A novel clip-on device for electromagnetic tracking in endobronchial ultrasound bronchoscopy.

INTRODUCTION: The established method for assessment of mediastinal and hilar lymph nodes is endobronchial ultrasound bronchoscopy (EBUS) with needle aspirations. Previously, we presented an electromagnetic navigation platform for this purpose. There were several issues with the permanent electromagnetic tracking (EMT) sensor attachment on the tip of the experimental EBUS bronchoscope. The purpose was to develop a device for on-site attachment of the EMT sensor. MATERIAL AND METHODS: A clip-on EMT sensor attachment device was 3D-printed in Ultem™ and attached to an EBUS bronchoscope. A specially designed ultrasound probe calibration adapter was developed for on-site and quick probe calibration. Navigation accuracy was studied using a wire cross water phantom and clinical feasibility was tested in a healthy volunteer. RESULTS: The device attached to the EBUS bronchoscope increased its diameter from 6.9 mm to 9.5 mm. Average preclinical navigation accuracy was 3.9 mm after adapter calibration. The maneuvering of the bronchoscope examining a healthy volunteer was adequate without harming the respiratory epithelium, and the device stayed firmly attached. CONCLUSION: Development, calibration and testing of a clip-on EMT sensor attachment device for EBUS bronchoscopy was successfully demonstrated. Acceptable accuracy results were obtained, and the device is ready to be tested in patient studies.

A new visualization method for navigated bronchoscopy.

OBJECTIVE: In flexible endoscopy techniques, such as bronchoscopy, there is often a challenge visualizing the path from start to target based on preoperative data and accessing these during the procedure. An example of this is visualizing only the inside of central airways in bronchoscopy. Virtual bronchoscopy (VB) does not meet the pulmonologist's need to detect, define and sample the frequent targets outside the bronchial wall. Our aim was to develop and study a new visualization technique for navigated bronchoscopy. MATERIAL AND METHODS: We extracted the shortest possible path from the top of the trachea to the target along the airway centerline and a corresponding auxiliary route in the opposite lung. A surface structure between the centerlines was developed and displayed. The new technique was tested on non-selective CT data from eight patients using artificial lung targets. RESULTS: The new display technique anchored to centerline curved surface (ACCuSurf) made it easy to detect and interpret anatomical features, targets and neighboring anatomy outside the airways, in all eight patients. CONCLUSIONS: ACCuSurf can simplify planning and performing navigated bronchoscopy, meets the challenge of improving orientation and register the direction of the moving endoscope, thus creating an optimal visualization for navigated bronchoscopy.

COPD and microalbuminuria: a 12-year follow-up study.

Chronic obstructive pulmonary disease (COPD), low lung function independent of diagnosis and markers of inflammation are all associated with increased morbidity and mortality. Microalbuminuria, reflecting endothelial dysfunction, could be a relevant inflammatory marker of potential systemic effects of COPD. We hypothesised that there was a positive association between microalbuminuria and mortality in individuals with COPD. We conducted a 12-year follow-up study of 3129 participants in the second survey of the Nord-Trøndelag Health Study (HUNT), Norway. At baseline, albuminuria was analysed in three urine samples and spirometry was performed. Among the participants, 136 had COPD and microalbuminuria, defined as a urinary albumin/creatinine ratio between 2.5 and 30.0 mg·mmol(-1). The main outcome measures were hazard ratio of all-cause mortality according to microalbuminuria. Compared to those with COPD without microalbuminuria, the adjusted hazard ratio for all-cause mortality in those with COPD and microalbuminuria was 1.54, 95% CI 1.16-2.04. This result was similar after excluding cardiovascular disease at baseline. Classifying COPD severity by Global Initiative for Chronic Obstructive Lung Disease, there was a positive association trend with increasing severity stages. Microalbuminuria is associated with all-cause mortality in individuals with COPD and could be a relevant tool in identification of patients with poor prognosis.

Macro-indentation testing of soft biological materials and assessment of hyper-elastic material models from inverse finite element analysis.

