U.S. patent application number 16/000172 was filed with the patent office on 2018-12-20 for device for connecting or filling and method.
The applicant listed for this patent is DR. PY INSTITUTE LLC. Invention is credited to Daniel Py.
Application Number | 20180363819 16/000172 |
Document ID | / |
Family ID | 49511833 |
Filed Date | 2018-12-20 |
United States Patent
Application |
20180363819 |
Kind Code |
A1 |
Py; Daniel |
December 20, 2018 |
DEVICE FOR CONNECTING OR FILLING AND METHOD
Abstract
A valve comprises a shell, a flexible valve member sealingly
mounted within the shell, and a valve body mounted atop the
flexible valve member within the shell. The flexible member is
moveable between closed and open positions to allow the flow of
fluid therethrough. The valve is engageable with a filling device
having flow ports and a surrounding closure. The closure and/or the
shaft is movable between (i) a first position wherein the closure
closes the port(s), and (ii) a second position opening the port(s).
Alternatively, the valve may comprise a portion of a female
connector and the filling device may comprise a portion of a male
connector to form an aseptic fluid connector for the aseptic
transfer of fluid therethrough.
Inventors: |
Py; Daniel; (Larchmont,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DR. PY INSTITUTE LLC |
New Milford |
CT |
US |
|
|
Family ID: |
49511833 |
Appl. No.: |
16/000172 |
Filed: |
June 5, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13874839 |
May 1, 2013 |
9989177 |
|
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16000172 |
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61794255 |
Mar 15, 2013 |
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61641248 |
May 1, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
F16L 29/02 20130101;
A61M 2039/268 20130101; A61M 39/26 20130101; A61M 39/18 20130101;
B65B 3/003 20130101; B65B 39/001 20130101 |
International
Class: |
F16L 29/02 20060101
F16L029/02; A61M 39/26 20060101 A61M039/26; B65B 3/00 20060101
B65B003/00; B65B 39/00 20060101 B65B039/00 |
Claims
1-92. (canceled)
93. An apparatus, comprising: a first portion including a conduit
comprising a hollow interior, at least one port in fluid
communication with the interior, and a closure; wherein one or more
of the closure or the conduit is movable between (i) a first
position wherein the closure closes the at least one port, and (ii)
a second position opening the at least one port; a second portion
adapted to engage the first portion and including (1) a valve,
having a valve member and a valve seat, configured to be moved
between (i) a closed position, wherein the valve member and the
valve seat sealingly engage each other, thereby preventing the flow
of substance through the valve, and (ii) an open position, wherein
the valve member and the valve seat are disengaged from each other
to allow the flow of substance through the valve, and (2) a septum
overlying one or more of the valve member or the valve seat;
wherein one or more of the first portion or the second portion is
moveable relative to each other between (i) a disconnected position
wherein the one or more of the closure or the conduit is in the
first position and the valve is in the closed position and (ii) a
connected position wherein the conduit has engaged and moved the
valve from the closed position to the open position and the one or
more of the closure or the conduit is in the second position
opening the at least one port; and wherein the closure is adapted
to one or more of: (a) at least partially penetrate the septum or
(b) be interposed between the at least one filling port and the
septum, during said movement between the disconnected position and
the connected position.
94. The apparatus as defined in claim 93, wherein the closure is
normally biased in a direction from the second position toward the
first position to normally close the at least one port.
95. The apparatus as defined in claim 93, wherein the valve member
is normally biased in a direction from the open position toward the
closed position, to normally sealingly close the valve from the
passage of substance therethrough.
96. The apparatus as defined in claim 93, wherein the septum
defines a septum passageway therein, said septum passageway adapted
to wipe the conduit during said movement between the disconnected
position and the connected position.
97. The apparatus as defined in claim 96, wherein the valve member
defines a recess or socket and the septum passageway substantially
aligns therewith, allowing the conduit to pass through the septum
and engage with the recess or socket.
98. The apparatus as defined in claim 97, wherein the recess or
socket and the septum passageway are of substantially a same width
or diameter.
99. The apparatus as defined in claim 93, wherein the septum
defines a thickness within the range of a thickness equivalent to
1/2 the width or diameter of the conduit to a thickness equivalent
to double the width or diameter of the conduit.
100. The apparatus as defined in claim 93, wherein at least a
portion of the closure is engageable with the septum to prevent
further movement of the closure relative to the second portion,
whereby subsequent movement of the first portion moves the one or
more of the closure or the conduit from the first position to the
second position.
101. The apparatus as defined in claim 93, wherein movement from
the disconnected position to the connected position achieves at
least approximately a 3 log reduction in bio-burden.
102. The apparatus as defined in claim 93, wherein, during or upon
movement from the connected to the disconnected position, one or
more of the closure or the conduit is movable from the second
position to the first position, and the valve is movable from the
open position to the closed position.
103. The apparatus as defined in claim 93, wherein the closure
extends annularly about the conduit.
104. An apparatus, comprising: first means for transferring
substance with a second means for engaging the first means and for
transferring substance with the first means; the first means
comprising third means for providing a conduit for the passage of
substance therethrough and for engaging fourth means of the second
means; the third means including fifth means for passage of
substance therethrough and in fluid communication with an interior
of the third means; and sixth means for closing the third means;
wherein one or more of the third means or the sixth means is
movable between (i) a first position wherein the sixth means closes
the fifth means; and (ii) a second position opening the fifth
means; the second means comprising seventh means overlying the
fourth means for engaging the third means prior to the third means
engaging the fourth means when the first means and the second means
are in a connected position with each other; wherein the fourth
means is moveable between (i) a closed position, wherein the fourth
means prevents the flow of substance therethrough; and (ii) an open
position, wherein the fourth means allows the flow of substance
therethrough; wherein one or more of the first means or the second
means is moveable relative to each other between (i) a disconnected
position wherein the one or more of the third means or the sixth
means is in the first position and the fourth means is in the
closed position; and (ii) the connected position wherein the third
means has engaged and moved the fourth means from the closed
position to the open position and the one or more of the third
means or the sixth means is in the second position opening the
fifth means; wherein the sixth means is adapted to one or more of:
(a) at least partially penetrate the seventh means or (b) be
interposed between the fifth means and the seventh means, during
movement between the disconnected position and the connected
position.
105. An apparatus as defined in claim 104, wherein the first means
is a first portion, the second means is a second portion, the third
means is a conduit, the fourth means is a valve, the fifth means is
a port, the sixth means is a closure, and the seventh means is a
septum.
106. A method comprising the following steps: engaging first and
second devices adapted to engage each other and transfer substance
therebetween, the first device including a conduit, a flow aperture
in fluid communication between an interior of the conduit and an
exterior of the conduit, and a closure, the second device
comprising a valve, an interior in fluid communication with the
valve, and a septum overlying the valve; hermetically sealing the
flow aperture and the interior of the conduit with respect to
ambient atmosphere with the closure and preventing the flow of
substance through the flow aperture; preventing substance from
flowing through the valve and hermetically sealing the interior of
the second device with respect to ambient atmosphere; engaging the
conduit and the valve; and opening the valve from a closed position
preventing substance from passing therethrough to an open position
allowing substance therethrough with the conduit; wherein the
method further comprises: before or during the step of engaging the
conduit and the valve, one or more of (a) at least partially
penetrating the septum with the closure or (b) interposing the
closure between the flow aperture and the septum; during or after
the said one or more of (a) at least partially penetrating the
septum with the closure or (b) interposing the closure between the
flow aperture, opening the flow aperture by moving the closure and
the conduit relative to each other; and after the opening steps,
transferring substance between the interior of the conduit and the
interior of the second device, the transferring step including
flowing substance through the valve and the flow aperture.
107. The method as defined in claim 106, wherein said substance is
aseptic or sterile, and the method further comprises maintaining
said aseptic or sterile during said transferring step.
108. The method as defined in claim 106, further comprising moving
the cannula through the septum.
109. An apparatus comprising: a first device comprising a conduit
including a first flow aperture, a second flow aperture in fluid
communication with the first flow aperture, and a closure; wherein
one or more of the closure or the conduit is movable between (i) a
first position where the closure closes the second flow aperture,
and (ii) a second position where the second flow aperture is open;
and a second device adapted to engage the first device and transfer
substance therebetween, and including a septum defining a
passageway therethrough configured to receive at least a portion of
the conduit therein during engagement of the first and second
devices, wherein the septum is configured to wipe contaminants from
the at least a portion of the conduit during passage thereof
through the passageway.
110. An apparatus as defined in claim 109, wherein the septum
comprises an elastomeric material.
111. An apparatus as defined in claim 109, wherein the septum is
configured so that said wiping achieves at least approximately a 3
log reduction in bio-burden on the at least a portion of the
conduit.
112. An apparatus as defined in claim 109, wherein the passageway
is configured to receive at least a portion of the closure during
passage of the at least a portion of the conduit through the
passageway.
113. An apparatus as defined in claim 112, wherein the closure is
in the first position during at least a portion of passage of the
at least a portion of the conduit through the passageway.
114. An apparatus as defined in claim 109, wherein, during at least
a portion of passage of the at least a portion of the conduit
through the passageway, the second flow aperture is substantially
prevented from contacting the septum.
115. An apparatus as defined in claim 109, wherein, during at least
a portion of passage of the at least a portion of the conduit
through the passageway, the closure is interposed between the
second flow aperture and the septum to substantially prevent
contact between the second flow aperture and the septum.
116. An apparatus as defined in claim 109, configured so that the
movement from the first position to the second position occurs
during or after passage of the at least a portion of the conduit
through the passageway.
117. An apparatus as defined in claim 109, wherein the septum
defines a durometer within the range of about 20 Shore A to about
50 Shore A.
118. An apparatus as defined in claim 109, wherein the septum
defines a thickness at least about 1/2 of a diameter of the
conduit.
119. An apparatus as defined in claim 109, wherein, in the first
position, the closure hermetically seals the second flow aperture
from ambient atmosphere.
120. An apparatus as defined in claim 109, wherein, after passage
of the at least a portion of the conduit through the passageway,
the one or more of the closure or the conduit is in the second
position, the second flow aperture is open, and the septum seals
the flow outlet from the ambient atmosphere.
121. An apparatus as defined in claim 109, wherein the septum is
configured to exert a radial or compressive force on the at least a
portion of the conduit during passage thereof through the
passageway.
122. An apparatus as defined in claim 109, wherein the conduit
includes an end thereof extending past the closure in the first
position, and the septum is configured to wipe contaminants from
the end upon passage of the end through the passageway.
