SYSTEM AND METHOD FOR THE REGENERATION OF AT LEAST ONE SEVERED NERVE CONDUIT

Abstract

The invention relates to a system and a method for regeneration of at least one severed nerve conduit (1), in a living human or animal body, having a motion device (20), with which a body part (4) of the human or animal body can be moved, containing at least one skeletal muscle (S) that is otherwise innervatable with the severed nerve conduit (1), having a signal generator unit (30), which generates a first electrical stimulation signal (31) and a second electrical stimulation signal (32), as well as having an evaluation and control unit (10), which controls the motion device (20) as well as the signal generator unit (30) so they are coordinated with one another, such that the signal generator unit (30) applies the first stimulation signal (31) to the nerve conduction part (2) that has been separated from the skeletal muscle (S) by means of a first applicator (33), and the motion device (20) moves the body part (4) in chronological coincidence therewith, and during or after movement of the body part (4), the signal generator unit (30) applies the second stimulation signal (32) via the first applicator (33) or a second applicator (34) to the nerve conduction part (3) separated from the skeletal muscle (S).

Claims

1. A system for regeneration of at least one severed nerve conduit, in a living human or animal body, comprising a motion device, with which a body part of the human or animal body can be moved, containing at least one skeletal muscle (S) that is otherwise innervatable with the severed nerve conduit, having a signal generator unit, which generates a first electrical stimulation signal and a second electrical stimulation signal, as well as having an evaluation and control unit, which controls the motion device as well as the signal generator unit so they are coordinated with one another such that the signal generator unit applies the first stimulation signal to the nerve conduction part that has been separated from the skeletal muscle (S) by means of a first applicator, and the motion device moves the body part in chronological coincidence therewith, and during or after the movement of the body part, the signal generator unit applies the second stimulation signal via the first applicator or a second applicator to the nerve conduction part separated from the skeletal muscle (S).

2. The system according to claim 1, wherein the signal generator unit generates a third electrical stimulation signal which can be applied to the skeletal muscle (S) by means of a third applicator, and the evaluation and control unit controls the signal generator unit such that the third stimulation signal can be applied to the skeletal muscle (S) simultaneously with the first stimulation signal or while the motion device is moving the body part.

3. The system according to claim 1, wherein an injector system is provided which can be controlled by means of the evaluation and control unit and applies at least one active ingredient in the area of the severed nerve conduit.

4. The system according to claim 1, wherein at least one memory unit is provided in which data (D) is stored, and on the basis of the data the evaluation and control unit controls the motion device and the signal generator unit.

5. The system according to claim 1, wherein the first applicator has an electrode array and/or the second applicator has an electrode array.

6. The system according to claim 2 wherein the third applicator has an electrode array.

7. The system according to claim 1, wherein the motion device has an orthotic device or an exoskeleton.

8. The system according to claim 1, wherein the evaluation and control unit, the signal generator unit and/or the memory unit are arranged on the orthotic device or the exoskeleton and form an independent unit.

9. The system according to claim 1, wherein the motion device has at least two components that are connected to one another by means of a joint as well as having at least one actuator by means of which the components can be moved relative to one another, and the actuator can be controlled by means of the evaluation and control unit.

10. The system according to claim 9, wherein a motion sensor system is provided on the motion device, detecting at least the relative spatial position of the components and generating at least one first motion sensor signal which can be evaluated by means of the evaluation and control unit.

11. The system according to claim 10, wherein the system can be put in an operating state in which the motion device can be moved by the evaluation and control unit without support of the actuator and/or without control by the evaluation and control unit, and the evaluation and control unit generates motion data in this operating state on the basis of the first motion sensor signals generated by the motion sensor system and stores the motion data in the memory unit.

12. The system according to claim 10, wherein the motion sensor system detects the forces and/or torques occurring on the motion device during a movement and generates at least one second motion sensor signal, and a comparator unit is provided, which compares the second motion sensor signal with reference data (R) and, if a deviation exceeding a preselectable threshold is found, generates a signal, and the comparator unit is connected to the evaluation and control unit which evaluates the signal.

13. The system according to claim 4, wherein a detector which detects electrical brain signals and generates a detector signal is provided; the detector is connected to the evaluation and control unit which evaluates the detector signal and controls the motion device as well as the signal generator unit in accordance with data (D) stored in the memory unit.

14. The system according to claim 1, wherein the evaluation and control unit has an interface by means of which the evaluation and control unit can be connected wirelessly or in a hardwired connection to at least one external memory unit and/or at least one external evaluation and control unit.

15. The system according to claim 2, wherein a first sensor unit is provided, detecting a natural electrical nerve signal intended for stimulation of the skeletal muscle (S) and generating at least one first sensor signal, the first sensor unit is connected to the evaluation and control unit, and the evaluation and control unit evaluates the first sensor signal and controls the signal generator unit on the basis of the first sensor signal evaluated to generate the third stimulation signal.

16. The system according to claim 1, wherein a second sensor unit is provided, detecting an electrical nerve signal of the sensory nerve conduction part connected to the skeletal muscle (S) and/or detects an activity of the skeletal muscle (S) and generates at least one second sensor signal, the second sensor unit is connected to the evaluation and control unit, and the evaluation and control unit evaluates the second sensor signal and controls the signal generator unit on the basis of the evaluated second sensor signal to generate the second stimulation signal.

