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。 因此，存在高比率的手术后并发症，诸如阴道组织瘢痕和阴道内分泌物。 狭窄我们建议创造新的阴道支架，其具有改进的贴合性、易用性、独特的展开和 检索机制，并提高舒适的儿科人口和那些妇女缩短 阴道 Biotex已经完成了SBIR第一阶段项目，在该项目中，我们创建了新型支架和展开机制， 完成实验室性能测试，并在体内动物试验期间评价多种设计配置 研究有希望的结果。我们的第二阶段提案的目标是通过创建 根据之前的临床前工作和医生输入更新了定制原型，测试设计正常 志愿受试者，锁定最终设计并完成FDA 510（k）备案所需的确认，以及测试 接受阴道重建手术的青少年和女性预期人群中的支架 在妇科癌症放射治疗后。我们相信这种新的阴道支架将减少术后 发病率，术后早期停止支架使用，降低医疗保健成本，并改善临床 为整个北美的女孩和妇女带来的成果。

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 completed a SBIR Phase I project where we created novel stents and deployment mechanisms, completed benchtop performance testing, and evaluated multiple design configurations during in vivo animal studies with promising results. The objectives of our Phase II proposal is to build on this work by creating updated custom prototypes based on prior pre-clinical work and physician input, test designs in normal volunteer subjects, lock down a final design and complete required validations for FDA 510(k) filing, and test the stents in the intended population of adolescents undergoing vaginal reconstructive surgery, and women after radiation treatment for gynecologic cancers. 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.