Note: Descriptions are shown in the official language in which they were submitted.
wo 94/20379 ~ 7 ~ 2 ~ PCT/US94/0216~
TITLE OF THE INVENTION
SINGLE USE FLUID DISPENSING DEVICE
BACKGROUND OF THE INVENTION
A significant problem with previous devices for dispensing
liquid medications topically is that they are bulky, cumbersome, contain
many parts, are not easily carried in a handbag or pocket, and are
expensive to make. Additionally, the devices are generally designed for
multiple applications or reuse which increases the potential for
cont~min~tion and/or aging of the liquid medication through long te~n
use.
Unlike the previous devices the instant invention is a single
use dispensing device designed for easy handling during application,
15 easy twist-off/no tool opening, low cost and good distribution of the
drug onto the subject being medicated.
SUMMARY OF THE INVENTION
A single use fluid dispensing device is provided with a
20 bottle of suitable plastic material whose walls are convexed and a
dispensing lid which consists of one or more extended outlets (nozzles)
with openings, through which liquid is uniformly distributed. The
openings are sealed until immediatly before the device is to be used and
result from the removal of break-off tabs, which act as a leakproof seal
25 until the device is opened. The shape of the bottle as well as ~e
presence of internal cores, one or more internal ribs, or indented
dimples detellnilles the amount of liquid that is dispensed per pump
stroke (full squeeze) of the bottle. The extended nozzles provide a
means to get beneath the fur of an ~nim~l to apply the liquid medication
30 directly to the skin. The outlets can be flow restricted by well known
means, such as limiting the size of the opening, to also limit pump
stroke volume.
Thus it is an object of the present invention to provide a
single use fluid dispensing device that conveniently meters out its
contents in several small controlled doses. Another object of the instant
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invention is to describe how the pump stroke volume is limited. Still
another object of the invention is to provide a single use fluid dispensing
device having a convexed body, internal cores, ribs, or indented
dimples. Still another object of the invention is to provide a single use
fluid dispensing device having nozzles which are flow restricted. These
and other objects of the present invention will be apparent from the
following description.
BRIEF DESCRIPTION OF THE DRAWINGS
For a more complete understanding of the invention,
reference should be made to the embodiments illustrated in greater
detail in the accom~allying drawings.
15 In the Drawings:
FIG. 1. is a perspective view of the dispensing device,
wherein the walls of the bottle are convexed.
FIG. 1 a. is a perspective view of the dispensing device of
FIG. 1, viewed before the dispensing lid is attached
to the bottle.
FIG. 2. is a perspective view of the dispensing device
positioned for dispensing liquids without the break-
away tab.
FIG. 3. is an enlarged cross-sectional view of a nozzle with
the break-away security tab attached.
FIG. 4. is a perspective view of an alternative embo-limPnt
of the invention, wherein the bottle contains
internal cores and also shows the break-off tab
3 o being removed for use of the device.
FIG. 5. is a perspective view of an alterllative embodiment
of ~e invention, wherein the bottle contains
internal ribs.
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FIG. 6. is a perspective view of an alternative embodiment
of the invention, wherein the bottle contains
indentations or indented dimples.
FIG. 7. is an illustration of the mechanism used to limit the
pump stroke volume in FIG 1, wherein the curved
walls of the bottle goes from convex, to flat and
then to concave.
FIG. 8. and 16 are perspective views of variants of the
dispensing device having convexed walls with
slightly different break-away tabs and adapted for
large or smaller volume capacity.
FIGS. 9 and 13 are the top plan views of the device of
Figures 8 and 16.
FIGS. 10 and 14 are the front elevational views thereof;
FIGS. 1 1 and 17 are the side elevational views thereof;
FIGS. 12 and 18 are the bottom plan views thereof.
It should be understood that the drawings are not
necessarily to scale and that the embodiments are sometimes illustrated
by graphic symbols, phantom lines, dia~ lic representations and
fragmentary views. In certain instances, details which are not necessary
for an understanding of the present invention or which render other
details difficult to perceive may have been omitted. It should also be
understood, of course, that the invention is not necessarily limited to the
particular embodiments illustrated herein, and that optimum
dimensional relationships include variations which are readily apparent
and obvious to one skilled in the art and that all equivalent relationships
to those illustrated in the drawings and described in the specification are
inten(led to be encompassed by the present invention.
