Stimulation chip, stacked chip, pulse generator and stimulator

Abstract

The application provides a stimulation chip, a stacked chip, a pulse generator and a stimulator, and the stimulation chip comprises: an electrical interface module, which is used for receiving a stimulation control signal sent by the single-chip microcomputer and outputting; a pulse control module, which is used for receiving the stimulation control signal and outputting a pulse control signal; a plurality of pulse generation modules; a plurality of switch modules, at least one of which is used for receiving the stimulation pulse signal and outputting to two selected stimulation transmission conductors, so that the two selected stimulation transmission conductors transmit the stimulation pulse signal to corresponding electrode contacts respectively and release electric stimulation energy; and a voltage measurement module, which is used for measuring the voltage value between the electrode contacts corresponding to the two selected stimulation transmission conductors and outputting to the single-chip microcomputer. The stimulation chip can simultaneously generate a plurality of stimulation pulse signals with different stimulation parameters and selectively transmit the stimulation pulse signals to two stimulation transmission conductors, has high integration and strong anti-interference performance.

Description

Technical Field

[0001] This application relates to the technical field of implantable medical devices, and more particularly to stimulation chips, stacked chips, pulse generators and stimulators. Background Technology

[0002] Deep brain stimulation (DBS) is a type of implantable medical device that typically includes a pulse generator, a stimulation delivery lead, and electrode leads. The electrode leads have multiple electrode contacts. The stimulation pulse signals generated by the pulse generator are transmitted to the electrode contacts via the stimulation delivery lead, and the electrode contacts release electrical stimulation energy to the surrounding brain tissue. Generally, the pulse generator is implanted in the chest, the stimulation delivery lead is implanted in the cortex, and the electrode leads are implanted intracranially. Brain stimulation, also known as deep brain stimulation, involves implanting electrodes into specific neural nuclei in the brain (such as the subthalamic nucleus) to release high-frequency electrical stimulation. This inhibits the electrical impulses of neurons that are overexcited due to a reduction in dopaminergic neurons, reducing their hyperexcitation state and thus alleviating Parkinson's disease symptoms. Deep brain stimulation surgery uses stereotactic surgery to implant stimulation electrodes into the lesion site in the brain of Parkinson's disease patients, and implants the pulse generator subcutaneously in the patient's chest. The electrical pulse stimulation acts on specific areas of the brain, thereby improving the symptoms of Parkinson's disease, essential tremor, and other related conditions. This surgery can effectively reduce the main symptoms of Parkinson's disease, such as tremor, rigidity, and bradykinesia.

[0003] Patent CN102580243B discloses an implantable dual-mode stimulation chip, system, and mode switching method. The dual-mode electrical stimulation chip includes: a digital control module for outputting digital control signals to control the output of stimulation pulses; an analog pulse generation module connected to the digital control module, comprising a constant-voltage stimulation generation circuit and a constant-current stimulation generation circuit for generating constant-voltage or constant-current stimulation pulses; an output control module connected to both the digital control module and the analog pulse generation module for outputting constant-voltage or constant-current stimulation pulses externally through electrodes; and a stimulation output measurement module connected to both the digital control module and the output control module. The stimulation output measurement module is controlled by the digital control module... The control module measures the stimulation voltage or stimulation current output by the output control module and feeds it back to the digital control module. The dual-mode electrical stimulation chip has two stimulation modes: constant voltage stimulation mode and constant current stimulation mode. In constant voltage stimulation mode, the constant voltage stimulation generation circuit of the analog pulse generation module generates a constant voltage stimulation pulse output. In constant current stimulation mode, the constant current stimulation generation circuit of the analog pulse generation module generates a constant current stimulation pulse output. The constant voltage stimulation generation circuit includes a reference current generation module, a reference voltage generation module obtained by calculating the reference current generation module, a voltage feedback amplification module for amplifying the output voltage of the reference voltage generation module, and a constant voltage stimulation operational amplification output module. The reference current generation module includes a programmable current digital-to-analog converter circuit (Current Current). The circuit includes a current converter (DAC) for generating a reference current (Idac); the reference voltage generation module includes a first resistor (Rdac), the input of which is connected to the output of the programmable current digital-to-analog converter (Current DAC), and its two ends are used to generate a reference voltage (Vdac); the voltage feedback amplification module includes a first feedback voltage divider resistor (Rfb) and a second feedback voltage divider resistor (Rfn) connected in series between the stimulation pulse output terminal and the stimulation ground output terminal, and the feedback voltage (Vs_fb) generated across the second feedback voltage divider resistor (Rfn) is used to adjust the stimulation voltage pulse output to a set value;The constant-voltage stimulation operational amplifier output module includes an operational amplifier (A1). The non-inverting input of the operational amplifier (A1) is connected to the input of the first resistor (Rdac) to input the reference voltage (Vdac). The inverting input of the operational amplifier is connected to the connection between the first feedback voltage divider resistor (Rfb) and the second feedback voltage divider resistor (Rfn) to input the feedback voltage (Vs_fb) to the operational amplifier (A1). The operational amplifier (A1) amplifies the reference voltage (Vdac) to generate a constant-voltage stimulation voltage output. The constant-current stimulation generation circuit includes the reference current generation module and a current feedback amplification module that amplifies the output current of the reference current generation module. It supports both constant-voltage and constant-current stimulation modes, allowing doctors or patients to select either mode using an external control device. However, this dual-mode electrical stimulation chip has only one stimulation source and can only selectively output constant-voltage or constant-current stimulation pulses.

