First Ex Vivo Animal Study of a Biological Heart Valve Prosthesis Sensorized with Intravalvular Impedance

IntraValvular Impedance (IVI) sensing is an innovative concept for monitoring heart valve prostheses after implant. We recently demonstrated IVI sensing feasible in vitro for biological heart valves (BHVs). In this study, for the first time, we investigate ex vivo the IVI sensing applied to a BHV when it is surrounded by biological tissue, similar to a real implant condition. A commercial model of BHV was sensorized with three miniaturized electrodes embedded in the commissures of the valve leaflets and connected to an external impedance measurement unit. To perform ex vivo animal tests, the sensorized BHV was implanted in the aortic position of an explanted porcine heart, which was connected to a cardiac BioSimulator platform. The IVI signal was recorded in different dynamic cardiac conditions reproduced with the BioSimulator, varying the cardiac cycle rate and the stroke volume. For each condition, the maximum percent variation in the IVI signal was evaluated and compared. The IVI signal was also processed to calculate its first derivative (dIVI/dt), which should reflect the rate of the valve leaflets opening/closing. The results demonstrated that the IVI signal is well detectable when the sensorized BHV is surrounded by biological tissue, maintaining the similar increasing/decreasing trend that was found during in vitro experiments. The signal can also be informative on the rate of valve opening/closing, as indicated by the changes in dIVI/dt in different dynamic cardiac conditions

An Update of Eyeglasses-Supported Nasal–Facial Prosthetic Rehabilitation of Cancer Patients with Post-Surgical Complications: A Case Report

Featured Application: This case report aims to describe an update of the digital protocol for the fabrication of a facial prosthesis for those patients who cannot be rehabilitated with plastic surgery because of post-surgical complications after maxillofacial surgery. In detail, it describes the application of the digital protocol to a mid-facial defect. The innovation proposed is oriented to simplify the procedures and reduce the time and cost of the process, aiming to recover the quality of life of inoperable patients. This case report aims to describe novel steps in the digital design/manufacturing of facial prostheses for cancer patients with wide inoperable residual defects, with a focus on a case of a mid-facial defect. A facial scanner was used to make an impression of the post-surgical residual defect and to digitalize it. The daughter’s face scan was used for reconstructing the missing anatomy. Using 3D printing technologies, try-in prototypes were produced in silicone material. The substructure was laser melted. The final prosthesis was relined directly onto the patient’s defect. The prosthesis resulted in a very low weight and a high elasticity of the external margins. The laser-melted substructure ensured the necessary rigidity with minimum thickness

Development of a CO2 sensor for extracorporeal life support applications

Measurement of carbon dioxide (CO2) in medical applications is a well-established method for monitoring patient’s pulmonary function in a noninvasive way widely used in emergency, intensive care, and during anesthesia. Even in extracorporeal-life support applications, such as Extracorporeal Carbon Dioxide Removal (ECCO2R), Extracorporeal Membrane Oxygenation (ECMO), and cardiopulmonary by-pass (CPB), measurement of the CO2 concentration in the membrane oxygenator exhaust gas is proven to be useful to evaluate the treatment progress as well as the performance of the membrane oxygenator. In this paper, we present a new optical sensor specifically designed for the measurement of CO2 concentration in oxygenator exhaust gas. Further, the developed sensor allows measurement of the gas flow applied to the membrane oxygenator as well as the estimation of the CO2 removal rate. A heating module is implemented within the sensor to avoid water vapor condensation. Effects of temperature on the sensor optical elements of the sensors are disclosed, as well as a method to avoid signal–temperature dependency. The newly developed sensor has been tested and compared against a reference device routinely used in clinical practice in both laboratory and in vivo conditions. Results show that sensor accuracy fulfills the requirements of the ISO standard, and that is suitable for clinical applications

A novel non-invasive device for the assessment of central venous pressure in hospital, office and home

