Instrumentation for Creating Biological Stents and Occlusions

描述（由申请人提供）：II期研究的具体目的是在动物模型中开发和测试微创微波球囊导管器械，用于在胰管和胆管中制造生物支架，以及在肝脏血管中制造生物闭塞。12头猪将被用于这项研究。目的是将胰管扩张到大约2-3毫米，超过其原有的大小，将胆总管扩张到更大的直径，有或没有人工产生的狭窄，并闭塞一些动物的肠系膜静脉和动脉拱桥。将进行大体和组织学检查，以及肝功能检查和影像学检查，以确定最佳治疗参数。经过处理的组织的温度将通过集成在气球中的微型热敏电阻和微波辐射计进行监测。其中几只动物将在术后三到六周的标准动物设施中饲养，并对手术可能产生的任何副作用进行监测和测试。动物实验的目的是为后续的临床试验奠定基础，这些临床试验使用微波球囊扩张胰腺和胆道狭窄，并在向肝脏肿瘤供血的血管中产生闭塞。微波球囊治疗肝狭窄，如果在动物实验中被证明是安全有效的，就有可能在肝狭窄的临床治疗中带来更好、更简单、更持久的治疗方法。同样，如果动物实验证明肝血管可以安全地产生持久的闭塞；这将有可能导致改善肝肿瘤的临床管理。当然，在任何临床试验和随后的商业化开始之前，都需要FDA的批准，因此该计划的一部分将用于启动FDA要求的额外动物研究，并开发符合FDA所有要求的原型仪器，用于后续临床试验。希望在拟议的II期项目中开发的微波球囊导管和仪器最终不仅可以用于生产胰管和胆管中的生物支架以及肝脏血管中的生物闭塞，还可以用于一般的扩张狭窄和闭塞血管，这些血管为各种实体恶性肿瘤提供血液。微波球囊导管仪器将由拟议的项目产生，使医生能够安全地扩大因疾病而狭窄的胰腺和胆管的直径，并关闭为肝癌提供食物的血管。该手术是微创的，并且可以在不需要将异物引入体内的情况下完成，这些异物有时会导致严重的副作用。

DESCRIPTION (provided by applicant): The specific aims of the Phase II research are the development and testing in an animal model of minimally invasive microwave balloon catheter instrumentation for producing biological stents in pancreatic ducts and bile ducts and for producing biological occlusions in blood vessels of the liver. Twelve pigs will be used in the study. The intent will be to dilate the pancreatic ducts to approximately 2-3 mm beyond their native size, to dilate the common bile ducts to larger diameters with and without artificially generated strictures, and to occlude the mesenteric venous and arterial arcades of some of these animals. Gross and histological examinations, as well as liver function tests and imaging will be performed to determine optimum treatment parameters. The temperatures of the treated tissues will be monitored with miniature thermistors that are integrated into the balloons and also with a microwave radiometer. Several of the animals will be maintained in standard animal facility for periods of three and six weeks postoperatively and monitored and tested for any side effects that may have resulted from the procedure. The animal studies are designed to lay the groundwork for follow- on clinical trials of the use of microwave ballooning for dilating pancreatic and biliary strictures and for producing occlusions in blood vessels that supply blood to hepatic tumors. Microwave ballooning of hepatic strictures, if proven to be safe and effective in the proposed animal studies has the potential to lead to better, less complicated, and more durable treatments in the clinical management of such strictures. Similarly, if the animal studies prove that lasting occlusions can be safely produced in hepatic blood vessels; this would have the potential to lead to improved clinical management of hepatic tumors. Since FDA approval is, of course, required before any clinical trials and subsequent commercialization can even begin, part of the program will be devoted to starting the additional animal studies that will be asked for by the FDA, and also to develop prototype instrumentation that will conform to all FDA requirements for use in follow-on clinical trials. The hope is that the microwave balloon catheters and instrumentation developed during the proposed Phase II program will eventually find application not only for producing biological stents in pancreatic ducts and bile ducts and biological occlusions in blood vessels of the liver, but also for dilating strictures in general and for occluding blood vessels that supply blood to a variety of solid malignant tumors. Relevance The microwave balloon catheter instrumentation that would result from the proposed program would enable physicians to safely enlarge the diameters of pancreatic and bile ducts that are narrowed by disease, and to close blood vessels that feed liver cancers. The procedure is minimally invasive, and could be accomplished without having to introduce foreign materials into the body, materials that can sometimes cause serious side effects. PUBLIC HEALTH RELEVANCE: Relevance The instrumentation that would result from the proposed program would enable physicians to safely enlarge the diameters of human canals, ducts and vessels that are narrowed by disease, or to close blood vessels that feed solid cancers. The physician will be able to accomplish this without having to introduce foreign materials into the body, materials that can sometimes cause serious side effects.