U.S. patent application number 15/799482 was filed with the patent office on 2018-03-08 for multiple dose vial and method.
The applicant listed for this patent is Dr. Py Institute LLC. Invention is credited to Daniel Py.
Application Number | 20180064606 15/799482 |
Document ID | / |
Family ID | 48779152 |
Filed Date | 2018-03-08 |
United States Patent
Application |
20180064606 |
Kind Code |
A1 |
Py; Daniel |
March 8, 2018 |
Multiple Dose Vial and Method
Abstract
A vial for storing multiple doses of a substance to be dispensed
into one or more syringes or other delivery devices. The vial has a
body, a storage chamber within the body for storing multiple doses
of the substance therein, a sterile filter configured to sterilize
air or other gas flowing into the storage chamber through the
filter, and a one-way valve connectable in fluid communication with
a syringe or other delivery device. The one-way valve is moveable
relative to the body between first and second positions (i) one of
which permits the valve to open so that substance from the storage
chamber can flow therethrough and into the syringe or other
delivery device connected in fluid communication therewith, and
(ii) one of which prevents the valve from opening.
Inventors: |
Py; Daniel; (Larchmont,
NY) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Dr. Py Institute LLC |
New Milford |
CT |
US |
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Family ID: |
48779152 |
Appl. No.: |
15/799482 |
Filed: |
October 31, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13744379 |
Jan 17, 2013 |
9801787 |
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15799482 |
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61587525 |
Jan 17, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61J 1/1406 20130101;
A61J 1/22 20130101; A61J 1/1475 20130101; A61M 39/24 20130101; A61J
1/10 20130101; A61J 1/2096 20130101 |
International
Class: |
A61J 1/20 20060101
A61J001/20; A61J 1/14 20060101 A61J001/14; A61J 1/10 20060101
A61J001/10; A61M 39/24 20060101 A61M039/24 |
Claims
1. A device comprising: a body; a storage chamber defined within
the body for storing substance therein; a sterile filter coupled in
fluid communication between the storage chamber and ambient
atmosphere, and configured to allow air or other gas to flow from
the ambient atmosphere therethrough into the storage chamber, and
to sterilize air or other gas flowing into the storage chamber
through the filter; and a one-way valve connected or connectable in
fluid communication with substance in the storage chamber and
configured to allow fluid to flow in one direction therethrough but
prevent ingress of fluid in an opposite direction, wherein the
one-way valve is moveable between first and second positions, and
further having a closed position preventing substance from passing
therethrough and an open position permitting substance to pass
therethrough; wherein, in the first position, the one-way valve is
prevented from opening from the closed position into the open
position, so that substance cannot pass through the one-way valve
at any time in the first position, and in the second position the
one-way valve is permitted to open into the open position, so that
substance from the storage chamber may flow through and out of the
one-way valve.
2. A device as defined in claim 1, wherein the one-way valve
includes an elastic valve member a normally closed, valve seam that
substantially prevents the passage of fluid therethrough when a
pressure differential across the valve is less than a valve opening
pressure, and allows the passage of fluid therethrough when a
pressure differential across the valve exceeds the valve opening
pressure when the one-way valve is in the second position.
3. A device as defined in claim 2, wherein the one-way valve
includes a valve seat, and the elastic valve member engages the
valve seat and forms the valve seam therebetween.
4. A device as defined in claim 3, wherein one or more of (i) the
elastic valve member defines a progressively decreasing wall
thickness in a direction from an inlet toward an outlet of the
valve seam, or (ii) the valve seat defines a progressively
increasing width or diameter in a direction from an inlet toward an
outlet of the valve seam.
5. A device as defined in claim 1, further including a penetrable
and resealable portion in fluid communication with the storage
chamber that is penetrable by a needle, filling or injection member
to form a penetration aperture therein for introducing substance
into the storage chamber and is hermetically resealable to
hermetically seal the penetration aperture.
6. A device as defined in claim 5, wherein the penetrable and
resealable portion is resealable by one or more of a liquid sealant
or the application of radiation or energy thereto.
7. A device as defined in claim 1, further comprising a connector
located downstream of an outlet of the one-way valve, wherein the
connector is adapted for connection thereto by a syringe or other
delivery device.
8. A device as defined in claim 7, wherein the connector is a Luer
connector.
9. A device as defined in claim 1, wherein the one-way valve is
normally biased in a direction from the second position toward the
first position.
10. A device as defined in claim 9, further including a spring that
normally biases the one-way valve in a direction from the second
position toward the first position.
11. A device as defined in claim 10, wherein the spring is formed
integral with the valve member.
12. A device as defined in claim 1, wherein (i) in the first
position, the one- way valve is engaged with a surface of the
device that substantially prevents the one-way valve from opening
into the open position, and (ii) in the second position, the
one-way valve is sufficiently disengaged from the surface of the
device to permit the valve to open into the open position.
13. A device as defined in claim 12, wherein the one-way valve
includes a valve seat and a valve member normally engaging the
valve seat to define the closed position, the valve member being
movable relative to the valve seat when a pressure differential
across the one-way valve exceeds a valve opening pressure thereof
when the one-way valve is in the second position, and in the first
position, the surface of the device substantially prevents movement
of the valve member relative to the valve seat, and in the second
position, the valve member is sufficiently disengaged from the
surface to permit movement of the valve member relative to the
valve seat.
14. A device as defined in claim 13, wherein the valve seat and
valve member are moveable together relative to the surface of the
device between the first and second positions.
15. A device as defined in claim 13, wherein the surface of the
device engageable with the valve member extends substantially
annularly about the valve member.
16. A device as defined in claim 13, further comprising a connector
located downstream of an outlet of the one-way valve, wherein the
connector is adapted for connection thereto by a syringe or other
delivery device, and connection of the syringe or other delivery
device causes the valve to move in a direction from the first
position to the second position.
17. A device as defined in claim 16, wherein the connector defines
the surface of the device engageable with the valve member in the
first position.
18. A device as defined in claim 16, wherein the valve seat is
configured so that the syringe or other delivery device engages the
valve seat when connected to the device and moves the valve in a
direction from the first position toward the second position.
19. A device as defined in claim 16, wherein the connector is a
Luer connector.
20. A device as defined in claim 19, wherein the connector a male
or female Luer connector adapted to connect to a respectively
corresponding female or male Luer connector of the syringe or other
delivery device.
21. A device as defined in claim 20, wherein the Luer connector is
a threaded or slip fit Luer connector.
22. A device as defined in claim 1, wherein the sterile filter
includes a micro-filter.
23. A device as defined in claim 1, wherein the base end comprises
a base closure sealingly enclosing the body at the base end
thereof, and the base closure includes the penetrable and
resealable portion and the sterile filter.
24. A device as defined in claim 1, defining a first end and a
second end opposite the first end relative to the storage chamber,
wherein the one-way valve is located substantially at the first end
and the sterile filter is located substantially at the second
end.
25. A device as defined in claim 24, further including a penetrable
and resealable portion located substantially at the second end,
wherein the penetrable and resealable portion is in fluid
communication with the storage chamber, is penetrable by a needle,
filling or injection member to form a penetration aperture therein
for introducing substance into the storage chamber, and is
hermetically resealable to hermetically seal the penetration
aperture.
26. A device comprising: first means for storing substance therein;
second means for moving between first and second positions, for
allowing substance to flow through the first means in one direction
therethrough and preventing ingress of substance in an opposite
direction, and for preventing substance from passing through the
second means in a closed position and for permitting substance to
pass through the second means in an open position; third means for
preventing the second means from opening into the open position in
the first position, and for permitting the second means to open
into the open position in the second position; and fourth means for
being in fluid communication between the first means and ambient
atmosphere, for allowing air or other gas to flow therethrough into
the first means, and for sterilizing air or other gas flowing
therethrough into the first means.
27. A device as defined in claim 26, further comprising fifth means
for penetrating with a needle, filling or injection member, for
forming a penetration aperture therein with the needle, filling or
injection member, for introducing substance into the first means,
and for hermetic resealing to hermetically seal the penetration
aperture.
28. A device as defined in claim 26, wherein the first means is a
body defining a storage chamber therein, the second means is a
one-way valve, the third means is a surface of one or more of a
body of the device or the connector that is engageable with the
one-way valve in the first position, the fourth means is a sterile
filter, and the fifth means is a penetrable and resealable
portion.
29. A method comprising: i. storing substance in a storage chamber
of a device, the device further comprising: a sterile filter
coupled in fluid communication between the storage chamber and
ambient atmosphere, and configured to allow air or other gas to
flow from the ambient atmosphere therethrough into the storage
chamber, and to sterilize air or other gas flowing into the storage
chamber through the filter; and a one-way valve connected or
connectable in fluid communication with substance from the storage
chamber and configured to allow fluid to flow in one direction
therethrough but prevent ingress of fluid in an opposite direction,
wherein the one-way valve is moveable between first and second
positions, and further having a closed position preventing
substance from passing therethrough and an open position permitting
substance to pass therethrough, wherein, in the first position, the
one-way valve is prevented from opening from the closed position
into the open position, so that substance cannot pass through the
one-way valve at any time in the first position, and in the second
position the one-way valve is permitted to open into the open
position, so that substance from the storage chamber may pass
through and out of the one-way valve; ii. moving the one-way valve
from the first position to the second position; iii. in the second
position, moving the valve from the closed position to the open
position; vi. passing substance from the storage chamber through
the one-way valve; v. flowing air or other gas from ambient
atmosphere into the storage chamber through the sterile filter; and
vi. sterilizing the air or other gas flowing through the sterile
filter into the storage chamber.
30. A method as defined in claim 29, wherein step (iii) includes
generating a pressure differential across the one-way valve that
exceeds a valve opening pressure thereof.
31. A method as defined in claim 29, wherein the one-way valve
includes a valve seat and a valve member normally engaging the
valve seat to define a closed position, the valve member being
movable relative to the valve seat when a pressure differential
across the one-way valve exceeds a valve opening pressure thereof
to define an open position, and step (ii) includes moving the valve
seat and valve member together relative to a surface of the device
between the first and second positions.
32. A method as defined in claim 29, further including preventing
the one-way valve from opening from the closed position to the open
position in the first position by engaging the one-way valve with a
surface of the device.
33. A method as defined in claim 32, wherein step (ii) includes
sufficiently disengaging the one-way valve from the surface of the
device to permit the valve to open into the open position.
