WO2023011492A1

WO2023011492A1 - Implantable stimulator and stimulation system

Info

Publication number: WO2023011492A1
Application number: PCT/CN2022/109772
Authority: WO
Inventors: 刘鑫蕊; 王倩
Original assignee: 苏州景昱医疗器械有限公司
Priority date: 2021-08-03
Filing date: 2022-08-02
Publication date: 2023-02-09
Also published as: CN113426017A

Abstract

An implantable stimulator (100) and a stimulation system. The implantable stimulator (100) is provided in the body of a patient; the implantable stimulator (100) comprises a first stimulation generation module (111) to an Nth stimulation generation module, a first stimulation delivery module (121) to an Mth stimulation delivery module, and a first stimulation release module (131) to an Mth stimulation release module, wherein N is a positive integer greater than 1, and M is a positive integer not less than N; the ith stimulation generation module is used for generating electrical stimulation having an ith stimulation parameter combination; and the j stimulation release module is used for positions of a jth release position group close to the intracalvarium of the patient. At least two types of stimulation are simultaneously executed by means of the same stimulator (100), and the problem that multiple stimulation requirements can be satisfied only when a plurality of stimulators (100) are implanted into a patient is solved.

Description

Implantable stimulators and stimulation systems

This application claims the priority of the Chinese patent with application number 202110883399.2 filed on August 3, 2021, which is incorporated by reference in its entirety.

technical field

This application relates to the technical field of implantable medical equipment, in particular to an implantable stimulator and a stimulating system.

Background technique

In implantable medical devices, stimulators 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.

Existing implantable stimulators tend to implant the same electrodes for the patient. However, some patients may suffer from multiple diseases that require stimulation therapy, or the same patient has different nuclei (or brain tissues) of the same disease that require different degrees of stimulation therapy, so it is necessary to implant multiple stimulators in the patient's body , increasing the economic burden of the patient and the pain of implanting multiple stimulators in the body.

Contents of the invention

The purpose of this application is to provide an implantable stimulator and a stimulation system. The same stimulator performs at least two kinds of stimulation simultaneously, which solves the problem that a patient needs to implant multiple stimulators to meet various stimulation demands.

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

In a first aspect, the present application provides an implantable stimulator, the implantable stimulator is set in the body of a patient, and the implantable stimulator includes a first stimulation generating module to an Nth stimulation generating module, a first stimulating From the transfer module to the Mth stimulus delivery module and from the first stimulus release module to the Mth stimulus release module, N is a positive integer greater than 1, and M is a positive integer not less than N; the i-th stimulus generation module is used to generate the i-th stimulus The electrical stimulation of the parameter combination is recorded as the i-th electrical stimulation, and the value of i is each positive integer not greater than N; the j-th stimulation release module is used for one or A plurality of positions, the jth stimulus release module is used to connect to the kth stimulus generation module through the jth stimulus delivery module, receive the kth electrical stimulus and release the jth electrical stimulus to one or more positions of the jth release position group For the energy corresponding to the kth electrical stimulation, the value of j is each positive integer not greater than M, and the value of k is any positive integer not greater than N.

The beneficial effect of this technical solution is that for patients suffering from a variety of diseases that require electrical stimulation therapy, at least two stimulations can be performed on the patient at the same time through the same implanted stimulator, which reduces the economic burden of the patient and reduces the burden on the patient. The pain of having multiple stimulators implanted in the patient's body. In addition, the same implantable stimulator can assist doctors to perform different stimulation instructions for different diseases or symptoms at the same time, and doctors have more treatment options according to the patient's condition.

In a possible implementation manner, the i-th stimulus generation module is configured to receive a program control instruction sent by a program-controlled device, and determine the i-th stimulus parameter combination based on the program control command. The beneficial effect of this technical solution is that when a doctor treats a patient who needs multiple electric stimulation treatments, he can configure the stimulation parameters required for treatment through the program-controlled device, and implement different stimulation treatment plans.

In a possible implementation, N=2, M=4; the first stimulus release module is used to connect to the first stimulus generation module through the first stimulus transmission module; the second stimulus release module is used to connect to the first stimulus generation module through The second stimulus delivery module is connected to the first stimulus generation module; the third stimulus release module is used to connect to the second stimulus generation module through the third stimulus delivery module; the fourth stimulus release module is used to pass the fourth stimulus delivery The module is connected to a second stimulus generation module. The beneficial effect of this technical solution is that it can meet the doctor's requirement of performing electrical stimulation therapy on two nuclei (or brain tissue) according to the patient's needs.

