北京生物医学工程

仿生人工肛门括约肌系统生物相容性及便意感知实验研究

Experimental study on biocompatibility and thefecal intention of a bionic artificial anal sphincter system

作者：丁紫凡颜国正姜萍萍姚盛健华芳芳周泽润

单位：上海交通大学电子信息与电气工程学院（上海 200240）  <p>通讯作者：颜国正，教授。E-mail:gzhyan@sjtu.edu.cn</p>

分类号：R318.04；TH 772 <p> </p>

出版年·卷·期（页码）：2021·40·5（461-470）

摘要：

目的针对人工肛门括约肌（artificial anal sphincter，AAS）长期植入活体后出现的生物相容性不佳、缺乏便意感知能力和血供安全性问题，提出一种仿生人工肛门括约肌系统（bionic artificial anal sphincter，BAAS）并进行实验评估。方法首先建立仿生人工肛门括约肌系统，系统采用封闭连杆式“三环”机构作为括约肌假体，外覆一体化医用硅橡胶薄膜以增强生物相容性，环臂嵌入10路压力传感模块，并采用经皮无线能量传输和无线通信实现体内外系统能量供给与信息交互。然后进行体外实验，以评估括约肌假体的控便能力与血供安全性，并创新地利用压力向量相似度作为便意判断的新标准建立便意智能感知模型。最后进行动物实验，对BAAS系统整体植入效果、生物相容性、控便及便意感知能力等进行观察和评估。结果体外实验表明，括约肌假体对肠道内容物的蓄控效果满足便意阈值需求，且最大夹持压力在肠道血供安全性范围内，满足控便和血供安全性要求。动物实验表明括约肌假体具有良好的密封性和生物相容性，验证了便意智能感知模型的可靠性，体内便意预警准确率最高可达80%。结论BAAS系统可以模拟肛门括约肌的功能，作为治疗重度肛门失禁的方法。

Objective Aiming at the problems of poor biocompatibility, lack of rectal perception as well as blood supply safety after long-term implantation of the artificial anal sphincter (AAS) into a living body, a bionic artificial anal sphincter system（BAAS）is proposed and evaluated by experiments. Methods First, we establish a BAAS system. The system uses a closed link type "three rings" mechanism as a sphincter prosthesis, which is covered with an integrated medical silicone rubber film and embedded with ten pressure sensor modules, and uses percutaneous wireless energy transmission and wireless communication to achieve energy supply and information interaction between the internal and external systems. Then vitro experiments are conducted to evaluate the feces control ability and the blood supply safety of the sphincter prosthesis, and we innovatively use the pressure vector similarity as a new criterion for determining stool intention to establish a stool intention intelligent perception model. Finally, animal experiments are carried out to observe and evaluate the overall implantation effect, biocompatibility, feces control and the feces perception ability of the BAAS system. Results The in-vitro experiment shows that the control effect of the sphincter prosthesis on the intestinal contents meets the requirements of the bowel intention threshold, and the maximum clamping pressure is within the safety range of the intestinal blood supply, meeting the requirements for bowel control and blood supply safety. Animal experiments have proved that the sphincter prosthesis has good leakproofness and biocompatibility, and at the same time, it has verified the reliability of the rectal perception model as the accuracy of the warning of the defecation is up to 80%. Conclusions The new BAAS system can simulate the function of the anal sphincter and can be used as a method of treating severe anal incontinence.

参考文献：

[1] Menees SB, ALMARIO C V, SPIEGEL B M R, et al. Prevalence of and factors associated with fecal incontinence: results from a population-based survey[J]. Gastroenterology, 2018, 154(6): 1672-1681.

[2] 董青军, 梁宏涛, 王琛, 等. 大便失禁的诊治策略[J]. 中国医药导报, 2018, 15(24): 26-29.

Dong QJ, Liang HT, Wang C, et al. Diagnosis and treatment strategy?of fecal incontinence[J]. China Medical Herald, 2018, 15(24): 26-29.

[3] Angela J, Khera, Janet W, et al. Gut-directed pelvic floor behavioral treatment for fecal incontinence and constipation in patients with inflammatory bowel disease.[J]. Inflammatory Bowel Diseases, 2018. 25(3)：.620-626

[4]?李建萍, 徐洪莲, 叶文琴. 肠造口并发症护理干预研究进展[J]. 解放军护理杂志, 2015, 32(18):33-35.

[5] Grossi U, De Simone V, Parello A, et al. Gatekeeper improves voluntary contractility in patients with fecal incontinence[J]. Surgical Innovation, 2019, 26(3): 321-327.

[6] Christiansen J, Lorentzen M. Implantation of artificial sphincter for anal incontinence[J]. Lancet (London, England),1987,?23(5): 244-245.?

[7] Zellmer T, Macdonald W. Palpable abdominal mass and recurrent fecal incontinence due to failure of artificial bowel sphincter[J]. Radiology case reports, 2019, 14(1): 66-68.

