U.S. patent application number 10/496946 was filed with the patent office on 2005-05-26 for penile prosthesis and method of implantation.
This patent application is currently assigned to Impetus Ltd. Invention is credited to Friedman, Mark, Friedman, Svetlana, Gureyich, Vladimir, Perlin, Leonid, Yachia, Daniel.
Application Number | 20050113637 10/496946 |
Document ID | / |
Family ID | 25380089 |
Filed Date | 2005-05-26 |
United States Patent
Application |
20050113637 |
Kind Code |
A1 |
Yachia, Daniel ; et
al. |
May 26, 2005 |
Penile prosthesis and method of implantation
Abstract
The present invention is a penile prosthesis device and a
non-surgical method of implantation of the device into a penis. The
prosthesis device is designed to be an elastic mantle to be
implanted directly into the corpus cavernous cavity. The prosthesis
device contains an elongated tube plugged at both ends and fillable
with a biocompatible liquid. The liquid may be prefilled or
injected into a implanted prosthesis device to achieve the
resilience and feel of the penis. The invention includes a balloon
which is inserted into the corpus cavernous cavity and a pump is
used to pressurize the cavity and achieve a cylindrical expansion
of the form of the penis. The invention also includes an elastic
mantle having a unit including a plurality of magnets to achieve
rigidity, thereby causing the penis to become erect.
Inventors: |
Yachia, Daniel; (Herzlia,
IL) ; Friedman, Mark; (Haifa, IL) ; Perlin,
Leonid; (Haifa, IL) ; Friedman, Svetlana;
(Haifa, IL) ; Gureyich, Vladimir; (Haifa,
IL) |
Correspondence
Address: |
Martin Moynihan
Anthony Castorina
Suite 207
2001 Jefferson Davis Highway
Arlington
VA
22202
US
|
Assignee: |
Impetus Ltd
Haifa
IL
|
Family ID: |
25380089 |
Appl. No.: |
10/496946 |
Filed: |
January 6, 2005 |
PCT Filed: |
June 14, 2002 |
PCT NO: |
PCT/US02/18902 |
Current U.S.
Class: |
600/40 ;
623/11.11 |
Current CPC
Class: |
A61F 2/26 20130101 |
Class at
Publication: |
600/040 ;
623/011.11 |
International
Class: |
A61F 005/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 15, 2001 |
US |
09/882,194 |
Claims
What is claimed is:
1. A penile prosthesis device comprising: an elastic mantle shaped
in the form of an elongated tube, said tube having a suitable
length, said tube having a first end and a second end, said first
and second ends having plugs inserted therein, said elastic mantle
being placed in a trocar needle and implanted into the corpora
cavernosa without requiring a surgical procedure, and said elastic
mantle being filled with a biocompatible liquid.
2. The penile prosthesis device according to claim 1, wherein one
of the plugs includes syringe activated check valve.
3. A penile prosthesis device comprising: an elastic mantle in the
shape of a tube or balloon and having a suitable length, said tube
having a first end and a second end and each of said first and
second ends has a plug inserted therein, a unit of alternating
rigidity located in said mantle, said unit having a lock optionally
positioned using permanent magnet.
4. The penile prosthesis device according to claim 3, wherein the
unit of alternating rigidity comprises of a thin wire, having a
first end and a second end preferably said wire being selected from
the group consisting of steel, one end of said wire being attached
to the plug at the front of the elastic mantle, a plurality of
short discrete cylindrical elements each having a front part and a
rear part, each having a passage means at the axis through which
passes the thin wire, wherein the front part of an element is
coupled to the rear part of a succeeding element along the length
of the elastic mantle, and optionally an external driver means to
create a magnetic force.
5. The penile prosthesis device according to claim 3, wherein the
discrete elements of the unit with alternating rigidity have a
cylindrical form having an external diameter and an internal
diameter, said external diameter of an element having a small cut
corresponding to the internal diameter of the element having a
large cut.
