Bio-Medical Materials and Engineering - Volume 33, issue 3

Authors: Takeuchi, Issei | Kimura, Yukie | Nakajima, Takehisa | Makino, Kimiko

Article Type: Research Article

Abstract: BACKGROUND: Inhalable nanocomposite particles using O/W emulsions were studied. The effect of the composition of the dispersed phase on the nanoparticles in the nanocomposite particles was reported, however, the effect on the inhalation characteristics of nanocomposite particles has not been investigated. OBJECTIVE: The aim of this study was to study the effects of lower alcohols in the dispersed phase of O/W emulsions on inhalable nanocomposite particles. METHODS: Nanocomposite particles were prepared using a spray dryer from O/W emulsion. A mixed solution of dichloromethane and lower alcohols in which rifampicin (RFP) and poly(L-lactide-co -glycolide) were dissolved was …used as a dispersed phase, and an aqueous solution in which arginine and leucine were dissolved was used as a continuous phase. RESULTS: We succeeded in preparing non-spherical nanocomposite particles with an average diameter of 9.01–10.91 μm. The results of the fine particle fraction (FPF) measurement showed that the higher the hydrophobicity of the lower alcohol mixed in the dispersed phase, the higher the FPF value. The FPF value of the nanocomposite particles was significantly increased by using ethanol and 1-propanol. CONCLUSIONS: The results were revealed that mixing 1-propanol with the dispersed phase increased the amount of RFP delivered to the lungs. Show more

Keywords: Nanocomposite particles, poly(L-lactide-co-glycolide), inhalation, lower alcohols, fine particle fraction

DOI: 10.3233/BME-211244

Citation: Bio-Medical Materials and Engineering, vol. 33, no. 3, pp. 159-168, 2022

Authors: Rahman, Waseem Ur | Jiang, Wei | Wang, Guohua | Li, Zhijun

Article Type: Research Article

Abstract: BACKGROUND: The finite element method (FEM) is an efficient and powerful tool for studying human spine biomechanics. OBJECTIVE: In this study, a detailed asymmetric three-dimensional (3D) finite element (FE) model of the upper cervical spine was developed from the computed tomography (CT) scan data to analyze the effect of ligaments and facet joints on the stability of the upper cervical spine. METHODS: A 3D FE model was validated against data obtained from previously published works, which were performed in vitro and FE analysis of vertebrae under three types of loads, i.e. flexion/extension, axial rotation, and lateral …bending. RESULTS: The results show that the range of motion of segment C1–C2 is more flexible than that of segment C2–C3. Moreover, the results from the FE model were used to compute stresses on the ligaments and facet joints of the upper cervical spine during physiological moments. CONCLUSION: The anterior longitudinal ligaments (ALL) and interspinous ligaments (ISL) are found to be the most active ligaments, and the maximum stress distribution is appear on the vertebra C3 superior facet surface under both extension and flexion moments. Show more

Keywords: Asymmetric, ligaments, facet joint, finite element, upper cervical spine

DOI: 10.3233/BME-211247

Citation: Bio-Medical Materials and Engineering, vol. 33, no. 3, pp. 169-181, 2022

Authors: Otsuka, Yuta | Pal, Suvra

Article Type: Research Article

Abstract: BACKGROUND: Control of the pharmaceutical manufacturing process and active pharmaceutical ingredients (API) is essential to product formulation and bioavailability. OBJECTIVE: The aim of this study is to predict tablet surface API concentration by chemometrics using integrating sphere UV-Vis spectroscopy, a non-destructive and contact-free measurement method. METHODS: Riboflavin, pyridoxine hydrochloride, dicalcium phosphate anhydrate, and magnesium stearate were mixed and ground with a mortar and pestle, and 100 mg samples were subjected to direct compression at a compaction pressure of 6 MPa at 7 mm diameter. The flat surface tablets were then analyzed by integrating sphere UV-Vis spectrometry. Standard normal variate …(SNV) normalization and principal component analysis were applied to evaluate the measured spectral dataset. The spectral ranges were prepared at 300–800 nm and 500–700 nm with SNV normalization. Partial least squares (PLS) regression models were constructed to predict the API concentrations based on two previous datasets. RESULTS: The regression vector of constructed PLS regression models for each API was evaluated. API concentration prediction depends on riboflavin absorbance at 550 nm and the excipient dicalcium phosphate anhydrate. CONCLUSION: Integrating sphere UV-Vis spectrometry is a useful tool to process analytical technology. Show more