Background: Venous congestion can be quantified by central venous pressure (CVP) and its monitoring is crucial to understand and follow the hemodynamic status of patients with cardio-respiratory diseases. The standard technique for CVP measurement is invasive, requiring the insertion of a catheter into a jugular vein, with potential complications. On the other hand, the current non-invasive methods, mainly based on ultrasounds, remain operator-dependent and are unsuitable for use in the home environment. In this paper, we will introduce a novel, non-invasive device for the hospital, office and home assessment of CVP. Methods: After describing the measurement concept, we will report a preliminary experimental study enrolling 5 voluntary healthy subjects to evaluate the VenCoM measurements’ repeatability, and the system’s capability in measuring small elicited venous pressure variations (2 mmHg), as well as an induced venous hypertension within a pathological range (12÷20 mmHg). Results: The experimental measurements showed a repeatability of ±1mmHg. The VenCoM device was able to reliably detect the elicited venous pressure variations and the simulated congestive status. Discussion and Conclusion: The proposed non-invasive VenCoM device is able to provide a fast and repeatable CVP estimate, having a wide spectrum of potential clinical applications, including the monitoring of venous congestion in heart failure patients and in subjects with renal and hepatic dysfunction, as well as pulmonary hypertension (PH) that can be extended to pneumonia COVID-19 patients even after recovery. The device needs to be tested further on a large sample size of both healthy and pathological subjects, to systematically validate its reliability and impact in clinical setting

A fully automated pipeline for a robust conjunctival hyperemia estimation

Purpose: Many semi-automated and fully-automated approaches have been proposed in literature to improve the objectivity of the estimation of conjunctival hyperemia, based on image processing analysis of eyes’ photographs. The purpose is to improve its evaluation using faster fully-automated systems and independent by the human subjectivity. Methods: In this work, we introduce a fully-automated analysis of the redness grading scales able to completely automatize the clinical procedure, starting from the acquired image to the redness estimation. In particular, we introduce a neural network model for the conjunctival segmentation followed by an image processing pipeline for the vessels network segmentation. From these steps, we extract some features already known in literature and whose correlation with the conjunctival redness has already been proved. Lastly, we implemented a predictive model for the conjunctival hyperemia using these features. Results: In this work, we used a dataset of images acquired during clinical practice.We trained a neural network model for the conjunctival segmentation, obtaining an average accuracy of 0.94 and a corresponding IoU score of 0.88 on a test set of images. The set of features extracted on these ROIs is able to correctly predict the Efron scale values with a Spearman’s correlation coefficient of 0.701 on a set of not previously used samples. Conclusions: The robustness of our pipeline confirms its possible usage in a clinical practice as a viable decision support system for the ophthalmologists

Review on Augmented Reality in Oral and Cranio-Maxillofacial Surgery: Toward 'Surgery-Specific' Head-Up Displays

In recent years, there has been an increasing interest towards the augmented reality as applied to the surgical field. We conducted a systematic review of literature classifying the augmented reality applications in oral and cranio-maxillofacial surgery (OCMS) in order to pave the way to future solutions that may ease the adoption of AR guidance in surgical practice. Publications containing the terms 'augmented reality' AND 'maxillofacial surgery', and the terms 'augmented reality' AND 'oral surgery' were searched in the PubMed database. Through the selected studies, we performed a preliminary breakdown according to general aspects, such as surgical subspecialty, year of publication and country of research; then, a more specific breakdown was provided according to technical features of AR-based devices, such as virtual data source, visualization processing mode, tracking mode, registration technique and AR display type. The systematic search identified 30 eligible publications. Most studies (14) were in orthognatic surgery, the minority (2) concerned traumatology, while 6 studies were in oncology and 8 in general OCMS. In 8 of 30 studies the AR systems were based on a head-mounted approach using smart glasses or headsets. In most of these cases (7), a video-see-through mode was implemented, while only 1 study described an optical-see-through mode. In the remaining 22 studies, the AR content was displayed on 2D displays (10), full-parallax 3D displays (6) and projectors (5). In 1 case the AR display type is not specified. AR applications are of increasing interest and adoption in oral and cranio-maxillofacial surgery, however, the quality of the AR experience represents the key requisite for a successful result. Widespread use of AR systems in the operating room may be encouraged by the availability of 'surgery-specific' head-mounted devices that should guarantee the accuracy required for surgical tasks and the optimal ergonomics

