U.S. patent application number 13/917562 was filed with the patent office on 2013-12-19 for device with penetrable septum, filling needle and penetrable closure, and related method.
The applicant listed for this patent is Daniel Py. Invention is credited to Daniel Py.
Application Number | 20130333796 13/917562 |
Document ID | / |
Family ID | 49754808 |
Filed Date | 2013-12-19 |
United States Patent
Application |
20130333796 |
Kind Code |
A1 |
Py; Daniel |
December 19, 2013 |
DEVICE WITH PENETRABLE SEPTUM, FILLING NEEDLE AND PENETRABLE
CLOSURE, AND RELATED METHOD
Abstract
A device has a sealed chamber; a first penetrable septum in
fluid communication with the chamber that is formed of an elastic
material and is penetrable by a first injection member to fill the
first chamber with a substance therethrough; and a second
penetrable septum movable between first and second positions. In
the first position, at least a portion of the second septum is
spaced away from the first septum to allow the injection member to
penetrate the first septum and aseptically or sterile fill the
chamber with a substance therethrough. In the second position, the
portion of the second septum overlies and seals a resulting
injection aperture in the first septum after withdrawal of the
first injection member therefrom, and is penetrable by a second
injection member to penetrate the first and second septums and
withdraw a filled substance from the chamber and through the second
injection member.
Inventors: |
Py; Daniel; (Larchmont,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Py; Daniel |
Larchmont |
NY |
US |
|
|
Family ID: |
49754808 |
Appl. No.: |
13/917562 |
Filed: |
June 13, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61659382 |
Jun 13, 2012 |
|
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|
61799744 |
Mar 15, 2013 |
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Current U.S.
Class: |
141/1 ;
141/329 |
Current CPC
Class: |
B65D 51/002 20130101;
A61J 1/05 20130101; B65D 2251/0015 20130101; A61J 1/1406 20130101;
B65B 3/003 20130101; B65D 2251/009 20130101; A61J 1/1425
20150501 |
Class at
Publication: |
141/1 ;
141/329 |
International
Class: |
B65D 51/00 20060101
B65D051/00 |
Claims
1. A device comprising: a sealed chamber; a first penetrable septum
in fluid communication with the chamber, wherein the first septum
is penetrable by a first needle or like injection member to fill
the chamber with a substance therethrough; and a second penetrable
septum, movable between (i) a first position, wherein at least a
portion of the second penetrable septum is spaced away from the
first penetrable septum to allow the first needle or like injection
member to penetrate the first penetrable septum, without
penetrating the second penetrable septum, and, in turn, fill the
chamber with substance, and (ii) a second position, wherein said at
least a portion of the second penetrable septum overlies and seals
a resulting injection aperture in the first penetrable septum after
withdrawal of the first needle or like injection member therefrom;
wherein the second penetrable septum is penetrable in the second
position by a second needle or like injection member to, in turn,
penetrate the underlying first penetrable septum and withdraw
substance from the chamber.
2. A device as defined in claim 1, further comprising a body
defining the chamber and a first closure connected to the body and
forming a fluid-tight seal therebetween, wherein the first closure
includes the first penetrable septum.
3. A device as defined in claim 2, further comprising a second
closure connectable to at least one of the first closure and body,
wherein the second closure includes the second penetrable
septum.
4. A device as defined in claim 3, wherein at least one of the
first and second penetrable septums is at least one of (i)
co-molded and (ii) over-molded with the first closure and second
closure, respectively.
5. A device as defined in claim 4, wherein the first penetrable
septum is co-molded or over-molded with the first closure, and the
second penetrable septum is co-molded or over-molded with the
second penetrable septum.
6. A device as defined in claim 3, wherein the second closure is
connected to the first closure, and at least one of the first and
second closures is movable relative to the other to position the
second closure in the first or second position.
7. A device as defined in claim 6, further comprising a hinge
coupled between the first and second closures to allow movement of
the second closure from the first position to the second
position.
8. A device as defined in claim 7, wherein the hinge is a living
hinge.
9. A device as defined in claim 7, wherein the first and second
closures are injection molded as one part, and the first and second
penetrable septums are over-molded to the first and second
closures, respectively.
10. A device as defined in claim 1, wherein the first penetrable
septum is sufficiently resilient to close upon itself after
withdrawal of a needle or like injection member to thereby maintain
the chamber in a sealed condition prior to sealing the resulting
injection aperture with the second penetrable septum.
11. A device as defined in claim 1, wherein at least one of the
first penetrable septum and the second penetrable septum is
approximately dome or convex shaped.
12. A device as defined in claim 11, wherein the at least one of
the first penetrable septum and the second penetrable septum is
approximately dome or convex shaped on a side thereof substantially
opposite the side of the chamber.
13. A device as defined in claim 1, wherein the first penetrable
septum comprises a substantially homogeneous material.
14. A device as defined in claim 10, wherein the first penetrable
septum comprises silicone.
15. A device as defined in claim 1, wherein the first penetrable
septum defines a durometer within the range of about 20 Shore A to
about 50 Shore A.
16. A device as defined in claim 15, wherein the first penetrable
septum defines a durometer within the range of about 25 Shore A to
about 45 Shore A.
17. A device as defined in claim 1, wherein the first penetrable
septum defines a thickness within the range of about 1/2 to about
two times a largest diameter of the filling member member.
18. A device as defined in claim 1, wherein the first penetrable
septum is configured such that penetration of the first penetrable
septum by the first needle or like injection member achieves at
least approximately a 3 log reduction in bio-burden on a tip of the
first needle or like injection member.
19. A device as defined in claim 18, wherein the first penetrable
septum is configured such that penetration of the first penetrable
septum by the first needle or like injection member achieves at
least approximately a 6 log reduction in bio-burden of the tip of
the first needle or like injection member.
20. A device as defined in claim 3, wherein the first closure
includes a first connecting member, the second closure includes a
second connecting member, at least one of the first and second
connecting members is engageable with the other to secure the
second penetrable septum in the second position.
21. A device as defined in claim 20, wherein at least one of the
first and second connecting members is receivable within the other
to secure the second penetrable septum in the second position.
22. A device as defined in claim 21, wherein the first connecting
member defines a recess, and the second connector member defines a
protrusion receivable within the recess to secure the secure the
second penetrable septum in the second position.
23. A device as defined in claim 22, wherein the protrusion defines
a chamfer or beveled surface slideable against the recess to insert
the second connecting member into the first connector member, and
wherein the protrusion is engageable with an underside of the
recess to secure the second connecting member to the first
connecting member.
24. A device as defined in claim 23, wherein the recess extends
annularly about the first connecting member, and the protrusion
extends annularly about the second connecting member.
25. A device as defined in claim 1, wherein the sealed chamber is
empty and at least one of aseptic and sterile.
26. A device as defined in claim 1, wherein the sealed chamber is
at least partially filled with a substance that is at least one of
sterile and aseptic.
27. A device as defined in claim 2, wherein the body comprises
plastic or glass.
28. A device as defined in claim 1, wherein the entirety of the
second penetrable septum is spaced away from the first penetrable
septum in the first position.
29. A device as defined in claim 1, further comprising a body
defining the chamber and a closure overlying the first penetrable
septum and connected to the body and forming a fluid-tight seal
therebetween, and wherein the second penetrable septum is slidably
received in the closure.
30. A device as defined in claim 29, further comprising a disk
including the second penetrable septum, and wherein the closure
further defines a lateral slot therein for slidably receiving the
disk therein, and wherein the disk creates a dimensional
interference fit with the slot, thereby creating a sliding,
fluid-tight seal, therebetween.
31. A device as defined in claim 29, further comprising a disk
including the second penetrable septum, wherein the second
penetrable septum is positioned substantially off-center within the
disk.
32. A device as defined in claim 1, wherein the second septum
comprises a first portion and a second portion, wherein said second
portion defines said at least a portion of the second septum, and
in the first position, the first portion of the second septum
sealingly overlies the first septum and the second portion of the
second septum is spaced away from the first septum, and in the
second position, the second portion of the second septum sealingly
overlies the first septum and the first portion of the second
septum is spaced away from the first septum.
33. A device comprising: a sealed chamber; first means for filling
the first chamber with a substance therethrough, in fluid
communication with the chamber, and penetrable by a first needle or
like injection member, and second means for sealing the first
means, movable between (i) a first position, wherein at least a
portion of the second means is spaced away from the first means for
allowing the first needle or like injection member to penetrate the
first means without penetrating the second means and fill the
chamber therethrough, and (ii) a second position for sealing a
resulting injection aperture in the first means after withdrawal of
the first needle or like injection member therefrom, and penetrable
by a second needle or like injection member for penetrating the
first and second means and withdrawing a filled substance from the
chamber and through the second needle or like injection member.
34. A device as defined in claim 33, wherein the first means
includes a first penetrable septum, and the second means includes a
second penetrable septum.
35. A device comprising: a sealed chamber, and a penetrable septum
having a first penetrable portion and a second penetrable portion,
wherein the penetrable septum is movable between (i) a first
position where the first penetrable portion is in fluid
communication with the chamber to allow a first needle or like
injection member to penetrate therethrough, and, in turn, fill the
chamber with substance, and (ii) a second position where the first
penetrable portion is not in fluid communication with the chamber,
and the second penetrable portion seals the chamber from the
ambient environment and is in fluid communication with the chamber
to allow a second needle or like injection member to penetrate
therethrough, and, in turn, withdraw substance from the
chamber.
36. A device as defined in claim 35, further comprising a body
defining the chamber and a closure connected to the body and
forming a fluid-tight seal therebetween, wherein the penetrable
septum is slidably received in the closure.
37. A device as defined in claim 36, further comprising a disk
including the penetrable septum, and wherein the closure further
defines a lateral slot therein for slidably receiving the disk
therein, and wherein the disk creates a dimensional interference
fit with the slot, thereby creating a sliding, fluid-tight seal,
therebetween.
38. A filling device comprising: a hollow filling member, a
penetrating tip formed at one end of the filling member, at least
one port in fluid communication between an interior of the hollow
filling member and an exterior of the hollow filling member, and a
closure, wherein at least one of the closure and filling member is
movable between (i) a first position wherein the closure closes the
at least one port and forms a fluid-tight seal between the at least
one port and ambient atmosphere to maintain sterility of the at
least one port and an interior of the filling member, and (ii) a
second position opening the at least one port to allow substance to
pass between said interior and said exterior.
39. A filling device as defined in claim 38, wherein the closure is
biased in a direction from the second position toward the first
position to normally close the at least one port.
40. A filling device as defined in claim 39, further including a
biasing member biasing the closure in the direction from the second
position toward the first position.
41. A filling device as defined in claim 38, wherein the closure is
configured such that, upon engagement of the closure with a
penetrable septum or a portion of a device including a penetrable
septum and penetration thereof by the filling member, the at least
one of the closure and filling member moves from the first position
toward the second position.
42. A filling device as defined in claim 38, wherein the closure is
configured such that, during withdrawal of the filling device from
the septum, the at least one of the closure and the filling member
moves from the second position toward the first position.
43. A filling device as defined in claim 38, wherein the closure
extends annularly about the filling member.
44. A filling device as defined in claim 38, wherein the tip of the
filling member defines a stop surface, and an end of the closure
adjacent the tip is engageable with said stop surface in the first
position, thereby stopping the closure and forming a fluid-tight
seal therebetween.
45. A filling device as defined in claim 44, further comprising a
sealing member located between the end of the closure and the stop
surface forming a substantially fluid-tight seal therebetween when
the closure is engaged with the stop surface in the first
position.
46. A filling device as defined in claim 45, wherein the sealing
member is molded to one of (i) the end of the closure and (ii) the
stop surface.
