Background of the Invention Contraceptive devices for use by males are conceived in order to prevent conception, on the one hand, and, on the other, preventing diseases that are communicated through sexual intercourse. This last function has acquired particular importance, since the appearance of AIDS. The known devices, however, do not always carry out the functions to which they are destined in a complete and efficient manner. On the one hand, they are subject to failure; on the other hand, they are difficult to use in case of incomplete erection and, of course, of lack of an erection. Furthermore, they perform no useful function in the case of premature ejaculation.

It is a purpose of this invention to overcome these drawbacks and to provide a device for use by males in sexual intercourse which, in its various embodiments, is capable of preventing conception, overcoming the effects of early ejaculation and overcoming problems due to impotence or insufficient potency.

It is another purpose of this invention to provide such a device which comprises several embodiments, each of which is adapted to obtain a particular effect.

It is a further purpose of this invention to provide such a device which is extremely easy to use.

It is a still further purpose of this invention to provide such a device which is simple and economical.

It is a still further purpose of this invention to provide such a device the basic structure of which is the same in all the aforesaid embodiments, whereby its manufacture can be standardized.

Other purposes and advantages of the invention will appear as the description proceeds.

Summarv of the Invention The hygienic device according to the invention is characterized in that it comprises an essentially tubular body which is easily deformable and has means for introducing into it gas under pressure to bring it into substantially distended condition and means for discharging said gas - said body, when brought to said substantially distended condition and not deformed by contact with any other bodies, having an intermediate, substantially cylindrical outer surface, bounded by semi-toroidal end portions, and an axial channel. The expression "essentially tubular body" is used herein because said body is defined by a) a cylindrical outer surface, and b) an inner surface, which is the surface of said axial channel, which is also substantially cylindrical and coaxial with the outer surface. As is well known, the term "torus" describes a solid or surface generated by the rotation of a circle about an axis that does not intersect it. The term "semi-toroidal" means herein a body or surface that is one-half of a torus which has been cut along its plane of symmetry. The essentially tubular body, which will also be called hereinafter "sheath", for brevity's sake, may be, and generally is, easily deformed in use, as will be better explained hereinafter, in particular by external and/or internal contact with other bodies, and more particularly, the tubular, axial space may be dilated in part, the semi-toroidal end portions may be deformed to approach frusto-conical portions or in other ways, and its cylindrical portion between said ends may be creased or otherwise deformed, said deformations causing the sheath to depart from the shape defined by the expressions hereinbefore used. It may be said that the above expressions define the ideal shape of the body in its distended condition.

Because of its structure, said sheath according to the invention can advance along a canal or duct as its toroidal end portions roll over the inner surface of the canal or duct and may also slide over said inner surface to a greater or lesser extent. In this motion, while the overall shape of the device remains essentially unchanged, any specific segment of the sheath will successively occupy different positions, e.g., a segment which constitutes a semi-toroidal end portion may become a part of the intermediate, substantially cylindrical portion, and vice versa.

In an embodiment of the invention, the axial channel is sealed at, or at a short distance beyond, its proximate end. By the expression "proximate end", without further specification, is meant herein the end that is closer to the male user at the beginning of the sexual act. Thereafter, since the sheath rolls over itself, the channel seal will approach the opposite end of the sheath.

By the expression "distal end", without further specification, is meant herein the end that is farther from the male user at the beginning of the sexual act.

The expressions "actual proximate end "actual distal end", used hereinafter, will indicate, respectively, the end nearer to and the end farther from the male user at the climax of the sexual act.

In another form of the invention, the sheath is additionally complemented with a removably, rigid or at least stiff sleeve, which is placed around the base of the male sexual organ to facilitate the introduction of this latter into the sheath when said sheath is in a collapsed condition, as hereinafter better explained, and is removed after said introduction. The sheath itself is as hereinbefore defined and this variant too has two embodiments, inasmuch as the axial channel may be open or sealed.

The hygienic device according to the invention is used by introducing the penis into the proximate end of the axial channel of the device, and admitting gas, generally air, under moderate pressure into the sheath, thereby distending it. After the climax of the sexual act, the air may be discharged, at least in part, to facilitate withdrawal.

