An electrode assembly and an implantable medical system

Abstract

This invention discloses an electrode assembly and an implantable medical system. The electrode assembly includes: at least one electrode pad configured to deliver electrical stimulation to a target site within a patient's body; electrode leads including a covering layer and at least one wire bundle encased within the covering layer; one end of each wire bundle connected to one of the electrode pads, and the other end of each wire bundle connected to a pulse generator; and an integrated circuit embedded in the implantation end of the covering layer, connected to the electrode pads and configured to acquire the stimulation current value delivered by the electrode pads. This invention's electrode assembly and implantable medical system can achieve accurate and safe delivery of electrical stimulation to a target site within a patient's body by acquiring stimulation current values ​​in real time.

Description

Technical Field

[0001] This invention relates to the technical field of implantable medical devices, and more particularly to an electrode assembly and an implantable medical system. Background Technology

[0002] Implantable medical systems, particularly implantable deep brain stimulation (DBS) systems, have shown great potential in the treatment of neurological diseases, with significant success in the treatment of Parkinson's disease. These systems typically consist of an implantable pulse generator (IPG), extension leads, and electrode leads, enabling precise control of electrical stimulation parameters and providing personalized treatment plans for patients.

[0003] However, existing DBS systems face some inherent technical challenges in electrode design. Traditional electrode leads often employ a ring-shaped contact design. While simple, this design results in a relatively large contact area with specific brain regions (such as the STN nuclei), leading to insufficiently concentrated charge density distribution, which may affect treatment efficacy. To optimize treatment outcomes, segmented contact electrode leads have gained popularity in recent years. Segmented contacts can significantly reduce the contact area with the STN nuclei, thereby increasing charge density and improving treatment precision and effectiveness. However, this design also introduces new problems: the significantly increased charge density also increases the risk of exceeding safety limits. Once the charge density exceeds the safe threshold, it may cause damage to the patient's brain tissue.

[0004] Furthermore, the internal guidewires of the DBS system (such as extension wires) may short-circuit due to various reasons (such as material aging, external damage, etc.), leading to an abnormal increase in the contact output current and further exacerbating the risk of exceeding charge density limits. Once this occurs, it will not only affect the treatment outcome but may also cause irreversible damage to the patient's health.

[0005] To address the aforementioned issues, those skilled in the art have been exploring safer and more reliable DBS system design solutions. Traditional overcurrent protection methods largely rely on monitoring and intervention from external circuits or devices. While this approach can reduce risk to some extent, it often suffers from drawbacks such as slow response speed and insufficient accuracy. Therefore, developing an implantable overcurrent protection device capable of real-time monitoring of electrode contact current and rapid response to over-limit conditions is particularly important.

[0006] In order to solve at least one of the above-mentioned technical problems, this application proposes an electrode assembly and an implantable medical system. Summary of the Invention

[0007] The purpose of this invention is to provide an electrode assembly and an implantable medical system that can deliver accurate and safe electrical stimulation to target points in the patient's body by acquiring stimulation current values ​​in real time.

[0008] The objective of this invention is achieved through the following technical solution:

[0009] On one hand, the present invention provides an electrode assembly, comprising:

[0010] At least one electrode pad, the electrode pad being configured to deliver electrical stimulation to a target site within the patient's body;

[0011] An electrode wire, the electrode wire including a coating layer and at least one wire bundle covered within the coating layer; one end of each wire bundle is connected to an electrode sheet, and the other end of each wire bundle is connected to a pulse generator;

[0012] An integrated circuit is embedded in the implantation end of the covering layer, the integrated circuit is connected to the electrode pad, and is configured to acquire the stimulation current value delivered by the electrode pad for electrical stimulation.

[0013] The beneficial effects of the above solution are as follows: The electrode assembly of the present invention precisely delivers electrical stimulation to the target point in the patient's body through at least one electrode pad, ensuring that the electrical stimulation can directly act on the area requiring treatment, thereby improving the treatment effect. The electrode lead includes a sheath and a bundle of wires encased within it, which not only provides good electrical connection but also increases the durability and biocompatibility of the lead. The sheath prevents the lead from directly contacting surrounding tissues, reducing the potential risk of irritation or damage. The integrated circuit is embedded in the implantation end of the sheath and directly connected to the electrode pad, making data acquisition more direct and accurate. The integrated circuit can acquire the stimulation current value when the electrode pad delivers electrical stimulation in real time, providing reliable data support for subsequent analysis and adjustment, thereby ensuring the accuracy and safety of electrical stimulation.

[0014] Furthermore, the integrated circuit is an ASIC chip.

[0015] The beneficial effects of the above solution are as follows: This invention uses an ASIC chip as an integrated circuit, which can significantly improve the performance and reliability of the electrode assembly, while reducing power consumption and cost.

[0016] Furthermore, the integrated circuit is provided with an overcurrent protection circuit, configured such that the overcurrent protection circuit includes:

[0017] At least one sampling module, wherein each sampling module corresponds one-to-one with the electrode pad, and each sampling module is disposed on the wire harness where its corresponding electrode pad is located, and is configured to collect the stimulation current value delivered by the corresponding electrode pad for electrical stimulation;

[0018] An amplification module, wherein the amplification module is connected in parallel with the sampling module;

[0019] A conversion module, the input of which is connected to the amplification module, and the output of which is communicatively connected to the control module.

