Chapter 1: Introduction

The spine is the body’s central support structure, which is the part of the axial skeletal system
and made up of a chain of bones. It allows the upper body to take different postures and support
the upper body while that posture is maintained. Protecting the spinal cord, which connects the
brain with the whole body, is another critical function of the spine. The spine has 33 individual
bones and broken up into five sections: the cervical, thoracic, lumbar, sacral, and coccygeal. The
separate section is known as the vertebra. There is an intervertebral disc between two vertebrae,
which act as shock absorbers and allow limited vertebral motion [1].

Every year, between 250,000-500,000 people suffer from spine injuries around the world. Causes
of these injuries can happen due to trauma, such as a car crash, or disease, such as cancer. The
intervertebral discs can also be injured due to degenerative diseases and herniation. Depending
on the severity of these injuries, the damages can range from partial loss of motor and sensory
function to complete paralysis. People with spinal cord injuries are also up to five times more
likely to die prematurely than average [2].

Natural bone has self-repair capability after the damage. The more minor fractures heal
themselves correctly. However, segmental bone defects can lead to permanent paralysis. In such
cases, the grafting technique is used. In early grafting techniques, based on source, these grafts
can be of two types: autograft and allograft. For autograft, the graft is harvested from the
patient’s body. On the other hand, for allograft, the bone graft is harvested from a donor’s body.
Usually, graft technique requires harvesting from non-vital bone, such as the iliac crest.
Autografts and allografts were most commonly used because of their high probability of bone
fusion. However, there are complexities associated with autograft and allograft, such as bone
availability, the mismatch between harvested bone and the affected site. In the case of autograft,
it prolongs the duration of surgery and has the risk of residual pain. On the other hand, for
allograft, along with the risk of bone tissue mismatch, it also carries the risk of transmission of
disease and immunogenic response in the host’s body. Specifically for spinal implants, these are
not always preferable options due to the surgical risks involved [3].

These limitations introduced the other option, using artificial implants as a graft. The concept of
an artificial implant is to use a graft made from different materials where the material should
have physical and chemical properties like bone, good biocompatibility, and osteoconductivity.
Bones are considered a live tissue, and they are composed of various minerals and organic
bodies. Also, the bones keep remodeling themselves constantly throughout the life cycle of the
human. Remodeling of bone also takes place in case of an injury or trauma. Also, this
remodeling is sensitive to any changes made to the site affected by trauma [4]. All these
characteristics, along with their complex shape, make bone a challenging tissue to mimic. Spines
are no different. Many biomaterials have been investigated, and the most attempted implants for
spines are made from materials like metals, polymers, and ceramics. The introduction of additive
manufacturing for implants has launched spine implants into a new era.

History of spinal surgery and implants:

In the early days, spinal surgery trailed the techniques and methods used in other orthopedic
surgeries. But the significant difference between spinal surgeries with other orthopedic surgeries
is the presence of the spinal cord, which is the main part of the central nervous system. Any
damage to the spinal cord during surgery can lead to unwanted consequences in the nervous
system. Before better methods were developed, most spinal surgeries were limited in the lumbar
regions as manipulating the spinal cord in the lumbar region was considered safer than the other
regions. With the modernization of surgery techniques, equipment, and technology, spine
surgery involving implants has become one of the most prevalent types of surgery [2].

Among the earliest surgical interventions was spinal fusion. It became prevalent as a method to
correct deformities in the spine with the rise of deformities occurring from tuberculosis. Later,
some spine injuries were also treated using spinal fusion, which involves taking a bone graft and
fusing it into the injury site. It is also used for injuries and deformities related to intervertebral
discs (IVD). A piece of bone from a different area of the body was taken out and attached to the
back of the spine between the vertebrae to allow a gap for a damaged disc. From there, screws,
cages, and plates can be implemented to help align the graft with the rest of the spine. The spinal
implant will then help with structural support and promote bone healing while immobilizing the
area. These implants generally take three to six months to heal. A second surgery is sometimes
needed to remove the implant, which introduces the risk due to surgery. Metal wires were
sometimes used to attempt to keep the spine stable. Many surgeries would fail because the graft
could not be stabilized until it could bond with the surrounding bone [2].
The implants made with the traditional processes were not consistent with producing the
implants with desirable qualities. With the introduction of additive manufacturing, various
manufacturing limitations of traditional manufacturing processes were addressed. Additive
manufacturing, also known as 3D printing, is a layer-by-layer manufacturing process capable of
manufacturing highly complex shapes with desirable internal intricate structures, like porosity
and other geometry [5]. The most significant advantage that was achieved from additive
manufacturing is that it provides the option of mass customization. Off-the-shelf spine implants
can only have so many variations in dimensions and often require the surgeons to make a
significant modification to fit the implant to the patient while operating. This increases the risk of
the surgery. Additive manufacturing is capable of making patient-specific implants which
increases the chance of having a successful implant. Also, being able to control the internal
structure improved the performance of additively manufactured implants.
Compared to the history of spine surgery with implants, the application of additive
manufacturing is relatively new. After its introduction in the 1990s, initially, additive
manufacturing was used to make accurate replicas of a patients’ spine. This helped the surgeons
to have a better idea about the spine condition and plan their surgery. Also, it enabled them to
have practice on the replica of the spine before doing the actual surgery. This was an innovative
low-cost solution for the surgeons to perform better during the surgery. Another earliest
application of additive technology in spine surgery was to make tool guides for the surgery. This
also helped to perform complicated surgery while minimizing surgery risks by reducing the total
surgical time [6]. When additive manufacturing was introduced to manufacture implants for the
spine, it opened a new avenue for making different types of implants with intricate features.
Many biomaterials were not possible to manufacture with the conventional manufacturing
process. Additive manufacturing made it possible to manufacture implants from various novel
materials that could not have been used earlier.
Moreover, the degree of freedom while manufacturing an implant with 3D printing enabled the
design to be topographically optimized. This can result in higher mechanical strength of the
implant and better integration of the implant at the implant site [7]. Although additive
manufacturing of implant has imparted many revolutionary benefits, many challenges are still in
existence in terms of limitation of materials used and limitation of methods used.
A different area of applications of spinal implants:
Spinal injuries (SI) can happen from traumatic causes such as motor vehicle accidents, falls, acts
of violence, and sports injuries. They can also happen due to non-traumatic causes such as
cancer, arthritis, osteoporosis, inflammation, and other diseases [8]. These injuries can lead to
conditions such as fractures, spondylolisthesis, and degenerative disc disease, which may require
a spinal implant.

