Condom with male genital desensitizer lubricant

CA 02436554 2008-11-17

78147-7

CONDOM WITH MALE rAL DESENSITIZES. LUBRICANT

Field Of The Invention

The field of the present invention relates generally to condoms, and more specifically to condoms having alubricant system which includes a genital desensitizing agent sod controls the application thereof to male genitalia.

Background Of IheJtoaaition

Much effort has been made to provide a composition containing a male desensitization agent suitable for preventing premature ejaculation. Many of these compositions provide a

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679 water-based lubricant with benzocaine as the active component at a concentration of from about 3% to 7.5%. Such compositions are inconvenient to use, in that they require direct application to the male genitalia prior to intercourse. In addition, these compositions typically expose the female partner to the composition and its desensitizing effects with such exposure being highly undesirable.

Heidenfelder, (U.S. Patent No. 4,840,188) discloses the coating of the interior surface of a condom with a local anesthetic such as benzocaine to provide desensitization. The location of the desensitizing agent on the interior surface of the condom provides advantages over direct application products.

Despite these efforts, there is still a need to provide a condom with desensitizing capability that can be readily employed without risk of exposure to the female partner and still provide the benefits of a lubricating composition.

Summary Of The Invention

The present invention generally provides a condom that incorporates two distinct lubricating compositions. One such composition is a relatively high viscosity lubricant composition containing at least one desensitizing agent that is bottom shot into the interior of a nipple up condom to coat the interior surfaces thereof. A second, lower viscosity lubricant composition containing no desensitizing agent is top shot on the outside of the condom prior to, or at the same time as following the application of the bottom shot lubricant composition. The

CA 02436554 2009-09-16

78147-7 high viscosity lubricant composition with a desensitizing agent remains substantially in place during packing, shipping, storage, and use so that the full benefits of continuous contact with the desensitizing agent can be realized. In this manner, separation of the first lubricant composition containing the desensitizing agent from the exterior surfaces of the condom is maximized in order to minimize contact with the female partner and thereby avoid desensitization of the female genitalia.

In one aspect of the present invention there is provided a condom comprising:

a male genital engaging tubular sheath having an inner surface and an outer surface;

a first lubricant composition comprising an effective amount of a male genital desensitizing agent located on at least a portion of the interior surface of the tubular sheath, said first lubricant composition having a relatively high viscosity sufficient to maintain the first lubricant composition on the inner surface of the condom during packaging, shipping, storage, and use; and a second lubricant composition containing no desensitizing agent and having a lower viscosity than the first lubricant composition, the second lubricant composition being located on the outside surface of the tubular sheath.

According to another aspect of the present invention, there is provided the condom as described herein, further comprising: a second lubricating composition having a viscosity ranging from 500 ops to 20,000 cps, said second

CA 02436554 2009-09-16

78147-7 lubricating composition being located on the outside surface of the tubular sheath, and being free of said desensitizing agent.

In a preferred form of the invention, the first 5 lubricant composition has a viscosity of from about 10,000 to 75,000 cps, while the second lubricant composition has a viscosity of from about 500 to 20,000 cps.

3a

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679

Brief Description Of The Drawing

Various embodiments of the present invention are described below with reference to the drawings, in which like items are identified by the same reference designation, wherein:

Figure 1 is a schematic diagram showing a method of applying the first lubricant 5 composition to the interior portion of a condom and the second lubricant composition to the exterior portion of the condom for one embodiment of the invention;

Figure 2 is a view similar to Figure 1, the difference being that the condoms are shown in cross section taken along line 2-2 of Figure 1;

Figures 3 through 10 are respective side views of various examples of condoms that can be prepared in accordance with the present invention; and

F igure 11 shows a block diagram of processing equipment for making the first and second lubricant compositions for use in the present invention.

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679

Detailed Description Of The Invention

In one embodiment of the present invention, the interior surface of a condom is lubricated with a first lubricant composition containing a relatively high viscosity lubricant along with at least one male genital desensitizing agent.

As used herein the term “desensitizing agent” means any material including topical anesthetics that reduce the sensitivity of male genitalia in a manner which may prevent premature ejaculation. Examples of suitable desensitizing agents include benzocaine, butambin picrate, dibucaine, dibucaine hydrochloride, dimethisoquin hydrochloride, dyclonine hydrochloride, lidocaine, lidocaine hydrochloride, pramoxine hydrochloride, tetracaine, tetracaine hydrochloride, benzyl alcohol, camphor camphorated metacresol, juniper tar, menthol, phenol, phenolate sodium, resorcinol, diphenhydramine hydrochloride, tripelennamine hydrochloride, and combinations thereof. The preferred desensitizing agent is benzocaine.

The desensitizing agent may be present in the first lubricating composition in a desensitizing effective amount which may be typically from about 0.5 to 25% by weight based on the total weight of the of the composition, preferably from about 3 to 7.5% by weight. In a preferred composition the desensitizing agent is benzocaine in an amount of about 6.0% by weight. It will be understood that the selection of an effective amount of the desensitizing agent is within the skill of the art and will depend in part on the particular desensitizing agent chosen and the type of other components of the first lubricating composition.