34. A method as defined in claim 33, wherein the one-way valve
includes a valve seat and a valve member normally engaging the
valve seat to define the closed position, the valve member being
movable relative to the valve seat when a pressure differential
across the one-way valve exceeds a valve opening pressure thereof
when the one-way valve is in the second position, the preventing
step includes engaging the valve member with the surface of the
device and substantially preventing movement of the valve member
relative to the valve seat, and step (ii) includes sufficiently
disengaging the valve member from the surface of the device to
permit movement of the valve member relative to the valve seat.
35. A method as defined in claim 29, wherein the storage chamber
and substance are sterile or aseptic, and the method further
comprises maintaining the substance in the storage chamber sterile
or aseptic at least throughout steps (i) through (vi).
36. A method as defined in claim 29, wherein step (ii) comprises
engaging the one-way valve with the syringe or other delivery
device.
37. A method as defined in claim 29, wherein the device defines a
first end and a second end opposite the first end relative to the
storage chamber, wherein the one-way valve is located substantially
at the first end and the sterile filter is located substantially at
the second end.
38. A method as defined in claim 34, wherein the device further
comprises a penetrable and resealable portion located substantially
at the second end and in fluid communication with the storage
chamber, and the method further comprises: penetrating the
penetrable and resealable portion with a needle, filling or
injection member; introducing substance through the needle, filling
or injection member and into the storage chamber; and hermetically
resealing a resulting penetration aperture in the penetrable and
resealable portion.
39. A method as defined in claim 29, further comprising preventing
germs, contaminants, air, or other gas from entering the device
through the one-way valve.
40. A method as defined in claim 29, further comprising biasing the
one-way valve in a direction from the second position toward the
first position.
41. A method as defined in claim 29, further comprising connecting
a syringe or other delivery device in fluid communication with the
one-way valve and performing step (ii) with the syringe or other
delivery device, and performing step (iii) by creating at least a
partial vacuum in the syringe or other delivery device and
generating a pressure differential across the one-way valve that
exceeds a valve opening pressure thereof.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation application of co-pending
U.S. patent application Ser. No. 13/744,379, filed Jan. 17, 2013,
entitled "Multiple Dose Vial and Method," now U.S. Pat. No.
9,801,787, issued Oct. 31, 2017, which claims priority to
similarly-titled U.S. Provisional Patent Application No 61/587,525,
filed Jan. 17, 2012, all of which are hereby incorporated by
reference in its entirety as part of the present disclosure.
SUMMARY OF THE INVENTION
[0002] The present invention relates to fluid storage and
dispensing devices, such as vials, and more particularly, to such
devices for storing multiple doses of the substances to be
dispensed.
BACKGROUND INFORMATION
[0003] A typical vial, such as a medicament vial, includes a vial
body defining a chamber for storing a substance to be dispensed,
such as a medicament, and a needle-penetrable stopper received
within a mouth of the vial body that seals the medicament or other
substance within the chamber. In order to withdraw the substance
from the vial, the following steps are typically performed. First,
the physician or the nurse must fill the syringe with air, and such
air, particularly from a hospital, is not sterile. Second, the
stopper must be pierced with the syringe needle in order to place
the needle tip in fluid communication with the vial chamber. Third,
the non-sterile air from the syringe is injected into the vial with
enough pressure for the compressed air to replace the volume of
liquid pulled into the syringe. Fourth, the vial is put upside
down, with the syringe needle vertically beneath the vial, for the
liquid of the vial to be drained from the open end of the needle.
Then, the plunger of the syringe is pulled vertically downward to,
in turn, draw the liquid into the syringe through the immerged tip
of the needle in the upside-down vial. Once the syringe is filled,
if air has been drawn into the syringe, it is forced out by pushing
the plunger with the syringe in the upside-down position in order
to eject any air up to the first drop of liquid pushed into the
syringe needle. Then, the syringe is used to inject the withdrawn
medicament or other substance into, or to otherwise administer it
to, a patient.
[0004] One of the drawbacks of such a typical known vial is that
each time the stopper is pierced with a syringe needle to withdraw
a dose of medicament or other substance, the syringe has to be
pre-filled with contaminated air from the environment. The needle
also can accidentally contact the fingers of the medical personnel
or other contaminated surfaces and, as a result, introduce more
germs, bacteria or other contaminants into the vial chamber.
[0005] A second drawback is that the air injected during previous
withdrawals from a multiple dose vial can lead to the reproduction
of germs initially contained in the air and injected into the vial.
The first withdrawal of the liquid out of a multiple dose vial may
be contaminated by the ambient air initially injected into the vial
as described above, but between the air injection into the vial and
the withdrawal of the liquid, there is not enough time for the
germs contained in the air to reproduce in many colonies. However,
it can be increasingly dangerous to withdraw liquid from that vial
when the amount of dose already withdrawn has been in contact with
the germs of previous injections of air into the vial. Accordingly,
such vials cannot be safely used to dispense multiple doses of the
medicament or other substance without risk of contaminating the
substance remaining within the vial chamber after multiple doses
have been withdrawn.
[0006] A third drawback of the traditional method is that the
needle may accidentally stick the skin of the medical personnel,
and as a result, may transfer to the patients, contaminants from
the blood of the medical personnel, such as hepatitis, a
professional disease of medical personnel in general, AIDS, or
other ailments.
[0007] Yet another drawback is due to the needle transfer when
medical personnel withdraw the needle from the vial after the
syringe has been filled. At that time the finger of the physician
or nurse can be accidentally stuck by the needle and thereby
infected with a product contaminated by germ growth in the multiple
dose container.
SUMMARY OF THE INVENTION
[0008] 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. In accordance with a first aspect, a device for storing
multiple doses of a substance to be dispensed into one or more
syringes or other delivery devices comprises a body, a storage
chamber within the body for storing multiple doses of the substance
therein; and a valve, such as a one-way valve, connectable in fluid
communication with a syringe or other delivery device and moveable
between first and second positions, and having a closed position
preventing substance from passing therethrough and an open position
permitting substance to pass therethrough. In the first position
the one-way valve is prevented from opening into the open position
and substance from the storage chamber cannot pass therethrough,
and in the second position the one-way valve is permitted to open
into the open position so that the one-way valve permits substance
from the storage chamber to flow therethrough and into the syringe
or other delivery device connected in fluid communication
therewith.
[0009] In some embodiments, the device includes a sterile filter
coupled in fluid communication between the storage chamber and
ambient atmosphere, and the sterile filter is configured to allow
air or other gas to flow from the ambient atmosphere therethrough
into the storage chamber, and to sterilize air or other gas flowing
into the storage chamber through the filter.
[0010] In some embodiments, the one-way valve is configured to
substantially prevent any fluid flow in a substantially opposite
direction, from the syringe or other delivery device, therethrough,
and into the storage chamber.
[0011] In some embodiments, the one-way valve includes an elastic
valve member defining a normally closed, valve seam that
substantially prevents the passage of fluid therethrough when a
pressure differential across the valve is less than a valve opening
pressure, and allows the passage of fluid therethrough when a
pressure differential across the valve exceeds the valve opening
pressure. In some such embodiments, the one-way valve includes a
valve seat, and the elastic valve member engages the valve seat and
forms the valve seam therebetween. In some such embodiments, (i)
the elastic valve member defines a progressively decreasing wall
thickness in a direction from an inlet toward an outlet of the
valve seam, and/or (ii) the valve seat defines a progressively
increasing width or diameter in a direction from an inlet toward an
outlet of the valve seam.
[0012] In some embodiments, the device includes a penetrable and
resealable portion or septum that is penetrable by a needle,
filling or injection member for filling the storage chamber with
substance to be dispensed, and is resealable to hermetically seal a
resulting penetration aperture in the septum. In some such
embodiments, the septum is resealable by a liquid sealant,
radiation, and/or the application of thermal energy thereto.
[0013] In some embodiments, the one-way valve is normally biased in
a direction from the second position toward the first position. In
some such embodiments, the device includes a spring that normally
biases the one-way valve in the direction from the second position
toward the first position. In some embodiments, the spring is an
elastic spring, such as an approximately dome-shaped spring or an
approximately bellows-shaped spring.
[0014] In some embodiments, (i) in the first position, the one-way
valve is engaged with a surface of the device that substantially
prevents the one-way valve from opening into the open position, and
(ii) in the second position, the one-way valve is sufficiently
disengaged from the surface of the device to permit the valve to
open into the open position. In some embodiments, the one-way valve
includes a valve seat and a valve member normally engaging the
valve seat to define the closed position, the valve member being
movable relative to the valve seat when a pressure differential
across the one-way valve exceeds a valve opening pressure thereof.
In the first position, the surface of the device substantially
prevents movement of the valve member relative to the valve seat.
In the second position, the valve member is sufficiently disengaged
from the surface to permit movement of the valve member relative to
the valve seat. In some such embodiments, the surface of the vial
engageable with the valve member extends substantially annularly
about the valve member.
[0015] Some embodiments further comprise a connector located
adjacent (e.g., downstream) to an outlet of the one-way valve. The
connector is adapted to connect thereto the syringe or other
delivery device. In some embodiments, the connector is a Luer
connector. In some embodiments, connection of the syringe or other
delivery device to the connector causes the valve to move in the
direction from the first position to the second position. In some
such embodiments, the connector defines a surface of the vial
engageable with the valve member in the first position to prevent
valve opening. In some embodiments, the one-way valve includes a
valve seat, and the syringe or other delivery device engages the
valve seat to cause the valve to move in a direction from the first
position toward the second position.
[0016] In some embodiments, the storage chamber is hermetically
sealed with respect to ambient atmosphere, is sterile, and includes
therein multiple doses of a sterile or aseptic substance. The
one-way valve substantially prevents fluid and germ ingress, such
as air, therethrough and into the storage chamber.
[0017] In some embodiments, the body includes a sliding seal
received therein and spaced relative to the one-way valve, wherein
the storage chamber is a variable-volume storage chamber defined
within the body between the sliding seal and the one-way valve.
[0018] In some embodiments, the devices further comprises a base
closure sealingly enclosing the body at an opposite side of the
body from the one-way valve, and a flexible bladder integrally
formed with the base closure and projecting therefrom toward the
one-way valve, wherein the storage chamber is a variable-volume
storage chamber defined between the flexible bladder and the body.
In some such embodiments, the flexible bladder is configured to
collapse when the variable-volume storage chamber is filled and
expands when substance is dispensed from the variable-volume
storage chamber.
[0019] In accordance with another aspect, a device for storing
multiple doses of a substance to be dispensed into one or more
syringes or other delivery devices comprises first means for
storing therein multiple doses of the substance, second means for
coupling in fluid communication with a syringe or other delivery
device and for moving between first and second positions, and for
preventing substance from passing through the second means in a
closed position and for permitting substance to pass through the
second means in an open position, and third means for preventing
the second means from opening into the open position in the first
position, and for permitting the second means to open into the open
position in the second position.
