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Prosthetic socket, Interface pressures, Rapid prototyping, Gait analysis, Medical technology, and R855-855.5

Abstract Background In the past, manufacture of prosthetic socket by using traditional handmade method not only consumed research time but also required a special assembly approach. Recently, reverse engineering and rapid prototype technology have grown up explosively, and thus, provide a choice to fabricate prosthetic socket. Methods Application 3D computer aided design and manufacturing (computer-aided design/computer-aided engineering) tools approach the surface shape stump data is digitized and can be easily modified and reused. Collocation investigates gait parameters of prosthetic socket, and interface stress between stump and socket with different processing conditions. Meanwhile, questionnaire was utilized to survey satisfaction rating scale, comfort level, of subjects using this kind of artificial device. Results The main outcome of current research including gait parameters, stress interface and satisfaction rating scale those would be an informative reference for further studies in design and manufacture as well as clinical applications of prosthetic sockets. Conclusions This study found that, regardless of the method used for socket fabrication, most stress was concentrated in tibia end pressure-relief area. This caused discomfort in the area of tibia end to the participant wearing prosthesis. This discomfort was most evident in case when the prosthetic socket was fabricated using RE and RP.

Background: Three-dimensional (3D) printing is a promising technology, but the limitations are often poorly understood. We compare different 3D printing methods with conventional machining techniques in manufacturing meatal urethral dilators which were recently removed from the Australian market.
Methods: A prototype dilator was 3D printed vertically orientated on a low-cost fused deposition modelling (FDM) 3D printer in polylactic acid (PLA) and acrylonitrile butadiene styrene (ABS). It was also 3D printed horizontally orientated in ABS on a high-end FDM 3D printer with soluble support material, as well as on an SLS 3D printer in medical nylon. The dilator was also machined in stainless steel using a lathe. All dilators were tested mechanically in a custom rig by hanging calibrated weights from the handle until the dilator snapped.
Results: The horizontally printed ABS dilator experienced failure at a greater load than the vertically printed PLA and ABS dilators, respectively (503 g vs 283 g vs 163 g, p < 0.001). The SLS nylon dilator and machined steel dilator did not fail. The steel dilator is the most expensive with a quantity of five at 98 USD each, but this decreases to 30 USD each for a quantity of 1000. In contrast, the cost for the SLS dilator is 33 USD each for five and 27 USD each for 1000.
Conclusions: Low-cost FDM 3D printing is not a replacement for conventional manufacturing. 3D printing is best used for patient-specific parts, prototyping or manufacturing complex parts that have additional functionality that cannot otherwise be achieved.

3T3 Cells, Animals, Anti-Bacterial Agents toxicity, Cell Adhesion drug effects, Cell Proliferation drug effects, Hydrogen-Ion Concentration, Mice, Polylactic Acid-Polyglycolic Acid Copolymer toxicity, Tissue Scaffolds chemistry, Anti-Bacterial Agents chemistry, Anti-Bacterial Agents pharmacology, Magnesium chemistry, Materials Testing, Polylactic Acid-Polyglycolic Acid Copolymer chemistry, and Polylactic Acid-Polyglycolic Acid Copolymer pharmacology

Background: Bone defects are often combined with the risk of infection in the clinic, and artificial bone substitutes are often implanted to repair the defective bone. However, the implant materials are carriers for bacterial growth, and biofilm can form on the implant surface, which is difficult to eliminate using antibiotics and the host immune system. Magnesium (Mg) was previously reported to possess antibacterial potential.
Methods: In this study, Mg was incorporated into poly(lactide-co-glycolic acid) (PLGA) to fabricate a PLGA/Mg scaffold using a low-temperature rapid-prototyping technique. All scaffolds were divided into three groups: PLGA (P), PLGA/10 wt% Mg with low Mg content (PM-L) and PLGA/20 wt% Mg with high Mg content (PM-H). The degradation test of the scaffolds was conducted by immersing them into the trihydroxymethyl aminomethane-hydrochloric acid (Tris-HCl) buffer solution and measuring the change of pH values and concentrations of Mg ions. The antibacterial activity of the scaffolds was investigated by the spread plate method, tissue culture plate method, scanning electron microscopy and confocal laser scanning microscopy. Additionally, the cell attachment and proliferation of the scaffolds were evaluated by the cell counting kit-8 (CCK-8) assay using MC3T3-E1 cells.
Results: The Mg-incorporated scaffolds degraded and released Mg ions and caused an increase in the pH value. Both PM-L and PM-H inhibited bacterial growth and biofilm formation, and PM-H exhibited higher antibacterial activity than PM-L after incubation for 24 and 48 h. Cell tests revealed that PM-H exerted a suppressive effect on cell attachment and proliferation.
Conclusions: These findings demonstrated that the PLGA/Mg scaffolds possessed favorable antibacterial activity, and a higher content of Mg (20%) exhibited higher antibacterial activity and inhibitory effects on cell attachment and proliferation than low Mg content (10%).

