TRAINING STIMULATION OF NERVE CELL ENDS

Description

[0001] The invention relates to a training device for stimulating nerve cell ends, a method for operating a training device, the use of a training device for stimulating nerve cell ends, and the use of a training device in a prosthesis according to the preambles of the independent claims.

[0002] On June 8, 2015, the Austrian daily newspaper derStandard.at published an article under Science > Human about a development by Professor Hubert Egger, one of the world's leading prosthetics researchers. The article reports on the first leg prosthesis that "feels" like a human. It details how, in a patient with a leg amputation, severed nerves were reactivated and relocated to a specific area of ​​skin on the stump. Because this area of ​​skin then contains the reinnervated nerve endings, it becomes particularly sensitive. The nerve endings were relocated in such a way that the former foot, with its physionomy-typical nerve segments, was replicated in this skin area. In other words, a physionomy-typical nerve segment is a natural nerve segment that is relocated to the surface of a skin area not typically found there.The patient therefore did not (only) feel the skin (surface) in this area of ​​skin as usual, but rather the reinnervated nerve cell endings and thus, in effect, his sole of the foot, which is no longer present as a result of the amputation of the extremity.

[0003] The prosthesis used in the presented solution was designed in such a way that the stimulators are fixed in the shaft of the prosthesis, so that stimulation of the nerve cell ends is only possible after the individual, orthoptic adjustment of the prosthesis shaft to the patient.

[0004] US patent 2014 / 0277583 A1 discloses a system for a neurally activated limb prosthesis. The system comprises an instrumented prosthesis with sensors that are connected via an interface system to a stimulation system for digitizing and assigning the sensor values. The interface system includes a stimulator that interacts with an electrode located within the limb.

[0005] A disadvantage of this known system is that an electrode positioned within the limb is necessary to stimulate a nerve within the limb. Furthermore, this system necessarily includes a prosthesis to transmit sensor values ​​from the prosthesis to a nerve, making it unsuitable as a training device as described here.

[0006] US patent 2008 / 0077192 A1 discloses a device and a method for neurostimulation. The device has stimulation electrodes for stimulating naturally occurring nerve cells. The stimulation is transmitted from the stimulation electrodes to a contact surface of the device housing. This results in large-area stimulation of the body surface.

[0007] A disadvantage of this known solution is that the stimulation electrodes do not touch the patient's body and are therefore not designed to stimulate individual nerve cell endings assigned to them.

[0008] US patent 2003 / 0144710 A1 shows a device of a similar type. None of the previously mentioned devices show a training device for stimulating nerve cell endings.

[0009] The object of the present invention is to overcome one or more disadvantages of the prior art. A known phenomenon is that reinnervated nerve cell endings—since they are located in an area that is foreign to them—take a relatively long time to become fully responsive. In particular, a training device for the stimulating training of nerve cell endings is to be created, with which it is possible, postoperatively, to train a natural movement of a missing limb at the patient's nerve cell endings in a realistic way. This should help to restore the full functionality of the affected nerve cell endings as quickly as possible, especially through nerve cell growth (cell division at the synapses).Furthermore, a method for operating a training device, a prosthesis for using this training device, a method for manufacturing this prosthesis, the use of the training device for training stimulation, and the use of the training device in a prosthesis for another purpose are to be provided. This is intended to overcome one or more disadvantages of the prior art and to better ensure the desired purpose, namely the stimulation of growth or improvement of the sensitivity of nerve cell endings.

[0010] The problem is solved by the features of the independent claims. Advantageous developments are set out in the figures, the associated description, and the dependent claims.

[0011] The training device according to the invention for the training stimulation of nerve cell endings comprises a housing with at least one first housing section and with several stimulators for stimulating physionomy-typical nerve area sections. Several stimulators are systematically arranged at least on the first housing section of the housing, wherein several housing openings are provided on the first housing section in which the several stimulators are arranged section by section, so that the several stimulators act on the nerve cell endings assigned to them in the training state.

[0012] The systematic arrangement depends on the actual location of the respective relevant nerve cell endings on the postoperatively provided, physionomically typical nerve area segment, so that a sequential response of each of the multiple stimulators generates the sensation of genuine stimulation along the actual or natural skin area of ​​the missing limb and is perceived as such in the brain. When the multiple stimulators act on their assigned nerve cell endings, stimulation signals are transmitted from the stimulators to the nerve cell endings. This trains the nerve cell endings as early as possible, thus minimizing the patient's adaptation phase to a later prosthesis.

[0013] Stimulation here always includes the transmission of information, although typically no energy transfer takes place from the training device to the patient.

[0014] With the training device according to the invention, the sensation of walking with the patient's (former) foot can be simulated immediately after surgery. This training device makes it possible to stimulate the postoperative growth of the physionomy-typical nerve segments or nerve cell endings, thus achieving a timely and optimal provision of a suitable skin area on the remaining part of the patient's limb. In other words, the training device serves to more successfully reinnervate nerve cell endings for the purpose of later adapting the remaining part of the limb to a prosthesis.

[0015] In particular, the training device can be used to stimulate reinnervated nerve cell ends, with the reinnervated nerve cell ends of a foot being particularly trainable.

[0016] Preferably, the systematic arrangement of the multiple stimulators replicates the gait pattern of a human foot. The stimulators are arranged according to a matrix, for example, in a lightning bolt pattern. For instance, at least five stimulators are required in the first housing section, which allows for a particularly accurate representation of the gait pattern of the human foot. The systematic arrangement of the multiple stimulators is such that each stimulator is positioned at least at one associated, physionomically typical nerve cell end, which, in an intact foot, is or would be connected to the respective nerve cell ends along the natural gait pattern of the foot.