[0020] Some embodiments further include fourth means for
penetrating with a needle, filling or injection member, and sterile
or aseptic filling the substance into the first means. In some such
embodiments, the third means is a penetrable and resealable portion
or septum.
[0021] Some embodiments include means for sterile or aseptic
filling the substance into the first means comprising a smooth and
non-piercing probe for injecting the fluid through a one-way valve,
including a valve comprising a depressible, approximately
dome-shaped spring, or other type of elastic spring, with
mechanical self-closing properties, after filling and withdrawal of
the probe.
[0022] Some embodiments further comprise fifth means for connecting
thereto the syringe or other delivery device. Some embodiments
further comprise sixth means for biasing the second means in the
direction from the first position toward the second position. In
some embodiments, the first means is a storage chamber (defining
either a fixed or variable volume), the second means is a one-way
valve, the fifth means is a connector, the sixth means is a spring,
the third means is a surface of a body of the device and/or a
connector that is engageable with the one-way valve in the first
position.
[0023] In accordance with another aspect, a method comprises the
following steps:
i. storing multiple doses of a substance to be dispensed in a
storage chamber and sealing the stored multiple doses with respect
to ambient atmosphere; ii. connecting a syringe or other delivery
device in fluid communication with a one-way valve in fluid
communication with the storage chamber; iii. dispensing a dose of
substance from the storage chamber through the one-way valve and
into the syringe or other delivery device; iv. substantially
preventing ambient fluid from passing through the one-way valve and
into the storage chamber during step iii; and v. repeating steps ii
through iv with the same multiple dose device.
[0024] In some embodiments, step (iii) includes creating at least a
partial vacuum in the syringe or other delivery device and, in
turn, creating a pressure differential across the one-way valve
that exceeds a valve opening pressure thereof. Some embodiments
further include, during or after step ii, moving the one-way valve
from (i) a first position where the one-way valve is prevented from
opening into an open position wherein substance may pass
therethrough, to (ii) a second position where the one-way valve is
permitted to open into the open position and substance may pass
therethrough. Some embodiments further include engaging the one-way
valve with the syringe or other delivery device, and moving the
one-way valve in the direction from the first position toward the
second position during or after connecting the syringe or other
delivery device to the multiple dose device. Some embodiments
further comprise maintaining the substance in the storage chamber
hermetically sealed with respect to ambient atmosphere throughout
steps i through iv. Some such embodiments further comprise
maintaining the substance in the storage chamber sterile or aseptic
throughout steps i through iv.
[0025] One advantage of the present invention is that the multiple
dose device, such as the multiple dose vial, can safely dispense
multiple doses of a medicament or other substance without risk of
contaminating the substance remaining within the storage chamber
after one or more doses are withdrawn, or without the risk of
cross-contamination between patients treated with medicament or
other substance from the same device. Yet another advantage is that
the one-way valve can substantially prevent air and germs from
passing through the one-way valve and into the storage chamber,
such as during dispensing multiple doses of substance from the
storage chamber into a syringe or other delivery device. Yet
another advantage is that the device can maintain the substance
stored in the storage chamber, such as a medicament,
pharmaceutical, vaccine, liquid nutrition product or supplement,
sealed with respect to ambient atmosphere and sterile and/or
aseptic through dispensing of multiple doses from the device. Yet
another advantage is that the device can allow for needleless
transfer of doses of substance, such as a medicament, from the
device to a syringe, such as through a Luer connection. Yet another
advantage is that the device can substantially prevent any ambient
or otherwise contaminated air from being injected into the chamber
of the device containing the remaining doses of substance to be
dispensed.
[0026] Other objects and advantages of the present invention,
and/or of the currently preferred embodiments thereof, will become
more readily apparent in view of the following detailed description
of currently preferred embodiments and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 is a perspective view of a multiple dose vial;
[0028] FIG. 2A is an exploded, perspective view of the
variable-volume storage chamber, closure and one-way valve of the
multiple dose vial of FIG. 1;
[0029] FIG. 2B is a perspective view of the assembled
variable-volume storage chamber, closure and one-way valve, and
illustrating the manner in which the assembly is inserted into the
body of the multiple dose vial of FIG. 1;
[0030] FIG. 3 is a cross-sectional view of the multiple dose vial
of FIG. 1 and a syringe connectable to the one-way valve for
withdrawing one or more doses of the stored substance from the
variable-volume storage chamber of the vial;
[0031] FIG. 4 is an enlarged, partial cross-sectional view of the
upper portion of the multiple dose vial of FIG. 1 illustrating the
one-way valve in the first or normally-closed position, and an
enlarged cross-sectional view of the tip of a syringe prior to
connection to the vial;
[0032] FIG. 5 is the same view as FIG. 4 but illustrating the
female Luer connector of the syringe placed into engagement with
the male Luer connector of the multiple dose vial;
[0033] FIG. 6 is the same view as FIGS. 4 and 5, but illustrating
the female Luer connector of the syringe fully engaged with the
male Luer connector of the multiple dose vial, and the one-way
valve in the second position allowing one or more doses of the
stored substance to be withdrawn from the storage chamber, through
the one-way valve, and into the body of the syringe;
[0034] FIG. 7 is an enlarged, partial cross-sectional view of the
upper portion of a multiple dose vial, illustrating the one-way
valve in the second position where the connector defines a tapered
interior surface;
[0035] FIG. 8 is a perspective view of another embodiment of a
multiple dose vial including a sliding seal received within the
vial body, spaced relative to the one-way valve, and defining the
variable-volume storage chamber between the sliding seal and the
one-way valve;
[0036] FIG. 9 is an exploded, perspective view of the vial body and
the sliding seal of the multiple dose vial of FIG. 8;
[0037] FIG. 10 is a cross-sectional view of the multiple dose vial
of FIG. 8 with the sliding seal in an empty storage chamber;
[0038] FIG. 11 is an exploded, perspective view of another
embodiment of a multiple dose vial including a flexible bladder
received within the vial body, and defining the variable-volume
storage chamber between the flexible bladder wall and the side wall
of the vial body;
[0039] FIG. 12A is a top perspective view of the multiple dose vial
of FIG. 11, wherein the bladder is in a fully expanded state and
the variable-volume storage chamber is empty;
[0040] FIG. 12B is a top perspective view of multiple dose vial of
FIG. 11, wherein the variable-volume storage chamber is partially
filled and the flexible bladder is partially collapsed;
[0041] FIG. 13A is a side view of the multiple dose vial of FIG.
11, wherein the flexible bladder is fully expanded and the
variable-volume storage chamber is empty;
[0042] FIG. 13B is a side view of the multiple dose vial of FIG.
11, wherein the variable-volume storage chamber is filled and the
flexible bladder is collapsed;
[0043] FIG. 14 is a partial top perspective view of another
embodiment of a multiple dose vial, wherein the body is a flexible
and collapsible pouch including an inlet filling port and an outlet
connector, and also showing a flexible tube connectable to the
connector for withdrawing one or more doses of the stored substance
from the variable-volume storage chamber of the pouch;
[0044] FIG. 15 is an enlarged partial top perspective view of the
multiple dose vial of FIG. 14, illustrating the connector of the
flexible tube fully engaged with the connector of the multiple dose
vial, allowing one or more doses of the stored substance to be
withdrawn from the storage chamber; and
[0045] FIG. 16 is a side view of the multiple dose vial of FIG. 14
in an upside-down position, such as for hanging, illustrating the
connector of the flexible tube fully engaged with the connector of
the multiple dose vial and a pump operatively connected to the tube
for creating a pressure differential greater than the valve opening
pressure across the one-way valve.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0046] In FIGS. 1-6, a device is indicated generally by the
reference numeral 10. In the illustrated embodiment, the device 10
is a multiple dose vial. However, as may be recognized by those of
ordinary skill in the pertinent art based on the teachings herein,
the invention is applicable to any of numerous other devices or
methods that are currently known, or that later become known. The
vial 10 comprises a body 12 and a storage chamber 14 within the
body for storing multiple doses of the substance therein. In the
illustrated embodiment, the storage chamber is a variable-volume
storage chamber defined by a flexible and/or elastic pouch 16. A
one-way valve 18 is connectable in fluid communication with a
syringe 20 (FIGS. 3-6). The one-way valve 18 (i) permits substance
from the storage chamber 14 to flow therethrough and into the
syringe 20 when connected in fluid communication therewith, and
(ii) substantially prevents any fluid flow in a substantially
opposite direction therethrough and into the storage chamber 14 to
thereby maintain the substance sterile, aseptic and/or
contamination free.
[0047] The body 12 defines a side wall 22 (here cylindrical but can
be another shape), an opening 24 at the base of the side wall, and
an upper wall 26 enclosing the body 12 at the opposite end of the
base. The upper wall 26 defines a filling port 28 extending through
a central region thereof, and a connector 30 including a male Luer
connector 32 formed on the outer end thereof, an approximately
dome-shaped base 34 extending between the male Luer connector 32
and the upper wall 26, and a valve opening 36 extending through the
connector for receiving the one-way valve 18.
[0048] As shown best in FIGS. 2A and 2B, the vial 10 includes a
variable-volume storage chamber, closure and one-way valve
preassembly 38 that is received within and fixedly secured to the
vial body 12 to form the multiple dose vial. The preassembly 38
comprises a closure 40 including a relatively rigid closure base 42
and a relatively flexible closure overlay 44 mounted on the closure
base 42. The flexible closure overlay 44 defines a flexible base
and sealing member 46, a penetrable filling portion or septum 48, a
valve cover or member 50 of the one-way valve 18, and an
approximately dome-shaped spring 52 extending between the valve
member 50 and flexible base 46. As can be seen, when the
preassembly 38 is assembled to the vial body 12, the valve cover 50
is received within the valve opening 36 of the connector 30, and
the dome-shaped spring 52 is received within the dome-shaped base
34 of the connector 30.
[0049] As shown in FIGS. 2A and 3-6, the closure base 42 defines a
filling inlet 54 that is aligned, e.g., axially, with the filling
port 28 of the vial body 12 and opens into the variable- volume
storage chamber 14 of the flexible pouch 16. As can be seen, the
flexible pouch 16 and filling inlet 54 are integrally formed with
the closure base 42. In the illustrated embodiment, the closure
base 42, filling inlet 54, and a preform (not shown) for the
flexible pouch 16 are injection molded, and the pouch 16 is, in
turn, blow molded from the injection molded preform, in accordance
with the teachings of any of the following co-pending 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. 12/577,126, filed Oct. 9, 2009,
entitled "Device with Co-Extruded Body and Flexible Inner Bladder
and Related Apparatus and Method," which claims the benefit of
similarly titled U.S. Provisional Application No. 61/104,613, filed
Oct. 10, 2008; and U.S. patent application Ser. No. 12/901,420,
filed Oct. 8, 2010, entitled "Device with Co-Molded Closure, One
Way Valve and Variable-Volume Storage Chamber, and Related Method,"
which claims the benefit of similarly titled U.S. Provisional
Application No. 61/250,363, filed Oct. 9, 2009.
