技术领域Technical Field
本发明属于植入式医疗仪器技术领域，涉及一种无源、具有负反馈调整刺激电流功能的植入式电刺激仪器。The invention belongs to the technical field of implantable medical instruments, and relates to a passive implantable electrical stimulation instrument with a negative feedback function for adjusting stimulation current.
背景技术Background technique
植入式医疗设备是一种被设计用于植入患者体内的医疗设备，由体内电刺激器和体外控制器组成，两者通过双向无线通信交换消息。植入式医疗设备通常由电池、电路板、传感器和芯片等元件构成，植入式医疗设备依靠预定的程序和参数实现不同的疗法。将植入式医疗设备应用于骨修复治疗中是未来发展的一个重要方向。骨是人体最重要的器官之一，在各种人体器官移植数量中高居第二，运动损伤、先天变形、炎症性关节炎、骨坏死、肿瘤以及感染等都有可能引发骨缺损，尽管对骨损伤的治疗效果随着骨再生医学的发展有了显著提升，但仍然有部分骨损伤难以使用常规医疗方法治愈，尤其是针对骨延迟愈合或不愈合问题。电刺激是促进骨生长修复的有效方法，通过长期植入的电极和可植入的电流发生器将电流输送到骨修复部位来实现。在现有技术中，植入式电刺激医疗设备通常采用高能量密度的锂原电池进行供电，如锂-亚硫酸氯电池和锂-多氟化碳电池等，寿命大多较短。电池的容量是限制植入式电刺激医疗设备的主要因素，一旦电池电量耗尽，患者就不得不进行二次手术，更换植入式电刺激医疗设备的内置电池，这不仅造成了患者身体上的创伤，也为患者带来了巨大的经济压力。此外，在长期植入的情况下，电池的存在对患者身体是一个极大的安全隐患。近年来，随着无线能量传输技术的发展，开发寿命更长、使用更安全的植入式电刺激医疗设备已经成为未来发展的趋势。此外，目前的植入式骨修复电刺激设备还存在输出电流无法根据输出阻抗进行自适应调整，进而造成理论刺激电流与实际刺激电流存在偏差的问题。An implantable medical device is a medical device designed to be implanted in a patient's body. It consists of an in-body electrical stimulator and an external controller, which exchange messages through two-way wireless communication. Implantable medical devices are usually composed of components such as batteries, circuit boards, sensors and chips. Implantable medical devices rely on predetermined programs and parameters to achieve different therapies. Applying implantable medical devices to bone repair treatment is an important direction for future development. Bone is one of the most important organs in the human body and ranks second in the number of human organ transplants. Sports injuries, congenital deformities, inflammatory arthritis, osteonecrosis, tumors and infections may all cause bone defects. Although the treatment effect of bone injuries has been significantly improved with the development of bone regenerative medicine, some bone injuries are still difficult to cure using conventional medical methods, especially for delayed bone healing or non-healing problems. Electrical stimulation is an effective method to promote bone growth and repair. It is achieved by delivering current to the bone repair site through long-term implanted electrodes and implantable current generators. In the prior art, implantable electrical stimulation medical devices are usually powered by high-energy-density lithium primary batteries, such as lithium-sulfite chloride batteries and lithium-polyfluorinated carbon batteries, which mostly have a short lifespan. The capacity of the battery is the main factor limiting implantable electrical stimulation medical devices. Once the battery is exhausted, the patient has to undergo a secondary operation to replace the built-in battery of the implantable electrical stimulation medical device, which not only causes physical trauma to the patient, but also brings huge economic pressure to the patient. In addition, in the case of long-term implantation, the presence of the battery is a huge safety hazard to the patient's body. In recent years, with the development of wireless energy transmission technology, the development of implantable electrical stimulation medical devices with longer life and safer use has become a future development trend. In addition, the current implantable bone repair electrical stimulation devices also have the problem that the output current cannot be adaptively adjusted according to the output impedance, which causes a deviation between the theoretical stimulation current and the actual stimulation current.
为了解决上述问题，可通过采用经皮无线传输电能的方式为植入式电刺激医疗设备的体内植入部分提供电能，该充电方式基于电磁耦合原理，利用电磁波穿透人体组织向植入式医疗设备的体内植入部分传递能量，通过调节发射能量的频率实现无线电能传输的效率优化，降低因电能传输效率低下造成的体内植入式医疗仪器的发热。通过对刺激环路中电信号的采样和滤波计算出当前刺激强度，进而通过调控算法对输出进行负反馈调节，最大程度的保证施加在生物组织上的电信号强度的精确性。In order to solve the above problems, the implantable part of the implantable electrical stimulation medical device can be provided with electrical energy by using the method of wireless transmission of electrical energy through the skin. This charging method is based on the principle of electromagnetic coupling, and uses electromagnetic waves to penetrate human tissue to transfer energy to the implantable part of the implantable medical device. By adjusting the frequency of the transmitted energy, the efficiency of wireless power transmission is optimized, and the heating of the implantable medical device in the body caused by the low efficiency of power transmission is reduced. The current stimulation intensity is calculated by sampling and filtering the electrical signal in the stimulation loop, and then the output is negatively feedback adjusted through the control algorithm to ensure the accuracy of the electrical signal intensity applied to the biological tissue to the greatest extent.
发明内容Summary of the invention
有鉴于此，本发明的目的之一在于提供一种无源、具有负反馈调整刺激电流功能的植入式电刺激仪器；本发明的目的之二在于提供一种无源、具有负反馈调整刺激电流功能的植入式电刺激仪器的控制方法。In view of this, one of the objects of the present invention is to provide a passive implantable electrical stimulation device with negative feedback adjustment of stimulation current function; the second object of the present invention is to provide a control method for a passive implantable electrical stimulation device with negative feedback adjustment of stimulation current function.
