【作者】 郭雄波；

【导师】 黄宗海；

【作者基本信息】 南方医科大学 ， 普通外科学， 2013， 博士

【摘要】 研究背景全球结直肠疾病的发病率不断上升,施行结肠造口术是许多结直肠疾病患者无奈的选择。近年来结肠造口患者逐渐增加,根据中国造口学会估计,中国每年新增永久性肠造口患者者约10万人,共有肠造口者约100万人,且仍有有增加趋势。结肠造口手术给患者生理、心理和经济等带来沉重负担。造口患者肛门括约功能和感知功能基本缺失,存在严重的大便失禁(fecal incontinence, FI)。为恢复正常的肛门功能,有效的控制失禁,长期以来各国学者作了许多探索,如肌肉的强化治疗、生物反馈训练、神经电刺激等,可惜效果均不太理想。在造口的处理方面,传统的方法是使用造口袋收集排泄物。造口袋有效的解决排泄物的管理难题,但佩戴造口袋给患者的生活造成极大影响,患者容易对生活失去信心,长期使用会增加皮肤感染和造口坏死等症的发生率。1986年丹麦学者Burcharth等人设计的一次性造口栓由膨胀材料制成,应用在腹壁的永久性结肠造口,该肛门栓置入造口后吸水膨胀进而封堵造口,是结肠造口处理的一次巨大进步,但该类产品为一次性用品,患者经济负担重,且存在一定并发症。人工肛门封堵器的应用使控制造口的完全性大便失禁成为可能,一定程度解决患者无法自主控制大便的痛苦。临床使用的各种造口护理产品多存在护理不方便、容易脱落、易泄漏、不能感知肠内容物和不具备调节的功能等缺点。因此,研制能判断肠内容物不同性质的智能型人工肛门封堵感知系统,能提高造口患者的生活质量,具有重要的临床意义。超声波(ultrasound, US)本质上是一种弹性介质中的机械振荡,包括纵向振荡(纵波)和横波振荡(横波)两种形式,其中纵波具有较好的实际应用价值。纵波的特点是具有束射特性、能定向传播、方向性强、能量远大于相同振幅的一般声波、并具有很强的穿透力。不同物质对超声波有各自对应的声阻抗特性,反映该物质传播超声的特性,声阻抗特性越高越有利超声波的传播,通常固体的声阻抗最高、液体其次、气体最低。肠道内容物的典型状态包括气体状态、固体状态和液体状态,当超声经过不同状态的肠道内容物时会发生相应的衰减,传感器接收到不同强度的超声信号后把声波能量转换成相应的电压信号。利用超声探测技术和微系统技术模拟感知神经感受肠内容物的功能,相信在不久的将来该技术可作为智能型人工肛门封堵器的感知系统应用于临床。目的研制智能型人工肛门封堵器的模拟感知神经系统,包括设计智能型排便感知系统的原理图、电路设计、硬件调试、软件编程、样机制作；人为模拟家兔肠内容物不同状态的模型制备；验证制作的模拟感知系统在动物模型上的效果,为智能型人工肛门封堵器的最终应用提供支持。方法一、反射型超声传感器探测系统的的制备1、通过对TCT40-18FS-1.2B探测仪改装,采用SendK型5V直流变压器作为系统电源,DT9205型数字万用表显示电压数值,超声发射频率与超声波探头频率都为2MHz,两级放大电路的放大倍数依次为48与35。超声信号发射电路是整个装置最初始工作信号的产生部位,驱动超声波发射器,发射用于探测超声波。2、测量过程由电源提供能量,经超声发射电路激发后由探头发射超声波,集成的一体化探头捕获通过不同浸入状态的反射信号,经放大电路的放大作用,信号传到单片微型计算机,单片机处理后将电压信号传送到液晶显示屏上。为了更好的显示电压结果,将数字万用表的负极和正极分别与超声放大电路末端的引出线与接地线相接,把数字万用表量程的旋钮指向2V位置,读取数字万用表的电压读数。3、超声传感器在每一份生理盐水里的状态包括三种：A、超声探头置于空气中不与生理盐水接触,所测数据纳入未浸入组；B、把超声探头慢慢向下牵引使超声探头平面半径的一半浸入生理盐水中,再次读取数字万用表数值,所测的数据纳入半浸入组；C、继续牵引超声探头直至其完全浸入水中,读取数据纳入全浸入组,每个系列测量动作重复五次,记录其平均值。4、用重复测量方差分析观察三种状态电压值是否有显著性差异。二、反射型超声传感器对肠内容物不同状态的信号提取1、超声传感器的放大电路后接入一阶滤波电路、二阶滤波电路和整流电路,其中,整流电路可把超声信号从交流信号转换为直流信号,各级滤波电路用于滤去输出电压的纹波,以减小脉动直流电压的交流成分,只保留直流成分,降低了输出电压的纹波系数,使波形平滑,便于读数。2、手术操作经家兔耳缘静脉缓慢注入20%的氨基甲酸乙酯(urethane乌拉坦),5ml/kg,约5分钟后观察麻醉成功,将家兔固定于操作台,按照常规消毒、铺巾,取腹正中线为手术切口,逐层进腹,充分暴露肠管。以结肠远端距离肛门大约20cm处为起点,向结肠近端游离肠管,长度约10cm左右,将游离的肠管末端作横向切开,肠管备用。3、肠管内容物的不同状态模型准备空虚状态：把游离肠管内的原有肠内容物逐一排出,并于断端置入反射型超声传感器的超声探头,夹闭断端；气体状态：10ml注射器连接三通管,三通管另一端连接头皮针管,头皮针针头剪除,将管子置入游离肠管,向肠腔内注入10ml空气；固体状态：将肠内注射的气体排空,由结肠近端逐渐向远端挤压,使大便颗粒抵达超声探头处；流体状态：向结肠近端挤压粪便颗粒使肠管稍微松弛,向肠管内注入生理盐水5m1,并使两者得到充分混匀呈流动状态。4、电压测量将反射型超声传感器调试完毕,接通电源,测量不同状态下的电压值,每种状态下随机测量5次,经由集成电路的显示,在液晶显示屏上表现为不同的电压数值。为了便于观察,将数字万用表的正负极分别和整流电路的引出线与接地线相连,读取万用表的数值,取平均值。5、用重复测量方差方法观察肠管内容物四种不同状态电压值是否有显著性差异。三、智能型人工肛门封堵器模拟感知神经的制作与使用1、采用C++型计算机语言进行软件编程,使用ICC7.0软件开发工具,软件语言对肠管内气体状态、固体状态、流体状态和空虚状态四种阈值做定义如下：#define V GASEOUS ((295×400+500)/1000)#define V SOLID ((455×400+500)/1000)#define V LIQUID ((598×400+500)/1000)2、报警系统的设置单片机的输入电压、蜂鸣器及震动子和LED灯变化与肠管内容物的不同状态的关系：当U≤295mV时,绿灯亮,蜂鸣器发出单音节“嘀”音,震动子处于工作状态,提示肠管内容物为气体状态；当295mV<U≤455mV,蓝灯亮,蜂鸣器发出双音节“嘀嘀”音,震动子处于工作状态,提示肠管内容物为固体状态；当455mV<U≤598mV时,红灯亮,蜂鸣器发出“紧急”声音,震动子处于工作状态,提示肠管内容物为流体状态；U>598mV时,白灯亮,蜂鸣器和震动子处于静止状体,提示肠管处于空虚状态。