The First Non-Surgical Anti-Stomal Prolapse Medical Device to Treat and Prevent Stomal Prolapse

摘要 肠造口，如回肠造口和结肠造口是肠道手术的开口 外置到腹部表面上以将肠内容物从远端癌，梗阻， 炎症和感染5.仅在美国，就有大约150万人有胃。脱垂或突出， 肠通过造口是一种常见的并发症，可导致疼痛，造口梗阻，肠 水肿、出血、大便渗漏和局部缺血12.吻合口脱垂的急性治疗采用手动复位， 床旁或全身麻醉下，但易于复发。在紧急情况下，如肠缺血， 脱垂可能需要手术干预以复位。吻合口脱垂的决定性治疗是 手术以修正造口并移除额外的肠10。 我们设计了一种新的装置，NoLapse，它可以非手术地防止造口脱垂。的 NoLapse有一个半柔性的硅胶环，放置在肠腔内，以抑制蠕动 运动随附的尺寸套件可帮助用户选择正确的尺寸。我们人类的紧急用途 病例、初步实验室和尸体动物研究已经证明了 这系统. 本STTR应用中的拟议研究旨在实现两个目标：1）推进设计 和NoLapse的开发，以及2）开始动物研究，以评估器械的安全性和有效性 in vivo.为了开发产品，我们将进行用户验证和台架测试，以选择材料， 制造方法和设计涉及的NoLapse。该产品包括NoLapse 器械及其测量套件将与ISO 13485硅胶制造商合作生产。测试 在体内的产品，我们将进行剖腹手术，在8头猪中建立回肠造口术，并记录脱垂事件。 实验组（n = 6）将在术后第1天插入NoLapse， 将手动减少对照组（n = 2）中发生的事件。该设备将在24小时后移除（2 猪）、1周（2头猪）或2周（2头猪）。在2周时间点处死猪后，我们将进行 尸检并评价组织病理学以评估压迫性坏死。在第1阶段STTR结束时 格兰特，我们将大大推进设备的设计和开发，完成动物研究，并达到 告知产品安全性和有效性的终点。在成功完成这项工作后，我们计划申请 用于通过人体临床试验和FDA监管进一步开发产品的2期STTR拨款 和分类准则。

ABSTRACT Intestinal stomas such as ileostomies and colostomies are openings of the intestinal tract surgically exteriorized onto the abdominal surface to divert enteric content away from distal cancer, obstruction, inflammation, and infection 5. In the US alone, about 1.5 million people have stomas14. Prolapse, or protrusion, of the bowel through the stoma is a common complication that can cause pain, stomal obstruction, bowel edema, bleeding, stool leakage, and ischemia 12. Stomal prolapse is treated acutely using manual reduction at the bedside or under general anesthesia but is prone to recur. In emergent cases, such as intestinal ischemia, a prolapse may require surgical intervention for reduction. The definitive treatment of stomal prolapse is an operation to revise the stoma and remove additional bowel 10. We have designed a novel device, the NoLapse, which prevents stomal prolapse non-operatively. The NoLapse has a semi-flexible silicone ring that is placed inside the intestinal lumen to dampen peristaltic movement. An accompanying sizing kit helps the user select the correct size. Our human emergency use case, preliminary benchtop, and cadaveric animal studies have demonstrated the efficacy and functionality of this system. The proposed research in this STTR application is designed to accomplish two goals: 1) advance the design and development of the NoLapse and 2) to begin animal studies to assess the safety and efficacy of the device in vivo. To develop the product, we will perform user validation and benchtop tests to select the materials, manufacturing methods, and designs involved in the NoLapse. The product, which includes the NoLapse device and its sizing kit, will be manufactured in collaboration with an ISO 13485 silicone manufacturer. To test the product in vivo, we will perform a laparotomy, create an ileostomy in 8 pigs, and record prolapse episodes. The NoLapse will be inserted on postoperative day 1 in the experimental group (n = 6), while any prolapses occurring in the control group (n = 2) will be manually reduced. The device will be removed after 24 hours (2 pigs), 1 week (2 pigs), or 2 weeks (2 pigs). After pigs are sacrificed at the 2-week time point, we will perform a necropsy and evaluate the histopathology to assess pressure necrosis. At the conclusion of the Phase 1 STTR grant, we will significantly advance the device’s design and development, complete animal studies, and reach the endpoints that inform product safety and efficacy. After successful completion of this work, we plan to apply for the Phase 2 STTR grant to further develop the product through human clinical trials and FDA regulatory and classification guidelines.