Search results for: medical implants

Authors: R. Trad Khodja, A. Guessmi, R. Ghoul, A. Mahtout, S. A. Benbouali, M. A. Boulahlib

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Cranioplasty is a surgical act that aims to restore cranial bone losses in order to protect the brain from external aggressions and to improve the patient's aesthetic appearance. This objective can be achieved by taking advantage of the current technological development in computer science and biomechanics. The objective of this paper is to present an approach for the realization of high-precision biocompatible cranial implants using new 3D printing technologies at the lowest cost. The proposed method is to reproduce the missing part of the skull by referring to its healthy contralateral part. Once the model is validated by the neurosurgeons, a mold is 3D printed for the production of a biocompatible implant in Poly-Methyl-Methacrylate (PMMA) acrylic cement. Using this procedure, ten patients underwent this procedure with excellent aesthetic results.

Keywords: cranioplasty, cranial defect, PMMA, 3d printing, custom made implants

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Authors: Ayda Khosravanihaghighi, Pramod Koshy, Bill Walsh, Vedran Lovric, Charles Christopher Sorrell

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There is an increasing demand for orthopedic implants owing to the increasing numbers of the aging population. Titanium alloy (Ti6Al4V) is a common material used for orthopedic implants owing to its advantageous properties in terms of good corrosion resistance, minimal elastic modulus mismatch with bone, bio-inertness, and high mechanical strength. However, it is important to improve the bioactivity and osseointegration of the titanium alloy and this can be achieved by coating the implant surface with suitable ceramic materials. In the present work, pure and doped-ceria (CeO₂) coatings were deposited by spin coating on the titanium alloy surface in order to enhance the biological interactions between the surface of the implant and the surrounding tissue. In order to examine the bone-binding ability of an implant, simulated body fluid (SBF) tests were conducted in order to assess the capability of apatite layer formation on the surface and thus predict in vivo bone bioactivity. Characterization was done using scanning electron microscopy (SEM) and X-ray diffraction (XRD) analyses to determine the extent of apatite formation. Preliminary tests showed that the CeO₂ coatings were biocompatible and that the extent of apatite formation and its characteristics can be enhanced by doping with suitable metal ions.

Keywords: apatite layer, biocompatibility, ceria, orthopaedic implant, SBF, spin coater, Ti-implant

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Authors: Stefanie Ficht, Lukas Schübel, Magdalena Kleybolte, Markus Eblenkamp, Jana Steger, Dirk Wilhelm, Petra Mela

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Although 3D printing as transformative technology has become of increasing interest in the medical field and the demand for biodegradable polymers has developed to a considerable extent, there are only a few additively manufactured, biodegradable implants on the market. Additionally, the sterilization of such implants and its side effects on degradation have still not been sufficiently studied. Within this work, thermosensitive poly p-dioxanone (PPDO) samples were printed with fused filament fabrication (FFF) and investigated. Subsequently, H₂O₂ plasma and gamma radiation were used as low-temperature sterilization techniques and compared among each other and the control group (no sterilization). In order to assess the effect of different sterilization on the degradation behavior of PPDO, the samples were immersed in phosphate-buffered solution (PBS) over 28 days, and surface morphology, thermal properties, molecular weight, inherent viscosity, and mechanical properties were examined at regular time intervals. The study demonstrates that PPDO was printed with great success and that thermal properties, molecular weight (Mw), and inherent viscosity (IV) were not significantly affected by the printing process itself. H₂O₂ plasma sterilization did not significantly harm the thermosensitive polymer, while gamma radiation lowered IV and Mw statistically significantly compared to the control group (p < 0.001). During immersion in PBS, a decrease in Mw and mechanical strength occurred for all samples. However, gamma sterilized samples were affected to a much higher extent compared to the two other sample groups both in final values and timeline. This was confirmed by scanning electron microscopy showing no changes of surface morphology of (non-sterilized) control samples, first microcracks appearing on plasma sterilized samples after two weeks while being present on gamma sterilized samples already immediately after radiation to then further deteriorate over immersion duration. To conclude, we demonstrated that FFF and H₂O₂ plasma sterilization are well suited for processing thermosensitive, biodegradable polymers used for the development of innovative short-term medical applications.

Keywords: additive manufacturing, sterilization, biodegradable, thermosensitive, medical application

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Authors: Daeung Jung

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Background: In case of patients with missing teeth, multiple implant restoration has been widely used and is inevitable. To increase its survival rate, it is important to understand the influence of different implant designs on inter-implant crestal bone resorption. There are several implant systems designed to minimize loss of crestal bone, and the Astra Tech and Brånemark Implant are two of them. Aim/Hypothesis: The aim of this 10-year study was to compare the height of inter-implant bone crest in two implant systems; the Astra Tech and the Brånemark implant system. Material and Methods: In this retrospective study, 40 consecutively treated patients were utilized; 23 patients with 30 sites for Astra Tech system and 17 patients with 20 sites for Brånemark system. The implant restoration was comprised of splinted crown in partially edentulous patients. Radiographs were taken immediately after 1st surgery, at impression making, at prosthetics setting, and annually after loading. Lateral distance from implant to bone crest, inter-implant distance was gauged, and crestal bone height was measured from the implant shoulder to the first bone contact. Calibrations were performed with known length of thread pitch distance for vertical measurement, and known diameter of abutment or fixture for horizontal measurement using ImageJ. Results: After 10 years, patients treated with Astra Tech implant system demonstrated less inter-implant crestal bone resorption when implants had a distance of 3mm or less between them. In cases of implants that had a greater than 3 mm distance between them, however, there appeared to be no statistically significant difference in crestal bone loss between two systems. Conclusion and clinical implications: In the situation of partially edentulous patients planning to have more than two implants, the inter-implant distance is one of the most important factors to be considered. If it is impossible to make sure of having sufficient inter-implant distance, the implants with less micro gap in the fixture-abutment junction, less traumatic 2nd surgery approach, and the adequate surface topography would be choice of appropriate options to minimize inter-implant crestal bone resorption.