123. A method comprising: engaging a first device and a second
device, wherein the first device comprises a conduit including a
first flow aperture, a second flow aperture in fluid communication
with the first flow aperture, and a closure; wherein one or more of
the closure or the conduit is movable between (i) a first position
where the closure closes the second flow aperture, and (ii) a
second position where the second flow aperture is open, and the
second device is adapted to engage the first device and transfer
substance therebetween, and includes a septum defining a passageway
therethrough configured to receive at least a portion of the
conduit therein during said engaging of the first and second
devices, wherein the septum is configured to wipe contaminants from
the at least a portion of the conduit during passage thereof
through the passageway; passing the at least a portion of the
conduit through the passageway; and wiping contaminants from the at
least a portion of the conduit during said passing step.
124. A method as defined in claim 123, further including, during
the wiping step, achieving at least approximately a 3 log reduction
in bio-burden on the at least a portion of the conduit.
125. A method as defined in claim 123, further including receiving
at least a portion of the closure within the passageway during said
passing step.
126. A method as defined in claim 125, further including
maintaining the closure is in the first position during at least a
portion of the passing step.
127. A method as defined in claim 123, further including
substantially preventing the second flow aperture from contacting
the septum during at least a portion of the passing step.
128. A method as defined in claim 123, further including one or
more of interposing the closure between the second flow aperture
and the septum during at least a portion of the passing step, or
substantially preventing contact between the second flow aperture
and the septum during said at least a portion of the passing
step.
129. A method as defined in claim 123, further including moving the
one or more of the closure or the conduit from the first position
to the second position during or after said passing step.
130. A method as defined in claim 123, wherein one or more of (a)
the septum comprises an elastomeric material, (b) the septum
defines a durometer within the range of about 20 Shore A to about
50 Shore A, or (c) the septum defines a thickness at least about
1/2 of a diameter of the conduit.
131. A method as defined in claim 123, further including
hermetically sealing the second flow aperture from ambient
atmosphere with the closure in the first position.
132. A method as defined in claim 123, further including sealing
the second flow aperture from ambient atmosphere with the septum in
the second position.
133. A method as defined in claim 123, further including exerting a
radial or compressive force on the at least a portion of the
conduit during the passing step.
134. A method as defined in claim 123, wherein the conduit includes
an end thereof extending past the closure in the first position,
and further including wiping contaminants from the end during the
passing step.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 13/874,839, filed May 1, 2013, which claims
benefit under 35 U.S.C. .sctn. 119 to similarly-titled U.S.
Provisional Patent Application Nos. 61/641,248, filed May 1, 2012,
and 61/794,255, filed Mar. 15, 2013, both of which are hereby
incorporated by reference in their entirety as part of the present
disclosure.
FIELD OF THE INVENTION
[0002] The present invention relates to filling devices and
connectors, and methods of filling and transferring fluids, and
more particularly to methods of aseptically filling devices and
connectors for the aseptic filling and transfer of fluids.
BACKGROUND
[0003] A typical previously-known filling cannula or probe used for
aseptic or so called "sterile" filling comprises a hollow filling
tube including an outlet port in fluid communication between the
hollow interior of the filling tube and ambient atmosphere. A
previously-known filling cannula or probe, for example, includes a
hollow stainless steel shaft, a bulbous tip fixedly secured to the
distal end of the shaft, and diametrically opposed outlet ports
proximal to the tip and in fluid communication between the interior
of the shaft and the ambient atmosphere. One drawback encountered
with previously-known filling cannulas and needles is that the
interior of the cannula or probe, and any fluid contained therein
or passing therethrough, can be exposed to the ambient atmosphere
via the open fluid ports. In connection with known filling
machines, regulatory agencies require control of the cannula or
probe environment in order to protect against exposure of a sterile
product to the environment and the resulting contamination of the
product that might occur. However, typical controlled environments,
such as a class 100 (ISO-5) controlled environment, are not truly
sterile. Although the likelihood of contamination in such
reduced-contaminant environments may be relatively low, just one
colony of contaminants can develop into a container full of germs
over its shelf-life. This risk is exacerbated when filling
traditional open containers that are thereafter sealed in an
assembly machine. No such previously-known assembly machine, such
as, for example, a typical machine closing 40,000 containers per
hour, can fully prevent entrance of viables and non-viables into
the containers. On the other hand, if the cannula or probe is used
to dispense a contaminated fluid, or a fluid that might be harmful
if it is exposed to or comes into contact with an operator, the
open ports can allow such fluid to contaminate its ambient
atmosphere or potentially harm the operator that contacts the
cannula or probe or is in the vicinity thereof.
[0004] A typical fluid connector includes a male connector that is
received within a female connector to place the two connectors in
fluid communication with each other. The male and female connectors
may be threadedly engaged, snap fit, or otherwise releasably
connected to each other to allow for interconnection and
disconnection. Each connector is coupled in fluid communication
with a respective fluid passageway, such as a tube or fluid
chamber, in order to place the fluid passageways in fluid
communication with each other and allow the passage of fluids
through the connected elements.
[0005] Such fluid connectors typically do not prevent the
contamination of fluids passing through them, unless the connector
is sterile handled and connected in a relatively low challenging
environment (even then, the connectors must be sealingly connected
to each other to prevent ingress of contaminants, which means the
connection cannot be disengaged). For example, prior to
interconnection of the male and female connectors, the
fluid-contacting surfaces thereof can be exposed to the ambient
atmosphere and contaminated through contact with airborne germs
and/or by contact with contaminated surfaces. One approach to
preventing such contamination is to wipe the fluid-contacting
surfaces of the male and female connectors with an alcohol wipe or
other disinfectant prior to interconnection. One drawback of this
approach is that the fluid-contacting surfaces may become
contaminated after the wipe is applied to the male and female
connectors. Another drawback of this approach is that it can be
time consuming and considered a nuisance, and therefore unreliable
in practice. There is no previously-known connector capable
connection within a contaminated liquid or contaminated aerosol
chamber that prevents the contamination of fluids passing
therethrough.
[0006] Accordingly, aseptic or sterile fluids can be subjected to
contamination when passed through such previously-known connectors.
If used in a hospital or other medical facility, such as to
transfer sterile drugs or other fluids intended for intravenous
injection, for example, any such contamination can lead to
bloodstream infections, e.g., catheter related blood stream
infections (CRBSI). CRBSI represent about 15% of nosocomial
infections per year. According to the Center for Disease Control
(CDC), approximately 200,000 cases CRBSI are reported in the United
States per year and cost the country about $35 billion in treatment
costs. CRBSI leads to about 30,000 deaths per year in United States
hospitals. In food processing applications, on the other hand, it
may be necessary to connect fluid conduits, for example, in order
to transfer sterile or aseptic fluids from one passageway to
another. If the fluids are contaminated upon passage through a
fluid connector, this can lead to contamination of
previously-sterile food products, and if such contaminated products
are ingested, they can cause infections and/or illnesses. In
industrial applications, it may be necessary to prevent a toxic
fluid passing through a connector from contaminating the ambient
atmosphere, an operator handling the connector, and/or other
surfaces that might be located external to the connector. If the
fluid-contacting surfaces of the connector are exposed to human
contact, or surfaces that come into human contact, for example,
this can lead to possible injury and/or illnesses. For example,
operators exposed to the transfer of liquids such as immune
suppressants or hormones, can suffer from pulmonary absorption of
such products.
SUMMARY OF THE INVENTION
[0007] 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, including to reduce the risk of contamination of a fluid
during transfer and/or filling thereof, and mitigating illness and
death from nosocomial infections.
[0008] In accordance with a first aspect, a device comprises a tube
including a flow inlet, a flow outlet in fluid communication with
the flow inlet, and a closure; wherein at least one of the closure
and the tube is movable between (i) a first position where the
closure closes the flow outlet, and (ii) a second position where
the flow outlet is open. To prevent contamination, the closure
forms a substantially fluid-tight seal between the flow outlet and
ambient atmosphere.
[0009] In some embodiments, the closure is biased in a direction
from the second position toward the first position to normally
close the flow outlet. In some such embodiments, the device
includes a spring biasing the closure in the direction from the
second position toward the first position.
[0010] In some embodiments, the tube is connectable to a device for
filling, having a valve connected to a chamber thereof, where in
the second position, the flow outlet is connectable in fluid
communication with the chamber through the valve to fill substance
from the flow inlet, through the flow outlet and valve, and into
the chamber. In some such embodiments the device for filling
includes a septum overlying the valve, and the closure is
engageable with the septum to allow movement of at least one of the
tube and closure relative to the other from the first position to
the second position during or after movement of the tube through
the septum. In some such embodiments, the valve includes a recess,
the tube includes a tip that is receivable within the recess, and
the closure is engageable with the device to be filled to allow
movement of at least one of the tube and closure relative to the
other from the first position to the second position during or
after movement of the tube tip into the recess. In some such
embodiments, he valve includes a spring that normally biases the
valve in the direction from the open position to the closed
position. In some such embodiments, the valve spring is
approximately dome shaped.
[0011] In accordance with another aspect, a device comprises first
means for the flow of substance to be filled therethrough; second
means in fluid communication with the first means for the passage
of the substance from the first means therethrough; and third means
for opening and closing the third means, wherein at least one of
the first means and the third means is movable between (i) a first
position where the third means closes the second means, and (ii) a
second position where the second means is open.
[0012] In some embodiments, the first means is a tube, the second
means is a flow outlet of the tube, and the third means is a
closure.
[0013] In some embodiments, the device further comprises fourth
means for biasing the third means in a direction from the second
position toward the first position to normally close the second
means.
[0014] In accordance with another aspect, a method comprises the
following steps:
(i) introducing an aseptic or sterile substance into a cannula;
(ii) sealing an outlet of the cannula with respect to ambient
atmosphere and preventing the flow of aseptic or sterile substance
in the cannula from flowing through the outlet; and (iii) opening
the outlet of the cannula and introducing the aseptic or sterile
substance from the cannula through the outlet and into a storage
chamber of a device to be filled.
[0015] In some embodiments the cannula further includes a tube
defining an inlet and the outlet, and a closure, wherein the step
of opening further comprises moving at least one of the closure and
the tube between (i) a first position, where the closure closes the
outlet, and (ii) a second position wherein the outlet is open. In
some such embodiments, the method further comprises sealing the
outlet from ambient atmosphere in the first position. In some such
embodiments the method further comprises passing the cannula
through a septum coupled to a valve in fluid communication with the
storage chamber, engaging the valve, and introducing the aseptic or
sterile substance from the outlet of the cannula through the valve.
