=Paper= {{Paper |id=Vol-3309/short14 |storemode=property |title=Method for Determining the Electromagnetic Compatibility of Biomaterials |pdfUrl=https://ceur-ws.org/Vol-3309/short14.pdf |volume=Vol-3309 |authors=Oleksiy Yanenko,Kostiantyn Shevchenko,Sergiy Peregudov,Vladyslav Malanchuk,Volodymyr Shvydchenko,Oleksandra Golovchanska |dblpUrl=https://dblp.org/rec/conf/ittap/YanenkoSPMSG22 }} ==Method for Determining the Electromagnetic Compatibility of Biomaterials== https://ceur-ws.org/Vol-3309/short14.pdf
Method for Determining the Electromagnetic Compatibility of
Biomaterials
Oleksiy Yanenkoa, Kostiantyn Shevchenkoa, Sergiy Peregudova, Vladyslav Malanchukb,
Volodymyr Shvydchenkob, and Oleksandra Golovchanskab
a
    Igor Sikorsky Kyiv Polytechnic Institute, 37, Prosp. Peremohy, Kyiv, Ukraine, 03056
b
    National O.Bogomolets Medical University, 34, Prosp. Peremohy, Kyiv, Ukraine


                Abstract
                Biocompatibility of implant materials is one of the decisive factors in the effectiveness of
                reconstructive surgery. The criteria for biocompatibility cover several factors, but they do not
                include electromagnetic compatibility (EMC), which can affect the success of surgical
                operations in the long term. The authors of the article present a method for studying and
                determining the EMC of biomaterials, which contributes to their objective choice. The
                electromagnetic processes that may occur at the interface of contact between the implant and
                biotissue and characterize their interaction are considered. An assessment of the level of
                microwave signals at the temperature of the human body has been carried out, and the
                possibility of generating positive and negative energy fluxes has been shown. The
                electromagnetic properties of a number of implantable biomaterials have been studied and their
                comparative analysis has been carried out. Prognostic recommendations have been developed
                for the experimentally studied materials in order to ensure an increase in the efficiency of
                surgical interventions.

                Keywords 1
                Biomaterials, electromagnetic compatibility, microwave radiation, positive and negative
                fluxes.

1. Introduction
    A wide range of materials of natural and synthetic origin are used in modern medicine, in particular,
bioceramics, bioglass, polymers, metals, as well as composite materials that use organic and inorganic
fillers [1]. Recently, combined biomimetic scaffold (Tour G., 2012) have been used according to the
tissue engineering, the inner base of which are the metal, ceramic or polymeric framework and the outer
coating is dielectric, including the use of nanomaterials and powder fillers to eliminate bone defects
and regenerate soft tissues [2-4].
    The compatibility of biomaterials in contact with human body tissues is determined by many criteria,
in particular resistance to biocorrosion, chemical stability, biological tolerance, biodegradation, etc. It
is usually evaluated in a short period of time when the implant is placed, which can stay and have a
prolonged effect on the human body. Such medical objects, which include implant materials and
implants for prolonged use, are classified by the American FDA as class 111 materials, with a high
probability of risk. Therefore, rather strict conditions of compatibility are imposed for the purpose of
use in the patient's body.
    All manifestations of compatibility or incompatibility, as well as complex biological, chemical and
physical processes take place in the contact area between the biomaterial and the living biotissue.


