Prophylactic device

Abstract: A prophylactic device (10) is described which is adapted to be worn by a person to prevent the transmission of dis­ ease and sperm during sexual intercourse. The device may be adapted for use by a female person or by a male person. The device includes an elongated hollow pouch (12) which has an open end (16) and a closed end (14). The pouch has a thin wall member which is flexible and elastic. A continuous flange member is attached to the open end of the pouch and ex­ tends outwardly around the opening in the pouch. Attachment means secured to the flange attaches the device to the per­ son wearing it. The device may be in the form of a garment worn by the person.

Description: This invention relates to prophylactic devices. More particularly, this invention relates to prophylactic devices which are highly effective in preventing the transmission of venereal diseases and AIDS. Even more particularly, this invention relates to prophylactic devices which may be used by females. With the widespread occurrence of venereal diseases and AIDS (Acquired Immune Deficiency Syndrome), there is an increasing need for an effective means of preventing the transmission of such diseases through sexual contact. Conventional means for preventing the transmission of such diseases include the use of condoms, diaphragms, gels, creams, etc. However, such conventional means are not totally effective, even when they are used in combination with one another. There has not heretobefore been provided an effective prophylactic device for female persons which prevents the transmission of diseases during sexual intercourse. The prior prophylactic devices for female persons which have been used heretofore include U.S. Patent No.3,536,066. The device includes a flat shield portion and an extendible pouch in the form of a bellows formed proboscis with an open end and with a closed end spaced from the open end. The proboscis is joined to a pant style unitized garment. The contraceptive device of the -066 Patent includes an insertable portion of a bellows which is positioned in the vaginal canal of a female prior to use. Thereafter, the bellows is expanded by an erected penis to provide for expansion of the bellows during coitus with the female person on which the contraceptive device is used. The device requires pre-insertion and does not include means for piloting a large pouch-like member into the vaginal canal. Furthermore, the garment portions thereof are in contact with a large part of the waist region of a user so as to cause possible irritation and discomfort. German Patentschrifft No.210413 (1909) discloses a female contraceptive device having a proboscis, or pouch, on one end thereof and having a generally circular collar on the other end thereof which covers a small part of the entrance to a vaginal canal or other bodily orifice. U.S. Patent No.4,735,621 or CH-A-117 234 likewise shows a thin walled condom-like tubular protective device for insertion in a vaginal canal. It includes a resilient ring on one end thereof to provide an internal anchor, much like a diaphragm. The prophylactic device of the -621 Patent includes a collar on its entrance end which, again, is limited to covering a small part of the entrance to the vaginal canal. The device requires hand insertion to set the internal anchor and thereby exposes a user to bodily fluids and possible transmission of diseases through lesions of the like during the hand transfer and placement of the contraceptive device in the body orifice. Each of the aforesaid prophylactic devices are characterised by either providing a limited exterior cover at the opening of a body cavity such as a vaginal canal or alternatively a garment type prophylactic device that will cover the full body of a user below the waist. The first type of prophylactic device requires separate hand insertion into the vaginal canal, thereby exposing a user to the bodily fluids therein and the second type of device is uncomfortable if worn for extended periods prior to use. According to the invention there is provided a prophylactic device for use by a woman having a flat shield portion and an extendible pouch with an open end joined to the shield portion and with a closed end spaced from the open end, characterised by said pouch having a double walled rolled ring disposed adjacent said shield portion extendible to form a single walled piloting segment having a length less than that of the fully extended pouch. Preferably said closed end has a retention device thereon for urging the closed end into an expanded position for retaining the pouch in place. A prophylactic device in accordance with the invention is now described hereinafter by way of example with reference to the accompanying drawings, wherein like reference characters refer to the same parts throughout the several views and in which:- Fig.1 is a diagrammatic view of dipping and tilting steps in a process of the present invention for manufacturing anatomically configured prophylactic devices in accordance with the invention, Fig.2 is a diagrammatic view showing a stripping step of such process steps of Fig.1, Fig.3 shows a rolling step wherein telescoped segments of the pouch are rolled into generally the same plane as that of the shield portion of such prophylactic device, Fig.4a is an enlarged sectional view of a segment of a partially de-telescoped pouch, Fig.5 is a perspective view of a first fold step in packaging a prophylactic device formed by the steps of Figs.1 through 4a, Figs.5a - 5c are perspective view of an embodiment for folding the prophylactic device, Fig.6 is a rolling step for configuring the folded