sensors

Article
An Implantable Sensorized Lead for Continuous
Monitoring of Cardiac Apex Rotation
Emanuela Marcelli and Laura Cercenelli *
Laboratory of Bioengineering, DIMES Department, University of Bologna, S. Orsola-Malpighi Hospital,
40138 Bologna, Italy; emanuela.marcelli@unibo.it
* Correspondence: laura.cercenelli@unibo.it; Tel.: +39-051-636-4603




Received: 15 October 2018; Accepted: 28 November 2018; Published: 30 November 2018


Abstract: Changes in the pattern or amplitude of cardiac rotation have been associated with important
cardiovascular diseases, including Heart Failure (HF) which is one of the major health problems
worldwide. Recent advances in echocardiographic techniques have allowed for non-invasive
quantification of cardiac rotation; however, these examinations do not address the continuous
monitoring of patient status. We have presented a newly developed implantable, transvenous lead
with a tri-axis (3D) MEMS gyroscope incorporated near its tip to measure cardiac apex rotation in the
three-dimensional space. We have named it CardioMon for its intended use for cardiac monitoring.
If compared with currently proposed implantable systems for HF monitoring based on the use of
pressure sensors that can have reliability issues, an implantable motion sensor like a gyroscope holds
the premise for more reliable long term monitoring. The first prototypal assembly of the CardioMon
lead has been tested to assess the reliability of the 3D gyroscope readings. In vitro results showed that
the novel sensorized CardioMon lead was accurate and reliable in detecting angular velocities within
the range of cardiac twisting velocities. Animal experiments will be planned to further evaluate the
CardioMon lead in in vivo environments and to investigate possible endocardial implantation sites.

Keywords: cardiac rotation; gyroscopes; implantable lead; heart failure; continuous monitoring

1. Introduction
Cardiac torsion is the wringing motion of the heart around its long axis created by oppositely
directed apical and basal rotations and is determined by contracting myofibers, which are arranged in
opposite directions between the subendocardial and subepicardial layers [1]. This motion is essential
for regulating cardiac systolic and diastolic functions and changes in the pattern or amplitude of
cardiac rotation have been associated with various cardiovascular diseases, such as hypertrophic or
dilated cardiomyopathy, aortic stenosis, myocardium ischemia, acute myocardial infarction, and Heart
Failure (HF) which one of the major health problems worldwide [1–3].
In the past cardiac rotation has been quantified using different methods, including multiple
implanted markers and biplane cine angiography in transplanted hearts [4,5] and optical devices [6].
More recently, the availability of advanced non-invasive imaging techniques such as tagged magnetic
resonance imaging, Doppler tissue imaging, and speckle tracking imaging have expanded the
understanding of the relationships between cardiac rotation and cardiac diseases. However,
such noninvasive examinations can be used only on an intermittent basis and are not intended
to continuously monitor cardiac rotation.
To date, the most significant advancement in the arena of implantable systems for HF monitoring
was taken with a novel, wireless, battery-less, pulmonary artery pressure (PAP) monitoring system
called the CardioMEMS HF System (Abbott, Sylmar, CA, USA) [7–9]. Other PAP measurement
systems are being developed, including a small, implanted sensor that has a battery in the capsule