47. A filling device as defined in claim 38, further comprising a
flexible shell extending annularly about, and sealingly enclosing,
a portion of the filling member.
48. A filling device as defined in claim 47, wherein the flexible
shell comprises a bellows.
49. A filling device as defined in claim 47, wherein the flexible
shell defines a valve configured to vent air from within the shell
to the ambient atmosphere when the at least one of the closure and
the filling member is moved from the first position toward the
second position.
50. A filling device comprising: first means for the passage of
fluid therethrough; second means for penetrating a septum formed at
one end of the first means, third means formed on the first means
for the passage of fluid between an interior of the first means and
an exterior thereof; and fourth means movable between (i) a first
position for closing the third means and forming a substantially
fluid-tight seal between the third means and ambient atmosphere,
and (ii) a second position for opening the third means for
permitting the passage of substance between said interior and said
exterior of the first means.
51. A filling device as defined in claim 50, wherein the first
means comprises a filling member, the second means comprises a
penetrating tip of the filling member, the third means comprises at
least one port, and the fourth means comprises a closure.
52. A method comprising the following steps: penetrating a first
penetrable septum with a first needle or like injection member and
placing the first needle or like injection member into fluid
communication with a sealed, empty chamber; introducing a substance
through the first needle or like injection member and into the
chamber; withdrawing the first needle or like injection member from
the first penetrable septum; and sealing a resulting penetration
aperture in the first penetrable septum with at least a region of a
second penetrable septum.
53. A method as defined in claim 52, wherein the sealing step
includes moving the second penetrable septum from a first position
where a first portion thereof overlies the first penetrable septum,
to a second position where the at least a region of the second
septum overlies and sealingly engages the first penetrable
septum.
54. A method as defined in claim 52, wherein the sealing step
includes moving the second penetrable septum from a first position
spaced away from the first penetrable septum to a second position
overlying and sealingly engaging the first penetrable septum.
55. A method as defined in claim 54, wherein a first closure
includes the first penetrable septum and a second closure includes
the second penetrable septum, and in the second position, the
second closure is fixedly secured to the first closure.
56. A method as defined in claim 52, wherein the sealing step
includes overlying the first penetrable septum with said at least a
region of the second penetrable septum, and further comprising
penetrating the second penetrable septum and the first penetrable
septum with a second needle or like injection member and into fluid
communication with the substance in the chamber and withdrawing
substance from the chamber through the second needle or like
injection member.
57. A method as defined in claim 52, further comprising the step
of, prior to the sealing step, sterilizing at least an top surface
of the first penetrable septum and a bottom surface of the second
penetrable septum.
58. A method as defined in claim 57, wherein the sterilizing step
includes applying radiation to said surfaces.
59. A method as defined in claim 52, further comprising the step of
sterilizing the sealed empty chamber prior to penetrating the first
penetrable septum.
60. A method as defined in claim 52, wherein the step of
penetrating the first penetrable septum further comprises wiping a
tip of the first needle or like injection member with the first
penetrable septum.
61. A method as defined in claim 60, wherein the first penetrable
septum defines a durometer within the range of about 20 Shore A to
about 50 Shore A.
62. A method as defined in claim 60, wherein the first penetrable
septum defines a thickness within the range of about 1/2 to about
two times a largest outer diameter of the needle or like injection
member.
63. A method as defined in claim 60, wherein the step of
penetrating the first penetrable septum comprises penetrating with
a needle or like injection member including a tip defining an
included angle within the range of about 20 degrees to about 40
degrees.
64. A method as defined in claim 60, wherein the wiping step
includes providing at least approximately a 3 log reduction in
bio-burden on the needle or like injection member.
65. A method as defined in claim 52, wherein the step of
penetrating the first penetrable septum comprises penetrating with
a first injection member comprising a hollow filling member, a
penetrating tip formed at one end of the filling member, at least
one port in fluid communication between an interior of the hollow
filling member and an exterior of the hollow filling member, and a
closure, wherein at least one of the closure and filling member is
movable between (i) a first position wherein the closure closes the
at least one port and forms a fluid-tight seal between the at least
one port and ambient atmosphere to maintain sterility of the at
least one port and an interior of the filling member, and (ii) a
second position opening the at least one port to allow substance to
pass between said interior and said exterior, and further
comprising, prior to or during the step of penetrating the first
penetrable septum, moving the at least one of the closure and
filling member from the closed position to the open position.
66. A method as defined in claim 65, further comprising the step
of, before or during the withdrawing step, moving the at least one
of the closure and filling member from the open position to the
closed position.
67. A method as defined in claim 65, wherein the introducing step
comprises introducing substance from the first injection member and
into the chamber after penetrating the first penetrable septum or
after part of the at least one filling port has passed through an
interior surface of the first penetrable septum and is located
within the chamber.
68. A method as defined in claim 65, further comprising, during the
penetrating and withdrawing steps, substantially preventing any
contact between the at least one filling port and the first
penetrable septum.
69. A method as defined in claim 68, wherein the substantially
preventing step includes maintaining the closure in the first
position, and thus between the at least one filling port and first
penetrable septum.
70. A method as defined in claim 52, wherein the first penetrable
septum sufficiently resilient to close upon itself after withdrawal
of the needle or like injection member to thereby maintain the
chamber in a sealed condition prior to sealing the resulting
injection aperture with the second penetrable septum.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims benefit under 35 U.S.C.
.sctn.119 to similarly-titled U.S. Provisional Patent Application
Nos. 61/659,382, filed Jun. 13, 2012, and 61/799,744, filed Mar.
15, 2013, both of which are hereby incorporated by reference in
their entirety as part of the present disclosure.
FIELD OF THE INVENTION
[0002] The present invention relates to a device, such as a
container, vial or dispenser, with a septum that is penetrable for
filling a chamber with a substance therethrough, a closure that
closes the penetrated septum and is itself penetrable for accessing
the substance filled into the chamber, and a filling device for
filling the chamber through the septum, and related methods.
BACKGROUND INFORMATION
[0003] A typical previously-known vial having a penetrable septum
for filling therethrough leaves a residual injection aperture in
the septum after a filling needle penetrates and withdraws
therefrom. Hermetically resealing the penetrated septum requires
utilizing an external source such as radiation or chemicals. While
such methods are effective, one drawback is that radiation or
chemical resealing requires relatively expensive parts in a filling
assembly line.
[0004] A typical previously-known filling needle includes a hollow
stainless steel shaft, a non-coring, conically-pointed tip fixedly
secured to the distal end of the shaft, and diametrically opposed
fluid ports proximal to the tip and in fluid communication between
the interior of the shaft and the ambient environment. One drawback
encountered with previously-known filling needles is that the
interior of the needle, and any fluid contained therein or passing
therethrough, can be exposed to the ambient environment via the
open fluid ports. In connection with known filling machines,
regulatory agencies require control of the filling needle
environment in order to protect against exposure of a sterile
product to the environment and the resulting contamination of the
product that might occur. However, typical controlled environments,
such as a class 100 (ISO-5) controlled environment, are not truly
sterile. Although the likelihood of contamination in such
reduced-contaminant environments may be relatively low, just one
colony of contaminants can develop into a container full of germs
over its shelf-life. This risk is exacerbated when filling
traditional open containers that are thereafter sealed in an
assembly machine. No such previously-known assembly machine, such
as, for example, a typical machine closing 40,000 containers per
hour, can fully prevent entrance of viables and non-viables into
the containers. Another drawback of the needle opening is the
build-up of product around the opening, or even dripping.
SUMMARY OF THE INVENTION
[0005] It is an object of the present invention to overcome one or
more of the above-described drawbacks and/or disadvantages of the
prior art.
[0006] In accordance with a first aspect, a device comprises a
sealed chamber; a first penetrable septum in fluid communication
with the chamber that is penetrable by a first needle or like
injection member to fill the first chamber with a substance
therethrough; and a second penetrable septum. The second penetrable
septum is movable between first and second positions. In the first
position, at least a portion of the second septum is spaced away
from the first septum to allow the needle or like injection member
to penetrate the first septum and aseptically or sterile fill the
chamber with a substance therethrough. In the second position, said
at least a portion of the second septum overlies and mechanically
seals a resulting injection aperture in the first septum after
withdrawal of the first needle or like injection member therefrom,
and is penetrable by a second needle to penetrate the first and
second septums and withdraw a filled substance from the
chamber.
[0007] In some embodiments, the device further comprises a body
defining the chamber and a first closure connected to the body and
forming a fluid-tight seal therebetween. The first closure includes
the first penetrable septum. In some such embodiments, the device
further comprises a second closure connectable to the first closure
and/or body. The second closure includes the second penetrable
septum. In some such embodiments, the first and/or second
penetrable septums are co-molded with the first and second
closures, respectively. In other embodiments, the first penetrable
septum is over-molded onto the first closure, and the second
penetrable septum is over-molded onto the second closure. In some
such embodiments, the first and/or second penetrable septums are
over-molded to the first and second closures, respectively, at the
same time.
[0008] In some embodiments, the second closure is connected to the
first closure, and at least one of the first and second closures is
movable relative to the other to position the second closure in the
first or second positions. In some such embodiments, the device
further comprises a hinge coupled between the first and second
closures to allow movement of the second closure from the first
open position to the second closed position. In some such
embodiments, the hinge is a living hinge. In some such embodiments,
the first and second closures are injection molded as one part, and
the first and second penetrable septums are over-molded to the
first and second closures, respectively.
[0009] In some embodiments, the first penetrable septum is formed
of an elastic material. In some such embodiments, the aperture
formed in the first penetrable septum by the needle, injection or
filling member substantially closes upon withdrawal of the needle,
injection or filling member due to the elastic properties of the
material. In yet further of such embodiments, the material is
sufficiently elastic to substantially hermetically seal itself at a
resulting penetration aperture after withdrawal of the first needle
or like injection member therefrom. In some such embodiments, the
first septum is approximately dome or convex shaped. In some such
embodiments, the first septum is approximately dome or convex
shaped on a side thereof substantially opposite the side of the
chamber.
[0010] In some embodiments, the second penetrable septum is
approximately dome or convex shaped. In some such embodiments, the
second septum is approximately dome or convex shaped on a side
thereof substantially opposite or juxtaposed with respect to the
upper side of the first septum in a way that the second septum and
first septum provide a mechanical seal around an aperture left by a
filling needle.
[0011] In some embodiments, the first septum comprises a
substantially homogeneous material, such as, for example, silicone.
In some embodiments, the first septum defines a durometer within
the range of about 5 Shore A to about 65 Shore A, such as within
the range of about 25 Shore A to about 45 Shore A. In some
embodiments, the first septum defines a thickness within the range
about 1/2 to about twice the largest diameter of the needle or like
injection member that penetrates the first septum to fill a chamber
therethrough.
[0012] In some embodiments, penetration of the first septum by the
first needle or like injection member achieves at least about a 3
log reduction in bio-burden by wiping the tip of the first needle
or like injection member. In some such embodiments, penetration of
the first septum by the first needle or like injection member
achieves at least about a 6 log reduction in bio-burden of the
tip.
[0013] In some embodiments, the first closure includes a first
connecting member, the second closure includes a second connecting
member, and at least one of the first and second connecting members
is engageable with the other to secure the second penetrable septum
in the second position. In some such embodiments, at least one of
the first and second connecting members is receivable within the
other to secure the second penetrable septum in the second
position. In some such embodiments, the first connecting member
defines a recess, and the second connector member defines a
protrusion receivable within the recess to secure the second
penetrable septum in the second position. In some such embodiments,
the protrusion defines a chamfer or beveled surface slideable
against the recess to facilitate inserting the second connecting
member into the first connector member. The protrusion is
engageable with an underside of the recess to secure the second
connecting member to the first connecting member. In some such
embodiments, the recess extends angularly about the first
connecting member, and the protrusion extends angularly about the
second connecting member.
