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Biomechanical origins of inherent tension in fibrin networks. 纤维蛋白网络固有张力的生物力学起源。
Pub Date : 2022-06-01 DOI: 10.2139/ssrn.4097566
Russell Spiewak, A. Gosselin, Danil Merinov, R. Litvinov, J. Weisel, Valerie Tutwiler, P. Purohit
Blood clots form at the site of vascular injury to seal the wound and prevent bleeding. Clots are in tension as they perform their biological functions and withstand hydrodynamic forces of blood flow, vessel wall fluctuations, extravascular muscle contraction and other forces. There are several mechanisms that generate tension in a blood clot, of which the most well-known is the contraction/retraction caused by activated platelets. Here we show through experiments and modeling that clot tension is generated by the polymerization of fibrin. Our mathematical model is built on the hypothesis that the shape of fibrin monomers having two-fold symmetry and off-axis binding sites is ultimately the source of inherent tension in individual fibers and the clot. As the diameter of a fiber grows during polymerization the fibrin monomers must suffer axial twisting deformation so that they remain in register to form the half-staggered arrangement characteristic of fibrin protofibrils. This deformation results in a pre-strain that causes fiber and network tension. Our results for the pre-strain in single fibrin fibers is in agreement with experiments that measured it by cutting fibers and measuring their relaxed length. We connect the mechanics of a fiber to that of the network using the 8-chain model of polymer elasticity. By combining this with a continuum model of swellable elastomers we can compute the evolution of tension in a constrained fibrin gel. The temporal evolution and tensile stresses predicted by this model are in qualitative agreement with experimental measurements of the inherent tension of fibrin clots polymerized between two fixed rheometer plates. These experiments also revealed that increasing thrombin concentration leads to increasing internal tension in the fibrin network. Our model may be extended to account for other mechanisms that generate pre-strains in individual fibers and cause tension in three-dimensional proteinaceous polymeric networks.
血管损伤部位会形成血块,以密封伤口并防止出血。凝块在发挥其生物功能并承受血液流动、血管壁波动、血管外肌肉收缩和其他力的流体动力时处于紧张状态。有几种机制会在血栓中产生张力,其中最著名的是活化血小板引起的收缩/回缩。在这里,我们通过实验和建模表明,血栓张力是由纤维蛋白的聚合产生的。我们的数学模型建立在这样一个假设之上,即具有双重对称性和离轴结合位点的纤维蛋白单体的形状最终是单个纤维和凝块中固有张力的来源。随着纤维直径在聚合过程中的增长,纤维蛋白单体必须经历轴向扭曲变形,以便它们保持对齐,以形成纤维蛋白原纤维的半交错排列特征。这种变形导致预应变,从而导致纤维和网络张力。我们对单个纤维蛋白纤维预应变的结果与通过切割纤维和测量其松弛长度来测量预应变的实验一致。我们使用聚合物弹性的8链模型将纤维的力学与网络的力学联系起来。通过将其与可膨胀弹性体的连续体模型相结合,我们可以计算受约束纤维蛋白凝胶中张力的演变。该模型预测的时间演变和拉伸应力与两个固定流变仪板之间聚合的纤维蛋白凝块固有张力的实验测量结果在质量上一致。这些实验还表明,增加凝血酶浓度会导致纤维蛋白网络中的内部张力增加。我们的模型可以扩展到解释在单个纤维中产生预应变并在三维蛋白质聚合物网络中引起张力的其他机制。
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引用次数: 5
Identification of a visco-hyperelastic model for mandibular periosteum. 下颌骨膜粘弹性模型的鉴定。
Pub Date : 2022-06-01 DOI: 10.2139/ssrn.4093629
Alexandre Hamma, J. Boisson, V. Serantoni, J. Dallard
In this paper, a visco-hyperelastic model representing the mechanical behavior of the human mandibular periosteum as an anisotropic and homogeneous material is identified. Different models, extracted from the literature, are tested and associated in order to describe the elastic and visco-elastic contributions of the cellular matrix on one hand and the collagen fibers on the other hand. The parameters of these models are determined using five human mandibular periosteum. Each harvested sample is cut and tested, at two different velocities, either longitudinally or transversely to collagen fibers main direction. The hyperelastic and visco-elastic contributions of the cellular matrix are extracted using tensile tests performed transversely. The hyperelastic and visco-elastic contributions of the collagen fibers are extracted using tensile tests performed longitudinally. In a second time, the identified combination of models is validated using twelve samples only tested longitudinally. The selected combination uses the simplified Rivlin's 2nd order law to model the hyper-elasticity of the cellular matrix, the Kulkarni's law to model its visco-elasticity contribution, and the Kulkarni's laws to model the whole contributions of collagen fibers.
