WO2023124617A1

WO2023124617A1 - Implantable stimulation system

Info

Publication number: WO2023124617A1
Application number: PCT/CN2022/132663
Authority: WO
Inventors: 陈晶华; 朱为然; 刘彬
Original assignee: 苏州景昱医疗器械有限公司
Priority date: 2021-12-30
Filing date: 2022-11-17
Publication date: 2023-07-06
Also published as: CN216629431U

Abstract

An implantable stimulation system (10), comprising: a nerve stimulator (100) provided in a patient's cranium; and an in-vitro program controller (200) provided on the patient in vitro and used for providing a program control signal for controlling the nerve stimulator (100) to perform electrical stimulation therapy to the nerve stimulator (100). The nerve stimulator (100) comprises a first group of stimulation contacts (131) to a fourth group of stimulation contacts (134), a first stimulation source (121) to a fourth stimulation source (124), and a controller (111). The controller (111) is electrically connected to each stimulation source, generates at least two stimulation control signals, and outputs each stimulation control signal to one or more stimulation sources. Each stimulation source is used for receiving a corresponding stimulation control signal, generating electrical stimulation and outputting same to a corresponding group of stimulation contacts. The implantable stimulation system (10) can perform various electrical stimulation on a plurality of brain tissues of the left and right brain of the patient.

Description

Implantable Stimulation System

This application claims the priority of the Chinese patent with application number 202123447537.7 filed on December 30, 2021, which is incorporated by reference in its entirety.

technical field

The present application relates to the technical field of implantable medical devices, for example, to an implantable stimulation system.

Background technique

In implantable medical devices, neurostimulators can effectively control the symptoms of functional diseases and mental diseases through chronic electrical stimulation to patients. Therefore, the treatment method of implanted stimulators can be applied to the treatment of various diseases.

The inventors have found that the simultaneous treatment of the left and right brains of the patient with a neurostimulator has a prominent effect on the recovery of the patient. Therefore, doctors need to perform electrical stimulation therapy on different brain tissues of the patient's left and right brains at the same time, but the relevant neurostimulators do not take this into account. When doctors need to perform electrical stimulation therapy on patients, they mainly implant multiple neurostimulators in the left and right brains of patients. In addition to suffering from pain, the patient also increases the patient's financial burden and implants multiple neurostimulators in the body. pain of.

Contents of the invention

The purpose of this application is to provide an implantable stimulation system, which does not need to implant multiple nerve stimulators in the patient's body, so that multiple brain tissues of the left and right brains of the patient can receive multiple electrical stimulations.

The purpose of this application adopts following technical scheme to realize:

The present application provides an implantable stimulation system, including: a nerve stimulator installed inside the patient's brain; an external program controller installed outside the patient's body; the external program controller is used to control the nerve stimulator for electrical stimulation therapy Program control signals to the neural stimulator, the neural stimulator includes: a first group of stimulating contacts to a fourth group of stimulating contacts, the first group of stimulating contacts and the second group of stimulating contacts are arranged on the left brain, The third group of stimulation contacts and the fourth group of stimulation contacts are arranged on the right brain; the first stimulation source to the fourth stimulation source, each of the stimulation sources is connected to one group of the stimulation contacts in a one-to-one correspondence a controller, the controller is electrically connected to each of the stimulation sources, and the controller is used to receive the programming signal, generate at least two stimulation control signals and output each stimulation control signal to one or more each of the stimulation sources, and each of the stimulation sources only receives one of the stimulation control signals; each of the stimulation sources is used to receive the corresponding stimulation control signal, generate electrical stimulation and output it to a corresponding group As for the stimulation contacts, each group of the stimulation contacts is used to receive the electrical stimulation and release the energy corresponding to the electrical stimulation at the brain tissue corresponding to the stimulation contacts.

The beneficial effect of this technical solution is that: without the need to implant multiple stimulators, electrical stimulation therapy can be performed on the left and right brains of patients at the same time; in addition, the electrical stimulation energy released by the stimulation contacts can be controlled by different stimulation signals. The controlled generation can release different electrical stimulation energies to different brain tissues for treatment. Thus, the above-mentioned embodiment implements a low-cost treatment plan for doctors to perform multiple electrical stimulations on multiple brain tissues of the left and right brains of patients, which greatly reduces the economic burden of patients and reduces the cost of implanting multiple stimulators in the patient's body. pain.

In a possible implementation manner, the controller is configured to generate a first stimulus control signal and output it to the first stimulus source and the third stimulus source, and generate a second stimulus control signal and output it to the second stimulus source and the third stimulus source. The fourth stimulus.

