3D Position Tracking using On-chip Magnetic Sensing in Image-guided Navigation Bronchoscopy.

This paper presents a compact and low-cost on-chip sensor and readout circuit. The sensor achieves high-resolution 5-degrees-of-freedom (DoF) tracking (x, y, z, yaw, and pitch). With the help of an external wire wound sensor, it can also achieve high-resolution 6-degrees-of-freedom (DoF) tracking (x, y, z, yaw, pitch, and roll angles). The sensor uses low-frequency magnetic fields to detect the position and orientation of instruments, providing a viable alternative to using X-rays in image-guided surgery. To measure the local magnetic field, a highly miniaturised on-chip magnetic sensor capable of sensing the magnetic field has been developed incorporating an on-chip magnetic sensor coil, analog-front end, continuous-time ΔΣ analog-to-digital converter (ADC), LVDS transmitter, bandgap reference, and voltage regulator. The microchip is fabricated using 65 nm CMOS technology and occupies an area of 1.06 mm2, the smallest reported among similar designs to the best of our knowledge. The 5-DoF system accurately navigates with a precision of 1.1 mm within the volume-of-intrest (VOI) of 15×15×15 cm3. The 6-DoF system achieves a navigation accuracy of 0.8 mm and an angular error of 1.1 degrees in the same VOI. These results were obtained at a 20 Hz update rate in benchtop characterisation. The prototype sensor demonstrates accurate position tracking in real-life pre-clinical in-vivo settings within the porcine lung of a live swine, achieving a reported worst-case registration accuracy of 5.8 mm.

Enhancing electromagnetic tracking accuracy in medical applications using pre-trained witness sensor distortion models.

PURPOSE: Electromagnetic tracking (EMT) accuracy is affected by the presence of surrounding metallic materials. In this work, we propose measuring the magnetic field's variation due to distortion at a witness position to localise the instrument causing distortion based on a pre-trained model and without additional sensors attached to it. METHODS: Two experiments were performed to demonstrate possible applications of the technique proposed. In the first case, the distortion introduced by an ultrasound (US) probe was characterised and subsequently used to track the probe position on a line. In the second application, the measurement was used to estimate the distance of an interventional fluoroscopy C-arm machine and apply the correct compensation model. RESULTS: Tracking of the US probe using the proposed method was demonstrated with millimetric accuracy. The distortion created by the C-arm caused errors in the order of centimetres, which were reduced to 1.52 mm RMS after compensation. CONCLUSIONS: The distortion profile associated with medical equipment was pre-characterised and used in applications such as object tracking and error compensation map selection. In the current study, the movement was limited to one degree of freedom (1 DOF) and simple analytical functions were used to model the magnetic distortion. Future work will explore advanced AI models to extend the method to 6 DOF tracking using multiple witness sensors.

A novel approach to wireless electromagnetic tracking using frequency modulation radio communication.

PURPOSE: Electromagnetic tracking (EMT) is beneficial in image-guided interventions to reduce the use of ionising radiation-based imaging techniques. Enabling wirelessly tracked sensors will increase the usability of these systems for catheter tracking and patient registration systems. This work introduces a novel method of wirelessly transmitting sensor data using a frequency modulation (FM) radio. METHODS: The proposed technique was tested using the open-source Anser EMT system. An electromagnetic sensor was connected in parallel to an FM transmitter prototype and wired directly to the Anser system for comparison. The performance of the FM transmitter was evaluated on a grid of 125 test points using an optical tracking system as a gold standard. RESULTS: An average position accuracy of 1.61 ± 0.68 mm and angular rotation accuracy of 0.04° for the FM transmitted sensor signal was obtained over a 30 cm × 30 cm × 30 cm volume, in comparison with the 1.14 ± 0.80 mm, 0.04° accuracy previously reported for the Anser system. The FM transmitted sensor signal had an average resolved position precision of 0.95 mm while the directly wired signal was found to have an average precision of 1.09 mm. A very low frequency (∼ 5 mHz) oscillation in the wirelessly transmitted signal was observed and compensated for by performing a dynamic scaling of the magnetic field model used for solving the sensor pose. CONCLUSIONS: We demonstrate that FM transmission of an electromagnetic sensor signal can be used to achieve similar tracking performance to a wired sensor. FM transmission for wireless EMT is a viable alternative to digital sampling and transmission over Bluetooth. Future work will create an integrated wireless sensor node using FM communication that is compatible with existing EMT systems.

