Medication delivering clitoral stimulation device

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.

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' sexuality concerns is no longer taboo. Since the recent
 introduction and success of Viagra therapy for men, womens' 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'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.

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.