LASER TISSUE WELDING: BREACHING BARRIERS IN THE SURGICAL MANAGEMENT OF THE PANCREAS

激光组织焊接：突破胰腺手术治疗的障碍

• 批准号: 9263921
• 负责人: Omar Barakat
• 金额: $ 50万
• 依托单位: LASER TISSUE WELDING, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-18 至 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9263921
• 关键词: Abdomen; Abdominal Abscess; Acids; Address; Adenocarcinoma; Aftercare; Albumins; Anatomy; Anesthesia procedures; Animals; Anticoagulants; Anticoagulation; Bile fluid; Biocompatible Materials; Biological Preservation; Blood; Blood Coagulation Disorders; Body Weight; Body of pancreas; Cerebrospinal Fluid; Cessation of life; Chemicals; Clinical; Clinical Pathology; Clinical Research; Clinical Trials; Coagulation Process; Collection; Control Groups; Cryosurgery; Defect; Dental; Dentistry; Device Safety; Devices; Disease; Distal; Domestic Pig; Duct (organ) structure; Ductal; Electrolytes; Enteral; Environment; Evaluation; Excision; Extravasation; Family suidae; Female; Fistula; Goals; Government; Grant; Head; Health; Healthcare; Hemorrhage; Hemostatic function; Histopathology; Human; Hypospadias; In Vitro; Investigation; Kidney; Label; Lasers; Lesion; Life; Liquid substance; Liver; Lymph; Malabsorption Syndromes; Malignant Neoplasms; Mediating; Methods; Morbidity - disease rate; Necrosis; Nephrectomy; Normal tissue morphology; Operating Rooms; Operative Surgical Procedures; Organ; Orthopedics; Outcome; Pancreas; Pancreatectomy; Pancreatic Fistula; Pancreaticoduodenectomy; Pancreaticojejunostomy; Patients; Perioperative; Peritonitis; Persons; Phase; Plasticizers; Porifera; Postoperative Period; Process; Randomized; Resected; Resources; Robotics; Safety; Savings; Sepsis; Septicemia; Series; Small Business Innovation Research Grant; Solid; Spinal Fusion; Spleen; Sterility; Surface; Surgeon; Surgical Management; Surgical sutures; Tail; Technology; Testing; Therapeutic Effect; Thermal Ablation Therapy; Time; Tissues; Toxic effect; Transplantation; Trauma; Urethra; Urine; Urology; Visceral; Welding; Wound Infection; alkalinity; biomaterial compatibility; chronic pancreatitis; clinical efficacy; commercial application; craniofacial; efficacy study; follow-up; gastrointestinal; improved; in vivo; innovation; invention; liver repair; liver transplantation; male; minimally invasive; mortality; neurosurgery; novel; oncology; pancreas development; pancreatic neoplasm; preclinical safety; prevent; prototype; public health relevance; radiofrequency; repaired; safety study; scaffold; seal; secondary infection; standard of care; success; tissue welding; treatment group; treatment site; tumor