17. The system according to claim 1, wherein the at least one severed nerve conduit comprises at least one motor nerve conduction part and/or at least one sensory nerve conduction part, and the signal generator unit applies the first stimulation signal via the first applicator to the motor nerve conduction part separated from the skeletal muscle (S) and in chronological coincidence therewith, the motion device moves the body part and during or after the movement of the body part, the signal generator unit applies the second stimulation signal via the first applicator or a second applicator to the sensory nerve conduction part separated from the skeletal muscle (S).

18. The system according to claim 17, wherein a sensor system which detects a quantifiable change in state and generates a sensor signal of the motor nerve conduction part, the sensory nerve conduction part, the skeletal muscle (S) and/or the body part, and the sensor system is connected to the evaluation and control unit which evaluates the sensor signal.

19. A method for regenerating at least one severed nerve conduit in a living human or animal body, which contains a body part having at least one skeletal muscle (S) that would otherwise be innervatable with the severed nerve conduit, characterized by the following method steps: generating a first electrical stimulation signal, applying the first electrical stimulation signal to a nerve conduction part separated from the skeletal muscle (S) of the severed nerve conduit, moving the body part in chronological coincidence with application of the first electrical stimulation signal to the nerve conduction part separated from the skeletal muscle, generating a second electrical stimulation signal, and applying the second electrical stimulation signal during or after the movement of the body part on a nerve conduction part that is separated from the skeletal muscle (S).

20. The method according to claim 19, wherein the first electrical stimulation signal is applied to the motor nerve conduction part, and the second electrical stimulation signal is applied to the sensory nerve conduction part.

21. The method according to claim 19, wherein a third electrical stimulation signal is generated, and the third electrical stimulation signal is applied to the skeletal muscle (S) simultaneously with the first stimulation signal or while carrying out the movement of the body part.

22. The method according to claim 19, wherein before, during or after application of the first and/or second electrical signals, an active ingredient is applied in the area of the severed nerve conduit.

Description

BRIEF DESCRIPTION OF THE INVENTION

[0096] The invention is described below on the basis of exemplary embodiments with reference to the drawings as an example, without restriction of the general inventive idea of the invention, in which:

[0097] FIG. 1 shows a schematic diagram of one embodiment of the system according to the invention,

[0098] FIG. 2 shows a schematic diagram of a preferred embodiment of the system according to the invention,

[0099] FIG. 3 shows a schematic diagram of a simple motion device,

[0100] FIG. 4 shows a schematic diagram of possible locations where the preferred sensor system can be placed,

[0101] FIG. 5 shows a schematic diagram of a preferred embodiment with a first and a second sensor unit, and

[0102] FIG. 6 shows a schematic diagram of a nerve cell with afferent cell projections (dendrites) and efferent cell projections (neurite, axon).

WAYS OF IMPLEMENTING THE INVENTION, COMMERCIAL APPLICABILITY

[0103] FIG. 1 shows a greatly simplified schematic diagram of a severed nerve conduit 1 having a separation point 5. The term separation point 5 need not necessarily be understood to refer to the location of a lesion in the narrower sense, but instead this refers to a region of a functional interruption in or disturbance of nerve conduction, along which at least there is irritation in the nerve signal transmission, by means of which the natural nerve signal transmission is disturbed. The nerve conduction 1 comprises a motor nerve conduction part 2 and a sensory nerve conduction part 3, which originally innervated the skeletal muscle S, i.e., the skeletal muscle S was stimulated to contraction by the motor nerve conduction part 2 and the signals generated by the muscle, for example, by at least one muscle spindle and/or at least one Golgi tendon apparatus are conducted via the reflex arc back to the spinal cord and from there to the brain H and/or to the corresponding lower motor neuron as the feedback signal which indicates contraction.

[0104] The motor nerve conduction part 2 and/or the sensory nerve conduction part 3 was/were each divided into a nerve conduction part 2, 3 separated from the skeletal muscle S and a nerve conduction part 2, 3 connected to the skeletal muscle, this division being accomplished by the separation point 5, which represents a functional interruption. Therefore, nerve signals that should be transmitted over the motor nerve conduction part 2 to the skeletal muscle S no longer arrive there. Accordingly, the sensory nerve conduction part 3 separated from the skeletal muscle S also no longer receives feedback signals from the skeletal muscle S, for example, from the muscle spindle and/or from the Golgi tendon apparatus, so that neither the spinal cord (including the lower motor neuron) nor the brain is informed about contraction of the skeletal muscle S and the associated movement.

[0105] Interruption of this closed system can lead to a further regression of nerve conduction and/or loss of arbitrary control, i.e., the ability of the brain to transmit nerve signals suitable for initiating a muscle movement.

[0106] The invention described below is based on the finding that a damaged neuron, which should grow back into the separated region and/or a restored or prepared nerve connection that is to be integrated, requires a stimulus to do so.

[0107] The system according to the invention begins at this point, i.e., it enables movement of the body part in combination with nerve stimulation signals, which correspond to those that naturally correlate with the movement of the body part, in particular with the contraction of the skeletal muscle S. Accordingly, the system according to the invention has a motion device 20 that moves the body part in question and a signal generator unit 30 generating a first stimulation signal 31 and a second stimulation signal 32. The first stimulation signal 31 is applied by means of the first applicator 33 to the motor nerve conduction part 2 separated from the skeletal muscle S, wherein the first stimulation signal 31 is designed in amplitude and signal form in particular, so that it generates a nerve signal along the motor nerve conduction part 2 separated from the skeletal muscle S, corresponding to the natural nerve signal occurring there for arbitrary or non-arbitrary control of the skeletal muscle S. The last neuron before the separation point, in particular its dendrites, is/are therefore stimulated artificially. The second stimulation signal 32 is also applied to the sensory nerve conduction part 3 separated from the skeletal muscle S either also via the first applicator (see FIG. 2) or via a second applicator 34 (see FIG. 1). In doing so, the dendrites of the neuron of the sensory nerve conduction part, which are closest to the separation point and/or from which the nerve signal generated artificially by means of the second nerve stimulation signal is relayed as a feedback signal in the direction of the spinal cord and/or the brain, are to be regarded as the first suitable site for stimulation. In this way, ultimately the last neuron of the motor nerve upstream from the separation point 5 receives a feedback signal via the detour of reflex arc and/or the spinal cordbrainspinal cord pathway.

