U.S. patent application number 11/523306 was filed with the patent office on 2007-05-10 for specimen enclosure apparatus and containers and closure devices for the same.
This patent application is currently assigned to bioMerieux. Invention is credited to Sylvain Baeyaert, Bruno Colin, Ron Robinson, Chris Ronsick, Mark Wilson.
Application Number | 20070102393 11/523306 |
Document ID | / |
Family ID | 37594987 |
Filed Date | 2007-05-10 |
United States Patent
Application |
20070102393 |
Kind Code |
A1 |
Colin; Bruno ; et
al. |
May 10, 2007 |
Specimen enclosure apparatus and containers and closure devices for
the same
Abstract
Embodiments of the present invention include a specimen
enclosure apparatus. The specimen enclosure apparatus includes a
container having a cavity configured to receive the specimen and an
opening extending through a neck of the container to the cavity. An
internal flange is positioned intermediate the neck of the
container. The specimen enclosure apparatus further includes a
closure device configured to be received in the opening. The
closure device has a flange seal portion configured to contact the
internal flange to form a flange seal proximate the cavity and
further has a radial travel limiter integrally formed with the
closure device that is configured to contact the container in the
opening to limit radial movement of the flange seal portion
relative to the internal flange. Containers and closure devices are
also provided.
Inventors: |
Colin; Bruno; (Marcy
I'Etoile, FR) ; Baeyaert; Sylvain; (Saint Genis Les
Ollieres, FR) ; Ronsick; Chris; (Durham, NC) ;
Wilson; Mark; (Hillsborough, NC) ; Robinson; Ron;
(Durham, NC) |
Correspondence
Address: |
BIOMERIEUX, INC.
PATENT DEPARTMENT
100 RODOLPHE STREET
DURHAM
NC
27712
US
|
Assignee: |
bioMerieux
|
Family ID: |
37594987 |
Appl. No.: |
11/523306 |
Filed: |
September 19, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60718655 |
Sep 20, 2005 |
|
|
|
Current U.S.
Class: |
215/249 ;
215/355 |
Current CPC
Class: |
B65D 45/322 20130101;
B01L 2300/042 20130101; B65D 39/0005 20130101; B65D 51/241
20130101; B01L 2300/049 20130101; B01L 2300/048 20130101; B65D
41/16 20130101; B01L 3/50825 20130101 |
Class at
Publication: |
215/249 ;
215/355 |
International
Class: |
B65D 51/00 20060101
B65D051/00; B65D 39/00 20060101 B65D039/00 |
Claims
1. A specimen enclosure apparatus, comprising: a container having a
cavity configured to receive the specimen and an opening extending
through a neck of the container to the cavity; an internal flange
positioned intermediate the neck of the container; and a closure
device configured to be received in the opening, the closure device
having a flange seal portion configured to contact the internal
flange to form a flange seal proximate the cavity and having a
radial travel limiter integrally formed with the closure device
that is configured to contact the container in the opening to limit
radial movement of the flange seal portion relative to the internal
flange.
2. The apparatus of claim 1, wherein the neck further comprises a
plug sealing cylindrical surface extending from proximate the
internal flange away from the cavity and wherein the radial travel
limiter comprises a mating plug sealing cylindrical surface
configured to form a plug seal with the plug sealing cylindrical
surface of the neck, the flange seal being positioned between the
plug seal and the cavity.
3. The apparatus of claim 2, wherein the flange seal comprises an
internal flange seal and wherein the container further comprises an
external flange positioned at an end of the neck away from the
cavity and wherein the closure device further comprises an external
flange seal portion configured to contact the external flange to
form an external flange seal at the end of the neck with the plug
seal being positioned between the external flange seal and the
internal flange seal.
4. The apparatus of claim 2, wherein the closure device is
positioned in the opening and wherein the apparatus further
comprises a closure member extending over the closure device and
coupled to the container that retains the closure device in the
opening and compresses the flange seal.
5. The apparatus of claim 4, wherein the closure member comprises a
crimp seal, a screw cap and/or a tear-off seal.
6. The apparatus of claim 2, wherein the closure device is
positioned in the opening and wherein an edge of the flange seal
adjacent the opening is positioned to be directly exposed to moist
heat during sterilization.
7. The apparatus of claim 2, wherein the closure device is
positioned in the opening and wherein the closure device further
comprises a degassing extension member extending from the flange
seal portion into the cavity that is configured to retain the
closure device in a degassing position in the opening defining a
passage from the cavity through the opening through which a gas may
be moved into and out of the cavity.
8. The apparatus of claim 7, wherein the degassing extension member
includes a plurality of tabs extending from an exterior surface
thereof configured to engage the neck in the opening to retain the
closure device in the degassing position and to displace the
exterior surface of the degassing extension member from the neck to
define the passage from the cavity through the opening.
9. The apparatus of claim 8, wherein an edge of the flange seal
adjacent the opening is positioned to be directly exposed to moist
heat during sterilization.
10. A specimen enclosure apparatus, comprising: a container having
a cavity configured to receive the specimen and an opening
extending through a neck of the container to the cavity; and a
closure device covering the opening, the closure device having a
flange seal portion configured to contact an external flange seal
portion on an end of the neck of the container displaced from the
cavity to form a flange seal closing the opening and having a
radial travel limiter integrally formed with the closure device
that contacts an exterior surface of the neck to limit radial
movement of the flange seal portion of the closure device relative
to the external flange seal portion of the container.
11. The apparatus of claim 10, wherein the apparatus further
comprises a closure member coupled to the container that retains
the closure device covering the opening and compresses the flange
seal.
12. The apparatus of claim 11, wherein the closure member comprises
a crimp seal, a screw cap and/or a tear-off seal.
13. The apparatus of claim 10, wherein an edge of the flange seal
adjacent the opening is positioned to be directly exposed to moist
heat during sterilization.
14. The apparatus of claim 10, wherein the closure device further
comprises a degassing extension member extending from the flange
seal portion along an exterior surface of the neck that is
configured to retain the closure device in a degassing position
defining a passage from the cavity through the opening through
which a gas may be moved into and out of the cavity.