The beneficial effect of the technical solution is that: on the one hand, both the left brain tissue and the right brain tissue can be electrically stimulated with two different energies; on the other hand, the first stimulation control signal and the second stimulation control signal are respectively output to the functional A source of stimulation for the left and right hemispheres. As a result, patients receive more balanced electrical stimulation therapy on the left and right brains.

In a possible implementation manner, the controller is configured to generate a first stimulation control signal and output it to the first stimulation source, generate a second stimulation control signal and output it to the second stimulation source, and generate a third stimulation control signal and output to the third stimulus source, and generate a fourth stimulus control signal and output to the fourth stimulus source.

The beneficial effect of this technical solution is that the doctor can perform electrical stimulation on multiple brain tissues of the left and right brains of the patient, so as to meet the doctor's demand for diagnosis and treatment of some patients. Therefore, the above setting can meet the needs of doctors to perform various electrical stimulation treatments on multiple brain tissues of the patient's left and right brains.

In a possible implementation manner, the controller is configured to control each of the stimulation sources to cyclically generate electrical stimulation corresponding to multiple stimulation parameter combinations.

The beneficial effect of this technical solution is that: the controller controls each of the stimulation sources to generate electrical stimulation corresponding to a variety of stimulation parameter combinations, especially when the patient is out and there is no external program controller around, the electrical stimulation can also be performed. Adjusted, more user-friendly. Therefore, without the program control of the external program controller, the stimulus source can be used to cyclely generate electrical stimulation corresponding to the combination of stimulation parameters through the controller, which is beneficial for patients to receive treatment anytime and anywhere.

In a possible implementation manner, at least one of the electrical stimulation frequency parameter, pulse width parameter, amplitude parameter and time parameter corresponding to each stimulation parameter combination has a different value.

The beneficial effect of this technical solution is that by combining the frequency parameters, pulse width parameters, amplitude parameters and time parameters of electrical stimulation, a stimulation parameter combination suitable for the patient can be obtained, and the electrical stimulation can be performed according to the stimulation parameter combination treatment, reduce the pain of patients, and improve the effect of electrical stimulation therapy for patients.

In a possible implementation manner, the neural stimulator further includes a plurality of stimulation leads and a plurality of first switches for connecting the stimulation source and the stimulation contacts, each of the stimulation contacts passes through One stimulation lead is connected to a corresponding stimulation source, and one first switch is arranged between each stimulation lead and the stimulation source.

The beneficial effect of this technical solution is that: when the first switch between the stimulation source and a stimulation lead is turned on, the electrical stimulation generated by the stimulation source can be transmitted to the stimulation contact corresponding to the stimulation lead; When the first switch between them is turned off, the electrical stimulation generated by the stimulation source cannot be transmitted to the stimulation contacts corresponding to the stimulation leads. Since the stimulation contacts corresponding to other stimulation leads will not be affected, setting multiple stimulation leads and multiple first switches can accurately control the electrical stimulation of the brain tissue of the patient to be treated.

In a possible implementation manner, the number of the stimulation contacts in each group of the stimulation contacts is 4, 8 or 12.

The beneficial effect of this technical solution is that doctors can realize electrical stimulation therapy with multiple stimulation contacts without implanting multiple stimulators to patients, and increase the number of stimulation contacts to make the range of brain electrical stimulation more extensive. Wide, improve the effect of brain electrical stimulation therapy. Thus, the economic burden of the patient is greatly reduced, and the pain of implanting multiple stimulators in the patient's body is relieved.

In a possible implementation, the brain tissues corresponding to the first group of stimulation contacts to the fourth group of stimulation contacts are the left anterior limb of the internal capsule, the left nucleus accumbens, the right anterior limb of the internal capsule, and the right accumbens. nuclear.

When the brain tissues corresponding to the first group of stimulation contacts to the fourth group of stimulation contacts are respectively the left anterior limb of the internal capsule, the left nucleus accumbens, the right anterior limb of the internal capsule and the right nucleus accumbens,

The beneficial effect of the technical solution is that: when the electrical stimulation energy release area of the stimulation contact corresponds to the above-mentioned brain tissue, the treatment effect by electrical stimulation is good.

In a possible implementation manner, a two-way communication connection is performed between the external programmer and the neural stimulator through a MICS frequency band.

The beneficial effect of this technical solution is that when the external program controller and the neural stimulator are connected through two-way communication through the MICS frequency band, the attenuation degree of the communication signal propagating in the living body is small, thereby reducing the power consumption of the neural stimulator and improving the neurostimulator. The standby time of the stimulator.

In a possible implementation manner, the communication mode between the external program controller and the external program-controlled device is Bluetooth communication.

The beneficial effect of the technical solution is that the communication components corresponding to the bluetooth communication have small volume and low power consumption, and when the communication mode between the in vitro program controller and the external program control equipment is bluetooth communication, the energy consumption of the in vitro program controller and the external program control equipment can be reduced. power consumption.

