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生产生物支架，以及在肝脏血管中生产生物闭塞。本研究将使用12头猪。目的是将胰管扩张至超过其天然尺寸约2-3 mm，将胆总管扩张至更大直径（有或无人工产生的狭窄），并闭塞其中一些动物的肠系膜静脉和动脉弓。将进行大体和组织学检查以及肝功能检查和成像，以确定最佳治疗参数。将使用集成到球囊中的微型热敏电阻和微波辐射计监测治疗组织的温度。几只动物将在术后3周和6周内在标准动物设施中饲养，并监测和检测手术可能导致的任何副作用。动物研究旨在为使用微波球囊扩张胰腺和胆管狭窄以及在向肝肿瘤供血的血管中产生闭塞的后续临床试验奠定基础。如果在拟定的动物研究中证明肝狭窄的微波球囊扩张术安全有效，则有可能在此类狭窄的临床管理中获得更好、更简单和更持久的治疗。同样，如果动物研究证明可以在肝血管中安全地产生持久的闭塞，这将有可能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批准，因此该计划的一部分将致力于启动FDA要求的额外动物研究，并开发符合所有FDA要求的原型仪器，用于后续临床试验。希望是，在拟议的第二阶段计划期间开发的微波球囊导管和仪器最终将不仅用于生产胰管和胆管中的生物支架和肝脏血管中的生物闭塞，而且还用于扩张一般狭窄和闭塞向各种实体恶性肿瘤供血的血管。相关性微波球囊导管仪器，将导致从拟议的计划将使医生能够安全地扩大直径的胰腺和胆管狭窄的疾病，并关闭血管，饲料肝癌。该手术是微创的，并且可以在不必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。 公共卫生相关性：相关性拟议计划产生的仪器将使医生能够安全地扩大因疾病而变窄的人体管道、导管和血管的直径，或关闭滋养实体癌的血管。医生将能够做到这一点，而不必将异物引入体内，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.