Keywords: implant design, crestal bone loss, inter-implant distance, 10-year retrospective study

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Authors: A. Razavykia, A. Esmaeilzadeh, S. Iranmanesh

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Many orthopedic implants like proximal humerus cases require lower surface roughness and almost immediate/short lead time surgery. Thus, rapid response from the manufacturer is very crucial. Tool path strategy of milling process has a direct influence on the surface roughness and lead time of medical implant. High-speed milling as promised process would improve the machined surface quality, but conventional or super-abrasive grinding still required which imposes some drawbacks such as additional costs and time. Currently, many CAD/CAM software offers some different tool path strategies to milling free form surfaces. Nevertheless, the users must identify how to choose the strategies according to cutting tool geometry, geometry complexity, and their effects on the machined surface. This study investigates the effect of different tool path strategies for milling a proximal humerus head during finishing operation on stainless steel 316L. Experiments have been performed using MAHO MH700 S vertical milling machine and four machining strategies, namely, spiral outward, spiral inward, and radial as well as zig-zag. In all cases, the obtained surfaces were analyzed in terms of roughness and dimension accuracy compared with those obtained by simulation. The findings provide evidence that surface roughness, dimensional accuracy, and machining time have been affected by the considered tool path strategy.

Keywords: CAD/CAM software, milling, orthopedic implants, tool path strategy

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Authors: Chung-Yu Wu, Chia-Chi Chang, Wei-Ming Chen, Pu-Wei Wu, Shih-Fan Chen, Po-Chun Chen

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Electrostimulation medical devices for neural diseases require electroactive and biocompatible materials to transmit signals from electrodes to targeting tissues. Protection of surrounding tissues has become a great challenge for long-term implants. In this study, we designed back-end processes with compatible, efficient, and reliable advantages over the current state-of-the-art. We explored a hermetic packaging process with high quality of adhesion and uniformity as the biocompatible devices for long-term implantation. This approach is able to provide both excellent biocompatibility and protection to the biomedical electronic devices by performing conformal coating of biocompatible materials. We successfully developed a packaging process that is capable of exposing the stimulating electrode and cover all other faces of chip with high quality of protection to prevent leakage of devices and body fluid.

Keywords: biocompatible package, medical microelectronics, surface coating, long-term implantation

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Authors: Mihika Shivkumar, Krishna Kumar, C. Perisamy

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3D printing is a method of manufacturing wherein materials, such as plastic or metal, are deposited in layers one on top of the other to produce a three dimensional object. 3D printing is most commonly associated with creating engineering prototypes. However, its applications in the field of human health care have been frequently disregarded. Medical applications for 3D printing are expanding rapidly and are envisaged to revolutionize health care. Medical applications for 3D printing, both present and its potential, can be categorized broadly, including: creation of customized prosthetics tissue and organ fabrication; creation of implants, and anatomical models and pharmaceutical research regarding drug dosage forms. This piece breaks down bioprinting in the healthcare sector. It focuses on the better subtle elements of every particular point, including how 3D printing functions in the present, its impediments, and future applications in the health care sector.

Keywords: bio-printing, prototype, drug delivery, organ regeneration

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Authors: Roxana Maria Angelescu, Raluca Ion, Anişoara Cîmpean, Doina Răducanu, Mariana Lucia Angelescu

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In an attempt to find titanium alloys that fulfill the requirements for mechanical and biological compatibility, laboratory and material related tests were performed during the years, as well as preclinical and clinical trials. The multidisciplinary scientific research facilitates the global evaluation of biocompatibility and osseointegration regarding the dental implant alloys. The aim of this study was to determine the in vitro biocompatibility of three modern titanium alloys: Ti-31.7Nb-6.21Zr-1.4Fe-0.16O (wt%), Ti-36.5Nb-4.5Zr-3Ta-0.16O (wt%) and Ti-20Nb-5Ta (wt%), in order to establish whether the use of these titanium alloys can have any toxic or injurious effects on biological systems. The commonly used Ti-6Al-4V alloy was investigated as a reference material. The behavior of MC3T3-E1 pre-osteoblasts on all these four metallic surfaces was evaluated. The tests of immunofluorescence, cytotoxicity and cellular proliferation lead to the conclusion that the newly-developed titanium alloys elicit a good cellular response in terms of cellular survival, adhesion, morphology and proliferative potential as well.

