具有恒力特性的人工肛门括约肌生物力学机理及设计方法研究

Incontinence is an unresolved problem which gives over 10 million patients a psychological, physiological impact. For patients with severe symptoms or failed in surgical treatments, an artificial sphincter is the only way to help them to maintain the continence. A well recognized difficulty in this technology is to maintain the long term biomechanical compliance, which is affected by the changes in both the morphology and mechanical properties in surrounding tissues of implants..In this project, the long term biomechanical matching mechanism between artificial sphincters and intestinal tissues will be studied. A new approach for enhancing the long term biomechanical compliance of implantable artificial sphincters will be proposed based on the usage of superelastic shape memory alloy and structural optimization design, to solve the key technical problems of the artificial sphincter in clinical application. A new design of artificial sphincters with miniaturization, simple structure, intelligent control and good long term mechanical compatibility will be given based on the new approach. At the same time, a personalized design method based on finite element analysis is established, to verify its effectiveness and safety by animal experiments..This project may establish a solid theoretical foundation for the study of artificial anal sphincter and promote its successful application in clinical practice.

便失禁是一个给千万患者造成心理及生理的巨大伤害，但至今仍未得到完全解决的医学难题。对重症患者及外科手术重建无效的情况，人工括约肌为其唯一节制手段。人工括约肌植入后肠管组织远期形态变化引起的生物力学相容性问题会导致括约肌功能失效、肠管组织缺血坏死或萎缩，是此项技术在临床应用中公认的瓶颈问题。. 本项目将研究人工括约肌与肠管组织的远期力学匹配机理，提出利用新型超弹性形状记忆合金与结构优化设计建立括约肌生物力学匹配节制的新方法，解决人工肛门括约肌面向临床的关键技术问题。研制小型化、结构简单化、控制智能化以及具有良好远期力学相容性的人工括约肌，同时建立基于有限元分析的个性化设计手段，并以动物实验验证其有效性与安全性。. 本项目可为人工肛门括约肌的研究奠定坚实的理论基础，推动其最终成功应用于临床。

便失禁是一个给千万患者造成心理及生理的巨大伤害，但至今仍未得到完全解决的医学难题。对重症患者及外科手术重建无效的情况，人工括约肌为其唯一节制手段。人工括约肌植入后肠管组织远期形态变化引起的生物力学相容性问题会导致括约肌功能失效、肠管组织缺血坏死或萎缩，是此项技术在临床应用中公认的瓶颈问题。.本项目初步研究了肠管组织的力学特性，探究了形状记忆合金板材或杆材结构构型及其力学特性，揭示结构参数对其恒力特性的影响机理，提出新的恒力结构实现方案。建立基于遗传算法与有限元方法的优化设计手段，并据此提出利用形状记忆合金超弹性设计恒力元件的综合方法，并通过实验验证其可行性与精确性。研制了具有恒力特性的人工肛门括约肌，试验验证了其恒力特性与安全性。研究成果在本领域重要学术期刊发表SCI论文8篇，申请发明专利8项。本项目可为人工肛门括约肌的研究奠定坚实的理论基础和技术储备。