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（由适用提供）：从外科手术角度来看，胰腺是最挑战的器官之一，没有可用的技术可以在切除后有效地密封该器官。胰腺泄漏和瘘管的发展是胰腺切除术和腹部败血症后发病和死亡率的唯一重要原因，发生在30-50％1，术后5例中。胰十二指肠切除术的麻醉和周期性治疗的改善5％，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％。对于接受胰腺远端脱糖切除术的患者，术后术后发生了胰腺瘘。7在长期的Kazanjian等人6中进行了分析，从1996 - 2005年进行了182例患者，他们从1996 - 2005年进行了胰腺二杜杜二肾上切除术，以治疗导管性腺癌的治疗损失，该损失是较长时间的损失。该应用的目的是测试使用激光组织焊接（LTW）在胰岛切除术后密封胰腺的第一个可行性。 LTW是一种激光生物结合装置，它使用非压缩的非燃料技术来立即连接和密封定时，以控制血液，胃肠道液体，尿液，胆汁，淋巴和脑脊液的泄漏。当在凝血病或抗凝存在的情况下，在肝散发器，胰腺和肾脏等固体内脏器官的表面上使用时，它会挽救生命。具体目的1。使用激光组织焊接的部分近端和远端胰腺切除术：十二周的GLP临床前安全性和在18头猪（时间：6个月）中的有效研究2。使用激光组织焊接局部近端和远端胰腺切除术：安全性和效率临床试验：安全性和效率临床试验（时间：18个月：18个月：18个月：18个月）2.1。调查设备豁免（IDE）提交和批准临床试验以及IRB批准。 2.2。在10例患者中，针对使用胰腺胰腺造口术指示的10例患者的PILOT人类可行性临床研究。潜在的技术创新：LTW已开发了一个过程和两个专有生物吸附的人白蛋白产品，这些产品可用于密封组织，以阻止液体泄漏，例如血液，胆汁（碱性），胰腺（蛋白水解）和尿液（酸性）和尿液（酸性），并在pancreas的手术过程中使用了pancreas的手术，lieer.4 lieer.4，lieer.4没有正常组织或异常组织热消融的组织。抗后果：将需要在每个解剖区域，器官和使用指示的情况下批准在市场上批准（PMA）申请，并具有单独的IDE应用程序。潜在的商业应用：LTW可用于密封和连接所有组织。应用包括在固体内脏器官创伤和肿瘤切除术后密封；分裂肝移植；腹腔镜肾切除术；尿道修复，肌关腹修复，硬脑膜密封，脊柱融合和困难的牙齿止血。