Fatigue and Hemocompatibility of Polymer Materials

Sevastianov, V. I.; Parfeev, V. M.

doi:10.1111/j.1525-1594.1987.tb02621.x

Cited by 10 publications

(4 citation statements)

References 2 publications

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“…Various researchers have investigated the effects of dynamic stresses on PEUs,17–22 but most of the studies did not directly address biostability. Furthermore, most fatigue experiments were performed in uniaxial tension, whereas the diaphragm operates under multiaxial stresses.…”

Section: Introductionmentioning

confidence: 99%

Biodegradation of polyurethane under fatigue loading

Wiggins

Anderson

Hiltner

2003

J Biomedical Materials Res

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A method utilizing expansion of a diaphragm-type film specimen was developed to study in vitro biodegradation of poly(etherurethane urea) (PEUU) under conditions of dynamic loading (fatigue). A finite element model was used to describe the strain state, which ranged from uniaxial at the edges of the film to balanced biaxial tensile strain at the center. During testing, the film was exposed to a H(2)O(2)/CoCl(2) solution, which simulated in vivo oxidative biodegradation of PEUU. The extent of chemical degradation was determined by infrared analysis. Physical damage of the film surface was characterized by optical microscopy and scanning electron microscopy. Dynamic loading did not affect the rate of degradation relative to unstressed and constant stress (creep) controls in regions of the film that experienced primarily uniaxial fatigue; however, degradation was accelerated in regions that experienced balanced biaxial or almost balanced biaxial fatigue. It was concluded that the combination of dynamic loading and biaxial tensile strain accelerated oxidative degradation in this system. Chemical degradation produced a brittle surface layer that was marked by numerous pits and dimples. Physical damage of the surface in the form of cracking occurred only in fatigue experiments. Cracking was not observed in unstressed or creep tests. Cracks initiated at the dimples produced by chemical degradation, and propagated in a direction that was determined by the strain state.

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Section: Introductionmentioning

confidence: 99%

Biodegradation of polyurethane under fatigue loading

Wiggins

Anderson

Hiltner

2003

J Biomedical Materials Res

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“…Blood compatibility is related to materials' chemical properties (functional group distribution) and physical properties (surface charge, surface tension, hydrophilicity/hydrophobicity, wettability) (29,30), hemodynamic conditions, and contact duration. In light of these parameters, several strategies have been employed to improve the blood compatibility of implantable devices.…”

Section: Surface Functionalizationmentioning

confidence: 99%

The Biocompatibility Challenges in the Total Artificial Heart Evolution

Sasso

Bagno

Scuri

et al. 2019

Annu. Rev. Biomed. Eng.

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There are limited therapeutic options for final treatment of end-stage heart failure. Among them, implantation of a total artificial heart (TAH) is an acceptable strategy when suitable donors are not available. TAH development began in the 1930s, followed by a dramatic evolution of the actuation mechanisms operating the mechanical pumps. Nevertheless, the performance of TAHs has not yet been optimized, mainly because of the low biocompatibility of the blood-contacting surfaces. Low hemocompatibility, calcification, and sensitivity to infections seriously affect the success of TAHs. These unsolved issues have led to the withdrawal of many prototypes during preclinical phases of testing. This review offers a comprehensive analysis of the pathophysiological events that may occur in the materials that compose TAHs developed to date. In addition, this review illustrates bioengineering strategies to prevent these events and describes the most significant steps toward the achievement of a fully biocompatible TAH.

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“…Often, blood with clinically inapplicable anticoagulants and under static conditions was incubated with the test device [19–21]. Currently anticoagulation and flow conditions must be as similar as possible to the clinical application to achieve relevant test results.…”

Section: Iso 10993 Requirements For Testing Of Medical Devices: Ismentioning

confidence: 99%

Obstacles in Haemocompatibility Testing

Oeveren¹

2013

Scientifica

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ISO 10993-4 is an international standard describing the methods of testing of medical devices for interactions with blood for regulatory purpose. The complexity of blood responses to biomaterial surfaces and the variability of blood functions in different individuals and species pose difficulties in standardisation. Moreover, in vivo or in vitro testing, as well as the clinical relevance of certain findings, is still matter of debate. This review deals with the major remaining problems, including a brief explanation of surface interactions with blood, the current ISO 10993 requirements for testing, and the role of in vitro test models. The literature is reviewed on anticoagulation, shear rate, blood-air interfaces, incubation time, and the importance of evaluation of the surface area after blood contact. Two test categories deserve further attention: complement and platelet function, including the effects on platelets from adhesion proteins, venipuncture, and animal derived- blood. The material properties, hydrophilicity, and roughness, as well as reference materials, are discussed. Finally this review calls for completing the acceptance criteria in the ISO standard based on a panel of test results.

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Fatigue and Hemocompatibility of Polymer Materials

Cited by 10 publications

References 2 publications

Biodegradation of polyurethane under fatigue loading

Biodegradation of polyurethane under fatigue loading

The Biocompatibility Challenges in the Total Artificial Heart Evolution

Obstacles in Haemocompatibility Testing

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