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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


I. INTRODUCTION
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
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
not be life threatening, they could significant effect one’s quality
of life. Therefore, minimizing time taken for healing such injuries health sector reports, diseases of the musculoskeletal system
is very important. Among several different methods available, low- and connective tissue stand among the top 10 leading causes of
intensity pulsed ultrasound (LIPUS) frequency of 1.5 MHz applied hospitalization[1]–[3]. When we consider about the people who
at an intensity of 30mW/cm2 has been found to accelerate bone don’t attend any medical facility for treatments , the total
healing, similarly varying frequency range of 0.75 MHz to 3 MHz number of patients should be higher than what is reported[2].
at an intensity of 0.5 W/cm2 to 3 W/cm2, have been reported to Millions of bone fractures occur worldwide annually[4], after
relieve pain and accelerate soft tissue healing. Even though LIPUS treatments 5% - 10% of those may end up as delayed healing or
has many benefits, it has not been widely used mainly because non-unions[4], thus improved treatment methods to enhance the
LIPUS machines are available only in hospitals and even the
fracture healing are important to make sure the speedy recovery
portable devices available in the market are large and less user
friendly. Therefore, in this study we aimed to develop a as well as to increase the quality of life of the patients.
LIPUS/ultrasound prototype which is portable, user-friendly, less
expensive and mobile-device compatible. This prototype was Methods of enhancing fracture repair can be categorized in to
developed as a mobile accessory with plug and play capability to two, physical stimulation therapies and biological therapies
harness the processing power of mobile devices and the increasing which can be further divided based on the method of
popularity of smart mobile devices among public. The device delivery[5]. Among several physical stimulation therapies,
contains a transducer which is powered by an input voltage signal Low-intensity pulsed ultrasound (LIPUS) is one of the latest
through an oscillator circuit of 3.5 MHz. It has been tested using a methods to accelerate fracture healing by using an ultrasound
phantom to check whether it operates in expected frequency and
frequency of 1.5 MHz with a pulse width of 200 µs and
intensity range. Results were compared with similar previous
studies. A mobile app was also developed using Android Studio to repetition frequency of 1 kHz, and an intensity of
operate the prototype. Therefore, in this study we have 30mW/cm2[4], [6]–[9]. LIPUS is a treatment procedure which
successfully shown that a mobile LIPUS/ultrasound prototype would be carried out for 20 minutes per day for several days
could be developed as a mobile accessory. However, this prototype depending on the fracture conditions[9], [10].
needs to be miniaturized, built into a probe similar to the replica
we designed and human trials carried out before the device is There are two main treatment methods used in orthopedics to
ready for public use. We believe that medical devices developed as treat muscular disorders, Pharmacological treatment which use
mobile accessories are more attractive to people and will also help medicine and drugs in order to achieve healing[11], and Non-
popularizing beneficial treatment procedures such as LIPUS pharmacological treatments[11]. In non-pharmacological
which could make people’s lives better. treatments, ultrasound treatment which is called as
Index Terms—Ultrasound, LIPUS, Oscillator, Bone fracture, “Therapeutic Ultrasound”, has become one of the most
Therapeutic 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 accommodate space for the newly formed bone.
and condition of injury[13]. Direct method, underwater bath to Simultaneously, osteoblasts replace the trabeculae bone with
treat small joints in degassed water and water bag method compact bone through endochondral ossification [4]..
which uses water bag as the coupling medium instead of gel.
There are two modes of the treatment which we use to treat B. Physiological background of soft-tissue healing
different conditions. Pulse mode is one of those two modes Soft tissue healing often refers to healing of stressed and
which is used to treat an injury in acute conditions where strained muscular tissues due to various reasons. Myofascial
thermal effect of ultrasound is not that important[14]. In pain or muscle pain is defined as pain that originates from
Continuous mode mainly focuses on thermal effect of myofascial trigger points in skeletal muscle[11]. It is prevalent
ultrasound to treat sub-acute and chronic stage injuries[12], in regional musculoskeletal pain syndromes, either alone or in
[13]. combination with other pain generators[19]. Myofascial pain
has a high prevalence among individuals with regional pain
As the use of smartphones is increasing rapidly all over the complaints[20]. The prevalence varies from 21% of patients
world and its’ ability to perform multiple functions, many have seen in a general orthopedic clinic, to 30% of general medical
paid their attention to use the power of smart phone hardware clinic [21].
to develop medical devices and accessories[15]–[17].