Sensors 2018, 18, 4195; doi:10.3390/s18124195 www.mdpi.com/journal/sensors

Sensors 2018, 18, 4195 2 of 10

and talks through intrabody communication to a Reveal LINQ insertable cardiac monitoring device
(developed by Medtronic, Inc., Minneapolis, MN, USA) [10] and a system (developed by Endotronix,
Inc., Woodridge, IL, USA) for measuring PAP. This appears to be similar to the CardioMEMS HF
System, except for a different external user interface [10].
Currently, devices to monitor left atrial pressure (LAP), which is a direct reflection of left
ventricular filling pressure and therefore the primary pressure target for the HF management, are also
under development. The HeartPOD (Abbott, formerly St. Jude Medical/Savacor, Inc., Abbott
Park, IL, USA), a system that allowed for direct measurement of LAP, was studied in a prospective
randomized controlled study that was stopped early due to a perceived excess of implant-related
complications [11,12]. The V-LAP system (Vectorious Medical Technologies, Tel Aviv, Israel) is a next
generation of implantable LAP monitoring systems, which uses a miniature percutaneous wireless
and leadless LAP sensor associated with an advanced, onboard, application-specific, integrated circuit
that incorporates a novel drift compensation mechanism [10]. Another micro-electromechanical
systems–based LAP monitoring system (Integrated Sensing Systems, Inc., Ypsilanti, MI, USA) has been
evaluated in first-in-man studies in patients undergoing implantation of a left ventricular assist device
or other cardiac surgery [13]. Some other examples of wireless implants for cardiac monitoring are
related to smart stents equipped with microscale sensors [14,15].
All these implantable HF monitoring systems currently under development rely on hemodynamic
(pressure) sensors that may have reliability problems in the long-term since the fibrous tissue
encapsulation may interfere with the correct operation of the deformable diaphragms or
pressure-sensitive surfaces they use.
Monitoring cardiac kinematics rather than hemodynamics holds the premise for early detection of
impairment in cardiac function that may predict decompensation in HF patients and prevent recurrent
hospitalizations by tailoring an effective drug therapy. Cardiac kinematics can be detected using
implantable inertial sensors like gyroscopes and accelerometers. Some researchers have proposed and
evaluated the use of miniaturized accelerometers to monitor cardiac function and automatically detect
ischemic events by measuring linear displacements in the 3D space [16,17]. However, one of their
major concerns is that accelerometers cannot differentiate between acceleration due to motion and
acceleration due to gravity, therefore gravity filtering is essential for an accurate motion calculation.
Our research group proposed, for the first time, the use of a gyro sensor, based on Coriolis force, to
quantify cardiac apex rotation [18]. Our previous in vivo animal experience was mainly focused on the
use of a single-axis (1D) gyro sensor positioned at the epicardial site to detect cardiac rotation during
both the normal heart functioning and the experimentally-induced, altered cardiac conditions [19–23].
In this paper, we present the CardioMon, a novel, implantable, sensorized lead equipped with
a tri-axis MEMS gyro sensor (3D gyro), intended to continuously monitor cardiac rotation both at
epicardial and endocardial sites. Here, we describe the first prototypal assembly of the CardioMon
lead and we report the results of preliminary lab tests performed to assess the reliability of the 3D
gyro readings.

2. Materials and Methods

2.1. The Conceptual Design

The conceptual design of the novel CardioMon device for continuous monitoring of cardiac apex
rotation is depicted in the scheme of Figure 1. An implantable lead including a 3D gyro and associated
ASIC is coupled to a coil antenna, placed in a pacemaker-like case, and positioned subpectorally.
The implanted gyro sensor can be powered and interrogated from outside by transcutaneous energy
transfer (TET) between the subpectorally implanted coil and the external antenna included in a reading
unit held against the patient.
Sensors
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EXTERNAL UNIT:
•EXTERNAL
poweringUNIT:
coil •• reading/processing
powering
antenna CPU
coil • reading/processing
antenna CPU
Rotation data coil
Rotation data coil
TET
TET

ASIC
ASIC

3D gyro
3D gyro

Figure 1. Scheme of conceptual design of the CardioMon lead system for continuous monitoring of
Figure 1. Scheme of conceptual design of the CardioMon lead system for continuous monitoring of
Figure apex
cardiac 1. Scheme of conceptual design of the CardioMon lead system for continuous monitoring of
rotation.
cardiac apex rotation.
cardiac apex rotation.
2.2.
2.2.CardioMon
CardioMonLead LeadAssembly
Assembly
2.2. CardioMon Lead Assembly
The
TheCardioMon
CardioMonlead leadcomprises
comprisesaasensorized
sensorizedtip tipand
andaaflexible
flexiblemain
mainbody body(standard
(standardsilicone
siliconesheath
sheath
used The
for CardioMon
implantable lead
cardiac comprises
leads), a sensorized
including the tip and
electrical a flexible main
connections
used for implantable cardiac leads), including the electrical connections (4 insulated wires) (4body (standard
insulated wires)silicone
requiredsheath
for
required
used
the for
forsensor implantable
the sensor (Figure(Figure cardiac
2). The leads),
2). sensorized including
The sensorized tip istip the
formed electrical
is formed connections
by a Delrin capsule
by a Delrin (4 insulated
(Ø = 4.4
capsule (Ø = mm, wires)
4.4 L = 6.6
mm, required
L mm)
= 6.6 thatfor
mm)
the
thatsensor
provides
provides (Figure
a capacitive 2). 3D
a capacitive TheMEMSsensorized
3D MEMS tip
gyro gyro issensor
sensor formed by a Delrin
(CMR3100-D01,
(CMR3100-D01, capsule
Murata (Ø Electronics
= 4.4 mm,
Electronics
Murata L = Kyoto,
Oy, Oy, 6.6 Japan)
Kyoto, mm) that
of
Japan)
provides
very small a capacitive
size (3.0 mm 3D × MEMS
3.0 mm gyro
× 0.9sensor
mm). (CMR3100-D01,
It is equipped Murata
with
of very small size (3.0 mm × 3.0 mm × 0.9 mm). It is equipped with a detection range of ±500 /s a Electronics
detection rangeOy, ofKyoto,
±500 Japan)
°/s and◦ of
a
very
digital small
and a SPI/I2C size (3.0 mm ×
interfaceinterface
digital SPI/I2C 3.0
for outputmm × 0.9
forreading, mm). It is equipped
a miniaturized
output reading, with a detection
printed circuit
a miniaturized printed board range
(PCB),
circuit of
board ±500
and(PCB),°/s and
and aa
a titanium
digital
screw toSPI/I2C
titanium allow
screwitsinterface
tosecure for
its output
allowanchoringsecure to reading, a to
miniaturized
the endocardium.
anchoring Theprinted
the endocardium. circuit
capsuleThe
is also board
equipped
capsule is(PCB),
alsowithand a titanium
a removable
equipped with a
screw
silicone to
removable allow
flange its
silicone secure
with two flange anchoring
holeswithto two to
allow the endocardium.
it to to
holes beallow
sutured The
tobe
it to capsule
thesutured is
epicardial also
to thesites equipped
(Figure 2a).
epicardial with a removable
sites (Figure 2a).
silicone flange with two holes to allow it to be sutured to the epicardial sites (Figure 2a).
removable
a titanium screw
silicone flange
removable
a titanium screw
silicone flange