为达到上述目的，本发明提供如下技术方案：In order to achieve the above object, the present invention provides the following technical solutions:
1、一种无源、具有负反馈调整刺激电流功能的植入式电刺激仪器，所述植入式电刺激仪器包括体内电刺激器和体外控制器；1. A passive implantable electrical stimulation device with negative feedback function for adjusting stimulation current, the implantable electrical stimulation device comprising an in-vivo electrical stimulator and an in-vitro controller;
所述体内电刺激器通过其接收感应耦合线圈与体外控制器的发射感应耦合线圈之间的电磁耦合获取电能；The in-vivo electrical stimulator obtains electrical energy through electromagnetic coupling between its receiving inductive coupling coil and the transmitting inductive coupling coil of the in-vivo controller;
所述体外控制器包括体外电源模块和分别通过电源线与体外电源模块相连的体外微处理器、体外蓝牙通讯模块、体外电流监测模块、按键模块、显示模块、无线供电发射模块，其中所述无线供电发射模块中含有发射感应耦合输电线圈；The in vitro controller includes an in vitro power module and an in vitro microprocessor, an in vitro Bluetooth communication module, an in vitro current monitoring module, a key module, a display module, and a wireless power transmission module, each of which is connected to the in vitro power module through a power line. The wireless power transmission module includes a transmitting inductive coupling transmission coil.
所述体内电刺激器包括体内电源模块和分别通过电源线与体内电源模块相连的体内微处理器、体内蓝牙通讯模块、体内电流监测模块、刺激脉冲发生模块、无线供电接收模块，其中所述无线供电接收模块中含有接收感应耦合输电线圈；The in-vivo electrical stimulator comprises an in-vivo power module and an in-vivo microprocessor, an in-vivo Bluetooth communication module, an in-vivo current monitoring module, a stimulation pulse generating module, and a wireless power receiving module, each of which is connected to the in-vivo power module via a power line. The wireless power receiving module comprises a receiving inductively coupled power transmission coil.
所述体内电刺激器中不存在储能元件，只通过体内电刺激器的接收感应耦合线圈与体外控制器的发射感应耦合线圈之间的电磁耦合获取电能。There is no energy storage element in the in-vivo electrical stimulator, and electrical energy is obtained only through electromagnetic coupling between the receiving inductive coupling coil of the in-vivo electrical stimulator and the transmitting inductive coupling coil of the in-vivo controller.
优选的，所述体外微处理器为具有IIC、Usart和SPI外设的微处理器，所述体外微处理器为STM32F103C8T6微处理器；Preferably, the in vitro microprocessor is a microprocessor having IIC, Usart and SPI peripherals, and the in vitro microprocessor is a STM32F103C8T6 microprocessor;
所述体外电源模块包括锂电池以及与其连接的充电电路、升压电路以及降压稳压电路，所述体外电源模块的输出端与体外微处理器、体外蓝牙通讯模块以及体外电流监测模块相连；The external power supply module includes a lithium battery and a charging circuit, a boost circuit and a step-down voltage stabilizing circuit connected thereto, and the output end of the external power supply module is connected to an external microprocessor, an external Bluetooth communication module and an external current monitoring module;
所述显示模块为有机发光半导体屏幕；The display module is an organic light-emitting semiconductor screen;
所述按键模块包括增加键、减少键、换页键、换行键以及所述无线供电发射模块的无线供电开关键；The key module includes an increase key, a decrease key, a page change key, a line feed key and a wireless power switch key of the wireless power transmission module;
所述无线供电发射模块还包括磁耦合无线电能发射器和数字电阻。The wireless power transmission module also includes a magnetically coupled wireless power transmitter and a digital resistor.
优选的，所述体内处理器为具有ADC、DAC和Usart外设的微处理器，所述体内处理器为STM32L052C8T6微处理器；Preferably, the in vivo processor is a microprocessor having ADC, DAC and Usart peripherals, and the in vivo processor is a STM32L052C8T6 microprocessor;
所述体内电源模块包括滤波电路、降压稳压电路和电压反相电路，所述电压反相电路的输入端与降压稳压电路连接，所述电压反相电路的输出与刺激脉冲发生模块的电源负极输入连接；The in-vivo power supply module comprises a filtering circuit, a step-down voltage stabilizing circuit and a voltage inverting circuit, the input end of the voltage inverting circuit is connected to the step-down voltage stabilizing circuit, and the output of the voltage inverting circuit is connected to the negative input of the power supply of the stimulation pulse generating module;
所述无线供电接收模块还包括倍压整流电路和接收端隔磁片；The wireless power supply receiving module also includes a voltage doubling rectifier circuit and a receiving end magnetic isolation sheet;
所述体内蓝牙模块无线连接体外蓝牙模块，并以体外蓝牙模块作为主机，向体内微处理器传输控制指令；The in-vivo Bluetooth module is wirelessly connected to the in-vivo Bluetooth module, and the in-vivo Bluetooth module is used as a host to transmit control instructions to the in-vivo microprocessor;
所述刺激脉冲发生模块包括DAC转换器、与DAC转换器连接的仪表放大电路、与仪表放大电路连接的精密运放电路，所述的DAC转换器为体内微处理器内部外设。The stimulation pulse generation module includes a DAC converter, an instrument amplifier circuit connected to the DAC converter, and a precision operational amplifier circuit connected to the instrument amplifier circuit. The DAC converter is an internal peripheral of an in-vivo microprocessor.
优选的，所述发射感应耦合输电线圈和接收感应耦合输电线圈均为一个或多个线圈。Preferably, the transmitting inductively coupled power transmission coil and the receiving inductively coupled power transmission coil are both one or more coils.