3、手术操作经家兔耳缘静脉缓慢注入20%的氨基甲酸乙酯(urethane乌拉坦),5ml/kg,约5分钟后观察麻醉成功,将家兔固定于操作台,按照常规消毒、铺巾,取腹正中线为手术切口,逐层进腹,充分暴露肠管。以结肠远端距离肛门大约20cm处为起点,向结肠近端游离肠管,长度约10cm左右,将游离的肠管末端作横向切开,肠管备用。4、肠管内容物的不同状态准备空虚状态：把游离肠管内的原有肠内容物逐一排出,并于断端置入超声探头,夹闭断端；气体状态：10ml注射器连接三通管,三通管另一端连接头皮针管,头皮针针头剪除,将管子置入游离肠管,向肠腔内注入10ml空气；固体状态：将肠内注射的气体排空,由结肠近端逐渐向远端挤压,使大便颗粒抵达超声探头处；流体状态：向结肠近端挤压粪便颗粒使肠管稍微松弛,向肠管内注入生理盐水5m1,并使两者得到充分混匀呈流动状态。5、模拟感知实验及报警将反射型超声传感器调试完毕,接通电源,超声探头置入肠管断端,每种状态下随机测量5处肠管,观察LED灯的亮灯情况和蜂鸣器报警情况,4种状态共计400个数据纳入结果分析。数据结果仅作统计学描述。结果一、反射型超声传感器探测系统的的制备超声传感器能捕获到超声波信号,集成的一体化探头、发射电路及接收电路、换能器及放大电路可以达到一定的工作程度,且传感器各零配件组装完整,单片机的嵌入程序运行正常,各硬件之间兼容性良好。未浸入组(343.850±2.110mV)<半浸入组(637.600±8.009mV)<全浸入组(943.350±3.856mV),三种不同浸入状态的电压信号之间的差异有统计学意义(F=71675.880,P=0.000,<0.05),三种不同浸入状态电压信号的数值之间的多重比较差异也有统计学意义,未浸入组、半浸入组和全浸入组之间两两比较均P=0.000,<0.05。信号电压值在空气中(9mV)和水中(16mV)的波动范围较小,在临界面的半浸入状态波动较大(39mV)。二、反射型超声传感器对肠内容物不同状态的信号提取气体状态电压信号(257.120±7.534mV)<固体状态电压信号(398.120±21.819mV)<流体状态电压信号(507.240±14.357mV)<空虚状态的电压信号(658.560±11.407mV)。各种状态之间电压信号的比较有显著性差异(P=0.000,<0.05)。四种电压信号之间存在着“空白区域”：气体状态的电压信号最大值和固体电压信号的最小值差距为40mV,固体电压信号的上限与流体的电压信号最小值差距为30mV,流体电压信号的最大值和空虚状态的电压信号最小值差距为76mV。三、智能型人工肛门封堵器模拟感知神经的制作与使用LED灯和蜂鸣器及震动子均运行良好,起到较好的反馈作用。肠管处空虚状态时判断正确99次,误判1次,误判为气体状态；对气体状态的正确判断100次,错误0次；对固体状态正确判断为95次,错误5次,其中3次误判为气体状态,2次误判为流体状态；对流体状态的正确判断为98次,错误判断2次,均误判为气体状态。结论肛门失禁是多种原因所致的肛门自制紊乱,以人工肛门造口最常见,该病治疗的难点在于功能重建,本文总结了人工肛门封堵器的研究现状,设计制作了能感知肠内容物不同状态的智能型感知系统。我们制作的反射型超声传感器能捕获超声信号,整合的超声发射电路与接收电路、波换能器、滤波电路、放大电路能够进行一定程度的工作。首先能将肠内容物不同状态的信息转换为相应的电压信号,为进一步在动物实验上获取不同状态的肠内容物信号奠定基础；其次反射超声传感器能够分辨不同状态的肠内容物,为智能型肠内容物的感知神经研究提供理论支持；模拟感知系统能通过多种途径有效的反馈肠内容物的有无和肠内容物的不同状态,一定程度解决了结肠造口等多种疾患缺乏感知肠内容物并区分肠内容物能力的不足。利用超声波探测不同状态的肠内容物是一种可行的方法,可望应用于临床。创新之处1、利用超声探测技术制作“智能型肠内容物不同状态的感知系统”,该反射型超声传感器能有效判断肠管内容物的有无。2、该“智能型肠内容物感知神经”能分辨不同状态的肠内容物并将信息反馈,为智能型人工肛门封堵器的进一步研制提供有力支持。更多还原

【Abstract】 Background:The morbidity of colorectal disease is increasing nowadays. Many patients who have colorectal disease have to undergo a colostomy. Patients with colorectal fistula are rising year by year. It is said that100thousand perpetual colostomy patients are increasing every year and the total number is1million now. Colostomy is a heavy burden to the patients, includes physiology psychology and economy. Patients with stoma have severe fecal incontinence, they loss the function of continence and apperception. Scholar from all over the world have used some process to recover the function of anus, for example, intensive therapy of pelvic floor muscle, biofeedback training and electric stimulation of nerve. But the effect is not well enough.The orthodox method to care of stoma was ostomy bag. It could get rid of the diachorema but had badly influence to the patient. It also had the complication of skin infection and stoma necrosis. Burcharth used a stoma plug to control faeces in1986. The plug was made of dilatation