原位植入式智能人工肛门括约肌系统的研制
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摘要
研究背景
大便失禁(fecal incontinence, FI)是指由各种原因所致的不能自主控制液体或固体大便排出,并持续一个月以上。临床上主要表现为排便不能控制,是肛肠外科常见的疾病之一。研究表明成年人大便失禁的发生率从5%-10%不等,其中1%-2%的患者的工作和生活受到了重大影响。大便失禁是一个卫生学和社会学问题,给患者的身心造成了极大的痛苦。由于大便失禁的特殊性,相当一部分患者因感到难以启齿和不被社会接受而选择放弃寻求专业治疗。引起大便失禁的原因很多,包括解剖结构、生理状态或精神社会因素等的异常,如括约肌和／或盆底肌先天性畸形、神经系统疾病、直肠低位肿瘤、外伤和产伤等。可以预见,随着直肠低位肿瘤发病率的升高、寿命的延长以及精神心理状态的下降,大便失禁的发生率也将随之升高。
随着的大便失禁发病率的升高,使其受到越来越多的重视,对大便失禁的研究也逐渐增多,越来越多的治疗方法应用于临床,比如生物反馈治疗、直肠敏感性训练、骶神经电刺激以及自体组织重建肛门,虽然现有的这些内、外科治疗对轻度不完全性的大便失禁有着一定的疗效,但是对于某些原因(如直肠低位肿瘤)所致的肛门括约肌及其周围神经完全性损毁造成的完全性大便失禁的治疗却并不理想。人工尿道括约肌在治疗尿失禁中的成功应用,为人工肛门括约肌治疗大便失禁提供了一条崭新的策略。人工肛门括约肌的研究和应用使部分病人重新获得了控制排便的能力。然而,现有的人工肛门括约肌却存在诸如缺乏感知和反馈,压迫肠管导致缺血缺氧性并发症,植入手术复杂,操作不便等诸多缺陷,以至于限制了人工肛门括约肌的推广和应用。
研究目的
基于上述原因,本研究拟针对现有人工肛门存在的缺陷,根据人体解剖学和排便控制原理,运用生物医学工程学技术,研制一种具有感知和反馈功能的,符合人体解剖学原理的,能有效控制大便流出的,高度集成使用方便的原位植入式智能人工肛门系统,为人工肛门的研究和应用奠定基础。
方法
一、生物反馈式人工肛门感知系统的研制
1、人工肛门压力检测套囊的制作：人工肛门压力检测套囊为一独立的套囊,将柔软的硅胶薄膜管放入刚性的聚乙烯管中,再将硅胶薄膜管两端反折套在聚乙烯管两端并密封形成封闭的套囊,经套囊外壁引出一条与囊腔相通的导水管。
2、肠腔内压与压力检测套囊压力关系测定：用三通管将压力传感器、压力检测套囊和注射器连通,压力传感器接入PCLAB-UE生物医学信号采集处理系统。将实验肠管穿过压力检测套囊并结扎断端,用注射器向压力检测套囊内注入一定量的水后,分别向实验肠管内注入气体、液体、半流体和固体肠内容物模型,PCLAB-UE生物医学信号采集处理系统实时记录肠腔内压力和套囊压力变化。
3、统计分析：记录注入四种不同类型的模拟肠内容物时压力检测套囊压力,所有数据采用SPSS13.0统计软件进行分析,数据用x±s表示,分别对4种肠内容物模型组的肠管压力与套囊压力进行相关性分析。
4、构建压力反馈式人工肛门压力检测系统：根据压力传感器的技术参数制作调理电路,将压力传感器实时采集的肠管压力信号转换为电信号反馈给中央控制系统,中央控制系统将传人的实时肠管压力和预先设定的报警压力阈值进行比对,当达到阈值时中央控制系统驱动蜂鸣器报警,提醒患者排便。
二、人工肛门括约肌系统的研制
1、人工肛门括约肌套囊的制作：分别制作圆柱形和“L”形两种人工肛门括约肌套囊,将柔软的硅胶薄膜管放入刚性的聚乙烯管中,再将硅胶管两端反折套在聚乙烯管两端并密封形成封闭的套囊。两种括约肌套囊内壁均为柔软的硅橡胶薄膜,外壁则分别为圆柱形和“L”形两种形状的聚乙烯管,经套囊外壁引出一条与囊腔相通的导水管。
2、两种人工肛门括约肌钳夹压力及肠管渗漏压力关系测定：用三通管将压力传感器、括约肌套囊和注射器连通。将压力传感器接入PCLAB-UE生物医学信号采集处理系统。将实验肠管穿过括约肌套囊,分别向人工肛门括约肌套囊内注入水,使人工肛门括约肌套囊压力维持在不同水平；再将生理盐水注入肠管模拟肠内容物形成,分别记录不同括约肌钳夹压力下肠管出现渗漏时的肠管压力。
3、统计分析：分别记录两种人工肛门括约肌套囊在不同钳夹压力和该钳夹压力下肠管出现渗漏时的肠腔内压力,所有数据采用SPSS13.0统计软件进行分析,数据用牙±s表示,比较两种人工肛门括约肌控制排便的效果。
4、人工肛门括约肌压力检测模块的构建：将压力传感器通过三通管与括约肌套囊连通以检测括约肌压力,将压力传感器输出的差分信号,经过滤波、放大及信号隔离等调理电路处理传送至中央处理器A/D转换模块。
5、括约肌水泵控制模块的构建：选用小功率微型齿轮泵,利用L293D电机驱动芯片搭建H桥型电机驱动电路,将电机转动方向控制信号机使能信号与中央处理器I/O管脚相连,通过控制中央处理器相应管脚输出信号高低电平控制电机转动方向控制信号机使能信号,从而控制电机正反转及停机。
三、智能人工肛门括约肌系统的构建及其作用观察
1、液晶显示模块、矩阵键盘模块、中央处理器模块、报警、按键及电源模块的构建：采用LCD1602作为液晶显示模块实时显示肠管压力及相关报警提示信息;采用4*4矩阵式键盘,利用键盘扫描芯片MM74C922搭建矩阵键盘驱动电路,实现便捷快速输入系统相关参数信息；选用ARM-Cortex-M3作为中央处理器,利用蜂鸣器实现报警功能；采用两路独立按键及三路独立LED实现物理控制及系统工作状态显示功能。
2、系统各模块软件设计及实现：根据系统功能要求,采用结构化软件设计方法,将系统软件分为肠管压力A/D采样模块、水泵控制模块、液晶显示模块、键盘输入模块等四大功能模块,基于C语言在IAR编译器环境中编译及调试。
3、智能人工肛门括约肌系统控制排便作用观察：根据前期实验结果设置压力检测和压力检测套囊的注水量和报警阈值,以及人工括约肌套囊的钳夹压力。向实验肠管注入生理盐水模拟大便的形成,观察智能人工肛门括约肌系统控制排便效果。
结果
一、生物反馈式人工肛门感知系统的研制
1、制作了人工肛门压力检测套囊,该套囊由柔软的硅胶薄膜内壁和刚性的聚乙烯管外壁密封而成,套囊外壁有导水管与压力传感器连通。肠内容物形成时扩张肠管挤压套囊内壁,压力通过囊腔内的水传导至压力传感器。
2、将压力传感器和压力检测套囊结合,根据实验结果和设备参数制作调理电路,通过A/D采样实时获取压力信息,建立了压力反馈式人工肛门压力检测和反馈系统。
3、压力检测套囊压力随着模拟肠内容物量的增加和肠管内压力的增大而增大,压力检测套囊压力与肠内容物体积和肠管压力之间成正相关[气体(R2=0.981,P<0.001)、液体(R2=0.981,P<0.001)、半流体(R2=0.981,P<0.001)和固体(R2=0.981,P<0.001)]。
二、人工肛门括约肌执行机构的研制
1、制作了圆柱形和“L”形两种人工肛门括约肌套囊,该套囊由柔韧的硅胶薄膜内壁和刚性的聚乙烯管外壁密封而成,套囊外壁有导水管与压力传感器和双向水泵连通,用于压力检测和注/排水。
2、将压力传感器和括约肌套囊结合,根据设备参数制作调理电路,通过A/D采样实时获取压力信息,建立了人工肛门压力检测系统。该系统能检测并反馈括约肌压力,为系统自动精确调节括约肌压力提供可能。
3、根据微型齿轮泵参数设计电机驱动电路,通过中央处理器控制水泵正转、反转或停机等工作状态,向括约肌套囊内注水或排水,使括约肌收缩或舒张,从而实现对排便的控制。
4、括约肌的钳夹压力随着注入人工肛门括约肌套囊水量的增加而增大,肠管出现渗漏时的肠管内压也随之增大。当括约肌压力为30mmHg时,圆柱形组和“L”形组的肠管渗漏压力分别为(32.42±1.87)mmHg和(37.42±1.34)mmHg;当括约肌压力为45mmHg时,圆柱形组和“L”形组的肠管渗漏压力分别为(51.16±2.22) mmHg和(58.16±0.90) mmHg;当括约肌压力为60mmHg时,圆柱形组和“L”形组的肠管渗漏压力分别为(75.26±3.74)mmHg和(83.26±2.08) mmHg;当括约肌压力为70mmHg时,圆柱形组和“L”形组的肠管渗漏压力分别为(98.75±4.27) mmHg和(113.66±4.06) mmHg。三、智能人工肛门括约肌系统的构建及作用观察
