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    Optimization of Design and Surgical Positioning

    of Inflatable Penile Prostheses

    A. GEFEN,1 J. CHEN,2 and D. ELAD1

    1Department of Biomedical Engineering, Faculty of Engineering, Tel Aviv University, Tel Aviv 69978, Israeland 2Sexual Dysfunction Clinic, Department of Urology, Tel Aviv Sourasky Medical Center, Tel Aviv 64239, Israel

    (Received 10 December 1999; accepted 23 May 2000)

    AbstractThe interaction between the cylinders of an inflat-able penile prosthesis IPP and the surrounding tissues duringIPP-aided erection may result in local elevated stresses. Thesestresses may reach values that can obstruct penile blood vesselsand cause ischemia and/or stimulate nerves around the opera-tion site, thereby inducing sensations of pain. A new numericalmodel was used to analyze penile stresses postimplantation of

    different IPP types, in order to optimize prosthesis design andsurgical positioning by enabling minimal stress transfer to dor-sal blood vessels and nerves. The results suggest that intralu-minal pressures should be maintained at low levels about 80kPa while cylinder thickness and stiffness should be kept justhigh enough approximately 15% of the radius and 1000 MPa,respectively to eliminate deleterious cylinder-tissue contactstresses. Smaller prosthetic cylinders, i.e., occupying about45% of the cavernosal space, may be advantageous in terms ofreducing dorsal stresses, but lower penile rigidity should beexpected. A significant decrease of dorsal stresses can also beachieved by encouraging the surgeon to position the cylinderstoward the lower part of the corpora. The numerical simula-tions indicate that circular cylinders may allow greater biome-chanical compatibility of the IPP with the penis structure than

    elliptic ones, and this should be a subject for clinical investi-gations. 2000 Biomedical Engineering Society. S0090-6964 00 01106-1

    KeywordsErectile dysfunction, Impotence, Numerical

    model, Finite element method.

    INTRODUCTION

    The inflatable penile prosthesis IPP was first intro-

    duced in the early 1970s as an interventional treatment

    of impotence.14 The IPP is composed of three compo-

    nents: a reservoir that is located in the perivesical space,

    two inflatable cylinders that are surgically inserted alongthe erectile bodies of the penis i.e., corpus cavernosa ,

    and a pump that is implanted within the scrotum. When

    erection is desired, the penis can be distended to a near

    normal erectile condition by repeatedly squeezing the

    pump, thereby transferring fluid from the reservoir to

    inflate the cylinders. Manual release of the valve at the

    lower portion of the pump will cause the fluid to flow

    back into the reservoir, returning the penis to a flaccid

    state. Since this mechanism of operation mimics the nor-

    mal erectile process, it is generally accepted that the IPP

    provides the best physiological results and, accordingly,

    numerous successful IPP implantation procedures were

    performed during the last two decades.13,18 However, a

    variety of postoperative complications have been en-

    countered in up to 20% of the patients, including infec-

    tions, mechanical failures of the prosthesis, severe pain

    associated with its operation, prosthesis protrusion

    through the glans penis, and aneurysms.4,12,15

    The mechanical interaction between the artificially in-

    flated prosthetic cylinders and the surrounding penile tis-

    sues induces mechanical stresses within the penis, which

    may include sites of localized, highly elevated stresses.

    Destruction of some penile tissues during the surgical

    procedure exposes nerve endings on the internal surfacessurrounding the cylinders. Many researchers now agree

    that under these conditions, these nerve endings develop

    hypersensitivity alodynia and, therefore, their being

    stimulated by excessive stretching and/or compression of

    adjacent tissue are perceived by the patient as painful

    sensations.2,10,16 These sensations could also be aug-

    mented by obstruction of some dorsal penile blood ves-

    sels due to intensive compression, i.e., ischemic pain.