6. The penile prosthesis device according to claim 3, wherein the
discrete elements of the unit with alternating rigidity comprise of
ferromagnetic material and nonferromagnetic material and said
elements are located along the wire in the form of interchanging
rows.
7. The penile prosthesis device according to claim 1, wherein the
elastic mantle has an internal surface and attached to this
internal face at the first end of the elastic mantle is a piece of
pipe.
8. The penile prosthesis device according to claim 7, wherein the
first magnet of the catch of the unit with alternating rigidity,
said magnet having a first end and a second end, said first and
second ends being attached to the inside of the pipe.
9. The penile prosthesis device according to claim 8, wherein the
second magnet of the catch of the unit with alternating rigidity,
said magnet being movable inside the pipe, said magnet being
installed coaxially with the first immovable magnet, having a first
pole and a second pole, and said magnet being adversely positioned
in relation to the first rode, with the second pole being connected
to the free end of the wire.
10. The penile prosthesis device according to claim 3, further
provided with an external driver, said external driver interacting
with the unit with the alternating rigidity via an internal
catch.
11. The penile prosthesis device according to claim 10,, wherein
the external driver comprises a third magnet, said third magnet
interacting with an internal magnet via the magnetic field.
12. The penile prosthesis device according to claim 11, further
comprising a third permanent magnet in the form of a thick-walled
pipe, said third permanent magnet and said third permanent magnet
having a diameter corresponding to the diameter of the penis.
13. The penile prosthesis device according to claim 12, wherein the
external driver is provided with an element, said element having
the properties of uncoupling the third permanent magnet from the
internal magnet.
14. The penile prosthesis device according to claim 12, wherein the
coupling element is provided with a positioning lock.
15. The penile prosthesis device according to claim 1, wherein the
elastic mantle is provided with an external arm, said external arm
being made of a material including a third non-elastic net or a
mantle and having the first and second ends attached at the
plugs.
16. The penile prosthesis device according to claim 3, wherein the
elastic mantle is provided with an external arm, said external arm
being made of a material including a thin non-elastic net or a
mantle and having the first and second ends attached at the
plugs.
17. The penile prosthesis device according to claim 1 further
including a reservoir means interconnected via a fluid delivery
means for conducing the fluid from the reservoir means to the
implanted elastic mantle.
18. The penile prosthesis device according to claim 1, wherein the
biocompatible liquid includes silicone, physiological saline oil or
a curable fluid approximating the resilience and feel of the human
penis.
19. The penile prosthesis device according to claim 17, wherein
said reservoir means and the fluid delivery means are configured to
define an integral unit.
20. A penile prosthesis device kit comprising: an implantable
elastic mantle, at least one trocar needle attachable to a fluid
delivery means, a reservoir means containing a biocompatible
liquid, said fluid delivery means and said reservoir means
configured to allow delivery of a biocompatible liquid to the
implanted elastic mantle, at least two plugs for inserting at each
end of the elastic mantle and a plurality of aseptic or alcohol
swaps.
21. The penile prosthesis device kit according to claim 20, further
comprising a unit of alternating rigidity located in said
mantle.
22. The penile prosthesis device kit according to claim 20, further
comprising a balloon provided to apply pressure and expand the
cylindrical form of the penis.
23. The penile prosthesis device kit according to claim 22, further
comprising an external driver means to create a magnetic force and
guide the unit with alternating rigidity.
24. A method of implanting a penile prosthesis device without
requiring a surgical procedure, said method comprising the steps
of: placing an elastic mantle into a trocar, inserting the
needle-catheter portion of the trocar on an aseptic portion of a
human penis, to reach the penile corpora cavernosa implanting the
elastic mantle or net into the corpora caversona cavity, and
removing the needle form the penis.
25. The method according to claim 24, further comprising the step
of delivering a biocompatible liquid into the implanted elastic
mantle to achieve the resilience human penis.
