U.S. patent application number 10/274002 was filed with the patent office on 2003-05-01 for applicator with protective barrier.
This patent application is currently assigned to Closure Medical Corporation. Invention is credited to Brady, Michael F., D'Alessio, Keith R., Rivera, Andres.
Application Number | 20030080151 10/274002 |
Document ID | / |
Family ID | 27359639 |
Filed Date | 2003-05-01 |
United States Patent
Application |
20030080151 |
Kind Code |
A1 |
D'Alessio, Keith R. ; et
al. |
May 1, 2003 |
Applicator with protective barrier
Abstract
An applicator for dispensing compositions includes a crushable
ampoule covered with a barrier material that serves as a protective
barrier. The applicator can also include a body made of a flexible
material that holds at least one crushable ampoule. The protective
barrier protects the user's fingers from puncture by shards created
during breakage of the crushable ampoule.
Inventors: |
D'Alessio, Keith R.; (Cary,
NC) ; Rivera, Andres; (Wake Forest, NC) ;
Brady, Michael F.; (Cary, NC) |
Correspondence
Address: |
OLIFF & BERRIDGE, PLC
P.O. BOX 19928
ALEXANDRIA
VA
22320
US
|
Assignee: |
Closure Medical Corporation
5250 Greens Dairy Road Raleigh, N.C. 27616
Raleigh
NC
27616
|
Family ID: |
27359639 |
Appl. No.: |
10/274002 |
Filed: |
October 21, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10274002 |
Oct 21, 2002 |
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10012441 |
Dec 12, 2001 |
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6478191 |
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10012441 |
Dec 12, 2001 |
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09447045 |
Nov 23, 1999 |
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6340097 |
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09447045 |
Nov 23, 1999 |
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09176889 |
Oct 22, 1998 |
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Current U.S.
Class: |
222/129 ;
215/12.2 |
Current CPC
Class: |
B05C 17/002 20130101;
A61M 35/003 20130101 |
Class at
Publication: |
222/129 ;
215/12.2 |
International
Class: |
B65D 023/00 |
Claims
What is claimed is:
1. An applicator comprising: at least one crushable ampoule having
an interior surface, an exterior surface, and a central portion,
the crushable ampoule being crushable upon application of a force
applied by a user's fingers, a flexible applicator body having a
hollow lumen, said at least one crushable ampoule being located
entirely within said hollow lumen of said applicator body, and a
polymeric barrier film disposed between an interior surface of said
flexible applicator body and said at least one crushable ampoule to
cover at least the central portion of the at least one crushable
ampoule where the predetermined force is applied and provide a
physical barrier to penetration by shards created by crushing of
the ampoule.
2. The applicator of claim 1, wherein said polymeric film is
polyester.
3. The applicator of claim 1, wherein said polymeric film is
transparent.
4. The applicator of claim 1, wherein the polymeric film is a tape
or label.
5. The applicator of claim 1, wherein the polymeric film is sized
to extend slightly larger than the at least one ampoule.
6. A method of making an applicator, comprising: providing at least
one crushable ampoule having an exterior surface and an interior
surface, the crushable ampoule being crushable upon application of
a force applied by a user's fingers, providing a flexible
applicator body having an open end, a closed end, and a hollow
lumen of a predetermined diameter, inserting a rolled polymeric
barrier film into said hollow lumen of said flexible applicator
body and allowing the barrier film to spring outward against an
interior surface of the applicator body, and inserting the at least
one crushable ampoule into said hollow lumen so that said polymeric
film is provided between the at least one crushable ampoule and the
interior surface of said flexible applicator body and covers at
least a central portion of the ampoule to protect against
penetration of shards created during crushing of said at least one
crushable ampoule.
7. The method of claim 6, wherein said polymeric barrier film is a
polyester film.
8. The method of claim 6, wherein said polymeric barrier film is
transparent.
9. The method of claim 6, wherein said polymeric barrier film
includes labeling indicia.
10. The method of claim 6, wherein said polymeric barrier film
comprises a tape.
11. The method of claim 6, wherein said polymeric barrier film is
in sheet form and initially rolled to a diameter smaller than the
predetermined diameter of the hollow lumen.
12. An applicator comprising: at least one crushable ampoule having
an interior surface, an exterior surface, and a central portion, a
flexible applicator body having a hollow lumen, with said at least
one crushable ampoule being located entirely within said hollow
lumen of said applicator body, and a clear polymeric barrier
material disposed within said hollow lumen between the at least one
crushable ampoule and an interior surface of said hollow lumen to
cover at least the central portion of the ampoule where a force is
applied by a user's fingers to break or crush the ampoule to
protect the user's fingers from glass shards created during the
break.
