Patent Application
20070021809
1. Field of the Invention
The present invention relates to the field of treatment of feminine disorders and more particularly to the treatment of the symptoms of inflammation or irritation to a woman's genitals.
2. Description of Related Art
There are many conditions that may affect a woman's vagina causing discomfort. A broad category of such afflictions is vaginitis which is defined as an inflammation of the vagina characterized by discharge, odor, irritation and itching or a combination of these. Vaginitis is often caused by infections. The most common vaginal infections are bacterial vaginoisis, trichomoniasis and vaginal yeast infection or candidiasis. Symptoms of vaginitis, particularly with trichomoniasis and vaginal yeast infection, include irritation and itching of the female genital area including itching, burning and irritation of the vagina.
Vaginitis is one of the most common problems in clinical medicine and accounts for more than 10 million office visits each year. (Kent, Howard L. “Epidemiology of Vaginitis,” American Journal of Obstetrics and Gynecology 165, no. 4, part 2 (October 1991): 1168-76.) Vaginitis is reported to be the most common reason for a patient to visit her obstetrician-gynecologist. Id. A study conducted by B. Foxman, R. Barlow, H. D'Arcy, B Gillespie and JD Sobel at the Department of Epidemiology, University of Michigan School of Public Health Studies (Foxman B, Barlow R, D'Arcy H, Gillespie B, Sobel JD, “Candida vaginitis: self-reported incidence and associated costs,” Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor 48109-2029, USA) showed that a total of 6.5 percent of women older than 18 years reported a least one episode of presumed vaginitis during the previous 2 months. That same study showed that 8.0 percent of the women reported having four or more episodes of vaginitis in a 1-year period. Although these women accounted for only 8.0 percent of the sample, they accounted for 37.2 percent of women reporting episodes.
Vaginitis is found in 28% of women attending sexually transmitted disease (STD) clinics; sexually active women are at an increased risk for vaginitis because the presence of semen in the vagina may raise the pH and thereby allow for a proliferation of pathogenic anaerobic bacteria. Epidemiology of Vaginitis at Id. Candidiasis is the second most frequent vaginal infection in the United States and the primary vaginal infection in Europe. Id. The late Herman Gardner put the human toll of vaginitis in perspective when he stated, “Vaginitis must cause more unhappiness on earth than any other gynecologic disease. In addition to the many physical and emotional problems associated with vaginitis, the economic loss involved is of astronomic proportions.” (Kaufman RN, Freidrich EG, Gardner HL. Benign diseases of the vulva and vagina. 3rd ed. Chicago: Year Book Medical Publishers, 189:361-418.)
Treatment for the various presentations of vaginitis usually includes the application of antibiotics or acidophilus or both, usually orally. Also, where the inflammation or irritation is present in the vagina, antifungal medications are often used. These antifungal treatments come in the form of creams, tablets or suppositories such as boric capsules. These treatments are typically applied several times a day for several weeks. A disadvantage of these treatments is that relief from the vaginitis symptoms takes several days or weeks to occur.
Some women find relief from the symptoms of vaginitis from the application of an acidophilus-containing yogurt douche. This treatment is typically applied daily for a few days or weeks depending on the severity of the infection. This treatment has at least the disadvantage of being somewhat messy and again taking a relatively long time to be effective and provide relief.
Also, women who have a yeast infection (or are predisposed to such infections) are often advised to limit their intake of sugar, fruit juices and refined carbohydrates. For persistent or recurrent infections, some doctors recommend that fruit also be avoided. While these lifestyle changes may ultimately be effective in treating or reducing the incidence of vaginitis, these benefits take a long time to come into effect after the lifestyle changes are made.
In any event, there is often a delay from the time treatment is begun until relief, particularly significant relief, from the symptoms is found. As a result, women with vaginitis, even after receiving treatment, continue to experience the symptoms of irritation, itching and burning of the female genitals generally and the vagina specifically.