In a possible implementation manner, the first stimulation release module is used to be close to one or more positions of the first release position group of the patient's intracranial left brain; the second stimulation release module is used to be close to all One or more positions of the second release position group of the patient's intracranial right brain; the third stimulus release module is used to be close to one or more positions of the third release position group of the patient's intracranial left brain; The fourth stimulus release module is used for one or more positions of the fourth release position group close to the patient's intracranial right brain. The beneficial effect of the technical solution is that it can meet the needs of doctors to deal with many diseases requiring simultaneous and identical electrical stimulation of the left brain and the right brain.

In a possible implementation, N=2, M=3; the first stimulus release module is used to connect to the first stimulus generation module through the first stimulus transmission module; the second stimulus release module is used to connect to the first stimulus generation module through The second stimulus delivery module is connected to the first stimulus generation module; the third stimulus release module is used to connect to the second stimulus generation module through the third stimulus delivery module. The beneficial effect of this technical solution is that it can satisfy the situation that doctors only need to stimulate one nucleus (or brain tissue) to deal with many diseases.

In a possible implementation, the implantable stimulator further includes a first to Qth EEG acquisition module, a first to a Qth EEG transmission module, and an EEG receiving module , Q is a positive integer; the p-th EEG acquisition module is used to collect the EEG information of one or more positions in the p-th acquisition position group, which is recorded as the p-th EEG information, and pass the p-th EEG information through the p-th EEG information The transmitting module sends to the EEG receiving module, and the values of p are each positive integer not greater than Q. The beneficial effect of the technical solution is that the doctor can selectively treat according to the collected EEG information and the disease that the patient needs to be treated by electrical stimulation, which reduces the suffering of the patient and improves the treatment effect.

In a possible implementation manner, Q=M, the i-th EEG acquisition module is close to the i-th stimulation release module, and the i-th EEG acquisition module and the i-th stimulation release module are separated by Insulation. The beneficial effect of the technical solution is that more accurate data feedback can be obtained during the electrical stimulation treatment, which can assist the doctor to adjust the electrical stimulation parameters of the implanted stimulator in a targeted manner.

In a second aspect, the present application provides an implantable stimulator, the implantable stimulator is set in the body of a patient, and the implantable stimulator includes a first stimulation generation module to an Nth stimulation generation module and a first stimulation generation module. From the release module to the Mth stimulation release module, N is a positive integer greater than 1, and M is a positive integer not less than N; the i-th stimulation generation module is used to be set in the patient's cranium, and the i-th stimulation generation module is used for Generate electrical stimulation with the ith stimulation parameter combination, denoted as the i-th electrical stimulation, the value of i is each positive integer not greater than N; the jth stimulation release module is used for the jth release near the patient's cranium One or more positions of the position group, the jth stimulus release module is used to connect to the kth stimulus generation module, receive the kth electrical stimulus and release the first electrical stimulus to one or more positions of the jth release position group The energy corresponding to k electrical stimulation, the value of j is each positive integer not greater than M, and the value of k is any positive integer not greater than N.

In a possible implementation manner, the i-th stimulus generation module is configured to receive a program control instruction sent by a program-controlled device, and determine the i-th stimulus parameter combination based on the program control command.

In a possible implementation, N=2, M=4; the first stimulus release module is used to connect to the first stimulus generation module; the second stimulus release module is used to connect to the first stimulus generation module ; the third stimulus release module is used to connect to the second stimulus generation module; the fourth stimulus release module is used to connect to the second stimulus generation module.

In a possible implementation manner, the first stimulation release module is used to be close to one or more positions of the first release position group of the patient's intracranial left brain; the second stimulation release module is used to be close to all One or more positions of the second release position group of the patient's intracranial right brain; the third stimulus release module is used to be close to one or more positions of the third release position group of the patient's intracranial left brain; The fourth stimulus release module is used for one or more positions of the fourth release position group close to the patient's intracranial right brain.

In a possible implementation, N=2, M=3; the first stimulus release module is used to connect to the first stimulus generation module; the second stimulus release module is used to connect to the first stimulus generation module ; the third stimulus release module is used to connect to the second stimulus generation module.

In a possible implementation, the implantable stimulator further includes a first to Qth EEG acquisition module and an EEG receiving module, where Q is a positive integer; the pth EEG acquisition module is used to acquire The EEG information of one or more positions of the p-th collection position group is recorded as the p-th EEG information, and the p-th EEG information is sent to the EEG receiving module, and the value of p is not greater than Q respectively. Every positive integer.

In a possible implementation manner, Q=M, the i-th EEG acquisition module is close to the i-th stimulation release module, and the i-th EEG acquisition module and the i-th stimulation release module are separated by Insulation. .

In a third aspect, the present application provides a stimulation system, the stimulation system includes the implantable stimulator described in any one of the above; the stimulation system also includes a program-controlled device, and the program-controlled device is used to receive a program-controlled configuration operation , generating programmed instructions and sending them to the implantable stimulator.

