Methods for medical applications

This paper deals with additive manufacturing techniques for the creation of 3D fetal face models starting from routine 3D ultrasound data. In particular, two distinct themes are addressed. First, a method for processing and building 3D models based on the use of medical image processing techniques is proposed. Second, the preliminary results of a questionnaire distributed to future parents consider the use of these reconstructions both from an emotional and an affective point of view. In particular, the study focuses on the enhancement of the perception of maternity or paternity and the improvement in the relationship between parents and physicians in case of fetal malformations, in particular facial or cleft lip diseases.

For the purpose of reducing uncertainties in the measurements of morphologically complex biological objects, the authors present a new automatic method, which takes advantage from the representation of the object in the form of the 3D geometric model obtained from CT-scans or 3D scanning. In this paper, the method is verified in real cases and compared with the traditional approaches.

Keywords: 3D biomedical image analysis , measurement accuracy , measurement protocols in biomedicine , shape segmentation

This work explores the use of an industry-oriented digital human modelling tool for the estimation of the musculoskeletal loads corresponding to a simulated human activity. The error in using a static analysis tool for measuring articulations loads under not-static conditions is assessed with reference to an accurate dynamic model and data from real experiments. Results show that, for slow movements, static analysis tools provide good approximation of the actual loads affecting human musculoskeletal system during walking.

Keywords: Biomechanics , Dynamics , Gait analysis , Kinematics , Virtual simulation

The improvement and the massive diffusion of additive manufacturing (AM) techniques have fostered the research of design methods to exploit at best the feature introduced by these solutions. The whole design paradigm needs to be changed taking into account new manufacturing capabilities. AM is not only an innovative method of fabrication, but it requires a new way to design products. Traditional practices of mechanical design are changing to exploit all potential of AM, new parameters and geometries could be realized avoiding technologies constrains of molding or machine tooling. The concept of "manufacturing for design" increasingly acquires greater importance and this means we have the chance to focus almost entirely on product functionality. The possibility to confer inhomogeneous properties to objects provides an important design key. We will study behavior and structure according to desired functions for each object identifying three main aspects to vary: infill type, external topology and shape, and material composition. In this research work, we focus on fused deposition modeling (FDM) technology of three dimensional (3D) printing that easily allows to explore all previous conditions. We present a new way to conceive design process in order to confer variable properties to AM objects and some guidelines to control properties of deformation and elasticity using classic infills. The ultimate aim is to apply new design rules provided by AM in the prosthetic field of lower limb amputees. The socket of the prosthesis represents a deformable interface between the residual limb and the artificial leg that must be optimized according to geometry and loads distribution of patient. An application for a transfemoral patient will be discussed.

This paper concerns the design and manufacture of medical devices, such as lower limb prosthesis, integrating low cost industrial technologies. In particular, it focuses the attention on the custom-fit component of a lower limb prosthesis, i.e., the socket, that is the interface with the residual limb. The considered process starts from the 3D reconstruction of patients' limb and ends with the manufacture of the socket with a 3D printer using a multi-material approach. The process counts three steps: 3D modeling, testing (both experimental and numer-ical) and manufacturing. For each step adopted solutions and tools are described. Finally, conclusions are drawn mainly concerning the challenge of multi-material 3D printing of the socket.

Keywords: 3D printing , Lower limb prosthesis , Socket Modelling Assistant

Additive Manufacturing (AM) is not only an innovative approach of fabrication but it fosters a new paradigm to design products. The possibility to confer inhomogeneous properties to the product provides an important design key. This paper concerns the design and manufacture of medical devices that require a high level of customization. We focus the attention on lower limb prosthesis and in particular on the prosthetic socket. The proposed method is centered on the virtual modeling of patient's residual limb and the virtual process is highly integrated and the data flow is as fluid as possible. Three main phases can be identified: design, validation and manufacture of the socket. Firstly, the technician uses the Socket Modeling Assistant (SMA) tool to design the socket shape. Then, a numerical simulation is run to check pressure distribution and validate the socket shape. Finally, a multi-material 3D printer is used to build the socket. Preliminary results are presented and conclusions are drawn concerning the challenge of multimaterial 3D printing of the socket.

