Yachay Tech University

School of Biological Sciences and Engineering

BIOMATERIALS PROJECT #1
BIOCOMPATIBILITY OF MATERIALS
Authors: Luis Acosta, Fanny Laurido, Elizabeth Loza

2022

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 1. ABSTRACT
The population's quality of life and estimated lifespan have increased as a result of
advances in medicine and biomedicine. As a result, the majority of the population is getting
older, which raises the demand for prostheses and implants. As a result of this need,
researchers are looking into new materials that are biocompatible and inert enough to be
accepted by the human body without triggering an immune response. The current work
provides a perspective on the behavior of medical grade stainless steel vs. commercial steel in
order to determine what characteristics make stainless steel suitable for implanting in the
body and how it behaves in various conditions that may occur within the body.

1.1 KEYWORDS:Stainless steel, Biocompatibility, Corrosion, Characterization,

Biomaterials

2. INTRODUCTION.

A biomaterial is any substance, component or material that has been designed to

interact with biological systems for a medical purpose, whether therapeutic or diagnostic. In
order to obtain a biomaterial that can be able to get inside a biological organism, it has to
accomplish some parameters, such as being non-toxic, chemically stable, have adequate
mechanical strength, adequate engineering design, being reproducible and easy to
manufacture, etc., but the most important characteristic that a biomaterial must possess is
being biocompatible.

2.1 Biocompatibility.
The single most important factor that distinguishes a biomaterial from any other
material is its ability to exist in contact with tissues of the human body without causing an
unacceptable degree of harm to that body (Williams, 2018); that is what we know as
biocompatibility, the biological performance of materials. It is extremely important to
consider the biocompatibility of a material if it is intended to use this material inside the
human body. It has been stated that the immune response, the one the host uses to defend
itself against foreign organisms, can be involved in the response to biomaterials (Remes et.
al., 1992). Thus, the main goal of a biomaterial is to not be recognized as a foreign once it
enters the body.

When we talk about the biocompatibility of a material, we should take into account
that there are multiple types of materials and each one of them behaves differently. Among
some examples of biomaterials we can mention polymers, ceramics, composites and metals.
So, to study the biocompatibility of a specific material, which in our case are metallic
materials, it is primordial to identify what characteristic of metallic biomaterials could cause
damage in a biological organism.

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 According to the literature, development and use of metallic biomaterials has focused
on the corrosion resistance of these materials once implanted in the human body (Purnama et.
al., 2010). Therefore, it is mandatory to understand what corrosion is.

2.2 Corrosion of metallic materials.

Corrosion is defined as the destructive attack of a metal by chemical or
electrochemical reaction with water, oxygen and other environments (Revie and Uhlig,
2008). It is mandatory to recognize that corrosion of metallic biomaterials mainly causes the
loss of their structural integrity and surface function. Corrosion not only degrades the metallic
material or alloy, it also accelerates their fatigue, fretting fatigue and wear and, conversely,
such damage accelerates the corrosion (Hiromoto, 2010).

Corrosion is mostly given by electrochemical reactions given on the surface of the

metal, this processes may include generalized corrosion, which uniformly affects the entire
surface of the implant, and localized corrosion, affecting either regions of the device (crevice
corrosion) or seemingly random sites on the surface (pitting corrosion) (Sridhar et. al., 2009).
The process of the electrochemical reactions formed on the surface of the material leads to a
cell formation in which both the anode and the cathode are exchanging electrons and thanks
to the process of reduction and oxidation, the whole surface is attacked. The following figure
illustrates the cell formation process and the reaction between the anode and the cathode.

Figure 1. Local cell formation and cathode and anode interactions.

There are multiple methods that can be used to improve the corrosion resistance of a
material, such as passivation, ion implantation, coating and also, there are multiple alloys of
metals that have helped to improve the medical applications of metallic materials, such as
stainless steel 316L, titanium alloys, chromium-cobalt alloys, etc. However, it is important to
properly select the material to be used considering the fluids or environments to which the
material will be subjected, in order to avoid side effects, such as corrosion inside the
biological organism.

As we know now, from the previous literature review, in order to obtain a metallic
material that will have no reaction with the biological system it will be implanted on, we
must be sure of the biocompatibility of this material and test the corrosion resistance of it.

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Otherwise, we cannot assure a good behavior of the material inside the organism and take the
risk of suffering adverse effects.

