BACKGROUND OF TBE IHVBNTION

The invention concerns contraception and the prevention of sexually-transmitted diseases by means of a barrier-type device and further concerns a barrier-type device which engages the cervix by extending into the forniceε and seals circumf erentially against the vagina in the vicinity of the cervix. The prior art devices for- intr avaginal , barrier-type prevention of conception and sexuaJly transmitted disease include the diaphragm and the cervical cap. The diaphragm, when seated intr avaginally, acts as a barrier to prevent sperm from entering the os of the cervix. A spermicide is used on the inside of the diaphragm to kill sperm traversing over the edge of the diaphragm. Characteristicall , the diaphragm is a shallow rubber cup with a rin. & round, coiled metal spring is disposed in the rim. The diaphragm iε intended for intravaginal disposition between the posterior aspect of the pubic bone and the posterior for nix.

When thus seated, the diaphragm presses against the vaginaJ wall to form a continuous barrier therewith.

The cervical cap iε a small, vaulted or domed device, more rigid than the diaphragm, and dimensioned to fit over a cervix, where it is retained by suction, rather than spring tension as is the diaphragm. The cap includes a dome which rises from a rim. The cap is slipped over the cervical protrusion to block access to the uterus through the cervical os.

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None of these barrier-type devices is adapted to fit in close anatomical sealing engagement between the vagina and the cervix. The diaphragm is held against the upper part of the vaginal canal by the tension of the spring in its rim, while the cervical cap typically engages only the tip of the cervix. Both of these devices can be dislodged by sexual arousal, coital activity, or orgasm. As is known, such dislodgment can reduce the effectiveness of the barrier and permit unintended ertilization or unwanted infection, or worse, both.

In failing to take into account the anatomy and physiology of the vagina and the cervix, the prior art barrier-type devices form imperfect barriers against the penetration of sperm and agents of sexually transmitted diseases into the uterus. As is known, fertilization and infection take place within the uterus, therefore the more sound the barrier to the cervical os, the greater the likelihood of preventing such fertilization or infection. With the emergence of the AIDS (acquired immune deficiency syndrome) epidemic, the risk of life-threatening infection accompanying heterosexual activity iε increasing steadily. Therefore, there iε a compelling need for intravaginal, barrier-type devices which can substantially decrease - the risk of infection by significantly increasing the effectiveness and reliability of the barrier to entry of bodily fluids such as semen, into the cervix.

Accordingly, it iε an urgent objective of the invention to provide an intravaginal, barrier-type device which accounts for, and takes advantage of, the anatomy and physiology of the vagina in the vicinity of the cervix to

form a more perfect, and a more reliable, seal against the movement of sperm and micro organisms from the vaginal canal through the cervical os into the uterus.

A significant advantage of such a device is the simultaneous reduction of the prospects of conception.

SUMMARY OF TBE IRVBNTION

The invention is based upon the inventor's critical observation that a barrier-type device engaging the cervix and the vagina by seating at the bottom of the fornices and then folding back from the fornices along the interior vaginal walls provides a barrier adapted to the anatomy and physiology of the vagina in the vicinity of the cervix which not only forms a reliable, effective seal, but also resists displacement during arousal, intercourse, and orgasm. The device conforms to and sealingly engages the vagina in the vicinity of the cervix. The sealing engagement of the device with the vagina iε continuous during all of the expected physiological changes which the vagina and cervix undergo as the result of, for example, sexual activity and menstrual cycle.

From its structural aspect, the invention iε a barrier- type device for preventing conception and infection by sexually transmitted diseases, which includes a cervical dome fabricated from a flexible, physiologically non- reactive material, which has an opening and a curved surface extending from the opening to a dome peak. The dome transitions to a continuous fornical rim, the rim defining the opening of the dome. The rim transitions through a backward fold against the dome to a continuous, annular, vaginal brim circumscribing the dome.

Preferably, the vaginal brim has a dimension which continuously increases with circumferential symmetry from an anterior vaginal extension to a posterior vaginal extension diametrically opposite the anterior vaginal location. The device further includes an inwardly-turned, annular lip on the rim which juts into the opening. The lip, rim, and dome form an annular trapping groove between the brim and the dome.