In a possible implementation manner, the type of disease that the implantable stimulation system is used for treatment or management includes any one or more of the following: spasticity disease, pain, migraine, mental illness, bipolar disorder, anxiety disorder , post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder, behavioral disorder, mood disorder, memory disorder, mental status disorder, mobility disorder, Huntington's disease, Alzheimer's disease, drug addiction disorder, and other neurological or psychiatric disorders disease and damage. The beneficial effect of the technical solution is that the implantable stimulation system can be used for the treatment or management of various diseases, and has a wide range of applications.

Description of drawings

The application will be further described below in conjunction with the accompanying drawings and embodiments.

Fig. 1 is a schematic structural diagram of an implantable stimulation system provided by an embodiment of the present application;

Fig. 2 is a schematic structural diagram of another implantable stimulation system provided by the embodiment of the present application;

Fig. 3 is a schematic structural diagram of another implantable stimulation system provided by the embodiment of the present application;

Fig. 4 is a schematic structural diagram of another implantable stimulation system provided by the embodiment of the present application;

Fig. 5 is a partial structural schematic diagram of a nerve stimulator provided in an embodiment of the present application.

In the figure: 10, implantable stimulation system; 100, nerve stimulator; 200, external program controller; 111, controller; 121, first stimulation source; 122, second stimulation source; 123, third stimulation source; 124 , the fourth stimulus source; 130, slice electrodes; 131, the first group of stimulating contacts; 132, the second group of stimulating contacts; 133, the third group of stimulating contacts; 134, the fourth group of stimulating contacts; 141, Stimulation leads; 151. First switch.

Detailed ways

In order to enable those skilled in the art to better understand the solution of the present application, the technical solution in the embodiment of the application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiment of the application. Obviously, the described embodiment is only It is an embodiment of a part of the application, but not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without creative efforts shall fall within the scope of protection of this application.

In this application, "at least one" means one or more, and "multiple" means two or more. "And/or" describes the association relationship of associated objects, indicating that there may be three types of relationships, for example, A and/or B, which can mean: A exists alone, A and B exist at the same time, and B exists alone, where A, B can be singular or plural. The character "/" generally indicates that the contextual objects are an "or" relationship. "At least one of the following" or similar expressions refer to any combination of these items, including any combination of single or plural items. For example, at least one item (piece) of a, b or c can represent: a, b, c, a and b, a and c, b and c or a and b and c, wherein a, b and c can be It can be single or multiple. It should be noted that "at least one item (item)" can also be interpreted as "one item (item) or multiple items (item)".

In this application, words such as "exemplary" or "for example" are used to mean an example, illustration or description. Any embodiment or design described herein as "exemplary" or "for example" is not to be construed as preferred or advantageous over other embodiments or designs. Rather, the use of words such as "exemplary" or "such as" is intended to present related concepts in a concrete manner.

In the following, one of the application fields (namely, implantable neurostimulator) of the embodiment of the present application will be briefly described first.

An implantable neurostimulation system (an implanted medical system) mainly includes a stimulator implanted in a patient (ie, a neurostimulator) and a program-controlled device installed outside the patient's body. The related neuromodulation technology mainly uses stereotaxic surgery to implant electrodes in specific structures (i.e., targets) in the body, and the stimulator implanted in the patient sends electrical pulses to the targets through the electrodes to regulate the electrical activity of the corresponding neural structures and networks. Activities and their functions, thereby improving symptoms and relieving pain. Among them, the stimulator can be an implantable electrical nerve stimulation device, an implantable cardiac electrical stimulation system (also known as a cardiac pacemaker), an implantable drug infusion device (Implantable Drug Delivery System, referred to as IDDS) and a wire. Any one of the switching devices. Implantable electrical nerve stimulation devices are, for example, Deep Brain Stimulation (DBS), Implantable Cortical Nerve Stimulation (CNS), Implantable Spinal Cord Stimulation , referred to as SCS), implanted sacral nerve stimulation system (Sacral Nerve Stimulation, referred to as SNS), implanted vagus nerve stimulation system (Vagus Nerve Stimulation, referred to as VNS) and so on.

The stimulator can include IPG, extension wires and electrode wires. IPG (implantable pulse generator, implantable pulse generator) is set in the patient's body, receives program-controlled instructions sent by the program-controlled device, and relies on sealed batteries and circuits to provide controllable pulses to tissues in the body. The (electrical stimulation) energy, through the implanted extension lead and electrode lead, delivers one or two controllable specific electrical stimuli to specific areas of the tissue in the body. The extension wire is used in conjunction with the IPG as a transmission medium for the electrical stimulation signal, and transmits the electrical stimulation signal generated by the IPG to the electrode wire. Electrode leads deliver electrical stimulation to specific areas of tissue in the body through multiple electrode contacts (ie, stimulation contacts). The stimulator is provided with one or more electrode wires on one side or both sides, and a plurality of electrode contacts are arranged on the electrode wires, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wires. As an example, the electrode contacts may be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire. Electrode contacts may include stimulation electrode contacts and/or collection electrode contacts. The electrode contacts can be in the shape of, for example, a sheet, a ring, or a dot.

