Neurostimulation system for central nervous stimulation (CNS) and peripheral nervous stimulation (PNS)

Abstract

To provide a neuromodulation and / or neurostimulation system.SOLUTION: The present disclosure relates to a neuromodulation and / or neurostimulation system 10 comprising at least the following components: at least one sensing unit 12, at least one control unit 14, at least one stimulation unit 16, at least one Central Nervous System (CNS) stimulation module 18, and at least one Peripheral Nervous System (PNS) stimulation module 20, wherein at least one of the components of the neuromodulation and / or neurostimulation system is implantable.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an active closed loop medical system, in particular to a spinal cord injury, for example following trauma. Applications for neurostimulation in the field of improving recovery after neurological disorders such as spinal cord injury (SCI) Active closed loop medical system. [Background technology]

[0002] EP 2 868 343 A1 describes the mechanism of locomotion following neuromotor dysfunction. System for delivering adaptive electrical spinal cord stimulation to facilitate and restore motion Among other things, they disclose a closed-loop system for real-time control of epidural electrical stimulation. The system is disclosed for providing neuromodulation (neuromodulation) to a subject using adjustable stimulation parameters. means for continuously receiving a feedback signal from the subject; a real-time monitoring component having a sensor for acquiring a signal, The system is operatively connected to a signal processing device and a frame for providing a characteristic of the subject's motion. It receives feedback signals, runs real-time automatic control algorithms, and The device is operatively connected to the means and is operable to provide new stimulation parameters to the means with minimal delay. This known system improves gait consistency in subjects with neuromotor impairments. Using single-input single-output (SISO) or multiple-input single-output (MISO) models. A real-time automatic control algorithm with a feedforward component is used. Wenger et al., Closed-loop neuromodulation of spinal sensorimotor circuits. ts controls refined locomotion after complete spinal cord injury, in Science Tra See also Journal of Clinical Neurology, vol. 6, num. 255, 2014.

[0003] WO 2002 / 034331 discloses a method for delivering and receiving an implantable medical device. The present invention discloses a non-closed loop implantable medical device system with a signal processing device, The transceiver device communicates with the patient, between the patient and the implantable medical device, and remotely. The location and data are exchanged between the implantable medical device and the transceiver device. The combined communication device communicates with the implantable medical device through a transceiver device and a receiver device. and exchanging data with the medical device and between the transceiver device and the remote location. between the patient, the implantable medical device, the transceiver device and the remote location; Allows bidirectional data transfer. The converter unit converts data from a first telemetry format to a Converting the transmission of data into a second telemetry format, and a user interface for converting the transmission between the receiver device and the patient, and between the implantable medical device and the patient through the transceiver device Information is exchanged between patients and between patients and remote locations via transceiver devices. to be interchangeable.

[0004] US Patent Application Publication No. 2002 / 0052539 discloses a partially closed loop, non-continuous and A non-real-time emergency medical information communication system and corresponding method are described. The system detects the presence of an implantable medical device (IMD) in the patient's body. or to issue emergency alerts based on the information processed. , a communication module located outside the patient's body, a mobile phone and / or a personal digital assistant ( The communication module, mobile phone or PDA can communicate with the IM D to a remote computer via a communication system. Emergency corrective actions can be taken at the remote computer system. In such cases, it may be deemed necessary to remotely control the IMD via a communication system. Actions are executed remotely from the host computer system.

[0005] U.S. Patent No. 7,149,773 describes how medical services are provided to patients automatically. The present invention relates to a method, device and system for dynamically generating invoices. For example, some of the performance of implantable medical devices (IMDs) implanted in patients' bodies may be affected. When monitoring of a patient's condition is initiated by the patient or remotely, or by the patient via an IMD by the system when delivery of treatment to a patient is initiated locally or remotely. The IMD is a communication module located outside the patient's body, a mobile phone and / or a personal digital assistant (PDA) for two-way communication. The system includes an IMD, a communication module and / or a mobile phone and / or a PDA, A means for generating voice, a remote computer system, and a communication device capable of two-way communication. For two-way communication, a communication module, a mobile phone and / or Alternatively, the PDA can receive information from the IMD or relay information to the IMD. It is.

[0006] U.S. Patent No. 6,878,112 discloses a method for detecting a plurality of implantable medical devices (IMDs). Web-based system for remotely monitoring, managing and modifying operational and functional parameters. Multiple cooperating and complementary software programs implemented in a high-speed computer system The system includes a virtual electrophysiology module. Veterinary ophysiologist module (VEM), chronic monitoring module (CMM) and prescription program Specific treatments and treatments for managing IMD are available through the Prophylactic Medicine Module (PPM) program. and diagnostic methods remotely, conditionally and on a real-time basis. Identify critical medical events, determine optimal clinical settings, and optimize performance based on prescription data. By upgrading the IMD parameters, you can remotely and continuously monitor, manage and The module is a high-speed computer that runs in a web-enabled environment. The module and IMD are implemented in a data center having a wireless communication system. communicates through the system via a programmer or an Interface Medical Unit (IMD) .

[0007] European Patent Application Publication No. 2652676 discloses a method for monitoring vital body signs. For gesture control, an accelerometer or a body sensor is used for user control of the body sensor. This reuses the more precisely detected acceleration of the patient, which is independent of the acceleration signal from other movements of the patient. This is achieved by detecting predefined patterns in the sensor. This includes tapping with the sensor, vibration and redirection of the sensor. Reliable gestures without many false positives due to gesture movements A new procedure is described that allows for the reuse of acceleration sensing for detection. A similar solution for detecting tapping of a sensor is described in U.S. Pat. No. 8,326,569. and U.S. Pat. No. 7,742,037.

[0008] Known stimulation systems include central nervous system (CNS) stimulation, in particular epidural electrical stimulation (EES); or using peripheral nervous system (PNS) stimulation, specifically functional electrical stimulation (FES).

[0009] Epidural electrical stimulation (EES) restores motor control in animal and human models. It is known that the neural network responsible for locomotion under spinal cord lesions can be artificially activated. It has been shown in particular to restore locomotion after spinal cord injury by administering osso, M, et al., A Computational Model for Epidural Electrical Stimulation of Sp inal Sensorimotor Circuits, Journal of Neuroscience 4 December 2013, 33 (49) 193 26-19340, Courtine et al., Transformation of nonfunctional spinal circuits into functional states after the loss of brain input, Nat Neurosci. 2009 Oct; 12(10): 1333-1342, Maraud et al, Mechanisms Underlying the Neuromodulation of Spinal Ci rcuits for Correcting Gait and Balance Deficits after Spinal Cord Injury, Neuron Volume 89, Issue 4, p814-828, 17 February 2016). EES directly stimulates motor neurons. Instead of stimulating the afferent sensory neurons directly before they enter the spinal cord, The spinal nerve circuits responsible for locomotion are indirectly reinforced by these afferent nerves ( recruited), and locomotion movements are globally coordinated by activating the necessary muscle synergies. The movements produced are functional but relatively poorly selective (selectively targeting major muscles). The lack of controllability and imprecision due to neural network activation (rather than targeting the target directly) This prevents fluidity and full functionality in the potential space of movement.