Evaluating clinical near-infrared surgical camera systems with a view to optimizing operator and computational signal analysis.

Significance: As clinical evidence on the colorectal application of indocyanine green (ICG) perfusion angiography accrues, there is also interest in computerizing decision support. However, user interpretation and software development may be impacted by system factors affecting the displayed near-infrared (NIR) signal. Aim: We aim to assess the impact of camera positioning on the displayed NIR signal across different open and laparoscopic camera systems. Approach: The effects of distance, movement, and target location (center versus periphery) on the displayed fluorescence signal of different systems were measured under electromagnetic stereotactic guidance from an ICG-albumin model and in vivo during surgery. Results: Systems displayed distinct fluorescence performances with variance apparent with scope optical lens configuration (0 deg versus 30 deg), movement, target positioning, and distance. Laparoscopic system readings fitted inverse square function distance-intensity curves with one device and demonstrated a direction dependent sigmoid curve. Laparoscopic cameras presented central targets as brighter than peripheral ones, and laparoscopes with angled optical lens configurations had a diminished field of view. One handheld open system also showed a distance-intensity relationship, whereas the other maintained a consistent signal despite distance, but both presented peripheral targets brighter than central ones. Conclusions: Optimal clinical use and signal computational development requires detailed appreciation of system behaviors.

Design and pre-clinical evaluation of a folding magnetic anastomosis device for minimally invasive surgery.

Objective: This work presents the results of Benchtop tests and pre-clinical study of a novel design for a foldable magnetic anastomosis device. The device can be deployed through an endoscope device channel and fold into a ring larger than the deployment port. This new design enables the target application in JJ-anastomosis creation.Material and methods: The folding anastomosis device is constructed from a chain of permanent magnets suspended in a suture weaving inspired by the contact-aided compliant mechanisms. The device was deployed through an endoscope in Benchtop experiments and its expected coupling force was measured in a pull test. A set of experiments was executed during the pre-clinical study, where the device was deployed in the abdomen, to estimate the reliability of deployment and the plausibility of the use in jejuno-jejunal (JJ)- and gastrojejunal (GJ)-anastomosis creation.Results: The presented folding anastomosis device was shown to deploy through an endoscope device channel and a catheter with an inner diameter of 3.2 mm. After deployment the device folds reliably into a ring with an outer diameter of 7-8 mm. The folded device was shown to exhibit a coupling force comparable to similar cases of JJ-anastomosis creation. It is concluded that the presented design of a folding magnetic ring is suitable for select cases of magnetic compression anastomosis where the device is either delivered through a catheter to fold into an anastomosis ring larger than the deployment port or through an endoscopes device channel to allow for convenient visual confirmation of the device during placement.

Intraoperative compensation of magnetic field distortions for fluoroscopic and electromagnetic hybrid navigation.

PURPOSE: Hybrid navigation is a promising technique which combines the benefits of optical or electromagnetic tracking (EMT) and fluoroscopy imaging. Unfortunately, the fluoroscopy system is a source of metallic distortion for the EMT system. In this work, we present a new method for intraoperative calibration and real-time compensation of dynamic field distortions. The method was tested in the presence of a fluoroscopy C-arm, and sub-millimetre errors were obtained after distortion correction. METHODS: A hybrid navigation scenario was created by combining the open-source electromagnetic tracking system Anser EMT and a commercial fluoroscopy C-arm. The electromagnetic field generator was placed directly on top of the X-ray collimator, which introduced significant field distortion. Magnetic sensors were placed at known positions to capture the magnetic distortion, and virtual magnetic dipole sources were used to model the distortion magnetic field. The accuracy of the compensated EMT model was tested on a grid of test points. RESULTS: Error reduction was demonstrated from 12.01 to 0.35 mm and from 25.03 to 0.49 mm, for horizontal and vertical sensor orientations, respectively, over a volume of 16 × 16 × 6 cm. It is proposed that such sub-millimetre tracking errors meet the needs of most endoscopic navigation tasks. CONCLUSIONS: We describe a method to model a magnetic field in real time, based on redundant electromagnetic field measurements, and we apply it to compensate for the distortion introduced by a fluoroscopy C-arm. The main limitation of the approach is the requirement for a high number of sensors, with possible occlusion of the operative space. Solutions might come from miniaturisation and wireless sensing.

