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。 因此，手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 恢复机制，并增强了对儿科人口和那些患有矮小的妇女的舒适度 阴道。 Biotex已经完成了SBIR第一阶段项目，在该项目中，我们创造了新的支架和展开机制， 完成了台式性能测试，并在活体动物实验中评估了多种设计配置 结果令人振奋的研究。我们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的输入更新定制原型，测试设计正常 志愿者，锁定最终设计，完成FDA 510(K)备案所需的验证，并进行测试 接受阴道重建手术的青少年和女性预期人群中的支架 在妇科癌症的放射治疗后。我们相信这种新的阴道支架将减少手术后 术后早期停用支架，降低医疗费用，改善临床 为整个北美的女孩和妇女取得的成果。

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.