throbber
Medical Engineering & Physics 37 (2015) 23–33
`
`Contents lists available at ScienceDirect
`
`Medical Engineering & Physics
`
`j o u r n a l h o m ep a g e : w w w . e l s e v i e r . c o m / l o c a t e / m e d e n g p h y
`
`Morphological and stent design risk factors to prevent migration
`phenomena for a thoracic aneurysm: A numerical analysis
`H.-E. Altnji ∗, B. Bou-Saïd 1, H. Walter-Le Berre 2
`
`Laboratoire de Mécanique des Contacts et des Structures, INSA de Lyon, 18-20 rue des Sciences, 69621 Villeurbanne, France
`
`a r t i c l e
`
`i n f o
`
`a b s t r a c t
`
`Article history:
`Received 20 September 2013
`Received in revised form 21 August 2014
`Accepted 30 September 2014
`
`Keywords:
`Aortic aneurysm
`Migration
`Type I endoleak
`Finite element
`Self-expanding stent
`
`The primary mechanically related problems of endovascular aneurysm repair are migration and type
`Ia endoleaks. They occur when there is no effective seal between the proximal end of the stent-graft
`and the vessel. In this work, we have developed several deployment simulations of parameter-
`ized stents using the finite element method (FEM) to investigate the contact stiffness of a nitinol
`stent in a realistic Thoracic Aortic Aneurysm (TAA). Therefore, we evaluated the following factors
`associated with these complications: (1) Proximal Attachment Site Length (PASL), (2) stent over-
`sizing value (O%), (3) different friction conditions of the stent/aorta contact, and (4) proximal neck
`angulation ˛.
`The simulation results show that PASL > 18 mm is a crucial factor to prevent migration at a neck angle
`of 60◦, and the smoothest contact condition with low friction coefficient ((cid:2) = 0.05). The increase in O%
`ranging from 10% to 20% improved the fixation strength. However, O% ≥ 25% at 60◦ caused eccentric
`deformation and stent collapse. Higher coefficient of friction (cid:2) > 0.01 considerably increased the migra-
`tion risk when PASL = 18 mm. No migration was found in an idealized aorta model with a neck angle of
`0◦, PASL = 18 mm and (cid:2) = 0.05. Our results suggest carefully considering the stent length and oversizing
`value in this neck morphology to strengthen the contact and prevent migration.
`© 2014 IPEM. Published by Elsevier Ltd. All rights reserved.
`
`1. Introduction
`
`Aortic aneurysm disease is characterized by a dilatation of the
`aorta as a result of weakness in the aorta wall. This leads to changes
`in wall tension with reduced tensile strength and finally rupture.
`Therefore, it is essential that aneurysms be repaired prior to fatal
`rupture. Two treatment strategies are possible: traditional surgery
`and endovascular aneurysm repair (EVAR) procedures. EVAR pro-
`poses a less invasive form of treatment and has undergone a
`dramatic technological evolution. An endovascular stent graft is a
`device used to seal off the aneurysm from inside the aorta pro-
`viding a new pathway for the blood flow through the region of an
`aneurysm.
`The main mid- and long-term mechanical related complications
`of EVAR are migration and type Ia endoleaks [1]. An endoleak is
`
`∗ Corresponding author. Tel.: +33 4 72 43 84 52; fax: +33 4 78 89 09 80.
`E-mail addresses: hussameddinaltnji86@gmail.com (H.-E. Altnji),
`benyebka.bou-said@insa-lyon.fr (B. Bou-Saïd), helene.walter-le-berre@insa-lyon.fr
`(H. Walter-Le Berre).
`1 Tel.: +33 4 72 43 84 47; fax: +33 4 78 89 09 80.
`2 Tel.: +33 4 72 43 71 88; fax: +33 4 72 43 89 13.
`
`http://dx.doi.org/10.1016/j.medengphy.2014.09.017
`1350-4533/© 2014 IPEM. Published by Elsevier Ltd. All rights reserved.
`
`defined as the presence of blood flow outside the lumen of the
`endoluminal graft, but within the aneurysm sac. Type Ia endoleak
`occurs when there is an ineffective seal of the aneurysm sac at
`the proximal attachment zone of the endograft device [2,3] which
`allows a direct blood flow into the aneurysm sac. The flow will exert
`a pressure force on the aorta wall which can lead to rupture. Migra-
`tion is defined as an endograft movement proximally greater than
`10 mm which leads to type Ia endoleak. These complications have
`undergone clinical investigation and can be related to one or all
`of these Deployment Failure Factors (DFF): endograft undersizing
`[4,5], high drag forces due to severe angulation [6,7], and insuffi-
`cient length of the proximal attachment site [8,9]. Most numerical
`research using Computational Solid Mechanics (CSM) has focused
`on coronary stent deployment mechanisms [10–13] or intracra-
`nial aneurysm [14]. Certain authors [15] have demonstrated the
`efficiency of CSM by experimental validation of the numerical
`results [16] of two commercial stent grafts subject to severe bend-
`ing tests. More recently, investigations [17] have been conducted
`using CSM examining the previous complications, however, this
`work focused mainly on idealized vessel geometry and an unreal-
`istic 3D geometric-connected stent behavior without investigating
`the mechanism of proximal stent migration. Moreover, stent col-
`lapse [18] or eccentric deformation in severe neck angulation has
`
`TMT 2122
`Medtronic v. TMT
`IPR2021-01532
`
`

