Resorbable, Shape Memory Stents to Prevent Vaginal Fibrosis

可吸收形状记忆支架预防阴道纤维化 每年有近5万名女性青少年患者接受阴道重建术，大约 这些患者中有73%会在手术后患上衰弱的阴道纤维化。儿科和青少年 妇科医生通常在术后即刻使用阴道支架，以促进伤口愈合。 不幸的是，市场上唯一可用的阴道支架是大型的、非人体工程学的设计，这些设计很差。 在儿科人群中是耐受的。事实上，这些支架是在最近才重新开始使用的 停产5年以上。因此，许多外科医生求助于临时调班的设备 在手术室里创造出来的。所有这些选项都带来了部署挑战、规模调整选项有限以及 保持性差，经常需要缝合阴道以防止外泄。迫切需要一种 新型儿童/青少年专用阴道支架，具有适当的大小，可以对 新阴道的边界，以防止纤维化，并在伤口愈合期间保持阴道口径。钥匙 设计特点将包括通过改进的人体工程学轻松插入，防止Valsalva外泄，以及 最终预防纤维化，改善阴道愈合。此外，开发新的可再生材料 阴道支架将提供额外的优势，因为它消除了术后取出支架的需要 磨损时间结束了。在可吸收阴道支架的设计中，需要平衡机械 使支架保持阴道通畅性(例如，足够的径向强度)，同时避免不良反应的特性 生物反应，如组织过度生长，并确保足够的灵活性，使患者舒适。我们的 目的是设计一种可吸收的、形状记忆的阴道支架，以提高临床疗效和质量 儿童和青少年阴道手术后的生活质量。我们建议的设计利用了一种形状- 可生物降解的记忆泡沫，可呈现二次压缩形状，便于部署。 在插入时，温度和水合作用的变化将启动泡沫的膨胀，使其形状适合 个别患者并修复支架的管腔，以允许阴道分泌物排出。独一无二的是，这 避免了需要外部气囊来给支架充气，这是目前设计中常见的一种策略， 在临床部署过程中带来挑战。除了可调聚合物化学，多孔性 架构允许使用多种方法来优化机械性能、形状恢复和再吸收 运动学。在拟议的研究中，我们将制造和测试这种新的阴道支架的部署和保持 在台式模型中进行设计，然后在兔子模型中进行评估。儿童阴道支架早就该做了 这项研究在设计上是独一无二的，以满足这一服务不足的人群的需求。这种多功能的设计可以 也可为妇科和结直肠癌放疗后阴道狭窄的成人患者量身定做 治疗。

RESORBABLE, SHAPE MEMORY STENTS TO PREVENT VAGINAL FIBROSIS Nearly 50,000 female adolescent patients undergo vaginal reconstruction each year, and approximately 73% of these patients will suffer from debilitating vaginal fibrosis following surgery. Pediatric and adolescent gynecologic surgeons often use vaginal stents in the immediate postoperative setting to facilitate wound healing. Unfortunately, the only available vaginal stents on the market are large, non-ergonomic designs that are poorly tolerated in the pediatric population. Indeed, these stents only recently became available again after being removed from production for more than 5 years. As a result, many surgeons have resorted to make-shift devices created in the operating room. All of these options present deployment challenges, limited sizing options, and poor retention, which frequently requires suturing of the vagina to prevent egress. There is a critical need for a new pediatric/adolescent-specific vaginal stent with appropriate sizing that can apply constant pressure to the boundaries of the neovagina to prevent fibrosis and maintain vaginal caliber during wound healing. Key design features will include easy insertion with improved ergonomics, prevention of egress with Valsalva, and ultimately prevention of fibrosis and improved vaginal healing. In addition, the development of new resorbable vaginal stents would offer additional advantages by eliminating the need for postoperative stent removal after wear-time is complete. In the design of a resorbable vaginal stent, it is necessary to balance mechanical properties such that the stent maintains vaginal patency (e.g., sufficient radial strength) while avoiding adverse biological responses, such as tissue overgrowth, and ensuring sufficient flexibility for patient comfort. Our objective is to design a resorbable, shape-memory vaginal stent that can improve clinical outcomes and quality of life for pediatric and adolescent patients following vaginal surgery. Our proposed design utilizes a shape- memory foam that is biodegradable and can assume a secondary, compressed shape for ease of deployment. Upon insertion, the change in temperature and hydration will initiate the expansion of the foam to shape fit to the individual patient and restore the lumen of the stent to allow egress of vaginal secretions. Uniquely, this circumvents the need for an external balloon to inflate the stent, a strategy common to current designs that causes challenges during clinical deployment. In addition to the tunable polymer chemistry, the porous architecture allows for multiple methods to optimize the mechanical properties, shape recovery, and resorption kinetics. In the proposed studies, we will fabricate and test the deployment and retention of this newvaginal stent design in a benchtop model followed by assessment in a rabbit model. A pediatric vaginal stent is long overdue and this study is unique in its design to meet the needs of this underserved population. This versatile design can also be tailored for adult patients with post radiation vaginal stenosis due to gynecologic and colorectal cancer treatment.