    These effects of local intensified stresses could be the

    underlying causes for penile pain during inflation of the

    prosthetic cylinders, which was clinically observed to be

    the most common cause for dissatisfaction with the

    device.6 Therefore, the biomechanical compatibility

    of an IPP can be characterized by the stresses developing

    around the primary nerve roots and blood vessels due to

    inflation of the cylinders. Gefen et al.3 recently intro-

    duced a computational model of the penis/IPP complex

    that allows for quantitative analysis of the distribution of

    stresses within the different penile tissues during IPP-

    aided erections. In the present study, we utilized this

    computational model to optimize the stresses within the

    Address correspondence to Professor David Elad, Department of

    Biomedical Engineering, Faculty of Engineering, Tel Aviv University,

    Tel Aviv 69978, Israel. Electronic mail: [email protected]

    Annals of Biomedical Engineering, Vol. 28, pp. 619628, 2000 0090-6964/2000/28 6 /619/10/$15.00Printed in the USA. All rights reserved. Copyright 2000 Biomedical Engineering Society

    619

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    penile tissues during IPP-aided erections that had been

    obtained by using different IPP structural designs with

    different surgical positions of the cylinders within the

    cavernosal spaces. Our aim was to minimize stress trans-

    fer to primary nerves and blood vessels and thereby

    alleviate some of the complications sometimes produced

    by these devices.

    METHODS

    The Penis/IPP Structural Model

    The methodology used to build a two-dimensional

    2D computational model for analysis of structuralstresses in the penile tissues during IPP-aided erection is

    described in detail in Gefen et al.;3 its essential compo-

    nents relevant to the present report are given later.

    The symmetrical geometry of a typical 2D transverse

    cross section of the human penis was extracted from an

    anatomical scheme. The model includes the following

    elements: IPP cylinders, compressed corpus cavernosa,

    tunica albuginea, skin, dorsal blood vessels, and the ure-

    thra Fig. 1 a . The corpus spongiosum, whose cross-

    sectional area is usually significantly smaller than that of

    the corpus cavernosa, was excluded. The prosthesis bulk

    and penile soft tissues were assumed to be made of

    homogenous, isotropic, and linear elastic materials,

    whose mechanical properties are detailed in Gefen et al.3

    The stress distribution was determined for each configu-

    ration by employing a commercial finite element analysis

    software package ANSYS which was used to solve the

    general equilibrium equations for plane stress. Automatic

    meshing was used to generate optimally converging

    meshes of 25003000 quadrilateral and triangular ele-

    ments that described the cross-sectional geometry Fig.2 . The meshes were determined by a converging process

    in which the mesh density was gradually increased until

    the deviation in the produced stress values did not ex-

    ceed 5%. During the meshing process, special attention

    was paid to avoid extreme transitions in sizes of adjacent

    elements, which may induce local inaccuracies in the

    numerical solution. The boundary conditions included an

    intralumenal device pressure ( P i) applied to the interior

    FIGURE 1. Biomechanical model of thehuman penisIPP complex and its adap-tation to different prosthesis designs,orientations and positioning: ad cir-cular cylinder cross sections and eh elliptic cylinder cross sections.

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    profiles of the cylinders, as well as four constraints on

    the lateral and dorsal-plantar aspects of the penis which

    allowed its expansion but not rotation in response to

    inflation of the cylinders. The finite element analysis

    provided the structural stress distribution in terms of von

    Mises (v .M.) equivalent stress

    v .M. 1

    2

    22

    121/2

    , 1

    which weighs both principal tension (1) and principal

    compression (2) effects.

    In order to characterize the biomechanical perfor-

    mances of a given IPP, we examined the averaged values

    of the stresses transferred to the dorsal nerve roots and

    blood vessels. Since the deformation of the penis during

    IPP-aided erection varies among different cases, we de-

    fined the average stress at this region as

    1S 0

    Sv.M.d, 2

    where the linear course of length S originates at the

    center of the dorsal face of the penis cross section above

    the dorsal vein and artery , crosses the dorsal nerve roots

    and the nerves of the tunica albuginea, and terminates at

    the apex of the corpus cavernosum Fig. 1 b .

    IPP Design Optimization

    The model was implemented to simulate the interac-

    tion of soft tissues of a typical penis with a series of

    inflatable prostheses that differ by their cross-sectional

    geometry, cylinder material properties, and intraluminal

    operational pressures. In addition, we tested different po-

    sitioning of the cylinders within the cavernosal spaces

    which is also likely to play an important role in deter-

    mining the distribution of stresses. Values for these pa-rameters were selected to conform to the design param-

    eters of commercial IPPs.

