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Heprintt>d from )OUHNAL OF CL!

NICAL ENGINEEIUNG
Vol. 21, No. l Januarv/Fcbruary 1996
Lppincott-1\aven Publishers Printed in U.S.A.
Effects lnduced by a Membrane Oxygenator on
the Pressure Exerted by a Roller Pump far
Extracorporeal Circulation
F.P.BRANCA
P. CAPPA
F. MASTRANTONIO
Department of Mechanics and Aeronautics, University of Rome "La Sapienza," /taly
An experimental analysis was carried out to evaluate the effects induced by a membrane
oxygenator on the pressure exerted by a roller pump in a hydraulic circuit for extracorporeal
circulation (ECC). The research was conducted with two catheter pressure transducers whose
signals were gathered by means of an automatic data acquisition system. The tests were
carried out using a blood substitute (Emagel"') that shows density and viscosity values similar
to those of the hemodiluted blood. An overall examination of the obtained results, with a circuit
simulating an ECC system used in the operating room, allows a quantification of the
noticeable reduction in amplitude and bandwidth of the pressure wave, measured in the aortic
arch of the patient. A membrane oxygenator seriously limits any effort, in ECC, to reproduce a
physiological wave in order to have a correct blood perfusion.
lndex Under: Blood Oxygenator; Oxygenator, Blood; Pressure Monitoring; Monitoring, Pressure; Catheter
Transducers; Transducers, Catheter; Extracorporeal Circulation.
INTRODUCTION
Exrrac01poreal circularion (ECC) is a technique that
has been known for 30 years. It enables replacement of
the patient's cardiac and pulmonary functions during
open-heart surgery by an artificial heart-lung system
1
A
hydraulic circu t utilized in ECC can be schematized as:
(l) a pump, which provides the blood with a load suffi-
cient to overcome the hydraulic resistance
2
-
6
; (2) an oxy-
genator, which replaces some carbon dioxide with
oxygen at the correct rate
7
; (3) a beat exohanger, which
regulates blood temperature lo induce systemic hypoth-
ermia; and (4) a reservoir capable of assuring the con-
tinuous operation of the pump by receiving the venous
blood and returning this blood through the oxygenator
on the arteria! li ne (see Figure I).
An analysis of the literature shows that blood oxy-
genation is the most pertinent difficulty that surgeons
and researchers had lo face and, up to now, it has not
been solved
8
-
9
Nowadays, the most widely used oxy-
genation technique is based on the membrane oxygen-
ators (see Figure 2), which show a behavior more similar
to lungs than the bubble ones. In a membrane oxygen-
ator, the gas exchanges occur by means of a semiperme-
able membrane placed between a gas mixture and blood,
reproducing, even if roughly, the human lung functions
10
-
12

Experimentaltest results bave pointed out the following
advantages over using membrane oxygenators: (l)
smaller platelet damage
13
-
14
; (2) a decrease of hemolytic
levels
1
\ (3) a better safeguard of the re n al function
15
;
and (4) beller postoperative cardiac function and neuro-
logica! status in patients for whom a membrane oxygen-
ator has been used in cardiovascular by-pass lasting more
than two hours
15
Though contrasting results h ave been
reported in the literature, the decrease of the pulsatile
flow caused by the oxygenator utilization in arterialline
16
worsens peripheral perfusion and, consequently, pro-
duces negative effects both on hemodynamic factors and
o n metabolic 'an d histological ones
17
"
21

Furthermore, baroceptor response is significantly
greater for pulsatile than for nonpulsatile pressure
because of the well-known sensitivity of these receptors
to rate of pressure change (dp/dt). One effect of increased
baroceptor activity in response to pulsatile pressure is
Journal of Clinica! Engineering Vol. 2 I, No. I, January/Febnwry, I 996 Copyrighl (!) 19'!6, Quest Publishing Co. l ne.
Jranca et aL Journal of Clinica! Engineering-January/February 1996 55
Venous retourn
+--
Reservoir
Roller pump
Figure 1
Membrane
Oxygenator with
beat exchanger
Basic extracorporeal circulation (ECC) scheme.
the inhibition of the firing rate and, consequently, the sym-
'thetic efferents contributing to constrict blood vessels
22

