Miniature Laser Therapy Endoscope

描述（由申请人提供）：本提案的总体目标是开发一种具有集成激光治疗功能的超小型（直径350 μ m）内窥镜成像设备，用于体内显微外科手术。本提案的具体目标是开发一种安全有效治疗双胎输血综合征（TTTS）的器械。TTTS是单绒毛膜妊娠的并发症，在美国每年约有3000例妊娠。在TTTS中，胎盘动静脉畸形的血流失衡剥夺了供体双胞胎的血液，而受体双胞胎变得高血容量。如果不治疗，胎儿死亡率非常高，在一些研究中高达90%。在子宫内激光消融所有交通血管是治疗TTTS的有效方法。然而，目前用于引导该过程的胎儿镜检查技术不足以用于该应用。相对较大尺寸的手术胎儿镜（2-3 mm直径）导致不可接受的高并发症发生率，包括医源性早产胎膜早破和宫内胎儿死亡。不良围产期结局也很常见，部分原因是现代胎儿镜的图像质量差，导致许多解剖被错过。在本提案中，我们将通过开发一种更小的显微外科内窥镜来克服当前TTTS治疗设备的局限性，该内窥镜提供具有更好图像质量的更多信息图像。这一进步将通过一种称为光谱编码内窥镜（SEE）的新技术实现，该技术使用波分复用技术通过单根光纤获得高分辨率图像。我们的小组以前已经证明了内窥镜二维和三维视频率成像使用350微米直径，单色版本的这种设备在体内。在拟议的研究中，我们将扩展SEE系统和探头，以区分动脉和静脉胎盘血管的颜色，并将增加多普勒成像来量化血流。此外，我们将通过相同的探头进行治疗激光输送，而不会增加其尺寸。我们的装置的总直径将为350 μ m，小到足以通过羊膜穿刺针（22号）引入羊膜腔，这将使并发症发生率降低10倍。我们的SEE系统和探头的有效性和安全性将在10只妊娠母羊的研究中与市售的胎儿激光治疗系统进行比较。虽然拟议研究的直接重点是胎盘血管凝固，但这项新技术有望成为各种微创手术的平台技术，特别是那些探针尺寸至关重要的手术。在本提案中，我们将开发一种超微型（直径350 m）内窥镜成像设备，具有集成激光治疗功能，用于体内显微外科应用。本研究的具体目标是创建一种安全有效治疗双胞胎输血综合征（TTTS）的设备，TTTS是双胞胎妊娠的严重并发症，具有较高的胎儿死亡率。我们将通过推进一项新技术来实现我们的目标，该技术被称为光谱编码内窥镜（SEE），它使用波分复用技术通过单根光纤获得高分辨率图像。除了治疗TTTS外，该器械还可用于其他应用中的内镜引导治疗，其中超小型器械对组织入路和患者安全至关重要。

DESCRIPTION (provided by applicant): The overall goal of this proposal is to develop an ultraminiature (350 ¿m diameter) endoscopic imaging device with integrated laser therapy capabilities for microsurgical applications inside the body. The specific goal of this proposal is to develop a device for safe and effective treatment of twin-twin transfusion syndrome (TTTS). TTTS is a complication of monochorionic pregnancies that occurs in approximately 3000 pregnancies/year in the United States. In TTTS, an imbalance of blood flow across placental arteriovenous anastomoses deprives the donor twin of blood, while the recipient twin becomes hypervolemic. When left untreated, fetal mortality is very high, up to 90% in some studies. Laser ablation of all of the communicating vessels in utero is an effective treatment for TTTS. However, current fetoscopy technology used to guide this procedure is not adequate for this application. The relatively large size of operative fetoscopes (2-3 mm diameter) leads to unacceptably high complication rates, including iatrogenic preterm premature rupture of membranes and in utero fetal demise. Adverse perinatal outcomes are also common, due in part to the poor image quality of modern fetosocopes, which causes many anatomoses to be missed. In this proposal we will overcome the limitations of current TTTS therapy devices by developing a much smaller microsurgical endoscope that provides more informative images with better image quality. This advance will be enabled by a new technology, termed spectrally encoded endoscopy (SEE) that uses wavelength division multiplexing to obtain high-resolution images through a single optical fiber. Our group has previously demonstrated endoscopic two- and three-dimensional video-rate imaging using a 350 ¿m diameter, monochromatic version of this device in vivo. In the proposed research, we will extend the SEE system and probe for color differentiation of arterial and venous placental vessels and will add Doppler imaging to quantify blood flow. Additionally, we will incorporate therapeutic laser delivery through the same probe without increasing its size. The total diameter of our device will be 350 ¿m, small enough to be introduced into the amniotic cavity through an amniocentesis needle (22-gauge), which should provide a 10-fold reduction in complication rate. The effectiveness and safety of our SEE system and probe will be compared with that of commercially available fetal laser therapy systems in a study of 10 pregnant ewes. While the immediate focus of the proposed research is placental vascular coagulation, this new technology holds promise as a platform technology for a wide variety of minimally invasive procedures, especially those where probe size is critical. In this proposal, we will develop an ultraminiature (350 ¿m diameter) endoscopic imaging device with integrated laser therapy capabilities for microsurgical applications inside the body. The specific goal of this research is to create a device for safe and effective treatment of twin-twin transfusion syndrome (TTTS), a severe complication of twin pregnancies that carries a high fetal mortality rate. We will accomplish our aims by advancing a new technology, termed spectrally encoded endoscopy (SEE) that uses wavelength division multiplexing to obtain high-resolution images through a single optical fiber. In addition to treatment of TTTS, this device can be used for endoscopically-guided therapy in other applications where ultraminiature instrumentation is critical for tissue access and patient safety.