A Hand-Held Robot to Cure BPH

治疗良性前列腺增生症的手持式机器人

• 批准号: 9563350
• 负责人: Richard Joseph Hendrick
• 金额: $ 3万
• 依托单位: VIRTUOSO SURGICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-04 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9563350
• 关键词: Address; Adoption; Affect; Benign Prostatic Hypertrophy; Blood Transfusion; Cadaver; Caliber; Catheterization; Clinical; Complex; Computer Simulation; Computer software; Consultations; Couples; Data; Devices; Disease; Endoscopes; Excision; Fiber; Fiber Optics; Goals; Hand; Holmium; Homing; Hospitalization; Imagery; Laser Surgery; Lasers; Magnetism; Monitor; Nature; Needles; Neuroendoscopy; Operating Rooms; Operative Surgical Procedures; Optics; Outcome; Patient-Focused Outcomes; Patients; Performance; Phase; Positioning Attribute; Procedures; Prostate; Protocols documentation; Randomized Controlled Trials; Repeat Surgery; Research; Robot; Robotics; Safety; Small Business Innovation Research Grant; Software Design; Software Validation; Speed; Sterility; Surgeon; System; Testing; Time; Tissues; Torque; Training; Tube; Validation; Work; X-Ray Computed Tomography; arm; base; biomaterial compatibility; clinically significant; cost effective; design; design and construction; dexterity; experience; experimental study; grasp; improved; in vivo; innovation; instrument; instrumentation; men; prevent; prostate surgery; prototype; public health relevance; robot assistance; standard of care; success; tool

Project Summary/Abstract: The objective of this proposal is to transform a hand-held surgical robotic system for transurethral laser prostate surgery from a lab prototype into a commercial product. The system will feature needle-sized arms deployed through the endoscope port and will enable independent tissue manipulation, laser aiming, and visual- ization, making surgery more accurate and efficient. Clinical significance comes from (1) the large number of patients who could benefit (1 in 3 men will need surgery for an enlarged prostate (BPH); there are 300,000 surgeries per year in the USA – projected to double in the next 10 years), and (2) the fact that only 1.7% of these patients currently benefit from the holmium laser- based procedure we seek to facilitate. This is in spite of multiple randomized controlled trials demonstrating that it reduces reoperation rates from 9-18% to essentially zero, eliminates the need for blood transfusions, and reduces hospitalization time by 43% and catheterization time by 63%. The reason for the underdeployment of holmium laser surgery is clear: the procedure is challenging for surgeons to accomplish, due to the lack of dexterity in current endoscope-deployed instruments. Currently, the surgeon must use the tip of a rigid endoscope to do three things at once: aim a laser fiber, visualize the surgical field, and maneuver tissue into position for cutting. We hypothesize that the availability of dexterous needle-sized arms to aim the laser and retract tissue at the endoscope tip will make the procedure easier to perform, and thereby facilitate wider adoption of a procedure that is already known to improve patient outcomes. The innovation in this work is that this is the first-ever multi-arm hand-held surgical robotic system. Further- more, in contrast to current commercial surgical robotic systems, which are large, expensive, and complex, our system will be small, cost effective, and require no complex surgeon console or articulated manipulator system surrounding the patient. These benefits come from the ability to deliver needle-sized robotic arms through the port in a standard clinical endoscope. The arms are made of telescoping, curved, elastic tubes. By axially rotating and telescopically extending the tubes, our robot will provide the surgeon with two small “tentacle-like” manipulators at the tip of the endoscope. One carries the holmium laser fiber for cutting, and the other enables retraction. Our approach in Aim 1 is to design a robotic system that is suitable for regulatory approval, addressing sterility and manufacturability. In Aim 2 we implement safety systems as well as software-based reliability monitoring approaches. In Aim 3 we validate the system experimentally, quantitatively comparing surgeon performance with our robotic system to the current standard of care. The outcomes of this project are (1) an operating-room- ready robotic system, (2) an FDA pre-submission with complete regulatory master plan, and (3) quantitative data showing that our system makes surgeons who have not previously tried holmium laser surgery operate with speed and quality comparable to surgeons without the robot who have done 50+ cases (i.e. it eliminates the instrument dexterity barriers that currently prevent patients from benefiting from this procedure).

项目摘要/摘要： 该提案的目的是转换手持尿道激光的手持手术机器人系统 从实验室原型到商业产品的前列腺手术。该系统将具有针大小的武器 通过内窥镜端口部署，将实现独立的组织操纵，激光目标和视觉 Ization，使手术更加准确和有效。 临床意义来自（1）大量可能受益的患者（三分之一的男人需要 前列腺扩大（BPH）的手术；美国每年有300,000次手术 - 预计将两倍 在接下来的10年中），以及（2）目前只有1.7％的患者受益于Holmium Laser- 我们寻求促进的基于程序。尽管有多次随机对照试验，但这表明它 将重新操作率从9-18％降低到本质上为零，消除了对输血的需求，并减少了 住院时间增加43％，导管插入时间增加63％。 holm蒙部署不足的原因 激光手术很明确：由于缺乏灵巧性，该程序是外科医生要完成的挑战 当前的内窥镜仪器。目前，外科医生必须使用刚性内窥镜的尖端进行 立即三件事：针对激光纤维，可视化外科手术场，然后操纵组织切割。 我们假设灵巧的针大小的臂可用于瞄准激光并缩回组织 内窥镜提示将使该过程更容易执行，从而更广泛地采用程序 众所周知，这可以改善患者的预后。 这项工作的创新是，这是有史以来的第一个多臂手持手术机器人系统。更远- 与当前大型，昂贵且复杂的当前商业手术机器人系统相反，我们 系统将很小，具有成本效益，并且不需要复杂的外科医生控制台或铰接式操纵器系统 围绕病人。这些好处来自通过通过 标准临床内窥镜中的端口。手臂由望远镜，弯曲的弹性管制成。轴向 我们的机器人旋转并伸展伸展管，将为外科医生提供两个小的“触手状” 内窥镜尖端的操纵器。一个带有plaser纤维进行切割，另一个启用 撤回。 我们目标1的方法是设计适合监管批准的机器人系统，解决立体声 和制造性。在AIM 2中，我们实施安全系统以及基于软件的可靠性监视 方法。在AIM 3中，我们通过实验验证系统，定量比较外科医生的性能 使用我们的机器人系统达到当前的护理标准。该项目的结果是（1）操作室 - 现成的机器人系统，（2）使用完整的监管总体规划和（3）定量的FDA预提取 数据表明，我们的系统使以前尚未尝试过Holmium激光外科手术的外科医生与 速度和质量可与没有机器人的外科医生相提并论，而机器人已经进行了50多个病例（即，它消除了 目前阻止患者从此手术中受益的仪器灵巧障碍）。