[0010] Peripheral nerve stimulation (PNS) systems that have been used in clinical practice to date use surface electrodes. Electrical stimulation of the target muscle by direct stimulation of the muscle or by transcutaneous stimulation of the peripheral nerve This is known as functional electrical stimulation (FES), which delivers Therefore, FES is not suitable for use in daily life. Difficult setup when using stimulation, and lack of selectivity (when using transcutaneous nerve stimulation) Demand for stable and stable operation (when stimulating muscles, clothing, sweat, etc. may cause the electrodes to be The limited success has been due to the inability to move and routinely reproduce precise electrode placement. It becomes something like that. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] European Patent Application Publication No. 2868343 [Patent Document 2] International Publication No. 2002 / 034331 Brochure [Patent Document 3] US Patent Application Publication No. 2002 / 0052539 [Patent Document 4] U.S. Patent No. 7,149,773 [Patent Document 5] U.S. Patent No. 6,878,112 [Patent Document 6] European Patent Application Publication No. 2652676 [Patent Document 7] U.S. Patent No. 8,326,569 [Patent Document 8] U.S. Patent No. 7,742,037 [Patent Document 9] International Publication No. 2016 / 0279418 Brochure [Non-patent literature]

[0012] [Non-Patent Document 1] Wenger et al., Closed-loop neuromodulation of spinal sensorimotor circuits controls refined locomotion after complete spinal cord injury, in Science Translational Medicine, vol. 6, num. 255, 2014 [Non-Patent Document 2] Capogrosso, M, et al., A Computational Model for Epidural Electrical Stimulation of Spinal Sensorimotor Circuits, Journal of Neuroscience 4 December 2013, 33 (49) 19326-19340 [Non-Patent Document 3] Courtine et al., Transformation of nonfunctional spinal circuits into functional states after the loss of brain input, Nat Neurosci. 2009 Oct; 12(10): 1333-1342 [Non-Patent Document 4] Maraud et al, Mechanisms Underlying the Neuromodulation of Spinal Circuits for Correcting Gait and Balance Deficits after Spinal Cord Injury, Neuron Volume 89, Issue 4, p814-828, 17 February 2016 [Non-Patent Document 5] X. Navarro, et al., A critical review of interfaces with the peripheral nervous system for the control of neuroprostheses and hybrid bionic systems, J. Peripher. Nerv. Syst. 10 (3) (2005) 229-258 [Non-Patent Document 6] K. Yoshida, K. Jovanovic, RB Stein, Intrafascicular electrodes for stimulation and recording from puppy mud spinal roots, J. Neurosci. methods 96 (1) (2000) 47-55 [Non-Patent Document 7] J. Badia, et al., Comparative analysis of transverse intrafascicular multichannel, intrafascicular and multipolar cuff electrodes for the selective stimulation of nerve fascicles, J. neural Eng. 8 (3) (2011) 036023 Summary of the Invention [Problem to be solved by the invention]

[0013] The object of the present invention is, for example, to provide a method for the treatment of neurological disorders in a more individualized manner, adapted in particular to the needs of the patient. The device is also suitable for use in treating spinal cord injury, for example after trauma, in that it can provide conditioning and / or neurostimulation. Improve recovery after neurological disorders such as spinal cord injury (SCI), as well as patient rehabilitation Provide patients with the training and necessary assistance in daily life, adapted to their progression The objective of the present invention is to provide an improved neurostimulation system in the field of application. [Means for solving the problem]

[0014] This object is achieved by a method for the neuromodulation and / or neurostimulation of a subject having the features of claim 1. The solution according to the invention is provided by a thermal imaging system comprising at least the following components: , at least one detection unit; at least a control unit; - at least one stimulation unit; - at least one central nervous system (CNS) stimulation module; - at least one peripheral nervous system (PNS) stimulation module; In particular, at least one of the components of the neuromodulation and / or neurostimulation system A neuromodulation and / or neurostimulation system, one of which is implantable, is provided.

[0015] The present invention relates to a method for providing neuromodulation and / or neurostimulation to the central nervous system (CNS) using a system. The basic idea is that it is possible to deliver a therapeutic agent to the peripheral nervous system (PNS). Both the CNS and PNS can be stimulated simultaneously or intermittently or can also be stimulated on demand. These strategies can be combined and made available to equipped patients. For example, Neuromodulation and / or neurostimulation of the CNS are used to enhance a patient's ability to move. This can be achieved by, among other things, restoring or restoring the function of the device, depending on command signals for body movements, etc. It is still provided by the patient's nervous system and is simply supported by the CNS stimulation module. and / or enhance or transform the transmission of physiological signals within the patient's body. This is done in such a way that existing methods are supported. to trigger specific movements and / or improve existing movements using stimulation Stimulation signals can be manipulated locally and directed to specific peripheral nerve structures. S-stimulation is used to improve the motor and / or movement capabilities of patients wearing the system. For example, but not by way of limitation, this can be used to perform a procedure on a patient's leg. To complete the bending, extension, lifting, turning, etc. of a finger, arm, foot, leg, or any extremity. This can be achieved, for example, by using the neuromodulation and / or stimulation provided by the CNS stimulation module. or the perception that the neurostimulation is not sufficient to allow the patient to complete the movement or intended state. Such movements or intended states are then monitored by the PNS stimulation system. It can be completed or supported by the stimulus provided by the system. NS stimulation can also be used to reduce side effects and compensate for imprecision in CNS stimulation.

[0016] Such a combination of CNS and PNS stimulation allows for individualized stimulation of the patient. It can provide stimulation and treatment.

[0017] The system may be fully implanted, partially implanted, or have virtually no invasive components. This can be provided solely by the component.

[0018] The system may be used for, but is not limited to, restoring or training patient movement, locomotion, wakefulness, and other activities. Patients such as standing and / or walking, reaching and / or grasping, blood pressure and / or pulse related to cardiovascular signals, tension, nerve stimulation, e.g. vagus nerve stimulation, improving the patient's immune system, body temperature, etc. It can also be used to improve the patient's overall well-being. The therapeutic effects (e.g., pain management) can also be improved.

[0019] The central nervous system (CNS) stimulation module is an epidural stimulation device that can deliver epidural stimulation. module, and / or a subdural stimulation module capable of providing subdural stimulation; and / or an intracortical stimulation module capable of providing intracortical stimulation; It may be an intrathecal stimulation module capable of providing intrathecal stimulation or It can be provided with:

[0020] In particular, the epidural stimulation module is an epidural electrical stimulation (EES) neurostimulator element. It is possible.

[0021] EES does not directly stimulate motor neurons, but stimulates afferent sensory neurons before they enter the spinal cord. In this way, the spinal cord circuits responsible for locomotion stimulate these afferents. It is indirectly reinforced by the stimuli of the nervous system and activates the necessary muscle synergies to promote locomotion. Movements are restored globally. The generated movements are functional, but have relatively poor selectivity (mainly Instead of selectively targeting the muscles that are important for the exercise, the controllability is reduced due to activation of neural networks. Imprecision impedes fluidity and full functionality in the potential space of movement. .

[0022] In relation to locomotion, proprioceptive afferents are stimulated more selectively, resulting in walking cycles. When combined with different stages of the process, EES can be used to further improve effectiveness. This can further improve the effect of training. The phase consisted of alternating stimulation of the extensor and flexor muscles of the right versus left leg. Both the leg phase (flexion) and the weight-bearing stance phase (extension) can be restored. In contrast, continuous EES may interfere with the limbs.

[0023] In particular, the epidural stimulation module (the epidural electrical stimulation (EES) neurostimulator element) Using real-time motion feedback input as part of a closed-loop medical system It is designed to function based on a time-critical stimulation algorithm coordinated in a "loop" fashion. The present invention can be arranged and configured as a spatially selective spinal implant.

