Electrode wire, stimulator system, and computer-readable storage medium

Abstract

An electrode wire, a stimulator system, and a computer-readable storage medium. The electrode wire comprises a catheter, at least one electrode contact, and a signal processing chip, wherein each electrode contact is attached to the outer wall of the catheter, and each electrode contact is configured to at least one of the following: collect a bioelectric signal of an object, or, deliver electrical stimulation to tissue in the body of the object on the basis of a stimulation pulse signal; and the signal processing chip is arranged in the catheter, and the signal processing chip is electrically connected to the at least one electrode contact.

Description

Electrode lead, stimulator system, and computer-readable storage medium

[0001] This application claims priority to Chinese patent applications filed with the China Patent Office on August 30, 2023, with application numbers 202311105287.X and 202322341916.0. The entire contents of the above applications are incorporated by reference into this application. Technical Field

[0002] The present application relates to the field of medical device technology, for example, to electrode leads, stimulator systems, and computer-readable storage media. Background Art

[0003] Electrode contacts are the carriers of electrical stimulation therapy and bioelectrical signal collection. They are electrically connected to the pulse generator via corresponding cables (electrode leads and extension leads). Generally speaking, the amplitude of bioelectrical signals is on the order of μV, while the amplitude of stimulation pulse signals is on the order of V, a difference of six orders of magnitude. Even with an additional shielding layer inside the cable, bioelectrical signals (analog signals) are highly susceptible to interference from the external environment and the stimulation pulse signals within the cable, which can complicate bioelectrical signal analysis and subsequent closed-loop control.

[0004] Summary of the Invention

[0005] The present application provides an electrode wire, a stimulator system, and a computer-readable storage medium, which integrates a signal processing chip inside the electrode wire to reduce interference from external interference and stimulation pulse signals on bioelectric signals.

[0006] In a first aspect, the present application provides an electrode lead, comprising a catheter, at least one electrode contact, and a signal processing chip:

[0007] Each electrode contact is attached to the outer wall of the catheter, and each electrode contact is configured to at least one of the following: collect bioelectrical signals of the subject, or deliver electrical stimulation to the subject's body tissue according to the stimulation pulse signal;

[0008] The signal processing chip is disposed inside the catheter, and the signal processing chip is electrically connected to the at least one electrode contact.

[0009] In some optional embodiments, the signal processing chip integrates a signal analysis circuit and a signal acquisition circuit, wherein the signal analysis circuit is configured to analyze the stimulation control instructions sent by the pulse generator and convert the stimulation control instructions into the stimulation pulse signal, and the signal acquisition circuit is configured to convert the bioelectric signal collected by the at least one electrode contact into a digital signal to be measured and output it.

[0010] In some optional embodiments, multiple groups of electrode contacts are provided along the length direction of the catheter, and the electrode contacts in each group are evenly distributed along the circumference of the catheter.

[0011] In some optional embodiments, for the electrode contacts in each group, when any one electrode contact delivers electrical stimulation to the subject's in vivo tissue according to the stimulation pulse signal, some or all of the other electrode contacts in the same group collect the subject's bioelectric signals.

[0012] In some optional embodiments, the electrode wire is provided with 2 to 8 groups of electrode contacts.

[0013] In some optional embodiments, the electrode wire is provided with 4 groups of electrode contacts.

[0014] In some optional embodiments, each group includes 1 to 9 electrode contacts.

[0015] In some optional embodiments, each group includes 3 electrode contacts.

[0016] In some optional embodiments, the catheter is made of a rubber tube, the signal processing chip includes at least one bare chip, the signal processing chip is electrically connected to each electrode contact via a metal wire, and at least one bare chip is electrically connected to each other via a metal wire.

[0017] In some optional embodiments, the signal processing chip includes 1 to 10 bare chips.

[0018] In some optional embodiments, the signal processing chip includes three bare chips.

[0019] In some optional embodiments, three bare chips form a triangular prism structure.

[0020] In some optional embodiments, adhesive is filled between the signal processing chip and the inner wall of the catheter to fix the signal processing chip inside the catheter.

[0021] In some optional embodiments, the signal acquisition circuit includes an amplification module, a bandpass filtering module, and an analog-to-digital conversion module connected in sequence:

[0022] The amplification module is configured to amplify the bioelectric signal to obtain a first intermediate signal;

[0023] The bandpass filtering module is configured to perform bandpass filtering on the first intermediate signal to obtain a second intermediate signal;

[0024] The analog-to-digital conversion module is configured to perform analog-to-digital conversion on the second intermediate signal to obtain the digital signal to be tested.

[0025] In some optional embodiments, the subject's in vivo tissue includes the subthalamic nucleus.

[0026] In some optional embodiments, the bioelectric signal includes a local field potential signal.

[0027] In a second aspect, the present application provides a stimulator system, comprising: a pulse generator and any one of the above-mentioned electrode wires, wherein the pulse generator is electrically connected to a signal processing chip in the electrode wire.

[0028] In some optional embodiments, the pulse generator includes a memory and at least one processor, the memory stores a computer program, and the at least one processor is configured to implement the following when executing the computer program:

[0029] receiving the digital signal to be tested output by the signal processing chip;

[0030] A stimulation control instruction is generated according to the digital signal to be tested, and the stimulation control instruction is output to the signal processing chip.

[0031] In some optional embodiments, the at least one processor is configured to further implement, when executing the computer program:

[0032] obtaining disease information of the subject;

[0033] According to the disease information and the digital signal to be tested, setting a first duration and a second duration corresponding to a signal acquisition period;

[0034] wherein, during the first time period, at least one electrode contact transmits the stimulation pulse signal to the subject's internal tissue, and at least one of the remaining electrode contacts collects the subject's bioelectrical signal;

[0035] During the second time period, at least one electrode contact does not transmit the stimulation pulse signal, and at least one of the remaining electrode contacts collects the bioelectrical signal of the subject.

[0036] In a third aspect, the present application provides a computer-readable storage medium storing a computer program, which implements the functions of any of the above-mentioned stimulator systems when executed by at least one processor.

