WO 2013/029160 A2 7 March 2013 (07.03.2013) P O P C T

Home , Finger

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2013/029160 A2 7 March 2013 (07.03.2013) P O P C T

(51) International Patent Classification: Not classified DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (21) International Application Number: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, PCT/CA20 12/000806 ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (22) International Filing Date: NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, 30 August 2012 (30.08.2012) SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (25) Filing Language: English ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 61/529,460 31 August 201 1 (3 1.08.201 1) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, (72) Inventor; and TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (71) Applicant : VALA, Philip [CA/CA]; 1237 Wood Place, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, Oakville, Ontario L6L 2R4 (CA). MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, (74) Agent: GOWAN, Gerald A.; Gowan Intellectual Property, ML, MR, NE, SN, TD, TG). 627 Lyons Lane, Suite 204, Oakville, Ontario L6J 5Z7 (CA). Published: (81) Designated States (unless otherwise indicated, for every — without international search report and to be republished kind of national protection available): AE, AG, AL, AM, upon receipt of that report (Rule 48.2(g)) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM,

(54) Title: CUTANEOUS PATCH FOR CLEANSING OR FOR TACTILE OR ERECTOGENIC STIMULATION

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© (57) Abstract: A patch for cutaneous application to the external surface of an elongated member of a human body for purposes of cleansing or for tactile stimulation and/or delivery of a transdermal pharmaceutical agent during sexual activity, has an underside o having at least a portion thereof coated with a human skin compatible adhesive, for application to the skin of an elongated member of a human body. The patch has a dimension of length which is greater than its dimension of width, and has an outer surface which is distal from the skin when applied to a finger of a human hand or to a human male penis. The outer surface of the patch may be a o textured surface or a smooth surface. At least one transdermal agent may be applied to the underside of the patch, and is typically an erectogenic agent. CUTANEOUS PATCH FOR CLEANSING OR FOR TACTILE OR ERECTOGENIC STIMULATION

Field of the Invention This invention relates to a cutaneous patch for cleansing, or for tactile and/or erectogenic stimulation during sexual activity, and more particularly the present invention relates to a patch which may be applied to an elongated member of the human body such as a finger of a human hand or a human male penis. In a preferred embodiment, the cutaneous patch is most typically designed to be attached to such an elongated member of the human body using a human skin compatible adhesive, and may be employed by males or females during such sexual activity. As such, the device is particularly intended for use by a human male during such activities and sexual intercourse. The cutaneous patch may provide tactile stimulation by having a textured outer surface, or it may provide erectogenic and other pleasurable feelings as a consequence of an appropriate transdermal agent at the underside of the patch, or it may provide both functions. The use of the word "erectogenic" as used throughout the following disclosure is meant to convey the meaning of inducing or enhancing an erection in a human male penis, during sexual activity.

Background of the Invention The present invention is intended not only as a novelty device, but it is particularly intended for use as an aid to sexual fulfillment by the user and/or the user's sexual partner. What is provided, therefore, is an adhesive skin patch which is shaped and textured so as to provide enhanced tactile stimulation; and in most embodiments also to provide such other human sexual phenomena as may be obtained through the use of transdermal chemical agents. The device might also be used in cleansing applications, and include, for example, a microdermabrasion or exfoliation surface as the textured surface.

It is well recognized not only by psychiatrists, psychologists, and others, as well as by the ordinary man or woman in the street, that a basic human need is for physical contact of a sexual nature. Such physical contact usually will occur between loving partners, who may engage in foreplay, and sexual intercourse. Typically, this foreplay or intercourse involves or is preceded by sexual stimulation of the partners. Such stimulation may be enhanced through the medium of a textured surface being rubbed against the sexual organ, or sensitive areas of the body. Of course, the ultimate human sexual experience is that of sexual intercourse, but often such experience may be less than satisfactory due to several causes, or the experience might otherwise be enhanced by use of artificial means. The present invention seeks to enhance this experience. Moreover, the present invention recognizes the requirement that the use of any ancillary device of any sort must be as unobtrusive as possible, so as not to interfere with any sexual activity which is being undertaken. Still further, there is a specific requirement that any ancillary device must be capable of being easily applied to dry, clean skin; and also, depending on the circumstances, that it must be capable of being applied to a flaccid, semi-erect, or erect human male penis, and to accommodate changes in girth and length of the human male penis due to swelling and engorgement. Of course, it goes without saying that any ancillary device in keeping with the present invention must be provided to the market at the lowest possible price, and for reasons of hygiene it will typically be disposable after a single use. However, such single use may be relatively prolonged, so that the ancillary device of the present invention must be capable of withstanding

exposure to water, lubricants, soap, bodily fluids, and so on; and must not be in danger of becoming dislodged or of falling off during sexual activity. The use of condoms during sexual intercourse is well known, and it is well known that the use of condoms is typically for the prevention of disease and/or the prevention of unintended impregnation. However, there are many circumstances where the partners will dispense with the use of a condom; and as such, the utilization of an ancillary cutaneous patch of the present

invention for its purposes is equally effective in the presence of a condom or in the absence of a condom.