[0020] The beneficial effects of the above solution are as follows: The overcurrent protection circuit of the present invention can monitor the stimulation current value delivered by the electrode in real time and take measures when the current exceeds the preset threshold to prevent the excessive current from causing harm to the patient, thereby improving the safety and reliability of the electrode assembly.

[0021] Furthermore, the overcurrent protection circuit also includes:

[0022] A touch switch is disposed between the sampling module and the amplification module.

[0023] The beneficial effects of the above solution are: the convenient touch switch of this invention enables the overcurrent protection circuit to respond quickly when needed, cutting off the current and thus protecting the patient from harm. At the same time, the touch switch also provides additional control flexibility.

[0024] Furthermore, the control module is integrated into the integrated circuit and communicates with the controller in the internal circuit of the pulse generator.

[0025] The beneficial effects of the above solution are as follows: By integrating the control module into the integrated circuit, the structure of the electrode assembly can be simplified, and the integration and reliability can be improved. At the same time, it enables the control module to communicate and coordinate more directly with the electrode plates and other circuit components.

[0026] Furthermore, the control module is integrated into the internal circuitry of the pulse generator, and the conversion module is connected to the control module via a communication link.

[0027] The beneficial effects of the above solution are as follows: By integrating the control module into the internal circuit of the pulse generator, the present invention can achieve more efficient communication and control, which helps to ensure the accurate transmission and reception of electrical stimulation pulse signals, while improving the overall performance of the system.

[0028] Furthermore, the control module is also configured to:

[0029] In response to the stimulation current value collected by the sampling module being greater than or equal to a preset threshold, the electrical stimulation pulse signal sent to the electrode corresponding to the sampling module is cut off.

[0030] The beneficial effects of the above solution are: the present invention can monitor the stimulation current value in real time and cut off the electrical stimulation pulse signal in time when the current is too large, thereby preventing harm to the patient and improving the safety and reliability of the electrode assembly.

[0031] Furthermore, the sampling module includes a sampling resistor;

[0032] The amplification module includes a current sensing amplifier, which is connected in parallel with the sampling resistor;

[0033] The conversion module includes an analog-to-digital converter, the input of which is connected to the output of the current sensing amplifier, and the output of which is communicatively connected to the control module.

[0034] The beneficial effects of the above solution are as follows: By employing components such as sampling resistors, current sensing amplifiers, and analog-to-digital converters, this invention can achieve precise acquisition and conversion of stimulation current values. This helps ensure the accuracy and reliability of the data, providing strong support for subsequent analysis and processing.

[0035] Furthermore, the amplification module also includes:

[0036] A first filter, the input of which is connected in parallel with the sampling resistor, and the output of which is connected to the input of the current-sensing amplifier; and / or,

[0037] The second filter has its input connected to the output of the current-sensing amplifier and its output connected to the input of the analog-to-digital converter.

[0038] The beneficial effects of the above solution are: the filter of the present invention can filter out interference signals and noise, improve the accuracy and reliability of the acquired data, and help ensure that the electrode assembly can still work stably in complex environments.

[0039] Furthermore, the electrode sheet is a ring-shaped electrode sheet and / or a sheet-shaped electrode sheet.

[0040] The beneficial effects of the above solutions are as follows: the annular electrode pads and sheet electrode pads of the present invention have different shapes and characteristics, which can meet different treatment needs and improve the flexibility and applicability of the electrode assembly.

[0041] Furthermore, the integrated circuit is an ASIC die, and the electrode plate is connected to the ASIC die via metal wires.

[0042] The beneficial effects of the above solution are: This invention uses ASIC bare dies as integrated circuits, which can further reduce costs and improve performance. At the same time, it makes the electrode assembly structure more compact and lightweight.

[0043] Furthermore, the electrode assembly also includes a support post, which is connected to the electrode wire;

[0044] The electrode sheet is attached to the surface of the support column;

[0045] When the electrode sheet is a ring-shaped electrode sheet, the plurality of electrode sheets are arranged at equal and / or unequal intervals;

[0046] When the electrode sheet is a sheet-shaped electrode sheet, multiple electrode sheets are arranged at equal intervals along the circumferential direction, and / or multiple electrode sheets are arranged at equal intervals along the length direction of the support column.

[0047] The beneficial effects of the above solution are: the support column of the present invention enables the electrode pads to be stably attached to its surface, and the reasonable arrangement can achieve a wider range of electrical stimulation coverage, which helps to improve the treatment effect and patient comfort.

[0048] Furthermore, the integrated circuit is embedded in the coating layer at one end near the electrode sheet.

[0049] The beneficial effects of the above solution are as follows: By embedding the integrated circuit in the coating layer at one end near the electrode sheet, the connection distance between the electrode sheet and the integrated circuit can be shortened, signal loss and interference can be reduced, and the accuracy and reliability of data acquisition can be improved.