[0017] Preferably, several stimulators, in particular two stimulators, are arranged in the area of ​​each physionomy-typical nerve cell end, thereby improving the stimulation resolution.

[0018] The multiple stimulators are advantageously arranged on the training device and can be individually adjusted. The spatial position of a first stimulator relative to at least one of the other stimulators can be adjusted. The stimulators can be arranged along a first longitudinal axis on the first housing section and adjusted accordingly. Alternatively or additionally, the stimulators can be arranged to rotate around a mounting section. This allows at least some of the multiple stimulators to be individually adjusted to specific nerve endings, further improving the training of these nerve endings.

[0019] In particular, according to a specific embodiment of the invention, these two stimulators can be configured differently so that different stimulations or stimulation signals are delivered to the extremity or foot at the respective location. For example, the signal from the first stimulator can indicate the fact of touch, while the signal from the second stimulator is only activated above a certain simulated pressure intensity of touch, thus enabling the delivery of both qualitative and quantitative information.

[0020] The natural gait pattern of a foot is usually determined during a gait analysis at a suitable measuring station. The kinematics and kinetics of the gait are measured and plotted along a line on the sole of the foot. Typically, a natural gait pattern runs largely along the longitudinal axis of the sole.

[0021] Depending on the individual anatomy of the foot, each foot can exhibit several distinct natural gait patterns, which are often defined as a single natural gait pattern. For example, the natural gait patterns of a healthy foot differ from those of an artificial foot on the same patient in terms of their width, or the single gait pattern of a wearer of a transfemoral prosthesis differs from the single gait pattern of a wearer of a transfemoral prosthesis. Therefore, the training device described here allows for the individual training of gait patterns or single gait patterns tailored to the patient.

[0022] Advantageously, the stimulators feature stimulation isolation made of an elastic material, such as rubber, at least in some sections. This stimulation isolation prevents the stimulators from interacting with the housing section in a way that transmits sound. This allows for additional sound decoupling from the housing of the training device.

[0023] The key factor is where the artificial foot sole corresponds to the gait pattern when used as intended. The multiple stimulators on the training device create a representation of the gait pattern by being positioned at the locations corresponding to the relevant nerve endings. The reinnervated nerve endings at the physionomy-typical nerve endings can also be arranged according to a representation of the gait pattern, although this is not strictly necessary. The crucial element is simply the correct assignment of stimulators to nerve endings.

[0024] Preferably, a control unit for controlling multiple stimulators is provided, which includes at least one training program. This allows the multiple stimulators connected to the control unit to be activated according to a predefined program sequence, so that the nerve cell endings can be trained individually and collectively in a targeted and reproducible manner.

[0025] Preferably, the control unit is coupled with a visualization device to visually present the patient with a training stimulus from at least one training program. This means that during the training of the nerve cell endings, not only are the tactile sensory perceptions in the area of ​​the physionomy-typical nerve region stimulated, but also the visual receptors in the human eye, thereby improving overall perception and processing in the human brain. According to one of the considerations underlying the invention, the training can be supported by supplying the brain with the same information via other sensory channels. For example, by visually representing where (of the "depicted" foot) the respective training stimulus is delivered.

[0026] Alternatively or additionally, messages, such as instructions from a third party, for example a doctor, can be displayed to the patient on the visualization device.

[0027] A single training program, as understood here, primarily refers to a training program that includes training data or training commands for specific movement sequences, such as running, jumping, or climbing movements. Alternatively, for example—in the case of reinnervation of finger nerves for a human hand—a grasping movement could be executed as a training program using the control device.

[0028] Preferably, the control unit is arranged in the housing, which allows for a compact design of the training device.

[0029] Preferably, the control unit can be operated with an external remote device, such as a remote control or a computer. The remote device can be connected to the interface of the training device using a data cable. This allows the user to control the training device, which is located in a hard-to-reach area of ​​the body.

[0030] In particular, the control unit can be operated with a mobile device, such as a smartphone or tablet. The mobile device has an application that connects to the training device for data exchange. This eliminates the need for an additional device and allows the user to control the training device with a familiar device.

[0031] Preferably, the training device includes a data transmission device for transferring data. For example, the user can transmit messages, as data, to the training device, which can then be displayed on the visualization device.

[0032] Preferably, the data transmission device is located in the control unit so that external training data can be transferred to the control unit. This allows any authorized user to adapt existing training data to the training device or transfer new training programs to the training device.

[0033] The term "user" here refers to a patient, a physiotherapist, and / or an orthopedist.

[0034] Alternatively or additionally, stimulation data may be transmitted to the control unit via the data transmission device. Stimulation data, or stimulation commands, are understood to be those data that can individually stimulate individual reinnervated nerve cell endings. This allows nerve cell endings with varying sensitivities within the physionomy-typical nerve area segment to be trained to a uniformly high level of sensitivity.

[0035] Preferably, the data transmission device includes a transmitter and a receiver for wireless data exchange. Typically, the data transmission device incorporates a WLAN unit or a Bluetooth® connection, allowing training and stimulation data to be easily transferred to the control unit.

[0036] Preferably, the data transmission device includes an interface on which a user can define training programs. Typically, an input device, such as a keyboard, can be connected to the interface, making the training programs easily adaptable.

[0037] Alternatively or additionally, a user can define training programs and stimulation programs at the interface. Stimulation programs comprise stimulation commands or stimulation data for stimulating individual nerve cell endings, which can therefore be adapted individually. For example, training programs and stimulation programs can thus be adapted synchronously.

