# Patent

## Title
Malleable prosthesis with enhanced concealability

## Abstract

A penile prosthetic device comprising a column formed of resilient material. The prosthetic device comprises multiple malleable cores arranged inside the column. The multiple malleable cores are spaced apart from one another.

## Background
CLAIM TO PRIORITY
The present application claims priority to U.S. provisional patent application No. 60/981,844, filed Oct. 23, 2007, and entitled “Malleable Prosthesis with Multiple Malleable Cores Not On Center.” The identified provisional patent application is hereby incorporated by reference in its entirety.


FIELD OF THE INVENTION
The invention relates to implantable prosthetic devices. In particular, but not by way of limitation, the invention relates to implantable malleable (non-inflatable) penile prostheses.
BACKGROUND OF THE INVENTION
There are many causes of male impotence including those that are psychologically based as well as trauma related impotence. Procedures have been developed for treating impotence, and one such procedure involves the implantation of a penile prosthesis. There are two general types of penile implants, namely, the inflatable penile implant and the noninflatable penile implant. The noninflatable implants include those which incorporate a rigid rod and are permanently stiff and those formed of malleable or bendable materials and which may be bent between the erect and nonerect positions. U.S. Pat. No. 3,893,456 discloses a rigid rod type of penile prosthesis. Examples of malleable implants are shown in U.S. Pat. No. 3,987,789 and U.S. Pat. No. 4,151,841. One of the problems involved in malleable penile implants is the difficulty in concealing the device by positioning the rods in a bent configuration and remaining in that concealed position. This difficulty is often due to the large diameter of the rod. This difficulty is addressed by the malleable rod of the present invention wherein changes in the configuration of the rod provides greater positionability and concealability.
SUMMARY OF THE INVENTION
Disclosed is a prosthetic device. The prosthetic device comprises a column formed of resilient material. The prosthetic device comprises multiple malleable cores arranged inside the column. The multiple malleable cores are spaced apart from one another.
In one embodiment, the multiple malleable cores are spaced apart from a central axis of the column and are positioned adjacent an outer diameter of the column.



BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1 and 2 illustrate a prosthetic device.
FIGS. 3-8 illustrate bundles of wires in columns of resilient material.
FIGS. 9-11 illustrate examples of wire cross sections.



DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
FIG. 1 illustrates a prosthetic device 100, and FIG. 2 illustrates a cross-sectional view (along line 2-2 in FIG. 1) of the prosthetic device 100. The prosthetic device 100 comprises a column 102 formed of resilient material. The resilient material can comprise silicone or other known biocompatible resilient prosthesis material. The prosthetic device 100 comprises multiple malleable cores 104, 106, 108, 110, 112, 114, 116 118 arranged inside the column 102. The multiple malleable cores 104, 106, 108, 110, 112, 114, 116, 118 are spaced apart from one another, spaced apart from a central axis 120, and positioned adjacent an outer diameter of the column 102. In one embodiment, the multiple malleable cores 104, 106, 108, 110, 112, 114, 116, 118 are positioned in a circular pattern at equally spaced intervals as illustrated. In the embodiment shown in FIGS. 1-2, eight malleable cores are illustrated, however, other numbers of cores in a range of 3 to 9 cores are also contemplated. Each of the multiple malleable cores 104, 106, 108, 110, 112, 114, 116 118 comprises a bundle of wires as illustrated in FIGS. 3-11. In one embodiment, the wires comprise metal alloy wires formed of a malleable material. The wires can be round wires, as illustrated in FIGS. 5-7, or the wires can have an approximately hexagonal cross section (FIG. 8), fitting together with one another to substantially eliminate void spaces between wires in the bundles. Other cross-sectional shapes of wires that reduce voids between wires, including triangles (1002 in FIG. 10) and squares (1102 in FIG. 11), are also contemplated. Combinations of smaller wires fitting into voids between larger wires (902 in FIG. 9) are also contemplated. Stainless steel or other known biocompatible metal alloy wires can be used. Individual wires, or wire bundles, can be covered with braided yarn, Teflon tubing or other jacketing material to enhance mechanical characteristics.
In one embodiment, the column 102 has a central hollow core (not illustrated) that is free of elastomer. The central hollow core reduces springback. The term “springback” refers to the amount of a return movement of a bent column after a bending force is removed. Springback causes a column that is bent into a position (either a straight or bent position) to lose part of the bend after the column is released. Springback is an undesirable property that adversely affects concealability. Springback requires the user to learn to bend the column past a desired position in order for it to have the desired position after springback, or requires the user to bend the column multiple times in order to obtain a concealed position. Springback is believed to be due to the shape and elastic recovery properties of materials in the column 102, and is reduced by providing the hollow core.
As illustrated in FIG. 3, a column 302 of resilient material can be cast, molded, drilled or otherwise shaped to have multiple hollow cavities 306 into which are later inserted bundles 304 of malleable wires. In one process, the resilient material is cooled to a low enough temperature to reduce resiliency and permit drilling of the material.
As illustrated in an embodiment shown in FIGS. 4 and 7, a column 702 of resilient material can fill intermediate spaces between wires 704, 706, 708, 710, 712, 714, 716 in a bundle 718. In one manufacturing process, resilient material is injected into a mold from which air has been evacuated so that the resilient material easily flows into and substantially fills intermediate spaces between the wires 704, 706, 708, 710, 712, 714, 716 in the bundle 718 as illustrated in FIG. 7.
As illustrated in FIG. 5, a column of resilient material 502 is applied around a jacket 504. The jacket 504 surrounds a bundle 506 of malleable wires. In one embodiment, the jacket 504 comprises plastic resin tubing. In another embodiment, the jacket 504 comprises heat shrink tubing. In one process, the jacket 504 resists flow of the liquid resilient material into the bundle 506 during curing. In one embodiment the jacket 504 functions as a slip surface that reduces drag on the bundle 506 as it bends.
As illustrated in FIG. 6, a column 602 of resilient material is applied around a bundle of wires 602, 604, 606, 608, 610, 612, 614, 616, leaving void spaces (such as void space 618) between wires in the bundle that are not filled with resilient material. In one process, the void spaces are left filled with trapped air or inert gas while the column of material 602 is introduced in a viscous liquid state and then cures into a resilient state around the outside of the bundle of wires.
The penile prostheses disclosed in FIGS. 1-11 are more easily concealed and have improved rigidity (resisting buckling of the column) relative to comparable existing devices. Bending rigidity refers to the ability of a column in a straight position to remain in a straight position when subjected to radial deflection forces (bending forces) encountered during intromission. The prostheses have a desired high level of rigidity to resist bending forces in a range of smaller bending forces encountered during intromission, but also respond by bending when subjected to a range of higher bending forces encountered when the user is intentionally bending the prosthesis. The penile prostheses disclosed in FIGS. 1-11 have improved axial rigidity, in other words, resistance to buckling when a compressive load force is applied that is aligned with the axis of the prosthesis.
The malleable type penile prosthesis includes a core of multiple bundles of malleable stainless steel wire. The bundles are generally aligned with the prosthesis major axis but, instead of being in the center of the prosthesis, they are positioned radially displaced from the center, and are arranged proximate to a lengthwise side of the prosthesis. Each of the bundles comprises strands of wire wrapped around each other. A relatively small number of wires is used in each bundle. Each bundle typically includes a smaller number of wires than would be found in an axial bundle of a conventional prosthesis, and the enhanced malleability feature of the prosthesis is derived from smaller contributions of malleability from each of the bundles with smaller numbers of wires per bundle.
In one embodiment, the individual wires in the bundles are individually encased in silicone elastomer. In another embodiment, each bundle of wires is covered by a sleeve so that there is little or no elastomer in the spaces between wires in a bundle. Another variation would have no elastomer inside, just a sleeve covering the device with the wire bundles loose inside. In yet another embodiment, the wire bundles are inserted into cavities or pockets of a previously cured elastomer body, so that the bundles are free to move in the pockets, unrestrained by bonding to the elastomer body.
The outer configuration of the prosthesis can be the same as the outer configuration of conventional malleable prostheses, and known methods of implantation can be used. The wire bundles are spaced radially from the prosthesis center axis, and this outward position imparts to the prosthesis a greater resistance to bending when subjected to an externally applied turning moment (torque). The prosthesis is less susceptible to undesired bending when exposed to inadvertent low level turning moments. Because the individual bundles consist of fewer strands of wire, the bundles are more malleable and have reduced springback (elastic recovery) when the prosthesis is bent for concealment. The lower springback means the prosthesis maintains its bend and provides enhanced concealability relative to conventional prostheses.
Also contemplated is an embodiment without silicone elastomer in the center or adjacent the wire bundles. Such an embodiment would springback less when bent because there is less elastomer to provide the force to spring back, and the wire bundles would be free to bend with a larger radius, which larger radius would inherently have lower springback force.
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 implantable penile prosthetic device, comprising:
a column formed of resilient material having proximal and distal ends, and a central axis extending from the proximal end to the distal end, the proximal and distal ends having exterior surfaces that extend across the central axis; and
multiple malleable cores arranged inside the column;
wherein:
each malleable core is entirely enclosed within the column and each malleable core comprises a bundle of wires;
each malleable core is separated from neighboring malleable cores by gaps;
the resilient material fills the gaps and extends between each of the malleable cores and the central axis such that each malleable core is displaced from the central axis;
the prosthetic device is sized and shaped to be entirely implanted within a penis of a user; and
the prosthetic device is able to be bent by the user into multiple positions including a straight position, wherein the prosthetic device is sufficiently rigid to remain in the straight position during intromission, and is sufficiently malleable to maintain bent positions and not spring back to the straight position.