优选的，所述体外控制器和体内电刺激器通过蓝牙进行通信。Preferably, the external controller and the internal electrical stimulator communicate via Bluetooth.
优选的，所述体内电刺激器被具有生物相容性的材料包裹，所述具有生物相容性的材料包括医用硅脂或聚二甲基硅氧烷材料。Preferably, the in vivo electrical stimulator is wrapped by a biocompatible material, and the biocompatible material includes medical silicone grease or polydimethylsiloxane material.
进一步优选的，所述体内电刺激器的实体为电路板，其中所述电路板与接收感应耦合输电线圈、隔磁片形成三层结构，其中所述接收感应耦合输电线圈下方依次设置有接收隔磁片和电路板。Further preferably, the entity of the in vivo electrical stimulator is a circuit board, wherein the circuit board, the receiving inductively coupled power transmission coil and the magnetic isolation sheet form a three-layer structure, wherein the receiving magnetic isolation sheet and the circuit board are sequentially arranged below the receiving inductively coupled power transmission coil.
2.上述植入式电刺激仪器的控制方法，所述控制方法是通过体外微处理器和体内微处理器的控制来进行；2. A control method for the implantable electrical stimulation device, wherein the control method is performed by controlling an external microprocessor and an internal microprocessor;
所述体外微处理器通过外部中断服务子程序处理按键状态，所述体外微处理器每检测到按键按下产生一次外部中断，根据按下按键的不同调整参数并将参数展示在显示模块上，所述参数包括刺激电流大小、模式选择、刺激频率、刺激时间、通信连接状态、无线供电状态、刺激开/关状态；The external microprocessor processes the key status through an external interrupt service subroutine. The external microprocessor generates an external interrupt each time it detects that a key is pressed, adjusts parameters according to the key pressed, and displays the parameters on the display module. The parameters include stimulation current size, mode selection, stimulation frequency, stimulation time, communication connection status, wireless power supply status, and stimulation on/off status;
所述体内微处理器通过串口中断服务子程序接收来自体外处理器发送的数据，体内微处理器的接收寄存器收到一个字符的数据产生一次串口中断，将数据读取到体内微处理器中，其中所述数据包括刺激电流大小、模式、刺激频率、电刺激开/关指令。The in-vivo microprocessor receives data sent from the in-vivo processor through a serial port interrupt service subroutine. When the receiving register of the in-vivo microprocessor receives one character of data, a serial port interrupt is generated, and the data is read into the in-vivo microprocessor, wherein the data includes stimulation current size, mode, stimulation frequency, and electrical stimulation on/off instructions.
进一步优选的，当无线供电开启后，体外蓝牙模块自动搜索体内蓝牙信号建立连接，将控制指令传输至体内电刺激器，然后通过串口中断服务子程序接收来自体内微处理器发送的数据，处理后展示在显示模块上；Further preferably, when the wireless power supply is turned on, the external Bluetooth module automatically searches for the internal Bluetooth signal to establish a connection, transmits the control instruction to the internal electrical stimulator, and then receives the data sent from the internal microprocessor through the serial port interrupt service subroutine, and displays it on the display module after processing;
体内微处理器接收到指令数据后，选择相应的输出模式、计算输出电平的大小输出相应刺激信号，并调用反馈调整算法对输出进行调整。After receiving the instruction data, the microprocessor in the body selects the corresponding output mode, calculates the output level, outputs the corresponding stimulation signal, and calls the feedback adjustment algorithm to adjust the output.
优选的，所述体外微处理器检测到无线供电发射模块的无线供电状态为开启后，体外蓝牙通讯模块自动搜索体内蓝牙信号并建立连接，所述体外微处理器检测到蓝牙通讯连接后，体外微处理器通过串口将控制指令经体外蓝牙通讯模块发送至体内电刺激器；Preferably, after the external microprocessor detects that the wireless power supply state of the wireless power supply transmitting module is turned on, the external Bluetooth communication module automatically searches for the internal Bluetooth signal and establishes a connection. After the external microprocessor detects the Bluetooth communication connection, the external microprocessor sends the control instruction to the internal electrical stimulator through the external Bluetooth communication module via the serial port;
所述体外微处理器通过串口中断服务子程序接收来自体内微处理器发送的数据，体外微处理器的接收寄存器收到一个字符的数据产生一次串口中断，将数据读取到体外微处理器中并将其展示在显示模块，所述数据为采样的刺激电流大小。The external microprocessor receives data sent from the internal microprocessor through the serial port interrupt service subroutine. The receiving register of the external microprocessor generates a serial port interrupt when it receives a character of data, reads the data into the external microprocessor and displays it on the display module. The data is the sampled stimulation current size.
优选的，在所述体内电源模块接收的能量满足到所述体内电刺激器所需的功率时，体内微处理器开始工作；Preferably, when the energy received by the in-vivo power module meets the power required by the in-vivo electrical stimulator, the in-vivo microprocessor starts to work;
所述体内微处理器根据串口中断接收到的指令选择输出模式、计算输出电平的大小输出相应刺激信号，并调用负反馈调整算法对输出进行调整。The in-vivo microprocessor selects an output mode according to the instruction received by the serial port interrupt, calculates the output level, outputs a corresponding stimulation signal, and calls a negative feedback adjustment algorithm to adjust the output.