The sheath according to the invention can be prepared, e.g., by providing a thin, flexible plastic tube, folding the same over itself so that one segment thereof is placed inside the other segment, and can be called "the inner segment", and juxtaposing and joining the two ends of said tube. In an embodiment of the invention the tube has a restricted cross-section at such a point that it will be located, in the completed sheath, far from the gas inlet.

Then invention also provides a method for overcoming impotence or insufficient potency, which comprises: a- providing a sheath which is an essentially tubular body, which sheath is easily deformable and has means for introducing into it gas under pressure to bring it into substantially distended condition and means for discharging said gas - said sheath, when brought to said substantially distended condition and not deformed by contact with any other bodies, having an intermediate, substantially cylindrical outer surface, bounded by semi-toroidal end portions, and a tubular, empty axial channel; b - providing a sleeve for receiving and supporting the sheath in its collapsed condition, said sleeve being rigid or at least stiff and of such a diameter as to fit over the user's sexual organ prior to the sexual act; c- fitting said sheath in collapsed condition over said sleeve; d - fitting said sleeve with said sheath over the male organ; and e - admitting gas under pressure to bring said sheath to said substantially distended condition.

Brief Description of the Drawings In the drawings: - Fig. 1 schematically illustrates, in axial cross-section, a device according to an embodiment of the invention, in its distended condition, Figs.

1A and 1B illustrating, at an enlarged scale, two variants of a detail of the device; - Figs. 2 to 4 illustrate in the same way the same embodiment in various stages of its use; - Fig. 5 illustrates in axial cross-section a device according to another embodiment of the invention, in a collapsed condition, prior to its use; - Figs. 6 to 8 illustrate, also in axial cross-section, the embodiment of Fig. 5, in various stages of its use; and - Figs. 9 to 11 illustrate, also in axial cross-section, various stages of the preparation of the device of Figs. 5 to 8.

- Figs. 12 and 13 illustrate, in axial cross section another possible use of the device.

Detailed Description of Preferred Embodiments A device according to the first embodiment of the invention is shown in Fig. 1 in its distended condition, before its use. The sheath is generally indicated at 10, and it is seen that it has an outer surface that is in part cylindrical and which has two semi-toroidal surfaces 11 and 12 that are respectively at the distal and the proximate end. The device has an axial channel 14, which is open in one variant (Fig. 1A) and closed by a seal 22 in another variant (Fig.

1B) at its proximate end. A gas channel 16 is attached to the sheath at 17 near its distal end. The gas used is preferably, though not necessarily, air. At its inlet, tube 16 is attached to a source of gas pressure, schematically indicated at 18, which may be conveniently be a hand-operated pump, which may be, e.g., an elastic container, e.g. balloon-shaped, provided with an inlet valve 19 and with an outlet valve 20. While reference will often be made, hereinafter, to "pump" 18, it should be understood that this is not a limitation and that any convenient source of gas pressure could be used, e.g. a small container of gas under pressure, provided with an outlet valve.

Another valve 21 is provided near the inlet 17 of tube 16. Inlet 17 is displaced in the operation of the device, hereinafter described.

The sheath 10 is brought to its distended condition initially by placing inlet tube 16 in communication with the source of gas pressure 18. If the said source 18 is a hand-operated pump, valves 19 and 20 open and close automatically in its operation; in other types of gas pressure sources, they may have to be operated by the user of the device. When a sufficient pressure amount of air has been introduced into the sheath, this latter is brought it to its distended condition of Fig. 1.

Fig. 2 illustrates the device at the beginning of its use by the user. Numeral 25 designates a male sexual organ, the tip of which is introduced into the sheath, which forms a seat 15.

Then, as shown in Fig. 3, organ 25 is pushed all the way inside the device 10 and concurrently, the device is introduced into the vagina, the surface of which is indicated at 26. This causes the device to roll over itself, so that the inlet 17 of conduit 16 that was originally closer to the distal end of the device, shifts to its actual proximate end, while the introduction of organ 25 swells the inner channel 14 to the appropriate dimensions.

In Fig. 4, the device 10 with male organ 25 is partly retracted and its shape is intermediate between those of Figs. 2 and 3.

