System for Image-Guided, Minimally-Invasive Kidney Surgery

描述（由申请人提供）：每年约有35，000名美国人被诊断患有肾细胞癌。该疾病每年导致约12，000名美国人死亡，并且在所有泌尿系统癌症中死亡率最高（约为前列腺癌和膀胱癌死亡率的两倍）。在过去，肾细胞癌的治疗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，则患者将面临发生肾功能不全或肾功能完全丧失的终身风险。幸运的是，最近成像技术的进步大大提高了对适合局部切除的小肿瘤的检测。因此，仅手术切除包含肿瘤的肾脏部分（肾部分切除术）已成为许多患者的首选方法。这种向侵略性较低的手术的过渡伴随着对微创腹腔镜手术的依赖增加。腹腔镜手术已成为许多医院的首选方法，因为患者的偏好（开放性肾脏手术需要疼痛的侧腹切口），住院时间更短，失血量减少，伤口感染风险更低。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难以使肿瘤边缘可视化并在解剖结构周围导航。因此，腹腔镜肾部分切除术的严重并发症（包括血管损伤和未能获得清晰的手术切缘）的发生率仍然高于可比的开放手术。该项目的目标是开发一种系统，使肾外科医生能够在腹腔镜下切除肾脏病变期间使用先前开发的图像引导神经外科手术方法。这些方法允许关键解剖结构的边缘（例如，肿瘤、血管和导管）叠加到腹腔镜视频图像上。第一阶段的项目将涉及一个原型系统的建设，并在实验室测试与肾脏体模的原型的性能评价。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。我们的团队还包括具有腹腔镜手术专业知识的杰出外科医生和生物医学工程师，他们是图像引导手术发展的先驱。公共卫生相关性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局的一种手段。腹腔镜肾部分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，这种腹腔镜手术的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.