Implantable Spinal Cord Stimulation System for Spinal Cord Injury Rehabilitation Therapy

Abstract

The present invention discloses a spinal cord stimulation system, including an input device, a control device, and a stimulation device. The input device is configured to acquire user data related to the movement intention of a user and send the user data to the control device. The control device can determine the movement intention of the user according to the user data, and then trigger a stimulation strategy corresponding to the movement intention of the user, and send the corresponding stimulation strategy data to the stimulation device. The stimulation device can generate a specific stimulation signal sequence according to the stimulation strategy data and output it to one or more target positions. The present invention can promote the user to complete rehabilitation movements through stimulation output and assist in rehabilitation training, which is very valuable for the rehabilitation treatment of spinal cord injuries.

Description

Technical Field

[0001] The present invention belongs to the medical field, and particularly relates to an implantable spinal cord stimulation system for spinal cord injury rehabilitation treatment. Background Art

[0002] The World Health Organization estimates that 250,000 to 500,000 people worldwide suffer from some form of spinal cord injury each year, and severe spinal cord injuries lead to paralysis. Some people are born with a distorted spine, but for spinal deformities, in more cases, diseases, poor postures, external injuries, and malnutrition are the causes. The characteristics of spinal diseases are that they require long-term rehabilitation treatment and are prone to frequent relapses under incentives such as jolts, vibrations, and improper exertion. After the patient relapses, the pain is unbearable, and they are unable to take care of themselves. In severe cases, they are bedridden, bringing great pain to their own and their families' lives and spirits, and seeking medical treatment everywhere also brings a heavy economic burden to the family. The most common treatment method for spinal diseases is for the patient to lie flat on a hard bed board for natural recovery, plus massage assistance. The drawback of this treatment method is that the treatment time is relatively long, and due to the poor reduction of the spine, it is easy to relapse after treatment. Summary of the Invention

[0003] (1) Object of the Invention

[0004] The object of the present invention is to provide an implantable spinal cord stimulation system for spinal cord injury rehabilitation treatment, which can be used to assist in the rehabilitation treatment of spinal cord injury patients.

[0005] (2) Technical Solution

[0006] To solve the above problems, a first aspect of the present invention provides a spinal cord stimulation system, including an input device, a control device, and a stimulation device, wherein:

[0007] The input device is used to acquire user data related to the movement intention of the user and send the user data to the control device;

[0008] The control device can determine the movement intention of the user according to the user data, and then trigger a stimulation strategy corresponding to the movement intention of the user, and send the corresponding stimulation strategy data to the stimulation device;

[0009] The stimulation device can generate a specific stimulation signal sequence according to the stimulation strategy data and output it to one or more target positions.

[0010] Preferably, the input device includes a bioelectrical signal detection device, which can detect bioelectrical signals related to the movement intention of the user.

[0011] Preferably, the bioelectrical signals include the electroencephalogram signals and / or electromyogram signals of the user.

[0012] Preferably, the control device can define the stimulation strategy data of the movement intention based on a program group; the program group includes at least a part of the stimulation parameters corresponding to the user defined according to the movement intention; the control device includes a first storage unit for storing the stimulation strategy data;

[0013] The stimulation device can generate a specific stimulation signal sequence in response to the stimulation parameters of the program group.

[0014] Preferably, the stimulation strategy data includes the identification information of each program group corresponding to the triggered stimulation strategy, and the corresponding duration of each program group;

[0015] The stimulation device includes a second storage unit for storing the data of the stimulation parameters included in each program group.

[0016] Preferably, the stimulation strategy data includes the identification information of the triggered stimulation strategy;

[0017] The stimulation device includes a second storage unit for storing the identification data of the program groups corresponding to each stimulation strategy, the duration, and the data of the stimulation parameters of the program groups corresponding to each stimulation strategy.

[0018] Preferably, the stimulation parameters include the contact parameters, amplitude parameters, pulse width parameters, and / or frequency parameters of the stimulation sequence of at least one stimulation signal channel.

[0019] A second aspect of the present invention provides a spinal cord stimulation control device for a spinal cord stimulation system, including a first communication unit, a data processing unit, and a second communication unit;

[0020] The first communication unit can communicate with the input device of the spinal cord stimulation system to obtain user data related to the movement intention of the user;

[0021] The data processing unit can analyze the user data, determine the movement intention of the user, and then trigger a stimulation strategy corresponding to the movement intention of the user;

[0022] The second communication unit can communicate with the stimulation device of the spinal cord stimulation system to send the stimulation strategy data corresponding to the triggered stimulation strategy.

