SBIR Phase II: Enhanced Dexterity Minimally Invasive Surgical Platform

这个小型企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力是，更多的患者将受益于微创手术，在这种手术中，手术通过微小的切口完成。除了术后疼痛更少、疤痕更少、恢复更快等优点外，微创手术还因为住院时间更短、术后并发症风险更低而降低了医疗成本。微创手术影响所有外科专科，包括妇科、普通科、肥胖科、泌尿科和心胸外科。尽管美国每年进行的此类手术超过150万例，但目前手术机器人的高昂成本、传统手持器械的培训负担以及某些微创手术的复杂性限制了更广泛的采用。通过该项目开发的技术将使外科医生能够以手术机器人的一小部分成本进行复杂的微创手术，如子宫切除术，只需最少的培训。外科医生将受益于这种符合人体工程学的设计，它将显著减少与许多腹腔镜器械相关的工作场所伤害的发生率。这一开发努力将导致一种通用的平台技术，它可以影响几乎所有类型的手术，使微创手术能够得到更广泛的采用。拟议的项目旨在完成腹腔镜关节针驱动器的设计、开发、验证、验证、监管审批和商业推出。这种新的低成本微创手术技术提供了增强的灵活性和直观的控制，这是只有价值数百万美元的手术机器人才能看到的。微创手术是通过患者S身体上的小孔进行的，以最大限度地减少创伤、出血和恢复时间，通常涉及缝合、打结和精细解剖，所有这些都将受益于手术器械的灵活性增强。目前可用的低成本机械(非机器人)器械要么缺乏灵活性，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。机器人仪器提供了非凡的灵活性和直观的控制，但价格昂贵，许多医院和患者负担不起。建议的微创手术技术平台通过一种新颖的前臂安装式工具配置和并联运动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，从而克服了这种价格与功能之间的权衡。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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is that more patients will benefit from minimally invasive surgery, in which operations are completed through tiny incisions. In addition to patient benefits of less postsurgical pain, less scarring, and quicker recovery, minimally invasive surgery also reduces healthcare cost due to shorter hospital stays and lower risk of post-operative complications. Minimally invasive surgery impacts all surgical specialties, including gynecology, general, bariatric, urologic, and cardiothoracic. Although more than 1.5 million such procedures are performed in the US each year, wider adoption is limited by the high cost of current surgical robots, training burden of traditional hand-held instruments, and complexity of certain minimally invasive procedures. The technology developed via this project will enable surgeons to perform complex minimally invasive procedures such as hysterectomy with minimal training and at a fraction of the cost of surgical robots. Surgeons will benefit from this ergonomic design that will significantly reduce the incidence of workplace related injury associated with many laparoscopic instruments. This development effort will lead to a versatile platform technology that can impact nearly all kinds of surgeries enabling a wider adoption of minimally invasive surgery. The proposed project aims to complete the design, development, verification, validation, regulatory clearance and commercial launch of a laparoscopic articulating needle driver. This novel low-cost minimally invasive surgery technology provides enhanced dexterity and intuitive control that is seen only in multi-million dollar surgical robots. Minimally invasive surgery is performed through small holes on a patient?s body to minimize trauma, blood loss, and recovery time, and generally involves suturing, knot-tying, and fine dissection, all of which would benefit from enhanced dexterity in the surgical instrument. Currently available low-cost mechanical (non-robotic) instruments either lack dexterity or are counter-intuitive to operate, resulting in surgeon fatigue and significant training requirements. Robotic instruments provide exceptional dexterity and intuitive control, but are costly and beyond the reach of many hospitals and patients. The proposal minimally invasive surgery technology platform 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.