AU640902B2 - Female condom - Google Patents

Description

OPI DATE 29/11/90 AOJP DATE 10/01/91 INTERNAl APPLN. ID 35374 89 PCT NUMBER PCT/US89/01784 -REATY (PCT) (51) International Patent Classification 4 (11) International Publication Number: WO 90/13272 A61F 500 Al (43) International Publication Date: 15 November 1990 (15.11.90) (21) International Application Number: PCT/US89/01784 Published With international search report.

(22) International Filing Date: 1 May 1989 (01.05.89) (71) Applicant: M.D. Engineering, Inc. [US/US]; 2536 Barring- 6 4 00 2 ton Court, Hayward, CA 94545 (US).

(72) Inventor: HARVEY, Lash 2309 Byron Street, Palo Alto, CA 94301 (US).

(74) Agents: ZIMMERMAN, Harris et al.; 1330 Broadway, Ste. 1150, Oakland, CA 94612 (US).

(81) Designated States: AT (European patent), AU, BE (European patent), CH (European patent), DE (European patent), DK, FI, FR (European patent), GB (European patent), IT (European patent), JP, KR, LU (European patent), NL (European patent), NO, SE (European patent).

(54) Title: FEMALE CONDOM 31 -28 :38 .37 (57) Abstract A condom (36) designed for use by females includes an oblong tube (28) formed of a pliant, thin material impervious to spermatoza and pathogenic organisms, and including a closed distal end The proximal open end (31) is provided with a semi-rigid retaining ring (32) to maintain the open end from passing into the vagina. The invention includes a lubricated applicator (72) having a soft, broad tip portion (73) received within the closed distal end, and a tubular-handle (74) extending therefrom. The tubular handle (74) may be provided with a telescoping portion which is collapsed in the vending package and extended to facilitate insertion of condom. A thickened, resilient cap portion (37) may be provided at the distal end of the condom to aid retention of the condom after insertion. The sidewall (28) of the condom tube may be provided with one or more pleats (61) extending parallel to the axis of the condom to permit diametrical expansion during intercourse.

See back of page WO090/13272 PC/US89/01784 IFIEWAILIE (CONDON~B Background of the Invention Among the myriad iforms and methods of contraception, the oldest and most prosaic device, the condom, has recently become the subject of intense medical and commercial interest. The complications associated with intrauterine devices and birth control pills have mitigated against their use in most cases. Moreover, the appearance of the HIV virus and the impending Acquired Immune Deficiency Syndrome epidemic have created an atmosphere of caution and prudence in which sexually active adults must consider protecting themselves from infection by HIV virus and other venereal diseases. It is generally accepted as fact that the condom provides the best protection from venereal disease and HIV virus, aside from complete sexual abstinence.

Condoms as known in the prior art are known to suffer some drawbacks, chiefly in that they interfere with the normal progression of intercourse. Use of the condom requires male arousal first, followed by an interruption to open a condom package and apply the condom to the male member. Moreover, condoms are usually packaged in a lubricating fluid, and are often cold to the touch. This application of a cold object to the male member is aversive to many individuals, and discouraging to its use.

Furthermore, the membrane of the condom, no matter how pliant or thin, WO 90/13272 PCT/US8910178LZ 2 is often viewed as a barrier to the most intimate tactile sensations of intercourse.

From a commercial standpoint, surveys have shown that nearly of condoms purchased are sold to women, although it is clear that condoms as known in the prior art must be worn by the male. Therefore there is an implication that many women are concerned about contraception and disease prevention, and desirous of taking steps toward prevention of both.

However, there is no device known in the prior art that prevents conception and disease, and can be used solely by the female prior to intercourse.