[0024] The Peripheral Nervous System (PNS) Stimulation Module provides Functional Electrical Stimulation (FES) of the peripheral nerves and Providing electrical stimulation, thereby enhancing selective refinement to generated movements The present invention may be a functional electrical stimulation (FES) module capable of:

[0025] During peripheral nervous system (PNS) stimulation, efferent motor neuron axons, and therefore muscles, are straightened. The spinal cord is connected to the brain and receives stimulation from a complex network of neurons. (X. Navarro, et al., A critical review of interfaces with the periphery l nervous system for the control of neuroprostheses and hybrid bionic systems, J Peripher. Nerv. Syst. 10 (3) (2005) 229-258), invasiveness, selectivity and reliability Intraneural implants are more effective than extraneural or epimysial implants. Providing superior stimulation selectivity, increased signal-to-noise ratio of recordings, and lower activation thresholds Therefore, it is the most suitable implant (K. Yoshida, K. Jovanovic, RB Stein, Intrafo ascicular electrodes for stimulation and recording from mud puppy spinal roots, J. Neurosci. methods 96 (1) (2000) 47-55;J. Badia, et al., Comparative analysis of transverse intrafascicular multichannel, intralongitudinalfascicular and mul tipolar cuff electrodes for the selective stimulation of nerve fascicles, J. neu ral Eng. 8 (3) (2011) 036023).

[0026] Peripheral nerve stimulation with intraneural electrodes provides direct and precise local control. However, artificial stimulation induces muscle tension through an unnatural reinforcement sequence of neurons. In fact, the larger diameter neurons, and therefore the The muscle fibers are reinforced by artificial electrical stimulation, while the afferent fibers are stimulated by spinal cord stimulation. reinforce afferent fibers before they enter the intracellular network, thereby enhancing the natural reinforcement of motor neurons. In contrast, they provide extremely tight and localized control. During the study, PNS stimulation resulted in rapid fatigue of the usual tasks, leading to increased fiber type excitation. conditions arise that are a major limitation to the functional use of this fiber type.

[0027] Thus, intraneural peripheral nerve stimulation is advantageous in terms of increased selectivity, stability, and reduced cumbersomeness. Such a system is very good at dealing with the demands of a single neural impulse. The architecture of the peripheral nervous system allows the nervous system to The fiber bundles in the septum are interfaced proximally with multiple channels, allowing for more distal By selectively stimulating the fibers that innervate the muscles, multiple agonist and antagonist muscles can be stimulated. These types of implants are well anchored within the nerve. This provides stability.

[0028] Intraneural PNS stimulation allows direct targeting of specific muscles, expanding the reachable space of movement However, the intraneuronal PNS can induce selective and controllable activation of Stimulation reinforces motor axons and induces higher muscle fatigue compared to spinal cord stimulation, so any In addition, the nerve-to-nerve coupling is not efficient enough to generate strong, consistent movement at the same time. The extreme selectivity afforded by direct projections to muscles innervated by the fasciculus allows for functional, load-bearing movements. In fact, functional, multi-joint movements are controlled by more than one nerve. It requires the reinforcement of muscles that are stimulated, and stimulating one nerve is not enough to produce useful movement. Not minutes.

[0029] Thus, both CNS, e.g., EES, and PNS, e.g., FES, stimulation types The combination of these two paradigms leverages the advantages of each and allows for the development of functional, complex and sophisticated neuronal systems after paralysis. Targeting the central and peripheral nervous systems is complementary and functional. Allows for restoration of active, weight-bearing movement.

[0030] Intraneural peripheral nerve stimulation has several advantages in terms of increased selectivity, stability, and reduced cumbersomeness. Such a system certainly meets the above-mentioned demands because it is The architecture of the peripheral nervous system allows The fiber bundles in the septum are interfaced proximally with multiple channels, allowing for more distal muscle By selectively stimulating the fibers that innervate the meat, multiple agonist and antagonist muscles can be targeted. These types of implants are well anchored in the nerve. , thus providing selectivity and stability. However, direct reinforcement of motor axons also It induces high muscle fatigue compared to muscle stimulation, so it is powerful and coherent at any time. However, it is not efficient enough to generate the desired motion.

[0031] The more recently discovered indirect EES method is built on a strong scientific foundation and is Although it has the potential to overcome most of the inherent limitations of There is a lack of extensive clinical experience.

[0032] The central nervous system (CNS) stimulation module is at least partially implantable or or at least partially embedded in the CNS stimulation module. The system can then be used to provide highly effective This allows more effective treatment to be given to patients.

[0033] The peripheral nervous system (PNS) stimulation module is at least partially implantable or Generally speaking, the PNS stimulation module may be embedded in the The device may not be implanted, but simply attached in an appropriate manner to the patient's skin. Nevertheless, by implanting a PNS stimulation module, stimulation The module can be placed close to the target structure to be stimulated. The integrated PNS stimulation module allows for more selective stimulation.

[0034] The components of the neuromodulation and / or neurostimulation system may be, for example, a closed loop system. It can be formed.

[0035] A closed loop system is formed in which the control unit receives input from the sensing unit. Such input can be, for example, a patient (i.e., neuromodulation and / or Related to physiological signals, such as physiological electrical signals from a patient equipped with a neurostimulation system The physiological sensations given by the patient stimulated by the system can be By using feedback, stimulation can be better adapted to the patient's needs. Such physiological signals may include, but are not limited to, the patient's gait cycle, locomotion, standing, and / or the patient's cardiovascular signals, such as gait, blood pressure and / or pulse, tension, nerve stimulation Stimuli, such as vagus nerve stimulation, signals directly or indirectly related to the patient's immune system, temperature, etc. Based on this signal, the controller may control the stimulation. Controls the unit, which in turn controls the CNS stimulation module and the PNS stimulation module The CNS and PNS stimulation modules can be used to stimulate the required neuromuscular system. These signals and the patient's physiology can provide neurostimulation signals. The response of each sensor can be detected by a detection unit, and the respective sensor signal can then be expressed as: This can be used as a further basis for the control provided by the control unit. This provides a closed loop system.

[0036] The components of the neuromodulation and / or neurostimulation system form an open loop system. In that case, the required systems and electronic components can be less sophisticated. This eliminates the need for a more cost-effective system. It reduces complexity, which makes the system more reliable with less effort. In particular, in the case of an open loop system, it may be possible to, for example, Protocols and settings can be provided to the patient. If changes are required, such changes , by upgrading or installing additional stimulation routines into the system. This allows a very simple system layout to be achieved using the open-loop approach. It is possible.

[0037] Furthermore, the control unit may be configured such that the control occurs in real time. In particular, real-time refers to a delay between the detection signal and the applied stimulus signal of more than 30 ms. This can be understood as not being a problem, as described in International Publication No. WO 2016 / 027941. This has already been mentioned in pamphlet No. 8.

[0038] Real-time control in the sense of the present invention and its preferred embodiments, i.e. in particular detection It is important to note that the delay between the detection signal and the stimulus signal given should not exceed 30 ms. The system is advantageous for the group approach and for the closed loop approach. For the patient, stimulation can be provided at or near the time when progress is required, e.g., with the desired movement. It is very helpful to do so.