In a membrane oxygenator, such as that utilized
in the present study, the blood flows through a kind of
envelope obtained by facing two semipermeable mem-
branes. The main problem of this configuration lies in
keeping the distance between the two surfaces constant,
as well as when varying the pressure at which the blood
perfusion occurs. The Poiseuille law shows that a small
variation of the distance between the two membranes
strongly changes the pressure drop and the subse-
quent flow resistances; under this condition, such a devi ce
acts on the extracorporeal circuit as a filter of the pres-
sure signa!.
From these observations it emerges that, in design-
ing and realizing an ECC circuit, it is necessary to bave
some information about the hydraulic resistances induced
in the hematic line by the presence of a membrane oxy-
genator. The patient's pressure is related to blood flow
through the overall of the external circuit and
ascular bed, and this knowledge enables the optimiza-
_.on of organ perfusion
23

To the authors' knowledge, detailed data about mem-
brane oxygenators are not available. This study deals
with an experimental evaluation of the effects induced
by such devices on the pressure time variations exerted
by a roller pump widely used in ECC. It was decided to
monitor the pressure exerted by this pump inside the tube
in two locations- at its delivery section and at the oxy-
genator outlet with a hydraulic circuit that resembles
those actually utilized in operating theaters. The pres-
sure values were determined by means of a catheter
hydraulically coupled with a pressure transducer spe-
cific for biomedica! applications. Because hydraulically
coupled systems usually have a narrow bandwidth and
an insertion error from the presence of the catheter in
the circuit, however, the dynamic response of the
catheter-transducer system was preliminarily verified in
actual use conditions.
56 Journal ol Clinica! Engineering---January/February 1996
EXPERIMENTALSETUP
To carry out the study reported bere, a hydraulic cir-
cuit was set up in vitro to simulate, as accurately as pos-
sible, an ECC system used in operating rooms. According
to the scheme showed in Figure 3, a membrane oxygen-
ator with integrated beat exchanger and a cardiotomy
reservoir were assembled in series behind a roller pump
by employing 2.6 m of lO mm internai diameter PVC
tube of the type commonly used in ECC. Creating a
hydraulic circuit similar to that used in vivo required a
head of about 50 mmHg between the measurement sec-
tion after the oxygenator and a cardiotomy reservoir
employed as a patient simulator in the present set up;
the previously indicated pressure value is equivalent to
the one exerted by an Emagel'" column = 660 mm high.
The utilized head was chosen to simulate a steady-state
condition, as suggested by heart surgeons, of the mean
pressure that the blood flow has to overcome at the
cardiopath 's aortic cannula entrance.
Figure 4 shows the measurement system adopted to
monitor the pump output as a function of the time. It
consists of: (l) two piezoelectric pressure transducers;
(2) two modules for pressure and temperature record-
ings provided with digitai signa! processing; (3) a ther-
mistor specific for clinica! applications to determine flui d
Figure 2
Disposable membrane oxygenator with integrai heat exchanger.
Branca et al.
Reservolr
80mm 4easuring J>Oinl #2
Figure 3
660mm
Membrane
oygenalor
In vitro heart lung bypass circuit to evaluate membrane oxy-
genator performances.
temperature; (4) a chromel-alumel thermocouple to pick
up the laboratory temperature; (5) two antialiasing low-
pass filters; and (6) an automatic data acquisition system
based on the IEEE-488 busto collect, analyze, and store
'he experimental data. The automatic data acquisition
system may be schematized as: (l) a computer that
controls the instruments, and (2) a data acquisition unit
(DACS) equipped with a solid-state relay multi-
plexer and a high-speed digitai voltmeter (DVM-HS)
capable of acquiring up to 100,000 readings/s with a 13-
bit resolution.
The pump rotation speed was determined with an
optical technique (marker and emitter-receiver photo-
diode) characterized by an uncertainty of about IQ-
2
Hz.
Data Acquisition Control System (DACS)
HP 3852A
Available
slots
High speed
DVM
