Note: Descriptions are shown in the official language in which they were submitted.
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In some instances of erectile impotence in which
the patient does not respond to more conventional therapy,
the surgical implanting of a penile prosthesis may be the
only practical means of remedying the impotency.
In the past, several types of penile prostheses have
been employed. The first type is a rod oE suitable stiffness
which is surgically implanted into the corpus cavernosum of
the penis. The major disadvantage of the rod-type implant
is the permanent stiffness of the rod which can be a source
; 10 of physical pain as well as embarrassment to the patient.
The other type of penile prosthesis which is available
is the inflatable prosthesis. The most common inflatable
prosthesis includes two fairly long inflatable tubes that
are surgically implanted in the corpus cavernosum of the
penis. Each of the two tubes is connected by tubing to a
pressure bulb of inflating fluid which is implanted elser~here
in the body. Because of the volume required to pressurize
and rigidize the inflatable tubes, the pressure bulbs are
relatively large.
Ano-ther inflatable penile prosthesis has two implants
each having its own relatively large pressurizing bulb which
is surgically implanted in the scrotal sac. The penile implant
includes a non-distensible stem portion made of a relatively
stiff silastic material which supports the implant and an
integral collapsible bag-like distensible portion which is
implanted into the cavernosum of the pendulus penis.
Inflatable implants currently available must be
inflated periodically to prevent the scar tissue capsule which
forms a~out the implant from bridging folds in the abric
of the inflatable or distensible portion and preventing the
implant from becoming fully inflated~
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It is tlle general object of the present invention to disc].ose a
superior inflatable penile prosthesis.
The present invention provides a penile implant comprising: ~a)
an elongated, flexible rod of physiologically inert Material having a
relatively short proximal portion adapted to be inserted into the root end
of the corpus cavernosum of a penis, and a longer distal portion adapted to
be implanted in the corpus cavernosum of the pendulus penis; [b) a sleeve
- axially positioned about an intermediate section of the distal portion of
~:~ said rod and sealed at each end of the rod to form an elongated pressurizable
chamber; (c) a pressure bulb for pressurizing fluid for said chamber; (d)
means connecting the chamber and the pressure bulb so that pressurizing fluid
can be introduced into and removed from the chamber; and (e) valve means for
controlling the flow of fluid.between the chamber and the bulb. In a
preferred form of the invention, there are two separate penil implants each
having its own separate pressure bulb which is adapted to be implanted into
the scrotal sac.
; The short, proxlmal portion of the flexible rod of the implant
is preferably relatively stiff and, when impanted into the root end of the
corpus cavernosum, anchors and supports the implant. The longer distal
~: 20 portion of the rod may be relatively soft and more flexible than the proximal
portion. A more flexible, soft distal portion of the rod causes a minimum
of irritation to the tissue of the penis and permits the pendulus penis to
assume a normal. position when the implant is not inflated. In a preferred
embodiment, the tip of the distal portion of the rod is paraboloidal in
shape to
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fit the end of the corpus cavernosum, and to enhance the
physiological compatibility of the implant.
The relatively small volume cha~ber which is formed
by sealing the ends of the axially positioned cylindrical
sleeve to and about the rod normally contains residual
pressurizing fluid and it can be further pressurized with a
small amount of fluid from the pressure bulb to rigidize the
implant and to affect a penile erection. The presence of the
rod in the chamber also effectively prevents the transfer of
too much fluid back to the pressure bulb. The portion o
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the flexible rod which extends through the pressurizing ,
chamber also prevents the fabric of the sleeve which forms
the outer wall of the chamber from forming deep folds when
the implant is deflated. The scar tissue of the capsule
which surrounds the implant otherwise could bridge such
folds preventing the implant from becoming fully inflated
when later pressurized.
Brief Description of the Drawings
. .
- Fig. 1 is a partial sectional view of the penile
prosthesis of thepresent invention in a depressurized
condition as surgically implanted in a male;
Fig. 2 is a cross sectional view taken along the
lines 2-2 in Fig. 1;
Fig. 3 is a view similar to Fig. 1, except the
prosthesis is fully pressurized;
Fig~ 4 is a view taken along line 4 4 in FigO 3;
and
~ Fig. 5 is an enlarged vlew of a preferred sleeve
`~- fabric.
As seen in Figs. 1-4, the penile implant 10 comprises
an elongated rod 11 of a physiologically iner~ material such
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as medical application sillcone rubber. The rod ll has a short,
proximal portion 12 of relatively stiff material which is
implanted in the root end of the corpus cavernosum to support
and anchor the implant, and a longer distal portion 13 of a
softer, more flexible material which is implanted into the
corpus cavernosum of the pendulus penis. The distal portion
13 has a tip 14 which is paraboloidal in shape to conform to
the inner shape of the end of the corpus cavernosum.