The way a person moves, either in a plain walk or performing a specific task, tells a huge quantity of information about his/her physical and, eventually, neurologic condition. A large part of a physiotherapist work of assessment is based on the qualitative evaluation, mainly visual, of a person's movements, in terms of balance, speed, control, force and other parameters. This research work aims at providing personnel involved in the rehab process with a quantitative method to assess the way movements are performed. A numerical measure of the performance, actually, allows easier and more precise assessment, eliminating bias due to subjectivity. To accomplish this goal two steps are required: 3D acquisition of the movement using a Motion Capture (Mocap) system, and analysis of collected data to extract or elaborate the final outcome in the form requested by the medical staff. The paper shows the way Mocap acquisition are performed and data are analyzed in the application with people having a complete spinal cord injury and using a wheelchair. The method has been tested with eight volunteers in the rehabilitation department of the Hospital Papa Giovanni XXIII in Bergamo, Italy.

Clear thermoplastic aligners are nowadays widely used in orthodontics for the correction of malocclusion or teeth misalignment defects. The treatment is virtually designed with a planning software that allows for a definition of a sequence of little movement steps from the initial tooth position to the final desired one. Every single step is transformed into a physical device, the aligner, by the use of a 3D printed model on which a thin foil of plastic material is thermoformed. Manufactured aligners could have inherent limitations such as dimensional instability, low strength, and poor wear resistance. These issues could be associated with material characteristics and/or with the manufacturing processes. The present work aims at the characterization of the manufactured orthodontic devices. Firstly, mechanical properties of different materials have been assessed through a set of tensile tests under different experimental conditions. The tests have the purpose of analyzing the effect that the forming process a d the normal use of the aligner may have on mechanical properties of the material. The manufacturing process could also introduce unexpected limitations in the resulting aligners. This would be a critical element to control in order to establish resulting forces on teeth. Several studies show that resulting forces could be greatly influenced by the aligner thickness. A method to easily measure the actual thickness of the manufactured aligner is proposed. The analysis of a number of real cases shows as the thickness is far to be uniform and could vary strongly along the surface of the tooth.

Keywords: 3D Human Modeling , Clear Aligner , Mechanical Properties Assessment , Optical 3D Scanner , Thermoforming Process , Virtual Design

Orthodontic treatments based on removable thermoplastic aligners are becoming quite common in clinical practice. However, there is no technical literature explaining how the loads are transferred from the thermoformed aligner to the patient dentition. Moreover, the role of auxiliary elements used in combination with the aligner, such as attachments and divots, still needs to be thoroughly explained. This paper is focused on the development of a Finite Element (FE) model to be used in the design process of shape attributes of orthodontic aligners. Geometrical models of a maxillary dental arch, including crown and root shapes, were created by combining optical scanning and Cone Beam Computed Tomography (CBCT). Finite Element Analysis (FEA) was used to compare five different aligner's configurations for the same tooth orthodontic tipping movement (rotation around the tooth's center of resistance). The different scenarios were analyzed by comparing the moment along the mesio-distal direction of the tooth and the resulting moment-to-force ratio (M:F) delivered to the tooth on the plane of interest. Results evidenced the influence of the aligner's configuration on the effectiveness of the planned orthodontic movement.

