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EP-4252653-B1 - A NEUROSTIMULATION SYSTEM FOR CENTRAL NERVOUS STIMULATION (CNS) AND PERIPHERAL NERVOUS STIMULATION (PNS)

EP4252653B1EP 4252653 B1EP4252653 B1EP 4252653B1EP-4252653-B1

Inventors

  • Wurth, Sophie
  • Courtine, Grègoire
  • MICERA, SILVESTRO

Dates

Publication Date
20260506
Application Date
20170328

Claims (20)

  1. 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), and - at least one Central Nervous System, CNS, stimulation module (18), wherein at least one of the components of the neuromodulation and/or neurostimulation system (10) is implantable, wherein the at least one CNS stimulation module (18) is part of the at least one stimulation unit (16), wherein the at least one CNS stimulation module (18) is or comprises an Epidural Stimulation module capable to provide epidural stimulation and/or a subdural stimulation module capable to provide subdural stimulation and/or an intracortical stimulation module capable to provide intracortical stimulation and/or an intraspinal stimulation module capable to provide intraspinal stimulation, and wherein the at least one control unit (14) is configured to provide stimulation control signals to control the at least one CNS stimulation module (18) based on sensing signals provided and gained by means of the at least one sensing unit (12), such that the stimulation provided by the at least one CNS stimulation module (18) can be adjusted and/or adapted based on physiological signals sensed by the at least one sensing unit (12) related to a move intention of a subject decoded from the brain and/or nervous system, optionally in combination with one or more of: - a desired kinematic trajectory, - desired forces with respect to a surface, on which the subject is located or that the subject is touching, and/or - muscle activation for certain gait patterns and/or grasp types and/or movements.
  2. The system (10) according to claim 1, wherein the system (10) further includes at least one Peripheral Nervous System, PNS, stimulation module (20), and wherein the at least one PNS stimulation module (20) is configured and adapted to deliver intra-neural stimulation targeting the upper limb nerves and/or the lower limb nerves of a patient.
  3. The system (10) according to claim 2, wherein the at least one control unit (14) is configured such that the stimulation provided by either the at least one PNS stimulation module (20) or the at least one CNS stimulation module (18) is at least partially used for correction of the stimulation provided by the other stimulation module to refine motor output.
  4. The system (10) according to one of the preceding claims, wherein the at least one CNS stimulation module (18) is at least partially implantable or at least partially implanted.
  5. The system (10) according to one of claims 2 to 4, wherein the PNS stimulation module (20) is at least partially implantable or at least partially implanted.
  6. The system (10) according to one of the preceding claims, wherein the components of the neuromodulation and/or neurostimulation system (10) form a closed-loop system.
  7. The system (10) according to claim 6, characterized in that : the at least one sensing unit (12) is configured and adapted to sense one or more physiological signals from a patient during stimulation and transmit the sensed one or more physiological signals to the at least one control unit (14), and the at least one control unit (14) is configured and adapted to control the at least one stimulation unit (16) to control the at least one CNS stimulation module (18) and/or the at least one PNS stimulation module (20) based on the received one or more physiological signals from the patient.
  8. The system (10) according to claim 7, wherein said one or more physiological signals include one or more physiological signals related to: - a gait cycle of the patient, and/or - locomotion, and/or - standing, and/or - walking, and/or - one or more cardiovascular signals, in particular blood pressure and/or blood pulse, and/or - tonus, and/or - nerve stimulation, in particular nervous vagus stimulation; and/or - signals directly and/or indirectly related to the immunological system of the patient, and/or - body temperature.
  9. The system (10) according to one of the preceding claims, wherein the at least one sensing unit (12) includes one or more implantable sensors (12a, 12b) and/or one or more non-implantable sensors (12c, 12d).
  10. The system (10) according to one of the preceding claims, wherein the components of the neuromodulation and/or neurostimulation system (10) form an open-loop system.
  11. The system (10) according to claim 10, wherein the at least one control unit (14) is configured and adapted to control the at least one stimulation unit (16) to deliver stimulation according to pre-programmed sequences of stimulation sets or patterns.
  12. The system (10) according to one of the preceding claims, wherein the at least one control unit (14) is configured such that control is done in real-time.
  13. The system (10) according to one of claims 2 to 12, wherein the at least one PNS stimulation module (20) comprises at least one intra-neural electrode and/or at least one epineural electrode.
  14. The system (10) according to one of claims 2 to 13, wherein the at least one PNS stimulation module (20) comprises at least one electrode having at least one fixation element for anchoring the electrode in or to surrounding structures.
  15. The system (10) according to one of claims 2 to 14, wherein the at least one control unit (14) is configured to provide stimulation control signals to control the at least one PNS stimulation module (20) based on sensing signals provided and gained by means of the at least one sensing unit (12), such that the stimulation provided by the at least one PNS stimulation module (20) can be adjusted and/or adapted based on physiological signals sensed by the at least one sensing unit (12) related to a move intention of a subject decoded from the brain and/or nervous system, optionally in combination with one or more of: - a desired kinematic trajectory, - desired forces with respect to a surface, on which the subject is located or that the subject is touching, and/or - muscle activation for certain gait patterns and/or grasp types and/or movements.
  16. The system (10) according to claim 15, wherein the at least one control unit (14) is configured such that signals provided by the at least one sensing unit (12) and related to movement of the subject can be decoded, especially signals related to continuous movement of the subject and/or signals related to force(s) and/or EMG activity and/or kinematic trajectories can be decoded.
  17. The system (10) according to one of claims 2 to 16, wherein the at least one control unit (14) is configured such that the stimulation provided by the at least one PNS stimulation module (20) and provided by the at least one CNS stimulation module (18) is at least partially interleaved.
  18. The system (10) according to one of claims 2 to 16, wherein the at least one control unit (14) is configured such that the stimulation provided by the at least one PNS stimulation module (20) and provided by the at least one CNS stimulation module (18) is at least partially superimposed.
  19. The system (10) according to one of the preceding claims, wherein the at least one control unit (14) is capable to independently control and switch on and off either the at least one PNS stimulation module (20) or the at least one CNS stimulation module (18).
  20. The system (10) according to one of the preceding claims, wherein the at least one CNS stimulation module (18) and/or the at least one PNS stimulation module (20) are configured and adapted to deliver stimulation according to one or more stimulation parameters, preferably wherein said stimulation parameters include at least one among stimulation frequency, stimulation amplitude, and/or pulse width, preferably wherein the at least one CNS stimulation module (18) and the PNS stimulation module (20) are configured and adapted to deliver stimulation with stimulation frequency between 30 Hz and 120 Hz, and/or stimulation amplitude between 20 µA and 1000 µA, and/or pulse width between 0.040 µsec and 1 msec.