Another broad category of conditions that may affect a woman's genitals and vagina is inflamed vaginal and vulvar tissue resulting from trauma or irritation. This inflammation may result from trauma or irritation from sexual activity especially due to increased sexual activity, sexual activity with inadequate vaginal lubrication especially in post menopausal women and sexual activity for many post menopausal women who have decreased elasticity in their vaginal tissues. This inflammation may also be present in post-partum women as a result of the trauma or irritation from the childbirth process. There are other conditions or reasons that a woman might experience vaginal inflammation. The treatments for vaginal inflammation resulting from other conditions or reasons mirror the treatments described above.
Treatments for this inflammation, whatever the source, include the application of topical creams or lotions and tablets or suppositories and the application of cool or warm compresses. These treatments are typically applied several times a day for several weeks. A disadvantage of these treatments again is that little significant relief occurs immediately and ultimate relief from the symptoms takes several days or weeks to occur.
The treatments described above in connection with the variety of maladies of the female genitals and vagina typically have the further disadvantage of often requiring the user to obtain a prescription from her physician and then getting the prescription filled at a pharmacist before being able to apply the therapy. Both of these actions take time and money. Often, the woman suffering from these afflictions seeks more immediate relief, especially relief that is cheaper and easier to obtain. Consequently, there exists a need for a cheap, easy, accessible and reliable treatment for these maladies of the vagina and vulva.
The present invention is a device and therapeutic method that provides topical cooling or heating to a user's vagina or vulva as a therapeutic benefit to and relief from maladies of these areas. The device includes a protrusion that is placed into the user's vagina and a base that contacts the female genitals around the vagina. The device is cooled or heated prior to or during use. The method includes the use of the device to provide a therapeutic effect and relief from maladies of a user's vagina or vulva.
It is therefore an object of the invention in one embodiment to provide topical cooling or heating to a user's vagina or vulva or both.
It is an object of the invention in one embodiment to provide a method of treating inflammation or irritation to a woman's genitals.
It is an object of the invention in one embodiment to provide a method of treating vaginitis.
It is an object of the invention in one embodiment to provide a method of treating inflamed vaginal and vulvar tissue resulting from trauma or irritation.
It is an object of the invention in one embodiment to provide a method of treating inflamed vaginal and vulvar tissue resulting from sexual activity with inadequate vaginal lubrication especially in post menopausal women and from sexual activity for post menopausal women who have decreased elasticity in their vaginal tissues.
It is an object of the invention in one embodiment to provide a method of treating inflamed vaginal and vulvar tissue resulting from increased sexual activity.
It is an object of the invention in one embodiment to provide a method of treating inflamed vaginal and vulvar tissue in post-partum women resulting from trauma or irritation from the childbirth process.
It is an object of the invention in one embodiment to provide a method of treating inflamed vaginal and vulvar tissue in non-human animals resulting from trauma or irritation.
These and other objects of the invention will be clear from the description of the invention given herein.
The invention is shown in the Figures generally labeled 10. The device comprises an elongated projection 12 attached to a base 14. Throughout the description, like reference numbers, wherever referred to and regardless of the embodiment particularly described in association therewith, unless specifically stated otherwise, refer to like elements. The properties, characteristics or attributes of such elements described in connection with a specific embodiment or a variant within a specific embodiment apply to similarly referenced elements even if used in connection with alternate embodiments or variants unless specifically stated otherwise.
The projection 12 is a protrusion that has a distal end 16, a proximal end 18 that is attached to base 14 and a projection outer surface 20. Projection 12 is preferably hourglass shaped so that the diameter “D” of projection 12 between distal end 16 and proximal end 18 at narrowing 22 is somewhat less than the diameters of either distal end 16 or proximal end 18.
Although the projection 12 is preferably hourglass shaped, it is not required to be. In fact, projection 12 may have a constant diameter or increasing or decreasing diameter going from the distal end 16 to the proximal end 18. Further, projection 12 may be straight or curved as desired to give the most comfortable and effective fit between the projection 12 and the walls of the vagina when the device 10 is in operation as will be described hereafter. The distal end 16 of projection 12 is preferably rounded to facilitate its insertion into the user's vagina.
