Remote Navigation and Contact-Force Control of Radiofrequency Ablation Catheters

Atrial fibrillation (AF), the most common and clinically significant heart rhythm disorder, is characterized by rapid and irregular electrical activity in the upper chambers resulting in abnormal contractions. Radiofrequency (RF) cardiac catheter ablation is a minimally invasive curative treatment that aims to electrically correct signal pathways inside the atria to restore normal sinus rhythm. Successful catheter ablation requires the complete and permanent elimination of arrhythmogenic signals by delivering transmural RF ablation lesions contiguously near and around key cardiac structures. These procedures are complex and technically challenging and, even when performed by the most skilled physician, nearly half of patients undergo repeat procedures due to incomplete elimination of the arrhythmogenic pathways. This thesis aims to incorporate innovative design to improve catheter stability and maneuverability through the development of robotic platforms that enable precise placement of reproducibly durable ablation lesions. The first part of this thesis deals with the challenges to lesion delivery imposed by cardiorespiratory motion. One of the main determinants of the delivery of durable and transmural RF lesions is the ability to define and maintain a constant contact force between the catheter tip electrode and cardiac tissue, which is hampered by the presence of cardiorespiratory motion. To address this need, I developed and evaluated a novel catheter contact-force control device. The compact electromechanical add-on tool monitors catheter-tissue contact force in real-time and simultaneously adjusts the position of a force-sensing ablation catheter within a steerable sheath to compensate for the change in contact force. In a series of in vitro and in vivo experiments, the contact-force control device demonstrated an ability to: a) maintain an average force to within 1 gram of a set level; b) reduce contact-force variation to below 5 grams (2-8-fold improvement over manual catheter intervention); c) ensure the catheter tip never lost contact with the tissue and never approached dangerous force levels; and importantly, d) deliver reproducible RF ablation lesions regardless of cardiac tissue motion, which were of the same depth and volume as lesions delivered in the absence of tissue motion. In the second part of the thesis, I describe a novel steerable sheath and catheter robotic navigation system, which incorporates the catheter contact-force controller. The robotic platform enables precise and accurate manipulation of a remote conventional steerable sheath and permits catheter-tissue contact-force control. The robotic navigation system was evaluated in vitro using a phantom that combines stationary and moving targets within an in vitro model representing a beating heart. An electrophysiologist used the robotic system to remotely navigate the sheath and catheter tip to select targets and compared the accuracy of reaching these targets performing the same tasks manually. Robotic intervention resulted in significantly higher accuracy and significantly improved the contact-force profile between the catheter tip and moving tissue-mimicking material. Our studies demonstrate that using available contact-force information within a robotic system can ensure precise and accurate placement of reliably transmural RF ablation lesions. These robotic systems can be valuable tools used to optimize RF lesion delivery techniques and ultimately improve clinical outcomes for AF ablation therapy

Passive Resonant Coil Based Fast Registration And Tracking System For Real-Time Mri-Guided Minimally Invasive Surgery

This thesis presents a single-slice based fast stereotactic registration and tracking technique along with a corresponding modular system for guiding robotic mechanism or interventional instrument to perform needle-based interventions under live MRI guidance. The system can provide tracking of full 6 degree-of-freedom (DOF) in stereotactic interventional surgery based upon a single, rapidly acquired cross-sectional image. The whole system is constructed with a modular data transmission software framework and mechanical structure so that it supports remote supervision and manipulation between a 3D Matlab tracking user interface (UI) and an existing MRI robot controller by using the OpenIGTLink network communication protocol. It provides better closed-loop control by implementing a feedback output interface to the MRI-guided robot. A new compact fiducial frame design is presented, and the fiducial is wrapped with a passive resonant coil. The coil resonates at the Larmor frequency for 3T MRI to enhance signal strength and enable for rapid imaging. The fiducial can be attached near the distal end of the robot and coaxially with a needle so as to visualize target tissue and track the surgical tool synchronously. The MRI-compatible design of fiducial frame, robust tracking algorithm and modular interface allow this tracking system to be conveniently used on different robots or devices and in different size of MRI bores. Several iterations of the tracking fiducial and passive resonant coils were constructed and evaluated in a Phillips Achieva 3T MRI. To assess accuracy and robustness of the tracking algorithm, 25 groups of images with different poses were successively scanned along specific sequence in and MRI experiment. The translational RMS error along depth is 0.271mm with standard deviation of 0.277mm for totally 100 samples. The overall angular RMS error is less than 0.426 degree with standard deviation of 0.526 degree for totally 150 samples. The passive resonant coils were shown to significantly increase signal intensity in the fiducial relative to the surroundings and provide for rapid imaging with low flip angles

