"CONDOM AND PROCEDURE"

[0001] The present invention relates to a contraceptive device, and a method for manufacturing a contraceptive device .

[0002] Condoms are an important resource for preventing the transfer of sexually transmitted diseases, and to curb the spread of such diseases, even before carrying out an effective contraceptive function.

[0003] It is known that substances capable of giving pleasant sensations during coitus may be added to condoms .

[0004] Purely by way of example, the lubricant could be enhanced with stimulating substances suitable for generating heat in contact with the vaginal mucosa, or with retarding or anesthetic substances to delay the man's climax of the sexual act.

[0005] Nevertheless, to date, the condom has not been thought of as an applicator, or as a means of administration of drugs or substances beneficial to the bodies of men or women.

[0006] The present invention falls within the previous context, proposing to provide a contraceptive device which, in addition to performing the traditional barrier function (with respect to bodily fluids and transmissible diseases), comprises at least one natural and medical active ingredient capable of being transferred during coitus, and may relieve the symptoms of migraine or headache .

[0007] According to a further innovative aspect, the present invention provides a contraceptive device which, in addition to performing the traditional barrier function, comprises at least one natural immunostimulatory substance capable of being transferred during coitus. These objectives are achieved by means of a contraceptive device according to claim 1, or by means of a contraceptive device according to claim 13, and by means of a manufacturing process according to claim 14. The claims dependent thereon show preferred or advantageous embodiments.

[0008] The aforementioned objectives are is achieved by means of a contraceptive device comprising a condom comprising a condom wall, made of elastic material and defining an inner compartment (specifically: for accommodating a male member) , a lubricant at least partially covering a surface of the condom wall, and at least one essential oil associated with the lubricant.

[0009] According to one embodiment, this device is used in the treatment of migraine or other forms of headache.

[0010] According to such variant, the essential oil therefore advantageously performs the function of active ingredient in the aforesaid treatment.

[0011] It should be noted that, within this description, the term "essential oil" means a product obtained by extraction from aromatic plant material, that is to say scented or rich in "essences".

[0012] Purely by way of example, an essential oil could be obtained by distillation or by pressing from a single type of plant, of which it retains features such as flavor, smell and beneficial characteristics.

[0013] According to one embodiment, the essential oil is mixed with the lubricant.

[0014] According to one embodiment, the essential oil and the lubricant are mixed in a single phase.

[0015] According to one embodiment, the essential oil is suspended in the lubricant.

[0016] According to one embodiment, the essential oil is of plant origin.

[0017] According to one embodiment, the essential oil is selected from the group consisting of essential oil of chamomile, mint, eucalyptus, rose, lavender, juniper, basil, lime tree, thyme and mixtures thereof.

[0018] According to one embodiment, the lubricant at least partly covers an inner surface facing said chamber, and/or an outer surface of said wall, facing in the opposite direction to the inner chamber.

[0019] According to different embodiments, the condom is a male condom or a female condom.

[0020] According to one embodiment, the condom wall is made at least partially (for example completely) of latex.

[0021] According to one embodiment, the condom wall is made at least partially (for example completely) of polyurethane or polyisoprene .

[0022] According to one embodiment, the thickness of the condom wall is in the range of 0.02 to 0.1 mm.

[0023] According to one embodiment, the device comprises at least one further essential oil, mixed with the lubricant, selected from the group consisting of essential oil of tea tree, laurel, ahibero, jasmine, mallow, calendula, camphor, borage, sweet almonds, oats, rhatany, uncaria tormentosa, echinacea, melaleuca, and mixtures thereof.

[0024] According to one embodiment, the further essential oil is mixed with the lubricant.

[0025] According to one embodiment, the further essential oil and the lubricant are mixed in a single phase.

[0026] According to one embodiment, the further essential oil is suspended in the lubricant.

[0027] According to one embodiment, the device comprises shark liver oil mixed with the lubricant. [0028] According to one embodiment, the shark liver oil is mixed with the lubricant.

[0029] According to one embodiment, the shark liver oil and the lubricant are mixed in a single phase.

[0030] According to one embodiment, the shark liver oil is suspended in the lubricant.

[0031] According to one embodiment, the essential oil or the mixture of oils is present in a percentage by weight in the range of 0.3-10.0% wt with respect to the weight of the lubricant, preferably in a percentage by weight in the range 0.5-3.5% wt .

[0032] It should be noted that, within the present description, the expression "mixture of oils" may mean, according to different variants, a mixture of essential oils, or a mixture of at least one essential oil and shark liver oil.

[0033] According to one embodiment, the device comprises a soluble excipient configured to delay the release of the essential oil (or the mixture of oils) at the use of such device.

[0034] In other words, the soluble excipient is used to modulate the release of the essential oil, and in particular to slow down the release of oil to the body tissues (male or female) , so as to guarantee a sufficiently long absorption time of the latter. [0035] According to one embodiment, the soluble excipient is mixed with the essential oil or the oil mixture.

[0036] According to one embodiment, the soluble excipient is mixed with the lubricant.

[0037] According to one embodiment, the soluble excipient coats or at least partially covers the essential oil or the oil mixture.

[0038] According to one embodiment, the essential oil or the oil mixture is micro-encapsulated in the soluble excipient .

[0039] According to one embodiment, the soluble excipient is selected from the group consisting of glycerin, glycerol gelatin, one or more polyethylene glycols and mixtures thereof.