26. The method according to claim 24, wherein the elastic mantle
implanted includes a malleable rod filled with a biocompatible
material, said method comprising the step of: implanting directly
into the corpora cavernosa the pre-filled elastic mantle, and
occluding the aperture created by the needle in the elastic mantle
during filling of biocompatible material.
27. The method according to claim 24 further comprising the steps
of: inserting into the corpora cavernosa a compressible balloon
using a trocar needle and delivering pressure into said balloon to
expand the cylindrical form of the human penis before implanting
the elastic mantle.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to medical
prostheses, particularly to urological prosthe8ses and methods of
implantation for improved erectile function, and particularly to
penile implants comprising an elastic mantle, internal elements and
filling material for implanting into the corpora cavernosa, without
requiring a surgical operation, and an implantation method
therefore.
BACKGROUND TO THE INVENTION
[0002] Male impotence is wide spread worldwide. Some data indicate
that more than thirty million people between the ages of
twenty-five years and sixty years suffer from impotence in the
United States alone. A number of various methods have been used to
treat impotence, including pharmaceutical medicines such as Viagra
or Apomorphine, natural remedies, use of external apparatus and
devices to create vacuum in the penile area, implantation of
prosthesis in the penile cavity called the corpora cavernosa to
create an artificial erection, surgical implantation of penile
prosthesis filled with solution, or implantation of a drug storage
unit remote from penile tissue, but connected by a thin tubing for
delivery of vasodilating drugs such as prostaglandin E.sub.1,
papaverine, or the like.
[0003] Several prior art patents have described penile prostheses
comprising of plastic pliable elements with constant rigidity, for
example, the Semirigid and Malleable Rod Penile Prostheses, located
coaxially inside a silicon stem devices such as the Jonas
Prosthesis, Flexirod, or the AMS-600. U.S. Pat. No. 3,987,789; U.S.
Pat. No. 4,392,562; U.S. Pat. No. 4,066,073; U.S. Pat. No.
4,594,998. Disadvantageously, these types of devices are
continuously rigid and cause discomfort for the patient.
[0004] Other types of penile prostheses include surgically
positioned pumps for creating high pressure of liquid in the
elastic silicon mantle, for example, U.S. Pat. No. 5,658,329; U.S.
Pat. No. 5,803,897; U.S. Pat. No. 4,566,446; U.S. Pat. No.
4,782,826; U.S. Pat. No. 4,224,934; U.S. Pat. No. 4,235,227; U.S.
Pat. No. 4,201,202; U.S. Pat. No. 4,342,308; U.S. Pat. No.
4,009,711; U.S. Pat. No. 3,853,122; U.S. Pat. No. 3,954,102; U.S.
Pat. No. 5,062,417; U.S. Pat. No. 5,230,694; U.S. Pat. No.
5,167,611 or U.S. Pat. No. 4,267,829. Generally, the inflatable
chambers of these prostheses are situated in the corpora cavernosa,
the liquid reservoir is implanted in the inguinal area, and the
pump is situated in the scrotal sac. Unfortunately, implanting
these devices almost always requires implanting several components
into the patient's body, for example, the reservoir with liquid,
pump, several valves, connecting pipes, and the like, in addition
to those components implanted directly into the penis. Therefore,
the implantation of these elements requires complicated, surgical,
lengthy and costly procedures to be performed. Moreover, these
devices themselves are complex and expensive.
[0005] The prior art also teaches devices which use an external
source of electricity and a source of alternating magnetic field
changing with the frequency of 50 to 1000 Hz which influence the
internal element located in the penis. This element senses the
magnetic field and causes liquid in the inner reservoir to move
from the reservoir into the elastic mantles located in the corpora
cavernosa, and causes the penis to erect. U.S. Pat. No. 4,584,994;
U.S. Pat. No. 5,427,605; U.S. Pat. No. 4,491,461 and U.S. Pat. No.
