SE9400699A0 - A method of improving sexual relationships - Google Patents

Abstract

ABSTRACT The invention relates to the use of a local anaesthetic in the manufacture of an easy dispensing form for the treatment of premature ejaculation (PME) or for use by partners wanting a longer sexual intercourse, wherein the local anaesthetic is contained in a disposable package of a material which is inert and impermeable to the local anaesthetic.

Description

' UPPFINNINGENS BENAMNING i. 1-111/1-( i-r■ o cl',(-4(loN\ v 'Yvoo \in.v::,(N,-...\ kvI\ s IA 13 S ---- — SOKANDE Namn odr ch aess.

Om ombud saknas ange aven Ert teletonnurnmer.

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Sokande befullmaktigar nedanstaende svenska ombud genom separat fullmakt. -'4-..•::•'•-::;.t1-• Ombudets ref nr BEGARAN OMPRIORITET Datum, land och ansekningsnummer .. 90 ') 01 'ycA VID DEPOSITION AV MIKROORGANISM Depositionsmynthghet 1-- Dep.09:or,qdatumI DopoSittOnsnr VID AVDELAD ELLERSlaniansokn.ngsnrTTiegard Ibpdag UTBRUTEN ANSOKNING BEGARAN OM ITS- GRANSKNINGNyhelSgransknorti av Internationellt slak _Li_ BILAGOR NI Beskrivning, patentkrav och sammandrag 1 tre exemplar i6(....ritningar 1.3exemplar [IOverlatelsehanaling n Fullmakt 0 Sekvenslista pa diskett enngt Li PrioritetSbeviS r] AVGIFT 'V Grundavgift : 1600 kr -V]Tillaggsavgift, 100 kr for varie Li Diariebevis , 20 kr Li Grundavgilt (Or ITS-granskrimg ri Tiltaggsavgift for ITS-granskning, yule patentkrav BETALNINGSSATT Postgiro_ ki:-:•;'V: k 1 0kkA1 4 On datum EPOs program Patent In , ,..----1V1(1 \.. lif7tierfAr.ft....______________—_-______ 7atentkrav utOver tie, 2..0-0k, 2 000 kr 100 kr. fer utOver 10,kr • fal Checkl'il Kontant.. -•,_ -•_---- -'-• s• ••• • • •S ••• ••■•• *ot •• ••• ••• •••• •• • •• • • •• • •••• •• •• •••n •••• •••• • •• •• •• •• • 00••• • • •••• ••••• • v••• • •••• •• 1 A USE OF LOCAL ANAESTHETICS FIELD OF THE INVENTION The present invention relates to the use of local anaesthetics in the manufacture of an easy dispensing form for the treatment of premature ejaculation (PME). More specifically it relates to the use of local anaesthetics in the dispensing form of a disposable package, with or without an occlusive dressing in the treatment of PME.

The invention also may be used by partners not suffering from a PME problem but simply wanting to have a longer sexual intercourse.

BACKGROUND OF THE INVENTION The definition of the term "premature ejaculation" according to DSM-III-R is "a persistent or recurrent ejaculation with minimal sexual stimulation before, upon or shortly after penetration and before the person wishes it".

Studies have shown that PME is a widespread problem in sexual relationships. Indeed, mention is made of a much as 75 % of men ejaculating within 2 minutes after penetration, and an important number of men reaching climax even within 1 minute of coitus.

This situation may be the cause of psychological disturbances for the man suffering from PME, as well as for his female partner.

There is no reliable documentation identifying the etiology of PME, but different theoretical concepts exist. They relate the problem to 1) hypersensitivity of the glans penis, resulting in excessive stimulation of the sexual center in the central nervous system, 2) anxiety, 3) destructive interactional patterns, 4) learning and conditioning from early sexual experiences, and 5) multi-factorial causes.

J The presently existing methods of treating PME are on the one hand of a psychological or "technical" type, such as the "pause- •• ••• • ••• •••••• ••• • • • •• • •• • •• •• •• • •• • • •• • ••••• " :..•••• •••• • • • • • •• • • •• • • ••• • it•••• • •••• • •••• •• 2 squeeze" method (W. H. Masters and V. E. Johnson, Human Sexual Inadequacy, Little, Brown & Company, Boston, Massachusetts, 1970) and on the other hand of the pharmacological type. Thus, a variety of pharmacological techniques have been reported to delay or block an ejaculatory response. While reporting variable success rates, studies have been largely uncontrolled. Apart from the use of systemic drugs such as antidepressants or beta blockers, with evident drawbacks resulting from the side effects of the pharamceutical, one of the interventions has been to apply topical anaesthetic to the penis before the sexual intercourse (Schapiro, J. Urology, 50, 374-379, 1943. Aycock, J. Urology, 62, 361-362, 1949. Damrav, J. Urology, 89, no. 6, 936-939, 1963).

