2. Discussion of the Related Art Devices which are intended to be inserted into the vagina are known for use as contraceptive barries. One particular contraceptive device, the cervical cap, is placed over the cervix to prevent semen from entering the cervical canal and is held in place according to a suction grip by precise fit or by a form-assuming dome using the surface viscosity of a moist cervical surface.

United States Patent No. 4,785,804, for example, provides a disposable cervical cap having a thin, form-assuming, flexible dome portion that allows for its use with a majority of the female population regardless of the size of the female's anatomy. There exists, however, a small percentage of the female population who are precluded from using a cervical cap because of the shape or angle of the cervix or prolapse of the uterus, for example.

The present invention provides an improved disposable cervical cap which overcomes the aforementioned problems. Due to its novel construction, the cervical cap of the present invention allows for its use by women with unique physical characteristics or variations in anatomy, while inhibiting the transmission of sexual disease through cervical tissue.

Summary of the Invention The present invention provides an improved disposable cervical cap having a thin-walled, flexible, and pliant dome with an integrally-molded flexible annular rim. In position, the flexible, form-assuming dome of the cervical cap conforms to the exocervical surface to closely fit the surface upon contact.

Due to its thinness and applicability, the dome of the cap will continue to

adhere to the surface of the cervix until removed. Adherence of the dome to the cervix is further facilitated by the moist cervical surface.

The improved cervical cap of the present invention further includes a thin, form-assuming substantially frustoconical flange or skirt that has an inner and outer surface and extends from the annular rim opposite the dome. The form-assuming flange aids in allowing women with unique anatomy characteristics, as for example, an elongated cervix, to utilize a cervical cap for contraception, while preventing the transfer of diseases by sufficiently covering the cervix tissue.

Additional advantages and features of the present invention will become apparent from the subsequent description in the appended claims taken in conjunction with accompanying drawings.

Brief Description of the Drawings FIG. 1 is a side view of a preferred embodiment of a cervical cap of the present invention; FIG. 2 is a top elevational view of the cervical cap; FIG. 3 is a sectional view, taken along line 3-3 in FIG. 2; FIG. 4 is a side view of an alternate preferred embodiment cervical cap of the present invention; FIG. 5 is a sectional view, taken along line 5-5 in FIG. 4.

Detailed Description of the Preferred Embodiment Referring to FIG. 1, a preferred embodiment of a cervical cap with a thin, form-assuming substantially frusto-conical flange of the present invention is illustrated and indicated generally by the numeral 10.

Generally speaking, cervical cap 10 comprises a flexible, thin, form- assuming dome 12, an apex portion 14, a base portion 16, and an annular rim 18. Dome 12 is generally thimble-shaped, with base portion 16 inwardly tapering toward apex portion 14. The outer diameter of rim 18 is greater than that of base portion 16 of dome 12.

Cervical cap 10 further includes a thin, form-assuming substantially frustoconical flange or skirt 20. Referring to FIG. 3, flange 20 includes an inner surface 22 and an outer surface 24. Flange 20 additionally extends downwardly from the rim of the cap, opposite that of the dome, and is slightly flared.

The use of a disposable cervical cap with flange 20 provides additional stretchabiiity for the elastomeric material of the cap, allowing use of the cap by women having variations in their anatomy, such as an unusual shape or angle of the cervix or prolapse of the uterus. Additionally, not only does the flange improve the efficacy of the cervical cap as a contraception device, the flange aids in the prevention of sexually transmitted diseases to women who may have, for example, an elongated cervix by protecting cervical tissue from contact. Diseases of this nature are most easily transmitted by way of contact of the cervical tissue. Thus, because of the construction of the flange, cervical cap 10 may be used by the population of women with unique physical and anatomical characteristics.

The cervical cap of the present invention may also be employed as a conception device, depending on the desired result. While the use of the cervical cap as a contraception device functions to prevent semen from entering the cervical canal (Os), the conception device aids in fertilization when sperm is placed inside the cap and the device is placed over the cervix, thereby concentrating sperm at the opening of the Os.

In an additional preferred embodiment, referring particularly to FIGS. 2 and 3, annular rim 18 has an inner surface 28 and an outer surface 30. Thin, gripping finger 32 projects upwardly and outwardly, as finger 32 is integrally- formed with inner surface 28. Finger 32 also defines an upper portion of a notched indentation 34 as viewed in FIG. 3. Annular rim 18 contains at least two gripping fingers 32 that are directly opposite or symmetrically opposed from each other along inner surface 28. However, it will be appreciated to one skilled in the art that more than two fingers could be employed.

