Perspectives on In Vivo Testing of Biomaterials, Prostheses, and Artificial Organs

1988 ◽  
Vol 7 (4) ◽  
pp. 469-479 ◽  
Author(s):  
James M. Anderson
Keyword(s):  
Foreign Body ◽  
Medical Device ◽  
Medical Devices ◽  
Host Response ◽  
Foreign Body Reaction ◽  
Artificial Organs ◽  
In Vivo Testing ◽  
Biological Environment

The goal of in vivo testing of a medical device is to determine the safety or biocompatibility of the device in a biological environment. Biocompatibility is the ability of a medical device to perform with an appropriate host response in a specific application. Biocompatibility assessment is considered to be a measure of the magnitude and duration of adverse alterations in homeostatic mechanisms that determine the host response. Perspectives are provided on the role of injury, tissue responses to medical devices, and blood responses to medical devices. The concept of the normal foreign body reaction is presented. The potential importance of the macrophage, an important component of the foreign body reaction, in controlling the biocompatibility in the in vivo environment is discussed.

scholarly journals All-polymeric transient neural probe for prolonged in-vivo electrophysiological recordings

2021 ◽  
Author(s):  
Laura Ferlauto ◽  
Paola Vagni ◽  
Elodie Geneviève Zollinger ◽  
Adele Fanelli ◽  
Katia Monsorno ◽  
...  
Keyword(s):  
Foreign Body ◽  
Medical Devices ◽  
Foreign Body Reaction ◽  
Brain Activity ◽  
Degradation Process ◽  
Proof Of Concept ◽  
Neural Probes ◽  
Electrophysiological Recordings ◽  
Transient Metals

AbstractTransient bioelectronics has grown fast, opening possibilities never thought before. In medicine, transient implantable devices are interesting because they could eliminate the risks related to surgical retrieval and reduce the chronic foreign body reaction. However, despite recent progress in this area, the short functional lifetime of devices due to short-lived transient metals, which is typically a few days or weeks, still limits the potential of transient medical devices. We report that a switch from transient metals to an entirely polymer-based approach allows for a slower degradation process and a longer lifetime of the transient probe, thus opening new possibilities for transient medical devices. As a proof-of-concept, we fabricated all-polymeric transient neural probes that can monitor brain activity in mice for a few months rather than a few days or weeks. Also, we extensively evaluated the foreign body reaction around the implant during the probe’s degradation. This kind of devices might pave the way for several applications in neuroprosthetics.

scholarly journals Large Animal Studies to Reduce the Foreign Body Reaction in Brain–Computer Interfaces: A Systematic Review

Biosensors ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 275
Author(s):  
Shan Yasin Mian ◽  
Jonathan Roy Honey ◽  
Alejandro Carnicer-Lombarte ◽  
Damiano Giuseppe Barone
Keyword(s):  
Foreign Body ◽  
Animal Studies ◽  
Foreign Body Reaction ◽  
Inflammatory Cells ◽  
Anatomical Location ◽  
Large Animal ◽  
Brain Computer Interfaces ◽  
Computer Interfaces ◽  
Electrode Insertion

Brain–computer interfaces (BCI) are reliant on the interface between electrodes and neurons to function. The foreign body reaction (FBR) that occurs in response to electrodes in the brain alters this interface and may pollute detected signals, ultimately impeding BCI function. The size of the FBR is influenced by several key factors explored in this review; namely, (a) the size of the animal tested, (b) anatomical location of the BCI, (c) the electrode morphology and coating, (d) the mechanics of electrode insertion, and (e) pharmacological modification (e.g., drug eluting electrodes). Trialing methods to reduce FBR in vivo, particularly in large models, is important to enable further translation in humans, and we systematically reviewed the literature to this effect. The OVID, MEDLINE, EMBASE, SCOPUS and Scholar databases were searched. Compiled results were analysed qualitatively. Out of 8388 yielded articles, 13 were included for analysis, with most excluded studies experimenting on murine models. Cats, rabbits, and a variety of breeds of minipig/marmoset were trialed. On average, over 30% reduction in inflammatory cells of FBR on post mortem histology was noted across intervention groups. Similar strategies to those used in rodent models, including tip modification and flexible and sinusoidal electrode configurations, all produced good effects in histology; however, a notable absence of trials examining the effect on BCI end-function was noted. Future studies should assess whether the reduction in FBR correlates to an improvement in the functional effect of the intended BCI.

The Influence of Bioactive Glass Particles on Osteolysis

2007 ◽  
Vol 330-332 ◽  
pp. 193-196
Author(s):  
Duck Hyun Kim ◽  
Kang Sik Lee ◽  
Jung Hwa Kim ◽  
Jae Suk Chang ◽  
Yung Tae Kim
Keyword(s):  
Foreign Body ◽  
Bioactive Glass ◽  
Foreign Body Reaction ◽  
Statistical Significance ◽  
Giant Cells ◽  
In Vivo Test ◽  
Micro Particles ◽  
Rat Calvaria ◽  
Replacement Arthroplasty

We observed the cytotoxicity of human bone marrow stromal cells(hBMSCs) by microparticles of bioactive glass with four particle groups(same chemical composition-45S5 but produced by two different manufacturer and two different size groups). In vivo test using rat calvaria were also carried out. The apoptosis rates of all small particle groups(10-20 ㎛) were increased than large(500-700 ㎛ or 200-900 ㎛) particle groups in any culture time and any amount of particles with statistical significance. In vivo study we observed pathologic signs such as macrophages and foreign-body giant cells in rat calvaria by micro-particles of bioglass. Small(10- 20 ㎛) sized particles induced foreign body reaction and bone resorption. There was proliferation of macrophages and cells in large number. But in large particle groups, only fibroblasts were surrounding the particles. The micro-particles of bioglass induced apoptosis of hBMSC and foreign body reaction in calvaria of rat, therefore micro-particles of bioglass may cause osteolysis if used in replacement arthroplasty.