[0050] As shown in FIG. 2A, the closure base 42 defines a
circular-shaped recess 56 that receives therein the flexible base
and sealing member 46 of the closure overlay 44. The closure base
42 further defines an annular seal channel 58 spaced radially
inwardly relative to the periphery of the circular-shaped recess
56. The flexible closure overlay 44 defines a corresponding
peripheral seal 60 and an annular seal 62 spaced radially inwardly
relative to the peripheral seal 60 and projecting axially
therefrom. The annular seal 62 of the closure overlay 44 is
received within the annular seal channel 58 of the closure base 42
to form a fluid-tight seal therebetween, and the peripheral seal 60
of the closure overlay 44 is received within the periphery of the
recess 56 of the closure base 42 to form a fluid-tight seal
therebetween. The closure base 42 further defines within the
circular-shaped recess 56 a valve-receiving recess 64 aligned with
the one-way valve 18, and a fluid-flow channel 66 extending between
the storage chamber port 54 and the valve-receiving recess 64. As
described further below, when the syringe 20 is fully connected to
the connector 30, the one-way valve 18 is moveable from a first
normally-closed position (FIG. 5) to a second position (FIG. 6)
which, in turn, allows fluid to be withdrawn by the syringe 20 from
the variable-volume storage chamber 14, through the storage chamber
port 54, fluid flow channel 66, and one-way valve 18 and, in turn,
into the syringe 20. As shown best in FIGS. 4-6, the vial body 12
defines a snap-fit protuberance 68 that is axially spaced adjacent
to the upper wall 26 and extends annularly about the vial body. As
can be seen, the side of the protuberance 68 opposite the upper
wall 26 is tapered inwardly to allow the closure 40 to slide past
the protuberance and into the assembled position as shown. The
protuberance 68 engages the underside of the closure base 42 to
form a compression seal between peripheral seal 60 and annular seal
62 of the flexible overlay 44 and the closure base 42, hermetically
seal the variable-volume storage chamber 14 with respect to ambient
atmosphere, and fixedly secure the closure base 42 and thus the
preassembly 38 within the vial body 12. As should be understood by
those of ordinary skill in the pertinent art, the components of the
vial may take any of numerous different shapes and/or
configurations capable of performing the function(s) of each such
component as described herein.
[0051] The septum 48 is penetrable by a needle, filling or
injection member (not shown) for sterile or aseptically filling the
storage chamber 14 with multiple doses of the substance to be
dispensed. The septum 48, in some embodiments, is formed of a
material that is sufficiently elastic to close itself after
withdrawal of the needle, filling or injection member therefrom to
thereby ensure that the head loss left by a residual penetration
hole after the injection member is withdrawn prevents fluid ingress
therethrough. Although such a septum 48 is self-closing, the septum
may be resealed by a liquid sealant such as silicone or a
silicone-based sealant, and/or the application of radiation or
energy thereto to hermetically seal the substance within the
storage chamber 14 from the ambient atmosphere and thereby maintain
the sterility of the substance.
[0052] For example, the septum 48 may be penetrable for sterile
filling the variable-volume storage chamber 14 and resealable, such
as by the application of laser, other radiation, or thermal energy,
to hermetically seal the filled substance within the storage
chamber 14 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. 12/254,789, filed Oct.
20, 2008, entitled "Container Having a Closure and Removable
Resealable Stopper for Sealing a Substance Therein and Related
Method," which, in turn, claims the benefit of U.S. patent
application Ser. No. 60/981,107, filed Oct. 18, 2007, entitled
"Container Having a Closure and Removable Resealable Stopper for
Sealing a Substance Therein;" U.S. patent application Ser. No.
12/245,678, filed Oct. 3, 2008, entitled "Apparatus For Formulating
and Aseptically Filling Liquid Products," and U.S. patent
application Ser. No. 12/245,681, filed Oct. 3, 2008, entitled
"Method For Formulating and Aseptically Filling Liquid Products,"
which, in turn, claim the benefit of U.S. patent application Ser.
No. 60/997,675, filed Oct. 4, 2007, entitled "Apparatus and Method
for Formulating and Aseptically Filling Liquid Products;" U.S.
patent application Ser. No. 12/875,440, filed Sep. 3, 2010,
entitled "Device with Needle Penetrable and Laser Resealable
Portion and Related Method," now U.S. Pat. No. 7,980,276, which is
a divisional of U.S. patent application Ser. No. 12/371,386, filed
Feb. 13, 2009, entitled "Device with Needle Penetrable and Laser
Resealable Portion," now U.S. Pat. No. 7,810,529, which is a
continuation of U.S. patent application Ser. No. 11/949,087, filed
Dec. 3, 2007, entitled "Device with Needle Penetrable and Laser
Resealable Portion and Related Method," now U.S. Pat. No.
7,490,639, which is a continuation of similarly titled U.S. patent
application Ser. No. 11/879,485, filed Jul. 16, 2007, now U.S. Pat.
No. 7,445,033, which is a continuation of similarly titled U.S.
patent application Ser. No. 11/408,704, filed April 21, 2006, now
U.S. Pat. No. 7,243,689, which is a continuation of 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," now U.S. Pat. No. 7,032,631, which is
a continuation-in-part of similarly titled U.S. patent application
Ser. No. 10/694,364, filed Oct. 27, 2003, now U.S. Pat. No.
6,805,170 which is a continuation of similarly titled U.S. patent
application Ser. No. 10/393,966, filed Mar. 21, 2003, now U.S. Pat.
No. 6,684,916, which is a divisional of similarly titled U.S.
patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now
U.S. Pat. No. 6,604,561, which, in turn, claims the benefit of
similarly titled U.S. Provisional Patent Application No.
60/182,139, filed Feb. 11, 2000, and 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; U.S. patent application Ser. No.
13/193,662, filed Jul. 29, 2011, entitled "Sealed Contained and
Method of Filling and Resealing Same," which is a continuation of
U.S. patent application Ser. No. 12/791,629, filed Jun. 1, 2010,
entitled "Sealed Containers and Methods of Making and Filling
Same," now U.S. Pat. No. 7,992,597, which is a divisional of U.S.
patent application Ser. No. 11/515,162, filed Sep. 1, 2006,
entitled "Sealed Containers and Methods of Making and Filling
Same," now U.S. Pat. No. 7,726,352, which is a continuation of U.S.
patent application Ser. No. 10/655,455, filed Sep. 3, 2003,
entitled "Sealed Containers and Methods of Making and Filling
Same," now U.S. Pat. No. 7,100,646, which is a continuation-in-part
of U.S. patent application Ser. No. 10/393,966, filed Mar. 21,
2003, entitled "Medicament Vial Having A Heat-Sealable Cap, and
Apparatus and Method For Filling The Vial," now U.S. Pat. No.
6,684,916, which is a divisional of similarly titled U.S. patent
application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat.
No. 6,604,561, which, in turn, claims the benefit of similarly
titled U.S. Provisional Patent Application No. 60/182,139, filed on
Feb. 11, 2000, and U.S. Provisional Patent Application No.
60/408,068, filed Sep. 3, 2002, entitled "Sealed Containers and
Methods Of Making and Filling Same;" U.S. patent application Ser.
No. 12/627,655, filed Nov. 30, 2009, entitled "Adjustable Needle
Filling and Laser Sealing Apparatus and Method," now U.S. Pat. No.
8,096,333, which is a continuation of similarly titled U.S. patent
application Ser. No. 10/983,178, filed Nov. 5, 2004, now U.S. Pat.
No. 7,628,184, which, in turn, claims the benefit of U.S.
Provisional Patent Application No. 60/518,267, filed Nov. 7, 2003,
entitled "Needle Filling and Laser Sealing Station," and similarly
titled U.S. Provisional Patent Application No. 60/518,685, filed
Nov. 10, 2003; U.S. patent application Ser. No. 11/901,467, filed
Sep. 17, 2007 entitled "Apparatus and Method for Needle Filling and
Laser Resealing," which is a continuation of similarly titled U.S.
patent application Ser. No. 11/510,961 filed Aug. 28, 2006, now
U.S. Pat. No. 7,270,158, which is a continuation of similarly
titled U.S. patent application Ser. No. 11/070,440, filed Mar. 2,
2005; now U.S. Pat. No. 7,096,896, which, in turn, claims the
benefit of U.S. Provisional Patent Application No. 60/550,805,
filed Mar. 5, 2004, entitled "Apparatus for Needle Filling and
Laser Resealing;" U.S. patent application Ser. No. 12/768,885,
filed Apr. 28, 2010, entitled "Apparatus for Molding and Assembling
Containers with Stoppers and Filling Same," now U.S. Pat. No.
7,975,453, which is a continuation of similarly titled U.S. patent
application Ser. No. 11/074,513, filed Mar. 7, 2005, now U.S. Pat.
No. 7,707,807, which claims the benefit of U.S. Provisional Patent
Application No. 60/551,565, filed Mar. 8, 2004, entitled "Apparatus
and Method For Molding and Assembling Containers With Stoppers and
Filling Same;" U.S. patent application Ser. No. 13/396,053, filed
Feb. 14, 2012, entitled "Method for Molding and Assembling
Containers with Stopper and Filling Same," which is a continuation
of similarly titled U.S. patent application Ser. No. 12/715,821,
filed Mar. 2, 2010, now U.S. Pat. No. 8,112,972, which is a
continuation of similarly titled U.S. patent application Ser. No.
11/074,454, filed Mar. 7, 2005, now U.S. Pat. No. 7,669,390; U.S.
patent application Ser. No. 11/339,966, filed Jan. 25, 2006,
entitled "Container Closure With Overlying Needle Penetrable and
Thermally Resealable Portion and Underlying Portion Compatible With
Fat Containing Liquid Product, and Related Method," now U.S. Pat.
No. 7,954,521, which, in turn, claims the benefit of U.S.