[0108] The system according to the invention also has an evaluation and control unit 10, which is connected to and controls the motion device 20 and the signal generator unit 30, so that the first stimulation signal 31 is applied in chronological coincidence with the movement of the body part 4 carried out by the motion device 20, and the second stimulation signal 32 is applied during or after the movement of the body part 4. However, the second stimulation signal 32 is at least offset in time from the first stimulation signal 31, as is also the case in the natural system.

[0109] Besides the above-mentioned variant according to the invention for application of the second stimulation signal 2 via the first applicator 31, FIG. 2 also shows additional preferred refinements of the system. These include a third applicator 40, by means of which a third electrical stimulation signal 41 generated by the signal generator unit 30 can be applied to the skeletal muscle S. In doing so, the third applicator 40 can stimulate the skeletal muscle S directly, as indicated in FIG. 2, i.e., excite it to contraction, or stimulate it indirectly, i.e., by stimulation of a part of the motor nerve conduction part 2 (not shown) that is still connected to the skeletal muscle and is still functional. In doing so the evaluation and control unit 10 controls the signal generator 30, so that the third stimulation signal 41 is applied to the skeletal muscle S simultaneously with the first stimulation signal 31 or while the motion device 20 is moving the body part 4. Simultaneously means that, in any case, a possible time lag between stimulation of the skeletal muscle S and of the motor nerve conduction part 2 separated from the skeletal muscle S corresponds to the natural transit-time-related time lag and optionally to its biological processing time.

[0110] FIG. 2 also shows an injector system 50, by means of which active ingredients can be administered in the area of the severed nerve conduit 1. The application site is preferably to be selected, so that the active ingredients can be absorbed by the neurons and/or cells, which should be stimulated to growth and/or to integration. The injector system 50 is preferably connected to the evaluation and control unit 10 and can be controlled by means of it, i.e., in particular it is possible to influence the release of active ingredients in both time and amount. Thus, for example, the nerves send out their projections on the basis of the gradients of certain messenger substances, i.e., it may easily become necessary to apply certain growth factors directly to the damaged site but also to the target region. Application of the active ingredients and/or growth factors directly to the cell body may be appropriate.

[0111] FIG. 2 also shows a preferred memory unit 60, in which data D is stored on the basis of which the evaluation and control unit 10 controls the motion device 20 and the signal generator unit 30. Data D preferably comprises motion data BD for controlling the motion device as well as stimulation data SD for controlling the signal control unit which in turn generates at least one first stimulation signal 31, one second stimulation signal 32 and one third stimulation signal 41 in accordance with the stimulation data. Likewise, data D may also include data ID relating to the release of the active ingredient via the injector system. Motion data BD, stimulation data SD and, optionally, injector system data ID form the data record. A plurality of such data records may also be stored in memory unit 60.

[0112] FIG. 2 also indicates a power supply unit 130, which supplies power directly and/or indirectly to the system components, i.e., evaluation and control unit 10, motion device 20, signal generator unit 30, injector system 50 and/or memory unit 60.

[0113] FIG. 2 also illustrates as a preferred embodiment a detector unit 70, designed so that it detects electrical brain signals and generates a detector signal 71, which is evaluated in evaluation and control unit 10 connected to detector unit 70. Evaluation and control unit 10 is designed to control the motion device 20 and the signal generator unit 30 as a function of detector signal 71, which is evaluated in accordance with data D stored in memory unit 60. Detector unit 70 in particular is designed, so that a hypnotic brain state is detected, and a predefined movement is carried out by means of the motion device 20 during the hypnotic state.

[0114] FIG. 3 shows schematically a motion device 20 having two components 21, 22 connected to one another by means of a joint 23. The components 21, 22 are movable relative to one another by means of the actuator 24, wherein the actuator 24 can be controlled by the evaluation and control unit 10 according to the predetermined motion data. Motion device 20 may have substantially more components 21, 22 that are movable relative to one another, each with the respective actuators 24. In particular, a complete exoskeleton has a plurality of components 21, 22 and actuators 24, wherein the actuators make it possible to execute rotational movements or bending movements, for example, by means of which components connected directly or indirectly to one another by means of actuator 24 can be rotated or bent at an angle relative to one another.

[0115] Motion device 20 can preferably be put in a passive operating state in that, although components 21, 22 are movable relative to one another, they cannot be moved actively by means of actuator 24. By means of a motion sensor system 25, which is provided on the motion device 20, the relative spatial position of components 21, 22 can be detected, in particular even when motion device 20 is placed in the passive operating state described above. By carrying out a passive movement of the motion device 20, initial motion sensor signals 26 can then be generated by means of the motion sensor system 25 and evaluated by the evaluation and control unit 10 and reflect the motion sequence carried out passively in the form of motion data BD. This motion data can then be stored in memory unit 60 or, alternatively, in the external memory unit 91. External memory unit 91 and/or external evaluation and control unit 92 are connected wirelessly or in a hardwired connection to the evaluation and control unit 10 by means of the interface 90 arranged on the evaluation and control unit 10.