ITTAP’2022: 2nd International Workshop on Information Technologies: Theoretical and Applied Problems, November 22–24, 2022,
Ternopil, Ukraine
EMAIL: op291@meta.ua (A. 1); k.shevchenko@kpi.ua (A. 2); pereg@i.ua (A. 3); malanchuk_v_a@ukr.net (A. 4); bio4smile@gmail.com
(A. 5); oleksandragolovchanska@gmail.com (A.6)
ORCID: 0000-0001-5450-5619 (A. 1); 0000-0002-7222-9352 (A. 2); 0000-0001-8667-1654 (A. 3); 0000-0001-8111-0436 (A. 4)
             ©️ 2021 Copyright for this paper by its authors.
             Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0).
             CEUR Workshop Proceedings (CEUR-WS.org)
Unfortunately, the study of these processes is complicated by the physical (closed) location of the
implants and requires more detailed research at the microscopic (cellular, molecular) level, in the
implant-biotissue area [5].
    In the process of designing ideal implants for tissue engineering, the graft-tissue contact area is a
very important part that needs to be improved, since most of the interactions between grafts and
surrounding tissues occur exactly in this zone.
    Unresolved and unstudied problems include the presence of a weak electromagnetic field (radiation)
in the contact area of the biomaterial, which is inherent to both living tissue and biomaterial (implant),
which interact due to the introduction of the implant into the human body and its heating to the standard
human body temperature of 36,6o C. This statement is true for dielectric materials, as there is no
radiation of metallic materials due to the skin effect at this temperature.
    The authors of many publications, studying the influence of weak electromagnetic fields (EMF) and
radiation (EMR) of the technogenic nature radio range, point to their mainly negative impact on
biological objects, humans and the environment, especially with prolonged exposure [6,7].
    The available authors studies [8] reflect the impact of a weak EMF of a computer during its
prolonged (more than 6 hours) use on dental tissues. Using the method of laboratory analysis, the
authors confirm the change in the chemical state and the harmful effect of computer EMR on cellular
level.
    However, it is known that short-term, dosed exposure to microwave signals can be effectively used
in microwave therapy in many diseases [9].
    It is important to conduct in-depth studies of the effects of weak EMF, in order to better understand
the levels of compatibility of biological objects and the human body, by frequency and energy range.
    However, numerous theoretical and experimental studies have been conducted on the effect of weak
electromagnetic fields and radiation on the surface layers of biotissues, the criterion of electromagnetic
compatibility (EMC) of biomaterials for internal application has not yet been applied.
    At the same time, dielectric and combined materials used as intratissue implants and
have/form/change their own EMF at human body temperature, which interacts with EMF and human
body structures, at least in the area of their introduction. This interaction can be defined as a new
criterion for the interaction of the human body and the implant, which characterizes their
electromagnetic compatibility in general and can be manifested at the local or general level of the
organism. These issues partially considered by the authors [10].
    Radiating (electromagnetic) characteristics of implants can differ significantly from similar
characteristics of living tissues and, in the long-term variant of their use, are able to disrupt the
electromagnetic state (homeostasis) of surrounding cells.
    In work [11] a method of formation and evaluation of EMR in optical range is proposed. In this case,
depending on the temperature of the optical radiation source, positive and negative fluxes of EMR can
be created, implemented by heating or cooling of the optical radiation source. This paper considers
features and physical processes of appearance of positive and negative fluxes of optical range under the
influence of temperature gradients without analyzing the processes of the physiological impact of such
EMR fluxes on living tissues.
    Using a highly sensitive radiometric system, the authors of [12] registered the presence of positive
and negative EMR fluxes in the microwave range and conducted clinic and laboratory studies of their
effect on biological objects and the human body. According to the results of the studies, a method of
treatment based on the formation, evaluation and use of positive and negative fluxes of EMR of the
microwave range for surface irradiation of human skin was proposed.
    In addition, a number of laboratory experiments were carried out, and the reaction of some surface
biological tissues to the EMR was determined. As a result of laboratory studies, it was revealed that
surface irradiation of a cancerous tumor with positive EMR fluxes accelerates its growth, and with
negative ones it slows it down. The general disadvantage of the studies under consideration is the lack
of connection with the human's internal EMR, which is important for the implants installed in the
human's body.
    Thus, the performed analysis shows that EMR have an impact on biological objects and human body,
therefore preliminary research of electromagnetic compatibility of implantable biomaterials for medical
purposes made of them is an urgent task.
2. Description of the method for assessing the electromagnetic compatibility
   of biomaterials
   The authors of the article proposed a new method for assessing the EMC of implantable biomaterials
before their incorporation into the human body, which consists in the following. First, the average
temperature and EMR are determined at several points of the human (patient) body. Then the
biomaterial under study is heated to the set (average) temperature of the human body and its emissivity
is measured, and the level of deviation of the biomaterial EMR R from the human body radiation is
calculated according to the formula:
                                          R  PM / PH                                            (1)
where PM - radiation level of biomaterial; PH - the average level of radiation of the human body.
    The implementation of the algorithm for measuring and converting signals proposed by the authors
makes it possible to make a more objective assessment of the EMC of biomaterials with biological
tissues of the human body.

3. The physical essence of the method for evaluating EMC biomaterials
    Electromagnetic properties of biomaterials are still insufficiently studied, although they can
significantly influence the processes of their interaction with living tissues at human body temperature.
It can be explained by a very low signal level of the microwave range, which is within 10 -13...10-14 W
at the indicated temperature. At the same time the emissivity of the implant and the nearby biotissues
may differ from each other, that will cause the appearance of difference EMR fluxes.
    At a standard temperature, a heated implant and nearby cells form a noise signal, the integral level
of which can be determined using the Nyquist formula:
                                   P  S  f , T  f  kT f                                      (2)
where S  f , T  - spectral density of the noise EMR of the object under study; k - Boltzmann's constant
(1,3810-23 J/K); T - thermodynamic temperature of the object (К); f - frequency band in which the
measurement is made. For a real radiometric system, the average value is f  1,35  108 Hz. At a
human body temperature of 36,60 C, the integral power calculated by the formula (2) in the analysis
frequency band is PH  5,77 1013 W.
   When the emissivity of the human body PH and biomaterial PM differ, electromagnetic
incompatibility arises, and positive or negative EMR fluxes are formed. The energy of the biotissue
adjacent to the implant may increase or decrease, which is equivalent to the effect of increasing or
decreasing its temperature gradient.
   From the above, the constant effect of the difference in EMR fluxes in the contact area of the
implantable material can positively or negatively affect the processes of reparative tissue regeneration
and decrease or increase the risks of postoperative complications.
   Implementation of the method of formation and evaluation of EMR of biomaterials is carried out at
three stages. At the first stage in several points the exact measurement of human body temperature is
made, and high-sensitivity radiometer measures the level of EMR and determines the average value of
parameters TH , PH . At the second stage, the biomaterial or implant is heated to a certain temperature
TH and the radiation of the biomaterial PM is measured. At the third stage, the level of electromagnetic
compatibility of the biomaterial with the human body is calculated using the formula (1).

