NEUROMODULATION AND/OR NEUROSTIMULATION SYSTEM

Abstract

A system for neuromodulation or neurostimulation comprising at least one sensing unit configured to provide a sensor signal correlating with a physiological value describing neurological function or dysfunction of a patient, at least one control unit, at least one stimulation unit, and at least one of at least one Central Nervous System stimulation module for providing Central Nervous System stimulation or at least one Peripheral Nervous System stimulation module for providing Peripheral Nervous System stimulation, wherein the control unit is configured to detect the neurological dysfunction based on the sensor signal and to trigger the neuromodulation or neurostimulation. The disclosure further relates to a method for providing neuromodulation or neurostimulation and the use of a neuromodulation system in the method for the treatment of a patient.

Claims

1. A system for neuromodulation or neurostimulation comprising: at least one sensing unit configured to provide a sensor signal correlating with a physiological value describing neurological function or dysfunction of a patient; at least one control unit; at least one stimulation unit; and at least one of at least one Central Nervous System stimulation module for providing Central Nervous System stimulation; or at least one Peripheral Nervous System stimulation module for providing Peripheral Nervous System stimulation; wherein the control unit is configured to detect the neurological dysfunction based on the sensor signal and to trigger the neuromodulation or neurostimulation.

2. The system of claim 1, wherein at least one of the components of the system is implantable.

3. The system of claim 1, wherein the at least one sensing unit comprises: at least one of an electrocardiogram, an electroencephalogram, or an electromyogram; a patch clamp; a voltage clamp; an extracellular single-unit recorder; or a recorder of local field potentials.

4. The system of claim 1, wherein the at least one sensing unit comprises at least one of a blood pressure sensor, a pulse oximeter, a heart-rate sensor, a breathing rate sensor, a body temperature sensor, a pressure sensor, a pH sensor, a barometer, an inertial measurement unit, an accelerometer, a gyroscope, a chemical concentration sensor (glucose, water, sodium, calcium), a hormone sensor, a metabolites sensor, a sweat sensor, a gastrointestinal movement sensor, a hydration sensor, an electrolyte sensor, an arterial stiffness sensor, a urine concentration sensor, a urine volume sensor, a bladder volume sensor, a conductivity sensor, a capacitance sensor, a strain gauge sensor, or a genital blood flow sensor.

5. The system of claim 1, wherein the at least one of the at least one sensing unit and the control unit is configured to optimize stimulation parameters for stabilization, or treatment, or both, of the neurological function of a patient.

6. The system of claim 1, wherein the at least one sensing unit comprises at least one trigger configured to be triggered by a patient and providing a signal describing dysfunction of an autonomic function of a patient.

7. The system of claim 6, wherein the at least one trigger is a manual trigger.

8. The system of claim 1, wherein the Central Nervous System stimulation module comprises at least one of: an epidural stimulation module capable to provide epidural stimulation; a trans-cutaneous stimulation module capable to provide trans-cutaneous stimulation; a subdural stimulation module capable to provide subdural stimulation; an intracortical stimulation module capable to provide intracortical stimulation; or an intraspinal stimulation module capable to provide intraspinal stimulation.

9. The system of claim 1, wherein the Peripheral Nervous System stimulation module is a Functional Electrical Stimulation module capable to provide electrical stimulation of peripheral nerves.

10. The system of claim 1, wherein the Central Nervous System stimulation module is at least partially implantable or at least partially implanted; or the Peripheral Nervous System stimulation module is at least partially implantable or at least partially implanted; or the Central Nervous System stimulation module is at least partially implantable or at least partially implanted, and the Peripheral Nervous System stimulation module is at least partially implantable or at least partially implanted.

11. The system of claim 1, wherein the system is a closed-loop system.

12. The system of claim 1, wherein the system is an open-loop system.

13. The system of claim 1, wherein the components of the system form partially an open-loop system and partially closed-loop system.

14. The system of claim 1, wherein the control unit is configured for real-time control.

15. The system of claim 1, wherein the control unit is configured such that the Peripheral Nervous System stimulation provided by the Peripheral Nervous System stimulation module and the Central Nervous System stimulation provided by the Central Nervous System stimulation module is at least partially interleaved.

16. The system of claim 1, wherein the control unit is configured such that the Peripheral Nervous System stimulation provided by the Peripheral Nervous System stimulation module and the Central Nervous System stimulation provided by the Central Nervous System stimulation module is at least partially superimposed.

17. The system of claim 1, wherein the control unit is capable to independently control and switch on and off either the Peripheral Nervous System stimulation module or the Central Nervous System stimulation module.

