U.S. patent application number 10/143038 was filed with the patent office on 2002-12-12 for fluid transfer devices and methods of use.
This patent application is currently assigned to Nexell Therapeutics, Inc.. Invention is credited to Ettefagh, Guity, Juliar, Rena.
Application Number | 20020185186 10/143038 |
Document ID | / |
Family ID | 23111493 |
Filed Date | 2002-12-12 |
United States Patent
Application |
20020185186 |
Kind Code |
A1 |
Juliar, Rena ; et
al. |
December 12, 2002 |
Fluid transfer devices and methods of use
Abstract
A device and method of use are disclosed to facilitate fluid
transfers during sterile closed system processing procedures. The
device is configured to create connections for the transfer of
fluid between various components, along a closed sterile fluid
passageway and, eventually, either to a fluid container or to a
patient. As a result, the device and method of use of the present
invention reduce the risk of contamination to the fluids, such as
reagents, medicaments and cellular products, and increase user or
technician safety during processing procedures.
Inventors: |
Juliar, Rena; (Corona,
CA) ; Ettefagh, Guity; (Anaheim, CA) |
Correspondence
Address: |
OPPENHEIMER WOLFF & DONNELLY LLP
840 NEWPORT CENTER DRIVE
SUITE 700
NEWPORT BEACH
CA
92660
US
|
Assignee: |
Nexell Therapeutics, Inc.
|
Family ID: |
23111493 |
Appl. No.: |
10/143038 |
Filed: |
May 7, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60289429 |
May 8, 2001 |
|
|
|
Current U.S.
Class: |
138/96R |
Current CPC
Class: |
A61M 1/3693 20130101;
A61M 1/0231 20140204; A61M 39/10 20130101; A61M 39/14 20130101;
B01L 3/50825 20130101; A61M 39/165 20130101; A61M 39/045 20130101;
A61M 2205/0266 20130101; A61M 1/0001 20130101; B01L 3/5021
20130101 |
Class at
Publication: |
138/96.00R |
International
Class: |
B65D 059/00 |
Claims
what is claimed is:
1. A fluid transfer device comprising: a cap-shaped device
including a first port and a second port; a filtration vent
extending from said first port, wherein said filtration vent
filters air passing through said filtration vent; and a tubing
segment assembly extending from said second port and forming a
passageway for fluid transfers.
2. The device of claim 1 wherein said passageway is a closed fluid
pathway.
3. The device of claim 1 wherein said cap-shaped device is
configured for attachment to a rigid container.
4. The device of claim 3 wherein said container is a centrifugation
container.
5. The device of claim 1 wherein said cap-shaped device is
configured for attachment to a conical tube.
6. The device of claim 5 wherein said attachment is permanent.
7. The device of claim 5 wherein said attachment is removable.
8. The device of claim 5 wherein said conical tube is a
centrifugation tube.
9. The device of claim 1 further comprising a second tubing segment
extending from said second port within an interior portion of said
cap-shaped device.
10. The device of claim 1 wherein said cap-shaped device is
prefabricated onto a container and provided as an integral
device.
11. A method of transferring fluids into or out of a container
comprising: removing a cap from a container while under a laminar
flow hood; installing a cap-shaped device onto said container;
transferring said container to a general laboratory environment;
and connecting a closed system set to a tubing segment assembly of
said cap-shaped device, whereby a fluid may be transferred into or
out of said container in a closed system fluid pathway.
12. The method of claim 11 further comprising: inverting said
container, whereby fluid flows in a closed system fluid pathway
from said container to said closed system set via gravity.
13. The method of claim 11 further comprising: transferring a fluid
from said closed system set into said container.
14. The method of claim 13 further comprising: centrifuging said
fluid within said container; and removing a portion of said fluid
from said container.
15. The method of claim 14 further comprising: connecting a closed
system set to a tubing segment assembly of said cap-shaped device,
whereby a fluid may be transferred into or out of said container in
a closed system fluid pathway.
16. The method of claim 11 further comprising: pumping a fluid from
said container through a second tubing segment of said cap-shaped
device, through said tubing segment assembly and into said closed
system set.
17. A method of transferring fluids into or out of a container
comprising: adding a fluid to a container via a cap-shaped device
of said container in a general laboratory environment, wherein a
fluid pathway of said container and cap-shaped device is a closed
system fluid pathway; centrifuging said fluid within said
container; and removing a portion of said fluid from said container
while maintaining said closed system fluid pathway.