5,803,897 describes a permanent magnet which makes seesaw movements
under the influence of this field. This in turn causes liquid from
the reservoir to pump into the elastic mantles, thus serving as an
internal element sensing alternating magnetic field of the external
source.
[0006] U.S. Pat. No. 5,230,694 describes penile prostheses not
containing pumps and reservoirs with a liquid, but is provided with
an internal element with alternating rigidity placed in an elastic
mantle which is closed by plugs at its side. The element is made in
the form of a spring having coils which can be moved manually from
one end of the prosthesis which is fixed to the patient's body, to
its other end, thereby causing the penis to erect. The position of
the spring's coils is fixed by the group of permanent magnets.
These magnets are in the form of stems which are parallel to one
another and are homopolarly turned to each other. The magnets' ends
touching the moving spring coils are equipped with conic bulges
which couple with the spring coils. Therefore, the magnets hold the
spring coils by their bulges by repelling each other. However, such
a construction is not sufficiently reliable. This is because it is
necessary to squeeze the magnets in order to empty the erecting
chambers. And since the magnets are located in the spring, it is
necessary to squeeze the spring in the direction perpendicular to
its longitudinal axis. The spring is highly rigid and one has to
squeeze the penis strongly from the outside using one's fingers,
which is a painful procedure. Moreover, the implantation of the
prosthesis requires similar surgical procedures as described above
for currently available penile prostheses.
[0007] Even worse, the complicated surgery may result in damage of
erectile tissues and post-operative complications. Moreover, many
of conventional mechanical prostheses have somewhat frequent
mechanical malfunction and may require additional surgery to
replace the prosthesis. Nevertheless, about twenty thousand such
surgical operations are performed each year in the United States
alone.
[0008] The drawbacks of the current methods of implantation and
above devices are that, independently of the type of prosthesis and
components used, these units are implanted into the penis by means
of conventional surgical operation, by making a surgical cut in the
area of the penile skin, corpora cavernosa or the scrotum for
implanting the prosthesis. Such surgical operations are complex,
expensive and inconvenient.
[0009] It is therefore an object of the invention to provide a
non-surgical, non-intrusive penile erection device, and which
reduces the pain associated with mechanical malfunction of
devices.
[0010] It is also an object of the invention to provide an
implantation procedure for penile prosthesis, which procedures
requires no surgery, and can be carried out in an outpatient
clinic.
SUMMARY OF THE INVENTION
[0011] The present invention overcomes the problems associated with
previous devices and implantation methods by preferably implanting
a penile prosthesis without requiring a complicated surgical
procedure thereby making the procedure cost-effective and possible
in an outpatient setting.
[0012] The penile prosthesis device of the present invention
includes an elastic mantle in the shape of a balloon or tube, the
mantle is plugged at each end and is filled with a biocompatible
liquid. The prosthesis device is inserted into the cavernous cavity
by means of a trocar, and requires no surgical procedure.
[0013] An additional embodiment of the invention includes a
prosthesis unit having alternating rigidity and a catch for locking
its position using a plurality of permanent magnets. The prosthetic
device unit having the alternating rigidity comprises a thin wire,
preferably made of steel, and a plurality of short discrete
cylindrical elements. Each of the cylindrical elements further
includes an axis hole through which passes the above-mentioned
wire. The elements are coupled to each other end to end.
[0014] In another embodiment of the invention, every discrete
element of the unit with alternating rigidity is made in the form
of a cylinder with the alternating cut done in such a way that the
outer diameter of the front of the minimal cut corresponds to the
inner diameter of the front of the maximal cut.
[0015] In yet another embodiment, the discrete elements of the unit
with alternating rigidity are made of ferromagnetic and
non-ferromagnetic material and are located along the wire in the
form of interchanging rows. One of the ends of the wire is attached
to the plug at the first end of the elastic mantle. A part of the
rigid pipe attached on the inner surface of the elastic mantle near
its second end, is injected into the prosthesis.