In some possible implementations, the stimulated body tissue may be the patient's brain tissue, and the stimulated site may be a specific part of the brain tissue. When the disease type of the patient is different, the stimulated site is generally different. The embodiment of the present application does not limit the applicable disease types, which may be the applicable disease types for deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among the types of disorders that DBS can be used to treat or manage include, but are not limited to: spasticity disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD), conduct disorder, mood disorder, memory disorder, mental status disorder, mobility disorder (eg, essential tremor or Parkinson's disease), Huntington's disease, Al Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric conditions and impairments.

In the embodiment of the present application, when the program-controlled device and the stimulator establish a program-controlled connection, the program-controlled device can be used to adjust the stimulation parameters of the stimulator (different stimulation parameters correspond to different electrical stimulation signals), and the stimulator can also be used to sense the deep brain of the patient. The bioelectric activity of the stimulator can be used to collect the electrophysiological signal, and the stimulation parameters of the electrical stimulation signal of the stimulator can be adjusted continuously through the collected electrophysiological signal.

Stimulation parameters can include: frequency (for example, the number of electrical stimulation pulse signals per unit time 1s, unit is Hz), pulse width (duration of each pulse, unit is μs), amplitude (generally expressed by voltage, that is, The intensity of each pulse, the unit is V), timing (for example, it can be continuous or triggered), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cycle stimulation mode), doctor's control upper limit One or more of upper and lower limits (range adjustable by doctors) and upper and lower limits of patient control (range adjustable by patients).

In a specific application scenario, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

The program-controlled device outside the body (that is, the program-controlled device outside the body) can be a doctor-programmed device (that is, a program-controlled device used by a doctor) or a patient-programmed device (that is, a program-controlled device used by a patient). The doctor's program-controlled device can be, for example, a tablet computer, a notebook computer, a desktop computer, a mobile phone and other smart terminal devices equipped with program-controlled software. The patient program-controlled device can be, for example, smart terminal devices such as tablet computers, notebook computers, desktop computers, and mobile phones equipped with program-controlled software, and the patient program-controlled device can also be other electronic devices with program-controlled functions (such as chargers with program-controlled functions, data collection device).

The embodiment of the present application does not limit the data interaction between the doctor's program-controlled device and the stimulator. When the doctor remotely programs, the doctor's program-controlled device can perform data interaction with the stimulator through the server and the patient's program-controlled device. When the doctor performs program control with the patient face-to-face offline, the doctor’s program-controlled device can interact with the stimulator through the patient’s program-controlled device, and the doctor’s program-controlled device can also directly interact with the stimulator.

In some optional embodiments, the patient programmable device may include a host (communicating with the server) and a slave (communicating with the stimulator), the host and slave being communicatively connected. Among them, the doctor's program-controlled equipment can exchange data with the server through the 3G/4G/5G network, the server can exchange data with the host through the 3G/4G/5G network, and the host can exchange data with the slave through the Bluetooth protocol/WIFI protocol/USB protocol. Interaction, the sub-machine can exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band, and the doctor's program-controlled equipment can directly exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band interact.

Referring to FIG. 1 to FIG. 4 , the embodiment of the present application provides an implantable stimulation system 10 , including a neurostimulator 100 installed inside the patient's cranium and an external programmer 200 installed outside the patient's body.

The external programmer 200 is used to provide the neural stimulator 100 with a programming signal for controlling the electrical stimulation therapy of the neural stimulator 100, and the neural stimulator 100 includes: a first group of stimulation contacts 131 to a fourth group The stimulation contacts 134 , the first to fourth stimulation sources 121 to 124 and the controller 111 .

The first group of stimulating contacts 131 and the second group of stimulating contacts 132 are arranged on the left brain, and the third group of stimulating contacts 133 and the fourth group of stimulating contacts 134 are arranged on the right brain.

Each of the stimulation sources is connected to one of the stimulation contacts in a one-to-one correspondence.

The controller 111 is respectively electrically connected to each of the stimulation sources, and the controller 111 is used for receiving the programming signal, generating at least two stimulation control signals and outputting each stimulation control signal to one or more the stimulation sources, and each of the stimulation sources only receives one of the stimulation control signals.

