Local Hyperthermia Catheter for Enhanced Ablation and Cancer Therapy

描述（由申请人提供）：本SBIR资助提案第一阶段的目标是开发一种新的设备和方法，用于在计划的热消融之前局部升高靶组织的温度，我们称之为“超消融”。在初步工作中，我们证明了将靶组织的预处理温度提高100 ℃会导致体积消融尺寸增加60%。其他人已经显示了栓塞或其他方法在消融术前减少血流对流冷却的益处。所提出的超消融装置将提供一种独特的方式来实现这两种策略，并应导致热消融效率的显着增加。该技术的应用可以超越消融，并且证明在正在研究热疗的许多领域中是有用的，例如热激活脂质体化疗、区域化疗和高血压增强放射程序。 我们将寻求临床合作者的意见，并进行建模模拟，以指导热疗导管的设计。我们将采购材料，制造原型，并使用生理条件和组织样本在台式装置中测试器械。最后，我们将与介入放射学的临床专家合作，在大型动物模型中测试该设备，并评估这种治疗方法在肝脏热消融背景下的性能和潜在益处。在这个项目结束时，我们将确定使用该设备创建局部热疗的可行性，并了解这种方法的潜在好处和应用。 公共卫生相关性：SBIR第一阶段资助计划的目标是开发一种新型导管技术，能够在消融手术前诱导局部高温并停止血流。该系统将有助于增强消融区的大小，并可能与其他化疗和放射治疗方案的应用。该提案的重点是在实验室和试验动物研究中设计、制造和测试原型器械

DESCRIPTION (provided by applicant): The goal of this Phase I SBIR Grant Proposal is to develop a new device and methodology for local elevation of a target tissue's temperature prior to a planned thermal ablation, a process we've dubbed "hyperablation". In preliminary work we demonstrated that raising the pre-treated temperature of a target tissue by 100C resulted in a 60% increase in volumetric ablation size. Others have shown the benefits of embolization or other methods to decrease convective cooling from blood flow prior to an ablation procedure. The proposed hyperablation device would provide a unique way to accomplish both strategies and should lead to a significant increase in thermal ablation efficiency. Application of this technology may go beyond ablation and prove useful in a number of areas where hyperthermia is being investigated such as heat- activated liposomal chemotherapy, regional chemotherapy, and hyperthermia-enhanced radiation procedures. We will seek input from clinical collaborators and perform modeling simulations to guide the design of the hyperthermia catheter. We will source materials, fabricate prototypes, and test the device in a benchtop setup using physiologic conditions and tissue samples. Finally, we will work with clinical experts in interventional radiology to test the device in a large animal model and evaluate the performance and potential benefits of this treatment approach in the context of thermal ablation in the liver. At the end of this project, we will have determined the feasibility of creating local hyperthermia with this device and understand the potential benefits and applications for this approach. PUBLIC HEALTH RELEVANCE: The goal of this Phase I SBIR Grant proposal is to develop a novel catheter technology capable of inducing local hyperthermia and halting blood flow prior to an ablation procedure. The system will be useful for enhancing ablation zone size and may find application with other chemotherapy and radiation based protocols. This proposal is focused on design, fabrication, and testing of a prototype device in benchtop and pilot animal studies