[0116] Detection of motion data BD is especially advantageous when the motion device 20 is arranged on a body part 4 of a healthy person or is applied to a healthy person in the case of an exoskeleton. The healthy person then carries out a movement, whose sequence is stored in the form of motion data BD. During the movement, motion sensor system 25 detects the relative spatial positions of components 21, 22 and generates corresponding first motion sensor signals 26, which are transmitted to evaluation and control unit 10, which is connected to motion sensor system 25 and then evaluates these initial motion sensor signals 26, generating therefrom motion data BD illustrating the motion sequence, characterized in the simplest case by a starting position and an end position. By recording a plurality of relative spatial positions of components 21, 22 and generating corresponding first motion sensor signals 26, a more complex motion sequence and/or a motion sequence in the form of motion data BD represented in greater detail can be saved. Alternatively, it is possible to carry out the movements with the patient, wherein a therapist carries out the movements in the style of the Feldenkrais method, for example.

[0117] Motion sensor system 25 preferably also detects forces and/or torques occurring during a movement on the motion device and generates at least one second motion sensor signal 28 which is sent to a comparator unit 120, which compares the second motion sensor signal 28 with reference data R and generates a signal 29, if a deviation is found in excess of a predefinable threshold. This signal is evaluated by the evaluation and control unit 10 connected to the comparator unit 120. In the simplest case, the occurrence of forces and/or torques exceeding the threshold is then displayed on a visual and/or acoustic display 121. Alternatively, however, when the predefinable threshold is exceeded, possibly indicating increased arbitrary movement of the body part by the patient, other data D is used by evaluation and control unit 10 as the basis for further treatment. This data is either already stored in memory unit 60 or external memory unit 91, or the data can be determined by the evaluation and control unit 10.

[0118] However, the fact that the predefinable threshold has been exceeded can also be interpreted as a sign of a defect in the motion device and/or the need for a repair of the motion device.

[0119] FIG. 4 shows a sensor system 80 by means of which a quantifiable change in state can be detected on the motor nerve conduction part 2, on the sensory nerve conduction part 3, on the skeletal muscle S and/or on body part 4. In this case, the sensor system 80 generates a sensor signal 81 which is evaluated by the evaluation and control unit 10 connected to the sensor system 80. FIG. 4 shows various detection sites, where the sensor system 80 can detect changes in state individually or in combination. FIG. 4 also illustrates a display module 11 connected to the evaluation and control unit 10 and an input module 12. In the simplest case the evaluation and control unit 10 is a computer, the display module 11 is a display screen and the input module 12 is a keyboard and/or a computer mouse.

[0120] FIG. 5 shows a preferred embodiment with a first sensor unit 100 which detects a natural electrical nerve signal 101 intended for stimulation of the skeletal muscle S then generates at least one first sensor signal 102 which is evaluated by means of the evaluation and control unit 10 connected to the first sensor unit 100. The evaluation comprises at least one filtering, one amplification and/or one processing of the at least one first sensor signal 102. Evaluation of the sensor signal 102 makes it possible to filter the natural nerve signal for triggering the skeletal muscle S out of the noise and/or out of interference signals and be able to generate a third stimulation signal 41 corresponding to this nerve signal by means of the signal generator unit which is applied to the skeletal muscle by means of the applicator 40. Due to the interaction of the first sensor unit 100, evaluation and control unit 10, signal generator unit 30 and applicator 40, the motor nerve conduction part 2 that is interrupted by the separation point is more or less bridged.

[0121] By analogy with this, a second sensor unit 110 which detects an electrical nerve signal 111 of the sensory nerve 3 connected to the skeletal muscle S and/or detects activity of the skeletal muscle S is provided for bridging the sensory nerve conduction part 3 interrupted by the separation point and generates at least one second sensor signal 112 which evaluates the evaluation and control unit 10 connected to the second sensor unit 110. Here again as described above, the evaluation serves to gain a second stimulation signal 32 which corresponds to the natural signal.

[0122] Additional advantages and explanations of additional preferred embodiments of the system according to the invention:

[0123] The system according to the invention makes it possible to bridge the damaged location in the reflex arc in such a way that the reflex arc remains functionally in operation.

[0124] If necessary, stem cells which differentiate to form nerve cells in the neural environment may be introduced into the spinal cord. In this case they replace the original nerve cell. The new nerve cell can be influenced in a positive sense to grow into the location by administering suitable messenger substances and/or growth factors.

[0125] Another possibility consists of transplanting nerve cells or supporting cells from other tissues into the spinal cord so that they can then support the development of new nerve cells. As in the case of stem cells, integrated new nerve cells also replace the old nerve cells. Again in this case it may be helpful to administer supporting factors.

[0126] This system is characterized in that it can maintain the natural function of a reflex arc despite damage and after damage and can thereby bring the damaged components or the new components replacing them into an environment that promotes regeneration and prevents natural degradation of biological structures due to suppressed intercellular communication. The signal generator unit 30 therefore generates a first stimulation signal 31, which it applies to the LMN at a suitable location by means of a first applicator 33. Furthermore, a second stimulation signal 32 is generated as feedback and delivered by a second applicator 34 to the sensory nerve cell at a suitable location.

