From Concept to Market: Surgical Robot Development

Surgical robotics and supporting technologies have really become a prime example of modern applied information technology infiltrating our everyday lives. The development of these systems spans across four decades, and only the last few years brought the market value and saw the rising customer base imagined already by the early developers. This chapter guides through the historical development of the most important systems, and provide references and lessons learnt for current engineers facing similar challenges. A special emphasis is put on system validation, assessment and clearance, as the most commonly cited barrier hindering the wider deployment of a system

A Survey on the Current Status and Future Challenges Towards Objective Skills Assessment in Endovascular Surgery

Minimally-invasive endovascular interventions have evolved rapidly over the past decade, facilitated by breakthroughs in medical imaging and sensing, instrumentation and most recently robotics. Catheter based operations are potentially safer and applicable to a wider patient population due to the reduced comorbidity. As a result endovascular surgery has become the preferred treatment option for conditions previously treated with open surgery and as such the number of patients undergoing endovascular interventions is increasing every year. This fact coupled with a proclivity for reduced working hours, results in a requirement for efficient training and assessment of new surgeons, that deviates from the “see one, do one, teach one” model introduced by William Halsted, so that trainees obtain operational expertise in a shorter period. Developing more objective assessment tools based on quantitative metrics is now a recognised need in interventional training and this manuscript reports the current literature for endovascular skills assessment and the associated emerging technologies. A systematic search was performed on PubMed (MEDLINE), Google Scholar, IEEXplore and known journals using the keywords, “endovascular surgery”, “surgical skills”, “endovascular skills”, “surgical training endovascular” and “catheter skills”. Focusing explicitly on endovascular surgical skills, we group related works into three categories based on the metrics used; structured scales and checklists, simulation-based and motion-based metrics. This review highlights the key findings in each category and also provides suggestions for new research opportunities towards fully objective and automated surgical assessment solutions

Context-aware learning for robot-assisted endovascular catheterization

Endovascular intervention has become a mainstream treatment of cardiovascular diseases. However, multiple challenges remain such as unwanted radiation exposures, limited two-dimensional image guidance, insufficient force perception and haptic cues. Fast evolving robot-assisted platforms improve the stability and accuracy of instrument manipulation. The master-slave system also removes radiation to the operator. However, the integration of robotic systems into the current surgical workflow is still debatable since repetitive, easy tasks have little value to be executed by the robotic teleoperation. Current systems offer very low autonomy, potential autonomous features could bring more benefits such as reduced cognitive workloads and human error, safer and more consistent instrument manipulation, ability to incorporate various medical imaging and sensing modalities. This research proposes frameworks for automated catheterisation with different machine learning-based algorithms, includes Learning-from-Demonstration, Reinforcement Learning, and Imitation Learning. Those frameworks focused on integrating context for tasks in the process of skill learning, hence achieving better adaptation to different situations and safer tool-tissue interactions. Furthermore, the autonomous feature was applied to next-generation, MR-safe robotic catheterisation platform. The results provide important insights into improving catheter navigation in the form of autonomous task planning, self-optimization with clinical relevant factors, and motivate the design of intelligent, intuitive, and collaborative robots under non-ionizing image modalities.Open Acces

Design of a Teleoperated Robotic Bronchoscopy System for Peripheral Pulmonary Lesion Biopsy

Bronchoscopy with transbronchial biopsy is a minimally invasive and effective method for early lung cancer intervention. Robot-assisted bronchoscopy offers improved precision, spatial flexibility, and reduced risk of cross-infection. This paper introduces a novel teleoperated robotic bronchoscopy system and a three-stage procedure designed for robot-assisted bronchoscopy. The robotic mechanism enables a clinical practice similar to traditional bronchoscopy, augmented by the control of a novel variable stiffness catheter for tissue sampling. A rapid prototype of the robotic system has been fully developed and validated through in-vivo experiments. The results demonstrate the potential of the proposed robotic bronchoscopy system and variable stiffness catheter in enhancing accuracy and safety during bronchoscopy procedures

