United States Patent:   6,007,836

Assignee:  Vericade, Inc. (Melville, NY)

Filed:  May 19, 1998

A vasodilator delivery system is provided for producing and maintaining the erection of a male penis during intercourse. The vasodilator is contained in a transdermal patch. The transdermal patch comprises a thin, smooth-edged layered structure for dispensing a suitable vasodilator to the penis skin surface. In each embodiment of the patch, a vasodilator is applied to the skin of the user and is sealed against unwanted contraindicated leakage and contact with the internal tissues of a sex partner.

SUMMARY OF THE INVENTION

In addition to embodiments used inside of a condom, the present invention comprises embodiments used outside of a condom, and thus requiring no condom at all. The non-condom embodiments will be referred to simply as embodiments. Those embodiments used in combination with a condom, and thus requiring a condom, will be referred to as condom-embodiments.

As a means of consistently describing the features of the present invention, the adhesive itself will not be termed a layer in and of itself. Rather, adhesives will be discussed in the present invention as being coated upon or applied to surfaces comprising the patch. The layers of the patch of the present invention will be described in detail, however.

In this invention, the term `inside` will be used to describe surfaces facing or closest to the skin of the user. The term `outside` will describe those portions of the invention which are furthest from the skin of the user, or face away from the skin of the user. Thus, for example, the outer layer of a 3-layer patch is the layer which, when the patch is in use adhered to the skin of the user, is disposed farthest from the skin of the user.

However, each of these layers are not limited to a single layer. For example, the outer layer may be an outer protective barrier layer to prevent abrasions or tearing of the patch, and this at least one outer layer may be covered by a further outer layer, such as a water repellent layer.

The term barrier layer will also be used in this invention to describe the at least one outer layers of the patch since this at least one outer layer comprises an impermeable barrier sealing the vasodilator materials under it and within the confines of the patch. Here the term "under" as `in under the barrier layer`, is used to mean between the barrier layer and the skin of the user, and the term `under` does not necessarily connote a vertical disposition as used in this context.

Also for example, each of the same aforedescribed at least one outer layers will have two surfaces--an outer surface and an inner surface. The inner surface of each of the outer layers, for example, is the surface of each of the outer layers which faces toward the skin of the user.

All of the following embodiments of the present invention, that is, the non-condom-embodiments and the condom-embodiments, are similar in several ways. They are constructed of suitably thin and flexible materials, so as to be able to bend and conform comfortably with the movement of the surface of the skin.

The transdermal patches are constructed of one or more layers, so that each patch presents at least one edge to the skin of the user. The at least one edge results from the fact that the patch can have a round tabular shape, and thus would have at least one edge. The patch can have any tabular shape, such as a square, oblong or oval, in which case the patch could have more than one edge. The shape of the patch is not critical to the present invention. However, the at least one edge may be tapered, and the edges made smooth, so that the patch presents a surface to the skin of the user which is as smooth and frictionless as possible, thus preventing undesirable abrasion and friction from dislodging the patch adhered to the skin of the user.

In addition, all the patches are provided with an adhesive on the inner, skin-facing surface. The adhesive may be a coating sprayed on, or may be a distinct substrate layer with a tacky surface on both sides. To protect the inner layer of adhesive prior to the application of the patch, all the embodiments are provided with a releasable liner. "This protective liner is a film which is easily removed from the" inner surface of the patch "just prior to application on the skin. A release agent in the form of a thin coating is applied to paper, polymer coated paper, or polymer film, which provides structure to the liner. This release agent is necessary to prevent the" skin-facing adhesive "from sticking to its protective liner. Silicone and fluorocarbon-coated release liners are commonly used in transdermal systems for this reason" (Cleary). As a means of consistently describing the features of the present invention, the release liner will not be termed a layer in and of itself, since it is removed prior to application of the present invention.

All of the non-condom embodiments are constructed with at least one outer, stretchable, impermeable barrier layer composed of polyvinyl, polyethylene, polyester or aluminized polymer films and composite films, or any other suitable, impermeable, stretchable and flexible material. The at least one outer layer extends beyond the perimeter of the underlying layers, and has an adhesive material on the inner surface. The underlying layer or layers of the patch, depending on the embodiment, thus comprise and occupy a central area within the perimeter of and under the outer layer. The at least one outer layer serves as a seal, as further described in detail.