Spinal implants can be used to to correct different irregularities in the spine. For example, it can
be used to correct deformities like the spondylolisthesis and isthmic spondylolisthesis.
Spondylolisthesis can occur due to a defect at birth, called congenital, where an infant’s spine
does not form the way it should before birth. The other type is called isthmic spondylolisthesis,
which is often the result of spondylolysis. Spondylolysis is a fracture in the pars interarticularis,
a weak bone at the posterior of every vertebra that forms the spinal column. When this fracture,
the affected vertebra is no longer bound to the spinal column and can slip forward over the one
beneath it. In these cases, a spinal implant is used [9].

Another application of spinal implant is to strengthen and improve the stability of the spine. This
often occurs in the lumbar region as the lumbar spine supports more weight than the sections
above it. It also needs to bend and rotate in all different directions during physical activity. The
weight of the upper body and the lower spine's movement can create an excessive amount of
stress and strain [10].

A spinal implant is also used for treating degenerative disc diseases [5]. In such cases, an
artificial disc is used to restore the gap between the two vertebrae. Often spinal fusion is done
with this, which eliminates the mobility of the segment. Another application of implant is to treat
spine fractures. Severe fractures often lead to replacing the whole vertebra and place an implant.
In most cases, these implants are in scaffold shape and screwed to the place.

What are the general challenges of spinal implants?

One challenge common for almost all implants is the variation of size and shape of the same
tissue part of humans. On top of that, inherently spine is a complex shape of the vertebral
column. Although the basic shape is the same for all human beings, the size of the spine differs
from person to person, and even in the same person, the individual bone, known as vertebra,
differs. This makes it challenging to make an off-the-shelf implant suitable for everyone.

Also, making the implant mechanically stable is another challenge. Other than mechanical means
like screws to hold the implants in place, the material of the implants needs to exhibit some
particular properties like biostability, osseointegration, osteoconduction for better cellular
anchorage. Also, bone implants need to have a porous structure to facilitate the exchange of the
metabolic substances. The porosity, pore size and pore interconnectivity; all of these are
important factor to the performance of an implant. Lack of this can impair the capacity of the
osseointegration [11]. The traditional manufacturing process is not capable enough to reliably
make this required porous structure. Also, it is limited by the shape it is capable of producing.
The introduction of additive manufacturing has made it possible to manufacture complex shapes
with controllable porous structures. Nevertheless, it comes with its own time and cost penalty.

In essence, the spinal implants themselves must have properties that share characteristics of bone
in the spine. This compatibility and longevity are crucial for the implant to work accordingly. On
top of functionality, manufacturability and cost efficiency are the primary challenge for a spinal
implant.

Chapter 2: Existing Challenges in spinal implants:

When creating a spinal implant, the implant must have properties that mimic bones. The main
properties of the bone that need to be present in the implant are chemistry, porosity, geometry,
and mechanical properties [12]. If the implant changes the spine/spinal area's chemical balance,
the body may reject the implant and use the immune system to fight against it. Mechanical
properties like tensile and flexion strength should be precise when manufacturing spine implants.
If the implant has too much tensile strength, it may get too brittle to be used as a bone
replacement. Flexion strength is a crucial component for a spine implant since the spine is used
for many stretching movements like bending down, turning the upper body around, reaching up,
and moving the head. Geometry is one of the more complex properties of implants. Spinal
implants are challenging to make because each bone defect is unique, so the implant's shape has
to be unique. Porosity is another essential factor when it comes to osteoconductivity. If the
implant is not porous enough, the surrounding bone tissue will not be able to grow in the
implant.