Fingers 32 effectively grip and hold cervical cap 10 over the cervix in order to prevent semen from entering the cervical canal. Gripping fingers 32

and notched indentation 34 essentially provide the effect of a Chinese finger puzzle by gripping the side walls of the cervix and holding the cap when the circumference of the rim 18 is fitted around the cervix and slightly expands.

Cervical cap 10 is fixed in place by the use of gripping fingers 32 rather than merely by suction or surface viscosity.

In a further preferred embodiment, cervical cap 10 includes a loop 36 that serves as a handle, facilitates insertion and removal of cap 10, and is integrally-molded with annular rim 18.

Referring now to FIGS. 4 and 5, an alternate embodiment of the present invention provides cervical cap 110 comprising a flexible, thin, form-assuming dome 112, an apex portion 114, a base portion 116, and an annular rim 118.

Dome 112 is generally thimble-shaped, with base portion 116 inwardly tapering toward apex portion 114. The outer diameter of rim 118 is greater than that of base portion 116 of dome 112.

Cervical cap 110 further includes a thin, form-assuming substantially frustoconical flange 140. Referring to FIG. 3, flange 140 includes an inner surface 142 and an outer surface 144. Flange 140 additionally extends downwardly from the rim of the cap, opposite that of the dome, and is slightly flared.

In an alternate preferred embodiment, referring particularly to FIG. 4, a lip portion 148 surrounds outer surface 144 of flange 140. Lip portion 148 aids in inserting the cervical cap into a body cavity by functioning to essentially hold open the flange portion of the cap and further to prevent the flange portion from folding back up into the dome portion of the cap while the cap is being placed over a cervix. The cervical cap as illustrated in FIG. 1 may also include lip portion 148.

Referring now to FIG. 5, rim 118 has an inner surface 120 and an outer surface 122, bottom surface 124, and upper surfaces 126 and 128. Upper surface 126 extends leftward from base portion 116, as viewed in FIG. 5, and terminates at outer shoulder 130. Upper surface 128 extends rightward from base portion 116, as viewed in FIG. 5, and terminates at outer shoulder 132.

Upper surface 128 extends at an acute angle from adjacent base portion 116, preferably, for example, at about an 85 degree angle.

Annular rim 118 has generally inwardly directed annular groove 134.

The side walls or annular groove 134 extend generally toward bottom surface 124 with the opening of annular groove 134 facing inwardly and upwardly as shown in FIG. 5. Adjacent to annular groove 134 are annular upper rim 136 and annular lower rim lip 138. As illustrated in FIG. 5, both upper rim lip 136 and lower rim lip 138 extend generally inwardly and upwardly at an angle acute to dome base portion 116. This lip configuration serves to grip the cervix wall and helps keep the cervical cap in position over the cervix as an alternate embodiment to the configuration shown in FIGS. 2 and 3.

In a further preferred embodiment, cervical cap 110 includes a loop 146 that serves as a handle, facilitates insertion and removal of cap 110, and is integrally-molded with annular rim 118.

It is preferred that the cervical cap of the present invention be constructed of a sperm-impermeable, tear-resistant medical elastomer, such as a silicone rubber, and formed by liquid injection molding. Other suitable materials, such as RTV thermoplastic that can be molded thin enough to be form-conforming and pliant may also be employed.

Preferred materials include a 40 durometer silicone, such as Silastic Q4840 (Dow Corning) or Silicone 4040 (Bayer). When thinly molded, these materials allow for up to a 600% stretch of the molded product. The flange is preferably from about 0.25 to about 0.5 millimeters thick, and more preferably less than about 0.25 thick.

The elastomer material may or may not be impregnated with biologically active components. These components may include, but are not limited to, spermicides, antibiotics, antifungals, and hormonal replacements.

For example, to increase its contraceptive effect, the cervical cap of the present invention may be pre-treated by coating or impregnating its surface with spermicidal agents during manufacture.

The biologically active components may also assist in fertilization, or may be mixed with sperm within the hollow body of the dome of the cap in

order to achieve the desired result. The use of biologically active materials may stimulate sperm motility, prolong the active life of the sperm or aid in gender selection. Selectively eliminating or altering the behavior of some sperm by significantly changing the pH may bias the activity of the X or Y sperm, resulting in odds which favor one particular sex over the other. These components may be released therefrom in an amount effective to achieve its purpose during use.

Although the description as set forth is in conjunction with human subjects, it will be further appreciated that the claimed products may be readily adaptable for use with animal subjects having a cervix.

While it will be apparent that the preferred embodiments disclosed are well calculated to provide the advantages and features above stated, it will be appreciated that the invention is susceptible to modification, variation, and change without departing from the proper scope or fair meaning of the subjoined claims.