15. The apparatus of claim 14, wherein the degassing extension
member includes a tab extending from a surface thereof configured
to engage the exterior surface of the neck to retain the closure
device in the degassing position.
16. The apparatus of claim 15, wherein the tab comprises a
circumferentially extending ridge and wherein the degassing
extension member further comprises a slot extending past the ridge
to define the passage along the exterior surface of the neck.
17. The apparatus of claim 10, wherein the neck further comprises a
plug sealing cylindrical surface defined by the exterior surface of
the neck and wherein the radial travel limiter comprises a mating
plug sealing cylindrical surface configured to form a radial seal
with the plug sealing cylindrical surface of the neck, the flange
seal being positioned between the radial seal and the cavity.
18. The apparatus of claim 17, wherein the apparatus further
comprises a closure member coupled to the container that retains
the closure device covering the opening and compresses the flange
seal.
19. The apparatus of claim 17, wherein the closure member further
compresses the radial seal.
20. The apparatus of claim 17, wherein the neck further includes a
narrowed portion and an intermediate portion extending from the
narrowed portion to the plug sealing cylindrical surface and
wherein the closure member engages the intermediate portion to
retain the closure device.
21. The apparatus of claim 1, wherein the closure member comprises
a crimp seal, a screw cap and/or a tear-off seal.
22. A container for a specimen enclosure apparatus, the container
comprising: a main portion including a cavity configured to receive
the specimen; a neck extending from the main portion; an opening
extending through the neck to the cavity; an internal flange
positioned intermediate the neck of the container that is
configured to contact a flange seal portion of a closure device to
form a flange seal proximate the cavity; and a radial travel
limiting contact surface in the opening that is configured to
contact the closure device to limit radial movement of the flange
seal.
23. The container of claim 22, wherein the radial travel limiting
contact surface comprises a plug sealing cylindrical surface
extending from proximate to the internal flange away from the
cavity that is configured to form a plug seal with the closure
device.
24. The container of claim 23, further comprising an external
flange positioned at an end of the neck away from the cavity that
is configured to contact the closure device to form an external
flange seal, the plug seal being positioned between the flange seal
formed by the internal flange and the external flange seal.
25. A closure device for a specimen enclosure apparatus, the
closure device comprising: a flange seal portion configured to
contact an internal flange positioned intermediate a neck of a
container configured to receive the specimen to form a flange seal
proximate the cavity; and a radial travel limiter integrally formed
with the flange seal portion that is configured to contact the
container in an opening extending through the neck to the cavity to
limit radial movement of the flange seal portion relative to the
internal flange.
26. The closure device of claim 25, wherein the radial travel
limiter comprises a mating plug sealing cylindrical surface
extending from the flange seal portion that is configured to form a
plug seal with a plug sealing cylindrical surface extending from
the internal flange of the container away from the cavity of the
container.
27. The closure device of claim 26, further comprising an external
flange seal portion configured to form a further flange seal with
an external flange of the container positioned at an end of the
neck away from the cavity, the plug seal being positioned between
the flange seal and the further flange seal.
28. The closure device of claim 26, further comprising a degassing
extension member extending from the flange seal portion and away
from the radial travel limiter that is configured to retain the
closure device in a degassing position in the opening defining a
passage from the cavity through which a gas may be moved into and
out of the cavity.
29. The closure device of claim 28, wherein the degassing extension
member includes a plurality of tabs extending from an exterior
surface thereof configured to engage the neck in the opening to
retain the closure device in the degassing position and to displace
the exterior surface of the degassing extension member from the
neck to define the passage.
Description
RELATED APPLICATION
[0001] The present application claims the benefit of and priority
from U.S. Provisional Application No. 60/718,655, (Attorney Docket
No. 01072), filed Sep. 20, 2005, the disclosure of which is hereby
incorporated herein in its entirety by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to apparatus for enclosing a
specimen, reagants and components thereof. In particular, the
present invention relates to an apparatus for enclosing a specimen
that can be used in a microbial detection and/or characterization
system.
[0003] Various apparatus for enclosing specimens are known in the
art. Typically, such apparatus include a specimen container or
bottle and a closure or stopper for the specimen container or
bottle. Further, several types of closures are known for use with
specimen containers or bottles. A standard closure, for example,
for medical vials is a rubber stopper. A rubber stopper can seal a
vial or bottle by either a plug seal or a flange seal. A plug seal
may be provided by compressing the rubber stopper in the neck of a
bottle. FIGS. 1A and 1B show a simple plug stopper 100 where the
plug seal 106 is defined by contact between the cylindrical surface
of the stopper 100 and the neck 108 of the bottle 102. The closure
holding the stopper in the bottle is not shown in FIGS. 1A and 1B.
The stopper 100 may be sealed in the neck 108 of the bottle 102 by
radial R compression. This compression may be induced by the
interference of the stopper 100 with the bottle neck 108. The
stopper plug 100 may, therefore, have an outer diameter greater
than the inner diameter of the neck 108 of the bottle to cause the
stopper 100 to be compressed. This plug seal 106 may also be
referred to as a valve seal.
[0004] A flange seal 104 may be created by contact between a flange
104a, which is the horizontal surface of the stopper, and a top
horizontal surface 104b of the bottle 102. The compression where
these two surfaces mate may be provided by a closure member, which
may be applied over the stopper 100 and onto the bottle 102.
Examples of these closures may be a crimp seal, a screw cap or a
tear-off seal. The stopper 100 may seal to the top surface 104b of
the bottle 102 by being compressed by the closure. In contrast to a
plug seal, which typically relies on geometric interference with
the bottle, a flange seal is generally compressed by the closure
and this sealing force (compression) can generally be controlled by
the equipment that applies the stopper.
[0005] Lyophilization stoppers are another known type of stopper
used in the pharmaceutical industry. Typically, these stoppers 110
contain a slot 114 in the stopper legs 116 as seen in FIGS. 2A
through 2C. The stopper 110 may be held above the vial 112 by
protruding nibs 118, which position (FIG. 2C) allows gas to be
evacuated from the vial 112 through the slots 114 in the stopper
110. At the end of the degassing process, the stopper 110 may be
pressed into the vial (bottle) 112 and seal the bottle 112 through
a flange and/or a plug seal (FIG. 2A). A plug seal and flange seal
have been described above. The limitations of a standard
lyophilization stopper depend on the applications of the product.
