CONDOM

Abstract: The device, for use in contraception and in preventing transmission of sexualy transmitted diseases, comprises a thin, flexible pouch (1) having an open end (2) in the form of a peripheral flange with a peripheral ribbed rim (3), and a closed end (4). An insert (17) is provided within the closed end (4) of the pouch so as to protect the pouch during insertion thereof into the vagina by means of an applicator rod (15) or the like. The insert (17), which is typically absorbent and of flexible expanded plastics material, and may have dispersed therein a spermicide and/or an antiviral agent, comprises a central portion (18) and (extending radially outwardly from central portion (18)) four spurs (20a, 20b, 20c, 20d). A continuous coating layer of an adhesive material which can temporarily adhere the barrier device to mucous membrane material in the presence of aqueous body fluids is preferably provided on the vulva-contacting surface of the flange and/or the vagina-contacting surface of the pouch.

Description: _ _ CONDOM Ihe present invention is concerned vith barrier devices icr use in contraception and in preventing transmission of sexually transmitted diseases- It iε knov.n that harrier-type contraceptive devices ("condoms") are effective not only as contraceptives, tut also to help prevent sexual transmission of diseases. Indeed the use of a condom iε positively recommended as a prophylactic measure against, in particular, acquired immune deficiency syndrome (AILS) . Condoms have, traditionally, teen only suitable for use by the male partner; they can only be donned on an erect peniε, immediately before intercourse. hiε haε teen found to be off-putting by many users and the resulting delay can sometimes lead to loss of erection by the male; furthermore, the traditional male condom permits contact tetveen vaginal mucous membranes and the peniε at the entrance to the vagina, v.ith consequent risk of disease transmission. he male condom may become diεlodged under certain circumstances during intercourse (e.g. en loss of erection or ithcraval of the peniε), vith consequent failure of the contraceptive and disease-preventing barrier. In order to alleviate these diεadvantageε and provide an alternative eanε of contraception and prevention of sexual tranεmiεεion of diseases, the so-called "female condom" has teen developed. Cne εuch "female condom" (aε deεcribe in our PC Patent Application GfcL£./GGC42) iε a barrier device SUBSTITUTESHEET which comprises a continuous, liquid-impermeable shield member shaped and dimensioned so that, in its operational position, it covers the entrance of a user's vagina, the εhield member having integral therewith a continuous liquid-impermeable flexible pouch arranged to be introduced into the vagina so as to form a liquid barrier between the penis and the vagina; and eanε for securing the εhield member in the operational position. \ e have now devised an improvement in such barrier deviceε, which can be εuitable for use either as female condoms or as male condoms. According to a first aspect of the present invention, therefore, there iε provided a barrier device compriεing a continuous, liquid-impermeable, flexible pouch having an open end and a closed end such that the pouch can form a liquid barrier between a penis and a vagina; and a soft resilient insert arranged for insertion in said pouch between the tip of the penis and said closed end, said insert compriεing a generally central portion and, extending outwardly from said central portion, meanε for tiassing said pouch in the vicinity of said closed end into contact with the walls of the vagina. According to a second aspect of the present invention, there is provided a barrier device comprising a continuous, liquid-impermeable, flexible pouch having an open end and a closed end such that the pouch can form a liquid barrier between a penis and a vagina; and a soft absorbent resilient insert arranged for insertion in said pouch between the tip of the penis and said closed end, said insert being arranged for biaεεing said pouch in the vicinity of εaid cloεed end into contact with the walls of the vagina. Ihe resilient insert iε such that it facilitates insertion of the pouch into the vagina, either by means of a separate applicator body, by the use of a finger or by means of SUBSTITUTE SHEET the penis. Alternatively, when the pouch iε donned by the male prior to coituε, with the insert located at the tip of the peniε, the insert serveε to maintain the pouch in position during intercourse, and, in some embodiments, after withdrawal of the penis. In addition to fulfilling these functions, the insert enhances tactile pleasure for the uεerε and (when of absorbent material) may asεiεt in abεorption of εperm. Ihe resilient insert iε typically of flexible expanded polymeric material, sponge rubber, solid rubber, plastics or the like; in some embodiments it iε, aε indicated above, absorbent. "Ihe inεert typically