    Cylinder Geometry

    Two types of cylinder cross-sectional shapes, circular

    and elliptic, are presently commercially available at dif-

    ferent lengths 1028 cm flaccid , diameters 1018 mm flaccid , and wall thickness. When elliptic cylin-

    ders are considered, alignment of their principal axes

    with respect to the corporal anatomy during surgery is

    also important and was taken into consideration in this

    study.The following penis/IPP configurations were selected

    for the present optimization analysis Fig. 1 : a large

    and dorsally positioned thick circular cylinders, which

    are defined as a reference case for the comparative

    analysis; b large and dorsally positioned thin circular

    cylinders; c large and ventrally positioned thick circular

    cylinders; d small and ventrally positioned thick circu-

    lar cylinders; e large and dorsally positioned thick el-

    FIGURE 2. Examples of meshes of thepenisIPP model geometry: a and b cir-cular cylinder cross sections see Figs.1b and 1c for respective model con-figurations and c and d elliptic cylin-der cross sections see Figs. 1f and 1hfor respective model configurations.

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    liptic cylinders with an aspect ratio of 0.9 and the long

    axes directed toward the dorsal-lateral and ventral-medial

    aspects of the penis; f small and dorsally positioned

    thick elliptic cylinders with an aspect ratio of 0.9 and the

    long axes directed toward the dorsal-lateral aspect of the

    penis; g small and centrally positioned thick elliptic

    cylinders with an aspect ratio of 0.7 and the long axes

    aligned with the medial-lateral direction of the penis; and h small and centrally positioned thick elliptic cylinders

    with an aspect ratio of 0.7 and the long axes aligned with

    the dorsal-ventral direction of the penis.

    Based on measurements of commercial cylinder walls,

    thickness of a thick cylinder wall was taken as being

    15% that of the internal radius, whereas for the thin

    cylinder, it was taken as being 5% of the radius. Large

    cylinders were built to occupy 60% of the cavernosal

    space, while small cylinders occupied 45% of it. The

    earlier set of eight geometrical configurations enabled

    analysis of various IPP designs by altering the material

    properties of the cylinder walls and the intraluminal cyl-

    inder pressures, as detailed in the following paragraphs.

    Cylinder Material Properties

    Inflatable prostheses are generally made of thermo-

    plastic elastomers. Silicone rubber and Bioflex polyure-

    thane a polymer which is more durable and less elastic

    than silicone are the most common materials in current

    use.7 Since this group of materials demonstrates a variety

    of highly nonlinear stress-strain relationships, it is diffi-

    cult to establish any generalized method for determining

    characteristic material stiffness. In the present study, the

    generally accepted characterization of the Young modu-

    lus as an initial slope of the stress-strain curve was used,

    yielding elastic moduli in the range of 101000 MPa.11

    Consequently, for the present analysis, we defined soft

    (E10 MPa , medium (E100 MPa , and hard (E

    1000 MPa material types. The Poisson ratio of the

    cylinders was set as 0.4 in all cases.

    Cylinder Intraluminal Operational Pressures

    Pescatory and Goldstein12 conducted in vitro experi-

    ments with several commercial IPPs and measured mean

    intraluminal cylinder pressures between 80 and 173 kPa

    at maximum inflated volumes 1 kPa equals 7.5 mm Hg .

    These pressure values are significantly higher than the

    physiological cavernosal pressure during normal erec-tion, which is approximately 13.3 kPa.17 This difference

    appears to be mostly due to the fundamental differences

    between the behaviors of the natural anatomy of the

    penis and its structure post-IPP-implantation. In the natu-

    ral penis, internal stresses during erection are borne not

    only by the main structural framework of the penis, the

    tunica albuginea,1,5 but also by the intracavernous struc-

    ture of fibromuscular columns which penetrate the cor-

    pora and attach to the intracavernosal vasculature as

    well.12 During IPP implantation, most of this tissue is

    removed to provide space for the cylinders which be-

    come the main structural support. In order to examine

    the role of the cylinder intraluminal pressure, we simu-

    lated conditions of low ( P i80 kPa and high ( P i173 kPa inflation pressures.

    RESULTS

    The model was utilized to study penile stress distri-

    butions following implantation of an IPP in each of the

    cases shown in Fig. 1. Results are presented during full

    IPP-aided erection and in terms of von Mises equivalent

    stress Eq. 1 . Figure 3 demonstrates the resulting stress

    distributions during IPP-aided erections for dorsally po-

    sitioned thin and thick circular cylinders subjected to low

    and high intraluminal pressures. The results for each case

    are shown for only one half of the symmetric transverse

    cross-section: the cylinders made of the hard material are

    shown on the left side and those of the soft one appear

    on the right. In all cases, the tunica albuginea, which is

    considered the structural framework of the penis,5 is

    shown to be the most stress-loaded biological compo-

    nent. With the decrease in stiffness of the prosthetic

    cylinders, i.e., from hard to soft material characteristics,

    the load carried by the tunica albuginea dramatically

    increases by a factor of approximately 8 Fig. 3 a .

