Arterial Cannula with Permissive Distal Perfusion

描述（由申请人提供）：提出了一种新型插管设计，用于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是常见的，例如动静脉二氧化碳去除（AVCO2R）治疗。AVCO2R是一种呼吸治疗，通过在简单的经皮动静脉分流（即无泵）中使用低阻力气体交换器，将氧合与CO2清除分离，以实现几乎完全体外清除CO2产生。与所有需要动脉插管的体外应用一样，可能会发生感染和远端缺血等并发症。介绍了一种独特的远端灌注套管（DPC），其中套管尖端包含一个3节球囊，用作血管支撑，以及一个可变流量控制器，可确保和调节远端流量。这种设计方法允许套管尺寸最大化，从而最大限度地减少体外回路的阻力，同时确保患者的安全。本文所述的DPC为股动脉插管提供了一种简单、可调节的解决方案，并将成为AVCO2R以及其他体外支持治疗的采用和有效性的关键。在第一阶段，计算技术和体外实验用于设计远端灌注套管（DPC），并充分表征原型。已完成功能性3节段球囊原型，并验证了其优化远端和插管灌注的能力。第II阶段的目的是构建临床质量DPC，并验证插管在体内动物模型上成功优化远端血流，同时最大限度地减少并发症。在第II阶段结束时，将定义DPC的可制造性，并确定器械的长期功能。该基金将用于开发一种用于动脉插管的新型远端灌注套管（DPC）。新DPC将优化体外回路的性能，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.