新一代反馈式人工肛门括约肌系统的研究
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摘要
近年,国内外开展了人工肛门括约肌系统的研制,为临床上根治大便失禁提供全新的方法和手段,但现有的系统在假体结构、便意重建和血供安全方面存在诸多缺点。为此,设计了反馈式人工肛门括约肌系统,其柱囊式括约肌假体采用生物材料制作,内置生物压力传感装置重建便意感知,实现排便报警,手持遥控端,控制双向滚轮式医用微泵定量地抽吸储液囊腔中的液体,从而实现假体对肠壁的咬合和释放。系统采用集成化封装,并经皮能量传输对体内系统供电。然后,从血供安全角度出发,借助猪大肠离体实验推导出阈值,并经活体动物实验,考察肠道血供安全、植入技巧和动物管理等信息。离体实验表明,系统能够有效地抑制肠道内容物渗漏,实现了对肠壁咬合压力的均匀分布(6.22～7.16 kPa),从血供安全的角度确定了排便阈值(12.9 kPa)并重建了反馈式排便感知;活体动物实验验证了可行性和有效性,运行稳定。
Recently,the research on artificial anal sphincter system is progressing both in China and abroad,which provides a new method in clinic treating fecal incontinence;however,the existing systems have various defects in prosthesis structure,reconstruction of defecation awareness and safety of blood supply.Therefore,a biofeedback artificial anal sphincter system is designed,in which biocompatible materials are used to make a pillar-bag-style anal sphincter prosthesis;a bio-pressure sensor is embedded to rebuild the awareness of defection and defection warning is achieved.With a handheld remote control,a bi-direction roller medical micro-pump is manipulated to pump liquid in or out of the fluid reservoir quantitively,the bowel surrounded by the prosthesis is occluded or released,and the restraining or freeing bowel contents are achieved.The system adopts integrated package,transcutaneous energy transmission is used to power the internal system.Then,the threshold value is deduced in vitro test of pig bowel from the perspective of blood supply safety.Finally,safety of bowel blood supply,implant skill and animal management are further investigated through animal experiment in vivo.The vitro experiment indicates that the system can hold the fecal,and the occlusion pressure between prosthesis and bowel is evenly distributed(around 6.22~7.16 kPa).Moreover,considering likely risk of ischemic injury to the bowel,the defecation threshold is selected as 12.94 kPa,and the defecation awareness is reconstructed.In vivo animal experiment verifies the feasibility and effectiveness of the proposed system;and the system operates stably.
Recently,the research on artificial anal sphincter system is progressing both in China and abroad,which provides a new method in clinic treating fecal incontinence;however,the existing systems have various defects in prosthesis structure,reconstruction of defecation awareness and safety of blood supply.Therefore,a biofeedback artificial anal sphincter system is designed,in which biocompatible materials are used to make a pillar-bag-style anal sphincter prosthesis;a bio-pressure sensor is embedded to rebuild the awareness of defection and defection warning is achieved.With a handheld remote control,a bi-direction roller medical micro-pump is manipulated to pump liquid in or out of the fluid reservoir quantitively,the bowel surrounded by the prosthesis is occluded or released,and the restraining or freeing bowel contents are achieved.The system adopts integrated package,transcutaneous energy transmission is used to power the internal system.Then,the threshold value is deduced in vitro test of pig bowel from the perspective of blood supply safety.Finally,safety of bowel blood supply,implant skill and animal management are further investigated through animal experiment in vivo.The vitro experiment indicates that the system can hold the fecal,and the occlusion pressure between prosthesis and bowel is evenly distributed(around 6.22~7.16 kPa).Moreover,considering likely risk of ischemic injury to the bowel,the defecation threshold is selected as 12.94 kPa,and the defecation awareness is reconstructed.In vivo animal experiment verifies the feasibility and effectiveness of the proposed system;and the system operates stably.
