人工肛门封堵器结合压力传感器的可行性研究
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摘要
研究背景和目的：
由于结直肠癌等疾病发病率的上升,肠造口术已成为外科最常施行的手术之一,替代了原位肛门,可缓解各种原因引起的排便失禁、排便困难等症状,故称人工肛门。全球每年由于结直肠癌、外伤、炎症及先天性畸形等而需行肠造口术者达数十万人之多,肠造口对患者本人的心理、生理及社会等多方面均产生较大的影响,其主要原因在于：(1)肠造口处排便难以控制,常有粪便漏出,且伴有异味；(2)肠造口处周围皮肤长期受粪便、肠液等刺激,容易并发各类皮炎。目前临床上对于肠造口患者术后护理中,肠造口袋的应用最为广泛,造口袋可防止粪便污染皮肤及异味传播,并对排便进行适当控制,从而改善生活质量。
大便失禁又称肛门失禁,是指持续或反复发作的不能感知肠内容物性质或肠内容物的排出控制障碍,包括固态、液态、气态的肠内容物,是复杂的、多因素导致的排便功能紊乱。国际上对大便失禁的定义为大于3岁的个体,连续或经常不受控制地通过粪便(>10mL),其主要表现为对粪便控制能力的下降,导致排便次数增多,常有腹泻。这些临床症状严重影响患者的日常生活,并给患者带来精神压力。
近年来人们开始研究各种人工肛门封堵装置,以求达到简化操作、控制排便、改善生活质量的目的。研究表明,人工肛门封堵器可有效的封堵肠造口、防止粪便漏出,但泄漏、缺血、感染作为人工肛门封堵器使用时常出现的并发症仍没有办法全部消除。目前已知的人工肛门封堵器均对排便无感知能力,也不能分辨肠内容物性质,只能依靠定时开放封堵装置来控制排便。与此同时,肠造口报警装置的出现,使肠造口封堵器的智能化存在可能。人们通过报警装置,可以感知肠蠕动,进而人为控制排便,但是由于报警装置体积偏大,且肠造口处封堵效果未知,不便于携带的同时,需警惕粪便泄漏产生造口周围感染。目前智能型人工肛门封堵器的相关研究较少,当肠内压力过高时,容易引起造口周围泄漏、感染及造口脱垂等并发症出现；而当肠内压力较低时,开放封堵器进行排便意义不大,且增加开放肠造口次数会给患者生活上带来不便。本实验将压力感应系统与人工肛门封堵器结合起来,通过观察不同肠内压力下同一直径人工肛门封堵器的封堵效果,评估智能型人工肛门封堵器的可行性,以探讨肠内压力与封堵器开放时机的关系,为临床进一步研究和人工肛门封堵器产品提供一定的指导作用。
方法：
1、本实验所用人工肛门封堵器模型由医用有机硅橡胶制成,有机硅橡胶作为传统的生物医学材料,具有良好的生物相容性、耐热、耐老化性能、容易加工成各种形状等优点。模型分为3部分,黏附于造口周围皮肤的基底座、固定于基底座上的封堵塞以及封堵塞头端的球囊组成,基底座胶圈及固定部分均取自Coloplast公司生产的二件式造口袋。封堵器实体部分为圆柱形,从模型内部穿过封堵器放置一橡胶管,连接球囊,将封堵器插入肠造口内,与基底座对合后固定于腹壁上,防止粪便漏出。往橡胶管内注入一定量的水,使得球囊扩张,初始压力调零,当产生肠内容物时,撞击球囊,通过PCLAB-UE生物信号采集处理系统(北京微信思达公司生产,由南方医科大学机能实验室提供)测定肠腔内变化的压力。
2、计算机生物信号采集处理系统是以计算机为核心,结合可扩展的软件技术,集成生物放大器与电刺激器,并且具备图形显示、数据存储、数据处理与分析等功能的电生理学实验设备。其工作基本原理是：首先将原始的生物机能信号,包括生物电信号和通过传感器引入的生物非电信号进行放大、滤波等处理,然后对处理的信号进行模/数(A/D)转换进行数字化,并将数字化后的生物机能信号传输到计算机内部,计算机硬件主要完成对各种生物电信号以及非生物电信号的采集,并对采集到的信号进行调整、放大,进而对信号进行转换,使之进入计算机。软件主要用来对已经数字化了的生物信号进行显示、记录、存储、处理及打印、输出,同时对系统各部分进行控制,使之能与操作者进行对话。
3、压力传感器可以将各种压力变化(如动脉压、经脉压、心室内压、肠内压力等)转换为电信号,然后将这些电信号经过放大输入到记录装置,以便对其所代表的生理变化深入分析,测量范围在-70mmHg-300mmHg。具有精度高、稳定性好；灵敏度高,输出信号大；工作温度范围宽、安全、隔离、防漏等优点。4、随机将实验动物分成三组,动物实验前适应周围环境3天,术前禁食48h,禁水8h,禁食第1天可给予少量葡萄糖液体,第2天严格禁食,完成术前准备后按照腹膜外结肠造口术建立猪肠造口模型。术后第1-3天给予流质饮食,逐步过渡到正常饮食,期间密切观察动物生命体征变化情况,待全身状况稳定后放置封堵器,各组放置封堵器直径一致,每天放置约6-8h,术后测定肠内压力,设定每组开放封堵器的压力分别为5mmHg、10mmHg、15mmHg。根据肠内压力值决定封堵器开放时机,控制排便。
5、感知灵敏度及泄漏率测定：术后第1、4、8周放置封堵器,待达到设定值后打开封堵器,观察是否有肠内容物存在,排空肠内容物后再次置入封堵器,重复观察20次,计算其灵敏度；放置封堵器后,实时监测肠内压力变化,待肠内压力达到预设值时,观察一定时间(约6h)内造口发生泄漏的次数。