[0039] Additionally, the peripheral nervous system (PNS) stimulation module can stimulate the brain in or against surrounding structures. The device has at least one electrode having at least one fixing element for fixing the electrode. This allows the positioning of the electrodes of the PNS stimulation module to be adjusted to the or near the structure that is to be stimulated by the PNS stimulation module. It is possible to keep it.

[0040] Further, the control unit is configured to: , stimulation provided by the PNS stimulation module and / or the CNS stimulation module The stimulus given by - The control unit controls the PNS stimulation module and / or the CNS stimulation module. The stimulation control signal provided to control the device is retrieved from the subject's brain and / or nervous system. The subject's intention to move is at least partially aligned with a physiological signal associated with the subject's intention to move. to, and / or - The control unit controls the PNS stimulation module and / or the CNS stimulation module. The stimulation control signal provided to control the ball is at least partially aligned with the desired kinematic trajectory. and / or - The control unit controls the PNS stimulation module and / or the CNS stimulation module. The stimulus control signal provided to control the surface on which the subject is located or the surface on which the subject is placed is and / or to at least partially match a desired force against the surface being touched. Or, - The control unit controls the PNS stimulation module and / or the CNS stimulation module. The stimulation control signal provided to control the gripping motion is a constant gait pattern and / or a constant gripping motion. to at least partially align with muscle activation for type and / or movement; It can be configured to be adjustable and / or adaptable.

[0041] By tailoring the stimulation control signals, it is possible to provide very specific neuromodulation or stimulation. Furthermore, it is possible to obtain a motion-related signal associated with the subject's intention to move, which is decoded from the brain and / or nervous system. Very precise neuromodulation or neurostimulation by detecting physiological signals and trigger sensing, allowing the system to provide highly accurate neuromodulation or neurotransmission. Stimulation can be delivered by aligning the stimulation control signals relative to the desired kinematic trajectory. This allows the correction of unwanted signals and allows the intended movement to be performed in an individually tailored way. In addition, the PNS stimulation module and / or the CNS stimulation module may be A stimulus control signal for controlling the module is generated based on the intended force of touch by the subject. Such support can be tailored to the patient's needs and the forces required. It can be linked to the control of standing and walking, or hand or arm movements. Detect muscle activation for patterns and / or grip types and / or movements and activate The stimulation control signals may also be coordinated with physiological signals to activate and control the stimulation. Specific physiological trigger signals for such gait patterns or grip types and movements By finding the right treatment, the system can provide the best possible treatment for your condition through neuromodulation and / or neurostimulation. can provide specialized support to

[0042] Further, the control unit is adapted to receive a signal provided by the sensing unit and related to the movement of the subject. In particular, the motion and / or force of the subject and / or the The system can then continuously decode signals related to EMG activity and / or kinematic trajectories. The present invention may be configured to enable a physiological signal associated with the subject. There may be an interaction of stimuli. This interaction of stimuli and physiological signals to individualize the neuromodulation or neurostimulation provided by the system. In particular, sustained or transient stimulation can be provided by the CNS stimulation module. There can also be transient stimulation in the PNS neurostimulation module. , which can be triggered by a trigger event. Such a trigger event is , which may be provided by a sensing unit, such as an EEG or EMG or force signal. It may be possible to use cortical signals, or from voice control or movement signals, etc. Here, an accelerometer, a force sensor, an interactive sensor or further can use external sensors such as a microphone for voice control. A camera or the like can also be used to provide a signal for the stimulation control signal. To do this, there can be a stimulus interaction, and the trigger event is a specific behavior. It can be a force or EMG profile, and CNS and PNS stimulation It can be triggered by a continuous, transient, or any other signal. Cut.

[0043] The control unit controls the stimulation provided by the PNS stimulation module and the CNS stimulation module. The stimulation provided by the modules may be arranged to be at least partially alternating. Yes, this specific stimulation can support the patient's motor output.

[0044] Further, the control unit controls the stimulation provided by the PNS stimulation module and the CNS stimulation module. so that there may be at least partial overlap with the stimuli provided by the modules. This can improve the effectiveness of the stimulation.

[0045] Thus, the control unit may be configured to control the PNS stimulation module or the CNS stimulation module. The stimulation provided by one stimulation module is then fed back by another stimulation module to improve motor output. The method may also be configured to be used at least in part for correction of the stimulation that is applied. Such techniques are used to support movements, correct the movements themselves and specific movements, The patient can be assisted in movement.

[0046] The control unit independently controls the PNS stimulation module or the CNS stimulation module. , may be able to be switched on and off. This allows for CNS stimulation or It is possible to provide only PNS stimulation. Such functionality of the system can be achieved by using the system. Depending on the condition of the subject equipped with the system, Stimuli can be tailored to specific needs.

[0047] Furthermore, the present invention relates in particular to a neuromodulation and / or neurostimulation system as described above. By using the system, central nervous system (CNS) stimulation combined with peripheral nervous system (PNS) stimulation can be achieved. The present invention relates to a method for providing neuromodulation and / or neurostimulation by providing stimulation to the brain.

[0048] Additionally, in the context of the present disclosure, central nervous system (CNS) stimulation in combination with peripheral nervous system (PNS) stimulation is Patent claims for providing neuromodulation and / or neurostimulation by providing NS stimulation Use of the neuromodulation and / or neurostimulation system according to any one of claims 1 to 14 It will be disclosed.

[0049] In relation to peripheral nervous system (PNS) stimulation, stimulation of the upper limb nerves, i.e. radial, ulnar, Stimulation of the median and / or transverse nerves can be given. Similarly, in conjunction with PNS stimulation , stimulation of the lower limb nerves such as the sciatic nerve and / or femoral nerve. PNS stimulation can be achieved using intraneural electrodes (transverse or longitudinal) or epineural (cuff) electrodes. This can be done by targeting one of the nerves mentioned above.

[0050] In relation to central nervous system (CNS) stimulation, the following neural structures can be stimulated: For movement, the cervical spinal cord or hand / arm motor cortex is stimulated by the CNS stimulation module. For lower limb movements, the lumbosacral spinal cord or the lower limbs can be stimulated. All these nerves can be targeted by epidural, subdural or intrathecal / intracortical stimulation. can be done.

[0051] The sensing module consists of one (surface or intramuscular EMG electrode, one for constructing the control signal) or by some electrodes) to sense muscle activation. The system can sense the kinematics of the patient through variables such as IMUs. The force exerted by the subject, or the force intended to be exerted by the subject, may be measured using, for example, an insole on the foot. Or there may be some sensors that detect pressure in the glove. Such sensors can also be wearable. EEG, ENG, ECoG ,field potentials, ,obtained by intracortical electrode arrays, patch clamp electrodes, or single penetrating electrodes,. It is possible to detect neural signals such as multi-unit and single spikes.

[0052] Both stimulation units can use a common IPG, which can be used to stimulate the CNS. It can provide the stimulation currents and signals required by the module and the PNS stimulation module. Also, one IPG for the PNS stimulation module, and one IPG for the CNS stimulation module It is also possible that two separate IPGs are provided, one for the 1st and 2nd IPGs, one for the 2nd and 3rd IPGs, one for the 3rd and 4th IPGs, one for the 4th and 5th IPGs, one for the 5th and 6th IPGs, one for the 6th and 7th IPGs, one for the 8th and 9th IPGs, one for the 1st and 2nd IPGs, one for

[0053] Stimulation parameters for peripheral nervous system (PNS) stimulation and EES stimulation are frequency, amplitude , pulse width, etc.

[0054] A suitable frequency range is, for example, about 30 Hz to 120 Hz.