Mechanical characterization of hydrogels and ultra-soft tissues is a challenging task both from an experimental and material parameter estimation perspective because they are much softer than many biological materials, ceramics, or polymers. The elastic modulus of such materials is within the 1 - 100 kPa range, behaving as a hyperelastic solid with strain hardening capability at large strains. In the current study, indentation experiments have been performed on agarose hydrogels, bovine liver, and bovine lymph node specimens. This work reports on the reliable determination of the elastic modulus by indentation experiments carried out at the macro-scale (mm) using a spherical indenter. However, parameter identification of the hyperelastic material properties usually requires an inverse finite element analysis due to the lack of an analytical contact model of the indentation test. Hence a comprehensive study on the spherical indentation of hyperelastic soft materials is carried out through robust computational analysis. Neo-Hookean and first-order Ogden hyperelastic material models were found to be most suitable. A case study on known anisotropic hyperelastic material showed the inability of the inverse finite element method to uniquely identify the whole material parameter set.

A multimodal image guiding system for Navigated Ultrasound Bronchoscopy (EBUS): A human feasibility study.

BACKGROUND: Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is the endoscopic method of choice for confirming lung cancer metastasis to mediastinal lymph nodes. Precision is crucial for correct staging and clinical decision-making. Navigation and multimodal imaging can potentially improve EBUS-TBNA efficiency. AIMS: To demonstrate the feasibility of a multimodal image guiding system using electromagnetic navigation for ultrasound bronchoschopy in humans. METHODS: Four patients referred for lung cancer diagnosis and staging with EBUS-TBNA were enrolled in the study. Target lymph nodes were predefined from the preoperative computed tomography (CT) images. A prototype convex probe ultrasound bronchoscope with an attached sensor for position tracking was used for EBUS-TBNA. Electromagnetic tracking of the ultrasound bronchoscope and ultrasound images allowed fusion of preoperative CT and intraoperative ultrasound in the navigation software. Navigated EBUS-TBNA was used to guide target lymph node localization and sampling. Navigation system accuracy was calculated, measured by the deviation between lymph node position in ultrasound and CT in three planes. Procedure time, diagnostic yield and adverse events were recorded. RESULTS: Preoperative CT and real-time ultrasound images were successfully fused and displayed in the navigation software during the procedures. Overall navigation accuracy (11 measurements) was 10.0 ± 3.8 mm, maximum 17.6 mm, minimum 4.5 mm. An adequate sample was obtained in 6/6 (100%) of targeted lymph nodes. No adverse events were registered. CONCLUSIONS: Electromagnetic navigated EBUS-TBNA was feasible, safe and easy in this human pilot study. The clinical usefulness was clearly demonstrated. Fusion of real-time ultrasound, preoperative CT and electromagnetic navigational bronchoscopy provided a controlled guiding to level of target, intraoperative overview and procedure documentation.

Intraoperative localized constrained registration in navigated bronchoscopy.

PURPOSE: One of the major challenges in electromagnetic navigated bronchoscopy is the navigation accuracy. An initial rigid image-to-patient registration may not be optimal for the entire lung volume, as the lung tissue anatomy is likely to have shifted since the time of computer tomography (CT) acquisition. The accuracy of the initial rigid registration will also be affected throughout the procedure by breathing, coughing, patient movement and tissue displacements due to pressure from bronchoscopy tools. A method to minimize the negative impact from these factors by updating the registration locally during the procedure is needed and suggested in this paper. METHODS: The intraoperative local registration method updates the initial registration by optimization in an area of special interest, for example, close to a biopsy position. The local registration was developed through an adaptation of a previously published registration method used for the initial registration of CT to the patient anatomy. The method was tested in an experimental breathing phantom setup, where respiratory movements were induced by a robotic arm. Deformations were also applied to the phantom to see if the local registration could compensate for these. RESULTS: The local registration was successfully applied in all 15 repetitions, five in each of the three parts of the airway phantom. The mean registration accuracy was improved from 11.8-19.4 mm to 4.0-6.7 mm, varying to some degree in the different segments of the airway model. CONCLUSIONS: A local registration method, to update and improve the initial image-to patient registration during navigated bronchoscopy, was developed. The method was successfully tested in a breathing phantom setup. Further development is needed to make the method more automatic. It must also be verified in human studies.

