【摘要】：胃食管反流病(Gastroesophageal Reflux Disease,GERD)是指胃內(nèi)容物反流入食管,引起不適癥狀和(或)并發(fā)癥的一種疾病。全世界范圍內(nèi),大約有2.5億個GERD患者。隨著GERD的發(fā)病率逐年上升,社會醫(yī)療負擔(dān)越來越重,GERD的合理診治已成為全世界關(guān)注和研究的熱點。而傳統(tǒng)的藥物治療存在治標(biāo)不治本的問題,停藥后癥狀復(fù)發(fā),患者不得不長期使用藥物。手術(shù)治療則創(chuàng)傷大,術(shù)后會有吞咽困難、腹脹和腹瀉等并發(fā)癥。食管下括約肌(Lower esophageal sphincter,LES)電刺激治療方法為難治性GERD的治療提供了一種新方法。國外基于LES電刺激治療方法推出了 EndoStim植入式LES電刺激系統(tǒng),并進行了大量的臨床實驗研究。而國內(nèi)相關(guān)研究較少,目前尚無可應(yīng)用于臨床的植入式LES電刺激系統(tǒng)。為了打破國外產(chǎn)品的壟斷,填補國內(nèi)該技術(shù)領(lǐng)域的空白,本文研究設(shè)計了一種無線供能的LES電刺激系統(tǒng)。該系統(tǒng)由體外無線控制器、無線能量傳輸模塊和植入式LES電刺激器組成。系統(tǒng)在實現(xiàn)植入式LES電刺激功能的基礎(chǔ)上,實現(xiàn)了無線能量傳輸功能,解決了 EndoStim系統(tǒng)無法外部供能的問題。本論文的研究內(nèi)容主要包括:1)無線供能的LES電刺激系統(tǒng)方案設(shè)計:在分析討論用于治療GERD的LES電刺激系統(tǒng)的功能需求與設(shè)計目標(biāo)基礎(chǔ)上,確定了無線供能的LES電刺激系統(tǒng)的設(shè)計方案。根據(jù)電磁波穿透深度和電磁輻射對人體的影響,選用4MHz作為無線能量傳輸?shù)墓ぷ黝l率。還討論了系統(tǒng)集成與封裝方案,為系統(tǒng)的模塊化設(shè)計和生物相容性封裝打下了基礎(chǔ)。2)體外無線控制器設(shè)計:分析討論了基于低功耗藍牙技術(shù)(Bluetooth Low Energy,BLE)的體外無線控制器的設(shè)計方案與工作原理。該控制器主要包括CC2541模塊、USB轉(zhuǎn)串口電路、鋰電池充電電路和電源管理電路。其中,CC2541模塊采用了與植入式LES電刺激器相同的定制電路模塊進行設(shè)計,USB轉(zhuǎn)串口電路采用CH340G芯片實現(xiàn)與上位機的串口通信。鋰電池充電電路則采用LTC4054-4.2芯片,充電電流設(shè)置為500mA。電源管理電路采用了 RT9013-33GB線性穩(wěn)壓電路。在完成了體外控制器硬件設(shè)計的基礎(chǔ)上,從CC2541開發(fā)、上位機程序開發(fā)和手機藍牙控制植入式LES電刺激器三方面進行了系統(tǒng)的軟件設(shè)計。CC2541開發(fā)過程中所采用的協(xié)議棧版本為TI的BLE-CC254x-1.3.2,開發(fā)環(huán)境為IAR 8051。上位機程序開發(fā)采用C#語言進行編程,所使用的開發(fā)環(huán)境為Visual Studio 2012。此外,使用LightBlue手機藍牙APP實現(xiàn)了對植入式LES電刺激器的控制。3)無線能量傳輸模塊設(shè)計:在分析討論了無線能量傳輸?shù)睦碚摶A(chǔ)和線圈設(shè)計方案后,確定了無線能量傳輸模塊的設(shè)計方案。該模塊包括體外能量發(fā)射電路和體內(nèi)能量接收電路。其中,體外能量發(fā)射電路由線性穩(wěn)壓器、有源晶振電路和E類功率放大器組成。其功能是將體外電源的直流電壓變換為交流電壓,并加載到發(fā)射線圈上向體內(nèi)傳輸能量。體內(nèi)能量接收電路則采用橋式整流、電容濾波和降壓-升壓型電荷泵穩(wěn)壓器LTC3245,將接收線圈上耦合得到的交流電壓變換為直流電壓。4)植入式LES電刺激器設(shè)計:分析討論了植入式LES電刺激器的設(shè)計方案與工作原理。設(shè)計了包含能量接收電路、電源管理電路、CC2541模塊、DAC電路和壓控恒流刺激電路的植入式LES電刺激器。電源管理電路分別采用RT9013-33GB、MAX1595EUA50+和MAX865EUA芯片將3.7～5V的輸入電壓轉(zhuǎn)換為CC2541模塊、DAC電路和壓控恒流刺激電路的供電電壓。DAC電路采用MAX5705芯片輸出可控電壓,控制壓控恒流刺激電路產(chǎn)生相應(yīng)大小的電流刺激脈沖。壓控恒流刺激電路采用OPA4192芯片產(chǎn)生0～8mA的電流刺激脈沖。5)植入式LES電刺激系統(tǒng)測試與實驗研究:使用美國道康寧公司的Sylgard 184型聚二甲基硅氧烷對電極導(dǎo)線和植入式LES電刺激器進行了封裝,并使用ABS塑料殼體封裝了體外控制器。完成植入式LES電刺激系統(tǒng)的封裝后,對系統(tǒng)的無線能量傳輸功能進行了測試,并給出了空氣、0.9%鹽水和豬皮3種介質(zhì)條件下系統(tǒng)正常工作的位置失配容限指標(biāo)。在此基礎(chǔ)上,以家兔為實驗對象開展了 GERD造模實驗、水灌注式食管測壓實驗和LES電刺激實驗。實驗結(jié)果表明:本文研究設(shè)計的植入式LES電刺激系統(tǒng)可以增強(恢復(fù))造模后實驗動物的LES壓力,對于治療GERD具有可行性。
[Abstract]:Gastroesophageal reflux disease (GERD) is a disease of the stomach contents to flow into the esophagus, causing discomfort and/ or complications. There are about 250 million GERD patients worldwide. As the incidence of GERD is increasing year by year, the burden of social medical care is getting more and more, and the rational diagnosis and treatment of GERD has become the focus of attention and research worldwide. and the traditional medicine treatment has the problems of no treatment and treatment, and the symptoms of the drug withdrawal after the drug withdrawal are recurrent, and the patient has to use the medicine for a long time. The surgical treatment is large, and there are complications such as dysphagia, abdominal distention, and diarrhea after operation. The electrical stimulation of the lower esophageal sphincter (LES) provides a new method for the treatment of refractory GERD. The EndoStim implantable LES electrical stimulation system was introduced based on LES electrical stimulation therapy in foreign countries, and a large number of clinical trials were conducted. At present, there are no implantable LES electrical stimulation systems that can be applied to clinical practice. In order to break the monopoly of foreign products and to fill the gap in the domestic technology field, a wireless power-powered LES electric stimulation system is designed. The system consists of an in-vitro wireless controller, a wireless energy transmission module and an implantable LES electric stimulator. The system realizes the function of wireless energy transmission on the basis of realizing the function of the electric stimulation of the implanted LES, and solves the problem that the EndoStim system cannot be externally supplied. The research contents of this paper mainly include: 1) the scheme design of LES electric stimulation system for wireless power supply: based on the analysis and discussion on the function requirement and design goal of LES electric stimulation system for treating GERD, the design scheme of LES electric stimulation system for wireless power supply is determined. according to the penetration depth of the electromagnetic wave and the influence of the electromagnetic radiation on the human body, 4MHz is selected as the operating frequency of the wireless energy transmission. This paper also discusses the system integration and packaging scheme, and lays a foundation for the modular design and the biocompatibility package of the system. 