本文提出了一种表征人类下颌骨膜作为各向异性和均质材料的力学行为的粘-超弹性模型。从文献中提取的不同模型进行了测试和关联,以描述细胞基质和胶原纤维的弹性和粘弹性贡献。这些模型的参数是用5个人类下颌骨膜确定的。每个收获的样品被切割和测试,以两种不同的速度,纵向或横向胶原纤维的主要方向。通过横向拉伸试验提取细胞基质的超弹性和粘弹性贡献。胶原纤维的超弹性和粘弹性贡献是通过纵向拉伸试验提取的。在第二次,识别的模型组合是验证使用12个样本只纵向测试。所选择的组合使用简化的Rivlin二阶定律来模拟细胞基质的超弹性,Kulkarni定律来模拟其粘弹性贡献,Kulkarni定律来模拟胶原纤维的整体贡献。
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引用次数: 0
Analytical model for dental implant insertion torque. 牙种植体插入力矩的解析模型。
Pub Date : 2022-04-14 DOI: 10.2139/ssrn.4034460
Baixuan Yang, A. Irastorza-Landa, P. Heuberger, H. Ploeg
Maximum insertion torque (IT) for threaded dental implants is a primary clinical measurement to assess implant anchorage, and strongly influences the clinical outcome. Insertion torque is influenced by surgical technique, implant designs, and patient factors such as bone density and quality. In this study, an analytical model was proposed for IT to estimate contributions from the thread and taper separately. The purpose of this study was to test if the analytical model could 1. differentiate the parallel-walled and tapered implant; and, 2. represent four factors: bone surrogate density, drill protocol, implant surface finish and cutting flute. The IT was modeled as the sum of the torques from the thread's inclined plane and interface shear stress from the tapered body integrated over the surface area, respectively, with two main parameters: effective force, F', F' and effective pressure, p'. The effective force, relates to the clamping force from the thread, while the effective pressure, p', associates with the contact pressure at the bone-implant interface. The model performed well (R2 = 0.88-1.0) and differentiated between the parallel-walled (p'= 0) and tapered implants (p'= 0.12). The model's parameters could individually represent the effects of the four factors. High bone surrogate density, two-step drill protocol, and rough surface increased both F' and p'. The cutting flute had opposing effects on F' and p' (β4 = 0.35 and -0.24, respectively); and therefore, had the lowest net effect on IT. The proposed analytical model therefore improves the understanding of the principal contributors to dental implant IT by considering thread and taper mechanics independently.
螺纹种植体的最大插入扭矩(IT)是评估种植体支抗的主要临床测量指标,对临床结果有很大影响。植入扭矩受手术技术、植入物设计和患者因素(如骨密度和质量)的影响。在本研究中,提出了一个分析模型,用于IT分别估计螺纹和锥度的贡献。本研究的目的是检验分析模型是否可以。区分平行壁和锥形植入物;, 2。代表四个因素:骨替代物密度,钻孔方案,种植体表面光洁度和切割凹槽。IT模型分别为螺纹斜面扭矩和锥体界面剪应力在表面上的总和,有两个主要参数:有效力F′,F′和有效压力p′。有效作用力与来自螺纹的夹紧力有关,而有效压力p'与骨-种植体界面处的接触压力有关。该模型表现良好(R2 = 0.88-1.0),可区分平行壁种植体(p′= 0)和锥形种植体(p′= 0.12)。模型的参数可以单独代表这四个因素的影响。高骨替代物密度、两步钻孔方案和粗糙表面均可增加F′和p′。切割槽对F′和p′的影响相反(β4分别= 0.35和-0.24);因此,对IT的净影响最低。因此,所提出的分析模型通过独立考虑螺纹和锥度力学,提高了对牙种植体IT的主要贡献者的理解。
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引用次数: 1
Prediction of uniaxial and biaxial flexural strengths of resin-based composites using the Weibull model. 用威布尔模型预测树脂基复合材料的单轴和双轴弯曲强度。
Pub Date : 2022-04-12 DOI: 10.2139/ssrn.4045919
Raluca Ghelbere, N. Ilie
OBJECTIVESThe aim of the study was to assess the applicability of the Weibull model for resin-based composites (RBC) to predict the outcome of different flexural tests based on one another, while identifying the minimal sample number for a precise Weibull representation.METHODSFour RBCs underwent 3-point, 4-point and biaxial flexural testing (n = 480). Fracture surfaces of all specimens were assessed under optical microscope, while fracture modes of the uniaxial specimens were documented. Representative specimens for each fracture mode were further analyzed under scanning electron microscope. Since fracture predominantly originated