`

`24
`
`H.-E. Altnji et al. / Medical Engineering & Physics 37 (2015) 23–33
`
`Fig. 1. (a) 3D reconstruction of aorta with centerline extraction. (b) Hexahedral mesh discretization. (c) The main definitions regarding the morphological criteria for (TAA).
`
`(cid:3)iso( ¯C) describe the so-called volumetric elas-
`(cid:3)vol(J) and
`where
`tic response, and the isochoric elastic response of the material,
`respectively [26]. The generalized Mooney–Rivlin hyperelastic
`constitutive model was used. The decoupled polynomial represen-
`tation of the strain energy function is given by,
`
`1D
`
`i
`
`N(cid:2)
`
`N(cid:2)
`
`=
`
`(cid:3)
`
`not yet been examined. In another study by Prasad et al. [19] aimed
`endoleak, stented endografts were
`at investigating the type
`subjected to displacement forces to investigate the contact stabil-
`ity at the intermodular junctions of a multi-component thoracic
`endograft in patient-specific TAA. However, the contact stability
`at proximal and distal attachment sites was not evaluated as the
`interaction of the aorta/stent graft at these sites was considered to
`be perfect.
`The present paper is a follow-up to our previous paper [20]
`which was the premise of this project. The main advantages of
`this work are to find, based on a 3D FEM platform, the mechan-
`ical, morphological, and stent design factors which lead to stent
`migration and can cause stent collapse or poor contact between the
`stent and the aorta at the attachment sites. This was accomplished
`by evaluating the contact stiffness in the stent/aorta interaction
`area after stent deployment using a Coulomb frictional model in
`a short-term stent fixation frame. Therefore, seven parameterized
`stent models were used to evaluate the following DFF in a patient-
`specific TAA: (1) the Proximal/Distal Attachment Site Length, (2)
`the stent Oversizing values (O%), (3) different stent/aorta contact
`friction conditions, and (4) the proximal neck angulation (˛).
`

