Instrumentation for Creating Biological Stents and Occlusions

用于制造生物支架和闭塞的仪器

• 批准号: 8139878
• 负责人: FRED STERZER
• 金额: $ 38.06万
• 依托单位: MMTC, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8139878
• 关键词: Adverse effects; Amylases; Animal Model; Animals; Area; Biliary; Biological; Blood Vessels; Body of pancreas; Caliber; Catheters; Clinical Management; Clinical Trials; Common bile duct structure; Complete Blood Count; Disease; Duct (organ) structure; Family suidae; Head; Hepatic; Histologic; Human; Image; In Vitro; Institutional Review Boards; Intake; Lead; Lipase; Liver; Liver Function Tests; Malignant Neoplasms; Malignant neoplasm of liver; Measurement; Measures; Mesentery; Modeling; Monitor; Output; Pancreas; Pancreatic duct; Phase; Philadelphia; Physicians; Procedures; Recovery; Research; Research Design; Serum; Solid; Stents; Surgeon; Technology; Temperature; Testing; Time; Tissues; Universities; Vascular blood supply; Venous; animal care; animal facility; base; bile duct; commercialization; experience; feeding; follow-up; improved; in vitro testing; in vivo; instrument; instrumentation; male; microwave electromagnetic radiation; minimally invasive; professor; programs; prototype; public health relevance; research and development; success; tumor

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.

描述(申请人提供)：第二阶段研究的具体目标是在动物模型中开发和测试微创微波球囊导管器械，用于在胰管和胆管产生生物支架，并在肝脏血管产生生物闭塞。这项研究将使用12头猪。其目的是将胰管扩张到比正常大小约2-3毫米，将胆总管扩张到更大的直径，并在有或没有人工造成狭窄的情况下，以及阻断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，以及肝功能测试和成像，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。其中几只动物将在手术后的标准动物设施中维持三到六周的时间，并监测和测试该程序可能产生的任何副作用。这些动物研究旨在为后续的临床试验奠定基础，这些临床试验将使用微波气球扩张胰腺和胆道狭窄，并在为肝脏肿瘤提供血液的血管中产生闭塞。如果在拟议的动物研究中被证明是安全有效的，微波气囊肝狭窄成形术有可能导致临床治疗此类狭窄的更好、更少复杂和更持久的治疗。同样，如果动物研究证明可以安全地在肝血管中产生持久的闭塞，这将有可能导致改善肝肿瘤的临床治疗。当然，由于在开始任何临床试验和随后的商业化之前都需要FDA的批准，该计划的一部分将专门用于启动FDA要求的额外动物研究，并开发符合FDA所有要求的原型器械，用于后续临床试验。人们希望，在拟议的第二阶段计划期间开发的微波球囊导管和器械最终将不仅应用于生产胰管和胆管的生物支架和肝脏血管的生物闭塞，而且还用于扩张狭窄和闭塞为各种实体恶性肿瘤供应血液的血管。相关：建议中的计划所产生的微波球囊导管器械将使医生能够安全地扩大因疾病而变窄的胰腺和胆管的直径，并关闭供养肝癌的血管。这一过程是微创的，可以在不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：拟议中的计划将带来的器械将使医生能够安全地扩大因疾病而变窄的人体管道、管道和血管的直径，或关闭供实体癌症患者使用的血管。医生将能够在不将异物引入体内的情况下完成这一任务，这些异物有时会导致严重的副作用。