The inner surface of this at least one outer layer is coated with an impermeable adhesive which serves the dual function of anchoring the transdermal patch to the skin of the user and attaching underlying layers to the at least one outer barrier layer. To provide instant anchoring to the skin, the adhesive must adhere aggressively and instantaneously with only very slight pressure. The adhesive can be any well known sticky surgical-grade adhesive, or other pressure sensitive adhesive known to the art, and applied by conventional means. Examples are described in U.S. Pat. Nos. 4,638,790 and 4,475,910.

The patch is designed to contain the vasodilator so as to seal it in and prevent its leakage or escape from the area of intended male user skin contact. It is desirable to prevent any and all contact of the vasodilator with the inner tissues of the sex partner.

Accordingly, the patch, while permitting intended male user skin contact with the vasodilator, is designed with an impermeable outer layer, or barrier layer, to prevent vasodilator escape through the upper surface of the patch, and with an impermeable adhesive to prevent unwanted leakage at or from the at least one edge of the patch as well. Thus the patch provides means for sealing the vasodilator within the central portion of the patch away from the woman's vaginal tissues.

In the first embodiment, i.e., the first non-condom embodiment for use apart from and/or without a condom, the vasodilator is provided within a plurality of layered transdermal patch. Delivery of the vasodilator to the penis is accomplished through percutaneous absorption. In one example, such as a 3-layered embodiment, the three layers comprise at least one outer barrier layer, as described above, at least one middle layer containing the vasodilator, and at least one inner layer. The vasodilator is stored and contained in the at least one middle layer of the transdermal patch, which functions as a vasodilator reservoir conventionally in the manner of transdermal medication patches to deliver the vasodilator to the skin surface when the patch is adhered to the skin of the user.

The at least one middle layer contains the vasodilator in a suitable transdermal vehicle, which, as described in U.S. Pat. No. 5,124,158 to Ruwart et al., may be a liquid, a cream, a gel or a paste, all of which are generally known in the art for transdermal use. Typical transdermal compounds which may be used in the present invention, are polyethylene glycol, propylene glycol, triacetin, propyl carbonate, ethanol and isopropyl myristate. The aforementioned typical transdermal compounds may be contained in a reservoir or alternately can be applied to porous or other materials suitable for preparing a transdermal patch, as Ruwart, U.S. Pat. No. 5,124,158 has described.

The at least one inner layer of the multi-layered patch is typical of similar inner layers of some conventionally constructed layered patches. The at least one inner layer of a 3-layered first embodiment of the present invention comprises a means for dispensing the vasodilator through the skin of the male user, for example, such as a membrane made of plastic in the transdermal patch art, having microholes. The microholes in the membrane provide openings that limit the surface area of the middle, vasodilator-containing layer exposed to the skin of the user, thus regulating the amount of vasodilator available.

In this manner regulated dispensing of vasodilator is achieved, and dispensing may be selectively regulated by regulating the number, spacing and diameter of the microholes to achieve selectable total surface areas for conduction of vasodilator through the membrane for skin surface contact. Such at least one inner layer membrane materials are usually films made from non-woven, woven or foamed polymers, or from films made porous by various techniques, as described by Gary W. Cleary in Transdermal Drug Delivery, Cosmetics and Toiletries, Vol. 106, May 1991.

The inner, skin-facing surfaces of the at least one membrane inner layer is coated with a second, comparatively weaker adhesive, which anchors the at least one inner layer to the skin of the user. The aforementioned adhesive is weaker compared to the strong barrier layer adhesive, which secures the entire transdermal patch system to the skin of the user.

The comparatively weaker, membrane-anchoring adhesive is permeable to allow diffusion of the vasodilator through the comparatively weaker adhesive, so as to permit vasodilator to reach and make contact with the skin of the male user. If diffusion of the vasodilator through this comparatively weaker adhesive failed to occur, the vasodilator could not reach the skin of the user, since the vasodilator is contained in the at least one middle layer of the patch and as such is spaced apart from the skin of the user by the weaker adhesive, among other materials as herein described.

Such adhesives as the aforedescribed comparatively weaker adhesive are known to provide adhesion of the transdermal patch system to the skin, and yet are easily removed without removing any skin or leaving a residue.

