Information
-
Patent Grant
-
6387073
-
Patent Number
6,387,073
-
Date Filed
Wednesday, December 6, 200023 years ago
-
Date Issued
Tuesday, May 14, 200222 years ago
-
Inventors
-
Original Assignees
-
Examiners
- Derakshani; Philippe
- Bui; Thach H
Agents
-
CPC
-
US Classifications
Field of Search
US
- 222 81
- 222 83
- 222 129
- 206 219
- 206 221
- 206 222
- 215 DIG 8
-
International Classifications
-
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.
Description
FIELD OF THE INVENTION
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
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.
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.
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
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.
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.
The medicament can be a tablet, a capsule, a pill, an aliquot of a powder, and the like.
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.
Other advantages and features of the present invention will be more readily apparent from the following detailed description of the preferred embodiment of the invent ion, the accompanying drawings, and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings,
FIG. 1
is a perspective view of a hermetically sealed container embodying the present invention;
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;
FIG. 3
is a cross-sectional view of the container socket and insert;
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;
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;
FIG. 6
is an enlarged, partial front sectional view of an alternate insert assembly embodying the present invention;
FIG. 7
is a view similar to FIG.
6
and showing a medicament being dispensed;
FIG. 8
is an enlarged, front sectional view of an alternate container embodying the present invention;
FIG. 9
is an enlarged partial front elevational view, partially broken away, and showing the dispensing nozzle of the container; and
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
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 illustrate embodiments.
For ease o description, the container of the present invention will be described in a normal (upright) operating position and terms such as upper, lower, horizontal, etc., %ill 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.
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.
Container
10
is but one example of such a container, inasmuch as a wide variety of contain r 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.
As shown
FIGS. 1
,
2
and
3
, at the top portion
16
, the container body portion
1
terminates in the neck portion
38
unitary therewith which includes a general cylindrical throat portion
40
defining a hollow passageway
42
. Socket
4
A 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.
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.
Referring t
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 rupturable membrane
76
.
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.
Medicament it
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.
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 defme a groove or pocket
88
therebetween.
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
o 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
.
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 c,n include a pair of spaced-apart prongs
86
and
88
extending outwardly therefrom which defme 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
5
. 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
.
Cap
109
o plunger
90
is unitary with the proximal end
94
of plunger body portion
93
d comprises an annular flange
110
which extends radially outwardly from t e 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 cuter 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 flan ye
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
.
The wall
112
includes an inner surface
116
and a peripheral distal end
118
. A finger
120
e tends circumferentially and radially inwardly from the inner surface
116
adjacent the peripheral distal end
118
thereof and abuts retaining rib
82
.
As shown n
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.
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.
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
.
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 achieve 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
.
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 n the neck
64
of the member
54
between flange
80
and retaining rib
82
.
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
.
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.
The container
10
at this point can be shaken to allow the composition of the medicament
78
to be thoroughly distributed in the liquid
11
. 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.
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
27
by turning rather than pushing to partially sever the membrane
276
from base member
254
.
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
29
which extends radially outwardly therefrom adjacent the proximal end
294
and allows the plunger body portion
293
to be easily grasped and turned.
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
.
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
.
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
.
The other elements and features of the alternate insert assembly
246
are similar to the elements and features of the insert assembly
46
.
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
24
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
.
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
10
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.
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
.
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.
Claims
- 1. A hermetically sealed container which comprises:a container body portion which terminates at one end into a hollow neck portion that defines a socket; a medicament bearing insert assembly sealingly received in said socket and including a base member permanently 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; 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 container body portion terminates at an opposite end in a dispensing nozzle and the plunger is slidably movable into said pocket to pierce the membrane.
- 4. The container in accordance with claim 1 wherein the base member includes internal threads which engage external threads on the plunger and 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 made of thermoplastic material forming a ring which is brought into intimate and abutting relationship with a groove formed in the plunger so that 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.
- 6. The container in accordance with claim 1 wherein the medicament is in the form of a capsule and the plunger includes a radial end face defining a cradle for the capsule.
- 7. The container in accordance with claim 6 wherein the cradle is defined by a pair of spaced-apart prongs extending outwardly from the radial end face of the plunger.
- 8. The container in accordance with claim 6 wherein the cradle is defined by a cavity in the plunger which terminates in an opening in the radial end face of the plunger.
US Referenced Citations (28)