System for Image-Guided, Minimally-Invasive Kidney Surgery

描述(由申请人提供)：每年约有54,000名美国人被诊断出患有肾癌。这种疾病每年导致大约14,000名美国人死亡，是所有泌尿系癌症中死亡率最高的(大约是前列腺癌和膀胱癌死亡率的两倍)。在过去，治疗肾癌需要手术切除整个受影响的肾脏，如果患者剩余的肾脏因任何原因受损，患者将面临发生肾功能不全或完全丧失肾功能的终身风险。幸运的是，最近成像技术的进步极大地提高了对可局部切除的小肿瘤的检测。因此，外科手术仅切除含有肿瘤的那部分肾脏(部分肾切除)已成为许多患者的首选方法。这种向低侵袭性手术的过渡伴随着对微创腹腔镜手术越来越多的依赖。然而，腹腔镜肾脏手术在技术上要求很高，主要是因为在可视化肿瘤边缘和导航解剖结构方面存在困难，这些都是目前的腹腔镜工具造成的。因此，严重并发症的发生率(包括血管损伤和未能获得明确的手术切缘)在腹腔镜肾部分切除术中仍然高于类似的开腹手术。该项目的目标是开发一种系统，使肾脏外科医生能够在腹腔镜下切除肾脏病变时使用以前开发的图像引导神经外科手术方法。这些方法允许将关键解剖结构(例如，肿瘤、血管和导管)的边缘叠加到腹腔镜视频图像上。在第一阶段，我们建造了一台能够在手术中测量肾包膜位置和形状的腹腔镜仪器。在第二阶段，我们将建立第二代精炼系统，并将在一系列动物实验中评估该系统的性能。我们已经为这个项目组建了一支非常合格的团队。Creare的首席工程师在开发腹腔镜技术和开发新的医学成像技术方面拥有丰富的经验。我们的团队还包括在腹腔镜手术方面具有专业知识的知名外科医生，以及一直是图像引导手术发展的先驱的生物医学工程师。 公共卫生相关性：该项目的目标是开发一种新的技术来辅助手术导航，作为一种降低并发症发生率和改善腹腔镜肾脏手术结果的手段。腹腔镜肾部分切除术是一种常见的手术方式，给患者带来了巨大的好处。不幸的是，这种腹腔镜手术发生严重并发症的风险仍然高于传统的开腹手术。

DESCRIPTION (provided by applicant): Approximately 54,000 Americans are diagnosed with renal cell carcinoma each year. The disease kills about 14,000 Americans each year and has the highest mortality rate of all urologic cancers (about twice the mortality rate of prostate and bladder cancer). In the past, treatment of renal cell carcinoma required surgical removal of the entire affected kidney leaving the patient at life-long risk for developing renal insufficiency or complete loss of renal function if their remaining kidney was compromised for any reason. Fortunately, recent advances in imaging have dramatically increased detection of small tumors that are amenable to local resection. As a result, surgical resection of only that portion of the kidney containing the tumor (partial nephrectomy) has become the preferred approach in many patients. This transition to less aggressive surgery has been accompanied by increased reliance on minimally-invasive, laparoscopic surgery. However, laparoscopic kidney surgery is technically demanding, primarily due to difficulties in visualizing tumor margins and navigating around anatomic structures imposed by current laparoscopic tools. As a result, the rate of significant complications (including vascular injuries and failure to obtain clear surgical margins) remains higher in laparoscopic partial nephrectomy than in comparable open procedures. The goal of this project is development of a system enabling renal surgeons to use methods previously developed for image-guided neurosurgery during laparoscopic resection of kidney lesions. These methods allow the margins of key anatomic structures (e.g., tumors, vessels, and ducts) to be superimposed onto the laparoscopic video images. During Phase I, we built a laparoscopic instrument capable of measuring the position and shape of the renal capsule during surgery. During Phase II, we will build a second-generation refined system and will evaluate the performance of the system in a series of animal experiments. We have assembled a highly qualified team for this project. The lead Creare engineers have experience in the development of laparoscopic technology and development of novel medical imaging technology. Our team also includes prominent surgeons with expertise in laparoscopic surgery, and biomedical engineers who have been pioneers in the development of image-guided surgery. PUBLIC HEALTH RELEVANCE: The goal of this project is development of a new technology to assist surgical navigation as a means of reducing complication rates and improving the outcomes of laparoscopic kidney surgery. Laparoscopic partial nephrectomy is a commonly performed procedure that offers tremendous benefits to the patient. Unfortunately, the risk of serious complications in this laparoscopic procedure remains higher than in conventional open surgery.