[0004] Therefore, there is a need to provide a stimulation chip with multiple stimulation sources, capable of outputting one or more stimulation pulses. Summary of the Invention

[0005] The purpose of this application is to provide a stimulation chip, a stacked chip, a pulse generator, and a stimulator, which have multiple stimulation sources and are capable of outputting one or more stimulation pulses.

[0006] The objective of this application is achieved through the following technical solution:

[0007] In a first aspect, this application provides a stimulation chip, the stimulation chip comprising:

[0008] An electrical interface module is electrically connected to a microcontroller. The electrical interface module is used to receive and output stimulation control signals sent by the microcontroller.

[0009] A pulse control module is electrically connected to the electrical interface module. The pulse control module is used to receive the stimulation control signal and output a pulse control signal.

[0010] Multiple pulse generation modules are provided, each of which is electrically connected to the pulse control module. Each pulse generation module is used to receive the pulse control signal and output a stimulation pulse signal.

[0011] Multiple switching modules and multiple pulse generation modules are electrically connected in a one-to-one correspondence. Each switching module is connected to multiple stimulation transmission wires so that each stimulation transmission wire is connected to one of the switching modules. At least one switching module is used to receive the stimulation pulse signal and output it to two selected stimulation transmission wires so that the two selected stimulation transmission wires transmit the stimulation pulse signal to the corresponding electrode contacts and release electrical stimulation energy.

[0012] A voltage measurement module is electrically connected to the two selected stimulus transmission wires and the microcontroller, respectively. The voltage measurement module is used to measure the voltage value between the electrode contacts corresponding to the two selected stimulus transmission wires and output it to the microcontroller.

[0013] The beneficial effects of this technical solution are as follows: It utilizes an electrical interface module to interact with a microcontroller, receives stimulation control signals and transmits them to a pulse control module, outputs pulse control signals using the pulse control module, and generates one or more stimulation pulse signals using one or more pulse generation modules (i.e., stimulation sources). These stimulation pulse signals are transmitted through a switching module to two selected stimulation transmission leads (the stimulation pulse signals received by the two stimulation transmission leads can be from the same stimulation source or different stimulation sources). These two stimulation transmission leads then transmit the signals to corresponding electrode contacts, which release electrical stimulation energy into the surrounding tissues, thus providing electrical stimulation therapy to the patient. On the one hand, multiple pulse generation modules are set up to simultaneously generate various stimulation pulse signals with different stimulation parameters. On the other hand, a switching module is set up to selectively transmit the generated stimulation pulse signals to two of the stimulation transmission leads, facilitating medical personnel to observe the voltage signals (voltage values) between specific combinations of electrode contacts. Furthermore, this stimulation chip integrates multiple pulse generation modules and multiple switching modules into one unit, resulting in high integration and a small footprint. For implantable medical devices, which are sensitive to product size and space, this can help reduce the overall size of the product and broaden its application prospects. In addition, the stimulation chip and the microcontroller are set up separately. The microcontroller is responsible for data interaction with external devices. For example, the microcontroller obtains the programmable signals provided by the external programmable device through wireless communication chips such as Bluetooth chips, parses the stimulation parameter information, and outputs stimulation control signals. In this way, the stimulation chip does not have direct data interaction with external devices, avoiding external electromagnetic wave interference with the output of the stimulation chip and providing strong anti-interference capabilities.

[0014] In some alternative implementations, at least one of the switching modules is configured to receive the stimulation pulse signal, output a positive stimulation pulse signal to one of the two selected stimulation delivery wires, and output a negative stimulation pulse signal to the other of the two selected stimulation delivery wires.

[0015] The beneficial effects of this technical solution are as follows: one or more switching modules receive stimulation pulse signals and output them to two stimulation transmission leads. For example, when one switching module receives a stimulation pulse signal, it can selectively output a positive or negative stimulation pulse signal through a micro-switch between the switching module and each stimulation transmission lead (one flips while the other remains unchanged, thus obtaining an opposite stimulation pulse signal). For instance, a positive stimulation pulse signal can be output to one stimulation transmission lead, and a negative stimulation pulse signal can be output to the other. When two switching modules receive a stimulation pulse signal, they can obtain opposite stimulation pulses through the micro-switches between each switching module and its corresponding stimulation transmission lead (one flips while the other remains unchanged). The signal can selectively output positive or negative stimulation pulse signals. For example, it can output a positive stimulation pulse signal to one stimulation transmission wire and a negative stimulation pulse signal to the other stimulation transmission wire. When the two switch modules receive two stimulation pulse signals, if the two stimulation pulse signals are one positive and one negative, they can output one positive and one negative stimulation pulse signal to the two stimulation transmission wires respectively through microswitches (the microswitches corresponding to the two stimulation transmission wires do not flip or both flip). If the two stimulation pulse signals are both positive or both are negative, the received stimulation pulse signal can be flipped by the microswitch corresponding to one stimulation transmission wire, thereby outputting one positive and one negative stimulation pulse signal to the two stimulation transmission wires respectively.

