A Hand-Held Robot to Cure BPH

项目概要/摘要： 本提案的目的是将手持式手术机器人系统改造为经尿道激光手术系统 前列腺手术从实验室原型变成商业产品。该系统将采用针头大小的手臂 通过内窥镜端口展开，并将实现独立的组织操作、激光瞄准和视觉- 使手术更加准确和有效。 临床意义来自（1）大量患者可能贝内（1/3的男性需要 前列腺肥大（BPH）手术;美国每年有30万例手术，预计将翻一番 在未来10年内），以及（2）这些患者中目前只有1.7%贝内于钬激光的事实- 我们寻求的是一种便利的程序。尽管多项随机对照试验表明， 将再手术率从9-18%降低到基本为零，消除了输血的需要， 住院时间缩短43%，导管插入时间缩短63%。钬植入不足的原因 激光手术是明确的：该程序是具有挑战性的外科医生完成，由于缺乏灵活性， 当前的内窥镜展开器械。目前，外科医生必须使用刚性内窥镜的尖端来完成 一次完成三件事：瞄准激光纤维，可视化手术区域，并将组织移动到切割位置。 我们假设，灵巧的针头大小的手臂瞄准激光和回缩组织在 内窥镜尖端将使手术更容易进行，从而促进手术的更广泛采用 这是已知的改善病人的结果。 这项工作的创新之处在于，这是有史以来第一个多臂手持式手术机器人系统。此外─ 此外，与目前大型、昂贵和复杂的商业手术机器人系统相比， 系统将是小型、成本有效的，且不需要复杂的外科医生控制台或铰接式操纵器系统 围绕着病人。这些贝内来自于能够将针头大小的机械臂通过 标准临床内窥镜中的端口。臂由伸缩的弯曲的弹性管制成。通过轴向 我们的机器人将为外科医生提供两个小的“触手状”， 内窥镜尖端的操纵器。一个携带用于切割的钬激光纤维，另一个使 收回 我们在目标1中的方法是设计一个适合监管批准的机器人系统，解决无菌问题 和可制造性。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 接近。在目标3中，我们通过实验验证了系统，定量比较了外科医生的表现 与我们的机器人系统相匹配该项目的成果是（1）手术室- 准备好的机器人系统，（2）FDA预提交完整的监管主计划，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 速度和质量与没有机器人的外科医生相当，他们已经做了50多个病例（即它消除了 目前阻止患者从该手术中贝内的器械灵活性障碍）。

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).