Keywords: biocompatibility tests, dental implants, titanium alloys, biomedical engineering

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Authors: Ravi Sheshala, Annie Lee, Ai Lin Ong, Ling Ling Cheu, Thiagarajan Madheswaran, Thankur R. R. Singh

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The objectives of the present research work were to develop and characterize biodegradable controlled release photo cross-linked implants of Triamcinolone Acetonide (TA) for the treatment of chronic ocular diseases. The photo cross-linked implants were prepared using film casting technique by mixing TA (2.5%) polyethylene glycol diacrylate (PEGDA 700), pore formers (mannitol, maltose, and gelatin) and the photoinitiator (Irgacure 2959). The resulting mixture was injected into moulds using 21 G and subjected to photocrosslinking at 365 nm. Scanning electron microscopy results demonstrated that more pores were formed in the films with the increase in the concentration of pore formers from 2%-10%. The maximum force required to break the films containing 2-10% of pore formers were determined in both dry and wet conditions using texture analyzer and found that films in a dry condition required a higher force to break compared to wet condition and blank films. In vitro drug release from photo cross-linked films were determined by incubating samples in 50 ml PBS pH 7.4 at 37 C and the samples were analyzed for drug release by HPLC. The films demonstrated a biphasic release profile i.e. an initial burst release (<20%) on the first day followed by a constant and continuous drug release in a controlled manner for 42 days. The drug release from all formulations followed the first-order release pattern and the combination of diffusion and erosion release mechanism. In conclusion, the developed formulations were able to provide controlled drug delivery to treat the chronic ocular diseases.

Keywords: controlled release, ophthalmic, PEGDA, photocrosslinking, pore formers

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Authors: Ariba Siddiqui, Amber Khan

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The need for bio-implantable devices in the field of medical sciences has been increasing day by day; however, the charging of these devices is a major issue. Batteries, a very common method of powering the implants, have a limited lifetime and bulky nature. Therefore, as a replacement of batteries, acoustic power transfer (APT) technology is being accepted as the most suitable technique to wirelessly power the medical implants in the present scenario. The basic model of APT consists of piezoelectric transducers that work on the principle of converse piezoelectric effect at the transmitting end and direct piezoelectric effect at the receiving end. This paper provides mechanistic insight into the parameters affecting the design and efficient working of acoustic power transfer systems. The optimum design considerations have been presented that will help to compress the size of the device and augment the intensity of the pressure wave. A COMSOL model of the PZT (Lead Zirconate Titanate) transducer was developed. The model was simulated and analyzed on a frequency spectrum. The simulation results displayed that the efficiency of these devices is strongly dependent on the frequency of operation, and a wrong choice of the operating frequency leads to the high absorption of acoustic field inside the tissue (medium), poor power strength, and heavy transducers, which in effect influence the overall configuration of the acoustic systems. Considering all the tradeoffs, the simulations were performed again by determining an optimum frequency (900 kHz) that resulted in the reduction of the transducer's thickness to 1.96 mm and augmented the power strength with an intensity of 432 W/m². Thus, the results obtained after the second simulation contribute to lesser attenuation, lightweight systems, high power intensity, and also comply with safety limits provided by the U.S Food and Drug Administration (FDA). It was also found that the chosen operating frequency enhances the directivity of the acoustic wave at the receiver side.

Keywords: acoustic power, bio-implantable, COMSOL, Lead Zirconate Titanate, piezoelectric, transducer

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Authors: Kirill M. Dubovikov, Ekaterina S. Marchenko, Gulsharat A. Baigonakova

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NiTi alloys are widely used as implants in medicine due to their unique properties such as superelasticity, shape memory effect and biocompatibility. However, despite these properties, one of the major problems is the release of nickel after prolonged use in the human body under dynamic stress. This occurs due to oxidation and cracking of NiTi implants, which provokes nickel segregation from the matrix to the surface and release into living tissues. As we know, nickel is a toxic element and can cause cancer, allergies, etc. One of the most popular ways to solve this problem is to create a corrosion resistant coating on NiTi. There are many coatings of this type, but not all of them have good biocompatibility, which is very important for medical implants. Coatings based on calcium phosphate phases have excellent biocompatibility because Ca and P are the main constituents of the mineral part of human bone. This fact suggests that a Ca-P coating on NiTi can enhance osteogenesis and accelerate the healing process. Therefore, the aim of this study is to investigate the structure of Ca-P coating on NiTi substrate. Plasma assisted radio frequency (RF) sputtering was used to obtain this film. This method was chosen because it allows the crystallinity and morphology of the Ca-P coating to be controlled by the sputtering parameters. It allows us to obtain three different NiTi samples with Ca-P coating. XRD, AFM, SEM and EDS were used to study the composition, structure and morphology of the coating phase. Scratch tests were carried out to evaluate the adhesion of the coating to the substrate. Wettability tests were used to investigate the hydrophilicity of the different coatings and to suggest which of them had better biocompatibility. XRD showed that the coatings of all samples were hydroxyapatite, but the matrix was represented by TiNi intermetallic compounds such as B2, Ti2Ni and Ni3Ti. The SEM shows that the densest and defect-free coating has only one sample after three hours of sputtering. Wettability tests show that the sample with the densest coating has the lowest contact angle of 40.2° and the largest free surface area of 57.17 mJ/m2, which is mostly disperse. A scratch test was carried out to investigate the adhesion of the coating to the surface and it was shown that all coatings were removed by a cohesive mechanism. However, at a load of 30N, the indenter reached the substrate in two out of three samples, except for the sample with the densest coating. It was concluded that the most promising sputtering mode was the third, which consisted of three hours of deposition. This mode produced a defect-free Ca-P coating with good wettability and adhesion.

