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基于无线通信和无线供能的新型人工括约肌的研制
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摘要
肛门失禁又称大便失禁,是由于某些器质性病变或支配肛门括约肌的神经作用失常,造成肛门括约肌不受意识控制而不能自主排便。虽然肛门失禁并不直接威胁生命,但对患者造成身体和精神上的双重痛苦,同时也给患者的家庭及社会带来很大负担。对于肛门直肠周围神经肌性损伤者、顽固性肛门失禁患者,目前国内外所采用的治疗方法往往达不到满意的治疗效果。这也是目前肛肠外科临床工作者面临的共同问题。
     为了从根本上解决因直肠癌及其他原因导致肛门失禁患者的排便控制问题,针对现有造口手术或人工肛门括约肌存在的不足和缺陷,我们提出研制一种“基于无线通信和无线供能的新型人工括约肌”,模拟正常的人体肛门括约肌的工作机理,提高人造肛门的人性化程度,消除现有造口手术给患者带来的生理、心理等方面的严重影响。本研究利用人工膀胱颈部括约肌的设计构思及正常内括约肌反射生理原理,采用泵式钳夹作用、信号反馈、患者自主开放等方法,帮助患者控制排便。
     整个人工肛门括约肌控制系统集成以下模块:信息传感模块、无线通信模块、无线供能模块、报警提示模块、便捷控制模块和执行机构。信息传感模块对患者的肠道压力进行采样,系统在对采样值进行处理后,通过无线通信模块传送到体外。在安置有泵式括约肌部位肠管以上的肠道压力超过了预先设定的阈值时,启动报警电路,提示患者进行排便。患者可以通过便捷控制按钮手动控制执行机构,开放人工泵式括约肌,进行排便。而无线供能模块包括体外能量发射模块和体内能量接收模块两部分,无线供能需满足体内无线通信模块、信息传感模块和执行机构的供电需求,供电平稳。
     在模拟实验中,该人工括约肌装置能够有效地控制模拟大肠末端开/放,基本达到了预期的效果。当然,基于无线通信和无线供能的新型人工括约肌是生物医学工程与临床医学紧密结合的产物,为了将来能真正应用到临床中,今后还需要进一步进行动物实验和临床分析。我们坚信,该项技术必将是治疗排便功能障碍的一种有效的新途径,尤其是对于顽固性无残剩神经肌肉条件的肛门失禁患者,不啻是一种福音。
     本文详细介绍了该系统的总体设计方案、各模块设计及系统实现,并给出了实验样机和实验结果。最后,在论文的结尾对整个系统进行了分析总结,并展望了下一步的研究方向,以解决目前系统以及将来临床应用中可能遇到的问题。
Fecal incontinence is a common disease in intestines and anus surgery, featured by defecation disability and caused by pathological changes. Fecal incontinence does not only bring both body and mental sufferings to patients, but also causes a lot of social burden. There are still no efficient treatment methods for the patients with fecal incontinence, and it is also a difficult problem for doctors and researchers of anus surgery.
     In order to help those patients with defection control problem thoroughly, enlightened by the artificial urethra sphincter, we decided to develop a new anal sphincter based on wireless communication and wireless power supply to simulate the operation mechanism of normal anus sphincter and eliminate the serious physiological and mental infection caused by existing anus surgery. The system integrates the following modules: information sensor module, wireless communication module, notice module, control module, execution unit and wireless power supply module. The sensor module measures the pressure of large intestine, and then the system transmits the processed data out of body via wireless communication module. The notice module starts and reminds patients to defecate as soon as the pressure exceeds the threshold. Patients can press control buttons to open the sphincter and defecate. The wireless power supply module includes two parts, the external power transmission part and the internal power receive part. The wireless power supply module fulfills the power requirement of internal wireless communication module, information sensor module and execution unit.
     During simulated animal experimentation, the whole system could realize the function of human anal sphincter and reach our expectation. The new anal sphincter, based on wireless communication and wireless power supply, is the combination for biomedicine and clinic medicine. Therefore, this artificial anus system needs more animal experiment and clinic analysis in the near future. We believe that the new anal sphincter is a brand-new way to treat fecal incontinence, and it is especially an evangel for patients suffered from fecal incontinence of neuromuscular origin.
     This thesis introduces the design of the new anal sphincter system, including the whole structure, modules design and system realization. It also gives out prototype machine and experimental result. The assumption of improvement and direction of further research is also carried out at the end of this thesis.
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