Keywords: Integrating sphere UV-Vis spectroscopy, chemometrics, process analytical technology, partial least squares, multivariate analysis

DOI: 10.3233/BME-211269

Citation: Bio-Medical Materials and Engineering, vol. 33, no. 3, pp. 183-194, 2022

Authors: Koh, Yong-Gon | Lee, Jin-Ah | Lee, Hwa-Yong | Suh, Dong-Suk | Park, Joon-Hee | Kang, Kyoung-Tak

Article Type: Research Article

Abstract: BACKGROUND: Recently, there has been an increasing interest in mobile-bearing total knee arthroplasty (TKA). However, changes in biomechanics for femoral component alignment in mobile-bearing TKA have not been explored in depth. OBJECTIVE: This study aims to evaluate the biomechanical effect of sagittal alignment of the femoral component in mobile-bearing TKA. METHODS: We developed femoral sagittal alignment models with −3°, 0°, 3°, 5°, and 7° flexion. We also examine the kinematics of the tibiofemoral (TF) joint, contact point on the TF joint, contact stress on the patellofemoral (PF) joint, collateral ligament force, and quadriceps force using a …validated computational model under a deep-knee-bend condition. RESULTS: Posterior kinematics of the TF joint increases as the femoral component flexes. The contact stress on the PF joint, collateral ligament force, and the quadriceps force decreases as the femoral component flexes. CONCLUSIONS: Our results show that a slight, approximately 0°∼3°, flexion of the implantation could be an effective substitute technique. However, excessive flexion should be avoided because of the potential loosening of the TF joint. Show more

Keywords: Total knee arthroplasty, mobile-bearing, misalignment, finite element analysis

DOI: 10.3233/BME-211280

Citation: Bio-Medical Materials and Engineering, vol. 33, no. 3, pp. 195-207, 2022

Authors: Sun, Hongyu | Wang, Yuefei | Sun, Chu | Yu, Haiming | Xi, Zheng | Liu, Na | Zhang, Nan

Article Type: Research Article

Abstract: BACKGROUND: Magnesium (Mg) alloy have biodegradation and mechanical properties that are similar to those of human bone, making it a promising candidate material for inclusion in implantable medical devices. OBJECTIVE: The osteointegration effect of Mg alloy scaffolds with different corrosion rates were studied and evaluated in large bone defect models. METHOD: Mg–Sr and Mg–Ca alloy scaffolds with a 20-μm Micro-arc oxidation (MAO) coating were used to repair critical bone defects for subsequent assessment of each alloy’s degradation and osteointegration by X-ray, Micro-CT, fluorescence and histological examination. RESULTS: At 12 weeks post-implantation, each defect was …found to be effectively reconstructed by either of the Mg alloys based on X-ray and Micro-CT images. The corrosion rate (CR) of each Mg alloy – as calculated based on micro-computed tomography information – demonstrated that the MAO coating could provide effective protection for only 4 weeks post-surgery. From weeks 8 to 12, the CR of the Mg–Ca alloy scaffold increased from 1.34 ± 0.23 mm/y to 1.57 ± 0.16 mm/y. In contrast, the CR of the Mg–Sr alloy scaffold decreased from 0.58 ± 0.14 mm/y to 0.54 ± 0.16 mm/y. However, fluorescence and histological examination revealed more mature, closely and regularly arranged newborn osteocytes at the Mg–Ca scaffold-fracture interface e from weeks 8 to 12 after surgery. CONCLUSION: The Mg–Sr scaffold was more corrosion resistant and the Mg–Ca scaffold yielded a better overall repair, which indicates that the CR of magnesium alloys matches the rate of new bone formation and is the key to repair bone defects as a bone substitute. Show more