[0037] In a fourth aspect, the present application further provides a computer program product, which includes a computer program, and when the computer program is executed by at least one processor, it implements the functions of any of the above-mentioned stimulator systems. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The present application is described below with reference to the accompanying drawings and implementation methods.

[0039] FIG1 is a schematic structural diagram of an electrode wire provided in an embodiment of the present application.

[0040] FIG2 is a schematic structural diagram of another electrode wire provided in an embodiment of the present application.

[0041] FIG3 is a schematic diagram showing the principle of signal transmission of a stimulator system provided in an embodiment of the present application.

[0042] FIG4 is a structural block diagram of a stimulator system provided in an embodiment of the present application.

[0043] FIG5 is a schematic diagram of the structure of a program product provided in an embodiment of the present application.

[0044] FIG6 is a structural block diagram of a signal processing chip provided in an embodiment of the present application. DETAILED DESCRIPTION

[0045] The technical solutions in this application will be described below in conjunction with the accompanying drawings and specific implementation methods of this application. Under the premise of no conflict, the multiple implementation methods or multiple technical features described below can be arbitrarily combined to form a new implementation method.

[0046] In the embodiments of the present application, "at least one" refers to one or more, and "more" refers to two or more. "And / or" describes the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B can represent: the existence of A alone, the existence of A and B at the same time, and the existence of B alone, where A and B can be singular or plural. The character " / " generally indicates that the objects associated before and after are in an "or" relationship. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single or plural items. For example, at least one of a, b or c can represent: a, b, c, a and b, a and c, b and c, a and b and c, where a, b and c can be single or multiple. It is worth noting that "at least one" can also be interpreted as "one or more items".

[0047] In the examples of this application, words such as "exemplary" or "for example" are used to indicate examples, illustrations, or descriptions. Any embodiment or design described as "exemplary" or "for example" in the examples of this application should not be interpreted as being more preferred or advantageous than other embodiments or designs. The use of words such as "exemplary" or "for example" is intended to present the relevant concepts in a concrete way.

[0048] Below, we first briefly describe one of the application fields of the present application (i.e., implantable neurostimulator).

[0049] Implantable medical systems include implantable neurostimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead adapter systems. Examples of implantable neurostimulation systems include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0050] An implantable neurostimulation system includes an implantable target, such as a stimulator (i.e., an implantable neurostimulator, a type of neurostimulation device) within a patient's body, and a programmable device located outside the patient's body. In other words, the stimulator is an implant, or in other words, the implant includes the stimulator. Related neuromodulation technologies primarily involve implanting electrodes (e.g., in the form of electrode wires) at specific locations (i.e., target sites) within a living organism's tissues through stereotactic surgery. These electrodes then emit discharge pulses to the target sites, regulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and alleviating pain. The stimulator may include an implantable pulse generator (IPG), extension wires, and electrode wires. The IPG is located within the patient's body and, in response to programmable instructions sent by the programmable device, relies on sealed batteries and circuits to provide controllable electrical stimulation energy to the tissues within the body. The IPG delivers one or more controllable, specific electrical stimulations to specific areas of the body's tissues via the extension wires and electrode wires. The extension wires, used in conjunction with the IPG, serve as a transmission medium for the electrical stimulation signals, transmitting the electrical stimulation signals generated by the IPG to the electrode wires. The electrode wire delivers electrical stimulation to a specific area of ​​tissue in the body through a plurality of 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 provided on the electrode wire, and the electrode contacts can be arranged uniformly or non-uniformly in the circumference of the electrode wire. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumference of the electrode wire. The electrode contacts may include stimulation electrode contacts and / or collection electrode contacts. The electrode contacts may, for example, be in the shape of a sheet, a ring, a point, or the like.

[0051] In other embodiments, the stimulator includes only a pulse generator and electrode leads, wherein the pulse generator is embedded in the patient's skull and the electrode leads are implanted in the patient's skull. In this case, the pulse generator and the electrode leads are directly connected without the need for extension leads.

[0052] As an example, a deep brain stimulation (DBS) system includes an IPG, an extension lead, and an electrode lead, wherein the IPG is connected to the electrode lead via the extension lead. The IPG is implanted in the patient's body, for example, in the patient's chest or other body parts.

[0053] As another example, DBS includes an IPG and an electrode lead, with the IPG directly connected to the electrode lead. The IPG is implanted in the patient's head, for example, by making a groove in the patient's skull and then installing the IPG in the groove. In this case, the IPG may not protrude from the outer surface of the skull, or may partially protrude from the outer surface of the skull.

[0054] In some embodiments, the stimulated body tissue can be the patient's brain tissue, and the stimulated site can be a specific site of the brain tissue. When the patient's disease type is different, the stimulated site is generally different, and the number of stimulation contacts (electrode contacts) (single source or multiple sources) used, the use of one or more (single channel or multiple channels) specific electrical stimulation signals, and the stimulation parameter data are also different. The embodiments of the present application do not limit the applicable disease types, and the applicable disease types can be deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and disease types applicable to functional electrical stimulation. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., Major Depressive Disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, hypoactive depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism or other neurological or psychiatric diseases and injuries.

[0055] In an embodiment of the present application, when a programmable connection is established between the programmable device and the stimulator, the programmable device can be used to adjust the stimulation parameters of the stimulator (or the stimulation parameters of the pulse generator, different stimulation parameters correspond to different electrical stimulation signals), or the stimulator can be used to sense the patient's electrophysiological activities to collect bioelectric signals, and the collected bioelectric signals can be used to further adjust the stimulation parameters of the stimulator.