Therefore, designing a smart device enabled LIPUS probe for During the healing process of the muscle, it undergoes through
bone fracture and soft-tissue healing could also make three phases[22], [23]. Those can be known as destruction
ultrasound treatments more user friendly and widely used. 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
II. BONE FRACTURE AND SOFT TISSUE INJURY HEALING
tissue scar, as well as the capillary ingrowth into the injured
A. Physiological background of bone and fracture healing area[22], [23]. The last phase, the remodeling phase, is a period
The fracture healing process of a bone involves four steps: during which the maturation of the regenerated myofibers, the
inflammation, soft callus formation, hard callus formation, and contraction and reorganization of the scar tissue, and the
bone remodeling[4]. The inflammatory phase, also called recovery of the functional capacity of the muscle occur. And
fracture hematoma formation, is the first stage of healing that also repair and remodeling phases are closely associated or
occurs immediately after the injury [6]. According to Kaloty. R overlapping[23].
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
III. ULTRASOUND IN MEDICINE
to the bone, some bone cells around the fracture die[6]. This
inflammatory stage ends approximately one week after the Ultrasound is generally the sound, with the frequencies above
fracture. the audible range 20Hz – 20000Hz (20kHz). As it is a
mechanical energy, it requires a medium to travel. Ultrasound
Following inflammation is the genesis of a soft or fibro cannot propagate through vacuum like electromagnetic waves.
cartilaginous callus. Angiogenesis promotes the delivery of
osteogenic cells and fibroblasts to the site of injury, resulting in The frequency ranges of ultrasound, which is used in medical
the formation of an initial “procallus” [4]. The fibroblasts field is in 1MHz – 20MHz range. The frequency and the
secrete collagen to temporarily connect the broken ends of the intensity of the ultrasound wave is decided as to the requirement
bone, and the osteogenic cells differentiate in the avascular and the penetration power needed.
environment into chondroblasts. The chondroblasts
Most common use of the ultrasound in medical field is
subsequently deposit fibrocartilage, which converts the
diagnosing. Ultrasound scanning plays a major role in
procallus into the characteristic soft callus in the process of
diagnostic instrument which is vastly use in pregnancy imaging,
fracture healing [18].
body organ observations etc. Apart from imaging, lately
Fracture healing continues with the evolution of the soft callus experiments have shown that there are useful effects of
into a hard, bony callus. This process is initiated by the ultrasound in soft-tissue pain healing (Therapeutic ultrasound)
differentiation of osteogenic cells into osteoblasts in the well- and non-union bone fracture healing (LIPUS).
vascularized bone tissue. The osteoblasts initiate
intramembranous ossification, replacing the soft callus with a
trabeculae network of bone connecting the developing and A. Therapeutic Ultrasound
necrotic bone fragments[4].
Therapeutic ultrasound is a treatment which is commonly used
Bone remodeling is the final phase of fracture healing. in Orthopedic treatments. It is used in achieving pain relief, soft
Osteoclasts continue to remove necrotic bony tissue to
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tissue inflammation, soft tissue addition breakdown, tissue and can be downloaded from different internet stores and
repairing and phonophoresis. markets. A mobile device could readily communicate health
records, laboratory outcomes and radio-diagnostic
This treatment is applied in two modes Pulsed mode and interpretations, thus reducing waiting time and establishing an
Continuous mode which is decided by the physiotherapist as to environmentally friendly workplace by reducing the quantity of
the conditions of the injury, patient and the location of the paper used. Also, Mobile technology advancement creates fresh
injury. possibilities for improving health and streamlining
Pulsed mode is used for acute conditions, where it use intensity communication between physicians and patients. Mobile
varying from 0.8 W/cm2 to 3W/cm2 and frequency of 1MHz or medical applications (apps) can encourage wellness programs,
3MHz, which will be decided according to the depth of the remind patients to take drugs or plan appointments, and even
injury trigger point[24]. monitor vital factors[26].

In continuous mode, where it is used in subacute and chronic Medical apps are widely used by doctors and patients for
stage injuries, and uses intensities varying from 0.8 W/cm2 to 2 medical purposes. According to one survey study, most of the
W/cm2. Thermal effect plays a major role in this mode. apps that were requested were about medical books and
references, evidence-based medicine and up-to-date
Therapeutic ultra sound can be applied by using three methods, literature[27]. At present, the use of technical devices among
Direct method, Under water bath method and Water bag medical professionals’ ranges from 45% to 85%. Nearly three-
method. fourths of physicians said smartphones were needed to access
the internet during their job, and medical learners noted that
Although this treatment gives advantage of increasing smartphones were precious instructional resources[28].
permeability of cells, providing a micro massage and thermal Younger physicians tended to own a smartphone and use it to
effect, it cannot be applied on vascular conditions, radiotherapy interact with each other. In addition, mobile devices have often
sites, pregnancy and tumors etc. And also it has potential been used as a reference and information management tool
hazards like burns and cavitation. 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
B. LIPUS showed simple and quick access to suitable data. Further
LIPUS treatment is one of the recent advancements of using analyses of the use of applications and services would assist to
Ultrasound in medical applications. It has shown enhancement enhance this area and comprehend healthcare professionals'
requirements[29].
in fracture healing in number of studies.