13. The applicator according to claim 12, wherein said polymeric
barrier material is a polyester film.
14. The applicator according to claim 12, wherein said polymeric
barrier material forms a label.
15. The applicator according to claim 14, wherein the label
includes indicia.
Description
[0001] This application is a Continuation-In-Part of co-pending
U.S. application Ser. No. 10/012,441 filed Dec. 12, 2001, which is
a Division of U.S. application Ser. No. 09/447,045 filed Nov. 23,
1999, now U.S. Pat. No. 6,340,097, which is a Continuation-In-Part
of U.S. application Ser. No. 09/176,889 filed Oct. 22, 1998, now
abandoned, the entire contents of which are hereby incorporated by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to applicators or dispensers which
comprise crushable ampoules, preferably housed within flexible
tubular containers. The invention also relates to methods of
producing such applicators or dispensers.
[0004] 2. Description of Related Art
[0005] Applicators comprising crushable glass ampoules housed
within flexible applicator bodies are known in the art. Examples of
such applicators comprise flexible tubular elements that have at
least one end permanently closed. The other end can be frangibly
closed or remain open to the environment. The crushable glass
ampoules are typically sealed and contain a composition to be
dispensed. Applicator tips are sometimes fixed to the open end to
aid in the application of the composition contained within the
ampoule. This type of applicator is useful for multiple
applications including use as air fresheners, use in dye marking,
and use in pregnancy test kits, as well as for dispensing medical
solutions, dental products, health and beauty aids, adhesives, and
other compositions. To use the dispenser, the flexible applicator
tube is squeezed at the area where the glass ampoule is located.
Sufficient force is applied by a user's fingers to break the glass
ampoule, releasing the composition contained within. The
composition is then applied through, or otherwise allowed to exit,
the open end (i.e., the end with the applicator tip).
[0006] One drawback to such applicators is the possibility of a
glass shard from the broken ampoule piercing the flexible tube and
entering the user's hand during crushing and dispensing. Upon
crushing of the glass ampoule, multiple small sharp glass shards
are created. Among the glass shards created during breakage of the
glass, shards having a length sufficient to transect the flexible
applicator tube are created. A certain percentage of these shards
become reoriented such that they are perpendicular to the length of
the applicator tube (i.e., with their longitudinal axis oriented
toward the user's finger(s)). The force applied during crushing and
dispensing can be sufficient to force at least some of these
reoriented shards through the flexible tube and into the user's
finger(s).
[0007] This disadvantage is overcome in some applicators by a
cardboard overcap that can be placed around the applicator body to
protect the user's fingers during crushing of the ampoule. Such an
applicator, consisting of a glass ampoule, a plastic butyrate tube,
and a cardboard overcap, is sold by the James Alexander Corporation
of Blairstown, N.J. In operation, prior to crushing of the ampoule,
the cardboard sleeve is slid over the ampoule and the user crushes
the ampoule by squeezing the ampoule with the user's fingers
through the cardboard sleeve. However, this solution does not
eliminate the production of reoriented glass shards, and is subject
to a certain failure rate due to the reoriented shards puncturing
the overcap along with the flexible tube. It also requires a
separate part that makes the dispenser a two-handed operation to
place the cardboard cover on the applicator. Moreover, as the
sleeve is opaque, one cannot see whether the ampoule has been
properly crushed during use without removal of the sleeve.
[0008] Commonly assigned U.S. Pat. No. 5,928,611 (previously
published under PCT Application No. WO 96/40797), the disclosure of
which is hereby incorporated in its entirety, discloses an
applicator for dispensing polymerizable or cross-linkable monomer
compositions. The applicator comprises an applicator body that
holds a crushable ampoule. The crushable ampoule contains the
monomer composition that is to be dispensed. The applicator can
further comprise an applicator tip. This applicator, like those
described above, does not disclose means to avoid reorientation of
glass shards.
[0009] Other methods for protecting a user's hands during crushing
of a glass ampoule are disclosed in U.S. Pat. No. 5,690,958 to
McGrath. McGrath discloses a unit dose applicator for dispensing
chlorhexadine gluconate (CHG). The applicator may be an elongated
cylindrical glass vial or ampoule that is housed within an
elongated cylindrical, flexible, synthetic resin cover of a size to
fully encase the vial. A porous applicator swab is fitted within
one end of the applicator cover, and extends outward therefrom. The
cover is disclosed as being a protective cover that protects the
user's hand from glass shards created during crushing of the unit
dose glass container. However, McGrath does not disclose or claim
the use of his applicator to dispense anything except CHG and has
the disadvantage that reoriented glass shards can puncture the
protective resin cover.
