Patient-Specific Neurovascular Simulator for Evaluating the Performance of Medical Robots and Instrumens

Proceedings of the 2006 IEEE International Conference on Robotics and Automation, Orlando, Florida, May 200

In-silico clinical trials for assessment of intracranial flow diverters

In-silico trials refer to pre-clinical trials performed, entirely or in part, using individualised computer models that simulate some aspect of drug effect, medical device, or clinical intervention. Such virtual trials reduce and optimise animal and clinical trials, and enable exploring a wider range of anatomies and physiologies. In the context of endovascular treatment of intracranial aneurysms, in-silico trials can be used to evaluate the effectiveness of endovascular devices over virtual populations of patients with different aneurysm morphologies and physiologies. However, this requires (i) a virtual endovascular treatment model to evaluate device performance based on a reliable performance indicator, (ii) models that represent intra- and inter-subject variations of a virtual population, and (iii) creation of cost-effective and fully-automatic workflows to enable a large number of simulations at a reasonable computational cost and time. Flow-diverting stents have been proven safe and effective in the treatment of large wide-necked intracranial aneurysms. The presented thesis aims to provide the ingredient models of a workflow for in-silico trials of flow-diverting stents and to enhance the general knowledge of how the ingredient models can be streamlined and accelerated to allow large-scale trials. This work contributed to the following aspects: 1) To understand the key ingredient models of a virtual treatment workflow for evaluation of the flow-diverter performance. 2) To understand the effect of input uncertainty and variability on the workflow outputs, 3) To develop generative statistical models that describe variability in internal carotid artery flow waveforms, and investigate the effect of uncertainties on quantification of aneurysmal wall shear stress, 4) As part of a metric to evaluate success of flow diversion, to develop and validate a thrombosis model to assess FD-induced clot stability, and 5) To understand how a fully-automatic aneurysm flow modelling workflow can be built and how computationally inexpensive models can reduce the computational costs

Haemostasis in endoscopic skull base surgery

The endoscopic approach to the skull base has revolutionised surgery in this region. Neurosurgery involves working around anatomical structures that are uniquely sensitive to damage and manipulation and patients may be left with the potentially devastating consequences of violating these structures. The endoscope allows the surgeon to visualise and reach areas that were previously only accessible with large amounts of destructive dissection. Tumours are able to be removed and aneurysms clipped without the need for large craniotomies and bony drilling. There are, however, drawbacks. The midline endoscopic route takes the surgeon between the carotid arteries. It potentially violates the anterior communicating artery complex and the basilar artery region anterior to the brainstem. These are important arteries that supply critical structures. Damage to these, or diminution of blood flow through them, results in profound neurological dysfunction or death. The rate of damage to the carotid artery with these approaches ranges from 1.1-9% depending on the specific approach and pathology. The carotid artery in this region does not generally lend itself to suturing, clipping or direct closure methods. Currently, the gold standard for repair is the application of crushed muscle patch to stop the bleeding and seal the vessel. The drawbacks to this are that it takes time to harvest and control the bleed (generally requiring 2 surgeons), and that there is a risk of pseudoaneurysm formation post recovery. This thesis describes novel techniques that may replace the muscle patch in order that a single surgeon may have this technique available to them immediately. Aims: To demonstrate the use of fibrin/thrombin/gelatin patches, fibrin/thrombin glues, beta-chitosan patches and self-assembling peptides on a sheep model of carotid artery haemorrhage and quantify the rate of pseudoaneurysm formation. To show the percentage of platelets activated by crushed and uncrushed muscle, chitosan, and fibrin and thrombin patches and gels using flow cytometry to further delineate the mechanism of action of crushed muscle as a haemostatic agent. To quantify the stress response in surgeons training on this sheep vascular haemorrhage model de novo, to quantify its effect on surgeons’ teamwork and communication skills, and determine the effect and value of training on modulation of this stress response.Thesis (Ph.D.) (Research by Publication) -- University of Adelaide, Adelaide Medical School, 201

