Arterial Cannula with Permissive Distal Perfusion

描述(申请人提供)：提出了一种新的插管设计，以在动脉插管过程中提供远端灌流。动脉插管在体外血液处理的几个应用中很常见，例如动静脉二氧化碳清除(AVCO2R)治疗。AVCO2R是一种呼吸疗法，通过在简单的经皮动静脉分流术(即无泵)中利用低阻力气体交换器将氧合与二氧化碳清除分离，实现几乎全部的体外二氧化碳清除。就像在所有需要动脉插管的体外应用中一样，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流导管(DPC)，在插管顶端结合了一个3节球囊作为血管支撑，以及一个确保和调节远端流量的可变流量控制器。这种设计方法允许最大化插管尺寸，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。这里介绍的DPC为股骨插管提供了一种简单、可调整的解决方案，并将是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，利用计算技术和体外实验来设计远端灌流导管(DPC)，并充分表征原型。一个有功能的三节球囊原型已经完成，并验证了其优化远端和插管灌注的能力。第二阶段的目标是构建临床高质量的DPC，并在活体动物模型上验证该插管在优化远端血流方面是成功的，同时将并发症降至最低。在第二阶段结束时，将确定DPC的可制造性，并确定该设备的长期功能。这笔赠款将导致开发一种用于动脉插管的新型远端灌流插管(DPC)。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.