comprises a central body portion and a plurality of radially outwardly projectin spurs (such as three or four such spurs) . In some embodiments, the body portion has a central depression for receiving the tip of an applicator rod or the like, and three, four or more outwardly projecting spurs. Ihe body portion may further comprise a formation on its face remote from the latter depression which is arranged to engage with a complementary formation (typically in the form of a teat or the like) provided on the internal surface (that iε, the penis-contacting surface) of the pouch, such that the insert iε retained in position when the pouch iε inεerted in the vagina. Typically, the formation on the body portion compriεeε a protruεicn and the complementary formation on the internal εurface of the pouch comprises a depression capable of receiving the protrusion. Alternatively, the resilient inεert may be retained in position by an adhesive coating on the insert and/or on the internal surface of the pouch. It is preferred in some embodiments of the invention that the inεert should contain a εpermicide and/or a fungicide, bactericide or anti-viral agent, which iε εuch that it iε εlcwly releaεed _in εitu. Certain em odimentε cf the barrier device according to the invention are εuitable for use aε male condoms; further embodiments are εuitable for uεe aε SUBSTITUTESHEET fe ale condoms; and still further embodiments are εuitable for uεe aε either, according to choice. .hen the device iε intended for uεe aε a female condom, the open end of the pouch preferably has, integral therewith, a continuous liquid-impermeable peripheral flange arranged to cover the vulva (around the periphery of vaginal entrance). In this case, the barrier device may be employed together with an elongate applicator body (in the form of a rod or the like) which iε arranged to introduce the pouch into the vagina and be withdrawn therefrom, so aε to leave the pouch in place. \hen the applicator body iε thus withdrawn, the biaεεing meanε acts to retain the pouch in place in the vagina. It iε preferred that εuch a peripheral flange should have bonded thereto on the vulva-contacting εurface and/or on the vagina contacting εurface a continuoυε coating layer of an adhesive material which iε εuch that it can temporarily adhere the surface to mucous membrane material in the presence of aqueous body luids. "Ihe uεe of such a coating layer iε believed to be novel per εe; the preεent invention therefore further co priεeε a barrier device compriεing a continuous liquid-impermeable shield member shaped and dimensioned so that, in its operational position, it substantially covers a user's vulva, the shield member having integral therewith a continuous liquid-impermeable flexible pouch arranged to be introduced into the uεer'ε vagina εo aε to form a liquid barrier during coituε between the vagina and the penis; and meanε for securing the shield member in the operational position, in which the vulva-ccntacting εurface of the εhield member and/or the vaginε-contacting εurface of the pouch haε bonded thereto a substantially continuous coating layer of an adhesive material which iε εuch that it can temporarily adhere said barrier device to mucous membrane material in the presence of aqueous body fluids. SUBSTITUTESHEET An example of a preferred adheεive material iε a hydrogel-type material, which is preferably a hydrophilic synthetic polymer. Examples of suitable εuch pcly erε are polymers of vinyl pyrrolidone, hydroxyalkyl acr lates or methacrylateε, or an ac^lεmide; such polymers generally have (in addition to temporary adhesive properties for holding the device in place in the vagina), lubricating properties. Such an adheεive coating layer or layerε preferably contains, in addition to a hydrophilic polymer vehicle, a physiologically acceptable fungicide and/or bactericide, and, most preferably, a εpermicide. It iε particularly preferred to incorporate a εpermicide, such aε an ethcxylate alcohol (for example, the material commercially available under the trade mark "I oncxinol", which iε also believed to have anti-viral propertieε) in the coating layer. In a further preferred embodiment of the invention, the internal surface (that iε, the penis-contacting εurface) of the device according to the invention is itεelf provided with a preformed coating layer having lubricating prcpertieε; an example of a εuitable type of coating layer iε a layer compriεing a hydrogel polymer aε deεcrited above. Ihe εheath may be of any εuitable rubber or plaεticε material; by way of example, the εheath may be of dipped rubber (of, for example, natural rubber), pclyurethane or the like. It iε preferred that the εheath and the εhield member should together ccnεtitute a εeamlesε unitary body. Ihe preεent invention further ccmpriεeε a modification of the female condom device juεt described, which compriseε a device for use by either a male or female uεer in which the pouch iε arranged to be