(a)
(a)
Figure 2. Cont.
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3D Gyro (3.0 x 3.0 x 0.9 mm)

3D Gyro (3.0 x 3.0 x 0.9 mm)

6.6 mm
4.4 mm 6.6 mm
4.4 mm

PCB
PCB
lead
lead
Sensorized
Sensorized
capsule in the tip
capsule in the tip

(b)
(b)
Figure 2.2.The
Figure2.
Figure TheCardioMon
CardioMon lead:
CardioMon (a) 3D
lead: (a) rendering of
3D rendering of the
the CardioMon
CardioMon leaddesign;
CardioMonlead design; (b)picture
design;(b) picture
pictureofof the
ofthethe
assembled
assembled CardioMon
CardioMon prototype.
prototype.
assembled CardioMon prototype.

2.3. Data Reading Unit

2.3.
2.3.Data
DataReading
ReadingUnit
Unit
We
We assembled a data reading unit to implement the I2Cthe
digital communication protocol required
We assembled
assembled aa data
data reading unit to to implement
implement I2C digital
the I2C digitalcommunication
communication protocol
protocol
for the
requiredoutput reading of the 3D gyro included in the CardioMon lead. The reading unit comprises a
requiredfor
forthe
the output
output reading
reading of the 3D gyrogyro included
included ininthe
theCardioMon
CardioMonlead. lead.The Thereading
readingunitunit
microcontroller
comprises board (Arduino Mega
comprisesaamicrocontroller
ADK 5 V/16
microcontroller board (Arduino Mega MHz,
(Arduino Mega ADK5Arduino,
ADK 5 V/16
V/16MHz, Italy),
MHz, three power
Arduino,
Arduino, Italy),adapters,
Italy), threepower
three
and
power
three Digital/Analog
adapters,and
adapters, andthree (D/A) converters,
threeDigital/Analog one for each
Digital/Analog (D/A) converters, sensitive
converters,oneonefor axis
foreach of the
eachsensitive3D gyro
sensitiveaxis (Figure
axisofofthe
the3D 3).
3DgyroThe
gyro analog
(Figure
(Figure
output
3). signals
The analogfrom the
output reading
signals
3). The analog output signals unit
from have
the reading unit have been collected and analyzed usingsystem
been
reading collected
unit and
have analyzed
been using
collected and a data
analyzed acquisition
using a adata
data
for biomedical
acquisition signals
acquisitionsystem
systemfor (MP100, Biopac
for biomedical System,
biomedical signals (MP100, Goleta,
(MP100, BiopacCA, USA).
BiopacSystem,
System,Goleta,
Goleta,CA,
CA,USA).
USA).