Keywords: biocompatibility, calcium phosphate coating, NiTi alloy, radio frequency sputtering.

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Authors: Mostafa Solati

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Objectives: Considering the gap of information regarding the optimal antimicrobial efficacy of metronidazole for application in the implant screw hole, this study aimed to compare the antimicrobial efficacy of 0.75% metronidazole and 2% chlorhexidine (CHX) gel applied in the implant screw hole. Materials and Methods: This randomized controlled clinical trial evaluated 60 implants (20 patients, each requiring three implants) in three groups (n=20). In group 1, 0.75% metronidazole gel was applied to the implant screw hole. In group 2, 2% CHX gel was applied, and in group 3, no material was used. Microbial samples were collected from the screw holes after three months, and the microbial colonies were counted. Data were analyzed using ANOVA. Results: The number of bacteria in the control group was significantly higher than that in 0.75% metronidazole gel and 2% CHX groups (P<0.05). The CHX group caused the maximum reduction in colony count with no significant difference from the metronidazole group (P>0.05). Conclusion: The application of 0.75% metronidazole gel and 2% CHX can effectively decrease the colony count in the implant screw hole and can probably play a role in the preservation of peri-implant tissue health.

Keywords: dental implant, metronidazole, CHX, screw hole

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Authors: Mohammad Hossein Pazandeh, Monir Doudi, Sona Rostampour Yasouri

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—Results The prudent administration of antibiotics aims to avoid the side effects and the microbes' resistance to antibiotics. An approach developing methods of local administration of antibiotics is especially required for localized infections caused by bacterial colonization of medical devices or implant materials. Among the wide variety of materials used as drug delivery systems, bioactive glasses (BG) have large utilization in regenerative medicine . firstly, the production of bioactive glass/nickel oxide/tin dioxide nanocomposite using sol-gel method, and then, the controlled release of imipenem from the double metal oxide/bioactive glass nanocomposite, and finally, the investigation of the antibacterial property of the nanocomposite. against a number of implant-related infectious agents. In this study, BG/SnO2 and BG/NiO single systema with different metal oxide present and BG/NiO/SnO2 nanocomposites were synthesized by sol-gel as drug carriers for tetracycline and imepinem. These two antibiotics were widely used for osteomyelitis because of its favorable penetration and bactericidal effect on all the probable osteomyelitis pathogens. The antibacterial activity of synthesized samples were evaluated against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa as bacteria model using disk diffusion method. The BG modification using metal oxides results to antibacterial property of samples containing metal oxide with highest efficiency for nancomposite. bioactivity of all samples was assessed by determining the surface morphology, structural and composition changes using scanning electron microscopy (SEM), FTIR and X-ray diffraction (XRD) spectroscopy, respectively, after soaking in simulated body fluid (SBF) for 28 days. The hydroxyapatite formation was clearly observed as a bioactivity measurement. Then, BG nanocomposite sample was loaded using two antibiotics, separately and their release profiles were studied. The BG nancomposite sample was shown the slow and continuous drug releasing for a period of 72 hours which is desirable for a drug delivery system. The loaded antibiotic nanocomposite sample retaining antibacterial property and showing inactivation effect against bacteria under test. The modified bioactive glass forming hydroxyapatite with controlled release drug and effective against bacterial infections can be introduced as scaffolds for bone implants after clinical trials for biomedical applications . Considering the formation of biofilm by infectious bacteria after sticking on the surfaces of implants, medical devices, etc. Also, considering the complications of traditional methods, solving the problems caused by the above-mentioned microorganisms in technical and biomedical industries was one of the necessities of this research.

Keywords: antibacterial, bioglass, drug delivery system, sol- gel

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Authors: Minjung Park, Jimin Park, Youngwoon Kim, Hyungseop Han, Myoungryul Ok, Hojeong Jeon, Hyunkwang Seok, Yuchan Kim

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Magnesium is an essential element in human body and has unique characteristics such as bioabsorbable and biodegradable properties. Therefore, there has been much attention on studies on the implants based on magnesium to avoid subsequent surgery. However, high amount of hydrogen gas is generated by relatively severe corrosion of magnesium especially in aqueous condition with chloride ions. And it contributes to the causes of swelling of skin and causes consequent inflammation of soft tissue where is directly in contact with implants. Therefore, there is still concern about the safety of the using biodegradable magnesium alloys, which is limited to various applications. In this study, we analyzed the influence of coenzyme on corrosion behavior of magnesium. The analysis of corrosion rate was held by using Hanks’ balanced salt solution (HBSS) as a body stimulated fluid and in condition of 37°C. Thus, with deferring the concentration of the coenzyme used in this study, corrosion rates from 0.0654ml/ cm² to 0.0438ml/cm² were observed in immersion tests. Also, comparable results were obtained in electrochemical tests. Results showed that hydrogen gas produced from corrosion of magnesium can be controlled.

Keywords: biodegradable magnesium, biomaterials, coenzyme, corrosion

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Authors: Trad Khodja Rafik, Mahtout Amine, Ghoul Rachid, Benbouali Amine, Boulahlib Amine, Hariza Abdelmalik

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Cranioplasty with custom implant realized using 3D printing technology. Cranioplasty is a surgical act that aims restoring cranial bone losses in order to protect the brain from external aggressions and to improve the patient aesthetic appearance. This objective can be achieved with taking advantage of the current technological development in computer science and biomechanics. The objective of this paper it to present an approach for the realization of high precision biocompatible cranial implants using new 3D printing technologies at the lowest cost. The proposed method is to reproduce the missing part of the skull by referring to its healthy contralateral part. Once the model is validated by the neurosurgeons, a mold is 3D printed for the production of a biocompatible implant in Poly-Methyl-Methacrylate (PMMA) acrylic cement. Using this procedure four patients underwent this procedure with excellent aesthetic results.