As stated, the projection 12 in operation will be inserted into the user's vagina. In the embodiment of projection 12 having a narrowing 22, narrowing 22 is located so that that narrowing 22 will be located at the ringlet muscles of the vagina when the projection 12 is inserted into the vagina. This configuration allows the surface of projection 12 to have maximal contact with the tissue of the vagina on either side of the “ringlet muscles” of the vagina.
It is well understood that women have varying anatomy with respect to aspects of their genitals including vaginal length. Some of this anatomy statistically depends on the size and age of the woman as well as the woman's race. As a result, the length of the projection 12 and the location of the narrowing 22 or both that will work best for one woman will not necessarily work well for another. Because of this, it is anticipated that the device could be offered in a variety of dimensions of projection 12 and location of narrowing 22 (
These dimensions for length L have been given as exemplary and are not intended to be limiting. Instead, the maximum length L for the projection 12 could be as long as desired to provide comfort to the user but not so long as to provide discomfort for, among other reasons, the distal end 16 of the projection contacting the user's cervix. Likewise, the location of narrowing 22 should ideally be located at a point most comfortable to the user and may vary from woman to woman along nearly the entire length L of projection 12.
Also, it is clear that because women have varying anatomy, projections 12 of varying diameter as part of the device 10 in use will be more or less comfortable to the user. As a result, it is also anticipated that the device 10 may be offered with a variety of diameters for projection 12 as well. An example of a typical diameter “D” of projection 12 is about 0.9375 inches with a typical diameter of the narrowing 22 of about 0.75 inches.
Once again, the diameter D of projection 12 could be as small as being close to non-existent. Conversely, it is anticipated that a good representative range of diameters D for projection 12 to cover most women regardless of their race or size would be approximately ⅔ of the preferred diameter (approximately 0.625 inches) to 1.5 times the preferred diameter (approximately 1.406 inches) with the corresponding diameter of narrowing 22 ranging also from ⅔ of the preferred diameter (approximately 0.5 inches) to 1.5 times the preferred diameter (approximately 1.125 inches).
These dimensions for diameter D have been given as exemplary and are not intended to be limiting. Instead, the maximum thickness D for the projection 12 could be as wide as desired to provide comfort to the user but not so wide as to provide discomfort for, among other reasons, the stretching of the vagina. Likewise, the diameter of narrowing 22 should ideally be such that it is most comfortable to the user and may vary from woman to woman from virtually nothing to maybe include being larger than the diameter D of the projection 12. Further, the diameter D of projection 12 on the distal end 16 of projection 12 may be different than the diameter D of projection 12 in the proximal end 18 of projection 12.
In summary, although dimensions of projection 12 (
Base 14 is preferably slightly curved and relatively thin. Base 14 has a contact surface 24, a back surface 26, a bottom end 28 and a top end 30 as well as a base outer surface 32 that is the ultimate “skin” of the base. An outer edge 34 extends around the periphery of base 14. The proximal end 18 of projection 12 attaches to the contact surface 24 of base 14 near the bottom end 28. Base 14 preferably has a width “W” somewhat larger than its thickness “T”. The width W of base 14 is preferably about 1.875 at the bottom end 28, 1.625 inches at the top end 30 and about 1.25 inches midway between the bottom end 28 and the top end 30. The length of base 14 from bottom end 28 to top end 30 is typically about 4.75 inches. The thickness T is typically about 0.25 inches. It is also preferable, although not required, that base 14 have a curvature from the bottom end 28 to the top end 30 in order to conform more closely to the user's anatomy. A typical curvature for base 14 is a radius of about 3.375 inches centered on the distal end 16 of the projection 12.
Contact surface 24 has a ridge 36 running from the projection 12 toward the top end 30. Ridge 36 has a peak 38 that is most displaced from the contact surface 24 of base 14. Ridge 36 has a low height at its peak 38 that tapers to near the outer edge 34. The contact surface 24 with ridge 36 is intended to conform approximately to the shape of the tissue of the vulva between the user's labia. A typical height for peak 38 is about 0.75 inches.