[0016] In a different embodiment, the first magnet of the catch of
the unit's position with alternating rigidity is attached by one of
its ends or poles to the inside part of the rigid pipe. A second
magnet of the catch of the unit's position with alternating
rigidity and is attached by one of its ends or poles to the inside
part of the rigid pipe, coaxially with the first fixed magnet, and
is turned to it by its opposite end, the second end or pole of
which is connected with the free end of the wire. The prosthesis is
equipped with an external driver interacting with the internal
catch of the unit. The external driver is made in the form of a
third permanent magnet which interacts with the internal movable
magnet by means of the magnetic field. The third magnet is in the
form of a heavy walled pipe and an inner diameter corresponding to
the size of the penis. The external driver is equipped with an
element for uncoupling the third permanent magnet and the internal
movable magnet.
[0017] The uncoupling element is made in the form of a
ferromagnetic pipe which is inserted into the inner hole of the
third magnet, and is able to move on the axis while the conjugated
surfaces of the ferromagnetic pipe and the magnet are covered with
a material such as Teflon, that provides a suitable drag
coefficient. The uncoupling element further has the catch of
position as described in detail in FIG. 6 for an uncoupling element
used for two opening halves with a faster. Additionally, the
elastic mantle may be equipped with an external arm made of thin
non-elastic net attached at its ends to the plugs. The elastic
mantle may also have a syringe activated check valve attached in
one of the pipes. These particular characteristics in the
construction of the penile prosthesis in the present invention,
enable it to work reliably since the position of the unit
influences the catch by means of the magnetic field of the external
magnet, without deforming the penis and the internal elements of
the prosthesis.
[0018] Additionally, the penile prosthesis unit with the
alternating rigidity and its catch enable the prosthesis to reduce
to its original state or in the non-erectile state. In this state,
the prosthesis can be inserted with ease into the corpora cavernosa
by a trocar like larger caliber needle, thus avoiding the need for
surgical procedures involving incisions, as is the case now, when
implanting a penile prosthesis.
[0019] An additional aspect of the present invention is the method
of implantation of the semirigid, malleable, rod penile prosthesis
and the like. For example, by implanting into the penis separately,
the elastic mantle with inside elements and the filling material,
using a needle-shaped catheter directly in to the penile corpora
cavernosa, without making a surgical incision. Optionally, the
elastic mantle may be partially pre-filled, or the filling material
may be inserted into the elastic mantle already placed in the
corpora cavernosa, through a needle catheter and valve. The filling
material may include standard physiological solution, biocompatible
elastomer, silicone, oil, or other material in liquid form. This
material may cure or harden after filling. Before insertion of the
elastic mantle into the corpora cavernosa the implantation method
may include a step of expanding the cavity by using a high-pressure
balloon, similar to angioplasty balloons.
[0020] A further benefit of the implantation method of the present
invention is the minimum erectile tissue disruption created by
insertion of the unfilled or partially filled elastic mantle
directly into the corpora cavernosa of the penis. The elastic
mantle may be filled with small diameter elements, such as
malleable rods or other elements of similar diameter, through a
needle-catheter approximately 2.5 to 6 mm in diameter, preferably 4
to 4.5 mm in diameter, without making a surgical incision in the
penis.
[0021] After its insertion, the mantle is filled with a sufficient
amount of a liquid which may or may not be self-curing. Filling the
mantle is done through a valve, either by a needle catheter or by a
smaller caliber needle. If a self-curing biocompatible elastomer,
for example, silicone or the like, is inserted, its curing time
after its injection into the elastic mantle is predetermined. The
creation of the intracorporeal cavity for the elastic mantle by
using a longitudinal high-pressure balloon allows the elastic
mantle to reach a smooth cylindrical form upon filling with the
biocompatible material.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 presents the drawing of the implanted penile
prosthesis in the condition in which it is implanted in to the
penis.
