Smart Inhaler Systems

PROJECT REPORT

Submitted in partial fulfilment of the requirements of the course

INSTR F432

By

BOTLAGUDURU SATVIK                      2017A8PS0421P

Submitted to

Dr. Sujan Yenuganti

Associate Professor, Department of Electrical & Electronics Engineering

Birla Institute of Technology and Science, Pilani

Pilani Campus

June 2020

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 Acknowledgement
First and foremost, I would like to thank my professor for this project, Dr Sujan Yenuganti
for his valuable guidance and advice regarding the project.

Besides, I would like to thank the authority of BITS Pilani, Pilani Campus for providing a
good environment and facilities to complete this project.

Finally, an honourable mention goes to my family and friends for their understanding and
support in completing this project. Without the help of those mentioned above, I would have
faced many difficulties while doing this.

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Table Of Contents
Acknowledgement 2

Table of Contents 3

Abstract 4

Introduction 5

Notable diseases requiring usage of Inhalers 6

Asthma 6

COPD 6

Types of Traditional Inhalers 7

MDIs 7

Dry Powder Inhalers 8

Nebulizers 8

Soft Mist Inhalers 9

Efficient Drug Release 10

The Smart Inhaler System 11

SIS in the Market 12

CareTRx 12

Smart Nebulizers 13

MyAirCoach smart inhaler 13

The Clip Tone Device 14

Challenges 15

Conclusion 15

References 16

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Abstract
Asthma and COPD are two of the biggest non communicable chronic diseases by the number
of people affected each year. Both the diseases don’t have any cure, but can be managed
using various types of inhaler medications. Traditional inhalers may be effective, but without
the current inhaler technique, and proper analysis of the same, it is not the most efficient.
With Smart Inhaler Systems coming into focus in recent years in this field, inhalers are being
equipped with newer technologies that can help analyse and improve the condition of the
patient. This report discusses all the above points, along with various such devices in the
market that are helping make the life of an asthmatic or COPD-affected patient better.

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Introduction
In the present day, the inhalation of therapeutic aerosols has become standard procedure for
the treatment of a variety of respiratory diseases especially for asthma and COPD (chronic
obstructive pulmonary disease), which affect nearly 300 million people worldwide. Affected
areas within the lungs can be treated in a direct and fast-acting way through Aerosol
inhalation. With medicine for pain management and systemic therapy also being administered
through the nose and mouth.

Inhalers are medical devices used to deliver medicines into the lungs of the patients through
the work of a person’s breathing. Through this, medicines are delivered and absorbed into the
lungs, which allows targeted medical treatments to certain parts of the lungs. It also helps in
the reduction of the side effects of various oral medications.

Fig 1. An Inhaler (Ekern, B. E. B., Ekern, B., & Ekern Enterprises. (2020, May 18))

For ailments in which the medicine is relatively non-aggressive, delivery via traditional
inhalers is more than suitable. Asthma is one such ailment. But for more aggressive
medications, which may also be more toxic, the method of delivery is an important factor to
be kept in mind.

The pressurized metered dose inhaler (pMDI) is a traditional device that is used in aerosol
drug delivery. It dispenses the uniform air-particle mixture into the mouth inlet. However, a
large amount of the medicine is deposited in the upper oral airway, because of the turbulent
mixing and impaction of the particles. This deposition, especially in the airway constriction
near the larynx, greatly reduces the efficiency of the method.

With the ability to link to an app on the phone help the doctor and patient manage asthma
better, and sensors which can detect areas of high pollution etc. inhalers are becoming
smarter by the day. Efficient drug release mechanisms to increase the efficiency of such
devices has also been researched on, and subsequently, newer and better models of “smart”
inhalers are coming up in this market.

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Notable diseases which require the usage of Inhalers
Two of the major diseases that affect human beings and hence require inhalers for treatment
are Asthma and COPD.

Asthma

Fig 2: Asthma, inside walls of airways in lungs get swollen and inflamed. (Asthma. (2020,
June 4))

It is a chronic inflammatory disease of the airways to the lungs, that makes breathing
difficult, and subsequently many physical activities challenging. During an asthma attack, the
lining of the bronchial tubes swell up, airways narrow, and flow of air going into and out of
lungs gets reduced.
With more than 300 million people affected per year in the world, it is one of the most
commonly faced non communicable diseases. The severity ranges from being really mild,
making it a little difficult to handle daily activities, to life threatening attacks. Major
symptoms include difficulty in breathing, chest pain, cough and wheezing.
Two types of Inhalers are usually used to manage asthma, one to treat it (rescue inhalers-
salbutamol) and the other to prevent symptoms (controller inhalers- steroids).
More severe cases may require long term inhalers, to keep the airways open(formoterol,
salmeterol, tiotropium), and other inhalant steroids.

COPD

Chronic obstructive pulmonary disease is a disease that makes it difficult for persons to
breathe normally. It is usually prevalent in cigarette smokers. More than 65 million people in
the world have this disease, and based on the previous trends, this number will increase in the

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near future. Major symptoms include cough, wheezing, weight loss, chest tightness and
chronic dyspnea.