Using the Fringe Field of MRI Scanner for the Navigation of Microguidewires in the Vascular System

Le traitement du cancer, la prévention des accidents vasculaires cérébraux et le diagnostic ou le traitement des maladies vasculaires périphériques sont tous des cas d'application d'interventions à base de cathéter par le biais d'un traitement invasif minimal. Cependant, la pratique du cathétérisme est généralement pratiquée manuellement et dépend fortement de l'expérience et des compétences de l'interventionniste. La robotisation du cathétérisme a été étudiée pour faciliter la procédure en augmentant les niveaux d’autonomie par rapport à cette pratique clinique. En ce qui concerne ce problème, un des problèmes concerne le placement super sélectif du cathéter dans les artères plus étroites nécessitant une miniaturisation de l'instrument cathéter / fil de guidage attaché. Un microguide qui fonctionne dans des vaisseaux sanguins étroits et tortueux subit différentes forces mécaniques telles que le frottement avec la paroi du vaisseau. Ces forces peuvent empêcher la progression de la pointe du fil de guidage dans les vaisseaux. Une méthode proposée consiste à appliquer une force de traction à la pointe du microguide pour diriger et insérer le dispositif tout en poussant l’instrument attaché à partir de l’autre extrémité n’est plus pratique, et à exploiter le gradient du champ de franges IRM surnommé Fringe Field Navigation (FFN ) est proposée comme solution pour assurer cet actionnement. Le concept de FFN repose sur le positionnement d'un patient sur six DOF dans le champ périphérique du scanner IRM afin de permettre un actionnement directionnel pour la navigation du fil-guide. Ce travail rend compte des développements requis pour la mise en oeuvre de la FFN et l’étude du potentiel et des possibilités qu’elle offre au cathétérisme, en veillant au renforcement de l’autonomie. La cartographie du champ de franges d'un scanner IRM 3T est effectuée et la structure du champ de franges en ce qui concerne son uniformité locale est examinée. Une méthode pour la navigation d'un fil de guidage le long d'un chemin vasculaire souhaité basée sur le positionnement robotique du patient à six DOF est développée. Des expériences de FFN guidées par rayons X in vitro et in vivo sur un modèle porcin sont effectuées pour naviguer dans un fil de guidage dans la multibifurcation et les vaisseaux étroits. Une caractéristique unique de FFN est le haut gradient du champ magnétique. Il est démontré in vitro et in vivo que cette force surmonte le problème de l'insertion d'un fil microguide dans des vaisseaux tortueux et étroits pour permettre de faire avancer le fil-guide avec une distale douce au-delà de la limite d'insertion manuelle. La robustesse de FFN contre les erreurs de positionnement du patient est étudiée en relation avec l'uniformité locale dans le champ périphérique. La force élevée du champ magnétique disponible dans le champ de franges IRM peut amener les matériaux magnétiques doux à son état de saturation. Ici, le concept d'utilisation d'un ressort est présenté comme une alternative vi déformable aux aimants permanents solides pour la pointe du fil-guide. La navigation d'un microguide avec une pointe de ressort en structure vasculaire complexe est également réalisée in vitro. L'autonomie de FFN en ce qui concerne la planification d'une procédure avec autonomie de tâche obtenue dans ce travail augmente le potentiel de FFN en automatisant certaines étapes d'une procédure. En conclusion, FFN pour naviguer dans les microguides dans la structure vasculaire complexe avec autonomie pour effectuer le positionnement du patient et contrôler l'insertion du fil de guidage - avec démonstration in vivo dans un modèle porcin - peut être considéré comme un nouvel outil robotique facilitant le cathétérisme vasculaire. tout en aidant à cibler les vaisseaux lointains dans le système vasculaire.----------ABSTRACT Treatment of cancer, prevention of stroke, and diagnosis or treatment of peripheral vascular diseases are all the cases of application of catheter-based interventions through a minimal-invasive treatment. However, performing catheterization is generally practiced manually, and it highly depends on the experience and the skills of the interventionist. Robotization of catheterization has been investigated to facilitate the procedure by increasing the levels of autonomy to this clinical practice. Regarding it, one issue is the super selective placement of the catheter in the narrower arteries that require miniaturization of the tethered catheter/guidewire instrument. A microguidewire that operates in narrow and tortuous blood vessels experiences different mechanical forces like friction with the vessel wall. These forces can prevent the advancement of the tip of the guidewire in the vessels. A proposed method is applying a pulling force at the tip of the microguidewire to steer and insert the device while pushing the tethered instrument from the other end is no longer practical, and exploiting the gradient of the MRI fringe field dubbed as Fringe Field Navigation (FFN) is proposed as a solution to provide this actuation. The concept of FFN is based on six DOF positioning of a patient in the fringe field of the MRI scanner to enable directional actuation for the navigation of the guidewire. This work reports on the required developments for implementing FFN and investigating the potential and the possibilities that FFN introduces to the catheterization, with attention to enhancing the autonomy. Mapping the fringe field of a 3T MRI scanner is performed, and the structure of the fringe field regarding its local uniformity is investigated. A method for the navigation of a guidewire along a desired vascular path based on six DOF robotic patient positioning is developed. In vitro and in vivo x-ray Guided FFN experiments on a swine model of are performed to navigate a guidewire in the multibifurcation and narrow vessels. A unique feature of FFN is the high gradient of the magnetic field. It is demonstrated in vitro and in vivo that this force overcomes the issue of insertion of a microguidewire in tortuous and narrow vessels to enable advancing the guidewire with a soft distal beyond the limit of manual insertion. Robustness of FFN against the error in the positioning of the patient is investigated in relation to the local uniformity in the fringe field. The high strength of the magnetic field available in MRI fringe field can bring soft magnetic materials to its saturation state. Here, the concept of using a spring is introduced as a deformable alternative to solid permanent magnets for the tip of the guidewire. Navigation of a microguidewire with a viii spring tip in complex vascular structure is also performed in vitro. The autonomy of FFN regarding planning a procedure with Task Autonomy achieved in this work enhances the potential of FFN by automatization of certain steps of a procedure. As a conclusion, FFN to navigate microguidewires in the complex vascular structure with autonomy in performing tasks of patient positioning and controlling the insertion of the guidewire – with in vivo demonstration in swine model – can be considered as a novel robotic tool for facilitating the vascular catheterization while helping to target remote vessels in the vascular system