In some such embodiments, the engaging step further comprises
opening the valve to allow the introduction of substance through
the valve and into the storage chamber. In some such embodiments
the step of opening the valve comprises moving a flexible valve
member of the valve from a sealingly closed position to an open
position.
[0016] In some embodiments, the method further comprises
disengaging the cannula from the valve; and before or during the
disengaging step, moving at least one of the closure and the tube
from the second position to the first position, and simultaneously
moving the valve from the open position to the sealing closed
position.
[0017] In some embodiments, contact is substantially prevented
between the outlet of the cannula and the septum during the
engaging and disengaging steps. In some such embodiments, the
closure is interposed between the outlet of the cannula and the
septum to substantially prevent any contact between the outlet and
the septum.
[0018] In some embodiments, the method further comprises engaging,
introducing and disengaging steps in a non-sterile environment or
an environment defining a SAL of about 6 log bio-burden on the
surface or less; introducing a sterile fluid through the cannula
and into the storage chamber; and maintaining the sterility of the
filled fluid throughout the engaging, introducing and disengaging
steps.
[0019] In accordance with another aspect, a connector comprises a
first connector portion including a filling member comprising a
hollow shaft, a tip formed at one end of the shaft, at least one
port in fluid communication with an interior of the hollow shaft,
and a closure; wherein at least one of the closure and the shaft is
movable between (i) a first position wherein the closure closes the
at least one port, and (ii) a second position opening the at least
one port. The connector further includes a second connector portion
adapted to engage the first connector portion and including a
valve, which can have a flexible valve member and a valve seat
configured to be moved between (i) a closed position, wherein the
flexible valve member is sealingly engaged by the valve seat,
thereby preventing the flow of fluid therethrough, and (ii) an open
position, wherein the flexible valve member is disengaged from the
valve seat to allow the flow of fluid therethrough; wherein at
least one of the first connector portion and the second connector
portion is moveable relative to each other between (i) a
disconnected position wherein the at least one of the closure and
the shaft is in the first position and the valve is in the closed
position and (ii) a connected position wherein the filling member
has engaged and moved the valve from the closed position to the
open position and the at least one of the closure and the shaft is
in the second position opening the at least one port.
[0020] In some embodiments, the closure forms a substantially
fluid-tight seal between the at least one port and the ambient
atmosphere in the first position.
[0021] In some embodiments, the closure is normally biased in the
direction from the second position toward the first position to
normally close the at least one port.
[0022] In some embodiments, the flexible valve member is normally
biased in the direction from the open position toward the closed
position, to normally sealingly close the valve from the passage of
fluid therethrough.
[0023] In some embodiments, the first connector portion further
includes a biasing member normally biases the closure in the
direction from the second position to the first position. In some
such embodiments, the biasing member includes a sealing member for
sealing engaging the hollow shaft of the filling member. In some
such embodiments, the sealing member is integrally formed with the
biasing member. In some such embodiments, the sealing member
comprises an O-ring. In some embodiments, the biasing member is an
approximately dome-shaped elastic spring.
[0024] In some embodiments, the flexible valve member comprises an
integral spring that normally biases the flexible valve member in
the direction from the open position toward the closed position, to
normally sealingly close the valve from the passage of fluid
therethrough. In some such embodiments, the integral spring is an
elastic approximately dome-shaped spring.
[0025] In some embodiments, the first connector portion further
includes a one-way valve. In some such embodiments, the one-way
valve is configured to vent out air from a chamber defined by dome
shaped spring biasing member to the ambient atmosphere, when the at
least one of the closure and the shaft is moved from the first
position to the second position. In some such embodiments, the
one-way valve is configured to vent in air from the ambient
atmosphere into the chamber defined by the dome shaped spring
biasing member, when the at least one of the closure and the shaft
is moved from the second position to the first position. In some
such embodiments, the one-way valve is integrally formed with the
approximately dome shaped spring biasing member.
[0026] In some embodiments, the second connector portion further
comprises a septum overlying the flexible valve member of the
valve. In some such embodiments, the septum defines a durometer
within the range of about 5 Shore A to about 65 Shore A. In some
such embodiments, the septum defines a durometer within the range
of about 25 Shore A to about 45 Shore A. In some such embodiments,
the septum defines a thickness within the range of a thickness
equivalent to about 1/2 the diameter of the filling member to a
thickness equivalent to about double the diameter of the filling
member.
[0027] In some embodiments the closure is engageable with the
septum of the second connector portion to prevent further movement
of the closure relative to the second connector portion, whereby
subsequent movement of the first connector portion moves the shaft
from the first position to the second position.
[0028] In some embodiments, movement of one of the first connector
portion and the second connector portion relative to the other of
the first connector portion and the second connector portion from
the disconnected position to the connected position achieves at
least approximately a 3 log reduction in bio-burden.
[0029] In some embodiments, at least one of the closure and the
shaft is movable from the second position to the first position,
and the valve is movable from the open position to the closed
position during or upon disengaging the filling member from the
valve.
[0030] In some embodiment, the closure includes a shutter extending
annularly about the shaft.
[0031] In accordance with another aspect, a connector comprises:
first means for providing fluid to a second means for engaging the
first means and for receiving fluid from the first means; the first
means comprising third means for providing a conduit for the
passage of fluid therethrough; fourth means formed at one end of
the third means for engaging a valve; fifth means in fluid
communication with the third means for passage of fluid from the
third means therethrough; and sixth means for closing the third
means; wherein at least one of the third means and the sixth means
is movable between (i) a first position wherein the sixth means
closes the fifth means; and (ii) a second position opening the
fifth means; the second means comprising seventh means for engaging
by the third means when the first means and the second means are in
a connected position with each other; wherein a the seventh means
is moveable between (i) a closed position, wherein the seventh
means prevents the flow of fluid therethrough; and (ii) an open
position, wherein the seventh means allows the flow of fluid
therethrough; wherein at least one of the first means and the
second means is moveable relative to each other between (i) a
disconnected position wherein the at least one of the third means
and the sixth means is in the first position and the seventh means
is in the closed position; and (ii) a connected position wherein
the fifth means has engaged and moved the seventh means from the
closed position to the open position and the at least one of the
third means and the sixth means is in the second position opening
the fifth means.
[0032] In some embodiments, the first means is a first connector
portion, the second means is a second connector portion, the third
means is a filling member, the fourth means is a tip of the filling
member, the fifth means is at least one port, the sixth means is a
closure, and the seventh means is a valve.
[0033] In accordance with another aspect, a method comprises the
following steps:
(i) engaging a first connector portion with a second connector
portion, the first connector portion including a filling member
comprising a hollow shaft, a tip formed at one end of the shaft, at
least one port in fluid communication with an interior of the
hollow shaft, and a closure; wherein at least one of the closure
and the shaft is movable between (i) a first position wherein the
closure closes the at least one port, and (ii) a second position
opening the at least one port; wherein the second connector portion
is adapted to engage the first connector portion and including a
valve, having a flexible valve member and a valve seat, configured
to be moved between (i) a closed position, wherein the flexible
valve member is sealingly engaged by the valve seat, thereby
preventing the flow of fluid therethrough, and (ii) an open
position, wherein the flexible valve member is disengaged from the
valve seat to allow the flow of fluid therethrough; and at least
one of the first connector portion and the second connector portion
is moveable relative to each other between (i) a disconnected
position wherein the at least one of the closure and the shaft is
in the first position and the valve is in the closed position and
(ii) a connected position wherein the filling member has engaged
and moved the valve from the closed position to the open position
and the at least one of the closure and the shaft is in the second
position opening the at least one port; (ii) moving at least one of
the first connector portion and the second connector portion
relative to each other from the disconnected position toward the
connected position; (iii) engaging the valve with the filling
member (iv) moving the valve from the open position to the closed
position; (v) moving at least one of the closure and the shaft from
the first position closing the at least one port to the second
position opening the at least one port; and (vi) introducing fluid
from the shaft through the at least one port and the valve.
[0034] In some embodiments, the step of moving at least one of the
closure and the shaft from the first position to the second
position occurs with the step of moving the valve from the open
position to the closed position.
[0035] In some embodiments, the method further comprises the step
of sterilizing the first connector portion and the second connector
portion.
[0036] In some embodiments, the step of moving at least one of the
first connector portion and the second connector portion relative
to each other from the disconnected position toward the connected
position comprises both axial and rotational movement.
[0037] In some embodiments, the second connector portion further
comprises a septum overlying the valve and the step of moving at
least one of the first connector portion and the second connector
portion relative to each other from the disconnected position
toward the connected position further comprises moving the filling
member through the septum and wiping the filling member with the
septum. In some such embodiments, the wiping step comprises wiping
the tip of the filling member with the septum. In some such
embodiments, the wiping step comprises wiping the filling member
with a septum defining a durometer within the range of about 5
Shore A to about 65 Shore A. In some such embodiments, the wiping
step comprises wiping the piercing member with a septum defining a
durometer within the range of about 25 Shore A to about 45 Shore A.
In some such embodiments, the wiping step comprises wiping the
filling member with a septum defining a thickness with the range of
a thickness equivalent to about 1/2 the diameter of the filling
member to a thickness equivalent to about double the diameter of
the filling member. In some such embodiments, the wiping step
achieves at least approximately a 3 log reduction in bio-burden of
the filling member.
[0038] In accordance with another aspect, the method further
comprises the following steps:
(vii) disengaging the filling member from the valve; (viii) before
or during the disengaging step, moving at least one of the closure
and the shaft from the second position to the first position, and
moving the valve from the open position to the closed position;
(ix) moving the at least one of the first connector portion and the
second connector portion relative to each other from the connected
position to the disconnected position; and (x) separating the first
connector portion and the second connector portion.
[0039] In some embodiments, contact between the at least one
filling port and the septum if substantially prevented during the
engaging and disengaging steps.
[0040] In some embodiments, the method further comprises performing
the engaging, introducing and disengaging steps in a non-sterile
environment or an environment defining a SAL of about log 3 or
less; introducing a sterile fluid through the first and second
connector portions; and maintaining the sterility of the filled
fluid throughout the engaging, introducing and disengaging
steps.
