A Condom

FIELD OF THE INVENTION

The present invention relates to a physiological barrier for use m e g condoms and more particularly to a condom and a method for providing improved feeling for the partners during intercourse when using a condom

BACKGROUND OF THE INVENTION

Due to the growing awareness of the risk of catching sexually transmitted dis¬ eases the defects and problems in connection with the use of condoms has been focused on The use of latex condoms is not fully safe and the users of latex con¬ doms may incur sexually transmitted diseases because of tears and improper use Furthermore, latex condoms may have pores of a size allowing viruses such as HIV to pass through the wall of the condom At the same time, many complain that there is little feeling and consequently sometimes avoid using a condom even when failing to do so could have undesirable consequences or be danger¬ ous To overcome some of the problems it has been proposed to make thinner condoms or to provide the condoms with e g grooves or slots in order to en¬ hance the feeling to give a more natural feeling during intercourse It has also been proposed to provide a sliding portion of the condom for facilitating control- ling a movement of the penis within the condom Furthermore, natural latex con¬ doms may give a risk for some users to develop hypersensitivity against all natural latex products which is a complication of great nuisance to the person in question due to the wide-spread use of natural latex products in the health care management

European patent publication No 0 443 870 A2 discloses a covering material for forming a chemical barrier against harmful agents comprising an outer sheet, an inner sheet and an intermediate layer of flexible material within which is dis¬ persed a chemical barrier substance capable of neutralising the harmful charac¬ teristics of the harmful agents The covering mateπal is stated to be useful as a

glove or condom The covering material disclosed in EP 0 443 870 A2 comprises preferably an internal barrier in a fluid form made up so as to minimise the possi¬ bility that a harmful agent can traverse the covering without contacting the chemi¬ cal barrier in the form of a staggered arrangement of layers Such arrangement will hamper the transmittance of pressure impulses, friction and/or heat

US patent No 4,881,553 discloses a mesh reinforced corftiom having an elastic mesh as an integral part of the walls of the condom which is stated to reinforce the latex walls making the condom less susceptible to breakage without loss of sensitivity The risk of slippage of the condom from the penis during coitus may be reduced if the mesh thread used is slightly thicker than the latex wall or if small slanted projections are formed on the inner wall of the condom By using a thin elastic reinforcing mesh thin condom walls may be obtained in order to en¬ hance the transmission of sensation However, the security against sexually transmitted diseases for such a condom does only match the security of conven- tional latex condoms as there is no extra reinforcement in the areas being open for transmission of sensation (only consisting of the latex wall), and there is no enhanced sensation either

US patent No 4,995,392 discloses a condom of thermoplastic elastomer and polyolefin film having a tubular part and an integral pubic shield The pubic shield may comprise an adhesive secunng the same to the pubic area Such a condom should reduce the risk of sexually transmitted diseases and prevent exposure of the penis and the vagina to infection, especially after ejaculation The condom may have a lubricant on the inner side of the tubular part thereof in order to as¬ sist the user in placing that portion onto his penis Although condoms made of thermoplastic elastomer will show good security against sexually transmitted dis¬ eases, US patent No 4,995,392 is silent with respect to ensuring transmission of sensations over a condom made of thermoplastic elastomer

US patent No 4,869,723 discloses a natural feeling condom and method by al¬ lowing the condom to move, e g by a sliding action on the surface of the penis

during intercourse The condom may comprise a gum-like adhesive agent on the outer side in order to weakly bond the condom to the vagina while tightly holding the condom against the base of the penis, if desired by applying a removable ad¬ hesive to form a tight seal The condom preferably comprises a lubricant on the inner side to enhance the sliding of the penis Sliding of the penis inside the con¬ dom will increase the risk of rupture due to the alternating stretching and com¬ pression of the material if there is a minor failure in the material or a scratch from a nail during application

Thus, there still is a need for a condom which combines security against sexually transmitted diseases such as AIDS, Herpes, Syphilis, Gonorrhoea, Chlamydia and other sexually transmitted diseases with an improved feeling when using a condom rendering the use of condoms more desirable or acceptable

BRIEF DESCRIPTION OF THE INVENTION

It has surprisingly been found that it is possible to provide a condom which com- bines a very high security against sexually transmitted diseases such as AIDS, Herpes, Syphilis, Gonorrhoea, Chlamydia and other sexually transmitted dis¬ eases with an improved feeling during intercourse when using a condom