Each of the stimulation sources is used to receive the corresponding stimulation control signal, generate electrical stimulation and output to a corresponding group of the stimulation contacts, each group of the stimulation contacts is used to receive the electrical stimulation and The brain tissue corresponding to the contacts releases the energy corresponding to the electrical stimulation.

The extracorporeal programmer 200 can be used to receive the doctor's configuration operation on the electrical stimulation parameters of the neurostimulator 100 . The programming information may be the identification and parameter value of one or more parameters of the neural stimulator 100 corresponding to the configuration operation, such as the frequency parameter, pulse width parameter and amplitude parameter of electrical stimulation. In this embodiment, the values of the frequency parameter, pulse width parameter and amplitude parameter of electrical stimulation are not limited. When the parameter is the frequency parameter of electrical stimulation, the parameter value of the frequency parameter may be, for example, 110 Hz, 105 Hz and 100 Hz. When the parameter is a pulse width parameter of electrical stimulation, the parameter value of the pulse width parameter may be, for example, 70 μs, 80 μs and 90 μs. When the parameter is an amplitude parameter of electrical stimulation, the parameter values of the amplitude parameter may be, for example, 4.5V, 5V and 6V.

Referring to FIG. 1 , FIG. 1 is a schematic structural diagram of an implantable stimulation system provided by an embodiment of the present application. In a specific application, the doctor uses the implantable stimulation system 10 to perform targeted electrical stimulation therapy on different brain tissue positions corresponding to the left and right brains of the patient. The controller 111 receives the programming signal of the in vitro programmer 200, and generates a first stimulation control signal and a second stimulation control signal, the first stimulation source 121 and the fourth stimulation source 124 receive the first stimulation control signal, the second stimulation source 122 and The third stimulus source 123 receives the second stimulus control signal. The first stimulation source 121 and the fourth stimulation source 124 respectively generate electrical stimulation according to the first stimulation control signal and output to the first group of stimulation contacts 131 and the fourth group of stimulation contacts 134, the second stimulation source 122 and the third stimulation source 123 respectively generates electrical stimulation according to the second stimulation control signal and outputs it to the second group of stimulation contacts 132 and the third group of stimulation contacts 133 . The first group of stimulating contacts 131 and the second group of stimulating contacts 132 are arranged on the left brain, the third group of stimulating contacts 133 and the fourth group of stimulating contacts 134 are arranged on the right brain, through the first group of stimulating contacts 131 to the second The four groups of stimulation contacts 134 respectively release the energy corresponding to the electrical stimulation on the corresponding brain tissues of the stimulation contacts, and different electrical stimulations can be performed on the left and right brains of the patient at the same time, so as to obtain a suitable treatment plan for the patient. It should be noted that, in this application, as long as the stimulation source and the stimulation contact are connected in a one-to-one correspondence, any stimulation source can be connected to the first group of stimulation contacts 131, the second group of stimulation contacts 132, the third group of stimulation contacts, etc. contacts 133 or a fourth set of stimulation contacts 134 .

Therefore, without the need to implant multiple stimulators, electrical stimulation therapy can be performed on the left and right brains of the patient at the same time; in addition, the electrical stimulation energy released by the stimulation contacts can be generated under the control of different stimulation control signals, Different electrical stimulation energies can be released to different brain tissues for treatment. Thus, the above-mentioned embodiment implements a low-cost treatment plan for doctors to perform multiple electrical stimulations on multiple brain tissues of the left and right brains of patients, which greatly reduces the economic burden of patients and reduces the cost of implanting multiple stimulators in the patient's body. pain.

Referring to FIG. 2 , FIG. 2 is a schematic structural diagram of another implantable stimulation system provided by an embodiment of the present application. In some possible ways, the controller 111 can be used to generate a first stimulus control signal and output it to the first stimulus source 121 and the third stimulus source 123, and generate a second stimulus control signal and output it to The second stimulus source 122 and the fourth stimulus source 124 .

On the one hand, the left brain tissue and the right brain tissue can respectively realize electrical stimulation with two different energies; on the other hand, the first stimulation control signal and the second stimulation control signal are respectively output to the stimulation sources acting on the left and right brains. Thus, the patient can receive a balanced treatment of various electrical stimulations on the left and right brains.

Referring to FIG. 3 , FIG. 3 is a schematic structural diagram of another implantable stimulation system provided by an embodiment of the present application. In some possible ways, the controller 111 can also be used to generate a first stimulation control signal and output it to the first stimulation source 121, generate a second stimulation control signal and output it to the second stimulation source 122, A third stimulus control signal is generated and output to the third stimulus source 123 , and a fourth stimulus control signal is generated and output to the fourth stimulus source 124 .

