GB1595711A

GB1595711A - Male contraceptive devices

Info

Publication number: GB1595711A
Application number: GB1095077A
Authority: GB
Original assignee: Individual
Current assignee: Individual
Priority date: 1978-03-02
Filing date: 1978-03-02
Publication date: 1981-08-19

Description

(54) IMPROVEMENTS IN OR RELATING TO MALE CONTRACEPTIVE DEVICES (71) I, ERNEST FRANKLIN a British subject of 10 Nuneham Square, Abingdon Oxfordshire OX14 IEH do hereby declare the invention, for which I pray that a patent may be granted to me, and the method by which it is to be performed, to be particu marly described in and by the following statement: This invention relates to male contraceptive devices.

There are very strong reasons for requiring an improved male method of contraception. Fifteen years after the introduction of the contraceptive Pill it is still used by only about 2()% ot the total number of people requiring contraception, and this proportlon shows very little tendency to increase further, presumably, due to actual or feared side effects.

Recent surveys indicate that about 28% of people still use the contraceptive sheath and most consider it unsatisfactory from the point of view of reduced and unnatural sensations. About 14% use withdrawai, which apart from being very undesirable aesthetically and psychologically, is also very unreliable. Thus about 42% are so committed to a male method that they are prepared to use two very unsatisfactory ones. It seems very likely that, if a more satisfactory male method became available, it could very well be adopted by a large proportion of this 42% and probably also by some of the users of other methods.

Organisations such as the Family Planning Association and the Simon Population Trust have expressed the view that a better male method is badly needed, because of the tendency, particularly by young girls, to claim the fact that the Pill is being used, when, in fact, it is not.

According to the present invention there is provided a male contraceptive device comprising an envelop of flexible impermeable material, the envelop having a flange portion generally of conical or domed shape so as to fit the glans penis and a teat portion extending from the flange portion for collecting semen, a medically acceptable adhesive applied to the inside surface of the flange portion for attaching the flange portion to the glans penis, and an applicator means detachably holding the flange portion at least partially inside out for assisting the attaching of the flange portion to the glans penis.

The expression "at least partially inside out", as used herein, covers any device in which the flange portion is flexed hack on itself; for example, the flange may be held stretched across an opening through the applicator means to such an extent that the flange portion assumes a generally flat form.

The adhesive is provided on the inside surface of the envelope in the vinicity of the opening. If desired the adhesive may incorporate a stimulant for increasing sensitivity of the glans penis.

The adhesive is preferably one that reduces its adhesion on application of a releasing agent of solvent for the adhesive for the purpose of removing the envelope from the glans penis.

A thin strip of flexible material or a thin perforated diaphragm may be provided across the opening of the teat portion to serve as a means for retaining semen in the teat portion.

The general principle of an adhesive contraceptive device which is the subject of this invention appears, at first sight, to be a very simple one and it may seem surprising that it has not been used before. However, the actual use of such a principle is much more difficult than it may seem to be. The envelope is made of some thin, soft and flexible material, such as rubber of similar consistency and thickness to that of conventional sheaths. Contraceptive devices according to the present invention will therefore be small, affected by static electricity, and a part of the device is coated with a strong adhesive, and will therefore be extremely difficult to handle. The applicator means does however assist in the handling and attachment of the contraceptive to the glans penis.

The applicator means may constitute part of a packaging means.

A line of weakness such as for example perforations, an adhesive joint, or a region of the envelope that is thinner than the remainder of the envelope wall, is provided between the envelope and the applicator means, along which the applicator means may be detached from the envelope.

Preferably the applicator means comprises a hollow cylindrical member and the flange portion of the envelope is attached to the cylindrical member. The hollow cylindrical member may be open at one or both ends. Detachable caps, for example foil discs, may be provided to close off the otherwise open ends of the hollow cylindrical member.