18. The system of claim 1, wherein the system is configured to be combined with at least one additional system of claim 1, wherein the control unit is configured to trigger that at least one of the Peripheral Nervous System stimulation provided by the Peripheral Nervous System stimulation module or the Central Nervous System stimulation provided by the Central Nervous System stimulation module of the system is at least partially used for correction of effects of stimulation provided by the at least one additional system of claim 1.

19. A method for providing at least one of neuromodulation or neurostimulation to treat a patient's neurological dysfunction by using a system, the system for neuromodulation or neurostimulation comprising: at least one sensing unit configured to provide a sensor signal correlating with a physiological value describing the neurological dysfunction; at least one control unit; at least one stimulation unit; and at least one of at least one Central Nervous System stimulation module for providing Central Nervous System stimulation; or at least one Peripheral Nervous System stimulation module for providing Peripheral Nervous System stimulation; wherein the control unit is configured to detect the neurological dysfunction on the sensor signal and to trigger at least one of neuromodulation for stabilization or treatment of the neurological function of the patient.

20. The method of claim 19, the patient's neurological dysfunction comprises an autonomic dysfunction, an after-spinal cord injury, a traumatic brain injury, cerebral palsy, stroke, Parkinson Disease, multiple sclerosis, autonomic failure, autonomic neuropathy, or cancer of the neurological tissue.

Description

FIGURES

[0057] FIG. 1 a schematic overview of an embodiment of a system for neuromodulation or neurostimulation according to the present disclosure, with which the method according to the present disclosure can be performed; and

[0058] FIG. 2 a schematic overview of a further embodiment of the system according to the present disclosure, with which the method according to the present disclosure can be performed.

BRIEF DESCRIPTIONS OF THE DRAWINGS

[0059] FIG. 1 shows a schematic overview of an embodiment of the system for neuromodulation or neurostimulation 10 according to the present disclosure, with which the method according to the present disclosure can be performed.

[0060] In this embodiment, a system for neuromodulation or neurostimulation 10 is shown. The system 10 comprises a sensing unit 12. In this embodiment, the sensing unit 12 comprises a blood pressure sensor. In this embodiment, the sensing unit 12 comprises a finger blood pressure monitoring system. However, any other type of blood pressure sensor could be generally possible.

[0061] In an alternative embodiment, the system 10 can comprise more than one sensing unit 12. The sensing unit 12 could additionally or alternatively comprise a pulse oximeter, a heart-rate sensor, a breathing rate sensor, a body temperature sensor, a pressure sensor (for instance for sensing bladder internal pressure), a pH sensor, a barometer, an inertial measurement unit, an accelerometer, a gyroscope, a chemical concentration sensor (glucose, water, sodium, calcium), a hormone sensor, a metabolites sensor, a sweat sensor, a gastrointestinal movement sensor, a hydration sensor, an electrolyte sensor, an arterial stiffness sensor, a urine concentration sensor, a urine volume sensor, a bladder volume sensor, a conductivity sensor, a capacitance sensor, a strain gauge sensor, or a genital blood flow sensor.

[0062] In this embodiment, the system 10 further comprises a control unit 14. The system 10 may further comprise a stimulation unit 16. The stimulation unit 16 may be an implantable pulse generator. It is generally possible that, alternatively or additionally, other components of the system 10 are implantable. The system 10 may further comprise a CNS stimulation module 18. The CNS stimulation module 18 may comprise an electrode array for providing CNS stimulation, EES, or both. In other words, the CNS stimulation module may comprise an epidural stimulation module capable to provide epidural stimulation, in some embodiments, epidural electrical stimulation.

[0063] Consistent with disclosed embodiments, the electrode array may comprise a plurality of electrodes. In some embodiments, the electrode array comprises 16 electrodes. However, the electrode array can generally comprise n electrodes, with n being any natural number >0.

[0064] The sensing unit 12 may be connected to the control unit 14. This connection is a direct connection. In some embodiments, this connection can be a bidirectional connection. In some embodiments, this connection can be a wireless connection. The sensing unit 12 may provide a sensor signal correlating with blood pressure of a patient equipped with the system 10. The sensing unit 12 may provide a sensor signal indicating systolic blood pressure of the patient equipped with the system 10.

[0065] In general, the sensing unit 12 can provide a sensor signal correlating with a physiological value, which describes neurological function or dysfunction of a patient. In some embodiments, the physiological value describes autonomic function or dysfunction of a patient.

[0066] The sensor signal may be provided to the control unit 14. The control unit 14 detects hypotension of the patient based on the sensor signal. The control unit 14 can trigger neurostimulation for stabilization of blood pressure of the patient.

[0067] The control unit 14 is connected to the stimulation unit 16. This connection is a direct connection. Further, this connection is also a bidirectional connection and a wireless connection.

[0068] In general, the control unit 14 can detect a dysfunction of neurological function, preferably autonomic function of the patient based on the sensor signal and to trigger neuromodulation for stabilization or treatment of the neurological function, preferably autonomic function of the patient.

