Portable fiber laser for glaucoma surgery

用于青光眼手术的便携式光纤激光器

• 批准号: 6631339
• 负责人: KURT J LINDEN
• 金额: $ 12.45万
• 依托单位: SPIRE CORPORATION
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-15 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6631339
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; clinical research; evaluation /testing; glaucoma surgery; histology; human tissue; lasers; portable biomedical equipment; sclera; trabeculotomy

DESCRIPTION (provided by applicant): The objective of this Phase I SBIR program is to demonstrate the efficacy of a new, 2.71 micrometer fiber laser in glaucoma surgery. This laser provides radiation in a region of the spectrum where water has very strong optical absorption. It is portable, reliable, and facilitates simple delivery because the laser consists of a flexible fiber. This laser offers the potential for sclerectomy with little or no conjunctival manipulation through the lack of a conjunctival incision with the ab interno techniques, or a small conjunctival incision with the ab externo techniques. The fiber laser offers access to surgically difficult areas for conventional surgery, and such laser procedures are often technically simpler than conventional surgery. The laser will be fabricated at Spire because lasers in this wavelength region are not commercially available. During Phase I, a breadboard laser will be fabricated and used in pre-clinical, in vitro procedures using human cadaver eyes at the New England Eye Center in Boston. Sclerectomy and laser trabecular ablation (LTA) procedures will be carried out with the fiber laser. Pulse widths and power levels will be bracketed from sclerectomy threshold to one log unit above threshold. Scleral tissue will be examined histologically for thermal damage zone extent. In Phase II a portable version of the laser will be designed and fabricated, and a comparison will be made between laser sclerectomy and conventional trabeculectomy, using rabbit models. Effects on outflow facility will be evaluated using LTA in cadaver human eyes. These procedures have been selected as ideal candidates for use with the 2.71 micrometer fiber laser. Successful completion of Phase II will enable Spire to manufacture a portable 2.71 micrometer fiber laser for use in a variety of medical applications.

描述（由申请人提供）：本I期SBIR项目的目的是证明新型2.71微米光纤激光器在青光眼手术中的疗效。该激光器提供光谱区域中的辐射，其中水具有非常强的光学吸收。它是便携式的，可靠的，便于简单的交付，因为激光器由柔性光纤组成。该激光器提供了巩膜切除术的可能性，通过使用ab interno技术缺少结膜切口或使用ab externo技术进行小结膜切口，很少或不进行结膜操作。光纤激光器为传统手术提供了手术困难区域的入口，并且这种激光手术在技术上通常比传统手术简单。该激光器将在Spire制造，因为该波长区域的激光器尚未上市。在第一阶段，将在波士顿的新英格兰眼科中心制造实验板激光器，并将其用于临床前的体外手术中。将使用光纤激光进行巩膜切除术和激光小梁消融术（LTA）。脉冲宽度和功率水平将从巩膜切除术阈值到高于阈值的一个对数单位。将对巩膜组织进行组织学检查，以确定热损伤区范围。在第二阶段，将设计和制造一种便携式激光器，并使用兔模型对激光巩膜切除术和传统小梁切除术进行比较。将在尸体人眼中使用LTA评价对流出道功能的影响。这些程序已被选为与2.71微米光纤激光器一起使用的理想候选程序。第二阶段的成功完成将使Spire能够制造用于各种医疗应用的便携式2.71微米光纤激光器。