Thus, a principal purpose of the present invention is to provide an ancillary cutaneous patch which may be employed during sexual activity to enhance the sexual experience, and yet be as unobtrusive as possible so as not to detract from the pleasure of such sexual activity. A huge variety of devices to enhance sexual pleasure and/or to fulfill the purposes of a condom, and/or to ameliorate the condition known as erectile dysfunction, have been employed over many years. Typical devices are described hereafter. Also, the use of transdermal patches has been known for many years, particularly for purposes of providing medications of various sorts to the patient. Such purposes have, of course, included the provision of morphine or other medications to alleviate pain, the provision of anti-nicotine medications so as to enhance

cessation of smoking by the user, and in some cases the provision of an erectogenic agent to the human male penis. Description of the Prior Art A number of patents are known which provide such devices, and to suit such purposes as are described above. For example, United States Patents 4,920,989 and 4,597,961 provide teachings for representative nicotine patches. A United States Patent which teaches an adhesively applied strip to provide fragrance and/or transdermal medication to the nose is 6,244,265

Typical textured condoms are taught in the following United States Patents: D 252,949; D 448,471 ; 6,308,708; 6,651 ,667; 6,672,309; and 6,983,751 . United States Patent 7,61 ,456 teaches a male sexual aid which is, in effect, a splint whose purpose is to support a human male penis and thereby provide additional rigidity thereto. A well known method for effecting or enhancing erection of the human male penis is to apply a prosthesis or so-called constrictor to the base of the penis so as to trap blood along the shaft of an engorged penis and thereby enhance its erectile rigidity. For example, United States Patent 5,370,601 teaches a penile erection prosthesis which is progressively inflatable so as to function effectively as a tourniquet or constrictor. Another patent, 5,695,444, teaches an elastic

ring which typically is arranged to encircle the human male penis and scrotum. Another penile

constrictor is taught in United States Patent 6,277,063, which provides a vacuum erection system and then means to transfer a penile constrictor onto the erect penis. Still another penile constrictor is taught in United States Patent 7,604,588, which provides for the use of the self-adhering elastic bandage which is coiled around the base of the penis. A condom is then applied to the engorged penis to protect the self-adhering elastic bandage from moisture and mechanical stress. Several United States Patents teach the use of the transdermal drug delivery device for the purposes of treating erectile dysfunction or so as to enhance erectile function. They include 4,867,982, which teaches a device for transdermal delivery of a medication by providing a matrix containing the drug, where the matrix is tacky but does not adhesively bond to the skin. The device is flexible and deformable so that it may be applied to sensitive areas of the human body

including the scrotum, labia, breast, or penis. Another such patent is 5 ,741 ,51 1, which provides for transdermal drug delivery to treat erectile dysfunction, and which comprises a patch containing a pharmaceutically active ingredient which is applied directly to the male glans penis. The patch may take the form of a cylinder, or it may be a multi-reservoir type patch. United States Patent 6,007,836 teaches a transdermal vasodilator whose purpose is to

maintain the erection of a male penis during intercourse. The vasodilator is contained in a transdermal patch which comprises a thin layered structure having smooth edges, which is applied to the skin of the penis of the user, and which is sealed against unwanted contraindicated leakage and contact with the internal tissues of a sex partner. Finally, United States Patent 7,61 7,827 teaches a container which may be applied to a condom which is placed over the penis of the user, and is arranged so that an internal frangible membrane is fractured upon insertion of the penis into the condom.

Summary of the Invention In accordance with one aspect of the present invention, there is provided a patch for cutaneous application to the external surface of an elongated member of a human body for purposes of cleansing, or for tactile stimulation or for delivery of transdermal agents, including pharmaceutical agents; - preferably during sexual activity. The patch has an underside having at least a portion thereof coated with a human skin compatible adhesive, for application to the skin of an elongated member of a human body, and preferably has a dimension of length which is greater than its dimension of width. The patch has an outer surface which is distal from the skin when applied to an elongated member of a human body. The outer surface of the patch is chosen from the group consisting of a textured surface and a smooth surface. The elongated member of a human body to which the patch may be applied is typically chosen from the group consisting of a finger of a human hand and a human male penis, although other body locals might also be used. For example, the patch may be square or circular, and applied to a person's hand, or the like. The present invention also provides a method for the production of the patches of the