3 Summary of the Present Invention There is disclosed herein a female condom, comprising a hollow tubular member formed of a thin, plient, web material having a continuous, curved sidewall disposed about a longitudinal axis and including proximal and distal ends, said distal end having an end closure formed integrally with said sidewall, said proximal end being open, and removable means for inserting said tubular member into the vagina with said distal, closed end extending innermost and said proximal, open end extending outward of the vagina; r fr

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4 ,i .F/02491 4 means at said distal end of said hollow tubular member for increasing the retention of said condom within the vagina, including a cap integrally formed at said distal end closure, said cap having a diameter greater than the diameter of said hollow tubular member; and a plurality of collapsible fingers extending proximally from said cap and joined to said hollow tubular member and spaced circumferentially thereabout, said fingers being adapted to collapse together in compression during insertion of said condom in the vagina and to expand resiliently against the vaginal wall to anchor said condom therein.

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f1 Le S LF/02491 Brief Description of the Drawings A preferred form of the present invention will now be described by way of example with reference to Figs. 2, 4, 8, 9, 10, 11 and 12 of the accompanying drawings, the embodiments depicted in Figs. 1, 3, 5, 6, 7, 13 and 14 being presented for information only.

In the drawings: Figure 1 is an exploded view of a female condom and applicator.

Figure 2 is a schematic end view of a female condom Inserted in place.

Figure 3 Is a perspective view of a simplified form of the female condom, shown with the tubular application Inserted therein.

Figure 4 is a perspective view of an embodiment of the female condom in accordance with the present invention, including an expandable proximal end cap.

Figure 5 is a partially cutaway perspective view of a further embodiment of the female condom, including an expandable sidewall having a resilient convex shape to aid in retention of the condom after insertion.

Figure 6 is a perspective view of a further embodiment of the female condom, including an expandable sidewall having a compliant gel lining.

i /02491 WO 90/13272 PCr/US89/01784 6 Figure 7 is a perspective view of a further embodiment of the female condom, including a constricted proximal portion adapted to capture the male member after initiation of intercourse.

Figure 8 is an end view of a further embodiment of the female condom, showing an adhesive seal for closing the proximal end of the condom after use.

Figure 9 is an enlarged fragmentary cross-sectional view of the 1 0 adhesive seal shown in Figure 8.

Figure 10 is a cross-sectional end view of a further embodiment of the female condom, including a longitudinally extending pleat for diametrical expansion.

Figure 11 is a cross-sectional end view as in Figure 10, showing the longitudinal pleat in an expanded disposition.

Figure 12 is a cross-sectional end view of a further embodiment of the female condom, including a plurality of longitudinally extending pleats for diametrical expansion.

Figure 13 is a perspective view of a further embodiment of the female condom, including a thickened distal end cap portion.

WO 90/13272 PC/US89/01784 7 Figure 14 is a perspective view of a further embodiment of the female condom, showing a spring-type diaphragm incorporated into the distal end of the condom.

Figures 15a and 15b are a sequence of enlarged, cross-sectional views of the retaining ring portion of the female condom, showing the unrolling of the condom from the retaining ring.

1 0 Figure 16 is a perspective view of a preferred form of packaging for the female condom -f the p ent inenti. including the condom and an applicator received within a cup-like receptacle.

Figure 17 is a top view of the package shown in Figure 16.

Figure 18 is a schematic view of the female condom and applicator, depicting the unrolling extension of the condom and the telescoping extension of the applicator.

Figure 19 is an enlarged, cross-sectional view of the telescoping applicator f thprent ivenion.

WO 90/13272 PCT/US89/01 784 Figures 20a and 20b are a sequence of enlarged, cross-sectional views taken along line 20-20 of Figure 19 and depicting the locking extension of the telescoping applicator handle.

WO 90/13272 PCT/US89/01784 Description of the Preferred Embodiment The present invention generally comprises a condom for use in preventing both contraception and transmission of venereal diseases. A salient feature of the invention is that it is designed to be used by a female prior to intercourse, rather than by the male, as is known in the prior art.