It is generally admitted that the mechanism of action of topical anaesthetics consists of a blocking of the pain skin receptors and pain fibers, thus providing analgesia. The local anaesthetics my also block the tactile receptors and the nerve fibers that convey the tactile sensory input, which is important for ejaculation.

Many topical anaesthetics in use for local analgesia have existed on the market for a long period of time, e.g. the last 30 years. They have been used among others in procedures involving the male and female urethra and as anaesthetic lubricant for endotracheal intubation (oral or nasal). They accordingly have had time to be well studied and have rare skin and mucosal irritation (less than 1/1000).

Local anaesthetics have the ability of abolishing the sensation at the site of application. They penetrate intact skin and the mucous membrane due to their pharmaceutical properties, or may be transported into the skin and underlying tissues by the use of iontophoresis, or by the addition of a penetration enhancing formulation (e.g. DMA or Azone0).

Single dose disposable packages for different drugs and especially gel and cream form drugs are known and widely used. These are easy to handle and safe to use. Moreover, the use of an occlusive dressing to apply a gel on.the skin has lately been practiced for 04• • O. •00 f.1111 Of • • • •• • •• • •• •• .0. • ::".01 0... • 0*••• • • ••• • ••**• • .000 • .000 Of 3 a limited number of indications, showing good results.

In using the local anaesthetic, the best result is obtained by applying the agent on the penis a short period of time before coitus, i.e. 5 to 10 minutes before penetration. In this way, local anaesthesia has time to be established on the penis, and the excess of the local anaesthetic can subsequently be wiped away before coitus. This also minimizes the risk of the female partner being contaminated with the local anaesthetic in her genital parts at the intercourse.

However, this application in advance of the local anaesthetic gives rise to another problem, namely that of the smearing of the agent e.g. on clothes, hands or other parts of the body.

It would therefore be an advantage to have a means of easy application of the local anaesthetic, permitting to keep the local anaesthetic on the penis for as long as necessary before the intercourse while minimizing the risk of smearing of the local anaesthetic.

The above objects are obtained by the present invention.

SUMMARY OF THE INVENTION The object of the invention is the use of a local anaesthetic in an easy dispensing form for the treatment of premature ejaculation (PME). More specifically it relates to the use of local anaesthetics in the dispensing form of a disposable package, with or without an occlusive dressing for the treatment of PME.

The subject of the invention may also be used by partners not suffering from PME, but simply wanting a longer sexual intercourse.

DETAILED DESCRIPTION OF THE INVENTION The packages for local anaesthetics presently available on the market contain at least 20 ml, however, to delay the ejaculation a quantity of not more than about 2 ml is needed. Thus, a preferable •• • • 110 I•• •••• • •• • •• • •• •• •• " Ia0: :•:* • : : r.• • •• ••• • •••• • • ••• • o ••••• • •••1 I •••• •• 4 package would have part or all of the following features: the package should be small and easy to carry around, containing a volume of 0.5-5 ml of the local anaesthetic, preferably 1-2 ml; it should tolerate external pressure to avoid inadvertent opening; it should be easy to open and to use for the dispensing of the agent on the relevant part of the body while avoiding to get said agent on other parts of the body, e.g. the hands.

Part or all of the above points can be reached for example by using the packages illustrated in the accompanying drawings, to which reference will be made in the examples herein below. The occlusive material could be any material that holds the agent on the organ and protects it from removal. After -20 minutes of application time the occlusive will Ue removed and a piece of tissue or cotton which might follow the package can be used to clean and to remove the excessive amount of the formulation.

The best results and the most convenient way of applying the topical anaesthetic was.reached by applying it 5-10 minutes before sexual intercourse under an occlusive latexlike material. the device used for occlusion was either a half or whole condom. Any material of any design can be used and the important point is to hold the anaesthetic agent or agents in contact with the sex organs. The agent will not be removed by contact with clothes or other body parts of the user or his partner, and it is not absorbed by the occlusive dressing.