[0041] One advantage of the present invention is that it provides a
closed system sterile transfer, such that product transferred
within the system does not come in contact with the external
environment or contaminants therefrom. Another advantage of the
present inventions is that the filling device and the connector can
aseptically fill and transfer fluid within a non-aseptic,
non-sterile or relatively low SAL environment (e.g., about log 6 or
lower). 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
and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] FIG. 1 is a cross-sectional view of a first embodiment of a
valve coupled to a device having a chamber for filling and
dispensing fluids or other substances therefrom;
[0043] FIG. 2 is an exploded, cross-sectional view of the valve of
FIG. 1;
[0044] FIG. 3 is a cross-sectional view of the valve of FIG. 1, in
the closed position;
[0045] FIG. 4 is a cross-sectional view of the valve of FIG. 1, in
the open position;
[0046] FIG. 5 is a cross-sectional view of a corresponding filling
member engageable with the valve of FIG. 1;
[0047] FIGS. 6A through 6C are sequential cross-sectional views of
the filling member of FIG. 5 mating with the valve of FIG. 1 for
filling a device or chamber attached thereto through the valve;
[0048] FIG. 7 is a schematic view of another embodiment of a valve
comprising a portion of a female connector, and another embodiment
of a filling member, comprising a portion of a male connector, for
connecting together and transferring fluid therethrough;
[0049] FIG. 8 is a perspective view of the male connector of FIG.
7;
[0050] FIG. 9 is a perspective view of the female connector of FIG.
7;
[0051] FIGS. 10A through 10F are sequential cross-sectional views
of the male and female connectors of FIG. 7, showing the male
connector from alignment and engagement with the female connector,
to full connection with the female connector, for transferring
fluid therethrough;
[0052] FIGS. 11A through 11F are sequential perspective views of
the male and female connectors of FIG. 7, showing the male
connector from alignment and engagement with the female connector,
to full connection with the female connector, for transferring
fluid therethrough;
[0053] FIG. 12 is a perspective view of another embodiment of a
valve comprising a portion of a connector coupled to a storage
chamber for filling and dispensing fluids or other substances
therefrom;
[0054] FIG. 13A is a cross-sectional partial view of the connector
of FIG. 12 taken along the centerline of the connector, prior to
engagement with a delivery device, with the valve in the first
closed position; and
[0055] FIG. 13B is a cross-sectional partial view of the connector
of FIG. 12 taken along the centerline of the connector, upon
engagement with a delivery device, with the valve in the second
open position.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
[0056] In FIG. 1 a valve is indicated generally by the reference
numeral 10. The valve 10 comprises a shell 12, a flexible valve
member 16 sealingly mounted within the shell 12 and a valve body 14
mounted atop the flexible valve member 16 within the shell 12, as
explained further below. In some embodiments, the shell 12 is made
of a polymeric or thermoplastic material such as polypropylene (PP)
or high-density polyethylene (HDPE). However, as may be recognized
by those of ordinary skill in the pertinent art based on the
teachings herein, the shell may be made of any of numerous
different materials that are currently known or that later become
known. The valve 10 is connected, at a bottom end thereof, in fluid
communication with a container 18, defining a storage chamber 20
therein, via a neck 22. In the illustrated embodiment, the
container 18 is a pouch. However, as may be recognized by those of
ordinary skill in the pertinent art based on the teachings herein,
the container may define any of numerous containers or devices
defining storage chambers therein having any of numerous different
configurations.
[0057] As shown in FIG. 2, the flexible valve member 16 comprises
an upper substantially cylindrical shaped portion 24 atop a lower
approximately dome or spherical-shaped portion 26. The upper
portion 24 of the flexible valve member 16 is rigid relative to the
lower portion 26. In the illustrated embodiment, the upper portion
24 is over-molded atop the lower portion 26. The upper
substantially cylindrical shaped portion 24 defines a substantially
cylindrical sidewall 28 and a top surface 30. The sidewall 28
functions as a cylindrical sealing surface, as described further
below. The upper portion 24 further defines an axially extending
socket 32, axially extending downwards into the upper portion from
the top surface 30 for mating with a filling device 70, as
described further below. In some embodiments, as shown in FIGS. 3
and 4, the upper portion 24 may further include an annular
retaining member 34, axially extending upwards from the top surface
30, for sealingly engaging an adjacent septum 60 of the valve body
14 when in the closed position, as described further below.
[0058] The lower approximately dome or spherical-shaped portion 26
defines an integral spring 36. In some embodiments, the lower
portion 26 is made of an elastomeric flexible material such as
silicone and glass filled polybutylene terephthalate (PBT) or a
silicone blend. However, as may be recognized by those of ordinary
skill in the pertinent art based on the teachings herein, the lower
approximately dome or spherical-shaped portion may take any of
numerous different shapes and/or configurations, or may be formed
of any of numerous different materials, that are currently known,
or that later become known, for performing the function of the
integral spring as described herein. The integral spring 36 of the
lower approximately dome or spherical-shaped portion 26 allows the
flexible valve member 16 to move axially between a normally closed
position, as shown in FIG. 3, and an open position, as shown in
FIG. 4. The integral spring 36 naturally biases the flexible valve
member 16 into the normally closed position, where the cylindrical
sealing surface 28 of the substantially cylindrical upper portion
24 sealingly engages a corresponding cylindrical valve seat 56 of
the valve body 14 (described further below) to form a fluid-tight
seal therebetween, thereby preventing the flow of substance into
and/or out of the chamber 20, and hermetically sealing a substance
contained within the chamber from the ambient atmosphere. The
flexible valve member 16 may be depressed into the open position,
where the cylindrical sealing surface is moved out of engagement
with the cylindrical valve seat 56 and, in turn, permits the
passage of substance therethrough to both introduce the substance
into the chamber 20, as shown by the arrows in FIG. 4, and/or
dispense the substance therefrom.
[0059] The lower portion 26 includes a flow aperture 38 to allow
the flow of substance therethrough when in the open position.
However, as may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, the lower portion 26
may include any desired number of flow apertures, and the apertures
may take any of numerous different configurations in order to, for
example, achieve the desired flow of substance into and/or out of
the chamber 20. The lower portion 26 further includes an annular
flange 40 laterally projecting therefrom, proximally adjacent a
lower end of the lower portion. The annular flange 40 defines an
annular recess 42 in a bottom end thereof for sealingly receiving a
corresponding first annular retaining member 44 of the shell 12, to
sealingly mount the flexible valve member 16 within the shell 12.
In the illustrated embodiment, the first annular retaining member
44 is in the form of an annular spike. However, as may be
recognized by those of ordinary skill in the pertinent art based on
the teachings herein, the retaining member may take any of numerous
different configurations that are currently known, or that later
become known, for sealingly engaging the annular flange of the
flexible valve member.
[0060] As illustrated in FIG. 1, the valve body 14 is sealingly
mounted atop the flexible valve member 16 within the shell 12. In
some embodiments, the valve body 14 is made of silicone and glass
filled (PBT) or polypropylene and a silicone blend. However, as may
be recognized by those of ordinary skill in the pertinent art based
on the teachings herein, the valve body may be formed of any of
numerous different materials that are currently known, or that
later become known. In the illustrated embodiment, the valve body
14 is substantially hollow and cylindrical, having a substantially
cylindrical sidewall 46. As shown in FIG. 2, the valve body 14
includes an annular flange 48 laterally projecting from an upper
end of the sidewall 46. The annular flange 48 defines an annular
recess 50 in a bottom end thereof for sealingly receiving a
corresponding second annular retaining member 52 of the shell 12,
to sealingly mount the valve body 14 within the shell 12, atop the
flexible valve member 16. In the illustrated embodiment, the second
annular retaining member 52 is in the form of an annular spike.
However, as may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, the retaining member
may take any of numerous different configurations that are
currently known, or that later become known, for sealingly engaging
the annular flange of the valve body.
[0061] In the illustrated embodiment, the second annular retaining
member 52 of the shell 12 is axially recessed from an upper end of
the shell 12. Consequently, when the valve body 14 is mounted
therein, an upper end of the valve body 14 is correspondingly
axially recessed from the upper end of the shell 12, thereby
defining a portion of the sidewall of the shell 12, from the upper
end of the valve body 14 to the upper end of the shell 12, as an
axially-extending ledge 54. When the valve body 14 is mounted, the
lower end of the cylindrical sidewall 46 of the valve body presses
onto the top end of the laterally projecting annular flange 40 of
the flexible valve member 16, thereby ensuring a sealing fit
between the annular flange 40 and the first annular retaining
member 44 of the shell 12.
[0062] As shown in FIG. 2, the valve body 14 further includes a
central cylindrical valve seat 56, axially recessed from the upper
end of the valve body, and axially extending downward. The valve
seat 56 sealingly engages the cylindrical sealing surface 28 of the
flexible valve member 16, to form a fluid-tight seal therebetween
when the flexible valve member 16 is in the closed position, as
described above. The cylindrical valve seat 56 defines a flow
aperture 58 therethrough, configured be in fluid communication with
the flow aperture 38 of the valve member 16 when the valve member
is in the open position, to allow the flow of substance
therethrough. As may be recognized by those of ordinary skill in
the pertinent art based on the teachings herein, the valve seat 56
may include any desired number of flow apertures 58, and the
apertures may take any of numerous different configurations in
order to, for example, achieve the desired flow of substance into
and/or out of the chamber 20.
[0063] The upper end of the valve body 14 further defines an
annular recess for fittingly receiving a septum 60 atop the
axially-recessed cylindrical valve seat 56. In the illustrated
embodiment, the septum 60 is over-molded into the annular recess
and defines a top surface, flush with the top surface of the valve
body, together defining a stop surface 62 of the valve body 14, as
shown in FIG. 2. A bottom end of the septum 60 sealingly engages
the top surface 30 of the upper portion 24 when the flexible valve
member 16 is in the closed position, as described above. As shown
in FIG. 2, the septum 60 also defines a septum passageway 64
axially extending therethrough. The septum passageway 64 is
configured to align with the axially extending socket 32 of the
upper portion 24 of the valve member 16, and is of substantially
equal diameter thereto, for allowing the filling device 70 to pass
therethrough and mate with the socket 32. In some embodiments, the
septum 60 is made of an elastomeric material. However, as may be
recognized by those of ordinary skill in the pertinent art based on
the teachings herein, the septum may be formed of any of numerous
different materials that are currently known, or that later become
known, for performing the function of the septum as described
herein.
[0064] In FIG. 5, a filling device for mating with the valve 10, in
accordance with another embodiment, is indicated generally by the
reference numeral 70. An exemplary embodiment of a filling device
is disclosed in co-pending U.S. Provisional Patent Application No.
61/659,382, filed Jun. 13, 2012, entitled "Device with Penetrable
Septum, Filling Needle and Penetrable Closure, and Related Method"
and similarly titled U.S. Provisional Patent Application No.