Many of the challenges in making spine implants stem from finding the best properties to match
the bone characteristics of the spine. For example, porosity is a characteristic of the spine, and it
is also one of the driving factors in determining cellular attachment with the surrounding tissue.
Another factor that may affect the compatibility is the type of material that is chosen for the
implant. When dealing with an implant's longevity, metal might be the best material since it will
stay in the body longer [13]. The metal implants have higher strengths which can lead to stress
shielding and eventually to osteolysis. Also, the long-term effect of metal implants and their
possible metal ion release is a concern because of their possible cytotoxicity. On the other hand,
biopolymers or bioceramics have closer strength properties to bones but often suffer from other
issues. For example, biopolymers can break down into acidic materials, which can cause
inflammation, and bioceramics can be very brittle. The common problem that all three materials
suffer from is the mating nature at the interface to prevent loosening. In a moving joint, the
material has to sustain frictional wear and hold its shape necessary for bone anchoring.

Manufacturability is another significant challenge when it comes to spinal implants. Additive

manufacturing techniques like stereolithography (SLA), selective laser sintering (SLS), and
fused deposition modeling (FDM) have all been used to create implants [12]. Based on the
material (or materials) selected, each process can be a viable option when creating the implants.
The issue that is prevalent with spinal implants is that doctors do not have the time to create a
unique implant for each patient. Currently, surgeons are using standard implants for every patient
[14]. Creating and printing a unique implant would increase the time it would take for the patient
to receive the implant. However, since the surgeons are using standard implants, there might be
more risk of reinjury involved. Finally, the cost of 3D printing implants has been too high to
deem it viable. This has started to change because the cost of 3D printers and biomaterials has
been decreasing due to more interest and research in the field. Still, the costs are high enough to
accept them as a primary option in implant surgery.

To summarize, many studies have been done in this area, but there are still several key issues to
solve. The challenge remains to make an implant that is biocompatible and biostable, promotes
osseointegration, osteoconduction, preferably osteoinduction, has the similar strength of the
bone, and maintains its mechanical properties throughout its lifetime. The implant's high cost due
to the material and the printing process is a barrier for many patients and other applications like
veterinary applications. In the next section, we will identify the materials that have been used for
making spinal implants and identify their limitations and propose our solution.

Chapter 3: Materials used in spinal implants and their prospects and limitations
1. Metals:
Most spinal implants are currently designed using metals such as Titanium, Titanium alloys, and
Magnesium as materials. One of the main advantages that come with the use of metals is their
ability to be cellularly designed to fit specific performance and mechanical requirements. One of
the main disadvantages to metallic implants is the additive manufacturing process.

Perhaps one of the most popular materials used in metallic implants is titanium and titanium
alloys. Titanium alloys, in particular, have undergone a ton of recent developments for
biomedical applications, with some areas including processing, microstructures, and properties.
Some of the titanium alloy properties include a low elastic modulus, high specific strength,
excellent corrosion resistance, and superior biocompatibility [15]. These properties are essential
for functioning in the body as it allows the metallic implant to function in the body without
activating a response from the body. The high strength and corrosion resistance allow it to stay in
the body for more extended periods of time. Nevertheless, a mismatch of strength at the implant
interface and the bone can lead to stress shielding.

The two types of titanium alloys that were researched were alpha-type and beta-type titanium
alloys. The alpha-type titanium alloys were the ones that were first looked into for biomedical
implants. However, they possess low strength and poor wear resistance, which ruled them out as
potential materials for implants. An (α + β) combination was looked into next. Although they
possess higher mechanical properties than the alpha type, they possess a modulus higher than
that of bone and contains harmful elements (Al and V) that could be bad for the body [15].
Finally, the β-type titanium alloy was looked into. It was discovered that a low elastic modulus
beta-type titanium alloy with a non-toxic element (Nb, Zr, Ta, and Sn) could be used in
biomedical applications.

For additive manufacturing processes, there are a limited number of processes when compared to
other materials. The additive manufacturing processes for metals are limited to selective laser
melting, electron beam melting, and powder bed fusion techniques (such as SLS and SLM) [15],
[16]. While there are other additive manufacturing processes (such as FDM), which can produce
parts at low parts, the problem is that the parts produced by FDM possess low mechanical
properties, which is not ideal for implants in the body [16]. Another disadvantage of additive
manufacturing techniques for metals area lack of suitable alloy design, insufficient densification,
and wear resistance [17]. These require further studies to determine their effectiveness.
Magnesium is a potential ideal bioabsorbable material for implants. When used as an alloy,
Magnesium has no toxicity within the human body as it corrodes. The disadvantage to this is the
corrosion rate. Magnesium degrades at a relatively rapid rate, quicker than the healing process
that bone needs to regenerate at [18]. In a study about joint injuries to the ACL ligament,
Magnesium based screws were tested to see the advantages and disadvantages of its clinical use.
Mechanical strength has been an obstacle for Magnesium, but the experiment showed that alloy-
based screws used for implants showed promising results in stress shielding and biocompatibility
[19]. One of the biggest disadvantages magnesium poses for implants is the additive
manufacturing process. Because of the reactivity of Magnesium, 3D printing is complex. The
high surface energy and electronegativity of the material pose a problem with printing because of
its rapid corrosion rate [20]. SLM is one of the few additive manufacturing processes that offer
porosity of pores within the structure of magnesium implants [21]

Recent findings have shown that Zinc alloys could be a possible candidate for bone implants.
Zinc has good biocompatibility properties as minor amounts of it can be found within the human
body. Its cytotoxicity is found to be good with both amorphous and crystalline film structures
[22]. However, Zinc has a high corrosion rate similar to that of Magnesium, which poses
difficulty for cell regeneration [18], [22]. Zinc compounds have been found to give good
mechanical properties similar to bone. Gold magnesium-based alloys showed that different
microstructure sizing results in better stress shielding when applied with bone tissue [23].
However, to gain this material, additive manufacturing is ruled out of the system. Zinc having
similar properties to Mg means similar obstacles to its 3D printing capabilities. [20], [21].