[0010] U.S. Pat. No. 4,826,025 to Abiko et al. discloses an ampoule
package that is designed to be precisely cut at a constriction
between upper and lower sections of the package. A heat-shrink film
is provided over the constriction part to prevent scatter of fine
particles of glass formed by the cutting of the constriction. Such
an ampoule is not designed to be crushed by a user's fingers. Thus
Abiko is not concerned with problems of reoriented glass shards
that could puncture a user's fingers during the crushing.
[0011] Similarly, it is known to coat glass bottles with coating
materials to improve resistance to breaking. For example, U.S. Pat.
Nos. 3,877,969, 3,889,013, and 4,099,638 to Tatsumi et al. disclose
coating the surface of glass bottles with two different kinds of
coating materials in a specific sequence. The coating materials
include an olefin copolymer containing OH and/or COOH groups in its
molecule. The coating also includes a polyisocyanate or a mixture
of a polyisocyanate and a polyol or a thermoplastic polyurethane.
These methods are not disclosed as having applicability to, and in
fact are conceptually opposed to, glass containers that are
designed to be broken, such as glass ampoules broken by finger
pressure. Rather, they are intended to resist or prevent
breakage.
SUMMARY OF THE INVENTION
[0012] Thus, there is a need for an applicator comprising a
crushable ampoule that can be used without fear of puncture of the
skin during crushing. The present invention satisfies that need by
providing a protective barrier material over the surface of the
crushable ampoule. The protective barrier material not only
protects a user's hand from puncture with shards created during
crushing of the ampoule, but it can be used and incorporated in an
applicator in a convenient and economical manner.
[0013] The invention provides an applicator or dispenser, which
comprises a crushable ampoule, containing a composition to be
dispensed, that is covered or coated by a resistant barrier
material. The applicator can further comprise a hollow applicator
body made of a flexible and deformable material. The applicator
body is of a generally tubular shape, having an end that is
permanently closed and another end that can either be closed
(sealed) or open to the environment. At least one crushable ampoule
is contained within the lumen of the applicator body. Each
crushable ampoule is sealed and can contain a composition that is
to be delivered or applied to a site or reacted with another
material in the applicator. Disposed over a surface of each
crushable ampoule is a material or layer that acts as a barrier
against formation of reoriented glass shards upon crushing of the
ampoule. The barrier material can be applied to either or both of
the interior or exterior surface of the crushable ampoule, applied
between the ampoule and applicator body, and/or applied to the
exterior of the applicator body. It may be applied to the entire
interior and/or exterior surface of the applicator body or ampoule,
or may be applied only to a selected portion of such surface. In
the latter case, it is preferably applied to a portion, such as a
central portion, that is most susceptible to crushing and shard
reorientation.
[0014] According to one aspect of the invention, the barrier
material protects a container body, and thus a user's fingers, from
puncture by reoriented glass shards during crushing of the ampoule
by the barrier material being in contact with both the flexible
tube of the applicator body and the crushable ampoule. The contact
may be through affixing of the barrier material to at least one of
the ampoule and the applicator body or by adhesive contact.
[0015] According to another aspect of the invention, the barrier
material is in contact with an interior surface of the ampoule.
Again, the contact may be through affixing or adhering of the
barrier material to the ampoule.
[0016] According to a further aspect of the invention, the barrier
material may be a resistant polymeric layer, such as a MYLAR.RTM.
polyester film, affixed to the exterior of the ampoule, such as
between the ampoule and applicator body, or affixed to the exterior
of the applicator body.
[0017] According to yet another aspect of the invention, the
barrier material may be the combination of an adhesive layer and a
label adhered to an exterior surface of the applicator body.
[0018] According to yet a further aspect of the invention, the
barrier material may be a plastic composition coated on the
exterior of the ampoule or applicator body.
[0019] According to each of the above-described aspects, the
barrier material is thin enough and/or flexible enough to allow
crushing of the ampoule by an average person's finger pressure.
[0020] The invention also provides a method of making an applicator
or dispenser. The method comprises applying a barrier material to a
surface of one of the crushable ampoule and the applicator body.
The method can further comprise inserting the coated crushable
ampoule into the applicator body.
[0021] Alternatively, the method may include insertion of the
barrier material onto an interior surface of the applicator body
before insertion of the ampoule within a lumen of the applicator
body. Upon insertion of the ampoule, the barrier material is spread
over a substantial surface of the ampoule to provide resistance to
reorientation and/or puncture by glass shards.