Fig 3: COPD, symptoms and major forms (Phelan, L. (2018, November 16))

It has two main forms:

1. Chronic Bronchitis- Involves long term cough with mucus constriction and inflammation
taking place in the airways to the lungs
2. Emphysema- involves lung damage over time, and degradation of the alveolar membrane

Most people with COPD have a combination of both of the above conditions.

Medicines for the same are administered through rescue inhalers and inhaled or oral steroids.
These help manage the condition, for it has no proper cure.
For severe cases or during flare-ups, bronchodilators through a nebulizer are administered.

Types of traditional Inhalers

Currently, MDIs, nebulizers, dry powder inhalers and soft mist inhalers are available in the
traditional inhaler market. Each inhaler and its functionality has to be understood first to
make the necessary adjustments required to turn it into a smart inhaler for best results.
A combination of the above inhalers is used to treat certain diseases.

MDI (Meter Dosed Inhaler)

The Meter Dosed Inhaler is important for the treatment of chronic diseases, mainly asthma
and COPD. It consists of a pressurized cylinder of medicine in a plastic case with a
mouthpiece. Other than this, a holding chamber exists to hold the MDI in place, with a
mouthpiece, and a valve for mist delivery control.

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Fig 4: (Left)Structure of an MDI (Metered Dose Inhaler. (2019, July 15)), (Right) a common
MDI

Dry Powder Inhalers

Dry powder inhalers, like MDIs, are also important in the treatment of asthma and COPD.
This device consists of a plastic cylinder to inhale powdered medication. These are breath
activated, and the device automatically releases medication when you breath into it.

Fig 5: A common dry powder Inhaler (dry-powder-inhaler. (2016, March 1))

Nebulizers

A variety of medicines for various chronic diseases are available in a nebulized form. This
delivery system consists of a nebulizer, which is like a small plastic bowl with top screw,
along with a source for compressed air. The source changes the medication solution into
breathable mist/vapour.

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 Fig 6: A nebulizer (Dr. Morepen CN06 Compressor Nebulizer. (n.d.))

Soft Mist Inhalers

This is a comparatively newer type of inhaler that provides a pre-measured amount of

medicine in a mist that is slow-moving. This mist helps in the inhalation of the medicine.
Putting the lips on the nozzle while holding the device horizontally helps in the maximum
impact of the medicine.

Fig 7: A soft mist inhaler (Dalby R, Spallek M, Voshaar T)

Each one of the above inhalers has a different technique for administering the medication.
Improper use of the devices can lead to the distribution of the medicine in the mouth or
throat, where it cannot take its desired effect. With this issue in mind, the research for Smart
Inhalers took place, to get an inhaler, that helps the patient administer the medicine correctly,
for its maximum effect.

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Efficient Drug Release
In 2003, Kleinstreuer and Zhang, found that the most efficient way of drug release into the
airway is the controlled release of an air-particle stream. Instead of letting it mix with the
inhalation airflow upstream of the patient’s mouth, the drugs are released at a specific
position at the mouth opening. Various simluations have shown that this increases the number
of drug particles travelling through the airway, without any loss due to deposition. The
simulations also showed that the final deposition location in the lungs could be controlled by
releasing the stream at a specific inlet. Hence, this could help physicians to target specific
sites in the lung for treatment.

Fig 8: Normal drug distribution (Matthew E. Pausley, Stefan Seelecke)

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 Fig 9: Controlled drug delivery using air particle stream methodology (Matthew E. Pausley,
Stefan Seelecke)

As seen in Figure 8, when the drug is distributed normally, letting it mix with the inhalation
airstream of the patient, the efficiency greatly reduces due to distribution of the drug in areas
that do not require to be treated, and hence only a small amount of drug reaches the actual
tumor area.

Shown above in Figure 9, is the controlled distribution of drug as proposed by Kleinstreuer

and Zhang. We can observe that the drug is distributed only at the targeted site, hence
ensuring maximum efficiency.

Their research also showed that the final particle deposition position could be correlated to
the initial inlet particle stream release position in the mouth. As shown above, this
theoretically could be very useful for physicians to target specific locations in the lung for
treatment of say, a tumour, using inhalers.

The Smart Inhaler System

With the above considerations in mind, in Paulsey and Seelecke (2008) developed an SIS,
which was multifunctional Shape Memory Alloy-based.

The SIS replaced the fixed nozzle type of inhalers with an adjustable nozzle that could be
moved in any desired location. The data from numerical modelling, combined with the
patient’s morphology, provided the patient specific release information. The flexible nozzle
then allowed the SIS to adapt to the different patient specific needs for precise delivery of the
drug.

This allowed the drug to be delivered to specific lung locations, as per the prototype created.

By employing SMA actuators though, this added a dependency for electricity. Still, the model
itself showed that with a proper feedback system, and a better understanding of SMA in the
context of the device could lead to even better models being developed in the future for
targeted drug release.

In the recent past, a lot of Smart Inhaler Systems have been developed, focusing on other
important considerations such as Inhalation technique, better analysis of the patient’s health,
the patient’s physical condition during inhalation, the frequency of usage of the inhaler etc.