From another aspect, the invention is a method of preventing conception and infection by sexually transmitted diseases with a barrier-type device having a cervical dome which transitions to a fornical rim defining an opening in the dome, the rim transitioning by a backward fold to a vaginal brim circumscribing the dome and extending from the rim toward the top of the dome. The method includes steps of applying a sper icide to the device and placing the device in an intravaginal, blocking position which situates the dome in a cervical blocking position, and in which the rim iε fornically engaged and the brim is in a continuous, sealing vaginal engagement.

In the method, the vaginal brim has a dimension which continuously increases with circumferential symmetry from an anterior vaginal location on the brim to a posterior vaginal location on the brim diametrically opposite the anterior vaginal location, the method further including the step of orienting the device to place the anterior vaginal location in an anterior vaginal engagement and the posterior vaginal location in a posterior vaginal engagement.

The invention iε also found in the combination of an intravaginal , barrier-type device for preventing conception

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and infection by sexually-transmitted diseases including a device, fabricated from a flexible physiologically non- reactive material, and having a cervical dome with an opening defined by a rim and a curved surface extending to a dome peak and further including, transitioning by a backward fold from the rim, a continuous, annular vaginal brim circumscribing, and attached to, the cervical dome at the rim, and having a dimension which continuously increases with circumferential symmetry from an anterior vaginal location on the brim to a posterior vaginal location on the brim. An applicator for placing the device in operational disposition includes a speculum-type lower body with a main member that transitions to an angled member with an edge for engaging the barrier-type device between the brim and the dome at the posterior fornical location. The insertion device further includes a mechanism, slidably disposed in the main member for releasably engaging the vaginal brim at the anterior vaginal location.

One will appreciate how the summarized invention achieves the above-stated objectives when the detailed description iε read with reference to the below-described drawings, in which:

Figure 1 illustrates a perspective view of the barrier- type device of the invention; Figure 2 is a plan view of the device;

Figure 3 iε a sectional view of the device taken along lines 3-3 of Figure 2;

Figure 4 iε a sectional view, rotated 90 ^c from Figure , and taken along lines 4-4 of Figure 3;

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Figure 5 iε a partial, sagittal εection of female sexual anatomy showing, in schematic representation, the posterior aspect of the vaginal tract and the barrier-type device in place covering the cervix, and sealing to the posterior of the vaginal canal;

Figure 6 illustrates a schematic of the posterior of the vaginal canal from a frontal aspect showing the barrier- type device in place;

Figure 7-10 illustrate the structure and operation of the applicator for insertion of the barrier-type device of Figures 1-6 into the vagina; and

Figures 11 and 12 illustrate an extractor for removal of the barrier-type device from intravaginal placement.

DBTAI ED DBSCRIPTIOH OF TBB PREFBRRBD BKBODIMB8T An intravaginal, barrier-type device for preventing conception and infection by sexually -transmitted diseases iε illuεtrated εtructurally in Figures 1-4. Preferably, the device is a single piece formed by molding a flexible, physiologically non-reactive material, such aε latex rubber. The device 8 includes a cervical dome 10. The dome preferably haε a hemi-spherical or hemi-ovoid shape which forms a cervical enclosure. At the opening of the enclosure, the dome 10 transitions to a fornical rim 12, which in turn, transitions by a backward fold to a vaginal brim 14. As best seen in Figures 3 and 4, the dome has a peak, or top, 16.

As Figures 1-4 reveal, the vaginal brim circumsc ibes, or surrounds, the dome and extends upwardly from the rim 12.

The brim exhibits lateral symmetry, as illustrated in Figure 3, where the lateral extensions 14a and 1 b of the brim 14

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are substantially equal in form and dimension. The width of the brim increases continuously from the anterior to the posterior of the device 8. This increase is revealed in Figures 1 and 4. In Figure 4, the anterior extension 14c of the brim 14 has a smaller dimension 22 than the dimension 23 at the posterior extension 14d of the brim 14. The brim also has an outward bias, or curve, to it, as is seen in Figures 1, 3, and 4.