[0022] The method may also include application of a barrier
material to the exterior surface of the ampoule before insertion of
the ampoule within the lumen of the container body.
[0023] The method may also include insertion of the barrier
material onto an interior surface of the applicator body before
insertion of the ampoule within a lumen of the applicator body.
Upon insertion of the barrier material into the applicator body,
the barrier layer, preferably a plastic film, will "spring" outward
to tightly contact the inner walls of the applicator body. Then,
upon insertion of the ampoule, the barrier becomes constrained
between the ampoule and the applicator body to provide a protective
barrier layer that protects a user from glass shards penetrating
the applicator body.
[0024] The barrier material may be an adhesive that is coextruded
with the flexible material making up the applicator body.
[0025] When the barrier material is adhered to or in close
proximity of a surface of the crushable ampoule, the number of
reoriented shards generated during crushing of the ampoule can be
reduced or eliminated. Thus few, if any, reoriented shards that can
transect the applicator and puncture the user's skin are created.
This is because the shards, when created, are trapped by the
barrier material in the orientation in which they were created. In
this manner, puncturing of the user's fingers by reoriented shards
is reduced or eliminated, and the safety of the applicator is
improved. Furthermore, because a wide variety of barrier materials
can be used, which are generally inexpensive, the barrier material
can be incorporated without a significant increase in the cost of
producing the applicator. In addition, the applicator can be used
in a single, one-handed operation, and does not inhibit the view of
the applicator. Moreover, when the barrier material is affixed or
adhered in place, there is no possibility that the sleeve may slide
from a desired area to be protected.
[0026] Thus, in some embodiments, the barrier material may form a
layer or coating that is affixed to or adheres tightly to the
material from which the ampoule is made. During crushing of the
ampoule, the barrier material in these embodiments continue to be
affixed to or adhered to the material of the ampoule, and, to a
great extent, to itself. Thus, the three dimensional structure of
the barrier material is not completely destroyed during the
crushing process. In other words, although the ampoule is crushed,
the general shape of the ampoule is retained by the barrier
material on the ampoule. Because the barrier material remains
affixed or adhered to the shards of the ampoule and generally
retains its original shape, the production of reoriented shards is
greatly reduced. Furthermore, at least one area of the ampoule is
preferably left uncovered so that the composition within the
ampoule can escape upon crushing of the ampoule. The uncovered area
can be provided as one relatively large area, for example at one
end of the ampoule, or can be provided as many relatively small
areas dispersed over a specific area or over the entire ampoule.
The uncovered area can be any shape or size as long as the
protective function of the barrier material is not compromised.
[0027] It is often preferable for the barrier material to have
adhesive properties so that it can be directly adhered to the
material comprising the ampoule. If the barrier material is not
adhered to (or sufficiently affixed to) this ampoule material,
then, upon crushing of the ampoule, reorientation of shards can
occur because they are not trapped in their original orientation.
In embodiments where the barrier material is an adhesive, the
adhesive material itself does not provide a sufficient physical
barrier to the shards, as it is easily punctured by reoriented
shards. It is the substantial blocking of reorientation of the
shards by the adhesive in these embodiments that provides the
protective function of the present invention.
[0028] In other aspects of the invention, the barrier material may
be affixed to the ampoule and serve to partially prevent
reorientation and may also be formed of a material that provides a
physical barrier to penetration by shards of glass.
[0029] Further, when the barrier material is provided adjacent the
exterior surface of the ampoule, entrapment of the shards by the
barrier material provides an added level of protection by providing
a barrier against shards that failed to be adhered by the barrier
material. For example, during crushing, a certain, although small,
portion of the shards will not be adhered to by the adhesive
barrier material. This is especially true for shards that are
created solely from ampoule material at surfaces not covered by the
adhesive barrier material. A certain percentage of these free
shards can become reoriented. However, the shards entrapped by the
adhesive form a relatively thick, strong layer that can stop the
reoriented shards from passing through and into the user's fingers.
Thus, the shards themselves provide added protection and serve as a
protective physical barrier in such embodiment, allowing the use of
an adhesive with weak physical barrier properties.
[0030] The applicator body can hold one crushable ampoule
containing a composition to be dispensed and/or reacted, or can
contain multiple crushable ampoules, each containing a composition
to be dispensed and/or reacted. When the applicator comprises
multiple ampoules, each ampoule can hold either the same
composition or a different composition. Included is the situation
where multiple ampoules contain the same composition while other
ampoules contain different composition(s). For example, the
applicator can comprise two crushable ampoules. The first ampoule
holds the first part of a two-part adhesive and the second ampoule
holds the second part of a two-part adhesive, such as a two-part
epoxy adhesive. Furthermore, in embodiments where multiple ampoules
are included, at least one ampoule can be contained within
another.