[0127] Due to stimulation of only the sequences in the control system of the reflex arc, the muscle is not yet moved because of interrupted conduction to the muscle, although the LMN (optionally new) is active, as desired. As long as the connection between the LMN and the muscle and/or between the muscle spindle and the sensory nerve cell has not been restored, the system will ensure that the muscle, which is normally innervated by the respective reflexive arc, is in fact being moved. This does not ultimately take place for this reason, because other existing reflex arcs, which are in a causal relationship with the movement, are preferably also taken into account (type A motor neurons).

[0128] This is ensured by motion device 20. In order for this to take place in chronological and causal correlation with the sequences controlled by signal generator unit 30, both of them are controlled by an evaluation and control unit 10.

[0129] This causes a third stimulation signal 41 to be sent to the muscle via a third applicator 40 simultaneously with the first stimulation signal 31 or during the movement of the body part based on the activity of the motion device 20. Contraction of the muscle then generates, by means of the muscle spindle, a sensory signal, which may fade out due to the damaged reflex arc that can be replaced by the second stimulation signal 32. However, it also generates all the other signals that are important in the context of other control systems that are not affected. This prevents these secondary dependent control signals from degenerating due to nonuse.

[0130] Regeneration of the corrupted reflex arc can be supported in a positive sense, as described above, by administering certain factors such as messenger substances and/or growth factors. The system takes this into account by having an injector system 50, which can deliver these substances to the suitable site of action. This site of action is to be identified individually.

[0131] Control unit 10 carries out complex functions. The chronological sequence of stimuli and reactions to stimuli in particular are highly individual. The stimuli per se are preferably complex, not just involving short on-off pulses. Instead, additional coded information about the respective nerve cells is transmitted in the signals, e.g., in the case of the signal of the muscle spindle, information about the degree of contraction of the muscle is transmitted. Then, the need for and type of an additional signal to be transmitted are calculated from the LMN from this information.

[0132] This means that the system is preferably capable of adapting to actual situations. This takes place in that it is implemented in the context of a neural network that is capable of learning or a comparable approach to data processing that is capable of learning. To this end, it deposits data in a local memory unit 60.

[0133] The type of motion device 20, with which the movement of the body part is carried out, depends on the degree and type of damage. For example, a suitable orthotic device 130 may be used if it affects an arm or if the paralysis is incomplete. However, it may also be necessary to use an entire exoskeleton in order to be able to learn to walk again in the case of paralysis-induced immobility, for example. Then the exoskeleton and orthotic device are controlled by the control under 10 and the signal unit 30. The movement patterns used in doing so are also stored in the memory unit 60 and are optionally adapted to the respective prevailing situation by means of the neural network that is capable of learning. Modifications in the form of the type and reason are also stored in the memory unit. Because of these mutual dependencies on the orthotic device or the exoskeleton 130, the evaluation and control unit 10, signal generator unit 30 and memory unit 60 are preferably arranged on the orthotic device or the exoskeleton 130 and thus form an independent unit.

[0134] It is possible to access the evaluation and control unit 10 and the memory unit 60 linked to it from external systems via an interface 90. This can take place wirelessly or via a hardwired connection. This enables the data exchange with an external evaluation and control unit 92 and its external memory unit 91. It is possible in this way to retrieve not only data for evaluation purposes from the independent unit but also to transfer data to it, for example, in order to compare and optionally modify the current movement patterns with those of other independent units. It is also possible in this way to implement not only a system capable of learning on the basis of the local prevailing situations but also a system that can take into account the experience of other systems. Multiple systems can form a mutually supportive network in this way, which is even more effective the greater the number of participants.

[0135] Motion devices 20, which comprise the orthotic device or exoskeleton, can be controlled by the evaluation and control unit 10, in that a signal from the evaluation and control unit can be sent to an actuator 24, which moves to parts 21 and 22 of the orthotic device or of the exoskeleton that are movable relative to one another, for example, by means of actuator motors. They also have a motion sensor system 25, with which the positions relative to one another can be detected and transmitted to the evaluation and control unit by means of a first motion sensor signal 26.

[0136] In addition, the motion sensor system 25 is capable of recording the forces and/or torques occurring with the movement and making them available as a second movement signal 28. The combination of the two movement signals can be used to describe the movement that is carried out and compare it with reference data via a comparator unit 120, for example. As a result of this comparison, the evaluation and control unit 10 can perform an evaluation of the signal 29 thereby generated and can respond to it.

[0137] Additional components with which the movement is generated and monitored by also be necessary. For example, in the case of systems which should serve the function of continued movement, it is necessary to be able to determine an absolute position of the entire system in space in addition to the positions of components 21 and 22 relative to one another. The accelerations occurring in walking are also very important and should be detected and included in the calculations.

[0138] To carry this out and then be able to implement it in an exoskeleton, for example, gyroscopic systems 140 and other suitable sensors 141, for example, acceleration sensors, are necessary to stimulate the function of the position and movement system in the human equilibrium organ and to ascertain linear and/or angular accelerations in all directions in space and transmit this information to the evaluation and control unit 10 for evaluation.

[0139] Treatment of paralysis is extremely individual because the anatomical and physiological prerequisites are extremely individual. It is thus necessary for the system to be able to learn the movement patterns, which are to be carried out and which it then must carry out within the context of response to the activities of the reflex arcs. Therefore, the system must have an operating mode, in which the orthotic device or the skeleton can be moved passively, but wherein it generates all the sensor signals and transmits them to the evaluation and control unit. It is possible in this way to generate a sequence of sensor signals, which represent the sequence of a fluid movement to be carried out and can be used as needed to carry out the learned movement by means of the motion device 20. The passive movement process takes place with suitable therapeutic measures, for example, according to the Feldenkrais method and/or the movements of healthy volunteers. These signal sequences are stored in the memory unit 60 as movement patterns.