[0014] In some embodiments, the second penetrable septum is
entirely spaced away from the first penetrable septum in the first
position.
[0015] In some embodiments, the device further comprises a body
defining the chamber and a closure overlying the first penetrable
septum and connected to the body and forming a fluid-tight seal
therebetween. The second penetrable septum is slidably received in
the closure. In some such embodiments, the device further comprises
a disk including the second penetrable septum. In some such
embodiments, the closure further defines a lateral slot therein for
slidably receiving the disk therein, wherein the disk creates a
dimensional interference fit with the slot, thereby creating a
sliding, fluid-tight seal, therebetween.
[0016] In some embodiments, the second septum comprises a first
portion and a second portion, wherein said second portion defines
said at least a portion of the second septum. In the first
position, the first portion of the second septum sealingly overlies
the first septum and the second portion of the second septum is
spaced away from the first septum. In the second position, the
second portion of the second septum sealingly overlies the first
septum and the first portion of the second septum is spaced away
from the first septum.
[0017] In accordance with another aspect, a device comprises a
sealed chamber; first means in fluid communication with the chamber
and penetrable by a first needle or like injection member for
filling the first chamber with a substance therethrough; and second
means movable between a first position, wherein at least a portion
of the second means is spaced away from the first means for
allowing the first needle or like injection member to penetrate the
first means and fill the chamber therethrough, and a second
position for sealing a resulting injection aperture in the first
means after withdrawal of the first needle or like injection member
therefrom, and penetrable by a second needle or like injection
member for penetrating the first and second means and withdrawing a
filled substance from the chamber and through the second needle or
like injection member.
[0018] In some embodiments, the first means is formed of an elastic
material. In some embodiments, the first means is a first
penetrable septum, and the second means is a second penetrable
septum.
[0019] In accordance with another aspect, a device comprises a
sealed chamber, and a penetrable septum, having a first portion and
a second portion, in fluid communication with the chamber. The
penetrable septum is movable between (i) a first position, wherein
the first portion is in fluid communication with the chamber to
allow a first needle or like injection member to penetrate
therethrough, and, in turn, fill the chamber with substance, and
(ii) a second position, wherein the second, unpenetrated portion,
sealingly overlies the chamber after withdrawal of the first needle
or like injection member therefrom. The second portion is
penetrable in the second position by a second needle or like
injection member to, in turn, withdraw substance from the
chamber.
[0020] In some embodiments, the device further comprises a body
defining the chamber and a closure connected to the body and
forming a fluid-tight seal therebetween, wherein the penetrable
septum is slidably received in the closure. In some such
embodiments, the device further comprises a disk including the
penetrable septum. In some such embodiments, the closure further
defines a lateral slot therein for slidably receiving the disk
therein, wherein the disk creates a dimensional interference fit
with the slot, thereby creating a sliding, fluid-tight seal,
therebetween.
[0021] In accordance with another aspect, a filling device
comprises a hollow filling member. A tip is formed at one end of
the filling member, at least one port is in fluid communication
with the interior of the hollow filling member, and an annular
shell extends radially and angularly about the filling member. A
closure is coupled to the annular shell, and at least one of the
closure and the filling member is movable between (i) a first
position wherein the closure closes the at least one port and forms
a substantially fluid-tight seal between the fluid port and ambient
atmosphere to facilitate maintaining sterility of the port and
interior of the filling member, and (ii) a second position opening
the at least one port and allowing a flow of substance through the
port.
[0022] In some embodiments, the closure is biased in a direction
from the second position toward the first position to normally
close the at least one port. In some such embodiments, the filling
device further comprises a biasing member biasing the closure in
the direction from the second position toward the first
position.
[0023] In some embodiments, the closure is engageable with a
penetrable septum to move at least one of the closure and filling
member from the first position to the second position upon
penetrating the septum with tip of the filling member. In some
embodiments, at least one of the closure and filling member is
movable from the second position to the first position during or
upon withdrawing the filling member from the septum.
[0024] In some embodiments, a distal end of the closure is
engageable with a stop surface of the filling member to stop the
closure in the first position and form a substantially fluid-tight
seal between the closure and filling member. In some such
embodiments, the filling device further comprises a sealing member
located between the distal end of the closure and the stop surface
and forming a substantially fluid-tight seal therebetween in the
first position. In some such embodiments, the sealing member is
integrally molded, such as by over molding, to the closure. In
other embodiments, the sealing member is integrally molded, such as
by over molding, to the stop surface.
[0025] In some embodiments, the filling member is formed of
plastic, such as any of numerous different thermoplastics,
including the liquid crystal polymers (LCP) that are highly
crystalline, thermotropic (melt-orienting) thermoplastics and sold
under the trademark VECTRA.TM. by Celanese Corporation.
[0026] In some embodiments, the annular shell forms a bellows. In
some such embodiments, the annular shell includes a one-way valve
in fluid communication between the hollow filling member and
ambient atmosphere. In some such embodiments, the one-way valve
vents out air and/or other gases from within the shell to the
ambient atmosphere when the bellows is under compression.
[0027] In accordance with another aspect, a filling device
comprises first means for providing a conduit for the passage of
fluid therethrough; second means formed at one end of the first
means for penetrating a septum; third means in fluid communication
with the conduit for passage of fluid from the conduit
therethrough; and fourth means for closing the third means. At
least one of the fourth means and the first means is movable
between (i) a first position wherein the fourth means closes the
third means and forms a substantially fluid-tight seal between the
third means and ambient atmosphere to facilitate maintaining
sterility of the third means and an interior of the first means,
and (ii) a second position opening the third means. Some
embodiments further comprise fifth means for forming a seal between
the fourth means and at least one of the first and second
means.
[0028] In some embodiments, the first means comprises a filling
member, the second means comprises a tip of the filling member, the
third means comprises at least one port, the fourth means comprises
a closure, and the fifth means comprises a sealing member.
[0029] In accordance with another aspect, a method comprises the
following steps:
[0030] (i) penetrating a first penetrable septum with a first
needle or like injection member and placing the first needle or
like injection member into fluid communication with a sealed, empty
chamber;
[0031] (ii) introducing a substance through the first needle or
like injection member and into the chamber;
[0032] (iii) withdrawing the first needle or like injection member
from the first penetrable septum; and
[0033] (iv) sealing a resulting penetration aperture in the first
needle penetrable septum with a second needle penetrable
septum.
[0034] In some embodiments, the method further comprises the steps
of:
[0035] (v) penetrating the second needle penetrable septum and the
first needle penetrable septum with a second needle or like
injection member and into fluid communication with the substance in
the chamber, and
[0036] (vi) withdrawing substance from the chamber through the
second needle or like injection member.
[0037] In some embodiments, the method further comprises, prior to
closing a resulting penetration aperture in the first septum with
the second septum, sterilizing at least an exterior surface of the
first penetrable septum defining the resulting penetration aperture
and an interior surface of the second penetrable septum, such as
with UV radiation (e.g., at a wavelength of about 254 nm), or low
energy beta radiation, or by any sterilizing agent. In some such
embodiments, the sterilizing step includes applying radiation to
said surfaces. In some such embodiments, the step of sterilizing
the sealed empty chamber is performed prior to penetrating the
first penetrable septum.
[0038] In some embodiments, the penetrating step further comprises
wiping the first needle or like injection member with the first
penetrable septum. In some such embodiments, the wiping step
comprises wiping the tip of the filling needle or like injection
member with the first penetrable septum. In some such embodiments,
the wiping step comprises wiping the needle or like injection
member with the first penetrable septum defining a durometer within
the range of about 5 Shore A to about 65 Shore A. In some other
such embodiments, the wiping step comprises wiping the needle or
like injection member with the first penetrable septum defining a
thickness within the range of about 1/2 to about two times the
largest diameter of the needle or like injection member. In other
such embodiments, the wiping step comprises wiping the tip of the
needle or like injection member, wherein the tip defines an
included bevel angle within the range of about 30 degrees to about
50 degrees, such as about 40 degrees. In some such embodiments, the
wiping step achieves at least about a 3 log reduction in bio-burden
on the tip of the needle or like injection member.
[0039] In some embodiments, the sealing step includes moving the
second penetrable septum from a first position, wherein a first
portion thereof overlies the first penetrable septum, to a second
position, wherein a second portion thereof overlies and sealingly
engages the first penetrable septum. In other embodiments, the
sealing step includes moving the second penetrable septum from a
first position spaced away from the first penetrable septum to a
second position overlying and sealingly engaging the first
penetrable septum.
[0040] In accordance with another aspect, a method comprises the
following steps: [0041] (i) penetrating a first penetrable septum
with a first needle or like injection member and placing the first
needle or like injection member into fluid communication with a
sealed, empty chamber; [0042] (ii) prior to or during the
penetrating step, moving at least one of a closure and at least one
filling port of the first needle or like injection member from a
closed position closing the at least one filling port to an open
position opening the at least one filling port; [0043] (iii)
introducing a substance through the first needle or like injection
member and into the chamber; and [0044] (iv) withdrawing the first
needle or like injection member from the first penetrable
septum.
[0045] The substance can be introduced from the first needle or
like injection member into the chamber after full perforation of
the first penetrable septum or after part of the at least one
filling port has passed through an interior surface of the first
penetrable septum and is located within the chamber. The method can
further comprise the step of substantially sealing the at least one
filling port and an interior of the needle or like injection member
from ambient atmosphere in the closed position. The method can also
comprise, before or during the withdrawing step, moving at least
one of the closure and the at least one filling port of the first
needle or like injection member from the open position to the
closed position. During the penetrating and withdrawing steps, the
method can include substantially preventing any contact between the
at least one filling port and the first penetrable septum. In some
embodiments, the closure is interposed between the at least one
filling port and first penetrable septum to substantially prevent
any contact between the at least one filling port and the first
penetrable septum.
[0046] One advantage of the present invention is that the device,
such as a container to be filled, is mechanically self-closing. As
a result, the present invention obviates the need to thermally,
chemically or laser reseal the resulting penetration aperture, and
thus obviates the need for such additional processing steps and
equipment. Another advantage is that the septum is configured to
wipe the tip of the filling needle or like injection member as it
penetrates the septum to fill the chamber, and effectively
de-contaminates and/or sterilizes the tip prior to entry into the
chamber. Accordingly, another advantage of the present invention is
that it can reduce the risk of contamination and/or reduce the
controls over, or the need to control a filling needle environment.
Another advantage is the absolute protection of the product or
substance to be filled from exposure to the environment. The needle
opens and closes automatically within the sterile or aseptic
container. The needle is always closed prior to being withdrawn
from within the sterile container. As a result, the needle is
sealed during passage through the septum to prevent any
contaminants on the septum or in the environment from contaminating
the interior of the needle.
[0047] Other objects and advantages of the present invention,
and/or of embodiments thereof, will become more readily apparent in
view of the following detailed description and the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] FIG. 1 is a side perspective view of a device in the form of
a container;
[0049] FIGS. 2A-2D sequentially show the assembly of the device of
FIG. 1, in which the septa are over-molded onto the molded cap and
the first closure is sealingly closed in place on the
container;
[0050] FIG. 3A is a partial, side cross-sectional side view of the
device of FIG. 1, with the second closure in the first, non-sealing
position;
[0051] FIG. 3B is a side cross-sectional view of the device of FIG.
1 after the filling member has pierced the device septum and has
been withdrawn leaving a hole in the device septum, with the second
closure in the first, non-sealing position, and schematically
showing sterilization of the first and second closures;
[0052] FIG. 4 is a side cross-sectional view of the device of FIG.