Provision must also be made for keeping the adhesive out of contact with other surfaces of the contraceptive during packaging and storage. However, since the device would probably be employed as a "use once and throw away" device, it must be simple and cheap to make, in addition to being easy to use. 1'herefore the applicator means is detachably mounted in an outer protective casing. The outer protective casing is preferably a hollow tubular member open at both ends. Detachable caps, for example foil discs, may be provided to close off the otherwise open ends of the hollow tubular member.

A plurality of contraceptive devices constructed in accordance with the present invention may be assembled together so that adjacent applicator means, or protective casings of each contraceptive device cooperate to form a packaging means for the contraceptive devices.

It will be seen that the contraceptive device of the present invention performs the same function as the well known conventional full length contraceptive sheath, but avoids the great disadvantage of covering virtually the whole of the penis. The contraceptive device of the present invention thus covers only a small fraction of the area of the glans penis.

Embodiments of the present invention, will now be described, by way of examples only, with reference to the accompanying drawings in which Figure 1 illustrates a contraceptive device constructed according to the present invention, Figure 2 shows the contraceptive device of figure 1 attached to a detachable applicator means, Figure 3 illustrates the method of attaching the contraceptive device shown in Figure 2 to a penis.

Figure 4 illustrates a contraceptive device as shown in figure 1 attached to a second type of applicator means.

Figure 5 illustrates a contraceptive device as shown in Figure 1 attached to an applicator in the form of a cylindrical member, which is itself detachably mounted in an outer protective casing.

Figure 6 illustrates a contraceptive device as shown in Figure 1 attached to a futher type af applicator means. and Figures 7 and 8 show a method of attaching the contraceptive device of Figure 6 to a penis.

Referring to Figure 1 the contraceptive device comprises an envelope 10 made of thin flexible fluid - impermeable material, such as, for example, rubber having an opening 11 for receiving the tip of a penis.

The envelope 10 has a teat portion 12 for collection semen and a flange portion 13 formed into the shape of a cone or dome so that it can be fitted to the shape of a glans penis approximately.

The inner surface of the flange portion 13, in the vicinity of the opening for receiving the tip of the penis, is coated with a medical adhesive 15 which is suitable for attaching the contraceptive device to the glans penis. The most satisfactory type of adhesive found for this purpose is the type used on aerated waterproof bandages, medicaldressings, or strappings, of the type sold under the Registered Trade Marks, Band Aid, Air Strip and Elastoplast. Other adhesives may also be suitable.

Referring to Figure 2 the contraceptive device of Figure 1 is attached to a detachable applicator means 16 which is in the form of a hollow cylindrical member, or ring, 17 made of material such as plastics, stiff paper or cardboard. The flange portion 13 is stretched across the ring 17 and the envelope 10 is attached to the ring along its edge by an adhesive 18 which is sufficiently strong to withstand the force of contraction of the rubber of the flange 13 but not so strong as to prevent manual detachment of the ring 17 after application of the contraceptive to the glans penis as described below. A suitable adhesive for this purpose is, for example, a thin glue consisting of gelatin and water, preferably in the ratio of 1 part gelatin to 4 parts water. Other glues or adhesives may be used instead of gelatin and water. The ring 17 which of course, may have a wide variety of shapes serves to facilitate attachment of the contraceptive to the glans penis and may also provide a convenient packaging and storage container for the contraceptive.

Stretching of the flange 13 for attachment to the ring 17 can probably best be carried out by provision of an extension to the flange (not shown) which is so formed that it can be stretched over a suitable former (not shown) or gripped with a clamping device.

(not shown). This flange extension is cut away after the flange 13 has been fixed to the ring 17.

Referring to Figure 3 the contraceptive is applied to the glans penis in the following way: The ring 17 is held between say the thumb and second finger, whilst the first finger is used to press the teat 12 flat so as to expel air. The flange 13 is then pressed onto the glans penis 19 by moving down the ring 17 with the centre of the collapsed teat 12 over the meatus. As the ring 17 is pressed down further, the rubber flange 13 stretches into a dome shape and the glans adopts a flatter shape so that they run together without creasing of the rubber or the skin.