[0031] Although the invention is further described with respect to
preferred applicators comprising an applicator body that contains a
coated crushable glass ampoule, the invention also encompasses
applicators comprising the adhesive-coated ampoule alone.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] FIG. 1 depicts an applicator of the present invention.
[0033] FIG. 2 is an exploded view of one embodiment of the
applicator of FIG. 1, depicting the barrier material disposed on
the exterior surface of the crushable ampoule.
[0034] FIG. 3 is an exploded view of one embodiment of the
applicator of FIG. 1, depicting the barrier material disposed on
the exterior surface of the crushable ampoule as part of a
label.
[0035] FIG. 4 is an exploded view of one embodiment of the
applicator of FIG. 1, depicting the barrier material disposed on
the interior surface of the applicator tube.
[0036] FIG. 5 depicts a preferred embodiment of the present
invention.
[0037] FIGS. 6a-6c depict a method of making an applicator
according to one embodiment of the present invention.
[0038] FIG. 7 is a view of one embodiment of the invention in which
the barrier material is a polymeric film affixed to the exterior of
the applicator tube.
[0039] FIGS. 8a-c depict a method of making an applicator according
to another embodiment of the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0040] With reference to FIG. 1, the present invention provides an
applicator 1 comprising an applicator body 2, which is formed
generally in the shape of a tube having a closed end 3, an open end
4, and a hollow interior lumen 12, which holds a crushable or
frangible ampoule 5. The ampoule contains a composition 6, which is
to be dispensed from the applicator. According to one aspect of the
invention, a barrier material 7 is disposed between the interior
surface of the applicator body and the exterior surface of the
crushable ampoule. Although the present invention is extremely
useful in conjunction with ampoules made of glass, ampoules made of
other brittle materials can create reoriented shards and are
encompassed by the present invention. Further, although FIG. 1
depicts a preferred embodiment wherein the ampoule has an outer
diameter that is fractionally smaller than the inner diameter of
the applicator body, such a relationship is not a critical feature
of the invention. Thus, an applicator having a crushable ampoule
that has a significantly smaller outer diameter than the inner
diameter of the applicator tube is encompassed by the present
invention. Furthermore, the ampoule need not be in the shape of a
tube, but can be in any chosen shape, including oval, round,
etc.
[0041] Alternately, the barrier material can be disposed on the
interior surface of the crushable ampoule. Layering or coating the
barrier material on the interior surface of the crushable ampoule
provides the same benefits as coating the exterior surface of the
crushable ampoule. However, coating the interior surface is not as
convenient and economical, and is thus an embodiment of the
invention that is not as highly preferred in many cases.
[0042] As depicted in FIG. 2, the barrier material 7 is disposed on
the exterior surface of the crushable ampoule 5. The barrier
material is applied to the ampoule prior to inserting the ampoule
into the hollow interior area 12 of the applicator body 2. The
barrier material 7 may be an adhesive. In such an embodiment,
sufficient adhesive is applied to the surface to coat the surface
at least over the central portion 8 of the ampoule. As used herein,
the central portion of the ampoule is that portion of the ampoule
that is covered by the user's fingers when the applicator is in
use. Thus, the central portion of the ampoule includes that portion
of the ampoule where crushing force is applied, as well as that
portion of the ampoule where force is applied during dispensing of
the composition 6. The amount of adhesive barrier material applied
to the ampoule is preferably sufficient to completely cover the
central portion, although small gaps in coverage may be permitted.
This permits the adhesive to adhere to the entire surface of the
ampoule to which force is applied so that reorientation of shards
is minimized at these areas. Although the adhesive barrier material
need not be applied to those portions of the ampoule that are not
likely to be crushed, or that are not likely to be between the
user's fingers during operation, it is preferred that these areas
be covered as well.
[0043] In embodiments, the adhesive barrier material is applied to
the exterior surface of the ampoule and allowed to cure (or set)
prior to inserting the ampoule into the applicator body. As used
herein, the terms "cured" adhesives are those encompassed by
pressure-sensitive adhesives that are in a state ready for use,
hot-melt adhesives that are in the solid state, and reactive
adhesives that have undergone the reaction required to generate the
desired properties of the adhesive (for example, polymerizable
adhesive materials that have polymerized).