应用SPSS13.0统计学软件上进行数据处理,所有数据均以x±s表示,采用多个独立样本非参数检验(Kruskal-Wallis test)比较每个时间点三组间有无显著差异,及多个相关样本的非参数检验(Friedman test),主要是用来检验每组的有无时间效应,上述结果以P<0.05认为差异有统计学意义。
结果：
1、不同肠内压力下智能型人工肛门封堵器感知肠内容物敏感度比较：总体而言,感知灵敏度随肠内压力升高有上升趋势,而当肠内压力达到10mmHg～15mmHg时,术后第4周后人工肛门封堵器结合压力传感器的感知灵敏度在术后各时间段均达到85%以上。各组感知灵敏度的差异并无明显的时间效应(P=0.178、0.670、0.761>0.05),术后第1周、第4周及第8周,各组感知灵敏度有显著性差异(P=0.026、0.034、0.045<0.05),可认为不同肠内压力对感知灵敏度有显著差异,根据平均秩次进一步推断,以15mmHg组感知灵敏度最高,10mmHg组次之,5mmHg组的感知灵敏度相对最低。这可能是由于术后早期,胃肠功能未完全恢复,肠内容物感知敏感程度较低所致。
2、不同肠内压力下智能型人工肛门封堵器泄漏次数比较：各组造口泄漏情况均随着时间进展有减少的趋势,这可能与术后造口直径缩小有一定关系。15mmHg组中各时间段泄漏次数有显著性差异(P=0.050),而5mmHg组及10mmHg组中泄漏次数并无明显时间效应(P=0.080>0.05)。在同一时段,造口泄漏情况与肠内压力成正相关关系,术后第1周,各组在造口泄漏情况差异有统计学意义(P=0.030<0.05),而在术后第4周及第8周,各组在造口泄漏情况无显著性差异。可认为不同肠内压力对造口泄漏率有显著差异,根据平均秩次进一步推断,以15mmHg组造口泄漏次数最多,10mmHg组次之,5mmHg组的造口泄漏次数相对最少。而在术后第4周及第8周,各组在造口泄漏情况无显著性差异(P=0.058、0.051>0.05)。
结论：
1、首次将人工肛门封堵器与压力传感器有机的结合起来,用于小型猪进行动物实验研究,通过测量肠内压力的变化来观察封堵器的封堵效果。
2、肠内压力在10mmHg-15mmHg时,压力传感器感知灵敏度高,此时开放封堵器可较好的进行排便,且不影响封堵效果。
3、该人工肛门封堵器与其他类型封堵装置相比,可更好的固定栓子、且清洗干净后可重复使用；但放置该封堵器易引起肠造口脱垂,且封堵器直径需根据肠造口直径的变化而变化,影响封堵效果。
4、小型猪肠造口模型构建方法有效,术后第8周,小型猪肠造口处排便正常,可更好的模拟人正常排便过程。
Background and objection:
Colostomy is one of the most common surgical procedures available for patients with colorectal cancer (CRC), because of whose incidence rates substantially increases. Colostomy also called artificial anus, which can alternative situ anus, relieve the symptoms of various causes of fecal incontinence and constipation. There are over hundreds of thousands of patients with a sigmoid colostomy because of colorectal cancer, trauma, inflammation and congenital deformity, and stoma-related complications occur frequently creating specific care problem in psychological, physiological, society and may even cause social restrictions and have a major impact on the outcome in term of patients' coping with their new life style, patients with colostomy may suffer incontinence and lack of control over gas and feces that the normal rectal sphincter affords, which complicated by the various types of dermatitis. Colostomy bag is the most widely used for postoperative care of patients with colostomy, which prevent the fecal contaminating peristoma skin and spreading odor, appropriately control defecation, to improve the quality of life (QoL).