Thus, the present invention relates to a condom and a method of providing an improved sensibility while using a condom in sexual intercourse, the sensation being different from the sensation using a conventional condom, said condom giving a very high security against sexually transmitted diseases such as AIDS Herpes, Syphilis, Gonorrhoea, Chlamydia and other sexually transmitted dis¬ eases and said condom also being able to transmit and/or enhance sensations and/or stimulation to a degree not seen until now

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be explained more in detail with reference to the drawings in which

Fig. 1 shows schematically a longitudinal section of a condom of the invention being generally cylindrical and having a closed end,

Fig. 2 shows an enlarged view of a section of an embodiment of a condom of the invention,

Fig. 3 shows an enlarged view of a section of another embodiment of the invention, Fig. 4 shows an enlarged view of a section of a third embodiment of a condom of the invention,

Fig. 5 shows an enlarged view of a section of a fourth embodiment of a condom of the invention, and

Fig. 6 shows an enlarged view of a section of a fifth embodiment of a condom of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to a condom, said condom comprising, at least on a part thereof , a physiological barrier material being able to transmit pressure im- pulses, friction and heat, said barrier material comprising a) a first constituent in the form of a physiologically acceptable synthetic polymer, natural polymer and/or modified natural polymer and b) a second constituent in the form of a woven, non-woven or "knitted" material and/or c) a third constituent in the form of fibres and/or particles of a physiologically acceptable material preferably being compatible with the first constituent and the second constituent, if present. The second and optionally third material may inherently be fully or partially compatible with the first material, or they may have been rendered partially or fully compati¬ ble by receiving a treatment before being combined with the first material.

The condom of the invention ensures a better transmission of pressure im- pulses, signals, natural friction and heat.

In one aspect of the invention, the condom may comprise, as the first material, two or more components selected from physiologically acceptable synthetic poly¬ mers, natural polymers and/or modified natural polymers. The constituents may be present in the form of layers, like a laminate, or as domains or patterns of one component in another component.

The first material in the condom of the invention is advantageously a pure poly¬ mer or a mixture or compound of pure polymers giving better opportunity to con¬ trol the properties of the condom and also better opportunity to control the risk of allergenic effects.

In one embodiment of the invention, the condom comprises a mixture of poly¬ mers and fibres, e.g. in the form of a non-woven material made from cotton fibres.

The condom of the invention constitutes a physiological barrier blocking for trans¬ mission of body fluids such as saliva, sperm and/or wound exudates and forms a barrier against transmission of germs such as bacteria or viruses such as HIV or herpes virus.

The first material constitutes a physiological barrier blocking for transmission of body fluids such as saliva, sperm and/or wound exudates and forms a barrier against transmission of germs such as bacteria or viruses such as HIV or herpes virus. At the same time these materials allows for a transmission of sensations to a degree not known hitherto.

One or more of the materials for condoms of the invention may comprise a plasti- cizer and/or extender as the physiologically acceptable synthetic polymer, natural polymer and/or modified natural polymers do not always inherently have a suffi- cient degree of plasticity allowing the use for a condom.

In a preferred aspect of the invention the first material is gel forming The mate¬ rial may inherently be gel forming or this feature may be produced by addition of a plasticizmg agent imparting this property to the material The plasticizer may impart other properties to the first material The first material may be constituted of two or more different gels in the form of layers, like a laminate, or as domains or patterns of one constituent in another constituent The gel may e g be a hy¬ drogel The gel may be a strongly crosslinked gel or may be a liquid gel, prefera¬ bly a viscous gel

In a further preferred aspect of the invention, one of the materials has a fπctional effect or a tack which is enhancing the sensation by giving a better physical con¬ tact between the penis and/or the wall of the vagina

In another aspect, the invention relates to a condom comprising a physiological barrier material being able to transmit pressure impulses, friction and/or heat said barrier material comprising a physiologically acceptable synthetic polymer, natural polymer and/or modified natural polymer showing a high friction and/or affinity to skin When the first material shows adhesive characteristics or a tack the other materials may be omitted without deviating from the gist of the present invention A tack or friction enheigthen the sensations and transmission of pres¬ sure impulses In this embodiment, the physiologically acceptable polymer is preferably a silicone polymer adapting very accurately to the microstructure of the skin enhancing the sensation

Such a condom is preferably prepared from a silicone material combining physio¬ logical tolerability and the desired tack/fπction Condoms only consisting of one silicone material may have a thickness from about 5 μm to about 200 μm more preferred from about 10 μm to about 100 μm and more preferred from about 20 μm to about 80 μm

