Development of Retention System of the Autonomous Endoscopic

Capsule and Its Functionalities

Dmitry Mikhaylov

, Timur Khabibullin

, Igor Zhukov

, Andrey Starikovskiy

Landish Gubaydulina

, Natalya Romanchuk

and Vladimir Konev

Engineering Centre of the National Research Nuclear University “MEPhI”,

Kashirskoye highway 31, 115409, Moscow, Russian Federation

The Clinical Hospital № 85, Moskvorechie street 16, 115409, Moscow, Russian Federation

Keywords: Electroactive Polymer, Endoscopic Capsule Retention System, Expandable Capsule, Angular Orientation,

Cancer, Fluorescent Beacon.

Abstract: The aim of the research is to propose the retention system of the wireless endoscopic capsule allowing more

detailed observation of stomach, small intestine as well as other parts of the digestive tract. The capsule has

an outer layer or whiskers made of an electroactive polymer material that expands under influence of an

applied voltage. An electroactive polymer expands up to 50% of its original size and creates a roughly ball-

shaped object approximately 3 cm in diameter (in case of whiskers – they change their angular orientation).

The performance (changing the size) of the mock-up of the capsule with eight whiskers made of

electroactive polymer was tested using a silicone model with sensitive sensors simulating the digestive tract

of a person. The probability of failure-free operation and the mean time to failure for capsule and recording

device integrated circuits were calculated.

1 INTRODUCTION

Capsule endoscopy is a way to record images of the

digestive tract for use in medical examination and

diagnosis. The patient swallows the capsule which

goes down the digestive tract as ordinary food and

the capsule takes images. They can be obtained at

any point of the stomach or the gastrointestinal tract.

The images are sent to a recording device that the

patient can carry or be close to during the procedure.

The primary use of endoscopic capsule is to

examine areas of the small intestine that cannot be

seen by other types of endoscopy, such as

colonoscopy or esophagogastroduodenoscopy

(EGD).

This type of examination is often done to find

sources of bleeding or abdominal pain. The

procedure was approved by the Food and Drug

Administration of the United States in 2001

(Scherbakov P.L., 2010). Upper endoscopy, EGD

uses a camera attached to a long flexible tube to

view the esophagus, the stomach and the beginning

of the first part of the small intestine called the

duodenum.

A colonoscope, once inserted through the

rectum, can view the colon and the distal portion of

the small intestine, the terminal ileum.

Unfortunately, these two types of endoscopy cannot

visualize the majority of the middle portion of the

gastrointestinal tract, the small intestine. (R. de

Francis, 2012)

Therefore, capsule endoscopy is useful when

disease is suspected in the small intestine and can

diagnose sources of occult bleeding (blood visible

microscopically only) or causes of abdominal pain,

such as Crohn's disease or peptic ulcers (Lecheng

Yu, 2012; Jebarani, W.S.L, 2013; Dongmei Chen,

2011).

Once swallowed, the capsule needs to be

controlled in order to acquire images of the entire

area.

There are two problems that gastroenterologists

face while conducting examination. In the stomach

capsule is relatively fast directed by peristalsis that

does not allow to examine certain parts or areas of

interest. In other parts of the digestive tract the

situation is reverse. In the intestine the peristalsis

may be poor (this is true especially for people with

Mikhaylov D., Khabibullin T., Zhukov I., Starikovskiy A., Gubaydulina L., Romanchuk N. and Konev V..

Development of Retention System of the Autonomous Endoscopic Capsule and Its Functionalities.

DOI: 10.5220/0004719400770084

In Proceedings of the International Conference on Biomedical Electronics and Devices (BIODEVICES-2014), pages 77-84

ISBN: 978-989-758-013-0

 2014 SCITEPRESS (Science and Technology Publications, Lda.)

gastrointestinal pathologies and diseases) whereby

the capsule may get stuck until it is taken out by the

food. Moreover, because of its small size the capsule

can be subject to a greater rotation in the small

intestine, which could potentially cause missing of

pathologies. (R. de Francis, 2012)

Resently many studies have been carried out to

solve the problem of capsule control (Kim Y.T.,

2010; Woo S.H., 2011; Park H.J., 2005; Zuo J,

2005; Chiba A, 2005; Sungwook Yang, 2011;

Wenwen Chen, 2013). They show good results and

present original ideas; however, the possible

disadvantages of these proposals may be large

capsule power consumption limiting the examination

time, necessity in additional sophisticated

equipment, etc.