The primary concern with using metal implants is the possibility of stress shielding, which
eventually leads to osteolysis due to their comparatively high mechanical strength. As the effect
of osteolysis cannot be realized immediately, it is often not considered for metal implants.

2. Biopolymers:
Synthetic polymers are typically fabricated into scaffolds for bone regeneration because of their
biocompatibility, biodegradability, low toxicity, mechanical properties, and ease of processing.
Polymers contribute to bone regeneration by providing support when implanted before slowly
degrading as the new tissue forms [24]. This diminishes the need for a second surgery to remove
the implant, leading to lower patient risk and cost. However, there will be challenges with using
a polymer if a long-lasting implant is needed because they are biodegradable [25]. Polymers also
cannot cause bone ingrowth by themselves. Another material that is bioactive must always be
added to the polymer in order for the implant to be osteoconductive. This material is usually a
metal, ceramic, or bioglass [24], [26], [27].

Some of the most common polymers used for implants are polycaprolactone (PCL), polylactic
acid (PLA), poly(lactic-co-glycolic) acid (PLGA), poly trimethylene carbonate (PTMC),
polyetheretherketone (PEEK) [25]. Where PLA, PCL, and PLGA are approved by the FDA for
implantation and contact with biologic tissue. [24], [26].

Polycaprolactone (PCL) is a more common polymer used in bone tissue engineering because it is
a thermoplastic polymer with good biocompatibility and mechanical properties compatible with
cartilage and bone regeneration. It is considered an ideal material for hot extrusion techniques
like additive manufacturing because of its low melting point and high decomposition point. PCL
is beneficial for long-life implants because of its slow in vivo degradation. After two years, it can
be completely resorbed. However, acidic products are released during degradation, causing low
cell proliferation and inflammation [26].

Polylactic acid (PLA) is also a common bone regeneration material because of its high elastic
modulus [25]. However, it exhibits lower bioactivity than spine bone which limits its use for
spinal implants. However, when mixed with poly(glycolic acid) (PGA) fibers and HA, the tensile
and flexural strength increases along with the rate of new apatite growth on the surface. This
combination could potentially be used in spinal implants. Furthermore, PLA can easily be
manufactured with low-cost 3D printers without decreasing the quality. But PLA’s degradation
products are also cytotoxic because of the acidity, similar to PLA. The byproducts can cause
inflammation and bone resorption [25], [26].

Poly(lactic-co-glycolic) acid (PLGA) is similar to PLA with a degradation rate and mechanical
properties compatible with many bone tissue engineering applications. Its degradation products
are not toxic but can still release acidic products resulting in local inflammation and bone
resorption [25]. PLGA also has a high melting point which can affect the printing process. PLGA
fibers and sutures could reinforce an adhesive matrix and act as pore-generating agents that leave
interconnected channels after degradation. This could promote more efficient bone ingrowth and
better cell infiltration. When testing PLGA fibers on spines in vivo, the implant could handle
stress levels that were four times higher than standard intervertebral discs [28]. 

Polyetheretherketone (PEEK) is one of the more common materials used for spinal
fusions/interbody cages. It is often used as a replacement for metal because of its temperature
resistance, biocompatibility, and high tensile strength [29]. PEEK has a Young modulus close to
the native bone and an elastic modulus lower than cortical bone, limiting the piston effect and
stress shielding that happens with titanium. Its mechanical properties, chemical resistance, and
radiolucency make it ideal for tissue application [27]. PEEK implants also appear transparent in
X-rays, making checking in on the implant easier. Carbon fiber can also be added to the PEEK
for high load applications, but this could lead to less flexibility, resulting in a more brittle
implant. PEEK is considered challenging to print because there have not been too many 3D
printers that can print PEEK readily available on the market in the past. Higher nozzle
temperatures will be required to print PEEK due to its high melting point, similar to PLGA.
PEEK is also a semi-crystalline polymer, meaning the mechanical properties increase when the
crystal levels are higher. However, crystallization can cause the part to shrink and warp if there is
not a homogenous temperature across the part [29].

Poly trimethylene carbonate (PTMC) is another polymer that can be useful for implants. Among
the polymers, it is known for its biocompatibility and bioresorbability, but, like other polymers,
PTMC needs another material to be osteoconductive. [30]

