System for Image-Guided, Minimally-Invasive Kidney Surgery

描述（由申请人提供）：每年大约有35000名美国人被诊断为肾细胞癌。这种疾病每年导致大约12000名美国人死亡，是所有泌尿系统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，治疗肾细胞癌需要手术切除整个受影响的肾脏，如果患者的剩余肾脏因任何原因受损，则患者终生面临肾功能不全或肾功能完全丧失的风险。幸运的是，近年来影像学的进步极大地提高了对适于局部切除的小肿瘤的检测。因此，手术切除含有肿瘤的那部分肾脏（部分肾切除术）已成为许多患者的首选方法。这种向微创手术的转变伴随着对微创腹腔镜手术的依赖。由于患者的偏好（开腹肾手术需要疼痛的腹部切口）、更短的住院时间、更少的失血和更低的伤口感染风险，腹腔镜手术已成为许多医院的首选方法。然而，腹腔镜肾脏手术在技术上要求很高，主要是由于目前的腹腔镜工具在观察肿瘤边缘和在解剖结构周围导航方面存在困难。因此，腹腔镜部分肾切除术的严重并发症（包括血管损伤和无法获得清晰的手术边缘）的发生率仍然高于类似的开放式手术。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肾脏病变切除术中使用先前为图像引导神经外科手术开发的方法。这些方法允许将关键解剖结构（如肿瘤、血管和导管）的边缘叠加到腹腔镜视频图像上。第一阶段的项目将包括建造一个原型系统，并在实验室测试中用肾脏模型评估原型的性能。我们为这个项目组建了一支高素质的团队。Creare的首席工程师在腹腔镜技术的开发和新型医学成像技术的开发方面具有丰富的经验。我们的团队还包括在腹腔镜手术方面具有专业知识的杰出外科医生，以及在图像引导手术发展方面处于领先地位的生物医学工程师。该项目的目标是开发一种新技术，以辅助手术导航，作为降低并发症发生率和改善腹腔镜肾脏手术结果的一种手段。腹腔镜部分肾切除术是一种常见的手术，为患者提供了巨大的好处。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放手术。

DESCRIPTION (provided by applicant): Approximately 35,000 Americans are diagnosed with renal cell carcinoma each year. The disease kills about 12,000 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. Laparoscopic surgery has become the preferred approach at many hospitals due to patient preference (open kidney surgery requires a painful flank incision), shorter hospital stays, reduced blood loss, and lower risk of wound infection. 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. The Phase I project will involve construction of a prototype system, and evaluation of the performance of the prototype in laboratory tests with a kidney phantom. 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.