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

 描述(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，目前还没有技术可以在切除后有效地封闭这个器官。胰漏和胰瘘的发生是胰腺切除术后发病率和死亡率的最重要原因，腹部脓毒症的发生率为30-50%，占术后患者的1.5%。麻醉方法和围手术期处理的改进使胰腺十二指肠切除术的手术死亡率降至5%以下。5遗憾的是，术后并发症仍居高不下，即使大批量手术也接近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从长期来看，Kazankin等人分析了1996-2005年间182例接受胰腺十二指肠切除术治疗导管腺癌的患者，得出结论：影响长期生存的主要因素是手术失血。这项应用的目的是测试人类第一次使用激光组织焊接(LTW)在远端胰腺切除后封闭胰腺的可行性。LTW是一种激光-生物组合装置，它使用非压缩、非消融技术即时连接和封闭组织，以控制血液、胃肠道液体、尿液、胆汁、淋巴和脑脊液的泄漏。用于肝、脾、胰腺和肾脏等涉及创伤、癌症和存在凝血或抗凝情况下的移植的固体内脏器官的表面时，它是拯救生命的。具体目的1.应用激光组织焊接的胰腺近端和远端部分切除：18头猪12周的GLP临床前安全性和有效性研究(时间：6个月)2.使用激光组织焊接的胰腺近端和远端部分切除：安全性和有效性临床试验(时间：18个月)临床试验的研究设备豁免(IDE)提交和批准，以及IRB批准。2.2.先导人可行性临床研究10例患者行远端胰腺切除术的适应证。2.3.先导人为10例患者行胰肠吻合术的可行性临床研究潜在的技术创新：LTW已经开发出一种工艺和两种专有的可生物吸收的人体白蛋白产品的组合，这些产品应用于密封组织，以在胰腺、肝脏和肾脏的外科修复期间阻止液体泄漏，如血液、胆汁(碱性)、胰腺(蛋白分解)和尿液(酸性)。4、6这种组合设备具有激光精度，具有通用性，可以密封组织，而无需对正常或异常组织进行热消融。预期结果：将需要批准上市前批准(PMA)申请，每个解剖区域、器官和使用适应症都有单独的IDE申请。潜在商业应用：LTW可用于密封和连接所有组织。应用包括实体内脏器官损伤和肿瘤切除后的封闭；分裂肝移植；腹腔镜肾切除术；尿道修复、尿道下裂修复、硬膜封闭、脊柱融合和难以止血的牙齿。

 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.