2) In-vitro wireless controller design: the design and working principle of the in-vitro wireless controller based on Bluetooth Low Energy (BLE) are analyzed and discussed. The controller mainly comprises a CC2541 module, a USB rotating serial port circuit, a lithium battery charging circuit and a power supply management circuit. The CC2541 module is designed with the same custom circuit module as the implantable LES electrical stimulator. The serial port of the USB-to-serial port adopts the CH340G chip to realize the serial communication with the upper computer. The lithium battery charging circuit adopts the LTC4054-4.2 chip, and the charging current is set to 500mA. The power management circuit adopts the RT9013-33GB linear voltage stabilizing circuit. On the basis of completing the hardware design of the in-vitro controller, the software design of the system is carried out from the development of CC2541, the development of the host computer and the Bluetooth control of the mobile phone. The protocol stack used in the development of the CC2541 is the BLE-CC254x-1. 3.2 of TI, and the development environment is IAR 8051. The host computer program is programmed with C # language, and the development environment used is Visual Studio 2012. In addition, the control of the implantable LES electric stimulator is realized by using the LightBlue mobile phone Bluetooth APP. 3) Design of the wireless energy transmission module: After the theoretical basis and the coil design scheme of the wireless energy transmission are analyzed, the design scheme of the wireless energy transmission module is determined. The module includes an in vitro energy emitting circuit and an in-vivo energy receiving circuit. wherein the in-vitro energy transmitting circuit consists of a linear regulator, an active crystal oscillator circuit and an E-class power amplifier. The function of the invention is to convert the direct current voltage of the in-vitro power supply into an alternating current voltage and to load the external power source into the transmission coil to transmit energy to the body. the in-vivo energy receiving circuit adopts a bridge type rectification, a capacitor filtering and a step-down-boost type charge pump voltage regulator LTC3245 to convert the alternating current voltage coupled on the receiving coil into a direct current voltage. The design and working principle of the implantable LES electric stimulator are discussed. An implantable LES electrical stimulator is designed that includes an energy receiving circuit, a power management circuit, a CC2541 module, a DAC circuit, and a voltage-controlled constant current stimulation circuit. The power management circuit adopts the RT9013-33GB, the MAX1595EUA50 + and the MAX865EUA chip to convert the input voltage of 3.7 to 5V to the power supply voltage of the CC2541 module, the DAC circuit and the voltage-controlled constant current stimulation circuit. The DAC circuit adopts the MAX5705 chip to output the controllable voltage, and controls the voltage-controlled constant current stimulation circuit to generate the current stimulation pulse of the corresponding size. The voltage-controlled constant current stimulation circuit uses the OPA4192 chip to generate a current-stimulating pulse of 0-8mA. and an in vitro controller is packaged using an abs plastic housing. After the encapsulation of the implantable LES electrical stimulation system, the wireless energy transmission function of the system was tested, and the position-mismatch tolerance index of the system's normal operation under the condition of air, 0.9% saline and 3 medium conditions of the pigskin was also given. On the basis of this, the experiment of GERD model, the experiment of water-filled esophagus and the electric stimulation of LES were carried out in rabbits. The experimental results show that the LES pressure of the experimental animal can be enhanced (recovered) by the implanted LES electrical stimulation system designed in this paper, and it is feasible to treat GERD.
【學(xué)位授予單位】：東南大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R571

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