3. Bioceramics:
Bioceramics are one of the most used biomaterials after metals and biopolymers after metals in
bone implant application due to their inherent biocompatible nature. Their primary advantages
come from their chemical composition, which influences their integration in complex tissues,
specifically bones [31], [32]. Whereas many implants made from other materials resulted in a
bodily response of generating disruptive connective tissues in the implant site, bioceramics
showed the ability of osteointegration without producing the disrupting layer of connective
tissues [33]. For minor defects, bioceramics have shown excellent results due to their
absorbability by regeneration of bone in the defects. This bone generation can take place inside
the implant if provided with porosity and its surroundings. [33], [34]. The most commonly used
bioceramics are Hydroxyapatite, Beta tri-calcium phosphate, and different types of bioactive
glasses. However, their applications are heavily restricted by their mechanical properties, which
are not appropriate for the large load-bearing sites like the femur, or in our case, the spine [35].
Hydroxyapatite Ca10(PO4)6(OH)2 is one of the inorganic components present in human bones in
biform. This provides Hydroxyapatite a natural advantage by exhibiting excellent
biocompatibility and bioactivity. However, the mechanical properties of the Hydroxyapatite are
not good enough to make a stand-alone implant from it. Therefore, it has mostly been used as a
coating on implants to improve the surface characteristics of the implant. HA has been usually
used for the surface coating on Ti-based implants or polymer implants in order to obtain
materials that possess both bioactivity and mechanical resistance [36]. Also, Hydroxyapatite only
increases the bio-adhesion and mechanical fixation. This coating cannot inhibit the release of
metal ion and have surface corrosion risks [37]. Furthermore, extensive research has been done
in 3D printing of HA and HA Based materials, but there are still challenges to make load-bearing
implants for hard tissue application. [38]
Tricalcium phosphate is another material that can closely mimic the chemical structure of the
bone. Most commonly, there have been two different phases of tricalcium phosphates α and β,
but due to the aggressive biodegradation, α-tricalcium phosphate is not used in the bone implant.
On the other hand, a scaffold-like implant made from β-TCP displays superior osteogenesis,
cellular compatibility, and nonimmunogenic response [3]. But tricalcium phosphate is also
challenged by inherent disadvantages like brittleness and difficulty in printing complex shapes.
Furthermore, in most cases, they can’t be additively manufactured directly by the available
processes and need to be manufactured additively by combining with other materials [35],[39].
This results in requiring post-processing of the part, which increases the production time too.
The other type of bioceramics that are used for bone implants is Bioactive glasses. They often
contain different oxides of sodium, calcium, and silicon. Their property can be controlled by
controlling their composition, and the content of silica is the primary material that influences
their biocompatibility [40]. There have been attempts to improve their biocompatibility by
adding different coating materials that showed promising results in simulated conditions.
Additive manufacturing has enabled bioactive glasses to be printed in intricate implant shapes
for bone fractures. Nevertheless, bioactive glasses' applications are very limited to teeth implants
and other small bone fractures that are not load-bearing sites. This limitation arises from their
brittleness and inferior mechanical properties [41].
In the following table, we compared the different aspects of the materials that have been in use
for spinal implants.
Table 1: Comparison between various materials for spinal implants
Material Advantages Disadvantages Available AM
Techniques
Metal 1. High mechanical 1. Stress Shielding 1. Selective Laser
strength leading to Sintering (SLS)
2. High specific strength osteolysis 2. Selective laser
3. Easily alloyed to 2. Probability of melting (SLM)
enhance property corrosion
3. Expensive
4. Possibility of
releasing toxic
metal ion in the
body
5. Radiopaque
Biopolymers 1. Lightweight 1. Comparatively 1. Stereolithography
2. Biocompatible lower strength (SLA)
3. Radiolucent than metal 2. Fused Deposition
4. Relatively inexpensive 2. Low Modeling (FDM)
5. It can be easily coated osseointegration,
osteoinduction
property
3. Degradation
product can be
cytotoxic
Bioceramics 1. Relatively inexpensive 1. Brittleness 1. Stereolithography
2. Biocompatible. High 2. Comparatively (SLA)
osseointegration, difficult to 2. Fused Deposition
osteoinduction, and manufacture Modeling (FDM)
osteoconduction with the
property available 3D
3. Wear-resistant printing
4. Have similar strength to techniques
cortical bones 3. Require post-
processing for
implants made
by additive
manufacturing

From the literature review of the materials that are being in use for spinal implants, it can be said
that no single material can deliver on all the requirements of desired implant quality. Moreover,
in most cases, implants are only made in the shape of the scaffold instead of the shape of the
component it will replace. This reduces the surface area of contact. Studies have shown that the
surface delivers the anchoring space on which the cell proliferates [42]. Thus, having a higher
surface area by being the shape of the bone has a higher potential for integration of the implant.
From our literature review findings, we have identified that several key issues need to be
addressed. They are as follows:
1. No vertebral spinal implant has been made to mimic the shape of the bone itself. We
hypothesize that replicating the vertebra to the actual shape like other implants will result
in better surface area for cellular adhesion, which has the potential for a substantial
positive impact on the implant’s cellular anchoring.
2. Most of the vertebral implant sacrifices mobility of the segment of implantation after
surgery.
3. Although metal implants are considered to be an industry standard, there is a lack of
long-term study about their impact on stress shielding. Avoiding metals also can
eliminate the risk of the cytotoxicity that can cause by released metal ions altogether.
4. There has been no study based on the particular combination of shape memory polymer
and bioceramics or biopolymers that show closer strength to human bone.
5. The cost of the implant is a barrier for many patients and a barrier to expanding the
application to other animals, particularly pets like canines and felines.

