Catheter Localization Utilizing a Sensor-Enabled Guidewire: Design of a Proof-of-Concept System

The purpose of this thesis project was to develop a proof-of-concept system for tracking the tip of a catheter without an embedded electromagnetic sensor by utilizing a sensor enabled guidewire. The motivation for the project was a reduction fluoroscopy radiation dose for clinicians in the interventional cardiology lab and the extension of navigation technology to be used with a wider variety of interventional devices through the implementation of expanded capabilities of the Abbott MediGuide system. The focus of the project was on the development of a proof-of-concept system capable of using an external device to track relative guidewire and catheter motion and apply that to a calculated position in the vasculature. The research conducted covered multiple disciplines from mechanical design to software algorithms. A prototype system was developed that functions alongside the MediGuide system to provide a three dimensional depiction of catheter location and a measurement of the relative linear displacement separating the distal tip of the guidewire and the distal tip of the catheter. The system consists of an electromechanical device to measure relative motion and software to communicate with the device, interpret recorded guidewire position data into a representative trajectory, and display the results to the user. The hardware and software components of the project were evaluated to determine accuracy and precision. The prototype device was determined to be accurate to 0.7±0.03% of total displacement. In a simulated use procedure the device was determined to be accurate to 1.4±0.53mm. The software algorithms to generate a simulated guidewire path were evaluated and tuned to generate the best response to the data sets available. In summary, the work performed here shows the possibility of implementing a device and software system that can provide localization information to the operator about the catheters used in an interventional procedure without the need for a sensor in the catheter

Augmented Image-Guidance for Transcatheter Aortic Valve Implantation

The introduction of transcatheter aortic valve implantation (TAVI), an innovative stent-based technique for delivery of a bioprosthetic valve, has resulted in a paradigm shift in treatment options for elderly patients with aortic stenosis. While there have been major advancements in valve design and access routes, TAVI still relies largely on single-plane fluoroscopy for intraoperative navigation and guidance, which provides only gross imaging of anatomical structures. Inadequate imaging leading to suboptimal valve positioning contributes to many of the early complications experienced by TAVI patients, including valve embolism, coronary ostia obstruction, paravalvular leak, heart block, and secondary nephrotoxicity from contrast use. A potential method of providing improved image-guidance for TAVI is to combine the information derived from intra-operative fluoroscopy and TEE with pre-operative CT data. This would allow the 3D anatomy of the aortic root to be visualized along with real-time information about valve and prosthesis motion. The combined information can be visualized as a `merged\u27 image where the different imaging modalities are overlaid upon each other, or as an `augmented\u27 image, where the location of key target features identified on one image are displayed on a different imaging modality. This research develops image registration techniques to bring fluoroscopy, TEE, and CT models into a common coordinate frame with an image processing workflow that is compatible with the TAVI procedure. The techniques are designed to be fast enough to allow for real-time image fusion and visualization during the procedure, with an intra-procedural set-up requiring only a few minutes. TEE to fluoroscopy registration was achieved using a single-perspective TEE probe pose estimation technique. The alignment of CT and TEE images was achieved using custom-designed algorithms to extract aortic root contours from XPlane TEE images, and matching the shape of these contours to a CT-derived surface model. Registration accuracy was assessed on porcine and human images by identifying targets (such as guidewires or coronary ostia) on the different imaging modalities and measuring the correspondence of these targets after registration. The merged images demonstrated good visual alignment of aortic root structures, and quantitative assessment measured an accuracy of less than 1.5mm error for TEE-fluoroscopy registration and less than 6mm error for CT-TEE registration. These results suggest that the image processing techniques presented have potential for development into a clinical tool to guide TAVI. Such a tool could potentially reduce TAVI complications, reducing morbidity and mortality and allowing for a safer procedure

Continuous roadmapping in liver TACE procedures using 2D–3D catheter-based registration

PURPOSE: Fusion of pre/perioperative images and intra-operative images may add relevant information during image-guided procedures. In abdominal procedures, respiratory motion changes the position of organs, and thus accurate image guidance requires a continuous update of the spatial alignment of the (pre/perioperative) information with the organ position during the intervention. METHODS: In this paper, we propose a method to register in real time perioperative 3D rotational angiography images (3DRA) to intra-operative single-plane 2D fluoroscopic images for improved guidance in TACE interventions. The method uses the shape of 3D vessels extracted from the 3DRA and the 2D catheter shape extracted from fluoroscopy. First, the appropriate 3D vessel is selected from the complete vascular tree using a shape similarity metric. Subsequently, the catheter is registered to this vessel, and the 3DRA is visualized based on the registration results. The method is evaluated on simulated data and clinical data. RESULTS: The first selected vessel, ranked with the shape similarity metric, is used more than 39 % in the final registration and the second more than 21 %. The median of the closest corresponding points distance between 2D angiography vessels and projected 3D vessels is 4.7–5.4 mm when using the brute force optimizer and 5.2–6.6 mm when using the Powell optimizer. CONCLUSION: We present a catheter-based registration method to continuously fuse a 3DRA roadmap arterial tree onto 2D fluoroscopic images with an efficient shape similarity