A further way to apply the local anaesthetic preparation is to use dressings soaked with the local anaesthetic preparation. The dressings can be sterile or non-sterile.

The topical local anaesthetic formulation used according to the invention is characterized by its ability to penetrate intact skin and the mucous membrane due to its pharmaceutical properties, or may be transported into the skin and underlying tissues by the use • • ••• • • •••• : • • • • • • : -00. . 4. . 410.4 • • ••• • • 0.0 6 0• .* • • : 01 of iontophoresis, or by the addition of a penetration enhancing formulation (e.g. DMA or Azone0).

The formulation should contain at least one local anaesthetic agent, available now in use, in the form of its base or a pharmaceutically acceptable salt thereof, or a eutectic mixture of local anaesthetics of the aminoamide type (e.g. lidocaine, mepivacaine, procaine, prilocaine, bupivacaine etc.).

The local anaesthetic(s) is (are) incorporated into a jelly, emulsion, cream, ointment, spray solution or film-forming formulation.

The local anaesthetic formulation contains from 0.25% to 20% by weight of the local anaesthetic(s), preferably 2%-10%.

The local anaesthetic or anaesthetics is (are) available commercially and examples of pharmaceutical formulations containing the local anaesthetic are as follows: Formulation 1: Ointment 5% (Jg) Lidocaine 50 mg propylene glycol macrogol . aq. purif. qs Formulation 2: Jelly 2% (hull Lidocaine hydrochloride 20 mg chlorohexidine,gluconate metagin preservatives propagin propylene glycol hydroxyethyl cellulose eq. steril. qs The above formulations are only given as non limitative examples, and while formulation 2 is preferred, any formulation containing one or more anaesthetics, optionally in the form of a physiologically acceptable salt, can be used for the purpose of •• • •• • • ••• • 0• • 0• • •• - • • -••• • • • 0 •• SO. • • •• •I •• S.. :" • Is:•le• •••• e • •• .• • • •• • • •••• • ••4.1• • •••• • •••• •• 6 the invention.

The preparation, if desired, can also contain various perfumes, colouring agents, and flavouring agents, e.g. fruit flavours. Any ingredients which are used must be skin compatible, inert towards the active ingredient, and of a nature and used in an amount which does not destabilize or upset the general consistency of the formulation.

The invention will now be illustrated by way of non-limiting examples referring to the drawings wherein: Fig. la-c is a view of a 'half condom' meant to be used for the application of the local anaesthetic. Fig. la is a side view of the half condom, showing the elastic I which holds the half condom in place on the penis. Fig. lb is a sectional view along the line A-A in fig. la, showing the wall 2 of the half condom, in a material which is inert and impermeable to the local anaesthetic, such as a latex material. Fig. lc is a view from underneath, showing the inside 3 of the half condom as well as the elastic 1.

Fig. 2a-e is view a disposable package 4 containing a small amount of from 0.5 to 2 ml, preferably from 1 to 2 ml. of a local anaesthetic in gel or cream form.

Fig. 2a is a side view of the disposable package 4, showing the peripheric plastic welds 5 which are narrowed at the indentation 6, such as to permit an easy opening of the disposable package.

Fig. 2b is a view from behind of the same disposable package, whereas fig. 2c is a view from the side along the edge 7 provided with the indentation 6.

Fig. 2d represents the disposable package being opened by tearing at the indentation 6 such as to rip off the edge. Fig. 2e represents the disposable package after opening. The local anaesthetic 8 will easily be pressed out of it, to be applied on the penis either directly from the package or from hand. 71.1". ;00— Is;.04: 06:40 •: • .4r ; • • V* • OfVO • 000. OV V 0 • • 7 Fig. 3 represents another, but very similar, embodiment of the same type of disposable package as that of fig. 2.

Fig. 4a-d represents a disposable package in the form of a small tube 9. To facilitate the application of the gel or cream local anaesthetic 10, a plastic foam upper part 11 is provided around the neck 12 of the tube, allowing smooth and clean application.

Fig. 5 represents another embodiment of the tube 9, without the plastic foam upper part, having a more conventional cap 13.

Fig. 6a-e represents a disposable package 14 with an outer layer 15, impermeable to the local anaesthetic and an inner layer 16 consisting. of a tissue soaked in the local anaesthetic 17.