本发明的有益效果在于：本发明公开了一种无源、具有负反馈调整刺激电流功能的植入式电刺激仪器，主要是包括含有接收感应耦合输电线圈的体内电刺激器和含有发射感应耦合输电线圈的体外控制器，故本发明的植入式电刺激仪器不需要将电池植入体内，而是通过耦合输电线圈的感应耦合传输的能量进行实时供给，从而使得植入式电刺激仪器具有体积小、重量轻的特点；同时通过体外蓝牙通讯模块和体内蓝牙通讯模块实现体外控制器和体内电刺激器的通讯，通过体外控制器进行参数的设置、指令的控制、电磁耦合频率的调整以及体内刺激电流的实时显示，使用方便；另外体内微处理器利用调控算法实现刺激电信号精确输出，通过对电刺激实时电信号的采集滤波，进而调节输出强度，避免了盲目刺激，可提供准确的电刺激输出强度。The beneficial effects of the present invention are as follows: the present invention discloses a passive implantable electrical stimulation instrument with a negative feedback adjustment stimulation current function, which mainly includes an in-vivo electrical stimulator containing a receiving inductively coupled power transmission coil and an in-vivo controller containing a transmitting inductively coupled power transmission coil. Therefore, the implantable electrical stimulation instrument of the present invention does not need to implant a battery into the body, but is supplied in real time by the energy transmitted by the inductive coupling of the coupled power transmission coil, so that the implantable electrical stimulation instrument has the characteristics of small size and light weight; at the same time, the communication between the in-vivo controller and the in-vivo electrical stimulator is realized through the in-vivo Bluetooth communication module and the in-vivo Bluetooth communication module, and the parameters are set, the instructions are controlled, the electromagnetic coupling frequency is adjusted, and the in-vivo stimulation current is displayed in real time through the in-vivo controller, which is convenient to use; in addition, the in-vivo microprocessor uses a control algorithm to realize the precise output of the stimulation electrical signal, and the output intensity is adjusted by collecting and filtering the real-time electrical signal of the electrical stimulation, thereby avoiding blind stimulation and providing accurate electrical stimulation output intensity.
本发明的其他优点、目标和特征在某种程度上将在随后的说明书中进行阐述，并且在某种程度上，基于对下文的考察研究对本领域技术人员而言将是显而易见的，或者可以从本发明的实践中得到教导。本发明的目标和其他优点可以通过下面的说明书来实现和获得。Other advantages, objectives and features of the present invention will be described in the following description to some extent, and to some extent, will be obvious to those skilled in the art based on the following examination and study, or can be taught from the practice of the present invention. The objectives and other advantages of the present invention can be realized and obtained through the following description.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为了使本发明的目的、技术方案和优点更加清楚，下面将结合附图对本发明作优选的详细描述，其中：In order to make the purpose, technical solutions and advantages of the present invention more clear, the present invention will be described in detail below in conjunction with the accompanying drawings, wherein:
图1为实施例1中植入式电刺激仪器的安装示意图；FIG1 is a schematic diagram of the installation of an implantable electrical stimulation device in Example 1;
图2为实施例1中植入式电刺激仪器的系统结构示意图；FIG2 is a schematic diagram of the system structure of the implantable electrical stimulation device in Example 1;
图3为实施例1中植入式电刺激仪器的体外微处理器工作电路原理示意图；FIG3 is a schematic diagram of the working circuit principle of the in vitro microprocessor of the implantable electrical stimulation instrument in Example 1;
图4为实施例1中FS5080高效率充电器芯片的工作电路原理示意图；FIG4 is a schematic diagram of the working circuit principle of the FS5080 high-efficiency charger chip in Example 1;
图5为实施例1中PW5300A升压芯片的工作电路原理示意图；FIG5 is a schematic diagram of the working circuit principle of the PW5300A boost chip in Example 1;
图6为实施例1中ME6211降压稳压芯片的工作电路示意图；FIG6 is a schematic diagram of the working circuit of the ME6211 step-down voltage regulator chip in Example 1;
图7为实施例1中INA219体外电流监测模块的工作电路原理示意图；FIG7 is a schematic diagram of the working circuit principle of the INA219 in vitro current monitoring module in Example 1;
图8为实施例1中AD5160BRJZ100数字电阻的工作电路原理示意图；FIG8 is a schematic diagram of the working circuit principle of the AD5160BRJZ100 digital resistor in Example 1;
图9为实施例1中STM32L052C8T6微处理器的工作电路原理示意图；FIG9 is a schematic diagram of the working circuit principle of the STM32L052C8T6 microprocessor in Example 1;
图10为实施例1中STM32L052C8T6微处理器的硬件连接图；FIG10 is a hardware connection diagram of the STM32L052C8T6 microprocessor in Example 1;
图11为实施例1中LMR16006XDDCR高效降压稳压芯片的工作电路原理示意图；FIG11 is a schematic diagram of the working circuit principle of the LMR16006XDDCR high-efficiency buck-stabilizing chip in Example 1;
图12为实施例1中LTC1983-5芯片的工作电路原理示意图；FIG12 is a schematic diagram of the working circuit principle of the LTC1983-5 chip in Example 1;
图13为实施例1中电刺激输出电路的原理示意图；FIG13 is a schematic diagram of the principle of the electrical stimulation output circuit in Example 1;
图14为实施例1中INA186体内电流监测模块的工作电路原理示意图；FIG14 is a schematic diagram showing the working circuit principle of the INA186 in vivo current monitoring module in Example 1;
图15为实施例2中体外控制器的主程序控制流程示意图；FIG15 is a schematic diagram of the main program control flow of the in vitro controller in Example 2;
图16为实施例2中体内电刺激器的主程序控制流程示意图；FIG16 is a schematic diagram of the main program control flow of the in vivo electrical stimulator in Example 2;
图17为实施例2中负反馈调控算法流程图。FIG17 is a flow chart of the negative feedback control algorithm in Example 2.
具体实施方式Detailed ways
以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。需要说明的是，以下实施例中所提供的图示仅以示意方式说明本发明的基本构想，在不冲突的情况下，以下实施例及实施例中的特征可以相互组合。The following describes the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the following embodiments only illustrate the basic concept of the present invention in a schematic manner, and the following embodiments and the features in the embodiments can be combined with each other without conflict.