18. The method of claim 17 further comprising: connecting a closed
system set to a tubing segment assembly of said cap-shaped device,
whereby a fluid may be transferred into or out of said container in
a closed system fluid pathway.
19. The method of claim 18 further comprising: connecting a
receiving container to said closed system set; positioning said
receiving container a sufficient distance below said container; and
aspirating said fluid from said container to said receiving
container.
20. The method of claim 19 further comprising: tipping said
container to remove any residual fluid from said container.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional
Patent Application No. 60/289,429, filed May 8, 2001, whose
contents are fully incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The medical industry utilizes a wide variety of solution
containers, container caps, connectors and tubing sets to create
connections for the transfer of fluid between various components,
along a fluid passageway and, eventually, either to a fluid
container or to a patient. Examples of such connections include,
but are not limited to, the processing of blood and its fractions,
mixing of sterile solutions and connecting Foley catheters with
urinary drainage bags. In order to maintain the sterility of the
fluid pathway and minimize the risk to the operator (e.g., needle
sticks, biohazard exposure, etc.), these connections should be
designed to be closed (i.e., without open exposure of the fluid
pathway to air).
[0003] In closed system cellular processing, for example, single
use sterile disposable sets (e.g., bags, tubing, etc.) are joined
together to enable the closed handling of biological fluids. One or
more access points into sterile disposable sets are key to user
convenience and system flexibility in closed system processing. All
additions and removal of fluid (e.g., sampling, etc.) and
connections of sets or other components for a next processing step
are made via these access points. Access points are typically
terminal tubing connectors such as luer fittings, spike couplers
and bag ports (e.g., spikable membrane ports).
[0004] Luer connectors are widely used in the medical industry for
making a connection between medical devices to establish a fluid
passageway. In general, a luer connection assembly includes a male
luer tip component or fitting having a frustoconical shape that is
inserted into a female luer component or fitting having a
frustoconically shaped receiving cavity. The opposing conical
surfaces of the luer fittings come into contact and form a sealed
friction fit assembly.
[0005] These connection assemblies and associated components are
typically packaged in sterile packaging and include caps or
protectors to maintain the sterility of the fluid pathway prior to
use. However, at the time the actual connection between components
is made, the fluid contacting surfaces and passageways are open to
the environment. As a result, these connections must frequently be
made inside a laminar flow hood to mitigate the fluid contamination
risk.
[0006] Another example of an access point or terminal connector is
a spike coupler. A tubing set having a spike coupler as its
terminal connector may be fluidly connected to a bag having a
spikable membrane port. In general, a spike coupler assembly
includes a spike component having a needle-like shape with a
beveled tip that is inserted into a spikable membrane port
generally having a cylindrically shaped receiving cavity or
opening. The opposing surfaces of the spike coupler and membrane
port come into contact and form a sealed friction fit assembly. The
spike coupler is used to access the contents of the bag through the
membrane port. When the spike is inserted into the port, the
membrane is broken causing the fluid to flow from the container
through the spike and into the tubing set. In contrast to the
above-described luer connectors, sets joined via spike couplers and
spikable membrane ports maintain an aseptic fluid pathway. This
processing system has the advantages of reduced potential for
contamination of the contained fluid and reduced potential for
operator exposure to the biohazards presented by such fluids.
[0007] Common problems or drawbacks associated with more
complicated processing using sets with spike couplers include
exceeding the number of available access points on a particular
disposable set or similar component. In these situations, it is
often necessary to transfer the fluid to a new set in order to
increase accessibility. Moreover, sets or containers having
incompatible terminal connectors, such as both sets terminating in
spike couplers, further adds to the difficulties encountered during
more complicated processing and may render the closed system fluid
transfer process an impossibility altogether.
[0008] In view of the foregoing, it would be desirable to have a
unitary one-piece adapter or connector which enables the connection
of two incompatible spike couplers. The adapter should also include
an integral cover to maintain sterility when the adapter is not in
use. As such, it is also desirable that the lumen and/or passageway
through the adapter that forms a portion of the fluid passageway be
sterile prior to use and maintain sterility, such as by being
sealed against microbial ingress, during connection and
disconnection of the spike couplers.