prophylactic device of Fig.5 in a tubular form for subsequent packaging, Fig.7 is an exploded view of a folded and rolled prophylactic device in an aligned, pre-assembled relationship with a tubular container for such prophylactic device, Fig.8 is a front elevational view of another embodiment of the prophylactic device, Fig.9 is an end elevational view of the embodiment of Fig.8, Fig.10 is a side elevational view of the Fig.25 embodiment, Fig.11 is a perspective view of an anatomically configured hermaphroditic embodiment of the invention suitable for a male or female person shown in position on a male person, Fig.12 is a fragmentary sectional view taken along the line 12 - 12 in Fig.11, Fig.12a is a view showing the prophylactic device of Figure 12 in a first extended position for piloting the pouch portion thereof into a body cavity of either a male or a female person, Fig.12b is a sectional view showing the pouch portion of the prophylactic device of either Fig.11 or Fig.12 in a fully extended position within the body cavity of a male or female person, Fig.12c is a sectional view showing the dimensional relationship of an anatomically configured hermaphroditic prophylactic device with the pouch portion thereof extended and in spaced relationship to an erected penis within a vaginal canal to provide freedom of and lateral movement with respect to the inner walls of the extended pouch portion of such prophylactic device, Fig.12d is a fragmentary view of the pouch wall at the clitoral region of a vaginal canal, Fig.12e is a fragmentary view of a stroking roll in the pouch wall of Fig.12d, Fig.13 is a diagrammatic view of a further embodiment of an anatomically configured hermaphroditic prophylactic device on a female person, Fig.13a is a cross section through part of a fastener arrangement used in the device of Fig.11, Fig.14 is an enlarged fragmentary detail of a releasable fastener for securing a shield portion of the prophylactic devices of Fig.13 to garments or components thereof, Fig.15 is a partially cut away, perspective view of an embodiment of a prophylactic device of the invention, Fig.15a is a cross-sectional view of a portion of the device of Fig.15, Fig.16 is a cross-sectional view of a portion of another device of the invention and Fig.17 is a perspective view of an inelastic plastic film embodiment of the present invention. A prophylactic device 120 in accordance with the present invention is formed by a process as set forth in Figs.1 through 3. The process includes a mold 220 having a flat surface 222 thereon of a planar extent corresponding to that of the planar extent of the shield portion 122 bounded by the bead 134. The bead 134 is initially disposed at a bead support ridge 126 around the periphery of the flat surface 122. The flat surface 222 has a protuberance 224 extending outwardly. The protuberance 224 has an outer surface 226 thereon dimensioned to correspond to that of the inside surface of the extended pouch 155. Then, the mold 220 is connected to suitable carriage means for movement into an open ended container 228 that has a body of synthetic or latex material 230 therein of a composition as discussed in the earlier embodiments, which can be deposited on the surfaces 222, 226 to form a resultant thin layer deposit thereon. The deposit can be formed by a single or double dip process which includes directing the mold 220 along a path 232 into the body of material 230 to form a layer of material on the surface 226. When the mold 220 is located in the dotted line position shown in Fig.1, it can be tilted about an arc 235 so as to deposit a thin layer of material across the surface 222. The resultant deposited material is shown in Fig.2. The deposited material is stripped from the mold 222 by relative movement between the formed shield portion 122 and the flat surface 222 of the mold 220 whereby the shield portion 122 assumes the dotted line position shown by reference numeral 236 in Fig.2. This causes the pouch portion of the prophylactic device to be telescoped upon itself to form a double wall telescoped segment 238. The double walled telescope segment 238 is then engaged by suitable means such as rollers 240 to roll the telescoped double wall portion 238 upon itself from a return bend portion 242. The resultant rolled ring 148 has an outer wall segment 148d which will unroll as the ring 148 assumes its piloting position 148b. It has an inner wall segment 148e which will unroll after the pilot portion 152 is positioned. This rolled ring 148, as previously discussed, disposes the end closure 146 of the prophylactic device in close spaced parallelism with the bead 134 as in Fig.4 which has latex formed therearound to form the perimeter of the prophylactic device 120. The rolling of the ring 148 will remove the prophylactic device 120 from the form 220. The removed prophylactic device 120 can then be readily manipulated for various forms of storage. For example, in Figs.5 through 7, the prophylactic device 120 removed from the mold 220 can be folded end to end and then rolled from a joined end portion 240 to form a tubular configuration shown at 250 in Fig.7. The tubular configuration is readily insertable into the interior of an elongated container 260 which is representatively shown as having a cap closure 262. In this arrangement, each of the individual prophylactic devices 120 are packaged separately from the garment or strap systems for connecting the prophylactic device 120 for male or female use. As previously discussed, the universal prophylactic device is anatomically configured to extend over the perineum regions of either a male or a female user to shield such