`
`2. Materials and methods
`
`2.1. Patient specific TAA and stent models
`
`The FEM patient-specific TAA model was the same as for the
`previous work [20], starting from the planar slices obtained from
`the clinical CT scans in plane resolution. The reconstruction interval
`equals to the slice thickness of 0.73 mm. The pre-stenting vessel
`centerline was calculated to guide stent positioning. The meshing
`of the finite elements was developed using C3D8R element type as
`shown in Fig. 1.
`Although the anisotropy of the wall properties has been well
`recognized [21–23], the blood vessel in our case can be consid-
`ered as isotropic as the degree of anisotropy is small [24,25]. In the
`Abaqus/Explicit software package used, we must provide sufficient
`compressibility for the code to work. It was defined as K0/(cid:2)0 = 20
`(cid:2)0 the initial shear mod-
`where K0 is the initial bulk modulus and
`ulus. The material was considered as isotropic hyperplastic, and
`nearly incompressible. The decoupled representation of the strain-
`=
`(C) is given by the function,
`energy function
`
`(cid:3)
`
`(cid:3)
`
`(1)
`
`(cid:3)iso( ¯C),
`
`
`
`+
`
`(cid:3)vol(J)
`
`=
`
`(cid:3) (C)
`
`(2)
`
`1)2i,
`
`
`
`−
`
`(J
`
`
`
`i
`
`(¯I2 −
` 3)
`
`j +
`
`Cij(¯I1 −
` 3)
`i=1
`i+j=1
`where N, Cij and Di are temperature-dependent material parame-
`ters. The strain invariants are denoted ¯I1 and ¯I2. The symbol J is the
`volume ratio or the elastic volume strain, while Di describes the
`compressibility of the material. The hyperelastic constants were
`determined from the experimental tests [27]. Only radial displace-
`ments of the nodes located on the upper and bottom surfaces were
`allowed. We assumed no internal and external pressure on the
`aneurysm. The effects of residual stresses [1,23] were also neglected
`given the fact that blood vessels can be in a nearly stress-free state
`when they are free from external loads [24]. The nominal uniform
`thickness was considered to be 3 mm [28].
`The stent geometric models were generated by means of a spe-
`cially developed parameterization algorithm, using global variables
`(all in mm) STOD = 17, STH = 0.6, SL = 21, BW = 0.7, SVW = 0.8, G = 4.6,
`GSC = 23.5 mm illustrated in Fig. 2a. Other variables (Ystrut, SW, R1,
`R2, SLS) were linked to previous ones by the equations given in
`Fig. 2a, where R1 and R2 are the inner and outer radius of strut
`vertex, respectively. We denote Ystrut as a circumferential distance
`of a single strut at the given diameter, and Nstruts = 10 is the num-
`ber of struts around the circumference of the stent. The stent was
`modeled starting from the master sketch with six strut columns
`along the stent. The 3D parametric stent model was then created
`with suitable operations in the CATIA V5R20 software. All stent
`models were carefully discretized with the C3D8R element type
`using hourglass control [29]. In order to produce accurate represen-
`tation of the actual stent geometry, the CAD stent model was driven
`by a rigid cylindrical surface, accomplishing the needed oversiz-
`ing value relative to the outer diameter of the aorta, as shown in
`Fig. 2b. In the shape setting simulation, nitinol was considered to be
`an elastoplastic material [30]. Then, the expanded stent model was
`added back into the assembly model in a strain-free manner. After
`mesh convergence analysis (see Appendix), we applied three ele-
`ments through the thickness, and four elements across the width
`with a reasonably refined mesh of the strut (Fig. 2b).
`In the deployment procedure, superelastic behavior of the niti-
`nol was assigned to the stent. The numerical implementation of
`
`