Positioned axially about an intermediate section of
the distal portion 13 is a sleeve 15 of silicone coated fabric
which is sealed at its ends 16 and 17 to the rod in a fluid-
tight manner to form a cylindrical chamber 18 for pressuriziny
fluid. The seals between the ends 16 and 17 of the sleeve 15
and the rod ll are preferably made with a suitable silicone
adhesive~
Referring to Figs. 1 and 3, it can be seen that
communication between the chamber 18 and a pressure bulb
; assembly 19 containing a pressurizing fluid 20, such as saline
is provided by a length of silicone rubber tubing 21. ~he
pressure bulb assembly 19 which is implanted in the scrotal
sac includes a pressure bulb 22 and a valve 23 for controlling
the flow of pressurizing fluid 20 between the pressure bulb 22
and the chamber 18. The valve means 23 is preferably a
normally closed valve which is opened manually be squeezing
the valve body or the pressure bulb and which can either be
closed by additional manipulation or which although not
completely closed delays the return of fluid to the bulb for
a suitable period of -time.
Referring specifically now to Fig~ l, it can be
seen that when the chamber 18 of the implant is depressurized
the soft, relatively flexible distal portion 13 of the rod ll
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permits the penis to assume a substantially normal, flaccid
position. As seen only in Fig. 2, the chamber 18 contains
a small amount of residual fluid 20 even when the implant 10
; is depressurized. The residual fluid 20 within the chamber
18 cooperates with the rod 11 to keep the fabric of the
sleeve 15 from forming deep folds into which the scar tissue
of the capsule which forms about the implant 10 can grow
to interfere with the later expansion of the chamber.
Referring now to Figs. 3 and 4, it can be seen that
when the penile implant 10 is pressurized the chamber 18 is
filled and distended by pressurized fluid 20 and the soft,
flexible distal portion 13 of the rod 11 is supported by the
pressurized sleeve 15 so that the penis assume a substantially
normal erectile form.
As seen in the drawings in both its depressurized and
pressurized states the proximal portion 12 of the penile implant
10 is anchored in the root end of the corpus cavernosum, and
the paraboloidal tip 14 is positioned in the glans end
of the corpus cavernosum. As a result~ the implant 10 is at
all times positioned correctly in the corpus cavernosum of
the penis and the likelihood of displacement is minimized.
Although in the drawings a single penile implant 10
is shown, the complete penile prosthesis will normally
include two separate penile implants each having its own
- pressurizing ~ulb which is surgically implanted in the
scrotal sac
The unique construction of the penile implant of
the present invention which includes an intermediate section
of the distal portion of the rod 11 within the chamber 18
minimizes the amount of fluid 20 needed to pressurize and
regidize the lmplant 10. As a result, the pressure bulbs
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22 can be relatively small in size, approximately 10 to 15
cc in volume, and thus, can be conveniently implanted in the
scrotal sac, if desired, replacing the testes.
The pressure bulb 22 which is of flexible resilient
material can be provided with a small, integral resealable
valve (not shown), if desired, so that additional fluid can
be added to the pressure bulb 22 with a hypodermic needle
after the bulb 22 has been implanted.
; To effect a penile erection, the chamber 1~ of a
~ 10 properly implanted prosthesis is filled by forcing pressurizing
; fluid 20 from the pressure bulb 22 through the valve 23 via
the tubing 21 into the chamber 18 formed by the rod 11 and
sleeve 15. The pressurizing fluid 20 fills the chamber 18
and stiffens the penis adequately for sexual intercourse. ~ `
When it is desire to depressurize the implant 10, the
pressurizing fluid ~0 is permitted to drain from the chamber 19 ;~
back via the tubing 21 through the valve 23 into the pressure
; bulb 22~ Once an adequate amount of fluid 20 has been
returned to storage in the pressure bulb 22 the penis is flaccid
and the patient can engage in activities without fear of
embarrassment of pain.
In the foregoing description, the proximal portion
12 of the rod 11 has been described as being stiff whereas
the distal portion 13 has been described as being relatively
flexible. While the term '1stiff" has been used to describe
the desired physical properties of ~he material of the rod,
a more precise and technical term is fle~ural modulus, which
is the ratio of applied force to resulting deflection. How-
ever, most tables of properties do not descrlbe the stiffness
properties of rubber or rubber-like material 4 However~ they
do list related properties such as hardness.
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Hardness is measured by a durometer such as a Shore
A durometer which ascertains the depth of penetration of a
specific indentor into a specimen under specified conditions.
A scale is chosen 50 that 9 represents a material showing no
measurable resistance to indentation and 100 represents a
material showing no measurable indentation.
;~ In the preferred embodiment of the invention, the
proximal portion 12 of the rod 11 has a Shore hardness of
about 70, the distal portion 13 has a Shore hardness of
about 20, and the material has sufficient tensile strength
for its intended use. Although a material of the described
characteristics is preferred~ any material which performs
satisfactory under conditions of use can be employed.
