Laser-Activated Collagen Adhesives for Herniorrhaphy

用于疝修补术的激光激活胶原粘合剂

• 批准号: 6880582
• 负责人: BARBARA Ann SOLTZ
• 金额: $ 29.1万
• 依托单位: CONVERSION ENERGY ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6880582
• 关键词: bioengineering /biomedical engineering; biological models; biomedical equipment development; collagen; gastrointestinal surgery; hernia; laboratory rabbit; laparoscopy; lasers; medical complication; method development; model design /development; scars; surgical wound; swine; technology /technique development; tissue engineering; wound healing

DESCRIPTION (provided by applicant): One million herniorrhaphies are performed annually in the US, most incorporating mesh reinforcement particularly for incisional and inguinal hernia. Yet this procedure usually results in prolonged and painful convalescence with recurrent complications such as inflammation and adhesion formation. In fact, adhesions represent a significant source of morbidity and mortality and are a common cause of small bowel obstruction in previously operated patients. Laparoscopic approaches have been developed to eliminate some of these problems but clinical acceptance has been hampered by the complex nature of the surgery requiring a high level of surgeon skill. Laser-assisted tissue welding using a derivatized collagen solder may avoid compression or tissue injury that frequently occurs with mechanical mesh fixation, inhibit adhesion formation, beneficial in minimizing postoperative pain due to tissue ischemia and nerve entrapment syndromes and is inherently compliant with laparoscopic formats. Phase I studies were conducted to evaluate a variety of solder and mesh configurations, tissue bonding strategies, comparison of acute tensile strength of bonded peritoneum and the assessment of mesh stability, tissue damage and the presence/type of adhesions in a six week chronic study. Secure mesh fixation was achieved with mesh/solder overlay but the embedded mesh configuration provided a simple means of anchoring mesh to tissue. The resultant mesh composites displayed a typical biological response with minimal adhesion formation and highlight the potential for use in laparoscopic herniorrhaphy, peritoneal closure, and reinforcement of anastomoses. Specific aims for Phase II are to develop and implement appropriate animal models for the optimization of laparoscopic herniorrhaphy. Task descriptions include preparation of sterile solder under stringent process controls, design and assembly of a compact preclinical laser system, optimization of a laser laparoscopic hand piece and solder introducer tool and conduct chronic animal studies using lapine and porcine subjects.

描述（由申请人提供）： 美国每年进行100万例疝修补术，大多数采用补片加固，尤其是切口疝和腹股沟疝。然而，这一过程通常会导致长期和痛苦的恢复与复发性并发症，如炎症和粘连形成。事实上，粘连是发病率和死亡率的重要来源，也是既往手术患者小肠梗阻的常见原因。腹腔镜方法已被开发，以消除这些问题中的一些，但临床接受已受到阻碍的复杂性质的手术，需要高水平的外科医生的技能。使用衍生胶原焊料的激光辅助组织焊接可以避免机械补片固定经常发生的压迫或组织损伤，抑制粘连形成，有利于最大限度地减少组织缺血和神经卡压综合征引起的术后疼痛，并且本质上符合腹腔镜格式。进行了I期研究，以评价各种焊料和补片配置、组织粘合策略、粘合腹膜的急性拉伸强度比较以及在6周慢性研究中评估补片稳定性、组织损伤和粘连的存在/类型。使用补片/焊料覆盖层实现了补片的牢固固定，但嵌入式补片配置提供了将补片锚定到组织上的简单方法。所得补片复合材料显示出典型的生物学反应，粘连形成最少，并突出了用于腹腔镜疝修补术、腹膜闭合和增强疝的潜力。第二阶段的具体目标是开发和实施适当的动物模型，以优化腹腔镜疝修补术。任务描述包括在严格的过程控制下制备无菌焊料、设计和组装紧凑型临床前激光系统、优化激光腹腔镜手柄和焊料导入器工具，以及使用兔和猪受试者进行慢性动物研究。