`

`H.-E. Altnji et al. / Medical Engineering & Physics 37 (2015) 23–33
`
`25
`
`Fig. 2. (a) Parametric stent model using variables and equations. (b) Shape setting simulation and mesh refinement.
`
`friction model. The model assumes that no relative motion occurs
`
`(3)
`
`,
`
`(cid:7)
`
`(cid:6)
`
`<
`
`(cid:4)crit =
`
`
`
`(cid:2)p
`
`(cid:5)
`
`(cid:4)
`
`(cid:4)2
`2
`
`+
`
`(cid:4)2
`1
`
`(cid:4)eq =
`
`if,(cid:3)
`
`(cid:4)2 are the two
`(cid:4)1 and
`where ¯(cid:4)eq is the equivalent shear stress; and
`shear stress components that act in the slip directions of the contact
`(cid:4)crit represents the critical shear stress, while
`surfaces. The symbol
`is the friction coefficient, and P is the contact pressure. The slip
`between stent and aorta will not occur when,
`
`(cid:3)
`
`(cid:5)
`
`¯(cid:4)eq
`(cid:2)p <
` 1
`
`(cid:2)
`
`( ¯(cid:4)eq <
`
`
`
`(cid:2)p)
`
`(4)
`
`(5)
`
`(6)
`
`,
`
`⇔
`(cid:3)
`
`,
`
`(cid:5)
`
`but will occur when
`( ¯(cid:4)eq≥(cid:2)p)
`⇔
`
`¯(cid:4)eq
`(cid:2)p≥1
`
`≤ ¯Fcs ≤
` 1,
`
`
`
`The ratio,
`¯Fcs = ¯(cid:4)eq
`(cid:2)p
`
`,
`
`0
`
`this model was developed by writing a user-material subroutine
`following the model proposed by Auricchio et al. [31]. Nitinol
`material characterization was obtained from the literature [32].
`Mesh convergence analysis for both stent and aorta was per-
`formed, as shown in Appendix. The convergence criterion was
`based on the relative difference in von Mises stress and logarithmic
`strain.
`
`2.2. FEM stent deployment procedure
`
`The stent deployment was performed using a virtual deformable
`catheter surface meshed with a SFM3D4R element type, as shown
`in Ref. [20]. Starting from a straight configuration of the catheter,
`we calculated the needed displacements of the nodes comprising
`the aorta centerline (i.e., compression, displacement and bend-
`ing). The displacements were obtained in the insertion phase,
`and re-enlarging in the deployment phase (Fig. 3a). When the
`stent was deployed, the distance between two adjacent columns
`of struts Y was calculated along and around the circumference
`of the stent to evaluate the strut deformation, see Fig. 3 and
`Table 1.
`Concerning the high nonlinearity of the model, Abaqus/explicit
`6.11 was used as the finite element solver in a quasi-static analy-
`sis. We used a mass scaling technique [29,33,34] to decrease the
`time period without generating significant inertia forces (again,
`see Appendix). Since the solution converged with the applied
`mesh for contact and pressure forces, the results were con-
`sidered to be acceptable. The analysis was performed in the
`framework of classical continuum mechanics under large strain
`conditions.
`
`3. Stability of the stent/vessel contact
`
`Defines the friction contact stability ¯Fcs and stick/slip behav-
`ior between stent and aorta. High values of ¯Fcs mean high shear
`wall stress which can lead to an unstable contact until high slip
`is expected when ¯Fcs≥1. In this case, small values of the so called
`“pullout” or static downward forces needed to dislodge the stent
`from its attachment site may lead to significant migration. A total
`of eleven simulations were performed as illustrated in Table 2.
`
`4. Results
`
`4.1. Post processing
`
`Fig. 3a illustrates the reference deployment simulation process
`for stent 1 with PASL = 18 mm and O% = 15%. An idealized opposition
`⇔ ¯Fcs =
` 0, so that no slip is expected
`is assumed meaning
`once stent–aorta contact occurs. In the deployment phase, the stent
`expands with the superelastic effects until it contacted with the
`
`∞
`=
`(cid:2)
`
`The interaction between the contacting surfaces is controlled by
`two components, one being normal and the other tangential to the
`surfaces. The tangential behavior defines the relative motion (slid-
`ing) between the contacting surfaces. Hard contact model behavior
`[35] was used as the behavior in the normal direction. The tan-
`gential behavior was described by the classical isotropic Coulomb
`
`

`

`26
`
`H.-E. Altnji et al. / Medical Engineering & Physics 37 (2015) 23–33
`
`Fig. 3. Reference deployment simulation. (a) Deployment procedure. (b) Principal stresses distribution (MPa) in the aorta.
`
`Table 1
`Distance between two adjacent columns of struts.
`
`Group (G)
`
`Initial state (X = Y)
`G1SC = 23.549
`G2SC = 23.549
`G3SC = 23.549
`G4SC = 23.549
`G5SC = 23.549
`
`(G1) with bar
`
`Deployed state (Y)
`Y1 = 23.541
`Y2 = 23.544
`Y3 = 23.566
`Y4 = 23.559
`Y5 = 23.548
`
`(G2)
`
`Y1 = 22.5
`Y2 = 29.97
`Y3 = 30.22
`Y4 = 24.7
`Y5 = 23.8
`
`(G3)
`
`Y1 = 22.86
`Y2 = 24.74
`Y3 = 23.34
`Y4 = 23.28
`Y5 = 27.33
`
`(G4)
`
`Y1 = 23.93
`Y2 = 15.41
`Y3 = 14.75
`Y4 = 22.4
`Y5 = 34.33
`
`(G5)
`
`Y1 = 24.33
`Y2 = 18.15
`Y3 = 16.35
`Y4 = 23
`Y5 = 31
`
`aorta applying Radial Force RF. At the proximal and distal attach-
`ment sites, a radial decrease was observed in the deployed stent
`due to the Radial Compressive Forces (RCF) applied by the aorta.
`When the stent was fully deployed, RF and RCF forces were in equi-
`librium [36]. The previous history of deployment behavior can be
`described only when no migration or folding takes place. Fig. 3b
`shows the stress distribution in the aorta when the stent is fully
`deployed.
`The maximum values of the principal stresses were always
`observed near the proximal and distal attachment sites, where the
`cross-section of the vessel is undergoes large change.
`
`When deployed, some peaks of stent (group 2) move further
`apart and others move closer, see Fig. 3 and Table 1. The abso-
`lute distances between the peaks of struts in group 2 (Y2, Y3, and
`Y4) showed the longest deformation distance between the stent
`struts. These rings were slightly opened further during deployment
`(Fig. 3a).
`Based on the contact output variables, i.e., the normal, shear and
`pressure contact forces; we evaluated the ‘average contact stability’
`¯Fcs in both the proximal and distal landing zones from Eq. (6) for
`every deployment procedure, where only positive contact pressure
`stresses were generated.
`
`VI(Stent 2)
`
`D2P = 21
`D2D = 18
`15%
`= 0.05
`
`(cid:2)
`
`20%
`= 0.05
`
`(cid:2)
`
`V(
`
`Stent 1)
`
`D1P = 18
`D1D = 15
`15%
`∞
`=
`(cid:2) = 0.05
`(cid:2) = 0.1
`(cid:2) = 0.5
`
`(cid:2)
`
`Table 2
`Parameterized-deployment simulations to evaluate the impact of several factors on migration.
`
`IV
`(Stent 3)
`
`D3P = 23
`D3D = 23
`25%
`= 0.05
`
`(cid:2)
`
`III
`(Stent 3)
`
`D3P = 23
`D3D = 23
`20%
`= 0.05
`
`(cid:2)
`
`II
`(Stent 3)
`
`D3P = 23
`D3D = 23
`15%
`= 0.05
`
`(cid:2)
`
`I(
`
`Stent 3)
`
`D3P = 23
`D3D = 23
`10%
`= 0.05
`
`(cid:2)
`
`Deployment simulation (Angulated proximal neck)
`
`Proximal attachment site (mm) (PASL)
`Distal attachment site length (mm) (DASL)
`Oversizing value (O%)
`Tangential contact behavior (coefficient of friction)
`
`(non-Angulated proximal neck)
`
`Proximal attachment site length (mm)
`Distal attachment site length (mm)
`Oversizing value (O%)
`Tangential contact behavior (coefficient of friction)
`
`(Stent 1)
`
`D1P = 18
`D1D = 15
`15%
`
`((cid:2) = 0.05)
`
`

