Jtam-A4.dvi JOURNAL OF THEORETICAL AND APPLIED MECHANICS 54, 2, pp. 411-421, Warsaw 2016 DOI: 10.15632/jtam-pl.54.2.411 A PRELIMINARY STUDY ON THE OPTIMAL CHOICE OF AN IMPLANT AND ITS ORIENTATION IN VENTRAL HERNIA REPAIR Izabela Lubowiecka, Katarzyna Szepietowska Gdansk University of Technology, Faculty of Civil and Environmental Engineering, Gdańsk, Poland e-mail: lubow@pg.gda.pl; katszepi@pg.gda.pl Czesław Szymczak Gdansk University of Technology, Faculty of Ocean Engineering and Ship Technology, Gdańsk, Poland e-mail: szymcze@pg.dga.pl Agnieszka Tomaszewska Gdansk University of Technology, Faculty of Civil and Environmental Engineering, Gdańsk, Poland e-mail: atomas@pg.gda.pl This paper addresses the problem of ventral hernia repair. The main goals are to find an optimal surgical mesh for hernia repair and to define its optimal orientation in the abdomi- nalwall tominimise themaximum force at the tissue-implant juncture. The optimalmesh is chosen from a set of orthotropicmeshes with different stiffness ratios for typical hernia pla- cement in the abdominal area.The implant is subjected to an anisotropicdisplacement field, different for the selected hernia placements. The assumed displacement fields correspond to regularhumanactivity.Proper implantationof themeshmaydetermine the success of hernia repair and/or the postoperative comfort of patients.The proposed solution is based onFEM simulations of different surgicalmeshes behaviour. In typical hernia placements, the optimal orientation of the stiffer direction of the implant is perpendicular to the spine. However, the presented results show some cases that an oblique directionmay be the optimum one. Keywords: biomechanics, surgical mesh, finite element modelling, optimisation 1. Introduction Ventral hernia is a common medical problem researched by surgeons and engineers for many years, but question about themain factors influencing hernia repair efficiency still remains open (Muysoms et al., 2013). This problem refers to primary hernias as well as to incisional ones. It is estimated that there is a 12% chance of incisional ventral hernia occurrence after abdominal surgery and a 3.2% chance after laparoscopic operation (Bensley et al., 2013). Laparoscopic ventral hernia repair is believed to be superior to an open operation (Qadri et al., 2010), however the best treating scheme is not specified for the time being, and such problems as recurrences or chronic pain happen (Sommer and Friis-Andersen, 2013). It is believed that the success of ventral hernia repair depends mainly on selection of an appropriate implant and its fixation (Muysoms et al., 2013). In the authors’ opinion, mathematical modelling and simulations can provide information about the best course of the treatment, and then, a combination ofmedical andmechanical knowledge may lead to an increase in hernia treatment efficiency. This paper refers to laparoscopic repairs.Theprinciple that the properties of surgicalmeshes shouldmatch the properties of the abdominal wall and that implants should be oriented in the human body in accordance with the mechanics of the abdominal wall has been reported in the literature since 2001 (Junge et al., 2001). This issue was discussed e.g., byKirilova et al. (2012), Hernández-Gascón et al. (2013), Anurov et al. (2012). All these studies are limited to just one 412 I. Lubowiecka et al. position of hernia orifice and two perpendicular orientations of implants. As the abdominal wall is subjected to various strains during human activity, both in magnitudes and in orientations in different locations (Szymczak et al., 2012), it is reasonable to find the best orientation of the implant for different hernia locations in the abdominalwall. This problemwas already addressed in (Lubowiecka et al., 2014). The main goal of this study is to investigate the influence of implants orientation on forces in fasteners. The value of this force determines the success of hernia repair since its increase can lead to the junction failure which is a common cause of the illness recurrence.The maximum force on a fastener affixing an implant should be smaller than the allowable tearing force for a selected tack (Tomaszewska et al., 2013). The proposed solutions are derived from structural mechanics and optimisation methodology. In order to analyse the behaviour of the surgical mesh, amathematical model of the tissue-implant system, which is created during laparoscopic hernia operation, is applied. The modelling of implant-tissue systems began with the cable model (Szymczak et al., 2010). Next, two-dimensional finite element (FE) membrane models with various boundary conditions were defined (Lubowiecka et al., 2010; Lubowiecka, 2015; Tomaszewska et al., 2013). An FE model of the implant-hernia system was also proposed by Guérin and Turquier (2013) and