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

第一个治疗和预防造口脱垂的非手术防造口脱垂医疗器械

基本信息

批准号：
10482616
负责人：
Folarin Erogbogbo
金额：
$ 25.66万
依托单位：
PEDIATRIC MEDICAL DEVICE COMPANY LLC
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-14 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10482616
关键词：
Abdomen Acute Address Adult Animals Autopsy Biomedical Engineering Cadaver Caliber Childhood Classification Clinical Clinical Trials Collaborations Colostomy Procedure Complication Consumption Control Groups Defect Development Device Designs Devices Disease Distal Edema Emergency Situation Emergency department visit Enteral Evaluation Extravasation Failure Family suidae Feces Feedback Freezing Funding Future General Anesthesia Goals Grant Guidelines Hemorrhage Histology Histopathology Hospitalization Hour Human Ileostomy Infant Infection Inflammation Inflammatory Intervention Intestinal Cancer Intestines Ischemia Ischemic Bowel Disease Label Laparotomy Lead Malignant Neoplasms Manuals Manufacturer Name Measures Medical Medical Care Costs Medical Device Medical Device Designs Methods Morbidity - disease rate Movement Necrosis Obstruction Operative Surgical Procedures Output Pain Pathway interactions Patient Care Patients Persons Phase Postoperative Period Prevention Process Production Ptosis Readiness Recurrence Research Risk Safety Silicones Skin Small Business Technology Transfer Research Specialist Splint Device Stomas Surface Surgeon Surgical sutures System Testing Time Validation Work abdominal wall cost design experimental group flexibility gastrointestinal system in vivo innovation novel operation pressure prevent prototype public health relevance quality assurance wasting

项目摘要

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.

抽象的肠造口，例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以转移肠内容物远离远端癌症、梗阻、炎症和感染 5. 仅在美国，就有约 150 万人患有造口脱垂或突出。肠道通过造口是一种常见的并发症，可导致疼痛、造口梗阻、肠道水肿、出血、大便渗漏和缺血 12. 造口脱垂可采用手法复位进行急性治疗床边或全身麻醉下进行，但在紧急情况下，例如肠道缺血，很容易复发。造口脱垂的最终治疗方法是手术干预。修正造口并切除额外肠道的手术 10. 我们设计了一种新型装置 NoLapse，可以非手术方式防止造口脱垂。 NoLapse 有一个半柔性硅胶环，放置在肠腔内以抑制蠕动随附的尺寸套件可帮助用户选择正确的尺寸。案例、初步台式和尸体动物研究已经证明了其功效和功能这个系统。 STTR 应用中提出的研究旨在实现两个目标：1) 推进设计 NoLapse 的开发和 2) 开始动物研究以评估该设备的安全性和有效性为了开发产品，我们将进行用户验证和台式测试来选择材料， NoLapse 产品中涉及的制造方法和设计，其中包括 NoLapse。设备及其尺寸调整套件将与 ISO 13485 硅胶制造商合作制造以进行测试。该产品在体内，我们将进行剖腹手术，对 8 头猪进行回肠造口术，并记录脱垂情况。实验组 (n = 6) 将在术后第 1 天插入 NoLapse，同时任何脱垂对照组 (n = 2) 中发生的情况将在 24 小时后手动减少 (2)。猪）、1 周（2 头猪）或 2 周（2 头猪）在 2 周时间点处死猪后，我们将进行一次检查。在第 1 阶段 STTR 结束时进行尸检并评估组织病理学以评估压力性坏死。拨款，我们将显着推进该设备的设计和开发，完成动物研究，并达到成功完成这项工作后，我们计划申请告知产品安全性和有效性的终点。获得第二阶段 STTR 资助，通过人体临床试验和 FDA 监管进一步开发该产品和分类指南。