本文選題：人工肛門括約肌 + 肛門失禁��； 參考：《上海交通大學(xué)》2015年博士論文

【摘要】：肛門失禁(Fecal Incontinence,FI)是指肛門括約肌失去對(duì)糞便及氣體排出的控制能力,是臨床上常見(jiàn)病癥,此病癥雖不致命但卻給患者帶來(lái)生活不便和身心痛苦。現(xiàn)有的人工肛門括約肌無(wú)法感知腸道糞便量,不能自主控制排便時(shí)間,需要通過(guò)反復(fù)擠壓的方式控制假體,且手術(shù)方式復(fù)雜。隨著科技的發(fā)展和患者對(duì)生活質(zhì)量要求的不斷提高,針對(duì)越來(lái)越普遍的肛門失禁病癥,結(jié)合經(jīng)皮供能和射頻通信控制技術(shù),研究集腸道控便和便意檢測(cè)為一體的植入式智能人工括約肌系統(tǒng)已經(jīng)成為醫(yī)工研究的一個(gè)重要方向。本文以國(guó)家自然科學(xué)基金(NO.31170968)和上海交通大學(xué)醫(yī)工交叉基金資助項(xiàng)目(NO.YG2009ZD103)為依托,深入研究了基于經(jīng)皮供能的反饋式人工肛門括約肌系統(tǒng)的關(guān)鍵技術(shù),采用理論、工程和實(shí)驗(yàn)相結(jié)合的方法,完成了射頻通信控制系統(tǒng)、經(jīng)皮供能系統(tǒng)和仿生括約肌假體三大模塊的研究設(shè)計(jì)工作,并結(jié)合完整的離體和動(dòng)物實(shí)驗(yàn),驗(yàn)證了系統(tǒng)的可行性和功能,具體工作分為以下幾個(gè)方面:1.根據(jù)本文的研究目標(biāo)和技術(shù)方案,通過(guò)硬件模塊設(shè)計(jì)和軟件程序設(shè)計(jì)實(shí)現(xiàn)智能控制系統(tǒng)的基本功能。其中,硬件模塊主要涉及無(wú)線通訊控制模塊、生物反饋模塊、充電模塊和微控制器模塊;軟件程序設(shè)計(jì)包括基于射頻數(shù)據(jù)收發(fā)的雙向通訊程序的編寫(xiě),以及體內(nèi)系統(tǒng)控制軟件的低功耗設(shè)計(jì)。在此基礎(chǔ)上,對(duì)體內(nèi)系統(tǒng)進(jìn)行集成和生物相容性封裝,并測(cè)試了主要指標(biāo)。硬件模塊的設(shè)計(jì)和軟件程序的編寫(xiě),旨在模擬人體正常的神經(jīng)感知和控便排便機(jī)理,使系統(tǒng)具有完備的協(xié)同運(yùn)作和自主控制能力。2.通過(guò)對(duì)經(jīng)皮供能系統(tǒng)的電路建模分析發(fā)現(xiàn)鏈路耦合效率ηl對(duì)系統(tǒng)整體性能的提高起到至關(guān)重要的作用,而耦合線圈的性能又決定了ηl的高低。圍繞線圈結(jié)構(gòu)的參數(shù)化設(shè)計(jì),對(duì)平面螺線管磁片式litz線圈進(jìn)行電磁場(chǎng)建模,運(yùn)用自由空間微分場(chǎng)定律和邊界條件推導(dǎo)出關(guān)于線圈匝數(shù)nt、線徑Фc、外徑ro、內(nèi)徑ri、磁片厚度t和磁片相對(duì)磁導(dǎo)率μr的集總參數(shù)(l、m、rs)解析模型,從而為優(yōu)化鏈路耦合效率提供了重要理論依據(jù)�；趍atlab編程的圖形化設(shè)計(jì)方法和有限元分析,以高耦合效率為目標(biāo),對(duì)初次級(jí)線圈的nt、Фc、ro、ri、t、μr和層數(shù)nl做了參數(shù)化設(shè)計(jì)。優(yōu)化后的線圈組合在5~25mm的傳輸距離內(nèi),鏈路耦合效率84.91%~98.78%,與原有按照經(jīng)驗(yàn)設(shè)計(jì)的實(shí)心銅線線圈相比,平均效率提高36.1%。設(shè)計(jì)過(guò)程中,結(jié)合多組示例線圈,運(yùn)用fea仿真和實(shí)驗(yàn)測(cè)量結(jié)果驗(yàn)證解析模型預(yù)測(cè)參數(shù)的準(zhǔn)確性,以及ηl優(yōu)化方法的有效性。3.為了保證能量供給的穩(wěn)定性,建立了與線圈耦合系數(shù)、次級(jí)負(fù)載和工作頻率相關(guān)的經(jīng)皮供能系統(tǒng)傳輸方程,研究自適應(yīng)功率調(diào)節(jié)的方法,針對(duì)不同工況,分別設(shè)計(jì)了反饋式閉環(huán)頻控調(diào)節(jié)和閉環(huán)相控調(diào)節(jié)。頻控調(diào)節(jié)主要針對(duì)變耦合系數(shù)工況,通過(guò)對(duì)頻率控制方程的推導(dǎo),得到頻率與耦合系數(shù)變化的關(guān)系,從而通過(guò)調(diào)節(jié)發(fā)射頻率補(bǔ)償耦合系數(shù)變化對(duì)接收電壓的影響,離體實(shí)驗(yàn)證明當(dāng)耦合系數(shù)在0.1~0.42范圍內(nèi)變化時(shí),頻控系統(tǒng)的體內(nèi)接收功率可以穩(wěn)定在700mw,系統(tǒng)最大傳輸效率為67.5%。相控調(diào)節(jié)主要針對(duì)耦合系數(shù)和負(fù)載同時(shí)變化的工況,通過(guò)對(duì)相控方程的推導(dǎo),得到mosfets驅(qū)動(dòng)電壓的相位差與初級(jí)等效輸入電壓的關(guān)系,從而通過(guò)調(diào)節(jié)相位差補(bǔ)償工況變化對(duì)接收電壓的影響,離體實(shí)驗(yàn)表明當(dāng)耦合系數(shù)和負(fù)載分別在0.09~0.29和50~120Ω范圍內(nèi)變化時(shí),相控系統(tǒng)的體內(nèi)接收電壓可以穩(wěn)定在7v,傳輸功率根據(jù)負(fù)載情況在410~950mw范圍內(nèi)實(shí)現(xiàn)自適應(yīng)調(diào)節(jié),系統(tǒng)最大傳輸效率為74.2%。4.在實(shí)際應(yīng)用中,考慮到人體腹部皮下組織將暴露于能量線圈的電磁場(chǎng)中,運(yùn)用理論劑量學(xué)的方法,在maxwell有限元軟件中對(duì)耦合線圈及其移植環(huán)境進(jìn)行多層組織結(jié)構(gòu)的建模仿真,分析組織內(nèi)部電流密度和sar值的分布情況。仿真參數(shù)(模型結(jié)構(gòu)、組織電特性和發(fā)射電流)均設(shè)置為實(shí)際應(yīng)用值,仿真結(jié)果表明本文設(shè)計(jì)的經(jīng)皮供能系統(tǒng)對(duì)皮下組織的電磁輻射影響在安全范圍內(nèi)。5.設(shè)計(jì)了三款人工肛門括約肌假體(傳統(tǒng)液壓式假體、彈性伸縮式假體和仿恥骨直腸肌式假體)。其中,液壓式假體在較小注水量(9ml-10.5ml)的情況下可實(shí)現(xiàn)對(duì)腸壁作用壓的均勻分布(4.05kpa~7.16kpa),控制微泵在3.3v驅(qū)動(dòng)電壓下,最大流量為8.5ml/min,最大封閉壓可達(dá)70kpa。彈性伸縮式假體和仿恥骨直腸肌式假體均屬于機(jī)械仿生式假體,前者利用彈簧的自然伸張和可控等距收縮的特性,實(shí)現(xiàn)對(duì)腸壁的閉合和釋放;后者的設(shè)計(jì)靈感源自對(duì)恥骨直腸肌的解剖結(jié)構(gòu)及其功能的理解和抽象,模擬u形肌將肛管直腸連接部向前牽引形成直腸角,通過(guò)放松和收縮控制角度的大小,從而實(shí)現(xiàn)控便排便的功能。