In reality, people with severe obsessive-compulsive disorder and those who need detoxification often need to apply electrical stimulation to multiple parts of the brain tissue at the same time (the amplitude parameters of the required electrical stimulation are usually larger), and different parts of the left and right brains of the patient are treated separately. Unbalanced electrical stimulation therapy, on the one hand, can provide these patients with more energy electrical stimulation at the same time; good therapeutic effect.

In this case, the doctor can perform electrical stimulation on multiple brain tissues of the left and right brains of the patient, so as to meet the doctor's needs for diagnosis and treatment of some patients.

Therefore, the above setting can meet the needs of doctors to perform various electrical stimulation treatments on multiple brain tissues of the patient's left and right brains.

In some possible manners, the controller 111 may be used to control each stimulation source to cyclically generate electrical stimulation corresponding to various stimulation parameter combinations. According to the patient's symptoms, the doctor can formulate an electrical stimulation treatment plan that includes a combination of various stimulation parameters. If the electrical stimulation treatment is performed on the patient's brain tissue each time, the parameters must be set through the external program controller 200 one by one. It is easy to be restricted by the site, which is very inconvenient; and in the process of inputting treatment plan parameters, it is easy to misuse and bring unnecessary pain to the patient. The controller 111 controls each of the stimulation sources to cyclically generate electrical stimulation corresponding to a variety of stimulation parameter combinations, especially when the patient goes out and does not have the external programmer 200 around, the electrical stimulation can also be adjusted, which is more humane.

Therefore, without the program control of the external programmer 200, the stimulus source can be used to generate the electrical stimulation corresponding to the combination of stimulation parameters in a cycle through the controller 111, which is beneficial for patients to receive treatment anytime and anywhere.

Specifically, the value of at least one of the frequency parameter, pulse width parameter, amplitude parameter and time parameter of electrical stimulation corresponding to each stimulation parameter combination may be different. For example, in a combination of stimulation parameters, the time parameter is 1 second, the value of the frequency parameter of electrical stimulation is 110 Hz, the value of the pulse width parameter is 95 μs, and the values of the amplitude parameter are 5V and 5.1V. The amplitude parameter of electrical stimulation is switched every 1 second between 5V and 5.1V;

In another stimulation parameter combination, the time parameter is 2 seconds and 3 seconds, the value of the electrical stimulation frequency parameter is 100Hz and 110Hz, the value of the pulse width parameter is 60μs and 70μs, and the value of the amplitude parameter is 6V. The frequency parameters of electrical stimulation were switched every 2 seconds between 100Hz and 110Hz, and the pulse width parameters of electrical stimulation were switched every 3 seconds between 60μs and 70μs.

In yet another combination of stimulation parameters, the time parameters are 1 minute, 30 seconds and 1 second, the values of the frequency parameters of electrical stimulation are 90Hz and 110Hz, the values of the pulse width parameters are 80μs and 70μs, and the values of the amplitude parameters are are 4.9V and 5.1V. The frequency parameter of electrical stimulation is switched every 1 minute between 90Hz and 110Hz, the pulse width parameter is switched every 30 seconds between 80μs and 70μs, and the amplitude parameter is switched every 1 second between 4.9V and 5.1V switch.

Therefore, by combining the frequency parameters, pulse width parameters, amplitude parameters, and time parameters of electrical stimulation, a combination of stimulation parameters suitable for the patient can be obtained, and electrical stimulation therapy can be performed according to the combination of stimulation parameters to reduce the pain of the patient. Pain, improve the effect of electrical stimulation therapy for patients.

Referring to FIG. 4 , FIG. 4 is a schematic structural diagram of another implantable stimulation system provided by an embodiment of the present application. In some possible ways, the neural stimulator 100 may also include a plurality of stimulation leads 141 and a plurality of first switches 151 for connecting the stimulation source and the stimulation contacts, each of the stimulation contacts One of the stimulation leads 141 is connected to a corresponding stimulation source, and a first switch 151 is provided between each stimulation lead 141 and the stimulation source.

In a specific application, the stimulation contact can also be used as a collection contact of the implantable stimulation system for collecting EEG information at the location of the stimulation contact. The neural stimulator 100 may also include an EEG acquisition module and a plurality of acquisition leads and a plurality of second switches for connecting the EEG acquisition module and the stimulation contacts, each of the stimulation contacts passing through One of the collection leads is connected to a corresponding stimulation source, and a second switch is arranged between each collection lead and the stimulation source.

When the above-mentioned stimulation contact is used for electrical stimulation release, the first switch 151 arranged between the stimulation source and the stimulation lead 141 is turned on, and the second switch arranged between the EEG acquisition module and the acquisition lead is disconnected; when the above-mentioned When the stimulation contacts are used for collecting EEG information, the second switch disposed between the EEG collection module and the collection leads is turned on, and the first switch 151 disposed between the stimulation source and the stimulation leads 141 is turned off.