实施例1Example 1
一种无源、具有负反馈调整刺激电流功能的植入式电刺激仪器，其安装示意图如图1所示，该植入式电刺激仪器的系统结构示意图如图2所示，由体内电刺激器和体外控制器组成，其中：A passive implantable electrical stimulation device with negative feedback adjustment function for stimulation current, the installation diagram of which is shown in FIG1 , and the system structure diagram of the implantable electrical stimulation device is shown in FIG2 , which is composed of an in-vivo electrical stimulator and an in-vitro controller, wherein:
体外控制器置于人体外部，包括体外微处理器、体外蓝牙通讯模块、体外电流监测模块、体外电源模块、按键模块、显示模块以及无线供电发射模块；体内植入部分置于人体内部，包括体内微处理器、体内蓝牙通讯模块、体内电源模块、体内电流监测模块、刺激脉冲发生模块以及无线供电接收模块。The external controller is placed outside the human body, including an external microprocessor, an external Bluetooth communication module, an external current monitoring module, an external power supply module, a button module, a display module and a wireless power transmission module; the in vivo implantable part is placed inside the human body, including an in vivo microprocessor, an in vivo Bluetooth communication module, an in vivo power supply module, an in vivo current monitoring module, a stimulation pulse generating module and a wireless power receiving module.
上述体外控制器中的体外微处理器为STM32 F103C8T6微处理器(工作电路示意图如图3所示)，是一款32位处理器，CPU工作频率为72MHz，外设丰富，满足装置需要的定时器、ADC、I2C、SPI、GPIO和USART功能模块，其中I2C外设模块用于设置OLED屏幕，SPI外设模块用于与数字电位器通讯。The in vitro microprocessor in the above-mentioned in vitro controller is an STM32 F103C8T6 microprocessor (the schematic diagram of the working circuit is shown in Figure 3), which is a 32-bit processor with a CPU operating frequency of 72MHz and rich peripherals, including timer, ADC, I2C, SPI, GPIO and USART functional modules that meet the needs of the device. Among them, the I2C peripheral module is used to set the OLED screen, and the SPI peripheral module is used to communicate with the digital potentiometer.
上述体外电源模块包括两节4.2V锂电池以及与其连接的充电电路(采用FS5080高效率充电器芯片，电池电压经过升压电路、降压稳压电路后供体外微处理器工作，充电电路如图4所示)、升压电路(采用PW5300A升压芯片将电池电压升至9V供无线供电发射模块使用，电路示意图如图5所示)以及降压稳压电路(采用ME6211降压稳压芯片，电路示意图如图6所示)。体外控制设备通过USB线连接充电电路对电池充电。The above-mentioned external power supply module includes two 4.2V lithium batteries and a charging circuit connected thereto (using the FS5080 high-efficiency charger chip, the battery voltage is supplied to the external microprocessor after passing through the boost circuit and the buck regulator circuit, the charging circuit is shown in Figure 4), a boost circuit (using the PW5300A boost chip to increase the battery voltage to 9V for the wireless power transmission module, the circuit diagram is shown in Figure 5) and a buck regulator circuit (using the ME6211 buck regulator chip, the circuit diagram is shown in Figure 6). The external control device is connected to the charging circuit via a USB cable to charge the battery.
上述体外电流监测模块选用INA219作为采集无线供电发射模块电流信号的传感器，其工作电路示意图如图7所示。The above-mentioned extracorporeal current monitoring module uses INA219 as a sensor for collecting the current signal of the wireless power transmission module, and its working circuit diagram is shown in Figure 7.
上述显示模块为有机发光半导体屏幕(organic electroluminescence display，OLED)。The display module is an organic electroluminescence display (OLED).
上述体外蓝牙通讯模块采用的是BT-11型主从一体蓝牙串口模块，其体积小巧，稳定性高，可用于与上位机实现数据的透传。本装置采用体外配套设备作为上位机。通过BT-11和STM32自带的USART接口实现通讯，通讯波特率为115200kb/s。在AT模式下，可对BT-11进行参数设置，包括波特率、名称和主从模式等。其RX和TX引脚分别连接体外微处理器USART的TX和RX引脚实现数据的相互传输。The above-mentioned in vitro Bluetooth communication module adopts the BT-11 master-slave integrated Bluetooth serial port module, which is small in size and highly stable, and can be used to realize data transparent transmission with the host computer. This device uses an in vitro supporting device as the host computer. Communication is realized through the USART interface of BT-11 and STM32, and the communication baud rate is 115200kb/s. In AT mode, the parameters of BT-11 can be set, including baud rate, name, master-slave mode, etc. Its RX and TX pins are respectively connected to the TX and RX pins of the in vitro microprocessor USART to realize mutual transmission of data.
上述按键模块包括增加键、减少键、换页键、换行键以及无线供电开关键；The key module includes an increase key, a decrease key, a page change key, a line feed key and a wireless power switch key;
上述无线供电发射模块包括发射感应耦合输电线圈、发射端隔磁片、磁共振耦合无线电能发射器和数字电阻，通过调节数字电阻的阻值设定不同的无线供电发射模块供电传输频率。数字电阻采用AD5160BRJZ100，其电路示意图如图8所示。The wireless power transmission module includes a transmitting inductive coupling transmission coil, a transmitting end magnetic isolation sheet, a magnetic resonance coupling wireless power transmitter and a digital resistor. Different wireless power transmission frequencies are set by adjusting the resistance of the digital resistor. The digital resistor uses AD5160BRJZ100, and its circuit diagram is shown in Figure 8.