In a further aspect of the invention, the plasticizer or one of the other compo¬ nents has biological properties such as germicidal, e g bactericidal, anti-viral

effect or other biological effect e g inhibiting or inactivating germs and thus re¬ ducing the risk of transmission of infections or a skin care or healing effect for re¬ ducing local irritation experienced during intercourse The plasticizer may also have a spermicidal effect which is also considered an aspect of the invention Still further, the plasticizer may have a lubricating effect

In accordance with a preferred embodiment of the invention one of the compo¬ nents of a condom of the invention shows a lubricating effect which facilitates the use of the condom without an external lubncant when a lubricant is needed

The condom of the invention preferably has a rigidity and a strength allowing roll- mg of the condom to rolled form being more easy to package, handle and ship and to store for the user

In accordance with another preferred embodiment of the invention one of the surfaces of the condom comprises an anti-blocking surface for enabling rolling and unrolling of the condom

In accordance with a further aspect of the invention, the condom may be loaded with pharmaceutically active compounds e g for treating acute or latent infec¬ tions with e g herpes or Chlamydia, or e g to enhance the sexual power or libido of one or both parties

In one embodiment of the invention the first material the total surface or a part thereof is covered with the barrier material It is envisaged that the barπer mate¬ rial may be present at the inner surface, at the outer surface or on both In an¬ other embodiment, the first material covers the total inner surface of the condom which, in this case may be prepared from the same materials as is conventionally used for the preparation of condoms by methods known per se In another em- bodiment of the invention only the area being in contact with glans during use is covered with the first material Furthermore, the risk that the condom "falls off' after intercourse is reduced and the male partner will not have to withdraw imme¬ diately after ejaculation

In a further embodiment the condom of the invention may have more "first mate¬ rials" and have an adhesive at the part of the condom being adjacent to the shaft of the penis and a barrier material in the area being in contact with glans when using the condom Thus, the best possible safety for sealing and retaining of the condom on the penis is obtained together with safety against viruses passing the condom

The first material may be based on materials conventionally being used for the preparation of condoms or other materials being tailored to the purpose of the present invention

The first material may be a polymer with the following properties, soft, gel-like or may be rendered gel-like using e g plastizicers, and good barrier properties

The first material may be selected from the following list Polysiloxanes, e g Silicone elastomers, polysilanes, polyacrylates and/or polymethacrylates and/or co and/or preferably block copolymers thereof, vinylic polymers and/or co and/or preferably block copolymers thereof, e g copolymers of the Kraton®-type, poly¬ vinyl chloride (plasticized), EVA-types of polymers, latex, neoprene nitnle co¬ polymers containing acrylonitnle and butadiene, polyurethanes, polyesters, polyoxides such as polyvinyl ethers, polymethyl vinyl ether or polytetramethylene oxide (PTMG), polycarbonates, polyamides, polysul- phides, polysulphonates, homo, co or block copolymers of the types exemplified above, as well as polysaccharides including derivatives thereof, polypeptides in¬ cluding derivatives thereof The above list is a listing of materials which are appli¬ cable and may be chosen for the present invention and not to be considered as limiting the invention

In one embodiment, the condom of the invention comprises, at least on a part of the inner and/or outer side, a physiological barrier material being able to transmit pressure impulses, friction and heat, said barrier material comprising one con¬ stituent in the form of a physiologically acceptable synthetic polymer, natural

polymer and/or modified natural polymer, said constituent being in the form of a gel Such gel may be a hydrogel or a hydrophobic gel, according to the desired properties

Plasticizers can be used to soften the polymer Any conventional plasticizer may be used and the choice will depend on the polymer chosen

Lubricating agents may be present at the outer side of the condom and may have a plasticizing effect or the condom may itself form a lubricant in a humid environment

A tackifying resin may be added to the first material or at least a part of the first material may be modified to achieve tackifying properties

The second material has the aim of reinforcing the condom and/or to enhance the sensation When used, this second material imparts strength and structure to the condom The second material may typically be particulate or fibrous When a woven or non-woven material is used it is a demand that the material is suffi¬ ciently elastic and that it has a sufficiently high resistance against tearing The material may typically be a soft polymer or a plasticized polymer The fibres used for producing the woven or the Non-woven material, may typically have a size of 0 005 - 120 dtex, more preferred 0, 1-80 dtex and most preferred in the range 0 5-20 dtex

In accordance with one aspect of the invention, the second material is a soft, and somewhat elastic material having an elongation at break of above 25%, more preferred above 50% and most preferred above 100% in the form of a woven or non-woven material

The mateπals used to produce the woven or non-woven may be chosen among the materials in the above mentioned list, or among other naturally or synthetic fibres suitable for producing a woven or a non-woven

A woven or non-woven material may be a composite, consisting of two or more different materials.