present invention. As such, in a further aspect, the present invention also provides a method for the production of a patch for cutaneous application to the external surface of a human body for the purposes of cleansing or for tactile stimulation or for delivery of transdermal agents during sexual activity, wherein said patch is first prepared as a product sheet by a process comprising: a) applying a plastisol to an upper layer of a woven or non-woven film and curing said plastisol to provide a pattern on the upper surface of the woven or non-woven film; b) utilizing an adhesive to attach a lower surface of said upper layer, to an upper surface of a flexible, water proof polyurethane film; c) providing a further layer of adhesive to the lower surface of said polyurethane film; and d) providing a paper and/or silicon coated release liner to said further layer of adhesive, so a to provide a protective, peel-off layer, and thus producing said product sheet; and cutting said product sheet into individual patches, having a desired shape and size. Detailed Description of the Invention In general, the cutaneous patch of the present invention further comprises a removable release film initially placed over at least said human skin compatible adhesive for removal therefrom prior to application of said patch to an elongated member of a human body.

When the patch is intended only for application to a finger of a human hand, or the like, the outer surface has a textured surface chosen from the group consisting of a plurality of outwardly extending bumps, studs, ridges, hair-like projections, relief patterns, crimps, cut-outs, an exfoliation surface, a microdermabrasion surface, or the like, and any combination thereof. Moreover, when the patch is intended for application to a human male penis, the outer surface may be smooth, or more preferably, it may have a textured surface chosen from the group consisting of a plurality of outwardly extending bumps, studs, ridges, hair-like projections, relief patterns, crimps, cut-outs, or the like, or any combination thereof. The patch may also be applied to sexual aids, or so-called "toys", and can be provided with a suitable outer surface for such applications.

Typically the materials for use in the production of the patch of the present invention are chosen from the group consisting of latex, silicone, natural rubber, PVC, plastisol, and plastisol additives including soft-hand extenders or puff additives, polyurethane or other plastic materials such as polyethylene, polypropylene, or the like, cellulosic materials including fibrous cellulosic derived materials, such as rayon or the like, and combinations thereof and therebetween. However, various other materials which are compatible for use with the human body, are not excluded. In its general use, the patch may comprise at least one transdermal agent applied to the underside thereof, wherein the at least one transdermal agent is chosen from the group consisting of an erectogenic agent, an agent to induce a warming feeling to the skin of the penis, an agent to induce a cooling feeling to the skin of the penis, or an agent to induce a tingling feeling to the skin of the penis, or pharmaceutical agents such as a local anaesthetic agent to induce delayed ejaculation, and combinations thereof.

The transdermal agent may be contained in the human skin compatible adhesive.

Alternatively, the transdermal agent may be contained in the human skin compatible adhesive in the form of microcapsules having the transdermal agent incorporated therein.

In some embodiments of the patch of the present invention, the transdermal agent may be applied to at least a portion of the underside of the patch as a separate layer.

In some embodiments of the patch of the present invention, a pair of additional edge layers is applied to the underside of the patch, and the human compatible adhesive, such as a suitable medical grade, acrylate adhesive designed for medical or surgical applications, or the like, is applied to the underside of the additional edge layers. Also, the transdermal agent is preferably contained in the void which is created between the pair of additional edge layers. In general, the external periphery of the patch is tapered downwardly from the outer surface to the underside. In certain embodiments of the patch of the present invention, the dimensions of the patch, including its thickness, are preferably sufficient so as to add girth, such as up to 0 .1 to 2.5 cm, but more preferably, 0.2 to 1.5 cm, or more, to an erect human penis when wrapped around the base of the penis.

In other embodiments of the patch of the present invention, the patch further comprises a pair of outwardly extending wings near one end thereof, wherein the length of the wings together with the width of the patch are sufficient to fully or partially enwrap a flaccid or semi-erect human male penis so that when the penis achieves a fully erect status, the wings and the adjacent portion of the width of the patch function as a penile constrictor. Still further, the patch of the present invention may comprise an internal void therewithin, and an openable release means to permit fluid communication from the internal void to the outer surface of the patch, and is such that the openable release means is chosen from the group consisting of an adhesively applied release film, a valve which is openable by pulling, a valve which is openable by being squeezed, a frangible film which will break by applying pressure thereto, and a frangible film which will break by being scratched. In such embodiment, the void may be filled with a fluid gel-like substance chosen from the group consisting of a lubricant, a flavoured gel, a scented gel, a warming gel, a cooling gel, and the like, and combinations thereof. One of the features of the cutaneous patch of the present invention is that, in general, the material of the patch exhibits the characteristic of being stretchable in any or all of the dimensions of length, width, or thickness thereof, so as to accommodate swelling and engorgement of a human male penis to which it is applied. Finally, another feature of the patch of the present invention is that the human skin compatible adhesive retains its adhesiveness when in contact with any of the group consisting of water, soap, lubricants, bodily fluids, and combinations thereof.