1、中央处理器模块的构建、液晶显示模块的构建、矩阵键盘模块的构建、报警、按键、LED及电源模块的构建：选用ARM-Cortex-M3系列LM3S8962作为中央处理器,搭建中央处理器最小系统；采用LCD1602实时显示压力信息；采用4*4矩阵式键盘便捷输入系统参数信息；通过蜂鸣实现系统报警功能；设计两路独立按键及三路独立LED实现系统物理控制及系统工作状态显示。
2、根据前期试验结果,将压力反馈模块的报警阈值设定为34.31mmHg,括约肌套囊钳夹压力设定为60mmHg,对应的肠管内压力和渗漏压力分别为60mmHg和83.26mmHg。压力检测和反馈系统实时检测和反馈肠管压力,液晶显示器实时显示肠管压力,当反馈压力达到阈值时,蜂鸣器报警；人工括约肌在人为控制下可实现自动开合控制排便,并能在中央控制系统的调控下精确控制括约肌压力。
结论
一、生物反馈式人工肛门感知系统的研制
利用自制的压力检测套囊和压力传感器及其调理电路所研制的生物反馈式人工肛门感知系统能有效的感知和反馈肠内压的变化和肠内容物的多少,重建了肠管对肠内容物的感知功能,为原位植入式智能人工肛门括约肌系统感知和反馈功能的研究奠定理论基础。
二、人工肛门括约肌执行机构的研制
圆柱形和“L”形人工肛门括约肌均能有效的控制排便。比较两种人工肛门括约肌控制排便的效果可见,在相同钳夹压力下“L”形人工肛门括约肌钳制的肠管渗漏压较圆柱形括约肌钳制的肠管渗漏压大。符合人体解剖学原理“L”形人工肛门括约肌能模拟肛管直肠角的形成,其控制排便的效果优于圆柱形人工肛门括约肌。
三、智能人工肛门括约肌系统的构建及作用观察
构建并集成各模块研制智能人工肛门括约肌系统。实验结果表明,人工肛门括约肌压力反馈系统能有效的感知反馈肠内容物的多少和肠内压的变化；人工肛门控制系统能够根据预先设定的程序自动精确调节“L”形人工肛门括约肌的压力,在使用者的控制下实现自动开放和关闭,不仅能有效的节制排便,还能降低因长时间高压带导致的缺血缺氧性并发症。创新
1、利用自制压力检测套囊和压力传感器研制出生物反馈式人工肛门感知系统,重建了肠管对肠内容物的感知功能,该生物反馈式人工肛门感知系统能有效的感知和反馈肠内压的变化和肠内容物的多少,为原位植入式智能人工肛门括约肌系统感知和反馈功能的研究奠定理论基础。
2、根据人体解剖学和排便控制原理首次研制出“L”形人工肛门括约肌,通过模拟耻骨直肠肌的作用使所钳夹的肠管成角弯曲模拟肛管直肠角的形成,提升了人工括约肌控制排便的效果,使其可以在较小钳夹压力下实现控制排便的功能,进而有效的减少因压迫肠管所致的各种并发症。
3、首次将压力传感器和双向水泵与人工肛门括约肌套囊整合构建人工肛门括约肌智能控制系统,使人工肛门括约肌的自动控制成为了可能。同时,该系统可以不影响控制排便的情况下,根据肠管压力的大小调节钳夹套囊的钳夹压力,避免了括约肌一直处于高压状态,从而可以减少长时间高压作用于肠管造成的缺血缺氧性损伤。
4、运用单片机将人工肛门括约肌各模块集成研制的智能人工肛门括约肌系统,能自动收集和处理相关信息,并在使用者的操控下控制人工肛门括约肌各系统协调运作,具有智能、人性化和操作简便的特点,为智能人工肛门括约肌的研制奠定了理论基础。
Background
Faecal incontinence is the involuntary loss of liquid or solid stool and continued for more than one month. The main clinical manifestations of FI is inability to control bowel movements or leaking stool which is one of the common diseases of anorectal surgery. Studies have shown that the incidence of faecal incontinence in adults was5%to10%, with1%to2%experiencing significant impact on daily activities. There is a higher incidence of fecal incontinence in the elderly, women, and frail people. It becomes more common with advancing age and disability. Faecal incontinence is a social or hygienic problem which has a major negative impact on physical and psychological health and lifestyle, many sufferers feel that is particularly embarrassing and socially unacceptable, and do not seek professional treatment.
There are multiple reasons could lead to fecal incontinence, including obstetric or other trauma, or a congenital abnormality of one or both of the anal sphincters or the pelvic floor muscles; neurological disease or injury causing sensory or motor impairment to the continence mechanism; local anorectal pathology; rectal loading and subsequent "overflow" leakage in frail or immobile individuals; and physical or mental disabilities affecting toilet habits. With the increase of fecal incontinence incidence, the study on fecal incontinence is gradually increasing and many treatments were applied to treat fecal incontinence, such as biofeedback training, pelvic floor muscle strengthening treatment, electrical stimulation of sacral nerve and reconstruction of autologous tissue of the anal sphincter. These treatments received a certain effects on incomplete fecal incontinence, but the fully fecal incontinence, such as the rectum low tumor that the anal sphincter and peripheral nerve were completely damaged is lack