Catheter Robots in the Cardiovascular System

Robotic-assisted endovascular therapy is a novel approach to augment precise skill requirements while simultaneously reducing radiation exposure. The CorPath system enhances the scope of minimally invasive procedures and facilitates the interventionalists to perform procedures in the field of vascular surgery, neurosurgery and interventional cardiology. The reason for increasing interest in the CorPath system is the ability to control these robots through wireless connection, raising the possibility for remote interventions. CorPath is currently the only commercially available endovascular robotic system. Robotic-assisted approach has a high technical success rate in the field of peripheral vascular and coronary interventions and has encouraging results regarding neurointerventions. Remote endovascular procedures may transform the future of stroke treatment in areas where distance-related time loss can affect procedural outcome

Evaluation of robotic catheter technology in complex endovascular intervention

The past four decades have witnessed tremendous strides in the evolution of endovascular devices and techniques. Catheter-based intervention has revolutionized the management of arterial disease allowing treatment of aortic and peripheral pathologies via a minimally invasive approach. Despite the exponential advances in endovascular equipment, devices and techniques, catheter-based endovascular intervention has certain morphological and technological constraints. Complex patient anatomy, technological impediments and suboptimal fluoroscopic imaging, can make endovascular intervention challenging using traditional endovascular means. Conventional endovascular catheters lack active manoeuvrability of the tip. Manual control can hinder overall stability and control at key target areas, leading to significantly prolonged overall procedure and fluoroscopic times. Repeated instrumentation increases the risk of vessel trauma and distal embolization. More importantly, guidewire-catheter skills are not necessarily intuitive but must be developed and are highly dependent on operator skill with long training pathways as a result. Recognizing the pressing need to address some of the limitations of standard catheter technology this thesis aims to evaluate the role of advanced robotic endovascular catheters in the aortic arch and the visceral segment. Clinical use of this technology is currently limited to transvenous cardiac mapping and ablation procedures. A comprehensive pre-clinical comparison and analysis of robotic versus manual catheter techniques is presented to reveal both their advantages and limitations, with particular emphasis on the potential of robotic catheter technology to reduce the manual skill required for complex tasks, improve stability at key target areas, reduce the risk of vessel trauma, embolization and radiation exposure, whilst improving overall operator performance. The worlds first clinical report of robot-assisted aortic aneurysm repair, a “proof - of - concept” resulting from this research, is also presented, and the potential for future advanced applications in order to increase the applicability of endovascular therapy to a larger cohort of patients discussed