1, with the second closure in the second, sealing position;
[0053] FIG. 5 is a side perspective view of a filling device
engageable with the device of FIG. 1 to aseptically or sterile fill
a substance therein;
[0054] FIG. 6A is a side cross-sectional view of the filling device
of FIG. 5, with the closure in the first or closed position,
sealing the ports of the filling member from the ambient
atmosphere;
[0055] FIG. 6B is a side cross-sectional view of the filling device
of FIG. 5, with the closure in the second or open position, opening
the ports of the filling member;
[0056] FIG. 7A is a partial, side cross-sectional view of the
closure and tip of the filling device of FIG. 5 prior to engagement
with the septum of the device of FIG. 1, with the closure in the
first or closed position sealing the ports from ambient
atmosphere;
[0057] FIG. 7B is a side cross-sectional view of the filling device
of FIG. 5 upon penetration of the tip of the filling member through
a septum of the type shown in FIG. 1, with the closure still in the
first or closed position sealing the ports from contact with the
penetrated septum;
[0058] FIG. 7C is a side cross-sectional view of the filling device
of FIG. 5, where the tip of the filling member is penetrated
through the septum, the closure is prevented from further movement
through the septum, and the filling member is allowed to continue
to move into the chamber relative to the fixed closure to expose
the fluid ports to the chamber and allow the aseptic or sterile
flow of substance through the open ports and into the aseptic or
sterile chamber;
[0059] FIG. 8A is a side cross-sectional view of another embodiment
of the distal end of the filling device of FIG. 5, including a seal
over-molded to the stop surface formed at the tip of the filling
member to facilitate forming a substantially fluid-tight or
hermetic seal between the closure and filling device;
[0060] FIG. 8B is a side cross-sectional view of another embodiment
of the distal end of the filling device of FIG. 5, including a seal
over-molded to the distal end of the closure to facilitate forming
a substantially fluid-tight or hermetic seal between the closure
and filling device.
[0061] FIG. 9A is a top perspective view of a device in the form of
a container, with the second closure in the first, non-sealing
position;
[0062] FIG. 9B is a top perspective view the device of FIG. 9A with
the second closure in the first, non-sealing position with a
filling member positioned to pierce the first closure;
[0063] FIG. 9C is a side view of the device of FIG. 9A that has
been filled, with the second closure in the second, sealing
position and ready for sampling of substance in the chamber;
[0064] FIG. 9D is a side view of the filled device of FIG. 9C with
a needle piercing the second closure into the chamber to permit
withdrawal and sampling of substance from the chamber;
[0065] FIG. 9E is a side view of the device of FIG. 9C with all of
the substance withdrawn from the chamber;
[0066] FIG. 10A is a cross-sectional view of the device and filling
member shown FIG. 9B;
[0067] FIG. 10B is a cross-sectional view of the device of FIG. 9A
with the tip of the filling member penetrating the septum of the
first closure into the chamber and the closure of the filling
member in the first or closed position, sealing the ports of the
filling member from the ambient atmosphere;
[0068] FIG. 10C is a cross-sectional view of the device of FIG. 9A
with the filling member further penetrating into the chamber with
the closure of the filling member in the second or open position,
opening the ports of the filling member;
[0069] FIG. 10D is a cross-sectional view of the device of FIG. 9A
with the filling member partially withdrawn from the chamber and
the closure of the filling member moved back to the first or closed
position, re-sealing the ports of the filling member from the
ambient atmosphere;
[0070] FIG. 11 is an exploded view of another embodiment of a
device in the form of a container;
[0071] FIGS. 12A-12D show sequential side cross-sectional views of
the assembly, sterilization, filling and sealing of the device of
FIG. 11 taken along section line A-A;
[0072] FIG. 13 is a perspective cross-sectional view of another
embodiment of a device in the form of a container, prior to
assembly of the second septum thereto;
[0073] FIG. 14 is a perspective cross-sectional view of the device
of FIG. 13, with the second septum in a first, ready for filling,
position;
[0074] FIG. 15 is a perspective cross-sectional view of the device
of FIG. 13 during filling thereof;
[0075] FIG. 16 is a perspective cross-sectional view of the device
of FIG. 13, with the second septum in a second, sealing,
position;
[0076] FIG. 17 is a perspective cross-sectional view of another
embodiment of a device in the form of a container, prior to
assembly of the septum thereto;
[0077] FIG. 18 is a perspective cross-sectional view of the device
of FIG. 17, with the septum in a first, ready for filling,
position;
[0078] FIG. 19 is a perspective cross-sectional view of the device
of FIG. 17 during filling thereof;
[0079] FIG. 20 is a perspective cross-sectional view of the device
of FIG. 17 with the septum in a second, sealing, position;
[0080] FIG. 21 is an exploded view of another embodiment of a
device in the form of a container;
[0081] FIG. 22 is a perspective side view of the device of FIG. 21,
with the closure in the first position, uncovering the filling
septum; and
[0082] FIG. 23 is a perspective side view of the device of FIG. 21,
with the closure in the second position, uncovering the withdrawal
septum.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0083] In FIG. 1 a device is indicated generally by the reference
numeral 10. In the illustrated embodiment, the device 10 is a
container defining a sealed (with respect to the ambient atmosphere
or environment) empty chamber 11 therein for aseptic or sterile
filling with a substance, such as a medicament, pharmaceutical
injectable, or vaccine. However, as may be recognized by those of
ordinary skill in the pertinent art based on the teachings herein,
the invention may be embodied in and otherwise may be applicable to
any of numerous different types of devices that are currently known
or that later become known, such as vials, syringes, delivery
devices, dispensers and processing devices. Similarly, the devices
may be filled with any of numerous different substances that are
currently known or that later become known, such as medicaments,
pharmaceutical injectables, vaccines, supplements, foods,
beverages, liquid nutrition products, and industrial products, and
in any of numerous different forms, including liquids, gels,
powders and gases.
[0084] As shown in FIG. 1, the container 10 includes a body 12 and
a closure 14. In the illustrated embodiment, the body is
substantially cylindrical and defines a substantially cylindrical
sidewall 16 with an opening 18 at a top end thereof, for sealingly
receiving the closure 14 thereon, as described further below. The
body 12 further includes an annular projection 20 spaced from the
top end thereof and extending laterally outwardly from the sidewall
16. The body 12 may be made of glass or plastic. However, as may be
recognized by those of ordinary skill in the pertinent art based on
the teaching herein, the body may be made of any of numerous
different materials that are currently known or that later become
known. As also may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, the body may be
configured in any of numerous shapes to receive a closure. For
example, the body may define a spool-like or "diabolo" shape such
as disclosed in U.S. Pat. No. 7,100,646, issued Sep. 5, 2006,
entitled "Sealed Containers and Methods of Making and Filling
Same," which, in turn, claims benefit of similarly titled U.S.
Provisional Patent Application No. 60/408,086, filed Sep. 3, 2002,
each of which is hereby expressly incorporated by reference in its
entirety as part of the present disclosure.
[0085] As shown in FIGS. 2A-2D, the closure 14 comprises a first
closure 22 and a second closure 24. The first and second closures
22, 24 are angularly moveable with respect to one another. In the
illustrated embodiment, the first and second closures are coupled
via a living hinge 26. However, as may be recognized by those of
ordinary skill in the pertinent art based on the teachings herein,
the second closure may be connected to either of the first closure
or body via any of numerous connections that are currently known or
that later become known to allow movement of at least one of the
closures relative to the other. Similarly, the first and second
closures 22, 24 need not be connected in the open position, but
rather may be connected only in the closed position when the second
closure overlies and sealingly engages a penetration aperture in
the first closure. Where the first and second closures 22, 24 are
connected in the open position, they may be molded in one piece, as
shown.
[0086] Both the first and second closures 22, 24, include first and
second substantially centered recesses 28, 30 respectively, axially
extending from the top surfaces of the closures for sealingly
receiving therein first and second penetrable septums 32, 34,
respectively. The penetrable septums may be made of any material
that is penetrable by a needle, injection or filling member. The
material may be a needle-penetrable elastomeric, rubber or
rubber-like material that is sufficiently elastic to be penetrated
by a needle. In some embodiments, the septum materials also are
sufficiently elastic to substantially close a resulting penetration
aperture after removal of a needle or like injection member
therefrom. It should be noted, though, as described in the
inventor's below-referenced U.S. Pat. No. 6,604,561, that while the
aperture or hole may sufficiently close to prevent leaking or
passage of liquid through the septum, it may not close sufficiently
to prevent passage of gases, e.g. air, or other contaminants, e.g.,
microbial forms, especially over time. In some embodiments, though,
the material is sufficiently elastic to thereby hermetically reseal
itself. In embodiments where the material is under internal
compression, the compression stresses can assist in
closing/resealing the hole. In some embodiments, the first and
second penetrable septums 32, 34 are co-molded with the first and
second closure portions 22, 24, respectively. In other embodiments
the first and second penetrable septums 32, 34 are over-molded with
the first and second closure portions 22, 24, respectively, e.g.,
at the same time, as shown in FIGS. 2A and 2B. The second closure
portion 24 can then be mounted onto the body 12 as shown in FIGS.
2C and 2D. However, as may be recognized by those of ordinary skill
in the pertinent art based on the teachings herein, the penetrable
septums may be mounted within the first and second recesses in any
of numerous ways configured to sealingly mount the septums therein,
and the container may be assembled in a different order. For
example, the closure 14 may be mounted on the body 12, and then the
septums 32, 34 joined with the first and second closure portions
22, 24.
[0087] As shown in FIG. 3A, the first closure 22 includes an
annular sidewall 36 axially extending from the perimeter of the top
surface thereof, defining an axially extending annular channel 38
between the annular sidewall 36 and the annular wall of the annular
recess 28. The annular channel 38 receives therein a portion of the
top end of the cylindrical sidewall 16 of the body 12, when the
first closure is mounted atop the body. The top end of the
cylindrical sidewall 16 of the body defines an annular tapered
protuberance 40. As can be seen, the tapered protuberance 40
defines a tapered surface 42 on an external side of the sidewall
16. Directly adjacent to the body tapered protuberance 40, opposite
the top end of the body, the body sidewall 16 defines a laterally
extending annular recess 44, extending inwardly from the exterior
of the sidewall.
[0088] The bottom end of the annular sidewall 36 of the first
closure defines a corresponding annular tapered protuberance 46. As
can be seen, the tapered protuberance 46 defines a tapered surface
48 on the interior of the sidewall 36. Thus, when the first closure
22 is mounted atop the body 12, a portion of the sidewall at the
top end of the body is received within the axially-extending
annular channel 38 of the first closure, and the annular tapered
protuberance 46 of the first closure slides past the opposing
annular tapered protuberance 40 of the body and snaps into the
laterally-extending annular recess 44 of the body to create a
fluid-tight seal therebetween. Another annular recess 50 is defined
between the bottom end of the first closure and the
laterally-extending annular projection 20 of the body.
[0089] When the first closure 22 is sealingly mounted atop the body
12, the sealed empty chamber 11 is defined within the body, and the
first penetrable septum 32 is in fluid communication with the
chamber. If the closure 14 and body 12 are sterilized, a sealed,
empty, sterile chamber is thus defined therein. Sterilization of
the closure, body and/or any component parts therein may be
achieved in accordance with the teachings of any of the following
patents and patent applications, each of which is hereby expressly
incorporated by reference in its entirety as part of the present
disclosure as if fully set forth herein: U.S. patent application
Ser. No. 08/424,932, filed Apr. 19, 1995, entitled "Process for
Filling a Sealed Receptacle under Aseptic Conditions," issued as
U.S. Pat. No. 5,641,004; U.S. patent application Ser. No.
09/781,846, filed Feb. 12, 2001, entitled "Medicament Vial Having a
Heat-Sealable Cap, and Apparatus and Method for Filling Vial,"
issued as U.S. Pat. No. 6,604,561, which, in turn, claims benefit
of U.S. Provisional Patent Application No. 60/182,139, filed Feb.
