# Patent

## Title
Corrugated inflatable penile prosthesis cylinder

## Abstract

An inflatable penile prosthesis of the present invention includes a cylinder that has an external wall that defines a pressure chamber. That external wall preferably incorporates a number of corrugations that extend in a longitudinal direction of the cylinder. In a preferred embodiment, the external wall of the cylinder is formed of a polyurethane or of a material having a modulus of elasticity greater than that of silicone. The corrugations enable the cylinder to move from a small, deflated diameter to a much greater diameter in the inflated state.

## Background
CLAIM TO PRIORITY
The present application claims priority to U.S. provisional patent application No. 60/981,888, filed Oct. 23, 2007, and entitled “Corrugated Inflatable Penile Prosthesis Cylinder.” The identified provisional patent application is hereby incorporated by reference in its entirety.


FIELD OF THE INVENTION
The present invention relates to inflatable penile prostheses and, more particularly, relates to the configuration of the outer surface of the cylinders that form a component of the inflatable penile prostheses.
BACKGROUND OF THE INVENTION
One common treatment for male erectile dysfunction includes the implantation of a penile implant device. One type of penile implant device includes a pair of cylindrical prostheses that are implanted into the corpus cavernsae of the penis. Typically, the cylindrical prostheses or cylinders are inflatable and are connected to a fluid-filled reservoir through a pump and valve assembly. With one such type of system, one tube extends from each of the two cylindrical prostheses and connects to the pump, and one tube connects the pump to the reservoir. The pump is typically surgically implanted into the scrotum of the patient and the reservoir is implanted in the abdomen, with the tubes fluidly connecting the components. To activate the penile implant device, the patient actuates the pump using one of a variety of methods that cause fluid to be transferred from the reservoir through the pump and into the cylindrical prostheses. This results in the inflation of the prostheses and produces rigidity for a normal erection. Then, when the patient desires to deflate the prostheses, a valve assembly within the pump is actuated in a manner such that the fluid in the prostheses is released back into the reservoir. This deflation returns the penis to a flaccid state.
It is desirable that in an inflated state, the cylinders of the prosthesis expand to the greatest possible diameter, however, it is also desirable that non-inflated cylinders be of a small diameter for easier surgical implantation. These conflicting desires are addressed by the corrugated penile prosthesis cylinder of the present invention.
SUMMARY OF THE INVENTION
An inflatable penile prosthesis of the present invention includes a cylinder that has an external wall that defines a pressure chamber. That external wall preferably incorporates a number of corrugations that extend in a longitudinal direction of the cylinder. In a preferred embodiment, the external wall of the cylinder is formed of a polyurethane or of a material having a modulus of elasticity greater than that of silicone. The corrugations enable the cylinder to move from a small, deflated diameter to a much greater diameter in the inflated state.
A method of the present invention provides for expanding a penile prosthesis cylinder from a deflated state to an inflated state. The cylinder includes an external wall the defines a pressure chamber. A number of corrugations are formed in the external wall and extend in a longitudinal direction of the cylinder. The method includes the steps of: (1) providing the penile prosthesis cylinder in a deflated state in which first and second interior surfaces of the corrugations are displaced from each other a distance D measured in a radial direction; (2) increasing the pressure within the pressure chamber; and (3) reducing the distance D to a distance D′ thereby increasing the circumference and diameter of the cylinder.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a simplified side cross-sectional of an inflatable implantable penile prosthesis.
FIG. 2 is a cross section taken along line 2-2 of FIG. 1.
FIG. 3 is a cross section of the prosthesis of the present invention including longitudinal corrugations.
FIG. 4 is a magnified view of a section of FIG. 3 when the prosthesis is in a deflated state.
FIG. 5 is a magnified view of a section of FIG. 3 when the prosthesis is in an inflated state.