[0056] The stimulation parameters of the electrical stimulation signal may include frequency (for example, the number of electrical stimulation pulse signals per unit time 1s, in Hz), pulse width (the duration of each pulse, in μs), and amplitude (generally expressed in voltage, that is, the intensity of each pulse, in 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 cyclic stimulation mode), doctor control upper and lower limits (the range that the doctor can adjust) and patient control upper and lower limits (the range that the patient can adjust independently) One or more. In specific applications, multiple stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

[0057] The programmable device can be a user programmer, where the user can be a doctor or a patient, i.e., a doctor programmer or a patient programmer. A doctor programmer can be, for example, a tablet computer, laptop computer, desktop computer, mobile phone, or other intelligent terminal device equipped with programming software. A patient programmer can be, for example, a tablet computer, laptop computer, desktop computer, mobile phone, or other intelligent terminal device equipped with programming software. A patient programmer can also be other electronic devices with programming capabilities (e.g., a charger or data acquisition device with programming capabilities).

[0058] This application does not restrict the data interaction between the doctor programmer and the stimulator. When the doctor is remotely programming, the doctor programmer can exchange data with the stimulator through the server and the patient programmer. When the doctor is offline and programming with the patient face to face, the doctor programmer can exchange data with the stimulator through the patient programmer, and the doctor programmer can also directly interact with the stimulator.

[0059] The patient programmer may include a host computer that communicates with the server and a slave computer that communicates with the stimulator, and the host computer and the slave computer are communicably connected. The doctor programmer may exchange data with the server via the third-generation mobile communication technology (3G) / 4G / 5G network, the server may exchange data with the host computer via the 3G / 4G / 5G network, the host computer may exchange data with the slave computer via the Bluetooth protocol / Wireless Fidelity (WIFI) protocol / Universal Serial Bus (USB) protocol, the slave computer may exchange data with the stimulator via the 401MHz-406MHz operating frequency band / 2.4GHz-2.48GHz operating frequency band, and the doctor programmer may directly exchange data with the stimulator via the 401MHz-406MHz operating frequency band / 2.4GHz-2.48GHz operating frequency band.

[0060] In order to achieve real-time closed-loop stimulation, the electrode contacts need to collect bioelectric signals in addition to providing electrical stimulation.

[0061] The present application provides an electrode wire, a stimulator system, and a computer-readable storage medium, which reduces the interference of external interference and stimulation pulse signals on bioelectric signals by integrating a signal processing chip inside the electrode wire.

[0062] Electrode lead embodiment

[0063] 1 and 2 , FIG1 is a schematic structural diagram of an electrode conductor provided in an embodiment of the present application, and FIG2 is a schematic structural diagram of another electrode conductor provided in an embodiment of the present application.

[0064] The electrode lead comprises a catheter, at least one electrode contact and a signal processing chip:

[0065] Each electrode contact is attached to the outer wall of the catheter, and each electrode contact is configured to collect a bioelectrical signal of the patient and / or deliver electrical stimulation to the patient's body tissue according to a stimulation pulse signal;

[0066] The signal processing chip is disposed inside the catheter, and the signal processing chip is electrically connected to the at least one electrode contact.

[0067] In some embodiments, as shown in Figure 6, the signal processing chip integrates a signal analysis circuit and a signal acquisition circuit, wherein the signal analysis circuit is configured to analyze the stimulation control instructions sent by the pulse generator and convert them into the stimulation pulse signal, and the signal acquisition circuit is configured to convert the bioelectric signals collected by the electrode contacts into digital signals to be measured and output them.

[0068] The embodiments of the present application do not limit the types of bioelectric signals, and the bioelectric signals may include neuronal signals and / or local field potential signals.

[0069] Neuronal signals are electrical signals generated by neuronal cells and are used to transmit information between neurons. Neuronal signals usually exist in the form of pulses, which are called action potentials. The collection and analysis of neuronal signals can provide information about neuronal activity, thereby helping to understand the functions and abnormalities of the nervous system. Local field potential (LFP) signals refer to changes in electric potential generated by the electrical activity of surrounding neurons. The collection of local field potential signals can provide information about neural network activity and the behavior of neuronal groups. By analyzing local field potential signals, we can understand the synchronization, regulatory mechanisms, and electrical activities related to specific functions of neuronal groups. By collecting and analyzing neuronal signals and / or local field potential signals, we can obtain important information about the function and disease state of the nervous system, which is helpful for the diagnosis and treatment of neurological diseases and provides personalized closed-loop deep brain stimulation therapy.

[0070] This application does not limit the types of patients to which the electrode wires are applicable. Applicable patient types include, for example, Parkinson's patients, obsessive-compulsive disorder patients, etc. The following takes Parkinson's disease as an example for easier understanding. Parkinson's disease is a neurodegenerative disease whose main symptoms are movement disorders, such as tremor, bradykinesia, and muscle rigidity; the bioelectric signal used to obtain is, for example, a local field potential (LFP) signal. Parkinson's disease is usually manifested as the power spectral density of the LFP signal β band (13-35Hz) being higher or lower than a preset range, that is, the power spectral density is abnormal. In other words, judging whether the power spectral density is abnormal can be used as an important basis for closed-loop feedback for Parkinson's patients, and can be used to adjust the parameters of the patient's electrical stimulation to improve the symptoms of Parkinson's patients.

[0071] As an example, an electrode lead includes a catheter, at least one electrode contact, and a signal processing chip. The catheter is a soft and insulating tubular structure configured to accommodate the electrode contacts and the signal processing chip. It can be made of an elastic material such as rubber to adapt to the curves and shapes of biological tissues. A plurality of electrode contacts are attached to the outer wall of the catheter. For example, 4×3 electrode contacts are provided. These electrode contacts are attached to the outer wall of the catheter and are configured to collect bioelectric signals or deliver electrical stimulation according to stimulation control instructions. Each electrode contact can contact a different brain area or neuron. The signal processing chip is located inside the catheter and is configured to process the collected signals and perform stimulation control. The signal processing chip integrates a signal analysis circuit and a signal acquisition circuit. The signal analysis circuit is configured to parse the stimulation control instructions from the pulse generator. For example, when the stimulator requires electrical stimulation of a certain intensity at a specific time and location, the signal analysis circuit can interpret these instructions as parameters of the stimulation pulse signal. The signal acquisition circuit is configured to convert the bioelectric signals from the electrode contacts into digital signals. Assuming that the electrode contacts record the electrical activity of the brain area, the signal acquisition circuit will amplify and filter these weak bioelectric signals and convert them into digital signals to be tested for further processing and analysis.