 DESCRIPTION (provided by applicant): The pancreas is one of the most challenging organs from a surgical perspective and there is no technology available that effectively seals this organ after resection. The development of pancreatic leakage and fistula is the single most significant cause of morbidity and mortality after pancreatectomy and abdominal sepsis occurs in 30-50% 1, 5 of the postoperative patients. Improvements in anesthesia and perioperative management decreased the surgical mortality to less than 5% for pancreatoduodenectomy,5 unfortunately, the postoperative morbidity remains high and approaches 50% even in large series. For patients undergoing distal pancreatectomy, pancreatic fistulas occurred post-operatively in 31% of patients.7 Over the long term Kazanjian et al 6 analyzed, 182 patients from 1996-2005 who underwent pancreatoduodenectomy to treat ductal adenocarcinoma, concluded that the principal factor influencing long-term survival was operative blood loss. The goal of this application is to test the first-in-human feasibility of sealing the pancreas after distal pancreatectomy using laser tissue welding (LTW). LTW is a laser-biologic combination device which uses a non-compressive, non-ablative technology to join and seal tissues instantly for controlling the leakage of blood, gastrointestinal fluids, urine, bile, lymph, and cerebrospinal fluid. It is life-saving when used on the surfaces of solid visceral organs, such as the liver spleen, pancreas and kidney, involved in trauma, cancer and transplantation in presence of coagulopathies or anticoagulation. Specific Aims 1. Partial proximal & distal pancreatectomy using laser tissue welding: Twelve week GLP preclinical safety and efficacy studies in 18 pigs (Time: 6 months) 2. Partial proximal & distal pancreatectomy using laser tissue welding: Safety and Efficacy Clinical Trial (Time: 18 months) 2.1. Investigational device exemption (IDE) submission and approval for clinical trials, and IRB approval. 2.2. Pilot human feasibility clinica study in 10 patients for distal pancreatectomy indication of use. 2.3. Pilot human feasibility clinical study in 10 patients for pancreaticojejunostomy indication of use. Potential Technology innovation: LTW has developed a combination of a process and two proprietary bioabsorbable human albumin products that are applied to seal tissues to stop fluid leaks such as blood, bile (alkaline), pancreatic (proteolytic) and urine (acidic), during surgical repair of the pancreas, lier and kidney.4, 6 This combination device has laser precision with the versatility to seal tissues without thermal ablation of normal or abnormal tissues. Anticipated Outcomes: Would require the approval of a pre-market market approval (PMA) application with separate IDE applications for each anatomical region, organ and indication of use. Potential commercial applications: LTW may be used to sealing and joining all tissues. Applications include sealing after solid visceral organ trauma and tumor resections; split liver transplants; laparoscopic nephrectomy; urethral repair, hypospadias repair, dural sealing, spinal fusion and difficult dental hemostasis.

 描述（由申请人提供）：从外科角度来看，胰腺是最具挑战性的器官之一，并且没有可用的技术可以在切除后有效密封该器官。胰漏和瘘管的发展是发病和死亡的最重要原因。胰腺切除术后死亡率为 30-50% 1, 5 麻醉和围手术期管理的改进将手术死亡率降至 5% 以下。胰十二指肠切除术，5 不幸的是，术后发病率仍然很高，即使在大型系列中也接近 50%，对于接受远端胰腺切除术的患者，31% 的患者术后发生胰瘘。7 Kazanjian 等人 6 对 182 名患者进行了长期分析。 1996年至2005年接受胰十二指肠切除术治疗导管腺癌的患者得出的结论是，影响长期治疗的主要因素该应用的目的是测试使用激光组织焊接 (LTW) 进行远端胰腺切除术后密封胰腺的首次人体可行性，LTW 是一种使用非压缩性的激光生物组合装置。 ，非烧蚀技术立即连接和密封组织，以控制血液、胃肠液、尿液、胆汁、淋巴液和脑脊液的渗漏，用于挽救生命。实体内脏器官的表面，如肝脾、胰腺和肾脏，涉及创伤、癌症和移植，存在凝血病或抗凝具体目标 1. 使用组织激光焊接进行部分近端和远端胰腺切除术：12 周 GLP 临床前安全性。 18头猪的疗效研究（时间：6个月） 2. 激光近端和远端部分胰腺切除术组织焊接：安全性和有效性临床试验（时间：18 个月） 2.1. 临床试验研究设备豁免（IDE）提交和批准，以及 IRB 批准 2.2. 在 10 名患者中进行远端胰腺切除术适应症的试点人体临床研究。 2.3. 在 10 名患者中进行胰空肠吻合术使用适应症的试点人体临床研究 潜在技术创新：LTW 开发了一种工艺和两种专有技术的组合。生物可吸收的人白蛋白产品，在胰腺、内脏和肾脏的手术修复过程中，用于密封组织以阻止血液、胆汁（碱性）、胰腺（蛋白水解）和尿液（酸性）等液体渗漏。4, 6 这种组合装置具有激光精度和多功能性，可以在不热消融正常或异常组织的情况下密封组织。 预期结果：需要单独批准上市前市场批准 (PMA) 申请。适用于各个解剖区域、器官和潜在商业应用：LTW 可用于密封和连接所有组织，包括实体内脏器官损伤和肿瘤切除术后的密封；腹腔镜肾切除术；尿道下裂修复、硬脑膜封闭、脊柱融合和困难的牙齿止血。