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

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要/摘要：该提案的目标是创建一种新的机器人系统，能够切除膀胱肿瘤目前，它们被完全完整地移除，这会扩散癌细胞，并导致不健康。独家诊断和分期，这会大大增加患者的发病率和死亡率。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手臂，从而使灵巧且独立的组织操作、电外科解剖和可视化。临床意义来自于大量患有膀胱癌的患者——81,180 名新患者仅在美国每年就有如此多的诊断病例[12]——以及这些患者面临的高发病率和死亡率。每年有 17,000 人死于该疾病，并且 78% 的肿瘤会复发 [47]。目前需要将肿瘤逐一切除，而不是完整切除，这会导致阳性切缘、扩散癌细胞，并使病理评估高度不确定。我们的系统旨在使肿瘤成为可能。完整切除，无阳性切缘，并附有肌肉组织，这将能够准确、及时诊断，以及关键的、迫切需要的分期信息。使我们的系统如此之小的创新在于我们利用弯曲管的弹性相互作用制造出可以弯曲和伸长的微型灵巧手术器械。现有临床经尿道内窥镜的端口在其尖端提供触手般的灵活性。之所以具有创新性，是因为它提供了通过 8.6 毫米直径所需的灵活性和可视化。尿道，即当今临床使用的最小单端口机器人直径的 1/4。外科医生用两只手可以独立于内窥镜移动，我们将完整地切除膀胱这将降低阳性切缘率并提供带有肌肉的样本，从而使肿瘤更加准确。此外，我们的系统的机械和电子设备也大大减少。与目前的商用手术机器人相比，它的组件成本可以便宜大约 10 倍，同时仍然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交付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，在这个直接进入二期项目中，我们将我们的系统转化为临床产品并通过实验证明它提高了切除精度并有助于获得具有负切缘和肌肉的完整标本为了做到这一点，在目标 1 中，我们设计了一个 OR-ready 支持系统。并执行系统准确性的台式验证在目标 2 中，我们执行形成性和总结性人工验证。因素研究以确保系统的可用性和安全性在目标 3 中，我们通过实验验证系统。该第二阶段项目的终点将是一个准备就绪的系统。接受最终的 FDA 测试（例如生物相容性、无菌性、电磁干扰等），为最初人类临床使用。