Keywords: cranioplasty, cranial bone loss, 3D printing technology, custom-made implants, PMMA

Procedia PDF Downloads 80

Authors: Dae Kyung Choi, Won Man Park, Kyungsoo Kim, Yoon Hyuk Kim

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The interspinous process devices have been recently used due to its advantages such as minimal invasiveness and less subsidence of the implant to the osteoporotic bone. In this paper, we have analyzed the influences of ligature tightening of several interspinous process devices using finite element analysis. Four types of interspinous process implants were inserted to the L3-4 spinal motion segment based on their surgical protocols. Inferior plane of L4 vertebra was fixed and 7.5 Nm of extension moment were applied on superior plane of L3 vertebra with 400N of compressive load along follower load direction and pretension of the ligature. The stability of the spinal unit was high enough than that of intact model. The higher value of pretension in the ligature led the decrease of dynamic stabilization effect in cases of the WallisTM, DiamTM, Viking, and Spear®. The results of present study could be used to evaluate surgical option and validate the biomechanical characteristics of the spinal implants.

Keywords: interspinous process device, bone fracture risk, lumbar spine, finite element analysis

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Authors: Athanasios Triantafyllou, Georgios Papagiannis, Vassilios Nikolaou, Panayiotis J. Papagelopoulos, George C. Babis

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In vitro measurements are widely used in order to predict THAs wear rate implementing gait kinematic and kinetic parameters. Clinical tests of materials and designs are crucial to prove the accuracy and validate such measurements. The purpose of this study is to examine the affection of THA gait kinematics and kinetics on wear during gait, the essential functional activity of humans, by comparing in vivo gait data to in vitro results. Our study hypothesis is that both implants will present the same hip joint kinematics and kinetics during gait. 127 unilateral primary cementless total hip arthroplasties were included in the research. Independent t-tests were used to identify a statistically significant difference in kinetic and kinematic data extracted from 3D gait analysis. No statistically significant differences observed at mean peak abduction, flexion and extension moments between the two groups (P.abduction= 0,125, P.flexion= 0,218, P.extension= 0,082). The kinematic measurements show no statistically significant differences too (Prom flexion-extension= 0,687, Prom abduction-adduction= 0,679). THA kinematics and kinetics during gait are important biomechanical parameters directly associated with implants wear. In vitro studies report less wear in CoC than CoXLPE when tested with the same gait cycle kinematic protocol. Our findings confirm that both implants behave identically in terms of kinematics in the clinical environment, thus strengthening in vitro results of CoC advantage. Correlated to all other significant factors that affect THA wear could address in a complete prism the wear on CoC and CoXLPE.

Keywords: total hip arthroplasty biomechanics, THA gait analysis, ceramic on ceramic kinematics, ceramic on XLPE kinetics, total hip replacement wear

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Authors: Khaja Moiduddin, Sherif Mohammed Elseufy, Hisham Alkhalefah

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Recent advances in three-dimensional (3D) printing, medical imaging, and implant design may alter how craniomaxillofacial surgeons construct individualized treatments using patient data. By utilizing medical image data, medical professionals can obtain detailed information about a patient's injuries, enabling them to conduct a thorough preoperative assessment while ensuring the implant's accuracy. However, selecting the right implant material requires careful consideration of various mechanical properties. This study aims to compare the two commonly used implant material for cranial reconstruction which includes titanium (Ti6Al4V) and Polyetheretherketone (PEEK). Biomechanical analysis was performed to study the implant behavior, by keeping the implant design and fixation constant in both cases. A finite element model was created and analyzed under loading conditions. The finite element analysis proves that although Ti6Al4V is stronger than PEEK but, its mechanical strength is adequate to bear the loads of the adjacent bone tissue.

Keywords: cranial reconstruction, titanium implants, PEEK, finite element model

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Authors: Abdulsalam A. Al-Tamimi, Chris Peach, Paulo Rui Fernandes, Paulo J. Bartolo

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Bone fixation implants currently used to treat traumatic fractured bones and to promote fracture healing are built with biocompatible metallic materials such as stainless steel, cobalt chromium and titanium and its alloys (e.g., CoCrMo and Ti6Al4V). The noticeable stiffness mismatch between current metallic implants and host bone associates with negative outcomes such as stress shielding which causes bone loss and implant loosening leading to deficient fracture treatment. This paper, part of a major research program to design the next generation of bone fixation implants, describes the combined use of three-dimensional (3D) topology optimization (TO) and additive manufacturing powder bed technology (Electron Beam Melting) to redesign and fabricate the plates based on the current standard one (i.e., locking compression plate). Topology optimization is applied with an objective function to maximize the stiffness and constraint by volume reductions (i.e., 25-75%) in order to obtain optimized implant designs with reduced stress shielding phenomenon, under different boundary conditions (i.e., tension, bending, torsion and combined loads). The stiffness of the original and optimised plates are assessed through a finite-element study. The TO results showed actual reduction in the stiffness for most of the plates due to the critical values of volume reduction. Additionally, the optimized plates fabricated using powder bed techniques proved that the integration between the TO and additive manufacturing presents the capability of producing stiff reduced plates with acceptable tolerances.

