Improving Repair of Female Congenital and Reproductive Anomalies

改善女性先天性和生殖异常的修复

基本信息

批准号：
9466595
负责人：
Ashok Gowda
金额：
$ 22.5万
依托单位：
BIOTEX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-20 至 2018-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9466595
关键词：
Address Adolescent Adult Aftercare Agreement Anatomic Models Anatomy Animal Model Animals Biomechanics Cancer Patient Childhood Cicatrix Clinical Clinical Research Coupling Devices Economic Inflation Engineering Family suidae Female Female Adolescents Fingers Geometry Goals Gynecologic Gynecology Health Care Costs Hour Image Analysis In Situ Injury Left Legal patent Length Magnetism Malignant Female Reproductive System Neoplasm Medical Device Medicine Morbidity - disease rate Movement Necrosis North America Numeric Rating Scale Operative Surgical Procedures Outcome Parents Patients Pediatric Hospitals Pelvis Performance Phase Physicians Population Positioning Attribute Postoperative Complications Postoperative Period Preparation Problem Solving Process Property Radiation Radiation therapy Recovery Retrieval Small Business Innovation Research Grant Stenosis Stents Sterility Surgical complication Testing Texas Time Tissues Traction United States Vagina Woman base cancer therapy college design girls healing improved in vivo irritation novel operation pressure prevent prototype reconstruction repaired reproductive restenosis time use young woman

项目摘要

Project Summary The overall goal of this SBIR proposal is to develop a novel vaginal stent for use in pediatric and adult populations. There are many girls and women born with congenital gynecologic abnormalities requiring surgical reconstruction of their vaginal cavities. There are also women who have very shortened or scarred vaginas after pelvic surgery or radiation treatment for cancer. Vaginal stents can be used after neo-vagina creation to prevent scarring and re-stenosis. There are no currently available vaginal stents that meet the anatomic needs of pediatric and adolescent girls or women who are post treatment for gynecologic cancers. As such, there is a high rate of post-surgical complications such as vaginal tissue scaring and vaginal stenosis. We propose to create new vaginal stents with improved fit, ease of use, unique deployment and retrieval mechanisms, and enhanced comfort for a pediatric population and for those women with shortened vaginas. BioTex has entered into an option agreement with collaborating physicians at Texas Children’s Hospital (Baylor College of Medicine) to create the newly designed stent based on pending patents filed by our clinical collaborators. The objectives of our Phase I proposal is to build fully functional prototypes, conduct benchtop testing, and perform in vivo studies in porcine vaginal tracts to demonstrate performance of the stents. We believe this new vaginal stent will reduce post-surgical morbidity, early discontinuation of stent use postoperatively, reduce health care costs, and improve clinical outcomes for girls and women across North America.

项目概要该 SBIR 提案的总体目标是开发一种用于儿科和成人的新型阴道支架许多女孩和妇女出生时就患有先天性妇科异常。也有一些女性的阴道腔非常短或有疤痕。盆腔手术或癌症放射治疗后的阴道阴道支架可在新阴道后使用。目前尚无符合要求的阴道支架。儿科和青春期女孩或妇科癌症治疗后妇女的解剖学需求。因此，术后并发症的发生率很高，例如阴道组织疤痕和阴道狭窄。我们建议创建新的阴道支架，具有改进的贴合性、易用性、独特的部署和回收能力机制，并提高儿科人群和阴道缩短的女性的舒适度。 BioTex 已与德克萨斯儿童医院的合作医生签订了一份选择协议（贝勒医学院）根据我们临床申请的待决专利创建新设计的支架我们第一阶段提案的目标是构建功能齐全的原型，进行台式测试。我们在猪阴道中进行测试并进行体内研究，以证明支架的性能。相信这种新的阴道支架将减少术后发病率，尽早停止使用支架术后，降低医疗保健成本，并改善北部地区女孩和妇女的临床结果美国。