With regard to Figure 3, the basic configuration of the present invention includes a a condom 21 formed of a generally cylindrical tube 22. The tube 22 includes a distal end 23 having an integrally formed closure of 1 0 generally hemispherical or smoothly rounded configuration, and a proximal end 24 that is open. A generally form-retaining applicator 26 is received within the condom 21 only for purposes of insertion of the condom into the vagina of the female. The applicator 26 in this embodiment comprises a solid rod or hollow tubular rod of polymer or plastic material having sufficient rigidity to be urged into the vaginal opening. The interior of the condom is provided with a lubricant to release the applicator rod and permit its withdrawal therefrom after insertion of the condom. The condom forms a closed lining of the vagina, with the proximal end of the condom extending outwardly of the vagina, to prevent epidermal genital contact during intercourse, and to prevent the release of semen within the vagina.

A salient feature of the female condom of the present invention is that it is a positive step that a woman may take prior to intercourse to assure contraception and prevent disease transmission, without requiring WO 90/13272 PCP/US89/01784 the participation or acquiescence of the male partner. Due to the fact that the female condom may be inserted long prior to intercourse, it does not necessarily comprise any interruption or interference with sexual intercourse.

A further embodiment 30 of the female condom, shown in Figure 1, includes a generally cylindrical tube 28 having a closed, smoothly curved distal end 29. The proximal end portion 31 includes a bell-shaped portion flaring outwardly toward the proximal end and joined thereto to a semirigid, resilient retaining ring 32. The bell-shaped portion is larger in 1 0 diameter than both the medial tube portion 28 and larger than the nominal vaginal opening. As the applicator 26 is used to insert the condom in the vagina, the bell-shaped portion 31 remains external to the vagina, forming a barrier between the male penis and the vaginal wall as well as the adjacent peroneal and vulvar areas 33, as depicted in Figure 2. The extended barrier created by the portion 31 is particularly useful in preventing disease transmission. It should be noted that the ring 32 prevents collapse of the bell-shaped portion 31 and to maintain its protection.

Another embodiment 36 of the female condom, depicted in Figure 4, includes the tubular portion 28, flared, bell-shaped portion 31, and retaining ring 32 described previously. It further includes a distal end having a thickened hemispherical portion 37 extending about the closed distal end. The portion 37 includes a plurality of fingers extending distally and spaced peripherally about the proximal end of the portion 28. The WO 90/13272 ]PCVUS $9/0q17847 A11 portion 37 and fingers 38 may be formed of a resilient, biologically compatible material, such as latex rubber or a synthetic equivalent. During insertion of the condom through the relatively narrow vaginal opening, the fingers 38 resiliently compress radially inwardly toward the axis of the tubular portion 28, thereby diminishing in diameter for purposes of insertion, After complete insertion of the portion 28 into the vagina, the fingers resiliently expand and reassert their original diameter. The increase in diameter retains the condom in place in the vagina, during and after intercourse. However, the condom can be removed by manually grasping the ring 32 and adjacent bell-shaped portion 31 and pulling the device from the vagina, the fingers 38 collapsing together during withdrawal.

With regard to Figure 5, a further embodiment of the invention includes a female condcm: 41 having an outwardly flared, bell-shaped proximal portion 31 and retaining ring 32 as described previously. The tubular portion 43 of the condom is formed of a resilient membrane material having elastic memory, the portion 43 having a quiescent sidewall configuration of an prolate, elongated, closed curved structure having a rounded, blunt distal end 44 and a proximal end joined to the bell-shaped portion 31 by a diametrical constriction portion 42. It may be appreciated that during insertion of the condom by an applicator 26 or the like, the tensile force applied axially to the condom by the applicator causes the condom to elongate elastically and constrict diametrically. When the applicator is withdrawn, the elastic memory causes the portion 43 to WO 90/13272 PCr/US89/01784 12 reassert its quiescent, prolate form with the constricted diameter returning to normal and expanding against the vaginal wall to retain the condom within the vagina.