Keywords: additive manufacturing, locking compression plate, finite element, topology optimization

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Authors: Abdelghani Boucheham, Ahcene Karaali, Amar Manseri

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Nanostructured Titania layers formed on the surface of titanium and titanium alloys by anodic oxidation play an important role in the enhancement of their biocompatibility and osseointegration in the human body. In the current work, highly ordered titania nanotube array films were elaborated on Ti₆Al₄V medical grade alloys in organic electrolyte containing ethylene glycol, 0.2 wt. % NH₄F and 4 vol. % H₂O at an applied potential of 60 V for different durations. The diameters, lengths and wall thicknesses of the obtained nanotubes were characterized by scanning electronic microscopy (SEM).

Keywords: anodization, dental implants, titania nanotubes, titanium alloys, SEM

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Authors: Fernanda A. Vechietti, Natália O. B. Muniz, Laura C. Treccani, Kurosch. Rezwan, Luis Alberto dos Santos

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CoCr alloys are widely used in prosthetic implants due to their excellent mechanical properties, such as good tensile strength, elastic modulus and wear resistance. Their biocompatibility and lack of corrosion are also prominent features of this alloy. One of the most effective and simple ways to protect metal’s surfaces are treatments, such as electrochemical oxidation by passivation, which is used as a protect release of metallic ions. Another useful treatment is the electropolishing, which is used to reduce the carbide concentration and protrusion at the implanted surface. Electropolishing is a cheap and effective method for treatment of implants, which generally has complex geometries. The purpose of this study is surface modification of the alloy CoCr(ASTM F90-09) by different methods: polishing, electro polishing, passivation and heat treatment for application as biomaterials. The modification of the surface was studied and characterized by SEM, profilometry, wettability and compared to the surface of the samples untreated. The heat treatment and of passivation increased roughness (0.477 µm and 0.825 µm) the samples in relation the sample electropolished and polished(0.131 µm and 0.274 µm) and were observed the improve wettability’s with the increase the roughness.

Keywords: biomaterial, CoCr, surface treatment, heat treatment, roughness

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Authors: Asaf Toker

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Matricelf developed a technology that enables the production of autologous engineered tissue composed of matrix and cells derived from patients Omentum biopsy. The platform showed remarkable pre-clinical results for several medical conditions. The company recently licensed the technology that enabled scientist at Tel Aviv university that 3D printed a human heart from human cells and matrix for the first time in human history. The company plans to conduct its first human clinical trial for Acute Spinal Cord Injury (SCI) early in 2023.

Keywords: tissue engineering, regenerative medicine, spinal Cord Injury, autologous implants, iPSC

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Authors: Xing Wang, Lin Feng, Lingling E., Hongchen Liu

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In patients with type 2 diabetes mellitus (DM) there is poorer quality osseointegration than in non-diabetic (n-DM) patients, and the success of dental implants is less. Recent studies have demonstrated that insulin could stimulate bone cells to produce and accelerate implant osseointegration in DM patients.This raised the question whether insulin could provide local bone anabolic effects in non-diabetic patients. In this study,48 SD rats were divided into four groups randomly: DM group, DM+insulin group, n-DM group, n-DM + insulin group. All rats were implanted the titanium implant near the epiphyseal end of tibia, then the DM + insulin and n-DM + insulin group received twice-daily subcutaneous injections of insulin (10U/day).Two,four and eight weeks after implantation, rats were killed in batches. Histomorphometry and immunohistochemistry were used to evaluate bone formation and osseointegration. The amount of newly formed bone, Implant–bone contact and the expression of OCN,RUNX2 in the DM+insulin, n-DM and n-DM+insulin group were significantly more than in the DM group (p<0.05). Compared with the n-DM group,the Implant–bone contact and expression of OCN,RUNX2 were significantly increased in n-DM+insulin group (p< 0.05). Taken together,these observations provide evidence that insulin has the potential to increase bone formation and osseointegration around implant not only in diabetic subjects but also in non-diabetic subject.

Keywords: insulin, diabetes mellitus, osseointegration, dental implants

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Authors: Bertalan Jillek, Péter Szabó, Judit Kopniczky, István Szabó, Balázs Patczai, Kinga Turzó