[0009] It is a further object of the present invention to provide a
connector which is capable of being manufactured at high speeds and
low cost. Generally the lower the number of parts making up a
component, the lower the number of required molds and high speed
assembly devices, both of which generally translate to lower
capital expenditures and therefore lower costs. It is a related
object of the present invention to provide a connector which may be
manufactured with a very low number of potential defects.
[0010] Depending on the application, many other features may also
be desirable. Dead spaces or voids within the connector which
cannot be "flushed" and in which stagnant fluid can collect to form
a media for microbial growth should be minimized or eliminated. It
is a related object of the present invention to provide a connector
which forms a sealed fluid path such that a minimum number of
microbes enter the fluid path during operation using aseptic
techniques. Also, priming volume for the connector should be
minimized.
[0011] It is still a further object of the present invention to
provide a connector which minimizes or eliminates flow restrictions
for the flow of fluid through the connector. It is another object
of the present invention to provide a connector device which is
capable of providing for a large number of connections and
disconnects while maintaining the ability to seal against fluids
under pressures typically found in an administration set.
[0012] For some processing procedures, it is necessary to transfer
the fluid from a manufacturer provided open container, such as a
bottle, to a differently configured closed container, such as a
bag, to perform the closed system processing procedure. In this
instance the user must pipette or decant the bottle contents into
the secondary container inside of a laminar flow hood. This is an
open and laborious process which, as a consequence, increases the
potential for contamination of the fluid and exposure to the
operator. In this instance, there is a need for a coupler that will
facilitate the transfer in a closed and sterile fashion.
[0013] An analogous need also exists in open system centrifugation
separation procedures. It is common in the medical, cell processing
and other fields to separate cells from suspending fluids via
centrifugation. This operation is typically required when washing
cells. The fluid component of the separation is aspirated or
decanted from the pellet of cells resulting from the applied
centrifugal forces. While sample volumes of 500 ml or greater may
be washed in bags using closed automated systems currently
available on the market, smaller volumes are typically washed using
commercially available open conical tubes. This is due to the cell
loss associated with bag use. In particular, cells become trapped
along the seams of bags and the flexible materials/structure of
bags cause their contents to move during handling, thereby
dislodging the cells from their concentrated pellet formation.
Therefore, a connector or system that enables the integration of
rigid open vessels with closed flexible containers is needed.
[0014] Although rigid containers overcome these shortcomings
typically associated with flexible bags, the use of rigid
containers requires access to air. This is due to the fact that it
is not possible to add or subtract fluids from such a container and
maintain a constant volume inside the rigid closed container.
Typically, a volume of air is needed to compensate for
removed/added fluids. For example, the removal of 200 ml of fluid
results in the addition of an equal amount of air into the
container and, thereby, into contact with the fluid path. As a
result, the addition of air into the container potentially
increases the risk of fluid and system contamination. Therefore, a
connector or system that enables the addition and/or release of
air/gases into a container without increasing the risk of fluid and
system contamination and operator exposure is needed.
BRIEF SUMMARY OF THE INVENTION
[0015] In view of the foregoing, it is an object of the present
invention to provide a connector or cap-shaped device that is
capable of being manufactured at high speeds and low cost.
[0016] It is a further object of the present invention to provide a
connector or cap-shaped device which may be manufactured with a
very low number of potential defects.
[0017] It is a further object of the present invention to provide a
connector or cap-shaped device which forms a sealed fluid path such
that a minimum number of microbes enter the fluid path during
operation using aseptic techniques.
[0018] It is a further object of the present invention to provide a
connector or cap-shaped device which minimizes or eliminates flow
restrictions for the flow of fluid through the connector.
[0019] It is a further object of the present invention to provide a
connector or cap-shaped device which is capable of providing for a
large number of connections and disconnects while maintaining the
ability to seal against fluids under pressures typically found in
an administration set.
[0020] It is a further object of the present invention to provide a
coupler or cap-shaped device that will facilitate the transfer of
fluids in a closed sterile fashion.
[0021] It is a further object of the present invention to provide a
connector or system that enables the integration of rigid open
vessels with closed flexible containers.
[0022] It is a further object of the present invention to provide a
connector or system that enables the addition and/or release of
air/gases into a container without increasing the risk of fluid and
system contamination and operator exposure.