    Obviously, some of the elevated tunical stresses are also

    transferred to the dense network of nerves that is inter-

    laced within this structure.

    The combination of soft cylinders and high inflation

    pressures not only causes further loading of the ventral

    aspect of the tunica around the urethra , but also inducesa region of concentrated compression stresses at the cen-

    tral part of the dorsal aspect of the penis Fig. 3 b in

    the vicinity of the dorsal artery. When thin and soft

    cylinders are used, these phenomena become even more

    pronounced, as elevated compression stresses spread at

    the dorsal aspect of the penis, reaching up to the skin

    surface if intraluminal pressures are kept high Figs. 3 c

    and 3 d / . The thin cylinders also tend to lose their

    original circular cross section during inflation, eventually

    adopting an egg-shaped cross-sectional area whose local

    small-radii edge is compressed against the dorsal nerve

    roots and blood vessels. Table 1 details the results of a

    quantitative performance analysis for the circular cylin-ders when implanted at the dorsal aspects of the corpus

    cavernosa. According to the criterion of min , IPP

    cylinders ideally should be thick, made of a hard elas-

    tomer, and inflated to low intraluminal pressures. Reduc-

    tion of the cylinder thickness by 65% increased the mean

    stress values by a factor of about 2.1. Reduction of the

    Young modulus of the cylinders by one order of magni-

    tude increased the average stress values by a factor of

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    about 2.3. Alteration of the intraluminal pressure from

    low to high values also raised the stresses by a factor of

    about 1.4.

    In order to examine if the biomechanical compatibil-

    ity of circular cylinders could be enhanced by position-

    ing them as far as possible from the dorsal nerve rootsand blood vessels, we analyzed cases of large and small

    cylinders positioned lower within the corpora cavernosa,

    toward the ventral aspect of the penis Figs. 1 c and

    1 d . Analysis of the stress distributions that had re-

    sulted due to inflation of the large cylinders showed that

    positioning of the cylinders close to the ventral aspect of

    the corpora only about 4 mm lower than in Figs. 1 a

    reduced stresses at the vicinity of the dorsal nerves ()

    by as much as 20%40%, compared with the reference

    case Figs. 4 a and 4 b . Such positioning, however,

    also increased the stresses around the urethra. Use of

    cylinders with smaller diameter Figs. 4 c and 4 d not

    only effectively eliminated this problem, but also mini-

    mized the dorsal stresses to negligible levels Table 1 . Itshould be borne in mind that small-diameter cylinders

    will also have relatively less penile rigidity during IPP-

    aided erection.

    In the following stage, interaction of the penis with

    elliptic cylinders was analyzed and compared to perfor-

    mances of circular cylinders. Since the combination of

    thick walls, hard material, and low inflation pressure was

    shown to provide the best results for circular cylinders,

    FIGURE 3. Distribution of vonMises stresses during IPP-aided erection for dorsally po-sitioned circular cylinders witha thick walls subjected to lowintraluminal pressure; b thickwalls subjected to high intralu-minal pressure; c thin wallssubjected to low intraluminalpressure; and d thin wallssubjected to high intraluminalpressure. For each of the ear-lier cases, three diagrams areshown: the left one is thestress distribution for the hardcylinders, the middle one is forthe soft cylinders, and the rightone presents curves ofstresses along the line S loga-rithmic scale for both the hardsolid line and soft dashedline cylinders.

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    all elliptic cylinders were constructed using the same set

    of design parameters. Hence, the analysis of elliptic cyl-

    inders was focused on the effect of prosthesis dimen-

    sions, position, and orientation, aiming to further im-

    prove the performances of circular cylinders. The

    resulting stress distributions and prosthesis deformations

    during IPP-aided erections that were obtained by using

    the elliptic cylinders are depicted in Fig. 5. The results of

    the performance analysis for these cylinders based on

    the criterion of min ) are detailed in Table 2. These

    results clearly demonstrated that all the elliptic cylinderstested in this study generated significantly higher stresses

    at the vicinity of the dorsal nerve roots and blood ves-

    sels, compared with circular cylinders of identical thick-

    ness, material properties and intraluminal pressure.

