Abstract:
The present invention involves a clitoral stimulation apparatus for the holding and timed distribution of a gel or cream onto the clitoris of a user of the apparatus. The apparatus comprises an enclosing body having a first end and a second end, a channel-shaped clitoris-interfacing surface on the first end of the body, and a gel or cream distribution arrangement on the body of the apparatus to permit the user to be clitorally stimulated as desired.

Description:
This application is a continuation-in-part of copending application(s) application Ser. No. 09/340,227 filed on Jul. 1, 1999. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to arrangements for clitoral stimulation, and more particularly to a device for delivering medicaments to the clitoris for a stimulation thereof, and is a continuation-in-part application of my co-pending U.S. application Ser. No. 09/340,227, filed Jul. 1, 1999, and incorporated herein by reference, in its entirety. 
     2. Prior Art 
     Addressing womens&#39; sexuality concerns is no longer taboo. Since the recent introduction and success of Viagra therapy for men, womens&#39; concerns are finally being addressed. The characteristics of the female anatomy require that such stimulating products be in the form of a cream or a gel. 
     In the human anatomy, and more particularly in the female anatomy, there are two types of integument (skin): keratinized stratified squamous epithelium, and non-keratinized stratified squamous epithelium, more commonly referred to as mucous membrane. The entire external surface of the body is covered with keratinized stratified squamous epithelium except the lips, mouth, anus, and the vagina/vulva in females. If a lotion is applied to the keratinized squamous epithelium, it is absorbed only by the top layers of the skin. Multiple transdermal medications are delivered through the keratinized skin, but the delivery system is very sophisticated. Absorption of medications is much easier if they are delivered to mucous membranes, or non-keratinized stratified squamous epithelium, especially the vulva and vaginal mucosa. Many vaginal creams, and suppositories that dissolve to become creams with the moisture and heat of the vagina, have been sold for over fifty years. All of the vaginal creams and suppositories are absorbed into the full thickness of the non-keratinized stratified squamous epithelium that defines the vaginal mucosa. Some of the vaginal creams are systemically absorbed by the blood vessels in the basement membrane of the vaginal mucosa, while other medications are not systemically absorbed. Systemic absorption refers to the distribution of the medication throughout all tissues of the body via the blood stream. The vaginal/vulvac mucosa is a multiple layer of non-keratinized stratified squamous epithelial cells twenty-to-thirty cells in thickness from the basement membrane to the outermost cells of the mucosa. Antifingal creams are absorbed by the vaginal mucosa, where they act to kill monilia, but are not systemically absorbed. Some estrogen creams are systemically absorbed and others are not, but both types have a local growth effect on the vaginal mucosa and are absorbed by the full thickness of the mucosa and even the dermis that supports the epidermis (the vaginal mucosa). 
     Currently, a number of medicated creams are being developed to enable, or to enhance female sexual stimulation and response by direct actions on the clitoris. All of these creams are intended to be topically applied directly to the vulvae and clitoris. The top of the clitoris is covered by the clitoral hood, an extension of the labia minora; any medication applied to the clitoral hood is poorly absorbed because this tissue is partially keratinized stratified squamous epithelium. The under-carriage of the clitoris is a mucous membrane-non-keratinized epithelium—and a medication applied to the undercarriage of the clitoris is well absorbed. The absorption of the medication by the mucous membrane of the clitoris will diffuse into the entire clitoris and be effective. However, the application of a medicated cream specifically to the undercarriage of the clitoris is not only a difficult maneuver because it is done blindly, by feel only; it is also an ineffectual one, because medication placed on the clitoral hood or labia minora will be relatively futile. The misapplication of the medication might lead women to believe the medication is ineffective, when, in reality, it was simply misplaced. In addition, clitoral application might not be well accepted by a number of women because of their unfamiliarity with the vulvar anatomy. Some women might not only be reluctant to attempt to apply a cream directly to the under-carriage of the clitoris, but might also choose not to use the medication cream because of embarrassment. 