11, 2000, entitled "Heat-Sealable Cap for Medicament Vial;" U.S.
patent application Ser. No. 10/655,455, filed Sep. 3, 2003,
entitled "Sealed Containers and Methods of Making and Filling
Same," issued as U.S. Pat. No. 7,100,646, which, in turn, claims
benefit of similarly titled U.S. Provisional Patent Application No.
60/408,068, filed Sep. 3, 2002; and U.S. patent application Ser.
No. 10/766,172, filed Jan. 28, 2004, entitled "Medicament Vial
Having a Heat-Sealable Cap, and Apparatus and Method for Filling
the Vial," issued as U.S. Pat. No. 7,032,631, which, in turn claims
benefit of similarly titled U.S. Provisional Patent Application No.
60/443,526, filed Jan. 28, 2003 and similarly titled U.S.
Provisional Patent Application No. 60/484,204, filed Jun. 30, 2003.
In addition, the sealed empty chamber may be sterilized with a
fluid sterilant prior to filling, as disclosed in U.S. patent
application Ser. No. 13/529,951, filed Jun. 21, 2012, entitled
"Fluid Sterilant Injection Sterilization Device and Method," which,
in turn, claims the benefit of U.S. Provisional Patent Application
No. 61/499,626, filed Jun. 21, 2011, entitled "Nitric Oxide
Injection Sterilization Device and Method," each of which is hereby
expressly incorporated by reference in its entirety as part of the
present disclosure as if fully set forth herein.
[0090] With the first closure 22 mounted atop the body 12, the
second closure 24 is moveable between a first position (shown in
FIGS. 2D, 3A, 9A and 10A), spaced away from the first closure 22,
and a second position (shown in FIG. 4), where the second closure
24 mounts atop the first closure 22. In the first position, the
second penetrable septum 34 is not sealingly engaging the first
penetrable septum 32. In the second position, on the other hand,
the second penetrable septum 34 sealingly overlies the penetrable
portion of the first penetrable septum 32, thus creating a
mechanical seal, as explained further below.
[0091] As shown in FIG. 2B, the second closure 24 includes an
annular sidewall 52 axially extending from the perimeter of the top
surface thereof, and is configured to fittingly receive the first
closure 24 therein when in the second position. The bottom end of
the second closure annular sidewall 52 defines an annular tapered
protuberance 54. As can be seen, the tapered protuberance 54
defines a tapered surface 56 on the internal side of the sidewall
52. When the second closure 24 is moved from the first position to
the second position, the first closure is fittingly received within
the second closure, the bottom end of the second closure abuts the
laterally-extending annular projection 20 of the body, and the
annular tapered protuberance 54 of the second closure snaps into
the annular recess 50 between the bottom end of the first closure
and the laterally-extending annular projection to secure the second
closure in the second position.
[0092] When in the second position, the second axially-extending
recess 30 of the second closure 24, containing the second
penetrable septum 34 therein, sealingly fits within the first
penetrable septum 32, thereby sealingly engaging the second
penetrable septum atop the penetrable portion of the first
penetrable septum. In the illustrated embodiment, as shown in FIG.
4, the first penetrable septum 32 is approximately dome or convex
shaped on a side thereof opposite the chamber 11. The second
penetrable septum 34 is correspondingly approximately dome or
convex shaped as well on a side thereof substantially opposite the
first penetrable septum 32, in order to sealingly mate with the
contour of the first penetrable septum.
[0093] In order to fill the device 10 with a substance, a filling
device penetrates the first penetrable septum 32, when the second
closure 24 is in the second or open position. An exemplary needle
is disclosed in U.S. patent application Ser. No. 13/450,306, filed
Apr. 18, 2012, entitled "Needle with Closure and Method," which, in
turn, claims benefit of U.S. Provisional Patent Application No.
61/476,523, filed Apr. 18, 2011, entitled "Filling Needle and
Method," each of which is hereby expressly incorporated by
reference in its entirety as part of the present disclosure as if
fully set forth herein.
[0094] In some embodiments, a filling device 60, as shown in FIG.
5, is utilized to fill the device 10. The filling device 60
comprises a hollow filling member 62, a tip 64 formed at one end of
the filling member, two ports 66 in fluid communication with the
interior of the hollow filling member 62, a first or relatively
rigid closure 68, and a second closure or relatively flexible
annular shell 70. The filling member 62 includes a boss 72 at
approximately a middle portion thereof. As can be seen, the boss 72
defines an annularly and axially extending recess therein for
receiving a proximal portion of the closure 68 and a biasing member
74 that engages and biases the closure, as described further below.
In the illustrated embodiments, the two ports 66 are diametrically
opposed relative to each other; however, as may be recognized by
those of ordinary skill in the pertinent art based on the teachings
herein, the filling device may define any number of ports that may
define any of numerous different configurations and locations.
[0095] The closure 68 and/or the filling member 62 is movable
between (i) a first position wherein the closure closes the ports
66, as shown typically in FIG. 6A, and (ii) a second position
opening the ports 66, as shown typically in FIG. 6B. When in the
closed position, the closure 68 forms a substantially fluid-tight
seal between the ports 66 and ambient atmosphere. The closure 68 is
biased via the biasing member 74 in the direction from the second
or open position toward the first or closed position to normally
close the ports 66. In the illustrated embodiment, the biasing
member 74 is a coil spring. However, as may be recognized by those
of ordinary skill in the pertinent art based on the teachings
herein, the closure may be biased in any of numerous different ways
that are currently known or that later become known, using biasing
members other than springs. Further, if a spring is used, any of
numerous different springs or combinations of springs may be used.
In the illustrated embodiment, the closure 68 is a "shutter"
closure that slides axially over the filling member 62 between the
normally closed and open positions. However, as may be recognized
by those of ordinary skill in the pertinent art based on the
teachings herein, the closure may take any of numerous different
configurations that are currently known, or that later become
known, for performing the function of the closure as described
herein.
[0096] The closure 68 extends both annularly and axially about the
filling member 62 and is slidably mounted on the filling member.
The closure 68 includes an annular flange 76 adjacent to a proximal
end thereof that is engageable with the biasing member 74 for
biasing the closure in the direction from the second or open
position toward the first or closed position. An opposing distal
end 78 of the closure 68 is engageable with an annular stop surface
80 of the filling member tip 64 to stop the closure in the first or
closed position. The distal end 78 of the closure 68 tapers
inwardly to define a perimeter substantially flush with the
perimeter of the stop surface 80 and adjacent portion of the
filling member tip 64. As shown in FIGS. 8A and 8B, in alternative
embodiments, the closure 68 (FIG. 8B) and/or the filling member tip
64 (FIG. 8A) includes an annular seal 82, between the distal end 78
of the closure and the tip 64 of the filling member, to further
ensure the formation of a fluid-tight seal at the junction of the
closure and filling member. In the embodiment of FIG. 8A, the seal
82 is o-ring shaped and is over-molded to the filling member tip
64. In the alternative embodiment of FIG. 8B, the O-ring shaped
seal 82 is over-molded to the distal tip of the closure 68. As may
be recognized by those of ordinary skill in the pertinent art based
on the teachings herein, the seal may or may not be integral with
the closure and may take the form of any of numerous different
types of seals or sealing members that are currently known or that
later become known, to facilitate the formation of fluid-tight seal
at the juncture of the closure and filling member. In the
illustrated embodiment, the proximal end of the closure 68 is
slidably received within the annular recess of the boss 72 of the
filling member 62, and the biasing member 74 is located between the
rear wall 84 of the boss 72 and the annular flange 76.
[0097] The flexible closure or shell 70 sealingly encloses the boss
72 of the filling member 62. In the illustrated embodiment, the
flexible shell forms a bellows to allow the shell to axially expand
when moving into the first or closed position (FIG. 6A) and to
axially contract when moving into the second or open position (FIG.
6B). However, as may be recognized by those of ordinary skill in
the pertinent art based on the teachings herein, the flexible shell
may take any of numerous different configurations that are
currently known, or that later become known, for performing the
function of the shell as described herein. The flexible shell
sealingly engages an outwardly projecting annular flange 86 of the
boss 72 near the proximal end thereof, and sealingly engages an
annular flange 88 of the closure 68 at the distal end thereof. In
the illustrated embodiment, the closure annular flange 88 projects
radially outwardly from an approximate mid-portion of the closure
68. The portion of the flexible shell 70 proximally adjacent to the
boss annular flange 86 includes an integrally the boss 72. The boss
72 includes corresponding venting holes 92 located adjacent to the
rear wall 84 that are normally sealed by the valve 90. The venting
holes 92 are in fluid communication with the interior recess of the
boss 72. The interior of the boss 72 is in fluid communication with
one or more annularly and axially extending channels formed between
the closure 68 and filling member 62 which, as shown in FIGS. 7C
and 10C, are in fluid communication with a chamber to be filled
when the closure is located in the second or open position. Thus,
when the biasing member 74 is compressed upon movement of the
closure from the first position to the second position, sufficient
fluid pressure within the boss 72 (i.e., at or above the venting
valve opening pressure) will cause the venting valve 90 to move
radially outwardly relative to the holes 92 to thereby allow
one-way venting of any such air or other gases into the ambient
atmosphere. In addition, as described further below, during
filling, any air or other gases (e.g., nitrogen) that are displaced
from the chamber to being filled are allowed to vent through the
channels between the closure and filling member and, in turn,
through the venting valve 90. When the pressure equalizes, the
valve 90 resiliently returns to its sealing position overlying and
engaging the holes 92. In similar fashion, the venting valve 90
allows one-way venting of air or other gases through the venting
holes 92, and into the shell 72 when a vacuum is present therein.
As may be recognized by those of ordinary skill in the pertinent
art based on the teachings herein, the venting valve may take the
form of any of numerous integral or non-integral valves, that are
currently known or that later becomes known, capable of performing
the function of the venting valve as described herein.
[0098] In the illustrated embodiment, the filling device tip 64 is
defined by a non-coring, conically-pointed tip; however, as may be
recognized by those of ordinary skill in the pertinent art based on
the teachings herein, the filling device tip may define any of
numerous other tip configurations that are currently known, or that
later become known, such as a trocar tip. In one configuration, the
spring force of the biasing member 74 is sufficient to allow the
filling device 60 to penetrate a septum of an opposing device while
maintaining the closure 68 in the closed position during
penetration of the closure through the septum and until the annular
flange 88 of the closure engages an exterior surface of the septum
(or other exterior or stop surface of the device to be filled) to
cause relative movement of the closure and filling member against
the bias of the biasing member 74 from the normally closed position
to the open position and, in turn, expose the sterile filling
device ports 66, 66 within the sterile device chamber.
[0099] A filling line attachment fitting 94 is formed on a proximal
end of the filling member 62. In the illustrated embodiment, the
attachment fitting 94 is a barbed fitting for attachment to a
filling line (not shown). As may be recognized by those of ordinary
skill in the pertinent art based on the teachings herein, any of
numerous different types of fittings, connections or connectors
that are currently known, or that later become known, equally may
be employed for connecting the filling device to a filling or other
type of line or conduit. For example, the proximal end of the
filling device may define a male or a female connector for
aseptically or sterile connecting to the other of the male or
female connector attached to a filling line, as disclosed in U.S.
patent application Ser. No. 13/864,919, filed May 1, 2013, entitled
"Device for Connecting or Filling and Method," which, in turn,
claims benefit of similarly titled U.S. Provisional Application No.
61/794,255, filed Mar. 15, 2013, and similarly titled U.S.
Provisional Patent Application No. 61/641,248, filed May 1, 2012;
and U.S. patent application Ser. No. 13/864,919, filed Apr. 17,
2013, entitled "Self Closing Connector," which, in turn, claims
benefit of similarly titled U.S. Provisional Patent Application No.