In a possible implementation manner, the program-controlled device includes a doctor device and a program controller; the doctor device is configured to receive the program-controlled configuration operation, generate the program-controlled instruction and send it to the program controller; and sending the programmed instructions to the implantable stimulator.

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 stimulator provided in an embodiment of the present application;

Fig. 2 is a schematic structural diagram of another implantable stimulator provided in the embodiment of the present application;

Fig. 3 is a schematic structural diagram of another implantable stimulator provided in the embodiment of the present application;

Fig. 4 is a schematic structural diagram of another implantable stimulator provided in the embodiment of the present application;

Fig. 5 is a schematic structural diagram of another implantable stimulator provided in the embodiment of the present application;

Fig. 6 is a schematic structural diagram of another implantable stimulator provided in the embodiment of the present application;

Fig. 7 is a partial structural schematic diagram of an implantable stimulator provided in an embodiment of the present application;

Fig. 8 is a schematic structural diagram of another implantable stimulator provided in the embodiment of the present application;

Fig. 9 is a schematic structural diagram of a stimulation system provided by an embodiment of the present application.

Illustration: 100, implantable stimulator; 200, program-controlled equipment; 110, stimulation generating module; 120, stimulation transmission module; 130, stimulation release module; 160 EEG receiving module; The fifth stimulus generation module; 121-128, the first stimulus transmission module to the eighth stimulus transmission module; 131-138, the first stimulus release module to the eighth stimulus release module; 141-144, the first EEG acquisition module to the eighth stimulus release module Four EEG acquisition modules; 151-154, first to fourth EEG transmission modules; 210, doctor equipment; 220, program controller.

Detailed ways

Below, the present application will be further described in conjunction with the accompanying drawings and specific implementation methods. It should be noted that, on the premise of not conflicting, the various embodiments described below or the technical features can be combined arbitrarily to form a new embodiment. .

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 simultaneously, 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 illustration. 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 of the embodiments of the present application (that is, implantable medical devices) will be briefly described.

An implantable neurostimulation system (an implantable medical system) mainly includes a stimulator implanted in a patient (ie, an implantable stimulator) and a program-controlled device installed outside the patient's body. The existing 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 corresponding neural structures and networks. Electrical activity and its function, 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 I DDS) 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 stimulations to specific areas of tissues in the body. The extension lead 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 lead. Electrode leads deliver electrical stimulation to specific areas of tissue in the body through multiple electrode 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 patient's disease type is different, the stimulated site is generally different, the number of stimulation contacts used (single source or multi-source), one or more channels (single-channel or multi-channel) specific electrical stimulation signals The application and stimulus parameter data are also 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 at least one of the following: frequency (for example, the number of electrical stimulation pulse signals per unit time 1s, the unit is Hz), pulse width (the duration of each pulse, the unit is μs), amplitude (generally used Voltage expression, 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) , The upper and lower limits of the doctor's control (the range that can be adjusted by the doctor) and the upper and lower limits of the patient's control (the range that can be adjusted by the patient).

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

The program-controlled device may be a doctor-programmed device (ie, a program-controlled device used by a doctor) or a patient-programmed device (ie, 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. 6 , FIG. 1 is a schematic structural diagram of an implantable stimulator provided in an embodiment of the present application. Embodiment 1 provides an implantable stimulator 100, the implantable stimulator 100 is set in the body of the patient, the implantable stimulator 100 includes a first stimulus generating module 111 to an Nth stimulus generating module, a first Stimulus delivery module 121 to the Mth stimulus delivery module and the first stimulus release module 131 to the Mth stimulus release module, N is a positive integer greater than 1, and M is a positive integer not less than N; the i-th stimulus generation module is used to generate The electrical stimulation of the i stimulation parameter combination is denoted as the i electrical stimulation, and the value of i is each positive integer not greater than N; the j stimulation release module is used for the j release position group close to the patient's cranium One or more positions of the jth stimulus release module is used to connect to the kth stimulus generation module through the jth stimulus transmission module, receive the kth electrical stimulus and release one or more positions of the jth position group The energy corresponding to the kth electrical stimulation is released, the value of j is each positive integer not greater than M, and the value of k is any positive integer not greater than N.

In the embodiment of the present application, each stimulus release module corresponds to a stimulus transmission module, and each stimulus release module is connected to one of the stimulus generation modules through a stimulus release module. Each stimulus generation module may correspond to 0, 1 or more stimulus release modules.

Each set of release locations may include one or more locations, for example 2, 3, 4, 6, 8, 12, etc.