from a surface flaw, the effective surface was used in the Weibull model. The analysis was performed on 20, then 30 and finally 40 specimens per group to assess the effect of the specimen size. Further statistical analysis was performed through uni- and multivariate ANOVA, Tukey's post hoc test (α = 0.05), and Pearson's correlation.RESULTSThe Weibull model could predict the results of uniaxial tests within the standard deviation, with the correlation between calculated and measured values reaching values of R2 = 0.985 and higher. Predictions for or based on the biaxial tests misestimated the measured values, with a weaker correlation (R2 = 0.875) between measured and calculated flexural strength (FS). The fit of the data to the Weibull distribution improved with rising sample size resulting in better predictions of the FS when n = 40.SIGNIFICANCEThe applicability of the Weibull model on RBCs allows accurate comparison between bending tests and their FS under consideration of the effective surface.
目的本研究的目的是评估树脂基复合材料(RBC)的威布尔模型在预测不同弯曲试验结果方面的适用性,同时确定精确威布尔表示的最小样本数。方法对4个红细胞进行了3点、4点和双轴弯曲试验(n=480)。在光学显微镜下评估所有试样的断裂表面,同时记录单轴试样的断裂模式。在扫描电子显微镜下进一步分析了每种断裂模式的代表性试样。由于断裂主要来源于表面缺陷,因此威布尔模型中使用了有效表面。对每组20个、30个和最后40个样本进行分析,以评估样本大小的影响。通过单因素和多因素方差分析、Tukey事后检验(α=0.05)和Pearson相关性进行进一步的统计分析。结果威布尔模型可以在标准偏差范围内预测单轴试验的结果,计算值和测量值之间的相关性达到R2=0.985或更高。双轴试验或基于双轴试验的预测错误估计了测量值,测量和计算的抗弯强度(FS)之间的相关性较弱(R2=0.875)。数据与威布尔分布的拟合随着样本量的增加而改善,从而在n=40时更好地预测FS。威布尔模型在RBC上的适用性允许在考虑有效表面的情况下准确比较弯曲试验及其FS。
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引用次数: 1
Mechanical properties of polycaprolactone (PCL) scaffolds for hybrid 3D-bioprinting with alginate-gelatin hydrogel. 海藻酸-明胶混合生物3d打印用聚己内酯(PCL)支架的力学性能
Pub Date : 2022-04-01 DOI: 10.2139/ssrn.3962819
F. Koch, Ole Thaden, Stefan Conrad, Kevin Tröndle, G. Finkenzeller, R. Zengerle, Sabrina Kartmann, S. Zimmermann, P. Koltay
The generation of artificial human tissue by 3D-bioprinting has expanded significantly as a clinically relevant research topic in recent years. However, to produce a complex and viable tissue, in-depth biological understanding and advanced printing techniques are required with a high number of process parameters. Here, we systematically evaluate the process parameters relevant for a hybrid bioprinting process based on fused-deposition modeling (FDM) of thermoplastic material and microextrusion of a cell-laden hydrogel. First, we investigated the effect of the printing temperature of polycaprolactone (PCL), on the junction strength between individual fused filaments and on the viability of immortalized mesenchymal stem cells (iMSC) in the surrounding alginate-gelatin-hydrogel. It was found that a printing temperature of 140 °C and bonds with an angle of 90° between the filaments provided a good compromise between bonding strength of the filaments and the viability of the surrounding cells. Using these process parameters obtained from individual fused filaments, we then printed cubic test structures with a volume of 10 × 10 × 10 mm3 with different designs of infill patterns. The variations in mechanical strength of these cubes were measured for scaffolds made of PCL-only as well as for hydrogel-filled PCL scaffolds printed by alternating hybrid bioprinting of PCL and hydrogel, layer by layer. The bare scaffolds showed a compressive modulus of up to 6 MPa, close to human hard tissue, that decreased to about 4 MPa when PCL was printed together with hydrogel. The scaffold design suited best for hybrid printing was incubated with cell-laden hydrogel and showed no degradation of its mechanical strength for up to 28 days.