61/799,744, filed Mar. 15, 2013, and U.S. patent application Ser.
No. 13/450,306, filed Apr. 18, 2012, entitled "Needle with Closure
and Method," which, in turn claims benefit of U.S. Provisional
Application No. 61/476,523, filed Apr. 18, 2011, entitled "Filling
Needle and Method," all of which are hereby expressly incorporated
by reference in their entireties as part of the present disclosure
as if fully set forth herein. In the illustrated embodiment, the
filling device 70 is a cannula. However, as may be recognized by
those of ordinary skill in the pertinent art based on the teachings
herein, the filling device may define any of numerous filling
devices that are currently known, or that later become known,
capable of performing the function of the filling device as
described herein, such as, for example, a probe. The filling device
70 comprises a hollow shaft 72, a plunger 74 engaging the hollow
shaft 72 at a proximal end thereof, a tip 76 formed at an opposing
distal end thereof, and a surrounding closure 78, having a distal
surface 80. The hollow shaft 72 defines two flow ports 82 in fluid
communication with the interior of the hollow shaft. In the
illustrated embodiments, the two ports are diametrically opposed
relative to each other. However, as may be recognized by those of
ordinary skill in the pertinent art based on the teachings herein,
the shaft may define any number of ports that may define any of
numerous different configurations and locations. A proximal end of
the filling device 70 may be attached to a filling line or tubing
(not shown), for deploying a substance into the shaft 72. As may be
recognized by those of ordinary skill in the pertinent art based on
the teachings herein, any of numerous different types of fittings
or connections that are currently known, or that later become
known, may be employed for connecting the filling device to a
filling or other type of line, tube or conduit.
[0065] In the illustrated embodiment, the closure 78 is axially
slideable, having an internal central cylindrical shutter 84
located at a distal end thereof, that slides axially over the shaft
72 and the flow ports 82. The shutter 84 projects from inside the
distal end of the closure 78 to the tip 76 of the shaft 72 to seal
off the ports 82 from the ambient atmosphere. In the illustrated
embodiment of FIG. 6B, the shutter 84 projects out of the distal
surface 80 of the closure a distance approximately equivalent to
the length of the septum passageway 64. The closure 78 and/or the
shaft 72 is movable between (i) a first position, wherein the
cylindrical shutter 84 closes the ports 82, as shown in FIG. 6A,
and (ii) a second position, wherein the cylindrical shutter 84 is
displaced away from the ports 82, thereby opening the ports, as
shown in FIG. 6C. In the first position, the shutter 84 forms a
substantially fluid-tight seal between the ports 82 and the ambient
atmosphere. A distal end of 85 of the shutter 84 is engageable with
an annular stop surface 87 of the shaft tip 76 to stop the closure
and shutter in the first or closed position.
[0066] In the illustrated embodiment of FIG. 5, the closure 78
extends both annularly and axially about the shaft 72 and the
plunger 74, and is slidably mounted thereon. The filling device 70
further includes a coil spring 86 mounted within the closure 78,
between a distal end of the plunger 74 and the distal surface 80 of
the closure. The spring 86 biases the closure in the direction from
the second or open position to the first or closed position to
normally close the ports 82. However, as may be recognized by those
of ordinary skill in the pertinent art based on the teachings
herein, the closure may be biased in any of numerous different ways
that are currently known or that later become known, and if a
spring is used, any of numerous different springs or combinations
of springs may be used. As also may be recognized by those of
ordinary skill in the pertinent art based on the teachings herein,
the closure may take any of numerous different configurations that
are currently known, or that later become known, for performing the
function of the closure as described herein.
[0067] As shown in the illustrated embodiment of FIGS. 6B and 6C,
the filling device 70 mates with the valve 10 to aseptically or
sterile fill fluids through the valve 10 and into the chamber 20 of
the container 18. In the illustrated embodiment, the filling device
70 is slidably engageable with the shell 12 of the valve 10. When
the distal surface 80 of the closure 78 engages the stop surface 62
of the vial body 14, the smooth tip 76 fully mates with the axially
extending socket 32. In the illustrated embodiment, the closure 78
of the filling device 70 is stabilized in part by the
axially-extending ledge 54 of the shell 12, when the distal surface
80 engages the stop surface 62. However, as may be recognized by
those of ordinary skill in the pertinent art based on the teachings
herein, the filling device 70 may engage the valve 10 in any of
numerous different ways, that are currently known or that later
become known, such as, for example, by snapping onto or into the
valve, or alternatively by threadedly connecting to the valve.
[0068] In the illustrated embodiment, the smooth tip 76 is defined
by a smooth bulbous tip which mates with the axially extending
socket 32. However, as may be recognized by those of ordinary skill
in the pertinent art based on the teachings herein, the filling
device tip and the axially extending socket of the valve may define
any of numerous other configurations that mate together, that are
currently known, or that later become known.
[0069] As shown in FIG. 6A, prior to mating with the valve 10, and
when the filling device tip 76 is exposed to the ambient
atmosphere, the closure 78 is in the closed position, wherein the
cylindrical shutter 84 is sealing the ports 82 with respect to
ambient atmosphere to thereby maintain the sterility of the ports
and of the interior of the filling device. As shown in FIG. 6B,
when the distal surface 80 of the closure 78 engages the stop
surface 62 and the tip 76 mates with the socket 32, the cylindrical
shutter 84 is interposed between the ports 82 and the septum 60 to
substantially prevent contact between the ports and the septum. In
this position, the stop surface 62 of the valve body 14 prevents
further axial movement of the closure 78 and the shutter 84.
Thereafter, when the plunger 74 is axially depressed, as shown in
FIG. 6C, the shaft 72 and the tip 76 move axially relative to the
closure 78 and the shutter 84, against the bias of the spring 86,
from the first, or closed, position to the second, or open,
position, thereby opening the ports 82. The tip 76 also
simultaneously displaces the flexible valve member 16 from the
closed position to the open position. In the open position of both
the ports 82 and the flexible valve member 16, fluid within the
filling device is permitted to flow through the open ports, through
the flow aperture(s) 58 in the valve seat 56 and through the flow
aperture(s) 38 in the lower portion 26 of flexible valve member 16,
and into the chamber 20. Since the sterile ports 82 are not exposed
to the ambient atmosphere, the ports, interior of the filling
device, and fluid flowing therethrough, are never contaminated
and/or are maintained sterile as the fluid is dispended into the
chamber 20.
[0070] After the chamber 20 is filled as desired, the steps shown
in FIGS. 6A-6C are generally reversed and the filling device 70 is
withdrawn from the valve 10. First the plunger 74 is released, and
the spring 86 naturally rebounds and biases the plunger 74, the
shaft 72 and the tip 76, away from the valve 10, in the direction
from the second position to the first position. Both the shaft 72
and the flexible valve member 16 return to their closed, sealed,
positions, where the shutter 84 again forms a substantially
fluid-tight seal between the ports 82 and the ambient atmosphere,
and the cylindrical sealing surface 28 of the flexible valve member
16 reengages the cylindrical valve seat 56 to form a fluid-tight
seal therebetween. Thereafter, the filling device 70 is withdrawn
and disengaged from the valve 10. Thus, during, upon, and, in some
embodiments, before withdrawal of the filling device 70 from the
valve 10, the shutter 84 recloses the ports 82 to prevent any
contamination of the ports 82 or interiors of the filling device,
and the flexible valve member 16 recloses to prevent any
contamination of the interior of the valve 10 and/or chamber
20.
[0071] One advantage of the present invention is that the filling
device, such as the cannula in the illustrated embodiment, defines
a smooth tip. This is safer for use than a filling device with a
sharp tip, which may cause injury. Further, the filling device does
not pierce through the stopper of the valve but rather depresses
the flexible valve member from a closed position to an open
position. Thus, there is no chance for any septum material to
dislodge and contaminate the substance within the attached
container or device. In addition, there is no resulting aperture
from penetration of the valve requiring resealing after the filling
device is disengaged. Rather, the filling device naturally springs
back into the closed and sealed position.
[0072] In FIGS. 7-11, another device is indicated generally by the
reference numeral 100. The connector 100 is substantially similar
to the valve 10 and filling device 70 described above in connection
with FIGS. 1-6, and therefore like reference numerals preceded by
the numeral "1" are used to indicate like elements. A primary
difference of the connector 100 in comparison to the valve 10 and
filling device 70, is that the valve 10 comprises a portion of a
first or female connector 110, and the filling device 70 comprises
a portion of a second or male connector 170, forming an aseptic
self-closing connector. An exemplary embodiment of an aseptic
self-closing connector is disclosed in co-pending U.S. patent
application Ser. No. 13/864,919, filed Apr. 17, 2013, entitled
"Self Closing Connector," which, in turn claims benefit of
similarly titled U.S. Provisional Application No. 61/625,663, filed
Apr. 17, 2012, U.S. Provisional Application No. 61/635,258, filed
Apr. 18, 2012, and U.S. Provisional Application No. 61/784,764,
filed Mar. 14, 2013, each of which is hereby expressly incorporated
by reference in its entirety as part of the present disclosure.
[0073] In the illustrated embodiment, the male connector 170
comprises a male shell 188, having a filling member 190, a closure
178, and a spring element 186. As shown in FIG. 10A, the male shell
188 comprises a central first hollow shaft 172, with a tip 176
formed at a dispensing end of the shaft, two ports 182, 182,
proximally displaced from the tip 176 of the shaft in fluid
communication with the interior of the first hollow shaft 172, and
a barbed fitting 192 protruding from the hollow shaft at an inlet
end thereof, for engaging a fluid line 101 (as shown in FIG. 7). In
the illustrated embodiment, the filling member tip 176 is defined
by a substantially bulbous tip; however, as may be recognized by
those of ordinary skill in the pertinent art based on the teachings
herein, the tip may define any of numerous other blunt or
substantially curvilinear tip configurations that are currently
known, or that later become known. In the illustrated embodiment,
the two ports 182 are diametrically opposed relative to each other;
however, as may be recognized by those of ordinary skill in the
pertinent art based on the teachings herein, the filling member may
define any number of ports that may define any of numerous
different configurations and locations. In the illustrated
embodiment, the filling member 190 is integrally molded with the
male shell 188; however, as may be recognized by those of ordinary
skill in the pertinent art based on the teachings herein, the
filling member may be fixedly attached to the male shell in any of
numerous other configurations that are currently known, or that
later becomes known.
