This study aims to critically analyse the workflow of the in situ bioprinting procedure, presenti... more This study aims to critically analyse the workflow of the in situ bioprinting procedure, presenting a simulated neurosurgical case study, based on a real traumatic event, for collecting quantitative data in support of this innovative approach. After a traumatic event involving the head, bone fragments may have to be removed and a replacement implant placed through a highly demanding surgical procedure in terms of surgeon dexterity. A promising alternative to the current surgical technique is the use of a robotic arm to deposit the biomaterials directly onto the damaged site of the patient following a planned curved surface, which can be designed pre-operatively. Here we achieved an accurate planning-patient registration through pre-operative fiducial markers positioned around the surgical area, reconstructed starting from computed tomography images. Exploiting the availability of multiple degrees of freedom for the regeneration of complex and also overhanging parts typical of anatom...
The application of mechanical stimulation on bone tissue engineering constructs aims to mimic the... more The application of mechanical stimulation on bone tissue engineering constructs aims to mimic the native dynamic nature of bone. Although many attempts have been made to evaluate the effect of applied mechanical stimuli on osteogenic differentiation, the conditions that govern this process have not yet been fully explored. In this study, pre-osteoblastic cells were seeded on PLLA/PCL/PHBV (90/5/5 wt.%) polymeric blend scaffolds. The constructs were subjected every day to cyclic uniaxial compression for 40 min at a displacement of 400 μm, using three frequency values, 0.5, 1, and 1.5 Hz, for up to 21 days, and their osteogenic response was compared to that of static cultures. Finite element simulation was performed to validate the scaffold design and the loading direction, and to assure that cells inside the scaffolds would be subjected to significant levels of strain during stimulation. None of the applied loading conditions negatively affected the cell viability. The alkaline phosp...
UBORA is an educational and design online platform or infrastructure aimed at the collaborative d... more UBORA is an educational and design online platform or infrastructure aimed at the collaborative development of open-source medical devices (OSMD) to address current and future global healthcare challenges. It pretends to support the healthcare professionals and the medical industry with new methods for creation of innovative solutions that take into account needs, safety, feasibility, efficacy and performance. To support the implementation and testing of the UBORA e-infrastructure and to promote the future impact of OSMD, teaching-learning actuations play a fundamental role. In consequence, in parallel to the implementation of the mentioned infrastructure, a set of international design competitions and schools are being developed. In this study we present the results from the “First UBORA Design Competition”. This “First UBORA Design Competition” counted with a total of 113 submitted projects, from which 60 were selected for a second round. After such second round, 24 especially rel...
Although the adhesion of bacteria on surfaces is a widely studied process, to date, most of the w... more Although the adhesion of bacteria on surfaces is a widely studied process, to date, most of the works focus on a single species of microorganisms and are aimed at evaluating the antimicrobial properties of biomaterials. Here, we describe how a complex microbial community, i.e., the human gut microbiota, adheres to a surface to form stable biofilms. Two electrospun structures made of natural, i.e., gelatin, and synthetic, i.e., polycaprolactone, polymers were used to study their ability to both promote the adhesion of the human gut microbiota and support microbial growth in vitro. Due to the different wettabilities of the two surfaces, a mucin coating was also added to the structures to decouple the effect of bulk and surface properties on microbial adhesion. The developed biofilm was quantified and monitored using live/dead imaging and scanning electron microscopy. The results indicated that the electrospun gelatin structure without the mucin coating was the optimal choice for devel...
Tissue engineering (TE) is an interdisciplinary field that was introduced from the necessity of f... more Tissue engineering (TE) is an interdisciplinary field that was introduced from the necessity of finding alternative approaches to transplantation for the treatment of damaged and diseased organs or tissues. Unlike the conventional procedures, TE aims at inducing the regeneration of injured tissues through the implantation of customized and functional engineered tissues, built on the so-called ‘scaffolds’. These provide structural support to cells and regulate the process of new tissue formation. The properties of the scaffold are essentials, and they can be controlled by varying the biomaterial formulation and the fabrication technology used to its production. Pectin is emerging as an alternative biomaterial to non-degradable and high-cost petroleum-based biopolymers commonly used in this field. It shows several promising properties including biocompatibility, biodegradability, non-toxicity and gelling capability. Pectin-based formulations can be processed through different fabricat...
