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Transcript of 2013 A miniature fiber optic blood pressure sensor and its application in in-vivo blood pressure...
Sensors and Actuators B 181 (2013) 172– 178
Contents lists available at SciVerse ScienceDirect
Sensors and Actuators B: Chemical
journa l h o me pa ge: www.elsev ier .com/ locate /snb
A miniature fiber optic blood pressure sensor and its application in in vivo blood
pressure measurements of a swine model
Nan Wua, Ye Tiana, Xiaotian Zoub, Yao Zhaib, Kurt Barringhausc, Xingwei Wanga,∗
a Electrical and Computer Engineering Department, University of Massachusetts Lowell, 1 University Ave., Lowell, MA 01854, USAb Biomedical Engineering and Biotechnology Department, University of Massachusetts Lowell, 1 University Ave., Lowell, MA 01854, USAc University of Massachusetts Memorial Medical Center, University of Massachusetts Medical School, 55 Lake Ave., North Worcester, MA 01655, USA
a r t i c l e i n f o
Article history:Received 17 September 2012
Accepted 3 February 2013
Available online 17 February 2013
Keywords:Blood pressure
Optical fiber
Pressure sensor
Fractional flow reserve
a b s t r a c t
Fractional flow reserve (FFR) is a promising technique in diagnosis of coronary artery stenosis. The
technique is applied in coronary catheterization to measure the blood pressure (BP) difference across
a coronary artery stenosis in the blood flow. In vivo BP measurement is the key element in FFR diagnosis.
This paper describes the utilizing of a novel miniature fiber optic sensor to measure the BP of a swine
model in vivo. A 25–50 kg Yorkshire swine model was used as the test target. A guiding catheter was
introduced into the coronary artery, and blood pressure signals in aortic arch and right coronary artery
were measured by the fiber optic sensor. A standard invasive manometry was used as the reference.
Finally, a 2.25 mm balloon was inflated in the catheter to simulate the stenosis and the BP drop was
recorded by the fiber optic sensor. The experiment demonstrates that the reported fiber optic sensor has
the capability of measuring blood pressure in vivo and can be used for FFR technique.
© 2013 Elsevier B.V. All rights reserved.
1. Introduction
Coronary artery disease (CAD), which is caused by the accumu-
lation of atheromatous plaques within the walls of the coronary
arteries that supply the oxygen and nutrients to the myocardium
[1], is the leading cause of the death. Most CAD patients are not
aware of the disease for decades as the disease progressing until
the first symptoms, often an acute heart attack, finally show up.
The disease is the most common cause of sudden death [2] as well
as the most common reason for the death of people over 20 years
old [3]. Moreover, half of healthy 40-year-old males will probably
develop CAD in the future, and one in three healthy 40-year-old
women [3].
Percutaneous coronary intervention (PCI) is a common ther-
apy directed toward alleviating CAD. It is important to assess the
severity of the lesion and its impact on blood flow before, during
and after the angioplasty procedure. Assisted by this information,
cardiologists can determine whether a PCI is necessary. Tradition-
ally, angiography is the standard method to assess the severity
of the lesion but is of limited value when lesions of intermediate
severity are identified, because it cannot provide adequate infor-
mation regarding whether the blood flow can be impacted by such
an intermediate lesion. In order to determine the lesion’s impact
on blood flow, additional information is required. By interrogating
∗ Corresponding author.
E-mail address: xingwei [email protected] (X. Wang).
the frequency shift between the sound wave emanated from the
source and that reflected from the moving blood cells, a Doppler
ultrasound guidewire can be used to measure the blood flow rate
[4]. However, technical limitations have prevented this technol-
ogy from becoming clinically useful. Another method, hot-wire
anemometry, uses thermistors to monitor a tiny thermal gradient
in a fluid flow stream [5]. However, this method may damage blood
cells or tissues because of the heat.