The rod 11 is preferably molded as a single piece or
the distal and the proximal portions can be ~oined by a hinge.
The stiffness of a silicone rod can be controlled by the type
and amount of catalyst used to cure the elastomer and the
amount of heat and time employed during the curins or
;~ vulcanizing process.
The rod 11 may take other form than that described.
For example, the rod may instead of being a solid silicone
piece be a cylinder of sponge or foam, with or without
reinforcement. Thereforel the word "rod" as used in the
specification and claims is intended to cover any structure
functionally eq~ivalent to that described for purposes of
illustration.
The sleeve 15 is preferably made of a silicone
elastomer coated woven or knit fabric which provides to a
limited predetermined expansion to allow the penis to
become longer and to contain the pressure so that the tunica
albuginea will not distend. A preferred form of woven fabric
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is shown in Fig. 5. As seen in the drawing, the axial threads
24 of the fabric are normally crimped and the lo~gitudinally
extending threads 25 are straight. A silicone coated fabric
of this design wlll expand to a limited extent axially and not
expand longitudinally~ Alternatively, the sleeve 15 also
can be made of a material which does not distend either
axially or longitudinally.
The diameter of the sleeve 15 is preferably such
that the rod 11 fills the major portion of the chamber 18.
Therefore, even when the implant is depressurized and the
~; sleeve is of the nonexpanding fabric, the rod 11 will cooperate
with the small amount of residual fluid 20 which remains in
the chamber 1~ to prevent deep folds from forming in the fabric
of the sleeve. The use of a sleeve material which does not
distend or distends only to a limited extent makes is possible
~ to raise the fluid pressure in the sleeve to the desired high - -
,~ level with only a minimum of pressurizing fluid. Therefore,small volumepressure bulbs which can be implanted in the
scrotal sac can be usedO
The preferred method of implantation of implant 10
is througll the perineum. After appropriate incision, the
corpus cavernosum is dilated distally and proximally to
, accept the implant. The appropriate anatomical measurements; are made to insure that the proximal portion 12 of implant
10 will be positioned at the base of the penis below the
pelvic bone. An implant having an appropriately sized
distal portion 13 is obtained and the distal portion inserted
into the corpus cavernosum of the penis~ The proximal portion
1~ of the implant 10 is cut to the appropriate length. During
the manufacture of implant 10 the length of proximal portion
12 may be deliberately made lon~er than necessary thereby
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permitting it to be trimmed to the correct length at the time
of surgery. Only one implant of each distal portion length
need, therefore, be available since other anatomical size
variations may be accommodated by trimming proximal portion
12. This greatly reduces the number of implant sizes which
must be produced over that which would be required i~ no
such size alteration were possibleO
I Proximal portion 12 is inserted in the dilated crus
;~ a~ter trimmin~. The incision is then closed. The identica]
procedure is formed on the other side of the penis to complete
the surgical procedure. Distal portions 12 of the two implants
may diverge laterally to accommodate the anatomy and provide
lateral stability to the penis.
In the preferred embodiment, all the paxts and
components of the prosthesis are made of medical application
silicone rubber which is non-reactive r non-toxic and well
tolerated by the adjacent organic tissues. Silicone rubber
is preferred because it i6 quite resistant to wear and tear
and remains functional ~or long periods of time. However,
other suitable materials may be employed, if desired.
It will be readily apparent to those skilled in the
art to which this invention relates that a variety of changes
and modificAtions might be made without departing from the
; spirit and scope of the invention.
For example~ although in the drawings the tubing 21
is shown as passing through the rod 11 and emptying directly
into the chamber 18 other constructions may be employed.
For instance/ the intermediate portion of the rod 11 within
the chamber 18 could be provided with a central bore and wall
openings that communicate with the bore and chamber so that
the tubing 21 could communicate directly with the bore and
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indirectly with the chamber. Another modification that
could be made would be to have the tubing ?l not pass ~hrough
the body of the rod 11, but communicate with the chamber 18
through a port in the wall of the sleeve 15.
Furthermore, if desired, the sleeve 15 may take the
initial ~hape of a curved tubular member as opposed to the
cylinder described and shown in the drawings. The forming
of a curved tubular sleeve in approximately the shape that
the sleeve assumes when the implant is in the depressurized
state further minimizes the likelihood of folds forming which
can be encapsulated by scar tissue. However, in order to ~-~
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permit the curved tubular sleeve to assume the shape of a
cylinder upon pressurization, it may be necessary to have
selected longitudinal threads of the woven or knit fabric
of the sleeve crimped to permit a limited longitudinal
extension.
From the foregoingt it will be apparent that the
description has been for purposes of illustration and is
not intended to be limiting.
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