HP4470B
Solid state relay
multiplexer
HP 44708F
Siemens Sirecust 404
p
T
Temperature module
Figure 4
Schematic of the measuring experimental setup .
.Jranca et al.
METROLOGICAL PERFORMANCE OF THE
MEASUREMENT SYSTEM
The linear behavior of the pressure transducer gradu-
ation curve in the range 0-200 mmHg (linear correlation
coefficient r egual to 0.99) and its repeatability (data
spread < 0.6 mmHg) were preliminarily verified.
Then, snap tests were carried out to evaluate dynamic
response characteristics of the catheter-transducer system.
Such an experimental procedure was necessary because of
the dependence of the system bandwidth on: (l) the fluid
flowing in the circu t, and (2) the compliance of the cho-
sen tube for the extracorporeal circuit. With the snap
test
24
-
26
it is possible to characterize the in vivo dynamic
behavior of a fluid-filled blood pressure transducer and
its catheter when they can be approximated as a second-
order system. This experimental technique consists of
using a water-hammer effect obtained by suddenly stop-
ping the flui d flow by means of a rapi d closure of a flush
valve and in recording the pressure system output. The
system bandwidth at -3db attenuation was evaluated in
0-35 Hz, using norma! saline and with test area tempera-
ture variations in the range of 22-24C. Such a band-
width seems to be sufficient, though narrow, considering
that with the usual pump rotation speed, heart surgery in
children determines pressure variations as functions of
ti me whose fundamental frequency is between l and 5Hz.
EXPERIMENTAL PROCEDURE
AND TEST RESULTS
The tests carri ed out to de termine the performance of
membrane oxygenators were conducted using a blood
D !I::I:DI
1111111111111111111111111
a
Thermocouple type K
Journal of Clinica! Engineering-January/February 1996 57
substitute instead of bovine blood to facilitate the con-
duction of the experimental analysis; the chosen substi-
tute was Emagel which, in the same circumstances, can
replace human blood up to 80%. The 3.5% Emagel solu-
tion shows characteristics of density and viscosity simi-
lar to those of blood in the ECC circuit hemodiluted an d
treated with anticoagulants (for example, heparin).
The measuring points were: (l) the pump delivery sec-
tion, and (2) the patient's entrance section, identified as #l
an d #2, respecti ve! y. The measuring poi n t# l was chosen a t
a distance of about 80 mm from the pump outlet, and mea-
suring point #2, which simulates the entrance into the
patient's aortic arch, was located after the filter-oxygenator
and was at h = 660 mm under the reservoir that acts as
the patient simulator. This height was chosen, as previ-
ously pointed out, to simulate, in steady-state condition,
the mean pressure at the aortic arch entrance.
The tests were conducted imposing rotation speeds
in the range of 40-120 rpm corresponding to the neces-
sary flow rate to ensure the patient's survival. The cho-
sen rotation speeds with the utilized plastic tube in the
extracorporeal circuit determined a flow of = 1.9-5.9 1/
min if the ro1ler pump was considered, in a first
approximation, a volumetric one. Pressure monitoring was
carried out with temperature conditions that represent the
different bypass techniques: (1) hypothennia at l8C; (2)
environmental temperature at 25C; and (3) normothermia
at 37C. The comparison between the oxygenator input
signa! and the output one was performed both in time
and in frequency domai n and, to digitize the signals, the
DVM-HS was set at a sampling frequency of 500Hz.
In regard to time domain analysis, plots relative to tests
conducted at a roller rotation speed of 40 and 120 rpm
using Emagel at 25C are shown in Figure 5. A noticeable
fluctuation of the signa! amplitude emerges from an analy-
sis of the pressure variations in the #l location, followed
by a damped oscillati o n characteristic of 2nd order sys-
tems because of the elastic flow of the tube caused by
the beginning of the pumping action. This is an impor-
!B)
1 2 1 4
hme(s)
(#1)
'" i f\
so . ..-------

a.
16 1 8
[vvl
1 2 1 4 16 18

o 02 04 06 08
hme{s}
Figure 5
Pressure variation versus t ime measured before ( # 1) and after
(#2) the membrane oxygenator; pump rotation speed (A) 40
rpm, (B) 120 rpm.
58 Journal of Clinica! Engineering-January/February 1996
l
140