Fractional flow reserve (FFR) is an alternative method to
evaluate the stenosis in coronary artery [6–12]. The severity of
the narrowing is determined by measuring the blood pressure
difference across a coronary artery stenosis in the blood flow
through coronary catheterization. This method has been eventually
accepted by doctors since 1990s. In order to achieve accurate FFR
diagnosis, in vivo blood pressure measurement is critical. Various
studies have been conducted on how FFR benefits to the diagno-
sis of the coronary artery stenosis by conducting the intravascular
blood pressure measurement [12]. Most of the sensors used in these
studies are electrical sensors which may generate electrical noises
to interfere with other electrical equipments in the operating room,
where the electromagnetic interference is risky to patients. On the
other hand, fiber optic pressure sensor is a potential substitution
to the current electrical pressure sensors. The fiber optic pressure
sensor can be easily packaged in a guide wire due to its compact
size which is generally 125 �m in diameter. Due to its all optical
operating principle, the fiber optic sensor cannot interfere with
other electrical equipments. Samba Sensors released a fiber optic
pressure sensor for intravascular blood pressure measurement. The
0925-4005/$ – see front matter © 2013 Elsevier B.V. All rights reserved.http://dx.doi.org/10.1016/j.snb.2013.02.002
N. Wu et al. / Sensors and Actuators B 181 (2013) 172– 178 173
sensor is made by attaching a 0.36–0.42 mm diameter silicon sen-
sor head to the tip of a 0.25 mm diameter optical fiber [13]. The
bulky head of the sensor prevents it from further reducing the size.
This paper presents a fiber optic blood pressure sensor with uni-
form diameter of 125 �m for the purpose of in vivo blood pressure
measurement. The sensor was tested in a swine model at University
of Massachusetts Medical School in Worchester, MA. The stenosis of
the coronary artery was simulated by inflating a 2.25 mm balloon in
the catheter. A reference manometer was placed side by side with
the fiber optic sensor for the comparison purpose. In order to com-
pensate the bending loss introduced by the big curvature of aortic
arch, a special interrogation system was designed. Experimental
results demonstrated that the fiber optic sensor has the capability of
monitoring the blood pressure profile and the blood pressure drop
caused by the inflated balloon. Moreover, the reported fiber optic
blood pressure sensor proves its capability of being utilized in FFR
applications to determine the location of stenosis in the coronary
artery.
2. Fiber optic blood pressure sensor
2.1. Design and principle
The fiber optic pressure sensor is designed based on Fabry–Perot
(FP) interferometer [14–18], as shown in Fig. 1. Three elements can
be observed: a single-mode fiber, a multi-mode fiber, and a sil-
icon dioxide (SiO2) diaphragm. The multi-mode fiber is applied
to fabricate an air cavity which is formed by wet etching using
hydrofluoric acid (HF). The diameter of the cavity is determined
by the diameter of the multi-mode fiber core and the depth of the
cavity is determined by the etching duration. The SiO2 diaphragm
is attached by the end of the air cavity by thermal bonding tech-
nique. Therefore, the multi-mode fiber core/air cavity interface and
the air cavity/diaphragm interface form an FP cavity on which the
reflection lights will generate an interference pattern. The single-
mode fiber guides the interrogation light exciting on the FP cavity
and collects the reflected lights.
According to the principle of the FP interferometer, the optical
phase � of the interference pattern is governed by
� = 4�Ln
�0, (1)
where L is the length of the FP cavity; n is the refractive index of
the cavity, which is 1 (air) in this case; �0 is the wavelength of the
interrogation light. The optical phase changes when the length of
the FP cavity changes due to an external pressure applying on the
diaphragm. The relationship between the FP cavity length changes
and the external pressure can be expressed by [19]:
Yc = 3(1 − v2)Pr4
16Eh3, (2)
where Yc is the center deformation of the diaphragm; v is the
diaphragm’s Poisson’s ratio; P is the external pressure applied to
the diaphragm; r is the radius of the diaphragm; h is the thickness
of the diaphragm; E is the Young’s modulus of the diaphragm.
The external pressure can be determined by interrogating the
optical phase changes. In a low finesse FP cavity case, which is
Single-mode fiber Multi-mode fiber
Fiber core Air cavity
SiO2 diaphragm
Fig. 1. The schematic structure diagram of the fiber optic blood pressure sensor.
Fig. 2. Microscopic photograph of a fabricated BP sensor. (a) Sideview and (b) end-
face.
caused by the low reflectivity of each reflection interface, the
reflected optical intensity can be approximated by a sinusoidal
function [20]:
I = I0[1 + V cos(� − �0)], (3)
where I0 is the mean optical intensity; V is the visibility of the FP
interferometer; �0 is the initial optical phase. Therefore, the pres-
sure applied to the diaphragm can be determined by interrogating
the reflected optical intensity.