Fig. 6a is a side view of the package showing the same type of of plastic weld edges 5 and indentation 6 for easy opening as in the disposable package of fig. 2.

Fig. 6b is a sectional view along the line A-A, showing the outer layer 15, the inner layer 16 and the gel or cream local anaesthetic 17.

In fig. 6c-d the use of this disposable package is represented. After opening the package by ripping the edge 18 off, as shown in fig. 6c-d, the penis is introduced into the package for application of the local anaesthetic on glans penis, as shown in fig. 6e. In this way the hands do not have to come in contact with the gel or cream local anaesthetic. The product can also be delivered with a condom.

Fig. 7a-e represents a disposable package of comfortable opening, containing the gel or cream local anaesthetic. As shown in fig. 7d-e, by lifting and pulling apart the flaps 19, the package is opened.

Fig. 8 represents a similar disposable package as according to fig. 7, but the package here contains a tissue 20, soaked with a e• • .1,O. 8 local anaesthetic formulation. The tissue is fastened to the inner side of the cover so that it can not be removed from the package, and the user thus avoids to touch the gel or cream local anaesthetic with his hands. The user will apply the gel/cream local anaesthetic directly on the glans penis and/or on the shaft of the penis.

Fig. 9a-b represents a patch 21 making it possible to apply a gel/cream local anaesthetic before the penis has risen. In use, the adhesive surfaces 22 and 22" are pressed together around the penis. Thus the area 23 of the patch, soaked with the local anaesthetic, or to which a local anaesthetic has previously been applied, will stay in contact with the glans penis. The patch should be taken off before penetration.

Fig. 9b shows the aspect of the patch in use, with the adhesive areas 21 and 21",respectively, joined together.

The disposable package should be of a material which is inert and impermeable to the local anaesthetic and not susceptible to inadvertent transpersal. Its manufacture is carried out by conventional techniques. Non limiting examples of the material of the different types of disposable packages as well as their manufacturing processes will now be given.

Disposable package (according to fig. 2, 3, 6, 7, 8) The package material may be of a layer type, consisting of two or more layers. An example which is used in the industry today has a three layer construction. The reasons for using the layer-construction are to make the package airtight to increase durability and to make the package persistent to pressure. layer materiallayer thickness polyester foil12 pm aluminium foil7 pm polythene foil70 pm The production of this kind of disposable. .package material starts 9 with printing on the polyester foil. To fasten the aluminium foil, a film of glue is applicated. The aluminium foil is thereafter being pressed on the polyester. Normally, the glue contains solvent which must be removed by heating. The same procedure with glue and heating is used to fasten the polythene film.

Another type of package material is made of metallized polyester. Powder of metal is applied on polyester foil with a thickness of 70 pm approximately.

The final package will consist of two pieces of the above described package material, either of the layer type or metallized polyester. Packaging of anaesthetic in the disposable package is similar to the process used e.g. in food production and production of cosmetics. The two pieces are being brought toghether by e.g. two heated rollers. The heat from the rollers will bring the polythene foils into the melting zone and pressure from the rollers will create a plastic weld (as 5 in fig. 2) and make the surfaces fasten to each other. The package is being filled with anaesthetic fluid from nozzles simultaneously.

Disposable package (according to fig. 4, 5) The tube ve:sion of a disposable package could be made of e.g. the following materials: aluminium polythene layers of polypropylene and polythene (with film of ethyl vinyl alcohol in between) layers of aluminium and polythene (aluminium between iayers of polythene) The production techniques for both described packages are well known in the food and cosmetics industry and is described by e.g. Akelund & Rausing AB, Lund, Sweden (manufacturer of packaging material).

Disposable package (according to fig. 9) • • •••• • • • •• • • • • •• • • • • • •• • •• • :••• :•••: :•:• : *7. •••••: • ••• :••: : •• • •• • • • •• • •••• •• 10 The patch may be of the normal patch materials existing on the market. According to representatives of Belersdorf AB, Kungsbacka Sweden, patches are basically made of either viscous polyamide or foil of polythene (perforated). The parts of the patch wished to be rendered adhesive could be covered with e.g. a mixture of zinc oxide and cautchouc.

