Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

The complexity of modern surgical and analytical methods requires the miniaturisation of many medical devices. The LIGA technique and also mechanical microengineering are well known for the batch fabrication of microsystems. Actuators and sensors are developed based on these techniques. The hydraulic actuation principle is advantageous for medical applications since the energy may be supplied by pressurised balanced salt solution. Some examples are turbines, pumps and valves. In addition, optical sensors and components are useful for analysis and inspection as represented by microspectrometers and spherical lenses. Finally, plastic containers with microporous bottoms allow a 3-dimensional growth of cell culture systems.

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Biological Evaluation of Medical Devices in the Form of Suppositories for Rectal and Vaginal Use

Innovative Biosystems and Bioengineering ◽

10.20535/ibb.2021.5.4.249082 ◽

2021 ◽

Vol 5 (4) ◽

pp. 228-237

Author(s):

Oleksandra Dmytrenko ◽

Maryna Arkhypova ◽

Darya Starosyla ◽

Svitlana Rybalko ◽

Michael Gevorkyan ◽

...

Keyword(s):

Cell Culture ◽

Vero Cell ◽

Medical Device ◽

Medical Devices ◽

Biological Evaluation ◽

Vero Cell Culture ◽

Regulatory Status ◽

Octenidine Dihydrochloride

Background. Programs of preclinical safety studies of the health care products depend on the regulatory status of the investigated products. The classification of such products, in particular suppositories for rectal and vaginal use, is a critical step of developing tactics for their biological evaluation. Adaptation of biological evaluation methods for the medical devices based on the combination of biologically active substances, as well as evaluation of the results of such studies is urgent task of biomedicine. Objective. To substantiate the regulatory status and to carry out a biological evaluation of medical devices in the form of vaginal suppositories based on octenidine dihydrochloride ("Prodexyn") and in the form of rectal suppositories based on Saw palmetto, Levisticum officinale and Calendula officinalis extracts ("Pravenor"). Methods. Biological evaluation was conducted according to the requirements of ISO 10993 standards using in vitro and in vivo biological test systems (cytotoxicity in cell culture and the MTT test, sensitizing and irritating effect in guinea pigs). Results. The cytotoxicity (СС50) of the medical device "Prodexyn" extract in Vero cell culture was 8.35 μg/ml calculated as octenidine dihydrochloride and 416.65 μg/ml calculated as dexpanthenol. "Pravenor" medical device was found to be non-toxic in Vero cell culture. According to the results of MMT assay CC50 for octenidine dihydrochloride was 1.67 μg/ml, and 83.33 μg/ml – for dexpanthenol. CC50 indicators calculated for the different active ingredients of the medical device "Pravenor" were the following: 50 mg/ml for the dwarf palm berries extract (Saw palmetto), 16.67 mg/ml for the lovage roots extract (Levisticum officinale), and 16.67 mg/ml for the calendula flowers extract (Calendula officinalis). No sensitizing or skin irritating effects were observed in guinea pigs. Conclusions. Biological evaluation of medical devices in the form of rectal suppositories "Pravenor" and vaginal suppositories "Prodexyn" performed using in vitro and in vivo biological systems. It was demonstrated an acceptable level of safety of the products. The MTT test was 5 times more sensitive than the Vero cell culture method in determination of cytotoxicity.

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Novel Quantitative Methods for the Determination of Biomaterial Cytotoxicity

The International Journal of Artificial Organs ◽

10.1177/039139889201500310 ◽

1992 ◽

Vol 15 (3) ◽

pp. 191-194 ◽

Cited By ~ 27

Author(s):

M.D. Smith ◽

J.C. Barbenel ◽

J.M. Courtney ◽

M.H. Grant

Keyword(s):

Cell Culture ◽

Medical Devices ◽

Mtt Assay ◽

Quantitative Methods ◽

Artificial Organs ◽

Fluorimetric Assay ◽

Standardized Protocol ◽

Ht1080 Cells ◽

Quantitative Results

Two novel methods for the determination of biomaterial cytotoxicity using cell culture are presented. The methods combine a standardized protocol for producing extracts from medical devices with either the established MTT assay or a new fluorimetric assay. The suitability of both methods for evaluating the toxicity of candidate materials was demonstrated by resolution of the differences in the toxic effects of serial dilutions of a PVC extract on BHK21 and HT1080 cells. The tests yield highly reproducible, quantitative results and can be applied to materials in the usual physical forms applicable to artificial organs.

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A methodology to develop a vascular geometry for in vitro cell culture using additive manufacturing

International Journal of Bioprinting ◽

10.18063/ijb.v5i2.238 ◽

2019 ◽

Vol 5 (2) ◽

Author(s):

Laurene Lenoir ◽

Frederick Segonds ◽

Peyre kim-anh Nguyen ◽

Pablo Bartolucci

Keyword(s):

Cell Culture ◽

Additive Manufacturing ◽

Medical Devices ◽

State Of The Art ◽

Medical Industry ◽

In Vitro Studies ◽

Biological Research ◽

Development Method ◽

Vascular Geometry

Today, additive manufacturing (AM) is implemented in medical industry and profoundly revolutionizes this area. This approach consists of producing parts by additions of layers of successive materials and offers advantages in terms of rapidity, complexity of parts, competitive costs that can be exploited and can lead to a significant advancement in biological research. Everything becomes technically feasible and gives way to a “techno-centered” approach. Many parameters must be controlled in this field, so it is necessary to be guided for the development of such a product. This article aims to present a state of the art of existing design methodologies focused on AM to create medical devices. Finally, a development method is proposed that consists of producing vascular geometry using AM, based on patient data, designed for cell culture in vitro studies.

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