[0050] On the other hand, the present invention provides an implantable medical system, comprising:

[0051] The aforementioned electrode assembly, wherein at least one electrode piece is implanted into a target site within the patient's body;

[0052] A pulse generator configured to transmit electrical stimulation pulse signals to at least one electrode sheet in the electrode assembly;

[0053] When at least one of the electrode pads delivers electrical stimulation to the target point, the stimulation current value delivered by the electrical stimulation by the at least one electrode pad is acquired using an integrated circuit in the electrode assembly.

[0054] The beneficial effects of the above solution are as follows: The implantable medical system of the present invention combines the advantages of electrode components and pulse generators, enabling precise electrical stimulation therapy of target points within the patient's body. Simultaneously, by acquiring and analyzing the stimulation current values ​​in real time, the accuracy and safety of the treatment can be ensured.

[0055] Furthermore, the pulse generator is configured as follows:

[0056] Identify at least one target electrode pad for the current delivery of electrical stimulation;

[0057] While the pulse generator outputs an electrical stimulation pulse signal, it sends a acquisition signal to the integrated circuit, causing the integrated circuit to acquire the stimulation current value delivered by at least one of the target electrode plates.

[0058] The beneficial effects of the above solution are as follows: The present invention can precisely control the electrical stimulation pulse signal of the target electrode sheet and collect the stimulation current value while sending the electrical stimulation pulse signal, which helps to improve the accuracy and real-time performance of the treatment.

[0059] Furthermore, the pulse generator is also configured to:

[0060] In response to any stimulation current value exceeding a preset threshold, the electrical stimulation pulse signal sent to the electrode corresponding to the stimulation current value is cut off, or an empty set is written into the electrical stimulation pulse signal sent to the electrode corresponding to the stimulation current value.

[0061] The beneficial effects of the above solution are: This invention can monitor the stimulation current value in real time and take timely measures when the current is too high to prevent harm to the patient. At the same time, by modifying the electrical stimulation pulse signal, flexible adjustments and optimizations to the treatment can be achieved.

[0062] Furthermore, the pulse generator is also configured to:

[0063] When any stimulation current value exceeds a preset threshold, the control module in the integrated circuit sends an instruction to stop sending electrical stimulation pulse signals to the electrode corresponding to the stimulation current value.

[0064] In response to the instruction, the stimulation module stops sending electrical stimulation pulse signals to the wire bundle corresponding to the electrode pad, the stimulation module being integrated into the internal circuitry of the pulse generator.

[0065] The beneficial effects of the above solution are as follows: This invention sends a stop command through the control module, which enables timely cutoff of electrical stimulation when the stimulation current value is too high, thus protecting the patient's safety.

[0066] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0067] This invention enables accurate and safe delivery of electrical stimulation to target points within a patient's body by real-time acquisition of stimulation current values. Specifically, the electrode assembly of this invention precisely delivers electrical stimulation to target points within the patient's body via at least one electrode pad, ensuring that the electrical stimulation directly acts on the area requiring treatment, thereby improving therapeutic efficacy. The electrode leads include a sheath and an encapsulated wire bundle, providing not only good electrical connection but also increased durability and biocompatibility. The sheath prevents direct contact between the leads and surrounding tissues, reducing the potential risk of irritation or damage. An integrated circuit is embedded in the implantation end of the sheath and directly connected to the electrode pad, making data acquisition more direct and accurate. The integrated circuit can acquire the stimulation current value during the delivery of electrical stimulation by the electrode pad in real time, providing reliable data support for subsequent analysis and adjustments, thereby ensuring the accuracy and safety of the electrical stimulation. Attached Figure Description

[0068] Figure 1 This is a schematic diagram of an electrode assembly according to an embodiment of the present invention.

[0069] Figure 2 This is another structural schematic diagram of the electrode assembly according to an embodiment of the present invention.

[0070] Figure 3 This is a schematic diagram of an integrated circuit according to an embodiment of the present invention.

[0071] Figure 4 This is another schematic diagram of the integrated circuit structure according to an embodiment of the present invention.

[0072] Figure 5 This is a schematic diagram of an implantable medical system according to an embodiment of the present invention.

[0073] In the figure: 1. Electrode sheet; 1a. First electrode sheet; 2a. Fourth electrode sheet; 1b. Second electrode sheet; 2b. Fifth electrode sheet; 1c. Third electrode sheet; 2c. Sixth electrode sheet; 2. Gold wire; 3. Pulse generator; 4. Integrated circuit; 5. Electrode wire; 51. Coating layer; 52. Wire harness; 6. Target point. Detailed Implementation

[0074] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided to make the invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0075] The terms used to express position and direction in this invention are illustrated with reference to the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this invention.

[0076] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, they are provided to make the invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0077] The terms used to express position and direction in this invention are illustrated with reference to the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this invention.