Hernández-Gascón et al. (2013). Some mechanical properties of surgical meshes were recognized for their application in different material models including an orthotropic linear or bilinear elastic material model (Lubowiecka et al., 2014) or a dense net material model (Lubowiecka, 2015), a hyperelastic constitutive model (Hernández-Gascón et al., 2013) and a beammodel reflecting the implant material structure (Hernández-Gascón et al., 2012). The novel approach presented in this paper is formulating and solving the optimisation problem,which results in the selection of theoptimal orthotropic implant and its best orientation in the anisotropic abdominal wall. We consider five possible hernia placements, where implants are imposed to different fields of displacements caused by deformation of abdominal wall during daily activities. The optimisation criterion is minimising the maximum forces on tissue-implant junctures resulting from the patient’s bodymovements. 2. Materials and methods 2.1. Formulation of the optimisation problem The force acting on a single fastener of a given type ofmesh implant depends on the implant mechanical properties, its orientation relative to the direction of the spine, and the layout of the fasteners. In this model, a circular layout of point fasteners is assumed. To find the optimal orientation for an implant, the minimisation of the force F(i,α,s) is defined as an objective function min i∈I, 0¬α¬2π, s⊂S max F(i,α,s) (2.1) where i denotes the number of fasteners indicating their position, I stands for the fastener set, α is the angle between the implant primary axis and the spine, and s indicates the implant number from the set of implants S considered. A three-stage process of minimising objective function (2.1) is proposed herein. During the first stage, themaximum forceFmax(i,α,s) in the fastener is sought for a chosen implant s and the implant angle of orientation as a solution of the sub-problem (according to Eq. (2.2). The outcome of this step is the number i0 that indicates the fastener at which Fmax occurs max i∈I F(i,α,s) (2.2) A preliminary study on the optimal choice of an implant... 413 In the second stage, the angle specifying the implant orientation in relation to the spine is sought. The problem is formulated as aminimisation of themaximum force obtained in the first stage with respect to the angle α min 0¬α¬2π Fmax(i0,α,s) (2.3) Theminimisation procedure is conducted in a discretemanner; the implant orientation angle α changes by the assumed increment∆α. Thus the orientation angle of the implant α0 for which the minimal force in tack i0 (selected in the first step), is identified. In the last stage, steps one and two are repeated for each implant s from the considered set of implants S min s⊂S Fmax(i0,α0,s) (2.4) Finally, the implant s0, its orientation α0 and the corresponding fastener number i0 are deter- mined to solve the objective function. This finalises the optimisation procedure. 2.2. Modelling and simulation of the implanted surogical mesh Four popular synthetic implants used in ventral hernia repair are considered in this study, ProceedTM Surgical Mesh (Ethicon Endo-Surgery, Inc., USA), ParietexTM Composite (Covi- dien, USA), DynaMesh R O -IPOM (FEG Textiltechnik mbH, Germany) and Gore R O Dualmesh R O Biomaterial (W.L.Gore&Associates, Inc., USA). They are knitted structuresmade of polypro- pylene and cellulose, polyester, polypropylene and polyvinylidene fluoride treads, respectively. The lattermaterial is in formof a smoothmembranemade of expandedpolytetrafluoroethylene. A suggestion concerning proper orientation of the implant in the abdominal wall can be found only in specification of DynaMesh R O . Themanufacturer recommends a craniocaudal orientation of the mesh, but does not distinguish different hernia locations. The analysis refers to practi- cal cases concerning the first few weeks following the operation, when the implant is not yet encapsulated by a fibrous capsule and when most hernia recurrences occur. The correct mesh orientation decreases the risk of possible postoperative fixation failure evenwhen themechanical properties of the implant are changed due to tissue overgrowth (Oettinger et al., 2013). Herniawith an orifice diameter of 5cm is considered in this study.A standard clinical case is taken into account, in which the implant is affixed to the tissuewith point fasteners in a circular order. The least favourable situation is applied with 4cm spacing between fasteners. The circle of joints has a diameter of 13cm, and then a radial distance of 4cm between the hernia orifice edge and joints is preserved according to medical standards. There are 10 fasteners in such a layout. Themesh ismodelledwith apolygonalmembrane structure (Fig. 1a), supported in 10points. The numerical model of the implant