Medizinfcchnik in der Kardiologie

TRACKABILITY, CROSSABILITY, AND PUSHABILITY OF CORONARY

STENT SYSTEMS - AN EXPERIMENTAL APPROACH
W. Schmidt1, N. Grabow2, P. Behrens1, K.-P. Schmitz1
Institute for Biomedical Engineering, University of Rostock, Germany
2
Institute for ImplantTechnology and Biomaterials, Rostock-Warnemünde, Germany

wollram.schmidt@medizin.uni-rostock.de

Abstract— Trackability, crossability and pushability are Material and methods

essenlial properties dctermining the handling charac-
leristics and deliverability of stent Systems. We present
objeclive test methods to assess these parameters quan-
lifativelv in an in vitro model.
The model consisted of a 6F guiding catheter, a guide
wire (0.014") and a coronary vessel model (HD-PE
tubing, I.D. 2.5 mm), all immersed in 37°C water. Two
attached sensors measured the reactive forces occurring
at the proximal catheter shaft and the distal catheter
and stent segments during model passage. For
crossability assessment, the setup was completed by a
Stenosis model. mimicking two types of eccentric circu-
lar stenoses.
A comparative study provided distinctive differences in
trackability, Stenosis crossability, and pushability.
Analyzing the proximal and distal force measurements,
these differences were quantified and the qualification
of a particular stent System to be successfully delivered
to a model target Stenosis could be rated.
Keywords— Stent Systems, Trackability, Crossability,
Pushability, In-vitro testing
Introduction
A selection of five commercially available coronary
stent Systems from five different manufacturers was
comparatively analyzed.
The measurement arrangement, described previously
[1,2] was modified to obtain more detailed results. The
in vitro model consisted of a 6 F guiding catheter, a
guide wire (0.014") and a coronary vessel model (HD-
PE tubing, I.D. 2.5 mm), all immersed in 37°C water
(Figure 1). The proximal catheter shaft of each exam-
ined stent System was mounted on a linear drive unit
and then maneuvered through the model at a constant
proximal speed of 7.5 mm/s. An attached sensor meas-
ured reactive forces occurring at the proximal catheter
shaft äs well äs at the Stenosis model during model
passage.
stent systerrr\ r proximal force sensor
\s distal force sensor
< A$> with Stenosis model /- gukfing catheter
j \/Q
,<·!'! /·' J
V^''· _ "-- - coronary vessel model 1
water bath(3rc>

Trackability, crossability and pushability are essential linear drive unit7

properties determining the handling characteristics and Figure 1: Schematic diagram of the measurement
deliverability of coronary stent Systems. Due to the setup. The setup is adapted to the parameter to be
general high Standard of modern stent Systems and cur- measured in terms of the changeable vessel model.
rent techniques for stent application, i.e. direct stenting,
these properties are of growing interest.
The trackability was measured using the curvature of
The trackability of a stent System describes its perform-
the distal part of a JL3.5 guiding catheter and a HD-PE
ance to be tracked through the curved vessel System up
tubing configuration simulating a curved vessel geome-
to the lesion to be treated in the coronary artery. Thus
try. For the trackability parameter the proximal force
the trackability is a combined property, which is mainly
was measured äs a function of the stent Systems position
determined by the stiffness and the profile of the stent
while moving through the model. As the result a force-
System, and friction effects between the stent System
distance curve was obtained for further analysis.
and the guiding catheter and guide wire, which are
To assess the crossing behavior of the stent Systems, the
commonly used. The pushability parameter describes
described in vitro setup was completed by a Stenosis
the possibility to transmit a proximal push force to the
model (Figure 2), placed at the end of the coronary
distal part of the stent System and the crossability de-
vessel model. The Stenosis model was fabricated from
scribes the ability of the distal part of the stent System to
solid PMMA and featured a conic luminal narrowing
pass through a narrowed vessel lesion. All these pa-
from 2.5 mm to l .5 mm. Thus, the cross sectional and
rameters define essentially the quality of a stent System.
diameter occlusion amounted to 64% and 40%, respec-
For a better understanding of the acting processes they
tively. With this model, two types of eccentric circular
should be assessed separately.
stenoses were simulated: Type l in the inner radius and
This study presents objective test methods to assess
Type 2 in the outer radius of a coronary bend.
theses parameters quantitatively in an in vitro model.