D/A converters
D/A converters

Power Arduino ADK 3D

Power Arduino ADK 3D
MEMs Arduino
D/A
D/A
Data
Power converters Data
adapter MEMs
Gyro Power
adapter
Arduino
ADK converters
Acquisition
adapter Gyro adapter ADK
Acquisition
Unit
Unit

a) b)
a) b)
Figure 3. (a) Picture and block diagram of (b) the data reading unit developed for the output reading
Figure 3. (a) Picture and block diagram of (b) the data reading unit developed for the output reading
Figure
of 3. gyro
the 3D (a) Picture andinblock
included diagram of lead.
the CardioMon (b) the data reading unit developed for the output reading
of the 3D gyro included in the CardioMon lead.
of the 3D gyro included in the CardioMon lead.
2.4. Functional Lab Tests
2.4. Functional Lab Tests
2.4. Functional
FunctionalLab
labTests
tests were performed with the assembled CardioMon lead to assess the reliability
Functional lab tests were performed with the assembled CardioMon lead to assess the reliability
of theFunctional
3D gyro readings
lab testswhen
were it was encapsulated in the tip ofCardioMon
an implantable lead.
of the 3D gyro readings whenperformed with the assembled
it was encapsulated leadlead.
in the tip of an implantable to assess the reliability
of the 3D gyro readings when it was encapsulated in the tip of an implantable lead.
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We developed
We developed aa mechanical simulator of
mechanical simulator of rotational
rotational movements
movements within within the the range
range of of cardiac
cardiac
rotations to be used for the tests. The simulator was composed
rotations to be used for the tests. The simulator was composed of a DC brush motor (Escap 17N78- of a DC brush motor
(Escap 17N78-210E-F16,
210E-F16, Portescap, West Portescap,
Chester,West Chester,
PA, USA), PA, USA),by
controlled controlled
a programmable by a programmable
automationautomation
controller
(CompactRIO, National Instruments, Austin, TX, USA) and operated by a graphic user interface user
controller (CompactRIO, National Instruments, Austin, TX, USA) and operated by a graphic that
interface
we that weindeveloped
developed LabVIEWin(National
LabVIEW Instruments,
(National Instruments,
Austin, TX, Austin, USA).TX, A USA). A supporting
supporting boardboard was
was anchored
anchored to theto rotating
the rotatingshaftshaft of the
of the motor
motor and,and, rotating
rotating with
with it,it,it itwas
wasused
usedtotoposition
positionthe the sensors
sensors
to be tested (Figure
to be tested (Figure 4). 4).
An “off-the-shelf”
An “off-the-shelf”single-axis
single-axisgyro gyro sensor
sensor (1D (1D
gyro)gyro)
with withanaloganalog outputoutput(XV-3500CB,(XV-3500CB,
Epson
Epson Toyocom, Tokyo, Japan) that we had previously evaluated
Toyocom, Tokyo, Japan) that we had previously evaluated in sheep [21] was used as a reference in sheep [21] was used as a reference
sensor in
sensor in the
the tests.
tests.
Both the
Both the CardioMon
CardioMon lead lead including
including the the 3D
3D gyro
gyro and
and thethe analog
analog 1D 1D gyro
gyro werewere mounted
mounted on on the
the
supporting board and fixed in stable position by means of adjustable
supporting board and fixed in stable position by means of adjustable clips attached to the board clips attached to the board
(Figure 4).
(Figure 4).
The simulator
The simulator was was programmed
programmed to to provide
provide target
target angular
angular velocities
velocities (V (VTT)) in
in both
both clockwise
clockwise (+) (+)
and counterclockwise ( − ) directions (V = +200 ◦ /s and V = − 100 ◦ /s, respectively) that, according
and counterclockwise (−) directions (VT+ T+= +200 °/s and VT−T=− −100 °/s, respectively) that, according to
to literature
literature data,
data, can can
bebe considered
considered representativeofofcardiac
representative cardiactwisting
twistingvelocities
velocities (i.e., 200◦°/s
(i.e., 200 /s inin the
the case
case
of a tachycardia condition and 100 ◦ /s in the case of sinus rhythm).
of a tachycardia condition and 100 °/s in the case of sinus rhythm).
For the
For the tests,
tests, the
the CardioMon
CardioMon lead lead was
was fixed
fixed onon the
the supporting
supporting board board of of the
the simulator
simulator in in order
order
to evaluate
to evaluate the the response
response of of each
each single-axis
single-axis of of the
the 3D3D gyro
gyro (Figure
(Figure 4). The detecting
4). The detecting axis axis ofof the
the 3D
3D
gyro in the tip of the CardioMon lead was aligned with the rotating shaft
gyro in the tip of the CardioMon lead was aligned with the rotating shaft of the motor (“X alignment”, of the motor (“X alignment”,
“Y
“Y alignment”,
alignment”, and and “Z “Z alignment”,
alignment”, respectively)
respectively) forfor each
each test while the
test while the 1D1D gyro
gyro remained
remained in in the
the same
same
position, i.e.,
position, i.e., with
with thethe only
only oneone sensitive
sensitive axisaxis parallel
parallel toto the
the shaft.
shaft.
For each
For each alignment
alignment of of the
the CardioMon
CardioMon lead, lead, five
five repetitions
repetitions of of thethe following sequence
following sequence
V00/V
V /VT+T+
/V/V
T−/V /V0 (with
0 (with
T− V0 =motion)
V0 = stop stop motion) were carried
were carried out andout the and
angular the velocity
angular signals
velocitywere signals were
collected
collected from the two gyro
from the two gyro sensors simultaneously. sensors simultaneously.