Although dimensions of base 14, including ridge 36 and peak 38, have been given as typical or representative examples (
The device 10 may be constructed so that the projection 12 and base 14 are integrally formed or the projection 12 and base 14 may be made separately and then attached together by means well understood in the art, including but not limited to, adhesives, heat staking, frictional fit, threaded connection, hook and loop connectors, detents and mechanical catches.
As mentioned, projection 12 is connected to base 14. This configuration results in projection 12 protruding from the contact surface 24. Projection 12 preferably protrudes from base 14 at an angle α of between about 45°-90° and most preferably about 73° to approximate the anatomical angle of the user's vagina relative to the external surface area around the vagina. But, it is clear that because women have varying anatomy, the angle α may vary to provide the utmost comfort and effectiveness for an individual woman. So, although an exemplary range for angle α has been given, any angle α that allows the device 10 to come into close physical contact, preferably close, comfortable physical contact, with the user's vagina or vulva or both is within the scope of the invention.
A key function of the device 10 is that it be cool or warm in use to provide maximum benefit and relief to the user. Consequently, device 10 must be made of a material that is capable of being cooled or warmed and remaining cold or warm, respectively, during use. In one embodiment, the material of device 10 has a high heat capacity so that once the device 10 is cooled or warmed prior to use, as will be described hereafter, device 10 will remain cool or warm, respectively, through use of device 10.
In another embodiment of the invention, device 10 is cooled or warmed during use as also will be described hereafter. In this embodiment device 10 is preferably made of a material with a low heat capacity so that the material will readily be cooled or warmed during use. In either of these embodiments, the projection outer surface 20 of the device 10 will come into contact with delicate tissue of the user in and near the user's vagina. As a result, it is also important that at least the projection outer surface 20 be made of material that is non-reactive with the tissue it comes into contact with. Further, it is preferable that the projection outer surface 20 be smooth to facilitate insertion into and contact with the user's vagina.
In the embodiment of device 10 shown in
In a variant of this embodiment shown in
Also as shown in
Although the embodiment shown in
In a further variant of this embodiment shown in
Access to projection cavity 40 is provided by removing a portion of projection outer surface 20 (
Alternately, as shown in
Where a projection access door 50 is provided to provide access to inner projection cavity 40, as shown in
In an additional variant of this embodiment shown in
Access to base cavity 42 is provided by removing a portion of base outer surface 32 through removal of either the bottom end 28 (
Alternately, the contact surface 24 of base 14 may be separated from the back surface 24 of base 14 along outer edge 34 (
Where a base access door 56 is provided to inner base cavity 42, a portion of base outer surface 32 may be the removable to create base access door 56 (
As mentioned, in the embodiments having a removable projection inner core 48 or removable base inner core 54, the removable projection inner core 48 is placed entirely within projection cavity 40 filling projection cavity 40 and the removable base inner core 54 is placed entirely within base cavity 42 filling base cavity 42, respectively. In these embodiments, the removable projection inner core 48 or removable base inner core 54 may be separated from projection cavity 40 and base cavity 42, respectively, cooled or warmed and then replaced in projection cavity 40 and base cavity 42, respectively, to cool or warm, respectively, the projection outer surface 20 and base outer surface 32, respectively. Alternately, the removable projection inner core 48 or removable base inner core 54 may be retained in projection cavity 40 and base cavity 42, respectively, and cooled or warmed as part of the cooling or warming, respectively, of the device 10 generally.
It is clear that the embodiments of device 10 containing a removable projection inner core 48 and its corresponding projection cavity 40 and removable base inner core 54 and its corresponding base cavity 42 can be combined into a single device 10 having both a removable projection inner core 48 and its corresponding projection cavity 40 and removable base inner core 54 and its corresponding base cavity 42.