[0140] The function of the system in the context of therapy consists of assigning nerve impulses originating from the motor cortex or from other parts of the brain responsible for the motor system and optionally having them carried out.

[0141] Like the situation with the reflex arc, it is important that the motor centers in the brain receive feedback about a movement that has been made. This feedback is necessary not only to keep the motion sequence fluid on the basis of the resulting changes in actions but it also serves to receive this important information in the movement memory of how the movement is to be triggered. If this fails to occur, as with current measures, then this could be the reason why or at least one reason why the pure restoration of nerve cells in the spinal cord, regardless of the method, has not yet been as successful as expected. On the other hand, this could also explain why there have been at least partial cures in some individual cases. In these patients, the movement information was evidently still available or could at least be reactivated.

[0142] In a manner similar to maintaining cognitive memory content such as learned knowledge, inasmuch as that which has been learned can be applied or recalled, it is necessary to receive the contents of the movement memory by carrying out the movements stored there. If this is not the case for a long period of time, the memories are deleted, just as is the case with what you learn in school, after it has not been accessed for a long time. The system should preferably have a mechanism for transmitting feedback about a movement initiated to the brain centers involved even in a case of compromised stimulus conduction in paralysis.

[0143] Therefore, the first sensor unit 100, which can detect signals 101 sent from the brain to the spinal cord via the medulla oblongata, then sends them further as detector signals 102 to evaluation and control unit 10, which analyzes the signals on the basis of data D stored in memory unit 60, among other things, and assigns the data to a movement pattern, which is also integrated there and has been learned. ,in response to a clear-cut stimulus from the brain, it can trigger a motion sequence stored in the brain for the orthotic device or the exoskeleton 130. At the same time, a third stimulation signal 41 is transmitted to the skeletal muscle (S) via signal generator unit 30 and applicator 40. This synchronizes stimulation of the activity of the motor part of the reflex arc with the movement to be carried out.

[0144] Feedback to the brain area takes place in the form of a second sensor unit 110, which can detect a signal 111 of an intact sensory nerve SP, the sensor itself MS or an activity of the muscle S and generates a second sensor signal 112, which prompts the stimulation unit 30 by way of the evaluation and control unit 10 to trigger the second stimulation signal 32. This mechanism also synchronizes the movement to be carried out, in this case with the activity of the sensory part of the reflex arc.

[0145] This is not a trivial process because, like leads for brain currents (EEG), the signals from the brain obtained by means of the sensor unit 100 are a mixture of hundreds and thousands of signals of individual first neurons (UMN) and their sensory analogs because the respective nerve fibers usually cannot be addressed directly. The situation is similar for the signals of the sensor unit 110 derived for feedback because, as already explained above, there is not just one source of sensory information for each muscle. Therefore, a self-learning capability of the system and thus at least a portion of the implementation of the evaluation and control unit in the form of a neural networkor something comparableis required.

[0146] It may be helpful to first have a healthy volunteer carry out the movements with the system in the passive mode. The signals 26 to 29 thereby generated by the motion sensor 25 can be related to the signals 101. This helps not only to be able to give feedback to the motor centers of the brain but also to determine the type and chronological sequence of the first stimulation signal 31 and the second stimulation signal 32 which are necessary for stimulation of the reflex arc.

[0147] The neural network can define a basic setting in this way with which the system can operate and which is then adapted subsequently to the respective patient in that the self-learning system recognizes what is needed for adaptation and performs that act. By means of the data exchange 90 with other systems and control units 91 and their memory systems 92, the individual particulars for other patients can then be verified to ascertain whether they could be helpful with the current patientand then to make appropriate corrections.

[0148] It may also be helpful to substantially reduce the number of interfering signals received by the sensor system 100. This can be achieved by stopping superfluous motor activities. This is difficult for a patient who is conscious, but it can be achieved easily if the patient is put in a trancelike state, which is possible through meditation or hypnosis. This state can be detected by using leads to record the brainwaves (EEG) because their frequency and amplitude form a measure of brain activity. A patient can still respond while in a trance state, but brainwaves picked up as theta waves in this condition indicate that most cerebral activity has been stoppedincluding movements. Administering the treatment under hypnosis/meditation thus seems to facilitate analysis of the required signals, at least in a learning phase of the system.

[0149] Hypnosis/meditation is also advantageous for another reason. Learning movements is an unconscious process and is therefore not subject to arbitrary influence. To be sure, movements can be carried out intentionally but this is limited to a higher level of the movement process. Which activities take place at the level of the nerve stimuli, which are to be triggered and when, in which sequence and with which intensity are not factors that are controlled consciously, as is the case for saving the movement pattern resulting therefrom in the movement memory.

[0150] However, there has been good experience in getting a response out of the movement center and optionally modifying it with patients who have lost their mobility due to other causes. Thus, a combination of hypnosis and the Feldenkrais method in patients in whom the motor center in the cerebral cortex had to be removed completely or partially due to tumors yielded amazing results that could not have been achieved by traditional rehabilitation measures. The problems are similar in these patients. To be sure, the reflex arcs that are so important are still functioning in the spinal cord, but new nerve cells had to take over the task of the nerve cells that had been removed in areas of the brain that previously had nothing to do with movement. This is obviously possible and the process seems to be more promising with the use of hypnosis alone than without the use of hypnosis.