A Radiolucent Electromagnetic Tracking System for Use with Intraoperative X-ray Imaging.

In recent times, the use of electromagnetic tracking for navigation in surgery has quickly become a vital tool in minimally invasive surgery. In many procedures, electromagnetic tracking is used in tandem with X-ray technology to track a variety of tools and instruments. Most commercially available EM tracking systems can cause X-ray artifacts and attenuation due to their construction and the metals that form them. In this work, we provide a novel solution to this problem by creating a new radiolucent electromagnetic navigation system that has minimal impact on -ray imaging systems. This is a continuation of our previous work where we showed the development of the Anser open-source electromagnetic tracking system. Typical electromagnetic tracking systems operate by generating low frequency magnetic fields from coils that are located near the patient. These coils are typically made from copper, steel, and other dense radiopaque materials. In this work, we explore the use of low density aluminum to create these coils and we demonstrate that the effect on X-ray images is significantly reduced as a result of these novel changes in the materials used. The resulting field generator is shown to give at least a 60% reduction in the X-ray attenuation in comparison to our earlier designs. We verify that the system accuracy of approximately 1.5 mm RMS error is maintained with this change in design.

Planar Body-Mounted Sensors for Electromagnetic Tracking.

Electromagnetic tracking is a safe, reliable, and cost-effective method to track medical instruments in image-guided surgical navigation. However, patient motion and magnetic field distortions heavily impact the accuracy of tracked position and orientation. The use of redundant magnetic sensors can help to map and mitigate for patient movements and magnetic field distortions within the tracking region. We propose a planar inductive sensor design, printed on PCB and embedded into medical patches. The main advantage is the high repeatability and the cost benefit of using mass PCB manufacturing processes. The article presents new operative formulas for electromagnetic tracking of planar coils on the centimetre scale. The full magnetic analytical model is based on the mutual inductance between coils which can be approximated as being composed by straight conductive filaments. The full model is used to perform accurate system simulations and to assess the accuracy of faster simplified magnetic models, which are necessary to achieve real-time tracking in medical applications.

A Novel Simulated Training Platform and Study of Performance Among Different Levels of Learners in Flexible Cystoscopy.

INTRODUCTION: The aims of this study were to test a novel simulation platform suitable for flexible cystoscopy using a standard scope, to assess the platform's proposed use as a training tool for flexible cystoscopy, and to assess the user experience through surveyed response. METHODS: Thirty-one urologists (11 novices, 20 experts) were evaluated using a novel light-based bladder model and standard flexible cystoscope. Time to complete full inspection of the simulated bladder was measured, and the scope trajectory was recorded. Participants also completed a survey of the training platform. RESULTS: Thirty participants completed a simulated inspection of a portable bladder model with a mean ± SD time for 153.1 ± 76.1 seconds. One participant failed to complete. Novice urologists (defined as those having completed less than 50 flexible cystoscopies in clinic) had a mean ± SD time of 176.9 ± 95.8 seconds, whereas with experts, this decreased to 139.3 ± 60.7 seconds. Dynamic trajectory maps identified "blind spots" within each user's cystoscopy performance. In a poststudy follow-up, 27 participants considered the tool valuable or extremely valuable for training, whereas 19 participants considered that the tool either very well or excellently replicated the clinical setting. All participants ranked the tool as very good or excellent for overall quality of training. DISCUSSION: Advances in electronic technology make portable low-cost models a potential low-cost alternative to endourology training platforms. In providing a quantifiable measure of user performance, the tool may shorten the learning curve in flexible cystoscopy and, potentially, reduce clinical errors and provide quantifiable measures for further clinical training.