[0069] The stimulation unit 16 is connected to the CNS stimulation module 18. This connection is a direct connection. Further, this connection is also a unidirectional connection and a cable-bound connection.

[0070] In an alternative embodiment, the system 10 can comprise more than one control unit 14. Similarly, the system 10 can comprise more than one stimulation unit 16. In some embodiments, the stimulation unit 16 could be a non-implantable pulse-generator.

[0071] In other alternative embodiments, the system 10 could additionally or alternatively comprise a PNS stimulation module 20. The PNS stimulation module 20 could be a Functional Electrical Stimulation (FES) module capable to provide electrical stimulation of peripheral nerves.

[0072] In other alternative embodiments, the connection between the sensing unit 12 and the control unit 14 could be an indirect connection. The connection could be a unidirectional connection. The connection could be a cable-bound connection.

[0073] In other alternative embodiments, the connection between the control unit 14 and the stimulation unit 16 could be an indirect connection. The connection could be a unidirectional connection. The connection could be a cable-bound connection.

[0074] In other alternative embodiments, the connection between the stimulation unit 16 and the CNS stimulation module 18 could be an indirect connection. The connection could be a unidirectional connection. The connection could be a cable-bound connection.

[0075] In an alternative embodiment, the components of the system 10 can form an open-loop system 10. In another alternative system 10, the components of the system 10 can form partially an open-loop system and partially a closed-loop system.

[0076] Not shown in FIG. 1 is that alternatively, or additionally, to the epidural stimulation module, the CNS stimulation module 18 could comprise a transcutaneous stimulation module capable to provide transcutaneous stimulation, a subdural stimulation module capable to provide subdural stimulation, an intracortical stimulation module capable to provide intracortical stimulation, or an intraspinal stimulation module capable to provide intraspinal stimulation.

[0077] Further not shown in FIG. 1 is that the sensing unit 12 could alternatively or additionally comprise an electrocardiogram (ECG). The sensing unit 12 could also alternatively or additionally comprise an electroencephalogram (EEG), an electromyogram (EMG), a patch clamp, a voltage clamp, an extracellular single-unit recorder, or a recorder of local field potentials.

[0078] Further not shown in FIG. 1 is that the sensing unit 12 could additionally or alternatively comprise at least one trigger, e.g. a manual trigger, to be triggered by the patient and providing a signal describing dysfunction of the autonomic function, e.g. blood pressure, of the patient.

[0079] Further not shown in FIG. 1 is that the sensing unit 12 or the control unit 14 can optimize stimulation parameters for stabilization or treatment of the neurological function of the patient. In some embodiments, the neurological function may be an autonomic function of the patient.

[0080] In general, the system 10 can be used in a method for the treatment of a patient suffering from neurological dysfunction, including autonomic dysfunction, after spinal cord injury, traumatic brain injury, cerebral palsy, stroke, Parkinson Disease, multiple sclerosis, autonomic failure, autonomic neuropathy, cancer of the neurological tissue, or any other disease impairing the nervous system of the patient.

[0081] FIG. 2 shows a schematic overview of a further embodiment of the system 110 according to the present disclosure, with which the method according to the present disclosure can be performed.

[0082] The system 110 comprises the structural and functional features of the system 10 disclosed in FIG. 1. The corresponding reference numbers in FIG. 2 for identical or similar elements or features correspond to the corresponding reference numbers of FIG. 1 and to reflect this, then these reference numbers are taken and increased by the value 100.

[0083] In addition to the CNS stimulation module 118 the system 110 further comprises a PNS stimulation module 120. The stimulation unit 116 is connected to the CNS stimulation module 118 and the PNS stimulation module 120. Both connections are direct connections. Further, both connections are unidirectional connections. However, alternatively, the connection between the stimulation unit 116 and the CNS stimulation module 118 or the stimulation unit 116 or the PNS stimulation module 120 could be an indirect or bidirectional connection.

[0084] The connection between the stimulation unit 116 and the CNS stimulation module 118 is a cable-bound connection. However, in an alternative embodiment, this connection could be a wireless connection.

[0085] The connection between the stimulation unit 116 and the PNS stimulation module 120 is a wireless connection. However, in an alternative embodiment, this connection could be a cable-bound connection.

[0086] The CNS stimulation module 118 and the PNS stimulation module 120 are indirectly connected (via the stimulation unit 116). Not shown in FIG. 2 is that the CNS stimulation module 118 and the PNS stimulation module 120 could be directly connected (wireless or cable-bound connection, unidirectional or bidirectional connection).

[0087] The CNS stimulation module 118 is an epidural stimulation module for providing EES. The CNS stimulation module 118 comprises an electrode array, which is implantable.