A novel platform for electromagnetic navigated ultrasound bronchoscopy (EBUS).

PURPOSE: Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) of mediastinal lymph nodes is essential for lung cancer staging and distinction between curative and palliative treatment. Precise sampling is crucial. Navigation and multimodal imaging may improve the efficiency of EBUS-TBNA. We demonstrate a novel EBUS-TBNA navigation system in a dedicated airway phantom. METHODS: Using a convex probe EBUS bronchoscope (CP-EBUS) with an integrated sensor for electromagnetic (EM) position tracking, we performed navigated CP-EBUS in a phantom. Preoperative computed tomography (CT) and real-time ultrasound (US) images were integrated into a navigation platform for EM navigated bronchoscopy. The coordinates of targets in CT and US volumes were registered in the navigation system, and the position deviation was calculated. RESULTS: The system visualized all tumor models and displayed their fused CT and US images in correct positions in the navigation system. Navigating the EBUS bronchoscope was fast and easy. Mean error observed between US and CT positions for 11 target lesions (37 measurements) was [Formula: see text] mm, maximum error was 5.9 mm. CONCLUSION: The feasibility of our novel navigated CP-EBUS system was successfully demonstrated. An EBUS navigation system is needed to meet future requirements of precise mediastinal lymph node mapping, and provides new opportunities for procedure documentation in EBUS-TBNA.

Airway Segmentation and Centerline Extraction from Thoracic CT - Comparison of a New Method to State of the Art Commercialized Methods.

INTRODUCTION: Our motivation is increased bronchoscopic diagnostic yield and optimized preparation, for navigated bronchoscopy. In navigated bronchoscopy, virtual 3D airway visualization is often used to guide a bronchoscopic tool to peripheral lesions, synchronized with the real time video bronchoscopy. Visualization during navigated bronchoscopy, the segmentation time and methods, differs. Time consumption and logistics are two essential aspects that need to be optimized when integrating such technologies in the interventional room. We compared three different approaches to obtain airway centerlines and surface. METHOD: CT lung dataset of 17 patients were processed in Mimics (Materialize, Leuven, Belgium), which provides a Basic module and a Pulmonology module (beta version) (MPM), OsiriX (Pixmeo, Geneva, Switzerland) and our Tube Segmentation Framework (TSF) method. Both MPM and TSF were evaluated with reference segmentation. Automatic and manual settings allowed us to segment the airways and obtain 3D models as well as the centrelines in all datasets. We compared the different procedures by user interactions such as number of clicks needed to process the data and quantitative measures concerning the quality of the segmentation and centrelines such as total length of the branches, number of branches, number of generations, and volume of the 3D model. RESULTS: The TSF method was the most automatic, while the Mimics Pulmonology Module (MPM) and the Mimics Basic Module (MBM) resulted in the highest number of branches. MPM is the software which demands the least number of clicks to process the data. We found that the freely available OsiriX was less accurate compared to the other methods regarding segmentation results. However, the TSF method provided results fastest regarding number of clicks. The MPM was able to find the highest number of branches and generations. On the other hand, the TSF is fully automatic and it provides the user with both segmentation of the airways and the centerlines. Reference segmentation comparison averages and standard deviations for MPM and TSF correspond to literature. CONCLUSION: The TSF is able to segment the airways and extract the centerlines in one single step. The number of branches found is lower for the TSF method than in Mimics. OsiriX demands the highest number of clicks to process the data, the segmentation is often sparse and extracting the centerline requires the use of another software system. Two of the software systems performed satisfactory with respect to be used in preprocessing CT images for navigated bronchoscopy, i.e. the TSF method and the MPM. According to reference segmentation both TSF and MPM are comparable with other segmentation methods. The level of automaticity and the resulting high number of branches plus the fact that both centerline and the surface of the airways were extracted, are requirements we considered particularly important. The in house method has the advantage of being an integrated part of a navigation platform for bronchoscopy, whilst the other methods can be considered preprocessing tools to a navigation system.

Automatic registration of CT images to patient during the initial phase of bronchoscopy: a clinical pilot study.