Fecal incontinence which is defined as continuous or recurrent uncontrolled passage of fecal material (>10mL) for at least one month in an individual older than three years of age, is the persistent or recurrent can not perceive the shape of the intestinal contents or unable to control the discharge of intestinal contents, including liquid, gaseous, solid intestinal contents, is a complex, multifactorial defecationdysfunction, damage to the ability to control gas or stool, resulting in an increase in the number of bowel movements, often diarrhea. These clinical symptoms seriously affect the patient's daily life, and bring patients to mental stress.
In recent years, people started to study a variety of artificial anus closure device, in order to simplify the operation, control defecation, and improve the quality of life. Reports have shown that artificial anus plugging device can achieve colostomy continence, however, the colostomy fecal leakage, odor, skin infection and other complications cannot eliminate completely. The current known artificial anus plugging device cannot distinguish the nature of the intestinal contents, patients do not know when to evacuate, and they have to establish a bowel habit to defecate after opening the device at regular intervals. Meanwhile, colostomy alarm device provides an apparatus and method for monitoring the presence of fecal mass in a stoma, to control defecation artificially. The volume of alarm device is too large to carry, and the occlusion effect is unknown with high incidence of fecal leakage and peristoma infection, however, the colostomy alarm device provides the possibility of intelligent artificial anus plugging device, which relevant research are not taken seriously. Here we describe an intelligent artificial anus plugging device, which consists of an artificial anus plugging device and pressure sensor, observe the occlusion effect comparison with different intestinal pressure and evaluate the feasibility of intelligent artificial anus plugging device, so as to explore the appropriate timing of the device open for further clinical studies and application provide the basis for intelligent artificial anus plugging device.
Methods and materials:
1. The device is made of silicone rubber, which is a traditional biomedical material with some advantages, such as good biocompatibility, heat and aging resistance, easily processed into a variety of shapes. The plugging device model consisting of an adhesive base plate surrounding the stoma skin, a disposable cylinder colostomy plug and an inflatable balloon located in the head end of the plug. The plug can be applied on colostomies up to4.0cm in diameter. The base plate apron and fixed part are taken from the two-piece colostomy bag produced by Coloplast.
Application of the device is fairly simple. Once the plug is inserted into the colostomy, connected it with base plate fixed in the abdominal wall, inflate the balloon cuff with10mL of water using a20mL plastic syringe, and regulate the initial intestinal pressure. The volume of water to be introduced ranges from10-15mL according to the size of the colon. When stool enters into the colon and strike the inflated balloon, changing intestinal pressure was measured through pressure sensor in vitro.
2. Computer bio-signal collection and processing system based on the computer as the core, combined with the extensible software technology, integrated of biological amplifier with electrical stimulator, and had a graphical display, data storage, data processing and analysis functions electrophysiology laboratory equipment. Hardware mainly to complete a variety of biological electrical signals, such as electrocardiogram (ECG), electromyography (EMG), electroencephalogram (EEG) and non-bio-electrical signals (such as blood pressure, tension, breathing) collection, adjust and amplificate the collected signal, then turn on signal analog/digital (A/D) conversion, and make it into the computer. Software mainly used for displaying, recording, storing, processing, and printing output the biological signal digitized, to controlling the various parts of the system at the same time, to make a dialogue with the operator.