[8] Wang X, Dasilva G, Maron D J, et al. Outcomes of Reimplantation of the Artificial Bowel Sphincter[J]. Diseases of the Colon & Rectum, 2016, 59(2): 122-126.

[9] Finlay I G, Richardson W, Hajivassiliou C A. Outcome after implantation of a novel prosthetic anal sphincter in humans[J]. The British Journal of Surgery, 2004, 91(11): 1485-1492.

[10] Fattorini E, Brusa T, Gingert C, et al. Artificial Muscle Devices: Innovations and Prospects for Fecal Incontinence Treatment[J]. Annals of Biomedical Engineering, 2016, 44(5): 1355-1369.

[11] Doll A, Heinrichs M, Goldschmidtboeing F, et al. A high performance bidirectional micropump for a novel artificial sphincter system[J]. Sensors & Actuators A Physical, 2005, 130(none):445-453.

[12] Lehur P A , Mcnevin S , Buntzen S , et al. Magnetic anal sphincter augmentation for the treatment of fecal incontinence: a preliminary report from a feasibility study[J]. Diseases of the Colon & Rectum, 2010, 53(12):1604.

[13] Pakravan F, Helmes C. Magnetic Anal Sphincter Augmentation in Patients with Severe Fecal Incontinence [J]. Diseases of the Colon & Rectum, 2015, 58(1): 109-114.

[14] Litta F, Parello A, DE SIMONE V, et al. Efficacy of Sphinkeeper? implant in treating fecal incontinence [J]. The British journal of surgery, 2020, 107(5): 484-488.

[15] Wentian J, Guozheng Y, Hao W, et al. Preliminary Study of a Novel Puborectalis-Like Artificial Anal Sphincter[J]. Artificial Organs, 2017, 41(9): 845-851.

[16] Hao W, Zhiwu W, Guozheng Y, et al. A novel puborectalis muscle artificial anal sphincter system with the module of sensory perception[J]. Journal of Medical Engineering & Technology, 2017, 41(2): 97-107.

[17] Lei K, Guozheng Y, SHENG Y, et al. Optimal Design of Litz Wire Coils With Sandwich Structure Wirelessly Powering an Artificial Anal Sphincter System[J]. Artificial organs,2015,39(7): 615-626

[18] Minghui W, Ying Z, Shuang Z, et al. Challenges faced in the clinical application of artificial anal sphincters[J]. Journal of Zhejiang University-SCIENCE B, 2015, 16(9): 733-742.

[19] 刘芳, 胡琛. 生物医用抗菌性硅橡胶的研究进展[J]. 中国材料进展, 2016, 35(4):308-312.

Liu F, Hu C. Research development of the biological medical silicone?rubber with antimicrobial properties [J]. Materials China, 2016, 35(4): 308-312.

[20] Apeldorn T , Keilholz C , Wolff-Fabris F , et al. Dielectric properties of highly filled thermoplastics for printed circuit boards[J]. Journal of Applied Polymer ence, 2013, 128(6):3758-3770.

[21] Feerick E M , Kennedy J , Mullett H , et al. Investigation of metallic and carbon fibre PEEK fracture fixation devices for three-part proximal humeral fractures[J]. Medical Engineering & Physics, 2013, 35(6):712-722.

[22] Rasmussen OO, S?rensen M, Tetzschner T, et al. Anorectal pressure gradient in patients with anal incontinence[J]. Diseases of the colon and rectum, 1992, 35(1): 8-11.

[23] David P, Doris M H, Joel G, et al. Relationship among anal sphincter injury, patulous anal canal, and anal pressures in patients with anorectal disorders[J]. Clinical Gastroenterology and Hepatology, 2015, 13(10): 1793-1800

[24] Devesa JM, Rey A, Hervas PL, et al. Artificial anal sphincter: complications and functional results of a large personal series[J]. Diseases of the Colon & Rectum, 2002, 45(9):1154-1163.

[25] 克磊, 颜国正, 刘志强, 等. 人工肛门括约肌性能与生物相容性的动物实验[J]. 上海交通大学学报, 2014, 48(2): 193-198, 204.

Ke L, Yan GZ, Liu ZQ, et al. In vivo research of performance and biocompatibility of an artificial anal sphincter[J]. Journal of Shanghai Jiaotong University, 2014, 48(2): 193-198, 204.

[26] 李瑞, 王青山. 生物材料生物相容性的评价方法和发展趋势[J]. 中国组织工程研究与临床康复, 2011, 15(29): 5471-5474.

Li R, Wang QS. Evaluated methods and developmental trend of biocompatibility of biomaterials[J].?Journal of Clinical Rehabilitative Tissue Engineering Research, 2011, 15(29): 5471-5474.

[27] 冯媛媛, 白雪源, 贺津, 等. 中国实验用小型猪血液指标正常参考值分析[J]. 中国畜牧兽医, 2013, 40(6): 139-142.

Feng YY, Bai XY, He J, et al. Analysis of blood parameters in Chinese experimental mini-pigs[J]. China Animal Husbandry and Veterinary Medicine, 2013, 40(6): 139-142.

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