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679

The type of lubricants which may be used in the first lubricant composition are selected to provide a relatively high viscosity to the composition. The viscosity should be sufficient to enable the first lubricant composition to be applied to the inner surface of the condom and retained thereon during packaging, shipping, storage, and use without splashing and/or splattering.

The first lubricant composition will typically have a viscosity of from about 10,000 to 75,000 cps at ambient temperatures, preferably from about 10,000 to 25,000 cps. In addition, it is desirable that the lubricant be able to solubilize the desensitizing agent to provide uniform distribution of the same over the inner surface of the condom. Typically, lubricants which may be effectively employed in the first lubricating composition could include but are not limited to glycols (e.g. polyethylene glycols, propylene glycol), water-based gels (e.g. glyceryl polymethacrylate, carboxymethyl cellulose), silicone-based oil and gels, mineral oils, and so forth.

The second lubricating composition which is applied only to the exterior surface of the condom, does not contain a desensitizing agent. The viscosity of the second lubricating composition is lower than the first lubricating composition and allows the lubricant to be easily spread around the rolled condom to lubricate the outer surface thereof.

The viscosity of the second lubricant is typically in the range of from about 500 to 20,000 cps. The selection of a suitable lubricant will depend on the type of condom material.

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679

Typical lubricants used for the second lubricating composition include, but are not limited to, the same lubricants used for the first lubricating composition but with a lower viscosity.

The first and second lubricating compositions may be employed on condoms having a variety of shapes and/or compositions. Typical condom forming materials include natural rubber latex, synthetic elastomers such as polyurethane and the like., and natural skin, such as a lamb secum. Various shapes of condoms employed in the present invention are exemplified by reference to Figures 3-10 as hereinafter described.

A method of applying the first and second lubricant compositions to a condom will now be described with reference to Figures 1 and 2. In one embodiment of the invention, a commercial packaging machine provides an indexed motion in the direction of the arrow 1, for moving rolled condoms 3 in the direction shown. However, in a preferred second embodiment, the motion is not indexed, but rather is timed through the use of rotating cams to activate pumps (not shown) at appropriate times for ejecting associated lubricants from nozzles 7 and 9, for example. This timing embodiment provides for continuous movement of the condoms 3, whereas indexing employs non-continuous movement. The rolled condom 3 with its nipple 5 up first passes beneath a vertical nozzle 7 for applying a relatively low viscosity second lubricating composition 8 on the exterior surfaces of the condom onto and proximate the nipple 5. The condom 3 moves to a position over another nozzle 9 used to apply a first lubricating composition 11 containing a male genital desensitizing agent to the interior or inside surfaces of the condom 3 typically proximate the closed end thereof. The condom 3 which has been provided with the second lubricant composition on the exterior surface of the condom is moved

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679 over the lower nozzle 9. After the nozzle 9 is used to apply the first lubricating composition 11 containing a desensitizing agent to the interior surface of the nipple and adjacent areas, the completely lubricated condom 3 then is encapsulated between the two foil layers 13 and 15, and sealed to form a packaged product as is customary in the art of preparing and packaging condoms. Note that in the example of the lubricant application method of Figures 1 and 2 the nozzles 7 and 9 are not in the same vertical plane, but are staggered, whereby the lubricants 8 and 11, respectively, are applied at different times. In another embodiment, the nozzles 7 and 9 can be located in the same vertical plane (not shown), whereby lubricants 8 and 11, respectively, would be simultaneously applied.

As previously described, the condoms 3 of the present invention can have any desired shape. Representative examples of various shapes and sizes of suitable condoms 3 are shown in Figures 3 through 10. The length of the condoms 3 typically can range from about 160 mm to 220 mm. The nominal length of the condom is typically about 180 mm, with the condom also having a lay-flat width of about 52 mm.

As shown specifically in Figure 3 the condoms 3 may have parallel walls with a nipple at the closed end, or as shown in Figure 4 parallel walls without a nipple. The nipple 5 may or may not be included at the closed end. In Figure 5, the condom 3 has a shape approximating that of a baseball bat. In Figure 6, the condom 3 includes a tapered portion 17 in its otherwise parallel sidewalls. In Figures 7 and 8 the condoms 3 include bulbous lowermost portions 19, with the condom of Figure 7 also including circular texturing 21 and raised nib portions 23. The configuration of the condom 3 as shown in Figure 9 includes texturing in the form of spiral ribs

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679

25, along with raised nibs 23. The configuration of the Figure 10 includes raised successive circular ribs 27. All of the condoms of Figures 3-10 and those not specifically disclosed may be treated with the lubricating/desensitizing system of the present invention.