Supporting the expansion of best practices in Biomedical Engineering (BME) can facilitate pathway... more Supporting the expansion of best practices in Biomedical Engineering (BME) can facilitate pathway toward the providing universal health coverage and more equitable and accessible healthcare technologies, especially in low- and middle-income (LMI) settings. These best practices can act as drivers of change and may involve scientific-technological issues, human intervention during technology development, educational aspects, social performance management for improved interactions along the medical technology life cycle, methods for managing resources and approaches for the establishment of regulatory frameworks.The aim of our study was to identify weaknesses and strengths of the scientific, technological, socio-political, regulatory and educational landscape in BME in LMI resource settings. We thus analysed the current state-of-the-art through six dimensions considered fundamental for advancing quality and equity in healthcare: 1) relevant and 2) emergent technologies, 3) new paradigm...
Abstract The aim of this work is to design a robotic bioprinting platform able to fabricate a thr... more Abstract The aim of this work is to design a robotic bioprinting platform able to fabricate a three-dimensional structure onto irregular surfaces. With respect to the limitations of current in vitro bioprinting approach, widely used in scaffold-based tissue engineering – handling difficulty, risk of contamination, shape not matching with the defect site – this robotic bioprinter can offer an innovative solution allowing in situ bioprinting, a direct dispensing of biological materials onto and into the damaged site. The robotic platform was developed starting from the 5 degrees-of-freedom open source MOVEO robot from BCN3D. The hardware and the software of the original project were re-engineered to control the robot using LinuxCNC, a path planning algorithm was developed in Matlab®, and the end-effector was equipped with a pneumatic extruder. The algorithm automatically projects any generic printing pattern on the surface on which the scaffold will be 3D bioprinted. For each point, the algorithm calculates the joint angles to keep the end effector always perpendicular to the surface. A g-code file is then exported to Linux CNC adding parameters to control the air pressure and the printing speed. The robotic platform was tested to evaluate its performances. Resolution (~200 μm) and repeatability were estimated and preliminary in situ bioprinting tests were performed onto different irregular surfaces, including a physiologically relevant bone model.
Self-assembling bioinks offer the possibility to biofabricate with molecular precision, hierarchi... more Self-assembling bioinks offer the possibility to biofabricate with molecular precision, hierarchical control, and biofunctionality. For this to become a reality with widespread impact, it is essential to engineer these ink systems ensuring reproducibility and providing suitable standardization. We have reported a self-assembling bioink based on disorder-to-order transitions of an elastin-like recombinamer (ELR) to co-assemble with graphene oxide (GO). Here, we establish reproducible processes, optimize printing parameters for its use as a bioink, describe new advantages that the self-assembling bioink can provide, and demonstrate how to fabricate novel structures with physiological relevance. We fabricate capillary-like structures with resolutions down to ∼10 µm in diameter and ∼2 µm thick tube walls and use both experimental and finite element analysis to characterize the printing conditions, underlying interfacial diffusion-reaction mechanism of assembly, printing fidelity, and ma...
This study aims to critically analyse the workflow of the in situ bioprinting procedure, presenti... more This study aims to critically analyse the workflow of the in situ bioprinting procedure, presenting a simulated neurosurgical case study, based on a real traumatic event, for collecting quantitative data in support of this innovative approach. After a traumatic event involving the head, bone fragments may have to be removed and a replacement implant placed through a highly demanding surgical procedure in terms of surgeon dexterity. A promising alternative to the current surgical technique is the use of a robotic arm to deposit the biomaterials directly onto the damaged site of the patient following a planned curved surface, which can be designed pre-operatively. Here we achieved an accurate planning-patient registration through pre-operative fiducial markers positioned around the surgical area, reconstructed starting from computed tomography images. Exploiting the availability of multiple degrees of freedom for the regeneration of complex and also overhanging parts typical of anatom...