regions from bodily fluids during use. The prophylactic device 120, as stripped from the mold 220, is also readily foldable as shown in Fig.5a to form a first joined end region 256 which can be folded on itself to form a second folded end region 258 that can be made even more compact by folding back upon itself to form a third fold region 260 (Fig.5b) thereby to define an eight layered compact condom package 262 that is readily adapted for packaging in compact, flat container configurations representatively shown at 264 in Fig.5c. Another embodiment of the present invention is illustrated in Figs.8 through 10. They show an anatomically configured, hermaphroditic prophylactic device 120. The folded unit 120 includes a generally rectangularly configured shield portion 122 having a narrow central segment 124 and a pair of end wing segments 126, 128. The wing segments 126, 128 have a gradually tapering width which is bounded by a pair of segments 130, 132 of a continuously formed peripheral bead 134 which converge from a first end segment 133. A like pair of bead segments 136, 138 formed on the sides of the wing portion 126 converge from a second end segment 135 of the peripheral bead 134. Segments 136, 138 are joined to central bead segments 140, 142 that are located in spaced parallelism. They are joined respectively to the inwardly convergent bead segments 130, 132. The prophylactic device 120 further includes an integrally formed pouch 144 that is centered in the center region 124 of the shield portion 122. The pouch 54 has an entrance opening 145. The pouch member includes an end closure 146 that is joined to a rolled ring 148 that is formed during a manufacturing process to be described. The rolled ring 148 and the end closure 146 are located on the inner surface 150 of the prophylactic device 120. More particularly, the inner surface 150 has a length from the extreme ends of the wing portions 126, 128 and a width at the center region 124 to anatomically fit either a male or female user to provide complete coverage of the perineum regions of a user to prevent bodily fluids from contacting such regions during use of the prophylactic device 120. As shown in Fig.9, the rolled ring 148 has a prepackaged position 148a, a piloting position 148b and a fully extended position 148c (Fig.12d). In the various embodiments of prophylactic devices of this invention, the sizes and thicknesses of the materials may vary. For example, the pouch member may have a length in the range of about 25 to 254mm (preferably about 101 to 152mm) (1 to 10 inches (preferably about 4 to 6 inches)) and a diameter of about 25 to 101mm (1 to 4 inches). Although the pouch member may have a uniform diameter throughout its length, the diameter could vary if desired. More specifically, in the illustrated arrangement in Fig.8, the shield portion 122 has a length L in the order of 22cm. The maximum width WM of the wing portions 126, 128 is in the order of 12cm and the center region 124 has a width W of 9.5cm and a height H of 6cm. The thickness of the wall material of the pouch 144 and the shield portion 122 may also vary. For example, it may be as thin as 0.0127mm (0.0005 inch) or as thick as 2.54mm (0.1 inch). Preferably it is in the range of about 0.254 to 0.127 mm (0.001 to 0.005 inch). The pouch and the shield portion 122 are preferably made of elastic, impermeable material such as natural rubber or synthetic rubber (e.g., silicone elastomer or rubber). Useful materials also include nonelastic materials such as plastic (e.g., polyurethane, polyvinylchloride, etc.) The aforesaid dimensions are configured to anatomically relate to the perineum region of either a female user of the device or a male user of the device wherein the pouch 144 can be rolled from its stored position in close spaced parallelism with the plane of the shield 122 to an extended position within a body cavity of a user. One aspect of the present invention is that the rolled ring portion 148 is configured so that the pouch 144 will unroll to form a single wall piloting segment 152 shown in dotted line configuration in Fig.9 upon first entry into the body cavity. The piloting segment 152 will be varied by further entry into a body cavity by unrolling the rolled ring segment 148 from the shield portion 122 until the pouch 144 is fully disposed as depicted at 155 within the body cavity (Fig.12d). The anatomically configured, hermaphroditic condom 120 shown in Figs.8 through 10 is suitable for use on a female person as shown in Fig.13. In this embodiment, the prophylactic device 120 is representatively shown as being connected to a bikini-like panty garment having an elastic waist portion 184 with a buttocks engaging back panel 186 and a shallow frontal segment 188. The back garment panel 186 is connected to the corner regions 128a, 128b of the wing segment 128 by male snap segments 190 on straps 192 to engage female snap components 194 secured to the corner of the rear panel 186 of the bikini-like garment. A like snap fastener assembly 196 connects the opposite corner of the rear panel 186 to the corner region 128a of the wing portion 128. The front segment 184a of the elastic waist carries a plurality of straps 198a, b, c and d each having a male snap formed thereon which, as shown in Fig. 13a includes a male fastener element 202 on the strap 198a which is pressed through the corner segment or an edge of the wing segment 126 to engage a female snap element 204 on the inner surface at the lower edge of the shallow frontal segment 188. The garment for carrying the prophylactic device 120 can also be in the form of a strap system as shown in Fig.11 in which case the small