is defined within the Finite Element Method using the MSC.Marc R O commercial system.Eight-nodemembrane elementsQUAD(8)with 3 translational degrees of freedom at each node are used. The model is discretised by 960 finite elements with mesh refinement around the tissue-implant joints (Fig. 1b). The model is subjected to kinematic extortions related to displacements of the abdominal wall when the patient moves. The range of extortions can be derived from a map of possible strains of the external layer of the abdominal wall, which was discussed by Szymczak et al. (2012). A summary of those results is presented in Fig. 2a. However, the strains on the internal surface of the abdominal wall are 2.6-fold smaller than on the external surface (Podwojewski et al., 2013). Thus the reduction factor of 2.6 is applied to the results described by Szymczak et al. (2012). The values and directions of maximal strains of the abdominal wall are different in its various regions, so the implant is subjected to various extortions when placed in different parts 414 I. Lubowiecka et al. Fig. 1. (a) Schememodel of the implanted surgical mesh; b) Finite Elementmesh Fig. 2. (a) Directions and values (in %) of strains on the external abdominal surface in different sections, according to Szymczak et al. (2012); (b) considered hernia cases Table 1.Reduced abdominal strains in the radial direction at the fastener imposed in themodel supports [%] [%] p1 p2 p3 p4 p5 p6 p7 p8 p9 p10 Case 1 9 3 3 6 7 7 6 3 3 9 Case 2 9 3 2 6 7 7 6 2 3 9 Case 3 12 4 3 7 9 9 7 3 4 12 Case 4 9 6 3 5 13 13 5 3 0 0 Case 5 9 5 3 7 13 13 7 3 5 9 of the abdomen. Thus, five hernia locations are considered as marked in Fig. 2b. For each case, the extortions are estimated basing on the abdominal strains presented in Fig. 2a, scaled by a factor of 2.6 and they are applied to the supporting points of themodel (p1 to p10, see Fig. 1a). The final values of the extortions applied to each supporting point are included in Table 1. Mechanical properties of themeshes selected for the analysis differ significantly. Orthotropic or isotropic, linear or bilinear elastic constitutive models have been identified for them, basing on Biot stress and Biot strain experimentally measured in one-dimensional tensile tests. The experiments are presented in (Tomaszewska et al., 2013). As one can notice, basing on the data summarised in Table 1, in each hernia case the meshes are subjected to strains smaller than 0.3. Thus, constitutive models of themeshes have been specified for the strain range 0-0.3. The least squaresmethod applied in theMarquardt-Levenberg algorithm is used for parameters A preliminary study on the optimal choice of an implant... 415 identification.Finally, theobtainedparameters of the constitutivemodels applied for eachkindof the implant are presented inTable 2. It has been observed thatDualmesh R O is a nearly isotropic material. The rest of the meshes considered here is distinctly orthotropic, but with different orthotropy ratios calculated asE1/E2.E1 andE2 are the elastic moduli of the implants derived for two perpendicular directions wherein E1 > E2. The directions of orthotropy, indicated by E1 andE2, for the considered meshes are marked in Fig. 3. Table 2.Parameters of linear or bilinear elastic orthotropicmaterial models of the implants for the strain range 0-0.3 Limit E [N/mm] E1/E2 Poisson’s Mesh A stress for for for for εl [–] ratio [N/mm] ε< εl ε> εl ε<εl ε> εl ν21 [–] Dualmesh (2.1) 8.4 28 1.1 N/A 0.3 (2.2) 6.1 26 DynaMesh (2.1) 4.5 6.4 14 18 39 0.15 0.3 (2.2) 1.7 0.36 N/A Parietex (2.1) 3.7 1.6 21 1.8 10 0.15 0.3 (2.2) 2.0 0.87 2.1 Proceed (2.1) 4.2 40 5.3 N/A 0.3 (2.2) 4.1 7.6 A – Direction of bigger (2.1) or smaller (2.2) stiffness of the mesh Fig. 3. Directions of the higher and lower stiffness of the consideredmeshes The accuracy of the implant model with a proposed polygonal shape has been successful- ly verified against experiments on a physical model of the system subjected to impact loads resulting from postoperative cough (Lubowiecka, 2015). The h-convergence analysis has been performed within simulations. According to the optimisation procedure described in Section 2.1, for each implant placed in each hernia case, the reaction forces in the supporting points are calculated (stage 1). Nonlinear static analysis in the range of large strains is performed. Twelve orientations of each implant in each simulated hernia location are considered (α=0-180 degrees with 15 degree intervals). The angleα=0 stands for the craniocaudal orientation ofE1 direction of the considered implant as marked in Fig. 1a. The influence of the implant orientation on reaction forces is expressed by the value of the coefficient D = (Fmax −Fmin)/Fm · 100%, where Fmax is the maximum reaction obtained for the orientation αmax,Fmin is the maximum reaction obtained for the orientation α0 (stage 2 of the optimisation). The smallest maximum reaction occurs for the optimal orientation α0 of the 416 I. Lubowiecka et al. implant andαmax is the orientation corresponding to the largest maximum reaction that occurs in the supporting points of the mesh. αmax is the least appropriate orientation. The larger the value of theD coefficient, the greater is the effect of the implant orientation on the reaction force. In the final step of the optimisation problem, the optimal solution described by the implant type along with its optimal orientation is found (implant type along with its optimal orientation). 