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Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices

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A special issue of Materials (ISSN 1996-1944). This special issue belongs to the section "Biomaterials".

Deadline for manuscript submissions: closed (30 November 2021) | Viewed by 15235

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Special Issue Editors

Prof. Cristina Bignardi

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Guest Editor

Polito^BIOMed Lab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Corso Duca degli Abruzzi 24, 10129 Torino, Italy
Interests: numerical and experimental structural analysis; bone biomechanics; human joints and arthroprostheses; dental biomechanics; characterization of biological tissue at different scales of investigation

Dr. Mara Terzini

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Guest Editor

Polito^BIOMed Lab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Corso Duca degli Abruzzi 24, 10129 Torino, Italy
Interests: soft tissues and biomaterials mechanical characterization; implantable devices FEM analysis; human joint multibody analysis; design of experiments

Special Issue Information

Dear Colleagues,

In the mechanical characterization of materials or devices, the real load conditions to which materials and devices are subjected must often be simulated, starting from the availability of universal testing machines. Although sophisticated, these machines only apply uniaxial loads or, at most, simultaneously apply loads along orthogonal axes.

This consideration is all the more true in the field of biomedical engineering, where the physiological loads and environments to which biological tissues and biomaterials are subjected are complex and where there is the need to characterize biomechanical systems consisting of prostheses, devices, and devices coupled to the receiving organs or physiological tissues.

The purpose of this Issue is to gather studies in different areas of biomedical engineering; orthopedic, dental, and cardiovascular biomechanics, etc.; mechanical characterization methodologies on different scales of biological materials and tissues; implantable and non-implantable materials; biomaterials; and simple or complex devices. Some loading solutions designed in the absence of indications from existing regulations to simulate the real physiological loading conditions, as much as possible, to which biological tissues, biomaterials, medical devices (prostheses, osteosynthesis systems, sutures, etc.), and biomechanical systems are subjected are of particular interest for this Issue.

Studies investigating the structural behavior of materials or structures, verifying the availability of adequate testing machines before inventing new loading systems, investigating the existence of possible regulatory indications and, in their absence, looked to the literature for similar research from which to start are also welcome.

Prof. Cristina Bignardi
Dr. Mara Terzini
Guest Editors

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Keywords

in vitro biomaterials testing;
physiological environment replication;
testing set up design;
testing methodology design;
biomechanics of biological materials;
biomechanics of biomedical devices;
material behavior;
mechanics of materials;
material interaction with human tissues;
experimentation;
materials applications in medicine

Published Papers (7 papers)

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Research

15 pages, 28243 KiB

Open AccessArticle

Mechanical and Morphological Assessment of an Innovative Textile for Patient Positioning Applications: Comparison to Two Standard Bandage Systems

by David Putzer, Dietmar Dammerer, Débora Coraça-Huber, Johannes Pallua, Werner Schmölz and Michael Nogler

Materials 2021, 14(6), 1508; https://0-doi-org.brum.beds.ac.uk/10.3390/ma14061508 - 19 Mar 2021

Cited by 2 | Viewed by 1574

Abstract

In the healthcare environment, bandage systems are versatile medical devices to position and fix patients’ torsos or extremities. In this study, the mechanical and morphological properties of an innovative patient position system, iFix, were assessed and compared to two commercially available bandages. Morphological properties were investigated using a scanning electron microscope (SEM). The iFix bandage showed anisotropic mechanical properties, with a more rigid behavior in the longitudinal direction and a more elastic behavior in the transverse direction. This behavior results from the organization of the fibers visible in the SEM images. All three materials investigated in this study were able to support similar maximum loads. In cases where a rigid fixation of patient limbs or torso is necessary, the authors recommend the usage of iFix. In vivo studies should be carried out to prove safety in a surgical environment before its clinical usage. Full article

(This article belongs to the Special Issue Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices)

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13 pages, 4449 KiB

Open AccessArticle

The Development of Equipment to Measure Mesh Erosion of Soft Tissue

by Amanda Schmidt, Gordon O’Brien and David Taylor

Materials 2021, 14(4), 941; https://0-doi-org.brum.beds.ac.uk/10.3390/ma14040941 - 17 Feb 2021

Cited by 3 | Viewed by 2009

Abstract

Mesh erosion is a phenomenon whereby soft tissue becomes damaged as a result of contact with implants made from surgical mesh, a fabric-like material consisting of fibers of polypropylene or other polymers. This paper describes the design and construction of a testing machine to generate mesh erosion in vitro. A sample of mesh in the form of a 10 mm wide tape is pressed against soft tissue (porcine muscle) with a given force, and a given reciprocating movement is applied between the mesh and the tissue. To demonstrate the capabilities of the equipment, we measured erosion using the same mesh and tissue type, varying the applied force and the reciprocating stroke length, including zero strokes (i.e., static loading). For comparison, we also tested four other samples of polypropylene with different edge characteristics. Analysis of the results suggests the existence of three different erosion mechanisms: cutting, wear and creep. It is concluded that the equipment provides a useful and realistic simulation of mesh erosion, a phenomenon that is of great clinical significance and merits further study. Full article

