Enabling advanced endovascular beating-heart procedures through soft robotics

与标准的心脏直视手术相比，心脏不停跳手术不需要体外循环。 旁路手术为患者提供了相当大的优势，因为手术的侵入性更小，更少 围手术期并发症少，恢复时间短。然而，仍然存在几个工程挑战 这排除了通过血管内途径进行全方位重建外科手术的可能性，这 目前只能在打开和停止的心脏上做。目前的血管内途径仍然提供有限的 远端灵巧，缺乏传感器反馈，不适合施加大量的力。软机器人技术 有潜力成为这一领域的使能技术。事实上，软性和顺从的性质 构成机器人的材料将提供独特的优势，即能够局部支撑解剖 并安全地顺应心脏内部结构的运动。 该项目旨在开发一种可折叠在24Fr导管中的软机器人设备，可部署在 标准的X射线和三维超声成像，到达目标心腔，并执行操作任务 在移动的目标上。我们选择三尖瓣成形术(TV)作为示范手术来验证我们的 接近。带有机器人的导管将被插入颈内静脉，向上推进 下腔静脉(SVC)，并安全地支撑在SVC上，使机器人可以到达直径沿线的任何点 电视环带。软体机器人将被设计为在握住它的同时被动地服从电视环行运动 放置在靶子上，按顺序放置环状成形术线圈。 提出的工作有两个具体目标：目标1软可展开机器人的设计，重点是 根据临床规范设计和制造机器人，并对其功能进行测试。这个 机器人将我们组成：1-一个锚定部分，支撑在右上腔静脉的入口处 中庭，2-一个柔软的可折叠手臂，用于定位和定位机械手的尖端，以及3-3个柔软的触手 尖端，以提供远端操作能力和稳定设备的尖端。目标2：演示 机器人的功能，将重点放在整个平台的性能评估上。首先，体外和体外 将在组装的机器人上进行表征，其次将在体内进行验证 大型动物模型(约克郡猪)，将由准确和稳定的操作演示组成 心脏跳动中的功能，即在整个TV环周围放置成形术组织线圈 能够在不需要体外循环的情况下在不停跳的心脏内进行手术将为 在心脏跳动中进行重建程序，同时避免并发症的方法。在……里面 此外，通过解决这些挑战，我们可以导致新型仪器设计的范式转变，以 在身体难以触及的部位进行先进的微创手术，如肺、肾、 大脑，特别是在处理脆弱和移动的目标时。

In comparison with standard open-heart surgery, beating-heart procedures do not require cardiopulmonary bypass and provide considerable advantages to the patient in terms of less invasiveness of the procedure, fewer perioperative complications, and shorter recover time. However, there are still several engineering challenges that preclude performing full spectrum of reconstructive surgical procedures via endovascular approach, which currently can only be done on the open and stopped heart. Current endovascular approaches still provide limited distal dexterity, lack sensor feedback, and are not designed to apply significant amount of forces. Soft robotics has the potential of becoming an enabling technology in this field. Indeed, the soft and compliant nature of the materials that compose the robot will provide the unique advantage of being able to locally brace to anatomical structures and to safely comply with the motion of the internal structures of the heart. This project aims at developing a soft robotic device that can be folded in a 24 Fr catheter to be deployed under standard X-ray and 3D ultrasound imaging, reach the target cardiac chamber, and perform manipulation tasks on a moving target. We chose tricuspid valve (TV) annuloplasty as an exemplar procedure to validate our approach. The catheter with the robot will be inserted into the internal jugular vein, advanced toward the superior vena cava (SVC), and safely braced to the SVC, so that the robot can reach any point along the diameter of the TV annulus. The soft robot will be designed to passively comply with the TV annulus motion while holding its position on the target and perform sequential placements of annuloplasty coils. The proposed work is structured in two specific aims: Aim 1 Design of the soft deployable robot, focuses on the design and manufacturing of the robot, based on clinical specifications, and testing of its functionalities. The robot will we composed of: 1- an anchoring section to brace to the superior vena cava at the entrance of the right atrium, 2- a soft foldable arm to position and orient the tip of the manipulator, and 3- three soft tentacles at the tip, to provide distal manipulation capabilities and stabilize the tip of the device. Aim 2: demonstration of the robot functionality, will focus on the performance evaluation of the entire platform. At first, in-vitro and ex-vivo characterizations will be carried out on the assembled robot, secondly in-vivo validation will be performed on a large animal model (Yorkshire swine) and will consist of a demonstration of accurate and stable manipulation capabilities inside the beating heart i.e. placing the annuloplasty tissue coils around the entire TV annulus Being able to perform surgery inside a beating heart without the need for a cardiopulmonary bypass will pave the way to performing reconstructive procedures inside the beating heart while avoiding complications. In addition, by solving these challenges, we can lead to a paradigm shift in the design of novel instrumentation to perform advanced minimally invasive procedures in hard-to-reach areas of the body such as lungs, kidneys, brain, especially when dealing with delicate and mobile targets.