DESCRIPTION OF THE PREFERRED EMBODIMENTS
Various types of penile prosthesis are currently available to cure or compensate for impotence, two of which include a non-inflatable, semi-rigid implantable prosthesis and an inflatable, implantable prosthesis. The non-inflatable, semi-rigid prosthesis is implanted within the corpora cavernosa of the penis and provides a generally constant erection. The inflatable prosthesis is also implanted in the corpora cavernosa but is connected to a hydraulic pumping device. The hydraulic pumping device is located within the patient's body and is used to inflate the prosthesis for erection and deflate the prosthesis for flaccidity.
Inflatable, implantable prostheses commonly include two inflatable cylinders: one for each channel of the corpora cavernosa. FIG. 1 is a simplified side cross-sectional view of an exemplary penile prosthesis that includes an inflatable cylinder 10 formed of polyurethane and a pump 12 that is used to inflate or deflate the cylinder by pumping fluid into a chamber 14, in accordance with the prior art. FIG. 2 is a cross-sectional view of the cylinder 10 taken generally along line 2-2 of FIG. 1. The inflation of the chamber 14 results in an expansion of the diameter of the cylinder 10 or an expansion in the radial direction that is perpendicular to the longitudinal axis 16.
The polyurethane material used to form the wall 18 of the cylinder 10 has a much higher modulus of elasticity than silicone elastomers, which are used in inflatable cylinder designs produced by American Medical Systems. Unlike the cylinders that are formed of silicone, the polyurethane cylinder 10 does not require the use of an expansion-constraining sleeve to define the desired shape of the cylinder. Rather, the low modulus of elasticity of the cylinder 10 prevents the undesired bulging of the cylinder and allows it to maintain the desired shape during expansion under normal operating pressures.
However, there are disadvantages to the limited expansion capability of the polyurethane cylinder 10. For instance, in order to provide the desired large inflated state volume for the polyurethane cylinder 10, its deflated (flaccid) diameter must be large. The large diameter of the polyurethane cylinder 10 in its deflated state complicates installation of the cylinder 10 into the corpora cavernosa of the patient. Additionally, the large diameter of the polyurethane cylinder 10 in its deflated state is also uncomfortable for the patient after installation. Finally, the thin walls and the high material stiffness of the polyurethane cylinder 10 also produces very palpable sharp corners at folds in the cylinder 10, making the large deflated state of the cylinder even more uncomfortable for the patient.
Embodiments of the present invention generally relate to a corrugated inflatable penile prosthesis cylinder 20, a cross-sectional view of which is provided in FIG. 3. The prosthesis cylinder 20 is formed of a material having a relatively high modulus of elasticity as compared to the designs formed of silicone that use an expansion-constraining sleeve. One exemplary material is polyurethane, but other suitable materials can also be used to form the cylinder 20.
Cylinder 20 generally operates as described above with respect to FIG. 1. However, unlike cylinder 10 of the prior art, embodiments of cylinder 20 of the present invention include corrugations 22 formed in an external wall 24 that defines the interior chamber 26. The corrugations 22 run lengthwise or substantially parallel to the longitudinal axis 28. In one embodiment, the corrugations 22 run substantially the entire length of the cylinder 20. However, the corrugations may not necessarily be formed in the tapered ends of the cylinder 20, such as those depicted for cylinder 10 in FIG. 1.
The corrugations 22 can be formed by any suitable method. One exemplary method includes forming the mold used to produce the cylinder 20 with the desired corrugations 22.
FIGS. 4 and 5 are magnified views of the external wall 24 of the cylinder 20 approximately within circle 4, when the cylinder 20 is in a deflated state and an inflated state, respectively. The corrugations 22 can take on many different cross-sectional shapes, including the somewhat rectangular shape depicted in FIG. 4. Other exemplary shapes include more rounded or arched corrugations, triangular corrugations, and other cross-sectional shapes.
The corrugations 22 allow cylinder 20 to expand radially (i.e., in a direction that is perpendicular to the longitudinal axis 28) from the deflated state to the inflated state in response to an increase in pressure within the chamber 26. The increase in pressure within the chamber 26 can be the result of pumping fluid into the chamber 26, as described above, or other suitable method.
The deflated state of the cylinder 20 (FIG. 4) is proximate to a quiescent state of the cylinder 20, to which the cylinder 20 will naturally return from an inflated state (FIG. 5), in which the chamber 26 is pressurized. That is, any inflation of the cylinder 20 from the deflated state results in the external wall 24 being in tension. When the fluid within the chamber 26 is allowed to escape to depressurize the chamber 26, the external wall 24 will return to the deflated state shown in FIG. 4 and force the fluid out of the chamber 26.
When in the deflated state, the corrugations 22 within the wall 24 have first and second interior surfaces 30 and 32 that are displaced from each other by a distance D measured in the radial direction, as shown in FIG. 4. The distance D, or depth of the corrugations 22, is determined by the radial length of the sides 34 of the corrugations 22.
As the cylinder 20 expands radially in response to an increase in pressure within the chamber 26, the cylinder 20 reaches an inflated state that is illustrated in the cross-sectional view of FIG. 5. During the expansion, the corrugations 22 collapse resulting in a reduction to the distance D to the distance D′. The distance D′ is dependent upon the pressure within the chamber 26, the material used to form the external wall 24, and other factors.
The amount of radial expansion the cylinder 20 undergoes as a result of the collapse of the corrugations 22 depends on the number of corrugations 22 and the change in the distance D (i.e., D-D′) from the deflated to the inflated state. The more corrugations 22 in the cylinder 20, the greater the radial expansion that the cylinder 20 can undergo. The greater the change in the distance D, the greater the radial expansion that cylinder 20 can undergo.
In accordance with one embodiment, a portion 36 (indicated in phantom) in the corners of the corrugations 22 is removed or made more thin than the surrounding material to facilitate easier collapsing of the corrugations 22 and an increase in the change of the distance D during expansion of the cylinder 20 and, thus, an increase in the diameter of the inflated state of the cylinder 20.
In one embodiment, the external wall 24 of the cylinder is formed sufficiently thick to minimize the stretching of the wall beyond the collapse of the corrugations 22 under normal operating pressures.
In accordance with another embodiment, the external wall 24 of the cylinder is formed sufficiently thin to allow for radial expansion of the cylinder 20 beyond that due to the collapse of the corrugations 22 as a result of the stretching of the external wall. Thus, this embodiment of the cylinder 20 comprises a combination of the method of expansion of the conventional cylinder 20 along with that due to the corrugations 22.
Each of the embodiments of cylinder 20 discussed above facilitate providing an inflatable cylinder 20 having a smaller deflated state than prior art polyurethane or related cylinders. Furthermore, the embodiments of cylinder 20 of the present invention can provide a greater range of radial expansion over the polyurethane and related cylinders of the prior art. As a result, the cylinder 20 can have a smaller deflated diameter while providing an inflated diameter that is as large or a larger than related prior art cylinders. Thus, advantages of embodiments of the cylinder 20 over the related prior art cylinder 10 include, for example: easier installation into the corpora cavernosa of the patient, smaller flaccid diameter resulting in greater comfort to the patient, and a larger inflated diameter.
Additionally, the corrugations 22 help to soften the sharpness of bends made to the cylinder 20 when in the deflated or flaccid state. In general, when a bend in the cylinder 20 occurs there are four thicknesses of material at the bend, resulting in a larger bend radius. The larger bend radius produces a rounder, less sharp corner and results in greater comfort to the patient.
Another embodiment of the invention includes an inflatable penile prosthesis that includes embodiments of the cylinder 20 described above. Yet another embodiment of the invention relates to a method of inflating or expanding the cylinder 20.
Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