[0016] The two selected stimulation transmission leads receive positive and negative stimulation pulse signals, respectively. These two opposing stimulation pulse signals act on different tissues or neurons in the body, which facilitates the formation of a larger voltage difference between the two electrode contacts. This allows for more accurate acquisition of the stimulation voltage signal between the two electrode contacts when the electrode contacts are releasing electrical stimulation energy (stimulation state).

[0017] In some alternative implementations, the electrical interface module is an SPI interface module.

[0018] The beneficial effects of this technical solution are as follows: SPI, short for Serial Peripheral Interface, is a synchronous serial interface technology. It is a high-speed, full-duplex, synchronous communication bus with advantages such as supporting full-duplex operation, simple operation, and high data transmission rate. Using an SPI interface module as the data interaction interface between the microcontroller and the microcontroller can provide high data transmission efficiency and support bidirectional data transmission.

[0019] In some alternative implementations, the number of pulse generation modules and the number of switching modules are both two.

[0020] The beneficial effect of this technical solution is that two pulse generation modules and two switching modules are set in the stimulation chip. If too many pulse generation modules and switching modules are set in the stimulation chip, it will lead to an increase in volume, which may be detrimental to implantation in the patient's body (it may cause inconvenience to the patient's life or cause discomfort to the patient). Therefore, two of each can be set.

[0021] In some alternative embodiments, the stimulation chip is fabricated using a 0.35µm CMOS process.

[0022] The beneficial effects of this technical solution are: by employing precise processing techniques, it can provide high-quality, stable stimulation chips. Unlike external medical devices, which sometimes have lower processing precision but do not necessarily affect their use, or whose malfunctions are tolerated by a high degree of tolerance, allowing medical staff and patients to easily switch to other devices, implanted medical devices are different. Once implanted, these devices are generally not frequently replaced, or replacement is costly (requiring surgery to remove the old device and insert the new one). On one hand, patients have to pay for the doctor's replacement surgery (unlike external medical devices), and on the other hand, they endure significant pain (unlike external medical devices). Therefore, as part of an implantable medical device, the stimulation chip itself requires higher processing precision, higher quality, and better stability to avoid the need for frequent replacements.

[0023] In addition, patients with implantable medical devices are often those with Parkinson's disease, obsessive-compulsive disorder, depression, addiction, etc., who require continuous electrical stimulation therapy. When they do not receive effective stimulation therapy, patients with depression may commit suicide, and drug addicts may relapse. This is something that medical staff, patients, and society as a whole do not want to see. These characteristics determine that implantable medical devices as a whole require more technical content and higher standards of processing technology.

[0024] Secondly, this application provides a stacked chip, the stacked chip comprising:

[0025] At least one stimulation chip as described in any one of the first aspects;

[0026] A switching chip, wherein the switching chip is respectively connected to each switching module of each of the stimulation chips and each stimulation delivery wire;

[0027] At least one of the switching modules is used to receive stimulation pulse signals and output them through the switching chip to two selected stimulation delivery wires.

[0028] The beneficial effects of this technical solution are as follows: Chip stacking technology can stack and interconnect multiple existing chips, components, packages, and even wafers to form a three-dimensional package, significantly increasing assembly density. This promotes the development of implantable medical devices towards high density, high reliability, low power consumption, high speed, and miniaturization. It boasts advantages such as small size, high development efficiency, and rapid fulfillment of new product application needs. Furthermore, the process is largely compatible with traditional processes, and with improvements, it can be quickly produced and launched into the market, demonstrating broad development prospects. The stacked chip prepared using chip stacking technology has one or more stimulation chips and one switch chip. This integrates an additional switch chip and stimulation chip into one unit, providing the opportunity for simultaneous stimulation therapy from the pulse generation modules (stimulation sources) of different stimulation chips. For example, the switch chip can control one stimulation source on each of two stimulation chips to simultaneously generate stimulation pulses, or even control more stimulation sources on more stimulation chips to simultaneously generate stimulation pulses. This provides a broader application prospect for stimulation therapy methods.

[0029] In some alternative implementations, the number of stimulation chips is greater than one;

[0030] The two selected stimulation delivery wires are respectively connected to different switching modules, and the two switching modules connected to the two selected stimulation delivery wires are located in different stimulation chips.

[0031] The beneficial effect of this technical solution is that the stacked chip has two or more stimulation chips, and stimulation pulses are generated simultaneously by the stimulation sources on two of the stimulation chips.

[0032] In some alternative implementations, the number of stimulation chips is two.

