Fluid unit dispensing device

A flexible unit dispensing device for a fluid comprising a squeezable hollow bulb portion and a cylindrical nozzle. The internal diameter of the nozzle is no smaller than 0.120 inches and the length of nozzle being such as to reach to the area of the rectal columns when the device is inserted in the anal canal.

This invention relates to a dispensing package suitable for delivering a 
fluid product into the anal canal. This is useful in, but not restricted 
to, the delivery of therapeutic liquids or creams for the treatment of 
hemorrhoids. 
In the treatment of hemorrhoids, the regimen often calls for the 
self-administration of liquids or creams into the anal canal. This has 
presented several problems. In the first place, self-access to the anal 
canal is difficult, making it a problem to conveniently apply sufficient 
pressure to the dispenser so that it can be adequately emptied and deliver 
to the affected area the required amount of medicament. Secondly, the 
proper therapeutic treatment often times calls for the deposition of the 
medicament at the appropriate level in the anal canal; that is, at the 
level of the affected hemorroidal tissue. Thirdly, since the tissue under 
these conditions is often inflamed and painful, it is necessary to deliver 
the medicament with a minimum of manipulation. 
It has now been found that the above described problems can be handled by 
providing a unit dosage dispenser in the form of a squeezable or flexible 
bulb having a nozzle of sufficient length to reach the affected areas in 
most cases of hemorrhoids and of such dimension as to make the delivery of 
the medicament possible with the application of a minimum of pressure and 
to make the insertion possible with a minimum of discomfort. 
It is accordingly an object of the present invention to provide a unit 
dosage dispenser having the characteristics described above.