上述体内微处理器为STM32L052C8T6微处理器(工作电路示意图如图9所示，硬件连接图如图10所示)，是一款超低功耗32位处理器，CPU工作频率为72MHz，提供多种模拟功能，一个带硬件过采样的12位ADC、一个DAC、几个定时器、一个低功耗定时器，支持1.8～3.3V的工作电源，其中ADC外设模块用于采集电流监测模块电压，DAC外设模块用于控制刺激电流输出。The above-mentioned in vivo microprocessor is an STM32L052C8T6 microprocessor (the schematic diagram of the working circuit is shown in Figure 9, and the hardware connection diagram is shown in Figure 10), which is an ultra-low power 32-bit processor with a CPU operating frequency of 72MHz. It provides multiple analog functions, a 12-bit ADC with hardware oversampling, a DAC, several timers, and a low-power timer, and supports a working power supply of 1.8 to 3.3V. The ADC peripheral module is used to collect the voltage of the current monitoring module, and the DAC peripheral module is used to control the stimulation current output.
上述体内电源模块包括滤波电路、降压稳压电路(采用LMR16006XDDCR高效降压稳压芯片，通过对无线接收模块输出的电压进行降压稳压后供后续电路使用，其电路示意图如图11所示)和电压反相电路(采用LTC1983-5芯片搭建，将降压稳压电路输出电压转换为反相电压，供刺激脉冲发生模块使用，其电路示意图如图12所示)。The above-mentioned in vivo power supply module includes a filtering circuit, a buck-stabilizing circuit (using the LMR16006XDDCR high-efficiency buck-stabilizing chip, which steps down and stabilizes the voltage output by the wireless receiving module for use by subsequent circuits, and its circuit diagram is shown in Figure 11) and a voltage inversion circuit (built with the LTC1983-5 chip, which converts the output voltage of the buck-stabilizing circuit into an inverting voltage for use by the stimulation pulse generating module, and its circuit diagram is shown in Figure 12).
上述无线接收模块包括倍压整流电路、接收感应耦合输电线圈和接收端隔磁片。The wireless receiving module comprises a voltage doubling rectifier circuit, a receiving inductive coupling transmission coil and a receiving end magnetic isolation sheet.
上述体内蓝牙通讯模块所选型号与体外蓝牙通讯模块相同，体内蓝牙通讯模块与体外蓝牙通讯模块无线连接，并以体外蓝牙通讯模块作为主机，向体内微处理器传输控制指令。The model selected for the above-mentioned in-vivo Bluetooth communication module is the same as that of the in-vivo Bluetooth communication module. The in-vivo Bluetooth communication module is wirelessly connected to the in-vivo Bluetooth communication module, and the in-vivo Bluetooth communication module is used as a host to transmit control instructions to the in-vivo microprocessor.
上述刺激脉冲发生模块包括DAC转换器(DAC转换器为体内处理器内部外设)、与DAC转换器连接的仪表放大电路、与仪表放大电路连接的精密运放电路。体内微处理器通过控制DAC转换器输出进而控制电刺激模块输出相应电信号。电刺激输出电路采用INA826AIDRGR和TLV9061IDBVR芯片搭建，其电路示意图如图13所示。The stimulation pulse generation module includes a DAC converter (the DAC converter is an internal peripheral of the in-vivo processor), an instrument amplifier circuit connected to the DAC converter, and a precision operational amplifier circuit connected to the instrument amplifier circuit. The in-vivo microprocessor controls the output of the DAC converter to control the electrical stimulation module to output the corresponding electrical signal. The electrical stimulation output circuit is constructed using INA826AIDRGR and TLV9061IDBVR chips, and its circuit diagram is shown in Figure 13.
体内电流监测模块选用INA186作为体内配套设备采集电刺激输出电流信号的传感器，其工作电路示意图如图14所示。The in-vivo current monitoring module uses INA186 as the sensor for collecting the output current signal of electrical stimulation from the in-vivo supporting equipment. The schematic diagram of its working circuit is shown in FIG14 .
实施例2Example 2
上述实施例1中植入式电刺激仪器的软件控制方法，具体如下所示：The software control method of the implantable electrical stimulation device in the above-mentioned embodiment 1 is specifically as follows:
1、体外控制器的软件控制方法1. Software control method of in vitro controller
体外控制器的STM32微处理器通过外部中断服务子程序检测外部按键，通过不同的按键组合进行电刺激参数的设置，并同步显示在显示模块上(其中电刺激参数包括刺激电流大小、模式、刺激频率、无线供电发射模块的开关状态、刺激时间、电刺激开关状态)，参数设置完毕后通过按键将指令通过蓝牙模块发送至体内装置。The STM32 microprocessor of the in vitro controller detects external buttons through an external interrupt service subroutine, sets the electrical stimulation parameters through different button combinations, and displays them synchronously on the display module (where the electrical stimulation parameters include stimulation current size, mode, stimulation frequency, switch status of the wireless power supply transmission module, stimulation time, and electrical stimulation switch status). After the parameters are set, the instructions are sent to the in vivo device through the Bluetooth module by pressing buttons.
体外控制器的主程序控制流程图如图15所示，具体步骤如下：The main program control flow chart of the in vitro controller is shown in Figure 15, and the specific steps are as follows:
第一步，当检测到按键按下时，记录当前按键的标志，开启定时器计时，当计时结束后，重新检测按键并对比标志是否相同，如果不相同，则认为是误触，清空记录的标志，重新检测，直到检测到两次相同的按键标志，才执行后续步骤；The first step is to record the sign of the current key when a key is detected to be pressed, start the timer, and when the time is up, re-detect the key and compare whether the sign is the same. If it is not the same, it is considered to be a false touch, clear the recorded sign, and re-detect until the same key sign is detected twice, then execute the subsequent steps;
第二步，通过按下相应按键开启无线供电发射模块，向体内电刺激器传输能量同时将能量传输开启状态图案展示在显示模块，同时使能电流监测，采集发射电流，将发射电流的大小展示在显示模块并通过按键，将发射电流的大小调整到合适值，以提高电刺激耦合效率；The second step is to turn on the wireless power transmission module by pressing the corresponding button, transmit energy to the in-vivo electrical stimulator, and display the energy transmission on-state pattern on the display module. At the same time, current monitoring is enabled, the transmission current is collected, the magnitude of the transmission current is displayed on the display module, and the magnitude of the transmission current is adjusted to a suitable value by pressing the button to improve the electrical stimulation coupling efficiency.
