Interfacing 3D printed casts and LIPUS

treatment for improved bone healing

By Angelo Saorin Filho and Matthew Grasso

I. ABSTRACT: Healing a broken bone can be a challenging and extended process, mostly because there
is a need to immobilize the fracture for more than one month, and during this period there can be no loads
applied to it. Not only there is the physical restrainment, the longstanding method by which fractures are
immobilized is uncomfortable, using a heavy plaster cast which cannot be wet and usually results in pale
skin with a large amount of dead cells, due to the fact that it cannot be washed and is not exposed to
sunlight. Along with the discomfort and debilitation of plaster casts, many fractures have impaired
healing, which can result in serious complications. One particular concern is that of delayed-unions and
non-unions. As the mechanisms behind bone healing remain unclear, there is a need for a functional
improvement in the way bone fractures are handled, and the healing process is maintained.
Studies show that low intensity pulsed ultrasound (LIPUS) accelerates and improves bone healing. LIPUS
treatment is an effective, safe and non-invasive way to treat cases of non-union fractures. Also, with
todays 3D printing technology, its becoming easier to manufacture highly individualized devices. Some
designers have already successfully printed 3D cast prototypes. Our objective is to link the benefits of
LIPUS treatment to the 3D printed cast technology.
II. SPECIFIC AIMS:
1) Create a comfortable and easy-to-use 3D printed plastic cast that completely immobilizes
the fractured bone while improving comfort and reducing the inconvenience of plaster
casts.
2) Develop a device capable of low-intensity pulsed ultrasound which can interface with our
3D printed plastic cast.
3) Understand and optimize the best setup for LIPUS treatment in terms of, how long should
it be applied duration of application, what specific intensity, frequency, time of use, and
the best pulse-ratio.
III. BACKGROUND AND SIGNIFICANCE: Each year in the United States there are 6.2 million bone
fractures. The current treatment involves fixing the bone in place with a plaster cast for at least a month.
These casts are debilitating as they cant be exposed to water, are heavy, and conceal the skin resulting in
potential infections and general discomfort. Alternatives to this method have been considered by way of
3D printed plastic casts. These are lighter weight, and healthier options for the skin. They can also be
exposed to water and allow the skin exposure to the atmosphere.
Approximately 5-10% of fractures sustained in the United States are associated with delayed or nonunions, which can become chronic ailments, and usually require surgery. These occur when the healing
process of the bone is in some way impaired and there is not a complete or timely fusion of the bones.
These surgical operations are often invasive, technically difficult, and entail complications associated
with any surgical intervention. Both decreasing the number of fractures that result in delayed- and nonunions, and improving the treatment of chronic non-unions would improve medicines ability to treat these
injuries.

One treatment option which has been shown to significantly improve bone healing of both recent
fractures and chronic non-unions is low intensity pulsed ultrasound (LIPUS). The exploration of LIPUS
treatment for stimulating bone regeneration has a long history. While there have at time been mixed
results in determining the specific effect a certain intensity of LIPUS has on cells or tissue, LIPUS has
routinely shown to improve bone regeneration. Small handheld LIPUS devices have been applied
clinically to stimulate healing in the scaphoid bone with good results. Likewise the application of LIPUS
has been shown to significantly improve the heal rate in non-unions which have persisted for over 5 years
following revision surgery. Adapting the current treatment process for fractures in such a way that LIPUS
can be applied more easily and more regularly may reduce the number and severity of healing defects.

Figure 1: LIPUS treatment of a fractured scaphoid bone through a hole in a plaster cast (Farkash et al.
2010. Journal of Orthopaedic Surgery and Research.)
The body generates bone in two ways: intramembranous bone formation (done directly by osteoblasts),
and endochondral ossification. In endochondral ossification bone is produced indirectly through the
calcification of cartilage and then the subsequent replacement of this cartilage with bone. This secondary
fracture healing has five phases: inflammation, angiogenesis, soft callus formation, hard callus formation,
and remodelling. Studies examining the effects of LIPUS on bone formation have shown that LIPUS
results in a rapid increase in callus area. Increased callus area has often been associated with an increase
in endochondral bone formation.
Assessments of how LIPUS
affects tissue at the cellular level
have shown LIPUS influences the
molecular behavior of cells in a
number of ways. LIPUS has been
shown to increase protein and
collagen
synthesis
in
mesenchymal
stem
cells,
fibroblasts, chondrocytes, and
osteoblasts. Other studies have
shown that LIPUS influences the
production of extracellular matrix
proteins and thus may influence
chondrocyte maturation and Figure 2: OSTEOTRON IV, Portable LIPUS device
endochondral bone formation. (http://www.itolator.co.jp/english/international/physiotherapy/osteotron4/index.html
Importantly, Work has shown )
that LIPUs does not stimulate