[0055] The amplitude value can be selected from 20 μA to 1000 μA.

[0056] The pulse width value can be selected from 0.040 msec to 1 msec. The parameters are 50μA for amplitudes with pulse widths of 40μsec to 120μsec. It is in the range of ~300μA.

[0057] The above values ​​of amplitude and pulse width depend, inter alia, on the interface used and on the For example, intraneural electrodes are more invasive than, for example, epineural cuffs ( Both can be used in the system, so that the stimulation charge required to reinforce the axon is For these intraneural electrodes, this total injected charge per stimulation pulse (charge = amplitude × pulse width) should not be higher than 120nC (a limitation of the electrode itself, not the tissue - Within this constraint, the amplitude can be between 20μA and 1000μA. The pulse width can be set to 0.040 msec to 1 msec. For amplitudes with pulse widths of 40μsec to 120μsec, It is in the μA range.

[0058] EES can be transient or sustained, while selective PNS is always transient. Transience refers to the occurrence of a defined event in the detection signal (decoded intent, consecutive decodes, onset of activation, onset of movement), and defined events during movement (e.g. foot release during walking, The term is defined as being fixed to the ground (either the ground or the foot).

[0059] In relation to the closed loop system, the following functioning scheme is performed by the entire system:

[0060] Based on the sensed signal, stimulation in the PNS and / or CNS is performed in real time. - to align with the intent decoded from the brain, and / or - to continuously decode the motion, force or EMG from the signals, and / or - to conform to a predetermined kinematic trajectory, and / or - to match the desired force to the softness of the surface (of the ground or the grasped object); and / or - To align muscle activation for a given gait pattern / grasp type can be adjusted.

[0061] Further details and advantages of the invention will now be disclosed with reference to the drawings. [Brief description of the drawings]

[0062] [Figure 1] 1 is a schematic diagram of a layout of an embodiment of a neuromodulation and / or neurostimulation system according to the invention. [Diagram 2] 1 is a schematic diagram of an implantable system and a subject wearing the system. [Diagram 3]1 is a schematic overview of a feasibility study performed on rats showing an example of a system for targeting lower limb movements according to the present invention. [Figure 4] FIG. 1 is a further schematic overview of a feasibility study carried out on a rat, showing an example of how CNS and PNS stimulation can be used based on the sensory signals recorded in the framework of restoring lower limb movement, for the system and method according to the present invention. [Diagram 5] 1 is a further schematic overview of a feasibility study performed with rats providing proof of concept of the system and method according to the present invention. [Figure 6] FIG. 13 is a further diagram of the walking patterns generated by CNS stimulation under the EES only form, as well as by combined PNS and CNS stimulation, where the PNS locally refines the generated patterns depending on the frequency of PNS stimulation used, illustrating the efficiency of the system for restoring improved lower limb movement according to the present invention. [Figure 7] 1 is a flow chart illustrating an example of how an embodiment of the present invention of a neuromodulation and / or neurostimulation system operates. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0063] FIG. 1 shows a schematic layout of a neuromodulation and / or neurostimulation system 10 according to the present invention. Shown in a simplified diagram.

[0064] The system 10 comprises several components, including a sensing unit 12 and a control unit 14, a stimulation unit 16, a central nervous system (CNS) stimulation module 18, and a peripheral nervous system (PNS) stimulation module 20.

[0065] The stimulation unit 16 includes an implantable pulse generator for the CNS stimulation module 18. The device includes an IPG 22 for stimulating the PNS and another IPG 24 for stimulating the PNS.

[0066] Only one for both the CNS stimulation module 18 and the PNS stimulation module 20 An IPG may also be provided.

[0067] The system 10 is at least partially implantable, but also includes a sensor, the sensor being It is not embedded, but is connected via wires to a connector and then to the recording chamber, or connected to the control unit 14 by a wireless data transmission link (see FIG. 2).

[0068] As can be seen in FIG. 2, the detection unit 12a and These sensing units 12a, 12b monitor and detect physiological signals. and a sensor for detecting the same, which is a detection electrode in this case.

[0069] The control unit 14 is also implanted in the patient P. This control unit can be It is also possible.

[0070] The control unit 14 comprises at least one memory M.

[0071] This memory provides storage for data and, among other things, control of the system 10. Provides control instructions for

[0072] Such instructions include, but are not limited to: - by the control unit 14, the PNS stimulation module 20 and / or the CNS stimulation The stimulation control signal provided to control module 18 is coupled to the subject's brain and / or How to match physiological signals related to the subject's intention to move, decoded from the nervous system and / or - by the control unit 14, the PNS stimulation module 20 and / or the CNS stimulation The stimulus control signals provided to control the module 18 are then adjusted to correspond to the desired kinematic trajectory and and / or - by the control unit 14, the PNS stimulation module 20 and / or the CNS stimulation The stimulus control signal provided to control the module 18 is applied to the surface or how to match the desired force to the surface the subject is touching, and / or Or, - by the control unit 14, the PNS stimulation module 20 and / or the CNS stimulation The stimulation control signal provided to control the module 18 is based on a certain walking pattern and and / or how to align with the muscle activation for the grip type and / or movement.

[0073] These instructions can be part of a control routine or control software. , can be stored as separate software modules or as instruction data. The data can be stored in memory.

[0074] The link between the sensor signals and the instructions is stored in a memory M, for example in a metadata memory portion or This is achieved by providing metadata for each of them that is stored separately in storage. It is possible.

[0075] A CNS stimulation module 18 and a PNS stimulation module 20 are also implanted in the patient P.

[0076] To this end, each IPG 22 and 24 is also implanted in the patient P.

[0077] However, instead of being implanted, it is attached to the skin of patient P and configured as a wearable device. There are also sensors 12c and 12d that can be attached to the skin. These can be glued or attached as gloves. The device can be attached to the skin of the patient P by, for example, attaching it to the skin of the patient P (see 12c).

[0078] The central nervous system stimulation module 18, in the embodiment shown, provides epidural stimulation via electrodes 25. This is an epidural stimulation module that can deliver stimulation to the spinal cord.

[0079] Typically, the central nervous system stimulation module 18 is a subdural or intracortical or intrathecal stimulation module. It may also be provided as a stimulation module capable of delivering stimulation.

[0080] The PNS stimulation module 20 is capable of providing electrical stimulation of peripheral nerves via electrodes 26. It is a functional electrical stimulation module that can

[0081] As can be seen in FIGS. 1 and 2, the PNS stimulation module 20 It has 26 poles.

[0082] The electrode 26 is implanted, and a fixation element for anchoring the electrode 26 to the surrounding structure at the implantation side. has.

[0083] The control unit 14 receives signals from the various sensors of FIGS. 1 and 2 and 2, various actuators are used to control the received signals and the stored signals in the memory of the control unit 14. The stimulation parameters are adjusted based on the received instructions.

[0084] The control unit 14 controls the detection of the detected signal provided and acquired by the detection unit 12. 20 and / or CNS stimulation module 21. The stimulation provided by Rule 18, - by the control unit 14, the PNS stimulation module 20 and / or the CNS stimulation The stimulation control signal provided to control module 18 is coupled to the subject's brain and / or to match physiological signals related to the subject's intention to move as decoded from the nervous system. 1, - by the control unit 14, the PNS stimulation module 20 and / or the CNS stimulation Aligning the stimulus control signals provided to control the module 18 with the desired kinematic trajectory And to make - by the control unit 14, the PNS stimulation module 20 and / or the CNS stimulation The stimulus control signal provided to control the module 18 is applied to the surface or to match the desired force on the surface the subject is touching, and - by the control unit 14, the PNS stimulation module 20 and / or the CNS stimulation The stimulation control signal provided to control the module 18 is based on a certain walking pattern and and / or to align with muscle activation for grip type and / or movement. It is configured to be adjustable and / or adaptable.