of effective treatment methods. Successful application of artificial urinary sphincter in the treatment of urinary incontinence provides a new strategy for the treatment of fecal incontinence. The application of artificial anal sphincter has made some patients regain the ability to control defecation. However, the existing artificial anal sphincter still have some limitations, such as lack of perception and feedback, hypoxic ischemic complications caused by the oppression of the artificial anal sphincter, complicated implant surgery, and inconvenient to use that limit the promotion and application of artificial anal sphincter.
Objective:
For these reasons, according to the defects of the existing artificial anus and the human body defecation principle, we use biomedical engineering technology to look forward to developing a highly integrated in situ intelligent artificial anal sphincter system and lay the foundation for the development and application of the artificial anus. And the situ intelligent artificial anal sphincter system has the function of perception and feedback, can effectively control stool outflow, convenient to use, with good biocompatibility.
Method
1. Development of biofeedback artificial anal sphincter perceptual system
1.1Study on the manufacture of the artificial anal sphincter pressure acquisition cuff
The artificial anal sphincter pressure acquisition cuff was made base on the Artificial Anal Sphincter and rectal physiology, put the soft silicone membrane tube into the rigid polyethylene pipe, then reflex both ends of the silicone tube, cover and stick on both ends of polyethylene pipe to form a closed set of capsule. An aqueduct was lead from the outer wall of the cuff which connected with the cavity of cuff.
1.2Determine the relationship of pressure between the intestinal and acquisition cuff
Connecting the pressure sensors, pressure acquisition cuff and syringe with three-way pipe, then connecting the pressure sensors to PCLAB-UE biomedical signal acquisition and processing system. Twenty healthy New Zealand rabbits were used to test its feasibility, and the experiments were performed on the distal part of proximal colon of the rabbits. The pressure of colon and pressure acquisition cuff were measured after injecting four states simulation intestinal contents of gas, liquid, semi-fluid, solid into the colon respectively, and the relationship between the volume of the four states of intestinal contents and the intestinal pressure and the cuff pressure was analyzed.
1.3Statistical analysis
Record the pressure of the experimental bowel and pressure acquisition cuff while injecting four different types of simulated intestinal contents, and all data was analyzed and tested with SPSS13.0statistical software, and analysis the correlation of the pressure between the experimental bowel and pressure acquisition cuff respectively.
1.4Study on the establishment of the pressure acquisition and feedback system
Make use of pressure sensor to collect the real-time pressure of acquisition bowel, and the pressure signals were converted to electrical signals and send to the central control system which comparison of intestinal real-time pressure and preset threshold pressure. When the pressure reach to the threshold the central control system drive buzzer alarm to remind patients to defecate.