The standard lyophilization stopper typically has two legs 116 that
deflect in towards the bottle 112 due to the compression of the
stopper 110 into the bottle 112. This can be seen in a finite
element analysis model shown in FIG. 3. Due to the plug seal and
the geometric interference, the legs 116 of the stopper 110
generally deflect in towards the center of the vial. The vial is
not shown for clarity. The stopper and crimp shown above are
modeled in a cross section in FIG. 3, because the boundary and load
conditions in FIG. 3 are symmetric about the center plane.
[0006] For aseptic product applications, which generally use
autoclave terminal sterilization, the movement of the surface
contact (interface) between the stopper and bottle or vial can make
it difficult to sterilize this interface. In an autoclave process,
the product is typically placed into an autoclave and steam heats
the product for at least 15 minutes at 121.degree. C. The steam
outside the product transfers heat to the interior contents of the
vial, which heat vaporizes moisture in the vial. This moist heat is
then transferred to the inner surfaces of the bottle, which kill
microorganisms and spores. The rate of kill for microorganisms
(bacteria, molds etc) depends on the amount of time exposed to this
moist heat. For an effective rate of lethality, the microorganisms
typically are exposed directly to moist heat (steam). FIG. 4
illustrates two zones where moist and dry heat may be transferred
to the stopper/vial interface. As can be seen in FIG. 4, steam from
the heated moisture inside the vial does not penetrate into first
zone 124, as the stopper 120 is compressed against the bottle 122
in the first zone 124. Dry heat may still be transferred to this
area 124 and this area 124 may still reach the temperature of the
autoclave (standard cycle temperature 121.degree. C.). However, dry
heat is generally not as effective at killing microorganisms as
moist heat. The second zone 126 is exposed directly with moist heat
due to clearance between the stopper 120 and the bottle (vial)
122.
[0007] In addition to lyophilization stoppers, which generally seal
with a plug and a flange seal, septums may also be used to seal a
vial. This type of stopper/seal may be a circular elastomeric
material. An advantage of a septum (flange) seal is that there is
no plug seal. The plug seal may move away from the bottle neck
during shipping or rough handling. In addition, the contact area of
a plug seal may change with pressure inside the bottle or vary with
the crimping pressure on the stopper. If the contact area changes
after the product is terminally sterilized in an autoclave,
microorganisms trapped in the plug seal may come into contact with
the product.
[0008] A septum stopper may eliminate the problems with a plug seal
as no plug seal is provided. However, a plug seal may be beneficial
to retaining the seal integrity of the product. In addition, a plug
seal may be more stable in the vial than the flange only seal of a
septum stopper. A septum stopper generally may move radially, as
there is no plug seal preventing this radial movement. This radial
movement may break the integrity of the flange seal between the
septum and vial. Secondly, the plug seal may be more stable in the
bottle during the assembly of the stopper to the vial. A crimp seal
placed over the septum may move the septum and compromise the seal
integrity. FIG. 5 shows the cross-section of a septum 130 forming a
flange seal with a bottle (vial) 132. The illustrated flange seal
is between the flat surface of the septum 130 and the top surface
134 of the vial 132. A closure (not shown) compresses the septum
130 on top of the vial 132.
SUMMARY OF THE INVENTION
[0009] Embodiments of the present invention include a specimen
enclosure apparatus. The specimen enclosure apparatus includes a
container having a cavity configured to receive the specimen and an
opening extending through a neck of the container to the cavity. An
internal flange is positioned intermediate the neck of the
container. The specimen enclosure apparatus further includes a
closure device configured to be received in the opening. The
closure device has a flange seal portion configured to contact the
internal flange to form a flange seal proximate the cavity and
further has a radial travel limiter integrally formed with the
closure device that is configured to contact the container in the
opening to limit radial movement of the flange seal portion
relative to the internal flange.
[0010] In further embodiments, the neck further includes a plug
sealing cylindrical surface extending from proximate the internal
flange away from the cavity. The radial travel limiter is a mating
plug sealing cylindrical surface configured to form a plug seal
with the plug sealing cylindrical surface of the neck. The flange
seal is positioned between the plug seal and the cavity.
[0011] In other embodiments, the flange seal is an internal flange
seal and the container further includes an external flange
positioned at an end of the neck away from the cavity. The closure
device further includes an external flange seal portion configured
to contact the external flange to form an external flange seal at
the end of the neck. The plug seal is positioned between the
external flange seal and the internal flange seal.
[0012] In further embodiments, the closure device is positioned in
the opening and the apparatus further includes a closure member
extending over the closure device and coupled to the container that
retains the closure device in the opening and compresses the flange
seal. The closure member may be a crimp seal, a screw cap and/or a
tear-off seal. An edge of the flange seal adjacent the cavity may
be positioned to be directly exposed to moist heat during
sterilization of the apparatus.
[0013] In other embodiments, the closure device further includes a
degassing extension member extending from the flange seal portion
into the cavity that is configured to retain the closure device in
a degassing position in the opening defining a passage from the
cavity through the opening through which a gas may be moved into
and out of the cavity. The degassing extension member may include a
plurality of tabs extending from an exterior surface thereof
configured to engage the neck in the opening to retain the closure
device in the degassing position and to displace the exterior
surface of the degassing extension member from the neck to define
the passage from the cavity through the opening.
[0014] In yet further embodiments, specimen enclosure apparatus
include a container having a cavity configured to receive the
specimen and an opening extending through a neck of the container
to the cavity and a closure device. The closure device covers the
opening and has a flange seal portion configured to contact an
external flange seal portion on an end of the neck of the container
displaced from the cavity to form a flange seal closing the
opening. The closure device further has a radial travel limiter
integrally formed with the closure device that contacts an exterior
surface of the neck to limit radial movement of the flange seal
portion of the closure device relative to the external flange seal
portion of the container. The apparatus may further include a
closure member coupled to the container that retains the closure
device covering the opening and compresses the flange seal.