introduced into the anal paεεage of the user. In this modification of the invention, the peripheral flange iε arranged to cover the periphery of the anal passage, and all references herein to "vagina" and "vaginal walls" are, when relevant to this embodiment, to be construed aε reεpectively reference to the anal paεεage and the wallε thereof. SUBSTITUTESHEET A preferred embodiment of the present invention will new be described with reference to the accompanying drawings, in which: Figure 1 is a longitudinal sectional view of an exemplary barrier device according to the invention, together with an applicator therefor; Figure 2 iε a plan view of an insert for a barrier device such aε that εhewn in Figure 1; Figure 3 is a sectional view along line A-A in Figure 2; and Figure 4 is a longitudinal section of the device of Figure 1 when in the process of being inserted into the user's vagina by means of an applicator. Referring to figure 1, there iε shown a barrier device in the form of a thin, flexible pouch 1 having an open end 2 in the form of a peripheral flange with a peripheral ribbed rim 3, and a closed end 4, the portion of the pouch between the open and closed ends being folded in upon itεelf within an applicator body 11. Ihe closed end 4 has a teat-like projection 5 (with a corresponding receεε in the internal εurface thereof) . Ihe applicator body 11 iε in the form of an inwardly tapering tube, tapering from a flanged end 12 to a narrowed end 13; integral with the flanged end 12 iε a further tapering tubular portion 14, tapering inwardly in the direction leading away f om narrowed end 13. 1apering portion 14 ter inateε with a generally cylindrical portion, which engageε with the external εurface of an applicator rod 15 having a gripping portion 15a and a portion 15b which iε to be inεertec into the applicator body; the latter portion iε of reduced diameter relative tc the gripping portion and connected thereto by a tapered εhoulder 21. Ihe connection 22 between the εhoulder 21 anc portion 15b iε of εlightly increaεed diameter, so aε tc inhibit inadvertent withdrawal cf the applicator roc from the applicator body. he tip 16 of the end portion 15t SUBSTITUTESHEET (which iε typically part-spherical) engages with insert 1/ within the cloεed end 4 of barrier device; the insert acts to protect the material of the pouch during insertion thereof into the vagina by means of the applicator rod 15. Referring to Figures 2 and 3, the inεert 17, which iε typically of flexible expanded plaεtics material having disperεed therein a εpermicide and/or an antiviral agent, comprises a central portion It having a generally part-spherical recess IS (shaped to receive the tip 16 of applicator rod 15), and (extending radially outwardly from central portion 1&) four spurs 2Ga, 2Gb, 2Gc, 2Gd. Ihe obverse of central portion 18 has a button-like projection 1G capable of engaging the receεε in the internal εurface of the cloεed end 4 cf pouch 1 (see Figure 4) . In operation, aε illuεtrated in Figure 4, the pouch 1 and the applicator tody 11 are together inserted into the user'ε vagina in the orientation εhown in Figure 1; applicator rod 15 iε then pushed manually in the direction of arrov B so aε to extend the pouch to itε fulleεt extent within the vagina, to the orientation shown in Figure 4. Ihe projection 1G engages the closed end of the pouch 1 so that the inεert 17 iε correctly located. \hen the rod haε been fully inεerted, the spurs 2Ga, 2Gb, 20c, 2Cd open out to cause the cloεed end 4 of the pouch tc engage with the vaginal walls 30; the applicator rod 15 and the applicator body 11 are then withdrawn, leaving the pouch in place with the open end 2 in contact with the vulva 31. Ihe open end 2 of the pouch may be provided with an adhesive coating of the type deεcribed above en the vulva-contacting εurface. ISTΪTUTE SHEET

Claims: CLAIMS : 1. barrier device comprising a continuous, liquid- impermeable, flexible pouch having an open end and a cloεed end εuch that the pouch can form a liquid barrier between a penis and a vagina; and a soft reεilient inεert arranged for insertion in said pouch between the tip of the peniε and said closed end, said insert comprising a generally central portion and, extending outwardly from said central portion, means for biassing said pouch in the vicinity of said cloεed end into contact with the walls of the vagina. 2. A barrier device according to claim 1, wherein said insert iε absorbent. 3. barrier device compriεing a ccntinuouε, liquid- impermeable, flexible pouch having an open end and a cloεec end such that the pouch can form a liquid barrier between a penis and a vagina; and a soft absorbent resilient insert arranged for insertion in said pouch between the tip of the penis and said cloεed end, εaid insert being arranged for biassing εaid pouch in the vicinity of said closed end Into contact with the walls of the vagina. 