Improving Repair of Female Congenital and Reproductive Anomalies

项目摘要 这项SBIR建议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就患有先天性妇科异常，需要 手术重建她们的阴道腔。也有一些女性身材非常矮小或伤痕累累 盆腔手术或癌症放射治疗后的阴道。新阴道置入后可使用阴道支架 创造防止疤痕和再狭窄。目前还没有可用的阴道支架符合 妇科癌症治疗后儿童和青春期女孩或妇女的解剖学需求。AS 因此，术后并发症的发生率很高，如阴道组织瘢痕和阴道狭窄。 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 为儿科人群和阴道缩短的妇女提供更好的舒适性。 BioTex已经与德克萨斯州儿童医院的合作医生达成了一项期权协议 (贝勒医学院)根据我们的临床申请正在申请的专利创造新设计的支架 合作者。我们第一阶段提案的目标是构建全功能原型，进行台式 测试，并在猪阴道中进行活体研究，以证明支架的性能。我们 相信这种新的阴道支架将降低手术后的发病率，尽早停止使用支架 术后，降低医疗保健成本，改善北方女孩和妇女的临床结果 美国。

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.