Keywords: Anatomical modelling , Numerical analysis , Orthodontic aligner , Orthodontic tooth movement

In the present work, the effect of Eruption Guidance Appliances (EGAs) on TemporoMandibular Joint (TMJ) disks stress level is studied. EGAs are orthodontic appliances used for early orthodontic treatments in order to prevent malocclusion problems. Commercially available EGAs are usually produced by using standard sizes. For this reason, they are not able to meet all the specific needs of each patient. In particular, EGAs are symmetric devices, while patient arches generally present asymmetric conditions. Thus, uneven stress levels may occur in TMJ disks, causing comfort reduction and potential damage to the most solicited disk. On the other hand, a customized EGA could overcome these issues, improving the treatment effectiveness. In this preliminary study, a Finite Element (FE) model was developed to investigate the effects of a symmetric EGA when applied to an asymmetric mouth. Different misalignment conditions were studied to compare the TMJ disks stress levels and to analyze the limitations of a symmetric EGA. The developed FE model can be used to design patient-specific EGAs, which could be manufactured by exploiting non-conventional techniques such as 3D printing.

Keywords: Eruption guidance appliance (EGA) , FE model , Patient-specific orthodontic appliance , TMJ disks stress , TMJ disorders

3D body scanners are nowadays used in a range of applications spanning from health, fashion and fitness to reverse engineering applications for robotics and computer vision. Nowadays very good performances are achievable when using commercial 3D body scanners; however, focusing on relative complex shape of some body details, the results still lack precision and acceptable accuracy. Such critical issue remains unsolved also when dealing with the instantaneous acquisition of the hand-wrist-arm (HWA) anatomy. In this paper, we present a new approach that leverages the emerging 3D depth cameras technologies to design a compact low cost 3D dedicated HWA scanner system capable of delivering almost instantaneous full 3D measurement.

Keywords: 3D body scanner , 3D surface , calibration , depth sensors , hand-wrist-arm anatomy

Cardiovascular diagnosis, surgical planning and intervention are among the most interested in recent developments in the field of 3D acquisition, modelling and rapid prototyping techniques. In case of complex heart disease, to provide an accurate planning of the intervention and to support surgical planning and intervention, an increasing number of Hospitals make use of physical 3D models of the cardiac structure, including heart, obtained using additive manufacturing starting from the 3D model retrieved with medical imagery. The present work aims in providing an overview on most recent approaches and methodologies for creating physical prototypes of patient-specific heart and cardiac structures, with particular reference to most critical phases such as segmentation and aspects concerning converting digital models into physical replicas through rapid prototyping techniques. First, recent techniques for image enhancement to highlight anatomical structures of interest are presented together with the current state of the art of semi-automatic image segmentation. Then, most suitable techniques for prototyping the retrieved 3D model are investigated so as to draft some hints for creating prototypes useful for planning the medical intervention.

Keywords: 3D modelling , 3D printing , Cardiovascular diseases , Heart , Medical imagery , Rapid prototyping , Surgical planning

In orthopaedics, cellular structures can be used as three-dimensional porous biomaterials that try to mimic the characteristics and function of the bone. The progress in manufacturing techniques, mainly in the field of additive manufacturing, can potentially allow the production of highly controlled pore architectures and customized implants that, however, need more sophisticated design methodologies. In this paper, the design of porous biocompatible structures based on mathematically defined surfaces (triply periodic minimal surfaces) has been considered in respect of the approach that considers unit cells entirely modelled in CAD environment. Two types of unit cell have been here considered: the cubic and the P-cell. The cubic cell is created by a 3D CAD s/w from solid features that are combined together. The P-cell is modelled using an implicit function to describe the outer surface of the cell. Two are the design parameters of the P-cell: thickness and radius. The variation of these parameters allows modifying the architecture of the basic unit of the scaffold. The modification of the radius is carried out by a procedure, based on scaling and truncation operations. The thickness of the cell is modified by thickening and closure operations on the P-isosurface. The effect of these variations on the mechanical behaviour of the scaffold has been numerically evaluated by the estimation of the stiffness of each structure considered. The results demonstrated the huge potentiality of the method and stiffness values compatible with those required for biomechanical applications.