[0038] In particular, the interface includes an input device for entering stimulation data, training data, or sensor data. In addition to a main switch (on / off switch), the input device includes a selection switch for choosing predefined training programs and / or stimulation programs. This simplifies the activation of the training device and / or the selection of training programs and / or stimulation programs for the user.

[0039] Preferably, the input device is arranged at the visualization device, thereby improving the haptics of the training device for the user.

[0040] In particular, the input device is integrated into the visualization unit as a touchscreen. This allows for the creation of a particularly lightweight training device.

[0041] Preferably, the data transmission device can be supplied with external sensor data from a prosthesis. External sensor data is transmitted to the data transmission device and used in the associated control unit to control the multiple stimulators. For example, external sensor data, such as pressure sensor data, can be sent from a prosthetic component, preferably an artificial foot sole, to the data transmission device and then transmitted to the multiple stimulators.

[0042] Alternatively or additionally, the data transmission device can be connected to several external sensors. This allows for the integration of data not only from the prosthesis itself, but also from external sensors such as temperature, humidity, and GPS. This data, combined with the prosthesis's sensor data, can be used to train the nerve endings. For example, GPS data can be used to track the prosthesis user's location and combined with a training program within the device. This allows training programs such as "mountain climbing," "running," or even "dancing" to be linked to the prosthesis user's current or desired location(s).

[0043] Preferably, the data transmission device is connected to a cloud within a network for data exchange, whereby the data can be external sensor data, external training data, or external stimulation data. This allows the user access to historical data stored in the cloud. Using this historical data can, for example, shorten or improve maintenance work or service applications on the training device.

[0044] Preferably, the data transmission device is connected to an online data exchange service, which makes it easy to assign user access rights.

[0045] Preferably, the data is stored using blockchain technology, which ensures that the data is stored with particularly good encryption, so that no sensitive or personal data of the user can be published.

[0046] Preferably, the control unit includes a processing unit, wherein the processing unit has at least one stimulation program for creating stimulation commands for a stimulation state. This allows individual stimulation commands to be created in the control unit.

[0047] Alternatively or additionally, the processing unit includes at least one training program for creating training commands for a training process. This allows individual training commands, as well as individual stimulation commands, to be created and combined within the control unit.

[0048] Preferably, the computing unit is connected to the data transmission device for exchanging data, making it possible to create new stimulation commands or training commands.

[0049] In particular, the processing unit is connected to the data transmission device for exchanging sensor data from external sensors. This allows, for example, sensor data from sensors mounted on a prosthesis and GPS data to be combined with the training data.

[0050] In particular, the computing unit has a computational algorithm so that the stimulation commands and / or the training commands can be generated reproducibly.

[0051] In particular, the calculation algorithm is a self-learning algorithm, which allows historical and current data to be easily linked together in the training device, thus enabling the training programs or stimulation programs to improve independently.

[0052] Preferably, the calculation algorithm processes external sensor data from external sensors of an artificial foot sole during operation, allowing the patient to be trained in advance, i.e. without having an artificial foot sole, with an artificial foot sole suitable for his circumstances.

[0053] Preferably, the control unit has a memory unit. This allows training programs, stimulation programs, training data, stimulation data, training commands, and / or stimulation commands to be stored in the training device.

[0054] Preferably, the housing of the training device comprises at least a second housing section, wherein a mounting unit for attaching the housing to a first prosthetic component of a prosthesis is provided on the second housing section. Using a rail system, a clip system, or a bayonet locking system as the mounting unit, the training device can be reproducibly arranged on a prosthesis, in particular on a prosthetic socket.

[0055] Preferably, the training device includes a positioning unit for positioning it on the first prosthetic component. This allows the multiple stimulators of the training device to be precisely positioned at their corresponding reinnervated nerve cell ends in the physionomy-typical nerve area segment. For example, a stop or a positioning screw is used as the positioning unit.

[0056] Preferably, the housing includes at least one further housing section with the visualization device, allowing the user of the training device to read at least individual training data or training commands, as well as stimulation data or stimulation commands and information about the training device, on the visualization device. Typically, this information about the training device includes information about the operating status of the training device and may include individual prompts for the user of the training device.

[0057] Preferably, the visualization device can display a representation of the physionomy-typical nerve area section including reinnervated nerve cell ends, thereby training visual receptors in the user's brain in addition to tactile perception.

[0058] Alternatively or additionally, a representation of the physionomy-typical nerve area segment, including the reinnervated nerve cell endings, can be displayed on a mobile device. This eliminates the need for a visualization unit in the training device, resulting in a more compact design and improved haptic feedback.

[0059] Alternatively or additionally, an animated representation of the physionomy-typical nerve area segment, including the reinnervated nerve cell ends, can be displayed together with the systematic arrangement of the multiple stimulators. This allows the user to observe the stimulation of individual stimulators at the respective reinnervated nerve cell ends in an animated manner and to correlate it with their perceived feelings / sensations, thereby improving the training of the user's tactile and visual receptors and integrating them in the user's brain.

[0060] Alternatively or additionally, another housing section includes an energy storage unit. This allows for a compact design within the training device housing and enables the battery or accumulator to be positioned as the energy storage unit in such a way as to ensure even weight distribution within the housing. This improves training comfort for the patient.

[0061] In particular, the energy storage unit features a charging coupling unit that allows it to be inductively recharged using a separate charging unit. This enables wireless recharging of the energy storage unit. For example, the charging coupling unit includes at least one magnet for inductively charging the energy storage unit.

[0062] Preferably, the control unit is equipped so that either a training program for training purposes or a stimulation program for stimulation via external sensors can be selected. This makes the training device multifunctional and suitable for various purposes.