[0015] In other embodiments, the closure device further includes a
degassing extension member extending from the flange seal portion
along an exterior surface of the neck that is configured to retain
the closure device in a degassing position defining a passage from
the cavity through the opening through which a gas may be moved
into and out of the cavity. The degassing extension member may
include a tab extending from a surface thereof configured to engage
the exterior surface of the neck to retain the closure device in
the degassing position. The tab may be a circumferentially
extending ridge and the degassing extension member may further
include a slot extending past the ridge to define the passage along
the exterior surface of the neck.
[0016] In further embodiments, the neck further includes a plug
sealing cylindrical surface defined by the exterior surface of the
neck and the radial travel limiter is a mating plug sealing
cylindrical surface configured to form a radial seal with the plug
sealing cylindrical surface of the neck, the flange seal being
positioned between the radial seal and the cavity. The apparatus
may further include a closure member coupled to the container that
retains the closure device covering the opening and compresses the
flange seal. The closure member may further compress the radial
seal. The neck may further include a narrowed portion and an
intermediate portion extending from the narrowed portion to the
plug sealing cylindrical surface and the closure member may engage
the intermediate portion to retain the closure device.
[0017] In yet other embodiments, containers for a specimen
enclosure apparatus include a main portion including a cavity
configured to receive the specimen and a neck extending from the
main portion. An opening extends through the neck to the cavity. An
internal flange is positioned intermediate the neck of the
container that is configured to contact a flange seal portion of a
closure device to form a flange seal proximate the cavity. A radial
travel limiting contact surface is provided in the opening that is
configured to contact the closure device to limit radial movement
of the flange seal. The radial travel limiting contact surface may
be a plug sealing cylindrical surface extending from proximate to
the internal flange away from the cavity that is configured to form
a plug seal with the closure device. The container may further
include an external flange positioned at an end of the neck away
from the cavity that is configured to contact the closure device to
form an external flange seal, the plug seal being positioned
between the flange seal formed by the internal flange and the
external flange seal.
[0018] In further embodiments, closure devices for a specimen
enclosure apparatus include a flange seal portion configured to
contact an internal flange positioned intermediate a neck of a
container configured to receive the specimen to form a flange seal
proximate the cavity and further include a radial travel limiter.
The radial travel limiter is integrally formed with the flange seal
portion and is configured to contact the container in an opening
extending through the neck to the cavity to limit radial movement
of the flange seal portion relative to the internal flange. The
radial travel limiter may be a mating plug sealing cylindrical
surface extending from the flange seal portion that is configured
to form a plug seal with a plug sealing cylindrical surface
extending from the internal flange of the container away from the
cavity of the container. The closure device may further include an
external flange seal portion configured to form a further flange
seal with an external flange of the container positioned at an end
of the neck away from the cavity, the plug seal being positioned
between the flange seal and the further flange seal.
[0019] In yet other embodiments, the closure device further
includes a degassing extension member extending from the flange
seal portion and away from the radial travel limiter that is
configured to retain the closure device in a degassing position in
the opening defining a passage from the cavity through which a gas
may be moved into and out of the cavity. The degassing extension
member may include a plurality of tabs extending from an exterior
surface thereof configured to engage the neck in the opening to
retain the closure device in the degassing position and to displace
the exterior surface of the degassing extension member from the
neck to define the passage.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1A is a cross-sectional view illustrating the flange
and plug areas of a conventional stopper in a specimen bottle.
[0021] FIG. 1B is a bottom perspective view of the stopper of FIG.
1A.
[0022] FIG. 2A is a perspective view illustrating a conventional
lyophilization stopper insert to a sealed position in a specimen
bottle according to the prior art.
[0023] FIG. 2B is a bottom perspective view illustrating the
lyophilization stopper of FIG. 2A.
[0024] FIG. 2C is a perspective view illustrating of the
arrangement of FIG. 2A with the stopper in a degassing
position.
[0025] FIG. 3 illustrates a finite element analysis of the
lyophilization stopper shown in FIG. 2A.
[0026] FIG. 4 is a cross-sectional view illustrating the interface
between a stopper and a vial including two areas of the interface
of a plug seal therebetween according to the prior art.
[0027] FIG. 5 is a cross-sectional view of a conventional septum
forming a flange seal with a vial according to the prior art.
[0028] FIGS. 6A through 6D illustrate a closure device for a
specimen container according to some embodiments of the present
invention.
[0029] FIGS. 6E through 6F illustrate a closure device for a
specimen container according to other embodiments of the present
invention.
[0030] FIG. 6G is a perspective view of a closure device for a
specimen container according to further embodiments of the present
invention.
[0031] FIGS. 7A through 7D illustrate a closure device for a
specimen container according to yet further embodiments of the
present invention.
[0032] FIG. 8 is a perspective view of a specimen container
according to some embodiments of the present invention.
[0033] FIG. 9A is a cross-sectional view of the neck of the
specimen container of FIG. 8.
[0034] FIG. 9B is a cross-sectional view of the neck of
conventional specimen container.
[0035] FIG. 10 is a front elevational view of the specimen
container shown in FIG. 8.
[0036] FIG. 11 is a cross-sectional view of the specimen container
shown in FIG. 8.
[0037] FIG. 12 is a cross-sectional view of the closure device
shown in FIG. 6A placed in the specimen container shown in FIG.
8.
[0038] FIGS. 13A and 14A are cross-sectional views illustrating the
closure devices of FIGS. 6A and 7A, respectively, in the degassing
position in the specimen container shown in FIG. 8.
[0039] FIGS. 13B and 14B are cross-sectional views illustrating the
closure devices of FIGS. 6A and 7A, respectively, in the
sealing/closed position in the specimen container shown in FIG.
8.
[0040] FIG. 15 is a perspective view illustrating a closure device
according to further embodiments of the present invention.
[0041] FIG. 16A is a cross-sectional view illustrating the neck
area of a specimen enclosure apparatus in a degassing position
according to further embodiments of the present invention.
[0042] FIG. 16B is a front perspective view illustrating the neck
area of a specimen enclosure apparatus of FIG. 16A in a
sealed/closed position.