FROM CONCEPT, TO DESIGN, EVALUATION AND FIRST IN VIVO DEMONSTRATION OF A TELE-OPERATED CATHETER NAVIGATION SYSTEM

Percutaneous transluminal catheter (PTC) intervention is a medical technique used to assess and treat vascular and cardiac diseases, including electrophysiological conditions. A Interventional specialists use the vasculature as a passageway to guide the catheter to the site of interest, using fluoroscopic x-ray imaging for image-guidance. Common PTC procedures include: vascular angiography, inflating balloons and stents, depositing coils, and the treatment of cardiac arrhythmia via catheter ablation. Catheter ablation has gained prevalence over the last two decades, as the treatment success rate for atrial fibrillation reaches 100%. The close proximity between the interventionalist and the radiation source combined with the increased number of procedures performed annually has lead to increased lifetime exposure; escalating the interventionalist probability of developing cancer, cataracts or passing genetic defects to offspring. Furthermore, the lead garments that protect the interventionalist can lead to musculoskeletal injury. Both these factors have lead to increased occupational risk. Catheter navigation systems are commercially available to reduce these risks. Lack of intuitive design is a common failing among these systems. iii This thesis presents the design and validation of a remote catheter navigation system (RCNS) that utilizes dexterous skills of the interventionalist during remote navigation, by keeping the catheter in their hands of the interventionalist during remote navigation. For remote catheter manipulation, the interventionalist pushes, pulls, and twists an input catheter, which is placed inside an electromechanical sensor (CS). Position changes of the input catheter are transferred to a second electromechanical (CM) that replicates the sensed motion with a second, remote catheter. Design of this system begins with understanding the dynamic forces applied to the catheter during intravascular navigation. These dynamics were quantified and then used as operating parameters in the mechanical design of the CM. In a laboratory setting, motion sensed and replicated by the RCNS was found to be 1 mm in the axial direction, 1° in the radial direction, with a latency of 180 ms. In a multi-operator, comparative study using a specially constructed multi-path vessel phantom, comparable navigation efficacy was demonstrated between the RCNS and conventional catheter manipulation, with the RCNS requiring only 9s longer to complete the same tasks. Finally, remote navigation was performed in vivo to fully demonstrate the application of this system towards the diagnosis and treatment of cardiac arrhythmia

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

FROM CONCEPT, TO DESIGN, EVALUATION AND FIRST IN VIVO DEMONSTRATION OF A TELE-OPERATED CATHETER NAVIGATION SYSTEM

Percutaneous transluminal catheter (PTC) intervention is a medical technique used to assess and treat vascular and cardiac diseases, including electrophysiological conditions. Interventional specialists use the vasculature as a passageway to guide the catheter to the site of interest, using fluoroscopic x-ray imaging for image-guidance. Common PTC procedures include: vascular angiography, inflating balloons and stents, depositing coils, and the treatment of cardiac arrhythmia via catheter ablation. Catheter ablation has gained prevalence over the last two decades, as the treatment success rate for atrial fibrillation reaches 100%. The close proximity between the interventionalist and the radiation source combined with the increased number of procedures performed annually has lead to increased lifetime exposure; escalating the interventionalist probability of developing cancer, cataracts or passing genetic defects to offspring. Furthermore, the lead garments that protect the interventionalist can lead to musculoskeletal injury. Both these factors have lead to increased occupational risk. Catheter navigation systems are commercially available to reduce these risks. Lack of intuitive design is a common failing among these systems. iii This thesis presents the design and validation of a remote catheter navigation system (RCNS) that utilizes dexterous skills of the interventionalist during remote navigation, by keeping the catheter in their hands of the interventionalist during remote navigation. For remote catheter manipulation, the interventionalist pushes, pulls, and twists an input catheter, which is placed inside an electromechanical sensor (CS). Position changes of the input catheter are transferred to a second electromechanical (CM) that replicates the sensed motion with a second, remote catheter. Design of this system begins with understanding the dynamic forces applied to the catheter during intravascular navigation. These dynamics were quantified and then used as operating parameters in the mechanical design of the CM. In a laboratory setting, motion sensed and replicated by the RCNS was found to be 1 mm in the axial direction, 1° in the radial direction, with a latency of 180 ms. In a multi-operator, comparative study using a specially constructed multi-path vessel phantom, comparable navigation efficacy was demonstrated between the RCNS and conventional catheter manipulation, with the RCNS requiring only 9s longer to complete the same tasks. Finally, remote navigation was performed in vivo to fully demonstrate the application of this system towards the diagnosis and treatment of cardiac arrhythmia

Intracardiac Ultrasound Guided Systems for Transcatheter Cardiac Interventions

Transcatheter cardiac interventions are characterized by their percutaneous nature, increased patient safety, and low hospitalization times. Transcatheter procedures involve two major stages: navigation towards the target site and the positioning of tools to deliver the therapy, during which the interventionalists face the challenge of visualizing the anatomy and the relative position of the tools such as a guidewire. Fluoroscopic and transesophageal ultrasound (TEE) imaging are the most used techniques in cardiac procedures; however, they possess the disadvantage of radiation exposure and suboptimal imaging. This work explores the potential of intracardiac ultrasound (ICE) within an image guidance system (IGS) to facilitate the two stages of cardiac interventions. First, a novel 2.5D side-firing, conical Foresight ICE probe (Conavi Medical Inc., Toronto) is characterized, calibrated, and tracked using an electromagnetic sensor. The results indicate an acceptable tracking accuracy within some limitations. Next, an IGS is developed for navigating the vessels without fluoroscopy. A forward-looking, tracked ICE probe is used to reconstruct the vessel on a phantom which mimics the ultrasound imaging of an animal vena cava. Deep learning methods are employed to segment the complex vessel geometry from ICE imaging for the first time. The ICE-reconstructed vessel showed a clinically acceptable range of accuracy. Finally, a guidance system was developed to facilitate the positioning of tools during a tricuspid valve repair. The designed system potentially facilitates the positioning of the TriClip at the coaptation gap by pre-mapping the corresponding site of regurgitation in 3D tracking space