To address these issues, we propose to print an implant with the primary shape built from
suitable bioceramics or biopolymers with layers of suitable shape memory polymers (SMP).
Shape memory polymers deliver some significant advantages for using it as a bone implant. In
the next section, we will describe the possible benefits of our proposal.

Proposed benefits from our solution:

For an implant to be considered as a long-term solution should have a very long lifetime. Also,
being a live tissue, it is known that the bone remodels itself every almost every ten years [43].
So, a mismatch in the mechanical property can lead to osteopenia and osteolysis. This makes
strong materials like metals an undesirable choice. Also, eliminating the use of metals removes
the chances of any cytotoxicity from possible metal ion release. These are the primary reasons
for us to choose bioceramics or biopolymers as the implant's main structure. Another vital
advantage of using bioceramics or biopolymers as the core material is that they will closely
mimic the bone characteristics. So, they have a reduced chance of stress shielding. We are
proposing to use a coating of shape memory polymer on the shape.
Shape memory polymers are comparatively low-cost and lightweight [44]. They can be
processed easily while showing excellent potential for biocompatibility. Their biocompatibility
has been tested in animals. This is very important as this biopolymer needs to function
adequately in our body without generating any immunogenic response.
One other unique benefit of using shape memory biopolymers is that they possess a self-healing
factor. One of our goals for this implant is to retain the operated section's mobility even after the
surgery. As the vertebral implants will be under stress and motion, the self-healing effect can
ensure the implant's longevity and eliminate future subsequent surgeries. Finally, the advantage
that can be harnessed from the SMPs is their shape memory property. In general, the shape
memory polymers showed better shape-memory performance than the most commonly used
shape memory alloys like Nitinol. They can show recoverable strains of up to more than 200%
[44].
Finally, we hypothesize that due to the trainable shape-memory of the implant, it is possible to
have a deployable structure with outer contour created by SMP, which can decrease surgical
invasiveness while increasing patient comfort [45].
Another benefit that can arise from our choice of material is the economic aspect of the implant.
The additive printing of metal implants generally uses the Selective Laser Sintering (SLS) or
Selective Laser Melting (SLM) process, which are generally available in commercial versions
and drives up the cost. On the other hand, it is possible to print our choice of materials in our
desired shape with repeatability using the Fused Deposition Modelling (FDM) and
Stereolithography (SLA). Using an available process to meet the need can drive down the
implant's cost and make it more accessible. Also, this can potentially open new market segments
where the high cost of the implant was a barrier.
[1] “Spinal Anatomy Center | Cervical, Thoracic, and Lumbar Spine Info.”
https://www.spineuniverse.com/anatomy (accessed Mar. 25, 2021).
[2] “The History of Spine Surgery | New Jersey Spine & Orthopedic.”
https://www.njspineandortho.com/history-spine-surgery/ (accessed Mar. 26, 2021).
[3] Y. Cao, L. Xiao, Y. Cao, A. Nanda, C. Xu, and Q. Ye, “3D printed β-TCP scaffold with
sphingosine 1-phosphate coating promotes osteogenesis and inhibits inflammation,”
Biochem. Biophys. Res. Commun., vol. 512, no. 4, pp. 889–895, May 2019, doi:
10.1016/j.bbrc.2019.03.132.
[4] “Bone Development | Boundless Anatomy and Physiology.”
https://courses.lumenlearning.com/boundless-ap/chapter/bone-development/ (accessed
Mar. 26, 2021).
[5] T. Serra et al., “Design and fabrication of 3D-printed anatomically shaped lumbar cage for
intervertebral disc (IVD) degeneration treatment,” Biofabrication, vol. 8, no. 3, pp. 1–10,
2016, doi: 10.1088/1758-5090/8/3/035001.
[6] B. Wilcox, R. J. Mobbs, A.-M. Wu, and K. Phan, “Systematic review of 3D printing in
spinal surgery: the current state of play,” J. Spine Surg., vol. 3, no. 3, pp. 433–443, 2017,
doi: 10.21037/jss.2017.09.01.
[7] A. A. Vu, D. A. Burke, A. Bandyopadhyay, and S. Bose, “Effects of Surface Area and
Topography on Mechanical Properties of 3D Printed Tricalcium Phosphate Scaffolds for