61/784,764, filed Mar. 14, 2013, similarly titled U.S. Provisional
Patent Application No. 61/635,258, filed Apr. 18, 2012, and
similarly titled U.S. Provisional Patent Application No.
61/625,663, filed Apr. 17, 2012, each of which is hereby expressly
incorporated by reference in its entirety as part of the present
disclosure as if fully set forth herein.
[0100] The filling device 60 may be used to aseptically or sterile
fill fluids through the first penetrable septum 32 and into the
chamber 11 of the device 10. As shown in FIGS. 7A, 9B and 10A,
prior to penetrating the first septum 32, and when the filling
device tip 64 is exposed to the ambient atmosphere, the closure 68
is in the closed position sealing the ports 66 with respect to
ambient atmosphere to thereby maintain the sterility of the ports
and of the interior of the filling device. As shown in FIGS. 7B and
10B, upon penetrating the first septum 32, the closure 68 remains
interposed between the ports 66 and the first penetrable septum 32
to substantially prevent contact between the ports and the septum.
When the ports 66 are located within the chamber 11, the bottom
surface of the annular flange 88 of the closure engages the top
surface of the first closure 22 and prevents further movement of
the shutter closure 68 relative to the first closure 22. Further
penetration of the filling device 60 into the chamber of the device
10 causes the filling member 62 and filling device tip 64 to slide
relative to the shutter closure 68 against the bias of the biasing
member 74 to, in turn, move the ports 66 to the open position. As
the biasing member 74 is compressed with further movement of the
shutter closure from the closed position to the open position, any
fluid pressure within the shell 72 above of the venting valve
opening pressure is allow to flow through the venting valve 90 into
the ambient atmosphere. In the open position of FIGS. 7C and 10C,
the fluid or other substance within the filling device is permitted
to flow through the open ports 66 and into the chamber 11. Any
fluid within the chamber 11 that is displaced by the substance
flowing into the chamber is allowed to vent through the channels
formed between the shutter enclosure 68 and filling device 62 and,
in turn, through the venting valve 90. Since the sterile ports 66
are never exposed to the ambient atmosphere throughout the filling
process, the ports, interior of the filling device, and fluid
flowing therethrough, are not contaminated and/or are maintained
aseptic or sterile as the fluid is injected or otherwise filled
into the chamber 11.
[0101] In some embodiments, the first septum 32 comprises a lower,
i.e., base, layer having a relatively high durometer and an upper
layer having a relatively lower durometer. In some such
embodiments, the upper layer is not bondable with the lower layer
and is over-molded thereon. In some such embodiments, the first
septum 32 wipes the tip 64 of the filling member 62 and the shutter
closure 68 of contaminants thereon during engagement and
penetration of the septum by the tip to, in turn, prevent the tip
and/or shutter closure from introducing such contaminants into the
sterile interior of the chamber 11 and thereby maintain the chamber
and any substance therein aseptic or sterile. The effectiveness of
such wiping during penetration of the septum is dependent, in part,
upon the pressure applied by the septum onto the tip of the filling
member as it penetrates through, as well as the coefficient of
friction therebetween.
[0102] Several factors affect the pressure applied by the septum
onto the tip. As stated above, the first septum 32 is approximately
dome or convex shaped. The present inventor has determined that the
dome or convex shape increases the internally directed pressure
applied by the septum 32 onto the tip 64 from the beginning of
piercing, as the tip inverts the convexity of the septum in order
to penetrate therethrough. Additionally, the thickness of the
septum (increasing the length of the wiping effect) and durometer
thereof also affect the pressure applied by the septum onto the
tip. In some embodiments, the durometer of the septum 32, or the
layers thereof, is within the range of about 5 Shore A to about 65
Shore A, such as, for example, within the range of about 20 Shore A
to about 50 Shore A. In some such embodiments, the durometer of the
septum 32 is within the range of about 25 Shore A to about 45 Shore
A. In some such embodiments, the septum thickness is within the
range of about 1/2 to about two times the largest diameter of the
tip 64 of the filling member 62.
[0103] The material of the filling member 62 and the septum 32 also
may be selected to enhance the wiping effect. The present inventor
has determined that the use of a plastic filling member provides
the appropriate friction coefficient range to enhance the wiping
effect. Advantageously, the plastic material is also easier to
mold, and thus easier to manufacture and assemble. A septum made of
a homogeneous elastic material defining a substantially homogeneous
density will enhance the wiping effect. In some embodiments, the
filling member 62 is formed of plastic, such as any of numerous
different thermoplastics, including the liquid crystal polymers
(LCP) that are highly crystalline, thermotropic (melt-orienting)
thermoplastics and sold under the trademark Vectra.TM. by Celanese
Corporation, or graphene. In some such embodiments, the first
septum 32 is made of silicone. In other embodiments, the first
septum 32 is made of a vulcanized rubber or a thermoplastic
elastomer. However, as may be recognized by those of ordinary skill
in the pertinent art based on the teachings herein, the filling
member and septum may be made of any of numerous different
materials that are currently known, or that later become known, to
perform the functions of the filling member and septum disclosed
herein.
[0104] The configuration of the filling member itself also enhances
the effectiveness of the wiping effect. The included angle of the
tip 64 of the filling member affects the progressively increasing
thickness of the tip, and the diameter of the filling device, i.e.,
the outer diameter of the shutter closure. As the filling member 62
penetrates through the first septum 32, the internal pressure
applied by the septum onto the tip 64, and thereafter onto a
portion of the rigid closure increases proportionally to the
progressively increasing tip diameter, resulting from the included
angle of the tip. In some embodiments, the included angle of the
tip of the piercing member is within the range of about 20 degrees
to about 40 degrees, and such as about 30 degrees.
[0105] The present inventor has determined that the wiping effect
on a filling member tip by a septum having properties as
aforementioned may achieve at least approximately a 3 log reduction
in bio-burden when filling member tip penetrates a septum while
immersed in a broth, which is about the reduction achieved by known
UV pulse (5 second) sterilization techniques, and up to
approximately a 6 log reduction in bio-burden. Therefore, one
advantage of the present invention is that the wiping of the
filling device tip allows substantially sterile filling of fluids
within a non-aseptic, non-sterile or relatively low sterility
assurance level ("SAL") environment (e.g., about 6 log bio-burden
or lower).
[0106] Another advantage is that the filling device 60 may sterile
fill a substance into the device 10 without the need to
decontaminate the septum of the device or the tip of the filling
device prior to filling. The combination of the maintained
sterility of the ports 66 and interior of the filling device 60, as
well as the wiping effect provided by the first septum 32
effectively sterilize the tip 64 of the filling member 62 upon
penetration of the filling member through the septum. Therefore
sterile filling is achieved without the need to take conventional
sterilization steps, such as the application of UV radiation, for
example. Thus, the combination of the maintained sterility of the
ports 66 and interior of the filling device, as well as the wiping
effect provided by the first septum 32, allows substantially
sterile filling to be achieved in an unclassified environment
(e.g., about log 6 or higher), as explained in U.S. Provisional
Patent Application No. 61/798,210, filed Mar. 15, 2013, entitled
"Controlled Non-Classified Filling Device and Method," which is
hereby expressly incorporated by reference in its entirety as if
fully set forth herein. As should be understood by those of
ordinary skill in the pertinent art, an unclassified environment is
an environment having a number and size of particles per volume
greater than 100,000 particles per cubic meter of 0.5 .mu.m or
larger in diameter, i.e., a class 100,000 environment.
[0107] As shown in FIG. 10D, after the chamber 11 is filled as
desired, the filling device 60 is withdrawn from the first septum
32. As the filling device is withdrawn, the biasing member 74
biases the rigid closure 68 downwardly or in the direction of the
septum 32. Therefore, as the filling member 62 is withdrawn, it is
moved axially relative to the shutter closure 68 to, in turn, move
the ports 66 into the closed position behind the closure. The
shutter closure 68 is configured to substantially prevent contact
between the filling device eyes or ports 66, and as can be seen,
the sliding shutter or closure is closed over the filling device
eyes or ports prior to their passage through the septum and/or
withdrawal therefrom. When the distal end 78 of the closure 68
sealingly reengages the stop surface 80 of the filling device tip
64, the closure is in the closed position, and is maintained in the
closed position by the downward force or bias of the biasing member
74. Thus, during, upon, and before, withdrawal of the filling
device 60 from the first septum 32, the closure 68 sealingly closes
the ports 66 and prevents contamination of the ports or interior of
the filling device.
[0108] The first septum 32 is engineered in a manner known to those
of ordinary skill in the pertinent art to self-close and thereby
ensure that the head loss left by the residual filling device
injection aperture 96 after the tip of the filling device is
withdrawn substantially prevents fluid ingress therethrough.
Thereafter, as shown in FIG. 4, the second closure portion 24 is
moved from the first position, and snaps into the second position,
and the unpenetrated second septum 34 overlies and seals the
injection aperture 96 in the first septum 32 from the ambient
atmosphere. This forms a filled, sealed device as shown in FIGS. 4
and 9C. Prior to moving the second closure 34 from the first
position to the second position, the exterior surface of the first
closure 32 and/or the interior surface of the second closure 24 may
be sterilized, such as is shown in the example of FIG. 3B, in order
to prevent any contaminants from being trapped between the first
and second septums 32 and 34, respectively, after closure of the
second closure to the first closure. Sterilization of these
surfaces may be performed in any of numerous different ways that
are currently known, or that later become known, including without
limitation, by the application of radiation thereto, such as
e-beam, laser or UV radiation, by the application of a fluid
sterilant, such as vaporized hydrogen peroxide ("VHP") or nitric
oxide ("NO"), or by heated gas. In addition, sterilization may be
achieved in accordance with the teachings of any of the following
patents and patent applications, each of which is hereby expressly
incorporated by reference in its entirety as part of the present
disclosure: U.S. patent application Ser. No. 08/424,932, filed Apr.
19, 1995, entitled "Process for Filling a Sealed Receptacle under
Aseptic Conditions," issued as U.S. Pat. No. 5,641,004; U.S. patent
application Ser. No. 09/781,846, filed Feb. 12, 2001, entitled
"Medicament Vial Having a Heat-Sealable Cap, and Apparatus and
Method for Filling Vial," issued as U.S. Pat. No. 6,604,561, which,
in turn, claims benefit of U.S. Provisional Patent Application No.
60/182,139, filed Feb. 11, 2000, entitled "Heat-Sealable Cap for
Medicament Vial;" U.S. patent application Ser. No. 10/655,455,
filed Sep. 3, 2003, entitled "Sealed Containers and Methods of
Making and Filling Same," issued as U.S. Pat. No. 7,100,646, which,
in turn, claims benefit of similarly titled U.S. Provisional Patent
Application No. 60/408,068, filed Sep. 3, 2002; U.S. patent
application Ser. No. 10/766,172, filed Jan. 28, 2004, entitled
"Medicament Vial Having a Heat-Sealable Cap, and Apparatus and
Method for Filling the Vial," issued as U.S. Pat. No. 7,032,631,
which, in turn claims benefit of similarly titled U.S. Provisional
Patent Application No. 60/443,526, filed Jan. 28, 2003 and
similarly titled U.S. Provisional Patent Application No.
60/484,204, filed Jun. 30, 2003; and U.S. patent application Ser.
No. 13/864,919, filed Apr. 17, 2013, entitled "Self Closing
Connector," which, in turn, claims benefit of similarly titled U.S.
Provisional Patent Application No. 61/784,764, filed Mar. 14, 2013,
similarly titled U.S. Provisional Patent Application No.
61/635,258, filed Apr. 18, 2012, and similarly titled U.S.
