Arterial Cannula with Permissive Distal Perfusion

描述（由申请人提供）：提出一种新颖的导管设计，在动脉插管期间提供远端灌注。动脉插管在体外血液处理的几种应用中很常见，例如动静脉二氧化碳去除（AVCO2R）治疗。AVCO2R是一种呼吸治疗方法，通过在简单的经皮动静脉分流术（即无泵）中使用低阻力气体交换器来分离二氧化碳去除中的氧合，以实现几乎完全的体外去除二氧化碳产生。在所有需要动脉插管的体外应用中，可能会发生感染和远端缺血等并发症。本文介绍了一种独特的远端灌注插管（DPC），其中导管尖端的3节球囊作为血管支撑，以及可变流量控制器，以确保和调节远端血流。这种设计方法可以使套管尺寸最大化，从而最大限度地减少体外电路的阻力，同时确保患者的安全。本文描述的DPC为股骨插管提供了一种简单、可调节的解决方案，并将成为AVCO2R以及其他体外支持疗法的采用和疗效的关键。在第一阶段，采用计算技术和体外实验来设计远端灌注套管（DPC），并对原型进行全面表征。一个功能性的3段球囊原型已经完成，并验证了其优化远端和插管灌注的能力。II期的目标是构建临床质量的DPC，并在体内动物模型上验证该套管成功地优化了远端血流，同时最大限度地减少了并发症。在第二阶段结束时，将定义DPC的可制造性，并确定设备的长期功能。这项资助将导致一种用于动脉插管的新型远端灌注插管（DPC）的发展。新的DPC将优化体外电路的性能，同时确保患者的安全。

DESCRIPTION (provided by applicant): A novel cannula design is proposed to provide distal perfusion during arterial cannulation. Arterial cannulation is common in several applications of extracorporeal blood processing, such as ArterioVenous Carbon Dioxide Removal (AVCO2R) treatment. AVCO2R is a respiratory treatment that uncouples oxygenation from CO2 removal by utilizing a low-resistance gas exchanger in a simple percutaneous arteriovenous shunt (i.e. pumpless) to achieve near-total extracorporeal removal of CO2 production. As in all extracorporeal applications that require arterial cannulation, complications such as infection and distal ischemia can occur. A unique distal perfusion cannula (DPC) is presented, where a 3-section balloon incorporated at the tip of the cannula acts as a vessel support, as well as a variable flow controller that ensures and regulates distal flow. This design approach allows for the cannula size to be maximized, which minimizes the resistance of the extracorporeal circuit, while ensuring safety for the patient. The DPC described here offers a simple, adjustable solution to femoral cannulation and will hold the key to the adoption and efficacy of AVCO2R, as well as other extracorporeal support therapies. In Phase I, computational techniques and in vitro experiments were used to design the distal perfusion cannula (DPC), and to fully characterize the prototypes. A functional, 3-section balloon prototype has been completed and verified of its ability to optimize both distal and cannula perfusion. The objective of Phase II is to construct a clinical quality DPC, and to verify that the cannula is successful in optimizing distal flow while minimizing complications on an in vivo animal model. At Phase II conclusion, manufacturability of the DPC will be defined, and the long-term functionality of the device will be determined. This grant will result in the development of a novel distal perfusion cannula (DPC) for use in arterial cannulation. The new DPC will optimize the performance of an extracorporeal circuit, while ensuring safety for the patient.