Elastic Modulus, Materials Testing, Pressure, Printing, Three-Dimensional, Reproducibility of Results, Stress, Mechanical, Tensile Strength, Time Factors, Balloon Valvuloplasty instrumentation, Finite Element Analysis, Mechanical Phenomena, Patient-Specific Modeling, and Phantoms, Imaging

Background: Patient-specific simulations can provide insight into the mechanics of cardiovascular procedures. Amongst cardiovascular devices, non-compliant balloons are used in several minimally invasive procedures, such as balloon aortic valvuloplasty. Although these balloons are often included in the computer simulations of these procedures, validation of the balloon behaviour is often lacking. We therefore aim to create and validate a computational model of a valvuloplasty balloon.
Methods: A finite element (FE) model of a valvuloplasty balloon (Edwards 9350BC23) was designed, including balloon geometry and material properties from tensile testing. Young's Modulus and distensibility of different rapid prototyping (RP) rubber-like materials were evaluated to identify the most suitable compound to reproduce the mechanical properties of calcified arteries in which such balloons are likely to be employed clinically. A cylindrical, simplified implantation site was 3D printed using the selected material and the balloon was inflated inside it. The FE model of balloon inflation alone and its interaction with the cylinder were validated by comparison with experimental Pressure-Volume (P-V) and diameter-Volume (d-V) curves.
Results: Root mean square errors (RMSE) of pressure and diameter were RMSE P = 161.98 mmHg (3.8 % of the maximum pressure) and RMSE d = 0.12 mm (<0.5 mm, within the acquisition system resolution) for the balloon alone, and RMSE P = 94.87 mmHg (1.9 % of the maximum pressure) and RMSE d = 0.49 mm for the balloon inflated inside the simplified implantation site, respectively.
Conclusions: This validated computational model could be used to virtually simulate more realistic valvuloplasty interventions.

Magnesium, Antibacterial activity, Poly(lactide-co-glycolic acid), Infection, Scaffold, Medical technology, and R855-855.5

Abstract Background Bone defects are often combined with the risk of infection in the clinic, and artificial bone substitutes are often implanted to repair the defective bone. However, the implant materials are carriers for bacterial growth, and biofilm can form on the implant surface, which is difficult to eliminate using antibiotics and the host immune system. Magnesium (Mg) was previously reported to possess antibacterial potential. Methods In this study, Mg was incorporated into poly(lactide-co-glycolic acid) (PLGA) to fabricate a PLGA/Mg scaffold using a low-temperature rapid-prototyping technique. All scaffolds were divided into three groups: PLGA (P), PLGA/10 wt% Mg with low Mg content (PM-L) and PLGA/20 wt% Mg with high Mg content (PM-H). The degradation test of the scaffolds was conducted by immersing them into the trihydroxymethyl aminomethane–hydrochloric acid (Tris–HCl) buffer solution and measuring the change of pH values and concentrations of Mg ions. The antibacterial activity of the scaffolds was investigated by the spread plate method, tissue culture plate method, scanning electron microscopy and confocal laser scanning microscopy. Additionally, the cell attachment and proliferation of the scaffolds were evaluated by the cell counting kit-8 (CCK-8) assay using MC3T3-E1 cells. Results The Mg-incorporated scaffolds degraded and released Mg ions and caused an increase in the pH value. Both PM-L and PM-H inhibited bacterial growth and biofilm formation, and PM-H exhibited higher antibacterial activity than PM-L after incubation for 24 and 48 h. Cell tests revealed that PM-H exerted a suppressive effect on cell attachment and proliferation. Conclusions These findings demonstrated that the PLGA/Mg scaffolds possessed favorable antibacterial activity, and a higher content of Mg (20%) exhibited higher antibacterial activity and inhibitory effects on cell attachment and proliferation than low Mg content (10%).