[0085] Furthermore, the control unit 14 is provided with a signal related to the subject's movement, which is provided by the sensing unit 12. In particular, the motion and / or force of the subject can be detected so as to be able to decode the signal corresponding to the motion and / or force of the subject. and / or EMG activity and / or kinematic trajectory related signals are sequentially decoded. The present invention is configured to allow the

[0086] The system 10 functions in real time as a closed loop system.

[0087] In particular, the CNS stimulation module 18 and its electrodes 25, as well as the PNS stimulation module 20 and its electrodes 26 provide a stimulation signal to the sensing unit and sensor 12. , 12a, 12b, 12c, 12d, along with the patient's respective responses, and will be done.

[0088] Typically, system 10 is an open-loop system and functions as an open-loop system. In particular, a pre-programmed sequence of stimuli to achieve a desired exercise result is also possible. It is also possible that there may be sets or patterns.

[0089] In particular, the sensed signal is used to affect the stimulation signal, and the stimulation signal and its physiological response are The reaction is again detected by the detection unit 12 and again influences the control unit 14 .

[0090] This function is implemented in a control unit 14, which is arranged so that the control takes place in real time. It is controlled by this.

[0091] The real-time control and functionality of the system 10 allows control to be performed with minimal delay, i.e. This means that it takes place within a range of approximately 0ms to 30ms.

[0092] The control unit 14 controls the stimulation provided by the PNS stimulation module 20 and the CNS stimulation module 22. configured to at least partially alternate with the stimulation provided by the stimulation module 18. will be done.

[0093] The control unit 14 also controls the stimulation provided by the PNS stimulation module 20 and the C The stimulation provided by the NS stimulation module 18 is at least partially overlapped with the stimulation provided by the NS stimulation module 18. It can be configured as follows.

[0094] Stimulation in an individualized way by alternating or overlapping signals is possible.

[0095] Furthermore, the control unit 14 may be configured to control a PNS stimulation module 20 or a CNS stimulation module 1 8 may be coupled to other stimulation modules to improve motor output. It is adapted to be used at least in part for the correction of the stimulation effect provided.

[0096] Furthermore, the control unit 14 may be configured to control a PNS stimulation module 20 or a CNS stimulation module 1 8 can be independently controlled and switched on and off. The S stimulation module 20 and the CNS stimulation module 18 can be controlled independently of each other. can be done.

[0097] Such control is performed by the control unit 14.

[0098] The functionality of the system 10 can be described as follows.

[0099] The system 10 is an improved neuroprosthetic system for addressing neuromotor disorders. Targeting both the central and peripheral nervous systems in aesthetic rehabilitation. A novel electrical stimulation paradigm for recovery or providing precise and controllable motor function. As explained above, spinal cord stimulation or neurostimulation is not used alone, but rather, central nervous system ( By combining electrical stimulation of the spinal cord with intermittent electrical stimulation of peripheral nerves in real time, , a specific, more general stimulation approach can be established.

[0100] It is possible to take advantage of the complementary advantages of both stimulation types.

[0101] For healthy individuals, motor output is generated by a combination of peripheral (e.g. proprioceptive, sensory, visual...) It is constantly being refined and adjusted based on information.

[0102] To achieve such fine tuning, the stimulation paradigm is a central stimulation paradigm. Selectively strengthening certain muscles to compensate for inaccuracies in the motor output generated by the It is necessary to do so.

[0103] The system 10 may be configured with a CNS stimulation module 18 or a PNS stimulation module 20. , information from the peripheral and central nervous systems to refine and adjust the required stimulation output. can be used.

[0104] For this reason, there exists a combination of spinal cord and peripheral nerve electrical stimulation. Together, these results in highly improved and much more efficient neuroprosthetic rehabilitation of motor control. The results provide a potential application in both paraplegic and paraplegic frameworks. It has an attitude.

[0105] In the paraplegic framework, spinal cord stimulation reinforces the functional circuitry beneath the lesion and provides functional movement. Activate muscle synergies that act as building blocks for movement. While the movements that result from activation of the G are powerful, the control and execution of precise movements This is a challenging task, and the generated motions and their inaccuracies can cause a lot of confusion in the potential space of motions. Fluidity and full functionality in the fluid is impeded.

[0106] Peripheral nerve stimulation allows the direct targeting of specific muscles to expand the reachable space of movement. It can cause selective and controllable activation of the nerves, which allows This extreme selectivity bottleneck caused by direct projections to the muscles involved is a functional, load-bearing In fact, functional multi-joint movements are not possible in two ways. It is necessary to strengthen the muscles controlled by more than one nerve, and stimulating one nerve is not sufficient to generate useful motion.

[0107] Therefore, by combining both stimulation types, the advantages of each stimulation paradigm can be exploited. It can be used to restore functional, complex and precise movements following paralysis.

[0108] As shown in Figures 3, 4, 5 and 6, the feasibility of the above paradigm is This has been demonstrated in a rat model of paralytic spinal cord injury.

[0109] Figure 3 shows a rat model of a mouse model of a rat ... FIG. 1 is a schematic diagram of an example of the implementation of the system 10' in a feasibility study conducted using the test 100. show.

[0110] Similar practices are possible in other mammals or in humans.

[0111] The structure and function of the rat are as described above, but the size of the rat is adjusted to that of the rat. There is an aligned CNS stimulation module 18' and a PNS stimulation module 20'.

[0112] In this example, the spinal cord 102 of a rat 100 was examined using a mouse model that had undergone either severe spinal cord contusion or complete spinal cord transection (Figure 1). The patient was injured at the mid-thoracic level (approximately T8 / T9) by either There are.

[0113] The EMG signal from the ankle muscle 104 was recorded by a nerve polyimide multi-channel implanted in the muscle. The recording is performed via a bipolar wire electrode 106 of a channel implant 107 (see the right side of FIG. 3). See bottom and top left parts).

[0114] The kinematics of the lower limb joints were recorded by the recording system 101, which was glued to the joints with double-sided tape. The reflective markers were used to record the CNS stimulation, which was placed at levels L2 and S1, respectively. The epidural lumbosacral spinal cord 1 is connected to two monopolar wire electrodes 108, 110 (see the upper right part of FIG. 3). Given above is 02.

[0115] 5HT7, 5HT2 and 5HT1a can be used to support stimulation Represents a drug.

[0116] The recorded signals were used to measure the kinematics of the lower limb segments (i.e., stance, swing and drag). ag)) as follows: - the crest, i.e. the kinematic crest signal K1, - hips, i.e. the kinematic hip signal K2, - the knee, i.e. the kinematic knee signal K3, the ankle joint, i.e. the kinematic ankle joint signal K4, and - Foot, i.e. the kinematic foot signal K5.

[0117] Additionally, the recording system 101 records EMG activity. EMG signals relating to the joints, flexors and extensors are recorded.

[0118] The signals recorded by the recording system 101 are stored in the memory of the recording system 101. These can be implemented by a control unit (not shown, but functioning as (as described above in relation to control unit 14).