[0023] FIG. 2 shows the process of implantation of the prosthesis
into the penis through a trocar.
[0024] FIG. 3 shows the process of filling the implanted prosthesis
by a biocompatible liquid through a valve at the distal tip of the
erectile chamber.
[0025] FIG. 4 shows the drawing of the prosthesis filled by a
biocompatible liquid.
[0026] FIG. 5 shows the drawing of the prosthesis implanted into
the penis, with the magnet put onto penis influencing the catch of
the position of the element with alternating rigidity. The element
with permanent rigidity is in the condition of the maximal
rigidity, while the penis is erected.
[0027] FIG. 6 shows the construction of the external magnet
consisting of two opening halves.
[0028] FIG. 7 shows the construction of the external magnet
provided with the collapsible magnetic shield and the lock.
[0029] FIG. 8 presents the fragment of the unit of alternating
rigidity.
[0030] FIG. 9 illustrates the process of insertion of the unfilled
(or partially filled) elastic mantle with the pre-installed
malleable rod into the penis through a needle-catheter entering the
tip of the corpus cavemosum.
[0031] FIG. 10 shows the process of filling the elastic mantle
located inside the corpus cavernosum by physiological solution or
by a self-curing biocompatible liquid elastomer.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0032] According to the invention, the Implanted Penile Prosthesis
(FIG. 1) contains the elastic mantle 1 made of a biocompatible
elastic material such as medical grade silicone elastomer, in the
form of a pipe with plugs 2 and 3 at its ends, as well as the unit
with alternating rigidity, made in the form of flexible wire 4,
preferably made of medical grade stainless steel passing through
the discrete elements 5 put on it. Discrete elements 5 include
polyetheretherketone (PEEK) or polyetherimide (PEI). The front part
of each element (5a) is conjunct with the rear part of each
subsequent element (5b) (FIG. 8). These elements can have the form
of short cylinders with alternating cut made in such a way that the
outer diameter of the front of the less cut corresponds to the
internal diameter of the front with larger cut. Beside this, the
discrete elements 5 can be made of ferromagnetic (5a) and
non-ferromagnetic (5b) materials located along the wire 4, in
interchanging rows. Bonding elements include ultra-violet cured
adhesives.
[0033] Plug 3 has a syringe activated check valve 6 for filling
through it the mantle 1 by a biocompatible liquid 7 (FIG. 3). One
end of the flexible wire is fixed to the distal plug 3, the other
end is connected with movable magnet 8. This magnet can be moved in
a piece of the a rigid pipe 9 attached to the plug 2. It is
directed toward the movable magnet 8 by its inverse pole and is
fixed to the end of the rigid pipe 9 (FIG. 4). The device has also
an external driver 8. This driver is made in the form a permanent
magnet 11 (FIG. 6), in the form of a cylinder. The internal
diameter of the magnet 11 is chosen in such a way that the magnet
can be freely put around and removed from the penis after an of
erection is achieved (FIG. 1). Magnet 11 is equipped by the
uncoupling element with the movable magnet 8 providing changes of
magnetic connection between them. This can be provided by means of
making magnet 11 in the form of two detachable halves provided with
a lock 12 (FIG. 6), or by means of an additional ferromagnetic
shield 13 (FIG. 7) of cylindrical form, which can be moved
coaxially in magnet 11 and is provided with a lock 14. The
permanent magnets comprise of a metal alloy Nd--Fe--B coating with
parylene.
[0034] The Implantable Penile Prosthesis is inserted into the
corpora cavernosa 15 of the penis 16 through a trocar 17 (FIG. 2)
in the state when the elastic mantle 1 is not filled with the
biocompatible liquid. After implantation of the prosthesis into the
corpora cavernosa, the elastic mantle 1 is vacuumed, and further is
filled with the biocompatible liquid by means of the injector 18.