Consider conventional capsules that may be

controlled by forces of the magnetic field. For

example, such a capsule is described in DE

102006019986 (Johannes Dr. Reinschke, 2007). The

disclosed endoscopy capsule for use in patient's

gastrointestinal tract has a magnetic element

enabling rotating, swivelling and tilting of the

capsule as well as an adjustable power supply unit

for providing electrical voltage used for creation of

the magnetic field.

However, magnetic field and additional electrical

circuitry increases the cost and possibly size of the

capsule. The system requires external devices that

generate magnetic fields (magnetic materials,

electromagnets). Furthermore, efficiency of the

system can be affected by a secondary magnetic

field that interacts with the metal parts of the

capsule. Essentially, the secondary magnetic field

with the intensity of the controlling field is sufficient

for disruption of capsule’s functionality.

Moreover, because of the anatomical features of

the small intestine, its tortuosity, the control system

based on the magnetic field dors not always allow

precise manipulation with capsule location.

Accordingly, there is a need in the art for an

efficient and effective endoscopic capsule that is

autonomous and can be retained in the stomach and

other parts of the gastrointestinal tract for a long

periods of time and provide easier passage through

intestine if needed.

For this end this paper deals with the new

proposal to provide endoscopic capsule with the

ability of retention enabling more detailed

examination of the digestive tract.

2 EXPANDING ENDOSCOPIC

CAPSULE

The proposed capsule endoscopy system provides an

efficient and safe way to observe a patient’s stomach

and intestinal tract. The capsule remains in the

desired part of the digestive tract acquiring images

and recording them to an external device. The

gastroenterologist can review the images and make a

diagnosis at his convenience.

The capsule does not require a special insertion

system and can be simply swallowed. The expansion

takes place in a standalone mode in response to an

outside command.

The endoscopic capsule can expand not only

inside the stomach, but in any part of the

gastrointestinal tract, for example, in the large

bowel. This enables the capsule to stimulate

peristalsis in order to accelerate its passage through

the intestinal canal.

2.1 Capsule Components

The miniature capsule consists of a light sensitive

matrix, a radio frequency transceiver, a backlighting

device and a battery.

Figure 1: Block-diagram of the wireless endoscopic

capsule.

Figure 1 illustrates an endoscopic capsule. The

capsule includes

an electroactive polymer material that

BIODEVICES2014-InternationalConferenceonBiomedicalElectronicsandDevices

increases its volume inside the patient’s stomach or

intestine upon receiving a control radio signal from

an external device.

The endoscopic capsule can be, for example, 24

mm in length and about 10 mm in diameter. It

includes a microcontroller, which controls a light

sensitive matrix with optics (i.e., a miniature

camera). For example, CMOS matrix with resolution

of 640 by 480 pixels can be used. The optics can be

a plurality of lenses.

The endoscopic capsule includes a LED panel

for providing lighting for the light sensitive matrix

for taking images.

The microcontroller controls the light sensitive

matrix and the LED panel in order to synchronize

the light flashes with the image taking (the duty

cycle of the LED illumination can be 6.6%, or two

flashes per second, 1/30 of a second each).

A built-in camera takes two images per second,

which are then compressed and transmitted

according to medical regulations. Since battery life

and transmission speed are limited, a typical

transmission is 240 x 240 pixels per image, with 8

bit colour, which is often insufficient for medical

purposes.

To improve image resolution and reduce power

consumption some data analysis can be performed

locally (i.e., in the capsule), to avoid transmitting

images that have not changed from previous ones.

Also, images that are very similar to previous ones

(even if not identical) also might not be transmitted

depending on degree of similarity (e.g., 90% similar

or 95% similar, etc.). Images that are too dark to

contain much information also might not be

transmitted.

The compression and analysis can be performed

locally by the microcontroller and/or by a custom or

semi-custom integrated circuit, permitting

transmission of, e.g., 320 x 320 or even 480 x 480

pixels, with 16 bit colour.

In order for the images to provide more

diagnosis-related information, the capsule uses a

variety of colour lighting provided by colour high

emitting diodes that turn on each time a picture is

taken. For example, red light helps in detecting

micro bleedings and blue light is beneficial for

detecting structural abnormalities.

The light emitting diodes panel includes white,

red, yellow and blue diodes. The colour diodes

advantageously replace conventional flash lights

(with colour filters) that use a lot of battery charge.

The images are taken using white red, blue and

yellow illuminations in this order. However, a larger

number of the diodes can be used (for example, 8,

12, etc.). The blue lighting allows for better images

of the blood vessels, the red lighting assists in

detection of bleedings, and yellow lighting assists in

adenoma detection.