As stated, a key function of the device 10 is that it be cool or warm in use to provide maximum benefit and relief to the user. One way to accomplish this cooling or warming is to place device 10 in an environment that is cold or warm and then letting the interaction between the device 10 and the cold or warm environment cool or warm the device 10. One such cooling environment is a refrigerator or freezer. Most homes have both a refrigerator and either an integral or separate freezer. In this embodiment, the device 10, in whatever form it takes, is intended to be placed in either the refrigerator, freezer or other cold environment and thereby cooled. One such warming environment is an oven or warm water bath or in a device to heat the device 10 or portions thereof such as a microwave oven. Most homes have an oven or a microwave oven or have warm water. In this embodiment, the device 10, in whatever form it takes, is intended to be placed in either a conventional or microwave oven or in a warm water bath or other warm environment and thereby warmed.
Device 10 may also be cooled or warmed sufficiently to be therapeutic and comforting to the user by means other than placing device 10 in a cold or warm environment until device 10 is cooled or warmed. Another way this cooling or warming can be accomplished is through the use of a Peltier module, sometimes called a heat pump or, in a cooling mode, an active Peltier refrigerator or Peltier cooler or in a warming mode a Peltier heater. A Peltier module includes a Peltier circuit (
A Peltier circuit uses the Peltier effect. The Peltier effect is the creation or removal of heat occurring when an electric current from a power source I is passed through two dissimilar metals or semiconductors A, B connected together at two junctions J1, J2. The electric current drives a transfer of heat from one junction to the other. This causes one junction to heat up while the other junction cools off. Heat sinks are often placed in association with each junction. These heat sinks become cold or hot, respectively. Peltier circuits are quite compact, reliable and efficient.
In the embodiment shown in
Power source 64 may be either a battery or a power supply that receives power from common household electrical current Switch 70 is preferably located conveniently for the user such as on the back surface 26 of base 14 or on either the first or second connection wires 66, 68.
In a variant of this embodiment shown schematically in
Finally, in a further embodiment shown in
Because of the personal nature of the use of the device 10, in one embodiment of the invention, shown in
Another embodiment of the device 10 shown in
The kit 94 may also include one or more condoms 100 for assuring sterility of the device 10. The use of a condom 100 with the device 10 may be especially appropriate for post-partum use because the cervix may still dilated and therefore susceptible to the introduction of bacteria or other unwanted agents by the projection 12.
In one embodiment of the device 10, the device 10 is intended to be reusable. In this embodiment, because of the material of which device 10 is made, device 10 is intended to be cleansed with soap and hot water or with an approved disinfectant like hydrogen peroxide. Thereafter, the device 10 should be dried and readied for cooling or warming preparatory to its next use.
In another embodiment, device 10 is disposable. In this embodiment, after each use of device 10 the device 10 is discarded. However, in this embodiment, the container 86 used to contain device 10 may be reused or may also be disposed of with device 10.
In use where the device 10 is cooled prior to use, device 10, of course, must be cooled prior to use. One way of accomplishing this cooling is by putting device 10 in a cool or cold environment such as a refrigerator or freezer, either with or without a container 86, and letting the device 10 cool to the desired temperature. Where the freezer has a temperature lower that that desired for ultimate use of the device 10, the freezer may be used to cool the device to a desired temperature and then removed from the freezer before the device 10 cools to a temperature lower than desired.
Another way of cooling device 10 is to cool the removable projection inner core 48, removable base inner core 54 or both by placing them, or them with a container 86, in a refrigerator or freezer until they are at the desired temperature. Prior to use, removable projection inner core 48, removable base inner core 54 or both, in their cool or cold condition, are placed in projection cavity 40 or base cavity 42, respectively.
A further way of cooling device 10 is to place ice, cold water or both into the respective projection cavity 40 or base cavity 42 prior to use. The objective of these methods of cooling device 10 prior to use is to get device 10, particularly the projection outer surface 20 and base outer surface 32 to the desired temperature to produce optimum relief. It is believed that this temperature range extends from about 15° F. to about 50° F. to with a temperature of about 25° F. believed to be most preferred.
An additional way of cooling device 10 is to activate the Peltier circuit so that cooling will begin. When using the embodiment of device 10 with a Peltier circuit, it is desirable to activate the Peltier circuit by activating the switch 70 or switch 80 so that the device 10 can be cooled to the desired temperature prior to use.