[0033] The beneficial effect of this technical solution is that two stimulation chips are set in the stacked chip. If there are too many stimulation chips in the stacked chip, it will lead to an increase in volume (each stimulation chip has a circuit between it and the switch chip), which may be detrimental to implantation in the patient's body (it may cause inconvenience to the patient's life or cause discomfort to the patient). Therefore, two stimulation chips can be set.

[0034] Thirdly, this application provides a pulse generator, the pulse generator comprising:

[0035] A microcontroller, wherein the microcontroller is used to output stimulation control signals;

[0036] The stimulation chip as described in any of the first aspects or the stacked chip as described in any of the second aspects;

[0037] Multiple sampling resistors are provided, and each pulse generation module and each switching module are electrically connected in a one-to-one correspondence through one of the sampling resistors;

[0038] Multiple impedance measurement modules are provided, each of which is electrically connected to both ends of a sampling resistor and a microcontroller. Each impedance measurement module measures the voltage across the sampling resistor and outputs it to the microcontroller, so that the microcontroller can calculate the current value in the stimulation path formed by the two stimulation transmission leads based on the voltage value across the sampling resistor and the resistance value of the sampling resistor, and calculate the impedance value of the biological tissue between the electrode contacts corresponding to the two stimulation transmission leads based on the voltage value between the electrode contacts corresponding to the two stimulation transmission leads and the current value in the stimulation path.

[0039] The beneficial effects of this technical solution are as follows: The pulse generator includes a microcontroller, a stimulation chip or stacked chips, multiple sampling resistors, and multiple impedance measurement modules. It can measure the current value in the stimulation pathway (i.e., the conductive pathway where the electrode contacts are located) under stimulation conditions and calculate the impedance value of the biological tissue between the two electrode contacts by combining the current value with the voltage value between the two electrode contacts. The impedance value calculated in this way can accurately reflect the impedance value of the biological tissue under stimulation conditions, helping medical personnel and scientists to compare it with the impedance value of the biological tissue under normal conditions (non-stimulated or no-stimulation state), and further develop products and technologies that improve patients' quality of life and lifespan.

[0040] Fourthly, this application provides a stimulator, the stimulator comprising:

[0041] The pulse generator described in any of the third aspects;

[0042] Multiple stimulation transmission wires are connected to the pulse generator, and each stimulation transmission wire is used to transmit a stimulation pulse signal.

[0043] Multiple electrode contacts and multiple stimulation transmission wires are electrically connected in a one-to-one correspondence, and each of the electrode contacts is used to release electrical stimulation energy.

[0044] The beneficial effects of this technical solution are as follows: The stimulator is implanted in the patient's body and has a pulse generator, multiple stimulation transmission leads, and multiple electrode contacts. These electrode contacts can be located on one or more electrode leads, and the electrode leads can be located on the same side or opposite sides. For example, the two electrode leads of a deep brain stimulator can both be located in the left (hemispheric) hemisphere, both in the right (hemispheric) hemisphere, or respectively in the left and right hemispheres. This provides patients with more promising treatment prospects. For example, patients with mental illnesses such as obsessive-compulsive disorder and depression often require higher stimulation parameters (e.g., higher voltage amplitude) and longer stimulation durations. The use of multiple electrode leads is gradually becoming a trend in the field of electrical stimulation therapy and has broad application prospects. Attached Figure Description

[0045] The present application will be further described below with reference to the accompanying drawings and embodiments.

[0046] Figure 1 A schematic diagram of the structure of a stimulation chip provided in this application is shown.

[0047] Figure 2 A schematic diagram of the structure of a stimulator provided in this application is shown.

[0048] Figure 3 A schematic diagram of the specific structure of a stimulator provided in this application is shown.

[0049] Figure 4 A schematic diagram of a stacked chip structure provided in this application is shown.

[0050] Figure 5 A schematic diagram of the structure of a pulse generator provided in this application is shown.

[0051] In the diagram: 10, Pulse generator; 100, Stimulation chip; 101, Electrical interface module; 102, Pulse control module; 103, Pulse generation module; 104, Switch module; 105, Voltage measurement module; 200, Microcontroller; 300, Impedance measurement module; 400, Sampling resistor; 500, Bioelectric signal measurement module; 600, Switch chip; 700, Stacked chip; 20, Stimulation transmission wire; 30, Electrode wire; 301, Electrode contact. Detailed Implementation

[0052] The present application will now be further described in conjunction with the accompanying drawings and specific embodiments. It should be noted that, without conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments.

[0053] First, a brief description of the application areas of this application will be given.

[0054] Implantable medical devices can be any of the following: implantable neurostimulation devices, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDS), and lead adapters. 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). Stimulation (VNS), etc.; implantable medical devices are placed inside the patient's body to provide electrical stimulation. The stimulated biological tissue can be the patient's brain tissue, and the stimulated site can be a specific part of the brain tissue. Generally, the stimulated site varies depending on the type of disease the patient has. This application does not limit the types of diseases to which the implantable medical device is applicable; it can be the types of diseases applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among these, DBS can be used to treat or manage diseases. The types of illnesses include, but are 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, substance addiction, autism, or other neurological or psychiatric disorders and impairments; when DBS is used to treat patients with substance addiction, it can help drug addicts quit drugs and improve their well-being and quality of life.

