SPERMACIDAL CONDOM

Abstract: A spermicidal contraceptive sheath and method of manufacture are oisclosed. The sheath has a first sperm­ cide-containing material inside the sheath at the closed end thereof. A second spermicide.containing lubricant is pro­ vided at least on the outside surface of the sheath. A dose of spermicide is automatically provided both on the outside of the sheath and on the inside. If the sheath ruptures, a douple dosage of spermicide is available to provided an extra measure of contraceptive erectiveness.

Description: SPERMICIDAL CONDOM The present invention pertains to condoms and, more particularly, to a condom or contraceptive sheath that is provided with spermicide-containing lubricant to provide an extra measure of effectiveness against conception, and a method of manufacture. - Contraceptive devices such as condoms comprising contraceptive sheaths for insertion upon the male organ have long been used as a means for preventing conception. The sheaths are typically made of latex rubber, are generally tubular, and have a closed end and an open end. Conventional contraceptive sheaths are often provided with lubricants comprising a synthetic polyether, such as polyethylene glycol. It has long been a problem with conventional contraceptive sheaths that they occasionally fail to prevent conception. The failure frequently results from a rupture of the thin wall of the sheath, usually at the tip which is subjected to stresses such as stretching. Failure also occurs from the tendency of improperly fitted sheaths to roll up during and after use. An attempt to overcome the foregoing problems is disclosed in British Patent No. 1,142,443 which discloses a sheath having a constricted portion spaced from the closed end to form an improved fluid tight seal with the male organ. However, no means of preventing conception is disclosed for instances where the sheath ruptures or the sheath nevertheless rolls up. Another attempt at solving the foregoing problems is disclosed in British Patent No. 1,268,637 which discloses a contraceptive sheath which has polyether applied thereto as a lubricant. The polyether can be applied in aqueous solution or in combination with a spermicide to render the sheath more contraceptively efficient. It is a disadvantage of this arrangement that an effective amount of spermicide is not provided inside the sheath at the tip thereof. Accordingly, when the need for the spermicide arises, the sheath can fail to kill the sperm, as is required. Other attempts to overcome these problems have been made by using contraceptive sheaths in conjunction with spermicide foams, jellies, or suppositories, thereby relying on two separate methods of contraception. The use of the spermicide in this manner has the disadvantage of inconvenience in that the male and femal must have the forethought and planning not only to have both the spermicidal preparation and sheaths on hand, but also to insert the spermicidal preparation at some predetermined, recommended time interval prior to intercourse. The foregoing disadvantages of the prior art are overcome in accordance with the present invention, which provides a spermicidal contraceptive sheath and a method of manufacture. The contraceptive sheath has a closed end and an open end, and has an outside surface and an inside surface. In one embodiment a spermicide-containing material is provided on the inside surface of the closed end of the sheath. The material has a coefficient of friction sufficiently high that it remains on the inside surface of the sheath. In a more preferred embodiment in addition to the above-described first spermicide-containing material a spermicide-containing lubricant is provided on the outside surface of the sheath. A first dosage of spermicide is thereby available within the sheath and a second dosage of spermicide is available outside the sheath thereby to provide a more effective arrangement for preventing conception. A method of manufacturing a spermicidal contraceptive sheath in accordance with the present invention comprises the steps of providing a contraceptive sheath having a closed end and an open end, an outside surface and an inside surface, applying a first spermicidecontaining material on the inside surface of the closed end of the sheath, applying a spermicide-containing lubricant on the sheath, in such manner that such lubricant will be disposed on the outside surface of the sheath, thereby providing one dosage of spermicide within the sheath and another dosage of spermicide outside the sheath. It is a feature of the present invention that a dose of spermicide is automatically available both on the outside of the condom and on the inside. In the event theXcondDm should rupture, a double dosage of spermicide is available due to the combination of the dosage inside the condom and the dosage outside. If the condom should accidentally come off, or if there is a rupture subsequent to ejaculation, the spermicide would already have killed substantially all of the sperm inside the condom. Accordingly, an extra measure of contraceptive effectiveness and protection is available with the present invention. In the event that the condom does not rupture or become accidently removed, then each partner is only exposed to a single dose of the spermicide. In the drawing: Figure 1 is a schematic illustration of a spermicidal contraceptive sheath in accordance with the present invention, in which a first spermicide-containing material is being applied to the sheath; Figure 2 is a cross-sectional view of the sheath after the spermicide-containing material is fully received therein; Figure 3 is a schematic illustration of the sheath while a second spermicidal composition, comprising a lubricant is applied thereto; Figure 4 is a cross-sectional view of the sheath after the second lubricant-containing, composition is fully received therein; and Figure 5 is a cross-sectional view of the sheath after the passage of time which enables the lubricant to spread along the surface of the sheath. While this invention is susCeptible of embodiment in many different forms, there is shown in the drawing and will herein be described in detail one specific embodiment, with the understanding that