Provisional Patent Application No. 61/625,663, filed Apr. 17,
2012.
[0109] If desired, a further closure may be applied over the second
closure 24 and/or second septum 34, such as an adhesive-backed foil
layer that overlies the second septum 24 and is adhesively attached
to the second septum or second closure, to provide an additional
barrier such as to prevent moisture-vapor transmission ("MVT").
When ready for use, the adhesive-back foil layer or other
additional MVT barrier may be manually engaged and removed to
expose the second septum. Then, as shown in FIG. 9D, a syringe
needle or like withdrawal device may be pierced through the first
and second septums 32, 34 and placed into fluid communication with
the interior chamber 11 and the fluid or other substance therein to
withdraw the fluid or other substance from the chamber and into the
syringe to, for example, inject the withdrawn substance into a
person. In some embodiments, the first and second septums may be
pierced one or more times as desired to withdraw substance from the
chamber 11 until the chamber is empty as shown in FIG. 9E.
[0110] In another embodiment, the second closure is initially a
separate piece and is not connected to the first closure. After the
first closure is pierced and the device is filled with a substance,
the second closure is then fixedly secured, such as by a snap fit
as described above, to the first closure to sealingly engage the
first and second septums, and seal the resulting penetration
aperture in the first septum. The second closure can be
pre-sterilized prior to assembly, or can be surface sterilized as
described above prior to assembly to the first closure. The second
closure can be automatically assembled to the first closure with
any of numerous different assembly devices that are currently
known, or that later become known, such as a pick and place robotic
assembly device, or other suitable fixture that can automatically
assemble the second closure to the first closure. A closure
assembly station can be located downstream of the needle
penetration and filling station to assemble the second closure to
the first closure upon or following withdrawal of the filling
needle from the first closure.
[0111] In FIGS. 11-12D, another device is indicated generally by
the reference numeral 110. The device 110 is substantially similar
to the device 10 described above in connection with FIGS. 1-4 and
9A-10B, and therefore like reference numerals preceded by the
numeral "1" are used to indicate like elements. A primary
difference of the device 110 in comparison to the device 10 is the
design of the closure 114 and that the first penetrable septum 132
is not integrated into the closure 114. Rather, the first
penetrable septum 132 is separate from the closure and seats into
the opening 118 of the body 112. When the closure 114 mounts atop
the body 112, a lower portion 122 of the closure 114 sealingly
clamps the first penetrable septum 132 into the body opening 118.
An upper portion 124 of the closure 114 defines a
laterally-extending slot 124a configured to slidably receive the
second penetrable septum 134 therein, for sealing the first septum
132 after penetration thereof, as hereinafter described.
[0112] As shown in FIG. 11, the body 112 includes an annular,
laterally-extending flange 120 spaced from the opening 118, and a
neck 113 extending upward from the periphery of the flange 120 to
the opening 118. The first septum 132 includes a corresponding
annular, laterally-extending flange 132a dimensioned for engagement
with the flange 120 of the body 112. The septum 132 also includes
an annular, axially-extending portion 132b, spaced radially
inwardly relative to the flange 132a and projecting axially
downwardly therefrom. When the first septum 132 is mounted into the
opening 118 of the body 112, the portion 132b extends toward the
chamber 111 of the device and sealingly engages the interior
surface of the body sidewall 116 and the flange 132a engages the
flange 120. The closure 114 is mounted atop the first septum 132,
and onto the body 112, to form a compression seal between the
closure 114, first septum 132, and body 112.
[0113] The lower portion 122 of the closure 114 defines a
substantially annular lateral slot 122a therein defining a
substantially annular inner sidewall 136. The ceiling 122b of slot
122a, i.e., the base of the upper portion 124, defines a first
aperture 128 extending between the lower and upper portions 122,
124. The sidewall 136 of the slot 122a includes an annular lip 136a
extending laterally inwardly from the base end of the sidewall 136.
The lip 136a is slightly smaller in diameter than the neck 113.
When the closure 114 is mounted atop the body 112, the slot 122a
receives the neck 113 and the first septum 132 therein. The lip
136a is flexed slightly outwardly by the larger neck 113 during
mounting so it can slide over and past the neck 113. After the lip
136a slides past the bottom of the neck, the lip 136a resiliently
returns to its original size and engages the bottom surface of the
flange 120 of the body 112, in a snap-fit type engagement, to hold
the closure 114 in place. In some embodiments, the neck 113 of the
body 112 defines a slot (not shown) adapted to receive therein a
corresponding tab (not shown) projecting from the interior surface
of the closure 114, such that the closure 114 only mounts onto the
body 112 when the tab and slot align, in a key-and-groove type
configuration. Thus, the closure 114 only mounts onto body 112 in a
designated orientation relative thereto.
[0114] The height of the slot 122a, i.e., the distance between the
ceiling 122b and the lip 136a is approximately the same as the
height of the neck 113. However, the height of the slot 122a is
slightly less than the height of portion of the first septum 132 to
be retained in the slot 122a. Once mounted, then, the ceiling 122b
of the slot 122a abuts the upper surface of the first septum 132
and compresses and/or depresses the first septum 132 into the neck
113 and, in turn, creates a compression seal between the closure
114, the septum 132 and the body 112. Similar to the embodiment
described above, the first septum 132 is approximately dome or
convex shaped on the upper side thereof, opposite the chamber 111.
Thus, an approximately central portion of the convex upper surface
of the septum 132 bulges through the aperture 128 and partially
into the upper portion 124.
[0115] The upper portion 124 of the closure 114 defines the lateral
slot 124a therein. As mentioned above, and slot 124a includes the
first aperture 128 in the base thereof, connecting to the slot
122a. At the upper end thereof, the slot 124a defines a second
aperture 130, substantially vertically aligned with the first
aperture 128, thereby exposing the first penetrable septum 132 for
filling therethrough. The slot 124a also defines an opening 124b in
the sidewall thereof for receiving a disk 125 therethrough and into
the slot 124a. The disk 125 is shaped and configured to fit into
and substantially mate with the corresponding interior shape of the
slot 124a. The disk 125 is dimensioned, relative to the interior
dimensions of the slot 124a, to create a dimensional interference
therewith. For example, the thickness of the slot 124a
(perpendicular to the lateral extent of the slot 124a) is slightly
less than the thickness of the disk 125, and therefore the disk 125
creates an interference fit with the slot 124a when inserted, e.g.,
wedged, therein. Thus, the disk 125 forms a sliding, fluid-tight
seal between itself and the interior surfaces of the walls of the
slot 124a when inserted therein. The disk 125 includes the second
penetrable septum 134. Similar to the embodiment described above,
the second penetrable septum 134 can be co-molded with the disk
125. Alternatively, the second septum 134 can be over-molded onto
the disk 125.
[0116] The disk 125 is initially inserted into the slot 124a in a
first position, as shown in FIG. 12B. In some embodiments, the disk
125 is mechanically inserted into the slot 124a, such as, for
example, via a solenoid operated arm The disk 125 is movable, i.e.,
slideable, within the slot 124a between the first position where
the disk 125 is positioned away from the first septum 132 bulging
through the first aperture 128, and a second position (FIG. 12D)
where the disk 125 is positioned between the first and second
apertures 128, 130, and the second septum 134 overlies the first
septum 132. In the first position, the portion of the upper surface
of the first septum 132 bulging through the first aperture 132 is
exposed to the second aperture 130 for filling therethrough. In the
second position, the second septum 134 sealingly engages, i.e.,
overlies, the bulging portion of the first septum 132. The portion
of the first septum 132 bulging partially into the slot 124a
narrows the thickness of the slot 124a at that location within the
slot, corresponding to the location of the second position of the
disk 125. Accordingly, when the disk 125 is moved into the second
position, the second septum 134 compresses against the bulging
portion of the first septum 134, and, in turn, forms a mechanical
compression seal therewith. The compression force on the disk 125
and second septum 134 assists in maintaining the disk in the second
position, e.g., by friction or wedging, during storage and
subsequent use.
[0117] The assembled device 110, i.e., the body 112, closure 114,
disk 125, first and second septums 132, 134 and/or any component
parts, can be sterilized with the disk 125 in the first position,
as shown in FIG. 12B. Sterilization of the device 100 may be
performed in any of numerous different ways that are currently
known, or that later become known, including without limitation, by
the application of radiation thereto, such as e-beam, laser or UV
radiation, by the application of a fluid sterilant, such as
vaporized hydrogen peroxide ("VHP") or nitric oxide ("NO"), or by
heated gas in accordance with the teachings of any of the patents
and patent applications incorporated by reference above. Once
sterilized, the seal between the disk 125 and the slot 124a
maintains the sterility of the second septum 134 therein.
[0118] With the disk 125 in the first position, a filling device,
such as the filling device 60 disclosed above or in any of the
patents and patent applications incorporated by reference above,
can be advanced through the second aperture 130 to penetrate the
first penetrable septum 132 and aseptically or sterile fill fluid
into the sterile chamber 111 of the device 110 (FIG. 12C). As
described above, in some embodiments the first septum 132 wipes the
tip of the filling member of contaminants thereon during engagement
and penetration of the septum 132 by the tip, to, in turn, prevent
the tip from introducing such contaminants into the sterile
interior of the chamber 111, thereby maintaining the chamber 111
and any substance therein aseptic or sterile.
[0119] After the chamber 111 is filled as desired, the filling
device is withdrawn from the first septum 132. The first septum 132
can be engineered in a manner known to those of ordinary skill in
the pertinent art to self-close and thereby ensure that the head
loss left by the residual filling device injection aperture 196
after the tip of the filling device is withdrawn substantially
prevents fluid ingress therethrough. Thereafter, the disk 125 is
slidably pressed from the first position into the second position
(FIG. 12D), such that the unpenetrated second septum 134 overlies
and seals the injection aperture 196 in the first septum 132 from
the ambient atmosphere in a similar manner as described in the
above embodiment. The disk 125 surrounding the second septum 134
remains in sealing engagement with the interior surfaces of the
slot 124a. Prior to moving the second closure 124 from the first
position to the second position, the bulging surface of the first
closure 132 can be re-sterilized in order to prevent any
contaminants from being trapped between the first and second
septums 132, 134.
[0120] After the device 110 has been filled and the disk 125 has
been moved into the second position, the openings of the filled
device 110, such as opening 124b, can be sealed, such as, for
example, via shrink wrap, to provide an additional barrier. Similar
to the embodiment of device 10 described above, a tamper-proof
layer 115 can be applied over the closure 114 after filling. In the
illustrated embodiment, the tamper-proof layer 115 is an
adhesive-backed foil layer adhesively attached to the closure 114,
overlying the second aperture 130 and the second septum 134. In
addition to sealing the second aperture 130, the foil layer 115
also indicates whether the device 110 has been tampered with after
filling thereof and prior to withdrawing the filled fluid
therefrom.
[0121] When ready for use, a withdrawal device may penetrate or
pierce through the first and second septums 132, 134 to withdraw
fluid from the chamber 111. In some embodiments, the second septum
134 is off-center within the disk 125, so that a withdrawal device
penetrating through the second septum 134, e.g., through the center
thereof, can penetrate through the first septum 132 at a previously
unpenetrated location and not through the injection aperture
196.
[0122] In FIGS. 13-16, another device is indicated generally by the
reference numeral 210. The device 210 is substantially similar to
the device 110 described above in connection with FIGS. 11-12D, and
therefore like reference numerals preceded by the numeral "2" are
used to indicate like elements. A primary difference of the device
210 in comparison to the device 110 is the second penetrable septum
234 is large enough to sealingly cover the first penetrable septum
232 in both the first and the second positions, as hereinafter
described.