Desirable characteristics for such a comparatively weaker adhesive material include the ability to adhere very aggressively to a backing material, e.g., the skin-facing inner surface of the aforedescribed microhole membrane while adhering to a lesser extent to skin. Pressure sensitive adhesives which provide a desirable, relatively weak skin adhesion are viscoelastic materials, which, in solvent-free form, remain permanently "tacky", and are described by Cleary in Transdermal Drug Delivery.

As described above, the construction of the multi-layered transdermal patch, such as a 3-layer patch, provides for the stretchable at least one outer layer to completely cover and seal the at least one middle and inner layers. Thus the vasodilator is contained within the patch and only the skin of the male user is permitted to come in contact with it. The transdermal patch system thus seals and prevents leakage of the vasodilator, and prevents inadvertent unwanted contact of the internal tissues of a female sex partner with the vasodilator. This covering and sealing function of the outer layer of the multi-layered patch, such as a 3-layer patch, is also provided by the at least one outer layers in a 2-layer embodiment of the present invention and a flexible solid embodiment, both of which will be described in detail.

In a second embodiment of the present invention, the vasodilator is provided within a two-layered transdermal patch. The two-layer form is similar to the three-layer form, except that, unlike the 3-layer patch, the 2-layered embodiment has no membrane with microholes to restrict the diffusion of medication to the skin.

Compared to the 3-layered patch, this second, 2-layered embodiment makes a larger amount of vasodilator available to the skin of the user more quickly, since there is no microhole membrane to restrict and regulate dispensing of the vasodilator to the skin.

The two-layer patch has an impermeable outer barrier layer in the same manner as the 3-layered embodiment. Also as with the 3-layered patch, the 2-layered second embodiment is provided with an impermeable adhesive material coated on the inner surface, which faces and adheres to the skin of the user, and a smaller at least one inner layer containing the vasodilator material. The impermeable adhesive coated upon the inner surface of the at least one outer layer serves the dual function of securing the at least one inner layer with vasodilator to the outer layer and also fastening the at least one outer layer to the skin. The at least one inner layer, covered by the at least one outer layer when the patch is in use, is thus secured to the skin by means of the at least one outer barrier layer being adhered to the skin of the user and serving as a broad bandage providing adhesion, anchoring, covering and sealing.

The vasodilator, carried within a suitable transdermal vehicle, is stored and contained in the smaller, inner vasodilator-reservoir layer of the 2-layered transdermal patch. The inner surface of the drug-containing at least one inner layer is coated with a second, comparatively weaker adhesive which is comparatively more easily releasable, and which serves to attach the drug carrying at least one inner layer to the skin of the user. In a fashion analogous to the permeable weaker adhesive of the multi-layered embodiment, such as a 3-layer embodiment, this second adhesive is permeable to permit transmission of the vasodilator from the reservoir layer through the permeable adhesive and thence into direct contact with the skin of the male user. The difference between the 2-layered and 3-layered embodiments is that on the 3-layered embodiment, as above described, the weaker, more releasable adhesive is coated upon the at least one inner surface of the inner layer, which comprises a membrane having microholes. In the 2-layered embodiment, the analogous weaker adhesive is coated upon the vasodilator-containing patch layer itself, since there is no membrane having microholes in the 2-layered embodiment.

In a variant of this 2-layered embodiment, the at least one inner surface of the drug-containing inner layer is not coated with a permeable adhesive, so that the vasodilator drug layer itself directly contacts the skin of the user. As in other embodiments of the present invention, the vasodilator is confined under the at least one outer, barrier layer, which acts as a seal and prevents vasodilator material from escaping the confines of the transdermal patch. The impermeable stronger adhesive anchoring the at least one outer barrier layer to the skin of the user further serves to seal the vasodilator and thus prevents vasodilator leakage laterally from around the sides and the at least one edge of the patch.

The 2-layer patch functions conventionally in the manner of transdermal medication patches to deliver the vasodilator to the skin surface when the patch is adhered to the skin of the user. As in the 3-layered embodiment, the patch itself is suitably thin and flexible, so as to be able to bend and conform comfortably with the movement of the surface of the skin, and the at least one edge of the multiple layers may be tapered so that the patch presents a surface to the skin of the user which is as smooth and frictionless as possible, thus preventing undesirable abrasion and friction from dislodging the patch adhered to the skin of the user.