4. A barrier device according tc any of claims 1 to 3, wherein εaid reεilient inεert comprises flexible expanded polymeric material, εponge rubber, solid rubber or plaεticε material. 5. A barrier device according tc any of claimε 1 to 4, wherein εaid inεert compriεeε a central tody portion and a plurality of radiall}-- outwardly projecting εpurε. 6. . barrier device according tc claim 5, therein there are three or four of εaid εpurε. SUBSTITUTESHEET 7. A barrier device according to claim 5 or 6, wherein εaid body portion has a central depresεion for receiving the tip of an applicator rod or the like. S. A barrier device according to claim 7, wherein εaid body portion further comprises a formation on the face remote from εaid depression, εaid formation being arranged tc engage with a complementary formation provided on the peniε-contacting surface of εaid pouch, such that the inεert tends to be retained in poεition when the pouch iε inεerted in the vagina. . A barrier device according tc claim t>, wherein εaid formation en said body portion comprises a protrusion and εaid complementary formation on εaid internal surface of εaid pouch comprises a depression capable of receiving said protrusion. 10. barrier device according to any of claims 1 to S, wherein an adhesive coating iε provided on the insert and/or on the internal surface of the pouch. 11. A barrier device according to any of claims 1 tc 10, wherein εaid insert containε a εpermicide and/or a fungicide, bactericide or anti-viral agent, which iε such that it is slowly released XΏ situ. 12. A barrier device according to any of claims 1 to 11, wherein said open end of said pouch has, integral therewith, a continuous liquid-impermeable peripheral εhield member arranged to cover the vulva. 13. A barrier device according to claim 12, wherein the εheath and the εhield member together conεtitute a εea leεε unitary body . SUBSTITUTESHEET 14. A barrier device according to claim 12 or 13, wherein said peripheral flange has bonded to the vulva-contacting surface and/or to the vagina-contacting surface thereof a continuous coating layer of an adhesive material which is εuch that it can temporarily adhere the surface to mucous membrane material in the presence of aqueouε body fluids. 15. A barrier device comprising a continuous liquid-impermeable εhield member shaped and dimensioned so that, in its operational position, it subεtantially coverε a uεer'ε vulva, the shield member having integral therewith a continuouε liquid-impermeable flexible pouch arranged to be introduced into the uεer'ε vagina so as to form a liquid barrier during coituε between the vagina and the peniε; and means for εecuring the εhield member in the operational position, in which the vulva-contacting surface of the shield member and/or the vagina-contacting surface of the pouch has bonded thereto a substantially continuous coating layer of an adhesive material which iε εuch that it can temporarily adhere εaid barrier device to mucous membrane material in the presence of aqueouε body fluidε. 16. A barrier device according tc claim 15, wherein εaid εhield member is in the form of a flexible flange surrounding the open end of the pouch. 17. A barrier device according to any of claims 14 tc 16, wherein εaid adheεive material iε a hydrogel-type material It . A. barrier device according to any of claimε 14 to 17, wherein εaid adheεive material containε, in addition to a hydrophilic polymer vehicle, a physiologically acceptable fungicide and/or bactericide, and/or a εpermicide. SUBSTITUTESHEET lS. A barrier device according to any of claims 15 to 18, wherein said coating layer iε a substantially complete covering for the vulva-contacting surface of the shield member and/or for at least part of the vagina-contacting surface of the pouch. 2G. A barrier device according to any of claims 15 to IS, wherein said pouch is of dipped rubber. 21. barrier device according to claim 20 as appendant to claim 17, wherein the hydrogel polymer iε applied from an aqueous solution prior to complete vulcanisation cf the rubber, followed by full vulcanisation of the latter. 22. barrier device according to any of claims 1 to 21, in combination with an elongate applicator body which iε arranged to introduce the pouch into the vagina and be withdrawn therefrom, εo aε tc leave the pouch in place. 23. barrier device according, to any cf claimε 1 to 22, wherein the peniε-contacting εurface of the device iε provided with a preformed coating layer having lubricating properties. 24. A modification of the barrier device according to any of claimε 1 to 23, for uεe by either a male or female uεer, in which the pouch iε arranged to be introduced into the anal passage of the user inεtead of into the vagina. SUBSTITUTESHEET

Inventors: RICHARDSON MARGARET PAMELA, RICHARDSON PHILIP, RICHARDSON, MARGARET, PAMELA, RICHARDSON, PHILIP
Applicants: RICHARDSON MARGARET PAMELA, RICHARDSON PHILIP, RICHARDSON, MARGARET, PAMELA, RICHARDSON, PHILIP
Application year: 1989
Main classification: A61F6
IPC codes: A61F6