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）：从手术角度来看，胰腺是最具挑战性的器官之一，目前尚无技术可在切除后有效密封该器官。胰漏和胰瘘的发展是胰腺切除术后发病率和死亡率的最重要原因，30-50%的术后患者发生腹腔脓毒症。麻醉和围手术期管理的改进将胰腺切除术的手术死亡率降低到5%以下，5不幸的是，术后发病率仍然很高，即使在大系列中也接近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分析了1996-2005年期间接受胰管切除术治疗导管腺癌的182例患者，得出的结论是，影响长期生存的主要因素是手术失血量。本申请的目的是测试在远端胰腺切除术后使用激光组织焊接（LTW）凝闭胰腺的首次人体可行性。LTW是一种激光-生物组合器械，采用非压缩、非消融技术立即接合和密封组织，以控制血液、胃肠液、尿液、胆汁、淋巴液和脑脊液的泄漏。当用于涉及创伤、癌症和存在凝血病或抗凝作用的移植的固体内脏器官（如肝脏、脾脏、胰腺和肾脏）的表面时，它可以挽救生命。具体目标1.使用激光组织焊接的部分近端和远端胰腺切除术：在18只猪中进行的12周GLP临床前安全性和有效性研究（时间：6个月）使用激光组织焊接的近端和远端胰腺部分切除术：安全性和有效性临床试验（时间：18个月）2.1.临床试验的试验用器械豁免（IDE）提交和批准，以及IRB批准。2.2.在10例患者中进行的用于远端胰腺切除术适应症的初步人体可行性临床研究。2.3.在10例患者中进行的胰肠吻合术适应症的初步人体可行性临床研究。潜在的技术创新：LTW开发了一种工艺和两种专有的生物可吸收人血白蛋白产品的组合，用于在胰腺、利耶和肾脏的手术修复过程中密封组织，以阻止血液、胆汁（碱性）、胰腺（蛋白水解）和尿液（酸性）等液体泄漏。4，6该组合器械具有激光精度和多功能性，可密封组织，而无需对正常或异常组织进行热消融。预期结果：将需要批准上市前市场批准（PMA）申请，以及每个解剖区域、器官和使用适应症的单独IDE申请。潜在的商业应用：LTW可用于密封和连接所有组织。应用包括实体内脏器官创伤和肿瘤切除术后的密封;劈离式肝移植;腹腔镜肾切除术;尿道修复术、尿道下裂修复术、硬脑膜密封、脊柱融合术和困难的牙科止血。