The elastic mantle 1 gets larger in its size and fills the cavity
of corpora cavernosa. Since this cavity can be of irregular form,
the elastic mantle 1 can be provided with the external non-elastic
arm 19 made in the form of the net or mantle freely put in the
initial position on the elastic mantle 1 and attached to its both
sides are plugs 2 and 3. The non-elastic arm comprises of an ultra
thin polyester tubing or net. The arm can be freely expanded
together with the elastic mantle reaching the maximal diameter of
corpora cavernosa. Then it prevents the elastic mantle from further
deformation keeping its cylindrical form.
[0035] In flaccid penile position, the magnets do not touch one
another and wire 4 with the discrete elements 5 is in its free
state (FIG. 4).
[0036] In order to create an erection, it is necessary to put the
external magnet 11 next to the penis in the position illustrated in
FIG. 6 or 7. The magnet should be moved in the direction of the
body. By means of the magnetic field, magnet 11 gets coupled with
the movable magnet 8 causing it to move synchronically in the pipe
9, till it touches the immovable magnet 10. While moving, the
magnet 8 tightens the wire 4 with the discrete elements 5, and also
pulls together the fronts of the elastic mantle 1. The discrete
elements move toward search other until their conjugated surfaces
meet, thus forming a rigid construction. The general rigidity of
the prosthesis sufficiently grows, and the penis becomes erected.
The state of magnet 8 (and consecutively of the entire prosthesis)
is fixed due to attraction of magnets 8 and 10. After that, the
magnetic connection of the external magnet 11 with the movable
magnet 8 is interrupted by meads id uncoupling the magnet's halves
(FIG. 7). Then the remove magnet 11 is removed from the penis. To
get into the initial flaccid states, it is necessary to put the
remote magnet 11 on the penis, to restore connection between magnet
11 and the movable magnet 8, and to move magnet 11 towards the
penis's end, drawing the movable magnet 8m as well as the
ferromagnetic discrete elements 5, which one by one are get out of
coupling with non-ferromagnetic elements. In this case, all
elements of the construction are returned into their initial state,
providing for returning the penis to the flaccid position.
[0037] The described construction provides a reliable functioning
of the penile prosthesis and makes the conventional surgical
implantation unnecessary, thus resulting in a simpler and less
costly process of implantation.
[0038] According to the method of the present invention, the
elastic balloon (which can be supplied with reinforced walls)
predetermining its inflated shape 3 usually made of silicone
elastomer or other biocompatible material with some physical
properties (FIG. 1) is inserted into corpora cavernosa 1 of the
penis 2 through a needle-catheter 4. In its insertion the balloon 3
can be empty or partially filled by a physiological solution 5, or
by a self-curing biocompatible liquid material mixture (as
silicone, for example). Semirigid or malleable rods 6 or other
elements of the construction can be pre-installed into the balloon
3.
[0039] After inserting the balloon 3 into the corpora cavernosa, it
is completely filled (FIG. 2) by the physiological solution 5 or by
a self-curing biocompatible liquid material mixture. The balloon
can be filled by means of the syringe 7 through a needle 8 inserted
through a valve 9.
[0040] If the balloon is filled with a physiological solution,
after retrieval of the injection needle the prosthesis will mimic a
natural erection. If a self-curing biocompatible liquid material
with predetermined curing time is injected, after solidification of
the material the prosthesis will mimic a natural erection.
[0041] In order to allow an even and cylindrical expansion of the
balloons, before their insertion into the corpora cavernosa, the
corporal cavities can be expanded by using a high pressure balloon
(similar to angioplasty balloons) inserted into the corpora
cavernosa through the above mentioned needle catheter. The
pre-creation of the intra-corporeal cavity to host the elastic
mantle by using a longitudinal high-pressure balloon allows to fill
the elastic mantle and obtain a smooth cylindrical form
prosthesis.
[0042] The described method of the prosthesis's implantation
enables to avoid surgical incisions to the penile tissues, thus
reducing the cost of the implantation and diminishing the risk of
post-operative complications.
* * * * *