[0078] Below, we will first briefly describe one application area of ​​the present invention (i.e., implantable devices). An implantable neurostimulation system (an implantable medical system) mainly includes: a stimulator implanted in the patient's body and a programmed device placed outside the patient's body. Existing neuromodulation technology mainly involves implanting electrodes into specific structures (i.e., target points) within the body through stereotactic surgery, and then having the stimulator implanted in the patient's body send discharge pulses to the target points via the electrodes, modulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and relieving pain. The stimulator can be any one of an implantable neurostimulation device, an implantable cardiac stimulation system (also known as a pacemaker), an implantable drug delivery system (IDDS), or a lead adapter. Examples of implantable neurostimulation devices include: Deep Brain Stimulation (DBS), Cortical Nerve Stimulation (CNS), Spinal Cord Stimulation (SCS), Sacral Nerve Stimulation (SNS), and Vagus Nerve Stimulation (VNS).

[0079] In some embodiments, the stimulator may include: an implantable pulse generator (IPG), electrode leads, and an extension lead disposed between the IPG and the electrode leads, through which data interaction between the IPG and the electrode leads is achieved. The IPG is implanted within the patient's body. Responding to programmed commands from a programmable device, controllable electrical stimulation energy is provided to the body's tissues via a sealed battery and circuitry. One or two controllable electrical stimuli are delivered to specific areas of the body's tissues via the implanted extension lead and electrode leads. The extension lead, used in conjunction with the IPG, serves as a medium for transmitting electrical stimulation signals, conveying the electrical stimulation signals generated by the IPG to the electrode leads. The electrode leads deliver electrical stimulation to specific areas of the body's tissues via their electrode contacts. The stimulator has one or more electrode leads on one or both sides, and each electrode lead has multiple electrode contacts.

[0080] In other embodiments, the stimulator may consist only of an implantable pulse generator and electrode leads. The implantable pulse generator may be embedded in the patient's skull, and the electrode leads may be implanted intracranially, with the implantable pulse generator directly connected to the electrode leads, eliminating the need for extension leads.

[0081] The electrode leads can be neurostimulation electrodes, delivering electrical stimulation to specific areas of tissue within the body via multiple electrode contacts. The stimulator has one or more electrode leads on one or both sides, each with multiple electrode contacts arranged uniformly or non-uniformly around the circumference of the lead. As an example, the electrode contacts can be arranged in a 4x3 array (a total of 12 contacts) around the circumference of the lead. The electrode contacts can include stimulation contacts and / or acquisition contacts. For example, the electrode contacts can be sheet-like, ring-like, or dot-like shapes.

[0082] In some cases, the stimulated tissue can be the patient's brain tissue, and the stimulated site can be a specific area of ​​the brain tissue. The stimulated site generally differs depending on the patient's disease type, the number of stimulation contacts (single-source or multi-source), the application of one or more specific electrical stimulation signals (single-channel or multi-channel), and the stimulation parameter data. It can be assumed that using multiple stimulation contacts (multi-source, multi-channel) will generate a larger amount of data compared to using a single-source, single-channel approach.

[0083] This invention does not limit the types of diseases to which it is applicable, but can include those applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Specifically, DBS can be used to treat or manage diseases including, but not limited to: spastic disorders (e.g., epilepsy), pain, migraines, mental illnesses (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric disorders and impairments.

[0084] Stimulation parameters may include: stimulation frequency (e.g., the number of electrical stimulation pulse width signals per unit time 1 second, in Hz), pulse width (the duration of each pulse width, in μs), current amplitude (generally expressed as voltage, i.e., the intensity of each pulse width, in V), timing (e.g., continuous or triggered), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), physician control upper and lower limits (the range that physicians can adjust), and patient control upper and lower limits (the range that patients can adjust independently).

[0085] In medical fields such as neuromodulation, pain management, and muscle rehabilitation, electrode components are key parts of electrical stimulation therapy, and their performance and placement directly affect treatment outcomes. This invention aims to provide an electrode component and an implantable medical system to meet diverse treatment needs and provide precise and safe electrical stimulation therapy.

[0086] refer to Figure 1 and Figure 2 The electrode assembly of the present invention includes: at least one electrode sheet 1, an electrode wire 5, and an integrated circuit 4. The electrode assembly of the present invention may further include: a support post.

[0087] The electrode 1 of the present invention is configured to deliver electrical stimulation to a target 6 in the patient's body.

[0088] In application, electrode pad 1 can be either a ring-shaped electrode pad 1 or a sheet-shaped electrode pad 1. Ring-shaped electrode pad 1 provides a more uniform distribution of electrical stimulation, especially suitable for scenarios requiring broad coverage or encirclement of specific nerve or muscle tissue. Sheet-shaped electrode pad 1, placed on the target point 6, provides concentrated and high-intensity electrical stimulation, suitable for scenarios requiring precise stimulation of specific areas or points. In practical applications, the electrode assembly can contain a single type of electrode pad 1 (all ring-shaped or all sheet-shaped) or both types of electrode pads 1 to meet different treatment needs.

[0089] The electrode sheet 1 of the present invention is attached to the surface of the support column.

[0090] In application, when the electrode pad 1 is a ring-shaped electrode pad 1, multiple electrode pads 1 are arranged at equal and / or unequal intervals; when the electrode pad 1 is a sheet-shaped electrode pad 1, multiple electrode pads 1 are arranged at equal intervals along the circumference, and / or multiple electrode pads 1 are arranged at equal intervals along the length of the support column. Preferably, multiple electrode pads 1 are arranged at equal intervals along both the circumference and length of the support column. In practical applications, the support column is made of biocompatible material, and its shape can be designed according to treatment needs, such as cylindrical, conical, etc.