2.2. Fabrication
The fabrication method was published elsewhere [14]. Briefly,
the silicon dioxide diaphragm was released by back etching sili-
con away the silicon substrate with an oxide layer through deep
reaction ion etching (RIE). The thickness of the diaphragm was
determined by the thickness of the grown oxide layer on the silicon
substrate. This method promises that a diaphragm with control-
lable and uniform thickness can be achieved. The fiber was prepared
by splicing a piece of MMF with the SMF followed by cleaving the
MMF so that approximately 30–40 �m length of the MMF was left.
The FP cavity was formed by immersing the fiber with the MMF end
in a 49% HF. Finally, the silicon diaphragm was thermally bonded
onto the end of the etched fiber by a torch. The microscopic pho-
tographs of a fabricated sensor are illustrated in Fig. 2.
The independent fabrication of the diaphragm eliminates the
necessity of the bulky sensor head introduced by the support-
ing structure [20–22]. The robustness of this structure has been
demonstrated in various pressure measurement applications [15].
The uniform diameter of the sensor head keeps the sensor to its
minimized dimension and allows the following package procedure.
2.3. Package
As shown in Fig. 2, the pressure sensor is fabricated on a bare
fiber, which is about the size of a human hair without any outside
protection such as buffer or jacket. The bare fiber is made of pure
glass (silica) with special doping and its performance and long-term
durability can be affected by environmental conditions. Directly
exposed to the complex blood vessel circumstance, the fiber, espe-
cially the fragile diaphragm, is prone to be broken and the optical
signal will be not accurate. Therefore, utilization of the fiber optic
sensor as a medical device requires a delicate protection. In addi-
tion, a steerable tip section and a biocompatible coverage are also
required in in vivo blood pressure measurement applications.
The schematic of a fully packaged fiber optic sensor is shown in
Fig. 3, and the photograph of the tip section of a packaged sensor
is illustrated in Fig. 4. There is a Kapton tubing covered around the
stripped bare fiber to protect it from the external force. The Kapton
tubing and coil reinforced Kapton tubing work together as an enclo-
sure around the delicate fiber tip to prevent surrounding touch.
The Kapton tubing has openings which allow the outside media
174 N. Wu et al. / Sensors and Actuators B 181 (2013) 172– 178
Sensor tip
(125 μm)Polymer bead
Pun ched Kapton tubing Coil re inforce d Kapton tubingCoil
Fiber (250 μm) Stainless stee l tubing
Fig. 3. Schematic of the packaging design.
Fig. 4. Photograph of the tip section of a packaged sensor.
to interact with the fiber sensing area. A stainless steel coil with a
polymer head is bonded on the tip area for flexible steering. All of
the covering materials are either biocompatible polyimide or with
polytetrafluoroethylene (PTFE) coating. The mechanical properties
of different sections of the fully packaged device vary for steer-
able tip, flexible middle and stiff extension. The packaging length is
longer than 1.5 m for swine model usage. The final outer diameter
(OD) is around 360 �m which is close to commercial guide wires
for medical applications.
3. Sensor verification
3.1. Experimental setup
Prior to the animal test, static experiments were performed
to investigate the sensor’s static performance. Fig. 5 shows the
schematic diagram of the experimental setup. The fiber optic sen-
sor was placed in a sealed chamber in which the pressure was
controlled by a pressure controller (NetScanner Model 9034, Pres-
sure Systems Inc.). The sealed chamber was filled with water to
simulate the internal environment of the swine artery. In order to
compensate the bending loss occurred when the fiber optic sen-
sor travels through the coronary artery during the animal test, an
interrogation system with the capability of detecting the bending
loss was introduced [23]. A wideband light source (OEBLS-200, O/E
Land Inc.) was used to excite the fiber optic sensor through a cir-
culator. The reflected light was split into two optical fibers through
a splitter. One of the optical fibers was connected to a photodetec-
tor (PDA10CS, Thorlabs) through a tunable filter (FOTF-025121333,
Sealed chamber
Pressure
controller
Fiber optic BP sensor
Wideband light
source
Photodetectors
Circulator
Tunable filter
Splitter
Broadband
channel
Narrowband
channel
Fig. 5. The schematic diagram of the static experimental setup.