Towards Image-Guided Pediatric Atrial Septal Defect Repair

Congenital heart disease occurs in 107.6 out of 10,000 live births, with Atrial Septal Defects (ASD) accounting for 10\% of these conditions. Historically, ASDs were treated with open heart surgery using cardiopulmonary bypass, allowing a patch to be sewn over the defect. In 1976, King et al. demonstrated use of a transcatheter occlusion procedure, thus reducing the invasiveness of ASD repair. Localization during these catheter based procedures traditionally has relied on bi-plane fluoroscopy; more recently trans-esophageal echocardiography (TEE) and intra-cardiac echocardiography (ICE) have been used to navigate these procedures. Although there is a high success rate using the transcatheter occlusion procedure, fluoroscopy poses radiation dose risk to both patient and clinician. The impact of this dose to the patients is important as many of those undergoing this procedure are children, who have an increased risk associated with radiation exposure. Their longer life expectancy than adults provides a larger window of opportunity for expressing the damaging effects of ionizing radiation. In addition, epidemiologic studies of exposed populations have demonstrated that children are considerably more sensitive to the carcinogenic effects radiation. Image-guided surgery (IGS) uses pre-operative and intra-operative images to guide surgery or an interventional procedure. Central to every IGS system is a software application capable of processing and displaying patient images, registration between multiple coordinate systems, and interfacing with a tool tracking system. We have developed a novel image-guided surgery framework called Kit for Navigation by Image Focused Exploration (KNIFE). This software system serves as the core technology by which a system for reduction of radiation exposure to pediatric patients was developed. The bulk of the initial work in this research endevaour was the development of KNIFE which itself went through countless iterations before arriving at its current state as per the feature requirements established. Secondly, since this work involved the use of captured medical images and their use in an IGS software suite, a brief analysis of the physics behind the images was conducted. Through this aspect of the work, intrinsic parameters (principal point and focal point) of the fluoroscope were quantified using a 3D grid calibration phantom. A second grid phantom was traversed through the fluoroscopic imaging volume of II and flat panel based systems at 2 cm intervals building a scatter field of the volume to demonstrate pincushion and \u27S\u27 distortion in the images. Effects of projection distortion on the images was assessed by measuring the fiducial registration error (FRE) of each point used in two different registration techniques, where both methods utilized ordinary procrustes analysis but the second used a projection matrix built from the fluoroscopes calculated intrinsic parameters. A case study was performed to test whether the projection registration outperforms the rigid transform only. Using the knowledge generated were able to successfully design and complete mock clinical procedures using cardiac phantom models. These mock trials at the beginning of this work used a single point to represent catheter location but this was eventually replaced with a full shape model that offered numerous advantages. At the conclusion of this work a novel protocol for conducting IG ASD procedures was developed. Future work would involve the construction of novel EM tracked tools, phantom models for other vascular diseases and finally clinical integration and use

Advanced tracking and image registration techniques for intraoperative radiation therapy

