Department of Biomedical Engineering, Lerner Research Institute, 2569Cleveland Clinic, OH, USA.
Transplant Center, Department of General Surgery, 2569Cleveland Clinic, OH, USA.
Surg Innov. 2020 Oct;27(5):507-514. doi: 10.1177/1553350620927579. Epub 2020 Jun 3.
. The aim of this study was to evaluate a motion-activated system (MAS) that applies motion-activated energy (vibration) to prevent chest tube clogging and maintain tube patency. We performed chest tube blood flow analysis in vitro, studied MAS effects on intraluminal clot deposition in vivo, and conducted a pilot clinical test. . Chest tube clogging is known to adversely contribute to postoperative cardiac surgery outcomes. . The MAS was tested in vitro with a blood-filled chest tube model for device acceleration and performance. In vivo acute hemothorax studies (n = 5) were performed in healthy pigs (48.0 ± 2 kg) to evaluate the drainage in MAS versus control (no device) groups. Using a high-speed camera (FASTCAM Mini AX200, 100 mm Zeiss lens) in an additional animal study (n = 1), intraluminal whole-blood activation imaging of the chest tube (32 Fr) was made. The pilot clinical study (n = 12) consisted of up to a 30 minutes device tolerance test. . In vitro MAS testing suggested optimal device performance. The 2-hour in vivo evaluation showed a longer incremental drainage in the MAS group versus control. The total drainage in the MAS group was significantly higher than that in the control group (379 ± 144 mL vs 143 ± 40 mL; = .0097), indicating tube patency. The high-speed camera images showed a characteristic intraluminal blood "swirling" pattern. Clinical data showed no discomfort with the MAS use (pleural = 4; mediastinal = 8). . The MAS showed optimal performance at bench and better drainage profile in vivo. The clinical trial showed patients' tolerance to the MAS and device safety.
. 本研究旨在评估一种运动激活系统 (MAS)，该系统通过应用运动激活能量（振动）来防止胸管堵塞并保持管腔通畅。我们进行了体外胸腔引流管血流分析，研究了 MAS 对管腔内血栓形成的体内影响，并进行了一项试点临床研究。. 众所周知，胸腔引流管堵塞会对心脏手术后的结果产生不利影响。. 我们使用充满血液的胸腔引流管模型对 MAS 设备进行了体外加速和性能测试。在健康猪（48.0 ± 2 kg）中进行了急性血胸的体内急性研究（n = 5），以评估 MAS 与对照组（无设备）的引流效果。在另一项动物研究（n = 1）中，使用高速摄像机（FASTCAM Mini AX200，100 mm Zeiss 镜头）对胸腔引流管（32 Fr）的管腔内全血激活成像进行了评估。在试点临床研究（n = 12）中，进行了长达 30 分钟的设备耐受性测试。. 体外 MAS 测试表明设备性能最佳。2 小时的体内评估显示 MAS 组的增量引流时间长于对照组。MAS 组的总引流量明显高于对照组（379 ± 144 mL 比 143 ± 40 mL； =.0097），表明管腔通畅。高速摄像机图像显示出特征性的管腔内血液“旋转”模式。临床数据显示，患者对 MAS 的使用无不适（胸膜 = 4；纵隔 = 8）。. MAS 在体外表现出最佳性能，体内引流效果更好。临床试验表明患者对 MAS 和设备的耐受性以及设备安全性。