[0088] The PNS stimulation module 120 is a Functional Electrical Stimulation (FES) module capable to provide electrical stimulation to peripheral nerves. In an alternative embodiment, the PNS stimulation module 120 provide electrical stimulation to smooth muscles of blood vessels.

[0089] The FES module provides stimulation transcutaneously. The FES module comprises an electrode placed transcutaneously and providing electrical stimulation to the lower legs of a patient. Alternatively, the FES module could be implantable or have the electrodes implanted. In general, the FES module could comprise a plurality of electrodes. The CNS stimulation module 118 can be at least partially implantable or at least partially implanted. The PNS stimulation module 120 can be at least partially implantable or at least partially implanted.

[0090] In this embodiment, the control unit 114 controls the stimulation provided by the PNS stimulation module 120 and the CNS stimulation module 118 such that the stimulation provided by the two stimulation modules 118, 120 is interleaved. In other words, the control unit 114 is configured such that the PNS stimulation provided by the PNS stimulation module 120 and the CNS stimulation provided by the CNS stimulation module 118 are least partially interleaved. Alternatively, the control unit 114 can be configured such that the PNS stimulation provided by the PNS stimulation module 120 and the CNS stimulation provided by the CNS stimulation module 118 is at least partially superimposed. In general, the system 110 can be used for a method for providing neuromodulation or neurostimulation by providing CNS stimulation combined with PNS stimulation.

[0091] Not shown in FIG. 2 is that it is generally possible that the control unit 114 can independently control and switch on and off either the PNS stimulation module 120 or the CNS stimulation module 118. Further not shown in FIG. 2 is that the system 110 can be a first system 110 which is configured and arranged to be combined with at least one further system for providing neurostimulation to the patient, wherein the control unit 114 of the first system 110 is configured and arranged to trigger that the PNS stimulation provided by the PNS stimulation module 120, or the CNS stimulation provided by the CNS stimulation module 118 of the first system 110, is at least partially used for correction of effects of stimulation provided by the at least one further system.

[0092] The foregoing descriptions have been presented for purposes of illustration. They are not exhaustive and are not limited to precise forms or embodiments disclosed. Modifications and adaptations of the embodiments will be apparent from consideration of the specification and practice of the disclosed embodiments. For example, the described implementations include hardware, but systems and methods consistent with the present disclosure can be implemented with hardware and software. In addition, while certain components have been described as being coupled to one another, such components may be integrated with one another or distributed in any suitable fashion.

[0093] Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as nonexclusive. Further, the steps of the disclosed methods can be modified in any manner, including reordering steps or inserting or deleting steps.

[0094] It should be noted that, the relational terms herein such as “first” and “second” are used only to differentiate an entity or operation from another entity or operation, and do not require or imply any actual relationship or sequence between these entities or operations. Moreover, the words “comprising,” “having,” “containing,” and “including,” and other similar forms are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items or meant to be limited to only the listed item or items.

[0095] The features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended that the appended claims cover all systems and methods falling within the true spirit and scope of the disclosure. As used herein, the indefinite articles “a” and “an” mean “one or more.” Similarly, the use of a plural term does not necessarily denote a plurality unless it is unambiguous in the given context. Further, since numerous modifications and variations will readily occur from studying the present disclosure, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure.

[0096] As used herein, unless specifically stated otherwise, the terms “and/or” and “or” encompass all possible combinations, except where infeasible. For example, if it is stated that a database may include A or B, then, unless specifically stated otherwise or infeasible, the database may include A, or B, or A and B. As a second example, if it is stated that a database may include A, B, or C, then, unless specifically stated otherwise or infeasible, the database may include A, or B, or C, or A and B, or A and C, or B and C, or A and B and C.

[0097] It is appreciated that the above-described embodiments can be implemented by hardware, or software (program codes), or a combination of hardware and software. If implemented by software, it may be stored in the above-described computer-readable media. The software, when executed by the processor can perform the disclosed methods. The computing units and other functional units described in this disclosure can be implemented by hardware, or software, or a combination of hardware and software. One of ordinary skill in the art will also understand that multiple ones of the above-described modules/units may be combined as one module/unit, and each of the above-described modules/units may be further divided into a plurality of sub-modules/sub-units.

[0098] In the foregoing specification, embodiments have been described with reference to numerous specific details that can vary from implementation to implementation. Certain adaptations and modifications of the described embodiments can be made. Other embodiments can be apparent to those skilled in the art from consideration of the specification and practice of the disclosure disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims. It is also intended that the sequence of steps shown in figures are only for illustrative purposes and are not intended to be limited to any particular sequence of steps. As such, those skilled in the art can appreciate that these steps can be performed in a different order while implementing the same method.