Surgery – Female reproductory tract shields – supports – or birth...
Reexamination Certificate
1998-11-06
2001-04-17
Brown, Michael A. (Department: 3764)
Surgery
Female reproductory tract shields, supports, or birth...
C128S837000
Reexamination Certificate
active
06216697
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention discloses a device, a kit and a method for simultaneously delivering at least one beneficial agent to both the cervical and vaginal lumen sides of a vagina. The device is made of a flexible circular rim and a flexible dome. The device can exist in either a relaxed state or in a compressed state. In the compressed state, multiple pouches are formed for carrying and delivering the beneficial agent to both the cervical and vaginal lumen sides of the vagina.
2. Description of the Related Art
Beneficial agents are defined herein as a medicinal component or components to be delivered to the female genital tract. Such beneficial agents include spermicides, bactericides, viricides, fungicides, anti-protozoal agents, hormones, nucleic acids, proteins, enzymes, vaccinogens, antibodies or cytokines, peptides, metal chelators, buffers and the like. Thus, beneficial agents as used herein include protective agents and treating agents and are sometimes referred to herein simply as the agent or agents.
There is a need for a vaginal device that can deliver substantial volumes of a beneficial agent in the form of a gel, cream, lotion, powder or other form, and distribute the agent(s) to all regions of the female genital tract, including the introitus, vagina and cervix, while providing a mechanical barrier that covers the cervix (see FIG.
1
). Current devices are not well suited for this task.
Contraceptive diaphragms, for example, the Ortho ALL-FLEX® diaphragm, and related devices easily contain on their concave surface, and deliver to the cervical region of the vagina, substantial volumes (up to 10 ml) of contraceptive spermicides (see FIGS.
1
and
2
). An agent applied to this concave surface is not wiped off during insertion into the vagina since compression of the diaphragm in preparation for insertion surrounds the spermicide fully in an enclosed pouch in the interior of the compressed diaphragm.
However, contraceptive diaphragms and related devices are poorly suited for delivering spermicides and other beneficial agents to the rest of the vagina, the vaginal lumen side of the device, the region directly exposed to ejaculated semen. If an agent is applied to the diaphragm's convex surface, much of the agent is “wiped off” by the vaginal introitus as the diaphragm is being inserted (see FIGS.
1
and
2
). The tone of the circumvaginal muscle located just inside the introitus enhances this wiping off action by constricting the vaginal barrel. Also, since this circumvaginal muscle tone is highly variable between individual women, it not only limits delivery of an agent on this side of a diaphragm, but causes potentially wide variations of the dose of a beneficial agent actually delivered to the non-cervical region of the vagina.
Cervical caps suffer limitations similar to those of diaphragms. Vaginal sponges can prevent the wipe-off problem, but do not form secure cervical barriers, and sponges may be felt, particularly by the male partner during intercourse as obstructions of the vaginal barrel. A device known as FemCap™ allows better delivery of agent on both sides than most of these other devices. However, FemCap™ sequesters a large portion of the agent applied to the non-cervical side of the vagina in a rather inaccessible crevice, limiting the agent's distribution to the vaginal mucosa. Moreover, unlike the present invention, FemCap™ does not extend upon insertion to distribute the agent over a wide area.
The need to deliver beneficial agents to the cervical side of the vagina is obvious when the goal is contraception, holding a spermicide near the cervix places the spermicide in excellent position to prevent sperm from ascending the cervical os (opening). Although previously not widely recognized, delivering an agent to the non-cervical regions of the vagina (in addition to the cervical region) is also important. When the goal is contraception, spermicide delivered on the vaginal side of a cervical barrier device will be positioned at the site where semen is deposited during intercourse. Thus, the semen will be directly exposed to and mixed with the spermicide. This result will speed the inactivation of sperm. The increased speed of sperm inactivation will provide more reliable contraception and might also allow the user the convenience of being able to remove the device sooner after intercourse.
When the goal is the prevention of sexually transmitted diseases (STD), adequate delivery and distribution of the agent, e.g., a microbicide, to the non-cervical region of the vagina is even more beneficial. While some STD pathogens must contact or ascend the cervix to cause disease, many others can directly infect the cells of the entire vaginal surface, for example, Herpes Simplex Virus,
Haemophilus ducreyi, Treponema pallidum,
Human Papillomavirus and Human Immunodeficiency Virus. Reliable prevention of these infections requires coating the mucosa of the entire vagina with the protective agent, not just delivering the agent to the cervical region covered by the barrier device. Finally, when the goal is treatment of an established condition, it is again beneficial to coat all regions of the vagina with the treating agent.
These considerations are even more important when it is necessary or desirable to deliver a relatively large volume of agent to all regions of the vagina. One reason that this may be necessary or beneficial is the need to assure wide distribution and complete coverage of all regions of the vagina in order to provide effective treatment or prevention to all areas. The surface of the vagina has many small folds (rugae) and increasing the delivered volume aids in assuring coverage of all these folded surfaces. A second reason is to deliver an agent with limited potency, which requires that the device deliver a large volume to achieve an effective dose. Moreover, if a large volume is employed, it is advantageous to have a means of removing this large volume after its use in order to avoid absorption or discharge of the agent from the vaginal introitus.
The present invention is a vaginal device that can be preloaded with an agent and sealed in a package specifically designed to be used with the device. The invention also provides a means to deliver and distribute a substantial volume of an agent to all regions of the vagina. It also provides an efficient means of removing most of the agent along with the device when it is removed from the vagina after use.
SUMMARY OF THE INVENTION
The present invention discloses a device, a kit and a method for simultaneously delivering at least one beneficial agent to both the cervical and vaginal lumen sides of a vagina. The device is made of a) a flexible circular rim having an inner rim surface, an outer rim surface and a cross-sectional profile with a rim height greater than the rim width and b) a flexible dome having a multiply-folded surface (akin to a hat such as a sombrero). The device exists in either a relaxed state or in a laterally compressed state. In the compressed state, the multiple folds in the dome form at least one pouch above the rim and at least two pouches below the rim.
In a preferred embodiment, the cross-sectional profile of the rim is greater than about 1.5:1 (height:width). In a more preferred embodiment, the cross-sectional profile of the rim is less than 12 mm in height. In a most preferred embodiment, the cross-sectional profile of the rim is less than or equal to 8 mm in height.
In another preferred embodiment, the inner rim surface is shaped to facilitate stable contact with an opposing inner rim surface when pressure is applied laterally to compress the rim. In a more preferred embodiment, a pressure of between about 300 and 1000 grams compressive-force is required to be applied to the opposing outer rim surfaces to form a stable contact with the opposing inner rim surfaces. In another preferred embodiment, the outer rim surface comprises at least one groove that reduces the tendency of the compressed device to slip betw
Cone Richard A.
Moench Thomas R.
Whaley Kevin J.
Bell Boyd & Lloyd LLC
Brown Michael A.
The Johns Hopkins University & ReProtect, LLC
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