DETAILED DESCRIPTION OF THE INVENTION
This invention consists of a single use fluid dispensing
device, which is intended for delivery of sterile fluids in 4 to 7 pump
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strokes for ~lmini~tration to any bodily surface, or intended for
~lmini~tration to the eye (ophth~lmic fluids).
The dispensing device of the present invention has a sealed
reservoir end for cont~ining liquids and a dispensing end with one or
5 more extended nozzles in a coplanar arrangement. Each of the nozzles
has at least one opening for dispensing liquid and each opening is sealed
by a removable sealing means. The reservoir end has paired inwardly
deformable flexible side walls oppositely arranged which can be
deformed by an inwardly applied force and reformed by releasing the
force. The deformation is limited by pump stroke limiting means,
whereby a full deformation of the side walls yields a fractional
expulsion of the total liquid contents out of the nozzlles and openings.
A key feature of this invention is its ability to conveniently
meter out its contents in several small uniform doses (i.e., Multi-point
Applicator-referring to the number of squeezes), which is achieved
through a variety of mechanical displacement means, each of which may
be used alone or in combination with each other. T~e pump stroke
limitin~ means are based on the fact that liquid is expressed from
20 extended outlets (nozzles) through the squeezing action on the flexible
bottle which causes a volumetric displacement within the bottle. The
amount of liquid expressed from the nozzles is directly related to the
volumetric displacement of the bottle. By limiting the amount of
displacement per stroke the volume of liquid expressed per stroke is
limited.
In the present invention, displacement is preferrably
limited by one of three ways. The first way is to add internal ribs or
cores (see figures 4 and 5) to the interior of an injection molded flat or
curved outer surface bottle. At a predetermined distance from the as-
30 molded position of the bottle walls, the squeeze action encounters anobstruction caused by ~e contact with solid ribs on the opposing side or
cores within the bottle. This obstruction limits fur~ler squeezing. The
user will then release the applied compressive load, which allows the
bottle to return to its original shape, and prepares the applicator for its
next stroke. The factors which affect the number of strokes/unit dosage
WO 94/20379 21~ ~ 0 2 6 PCT/US94/02168
are height, quantity and geometry of the ribs, orifice size in the nozzles,
geometric shape of the bottle and the modulus of elasticity of the plastic
resin.
The .second way for limiting stroke in the squeeze bottle of
the present invention is through the use of molded-in dimples or
indentations (See Figs. 6a and 6b). In this embodiment, the indentation
acts the same as the rib or core in limiting the mechanical stroke of the
bottle.
The third and most preferred means of stroke limit~tion
uses a combination of the geometric shape of the bottle, mechanical
properties of the polymeric resin, and to a certain extent hydraulic back
pressure to limit the ~u~ lg stroke (See Figs. 1, 8 and 16). For
illustration purposes only, the assumption will be made that the wall of
the bottle acts as flat plates fixed on four edges. For small deflections
of this plate caused by force applied to the center of the plate, the
resistance to deflection is caused mostly by the bending stresses at the
support. As the amount of deflection increases, membrane (tensile)
stress become more significant, greatly increasing the force necessary to
deflect the plate further. This increase in resistance due to the
mechanical properties of the plastic is additive to the back pressure
generated by the hydraulic resistance of the liquid being forced through
the orifices in the nozzles.
In this preferred embodiment, the walls of the bottle are
not flat, but curved with a specific radius so that the squeeze stroke
begins with the walls convex, passing through flat, and then concave.
See Figure 7. By controlling the curvature in this m~nnfr, the amount
of volume displaced before high forces set in can be controlled. In
general, decreased radius (more convex) will increase stroke while
increasing radius (more flat) will decrease stroke.
