SBIR Phase I: Enhanced Dexterity Minimally Invasive Surgical Platform

这个小型企业创新研究(SBIR)第一阶段项目旨在建立一种新的微创手术(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、直观的控制和自然力反馈。MI是通过患者S身体上的小孔进行的，以最大限度地减少患者的创伤、出血和恢复时间，通常涉及缝合、打结和精细解剖，所有这些都需要提高手术工具的灵活性。现有的管理信息系统工具技术在可负担性和功能性之间提供了选择。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，要么操作起来与直觉相反，导致外科医生疲劳和大量培训需求。机器人工具提供了非凡的灵活性和直观的控制，但非常昂贵，超出了许多医疗保健提供者和患者的承受能力。拟议的管理信息系统技术通过一种新颖的前臂安装式工具配置和并联虚拟中心机构的创新，使工具输入关节与外科医生S手腕重合，从而克服了这种负担能力和功能之间的权衡。这使得外科医生S的手通过不需要任何传感器、执行器或计算机控制的低成本设计自然而直观地传输到工具末端执行器。该项目的更广泛的影响/商业潜力将通过拟议的医疗设备技术的开发和商业化而实现，这将使外科医生能够执行复杂的管理信息系统程序，如结肠切除术和子宫切除术，这些程序需要最少的培训和最少的培训就能完成需要缝合、打结和精细解剖的手术机器人，而且成本只有手术机器人的一小部分。此外，建议的技术可以适用于任何类型的末端执行器(针头驱动器、钳子、抓取器、剪刀、牵引器等)。因此成为各种手术的平台技术。鉴于这种多功能性以及减少的成本和培训负担，拟议的管理信息系统将使更广泛地采用管理信息系统，从而使其惠及更多的社会阶层。除了给患者带来好处外，管理信息系统还提供了医疗成本节约，因为住院时间更短，术后止痛药更少，手术后并发症的风险也更低。因此，管理信息系统已经影响了几个外科专科，包括减肥、胃肠、泌尿外科、腹部、妇科和心胸外科。尽管美国每年进行数百万次的管理信息系统程序，但到目前为止，由于目前手术机器人的高昂成本、传统手持式仪器的训练负担以及某些管理信息系统程序的复杂性，更广泛的采用受到了限制。

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.