In order to achieve the purpose of stimulation therapy for different brain tissue locations, the ratio of the stimulation generation module 110 and the stimulation release module 130 acting on the patient for stimulation therapy may include but not limited to 2:2, 2:3, 2:4 , 3:6, 5:8.

In a specific implementation, N is 2, 3, 4, for example. When N=2, M is 2, 3, 4, 5, for example. When N=3, M is 3, 4, 5, 6, for example. When N=4, M is 4, 5, 6, 7, 8, 9, for example.

Referring to FIG. 4 , FIG. 4 is a schematic structural diagram of another implantable stimulator provided in an embodiment of the present application. In some possible ways, N=3, M=5. At this time, the values of i are 1, 2, 3 respectively, the values of j are 1, 2, 3, 4, 5 respectively, and the values of k may be 1, 2, 3, for example. The doctor performs electrical stimulation therapy on patient A who needs to be treated for depression, obsessive-compulsive disorder and bipolar disorder at the same time, and implants an implanted stimulator 100 in patient A, and the implanted stimulator 100 includes three stimulation generating modules , five stimulus delivery modules and five stimulus release modules.

The first stimulation generation module 111 is used to generate electrical stimulation with a voltage of 1.5V, a frequency of 110 Hz, and a pulse width of 70 μs, which is recorded as the first electrical stimulation, and is used to treat the depression of patient A.

The second stimulation generating module 112 is used to generate electrical stimulation with a voltage of 1.8V, a frequency of 90 Hz, and a pulse width of 95 μs, which is referred to as the second electrical stimulation, and is used to treat patient A's obsessive-compulsive disorder.

The third stimulation generation module 113 is used to generate an electrical stimulation with a voltage of 1.8V, a frequency of 120 Hz, and a pulse width of 80 μs, which is referred to as the third electrical stimulation, and is used for treating bipolar disorder of a patient.

The first stimulus release module 131 is used to be close to one or more positions of the first group of release positions in the patient's cranium, and the first stimulus release module 131 is used to be connected to the first stimulus generator through the first stimulus delivery module 121 Module 111, receiving a first electrical stimulus and releasing energy corresponding to the first electrical stimulus to one or more positions of the first release position group.

The second stimulus delivery module 132 is configured to be close to one or more locations of the second set of delivery locations within the patient's cranium, the second stimulus delivery module 132 is configured to be connected to the first stimulus generating module 122 via the second stimulus delivery module 122 . Module 111, receiving the first electrical stimulation and releasing energy corresponding to the first electrical stimulation to one or more positions of the second release position group.

The third stimulus release module 133 is used to be close to one or more positions of the third release position group in the patient's cranium, and the third stimulus release module 133 is used to be connected to the second stimulus generator through the third stimulus delivery module 123 Module 112, receiving a second electrical stimulus and releasing energy corresponding to the second electrical stimulus to one or more positions of the third release position group.

The fourth stimulus delivery module 134 is configured to be close to one or more locations of the fourth delivery location group in the patient's cranium, and the fourth stimulus delivery module 134 is configured to be connected to the third stimulus generating module 124 through the fourth stimulus delivery module 124. Module 113, receiving the third electrical stimulation and releasing energy corresponding to the third electrical stimulation to one or more positions of the fourth release position group.

The fifth stimulus delivery module 135 is configured to be close to one or more locations of the fifth release location group in the patient's cranium, and the fifth stimulus delivery module 135 is configured to be connected to the third stimulus generating module 125 via the fifth stimulus delivery module 125. Module 115, receiving a fifth electrical stimulus and releasing energy corresponding to the third electrical stimulus to one or more positions of the fifth release position group.

Therefore, doctors can treat depression, obsessive-compulsive disorder and bipolar disorder at the same time through one implanted stimulator 100 .

Therefore, for patients suffering from various diseases that require electrical stimulation therapy, at least two kinds of stimulation can be performed on the patient at the same time through the same implantable stimulator 100, which greatly reduces the economic burden of the patient and relieves the patient's body weight. The pain of implanting multiple stimulators. The same implantable stimulator 100 can assist doctors to simultaneously execute different stimulation instructions for different diseases or symptoms, giving doctors more treatment options according to the patient's condition.

In some possible manners, the i-th stimulus generation module may be configured to receive a program control instruction sent by the program-controlled device 200, and determine the i-th stimulus parameter combination based on the program control command. Wherein, the program-controlled device 200 includes one or more of an external program-controlled instrument, an external program-controlled device, a tablet computer, a notebook computer, a desktop computer, a mobile phone, and a smart wearable device. In the embodiment of the present application, the program-controlled device 200 is configured to receive a doctor's configuration operation on stimulator parameters, and the program-controlled information may be the identification and parameter value of one or more stimulator parameters corresponding to the configuration operation. The in vitro program control instrument is, for example, the in vitro program control instrument disclosed in patent CN105709336B, or the implantable neural stimulator program control instrument disclosed in patent CN207412517U. The in vitro program controller is, for example, a program controller in an implantable nerve electrical pulse stimulation system disclosed in patent CN100469401C, or a doctor program controller with security and confidentiality functions disclosed in patent CN201894778U.

