cause pain. Normally, the brainstem receives the relevant information and repairs these inflammations. However, in chronic pain, the brainstem perceives it as normal and does not repair it. Using the neurostimulators described here, for example in the case of spinal cord tumors, can achieve above-average success rates.

[0153] Electrical stimulation of the brain's intelligence can increase the number of neurons and synapses. This demonstrates the brain's plasticity. At this point, the brain typically needs information, both from the body and as memories for regulation. It requires sensory pathways.

[0154] It will stop adjusting when it has less information. This can happen in the following situations: - PAD - Peripheral Artery Occlusive Disease - The small arteries' job is to transport blood to all parts of the body. Fluids like blood travel only the shortest path and do not diffuse on their own. Small arteries and veins, on the other hand, pump blood to all parts of the body. For this, our regulatory center (brainstem) needs to receive information.

[0155] As arterial calcification worsens, less blood flows to the extremities. Nerves weaken. Over time, the brainstem perceives this as normal and reduces its activity.

[0156] When major blood vessels cannot be treated, walking is the only way to send signals to the brainstem. Many people experience pain while walking.

[0157] The stimulator described here can enhance the perception of the human brainstem at a lower stimulation level, enabling the brainstem to recognize lower requests from the extremities. It will then re-initiate vasomotor activity.

[0158] Increased blood flow can sometimes be measured an hour later.

[0159] The conclusion drawn from this is that training sensory pathways through intellectual stimulation is feasible. Lower power levels and intervals are important; otherwise, the system becomes refractory. With age, this stimulation acts like a fountain of youth.

[0160] In principle, the sensory abilities of the human brainstem are always beneficial.

[0161] However, the methods described here will be ineffective if the brainstem is unable to repair the problem. If the arterioles and venules are excessively calcified and lose their elasticity, the brainstem will be unable or insufficient to eliminate the calcification.

[0162] If the peripheral nerves are almost completely destroyed, the brainstem cannot revive them. In such cases, only one attempt is possible. This can, for example, prevent one-third of amputations due to severe ischemia.

[0163] Another key aspect of the mechanism of action described here is the regulation of cytokines. Stimulation will further enhance sensory abilities in the brainstem, and better regulation of cytokines will reduce inflammation and alleviate pain.

[0164] Headaches are a common ailment, but their causes are often unknown. If the cause is unclear, stimulation therapy may be attempted. For this, sensory function should be trained. This typically means treatment lasting up to three weeks. Treatment should continue for more than three weeks because inflammation takes approximately three weeks to heal. If the cause is muscle tension, stretching exercises should be used to aid in successful treatment. Communication between the brainstem and peripheral information should always be possible. The importance of sensory perception is demonstrated, for example, in the vagus nerve. The vagus nerve has 80% afferent pathways and only 20% efferent pathways. However, the regulatory center is always the brainstem, not the vagus nerve.

[0165] Overall, it can be noted that various types of stimulation therapy have been experienced since 2004. In some cases, great success has been achieved, while in others, less effective or no effect has been observed.

[0166] Based on these experiences, the following hypothesis is proposed: the human brainstem is the regulatory center for all changes; it needs information from the whole body, as well as from thought, vision, hearing, and sensation. The novelty of this hypothesis lies in the fact that with age, chronic illness, or mental stress, the demand from the periphery becomes too low, and after a period of time, this becomes the norm for the brainstem, to the point that the brainstem no longer regulates. Importantly, stimulation originates from a specific location, such as during walking, exercise, or speaking, thereby improving the sensory function of receptors in the brainstem. Stimulation in the form of exercise, running, or muscle training has a dual effect: the body is trained, and the receptors in the brainstem are also improved. Too many and too strong sensory impulses cause sensory function to become refractory and block impulses reaching the receptors in the brainstem. This acts as a kind of protection for the brainstem. For example, when we hear too many advertisements, we let them pass by. The vagus nerve is 80% afferent, carrying information from the entire trunk to the brainstem. The efferent portion of the vagus nerve transmits instructions either to the sympathetic or parasympathetic nervous system.

[0167] The entire outer ear contains only sensory nerves, and the nerve structure is so dense in the triangular fossa region that the double-needle or needle device 105 using the method described here will not miss the nerves. Ear acupuncturists also use this method because they always target the nerves. However, nerve endings are very sensitive, and the stimulation is blocked after a short time. Using the double-needle or needle device 105 using the method described here, nerve structures can be stimulated more deeply and at a very low intensity and frequency with intermittent stimulation. This continuously trains the receptors in the brainstem day and night. It should be considered that if a well-functioning brainstem cannot repair the problem, then an underdeveloped brainstem will only reach its maximum. The body needs external assistance. It can be said that brainstem stimulation or sensory vagus nerve stimulation (this is a matter of nomenclature) always helps train the receptors. Every type of inflammation can cause pain. Normally, the brainstem receives the relevant information and repairs these inflammations. However, in chronic pain, the brainstem treats it as normal and does not repair it.

[0168] Furthermore, the approach described here can also be applied to the field of cervical and low backpain. One study yielded excellent results in this area, but its title included the word "acupuncture," which is not accepted in scientific medicine, especially since it was not a double-blind study.