Agiltron). This channel was referred as the narrowband channel.
The other optical fiber was directly connected to another pho-
todetector (PDA10CS, Thorlabs). This channel was referred as the
broadband channel.
In the narrowband channel, the reflected interference spectrum
from the fiber optic sensor can be observed because that the coher-
ence length was much longer than the FP cavity length in the
sensor. On the contrary, there is no interference can be observed
in the broadband channel because the coherence length was much
shorter than the FP cavity length in the sensor. Therefore, the pho-
todetector in the narrowband channel is used to interrogate the
sensor while the photodetector in the broadband channel is used
to detect the bending loss [23].
3.2. Sensor calibration
A typical reflection spectrum of a fiber optic blood pressure sen-
sor is shown in Fig. 6a and the calibration results of the sensor when
the peak wavelength of the tunable filter was set to 1547.5 nm
are shown in Fig. 6b. The pressure in the chamber was increased
from 0 mmHg to 200 mmHg with steps of 50 mmHg and then was
decreased from 200 mmHg to 0 mmHg with the same steps. The
results indicate that the sensor has a low hysteresis and a high
repeatability according to low standard deviations. The sensitivity
was calculated as 0.035 mV/mmHg.
4. Intravascular blood pressure measurements
4.1. Protocol of animal test
A 25–50 kg Yorkshire swine was premedicated with intramus-
cular Glycopirrolate B (0.01 mg/kg) and an anesthetic cocktail
(5 mg/kg Telazol; 2.5 mg/kg Ketamine; 2.5 mg/kg Xylazine) after
which endotracheal intubation was performed. Anesthesia was
maintained with inhalational 2–3% isoflurane. Next, femoral arte-
rial access was obtained via cutdown, and a 6 French introducer
sheath was inserted. Heparin was administered intravenously
(50 units/kg), and a 6 French JR-4 guide catheter (Medtronic; Min-
neapolis, MN) was guided to the aortic arch. Baseline blood pressure
measurements were obtained with standard invasive manometry.
Fiber optic blood pressure measurements were similarly obtained
for comparison offline.
The guiding catheter was advanced to the aortic arch. In order
to demonstrate the capability of capturing heart beat signals, the
blood pressure was measured by the fiber optic blood pressure sen-
sor at two points: the aortic arch and the right coronary artery.
The blood pressure at the aortic arch was measured when the fiber
optic sensor was outside the catheter. The blood pressure at the
right coronary artery was measured when the fiber optic sensor was
inside the catheter. Finally, a 2.25 mm balloon (Quantum Maverick,
Boston Scientific) was inserted into the catheter to mimic stenosis.
The blood pressure was measured by the fiber optic sensor when
the balloon was inflated and deflated.
4.2. Blood pressure measurements in aortic arch
Fig. 7a shows results of a period of the blood pressure measure-
ment taken by the fiber optic blood pressure sensor in the aortic
arch. The results from the fiber optic sensor are consistent to the ref-
erence manometer, which are shown in Fig. 7b. The pressure range
was from 54 mmHg to 88 mmHg and the heart beat was approxi-
mately 83 beats per minute (bpm). The fiber optic blood pressure
sensor demonstrated its capability of capturing heart beat signals
in this measurement.
N. Wu et al. / Sensors and Actuators B 181 (2013) 172– 178 175
1520 154 0 156 0 158 0-50
-45
-40
-35
-30
-25
-20
(a)
Inte
nsi
ty (
dB
)
Wavelength (nm)
1547.5 nm
0 50 100 150 200
9
10
11
12
13
14
15
16
17
(b)
Volt
age
(mV
)
Pressure (mmHg)
Increase
Decrease
Fig. 6. (a) The typical reflection spectrum from a fiber optic blood pressure sensor. (b) The calibration results when the peak wavelength of the tunable filter was chosen at
1547.5 nm.
Fig. 7. (a) Blood pressure measurements at aortic arch outside the catheter by fiber optic pressure sensor. (b) Blood pressure measurements taken by the reference manometer.