機(jī)械仿生式假體的工作原理符合括約肌功能要求,相比于水泵式括約肌系統(tǒng),體內(nèi)移植模塊更加精簡(jiǎn)。系統(tǒng)的離體實(shí)驗(yàn)結(jié)果表明上述三款假體均可以有效安全地抑制腸道內(nèi)容物滲漏,并驗(yàn)證了便意檢測(cè)的可行性。6.針對(duì)第一代水泵式人工肛門括約肌系統(tǒng)WP-AASSΙ,開(kāi)展了小香豬動(dòng)物實(shí)驗(yàn),首次驗(yàn)證了WP-AASSΙ控便排便的功能和便意檢測(cè)的可行性,積累了有關(guān)手術(shù)方式、移植部位、術(shù)后管理和系統(tǒng)測(cè)試等方面的經(jīng)驗(yàn),同時(shí)也發(fā)現(xiàn)了系統(tǒng)存在的不足。在此基礎(chǔ)上,針對(duì)優(yōu)化后的系統(tǒng)WP-AASSΙΙ,開(kāi)展了比格犬動(dòng)物實(shí)驗(yàn),進(jìn)一步探索了水泵式系統(tǒng)的控便效果和便意檢測(cè),并進(jìn)行了影像學(xué)分析,肛腸測(cè)壓分析,血清化學(xué)分析和組織病理學(xué)分析。兩次動(dòng)物實(shí)驗(yàn)均驗(yàn)證了系統(tǒng)的功能和應(yīng)用價(jià)值,為假體的設(shè)計(jì)和系統(tǒng)的優(yōu)化,以及進(jìn)一步臨床實(shí)驗(yàn)提供了寶貴的經(jīng)驗(yàn)和數(shù)據(jù)。本文對(duì)人工肛門括約肌系統(tǒng)的假體機(jī)構(gòu)、便意檢測(cè)、經(jīng)皮供能、通信控制和動(dòng)物實(shí)驗(yàn)進(jìn)行了深入研究,為智能型人工括約肌系統(tǒng)的設(shè)計(jì)和實(shí)用化提供了理論基礎(chǔ)和設(shè)計(jì)經(jīng)驗(yàn)。在論文最后,對(duì)本文的工作做了總結(jié),結(jié)合動(dòng)物實(shí)驗(yàn)的數(shù)據(jù)和經(jīng)驗(yàn),提出了今后的研究方向。
[Abstract]:Anal incontinence (Fecal Incontinence FI) refers to the anal sphincter lose the ability to control discharge of feces and gas, is a common clinical disease, the disease is not fatal but bring inconvenience to life and physical and mental pain to the patient. The existing artificial anal sphincter cannot sense the intestinal weight, control defecation time not, need to control prosthesis through repeated extrusion, and the operation is complex. With the development of science and technology and the quality of life of patients with increasing requirements for increasingly common anal incontinence symptoms, combined with transcutaneous energy and radio frequency communication control technology, control and research in intestinal defecation testing as one of the intelligent implantable artificial sphincter system has has become an important direction of biomedical engineering research. Based on the National Natural Science Foundation (NO.31170968) and the Shanghai Jiao Tong University biomedical engineering project (NO.YG2009ZD 103) based on the in-depth research of the key technology, transcutaneous energy feedback artificial anal sphincter system based on the theory and method of engineering and combining experiment, completed the RF communication control system, transcutaneous energy transmission and bionic sphincter prosthesis three modules of the design and research work, combined with in vitro and animal experiments, the feasibility and function of the system is verified, the specific work is divided into the following aspects: 1. according to the research objectives and technical scheme of this paper, through the realization of the basic functions of the intelligent control system hardware design and software program design. The hardware module mainly relates to the wireless communication control module, biological feedback module, charging the module and the microcontroller module; software design including the preparation of radio data transceiver based on two-way communication program, and the software control system in low power consumption based design. On the basis of in vivo, system compatibility package integration and biology, and test the key indicators. And software program of hardware module, designed to simulate the neural control of human perception and normal defecation mechanism, so the system has to work and self control ability of.2. on