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1
Designing a smart device-enabled Ultrasound probe
for bone fracture and soft tissue healing.
#
Abeysuriya, U.H., Karunarathna, S.D., Premadasa, K.M.G.P.
Department of Electrical Electronic and Telecommunication Engineering
General Sir John Kotelawala Defence University
# uvinduab@gmail.com

Abstract— Muscle pains, soft tissue inflations and bone
fractures can be considered as some of the most common injuries
one could face in their day-to-day life. Though such injuries may
not be life threatening, they could significant effect one’s quality
of life. Therefore, minimizing time taken for healing such injuries
is very important. Among several different methods available, lowintensity pulsed ultrasound (LIPUS) frequency of 1.5 MHz applied
at an intensity of 30mW/cm2 has been found to accelerate bone
healing, similarly varying frequency range of 0.75 MHz to 3 MHz
at an intensity of 0.5 W/cm2 to 3 W/cm2, have been reported to
relieve pain and accelerate soft tissue healing. Even though LIPUS
has many benefits, it has not been widely used mainly because
LIPUS machines are available only in hospitals and even the
portable devices available in the market are large and less user
friendly. Therefore, in this study we aimed to develop a
LIPUS/ultrasound prototype which is portable, user-friendly, less
expensive and mobile-device compatible. This prototype was
developed as a mobile accessory with plug and play capability to
harness the processing power of mobile devices and the increasing
popularity of smart mobile devices among public. The device
contains a transducer which is powered by an input voltage signal
through an oscillator circuit of 3.5 MHz. It has been tested using a
phantom to check whether it operates in expected frequency and
intensity range. Results were compared with similar previous
studies. A mobile app was also developed using Android Studio to
operate the prototype. Therefore, in this study we have
successfully shown that a mobile LIPUS/ultrasound prototype
could be developed as a mobile accessory. However, this prototype
needs to be miniaturized, built into a probe similar to the replica
we designed and human trials carried out before the device is
ready for public use. We believe that medical devices developed as
mobile accessories are more attractive to people and will also help
popularizing beneficial treatment procedures such as LIPUS
which could make people’s lives better.
Index Terms—Ultrasound, LIPUS, Oscillator, Bone fracture,
Therapeutic
I. INTRODUCTION
M
uscle pains, soft tissue inflations and bone fractures can
be considered as some of the most common injuries that
one could face in their day-to-day life. According to
health sector reports, diseases of the musculoskeletal system
and connective tissue stand among the top 10 leading causes of
hospitalization[1]–[3]. When we consider about the people who
don’t attend any medical facility for treatments , the total
number of patients should be higher than what is reported[2].
Millions of bone fractures occur worldwide annually[4], after
treatments 5% - 10% of those may end up as delayed healing or
non-unions[4], thus improved treatment methods to enhance the
fracture healing are important to make sure the speedy recovery
as well as to increase the quality of life of the patients.
Methods of enhancing fracture repair can be categorized in to
two, physical stimulation therapies and biological therapies
which can be further divided based on the method of
delivery[5]. Among several physical stimulation therapies,
Low-intensity pulsed ultrasound (LIPUS) is one of the latest
methods to accelerate fracture healing by using an ultrasound
frequency of 1.5 MHz with a pulse width of 200 µs and
repetition frequency of 1 kHz, and an intensity of
30mW/cm2[4], [6]–[9]. LIPUS is a treatment procedure which
would be carried out for 20 minutes per day for several days
depending on the fracture conditions[9], [10].
There are two main treatment methods used in orthopedics to
treat muscular disorders, Pharmacological treatment which use
medicine and drugs in order to achieve healing[11], and Nonpharmacological treatments[11]. In non-pharmacological
treatments, ultrasound treatment which is called as
“Therapeutic Ultrasound”, has become one of the most
commonly used treatments for wide variety of soft tissue
injuries[11]–[13]. With a varying frequency range of 0.75 MHz
to 3 MHz and intensity varying between 0.5 W/cm2 to 3 W/cm2,
inducible acoustic vibrations are delivered to the site.
Therapeutic ultrasound achieve deeper penetration with lower
frequencies[14]. Therapeutic Ultrasound is performed in three
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different methods which differ according to the treatment site
and condition of injury[13]. Direct method, underwater bath to
treat small joints in degassed water and water bag method
which uses water bag as the coupling medium instead of gel.
There are two modes of the treatment which we use to treat
different conditions. Pulse mode is one of those two modes
which is used to treat an injury in acute conditions where
thermal effect of ultrasound is not that important[14]. In
Continuous mode mainly focuses on thermal effect of
ultrasound to treat sub-acute and chronic stage injuries[12],
[13].
