I-Corps: Customer Discovery for a Neovaginal Stent

这个i-Corps项目的更广泛的影响潜力可以被视为社会影响以及医疗影响。众所周知，性别肯定护理可以大幅降低自杀率，从40%降至1.8%。自1966年以来，性别确认阴道成形术(手术创造阴道通道)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会很严重，以至于患者需要重复手术。目前预防并发症的护理标准要求患者躺在干净安全的环境中，完全放松盆底，并插入硬塑料扩张器30分钟。在最初的3个月里，患者被要求每天这样做3次。这意味着患者在头三个月里扩张270个小时超过135个小时。这里开发的设备将把扩张术的次数从270次减少到2次。去年，全球有超过2万名变性女性接受了这种手术，而且这一比例还在以24%的速度增长。经过适度的修改，这种设备将适合顺式性别的女性治疗放射诱导的阴道狭窄、Meyer-Rokitansky-Kuster-Hauser综合征、经阴道间隔和半阴道间隔。这个i-Corps项目进一步开发了一种医疗设备，旨在预防与手术创建阴道相关的并发症和减少顺应性障碍。该阴道支架由三个不同的部件组成：刚性可拆卸内部件、半刚性支架部件和具有集成冲洗机构的外部硅胶部件。在手术过程中，该装置被插入到新的阴道中；在这个阶段，最里面的部件被扩张，并在手术后的头五天内保留在患者体内，然后取出。术后前90天，每隔30天更换一次中、外假体，以继续扩张阴道。由于该设备能够在康复的不同阶段进行操作，以满足患者的需求，因此该设备可以取代当前手术后护理实践的方方面面。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.