When the situation shown in Figure 3 (c) is reached, the edge of the rubber flange 13 is detached from the ring 17 by breaking the adhesive connection 18 all round with a finger, as shown in Fig. 3 (d). The device is then left adhesively attached to the glans, in a leak proof manner as shown in Fig. 3 (e).

Instead of detaching the flange 13 from the ring 17 by breaking the adhesive connection 18, a line of weakness may be provided between the contraceptive device and the ring 17.

The line of weakness may be in the form of perforations or thinning of the material of the flange 13 at a suitable radius, so that it will tear away when the ring 17 is pressed down over the glans. The adhesive connection between the ring 17 and the envelope 10 does not then need to be easily breakable and stronger glues than gelatin and water could be used.

Detachment of the contraceptive device of Figures 1 and 2 after use can be done by making use of the fact that there are a number of liquids which can safely be applied to the skin, which, though not good solvents for the type of adhesive used, do, nevertheless, act as very effective agents for releasing the adhesive from the skin. Examples of these are, (when using adhesives such as are used on dressings or bandages sold under the Elastoplast, Band Aid or Air Strip Trade Marks) Surgical spirit, industrial spirit, ethyl alcohol, isopropyl alcohol, etc.

A small syringe, or deformable container such as a squeezable bottle, satchet, or capsule, fitted with a nozzle which is preferably soft and deformable, may be filled with one of these liquids. The edge of the rubber flange 13 can easily be lifted off the glans by pressing the nozzle against it while expelling some of the liquid. The remainder of the flange 13 may be eased off the glans penis whilst applying more liquid as required. It will generally be found that this procedure leaves a small residue of adhesive on the skin, but this can easily be removed by means of a small pad of cotton wool soaked in the liquid.

As an alternative to the syringe or deformable container, a small brush or spill wetted with a suitable releasing agent or solvent has been found to work quite satisfactorily. The liquids may be solvents for the adhesive used or a release agent which is effective to reduce the adhesion of the adhesive.

There are many ways in which the contraceptive device of Figure 1 could satisfactorily be packaged and Fig. 4 and 5 show examples of such ways.

Referring to Figure 4 the ring 17 to which the flange 13 is attached is made as a simple flat ring to facilitate manufacturing processes, such as trimming the edge of the flange 13. This ring 17 is then attached by adhesive, for example, to the internal flange 20 of an outer protective casing 21 in the form of a tubular member whose ends are closed bv aluminium foil discs 22.

In Fig. 5, the ring 17 is again made as a simple flat ring which is attached to a second ring 23 located loosely in an outer protective casing 24 in the form of a tubular member effectively closed off at one end and open at the other. An aluminium disc 22 may be provided to blank off the open end of the casing 24.

Assemblies such as shown in Figs. 4 and 5 can be stacked in outer containers (not shown) with or without their individual closing discs 22 although in the case of Fig. 4 it would be necessary to provide separators to prevent the teat 12 of one device from coming into contact with the adhesive layer 15 on the flange of the next. Each individual pack may incorporate a disposable sachet or capsule of releasing agent or solvent for removing the contraceptive from the glans penis.

Referring to Figure 6 the applicator means is in the form of a hollow domeshaped rubber former 25. The outer surface of the envelope 10 in the vicinity of the opening of the envelope is stuck by a suitable adhesive to the convex side of the former 25. An adhesive 15 for securing the envelope 10 to the glans penis is applied to the inner surface of the envelope 10 in the vicinity of the opening 11 and the former 25 is flexible enough to permit it to be turned inside-out to bring the adhesive 15 into contact with the glans penis as shown in Figure 7. The rubber former 25 is provided with a slit 26 to facilitate removal of the former once the contraceptive is in place on the glans. The former 25 constitutes an applicator means.

If desired a thin strip 27 of flexible material such as for example rubber, (see Fig. 1) or a thin perforated rubber diaphragm may be provided across the opening of the teat portion 12 to serve as a means for retaining semen in the teat portion. The strip 27 also serves to reduce unatural feelings due to creases in the teat portion 12 pressing against the sensitive skin around the meatus.