Brief Description of the Drawings The novel features which are believed to be characteristic of the present invention, as to its structure, organization, use and method of operation, together with further objectives and advantages thereof, will be better understood from the following drawings in which a presently preferred embodiment of the invention will now be illustrated by way of example. It is expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. Embodiments of this invention will now be described by way of example in association with the accompanying drawings in which: Figure 1 is a perspective view of a first embodiment of the present invention having a plurality of bumps or projections formed on the outer surface thereof; Figure 2 is a perspective view of a second embodiment of the present invention, having a plurality of reliefs or relief patterns formed in the outer surface thereof; Figure 3 is a perspective view of a third embodiment of the present invention, having a plurality of ridges formed in the outer surface thereof; Figure 4 is a perspective view of a fourth embodiment of the present invention, having an internal pocket or void therein; Figure 5 is a perspective view of a fifth embodiment of the present invention, having a pair of wings at one end, extending outwardly from the sides thereof; Figure 6 is a plan view of the embodiment of Figure 5 ;

Figure 7 is a perspective view of a sixth embodiment of the present invention having an exfoliation or dermabrasion surface formed on the outer surface thereof;

Figure 8 is an enlarged, partial perspective view of a further embodiment of the present invention; and

Figure 9 is a series of drawing intended to show the manufacture of the embodiment shown in Figure 8 .

Detailed Description of the Drawings The novel features which are believed to be characteristic of the present invention, as to its structure, organization, use and method of operation, together with further objectives and advantages thereof, will be better understood from the following discussion. Some general points concerning the construction of a cutaneous patch in keeping with the present invention may be learned from Figure 1. There, a first embodiment of a cutaneous patch 11 which is intended for application to the external surface of an elongated member of the human body - in general, a finger of a human hand, or a human male penis - so as to provide cleansing in some applications, or to provide tactile stimulation during sexual activity, is shown. The patch 11 has an underside 12 , and at least a portion of that underside 12 is coated with a human skin compatible adhesive so that the patch may be applied to the skin of a human hand, or to the skin of a human male penis. The patch 1 also has an outer surface 4 which is distal from the skin of the hand or penis when the patch is applied thereto.

As will be discussed hereafter, the outer surface 12 of any patch in keeping with the present invention may be a textured surface, or it may be a smooth surface. In the embodiment shown in Figure 1, the outer surface 14 is textured; in this case having a plurality of bumps or knobs 16. It will be understood, of course, that the outer surface may also be configured with a textured surface including a plurality of studs, ridges (see Figure 3), hair-like projections, relief patterns, crimps, cut-outs(see Figure 2), an exfoliation surface (see Figure 7), a microdermabrasion surface, or any combination thereof.

In general, any cutaneous patch in keeping with the present invention will be provided with a removable release film 18 which is removed from the underside 12 of the patch prior to its application to a finger of a human hand, or to a human male penis. The removable release film 8 preserves the adhesiveness of the adhesive layer or coating; and as will be seen hereafter, where the underside of the patch or the structure of the patch is such that a transdermal agent is included therein, so as to preclude premature loss of the transdermal agent. Obviously, the outer surface 14 is distal from the skin when any patch in keeping with the present invention is applied to the skin. Also, needless to say, the adhesive which is applied to at least a portion of the underside of any patch in keeping with the present invention must be compatible with human skin. It will be understood that when the patch such as that which is illustrated in Figure 1 is intended for use and application to a finger of a human hand, then the general intention for use of that patch is for manual stimulation of the male or female. Thus, typically, there is no transdermal agent applied to such a patch. Moreover, when the patch is intended for application to a finger of a human hand, the material from which the patch is made is less critical than if the patch is intended to be applied to a human male penis. In the latter case, it is usual for the material of the patch to be chosen from the group which consists of latex, silicone, natural rubber, PVC, plastisol, and plastisol additives including soft-hand extenders or puff additives, polyurethane or other plastic materials such as polyethylene, polypropylene, or the like, cellulosic materials including fibrous cellulosic derived materials, such as rayon or the like, and combinations thereof and therebetween. Typically, materials that are incompatible with the human body, are not used in the practice of the present invention.