2. Study on the manufacture of artificial anal sphincter system
2.1Manufacture of artificial anal sphincter cuff
We designed cylindrical and L-shaped with pressure sensor artificial anal sphincter. The inner wall of artificial anal sphincter was made by soft silicone membrane and the outer wall was made by cylindrical and L-shaped rigid polyethylene pipe. An aqueduct was lead from the outer wall of the cuff which connected with the cavity of cuff.
2.2Determine the relationship of pressure between the artificial anal sphincter and bowel when it leakage
Connecting the pressure sensor, artificial anal sphincter cuff and syringe with three-way pipe, then connecting the pressure sensor to PCLAB-UE biomedical signal acquisition and processing system. Twenty healthy New Zealand rabbits were used to test and compare the two artificial anal sphincters' bowel-restrained function, and the experiments were performed on the distal part of proximal colon of the rabbits. Put the experimental bowel into through the pressure acquisition cuff, and inject water into the artificial anal sphincter cuff to control the bowel leakage, and maintain the artificial anal sphincter cuff pressure at different levels. Then inject saline into the experimental bowel to simulate formation of stool, and record the pressure of the bowel when it leakage.
2.3Statistical analysis
Record the pressure of two types of artificial anal sphincter cuff and that of the experimental bowel when it leakage and all data was analyzed and tested with SPSS13.0statistical software.
2.4Study on the establishment of artificial anal sphincter pressure detection module
Connecting the pressure sensor, artificial anal sphincter cuff and syringe with three-way pipe, the difference signal output from the pressure sensor was processed by the filtering, amplification and signal isolation conditioning circuit, and then lead to central processor A/D converter module to acquisition real-time sphincter pressure.
2.5Study on establishment of pump control module of artificial anal sphincter
The pump control module of artificial anal sphincter consists of low-power micro gear pump and its drive circuit. The central processor of drive circuit can drive the pump forward, backward and shutdown so as to control the artificial anal sphincter expansion and contraction.3. Study on the establishment of situ intelligent artificial anal sphincter system and observation on its efficacy
3.1Study on the establishment of LCD module, matrix keyboard module, central processor module, and alarm, keys and power modules
We make use of LCD1602to establish LCD module to display the intestinal pressure and alarm information,4*4matrix keyboard and MM74C922keyboard scanning chip to establish matrix keyboard module to set the parameters, ARM-Cortex-M3chip to establish central processor module, and buzzer to establish alarm module.
3.2Design and implementation of the each system module software
According to the requirements of the system function, the system software was divided into four functional modules:bowel pressure A/D sampling module, pump control module, LCD module, keyboard input module. And the system software was compiled and debuged in the IAR compiler environment based on the C language.
3.3Observation of the intelligent artificial anal sphincters'bowel-restrained function
Set the alarm threshold and the artificial anal sphincters'bowel-restrained pressure base on the pre-experiment. The physiological saline was injected into the bowel to simulate the formation of stool, and observe the bowel-restrained function of the intelligent artificial anal sphincters.
Result
1. Development of biofeedback colostomy sensing system
We developed a biofeedback colostomy sensing system with pressure acquisition cuff, pressure sensor and its conditioning circuit. The results of the experiment showed that the pressure of colon and pressure-detection cuff was increased with the increasing of the volume of intestinal contents, the pressure and the volume was positively correlated within a certain range.[Gaseous intestinal contents (R2=0.981, P<0.001),Liquid intestinal contents (R2=0.981, P<0.001), Semi-fluid intestinal contents (R2=0.981, P<0.001), and Solid intestinal contents (R2=0.981, P<0.001)]。
2. Study on the manufacture of artificial anal sphincter
We designed cylindrical and L-shaped with pressure sensor artificial anal sphincter. Twenty healthy New Zealand rabbits were used to test and compare the two artificial anal sphincters' bowel-restrained function, and the experiments were performed on the distal part of proximal colon of the rabbits. The results of the experiment show that when the cylindrical and the L-shaped artificial anal sphincters' bowel-restrained pressure reach to60mmHg, the leakage pressure of bowel under the control of the two anal sphincters are75.26±3.74mmHg and83.26±2.08mmHg.
3. Study on the establishment of situ intelligent artificial anal sphincter system and observation on its efficacy
We established a situ intelligent artificial anal sphincter system, and the system was divided into four functional modules:bowel pressure A/D sampling module, pump control module, LCD module, keyboard input module. The function of the intelligent artificial anal sphincter system was assessed in vitro and in vivo in New Zealand rabbits. The pressure of the feedback cuff was positively correlated with the pressure and the volume of the bowel within a certain range, the pressure feedback system able to reflect the change of the intra-intestinal pressure effectively. And the L-style artificial anal sphincter is available for the control of fecal incontinence under the control of chip microcomputer.
Conclusion
1. Development of biofeedback colostomy sensing system
According to experiment, the bio-feedback artificial anal sphincter perceptual system could effectively reflect the change of intestinal pressure and the volume of intestinal contents, and maybe a effective strategy to address the awareness and feedback problem of artificial anal sphincter, so as to lay the basis for the research of intelligent bio-feedback artificial anal sphincter.
2. Study on the manufacture of artificial anal sphincter
According to experiment, the two artificial anal sphincters are available for the control of fecal incontinence, and the L-shaped artificial anal sphincter is better than cylindrical artificial anal sphincter. It is concluded that with pressure feedback function and ergonomically designed artificial anal sphincter could provide a new reference to solve the complication because of the oppression.
3. Study on the establishment of situ intelligent artificial anal sphincter system and observation on its efficacy
The results indicated that the IAAS could efficiently maintain continence and reflect the change of the intra-intestinal pressure, and lay a basis for the research of intelligent artificial anal sphincter.