Body Height, Body Weight, Computer-Aided Design, Humans, Movement, Prosthesis Design methods, Robotics instrumentation, Ultrasonics instrumentation, and Wrist physiology

Background: The design and performance of a new development prosthesis system known as biomechatronics wrist prosthesis is presented in this paper. The prosthesis system was implemented by replacing the Bowden tension cable of body powered prosthesis system using two ultrasonic sensors, two servo motors and microcontroller inside the prosthesis hand for transradial user.
Methods: The system components and hand prototypes involve the anthropometry, CAD design and prototyping, biomechatronics engineering together with the prosthetics. The modeler construction of the system develop allows the ultrasonic sensors that are placed on the shoulder to generate the wrist movement of the prosthesis. The kinematics of wrist movement, which are the pronation/supination and flexion/extension were tested using the motion analysis and general motion of human hand were compared. The study also evaluated the require degree of detection for the input of the ultrasonic sensor to generate the wrist movements.
Results: The values collected by the vicon motion analysis for biomechatronics prosthesis system were reliable to do the common tasks in daily life. The degree of the head needed to bend to give the full input wave was about 45°-55° of rotation or about 14 cm-16 cm. The biomechatronics wrist prosthesis gave higher degree of rotation to do the daily tasks but did not achieve the maximum degree of rotation.
Conclusion: The new development of using sensor and actuator in generating the wrist movements will be interesting for used list in medicine, robotics technology, rehabilitations, prosthetics and orthotics.

Hydrodynamics, Microfluidic Analytical Techniques, Sunflower Oil, Drug Carriers chemistry, Microbubbles, and Plant Oils chemistry

Background: Micro bubbles were initially introduced as contrast agents for ultrasound examinations as they are able to modify the signal-to-noise ratio in imaging, thus improving the assessment of clinical information on human tissue. Recent developments have demonstrated the feasibility of using these bubbles as drug carriers in localized delivery. In micro fluidics devices for generation of micro bubbles, the bubbles are formed at interface of liquid gas through a strangulation process. A device that uses these features can produce micro bubbles with small size dispersion in a single step.
Methods: A T-junction micro fluidic device constructed using 3D prototyping was made for the production of mono dispersed micro bubbles. These micro bubbles use sunflower oil as a lipid layer. Stability studies for micro bubbles with diameters different generated from a liquid phase of the same viscosity were conducted to evaluate whether micro bubbles can be used as drug carriers. The biocompatibility of coating layer, the ability to withstand environmental pressure variations combined with echogenicity, are key factors that they can safely play the role of drug transporters.
Results: The normal distribution curve with small dispersion of the diameter of bubbles validates the process of generating micro bubbles with low value of variation coefficient, i.e., 0.381 at 1.90%. The results also showed the feasibility of using sunflower oil as the lipid matrix with stable population of bubbles over 217 minutes for micro bubbles with an average diameter of 313.04 μm and 121 minutes for micro bubbles with an average diameter of 73.74 μm, considering bubbles with air as gaseous phase.
Conclusion: The results indicate that the micro fluidic device designed can be used for producing micro bubbles with low variation coefficient using sunflower oil as a coating of micro bubbles. These carriers were stable for periods of time that are long enough for clinical applications even when regular air is used as the gas phase. Improved stability can be achieved when biocompatible gas with lower permeability is used.

Bone Diseases, Developmental, Bone Nails, Bone Plates, Cerebral Palsy complications, Child, Femur surgery, Fracture Fixation, Intramedullary methods, Humans, Male, Materials Testing, Osteotomy methods, Cerebral Palsy diagnosis, Fracture Fixation, Intramedullary instrumentation, Internal Fixators, and Osteotomy instrumentation