[0072] Thus, by integrating a signal processing chip inside the electrode wire, the interference of external interference and stimulation pulse signals on bioelectric signals is reduced. The traditional approach is to integrate the signal analysis circuit and the signal acquisition circuit inside the pulse generator, and transmit the bioelectric signal (analog signal) and the stimulation pulse signal simultaneously through the cable. However, the present application transplants the signal analysis circuit and the signal acquisition circuit inside the pulse generator into the electrode wire in the form of a dedicated integrated circuit (Application Specific Integrated Circuit, ASIC), and uses the signal processing chip to convert the bioelectric signal (analog signal) originally transmitted in the cable into a digital signal. Compared with the analog signal, the digital signal has a stronger anti-interference ability, and by placing the signal processing chip inside the wire, the bioelectric signal can be processed at a position closer to the electrode contact, thereby reducing the impact of external interference on the bioelectric signal, and further improving the signal's anti-interference ability. In summary, the electrode wire provided by the present application helps to improve the collection effect and quality of bioelectric signals and reduce the problems of external interference and signal cross interference.

[0073] The electrode wire provided in this application can replace the analog small signal transmitted in the cable with a digital signal, thereby alleviating the influence of the cable transmission on the external environment (such as electrocardiogram signals, electrooculogram signals, electromyography signals, strong external magnetic fields, strong external electric fields, etc.) and internal strong electrical stimulation signals, and reducing the impact of LFP signal analysis deviation on IPG closed-loop control.

[0074] In some embodiments, the signal acquisition circuit includes an amplification module, a bandpass filtering module, and an analog-to-digital conversion module;

[0075] The amplification module is configured to amplify the bioelectric signal to obtain a first intermediate signal;

[0076] The bandpass filtering module is configured to perform bandpass filtering on the first intermediate signal to obtain a second intermediate signal;

[0077] The analog-to-digital conversion module is configured to perform analog-to-digital conversion on the second intermediate signal to obtain the digital signal to be tested.

[0078] Therefore, the signal acquisition circuit is designed to include an amplification module, a bandpass filtering module, and an analog-to-digital conversion module, so that the process of converting the bioelectric signal into the digital signal to be measured covers the steps of amplification, filtering, and analog-to-digital conversion. The amplification module can enhance the amplitude of the bioelectric signal, making it easier to process and analyze. The bandpass filtering module can filter out interference and noise from the outside world, making the signal more reliable. The filtering can also highlight the signal within a specific frequency range, which is helpful for analyzing specific physiological phenomena. The analog-to-digital conversion module converts the continuous analog signal into a digital signal, so that the signal can be processed, stored, and analyzed on a digital device. This digital signal is easier to process and can be analyzed in a computer system. In summary, converting the bioelectric signal into the digital signal to be measured can reduce the error of the analog signal during transmission and processing, thereby improving the accuracy and reliability of the signal.

[0079] In some embodiments, multiple groups of electrode contacts are provided along the length direction of the catheter, and each group of electrode contacts is evenly distributed along the circumference of the catheter.

[0080] In some embodiments, for each group of electrode contacts, any one electrode contact delivers electrical stimulation to the patient's internal tissue according to the stimulation pulse signal while using part or all of the other electrode contacts in the same group to collect the patient's bioelectrical signals.

[0081] In some embodiments, the electrode wire is provided with 2 to 8 groups of electrode contacts, and each group of electrode contacts includes 1 to 9 electrode contacts.

[0082] The embodiments of the present application do not limit the number of electrode contacts grouped together. The number of groups can be, for example, 3, 4, 5, or 8. The number of groups can be set based on the size of the electrode wire and the tissue in the body. Accordingly, the number of electrode contacts in each group is also not limited. The number of electrode contacts in each group can be, for example, 2, 3, 4, 6, or 9.

[0083] Thus, on the one hand, multiple electrode contacts can be divided into multiple groups along the length of the catheter. By setting up segmented electrode contacts, each group of electrode contacts can achieve separate directional electrical stimulation, so that the electrical stimulation generated can be targeted at a specific part / direction, thereby reducing overdose treatment; on the other hand, multi-channel bioelectric signal collection and electrical stimulation can be performed, and different combinations of electrode contacts can be used for electrical stimulation and bioelectric signal collection respectively, which helps to isolate electrical stimulation signals and bioelectric signals and reduce cross-interference. By evenly distributing multiple electrode contacts around the circumference of the catheter, better spatial resolution can be obtained, which helps to locate and analyze the signal source of the bioelectric signal; on the other hand, while one electrode contact delivers electrical stimulation, other electrode contacts are used to collect bioelectric signals, achieving the effect of stimulating and collecting at the same time. The bioelectric signals collected in this way can better reflect the patient's true EEG condition during electrical stimulation treatment.

[0084] In some embodiments, the electrode wire is provided with 4 groups of electrode contacts, and each group of electrode contacts includes 3 electrode contacts.

[0085] In the embodiment of the present application, a total of 4×3, i.e., 12, electrode contacts are provided on the electrode wire, wherein, in each group of electrode contacts, one electrode contact is used for electrical stimulation, and the other two electrode contacts are used for LFP signal acquisition. The first group of electrode contacts are sequentially recorded as 1a, 1b, and 1c, the second group of electrode contacts are sequentially recorded as 2a, 2b, and 2c, the third group of electrode contacts are sequentially recorded as 3a, 3b, and 3c, and the fourth group of electrode contacts are sequentially recorded as 4a, 4b, and 4c. 1a, 2a, 3a, and 4a are electrode contacts in the same column along the axial direction of the slice-type electrode, 1b, 2b, 3b, and 4b are electrode contacts in the same column along the axial direction of the slice-type electrode, and 1c, 2c, 3c, and 4c are electrode contacts in the same column along the axial direction of the slice-type electrode.