3D gyro Z
Rotation simulator CardioMon Y
1D gyro
(3D gyro)
X
X alignment

rotating Z
shaft Supporting
board Y
I2C Reading Unit X Y alignment

Y
Z

X Z alignment

Figure 4.
Figure The mechanical
4. The mechanical simulator
simulator with
with the
the two
two mounted
mounted gyro
gyro sensors.
sensors.

2.5. Data Analysis and Statistics

2.5. Data Analysis and Statistics
For each alignment of the CardioMon lead, the three components of the angular velocities detected
For each alignment of the CardioMon lead, the three components of the angular velocities
by each sensitive axis (V3DX , V3DY , and V3DZ ) were collected and the modulus of angular velocity (V3D ),
detected by each sensitive axis (V3DX, V3DY, and V3DZ) were collected and the modulus of angular
representing the main direction of the angular velocity, was calculated as in the following equation.
velocity (V3D), representing the main direction of the angular velocity, was calculated as in the
following equation. q
V3D = V23DX + V23DY + V23DZ (1)
2 2 2 (1)
𝐕𝟑𝐃 = √V3DX + V3DY + V3DZ
For the 1D gyro, the single-axis velocity (V1D ) was recorded. V3DX , V3DY , V3DZ , and V1D were
considered
For theto1D gyro, ±
be mean theSDsingle-axis
and were obtained
velocity by averaging
(V1D five repetitions
) was recorded. V3DX, Vof3DYthe test, and
, V3DZ sequence with
V1D were
considered to be mean ± SD and were obtained by averaging five repetitions of the test sequence with
Sensors 2018, 18, x 6 of 10
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the angular velocity signals detected over the period in which the simulator maintained the set target
velocities
the angular(Vvelocity
T+ and VT−).
signals detected over the period in which the simulator maintained the set target
Noise(Vlevel
velocities T+
was
and V estimated for both the 3D gyro (N3D) and 1D gyro (N1D) as the peak-to-peak
T− ).
angular velocity signal
Noise level was estimatedat the Vfor
0 condition (Figure 5). For the 3D gyro, N3D was identified as the
both the 3D gyro (N3D ) and 1D gyro (N1D ) as the peak-to-peak
maximum noise level among those
angular velocity signal at the V0 condition detected(Figure
for each5).sensitive
For the axis (N3DXN
3D gyro, ,N 3DY, and N3DZ). The N3D
3D was identified as the
was estimated
maximum noisefor eachamong
level X, Y, Zthose
alignment.
detected for each sensitive axis (N3DX , N3DY , and N3DZ ). The N3D
Measurement errors (E) were
was estimated for each X, Y, Z alignment. calculated for both the 3D gyro (E3D) and the 1D gyro (E1D) as the
difference
Measurement errors (E) were calculated for bothand
between the measured angular velocities the the
3D target
gyro (Evelocities, by averaging for each
3D ) and the 1D gyro (E1D ) as the
X, Y, Z alignment
difference betweenthe theerrors obtained
measured for clockwise
angular velocities and
and counterclockwise
the target velocities,directions.
by averaging for each X,
For comparative evaluations between the 3D gyro (V 3D) and the 1D gyro (V1D) recordings, the
Y, Z alignment the errors obtained for clockwise and counterclockwise directions.
Student’s t-test was used.
For comparative All analyses
evaluations were made
between the 3Dwith SPSS
gyro (VVersion 23.0 (IBM SPSS, New York, NY,
3D ) and the 1D gyro (V1D ) recordings,
USA) and a p value of 0.05 was chosen as significant.
the Student’s t-test was used. All analyses were made with SPSS Version 23.0 (IBM SPSS, New York,
NY, USA) and a p value of 0.05 was chosen as significant.
3. Results
3. Results
Results from the preliminary in vitro tests showed that the CardioMon lead was well-designed
and well-assembled,
Results from theaspreliminary
well as provided
in vitroaccurate detections
tests showed of angular
that the CardioMonvelocities
lead within the range of
was well-designed
cardiac twisting velocities.
and well-assembled, After
as well solving initial
as provided crosstalk
accurate problems
detections relatedvelocities
of angular to the arrangement
within the of the
range
4ofwires
cardiac twisting velocities. After solving initial crosstalk problems related to the arrangementtip
inside the lead, the angular velocity readings from the 3D gyro included in the sensorized of
were reliable
the 4 wires andthe
inside comparable with detections
lead, the angular from the
velocity readings from“off-the
the 3D shelf” 1D gyro.
gyro included Both
in the were in
sensorized
accordance with and
tip were reliable the comparable
simulated target velocities (Figure
with detections from the4).“off-the
For each X, Y,
shelf” 1D Zgyro.
alignment of the
Both were in
CardioMon lead, the differences between the mean value of V and the corresponding mean
accordance with the simulated target velocities (Figure 4). For each X, Y, Z alignment of the CardioMon
3D value
of V1Dthe
lead, were not statistically
differences between significant for either
the mean value of V3Dclockwise or counterclockwise
and the corresponding target
mean value velocities
of V 1D were
(Table 1).
not statistically significant for either clockwise or counterclockwise target velocities (Table 1).