[0023] These and other objects not specifically enumerated her are
addressed by the present invention which in at least one embodiment
may include a fluid transfer device that includes a cap-shaped
device including a first port and a second port. The device may
further include a filtration vent extending from the first port,
wherein the filtration vent filters air passing through the
filtration vent, and a tubing segment assembly extending from the
second port and forming a passageway for fluid transfers. In
general, the passageway formed by the device is a closed fluid
pathway. In addition, the device may be configured for attachment
to a container, such as a rigid container, bottle, conical tube,
centrifugation tube, centrifugation container, etc., or
prefabricated onto a container and provided as an integral
device.
[0024] The present invention may further include a method of
transferring fluids into and out of a container comprising removing
a cap form a container while under a laminar flow hood and
installing a cap-shaped device onto the container. The method may
also include transferring the container to a general laboratory
environment and connecting a closed system set to a tubing segment
assembly of the cap-shaped device, whereby a fluid may be
transferred into or out of said container in a closed system fluid
pathway. The method may further include transferring a fluid from
the closed system set into the container, centrifuging the fluid
and removing a portion of the fluid from the container.
[0025] In an alternate embodiment, the method may include pumping a
fluid from a container through a second tubing segment of the
cap-shaped device, through a tubing segment assembly and into a
closed system set.
[0026] A further embodiment of the present invention may include a
method of transferring fluids into or out of a container comprising
addling a fluid to a container via a cap-shaped device of the
container in a general laboratory environment, wherein a fluid
pathway of the container and cap-shaped device is a closed system
fluid pathway. The method may also include centrifuging the fluid
within the container and removing a portion of the fluid from the
container while maintaining the closed system fluid pathway. The
method may further include connecting a receiving container to the
closed system set, positioning the receiving container a sufficient
distance below the container and aspirating fluid from the
container to the receiving container.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] Other features and advantages of the present invention will
be seen as the following description of particular embodiments
progresses in conjunction with the drawings, in which:
[0028] FIG. 1 is a perspective view of a dual port membrane adapter
device in accordance with an embodiment of the present
invention;
[0029] FIG. 2 is illustrates the assembly and internal components
of the adapter device in accordance with an embodiment of the
present invention;
[0030] FIG. 3 is an end view of the adapter device in accordance
with an embodiment of the present invention;
[0031] FIG. 4 is an end view of an alternate embodiment of the
device of the present invention;
[0032] FIG. 5 is a sectional view of the adapter device in
accordance with an embodiment of the present invention;
[0033] FIG. 6 illustrates a cap-shaped device in accordance with an
embodiment of the present invention;
[0034] FIG. 7 is a perspective view of the cap-shaped device in
accordance with an embodiment of the present invention;
[0035] FIG. 8 is an alternate view of the cap-shaped device in
accordance with an embodiment of the present invention;
[0036] FIG. 9 illustrates an alternate embodiment of the cap-shaped
device in accordance with the present invention;
[0037] FIG. 10 illustrates a method of using the adapter in
accordance with an embodiment of the present invention; and
[0038] FIG. 11 illustrates a method of using the cap-shaped device
in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0039] The following description and figures are meant to be
illustrative only and not limiting. Other embodiments of this
invention will be apparent to those of ordinary skill in the art in
view of this description.
[0040] Referring to FIG. 1, an embodiment of a fluid transfer
device in accordance with the present invention includes a
connector or adapter 10 having a first cylindrically shaped conduit
12, a second cylindrically shaped conduit 14, and a hollow,
cylindrically shaped sleeve 16 located between the first and second
conduits 12, 14 of the adapter 10. Each conduit 12, 14 and the
sleeve 16 include a first end, a second end and a passageway
extending therebetween for the passage of fluid. The conduits 12,
14 and sleeve 16 are aligned along the same longitudinal axis 13
and are configured in fluid flow relationship with each other.
[0041] In one embodiment of the device, the first end 18 of the
first conduit 12 includes a fluid inlet port 20 and the second end
22 of the second conduit 14 includes a fluid outlet port 24.
Alternatively, the first end 18 of the first conduit 12 may include
a fluid outlet port 20 and the second end 22 of the second conduit
14 may include a fluid inlet port 24. In general, the conduits 12,
14 are configured for quick connection for releasably engaging a
terminal end, such as a spike coupler, of a tubing set.
[0042] As shown in FIGS. 1, 2 and 3, each conduit 12, 14 is
approximately 1.00.+-.0.05 inch (25.40.+-.1.27 mm) in length LC.