3. The pressure sensor may converted a variety of pressure change (such as arterial pressure, meridians pressure, ventricular pressure, intestinal pressure, etc.) to an electrical signal, and then the electrical signal after amplification inputted to the recording apparatus, so as to analysis the physiological changes that is in a position to represent in-depth. Pressure sensor has some advantages, such as high accuracy, good stability, high sensitivity, output signal; wide operating temperature range, security, isolation, and proof.
4. All animals randomly divided into three groups to adapt to the surrounding environment three days before experiments, preoperative fasting48h and forbidden water8h, in order to avoid adverse events in anesthesia induction, such as nausea, vomiting and palpitation. All surgical procedures on mini pigs were carried out under sterile conditions. The preoperative preparation in accordance with the extraperitoneal colon colostomy establish chitterlings stoma model.
Give liquid diet1-3days after surgery, and gradually transition to normal diet with closely observe animal life signs change. After general condition is stabilized, place the artificial anus plugging device with the same diameter each group, the device was placed about6-8h every day. Measured the intestinal pressure and set the pressure of opening the device each group were5mmHg,10mmHg,15mmHg. Decide whether to open the device according to the intestinal pressure measured, to achieve fecal continence.
5. Perception sensitivity and stoma leakage of each group:Animals in each group set different intestinal pressure upper limit, respectively, the device were placed at postoperative1,4,8weeks, and opened when intestinal pressure reach the set value. We observed whether there have intestinal contents and repeated20times each individual, to calculate the sensitivity. Placed the device at postoperative1,4,8weeks, and observed the number of leakage within6h after the intestinal pressure reach the set value, to evaluate the occlusion effect of the plugging device.
Date were expressed as mean value and standard deviation (x±s). Categorical data were calculated by nonparametric test for several independent samples (Kruskal-Wallis test) and several related sample (Friedman test). All analysis of variance were analyzed with SPSS13.0software (SPSS Incorporated, Chicago, IL, USA). A value of P<0.05was considered significant.
Results:
1. Perception sensitivity comparable in intestinal contents of intelligent artificial anus plugging device within different intestinal pressure:In general, the perception sensitivity with intestinal pressure has a rising trend, and when the intestinal pressure reached15mmHg, the perceived sensitivity of artificial anus plugging device combined with the pressure sensor were above90%in the postoperative period. There is no significant time effect differences in perception sensitivity among5mmHg group,10mmHg group and15mmHg group (P>0.05), postoperative1week,4weeks and8weeks, the significant difference of perceived sensitivity were observed among the groups(P<0.05). This may be due to gastrointestinal function is not fully recovered which lead to the less perception sensitivity in intestinal contents in the early postoperative period.
2. Stoma leakage comparable in intestinal contents of intelligent artificial anus plugging device within different intestinal pressure:Groups stoma leakage of colostomy are on a decreasing trend over time progress, which may be associated with the narrowing stoma diameter in postoperative period. There is a significant difference in15mmHg group among each time period leak (P=0.050), meanwhile, There is no significant time effect in5mmHg group and10mmHg groups of stoma leakage. At the same period, the stoma leak situation are positively correlated with intestinal pressure, postoperative one week among each group in stoma leakage situation difference was statistically significant (P=0.030<0.05), and4weeks and8weeks after surgery, there is no significant difference in stoma leakage situation among each group.(P=0.058>0.051>0.05)
Conclusions:
1. The artificial anus plugging device combined with pressure sensor for small pig anirnal studies, to observe the occlusion effect of plugging device by measuring the intestinal pressure.
2. Open the artificial anus plugging device when the intestinal pressure reach10mmHg-15mmHg, pressure sensor sensing high sensitivity, meanwhile, does not influence the occlusion effect.
3. The artificial anus plugging device introduced this research can be better fixed plug, and clean reusable, however, place the two-piece plugging device would easily cause intestinal stoma prolapse, and the diameter of plugging device to be based on change of intestinal stoma diameter change, which effect the blocking effect.
4. The mini-pig intestinal stoma model is proven to be effective.8weeks postoperatively, mini-pig intestines colostomy is normal in defecation, which can better situlate the normal process of defecation.