[0074] As shown in FIG. 8, the male connector includes lugs 194
laterally extending outwardly from the male shell 188, for engaging
corresponding primary receiving slots 228 (shown in FIG. 9) in the
female connector 110, as described further below. The lugs 194 are
proximally offset from a distal end 196 of the male connector 170
that engages the female connector 110. The male connector also
defines axially-extending slots 198, extending from the distal end
196 of the male connector, as shown in FIG. 8, for receiving
therein an alignment tab 199 of the closure 178, as described
further below.
[0075] In the illustrated embodiment the cylindrical closure 178 is
mounted within the cylindrical male shell 188, and includes a
central cylindrical shutter 184, axially-extending from a rear wall
200 of the closure. The shutter 184 receives a portion of the
filling member 190 including the ports 182 and extends both
annularly and axially thereabout. The closure 178 is both rotatable
and axially moveable with respect to the male shell 188. The
closure 178 and/or the male shell 188 is axially movable between
(i) a first position wherein the shutter 184 closes the ports 182,
as shown typically in FIGS. 10A-10D, and (ii) a second position
opening the ports 182, as shown typically in FIGS. 10E-10F. In the
illustrated embodiment, the shutter 184 forms a substantially
fluid-tight seal between the ports 182 and ambient atmosphere when
in the first position. The closure 178, and thus the shutter 184,
is biased by the spring element 186 in the direction from the
second or open position to the first or closed position to normally
close the ports 182, thereby preventing exposure of the ports 182,
the interior of the first hollow shaft 172, and any fluid therein
to the ambient atmosphere.
[0076] The male connector 14 also includes ribs 202, projecting
inwardly from the interior wall of the male shell 188 and abutting
the rear wall 200 of the closure 178, to normally prevent the
closure from moving from the first position toward the second
position. The closure 178 includes corresponding slots 204
extending distally from the rear wall 200 thereof, for receiving
said ribs. Only when the ribs 202 align with the slots 204, can the
closure 178 axially move from the first position to the second
position. The male shell 188 and the closure 178 must first be
rotated with respect to one another, in order to align the ribs 202
with the slots 204, as explained further below.
[0077] As shown in FIG. 8 the closure 178 also includes the
alignment tab 199, integrally formed with and along the cylindrical
sidewall 206 of the closure, where a distal end of the alignment
tab 199 is substantially flush with a distal end of the closure
178. When the alignment tab 199 engages one of the
axially-extending slots 198 of the male shell 188, the closure and
the male shell cannot rotate with respect to one another, and
therefore the ribs 202 cannot be aligned with the slots 204.
However, when the tab 199 is biased inwardly and disengaged from
one of the slots 198, as described further below, the closure 178
and male shell 188 become rotatable with respect to one
another.
[0078] The closure 178 also includes axially-extending projections
208, projecting inwardly from the cylindrical side wall 206 of the
closure, for engaging secondary receiving slots 230 of the female
connector 110, as explained further below. In the illustrated
embodiment, the axially-extending projections 208, extend the
entire length of the closure sidewall 206, but in other embodiments
may not.
[0079] In the illustrated embodiment, as shown in FIGS. 10A-10F,
the male connector 170 includes a substantially dome shaped spring
element 186 that naturally biases the closure 178 in the direction
from the second or open position to the first or closed position.
As may be recognized by those of ordinary skill in the pertinent
art based on the teachings herein, the closure may be biased in any
of numerous different ways that are currently known or that later
become known, and if a spring is used, any of numerous different
springs or combinations of springs may be used, such as, for
example, a coil spring as described in the embodiment of FIGS. 1-6
above. The substantially dome shaped spring element 186 is located
within the male shell 110, extending between the rear wall of the
male shell 188 and the rear wall of the closure 178, and the first
hollow shaft 172 of the filling member 190 extends therethrough.
The sprint element 186 comprises a cylindrical portion 210, atop a
substantially dome-shaped portion 212. The cylindrical portion
includes an annular sealing recess 214, for sealingly receiving a
corresponding annular sealing projection 216 extending from of the
rear wall 200 of the closure 178. In the illustrated embodiment,
the spring element 186 is over molded onto the annular sealing
projection 216 of the closure 178, to ensure a substantially
fluid-tight seal between the cylindrical portion 210 of the spring
element and the closure.
[0080] The substantially dome-shaped portion 212 of the spring
element 186 is formed of a resilient and/or elastomeric material
defining an integral spring therein. The integral spring can be
manually compressed and maintained in the compressed state.
Otherwise, the integral spring naturally rebounds and biases the
closure 178 in a direction from the second or open position to the
first or closed position. At the junction of the cylindrical
portion 210 and the dome-shaped portion 212, the spring element 186
includes an inwardly-extending annular seal 218, sealingly engaging
and slideable relative to the first hollow shaft 172 and vice
versa. In the illustrated embodiment, the slideable seal is an
O-ring, integrally formed with the spring element 186. However, as
may be recognized by those of ordinary skill in the pertinent art
based on the teachings herein, the slideable seal may take the form
of any sealing member, currently known or that later becomes known,
capable of sliding along and sealingly engaging the hollow shaft of
the filling member and may not be integral with the spring
element.
[0081] As shown in FIGS. 10A-10F, the opposing base end of the
dome-shaped portion 212 includes an integrally formed annular
one-way venting valve 220, which engages the rear wall of the male
shell 188. The rear wall of the male shell includes corresponding
venting holes 222, normally sealed by the valve 220. When the
spring element 186 is compressed, the venting valve 220 displaces
from the holes 222 due to pressure inside the dome-shaped chamber
224, and allows the venting of air in a single direction out of the
chamber 224, out of the spring element 186, through the venting
holes 222 and into the ambient atmosphere. When the pressure
equalizes, the valve 220 resiliently returns to its sealing
position on the holes 222. Thereafter, in similar fashion, in order
to allow the spring element 186 to naturally rebound and not remain
in the compressed position, the venting valve 220 allows the
venting of air in a single direction through the venting holes 222,
when a vacuum is present in the spring element 186, and into the
chamber 224 of the spring element 186. As may be recognized by
those of ordinary skill in the pertinent art based on the teachings
herein, the one-way venting valve may take the form of any of
numerous integral or non-integral valves, that are currently known
or that later become known, capable of performing the function of
the venting valve as described herein.
[0082] As shown in FIG. 9, the female shell 226 comprises a central
second shaft 112, or a chamber, therein, which receives the
flexible valve member 116, the valve body 114 and the septum 160
therein, in the same manner as explained above with respect to the
embodiment of FIGS. 1-6. In the illustrated embodiment, the second
shaft or chamber 112 is integrally molded with the female shell
112; however, as may be recognized by those of ordinary skill in
the pertinent art based on the teachings herein, the second hollow
shaft may be fixedly attached to the female shell in any of
numerous other configurations that are currently known, or that
later become known. The second shaft 112 also includes an outwardly
extending barbed fitting 228 at an outlet end thereof for
connecting to a fluid line 102 (as shown in FIG. 7). As may be
recognized by those of ordinary skill in the pertinent art based on
the teachings herein, the second hollow shaft my include any of
numerous fittings, that are currently known or that later become
known, for engaging a fluid line.
[0083] As shown in FIG. 9, the female shell 226 further includes
primary and secondary receiving slots 228, 230, for engaging the
lugs 194 of the male shell 188 and the axially-extending
projections 208 of the closure 178, respectively. The primary
receiving slots 228 are part of the female shell 226 and the
secondary receiving slots 230 are formed on the central second
shaft 112. The secondary receiving slots 230 only extend axially.
The primary receiving slots 228, on the other hand, include a first
axially-extending portion 232, followed by a first substantially
horizontal portion 234 a second axially-extending portion 236, and
end with a second substantially horizontal portion 238. The first
axially-extending portion 232 consists substantially of an
outwardly projecting recess in the female shell wall.
Alternatively, the portion 232 could be a window. The first
substantially horizontal portion 234, second axially-extending
portion 236, and second substantially horizontal portion 238 of the
primary receiving slots 228 are formed by windows in the female
shell wall. However, the portions 234, 236, and 238 may also be
recesses.
[0084] As shown in FIG. 10A, a covering portion 240 is engageable
with the female connector 110 when the male and female connectors
are not connected. In the illustrated embodiment, the covering
portion 240 is a substantially cylindrical cap. However, as may be
recognized by those of ordinary skill in the pertinent art based on
the teachings herein, the covering portion may take the form of any
of numerous covering portions, configured to perform the function
of the covering portion as described herein. The covering portion
240 is configured to sealingly engage the female shell 226. The
covering portion 240 includes distal surface 242, which sealingly
engages the stop surface 162 of the valve body 114 when the
covering portion is placed on the female connector, and has a
central axially-extending projection 244 projecting therefrom,
configured to extend through the septum passageway 164 and mate
with the axially-extending socket 132 of the flexible valve member
116. The covering portion 240 further includes an annular sealing
surface 246, laterally projecting from an opposing proximal end of
the covering portion, configured to mount atop the upper rim of the
female shell 226 when the covering portion is placed on the female
connector 110.
[0085] As shown in FIGS. 10 and 11, the male and female connectors
are connectable for the aseptic transfer of fluid therethrough.
First, the covering portion 240 must be removed from engagement
with the female connector 110. Then, the male connector 170 and
female connector 110, which may be sterilized, are engaged, as
shown typically in FIGS. 10B and 11B. In order to engage the male
and female connectors, the alignment tab 199, must first align with
one of the primary slots 228, as shown typically in FIGS. 10B and
11B. Otherwise the tab will catch on the edge of the female shell,
and prevent engagement. The axially-extending projections 208 of
the closure 178 and the lugs 194 of the male shell 188 are
configured to also align with the primary and secondary slots 228,
230, respectively, when the alignment tab 199 aligns with one of
the primary slots 228. As shown typically in FIGS. 10C and 11C, the
male connector 170 is pressed further into engagement with the
female connector 110 until the lugs 194 reach the end of the first
axially-extending portion 232 of the primary slots 228, and the
axially-extending projections 208 reach the end of the secondary
slots 230. Because the lugs 194 are offset from the distal end of
male shell 188, whereas the alignment tab 199 is substantially
flush with the distal end of the closure 178, the alignment tab
will reach the end of the first axially-extending portion 232 of
the primary slots 228 prior to the lugs 194. Upon reaching this
point, the alignment tab 199 is biased inwardly at the first
substantially horizontal portion 234, and continues to slide
against the inside of sidewall of the female shell 226 until the
lugs 194 reach the end of the first axially-extending portion.