Moreover, it is typical that any patch in keeping with the present invention should be flexible so as to be conformable to a human finger, a human male penis, or other body part. Ideally, the material of the patch is also one which is non-absorbent. Still further, in keeping with the present invention, a patch should exhibit the characteristic that it is stretchable in any one of its dimensions of length, width, or thickness, particularly when applied to a human male penis, so as to accommodate swelling and engorgement thereof. So as to induce or enhance the phenomenon of erection of a human male penis, it is usual that many embodiments of the cutaneous patch shall comprise at least one transdermal agent which is applied to the underside of a patch. Usually, such transdermal agent is an erectogenic agent; but it may also be or comprise such other transdermal agents as one which will induce a warming feeling to the skin of the penis, an agent which will induce a cooling feeling to the skin of the penis, an agent which will induce a tingling feeling to the skin of the penis, or even a local anesthetic such as Benzocaine (TM) which will induce delayed ejaculation. Of course, combinations of any of those transdermal agents may be employed, as the demand and requirement therefor shall exist. One vehicle whereby the transdermal agent may be applied to a cutaneous patch in keeping with the present invention may be for the transdermal agent to be contained in the human skin compatible adhesive. Such an arrangement is well known to those skilled in the pharmaceutical arts. A variation of such an application may be to incorporate the transdermal agent into a plurality of microcapsules. On the other hand, many embodiments of the present invention may incorporate the transdermal agent by having it applied to at least a portion of the underside 12 of the respective cutaneous patch, as discussed hereafter. Turning briefly to Figure 2 , a second specific embodiment of a cutaneous patch in keeping with the present invention is shown at 2 1. Here, the upper surface 14 comprises a plurality of cut-outs 20. The cut-outs 20 may also be configured as relief patterns. It will be understood that the stimulating effect of the upper surface 14 of the patch 2 1 will be somewhat different than the stimulating effect of the upper surface 14 of the patch 11. It will also be seen and understood, particularly from Figures 1 and 2 , that the external periphery of any cutaneous patch in keeping with the present invention may be tapered downwardly from the outer surface 14 towards the underside 12 , as shown at 22. Such a configuration will substantially preclude the risk of inadvertent detachment or peeling off of the patch from the skin of a finger or human male penis. Moreover, it will be seen and understood that the dimension of length of a patch keeping with the present invention is greater than its dimension of width, which is greater than its dimension of thickness. Figure 3 shows a portion of a cutaneous patch in keeping with the present invention, it being understood that at least the length of the patch has been cut so as to illustrate a particular feature of the present invention; and that the edges along the length of the patch may also have been cut so as to eliminate the taper 22 which is otherwise illustrated in Figures 1 and 2 . Here, a plurality of ridges 40 are shown having been formed on the upper surface 14 of the patch 3 .

More particularly, the structure of the patch 3 1 is such that the material of the upper layer 24 of the patch 3 1 is separated from the material of a lower layer 26, which includes underside 12 , by a film 28. The purpose of the film 28 may be twofold: the first being to provide a moisture proof barrier between the outer surface 14 and the underside 12 ; and the second being to provide a surface 30 to which a transdermal agent may be applied in the slot or void 32 which is formed between the two distinct layers 26A and 26B which are applied along the edges of the patch. In such a way, the transdermal agent may be applied to at least a portion of the underside 12 of the patch 3 1, as a separate layer. However, so as to ensure adhesion of the patch 3 1 to the skin of the human male penis, it may also be necessary for at least a portion of the underside 12 to have a human skin compatible adhesive applied thereto.

Turning now to Figure 4 , another embodiment of a cutaneous patch in keeping with the present invention is shown. Once again, the view has been somewhat truncated, particularly so as to show the presence of an internal void 34 which is contained within the structure of the patch

4 1. Also seen in Figure 4 is an openable release means 36, which will be described in greater detail hereafter. In this case, it is intended that the internal void 34 shall be filled with a fluid gel-like substance which will be in fluid communication to the outer surface 14 of the patch 4 1 through the openable release means 36. In other words, the gel-like substance which is contained in the internal void 34 is not intended to be a transdermal agent. Rather, that gel-like substance is intended to enhance the sexual pleasures of the partners because it may be a lubricant, a flavored gel, a scented gel, or any combination thereof.

The nature of the openable release means 36 is such that it will become open so as to allow fluid communication from the internal void 34 to the outer surface 14; and as such, the openable release means 36 may be an adhesive release film which would be removed just prior to the sexual activity for which it is desired, or it may be a valve which is openable by pulling, a valve which is openable by being squeezed, a frangible film which will break by applying pressure thereto - either downwardly against the film or upwardly from the gel-like substance within the internal void 34 when pressure is applied to the outer surface 14 of the patch 4 1 - or a frangible film which will break by being scratched.

