Note: Descriptions are shown in the official language in which they were submitted.
<IMG>
CA 02326195 2000-09-27
WO 99/51509 PCT/IJS99/06871
2
OBJECTS AND SUMMARY OF THE INVENTION
Accordingly, it is a principal object of the present invention to provide a
package for storing and dispensing measured amounts of a fluid or flowable
product, particularly a medicinal agent which has been introduced to an
absorbent material prior to application.
An additional object of the present invention is to provide a package for
storing and dispensing measured amounts of a fluid that is easy to use and
has a relatively long shelf life.
And still a further object of the present invention is to provide a
package for storing and dispensing measured amounts of at least two
different fluid products wherein the products must be mixed in measured
amounts prior to subsequent use or application.
Still another object of the present invention is to provide a versatile
package for storing and dispensing measured amounts of a medical product
that is reusable or can be varied in the amount of product dispensed.
Additional objects and advantages of the invention will be set forth in
part in the foltowing description, or may be obvious from the description, or
may be learned through practice of the invention.
In accordance with the objects and purposes of the invention, a
package is provided for storing and dispensing measured amounts of a fluid
product. In one preferred embodiment of the invention, the measured amount
of fluid product is first introduced to an absorbent material carried in the
package, wherein the package is then opened for access to the absorbent
material with the fluid product carried therein. In this embodiment, the
package includes a first section having at least one compartment with at least
a first fluid product stored in this compartment. A second section is
separated
from the first section by a first breakable seal, for example a frangible
wall,
wherein the fluid product can move through the seal into the second section
upon compression of the first compartment. The second section stores the
absorbent material that absorbs the fluid product. Means are provided for
accessing the second section, such as a perforated or scored tear tine, so
that the absorbent material can be subsequently removed from the package
CA 02326195 2000-09-27
WO 99/51509 PGT/US99/06871
3
after introduction of the fluid product into the second section for
application
and final use of the product.
The first and second sections may be defined between opposite
flexible sheets of material with sealed peripheral edges. In this embodiment,
the breakable seal divides the space between the sealed flexible sheets into
the first and second sections. The breakable seal rnay comprise a frangible
wall member disposed between the inner facing surfaces of the flexible
sheets. In this embodiment, the frangible wall is formed of a material having
a rupture point that is less than that of the flexible sheets whereby upon
compression of the first section, the frangible wall ruptures allowing the
flowable product to be introduced into the second section. The frangible wall
can be formed from a thinner sheet of the same material as the flexible
sheets, or may be formed from a different material.
In still a further embodiment, the first section may comprise an
additional second compartment separated from the first compartment by a
second breakable seal, for example an additional frangible wall. The second
compartment may be used to store an additional fluid product to be mixed
with the first fluid product prior to introduction of the mixed products into
the
second section of the package. In this embodiment, the first section is
compressed in a manner so that the second breakable seal ruptures allowing
the two fluid products to mix. After adequate mixing of the products, the
first
section is again compressed so that the first seal ruptures allowing the mixed
products to flow into the second compartment.
It may be preferred that not all of the fluid product, whether a single
product or mixed products, be introduced into the second compartment. In
this case, it may be preferred to provide a metering device, such as a
resealable valve, in the seal between the first and second sections. In this
manner, a limited desired portion of the fluid product can be controllably
introduced into the second section of the package upon compression of the
first section. Upon release of a compressive force on the first section, the
valve or metering device reseals.
CA 02326195 2000-09-27
WO 99/51509 PCT/US99/06871
4
In an alternative preferred embodiment of the invention, the package is
used to store measured amounts of two separate fluid products, and to
dispense the products in a controlled manner once they have been mixed
within the package. In this embodiment, a first section is provided having at
least one compartment with at least a first fluid product stored in the
compartment. A second section is separated from the-first section by a
breakable seal and contains a second fluid product to be mixed with the first
fluid product. Upon compression of either of the first or second sections, the
breakable seal ruptures and the two fluid products are free to mix or merge.
A sealable port is defined in the package so that the mixed fluid products can
be subsequently dispensed from the package. In a preferred embodiment,
the sealable port is a capped or resealabfe valve defined in the second
section of the package.