Provisional Patent Application No. 60/647,049, filed Jan. 25, 2005,
entitled "Container with Needle Penetrable and Thermally Resealable
Stopper, Snap-Ring, and Cap for Securing Stopper;" U.S. patent
application Ser. No. 12/861,354, filed Aug. 23, 2010, entitled
"Ready To Drink Container With Nipple and Needle Penetrable and
Laser Resealable Portion, and Related Method;" which is a
divisional of similarly titled U.S. patent application Ser. No.
11/786,206, filed Apr. 10, 2007, now U.S. Pat. No. 7,780,023,
which, into turn, claims the benefit of similarly titled U.S.
Provisional Patent Application No. 60/790,684, filed Apr. 10, 2006;
U.S. patent application Ser. No. 11/295,251, filed Dec. 5, 2005,
entitled "One-Way Valve, Apparatus and Method of Using the Valve,"
now U.S. Pat. No. 7,322,491, which, in turn, claims the benefit of
similarly titled U.S. Provisional Patent Application No.
60/644,130, filed Jan. 14, 2005, and similarly titled U.S.
Provisional Patent Application No. 60/633,332, filed Dec. 4, 2004;
U.S. patent application Ser. No. 12/789,565, filed May 28, 2010,
entitled "Resealable Containers and Methods of Making, Filling and
Resealing the Same," which is a continuation of U.S. patent
application Ser. No. 11/933,272, filed Oct. 31, 2007, entitled
"Resealable Containers and Assemblies for Filling and Resealing
Same," now U.S. Pat. No. 7,726,357, which is a continuation of U.S.
patent application Ser. No. 11/515,162, filed Sep. 1, 2006,
entitled "Sealed Containers and Methods of Making and Filling
Same," now U.S. Patent No. 7,726,352; U.S. patent application Ser.
No. 13/045,655, filed Mar. 11, 2011, entitled "Sterile Filling
Machine Having Filling Station and E-Beam Chamber," which is a
continuation of U.S. patent application Ser. No. 12/496,985, filed
Jul. 2, 2009, entitled "Sterile Filling Machine Having Needle
Filling Station and Conveyor," now U.S. Pat. No. 7,905,257, which
is a continuation of U.S. patent application Ser. No. 11/527,775,
filed Sep. 25, 2006, entitled "Sterile Filling Machine Having
Needle Filling Station within E-Beam Chamber," now U.S. Pat. No.
7,556,066, which is a continuation of similarly titled U.S. patent
application Ser. No. 11/103,803, filed Apr. 11, 2005, now U.S. Pat.
No. 7,111,649, which is a continuation of similarly titled U.S.
patent application Ser. No. 10/600,525, filed Jun. 19, 2003, now
U.S. Pat. No. 6,929,040, which, in turn, claims the benefit of
similarly-titled U.S. Provisional Patent Application No.
60/390,212, filed Jun. 19, 2002; U.S. patent application Ser. No.
13/326,177, filed Dec. 14, 2011, entitled "Device with Penetrable
and Resealable Portion and Related Method," which is a continuation
of similarly titled U.S. patent application Ser. No. 13/170,613,
filed Jun. 28, 2011, now U.S. Pat. No. 8,347,923, which is a
continuation of U.S. patent application Ser. No. 12/401,567, filed
Mar. 10, 2009, entitled "Device with Needle Penetrable and Laser
Resealable Portion and Related Method," now U.S. Pat. No.
7,967,034, which is a continuation of similarly titled U.S. patent
application Ser. No. 11/933,300, filed Oct. 31, 2007, now U.S. Pat.
No. 7,500,498; U.S. patent application Ser. No. 13/329,483, filed
Apr. 30, 2011, entitled "Ready to Feed Container," which is a
continuation of International Application No. PCT/US2011/034703,
filed Apr. 30, 2011, entitled "Ready to Feed Container and Method,"
which, in turn, claims the benefit of U.S. Provisional Patent
Application No. 61/330,263 filed Apr. 30, 2010; and U.S.
Provisional Patent Application No. 61/476,523, filed Apr. 18, 2011,
entitled "Filling Needle and Method."
[0053] Alternatively, the septum 48 may be penetrable for sterile
filling the variable-volume storage chamber 14 and resealable with
a liquid sealant, such as a silicone sealant, to hermetically seal
the filled substance within the storage chamber 14, in accordance
with the teachings of any of the following 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. 12/577,126, filed Oct. 9, 2009, entitled "Device with
Co-Extruded Body and Flexible Inner Bladder and Related Apparatus
and Method," which claims the benefit of similarly titled U.S.
Provisional Patent Application No. 61/104,613, filed Oct. 10, 2008;
U.S. patent application Ser. No. 12/901,420, filed Oct. 8, 2010,
entitled "Device with Co-Molded One-Way Valve and Variable Volume
Storage Chamber and Related Method," which claims the benefit of
similarly titled U.S. Provisional Patent Application No.
61/250,363, filed Oct. 9, 2009; and U.S. Provisional Patent
Application No. 61/476,523, filed Apr. 18, 2011, entitled "Filling
Needle and Method."
[0054] Prior to filling the variable-volume storage chamber 14, the
sealed empty chamber may be sterilized by injecting a fluid
sterilant therein, such as nitric oxide, with a needle, filling, or
injection member through the penetrable and resealable portion 48,
and the needle employed for injecting the fluid sterilant and/or
the substance to be sterile filled into the variable-volume storage
chamber 14 may be a self-opening and closing needle, in accordance
with the teachings of any of the following co-pending 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. 13/450,306, filed Apr. 18, 2012,
entitled "Needle with Closure and Method," which claims the benefit
of U.S. Provisional Patent Application No. 61/476,523, filed Apr.
18, 2011, entitled "Filling Needle and Method;" and U.S. patent
application Ser. No. 13/529,951, filed Jun. 21, 2012, entitled
"Fluid Sterilant Injection Sterilization Device and Method," which
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." As may be recognized by those of
ordinary skill in the pertinent art based on the teachings herein,
the penetrable and resealable portion or septum may be penetrated
and resealed, and the variable-volume storage chamber may be
sterilized and sterile filled, by any of numerous different devices
and methods that are currently known, or that later become
known.
[0055] As shown best in FIGS. 4-6, the one-way valve 18 includes a
relatively rigid valve seat 70 that is received within the flexible
valve member or cover 50 and defines a normally closed, valve seam
72 therebetween. In the illustrated embodiment the valve seam 72 is
axially-elongated and annular, but can have other shapes and
configurations. The valve member 50 engages, and in some
embodiments forms an interference fit with, the valve seat 70 to
thereby form a fluid-tight seal in the normally closed position
and, in turn, maintain the substance within the storage chamber 14
in a sterile and hermetically sealed condition. The valve 18
defines a valve opening pressure and remains in the normally closed
position unless a pressure differential across the valve exceeds
the valve opening pressure. When a pressure differential across the
valve does exceed the valve opening pressure, the valve member 50
expands, e.g., radially, relative to or otherwise moves away from
the valve seat 70 and opens the valve seam 72 therebetween.
[0056] The valve opening pressure is defined, in part, as a
function of the length of the engagement of the valve member 50
with the valve seat 70, i.e., the axial extent of the valve seam
72. The greater the length thereof, the greater the valve opening
pressure. As shown, the valve seat 70 defines at least one
elongated groove 71 therein. Thus, the valve member 50 need not be
displaced at the groove(s) 71 for the fluid to flow. Accordingly,
the length, and number, of the groove(s) 71 effectively reduces the
length of the valve seam 72 and thus effectively reduces the valve
opening pressure of the valve 18. The length and number of the
groove(s) 71 are configured, in consideration of the properties of
the valve member 50, e.g., its elasticity, thickness, shape, etc.,
such that a delivery device engaging the valve 18 and utilized in a
normal manner, e.g., withdrawing a plunger from a barrel of a
syringe engaging the valve, is capable of creating a pressure
differential across the valve that exceeds the valve opening
pressure, and this opens the valve seam 72. Conversely, these
features are configured to maintain a minimum valve opening
pressure to prevent unintentional opening, as should be understood
by one of ordinary skill in the pertinent art.
[0057] In some embodiments, such as seen in FIGS. 7 and 10, the
valve member 50', 150 may also define a substantially tapered
cross-sectional shape moving in the direction from an inlet towards
an outlet of the valve. This configuration requires progressively
less energy to open the valve when moving from the interior, or
inlet, toward the exterior, or outlet, of the valve. Alternatively,
or in combination with the tapered valve member 50', 150, the valve
seat 70', 170 may define an outer diameter that progressively or
otherwise increases in the direction from the inlet towards the
outlet of the valve, to provide the same or similar effect. As a
result, once the pressure is sufficient to open the valve at an
inlet thereof, the pressure is sufficient to cause the downstream
segments or portions of the valve member 50', 150 to progressively
open and then close after passage of substance through the
respective portion of the valve seam 72', 172 when moving in the
direction from the inlet towards the outlet of the valve to
dispense the dosage of substance. Also, in some embodiments, at any
time when dispensing a dosage of substance, at least one of the
plurality of segments of the valve member 50 engages the valve seat
70 to maintain a fluid-tight seal across the valve 18, and thereby
prevent ingress of fluid, germs, bacteria or other unwanted
substances therethrough and into the variable-volume storage
chamber 14.
[0058] As indicated above, the valve 18 includes a substantially
dome-shaped spring 52 formed of a resilient and/or elastomeric
material. The spring 52 permits the valve member 18 to move between
an extended first position (FIG. 5), wherein the valve member 50 is
fully received within the valve opening 36 of the connector, and a
depressed second position (FIG. 6) wherein the valve member 50 is
depressed or otherwise moved distally within the valve opening 36
and out of engagement with the interior surface 74 of the connector
30. As can be seen, the dome-shaped spring 52 normally biases the
valve 18 in the direction from the second position toward the first
position. The spring 52 also substantially prevents pressure
created by inadvertently ejected air or other material from a
syringe or other delivery device 20 connected to the valve 18 from
moving the valve from the first position toward the second
position.
[0059] When in the first position (FIG. 5), the interior surface 74
forming the valve opening 36 engages the valve member 50 or
otherwise substantially prevents expansion or opening of the valve
member 50 relative to the valve seat 70, and thus prevents the
valve 18 from opening. The valve seam 72 is closed, thereby
preventing the passage of the substance therethrough. When in the
second position (FIG. 6), on the other hand, the valve member 50 is
disengaged from the interior surface 74 with sufficient space
around it so that the valve 18 is free to open (and open the valve
seam 72) when a pressure differential across the valve 18 exceeds
the valve opening pressure to, in turn, permit expansion of the
valve member 50 relative to the valve seat 70 and thereby allow the
flow of substance from the variable-volume storage chamber
therethrough.