3. Results The calculated values of the angles α0 and αmax along with D coefficients are presented in Table 3. For almost isotropic Dualmesh R O , D value does not exceed 5% in any area, but for other meshes it is visibly higher. The largest values of D are obtained for DynaMesh R O (36%-55%) and for ProceedTM (35%-53%). D value of ParietexTM is in the range of 26%-34%. Table 3.The best and the worst orientations of implants DynaMesh Parietex Proceed Dualmesh Case αmax α0 D αmax α0 D αmax α0 D αmax α0 D [deg] [deg] [%] [deg] [deg] [%] [deg] [deg] [%] [deg] [deg] [%] 1 15 75 36 15 90 28 30 90 36 15 75 4 2 15 75 42 15 90 26 30 90 35 15 75 5 3 15 75 47 30 90 29 15 90 47 15 90 4 4 165 75 55 90 60 34 0 75 53 165 75 3 5 15 90 48 15 90 33 15 90 50 15 90 4 Fig. 4. Maximum reactionsF max in meshes depending on the orientation angle α for the following implants: DynaMesh (DM), Parietex (Px), Proceed (P) and Dualmesh (DMG) Thevalues of allmaximumreaction forces obtained in this studyare presented inFig. 4. The distribution of all reactions in theworst and best orientation case is shown inFig. 5. Finally, the identified optimal orientations of three considered anisotropic implants for each hernia location considered here are shown inFig. 6. Dualmesh R O is the onlymesh investigated in this study that A preliminary study on the optimal choice of an implant... 417 Fig. 5. Reactions F obtained in each support for all investigated orientations of the implant, the solid line is for the best orientation, the dashed line is for the worst orientation of the mesh 418 I. Lubowiecka et al. Fig. 6. Optimal orientation anglesα0 (orientation of the direction ofE1) does not have distinct anisotropic properties. A single optimal orientation does not exist in such a case, any orientation is acceptable. 4. Discussion Figures 4-6 describe the effects of the implant material orientation on the reaction forces that occur at the supporting points in the tissue-implant interface. These forces cannot exceed the capacity of the tissue-implant juncture, otherwise the junction damage and recurrence of the sickness occurs. The larger the range of junction forces between themost and least appropriate orientations of the implant, the greater is the influence of the implant orientation on the forces in the supporting tacks. This range is measured byD coefficient presented in Table 3.D values of Dualmesh R O are relatively small (3%-5%), so any orientation of this mesh can be applied in practice. The largest D values are obtained for DynaMesh R O (33%-55%) and for ProceedTM (36%-53%), which means that surgeons should pay special attention to the proper orientations of those implants. Values ofD for ParietexTM are in the range of 28%-34%. Those results relate to the orthotropy ratio of eachmesh (Table 2). The largest forces for each implant can be found in zone 4 (see Fig. 4). Also the influence of orientation (represented byD value) is the highest in that zone. The results presented in Fig. 4 prove that the lowest maximal reactions are observed for ParietexTM in each hernia case. Variability of reaction forces in all fixation points for certain mesh orientations is shown in Fig. 5. These results prove that in the optimal orientation, the reactions are relatively low and they are the most evenly distributed on the supporting points comparing to other orientations. It is visible that in the case of Parietex, which initially has a small orthotropy ratio, the change of orientation from the worst to the optimal one causes reduction of the reaction forces but does not change significantly the shape of the reaction distribution graph.Whereas for strongly orthotropic meshes, like DynaMesh R O and ProceedTM in their optimal orientations, the distri- bution of forces ismore even. Such even force distribution justifies regularly spaced fixing joints. For an orientation different than the optimal, more joints (or stronger ones) should be used in places where larger reaction forces occur than in places with smaller reaction forces. In themajorityof cases considered in this study, theoptimalorientation of the stifferdirection of an implant is the transverse direction (90deg) of