近年来,利用生物3d打印技术生成人造人体组织作为临床相关的研究课题得到了显著扩展。然而,为了生产一个复杂和可行的组织,深入的生物学理解和先进的打印技术需要大量的工艺参数。在这里,我们系统地评估了基于热塑性材料的熔融沉积建模(FDM)和细胞负载水凝胶的微挤压的混合生物打印工艺的相关工艺参数。首先,我们研究了聚己内酯(PCL)的打印温度对单个融合丝之间连接强度的影响,以及对海藻酸-明胶-水凝胶中永生化间充质干细胞(iMSC)活力的影响。结果表明,当打印温度为140°C,纤维之间的键角为90°时,纤维的键合强度和周围细胞的活力之间得到了很好的平衡。利用从单个熔丝中获得的这些工艺参数,我们打印了体积为10 × 10 × 10 mm3的立方体测试结构,并设计了不同的填充图案。这些立方体的机械强度变化被测量为仅由PCL制成的支架,以及由PCL和水凝胶交替混合生物打印打印的水凝胶填充的PCL支架,一层一层。裸露支架的压缩模量可达6 MPa,接近人体硬组织,与水凝胶一起打印PCL后压缩模量降至4 MPa左右。最适合混合打印的支架设计与细胞负载的水凝胶一起孵育,其机械强度没有下降,长达28天。
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引用次数: 10
Skeletal muscle surrogates for the acquisition of muscle repair skills in upper limb surgery. 骨骼肌替代物在上肢手术中获得肌肉修复技能。
Pub Date : 2022-04-01 DOI: 10.2139/ssrn.3998968
L. Heskin, R. Galvin, Jack Conroy, O. Traynor, Stephen Madden, C. Simms
INTRODUCTIONThe required fidelity of synthetic materials in surgical simulators to teach tissue handling and repair requirements should be as accurate as possible. There is a poor understanding of the relationship between choice of muscle surrogates and training outcome for trainee surgeons. To address this, the mechanical characteristics of several candidate synthetic muscle surrogates were measured, and their subjective biofidelity was qualitatively assessed by surgeons.METHODSSilicone was selected after assessing several material options and 16 silicone-based surrogates were evaluated. Three of the closest samples to muscle (Samples 1.1, 1.2, 1.3) and one with inserted longitudinal fibres (1.2F) were mechanically tested in the following: compression and tension, needle puncture force and suture pull-out in comparison with real muscle. The four samples were evaluated by 17 Plastic and Orthopaedic surgeons to determine their views of the fidelity with regard to the handling properties, needle insertion and ease of suture pull-out.RESULTSThe mechanical testing showed the surrogates exhibited varying characteristics that matched some of the properties of muscle, though none recreated all the mechanical characteristics of native muscle. Good biofidelity was generally achieved for compression stiffness and needle puncture force, but it was evident that tensile stiff was too low for all samples. The pull-out forces were variable and too low, except for the sample with longitudinal fibres. In the qualitative assessment, the overall median scores for the four surrogate samples were all between 30 and 32 (possible range 9-45), indicating limited differentiation of the samples tested by the surgeons.CONCLUSIONSThe surrogate materials showed a range of mechanical properties bracketing those of real muscle, thus presenting a suitable combination of candidates for use in simulators to attain the requirements as set out in the learning outcomes of muscle repair. However, despite significant mechanical differences between the samples, all surgeons found the samples to be similar to each other.