[0086] As the lugs 194 move down the first axially-extending
portion 232 of the primary slots 228, the tip 176 of the filling
member 190 correspondingly passes through the septum passageway
164. As shown typically in FIGS. 10A-10B prior to passage through
the septum 160, the shutter 184 is in the closed position and
cannot be opened, thereby sealing the ports 182 with respect to
ambient atmosphere to maintain the sterility of the ports and of
the interior of the filling member 190. As shown typically in FIG.
10C-10D, during passage through the septum 160 the shutter 184
remains in the closed position, and is still interposed between the
ports 182 and the septum 160 to substantially prevent contact
between the ports and the septum. The tip 176 of the filling member
190 engages the axially-extending socket 132 of the flexible valve
member 116 when the lugs 194 reach the end of the first
axially-extending portion 232, as shown in FIG. 10C.
[0087] The male connector 170 is thereafter rotated to move the
lugs 194 along the first substantially horizontal portion 234 of
the primary slots 228, as shown in FIGS. 10D and 11D. Since the
secondary slots 230 are solely axially-extending, and the
axially-extending projections 208 of the closure 178 are engaged
with the secondary slots 208, the closure 178 is prevented from
also rotating relative to the female connector 110. However,
because the alignment tab 199 of the closure 178 has been inwardly
biased, thereby disengaging the tab from the corresponding
axially-extending slot 198 of the male shell 188, the male shell is
now rotatable relative to the closure 178. Consequently, the male
shell 188, along with the filling member 190, rotates with respect
to the stationary closure 178. Since the filling member 190 is only
rotated in this step, and not moved further axially, the shutter
184 remains in the closed position, continuing to seal the ports
182 with respect to ambient atmosphere and to maintain the
sterility of the ports and of the interior of the filling member
190.
[0088] Upon rotation to the end of the first substantially
horizontal portion 234 of the primary slots 228, the ribs 202 of
the male shell 188 and the corresponding slots 204 extending from
the rear wall of the closure 178 align. Only then can the closure
and/or the male shell be moved axially relative to one another to
move the ports 182 into the second or open position. The male
connector 170 is thus pressed into further axial engagement with
the female connector 110, and the lugs 194 move down the second
axially-extending portion 236, as shown in FIGS. 10E and 11E. Since
the axially-extending projections 208 of the closure 178 have
already reached the end of the secondary slots 230, the closure is
prevented from further axial movement relative to the septum 160.
Consequently, as the male shell 188 moves further into engagement
with the female shell 226, as shown in FIG. 10E, the filling member
190 depresses the flexible valve member 116 from the closed
position, where the valve seat 156 sealingly engages the sealing
surface 128 of the flexible valve member, into the open position,
where the sealing surface 128 is moved out of engagement with the
valve seat 156. The closure 178 remains in place and compresses
spring element 186, to, in turn, move the ports 182 past the end of
the shutter 184 into the second or open position. As the ports are
now past the septum, the septum seals the ports from the ambient
atmosphere.
[0089] Upon reaching the end of the second axially-extending
portion 236 of the primary slots 228, the male connector 170 is
rotated again to slide the lugs 194 along the second substantially
horizontal portion 238 of the primary slots, as shown in FIGS. 10F
and 11F, to releasably lock the male and female connectors with the
ports 182 in the second or open position, i.e., cannot be
withdrawn, and the flexible valve member 116 in the open position.
Alternatively, the portion 238 may not be present. In the open
position of FIGS. 10F and 11F, fluid may travel from a fluid line
101, through the filling member 190, through the open ports 182,
through the flow aperture(s) 158 in the valve seat 156, through the
flow aperture(s) 138 of the flexible valve member 116, into the
second shaft/chamber 112 of the female connector 110 and continuing
to the fluid line 102. Since the sterile ports 182 are never
exposed to the ambient atmosphere, the ports, interior of the
filling member, and fluid flowing therethrough, are not
contaminated and/or are maintained sterile as the fluid passes
therethrough to the female connector 110.
[0090] To disconnect the male and female connectors 170, 110, the
connecting steps are generally reversed. First, the male connector
170 is rotated to slide the lugs 194 in the reverse direction along
the second substantially horizontal portion 238 (if present) of the
primary slots 228, thereby unlocking the ports 182 from the open
position. Upon reaching the opposing end of the second
substantially horizontal portion and subsequent movement along
portion 236, the spring element 186 naturally rebounds to return
the ports 182 from the open position into the normally closed
position, wherein the ports are again sealingly covered by the
shutter 184. The shutter 184 remains interposed between the ports
182 and the septum 160 and therefore substantially prevents contact
between the ports and the septum. The closed position is thereafter
maintained, e.g., by the bias of the spring element 186 throughout
the remainder of the disconnection process. Also as the lugs 194
move along the portion 236, the spring 136 of the flexible valve
member 116 likewise simultaneously naturally rebounds to return the
flexible valve member 116 from the open position, back into the
normally closed position, where the sealing surface 128 thereof
reengages the valve seat 156, and reseals the interior of the
second shaft 112 and any fluid therein from the ambient atmosphere.
The lugs 194 are moved back up the second axially-extending portion
236 of the primary slots 228 with the natural rebound of the sprint
elements 136 and 186. Thereafter, the male connector 170 is rotated
to move the lugs 194 along the first substantially horizontal
portion 234 of the primary slots 228, returning the male connector
170 to its original configuration. The male connector 170 is then
pulled out of engagement from the female connector 110, thereby
withdrawing the tip 176 of the filling member 190 from the septum
160 and withdrawing the lugs 194 and the axially-extending
projections 208 from the first axially-extending portion of the
primary slots 228 and the secondary slots 230 respectively. The
covering portion 240 may then be reengaged with the female
connector 110.
[0091] The shutter 184 remains closed over the ports 182 and
prevents contact between the ports and the septum 160 during
withdrawal therefrom. Thus, during and upon, and in some
embodiments, before, withdrawal of the filling member 190 from the
septum 160, the shutter 184 maintains the ports 182 in the closed
position and cannot be opened, thereby preventing any contamination
of the ports or interior of the filling member.
[0092] The process may then be repeated whereby the male and female
connectors are re-connected to aseptically transfer fluid
therethrough once again. In some embodiments, the tip 176 of the
filling member 190 may be re-sterilized prior to repeating
connection of the two connectors. Sterilization and
re-sterilization of the male and female connectors and/or any
component parts therein may be achieved in accordance with the
teachings 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. 08/424,932, filed Apr. 19, 1995, entitled "Process for
Filling a Sealed Receptacle under Aseptic Conditions," issued as
U.S. Pat. No. 5,641,004; U.S. patent application Ser. No.
09/781,846, filed Feb. 12, 2001, entitled "Medicament Vial Having a
Heat-Sealable Cap, and Apparatus and Method for Filling Vial,"
issued as U.S. Pat. No. 6,604,561, which, in turn, claims benefit
of U.S. Provisional Patent Application No. 60/182,139, filed Feb.
11, 2000, entitled "Heat-Sealable Cap for Medicament Vial;" U.S.
patent application Ser. No. 10/655,455, filed Sep. 3, 2003,
entitled "Sealed Containers and Methods of Making and Filling
Same," issued as U.S. Pat. No. 7,100,646, which, in turn, claims
benefit of similarly titled U.S. Provisional Patent Application No.
60/408,068, filed Sep. 3, 2002; U.S. patent application Ser. No.
10/766,172, filed Jan. 28, 2004, entitled "Medicament Vial Having a
Heat-Sealable Cap, and Apparatus and Method for Filling the Vial,"
issued as U.S. Pat. No. 7,032,631, which, in turn claims benefit of
similarly titled U.S. Provisional Patent Application No.
60/443,526, filed Jan. 28, 2003 and similarly titled U.S.
Provisional Patent Application No. 60/484,204, filed Jun. 30, 2003;
and U.S. Provisional Patent Application No. 61/625,663, filed Apr.
17, 2012, entitled "Self Closing Connector."
[0093] In some embodiments, the septum 160 comprises a lower, i.e.,
base, layer having a relatively high durometer and an upper layer
having a relatively lower durometer. In some such embodiments, the
upper layer is not bondable with the lower layer and is over-molded
thereon. In some such embodiments, the septum 160 may wipe the tip
176 of the filling member 190 and the shutter 184, of contaminants
thereon during engagement and passage through the septum 160 by the
tip 176, to prevent the tip and/or shutter from introducing such
contaminants into the sterile interior of the female connector 110.
The effectiveness of such wiping during piercing of the septum is
dependent upon several factors, such as, for example, the wall
thickness and durometer of the septum. In some embodiments, the
durometer of the septum 160, or the layers thereof, is within the
range of about 5 Shore A to about 65 Shore A, such as, for example,
within the range of about 20 Shore A to about 50 Shore A. In some
such embodiments, the durometer of the septum 160 is within the
range of about 25 Shore A to about 45 Shore A. In some such
embodiments the septum thickness is within the range of about 1/2
the diameter of the filling member to about double the largest
diameter of the filling member. The present inventor has determined
that the wiping effect on a tip surface by a septum having a wall
thickness and durometer within said aforementioned ranges may
achieve at least approximately a 3 log reduction in bio-burden when
the male and female connectors are connected while immersed in a
broth, which is about the reduction achieved by known UV pulse (5
second) sterilization techniques, to thereby at least partially
sterilize the tip surface. Therefore, one advantage of the present
invention is that it allows substantially sterile transfer of
fluids within a non-aseptic, non-sterile or relatively low
sterility assurance level ("SAL") environment (e.g., about 6 log
bio-burden or lower).
[0094] It should be noted that any portion of the tip 176 of the
filling member 190 that is not wiped by the septum 160 is never
exposed in the interior of the second shaft 112. The tip 176 is
sealingly engaged by the socket 132 prior to moving the flexible
valve member 116 from the sealingly closed position to the open
position, and remains in sealing engagement with the socket 132
throughout the entire time the flexible valve member 116 is in the
open position, until the flexible valve member rebounds back into
the sealingly closed position. Any portion of the tip 176 that is
not wiped by the septum is sealingly covered by the socket 132 and
never exposed to the interior of the second shaft 112. The tip 176
sealingly engages the socket 132, due to, in part, the
corresponding shape of the socket 132 with respect to the shape of
the tip 176 along with the downward directed force applied to the
filling member 190 to engage the socket 132 in conjunction with the
opposing upward directed spring force of the spring 136 of the
flexible valve member.
[0095] In FIGS. 12-13B, another device is indicated generally by
the reference numeral 300. The device 300 is substantially similar
to the valve 10 and the connector 100 described above in connection
with FIGS. 1-6, and 7-11, respectively. Therefore like reference
numerals preceded by the numeral "3" are used to indicate like
elements. As shown in FIG. 12, the device 300 comprises a bladder,
bag, or pouch 318 defining a variable-volume storage chamber 320
therein and having first and second ports 319, 310, respectively,
connected in fluid communication therewith.