4.3. Blood pressure measurements in the right coronary artery
In order to reach the right coronary artery, the fiber optic blood
pressure sensor had to pass through the aortic arch where the
optical fiber suffered a huge optical intensity loss due to the big cur-
vature of the aortic arch. Therefore, it is critical to identify when the
optical fiber suffers the optical intensity loss. The interrogation sys-
tem of the fiber optic sensor has the capability to identify the optical
fiber bending loss. The broadband channel in Fig. 5 was used to cap-
ture the optical intensity drop caused by the bending loss because it
is insensitive to the blood pressure variation. Therefore, the signal
from the broadband channel was used to compensate the bend-
ing loss of the optical fiber. The electrical voltage signals from both
broadband and narrowband channels are shown in Fig. 8a. At about
249 s, the fiber optic sensor was advanced to the right coronary
artery and was suffered from the bending loss. It can be seen from
both channels that there were huge voltage drops. The difference
magnitude of the voltage drops was due to the different gain set-
tings of photodetectors. After identified that the signal drops were
caused by the bending loss, the signals from the broadband chan-
nel was used to compensate the signal drops in the narrowband
channel, which is shown in Fig. 8b.
220 230 240 250 260 270 280 290 300
10
11
12
13
14
10
11
12
13
14220 230 240 250 260 270 280 290 300
Narrowband channel
Volt
age
(mV
)
Time (s)
(a)
Advanced to right
coronary artery
Broadband channel
220 230 240 250 260 270 280 290 300
10
11
12
13
14
10
11
12
13
14220 230 240 250 260 270 280 290 300
(b)
Narrowband channel
after compensation
Volt
age
(mV
)
Time (s)
Narrowband channel
Fig. 8. (a) Signals from the photodetectors in both channels when the fiber optic sensor was subjected to a severe bending. (b) Signals in narrowband channel after the
compensation.
176 N. Wu et al. / Sensors and Actuators B 181 (2013) 172– 178
Fig. 9. (a) Blood pressure measurements at the right coronary artery in the catheter by fiber optic pressure sensor. (b) Blood pressure measurements taken by the reference
manometer.
The blood pressure measured by the fiber optic sensor is shown
in Fig. 9a. The signals from the fiber optic sensor and the reference
manometer (Fig. 9b) are not very consistent. The inconsistence was
due to the different locations of the fiber optic sensor and the ref-
erence manometer. The fiber optic sensor was inside the catheter
while the manometer was on the tip of the catheter. The blood
pressure inside the catheter may be different from the outside pres-
sure due to the presence of the catheter. However, the pressure
range obtained from the fiber optic sensor was from 60 mmHg to
100 mmHg, which is consistence with the reference manometer
(from 60 mmHg to 96 mmHg). It can be observed that the systolic
and diastolic pressures at the right coronary artery taken by both
fiber optic sensor and the reference manometer are higher than
those taken at the aortic arch.
4.4. Blood pressure measurements with balloon
After measuring the blood pressure at different locations, for
the purpose of demonstrating the fiber optic blood pressure sen-
sor in FFR applications, a 2.25 mm balloon was inserted into the
catheter to mimic stenosis. The blood pressure will drop when
the balloon inflates while the blood pressure will resume when
the balloon deflates. The inflation/deflation cycle was repeated 3
times. Fig. 10 shows electrical voltage signals from both broad-
band and narrowband channels. According to the voltage shift
from the broadband channel, the curvature of the blood ves-
sel was changed when the balloon was inflated. Therefore, huge
0 20 40 60 80 100 120 140 16013.8
13.9
14.0
14.1
14.219
20
21
22
230 20 40 60 80 100 120 140 160
Broadband channel
Volt
age
(mV
)
Time (s)
Narrowband channel
Fig. 10. Electrical voltage signals from both broadband channel and narrowband
channel.
changes of the baseline from the narrowband channel can be
observed.
Fig. 11 shows blood pressure readings from the fiber optic sen-
sor for the whole inflation/deflation procedure after compensation
by the broadband channel. It can be clearly seen that there are 3
cycles of balloon inflation and deflation. When the balloon was
inflated, the peak to peak amplitude of the blood pressure was
decreased. After the balloon was deflated, the peak to peak ampli-
tude of the blood pressure was resumed. The detailed information
of the blood pressure at each transient period are illustrated in
Table 1.