Front Lines of Thoracic Surgery

Front Lines of Thoracic Surgery collects up-to-date contributions on some of the most debated topics in today's clinical practice of cardiac, aortic, and general thoracic surgery,and anesthesia as viewed by authors personally involved in their evolution. The strong and genuine enthusiasm of the authors was clearly perceptible in all their contributions and I'm sure that will further stimulate the reader to understand their messages. Moreover, the strict adhesion of the authors' original observations and findings to the evidence base proves that facts are the best guarantee of scientific value. This is not a standard textbook where the whole discipline is organically presented, but authors' contributions are simply listed in their pertaining subclasses of Thoracic Surgery. I'm sure that this original and very promising editorial format which has and free availability at its core further increases this book's value and it will be of interest to healthcare professionals and scientists dedicated to this field

CathSim: An Open-Source Simulator for Endovascular Intervention

Autonomous robots in endovascular operations have the potential to navigate circulatory systems safely and reliably while decreasing the susceptibility to human errors. However, there are numerous challenges involved with the process of training such robots, such as long training duration and safety issues arising from the interaction between the catheter and the aorta. Recently, endovascular simulators have been employed for medical training but generally do not conform to autonomous catheterization due to the lack of standardization and RL framework compliance. Furthermore, most current simulators are closed-source, which hinders the collaborative development of safe and reliable autonomous systems through shared learning and community-driven enhancements. In this work, we introduce CathSim, an open-source simulation environment that accelerates the development of machine learning algorithms for autonomous endovascular navigation. We first simulate the high-fidelity catheter and aorta with a state-of-the-art endovascular robot. We then provide the capability of real-time force sensing between the catheter and the aorta in simulation. Furthermore, we validate our simulator by conducting two different catheterization tasks using two popular reinforcement learning algorithms, namely SAC and PPO. The experimental results show that our open-source simulator can mimic the behavior of real-world endovascular robots and facilitate the development of different autonomous catheterization tasks. Our simulator is publicly available at https://github.com/airvlab/cathsim

