Development of percutaneously adjustable pulmonary artery banding device

经皮可调肺动脉束扎装置的研制

• 批准号: 14571273
• 负责人: YAMAGISHI Masaaki
• 金额: $ 1.66万
• 依托单位: Kyoto Prefectural University of Medicine
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 2002
• 资助国家: 日本
• 起止时间: 2002 至 2004
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-14571273/
• 关键词: Adjustable pulmonary artery banding; 肺動脈絞扼デバイス

Background : In patients with congenital heart defect and increased pulmonary blood flow, pulmonary artery banding has widely achieved as a palliative operation. However, to obtain optimal pulmonary blood flow is difficult by conventional procedure in some cases. Consequently, multiple operations are often necessary to readjust the pulmonary artery banding. The percutaneously adjustable banding device would be thought very useful.Material : The device consists of a noncompliant balloon with outer band that can be snared around the pulmonary artery. One extremity of the balloon is connected by a catheter to a reservoir. When the balloon is inflated by injection of distilled water through the reservoir, internal diameter of the band is decreased, because the band is not compliant. Method : Six dogs (10-15kg) underwent pulmonary artery banding using a new device, by median sternotomy. The possibility of percutaneously adjusting the band was evaluated immediately after implantation of pulmonary artery banding device. The degree of pulmonary constriction was adjusted by injecting or removing distilled water from balloon through the reservoir under constant monitoring of the right ventricular and pulmonary arterial pressures distal to the band. Also, pulmonary arterial diameter was measured by Intravascular Ultrasound.Results : Pressure gradient between right ventricular and pulmonary arterial pressure distal to the band showed 14.3±12.3mmHg (injected volume 0.5ml), 18.8±11.9mmHg (1.0ml), 25.9±20.2mmHg (1.5ml). The value was not significant between each group.Conclusions : This device may be useful alternative to pulmonary artery banding. Further evaluation is necessary and potential clinical applications must be defined.

背景：在先天性心脏缺陷和肺血流量增加的患者中，肺动脉绑扎术已被广泛应用于姑息性手术。然而，在某些情况下，常规手术很难获得最佳的肺血流量。因此，经常需要多次手术来调整肺动脉带。这种经皮可调的绑带装置被认为是非常有用的。材料：该装置由一个带有外带的非顺应性球囊组成，可以绕在肺动脉周围。气球的一端通过导管与贮液器相连。当气球通过储罐注入蒸馏水充气时，由于带不弯曲，带的内径减小。方法：6只（10 ~ 15kg）犬采用新型装置经胸骨正中切开术行肺动脉捆扎术。肺动脉束带植入术后立即评估经皮调整束带的可能性。在持续监测右心室和远端肺动脉压的情况下，通过储液器从球囊中注入或取出蒸馏水来调节肺收缩的程度。同时，通过血管内超声测量肺动脉直径。结果：右心室与肺动脉远端压力梯度分别为14.3±12.3mmHg（注射量0.5ml）、18.8±11.9mmHg （1.0ml）、25.9±20.2mmHg （1.5ml）。各组间差异无统计学意义。结论：该装置可作为肺动脉捆扎术的有效替代。进一步的评估是必要的，并且必须确定潜在的临床应用。