The diodes are paired by two of the same colour.

This provides for even light distribution.

Alternatively, multi-colour diodes can be used.

Additionally, special mirrors can be used in

combination with the diodes for a more even light

distribution.

The diode panel is located perpendicular to a

vertical (longitudinal) axis of the capsule, with the

diodes facing upwards. The light sensitive matrix

can be implemented in the centre of the diode panel.

The capsule is covered by a phosphorescent layer

for additional lighting. Thus, the pictures taken by

the endoscopic capsule are, advantageously, more

accurate for diagnosis making.

Figure 2 illustrates phosphorescent coating of the

endoscopic capsule. The capsule is covered by the

phosphorescent coating (Fig. 2a). In order to project more

light forward, the cover of the capsule is implemented in a

corrugated shape as shown in Fig. 2b. The corrugation of

the cover is implemented in a lateral plane. If the

phosphorescent coating is used in combination with light

emitting diodes, the frequency of light emission of the

diodes and the phosphorescent coating needs to be

synchronized. Phosphorescent coating of the capsule

should not be affected by the electroactive polymer.

Figure 2: Phosphorescent coating.

The microcontroller is connected to a radio

transceiver having an antenna. For example, a

transceiver made by ZARLINK can be used. This

transceiver uses standard frequency of 403-405 mHz

with a power of 25 mW (Mikhaylov D.M., 2013).

The antenna can be integrated into the body of

the capsule for better reception/transmission

characteristics. The radio transceiver provides

signals to the microcontroller for activation of the

electromagnetic cover and expanding the capsule.

DevelopmentofRetentionSystemoftheAutonomousEndoscopicCapsuleandItsFunctionalities

The capsule is wirelessly connected to a portable

recording device that receives images and records

them to an integrated memory for review by a

gastroenterologist.

A battery powers the circuits within the capsule.

The battery can be, for example, shaped as a round

tablet with a diameter of 4-8 mm and a height of 9

mm (or 5-10 mm, generally).

After examination is completed, the

microcontroller receives a signal through the radio

transceiver for reducing the voltage and deactivating

the electroactive polymer outer layer of the capsule.

Subsequently, the capsule (i.e., the electroactive

polymer layer) shrinks back to an original size, goes

down the intestinal tract and leaves the body in a

natural way.

The recorder with the images is then provided to

the gastroenterologist, who analyses the images at a

workstation using medical image processing

applications.

2.2 Capsule Retention System

In quite a number of cases specialists need long-term

visual observation. Such long-term observation may

be easily implemented if capsule endoscopy is

applied using the capsule. The endoscopic capsule

has a possibility of its retention in the stomach for

more detailed study. It is especially important, for

example, when the cancer of the stomach is

suspected or diagnosed.

The system of the capsule retention in the

stomach consists of the following components:

1. A balloon module that includes the following

elements:

 a cover made of an elastomeric dispersive

material, such as dimethylpolysiloxane;

 a valve made of a sheet dimethyl-polysiloxane

(Med 2174) with a silicone adhesive (Med

4213);

 a silicone cover applied by dipping (Med 6607);

 a silicone elastomer (Med 4850) and tantalum (in

order to make the valve impenetrable to

irradiation).

2. The cover for a balloon module made of the

following exemplary materials to facilitate the

allocation and intubation of the device:

 dimethyl-polysiloxane dispersion;

 bicarbonate of soda to ease the installation of the

balloon into the cover and to prevent the

intermolecular cross-linkage during storage.

3. A block of the conductor material made of the

following materials and components:

 stainless steel 304, covered with

polytetrafluoroethylene;

 polypropylene box-coupling of Lyuer;

 an adhesive (Loctite 3201).

4. A filling tube made of the following

components and materials:

 the tubes made of a silicone elastomer (Q7-4780)

by extrusion;

 a tip of the filling tube made of polypropylene;

 a box-coupling of Lyuer made of polypropylene.

As one option, the balloon can be made of

polyvinyl chloride (PVC), and inflated from a built-

in remotely triggered compressed air storage. As a

further option, the balloon can be inflated through a

catheter-like thread that extends through the

oesophagus when the capsule is in the stomach.

In addition the balloon can be made of an

electroactive polymer shaped like a ring (torus)

around the capsule that “unfolds” to a much larger

diameter through a change in angular orientation.

The cover is fixed to the capsule in such a way that

the opaque part is located inside the transparent

balloon.