`

`H.-E. Altnji et al. / Medical Engineering & Physics 37 (2015) 23–33
`
`27
`
`Fig. 4. Proximal and distal attachment site lengths (D) (mm) just after the first interaction moment (stent–aorta), (O%) = 15%. We consider (D = P/DASL); D represent the
`complete contact distance (stent–aorta).
`
`were proximally controlled by accurate positioning at the insertion
`phase.
`In simulation V15% (Fig. 5), stent 1 was deployed with
`is
`longer than the critical clinic safety
`PASL = 18 mm, which
`distance of 15 mm [1,2,37]. However, in the critical contact con-
`
` = 60◦) with
`dition ((cid:2) = 0.05) and high proximal neck angulation (˛
`O% = 15%, stent 1 migrated at the proximal site by more than 15 mm,
`resulting in a higher stress concentration against the aorta [20] with
`a highly instable contact ( ¯Fcs = 1) proximally, and ( ¯Fcs = 0.99) dis-
`
`
`tally, as shown in Fig. 10a. No significant migration was observed at
`the distal attachment site. On the other hand, stent 2 and stent 3 in
`
`4.2. The effect of proximal-distal attachment site length
`(PASL-DASL)
`
`Three simulations of deployments have been performed (V15%,
`џ). The stent sizes are as follows: stent 1 = 144 mm, stent
`VI, and
`2 = 160 mm, and stent 3 = 185 mm, respectively; with the attach-
`ment zone lengths indicated in Table 2 and an oversizing value
`of O% = 15%. The smoothest contact condition between stent and
`aorta was considered to be
`= 0.05. Fig. 4 shows the length of the
`attachment sites when the stent-aorta interaction starts and the
`total superelastic recovery has not yet taken place. These lengths
`
`(cid:2)
`
`Fig. 5. Impact of proximal-distal attachment site length on migration and stability of deployment, (O%) = 15%.
`
`