简介外科模拟器中用于教授组织处理和修复要求的合成材料的保真度应尽可能准确。对肌肉替代品的选择与实习外科医生的培训结果之间的关系了解不足。为了解决这一问题,测量了几种候选合成肌肉替代物的机械特性,并由外科医生对其主观生物逼真度进行了定性评估。方法在评估了几种材料选择后选择了硅,并对16种硅基替代物进行了评估。三个最接近肌肉的样本(样本1.1、1.2、1.3)和一个插入纵向纤维的样本(1.2F)在以下方面进行了机械测试:与真实肌肉相比,压缩和张力、针头穿刺力和缝线拉出。17名整形外科医生和整形外科医生对这四个样本进行了评估,以确定他们对处理性能、针头插入和缝线拔出方便性的保真度的看法。结果机械测试表明,替代品表现出不同的特征,与肌肉的一些特性相匹配,尽管没有一个能重现天然肌肉的所有力学特征。压缩刚度和针头穿刺力通常都能获得良好的生物逼真度,但很明显,所有样品的拉伸刚度都太低。拉出力是可变的并且太低,除了具有纵向纤维的样品。在定性评估中,四个替代样本的总体中位得分均在30至32之间(可能在9-45之间),这表明外科医生测试的样本差异有限。结论替代材料显示出一系列与真实肌肉相当的力学性能,从而为模拟器提供了一个合适的候选组合,以达到肌肉修复学习结果中提出的要求。然而,尽管样本之间存在显著的机械差异,但所有外科医生都发现样本彼此相似。
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引用次数: 0
Effects of poloxamer additives on strength, injectability, and shape stability of beta-tricalcium phosphate cement modified using ball-milling. 波洛沙姆外加剂对球磨改性磷酸三钙水泥强度、注射性和形状稳定性的影响。
Pub Date : 2022-03-16 DOI: 10.2139/ssrn.4041128
Y. Kim, E. Uyama, K. Sekine, F. Kawano, K. Hamada
A new CPC was developed in this study using a β-TCP powder mechano-chemically modified by ball-milling. The prototype CPC exhibits excellent fluidity for easy injection into bone defects; however, there is a risk of leakage from the defects immediately after implantation due to its high fluidity. The addition of poloxamer, an inverse thermoresponsive gelling agent, into CPC optimizes the fluidity. At lower temperatures, it forms a sol and maintains good injectability, whereas at the human body temperature, it transforms to a gel, reducing the fluidity and risk of leakage. In this study, the effects of poloxamer addition of 3, 5, and 10 mass% on the injectability, shape stability, and strength of the prototype CPC were evaluated. The calculated injectability of the prototype CPC pastes containing three different poloxamer contents was higher than that of the CPC paste without poloxamer for 15 min at 37 °C. Furthermore, the shape stability immediately after injection of the three CPC pastes with poloxamer was higher than that of the CPC paste without poloxamer. After 1 week of storage at 37 °C, the compressive strength and diametral tensile strength of the CPC compacts containing 10 mass% poloxamer were similar to those of the CPC compact without poloxamer. Additionally, the CPC compacts containing 10 mass% poloxamer exhibited clear plastic deformation after fracture. These results indicate that the addition of poloxamer to the prototype CPC could reduce the risk of leakage from bone defects and improve the fracture toughness with maintaining the injectability and strength.