A further modification of the device of Figure 5, shown in Figure 6, comprises a female condom 48 having the same external configuration and components 31, 32, 42, 43, and 44 as the previous embodiment. The device 48 further includes an inner wall 46 having a generally cylindrical configuration, and a deformable gel layer 47 disposed between the two concentric walls 46 and 43. The shape of the device 48 creates a retaining effect within the vagina, as explained above in Figure 5. Furthermore, after initiation of intercourse the insertion of the penis within the sidewall 46 causes some of the gel 47 to flow toward the proximal end of the device, creating a "plug" effect that further retains the female condom and prevents its accidental removal during intercourse.

1 5 The embodiment of the female condom shown in Figure 7, unlike all the previous embodiments, is designed to be dislodged from the vagina by the penis during intercourse and to be subsequently retained on the pei,~.

similarly to a typical prior art male condom. It includes the retaining rilg 32 and flared portion 31, as well as a narrow contriction 50 smaller in diameter than the constrictions 42 of the embodiments of Figures 5 and 6.

Extending distally from the constriction 50 is an axially extending, cylindrical tubular membrane 52 having a closed, curved distal end 53.

The condom 51 is easily inserted in the vagina using an applicator 26 or the like, the flared portion 31 protecting the outer genital area. After WO 90/13272 P~rUS89/01794 13 initiation of intercourse, the constriction 50 expands elastically to admit the penis, and thereafter contracts about the base of the penis and is retained thereat. The condom 51 is thereafter secured to the penis, and moves in concert therewith. Seminal fluid released within the condom is retained therein after completion of intercourse.

For those embodiments that are retained within the vagina during and after intercourse, the embodiment of Figures 8 and 9 is intended to seal the female condom after use and retain whatever fluids remain within it. A layer 56 of contact adhesive is applied to the inner peripheral surface 1 0 of the retaining ring 32 of any of the embodiments described herein, and a peelable protective strip 57 is then applied to the adhesive. When intercourse is concluded, the strip 57 is peeled off, exposing the adhesive layer. The opposed portions of the ring 32 are then pressed together, sealing the proximal opening and preventing spillage of fluids within the condom during removal thereof. Alternately, after intercourse the proximal end may be either twisted or tied and knotted to seal the condom prior to removal.

A further modification of the present invention, shown in Figures 10-12, is directed toward enhancing the diametrical expansion of the female condom to prevent the condom from coupling to the male member and being pulled out of the vagina during intercourse. The generally cylindrical tubular portion 28 of the condom, as described previously, is provided with -one pleat 61 (Figure 10) or a plurality of pleats 61 (Figure 12) extending longitudinally therealong. Each pleat comprises a pair of WO 90/13272 PMCTUS89/01784 14 fold lines 62 extending longitudinally in mutual opposition, with a pair of flaps of overlapping condom sidewall extending from each respective fold line, as best shown in Figure 10. The sidewall portions involved in the pleat determine a diameter D of the condom, 'the diameter D being sufficiently small to facilitate insertion of the condom. After initiation of intercourse, if the diameter of the penis is greater than diameter D, the pleat (or plea.) will unfold, as shown in Figure 11, to a dimension D+X, sufficient to accommodate the larger penis and assure that the condom will not engage and be retained on the penis. Thus the condom will remain in the vagina, to be removed manually after intercourse.

Another embodiment of the present invention, shown in Figure 13, includes th tubular portion 28 and the flared portion 31 and retaining ring 32 described previously. The distal end of the portion 28 is closed by an expandable cap 64 that is formed with a wall thickness greater than the 1 5 relatively thin wall of the tubular portion 28. The increased diameter and form-retaining nature of the thickened end portion 64 acts to anchor the condom in the vagina and prevent accidental withdrawal, and is easier to manufacture than the embodiment of Figure 4, for example.