大便失禁(fecal incontinence, FI)是指由各种原因所致的不能自主控制液体或固体大便排出,并持续一个月以上。临床上主要表现为排便不能控制,是肛肠外科常见的疾病之一。研究表明成年人大便失禁的发生率从5%-10%不等,其中1%-2%的患者的工作和生活受到了重大影响。大便失禁是一个卫生学和社会学问题,给患者的身心造成了极大的痛苦。由于大便失禁的特殊性,相当一部分患者因感到难以启齿和不被社会接受而选择放弃寻求专业治疗。引起大便失禁的原因很多,包括解剖结构、生理状态或精神社会因素等的异常,如括约肌和／或盆底肌先天性畸形、神经系统疾病、直肠低位肿瘤、外伤和产伤等。可以预见,随着直肠低位肿瘤发病率的升高、寿命的延长以及精神心理状态的下降,大便失禁的发生率也将随之升高。
随着的大便失禁发病率的升高,使其受到越来越多的重视,对大便失禁的研究也逐渐增多,越来越多的治疗方法应用于临床,比如生物反馈治疗、直肠敏感性训练、骶神经电刺激以及自体组织重建肛门,虽然现有的这些内、外科治疗对轻度不完全性的大便失禁有着一定的疗效,但是对于某些原因(如直肠低位肿瘤)所致的肛门括约肌及其周围神经完全性损毁造成的完全性大便失禁的治疗却并不理想。人工尿道括约肌在治疗尿失禁中的成功应用,为人工肛门括约肌治疗大便失禁提供了一条崭新的策略。人工肛门括约肌的研究和应用使部分病人重新获得了控制排便的能力。然而,现有的人工肛门括约肌却存在诸如缺乏感知和反馈,压迫肠管导致缺血缺氧性并发症,植入手术复杂,操作不便等诸多缺陷,以至于限制了人工肛门括约肌的推广和应用。
研究目的
基于上述原因,本研究拟针对现有人工肛门存在的缺陷,根据人体解剖学和排便控制原理,运用生物医学工程学技术,研制一种具有感知和反馈功能的,符合人体解剖学原理的,能有效控制大便流出的,高度集成使用方便的原位植入式智能人工肛门系统,为人工肛门的研究和应用奠定基础。
方法
一、生物反馈式人工肛门感知系统的研制
1、人工肛门压力检测套囊的制作：人工肛门压力检测套囊为一独立的套囊,将柔软的硅胶薄膜管放入刚性的聚乙烯管中,再将硅胶薄膜管两端反折套在聚乙烯管两端并密封形成封闭的套囊,经套囊外壁引出一条与囊腔相通的导水管。
2、肠腔内压与压力检测套囊压力关系测定：用三通管将压力传感器、压力检测套囊和注射器连通,压力传感器接入PCLAB-UE生物医学信号采集处理系统。将实验肠管穿过压力检测套囊并结扎断端,用注射器向压力检测套囊内注入一定量的水后,分别向实验肠管内注入气体、液体、半流体和固体肠内容物模型,PCLAB-UE生物医学信号采集处理系统实时记录肠腔内压力和套囊压力变化。
3、统计分析：记录注入四种不同类型的模拟肠内容物时压力检测套囊压力,所有数据采用SPSS13.0统计软件进行分析,数据用x±s表示,分别对4种肠内容物模型组的肠管压力与套囊压力进行相关性分析。
4、构建压力反馈式人工肛门压力检测系统：根据压力传感器的技术参数制作调理电路,将压力传感器实时采集的肠管压力信号转换为电信号反馈给中央控制系统,中央控制系统将传人的实时肠管压力和预先设定的报警压力阈值进行比对,当达到阈值时中央控制系统驱动蜂鸣器报警,提醒患者排便。
二、人工肛门括约肌系统的研制
1、人工肛门括约肌套囊的制作：分别制作圆柱形和“L”形两种人工肛门括约肌套囊,将柔软的硅胶薄膜管放入刚性的聚乙烯管中,再将硅胶管两端反折套在聚乙烯管两端并密封形成封闭的套囊。两种括约肌套囊内壁均为柔软的硅橡胶薄膜,外壁则分别为圆柱形和“L”形两种形状的聚乙烯管,经套囊外壁引出一条与囊腔相通的导水管。
2、两种人工肛门括约肌钳夹压力及肠管渗漏压力关系测定：用三通管将压力传感器、括约肌套囊和注射器连通。将压力传感器接入PCLAB-UE生物医学信号采集处理系统。将实验肠管穿过括约肌套囊,分别向人工肛门括约肌套囊内注入水,使人工肛门括约肌套囊压力维持在不同水平；再将生理盐水注入肠管模拟肠内容物形成,分别记录不同括约肌钳夹压力下肠管出现渗漏时的肠管压力。
3、统计分析：分别记录两种人工肛门括约肌套囊在不同钳夹压力和该钳夹压力下肠管出现渗漏时的肠腔内压力,所有数据采用SPSS13.0统计软件进行分析,数据用牙±s表示,比较两种人工肛门括约肌控制排便的效果。
4、人工肛门括约肌压力检测模块的构建：将压力传感器通过三通管与括约肌套囊连通以检测括约肌压力,将压力传感器输出的差分信号,经过滤波、放大及信号隔离等调理电路处理传送至中央处理器A/D转换模块。
5、括约肌水泵控制模块的构建：选用小功率微型齿轮泵,利用L293D电机驱动芯片搭建H桥型电机驱动电路,将电机转动方向控制信号机使能信号与中央处理器I/O管脚相连,通过控制中央处理器相应管脚输出信号高低电平控制电机转动方向控制信号机使能信号,从而控制电机正反转及停机。
三、智能人工肛门括约肌系统的构建及其作用观察
1、液晶显示模块、矩阵键盘模块、中央处理器模块、报警、按键及电源模块的构建：采用LCD1602作为液晶显示模块实时显示肠管压力及相关报警提示信息;采用4*4矩阵式键盘,利用键盘扫描芯片MM74C922搭建矩阵键盘驱动电路,实现便捷快速输入系统相关参数信息；选用ARM-Cortex-M3作为中央处理器,利用蜂鸣器实现报警功能；采用两路独立按键及三路独立LED实现物理控制及系统工作状态显示功能。
2、系统各模块软件设计及实现：根据系统功能要求,采用结构化软件设计方法,将系统软件分为肠管压力A/D采样模块、水泵控制模块、液晶显示模块、键盘输入模块等四大功能模块,基于C语言在IAR编译器环境中编译及调试。
3、智能人工肛门括约肌系统控制排便作用观察：根据前期实验结果设置压力检测和压力检测套囊的注水量和报警阈值,以及人工括约肌套囊的钳夹压力。向实验肠管注入生理盐水模拟大便的形成,观察智能人工肛门括约肌系统控制排便效果。
结果
一、生物反馈式人工肛门感知系统的研制
1、制作了人工肛门压力检测套囊,该套囊由柔软的硅胶薄膜内壁和刚性的聚乙烯管外壁密封而成,套囊外壁有导水管与压力传感器连通。肠内容物形成时扩张肠管挤压套囊内壁,压力通过囊腔内的水传导至压力传感器。
2、将压力传感器和压力检测套囊结合,根据实验结果和设备参数制作调理电路,通过A/D采样实时获取压力信息,建立了压力反馈式人工肛门压力检测和反馈系统。
3、压力检测套囊压力随着模拟肠内容物量的增加和肠管内压力的增大而增大,压力检测套囊压力与肠内容物体积和肠管压力之间成正相关[气体(R2=0.981,P<0.001)、液体(R2=0.981,P<0.001)、半流体(R2=0.981,P<0.001)和固体(R2=0.981,P<0.001)]。
二、人工肛门括约肌执行机构的研制
1、制作了圆柱形和“L”形两种人工肛门括约肌套囊,该套囊由柔韧的硅胶薄膜内壁和刚性的聚乙烯管外壁密封而成,套囊外壁有导水管与压力传感器和双向水泵连通,用于压力检测和注/排水。
2、将压力传感器和括约肌套囊结合,根据设备参数制作调理电路,通过A/D采样实时获取压力信息,建立了人工肛门压力检测系统。该系统能检测并反馈括约肌压力,为系统自动精确调节括约肌压力提供可能。
3、根据微型齿轮泵参数设计电机驱动电路,通过中央处理器控制水泵正转、反转或停机等工作状态,向括约肌套囊内注水或排水,使括约肌收缩或舒张,从而实现对排便的控制。
4、括约肌的钳夹压力随着注入人工肛门括约肌套囊水量的增加而增大,肠管出现渗漏时的肠管内压也随之增大。当括约肌压力为30mmHg时,圆柱形组和“L”形组的肠管渗漏压力分别为(32.42±1.87)mmHg和(37.42±1.34)mmHg;当括约肌压力为45mmHg时,圆柱形组和“L”形组的肠管渗漏压力分别为(51.16±2.22) mmHg和(58.16±0.90) mmHg;当括约肌压力为60mmHg时,圆柱形组和“L”形组的肠管渗漏压力分别为(75.26±3.74)mmHg和(83.26±2.08) mmHg;当括约肌压力为70mmHg时,圆柱形组和“L”形组的肠管渗漏压力分别为(98.75±4.27) mmHg和(113.66±4.06) mmHg。三、智能人工肛门括约肌系统的构建及作用观察