material. It could expand when it was wet and control faeces. Though the plug had certain effect, it was disposable and had some complication. The use of artificial anus occluder was a new way to get rid of stoma. But all the nursing productions have the following insufficient, not convenient nursing, easily leakage, easy to fall off and can’t autonomic regulation. So, to make an intellectual artificial anus occluder is clinical valuable.Ultrasound is a mechanical vibration in elastic medium. In includes length wise vibration and transversal vibration. Between them length wise vibration is widely used. It has the character of beam characteristics, direction propagation, strong direction, strong penetrability and its energy is stronger than the other sonic wave of the same amplitude. Various media have corresponding acoustic impedance. The higher the acoustic impedance characteristics, the better ultrasound spread. Usually, the solid has the highest acoustic impedance, followed by liquid and gas. The typical example of intestinal intent includes gas state, solid state and liquid state. The ultrasonic signal corresponding attenuation when it transmission in different intestinal content. The sensor translates ultrasonic signal into electrical signal.Simulation of sensory nerve could cognitive intestinal content by the help of ultrasonic detection and micro system and may play an important role in the near future.Objective:The object is to develop an intelligence sensory perceptual system of artificial anal occluder. The system consists of basic circuit, circuit design, software programming, hardware debug and specimen fabrication. Simulates various intestinal contents of rabbits and authenticate its effect.Methods:1. The preparation of reflection ultrasonic detecting system.Sendk type5V DC power, DT9205digital multimeter and modified reflection-type ultrasonic signal detection system were used. The system was modified of TCT40-18FS-1.2B detector. The emission frequency was2MHz and the amplifier magnification of reception circuit was48and35, respectively.The radiating circuit emits ultrasonic by the emitter and the reception circuit receives the signal. The ultrasonic signal translates into electrician signal by the help of amplifier circuit and filter circuit. The voltage value displays on the digital multimeter.There are three capture state of the water. First, the probe stays in air. Second, the probe is partial immersion. Third, the probe is totally immersion. Every state has20voltage values and SPSS is used to statistics. Repeated ANOVA is used to test whether there is significant difference. A value of P<0.05was considered statistically significant.2The abstraction of different intestinal contents by ultrasonic sensoryTwenty New Zealand white rabbits of either sex, weight (2.5±0.2) kg, provided by the Laboratory Animal Center of Southern Medical University, in the general level of the Southern Medical University Laboratory Animal Center of feeding. All surgical procedures on rabbits were carried out under sterile conditions. Anesthesia was induced and maintained with urethane (5ml/kg body weight). The rabbits were fixed in the console after successfully anesthesia. Abdominal midline incision was carried out and bowel was exposed. About10cm distal colon was dissociated20cm from the anus. Then a transverse incision was made at the end of the dissociation bowel.Following are the preparation of the intestinal contents of different state. The vacuity state, the granular stool was removed from the bowel and the ultrasonic probe was placed in and fixed. Gaseous state, air of10ml was injected into the intestinal lumen with a syringe. Solid state, air in the intestinal lumen was pulled out and granular stool from the proximal colon was push to the probe. Liquid state, saline of5ml was injected to the intestinal lumen and mixed up with the granular stool. Each state was measured randomly for five times and the observed effects were recorded accurately.The simulated sensory nerve was used to detect the voltage value of various sate. Every state has100voltage values and SPSS is used to statistics. Repeated ANOVA is used to test whether there is significant difference. A value of P<0.05was considered statistically significant.3. The preparation and use of intelligence artificial sensory system of anus occluderPreviously study had found that there were significant difference among the voltage signals and three nonoverlapping regions were existed among the four conditions. As a result, the definition of the four conditions was made through the ICC7.0program as followed,#define V GASEOUS ((295*400+500)/1000)#define V SOLID ((455*400+500)/1000)#define V LIQUID ((598*400+500)/1000)U<295mV, gaseous state, the green light shone and the alarm device vibrated, the buzzer sounded monosyllabic "beep" at the same time.295mV<U≤455mV, solid state, the blue light shone and the alarm device vibrated. Meanwhile the buzzer sounded two-syllable "beep".455mV<U≤598mV, liquid state, red light shone and the alarm device vibrated while the buzzer sounded "the urgent" when there was liquid in the bowel. U>598mV, vacuity state, the indicator light (white light) shone while the alarm device and the buzzer were in a quiescent state. The probe could receive the ultrasonic signal and translate into electric signal through microcont roller unit. Then electric signal was translated into analog signal by the help of C++language and the LED light could shine corresponding color, the alarm device could respond as well. Experimental animal, surgical procure and preparation of intestinal