As the use of smartphones is increasing rapidly all over the
world and its’ ability to perform multiple functions, many have
paid their attention to use the power of smart phone hardware
to develop medical devices and accessories[15]–[17].
Therefore, designing a smart device enabled LIPUS probe for
bone fracture and soft-tissue healing could also make
ultrasound treatments more user friendly and widely used.
II. BONE FRACTURE AND SOFT TISSUE INJURY HEALING
A. Physiological background of bone and fracture healing
The fracture healing process of a bone involves four steps:
inflammation, soft callus formation, hard callus formation, and
bone remodeling[4]. The inflammatory phase, also called
fracture hematoma formation, is the first stage of healing that
occurs immediately after the injury [6]. According to Kaloty. R
et al, approximately 48 hours after the injury, blood vessels torn
by the fracture release blood. This blood starts to clot and forms
a fracture hematoma. Because of the disruption of blood flow
to the bone, some bone cells around the fracture die[6]. This
inflammatory stage ends approximately one week after the
fracture.
Following inflammation is the genesis of a soft or fibro
cartilaginous callus. Angiogenesis promotes the delivery of
osteogenic cells and fibroblasts to the site of injury, resulting in
the formation of an initial “procallus” [4]. The fibroblasts
secrete collagen to temporarily connect the broken ends of the
bone, and the osteogenic cells differentiate in the avascular
environment into chondroblasts. The chondroblasts
subsequently deposit fibrocartilage, which converts the
procallus into the characteristic soft callus in the process of
fracture healing [18].
Fracture healing continues with the evolution of the soft callus
into a hard, bony callus. This process is initiated by the
differentiation of osteogenic cells into osteoblasts in the wellvascularized bone tissue. The osteoblasts initiate
intramembranous ossification, replacing the soft callus with a
trabeculae network of bone connecting the developing and
necrotic bone fragments[4].
Bone remodeling is the final phase of fracture healing.
Osteoclasts continue to remove necrotic bony tissue to
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accommodate space for the newly formed bone.
Simultaneously, osteoblasts replace the trabeculae bone with
compact bone through endochondral ossification [4]..
B. Physiological background of soft-tissue healing
Soft tissue healing often refers to healing of stressed and
strained muscular tissues due to various reasons. Myofascial
pain or muscle pain is defined as pain that originates from
myofascial trigger points in skeletal muscle[11]. It is prevalent
in regional musculoskeletal pain syndromes, either alone or in
combination with other pain generators[19]. Myofascial pain
has a high prevalence among individuals with regional pain
complaints[20]. The prevalence varies from 21% of patients
seen in a general orthopedic clinic, to 30% of general medical
clinic [21].
During the healing process of the muscle, it undergoes through
three phases[22], [23]. Those can be known as destruction
phase, repair phase and remodeling phase. Destruction phase
is characterized by the rupture of the myofibers, the formation
of a hematoma between the ruptured muscle stumps, and the
inflammatory cell reactions[22]. The repair phase, is consisting
of the phagocytosis of the necrotized tissue, the regeneration of
the myofibers, and the concomitant production of a connective
tissue scar, as well as the capillary ingrowth into the injured
area[22], [23]. The last phase, the remodeling phase, is a period
during which the maturation of the regenerated myofibers, the
contraction and reorganization of the scar tissue, and the
recovery of the functional capacity of the muscle occur. And
also repair and remodeling phases are closely associated or
overlapping[23].
III. ULTRASOUND IN MEDICINE
Ultrasound is generally the sound, with the frequencies above
the audible range 20Hz – 20000Hz (20kHz). As it is a
mechanical energy, it requires a medium to travel. Ultrasound
cannot propagate through vacuum like electromagnetic waves.
The frequency ranges of ultrasound, which is used in medical
field is in 1MHz – 20MHz range. The frequency and the
intensity of the ultrasound wave is decided as to the requirement
and the penetration power needed.
Most common use of the ultrasound in medical field is
diagnosing. Ultrasound scanning plays a major role in
diagnostic instrument which is vastly use in pregnancy imaging,
body organ observations etc. Apart from imaging, lately
experiments have shown that there are useful effects of
ultrasound in soft-tissue pain healing (Therapeutic ultrasound)
and non-union bone fracture healing (LIPUS).
A. Therapeutic Ultrasound
Therapeutic ultrasound is a treatment which is commonly used
in Orthopedic treatments. It is used in achieving pain relief, soft
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tissue inflammation, soft tissue addition breakdown, tissue
repairing and phonophoresis.
