权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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

基本信息

批准号：
9084779
负责人：
Jim Stice
金额：
$ 0.5万
依托单位：
TWIN STAR TDS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-06-01 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9084779
关键词：
Adoption Aging Animals Area Benign Prostatic Hypertrophy Cancer Etiology Canis familiaris Catheters Cessation of life Clinical Computer software Data Development Devices Disease Drug Delivery Systems Dyes Ethanol Evaluation Fiber Health Healthcare Human Image Incidence Infusion procedures Injection of therapeutic agent Kidney Knowledge Lead Light Liver Magnetic Resonance Malignant Neoplasms Malignant neoplasm of prostate Methods Methylene blue Modeling Modification Morbidity - disease rate Needles Operative Surgical Procedures Oral Organ Outcome Papio Performance Pharmaceutical Preparations Phase Population Prostate Prostatic Diseases Research Research Methodology Research Personnel Research Project Grants Resources Safety Science Solid Structure System Testing Therapeutic Time Treatment Cost Urethra Urologist aging population base clinical application clinical practice commercialization cost effective design drug distribution effective therapy human study improved in vivo innovation insight meetings men minimally invasive standard of care tool treatment planning

项目摘要

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.

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。BPH及其并发症的发病率和治疗成本随着美国人口老龄化而迅速增长;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、具有成本效益的治疗方法来匹配与显著发病率和并发症相关的手术治疗方案的结果。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进一步开发MiHFC，并将现有的药物输送注射到人类前列腺中的治疗计划方法结合起来，目的是开发一种可供人类临床使用的系统。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使用MiHFC设备进行涉及人类药物注射的其他研究项目，无论是否有治疗计划。假设：正在第二阶段开发的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，以计划和提供注射治疗到人类前列腺。初步数据：在I期研究中，申请人的MiHFC用于改善注射药物递送到前列腺中的创新使用是成功的，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。目标1：完成人类使用MiHFC的设计。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。将进行人类离体和狒狒体内研究，以评估MiHFC的安全性和药物分布，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。