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新型心脏插管辅助装置的研发与评估。

Development and assessment of novel assist device for cardiac cannulation.

机构信息

Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National Hospital, Washington, D.C., USA.

Division of Cardiovascular Surgery, Children's National Hospital, Washington, D.C., USA.

出版信息

Int J Comput Assist Radiol Surg. 2024 Jan;19(1):37-41. doi: 10.1007/s11548-023-03013-x. Epub 2023 Aug 23.

Abstract

PURPOSE

Congenital heart defects are the most common birth defects in the USA and in 25% of cases need to be treated with cardiovascular interventions. One of such interventions is the postoperative use of an extracorporeal membrane oxygenation (ECMO) machine for the treatment of cardiorespiratory failure. The process of placing the patient on the ECMO is extremely time-critical and requires the use of cardiac cannulation. For the first time, our team developed and evaluated a new quick-connect cannulation system that allows for rapid, easy, and safe ECMO cannulation in the pediatric population. The design should eliminate the need for purse-string sutures that are currently used to secure cannulas, as the cannulas will be inserted through a port that is glued to the cardiovascular tissue.

METHODS

The rapid cannulation assistance device was designed on the SolidWorks computer-aided design software using the dimensions of the commercially available arterial and venous catheters. These designs were then 3D printed, and tensile testing was performed. Then, a flow loop was developed, and cannulation was performed and analyzed on both 3D-printed hearts and porcine hearts.

RESULTS

The rapid cannulation assistance device was designed and 3D printed. Tensile testing found that the parts were strong enough to withstand forces that may be introduced in studies. 3D-printed and porcine heart tests with a flow loop found no leakage with the 3D-printed hearts but minimal leaking with the porcine hearts. However, this leakage was observed at the junction between the device and the heart, leading us to believe that a glue better suited to attach the device to the heart would prevent leakage in the future.

CONCLUSIONS

This project successfully demonstrated how a rapid cannulation assistance device could be developed and tested. Future studies will be conducted that address device adhesion to the cardiovascular tissue so that accurate pressure and flow rates can be measured. Future studies will also include testing the device in a fluid environment to more effectively analyze the device success and comparing the time required to cannulate using our device compared to the standard of care.

摘要

目的

先天性心脏病是美国最常见的出生缺陷,其中 25%需要进行心血管介入治疗。此类干预之一是术后使用体外膜肺氧合(ECMO)机治疗心肺功能衰竭。将患者置于 ECMO 上的过程极其关键,需要使用心脏插管。我们团队首次开发并评估了一种新的快速连接插管系统,该系统可在儿科人群中实现快速、简便、安全的 ECMO 插管。该设计应消除目前用于固定插管的荷包缝线的需要,因为插管将通过粘在心血管组织上的端口插入。

方法

快速插管辅助装置是在 SolidWorks 计算机辅助设计软件上设计的,使用了市售动脉和静脉导管的尺寸。然后对这些设计进行了 3D 打印,并进行了拉伸测试。然后,开发了一个流量回路,并在 3D 打印心脏和猪心上进行了插管和分析。

结果

快速插管辅助装置的设计和 3D 打印完成。拉伸测试发现,这些部件足够坚固,可以承受研究中可能引入的力。3D 打印和带有流量回路的猪心测试发现,3D 打印心脏没有泄漏,但猪心有轻微泄漏。然而,这种泄漏发生在装置和心脏的连接处,这使我们相信,一种更适合将装置附着在心脏上的胶水将防止未来的泄漏。

结论

本项目成功展示了如何开发和测试快速插管辅助装置。未来的研究将解决装置与心血管组织的附着力问题,以便能够准确测量压力和流量。未来的研究还将包括在流体环境中测试该装置,以更有效地分析装置的成功,并比较使用我们的装置与标准护理所需的插管时间。

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