Applicator

Dec. 16, 1958

2,864,367

W. C. MENDE

APPLICATOR

Filed Nov. 16, 1955

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2,864,367

Patented Dec. 16* 1958

United States Patent Office

2,864,367

APPLICATOR 5

William C. Mende, Neshanic, N. J., assignor to Ortho Pharmaceutical Corporation, a corporation of New Jersey

Application November 16, 1955, Serial No. 547,235 jo

Claims. (Cl. 128—261)

This invention relates to devices for dispensing flowable, 15 such as viscous liquid, therapeutic formulations into body cavities and, more particularly, relates to a device for repeatedly dispensing a plurality of measured applications of the container contents.

Before a prescribed quantity of a therapeutic formula- 20 tion can be administered with the usual devices of this nature, it is often necessary to attach the device to a collapsible tube, or similar container, and transfer the container contents, as by squeezing, into the device. Generally, this method of filling and the subsequent opera- 25 tion of the device in applying the therapeutic formulation requires manual manipulation of moving parts, such as a plunger, a piston, or the like. In the interim between applications, these devices are often subject to sticking of the moving parts because of drying out of the contents. 30 Another disadvantage of these devices has been the difficulties attending self-administration, particularly where visual observation is not feasible.

An object of this invention is to provide an applicator which is immediately available for delivering a num- 35 ber of measured applications with a minimum of operation and having no parts which can be frozen by drying out of the container contents.

Another object of this invention is to provide a practical, efficient, simple and economical applicator for use 40 in self-administering a therapeutic formulation and requiring no visual observation during administration.

A further object of this invention is to provide a device which will discharge a measured quantity of its contents solely by the application of pressure and will be immedi- _4gately available for subsequent applications.

These and other objects and advantages will appear from the following description and the accompanying drawing wherein like numerals of reference designate like parts throughout the corresponding views and in which:

Figure 1 is an isometric view of the assembled applicator;

Figure 2 is a side elevation of the applicator of Figure 1 showing part thereof in cross-section; _sg

Figure 3 is a side elevation of the applicator of Figure 1 with the walls of the applicator body compressed and also showing part of the applicator in cross-section';

Figure 4 is a sectional view of the container part of the applicator provided with a valve at one end; _gg

Figure 5 is a sectional view of the container part of the applicator, and illustrates another embodiment of the invention; and

Figure 6 is an elevation, partly in section, of the tube part of the applicator provided with a valve. _g5

This invention broadly consists of a resilient container having walls limited in displacement towards each other, the extent of displacement being correlated with the amount of the container contents to be dispensed.

The applicator consists generally of a container 1 having a dispensing tube 2 communicating with its contents. The container is constructed of resilient or elastic mate2 rial, such as rubber, synthetic elastomeric materials, or high molecular weight polymers such as polyethylene, polyvinyl chloride and the like, which permits the container to return to its original configuration when deforming pressure on the container walls is released. The container, although shown in the preferred rectangular form, can be of a variety of shapes, such as ovoid, square, cylindrical, or spherical. Tube 2, communicating with the contents of the container may be removably attached thereto by any suitable means such as by providing a collar or neck on the container over which or within which tube 2 is secured. In one form of the invention, as shown in Figure 2, the tube is enlarged in diameter at 3 to the extent necessary to fit snugly over collar 4 of the container. It is possible to decrease the diameter at 3 to fit within the collar 4. Other well-known conventional means of securing the tube to the container are equally suitable. Alternatively, the tube and the container may be integrally formed. It is necessary that the dispensing tube be attached to the container at a surface area other than a surface area which has a protuberance on its inner surface. The tube can be constructed of the same materials that are used in the container. Particularly suitable are the high molecular weight polymers, such as polyethylene, since they are easy to clean' and are relatively flexible and non-fragile. The length of the tube is established by the depth to which it is to be inserted into the particular body cavity being treated, and for vaginal use, it is preferably five to six inches in length. The end of the tube is provided with a tip portion 5 having an orifice 6. The tip portion, preferably constructed of the same material as the tube itself, may also be made removable from the tube body 2 or may be formed integrally with the tube.