[0119] PNS stimulation was performed on the proximal sciatic nerve 112 (above the branching point where it divides into separate bundles) (right side of Figure 3 ). The neuronal polyimide multichannel implant is inserted into the neural tissue (see bottom). can be obtained.

[0120] In this setup, the wires from the EMG electrodes and the epidural spinal electrodes were all connected to the rat's The EMG is routed subcutaneously to a common connector that is attached to the skull with dental cement. A signal amplifier and stimulator feeding the spinal cord can be plugged into this connector. Wires from the intraneural electrodes are routed subcutaneously to a plug in the rat's lumbar region to deliver stimulation. The device can be plugged into this plug.

[0121] As shown in the upper left part of Figure 3, the kinematics of the (bone crest, hip, knee, ankle and foot); The EMG activity of each (ankle, flexor and extensor muscles) is measured by sensors in the system 10'. It is recorded.

[0122] FIG. 4 illustrates how a system 10' such as that presented in FIG. 3 can be used in real time to We show how it is possible to generate efficient and improved motions.

[0123] Epidural electrodes, i.e., two monopolar wire electrodes 108, 110 (FIG. 3) on the lumbosacral spinal cord 102 The CNS stimulation module (see the upper right part of Fig. 18') electrically stimulates the locomotor network. This stimulates the brain to produce a functional walking pattern.

[0124] The generated movements of the rat 100 on the treadmill 114 are captured by, among other things, a camera 116. The rats were then identified using reflective markers glued to the hind limb joints (bony crest, hip, knee, ankle, and toe). is monitored in real time.

[0125] In this example, a control unit 14' (among other things, a controller that controls the components of the system 10') The generated walking pattern can be controlled by a line in real time. Compared to the cycle, the main events such as foot contact, toe off or maximum foot height and their associated The timing of these events is recognized in real time.

[0126] Also in this example, if the generated gait does not match the desired model walking cycle, Modify the generated gait using selective PNS at defined stages in the gait cycle. Good.

[0127] Bilateral intraneural electrodes in the right and left sciatic nerves were found in the pattern A transient electrical stimulus is delivered to correct the inaccuracies and improve gait.

[0128] In this example, the intensity of the PNS was controlled by the frequency of the delivered pulses.

[0129] FIG. 5 (top) shows a preliminary stage obtained using the system described in FIGS. The results of the study are presented below. Ankle flexion was induced by selective sciatic nerve stimulation of the peroneal nerve bundle at the beginning of the swing phase. whereas ankle extension was improved through a different activation site at the end of the stance phase. This was improved through selective stimulation of the tibial branch of the sciatic nerve.

[0130] Adding the PNS to the CNS has a profound effect on the stimulated and contralateral legs. Indeed, a large increase in step height was obtained for the leg additionally stimulated by the PNS. It was made.

[0131] Furthermore, the additional stimulation of the PNS significantly improved footholds compared with the CNS alone. was reduced.

[0132] Applying peripheral nervous system (PNS) stimulation via a PNS stimulation module 20 in one leg had a large effect on the other leg, e.g., greatly increasing the stride length of that leg.

[0133] This improvement in gait allows the Rat 100 to walk on the ground with significantly fewer missteps and falls. Able to walk (bottom of Fig. 5) and climb stairs (see the middle part of Fig. 5 with the stairs ST) It became.

[0134] The present invention has great potential to restore fine motor skills to people affected by paralysis. .

[0135] In particular, in the case of upper limb paralysis, spinal cord stimulation can selectively activate muscles in the forearm or fingers. In terms of what can be done, we have found that success has been quite limited.

[0136] Therefore, activating the reaching and grasping synergies centrally and improving them peripherally is , has great potential to restore functional, improved and controllable movement of the upper limb following paralysis.

[0137] Central neuromodulation in the form of spinal electrical stimulation generates motor synergies and results in functional Although these movements are spatially limited, the central nervous system is also involved in the regulation of the nervous system. By stimulating the peripheral nerves with additional stimulation frequencies, i) gradually improving the generated movements; ii) locally expanding the reachable space in a highly controllable manner This makes it possible.

[0138] Figure 6 illustrates this concept in a paraplegic framework.

[0139] The foot trajectories T1 and T1' (black) were obtained by central neuromodulation (electrical epidural stimulation of the lumbosacral spinal cord). The patient presented with moderate step height and foot trapping. By adjusting the step height of the stimulated leg, the gait cycle can be further adjusted gradually. or increase it by using higher frequencies (trajectory T2 at 30 Hz, trajectory T3 at 70 Hz) , or reduce the contralateral foot entrapment (trajectory T2' at 30 Hz and trajectory T2' at 70 Hz). It is possible to improve movement through the trajectory T3'. Peripheral nerve stimulation improves the overall stepping pattern of both the stimulated and contralateral legs This, in combination with central neuromodulation, improves the recovery of controlled movements. It will be improved.

[0140] The lower part of FIG. 6 shows the improved ipsilateral flexion and the foot trajectory for FES stimulation alone. The trajectory T1 is shown, and superimposed on it is the trajectory T3, which is the addition of PNS to the EES stimulation. can be.

[0141] PNS stimulation is performed in the range of 30 Hz (trajectory T2) to 70 Hz (trajectory T3).

[0142] The upper part of FIG. 6 shows the foot trajectory for improved contralateral extension with EES stimulation alone. Shown as trajectory T1' and superimposed with it is trajectory T3', which shows the addition of PNS to EES stimulation. is also shown.

[0143] PNS stimulation is performed in the range of 30 Hz (trajectory T2') to 70 Hz (trajectory T3').

[0144] FIG. 7 illustrates a closed-loop implementation of the neuromodulation and / or neurostimulation system 10 according to the present invention. FIG. 10 is a flowchart illustrating an example of how the embodiment works.

[0145] In step S1, a patient (or, as shown in the example of a mammal in FIGS. 3 to 6, The physiological signals of the animal (e.g., rat) are acquired and recorded. This is done by the detection unit 12. It can be done.

[0146] In step S2, the resulting signal is provided to the control unit 14.

[0147] In step S3, an initial stimulation parameter set is provided by the control unit 14. can be.

[0148] In step S4, the control unit 14 controls the PNS stimulation module 20 and and / or a stimulation control signal provided to control the CNS stimulation module 18; and physiological signals related to the subject's intention to move that are decoded from the brain and / or nervous system of the A match is made.

[0149] In step S5, the control unit 14 controls the PNS stimulation module 20 and and / or a stimulation control signal provided to control the CNS stimulation module 18, and A kinematic trajectory alignment is performed.

[0150] In step S6, the control unit 14 controls the PNS stimulation module 20 and and / or a stimulation control signal provided to control the CNS stimulation module 18; The desired force is then applied to the surface on which the subject is located or touching. .

[0151] In step S7, the control unit 14 controls the PNS stimulation module 20 and and / or a stimulation control signal provided to control the CNS stimulation module 18; Coordination of gait patterns and / or grip types and / or muscle activation for movement It will be held.

[0152] Steps S4 to S7 can be performed consecutively or in parallel.

[0153] In step S8, the physiological signal is decoded. This is done by the control unit 14. The control unit 14 controls the motion of the subject provided by the sensing unit 12. In particular, the motion of the subject and / or the motion of the subject can be detected so as to be able to decode signals related to the motion of the subject. The system continuously collects signals related to force and / or EMG activity and / or kinematic trajectories. The digital signal is configured so that it can be decoded by the digital signal.