An open electromagnetic tracking framework applied to targeted liver tumour ablation.

PURPOSE: Electromagnetic tracking is a core platform technology in the navigation and visualisation of image-guided procedures. The technology provides high tracking accuracy in non-line-of-sight environments, allowing instrument navigation in locations where optical tracking is not feasible. EMT can be beneficial in applications such as percutaneous radiofrequency ablation for the treatment of hepatic lesions where the needle tip may be obscured due to difficult liver environments (e.g subcutaneous fat or ablation artefacts). Advances in the field of EMT include novel methods of improving tracking system accuracy, precision and error compensation capabilities, though such system-level improvements cannot be readily incorporated in current therapy applications due to the 'blackbox' nature of commercial tracking solving algorithms. METHODS: This paper defines a software framework to allow novel EMT designs, and improvements become part of the global design process for image-guided interventions. An exemplary framework is implemented in the Python programming language and demonstrated with the open-source Anser EMT system. The framework is applied in the preclinical setting though targeted liver ablation therapy on an animal model. RESULTS: The developed framework was tested with the Anser EMT electromagnetic tracking platform. Liver tumour targeting was performed using the tracking framework with the CustusX navigation platform using commercially available electromagnetically tracked needles. Ablation of two tumours was performed with a commercially available ablation system. Necropsy of the tumours indicated ablations within 5 mm of the tumours. CONCLUSIONS: An open-source framework for electromagnetic tracking was presented and effectively demonstrated in the preclinical setting. We believe that this framework provides a structure for future advancement in EMT system in and customised instrument design.

Automated Balloon Control in Resuscitative Endovascular Balloon Occlusion of the Aorta.

OBJECTIVE: The goal of this study was to demonstrate the technical feasibility of automated balloon pressure management during resuscitative endovascular balloon occlusion of the aorta (REBOA) in the pre-clinical setting. METHODS: This paper presents an intelligent balloon management device which automates the balloon inflation process, preventing the possibility of balloon over or under inflation, optimizes inflation pressure, and if indicated, deflates automating partial REBOA to allow the distal organ perfusion. Edwards TruWave pressure transducers are used to monitor the blood pressure proximal and distal to the balloon, as well as the internal balloon pressure. A faux PID controller, implemented on an Arduino platform, is used in a feedback control loop to allow a user-defined mean arterial pressure setpoint to be reached, via a syringe driver which allows intelligent inflation and deflation of the catheter balloon. RESULTS: Ex vivo testing on a vascular perfusion simulator provided the characteristic behavior of a fully occluded aorta, namely the decrease of distal pressure to zero. In vivo testing on live porcine models indicated that automated partial REBOA is achievable and by enabling partial occlusion may offer improved medical outcomes compared to the manual control. CONCLUSION: Automated balloon pressure management of endovascular occlusion is feasible and can be successfully implemented without changes on current clinical workflows. SIGNIFICANCE: With further development, automated balloon management may significantly improve clinical outcomes in REBOA.

Peripheral tumour targeting using open-source virtual bronchoscopy with electromagnetic tracking: a multi-user pre-clinical study.

Objectives: The goal was to demonstrate the utility of open-source tracking and visualisation tools in the targeting of lung cancer.Material and methods: The study demonstrates the first deployment of the Anser electromagnetic (EM) tracking system with the CustusX image-guided interventional research platform to navigate using an endobronchial catheter to injected tumour targets. Live animal investigations validated the deployment and targeting of peripheral tumour models using an innovative tumour marking routine.Results: Novel tumour model deployment was successfully achieved at all eight target sites across two live animal investigations without pneumothorax. Virtual bronchoscopy with tracking successfully guided the tracked catheter to 2-12 mm from the target tumour site. Deployment of a novel marker was achieved at all eight sites providing a reliable measure of targeting accuracy. Targeting accuracy within 10 mm was achieved in 7/8 sites and in all cases, the virtual target distance at marker deployment was within the range subsequently measured with x-ray.Conclusions: Endobronchial targeting of peripheral airway targets is feasible using existing open-source technology. Notwithstanding the shortcomings of current commercial platforms, technological improvements in EM tracking and registration accuracy fostered by open-source technology may provide the impetus for widespread clinical uptake of electromagnetic navigation in bronchoscopy.