    In an attempt to minimize stresses in the vicinity of

    dorsal nerve roots and blood vessels, large and small

    elliptic cylinders were prepositioned with the large-radii

    curve of the ellipse facing the dorsal-central surface of

    the penis Figs. 1 e and 1 f . This approach was shown

    to be unsuccessful since the poles of the elliptic cross

    section are inverted due to the nonhomogeneous resis-

    tance of the surrounding tissues during inflation of the

    cylinders. Thus, at the end of the inflation process, asartificial erection is achieved, the small-radii boundaries

    of the cylinders are directly facing toward the dorsal-

    central surface of the penis, loading the dorsal nerve

    roots and blood vessels Figs. 5 a and 5 b . This phe-

    nomenon is well reflected by the values of obtained

    for these two cases Table 2 . For instance, for the

    large inclined elliptic cylinders is as much as three times

    higher than the corresponding value obtained for the

    large, dorsally located thick circular cylinders with iden-

    tical material properties. Use of small, laterally medially

    orientated elliptical cylinders limited the inversion of the

    ellipse poles Fig. 5 c . This configuration, however,

    induced highly elevated stress sites at the medial, ventral,

    and dorsal aspects of the penis, thereby providing the

    poorest results among the set of elliptic cylinders in

    terms of Table 2 . Rotation of the cylinders so that

    their long axis aligned with the dorsal and ventral direc-

    tions moderately reduced stresses at the dorsal aspect of

    the penis, but inversion of the poles during inflation

    caused stress concentrations to appear at both lateral

    aspects.

    DISCUSSION

    It is commonly accepted that adequate mechanical

    interaction between the artificial implant and the sur-

    rounding biological tissues in vivo plays an important

    role in the success of insertion of a penile prosthesis. It

    has been shown that mechanical factors such as cylindercollapse or tissue stiffening are significant causes for

    severe penile pain due to stress concentrations and ex-

    cessive local deformations during IPP-aided erection.3,8

    Elevated local stresses and deformations may also accel-

    erate cylinder wear and malfunction in the form of an-

    eurysms or tubing fluid leaks that were reported to occur

    in 1%4% of the cases.9,15 In view of the earlier circum-

    stances which eventually require a traumatic and often

    expensive revision procedure to replace the faulty im-

    plant, it is highly recommended that both the design of

    the IPP and the surgical positioning of its cylinders

    within the penis be aimed towards minimal stress trans-

    fer to nerves and blood vessels during IPP-aided erec-tions.

    In order to optimize the in vivo performances of IPPs

    by reducing the stresses transferred to the penile soft

    tissues as much as possible, we utilized a recently devel-

    oped structural model of the penis/IPP complex. The

    model was adapted to analyze not only the effect of the

    IPP design on its biomechanical compatibility, but also

    the outcomes of surgical decisions of positioning and

    alignment of the cylinders within the corpora. The simu-

    lation of stress distributions at various postimplantation

    conditions indicated that most of the load during IPP-

    aided erection is carried by the dorsal and lateral aspects

    of the tunica albuginea, which are also the most vulner-able sites since they contain the penile nerve roots and

    major blood vessels. Our objective was to minimize

    stresses at these regions, and the results of the present

    analysis suggest that an ideal IPP could be designed to

    more closely mimic the structural behavior of the human

    penis by achieving functional rigidity at lower cylinder

    pressures and preferably at pressures that approach the

    physiological value of about 13.3 kPa . The results also

    TABLE 1. Average von Mises stresses through a

    representative section A A in the region of primary penile

    nerves and blood vessels for dorsally and ventrally

    positioned circular cylinders.

    Average stress transferred to nerves

    and blood vessels (kPa)

    Dorsally positioned cylinders

    Thin cylinder wall Thick cylinder wall

    Cylinder

    material

    E (MPa)

    Low

    pressure

    High

    pressure

    Low

    pressure

    High

    pressure

    10 176 246 128 160

    100 71 103 46 65

    1000 58 74 16 23

    Ventrally positioned thick cylinders

    Large cylinders Small cylinders

    Low

    pressure

    High

    pressure

    Low

    pressure

    High

    pressure

    1000 10 19 2 4

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    indicate that both thickness and stiffness of the cylinders

    should be kept sufficiently high 15% of the radius and

    E1000 MPa, respectively in order to eliminate large

    cylinder deformations during inflation, the result of

    which may be substantial contact stresses between the

    cylinders and the cavernosal tissue. Smaller prostheticcylinders, i.e., occupying about 45% of the cavernosal

    space, may be advantageous in terms of reducing dorsal

    stresses, but relatively less penile rigidity should be ex-

    pected. Insofar as this trade-off relation may have little

    negative effect on sexual satisfaction while it may be

    highly efficacious in avoiding the development of penile

    pains during prosthetic-aided erection, further investiga-

    tion is warranted.