Another key feature of this invention is the presence of one
or more nozzles, each extending sufficiently from the bottle to allow
easy access to the skin below the ~nim~l,s fur, thereby providing a
"comb effect" when m~kin~ multi-point applications. To fulfill the
function of getting underneath the hair of the ~nim~ls the nozzle should
WO 94/20379 2 1~ 7 ~ 2 ~ PCT/US94/02168--
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be 1/3 to 2 inches (O.S to 5 cm) in length depending upon the length of
the hair and spacing of the nozzles. The distance between the nozzles
can range from 1/4 of an inch to 3 inches (0.5 to 8 cm), preferably 0.5
5 to l inches (1 to 3 cm). The size of the openings in the nozzles is
another means of limilin~, the volume displaced when using the device.
The fluid dispensing device 8 of the present invention
varies in size and geometric shape and can be formed from a variety of
materials such as, for example, soft or hard plastic, e.g., polypropylene,
low density polyethylene, high density polyethylene, or other m~nll~lly
deformable material. The dispensing device 8 can be produced in one
or two pieces by conventional blow molding, injection molding,
thermoforming, or various form fill seal technologies. It is to be
understood that the device of the present invention is not limited to its
15 manufacture by any specific process as it will be understood by those
skilled in the art that many different manufacturing techniques can be
employed.
The ~refelred embodiment of the present invention consists
of Bottle 10 shown in Figures 1, 8 and 16, made of a suitable plastic
20 material, has walls that are convexed to create limited pumping action
and stiffness, (stiffness refers to the ability of the device to resist
deflection under load) and is adapted to contain a liqllid medication,
preferrably a physiologically acceptable, topical liquid antiparasitic
medication. The neck of bottle 10 has a flange lOa which is
25 complimentary in shape to the bottom of dispenser lid 12. Dispenser lid
12 consists of a base 16 and nozzles 14a and 14b which are positioned
on the topside of base 12a. The nozzles are generally parallel and each
contains one or more orifices, preferrably one, through which liquid is
dispensed. The openings range from 0.010 - 0.040 inches in diameter
30 (0.2 to 1.0 mrn), preferrably 0.025-0.035 inches in diameter (0.6 to 0.9
mm) and are created when break-off security tab 18 is m~nl-~lly twisted
or broken off. The openings are the result of controlled rupturing of
the plastic material. Bottle 10 is attached to dispenser lid 12 by
thermally sealing flange lOa and ~e bottom portion of base 16 together.
wo 94/20379 2 15 7 0 2 G PCT/US94/02168
Alternatively, dispensing device 8 can be produced as a single unit so
that the dispenser lid is integral with bottle 10.
In another embodiment of the present invention shown in
Figs. 4 and 5 bottle 20 has internal cores 20a which are interposed in
the bottle or one or more internal ribs 20b which are positioned on at
least one wall of the bottle to limit the stroke in the bottle when it is
squeezed.
In still another embodiment of the invention shown in Figs.
6a and 6b consists of a bottle which is produced with dimples or
indentations 30a to limit stroke volume.
The liquid medication can be added to the container in
several ways which would be obvious to one skilled in the art. For
example, the liquid can be added to the bottle prior to thermally sealing
15 the dispenser lid 12 to bottle 10; it can be added through one of the
openings in the nozzle before se~lin~ the openings with the break-off
security tab; or it can be added through a fill spout 40 (Fig. 6a) in the
bottle which is then thermally sealed.
In accordance with the present invention the single use
20 dispensing device provides a means to get beneath the fur of an ~nim~l
and express the entire liquid contents of the bottle in several small
doses. The device is utilized by bre~king or twisting off the break-off
security tabs, positioning the container with the nozzle openings facing
downward toward the ~nim~l beneath the fur of the ~nim~l's skin and
25 applying from about 15% to 25%, ~refe.,ably 20%, of the total liquid
medication to the skin of the ~nim~l with each pump stroke (full
squeeze) of the bottle until the entire contents of the bottle has been
dispensed.
After application of the medication, the empty container
will be discarded. There is no provision of this delivery device to be
recapped, refilled, resealed, or reused after opening, since it is a single
use applicator. There is also no stand-up requirement for this
dispensing container.