straps 156, 158 will be located on the front of a female and the back long straps 160, 162 will extend around the rear buttocks of a female user of the prophylactic device 120. In either case, the prophylactic device 120 is located so that the end closure 146 is disposed in covering relationship to the vulva 204 at the entrance to a vaginal canal 202 (Fig.12d). The inner surface 150 of the shield portion 122 is thus disposed in protective overlying juxtaposed relationship with the vulva 204 and also covers the perineum regions 208 of the user extending from the upper region of the pubic area to the perineum in the region of the anal orifice or canal of the female user. Thus, a substantial portion of the bodily surface of a female user is covered by the anatomically configured, hermaphroditic prophylactic device 120 without placing a substantial portion of an elastic or plastic like synthetic material against the outer surface of the user. Consequently, the device can be worn prior to use without discomfort. The initial position of the prophylactic device 120 is shown in Fig.12c at which point a portion of the exterior body surface of the female is covered by the contraceptive device 120 to protect against bodily fluid exchange during normal use. The prophylactic device 120 can be carried either on a strap system of the type shown in Fig.11 or on a bikini like garment. Prior to extension of the rolled pouch 144 the prophylactic device 120 is disposed in overlying relationship but out of engagement with the vulva 204 and other portions of the female person using the prophylactic device. The end closure 146, however, is positioned for ready disposition of the piloting segment 152 of the pouch 144 into the vaginal cavity 202 when a penis is inserted thereagainst to extend the pouch freely into the vaginal cavity 202. The length of the pouch 144 is greater than that of an erected penis and will have a dimension which is great enough to extend the pouch to form a loose fitting cover of the walls of the vaginal cavity 202 as shown in Fig.15c in diagrammatic form. One feature of the present invention is that a forwardly located wall segment 146a of the extended pouch is located in overlying relationship to the clitoral region of a female user. Stroking movement of the penis within the vaginal canal will occur without undue contact between the glans region of the penis and the walls of the extended pouch 155. The wall segment 146a is joined to the flat shield portion 122 at an exterior anchor point 122a thereof. The exterior anchor point 122a and the wall segment 146a are operative during insertion and withdrawal of a penis from the interior of the extensible pouch to produce a rolling of the wall section 146a for pleasurably stimulating the clitoral region during intercourse. Consequently, the prophylactic device 120 will not interfere with pleasurable use thereof during coitus. The closed end of the pouch optionally includes a resilient member which is adapted to be gripped and retained in position by the vaginal muscles (i.e., the labia muscles). Thus, when the pouch is inserted into the vagina the labia muscles are capable of gripping and retaining the closed end 14 of the pouch in the position shown. The resilient member at the closed end of the pouch may be a resilient disc 50 (as illustrated in Fig.16) which is preferably flexible. The disc may be made of rubber or plastic. Preferably it is molded as an integral part of the pouch wall 52. Another embodiment of resilient member is illustrated in Figs.15 and 15A where it comprises a disc member 40 which includes a ring shaped spring or wire 41. The disc 40 may be deformed or folded to facilitate insertion into the vagina, and then the spring or wire 41 urges the disc member back to its original circular shape. The disc member 40 may be formed as an integral part of the wall member of the pouch 42 or it may be formed separately and the bonded to the wall member. In yet another embodiment of the invention, shown in Fig. 17, a plastic pouch 270 is formed from two thin film sheets 272, 274 of plastic that are joined at their periphery 276. Suitable plastic film material contemplated by the invention includes polyvinylchloride, polyurethane or polypropylene. The pouch 270 in this embodiment can be inelastic. However, it is dimensioned to provide freedom of movement of an erected penis with respect to a shielded vaginal canal and is also configured to be rolled and unrolled with respect to a shield portion 278 of a configuration like shield portion 122. In this embodiment, the pouch 270 has a flange 271 for attachment by suitable means around an entrance opening 280 in the shield portion.

Claims: A prophylactic device for use by a woman having a flat shield portion (122) and an extendible pouch (144) with an open end (145) joined to the shield portion and with a closed end (146) spaced from the open end, characterised by said pouch having a double walled (148d, 148e) rolled ring (148) disposed adjacent said shield portion (122) extendible to form a single walled piloting segment (152) having a length less than that of the fully extended pouch. A prophylactic device of Claim 1 further characterised by said closed end (146) having a retention device (42) therein for urging the closed end into an expanded position for retaining the pouch in place. The prophylactic device of Claims 1 or 2 further characterised by said closed end (146) comprising a resilient disc (50).

Inventors: REDDY ALLA VENKATA KRISHNA, REDDY, ALLA VENKATA KRISHNA
Applicants: REDDY ALLA VENKATA KRISHNA, REDDY, ALLA VENKATA KRISHNA
Application year: 1988
Main classification: A61F6
IPC codes: A61F6