U.S. patent application number 09/731128 was filed with the patent office on 2002-06-06 for hermetically sealed container with medicament storing and dispensing insert.
Invention is credited to Leo, Frank N., Weiler, Gerhard H..
Application Number | 20020066748 09/731128 |
Document ID | / |
Family ID | 24938182 |
Filed Date | 2002-06-06 |
United States Patent
Application |
20020066748 |
Kind Code |
A1 |
Weiler, Gerhard H. ; et
al. |
June 6, 2002 |
HERMETICALLY SEALED CONTAINER WITH MEDICAMENT STORING AND
DISPENSING INSERT
Abstract
A hermetically sealed container and a medicament bearing insert
assembly therefor are disclosed. The medicament bearing insert
assembly is protected by a severable overcap. A pocket within the
insert assembly is provided with a pierceable membrane. Rupture of
the membrane by a built-in plunger causes the medicament to drop
out of the pocket and into the container where it is mixed with the
container contents.
Inventors: |
Weiler, Gerhard H.;
(Woodstock, IL) ; Leo, Frank N.; (Crystal Lake,
IL) |
Correspondence
Address: |
OLSON & HIERL, LTD.
36th Floor
20 North Wacker Drive
Chicago
IL
60606
US
|
Family ID: |
24938182 |
Appl. No.: |
09/731128 |
Filed: |
December 6, 2000 |
Current U.S.
Class: |
222/129 ;
206/219; 206/222; 215/DIG.8; 222/541.6 |
Current CPC
Class: |
A61J 1/2093 20130101;
B65D 1/0238 20130101; B65D 51/2828 20130101; A61J 7/0046 20130101;
A61J 1/067 20130101; A61J 1/2027 20150501 |
Class at
Publication: |
222/129 ;
206/222; 206/219; 215/DIG.008; 222/541.6 |
International
Class: |
B65D 025/08; B67D
005/56 |
Claims
We claim:
1. A hermetically sealed container which comprises: a container
body portion which terminates into a hollow neck portion that
defines a socket; a medicament bearing insert assembly sealingly
received in said socket and including a base member immobilized in
said socket and defining a medicament pocket with a proximal
aperture occluded by a rupturable membrane unitary with the base
member; a solid medicament in said pocket; and a plunger engaged by
said base member, movable in said pocket, and adapted to penetrate
said membrane so as to dispense the medicament into the container
through the proximal aperture in the base member but without fully
severing the membrane from the base member; and a severable overcap
unitary with the container and delineated from the neck portion by
a frangible web.
2. The container in accordance with claim 1 wherein the plunger is
provided with a tip for piercing and rupturing the membrane when
the plunger is urged against the membrane.
3. The container in accordance with claim 1 wherein the plunger is
slidably movable into said pocket to pierce the membrane.
4. The container in accordance with claim 1 wherein the plunger is
threadedly movable into said pocket to sever a portion of the
membrane about the periphery thereof.
5. The container in accordance with claim 4 wherein the overcap is
permanently secured to said plunger and said plunger is threadingly
movable into said pocket in response to the turning of said
overcap.
Description
FIELD OF THE INVENTION
[0001] This invention relates to a hermetically sealed container
which includes a body filled with a liquid and, more particularly,
to an insert for such a container adapted to store and thereafter
dispense a medicament such as a tablet into the liquid in the
container.
BACKGROUND OF THE INVENTION
[0002] Hermetically sealed containers can be readily produced by
the so-called blow/fill/seal techniques. Utilizing such techniques,
a container body is first blow molded from an extruded parison
segment, then charged (or filled) with a desired liquid, and
thereafter sealed with a preformed closure insert. See, for
example, the container structure disclosed in U.S. Pat. No.
4,596,110 to Weiler.
[0003] The liquid in the container body is typically dispensed
through the insert and then mixed with another liquid or solid
deposit prior to being ingested or otherwise used. A disadvantage
associated with the mixing of a deposit or the like into the liquid
dispensed from the container prior to ingestion or use is the
increased risk of contamination inherent in the handling,
manipulation and mixing of the deposit such as a tablet or the like
in a non-sterile environment.