Keywords: Micro-arc oxidation (MAO), Mg alloy scaffold, degradation, osteointegration

DOI: 10.3233/BME-211300

Citation: Bio-Medical Materials and Engineering, vol. 33, no. 3, pp. 209-219, 2022

Authors: de França Silva Azevedo, Ana Clara | Morúa, Otto Cumberbatch | de Lima, Gabriel Goetten | da Silva, Henrique Nunes | da Silva Ferreira, Jefferson | Fook, Marcus Vinicius Lia | de Sá, Marcelo Jorge Cavalcanti

Article Type: Research Article

Abstract: BACKGROUND: Bone cements aid in bone regeneration; however, if the handling time is not well established for the material to harden, complications may arise. OBJECTIVE: This work investigates the effect of using polyethylene glycol (PEG) and characterize it in brushite bone cement in order to obtain desirable handling times as well as its regeneration in vivo to analyse if addition of this polymer may significantly modify its properties. METHODS: PEG 4000 was synthesised with wollastonite by phosphorization reaction in order to form brushite which was further cured by oven drying. They were further characterised and tested …in vivo as tibial bone defect model using rabbits. RESULTS: Addition of PEG exhibited handling times of 60 min with a low increase in temperature when curing. Brushite phase of ∼71% was obtained after cement hardening with good compressive strength (25 MPa) and decent values of porosity (33%). In vivo presented that, at 40 days postoperatively, accelerated bone neoformation with partial consolidation at 30 days and total after 60 days when using bone cement. CONCLUSIONS: Addition of PEG does not disrupt the beneficial properties of the bone cement and can be a potential alternative to control the time-temperature profile of hardening these materials. Show more

Keywords: Biomaterials, bone healing, fractures, grafts

DOI: 10.3233/BME-211308

Citation: Bio-Medical Materials and Engineering, vol. 33, no. 3, pp. 221-233, 2022

Authors: Wu, Keyan | Lang, Xun | Zhang, Yufeng | Li, Zhiyao | He, Bingbing | Gao, Lian | Chen, Jianhua

Article Type: Research Article

Abstract: BACKGROUND: Considerable progress of ultrasound simulation on blood has enhanced the characterizing of red blood cell (RBC) aggregation. OBJECTIVE: A novel simulation method aims at modeling the blood with different RBC aggregations and concentrations is proposed. METHODS: The modeling process is as follows: (i) A three-dimensional scatterer model is first built by a mapping with a Hilbert space-filling curve from the one-dimensional scatterer distribution. (ii) To illustrate the relationship between the model parameters and the RBC aggregation level, a variety of blood samples are prepared and scanned to acquire their radiofrequency signals in-vitro . (iii) The …model parameters are determined by matching the Nakagami-distribution characteristics of envelope signals simulated from the model with those measured from the blood samples. RESULTS: Nakagami metrics m estimated from 15 kinds of blood samples (hematocrits of 20%, 40%, 60% and plasma concentrations of 15%, 30%, 45%, 60%, 75%) are compared with metrics estimated by their corresponding models (each with different eligible parameters). Results show that for the three hematocrit levels, the mean and standard deviation of the root-mean-squared deviations of m are 0.27 ± 0.0026, 0.16 ± 0.0021, 0.12 ± 0.0018 respectively. CONCLUSION: The proposed simulation model provides a viable data source to evaluate the performance of the ultrasound-based methods for quantifying RBC aggregation. Show more

Keywords: RBC aggregation, quantitative ultrasound, envelope statistics, Nakagami distribution, ultrasonic model

DOI: 10.3233/BME-211340

Citation: Bio-Medical Materials and Engineering, vol. 33, no. 3, pp. 235-257, 2022