Figure 5. Angular
Figure 5. Angular velocity
velocity signals
signals recorded
recorded with
with 1D gyro (V
1D gyro (V1D
1D in
in red
red line)
line) and
and with
with 3D
3D gyro (three
gyro (three
components: V , V , and V in blue gradations) during each X, Y, Z alignment; N
components: V3DX , V3DY , and V3DZ in blue gradations) during each X, Y, Z alignment; N1D = estimated
3DX 3DY 3DZ 1D = estimated
noise for 1D
noise for 1D gyro;
gyro; N N3DX
3DX,, N
3DY, ,and
N3DY andN 3DZ= =
N3DZ estimated
estimatednoises
noisesfor
foreach
eachdetecting
detectingaxis,
axis,used
used to
to obtain
obtain the
the
noise level for 3D gyro (N3D 3D).
).

Comparison
Table between
1. Results of t-testthe modulus
analysis usedofforangular velocities
comparative detected
evaluations by the 3D
between 3D gyro
gyro(V(V3D3D ) for1D
) and each X,
Y, Z alignment and the single-axis
gyro (V1D) recordings. angular
p value < 0.05 velocity
indicates measured
statistically fromdifferences.
significant the 1D gyro are also reported in
Figure 6.
VT [°/s] V3D [°/s] V1D [°/s] p
When comparing the 3D gyro recordings with the target velocities programmed for the tests (VT+
|VT+| = 200 201 ± 4 205 ± 3 0.218
and VT− ), we found that,X-alig
for each|V X,T−Y, Z alignment,
| = 100 104 ± 3
the measurement
101 ± 3
errors (E3D ) were below the
0.065
corresponding estimated noise level (N
|VT+| =3D ),
200 as well as
201 ± 8 the measurement
207 ± 2 error for the 1D gyro (E1D )
0.274
Y-alig
being below the corresponding noise |VT−level (N1D ) 104
| = 100 (Table
± 2 2). 98 ± 5 0.071
Sensors 2018, 18, x 7 of 10
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|VT+| = 200 199 ± 2 203 ± 4 0.140
Z-alig
|VT−| = 100 99 ± 3 104 ± 3 0.171
Table 1. Results of t-test analysis used for comparative evaluations between 3D gyro (V3D ) and 1D
Comparison betweenp the
gyro (V1D ) recordings. value < 0.05 indicates
modulus statistically
of angular significant
velocities detecteddifferences.
by the 3D gyro (V3D) for each
X, Y, Z alignment and the single-axis
VT angular
[◦ /s] velocity
V3D [◦measured
/s] V1D [from
◦ /s] the p
1D gyro are also reported
in Figure 6.
|VT+ | = 200 201 ± 4 205 ± 3 0.218
When comparing the 3D gyro recordings with the target velocities programmed for the tests (VT+
X-alig
|VT− | = 100 104 ± 3 101 ± 3 0.065
and VT−), we found that, for each X, Y, Z alignment, the measurement errors (E3D) were below the
|V | = 200 201 ± 8 207 ± 2 0.274
corresponding estimated noise level (N3D), as well as the measurement error for the 1D gyro (E1D)
T+
Y-alig
being below the corresponding noise
|VT−level
| = 100(N1D) (Table
104 ± 22). 98 ± 5 0.071
|VT+ | = 200 199 ± 2 203 ± 4 0.140
Z-alig signals, noises, and errors provided by the 3D gyro included in the
Table 2. Angular velocity
|VT− | = 100 99 ± 3 104 ± 3 0.171
CardioMon lead and in reference to the 1D gyro.