The dressing containing the anaesthetic according to figures 6, 8, and 9, rsepectively, could be made of e.g. cotton, polypropylene or polyamide. Polyamide and polypropylene are often used in hygienic articles as e.g. napkins and are manufactured by AB Derma, NorrkOping, Sweden. • • ••• •• • • 4• • • • • • • • • .• ••• • . •• ••••• • • ••• • •••• • • • • • • • • • • • • • : •• • • •• • • •••• •• "(u

Claims (17)

CLAIMS 1. Use of a local anaesthetic in the manufacture of an easy dispensing form for the treatment of premature ejaculation (PME) or for use by partners wanting a longer sexual intercourse, wherein the local anaesthetic is contained in a disposable package of a material which is inert and impermeable to the local anaesthetic. 2. Use according to claim 1 wherein the disposable package contains a volume of 0.5-5 ml of the local anaesthetic. 3. Use according to claim 1 wherein the disposable package contains a volume of 1-2 ml of the local anaesthetic. 4. Use according to any of the above claims wherein the disposable package comprises an occlusive dressing. 5. Use according to any of the above claims wherein the occlusive dressing is chosen from a half and a whole condom. 6. Use according to any of claims 2-3 wherein the disposable package is a tube_(9). 7. Use according to claim 6, wherein the tube (9) comprises a rubber foam applicator device (11). 8. Use according to any of claims 1-3 wherein the d'sposable package (14) is of a two layer (15, 16) structure, the inner layer (16) being soaked with the local anaesthetic formulation (17). 9. Use according to any of claims 1-3 wherein the disposable package comprises a patch (21) of a geometry adapted to be applied to the penis, having a central area (23) soaked with the local anaesthetic, surrounded by adhesive areas (22, 22). 10. Use according to any of the above claims, characterized in that the local anaesthetic is in the form of its base or a pharmaceutically acceptable salt thereof, or a eutectic mixture of • :: It• • • •• • • • • •• • • •• •• ••••• •• 12 local anaesthetics, of the aminoamide type (e.g. lidocaine, mepivacaine, procaine, prilocaine, bupivacaine etc.). 11. Use according to any of the above claims, characterized in that the local anaesthetic(s) is (are) incorporated into a jelly, emulsion, cream, ointment, spray solution or film-forming formulation, optionally also containing various perfumes, colouring agents and tastes. ABSTRACT The invention relates to the use of a local anaesthetic in the manufacture of an easy dispensing form for the treatment of premature ejaculation (PME) or for use by partners wanting a longer sexual intercourse, wherein the local anaesthetic is contained in a disposable package of a material which is inert and impermeable to the local anaesthetic. •••••■••,•••••••••••••••■••••••••••••••••••■,•••■••••••••■■+.•••••••••••■••••••••••••••••••■•••••••*•.+••.•••••N 1. •• • 2. • 3. • 4. • • •• • •••• 4,0 5. •• •• e • • • . • • LIL- 9 q 0 0) * (C. ••• 6. • 7. • : . • • •• 0 8. • 9. • S " : 10. •.• 11. II 12. •• 0.: •• : 13. • • ••• a v•• 14. • e•• . • 15. • • • 16. • " 17. • 18. * 19. • •• fi3 Ilabls a 006 16 I a Sex...bon 14 - A TO* Helf condom ••■•••••*••■••••■*•••••■•• —. 1. 14M—rem41* 1. •• •• • 4 2. ••• • I • 614 0 0 (6' q I•• ••• • 3. • •• 4. ••••• s•-•• 5. • 6. •• 7. .00•.**.a4.laft0.•••••••■• 8. • •• •• I• • • •• • IV 9. *•• • :: 10. •" • • • •••• •• . 2 b 2(. 2 e "-^^••••••• ....-••■•■•••••••01■.••••••••■• r•••••• IV* >•*c p I a.St '‘C Wei Ci o 3d Or Crtr.) 7VP" 0■-3p01061( pot: PJ15e!htsnierenal 2. a 1 +. • • • • • ••• • •• •• •• •• to 1. • •• • •• • 6• 6 •• •• — ................................•••• ••••••.................-••• re••••••••••.• -•---•—•••.•• 11. ..--•••••■•-• 1. • • AI • •• *••• 0.1•• • e0 •• •• •• ..,.•• • ••••a ••••• ( .t k,,( of\ (C1 (•,4 ..... (tr,o• • • 1. .) ine•• • •••• e •••• t• '3,2=Z973t211,3M) S. • ratio cd ii 1) it.1 t WO4 a!ie. c ' CO! tAtN1 A.Pet•n4g. ; Cs bib; ; ; •; •■••• it

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