A big increase of the blood pressure can be observed when the
balloon was inflated for the first time. The same blood pressure
raise was shown to the reference manometer as well. The blood
pressure was out of the reading range in the reference manometer.
It might be because the pressure was built up when the balloon
inflated. However, in practical FFR applications, the peak to peak
amplitude of blood pressure signals is more important and there
is no pressure accumulation in FFR applications. In the second and
the third inflation/deflation cycle, the peak to peak value of the
blood pressure variation can be observed. Readings from the fiber
optic sensor and the reference manometer are consistent. During
the inflation of the balloon, the amplitude of the blood pressure
dropped while the amplitude of the blood pressure increased when
the balloon was deflated.
0 50 10 0 15 00
20
40
60
80
100
120
140
160
180
200
220
Inflated the b alloon
(blood pressur e drops)
Blo
od
pre
ssu
re (
mm
Hg
)
Time (s)
Fig. 11. Blood pressure readings of the whole inflation/deflation procedure from
the fiber optic sensor after compensation.
N. Wu et al. / Sensors and Actuators B 181 (2013) 172– 178 177
Table 1Transient blood pressure readings from the fiber optic sensor and the reference manometer for all three inflation/deflation cycles.
Transient period Fiber optic pressure sensor readings Reference manometer readings
First inflation
First deflation
Second inflation
Second deflation
Third inflation
Third deflation
178 N. Wu et al. / Sensors and Actuators B 181 (2013) 172– 178
5. Conclusions
In this paper, a miniature fiber optic blood pressure sensor for
FFR applications was designed, fabricated and tested in a swine
model. Static experiments were performed to verify the sensor’s
performances. In vivo experiments were performed by using a
swine as the animal target. In order to compensate the bending loss
from the optical fiber caused by the big curvature at the coronary
artery, a special interrogation system was designed.
Blood pressure was measured at different locations in the coro-
nary artery to demonstrate the capability of the fiber optic sensor
for capturing heart beat signals. The bending loss caused by the cur-
vature of the coronary artery was compensated by the interrogation
system very well. In order to demonstrate the sensor’s usage in FFR
applications, the drop and recovery of the peak to peak BP ampli-
tude caused by the balloon-mimic stenosis were recorded by the
fiber optic sensor successfully. Due to its compact size and all opti-
cal operation principle, such fiber optic sensors have wide potential
applications in medical area.
Acknowledgment
The authors would like to thank University of Massachusetts
Medical School for providing swine and proceeding the surgical
procedure.
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Biographies
Nan Wu completed his PhD degree in Department of Electrical and Computer Engi-neering at University of Massachusetts Lowell (2012). He is now working as thepostdoctoral researcher at UMass Lowell. His research interests include fiber opticpressure sensors, fiber optic photoacoustic generators, and photoacoustic imaging.
Ye Tian received his MS degree from the Institute of Modern Optics of Nankai Uni-versity in 2008. He is now pursuing his PhD degree in the Department of Electricaland Computer Engineering, UMass Lowell. His research interests are biosensors,fiber optic sensors, MEMS, and FIB.
Xiaotian Zou received his MS degree in Mechanical Engineering at the Universityof Connecticut in 2010. He is a PhD candidate in the Department of BiomedicalEngineering and Biotechnology, UMass Lowell. His research interests are controland data analysis algorithms for bio-systems and optical biosensors.
Yao Zhai received his MS degree from Institute of Semiconductors, Chinese Aca-demic of Sciences (2010), BS degree from Tianjin University (2007). He is a PhDcandidate in the Department of Electrical and Computer Engineering at UMassLowell. His research interests are quantum dot photodetectors.
Kurt Barringhaus is an assistant professor of Medicine at the University of Mas-sachusetts Medical School. His research interest is in coronary artery physiology.
Xingwei Wang is an associate professor in Department of Department of Electri-cal and Computer Engineering at UMass Lowell. Her expertise are optical sensorsfor medical, chemical and industrial applications; assistive technology program;nanoprobe design and fabrication; self-assembled nanostructures; optical biosens-ing and biomedical devices; optical imaging; MEMS technology and electromagneticwave propagation.