[0044] In other embodiments, the adhesive barrier material is
applied and the ampoule is inserted into the applicator body before
the adhesive cures. The adhesive is then allowed to cure while the
ampoule is within the applicator body. In embodiments where an
ampoule is used that has an outer diameter that is fractionally
smaller than the inner diameter of the applicator tube, the
adhesive can adhere to both the exterior surface of the ampoule and
the interior surface of the applicator tube upon curing. Such dual
adhesion aids in anchoring of the ampoule at a specific point
within the applicator and can be desirable when the length of the
ampoule is significantly shorter than the length of the applicator
body.
[0045] Alternatively, the barrier material 7 can be of a polymeric
substance, such as a MYLAR.RTM. polyester film or a plastic
coating, that is affixed to the ampoule by a friction fit,
mechanical bond, as part of a coating or dipping process or by
other common methods of affixing or coating. By affixing or
adhering the barrier material to the ampoule, the amount of
reoriented shards can be reduced. Also in this embodiment, the film
coating thickness can be selected to remain flexible, while
providing an improvement in physical barrier properties over the
adhesive embodiment.
[0046] In an embodiment depicted in FIG. 3, the adhesive barrier
material 7 that is applied to the exterior surface of the ampoule
is an adhesive that is also used to adhere an adhesive tape or
label 9 to the ampoule. In this embodiment, the adhesive serves the
purpose of holding the shards in their original orientation upon
crushing of the ampoule as well as permitting the tape, a label, or
the like to be affixed to the ampoule. For example, the label can
be any of the known adhesive-backed labels commonly used in the
medical, industrial, and business industries, such as polyester
labels and the like. The label can be used to indicate the identity
of the composition within the ampoule, the date it was filled, the
expiration date, or any other relevant information.
[0047] In an embodiment depicted in FIG. 4, the interior surface of
the applicator body 2 is coated with a barrier material 7, which
may be an adhesive or a polymeric layer as described above, affixed
to the applicator body. In this embodiment, when an adhesive is
used, the crushable glass ampoule may be inserted before the
adhesive cures. The adhesive adheres to the interior surface of the
applicator body and the exterior surface of at least the central
portion 8 of the crushable ampoule and provides a protective
barrier. In this embodiment, the uncured adhesive contacts and
preferably completely covers at least the central portion 8 of the
ampoule and is allowed to cure while covering this area.
[0048] In preferred embodiments of the invention, the applicator
can comprise elements other than the applicator body and ampoule.
As shown in FIG. 5, for example, an applicator tip 10 is provided
on the applicator 1. The applicator tip can have a variety of
suitable shapes, including, but not limited to, conical,
cylindrical, chisel or polygonal shapes. The length and size of the
tip can be varied depending on various application parameters. The
tip may be detachable from the applicator body, or may be an
integral part of the applicator. The tip further may be in the form
of a nozzle for atomizing liquid solutions. The tip can be composed
of any of a variety of materials including polymerized materials
such as plastics, foams, rubber, thermosets, films, or membranes.
Additionally, the applicator tip may be composed of materials such
as metal, glass, paper, ceramics, cardboard, and the like. The
applicator tip material may be porous, absorbent, or adsorbent in
nature to enhance and facilitate application of the composition
within the ampoule. In general, the only limitation on the
materials used to fabricate the tip is that the tip must be
sufficiently compatible with the composition to be dispensed that
undesirable effects on the composition do not prevail during
contact of the composition with the tip.
[0049] Further, as shown in FIG. 5, the applicator can comprise a
screen or filter 11 between the crushable ampoule and the open end
4 of the applicator body 2. Although it should not be necessary in
the applicator of the present invention, it can be incorporated to
stop any shards that are released upon breaking of the ampoule from
exiting the applicator along with the composition being
applied.
[0050] As depicted in FIGS. 6a-6c, both the interior surface of the
applicator body and the exterior surface of the crushable ampoule
can be coated with the material at the same time. As shown in FIG.
6a, uncured adhesive barrier material 7 is placed within the closed
end 3 of the applicator body 2. As shown in FIG. 6b, the crushable
ampoule 5, which has an outer diameter that is fractionally smaller
than the inner diameter of the applicator body, is then inserted
through the open end 4 into the applicator body 2. In this manner,
when the ampoule is inserted into the hollow inner area 12 of the
body 2, and forced to the bottom of the tube, the adhesive within
the tube is displaced and forced into the space between the ampoule
and the body (FIG. 6c). In this embodiment, enough adhesive is
originally placed within the applicator body so that displacement
of the adhesive results in coverage of at least the central portion
of the ampoule. The adhesive is then permitted to cure and adhere
to both surfaces.