Each stimulation parameter combination in the embodiment of the present application may include identification and parameter values of one or more stimulation parameters. Stimulation parameters may include one or more of voltage, current, frequency, and pulse width. In some possible ways, a combination of stimulation parameters is, for example: voltage is 1.0V; frequency is 90Hz. In another specific application scenario, a combination of stimulation parameters is, for example: a voltage of 1.1V; a frequency of 110 Hz; and a pulse width of 80 μs.

In this case, the ith stimulation parameter combination may be different combinations of current or voltage amplitude, and in the case of stimulation pulses, pulse rate and pulse width. Therefore, when a doctor treats a patient who needs multiple electrical stimulation treatments, he can configure the stimulation parameters required for treatment through the program-controlled device 200 to implement different stimulation treatment plans.

Referring to FIG. 2 , FIG. 2 is a schematic structural diagram of another implantable stimulator provided in an embodiment of the present application. In some possible ways, N=2, M=4. At this time, the values of i are 1 and 2 respectively, the values of j are 1, 2, 3 and 4 respectively, and the values of k may be 1 and 2, for example.

The first stimulus release module 131 is used to connect to the first stimulus generation module 111 through the first stimulus transmission module 121;

The second stimulus release module 132 is used to connect to the first stimulus generation module 111 through the second stimulus delivery module 122;

The third stimulus release module 133 is used to be connected to the second stimulus generation module 112 through the third stimulus delivery module 123;

The fourth stimulus release module 134 is used to connect to the second stimulus generation module 112 through the fourth stimulus delivery module 124 .

In some possible ways, the doctor treats patient B suffering from depression and Parkinson's disease, and needs to perform electrical stimulation on the two nuclei positions related to the treatment of depression, and to the two nuclei related to the treatment of Parkinson's disease. The first stimulation generation module 111 of the implantable stimulator 100 in the patient's body is used to receive the treatment instruction for Parkinson's disease sent by the program control device 200 to generate the first electrical stimulation and transmit it to the first The stimulus release module 131 and the third stimulus release module 133, the second stimulus generation module 112 is used to receive the treatment instruction for depression sent by the program-controlled device 200 to generate the second electrical stimulation and transmit it to the second stimulus release module 132 and the second stimulus release module 132. The fourth stimulus release module 134 implements the treatment of Parkinson's disease and depression for patient B at the same time. In this way, it can meet the doctor's requirement of stimulating the two nuclei (or brain tissue) for the patient.

In some possible ways, the first stimulus release module 131 can be used for one or more positions of the first release position group close to the patient's intracranial left brain; the second stimulus release module 132 can be used for One or more positions of the second release position group close to the patient's intracranial right brain; the third stimulus release module 133 can be used for one or more positions of the third release position group close to the patient's intracranial left brain locations; the fourth stimulus release module 134 can be used for one or more locations of the fourth group of release locations close to the patient's intracranial right brain.

In some possible ways, doctors treat patients with depression and Parkinson's disease at the same time. Doctors need to apply 1.1V voltage, 110Hz Electrical stimulation with frequency and pulse width of 90μs is used to treat Parkinson's disease, and electrical stimulation with 1.3V voltage and 90Hz frequency is performed on the two nuclei of the patient's left brain and right brain related to the treatment of depression. Thus, it can meet the needs of doctors to treat patients with many diseases requiring simultaneous and identical electrical stimulation of the left brain and the right brain.

Referring to FIG. 3 , FIG. 3 is a schematic structural diagram of another implantable stimulator provided in an embodiment of the present application. In some possible ways, N=2, M=3; at this time, the values of i are 1, 2 respectively, the values of j are 1, 2, 3 respectively, and the values of k can be 1, 2, for example . The first stimulus release module 131 can be used to be connected to the first stimulus generating module 111 through the first stimulus delivery module 121; the second stimulus release module 132 can be used to be connected to the first stimulus delivery module 122 through the second stimulus The generating module 111 ; the third stimulus releasing module 133 can be used to connect to the second stimulus generating module 112 through the third stimulus transmitting module 123 .