第二步，体外微处理器对按键指令进行解析，根据当前页面标志位和行标志位来确定指令类型，检查指令参数是否超出范围，指令包括刺激电流调节、模式选择、刺激频率调节和刺激时间设置；In the second step, the external microprocessor parses the key command, determines the command type according to the current page flag and row flag, and checks whether the command parameters are out of range. The commands include stimulation current adjustment, mode selection, stimulation frequency adjustment, and stimulation time setting;
第四步，检测蓝牙是否处于连接中，如果蓝牙未连接，则返回等待，如果检测到体外蓝牙通讯模块与体内蓝牙通讯模块建立连接，则通过蓝牙发送指令，并将参数更新并更新显示模块上的数据。The fourth step is to detect whether the Bluetooth is connected. If the Bluetooth is not connected, return to waiting. If it is detected that the external Bluetooth communication module is connected to the internal Bluetooth communication module, send instructions via Bluetooth, update the parameters and update the data on the display module.
2、体内电刺激器的软件控制方法2. Software control method of in vivo electrical stimulator
体内电刺激器的体内微处理器通过串口中断服务子程序接收来自体外控制器发送的数据。体内微处理器的接收寄存器收到一个字符的数据产生一次串口中断，将数据读取到体内微处理器中(数据包括刺激电流大小、模式、刺激频率、开启和停止输出指令)，再根据串口中断接收到的数据选择输出模式、计算输出电平的大小输出相应刺激信号，并启动负反馈调控算法对输出进行调整。The internal microprocessor of the internal electrical stimulator receives data sent from the external controller through the serial port interrupt service subroutine. When the receiving register of the internal microprocessor receives a character of data, a serial port interrupt is generated, and the data is read into the internal microprocessor (the data includes the stimulation current size, mode, stimulation frequency, start and stop output instructions), and then the output mode is selected according to the data received by the serial port interrupt, the output level is calculated, the corresponding stimulation signal is output, and the negative feedback control algorithm is started to adjust the output.
体内电刺激器的主程序控制流程图如图16所示，具体步骤如下：The main program control flow chart of the in vivo electrical stimulator is shown in FIG16 , and the specific steps are as follows:
第一步，体内微处理器上电初始化后持续检测体内蓝牙通讯模块是否处于连接状态，如果体内蓝牙通讯模块未连接，则保持等待，直到检测到体内蓝牙通讯模块已经与体外蓝牙通讯模块连接，才执行后续步骤；The first step is to continuously detect whether the in-vivo Bluetooth communication module is in a connected state after the in-vivo microprocessor is powered on and initialized. If the in-vivo Bluetooth communication module is not connected, the in-vivo Bluetooth communication module is kept waiting until it is detected that the in-vivo Bluetooth communication module has been connected to the in-vivo Bluetooth communication module before executing the subsequent steps.
第二步，判断串口通过体内蓝牙通讯模块接收到体外控制器发送的数据后对数据进行校验，检查指令格式，如果校验不通过，则抛弃当前数据，重新等待接收数据，直到有数据通过校验才执行后续步骤；The second step is to determine that the serial port receives data sent by the external controller through the internal Bluetooth communication module, and then verify the data and check the instruction format. If the verification fails, the current data is discarded and the receiving data is waited for again until the data passes the verification before executing the subsequent steps;
第三步，对传输的指令进行参数检查，判断指令的参数是否在调控范围内，如果超出调控范围则拒绝执行当前指令，重新等待新指令，如果数据通过参数检查，则向体外控制器发送确认接收指令，并执行后续步骤；The third step is to perform parameter check on the transmitted instruction to determine whether the parameters of the instruction are within the control range. If they are beyond the control range, the current instruction is rejected and a new instruction is waited for again. If the data passes the parameter check, a confirmation instruction is sent to the in vitro controller to execute the subsequent steps.
第四步，根据指令选择相应的模式，设置负反馈调节算法参数，开启电刺激输出，每隔1s，将实时检测到的电刺激输出电流发送回体外控制器，直到接收到停止指令；The fourth step is to select the corresponding mode according to the instruction, set the negative feedback adjustment algorithm parameters, start the electrical stimulation output, and send the real-time detected electrical stimulation output current back to the external controller every 1 second until a stop instruction is received;
3、负反馈调控电刺激输出强度的控制方法3. Negative feedback control method for electrical stimulation output intensity
本发明的负反馈调控方法可根据当前的刺激电流强度实时调整装置的输出强度，由负反馈调控算法实现，其软件流程图如图17所示。The negative feedback control method of the present invention can adjust the output intensity of the device in real time according to the current stimulation current intensity, which is implemented by a negative feedback control algorithm, and its software flow chart is shown in Figure 17.
该算法通过采集刺激电流信号，利用PID算法输出调整电流信号，PID算法在定时器中断服务中实现，具体步骤为：定时器中断产生后，关闭定时器，变量ADC_data中存储当前时刻采集的电刺激输出电流大小，以ADC_data作为PID算法的输入参数，计算出电流信号调整值It，调整电流It经比例换算为DAC输出电压强度。The algorithm collects the stimulation current signal and uses the PID algorithm to output the adjusted current signal. The PID algorithm is implemented in the timer interrupt service. The specific steps are: after the timer interrupt occurs, the timer is turned off, and the variable ADC_data stores the magnitude of the electrical stimulation output current collected at the current moment. ADC_data is used as the input parameter of the PID algorithm to calculate the current signal adjustment value It, and the adjusted current It is converted into the DAC output voltage intensity through proportionality.