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 Medizintechnik in der Kardiologie

frontal view of Stenosis Type 1 and Type 2

force sensor with thrust piece ~ Position of cath. tip

B: end Position of cath.
coronary vessel model d=33mm
(HP-PE,I.D.2.5mm)

force sensor with Stenosis modeK

Ajstert Position of cath. t
coronary vessel
(HP-PE,I.D.2.5mm)

guiding catheterSF
d=33mm

guiding catheter6F
d=33mm
Figure 2: Model mimicking two types of Stenosis at
the end of a curved vessel path
The Stenosis model was fit to a second sensor to meas-
ure the reactive forces occuning at the Stenosis during
passage of distal catheter and stent segments. Force
plots of distal and proximal reactive forces were re-
corded for each stent System and crossability was de-
termined äs the mean distal force during passage of the
Stenosis model. For each stent system the results from
three subsequent trials were averaged.
The pushability of the examined stent Systems was
determined äs the force ratio of the distal and proximal
reactive force while pushing the stent Systems against a
totally occluded vessel model (Figure 3). For this pur-
pose the Stenosis model was removed and a thrust piece
mounted on a force sensor was attached to the end of
the coronary vessel model.
Figure 3: Stenosis model for the pushability test. The
vessel is simulated äs totally occluded.
The stent Systems were placed in the setup and then
pushed against the distal thrust piece until a proximal
force of 3.5 N was measured. Due to the potential of
stent system damage, only one trial per sample was
performed.
Results
All examined stent Systems passed the vessel and Steno-
sis model without damage and reproducible results in
the force measurements were achieved. Furthermore, it
was found that distinctive differences in Stenosis
crossability, äs well äs pushability, can be detected
among the investigated coronary stent Systems.
The force-distance curves of the trackability test are
shown in Figure 4 averaged for 3 measurements for
each stent System.

Guidant RX Muttilink Penta 3.0x15

0.9
Biotronik Lekton 3.0x15
Boston Sdentific Express 3.0x16
0.6
Cordis Velocity 3.0x18
Medtronic AVE S670 3.0x15

200
• [mm]

Figure 4: Force-distance curves of trackability measurements (averaged over 3 measurements for each stenl
system)

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Jß ^_ _____

0 14
Guidant MulUHnk Ponte 3 0x1$
0 12 Cortlln Voloclty 3 Ox 1 ss
— Danton Sei ExproA· 3 0x1 —

01 , Medtronic AVE S670 3 0x16

— Hlotronlk Lok ton 3 0x15—i

008

000

002

10 20 30 40 50 60
s [mm]
Pigure 5: Force distance curve of the distal reactive forces for each stent System whilst passing the Stenosis
model (type 2)
The Systems crossability is represented by the force-
distance curves of the proximal and distal reaction Discussion
forces (Figure 5) where the mean distal force is taken äs Employing proximal and distal force measurements, the
the value for the crossability parameter (Figure 6). differences concerning the related parameters trackabil-
ity, crossability and pushability could be quantified and
the qualification of a particular stent System to be suc-
cessfiilly delivered to a model target Stenosis could be
rated.
Concerning the trackability parameter it can be stated
that low track forces are necessary to reach the lesion to
be treated. It is assumed that the trackability is quite
independent from the crossability but influenced among
others by the pushability of a delivery System. The best
pushability and trackability results were found at the
Stenosis Type 1 Stenosis Type 2 AVE S670 stent System. For good crossability a small
DD Biotronik Lekton 3.0x15
Q Medtronic AVE S670 3.0x15
O Boston Sei. Express 3.0x16
D Cordis Velocity 3.0x18
profile of the distal part is an advantage, äs can be seen
Guidant Multlink Penta 3.0x15 with the Lekton or Express stent Systems.
This study showed that the presented in vitro test
Figure 6: Mean distal forces äs the parameter for
method for coronary stent Systems can provide a valu-
systenTs crossability able tool to assess their crossability and pushability
characteristics. Moreover, it relates closely to the appli-
cation of coronary stent Systems, thereby leading to
meaningful results in prototype and product testing. For
the Interventionist, results from this test method may
help to choose the appropriate stent System for a par-
ticular lesion in terms of an adequate deliverability and
in terms of a suitability for direct stenting.

« Medtronic AVE S670 3.0x15 O Guidant Multilink Penta 3.0x15

01 Biotronik Lekton 3.0x15 0 Boston Sdentific Express 3.0x16 References
0 Cordis Velocity 3.0x18
[1] K.-P. Schmitz, W. Schmidt, P. Behrens, D. Behrend,
Figure 7: Pushability of the stent Systems investi- D. Lootz, B. Graf: „In vitro examination of clini-
gated cally relevant stent parameters", Progress in Bio-
med. Res.9 vol. 5, pp. 197-203, 2000
The pushability results are given by the ratio of distal to [2] K.-P. Schmitz; P. Behrens, W. Schmidt, D. Behrend,
proximal reactive forces, measured from the Systems W. Urbaszek: „Quality determining parameters of
pushed against the totally occluded vessel until the balloon angioplasty catheters", /. of Invasive Cardi-
maximum proximal force of 3.5 N was reached. The ology, vol. 8-4, pp. 144 - 152,1996
numerical results are given in figure 7.

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