[0055] See Figures 1 to 3 , Figure 1 This paper shows a schematic diagram of the structure of a stimulation chip 100 provided in this application. Figure 2 A schematic diagram of the structure of a stimulator provided in this application is shown. Figure 3 A schematic diagram of the specific structure of a stimulator provided in this application is shown. The stimulation chip 100 includes:

[0056] An electrical interface module 101 is electrically connected to a microcontroller 200. The electrical interface module 101 is used to receive and output stimulation control signals sent by the microcontroller 200.

[0057] A pulse control module 102 is electrically connected to the electrical interface module 101. The pulse control module 102 is used to receive the stimulation control signal and output the pulse control signal.

[0058] Multiple pulse generation modules 103 are provided, each of which is electrically connected to the pulse control module 102. Each pulse generation module 103 is used to receive the pulse control signal and output a stimulation pulse signal.

[0059] Multiple switch modules 104 are electrically connected to multiple pulse generation modules 103 in a one-to-one correspondence. Each switch module 104 is connected to multiple stimulation transmission wires 20 so that each stimulation transmission wire 20 is connected to one of the switch modules 104. At least one switch module 104 is used to receive the stimulation pulse signal and output it to two selected stimulation transmission wires 20, so that the two selected stimulation transmission wires 20 transmit the stimulation pulse signal to the corresponding electrode contact 301 and release electrical stimulation energy.

[0060] The voltage measurement module 105 is electrically connected to the two selected stimulation transmission wires 20 and the microcontroller 200 respectively. The voltage measurement module 105 is used to measure the voltage value between the electrode contacts 301 corresponding to the two selected stimulation transmission wires 20 and output it to the microcontroller 200.

[0061] Therefore, the electrical interface module 101 interacts with the microcontroller 200 to receive stimulation control signals and transmit them to the pulse control module 102. The pulse control module 102 outputs pulse control signals, and one or more pulse generation modules 103 (i.e., stimulation sources) generate one or more stimulation pulse signals. These stimulation pulse signals are transmitted through the switch module 104 to two selected stimulation transmission wires 20 (the stimulation pulse signals received by the two stimulation transmission wires 20 can be from the same stimulation source or different stimulation sources). The stimulation pulse signals are then transmitted through these two stimulation transmission wires 20 to the corresponding electrode contacts 301. The electrode contacts 301 release electrical stimulation energy to the surrounding body tissues to provide electrical stimulation therapy to the patient.

[0062] On the one hand, multiple pulse generation modules 103 are provided, enabling the simultaneous generation of various stimulation pulse signals with different stimulation parameters. On the other hand, a switch module 104 is provided to selectively transmit the generated stimulation pulse signals to two of the stimulation transmission leads 20, facilitating medical personnel to observe the voltage signal (voltage signal, voltage value) between specific combinations of electrode contacts 301. Furthermore, this stimulation chip 100 integrates multiple pulse generation modules 103 and multiple switch modules 104 into one unit, achieving high integration and small footprint, which is particularly beneficial for implantable medical devices. For medical products that are sensitive to size and space occupation, this can help reduce the overall size of the product and broaden its application prospects. In addition, the stimulation chip 100 and the microcontroller 200 are set up separately. The microcontroller 200 is responsible for data interaction with external devices. For example, the microcontroller 200 obtains the program control signal provided by the external programmable device through wireless communication chips such as Bluetooth chips, analyzes the stimulation parameter information therein, and outputs stimulation control signals. In this way, the stimulation chip 100 does not have direct data interaction with external devices, avoiding external electromagnetic wave interference with the output of the stimulation chip 100 and providing strong anti-interference capabilities.

[0063] The stimulation parameters in this application include, for example, voltage amplitude, voltage pulse width, and voltage frequency in constant voltage mode, and current amplitude, current pulse width, and current frequency in constant current mode.

[0064] This application does not limit the number of pulse generation module 103 and switch module 104. The number of both is generally the same, and the number can be, for example, 2, 3, 4, 5, etc.

[0065] In some alternative embodiments, at least one of the switching modules 104 is configured to receive the stimulation pulse signal, output a positive stimulation pulse signal to one of the two selected stimulation transmission wires 20, and output a negative stimulation pulse signal to the other of the two selected stimulation transmission wires 20.

[0066] Thus, one or more switching modules 104 receive stimulation pulse signals and output them to two stimulation transmission wires 20. For example, when a switching module 104 receives a stimulation pulse signal, it can selectively output a positive stimulation pulse signal or a negative stimulation pulse signal through the micro-switch between the switching module 104 and each stimulation transmission wire 20 (one flips and the other does not flip, thus obtaining the opposite stimulation pulse signal). For example, a positive stimulation pulse signal can be output to one stimulation transmission wire 20 and a negative stimulation pulse signal can be output to the other stimulation transmission wire 20.