The woven material may be produced by any method known per se, e.g. weav¬ ing or knitting.

Elasticity may be imparted to a woven material made from a material not being elastic in itself by weaving in special patterns giving rise to an elasticity of the woven material.

A third material may be chosen from a wider range of polymers and other materi¬ als. It is evident that the use of hard fibres or particles will have an effect to en- hance the transmission of sensations. In the form of fibres, the third material will add significant strength to the first material. The fibres may typically have a size of 0.5 - 120 dtex, more preferred in the range 1-20 dtex. The distribution of fibres are important, e.g. a three-dimensional isotropic orientation of fibres will ensure that some fibres will be oriented so a direct pressure transfer is possible. The size of particles will vary from 1 microns to 500 microns.

Loose fibres or particles may be selected among the materials in the above men¬ tioned list of polymers or chosen among other materials, such as minerals, met¬ als, metal oxides organic- or inorganic materials, suitable for producing fibres or particles. The fibres may e.g. be chopped fibres.

The second and/or the third material may have undergone a special treatment in order to give the surface desired properties, e.g. in order to enhance adherence, for example by corona treatment, plasma treatment or treatment with silane and/or acids or bases or any other surface treatment known per se.

The condoms of the invention may e.g. be prepared by any conventional method for preparing condoms, e.g. dipping or rolling in a latex, solution and/or powder

followed by heating, by injection moulding, extrusion and blowing, e g in a man¬ ner analogous to the method disclosed in , or spraying of a powder, solution of polymer or melt onto a mandrel followed by heating

In a further aspect the invention relates to a method of providing a improved sen- sibi ty while using a condom in sexual intercourse, the sensation being different the sensation using a conventional condom, said method being characterised in that the male partner uses a condom which comprises, at least on a part of the inner and/or outer side, a physiological barrier material being able to transmit pressure impulses, friction and heat, said barrier material comprising a) a first constituent in the form of a physiologically acceptable synthetic polymer, natural polymer and/or a biopolymer and b) optionally a second constituent in the form of a woven, non-woven or "knitted" material and c) optionally a third constituent in the form of fibres and/or particles of a physiologically acceptable material being compatible with the first constituent, and the second constituent if present

In yet another aspect the invention relates to a sheet or formable substance for applying to a penis Such a sheet or substance may comprise, at least on a part of the intended inner and/or outer side, a physiological barrier material being able to transmit pressure impulses, friction and heat, said barrier material comprising a) a first constituent in the form of a physiologically acceptable synthetic polymer, natural polymer and/or modified natural polymer and b) optionally a second con¬ stituent in the form of a woven, non-woven or "knitted" material and c) optionally a third constituent in the form of fibres and/or particles of a physiologically ac¬ ceptable material being compatible with the first constituent, and the second con¬ stituent if present

Upon application the sheet or substance functions as a traditional condom show¬ ing the effects of the present invention

It is envisaged that the sheet or substance may be applied manually or by using an applicator wrapping the sheet or forming the substance around the eπgated penis

For the purpose of the present invention the term "condom" is covering ail con- ventional definitions of condoms as well as condom-like articles which may fulfil the purpose of the present invention

MATERIALS AND METHODS

EXPERIMENTAL PART

The invention is explained more in detail below with reference to the Examples disclosing embodiments of the present invention The examples are not consid¬ ered to be limiting to the scope of the invention which is defined in the appended claims The chosen plasticizers could have a lubricating or biological effect as described in the appended claims

For all examples given it is possible to add an anti-blocking layer as the last pro- duction step

EXAMPLE 1

Nylon stocking having a barrier polymer.