`

`28
`
`H.-E. Altnji et al. / Medical Engineering & Physics 37 (2015) 23–33
`
`Additionally, the 20% oversized stent 3 showed more connected
`strut points with the vessel in the attachment sites, see Fig. 6b.
`However, oversizing the stent 3 by 25% in the tortuous geome-
`try produced a considerable amount of eccentric stent deformation
`[18] during the insertion phase. As a result, the eccentric stent
`expanded with unequal radial forces which caused the struts to be
`oriented away from the aorta when the stent was fully deployed.
`This produced inconstant frictional forces, and consequently a very
`poor interaction with the aortic wall (Fig. 6c).
`
`4.4. The effect of tangential contact behavior
`
`(cid:2)
`
`≤
`(cid:2)
`≤
`
`(cid:2)
`
`(cid:2)
`
`(cid:2)
`
`(cid:2)
`
`(cid:2)
`
`for vessel/stent contact is
`The value of friction coefficient
`ranged between 0.05
`0.5 [41]. The pathological state of the
`aorta (atherosclerotic plaques, calcifications, etc.) can significantly
`change the
`value. Thus, it seems necessary to investigate the
`effect of
`on the contact stability for the migrated stent 1 only.
`Three extracted experimental friction coefficients [41] were used
`= 0.05, 0.1, and 0.5.
`for the simulation V15%, namely,
`As seen previously, stent 1 migrated under the smoother con-
`= 0.05. On the other hand, when
`= 0.1, the
`tact condition
`results showed that stent 1 has also slipped, but by a negli-
`gible proximal migration distance. The distance involved was
`MIG = 3.5 mm < 10 mm, i.e., no migration failure, see Fig. 7. More-
`over, no distal migration was reported.
`Additionally, when
`= 0.5, the stent was deployed with almost
`no slip or migration. A higher friction coefficient
`= 0.5 proximally
`improved the contact stability by an average 17.5% decrease, rel-
`ative to the moderate contact condition at
`= 0.1, (0.80 vs. 0.97);
`and a 20% decrease from the smoothest contact condition
`= 0.05
`(0.80 vs. 1). It also improved the distal contact stiffness, see Fig. 10c.
`Fig. 7b also displays the stress distribution of stent 1 for three dif-
`ferent coefficients of friction.
`The average contact pressure history introduced in the ves-
`sel during deployment was almost constant for every element
`in the proximal and distal sites when
`= 0.1 and
`= 0.5. Dur-
`ing stent deployment, the contact pressure stresses decreased
`slightly because of radial compressive stresses applied by the aorta
`until equilibrium was reached, see Curves 1, 2 and 3 in Fig. 8.
`
`(cid:2)
`
`(cid:2)
`
`(cid:2)
`
`(cid:2)
`
`(cid:2)
`
`(cid:2)
`

`
`were deployed without any migration failure
`simulations VI and
`(Fig. 5). Stent 2 and stent 3 resulted in a better contact stability,
`with 10% improvement in the proximal zone compared to stent 1
`(0.90 vs. 1). Only stent 3 improved the contact stability at the distal
`site, see Fig. 10a. These results are in good agreement with clinical
`findings that associate short PASL with unstable deployment and
`migration [2,8,9,37,38]. However, PASL is not the only component
`that leads to migration, as clinical results show [2,4].
`
`4.3. The effect of the oversizing value O%
`
`Stent oversizing is defined as,
`
`Oversizing (%)
`
`= Dstent
`Daorta
`
`,
`
`where Dstent is the outer diameter of stent and Daorta is the outer
`џ,
`diameter of aorta. Five simulations were performed (V20%, I,
`Ш, and IV). Initially, the migrated stent 1 was oversized by 20%
`and deployed with
`= 0.05. The result showed that stent 1 with
`O% = 20% has also undergone migration failure with high insta-
`ble contact ¯Fcs = 1 proximally, and ¯Fcs = 0.99 distally, see Fig. 10b.
`
`
`However, the proximal slip distance was MIG = 13.5 mm > 10 mm
`(Fig. 6a). The migration distance was not particularly important
`compared to the 15% oversized stent 1 MIG = 18 mm
`10 mm, i.e.,
`25% improvement of migration behavior. These results agree with
`experimental findings [4] which associate the insignificant impact
`of oversizing with the contact strength at high neck angulation
`[9,39].
`Moreover, four simulations of stent 3 were performed with
`10–25% oversizing values to investigate the risk of neck enlarge-
`ment [40] or stent collapse [18]. The results showed that oversizing
`stent 3 from 10% to 20% resulted in an almost constant normal and
`frictional force distribution, without aortic neck enlargement [40]
`or migration failure. For larger oversizing value, the radial forces
`were larger. Therefore, the 20% oversized stent 3 resulted in a more
`stable contact with ¯Fcs = 0.6 proximally, i.e., a 24.4% improvement
`
`compared with the 15% oversized stent 3 (0.68 vs. 0.9). A 28.6%
`improvement was found in the distal site (0.60 vs. 0.84), see Fig. 10b.
`
`(cid:8)
`
`(cid:2)
`
`Fig. 6. (a) Impact of 20% oversizing value on stent 1 migration. (b) Contact pressure stresses (MPa) in the aorta for different values of oversizing. (c) Stent 3 collapse when
`excessive oversizing.
`
`