With regard to Figure 14, a further embodiment of the present invention comprises a female condom having a proximal retaining ring 32 and a large diameter cylindrical proximal portion 66 designed to provide exterior protection from epidermnal contact. The proximal portion 66 is joined to a medial cylindrical portion 67 of reduced diameter. At the distal end of the device, an arcing spring diaphragm 68 (known in the prior art WO 90/13272 PCT/US89/01794a for contraceptive purposes) is joined to the distal end of the portion 67.

The diaphragm anchors the device within the vagina, the portion 67 lining the vaginal wall to prevent trz.nsmission of disease or passage of spermatozoa.

A significant aspect of the retaining ring 32 portion of several of the embodiments described above is that the ring 32 forms a base upon which the condom portion 31 or 66 may be rolled to reduce the length of the condom for purposes of packaging, as shown in Figure 15b. Also, it may be appreciated that the condom can be unrolled from the retaining ring 32 1 0 to a length sufficient for the anatomy of the user (Figure 15a), so that one size female condom may accommodate most users. Furthermore, the rolled up portion remaining external to the vagina is unnoticable, and the ability to take up surplus length at the exterior avoids awkward amounts of condom material in the female genital region.

1 5 With regard to Figures 16 and 17, one form of package suitable for the female condom comprises a cup-like receptacle 68 formed by vacuum forming or molding of impervious plastic material. A flange 69 extends from the upper edge of the receptacle 68, and a peelable, sealed top 70 is secured to the flange 69 to hermetically seal the receptacle and the condom 71 stored within. The condom 71 is rolled at its proximal end about the retaining ring 32 to foreshorten the condom and permit its fitting into the receptacle. In addition, an applicator 72 is received concentrically within the receptacle and within the distal end of the condom in the package.. The applicator includes a broad distal tip 73 formed of expanded foam material WO 90/13272 PCr/US89/0178 .16 or the like and impregnated with a lubricant, such as polydimethylsiloxane or the equivalent. Joined to the tip 73 and extending coaxially and distally therefrom is a telescoping handle 74. The handle comprises a plurality of tubular, nesting sections that are collapsed into a concentric configuration in the package 68.

As shown in Figure 20a, each section 74a of the handle 74 includes a flange 76 extending radially at the distal end thereof, and an annular flange 77 spaced apart from the flange 76 to define an annular gap therebetween.

The flange 77 includes a ramped distal surface. Each section 74b includes at its proximal end a flange 78 extending radially inwardly from the interior bore surface thereof and provided with a ramped surface 81.

When the section 74b is pulled distally, as shown in Figure 20b, the surface 81 of the flange 78 rides over the surface 79 of the flange 77 in snap action, the flange 78 being retained thereafter in the annular gap between the flanges 76 and 77. Thus mere manual tension applied to the distal end of the applicator 74 in the opened package 68 causes the handle to telescope outwardly from the package and form a rigid, elongated tubular assembly.

Thereafter the female condom may be removed from the package, and the retaining ring may be unrolled to define a suitable length for the female condom, as shown in Figure 18. The condom 71 is then inserted in the vagina, using the extended applicator, and the applicator is removed and discarded. It may be appreciated that the lubricant incorporated in the tip 73 remains within the condom to ease the passage of the penis therein.

Furthermore, the insertion of the condom in the vagina prior to WO 90/13272 PCT/S89/01784 17 intercourse warms the condom to body temperature prior to coitus, so that the chilling effect of prior art male condoms is avoided.

It may be appreciated that there are various features described in the many embodiments of the present invention. It is within the scope of the invention to combine these features in various configurations as required, without departing from the intent or overall purpose of the invention.

It should be noted that the present invention has been described with regard to heterosexual intercourse; it may be appreciated that it can be used equally effectively in homosexual intercourse to prevent disease transmission.

Claims (1)

1. 2. The female condom of claim 1, wherein said cap is provided with a wall thickness greater than the thickness of said sidewall of said hollow tubular member. DATED this ELEVENTH day of JUNE 1993 Engineering, Inc. C Patent Attorneys for the Applicant SPRUSON FERGUSON RLF/02491