本研究使用球磨机械化学改性的β-TCP粉末开发了一种新的CPC。CPC原型表现出优异的流动性,易于注射到骨缺损中;然而,由于其高流动性,在植入后立即存在缺陷泄漏的风险。在CPC中加入泊洛沙姆,一种反热响应胶凝剂,可以优化流动性。在较低的温度下,它会形成溶胶并保持良好的可注射性,而在人体温度下,会转化为凝胶,降低流动性和泄漏风险。在本研究中,评估了添加3、5和10质量%的泊洛沙姆对原型CPC的可注射性、形状稳定性和强度的影响。含有三种不同泊洛沙姆含量的原型CPC糊剂在37°C下注射15分钟的计算可注射性高于不含泊洛沙姆的CPC糊剂。此外,三种含有泊洛沙姆的CPC糊剂在注射后立即的形状稳定性高于不含有泊洛沙的CPC糊料。在37°C下储存1周后,含有10质量%泊洛沙姆的CPC压块的抗压强度和径向拉伸强度与不含泊洛沙姆。此外,含有10质量%泊洛沙姆的CPC压块在断裂后表现出明显的塑性变形。这些结果表明,在原型CPC中添加泊洛沙姆可以降低骨缺损渗漏的风险,并在保持可注射性和强度的同时提高骨折韧性。
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引用次数: 2
Effects of material non-symmetry on the mechanical behavior of arterial wall. 材料不对称对动脉壁力学行为的影响。
Pub Date : 2022-03-06 DOI: 10.2139/ssrn.3998969
Hai-Chao Han
Arteries are commonly assumed as symmetric cylindrical tubes with axisymmetric geometry and mechanical properties. However, their wall stress, structure and mechanical properties may become nonsymmetric when subject to torsion or complex mechanical loading. The objective of this study was to explore the nonsymmetric two fiber family constitutive models for arterial walls and examine the impact of this non-symmetry on the deformation and stress in arteries under mechanical loads. Our results demonstrated that nonsymmetric collagen fiber properties and alignment lead to interesting phenomena such as vessel twisting associated with axial stretch or pressurization. There are "magic" nonsymmetric fiber angles at which a vessel would not twist under given pressure and axial stretch. The nonsymmetric fiber properties and alignment (mean angle and dispersion) affects the torque-twist angle relationship as well as the axial stretch and pressurized inflation. These results illustrate the effects of nonsymmetric collagen fiber distribution and suggest that the Holzapfel-Gasser-Ogden models could be generalized to incorporate the nonsymmetric two fiber families for broader applications, especially when there is shear or torsion.
动脉通常被认为是具有轴对称几何形状和机械特性的对称圆柱形管。然而,当受到扭转或复杂的机械载荷时,它们的壁应力、结构和力学性能可能会变得不对称。本研究的目的是探索动脉壁的非对称双纤维族本构模型,并研究这种非对称性对机械载荷下动脉变形和应力的影响。我们的研究结果表明,非对称胶原纤维的特性和排列会导致有趣的现象,如与轴向拉伸或加压相关的血管扭曲。有一些“神奇”的非对称纤维角,在给定的压力和轴向拉伸下,容器不会扭曲。非对称纤维的特性和排列(平均角度和色散)影响扭矩-扭曲角度关系以及轴向拉伸和加压膨胀。这些结果说明了非对称胶原纤维分布的影响,并表明Holzapfel-Gaser-Ogden模型可以推广为包含非对称两种纤维族,以获得更广泛的应用,特别是在存在剪切或扭转时。
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引用次数: 5
Effects of 3D printed surface topography and normal force on implant expulsion. 3D打印表面形貌和法向力对种植体排出的影响。
Pub Date : 2022-03-01 DOI: 10.2139/ssrn.3978782
Amanda Heimbrook, Cambre N. Kelly, K. Gall
3D printing is a critical method for manufacturing metallic implants as it enables direct fabrication of intricate geometries and porous structures inaccessible to other manufacturing methods. Some common 3D printed porous structures are strut based (e.g. octet truss), triply periodic minimal surfaces (TPMS) (e.g. gyroid) or randomized (e.g. stochastic). When designed to be on the surface of bone interfacing implants, the surface porous region impacts short-term adhesion and friction, ultimately affecting implant stability prior to and during long-term osseointegration. In many orthopedic procedures, expulsion resistance is an essential design requirement, to prevent the risk of the implant migrating from the implantation site. While expulsion tests are universal, they are a poorly understood method to examine the bone-implant interface in determining the performance of an orthopedic implant. In this foundational study, we examine the expulsion behavior of metallic samples in synthetic Sawbone with systematically varied surface topography at increasing applied normal forces. The applied normal force and size of the sample were shown to have the strongest influence on expulsion force followed by surface structure. Compared to a polished sample control, certain 3D printed surface structures are up to 10x more expulsion resistant and should be considered in implants where prevention of implant migration before and during osseointegration is critical. Nonlinear relationships were discovered that reveal "crossover" in expulsion resistance as a function of applied load revealing that the ranking of the relative expulsion resistance of different samples can depend on the normal force selected. This new fundamental understanding has broad implications on both the design and potential standardized regulatory testing of textured orthopedic implants with tailored topologies.