[0091] The electrode wire 5 of the present invention includes a rubber-made sheathing layer 51 and at least one wire bundle 52 covered within the sheathing layer 51.

[0092] In application, one end of each wire harness 52 is connected to an electrode pad 1, and the other end of the wire harness 52 is connected to a pulse generator 3, which is used to receive the stimulation current value delivered by the corresponding electrode pad 1 and send an electrical stimulation pulse signal to the corresponding electrode pad 1. In actual application, the pulse generator 3 is configured to send the electrical stimulation delivery signal to the electrode pad 1 and adjust parameters such as stimulation frequency and intensity according to treatment needs.

[0093] The integrated circuit 4 of this invention is an ASIC chip, specifically an ASIC die, and is embedded in the end of the covering layer 51 near the electrode sheet 1, for example, the implantation end of the covering layer 51. The implantation end can be understood as the part of the electrode assembly implanted in the patient's brain. In this way, the distance between the ASIC die and the electrode sheet is closer, which facilitates more efficient and rapid transmission of acquired data. Furthermore, the implantation end can also be the part of the electrode assembly that includes at least the electrode sheet. In this way, the ASIC chip is connected to the electrode sheet near the electrode sheet, thereby making the connection between the ASIC chip and the electrode sheet closer, the data transmission line shorter, and the loss less when transmitting acquired current data, thereby improving the reliability and stability of data transmission.

[0094] In application, integrated circuit 4 is connected to electrode 1. Preferably, the ASIC die is connected to electrode 1 via metal wires to collect the stimulation current value delivered by electrode 1. In practical applications, electrode 4 can be connected to the ASIC die via wire bonding (WB process); the connection between electronic components is achieved through the metal wires under the action of energy such as heat, pressure, and ultrasound.

[0095] To ensure the safety and effectiveness of the treatment, an overcurrent protection circuit is provided on integrated circuit 4. To address the safety issues that may be caused by excessive charge density and to achieve real-time monitoring and precise control of the stimulation current at the electrode contacts, the overcurrent protection circuit of this invention integrates multiple modules such as sampling, amplification, conversion, and touch switch.

[0096] Specifically, the overcurrent protection circuit of the present invention includes: at least one sampling module, an amplification module, and a conversion module.

[0097] Furthermore, the overcurrent protection circuit of the present invention also includes a touch switch.

[0098] The sampling module of the present invention includes a sampling resistor for acquiring the electrical stimulation current value delivered by the electrode 1.

[0099] In application, the sampling modules and electrode pads 1 are paired one-to-one. Each sampling module is installed on the wiring harness 52 where its corresponding electrode pad 1 is located, and is configured to collect the stimulation current value delivered by the corresponding electrode pad 1. For example: the first sampling resistor R S1 Corresponding to the first electrode 1a, the second sampling resistor R S2 Corresponding to the second electrode 1b, the third sampling resistor R S3 Corresponding to the third electrode plate 1c, the fourth sampling resistor R S4 Corresponding to the fourth electrode 2a, the fifth sampling resistor R S5 Corresponding to the fifth electrode 2b, the sixth sampling resistor R S6 Corresponding to the sixth electrode plate 2c.

[0100] The amplification module and the sampling module of the present invention are connected in parallel to amplify the sampled current according to a preset ratio, so as to enhance the intensity of the acquired current signal for subsequent processing.

[0101] In application, the amplification module includes a current sensing amplifier connected in parallel with the sampling resistor, which can amplify the current signal on the sampling resistor in real time.

[0102] In practical applications, the amplification module also includes filters. Further, the filters include a first filter and / or a second filter. The input of the first filter is connected in parallel with the sampling resistor, and its output is connected to the input of the current-sense amplifier, used for initial filtering of high-frequency noise. The input of the second filter is connected to the output of the current-sense amplifier, and its output is connected to the input of the analog-to-digital converter, used for further signal smoothing and improving conversion accuracy.

[0103] The input end of the conversion module of the present invention is connected to the amplification module, and the output end of the conversion module is communicatively connected to the control module to convert the amplified signal into a digital signal so as to communicate with the control module.

[0104] In application, the conversion module includes an analog-to-digital converter (ADC). The input of the ADC is connected to the output of the current sensing amplifier, and the output of the ADC is connected to the control module. This enables the control module to acquire the stimulation current data of each electrode 1 in real time, thereby achieving precise control of the entire DBS system.