[0169] The conclusion that can now be drawn is that electrical stimulation of the brain's intelligence can increase the number of neurons and synapses. Therefore, the scheme presented here demonstrates the brain's plasticity. The most important insight derived from this is that the brain or brainstem always needs information from our body as a means of regulating memory. The brain / brainstem requires sensory pathways. When the brain / brainstem receives less information, it will downregulate its regulation.

[0170] It's important to note that fluids like blood only travel the shortest path to spread throughout the body. Small arteries and veins pump blood to all parts of the body. For this, our regulatory center (the brainstem) needs to receive information. As arterial calcification worsens, blood flow to the periphery decreases. Nerves weaken. Over time, the brainstem perceives this as normal and reduces its activity. A vicious cycle begins.

[0171] When major blood vessels cannot be treated, walking is the only viable option for sending signals to the brainstem. Many people experience pain while walking. The stimulator described here can enhance perception in our brainstem through weak stimulation, enabling the brainstem to recognize requests from lower peripheral nerves. The brainstem will then reactivate vasomotor activity. Increased blood flow can sometimes be measured an hour later.

[0172] Another conclusion is that it is feasible to train sensory pathways through intelligent stimulation. Less current and more intermittent stimulation are important; otherwise, the system becomes refractory. This stimulation acts like a fountain of youth as we age. Fundamentally, the sensory capabilities of our brainstem will always be beneficial.

Claims

1. Needle device (105) configured for being placed or placeable on the auricle and / or the earlobe, wherein, The needle device (105) has a handle device (400) and / or a placement unit (400) for placing the needle device (105) on the auricle and / or the earlobe.

2. The needle device (105) according to claim 1, wherein, The needle device (105) has a predetermined breaking point (600) for separating the handle device (400) from the needle device (105), and / or wherein the placement device (400) of the needle device (105) is configured as a forceps and / or a clamp, and / or wherein the placement device (400) of the needle device (105) has a click-lock element and / or a snap-lock element and / or a magnetic-lock element for non-destructive separation of the needle (700) of the needle device (105) from the placement device (400).

3. The needle device (105) according to any of the preceding claims, wherein, The needle device (105) is detachably connected or connectable to a pulse device (200) by means of at least one magnetic force contact (605), wherein the pulse device (200) is coupled or couplable to the needle device (105) for emitting at least one electrical pulse to the auricle and / or the earlobe, and / or wherein the needle device (105) is detachably connected or connectable to the pulse device (200) by means of at least one clamp or forceps.

4. The needle device (105) according to any of the preceding claims, wherein, The needle device (105) is shaped as at least one electrode needle and / or at least one microneedle and / or a needle element having at least two needles, in particular wherein the at least one electrode needle and / or the at least one microneedle is shaped from a biocompatible material, in particular a biocompatible metal.

5. The needle device (105) according to any of the preceding claims, wherein, The needle device (105) has at least one adhesive element (405) for fastening the needle device (105) on the auricle and / or the earlobe.

6. A nerve stimulation device (100) for electrically stimulating at least one nerve of at least one auricle and / or at least one earlobe, wherein The nerve stimulation apparatus (100) has the following features: - a needle device (105) according to any one of claims 1 to 6; and - a pulse device (200) for generating electrical pulses, which is detachable from the needle device (105), wherein the pulse device (200) is coupled or couplable to the needle device (105) for emitting at least one electrical pulse to the auricle and / or the earlobe.

7. The nerve stimulation device (100) according to claim 6, wherein The pulse device (200) is configured for emitting electrical pulses in a current intensity range of between 0.05 milliampere and 1.2 milliampere.

8. The neurostimulation device (100) according to any of the preceding claims 6 or 7, wherein, The pulse device (200) is configured for emitting electrical pulses in a tolerance range around a frequency value of 1 hertz.

9. The neurostimulation device (100) according to any of the preceding claims 6 to 8, wherein, The pulse device (200) has at least one holding element (205, 210) for fixing the pulse device (200) on the ear.

10. The neurostimulation device (100) according to any of the preceding claims 6 to 9, wherein, The pulse device (200) is rechargeable with electrical energy.

11. The neurostimulation device (100) according to any of the preceding claims 6 to 10, wherein, The pulse device (200) is configured to be controlled using or using a computing unit, and / or wherein a control program of the pulse device (200) is changeable.

12. The neurostimulation device (100) according to any of the preceding claims 6 to 11, wherein, The pulse device (200) is configured for implementing a stimulation of at least one auricular nerve at the outer ear and / or a stimulation of the vagus nerve.

13. The neurostimulation device (100) according to any of the preceding claims 6 to 12, wherein The pulse device (200) is configured for fastening behind the auricle, and / or wherein The neurostimulation device (100) is additionally equipped with a speaker, particularly wherein the speaker is disposed on or in the needle device (105), and / or disposed on or in the pulse device (200), and / or wherein the neurostimulation device (100) is additionally equipped with a speaker and / or supplemented by an earphone disposed in the ear.

14. Method for using a needle device (105) according to any of the preceding claims 1 to 6, wherein, The method comprises the following steps: - The needle device (105) is placed on the user's auricle and / or earlobe using the handle device (400).

15. The method according to claim 14, the method comprising the step of separating the handle device (400) at a predetermined fracture site (600).

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