[0051] In an embodiment depicted in FIG. 7, a barrier material 7 is
affixed to an exterior surface of the applicator body 2. The
barrier material 7 preferably covers at least the central portion 8
of ampoule 6 to protect a user's fingers from shards during use of
the applicator (forced breakage of the ampoule 6). A suitable
barrier material 7 is a polymeric layer, such as a MYLAR.RTM.
polyester film, which is preferably clear to allow viewing of the
contents of ampoule 6, while still providing a protective barrier
that is affixed to the applicator to cover the critical central
area of the ampoule 6 where breakage of ampoule 6 is to be induced
by a user's fingers applying a suitable pressure. As in the FIG. 5
embodiment, the applicator 1 may be provided with a suitable
applicator tip 10 on open end 4 opposite closed end 3. The barrier
material 7 may include indicia or other markings such that the
protective barrier material can also serve as an applicator label.
The barrier material 7 can have a wide latitude of sizes and
thicknesses so long as at least open end 4 is left uncovered to
allow exiting of the contents of ampoule 6 and the barrier material
7 is sufficiently flexible or compressible to allow breakage of
ampoule 6 by application of finger pressure or its equivalent
acting through the barrier material 7 to be transmitted to the
ampoule 6 within.
[0052] The material that comprises the flexible applicator body is
any material that is flexible, and allows forces generated on the
outside of the body to be transmitted to the ampoule within. The
material can be any material that is sufficiently compatible with
the barrier material and/or composition to be applied such that
undesirable effects on the composition to be dispensed are not seen
as a result of contact between the applicator body material and the
composition. In preferred embodiments, the flexible material is
transparent or translucent, allowing the user to see inside the
tube and view the location and contents of the ampoule. In
embodiments, the body is made of a plastics material. Such
materials are easily selected by those of ordinary skill in the
art, and include, in preferred embodiments, cellulose acetate
butyrate, polypropylene, polyethylene, polyethylene terephthalate,
and other flexible plastics. Co-extruded layers of different
materials can provide desirable combinations of properties
depending on the ultimate use and manufacturing process of the
applicator. Exemplary materials are commercially available, e.g.,
as triple-layer co-extruded tubes such as those produced by
Medi-Flex Hospital Products, Inc. (Overland Park, Kans.).
[0053] In an embodiment depicted by FIGS. 8A-C, the barrier
material 7 can be of a polymeric substance, such as the MYLAR.RTM.
polyester film or plastic coating of previous embodiments, that is
provided between the ampoule and applicator body. Preferably, the
barrier material 7 is transparent. As in prior embodiments, barrier
material 7 may form a label.
[0054] In FIG. 8A, barrier material 7 is in sheet or film form and
is rolled up to fit within open end 4 of applicator body 2 as shown
so as to be provided within hollow interior lumen 12. Upon
insertion, barrier material 7 "springs" outward by internal forces
so as to fit tightly against inner walls of applicator body 2 as
shown in FIG. 8B. Barrier material 7 may be sized to substantially
fit the interior with little or no overlap as shown or may be
oversized to retain some overlap in material. Then, frangible
ampoule 5 containing composition 6 is inserted into the applicator
body lumen 12. The resultant applicator shown in FIG. 8C results in
barrier material 7 being provided between ampoule 5 and applicator
body 2 to provide a physical barrier to shard penetration during
use. Preferably, the barrier material 7 covers at least the central
portion of ampoule 5. The film thickness of barrier material 7 is
selected so as to remain flexible, while providing an improvement
in physical barrier properties so as to resist shard penetration
through applicator body 2.
[0055] The material that comprises the ampoule is any material that
is crushable or frangible, and that can be used to contain solid,
liquid, or gaseous materials. In preferred embodiments, the
crushable or frangible ampoule is made of glass or frangible
plastics. Any suitable type of glass can be used to fabricate the
ampoule, including, but not limited to, borosilicate glass and soda
lime glass.
[0056] Compositions that can be contained within the ampoule and
dispensed with the applicator are not particularly limited. Any
material that a user desires to hold and dispense with the present
applicator can be used, as long as the material is compatible with
the materials used to fabricate the ampoule and the applicator body
(and any other components of the applicator, such as the applicator
tip, if present). Materials that can be held within the ampoule and
dispensed with the applicator include gases, liquids, and
solids.
[0057] Examples of gases include, but are not limited to, those of
medical and industrial importance for verifying testing equipment,
as well as initiators for chemical reactions, and gases that effect
a biological response. Included in these types of gases are air,
carbon monoxide (CO), methane (CH.sub.4), hydrogen sulfide
(H.sub.2S), oxygen (O.sub.2), and carbon dioxide (CO.sub.2), as
well as activators, reactants, stabilizers, and fragrances.