[0063] In particular, the control unit automatically recognizes a rehabilitation mode (reha mode) and a prosthesis mode (aktive mode) using the recognition device located on the training device. This relieves the user of the task of selecting the currently required program on the training device.

[0064] Preferably, the recognition device is an RFID unit, which allows the training device to independently recognize its intended use without, for example, the need to connect a plug to the training device.

[0065] Another aspect of the invention relates to a method for operating a training device described herein, in particular as a modular stimulation device, comprising the following steps: Positioning the training device on a physionomie-typical nerve area segment with nerve cell ends, in particular with reinnervated nerve cell ends; displaying the nerve cell ends on a visualization device of the training device or on a mobile device.

[0066] The method used to operate the training device described here makes it possible to stimulate the postoperative growth of relevant nerve segments, reinnervated nerve cell endings, and their synapses. The user can monitor the training progress and stimulation process on the visualization device or a mobile device. This stimulates not only the tactile sensory system in the user's body but also the visual receptors, thereby improving overall perception and processing in the brain—and thus the success of the training.

[0067] Preferably, at least the training status or activity status of at least one of the several stimulators is also displayed on the visualization device or on the mobile device, so that the user of the training device can mentally link the triggering of a specific stimulation with a specific stimulator and thus improve the training effect.

[0068] Preferably, at least one stimulation command is then adjusted, giving the user the opportunity to respond to individual tactile stimuli.

[0069] Alternatively or additionally, at least one training command is then adjusted, giving the user the opportunity to react to individual tactile stimuli and to independently adjust the training of individual nerve cell endings.

[0070] Preferably, when adjusting at least one of the stimulation commands or at least one of the training commands, one of the several stimulation programs or one of the several training programs is selected. This allows the user, for example, to independently control the intensity of the stimulations or to adjust the training program to their individual needs.

[0071] Another aspect of the invention relates to the use of the training device described herein as a modular stimulation device for stimulating nerve cell endings, in particular reinnervated nerve cell endings. This allows the growth or sensitivity of nerve cell endings in the remaining part of a limb to be improved at a very early stage after limb loss, thus shortening the adaptation phase to a later necessary prosthesis with stimulation.

[0072] Preferably, the training device described herein is used in conjunction with the method described herein for operating the training device, which also stimulates the visual receptors in the user's brain and thus further shortens the habituation phase.

[0073] Another aspect of the invention relates to a prosthesis with a first prosthetic part, wherein the first prosthetic part has at least one receptacle for receiving a training device as a modular stimulation device and wherein the training device is separably / removably arranged on the at least one receptacle of the first prosthetic part.

[0074] With the prosthesis according to the invention, the user of a training device, which was used immediately after an operation to improve the growth or sensitivity of relevant nerve area sections or nerve cell ends, can subsequently use it together with the prosthesis for training purposes, but also for sensor use.

[0075] According to the invention, the device is designed like a window and typically includes a frame or insert in which the training device is placed. For example, a user who has had a foot amputated can thus use the training device not only as a rehabilitation module but also as a modular stimulation device. The modular stimulation device can be connected to an artificial foot sole, so that, for example, the rolling motion of the artificial foot along its gait is fed back to the modular stimulation device, thus giving the patient the sensation of walking (sensor insert). This not only improves the user's quality of life but also minimizes the notoriously high costs of prosthetic fittings and rehabilitation overall.

[0076] Advantageously, the receptacle has at least two openings, each suitable for receiving at least one stimulator of a training device. This prevents the training device from resting directly on the user's body part, ensuring that only the stimulators touch the user's body part and thus train the nerve endings. Furthermore, the prosthetic component remains dimensionally stable and retains sufficient strength when connected to the receptacle. In particular, the receptacle has a separate opening for each stimulator of the training device.

[0077] An advantageous feature is the placement of a sealing insert, for example made of silicone, between the recording device and the training device. This prevents the user's body part from being pushed outwards through the recording openings, which could cause skin irritation.

[0078] In particular, the first prosthetic component is a prosthetic socket, a prosthetic sock or cuff, or a prosthetic cosmetic component (the part of the prosthesis located between the prosthetic socket and the prosthetic foot). Depending on the amputated extremity, such as the thigh, lower leg, upper arm, or forearm, these first prosthetic components offer advantages in their application. For example, the arrangement of the modular stimulation or training device can be individually adapted to the user of the prosthesis, so that, depending on the user's needs and the comfort of wearing the prosthesis, the mounting point for the modular stimulation device can be positioned at different locations on the prosthesis.

[0079] In particular, the modular stimulation device is the training device described here.

[0080] Preferably, the first prosthetic component has at least one input unit for recognizing the training device. This allows the training device to automatically detect when it is positioned in the receptacle of the prosthetic component, thus simplifying operation of the training device for the user.

[0081] In particular, at least one input unit is an RFID unit, which automatically detects the placement of the training device in the prosthesis.

[0082] Preferably, the first prosthetic part has at least one prosthetic mounting unit, which allows the training device to be easily attached to the first prosthetic part.

[0083] Preferably, at least one prosthesis mounting unit is designed to be complementary to the first mounting unit of the training device. This prevents incorrect alignment of the training device with the first prosthesis component and thus extends the service life of the prosthesis with the training device. Typically, a rail system, a bayonet locking system, a pin-hole system, or another known quick-release system is used as the prosthesis mounting unit and as the mounting unit of the training device, which simplifies the arrangement of the training system on the prosthesis for the user.

[0084] In particular, at least one prosthesis mounting unit is arranged on the outer surface of the first prosthesis part, which allows the training device to be attached to the prosthesis even when it is in the user's hands.