The term "envelope" used herein is taken to refer to a receptacle made of flexible material which when adhesively fixed to the glans penis forms a fluid-tight bag or container for retaining semen.

An alternative method of attaching the contraceptive device of Figure 1 to the glans penis is to attach the edge of the flange 13 to a hollow cylindrical member 17 of sufficiently small diameter as not to stretch the flange appreciably. If the open end of the cylindrical member 17 is closed off and the space within the cylindrical member slightly pressurised, the contraceptive device may be inflated inside-out to approximately its natural shape in reverse so that the adhesive 15 is held out of contact with itself. The contraceptive device can now be rolled on to the glans penis in a manner similar to that shown in Figure 7, but without the former 25. When the rolling on process is completed, the flange 13 is detached from the ring 1 7 by one of the methods described previously. With this alternative method of attachment, the contraceptive device can be stored either inflated or drawn fully into the cylindrical member 17. In the latter case there would preferably be a means for bringing about inflation prior to attachment to the glans penis such as a flexible bulb, squeeze-bottle or membrane. In the former case there would preferably be an outer protective casing to keep the adhesive out of contact with other surfaces and a means for releasing the pressurisation such as a hole with an adhesive tape cover during attachment to the glans.

It has been found that the adhesion of some types of adhesive 15 to the flange 13 can be anhanced by etching the surface of the flange 13. A suitable etching agent is, for example, concentrated sulphuric acid, but there may be other etching agents which are more convenient for large scale production.

WHAT I CLAIM IS: 1. A male contraceptive device comprising an envelope of flexible impermeable material, the envelope having a flange portion generally of conical or domed shape so as to fit the glans penis and a teat portion extending from the flange portion for collecting semen, a medically acceptable adhesive applied to the inside surface of the flange portion for attaching the flange portion to the glans penis, and an applicator means detachably holding the flange portion at least partially inside out for assisting the attaching of the flange portion to the glans penis.

2. A contraceptive device as claimed in Claim 1, wherein the flange portion is held stretched across an opening through the applicator means to an extent such that the flange portion assumes a generally flat form.

3. A contraceptive device as claimed in Claim 1, wherein the applicator means is of similar shape to the flange portion and of flexible material so as to be capable of being turned inside-out, the outside of the flange portion being detachably attached to the outside of the applicator means so that by turning the applicator means inside out the inside surface of the flange portion can be brought into contact with the glans penis.

4. A contraceptive device as claimed in any one of the preceding claims, including a casing in which the applicator means is detachably mounted for protccting the envelope.

5. A contraceptive device as claimed in any one of the preceding claims, wherein the adhesive is one that reduces its adhesion on the application of a releasing agent.

6. A contraceptive device as claimed in Claim 5, in combination with a container holding a releasing agent in the form of a solvent in which the adhesive is soluble, and to be applied when the envelope is to be detached from the glans penis.

7. A contraceptive device according to any one of the preceding claims wherein a thin strip of flexible material is provided across the opening of the teat portion.

8. A contraceptive device according to any one of claims 1 to 6 wherein a thin perforated diaphragm is provided across the opening of the teat portion to serve as a means for retaining semen in the teat portion.

9. A contraceptive device according to any one of claims 1 to 8 wherein the adhesive incorporates a stimulant for increasing sensitivity of the glans penis.

10. A contraceptive device according to any one of the preceding claims wherein a line of weakness is provided between the flange portion and the applicator means along which the applicator means may be detached from the flange portion.

11. A contraceptive device according to claim 10 wherein the line of weakness is constituted by perforations.

12. A contraceptive device according to claim 10 wherein the line of weakness comprises a region of the flange portion that is thinner than the remainder of the flange portion.

13. A contraceptive device according to claim 10 wherein the line of weakness comprises an adhesive joint between the applicator means and the flange portion.

14. A contraceptive device according to any one of the preceding claims wherein the applicator means constitutes part of a packing means.