`

`H.-E. Altnji et al. / Medical Engineering & Physics 37 (2015) 23–33
`
`29
`
`Fig. 7. (a), (c) Stent 1 migration risk and principal stresses (MPa) contour with respect to different tangential behaviors, simulation (V). (b) Vector plot of the dominant shear
`forces (N) in the migrated stent.
`
`results showed that stent 1 did not migrate in the straight proxi-
`
`mal neck even for the smoothest contact condition ((cid:2) = 0.05), see
`Fig. 9b.
`The average contact stability decreased significantly with 20%
`of contact improvement in the proximal site (0.80 vs. 1), and 23% of
`contact improvement in the distal site (0.99 vs. 0.76), see Fig. 10d.
`= 0◦, more stent/aorta surface interaction was reported, and
`When
`higher contact pressure was obtained.
`

`
`5. Discussion
`
`We found that proximal length was a crucial factor in contact
`strength to prevent migration in the smoothest contact condi-
`tion with severe angulation. In such conditions, the length of the
`safety-clinical proximal landing zone (15 mm) was not sufficient
`
`However, this behavior was different for many aorta elements
`that lost contact with stent 1 when
`= 0.05 after migration failure
`(Curve 4).
`
`(cid:2)
`
`4.5. Effect of proximal neck angulation
`
`The previous patient-specific morphology shows high proximal
`= 60◦, see Fig. 1. According to Sternbergh [43],
`angulation with
`neck angulation severity can be classified into the cases of mild
`(<40◦), moderate (40–60◦), or severe (>60◦).
`investigate the effect of challenging neck anatomy on
`To
`the incidence of migration, we used an idealized aneurysmal
`
`aorta model with zero proximal angulation (˛ = 0◦) assuming the
`
`smoothest contact behavior ((cid:2) = 0.05) and oversizing O% = 15% for
`= 60◦, the
`stent 1 (Fig. 9a). Contrary to the migrated stent 1 when
`

`

`
`Fig. 8. The maximal contact pressure stresses (p) contour (MPa) induced in the aorta for three different ((cid:2)) values after stent 1 deployment. Curves 1, 2, and 3 represent
`the average (p) evolution with time simulation in both proximal and distal attachment sites. Curve 4 shows the behavior of one vessel element that lost the contact after
`migration failure.
`
`

`

`30
`
`H.-E. Altnji et al. / Medical Engineering & Physics 37 (2015) 23–33
`
`to prevent migration failure. One important issue is that ¯Fcs was
`calculated just after the first instant of interaction for the stents
`undergoing migration (>10 mm), and when full stent deployment
`was reached for non-migrated stents (<10 mm).
`= 60◦, with O% = 15% and 20%, (Simulation
`When
`= 0.05 and
`V), stent 1 began to interact with the vessel, and the radial contact
`forces at the proximal site began to increase. Subsequently, when
`superelastic recovery took place, the shear forces which dislodge
`the stent increased due to the angulation that decreased the surface
`of interaction. These forces became higher than the radial stiffness
`strength of stent 1, while the normal contact forces decreased sig-
`nificantly and migration failure took place. Fig. 7b shows a metric,
`namely, a vector plot of the dominant shear force direction, just
`before the instant of stent 1 migration.
`These results are in good agreement with the clinical findings
`that associate short PASL with unstable deployment and migration
`[2,8,9,37,38]. However, it is clear that PAS is not the only component
`that leads to migration as clinical results show [2,4].
`showed that the length of stent 3 (185 mm)
`The simulations VI,
`was more than enough to avoid migration. Moreover, oversizing
`stent 1 by 20% was beneficial, but insufficient, to avoid migration
`failure. This is particularly true when the proximal attachment zone
`is critical, as in stent 1. The distal attachment length does not seem
`to have a significant effect on the risk of rupture, as notable migra-
`tion was not in evidence. This result agrees with the clinical finding
`