[0085] Preferably, a fixation unit is provided for securing the training device to the first prosthetic component. Sufficient fixation of the detachable training device to the first prosthetic component is necessary to enable various movements, such as walking, climbing, or jumping, without the loss of contact between the multiple stimulators of the training device and the nerve cell endings of the physionomie-typical nerve area segment.

[0086] Preferably, external sensors are provided for detecting pressures acting on the prosthesis. These sensors are connected to the training device for receiving sensor data and are located in a separate part of the prosthesis. As previously described, the training device includes a data transmission unit, which, among other things, has a receiver for receiving sensor data. This allows the pressures acting on the prosthesis to be transmitted to the nerve cell endings in the physionomie-typical nerve area segment by means of the multiple stimulators systematically arranged in the training device, so that the user can feel the effect of the pressure on the prosthesis.

[0087] In particular, the external sensors are located on the insole of the artificial foot. Typically, the external sensors are positioned along the gait line on the insole, allowing the user of the prosthesis to perform movements with realistic sensation.

[0088] In particular, the external sensors are electrically connected to a transmitter unit on the artificial foot. This allows sensor data to be sent from the artificial foot to a receiver unit, so that the sensor data can be evaluated externally.

[0089] The transmitter unit is advantageously detachable from the prosthetic foot or cosmetic device. This transmitter unit can have a holding device and be magnetically attached to the prosthetic foot or cosmetic device, and be adjustable along its length. This allows the transmitter unit to be flexibly positioned and placed in a position suitable for the user of the prosthesis, according to their needs.

[0090] In particular, the transmitter unit has a charging coupling unit with which an energy storage unit within the transmitter unit can be inductively recharged using a separate charging unit. This allows the energy storage unit to be recharged wirelessly. For example, the charging coupling unit has at least one magnet for inductively charging the energy storage unit.

[0091] Alternatively or additionally, external sensors are available to detect forces acting on the prosthesis, allowing the user to perceive not only pressures during a walking movement, but also forces on the prosthesis, such as those resulting from a bump to the lateral prosthetic ridge section, or a combination of pressures and forces, thus enabling a realistic feeling with a prosthesis.

[0092] Another aspect of the invention relates to a method for manufacturing a prosthesis, comprising the following step: Manufacturing a receptacle for attaching a training device to a first prosthetic component of the prosthesis.

[0093] This allows for the production of a prosthesis that can be individually tailored to the user's needs and to which a training device can be attached as a modular stimulation device. This allows it to be combined with a training device that the user has previously used for rehabilitation purposes. This enables the user to train nerve cell endings, such as reinnervated nerve cell endings, at an early stage, and the same training device can later be used as a modular stimulation device within a prosthesis.

[0094] Preferably, the recording is designed like a window, so that the user can easily insert the training device into the recording and at the same time see their own or the physionomy-typical nerve area section from the outside and, if necessary, clean it beforehand, for example.

[0095] In particular, the training device is the one described here and is designed as a modular stimulation device. To this end, the training device features a systematic arrangement of several stimulators, which can be easily connected by the user to their respective nerve cell endings.

[0096] In particular, the prosthesis described here was manufactured using this method.

[0097] Preferably, after the recording has been made, the training device is inserted into the recording and fixed in the recording.

[0098] Another aspect of the invention relates to the use of the training device described herein for stimulating nerve cell endings, in particular reinnervated nerve cell endings, in a prosthesis described herein. This minimizes the notoriously high costs for a prosthesis wearer.

[0099] Further advantages, features and details of the invention will become apparent from the following description, in which exemplary embodiments of the invention are described with reference to the drawings.

[0100] The list of reference numerals, like the technical content of the patent claims and figures, forms part of the disclosure. The figures are described coherently and comprehensively. Identical reference numerals denote identical components; reference numerals with different indices indicate functionally identical or similar components.

[0101] This shows: Fig. 1 a training device according to the invention in a sectional view, Fig. 2 the training device according to Fig. 1in a top view, Fig. 3 one of the several stimulators of the training device according to the invention in a detailed view, Fig. 4 a prosthesis according to the invention without the training device in a sectional view, Fig. 5 the artificial sole of the prosthesis according to Fig 4 in a top view, and Fig. 6 the prosthesis according to the invention. Fig. 4 with the training device according to Fig. 1 in a perspective view.

[0102] Figure 1 and Figure 2Figure 10 shows the training device 10 according to the invention for the training stimulation of nerve cell endings. The training device 10 comprises a housing 11 with a first housing section 12, on which several stimulators 20 for stimulating physionomy-typical nerve area segments are arranged. For this purpose, the first housing section 12 has several housing openings 25 in which the stimulators 20 are arranged section by section. The training device 10 has, on a second housing section 13 of the housing 11, a mounting unit 15 for mounting the housing 11 on a first prosthetic part of a prosthesis, as well as a positioning unit 16 for positioning the training device 10 on a first prosthetic part of a prosthesis. A control unit 30 for controlling the several stimulators 20 is arranged in the housing 11.The control unit 30 comprises a computing unit 35, a processor, and a memory unit 36, which are electrically connected to each other and to the multiple stimulators 20. The computing unit 35 executes various stimulation programs to generate stimulation commands for a stimulation state of the multiple stimulators 20. Furthermore, the computing unit 35 executes various training programs to generate training commands for a training process for the multiple stimulators 20. The computing unit 35 has several computational algorithms for this purpose, which generate the stimulation commands and / or the training commands. The memory unit 36 ​​stores these multiple computational algorithms, which are retrieved by the computing unit 35 or the processor as needed.The control unit 30 is designed so that at least one training program for training purposes or one stimulation program for stimulation by means of the several stimulators 20 can be set.