the abdominal wall (Table 3 and Fig. 6). This observation corresponds to the results obtained experimentally by Anurov et al. (2012) and numerically byHernández-Gascón et al. (2013), who investigated only two orientations of a surgical mesh in the central area of the abdominal wall. However, also a frequent solution of our optimisation scheme is 75deg especially for hernia located in zone 4. In this case when operating with ParietexTM, the optimal orientation of its stiffer direction is 60deg. The study emphasises the importance of the proper orientation of surgical mesh when im- posed to kinematic extortions related to abdominal wall movements. Thus we do not include constrains on the implant deflection related to bulging in the optimisation procedure. Bulging A preliminary study on the optimal choice of an implant... 419 is related to intraabdominal pressure load and does not take place when the implant undergoes only kinematic extortions. However, in amore general procedure of finding an optimal implant, additional constraints upon the maximum displacements could be included to avoid excessive bulging of the implant. 5. Conclusions This paper presents an investigation on the influence of orthotropic implant orientation on forces on tissue-implant junctures caused by deformation of the anisotropic abdominal wall.Moreover, it gives a study on the optimal choice of surgical orthotropic meshes and their orientation in ventral hernia repair. Surgeons may consider these results when choosing an implant and when determining its position in different areas of the abdominal wall, particularly when no manufacturer’s recommendation exists. Themost important findings are presented below. • The implant ParietexTM bestminimises reaction forces. Hence, according to our optimisa- tion procedure, application of this mesh gives the optimal solution. However DynaMesh R O has a better orthotropy ratio giving more even distribution of forces on all supporting points. • For optimal orientations of implants in the abdominal wall, forces acting on different supporting points have themost similar values. Then, a regular distribution of supporting points is themost justified.When the implant orientation is far from the optimal one, then the reaction forces are very different in various fixation points, and there is nomechanical justification for the regular joint distribution around the hernia orifice, and some fixation regions should be strengthened. • In zone 4, in the upper lateral part of the abdominal wall, the supporting points face the largest forces (see Fig. 4) and the implant orientation has the greatest influence on those forces. • The orientation of orthotropic implants (DynaMesh R O , ParietexTM andProceedTM) stron- gly influences the forces on the supporting points (up to 55%, 34% and 53%, respectively). • Placing the implant in the optimal orientation, as shown in Fig. 6, greatly reduces the forces on the supporting points, which may determine the success of hernia repair or postoperative comfort of patients. Although significant influence of the orientation of an orthotropic implant in the anisotropic abdominalwall onhernia repair persistence seems to be expected from themechanical point of view, this fact is still underestimated in surgical practice as confirmed by the newest medical conference reports and scientific papers, see e.g., Oettinger et al. (2013), Li et al. (2014). • Our results shownotonly anoptimalmeshplacement butalso results for other orientations (Fig. 4). On the basis of that, safer and less safe range of orientations can be established. Information about this range can be useful in clinical practice. Surgeons should pay atten- tion to the orientation of the implant, which currently is not a common practice, and try to avoid orientations whichmay highly increase reactions in fasteners and, in consequence, increase the risk of exceeding the capacity of tack and cause hernia relapse. • Displacement of the fasteners during regular activity influences the level of junction for- ces. As a result, the displacement of fasteners should be considered when analysing and designing the fixation of implants. These results may serve as a basis for the formulation of a relationship between the optimisation ofmesh implantation and the recurrence rate of hernias as well as they can be applied in the process of individualisation of the treatment of abdominal hernias. 420 I. Lubowiecka et al. 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Szymczak C., Lubowiecka I., Tomaszewska A., Smietański M., 2012, Investigation of ab- domen surface deformation due to life excitation: Implications for implant selection and orientation in laparoscopic ventral hernia repair,Clinical Biomechanics, 27, 2,105-110 Manuscript received May 27, 2014; accepted for print August 10, 2015