In some possible ways, doctors treat patients with obsessive-compulsive disorder and Parkinson's disease. According to the diagnosis information, doctors need to apply 1.1V voltage to the two nuclei of the patient's left brain and right brain related to the treatment of Parkinson's disease , 110Hz frequency and 90μs pulse width electrical stimulation to treat Parkinson's disease; 1.3V voltage and 90Hz frequency electrical stimulation to a nucleus of the patient's left brain related to the treatment of obsessive-compulsive disorder to treat obsessive-compulsive disorder . Thus, it can meet the needs of doctors to treat patients with many diseases requiring simultaneous and identical electrical stimulation of the left brain and the right brain. Thus, it can meet the situation that doctors only need to stimulate one nucleus (or brain tissue) for many diseases.

In some possible ways, the implantable stimulator 100 may also include the first EEG acquisition module 141 to the Qth EEG acquisition module, the first EEG transmission module 151 to the Qth EEG transmission module, and the EEG In the receiving module 160, Q is a positive integer; the p-th EEG acquisition module can be used to collect the EEG information of one or more positions of the p-th acquisition position group, which is recorded as the p-th EEG information, and the p-th EEG information is passed through The pth EEG transmitting module sends to the EEG receiving module 160, and the value of p is each positive integer not greater than Q.

Referring to FIG. 7 , FIG. 7 is a partial structural diagram of an implantable stimulator provided in an embodiment of the present application. In some possible manners, Q=4, and the values of p are 1, 2, 3, and 4 respectively. The EEG information collected by the first EEG collection module 141 at the first collection position group is sent to the EEG receiving module 160 through the first EEG transmission module 151; The collected EEG information is sent to the EEG receiving module 160 through the first EEG transmission module 152; the EEG information collected by the first EEG collection module 143 in the first collection position group is passed through the first EEG transmission module 153 to the EEG receiving module 160 ; the EEG information collected by the first EEG collecting module 144 at the first collection position group is sent to the EEG receiving module 160 through the first EEG transmission module 154 .

Doctors treat patients with Parkinson's disease and obsessive-compulsive disorder. According to the received EEG information, doctors can judge that the first collection position group and the second collection position group are suitable for treatment according to the Parkinson's disease treatment plan, and the third collection position group The position group and the fourth acquisition position group are suitable for treatment according to the treatment plan for obsessive-compulsive disorder. According to the judgment results of the patient's condition and the EEG information collected by the EEG acquisition module, the doctor performs electrical stimulation therapy for Parkinson's disease in the first and second collection location groups, and in the third and fourth collection location groups. Collect location groups for electrical stimulation therapy for obsessive-compulsive disorder. Thus, the doctor can selectively treat according to the collected EEG information and the disease that the patient needs electrical stimulation treatment, which reduces the pain of the patient and improves the effect of treatment.

In some possible manners, Q=M, the i-th EEG acquisition module is close to the i-th stimulation release module, and the i-th EEG acquisition module is insulated from the i-th stimulation release module . Among them, the EEG signals of the brain regions affected by each stimulus release module can be mastered by doctors, and doctors can carry out targeted treatment for patients according to the mastered EEG signals. In this way, more accurate data feedback can be obtained during the stimulation treatment, which can assist the doctor to adjust the electrical stimulation parameters of the implantable stimulator 100 in a targeted manner.

In a specific implementation, the stimulus release module 130 and the EEG acquisition module can be integrated into one. The stimulus release module 130 can be a macro electrode with a large size, and the EEG acquisition module can be a micro electrode with a small size, and the micro electrode can be arranged inside (central or non-central) or around the macro electrode. Referring to Fig. 1, in some possible ways, N=2, M=2. At this time, the values of i are 1 and 2 respectively, the values of j are 1 and 2 respectively, and the values of k may be 1 and 2, for example.

The first stimulus release module 131 is used to connect to the first stimulus generation module 111 through the first stimulus transmission module 121 .

The second stimulus release module 132 is used to connect to the second stimulus generation module 112 through the second stimulus delivery module 122 .

Referring to Fig. 5, in some possible manners, N=5, M=8. At this time, the values of i are 1, 2, 3, 4, 5 respectively, the values of j are 1, 2, 3, 4, 5, 6, 7, 8 respectively, and the values of k can be, for example, 1, 2, 3, 4.

The third stimulus releasing module 133 is used to connect to the second stimulus generating module 112 through the third stimulus transmitting module 123 .

The fourth stimulus release module 134 is used to connect to the third stimulus generation module 113 through the fourth stimulus delivery module 124 .

The fifth stimulus release module 135 is used to connect to the third stimulus generation module 113 through the fifth stimulus delivery module 125 .

The sixth stimulus release module 136 is used to connect to the fourth stimulus generation module 114 through the sixth stimulus delivery module 126 .

The seventh stimulus release module 137 is used to connect to the fourth stimulus generation module 114 through the seventh stimulus delivery module 127 .

The eighth stimulus release module 138 is used to connect to the fifth stimulus generation module 115 through the eighth stimulus delivery module 128 .

