Percutaneous Steerable Robotic Tool Delivery Platform and Metal Microelectromechanical Systems Device for Tissue Manipulation and Approximation

Abstract

Background Beating-heart image-guided intracardiac interventions have been evolving rapidly. To extend the domain of catheter-based and transcardiac interventions into reconstructive surgery, a new robotic tool delivery platform (TDP) and tissue approximation device have been developed. Initial results employing these tools to perform patent foramen ovale (PFO) closure are described. Methods and Results A robotic TDP comprised of superelastic metal tubes provides the capability of delivering and manipulating tools and devices inside the beating heart. A new device technology is also presented that utilizes a metal-based MicroElectroMechanical Systems (MEMS) manufacturing process to produce fully-assembled and fully-functional millimeter-scale tools. As a demonstration of both technologies, a PFO creation and closure was performed in a swine model. In the first group of animals (N=10), a preliminary study was performed. The procedural technique was validated with a transcardiac handheld delivery platform and epicardial echocardiography, video-assisted cardioscopy and fluoroscopy. In the second group (N=9), the procedure was performed percutaneously using the robotic TDP under epicardial echocardiography and fluoroscopy imaging. All PFO’s were completely closed in the first group. In the second group, the PFO was not successfully created in 1 animal, and the defects were completely closed in 6 of the 8 remaining animals. Conclusions In contrast to existing robotic catheter technologies, the robotic TDP utilizes a combination of stiffness and active steerability along its length to provide the positioning accuracy and force application capability necessary for tissue manipulation. In combination with a MEMS tool technology, it can enable reconstructive procedures inside the beating heart.

A preliminary study on using a Robotically-Actuated Delivery Sheath (RADS) for transapical aortic valve implantation

“…However, tracking was limited to one degree-of-freedom (DOF) in that study. Vasilyev et al demonstrated a percutaneous steerable robotic tool delivery platform using pre-bent concentric tubes robot to treat patent foramen ovale [16]. Although the pre-bent concentric tubes robot could be adapted for valve delivery using transapical access, the design provides limited capabilities to compensate for respiratory and beating heart motions.…”

Tissue removal inside the beating heart using a robotically delivered metal MEMS tool

“…Active shape change is achieved by relative rotation and translation of the tubes at their base. Since they can be constructed with diameters similar to those of catheters and yet offer greater stiffness combined with the capability of shape control along their entire length, they provide an effective tool delivery technology for reconstructive procedures inside the beating heart (Gosline et al, 2012a(Gosline et al, , 2012bVasilyev et al, 2012Vasilyev et al, , 2013.…”

“…The approach has been validated with in vivo large animal experiments, which demonstrated a novel alternative to both catheter-delivered PFO closure devices and to surgical closure by suture (Gosline et al, 2012a;Vasilyev et al, 2013). This paper considers the task of tissue removal inside the beating heart.…”

Concentric Tube Robot Design and Optimization Based on Task and Anatomical Constraints

“…Path planning algorithms are also being developed to enable robot navigation within anatomical constraints [13], [18]. Clinical applications considered to date include neurosurgery [7], [19], lung surgery [13], [14], [18] and cardiac surgery [1], [15], [16], including in vivo demonstrations of percutaneous beating-heart intracardiac surgery in an animal model [16], [20]. …”

“…In particular, the neurosurgical example solves for a robot design that can safely navigate through both ventricles from a single insertion point while prior designs were constrained to navigating within a single ventricle [7]. We have also added an experimental validation of a robot design for intracardiac PFO closure by comparing it against a robot successfully employed in beating-heart procedures [16], [20]. …”