Table 2. Angular Target

velocity signals, 3D MEMS
noises, andGyro
errors provided by the 1D3D
Gyro
gyro included in the
CardioMon lead and VTin[°/s] V3Dto[°/s]
reference the 1DE3D [°/s] N3D [°/s] V1D [°/s] E1D [°/s] N1D [°/s]
gyro.
V0 = 0 7±1 8±1
X-alig Target
|VT+| = 200 201 ±3D 4 MEMS Gyro 205 ± 3 1D Gyro
◦ /s] ◦ /s] 4±2 4±3 ◦
VT [|V T−| = 100 V3D [104 ± 3 E3D [◦ /s] N3D [◦ /s] 101 ± 3[◦ /s]
V1D E1D [ /s] N1D [◦ /s]
V0 = 0V0 = 0 77 ±±11 8±1 8±1
X-alig Y-alig
|VT+ ||V= T+
200 ±4±8
| = 200201 201 207205
± 2±3
4 5±±2 4 4±3
|VT− | = 100 104 ± 3 101 ± 3 6 ± 3
|VT−| = 100 104 ± 2 98 ± 5
V0 = 0V0 = 0 77 ±±01 10 ± 2 8 ± 1
Y-alig |VT+ | = 200 201 ± 8 207 ± 2
Z-alig |VT+| = 200104 199
|VT− | = 100 ±2
±2 5 ± 4 20398± ±
4 5 6 ± 3
2±1 4±3
|VT−| = 100 99 ± 3 104 ± 3
V0 = 0 7±0 10 ± 2
X, Z-alig
Y, Z-alig. |V
= alignment
T+ | = 200
of x,199
y or
± 2z-axis of the 3D gyro parallel to 203 the ±rotating
4 shaft of the simulator;
2±1 4±3
V0 = no motion|VT−of | =the 99 ± 3VT = target angular velocities; V
100simulator; 3D ±
104 = modulus
3 of angular velocity
measured
X, Y, Z-alig.by
= the 3D gyro;
alignment V1D
of x, = single-axis
y or z-axis of theangular
3D gyrovelocity forthe
parallel to the 1D gyro;
rotating E3D
shaft of=the
calculated
simulator;error
V0 =for
no
motion
the 3D of the simulator;
gyro; VT = target
E1D = calculated angular
error velocities;
for the 1D gyro;V3D N
= 3D
modulus of angular
= estimated noisevelocity measured
for the by the
3D gyro; N1D3D=
gyro; V1D = single-axis angular velocity for the 1D gyro; E3D = calculated error for the 3D gyro; E1D = calculated
estimated noise for the 1D gyro. All variables are reported as mean values obtained by averaging
error for the 1D gyro; N3D = estimated noise for the 3D gyro; N1D = estimated noise for the 1D gyro. All variables the
data of five as
are reported test repetitions.
mean values obtained by averaging the data of five test repetitions.

220

200
V1D
V1D+
V3Di+
V 3D
180
Angular Velocity (°/sec)

160

140

120

100

80
X-alignment
1 Y-alignment
2 Z-alignment
3

Figure 6. Comparison between the modulus of angular velocities from 3D gyro (V3D , in blue line)
detected6.for
Figure each X, Y, Zbetween
Comparison alignment
theand the single-axis
modulus angular
of angular velocity
velocities from
from 3D1D gyro(V(V
gyro , inblue
, in
3D1D red line)
line).
Values were ± SD from ◦ /s; |V | = 100◦ /s.
detected for reported
each X, Y,asZmean
alignment fivesingle-axis
and the test repetitions. |VT+
angular | = 200from
velocity 1DT−gyro (V1D, in red
line). Values were reported as mean ± SD from five test repetitions. |VT+| = 200 °/s; |VT−| = 100 °/s.
Sensors 2018, 18, 4195 8 of 10