The package is thus particularly useful when only a limited amount of
the first fluid product is to be introduced and mixed with the second fluid
product. For example, a valve or metering device may be provided in the
breakable seal so that only a portion of the first fluid product is allowed to
mix
with the second fluid product. This metering device may comprise any
manner of valve or similar device, such as a conventional flap valve. In this
manner, it may be preferred to provide graduation or meter marks on the first
section to accurately determine the amount of first fluid product introduced
into the second section. Likewise, it may also be preferred to include
graduation or meter marks on the second section to accurately dispense only
a measured amount of the mixed fluids from the package.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective view of a preferred embodiment of the
package according to the invention;
Figure 2 is a side view of the package illustrated in Fig. 1 taken along
the lines indicated;
Figure 3 is a perspective view of an alternative preferred embodiment
of the package according to the invention;
CA 02326195 2000-09-27
WO 99/51509 PGT/US99106871
Figure 4 is a side view of the breakable seal incorporating a valve
member taken along the lines indicated in Fig. 3;
Figure 5 is a perspective view of an add~ional preferred embodiment
according to the invention;
5 Figure 6 is a perspective view of a preferred alternative embodiment of
the package according to the invention wherein two separate fluid products
are stored in the package for subsequent mixing prior to dispersion; and
Figure 7 is an alternative view of the package similar to that shown in
Fig. 6.
DETAILED DESCRIPTION
Reference will now be made in detail to the presently preferred
embodiments of the invention, one or more examples of which are illustrated
and described in the drawings. Each example is provided to explain the
invention, and is not meant as a limitation of the invention. For example,
features illustrated or described as part of one embodiment can be used with
another embodiment to yield still a further embodiment. It is intended that
the
present description include such modifications and variations as come within
the scope and spirit of the invention as appreciated by those skilled in the
art.
The presently preferred embodiments of the package according to the
invention are illustrated generally in Figs. 1 through 7. For purposes of
explanation, the invention will be described as it pertains to storing and
dispensing medical products. For example, the fluid or liquid products
described herein may comprise any manner of medicinal ointments, salves,
liquids, etc. Similarly, the absorbent material described herein can comprise
any manner of medical pad, gauze, swabs, sponge, etc. It should be
appreciated, however, that the present invention is not limited to application
in
the medical industry, and has any number of applications in the residential
and industrial fields. The package is described herein as a medical product
for ease of illustration and explanation only.
Referring to the figures, in a preferred embodiment of the invention,
package 10 is constructed from opposing sheets of a flexible, plastic or vinyl
film material. An upper or first sheet 30 is adhered to an opposite or bottom
CA 02326195 2000-09-27
WO 99/51509 PCTNS99/06871
6
sheet 32 around sealed peripheral edges 36. The shape of package 10 is
generally illustrated as rectangular, but can comprise any shape or form. The
flexible sheets of material 30, 32 can be a film of material made of
polyethylene, polypropelene, or polyvinylcloride. However, the material
composition of sheets 30, 32 is not intended to act as a limitation on the
scope of the present invention. Essentially, the sheets can be made of any
one of a number of relatively strong, but pliable materials known and used in
the arts. Also, package 10 is not limited to a flexible or pliable material,
but
can comprise a rigid structure formed of any manner of conventional
materials.
Referring again to the figures, package 10 defines a first section,
generally 18, and a second section, generally 24. First section 18 includes at
least one compartment 20 having a first fluid or liquid product 12 stored
therein. Second section 24 contains a second product stored therein, for
example an absorbent material, generally 16. In the embodiment of Fig. 1,
material 16 is a gauze material. In the embodiment of Fig. 2, absorbent
material 16 is illustrated as a plurality of swabs 64. In the embodiment
illustrated in Fig. 5, absorbent material 16 is illustrated as a sponge 62.
The
present invention is not limited to any particular type of absorbent material,
or
any other type of product stored in second section 24.
Second section 24 is separated from first section 18 by a first
"breakable" seal, generally 26. Seal 26 is "breakable" in that upon a
predetermined compressive force being applied to first section 18, seal 26
opens or breaks under hydraulic pressure caused by the fluid product 12
pressing against the seal. It should be understood that, as explained in
further detail below, seal 26 may also have the capability of resealing upon
release of the compressive force on first section 18.
Referring particularly to Fig. 2, first breakable seal 26 may comprise an
intermediate frangible wall member 38 that is adhered or sealed to oppositely
facing inner surfaces 72, 73 of sheets 30, 32 at seal locations 45, 43.
Frangible wall 38 is formed of a material having a rupturing or breaking point
under hydraulic pressure that is less than sheets 30, 32 and seals 45, 43.