[0043] FIG. 16C is a cross-sectional view illustrating the neck
area of the specimen enclosure apparatus FIG. 16B.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0044] The present invention now will be described more fully
hereinafter with reference to the accompanying drawings, in which
illustrative embodiments of the invention are shown. In the
drawings, the relative sizes of regions or features may be
exaggerated for clarity. This invention may, however, be embodied
in many different forms and should not be construed as limited to
the embodiments set forth herein; rather, these embodiments are
provided so that this disclosure will be thorough and complete, and
will fully convey the scope of the invention to those skilled in
the art.
[0045] It will be understood that, although the terms first,
second, etc. may be used herein to describe various elements,
components, regions, layers and/or sections, these elements,
components, regions, layers and/or sections should not be limited
by these terms. These terms are only used to distinguish one
element, component, region, layer or section from another region,
layer or section. Thus, a first element, component, region, layer
or section discussed below could be termed a second element,
component, region, layer or section without departing from the
teachings of the present invention.
[0046] Spatially relative terms, such as "beneath", "below",
"lower", "above", "upper" and the like, may be used herein for ease
of description to describe one element or feature's relationship to
another element(s) or feature(s) as illustrated in the figures. It
will be understood that the spatially relative terms are intended
to encompass different orientations of the device in use or
operation in addition to the orientation depicted in the figures.
For example, if the device in the figures is turned over, elements
described as "below" or "beneath" other elements or features would
then be oriented "above" the other elements or features. Thus, the
exemplary term "below" can encompass both an orientation of above
and below. The device may be otherwise oriented (rotated 90.degree.
or at other orientations) and the spatially relative descriptors
used herein interpreted accordingly.
[0047] As used herein, the singular forms "a", "an" and "the" are
intended to include the plural forms as well, unless expressly
stated otherwise. It will be further understood that the terms
"includes,""comprises,""including" and/or "comprising," when used
in this specification, specify the presence of stated features,
integers, steps, operations, elements, and/or components, but do
not preclude the presence or addition of one or more other
features, integers, steps, operations, elements, components, and/or
groups thereof. It will be understood that when an element is
referred to as being "connected" or "coupled" to another element,
it can be directly connected or coupled to the other element or
intervening elements may be present. Furthermore, "connected" or
"coupled" as used herein may include wirelessly connected or
coupled. As used herein, the term "and/or" includes any and all
combinations of one or more of the associated listed items.
[0048] Unless otherwise defined, all terms (including technical and
scientific terms) used herein have the same meaning as commonly
understood by one of ordinary skill in the art to which this
invention belongs. It will be further understood that terms, such
as those defined in commonly used dictionaries, should be
interpreted as having a meaning that is consistent with their
meaning in the context of the relevant art and this specification
and will not be interpreted in an idealized or overly formal sense
unless expressly so defined herein.
[0049] Closure devices according to some embodiments of the present
invention will now be described with reference to FIGS. 6A through
6G. FIG. 6A is a perspective view of a closure device 200a. FIG. 6B
is a top plan view, FIG. 6C is a front view, and FIG. 6D is a
bottom plan view of the closure device 200a of FIG. 6A. FIGS. 6E
and 6F show a closure device 200b that differs in the number of
tabs provided relative to the closure device 200a of FIGS. 6A
through 6D (three versus four). The closure device 200c shown in
FIG. 6G differs in that a depression 204 is not included in a top
surface 202 of the closure device. The closure devices (stoppers)
shown in FIGS. 6A-6G may be inserted into a container of a specimen
enclosure apparatus (see FIG. 8) to provide two flange seals and
one plug seal.
[0050] Referring first to FIGS. 6A through 6D, the closure device
200a is illustrated as an elastomeric stopper extending along a
central axis A. As used herein, references to longitudinal will
refer to a direction extending along the central axis A,
circumferential will refer to extending around the central axis A,
and radial will refer to a radial direction as illustrated by the
arrow R in FIG. 6A. The closure device 200a is configured to be
received in an opening to a specimen container, such as illustrated
in FIG. 8. The illustrated closure device 200a includes an internal
flange seal portion 206 and an external flange seal portion 210.
The internal flange seal portion 206 is configured to contact an
internal flange of a specimen container to form a flange seal
proximate the specimen cavity of the container. The external flange
seal portion 210 is configured to contact an external flange of the
container to form an external flange seal at the end of a neck of
the enclosure. The flange seal formed by the internal flange seal
portion 206 has an edge positioned adjacent to the cavity, which is
positioned to be directly exposed to moist heat during
sterilization of the specimen in the container.
[0051] The closure device further includes a radial travel limiter
208, integrally formed with the closure device 200a, that is
configured to contact the specimen container in an opening to the
container to limit radial movement of the flange seal portion 206
relative to the internal flange of the container. More
particularly, as illustrated in FIGS. 6A through 6D, the radial
travel limiter is a mating plug sealing cylindrical surface 208
configured to form a plug seal with a plug sealing cylindrical
surface in the neck of the container. As such, the internal flange
seal formed using the internal flange seal portion 206 is
positioned between the plug seal formed by the mating plug sealing
cylindrical surface 208 and the specimen-containing cavity of the
container when the closure device 200a is inserted in the
container. In other words, as seen in FIG. 12, the closure device
200a may be pressed into the opening in the neck of the container
400 to position an internal flange seal 450 between a cavity 402
and a plug seal 452. As seen in FIG. 12, of the plug seal 452 is
positioned between the internal flange seal 450 and an external
flange seal 454.
[0052] As also seen in the embodiments of FIGS. 6A through 6D, the
closure device 200a includes a degassing extension member 212. The
degassing extension member 212 extends longitudinally towards the
cavity 402 as best seen in FIG. 12. The degassing extension member
212 is configured to retain the closure device 200a in a degassing
position in the opening of the container and to define a passage
460 (FIG. 13A) from the cavity 402 through the opening through
which a gas may be moved into and out of the cavity 402. More
particularly, as illustrated in the embodiments of FIGS. 6A through
6D, the degassing extension member 212 includes a plurality of tabs
214 extending from an exterior surface thereof. The tabs 214 are
configured to engage the neck of the container to retain the
closure device 200a in a degassing position and to displace the
exterior surface of the degassing extension member 212 from the
neck to define a passage from the cavity through the opening.