引文
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[2]CHITTAWATANARAT K,KOH D C,SEAH A A,et al.Arti-ficial bowel sphincter implantation for faecal incontinence inasian patients[J].Dis Colon Rectum,2010,33(3):134-141.
[3]SHAH B J,CHOKHAVATIA S,ROSE S,et al.Fecal in-continence in the elderly:FAQ[J].American Journal ofGastroenterology,2012,107(11):1635-1646.
[4]WU Y,WANG M H,LUO Y,et al.A novel artificialsphincter for functional assist to human puborectalis[J].International Journal of Applied Electromagnetics andMechanics,2012,39(8):457-462.
[5]LIU H J,LUO Y,HIGA M,et al.Biochemical evaluation ofartificial anal sphincter made from shape memory alloys[J].Artificial Organs,2010,10(8):223-227.
[6]DOLL A,HEINRICHS M,GOLDSCHMIDTBOEING F,etal.A high performance bidirectional micropump for a no-vel artificial sphincter system[J].Sensors and ActuatorsA-Physical,2008,130(12):445-453.
[7]RUTHMANN O,RICHTER S,SEIFERT G,et al.The firstteleautomatic low-voltage prosthesis with multiple thera-peutic applications:a new version of the German artificialsphincter system[J].Artif.Organs,2010,34(8):635-641.
[8]MARK T C,WONG,MEURETTE,et al.The magneticanalsphincter versus the artificial bowel sphincter:A com-parison of 2 treatments for fecal incontinence[J].Dis Co-lon Rectum.2011,54:773-779.
[9]HUANG Z H,SHI F J,CHEN F,et al.In vitro and in vivoassessment of an intelligent artificial anal sphincter inrabbits[J].Artificial Organs,2010,35(10):964-969.
[10]许茜茜,刘华,颜国正.植入式人工肛门括约肌系统的实现及动物实验[J].中国组织工程研究与临床康复,2012,16(13):2236-2341.XU Q Q,LIU H,YAN G ZH.Implementation and animal ex-periment of implantable artificial anal sphincter system[J].Journal of Clinical Rehabilitative Tissue Engineering Re-search,2012,16(13):2236-2341.
[11]GUO X D,YAN G ZH,JIANG P P,Feasibility of Localizingin vivo Micro-devices with Electromagnetic Methods[J].J.Shanghai Jiaotong Univ.(Sci.),2011,13(5):600-604.
[12]LIU H,YAN G ZH,et al.Artificial Anal Sphincter withSensor Feedback Powered by Transcutaneous EnergyTransmission[J].J.Shanghai Jiaotong Univ.(Sci.),2008,13(5):600-604.
[13]WONG W D,CONGLIOSI S M,SPENCER M P,et al.Thesafety and efficacy of the artificial bowel sphincter for fe-cal incontinence[J].Dis Colon Rectum,2003,45(9):1139-1153.
[14]HAJIVASSILIOU C A,FINLAY I G.Effect of a novel pros-thetic anal neosphincter on human colonic blood flow[J].BrJ.Surg,1998,85(6):1703-1707.
[15]Mai Songping.et.A New Cochlear Prosthetic System withan Implanted DSP[J].Journal of Semiconductors,2008,29(9):1746-1751.
[16]沈娜,李长生,张合.磁耦合共振无线能量传输系统建模与分析[J].仪器仪表学报,2012,33(12):2735-2741.SHEN N,LI CH SH,ZHENG H.Modeling and analysis ofwireless power transmission system based on magneticcoupling resonance[J].Chinese Journal of Scientific In-strument,2012,33(22):2735-2741.
[17]李长生,张合.基于非铁磁性金属管的无线能量与信息同步传输技术[J].仪器仪表学报,2011,33(5):1165-1170.LI CH SH,ZHANG H.Wireless power and informationsynchronous transmission technology based on non-ferro-magnetic metal tube[J].Chinese Journal of Scientific In-strument,2011,33(5):1165-1170.