Hollow Fiber Catheter for Drug Delivery into the Prostate

描述(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。随着美国人口老龄化，前列腺增生症及其并发症的发病率和治疗费用都在迅速增长；前列腺癌是美国男性癌症死亡的第二大原因。显然，需要微创、成本效益高的疗法来匹配手术治疗方案的结果，而手术治疗方案与严重的发病率和并发症有关。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进一步开发MiHFC，并将现有的给药注射到人体前列腺的治疗计划方法结合起来，目标是开发一种可供人类临床使用的系统。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。这将允许研究人员将MiHFC设备用于其他涉及人类药物注射的研究项目，无论是否有治疗计划。假设：第二阶段正在开发的MiHFC注射系统将为泌尿科医生和研究人员提供一个更可靠的工具来计划和向人类前列腺注射疗法。初步数据：在第一阶段研究中，创新地使用申请人的MiHFC来改善注射到前列腺的药物输送是成功的，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。目标1：最终确定人类使用的MiHFC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。将进行人体体外和狒狒体内研究，以评估MiHFC的安全性和制剂分布，并开发前列腺特异性治疗计划系统。目标3：设计验证和510(K)提交。设计验证测试数据和FDA 510(K)许可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, particularly benign prostatic hyperplasia (BPH) and cancer. Both the incidence and cost of treatment for BPH, and its complications, are growing rapidly with the aging U.S. population; prostate cancer is the second-leading cause of cancer deaths among men in the U.S. 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 further developing MiHFC and combining existing treatment planning methods for drug delivery injections into human prostates with the objective to develop a system that is ready for human clinical use. 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, either with or without treatment planning. Hypothesis: The MiHFC injection system being developed in Phase II will give urologists and researchers a more reliable tool to plan and deliver injection therapies into the human prostate. Preliminary Data: In Phase I research, the innovative use of applicant's 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 use MiHFC 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 MiHFC safety and agent distribution and to develop of a prostate specific treatment planning system. Aim 3: Design verification and 510(k) submission. Design verification test data and FDA 510(k) clearance will facilitate clinical adoption and commercialization.