PURPOSE: Electromagnetic based navigated bronchoscopy using preoperative CT images has reached the clinic during the last decade. One of the challenges is the "CT to patient anatomy alignment" of the CT images acquired days or even weeks ahead of bronchoscopy. An automatic registration method, without manual registration of anatomical landmarks, was developed, implemented, and evaluated in the current study. METHODS: The registration method aligns automatically the preoperative CT images to the patient's anatomy during the initial part of the bronchoscopy. The algorithm is a modified version of an iterative closest point algorithm, which in addition to the positions also utilizes the orientation of the bronchoscope and the running direction of the CT centerline. The method was evaluated both by model-based simulated bronchoscopies and by clinical data from six real bronchoscopies. In the clinical evaluation, an electromagnetic position sensor was placed temporarily in the working channel close to the tip of a conventional bronchoscope. Position data, which were acquired while the bronchoscope was moving inside the airways, were registered to the centerline extracted from the airways in the CT image. RESULTS: A mean registration accuracy of 3.0 ± 1.4 mm was found when simulating bronchoscopies. In the clinical part of the study, the registration method was successfully applied to the data from all six patients. The positions of the bronchoscope tip aligned to the CT centerline with a mean distance range 4.7-6.5 mm. CONCLUSIONS: The authors have developed and evaluated an automatic registration algorithm for electromagnetic navigated bronchoscopy. It functioned to its purpose and did not affect the workflow for the bronchoscopic investigation of the six patients included in the study.

Navigated bronchoscopy: a technical review.

BACKGROUND: Navigated bronchoscopy uses virtual 3-dimensional lung model visualizations created from preoperative computed tomography images often in synchronization with the video bronchoscope to guide a tool to peripheral lesions. Navigated bronchoscopy has developed fast since the introduction of virtual bronchoscopy with integrated electromagnetic sensors in the late 1990s. The purposes of the review are to give an overview and update of the technological components of navigated bronchoscopy, an assessment of its clinical usefulness, and a brief assessment of the commercial platforms for navigated bronchoscopy. METHODS: We performed a literature search with relevant keywords to navigation and bronchoscopy and iterated on the reference lists of relevant papers, with emphasis on the last 5 years. RESULTS: The paper presents an overview of the components necessary for performing navigated bronchoscopy, assessment of the diagnostic accuracy of different approaches, and an analysis of the commercial systems. We were able to identify 4 commercial platforms and 9 research and development groups with considerable activity in the field. Finally, on the basis of our findings and our own experience, we provide a discussion on navigated bronchoscopy with focus on the next steps of development. CONCLUSIONS: The literature review showed that the peripheral diagnostic accuracy has improved using navigated bronchoscopy compared with traditional bronchoscopy. We believe that there is room for improvement in the diagnostic success rate by further refinement of methods, approaches, and tools used in navigated bronchoscopy.

Bronchoscope-induced displacement of lung targets: first in vivo demonstration of effect from wedging maneuver in navigated bronchoscopy.

BACKGROUND: The accuracy of navigated bronchoscopy relies on a best possible correlation between the preoperative computed tomography images used for planning and the actual tumor position during bronchoscopy. Change in lung structure during the procedure may reduce success rate. The size of the lung changes during breathing, which may be predicted and at least partly compensated by a navigation system. We have studied the effect of the bronchoscopy itself, to see if and how the procedure causes further distortions, which might be harder to predict and compensate. METHODS: Using newly developed lung tracking sensors, we have measured the movement of individual lung segments during a bronchoscopy session in pigs. The bronchoscope was moved stepwise forward, ending in a wedge position, where it is often positioned when collecting peripheral biopsy specimens during conventional bronchoscopy. RESULTS: The influence of the bronchoscope on lung segment movement was minimal while positioned in the trachea, main bronchus, or lobe bronchus. However, in the wedge position, it displaced the lung targets and reduced the natural respiratory motion. CONCLUSIONS: A bronchoscope placed in a wedge position displaces lung targets and affects their respiratory behavior. As an image navigation system guides the operator towards a position dictated by the preoperative computed tomography, the displacement found in this study may cause the operator to miss the target. This may be part of the explanation for the limited success rates reported in the literature for navigated bronchoscopy.