As an example, the use of smart phones and smart apps in
This LIPUS treatment is a treatment procedure which may carry
out form 10 days to 60 days which rely on the condition of the Sonography/ Ultrasound technology to diagnose and analyse
fracture. diseases could be shown where, ultrasound imaging devices are
operated with the use of smart devices such as mobile phone
It is a 20minute treatment procedure which has to carryout and tabs because of their high processing power. This helps to
daily. LIPUS refers to a pulsed ultrasound which has 1MHz sine achieve fast transferring of data as well as the visuals to the
waves repeating at 1 kHz, average intensity 30mW/cm², pulse doctor if he is remotely located[17].
width 200 μs[4], [25].
It is therefore important to understand that currently, the
It does not focus on thermal effect of ultrasound, but mainly on healthcare industry is in a transition phase where many of the
mechanical effect. personal medical devices are replaced by sensors and
accessories developed for smart phones. With increasing
As similar to the therapeutic ultrasound treatment, LIPUS processing power and convenience, the rate of adoption of such
carries similar limitations and hazards. technologies are very high.
Therefore, in this study we aimed to design a smart device
enabled ultrasound probe for bone fracture and soft tissue
IV. USE OF SMART DEVICES AND SMART APPS IN HEALTHCARE healing.
INDUSTRY
Nowadays, many individuals have various portable smart V. METHODOLOGY
devices such as personal digital assistants (PDAs), A. Development of the smart-device application.
smartphones, wearable systems (e.g. intelligent watches,
glasses) and tablet PCs. Smartphones were effectively The GUI of smart-device app which is used to operate the
incorporated into the daily routine, in particular. Mobiles' are ultrasound probe was designed initially. In the designing
called smartphones with internet connection and computer-like process, the main concern was to make the app more user
characteristics. Software programs used in these smart devices friendly.
are called apps that have been developed for a specific function 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 Figure 2: Oscillator circuit to generate signal to power ultrasound
or decline for the warning messages, which were easy to probe
understand for the general user.
The bone interface was developed to only contain buttons for
It was tested on breadboard by using DC power supply and
Start, Stop and Back and a countdown timer was also included.
oscilloscope. The output signal was acquired from oscilloscope
The app was developed in such a way that a warning message
appears prior to the treatment informing the patient if he/her had and the observed output had the wave pattern which was
any heart or metal transplant or, if the patient was pregnant, expected, that had the frequency of 3.58MHz. The peak-to-peak
output voltage (Vpp) had shown a lesser value than expected. It
he/she should have medical advices. Similarly, this message
could only reach 1.6Vpp when the supplied input voltage was
appears before the treatment for muscle started.
9V. A value of 2.4Vpp could observe at 15V input voltage. In
Muscle interface was divided for two types of muscle aches, order to power the ultrasound transducer, it had to be above
‘Neck/Back’ and ‘Leg/Hand’. Both those interfaces were again 5Vpp.
divided as to the time from the injury occurred, less than two
days from the injury (< 2 days after injury) and more than two D. Data collection
days from injury (> 2 days after injury). 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
B. 3D rendered design of the probe the transducers function as intended. The temperature
increment of a bone inside a 3.3% agar block was carried out
The probe was designed using Solidwork software (Dassault
by Ohwatashi [30]. Data collection setup was prepared as
Systèmes, 2018 version). As it is shown in the Figure 1 below,
described by Ohwatashi [30] with minor modification to the
the 3D design of the probe was approximately 10 cm long and
protocol (Figure 3).