Reference is made to Fig 1 & 2 A condom is produced by preparing, by knitting in a manner known per se, a "stocking" 1 from polyamide/Lycra fibres 2, said "stocking" having essentially the form of a condom, placing the "stocking" on a mandrel and dipping the mandrel into latex by a conventional dipping technique for the preparation of condoms or uπdoms Fig 2 shows a enlarged section of the condom in Fig 1 showing the fibre 2 and the latex 3

Alternatively, the mandrel may be dipped into a solution or aqueous dispersion of the same material

The polyamide imparts strength and structure to the condom combined with the barrier formed by the polymer

EXAMPLE 2

PU non-woven material having a barrier polymer

Reference is made to Figs 1 & 3 A condom is produced by preparing, by forming in a manner known per se, a "stocking" 1 from a non-woven 4 PU material said "stocking" having essentially the form of a condom, placing the non-woven PU material on a mandrel rolling the PU material dissolved in methylene chloride onto the mandrel by a manner known per se and curing the PU material by heat¬ ing for 10 to 20 minutes at a temperature of 20 to 40 ° C Fig 3 shows a en¬ hanced section of the condom in Fig 1 showing the fibre 4 and PU polymer 5 It is to be ensured that the non-woven PU material is not dissolved during this process This may be accomplished by using an insoluble PU material or by re¬ ducing the time of contact with the solvent to a sufficiently short time

The non-woven PU material imparts strength and structure to the condom com¬ bined with the barrier formed by the PU polymer

The experiment is repeated using methylene dichloπde or tetrahydro furane in- stead of methylene chloride

EXAMPLE 3

Loose fibres combined with barrier polymer and polymer gel

Reference is made to Figs 1 & 4 Hard fibres 6 made from chopped cellulose fi¬ bres prepared by a manner known per se are applied onto a mandrel by using electrostatic technique A barrier polymer "film" 7 is made from PU dissolved in

methylene chloride which is sprayed on the mandrel or applied by a conventional dipping technique for the preparation of condoms or uπdoms in such an amount that the structure of the fibres is conserved Then plasticized crosslinked CMC gel 8 is applied to one or both sides of the condom This may be done by dipping the mandrel into the gel material or by spraying the gel material

The fibres ensure transmission of sensations, the polymer is used as an overall binding and barrier material and contributes to the strength of the condom and the polymer gel imparts a lubricating and sticky effect to the condom The poly¬ mer ensures that the fibres are secured and do not give rise to rubbing off of fi- bres during use The fibres may also impart strength to the condom and function as a reinforcing element

The experiment is repeated using methylene dichloπde or tetrahydro furane in¬ stead of methylene chloride

EXAMPLE 4

Loose fibres combined with polymer gel

Reference is made to Fig 5 Hard fibres 9 made from chopped polystyrene yarn prepared by a manner known per se are dispersed in a solution of SEBS (styrene-ethylenebutadiene-styrene copoiymer) in a mixture of toluene and hex¬ ane A condom in the form of a matrix 10 of SEBS comprising separated fibres 9 is prepared by a conventional dipping technique for the preparation of condoms or uπdoms

The fibres imparts transmission of sensations, and the polymer material functions as a barrier and also imparts mechanical strength to the condom

EXAMPLE 5

Condom prepared from SEBS (styrene-ethylenebutadiene-styrene copoiy¬ mer) combined with fibers/particles by a conventional manner for prepar¬ ing uridoms

5 Reference is made to Fig 5 Loose fibres of polyester (PET) 9 and plasticized SEBS 10 are mixed with a tackifying resin and a condom is produced by com¬ bined injection moulding, extrusion and blowing technique known for preparing uridoms from thermoplastic mateπals This combined process may e g be car¬ ried out as disclosed in WO 91/17728

10 The experiment is repeated using polyester granules instead of polyester fibres The fibres or granules ensures transmission of sensations, and the polymer im¬ parts mechanical strength and acts as a barrier material The resin imparts a sticky effect to the condom

EXAMPLE 6

15 Nylon stocking having a sticky barrier layer

Reference is made to Fig 1 & 6 A condom is produced by preparing, by knitting in a manner known per se, a "stocking" 1 from polyamide/Lycra fibres 11 , said "stocking" having essentially the form of a condom, placing the "stocking" on a mandrel and dipping the mandrel into a silicone prepolymer 12 After curing for 20 20 minutes at 120 ° C a weakly adhering surface is obtained

The stocking imparts strength and structure to the condom and the polymer acts as a barrier and is weakly adhering on both sides giving rise to a heightened sen¬ sation during use

EXAMPLE 7

Condom prepared from silicone

A curable silicone (Silastic Q7-4720, Biomedical Grade ETR from Dow Corning) was dissolved in heptane. A conventional mandrel fro the preparation of con- doms was dipped into the solution several times to obtain a thickness of 50μm. The resulting condom was extremely soft and characterised by having an elon¬ gation at break of 1200% and a very pronounced friction enabling a heightened sensation during use