[0154] As can be seen from the flow chart, the system 10 is a closed loop system. It functions in real time as

[0155] Step S8 is followed by step S1.

[0156] The exemplary control and estimation routines contained herein are directed to a variety of neuromodulatory and / or It should be noted that the present invention may be used in conjunction with any of the neurostimulation system configurations disclosed herein. The control methods and routines to be implemented may be stored as executable instructions in non-transitory memory. can be combined with a variety of sensors, actuators and other system hardware to control Certain routines described herein may be executed by an event control unit. Any number of processing strategies, such as interrupt-driven, interrupt-driven, multitasking, multithreading, etc. It can represent one or more of the various actions, movements and The steps and / or functions may be performed in the order shown, in parallel, or omitted in some instances. Similarly, the order of operations may not necessarily correspond to the order of operations of the exemplary embodiments described herein. It is not required to achieve the features and advantages, but is provided for ease of illustration and explanation. One or more of the illustrated actions, operations and / or functions are provided for the purpose of may be performed iteratively depending on the particular strategy being used. The actions, operations and / or functions described may be implemented by a computer readable processor in a control unit. The code programmed into the non-transitory memory of the storage medium may be represented diagrammatically. , where the actions described are performed by controlling various hardware components in an electronic control unit. The method is performed by executing instructions in a system including the program in combination with the program. [Explanation of symbols]

[0157] 10 Neuromodulation and / or Neurostimulation Systems 12 Detection unit 12a Detection unit 12b Detection unit 12c Sensor 12d Sensor 14 Control unit 16 Stimulation Units 18 Central Nervous System (CNS) Stimulation Module 20 Peripheral Nervous System (PNS) Stimulation Module 22 Implantable Pulse Generators (IPGs) 24 Implantable Pulse Generators (IPGs) 25 electrodes 26 electrodes 10' System 14' Control Unit 18' Central Nervous System (CNS) Stimulation Module 20' Peripheral Nervous System (PNS) Stimulation Module 100 rats 102 Spinal cord (rat) 104 Ankle Muscles 106 Bipolar Wire Electrode 107 Polyimide-based multi-channel neural implant 108 Unipolar Wire Electrode 110 Unipolar Wire Electrode 112 Sciatic Nerve 114 Treadmill 116 Cameras P patient K1 kinematic bone ridge signal K2 kinematic hip signal K3 kinematic knee signal K4 Kinematic ankle signal K5 kinematic foot signal M Memory ST stairs S1 Method step S1 S2 Method step S2 S3 Method step S3 S4 Method step S4 S5 Method step S5 S6 Method step S6 S7 Method Step S7 S8 Method step S8 T1 orbit (EES only) T2 orbit T3 orbit T1' orbit (EES only) T2' trajectory (EES and PNS with Hz) T3' orbit

Claims

1. A neuromodulation and / or neurostimulation system (10) comprising at least the following components: Basic, at least one detection unit (12), at least a control unit (14), at least one stimulation unit (16), at least one central nervous system (CNS) stimulation module (18); at least one peripheral nervous system (PNS) stimulation module (20); In particular, the components of the neuromodulation and / or neurostimulation system (10) At least one of the neuromodulation and / or neurostimulation systems is implantable. Tem (10).

2. The central nervous system (CNS) stimulation module (18) is capable of delivering epidural stimulation. and / or a subdural stimulation module capable of delivering subdural stimulation. a sensor module, and / or an intracortical stimulation module capable of providing intracortical stimulation; and / or an intrathecal stimulation module capable of providing intrathecal stimulation or The system (10) of claim 1, comprising:

3. The peripheral nervous system (PNS) stimulation module (20) provides electrical stimulation of peripheral nerves.

10. The functional electrical stimulation (FES) module according to claim 1, 2. The system (10) according to claim 2.

4. The central nervous system (CNS) stimulation module (18) is at least partially implantable. and / or the peripheral nervous system (PN S) The stimulation module (20) is at least partially implantable or at least The method according to any one of claims 1 to 3, characterized in that both the System (10).

5. The components of the neuromodulation and / or neurostimulation system (10) are in a closed loop system. The system (10) according to any one of claims 1 to 4, ）。

6. The components of the neuromodulation and / or neurostimulation system (10) are in an open loop system. The system (10) according to any one of claims 1 to 4, ）。

7. The control unit (14) is configured so that the control is performed in real time. A system (10) according to any one of claims 1 to 6.

8. The peripheral nervous system (PNS) stimulation module (20) is inserted into or on the surrounding structure. At least one electrode having at least one fixing element for fixing the electrode to the structure. A system (10) according to any one of claims 1 to 7, characterized in that it comprises an electrode. 。

9. The control unit (14) receives the signal provided by the sensing unit (12). Stimulation provided by the PNS stimulation module (20) based on the sensed signal; and / or the stimulation provided by the CNS stimulation module (18) by said control unit (14), said PNS stimulation module (20) and / or or a stimulation control signal provided to control the CNS stimulation module (18): Physiology related to the subject's intention to move as decoded from the subject's brain and / or nervous system. and / or by said control unit (14), said PNS stimulation module (20) and / or or the stimulation control signal provided to control the CNS stimulation module (18). to at least partially align with a desired kinematic trajectory, and / or by said control unit (14), said PNS stimulation module (20) and / or or the stimulation control signal provided to control the CNS stimulation module (18). a desired force on the surface on which the subject is standing or touching and / or at least partially consistent with by said control unit (14), said PNS stimulation module (20) and / or or the stimulation control signal provided to control the CNS stimulation module (18). , muscle activation for a certain walking pattern and / or grip type and / or movement At least partially consistent with 2. The method according to claim 1, characterized in that it is adapted to be adjustable and / or adaptable. A system (10) according to any one of claims 1 to 8.

10. The control unit (14) is provided by the sensing unit (12) and In particular, the subject's movements and / or the like can be detected in order to be able to decode signals related to body movements. The force and / or EMG activity and / or kinematic trajectory related signals are continuously 10. The system according to claim 9, characterized in that it is configured to be able to decode the （１０）。

11. The control unit (14) is provided by the PNS stimulation module (20). The stimulation provided by the CNS stimulation module (18) is at least partially The method according to any one of claims 1 to 10, characterized in that the electrodes are arranged so as to alternate periodically. The system (10) described above.

12. The control unit (14) is provided by the PNS stimulation module (20). The stimulation provided by the CNS stimulation module (18) is at least partially The method according to any one of claims 1 to 11, characterized in that the two are arranged to overlap each other. The system (10) described above.

13. The control unit (14) controls the PNS stimulation module (20) or the CNS stimulation module (22). The stimulation provided by the stimulation module (18) is coordinated with other stimulations to improve motor output. to be used at least in part for compensation of the stimulus provided by the module. The system (1) according to any one of claims 1 to 12, characterized in that it is configured as follows: ０）。

14. The control unit (14) controls the PNS stimulation module (20) or the CNS stimulation module (22). The heating module (18) can be independently controlled and switched on and off. A system (10) according to any one of the preceding claims, characterized in that

15. In particular, a neuromodulation and / or neurostimulation system according to any one of claims 1 to 14. Using a stimulatory system (10), we have developed a central nervous system (CNS) (20) stimulation system (PNS) combined with peripheral nervous system (PNS) (21). CNS) (18) Those who provide neuromodulation and / or neurostimulation by providing stimulation Law.

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