[0053] In the embodiments illustrated in FIGS. 6A through 6D, a top
surface 202 of the closure device 200a includes a depression 204 in
a central region thereof. The depression 204 may be used, for
example, for insertion of a needle or the like through the closure
device 200a to withdraw a specimen from the cavity 402.
Furthermore, as discussed above, the mating plug sealing
cylindrical surface 208 may be used to form a plug seal.
Accordingly, a diameter of the mating plug sealing surface 208 may
be selected to provide an interference fit with a smaller diameter
opening in the neck of the container to provide a desired
compression of the closure device 200a in forming the plug seal.
Similarly, a closure member 407 (FIG. 13B) as will be discussed
further herein may extend over the closure device 200a and may be
coupled to a container to retain the closure device 200a and to
compress the closure device 200a longitudinally to form flange
seals with the respective flange seal portions 206, 210.
[0054] Referring now particularly to FIG. 6D, it can be seen that a
total of four tabs 214 are provided in the illustrated embodiments.
More particularly, the tabs 214 extend circumferentially a length
defined by the angle .alpha.. Similarly, the respective tabs 214
are displaced from each other (center to center) by an angle
.beta..sub.1, appearing as 90.degree. in FIG. 6D where each of the
four tabs 214 are uniformly located around the circumference of the
closure device 200a. It will be understood that more or less tabs
214 may be used and that the tabs need not be uniformly spaced or
sized in some embodiments. As also shown in FIG. 6D, the degassing
extension member 212 may include a longitudinally extending hollow
core 220. However, it will be understood that the degassing
extension member 212 may be a solid elastomeric member and need not
include the hollow core 220.
[0055] Further embodiments of a closure device 200b are illustrated
in FIGS. 6E through 6G. As shown in the embodiments of FIGS. 6E and
6F, three tabs 214 are provided, each uniformally displaced from
the other tabs by an angle .beta..sub.2, shown as 120.degree. in
FIG. 6F. Note that, as with the description of FIG. 6D above, a
uniform spacing of the tabs 214 may not be provided in other
embodiments of the present invention. The closure device 200b shown
in FIGS. 6E and 6F may operate otherwise substantially as described
with reference to the embodiments of FIGS. 6A through 6D. The
closure device 200c illustrated in FIG. 6G differs in that a top
surface 202' thereof does not include the depression 204 shown in
FIG. 6A. Various like numbered elements in FIG. 6G may otherwise be
described substantially as previously described with reference to
FIGS. 6A through 6F.
[0056] A closure device according to further embodiments of the
present invention will now be described with reference to FIGS. 7A
through 7D. FIG. 7A is a perspective view of a closure device 300.
FIG. 7B is a top plan view, FIG. 7C is a front view, and FIG. 7D is
a bottom plan view of the closure device 300 of FIG. 7A. The
closure device (stopper) 300 shown in FIGS. 7A-7D may be inserted
into a container of a specimen enclosure apparatus (see FIG. 8) to
provide one flange seal and one plug seal. In other words, the
closure device 300 shown in FIGS. 7A through 7D eliminates the top
(external) flange seal, i.e., the flange seal that mates with the
top surface of the vial.
[0057] As seen in the embodiments of FIGS. 7A through 7D, the
closure device 300 extends longitudinally along a central axis A.
The closure device 300 is shown as an elastomeric stopper for
closing a specimen enclosure apparatus. A top surface 302 of the
closure device 300 includes a depression 304 that may be used
substantially as described with reference to the depression 204 of
FIG. 6A. A flange seal portion 306 is configured to contact the
internal flange positioned intermediate a neck of a container
configured to receive the specimen to form a flange seal proximate
a cavity containing the specimen in the container. A radial travel
limiter 308 is integrally formed with the flange seal portion 306.
The radial travel limiter 308 is configured to contact the
container in an opening extending through a neck of the container
to the cavity to limit radial movement of the flange seal portion
306 relative to an internal flange of the container. As more
particularly shown in the embodiments of FIGS. 7A through 7D, the
radial travel limiter is a mating plug sealing cylindrical surface
308 extending from the flange seal portion 306 that is configured
to form a plug seal with a plug sealing cylindrical surface
extending from the internal flange of the container away from the
cavity. This arrangement can be seen, for example, in FIG. 14B
where the closure device 300 is shown inserted in a neck 406 of the
container of the specimen and closure apparatus.
[0058] Also, shown in the embodiments of FIGS. 7A through 7D is a
degassing extension member 312 extending from the flange seal
portion 306 and away from the radial travel limiting mating plug
sealing cylindrical surface 308. The degassing extension member 312
is configured to retain the closure device 300 in a degassing
position in the opening of the container to define a passage 460'
from the cavity 402 through which a gas may be moved into and out
of the cavity as seen in FIG. 14A. More particularly, in the
illustrated embodiments, the degassing extension member 312
includes a plurality of tabs 314 extending from an exterior surface
thereof configured to engage the neck in the opening to retain the
closure device 300 in the degassing position and to displace the
exterior surface of the degassing extension member 312 from the
neck to define the passage 460'.
[0059] As more particularly seen in the view of FIG. 7D, the
illustrated embodiments of FIGS. 7A through 7D include a total of
four uniformly circumferentially placed tabs 314 and the degassing
extension member 312 includes a longitudinally extending hollow
core 320. However, as described previously with reference to the
embodiments of FIGS. 6A through 6G, more or less tabs 314, which
may be uniformly or non-uniformly spaced, may be used in some
embodiments and the degassing extension member 312 may be solid
without the hollow core 320 in some embodiments.
[0060] FIG. 8 illustrates a specimen container 400 or vial
according to some embodiments of the present invention. As will be
described herein, the neck 406 of the container 400 of FIG. 8
includes an internal step, which forms a flange seal with a closure
device as described with reference to FIGS. 6A-6G and 7A-7D.
[0061] A container 400 for a specimen enclosure apparatus according
to some embodiments of the present invention will now be further
described with reference to FIGS. 8, 10 and 11. FIG. 8 is a
perspective view of the container 400, FIG. 10 is a front plan
view, and FIG. 11 is a cross-sectional view of the container 400.