15. A contraceptive device according to any one of the preceding claims wherein the applicator means comprises a hollow cylindrical member open at both ends.

16. A contraceptive device according to any one of claims 1 to 14 wherein the

**WARNING** end of DESC field may overlap start of CLMS **.

Claims

**WARNING** start of CLMS field may overlap end of DESC **. material which when adhesively fixed to the glans penis forms a fluid-tight bag or container for retaining semen. An alternative method of attaching the contraceptive device of Figure 1 to the glans penis is to attach the edge of the flange 13 to a hollow cylindrical member 17 of sufficiently small diameter as not to stretch the flange appreciably. If the open end of the cylindrical member 17 is closed off and the space within the cylindrical member slightly pressurised, the contraceptive device may be inflated inside-out to approximately its natural shape in reverse so that the adhesive 15 is held out of contact with itself. The contraceptive device can now be rolled on to the glans penis in a manner similar to that shown in Figure 7, but without the former 25. When the rolling on process is completed, the flange 13 is detached from the ring 1 7 by one of the methods described previously. With this alternative method of attachment, the contraceptive device can be stored either inflated or drawn fully into the cylindrical member 17. In the latter case there would preferably be a means for bringing about inflation prior to attachment to the glans penis such as a flexible bulb, squeeze-bottle or membrane. In the former case there would preferably be an outer protective casing to keep the adhesive out of contact with other surfaces and a means for releasing the pressurisation such as a hole with an adhesive tape cover during attachment to the glans. It has been found that the adhesion of some types of adhesive 15 to the flange 13 can be anhanced by etching the surface of the flange 13. A suitable etching agent is, for example, concentrated sulphuric acid, but there may be other etching agents which are more convenient for large scale production. WHAT I CLAIM IS:

1. A male contraceptive device comprising an envelope of flexible impermeable material, the envelope having a flange portion generally of conical or domed shape so as to fit the glans penis and a teat portion extending from the flange portion for collecting semen, a medically acceptable adhesive applied to the inside surface of the flange portion for attaching the flange portion to the glans penis, and an applicator means detachably holding the flange portion at least partially inside out for assisting the attaching of the flange portion to the glans penis.

16. A contraceptive device according to any one of claims 1 to 14 wherein the

applicator means comprises a hollow cylindrical member which is closed at one end.

17. A contraceptive device according to claim 15 or 16 wherein the, or each, otherwise open end of the hollow cylindrical member is provided with a detachable.

18. A contraceptive device according to claim 4 wherein the outer casing is a hollow tubular member.

19. A contraceptive device according to claim 18 wherein the applicator means is a hollow cylindrical member and is mounted in the bore of the outer easing.

20. A contraceptive device according to claim 18 wherein the hollow tubular member is open at one end.

21. A contraceptive device according to claim 18 wherein the tubular member is open at both ends.

22. A contraceptive device according to claim 20 or claim 21 wherein the, or each, otherwise open end of the tubular member is provided with a detachable cap.

23. A plurality of contraceptive devices as claimed in claim 1 assembled together in a stack in which the applicator means of adjacent contraceptive devices cooperate to form a packaging means for the contraceptive devices.

24. A plurality of contraceptive devices as claimed in Claim 4 assembled together so that the casing of adjacent contraceptive devices cooperate to form a packaging means for the contraceptive devices.

25. A contraceptive device as claimed in any one of the preceding claims, wherein the adhesion of the adhesive to the flange portion has been enhanced by prior etching of the flange portion.

26. A contraceptive device as claimed in Claim 3, wherein a radial slit is provided in the applicator means to facilitate removal of the applicator means once the envelope is in place on the glans penis.

27. A contraceptive device according to Claim 1 or Claim 2, wherein the applicator means comprises a hollow cylindrical member which is pressurizable to inflate the envelope inside out to facilitate attachment to the glans penis.

28. A contraceptive device substantially as hereinbefore described with reference to Fig. 1 to 3e, or Fig. 1 and 4, or Fig. 1 and 5, or Fig. 1, 6, 7 and 8 of the accompanying drawings.