[0105] The touch switch of this invention is disposed between the sampling module and the amplification module to disconnect the circuit when necessary and prevent overcurrent damage. In an embodiment of this invention, a touch switch is disposed between each sampling resistor and the amplification module. For example: the first sampling resistor R S1 A first touch switch S1 and a second sampling resistor R are set between the amplifier module and the amplifier module. S2 A second touch switch S2 and a third sampling resistor R are set between the amplifier module and the amplifier module. S3 A third touch switch S3 and a fourth sampling resistor R are set between the amplifier module and the amplifier module. S4 A fourth touch switch S4 and a fifth sampling resistor R are installed between the amplifier module and the amplifier module. S5 A fifth touch switch S5 and a sixth sampling resistor R are installed between the amplifier module and the amplifier module. S6 A sixth touch switch S6 is installed between the control module and the amplification module. When the control module detects that the stimulation current value of a certain electrode 1 exceeds the limit, it can immediately turn off the corresponding touch switch, thereby cutting off the output of the electrode 1 and protecting the patient from harm.

[0106] refer to Figure 4In some embodiments, the control module is integrated into the integrated circuit 4 and communicates with the controller in the internal circuit of the pulse generator 3. In application, the control module and the controller in the internal circuit of the pulse generator 3 communicate wirelessly or via a wired connection. The pulse generator 3 is responsible for sending electrical stimulation delivery signals to the electrode pads 1, and its internal circuit controller communicates with the control module to receive control commands. Furthermore, the control module has a preset threshold for the stimulation current value. When the stimulation current value collected by any sampling module reaches or exceeds the preset threshold, the control module will cut off the electrical stimulation pulse signal sent to the electrode pad 1 corresponding to that sampling module, thereby preventing damage caused by overcurrent.

[0107] In practical applications, the electrode assembly is implanted into the patient's body and connected to the pulse generator 3. The pulse generator 3 begins sending electrical stimulation signals, while the sampling module in the integrated circuit 4 begins acquiring the stimulation current values ​​of each electrode pad 1. The conversion module converts the acquired analog signals into digital signals and transmits them to the control module. The control module monitors the stimulation current values ​​in real time and compares them with preset thresholds. If the stimulation current value of a certain electrode pad 1 reaches or exceeds the threshold, the control module immediately cuts off the electrical stimulation pulse signal sent to that electrode pad 1.

[0108] refer to Figure 3 In other embodiments, the control module is integrated into the internal circuitry of the pulse generator 3, and the conversion module is connected to the control module via a communication harness 52. In application, the integrated circuit 4 collects the stimulation current values ​​of each electrode 1 and converts them into digital signals, which are then transmitted to the control module in the pulse generator 3. Furthermore, the control module has a preset threshold for the stimulation current value. When the stimulation current value of any electrode 1 transmitted by the conversion module reaches or exceeds the preset threshold, the control module adjusts the output of the pulse generator 3, cutting off or reducing the intensity of the electrical stimulation pulse signal sent to that electrode 1.

[0109] In some preferred embodiments, to further enhance the safety and effectiveness of treatment and implement multiple safety control mechanisms, the electrode assembly of the present invention simultaneously includes a first control module in the integrated circuit 4 and a second control module in the internal circuit of the pulse generator 3. The two modules work collaboratively via a communication protocol to jointly monitor and control the stimulation current value. During application, the electrode assembly is implanted into the patient and connected to the pulse generator 3, which integrates dual control modules. The pulse generator 3 begins sending electrical stimulation pulse signals, while the sampling module in the integrated circuit 4 begins collecting the stimulation current value of each electrode 1. The conversion module converts the collected analog signals into digital signals and transmits them to the first and second control modules respectively. The two control modules monitor the stimulation current value in real time and work collaboratively according to preset conditions, adjusting the output of the electrical stimulation signal or taking corresponding safety measures. When an abnormality is detected, such as when the stimulation current value exceeds a preset threshold, the control module will immediately cut off the electrical stimulation pulse signal and activate the alarm system.

[0110] refer to Figure 5 In order to achieve precise electrical stimulation therapy and monitor the stimulation current value in real time during the electrical stimulation process to ensure the safety and effectiveness of the treatment, the implantable medical system proposed in this invention includes: the above-mentioned electrode assembly and pulse generator 3.

[0111] The electrode wires 5 in the electrode assembly connect the electrode pads 1 and the pulse generator 3, ensuring accurate transmission of electrical signals. In application, at least one electrode pad 1 in the electrode assembly is implanted into the target site 6 within the patient's body to deliver electrical stimulation to the target site. Furthermore, the electrode pad 1 can be ring-shaped or sheet-shaped, with the appropriate type and layout selected according to treatment needs. In practical applications, the integrated circuit 4 in the electrode assembly is embedded within the covering layer 51 and connected to the electrode pad 1 via gold wires 2. The integrated circuit 4 is responsible for acquiring the stimulation current value when the electrode pad 1 delivers electrical stimulation and sending the data to the pulse generator 3.

[0112] The pulse generator 3 of the present invention is configured to determine at least one target electrode 1 for current electrical stimulation delivery, send an electrical stimulation pulse signal to at least one electrode 1 in the electrode assembly, and, when at least one electrode 1 delivers electrical stimulation to the target point 6, acquire the stimulation current value of the electrical stimulation delivered by at least one electrode 1 using the integrated circuit 4 in the electrode assembly. Specifically, the pulse generator 3 is connected to the integrated circuit 4 through a communication interface, receives the acquired stimulation current value, and adjusts the output of the electrical stimulation pulse signal according to preset conditions. Furthermore, a stimulation module is integrated into the internal circuitry of the pulse generator 3, responsible for generating and sending electrical stimulation pulse signals to the electrode 1. The control module may be integrated as part of the internal circuitry of the pulse generator 3 or integrated into the integrated circuit 4; the stimulation module and the control module exchange data through a communication protocol. The control module is responsible for determining the electrode 1 for current electrical stimulation delivery, sending an acquisition signal to the integrated circuit 4, and simultaneously performing safety monitoring based on the acquired stimulation current value.

