Improving Repair of Female Congenital and Reproductive Anomalies

项目摘要 SBIR提案的总体目标是开发一种用于儿童和成人的新型阴道支架。 人口。有许多女孩和妇女出生时患有先天性妇科异常， 阴道腔的外科重建。也有妇女谁非常缩短或疤痕 盆腔手术或癌症放射治疗后的阴道。新阴道术后可使用阴道支架 以防止瘢痕形成和再狭窄。目前没有可用的阴道支架满足 儿科和青春期女孩或妇科癌症治疗后妇女的解剖需求。作为 因此，术后并发症如阴道组织瘢痕和阴道狭窄的发生率很高。 我们建议创造新的阴道支架，具有更好的适合性，易用性，独特的部署和回收 机制，并为儿科人群和阴道缩短的女性提供更高的舒适度。 BioTex已与德克萨斯儿童医院的合作医生签订了一项选择协议 （贝勒医学院）创建新设计的支架的基础上，申请专利的临床 合作者我们的第一阶段提案的目标是建立功能齐全的原型， 测试，并在猪阴道中进行体内研究，以证明支架的性能。我们 我相信这种新的阴道支架将降低术后发病率， 手术后，降低医疗保健成本，改善北卡罗来纳州女孩和妇女的临床结果， 美国参考

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.