Referring to FIG. 8 , FIG. 8 is a schematic structural diagram of another implantable stimulator provided in an embodiment of the present application. Embodiment 2 provides an implantable stimulator 100, the implantable stimulator 100 is set in the body of a patient, the implantable stimulator 100 includes a first stimulus generating module 111 to an Nth stimulus generating module and a first The stimulus release module 131 to the Mth stimulus release module, N is a positive integer greater than 1, and M is a positive integer not less than N; the i-th stimulus generation module is used to be set in the patient's cranium, and the i-th stimulus generation module It is used to generate the electrical stimulation with the ith stimulation parameter combination, which is denoted as the i-th electrical stimulation, and the value of i is each positive integer not greater than N; the j-th stimulation release module is used for the One or more positions of the jth release position group, the jth stimulus release module is used to connect to the kth stimulus generation module, receive the kth electrical stimulus and release the kth electrical stimulus to one or more positions of the jth release position group The energy corresponding to the kth electrical stimulation, the value of j is each positive integer not greater than M, and the value of k is any positive integer not greater than N.

FIG. 8 shows an implantable stimulator 100 with N=3, M=6.

In some possible manners, the i-th stimulus generation module may be configured to receive a program control instruction sent by the program-controlled device 200, and determine the i-th stimulus parameter combination based on the program control command.

In some possible ways, N=2, M=4; the first stimulus release module 131 can be connected to the first stimulus generation module 111; the second stimulus release module 132 can be connected to the first stimulus generation module 111 ; the third stimulus release module 133 can be connected to the second stimulus generation module 112 ; the fourth stimulus release module 134 can be connected to the second stimulus generation module 112 .

In some possible ways, N=2, M=3; the first stimulus release module 131 can be connected to the first stimulus generation module 111; the second stimulus release module 132 can be connected to the first stimulus generation module 111 ; The third stimulus release module 133 may be connected to the second stimulus generation module 112 .

In some possible ways, the implantable stimulator 100 may also include the first EEG acquisition module 141 to the Qth EEG acquisition module and the EEG receiving module 160, Q is a positive integer; To collect the EEG information of one or more positions of the p-th collection position group, record it as the p-th EEG information, and send the p-th EEG information to the EEG receiving module 160, and the values of p are respectively Every positive integer greater than Q.

In some possible manners, Q=M, the i-th EEG acquisition module is close to the i-th stimulation release module, and the i-th EEG acquisition module is insulated from the i-th stimulation release module .

Referring to FIG. 9 , Embodiment 3 provides a stimulation system, the stimulation system includes the implantable stimulator 100 described in any one of the above; the stimulation system also includes a program-controlled device 200, and the program-controlled device 200 is used for The programmed configuration operation is received, and programmed instructions are generated and sent to the implantable stimulator 100 .

In some possible manners, the program-controlled device 200 may include a doctor device 210 and a programmer 220; the doctor device 210 is configured to receive the program-controlled configuration operation, generate the program-controlled instruction and send it to the programmer 220; The programmer 220 is used to send the programming instructions to the implantable stimulator 100 . The doctor device 210 is, for example, a mobile phone, a tablet computer, a computer, a smart wearable device or other smart terminal devices. An app related to configuring stimulator parameters can be run on the doctor device 210, and multiple function buttons can be set in the app. Use these function buttons to receive control operations to change the parameter configuration interface, thereby changing the stimulation parameters.

The control operation may include one or more of start, pause, resume, stop, reset and gesture operations. Gesture operations may include contact gesture operations and/or air gesture operations.

The contact gesture operation may include, for example, one or more of a contact gesture swipe up, a contact gesture swipe down, a short press, a long press, and a contact gesture slide inward from an edge (upper, lower, left or right).

The air gesture operation may include, for example, an air grab gesture; one or more of an air gesture swipe left, an air gesture swipe right, an air gesture swipe up, and an air gesture swipe down. .

For example, when the touch gesture operation is a touch gesture swipe up, increase the parameter value of the selected configuration parameter in the parameter configuration interface; when the touch gesture operation is a touch gesture swipe down, return to the previous operation; When the air gesture operation is a grab gesture, the current configuration parameters are saved; when the air gesture operation is a short press, the configuration page is opened.

Therefore, when a doctor treats a patient who needs a variety of electrical stimulation treatments, he only needs one implanted stimulator to receive the program control instructions, and can configure the stimulation parameters required for treatment through the program control device 200 to implement different stimulations. Treatment programs.

This application is elaborated from the perspectives of purpose of use, performance, progress and novelty. The above description and accompanying drawings of this application are only preferred embodiments of this application, and are not intended to limit this application. Therefore, all All structures, devices, features, etc. that are similar or identical to those of the present application, that is, all equivalent replacements or modifications made according to the scope of the patent application of the present application, shall fall within the scope of protection of the patent application of the present application.