This treatment is applied in two modes Pulsed mode and
Continuous mode which is decided by the physiotherapist as to
the conditions of the injury, patient and the location of the
injury.
Pulsed mode is used for acute conditions, where it use intensity
varying from 0.8 W/cm2 to 3W/cm2 and frequency of 1MHz or
3MHz, which will be decided according to the depth of the
injury trigger point[24].
In continuous mode, where it is used in subacute and chronic
stage injuries, and uses intensities varying from 0.8 W/cm2 to 2
W/cm2. Thermal effect plays a major role in this mode.
Therapeutic ultra sound can be applied by using three methods,
Direct method, Under water bath method and Water bag
method.
Although this treatment gives advantage of increasing
permeability of cells, providing a micro massage and thermal
effect, it cannot be applied on vascular conditions, radiotherapy
sites, pregnancy and tumors etc. And also it has potential
hazards like burns and cavitation.
B. LIPUS
LIPUS treatment is one of the recent advancements of using
Ultrasound in medical applications. It has shown enhancement
in fracture healing in number of studies.
This LIPUS treatment is a treatment procedure which may carry
out form 10 days to 60 days which rely on the condition of the
fracture.
It is a 20minute treatment procedure which has to carryout
daily. LIPUS refers to a pulsed ultrasound which has 1MHz sine
waves repeating at 1 kHz, average intensity 30mW/cm², pulse
width 200 μs[4], [25].
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and can be downloaded from different internet stores and
markets. A mobile device could readily communicate health
records,
laboratory
outcomes
and
radio-diagnostic
interpretations, thus reducing waiting time and establishing an
environmentally friendly workplace by reducing the quantity of
paper used. Also, Mobile technology advancement creates fresh
possibilities for improving health and streamlining
communication between physicians and patients. Mobile
medical applications (apps) can encourage wellness programs,
remind patients to take drugs or plan appointments, and even
monitor vital factors[26].
Medical apps are widely used by doctors and patients for
medical purposes. According to one survey study, most of the
apps that were requested were about medical books and
references, evidence-based medicine and up-to-date
literature[27]. At present, the use of technical devices among
medical professionals’ ranges from 45% to 85%. Nearly threefourths of physicians said smartphones were needed to access
the internet during their job, and medical learners noted that
smartphones were precious instructional resources[28].
Younger physicians tended to own a smartphone and use it to
interact with each other. In addition, mobile devices have often
been used as a reference and information management tool
among junior experts[27]. Mobile phones play a major role in
spreading innovative instruments such as medical applications
(apps). Using smartphones in an internal medicine clinic
showed simple and quick access to suitable data. Further
analyses of the use of applications and services would assist to
enhance this area and comprehend healthcare professionals'
requirements[29].
As an example, the use of smart phones and smart apps in
Sonography/ Ultrasound technology to diagnose and analyse
diseases could be shown where, ultrasound imaging devices are
operated with the use of smart devices such as mobile phone
and tabs because of their high processing power. This helps to
achieve fast transferring of data as well as the visuals to the
doctor if he is remotely located[17].
As similar to the therapeutic ultrasound treatment, LIPUS
carries similar limitations and hazards.
It is therefore important to understand that currently, the
healthcare industry is in a transition phase where many of the
personal medical devices are replaced by sensors and
accessories developed for smart phones. With increasing
processing power and convenience, the rate of adoption of such
technologies are very high.
IV. USE OF SMART DEVICES AND SMART APPS IN HEALTHCARE
Therefore, in this study we aimed to design a smart device
enabled ultrasound probe for bone fracture and soft tissue
healing.
It does not focus on thermal effect of ultrasound, but mainly on
mechanical effect.
INDUSTRY
Nowadays, many individuals have various portable smart
devices such as personal digital assistants (PDAs),
smartphones, wearable systems (e.g. intelligent watches,
glasses) and tablet PCs. Smartphones were effectively
incorporated into the daily routine, in particular. Mobiles' are
called smartphones with internet connection and computer-like
characteristics. Software programs used in these smart devices
are called apps that have been developed for a specific function
V. METHODOLOGY
A. Development of the smart-device application.
The GUI of smart-device app which is used to operate the
ultrasound probe was designed initially. In the designing
process, the main concern was to make the app more user
friendly.
Android Studio was selected as the mobile application
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developer software. Mobile app was developed using high level
language Java, which is vastly used in similar projects to
develop medical purposed mobile phone applications[16].