[0060] The flexible valve member 50 defines a base portion 76 that
engages a distal base of the valve seat 70 to support the valve
seat, e.g., axially, within the valve 18. The base portion 76
defines one or more valve inlet apertures 78 therethrough, in fluid
communication with the normally closed valve seam 72, to permit
fluid flow from the variable-volume storage chamber 14 and through
the valve seam 72, when the valve 18 is in the second position and
the pressure differential across the valve exceeds the valve
opening pressure. The outlet end of the valve seat 70 defines a
plurality of angularly spaced protuberances 79 thereon that engage
a syringe connector 84 of the syringe 20 and permit the flow of
fluid therebetween (between the protuberances 79) in order to allow
fluid flow through the valve 18 and into the syringe 20.
[0061] In order to dispense the substance from the vial 10, the
syringe or other delivery device 20 is connected to the connector
30. As shown in FIG. 3, the syringe 20 includes a barrel 80, a
manually-engageable plunger 82 received within the barrel, and the
connector 84 mounted at one end of the barrel and in fluid
communication with the interior of the barrel. In the illustrated
embodiment, the vial connector 30 is a male Luer connector, and the
syringe connector 84 is a female Luer connector. However, as may be
recognized by those of ordinary skill in the pertinent art based on
the teachings herein, any of numerous different connectors for
either the syringe or other delivery device, or the multiple dose
vial or other device, that are currently known, or that later
become known, may be used.
[0062] When connected to the vial 10, as shown, for example, in
FIGS. 5 and 6, the connector 84 of the syringe 20 engages the valve
seat 70 and displaces the valve 18 from the first position toward
the second position. When in the second position, the connector 30
and the valve 18 define a cavity 75 therebetween. Thus, if the
plunger 82 of the syringe 20 is mistakenly depressed further into
barrel of the syringe 20, thereby ejecting air (or other
substances) therefrom, the valve 18 remains closed and the ejected
material does not flow therethrough, but rather enters into the
cavity 75 surrounding the valve 18. The pressure of the air in the
cavity 75 functions to further compress the flexible valve member
50 onto the valve seat 70, i.e., helping to keep the valve 18
closed, thereby further ensuring no entry of material through the
valve 18 and into the storage chamber 14. In some embodiments, such
as shown in FIG. 7, the interior surface 74' of the connector 30'
defines a substantially tapered cross-sectional shape moving in the
direction from the dome shaped base 34' toward the Luer connector
32', thereby requiring relatively less movement (compared to
embodiments where the interior surface 74' is not tapered) of the
valve 18' in the direction from the first position toward the
section position in order to disengage the interior surface 74'
from the valve member 50'. Thus, the cavity 75' is larger in or to
accommodate a greater volume of inadvertently ejected air, and
further compress the valve 18'. The taper is also sufficient so
that the valve member 50' can move away from the valve seat 70' and
open the valve 18'.
[0063] Conversely, when in the second position and upon withdrawal
of the plunger 82 of the syringe 20, a vacuum or partial vacuum is
created within the barrel of the syringe 20 which, in turn, creates
a pressure differential across the valve 18. When the pressure
differential across the valve 18 exceeds the valve opening
pressure, the valve seam 72 opens, and the substance within the
variable-volume storage chamber 14 flows through the valve inlet
aperture(s) 78 and, in turn, through the valve seam 72 and into the
barrel of the syringe. Because the valve 18 is in the second
position, the valve member 50 is permitted to move relative to the
valve seat 70, e.g., radially, to allow the flow of the substance
from the variable-volume storage chamber therethrough and into the
syringe. However, because of the nature of the valve member 50, any
ambient air or other fluid that could contaminate the interior of
the valve or storage chamber is substantially prevented from
flowing through the valve in the opposite direction, as discussed
above. As a result, the interior of the valve and storage chamber
can be maintained sterile, aseptic, and/or contamination free, as
desired, throughout dispensing of dosages from the storage chamber.
When withdrawal of the syringe plunger 82 is terminated, the
pressure differential, if any, across the valve 18 decreases to
than the valve opening pressure, the valve seam 72 closes (the
valve member 50 moves back into engagement with the valve seat 70)
and the flow of substance from the variable-volume storage chamber
14 through the valve 18 is terminated.
[0064] Upon disconnection, e.g., unscrewing, of the syringe
connector 84 from the vial connector 30, the dome-shaped spring 52
drives the valve from the second position toward the first position
where the interior surface 74 of the connector engages the valve
member 50 and further prevents the possibility of the valve seam 72
opening and any fluid flow through the valve. In embodiments as in
FIG. 7 where the interior surface 74' is tapered, the taper assists
in guiding the valve 18 into the first position. Thus, the valve 18
permits substance from the variable-volume storage chamber 14 to
flow through the one-way valve and into the delivery device
connected in fluid communication therewith, but prevents the
ingress of fluid in a substantially opposite direction into the
variable-volume storage chamber. Consequently, the substance within
the variable-volume storage chamber 14 is never exposed to the
ambient atmosphere. When another dose of substance is needed from
the vial, the same steps may be repeated.
[0065] In FIGS. 8-10, another device is indicated generally by the
reference numeral 110. The device 110 is substantially similar to
the devices 10, 10' described above in connection with FIGS. 1-7,
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 that a sliding seal or
stopper 186 is received within the vial body 112 and is spaced
relative to the one-way valve 118, wherein the variable-volume
storage chamber 114 is defined between the sliding seal 186 and the
one-way valve 118, as hereinafter described.
[0066] The sliding seal 186 includes at least one, and in the
embodiment shown, best seen in FIG. 9, two axially spaced outer
annular sealing members or portions 187 that sealingly engage the
interior cylindrical wall of the vial body 112 to form a
fluid-tight seal therebetween, but permit the sliding stopper to
slide within the vial body. The sealing members or portions 187 may
be formed integral with the sliding seal 186, such as by forming
thereon annular protuberances, as shown, or may be formed by
sealing members, such as o-rings or other sealing members, that are
received within corresponding grooves or recesses formed in the
sliding seal. A removable base closure 188 encloses the opening 124
at the base of the vial body 112, and includes one or more vent
apertures 189 to prevent the formation of a vacuum between the
sliding seal 186 and the base closure 188, and otherwise to allow
the sliding seal 186 to travel through the vial body 112 upon
dispensing of the substance from the vial 110, as described further
below.
[0067] The sliding seal 186 and the manner in which it cooperates
with the vial body 112 to define the variable-volume storage
chamber 114 may be the same as or substantially similar to that
disclosed in 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. 13/219,597, filed Aug. 26, 2011, entitled
"Laterally-Actuated Dispenser with One-Way Valve For Storing and
Dispensing Substances," which is a continuation of U.S. patent
application Ser. No. 12/710,516, filed Feb. 23, 2010, entitled
"Laterally-Actuated Dispenser with One-Way Valve for Storing and
Dispensing Metered Amounts of Substances," now U.S. Pat. No.
8,007,193, which is a continuation of similarly titled U.S. patent
application Ser. No. 11/237,599, filed Sep. 27, 2005, now U.S. Pat.
No. 7,665,923, which, in turn, claims the benefit of similarly
titled U.S. Provisional Patent Application No. 60/613,583, filed
Sep. 27, 2004, and similarly titled U.S. Provisional Application
No. 60/699,607 filed Jul. 15, 2005; and U.S. patent application
Ser. No. 13/743,661, filed Jan. 17, 2013, entitled "Multiple Dose
Syringe and Method," which, in turn, claims the benefit of
similarly titled U.S. Provisional Patent Application No.
61/587,500, filed Jan. 17, 2012.
[0068] In the illustrated embodiment, the closure 140, including
the closure base 142, is integrally formed with the upper side of
the vial body 112, and the flexible closure overlay 144 is mounted
thereon in the same manner as in the embodiments described above in
connection with FIGS. 1-7. A vial cap 127, defining the upper wall
126 and connector 130, mounts atop the closure overlay 144 to
sealingly enclose the body 112 at the upper side of the vial 110.
The vial cap 127 further defines the snap-fit protuberance 168 that
is axially spaced adjacent to the upper wall 126 and extends
annularly about the cap 127. The side of the protuberance 168
opposite the upper wall 126 is tapered inwardly to allow the
closure base 142 of the vial body 112 to slide over the
protuberance and snap into the assembled position as shown. The
protuberance 168 engages the underside of the closure base 142 to
form a compression seal between the peripheral seal 160 and annular
seal 162 of the flexible overlay 144 and the closure base 142,
hermetically seal the variable-volume storage chamber with respect
to the ambient atmosphere, and fixedly secure the vial cap 127 onto
the vial body 112.
[0069] In the illustrated embodiment, the flexible closure overlay
144 defines the flexible base and sealing member 146, the
penetrable and resealable portion or septum 148, the valve cover or
member 150 of the one-way valve 118, and the approximately
dome-shaped spring 152. The closure base 142 defines, within the
circular-shaped recess 156, the valve-receiving recess 164 aligned,
e.g., axially, with the one-way valve 118, and at least one
fluid-flow aperture 190 within the valve-receiving recess 164.
[0070] Similar to the embodiments described above in connection
with FIGS. 1-7, the penetrable and resealable portion or septum 148
is penetrable by a needle, filling or injection member (not shown)
for sterile or aseptically filling the storage chamber 114 with
multiple doses of the substance to be dispensed. The septum 148,
can be formed of a material that is sufficiently elastic to close
itself after withdrawal of the needle, filling or injection member
therefrom to thereby ensure that the head loss left by a residual
penetration hole after the injection member is withdrawn prevents
fluid ingress therethrough. Although such a septum 148 is
self-closing, the septum may be resealed by a liquid sealant, such
as silicone or a silicone-based sealant, and/or the application of
radiation or energy thereto to hermetically seal the substance
within the storage chamber 114 from the ambient atmosphere and
thereby maintain the sterility of the substance. The septum 148 may
be penetrable for sterile filling the variable-volume storage
chamber and resealable, such as by the application of laser, other
radiation, or thermal energy, to hermetically seal the filled
substance within the storage chamber in accordance with the
teachings of any of the patents and patent applications
incorporated by reference above. Alternatively, the septum 148 may
be penetrable for sterile filling the variable-volume storage
chamber, and resealable with a liquid sealant, such as a silicone
sealant, to hermetically seal the filled substance within the
storage chamber, in accordance with the teachings of any of the
patents and patent applications incorporated by reference
above.
