US3262450A - Vaginal applicator - Google Patents

Description

United States Patent 3,262,450 VAGINAL APPLICATOR Nathaniel M. Elias, 56 Washington Mews, New York, N.Y. No Drawing. Filed Apr. 2, 1962, Ser. No. 184,538 4 Claims. (Cl. 128-270 This invention relates to improvements in topical applicators, more particularly to topical applicators to be used on the mucous membranes of the vaginal cavity.

It is known to apply topical remedies and conception control media by means of sponges or sponge-like masses in the vaginal cavity. A method for the above-mentioned application is described in U.S. Patent No. 2,943,979. This method has found considerable acceptance in conception control practices; however, there has been still some reluctance in potential users due to the bulkiness and appearance of the sponge-like masses used heretofore.

The problem of overpopulation is increasingly gaining recognition throughout the world, especially in countries where such problems are eminently in the economic focus. One of the most serious problems in impressing the population in such countries of the benefits, and necessity of such practices, was the users reluctance towards such practices for esthetic reasons. Therefore, considerable ef forts have been made towards developing methods and means to facilitate the practice of effective birth control methods and to devise more appealing ones.

The most effective and economically most feasible methods involve the use of foam producing spermicidal compositions which .are topically applied with sponges or sponge-like masses. Marine sponges have been suggested, but they are found unsatisfactory because of the large size of the pores and irregular cellular structure of the sponges and their unavailability in a form having a uniform cellular structure and uniform apparent specific gravity. The apparent specific gravity of cellulose sponges is approximately 0.055 and that of rubber sponges is approximately 0.l. The average pore size of these sponges is between 12 mm. in diameter.

Because of the relatively large pores and the uneven cellular structure of known applicators the foam holding capacity and the amount of foam produced, as compared to the size of the applicator was unsatisfactory, necessitating on occasion even repeated applications. The weight of the known topical applicators is appreciably large, detracting from its aim in gaining popularity. The non-uniform and large pores contribute to the decreased available area of pore sidewalls, also much was left to be desired in strength and durability of the applicators.

It is an object of the invention, therefore, to provide topical applicators overcoming the disadvantages of prior applicators.

It is another object of the invention to provide an applicator -having increased user appeal and lighter weight.

It is yet another object of the invention to provide a topical applicator having increased strength and durability over known applicators.

Another object of the invention is to provide a topical applicator having increased foaming agent-holding capacity and better continuous foam exudation properties than known types of applicators.

It is a further function of the invention to provide topical applicators having smoother and more even surfaces and improved shape.

According to the invention it has now been found that by using sponge-like masses having an apparent specific gravity of between 0.01 and 0.04 and a uniform cell structure, and in which the average pore size does not exceed 1.5 mm. diameter, the above-mentioned objects of the invention can be accomplished. By providing the appli- 3,262,450 Patented July 26, 1966 ice cators according to the invention with a smaller and more uniform pore size, the surface of the walls of the cells is materially increased, therefore, the foaming agent-holding capacity of the applicator is greatly increased, furthermore contributing to a more random distribution of the cellular building blocks of the mass giving it more strength, rigidity and durability.

As the foaming agent-holding capacity of the applicator is enlarged, an increased capacity for the exudation of foam follows, whereby, it has been found, the foam exudation takes place at an improved, more uniform rate and can be maintained throughout a materially longer period than possible theretofore.

Due to the larger average specific area (area per unit volume) of the sidewalls of the pores, the bulky appearance and the weight of the applicator is decreased, in fact, it has been established in tests where patients were offered a choice between known topical applicators and topical applicators according to the present invention, three times as many patients chose the method providing for the use of the applicator according to the invention.

Contributing to the user acceptance of the applicators is the fact that the cupping, shaping, or molding of the applicators results in a product having smoother and more uniformly even sidewalls and outlines due to their uniform average pore size.

As mentioned briefly at the outset, the applicators according to the present invention are also useful in the treatment of various types of vaginal disorders. Foaming materials, such as sodium lauryl sulfate or p-triisopropylphenoxypolyethoxy-ethanol are used in the treatment of ailments as such Trichomonas Vaginalis Vaginitis, in concentrated or diluted aqueous solutions. The improved continuous exudation properties of the applicators of the present invention contribute to more effective treatment since the application of the medication thus can be made continuous for increasing periods without frequent and inconvenient repeated applications.

