SBIR Phase I: A Diagnostic Catheter for Treating Obstructions/Occlusions Within a Body Lumen or Vessel

这个SBIR第一阶段项目旨在设计和开发一种创新的医疗设备解决方案，通过减少程序时间和减少外周血管介入程序中使用的导管和设备数量，潜在地为整个美国医疗系统节省11.6亿美元。仅在美国，下肢外周动脉疾病就影响了800多万人。每年用于治疗外周动脉疾病的医疗支出为43.7亿美元。自2008年以来，美国医疗保险和医疗补助中心一直强调提高外周血管介入治疗的效率和降低成本。在常规的外周血管介入治疗中，在治疗PAD时，会遇到导丝通路丢失的情况。这种并发症在难以跨越狭窄病变的情况下会被放大，在许多情况下，这对医生来说是令人沮丧的，因为他们不得不花费几个小时/程序试图重新获得导丝通道。导丝通路是手术成功的关键。该项目旨在通过消除当前实践中的导丝/导管交换来提高程序效率，从而降低Cath实验室的管理费用，并通过减少获得高质量血管造影图像所需的程序时间和精力来降低外周血管干预成本。这项创新的一个重要的辅助好处是，由于荧光透视活动的减少，可能会将对医疗保健提供者和患者的辐射暴露降至最低。该项目的目标是在SBIR第一阶段之后继续成为商业产品并成为外周血管介入手术护理的标准。这一SBIR第一阶段项目是设计和开发一种0.014英寸导丝兼容的低轮廓PTA球囊导管，具有专有的对比剂注射机制。这款产品非常适合在困难的解剖空间进行PTA干预，例如膝下周围血管系统。专有的充气和注射系统允许在不需要更换导管或失去导丝接入的情况下进行治疗可视化。该项目的成果旨在沿着整个治疗长度提供聚焦和更清晰的可视化，并允许在对比度敏感的患者中明智地使用不透射线对比剂。这一概念的可行性原型在动物模型中进行了测试，结果令人振奋。该项目第一阶段的重点是克服技术挑战，设计和开发独特的设备设计，以维持统计上显著的额定破裂压力，根据国际标准化组织标准10555-1 2013年开发和评估设备粘接接头，无菌一次性使用血管内导管，开发制造工艺和工具，以集成导管的多功能。该项目旨在设计和制造一种测试夹具，以根据FDA II类经皮球囊导管指导控制模拟创新设备的临床使用，并确认该导管满足客户要求。作为SBIR第一阶段项目的一部分，开发工作涉及使用迭代设计过程。3维设计建模和优化，创建测试夹具以模拟临床使用，迭代原型和测试工作以确保所需的设备规格符合要求。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

This SBIR Phase I project intends to design and develop an innovative medical device solution that can potentially save $1.16B to the overall US healthcare system by reducing the procedural time and decreasing the number of catheters and devices used in Peripheral Vascular lnterven6on procedures. Lower extremity peripheral arterial disease affects more than 8 million people in the United States alone. The annual healthcare expenditure spent on treating peripheral arterial disease is $4.37B. Since 2008, US Center for Medicare and Medicaid has been stressing for greater efficiency and lowering costs for Peripheral Vascular Intervention. Commonly performed Peripheral Vascular Intervention procedures in the CathLab, to treat PAD, encounter loss of guidewire access. This complication is amplified in the case of difficult to cross stenotic lesions and, in many cases, is frustrating for the physician as they have to spend several hours/procedures trying to regain guidewire access. Guidewire access is the key for a successful procedural outcome. The Project intends to reduce Peripheral Vascular Intervention cost by improving procedural efficiency by eliminating guidewire/catheter exchanges in current practice thereby reducing Cath Lab overhead costs and by reducing procedure time and effort required to acquire a good quality angiographic image. An important ancillary benefit of the innovation is that the radiation exposure to the healthcare providers and the patient can potentially be minimized due to the decreased fluoroscopic activity. The project aims to continue beyond SBIR Phase I to become a commercial product and be the standard of care for Peripheral Vascular Intervention procedures.This SBIR Phase I project is for the design and development of a .014-inch guidewire compatible low profile PTA balloon catheter with a proprietary contrast injection mechanism. This product is ideal for performing PTA interventions in difficult anatomical spaces e.g. below-the-knee peripheral vasculature. The proprietary inflation and injection system allows for treatment visualization without needing catheter exchanges or loss of guidewire access. The output of the Project intends to provide focused and sharper visualization along the entire treatment length and allows for judicious usage of radiopaque contrast in contrast sensitive patients. A feasibility prototype of the concept was tested in an animal model with promising results. The SBIR Phase I project is focused on overcoming technical challenges to design and develop the unique device design to maintain a statistically significant rated burst pressure, develop and evaluate device bond joints per ISO standard 10555-1 2013, Sterile Single Use Intravascular catheters, develop the manufacturing process and tools, to integrate the catheter multi functionality. The Project intends to design and fabricate a test fixture to simulate clinical usage of the Innovative device per FDA Class II Guidance Controls for Percutaneous Transluminal Balloon Catheters and confirm that the catheter satisfies customer requirements. The Development efforts as part of SBIR Phase I project involve utilization of iterative design process. 3-dimensional design modeling and optimization, creation of a test fixture to simulate clinical usage, iterative prototyping and testing efforts to ensure the desired device specifications are met.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.