The application of mechanical stimulation on bone tissue engineering constructs aims to mimic the... more The application of mechanical stimulation on bone tissue engineering constructs aims to mimic the native dynamic nature of bone. Although many attempts have been made to evaluate the effect of applied mechanical stimuli on osteogenic differentiation, the conditions that govern this process have not yet been fully explored. In this study, pre-osteoblastic cells were seeded on PLLA/PCL/PHBV (90/5/5 wt.%) polymeric blend scaffolds. The constructs were subjected every day to cyclic uniaxial compression for 40 min at a displacement of 400 μm, using three frequency values, 0.5, 1, and 1.5 Hz, for up to 21 days, and their osteogenic response was compared to that of static cultures. Finite element simulation was performed to validate the scaffold design and the loading direction, and to assure that cells inside the scaffolds would be subjected to significant levels of strain during stimulation. None of the applied loading conditions negatively affected the cell viability. The alkaline phosp...
UBORA is an educational and design online platform or infrastructure aimed at the collaborative d... more UBORA is an educational and design online platform or infrastructure aimed at the collaborative development of open-source medical devices (OSMD) to address current and future global healthcare challenges. It pretends to support the healthcare professionals and the medical industry with new methods for creation of innovative solutions that take into account needs, safety, feasibility, efficacy and performance. To support the implementation and testing of the UBORA e-infrastructure and to promote the future impact of OSMD, teaching-learning actuations play a fundamental role. In consequence, in parallel to the implementation of the mentioned infrastructure, a set of international design competitions and schools are being developed. In this study we present the results from the “First UBORA Design Competition”. This “First UBORA Design Competition” counted with a total of 113 submitted projects, from which 60 were selected for a second round. After such second round, 24 especially rel...
Although the adhesion of bacteria on surfaces is a widely studied process, to date, most of the w... more Although the adhesion of bacteria on surfaces is a widely studied process, to date, most of the works focus on a single species of microorganisms and are aimed at evaluating the antimicrobial properties of biomaterials. Here, we describe how a complex microbial community, i.e., the human gut microbiota, adheres to a surface to form stable biofilms. Two electrospun structures made of natural, i.e., gelatin, and synthetic, i.e., polycaprolactone, polymers were used to study their ability to both promote the adhesion of the human gut microbiota and support microbial growth in vitro. Due to the different wettabilities of the two surfaces, a mucin coating was also added to the structures to decouple the effect of bulk and surface properties on microbial adhesion. The developed biofilm was quantified and monitored using live/dead imaging and scanning electron microscopy. The results indicated that the electrospun gelatin structure without the mucin coating was the optimal choice for devel...
Tissue engineering (TE) is an interdisciplinary field that was introduced from the necessity of f... more Tissue engineering (TE) is an interdisciplinary field that was introduced from the necessity of finding alternative approaches to transplantation for the treatment of damaged and diseased organs or tissues. Unlike the conventional procedures, TE aims at inducing the regeneration of injured tissues through the implantation of customized and functional engineered tissues, built on the so-called ‘scaffolds’. These provide structural support to cells and regulate the process of new tissue formation. The properties of the scaffold are essentials, and they can be controlled by varying the biomaterial formulation and the fabrication technology used to its production. Pectin is emerging as an alternative biomaterial to non-degradable and high-cost petroleum-based biopolymers commonly used in this field. It shows several promising properties including biocompatibility, biodegradability, non-toxicity and gelling capability. Pectin-based formulations can be processed through different fabricat...
Supporting the expansion of best practices in Biomedical Engineering (BME) can facilitate pathway... more Supporting the expansion of best practices in Biomedical Engineering (BME) can facilitate pathway toward the providing universal health coverage and more equitable and accessible healthcare technologies, especially in low- and middle-income (LMI) settings. These best practices can act as drivers of change and may involve scientific-technological issues, human intervention during technology development, educational aspects, social performance management for improved interactions along the medical technology life cycle, methods for managing resources and approaches for the establishment of regulatory frameworks.The aim of our study was to identify weaknesses and strengths of the scientific, technological, socio-political, regulatory and educational landscape in BME in LMI resource settings. We thus analysed the current state-of-the-art through six dimensions considered fundamental for advancing quality and equity in healthcare: 1) relevant and 2) emergent technologies, 3) new paradigm...