[0023] Preferably, the first communication unit is in a wired or wireless manner; the second communication unit is in a wireless manner.

[0024] Preferably, the data processing unit is configured to perform the following steps:

[0025] Step S1: Receive user data related to the user's exercise intention;

[0026] Step S2: Analyze the user data;

[0027] Step S3: Determine whether an exercise intention is recognized in the user data. If so, go to Step S4; otherwise, go to Step S1;

[0028] Step S4: Determine the stimulation strategy to be triggered according to the exercise intention, as well as the program group and stimulation time corresponding to the stimulation strategy. Send the data of the stimulation parameters of the first program group to the stimulation device and set its stimulation time, then go to Step S5;

[0029] Step S5: Determine whether the program group has been sent completely. If so, go to Step S2; otherwise, go to Step S6;

[0030] Step S6: Send the data of the stimulation parameters of the next program group and set its stimulation time, then go to Step S5.

[0031] (3) Beneficial effects

[0032] The above technical solution of the present invention has the following beneficial technical effects:

[0033] According to the EEG signal, different positions of the spinal cord are stimulated for injury rehabilitation through electrodes, generating corresponding muscle movements to assist in completing movements such as walking, thereby realizing the function of assisting the overall rehabilitation training. It can also complete rehabilitation actions by real-time controlling the stimulation output through the external programming software to assist in rehabilitation training, which is very valuable for spinal cord injury rehabilitation treatment. Description of the drawings

[0034] Figure 1 is a schematic structural diagram of a spinal cord injury rehabilitation treatment device according to an embodiment of the present invention;

[0035] Figure 2 is a schematic diagram of the stimulation strategy of a spinal cord injury rehabilitation treatment device according to an embodiment of the present invention;

[0036] Figure 3 is a block diagram of the structure of a spinal cord injury rehabilitation treatment device according to an embodiment of the present invention.

[0037] Figure 4 is a flowchart of the control method of a spinal cord injury rehabilitation treatment device according to an embodiment of the present invention.

[0038] Reference numerals:

[0039] 1: Input device; 2: Control device; 3: Stimulation device; 31: Communication module; 32: Pulse generator; 4: Electrode; 5: Program group G1; 6: Program group G2; 7: Program group G3; 8: Program group G4. Detailed implementation manners

[0040] To make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present invention will be further described in detail below in conjunction with the detailed implementation manners and with reference to the accompanying drawings. It should be understood that these descriptions are merely exemplary and are not intended to limit the scope of the present invention. In addition, in the following description, the descriptions of well-known structures and technologies are omitted to avoid unnecessarily confusing the concepts of the present invention.

[0041] The schematic diagram of the layer structure according to an embodiment of the present invention is shown in the accompanying drawings. These drawings are not drawn to scale, and for the purpose of clarity, some details are enlarged and some details may be omitted. The shapes of various regions and layers shown in the drawings, as well as their relative sizes and positional relationships, are merely exemplary. In practice, there may be deviations due to manufacturing tolerances or technical limitations, and those skilled in the art can design regions / layers with different shapes, sizes and relative positions according to actual needs.

[0042] Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the scope of protection of the present invention.

[0043] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0044] The present invention will be described in more detail below with reference to the accompanying drawings. In each of the drawings, the same elements are denoted by similar reference numerals. For the sake of clarity, the various parts in the drawings are not drawn to scale.

[0045] EEG is the abbreviation of electroencephalogram, which is the brain wave.

[0046] Figure 1 It is the schematic diagram of the structure of a spinal cord injury rehabilitation treatment device according to an embodiment of the present invention.

[0047] As Figure 1 shown, in an embodiment of the present invention, a spinal cord injury rehabilitation treatment device is provided, which is characterized by comprising:

[0048] An input device 1, which is used to obtain user data related to the movement intention of the user and send the user data to the control device 2.

[0049] A control device 2, which can determine the user's movement intention according to the user data, and then trigger a stimulation strategy corresponding to the user's movement intention, and send the corresponding stimulation strategy data to the stimulation device 3.

[0050] A stimulation device 3, which can generate a specific stimulation signal sequence according to the stimulation strategy data and output it to one or more target positions.

[0051] An electrode 4, which is used to output the stimulation signal to one or more target positions.

[0052] In a preferred embodiment, the input device 1 includes a device for detecting EEG. Thus, the device can perform injury rehabilitation stimulation on different positions of the spinal cord according to the EEG signal through the electrode, generate corresponding muscle movements, assist in completing movements such as walking, and thus play a role in assisting the overall rehabilitation training function. It can also complete rehabilitation actions by controlling the stimulation output in real time through an external programming software to assist in rehabilitation training, which is very valuable for spinal cord injury rehabilitation treatment.