Keywords: Bone implants , Design , Porous materials , Scaffolds

This work concerns the growing interest in accessible tourism and describes the early stages of development of Gölem project. In particular, it takes into account accompanying activities of disabled people in mountain areas. Although literature and market analysis highlight the presence of different technical solutions used for the movement of disabled persons on rough terrains, there are only a couple of solutions based on the help of guides: Joëlette© and TrailRider©. Even if the use of these devices is generally satisfactory, our analysis has highlighted the presence of some limitations such as the difficulty of maintaining the lateral balance of the devices (which involves a considerable physical effort for the guides) and their reduced comfort for the passenger. This article describes the activities developed within the Gölem project. Its main goals are to design and to test an improved model of trekking/hiking wheelchair taking into account passengers comfort and better functionality of the device. At this moment, the design and modeling phases with the definition of dynamic parameters and of the suspension system of the device have been completed. The prototype implementation phase is in progress. Future activities will provide validation and field testing of the new solution with users.

Keywords: Accessible tourism , Comfort design , Disabled people , Mountain , Suspension system design , Trekking/hiking wheelchair

In the rehabilitation field, the use of additive manufacturing techniques to realize customized orthoses is increasingly widespread. Obtaining a 3D model for the 3D printing phase can be done following different methodologies. We consider the creation of personalized upper limb orthoses, also including fingers, starting from the acquisition of the hand geometry through accurate 3D scanning. However, hand scanning procedure presents differences between healthy subjects and patients affected by pathologies that compromise upper limb functionality. In this work, we present the concept and design of a 3D printed support to assist hand scanning of such patients. The device, realized with FDM additive manufacturing techniques in ABS material, allows palmar acquisitions, and its design and test are motivated by the following needs: (1) immobilizing the hand of patients during the palmar scanning to reduce involuntary movements affecting the scanning quality and (2) keeping hands open and in a correct position, especially to contrast the high degree of hypertonicity of spastic subjects. The resulting device can be used indifferently for the right and the left hand; it is provided in four-dimensional sizes and may be also suitable as a palmar support for the acquisition of the dorsal side of the hand.

OBJECTIVE: The differential diagnosis of Parkinson's disease (PD) and other conditions, such as essential tremor and drug-induced parkinsonian syndrome or normal aging brain, represents a diagnostic challenge. 123I-FP-CIT brain SPET is able to contribute to the differential diagnosis. Semiquantitative analysis of radiopharmaceutical uptake in basal ganglia (caudate nuclei and putamina) is very useful to support the diagnostic process. An artificial neural network classifier using 123I-FP-CIT brain SPET data, a classification tree (CIT), was applied. CIT is an automatic classifier composed of a set of logical rules, organized as a decision tree to produce an optimised threshold based classification of data to provide discriminative cut-off values. We applied a CIT to 123I-FP-CIT brain SPET semiquantitave data, to obtain cut-off values of radiopharmaceutical uptake ratios in caudate nuclei and putamina with the aim to diagnose PD versus other conditions. SUBJECTS AND METHOD: We retrospectively investigated 187 patients undergoing 123I-FP-CIT brain SPET (Millenium VG, G.E.M.S.) with semiquantitative analysis performed with Basal Ganglia (BasGan) V2 software according to EANM guidelines; among them 113 resulted affected by PD (PD group) and 74 (N group) by other non parkinsonian conditions, such as Essential Tremor and drug-induced PD. PD group included 113 subjects (60M and 53F of age: 60-81yrs) having Hoehn and Yahr score (HY): 0.5-1.5; Unified Parkinson Disease Rating Scale (UPDRS) score: 6-38; N group included 74 subjects (36M and 38 F range of age 60-80 yrs). All subjects were clinically followed for at least 6-18 months to confirm the diagnosis. To examinate data obtained by using CIT, for each of the 1,000 experiments carried out, 10% of patients were randomly selected as the CIT training set, while the remaining 90% validated the trained CIT, and the percentage of the validation data correctly classified in the two groups of patients was computed. The expected performance of an "average performance CIT" was evaluated. RESULTS: For CIT, the probability of correct classification in patients with PD was 84.19±11.67% (mean±SD) and in N patients 93.48±6.95%. For CIT, the first decision rule provided a value for the right putamen of 2.32±0.16. This means that patients with right putamen values <2.32 were classified as having PD. Patients with putamen values ≥2.32 underwent further analysis. They were classified as N if the right putamen uptake value was ≥3.02 or if the value for the right putamen was <3.02 and the age was ≥67.5 years. Otherwise the patients were classified as having PD. Other similar rules on the values of both caudate nuclei and left putamen could be used to refine the classification, but in our data analysis of these data did not significantly contribute to the differential diagnosis. This could be due to an increased number of more severe patients with initial prevalence of left clinical symptoms having a worsening in right putamen uptake distribution. CONCLUSION: These results show that CIT was able to accurately classify PD and non-PD patients by means of 123I-FP-CIT brain SPET data and provided also cut-off values able to differentially diagnose these groups of patients. Right putamen uptake values resulted as the most discriminant to correctly classify our patients, probably due to a certain number of subjects with initial prevalence of left clinical symptoms. Finally, the selective evaluation of the group of subjects having putamen values ≥2.32 disclosed that age was a further important feature to classify patients for certain right putamen values.

