Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis
Reexamination Certificate
1999-02-25
2001-02-27
Millin, Vincent (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
C600S038000
Reexamination Certificate
active
06193753
ABSTRACT:
BACKGROUND
Existing penile prostheses include a first type which includes a device to manipulate blood flow within the penis. The most common device to manipulate blood flow within the penis is a ring or sleeve that applies constrictive pressure to the base of the penis to reduce blood flow through the veins which are located just beneath the skin of the penis. These rings or sleeves permit blood flow to enter the penis through the arteries of the penis, but restrict the flow of blood out of the penis. The accumulation of blood through the use of these devices results in many cases in an erection in the penis.
Prosthetic devices of this type have used various structures to apply a constrictive pressure on the penis, typically at the base of the penis proximate to the body. Some of the devices use sleeves which may be inflated with a pressurized fluid (typically air). Upon inflation, the sleeve expands inwardly to apply a constrictive pressure on the base of the penis. Many of these designs use inflatable bladders having inner and outer layers which are of unequal thicknesses and therefor unequal expansion rates. Specifically, these prostheses have thicker layers of material on the outside of the bladder than the inside of the bladder to encourage inward expansion of the bladder. Other prosthetic devices of this type have used a rigid body outside the inflatable bladder to ensure that inflation will provide inward expansion with the subsequent constriction of the penis.
This type of penile prostheses is commonly used when a decrease in blood flow within the penis occurs. Men who suffer from diabetes would be an example of those who would benefit from this type of prostheses.
For patients that have insufficient blood flow in the penis to create an accumulation of blood in the penis and create an erection in the penis, prostheses of this type are of little use.
A detrimental aspect of constricting prostheses of this type is the tissue damage that could be incurred if the prosthesis is left in place for an extended period of time. Were a user of this type of prostheses to fall asleep while wearing the prosthesis, serious injury would probably result.
Other penile prostheses do not encourage constriction of the penis. Theses prostheses are used primarily to add rigidity to the penis so that the user can engage in intercourse. The prostheses of this type, when used with the penis, simulate an erection. These prostheses are suitable for use by those who may have a diminished blood flow and may not achieve an adequate erection to engage in intercourse, as well as those who may have disease damaged tissue that prohibits an erection from occurring.
A first example of a penile prostheses of this type is shown in U.S. Pat. No. 3,939,827. This penile prosthesis uses a rigid splint which is placed against the penis and retained on the penis by a cover of flexible material. The cover is non-rigid and does not support the penis. The rigid splint has a shape to conform to the cylindrical shape of the penis.
A second example of penile prostheses that do not encourage constriction of the penis is shown in U.S. Pat. No. 5,522,787. This penile prosthesis uses a non-rigid support that is constructed of soft, elastic, resilient material such as cellular polyurethane which is cut into a panel to be wrapped around the penis. A semi-rigid stiffener may be used with the non-rigid support to enhance the resistance to bending of the prosthesis.
Both of the first and second examples of non-constricting prostheses offer somewhat adjustable sizing as the support or support cover is wrapped around the penis.
Neither of these supports allow for the adjustment of the rigidity or circumferential size of the prosthesis after it is placed on the penis. Actually, adjustment to the rigidity of either of these prostheses would require the use of a different stiffener in either of the examples, or require a different material to be used in the non-rigid support of the second example.
There is a need for a penile prosthesis which is suitable for use by those who may have a diminished blood flow and may not achieve an adequate erection to engage in intercourse, as well as those who may have disease damaged tissue that prohibits an erection from occurring. There is a need for this penile prosthesis to allow for the adjustment of the rigidity and circumferential size of the prosthesis after it is placed on the penis. This adjustment allows the prosthesis to adjust to the extent that a user may achieve an erection, as well as to adjust to the desired physical properties of the prosthesis for the sexual enjoyment of those who would use the prosthesis.
SUMMARY
The present invention satisfies the previously mentioned needs for an external penile prosthesis.
The external penile prosthesis comprises a support including an expandible bladder having at least first and second elastic surfaces. The first and second surfaces are secured together to include an interior expandible bladder chamber between the first and second surfaces. The prosthesis includes means to secure the support into a tube shape with the first surface providing an inside surface of the tube and the second surface providing an outside surface of the tube. The support may be secured in a tube shape of predetermined size having an inside diameter, an outside diameter, and first and second ends defining a length. The length is substantially equal to the length of a male penis from the base to the coronal ridge of the glans. The second end of the support does not extend over the glans. The tube is selectively dimensioned for a snug but not tight fit on the penis which does not cause restriction of blood flow through the veins beneath the skin of the penis.
The external penile prosthesis includes a valve for insertion of a fluid into the expandible bladder chamber. The expandible support of the external penile prosthesis may be selectively filled with fluid from a first non-expanded condition where the support has little rigidity and the support does not substantially add to the circumference of the penis, to a second fully expanded condition where the support has high supportive rigidity and adds substantially to the circumference of the penis.
The external penile prosthesis further includes means to minimize localized constriction of the inside diameter as the expandible bladder expands. Upon insertion of a fluid into the interior expandible bladder chamber, the means to minimize localized constriction of the inside diameter cause the outside diameter of the tube to expand a greater amount than the interior of the tube constricts.
Localized constriction of the tube inside diameter may be minimized substantially along the entire length of the tube. The means to minimize the constriction of the inside diameter as the expandible bladder expands comprises the first layer of the bladder having higher rigidity than the second layer of the bladder.
Alternatively, the means to minimize the constriction of the inside diameter as the expandible bladder expands comprises substantially rigid stays disposed on the first layer of the bladder for placement proximate to the penis. The rigid stays minimize the forces resulting from internal fluid pressure in the interior expandible bladder chamber from applying a localized pressure on the veins of the penis. The use of a thicker first layer in addition to rigid stays is also possible.
The support may comprise a generally planar panel having a width of predetermined size to approximate the circumference of the penis for wrapping the support around the penis. The panel includes opposite side edges which are disposed proximate to each other when the support is wrapped around the penis. The means to secure the support in a tube shape in this version may comprise a condom applied on top of the support. Alternatively, the means to secure the support in a tube shape in this version may comprise a tab of material attached to the generally planar panel for stretching across the first and second side edges to secure the side edges proximat
Nordheim Cathleen
Nordheim James D.
Johnson Jerry
Millin Vincent
Stewart Alvin
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