[0053] Optionally, the electrode 4 is any electrode suitable for implantable spinal cord stimulation in the prior art.

[0054] Figure 2 It is a schematic diagram of the stimulation strategy of a spinal cord injury rehabilitation treatment device according to an embodiment of the present invention.

[0055] As Figure 2 shown, in another embodiment of the present invention, the stimulation device 3 further includes: a communication module 31, and the signal processing module 31 is used to trigger the spinal cord stimulation strategy with the movement intention.

[0056] The input device 1 may include an EEG detection unit for the scalp, and the EEG detection unit is used to obtain the EEG signal of the motor cortex.

[0057] The input device 1 may further include a sensor detection unit. The sensor detection unit may be sound detection, video detection, etc. The control device 2 identifies the movement intention according to the corresponding sensor input signal and quickly triggers the movement stimulation strategy in real time.

[0058] In a normal operation process (such as walking), the brain generates a movement intention, and the signal is transmitted to the corresponding muscle through the spinal cord to generate an action to complete walking. However, for patients with spinal cord injury, the brain movement intention signal cannot be transmitted to the muscle. Therefore, the role of this spinal cord injury rehabilitation treatment device is to convert the signal transmitted by the spinal cord into an electrical signal to play the role of transmitting the movement intention. The transmission process is carried out in real time, and the delay should be as short as possible. For example, when the patient wants to step on the right leg, the spinal cord injury rehabilitation treatment device should quickly stimulate the nerve to achieve this action. Experiments have proved that this will have a more obvious effect on spinal cord injury rehabilitation.

[0059] The detection method of the input device 1 can also be to obtain what the patient says or to detect through video, and then quickly start the stimulation according to the movement intention to achieve quasi-real-time actions.

[0060] Optionally, the stimulation device 3 further includes: a pulse generator 32, and the pulse generator 32 generates a stimulation signal according to the spinal cord stimulation strategy.

[0061] Optionally, the input device 1 transmits the electrical signal to the control device 2 through a wireless communication method or a wired communication method.

[0062] Optionally, the control device 2 transmits the electrical signal to the stimulation device 3 through a wireless communication method or a wired communication method.

[0063] Preferably, the input device 1 transmits the electrical signal to the control device 2 through a wireless communication method; the control device 2 transmits the electrical signal to the stimulation device 3 through a wireless communication method.

[0064] In a preferred embodiment, the input device 1 includes parts such as electroencephalogram acquisition electrodes, an amplification and sampling circuit module, and a data communication module. The data communication can be in a wired or wireless manner. The wireless communication method with the control device 2 can be Bluetooth or wifi, and the electroencephalogram acquisition channels can be 1-64 channels. The input device 1 can also be an implantable device that collects subcortical electroencephalogram and wirelessly transmits the electroencephalogram signal through Bluetooth.

[0065] The control device 2 can be a desktop converter, a laptop computer, a tablet computer, etc. The signal receiver and the control software are installed in the control device 2. The main functions include data communication control, motion decoding algorithm, stimulation strategy control, etc. It can decode the motion intention in real time through the electroencephalogram signal, start the spinal cord stimulation strategy for realizing rehabilitation movement studied and set before, and send control instructions to the spinal cord stimulation pulse generator 32 implanted in the patient's body in real time. The pulse generator 32 outputs a stimulation signal according to the stimulation strategy.

[0066] The communication method between the pulse generator 32 and the control device 2 can use Bluetooth or radio frequency wireless communication in the MICS band.

[0067] In a preferred embodiment, multiple stimulation program groups (such as 1 - 16) can be set in the parameter register of the pulse generator 32, and parameters such as the stimulation contacts, stimulation amplitude, stimulation frequency, and stimulation pulse width of each program group can be different. The logic control circuit realizes all communication, power management, parameter selection, and pulse output control functions of the pulse generator 32. Thus, it can receive an external command signal through the communication circuit, select the required stimulation program group parameters, and output them through the stimulation pulse output circuit. The electrode 4 has two types: a flat electrode 4 and a columnar electrode 4, which are implanted into the required epidural space of the spinal cord through surgical operation or puncture, and can have 8, 16, 24, or 32 contacts to facilitate the selection of different stimulation positions.

[0068] Figure 3 It is a structural block diagram of a spinal cord injury rehabilitation treatment device according to an embodiment of the present invention.