The outer surface of the capsule is made of an

electroactive polymer material that increases its

volume under influence of a voltage, like a balloon,

or changes its angular orientation.

An electroactive polymer that covers the capsule

expands to 30-50% of its original size and creates a

roughly ball-shaped object approximately 3 cm in

diameter (Fig. 3). This size is sufficient for retention

in the stomach that normally has a passage of

approximately 2-2.5 cm in diameter into the

digestive tract.

Figure 3: Expanded capsule (ball-shaped).

Electroactive polymer materials are widely used

today as artificial muscles in robotics (Henry

Sheppard, 2007) and manufactured by several

companies, for example, Environmental Robots Inc.

(Environmental Robots Inc., 2014).

The capsule is retained in the patient’s stomach

and can be used for a prolonged generation of

images of various areas. This can be especially

useful for observation of influences of new

BIODEVICES2014-InternationalConferenceonBiomedicalElectronicsandDevices

medications (for example, stomach cancer

medications).

The voltage is provided by the battery located

within the capsule. The battery charge of the capsule

can last for about 12 hours. As an option, in case

when a longer observation is required, the battery

can be charged wirelessly via magnetic coupled

coils, one inside the capsule and the other (or others)

outside patient’s body, so the capsule in its expanded

(inflated) state can remain in the stomach or in other

part of a gastrointestinal tract for indefinitely long

period of time (Fig. 4).

Figure 4: Capsule battery charged by magnetic field.

The capsule, as needed, can be controlled by a

magnetic field as it has a magnetic element. The

capsule has a magnetic element in a form of a

neodymium tablet about 5 (e.g., about 4-7) mm in

diameter and about 2 (e.g., about 1.5-2.5) mm in

height.

Another unique feature of the capsule is a set of

extendable whiskers that extend from the surface of

the capsule cover. This can be used as an alternative

to the balloon described above, or, as a further

alternative, the whiskers can be inside the balloon

(for example, made of PVC, and used to “inflate”

the balloon).

Figure 5 illustrates expandable whiskers made of

an electroactive polymer implemented on the

endoscopic capsule. An electroactive polymer is

triggered by an electric signal. The whiskers are

positioned along a surface of the capsule (see Fig.

5a) for convenient swallowing by a patient. Once the

capsule is swallowed, a radio signal is received and

created voltage of the opposite sign is applied at the

point of voltage application; the whiskers extend out

(changing their angular orientation) and control

movement of the capsule (see Fig. 5b and Fig.6), so

Figure 5: Expandable whiskers.

the moving stream of food does not take the capsule

down the intestinal tract.

Whiskers

Capsule body

Whi s ker s

Poi nts of

voltage

application

Figure 6: Expanded capsule.

The expanded capsule`s size L=d+2h≈3.5 cm (see

Fig. 5a and Fig. 6).

Diameter of the small intestine does not exceed

3-5 cm and about 2.5-3 cm in ileum (Small intestine,

2009). It means that the proposed capsule can stop at

any part of ileum and in some areas of jejunum as

well as stay in the stomach for a long period of time

(as the pylorus does not exceed 2-2.5 cm in

diameter). At the same time the expanded

endoscopic capsule can initiate peristalsis in case the

capsule gets stuck in the intestine in order to

continue the examination (R. de Francis, 2012).

The wireless endoscopic capsule uses eight

extendable whiskers for movement control.

However, an arbitrary number of whiskers can be

used depending on desired retention of the capsule.

Once all required images are taken, another radio

signal is sent to the capsule and the voltage is

terminated. Subsequently, the whiskers fold back to

the original position depicted in Fig. 5a.

DevelopmentofRetentionSystemoftheAutonomousEndoscopicCapsuleandItsFunctionalities

2.3 Experiments

While working on the development of the proposed

wireless endoscopic capsule`s retention system the

mock-up of the capsule with eight whiskers made of

electroactive polymer has been created. In the initial

state the capsule has the size of an ordinary pill –

13x29 mm; in the expanded state its size increases to

35x29 mm (as shown in Fig. 6).

The performance of the capsule was tested using

a silicone model with sensitive sensors simulating

the digestive tract of the person. The capsule was

forced to change its size under influence of applied

voltage (Fig. 7).

Figure 7: Experiment scheme.

50 out of 50 attempts have showed desired results.

These experiments showed that it takes on the

average 3 seconds for capsule to expand and 5

seconds to take its original shape.

2.4 Reliability Expectations

The proposed wireless endoscopic capsule

comprises three integrated circuits (light sensitive

matrix, controller and transceiver) responsible for

the execution of its functions. The circuits can be

regarded as series-connected elements in the scheme

of reliability calculation.