the present disclosure is to be considered as an exemplification of the principles of the present invention, and is not intended to limit the invention to the embodiment illustrated. Referring to the drawing, Figures 1 and 2 show a conventional contraceptive device or sheath 10. The sheath comprises a condom or prophylactic device which is made of any suitable material, such as latex rubber, in the form of a flexible and resilient hollow tubular sheath. The sheath 10 has an upper open end 12 (Figure 1) for insertion of the male organ therein and a sloping, lower closed end 14 which is generally hemispherical and comprises a nipple that acts as a barrier against the seepage of fluids from the discharge zone of the organ disposed in the interior of the sheath. The sheath also includes an elastic peripheral portion 16 which defines the open end 12 of the sheath. The elastic portion engages the body portion of the organ when the device is in its operative position so as to provide a seal against the flow of fluid into and out of the interior of the device. The elastic portion 16 provides a band upon which the wall 18 of the device is rolled when the device is not in use. In the position shown in the illustrated embodiment, a major portion of the wall 18 of the sheath is rolled about the elastic portion 16. The sheath also includes an inside surface 20 and an outside surface 22, as illustrated in Figure 2. Referring again to Figure 1, a pair of extruders are shown for metering predetermined quantities of spermicide-containing material to the contraceptive sheath 10. Shown schematically are a first extruder 24 having a nozzle 26 and a second extruder 28 having a nozzle 30. A first spermicide-containing material is provided in the extruder 24, and a metered quantity is applied to the inside surface 20 of the closed end 14 of the sheath 10. During the manufacturing process, the sheath 10 is held upright as shown in Figure 1, and the predetermined quantity of the first lubricant 32 can be fed to the closed end of the sheath by means of gravity, with the nozzle 26 being positioned directly above the closed end 14 of the sheath. The first spermicide-containing material is applied to the sheath in liquid form, and may comprise a solid that is heated past the melting point in extruder 24, and is applied in melted form to the sheath, where it will solidify upon cooling. Where the first spermicide-containing material 32 is a form that will solidify upon cooling, it preferably has a melting temperature that is slightly below or about equal to the body temperature, so that it will be melted when the condom is in use for the first spermicide-containing material to be in liquid form in the event that it is needed as a spermicide. Alternatively, the first lubricant 32 may be in the form of a semi-solid, such as an ointment or cream. The first spermicide-containing material 32 is disposed substantially entirely within the closed end 14 of the sheath. The first spermicide-containing material therefore has a sufficiently high coefficient of friction to retain it on the inside surface of the closed end of the sheath, thereby to prevent migration of the first material by means of capillary action. Referring to Figure 3, a second application of spermicide, contained in lubricant 34 is made to the sheath after the first lubricant is fully received within the sheath. The lubricant 34 is provided within the extruder 28, and a metered quantity is fed to the sheath by means of the nozzle 30. The nozzle 30 is positioned directly above the sheath, and the lubricant 34 is applied on top of the first lubricant by way of gravity. Immediately after the lubricant 34 is applied to the sheath, it is disposed within the closed end 14 of the sheath, above the first material 32, as depicted in Figure 4. It is desired to have the lubricant provided on the outside surface of the sheath 10, so that the dosage of spermicide provided by the second lubricant is available for the female. Accordingly, the lubricant may be applied directly to the outside surface of the sheath, if desired. Alternatively, when the lubricant 34 is of the type that has a sufficiently low coefficient of friction to spread by means of capillary action to both the inside surface 20 and outside surface 22 of the sheath the lubricant 34 can be applied to the inside of the sheath, as shown in Figure 4. The spreading will take place even while the sheath is rolled about the peripheral portion 16. The migration of the lubricant along the inside surface and the outside surface will typically occur during a twenty-four to fourty-eight hour period. The final product is shown in Figure 5. The first material 32 is disposed substantially entirely within the closed end 14 of the sheath, and the lubricant 34 is disposed about the entire outside surface 22 of the sheath, and the entire inside surface 20 with the exception of the portion that is already covered by the first material. In accordance with the foregoing, the sheath 10 has a relatively large first dosage of spermicide contained within the closed end 14 of the sheath, which is the tip where most ruptures occur. As a result, sperm that is released from the condom would substantially all be killed by the spermicide which is provided in that location. A second dose of spermicide is provided on the outside surface of the sheath, which is received by the woman. Thus, if the sheath ruptures, a double quantity of spermicide is available--one dose from the inside and a second dose from the outside. Accordingly, an extra measure of contraceptive effectiveness is available over a standard condom, while exposing each person to only a single dose of spermicide if no rupture occurs. The first material 32 preferably comprises an ointment or cream which is in semi-solid form. By way of example, the first material 32 may comprise a mixture of 30% by volume of polyethylene glycol 3350, 63.48 by volume polyethylene glycol 400, and 6.6% by volume of the spermicide known as Nonoxynol-9 which has the chemical name nonylphenoxypolyethoxyethanol. The foregoing materials are available from Union Carbide Corporation under the trade names Carbowax 3350, Carbowax 400, and Tergitol NP-9, respectively. The foregoing mixture