[0113] In application, while the pulse generator 3 outputs an electrical stimulation pulse signal, it simultaneously sends a data acquisition signal to the integrated circuit 4 via a communication interface. Upon receiving the acquisition signal, the integrated circuit 4 begins acquiring the stimulation current value delivered by electrode 1 during electrical stimulation, acquiring the stimulation current value delivered by at least one target electrode 1. In practical applications, to ensure data acquisition throughout the entire stimulation process, the acquisition signal can be sent to the integrated circuit 4 before the pulse generator outputs the electrical stimulation pulse signal and continue for a period of time after the electrical stimulation ends.

[0114] In some embodiments, the control module is integrated into the internal circuitry of the pulse generator 3, and the conversion module is connected to the control module via a communication harness 52. The pulse generator 3 is also configured to: in response to any stimulation current value being greater than a preset threshold, cut off the electrical stimulation pulse signal sent to the electrode 1 corresponding to the stimulation current value or write an empty set into the electrical stimulation pulse signal sent to the electrode 1 corresponding to the stimulation current value.

[0115] In application, the stimulation module is integrated into the internal circuitry of the pulse generator 3, responsible for generating and sending electrical stimulation pulse signals to electrode 1. The control module is also integrated into the internal circuitry of the pulse generator 3. The control module is connected to the conversion module in the integrated circuit 4 via communication harness 52, receiving the acquired stimulation current value. In practical applications, a preset threshold for the stimulation current value is set within the control module. The control module monitors the stimulation current value in real time and compares it with the preset threshold. When the stimulation current value of any electrode 1 is greater than or equal to the preset threshold, the control module will cut off or adjust the electrical stimulation pulse signal sent to that electrode 1, for example, by directly cutting off the signal or writing an empty set (i.e., no signal) into the corresponding signal channel.

[0116] In other embodiments, the control module is integrated into the integrated circuit 4 and communicates with the controller in the internal circuit of the pulse generator 3. The pulse generator 3 is also configured such that when any stimulation current value is greater than a preset threshold, the control module in the integrated circuit 4 sends an instruction to stop sending electrical stimulation pulse signals to the electrode 1 corresponding to the stimulation current value; in response to the instruction, the stimulation module stops sending electrical stimulation pulse signals to the wire harness 52 corresponding to the electrode 1, and the stimulation module is integrated into the internal circuit of the pulse generator 3.

[0117] In application, the stimulation module is integrated into the internal circuitry of the pulse generator 3, responsible for generating and transmitting electrical stimulation pulse signals. The communication interface of the pulse generator 3 is used to communicate with the control module in the integrated circuit 4. The communication interface can be wireless (e.g., Bluetooth, Wi-Fi) or wired (e.g., USB, serial port). The controller can receive instructions from the control module in the integrated circuit 4 and adjust the output of the electrical stimulation pulse signal accordingly. In practical applications, the control module is responsible for monitoring the stimulation current value of electrode 1 in real time and comparing it with a preset threshold. When any stimulation current value exceeds the preset threshold, the control module sends a command to the pulse generator 3, requesting that the transmission of electrical stimulation pulse signals to that electrode 1 be stopped.

[0118] In another embodiment of this specification, an implantable medical system is also provided, comprising a stimulator, wherein the stimulator includes an implantable pulse generator (IPG), extension leads, and electrodes. The electrodes consist of a rubber tube, electrode contacts (electrode pads), a bare die, and adhesive. The rubber tube serves as structural support; the metal contacts attached to the outer wall of the rubber tube serve as electrode contacts; the bare die is an ASIC die integrating current detection circuits for each contact circuit; the electrode contacts are connected to the bare die via gold wires (based on WB technology).

[0119] The bare die internally incorporates an electrode overcurrent protection circuit, including sampling resistors RS1-RS6, switches S1-S6, a current sensing amplifier, and an analog-to-digital converter. The sampling resistors RS1-RS6 are added between the stimulation module and each electrode contact. The current sensing amplifier collects the real-time current of electrode contacts 1a-2c by switching switches S1-S6. After being amplified by the current sensing amplifier and converted by the analog-to-digital converter, the current is sent to the MCU module for processing. An application-specific integrated circuit (ASIC) is embedded inside the electrodes of the stimulator to collect the real-time stimulation current waveform of each contact in the STN nucleus, serving as the basis for determining if the contact charge density exceeds the limit. When an overcurrent is detected at an electrode contact, i.e., when the charge density near that electrode contact exceeds the limit, the MCU module promptly sends a control command to cut off the stimulation module's output to that electrode contact, thus preventing harm to the patient from DBS treatment.