1、中央处理器模块的构建、液晶显示模块的构建、矩阵键盘模块的构建、报警、按键、LED及电源模块的构建：选用ARM-Cortex-M3系列LM3S8962作为中央处理器,搭建中央处理器最小系统；采用LCD1602实时显示压力信息；采用4*4矩阵式键盘便捷输入系统参数信息；通过蜂鸣实现系统报警功能；设计两路独立按键及三路独立LED实现系统物理控制及系统工作状态显示。
2、根据前期试验结果,将压力反馈模块的报警阈值设定为34.31mmHg,括约肌套囊钳夹压力设定为60mmHg,对应的肠管内压力和渗漏压力分别为60mmHg和83.26mmHg。压力检测和反馈系统实时检测和反馈肠管压力,液晶显示器实时显示肠管压力,当反馈压力达到阈值时,蜂鸣器报警；人工括约肌在人为控制下可实现自动开合控制排便,并能在中央控制系统的调控下精确控制括约肌压力。
结论
一、生物反馈式人工肛门感知系统的研制
利用自制的压力检测套囊和压力传感器及其调理电路所研制的生物反馈式人工肛门感知系统能有效的感知和反馈肠内压的变化和肠内容物的多少,重建了肠管对肠内容物的感知功能,为原位植入式智能人工肛门括约肌系统感知和反馈功能的研究奠定理论基础。
二、人工肛门括约肌执行机构的研制
圆柱形和“L”形人工肛门括约肌均能有效的控制排便。比较两种人工肛门括约肌控制排便的效果可见,在相同钳夹压力下“L”形人工肛门括约肌钳制的肠管渗漏压较圆柱形括约肌钳制的肠管渗漏压大。符合人体解剖学原理“L”形人工肛门括约肌能模拟肛管直肠角的形成,其控制排便的效果优于圆柱形人工肛门括约肌。
三、智能人工肛门括约肌系统的构建及作用观察
构建并集成各模块研制智能人工肛门括约肌系统。实验结果表明,人工肛门括约肌压力反馈系统能有效的感知反馈肠内容物的多少和肠内压的变化；人工肛门控制系统能够根据预先设定的程序自动精确调节“L”形人工肛门括约肌的压力,在使用者的控制下实现自动开放和关闭,不仅能有效的节制排便,还能降低因长时间高压带导致的缺血缺氧性并发症。创新
1、利用自制压力检测套囊和压力传感器研制出生物反馈式人工肛门感知系统,重建了肠管对肠内容物的感知功能,该生物反馈式人工肛门感知系统能有效的感知和反馈肠内压的变化和肠内容物的多少,为原位植入式智能人工肛门括约肌系统感知和反馈功能的研究奠定理论基础。
2、根据人体解剖学和排便控制原理首次研制出“L”形人工肛门括约肌,通过模拟耻骨直肠肌的作用使所钳夹的肠管成角弯曲模拟肛管直肠角的形成,提升了人工括约肌控制排便的效果,使其可以在较小钳夹压力下实现控制排便的功能,进而有效的减少因压迫肠管所致的各种并发症。
3、首次将压力传感器和双向水泵与人工肛门括约肌套囊整合构建人工肛门括约肌智能控制系统,使人工肛门括约肌的自动控制成为了可能。同时,该系统可以不影响控制排便的情况下,根据肠管压力的大小调节钳夹套囊的钳夹压力,避免了括约肌一直处于高压状态,从而可以减少长时间高压作用于肠管造成的缺血缺氧性损伤。
4、运用单片机将人工肛门括约肌各模块集成研制的智能人工肛门括约肌系统,能自动收集和处理相关信息,并在使用者的操控下控制人工肛门括约肌各系统协调运作,具有智能、人性化和操作简便的特点,为智能人工肛门括约肌的研制奠定了理论基础。
Background
Faecal incontinence is the involuntary loss of liquid or solid stool and continued for more than one month. The main clinical manifestations of FI is inability to control bowel movements or leaking stool which is one of the common diseases of anorectal surgery. Studies have shown that the incidence of faecal incontinence in adults was5%to10%, with1%to2%experiencing significant impact on daily activities. There is a higher incidence of fecal incontinence in the elderly, women, and frail people. It becomes more common with advancing age and disability. Faecal incontinence is a social or hygienic problem which has a major negative impact on physical and psychological health and lifestyle, many sufferers feel that is particularly embarrassing and socially unacceptable, and do not seek professional treatment.
There are multiple reasons could lead to fecal incontinence, including obstetric or other trauma, or a congenital abnormality of one or both of the anal sphincters or the pelvic floor muscles; neurological disease or injury causing sensory or motor impairment to the continence mechanism; local anorectal pathology; rectal loading and subsequent "overflow" leakage in frail or immobile individuals; and physical or mental disabilities affecting toilet habits. With the increase of fecal incontinence incidence, the study on fecal incontinence is gradually increasing and many treatments were applied to treat fecal incontinence, such as biofeedback training, pelvic floor muscle strengthening treatment, electrical stimulation of sacral nerve and reconstruction of autologous tissue of the anal sphincter. These treatments received a certain effects on incomplete fecal incontinence, but the fully fecal incontinence, such as the rectum low tumor that the anal sphincter and peripheral nerve were completely damaged is lack of effective treatment