[0004] There is thus presently a need for a hermetically sealed
container where the liquid or solid deposit intended to be mixed
with the liquid in the container is stored in the container and
mixed with the liquid in the container prior to being dispensed
from the container to eliminate the risk of contamination and to
simplify the mixing and dispensing procedure.
SUMMARY OF THE INVENTION
[0005] A hermetically sealed container of the present invention
incorporates a preformed medicament bearing insert assembly adapted
and structured to store and thereafter dispense a solid medicament,
such as a medicinal tablet or the like, into a liquid contained in
the body of the container.
[0006] More particularly, the insert assembly defines a base member
with sealed cavity having a rupturable unitary membrane therewith
and a solid medicament contained in the cavity. A plunger provided
in the insert assembly is adapted to penetrate the membrane so that
the medicament can drop into the body of the container when the
plunger is activated. The plunger can be axially slidable or
threaded, as desired. The membrane is not completely severed from
the base member, however, to dispense the medicament.
[0007] The medicament can be a tablet, a capsule, a pill, an
aliquot of a powder, and the like.
[0008] The insert assembly is encapsulated within a hermetically
sealed container molded of a thermoplastic material and having a
body portion, a neck portion, and an severable overcap unitary
therewith. The neck portion defines a socket for the insert
assembly. The severable overcap is delineated from the neck portion
by a peripheral frangible web, and protects the insert assembly
during storage and handling from premature activation. When the
overcap is removed or severed from the container by a twisting
action, the plunger, which is part of the insert assembly, can be
activated to release the medicament into the body of the container
by urging the plunger against the membrane so as to partially sever
the membrane from the insert assembly.
[0009] Other advantages and features of the present invention will
be more readily apparent from the following detailed description of
the preferred embodiment of the invention, the accompanying
drawings, and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] In the Drawings,
[0011] FIG. 1 is a perspective view of a hermetically sealed
container embodying the present invention;
[0012] FIG. 2 is an enlarged, partial front elevational view,
partially broken away and shows the insert received in a socket
provided in the neck portion of the container;
[0013] FIG. 3 is a cross-sectional view of the container socket and
insert;
[0014] FIG. 4 is a cross-sectional view of the container socket and
insert structure where the plunger of the insert assembly has
pierced the membrane thereof preparatory to medicament release;
[0015] FIG. 5 is a cross-sectional view of the container socket and
insert assembly depicting the plunger in a position where the
medicament is released from the insert assembly into the body of
the container;
[0016] FIG. 6 is an enlarged, partial front sectional view of an
alternate insert assembly embodying the present invention;
[0017] FIG. 7 is a view similar to FIG. 6 and showing a medicament
being dispensed;
[0018] FIG. 8 is an enlarged, front sectional view of an alternate
container embodying the present invention;
[0019] FIG. 9 is an enlarged partial front elevational view,
partially broken away, and showing the dispensing nozzle of the
container; and
[0020] FIG. 10 is a perspective view depicting the container of
FIG. 1 in its dispensing position with the overcap and dispensing
cap removed therefrom and the medicament in the liquid dissolved in
the contents of the container.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] The invention disclosed herein is, of course, susceptible of
embodiment in many different forms. Shown in the drawings and
described below in detail are preferred embodiments of the
container of the present invention. It is to be understood,
however, that the present disclosure is an exemplification of the
principles of the invention and does not limit the invention to the
illustrated embodiments.
[0022] For ease of description, the container of the present
invention will be described in a normal (upright) operating
position and terms such as upper, lower, horizontal, etc., will be
used with reference to this position. It will be understood,
however, that the container and the insert assembly of the present
invention may be manufactured, stored, transported, used, and sold
in an orientation other than the position described.
[0023] A formed, filled, and hermetically sealed thermoplastic
container 10 embodying the insert assembly structure of the present
invention is illustrated in FIG. 1. Container 10 is preferably
fabricated, using a method similar to the method disclosed in U.S.
Pat. No. 4,596,110 to Weiler, from conventional molding materials
such as polyethylene, polypropylene, and the like, compatible with
the contemplated container contents.