[0040] The previous objectives are also achieved through an immunostimulatory contraceptive device which comprises: a) a condom comprising a condom wall, made of elastic material and delimiting an inner compartment; b) a lubricant at least partially covering a surface of the condom wall; c) at least one immunostimulatory substance, associated or mixed with the lubricant, comprising or consisting of shark liver oil.

[0041] According to one embodiment provided by way of example, such device could comprise - in addition to the immunostimulatory substance - at least one essential oil (for example of plant origin) associated or mixed with the lubricant.

[0042] For example, such essential oil may be present as an active ingredient in the treatment of migraine or other forms of headache.

[0043] According to one embodiment, the essential oil could be selected from the group consisting of essential oil of chamomile, mint, eucalyptus, rose, lavender, juniper, basil, lime, thyme, tea tree, laurel, ahibero, jasmine, mallow, calendula, camphor, borage, sweet almonds, oats, rhatany, uncaria tormentosa, echinacea, melaleuca, and mixtures thereof.

[0044] As regards the preferred or advantageous features of this contraceptive device with the immunostimulatory substance, reference is made to the preceding description .

[0045] The present invention also relates to a method for manufacturing a contraceptive device.

[0046] Since a preferred embodiment provides that this method is aimed at obtaining one of the devices just illustrated, such a method may comprise all the features deducible - even implicitly - from the foregoing description .

[0047] Such method comprises the steps of:

[0048] i) dipping a condom mold in a solution of an elastic material ;

[0049] ii) solidifying the solution on the mold to obtain a condom wall made from said elastic material and delimiting an inner chamber;

[0050] iii) rolling up the condom wall, turning it back spirally from a free annular edge towards a tip of said wall ;

[0051] iv) housing the product of step iii) in a sterile casing;

[0052] v) introducing a lubricant in the sterile casing, so that such substance covers at least partially a surface of the condom wall, and associating with the lubricant at least one immunostimulatory substance comprising or consisting of shark liver oil, or at least one essential oil as an active ingredient in the treatment of migraine or other headaches, so as to obtain the aforesaid device;

[0053] vi) optionally sealing the sterile casing.

[0054] According to one embodiment, step iii) comprises a step of turning up the free annular edge towards the outside of the compartment, so as to roll the aforesaid wall on itself up to the tip.

[0055] According to one embodiment, between steps ii) and iii) a step is provided to remove the condom wall from the condom mold.

[0056] According to one embodiment, the step v) is preceded by a step of mixing the essential oil or the shark liver oil and the lubricant in a single phase.

[0057] Therefore, according to such variant, in step v) the substep of associating precedes advantageously the substep of introducing.

[0058] In other words, according to one embodiment, step v) could comprise a first substep of mixing the essential oil (or shark liver oil) and the lubricant, and a subsequent second substep of introducing the lubricant and the essential oil (or shark liver oil) into the sterile envelope, for example substantially at the same time .

[0059] According to one embodiment, before step iii) , the process could comprise a step of covering the products of step ii) with an anti-adhesive substance so as to reduce or eliminate the capacity of the condom wall to adhere to itself (when folded or rolled up) , or to adhere to condom walls of other condoms.

[0060] With regard to such step, following a removal of the condom walls from their molds, the covering step could comprise a step of tumbling the condom walls in the anti- adhesive substance.

[0061] According to one embodiment, the anti-adhesive substance could be in powder form.

[0062] According to one embodiment, the anti-adhesive substance could be or could comprise talc.

[0063] Innovatively, the device and the method object of the present invention allow the drawbacks related to the prior art to be brilliantly resolved.

[0064] More precisely, the described method and device allow pleasant sensations of coitus to be combined with the usefulness of applying a medication or a beneficial substance .

[0065] Advantageously, the method and the device object of the present invention allow a condom to be provided that may be used in the treatment of a series of different conditions or pathologies such as, for example, Candida, herpes simplex, genital warts, cystitis, urethritis, stress, insomnia, irritable bowel, common germs, hypertension, decreased libido, female hormonal disorders, menstrual pain, nausea, colitis, sinusitis, rhinitis, anxiety, bronchitis, cough, asthma, back pain, muscle aches, tachycardia, colds, inflammation, diabetes, burns, eczema, allergic symptoms, halitosis, vaginal dryness, redness of the vaginal walls, vaginal itching, anal itching, and similar.

[0066] Advantageously, the method and the device object of the present invention allow a condom to be provided with an immunostimulatory function, not only due to the alkylglycerols contained therein. [0067] Advantageously, the oils described above are - per se - capable of performing a lubricating action.

[0068] Advantageously, the method object of the present invention allows it to be implemented in any existing production line, with extremely reduced investment costs.

[0069] Advantageously, the method and the device object of the present invention allow the aromas and fragrances currently used in many types of condoms to be abandoned, for example to eliminate the smell of the condom material or to impart particular smells, perfumes and/or flavors. In effect, the essential oil performs the dual function of condom lubricant and fragrance by virtue of its own pleasant scent.

[0070] To the embodiments of said method and the aforesaid devices, one skilled in the art, in order to meet specific needs, may make variants or substitutions of elements with others that are functionally equivalent.

[0071] Also these variants are contained within the scope of protection as defined by the following claims.

[0072] Furthermore, each variant described as belonging to a possible embodiment may be achieved independently of the other variants described.