2. The implantable penile prosthetic device of claim 1 wherein the central axis of the column does not extend through a malleable core.

3. The implantable penile prosthetic device of claim 1 wherein the multiple malleable cores are positioned closer to an outer diameter of the column than the central axis.

4. The implantable penile prosthetic device of claim 1 wherein the multiple malleable cores are positioned in a circular pattern at equally spaced angular intervals relative to the central axis of the column.

5. The implantable penile prosthetic device of claim 1 wherein the multiple malleable cores comprise a number of cores in a range of 3 to 9 cores.

6. The implantable penile prosthetic device of claim 1 wherein each of the wires comprises a metal alloy wire formed of a malleable material.

7. The implantable penile prosthetic device of claim 6 wherein the wires are round wires.

8. The implantable penile prosthetic device of claim 6 wherein the wires have cross sections substantially reducing void spaces between wires in the bundles in comparison with void spaces present between equally sized round wires.

9. The implantable penile prosthetic device of claim 6 wherein at least one malleable core comprises a sleeve surrounding the wires and separating the sides of the wires from the resilient material.

10. The implantable penile prosthetic device of claim 1 wherein the column has a central hollow core that is free of the resilient material.

11. The implantable penile prosthetic device of claim 1, wherein each wire comprises a malleable material and jacketing material covering the malleable material.

12. An implantable penile prosthetic device comprising:
a column formed of resilient material having proximal and distal ends and a central axis extending from the proximal end to the distal end, the proximal and distal ends having exterior surfaces that extend across the central axis; and
a plurality of malleable cores, each entirely enclosed within the column, each separated from neighboring malleable cores, and each having a longitudinal axis extending along the central axis;
wherein:
the resilient material fills space between each of the malleable cores and the central axis such that each malleable core is displaced from the central axis;
the prosthetic device is sized and shaped to be entirely implanted within a penis of a user; and
the prosthetic device is able to be bent by the user into multiple positions including a straight position, wherein the prosthetic device is sufficiently rigid to remain in the straight position during intromission, and is sufficiently malleable to maintain bent positions and not spring back to the straight position.

13. The implantable penile prosthetic device of claim 12, wherein each malleable core comprises a bundle of wires.

14. The implantable penile prosthetic device of claim 13, wherein each malleable core comprises a jacket surrounding the bundle of wires.

15. The implantable penile prosthetic device of claim 14, wherein the malleable cores are angularly displaced from each other relative to a central axis of the column within a plane extending perpendicularly to the central axis.

16. The implantable penile prosthetic device of claim 15, wherein the malleable cores are arranged in a circular pattern around the central axis.

17. An implantable penile prosthetic device comprising:
a column formed of resilient material, the column having proximal and distal ends, a central axis extending from the proximal end to the distal end, and a central hollow core, the proximal and distal ends having exterior surfaces that extend across the central axis; and
a plurality of malleable cores, each entirely enclosed within the column, each radially displaced from the central axis, and each angularly displaced from neighboring malleable cores relative to the central axis within a plane that is perpendicular to the central axis;
wherein the central axis does not extend through a malleable core;
the prosthetic device is sized and shaped to be entirely implanted within a penis of a user; and
the prosthetic device is able to be bent by the user into multiple positions including a straight position, wherein the prosthetic device is sufficiently rigid to remain in the straight position during intromission, and is sufficiently malleable to maintain bent positions and not spring back to the straight position.

18. The implantable penile prosthetic device of claim 17, wherein each malleable core comprises a bundle of wires.