In the third embodiment, the vasodilator is provided in the form of a flexible solid patch. As in the 2-layered embodiment, the flexible solid patch is constructed of an outer, impermeable barrier layer, and at least one inner layer containing the vasodilator material. As in the first 3-layered and second 2-layered embodiments, the at least one outer layer extends beyond the perimeter of the at least one inner layer.

However, the third, flexible-solid embodiment contains an additional adhesive. The adhesive described in the first and second embodiments is also used in the third embodiment. For purposes of describing the third embodiment, the adhesive used in the first and second embodiments, and also used in the third embodiment will be termed the first adhesive to distinguish it from the second adhesive which comprises a component of the flexible solid material described here in further detail. The first adhesive, described in detail above, is relatively stronger in adhesive strength than the second adhesive, described in further detail below.

In the third embodiment, unlike the first and second embodiments, the vasodilator material is mixed with a comparatively weak adhesive, and the vasodilator-weak adhesive mixture is spread in a thin, slightly moist layer in the center of the inner surface of the impermeable, at least one outer barrier layer. The vasodilator-weak adhesive mixture comprises a material which has a rubbery texture and is a flexible solid. The adhesive component of the flexible solid may be the same as described in the wart remover transdermal patch known by the trade name TRANS-VER-SAL.RTM. in which the flexible solid material is comprised of polyethylene glycol-300 USP, Karaya, propylene glycol USP, and quaternium 15. In the TRANS-VER-SAL.RTM. patch the aforedescribed flexible adhesive material is mixed with about 15% salicylic acid for application to the skin for wart removal.

In the third embodiment, as with the first and second embodiments, the at least one outer layer is provided with a coating of a relatively stronger adhesive on its inner surface, as described in detail in the first and second embodiments of the present invention. The stronger adhesive serves the dual function of holding the vasodilator-mild second adhesive mixture to the inner surface of the patch and fastening the patch to the skin.

As with the first and second embodiments, the third embodiment patch itself and the vasodilator material are suitably thin and flexible, so as to be able to bend and conform comfortably with the movement of the surface of the skin. The patch functions conventionally in the manner of transdermal medication patches to deliver the vasodilator to the skin surface when the patch is adhered to the skin of the user.

The vasodilator-mild adhesive mixture comprises the flexible solid material of this third, flexible solid embodiment of the present invention. The mild adhesive of the flexible solid-vasodilator mixture allows the vasodilator to be released for percutaneous absorption through the skin of the male user. The flexible solid comprising the vasodilator and mild adhesive mixture is secured in contact with the skin of the user when this flexible solid embodiment is in use.

Of the embodiments discussed above, the three-layer embodiment provides the greatest control over the rate of dispensing of the vasodilator to the skin of the user. Vasodilator dispensing can be controlled by controlling the permeability of the relatively more releasable milder adhesive coated on the microhole membrane inner surface, by controlling the thickness of the microhole membrane inner layer, and by varying the size, number and spacing of the microholes. Of the multi-layered embodiments, the 3-layer embodiment is the preferred embodiment.

Selective variation and control of the effectiveness of the patch itself may also be achieved by varying the absolute dose of the vasodilator contained in the patch of the present invention and also, separately, by selectively varying the nature of the vasodilator. As pointed out, it is known that individual vasodilator materials such as papaverine produce penile erections, and it is also known to synergistically combine vasodilators such as papaverine, phentolamine and prostaglandin to produce erection.

It is anticipated that the patch of the present invention will be provided in a variety of dosages, comprising a spectrum from small dose to large dose, with said doses to be determined by a treating physician and/or an individual male user. It is anticipated that vasodilator drug choice and dosage for the present invention, as for all medications, will be determined by the usual and well known variety of individual medical considerations in the case of each user.

The present invention is thus provided in a variety of vasodilator drugs, and drug combinations, and also in a variety of dosage strengths, so as to meet the medical requirements of the widest possible spectrum of male users.

In cases when the rate of diffusion needs to be maximized, for example, where fastest possible delivery of vasodilator to user skin is desired, the second embodiment, with an absence of a microhole membrane, is a preferable alternative. This second embodiment may be utilized without an adhesive on the inner surface of the inner layer, thus placing no adhesive and no membrane between the skin of the user and the vasodilator reservoir. Such a no-inner-adhesive variant of the second embodiment produces the fastest vasodilator delivery to the skin among all of the embodiments of the present invention.