[0067] When the two switching modules 104 receive a stimulation pulse signal, they can selectively output a positive stimulation pulse signal or a negative stimulation pulse signal through the micro-switch between each switching module 104 and its corresponding stimulation transmission wire 20 (one flips and the other does not flip, thus obtaining the opposite stimulation pulse signal). For example, a positive stimulation pulse signal can be output to one stimulation transmission wire 20 and a negative stimulation pulse signal can be output to the other stimulation transmission wire 20.

[0068] When the two switch modules 104 receive two stimulation pulse signals, if the two stimulation pulse signals are one positive and one negative, they can output one positive and one negative stimulation pulse signal to the two stimulation transmission wires 20 respectively through the micro-switch (the micro-switches corresponding to the two stimulation transmission wires 20 do not flip or both flip). If the two stimulation pulse signals are both positive or both negative, the received stimulation pulse signal can be flipped by the micro-switch corresponding to one of the stimulation transmission wires 20, thereby outputting one positive and one negative stimulation pulse signal to the two stimulation transmission wires 20 respectively.

[0069] The two selected stimulation transmission leads 20 receive positive and negative stimulation pulse signals, respectively. These two opposite stimulation pulse signals act on different tissues or neurons in the body, which facilitates the formation of a larger voltage difference between the two electrode contacts 301. This allows for more accurate acquisition of the stimulation voltage signal between the two electrode contacts 301 when the electrode contacts 301 are releasing electrical stimulation energy (stimulation state).

[0070] In some alternative implementations, the electrical interface module 101 is an SPI interface module.

[0071] Therefore, SPI stands for Serial Peripheral Interface, a synchronous serial interface technology. It is a high-speed, full-duplex, synchronous communication bus with advantages such as supporting full-duplex operation, simple operation, and high data transmission rate. Using an SPI interface module as the data interaction interface between the microcontroller and the 2000 microcontroller can provide high data transmission efficiency and support bidirectional data transmission.

[0072] See also Figure 1 and Figure 3 In some optional embodiments, the number of pulse generation modules 103 and switching modules 104 are both two.

[0073] Therefore, two pulse generation modules 103 and two switching modules 104 are set in the stimulation chip 100. If too many pulse generation modules 103 and switching modules 104 are set in the stimulation chip 100, it will lead to an increase in volume, which may be detrimental to implantation in the patient's body (it may cause inconvenience to the patient's life or cause discomfort to the patient). Therefore, two of each can be set.

[0074] In some alternative embodiments, the stimulation chip 100 is fabricated using a 0.35µm CMOS process.

[0075] Therefore, by employing precise manufacturing processes, a high-quality and stable stimulation chip 100 can be provided. Unlike external medical devices, which sometimes have lower manufacturing precision but do not affect their use, or whose malfunctions are tolerated by patients who can easily switch to other devices, implanted medical devices are different. Once implanted, these devices are generally not frequently replaced, or replacement is costly (requiring surgery to remove the old device and insert the new one). On the one hand, patients have to pay for the surgery (which is not an issue with external medical devices), and on the other hand, they have to endure significant pain (which is not an issue with external medical devices). Therefore, as part of an implantable medical device, the stimulation chip 100 itself requires higher manufacturing precision, higher quality, and better stability to avoid the need for frequent replacements.

[0076] In addition, patients with implantable medical devices are often those with Parkinson's disease, obsessive-compulsive disorder, depression, addiction, etc., who require continuous electrical stimulation therapy. When they do not receive effective stimulation therapy, patients with depression may commit suicide, and drug addicts may relapse. This is something that medical staff, patients, and society as a whole do not want to see. These characteristics determine that implantable medical devices as a whole require more technical content and higher standards of processing technology.

[0077] See Figure 4 , Figure 4 A schematic diagram of a stacked chip 700 provided in this application is shown. The stacked chip 700 includes:

[0078] At least one of the above-mentioned stimulation chips 100;

[0079] A switching chip 600 is connected to each switching module 104 of each stimulation chip 100 and each stimulation transmission wire 20 respectively;

[0080] At least one of the switch modules 104 is used to receive stimulation pulse signals and output them through the switch chip 600 to the two selected stimulation transmission wires 20.

[0081] Therefore, chip stacking technology can stack and interconnect multiple existing chips, components, packages, and even wafers to form a three-dimensional package, significantly increasing assembly density and promoting the development of implantable medical devices towards high density, high reliability, low power consumption, high speed, and miniaturization. It boasts advantages such as small size, high development efficiency, and rapid fulfillment of new product application needs. Furthermore, the process is largely compatible with traditional processes, allowing for rapid production and market entry after improvements, thus possessing broad development prospects. The stacked chip 700 prepared using chip stacking technology has one or more stimulation chips 100 and a switch chip 600. This integrates an additional switch chip 600 with the stimulation chip 100, providing the opportunity for simultaneous stimulation therapy from the pulse generation module 103 (stimulation source) of different stimulation chips 100. For example, the switch chip 600 can control one stimulation source on each of two stimulation chips 100 to simultaneously generate stimulation pulses, or even control more stimulation sources on more stimulation chips 100 to simultaneously generate stimulation pulses, thus providing broader application prospects for stimulation therapy methods.