     The anatomy of the clitoris and the physiological action of the vasoactive creams for stimulation thereof is generally similar to the anatomy of males. The clitoral artery, located in the middle of the clitoris and extending lengthwise from the base to the tip of the clitoris, supplies blood to the clitoris. Two clitoral veins, located on either side of the clitoral artery, normally drain the clitoris of the blood pumped into it from the artery. As female sexual arousal initiates, either by direct stimulation of the clitoris or by the application of one of the recently developed female arousal creams, valves of the clitoral veins located at the base of the clitoris close, and the venous blood fills two honeycomb-like chambers, the cavernous cavernosa. The corpus cavernosa are normally empty of blood, but, like the clitoral artery and veins, they are positioned lengthwise from the base to the tip of the clitoris. Therefore, as the valves in the veins at the base of the clitoris close, the blood pumped into the clitoris artery distends the corpus cavernosa. This causes the clitoris to enlarge two-to-three fold, and to become erect, rigid, and highly sensitive, just as the penis in the male. In fact, the penis and the clitoris are the exact same structures. Female clitoral enlargement and rigidity and male penile erection are both accomplished by the same action: closure of the venous valves located at the base of each structure. Drugs (like Viagra) that cause closure of these venous valves are classified as vasoactive drugs. Several development programs by major drug companies are currently attempting to produce Viagra-like vasoactive creams to apply to the clitoris to enhance female sexual response. 
     BRIEF SUMMARY OF THE INVENTION 
     The primary function of the present invention is the specific placement of a medication so that it directly interfaces with non-keratinized stratified squamous mucous membrane located on the ventral aspect, or under-carriage, of the clitoris. This exact positioning would be accomplished by use of an adhesive-backed device described in my patent application Ser. No. 09/340,227. The present invention addresses the need for applying and properly positioning a cream or gel-like medication, scented or unscented, flavored or unflavored, against the mucous membrane particularly where the moisture of the tissue causes the medication to dissolve, and because of the lack of keratin, encourages local tissue absorption of that medication. The body heat of 37 degrees centigrade, combined with the mucous membrane serum transudate moisture, acts to dissolve the physiological active ingredients of the medicated cream, and allows the diffusion of the dissolved active ingredient into the clitoral tissue. The absorbed vasoactive cream can then effect the drug-mediated arousal and increased sensitivity of the clitoris. 
     Three types of drug delivery arrangements and stimulator embodiments could be utilized by the adhesive-backed clitoral stimulating device. They are a semi-solid molded cap attached to the clitoral interfacing surface of the device, a cream applied to the clitoral interfacing surface just before the actual use of the device, and a reservoir to hold the cream located within the body of the device with a communicating channel to the surface interfacing with the clitoris. 
     The first embodiment comprises a unique cap design medication applicator. Medicated suppositories are actually a suspension of the active medication within a cocoa butter matrix. The semisolid suppository is inserted into the vagina and dissolves because of the heat and transudate moisture of the vagina. The active ingredient is thus absorbed by the non-keratinized stratified squamous epithelium-the vaginal mucosa. The cap design would actually be preformed, and, by the use of a compatible adhesive, attached to the clitoral interfacing surface of the clitoral stimulating device. Once placed and held in place by the adhesive backing of the clitoral stimulating device, the cocoa butter matrix would dissolve and the active medication would be absorbed by the undercarriage of the clitoris. 
     The second embodiment of the present invention would be an increased surface area on the superior aspect of the medication applicator clitoral stimulating device intended to be positioned against the clitoris. The user would apply a medicated cream directly to the top aspect of the device as a person applies toothpaste to a toothbrush before use. When the device is loaded with medicated cream, it is positioned against the clitoris, and the medicated cream is in direct contact with the non-keratinized stratified squamous eqithelium (the mucous membrane) of the undercarriage of the clitoris. 
     A third embodiment of the present invention would be a pre-loaded reservoir located within the body of the resilient silicone, clitoral-stimulating medicament applicator. The reservoir would contain a channel for the delivery of the medicated cream from the reservoir to the surface interfacing the clitoris. This reservoir would be pre-loaded with a medicated cream, having a distribution channel covered by an adhesive-backed release paper. The user removes the release paper, the medication would cover the surface of the device interfacing with the undercarriage of the clitoris. A pinching force applied to the sides of the applicator as it is placed under the clitoris would squeeze the medicated cream out of the reservoir and apply the cream directly to the clitoris. The pressure exerted on the device from intercourse would also cause continuous release of the medication from the reservoir to the clitoris over a period of time. The reservoir would be constructed with a thin wall, and, due to the elastic properties of the silicone, the reservoir would collapse as it is depleted of medicated cream. The reservoir could be filled with a suppository-like cocoa butter medication as in the cap design of the first embodiment. The medication would be solid or semi-solid at room temperature, but would liquefy at body temperature to allow the medication to exit the reservoir and be applied directly to the undercarriage of the clitoris by the top surface of the device. 