Figures 5 and 6 provide yet another embodiment of a cutaneous patch 5 1 in keeping with the present invention. Here, the structure of at least the central portion of the patch 5 1, widthwise, is not unlike the structure of the patch 3 1 shown in Figure 3 . Thus, once again, a slot or void 32 is provided; but in this case, at one end of the patch 5 1, the internal void 32 lies between a pair of wings 44 which extend outwardly near one end 46 of the patch 5 1. Moreover, the length of the wings 44 together with the width of the patch 5 1 are preferably sufficient to fully enwrap a flaccid or semi-erect human male penis so that when the penis achieves a fully erect status, the wings 44 and the adjacent portion of the width of the patch 5 1 shall function as a penile constrictor. Of course, it will be understood that the underside of each of the wings 44, and the underside of the patch 5 1 is delineated at 48 on both sides thereof, are coated with a human skin compatible adhesive. The slot or void 32 is, once again, intended to carry a suitable transdermal agent therein.

Referring now to Figure 7, another form of patch 7 1 is shown. Here, the outer surface 14

of the patch 7 1 is coated with an exfoliation surface 48, which may also be a microdermabrasion

surface. Obviously, the use of such a patch 7 1 is primarily intended for cleansing, and is rather limited for sexual activities, but it may find additional functional applicability during certain medical or foreplay procedures. In Figure 8 , a partial perspective view of a further embodiment of a cutaneous patch 80 is shown, in keeping with the present invention. The view in Figure 8 has been truncated so as to show the presence of various materials, and a preferred arrangement of the materials in preparing the patch. Figure 9 provides additional details on a possible route to manufacturing the

patch shown in Figure 8 .

In this embodiment, upper surface 8 1 is the upper surface of top film 83. Top film 83 is preferably made of a material such as woven or non-woven rayon, such as 3M tape product No. 1529, and has a thickness of 0.14 mm. Raised texture 82 is made of a plastisol, and preferably a viscous liquid plastisol, than may include a variety of additives such as a puff additive, and these materials are well known to

those skilled in the art of printing. It is to be understood that part of the reason for the use of

rayon in top film 83 is that it's fibrous structure provides sufficient texture for the liquid plastisol to

seep into the upper surface 8 1. After curing, the cured plastisol layer has a thickness of

preferably between 0.05 and 10 mm and, and more preferably between 0.1 and 4mm, and is retained within the fibrous structure. As a result of such bonding, it is less likely to peel or flake off, during use. Rayon top film 83 is adhered to a polyurethane film 85 such as 3M tape No. 9836, having a thickness of 0.05 mm, by a medical grade adhesive, shown as layer 84. Film 85 is sufficiently strong, conformable, and water proof (or water resistant), to provide a durable structure that patch 80 will not tear or otherwise degrade during use. Layer 86 is a preferably a medical grade adhesive which is used to keep the upper components bonded to the skin (not shown), once a paper/silicon coated release liner 87, has been removed. Figure 9 depicts a preferred production method for manufacturing a patch sheet 80,

shown in Figure 8 . Figure 9A shows a cross-section of a film 9 1 comprising upper surface 8 1 of a non-woven top film 83, medical grade adhesive 84, and paper and/or silicon coated release film 93. This combination is similar to various grades of non-woven medical tapes, such as those commercially available from 3M. Top film 83 is sufficiently porous and/or absorbent, so that, as is seen in Figure 9B, a liquid plastisol 82 can be applied to the upper surface 8 1 of non-woven film 83. The liquid plastisol 82 is sufficiently viscous so as to remain in place, but is still partially absorbed within the upper surface 8 1 of fibrous layer 83. As such, after curing of plastisol 82, it will not peel or flake off during use. Figure 9B therefore shows a cross-section of the film of Figure 9A that has had a liquid plastisol 82 applied thereto. The plastisol 82 can be applied using traditional application processes, including mesh silk screening or by plate screening, or the like, in order to provide a pattern on the top surface 8 1 of film 83. After the plastisol 82 has been applied, the film shown in Figure 9B is passed through a heat source and heated for a sufficient time to curing plastisol 82. Typically, the plastisol 82 is heated at temperatures of from 90 to 225 °C, for between 5 and 60 seconds, and more typically, at temperatures of from 120 to 175°C, for times between 5 and 25 seconds, depending on the plastisol composition, and the amounts and types of additives used in the plastisol. The times and temperatures used can vary greatly depending on the materials used, the equipment provided, additives, and the like, as would be known to those skilled in the art. After heating, plastisol 82 is cured, and ready for the next stage.