[0123] As shown in FIG. 13, the second penetrable septum 234,
within the disk 225, includes a first portion 234a and a second
portion 234b. In the first position of the disk 225 within the slot
224a, as shown in FIG. 14, the first portion 234a of the second
septum 234 is positioned between the first and second apertures
228, 230, and sealingly overlies the bulging portion of the first
septum 232 in similar manner as described above in the embodiment
of device 110.
[0124] The assembled device 210 (FIG. 14), with the disk 225 in the
first position, can be sterilized prior to filling. Similar to the
embodiment of device 110 above, the disk 225 creates a dimensional
interference with the slot 224a, thereby creating a sliding seal
between the disk 225 and the slot 224a. The seal therebetween
maintains the sterility of the second portion 234b of the second
septum 234 in the first position, i.e., during filling. Thereafter,
as shown in FIG. 15, a filling device, such as, for example, the
filling device 60, can be advanced through the second aperture 230,
and, in turn, penetrate both the first portion 234a of the second
septum 234 and the first septum 232 to aseptically or sterile fill
fluid into the sterile chamber 211 of the device 210. Similar to
the embodiments of devices 10, 110 described above, the first
portion 234a of the second septum 234 and the first septum 232, in
some embodiments, wipe the tip of the filling device of
contaminants thereon during engagement and penetration of the
septums thereby to, in turn, prevent the filling device from
introducing such contaminants into the sterile interior of the
chamber 211 and thereby maintain the chamber and any substance
therein aseptic or sterile.
[0125] After the chamber 211 is filled as desired and the filling
device is withdrawn from the first septum 232 and, in turn, from
the first portion 234a of the second septum 234, the disk 225 is
slidably pressed from the first position (FIG. 15) into the second
position (FIG. 16). The first portion 234a of the second septum 234
is sealed off from the remainder of the device 210 when the disk
225 is moved from the first position into the second position. As
shown, the first portion 234a of the septum 234 defines a
substantially concave upper surface. Accordingly, in the second
position, the portions of the disk 225 and the second septum 234
surrounding the first portion 234a of the second septum and
sealingly engaging the interior surfaces of the upper and lower
walls of the slot 224a, trap, i.e., seal off, any contamination
residing on the first portion 234a in the pocket between the
concave surface and the upper wall of the slot 224a, e.g., from
contact with and wiping of the tip of the filling member 60.
[0126] In the second position, as shown in FIG. 16, the sterile,
unpenetrated second portion 234b of the second septum 234 is
positioned between the first and second apertures 228, 230, and
sealingly overlies the bulging portion of the first septum 232.
Thus, the fluid within the chamber 211 is hermetically sealed. The
first septum 232 is covered by the second septum 234 before, during
and after penetration thereof, and thus the upper surface of the
first septum 232 is never exposed to the ambient atmosphere and
remains substantially sterile, particularly in embodiments where
the second septum 234 wipes the injection member 60. Therefore, no
re-sterilization is required after filling. A needle or like
withdrawal device can thereafter penetrate the second portion 234b
of the second septum 234 and the first septum 232 to withdraw
liquid from the chamber 211, in a similar manner as described
above.
[0127] In FIGS. 17-18, another device is indicated generally by the
reference numeral 310. The device 310 is substantially similar to
the devices 110, 210 described above in connection with FIGS.
11-16, and therefore like reference numerals preceded by the
numeral "3" are used to indicate like elements. A primary
difference of the device 310 in comparison to the devices 110, 210
is that the device 310 includes a single penetrable septum 334. The
septum 334 defines a first portion 334a for filling therethrough
when the disk 325 is located in the first position and a second
portion 334b for sealing the contents of the device 310 and
withdrawing substance therefrom when the disk 325 is located in the
second position, as hereinafter described.
[0128] As shown in FIG. 17, the device 310 comprises a body 312, a
closure 314 and a disk 325 including the penetrable septum 334. The
closure 314 is sealingly mounted atop the upper end of the body
312. The upper rim of the body 312 defines an annular spike 312a
that sealingly engages the base surface of the closure 314. The
closure 314 includes an annular, axially-extending projection 314a,
spaced radially inwardly relative to the perimeter of the closure
314 and projecting axially downwardly from the base of the closure
314. The projection 314a is dimensioned to sealingly engage a
portion of the body sidewall 316 adjacent the opening 318 thereof.
In some embodiments, the diameter of the projection 314a is
dimensioned, relative to the outer diameter of the body 312, to
create a dimensional interference therewith, thereby creating a
fluid-tight interference fit therebetween.
[0129] The closure 314 defines a lateral slot 324a. The slot 324a
defines a first aperture 328 in the base end thereof, connecting
the slot 324a in fluid communication with the chamber 311 of the
device 310. The slot 324a also defines a second aperture 330 in the
upper end thereof substantially vertically aligned with the first
aperture 328. The slot 324a has an opening 324b in the sidewall
thereof for receiving the disk 325, with the penetrable septum 334,
therethrough. Similar to the embodiments of devices 110 and 210
above, the disk 325 is shaped to mate with the corresponding
interior shape of the slot 324a and is dimensioned to create a
dimensional interference therewith. Thus, the disk 325 forms a
sliding, fluid-tight seal between itself and the interior surfaces
of the slot 324a.
[0130] The disk 325 is initially inserted into the slot 324a into
the first position, as shown in FIG. 18. In the first position, the
first portion 334a of the penetrable septum 334 is positioned
between the first and second apertures 328, 330 and forms a sealed,
assembled device. The sealed, assembled device 310, with the disk
325 in the first position, can be sterilized prior to filling. Once
sterilized, the seal between the disk 325 and the slot 324a
maintains the sterility of the second portion 324b of the septum
334 while in the first position, e.g., during filling.
[0131] As shown in FIG. 19, a filling device, such as, for example,
the filling device 60, can penetrate through the first portion 334a
of the septum 334 as described above to aseptically or sterile fill
fluid into the sterile chamber 311 of the device 310. Similar to
the embodiments described above, the septum 334, in some
embodiments, wipes the tip of the filling device of contaminants
thereon during engagement and penetration of the septum by the
filling device to, in turn, prevent the filling device from
introducing such contaminants into the sterile interior of the
chamber 311.
[0132] After the chamber 311 is filled as desired and the filling
device is withdrawn from the septum 334, the disk 325 is slidingly
pressed from the first position into the second position (FIG. 20),
such that the sterile, unpenetrated second portion 334b is
positioned between the first and second apertures 328, 330. Because
of the seal between the disk 325 and the slot 324a, and because the
second portion 334b is unpenetrated, the fluid within the sterile
chamber 311 is hermetically sealed. The first portion 334a of the
septum 334 is also sealed off from the remainder of the device 310
when the disk 325 is moved from the first position into the second
position. As shown, the first portion 334a of the septum 334
defines substantially concave upper and lower surfaces, which
function similar to the concave surface of the septum 234 of device
210. Accordingly, in the second position, the portions of the disk
325 and the septum 334 surrounding the first portion 334a of the
septum and sealingly engaging the interior surfaces of the slot
324a, trap, i.e., seal off, any contamination, such as liquid
residue, residing on the first portion 334a in the pockets between
the concave surfaces of the first portion 334a of the septum 334
and the respective upper and lowers walls of the slot 324a.
[0133] In FIGS. 21-23, another device is indicated generally by the
reference numeral 410. The device 410 is substantially similar to
the devices 10, 110, 210, 310 described above in connection with
FIGS. 1-20, and therefore like reference numerals preceded by the
numeral "4" are used to indicate like elements. A primary
difference of the device 410 in comparison to the devices 10, 110,
210, 310 is that the device 410 includes a closure 414 that is
rotatable relative to the body 412 to selectively expose a filling
septum 432 and a withdrawal septum 434, as hereinafter
described.
[0134] As shown in FIG. 21, the device 410 includes a body 412, a
septum assembly 433, and a closure 414. The septum assembly 433
comprises a penetrable bottom septum layer 433a and an overlay
layer 433b. The overlay layer 433b defines two apertures, receiving
therein corresponding projections of the septum layer 433a to
define a penetrable filling septum 432 and a separate penetrable
withdrawal septum 434. The septum layer 433a, and thus the filling
and withdrawal septums 432, 434 can be made of an elastomeric
material, such as, for example, silicone, vulcanized rubber or a
thermoplastic elastomer, as described above. The septum assembly
433 is shaped and dimensioned to mount into the neck 413 and engage
the flange 420 of the body 412. The septum assembly includes
diametrically opposed tabs 433c fittingly engageable with
corresponding diametrically opposed slots 413a in the neck 413 of
the body 412. Thus, the septum assembly 433 is not rotatable within
the neck 413. Those of ordinary skill in the art should appreciate,
though, that the septum assembly and neck may have fewer (e.g.,
one) or more two tabs and slots, respectively, which in any case
need not be diametrically opposed, or no tabs/slots at all.
[0135] The closure 414 mounts atop the body 412 and forms a
compression seal between the closure 414, the septum assembly 433,
and the body 412 in similar manner as described above with respect
to the embodiment of device 110. The closure 414 includes an
aperture 428 in the upper surface thereof and is assembled onto the
body 412 in a first position or orientation relative to the septum
assembly such that the aperture 428 is positioned above or over the
filling septum 432, as shown in FIG. 22. In the first position with
the filling septum 432 exposed, the seal between the closure 414
and the remainder of the septum assembly 433 maintains the
sterility of the remainder of the assembly 433.
[0136] The closure 414 is rotatable about the neck 413 from the
first position into a second position, to, in turn, position the
aperture 428 above withdrawal septum 434, as shown in FIG. 23. Due
to the above-discussed compression seal, the seals between the body
412, septum assembly 433, and closure 414 are maintained during
rotation. Once rotated into the second position, a tab 433d
projecting upwardly from the overlay layer 433b engages a
corresponding slot or recess in the upper end of the closure 414
(not shown), thereby substantially preventing reverse rotation of
the closure 414 from the second position back toward the first
position (or at least prevent inadvertent rotation).
[0137] Similar to the embodiments described above, the assembled
device 410 can be sterilized in like manner prior to filling.
Thereafter, with the closure 414 in the first position, a filling
device, such as the filling device 60 disclosed above or in any of
the patents and patent applications incorporated by reference
above, can be advanced through the aperture 428 to penetrate the
filling septum 432 and aseptically or sterile fill fluid into the
sterile chamber 411 of the device 410. As described above, in some
embodiments the filling septum 432 wipes the tip of the filling
member of contaminants thereon during engagement and penetration of
the septum 432 by the tip, to, in turn, prevent the tip from
introducing such contaminants into the sterile interior of the
chamber 411, thereby maintaining the chamber 411 and any substance
therein aseptic or sterile.
[0138] After the chamber 411 is filled as desired, the filling
device is withdrawn from the filling septum 432. The closure 414 is
then rotated into the second position, covering and sealing off the
penetrated filling septum 432, thereby hermetically sealing the
fluid within the sterile chamber 411. In the second position, the
unpenetrated, sterile withdrawal septum 434 is exposed. A
withdrawal device may thereafter penetrate through the septum 434
to withdraw the fluid from the chamber 411.
[0139] As may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, numerous changes and
modifications may be made to the above-described and other
embodiments of the present invention without departing from its
scope as defined in the claims. For example, the components of the
container or other device and the filling device may be made of any
of numerous different materials that are currently known, or that
later become known, for performing the function(s) of each such
component. Similarly, the components of the container or other
device and filling device may take any of numerous different shapes
and/or configurations. Also, the filling device may be used to
inject any of numerous different types of fluids or other
substances into the container or other device for any of numerous
different applications, including, for example, medicaments,
pharmaceuticals, vaccines, liquid nutrition products, supplements,
and numerous other products that are currently known, or that later
become known. Accordingly, this detailed description of embodiments
is to be taken in an illustrative, as opposed to a limiting
sense.
* * * * *