The tubular wall 26 forming the structure or framework of each
conduit 12, 14 may include a smooth internal surface 28, a smooth
external surface 30 and a wall thickness TC. In one embodiment of
the adapter 10, the wall thickness TC, internal diameter IDC and
external diameter EDC of each conduit are approximately within the
range of 0.030.+-.0.005 inch (0.762.+-.0.127 mm), 0.190.+-.0.005
inch (4.826.+-.0.127 mm) and 0.250.+-.0.005 inch (6.350.+-.0.127
mm), respectively. The diameters and wall thickness may either be
uniform or variable along the longitudinal length of each conduit
12, 14. A particular choice of wall thickness, diameters and length
depends on the configuration of the mating terminal end intended
for connection to the adapter 10. In other words, the configuration
of each conduit 12, 14 can vary according to the intended
procedure, mating connection and usage.
[0043] Similarly, the dimensional configuration of the sleeve 16 of
the adapter 10 should be appropriately sized to surround and
overlap portions of the conduits 12, 14 and to provide a sufficient
flow path for connecting devices (e.g., tubing set spike couplers).
In one embodiment, the length LS of the device sleeve 16 may be
approximately within the range of 1.50.+-.0.05 inch (38.10.+-.1.27
mm). In addition, the overlap portions 32 of the conduits 12, 14
and sleeve 16 may each be within the range of 0.25.+-.0.05 inch
(6.35.+-.1.27 mm).
[0044] The tubular wall 34 forming the structure of the sleeve 16
may include a smooth internal surface 36, a smooth external surface
38 and a wall thickness TS. In one embodiment, the wall thickness
TS, internal diameter IDS and external diameter EDS of the sleeve
16 are approximately within the range of 0.030.+-.0.005 inch
(0.762.+-.0.127 mm), 0.245.+-.0.005 inch (6.223.+-.0.127 mm) and
0.305.+-.0.005 inch (7.747.+-.0.127 mm), respectively. As with the
conduits 12, 14, the diameters and wall thickness of the sleeve 16
may either be uniform or variable along the length of the sleeve.
In general, the internal diameter IDS of at least a portion of the
sleeve 16 should be appropriately sized to match at least a portion
of the external diameter EDC of each conduit 12, 14 to ensure that
there is a snug and conforming fit and contact between the opposing
external and internal surfaces 30, 36 of each conduit 12, 14 and
sleeve 16, respectively. Further, the internal diameters of both
the conduits 12, 14 and sleeve 16 should be large enough to
adequately support an unrestricted flow of fluid therethrough.
Overall, the design of the adapter 10 should facilitate the
connection of tubing lines that terminate in spike couplers.
[0045] In an alternate embodiment of the invention (not shown), the
opposing external and internal surfaces 30, 36 of each conduit 12,
14 and sleeve 16, respectively, may be textured to increase the
surface area and, thereby, further enhance the contact
characteristics of the surfaces of the friction fit assembly 10. In
yet another embodiment of the device 10, the opposing external and
internal surfaces 30, 36 of each conduit 12, 14 and sleeve 16,
respectively, may be threaded for threaded engagement between the
components of the adapter 10. Alternative engagement features and
configurations including, but not limited to, ridges, channels,
grooves, bumps, indents, prongs, rods, tabs, flanges, chamfers, and
threads are also included within the scope of the claimed
invention.
[0046] The conduits 12, 14 and sleeve 16 of the adapter 10 may be
further secured together via ultrasonic welding. Additional
techniques and methods used to secure together the components of
the assembly 10 include, but are not limited to, frictional
welding, chemical bonding, heat shrinking, and fusing. These and
other techniques and methods not specifically disclosed herein but
known to those skilled in the art are also included within the
scope of the claimed invention.
[0047] In addition to the particular dimensional attributes of the
conduits 12, 14 and sleeve 16, the material characteristics of the
adapter 10 are also important to achieve the desired performance
features of the device 10. A variety of materials may be used to
fabricate the adapter 10 of the present invention. These materials
include, but are not limited to, plastics (e.g., polyethylene,
polyvinyl chloride, polycarbonate, etc.), silicone, stainless
steel, metals, and ceramics, including combinations thereof. In
general, the adapter materials should be sterilizable,
biocompatible and non-pyrogenic.