All three above described embodiments can be used by affixing to various parts of the users body in the genital area, for instance either at the base of the penis, or behind the scrotum.

The patch of the present invention is manufactured with a conventional release liner material for protecting the adhesive. The release liner is removed by the user just before applying the patch to the skin. The user peels off the release liner from the adhesive of the present invention in the manner of release liner removal from well-known strip bandages. As with strip bandages, light manual pressure will serve to cause adherence of the aforedescribed adhesives to the skin of the user.

When used at the base of the penis, the patch may be manufactured as a strip with rounded ends, placed circumferentially at the base of the penis substantially as an annular ring, or may be any other convenient shape. The patch may be manufactured as a plurality of small round or oval disks, and, if so, preferably as a pair of such disks. These disks are preferably placed at the base of the penis, one on each side, for example, where the plurality is comprised of a pair of such disks.

The material and/or materials of the patch in all three embodiments may be made stretchable to accommodate the distention of the skin adjacent to the at least one inner layer during erection. Alternately, substrate of the at least one inner layer or layers may be made stretchable to accommodate the distention of the skin adjacent to the at least one inner layer during erection. The at least one outer layer may be manufactured of a stretchable plastic or latex.

The patch or plurality of patches would be placed at the sides of the flaccid penis, near the base. As erection is achieved, the stretchable at least one outer layer expands to accommodate the increased circumference and length of the penis, without causing undue constriction or discomfort, and at the same time the at least one outer layer would continue to adhere firmly to the skin of the user.

In addition, the patch has at least one edge, since it is wafer-like in contour, and may be manufactured as a disk, a square, or any useful shape for a medicinal patch. The patch may be provided with a taper in its thickness, so that while its thickness is not great, the thickness is nonetheless tapered toward the at least one edge. The at least one edge is further made smooth. The tapering and smoothness of the at least one edge ensures a substantial absence of friction and mechanical obstruction when the patch moves relative to an adjacent surface.

When used behind the scrotum, the patch may be manufactured as an oval, rounded triangle, or any useful shape for a medicinal patch. Hair in this scrotum area may need to be removed to allow effective contact between the patch and the skin of the user.

In addition to the foregoing discussion of transdermal patch-delivered vasodilator material for producing a penile erection, the present invention also combines a conventional condom-with a transdermal patch-delivered vasodilator pharmaceutical material for generating and maintaining the erection of the penis for sexual intercourse. Delivery of the vasodilator to the penis is accomplished essentially through percutaneous absorption. In the condom-embodiments of the present invention, it is necessary to place the transdermal patch near or substantially at the tip of the condom, where the condom tip may also be identified as the reservoir end, the sealed end, or the distal end for reference. Thus, in the condom-embodiments of the present invention, the transdermal patch will be applied to the penis at, on or near the glans thereof, depending upon user application of the condom-transdermal patch combination.

When used by uncircumcised males, the patch may have to be located behind the foreskin of the user. Nonetheless, in the case of uncircumcised males, the in-condom patch will be disposed within the condom so as to result in placement at, substantially at, or near the glans of the users penis.

The present invention may be manufactured with a suitable marker on the outside of the condom to visually indicate the location of the patch. If concealment so as not to embarrass the male user is desired, the visual marker of patch location in the condom may be absent or dimly distinguished, so that the user may know its location without unduly calling attention visually to the fact that the condom has anything inside of it. Use of a visual marker is not critical to the present invention since the user will have to remove the releasable liner when applying the condom, so he will know where the patch is. In addition, the user will probably be able to feel the patch, even though the patch is stretchable. Also, unless the condom is totally opaque, the patch will be somewhat visible through the condom.

The patches used in all of the condom-embodiments can have any tabular shape, such as a square, oblong or oval, or any other suitable shape. A preferable alternative to a disk, square or other shape of patch in any of the condom-embodiments is to construct the transdermal patch as an annular ring disposed within the condom, preferably disposed so as to be at, substantially at, or near the glans of the user's penis when the patch is in use. The shape of the patch is not critical to the present invention.

The material and/or materials of the patch in all the condom-embodiments may be made stretchable to accommodate the distention of the skin adjacent to the patch during erection.