3D打印是制造金属植入物的关键方法,因为它可以直接制造复杂的几何形状和其他制造方法无法实现的多孔结构。一些常见的3D打印多孔结构是基于支柱(例如八柱桁架),三周期最小表面(例如陀螺)或随机(例如随机)。当被设计在骨界面种植体的表面时,表面多孔区域会影响短期的粘附和摩擦,最终影响种植体在长期骨整合之前和期间的稳定性。在许多骨科手术中,抗排出性是一个基本的设计要求,以防止植入物从植入部位迁移的风险。虽然排出试验是通用的,但在确定骨科植入物的性能时,它们是一种检查骨-植入物界面的鲜为人知的方法。在这项基础研究中,我们研究了金属样品在合成锯骨中具有系统变化的表面形貌的排样行为,并增加了施加的法向力。结果表明,施加的法向力和样品尺寸对排渣力的影响最大,其次是表面结构。与抛光样品对照相比,某些3D打印表面结构的抗排出性高出10倍,在植入物中应该考虑在骨整合之前和期间防止植入物迁移。研究发现,非线性关系揭示了排阻作为施加载荷的函数的“交叉”,表明不同样品的相对排阻的排名可能取决于所选择的法向力。这一新的基本认识对具有定制拓扑结构的纹理骨科植入物的设计和潜在的标准化监管测试具有广泛的意义。
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引用次数: 3
In vivo, in situ and ex vivo comparison of porcine skin for microprojection array penetration depth, delivery efficiency and elastic modulus assessment. 猪皮肤的体内、原位和离体比较,用于微注射阵列穿透深度、递送效率和弹性模量评估。
Pub Date : 2022-03-01 DOI: 10.2139/ssrn.3998970
Jonathan C. J. Wei, Ian D. Cartmill, M. Kendall, M. Crichton
With the development of wearable technologies, the interfacial properties of skin and devices have become much more important. For research and development purposes, porcine skin is often used to evaluate device performance, but the differences between in vivo, in situ and ex vivo porcine skin mechanical properties can potentially misdirect investigators during the development of their technology. In this study, we investigated the significant changes to mechanical properties with and without perfusion (in vivo versus in vitro tissue). The device focus for this study was a skin-targeting Nanopatch vaccine microneedle device, employed to assess the variance to key skin engagement parameters - penetration depth and delivery efficiency - due to different tissue conditions. The patches were coated with fluorescent or 14C radiolabelled formulations for penetration depth and delivery efficiency quantification in vivo, and at time points up to 4 h post mortem. An immediate cessation of blood circulation saw mean microneedle penetration depth fell from ∼100 μm to ∼55 μm (∼45%). Stiffening of underlying tissues as a result of rigor mortis then augmented the penetration depths at the 4 h timepoint back to ∼100 μm, insignificantly different (p = 0.0595) when compared with in vivo. The highest delivery efficiency of formulation into the skin (dose measured in the skin excluding leftover dose on skin and patch surfaces) was also observed at this time point of ∼25%, up from ∼2% in vivo. Data obtained herein progresses medical device development, highlighting the need to consider the state and muscle tissues when evaluating prototypes on cadavers.
随着可穿戴技术的发展,皮肤和设备的界面特性变得更加重要。出于研发目的,猪皮通常用于评估设备性能,但体内、原位和离体猪皮机械性能之间的差异可能会在技术开发过程中误导研究人员。在这项研究中,我们研究了有灌注和无灌注时(体内组织与体外组织)机械性能的显著变化。本研究的设备重点是皮肤靶向纳米疫苗微针设备,用于评估由于不同组织条件导致的关键皮肤接触参数(穿透深度和递送效率)的变化。用荧光或14C放射性标记的制剂包被贴片,用于体内和死后4小时的时间点的穿透深度和递送效率定量。血液循环立即停止后,微针的平均穿透深度从~100μm下降到~55μm(~45%)。由于尸僵导致的下层组织硬化,然后在4小时的时间点将穿透深度增加到~100μm,与体内相比差异不大(p=0.0595)。在这个时间点,也观察到制剂进入皮肤的最高递送效率(在皮肤中测量的剂量,不包括皮肤和贴片表面的剩余剂量)为~25%,高于体内的~2%。本文获得的数据促进了医疗设备的开发,强调了在评估尸体原型时需要考虑状态和肌肉组织。
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引用次数: 2
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Journal of the mechanical behavior of biomedical materials
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