Therefore, for the realization of this project, we have decided to test the
biocompatibility of two types of metallic materials: medical grade steel 316L (scalpels) and
commercial metallic materials (metallic nails). With the objective of testing the
biocompatibility of these materials we simulated the biological fluid of the human body with
the use of chicken breasts as our host and other substances as human fluids. Several tests
were carried out, the methods and the analysis of the results obtained are detailed in the
following sections.

3. MATERIALS AND METHODOLOGY.

The following materials were used to meet the objective of this practice:
● 2 chicken breasts
● 3 medical grade scalpel blades № 10
● 3 galvanized nails
● Nylon thread
● Blunt needle
● Salt water (NaCl)
● Acetic acid (vinegar)

To begin the work, 6 pieces of breast were cut from the two breasts that were initially
available. These 6 pieces were then cut longitudinally with one of the medical grade scalpel
blades. The incisions were about 4 cm to place the scalpel blades and about 3 cm to place the
nails.

Three groups of breast pieces were made:

1. Group to which no solution was added (Control)
2. Group to which NaCl solution was added
3. Group to which acetic acid was added
In each group there was a piece of breast with a 316L stainless steel scalpel and a piece with
a galvanized nail.

Once the metals were inserted in the breast pieces, the incisions were closed with a single
stitch suture using a blunt needle because it has a wide enough eye for the nylon thread to
pass through. There were no problems introducing this type of needle into the skin of the
breasts.

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 Figure 2. Breast pieces with the nails inserted and the incision closed with the single stitch
method.

Figure 3. Breast pieces with the scalpel blades inserted and the incision closed with the
single stitch method.

Then, in order to see the effects of the metals within a biological environment (breasts), the
pieces were kept refrigerated for 4 consecutive days and one day at room temperature. At the
end of the fifth day, the metals were extracted for subsequent characterization.

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 Figure 4. Breast pieces with nails inserted after 5 days.

Figure 5. Breast pieces with the scalpel blades after 5 days.

When the metals were removed from the meat, it was no longer viable for use, so the chicken
breasts were deposited in the organic waste.

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 4. RESULTS AND DISCUSSION.
The scalpel and the nail were extracted from the breasts after 5 days, the materials were then
characterized by visual inspection on the stereoscope, and the results shown in figure 6 were
obtained.

Figure 6. As received materials, scalpels and nails prepared for characterization.

4.1 Breasts without solution (control)

According to the observations carried out on the commercial metal (nail), after being 5 days
inside the breast and being exposed to changes in the temperature and the presence of water
residuals inside the host, no changes were observed. As we can note from the results shown
in figure 7, the metallic material has no failures on its surface and does not show any signs of
corrosion. This material appears to have a good biocompatibility, however the reason why no
corrosion was produced is because of its galvanized surface, that gives the material the
characteristic to be corrosión resistant.

Figure 7. Characterization of the galvanized steel (nail).

The inspection of the medical grade material (scalpel) showed different results than the
commercial steel. The as received material even being designed to be used in biological
organisms, like the human body. As it is observed in figure 8, it presented general corrosion
on its surface after being exposed to the host's environment and the water residuals it had. We
noted that the damage on the surface of the material was not extreme after being 5 days inside
the breast.

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 Figure 8.General corrosion presented on the scalpel blade.

4.2 Breasts with NaCl solution

The nail that was sprayed with NaCl aqueous solution showed general corrosion due to the
oxidation of the zinc coating due to the fact that the nail had a galvanized treatment.
However, it can be observed that certain parts present more oxidation than others and this is
due to the microenvironments formed in the difficult geometries of the metal. For example,
the folds at the tip of the nail show a more yellowish coloration than the rest of the surface.

Figure 9. Characterization of the galvanized nail tip.

The scalpel blade that was sprayed with aqueous NaCl solution, like the galvanized nail,
exhibited general corrosion. What happens in this case is that a chromium-rich oxide film
forms along the entire area of the steel sheet and this is where the oxygen atoms penetrate to
reach the metal. Over time this film begins to destroy/oxidize and changes are observed as in
Figure 6.

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 Figure 10 . Characterization of the 316L stainless steel scalpel blade.

NaCl normally causes pitting corrosion in steels, but in this test it is not so easily visualized,
possibly due to the short time that the metals were in contact with the salt.
Due to the degradation of the zinc coating of the galvanized nail, Zn+2 ions are released
which are toxic to living organisms, making it incompatible with biological systems.
In the scalpel blade what happens is that the passive layer of chromium (cathode) begins to
interact with the alkaline environment (anode) producing its degradation. As this degradation
occurs the positive metal ions provide a local excess of positive charge that attracts the
negative chlorine ions of the electrolyte to produce charge neutrality. This results in a high
concentration of MCl molecules that react with the water to produce HCl, metal hydroxide
and H+ ions, accelerating the corrosion process.