Background/purpose: We investigate the use of skin texture features from the inner forearm as a means for personal identification. The forearm offers a number of potential advantages in that it is a fairly accessible area, and, compared with other zones such as fingertips, is less exposed to the elements and more shielded from wear. Methods: We extract and combine skin textural features from two imaging devices (optical and capacitive) with the aim of discriminating between different individuals. Skin texture images from 43 subjects were acquired from three different body parts (back of the hand, forearm and palm); testing used the two sensors either separately or in combination. Results: Skin texture features from the forearm proved effective for discriminating between different individuals with overall recognition accuracy approaching 96%. Conclusions: We found that skin texture features from the forearm are highly individual-specific and therefore suitable for personal identification. Interestingly, forearm skin texture features yielded significantly better accuracy compared to the skin of the back of the hand and of the palm of the same subjects.

Keywords: image processing , personal identification , skin texture , texture analysis

This study aims to investigate the feasibility of using time-average holography to verify the integrity of skin tissue samples and detect changes in their mechanical response caused by exposure to thermal perturbations, radiations and mechanical loading. For that purpose, chicken skin samples are put into vibration and the corresponding modes are monitored by means of an optical set up based on time average holographic interferometry. Mode shapes of base samples computed by a parametric finite element model are consistent with experimental data. The holographic set up correctly detects the presence of defects previously included in the sample. Dynamic behavior of skin samples under various conditions of low/high temperature and load or exposed, for different periods of time, to UV radiation and microwaves also is successfully monitored. The reliability and robustness of the proposed approach is tested by performing the holographic observations on a large number of samples under different conditions. Potential benefits that may derive from the use of time-average holography in dermatology and plastic surgery (for example, in the quality control of artificial skin tissues to be implanted) are finally discussed.

Keywords: defects and exposure to heat/radiation/microwaves , modal analysis , Skin tissue , time-average holography

This paper presents an immersive virtual reality system (IVRS) that has been designed for unilateral amputees in order to reduce the phantom limb pain (PLP). The patient's healthy limb is tracked by using a motion sensor. Data of the limb in motion are used as input parameters to move the phantom limb in the immersive virtual reality system. In this way, the patient has the illusion of moving the phantom limb while moving the real and contra-lateral limb. The system has been implemented by using low cost and open technologies, and combines the Oculus Rift SDK2 device, the LeapMotion device, a motion sensor, and an engine for interactive 3D content and gaming generation (Unity 3D). The Oculus Rift head mounted display is used to provide the immersive experience.