[0103] According to this specific configuration, the training device 10 has a data transmission unit 40 with a transmitter 41 and a receiver 42 for wireless data exchange. The data transmission unit 40 is electrically connected to the control unit 30 and the computing unit 35. The data transmission unit 40 also has an interface 43 to which a remote device 68, such as a computer, can be electrically connected and on which a training program or a stimulation program can be defined. The transmitter 41 or the receiver 42 can be connected to a cloud 66 or to a mobile device 68 (smartphone, tablet, etc.) for exchanging data, for example, historical data.The transmitter unit 41 can also be connected to an external sensor, for example, a sensor on a prosthetic component or an external sensor such as a temperature sensor, a humidity sensor, or a GPS sensor, etc., for data exchange. The data can be transferred to the processing unit 35 and processed there in the processing algorithm, so that the control unit 30 can transmit stimulation commands and / or training commands to the multiple stimulators 20.

[0104] The housing 11 has a further housing section 14 with the visualization device 32, on which individual training data or training commands, as well as stimulation data or stimulation commands and information, such as messages, are displayed, optionally partially animated. The visualization device 32 is electrically connected to the control device 30 and receives the training data or training commands, as well as stimulation data or stimulation commands and information, from the control device 30. The visualization device 32 includes an input device 44, which is preferably designed as a touchscreen. In addition to a main switch (on / off switch), the input device 44 also includes a selection switch for selecting predefined training programs and / or stimulation programs.

[0105] An energy storage unit 38, a battery or accumulator, is arranged on the further housing section and is electrically connected to the control unit 30, the several stimulators 20, and the detection unit 45. The energy storage unit 38 also supplies the visualization unit 32 with energy.

[0106] A recognition device 45, as an RFID unit 46, is provided on the first housing section 12, so that the control unit 30 automatically recognizes the need for a rehabilitation mode (reha mode) and a prosthesis mode (aktive mode) - depending on what is directly connected.

[0107] The multiple stimulators 20 are systematically arranged on the first housing section 12, so that, in the training state, they can act on their respective assigned nerve cell endings. The systematic arrangement of the multiple stimulators 20 replicates the gait pattern 63 of a human foot. The multiple stimulators 20 are arranged in a lightning bolt shape on the first housing section 12. In the example shown in Figure 2 Five stimulators 20 are required to represent the gait pattern 63 of the human foot. The systematic arrangement of the multiple stimulators 20 is such that each stimulator 20 corresponds perfectly to at least one associated nerve cell terminal in the physionomy-typical nerve area segment.

[0108] Figure 3Figure 1 shows one of several stimulators 20 for stimulating nerve cell terminals, which are arranged on the first housing section 12. The stimulator 20 has a vibration generator 21 with a vibration generator housing 26, which is connected to a spring element 23 as a decoupling element 24. The spring element 23 is a rod-shaped spring wire that is arranged on one side of the vibration generator housing 26. For this purpose, the spring element 23 is attached to the vibration generator housing 26 at one end. The spring element 23 decouples the vibrations or oscillations of the vibration generator 21 from the environment. The other end of the spring element 23 is attached to a mounting section 22 of the first housing section 12 by a fastening means 29 and is supplied with energy via the supply lines 27. The stimulator 20 is arranged to be spatially adjustable along the housing section 12 in a longitudinal direction.Furthermore, the stimulator 20 is rotatably arranged about the fastening element 29, whereby the fastening element 29 can be released. The housing openings 25 are designed accordingly for this purpose. Alternatively, another rod-shaped spring element is arranged between the fastening section 22 and the vibration generator housing 26 (not shown). The vibration generator housing 26 is inserted at least partially into the housing opening 25, such that the vibration generator housing 26 at least partially penetrates the housing opening 25. An eccentric element 28 is arranged in the vibration generator housing 26. The eccentric element 28 is rotatably mounted in the vibration generator housing 26. The vibration of the vibration generator 21 is caused by the eccentric element 28 via the changing direction of the centripetal force of the eccentric element 28.The vibrator 21 has a drive motor in its vibrator housing 26 for the rotary drive of the eccentric element 28 (not shown). The drive motor is connected to the energy storage unit 38. Alternatively, instead of the eccentric element, the vibrator 21 has a vibration element which moves along a straight guide and triggers a vibration due to the inertia of the vibration element (not shown).

[0109] The invention also relates to a method for operating the training device 10 described herein, in particular as a modular stimulation device, comprising the following steps: Positioning the training device 10 on a physionomy-typical nerve area section 71 with nerve cell ends, in particular with reinnervated nerve cell ends 72; displaying the nerve cell ends or their associated original site of action on the amputated extremity of the patient on a visualization device 32 of the training device 10 or on a mobile device 67.

[0110] In addition, the multiple stimulators 20 are displayed on the visualization device 32 or on the mobile device 67, so that the user of the training device 10 can mentally link the triggering of a specific stimulation with a specific stimulator 20 and thus improve the training effect.

[0111] Subsequently, at least one stimulation command and / or at least one training command is adjusted at the input device 44 of the visualization device 32 or at the mobile device 67. One of the several stimulation programs or one of the several training programs is selected and then executed by the control device 30. The several stimulators 20 are activated sequentially or simultaneously according to the program, so that they stimulate the nerve cell endings in the physionomy-typical nerve area segment 71.

[0112] Another aspect of the invention relates to the use of the training device 10 described herein as a modular stimulation device for stimulating nerve cell ends, in particular reinnervated nerve cell ends.