Distorter Characterisation Using Mutual Inductance in Electromagnetic Tracking.

Electromagnetic tracking (EMT) is playing an increasingly important role in surgical navigation, medical robotics and virtual reality development as a positional and orientation reference. Though EMT is not restricted by line-of-sight requirements, measurement errors caused by magnetic distortions in the environment remain the technology's principal shortcoming. The characterisation, reduction and compensation of these errors is a broadly researched topic, with many developed techniques relying on auxiliary tracking hardware including redundant sensor arrays, optical and inertial tracking systems. This paper describes a novel method of detecting static magnetic distortions using only the magnetic field transmitting array. An existing transmitter design is modified to enable simultaneous transmission and reception of the generated magnetic field. A mutual inductance model is developed for this transmitter design in which deviations from control measurements indicate the location, magnitude and material of the field distorter to an approximate degree. While not directly compensating for errors, this work enables users of EMT systems to optimise placement of the magnetic transmitter by characterising a distorter's effect within the tracking volume without the use of additional hardware. The discrimination capabilities of this method may also allow researchers to apply material-specific compensation techniques to minimise position error in the clinical setting.

Automated Catheter Navigation With Electromagnetic Image Guidance.

This paper describes a novel method of controlling an endoscopic catheter by using an automated catheter tensioning system with the objective of providing clinicians with improved manipulation capabilities within the patient. Catheters are used in many clinical procedures to provide access to the cardiopulmonary system. Control of such catheters is performed manually by the clinicians using a handle, typically actuating a single or opposing set of pull wires. Such catheters are generally actuated in a single plane, requiring the clinician to rotate the catheter handle to navigate the system. The automation system described here allows closed-loop control of a custom bronchial catheter in tandem with an electromagnetic tracking of the catheter tip and image guidance by using a 3D Slicer. An electromechanical drive train applies tension to four pull wires to steer the catheter tip, with the applied force constantly monitored through force sensing load cells. The applied tension is controlled through a PC connected joystick. An electromagnetic sensor embedded in the catheter tip enables constant real-time position tracking, whereas a working channel provides a route for endoscopic instruments. The system is demonstrated and tested in both a breathing lung model and a preclinical animal study. Navigation to predefined targets in the subject's airways by using the joystick while using virtual image guidance and electromagnetic tracking was demonstrated. Average targeting times were 29 and 10 s, respectively, for the breathing lung and live animal studies. This paper presents the first reported remote controlled bronchial working channel catheter utilizing electromagnetic tracking and has many implications for future development in endoscopic and catheter-based procedures.

Anser EMT: the first open-source electromagnetic tracking platform for image-guided interventions.

PURPOSE: Electromagnetic tracking is the gold standard for instrument tracking and navigation in the clinical setting without line of sight. Whilst clinical platforms exist for interventional bronchoscopy and neurosurgical navigation, the limited flexibility and high costs of electromagnetic tracking (EMT) systems for research investigations mitigate against a better understanding of the technology's characterisation and limitations. The Anser project provides an open-source implementation for EMT with particular application to image-guided interventions. METHODS: This work provides implementation schematics for our previously reported EMT system which relies on low-cost acquisition and demodulation techniques using both National Instruments and Arduino hardware alongside MATLAB support code. The system performance is objectively compared to other commercial tracking platforms using the Hummel assessment protocol. RESULTS: Positional accuracy of 1.14 mm and angular rotation accuracy of [Formula: see text] are reported. Like other EMT platforms, Anser is susceptible to tracking errors due to eddy current and ferromagnetic distortion. The system is compatible with commercially available EMT sensors as well as the Open Network Interface for image-guided therapy (OpenIGTLink) for easy communication with visualisation and medical imaging toolkits such as MITK and 3D Slicer. CONCLUSIONS: By providing an open-source platform for research investigations, we believe that novel and collaborative approaches can overcome the limitations of current EMT technology.