Claims

An implantable stimulator, the implantable stimulator is set in the body of a patient, the implantable stimulator includes a first stimulation generation module to an Nth stimulation generation module, a first stimulation transmission module to an Mth stimulation transmission module And the first stimulation release module to the Mth stimulation release module, N is a positive integer greater than 1, and M is a positive integer not less than N;

The i-th stimulation generation module is used to generate electrical stimulation with the i-th stimulation parameter combination, which is denoted as the i-th electrical stimulation, and the value of i is each positive integer not greater than N;

The jth stimulus release module is used to be close to one or more positions of the jth release position group in the patient's cranium, the jth stimulus release module is used to connect to the kth stimulus generation module through the jth stimulus transmission module, receiving The k-th electrical stimulation and release the energy corresponding to the k-th electrical stimulation to one or more positions of the j-th release position group, the value of j is each positive integer not greater than M, and the value of k is Any positive integer not greater than N.
The implantable stimulator according to claim 1, wherein the i-th stimulus generation module is configured to receive a program control instruction sent by a program-controlled device, and determine the i-th stimulation parameter combination based on the program control command.
The implantable stimulator according to claim 1, wherein N=2, M=4;

The first stimulus release module is configured to be connected to the first stimulus generation module through the first stimulus delivery module;

The second stimulus release module is configured to be connected to the first stimulus generation module through a second stimulus delivery module;

The third stimulus release module is configured to be connected to the second stimulus generation module through a third stimulus delivery module;

The fourth stimulus release module is used to connect to the second stimulus generation module through the fourth stimulus delivery module.
The implantable stimulator of claim 3, wherein the first stimulation delivery module is for one or more locations of a first set of delivery locations near the patient's intracranial left brain;

the second stimulus delivery module for one or more locations of a second set of delivery locations proximate to the patient's intracranial right brain;

said third stimulus delivery module for one or more locations of a third set of delivery locations proximate to the patient's intracranial left hemisphere;

The fourth stimulus delivery module is for one or more locations of a fourth set of delivery locations proximate to the patient's intracranial right brain.
The implantable stimulator according to claim 1, wherein, N=2, M=3;

The first stimulus release module is configured to be connected to the first stimulus generation module through the first stimulus delivery module;

The second stimulus release module is configured to be connected to the first stimulus generation module through a second stimulus delivery module;

The third stimulus release module is used to connect to the second stimulus generation module through the third stimulus delivery module.
The implantable stimulator according to claim 1, wherein the implantable stimulator further comprises the first to the Qth EEG acquisition module, the first to the Qth EEG transmission module, and the first to the Qth EEG transmission module. module and the EEG receiving module, Q is a positive integer;

The p-th EEG acquisition module is used to collect the EEG information of one or more positions of the p-th acquisition position group, which is recorded as the p-th EEG information, and send the p-th EEG information to all In the EEG receiving module, the value of p is each positive integer not greater than Q.
The implantable stimulator according to claim 6, wherein, Q=M, the i-th EEG acquisition module is close to the i-th stimulation release module, and the i-th EEG acquisition module is close to the i-th EEG acquisition module The stimulus release modules are insulated.
An implantable stimulator, the implantable stimulator is set in the body of a patient, the implantable stimulator includes a first stimulus generating module to an Nth stimulus generating module and a first stimulus releasing module to an Mth stimulus releasing module , N is a positive integer greater than 1, M is a positive integer not less than N;

The i-th stimulation generation module is used to be installed in the patient's cranium, and the i-th stimulation generation module is used to generate the electrical stimulation with the i-th stimulation parameter combination, denoted as the i-th electrical stimulation, and the value of i is not greater than each positive integer of N;

The jth stimulation release module is used to be close to one or more positions of the jth release position group in the patient's cranium, the jth stimulation release module is used to connect to the kth stimulation generation module, receive the kth electrical stimulation and One or more positions of the j-th release position group release the energy corresponding to the k-th electrical stimulation, the value of j is each positive integer not greater than M, and the value of k is any one not greater than N positive integer.
A stimulation system, comprising the implantable stimulator according to any one of claims 1-7 or the implantable stimulator according to claim 8;

The stimulation system also includes a program-controlled device, which is used to receive a program-controlled configuration operation, generate a program-controlled command and send it to the implantable stimulator.
The stimulation system of claim 9, wherein the programmed device comprises a doctor's device and a programmer;

The doctor equipment is used to receive the program-controlled configuration operation, generate the program-controlled instruction and send it to the program controller;

The programmer is used to send the programming instructions to the implantable stimulator.