Example 1

Preparation Of A First Lubricant Composition

A first lubricant composition in accordance with the present invention having the formula shown in Table 1 was prepared as follows:

Table 1

<td></td><td> Ingredient</td><td> Percent w/w</td>

<td> 10</td><td> Propylene Glycol</td><td> 44.0% w/w.</td>

<td></td><td> Polyethylene Glycol 400</td><td> 15.0% w/w.</td>

<td></td><td> Lubrajel®CG*</td><td> 35.0% w/w</td>

<td></td><td> Benzocaine USP</td><td> 6.0% w/w</td>

<td></td><td></td><td> 100.0%</td>

* Lubrajel® is a registered trademark of Guardian Chemical 15 Corporation, Hauppauge, New York and contains glyceryl polymethacrylate, propylene glycol and water.

A method for manufacturing the first lubricating composition shown in Table 1 is now be described, with reference to Figure 11. A hemispherical jacketed kettle 31, is provided with heating and cooling equipment. The kettle is equipped with a variable speed counter current sweep scraper, and a variable speed air mixer with propellers, as known in the art, to provide proper agitation. Three pumps, represented by numerals 33 through 35, are used to charge the

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679 kettle 31 with the particular components of the composition shown in Table 1. A Graco FT-14 pump 33 is preferably used to pump the lubricant Lubrajel® CG product into the kettle 31. In certain applications only a single pump 33 may be required due to the very high viscosity of the Lubrajel® CG. Once the first lubricating composition is formed, a 100 mesh SS Triclover type strainer is used to provide a filter 3 6 for filtering the first lubricating composition prior to placing the same into a storage container 37. Typically, the storage container 37 is provided by a plurality of storage drums constructed of stainless steel, or high density polyethylene, or polylined fiber drum.

For the preparation of a batch of about 1,400 kg (kilograms) of the first lubricating composition shown in Table 1, the pumps 33-35 are operated to discharge 616 kg of propylene glycol, 210 kg of polyethylene glycol, and 490 kg of Lubrajel® CG into a 400 gallon capacity kettle 31 from a storage container (not shown), respectively under stirring with a variable speed counter current sweep scraper, and variable speed airmixer with propellers. The contents of the kettle are heated to between 75°C and 80°C. During heating the air mixer is increased in speed to break up gel bodies and the kettle is charged with 84.0 kg of benzocaine. While maintaining the temperature of the contents of the kettle between 75 °C to 80°C, the mixture is stirred until the gel bodies have dissipated, typically from two to four hours. When the gel bodies have dissipated, the speed of the agitation equipment is decreased, while mixing is continued for a minimum of four hours at a temperature of 75°C to 80°C.

After mixing as described above, the batch is cooled to between 65°C and 70°C. When the batch is cooled, it is then discharged from the kettle 31 through the filter 36 into storage

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679 drums 37. The viscosity of the thus produced first lubricating composition is in the range of from about 10,000 to 75,000 cps which may be adjusted by altering the amount of the respective starting materials.

Example 2

Preparation Of Second Lubricating Composition

A second lubricating composition containing no desensitizing agent and having the formula shown in Table 2 was prepared in the following manner:

Table 2

<td> Ingredient</td><td> Percent w/w</td>

<td> Proplylene Glycol</td><td> 68.20</td>

<td> Polyethylene Glycol 400</td><td> 6.80</td>

<td> Lubrajel® CG*</td><td> 25.00</td>

<td></td><td> 100.00%</td>

* Lubrajel® CG is a registered trademark of Guardian Chemical Corporation and contains glyceryl polymethacrylate, propylene glycol and water.

For the preparation of a batch of about 1,400 kg (kilograms) of the second lubricating composition shown in Table 2, the pumps 33-35 are operated to discharge 954.8 kg of propylene glycol, 95.2 kg of polyethylene glycol, and 350 kg of Lubrajel® CG into a 400 gallon capacity kettle 31 from a storage container (not shown), respectively under stirring with a variable speed counter current sweep scraper, and variable speed airmixer with propellers. The contents of the kettle are heated to between 75°C and 80°C. During heating the air mixer unit is increased in

CA 02436554 2003-06-04

WO 02/45573

PCT/US01/47679 speed to break up gel bodies. While maintaining the temperature of the contents of the kettle between 75°C and 80°C, the mixture is stirred until the gel bodies have dissipated, typically from two to four hours. When the gel bodies have dissipated, the speed of the agitation equipment is decreased, while mixing is continued for a minimum of four hours at a temperature of 75°C to

80°C.

After mixing as described above, the batch is cooled to between 65°C and 70°C. When the batch is cooled, it is then discharged from the kettle 31 through the filter 36 into storage drums 37. The viscosity of the thus produced first lubricating composition is in the range of from about 500 to 20,000 cps which may be adjusted by altering the amount of the respective ingredients.

Although various embodiments of the invention have been shown and described, they are not intended to limit the invention as encompassed by the claims forming part of the application. Those of skill in the art may recognize certain modifications to these embodiments, which modifications are meant to be covered by the appended claims.