1
! measunog polnt "] l
il
100
l "' measunog polnt 2
! w - '
i .- : -.:-. ..... :.:;,., .-]
40 50 w 70 w 1>0 100 110
rpm
Figure 6
Mean pressure versus pump rotation speed, Emagel tem-
perature of 25C, before (#1) and after (#2) the membrane
oxygenator.
tant cause of hemolysis because of red cells between the
hematic line being squashed by the rolls
23
In the mean-
time, this relevant pressure signa! fluctuation is dramati-
cally reduced and dephased by the oxygenator, as comes
out from the signa! measured at the #2 location.
To evaluate the global effects induced by the oxy-
genator at different pump rotation speeds, following
parameters w ere chosen: (l) mean pressure P computed
over a window lasting for 2 s for the offset evaluation,
an d (2) the pressure root mean square P reduced of P
for the pulsatile component The values
obtained by using Emagel at 25C are shown in Figures
6 and 7 as a function of pump rotation speed. An analy-
sis of these plots points out a behavior of P nearly Iinear
with the rotation speed both in section #l (r = 0.99) and
in section #2 (r = 0.98). The variation range of P is 100-
190 m m Hg a t# l an d 54-64 m m Hg a t #2, with a consid-
erable reduction of the patient's mean pressure. The
results obtained with P exhibit not only a linear behav-
rms
1or (r 0.92) but also an attenuation of the pressure pul-
satile component at the patient location; the p nns values
are in the ranges of 20-76 mmHg and 3-4 mmHg at the
measuring point #l and #2, respectively.
The pressure signa! frequency analysis has been per-
fonned with a specilc program compi led with Matlab lan-
guage. A comparative examination of the data obtained
underlines the wider band of frequencies of the pressure
signa! before the oxygenator, whose information contribu-
tion for the spectrum estimation is of unti! the
60
70
c;
r 80
e
. 50
e measunng point 11 l
;:
40
30
6- 12
Q.
e
20
0:
101
=25c

o
40 50 60 70 60 90 100 110
rpm
Figure 7
Root mean square pressure versus pump rotation speed,
Emagel temperature of 25C, belo re (# 1) and after (#2) the
membrane oxygenator.
Branca et al.
(A)

o 1 o 1 5 20 25 30 35 40
Frequcncy (Hz]
(B)
w"l
10
1
(\
I 1/1\ Il \ (\ (\
V\)\)
10
30 35 40 45 so
Frequoncy (HzJ
Figure 8
Power density spectra of pressure signa! before (A) and alter
(B) the membrane oxygenator.
7th hannonics, while after the oxygenator it is significant
'nly unti! the 5th. The results obtained for different pump
. otation speeds ha ve shown that the signa! power density at
Iocation #l is distributed in a 0-30 Hz band larger than
those measured a t Iocation #2, which is about 0-15 Hz. Fur-
thermore, from a global exarnination of the results, there
also appears to be a relevant power signa! reduction after
the oxygenator; such a result seems to be caused by the
compliance of the oxygenator 's structure. In Figure 8 the
graphs relative to a pump rotation speed of 120 rpm are
shown as an example, and the graph for the #2 measuring
poi n t underlines a power reduction of a l 0
3
factor
the signa! between the l st an d the las t observed harmomc.
Moreover, an examination of Figure 9 shows the oxy-
genator transfer function amplitude IH(f)F, the relevant
attenuation ofthe pulsatile component appears; this phe-
nomenon determines, as a consequence, a noticeable
reduction of: (I) the pump physiological behavior, and
10
ta'
ta'
\)0 l
N
!..
StO
:!;.