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Hip and knee prostheses are one of the most frequently used medical implants, that can significantly improve patients’ quality of life. Long term success and biointegration of these prostheses depend on several factors, like bulk and surface characteristics, construction and biocompatibility of the material. The applied surgical technique, the general health condition and life-quality of the patient are also determinant factors. Medical devices used in orthopedic surgeries have different surfaces depending on their function inside the human body. Surface roughness of these implants determines the interaction with the surrounding tissues. Numerous modifications have been applied in the recent decades to improve a specific property of an implant. Our goal was to compare the surface characteristics of typical implant materials used in orthopedic surgery and traumatology. Morphological and chemical structure of Vortex plate anodized titanium, cemented THR (total hip replacement) stem high nitrogen REX steel (SS), uncemented THR stem and cup titanium (Ti) alloy with titanium plasma spray coating (TPS), cemented cup and uncemented acetabular liner HXL and UHMWPE and TKR (total knee replacement) femoral component CoCrMo alloy (Sanatmetal Ltd, Hungary) discs were examined. Visualization and elemental analysis were made by scanning electron microscopy (SEM) and energy dispersive spectroscopy (EDS). Surface roughness was determined by atomic force microscopy (AFM) and profilometry. SEM and AFM revealed the morphological and roughness features of the examined materials. TPS Ti presented the highest Ra value (25 ± 2 μm, followed by CoCrMo alloy (535 ± 19 nm), Ti (227 ± 15 nm) and stainless steel (170 ± 11 nm). The roughness of the HXL and UHMWPE surfaces was in the same range, 147 ± 13 nm and 144 ± 15 nm, respectively. EDS confirmed typical elements on the investigated prosthesis materials: Vortex plate Ti (Ti, O, P); TPS Ti (Ti, O, Al); SS (Fe, Cr, Ni, C) CoCrMo (Co, Cr, Mo), HXL (C, Al, Ni) and UHMWPE (C, Al). The results indicate that the surface of prosthesis materials have significantly different features and the applied investigation methods are suitable for their characterization. Contact angle measurements and in vitro cell culture testing are further planned to test their surface energy characteristics and biocompatibility.

Keywords: morphology, PE, roughness, titanium

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Authors: Saimir Heta, Ilma Robo, Dhimiter Papakozma, Eduart Kapaj, Vera Ostreni

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Introduction: The biocompatible materials applied to the implant surfaces are the target of recent literature studies. Methodologies: Modification of implant surfaces in different ways such as application of additional ions, surface microstructure change, surface or laser ultrasound alteration, or application of various substances such as recombinant proteins are among the most affected by articles published in the literature. The study is of review type with the main aim of finding the different ways that the mesenchymal cell reaction to these materials is, according to the literature, in the same percentage positive to the osteointegration process. Results: It is emphasized in the literature that implant success as a key evaluation key has more to implement implant treatment protocol ranging from dental health amenity and subsequent of the choice of implant type depending on the alveolar shape of the ridge level. Conclusions: Osteointegration is a procedure that should initially be physiologically independent of the type of implant pile material. With this physiological process, it can not "boast" for implant success or implantation depending on the brand of the selected implant, as the breadth of synthetic or natural materials that promote osteointegration is relatively large.

Keywords: mesenchymal cells, implants, review, biocompatible materials

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Authors: Joaquim de Almeida Dultra, Daiana Cristina Pereira Santana, Fátima Karoline Alves Araújo Dultra, Liliane Akemi Kawano Shibasaki, Mariana Machado Mendes de Carvalho, Ieda Margarida Crusoé Rocha Rebello

Abstract:

Defects originating from mandibular resections can cause significant functional impairment and facial disharmony, and they have complex rehabilitation. The aim of this report is to demonstrate the authors' experience facing challenging rehabilitation after mandibular resection in a patient with ameloblastoma. Clinical and surgical steps are described simultaneously, highlighting the adaptation of the final fixed prosthesis, reported in an unprecedented way in the literature. A 37-year-old male patient was seen after a sports accident, where a pathological fracture in the symphysis and left mandibular body was identified, where a large radiolucent lesion was found. The patient underwent resection, bone graft, distraction osteogenesis, rehabilitation with dental implants, prosthesis, and finally, orofacial harmonization, in an interval of six years. Rehabilitation should consider the patient's needs individually and should have as the main objective to provide similar aesthetics and function to that present before the disease. We also emphasize the importance of interdisciplinary work during the course of rehabilitation.

Keywords: ameloblastoma, mandibular reconstruction, distraction osteogenesis, dental implants. dental prosthesis, implant-supported, treatment outcome

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Authors: Eugene Ivanov, Eduardo del-Rio, Igor Kapchenko, Maija Nystrӧm, Juha Kotila

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Series of low modulus beta Ti alloy billets and powders can be produced in commercial quantities using a combination of electron beam melting (EBM) and EIGA atomization processes. In the present study, TNZT alloy powder was produced and processed in the EOSINT M290 laser sintering system to produce parts for mechanical testing. Post heat treatments such as diffusion annealing to reduce internal stresses or hot isostatic pressing to remove closed pores were not applied. The density can visually be estimated to be > 99,9 %. According to EDS study Nb, Zr, and Ta are distributed homogeneously throughout the printed sample. There are no indications for any segregation or chemical inhomogeneity, i.e. variation of the element distribution. These points to the fact that under the applied experimental conditions the melt generated by the laser rapidly cools down in the SLM (Selective Laser Melting) process. The selective laser sintering yielded dense structures with relatively good surface quality. The mechanical properties, especially the elongation (24%) along with tensile strength ( > 500MPa) and modulus of elasticity (~60GPa), were found to be promising compared to titanium alloys in general.

