Surgery – Sexual appliance
Reexamination Certificate
1999-10-07
2001-05-01
O'Connor, Cary (Department: 3736)
Surgery
Sexual appliance
Reexamination Certificate
active
06224541
ABSTRACT:
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
40 J's LLC
Halgren Don
O'Connor Cary
Szmal Brian
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