由于结直肠癌等疾病发病率的上升,肠造口术已成为外科最常施行的手术之一,替代了原位肛门,可缓解各种原因引起的排便失禁、排便困难等症状,故称人工肛门。全球每年由于结直肠癌、外伤、炎症及先天性畸形等而需行肠造口术者达数十万人之多,肠造口对患者本人的心理、生理及社会等多方面均产生较大的影响,其主要原因在于：(1)肠造口处排便难以控制,常有粪便漏出,且伴有异味；(2)肠造口处周围皮肤长期受粪便、肠液等刺激,容易并发各类皮炎。目前临床上对于肠造口患者术后护理中,肠造口袋的应用最为广泛,造口袋可防止粪便污染皮肤及异味传播,并对排便进行适当控制,从而改善生活质量。
大便失禁又称肛门失禁,是指持续或反复发作的不能感知肠内容物性质或肠内容物的排出控制障碍,包括固态、液态、气态的肠内容物,是复杂的、多因素导致的排便功能紊乱。国际上对大便失禁的定义为大于3岁的个体,连续或经常不受控制地通过粪便(>10mL),其主要表现为对粪便控制能力的下降,导致排便次数增多,常有腹泻。这些临床症状严重影响患者的日常生活,并给患者带来精神压力。
近年来人们开始研究各种人工肛门封堵装置,以求达到简化操作、控制排便、改善生活质量的目的。研究表明,人工肛门封堵器可有效的封堵肠造口、防止粪便漏出,但泄漏、缺血、感染作为人工肛门封堵器使用时常出现的并发症仍没有办法全部消除。目前已知的人工肛门封堵器均对排便无感知能力,也不能分辨肠内容物性质,只能依靠定时开放封堵装置来控制排便。与此同时,肠造口报警装置的出现,使肠造口封堵器的智能化存在可能。人们通过报警装置,可以感知肠蠕动,进而人为控制排便,但是由于报警装置体积偏大,且肠造口处封堵效果未知,不便于携带的同时,需警惕粪便泄漏产生造口周围感染。目前智能型人工肛门封堵器的相关研究较少,当肠内压力过高时,容易引起造口周围泄漏、感染及造口脱垂等并发症出现；而当肠内压力较低时,开放封堵器进行排便意义不大,且增加开放肠造口次数会给患者生活上带来不便。本实验将压力感应系统与人工肛门封堵器结合起来,通过观察不同肠内压力下同一直径人工肛门封堵器的封堵效果,评估智能型人工肛门封堵器的可行性,以探讨肠内压力与封堵器开放时机的关系,为临床进一步研究和人工肛门封堵器产品提供一定的指导作用。
方法：
1、本实验所用人工肛门封堵器模型由医用有机硅橡胶制成,有机硅橡胶作为传统的生物医学材料,具有良好的生物相容性、耐热、耐老化性能、容易加工成各种形状等优点。模型分为3部分,黏附于造口周围皮肤的基底座、固定于基底座上的封堵塞以及封堵塞头端的球囊组成,基底座胶圈及固定部分均取自Coloplast公司生产的二件式造口袋。封堵器实体部分为圆柱形,从模型内部穿过封堵器放置一橡胶管,连接球囊,将封堵器插入肠造口内,与基底座对合后固定于腹壁上,防止粪便漏出。往橡胶管内注入一定量的水,使得球囊扩张,初始压力调零,当产生肠内容物时,撞击球囊,通过PCLAB-UE生物信号采集处理系统(北京微信思达公司生产,由南方医科大学机能实验室提供)测定肠腔内变化的压力。
2、计算机生物信号采集处理系统是以计算机为核心,结合可扩展的软件技术,集成生物放大器与电刺激器,并且具备图形显示、数据存储、数据处理与分析等功能的电生理学实验设备。其工作基本原理是：首先将原始的生物机能信号,包括生物电信号和通过传感器引入的生物非电信号进行放大、滤波等处理,然后对处理的信号进行模/数(A/D)转换进行数字化,并将数字化后的生物机能信号传输到计算机内部,计算机硬件主要完成对各种生物电信号以及非生物电信号的采集,并对采集到的信号进行调整、放大,进而对信号进行转换,使之进入计算机。软件主要用来对已经数字化了的生物信号进行显示、记录、存储、处理及打印、输出,同时对系统各部分进行控制,使之能与操作者进行对话。
3、压力传感器可以将各种压力变化(如动脉压、经脉压、心室内压、肠内压力等)转换为电信号,然后将这些电信号经过放大输入到记录装置,以便对其所代表的生理变化深入分析,测量范围在-70mmHg-300mmHg。具有精度高、稳定性好；灵敏度高,输出信号大；工作温度范围宽、安全、隔离、防漏等优点。4、随机将实验动物分成三组,动物实验前适应周围环境3天,术前禁食48h,禁水8h,禁食第1天可给予少量葡萄糖液体,第2天严格禁食,完成术前准备后按照腹膜外结肠造口术建立猪肠造口模型。术后第1-3天给予流质饮食,逐步过渡到正常饮食,期间密切观察动物生命体征变化情况,待全身状况稳定后放置封堵器,各组放置封堵器直径一致,每天放置约6-8h,术后测定肠内压力,设定每组开放封堵器的压力分别为5mmHg、10mmHg、15mmHg。根据肠内压力值决定封堵器开放时机,控制排便。
5、感知灵敏度及泄漏率测定：术后第1、4、8周放置封堵器,待达到设定值后打开封堵器,观察是否有肠内容物存在,排空肠内容物后再次置入封堵器,重复观察20次,计算其灵敏度；放置封堵器后,实时监测肠内压力变化,待肠内压力达到预设值时,观察一定时间(约6h)内造口发生泄漏的次数。
应用SPSS13.0统计学软件上进行数据处理,所有数据均以x±s表示,采用多个独立样本非参数检验(Kruskal-Wallis test)比较每个时间点三组间有无显著差异,及多个相关样本的非参数检验(Friedman test),主要是用来检验每组的有无时间效应,上述结果以P<0.05认为差异有统计学意义。