[0113] The Figure 4Figure 50 shows a prosthesis with a prosthetic socket 51 as the first prosthetic component, which is attached to an extremity 69. The prosthetic socket 51 has a receptacle 52 for receiving a training device as a modular stimulation device. The training device can be detached and attached to the receptacle 52 of the prosthetic socket 51. The receptacle 52 is window-shaped and includes a frame in which the training device is inserted. The receptacle 52 is located in the area of ​​a skin region 70 of the remaining extremity 69 and allows external access to the skin region 70. This skin region 70 contains the physionomy-typical nerve region segment 71 with the reinnervated nerve cell ends 72 arranged therein. In this example, the reinnervated nerve cell ends 72 are arranged according to a specific matrix, or in a lightning-like pattern, within the physionomy-typical nerve region segment 71.The reinnervated nerve cell ends 72 lie along the image of a gait pattern 63. The prosthetic socket 51 has an input unit 54, in the form of an RFID unit, which interacts with the RFID unit of the training device and automatically recognizes it when attached to the prosthesis 50. The prosthetic socket 51 has a prosthetic mounting unit 55, which allows the training device to be attached to the prosthetic socket 51. The prosthesis 50 has a prosthetic cosmetic 59 and an artificial foot 60 with an artificial sole 61, which also carries a gait pattern 62 of the artificial sole 61, or rolls along it when the artificial foot walks. The receptacle 52 has receiving openings 53, which are suitable for receiving at least one stimulator 20 of a training device. A sealing insert 57, for example made of a silicone material, can be arranged between the receptacle 52 and the training device.

[0114] Figure 5 Figure 61 shows the artificial foot sole 61 of the prosthesis 50. Five external sensors 65, designed as pressure sensors, are arranged on the artificial foot sole 61. The external sensors 65 are arranged in a lightning bolt shape on the artificial foot sole 61 and lie along the gait line 62 of the artificial foot sole. In the embodiment shown, the shape of the image of the gait line 63 is on the physionomie-typical nerve area segment 71 of the extremity 69 ( Figure 4 ) equal to the shape of the gait line 62 of the artificial foot sole 61. However, it is possible to design the image of the gait line 63 independently of the gait line 62 of the artificial foot sole 61. The only crucial point is that the respective stimulators 20 of the training device 10 are assigned to the respective nerve cell endings in the physionomy-typical nerve area section 71.

[0115] Figure 6Figure 1 shows the prosthesis 50 described here with the training device 10 mounted on the receiver 52. The mounting unit 15 of the training device 10 engages complementarily with the prosthesis mounting unit 55 on the prosthesis socket 51. The training device 10 can be positioned using the positioning unit 16 and is attached or fixed to the prosthesis socket 51 using the fixation unit 58. The training device 10, with its systematically arranged stimulators 20, is positioned at their respective nerve cell ends on the physionomy-typical nerve area segment 71 of the extremity 69, such that the image of the gait pattern 63 corresponds to the systematic arrangement of the multiple stimulators 20.

[0116] Several external sensors 65 for detecting pressures acting on the prosthesis 50 are arranged on the artificial foot sole 61 of the artificial foot 60. These external sensors 65 are arranged along the gait line 62 and electrically connected to the transmitter unit 64 of the artificial foot 60. The transmitter unit 64 is detachably attached to the artificial foot 60 or to the cosmetic component 59. The transmitter unit 64 is magnetically attached to the artificial foot 60 or the cosmetic component 59 by means of a holding device and is adjustable along this line. The prosthesis 50 can also have additional external sensors for detecting forces acting on it. These external sensors are, for example, arranged on a prosthetic limb section located laterally on the artificial foot 60 and transmit sensor data to the training device 10, which is triggered by a push against these external sensors in the prosthetic limb section (not shown).The transmitter unit 64 sends the sensor data from the external sensors 65 and the sensors on the prosthetic groin section to the receiver unit 42 of the data transmission device 40 of the training device 10. The sensor data is then forwarded to the control unit 30. The transmitter unit 64 can have a charging coupling unit with which an energy storage unit in the transmitter unit can be inductively recharged by means of a separate charging unit (not shown).

[0117] As in Figure 6As shown, the prosthetic socket 51 has a receptacle 52 for receiving the training device 10. During the manufacture of the prosthesis 50, a window-like receptacle 52 for attaching the training device 10 is produced on the prosthetic socket 51. Alternatively, a box-shaped receptacle is produced in which the training device 10 is attached. The training device 10 is then inserted into the window-like receptacle 52, whereby the training device 10 is recognized by the input unit 54 of the prosthesis 50 via its recognition device 45, so that the control unit 30 automatically switches to prosthesis mode. The transmitter unit 64 on the artificial foot 60 sends the sensor data from the external sensors 65 and the sensors on the prosthetic limb section to the receiver unit 42 of the data transmission unit 40 of the training device 10. The sensor data is then forwarded to the control unit 30 and processed there.In the processing unit 35 of the control device 30, the sensor data from the external sensors are transferred into stimulation commands for the respective assigned stimulators 20. The respective stimulator 20 then stimulates the nerve cell end assigned to it at the physionomy-typical nerve cell segment 71.