In Figure 9C, release film 93 is removed from rayon film 83 so that adhesive 84 is revealed. Arrow 95 indicates that a further film composition comprising a thin, flexible, durable, water proof polyurethane film 85, a medical grade adhesive 86, and a further paper and/or silicon coated release layer 87, is brought into contact with adhesive layer 84, and thus join the two film assemblies together to form patch sheet 80, as seen in Figure 9D. It is to be noted that film layer 96 can be covered with a top protective layer (not shown) that would have to be removed prior to combining the two film assemblies together, however, this is not always necessary. In Figure 9D, the completed patch sheet product 80 is shown, which is ready to be die- cut into individual patches of a desired shape or size. The length and width of patch sheet 80 can vary depending on the size of the production apparatus used. Typically, though, the overall thickness of patch sheet 80 is preferably less than 10 mm, more typically, between 0.1 and 5 mm, and still more preferably, between 0.2 and 1 mm. Production of the other embodiments of the cutaneous patches of the present invention, will be similar in nature to the process described hereinabove, with suitable materials being substituted or replaced, as required, depending on the design and/or application of the cutaneous patches to be produced.

It will be understood, that the dimensions of any of the cutaneous patches in keeping with the present invention may vary according to their intended purpose, and indeed according to their intended market. Those patches which are intended strictly for use with a finger of a human hand will understandably be smaller, for the most part, then those patches which are intended for use with a human male penis.

Moreover, the shape of any patch in keeping with the present invention is not necessarily

as shown in Figures 1, 2 , or 7 ; but the patches may be oval, circular, square or rectangular, or they may have a zig zag configuration.

The principal design criteria of cutaneous patches in keeping with the present invention are to provide enhanced tactile stimulation during sexual activity, and when desired, to deliver a transdermal agent or the like to the skin of a human male penis, and/or to deliver materials, such as a lubricant or other gel-like substance to the outer surface of the patch. Of course, means are provided including suitable human skin compatible adhesives, as well as tapered periphery of the patches, so as to lessen the chances if not to preclude the risk of dislodgment of the patch from a finger or from the human male penis.

It will be understood that any cutaneous patch in keeping with the present invention should be such that it is ideally hypoallergenic, that it is highly conformable to the finger or human male penis to which it is applied, and that it has strong adhesion thereto. Typically, the material

from which any cutaneous patch in keeping with the present invention is made is non-absorbent.

Moreover, at least the human skin compatible adhesive which is employed so as to maintain any

cutaneous patch in keeping with the present invention in contact with the human skin to which it

has been applied, should retain its adhesiveness when in contact with any of water, soap, lubricants, bodily fluids, or any combination thereof. The dimensions of any cutaneous patch in keeping with the present invention, particularly those which are intended for application to a human male penis, must be such as to not interfere with the sexual activity being undertaken, but the dimensions must be such as to ensure that the delivery of tactile stimulation, pharmaceutical transdermal agents, and/or lubricants and other gel-like substances, is effective. Another objective of the present invention is to provide additional girth, in particular, to an erect human male penis. Studies have shown that the average erect penis length is 14.9 cm with standard deviation of 2 .1 cm, and that the average erect penis circumference or girth is 12.63 cm with standard deviation of .3 cm. However, it is well known that many human males may be well below those typical dimensions; and that those human males and/or their sexual partners may desire at least that the girth of the erect human male penis be enhanced. Thus, cutaneous

patches which are otherwise in keeping with the present invention may be such that their dimensions, including the dimension of thickness, will be such that when the erect human male penis is enwrapped with a patch, the girth of the penis may be increased by preferably at least 1.0 cm, and more preferably, by at least 1.5 cm, or more.

As noted above, particularly when cutaneous patches in keeping with the present invention are intended to deliver the pharmaceutical transdermal agents to an erect human male penis, the cutaneous patch may be employed together with a condom. The function of each of the cutaneous patch and the condom are, in that case, independent one of the other, and neither is compromised by the other.

The modes of manufacture of cutaneous patches in keeping with the present invention are beyond the scope of this invention. However, it may be noted that such manufacturing techniques as die cutting, butt cutting, and/or the use of cutouts, crimping, stamping, and laminating, may be employed as is well known to those skilled in the art. There has been described various cutaneous patches whose purpose is to enhance tactile stimulation during sexual activity, and alternatively so as also to deliver transdermal agents during sexual activity, all as has been indicated above. Some of the cutaneous patches in keeping with the present invention may be employed by females, but for the most part the cutaneous patches are intended for use by males by applying a patch to their penis.

Other modifications and alterations may be used in the design and setup of the present invention, without departing from the spirit and scope of the accompanying claims. Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not to the exclusion of any other integer or step or group of integers or steps. CLAIMS:

1. A patch for cutaneous application to the external surface of a human body for purposes of cleansing, tactile stimulation, or delivery of transdermal pharmaceutical agents, or both; wherein said patch has an underside having at least a portion thereof coated with a human skin compatible adhesive, for application to the skin of said human body; wherein said patch has an outer surface which is distal from the skin when applied to said human body; and wherein said outer surface of said patch is chosen from the group consisting of a textured surface and a smooth surface;

2 . The patch of claim 1 wherein said external surface is the skin of an elongated member of a human body, and is used during sexual activity.