[0151] Therefore, part of this system is a detector 70 capable of detecting electrical brain signals, with which it is possible to evaluate the current degree of consciousness and transmit this information by means of a detector signal 71 to the evaluation and control unit 10. This can then perform its movements and activities resulting therefrom as a function of the state of consciousness. It is also conceivable in particular in the learning phase of the system to allow movements only if the patient is hypnotized.

[0152] Various items of information are necessary to correctly reflect the complicated interaction of mutual dependencies and to trigger corresponding activities. In addition, the system must be able to detect and assess the entire range from complete execution of a motion sequence (ideally) on the basis of a brain signal without any other natural activities (condition immediately after the onset of paralysis) up to a strict monitoring function (at the end of treatment). It is therefore necessary for the system to be self-learning.

[0153] Claims 1 through 6 define interfaces between the system and the biological system in the form of applicators 33, 34 and 40, with which it can deliver pulses to this system. Therefore, signals that fail to occur from the reflex arc are simulated, as is also feedback to the brain.

[0154] Claims 16 and 17 define interfaces between the system and the biological system in the form of sensor units 100 and 110, with which pulses can be obtained from the biological system to control the activities. To obtain a complete overview of the current situation, what is missing is sensors within the reflex arc, which notify the system of how little friction there is with the flow of information taking place within this lower level.

[0155] This information is important because it enables the system to make decisions about which partial aspects are to be simulated in the reflex arc (motor, sensory or motor and sensory simulation), to which extent it must be active as dominant, supporting or monitoring and to which extent the two control systems are to be synchronized. Thus, for example, after functional restoration of the reflex arc, there could be a need to continue to send feedback to the brain in order not to forget the old or newly learned movement patternswhich is important in the training phase in particular.

[0156] There is preferably at least one sensor 80, which detects the activity of the nerve cell to be integrated or the regenerating nerve cell and generates a sensor signal 81, which is made available to the evaluation and control unit 10. The number and location of these sensors 80 depend on the respective case individually. If only the motor part is corrupted, it must sit on the LMN at a location that allows an evaluation of whether the cell is viable and can send nerve pulses over an axon. If the sensory part is corrupted, this also applies similarly to the spinal ganglion. Additional locations of such sensors include the muscles and the body part itself for discovering muscle activities.

[0157] Signals generated in this way can also be used for controlling the injector system 50.

[0158] The system according to the invention is not primarily intended to be used as a technical assistant to improve the long-term quality of life. The system has primarily therapeutic importance with the goal of short-term to medium-term avoidance of the system if no further improvement can be achieved by using the system as part of a therapy. In the ideal case, this is the case after achieving complete restoration of function.

[0159] If this is impossible, the individual information (movement patterns) collected by the system as part of the therapeutic measures, can be used to establish simpler embodiments that are optimized individually and are used as technical medical assistants. In this way the exoskeleton or orthotic device can be produced with a complexity that could not previously be achieved and will allow the patient a new quality of life.

[0160] Use of the invention serves the purpose of the most extensive possible restoration of movement abilities lost due to paralysis but also serves the purpose of treatment of incomplete paralysis (paresis, e.g. peroneal paresis=dorsiflexion paralysis). It should make technical aids that have become necessary, such as orthotic devices/exoskeletons, superfluous by leading to independent movement, starting with forced movement thanks to the invention, by training and increasing withdrawal of the self-learning system (assisted movement). In practical terms, this takes place in three phases:

1. Passive Learning Phase

[0161] With the exoskeleton/orthotic device in place, the movements that the patient is supposed to practice are carried out on the patient in a passive operating mode through suitable measures, such as the Feldenkrais method with/without hypnosis. The motion sensor system 25 on the motion device 20 thereby detects the position of components 21 and 22 with respect to one another as well as other changes that occur during the movement, for example, linear acceleration and angular acceleration (cf. FIG. 3), and relays this information as the first movement signals 26 to control unit 10, which evaluates this motion data BD and stores it chronologically as movement patterns BM in data memory unit 60. These patterns represent the joint positions that are possible individually relative to one another and occur in a fluid movement.

[0162] Already in this early phase, it is advisable to transfer this data to the external database 91 via the interface 90 and have it analyzed by the external evaluation unit 92. In this way, the data can be compared with movement patterns obtained from healthy people with natural movements, without having a therapist compel the movement manually. In addition, comparison with data records from other patients is also possible. By comparing all these data records with the data currently transmitted about the patient, it is possible to ascertain correction values, which can be submitted to control unit 10 via interface 90 again to be taken into account.

[0163] The motion data ascertained in this phase also serves as reference data R, with which comparator unit 120 will later compare the second movement signal 28 in an active operating mode and will optionally generate the signal 29.

[0164] In this phase, control unit 10 also detects signals 81 of sensors 80 (cf. FIG. 4). It is possible in this way to ascertain which components of the control system, motor and/or sensory information can be generated naturally at all with movements and what the quality is. It is possible in this way to decide which of the stimulation signals 31, 32 must be generated by the signal generator unit 30 in the later active phase and in which intensity (cf. FIG. 1).

[0165] Finally, in this phase, the signal 101 optionally coming from the UMN is detected by the first sensor unit 100 and transmitted as the first sensor signal 102 to the control unit 10. The situation is similar with the feedback signal 111, which is intended for feedback to the sensory nerve cell in the brain and, present in this way, is detected by means of the second sensor unit 110 and transmitted in the form of the second sensor signal 112 to the control unit 10. In this way, the interaction of the two intermeshing control systems can be detected, and, if necessary, the signal generator unit 30 can generate signals 32 and 41, which are necessary for maintaining the higher-level control system and preserving the movement memory (cf. FIG. 5).