Pre-clinical validation of virtual bronchoscopy using 3D Slicer.

PURPOSE: Lung cancer still represents the leading cause of cancer-related death, and the long-term survival rate remains low. Computed tomography (CT) is currently the most common imaging modality for lung diseases recognition. The purpose of this work was to develop a simple and easily accessible virtual bronchoscopy system to be coupled with a customized electromagnetic (EM) tracking system for navigation in the lung and which requires as little user interaction as possible, while maintaining high usability. METHODS: The proposed method has been implemented as an extension to the open-source platform, 3D Slicer. It creates a virtual reconstruction of the airways starting from CT images for virtual navigation. It provides tools for pre-procedural planning and virtual navigation, and it has been optimized for use in combination with a [Formula: see text] of freedom EM tracking sensor. Performance of the algorithm has been evaluated in ex vivo and in vivo testing. RESULTS: During ex vivo testing, nine volunteer physicians tested the implemented algorithm to navigate three separate targets placed inside a breathing pig lung model. In general, the system proved easy to use and accurate in replicating the clinical setting and seemed to help choose the correct path without any previous experience or image analysis. Two separate animal studies confirmed technical feasibility and usability of the system. CONCLUSIONS: This work describes an easily accessible virtual bronchoscopy system for navigation in the lung. The system provides the user with a complete set of tools that facilitate navigation towards user-selected regions of interest. Results from ex vivo and in vivo studies showed that the system opens the way for potential future work with virtual navigation for safe and reliable airway disease diagnosis.

Loss of flexion during bronchoscopy: a physical experiment and case study of commercially available systems.

During routine endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) procedures, especially with biopsy of lymph nodes in or around the left upper lobe, frequent reports have noted the loss of ultrasound image and needle angulation leading to an inability to biopsy nodes visualised by EBUS. The aim of this research was to investigate and compare this loss of angulation with commercially available scopes. Bench-top experiments and a clinical case study demonstrated the varying loss of scope angulation, flexibility and manoeuvrability with different scopes and biopsy instruments leading to procedural implications. Improvements in both the EBUS scope and needle characteristics are required to overcome this limitation which has implications in bronchoscope navigation and the diagnostic yield of EBUS-TBNA.

Evaluation of Endoscopically Deployed Radiopaque Tumor Models in Bronchoscopy.

BACKGROUND: Radiopaque markers and soft tissue models have been used extensively in clinical applications to target cancerous lesions and to calibrate and characterize imaging systems. However, the development of radiopaque, soft tissue models for pulmonary lesions is yet to be optimized. Such a material may improve endoscopic training techniques and also be useful to evaluate bronchoscopy navigation systems by the targeting and sampling of tumor models with computed tomography. METHODS: This study investigates a modified agarose-based model and a novel contrast-infused tripe model to create clinically relevant pulmonary tumor models. An iodine-enhanced agarose model presents an injectable solution with high image contrast under computed tomography capable of reaching distal bronchial airways. The tripe solution presents a cheap and easily deployed method to quickly establish a fiducial marker that may be used during bronchial imaging system training and evaluation. RESULTS: The iodine-enriched agarose model demonstrates desirable mechanical characteristics ex vivo, but has a number of limitations when administered in a live setting. The tripe solution presents a far more effective in vivo pulmonary tumor model and offers an effective radiopaque marker. However, the size of the tripe tumor samples required for effective insertion limits its ability to reach more distal airways. An iterative testing process was used to optimize the model composition, culminating in live animal investigations (n=3). CONCLUSION: Both contrast-infused agarose and tripe models present a promising analog to a pulmonary lesion and may act as a radiopaque marker for bronchoscopic training and biopsy evaluation.