content were the same as above. The ultrasonic sensor was used to detect the signal of the intestinal contents,100times for each state. And the SSN could feedback according to different conditions. A "correct" was recorded if the SSN made a right judgment. Otherwise was an "error" and the detail information would be recorded as well. Totally there were400numerous collected and under statistics.Results:1. The preparation of reflection ultrasonic detecting system.The ultrasonic detecting system could capture the ultrasonic signal and translated into electrical signal. The air state (343.850±2.110mV) had the lowest voltage value and the partial immersion (637.600±8.009mV) was higher while the totally immersion (943.350±3.856mV) was the highest. There was significal difference among the three state (F=71675.880, P=0.000,<0.05). The air state (9mV) had the lowest fluctuation and the totally immersion (16mV)was higher while the partial immersion (39mV) was the highest.2The abstraction of different intestinal contents by ultrasonic sensoryThere was a significant difference among the voltage signals of the4conditions (P=0.000). Multiple comparisons showed that significant differences existed in each pair of the4conditions (P=0.000). Three signal blank regions existed in the4conditions. The gas condition (257.120±7.534mV) had the lowest voltage value and the solid condition (398.120±21.819mV) was higher. The voltage value of liquid condition (507.240±14.357mV) was still higher than solid condition while the vacuity condition (658.560±11.407mV) had the highest. There was40mV between the max of gas condition and the min of solid condition while there was30 mV between the max of solid condition and min liquid condition. The voltage value between the max of liquid condition and the min of vacuity condition was76mV.3. The preparation and use of intelligence artificial sensory system of anus occluderThe simulated sensory nerve worked well. There were99times correct and1time error in the vacuity state while there were98times correct and1time error in the liquid state. There were95times correct and5times error in solid state and no error in gas state.Conclusions:Anal incontience is restraint confused for some factor. Treatment difficulties is reconstruction. The article summerizes the research staus of artificial anal occluder and makes a reflection ultrasonic sensor which can sensory different state of intestinal content. The circuit of the sensor is made of emission circuit, reception circuit, filter circuit and amplifier circuit. It can capture ultrasonic signal and translate into electrical, distinguish various contents inside intestinal lumen and makes three forms intellect feedback. The reflection ultrasonic sensor may use inintellect artificial anal occluder in the near future.更多还原