The width of the brim increases with circumferential symmetry from an anterior vaginal location 18 on the anterior extension 14c of the brim to a posterior vaginal location 20 on the posterior portion 14d of the brim. The circumferential symmetry of the brim 14 is illustrated in Figure 2. In Figure 2, point A over the lateral extension 14a is displaced in a counterclockwise direction on the rim 12 from the anterior vaginal location by a rim segment equal to the rim segment by which the point B over the lateral extension 14b is displaced on the rim 12 clockwise from the anterior vaginal location 18. As shown in Figure 3, the dimension 26 reflecting the width of the brim at extension 14a is equal to the dimension 28 reflecting the width of the brim at extension 14b.

An annular lip 2 iε formed in the device 8 by an inward extension of the rim 12 along the periphery of the opening into the dome 10. The lip 24 juts into the opening toward the center line 25 of the dome 10. The backward fold of the rim 12 at the lip 24 by which the rim 12 transitions to the brim 14 forms an annular groove 27 between the brim 14 and dome 10.

The significance of the structure of the barrier-type device 8 is illustrated in Figures 5 and 6. In Figures 5 and 6, female anatomy is conventionally illustrated as including a cervix 30 through which the cervical os 32 opens to the interior of the uterus 34. The vagina 36 includes an inner surface 37 which transitions to the cervix 30 by way of a fornix, an anatomical fold or recess. As is known, the fornix increases in depth from its anterior to its posterior aspects, which are usually referred to as the anterior fornix 38 and the posterior fornix 39, respectively _* Further, at its rear, the vagina 36 transitions, by way of the anterior vaginal wall 40 to the anterior fornix 38, and by way of the posterior vaginal wall 42 to the posterior fornix 39. As shown in the frontal cross section of Figure 6, the fornix is laterally symmetrical.

Figures 5 and 6 illustrate how the barrier-type device of Figures 1-4 is adapted to the anatomy and physiology of the vagina in the vicinity of the cervix. As εhown in Figure 5, the proper orientation of the device 8 finds the cervical dome 10 engaging the cervix, which extendε through the opening defined by the rim 12. The rim iε seated at the bottom of the forniceε. The annular lip 24 grips the bottom of the cervix at the fornices, thereby forming a circumferential seal. The brim 14 extendε from the bottom of the forniceε in close sealing engagement with the walls of the vagina, thereby continuing the circumferential seal along the vagina forwardly from the forniceε. The barrier- type device is oriented with respect to the cervix to place the anterior extension 14c against the anterior vaginal wall 40, in the vicinity of the anterior fornix. Similarly,

the posterior extension 14d is oriented to engage the posterior vaginal wall 42 in the vicinity of the posterior fornix. As shown in Figure 6, the orientation of Figure 5 disposes the lateral rim extensions 14a and 14b against the lateral vaginal walls in the vicinity of the lateral forniceε.

As shown in Figures 5 and 6, not only does the device seal to the vagina and cervix, it orients the annular groove

27 toward the opening of the vagina. Thus oriented, the groove 27 will trap fluids traveling along the inside of the brim 14 toward the dome 10.

In use, a spermicide such as NONOXYNOL-9, is applied to the total surface of the device 8, and the device is inserted into the vagina to engage the cervix with the orientation illuεtrated in Figures 5 and 6. Thuε, seated, the barrier-type device of the invention will seal from the base of the cervix, in the fornices and continuously and circu ferentially along the vagina. This seal is superior to the prior art barrier devices. As iε known, the diaphragm would engage only the posterior fornix, extending across the top of the vaginal wall forward of the anterior of the cervix. The cervical cap engages only the top of the cervix, and, generally, does not extend fully into the posterior, anterior, and lateral fornices. Bowever, the device 8 fits precisely to the anatomy and physiology of the vagina in the vicinity of the cervix. Such an ananatomically adapted form will not only seal effectively when the device iε εeated, but will also seal reliably by resisting unintentional displacement or dislodgment. The device iε retained in place by suction exerted in the

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cervix by the dome 10, by the grip exerted on the base of the cervix by the annular lip 24, by a snug fitting between the rim 12 of the fornices, and by the outward curve of the brim, which flattens against the vagina. All of these mechanisms help prevent dislodgment of the device and contribute to the seal which the device makeε.

