BIOLOGICAL STENTS FOR TREATING BPH

该计划的长期目标是发展 能够安全有效治疗良性前列腺的器械 在不使用麻醉的情况下，在单次会议中进行肥大[BPH]。 的 拟议的仪器将微波加热与球囊扩张相结合 在尿道内制造出持久的生物支架。的安全 通过控制所施加的微波功率来确保该过程， 热电偶和微波辐射计，可以非侵入性 测量所治疗的前列腺中的温度曲线。 在阶段 开发并测试了适用于动物试验的仪器， 组织等效体模。在后I期实验中，前列腺 的四只狗被扩张并用微波加热以治疗 温度所有犬的直肠始终保持安全 温度一个开放的前列腺尿道[生物支架]， 在一只狗的切开的前列腺中测量到直径为6mm。期间 拟议的第二阶段计划、仪器和治疗方案 将在使用20只狗的实验中进行优化， 将制造适合于未来在临床试验中使用的材料。 拟议的商业应用： 所提出的治疗BPH的方法预计是安全、有效的， 成本更低，副作用更少。 由于这些优点，它应该找到广泛接受泌尿科医生 和病人。该治疗方法由美国专利所涵盖， 主要研究者，分配至MMTC，Inc.微波辐射计 由主要研究者获得的专利所涵盖， 分配给MMTC，Inc.也将纳入该系统。

The long-term objective of the proposed program is to develop instrumentation that can safely and effectively treat benign prostatic hypertrophy [BPH] in a single session without the use of anesthesia. The proposed instrumentation combines microwave heating with balloon dilation to produce long-lasting biological stents in the urethra. The safety of the procedure is assured by controlling the applied microwave power with thermocouples and with a microwave radiometer that can non-invasively measure temperature profiles in the treated prostate gland. During Phase I instrumentation suitable for animal trials was developed and tested in tissue equivalent phantoms. In post Phase I experiments, the prostates of four dogs were dilated and heated with microwaves to therapeutic temperatures. The rectums of all dogs remained at all times at safe temperatures. A patent prostatic urethra [biological stent] with a diameter 6mm was measured in the dissected prostate of one dog. During the proposed Phase II program, instrumentation and treatment protocols will be optimized in experiments using 20 dogs, and instrumentation suitable for future use in clinical trials will be fabricated. PROPOSED COMMERCIAL APPLICATIONS: The proposed approach for treating BPH is expected to be safe, effective, lower in cost, and produce fewer side effects than current approaches. Because of these advantages, it should find wide acceptance by urologists and patients. The treatment is covered by a US patent issued to the Principal Investigator and assigned to MMTC, Inc. Microwave radiometers that are covered by patents issued to the Principal Investigator and assigned to MMTC, Inc. will also be incorporated into the system.