[0096] As shown in FIG. 12, the first port 319 includes a
penetrable and resealable septum 319a that is penetrable by a
needle, filling or injection member (not shown) for sterile or
aseptically filling the storage chamber 320 with substance to be
stored therein. The septum 319a, 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 319a 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 320 from the ambient atmosphere and thereby
maintain the sterility of the substance.
[0097] For example, the septum 319a may be penetrable for sterile
filling the variable-volume storage chamber 320 and resealable,
such as by the application of laser, other radiation, or thermal
energy, to hermetically seal the filled substance within the
storage chamber 320 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 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 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 Apr. 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. Pat. 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."
[0098] Alternatively, the septum 319a may be penetrable for sterile
filling the variable-volume storage chamber 320 and resealable with
a liquid sealant, such as a silicone sealant, to hermetically seal
the filled substance within the storage chamber 320, 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."
[0099] In the illustrated embodiment, the second port 310 is
defined by a substantially cylindrical first shell 326 attached at
a base end thereof to the pouch 318, and a second shell 327 secured
at a base end thereof to the upper end of the first shell 326. The
first shell 326 comprises a first hollow shaft 312a in fluid
communication with the pouch 318 and a second, approximately
central, hollow shaft 312b within the first hollow shaft. The upper
end of the first shaft 312a (in the orientation in FIG. 12) is
approximately flush with the upper end of the first shell 326. The
second shaft 312b extends into the second shell 327.
[0100] The second shell includes a substantially cylindrical base
portion 327a (secured to the first shell 326), a substantially
cylindrical mid-portion 327b of different diameter, and an outer
connector portion 327c of different diameter. In the illustrated
embodiment, the connector portion 327c includes a male LUER
connector. However, the connector portion 327c can take any
suitable form of a connector, as should be appreciated by those of
ordinary skill in the art. The outer portion 327c has a smaller
diameter than the mid-portion 327b and therefore a first annular
lip/shoulder 327d is defined at the interface therebetween. The
mid-portion 310b has a smaller diameter than the base portion 310a,
and therefore a second annular lip/shoulder 327e is formed at the
interface therebetween. The diameter of the base portion 327a is
substantially equal to the diameter of the first shell 326. The
diameter of the mid-portion 327b is substantially equal to the
diameter of the first shaft 312a. The first shell 326 and second
shell 327 can be sealingly joined.
[0101] A septum or seat 360 is fittingly mounted into the outer
portion 327c. In the illustrated embodiment, the septum 360 is
over-molded or otherwise co-molded to the outer portion 327c, and
an annular base thereof 360a is sealingly engaged with the
corresponding annular lip 327d. The outer surface of the septum 360
is substantially flush with the outer surface of the outer portion
327c, and the septum 360 defines a septum passageway 364
therethrough. Similar to the embodiments above, the septum 360 is
formed of an elastomeric material. However, as should be recognized
by those of ordinary skill in the pertinent art based on the
teachings herein, the septum may be formed of any of numerous
different materials that are currently known, or that later become
known, for performing the function of the septum or seat as
described herein.
[0102] The second port 310 further includes a plunger 325 therein.
The plunger 325 comprises a substantially hollow barrel 329, having
an open base end 329a, and an upper surface 329b. The open base end
329a is slidably received within the first shaft 312a, and thus the
inside of the barrel 329 is in fluid communication with the first
shaft 312a, and, in turn, with the storage chamber 320. An
approximately central elongated tip 316 extends from the upper
surface 329a of the barrel 329. An approximately central member 317
extends from the upper surface 329b into barrel 329, and in sliding
engagement with the second shaft 312b. The upper surface 329b of
the barrel 329 defines at least one fluid-flow aperture 338
therein.
[0103] As shown in FIG. 13A, the barrel 329 further includes a
first annular sealing member 329c, adjacent the upper surface 329b
thereof, that sealingly engages the interior surface of the
mid-portion 327b side-wall. The first annular seal 329c forms an
interference fit with the substantially cylindrical interior
surface of the mid-portion 327b and thereby forms a fluid-tight
seal therebetween. The barrel 329 also includes a second annular
sealing member 329d, adjacent the base end 329a thereof, that
sealingly engages the interior surface of first shaft 312a
side-wall. The second annular seal 329d forms an interference fit
with the substantially cylindrical interior surface of the first
shaft 312a and thereby forms a fluid-tight seal therebetween. In
the illustrated embodiment, the sealing members 329c, 329d are
formed by o-rings. Alternatively, the sealing members may be
integrally formed with barrel 329, such as by forming annular
protuberances thereon.
[0104] The plunger 325 is sealingly and slidably movable within the
first shaft 312a of the first shell 326 and the second shell 327
between (i) a first position, as shown in FIG. 13A, wherein the
elongated tip 316 extends through the passageway 364 of septum 360
and forms a seal therewith, and (ii) a second position, as shown in
FIG. 13B, wherein the elongated tip 316 is retracted or displaced
from the septum 360 and does not extend through or seal the
passageway 364. Thus, in the first position, the tip 316 and the
septum 360 define a closed, sealed, valve. The elongated tip 316
engages the septum 360 and forms a fluid-tight seal between the
aperture(s) 338 and the ambient atmosphere, thereby closing the
aperture(s) 338 from fluid flow therethrough. In some embodiments
the septum 360 forms an interference fit with the tip 316 to
thereby form the fluid-tight seal therebetween in the first
position. Such interference fit is sufficiently small, though, to
permit the elongated tip 316 to slide relative to the septum 360.
The upper surface 329b of the barrel 329 also defines an annular
spike 329e extending around the tip 316 that sealingly engages into
the base end 360a of the elastomeric septum 360 in the first
position for stabilization.
[0105] In the second position, the retracted tip 316 and the septum
360 define an open valve. As the tip 316 is spaced away from the
passageway 364, and the upper surface 329b of the barrel 329 is
spaced away from the base 360a of the septum 360, the aperture(s)
338 is placed in fluid communication with the opened passageway 364
for fluid flow therethrough.
[0106] The plunger 325 is biased in the direction from the second
or open position to the first or closed position to normally close
the aperture(s) 338. In the illustrated embodiment, the second port
310 includes a coil spring 336 that biases the plunger 325 in the
direction from the second or open position to the first or closed
position. The spring 336 encircles both the first shaft 312a and
the barrel 329, and is mounted between the base end of the first
shell 326 and a laterally-extending projection 329f of the barrel
329. The barrel 329 and second shell 327 are dimensioned such that
in the first position, the projection 329f abuts the internal
surface of the lip 327e, and in the second position the projection
329f abuts a stop surface 312c of the first shaft 312a. As may be
recognized by those of ordinary skill in the pertinent art based on
the teachings herein, the plunger 325 may be biased in any of
numerous different ways that are currently known or that later
become known, using biasing members other than springs, and if a
spring is used, any of numerous different springs or combinations
of springs may be used, e.g., a dome-shaped spring.
[0107] As shown in FIGS. 13A and 13B, a syringe or other delivery
device 370 mates with the second port 310 to aseptically or sterile
transfer fluids between the device 370 and the storage chamber 320.
In the illustrated embodiment, the delivery device 370 has a female
Luer connector 371 at the distal end thereof, for mating with the
male Luer connector 327c. The delivery device connector 371 defines
an elongated hollow shaft 371a therein dimensioned to fit into the
passageway 364 that engages the elongated tip 316 of the plunger
325 and, in turn, displaces the tip 316 and plunger 352, against
the bias of the spring, from the first position to the second
position during connection of the delivery device 370 to the
connector 327c. Similar to the embodiments described above, the
septum 360 may wipe the shaft 371a of the delivery device 370, of
contaminants thereon during engagement and passage through the
septum passageway 364 by the shaft 371a, to prevent the shaft from
introducing such contaminants into the sterile interior of the
sealed second port 310.
[0108] When the syringe 370 is fully connected to the connector
327c and thus the plunger 325 is in the second position (FIG. 13B),
fluid can flow between the delivery device 370 and the storage
chamber 320. In the case of the illustrated LUER connector, the
male connector portion is threaded into the female connector
portion, the resulting relative axial movement of the delivery
device, specifically the shaft 371a, relative to the device 300,
depresses or retracts the plunger 352 and thereby the tip 316 out
of the passageway. It should be noted that the length of the
passageway is less than the length of the shaft 371a so that upon
full engagement of the delivery device 370 and device 300, the tip
316 is fully retracted out of the passageway, so as to define a
fluid pathway between the delivery device 370 and the device 330
via the shaft hollow 371a, the passageway 364, the interior of the
mid portion 327b, and the aperture(s) 338. For example, the
delivery device 370 can dispense fluid through the hollow shaft
371c thereof, through the fluid-flow aperture(s) 338 and the barrel
329, through the first shaft 312a and, in turn, into the storage
chamber 320. Conversely, the pouch 318 may be hung, such that when
the plunger 325 is displaced into the second position by a delivery
device 370, fluid may flow out of the storage chamber 320, through
the first shaft 312a, the barrel 329 and out the fluid-flow
aperture(s) 338, and, in turn, through the shaft 371a and into the
device 370.
[0109] After the desired volume of fluid is transferred between the
device 300 and the delivery device 370, the delivery device is
disconnected (e.g., unthreaded) from the connector 327c. As the
shaft 371a is withdrawn from the septum passageway 364, the spring
336 biases the plunger 325 and the tip 316 back into sealing
engagement with the septum 360, to, in turn, maintain the sterility
of the interior of the device 300.
[0110] 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 appended claims. For example, the
components of the valve and filling device and/or the male and
female connectors may be made of any of numerous different rigid or
flexible materials that are currently known or that later become
known for performing the functions of the various components. The
valve and filling device may also be used with any of numerous
different devices or containers, such as vials, syringes or other
dispensers, or alternatively as part of a line, such as in a
hospital environment for example. Further, the filing device and/or
sealed empty device to be filled may be sterilized prior to filling
with a fluid sterilant as disclosed in U.S. Provisional Patent
Application No. 61/499,626, filed Jun. 21, 2011, entitled "Nitric
Oxide Injection Sterilization Device and Method," which is hereby
expressly incorporated by reference in its entirety as part of the
present disclosure as if fully set forth herein. Accordingly, this
detailed description of embodiments is to be taken in an
illustrative, as opposed to a limiting sense.
* * * * *