CA 02326195 2000-09-27
WO 99/51509 PCT/US99/06871
7
Frangible wall 38 may be formed as a thin sheet of the same material as
sheets 30, 32, or may be formed from a different material. Thus, referring to
Figs. 1 and 2, upon an operator compressing or squeezing first section 18,
fluid product 12 is forced against frangible wall 38 causing the wall to
rupture
and the fluid product 12 to be introduced into second section 24 to mix with
the product stored therein, for example to be absorbed by absorbent material
16.
In an alternative embodiment of the invention particularly illustrated in
Fig. 5, seal 26 may comprise an intermediate sealed section or portion of
sheets 30, 32. For example, referring to Fig. 5, first section 18 is separated
from second section 24 by a relatively wide intermediate seal 37 of sheets 30,
32. Breakable seal 26 is defined as a relatively narrow seal line between
sheets 30; 32. In this embodiment, upon compression of section 18, seal 26
between sheets 30, 32 ruptures allowing flowable product 12 to be squeezed
or forced into second section 24 between the intermediate seal sections 37.
As used herein, the "seals" can be formed in any conventional process
that is particularly suited for the type of materials used to form package 10.
For example, in the preferred embodiments, the seals are formed by a
relatively strong heat seal. However, any method of sealing the sheets or
materials can be used, such as an RF seal, ultrasonic seal, glue, etc. Such
seals and the process for forming the seals are well known by those skilled in
the art.
Package 10 also includes means 28 for accessing second section 24
after the fluid product 12 has been introduced therein. Any manner of known
seals or accessing means can be utilized in this regard. For example,
referring to Fig. 1, access means 28 comprises a perforated or scored tear
line 48. In this embodiment, an operator simply tears the end portion of the
sealed sheets 30, 32 along line 48 thereby providing access into section 24 to
remove the absorbent material 16. In an alternative preferred embodiment
particularly illustrated in Figs. 3 and 4, access means 28 can comprise a
resealable seal 46. Resealable seal 46 can comprise any conventional
resealable device, such as an interengaging male/female seal, zipper,
CA 02326195 2000-09-27
WO 99/51509 PCT/US99/06871
8
adhesive seal, or the like. The present invention is not limited to any
particular type of resealable seal.
The embodiment wherein package 10 utilizes a resealable seal as the
access means into second section 24 may be particularly useful wherein a
plurality of pieces of absorbent material, such as a plurality of swabs 64
illustrated in Fig. 2, are stored in second section 24. In this embodiment,
fluid
product 12 can be absorbed by all of the swabs 64 at one time. However, the
operator need not remove all of the swabs, but can selectively remove the
swabs as needed with the capability of resealing package 10. Any number of
additional uses of this embodiment of the package are within the scope and
spirit of the invention.
Referring particularly to Figs. 1 and 2, an alternative preferred
embodiment of the invention is illustrated wherein first section 18 comprises
a
second compartment 22 separated from first compartment 20 by a second
breakable seal 44. As described above, seal 44 can comprise any manner of
sealing device or mechanism. In the embodiment illustrated in Fig. 2, second
seal 44 comprises an extension of frangible wall 38 sealed between sheets
30, 32 at seal points 43 and 42. This embodiment of the invention is
particularly useful wherein the end product to be introduced into second
section 24 comprises two or more constituents that must be individually
stored prior to mixing and use thereof. For example, certain ointments,
salves, antiseptic or antibiotic solutions, etc., are formed from mixed
components or agents and have a relatively short effective life once mixed. In
this situation, the ingredients or components can -be separately maintained
and stored in package 10 over a relatively long shelf life, and then mixed
within package 10 just prior to use or application.
Referring again to Fig. 2, the embodiment of the invention wherein two
products are stored within first section 18 is utilized by an operator first
pressing or compressing a forward part of section 18 forcing second fluid
material 14 to rupture or break seal 44. Once seal 44 is broken, products 12
and 14 are free to mix. The operator then again presses or compresses
section 18 causing seal 26 to break or rupture wherein the mixed products
CA 02326195 2000-09-27
WO 99/51509 PCTNS99/0687I
9
are then introduced to the absorbent material 16 within section 24. Seals 26
and 44 can be formed from the same frangible wall member 38, as illustrated
in Fig. 2. However, in this embodiment, the operator must be careful to
compress the portion of first section 18 defining second compartment 22 first
so that the seal 44 will rupture before seal 26. In an alternative embodiment,
however, seal 44 may comprise a frangible wall material having a rupture
point less than that of seal 26 so that seal 44 is ensured to rupture prior to
seal 26 upon compression of any portion of first section 18.
