Hollow Fiber Catheter for Drug Delivery into the Prostate

描述(由申请人提供)：建议研究的意义是基于对治疗和管理前列腺疾病，特别是良性前列腺增生症(BPH)和癌症的医疗资源日益增长的需求。前列腺癌是美国男性癌症死亡的第二大原因，随着美国人口老龄化，前列腺癌的发病率、治疗BPH的费用及其并发症都在迅速增长。显然，需要微创、经济有效的治疗方法来匹配手术治疗方案的结果，因为手术治疗方案与显著的发病率和并发症相关。由于针头药物分配不充分，前列腺注射尚未成为标准护理。申请人开发了一种微孔中空纤维导管(MiHFC)，用于改善前列腺中的注射分布。第二阶段的创新侧重于将现有的治疗计划方法与MiHFC结合起来，将药物注射到人体前列腺中，目标是开发的系统将准备好供人类临床使用。假设：正在第二阶段开发的注射系统，包括MiHFC和治疗计划软件，将为泌尿科医生和研究人员提供更可靠的工具，计划和提供注射疗法到人类前列腺。同样的MiHFC设备只要有很小的改变，就可以适用于许多其他需要改进注射系统的人类临床应用，如肝脏、肾脏和其他固体器官。这将允许研究人员在有或没有治疗计划的情况下，将MiHFC设备用于其他涉及人类药物注射的研究项目。初步数据：在第一阶段研究中，创新地使用申请人的微孔中空纤维导管(MiHFC)来改善前列腺内的注射药物输送是成功的，与针头注射相比，MiHFC显著改善了乙醇在犬前列腺中的分布。具体目标：这项第二阶段提案的目标是进一步开发申请人的创新药物输送系统，以改进前列腺癌的治疗方法，并提供实验台和动物研究数据，以加快其临床应用。目的1：最终确定人体研究导管设计。第一阶段的MiHFC设计将进行优化，以满足根据用户需求建立的人类使用规格。目的2：输液研究与分析。为了开发治疗计划系统，将进行人类体外和狒狒体内研究，以评估药物分布。目标3：设计验证和510(K)提交。FDA 510(K)的批准将促进临床采用和商业化。

DESCRIPTION (provided by applicant): The significance of the proposed research is based on the growing demand for healthcare resources to treat and manage prostatic disease, in particular benign prostatic hyperplasia (BPH) and cancer. Prostate cancer is the second-leading cause of cancer deaths among men in the U.S, and both the disease's incidence and cost of treatment for BPH, and its complications, are growing rapidly with the aging U.S. population. There is a clear need for minimally invasive, cost-effective therapies to match the outcomes of surgical treatment options, which are associated with significant morbidity and complications. Prostate injections have not become standard of care due to inadequate drug distribution with needles. The applicants have developed a microporous hollow fiber catheter (MiHFC) for improved injection distribution in the prostate. Phase II innovations focus on combining existing treatment planning methods with MiHFC for drug delivery injections into human prostates with the objective that the system developed will be ready for human clinical use. Hypothesis: The injection system being developed in Phase II, including MiHFC and treatment planning software will give urologists and researchers a more reliable tool to plan and deliver injection therapies into the human prostate. The same MiHFC device with small changes would be adaptable for use in many other human clinical applications needing improved injection systems, such as liver, kidney and other solid organs. This would allow researchers to use MiHFC devices for other research projects involving human drug injections with or without treatment planning. Preliminary Data: In Phase I research, the innovative use of applicant's microporous hollow fiber catheters (MiHFC) to improve injection drug delivery into the prostate was successful with MiHFC significantly improving ethanol distribution in canine prostates as compared to needle injections. Specific Aims: The objective of this Phase II proposal is to further develop the applicant's innovative drug delivery system for improved prostate disease therapies and to provide the bench and animal study data to accelerate its clinical use. Aim 1: Finalize human study catheter design. The Phase I MiHFC design will be optimized to meet human use specifications established from user requirements. Aim 2: Infusion studies and analysis. Human ex vivo and baboon in vivo studies will be conducted to assess agent distribution for the development of a treatment planning system. Aim 3: Design verification and 510(k) submission. FDA 510(k) clearance will facilitate clinical adoption and commercialization.