provides a suitable ointment form for application of the first lubricant 32. The spermicide may range from 2-10% by volume of the mixture of the first material, preferably between about 6.1% and 7.18 by volume, and most preferably about 6.6% by volume. The quantity of the first material 32 that is applied to the sheath ranges from about 0.3 gram to about 0.6 gram, preferably between 0.35 gram and 0.55 gram, and most preferably about 0.45 gram. By way of example, the lubricant 34 may be a silicone fluid comprising dimethylpolysiloxane fluid containing a predetermined quantity of a spermicide such a Nonoxynol-9. The volume of Nonoxynol may range from 2-10%, preferably between about 6.1% and 7.1%, and most preferably about 6.6%. The quantity of the lubricant may range from 0.3 to 0.6 gram, preferably between about 0.35 gram and 0.55 gram, and most preferably about 0.45 gram. In order for the lubricant to spread about the surfaces of the sheath, it has a viscosity between about 50-500 centistokes, preferably about 200 centistokes. When the preferred range of between about 6.1% and 7.18 by volume of the two spermicide-containing compositions are used, with the compositions each being in the preferred range of 0.35 gram to 0.55 gram, the quantity of spermicide in each compositions ranges from about 21.35 mg to about 39.05 mg. The spermicide becomes diluted by vaginal fluids. Accordingly, the foregoing range for the amount of spermicide is greater than the quantity required for killing the sperm, and it has been found that effectiveness can be obtained with lesser amounts of spermicide, such as 10 mg. An advantage in providing spermicide on the outside surface of the sheath is that the spermicide is spread about the vagina during intercourse and is available to kill sperm should the sheath rupture or otherwise fail. An extra measure of effectiveness is thereby provided. The primary means for killing sperm, however, is by providing a relatively large quantity of spermicide at the closed end of the sheath, where the spermicide is available to directly contact the sperm when it originally is provided by the male organ. In many instances, the first lubricant inside the sheath is all that is required to prevent conception if the sheath ruptures or otherwise fails. From the foregoing, it will be observed that numerous variations and modifications may be affected without departing from the true spirit and scope of the novel concept of the invention. It is to be understood that no limitation with respect to the specified device illustrated herein and the method described herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims: CLAIMS 1. A spermicidal contraceptive sheath, comprising a contraceptive sheath having a closed end and an open end, said sheath having an outside surface and an inside surface, said contraceptive sheath being provided with a spermicide-containing material characterized in that a first spermicide-containing material is provided on said inside surface of the closed end of said sheath, said first material having a sufficiently high coefficient of friction to retain said first material on said inside surface of said sheath, and a spermicide-containing lubricant is provided on said outside surface of said sheath, whereby a first dosage of spermicide is available within said sheath and a second dosage of spermicide is available outside said sheath. 2. A contraceptive sheath as defined in claim 1, characterized in that said first material is in a solid or semi-solid form. 3. A contraceptive sheath as defined in any one of the preceding claims, said first material is contained substantially within said closed end of said sheath. 4. A contraceptive sheath as defined in any one of the preceding claims, characterized in that said lubricant has a sufficiently low coefficient of friction to spread by means of capillary action to both said inside surface and said outside surface of said sheath. 5. A contraceptive sheath as defined in any one of the preceding claims, characterized in that said first material is a solid or semi-solid comprising polyethylene glycol containing between 6.1% and 7.1% by volume of nonylphenoxypolyethoxyethanol. 6. A contraceptive sheath as defined in claim 6, between about .35 gram and about .55 gram of said first material is provided in said sheath. 7. A contraceptive sheath as defined in any one of the preceding claims, characterized in that said lubricant comprises a silicone fluid containing between about 6.1% and about 7.1% by volume of nonylphenoxypolyethoxyethanol. 8. A contraceptive sheath as defined in claim 7, wherein said silicone liquid comprises dimethylpolysiloxane. 9. A contraceptive sheath as defined in claim 7 or 8, characterized in that between about 0.35 gram and about 0.55 gram of said lubricant is provided on said sheath. 10. A spermicidal contraceptive sheath, comprising a contraceptive sheath of latex rubber material having a closed end and an open end, said sheath having an outside surface and an inside surface, said contraceptive sheath being provided with a spermicidal-containingmaterisl charactertzed in that a spermicide-containing material is provided on said inside surface of said closed end of said sheath, said material being a semi-solid or solid material that is disposed substantially within said closed end of said sheath, whereby a dosage of spermicide is available within said sheath. 11. A spermicidal contraceptive sheath as defined in claim 10, wherein said first lubricant contains at least 10 mg. of spermicide in said closed end. 12. A method of manufacturing a spermicidal contraceptive sheath, characterized by the steps of providing a contraceptive sheath having a closed end and an open end, an outside surface and an inside surface, applying a first spermicide-containing material on the inside surface of the closed end of the sheath, applying a spermicide-containing lubricant on said sheath, spreading said lubricant about the outside surface of said sheath, thereby providing one dosage of spermicide within said sheath and another dosage of spermicide outside said sheath.

Inventors: PUGH, BRADLEY LAVELLE
Applicants: ANSELL INCORPORATED
Application year: 1982
Main classification: A61F5
IPC codes: A61F6