Enabling advanced endovascular beating-heart procedures through soft robotics

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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.