`
`(cid:2)
`

`
`Fig. 9. (a) Idealized aneurysmal aorta. (b) Principal stress contour (MPa) induced
`when stent 1 deployment without migration.
`
`Fig. 10. Contact stability vs. factors affecting stent 1 migration. (a) Proximal stent length. (b) Oversizing value. (c) Coefficient of friction. (d) Proximal neck angulation.
`
`

`

`H.-E. Altnji et al. / Medical Engineering & Physics 37 (2015) 23–33
`
`31
`
`Fig. 11. ALLKE/ALLIE ratio for stent 1 and aorta during insertion and deployment procedures in the reference model simulation.
`
`that suggests giving more control for precise proximal placement,
`with minimal control over the distal attachment site [1,2]. The 20%
`oversized stent 3 resulted in the best contact stiffness outcomes
`compared to 10% and 15% oversized stent 3. The 10% and 15% over-
`sized conditions of stent 3 did not show considerable differences
`in their respective results. More importantly, despite the fact that
`many devices have been deployed in angulated necks (>60◦) with-
`out stent enfolding, stent collapse becomes more critical when both
`oversizing and neck angulation increase; particularly, when the
`stent is placed higher in both the proximal and distal attachment
`sites, i.e., stent 3. This placement can lead to single-side progressive
`strut dilation and subsequent rupture.
`These results are consistent with the medical findings which
`associate eccentric stent deformation with migration and type
`Ia endoleaks [18,38,43]; and excessive oversizing (>25%) with an
`increased potential of stent enfolding [4,42,44,45], and neck dilata-
`tion with subsequent migration [6]. Therefore, a suitable level of
`oversizing should be chosen for a specific level of neck angulation
`and the stent should be placed higher only in the proximal case
`(stent 2) as supported by clinical studies [1].
`The results also show the importance of the pathological state
`of the aorta represented by different coefficients of friction. The
`roughest contact condition produced the best contact stiffness
`and high normal contact forces compared with tangential contact
`forces. These results can explain the different clinical deployment
`results for different pathological aorta states [46].
`Finally, severe proximal neck angulation was the most impor-
`tant cause of poor deployment where
`the fixation
`length,
`interaction surface quality, and stent opposition are reduced, and
`the struts are not circumferentially uniform. In the non-angulated
`aorta, stent 1 applied a higher radial force distribution on the larger
`surface of the vessel. Thus, the contact normal forces increased and
`became higher than the shear forces. Therefore, a good opposi-
`tion was obtained. This finding is consistent with reported clinical
`results [1,2,6–8,44,47]. Although severe angulation has been identi-
`fied as potential risk factor associated with migration failure, other
`factors, such as the short proximal landing zone and smooth contact
`condition, should be considered; they may also increase the shear
`downward forces. High angulation can be a major factor in stent
`folding and poor deployment, increasing the risks of migration and
`type Ia endoleaks.
`
`Moreover, our results show that in our real morphology, not
`every point on the strut surface is in contact with the aortic wall
`when it exhibits irregular contour at the attachment sites. This
`fact becomes more apparent in cases of high angulation and blood
`vessel pathology.
`
`6. Limitations
`
`The present study considers that deployment success is deter-
`mined only by the mechanical fixation applied by the stent [48].
`Similar to previous research [19], we did not investigate the influ-
`ence of the graft on the results. Other authors [19] assumed that
`the graft has little contribution to the proximal radial stiffness com-
`pared to the nitinol stent when final device deployment is achieved.
`The study in Ref. [49] states that the graft material can contribute
`to different mechanical behavior as the rings can be constrained by
`the graft material exerting upward component forces. Our study
`focused only on short-term stent fixation. In this case, we suspect
`that the wall shear stresses induced by the blood flow are negligi-
`ble compared to normal forces applied by the spring action when
`the stent had just been deployed. Future work will include the graft
`and the residual stresses [23,50] to evaluate long-term fixation of
`the stent graft under hemodynamic factors [51,52] throughout the
`cardiac cycle.
`Moreover, the lumen of the vessel was reconstructed in the
`model regardless of the calcifications and the varied thickness [53].
`We believe that this approximation will not significantly affect the
`contact behavior at attachment sites. Finally, for the objectives of
`our study, we believe the isotropic hyperelastic model of the aorta
`is appropriate. However, many other models [21,22,54] can be used
`to describe an anisotropic mechanical response of thoracic aorta.
`
`7. Conclusion
`
`In this work, we evaluated the contact s

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket