SBIR Phase I: Enhanced Dexterity Minimally Invasive Surgical Platform

该小型企业创新研究（SBIR）第一阶段项目旨在建立一种新型微创手术（MIS）技术平台的可行性，该平台通过低成本的机械设计提供增强的灵活性，直观的控制和自然的力反馈。微创手术是通过病人身上的小孔进行的？它通常涉及缝合、打结和精细解剖，所有这些都需要增强手术工具的灵活性。现有的MIS工具技术提供了一个可负担性和功能之间的选择。目前可用的低成本机械（或非机器人）工具要么缺乏必要的灵活性，要么操作起来违反直觉，导致外科医生疲劳和显著的培训要求。机器人工具提供了卓越的灵活性和直观的控制，但非常昂贵，许多医疗保健提供者和患者无法负担。建议的MIS技术克服了这种负担能力与功能权衡通过一种新的前臂安装工具配置和创新的并行运动虚拟中心机制，使工具输入关节与外科医生？的手腕。这导致了外科医生的自然和直观的运动传输？通过低成本的设计，不需要任何传感器，执行器，或计算机控制的工具的末端执行器的手。 该项目的更广泛影响/商业潜力将通过申报医疗器械技术的开发和商业化实现，该技术将使外科医生能够进行复杂的MIS手术，如结肠切除术和子宫切除术，这些手术需要在最少的培训和手术机器人成本的一小部分的情况下进行缝合、打结和精细解剖。此外，所提出的技术可以适用于任何类型的端部执行器（针驱动器、镊子、抓紧器、剪刀、牵开器等）。因此可以作为各种手术的平台技术。鉴于这种多功能性和减少的成本和培训负担，拟议的将使更广泛地采用管理信息系统，从而使其利益的社会更大的一部分。除了对患者的好处，MIS还提供了医疗保健成本的节省，由于缩短住院时间，减少术后止痛药，并降低术后并发症的风险。因此，MIS已经影响了几个外科专业，包括减肥、胃肠道、泌尿外科、腹部、妇科和心胸外科。尽管每年在美国进行数百万例MIS手术，但到目前为止，由于当前手术机器人的高成本、传统手持式器械的培训负担以及某些MIS手术的复杂性，更广泛的采用受到限制。

This Small Business Innovation Research (SBIR) Phase I project aims to establish the feasibility of a novel minimally invasive surgery (MIS) technology platform that provides enhanced dexterity, intuitive control, and natural force feedback via a low-cost mechanical design. MIS is performed through small holes on a patient?s body to minimize patient trauma, blood loss, and recovery time, and it generally involves suturing, knot-tying, and fine dissection, all of which require enhanced dexterity in the surgical tool. Existing MIS tool technology offers a choice between affordability and functionality. Currently available low-cost mechanical (or non-robotic) tools either lack the necessary dexterity or are counter-intuitive to operate, resulting in surgeon fatigue and significant training requirements. Robotic tools provide exceptional dexterity and intuitive control, but are very expensive and beyond the reach of many healthcare providers and patients. The proposed MIS technology overcomes this affordability versus functionality tradeoff via a novel forearm mounted tool configuration and innovations in parallel-kinematic virtual center mechanisms that makes the tool input joint coincident with the surgeon?s wrist. This results in a natural and intuitive motion transmission from the surgeon?s hand to the tool end-effector via a low-cost design that does not require any sensors, actuators, or computer-control. The broader impact/commercial potential of this project will be realized by the development and commercialization of the proposed medical device technology will enable surgeons to perform complex MIS procedures such as colectomy and hysterectomy that require suturing, knot-tying and fine dissection with minimal training and at a fraction of the cost of surgical robots. Moreover, the proposed technology can be adapted to any style of end-effector (needle driver, forceps, graspers, scissors, retractor, etc.) and therefore serves as a platform technology for all kinds of surgeries. Given this versatility and reduced cost and training burden, the proposed will enable a wider adoption of MIS, thereby bringing its benefits to a larger portion of the society. In addition to benefits to the patient, MIS also provides healthcare cost-savings due to shorter hospital stays, less postsurgical pain medication, and reduced risk of post-operative complications. Consequently, MIS has impacted several surgical specialties, including bariatric, gastrointestinal, urologic, abdominal, gynecological, and cardiothoracic. Although millions of MIS procedures are performed in the US each year, wider adoption has been limited so far by the high cost of current surgical robots, the training burden of traditional hand-held instruments, and the complexity of certain MIS procedures.