ann_bme_28_619-628
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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
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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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