[0071] Prior to filling the variable-volume storage chamber, the
sealed empty chamber may be sterilized by injecting a fluid
sterilant therein, such as nitric oxide, with a needle, filling or
injection member through the penetrable and resealable portion 148,
and the needle employed for injecting the fluid sterilant and/or
the substance to be sterile filled into the variable-volume storage
chamber may be a self opening and closing needle, in accordance
with the teachings of any of the patents and patent applications
incorporated by reference above.
[0072] Similar to the embodiments described above, the one-way
valve 118 includes a relatively rigid valve seat 170 that is
received within the flexible valve member or cover 150 and defines
a normally closed, valve seam 172 therebetween. The valve member
150 engages, and in alternative embodiments forms an interference
fit with, the valve seat 170 to thereby form a fluid-tight seal in
the normally closed position and, in turn, maintain the substance
within the storage chamber 114 in a sterile and hermetically sealed
condition. The valve 118 defines a valve opening pressure, and
remains in the normally closed position unless a pressure
differential across the valve exceeds the valve opening pressure.
When a pressure differential across the valve does exceed the valve
opening pressure, the valve member 150 expands, e.g., radially,
relative to or otherwise moves away from the valve seat 170 and
opens the valve seam 172 therebetween.
[0073] The valve 118 includes a substantially dome-shaped spring
152 formed of a resilient and/or elastomeric material. Similar to
the embodiment described above, the spring 152 permits the valve
member 118 to move between an extended first position wherein the
valve member 150 is fully received within the valve opening 136 of
the connector 130, and a depressed second position wherein the
valve member 150 is depressed or otherwise moved distally within
the valve opening 136 and out of engagement with the connector 130.
As can be seen, the dome-shaped spring 152 normally biases the
valve 118 in the direction from the second position toward the
first position.
[0074] When in the first position, the interior surface 174 forming
the valve opening 136 engages the valve member 150 or otherwise
substantially prevents radial expansion or opening of the valve
member 150 relative to the valve seat 170, and thus prevents the
valve 118 from opening. The annular valve seam 172 is closed. When
in the second position, the valve member 150 is disengaged from the
connector interior surface 174 with sufficient space around it so
that the valve 118 is free to open (and open the valve seam 172)
when a pressure differential across the valve 118 exceeds the valve
opening pressure to, in turn, permit expansion of the valve member
150 relative to the valve seat 170 and thereby allow the flow of
substance from the variable-volume storage chamber
therethrough.
[0075] The flexible valve member 150 defines a base portion 176
that engages an inner end of the valve seat 170 to support the
valve seat within the valve 118. The base portion 176 defines one
or more valve inlet apertures 178 therethrough in fluid
communication with the normally closed annular valve seam 172 to
permit fluid flow from the variable-volume storage chamber 114
through the valve 118 when in the second position and the pressure
differential across the valve exceeds the valve opening pressure.
The outlet end of the valve seat 170 defines a plurality of
angularly spaced protuberances 179 thereon that engage a syringe
connector 84 of the syringe 20 but permit the flow of fluid
therebetween (between the protuberances 179) in order to allow
fluid flow through the valve 118 and into the syringe 20.
[0076] In order to dispense the substance from the vial, the
syringe or other delivery device 20 is connected to the connector
130. When connected to the vial 110, the connector 84 of the
syringe engages the valve seat 170 and displaces the valve 118 from
the first position to the second position. When in the second
position, and upon withdrawal of the plunger 82 of the syringe, a
vacuum or partial vacuum is created within the barrel of the
syringe 20 which, in turn, creates a pressure differential across
the valve 118. When the pressure differential across the valve 118
exceeds the valve opening pressure, the valve seam 172 opens and
the substance within the variable-volume storage chamber flows
through the fluid flow aperture(s) 190 and subsequently through the
valve inlet aperture(s) 178 and, in turn, through the valve seam
172 and into the barrel of the syringe 20. As substance is
dispensed from the variable-volume storage chamber 114, suction
forces exerted on the sliding seal 186 caused by the exit of the
substance from the storage chamber 114 cause the seal to move or
slide within the vial body 112 toward the one-way valve 118 to
reduce the volume of the variable-volume storage chamber 114 by
substantially the same volume of substance dispensed.
[0077] When withdrawal of the syringe plunger 82 is terminated, the
pressure differential, if any, across the valve 118 decreases to
less than the valve opening pressure, and the flow of substance
from the variable-volume storage chamber 114 through the valve 118
is terminated. Upon disconnection of the syringe connector 84 from
the vial connector 130, the dome-shaped spring 152 drives the valve
from the second position toward the first position where the
interior surface 174 of the connector engages the valve member 150
and further prevents the possibility of any fluid flow through the
valve. When another dose of substance is needed from the vial, the
same steps may be repeated. Thus, the interior of the valve and
storage chamber can be maintained sterile, aseptic, and/or
contamination free, as desired, throughout dispensing of dosages
from the storage chamber, as explained in the embodiment described
above.
[0078] In FIGS. 11-13B, another embodiment of the device is
indicated generally by the reference numeral 210. The device 210 is
substantially similar to the devices 10, 10' and 110 described
above in connection with FIGS. 8-10, and therefore like reference
numerals preceded by the numeral "2" are used to indicate like
elements. For simplicity, the following description is directed to
the differences in the variable-volume storage chamber 214 within
the vial body 212.
[0079] As shown in the illustrated embodiment of FIG. 11, the vial
210 includes a collapsible flexible bladder 291 integrally formed
with, and projecting from, a base closure 288. The base closure 288
sealingly encloses the base of the vial body 212, thereby sealing
off the storage chamber 214 from the ambient atmosphere, and the
flexible bladder 291 projects within the vial body 212 toward the
opposing valve end of the vial 210. Alternatively, in other
embodiments, the bladder 291 may extend from the closure 240 toward
the base end of the vial 210. The variable-volume storage chamber
214 is defined between the flexible bladder 291 and the side wall
222 of the vial body 212. The flexible bladder 291 has a bladder
wall 292 defining a bladder cavity 293 therein. The flexible
bladder 291 has a substantially central opening 294 at a base end
thereof, defining an open port 295 in the base closure 288 in fluid
communication with the bladder cavity 293.
[0080] In the illustrated embodiment, the base closure 288 and a
preform (not shown) for the flexible bladder 291 are injection
molded, and the bladder 291 is, in turn, blow molded from the
injection molded preform, in accordance with the teachings of any
of the patents and patent applications incorporated by reference
above. In other embodiments, the elastic bladder 291 is sealed and
is compressible and expandable.
[0081] The flexible bladder 291 is tubular in configuration and
defines an external diameter dimensioned to fit within the vial
body 212 when in the fully expanded state as shown in FIGS. 12A and
13A. However, the bladder 291 can have other configurations capable
of performing the functions of the bladder as described herein. In
the fully expanded state, as shown in FIGS. 11, 12A, 13A, the wall
292 of the bladder 291 defines a shape or morphology substantially
the same as that of the vial body side wall 222 so that it conforms
to and contacts the vial body side wall 222 throughout the
interface of these two components. In this state, the empty
variable- volume storage chamber is substantially airless.
[0082] The storage chamber 214 is sterile or aseptically filled
with multiple doses of the substance to be dispensed via the
penetrable and resealable portion or septum 248, in similar manner
as in the embodiments described above. As the storage chamber 214
is filled with the substance, the bladder 291 collapses, as shown
in FIGS. 12B and 13B and explained further below. Thereafter, when
the connector 84 of the syringe 20 engages the valve seat 270,
displaces the valve 218 from the first position to the second
position, and the plunger 82 is subsequently withdrawn, the
substance within the variable-volume storage chamber 214 flows
through the one-way valve 218 and into the barrel of the syringe
20. As each dose of substance is dispensed from the variable-volume
storage chamber 214, the bladder 291 inflates accordingly, as also
explained further below. As shown in FIGS. 12A and 13A, the bladder
291 is expandable until the bladder wall 292 substantially conforms
to the morphology of the side wall 222 of the vial body 212, to
thereby eliminate any ullage or dead space and dispense
substantially all of the substance in the storage chamber 214.
[0083] The sealed interior of the vial body 212, comprised of the
variable-volume storage chamber 214 and the flexible bladder 291,
defines a constant volume. As the volume of the storage chamber 214
increases, the volume of the flexible bladder cavity 293
substantially correspondingly decreases, and likewise, as the
volume of the storage chamber 214 decreases, the volume of the
flexible bladder cavity 293 substantially correspondingly
increases.
[0084] As shown in FIG. 11, the flexible bladder 291 is assembled
into the vial body 212 in its fully expanded state. Any air in the
vial body 212 is thus displaced out the rear of the vial body 212
during assembly. Thereafter, when the sealed variable-volume
storage chamber 214 is filled with a desired volume of substance,
i.e., when substance is filled between the side wall 222 of the
vial body 212 and the wall 292 of the flexible bladder 291, the
flexible bladder 291 collapses accordingly, where a substantially
equal volume of air flows out of the bladder cavity 293, through
the open port 295, and into the ambient atmosphere. Afterwards,
when a dose of the substance within the variable-volume storage
chamber 214 is dispensed therefrom, through the valve 218, the
pressure differential between the variable-volume storage chamber
214 and the atmosphere causes a substantially equal volume of air
to flow into the bladder cavity 293, through the port 295, and
re-expand the bladder. In some embodiments, a one-way valve is
inserted into the open port 295 of the base closure 288 after the
variable-volume storage chamber 214 is filled with the substance
and the bladder 291 is collapsed. The one-way valve allows air to
flow into the bladder cavity 293 with each dose of substance
dispensed, but substantially prevents air from flowing out of the
cavity. As may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, the one-way valve may
take the form of any of numerous different one-way valves, that are
currently known, or that later become known, for performing the
function of the one-way valve as described herein, including
without limitation a check valve, a duckbill valve, a flapper valve
or an umbrella valve.
[0085] In FIGS. 14-16, another device is indicated generally by the
reference numeral 310. The device 310 is substantially similar to
the devices 10, 10', 110 and 210 described above in connection with
FIGS. 1-13B, 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 device 10 is that
the body 312 is a collapsible bladder, bag or pouch, rather than a
rigid vial body 12, as hereinafter described.
[0086] The collapsible pouch 312 defines the variable-volume
storage chamber 314 therein. As shown best in FIGS. 14 and 15, the
collapsible pouch 312 includes a filling port 328 and an outlet
connector 330. In the illustrated embodiment, the filling port 328
and the connector 330 are both located at one end of the pouch 312.
However, as should be recognized by those of ordinary skill in the
pertinent art, the filling port and connector may equally be
located at opposing ends of the pouch 312. The filling port may
also be on the pouch 312 itself. Similar to the embodiments
described above, the filling port 328 is utilized for sterile or
aseptically filling the storage chamber 314 therethrough with
multiple doses of the substance to be dispensed, and the outlet
connector 330 is utilized for dispensing doses of substance
therefrom. With each dose of substance dispensed, the pouch 312 is
collapsible by approximately the same volume.