[0086] Assuming that all 12 electrode contacts are located in the nucleus, cyclic stimulation is performed with fixed stimulation parameters (e.g., 4V, 100us, 150Hz), i.e., stimulation 1a and acquisition of 1b and 1c, stimulation 1b and acquisition of 1a and 1c, stimulation 1c and acquisition of 1a and 1b, stimulation 2a and acquisition of 2b and 2c, stimulation 2b and acquisition of 2a and 2c, stimulation 2c and acquisition of 2a and 2b, stimulation 3a and acquisition of 3b and 3c, stimulation 3b and acquisition of 3a and 3c, stimulation 3c and acquisition of 3a and 3b, stimulation 4a and acquisition of 4b and 4c, stimulation 4b and acquisition of 4a and 4c, and stimulation 4c and acquisition of 4a and 4b, totaling 12 situations. In each situation, the state of no stimulation and acquisition only and the state of stimulation and acquisition are each continued for a preset duration. The preset duration can be, for example, 1 minute, 2 minutes, or 4 minutes.

[0087] The bioelectric signal in the state of no stimulation and only collection is recorded as the first electrical signal, and the bioelectric signal in the state of stimulating and collecting is recorded as the second electrical signal. The bioelectric signal collected by the electrode contacts includes the first electrical signal and the second electrical signal.

[0088] As a result, each set of electrode contacts provides three electrode contacts, so a total of 12 electrode contacts are available, which enables the electrode wire to simultaneously collect bioelectric signals from more channels, thereby providing richer and more comprehensive signal information. The three electrode contacts within each set of electrode contacts can collect signals at different angles and depths, which is very helpful for locating the signal source, analyzing signal changes, and studying the electrical activity characteristics of tissues in the body. By combining within each set of electrode contacts, a variety of stimulation modes can be achieved, such as selectively stimulating different areas, adjusting the stimulation intensity, etc., which is very valuable for some specific electrical stimulation treatment applications.

[0089] In some embodiments, the catheter is a rubber tube, the signal processing chip includes at least one bare chip, the signal processing chip is electrically connected to each electrode contact via a metal wire, and each bare chip is electrically connected to each other via a metal wire.

[0090] In some embodiments, the signal processing chip includes 1 to 10 bare chips.

[0091] The embodiment of the present application does not limit the number of bare chips. The number of bare chips can be, for example, 1, 2, 3, 4, 7 or 10.

[0092] When three bare chips are used, the bare chips can be assembled into a triangular prism structure, and when four bare chips are used, the bare chips can be assembled into a rectangular parallelepiped structure.

[0093] Bare chips, also known as die-only chips, refer to exposed chips—chips without packaging or encapsulation materials. Compared to traditional packaged chips, die-only chips have a smaller size and higher integration density. They take up less space in electronic devices and offer faster data transmission speeds and lower energy consumption. The small size of bare chips allows for shorter signal transmission paths, reducing the possibility of signal loss. In addition, since there is no packaging material (such as plastic or ceramic), bare chips have better high-frequency response and higher reliability.

[0094] In the embodiments of the present application, the metal wire can be a gold wire. The metal wire needs to connect the electrode contacts on the outer wall of the catheter and the bare chip inside the catheter. Therefore, the metal wire will directly contact the patient's internal tissue (nucleus). Gold wire has good electrical conductivity, which provides a guarantee for signal transmission, allowing the bare chip to accurately read and transmit signals. In addition, gold has strong antioxidant properties, which helps maintain the long-term stability of the electrode wire. In addition, gold has good biocompatibility, which reduces the body's rejection reaction to the electrode wire, avoids the electrode wire triggering an immune response or inflammatory response in the patient after implantation in the brain, and improves safety and ease of use.

[0095] Therefore, the rubber tube as a catheter material has a certain flexibility and can adapt to the shape of different organs and tissues. This flexibility helps improve the patient's comfort and implant experience. Using metal wires to connect the signal processing chip and the electrode contacts can reduce signal transmission loss and interference. The metal wires can effectively transmit bioelectric signals and stimulation pulse signals, helping to maintain signal integrity. Each electrode contact is electrically connected to the signal processing chip, and the bare chips are also connected to each other through metal wires. The modular design of this chip makes subsequent maintenance, upgrades, and replacements more convenient.

[0096] In some embodiments, the signal processing chip includes three bare chips, and the three bare chips form a triangular prism structure;

[0097] In some embodiments, adhesive is filled between the signal processing chip and the inner wall of the catheter to fix the signal processing chip inside the catheter.

[0098] The embodiment of the present application does not limit the adhesive, and the adhesive can be glue.

[0099] As a result, the triangular prism structure can effectively utilize the internal space of the catheter, making the signal processing chip more stable within the limited space. This compact structure helps to simplify the layout of the electrode wires. Using an adhesive to fix the signal processing chip inside the catheter can prevent the signal processing chip from loosening or shifting during use, thereby improving the stability and reliability of the electrode wires. On the one hand, directly fixing the signal processing chip inside the catheter can optimize the signal transmission path, reduce signal transmission loss and interference, and thus improve signal quality. On the other hand, the signal processing chip is completely encapsulated inside the catheter, which can reduce the impact of the external environment on the signal processing chip, further improving the stability and accuracy of the signal.

[0100] In some embodiments, the patient's in vivo tissue includes the subthalamic nucleus, and the bioelectric signal includes a local field potential signal.

[0101] Therefore, the subthalamic nucleus is an important area in the brain, involved in a variety of neural functions, such as motor control and emotional regulation. By collecting local field potential signals, detailed information about the activity of the subthalamic nucleus can be obtained, which is helpful for studying the function and regulatory mechanism of the subthalamic nucleus. In clinical applications, the treatment of specific patients (such as Parkinson's patients) may need to be adjusted according to their subthalamic nucleus activity. The collection of local field potential signals can provide important physiological information for personalized treatment. Through stimulation pulse signals, targeted electrical stimulation can be delivered to the subthalamic nucleus, which is of great help in the neuromodulatory treatment of Parkinson's patients.