[0024] Container 10 is but one example of such a container,
inasmuch as a wide variety of container shapes and sizes can be
fabricated. Container 10 includes a hollow body portion 12 having a
bottom portion 14 and a top portion 16. The container body portion
12 is filled with a suitable liquid contents or solution 13. A
medicament containing insert assembly 46 is received in a socket 44
provided in a neck portion 38 of the container 10. A severable
overcap 48 envelops the upper part of insert assembly 46. The
bottom portion 14 of the container 10 terminates in a dispensing
nozzle 18 which is in fluid flow communication with the container
body portion 12 and the liquid contents 13 therein.
[0025] As shown in FIGS. 1, 2 and 3, at the top portion 16, the
container body portion 12 terminates in the neck portion 38 unitary
therewith which includes a generally cylindrical throat portion 40
defining a hollow passageway 42. Socket 44 is defined by throat
portion 40 and is unitary therewith. Socket 44 is sized to receive
the insert assembly 46. Severable overcap 48 envelops insert
assembly 46 and is delineated from the socket 44 by a frangible web
49. Preferably, overcap 48 includes two spaced apart unitary and
diametrically opposed grasping wings 50 and 52 to facilitate
removal of the overcap 48 when the container 10 is prepared for
use.
[0026] Insert assembly 46 is a separately fabricated assembly
adapted to be inserted, immobilized and subsequently sealed within
the socket 44 of the container 10 using a top insertion method
disclosed in, for example, U.S. Pat. No. 4,596,110 to Weiler and
U.S. Pat. No. 4,707,966 to Weiler et al. The insert assembly 46 may
be made of the same type of material as the container 10, i.e.,
polyethylene or polypropylene, but can also be molded from a
different material such as acrylonitrile-butadiene-styrene (ABS),
and the like.
[0027] Referring to FIGS. 2 and 3, the insert assembly 46 includes
a base member 54 which is immobilized and sealed in the socket 44
of the container 10. The base member 54 defines a medicament pocket
70 and includes first and second collars 56 and 58, first and
second shoulders 60 and 62 and a hollow neck 64. The shoulder 60
extends between the collars 56 and 58 while the shoulder 62 extends
between the collar 58 and the neck 64. The base member 54 includes
an outer surface 66 and defines a generally cylindrical inner
passageway 68 which extends through the collars 56 and 58 and the
neck 64 and defines the pocket 70 which terminates in a proximal
generally circular aperture 72 occluded by a rupturable membrane
76.
[0028] Interior face 77 of rupturable membrane 76 seals the
interior of the pocket 70 from the container 10. The rupturable
membrane 76 is unitary with and is made of the same material as the
base member 54. The thickness of the material forming the membrane
76 is selected to provide both good sealing and piercing
characteristics.
[0029] Medicament 78 is stored in the pocket 70 and is sealed from
the container body 12 by the membrane 76. Medicament 78 can be, for
example, a capsule, a tablet, a pill, or an aliquot of powder, as
desired.
[0030] The neck 64 of the base member 54 additionally includes a
distal flange 80 extending radially outwardly from the outer
surface 66 adjacent the distal opening 74. The neck 64 also
includes first and second annular ribs 82 and 84 extending
outwardly from, and circumferentially around, the outer surface 66.
The rib 82 is positioned parallel to, and spaced from, the flange
80 so as to define a groove 86 therebetween. The rib 84 is
positioned parallel to, and spaced from, the shoulder 62 so as to
define a groove or pocket 88 therebetween.
[0031] The insert assembly 46 also includes a plunger 90 movably
received in passageway 68 defined in base member 54. Plunger 90
includes a generally cylindrically shaped head unitary with body
portion 93 which extends into the passageway 68 of the member 54.
The proximal end 94 of plunger 90 has a distal radial end face 96
and an outer surface 98 which abuts and slides against the inner
surface of the base member 54 that defines the passageway 68.
[0032] The solid medicament 78 is stored in the pocket 70 so that
it is retained between the end face 96 of the plunger 90 and the
membrane 76. The radial end face 96 also can include a pair of
spaced-apart prongs 86 and 88 extending outwardly therefrom which
define a cradle for the medicament 78. An elongate piercing blade
104 extends from the radial end face 96 outwardly toward the
membrane 76. Outer face 106 of blade 104 slides along passageway 68
of the base member 54. The blade 104 terminates in a pointed tip
108 which is adapted to pierce and partially sever the membrane 76
when the plunger 90 is urged against the membrane 76.