    Significant decreases of up to 40% relative to the

    reference case in the mean stress values at the dorsal sensitive part was shown to result from the selection of

    a 4 mm lower position for the cylinders. Current surgical

    techniques do not allow for very highly accurate manipu-

    lation of cylinder positioning, mainly because the dilata-tors used to clear intracavernosal space for the cylinders

    during the operation are not designed to provide precise

    control of the dilatation positioning. However, based on

    the simulation results, we believe that the implanter

    should aim toward the ventral aspect, considering that

    even minimal lowering of the cylinder position would be

    highly advantageous in terms of decreasing the stresses

    within the dorsal penile tissues. This and other possible

    FIGURE 4. Distribution of vonMises stresses kPa duringIPP-aided erection for ventrallypositioned and thick-walledcircular cylinders: a large cyl-inders subjected to low intralu-minal pressure; b large cylin-ders subjected to highintraluminal pressure; c smallcylinders subjected to low in-traluminal pressure; and dsmall cylinders subjected tohigh intraluminal pressure. Foreach of the earlier cases, three

    diagrams are shown: the leftone is the stress distributionfor the hard cylinders, themiddle one is for the soft cyl-inders, and the right one pre-sents curves of stresses along

    the line S logarithmic scalefor both the hard solid lineand soft dashed line cylin-ders.

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    implications of the present findings on the surgical tech-

    nique and tools for IPP implantation should now be

    experimentally evaluated in animal models in order to

    test their validity in vivo.

    Based upon the set of configurations tested in the

    framework of the present study, it was clearly demon-

    strated that circular cylinder cross sections allow fargreater biomechanical compatibility of the IPP with the

    penis structure compared with elliptic cylinders. Inver-

    sion of the elliptic poles was observed in three out of

    four configurations containing elliptic cylinders due to

    nonhomogenous resistance of the surrounding tissues to

    inflation. This phenomenon, which not only causes dif-

    ficulties in predicting the final steady state of deforma-

    tion of the cylinders in vivo, but also induces undesired

    stress concentrations which compress nerves and blood

    vessels in the regions of the inverted poles, suggests that

    an elliptic cross section is less suitable for IPP cylinders.

    Nevertheless, clinical studies comparing performances of

    commercially available prostheses of both types in ad-

    equate numbers of patients are still required before spe-

    cific manufacturing recommendations could be estab-lished.

    Undesirable alteration of the cross-sectional shape of

    the prosthetic cylinders toward a more elliptic profile

    increases the risk for localized collapse under compres-

    sion conditions, mainly due to the effect of buckling.

    Buckling collapse commonly induces sharp geometry

    transitions within the deformed prosthesis, as demon-

    strated by magnetic resonance imaging MRI by

    Moncada et al.8 These sharp geometry transitions are

    clearly capable of inducing sites of concentrated me-

    chanical stresses within the surrounding penile tissues, in

    which mechanical failure could appear in the form of

    microtears. If some contamination of the cylinders occursduring the implantation procedure, infection will develop

    within these sites, leading to pain. Since the present

    study deals with a sterile model, the issue of infection is

    not applicable, and the discussion in the following para-

    graph is limited to the structural behavior of the penis/

    prosthesis complex.

    Buckling of an inflatable penile prosthesis during coi-

    tus may be the result of axially applied forces associated

    with initial vaginal penetration or axial compressive and

    lateral constraining forces induced by contact with the

    vaginal walls during continued intercourse. The Euler

    formula for buckling provides the critical force which

    induces buckling of a column, FbEI/L 2, where E isthe Young modulus, L is the column length, and I is the

    second moment of inertia of the column cross section.

