The immunoreaction caused by biomaterials or medical devices are even more concerned by people. It is necessary to establish the immune items in the biological evaluation of biomaterials and medical devices. And it is a tendency to use immune technique combined with molecular biological methods to evaluate the immunoreaction for biomaterials.
Biocompatible Materials ; adverse effects ; Equipment and Supplies ; adverse effects ; Immunity ; Materials Testing ; methods ; Toxicity Tests

Biomedical materials are the biomaterials that, used in physiological system for diagnosis, treatment, plerosis or replacement of tissues and organs. Apoptosis, also known as PCD or ACD, is a normal physiological mechanism of cell in organism and a process of automatic cell death in which multicell organism modulates the development of organism and maintains the stability of internal environment. The human beings are able to understand the interaction between the material and organism at the molecular level due to the widely-used biomedical material and the development of material science, life science and biological technology. The research of that interaction is mainly focused on biocompatibility, while much attention has been drawn to the apoptosis induced by biomaterial concerning that apoptosis could be caused by inducing factor, and many therapies of diseases are closely related to inducing apoptosis. Based on the recent research advances of apoptosis in life science and the development of biomaterials, the pathways of apoptosis induced by biomaterials were reviewed; from the different views, the pathways of signal transduction of apoptosis include traditional pathway of signal transduction, the pathway of death receptor, and the pathway through mitochondrion. By the other way, the pathways of apoptosis caused by reactive oxygen species induced by biomaterials and apoptosis by affecting cell adhesion to biomaterials and so forth were discussed also. It indicates that the pathways to apoptosis due to biomaterials possess the characteristics of variety, intercrossing and multiplicity. It is essential for a research to inquire into the mechanism of apoptosis that is induced by biomaterials, and further into the manufacturing of biomaterials. This review is devoted to shedding light on the wide application of biomaterials in the therapy of human diseases, especially in the therapy of cancer that is closely related to apoptosis.
Apoptosis ; drug effects ; Biocompatible Materials ; adverse effects ; Cell Adhesion ; drug effects ; Humans ; Materials Testing ; Mitochondria ; physiology ; Signal Transduction

According to ISO 10993 standard series, the biological safety of surface modified pure titanium was studied as a percutaneous device by the test of cytotoxicity in vitro, as well as by the tests of irritation and sensitization. The result from the examination of cytotoxicity in vitro was negative, the skin irritation response was negligible, and the result of test on skin sensitization in guinea pigs was also negligible. So the surface modified pure titanium in this study can be safely used as percutaneous implanting materials.
Animals ; Biocompatible Materials ; chemistry ; Coated Materials, Biocompatible ; chemistry ; Female ; Guinea Pigs ; Implants, Experimental ; adverse effects ; Materials Testing ; Rabbits ; Random Allocation ; Skin Irritancy Tests ; methods ; Surface Properties ; Titanium ; chemistry

Good anticoagulant biomaterials need good surface chemical properties, good mechanics performances and particularly good characteristics of biocompatibility, including tissue compatibility and hemocompatibility. In order to understand with greater clearness the anticoagulant biomaterial, we have to characterize them by different methods. In this paper, the approaches to assessing and displaying the characteristics of anticoagulant biomaterial are reviewed in three aspects, namely the surface chemical properties and structure, the mechanics performances the and the biocompatibility of anticoagulant biomaterial.
Anticoagulants ; Biocompatible Materials ; chemistry ; Blood Coagulation ; drug effects ; Humans ; Materials Testing ; Prostheses and Implants ; adverse effects ; Prosthesis Design ; Surface Properties

This paper has briefly introduced the definition, classification, harms, sources and control of particles, lists the particle evaluation method of coronary stents. And the development trend of particle evaluation method of coronary stents is also analyzed.
Biocompatible Materials ; adverse effects ; Blood Vessel Prosthesis ; Coronary Artery Disease ; therapy ; Humans ; Particle Size ; Stents

As the number of patients suffering from cardiovascular diseases and peripheral vascular diseases rises, the constraints of autologous transplantation remain unavoidable. As a result, artificial vascular grafts must be developed. Adhesion of proteins, platelets and bacteria on implants can result in stenosis, thrombus formation, and postoperative infection, which can be fatal for an implantation. Polyurethane, as a commonly used biomaterial, has been modified in various ways to deal with the adhesions of proteins, platelets, and bacteria and to stimulate endothelium adhesion. In this review, we briefly summarize the mechanisms behind adhesions, overview the current strategies of surface modifications of polyurethane biomaterials used in vascular grafts, and highlight the challenges that need to be addressed in future studies, aiming to gain a more profound understanding of how to develop artificial polyurethane vascular grafts with an enhanced implantation success rate and reduced side effect.
Humans ; Polyurethanes ; Biocompatible Materials ; Blood Vessel Prosthesis/adverse effects* ; Cardiovascular Diseases