4、模式选择软件控制方法4. Mode selection software control method
模式选择包括3种工作模式：参数设置模式、直流电刺激模式和脉冲电流电刺激模式；系统默认处于参数设置模式，当体内微处理器接收到模式选择指令后，根据相应的指令执行后续步骤，其中初始模式状态标志为cs.pwm.sw＝0，cs.dc.sw＝0，表示参数设置模式，其具体步骤包括：Mode selection includes three working modes: parameter setting mode, direct current stimulation mode and pulse current stimulation mode. The system is in parameter setting mode by default. When the microprocessor in the body receives the mode selection instruction, it executes the subsequent steps according to the corresponding instruction. The initial mode state flag is cs.pwm.sw=0, cs.dc.sw=0, indicating parameter setting mode. The specific steps include:
接收到直流电刺激模式设置指令后，模式标志位cs.dc.sw置为1，cs.pwm.sw置为0，同时对刺激参数进行设置，包括刺激电流和时间设置，同时将PID算法的目标值设置为刺激电流值，设置完成后将cs.dc.sw置为0，将直流电刺激开关状态标志dc.sw置为1，直流模式的输出方式为恒流输出设定的电刺激电流值；After receiving the DC stimulation mode setting instruction, the mode flag cs.dc.sw is set to 1, cs.pwm.sw is set to 0, and the stimulation parameters are set at the same time, including the stimulation current and time settings. At the same time, the target value of the PID algorithm is set to the stimulation current value. After the setting is completed, cs.dc.sw is set to 0, and the DC stimulation switch state flag dc.sw is set to 1. The output mode of the DC mode is the constant current output of the set electrical stimulation current value;
接收到脉冲电刺激模式设置指令后，模式标志位cs.pwm.sw置为1，cs.dc.sw置为0，同时对刺激参数进行设置，包括刺激电流、刺激频率和时间设置，同时将PID算法的目标值设置为刺激电流值，设置完成后将cs.pwm.sw置为0，将脉冲电流电刺激开关状态标志pwm.sw置为1。After receiving the pulse electric stimulation mode setting instruction, the mode flag cs.pwm.sw is set to 1, cs.dc.sw is set to 0, and the stimulation parameters are set at the same time, including the stimulation current, stimulation frequency and time settings. At the same time, the target value of the PID algorithm is set to the stimulation current value. After the setting is completed, cs.pwm.sw is set to 0, and the pulse current electric stimulation switch state flag pwm.sw is set to 1.
综上所述，本发明公开了一种无源、具有负反馈调整刺激电流功能的植入式电刺激仪器，主要是包括含有接收感应耦合输电线圈的体内电刺激器和含有发射感应耦合输电线圈的体外控制器，故本发明的植入式电刺激仪器不需要将电池植入体内，而是通过耦合输电线圈的感应耦合传输的能量进行实时供给，从而使得植入式电刺激仪器具有体积小、重量轻的特点；同时通过体外蓝牙通讯模块和体内蓝牙通讯模块实现体外控制器和体内电刺激器的通讯，通过体外控制器进行参数的设置、指令的控制、发射频率的调整以及体内刺激电流的实时显示，使用方便；另外体内微处理器利用负反馈调控算法实现刺激电信号精确输出，通过对电刺激实时电信号的采集滤波，进而调节输出强度，避免了盲目刺激，可提供准确的电刺激输出强度。In summary, the present invention discloses a passive implantable electrical stimulation instrument with a negative feedback adjustment stimulation current function, which mainly includes an in-vivo electrical stimulator containing a receiving inductively coupled power transmission coil and an in-vitro controller containing a transmitting inductively coupled power transmission coil. Therefore, the implantable electrical stimulation instrument of the present invention does not need to implant a battery into the body, but instead uses the energy transmitted by the inductive coupling of the coupled power transmission coil for real-time supply, thereby making the implantable electrical stimulation instrument small in size and light in weight. At the same time, the communication between the in-vivo controller and the in-vivo electrical stimulator is realized through the in-vivo Bluetooth communication module and the in-vivo Bluetooth communication module, and the in-vivo controller is used to set parameters, control instructions, adjust the transmission frequency, and display the in-vivo stimulation current in real time, which is convenient to use. In addition, the in-vivo microprocessor uses a negative feedback control algorithm to realize the precise output of the stimulation electrical signal, and adjusts the output intensity by collecting and filtering the real-time electrical signal of the electrical stimulation, thereby avoiding blind stimulation and providing accurate electrical stimulation output intensity.
最后说明的是，以上实施例仅用以说明本发明的技术方案而非限制，尽管参照较佳实施例对本发明进行了详细说明，本领域的普通技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本技术方案的宗旨和范围，其均应涵盖在本发明的权利要求范围当中。Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution, which should be included in the scope of the claims of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410192578.5ACN117959600A (en) | 2024-02-21 | 2024-02-21 | A passive implantable electrical stimulation device with negative feedback function to adjust stimulation current |
| Application Number | Priority Date | Filing Date | Title |
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| CN202410192578.5ACN117959600A (en) | 2024-02-21 | 2024-02-21 | A passive implantable electrical stimulation device with negative feedback function to adjust stimulation current |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202410192578.5APendingCN117959600A (en) | 2024-02-21 | 2024-02-21 | A passive implantable electrical stimulation device with negative feedback function to adjust stimulation current |
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