Referring now to the drawings in which the same number designates the same 
structure in the various views, a dispenser embodied in the present 
invention is shown generally at 2 and comprises a bulb portion 4 and a 
nozzle 6. Bulb portion 4 on its interior comprises a hollow single chamber 
8 which tapers gently to form a cylindrical nozzle canal 10. As will be 
seen by a comparison of FIGS. 2 and 3, the external configuration of bulb 
portion 4 and nozzle 6 follow generally the shape of bulb chamber 8 and 
nozzle canal 10. 
Removably secured to the end of nozzle 6 there is provided a break-off tab 
12 which serves to seal off the end of nozzle canal 10. Break-off tab 12 
is preferably secured to the end of nozzle 6 so that it may be readily 
removed by a twisting motion. 
Bulk portion 4 of dispenser 2 is provided with a finger tab 14. This serves 
to facilitate the handling of the dispenser when it is to be inserted into 
the anal canal. 
It is a feature of the present invention to minimize the discomfort that 
the user of this device may encounter. When the break-off tab 12 is 
removed, there is the potential that rough edges may remain at the nozzle 
end which would tend to cause pain when the dispenser is inserted into the 
anal canal. 
To avoid this, a construction is employed which is best illustrated in the 
enlarged detailed view shown in FIG. 6. As will be seen in this drawing, 
the upper margin of nozzle 6 is rounded off to provide a smooth curved 
surface 18 that extends down into the nozzle orifice 20. In addition, the 
bottom portion of break-off tab 12 is provided with a step 16 which is 
joined to nozzle 6 inside nozzle orifice 20. As a consequence, when 
break-off tab 12 is removed from the nozzle 6 as by a twisting motion, the 
roughened fracture line is within the nozzle orifice and out of any 
position which might tend to irritate the tissue when the dispenser is 
inserted into the anal canal. 
The dispensing device of the present invention containing product can be 
formed in several ways. One procedure involves first forming by way of 
blow molding technique, a semi-finished unit in which the break-off tab 
12, nozzle 6, and an open-ended tubular portion are molded as a unit. This 
semi-finished piece is then loaded through the bottom with, for example, 
the medicated cream and sent on to a forming and sealing station at which 
the formation of bulb 4 is completed, finger tab 14 is formed and the 
device is sealed. This is accomplished with material from the tubular 
portion of the semi-finished unit. 
In a second procedure, an upper tubular section, bulb portion 4 and finger 
tab 14 are blow molded as a single unit. The medicated cream is then 
loaded into the device through the upper tubular opening. In a manner 
similar to the prior procedure, break-off tab 12 and nozzle 6 are formed 
and the device is sealed in a single forming and sealing step using 
material from the upper tubular section. 
The present dispenser is inteded to take the form of a squeezable or 
flexible device. Any of a variety of materials may be used in molding this 
dispenser to get these characteristics. However, in the preferred form of 
the invention, the dispenser is molded of low density polyethylene. 
As previously indicated, certain dimensional parameters of the present 
dispensing device are essential for obtaining a dispensing device that 
will deliver medication conveniently to the affected hemorrhoidal tissue 
at a minimal pressure and with a minimum of discomfort. One of such 
parameters is the internal diameter of the discharge orifice of the nozzle 
after the break-off tab has been removed. It has been found that to 
accomplish the present purposes, this diameter should not be smaller than 
about 0.120 inches. This controls the discharge pressure and gives an 
adequate product flow rate. 
A second critical dimensional parameter is the length of the cylindrical 
tapered nozzle 6. This needs to be long enough to pass through the 
internal sphincter muscles of the anal canal and into the area of the 
rectal columns which are usually swollen and inflamed when the subject is 
suffering from hemorrhoids. It has been found that the appropriate length 
of the tapered nozzle to deliver the medicated material to the appropriate 
place is about 15/8 inches. 
The bulb portion 4 of the dispenser has to be fashioned with two thoughts 
in mind. It needs to be designed to act as the external sphincter muscles 
so as to prevent total entry of the device into the anal canal. Secondly, 
it needs to provide an adequate pressing area for the thumb and forefinger 
for dispensing the product into the hemorrhoidal region. It has been found 
that a bulb having a greatest diameter of about at least 0.750 inches very 
adequately serves the present purposes. 
The outside diameter of the nozzle 6 is controlled to provide the smallest 
device which can be comfortably inserted into the anal canal and at the 
same time, allow for good distribution and coating of the medicated 
product on the rectal columns. This may vary somewhat but a suitable 
diameter is 0.240 inches. 
The height of step 16 is also selected to insure that any rough edges 
remaining on nozzle 6 resulting from the removal of the break-off tab 12 
are inside the neck of nozzle 6 and not outside where they could cause 
irritation. A step height of about 0.030 inches has been found to be quite 
suitable. 
Break-off tab 12 is designed to provide an adequate area for gripping it 
with the forefinger and thumb so that an adequate force can be applied to 
break off this tab. In a preferred form of this invention, the width (i.e. 
the horizontal dimension) is about 0.625 inches; whereas, the height (i.e. 
the vertical dimension) is 0.500 inches. 
Finger tab 14 is designed for ease of handling of the dispenser when it is 
being self-administered. Its dimensions can vary somewhat. A finger tab 
that has a vertical dimension of 0.500 inches and a horizontal dimension 
of 0.750 inches has been found to be quite adequate. 
The overall dimensions of the present dispenser i.e. its maximum vertical 
dimension and its maximum horizontal dimension may also vary somewhat. 
Ordinarily, it will be designed to hold about 5 grams of product so as to 
assure a delivery of at least 3 grams of product to the affected area. A 
device that had an overall vertical dimension of 3.625 inches and a 
horizontal dimension of 0.750 inches has been found to be quite suitable. 
To allow for machine filling and to provide a delivery of a minimum of 3 
grams of product, the product is introduced into the dispenser to a level 
of about 2.187 inches from the bottom of the bulb chamber. Although this 
can vary somewhat, this has proven to be a very convenient level. 
Although the invention has been described with reference to specific forms 
thereof, it will be understood that many changes and modifications may be 
made without departing from the spirit of this invention.