Mención Internacional en el título de doctorIntraoperative electron radiation therapy (IOERT) is a technique used to deliver radiation to the surgically opened tumor bed without irradiating healthy tissue. Treatment planning systems and mobile linear accelerators enable clinicians to optimize the procedure, minimize stress in the operating room (OR) and avoid transferring the patient to a dedicated radiation room. However, placement of the radiation collimator over the tumor bed requires a validation methodology to ensure correct delivery of the dose prescribed in the treatment planning system. In this dissertation, we address three well-known limitations of IOERT: applicator positioning over the tumor bed, docking of the mobile linear accelerator gantry with the applicator and validation of the dose delivery prescribed. This thesis demonstrates that these limitations can be overcome by positioning the applicator appropriately with respect to the patient’s anatomy. The main objective of the study was to assess technological and procedural alternatives for improvement of IOERT performance and resolution of problems of uncertainty. Image-to-world registration, multicamera optical trackers, multimodal imaging techniques and mobile linear accelerator docking are addressed in the context of IOERT. IOERT is carried out by a multidisciplinary team in a highly complex environment that has special tracking needs owing to the characteristics of its working volume (i.e., large and prone to occlusions), in addition to the requisites of accuracy. The first part of this dissertation presents the validation of a commercial multicamera optical tracker in terms of accuracy, sensitivity to miscalibration, camera occlusions and detection of tools using a feasible surgical setup. It also proposes an automatic miscalibration detection protocol that satisfies the IOERT requirements of automaticity and speed. We show that the multicamera tracker is suitable for IOERT navigation and demonstrate the feasibility of the miscalibration detection protocol in clinical setups. Image-to-world registration is one of the main issues during image-guided applications where the field of interest and/or the number of possible anatomical localizations is large, such as IOERT. In the second part of this dissertation, a registration algorithm for image-guided surgery based on lineshaped fiducials (line-based registration) is proposed and validated. Line-based registration decreases acquisition time during surgery and enables better registration accuracy than other published algorithms. In the third part of this dissertation, we integrate a commercial low-cost ultrasound transducer and a cone beam CT C-arm with an optical tracker for image-guided interventions to enable surgical navigation and explore image based registration techniques for both modalities. In the fourth part of the dissertation, a navigation system based on optical tracking for the docking of the mobile linear accelerator to the radiation applicator is assessed. This system improves safety and reduces procedure time. The system tracks the prescribed collimator location to solve the movements that the linear accelerator should perform to reach the docking position and warns the user about potentially unachievable arrangements before the actual procedure. A software application was implemented to use this system in the OR, where it was also evaluated to assess the improvement in docking speed. Finally, in the last part of the dissertation, we present and assess the installation setup for a navigation system in a dedicated IOERT OR, determine the steps necessary for the IOERT process, identify workflow limitations and evaluate the feasibility of the integration of the system in a real OR. The navigation system safeguards the sterile conditions of the OR, clears the space available for surgeons and is suitable for any similar dedicated IOERT OR.La Radioterapia Intraoperatoria por electrones (RIO) consiste en la aplicación de radiación de alta energía directamente sobre el lecho tumoral, accesible durante la cirugía, evitando radiar los tejidos sanos. Hoy en día, avances como los sistemas de planificación (TPS) y la aparición de aceleradores lineales móviles permiten optimizar el procedimiento, minimizar el estrés clínico en el entorno quirúrgico y evitar el desplazamiento del paciente durante la cirugía a otra sala para ser radiado. La aplicación de la radiación se realiza mediante un colimador del haz de radiación (aplicador) que se coloca sobre el lecho tumoral de forma manual por el oncólogo radioterápico. Sin embargo, para asegurar una correcta deposición de la dosis prescrita y planificada en el TPS, es necesaria una adecuada validación de la colocación del colimador. En esta Tesis se abordan tres limitaciones conocidas del procedimiento RIO: el correcto posicionamiento del aplicador sobre el lecho tumoral, acoplamiento del acelerador lineal con el aplicador y validación de la dosis de radiación prescrita. Esta Tesis demuestra que estas limitaciones pueden ser abordadas mediante el posicionamiento del aplicador de radiación en relación con la anatomía del paciente. El objetivo principal de este trabajo es la evaluación de alternativas tecnológicas y procedimentales para la mejora de la práctica de la RIO y resolver los problemas de incertidumbre descritos anteriormente. Concretamente se revisan en el contexto de la radioterapia intraoperatoria los siguientes temas: el registro de la imagen y el paciente, sistemas de posicionamiento multicámara, técnicas de imagen multimodal y el acoplamiento del acelerador lineal móvil. El entorno complejo y multidisciplinar de la RIO precisa de necesidades especiales para el empleo de sistemas de posicionamiento como una alta precisión y un volumen de trabajo grande y propenso a las oclusiones de los sensores de posición. La primera parte de esta Tesis presenta una exhaustiva evaluación de un sistema de posicionamiento óptico multicámara comercial. Estudiamos la precisión del sistema, su sensibilidad a errores cometidos en la calibración, robustez frente a posibles oclusiones de las cámaras y precisión en el seguimiento de herramientas en un entorno quirúrgico real. Además, proponemos un protocolo para la detección automática de errores por calibración que satisface los requisitos de automaticidad y velocidad para la RIO demostrando la viabilidad del empleo de este sistema para la navegación en RIO. Uno de los problemas principales de la cirugía guiada por imagen es el correcto registro de la imagen médica y la anatomía del paciente en el quirófano. En el caso de la RIO, donde el número de posibles localizaciones anatómicas es bastante amplio, así como el campo de trabajo es grande se hace necesario abordar este problema para una correcta navegación. Por ello, en la segunda parte de esta Tesis, proponemos y validamos un nuevo algoritmo de registro (LBR) para la cirugía guiada por imagen basado en marcadores lineales. El método propuesto reduce el tiempo de la adquisición de la posición de los marcadores durante la cirugía y supera en precisión a otros algoritmos de registro establecidos y estudiados en la literatura. En la tercera parte de esta tesis, integramos un transductor de ultrasonido comercial de bajo coste, un arco en C de rayos X con haz cónico y un sistema de posicionamiento óptico para intervenciones guiadas por imagen que permite la navegación quirúrgica y exploramos técnicas de registro de imagen para ambas modalidades. En la cuarta parte de esta tesis se evalúa un navegador basado en el sistema de posicionamiento óptico para el acoplamiento del acelerador lineal móvil con aplicador de radiación, mejorando la seguridad y reduciendo el tiempo del propio acoplamiento. El sistema es capaz de localizar el colimador en el espacio y proporcionar los movimientos que el acelerador lineal debe realizar para alcanzar la posición de acoplamiento. El sistema propuesto es capaz de advertir al usuario de aquellos casos donde la posición de acoplamiento sea inalcanzable. El sistema propuesto de ayuda para el acoplamiento se integró en una aplicación software que fue evaluada para su uso final en quirófano demostrando su viabilidad y la reducción de tiempo de acoplamiento mediante su uso. Por último, presentamos y evaluamos la instalación de un sistema de navegación en un quirófano RIO dedicado, determinamos las necesidades desde el punto de vista procedimental, identificamos las limitaciones en el flujo de trabajo y evaluamos la viabilidad de la integración del sistema en un entorno quirúrgico real. El sistema propuesto demuestra ser apto para el entorno RIO manteniendo las condiciones de esterilidad y dejando despejado el campo quirúrgico además de ser adaptable a cualquier quirófano similar.Programa Oficial de Doctorado en Multimedia y ComunicacionesPresidente: Raúl San José Estépar.- Secretario: María Arrate Muñoz Barrutia.- Vocal: Carlos Ferrer Albiac