When a plurality of first switches 151 and second switches are provided, each stimulation contact can realize the function switching of brain signal acquisition and stimulation release through the first switch 151 and the second switch. Doctors can select useful stimulating contacts for electrical stimulation according to the collected EEG information, which reduces the pain of patients and improves the effect of treatment.

Thus, when the first switch 151 between the stimulation source and a stimulation lead 141 is turned on, the electrical stimulation generated by the stimulation source can be transmitted to the stimulation contact corresponding to the stimulation lead 141; When the first switch 151 is turned off, the electrical stimulation generated by the stimulation source cannot be transmitted to the stimulation contact corresponding to the stimulation lead 141 . Since the stimulating contacts corresponding to other stimulating leads 141 will not be affected, arranging multiple stimulating leads 141 and multiple first switches 151 can accurately control the electrical stimulation of the brain tissue of the patient to be treated.

A stimulation contact in this application may be a single electrode. Each group of stimulation contacts may include multiple ring-shaped electrodes, and may also include multiple sliced electrodes. Referring to FIG. 5 , FIG. 5 is a partial structural schematic diagram of a nerve stimulator provided in an embodiment of the present application. The segmented electrode 130 is an electrode obtained by segmenting the annular electrode. The segmented electrode 130 may be a multi-segment and multi-column electrode sheet arranged on a cylindrical toroidal surface. Compared with the circular electrodes, the electrical stimulation generated by the segmented electrodes 130 can be targeted at specific parts, reducing excessive treatment.

In some possible manners, the number of the stimulation contacts in each group of the stimulation contacts may be 4, 8 or 12. Referring to FIG. 5 , the stimulation contacts are patch electrodes 130 . When the number of stimulation contacts in each group of stimulation contacts is within the above-mentioned range, it is easy to select a suitable brain tissue target from multiple stimulation points, thereby achieving a better stimulation treatment effect. When the number of stimulation contacts is less than 4, the intensity of stimulation treatment is too small and the treatment effect is not good; when the number of stimulation contacts is greater than 12, it is necessary to set too many stimulation leads 141 to establish stimulation contacts and stimulation sources The connection increases the manufacturing difficulty and cost of the neurostimulator 100 .

Through the above-mentioned embodiment, the doctor can realize the electrical stimulation treatment of multiple stimulation contacts without implanting multiple stimulators to the patient, and the number of stimulation contacts is increased, so that the range of brain electrical stimulation is wider and the improvement is improved. Effects of brain stimulation therapy. Thus, the economic burden of the patient is greatly reduced, and the pain of implanting multiple stimulators in the patient's body is relieved.

In some possible manners, the brain tissues corresponding to the first group of stimulation contacts 131 to the fourth group of stimulation contacts 134 are the left anterior limb of the internal capsule, the left nucleus accumbens, the right forelimb of the internal capsule, and the right nucleus accumbens. Wherein, the brain tissue corresponding to the first group of stimulation contacts 131 is the left anterior limb of the internal capsule, the brain tissue corresponding to the second group of stimulation contacts 132 is the left nucleus accumbens, and the brain tissue corresponding to the third group of stimulation contacts 133 is the right inner capsule. For the forelimb of the capsule, the brain tissue corresponding to the fourth group of stimulation contacts 134 is the right nucleus accumbens.

The above-mentioned brain tissue can receive the corresponding energy released by the electrical stimulation of the stimulation contact point, and the therapeutic effect on the patient is better.

Therefore, when the electrical stimulation energy release area of the stimulation contact corresponds to the above-mentioned brain tissue, the therapeutic effect by electrical stimulation is good.

In some possible manners, the in vitro programmer 200 and the neural stimulator 100 are connected through two-way communication through the MICS frequency band. MICS (Medical Implant Communications Service) frequency band refers to the 402MHz to 405MHz frequency band.

Thus, when the in vitro program controller 200 and the neurostimulator 100 are connected by two-way communication through the MICS frequency band, the degree of attenuation of the communication signal propagating in the living body is small, thereby reducing the power consumption of the neurostimulator 100 and improving the performance of the neurostimulator. 100's of standby time.

In some possible manners, the communication mode between the external program controller 200 and the external program-controlled device is Bluetooth communication.

Therefore, the communication components corresponding to the Bluetooth communication are small in size and low in power consumption. When the communication mode between the external program controller 200 and the external program-controlled device is Bluetooth communication, the power consumption of the external program controller and the external program-controlled device can be reduced.