[0058] Examples of liquids include, but are not limited to, those
applicable to medical, industrial, and home use. Included among
these liquids are drugs, antiseptics, cleansers, solvents, dental
products, adhesives, fragrances, and lubricants. Especially useful
liquids include polymerizable liquid adhesives, such as the
cyanoacrylate adhesives described in U.S. Pat. No. 5,928,611 and
copending U.S. patent application Ser. No. 09/099,457, the
disclosures of which are hereby incorporated by reference in their
entireties.
[0059] Examples of solids include, but are not limited to, those
that are dissolvable or dispersable in, or reactive with, liquids
and gases, and those with medical, industrial, or home
applications. Included among these types of solids are smelling
salts, drugs, adhesives, cosmetics and other beauty or hygiene
products.
[0060] The barrier material used as the protective coating can be
any barrier material that is compatible with the materials
comprising the applicator body and the ampoule and capable of
adhering to or being affixed to the material of the ampoule and/or
applicator body. To achieve such adherence or affixing, the ampoule
may or may not be pretreated. When the barrier material is an
adhesive, it can be applied as a pre-adhesive material (i.e.,
uncured) or as a cured adhesive. Examples of uncured adhesive
materials include those materials that do not show strong adhesive
properties, but can be converted into adhesives through chemical
reactions, irradiation, or other types of interactions. For
example, materials that polymerize upon irradiation or exposure to
acids or bases can be used. Cured adhesives include adhesives that
do not require further chemical reactions to impart an adhesive
characteristic. Examples of cured adhesives include pressure
sensitive adhesives such as those commonly applied to tapes or
labels. Regardless of the state of the adhesive barrier material
when it is applied, when used in the applicator of the invention,
it should be cured at least to the point that it possesses the
desired adhesive properties.
[0061] Adhesives useful in the invention include, but are not
limited to, liquid adhesives. Exemplary suitable adhesives
materials for use as the coating material include, but are not
limited to, silicone room temperature vulcanization adhesives
(RTVs), UV curable adhesives, hot melt adhesives, two-part
adhesives (including epoxies), pressure sensitive adhesives,
polymerizable adhesives (including cyanoacrylates), resins
(including aliphatic resins), polyurethane, polyvinyl acetate,
contact cements, and hide glues.
[0062] Included among the suitable adhesives are those adhesives
with relatively low melting points. Also included are those that
are liquid at room temperature (approximately 21-25.degree. C.).
For instance, the adhesive can be a liquid at an elevated
temperature, for example 80.degree. C., which cures at a lower
temperature, such as room temperature. The adhesive can be applied
to the exterior surface of the ampoule and allowed to cool to form
the protective barrier on the ampoule. Alternately, the heated
liquid adhesive can be applied to the interior surface of the
applicator body, the ampoule can be inserted, and the adhesive
allowed to cure by lowering the temperature. In such a situation,
upon cooling of the applicator, the adhesive cures and forms the
coating.
[0063] In embodiments, the interior surface of the applicator body
can be coated or layered with a low melting point adhesive. Upon
insertion of the ampoule into the applicator body, the applicator
is heated to melt the low melting point adhesive. The applicator is
then allowed to cool, allowing the adhesive to set up and form a
protective barrier.
[0064] Similarly, as-discussed above, the crushable ampoule can be
coated with a low melting point adhesive. In this embodiment, upon
insertion of the ampoule into the applicator body and heating of
the applicator, the adhesive melts. Once the applicator is allowed
to cool, the adhesive sets up and forms a protective barrier.
[0065] The applicator body 2 can also have a polymeric barrier
material layer 7, such as a MYLAR.RTM. polyester label or film,
affixed to or otherwise provided to cover portions of the interior
or exterior surface of the body 2 where fingers or the like will be
used to crush the ampoule and may be otherwise subjected to glass
shards from the crushed ampoule. The polymeric film is preferably
clear to allow viewing of the contents of the ampoule and may be
removable.
[0066] The barrier material 7 may also be a polymeric or plastic
barrier layer coated onto a surface of the ampoule 6 itself, such
as by dipping of the ampoule 6 into a non-cured liquid polymeric
material, which upon subsequent drying or curing becomes coated on
the surface of ampoule 6. Other known plastic coating techniques,
using liquid, powder or solid polymeric materials can be used to
apply the coating onto the ampoule surface.
[0067] The present invention also includes coextrusion of a
flexible tube with an adhesive or polymeric protective material,
wherein the adhesive or protective material is extruded such that
it is located on the interior portion of the tube. Upon insertion
of the crushable ampoule, the applicator can be heated, thus
melting a low melting point adhesive or protective material. Upon
cooling of the applicator, a protective coating is formed.
* * * * *