(This article belongs to the Special Issue Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices)

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15 pages, 2803 KiB

Open AccessArticle

Biomechanical Design and Prototyping of a Powered Ankle-Foot Prosthesis

by Stefano Alleva, Michele Gabrio Antonelli, Pierluigi Beomonte Zobel and Francesco Durante

Materials 2020, 13(24), 5806; https://0-doi-org.brum.beds.ac.uk/10.3390/ma13245806 - 19 Dec 2020

Cited by 9 | Viewed by 2748

Abstract

Powered ankle-foot prostheses for walking often have limitations in the range of motion and in push-off power, if compared to a lower limb of a healthy person. A new design of a powered ankle-foot prosthesis is proposed to obtain a wide range of motion and an adequate power for a push-off step. The design methodology for this prosthesis has three points. In the first one, a dimensionless kinematic model of the lower limb in the sagittal plane is built, through an experimental campaign with healthy subjects, to calculate the angles of lower limb during the gait. In the second point a multibody inverse dynamic model of the lower limb is constructed to calculate the foot-ground contact force, its point of application and the ankle torque too, entering as input data the calculated angles of the lower limb in the previous point. The third point requires, as input of the inverse dynamic model, the first dimensioning data of the ankle-foot prosthesis to obtain the load acting on the components of the prosthesis and the angle torque of the actuator during the gait cycle. Finally, an iteration cycle begins with the inverse dynamic model modifying the ankle torque and angle until these quantities during the gait are as close as possible to the physiological quantities. After the mechanical design and the construction of the prototype of the prosthesis, an experimental methodology was used for preliminary validation of the design. The preliminary tests in the laboratory on the prototype alone show that the range of motion of the ankle angle during the gait is close to a healthy person’s: 27.6° vs. 29°. The pushing force of the distal area of the prototype is 1.000 N, instead of 1.600 N, because a budget reduction forced us to choose components for the prototype with lower performance. Full article

(This article belongs to the Special Issue Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices)

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18 pages, 3284 KiB

Open AccessArticle

Comparison of Test Setups for the Experimental Evaluation of the Primary Fixation Stability of Acetabular Cups

by Christian Schulze, Danny Vogel, Sina Mallow and Rainer Bader

Materials 2020, 13(18), 3982; https://0-doi-org.brum.beds.ac.uk/10.3390/ma13183982 - 09 Sep 2020

Cited by 3 | Viewed by 2163

Abstract

Sufficient primary fixation stability is the basis for the osseointegration of cementless acetabular cups. Several test methods have been established for determining the tilting moment of acetabular press-fit cups, which is a measure for their primary fixation stability. The central aim of this experimental study was to show the differences between the commonly used lever-out test method (Method 1) and the edge-load test method (Method 2) in which the cup insert is axially loaded (1 kN) during the tilting process with respect to the parameters, tilting moment, and interface stiffness. Therefore, using a biomechanical cup block model, a press-fit cup design with a macro-structured surface was pushed into three cavity types (intact, moderate superior defect, and two-point-pinching cavity) made of 15 pcf and 30 pcf polyurethane foam blocks (n = 3 per cavity and foam density combination), respectively. Subsequently, the acetabular cup was disassembled from the three artificial bone cavities using the lever-out and the edge-load test method. Tilting moments determined with Method 1 ranged from 2.72 ± 0.29 Nm to 49.08 ± 1.50 Nm, and with Method 2, they ranged from 41.40 ± 1.05 Nm to 112.86 ± 5.29 Nm. In Method 2, larger areas of abrasion were observed in the artificial bone cavity compared to Method 1. This indicates increased shear forces at the implant–bone interface in the former method. In conclusion, Method 1 simulates the technique used by orthopedic surgeons to assess the correct fit of the trial cup, while Method 2 simulates the tilting of the cup in the acetabular bone cavity under in situ loading with the hip resultant force. Full article

(This article belongs to the Special Issue Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices)

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13 pages, 8220 KiB

Open AccessArticle

Dynamic Characterization of the Biomechanical Behaviour of Bovine Ovarian Cortical Tissue and Its Short-Term Effect on Ovarian Tissue and Follicles

by Giulia Pascoletti, Maddalena Di Nardo, Gionata Fragomeni, Vincenza Barbato, Teresa Capriglione, Roberto Gualtieri, Riccardo Talevi, Gerardo Catapano and Elisabetta M. Zanetti