the circuit model of transcutaneous energy supply system analysis shows that the improved link efficiency l coupling on the performance of the whole system plays an important role in the comprehensive performance, coupling coil determines the level of ETA L. Around the parametric design of the coil structure, electromagnetic field model of planar magnetic solenoid type Litz coil, the use of free space differential law and the boundary conditions are derived about the number of turns of the coil wire diameter NT, diameter C, diameter RO, diameter RI, thickness T and magnetic disk relative permeability lumped parameter r (L, m, RS) analytical model, so as to optimize the coupling efficiency chain road Provides an important theoretical basis. Based on the analysis of the graphic design matlab programming method and finite element method, with high coupling efficiency as the goal, the primary and secondary coils NT, C, RO, RI, t, R and NL layers do parametric design. The optimized coil combination in transmission distance in 5~25mm link, the coupling efficiency of 84.91%~98.78%, and according to the original design of the solid copper wire coil experience compared to the average efficiency of 36.1%. in the design process, combined with multiple sample measuring coil, FEA simulation and experimental results verify the accuracy of prediction parameters using the analytical model, the effectiveness of the.3. and l optimization methods in order to ensure the stability of energy supply, establish the coil and the coupling coefficient, secondary load and working frequency related to the transcutaneous energy transmission equation, method of adaptive power adjustment research, according to different working conditions were designed for closed loop feedback control loop and frequency adjustment Phase control. Frequency control regulation for variable coupling coefficient conditions, through the derivation of frequency control equations of the relationship between changes of frequency and coupling coefficient, thereby regulating the variation of transmission frequency compensation of coupling coefficient on the effect of receiving voltage, in vitro experiments show that when the coupling coefficient changes in the range of 0.1~0.42, frequency control system in the received power can be stabilized in 700MW system, the maximum transmission efficiency is 67.5%. phase control mainly for coupling coefficient and load change condition, through the derivation of the phase control equation of the relationship between phase difference and driving voltage of MOSFETs primary equivalent input voltage, thereby regulating the phase difference compensation condition change effect on the receiving voltage. In vitro experiments showed that, when the coupling coefficient and load respectively in 0.09~0.29 and 50~120 range, the body receives the voltage can be stabilized in the 7 phase control system V, the transmission power according to the load in the range of 410~950mw to realize the adaptive regulation system, maximum transmission efficiency of 74.2%.4. in the practical application, taking into account the subcutaneous tissue of the abdomen of the human body electromagnetic coil will be exposed to energy, using the method of theoretical dosimetry, modeling and Simulation of multi organizational structure for coupling