Manufacturing Process for Albumin-ICG Solder & Denatured Albumin Scaffold

描述（由申请人提供）：长期目标：Laser Tissue Welding，Inc.该公司的研究和产品开发集中在创新的无缝线激光组织焊接领域，使用可生物降解和生物相容的生物材料，在存在稀释性凝血病或治疗性抗凝的情况下，在涉及创伤、癌症和移植的肝脏、脾脏和肾脏等固体内脏器官表面进行连接、修复和止血。具体目标：为激光组织焊接（LTW）所需的两种生物材料“白蛋白-吲哚菁焊料”（AIS）和“变性白蛋白支架”（DAS）开发新的制造工艺。本项目将在原型基础上讨论制造过程及其确认、设计控制、生物相容性、伽马辐照灭菌确认、包装强度和完整性、出于监管目的的加速老化。研究设计和方法：开发和验证AIS和DAS生物材料的生产工艺，工艺可以扩大规模和自动化。（每种产品约400个样本）潜在技术创新：该技术的成功因素是开发了一种由生物相容性变性人血白蛋白制成的上级支撑结构，可进行激光焊接。预期成果：在成功的原型制造和验证后，我们将按照cGMP规范扩大制造工艺，并开始监管审批流程，以开始人体临床试验。潜在的商业应用：这些是肝、脾和肾的创伤修复（200，000例/年）;肝脏肿瘤：原发性肝癌（22，000/年）和转移性肝肿瘤（65，000/年）;劈离式肝移植（等待名单上的17，300名患者）;良性病变的部分肾切除术（500例/年）;尿道修复：尿道下裂、尿道狭窄、尿道憩室和尿道瘘（600例/年）和皮肤缝合（目前使用缝线的所有外科手术）相关性：1）由于LTW能够快速修复（分钟）并控制脾脏、肝脏和肾脏等器官表面出血，且热损伤最小，因此LTW将挽救生命。2)帮助保存和抢救器官，如肝，脾，肾在创伤病例。3)通过减少输血需求来保护血液。4)可在腹腔镜下用于肝脏和肾脏的择期手术。

DESCRIPTION (provided by applicant): Long term objectives: Laser Tissue Welding, Inc. focuses its research and product development in areas of innovative sutureless laser tissue welding using biodegradable and biocompatible biomaterials to join, repair and create hemostasis on surfaces of solid visceral organs such as the liver, spleen and kidney involved in trauma, cancer, and transplantation in the presence of dilutional coagulopathies or therapeutic anticoagulation. Specific Aims: Develop new manufacturing processes for 'Albumin-lndocyanine Solder' (AIS) and 'Denatured Albumin Scaffold' (DAS) two biomaterials required for laser tissue welding (LTW). This project will address the manufacturing process and its validation, design control, biocompatibility, gamma radiation sterilization validation, package strength and integrity, accelerated aging for regulatory purposes on a prototype basis. Research design and Methods: Develop and validate the manufacturing process for AIS and DAS biomaterials with processes that can be scaled up and automated. (Approximately 400 samples per product) Potential Technology innovation: The success factor for this technology is the development of a superior support structure made of biocompatible denatured human albumin that can be laser soldered. Anticipated outcomes: After successful prototype manufacturing and validation, we will scale up the manufacturing process to cGMP specifications and begin the regulatory approval process to begin human clinical trials. Potential commercial applications: These are trauma repair of the liver, spleen and kidney (200,000 case/year); liver tumors: primary hepatomas (22,000/yr), and rietastatic liver tumors (65,000/yr); split liver transplant (17,300 patients on the waiting list); partial nephrectomy for benign lesions (500/year); Urethral repair: for hypospadias, urethral stricture, urethral diverticulum, and urethral fistulae (600/yr) and skin approximation (all surgical procedures that currently use sutures) Relevance: 1) LTW will save lives due to its ability to quickly repair (minutes) and control hemorrhage from the surfaces of organs such as the spleen, liver, and kidney with minimal thermal injury. 2) Helps preserves and salvages organs such as liver, spleen, and kidney in trauma cases. 3) Blood conservation by reducing transfusion requirements. 4) Can be used laparoscopically for elective surgeries on liver and kidney.