微创介入医疗程序中的模块化导管系统:案例研究

B. Beach, B. Scansen
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引用次数: 0

摘要

用于微创介入医疗程序的医疗器械导管都遵循相同的集成设计和使用模式。任何导管装置的特征和元件被组合在单个单一结构中。这些类型的介入导管的设计、构造和使用的模块化方法可以提供集成设计范式所不具备的显著优势和益处。本文旨在介绍模块化导管系统的设计,以及最初兽医使用的结果,作为模块化导管的总体潜力的案例研究。模块化导管系统使用市售血管成形术球囊扩张导管作为系统中的一个模块,并使用定制设计的评分适配器作为另一个模块。划线适配器包含电线,为血管成形术球囊导管添加划线功能,以提高肺动脉瓣成形术期间的扩张性能。划线适配器还包括一种新型连接机构,用于将划线适配器连接到任何0.035英寸导丝兼容的血管成形术球囊导管上。模块化导管系统已成功设计、制造并用于最初的微创兽医心血管干预,以治疗一例犬瓣膜下肺动脉狭窄。手术时,记分适配器和血管成形术球囊导管在手术室的桌旁成功结合,并用于成功扩张瓣下梗阻。所提出的模块化导管系统的成功设计和使用证明了这种模式的可行性和潜在优势,使医生能够在根据程序需求进行程序时创建介入导管设备。
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Modular Catheter Systems in Minimally Invasive Interventional Medical Procedures: Case Study
Medical device catheters that are used in minimally invasive interventional medical procedures all follow the same integrated design and use paradigm. The features and elements of any catheter device are combined in a single unitary construction. A modular approach to the design, construction, and use of these types of interventional catheters may provide significant advantages and benefits not available with an integrated design paradigm. This paper aimed to present the design of a modular catheter system and the findings from an initial veterinary use as a case study for the potential of modular catheter systems in general. A modular catheter system was designed using commercially available angioplasty balloon dilatation catheters as one module in the system and a custom designed scoring adapter as the other module. The scoring adapter incorporates wires to add scoring features to the angioplasty balloon catheter to improve the dilatation performance during a pulmonary valvuloplasty procedure. The scoring adapter also includes a novel attachment mechanism to couple the scoring adapter to any 0.035-inch guidewire–compatible angioplasty balloon catheter. The modular catheter system was successfully designed, manufactured, and used in an initial minimally invasive veterinary cardiovascular intervention to treat a case of canine subvalvular pulmonary stenosis. The scoring adapter and angioplasty balloon catheter were successfully combined tableside in the operating room at the time of the procedure and used to successfully dilate the subvalvular obstruction. The successful design and use of the presented modular catheter system demonstrates the feasibility and potential advantages of this type of paradigm to enable physicians to create interventional catheter devices at the time of a procedure guided by the procedural needs.
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