Osteoblast Proliferation in Bone Grafting Applications,” Addit. Manuf., vol. 39, no.
December 2020, p. 101870, 2021, doi: 10.1016/j.addma.2021.101870.
[8] “Spinal cord injury - Symptoms and causes - Mayo Clinic.”
https://www.mayoclinic.org/diseases-conditions/spinal-cord-injury/symptoms-causes/syc-
20377890 (accessed Apr. 01, 2021).
[9] “Diagnosing Spondylolysis I Symptoms & Treatment Options.”
https://www.spinemd.com/what-we-treat/back/spondylolysis/ (accessed Apr. 01, 2021).
[10] “Spondylolisthesis Center - Exercises Treatments Surgery.”
https://www.spineuniverse.com/conditions/spondylolisthesis (accessed Apr. 01, 2021).
[11] E. A. Lewallen et al., “Biological strategies for improved osseointegration and
osteoinduction of porous metal orthopedic implants,” Tissue Engineering - Part B:
Reviews, vol. 21, no. 2. Mary Ann Liebert Inc., pp. 218–230, Apr. 01, 2015, doi:
10.1089/ten.teb.2014.0333.
[12] Y. Chen, W. Li, C. Zhang, Z. Wu, and J. Liu, “Recent Developments of Biomaterials for
Additive Manufacturing of Bone Scaffolds,” Adv. Healthc. Mater., vol. 9, no. 23, p.
2000724, Dec. 2020, doi: 10.1002/adhm.202000724.
[13] P.-I. Tsai et al., “Additive-manufactured Ti-6Al-4 V/Polyetheretherketone composite
porous cage for Interbody fusion: bone growth and biocompatibility evaluation in a
porcine model,” BMC Musculoskelet. Disord., vol. 22, no. 1, p. 171, Dec. 2021, doi:
10.1186/s12891-021-04022-0.
[14] “3D Spinal Implants: A Glimpse into the Future.”
https://www.spineuniverse.com/resource-center/spinal-cancer/3d-spinal-implants-glimpse-
future (accessed Mar. 31, 2021).
[15] L. Zhang and L. Chen, “A Review on Biomedical Titanium Alloys: Recent Progress and
Prospect,” Adv. Eng. Mater., vol. 21, no. 4, p. 1801215, Apr. 2019, doi:
10.1002/adem.201801215.
[16] L. Yuan, S. Ding, and C. Wen, “Additive manufacturing technology for porous metal
implant applications and triple minimal surface structures: A review,” Bioact. Mater., vol.
4, pp. 56–70, Dec. 2019, doi: 10.1016/j.bioactmat.2018.12.003.
[17] H. Attar, S. Ehtemam-Haghighi, N. Soro, D. Kent, and M. S. Dargusch, “Additive
manufacturing of low-cost porous titanium-based composites for biomedical applications:
Advantages, challenges and opinion for future development,” J. Alloys Compd., vol. 827,
p. 154263, Jun. 2020, doi: 10.1016/j.jallcom.2020.154263.
[18] P. C. Banerjee, S. Al-Saadi, L. Choudhary, S. E. Harandi, and R. Singh, “Magnesium
implants: Prospects and challenges,” Materials, vol. 12, no. 1. MDPI AG, p. 136, Jan. 03,
2019, doi: 10.3390/ma12010136.
[19] Y. Luo et al., “Clinical translation and challenges of biodegradable magnesium-based
interference screws in ACL reconstruction,” Bioactive Materials, vol. 6, no. 10. KeAi
Communications Co., pp. 3231–3243, Oct. 01, 2021, doi:
10.1016/j.bioactmat.2021.02.032.
[20] R. Karunakaran, S. Ortgies, A. Tamayol, F. Bobaru, and M. P. Sealy, “Additive
manufacturing of magnesium alloys,” Bioactive Materials, vol. 5, no. 1. KeAi
Communications Co., pp. 44–54, Mar. 01, 2020, doi: 10.1016/j.bioactmat.2019.12.004.
[21] Y. Wang et al., “Challenges and Solutions for the Additive Manufacturing of
Biodegradable Magnesium Implants,” Engineering, vol. 6, no. 11, pp. 1267–1275, Nov.
2020, doi: 10.1016/j.eng.2020.02.015.
[22] N. Annonay et al., “Thin films of binary amorphous Zn-Zr alloys developed by magnetron
co-sputtering for the production of degradable coronary stents: A preliminary study,”
Bioact. Mater., vol. 3, no. 4, pp. 385–388, Dec. 2018, doi:
10.1016/j.bioactmat.2018.05.004.
[23] M. Wątroba, W. Bednarczyk, J. Kawałko, and P. Bała, “Fine-tuning of mechanical
properties in a Zn–Ag–Mg alloy via cold plastic deformation process and post-
deformation annealing,” Bioact. Mater., vol. 6, no. March, pp. 3424–3436, Oct. 2021, doi:
10.1016/j.bioactmat.2021.03.017.
[24] S. Wang et al., “The impact of Zn-doped synthetic polymer materials on bone
regeneration: a systematic review,” Stem Cell Res. Ther., vol. 12, no. 1, p. 123, Dec. 2021,
doi: 10.1186/s13287-021-02195-y.
[25] I. Manavitehrani et al., “Fabrication of a Biodegradable Implant with Tunable
Characteristics for Bone Implant Applications,” Biomacromolecules, vol. 18, no. 6, pp.
1736–1746, Jun. 2017, doi: 10.1021/acs.biomac.7b00078.
[26] J. Babilotte, V. Guduric, D. Le Nihouannen, A. Naveau, J. Fricain, and S. Catros, “3D
printed polymer–mineral composite biomaterials for bone tissue engineering: Fabrication