10
_,
10
o 2 6 6 10 12 14 16 16 20
Frequency [Hz)
Figure 9
Oxygenator transfer function (amplitude).
.inca et al.
o 60
Figure 10
(mea:wnng potnt 11)
80 100
rpm
120
'0 Em&geltemperawre 1ec
: DEmegeltemperalurt' 25"C
, JEmegel temperature 37"C
Histogram of mean pressure as a function of roller pump rota-
tion speed and Emagel temperature; before the membrane
oxygenator.
(2) the necessary power fora peripheral bed correct
fusion. The observed power loss is also due to the hematlc
line between measuring point #l and the oxygenator in-
Jet (:: 0.5 m). Therefore, any design effort to reproduce
as much of a physiological pressure wave as possible
with an ECC pump is fruitless because of the utilization
of oxygenators such as the kind considered i? this .
Next, the behavior of the oxygenator wtth an 18 C
flowing Emagel was examined; the results are shown in
Figures 10-13. By examining the histograms, and from
a comparative examination of data obtained with Emagel
at 25C, an irrelevant variation of the effect induced by
the oxygenator when varying t!!_e fluid temperature can
be deduced ( variation range of P: 100- I 92 mmHg a t #l
and 55-64 mmHg at #2, r 0.98; variation range of P nn,:
22-76 mmHg at #l, 3-4 mmHg at #2, r 0.89). More-
over, because the operations conducted in hypothermia
(at l8C) Iasted for:: 3h, i t was decided to continuously
monitor the pressure in this interval. Even in this case,
unnoticeable variations of the pressure waves with
respect to the formerly described test were observed.
Finally, Emagel at 37C was used, and the results are
shown in Figures I 0-13. These results, compared with those
obtained with the fluid at I 8 and 25C, point out that the
effects induced by the on the ECC circuit are
constant ( variation range of P: 91- I 91 m m Hg at #l, 59-65
mmHg at #2, 0.98; variation range ofPnns: 23-74 mmHg
at #l, 3-3.5 mmHg at #2, r = 0.98 at #l and 0.3 at #2).
{measunng pomi 12)
64
o 80 80 100
rpm
Figure 11
:'r-
120
l
i J
lo 18"C
i a Emagellemperature: 25"C
l 37"C
Histogram of mean pressure as a function of roller pump rota-
tion speed and Emagel temperature alter the membrane
oxygenator.
Journal of Clinical Engineering-January/February 1996 59
80 - ..
70 :
60 l
40
Figure 12
60
(measunng poinlt1)
60 100
rpm
120
l
c. . ------- --
I
lo Emagel Temperature: 1ac
l Emageltemperaturo: 2sc
11. Emaoellemperature: 3J-C
l ~
l
Histogram of root mean square pressure as a function of roller
pump rotation speed and Emagel temperature before the mem-
brane oxygenator.
Thus, it can be asserted that the effects induced by
the oxygenator are independent of the length of cardio-
vascular bypass and from the flowing fluid temperature;
therefore, it is reasonable to believe that the observed
small mean pressure shifts among the tests depend only
on the eiastic behavior variations of the tube, which is
te hematic line in the ECC circuit.
CONCLUSIONS
The utilization of an oxygenator in the ECC circuit
obviously determines a power loss of the pressure sig-
na!. Considering that the actual flow and pressure fields
along the circuit depend on the hydraulic resistance
exerted by the components (for example, pipe, oxygen-
ator, aortic cannula), however, it is a quantification of
the effects induced by the oxygenator.
The experimental tests described here have made it
possible to estimate the effects induced by membrane
oxygenators in an ECC circu t as: (l) mean pressure
provided to the patients, (2) root mean square of the pul-
satile component, an d (3) bandwidth of the pressure sig-
na! power spectral density.
Moreover, the flowing fluid temperature, such as the
bypass lasting, do not noticeably affect the pressure fluc-
wtions as a function of ti me after the oxygenator. Such
vbservations point out that any effort to design ECC
pumps capable of reproducing pressure physiological
(measunng polnt 12)