An applicator for intravaginal placement of the barrier-type device 8 iε illustrated in Figures 7-10. The applicator 50 consists of a speculum-type portion with a main body, or a handle, 52 which transitionε into a projection 54 having an angle of, preferably, 40 with the main body 52. As seen in Figure 7, the angled projection 54 has a concave recess 55. A rounded forward edge 56 iε provided on the distal end of the projection 54. A movable inserter 57 iε slidably disposed in the main portion 52 and moved in the main portion between a first position, indicated by the solid lines in Figure 7, and a second, release, position denoted in Figure 7 by the interrupted lines. The inserter 57 consists of two equivalent elongate pieces 57a and 57b having serrated forward faces 60a and 60b and rear flanges 61a and 61b, respectively. The applicator 50 is formed from a physiologically inert material, such as a relatively rigid plastic, and has all of its edges and ends smoothed and rounded to reduce the prospect of injuring the vagina during placement of the device 8.

Figures 8-10 illustrate how the applicator iε used to place the barrier-type device 8. As shown in Figure 8, the barrier-type device is carried on the applicator by engagement of the forward end 56 in the groove 27 of the device 8 formed between the dome 10, the rim 12, and the

posterior vaginal extension 14d. The brim 14 is grasped between the serrated surfaces 60a and 60b at the anterior vaginal extension 14c. The inserter 57 iε retracted to the first position. In this position, the serrated faces 60a and 60b are forced together with the anterior vaginal extension 14c grasped between them. As the inserter 57 iε drawn backward to the first position, the barrier-type device iε stretched and retained on the applicator 50 by the tension of the flexible material from which the device 8 iε formed. Thus arranged, the barrier-type device on the applicator 50 iε placed intravaginall , with the device oriented as in Figure 5.

After traversing the vaginal canal, the end 56 of the applicator 50 will place the posterior vaginal extension 14d of the brim against the posterior vaginal wall and seat the rim 12 in the posterior fornix 39. When this occurs, the anterior vaginal extension 14c will still be forward of the anterior fornix 38. Next, the inserter 57 iε slid forwardly in the main body 52 to the second position, which will move the anterior vaginal extension 14c into engagement with the anterior fornix 38. When this occurs, the barrier-type device 8 will be retained in the engagement of Figure 5 by the mechanisms described above.

Removal of the applicator can be understood with reference to Figures 9 and 10. When the barrier-type device iε seated by forward movement of the inserter 57, the flexibility of the members 57a and 57b will cause the serrated faces 60a and 60b to spring apart slightly. Next, with the barrier-type device retained in position by εuction, the upper member 57b iε moved rearwardly toward the

first position, which disengages the inserter from the anterior vaginal extension 14c of the brim. The lower member 57a is then pulled rearwardly. This completely disengages the applicator 52 from the anterior fornical extension 14c of the brim, and permits the applicator 52 to be removed.

As shown in Figures 11 and 12, an extractor 64 has an: elongate portion 66 with a cross section substantiall flattened in a plane. The distal tip of the elongate portion. 66 transitionε to a hook- 68. The hook curveε backwardly over the elongate portion and iε flattened in the same plane. An operating handle 69 iε attached to the proximal end of the portion 66, to be substantially perpendicular to the plane of flattening of the portion and hooks.

The barrier-type device 8 iε extracted by insertion of the elongate portion 66, hook first, flat into the vagina in the direction of the anterior fornix. When the anterior fornix is encountered, the extractor iε rotated 90, by the handle, to bring the hook 68 into engagement with the back of the brim 12 at the anterior vaginal location. The extractor iε pulled out, bringing the device 8 with it.

Obviously, many modifications and variations of the present invention are possible in light of the above teachingε, and it iε therefore understood that within the scope of the disclosed inventive concept, the invention may be practiced other than aε specifically described.