As seen in the embodiments of FIGS. 8, 10 and 11, the container 400
includes a main portion 408 including a cavity 402 configured to
receive the specimen. A neck 406 extends upwardly longitudinally
from the main portion 408. An opening 404 extends through the neck
406 to the cavity 402 defined by the main portion 408.
[0062] An internal flange 410 is positioned intermediate the neck
406 of the container 400. The internal flange 410 is configured to
contact the flange seal portion 206, 306 of the closure device
200a, 200b, 200c, 300 to form a flange seal proximate the cavity
402.
[0063] Also shown in the embodiments of FIGS. 8, 10 and 11 is a
radial travel limiting contact surface 412 in the opening 404. The
radial travel limiting contact surface 412 is configured to contact
the closure device 200a, 200b, 200c, 300 to limit radial movement
of the flange seal 450 (FIG. 12). More particularly, as shown in
FIGS. 8, 10 and 11, the radial travel limiting contact surface is a
plug sealing cylindrical surface 412 extending from proximate to
the internal flange 410 away from the cavity 402 that is configured
to form a plug seal with a closure device 200a, 200b, 200c,
300.
[0064] The container 400 illustrated in FIGS. 8, 10 and 11 further
includes an external flange 414 including a raised portion 416
positioned at an end of the neck 406 away from the cavity 402. The
external flange 414 is configured to contact the closure device
200a, 200b, 200c, 300 to form an external flange seal 454 (FIG.
12). As best seen in FIG. 12, the plug seal 452 is positioned
between the internal flange seal 450 formed by the internal flange
410 and the external flange seal 454. As such, the internal flange
seal 450 is positioned between the plug seal 452 and the cavity
402.
[0065] As also shown in the embodiments of the container 400 in
FIGS. 8, 10 and 11, the container 400 is configured to mate with a
closure member retaining a closure device 200a, 200b, 200c, 300 in
the opening 404. In particular, the neck 406 includes a narrowed
portion 430 and an intermediate portion 432 extending from the
narrowed portion 430 to the longitudinally extending member 420
defining the plug sealing cylindrical surface 412. A closure member
may, thus, be crimped or the like around the neck portion 406 to
engage an intermediate portion 432 to retain the closure device
200a, 200b, 200c, 300 in the opening 404 and to apply longitudinal
forces for forming respective flange seals 450, 454. The narrowed
portion 430 is further shown as having an internal surface 418
configured to engage the tabs 214, 314 to hold a closure device
200a, 200b, 200c, 300 in the degassing position as seen in FIGS.
13A and 14A, respectively.
[0066] A standard vial 140 generally contains straight sides 144 in
the neck of the bottle as shown in FIG. 9B. As shown in FIG. 9A, a
neck 356 of a container 350 includes an internal step 360. An
opening 354 extends through the neck 356 to a cavity 352 defined by
a main body 358 of the container 350. Further, there are three
surfaces 360, 362, 364/366 for sealing with a stopper of the
present invention, such as the closure device of FIGS. 6A-6F. Only
two of these, the lower flange surface 360 and the plug surface
362, may be used when a stopper, such as the closure device of
FIGS. 7A-7D is used. FIGS. 9A and 9B differ in that the neck of the
container 350 shown in FIG. 9A has a flange seal between the vial
contents and the plug seal, whereas the neck of standard vial 140
as shown in FIG. 9B does not have such a flange seal, although the
sides 144 may provide a plug seal and an external flange seal may
be provided by the surface 142.
[0067] FIG. 12 shows the placement of the closure device 200a of
FIG. 6A in the container (vial) of FIG. 8, including a main body
408 defining a cavity 402 for receiving a specimen. There are three
sealing surfaces in the vial as compared to two in a standard vial.
The vial has an internal flange which mates with the stopper flange
to form an internal flange seal 450. An external flange seal 454 is
also shown with a plug seal 452 between the flange seals 450, 454.
The crimp seal or closure is not shown for clarity.
[0068] As can be seen in FIG. 12, an edge of the internal flange
seal 450 may be placed in direct contact with the product
(specimen) contents. On top of the internal flange seal 450 is the
plug seal 452. This is the reverse of most standard stoppers, in
which a plug seal is in direct contact with the product contents
and a flange seal is behind this plug seal.
[0069] In the stopper shown in FIG. 12, the internal flange seal
450 is in direct contact with the product contents, which may allow
for moist heat to penetrate the product contact surfaces. The
flange seal 450 between the stopper and specimen container or vial
may be a more controlled surface and may be less variable in
contact than a plug seal. The stopper compression at this flange
seal may be set by the closure force, which is in contrast to a
plug seal that relies on the geometric interference to maintain
compression. By also incorporating a plug seal, the seal integrity
of the product may be more robust than if the flange seal were used
alone.
[0070] In some embodiments of the present invention, the plug seal
is isolated from the vial contents. This may result in a higher
rate of lethality of microorganisms during a terminal sterilization
process.
[0071] The degassing process using the closure devices of FIGS.
6A-6G and 7A-7D will now be further described with reference to
FIGS. 13A-13B and 14A-14B, respectively. The illustrated closure
devices (stoppers) 200a, 300 include four tabs (nibs) 214, 314 at
the end of the stopper 200a, 300, although fewer or more nibs can
be used. These nibs 214, 314 have a geometrical interference with
the neck 406 of a bottle. Further, these nibs 214, 314 are
compressed into the inner neck 418 of a bottle and hold the stopper
200a, 300 above the surface of the bottle. Gases can be evacuated
or added to the bottle through a passage 460, 460' defined by the
annulus between the stopper and the inner neck of the bottle, up
between the stopper nibs 214, 314. After the degassing process is
complete, the stopper 200a, 300 may be pressed into the bottle and
the sealing surfaces of the stopper seals the contents as seen in
FIGS. 13B and 14B, respectively.
