Hollow Fiber Catheter for Drug Delivery into the Prostate

描述（由申请人提供）：拟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（BPH）和癌症的医疗资源日益增长的需求。随着美国人口的老龄化，前列腺增生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、低成本的治疗方法来匹配手术治疗选择的结果，这与显著的发病率和并发症有关。由于针头药物分配不足，前列腺注射尚未成为标准治疗。申请人已经开发了一种微孔中空纤维导管（MiHFC），用于改善前列腺内的注射分布。II期创新的重点是进一步开发MiHFC，并结合现有的治疗计划方法，将药物注射到人类前列腺中，目的是开发一种可供人类临床使用的系统。同样的MiHFC设备经过微小的改变，将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、肾脏和其他实体器官。这将允许研究人员在其他涉及人体药物注射的研究项目中使用MiHFC设备，无论是否有治疗计划。假设：MiHFC注射系统正处于二期研究阶段，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治疗。初步数据：在I期研究中，申请人的MiHFC用于改善注射药物进入前列腺的创新使用是成功的，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：该II期申请的目标是进一步开发申请人的创新给药系统，以改善前列腺疾病的治疗，并提供实验室和动物研究数据，以加速其临床应用。目标1：最终确定人用MiHFC设计。一期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范。目的2：输液研究和分析。将进行人类离体和狒狒体内研究，以评估MiHFC的安全性和药物分布，并制定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)许可将促进临床应用和商业化。

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.