[0082] In some alternative implementations, the number of stimulation chips 100 is greater than one;

[0083] The two selected stimulation transmission wires 20 are respectively connected to different switching modules 104, and the two switching modules 104 connected to the two selected stimulation transmission wires 20 are located in different stimulation chips 100.

[0084] Thus, the stacked chip 700 has two or more stimulation chips 100, and stimulation pulses are generated simultaneously using stimulation sources on two of the stimulation chips 100.

[0085] In some alternative implementations, the number of stimulation chips 100 is two.

[0086] Therefore, two stimulation chips 100 are set in the stacked chip 700. If there are too many stimulation chips 100 in the stacked chip 700, it will lead to an increase in volume (each stimulation chip 100 has a circuit with the switch chip 600), which may be detrimental to implantation in the patient's body (it may cause inconvenience to the patient's life or cause discomfort to the patient). Therefore, two stimulation chips 100 can be set.

[0087] See Figure 2 , Figure 3 and Figure 5 , Figure 5 A schematic diagram of the structure of a pulse generator 10 provided in this application is shown. The pulse generator 10 includes:

[0088] The microcontroller 200 is used to output stimulation control signals;

[0089] The above-mentioned stimulation chip 100 or the above-mentioned stacked chip 700;

[0090] Multiple sampling resistors 400 ( Figure 3 and Figure 5 (Only one of them is shown), each pulse generation module 103 and each switch module 104 are electrically connected one-to-one through one of the sampling resistors 400;

[0091] Multiple impedance measurement modules 300 ( Figure 3 and Figure 5 (Only one of them is shown) Each impedance measurement module 300 is electrically connected to both ends of a sampling resistor 400 and the microcontroller 200. Each impedance measurement module 300 is used to measure the voltage value across the sampling resistor 400 and output it to the microcontroller 200, so that the microcontroller 200 calculates the current value in the stimulation path formed by the two stimulation transmission wires 20 based on the voltage value across the sampling resistor 400 and the resistance value of the sampling resistor 400. The microcontroller 200 also calculates the impedance value of the biological tissue between the electrode contacts 301 corresponding to the two stimulation transmission wires 20 based on the voltage value between the electrode contacts 301 corresponding to the two stimulation transmission wires 20 and the current value in the stimulation path.

[0092] Therefore, the pulse generator 10 includes a microcontroller 200, a stimulation chip 100 or a stacked chip 700, multiple sampling resistors 400, and multiple impedance measurement modules 300. It can measure the current value in the stimulation pathway (i.e., the conductive pathway where the electrode contact 301 is located) under stimulation and calculate the impedance value of the biological tissue between the two electrode contacts 301 by combining the current value with the voltage value between the two electrode contacts 301. The impedance value calculated in this way can accurately reflect the impedance value of the biological tissue under stimulation, helping medical personnel and scientists to compare it with the impedance value of the biological tissue under normal conditions (non-stimulated or no-stimulation state), and further develop products and technologies to improve patients' quality of life and lifespan.

[0093] In some optional embodiments, the pulse generator 10 may further include a bioelectric signal measurement module 500, which is electrically connected to the two selected stimulation transmission leads 20 and the microcontroller 200, respectively. The bioelectric signal measurement module 500 is used to measure the (weak) bioelectric signal between the electrode contacts 301 corresponding to the two selected stimulation transmission leads 20 in a non-stimulated state and output it to the microcontroller 200.

[0094] In this application, the "no-stimulation state" refers to the state where the pulse generation modules 103 corresponding to the two newly selected stimulation transmission leads 20 do not generate stimulation pulse signals. That is, the time for acquiring bioelectrical signals can be the interval between two adjacent stimulation pulse signals generated by the pulse generation module 103 (when the pulse generation module 103 is in the working state), or it can be the time when the pulse generation module 103 is in the non-working state. This is because bioelectrical signals are relatively weak and not on the same order of magnitude as stimulation pulse signals. If bioelectrical signals are acquired in a stimulated state, they will not be pure (clean) bioelectrical signals but will be affected by the stimulation pulse signals.

[0095] See also Figure 2 and Figure 3 This application also provides a stimulator, the stimulator comprising:

[0096] Any of the above pulse generators 10;

[0097] Multiple stimulation transmission wires 20 are connected to the pulse generator 10, and each stimulation transmission wire 20 is used to transmit a stimulation pulse signal.

[0098] Multiple electrode contacts 301 are electrically connected one-to-one with multiple stimulation transmission wires 20, and each electrode contact 301 is used to release electrical stimulation energy.