Using Bluetooth technology to detect the patient use, reminding patients when to take
medication and collecting data to help guide care, are some of the newer features of this
upcoming development in the field of medicine. Air pollution and smoking, two of the major
contibutors to more and more asthma cases, as well as a rise in the COPD cases, has led to a
rise in the usage of the SIS.

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 Fig 10: Prototype created by Paulsey and Seelecke (2008)

Adding accelerometers, differential pressure sensors, and temperature sensors to get other
realtime data now helps doctors keep track of their patient’s health and usage habits, doctors
now can figure out what is triggering a specific attack quickly.
Some of the products currently available in the market are discussed in the next section.

SIS in the market

Following are some of the popular smart inhaler systems in the market right now, with each
one of them focusing on a number of different issues, tackled with the use of technology.

CareTRx

The system was launched in 2014. It looked like a small cap equipped with sensors and a
memory on board that notes the data whenever the user presses on the inhaler to deliver a
medication dose. The cap fits over most metered-dose inhalers. In close proximity to the
user’s mobile device, it automatically connects and syncs all the data to the cloud, and to the
app on the phone respectively. Whenever it is time for a dose, the lights illuminate around the
cap. The app also offers other features such as a diary that tracks any miss of a dose, potential
triggers and peak flows.

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 Fig 11: The CareTRx system with the android app showing 75 percent adherence ((71),
rabeel et.al)

Smart Nebulizers

Smart Nebulizers employ AAD (adaptive Aerosol delivery) technology, which analyses the
patient’s breathing pattern in order to find out the timing of the aerosol drug release during
inhalation. It first analyses the first three breaths for any pressure changes. This helps in
determining the correct timing for the delivery. It then continues to analyse the preceding 3
breaths throughout the treatment to adapt to the patient’s breathing pattern. By adapting to the
breathing pattern, the nebulizer is able to vary the drug delivery and reduce the loss of
aerosol. With a feedback system to alert the patient, a buzzer sets off as soon as the preset
dose is delivered to the patient. With AAD systems such as I-neb, all the above can be
achieved easily.

MyAirCoach smart inhaler

The MyAirCoach inhaler is an initiative that has combined an asthma inhaler with a range of
sensors and mobile technology promises to change this. This device, along with storing the
patient’s physiological information, also stores information about the surrounding
environment, such as humidity and temperature.

It even collects information on how the patient is using the device, such as shaking the
inhaler, before pressing a button to get the medicine dose.

All this information, can then be fed back to the patient’s and/ or the doctor’s smartphones or
computer in realtime, to help better know and manage the symptoms faced.

Previously the”smart” inhalers only had a GPS, for location updates, but now multiple
sensors are placed for the better analysis. These include a microphone and accelerometer for
the recording of the patient’s inhaling technique, GPS for the location, and other
biomonitoring sensors for measurement of humidity, temperature etc.

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 Fig 12: MyAirCoach Inhaler (Info. (n.d.))

The device can successfully communicate with the patient’s phone and smartwatch through a
simple app. A vitual assistant of sorts helps the patient access the data on the phone and
offers advice on hoe to improve their techniques and successfully manage the disease. The
software, also allows the doctors to send auto and manual notifications, based on their
realtime health, reminding them to take medications at a certain limit etc.

The information collected could also prove vital in helping the medical community gain a
better understanding of asthma and other respiratory issues, what cause them and why they
seem to be getting more common.

The Clip-Tone device

The clip-tone device is a technique guidance device that was launched by Clement Clarke in
2019. It transforms ordinary inhalers into smart inhalers without the need for costly
electronics or bulky add-ons. It is an attachment which clips to the top of an inhaler and
produces a whistling sound when the inhaler is used. The attachment works with an app on
the person’s smartphone, which uses SoundResponse technology to analyse the sound signal
and provide feedback to the patient in real-time on their inhalation technique. It also helps
keep a track of the audience and sending regular medication reminders. The Sound Response

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technology, developed by University of Manchester spin-out Clin-e-cal, only requires access
to the smartphone’s microphone when in use.

Fig 13: An inhaler, and a clip tone device to be attached (Home. (n.d.))

With the current COVID-19 outbreak, and reduced contact with healthcare professionals, this
solution could help patients manage long-term respiratory conditions.

Challenges
Limited awareness about the usage of the smart inhalers is one of the major factors inhibiting
its extensive usage. The difficulties in the correct adapting of the inhaler technique, leads to
insufficient medication. This further leads to poor disease control along with increased
healthcare costs. Error in coordination between inhalation and drug release creates decreased
efficacy through reduced deposition of drug in the lungs, eventually leading to an increase in
the rate of disease severity. Hence, people are preferring the traditional inhalers for easier
operation. With not a lot of pharmacists familiar with the newer forms of this technology, and
the monitoring responsibility that they will now have, it is less preferred by them.

Conclusion
The smart inhaler system, with all its benefits and features, can help improve patients’
observance to asthma treatments and keep their condition under control, but it is clear that the
system has to be designed with health systems and patients in mind to get the maximum
benefit out of the same. Training and a proper understanding of this new area of medicine
will be needed. This is an area that pharmacists will have to own and become acquainted
with, soon.

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