[0118] Thus, the training device 10 is generally used in rehabilitation mode when separated from the prosthesis 50, and in prosthesis mode when attached to the prosthesis 50. Deviations from this rule can be provided for, for example, if the user wishes to receive training with the prosthesis attached. Reference symbol list

[0119] 10 Training device 11 Housing 12 First housing section 13 Second housing section 14 Further housing section 15 Mounting unit 16 Positioning unit 20 Stimulators 21 Vibration generator 22 Mounting section 23 Spring element 24 Decoupling element 25 Housing opening 26 Vibration generator housing 27 Supply line 28 Eccentric element 29 Fastening device 30 Control unit 32 Visualization unit 35 Computing unit 36 ​​Storage unit 38 Energy storage unit 40 Data transmission unit 41 Transmitting unit 42 Receiving unit 43 Interface 44 Input unit 45 Recognition unit 46 RFID unit 50 Prosthesis 51 Prosthesis socket 52 Receptacle 53 Receptacle openings 54 Input unit 55 Prosthesis mounting unit 57 Sealing insert 58 Fixation unit 59 Prosthetic cosmetics 60 Artificial foot 61 Artificial foot sole 62 Gait line 63 Image of the gait line 64 Transmitter unit 65 External sensors 66 Cloud 67 Mobile device 68 Remote device 69 Extremity 70 Skin area 71 Physionomy-typical nerve area segment 72 InnervatedNerve cell ending

Claims

1. A training apparatus (10) for the training simulation of reinnervated nerve cell endings (72) of a foot, comprising a housing (11) with at least one first housing section (12) and with a plurality of stimulators (20) for stimulating nerve area sections (71) characteristic of the foot's anatomy, characterized in that a plurality of stimulators (20) are arranged systematically, corresponding to the nerve area sections (71) characteristic of the foot's anatomy, at least on the first housing section (12) of the housing (11), and a plurality of housing openings (25) are provided in the first housing section (12), in which the plurality of stimulators (20) are arranged in sections corresponding to the nerve area sections (71) characteristic of the foot's anatomy, such that, in the training state, the plurality of stimulators (20) act upon the reinnervated nerve cell endings respectively assigned to them.

2. The training apparatus (10) according to claim 1, characterized in that a controller (30) is provided for controlling the plurality of stimulators (20), which comprises at least one training program and is coupled to a visualization device (32) to visually display a training stimulation from the at least one training program to the patient.

3. The training apparatus (10) according to claim 2, characterized in that the controller (30) is arranged within the housing (11) and is preferably controllable via an external remote device (68), in particular a mobile terminal (67).

4. The training apparatus (10) according to any one of the preceding claims, characterized in that the training apparatus (10) comprises a data transmission device (40) for transmitting data, wherein the data transmission device (40) is preferably located in the controller (30), such that external training data and / or stimulation data can be transmitted to the controller (30).

5. The training apparatus (10) according to claim 4, characterized in that the data transmission device (40) comprises an interface (43) via which a user can define training programs and / or stimulation programs, wherein the interface (43) comprises, in particular, an input device (44) for inputting control data, and wherein the input device (44) is preferably arranged on the visualization device (32), in particular integrated therein as a touchscreen.

6. The training apparatus (10) according to any one of the preceding claims, characterized in that the data transmission device (40) is capable of receiving external sensor data (65) from a prosthesis (50), preferably an artificial foot sole (61), and / or is connected to a plurality of external sensors (65), and wherein the data transmission device (40) is preferably connected to a cloud (66) within a network for the purpose of exchanging data.

7. The training apparatus (10) according to any one of the preceding claims, characterized in that the controller (30) comprises a processing unit (35), wherein the processing unit (35) comprises at least one stimulation program for generating stimulation commands for a stimulation state and / or at least one training program for generating training commands for a training process.

8. The training apparatus (10) according to claim 7, characterized in that the processing unit (35) is connected to the data transmission device (40) for exchanging data, in particular external sensor data, and in particular, the processing unit (35) comprises a processing algorithm that, in the operating state, preferably processes external sensor data from external sensors (65) of an artificial foot sole (61).

9. The training apparatus (10) according to any one of the preceding claims, characterized in that the housing (11) comprises at least a second housing section (13), wherein a mounting unit (15) for mounting the housing (11) to a first prosthetic component of a prosthesis (50), in particular to a prosthetic socket (51), is provided on the second housing section (13).

10. The training apparatus (10) according to any one of the preceding claims, characterized in that a positioning unit (16) for positioning the training apparatus (10) on the first prosthetic part of a prosthesis (50) is provided, and preferably the housing (11) comprises at least one additional housing section (14) with the visualization device (32) and / or comprises an energy storage unit (38).

11. The training apparatus (10) according to any of the preceding claims, characterized in that the controller (30) is configured such that either a training program for training purposes or a stimulation program for stimulation via external sensors (65) is selectable, wherein the controller (30) automatically detects, in particular, a rehabilitation mode and a prosthesis mode by means of a detection device (45), wherein the detection device (45) is preferably an RFID unit (46).

12. A method for operating a training apparatus (10), in particular as a modular stimulation apparatus, according to one of the preceding claims, comprising the following steps: - positioning the training apparatus (10) on a nerve area section (71) typical for the anatomy of a foot, containing nerve cell endings, in particular reinnervated nerve cell endings (72); - displaying the nerve cell endings on a visualization device (32) of the training apparatus (10) or on a mobile terminal (67), wherein, preferably, at least the training status of at least one of the plurality of stimulators (20) is additionally displayed.

13. The method according to claim 12, characterized in that at least one stimulation command of at least one of the plurality of stimulators (20) is adjusted.

14. Use of the training apparatus (10) according to any one of claims 1 through 11 as a modular stimulation apparatus for stimulating nerve cell endings, in particular reinnervated nerve cell endings (72), preferably with a method according to claim 12 or 13.

15. The use of a training apparatus (10) for stimulating nerve cell endings, in particular reinnervated nerve cell endings (72), according to any one of claims 1 through 11, in a prosthesis (50).