[0120] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the invention without departing from the principles and spirit of the invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. An electrode assembly, characterized in that, include: At least one electrode pad, the electrode pad being configured to deliver electrical stimulation to a target site within the patient's body; An electrode wire, the electrode wire including a coating layer and at least one wire bundle covered within the coating layer; one end of each wire bundle is connected to an electrode sheet, and the other end of each wire bundle is connected to a pulse generator; An integrated circuit is embedded in the implantation end of the covering layer, the integrated circuit is connected to the electrode pad, and is configured to acquire the stimulation current value delivered by the electrode pad for electrical stimulation.

2. The electrode assembly according to claim 1, characterized in that, The integrated circuit is an ASIC chip.

3. The electrode assembly according to claim 1, characterized in that, The integrated circuit is provided with an overcurrent protection circuit, which includes: At least one sampling module, wherein each sampling module corresponds one-to-one with the electrode pad, and each sampling module is disposed on the wire harness where its corresponding electrode pad is located, and is configured to collect the stimulation current value delivered by the corresponding electrode pad for electrical stimulation; An amplification module, wherein the amplification module is connected in parallel with the sampling module; A conversion module, the input of which is connected to the amplification module, and the output of which is communicatively connected to the control module.

4. The electrode assembly according to claim 3, characterized in that, The overcurrent protection circuit also includes: A touch switch is disposed between the sampling module and the amplification module.

5. The electrode assembly according to claim 3, characterized in that, The control module is integrated into the integrated circuit and communicates with the controller in the internal circuit of the pulse generator.

6. The electrode assembly according to claim 3, characterized in that, The control module is integrated into the internal circuit of the pulse generator, and the conversion module is connected to the control module via a communication link.

7. The electrode assembly according to claim 3, characterized in that, The control module is also configured to: In response to the stimulation current value collected by the sampling module being greater than or equal to a preset threshold, the electrical stimulation pulse signal sent to the electrode corresponding to the sampling module is cut off.

8. The electrode assembly according to claim 3, characterized in that, The sampling module includes a sampling resistor; The amplification module includes a current sensing amplifier, which is connected in parallel with the sampling resistor; The conversion module includes an analog-to-digital converter, the input of which is connected to the output of the current sensing amplifier, and the output of which is communicatively connected to the control module.

9. The electrode assembly according to claim 8, characterized in that, The amplification module also includes: A first filter, the input of which is connected in parallel with the sampling resistor, and the output of which is connected to the input of the current-sensing amplifier; and / or, The second filter has its input connected to the output of the current-sensing amplifier and its output connected to the input of the analog-to-digital converter.

10. The electrode assembly according to claim 1, characterized in that, The electrode sheet is a ring-shaped electrode sheet and / or a sheet-shaped electrode sheet.

11. The electrode assembly according to claim 1, characterized in that, The integrated circuit is an ASIC die, and the electrode plate is connected to the ASIC die via metal wires.

12. The electrode assembly according to claim 1, characterized in that, The electrode assembly further includes: a support post, the support post being connected to the electrode wire; The electrode sheet is attached to the surface of the support column; When the electrode sheet is a ring-shaped electrode sheet, the plurality of electrode sheets are arranged at equal and / or unequal intervals; When the electrode sheet is a sheet-shaped electrode sheet, multiple electrode sheets are arranged at equal intervals along the circumferential direction, and / or multiple electrode sheets are arranged at equal intervals along the length direction of the support column.

13. The electrode assembly according to claim 1, characterized in that, The integrated circuit is embedded in the coating layer at one end near the electrode sheet.

14. An implantable medical system, characterized in that, include: The electrode assembly according to any one of claims 1-13, wherein at least one electrode pad of the electrode assembly is implanted into a target site within the patient's body; A pulse generator configured to transmit electrical stimulation pulse signals to at least one electrode sheet in the electrode assembly; When at least one of the electrode pads delivers electrical stimulation to the target point, the stimulation current value delivered by the electrical stimulation by the at least one electrode pad is acquired using an integrated circuit in the electrode assembly.

15. The implantable medical system according to claim 14, characterized in that, The pulse generator is configured to: Identify at least one target electrode pad for the current delivery of electrical stimulation; While the pulse generator outputs an electrical stimulation pulse signal, it sends a acquisition signal to the integrated circuit, causing the integrated circuit to acquire the stimulation current value delivered by at least one of the target electrode plates.

16. The implantable medical system according to claim 14, characterized in that, The pulse generator is also configured to: In response to any stimulation current value exceeding a preset threshold, the electrical stimulation pulse signal sent to the electrode corresponding to the stimulation current value is cut off, or an empty set is written into the electrical stimulation pulse signal sent to the electrode corresponding to the stimulation current value.

17. The implantable medical system according to claim 14, characterized in that, The pulse generator is also configured to: When any stimulation current value exceeds a preset threshold, the control module in the integrated circuit sends an instruction to stop sending electrical stimulation pulse signals to the electrode corresponding to the stimulation current value. In response to the instruction, the stimulation module stops sending electrical stimulation pulse signals to the wire bundle corresponding to the electrode pad, the stimulation module being integrated into the internal circuitry of the pulse generator.

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