[0099] Therefore, this stimulator, implanted in the patient's body, includes a pulse generator 10, multiple stimulation transmission leads 20, and multiple electrode contacts 301. The multiple electrode contacts 301 can be located on one or more electrode leads 30, and the multiple electrode leads 30 can be located on the same side or opposite sides. For example, the two electrode leads 30 of a deep brain stimulator can both be located in the left (hemispheric) hemisphere, both in the right (hemispheric) hemisphere, or respectively in the left and right hemispheres. This provides patients with more promising treatment prospects. For example, patients with mental illnesses such as obsessive-compulsive disorder and depression often require higher stimulation parameters (e.g., higher voltage amplitude) and longer stimulation durations. The use of multiple electrode leads 30 is gradually becoming a trend in the field of electrical stimulation therapy and has broad application prospects.

[0100] This application describes the invention from the perspectives of purpose, performance, progress, and novelty, and it meets the functional enhancement and use requirements emphasized by the Patent Law. The above description and drawings are merely preferred embodiments of this application and are not intended to limit this application. Therefore, all structures, devices, features, etc., that are similar to or identical to those of this application, i.e., all equivalent substitutions or modifications made in accordance with the scope of this patent application, shall fall within the scope of protection of this patent application.

Claims

1. A stimulation chip, characterized in that, The stimulation chip includes: An electrical interface module is electrically connected to a microcontroller. The electrical interface module is used to receive and output stimulation control signals sent by the microcontroller. A pulse control module is electrically connected to the electrical interface module. The pulse control module is used to receive the stimulation control signal and output a pulse control signal. Multiple pulse generation modules are provided, each of which is electrically connected to the pulse control module. Each pulse generation module is used to receive the pulse control signal and output a stimulation pulse signal. Multiple switching modules and multiple pulse generation modules are electrically connected in a one-to-one correspondence. Each switching module is connected to multiple stimulation transmission wires so that each stimulation transmission wire is connected to one of the switching modules. At least one switching module is used to receive the stimulation pulse signal and output it to two selected stimulation transmission wires so that the two selected stimulation transmission wires transmit the stimulation pulse signal to the corresponding electrode contacts and release electrical stimulation energy. A voltage measurement module is electrically connected to the two selected stimulus transmission wires and the microcontroller, respectively. The voltage measurement module is used to measure the voltage value between the electrode contacts corresponding to the two selected stimulus transmission wires and output it to the microcontroller.

2. The stimulation chip according to claim 1, characterized in that, At least one of the switching modules is configured to receive the stimulation pulse signal, output a positive stimulation pulse signal to one of the two selected stimulation transmission wires, and output a negative stimulation pulse signal to the other of the two selected stimulation transmission wires. Specifically, positive or negative stimulation pulse signals are selectively output through a micro-switch between the switching module and each stimulation transmission wire.

3. The stimulation chip according to claim 1, characterized in that, The electrical interface module is an SPI interface module.

4. The stimulation chip according to claim 1, characterized in that, The number of pulse generation modules and the number of switching modules are both two.

5. The stimulation chip according to claim 1, characterized in that, The stimulation chip was fabricated using a 0.35µm CMOS process.

6. A stacked chip, characterized in that, The stacked chips include: At least one stimulation chip according to any one of claims 1-5; A switching chip, wherein the switching chip is respectively connected to each switching module of each of the stimulation chips and each stimulation delivery wire; At least one of the switching modules is used to receive stimulation pulse signals and output them through the switching chip to two selected stimulation delivery wires.

7. The stacked chip according to claim 6, characterized in that, The number of stimulation chips is greater than one; The two selected stimulation delivery wires are respectively connected to different switching modules, and the two switching modules connected to the two selected stimulation delivery wires are located in different stimulation chips.

8. The stacked chip according to claim 7, characterized in that, The number of stimulation chips is two.

9. A pulse generator, characterized in that, The pulse generator includes: A microcontroller, wherein the microcontroller is used to output stimulation control signals; The stimulation chip according to any one of claims 1-5 or the stacked chip according to any one of claims 6-8; Multiple sampling resistors are provided, and each pulse generation module and each switching module are electrically connected in a one-to-one correspondence through one of the sampling resistors; Multiple impedance measurement modules are provided, each of which is electrically connected to both ends of a sampling resistor and a microcontroller. Each impedance measurement module measures the voltage across the sampling resistor and outputs it to the microcontroller, so that the microcontroller can calculate the current value in the stimulation path formed by the two stimulation transmission leads based on the voltage value across the sampling resistor and the resistance value of the sampling resistor, and calculate the impedance value of the biological tissue between the electrode contacts corresponding to the two stimulation transmission leads based on the voltage value between the electrode contacts corresponding to the two stimulation transmission leads and the current value in the stimulation path.

10. A stimulator, characterized in that, The stimulator includes: The pulse generator as described in claim 9; Multiple stimulation transmission wires are connected to the pulse generator, and each stimulation transmission wire is used to transmit a stimulation pulse signal. Multiple electrode contacts and multiple stimulation transmission wires are electrically connected in a one-to-one correspondence, and each of the electrode contacts is used to release electrical stimulation energy.

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