methods. Successful application of artificial urinary sphincter in the treatment of urinary incontinence provides a new strategy for the treatment of fecal incontinence. The application of artificial anal sphincter has made some patients regain the ability to control defecation. However, the existing artificial anal sphincter still have some limitations, such as lack of perception and feedback, hypoxic ischemic complications caused by the oppression of the artificial anal sphincter, complicated implant surgery, and inconvenient to use that limit the promotion and application of artificial anal sphincter.
Objective:
For these reasons, according to the defects of the existing artificial anus and the human body defecation principle, we use biomedical engineering technology to look forward to developing a highly integrated in situ intelligent artificial anal sphincter system and lay the foundation for the development and application of the artificial anus. And the situ intelligent artificial anal sphincter system has the function of perception and feedback, can effectively control stool outflow, convenient to use, with good biocompatibility.
Method
1. Development of biofeedback artificial anal sphincter perceptual system
1.1Study on the manufacture of the artificial anal sphincter pressure acquisition cuff
The artificial anal sphincter pressure acquisition cuff was made base on the Artificial Anal Sphincter and rectal physiology, put the soft silicone membrane tube into the rigid polyethylene pipe, then reflex both ends of the silicone tube, cover and stick on both ends of polyethylene pipe to form a closed set of capsule. An aqueduct was lead from the outer wall of the cuff which connected with the cavity of cuff.
1.2Determine the relationship of pressure between the intestinal and acquisition cuff
Connecting the pressure sensors, pressure acquisition cuff and syringe with three-way pipe, then connecting the pressure sensors to PCLAB-UE biomedical signal acquisition and processing system. Twenty healthy New Zealand rabbits were used to test its feasibility, and the experiments were performed on the distal part of proximal colon of the rabbits. The pressure of colon and pressure acquisition cuff were measured after injecting four states simulation intestinal contents of gas, liquid, semi-fluid, solid into the colon respectively, and the relationship between the volume of the four states of intestinal contents and the intestinal pressure and the cuff pressure was analyzed.
1.3Statistical analysis
Record the pressure of the experimental bowel and pressure acquisition cuff while injecting four different types of simulated intestinal contents, and all data was analyzed and tested with SPSS13.0statistical software, and analysis the correlation of the pressure between the experimental bowel and pressure acquisition cuff respectively.
1.4Study on the establishment of the pressure acquisition and feedback system
Make use of pressure sensor to collect the real-time pressure of acquisition bowel, and the pressure signals were converted to electrical signals and send to the central control system which comparison of intestinal real-time pressure and preset threshold pressure. When the pressure reach to the threshold the central control system drive buzzer alarm to remind patients to defecate.