The first three condom-embodiments of the present invention are similar to the three non-condom embodiments discussed above. Each of the above described non-condom embodiments is provided within a conventional condom. There are differences in the adhesive systems between the condom and non-condom embodiments, and these differences will be described in detail.

In the first condom-embodiment of the present invention, the vasodilator is provided within a three-layered transdermal patch which is similar to the first non-condom embodiment described above, except that the at least one outer surface of the barrier layer is provided with an adhesive which attaches the 3-layer patch to the inner wall of the condom.

The second condom-embodiment of the present invention is similar to the two-layered transdermal patch of the second non-condom embodiment described above, except that the at least one outer surface of the barrier layer is provided with an adhesive which attaches the 2-layer patch to the inner wall of the condom.

In the third condom-embodiment, like the third non-condom embodiment, the vasodilator is provided within a flexible solid transdermal patch, except that the outer surface of the at least one barrier layer is provided with an adhesive which attaches the flexible solid patch to the inner wall of the condom.

As in the case of the non-condom embodiments, a 3-layered condom-embodiment is preferred because it gives the greatest control over the rate of dispensing of the medication, but, in cases where the rate of dispensing needs to be maximized, the second, 2-layered embodiment, without adhesive on the inner surface of the inner layer, is a preferable alternative.

Each of the condom-embodiments described above can be constructed in two variations, each employing a different strength of the adhesive used to attach the patch to the inner wall of the condom.

In the first variation, there is an adhesive system employing adhesives of different strengths for selective release. The adhesive securing the transdermal patch to the condom wall is made releasable, and thus weaker, whereas the adhesive securing the patch to the penis skin is made stronger. When used, the condom wall adhesive releases, while the penis skin adhesive remains secured to the skin of the users penis. The transdermal patch is thereby transferred from the condom wall to adhesive contact with the skin of the user's penis when the patch is put into use.

This selective adhesive system herein described can be user controlled or can function automatically. Where user control is desired, the stronger penis skin adhesive upon the inner surface of the transdermal patch is made pressure sensitive. The user applies manual pressure upon the outside wall of the condom adjacent to the position of the transdermal patch which is inside the condom. The user will know the location of the patch because a suitable visual indicator is provided on the outside wall of the condom adjacent to the location of the patch.

When the stronger adhesive of the inner, skin-facing surface adheres to the skin, the weaker, releasable adhesive securing the patch to the condom wall will thereupon release, allowing the patch to remain on the penis and to move relative to the inside wall of the condom along with the penis.

As with the non-condom embodiments of the present invention, the construction of the patches in these various condom-embodiments is designed to prevent the vasodilator material from contacting the skin of the female during use. Even though the transdermal patch can detach from the inner wall of the condom, each patch is constructed with an impermeable barrier layer which comprises the at least one outer layer of each respective condom embodiment, and the adhesive that anchors the patch to the skin of the penis is designed to remain adhered to the skin of the penis, preventing any lateral leakage of the vasodilator.

In another variation of the various condom-embodiments, the adhesive anchoring the patch to the condom wall is not made releasable. The patch remains attached to the condom wall during use, and the adhesive which attaches the patch to the penis is not made stronger than the adhesive attaching the patch to the condom wall, so that the patch remains attached to both the inner condom wall and the skin during use, and removal of the condom from the penis will result in removal of the patch from penis skin contact as well. Where the use of a condom is favored, this is the preferred design of this embodiment.

In all the various condom-embodiments, the surfaces which will be adjacent to the patch, of course, are (a) the condom wall; and (b) the skin of the penis. In the first variation, the transdermal patch is transferred from the condom wall to the skin of the user's penis by the system of differential adhesives described above. Therefore, in the first variation, the surface adjacent to the patch, relative to which the patch must move, is the inner wall of the condom. The above described thickness taper and smoothness of the at least one edge prevent mechanical tearing of the condom wall due to the relative motion of the patch and the condom wall. In the second variation, the patch remains attached to both of the adjacent surfaces.

The further condom-embodiments of the present invention are similar to each other in that the transdermal patch has no at least one outer, impermeable barrier layer. The wall of the condom itself serves as the barrier, preventing leakage of the vasodilator. As a result, in both the further condom-embodiments, the patch must remain anchored to the inner wall of the condom, so that removal of the condom will result in removal of the patch containing vasodilator as well.