In use where the device 10 is warmed prior to use, device 10, of course, must then be warmed prior to use. One way of accomplishing this warming is by putting device 10 in a warm or hot environment such as a an oven or warm water bath or in a device to heat the device 10 or portions thereof such as a microwave oven, either with or without a container 86, and letting the device 10 warm to the desired temperature. Where the oven or warm water bath has a temperature higher that that desired for ultimate use of the device 10, the oven or warm water bath may be used to heat the device to a desired temperature and then removed from the oven or bath before the device 10 warms to a temperature higher than desired.
Another way of warming device 10 is to warm the removable projection inner core 48, removable base inner core 54 or both by placing them, or them with a container 86, in an oven or warm water bath until they are at the desired temperature. Prior to use, removable projection inner core 48, removable base inner core 54 or both, in their warm condition, are placed in projection cavity 40 or base cavity 42, respectively.
A further way of warming device 10 is to place warm water or other warm liquid into the respective projection cavity 40 or base cavity 42 prior to use. The objective of these methods of warming device 10 prior to use is to get device 10, particularly the projection outer surface 20 and base outer surface 32 to the desired temperature to produce optimum relief. It is believed that this temperature range extends from about 97° F. (low end of normal human core body temperature) to about 110° F. (upper end of normal topical heat toleration) with a temperature between about 100°-105° F. believed to be preferred and a temperature of about 103° F. believed to be most preferred.
An additional way of warming device 10 is to activate the Peltier circuit so that warming will begin. When using the embodiment of device 10 with a Peltier circuit, it is desirable to activate the Peltier circuit by activating the switch 70 or switch 80 so that the device 10 can be warmed to the desired temperature prior to use.
Once the device 10 is cooled or warmed to the desired temperature, the projection 12 is inserted into the user's vagina (
As the projection 12 is moved farther into the user's vagina, the ridge 36 will come into contact with the user's vulva between the labia. The peak shape of ridge 36 conforms with the user's anatomy to bring the ridge 36 and the contact surface 24 into conformal contact with the user. Because the projection 12 and base 14 are cool or warm, the therapeutic benefits of this cool or warm contact will be felt by the user both within the vagina and in the vulva area.
If the device 10 eventually ceases to be cool or warm enough to provide the desired therapeutic benefit or comfort, the user may remove the device 10. Where the device 10 is reusable, the device 10 may be recooled or rewarmed and thereafter reused. Where the device 10 is disposable and the user desires to continue treatment, the user should cool or warm another device 10 as described above and use the device as described above. Where the device 10 uses a Peltier circuit, the Peltier circuit can continue to provide cooling or warming while in place in contact with the user's genitals.
Particularly where the device 10 is cooled to a temperature below freezing, it may be desirable to put a protective cover over at least a portion of the device 10 to prevent the device 10 and moist tissue of the user from sticking. This protective cover could be a condom 100 or a condom-like sheath made of paper, cardboard or cloth. It may also be desirable to provide the protective cover described above when the device 10 is used as a warming device.
Although the device 10 has been described as having both a projection 12 and a base 14, it is also within the scope of the invention for the device 10 to have only a projection 12 (
The invention heretofore has been described primarily in connection with embodiments directed to human use. However, the underlying principle of the device applies to all females and vaginitis associated with their genitals and specifically with their vulvas. Consequently, the invention described herein could be adapted for use in animals as well, both for treating vaginitis and other vulvar related inflammation, irritation and itching, but also to warm the vulva and vagina to aid in or as an inducement for mating. It is clear that because of the wide range in sizes and anatomies associated with the various female animals the present invention could be applied to that the specific dimensions of the device 10 will have to be adjusted, according to the principles set out in the description herein, to the animals who will use the device 10.
The invention has been described herein in connection with specific embodiments and dimensions. It is to be understood, however, that the description given herein has been given for the purpose of explaining and illustrating the invention and are not intended to limit the scope of the invention. It is to be further understood that changes and modifications to the descriptions given herein will occur to those skilled in the art. Therefore, the scope of the invention should be limited only by the scope of the following claims.