[0102] In a specific application scenario, the present application provides an electrode lead, which includes a catheter, at least one electrode contact, and a signal processing chip:

[0103] Each electrode contact is attached to the outer wall of the catheter, and each electrode contact is configured to collect bioelectric signals of the patient and / or deliver electrical stimulation to the patient's internal tissue according to the stimulation pulse signal, wherein the patient's internal tissue includes the subthalamic nucleus, and the bioelectric signals include local field potential signals;

[0104] The signal processing chip is disposed inside the catheter and is electrically connected to the at least one electrode contact. The signal processing chip integrates a signal analysis circuit and a signal acquisition circuit, wherein the signal analysis circuit is configured to analyze the stimulation control instructions sent by the pulse generator and convert them into the stimulation pulse signal, and the signal acquisition circuit is configured to convert the bioelectrical signals collected by the electrode contacts into digital signals to be measured and output them;

[0105] Four groups of electrode contacts are provided along the length direction of the catheter, each group of electrode contacts is evenly distributed along the circumference of the catheter, and each group of electrode contacts includes three electrode contacts;

[0106] For each group of electrode contacts, any one electrode contact, while delivering electrical stimulation to the patient's internal tissue according to the stimulation pulse signal, utilizes part or all of the other electrode contacts in the same group to collect the patient's bioelectrical signals;

[0107] The catheter is made of a rubber tube, and the signal processing chip includes three bare chips, which form a triangular prism structure; the signal processing chip is electrically connected to each electrode contact via a metal wire, and the three bare chips are electrically connected to each other via the metal wires;

[0108] An adhesive is filled between the signal processing chip and the inner wall of the conduit so as to fix the signal processing chip inside the conduit;

[0109] The signal acquisition circuit includes an amplification module, a bandpass filtering module, and an analog-to-digital conversion module. The process of converting the bioelectric signal into a digital signal to be measured includes:

[0110] amplifying the bioelectric signal using the amplification module to obtain a first intermediate signal;

[0111] performing bandpass filtering on the first intermediate signal using the bandpass filtering module to obtain a second intermediate signal;

[0112] The analog-to-digital conversion module is used to perform analog-to-digital conversion on the second intermediate signal to obtain the digital signal to be tested.

[0113] In one embodiment, the design of the catheter can be designed to include softer and more comfortable materials to better adapt to the patient's physiological structure, which can improve the comfort of wearing while reducing interference with biological tissues. For signal processing chips, the signal analysis circuit and signal acquisition circuit can be optimized to achieve higher signal enhancement and noise reduction capabilities, improve signal quality and accuracy, such as adding multiple stimulation modes to enable the stimulator to operate at different frequencies, amplitudes, and durations, which can better meet the needs of different diseases or treatment goals. Introducing a real-time feedback mechanism to convert the collected bioelectric signals into visual or auditory feedback can help patients or doctors better understand the patient's Physiological state and stimulation effect; optimize the processor of the pulse generator so that it can adaptively adjust the stimulation parameters according to the real-time collected bioelectric signals to provide more precise stimulation; introduce remote monitoring and control functions to enable doctors or researchers to remotely adjust stimulation parameters, observe signal quality and perform real-time data analysis; consider using wireless communication technologies, such as Bluetooth or Wi-Fi, to achieve wireless connection between the stimulator / stimulator system and external devices to reduce the constraints of wires; optimize the selection of wire materials and shell materials to ensure long-term stability and biocompatibility; ensure that the signal acquisition, transmission and storage processes have sufficient data security measures to protect patient privacy.

[0114] Stimulator System Embodiments

[0115] See FIG3 , which is a schematic diagram showing the principle of signal transmission of a stimulator system provided in an embodiment of the present application.

[0116] An embodiment of the present application further provides a stimulator system, comprising: a pulse generator and any one of the above-mentioned electrode wires, wherein the pulse generator is electrically connected to a signal processing chip in the electrode wire.

[0117] In some embodiments, the pulse generator includes a memory and at least one processor, the memory storing a computer program, and the at least one processor being configured to implement the following steps when executing the computer program:

[0118] receiving the digital signal to be tested output by the signal processing chip;

[0119] A corresponding stimulation control instruction is generated according to the digital signal to be tested, and the stimulation control instruction is output to the signal processing chip.

[0120] In some embodiments, the stimulator system further includes an extension wire, through which the pulse generator can be electrically connected to the signal processing chip (as shown in FIG1 ), or the pulse generator can be directly electrically connected to the signal processing chip (as shown in FIG2 ).

[0121] In some embodiments, the at least one processor is configured to further implement the following steps when executing the computer program:

[0122] obtaining disease information of the patient;

[0123] According to the disease information and the digital signal to be tested, setting a first duration and a second duration corresponding to a signal acquisition period;

[0124] wherein, during the first time period, at least one electrode contact is used to deliver electrical stimulation to the patient's internal tissue while collecting the patient's bioelectrical signals;

[0125] During the second time period, bioelectrical signals of the patient are collected using at least one electrode contact while no electrical stimulation is delivered.

[0126] For example, during the first time period, at least one electrode contact transmits the stimulation pulse signal to the subject's internal tissue, and at least one of the remaining electrode contacts collects the subject's bioelectrical signal;

[0127] During the second duration, at least one electrode contact does not emit the stimulation pulse signal, and at least one of the remaining electrode contacts collects the subject's bioelectrical signal. In one embodiment, a pre-trained deep learning model can be used to set the first and second durations corresponding to the signal collection cycle based on the disease information and the digital signal to be measured.

[0128] In an embodiment of the present application, the first duration and the second duration together constitute a signal acquisition cycle. The first duration and the second duration may be equal or unequal. The first duration may be, for example, 1 minute, 2 minutes or 4 minutes, and the second duration may be, for example, 1 minute, 2 minutes or 4 minutes.

[0129] As an example, the first duration and the second duration are both 1 minute.

[0130] Assume that all 12 electrode contacts are located in the nucleus. The first group of electrode contacts is 1a, 1b, and 1c. Within the first minute, 1a is stimulated and 1b and 1c are collected. Within the second minute, 1a is de-stimulated and 1b and 1c are collected. Then, within the third minute, 1b is stimulated and 1a and 1c are collected. Within the fourth minute, 1b is de-stimulated and 1a and 1c are collected. Then, within the fifth minute, 1c is stimulated and 1a and 1b are collected. Within the sixth minute, 1c is de-stimulated and 1a and 1b are collected. This process continues in this manner until all electrode contact groups have implemented the dual acquisition mode of both stimulation and acquisition within the group and acquisition only without stimulation.