Polytetrafluoroethylene (PTFE), polyurethane (PU) and silicone are widely known biocompatible polymers which are commonly used for vascular grafts. However, in vitro and in vivo calcifications of these polymers have been found to seriously compromise their quality as biomaterials. In consideration of this problem, the present study compared the calcification rate and extent of PTFE, PU and silicone. Using the in vitro flow-type method, PTFE, PU and silicone films were tested for 1, 4, 7, 10, 14 and 21 days. After 21 days of in vitro calcification test, the calcium levels on PTFE, PU and silicone were 35.89 5.01 microgram /cm2, 23.73 0.68 microgram/cm2 and 19.86 5.28 microgram/cm2, respectively. The higher observed calcium level for PTFE may be due to the effect of the rough surface of PTFE in accumulating calcium ions on the polymer surface. From the 7th day of test, the [Ca]/[P] molar ratio started to decrease over time, and PTFE showed a faster calcification process. This decreasing [Ca]/[P] molar ratio demonstrated the typical calcification mechanism consisting of phosphorus ion accumulation following calcium ion accumulation. This study concluded that PU and silicone are less calcified than PTFE film, a finding in good agreement with previously published studies.
Biocompatible Materials/*adverse effects ; *Blood Vessel Prosthesis ; Calcinosis/*etiology ; Comparative Study ; Microscopy, Electron, Scanning ; Polytetrafluoroethylene/*adverse effects ; Polyurethanes/*adverse effects ; Silicones/*adverse effects

We conducted studies to confirm the hypothesis that the cellular damage occurring around implanted biphasic bioceramics could be related to a micro-particles release because of an insufficient sintering. An in vitro cytotoxicity study was performed on four biphasic ceramic (BCP) samples. Without the treatment of extraction medium, a cytotoxicity was observed, although after centrifugation this cytotoxicity disappeared in all samples. (2) Micro-particles of HA, beta-TCP and 40%beta-TCP/60%HA mixture were used for a cell inhibition study. A decrease of cell viability was observed with the increase in particles concentration. At 10000 particles/ cell, the viability and proliferation were completely inhibited. (3) HA, beta-TCP and BCP ceramic granules were implanted in rabbit femoral cavities for 12 weeks. No degradation of HA granules was observed. The degradation was higher for beta-TCP (40%) than for BCP (5%). On the other hand, new bone formation was significantly higher for beta-TCP (21%) and HA (18%) than for BCP (12%). Much more micro-particles were formed around BCP granules than around beta-TCP, and were phagocytosed by macrophages. The release of ceramic micro-particles could be related to the sintering process. BCP ceramics have to be sintered at only 1160 degrees C. Consequently, HA microparticles of BCP ceramic are incompletely sintered and easily released after immersion or implantation. The microparticles could be at the origin of local inflammation and cell damage and could perhaps modify osteogenesis. Particular attention must be paid to this problem with regard to BCP ceramics because of the sintering difficulties of this bioceramic.
Biocompatible Materials ; adverse effects ; chemistry ; Calcium Phosphates ; adverse effects ; chemistry ; Cells, Cultured ; Ceramics ; adverse effects ; chemistry ; Fibroblasts ; cytology ; drug effects ; Hydroxyapatites ; adverse effects ; chemistry ; Materials Testing ; Particle Size ; Prostheses and Implants ; adverse effects

There has been increasing attention over the past few years on the potential for the medical devices to cause changes in the immune systems, and it was necessary to provide guidance on how to address the adverse effects of medical devices on the immune system. Here we introduce the principles and methods for immunotoxicology testing of medical devices.
Biocompatible Materials ; Equipment and Supplies ; adverse effects ; standards ; Humans ; Immune System Diseases ; etiology ; Materials Testing ; methods ; standards ; Prostheses and Implants ; adverse effects ; Toxicity Tests ; methods

Postoperative epidural adhesion is one of the most common causes of failed back surgery syndrome (FBSS), which can lead to back and leg pain or neurological deficit. Prevention of epidural adhesion after laminectomy is critical for improving the outcomes of lumbar surgery. The main origins of epidural fibrosis are raw surface of erector muscles and rupture fibers of intervertebral disc. The main current preventive methods for epidural adhesion include the usage of implants, chemicals and low dose radiation. However, most of them are still in experiment period. There are still controversies on the clinic usage of autograft free fat, ADCON-L, and Mitomycin C (MMC). The optimal implants are characteristics of better biocompatibility, degradable absorption and capability of existing for a certain period in body. The optimal medicine should have good effect on anti-desmoplasia, less side effects and long half-life. Besides, the combination of biodegradable medical film and drug and the mixture of two or more medical films are also the research frontlines of epidural adhesion. Further researches are required to explore new materials and drugs with stable and most favorable effect in preventing epidural adhesion.
Biocompatible Materials ; administration & dosage ; Epidural Space ; pathology ; Humans ; Laminectomy ; adverse effects ; Lumbar Vertebrae ; surgery ; Tissue Adhesions ; prevention & control