Accurate modelling and positioning of a magnetically-controlled catheter tip

This thesis represents the initial phase of a proposed operator and patient friendly method designed to semi-automate the positioning and directing of an intravascular catheter in the human heart using a variable electromagnetically induced field to control a catheter tip equipped with three tiny fixed magnets oriented in XYZ planes. Here we demonstrate a comprehensive mathematical model which accurately calculates the magnetic field generated by the electromagnet system, and the magnetic torques and forces exerted on a three-magnet tip catheter. From this we have developed an iterative predictive computer algorithm to show the displacement and deflection of the catheter tip. Using an eight variable power electromagnet system around a 250mm sphere of air we have proven the ability of this to accurately move the catheter tip from an initial position to a designated position within the field

Image-Based Force Estimation and Haptic Rendering For Robot-Assisted Cardiovascular Intervention

Clinical studies have indicated that the loss of haptic perception is the prime limitation of robot-assisted cardiovascular intervention technology, hindering its global adoption. It causes compromised situational awareness for the surgeon during the intervention and may lead to health risks for the patients. This doctoral research was aimed at developing technology for addressing the limitation of the robot-assisted intervention technology in the provision of haptic feedback. The literature review showed that sensor-free force estimation (haptic cue) on endovascular devices, intuitive surgeon interface design, and haptic rendering within the surgeon interface were the major knowledge gaps. For sensor-free force estimation, first, an image-based force estimation methods based on inverse finite-element methods (iFEM) was developed and validated. Next, to address the limitation of the iFEM method in real-time performance, an inverse Cosserat rod model (iCORD) with a computationally efficient solution for endovascular devices was developed and validated. Afterward, the iCORD was adopted for analytical tip force estimation on steerable catheters. The experimental studies confirmed the accuracy and real-time performance of the iCORD for sensor-free force estimation. Afterward, a wearable drift-free rotation measurement device (MiCarp) was developed to facilitate the design of an intuitive surgeon interface by decoupling the rotation measurement from the insertion measurement. The validation studies showed that MiCarp had a superior performance for spatial rotation measurement compared to other modalities. In the end, a novel haptic feedback system based on smart magnetoelastic elastomers was developed, analytically modeled, and experimentally validated. The proposed haptics-enabled surgeon module had an unbounded workspace for interventional tasks and provided an intuitive interface. Experimental validation, at component and system levels, confirmed the usability of the proposed methods for robot-assisted intervention systems