osteogenesis in intact bone, and thus does not has adverse effects on areas of bone surrounding the
wound.
Specific Aim 1: Create a comfortable and easy-to-use 3D printed plastic cast that completely
immobilizes the fractured bone while improving comfort and reducing the inconvenience of plaster
casts.
Rationale: Since every limb is different every 3D printed cast is unique. In order to manufacture a
perfectly fitted cast there is a need to scan the limb first. With todays technology 3D scanning is very
accessible, even modern videogames such as the Xbox Kinect (Microsofts motion sensor device) can be
adapted to create a CAD (Computer aided design) of the cast. After having the CAD, the cast can be
printed with a 3D printer. The design of the cast must restrain any movements of the limb, include several
openings for ventilation and sunlight and it must have a joint allowing it to be easily removed when
needed.
Experimental Approaches:
a) 3D Scan: Using a 3D scanner available at UVM it is possible to create the CAD model of the
limb. Nowadays its easy to get access to a 3D scanner, even modern videogames such as the
Kinect (Microsofts accessory to the Xbox) can be adapted and used as a scanner.
b) Create a model and 3D print it: After coming up with a comfortable, easy to attach and remove
model, it can be easily printed using high-speed 3D printers such as the MakerBot Replicator 2X.
c) Test the mechanical strength of the printed cast: After creating a cast that can be precisely fitted
to a limb the cast needs to be subjected to mechanical tests to insure that it is strong enough to
protect the broken bone.
Anticipated results, potential problems, future studies: As the geometry is not simple, it will probably
require several support structures to 3D print it without failure.
Specific Aim 2: Develop a device capable of low-intensity pulsed ultrasound which can interface
with our 3D printed plastic cast.
Rationale: Rather than developing a new LIPUS device, it is easier to use an already existing one, which
can save a large amount of time that can be spent testing its effectiveness instead of creating something
that has already been made. By using a commercial device future applications of the project are more
practical as well.
Experimental Approaches:
a) Adapt a commercially-available portable LIPUS device: Find a reliable LIPUS device and ensure
that it is capable of 0.5MHz-1.5MHz output. If the output of the device is too powerful then there
is the potential for adverse effects. Thus we must test to make sure the device is consistent and
outputting the right amount of energy.
b) Ensure that our 3D printed cast doesnt interfere with our ability to apply the LIPUS treatment to
the damaged bone: We will make sure that our 3D printed cast does not interfere with the LIPUS
treatment. To do this we will need to apply LIPUS to something before and after surrounding it in
our plastic cast and examine any potential differences in ultrasound beam profiles.
Anticipated results, potential problems, future studies: The reliability of the device will likely be
correlated with its price and there will be a need to find the balance between affordability and
effectiveness. The openings of the cast may direct the specific location of the LIPUS and make it difficult
to apply to the best possible region of the injury. Producing a cast with the injured site in mind may be
necessary to overcome this.
Specific Aim 3: Understand and optimize the best setup for LIPUS treatment in terms of, how long
should it be applied duration of application, what specific intensity, frequency, time of use and the
best pulse-ratio.
Rationale: A bone fracture goes through several stages before its completely healed. Right after the
fracture there is an inflammation around the region due to several blood vessels shattered, which creates a

mesh of fibroblasts. Approximately a week after the fracture Soft Callus is formed creating a site where
the new blood vessels, osteoblasts and periosteum can be multiplied and after about two weeks to a month
the soft callus is transformed into Woven Bone (Immature) which is the first bone contact between the
fracture. After the first month the Hard Callus is formed which is in fact the union between the two
broken parts. The human body usually creates more hard callus than is in fact needed, leaving the healed
bone enlarged compared to its original bone size.
The union is now formed and it goes through constant bone remodeling that may last for years after the
fracture since more bone is laid down where it is needed by Osteoblasts and removed by Osteoclasts,
depending on the stresses that are placed on the bone during every day and sports activities.
Experimental Approaches:
a) Quantify the difference between complete bone union with and without LIPUS: To completely
quantify how better the healing process is with this new method it is important to relate the time
needed to form each specific phase. By investigating how fast the formation of Soft callus, woven
bone, hard callus and bone remodeling is, it is possible to pinpoint at what time points the LIPUS
is most effective and when it is less useful.
b) Specify what is the best pulse-ratio, frequency, time of use and intensity for the LIPUS: Once the
effectiveness of the LIPUS is established there is a need to establish the best frequency, currently,
commercially-available LIPUS devices offers frequencies between 0.5MHz to 1.5MHz. The
typical pulse ratios are 1:1 and 1:4 meaning a pulse of 2m followed by a 2ms rest period and a
pulse of 2ms followed by an 8ms rest period, applied daily for 20 minutes respectively. The
intensity of the LIPUS is much lower than usual ultrasounds used in regular clinics, almost all of
the LIPUS research has used 0.03 W cm-2
Anticipated results, potential problems, future studies: During this point of the study there are suspicions
that the LIPUS only accelerates the formation of Hard Callus but that will only be safe to assume after
concrete data is acquired. Since there are many variables, it is going to be very hard to define the best
optimization of the LIPUS device. The best alternative is to work with the already used settings of
1.5Mhz, 1:1 pulse ratio applied daily for 20 minutes and change only one variable at a time such as the
time of use, intensity and frequency. This method will require several tests and a long time to be
completed since every test requires a period of one week to two months.
IV. SIGNIFICANCE: The main goal of this study is to develop a whole new method of healing bone
fractures and maybe an alternative method to heal non-unions rather than the complicated surgeries
currently required. Once all the variables are defined to ensure maximum efficiency to the LIPUS device
the total time to heal a broken bone can be significantly reduced, this can be especially useful to athletes
that want fractures to heal as soon as possible, or help people that have trouble using plaster casts which
cannot be wet and sometimes requires help to complete daily tasks such as taking a shower.

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