Portable fiber laser for glaucoma surgery

描述（由申请人提供）：这个I期SBIR项目的目的是证明一种新的2.71微米光纤激光器在青光眼手术中的疗效。这种激光器在光谱中水具有很强的光吸收的区域提供辐射。由于激光器由柔性光纤组成，因此具有便携、可靠、传输方便等优点。这种激光提供了很少或没有结膜操作的巩膜切除术的潜力，通过缺乏结膜切口的腹内技术，或一个小的结膜切口腹外技术。光纤激光器为传统手术提供了进入手术困难区域的途径，而且这种激光手术通常在技术上比传统手术更简单。该激光器将在Spire制造，因为该波长区域的激光器尚未商用。在第一阶段，面包板激光器将被制造出来，并在波士顿新英格兰眼科中心使用人体尸体的眼睛进行临床前体外手术。巩膜切除术和激光小梁消融（LTA）手术将使用光纤激光器进行。脉冲宽度和功率水平将从巩膜切除阈值到阈值以上一个对数单位。对巩膜组织进行热损伤区范围的组织学检查。在第二阶段，将设计和制造便携式激光器，并使用兔子模型将激光巩膜切除术与传统小梁切除术进行比较。对流出设施的影响将通过尸体人眼的LTA来评估。这些程序已被选定为理想的候选人使用的2.71微米光纤激光器。二期的成功完成将使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。

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.