Description

The present invention relates to an active closed-loop medical system, especially an active closed-loop medical system for neurostimulation, e.g. in the field of improving recovery after neurological disorders like spinal cord injury (SCI), for example after trauma. EP 2 868 343 A1 discloses a system to deliver adaptive electrical spinal cord stimulation to facilitate and restore locomotion after neuromotor impairment. Inter alia, a closed-loop system for real-time control of epidural electrical stimulation is disclosed, comprising means for applying to a subject neuromodulation with adjustable stimulation parameters, means being operatively connected with a real-time monitoring component comprising sensors continuously acquiring feedback signals from subject, signals providing features of motion of a subject, system being operatively connected with a signal processing device receiving feedback signals and operating real-time automatic control algorithms, signal processing device being operatively connected with means and providing means with new stimulation parameters, with minimum delay. This known system improves consistency of walking in a subject with a neuromotor impairment. A Real Time Automatic Control Algorithm is used, comprising a feedforward component employing a single input-single output model (SISO), or a multiple input-single output (MISO) model. Reference is also made to 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. WO 2002/034331 A2 discloses a non-closed loop implantable medical device system that includes an implantable medical device, along with a transceiver device that exchanges data with the patient, between the patient and the implantable medical device, and between a remote location and the implantable medical device. A communication device coupled to the transceiver device exchanges data with the transceiver device, the implantable medical device through the receiver device, and between the transceiver device and the remote location to enable bi-directional data transfer between the patient, the implantable medical device, the transceiver device, and the remote location. A converter unit converts transmission of the data from a first telemetry format to a second telemetry format, and a user interface enables information to be exchanged between the transceiver device and the patient, between the implantable medical device and the patient through the transceiver device, and between the patient and the remote location through the transceiver device. US 2002/0052539 A1 describes a partial closed loop, non-continuous and non-real-time emergency medical information communication system and corresponding methods. The system permits an emergency alert to be issued on the basis of information sensed or processed by an implantable medical device (IMD) implanted within a body of a patient. The IMD is capable of bidirectional communication with a communication module, a mobile telephone and/or a Personal Data Assistant (PDA) located outside the patient's body. The communication module, a mobile telephone or a PDA is capable of communicating an emergency alert generated by the IMD to a remote computer via a communication system. At the remote computer system it may be determined that emergency remedial action is required. If so, the action is executed remotely from the remote computer system in the IMD via the communication system. US 7,149,773 B2 relates to methods, devices and systems for automatically generating invoices when medical services are provided to a patient are described. Invoices are automatically generated by the system, for example, when monitoring of certain aspects of the performance of an implantable medical device (IMD) implanted within a body of a patient is initiated by the patient or remotely, or when the delivery of a therapy to the patient through the IMD is initiated locally or remotely. The IMD is capable of bi-directional communication with a communication module, a mobile telephone and/or a Personal Data Assistant (PDA) located outside the patient's body. The system invoicing system may comprise the IMD, the communication module and/or a mobile telephone and/or a PDA, means for generating an invoice, a remote computer system, and a communication system capable of bi-directional communication, where the communication module, the mobile telephone and/or the PDA is capable of receiving information from the IMD or relaying information thereto. US 6,878,112 B2 discloses a plurality of co-operative and complementary software programs that are implemented in a web-enabled high speed computer system to remotely monitor, manage and modify the operational and functional parameters of a plurality of implanted medical devices (IMDs). The system utilizes virtual electrophysiologist module (VEM), chronic monitoring module (CMM) a