[0072] FIG. 15 is a perspective view illustrating a closure device
(stopper) 500 according to yet further embodiments of the present
invention. The stopper 500 of FIG. 15 does not have a large plug
seal. The illustrated stopper 500 includes a cap part 507 defining
a flange seal surface 506 and an extension part 512. The extension
part 512 includes 6 tabs (nibs) 508 defining a radial travel
limiter. However, more or less tabs 508 may be provided.
Furthermore, it will be understood that the cap part 507 may define
a plug seal exterior circumferential surface that forms a plug seal
with a mating surface of a receiving container, where a flange seal
formed by the flange seal surface 506 will be positioned between
the contents of the container and the plug seal.
[0073] A specimen enclosure apparatus 600 according to further
embodiments of the present invention will now be described with
reference to FIGS. 16A through 16C. FIG. 16A is a cross-sectional
view illustrating a degassing position while FIG. 16C is a
cross-sectional view illustrating a closed or sealed position. FIG.
16B is a perspective view illustrating the closed position of FIG.
16C. As seen in the embodiments of FIGS. 16A through 16C, a
container 408' has a cavity 402' configured to receive the
specimen. An opening 404' extends through a neck 406' of the
container 408' to the cavity 402'. A closure device 601 covers the
opening 404'. The closure device 601 has a flange seal portion 606
that is configured to contact an external flange seal portion 414'
on an end of the neck 406' of the container 408' displaced from the
cavity 402' to form a flange seal 450' (FIG. 16C). The flange seal
450' closes the opening 404'. The closure device further includes a
radial travel limiter 608 integrally formed with the closure device
601 that contacts an exterior surface 420' of the neck 406' to
limit radial movement of the flange seal portion 606 of the closure
device 601 relative to the external flange seal portion 414' of the
container 408'.
[0074] As seen in FIGS. 16B, a closure member 407, 407', 407'' is
coupled to the container 408' that retains the closure device 601
covering the opening 404' and compresses the flange seal 450'. The
closure member 407, 407', 407'' may be a crimp seal, a screw cap, a
tear-off seal and/or the like with a septum liner. The closure
member 407, 407', 407'' may be metal and/or plastic. As seen best
in FIG. 16C, an edge 620 of the flange seal 450' adjacent the
opening 404' is positioned to be directly exposed to moist heat
during sterilization.
[0075] The illustrated closure device 601 of FIGS. 16A through 16C
further includes a degassing extension member 612 extending from
the flange seal portion 606 along an exterior surface of the neck
406' that is configured to retain the closure device 601 in
degassing position (FIG. 16A) defining a passage from the cavity
402' through the opening 404' through which a gas may be moved into
and out of the cavity 402'. As more particularly shown in the
embodiments of FIGS. 16A through 16C, the degassing extension
member 612 includes a tab 614 extending from a surface thereof
configured to engage the exterior surface 420'of the neck 406' to
retain the closure device 601 in the degassing position shown in
FIG. 16A. More particularly, the illustrated tab 614 is a
circumferentially extending ridge 614 and the degassing extension
member 612 further includes a plurality of slots 615 extending past
the ridge 614 to define the passage along the exterior surface of
the neck.
[0076] As also shown in the embodiments of FIGS. 16A through 16C,
the neck 406' includes a plug sealing cylindrical surface defined
by the exterior surface 420' of the neck 406'. The radial travel
limiter is formed by a mating plug sealing cylindrical surface 608
of the closure device 601 that is configured to form a radial seal
652 (FIG. 16C) with a plug sealing cylindrical surface 420' of the
neck 406'. The flange seal 450' is positioned between the radial
seal 652 and the cavity 402' as seen in FIG. 16C. As such, the
closure member 407, 407', 407'' may serve to compress both the
flange seal 450' and the radial seal 652. Note that references to a
radial seal herein refer to the radial direction in which the seal
forming forces are imparted by the closure member 407, 407', 407''.
In contrast, a plug seal, as discussed above, is formed by
geometric interference of the fit of the closure device into an
opening in the neck of the container. Thus, in the embodiments of
FIGS. 16A through 16C, a flange seal is positioned with an edge in
direct contact to the cavity so as to be exposed to moist heat,
while the radial seal is positioned outside the container 408'
forming a seal with an exterior surface thereof with a flange seal
450' positioned between the radial seal 652 and the specimen
contents of the cavity 402'.
[0077] Some embodiments of the present invention can be used in
products other than those which require terminal sterilization,
such as lyophilized products including pharmaceuticals. The process
of degassing described above with various stoppers of the present
invention is similar to that in a lyophilization process.
Lyophilized products generally require that ambient moisture does
not penetrate into the vial and cause melt-back of the lyophilized
product. Some embodiments of the present invention provide stoppers
having three sealing surfaces that may have a high level of seal
integrity. Secondly, injectable pharmaceutical products generally
must be sterile as the contents are injected into a patient. The
flange seal in proximity to the sample contents may prevent
specimens, such as microorganisms, on the plug seal surface from
entering the vial contents. The flat surface of the stopper in some
embodiments can typically be easily sterilized with UV or other
sterilization, whereas the cylindrical plug surface may be more
difficult.
[0078] Example stoppers such as illustrated in FIGS. 6A and 7A and
a vial as illustrate in FIG. 8 may be made from stereolithography
models and cast into polyurethane models. The final polyurethane
models may have 50 Shore A hardness that is a typical durometer of
elastomer stoppers. A prototype model of the vial may be made by
stereolithography and may be tested with the stopper prototypes for
fit.
[0079] The foregoing is illustrative of the present invention and
is not to be construed as limiting thereof. Although a few
exemplary embodiments of this invention have been described, those
skilled in the art will readily appreciate that many modifications
are possible in the exemplary embodiments without materially
departing from the novel teachings and advantages of this
invention. Accordingly, all such modifications are intended to be
included within the scope of this invention as defined in the
claims. In the claims, means-plus-function clauses are intended to
cover the structures described herein as performing the recited
function and not only structural equivalents but also equivalent
structures. Therefore, it is to be understood that the foregoing is
illustrative of the present invention and is not to be construed as
limited to the specific embodiments disclosed, and that
modifications to the disclosed embodiments, as well as other
embodiments, are intended to be included within the scope of the
appended claims. The invention is defined by the following claims,
with equivalents of the claims to be included therein.
* * * * *