4,5,---------------,
3,5
3 .-, ,-
~ 2,5
~ 2
1,5
1
0,5
40
Figure 13
60 60
rpm
;;.
-.
100 120
Histogram of root mean square pressure as a function of roller
pump rotation speed and Emagel temperature alter the mem-
brane oxygenator.
. ~ 0 Journal of Clinica! Engineering-January/February 1996
waves is seriously limited by the presence of a mem-
brane oxygenator in the arteria! line.
ACKNOWLEDGMENTS
The authors wish to thank Dr. Costa at the Depart-
ment of Heart Surgery of the Children's Hospital
"Bambino Ges," Rome, for her helpful cooperation and
Mr. Francesco Rapanotti, technician at the Department
of Mechanics andAeronautics of the University of Rome
"La Sapienza" for his skillful technical assistance.
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o1anca et al.
BIOGRAPHIES
FRANCESCO PAOLO BRANCA
Francesco Paolo Branca received the Laurea degree in Electrical Engineer-
ing in 1960 from the U niversity of Rome "La Sapienza," an d in 1961 joined
the Department of Mechanics and Aeronautics at the University of Rome
"La Sapienza" where he is currently a Full Professor of Mechanical Mea-
surements and in charge of Electromedical Devices. H e is currently Profes-
sor of Biomedica! Instrumentation for Anesthesia and Safety at the School
of Specialization in Anesthesia and Intensive Care at the Catholic Univer-
sity "Sacro Cuore" of Rome and Scientific Director of a cooperation pro-
gram between Italy and Tunisia for Biomedica! Equipment Maintenance at
the Center of Technical Studies for Biomedica! and Hospital Maintenance
of Tunis. Since its establishment ( 1981) he has bee n the Director of the
Clinica! Engineering Service at the Children's Hospital "Bambino Ges"(:
730 bed medicai facility). which is a private and nonprofit-making hospital
located in Vatican City, and is officially recognized by the Italian govem-
ment as a Research and Care lnstitute of a Scientific Nature. His main scien-
tific interests are in the areas of generai instrumentation, ex peri menta! stress
analysis, biomedica! instrumentation and clinica! engineering.
PAOLO CAPPA
Paolo Cappa received with honors the Laurea degree in Mechanical Engi-
neering in 1980 from University ofRome "La Sapienza" and in 1981 joined
the Department of Mechanics and Aeronautics at the University of Rome
"La Sapienza" where he is currently an Associate Professor of Sensors for
Mechanical Measurements. Since its establishment (1981 ). he has been the
Assistant Director of the Clinica! Engineering Service at the Children's
Hospital "Bambino Ges." He is currently involved in a cooperation pro-
gram between ltaly and Tunisia for Biomedica! Equipment Maintenance at
the Center of Technical Studies for Biomedica! and Hospital Maintenance of
Tunis. His mai n scienti fie interests are generai instrumentation, ex peri men-
ta! stress analysis, electromedical equipment management, biomechanics of
teeth, metrological studies of gait analysis system performances and bio-
medicai sensors.
FABRIZIO MASTRANTONIO
Fabrizio Mastrantonio received the Laurea degree in Mechanical Engineer-
ing in 1993 from University of Rome "La Sapienza" and in the same year
joined the Department of Mechanics and Aeronautics at the University of
Rome "La Sapienza" as a Research Associate. He is currently studying fora
Ph.D. in Mechanical Measurements. In 1994 he was awarded the Certificate
of Proficiency in Biomedica! Signa! Analysis from the University of Rome
"La Sapienza" for best thesis. His scientific interests include biomechanics
of teeth, biomedica! sensors and biomedica! instrumentation.
Address ali correspondence and reprint reguesls to P. Cappa, Department of
Mechanics and Aeronautics, University of Rome "La Sapienze," Via
Eudossiana, l 8-00 l 84, Rome, ltaly.
Journal ol Clinica! Engineering-January/February 1996 61

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