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 3: Data collection setup

The dimensions of the phantom which was used to collect data


Figure 1: Solidwork design of the probe 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
C. Development of the Circuit in a similar setup. Two clamps were used in order to keep the
The oscillator circuit was designed to generate the wave positions of transducer and thermometer unchanged during the
pattern which was required to power the ultrasound transducer. 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 treatment type and treatment time which would be helpful in
throughout the process. clinical environment and for patients who are having ultrasound
treatments for fracture healing and muscular disorders, in order
Since the power circuit of the device could not be completed, to check the patient’s treatment history.
actual data collection could not be carried out as yet. However,
once the data collection is completed those will be compared B. Development of the circuit
with the Ohwatashi’s work [30], where parameters are set at 1 The oscillator circuit which was mentioned in the methodology,
MHz and 3 MHz ultrasound with 2 W/cm2. Statistical analysis was tested on bread board initially with using the NPN
of data will be done and graphs will be generated using Graph transistor BC548. As it was a circuit which should has the
pad prism software. ability of generating 3MHz ultrasound, a crystal oscillator with
3.58MHz frequency was used.
VI. DISCUSSION
When the oscillator tested using DC power supply and
Throughout the process of developing the mobile phone app Oscilloscope, the observations supported that the circuit was
and ultrasound probe, there were several issues that had to be capable of providing the wave pattern which was required. It
overcome. The issues that were to sought out during the mobile was giving a similar wave pattern which was acquired using a
phone app development were mainly about making the GUI of similar device purchased online. But the peak-to-peak voltage
the app more user friendly and the safety features of it. Circuit of the output signal was very low. It was at 870mV – 920mV
development was more challenging procedure than it was in range when the given input was 5V, 1.2V – 1.3V at 9V input,
developing mobile app. Those were mainly about generating and 2.1V – 2.2V range was shown when the input was 15V.
the voltage signal which was required to operate ultrasound This was the major challenge which had to face throughout the
probe and about providing sufficient voltage to the probe in development of the circuit.
order to operate. To address those issues several options were
tested during the circuit development process. Those issues Initial step which was taken to overcome this obstacle was to
have been discussed under this section. change the resistor values and the capacitor values, and check
the output signal on the oscilloscope. But it could not provide
A. Development of mobile app any increase in output voltage. Then the next move was to try
During the process of mobile app development, the initially different transistors by replacing BC548. 2N3904 and 2N2222
designed app contained several interfaces which were to were the transistors used to replace BC548. With the use of
represent bone treatment, and muscle treatments. In that, those, it was evident that there was a little increment in the
muscle treatment was divided into two interfaces, as Pulsed and output voltage. When 5V input voltage was given, the output
Continuous. In those interfaces there were rotter knobs used, was at 940mV – 980mV range. It was at 1.4V – 1.6V range
which were required to adjust the intensity. In Android Studio when the input was 9V. Output peak-to-peak voltage of 2.3V –
mobile app developing software, there was no rotter knob 2.4V range could be observed when the input was 15V. But it
template. Therefore, it was required to import the rotter knob was not sufficient enough to power the ultrasound transducer.
template from other external library called Beppi Library. But with both 2N3904 and 2N2222, it was observed that they
generate a clear wave pattern at about 6.2V input. It was
It was decided that the initial design was too complex to operate decided to use 2N3904 as the replacement for BC548, as it gave
and not that user friendly. Therefore, it was adjusted, in order the highest output voltage increment.
to make it more user friendly. In that case the number of
interfaces were increased but the number of function buttons Next step taken was to try and use an operational amplifier
were limited to ‘Start’, ‘Stop’ and ‘Exit / Back’. circuit as a voltage amplifier, in order to amplify the voltage of
the output signal. LM741 op-amp was used in the process. But
It was important to add an indicator to inform the user about the the effort was not successful as the output signal of the
battery level of the probe. Therefore, a battery level indicator oscillator was 3.58MHz, and the op-amp couldn’t amplify a
was added to the mobile app, which was not mentioned in initial signal with that frequency.
GUI of the mobile app. And also as safety features, warning
messages which were to be appeared before the treatments were As the output voltage signal didn’t have the required peak-to-
started and ended were added. And the beeping alarm was set peak voltage, and also the op-amp circuit couldn’t amplify the
to indicate when the treatment was completed in order to inform output, a transistor voltage amplifier circuit was tested to see
any third party who is interested in the treatment procedure. whether the signal could amplify. 2N3904 was the transistor
This feature could be useful in clinical environment such as used in the amplifier circuit, which was the same used in
hospitals. And when the beeping alarm was added, it was oscillator circuit. After observing the output using oscilloscope,
considered about the patient’s comfort, as there might be some we couldn’t notice any amplification in output voltage. The
people who doesn’t want others to know about their medical output voltage had dropped further down and it was 440mV at
conditions. Therefore, the alarm which was added, was not loud 9V input. But we could observe a clear wave pattern at a low
or sound for longer period. input voltage such as 4.5V. All in all, the development of the
circuit to power the transducer was challenging as there were
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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