The present invention is particularly useful wherein a known or
measured quantity of fluid product is introduced into first section 18 prior
to
sealing edges 36 defining first section 18. For example, it is often desired
or
prescribed to use only a limited amount of antiseptic or antibiotic solution
on a
given area of a patient at any given time. In this situation, the prescribed
or
desired amount can be pre-stored in package 10.
In other situations, however, it may be desired to utilize only a portion
of the fluid product stored in first section 18. In this situation, it may be
desired to incorporate a metering or valve device, generally 66, as part of
breakable seal 26. For example, referring to Figs. 3 and 4, seal 26 may
include a valve device 56 that permits introduction of product 12 into second
section 24 only so long as a compressive force is applied to first section 18.
In the embodiment illustrated, valve 56 comprises a conventional flap valve
having a rigid resilient flap 59 that seats against a surface 61. In an "at-
rest"
or static environment, fluid product 12 does not exert enough pressure
against flap 59 to open the valve. However, as illustrated in Fig. 4, upon
compression of section 18, hydraulic forces push flap 59 away from seat 61
allowing introduction of product 12 into second section 24. It should be
appreciated that any manner of resealable valve devices can be utilized in
this regard and that the flap valve illustrated in Figs. 3 and 4 is but an
example of any number of suitable devices.
It may also be desired to incorporate graduation or metering marks on
the surface of one of the sheets 30, 32, defining first compartment 20 of
first
section 18 so that the operator can accurately determine the amount of
CA 02326195 2000-09-27
WO 99/51509 PCT/U899/06871
product 12 introduced through valve 56 into second section 24. Such marks
118 are illustrated in the embodiments of Figs. 6 and 7.
It may also be desired to have the capability of introducing an external
substance or agent into one of the compartments of package 10. In this
5 situation, it may be preferred to incorporate a sealable access into one of
the
compartments, for example first compartment 20, for introducing the
additional element or product. Fig. 6 illustrates a package 100 according to
the invention wherein a first compartment access port 68 is provided. In the
embodiment illustrated, port 68 is a conventional syringe port wherein a
10' syringe 69 can be used to introduce an additional substance or agent into
the
first compartment of package 10. It should be understood that access port 68
can be provided in any of the embodiments of the invention illustrated and
described herein, and that any manner of conventional ports can be utilized in
this regard.
Additional preferred embodiments of the invention are illustrated
generally in Figs. 6 and 7. These embodiments are particularly useful
wherein it is desired to separately store at least two different fluid
products in
package 100, wherein the products can be subsequently mixed within
package 100 and dispensed from the package. Many of the components and
elements illustrated in Figs. 6 and 7 are identical to those illustrated and
described with regards to Figs. 1 through 5 and like reference numerals are
used in this regard. In general, package 100 utilizes a first section 102
defining at least a first compartment 104 having a first fluid product 108
stored therein. Package 100 includes a second section 106 defining a
compartment with a second fluid product 110 stored therein. A breakable
seal 26 separates the two compartments. The seal 26 can be provided as
described above.
Package 100 also includes a sealed port 112 through which the mixed
products are dispensed from the package. Preferably, port 112 is a
resealable device and, for example, includes a dispensing nozzle member
115 with a sealable cap 113. Any manner or construction of sealable devices
can be utilized in this regard.
CA 02326195 2000-09-27
WO 99/51509 PGT/US99/06871
11
In the embodiment of Fig. 7, breakable seal 26 incorporates the
metering valve or device 66, illustrated as flap valve 56. In this embodiment,
measured amounts of product 108 can be introduced into second section 106
and mixed with fluid product 110. In this regard, graduation marks 118 can
be provided on the sheets of material defining first section 102 so that the
operator can accurately measure the amount of product being introduced into
the second section. Likewise, graduation marks 118 can be provided on
second section 106 so that the operator can accurately measure the amount
of mixed products being dispersed from package 100.
It should be appreciated by those skilled in the art that various
modifications and variations can be made in the package according to the
present invention without departing from the scope or spirit of the invention.
For example, the package is not limited to any particular type of product
stored therein. In certain applications, an absorbent product may be desired,
and in other applications, fluid or liquid types of products may be stored and
mixed within the package. It is intended that the present invention include
such modifications and variations as come within the scope and spirit of their
appended claims and their equivalents.