     A further embodiment of the present invention includes a battery powered vibratory generator arranged within the body of the applicator. A pressure, heat or moisture sensitive switch or release may be arranged on a side portion of the applicator to activate the vibratory generator created motion within the applicator before or as it is applied against the clitoris. The vibratory motion of the stimulator has the dual effect of stimulating the clitoris by stimulator motion itself, as well as the effect of pumping or distributing out any cream of gel on or in the stimulator. 
     The invention thus comprises a clitoral stimulation apparatus for the holding and timed distribution of a gel or cream onto the clitoris of a user of said apparatus, comprising: an enclosing body having a first end and a second end; a channel-shaped clitoris-interfacing surface on the first end; and a gel or cream distribution arrangement on the body of the apparatus. The enclosing body is of generally triangular shape having said first end truncated. The gel or cream distribution arrangement includes a gel or cream reservoir arranged within the body of the apparatus. The distribution arrangement may include a conduit from the reservoir to the tissue interfacing surface. The distribution arrangement may include a roughened texture on the channel-shaped clitoral-interfacing surface. The clitoral stimulation apparatus may include a pair of sloped side walls defining the body of the apparatus, against which the vaginal labora minor will rest. A tab may be arranged on the body between the side walls, for gripping and manipulating the apparatus by a user thereof, interfacing surface may have a cap of medicament adhesively attached thereon. The interfacing surface may have an adhesively backed release sheet thereon, to permit discharge of cream or gel through the conduit from the reservoir to the interfacing surface when the release sheet is removed. A vibratory generator may be arranged within the body of the apparatus. The vibratory generator may be activated by a pressure sensitive switch on the body of the apparatus. The vibratory generator may be activated by a heat sensitive switch on the body of the apparatus. The vibratory generator may also activated by a moisture sensitive release on the body of the apparatus. The enclosing body may have a lowermost surface with a tissue adhering adhesive thereon for securement of the apparatus to a user of the apparatus. 
     The invention also includes a method of stimulating a clitoral organ of a user by the application of a clitoral tissue stimulating medicament to the clitoral tissue, comprising the steps of: providing a clitoral interfacing apparatus with a clitoral interfacing surface; applying a clitoral stimulating medicament onto the clitoral interfacing surface; and placing the apparatus against the user&#39;s clitoris to permit the medicament to engage and effect the clitoris. The steps include arranging a medicament holding reservoir within the apparatus; and connecting the reservoir and the interfacing surface by a conduit; placing a vibratory generator within the apparatus to permit a vibratory motion to be switched on in the apparatus, on by the user. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The objects and advantages of the present invention will become more apparent when viewed with the following drawings, in which: 
     FIG. 1 is a plan view of a clitoral stimulation applicator of the present invention; 
     FIG. 2 is a view taken along the lines  2 — 2  of FIG. 1; 
     FIG. 3 is a view taken along the lines  3 — 3  of FIG. 1; 
     FIG. 4 is a view taken along the lines  4 — 4  of FIG. 1; 
     FIG. 5 is a perspective view of the clitoral stimulation applicator shown in FIG. 1; and 
     FIG. 6 is a representation of the applicator arranged in position against a clitoris. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring now to the drawings in detail, and particularly to FIG. 1, there is shown the present invention comprises a clitoral stimulating medication applicator  10  preferably made from a silicon having a shaped somewhat in a triangular configuration having a truncated first end  12 , and a broadened second end  14 , as may be seen in FIG.  1 . The first end  12  is channel shaped so as to provide a conforming notch-like surface “S” to engage with the interfacing surface of a clitoris “C”. The stimulating applicator  10  has sloped side walls  16  and  18  arranged to be covered by the labia minor. The stimulator applicator  10  has a planar lower surface  20 , as shown in FIGS. 2,  3  and  4 . The lower surface  20  is preferably covered with a mild adhesive “A” for securement to the stimulator applicator “user”, which securement arrangement is identified in my aforementioned