Background: Rotational osteotomy is frequently indicated to correct excessive femoral anteversion in cerebral palsy patients. Angled blade plate is the standard fixation device used when performed in the proximal femur, but extensile exposure is required for plate accommodation. The authors developed a short locked intramedullary nail to be applied percutaneously in the fixation of femoral rotational osteotomies in children with cerebral palsy and evaluated its mechanical properties.
Methods: The study was divided into three stages. In the first part, a prototype was designed and made based on radiographic measurements of the femoral medullary canal of ten-year-old patients. In the second, synthetic femoral models based on rapid-prototyping of 3D reconstructed images of patients with cerebral palsy were obtained and were employed to adjust the nail prototype to the morphological changes observed in this disease. In the third, rotational osteotomies were simulated using synthetic femoral models stabilized by the nail and by the AO-ASIF fixed-angle blade plate. Mechanical testing was done comparing both devices in bending-compression and torsion.
Results: The authors observed proper adaptation of the nail to normal and morphologically altered femoral models, and during the simulated osteotomies. Stiffness in bending-compression was significantly higher in the group fixed by the plate (388.97 ± 57.25 N/mm) than in that fixed by the nail (268.26 ± 38.51 N/mm) as torsional relative stiffness was significantly higher in the group fixed by the plate (1.07 ± 0.36 Nm/°) than by the nail (0.35 ± 0.13 Nm/°).
Conclusions: Although the device presented adequate design and dimension to fit into the pediatric femur, mechanical tests indicated that the nail was less stable than the blade plate in bending-compression and torsion. This may be a beneficial property, and it can be attributed to the more flexible fixation found in intramedullary devices.

Adult, Amputation Stumps, Biomechanical Phenomena, Female, Gait Analysis, Humans, Male, Pain etiology, Pain prevention control, Pressure, Prosthesis Design instrumentation, Stress, Mechanical, Patient Comfort, and Prosthesis Design methods

Background: In the past, manufacture of prosthetic socket by using traditional handmade method not only consumed research time but also required a special assembly approach. Recently, reverse engineering and rapid prototype technology have grown up explosively, and thus, provide a choice to fabricate prosthetic socket.
Methods: Application 3D computer aided design and manufacturing (computer-aided design/computer-aided engineering) tools approach the surface shape stump data is digitized and can be easily modified and reused. Collocation investigates gait parameters of prosthetic socket, and interface stress between stump and socket with different processing conditions. Meanwhile, questionnaire was utilized to survey satisfaction rating scale, comfort level, of subjects using this kind of artificial device.
Results: The main outcome of current research including gait parameters, stress interface and satisfaction rating scale those would be an informative reference for further studies in design and manufacture as well as clinical applications of prosthetic sockets.
Conclusions: This study found that, regardless of the method used for socket fabrication, most stress was concentrated in tibia end pressure-relief area. This caused discomfort in the area of tibia end to the participant wearing prosthesis. This discomfort was most evident in case when the prosthetic socket was fabricated using RE and RP.

Medical technology and R855-855.5

Abstract Background Rotational osteotomy is frequently indicated to correct excessive femoral anteversion in cerebral palsy patients. Angled blade plate is the standard fixation device used when performed in the proximal femur, but extensile exposure is required for plate accommodation. The authors developed a short locked intramedullary nail to be applied percutaneously in the fixation of femoral rotational osteotomies in children with cerebral palsy and evaluated its mechanical properties. Methods The study was divided into three stages. In the first part, a prototype was designed and made based on radiographic measurements of the femoral medullary canal of ten-year-old patients. In the second, synthetic femoral models based on rapid-prototyping of 3D reconstructed images of patients with cerebral palsy were obtained and were employed to adjust the nail prototype to the morphological changes observed in this disease. In the third, rotational osteotomies were simulated using synthetic femoral models stabilized by the nail and by the AO-ASIF fixed-angle blade plate. Mechanical testing was done comparing both devices in bending-compression and torsion. Results The authors observed proper adaptation of the nail to normal and morphologically altered femoral models, and during the simulated osteotomies. Stiffness in bending-compression was significantly higher in the group fixed by the plate (388.97 ± 57.25 N/mm) than in that fixed by the nail (268.26 ± 38.51 N/mm) as torsional relative stiffness was significantly higher in the group fixed by the plate (1.07 ± 0.36 Nm/°) than by the nail (0.35 ± 0.13 Nm/°). Conclusions Although the device presented adequate design and dimension to fit into the pediatric femur, mechanical tests indicated that the nail was less stable than the blade plate in bending-compression and torsion. This may be a beneficial property, and it can be attributed to the more flexible fixation found in intramedullary devices.