As in all the embodiments heretofore described, the patch may be provided with a taper in its thickness, so that while its thickness is not great, the thickness is nonetheless tapered toward the at least one edge. The at least one edge is further made smooth. The tapering and smoothness of the at least one edge ensures a substantial absence of friction or chafing when the patch is in use.

As with the previously described embodiments, in the further condom-embodiments the patch itself and the vasodilator material are suitably thin and flexible, so as to be able to bend and conform comfortably with the movement of the surface of the skin.

In a further condom-embodiment of the present invention, the vasodilator is provided within a two layered transdermal patch. The at least one outer, condom-facing layer contains the vasodilator in a suitable transdermal vehicle, contained in a reservoir or alternately applied to porous or other materials suitable for preparing a transdermal patch, as previously described. The outer surface of the at least one outer layer is provided with a strong adhesive, which anchors the patch to the inner surface of the condom. The at least one inner, skin-facing layer is a plastic membrane with microholes as previously set forth. The at least one inner layer is held in contact with the skin of the user by a suitable adhesive in accordance with the foregoing discussion and the microholes permit regulated dispensing of the vasodilator from the at least one outer reservoir layer of the patch to the skin of the user.

The two surfaces of the at least one inner membrane layer are coated with a comparatively weak adhesive as follows: the inner surface of the at least one inner membrane layer is anchored to the skin of the user. The outer surface of the at least one inner membrane layer is also adhered to the outer reservoir layer. The aforedescribed weak adhesive is permeable, to allow dispensing of the vasodilator to the skin by diffusion through and across the weak permeable adhesive, as heretofore described.

The second further condom-embodiment of the present invention is analogous to the earlier described flexible solid embodiments. The vasodilator material is mixed with a mild adhesive, and the vasodilator-mild adhesive mixture is spread in a thin, slightly moist layer on the inner surface of the condom. The vasodilator-mild adhesive mixture comprises a material which is a flexible solid, as described in detail above. In the second further condom-embodiment, the inner surface of the condom which will contact the flexible solid is provided with a coating of a stronger adhesive on its inner surface. The stronger adhesive serves the function of adhesively holding the at least one flexible solid layer to the inner surface of the condom, so that removal of the condom will result in removal of the at least one flexible solid layer as well.

The patch functions conventionally in the manner of transdermal medication patches to deliver the vasodilator to the skin surface when the patch is adhered to the skin of the user.

Any of the aforementioned various condom-embodiments may be provided with a suitable lubricant and/or spermacide, such as Nonoxynol-9, or any other suitable lubricant/spermacide. The lubricant/spermacide would coat the entire inner and outer surfaces of the condom. The lubricant/spermacide can be isolated from the vasodilator material and from the adhesive material on the inner, skin-facing surface of the patch by the releasing liner.

The preferred embodiment is a method for treating male impotence by inducing a male penile erection on demand immediately before sexual intercourse, including the steps of applying directly to the skin of a male user in the penile region thereof, such as for example, to the scrotum, immediately prior to sexual intercourse a transdermal patch having adhesive application means for adhering the same to the male user's skin.

The transdermal patch has therein an effective amount of treatment composition such as a vasodilator.

For example, in one embodiment of the present invention, 10 milligrams of phentolamine mesylate is dissolved in 0.230 milliliters of alcohol (ref. The Merck Index, Twelfth Edition, 1996, page 1252. An alcohol solution is preferred since aqueous solutions cannot be stored for any length of time. The dosage for an adult of phentolamine mesylate is 5 milligrams (Physicians Desk Reference,52^nd Edition, 1998, pp 1893-1894). It is assumed that there will be a 50 percent transdermal transfer of the active ingredient across the thin scrotal skin of the penis. The thickness of the textile carrier in the patch is 0.160 inches, and the textile material in the patch is one inch square. The total volume of the solution of 0.10 milligrams of phentolamine mesylate and 0.230 milliliters of alcohol is 0.240 milliliters. Conversion of metric units to units of measurement gives a solution thickness of 0.37 milliliters, or 0.146 inches. The textile carrier contains 91 percent by volume of the solution and 9 percent by volume of the textile material.

Other vasodilators may also be employed, such as papaverine or prostaglandin E-1, or mixture thereof.