4. Results of experimental studies
4.1. Description of technical support
   Fig.1a shows a schematic diagram of the installation for measurements. Measurements were made
on a certified high-sensitivity radiometric system in the laboratory of National Technical University of
Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”. The sensitivity of the system is 1·10-14 W, the
operating range is 37…53 GHz. The study was conducted at a frequency of 52 GHz.




                           a                                                         b
Figure 1: Structural setup for measuring the microwave emissivity of materials (а) Structural setup for
measuring the microwave emissivity of materials (b).
   The diagram shows: 1 - thermostat; 2 - power supply; 3 - temperature controller; 4 - temperature-
controlled plate for heating; 5 - test material; 6 - receiving antenna; 7 - input attenuator; 8 - radiometric
measuring system; 9 – indicator.

4.2.       Description of research materials
   The following biomaterials, which are used in maxillofacial reconstructive surgery were provided
by Oral and Maxillofacial Surgery Department O.Bogomolets National Medical University:
   1. Osteoplast-T is a biomaterial of demineralized and non-demineralized bone collagen in
combination with sulfated glycosaminoglycans.
   2. Polyhemostat – the drug belongs to the pharmacological group of local hemostatic agents. Active
ingredients are: aminocaproic acid, dry extract of Hypericum herb, liquid extract of Yarrow herb, dry
extract of Horsetail herb, dense extract of Nettle leaves, dry extract of Oak bark, 0.05% Chlorhexidine
solution; auxiliary substance – Calcium alginate.
   3. Powder of calcium salt of orthophosphoric acid is a natural mineral compound that is found in
minerals: phosphorite, apatite, hydroxyapatite.
   4. Synthekost – bioactive glass (300-500 microns), used to fill bone defects, as well as for the
induction of subsequent osteogenesis.
   5, 6. Bone defect fillers – preparations Biomin GT 500, Biomin GT 700 - two-phase ceramics based
on hydroxyapatite and tricalcium phosphate with particles of different sizes.
   Samples of biological materials 1, 2 are made from natural living components, and those marked
with positions 3-6 are of mineral synthetic origin. Results of experimental researches of EMR of given
biomaterials and estimation of their relative radiating ability of human body are given in table 1.

Table 1
Results of experimental studies of EMF of biomaterials and assessment of their relative radiation
capacity of the human body
                        Test samples               Power, 1013 W/cm2             PM / PH
       H                      Human                               5.76                          1
       1                    Osteoplast Т                          5.35                        0.92
       2                   Polyhemostat                           5.20                        0.90
       3             Са2 (РО4) – calcium salt                     0.80                        0.14
       4          Bioactive glass (300-500 mkm)                   0.76                        0.13
       5                  Biomin GT -700                          0.04                       < 0.01
       6                  Biomin GT -500                          0.02                       < 0.01
   As noted in Table. 1, the materials most similar in terms of emissivity are Osteoplast-T and
Polygemostat, which have deviations in the EMR level of 7,1 and 9,7%, respectively.
   Using formula (2) and the results of experimental measurements, the authors calculated the
equivalent temperature for the most matching materials T  P / k f , for Osteoplast-T it is 287 K, and
for polyhemostat it is 279,5 K
   The above samples of biomaterials 1 and 2 from table 1 have an emissivity that matches the human
body; materials 3 and 4 are 6-8 times less, and materials 5, 6 are two orders of magnitude less.
   Materials of synthetic origin have a significant deviation from the EMR level of the human body
and correspondingly increased level of negative flux, therefore, preference should be given to materials
with electromagnetic characteristics close to the human body.

5. Conclusions
    1. The use of the suggested method makes it possible to simplify the signal conversion algorithm,
its technical implementation and the possibility of evaluating the EMC of implantable materials with
living tissues, in particular, of the human body.
    2. The conducted research is promising for evaluation of electromagnetic properties and biological
compatibility of implantable biomaterials, in particular those created created using modern
technologies.
    3. The use of microwave electromagnetic radiation-compatible implantable materials with the
human body will not change or disrupt the tissues energy homeostasis of the recipient area and the
course of biological processes in them, including reparative ones.

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