Translation of Intravascular Optical Ultrasound Imaging

ances in the field of intravascular imaging have provided clinicians with power ful tools to aid in the assessment and treatment of vascular pathology. Optical Ultra sound (OpUS) is an emerging modality with the potential to offer significant bene fits over existing commercial technologies such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT). With this paradigm ultrasound (US) is generated using pulsed or modulated light and received by a miniaturised fibre-optic hydrophone (FOH). The US generation is facilitated through the use of engineered optically-absorbing nanocomposite materials. To date pre-clinical benchtop stud ies of OpUS have shown significant promise however further study is needed to facilitate clinical translation. The overall aim of this PhD was to develop a pathway to clinical translation of OpUS, enabled by the development of a catheter-based device capable of high resolution vascular tissue imaging during an in-vivo setting. A forward-viewing OpUS imaging probe was developed using a 400 µm mul timode optical fibre, dip-coated in a multi-walled carbon nanotube-PDMS com posite, paired with a FOH comprising a 125 µm single mode fibre tipped with a Fabry-Perot cavity. With this high US pressures were generated (21.5 MPa at the transducer surface) and broad corresponding bandwidths were achieved (−6 dB of 39.8MHz). Using this probe, OpUS imaging was performed of an ex-vivo human coronary artery. The results demonstrated excellent correspondence, in the detec tion of calcification and lipid infiltration, with IVUS, OCT and histological analysis. A side-viewing OpUS imaging probe, employing a reflective 45 °angle at the dis tal fibre surface, was used to demonstrate rotational B-mode imaging of a vascular structure for the first time. This provided high-resolution imaging (54 µm axial resolution) with deep depth penetration (>10.5 mm). Finally the clinical utility of this technology was demonstrated during an in-vivo endovascular procedure. An OpUS imaging probe, incorporated into an interventional device, allowed guidance of in-situ fenestration of an endograft during a complex abdominal aortic aneurysm repair. Through this work the potential clinical utility of OpUS, to assess pathology and guide vascular intervention, has been demonstrated. These results pave the way for translation of this technology and a first in man study

Improving Cardiovascular Stent Design Using Patient-Specific Models and Shape Optimization

Stent geometry influences local hemodynamic alterations (i.e. the forces moving blood through the cardiovascular system) associated with adverse clinical outcomes. Computational fluid dynamics (CFD) is frequently used to quantify stent-induced hemodynamic disturbances, but previous CFD studies have relied on simplified device or vascular representations. Additionally, efforts to minimize stent-induced hemodynamic disturbances using CFD models often only compare a small number of possible stent geometries. This thesis describes methods for modeling commercial stents in patient-specific vessels along with computational techniques for determining optimal stent geometries that address the limitations of previous studies. An efficient and robust method was developed for virtually implanting stent models into patient-specific vascular geometries derived from medical imaging data. Models of commercial stent designs were parameterized to allow easy control over design features. Stent models were then virtually implanted into vessel geometries using a series of Boolean operations. This approach allowed stented vessel models to be automatically regenerated for rapid analysis of the contribution of design features to resulting hemodynamic alterations. The applicability of the method was demonstrated with patient-specific models of a stented coronary artery bifurcation and basilar trunk aneurysm to reveal how it can be used to investigate differences in hemodynamic performance in complex vascular beds for a variety of clinical scenarios. To identify hemodynamically optimal stents designs, a computational framework was constructed to couple CFD with a derivative-free optimization algorithm. The optimization algorithm was fully-automated such that solid model construction, mesh generation, CFD simulation and time-averaged wall shear stress (TAWSS) quantification did not require user intervention. The method was applied to determine the optimal number of circumferentially repeating stent cells (NC) for a slotted-tube stents and various commercial stents. Optimal stent designs were defined as those minimizing the area of low TAWSS. It was determined the optimal value of NC is dependent on the intrastrut angle with respect to the primary flow direction. Additionally, the geometries of current commercial stents were found to generally incorporate a greater NC than is hemodynamically optimal. The application of the virtual stent implantation and optimization methods may lead to stents with superior hemodynamic performance and the potential for improved clinical outcomes. Future in vivo studies are needed to validate the findings of the computational results obtained from the methods developed in this thesis

