Hollow Fiber Catheter for Drug Delivery into the Prostate

用于将药物输送到前列腺的中空纤维导管

• 批准号: 8804067
• 负责人: Jim Stice
• 金额: $ 64.18万
• 依托单位: TWIN STAR TDS, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8804067
• 关键词: Hollow; Fiber; Catheter; Drug; Delivery

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.

描述（由申请人提供）：拟议研究的意义是基于对医疗保健资源的日益增长的需求，以治疗和管理前列腺疾病，特别是良性前列腺增生（BPH）和癌症。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，前列腺癌的发病率和BPH及其并发症的治疗费用都在迅速增长。显然需要微创、具有成本效益的疗法来匹配与显著发病率和并发症相关的外科治疗选择的结果。前列腺注射尚未成为护理标准，因为用针头分发药物不足。申请人已经开发了一种用于改善前列腺中的注射分布的微孔中空纤维导管（MiHFC）。第二阶段的创新重点是将现有的治疗计划方法与MiHFC结合起来，用于将药物输送注射到人类前列腺中，目的是开发的系统将准备用于人类临床使用。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一个更可靠的工具，以计划和提供注射治疗到人类前列腺。相同的MiHFC装置具有小的变化，可适用于需要改进的注射系统的许多其他人类临床应用，例如肝脏、肾脏和其他实体器官。这将使研究人员能够将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。初步数据：在I期研究中，创新性地使用申请人的微孔中空纤维导管（MiHFC）来改善注射药物递送到前列腺中是成功的，与针注射相比，MiHFC显著改善了犬前列腺中的乙醇分布。具体目标：本II期提案的目的是进一步开发申请人的创新药物递送系统，以改善前列腺疾病治疗，并提供实验室和动物研究数据，以加速其临床应用。目的1：最终确定人体研究导管设计。第一阶段MiHFC设计将进行优化，以满足根据用户要求制定的人类使用规范。目的2：输注研究和分析。将进行人离体和狒狒体内研究，以评估药物分布，用于开发治疗计划系统。目标3：设计验证和510（k）提交。FDA 510（k）批准将促进临床采用和商业化。