## Claims

1. An inflatable penile prosthesis cylinder comprising:
an external wall defining a pressure chamber, the pressure chamber having an inflated state and a deflated state; and
a plurality of corrugations formed in the external wall, the corrugations extending along a longitudinal axis of the cylinder, each corrugation comprising:
first and second circumferential walls extending along a circumference of the cylinder;
a first side wall extending from the first circumferential wall and along a radial direction from the longitudinal axis; and
a second side wall opposite the first side wall, the second side wall extending from the first circumferential wall to the second circumferential wall and along the radial direction;

wherein:
the corrugations each have a depth corresponding to a distance the first and second circumferential walls are displaced from each other in the radial direction; and
the depth of the corrugations when the cylinder is in the deflated state is greater than the depth of corrugations when the cylinder is in the inflated state.

2. The cylinder of claim 1, wherein the external wall is formed of polyurethane.

3. The cylinder of claim 1, wherein the diameter of the cylinder in the inflated state is greater than the diameter of the cylinder in the deflated state.

4. The cylinder of claim 1, wherein the deflated state is a quiescent state of the cylinder.

5. The cylinder of claim 1, wherein the external wall of the cylinder is placed in tension when the cylinder is in the inflated state.

6. A method comprising:
providing a penile prosthesis cylinder comprising:
an external wall defining a pressure chamber; and
a plurality of corrugations formed in the external wall, the corrugations extending along a longitudinal axis of the cylinder, each corrugation comprising:
first and second circumferential walls extending along a circumference of the cylinder;
a first side wall extending from the first circumferential wall and along a radial direction from the longitudinal axis; and
a second side wall opposite the first side wall, the second side wall extending from the first circumferential wall to the second circumferential wall and along the radial direction;


placing the penile prosthesis cylinder in a deflated state, in which the first and second circumferential walls are displaced from each other a distance D measured in a radial direction;
increasing the pressure within the pressure chamber; and
inflating the penile prosthesis in the radial direction responsive to the increasing the pressure, wherein the distance D is reduced to a distance D′ thereby increasing the circumference and diameter of the cylinder.