Tuning of boundary conditions parameters for hemodynamics simulation using patient data

This thesis describes an engineering workflow, which allows specification of boundary conditions and 3D simulation based on clinically available patient-specific data. A review of numerical models used to describe the cardiovascular system is provided, with a particular focus on the clinical target disease chosen for the toolkit, aortic coarctation. Aorta coarctation is the fifth most common congenital heart disease, characterized by a localized stenosis of the descending thoracic aorta. Current diagnosis uses invasive pressure measurement with rare but potential complications. The principal objective of this work was to develop a tool that can be translated into the clinic, requiring minimum operator input and time, capable of returning meaningful results from data typically acquired in clinical practice. Linear and nonlinear 1D modelling approaches are described, tested against full 3D solutions derived for idealized geometries of increasing complexityand for a patient-specific aortic coarctation. The 1D linear implementation is able to represent the fluid dynamic in simple idealized benchmarks with a limited effort in terms of computational time, but in a more complex case, such as a mild aortic coarctation, it is unable to predict well 3D fluid dynamic features. On the other side, the 1D nonlinear implementation showed a good agreement when compared to 3D pressure and flow waveforms, making it suitable to estimate outflow boundary conditions for subject-specific models. A cohort of 11 coarctation patients was initially used for a preliminary analysis using 0D models of increasing complexity to examine parameters derived when tuning models of the peripheral circulation. The first circuit represents the aortic coarctation as a nonlinear resistance, using the Bernoulli pressure drop equation, without considering the effect of downstream circulation. The second circuit include a peripheral resistance and compliance, and separate ascending and descending aortic pressure responses. In the third circuit a supra-aortic Windkessel model was added in order to include the supra-aortic circulation. The analysis detailed represents a first attempt to assess the interaction between local aortic haemodynamics and subject-specific parameterization of windkessel representations of the peripheral and supra-aortic circulation using clinically measured data. From the analysis of these 0D models, it is clear that the significance of the coarctation becomes less from the simple two resistance model to the inclusion of both the peripheral and supra-aortic circulation. These results provide a context within which to interpret outcomes of the tuning process reported for a more complex model of aortic haemodynamics using 1D and 3D model approaches. Earlier developments are combined to enable a multi-scale modelling approach to simulate fluid-dynamics. This includes non-linear 1D models to derive patient-specific parameters for the peripheral and supra-aortic circulation followed by transient analysis of a coupled 3D/0D system to estimate the coarctation pressure augmentation. These predictions are compared with invasively measured catheter data and the influence of uncertainty in measured data on the tuning process is discussed. This study has demonstrated the feasibility of constructing a workflow using non-invasive routinely collected clinical data to predict the pressure gradient in coarctation patients using patient specific CFD simulation, with relatively low levels of user interaction required. The results showed that the model is not suitable for the clinical use at this stage, thus further work is required to enhance the tuning process to improve agreement with measured catheter data. Finally, a preliminary approach for the assessment of change in haemodynamics following coarctation repair, where the coarctation region is enlarged through a virtual intervention process. The CFD approach reported can be expanded to explore the sensitivity of the peak ascending aortic pressure and descending aortic flow to the aortic diameter achieved following intervention, such an analysis would provide guidance for surgical intervention to target the optimal diameter to restore peripheral perfusion and reduce cerebral hypertension