User friendly interface with appropriate instructions at every
level was an important feature to guide the user without any
complications. In it, there were different interfaces in order to
start the treatment, where simple knowledge about the injury
was enough to select the appropriate treatment procedure.
Therefore, the mobile app was developed with few selection
buttons such as injury type, place of the injury, time after the
injury occurred, to start and stop the treatment and to proceed
or decline for the warning messages, which were easy to
understand for the general user.
The bone interface was developed to only contain buttons for
Start, Stop and Back and a countdown timer was also included.
The app was developed in such a way that a warning message
appears prior to the treatment informing the patient if he/her had
any heart or metal transplant or, if the patient was pregnant,
he/she should have medical advices. Similarly, this message
appears before the treatment for muscle started.
Muscle interface was divided for two types of muscle aches,
‘Neck/Back’ and ‘Leg/Hand’. Both those interfaces were again
divided as to the time from the injury occurred, less than two
days from the injury (< 2 days after injury) and more than two
days from injury (> 2 days after injury).
B. 3D rendered design of the probe
The probe was designed using Solidwork software (Dassault
Systèmes, 2018 version). As it is shown in the Figure 1 below,
the 3D design of the probe was approximately 10 cm long and
maximum 4 cm wide. The probe head had a diameter of 3 cm.
The probe contained a USB female port in order to connect with
the mobile phone. And also there was a LED indicator which
was to indicate when the connection with the mobile phone was
completed.
Figure 2: Oscillator circuit to generate signal to power ultrasound
probe
It was tested on breadboard by using DC power supply and
oscilloscope. The output signal was acquired from oscilloscope
and the observed output had the wave pattern which was
expected, that had the frequency of 3.58MHz. The peak-to-peak
output voltage (Vpp) had shown a lesser value than expected. It
could only reach 1.6Vpp when the supplied input voltage was
9V. A value of 2.4Vpp could observe at 15V input voltage. In
order to power the ultrasound transducer, it had to be above
5Vpp.
D. Data collection
In order to validate the device’s intensity, an appropriate setup
was designed to collect data. Increase in temperature for a given
duration by a given intensity was investigated to check whether
the transducers function as intended. The temperature
increment of a bone inside a 3.3% agar block was carried out
by Ohwatashi [30]. Data collection setup was prepared as
described by Ohwatashi [30] with minor modification to the
protocol (Figure 3).
Figure 3: Data collection setup
Figure 1: Solidwork design of the probe
C. Development of the Circuit
The oscillator circuit was designed to generate the wave
pattern which was required to power the ultrasound transducer.
The dimensions of the phantom which was used to collect data
was 4cm×4cm×3cm. It was decided to put the bone at 2cm from
the bottom of the phantom and to keep a hole to access near the
bone surface from the side. IR thermometer was selected to
measure temperature as it is capable of giving accurate readings
in a similar setup. Two clamps were used in order to keep the
positions of transducer and thermometer unchanged during the
process. The temperature of the bone surface was required to
measure in every 40 seconds for 10 minutes. It was also
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important to keep the heights marked as H1 and H2 unchanged
throughout the process.
Since the power circuit of the device could not be completed,
actual data collection could not be carried out as yet. However,
once the data collection is completed those will be compared
with the Ohwatashi’s work [30], where parameters are set at 1
MHz and 3 MHz ultrasound with 2 W/cm2. Statistical analysis
of data will be done and graphs will be generated using Graph
pad prism software.
VI. DISCUSSION
Throughout the process of developing the mobile phone app
and ultrasound probe, there were several issues that had to be
overcome. The issues that were to sought out during the mobile
phone app development were mainly about making the GUI of
the app more user friendly and the safety features of it. Circuit
development was more challenging procedure than it was in
developing mobile app. Those were mainly about generating
the voltage signal which was required to operate ultrasound
probe and about providing sufficient voltage to the probe in
order to operate. To address those issues several options were
tested during the circuit development process. Those issues
have been discussed under this section.
A. Development of mobile app
During the process of mobile app development, the initially
designed app contained several interfaces which were to
represent bone treatment, and muscle treatments. In that,
muscle treatment was divided into two interfaces, as Pulsed and
Continuous. In those interfaces there were rotter knobs used,
which were required to adjust the intensity. In Android Studio
mobile app developing software, there was no rotter knob
template. Therefore, it was required to import the rotter knob
template from other external library called Beppi Library.