结果：
1、不同肠内压力下智能型人工肛门封堵器感知肠内容物敏感度比较：总体而言,感知灵敏度随肠内压力升高有上升趋势,而当肠内压力达到10mmHg～15mmHg时,术后第4周后人工肛门封堵器结合压力传感器的感知灵敏度在术后各时间段均达到85%以上。各组感知灵敏度的差异并无明显的时间效应(P=0.178、0.670、0.761>0.05),术后第1周、第4周及第8周,各组感知灵敏度有显著性差异(P=0.026、0.034、0.045<0.05),可认为不同肠内压力对感知灵敏度有显著差异,根据平均秩次进一步推断,以15mmHg组感知灵敏度最高,10mmHg组次之,5mmHg组的感知灵敏度相对最低。这可能是由于术后早期,胃肠功能未完全恢复,肠内容物感知敏感程度较低所致。
2、不同肠内压力下智能型人工肛门封堵器泄漏次数比较：各组造口泄漏情况均随着时间进展有减少的趋势,这可能与术后造口直径缩小有一定关系。15mmHg组中各时间段泄漏次数有显著性差异(P=0.050),而5mmHg组及10mmHg组中泄漏次数并无明显时间效应(P=0.080>0.05)。在同一时段,造口泄漏情况与肠内压力成正相关关系,术后第1周,各组在造口泄漏情况差异有统计学意义(P=0.030<0.05),而在术后第4周及第8周,各组在造口泄漏情况无显著性差异。可认为不同肠内压力对造口泄漏率有显著差异,根据平均秩次进一步推断,以15mmHg组造口泄漏次数最多,10mmHg组次之,5mmHg组的造口泄漏次数相对最少。而在术后第4周及第8周,各组在造口泄漏情况无显著性差异(P=0.058、0.051>0.05)。
结论：
1、首次将人工肛门封堵器与压力传感器有机的结合起来,用于小型猪进行动物实验研究,通过测量肠内压力的变化来观察封堵器的封堵效果。
2、肠内压力在10mmHg-15mmHg时,压力传感器感知灵敏度高,此时开放封堵器可较好的进行排便,且不影响封堵效果。
3、该人工肛门封堵器与其他类型封堵装置相比,可更好的固定栓子、且清洗干净后可重复使用；但放置该封堵器易引起肠造口脱垂,且封堵器直径需根据肠造口直径的变化而变化,影响封堵效果。
4、小型猪肠造口模型构建方法有效,术后第8周,小型猪肠造口处排便正常,可更好的模拟人正常排便过程。
Background and objection:
Colostomy is one of the most common surgical procedures available for patients with colorectal cancer (CRC), because of whose incidence rates substantially increases. Colostomy also called artificial anus, which can alternative situ anus, relieve the symptoms of various causes of fecal incontinence and constipation. There are over hundreds of thousands of patients with a sigmoid colostomy because of colorectal cancer, trauma, inflammation and congenital deformity, and stoma-related complications occur frequently creating specific care problem in psychological, physiological, society and may even cause social restrictions and have a major impact on the outcome in term of patients' coping with their new life style, patients with colostomy may suffer incontinence and lack of control over gas and feces that the normal rectal sphincter affords, which complicated by the various types of dermatitis. Colostomy bag is the most widely used for postoperative care of patients with colostomy, which prevent the fecal contaminating peristoma skin and spreading odor, appropriately control defecation, to improve the quality of life (QoL).