[0069] As Figure 3 shown, the detection unit 1 acquires the electro - signal of the patient's motor cortex; the electro - signal is transmitted to the conversion unit 2 through wireless communication transmission, and the electro - signal is converted to obtain the movement intention; the movement intention is transmitted to the signal processing module 21, and the spinal cord stimulation strategy is triggered according to the movement intention; the stimulation strategy is sent to the in - vivo pulse generator 32, the pulse generator 32 generates a stimulation signal, and according to the stimulation signal, the electrode 4 stimulates the spinal cord. Corresponding muscle movements are generated to assist in completing movements such as walking, thereby realizing the function of assisting the overall rehabilitation training.

[0070] In a preferred embodiment, the stimulation strategy consists of 4 program groups, which respectively include the following parameters.

[0071] Program group G1: stimulation contact 1, stimulation pulse width 1, stimulation amplitude 1, stimulation frequency 1, stimulation time 1;

[0072] Program group G2: stimulation contact 2, stimulation pulse width 2, stimulation amplitude 2, stimulation frequency 2, stimulation time 2;

[0073] Program group G3: stimulation contact 3, stimulation pulse width 3, stimulation amplitude 3, stimulation frequency 3, stimulation time 3;

[0074] Program group G4: stimulation contact 4, stimulation pulse width 4, stimulation amplitude 4, stimulation frequency 4, stimulation time 4.

[0075] Stimulating specific positions in the spinal epidural with specific parameters can generate specific muscle movements. For example, the spinal nerves in the lumbar 1-5 segments mainly control leg muscle movements. A specific combination of stimulation positions (corresponding to specific contacts on the electrodes) and stimulation parameters can correspond to a specific action (such as flexion and extension of the hip joint, knee joint, etc.). The movement stimulation strategy refers to selecting different sets of pre-set programs and performing stimulation for different durations in sequence, so as to be able to achieve a series of actions and then complete the leg walking activity. According to the individual situation of each patient, study in advance to find the program sets and stimulation times required to complete the rehabilitation walking action, and set the required program sets in the pulse generator. The number of program sets is identified by n. For example, a stimulation strategy requires n = 4 program sets. Program set 1 (denoted as G1) stimulates contact 5+ / 2-, with a stimulation amplitude of 2 mA, a frequency of 40 Hz, and a pulse width of 200 μs. The other program sets are G2, G3, and G4 in this order. An example of the stimulation strategy is: G1 for 200 ms, G2 for 300 ms, G3 for 500 ms, and G4 for 100 ms.

[0076] Each time a movement intention signal is recognized, the stimulation strategy control is initiated, and this cycle continues. There are two implementation methods for the stimulation strategy control.

[0077] One method is that the in-vivo pulse generator 32 only stores the required stimulation program sets, and the control of the stimulation sequence and stimulation time for different program sets are all implemented by the external control software. In this way, only parameter information such as the stimulation sequence and stimulation time needs to be transmitted between the stimulation device and the control device, and the detailed parameters of each program set do not need to be transmitted, thus saving communication time and accelerating the response speed.

[0078] The other method is that the in-vivo pulse generator stores the complete stimulation strategy, including different program sets and their stimulation sequences and stimulation times, and the control device only sends a stimulation strategy trigger notification to the stimulation device. In this implementation method, the amount of communication data between the control device and the stimulation device is less, and a faster response speed can be obtained.

[0079] After each stimulation of the spinal cord with a program set, it is judged whether all the stimulation program sets for the nerve required to complete the movement defined by the stimulation strategy have been reached. If not, the next program set stimulation operation is performed; if so, the strategy is ended, and it waits again for the trigger of the movement intention.

[0080] Figure 4 It is a flowchart of the control method for a spinal cord injury rehabilitation treatment device according to an embodiment of the present invention.

[0081] As Figure 4As shown, this embodiment provides a control method for a spinal cord injury rehabilitation treatment device, including: obtaining user data related to the movement intention of the user; detecting based on the user data and analyzing whether there is a movement intention; generating corresponding stimulation signals according to the movement intention; and releasing current according to the stimulation signals.

[0082] Optionally, the control method for the spinal cord injury rehabilitation treatment device may further include: matching a spinal cord stimulation strategy according to the movement intention.

[0083] Optionally, the control method for the spinal cord injury rehabilitation treatment device may further include: sending according to the stimulation strategy to generate corresponding stimulation signals.

[0084] Optionally, the electrical signal is transmitted outside the body for conversion.

[0085] Optionally, the transmission method includes: a wireless communication method or a wired communication method.

[0086] Optionally, the current release is carried out using electrodes.