[0033] Cap 109 of plunger 90 is unitary with the proximal end 94 of
plunger body portion 93 and comprises an annular flange 110 which
extends radially outwardly from the outer surface 98 of the plunger
body portion 93 adjacent the proximal end 94 thereof. A
circumferential wall 112 depends generally downwardly from the
flange 110. The wall 112 is spaced from and generally parallel to
the outer surface 98 of the plunger body portion 93 and defines a
circumferential hollow sleeve 114 between the wall 112 and the
outer surface 98. Annular flange 110 provides a stop as the plunger
90 is urged against the membrane 76. The membrane 76 is not fully
severed from the base member 54 when medicament 78 is dispensed so
as to keep the membrane 76 from dropping into the container 10
along with the medicament 78.
[0034] The wall 112 includes an inner surface 116 and a peripheral
distal end 118. A finger 120 extends circumferentially and radially
inwardly from the inner surface 116 adjacent the peripheral distal
end 118 thereof and abuts retaining rib 82.
[0035] As shown in FIGS. 1, 9 and 10, the nozzle 18 at the bottom
of container 10 is hollow, generally frustoconical in shape, and at
distal end 20 defines an axial dispensing aperture 22. A unitary
but removable dispensing cap member 26 is attached to the bottom
distal end 20 of the nozzle 18. Dispensing member 26 includes a
generally cylindrically shaped twist-off cap 27 including a
circumferential lip or edge 28 which is unitary with the lip 24 of
the nozzle 18. The lip 24 is delineated from the lip 28 by a
circumferential frangible web 30 unitary therewith.
[0036] Dispensing member 26 additionally includes a flat lower base
32 which is unitary with the cap 27 and wings 34 and 36 extending
upwardly from opposite ends of the base 32 and on opposite sides of
the nozzle 18 in a diametrically opposed relationship.
[0037] The use and operation of the container 10 and the insert
assembly 46 thereof for storing, dispensing and thereafter mixing
the medication 78 with a liquid 13 in the container body 12 will
now be described with reference to FIGS. 2-5, 9 and 10.
[0038] Initially, the overcap 48 is severed and removed from the
container 10 to obtain access to the insert assembly 46 and the
plunger 90 thereof. This is achieved by grasping the wings 50 and
52 of the overcap 48 and then exerting a substantially simultaneous
twisting and lifting motion to the overcap 48 so as to break the
unitary frangible web 49 (FIG. 2) between overcap 48 and container
top portion 16.
[0039] FIG. 3 shows the container 10 with the overcap 48 removed
therefrom. The plunger 90 of the insert assembly 46 is in its
normal upright locked position where the finger 120 on the cap 109
of the plunger 90 is lodged in the pocket 86 defined on the neck 64
of the member 54 between flange 80 and retaining rib 82.
[0040] FIG. 4 depicts the top of the container 10 and the insert
assembly 46 after the plunger 90 has been partially depressed
downwardly in the direction of the base member 54. The finger 120
has been dislodged from the pocket 86 and has passed over the rib
82 on the neck 64 into a position where the finger 120 is located
between the ribs 82 and 84 on the neck 64. The depression of the
plunger 90 also causes the downward movement of the elongate blade
104 extending outwardly from the end of the head 92 which, in turn,
causes the tip 108 thereof to contact and pierce the membrane
76.
[0041] The continued downward axial movement of the plunger 90 in
the direction of the base member 54 into the position of FIG. 5
where the finger 120 of the plunger 90 is lodged in the pocket 88
on the neck 64 of the base member 54 causes the further downward
movement of the plunger body portion 93 through the pocket 70
which, in turn, causes the medicament 78 to be pushed out of the
pocket 70 through the now open aperture 72 in the base member 54
and into the container body 12 where the medicament 78 is dissolved
and mixed in the liquid 13. The pierced membrane remains with the
base member 54, however.