[0131] Therefore, based on the patient's disease information and the digital signal to be measured, the first and second durations of the signal acquisition cycle are set. During the first duration, the stimulator system collects bioelectric signals through the electrode contacts while delivering electrical stimulation (stimulating while collecting). During the second duration, the stimulator system only collects bioelectric signals without performing electrical stimulation (collecting without stimulating). In this way, the patient's bioelectric signals when receiving electrical stimulation and the patient's bioelectric signals when not receiving electrical stimulation can be obtained. The two bioelectric signals are analyzed and compared comprehensively to provide an accurate basis for closed-loop stimulation.

[0132] In a specific application scenario, the present application provides a stimulator system, comprising: a pulse generator and an electrode wire, wherein the pulse generator is electrically connected to a signal processing chip in the electrode wire via the extension wire;

[0133] The pulse generator includes a memory and at least one processor, wherein the memory stores a computer program, and the at least one processor is configured to implement the following steps when executing the computer program:

[0134] receiving the digital signal to be tested output by the signal processing chip;

[0135] generating corresponding stimulation control instructions according to the digital signal to be tested, and outputting the stimulation control instructions to the signal processing chip;

[0136] obtaining disease information of the patient;

[0137] According to the disease information and the digital signal to be tested, setting a first duration and a second duration corresponding to a signal acquisition period;

[0138] wherein, during the first time period, at least one electrode contact is used to deliver electrical stimulation to the patient's internal tissue while collecting the patient's bioelectrical signals;

[0139] During the second time period, bioelectrical signals of the patient are collected using at least one electrode contact while no electrical stimulation is delivered.

[0140] In one embodiment, multiple sensors are added to the electrode wires to capture more bioelectric signals, such as electrocardiogram (ECG) signals, electrooculogram (EOG) signals, and electromyography (EMG) signals, which can provide more comprehensive information for treatment. An adaptive energy management system is integrated into the stimulator system to intelligently distribute energy based on real-time energy needs, thereby improving battery life or wireless charging efficiency. Appropriate privacy protection and security measures are ensured for the patient's biological data, while allowing patients and doctors to control data sharing and storage. Remote monitoring and data transmission of the stimulator system are achieved through a cloud platform, so that doctors can remotely adjust stimulation parameters and monitor the patient's status in real time. Customized treatment plans are developed for different types of diseases and individuals to ensure that the stimulator system can achieve the best results in a variety of situations. Close cooperation is carried out with neuroscientists, clinicians, and engineers to ensure that the design and application of the stimulator system have practical feasibility and advantages in science, medicine, and engineering. Long-term stability testing is conducted to ensure that the stimulator system remains stable and reliable during long-term use.

[0141] See FIG4 , which is a structural block diagram of a stimulator system provided in an embodiment of the present application.

[0142] The stimulator system may include, for example, at least one memory 11 , at least one processor 12 , and a bus 13 connecting different platform systems.

[0143] The memory 11 may include a readable medium in the form of a volatile memory, such as a random access memory (RAM) 111 and / or a cache memory 112 , and may also include a read-only memory (ROM) 113 .

[0144] The memory 11 also stores a computer program, which can be executed by the processor 12 so that the processor 12 implements the above steps.

[0145] The memory 11 may also include a utility 114 having at least one program module 115, such program module 115 including but not limited to: an operating system, one or more application programs, other program modules and program data, each of which or some combination may include an implementation of a network environment.

[0146] Accordingly, the processor 12 may execute the aforementioned computer program and the utility 114 .

[0147] The processor 12 may be implemented as one or more application specific integrated circuits (ASICs), digital signal processors (DSPs), programmable logic devices (PLDs), complex programmable logic devices (CPLDs), field programmable gate arrays (FPGAs), or other electronic components.

[0148] The bus 13 may represent one or more of several types of bus structures, including a memory bus or memory controller, a peripheral bus, an accelerated graphics port, a processor, or a local bus using any of a variety of bus architectures.

[0149] The stimulator system can also communicate with one or more external devices such as keyboards, pointing devices, Bluetooth devices, etc., and can also communicate with one or more devices that can interact with the stimulator system, and / or communicate with any device that enables the stimulator system to communicate with one or more other computing devices (such as routers, modems, etc.). Such communication can be carried out through input and output interfaces 14. In addition, the stimulator system can also communicate with one or more networks (such as local area networks (LANs), wide area networks (WANs), and / or public networks, such as the Internet) through network adapters 15. The network adapter 15 can communicate with other modules of the stimulator system through bus 13. Although not shown in the figure, in actual applications, other hardware and / or software modules can be used in conjunction with the stimulator system, including but not limited to: microcode, device drivers, redundant processors, external disk drive arrays, disk arrays (RAID) systems, tape drives, and data backup storage platforms.

[0150] Computer readable storage medium embodiments

[0151] The embodiment of the present application also provides a computer-readable storage medium, the specific embodiment of which is consistent with the technical effects achieved by the above embodiment, and some contents will not be repeated here.

[0152] The computer-readable storage medium stores a computer program, and when the computer program is executed by at least one processor, the computer program implements the above steps or implements any one of the above functions of the stimulator.

[0153] The computer readable medium can be a computer readable signal medium or a computer readable storage medium. In an embodiment of the present application, the computer readable storage medium can be any tangible medium containing or storing a program, which can be used by an instruction execution system, device or device or used in combination with it. The computer readable storage medium can be, for example, but not limited to, a system, device or device of electricity, magnetism, light, electromagnetic, infrared, or semiconductor, or any combination thereof. The computer readable storage medium can (non-exhaustive list) include: an electrical connection with one or more wires, a portable disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM) or a flash memory, an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination thereof.