It was decided that the initial design was too complex to operate
and not that user friendly. Therefore, it was adjusted, in order
to make it more user friendly. In that case the number of
interfaces were increased but the number of function buttons
were limited to ‘Start’, ‘Stop’ and ‘Exit / Back’.
It was important to add an indicator to inform the user about the
battery level of the probe. Therefore, a battery level indicator
was added to the mobile app, which was not mentioned in initial
GUI of the mobile app. And also as safety features, warning
messages which were to be appeared before the treatments were
started and ended were added. And the beeping alarm was set
to indicate when the treatment was completed in order to inform
any third party who is interested in the treatment procedure.
This feature could be useful in clinical environment such as
hospitals. And when the beeping alarm was added, it was
considered about the patient’s comfort, as there might be some
people who doesn’t want others to know about their medical
conditions. Therefore, the alarm which was added, was not loud
or sound for longer period.
In the future, it is better the mobile app to have a data base,
which carries the treatment data including, patient name,
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treatment type and treatment time which would be helpful in
clinical environment and for patients who are having ultrasound
treatments for fracture healing and muscular disorders, in order
to check the patient’s treatment history.
B. Development of the circuit
The oscillator circuit which was mentioned in the methodology,
was tested on bread board initially with using the NPN
transistor BC548. As it was a circuit which should has the
ability of generating 3MHz ultrasound, a crystal oscillator with
3.58MHz frequency was used.
When the oscillator tested using DC power supply and
Oscilloscope, the observations supported that the circuit was
capable of providing the wave pattern which was required. It
was giving a similar wave pattern which was acquired using a
similar device purchased online. But the peak-to-peak voltage
of the output signal was very low. It was at 870mV – 920mV
range when the given input was 5V, 1.2V – 1.3V at 9V input,
and 2.1V – 2.2V range was shown when the input was 15V.
This was the major challenge which had to face throughout the
development of the circuit.
Initial step which was taken to overcome this obstacle was to
change the resistor values and the capacitor values, and check
the output signal on the oscilloscope. But it could not provide
any increase in output voltage. Then the next move was to try
different transistors by replacing BC548. 2N3904 and 2N2222
were the transistors used to replace BC548. With the use of
those, it was evident that there was a little increment in the
output voltage. When 5V input voltage was given, the output
was at 940mV – 980mV range. It was at 1.4V – 1.6V range
when the input was 9V. Output peak-to-peak voltage of 2.3V –
2.4V range could be observed when the input was 15V. But it
was not sufficient enough to power the ultrasound transducer.
But with both 2N3904 and 2N2222, it was observed that they
generate a clear wave pattern at about 6.2V input. It was
decided to use 2N3904 as the replacement for BC548, as it gave
the highest output voltage increment.
Next step taken was to try and use an operational amplifier
circuit as a voltage amplifier, in order to amplify the voltage of
the output signal. LM741 op-amp was used in the process. But
the effort was not successful as the output signal of the
oscillator was 3.58MHz, and the op-amp couldn’t amplify a
signal with that frequency.
As the output voltage signal didn’t have the required peak-topeak voltage, and also the op-amp circuit couldn’t amplify the
output, a transistor voltage amplifier circuit was tested to see
whether the signal could amplify. 2N3904 was the transistor
used in the amplifier circuit, which was the same used in
oscillator circuit. After observing the output using oscilloscope,
we couldn’t notice any amplification in output voltage. The
output voltage had dropped further down and it was 440mV at
9V input. But we could observe a clear wave pattern at a low
input voltage such as 4.5V. All in all, the development of the
circuit to power the transducer was challenging as there were
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no specifications available for the ultrasound transducer used in
the probe
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VII. CONCLUSION
The aim of this research was to design a smart deviceenabled ultrasound probe for bone fracture and soft tissue
healing. During the process, the mobile phone app was
completed with the required features including simple GUI. In
the circuit development, since several parameters needed to be
tested regarding ultrasound transducer, it took longer time than
expected. The transducer was not excited either with voltage
amplifications or current amplifications as it was expected.
Therefore, all aspects of the circuit design could not be
completed. However, provided that more time is available, the
power amplification component of the circuit could be
developed by calculating the impedance of the transducer in
order to amplify the current and the voltage simultaneously and
compete the oscillator circuit. Similarly, at the completion of
the circuit design, data collection, comparison and the
standardization could also be carried out. This was only an
attempt to develop a mobile compatible LIPUS/ultrasound
prototype. We however designed a replica of a final device
which could be made by miniaturizing the prototype. Therefore,
in a future study, the miniaturizing and human trials should be
carried out before the mobile LIPUS/ultrasound device is ready
for public use.
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