Intraoperative Navigation Systems for Image-Guided Surgery

Recent technological advancements in medical imaging equipment have resulted in a dramatic improvement of image accuracy, now capable of providing useful information previously not available to clinicians. In the surgical context, intraoperative imaging provides a crucial value for the success of the operation. Many nontrivial scientific and technical problems need to be addressed in order to efficiently exploit the different information sources nowadays available in advanced operating rooms. In particular, it is necessary to provide: (i) accurate tracking of surgical instruments, (ii) real-time matching of images from different modalities, and (iii) reliable guidance toward the surgical target. Satisfying all of these requisites is needed to realize effective intraoperative navigation systems for image-guided surgery. Various solutions have been proposed and successfully tested in the field of image navigation systems in the last ten years; nevertheless several problems still arise in most of the applications regarding precision, usability and capabilities of the existing systems. Identifying and solving these issues represents an urgent scientific challenge. This thesis investigates the current state of the art in the field of intraoperative navigation systems, focusing in particular on the challenges related to efficient and effective usage of ultrasound imaging during surgery. The main contribution of this thesis to the state of the art are related to: Techniques for automatic motion compensation and therapy monitoring applied to a novel ultrasound-guided surgical robotic platform in the context of abdominal tumor thermoablation. Novel image-fusion based navigation systems for ultrasound-guided neurosurgery in the context of brain tumor resection, highlighting their applicability as off-line surgical training instruments. The proposed systems, which were designed and developed in the framework of two international research projects, have been tested in real or simulated surgical scenarios, showing promising results toward their application in clinical practice

Robot Assisted Laser Osteotomy

In the scope of this thesis world\u27s first robot system was developed, which facilitates osteotomy using laser in arbitrary geometries with an overall accuracy below 0.5mm. Methods of computer and robot assisted surgery were reconsidered and composed to a workflow. Adequate calibration and registration methods are proposed. Further a methodology for transferring geometrically defined cutting trajectories into pulse sequences and optimized execution plans is developed

Quantitative Analysis of Three-Dimensional Cone-Beam Computed Tomography Using Image Quality Phantoms

In the clinical setting, weight-bearing static 2D radiographic imaging and supine 3D radiographic imaging modalities are used to evaluate radiographic changes such as, joint space narrowing, subchondral sclerosis, and osteophyte formation. These respective imaging modalities cannot distinguish between tissues with similar densities (2D imaging), and do not accurately represent functional joint loading (supine 3D imaging). Recent advances in cone-beam CT (CBCT) have allowed for scanner designs that can obtain weight-bearing 3D volumetric scans. The purpose of this thesis was to analyze, design, and implement advanced imaging techniques to quantify image quality parameters of reconstructed image volumes generated by a commercially-available CBCT scanner, and a novel ceiling-mounted CBCT scanner. In addition, imperfections during rotation of the novel ceiling-mounted CBCT scanner were characterized using a 3D printed calibration object with a modification to the single marker bead method, and prospective geometric calibration matrices

The beginning of a new era in bone surgery Effectiveness and clinical application of a cold-ablation and robot-guided laser osteotome

Most industrial laser applications utilize computer and robot assistance, for guidance, safety, repeatability, and precision. For industrial applications, the increase in throughput and the processing speed are in the foreground. Nevertheless, these tools cannot just be transferred into clinical and surgical use because the focus in surgical interventions is on the exact implementation of a unique plan. The patient, as an inaccurately defined workpiece, with its individual anatomy and pathology, ultimately needs a single lot planning. Nowadays, medical laser systems are hand driven. The possibility of working precision, as used in industry lasers, is not exhausted. Therefore, medical laser beams have to be coupled to robot guidance. But due to the over-size of commercially available tools, efficient and ergonomic work in an operating room is impossible. Integration of the systems such as the laser source, and the robot arm are needed. Another key issue for the accuracy of the robotic arm is the inclusion of a tracking system. All these issues were encountered developing CARLO®: a Cold-Ablation and Robot-guided Laser Osteotome. This PhD thesis is divided in three parts: - an in-vivo study in sheep, - an in-vitro / wetlab study on human cadavers, and - a theoretical-experimental study to evaluate biomechanical changes in different osteotomy pattern. To test the applicability of the system in an operation theatre similar environment, an in-vivo animal trial was performed. Additionally, we wanted to demonstrate that bone healing after laser osteotomy is not impaired compared to the standard tool the piezo-osteotome. In terms of new mineralized bone formation, histological and micro-CT analysis showed clearly a higher tendency towards the acceleration of the healing process in the laser group. Additionally, no signs of bone necrosis were seen. In addition to the pure functioning of the device, the applicability in the clinic is important for technology to prevail. Therefore, dummy tests for the ergonomics and cadaver tests for the simulation of "real" operations in the cranio-maxillofacial field were performed. Wetlab tests were conducted on human cadavers where different macro-retentive osteotomy patterns were performed. It could be demonstrated that our prototype shows advantages over the current state of the art cutting tools, e.g. reduced bone loss, precise and real-time navigated execution of predefined geometries of freely selected osteotomy patterns. This advantage can be implemented in another indication of our prototype in the cranio-maxillofacial field: in craniosynostosis surgery. We performed a study using finite element analysis to simulate incomplete osteotomies on the inner side of the bone flap to facilitate the re-shaping (skull molding). This biomechanical analysis intended to create basic knowledge in terms of the best stress vs. force relation to obtain the largest projected bone surface. Moreover, a human multicenter study is ready to start for the clinical introduction of the cold-ablation and robot-guided laser osteotome and to gain more experience and information for future work