For the purposes of applicators, according to the invention, preferably polyester or polyether urethane foam sponge materials are used. The polyester urethane sponge materials generally belong to a class of foams made by reacting polyesters, which are formed by reacting dibasic acids such as succinic, sebacic, etc. acids, with difunctional alcohols, such as, for example, propylene glycol with tolylene diisocyanate. The polyether urethane sponge materials generally belong to a class of foams made by reacting the polyoxypropylene adduct of a dior trihydroxy alcohol, such as, e.g., sorbitol, propylene glycol, or mixtures thereof, with tolylene diisocyanate, or the like.

In the following, several examples are to be given to better illustrate the invention. It should, however, be understood that many changes in the details could be made without departing from the spirit of the invention.

Example 1 According to this example of the invention, a spongy topical applicator is provided, made of a polyether urethane plastic material. The specific gravity of the applicator is 0.015 and the average pore size is 0.5 mm. The color of the sponge is shocking pink.

Example 2 The topical applicator in this example of the invention is made of a pea-green polyester urethane plastic spongy material. Its specific gravity is 0.04 and its approximate average pore size is 1.5 mm.

Example 3 Four sponges in the size of %"x2 /2"x2 /z were prepared, one each'from polyether urethane plastic, polyester urethane plastic, cellulose sponge and rubber sponge. The sponges used were of the finest pores available for size. 1

Each sponge was moistened with 4 cc. of water. Subsequently, A1. cc. of a liquid, containing p-triisopropylphenoxypolyethoxyethanol and 8% sodium lauryl sulfate was applied to each side of each sponge and then the sponge in each case was gently compressed and expanded as often as possible to develop the most foam that could be developed therefrom.

With the polyester and polyether sponges, each weighing 0.8 gram, a voluminous foam amounting to over 25 cc. was developed with gentle manipulation and pressure. With the cellulose sponge, weighing 2 grams, less than 10 cc. of foam exuded to the surface even when considerable pressure and manipulation was applied. The rubber sponge weighed 4 grams; about 7 cc. of foam were developed after considerable manipulation and pressure. Less than half the pressure was required to deform the polyester or polyether urethane sponges and cause foam to be released than was required to deform the rubber or cellulose sponges to the same degree.

The above disclosed embodiments and examples were not exclusive embodiments and examples of the invention, therefore, the scope thereof is to be interpreted from the appended claims.

What I claim is:

1. A topical applicator for vaginal insertion, comprising a porous flexible and elastic body made of a polyurethane foam material, said body having a network distributed at random therein, the apparent specific gravity of said body being between 0.01 and 0.04, and the average distance between opposing sidewalls not exceeding 1.5

mm., said applicator further including a foam producing material between said sidewalls.

2. An applicator for vaginal insertion according to claim 1 wherein said body is made of a polyether urethane sponge material.

3. An applicator for vaginal insertion according to claim 1 wherein said body is made of a polyester urethane sponge material.

4. A process for applying a topical agent in the'vaginal cavity, comprising the steps of impregnating a cellular sponge of polyurethane plastic with a foam producing agent, said cells in the sponge forming a network distributed at random and having sidewalls whose opposing faces are spaced from each other at a distance of up to 1.5 mm., producing foam from said agent within said applicator, and placing the foam filled applicator into a I vaginal cavity.

References Cited by the Examiner OTHER REFERENCES Stone et al., In Human Fertility, 10 (3) pp. -73, September 1945.

Hoppe, Kunstsofie, vol. 42, No. 12, December 1952,

Rogers, T. H., Elastomeric Cellular Materials II, in Rubber World, 132(1)), pp. 753-757, September 1955.

RICHARD A. GAUDET, Primary Examiner.

FRANK CACCIAPAGLIA, ]R., Examiner. E. FRANK, C. F. ROSENBAUM, Assistant Examiners.

Claims (1)

1. A TOPICAL APPLICATOR FOR VAGINAL INSERTION, COMPRISING A POROUS FLEXIBLE AND ELASTIC BODY MADE OF A POLYURETHANE FOAM MATERIAL, SAID BODY HAVING A NETWORK DISTRIBUTED AT RANDOM THEREIN, THE APPARENT SPECIFIC GRAVITY OF SAID BODY BEING BETWEEN 0.01 AND 0.04, AND THE AVERAGE DISTANCE BETWEEN OPPOSING SIDEWALLS NOT EXCEEDING 1.5 MM., SAID APPLICATOR FURTHER INCLUDING A FOAM PRODUCING MATERIAL BETWEEN SAID SIDEWALLS.