Abstract The aim of this work is to design a robotic bioprinting platform able to fabricate a thr... more Abstract The aim of this work is to design a robotic bioprinting platform able to fabricate a three-dimensional structure onto irregular surfaces. With respect to the limitations of current in vitro bioprinting approach, widely used in scaffold-based tissue engineering – handling difficulty, risk of contamination, shape not matching with the defect site – this robotic bioprinter can offer an innovative solution allowing in situ bioprinting, a direct dispensing of biological materials onto and into the damaged site. The robotic platform was developed starting from the 5 degrees-of-freedom open source MOVEO robot from BCN3D. The hardware and the software of the original project were re-engineered to control the robot using LinuxCNC, a path planning algorithm was developed in Matlab®, and the end-effector was equipped with a pneumatic extruder. The algorithm automatically projects any generic printing pattern on the surface on which the scaffold will be 3D bioprinted. For each point, the algorithm calculates the joint angles to keep the end effector always perpendicular to the surface. A g-code file is then exported to Linux CNC adding parameters to control the air pressure and the printing speed. The robotic platform was tested to evaluate its performances. Resolution (~200 μm) and repeatability were estimated and preliminary in situ bioprinting tests were performed onto different irregular surfaces, including a physiologically relevant bone model.
Self-assembling bioinks offer the possibility to biofabricate with molecular precision, hierarchi... more Self-assembling bioinks offer the possibility to biofabricate with molecular precision, hierarchical control, and biofunctionality. For this to become a reality with widespread impact, it is essential to engineer these ink systems ensuring reproducibility and providing suitable standardization. We have reported a self-assembling bioink based on disorder-to-order transitions of an elastin-like recombinamer (ELR) to co-assemble with graphene oxide (GO). Here, we establish reproducible processes, optimize printing parameters for its use as a bioink, describe new advantages that the self-assembling bioink can provide, and demonstrate how to fabricate novel structures with physiological relevance. We fabricate capillary-like structures with resolutions down to ∼10 µm in diameter and ∼2 µm thick tube walls and use both experimental and finite element analysis to characterize the printing conditions, underlying interfacial diffusion-reaction mechanism of assembly, printing fidelity, and ma...
The Law, Economics and Engineering of Advanced Medical Technologies, 2021
'The Law, Economics and Engineering of Advanced Medical Technologies' is an international Winter ... more 'The Law, Economics and Engineering of Advanced Medical Technologies' is an international Winter School addressed to graduate students, young researchers and professionals, part of the three-year Jean Monnet Module “European Health Law and Technology/ELaTe”, awarded in the framework of the Call for proposals 2019 – EAC-A02-2019 under the Erasmus+ Programme.
The school expands on the Project-Based Learning (PBL) methodology successfully applied in the Winter School "European Health Law & Biotechnology” (February 2021).
Teaching activities will be carried out three days per week and be divided in morning lectures on the fundamentals of European health law, medical devices design, HTA and market analysis. During the afternoon sessions participants will work in small cross-disciplinary teams (max 4/5 people), centered on the development of a particular medical device. The final examination will consist of the presentation of a project.
The School will unfold online, from the 17th to the 28th of January 2022 for a total of 63 hours. Classes begin at 10.00 AM and end at 6.30 PM, with an hour and a half break for lunch. Each class is 1.30 hours long, with a 30-minutes’ break. Six academic credits (in accordance with the European Credits Transfer and Accumulation System - ECTS) will be awarded upon successful completion of the Course, which requires the attendance of at least 90% of classes and passing the final examination. The teaching body includes academics from different backgrounds, such as law, engineering, management and innovation, offering a highly interdisciplinary perspective. All classes will be taught in English.
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Papers by Carmelo De Maria
The school expands on the Project-Based Learning (PBL) methodology successfully applied in the Winter School "European Health Law & Biotechnology” (February 2021).
Teaching activities will be carried out three days per week and be divided in morning lectures on the fundamentals of European health law, medical devices design, HTA and market analysis. During the afternoon sessions participants will work in small cross-disciplinary teams (max 4/5 people), centered on the development of a particular medical device. The final examination will consist of the presentation of a project.
The School will unfold online, from the 17th to the 28th of January 2022 for a total of 63 hours. Classes begin at 10.00 AM and end at 6.30 PM, with an hour and a half break for lunch. Each class is 1.30 hours long, with a 30-minutes’ break.
Six academic credits (in accordance with the European Credits Transfer and Accumulation System - ECTS) will be awarded upon successful completion of the Course, which requires the attendance of at least 90% of classes and passing the final examination.
The teaching body includes academics from different backgrounds, such as law, engineering, management and innovation, offering a highly interdisciplinary perspective.
All classes will be taught in English.