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： 该提案的目的是改造用于经尿道激光的手持式手术机器人系统 前列腺手术从实验室原型转变为商业产品 该系统将配备针头大小的手臂。 通过内窥镜端口部署，将实现独立的组织操纵、激光瞄准和视觉 使手术更加精准、高效。 临床意义来自于 (1) 大量患者可以受益（三分之一的男性需要 美国每年有 300,000 例前列腺肥大手术——预计将翻倍 未来 10 年），以及 (2) 目前只有 1.7% 的患者从钬激光中受益 尽管多项随机试验证明了这一点，但我们还是力求促进这一过程。 将再手术率从 9-18% 降低至基本为零，消除了输血的需要，并减少了 住院时间减少 43%，导尿时间减少 63% 钬部署不足的原因。 激光手术很明确：由于缺乏灵活性，该手术对于外科医生来说很难完成。 当前内窥镜部署的器械 目前，外科医生必须使用硬质内窥镜的尖端来进行手术。 一次完成三件事：瞄准激光纤维、可视化手术区域以及将组织操纵到切割位置。 我们寻求使用灵巧的针头大小的手臂来瞄准激光并将组织缩回 内窥镜尖端将使手术更容易执行，从而促进手术的更广泛采用 众所周知，这可以改善患者的治疗结果。 这项工作的创新之处在于，这是第一个多臂手持式手术机器人系统。 此外，与当前大型、昂贵且复杂的商业手术机器人系统相比，我们的 系统体积小、成本效益高，并且不需要复杂的外科医生控制台或铰接式机械手系统 这些好处来自于通过身体输送针头大小的机械臂的能力。 标准临床内窥镜的端口由轴向伸缩的弯曲弹性管制成。 通过旋转和伸缩延伸管子，我们的机器人将为外科医生提供两个小的“触手状” 内窥镜尖端的机械手携带用于切割的钬激光光纤，另一个则能够进行切割。 撤回。 我们的目标 1 的方法是设计一个适合监管部门批准的机器人系统，解决无菌问题 在目标 2 中，我们实施安全系统以及基于软件的可靠性监控。 在目标 3 中，我们通过实验验证系统，定量比较外科医生的表现。 使用我们的机器人系统达到当前的护理标准，该项目的成果是（1）手术室- 准备好的机器人系统，(2) FDA 预先提交的完整监管总体规划，以及 (3) 定量 数据显示，我们的系统使以前没有尝试过钬激光手术的外科医生能够进行手术 速度和质量可与未使用机器人完成 50 多个病例的外科医生相媲美（即，它消除了 目前阻碍患者从该手术中受益的器械灵活性障碍）。