co-pending U.S. Patent Application. A tab  22  is molded into the ridge line between the two sloped side walls  16  and  18 . The first end  12  of the applicator  10  in a first preferred embodiment has a layer or cap  26  of a medicated suppository thereon. Such medicated suppositories are actually a suspension of an active medication within a cocoa butter matrix and dissolves when placed against the clitoris because of the heat and transudate moisture of the vagina. The active ingredient is thus absorbed by the non-keratinized stratified squamous epithelium-the vaginal mucosa. The cap  26  may be made as a medicated suppository which is actually a suspension of an active medication within a cocoa butter matrix. The semisolid suppository is inserted into the vagina and dissolves because of the heat and transudate moisture of the vagina. The active ingredient is thus absorbed by the non-keratinized stratified squamous epithelium-the vaginal mucosa. The cap  26  may be actually be preformed, and, by the use of a compatible adhesive, attached to the clitoral interfacing surface “S” of the clitoral stimulation applicator  10 . Once placed and held in place by the adhesive backing of the clitoral stimulating device, the cocoa butter matrix would dissolve and the active medication would be absorbed by the undercarriage of the clitoris. 
     The second embodiment of the clitoral stimulation medication applicator  10  includes a surface “S” having depressions or a roughened surface  30 , which would entrap and hold a medicated cream directly to the top aspect of the device as a person applies toothpaste to a toothbrush before use. When the device is loaded with a medicated cream “M”, it is positioned against the clitoris, and the medicated cream is in direct contact with the non-keratinized stratified squamous eqithelium (the mucous membrane) of the undercarriage of the clitoris. 
     Another preferred embodiment of the clitoral stimulator  10  is a pre-loaded reservoir  34  located within the body  36  of the resilient silicone, clitoral-stimulating medicament applicator. The reservoir  34  would contain at least one channel  38  for the delivery of the medicated cream “M” from the reservoir  34  to the surface “S” interfacing the clitoris. This reservoir  34  would be pre-loaded with a medicated cream “M”, having its distribution channel(s)  38  covered by an adhesive-backed release paper  40 . The user removes the release paper  40 , and the medication “M” would then cover the surface “S” of the applicator  10  interfacing with the undercarriage of the clitoris. A pinching force applied to the soft sidewalls  16  and  18  of the applicator  10  as it is placed under the clitoris would squeeze the medicated cream “M” out of the reservoir  34  and apply the cream directly to the clitoris. The pressure exerted on the device from intercourse would also cause continuous release of the medication from the reservoir  34  to the clitoris over a period of time. The reservoir  34  would be constructed with a thin wall, and, due to the elastic properties of the silicone, the reservoir  34  would collapse as it is depleted of medicated cream. The reservoir could be filled with a suppository-like cocoa butter medication as in the layered cap  26  of the first embodiment. The medication “M” may be solid or semi-solid at room temperature, but would liquefy at body temperature to allow the medication to exit the reservoir  34  and be applied directly to the undercarriage of the clitoris by the interfacing surface “S” of the device. 
     A further embodiment of the present clitoral stimulator  10  includes a battery powered vibratory generator  50  arranged within the body  36  of the applicator  10  as indicated in FIG. 1. A pressure, heat or moisture sensitive switch or release  52  may be arranged on a side portion of the applicator  10 , and communicating through a proper circuit  54 , to activate the vibratory generator created motion within the applicator  10  before or as it is applied against the clitoris. The vibratory motion of the stimulation applicator  10  has the dual effect of stimulating the clitoris by stimulator motion itself, as well as the effect of pumping or distributing out any cream of gel on the surface “S” or in the reservoir  34  of the stimulation applicator  10 . 
     FIG. 6 represents the emplacement of a stimulation applicator  10  against a clitoris “C” on a user of such device. 
     Thus there has been shown a unique clitoral stimulation apparatus for holding/supporting and distributing a stimulatory gel, cream or medicament to the clitoris of a user of such apparatus. Such apparatus includes vibratory means to facilitate stimulation of the clitoris and for the timed application of medicament to the clitoris as well.