The transdermal patch has a dispensing means for dispensing the vasodilator only to the skin of the user in an effective amount sufficient to induce a male penile erection on demand immediately prior to sexual intercourse and a barrier means for preventing contact of the vasodilator material with the internal genital tissues of the male user's sexual partner.

The transdermal patch may include a plurality of layers with an inner layer for contacting the skin of the male user in the penile region including a reservoir for the vasodilator material and the dispensing means therefore, and an outer barrier layer which completely envelopes the inner layer and the reservoirs and extends beyond all the peripheral edges of the inner layer.

Alternatively, the treatment composition includes a vasodilator selected from the group consisting essentially of papaverine, phentolamine and prostaglandin E-1.

The method of producing a male penile erection on demand immediately before sexual intercourse and for reducing friction during sexual intercourse includes the steps of:

a) applying the transdermal patch on demand immediately before sexual intercourse with an adhesive application means for adhering the patch to a male user's skin in the penile region, wherein the transdermal patch includes an inner dispensing layer having the treatment composition comprising the vasodilator;

b) dispensing the vasodilator material only to the skin of a user in the penile region by applying the transdermal patch to the penile region of the user.

The patch further has a barrier means for preventing contact of the vasodilator material with the internal genital tissues of the male user's sexual partner. For example, the patch has a plurality of layers, including an outer layer opposite to the inner dispensing layer. The transdermal patch further has an outside perimeter edge extending around a perimeter of the outer layer and the inner dispensing layer.

The patch includes a means for producing reduced friction and reduced mechanical interference when the patch undergoes movement relative to an adjacent surface of the internal genital tissues of the user's sexual partner with which the patch is in slidable contact during sexual intercourse, such as a smooth, continuous taper of thickness wherein the thickness of the patch is greatest toward a center of the patch and thinnest at the outside perimeter edge.

The patch further may have a middle layer therebetween. Each respective aforementioned layer has an outer surface facing away from the penile region skin of the user and an inner surface facing toward the penile region skin of the user.

The method steps may also further include:

a. providing the outer surface of the outer layer to provide an impermeable barrier layer for sealing the vasodilator within the confines of the patch;

b. providing a middle layer with a reservoir containing the vasodilator;

c. dispensing the vasodilator from the inner layer of the patch through the penile region skin of the male user.

The outer layer has substantially a larger surface area than a surface area of the middle layer and a surface area of the inner layer. The outer layer extends radially beyond the respective exterior edges of the middle and inner layers for sealing the vasodilator within the patch and for sealing the vasodilator in contact with the penile region skin of the user of the patch.

The radial extension of the outer layer extends beyond the dimensions of the middle and inner layers and functions as a peripheral area. The outer layer further has a central area having an outer surface and an inner surface, the middle layer being adhesively attachable to the inner surface of the central area.

The inner surface of the outer layer is coated with a pharmaceutically suitable impermeable adhesive covering the peripheral area of the outer layer as well as the central area thereof, for, respectively, adhering sealably to the penile region skin of the user and adhering to the middle layer of the patch.

The outer surface of the inner layer is adherable to the middle layer by means of a thin coat of a suitable adhesive which the adhesive is permeable to the vasodilator. The inner surface of the inner layer is provided with a coat of an adhesive permeable to the vasodilator, and the adhesives exposed to the penile region skin of the user are provided with a removable protective release liner to be removed before the patch is adhered to the penile region skin of the user.

While the patch is preferably planer, such as circular or square, it may also be an annular sleeve ring.

In addition, the means for dispensing the vasodilator through the penile region skin of the male user may be a plastic film having microholes.

Claim 1 of 17 Claims

1. A method for treating male impotence by inducing a male penile erection on demand immediately before sexual intercourse comprising the steps of applying directly to the skin of a male user in the penile region thereof immediately prior to sexual intercourse a transdermal patch having adhesive application means for adhering the same to the male user's skin, said transdermal patch having an effective amount of treatment composition comprising a mixture of vasodilators, said transdermal patch having a dispensing means for dispensing said vasodilators only to the skin of the user in an effective amount sufficient to induce a male penile erection on demand immediately prior to sexual intercourse and barrier means for preventing contact of said vasodilator material with the internal genital tissues of the male user's sexual partner;

wherein further said vasodilator mixture comprises a mixture of papaverine, phentolamine and prostaglandin E-1.

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