2. Active Learning Phase

[0166] In an active operating mode, the movement patterns determined in the passive learning phase are used, to be carried out either individually or in any context. The sequences to be learned can be repeated as often as desired. They are selected by means of either input devices 11 and output devices 12 (cf. FIG. 4) or triggered by evaluation of signals 101 (cf. FIG. 5), if possible.

[0167] In this phase the invention is used in two ways: [0168] (1) For active, assisted or forced movement where the control unit 10 controls the movement unit 20 and specifically the actuator 24 that moves components 21 and 22 about the joint 23 relative to one another (FIG. 3). In doing so, the data about the motion sensor system 25 is detected and sent back as feedback to the control unit 10 via the first motion sensor signal 26. At the same time the comparative unit 120 is prompted by means of the second motion sensor signal 28 to compare the data with the stored reference values R and to generate a corrective signal 29, if necessary, and relay it to the control unit 10 for evaluation. Changes occurring here in the movement pattern carried out are saved in the memory unit 60 to optionally be forwarded via the interface 90 at the same time or later for evaluation to the external control unit 92, which also stores these patterns in the external memory unit and sends consequences of the evaluation back to the control unit 10. [0169] (2) For active, assisted or forced signal processing of the control systems, wherein, as in the passive learning phase, the motor sensor signals and sensory sensor signals 81 are picked up, if they occur at all, upstream and downstream from the damaged site by means of sensor system 80. Simultaneously with carrying out the movement, now the missing or inadequately manifested stimuli are stimulated by stimulation signals 31, 32 and 41 and fed into the control system with the LMN via applicators 33, 34 and 40 (FIG. 2). By evaluation of the differences in the type and quality of the incoming signals 81 in different runs, the necessity and quantity of stimulation signals 31, 32 and 44 can be influenced. The goal is to be able to do without them in the long run.

[0170] The active learning phase is a cyclic process consisting of carrying out saved movement patterns, the associated movement, detection of the resulting sensor signals, their evaluation and the resulting adaptation of the movement patterns and signals as well as saving them in external data banks. This is concluded when no more adaptations are necessary and the system has all the necessary data. Furthermore it serves analyze the complex patterns, which are detected as the first sensor signal 102 from the first sensor 100 and to filter out the signals which correspond to the triggering of the desired muscle.

[0171] Since this active learning phase comprises a large number of processes, the system learns independently to adjust to the current patient, so that an optimal individual therapy is possible. At the same time, by comparison with similar cases in the external memory unit 91, there may be indications about which additional measures/changes might be appropriate. The change in individual movement patterns as part of an additional passive learning phase during training is also possible because to do so the movement must simply be impressed from the outside (e.g., by means of the Feldenkrais method) (correction and fine tuning).

[0172] All the sequences can be carried out with or without the use of additional measures such as meditation, hypnosis, stem cell therapy, nerve cell transplantation or stimulation of nerve growth. The changes in responses to these measures as well as the findings based on biofeedback all enter into the calculations.

3. Training Phase

[0173] The training phase differs from the active learning phase only in that the system no longer performs changes in the movement/signal patterns. In the training phase the sensor signals 81 are also detected and evaluated but in this phase the evaluation serves only to ascertain to what extent the system can withdraw from the forced operation and subsequently assisted operation. It is terminated when either no stimulation signals 31, 32 and/or 41 are necessary any longer (restitution to original condition), so the patient can move again completely on his own, or the required stimulus quality/intensity can no longer be reduced over a long period of time (residual damage).

[0174] It is also possible to return from the training phase back to the active or even passive learning phase if necessary.

REFERENCE LIST

[0175] 1 nerve conduit

[0176] 2 motor nerve conduction part

[0177] 2 motor nerve conduction part, separated from the skeletal muscle

[0178] 2 motor nerve conduction part, connected to the skeletal muscle

[0179] 3 sensory nerve conduction part

[0180] 3 sensory nerve conduction part, separated from the skeletal muscle

[0181] 3 sensory nerve conduction part, connected to the skeletal muscle

[0182] 4 body part

[0183] 5 separation point, functional interruption in nerve conduction

[0184] 10 evaluation and control unit

[0185] 11 display module

[0186] 12 input module

[0187] 20 motion device

[0188] 21, 22 components

[0189] 23 joint

[0190] 24 actuator

[0191] 25 motion sensor system

[0192] 26 first motion sensor signal

[0193] 28 second motion sensor signal

[0194] 29 correction signal

[0195] 30 signal generator unit

[0196] 31 first stimulation signal

[0197] 32 second stimulation signal

[0198] 33 first applicator

[0199] 34 second applicator

[0200] 40 third applicator

[0201] 41 third stimulation signal

[0202] 50 injector system

[0203] 60 memory unit

[0204] 70 detector unit

[0205] 71 detector signal

[0206] 80 sensor system

[0207] 81 sensor signal

[0208] 90 interface

[0209] 91 external memory unit

[0210] 92 external evaluation and control unit

[0211] 100 first sensor unit

[0212] 101 natural nerve signal intended for stimulation of the skeletal muscle

[0213] 102 first sensor signal

[0214] 110 second sensor unit

[0215] 111 nerve signal of the sensory nerve connected to the skeletal muscle

[0216] 112 second sensor signal

[0217] 120 comparator unit

[0218] 121 optical or acoustic display

[0219] 130 power supply unit

[0220] 140 gyroscope

[0221] 141 acceleration sensors

[0222] S skeletal muscle

[0223] D data

[0224] MS muscle spindle

[0225] R reference data