2. Study on the manufacture of artificial anal sphincter system
2.1Manufacture of artificial anal sphincter cuff
We designed cylindrical and L-shaped with pressure sensor artificial anal sphincter. The inner wall of artificial anal sphincter was made by soft silicone membrane and the outer wall was made by cylindrical and L-shaped rigid polyethylene pipe. An aqueduct was lead from the outer wall of the cuff which connected with the cavity of cuff.
2.2Determine the relationship of pressure between the artificial anal sphincter and bowel when it leakage
Connecting the pressure sensor, artificial anal sphincter cuff and syringe with three-way pipe, then connecting the pressure sensor to PCLAB-UE biomedical signal acquisition and processing system. Twenty healthy New Zealand rabbits were used to test and compare the two artificial anal sphincters' bowel-restrained function, and the experiments were performed on the distal part of proximal colon of the rabbits. Put the experimental bowel into through the pressure acquisition cuff, and inject water into the artificial anal sphincter cuff to control the bowel leakage, and maintain the artificial anal sphincter cuff pressure at different levels. Then inject saline into the experimental bowel to simulate formation of stool, and record the pressure of the bowel when it leakage.
2.3Statistical analysis
Record the pressure of two types of artificial anal sphincter cuff and that of the experimental bowel when it leakage and all data was analyzed and tested with SPSS13.0statistical software.
2.4Study on the establishment of artificial anal sphincter pressure detection module
Connecting the pressure sensor, artificial anal sphincter cuff and syringe with three-way pipe, the difference signal output from the pressure sensor was processed by the filtering, amplification and signal isolation conditioning circuit, and then lead to central processor A/D converter module to acquisition real-time sphincter pressure.
2.5Study on establishment of pump control module of artificial anal sphincter
The pump control module of artificial anal sphincter consists of low-power micro gear pump and its drive circuit. The central processor of drive circuit can drive the pump forward, backward and shutdown so as to control the artificial anal sphincter expansion and contraction.3. Study on the establishment of situ intelligent artificial anal sphincter system and observation on its efficacy
3.1Study on the establishment of LCD module, matrix keyboard module, central processor module, and alarm, keys and power modules
We make use of LCD1602to establish LCD module to display the intestinal pressure and alarm information,4*4matrix keyboard and MM74C922keyboard scanning chip to establish matrix keyboard module to set the parameters, ARM-Cortex-M3chip to establish central processor module, and buzzer to establish alarm module.
3.2Design and implementation of the each system module software
According to the requirements of the system function, the system software was divided into four functional modules:bowel pressure A/D sampling module, pump control module, LCD module, keyboard input module. And the system software was compiled and debuged in the IAR compiler environment based on the C language.
3.3Observation of the intelligent artificial anal sphincters'bowel-restrained function
Set the alarm threshold and the artificial anal sphincters'bowel-restrained pressure base on the pre-experiment. The physiological saline was injected into the bowel to simulate the formation of stool, and observe the bowel-restrained function of the intelligent artificial anal sphincters.
Result
1. Development of biofeedback colostomy sensing system
We developed a biofeedback colostomy sensing system with pressure acquisition cuff, pressure sensor and its conditioning circuit. The results of the experiment showed that the pressure of colon and pressure-detection cuff was increased with the increasing of the volume of intestinal contents, the pressure and the volume was positively correlated within a certain range.[Gaseous intestinal contents (R2=0.981, P<0.001),Liquid intestinal contents (R2=0.981, P<0.001), Semi-fluid intestinal contents (R2=0.981, P<0.001), and Solid intestinal contents (R2=0.981, P<0.001)]。
2. Study on the manufacture of artificial anal sphincter
We designed cylindrical and L-shaped with pressure sensor artificial anal sphincter. Twenty healthy New Zealand rabbits were used to test and compare the two artificial anal sphincters' bowel-restrained function, and the experiments were performed on the distal part of proximal colon of the rabbits. The results of the experiment show that when the cylindrical and the L-shaped artificial anal sphincters' bowel-restrained pressure reach to60mmHg, the leakage pressure of bowel under the control of the two anal sphincters are75.26±3.74mmHg and83.26±2.08mmHg.
3. Study on the establishment of situ intelligent artificial anal sphincter system and observation on its efficacy
We established a situ intelligent artificial anal sphincter system, and the system was divided into four functional modules:bowel pressure A/D sampling module, pump control module, LCD module, keyboard input module. The function of the intelligent artificial anal sphincter system was assessed in vitro and in vivo in New Zealand rabbits. The pressure of the feedback cuff was positively correlated with the pressure and the volume of the bowel within a certain range, the pressure feedback system able to reflect the change of the intra-intestinal pressure effectively. And the L-style artificial anal sphincter is available for the control of fecal incontinence under the control of chip microcomputer.
Conclusion
1. Development of biofeedback colostomy sensing system
According to experiment, the bio-feedback artificial anal sphincter perceptual system could effectively reflect the change of intestinal pressure and the volume of intestinal contents, and maybe a effective strategy to address the awareness and feedback problem of artificial anal sphincter, so as to lay the basis for the research of intelligent bio-feedback artificial anal sphincter.
2. Study on the manufacture of artificial anal sphincter
According to experiment, the two artificial anal sphincters are available for the control of fecal incontinence, and the L-shaped artificial anal sphincter is better than cylindrical artificial anal sphincter. It is concluded that with pressure feedback function and ergonomically designed artificial anal sphincter could provide a new reference to solve the complication because of the oppression.
3. Study on the establishment of situ intelligent artificial anal sphincter system and observation on its efficacy
The results indicated that the IAAS could efficiently maintain continence and reflect the change of the intra-intestinal pressure, and lay a basis for the research of intelligent artificial anal sphincter.
引文
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