In the operation of the device, dispensing tube 2 is held at a level lower than container 1; therefore, provision is made to prevent the container contents from flowing freely through orifice 6 when the device is inverted by correlating the size of the orifice with the viscosity of the container contents to effect substantial retention thereof. Alternatively, the tip portion may be provided with a ball valve 7 held in position by a spring 16 which has sufficient tension to permit the ball valve to unseat when the container is squeezed and the contents ejected. Other suitable means which open to permit discharge of the contents when the container walls are compressed and close when compression is released may also be employed.

In Figure 2, there is shown container walls 8 and 9 disposed opposite each other. On wall 8 a protuberance 10 extends a predetermined distance in the direction of wall 9 from the plane of wall 8, but does not touch wall 9 when the container walls are in an uncompressed state. The protuberance may be cylindrical, as shown, or hemispherical, or may be of a variety of shapes which allow it to come into contact with wall 9 in the compressed state of the device and provide a series of applications of substantially equal volume.

The distance protuberance 10 extends from the plane of wall 8 towards wall 9 is predetermined in order that a selected quantity of the container contents may be discharged. Figure 3 shows the position of the container walls 8 and 9 at the limit of their displacement towards each other. Further compressibility of the walls is unobtainable when wall 9 contacts the tip of protuberance 10. When the walls are so compressed, the container contents 11 are discharged through orifice 6 at the locus of application.

Protuberance 10 is shown on the drawings as having a relatively flat surface 12 on its tip portion; this is the. preferred configuration of the protuberance since this provides the most uniform volume for a series of applies2,804,367 .-.. ³ 'Irons because this configuration affords sufficient area -of contact -between the tip of the protuberance and the opposing wall; or, as in another form of this invention illustrated below, sufficient area of contact between 'aligned^; protuberances on a pair of opposed walls to prevent deviations in the angle of contact between the contacting surfaces. With only a small area of contact, the possibility of volume variance is enhanced.

To increase the delivered dosage in a container of an established size, the height of the protuberance is decreased. Conversely, to decrease the delivered dosage, the height is increased. Another method of establishing the quantity delivered is by varying the dimensions of the container itself.

In another form of the invention, as shown in Fig. 5. ; each of a pair of oppositely disposed walls 8 and 9 may • be provided with protuberances 10 and 10' aligned so -they will contact each other at their tip portions when walls 8 and 9 are compressed. These protuberances may . be of the same configuration as in the case of the container having one wall with a protuberance as shown in Figures 2 and 3.

Viscous formulations in the nature of semi-liquids and jelly-like substances flow slowly into the tube and lower portion of the container and, unless the formulation to be dispensed fills the tube, substantially accurate measured quantities are not delivered. This difficulty may be overcome by providing an opening 13 at the end 14 of the container opposite tube 2 and by positioning a valve 15 (Fig. 4) at the opening; a valve, such as the illustrated flutter valve, which closes when the container walls are compressed and opens when com pression is released, is satisfactory.

After a measured quantity has been delivered, the . applicator is retained in its inverted position, pressure on the container walls is released, air rushes into the . container carrying the remaining contents down into the tube and the lower portions of the container so they are immediately available for use. If valve 15 is not present, the only means for the entry of air is through orifice 6 in the dispensing tube 2 which is filled with the relatively viscous semi-liquid or jelly. The container resists returning to its normal state since a partial vacuum is created. This problem is not present in free-flowing liquids or semi-liquids and, accordingly, no valve assembly is necessary when the device is used for dispensing such materials.

In the operation of the device, tube 2 is inserted into a body cavity and held in a position so that container 1 is at a level higher than tube 2. When the applicator is held in this manner, the contents fill the tube and the lower portions of the container by gravity. Inward pressure is then applied on the outer surfaces of the wall having the protuberance on its inner surface at the site of the protuberance and the wall disposed oppositely and continued until there is no further wall displacement.

When this position is reached, as shown in Figure 3, a prescribed dosage will have been discharged through orifice 6. Release of pressure on the walls permits the container to assume its original shape. Should a second or subsequent application be required, the process may be repeated without removal or refilling of the device. When the required quantity of the therapeutic formulation has been administered, the applicator is then removed from the body orifice, the outer surface of the dispensing tube is cleaned and the entire unit is stored, preferably with tube 2 above container 1. For storage purposes, the applicator can be provided with a cap to fit over the tip portion of the tube or with a cap extending over the entire length of the tube.

It is apparent that various modifications may be made without departing from the spirit and scope of the present invention. This application is a continuation-inpart of my copending application Serial No. 319.389, “Applicator,” filed November 7, 1952 and now abandoned.