scholarly journals In vivo testing of the role of Alzheimer’s disease coding variants

2020 ◽  
Vol 16 (S3) ◽  
Author(s):  
Michael Sasner ◽  
Adrian L. Oblak ◽  
Dylan Garceau ◽  
Kevin P. Kotredes ◽  
Christoph Preuss ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
In Vivo Testing ◽  
Coding Variants

Systemic anti-IFN-? treatment and role of macrophage subsets in the foreign body reaction to dermal sheep collagen in rats

2000 ◽  
Vol 49 (3) ◽  
pp. 297-304 ◽  
Author(s):  
I. M. S. L. Khouw ◽  
P. B. van Wachem ◽  
R. J. van der Worp ◽  
T. K. van den Berg ◽  
L. F. M. H. de Leij ◽  
...  
Keyword(s):  
Foreign Body ◽  
Foreign Body Reaction ◽  
Ifn Treatment ◽  
Macrophage Subsets

scholarly journals Mechanical matching of implant to host minimises foreign body reaction

2019 ◽  
Author(s):  
Alejandro Carnicer-Lombarte ◽  
Damiano G. Barone ◽  
Ivan B. Dimov ◽  
Russell S. Hamilton ◽  
Malwina Prater ◽  
...  
Keyword(s):  
Foreign Body ◽  
Foreign Body Reaction ◽  
Scar Tissue ◽  
Host Tissue ◽  
Medical Implants ◽  
Implant Surface ◽  
Biomedical Implant ◽  
Manufacturing Techniques ◽  
Implant Coatings

AbstractMedical implants offer a unique and powerful therapeutic approach in many areas of medicine. However, their lifetime is often limited as they may cause a foreign body reaction (FBR) leading to their encapsulation by scar tissue1–4. Despite the importance of this process, how cells recognise implanted materials is still poorly understood5, 6. Here, we show how the mechanical mismatch between implants and host tissue leads to FBR. Fibroblasts and macrophages, which are both crucially involved in mediating FBR, became activated when cultured on materials just above the stiffness found in healthy tissue. Coating implants with a thin layer of hydrogel or silicone with a tissue-like elastic modulus of ∼1 kPa or below led to significantly reduced levels of inflammation and fibrosis after chronic implantation both in peripheral nerves and subcutaneously. This effect was linked to the nuclear localisation of the mechanosensitive transcriptional regulator YAP in vivo. Hence, we identify the mechanical mismatch between implant and tissue as a driver of FBR. Soft implant coatings matching the mechanical properties of host tissue minimized FBR and may be used as a novel therapeutic strategy to improve long-term biomedical implant stability without extensive modification of current implant manufacturing techniques, thus facilitating clinical translation.One sentence summaryForeign body reaction to medical implants can be avoided by matching the stiffness of the implant surface to that of the host tissue.

scholarly journals Biocompatibility of Medical Devices - A Review

2021 ◽  
Vol 10 (36) ◽  
pp. 3152-3158
Author(s):  
Ramya Shree Gangadhar ◽  
Balamuralidhara V ◽  
Rajeshwari S.R.
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Human Body ◽  
The Body ◽  
Biological Responses ◽  
Medical Device Manufacturers ◽  
Biocompatibility Testing ◽  
Biological Environment ◽  
Key Words Biocompatibility

BACKGROUND Biomaterial is defined as "any substance or combination of medicine, artificial or natural origin, which can be used at any time, in whole or part by a system that controls, adds to, or restores any tissue, organ or function". ISO 10993-1: 2018 standard defines bio compliance law as "the ability of a medical device or tool to perform a selected program with the acceptable response of experts". Incompatible factors cause chemical reactions in patients, with little or no side effects. The body can respond in a sort of way after the installation of medical devices, so testing and improvement is important here. Therefore, testing and improvement in this field are important. Biocompatibility is required for any significant use of components or materials in medical devices. Inconsistent factors create negative biological responses in patients, which may have serious consequences. Biomaterials are substances utilized in medical devices, especially in applications where the device is touched, temporarily embedded, or permanently implanted within the body. Because of the significant impact of biocompatibility, many countries have imposed regulations on medical device manufacturers to meet biocompatibility specifications. Here is a brief explanation about the biocompatibility and incompatibility parameters of medical devices with a human body and its need for biocompatibility of medical devices with the human body. Medical devices have improved doctors' ability to diagnose and treat disease, which has led to significant improvements in health and quality of life. Thus, medical devices are prone to various incompatibility issues and procedures that affect the biological environment must be followed. KEY WORDS Biocompatibility, Material Interactions, Sterilization, Medical devices, Biocompatibility Testing, Incompatibility Factors.

Measuring the progression of foreign-body reaction to silicone implants using in vivo MR microscopy

1998 ◽  
Vol 45 (7) ◽  
pp. 921-927 ◽  
Author(s):  
H.H. Qiu ◽  
L.W. Hedlund ◽  
M.R. Neuman ◽  
C.R. Edwards ◽  
R.D. Black ◽  
...  
Keyword(s):  
Foreign Body ◽  
Foreign Body Reaction ◽  
Silicone Implants ◽  
Mr Microscopy
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