[0154] A computer-readable storage medium may include a data signal propagated in baseband or as part of a carrier wave, which carries a readable program code. This propagated data signal may take a variety of forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. A computer-readable storage medium may also be any computer-readable medium that can send, propagate, or transmit a program for use by or in conjunction with an instruction execution system, apparatus, or device. The program code contained on the computer-readable storage medium may be transmitted using any appropriate medium, including but not limited to wireless, wired, optical cable, radio frequency (RF), etc., or any suitable combination of the above. The program code for performing the operations of this application may be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, C++, etc., as well as conventional procedural programming languages ​​such as C or similar programming languages. The program code may be executed entirely on the user computing device, partially on the user device, as a separate software package, partially on the user computing device and partially on a remote computing device, or entirely on a remote computing device or server. Where a remote computing device is involved, the remote computing device may be connected to the user computing device through any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computing device (e.g., through the Internet using an Internet service provider).

[0155] Computer Program Product Embodiments

[0156] The embodiments of the present application also provide a computer program product, the specific embodiments of which are consistent with the technical effects achieved by the above embodiments, and some contents will not be repeated here.

[0157] The present application provides a computer program product, which includes a computer program. When the computer program is executed by at least one processor, it implements the above steps or any one of the above functions of the stimulator.

[0158] See FIG5 , which is a schematic diagram of the structure of a computer program product provided in an embodiment of the present application.

[0159] The computer program product is configured to implement the steps of any of the above methods or to implement the functions of any of the above stimulators. The computer program product can be a portable compact disc read-only memory (CD-ROM) and include program code, and can be run on a terminal device, such as a personal computer. However, the computer program product of the present application is not limited thereto, and the computer program product can be any combination of one or more computer-readable media.

Claims

1. An electrode lead, comprising a catheter, at least one electrode contact and a signal processing chip: Each electrode contact is attached to the outer wall of the catheter, and each electrode contact is configured to at least one of the following: collect bioelectric signals of the subject, or, deliver electrical stimulation to the subject's in vivo tissue according to a stimulation pulse signal; The signal processing chip is disposed inside the catheter, and the signal processing chip is electrically connected to the at least one electrode contact.

2. The electrode lead according to claim 1, wherein: The signal processing chip integrates a signal analysis circuit and a signal acquisition circuit, wherein the signal analysis circuit is configured to analyze the stimulation control instructions sent by the pulse generator and convert the stimulation control instructions into the stimulation pulse signal, and the signal acquisition circuit is configured to convert the bioelectric signal collected by the at least one electrode contact into a digital signal to be measured and output it.

3. The electrode lead according to claim 1, wherein: A plurality of groups of electrode contacts are arranged along the length direction of the catheter, and the electrode contacts in each group are evenly distributed along the circumference of the catheter.

4. The electrode lead according to claim 3, wherein: For the electrode contacts in each group, when any one electrode contact delivers electrical stimulation to the subject's in vivo tissue according to the stimulation pulse signal, part or all of the other electrode contacts in the same group collect the subject's bioelectric signals.

5. The electrode lead according to claim 3, wherein: The electrode wire is provided with 2 to 8 groups of electrode contacts.

6. The electrode lead according to claim 5, wherein: The electrode wire is provided with 4 groups of electrode contacts.

7. The electrode lead according to claim 3, wherein: Each group includes 1 to 9 electrode contacts.

8. The electrode lead according to claim 7, wherein: Each set includes 3 electrode contacts.

9. The electrode lead according to claim 1 or 2, wherein: The catheter is a rubber tube, the signal processing chip includes at least one bare chip, the signal processing chip is electrically connected to each electrode contact through a metal wire, and at least one bare chip is electrically connected to each other through the metal wire.

10. The electrode lead according to claim 9, wherein: The signal processing chip includes 1 to 10 bare chips.

11. The electrode lead according to claim 10, wherein: The signal processing chip includes three bare chips.

12. The electrode lead according to claim 11, wherein: The three bare chips form a triangular prism structure.

13. The electrode lead according to claim 9, wherein: Adhesive is filled between the signal processing chip and the inner wall of the conduit so that the signal processing chip is fixed inside the conduit.

14. The electrode lead according to claim 2, wherein: The signal acquisition circuit comprises an amplification module, a bandpass filtering module and an analog-to-digital conversion module connected in sequence; The amplification module is configured to amplify the bioelectric signal to obtain a first intermediate signal; The bandpass filtering module is configured to perform bandpass filtering on the first intermediate signal to obtain a second intermediate signal; The analog-to-digital conversion module is configured to perform analog-to-digital conversion processing on the second intermediate signal to obtain the digital signal to be tested.

15. The electrode lead according to claim 1 or 2, wherein: The in vivo tissue of the subject includes the subthalamic nucleus.

16. The electrode lead according to any one of claims 1 or 2, wherein: The bioelectric signal includes a local field potential signal.

17. A stimulator system comprising: A pulse generator and an electrode wire as described in any one of claims 1 to 16, wherein the pulse generator is electrically connected to a signal processing chip in the electrode wire.

18. A stimulator system according to claim 17, wherein: The pulse generator comprises a memory and at least one processor, wherein the memory stores a computer program, and the at least one processor is configured to implement when executing the computer program: Receiving the digital signal to be tested output by the signal processing chip; A stimulation control instruction is generated according to the digital signal to be tested, and the stimulation control instruction is output to the signal processing chip.

19. A stimulator system according to claim 18, wherein: The at least one processor is configured to, when executing the computer program, further implement: Obtaining disease information of the subject; According to the disease information and the digital signal to be tested, setting a first duration and a second duration within a signal acquisition period; Wherein, during the first time period, at least one electrode contact transmits the stimulation pulse signal to the internal tissue of the subject, and at least one of the remaining electrode contacts collects the bioelectric signal of the subject; During the second time period, at least one electrode contact does not transmit the stimulation pulse signal, and at least one of the remaining electrode contacts collects the bioelectric signal of the object.

20. A computer-readable storage medium storing a computer program, wherein the computer program, when executed by at least one processor, implements the functions of the stimulator system according to any one of claims 17 to 19.

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