Dec. 16, 1958 w. c. MENDEV 2,864,367
APPLICATOR Filed NOV. 16, 1955 INVENTOR WILLIAM C. MENDE APPLICATOR William C. Mende, Neshanic, N. J., assignor to Ortho Pharmaceutical Corporation, a corporation of New Jersey Application November 16, 1955, Serial No. 547,235
2 Claims. (Cl. 128-261) This invention relates to devices for dispensing fiowable, 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 formulation 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 operation 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. Another disadvantage of these devices has been the diifi culties 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 number 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, efiicient, simple and economical applicator for use 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 immediately 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;
Figure 3 is a side elevation of the applicator of Figure l 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;
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.
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 I having a dispensingtube 2 communicating with its contents. The container is constructed of resilient or elastic mate- United States Patent '0 F 2,864,367 Patented'Dec. 16, 19 58 lar or neck on the container over which or within whichtube 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 mate rials 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 anorifice 6. The tip portion, preferably constructed of the same material as the tube itself, may also be made removable from thetube body 2 or may be formed integrally with the tube.
In the operation of the device, dispensingtube 2 is held at a level lower thancontainer 1; therefore, provision is made to prevent the container contents from flowing freely throughorifice 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 aspring 16 which has sufiicient 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. I
in Figure 2, there is shown container walls8 and 9 disposed opposite each other. On wall 8 aprotuberance 10 extends a predetermined distance in thedirectionof wall 9 from the plane ofwall 8, but does not touchwall 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 withwall 9 in the compressed state of the device and provide a series of applications of substantially equal volume.
Thedistance protuberance 10 extends from the plane ofwall 8 towardswall 9 is predetermined in order that a selected quantity of the container contents may be discharged. Figure 3 shows the position of thecontainer walls 8 and 9 at the limit of their displacement towards each other. Further compressibility of the Walls is unobtainable whenwall 9 contacts the tip ofprotuberance 10. When the walls are so compressed, the container contents 11 are discharged throughorifice 6 at the locus of application.
Protuberance 10 is shown on the drawings as having a relativelyfiat 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 applica fitins because this "configuration affords sulficient 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 theangle 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 de- 'creased. Conversely, to decrease the delivered dosage, the height is increased. Another method of establishing the quantity delivered is by varying the dimension of the container itself.
In another form of the invention, as shown in Fig. 5. each of a pair of oppositely disposedwalls 8 and 9 may -be provided withprotuberances 10 and it) aligned so -they will contact each other at their tip portions whenWalls 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 difiiculty may be overcome by providing an opening 13 at the end 14'of the container oppositetube 2 and by position ing 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 compression 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 throughorifice 6 in the dispensing tube 7- 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 thatcontainer 1 is at a level higher thantube 2. When the applicator is held inthis 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 wail having the protuberance on its inner surface at the site of the protuberance and the wall disposed oppositely and 'contlnued until there is no further wall displacement.
When this position is reached, as shown in Figure 3, a
prescribed dosage will have been discharged throughorifice 6. Release of pressure on the walls permitsthe 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 withtube 2 abovecontainer 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.
I claim as my invention:
1. A device for dispensing a plurality of applications of a liquid therapeutic formulation contained therein comprising: a resilient container, one wall thereof having a substantially centrally located, relatively fiat-tipped protuberance on its inner surface extending part way towards the op osing wall of the container; a tube communicating with the container contents attached to a surface area other than that having the protuberance on its surface, the tube having a valve positioned at its tip portion opening on compression of the container walls for discharge of the container contents and closing on release thereof to prevent the container contents from flowing freely through said orifice when said device is inverted.
2. A device for dispensing a plurality of applications of a liquid therapeutic formulation contained therein comprising: a resilient container, one wall thereof having a substantially centrally located, relatively flat-tipped protuberance on its inner surface extending part way towards the opposing wall of the container; a tube communicating with the container contents attached to a surface area other than that having the protuberance. the tube having a valve positioned at its tip portion opening on compression of the container walls for discharge of the container contents and closing on release thereof; a valve positioned at the end of the container substantially opposite the dispensing tube, said valve closing on compression of the container walls and opening on release thereof.
References Cited in the file of this patent UNITED STATES PATENTS 1,806,517 Bellows May 19, 1931 1,991,278 Heintz et al. Feb. 12, 1935 2,066,868 Whittaker Jan. 5, 1937 2,080,427 McLaughlin May 18, 1937 2,688,424 Keiter Sept. 7, 1954 2,761,833 Ward Sept. 4, 1956