    The buckling force is, therefore, linearly proportional to

    the moment of inertia of the column cross section. In the

    case of a circular column, the moment of inertia is IcD4/64 where D is the column diameter , while in

    the case of an elliptic column, the moments of inertia are

    Ixa3b/64 and Iyab

    3/64 where a and b are the

    TABLE 2. Average von Mises stresses through a

    representative section AA in the region of primary penile

    nerves and blood vessels for thick-walled and hard elliptic

    cylinders positioned at different alignments and subjected to

    low intraluminal pressure Pi80 kPa.

    Cylinder type and alignment (kPa)

    Large and inclined cylinders [Fig. 1(e)] 48

    Small and inclined cylinders [Fig. 1(f)] 38

    Small and laterally medially aligned cylinders[Fig. 1(g)]

    72

    Small and dorsally ventrally aligned cylinders

    [Fig. 1(h)]

    35

    FIGURE 5. Distribution of von Mises stresses during IPP-aided erection for elliptic and thick-walled hard cylinderssubjected to low intraluminal pressure: a large and inclinedcylinders Fig. 1e; b small and inclined cylinders Fig.1f; c small and laterally medially aligned cylinders Fig.1g; and d small and dorsally ventrally aligned cylindersFig. 1h. The dashed, white line marks the neutral cylindergeometry for each case flaccid mode.

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    dimensions of the ellipse on its long and short axes,

    respectively . It can be shown that for any given pair of

    circular and elliptic columns, Ic is always greater than

    min(Ix ,Iy , provided that the cross-sectional area of both

    columns is identical. Accordingly, elliptic cylinders will

    normally buckle in response to smaller loads compared

    with circular cylinders of the same cross-sectional area.

    Since the present study showed that cylinders of circularcross-sectional shape could adopt a more elliptic profile

    due to inflation, the risk of buckling and localized col-

    lapse in these cases would need to be considered.

    In order to deal with the structural complexity of the

    penis and, especially, with the lack of experimental data

    on the nonlinear behavior of its tissues, assumptions

    were made for the purposes of simplification, and this

    should be kept in mind while interpreting the results.

    Penile tissues were assumed to be isotropic and linearly

    elastic. This assumption is highly likely to be adequate

    for analysis of the tunica albuginea, which is a dense

    parallel-fibered collagenous tissue5 and is, therefore, ex-

    pected to produce a stress-strain curve with a consider-

    ably long linear part. Since the tunica albuginea was

    shown to be the main load-bearing structure in the penis,

    predictions of the present analysis could be considered

    realistic. Nevertheless, in order to estimate the effects

    of some possible nonlinear elasticity of the tunica on the

    simulation results, we replaced the tunical elastic modu-

    lus with a nonlinear constitutive law of a ligamentous

    tissue,11 which is of similar biological structure. The

    resulting stresses were greater by 10%30%, depending

    on the prosthesis type and location. In view of the ear-

    lier, experimental data that reveal the nonlinear charac-

    teristics of the penile tissues are needed. After these datahave become available, a quasilinear viscoelastic ap-

    proach could be useful to obtain a more accurate repre-

    sentation of the structural behavior of the penis.

    The computational methodology of this study presents

    powerful biomechanical tools for optimal design, devel-

    opment, and examination of penile implants to improve

    postimplantation outcomes. Implementation of this or

    similar approaches as an integral part of the engineering

    design process of an IPP may not only enhance its per-

    formances, but could also yield important surgical guide-

    lines in terms of the preferred position and alignment of

    the prosthesis within the penis. In the future, the presentapproach could be further expanded into a pre-operative

    routine for evaluation of surgical procedures for indi-

    vidual patients. In such cases, the real cross-sectional

    anatomy of a specific patient acquired by ultrasound or

    MRI will be directly incorporated in a finite element

    model. The surgical procedure can then be individually

    planned and its biomechanical consequences can be

    simulated before undertaking the actual intervention.

    CONCLUSIONS

    The present numerical simulations demonstrate that

    optimal selection of engineering designed parameters for

    the IPP e.g., cylinder geometry and stiffness can elimi-

    nate substantial cylinder-tissue contact stresses, thereby

    reducing the likelihood for postoperative complications.

    By allowing control of anatomical structural parameters,

    as well as those of the prosthesis, the methodology ofthis study could also be applied to test the biomechanical

    implications of different surgical positions of the pros-

    thetic cylinders. Hence, the use of the present modeling

    approach in the analysis of penile prosthesis implantation

    procedures significantly increases clinical and research

    opportunities by delineating what are the experimental

    studies required for the establishment of specific manu-

    facturing and medical recommendations.

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