[0087] Similar to the above-described embodiments, the particular
filling port 328 shown includes a penetrable and resealable portion
or septum 348. The septum 348 is penetrable by a needle, filling or
injection member (not shown) for sterile or aseptically filling the
storage chamber 314 with multiple doses of the substance to be
dispensed. The septum 348, in some embodiments, is formed of a
material that is sufficiently elastic to close itself after
withdrawal of the needle, filling or injection member therefrom to
thereby ensure that the head loss left by a residual penetration
hole after the filling or injection member is withdrawn prevents
liquid ingress therethrough. Like septums 48, 48', 148, 248,
although the septum 348 is sufficiently self-closing to prevent
liquid passage, the septum may be resealed by a liquid sealant,
such as silicone or a silicone-based sealant, and/or the
application of radiation or energy thereto in order to hermetically
seal the substance within the storage chamber 314 to prevent
ingress of air or contaminants from the ambient atmosphere or
environment and thereby maintain the sterility thereof. The septum
348 may be penetrable for sterile filling the variable-volume
storage chamber and resealable, such as by the application of
radiation or energy, e.g., laser radiation or thermal energy, to
hermetically seal the filled substance within the storage chamber
in accordance with the teachings of any of the patents and patent
applications incorporated by reference above. Alternatively, the
septum 348 may be penetrable for sterile filling the
variable-volume storage chamber 314, and resealable with a liquid
sealant, such as a silicone sealant, to hermetically seal the
filled substance within the storage chamber, in accordance with the
teachings of any of the patents and patent applications
incorporated by reference above.
[0088] The outlet connector 330 includes a one-way valve 318
therein, similar in design and function to the one way valves 18,
18', 118, and 218 of the above-described embodiments, and a Luer
connector 332 formed at the outer end thereof. The one-way valve
318 is connectable in fluid communication with a syringe or other
delivery device 320 via the Luer connector 332. As described above,
the one-way valve 318 (i) permits substance from the storage
chamber 314 to flow therethrough and into the dispensing member 320
when connected in fluid communication therewith, and (ii)
substantially prevents any fluid flow in a substantially opposite
direction therethrough and into the storage chamber 314 to thereby
maintain the substance sterile, aseptic, and/or contamination
free.
[0089] The illustrated delivery device 320 includes a flexible tube
380 having a connector 384 at an inlet end thereof, and a pump 382
(FIG. 16) operatively associated with the tube 380. In order to
dispense the substance from the storage chamber 314 of the pouch
312, the connector 384 of the flexible tube 380 is connected to the
pouch outlet connector 330 (FIGS. 15, 16). In the illustrated
embodiment, the Luer connector 332 of the outlet connector 330 is a
male Luer connector, and the flexible tube connector 384 is a
female Luer connector. However, as may be recognized by those of
ordinary skill in the pertinent art based on the teachings herein,
any of numerous different connectors for either the delivery device
or the pouch that are currently known, or that later become known,
may be used.
[0090] When connected to the pouch 312, the connector 384 of the
flexible tube 380 displaces the valve 318 from the first position
to the second position, similarly to as described above with
respect to the previous embodiments. When in the second position,
operation of the pump 382 creates a pressure differential across
the valve 318 exceeding the valve opening pressure, thereby opening
the valve 318 and allowing the substance to flow from the storage
chamber 314, through the valve 318, and through the tube 380.
[0091] Similar to as described above with respect to the previous
embodiments, any ambient air or other fluid that could contaminate
the interior of the valve 318 or storage chamber 314 is
substantially prevented from flowing through the valve in the
opposite direction. As a result, the interior of the valve and
storage chamber can be maintained sterile, aseptic, and/or
contamination free, as desired, throughout dispensing of dosages
from the storage chamber. When operation of the pump 382 is
terminated, the pressure differential, if any, across the valve 318
is less than the valve opening pressure, and the flow of substance
from the variable-volume storage chamber 314 through the valve 318
is also terminated. Additionally, any substance within the flexible
tube 380, between the valve 318 and the pump 382, is sealed by the
pump 382, and prevented from flowing past it. As should be
understood by those of ordinary skill in the pertinent art based on
the teachings herein, any of numerous different pumps or actuators,
currently known or that later become known, may be utilized with
the flexible tube to draw fluid out of the storage chamber and
through the one-way valve. For example, and without limitation, a
peristaltic pump may be utilized. As another example, a syringe can
be connected to the end of the tube 380 to withdraw fluid from the
pouch 312.
[0092] 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
vial may be made of any of numerous different materials or
combinations of materials that are currently known, or that later
become known for performing the function(s) of each such component.
Similarly, the components of the vial may take any of numerous
different shapes and/or configurations, and may be manufactured in
accordance with any of numerous different methods or techniques
that are currently known, or later become known.
[0093] As another example, the penetrable and resealable portion
may be located at a different part of the vial rather than the
flexible closure overlay at the top end thereof. For example, and
without limitation, in embodiments having a sliding seal or a
flexible bladder formed with a base closure, the seal or the base
closure may include the penetrable and resealable septum,
respectively. In such a configuration, the variable-volume storage
chamber may be filled in like manner as described above, but from
the base end of a vial rather than from the opposing dispensing
valve end. One advantage of such a configuration is that a sliding
seal or base closure and flexible bladder including a penetrable
and resealable septum would define a universal bottom which may be
utilized with any vial having an open end at one end and a
dispensing port and/or valve at the opposing end. Such a setup
would require no modification to the vial. Rather, after assembling
the sliding seal or base closure and flexible bladder in sealing
engagement with the vial, it would be aseptically fillable via the
septum therein, and define a variable-volume storage chamber
resulting from the functionality of the sliding seal or the
flexible bladder.
[0094] Further, rather than sterile or aspect fill the storage
chamber with a penetrable and resealable septum, as described
above, the storage chamber may be sterile or aseptic filled through
a non-piercing filling cannula or probe that is connectable in
fluid communication with a one-way valve mounted on the vial body
or otherwise on the device, e.g., on the sliding seal or base
closure, in fluid communication with the storage chamber. For
example, the filling cannula and/or one-way valve may be
constructed 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. 12/534,730,
filed Aug. 3, 2009, entitled "Lyophilization Method and Device,"
now U.S. Pat. No. 8,272,411, which is a continuation of U.S. patent
application Ser. No. 11/487,836, filed Jul. 17, 2006, entitled
"Container with Valve Assembly and Apparatus and Method for
Filling," now U.S. Pat. No. 7,568,509, which is a continuation of
U.S. patent application Ser. No. 10/833,371, filed Apr. 28, 2004,
entitled "Container with Valve Assembly for Filling and Dispensing
Substances, and Apparatus and Method for Filling," now U.S. Pat.
No. 7,077,176, which, in turn, claims the benefit of similarly
titled U.S. Provisional Patent Application No. 60/465,992, filed
Apr. 28, 2003, and U.S. Provisional Patent Application No.
60/469,677, filed May 12, 2003, entitled "Dispenser and Apparatus
and Method for Filling a Dispenser," and similarly titled U.S.
Provisional Patent Application No. 60/471,592, filed May 19, 2003;
U.S. patent application Ser. No. 12/984,482, filed Jan. 4, 2011,
entitled "Dispenser and Apparatus and Method for Filling a
Dispenser," which is a continuation of similarly titled U.S. patent
application Ser. No. 12/025,362, filed Feb. 4, 2008, now U.S. Pat.
No. 7,861,750, which is a continuation of similarly titled U.S.
patent application Ser. No. 11/349,873, filed Feb. 8, 2006, now
U.S. Pat. No. 7,328,729, which is a continuation of
similarly-titled U.S. patent application Ser. No. 10/843,902, filed
May 12, 2004, now U.S. Pat. No. 6,997,219, which, in turn, claims
the benefit of similarly titled U.S. Provisional Patent Application
No. 60/469,677, filed May 12, 2003, and similarly titled U.S.
Provisional Patent Application No. 60/471,592, filed May 19, 2003,
and U.S. Provisional Patent Application No. 60/488,355, filed Jul.
17, 2003, entitled "Piston-Type Dispenser with One-Way Valve for
Storing and Dispensing Metered Amounts of Substances, and Pivoting
Cover for Covering Dispensing Portion Thereof," and U.S.
Provisional Patent Application No. 60/539,814, filed Jan. 27, 2004,
entitled "Piston-Type Dispenser with One-Way Valve for Storing and
Dispensing Metered Amounts of Substances;" and U.S. patent
application Ser. No. 12/724,370, filed Mar. 15, 2010, entitled
"Method for Delivering a Substance to an Eye," which is a
continuation of U.S. patent application Ser. No. 10/990,164, filed
Nov. 15, 2004, entitled "Delivery Device and Method of Delivery,"
now U.S. Pat. No. 7,678,089, which, in turn, claims the benefit of
similarly titled U.S. Provisional Patent Application No.
60/519,961, filed Nov. 14, 2003.
[0095] Alternatively, the storage chamber may be filled via a
connector. For example, a sterile or aseptic connector may be
constructed 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. Provisional Patent Application No.
61/625,663, filed Apr. 17, 2012, entitled "Self Closing Connector,"
similarly titled U.S. Provisional Patent Application No.
61/635,258, filed Apr. 18, 2012; U.S. Provisional Patent
Application No. 61/641,248, filed May 1, 2012, entitled "Device for
Connecting or Filling and Method;" and U.S. patent application Ser.
No. 13/080,537, filed Apr. 5, 2011, entitled "Aseptic Connector
with Deflectable Ring of Concern and Method," which, in turn,
claims the benefit of similarly titled U.S. Provisional Patent
Application No. 61/320,857, filed Apr. 5, 2010.
[0096] The vial or other device embodying the present invention
also may be used to store and dispense any of numerous different
types of fluids or other substances for any of numerous different
applications that are currently known, or later become known. In
addition, the storage chamber need not be a variable-volume storage
chamber. For example, in another embodiment, the storage chamber
defines a substantially fixed volume, but includes a sterile
filter, such as a micro-filter of a type known to those of ordinary
skill in the pertinent art, that is coupled in fluid communication
between the storage chamber and ambient atmosphere to allow air to
flow into the storage chamber, but that sterilizes any such air
that flows therethrough in order to maintain the interior of the
variable-volume storage chamber sterile. Accordingly, this detailed
description of embodiments is to be taken in an illustrative, as
opposed to a limiting sense.
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