Fecal incontinence which is defined as continuous or recurrent uncontrolled passage of fecal material (>10mL) for at least one month in an individual older than three years of age, is the persistent or recurrent can not perceive the shape of the intestinal contents or unable to control the discharge of intestinal contents, including liquid, gaseous, solid intestinal contents, is a complex, multifactorial defecationdysfunction, damage to the ability to control gas or stool, resulting in an increase in the number of bowel movements, often diarrhea. These clinical symptoms seriously affect the patient's daily life, and bring patients to mental stress.
In recent years, people started to study a variety of artificial anus closure device, in order to simplify the operation, control defecation, and improve the quality of life. Reports have shown that artificial anus plugging device can achieve colostomy continence, however, the colostomy fecal leakage, odor, skin infection and other complications cannot eliminate completely. The current known artificial anus plugging device cannot distinguish the nature of the intestinal contents, patients do not know when to evacuate, and they have to establish a bowel habit to defecate after opening the device at regular intervals. Meanwhile, colostomy alarm device provides an apparatus and method for monitoring the presence of fecal mass in a stoma, to control defecation artificially. The volume of alarm device is too large to carry, and the occlusion effect is unknown with high incidence of fecal leakage and peristoma infection, however, the colostomy alarm device provides the possibility of intelligent artificial anus plugging device, which relevant research are not taken seriously. Here we describe an intelligent artificial anus plugging device, which consists of an artificial anus plugging device and pressure sensor, observe the occlusion effect comparison with different intestinal pressure and evaluate the feasibility of intelligent artificial anus plugging device, so as to explore the appropriate timing of the device open for further clinical studies and application provide the basis for intelligent artificial anus plugging device.
Methods and materials:
1. The device is made of silicone rubber, which is a traditional biomedical material with some advantages, such as good biocompatibility, heat and aging resistance, easily processed into a variety of shapes. The plugging device model consisting of an adhesive base plate surrounding the stoma skin, a disposable cylinder colostomy plug and an inflatable balloon located in the head end of the plug. The plug can be applied on colostomies up to4.0cm in diameter. The base plate apron and fixed part are taken from the two-piece colostomy bag produced by Coloplast.
Application of the device is fairly simple. Once the plug is inserted into the colostomy, connected it with base plate fixed in the abdominal wall, inflate the balloon cuff with10mL of water using a20mL plastic syringe, and regulate the initial intestinal pressure. The volume of water to be introduced ranges from10-15mL according to the size of the colon. When stool enters into the colon and strike the inflated balloon, changing intestinal pressure was measured through pressure sensor in vitro.
2. Computer bio-signal collection and processing system based on the computer as the core, combined with the extensible software technology, integrated of biological amplifier with electrical stimulator, and had a graphical display, data storage, data processing and analysis functions electrophysiology laboratory equipment. Hardware mainly to complete a variety of biological electrical signals, such as electrocardiogram (ECG), electromyography (EMG), electroencephalogram (EEG) and non-bio-electrical signals (such as blood pressure, tension, breathing) collection, adjust and amplificate the collected signal, then turn on signal analog/digital (A/D) conversion, and make it into the computer. Software mainly used for displaying, recording, storing, processing, and printing output the biological signal digitized, to controlling the various parts of the system at the same time, to make a dialogue with the operator.