4. Discussion
In this study, we present CardioMon, an innovative implantable lead including a miniature 3D
MEMS gyro sensor to detect cardiac rotation.
Gyro sensors can provide a direct measurement of cardiac mechanics and may potentially offer
more long-term reliability than pressure sensors because they can operate inside a rigid hermetic
capsule without being affected by the growth of fibrous tissue that occurs in the harsh environment
of human body after implantation. Moreover, with gyro sensors the angular displacement signal is
directly obtained by a single integration of the measured angular velocity; it is less affected by bias or
noise artifacts than the linear displacement obtained by the double integration of accelerometer signals.
The study results demonstrated that integration of a 3D MEMS gyro into a transvenous lead
for cardiac implantable electronic devices (CIEDs) is feasible and reliable, particularly since 3D gyro
measurements were in accordance with 1D gyro recordings and target velocities. If compared with a
1D gyro, a 3D gyro has the advantage that in the case of future clinical implantation, it could be placed
at an arbitrary orientation rather than requiring the alignment of the only sensitive axis, parallel to the
cardiac axis, to be confident of maximum signal detection.
In this study, we reported preliminary in vitro evaluations of the new implantable CardioMon
lead, tested using a mechanical simulator of cardiac rotational movements. Additional lab tests will be
conducted using an upgraded mechanical simulator that we recently designed, which is capable of
reproducing all three components of cardiac motion (longitudinal, radial, and rotational) combined
into synchronous movements [24].
Animal experiments will also be planned to further evaluate the CardioMon lead in an in vivo
environment and to explore different implantation sites for the sensorized lead within the heart.
The in vivo results will be compared to outcomes provided by a computational finite element model
of cardiac torsion that we developed previously [25].

5. Future Perspective for CardioMon Implantation in Humans

In the current prototype of the CardioMon lead, the dimensions of the sensorized capsule are
suitable for experimental evaluations in animals (sheep model) but further miniaturization will be
necessary before implantation in humans. Future efforts will be in an attempt to assemble a CardioMon
lead with a smaller sensorized capsule on the tip, including a gyro sensor smaller than the current one,
e.g., the BMG250 ultra-small three-axis angular rate sensor (Bosch Sensortec GmbH, Kusterdingen,
Germany). This is, to our knowledge, the smallest (3 mm × 2.5 mm × 0.83 mm) 3D gyro currently
available on the market.
In addressing the future of CardioMon implantation in humans, different options could be
explored for exploiting the potential of this novel implantable sensor system. These include the possible
CardioMon integration with active implantable therapeutic cardiac devices, such as implantable
cardioverter defibrillators (ICDs), or devices for cardiac resynchronization therapy (CRTs), as well as
its development as a stand-alone monitoring system.
Following the first hypothesis, the CardioMon system would increase the potential of CIEDs by
combining therapy delivery with a continuous monitoring feature, which can also be used to enhance
the automatic optimization of the device-delivered therapy itself. The integration of CardioMon in an
ICD or a CRT device would not increase power requirements since the implantable gyro sensor can be
powered using batteries already used for ICDs or CRT devices.
Stand-alone implantable monitors represent a recent way of approaching the treatment of HF by
adding value to the monitoring of symptoms and daily weight alone. An example of a lead-based
solution for CardioMon implantable system is the one we previously depicted in Figure 1.
A leadless solution could also be pursued for the stand-alone CardioMon system. In this
case, following the example of other implantable HF monitoring systems under development [10],
the implanted gyro sensor with advanced ASIC would be included in a miniature leadless capsule to
be delivered and fixed endocardially at the level of the right ventricular apex (Figure 7). The system
Sensors 2018, 18, 4195 9 of 10
Sensors 2018, 18, x 9 of 10

would require no leads

would require or batteries
no leads andand
or batteries would
wouldbebeconcurrently powered
concurrently powered andand interrogated
interrogated via anvia an
external antenna, similarsimilar
external antenna, to thetoalready developed
the already developedCardioMEMS
CardioMEMS PAP PAPsensor
sensor
[7].[7].

EXTERNAL UNIT:
• powering
• reading/processing
CPU

TET Coils

Rotation data

4.4
ASIC
mm

Implanted capsule 6.6 mm

3D gyro
(«leadless» solution)
Scheme
Figure 7.Figure of a possible leadless CardioMon solution designed as a stand-alone implantable
7. Scheme of a possible leadless CardioMon solution designed as a stand-alone implantable
cardiac monitor.
cardiac monitor.

Author Contributions:
Author Contributions: Conceptualization,
Conceptualization, E.M.
E.M. andL.C.;
and L.C.; Data
Data curation,
curation, L.C.; Methodology,
L.C.; E.M. and
Methodology, E.M.L.C.;
and L.C.;
Writing—original draft, E.M.; Writing—review & editing, L.C.
Writing – original draft, E.M.; Writing – review & editing, L.C.
This research
Funding: Funding: received no external funding.
This research received no external funding
Conflicts Conflicts
of Interest: The authors declare no conflict of interest.
of Interest: The authors declare no conflicts of interest.

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