and characterization,” J. Biomed. Mater. Res. Part B Appl. Biomater., vol. 107, no. 8, pp.
2579–2595, Nov. 2019, doi: 10.1002/jbm.b.34348.
[27] K. C. McGilvray et al., “Evaluation of a polyetheretherketone (PEEK) titanium composite
interbody spacer in an ovine lumbar interbody fusion model: biomechanical,
microcomputed tomographic, and histologic analyses,” Spine J., vol. 17, no. 12, pp. 1907–
1916, Dec. 2017, doi: 10.1016/j.spinee.2017.06.034.
[28] A. Kirillova, O. Nillissen, S. Liu, C. Kelly, and K. Gall, “Reinforcement and Fatigue of a
Bioinspired Mineral–Organic Bioresorbable Bone Adhesive,” Adv. Healthc. Mater., vol.
10, no. 2, p. 2001058, Jan. 2021, doi: 10.1002/adhm.202001058.
[29] C. Rehekampff, A. Schroeffer, F. Irlinger, and T. C. Lueth, “Influence of Infill Structures
and Process Parameters on the Tensile Strength of 3D-printed PEEK Parts,” in 2019 IEEE
International Conference on Robotics and Biomimetics (ROBIO), Dec. 2019, pp. 1633–
1338, doi: 10.1109/ROBIO49542.2019.8961457.
[30] K. E. G. Dienel, B. van Bochove, and J. V. Seppälä, “Additive Manufacturing of
Bioactive Poly(trimethylene carbonate)/β-Tricalcium Phosphate Composites for Bone
Regeneration,” Biomacromolecules, vol. 21, no. 2, pp. 366–375, Feb. 2020, doi:
10.1021/acs.biomac.9b01272.
[31] L. L. Hench, “Bioceramics and the origin of life,” J. Biomed. Mater. Res., vol. 23, no. 7,
pp. 685–703, Jul. 1989, doi: 10.1002/jbm.820230703.
[32] W. Habraken, P. Habibovic, M. Epple, and M. Bohner, “Calcium phosphates in
biomedical applications: Materials for the future?,” Materials Today, vol. 19, no. 2.
Elsevier B.V., pp. 69–87, Mar. 01, 2016, doi: 10.1016/j.mattod.2015.10.008.
[33] M. Bohner et al., “Characterization and distribution of mechanically competent
mineralized tissue in micropores of β-tricalcium phosphate bone substitutes,” Mater.
Today, vol. 20, no. 3, pp. 106–115, Apr. 2017, doi: 10.1016/j.mattod.2017.02.002.
[34] L. E. Rustom, M. J. Poellmann, and A. J. Wagoner Johnson, “Mineralization in
micropores of calcium phosphate scaffolds,” Acta Biomater., vol. 83, pp. 435–455, Jan.
2019, doi: 10.1016/j.actbio.2018.11.003.
[35] T. Zhou et al., “SLA 3D printing of high quality spine shaped β-TCP bioceramics for the
hard tissue repair applications,” Ceramics International, vol. 46, no. 6. pp. 7609–7614,
2020, doi: 10.1016/j.ceramint.2019.11.261.
[36] L. M. Muresan, “Corrosion Protective Coatings for Ti and Ti Alloys Used for Biomedical
Implants,” in Intelligent Coatings for Corrosion Control, Elsevier Inc., 2015, pp. 585–
602.
[37] I. Hamann, U. Hempel, C. Rotsch, and M. Leimert, “Biological cell investigation of
structured Nitinol surfaces for the functionalization of implants,” Materials (Basel)., vol.
13, no. 15, pp. 1–12, 2020, doi: 10.3390/MA13153264.
[38] A. Kumar, S. Kargozar, F. Baino, and S. S. Han, “Additive Manufacturing Methods for
 Producing Hydroxyapatite and Hydroxyapatite-Based Composite Scaffolds: A Review,”
Frontiers in Materials, vol. 6. Frontiers Media S.A., p. 313, Dec. 17, 2019, doi:
10.3389/fmats.2019.00313.
[39] S. Esslinger et al., “Additive manufacturing of β-tricalcium phosphate components via
fused deposition of ceramics (FDC),” Materials (Basel)., vol. 14, no. 1, pp. 1–14, 2021,
doi: 10.3390/ma14010156.
[40] M. J. Zafar, D. Zhu, and Z. Zhang, “3D Printing of Bioceramics for Bone Tissue
Engineering,” Materials (Basel)., vol. 12, no. 20, p. 3361, Oct. 2019, doi:
10.3390/ma12203361.
[41] S. Fu, X. Du, M. Zhu, Z. Tian, D. Wei, and Y. Zhu, “3D printing of layered mesoporous
bioactive glass/sodium alginatesodium alginate scaffolds with controllable dual-drug
release behaviors,” Biomed. Mater., vol. 14, no. 6, p. 065011, Oct. 2019, doi:
10.1088/1748-605X/ab4166.
[42] S. Wei et al., “Effect of surface roughness on osteogenesis in vitro and osseointegration in
vivo of carbon fiber-reinforced polyetheretherketone-nanohydroxyapatite composite,” Int.
J. Nanomedicine, p. 1425, Feb. 2015, doi: 10.2147/IJN.S75557.
[43] “Bone Health Basics - OrthoInfo - AAOS.” https://orthoinfo.aaos.org/en/staying-
healthy/bone-health-basics/ (accessed Mar. 30, 2021).
[44] C. Liu, H. Qin, and P. T. Mather, “Review of progress in shape-memory polymers,” J.
Mater. Chem., vol. 17, no. 16, pp. 1543–1558, Apr. 2007, doi: 10.1039/b615954k.
[45] A. Kashirina, Y. Yao, Y. Liu, and J. Leng, “Biopolymers as bone substitutes: a review,”
Biomater. Sci., vol. 7, no. 10, pp. 3961–3983, 2019, doi: 10.1039/C9BM00664H.