3 . The patch of claim 2 wherein said elongated member of a human body is chosen from the group consisting of a finger of a human hand and a human male penis.

4 . The patch of claim 3 , wherein said patch has a dimension of length which is greater than its dimension of width.

5 . The patch of any one of claims 1 to 4 , further comprising a removable release film initially placed over at least said human skin compatible adhesive for removal therefrom prior to application of said patch to said human body.

6 . The patch of any one of claims 1 to 5 , wherein the material of said patch is chosen from the group consisting of latex, silicone, natural rubber, PVC, plastisol, and plastisol additives including soft-hand extenders or puff additives, polyurethane or other plastic materials such as polyethylene, polypropylene, or the like, cellulosic materials including fibrous cellulosic derived materials, such as rayon or the like, and combinations thereof and therebetween.

7 . The patch of claim 1, wherein when said patch is intended only for application to a finger of a human hand, said outer surface has a textured surface chosen from the group consisting of a plurality of outwardly extending bumps, studs, ridges, hair-like projections, relief patterns, crimps, cut-outs, an exfoliation surface, a microdermabrasion surface, and any combination thereof. 8 . The patch of claim 1, wherein when said patch is intended for application to a human male penis, said outer surface has a textured surface chosen from the group consisting of a plurality of outwardly extending bumps, studs, ridges, hair-like projections, relief patterns, crimps, cut-outs, and any combination thereof.

9 . The patch of claim 8 , comprising at least one transdermal agent applied to the underside of said patch, wherein the at least one transdermal agent is chosen from the group consisting of an erectogenic agent, an agent to induce a warming feeling to the skin of the penis, an agent to induce a cooling feeling to the skin of the penis, an agent to induce a tingling feeling to the skin of the penis, a local anaesthetic agent to induce delayed ejaculation, and combinations thereof.

10. The patch of claim 9 , wherein said transdermal agent is contained in said human skin compatible adhesive.

11. The patch of claim 9 , wherein said transdermal agent is contained in said human skin compatible adhesive, in the form of microcapsules having said transdermal agent incorporated therein.

12. The patch of claim 9 , wherein said transdermal agent is applied to at least a portion of the underside of said patch as a separate layer.

13. The patch of claim 2 , wherein a pair of additional edge layers are applied to the underside of said patch, and said human compatible adhesive is applied to the underside of said additional edge layers; and wherein said transdermal agent is contained in the void which is created between said pair of additional edge layers.

1 . The patch of claim 1, wherein the external periphery of said patch is tapered downwardly from said outer surface to said underside.

15. The patch of claim 8 , wherein the dimensions of said patch, including its thickness, are sufficient so as to add girth to an erect human penis.

16. The patch of claim 15 wherein said patch adds at least 0.2 to 1.5 cm of girth to an erect human penis. 17. The patch of claim 8 , further comprising a pair of outwardly extending wings near one end thereof.

18. The patch of claim 17 , wherein the length of the wings together with the width of the patch are sufficient to fully or partially enwrap a flaccid or semi-erect human male penis so that when the penis achieves a fully erect status said wings and the adjacent portion of the width of said patch function as a penile constrictor.

9 . The patch of claim 7 or 8 , further comprising an internal void therewithin, and an openable release means to permit fluid communication from said internal void to said outer surface; wherein said openable release means is chosen from the group consisting of an adhesively applied release film, a valve which is openable by pulling, a valve which is openable by being squeezed, a frangible film which will break by applying pressure thereto, and a frangible film which will break by being scratched; and wherein said void is filled with a fluid gel-like substance chosen from the group consisting of a lubricant, a flavoured gel, a scented gel, a warming gel, a cooling gel, and combinations thereof.

20. The patch of claim 8 , wherein the material of said patch exhibits the characteristic of

being stretchable in any one of the dimensions of length, width, or thickness thereof, so as to accommodate swelling and engorgement of a human male penis to which it is applied.

2 1. The patch of claim , wherein said human skin compatible adhesive retains its adhesiveness when in contact with any of the group consisting of water, soap, lubricants, bodily fluids, and combinations thereof.

22. A method for the production of a patch for cutaneous application to the external surface of a human body for the purposes of cleansing or for tactile stimulation or for delivery of transdermal agents during sexual activity, wherein said patch is first prepared as a product sheet by a process comprising: a) applying a plastisol to an upper layer of a woven or non-woven film and curing said plastisol to provide a pattern on the upper surface of the woven or non-woven film; b) utilizing an adhesive to attach a lower surface of said upper layer, to an upper surface of a flexible, water proof polyurethane film;