Mean time to failure of integrated circuits of

average degree of integration is estimated at 300 000

hours without the presence of ionizing radiation and

strong electromagnetic fields that do not occur under

normal conditions in urban and rural areas.

The probability of failure-free operation is

0.99999000003 and the mean time to failure is 100

000 hours or 11.4 years.

The capsule recording device contains 31 (field

programmable logic device, microcontroller,

memory, and 14 sensors including microcontroller

and the transceiver) microcircuits responsible for the

execution of its functions. The microcircuits can be

regarded as series-connected elements in the scheme

of reliability calculation.

The probability of failure-free operation is

0.999897 and the mean time to failure is 9 678 hours

or 1.1 years.

2.5 Capsule Options

Images acquired by the capsule can be processed

using known in the industry methods. A

gastroenterologist can review images in a real time

and make a rapid diagnosis by reviewing a colour

and a texture anomalies and pathologies of the form

that correspond to a visual manifestation of the

disease (Alexander Kukushkin, 2012; Kukushkin

Alexander, 2013; Bourbakis, N., 2005). After the

capsule remains inside a patient a certain amount of

time, a three-dimensional image of the areas passed

by the capsule can be generated and reviewed.

As a further clinical application, the

electropolymer of the capsule can be used for

dilatation of narrowed areas of the digestive tract

(for example, due to scarring, infection,

inflammation, and similar processes).

The capsule can be used to deliver a drug or

active compound from a reservoir (Fig. 8), which is

covered by a lid, formed of a memory metal, such as

Nitinol.

Figure 8: Drug delivery.

When heated to body temperature inside the

BIODEVICES2014-InternationalConferenceonBiomedicalElectronicsandDevices

patient’s stomach, the lid opens (returns to its

original shape), permitting the active compound to

egress.

As a further option, the capsule can be provided

with:

 a system for generating the trajectory that the

capsule followed, such as by using a gyroscope

and/or an accelerometer inside the capsule. The

data from these sensors is sent to the external

reader, together with the image data. This makes

it easier to determine the location of the

particular images taken by the capsule, making it

easier to know where the particular problems are

(and exactly where surgical intervention might

be needed);

 a heating element, which is activated by an

operator when the capsule is near a location

where coagulation of blood leaking from cuts or

wounds is occurring;

 two cameras, one for the “forward” direction,

and one for the “backward” direction, which may

be particularly useful for inspecting the intestine;

 additional sensors, such as a pH sensor

(Stepanyan D.А., 2011), to determine acidity;

 a magnetic coil, which can be used to increase

the resolution of magnetic resonance imaging.

The coil can be located anywhere in the capsule,

and can have arbitrary orientation.

The capsule of the present invention may be used

for early diagnosis of various oncological diseases,

particularly gastrointestinal cancers. For this

purpose, fluorescent agents/beacons can be used.

These beacons, which interact with cancerous cells,

due to their chemistry, begin fluorescing at a

wavelength in the visible, infrared and/or ultraviolet

portions of the spectrum. This fluorescence permits

diagnosing oncological diseases at an early stage

(which typically does not have noticeable

symptoms), without the use of a biopsy.

If the only purpose is to detect the existence of a

cancerous tumour, there is no need to transmit video

or image frames to a computer in real time. The

processor on the capsule can, by itself, identify those

frames that show fluorescence, based on the average

brightness of the image, and transmit only those

frames. This significantly lowers the time needed for

analysis of the gastrointestinal tract using the

capsule. For example, instead of 2-3 hours, the

diagnosis can be made within 5-10 minutes, if

oncological-related fluorescent activity is detected.

Also, there is no need for additional illumination

sources in the capsule itself. This permits increasing

the length of time of battery operation, since no

energy needs to be used for illuminating the

gastrointestinal tract.

3 CONCLUSIONS

This paper has been demonstrated the idea of

creating a retention system of the wireless

endoscopic capsule using the property of

electroactive polymer to increase the size and

change angular orientation under applied voltage.

This ability of capsule to change the shape will

allow gastroenterologists to carry out more detailed

examination of patient`s digestive tract getting

additional images of suspected areas.

The studies on further capsule construction,

reliability and functionality improvements are

underway. Although the proposed capsule has

shown good results on the silicone model it is

planned to be subjected to further field and lab

studies and tests as well as clinical trials.

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BIODEVICES2014-InternationalConferenceonBiomedicalElectronicsandDevices