Keywords: beta titanium alloys, additive manufacturing, powder, implants

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Authors: Bar Y. Ainuz, Harry M. Salinas, Aleeza Ali, Eli B. Levitt, Austin J. Pourmoussa, Antoun Bouz, Miguel A. Medina

Abstract:

Introduction: Breast conservation therapy remains the mainstay surgical treatment for early breast cancer. Oncoplastic techniques, in conjunction with lumpectomy and adjuvant radiotherapy, have been demonstrated to achieve good aesthetic results without adversely affecting cancer outcomes in the treatment of patients with macromastia or significant ptosis. In our patient population, many women present for breast conservation with pre-existing cosmetic implants or with breast volumes too small for soft tissue, only oncoplastic techniques. Our study evaluated a consecutive series of patients presenting for breast conservation undergoing concomitant oncoplastic-augmentation-mastopexy (OAM) with a contralateral augmentation-mastopexy for symmetry. Methods: OAM surgical technique involves simultaneous lumpectomy with exchange or placement of implants, oncoplastic mastopexy, and concomitant contralateral augmentation mastopexy for symmetry. Patients undergoing lumpectomy for breast conservation as outpatients were identified via retrospective chart review at a high volume private academic affiliated community-based cancer center. Patients with ptosis and either pre-existing breast implants or insufficient breast volume undergoing oncoplastic implant placement (or exchange) and mastopexy were included in the study. Operative details, aesthetic outcomes, and complications were assessed. Results: Over a continuous three-year period, with a two-surgeon cohort, 30 consecutive patients (56 breasts, 4 unilateral procedures) were identified. Patients had an average age of 52.5 years and an average BMI of 27.5, with 40% smokers or former smokers. The average operative time was 2.5 hours, the average implant size removed was 352 cc, and the average implant size placed was 300 cc. All new implants were smooth silicone, with the majority (92%) placed in a retropectoral fashion. 40% of patients received chemotherapy, and 80% of patients received whole breast adjuvant photon radiotherapy with a total radiation dose of either 42.56 or 52.56 Gy. The average and median length of follow-up were both 8.2 months. Of the 24 patients that received radiotherapy, 21% had asymmetry due to capsular contracture. A total of 7 patients (29.2%) underwent revisions for either positive margins (12.5%), capsular contracture (8.3%), implant loss (4.2%), or cosmetic concerns (4.2%). One patient developed a pulmonary embolism in the acute postoperative period and was treated with anticoagulant therapy. Conclusion: Oncoplastic augmentation mastopexy is a safe technique with good aesthetic outcomes and acceptable complication rates for ptotic patients with breast cancer and a paucity of breast volume or pre-existing implants who wish to pursue breast-conserving therapy. The revision rates compare favorably with single-stage cosmetic augmentation procedures as well as other oncoplastic techniques described in the literature. The short-term capsular contracture rates seem lower than the rates in patients undergoing radiation after mastectomy and implant-based reconstruction. Long term capsular contractures and revision rates are too early to know in this cohort.

Keywords: breast conserving therapy, oncoplastic augmentation mastopexy, capsular contracture, breast reconstruction

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Authors: Roxana Maria Angelescu, Doina Răducanu, Mariana Lucia Angelescu, Ion Cincă, Vasile Dănuţ Cojocaru, Cosmin Cotruț, Şerban Nicolae

Abstract:

Titanium alloys are often used for biomedical applications as hard tissue replacements, such as: orthopedic implants, spinal fixation devices and dental implants. Their advantages are well known and demonstrated: excellent mechanical properties, biocompatibility and good corrosion resistance, but it is also known that the main disadvantage of the metallic materials is their tendency of corrosion in in-vivo environments. In 1987, titanium was found to be the only metallic biomaterial that osseointegrates. The aim of this study was to investigate the microstructure and the corrosion behavior of the Ti-20Nb-5Ta wt% alloy. In this case Nb stabilizes the β-Ti structure and Ta is a highly passivating metal. The as studied alloy was melt under argon protective atmosphere in a levitation induction melting furnace, type FIVE CELES - MP25, with a nominal power of 25 kW and a melting capacity of 30 cm3. The microstructure of the as studied alloy was analyzed by using the electronic microscope Tescan Vega II-XMU. The phase structure of the as studied alloy was determined, as well as the crystalline grain size (100-200µ). To determine the corrosion behavior of the as studied alloy, the technique used was the linear polarization, with the PARSTAT 4000 potentiostat, produced by Princeton Applied Research; potentiodynamic curves were obtained with the VeraStudio v.2.4.2 software.

Keywords: corrosion resistance, microstructure, titanium alloys

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Authors: Yung-Shan Lu, Chia-Fone Lee, Shang-Hsuan Li, Chien-Hao Liu

Abstract:

Recently, various bioelectronic devices have been developed for neurologic disease treatments via electro-stimulations such as cochlear implants and retinal prosthesis. Since the electric signal needs electrodes to be transmitted to an organism, electrodes play an important role of stimulations. The materials of stimulation electrodes affect the efficiency of the delivered currents. The higher the efficiency of the electrodes, the lower the threshold current can be used to stimulate the organism which minimizes the potential damages to the adjacent tissues. In this study, we proposed a biocompatible composite electrode composed of high-charge-capacity iridium oxide (IrOₓ) film for a bone-guide extra-cochlear implant. IrOₓ was exploited to decrease the threshold current due to its high capacitance and low impedance. The IrOₓ electrode was fabricated via microelectromechanical systems (MEMS) photolithography and examined with in-vivo tests with guinea pigs. Based on the measured responses of brain waves to sound, the results demonstrated that IrOₓ electrodes have a lower threshold current compared with the Platinum (Pt) electrodes. The research results are expected to be beneficial for implantable and biocompatible electrodes for electrical stimulations.

Keywords: cochlear implants, electrode, electrical stimulation, iridium oxide

Procedia PDF Downloads 159