A Robotic System to Remove Bladder Tumors Intact: The Key to Making Lifesaving Treatment Decisions

完整切除膀胱肿瘤的机器人系统：做出救生治疗决策的关键

• 批准号: 10760853
• 负责人: Richard Joseph Hendrick
• 金额: $ 91.4万
• 依托单位: VIRTUOSO SURGICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-09 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10760853
• 关键词: Animals; Bladder; Bladder Neoplasm; Cadaver; Cauterize; Clinical; Compensation; Curved Tube; Diagnosis; Diameter; Disease; Dissection; Elasticity; Electromagnetics; Electronics; Electrosurgery; Endoscopes; Endoscopic Surgical Procedures; Ensure; Evaluation; Excision; Face; Force of Gravity; Goals; Hand; Hemorrhage; Human; Invaded; Life; Localized Disease; Malignant neoplasm of urinary bladder; Mechanics; Morbidity - disease rate; Motion; Motor; Movement; Mucous Membrane; Muscle; Needles; Newly Diagnosed; Operative Surgical Procedures; Pathologic; Patients; Performance; Persons; Phase; Preparation; Primary Neoplasm; Process; Recurrence; Recurrent tumor; Resected; Robot; Robotics; Rotation; Safety; Salvelinus; Sampling; Specimen; Staging; State of Zero Gravity; Sterility; Stream; Support System; Surgeon; Surgical Instruments; System; Testing; Time; Tissues; Tube; Urethra; Validation; Visualization; aggressive therapy; arm; biomaterial compatibility; cancer cell; chemotherapy; clinically significant; commercialization; design; dexterity; experience; experimental study; improved; innovation; instrument; instrumentation; mortality; nitinol; public health relevance; robot control; robotic system; tool; tumor; usability

Project Summary/Abstract: The objective of this proposal is to create a new robotic system that enables bladder tumors to be removed completely and intact. Currently they are removed piecemeal, which spreads cancer cells, and results in incon- clusive diagnosis and staging, which dramatically increases morbidity and mortality for patients. Our system will deliver two needle-sized, tentacle-like arms through the port of a standard transurethral endoscope, enabling dexterous and independent tissue manipulation, electrosurgical dissection, and visualization. Clinical significance comes from the large number of patients who experience bladder cancer – 81,180 new diagnoses per year in the USA alone [12] – as well as the high morbidity and mortality these patients face. 17,000 people die each year from the disease and tumors recur 78% of the time [47]. This is believed to be due to the current need to remove the tumor piecemeal, rather than intact, which results in positive margins, spreads cancer cells, and makes pathological assessment highly uncertain. Our system aims to enable tumors to be removed intact, with no positive margins, and with muscle tissue attached, which will enable accurate, timely diagnosis, with critical, urgently needed staging information. The Innovation that enables our system to be so small is that we harness elastic interactions of curved tubes to create miniature, dexterous surgical instruments that can bend and elongate. These instruments pass through the port in an existing clinical transurethral endoscope to provide tentacle-like dexterity at its tip. Our system is innovative because it provides dexterity and visualization at the 8.6mm diameter needed to pass through the urethra, i.e. 1/4 the diameter of the smallest single port robots used clinically today. We hypothesize that providing the surgeon with two hands that can move independently of the endoscope we will make intact removal of bladder tumors more accurate. This will reduce positive margin rates and provide samples with muscle attached, which is known to facilitate accurate staging. Also, because our system has dramatically fewer mechanical and electronic components than current commercial surgical robots, it can be made approximately 10 times less expensive, while still providing a healthy revenue stream and profit margin for our company. Approach In our Phase I equivalent preliminary studies, we demonstrated that concentric tubes can be delivered through an endoscope and controlled robotically by a surgeon. Leveraging these exciting preliminary studies, in this direct to Phase II project, we convert our system into a clinical product and experimentally demonstrate that it improves resection accuracy and facilitates obtaining intact specimens with negative margins and muscle attached, in realistic phantom and cadaver studies. To do this, in Aim 1, we design an OR-ready support system and perform benchtop verification of system accuracy. In Aim 2 we perform both formative and summative human factors studies to ensure the usability and safety of the system. In Aim 3 we validate the system experimentally in anthropomorphic phantoms and cadavers. The endpoint of this Phase II project will be a system that is ready to undergo final FDA testing (e.g. biocompatibility, sterility, electromagnetic interference, etc.), in preparation for initial human clinical use.

项目概要/摘要： 该提案的目的是创建一个新的机器人系统，使膀胱肿瘤被删除 完整无损目前，它们被逐块切除，这会扩散癌细胞，导致癌症。 诊断和分期的复杂性，这大大增加了患者的发病率和死亡率。我们的系统会 通过标准经尿道内窥镜的端口输送两个针头大小的触手状臂，从而实现 灵巧和独立的组织操作、电外科切割和可视化。 临床意义来自于大量的患者谁经历膀胱癌- 81,180新 仅在美国，每年的诊断[12] -以及这些患者面临的高发病率和死亡率。 每年有17，000人死于这种疾病，78%的时间肿瘤复发[47]。这被认为是由于 到目前需要切除肿瘤零碎，而不是完整的，这导致积极的边缘，扩散 癌细胞，并且使得病理评估高度不确定。我们的系统旨在使肿瘤 完整地移除，没有阳性边缘，并且附着有肌肉组织，这将使准确，及时 诊断，关键的，迫切需要的分期信息。 使我们的系统如此之小的创新是，我们利用弯曲管道的弹性相互作用， 制造出微型的、灵巧的、可以弯曲和伸长的手术器械。这些仪器通过 现有的临床经尿道内窥镜中的端口，以在其尖端提供类似触手的灵活性。我们的系统 是创新的，因为它提供了灵活性和可视化，在8.6毫米直径需要通过 尿道，即目前临床上使用的最小单端口机器人直径的1/4。我们假设， 外科医生的双手可以独立于内窥镜移动，我们将完整地切除膀胱 肿瘤更准确。这将降低阳性边缘率，并提供附着肌肉的样本， 以便于准确的分期。此外，由于我们的系统具有更少的机械和电子 与目前的商业手术机器人相比，它可以便宜大约10倍， 同时还能为我们公司提供健康的收入来源和利润率。 方法在我们的第一阶段等效初步研究中，我们证明了同心管可以输送 通过内窥镜并由外科医生机器人控制。利用这些令人兴奋的初步研究， 在这个直接进入第二阶段项目中，我们将我们系统转化为临床产品，并通过实验证明 它提高了切除的准确性，有利于获得边缘和肌肉阴性的完整标本 附在真实体模和尸体研究中。为此，在目标1中，我们设计了一个OR就绪支持系统 并对系统精度进行实验室验证。在目标2中，我们执行形成性和总结性的人类 因素研究，以确保系统的可用性和安全性。在目标3中，我们通过实验验证了该系统 在拟人化的幻影和尸体中。第二阶段项目的终点将是一个准备就绪的系统 接受最终FDA测试（例如生物相容性、无菌性、电磁干扰等），为筹备 最初的人类临床应用。