The types of diseases that the implantable stimulation system provided in this application can be used to treat or manage include any one or more of the following: spasticity disorder, pain, migraine, mental illness, bipolar disorder, anxiety disorder, post-traumatic stress disorder depression, obsessive-compulsive disorder, behavioral disorders, mood disorders, memory disorders, mental status disorders, mobility disorders, Huntington's disease, Alzheimer's disease, drug addiction, and other neurological or psychiatric disorders and impairments. Implantable stimulation systems can be used in the treatment or management of a variety of diseases and have a wide range of applications.

It should be noted that the terms "first" and "second" in the description and claims of the present application and the above drawings are configured to distinguish similar objects, but not necessarily configured to describe a specific order or sequence order. It is to be understood that the data so used are interchangeable under appropriate circumstances such that the embodiments of the application described herein can be practiced in sequences other than those illustrated or described herein. Furthermore, the terms "comprising" and "having", as well as any variations thereof, are intended to cover a non-exclusive inclusion, for example, a process, method, system, product or device comprising a sequence of steps or elements is not necessarily limited to the expressly listed instead, may include other steps or elements not explicitly listed or inherent to the process, method, product or apparatus.

When an element is referred to as being "on" or "over", "connected to" or "coupled to" another element, the element may be directly on, directly connected to, or Or directly bonded to the other component, or intermediate components may be present. However, when an element is referred to as being "directly on," "directly connected to," or "directly coupled to" another element, there are no intervening elements present. To this end, the term "connected" may refer to a physical connection, an electrical connection, etc., with or without intervening components.

Claims

An implantable stimulation system comprising:

A neurostimulator placed inside the patient's skull;

an external program controller arranged outside the body of the patient;

The extracorporeal programmer is used to provide the neural stimulator with a programming signal for controlling the neural stimulator to perform electrical stimulation therapy, and the neural stimulator includes:

The first group of stimulating contacts to the fourth group of stimulating contacts, the first group of stimulating contacts and the second group of stimulating contacts are arranged on the left brain, the third group of stimulating contacts and the fourth group of stimulating contacts are arranged in the right brain;

The first stimulation source to the fourth stimulation source, each of the stimulation sources is connected to one group of the stimulation contacts in a one-to-one correspondence;

a controller, the controller is electrically connected to each of the stimulation sources, and the controller is used to receive the programming signal, generate at least two stimulation control signals and output each stimulation control signal to one or more the stimulus sources, and each of the stimulus sources only receives one of the stimulus control signals;

Each of the stimulation sources is used to receive the corresponding stimulation control signal, generate electrical stimulation and output to a corresponding group of the stimulation contacts, each group of the stimulation contacts is used to receive the electrical stimulation and The brain tissue corresponding to the contacts releases the energy corresponding to the electrical stimulation.
The implantable stimulation system according to claim 1, wherein the controller is configured to generate a first stimulation control signal and output to the first stimulation source and the third stimulation source, and generate a second stimulation control signal and output to the second stimulus and the fourth stimulus.
The implantable stimulation system according to claim 1, wherein the controller is configured to generate a first stimulation control signal and output it to the first stimulation source, generate a second stimulation control signal and output it to the second stimulation source, A third stimulus control signal is generated and output to a third stimulus source, and a fourth stimulus control signal is generated and output to the fourth stimulus source.
The implantable stimulation system according to claim 1, wherein the controller is configured to control each of the stimulation sources to cyclically generate electrical stimulation corresponding to multiple stimulation parameter combinations.
The implantable stimulation system according to claim 4, wherein at least one of the frequency parameter, pulse width parameter, amplitude parameter and time parameter of electrical stimulation corresponding to each stimulation parameter combination has a different value.
The implantable stimulation system according to claim 1, wherein the neural stimulator further comprises a plurality of stimulation leads and a plurality of first switches for connecting the stimulation source and the stimulation contacts, each of the The stimulation contacts are connected to corresponding stimulation sources through one of the stimulation leads, and one first switch is arranged between each stimulation lead and the stimulation source.
The implantable stimulation system according to claim 1, wherein the number of the stimulation contacts in each group of the stimulation contacts is 4, 8 or 12.
The implantable stimulation system according to claim 1, wherein the brain tissues corresponding to the first group of stimulation contacts to the fourth group of stimulation contacts are the left anterior limb of the internal capsule, the left nucleus accumbens, the right internal Capsular forelimb and right nucleus accumbens.
The implantable stimulation system according to claim 1, wherein a two-way communication connection is carried out between the external programmer and the neural stimulator through the MICS frequency band.
The implantable stimulation system according to claim 1, wherein the type of disease that the implantable stimulation system is used to treat or manage includes any one or more of the following:

Spasticity disorders, pain, migraines, psychiatric disorders, bipolar disorder, anxiety disorders, post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder, behavioral disorders, mood disorders, memory disorders, mental status disorders, mobility disorders, Huntington's disease , Alzheimer's disease, and drug addiction.