Artificial Anal Sphincter using Shape Memory Alloys

使用形状记忆合金的人工肛门括约肌

• 批准号: 13470375
• 负责人: TAKAGI Toshiyuki
• 金额: $ 9.22万
• 依托单位: Tohoku University
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (B)
• 财政年份: 2001
• 资助国家: 日本
• 起止时间: 2001 至 2003
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-13470375/
• 关键词: Artificial organs; Sphincters; Shape memory alloys; Fecal incontinence; 人工肛門; 便失禁; 鎖肛; ブタ

Following results and achievements have been attained in this project.1)In the first fiscal year of the project, we established the protocol of animal experiments for colostomy with piglets, implanted prototypes of the artificial sphincters under the stomas, and were successful in short-term animal experiments in the respects of basic functions : the closing and opening functions of the device.2)The second year of the project was devoted to the development of a transcutaneous energy transmission system and overheating prevention equipment in order to realize a complete implantation of the device. Animal experiments with periods of up to 4 weeks were carried out using these equipments. The healthy situation of the animal (piglet) in these experiments was confirmed. Moreover, ordinary evacuation was observed almost each time when the artificial sphincter was activated in open.3)The optimum design about the dimension and shape of the artificial sphincter was conducted. With the improved prototypes implanted into animals, the monitoring of the inner pressure was carried out with a pressure sensor inserted in the closed intestine. It was found that with the occlusion pressure ranging from 50 to 60mmHg, the device had sufficient closing function without any damage of ischemia.4)As a result of the careful design of the overheating protection and thermal insulation in materials and dimension, even when artificial sphincter was heated to open for a period longer than 10 min., it was able to control the temperature of its surface in contact with surrounding tissues to be lower than the maximum allowed temperature of living tissue,40℃.The occlusion pressure and surface temperature of the device are two most important criterions in the assessment of the device. The success in solving these two problems in this project will facilitate the commercialization of the device in near future.

本项目取得了以下成果和成就：1）在项目的第一个财政年度，我们制定了仔猪结肠造口动物实验方案，在造口下植入了人工括约肌原型，并在基本功能方面成功进行了短期动物实验：2）项目的第二年致力于开发经皮能量传输系统和防过热设备，以实现器械的完整植入。使用这些设备进行了长达4周的动物实验。证实了这些实验中动物（仔猪）的健康状况。此外，几乎每次打开人工括约肌时都能观察到正常的排空。3）对人工括约肌的尺寸和形状进行了优化设计。将改进的原型植入动物体内，用插入闭合肠中的压力传感器进行内部压力的监测。4）由于在材料和尺寸上精心设计了过热保护和隔热措施，即使人工括约肌加热打开时间超过10分钟，它能够控制其与周围组织接触的表面温度低于活组织的最高允许温度40℃。封堵压力和器械表面温度是评估器械的两个最重要标准。这两个问题的成功解决将有助于该装置在不久的将来实现商业化。

项目成果

神山 隆道: "形状記憶合金を用いた人工肛門括約筋"小児外科. Vol.33,No.12. 1377-1381 (2001)

Takamichi Kamiyama：“使用形状记忆合金的人工括约肌”小儿外科，第 33 卷，第 1377-1381 期（2001 年）。

西 功太郎: "形状記憶合金を用いた人工肛門括約筋の開発 第2報"日本小児外科学会雑誌. Vol.38,No.3. 424 (2002)

Kotaro Nishi：“使用形状记忆合金开发结肠造口括约肌第二次报告”日本小儿外科学会杂志第 38 卷，第 424 期（2002 年）。

Kataro Nishi: "Development of an Implantable Artificial Anal Sphincter Using a Shape Memory Alloy"Journal of Pediatric Surgery. 39・1. 69-72 (2004)

Kataro Nishi：“使用形状记忆合金开发植入式人工肛门括约肌”小儿外科杂志 39・1（2004 年）。

Tomoyuki Yambe: "Recent Progress in Artificial Organ Research at Tohoku University"Artificial Organs. 27・1. 2-7 (2003)

Tomoyuki Yambe：“东北大学人工器官研究的最新进展”人工器官27・1（2003）。

西 功太郎, 他: "形状記憶合金を用いた人工肛門括約筋の開発 第2報"日本小児外科学会雑誌. 38巻3号. 424 (2002)

Kotaro Nishi 等人：“使用形状记忆合金开发结肠造口括约肌，第 2 次报告”，日本小儿外科学会杂志，第 38 卷，第 3. 424 期（2002 年）。