To free completely the male organ from the sheath according to the invention, valve 21 is open and air is discharged from the inside of the sheath, and this collapses and can easily be extracted.

As all the elements illustrated in the drawings have circular cross-sections, (only air pressure source 18 might, in some cases, not have such a cross- section) no cross-sectional drawings are required to illustrate the device.

In the embodiment of Figs. 5 to 8, which is intended to overcome total impotence, a sheath 30 is provided, which may be identical to that hereinbefore described and be provided with an open inner channel, as in Fig.

1A, or with a sealed inner channel, as in Fig. 1B. The sheath is provided, as in the preceding embodiment, with a inlet tube 31 and a source of air pressure 32, provided with valves 33, 34, the inlet tube 31 being provided with a valve 35. As seen in Fig. 8, sheath 30, when in its descended condition and during the sexual act, has an inner channel 36, corresponding to channel 14 of the embodiments of Figs. 1 to 4.

Sheath 30 is supplemented with an at least stiff sleeve 40, made of a sticky tape, which is only long enough to accommodate the sheath 30 in a collapsed condition, as shown in Figs. 5 and 6. In Fig. 5, the air source or pump 32 is shown as being placed inside sleeve 40, for convenience of packaging, but this position has no functional relevance.

Sleeve 40, as shown in Fig. 6, with the sheath 30 supported on its outside in collapsed and creased condition, is slipped onto the male organ 38, which may be inadequately erected. Then the tape of the sleeve 40 is slipped out and the sheath 30 remains on the male organ 36, near the base of it, as shown in Fig. 7. At this point the sheath 30 is inflated by means of air pressure source or pump 18, and the whole assumes a configuration that is similar to that of Fig. 3, so that the sexual act can be performed.

Figs. 9 to 11 illustrate how a device as illustrated in Figs. 5 to 8 can be manufactured. The manufacturing procedure in general, however, can be used in order to make the device of Fig. 1 as well.

A tube indicated at 40 is folded upon itself, as seen in Fig. 9. The tube is provided with a reduced cross-section 45.

As shown in Fig. 10, end 43 of section 41 is then folded over end 44 of section 42, and finally, as shown in Fig. 11, the two ends are joined, e.g., by welding or by means of adhesive or by any convenient manner. An inlet tube 46 provided with outlet valve 47 and connected to a source of air pressure 48, having inlet valve 49 and outlet valve 50, is connected at 51 to the outer segment of the sheath, near its distal end, far enough from the segment 45. It should be noted that in all the embodiments, the surface of the sheath need not be smooth and can be provided with irregularities, projections, corrugations, and so on, to control the degree of friction during its use. These details can easily be provided by skilled persons and need not be illustrated.

The device is rolling into a duct of any diameter without substantial resistance.

Fig. 12 and 13 illustrate another embodiment of the device, which is equiped with a mantle (numeral 60) covering the head of the penis during different stages of the sexual act. Numerals 16, 18, 25 and 26 have the same meanings as hereinbefore described.

It is seen that in its various embodiments, the device achieves effects that the existing contraceptive devices cannot achieve. Like existing contraceptives, it can be made completely safe against infection and prevent pregnancy when the axial channel, such as 14, is sealed off. However, in addition, it always facilitates the introduction of the male sexual organ into the female sexual organ. In fact, during the introduction, the sheath may be distended to a slightly reduced diameter and its diameter may be increased by increasing air pressure in the sheath. When the axial channel 14 is opened into seat 15, pregnancy is not avoided, but still there is a degree of defense against disease because of the fact that the axial channel is extremely narrow and will be filled at the end with seminal fluid. In case premature ejaculation, the sheath substantially maintains its outer shape and dimensions and permits fully to complete the sexual act. It is apparent that all the embodiments do not differ from one another as to their basic structure, so that the manufacturing stages of the device are essentially the same and the cost of the device can be kept down.

Suitable plastic tubes for making the sheath can have a thickness from 5 to ioo ,um and consist of suitable plastic matter, such as e.g. polyurethane or natural or synthetic rubber. While embodiments of the invention have been described by way of illustration, it will be apparent that the invention can be carried out with many variations, modifications and adaptations, without departing from its spirit or exceeding the scope of the claims.