Granted Patent B2

US 11,691,015 · App. 17/033,431 · Granted Jul 4, 2023

Inventors: Karen Minassian (Vienna, AT); Fabien Wagner (Lausanne, CH); Grégoire Courtine (Lausanne, CH)

Assignee: Onward Medical N.V.

A61N1/36146A61N1/36003A61N1/36062A61N1/36067A61N1/36157A61N1/36171A61N1/36175A61N1/0553

Abstract

Claims (49)

1. A system for neuromodulation or neurostimulation, for the treatment of a subject, comprising:

at least a stimulation controller;

at least a stimulation pattern storage drive which is connected to the stimulation controller and which comprises stimulation data, the stimulation pattern storage drive comprises:

at least one spatial stimulation pattern data storage module for the spatial component;

at least one temporal stimulation pattern data storage module for the temporal component; and

wherein the stimulation controller is capable of accessing the modules or reading out the modules independently from each other;

at least one electrical stimulation device; and

at least one electrical interface between the at least one electrical stimulation device and the subject, the at least one electrical interface being connectable with at least one bio-interface of or with a nervous system of the subject;

wherein the at least one electrical interface and the at least one bio-interface or the nervous system are arranged such that signals and/or data are exchanged from the electrical interface to the bio-interface or vice versa,

wherein the stimulation controller is capable to send configuration signals on a basis of the stimulation data to the at least one electrical stimulation device such that via the at least one electrical interface an electrical stimulation is provided to the bio-interface,

wherein the electrical stimulation provided is characterized by one or more stimulation parameters that vary over time in a pre-programmed manner;

wherein the stimulation data represent pre-programmed patterns which comprise at least a spatial component which is related to a part of the nervous system being stimulated and a temporal component which is related to a time at which the spatial component is applied; and

wherein the system is a combination of an open-loop stimulation and a closed-loop stimulation or may switch between the open-loop stimulation and the closed-loop stimulation.

2. The system of claim 1 , wherein the one or more stimulation parameters is at least one of stimulation frequency, stimulation amplitude, stimulation current, or pulse width.

3. The system of claim 1 , wherein the electrical stimulation device comprises a plurality of electrodes and wherein the spatial component comprises data related to activation and non-activation of defined subsets of the plurality of electrodes.

4. The system of claim 1 , wherein the stimulation data comprises meta data, which link the spatial component and the temporal component to each other.

5. The system of claim 1 , wherein the stimulation data comprises data representing a sequence of stimulation patterns adapted for bladder or sexual functions neurorehabilitation training, or for blood pressure control for counteracting orthostatic hypotension when the subject is verticalized or moves to a sitting position or a standing position or engages in sitting training or standing training.

6. The system of claim 5 , wherein the sequence of stimulation patterns comprises a plurality of ordered stages which are arranged to form in their order a replication of physiological activation signals, the physiological activation signals including spinal activation signals for bladder or sexual functions neurorehabilitation training, or for blood pressure control for counteracting orthostatic hypotension when the subject is verticalized or moves to a sitting position or a standing position or engages in sitting training or standing training.

7. The system of claim 1 , wherein the stimulation data comprises data representing a sequence of stimulation patterns exploiting a skeletal muscle pump for pumping blood from at least one extremity of the subject in a direction back to a heart of the subject, wherein the sequence comprises:

at least a first sequence related to stimulation of a muscle in the at least one extremity of the subject to contract the muscle; and

at least a second sequence related to stimulation of the muscle in the at least one extremity to relax the muscle.

8. The system of claim 1 , wherein the open-loop stimulation is configured such that the stimulation data is capable of being re-configured or adjusted based on feedback data sensed by the system, wherein the re-configuration or adjustment is done in real-time.

9. The system of claim 1 , wherein the stimulation data represents a sequence of stimulation patterns, wherein the sequence of stimulation patterns is a_-starting sequence.

10. The system of claim 1 further comprising:

at least one initialization module usable for open-loop stimulation; and

initialization data, the initialization data including stimulation data stored in the stimulation pattern storage drive;

wherein the at least one initialization module is configured and arranged to control the electrical stimulation device based on the initialization data such that the electrical stimulation device provides neuromodulation signals or neurostimulation signals for an initialization action or movement of the subject.

11. The system of claim 10 , wherein the open-loop is configured and arranged such that the initialization module and initialization data are used to start the closed-loop stimulation.

12. The system of claim 1 , wherein the open-loop system comprises:

at least one fallback module; and

fallback module data;

wherein the at least one fallback module is configured to control the electrical stimulation device based on the fallback module data when the closed-loop stimulation is out of service.

13. The system of claim 1 , wherein the stimulation data represents a sequence of stimulation patterns adapted to help restore a sweating function in a body part of the subject.

14. A method for neuromodulation or neurostimulation for the treatment of a subject, comprising:

providing at least one electrical stimulation device; and

providing at least one electrical interface between the at least one electrical stimulation device and the subject;

connecting at least one neural interface between the subject to the at least one electrical interface; and

applying electrical stimulation using the at least one electrical stimulation device through the at least one electrical interface;

wherein the subject is stimulated with the at least one electrical stimulation device using stimulation pattern data, the stimulation pattern data represents pre-programmed patterns comprising:

a spatial component related to a part of a nervous system of the subject being stimulated; and

a temporal component related to a time at which each spatial component is applied;

wherein the electrical stimulation provided is characterized by stimulation parameters that vary over time in a pre-programmed manner; and

wherein the electrical stimulation is a combination of open-loop stimulation and closed-loop stimulation or may switch between the open-loop stimulation and closed-loop stimulation;

wherein the electrical stimulation is provided in one or more sequences, cyclically, or repeatedly:

wherein the one or more sequences comprise a plurality of ordered stimulation patterns which are arranged in that they form in their order a replication of phvsiological activation signals of particular muscle groups at an appropriate time for a specific task or movement of the subject;

wherein the speeific task or movement is at least one of walking, standing up, sitting down, climbing staircases, cycling, lifting a foot, or placing or moving an extremity or a head of the subject.

15. The method of claim 6 , wherein the electrical stimulation stimulates at least one muscle of the subject for pumping blood from at least one extremity of the subject in a direction back to a heart of the subject.

16. The method of claim 15 , wherein under conditions where the electrical stimulation stimulates the at least one muscle of the subject, the at least one muscle is stimulated to contract and relax alternately.

17. The method of claim 14 , wherein the electrical stimulation stimulates at least one muscle of the subject to bring back a sweating function in a body part of the subject.

Assignments (6)

Priority Claims (1)

Continuity (2)

Cited By (10)

US 1,067,921 US 12,408,974 US 12,415,079 US 12,465,776 US 12,478,806 US 12,539,167 US 12,613,624 US 12,623,080 US 12,649,062 US 12,708,775