coil and its transplant environment in Maxwell finite element in the software, analyze the distribution of internal current density and SAR value. The simulation parameters (model structure, electrical properties and emission current organization are set) for actual application value, the simulation results show that the transcutaneous energy impact of electromagnetic radiation on the subcutaneous tissue of the system in a safe range of.5. designed three kinds of artificial anus sphincter prosthesis (traditional hydraulic prosthesis, elastic telescopic prosthesis and imitation puborectal muscle implants). The hydraulic components in small water injection (9ml-10.5 Ml) of intestinal wall pressure distribution can be the case (4.05kpa~7.16kpa), control of micro pump in 3.3V driving voltage, the maximum flow rate is 8.5ml/min, the maximum sealing pressure can reach 70kpa. elastic telescopic prosthesis and imitation puborectal muscle type prosthesis are belongs to the mechanical characteristics of the former using bionic prosthesis, natural stretch and spring controlled isometric contraction, the intestinal wall closure and release; the latter design inspiration from the anatomy structure of the puborectalis muscle and its function of understanding and abstract, simulation U shaped muscle will anorectal junction formed by rectum forward traction angle, relaxation and contraction of control angle, so as to realize the function of defecation control. The working principle of the mechanical bionic prosthesis with sphincter function, compared to the pump type sphincter system, in vivo module system more streamlined. In vitro experiment results show that the above three models The prosthesis was effective and safe to inhibit intestinal leakage of content, and verifies the feasibility of detecting.6. meaning for the first generation of pump type artificial anal sphincter system WP-AASS 1, launched a small pig animal experiment, for the first time to verify the feasibility of WP-AASS 1 control function and meaning of the detection of stool, accumulated about surgery, transplantation on site, postoperative management and system test experience, also found that the shortcomings of the system. On this basis, according to the optimized system of WP-AASS mode II, the canine animal experiment, to further explore the pump system control effect and meaning detection, and the imaging analysis. Anorectal manometry analysis, analysis of serum chemical analysis and pathology. Two animal experiments have proved the system's function and application value for the optimization design and the system of the prosthesis, and further clinical practice Experience has provided valuable experience and data. The mechanism of prosthesis of artificial anal sphincter system, meaning detection, transcutaneous energy, communication control and animal experiments conducted in-depth research, provide a theoretical basis and experience for the design of intelligent artificial sphincter system design and practical. At the end of this paper, the work is summarized, combined with the animal experiment data and experience, put forward the research direction in the future.

【學(xué)位授予單位】：上海交通大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2015
【分類號(hào)】：TH789;R318.1
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本文編號(hào)：1758073