I-Corps: Customer Discovery for a Neovaginal Stent

这个I-Corps项目更广泛的影响潜力可以被视为社会影响和医疗影响。性别肯定护理可以将自杀率从40%大幅降低到1.8%。自1966年以来，确认性别的阴道成形术（手术创建阴道腔）及其相关的术后护理基本保持不变。与阴道成形术相关的并发症可能严重到患者需要重复手术的程度。目前预防并发症的护理标准要求患者躺在清洁安全的环境中，完全放松骨盆底，并插入硬塑料扩张器30分钟。患者需要在前3个月每天做3次。这意味着患者在前三个月内扩张270超过135小时。这里开发的设备将扩张事件的数量从270减少到2。去年，全球有超过20，000名跨性别女性接受了这一手术，并且这一发病率正在以24%的速度增长。经过适度的修改，该设备将适用于顺性别女性治疗辐射引起的阴道狭窄，Meyer-Rokitansky-Kuster-Hauser综合征，经阴道隔和半阴道sept.This I-Corps项目进一步开发了一种医疗设备，旨在预防并发症，减少与阴道手术相关的依从性障碍。阴道支架由三个不同的组件组成：刚性可移除内部组件、半刚性支架组件和具有集成冲洗机制的外部硅胶组件。在手术过程中，将该装置插入新的阴道腔;在此阶段，最里面的组件膨胀，并在手术后的前五天内留在患者体内，然后取出。在术后的前90天内，每30天更换一次中间和外部组件，以继续阴道腔的扩张。由于该设备能够在不同的愈合阶段进行操作以满足患者的需求，因此该设备可以取代当前术后护理实践的所有方面。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact potential of this I-Corps project can be seen as a social impact as well as a healthcare impact. Gender affirming care is known to dramatically drop suicidality from 40% to 1.8%. Gender affirming vaginoplasty surgery (surgical creation of a vaginal canal), and its associated post-operative care, has remained largely unchanged since 1966. The complications associated with vaginoplasty can be severe to the point where the patient will require a repeat procedure. The current standard of care to prevent complications requires that the patient lays down in a clean and safe environment, completely relax their pelvic floor, and insert a hard plastic dilator for 30 minutes. Patients are required to do this 3 times a day for the first 3 months. This means that patients are dilating 270 for over 135 hours during the first three months. The device developed here would reduce the number of dilation events from 270 to 2. There were over 20,000 transgender women undergoing this procedure worldwide last year and this incidence is growing at a rate of 24%. With moderate modifications, this device would be appropriate for cis-gendered women to treat radiation-induced vaginal stenosis, Meyer-Rokitansky-Kuster-Hauser syndrome, transvaginal septum, and hemi-vaginal septum.This I-Corps project further develops a medical device designed to prevent complications and reduce compliance barriers associated with the surgical creation of a vagina. The vaginal stent is composed of three distinct components: the rigid removable inner component, the semi-rigid stent component, and the outer silicone component with integrated douching mechanism. The device is inserted into the new vaginal canal during the procedure; at this stage the innermost component is expanded and remains in the patient for the first five days postoperatively before removal. The middle and outer component are replaced every 30 days for the first 90 days postoperatively to continue the expansion of the vaginal canal. Because the device is able to be manipulated to match the needs of the patient through the different phases of healing, this device can replace all aspects of current practices of post-operative care.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.