Wearable augmented reality platform for aiding complex 3D trajectory tracing

Augmented reality (AR) Head-Mounted Displays (HMDs) are emerging as the most efficient output medium to support manual tasks performed under direct vision. Despite that, technological and human-factor limitations still hinder their routine use for aiding high-precision manual tasks in the peripersonal space. To overcome such limitations, in this work, we show the results of a user study aimed to validate qualitatively and quantitatively a recently developed AR platform specifically conceived for guiding complex 3D trajectory tracing tasks. The AR platform comprises a new-concept AR video see-through (VST) HMD and a dedicated software framework for the effective deployment of the AR application. In the experiments, the subjects were asked to perform 3D trajectory tracing tasks on 3D-printed replica of planar structures or more elaborated bony anatomies. The accuracy of the trajectories traced by the subjects was evaluated by using templates designed ad hoc to match the surface of the phantoms. The quantitative results suggest that the AR platform could be used to guide high-precision tasks: on average more than 94% of the traced trajectories stayed within an error margin lower than 1 mm. The results confirm that the proposed AR platform will boost the profitable adoption of AR HMDs to guide high precision manual tasks in the peripersonal space

Comparison of Bone Segmentation Software over Different Anatomical Parts

Three-dimensional bone shape reconstruction is a fundamental step for any subject-specific musculo-skeletal model. Typically, medical images are processed to reconstruct bone surfaces via slice-by-slice contour identification. Freeware software packages are available, but commercial ones must be used for the necessary certification in clinics. The commercial software packages also imply expensive hardware and demanding training, but offer valuable tools. The aim of the present work is to report the performance of five commercial software packages (Mimics®, Amira™, D2P™, Simpleware™, and Segment 3D Print™), particularly the time to import and to create the model, the number of triangles of the mesh, and the STL file size. DICOM files of three different computed tomography scans from five different human anatomical areas were utilized for bone shape reconstruction by using each of these packages. The same operator and the same hosting hardware were used for these analyses. The computational time was found to be different between the packages analyzed, probably because of the pre-processing implied in this operation. The longer “time-to-import” observed in one software is likely due to the volume rendering during uploading. A similar number of triangles per megabyte (approximately 20 thousand) was observed for the five commercial packages. The present work showed the good performance of these software packages, with the main features being better than those analyzed previously in freeware packages

AEducaAR, Anatomical Education in Augmented Reality: A Pilot Experience of an Innovative Educational Tool Combining AR Technology and 3D Printing

Gross anatomy knowledge is an essential element for medical students in their education, and nowadays, cadaver-based instruction represents the main instructional tool able to provide three-dimensional (3D) and topographical comprehensions. The aim of the study was to develop and test a prototype of an innovative tool for medical education in human anatomy based on the combination of augmented reality (AR) technology and a tangible 3D printed model that can be explored and manipulated by trainees, thus favoring a three-dimensional and topographical learning approach. After development of the tool, called AEducaAR (Anatomical Education with Augmented Reality), it was tested and evaluated by 62 second-year degree medical students attending the human anatomy course at the International School of Medicine and Surgery of the University of Bologna. Students were divided into two groups: AEducaAR-based learning (“AEducaAR group”) was compared to standard learning using human anatomy atlas (“Control group”). Both groups performed an objective test and an anonymous questionnaire. In the objective test, the results showed no significant difference between the two learning methods; instead, in the questionnaire, students showed enthusiasm and interest for the new tool and highlighted its training potentiality in open-ended comments. Therefore, the presented AEducaAR tool, once implemented, may contribute to enhancing students’ motivation for learning, increasing long-term memory retention and 3D comprehension of anatomical structures. Moreover, this new tool might help medical students to approach to innovative medical devices and technologies useful in their future careers

Validation of a patient-specific system for mandible-first bimaxillary surgery: ramus and implant positioning precision assessment and guide design comparison

In orthognathic surgery, the use of patient-specific osteosynthesis devices is a novel approach used to transfer the virtual surgical plan to the patient. The aim of this study is to analyse the quality of mandibular anatomy reproduction using a mandible-first mandibular-PSI guided procedure on 22 patients. Three different positioning guide designs were compared in terms of osteosynthesis plate positioning and mandibular anatomical outcome. PSIs and positioning guides were designed according to virtual surgical plan and 3D printed using biocompatible materials. A CBCT scan was performed 1 month after surgery and postoperative mandibular models were segmented for comparison against the surgical plan. A precision comparison was carried out among the three groups. Correlations between obtained rami and plates discrepancies and between planned rami displacements and obtained rami discrepancies were calculated. Intraoperatively, all PSIs were successfully applied. The procedure was found to be accurate in planned mandibular anatomy reproduction. Different guide designs did not differ in mandibular outcome precision. Plate positional discrepancies influenced the corresponding ramus position, mainly in roll angle and vertical translation. Ramus planned displacement was found to be a further potential source of inaccuracy, possibly due to osteosynthesis surface interference