[0042] The container 10 at this point can be shaken to allow the
composition of the medicament 78 to be thoroughly distributed in
the liquid 13. The container 10 then can be turned upside down into
a position where the dispensing nozzle 18 faces up and the
dispensing member 26 is severed and removed from the nozzle 18 by
grasping the wings 34 and 36 thereof and then exerting a
simultaneous twisting and lifting motion to break the frangible web
30. The container 10 is then returned to the dispensing position of
FIG. 7 for dispensing the liquid mixture.
[0043] FIGS. 6 and 7 depict an alternate insert assembly, generally
designated 246, which includes a plunger 290 with a plunger body
portion 293 provided with external threads 295 that engage mating
internal threads 297 formed in the base member 254 along the inner
surface which defines a central passageway 268 thereof. In such a
case, the plunger body portion 293 is urged against the membrane
276 by turning rather than pushing to partially sever the membrane
276 from base member 254.
[0044] The insert assembly 246 also differs in structure from the
insert assembly 46 in that the outer surface 298 of plunger body
portion 293 includes a knurled flange portion 299 which extends
radially outwardly therefrom adjacent the proximal end 294 and
allows the plunger body portion 293 to be easily grasped and
turned.
[0045] A second flange portion 301 extends radially outwardly from
the outer surface 298 in a parallel and spaced relationship
relative to the knurled flange portion 299. The flange portion 301
defines a radial shoulder 303 which, as shown in FIG. 7, is adapted
to abut against the shoulder 262 defined at the proximal end 263 of
the base member 254 to limit the depth to which the plunger body
portion 293 can be threaded into the passageway 268 defined in the
base member 254.
[0046] The membrane 276 differs in structure from the membrane 176
associated with the insert assembly 46 in that the membrane 276
includes a peripheral portion 277 which is thinner than a central
portion 279 thereof to further enhance the piercing of the membrane
276 by the tip or edge 208 of the piercing blade 204 which extends
downwardly from the distal end face 296 of the plunger body portion
293.
[0047] The plunger 290 of the insert assembly 246 additionally
differs in structure from the plunger 90 of the insert assembly 46
in that the plunger 290 includes an interior cavity 305 which
terminates in an opening 307 in the distal end face 296 thereof.
The opening 307 defines a cradle for the medicament tablet 278
housed in the pocket 270 in a manner similar to the cradle defined
by the prongs 86 and 88 of the base member 54 of the insert
assembly 46.
[0048] The other elements and features of the alternate insert
assembly 246 are similar to the elements and features of the insert
assembly 46.
[0049] FIG. 8 depicts yet a further alternate container embodiment
310 including an insert assembly 346 which is similar in structure
and function to the insert assembly 246 shown in FIGS. 6 and 7. The
container embodiment 310 further includes a severable overcap 348
with grasping wings 350 and 351 unitary therewith. Overcap 348 is
similar in structure to the overcap 48 shown in FIGS. 1 and 2,
except that the thermoplastic material forming the overcap 348 also
defines a container top portion 422 and stays together with body
portion 393 of plunger 390 as body portion 393 is turned. In this
particular embodiment, overcap 348 need not be removed in order to
activate plunger 390. Flange portions 399 and 401 receive
therebetween inwardly extending flange or ring 425 of the material
that forms overcap 348.
[0050] The thermoplastic material forming the overcap 348 is
brought into intimate and abutting relationship with the outer
surface of the plunger 390 and the groove 426 defined therein by
flange portions 399 and 401 during the molding of the container 310
and, more particularly, after the insertion and sealing of the
insert assembly 346 as is known in the art and shown in U.S. Pat.
No. 4,596,110 to Weiler and U.S. Pat. No. 4,707,966 to Weiler et
al.
[0051] As a result, the overcap 348 is permanently secured to the
plunger 390 such that, when the overcap 348 is twisted to break the
unitary frangible web 349, the plunger 390 turns with the overcap
348. The subsequent turning of the overcap 348, in turn, causes the
downwardly movement of the plunger 390 into piercing and severing
contact with the membrane 376 in the same manner as described above
with respect to the plunger embodiment 290 to dispense medicament
378.
[0052] What has thus been disclosed and described are containers
including alternate insert assemblies which house and subsequently
dispense a medicament into the container body thus eliminating the
risk of contamination which can result when medicaments are handled
or exposed to non-sterile environments prior to being mixed with a
carrier liquid.
* * * * *