4.3 Breasts with Acetic Acid.

Once the scalpel and the nail were extracted from the breasts, then the materials were
characterized on the stereoscope. From this we can discuss the following results:
The scalpel showed general corrosion on all the surface of itself, this is produced by the act of
acetic acid. Acetic acid destroys the passive layers that the stainless steel forms due to the
presence of chromium. Once the passive layer is destroyed the contact of H+ Ions forms a
galvanic cell with the metal acting as an anode. During this electrochemical process the
release of Hydrogen Ions makes the material become active and release ions that in the long
term can generate cytotoxicity within the body, in addition to inducing pitting corrosion due
to the generation of microenvironments in the difficult geometries of the scalpel

A. B.

Figure 11. (A) General corrosion and crevice in the scalpel characterized on the stereoscope
(B) General corrosion of the scalpel

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 On the other hand, we use a nail which is not designed to be a biomaterial,
nevertheless, this type of materials are prepared to be resistant to aggressive environments,
generally this materials are prepared by adding a passive layer that makes them resistant to
corrosion, as it can be seen on the figures this material present general corrosion due to the
partially degradation of the passive layers. Even though the corrosion is less than the one that
happened on the scalpels, this doesn't mean that this material is better. As it was mentioned
earlier this type of materials are prepared for building, but not to be used on the human body.
These materials release metallic ions inside the body which generates cytotoxicity inside the
human body, and it also produces an immune response, rejecting the implant if it is made
from this material.

Figure 12. General corrosion evidenced on a steel nail characterized on the stereoscope.

5. CONCLUSIONS.
● Biomaterials have been developed to replace parts of living systems in the
human body, providing the patient the benefits of increased longevity and
improved quality of life. However, it is mandatory to complete all the research
in order to obtain a biomaterial that will fulfill its expectations. In this project,
we have analyzed the behavior of two types of metallic materials, medical
grade stainless steel and commercial nails, in different environments in order
to identify whether the material is biocompatible or not.

● First, we analyzed the biocompatibility of a scalpel and a nail inside the host
with no solution added. We observed that the as received materials did not
show extreme changes, but the scalpel showed general corrosion on its
surface. This was given because of the amount of time the material was
exposed to this environment and the presence of water residuals inside the
breast, but we can still assure the biocompatibility of the scalpel because of the
minimal change of the material. On the other hand, the nail did not show any

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 kind of corrosion because of its galvanized surface which gives it excellent
corrosion resistance. However, it is not recommended to use this material as a
biocompatible material inside the human body.

● Alkaline solutions and strong acids create an environment where general

corrosion is most likely to occur on stainless steel. Although the corrosion on
the nail is not evident to the naked eye, with its characterization it is seen that
corrosion has started in the difficult geometries which indicates that there is
also release of ions that are toxic to living beings. This indicates that these
metals and types of coatings are not biocompatible.

● The presence of Acid pH within the human body tends to degrade the passive
layers of stainless steel making it an active material which could release toxic
ions inside the body, for this reason it is important to prepare the surface in
order to eliminate difficult geometries or not uniform surfaces which could
promote the creation of crevices on the material, resulting in the formation of
pitting corrosion or other types of corrosion that affects the normal function of
the implant.

6. REFERENCES.

● Ali, S., Rani, A. M. A., Baig, Z., Ahmed, S. W., Hussain, G., Subramaniam,
K., ... & Rao, T. V. (2020). Biocompatibility and corrosion resistance of
metallic biomaterials. Corrosion Reviews, 38(5), 381-402.

● Hiromoto, S. (2019). Corrosion of metallic biomaterials. In Metals for

biomedical devices (pp. 131-152). Woodhead publishing.

● Purnama, A., Hermawan, H., Couet, J., & Mantovani, D. (2010). Assessing
the biocompatibility of degradable metallic materials: state-of-the-art and
focus on the potential of genetic regulation. Acta Biomaterialia, 6(5),
1800-1807.

● Sridhar, T. M., & Rajeswari, S. (2009). Biomaterials corrosion. Corrosion

Reviews, 27(Supplement), 287-332.

● Williams, D. F. (2008). On the mechanisms of biocompatibility. Biomaterials,

29(20), 2941-2953.

● Remes, A., & Williams, D. F. (1992). Immune response in biocompatibility.

Biomaterials, 13(11), 731-743.

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