3. The pressure sensor may converted a variety of pressure change (such as arterial pressure, meridians pressure, ventricular pressure, intestinal pressure, etc.) to an electrical signal, and then the electrical signal after amplification inputted to the recording apparatus, so as to analysis the physiological changes that is in a position to represent in-depth. Pressure sensor has some advantages, such as high accuracy, good stability, high sensitivity, output signal; wide operating temperature range, security, isolation, and proof.
4. All animals randomly divided into three groups to adapt to the surrounding environment three days before experiments, preoperative fasting48h and forbidden water8h, in order to avoid adverse events in anesthesia induction, such as nausea, vomiting and palpitation. All surgical procedures on mini pigs were carried out under sterile conditions. The preoperative preparation in accordance with the extraperitoneal colon colostomy establish chitterlings stoma model.
Give liquid diet1-3days after surgery, and gradually transition to normal diet with closely observe animal life signs change. After general condition is stabilized, place the artificial anus plugging device with the same diameter each group, the device was placed about6-8h every day. Measured the intestinal pressure and set the pressure of opening the device each group were5mmHg,10mmHg,15mmHg. Decide whether to open the device according to the intestinal pressure measured, to achieve fecal continence.
5. Perception sensitivity and stoma leakage of each group:Animals in each group set different intestinal pressure upper limit, respectively, the device were placed at postoperative1,4,8weeks, and opened when intestinal pressure reach the set value. We observed whether there have intestinal contents and repeated20times each individual, to calculate the sensitivity. Placed the device at postoperative1,4,8weeks, and observed the number of leakage within6h after the intestinal pressure reach the set value, to evaluate the occlusion effect of the plugging device.
Date were expressed as mean value and standard deviation (x±s). Categorical data were calculated by nonparametric test for several independent samples (Kruskal-Wallis test) and several related sample (Friedman test). All analysis of variance were analyzed with SPSS13.0software (SPSS Incorporated, Chicago, IL, USA). A value of P<0.05was considered significant.
Results:
1. Perception sensitivity comparable in intestinal contents of intelligent artificial anus plugging device within different intestinal pressure:In general, the perception sensitivity with intestinal pressure has a rising trend, and when the intestinal pressure reached15mmHg, the perceived sensitivity of artificial anus plugging device combined with the pressure sensor were above90%in the postoperative period. There is no significant time effect differences in perception sensitivity among5mmHg group,10mmHg group and15mmHg group (P>0.05), postoperative1week,4weeks and8weeks, the significant difference of perceived sensitivity were observed among the groups(P<0.05). This may be due to gastrointestinal function is not fully recovered which lead to the less perception sensitivity in intestinal contents in the early postoperative period.
2. Stoma leakage comparable in intestinal contents of intelligent artificial anus plugging device within different intestinal pressure:Groups stoma leakage of colostomy are on a decreasing trend over time progress, which may be associated with the narrowing stoma diameter in postoperative period. There is a significant difference in15mmHg group among each time period leak (P=0.050), meanwhile, There is no significant time effect in5mmHg group and10mmHg groups of stoma leakage. At the same period, the stoma leak situation are positively correlated with intestinal pressure, postoperative one week among each group in stoma leakage situation difference was statistically significant (P=0.030<0.05), and4weeks and8weeks after surgery, there is no significant difference in stoma leakage situation among each group.(P=0.058>0.051>0.05)
Conclusions:
1. The artificial anus plugging device combined with pressure sensor for small pig anirnal studies, to observe the occlusion effect of plugging device by measuring the intestinal pressure.
2. Open the artificial anus plugging device when the intestinal pressure reach10mmHg-15mmHg, pressure sensor sensing high sensitivity, meanwhile, does not influence the occlusion effect.
3. The artificial anus plugging device introduced this research can be better fixed plug, and clean reusable, however, place the two-piece plugging device would easily cause intestinal stoma prolapse, and the diameter of plugging device to be based on change of intestinal stoma diameter change, which effect the blocking effect.
4. The mini-pig intestinal stoma model is proven to be effective.8weeks postoperatively, mini-pig intestines colostomy is normal in defecation, which can better situlate the normal process of defecation.
引文
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