[0087] It should be understood that the above specific embodiments of the present invention are only used for exemplary illustration or explanation of the principles of the present invention, and do not constitute a limitation on the present invention. Therefore, any modifications, equivalent replacements, improvements, etc. made without departing from the spirit and scope of the present invention shall be included within the protection scope of the present invention. In addition, the appended claims of the present invention are intended to cover all changes and modification examples falling within the scope and boundaries of the appended claims, or equivalent forms of such scope and boundaries.

Claims

1. A spinal cord stimulation system, characterized in that, it includes an input device, a control device, and a stimulation device, wherein: the input device is used to obtain user data related to the movement intention of the user and send the user data to the control device; the control device can determine the movement intention of the user according to the user data, and then trigger a stimulation strategy corresponding to the movement intention of the user, and send the corresponding stimulation strategy data to the stimulation device; the stimulation device can generate a specific stimulation signal sequence according to the stimulation strategy data and output it to one or more target positions; the input device includes a bioelectric signal detection device, which can detect bioelectric signals related to the movement intention of the user, and the bioelectric signals include the electroencephalogram signals of the user; the control device can define the stimulation strategy data of the movement intention based on a program group; the program group includes at least a part of the stimulation parameters corresponding to the user defined according to the movement intention; the control device includes a first storage unit for storing the stimulation strategy data; the stimulation device can generate a specific stimulation signal sequence in response to the stimulation parameters of the program group; the stimulation parameters include at least the contact parameters, amplitude parameters, pulse width parameters, and / or frequency parameters of the stimulation sequence of one stimulation signal channel; the stimulation device includes an electrode, which is used to be implanted into the epidural space of the spinal cord, and the stimulation device stimulates a specific position in the epidural space of the spinal cord with specific parameters.

2. The spinal cord stimulation system according to claim 1, characterized in that, the stimulation strategy data includes the identification information of each program group corresponding to the triggered stimulation strategy, and the corresponding duration of each program group; the stimulation device includes a second storage unit for storing the data of the stimulation parameters included in each program group.

3. The spinal cord stimulation system according to claim 1, characterized in that, the stimulation strategy data includes the identification information of the triggered stimulation strategy; the stimulation device includes a second storage unit for storing the identification data of the program groups corresponding to each stimulation strategy, the duration, and the data of the program group stimulation parameters corresponding to each stimulation strategy.

4. A spinal cord stimulation control device, characterized in that, it is used for a spinal cord stimulation system and includes a first communication unit, a data processing unit, and a second communication unit; the first communication unit can communicate with the input device of the spinal cord stimulation system to obtain user data related to the movement intention of the user; the data processing unit can analyze the user data, determine the movement intention of the user, and then trigger a stimulation strategy corresponding to the movement intention of the user; the second communication unit can communicate with the stimulation device of the spinal cord stimulation system to send the stimulation strategy data corresponding to the triggered stimulation strategy; the input device includes a bioelectric signal detection device, which can detect bioelectric signals related to the movement intention of the user, and the bioelectric signals include the electroencephalogram signals of the user; The control device can define the stimulation strategy data of the movement intention based on the program group; the program group includes at least a part of the stimulation parameters corresponding to the user defined according to the movement intention; the control device includes a first storage unit for storing the stimulation strategy data; The stimulation device can generate a specific stimulation signal sequence in response to the stimulation parameters of the program group; The stimulation parameters include at least the contact parameters, amplitude parameters, pulse width parameters, and / or frequency parameters of the stimulation sequence of at least one stimulation signal channel; The stimulation device includes electrodes for implanting into the epidural space of the spinal cord, and the stimulation device stimulates a specific position in the epidural space of the spinal cord with specific parameters.

5. The spinal cord stimulation control device according to claim 4, wherein, The first communication unit is in a wired or wireless manner; the second communication unit is in a wireless manner.

6. The spinal cord stimulation control device according to claim 4 or 5, wherein, The data processing unit is configured to perform the following steps: Step S1, receive user data related to the movement intention of the user; Step S2, analyze the user data; Step S3, determine whether a movement intention is recognized in the user data. If so, go to step S4; otherwise, go to step S1; Step S4, determine the stimulation strategy to be triggered according to the movement intention, as well as the program group and stimulation time corresponding to the stimulation strategy, send the data of the stimulation parameters of the first program group to the stimulation device and set its stimulation time, and go to step S5; Step S5, determine whether the program group has been sent completely. If so, go to step S2; otherwise, go to step S6; Step S6, send the data of the stimulation parameters of the next program group and set its stimulation time, and go to step S5.

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