Materials 2020, 13(17), 3759; https://0-doi-org.brum.beds.ac.uk/10.3390/ma13173759 - 25 Aug 2020

Cited by 8 | Viewed by 2142

Abstract

The ovary is a dynamic mechanoresponsive organ. In vitro, tissue biomechanics was reported to affect follicle activation mainly through the Hippo pathway. Only recently, ovary responsiveness to mechanical signals was exploited for reproductive purposes. Unfortunately, poor characterization of ovarian cortex biomechanics and of the mechanical challenge hampers reproducible and effective treatments, and prevention of tissue damages. In this study the biomechanical response of ovarian cortical tissue from abattoir bovines was characterized for the first time. Ovarian cortical tissue fragments were subjected to uniaxial dynamic testing at frequencies up to 30 Hz, and at increasing average stresses. Tissue structure prior to and after testing was characterized by histology, with established fixation and staining protocols, to assess follicle quality and stage. Tissue properties largely varied with the donor. Bovine ovarian cortical tissue consistently exhibited a nonlinear viscoelastic behavior, with dominant elastic characteristics, in the low range of other reproductive tissues, and significant creep. Strain rate was independent of the applied stress. Histological analysis prior to and after mechanical tests showed that the short-term dynamic mechanical test used for the study did not cause significant tissue tear, nor follicle expulsion or cell damage. Full article

(This article belongs to the Special Issue Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices)

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11 pages, 3436 KiB

Open AccessArticle

In Vitro Simulation of Dental Implant Bridges Removal: Influence of Luting Agent and Abutments Geometry on Retrievability

by Andrea T. Lugas, Mara Terzini, Elisabetta M. Zanetti, Gianmario Schierano, Carlo Manzella, Domenico Baldi, Cristina Bignardi and Alberto L. Audenino

Materials 2020, 13(12), 2797; https://0-doi-org.brum.beds.ac.uk/10.3390/ma13122797 - 21 Jun 2020

Cited by 8 | Viewed by 1837

Abstract

Implant fixed dental prostheses are widely used for the treatment of edentulism, often preferred over the screw-retained ones. However, one of the main features of an implant-supported prosthesis is retrievability, which could be necessary in the case of implant complications. In this study, the retrievability of implant-fixed dental prostheses was investigated considering two of the main factors dental practitioners have to deal with: the abutments geometry and the luting agent. Impulsive forces were applied to dental bridge models to simulate crowns’ retrievability in clinical conditions. The number of impulses and the impulsive force delivered during each test were recorded and used as retrievability indexes. One-hundred-and-five tests were conducted on 21 combinations of bridges and luting agents, and a Kruskal-Wallis test was performed on the results. The abutment geometry significantly influenced the number of impulses needed for retrieval (p < 0.05), and a cement-dependent trend was observed as well. On the other hand, the forces measured during tests showed no clear correlation with bridge retrievability. The best retrievability was obtained with long, slightly tapered abutments and a temporary luting agent. Full article

(This article belongs to the Special Issue Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices)

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11 pages, 4054 KiB

Open AccessArticle

In Vitro Impact Testing to Simulate Implant-Supported Prosthesis Retrievability in Clinical Practice: Influence of Cement and Abutment Geometry

by Andrea T. Lugas, Mara Terzini, Elisabetta M. Zanetti, Gianmario Schierano, Carlo Manzella, Domenico Baldi, Cristina Bignardi and Alberto L. Audenino

Materials 2020, 13(7), 1749; https://0-doi-org.brum.beds.ac.uk/10.3390/ma13071749 - 09 Apr 2020

Cited by 9 | Viewed by 2102

Abstract

Cement-retained implant-supported prosthetics are gaining popularity compared to the alternative screw-retained type, a rise that serves to highlight the importance of retrievability. The aim of the present investigation is to determine the influence of luting agent, abutment height and taper angle on the retrievability of abutment–coping cementations. Abutments with different heights and tapers were screwed onto an implant and their cobalt-chrome copings were cemented on the abutments using three different luting agents. The removals were performed by means of Coronaflex^®. The number of impulses and the forces were recorded and analyzed with a Kruskal–Wallis test. Harvard cement needed the highest number of impulses for retrieval, followed by Telio CS and Temp Bond. However, abutment height and taper showed a greater influence on the cap’s retrievability (p < 0.05). Long and tapered abutments provided the highest percentage of good retrievability. The influence of the luting agent and the abutment geometry on the cap’s retrieval performed by Coronaflex^® reflects data from literature about the influence of the same factor on the maximum force reached during uniaxial tensile tests. The impulse force was slightly affected by the same factors. Full article

(This article belongs to the Special Issue Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices)

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