[0048] Although the adapter 10 may be constructed as a rigid,
flexible or semi-flexible connector, it is preferred that the
materials together with the structural design of the adapter 10
provide sufficient strength and structural integrity to avoid
kinking, collapse or restriction of the closed fluid flow path of
the conduits 12, 14 and sleeve 16. In one embodiment of the
invention, the adapter 10 may be configured as single use,
disposable connector. Alternatively, the adapter 10 may be
configured as a multiple use and re-sterilizable device.
[0049] Referring to FIGS. 2 and 3, each conduit 12, 14 of the
adapter 10 includes a transverse diaphragm or membrane 40 adapted
for breakage by a spike coupler from a tubing set. The membrane 40
may be located anywhere along the longitudinal length of the
conduits 12, 14 and, preferably, is located near the mid-section of
each conduit 12, 14. In one embodiment of the invention, the
membrane 40 is located approximately within the range of .+-.0.125
inch (.+-.3.1750 mm) from an end 42 of the sleeve 16 when the
conduit 12, 14 is housed within the sleeve 16. As a result, the two
membranes 40 of the adapter 10 form a closed chamber that extends
along the length LS of the sleeve 16 and a portion 42 of the length
LC of each conduit 12, 14.
[0050] In one embodiment of the invention, the membrane 40 is
formed as a solid, resilient barrier capable of being pierced or
broken when a terminal connector (e.g., spike coupler) is properly
seated within the adapter 10. In an alternate embodiment, shown in
FIG. 4, the membrane 40 may include one or more slits 44 forming a
valve-like element capable of being re-sealed in its closed
configuration. For example, when a spike coupler penetrates the
membrane 40, the slit(s) 44 spread apart and form an opening in the
membrane 40 that substantially surrounds a portion of the spike
coupler. The resulting connection between the spike coupler of the
tubing set and the conduit 12, 14 of the adapter 10 forms a closed
fluid pathway, thereby minimizing, if not altogether eliminating,
contamination risks. When the spike coupler is removed or
disconnected from the adapter 10, the slit(s) 44 return to their
original closed configuration and, essentially, re-seal the opening
in the membrane 40. As such, the adapter 10, particularly the
chamber of the adapter 10, maintains a continuous, closed,
contamination-free system that seals the fluid passageway from the
environment before, during and after a connection is formed.
[0051] Each membrane 40 of the present invention may be fabricated
from essentially the same materials of the conduits 12, 14 and
sleeve 16, as previously described. In an alternate embodiment, the
membranes 40, conduits 12, 14 and/or sleeve 16 of the device 10 may
be fabricated from dissimilar materials. In a preferred embodiment,
the membrane material is resilient and includes
memory-characteristics that enable the membrane to return to its
original configuration after use and adequately seal the fluid path
of the system.
[0052] As shown in FIG. 5, the adapter 10 of the present invention
may include one or more covers or tip protectors 46 to shield the
fluid inlet port and fluid outlet port of the conduits 12, 14 from
damage and contamination risks. These protectors maintain the
sterility of the membrane portion of the connector during storage
and up to the time of use.
[0053] As noted in the Background of the Invention as set forth
above, in addition to connectors, other types of fluid transfer
devices used in the medical industry include container caps and
closed container devices. Referring to FIG. 6, a cap-shaped device
in accordance with the present invention may include a sterile
filtration vent 52 and a tubing segment assembly 54. In general,
the cap-shaped device 50 includes a cylindrical neck 56 and a
substantially planar surface 58 positioned perpendicular to the
longitudinal axis 53 of the neck 56 and device 50.
[0054] To accommodate a variety of processing procedures and
container configurations, the cap-shaped device 50 may be
configured as a rigid or semi-flexible component. In one
embodiment, the cylindrical neck 56 of the device 50 is configured
for attachment to a bottle, conical tube, or other fixed volume
fluid container. However, it should be noted that alternate
configurations of the neck 56 including, but not limited to,
square-shaped, oval, and polygonal are known in the art and, as
such, are also included within the scope of the claimed
invention.
[0055] Two or more access ports or openings 60 are provided on the
surface 58 of the device 50, as shown in FIG. 7. In one embodiment
of the invention, a sterile filtration vent 52 may extend from the
first access port 60 and a tubing segment assembly 54 may extend
from the second access port 60. Referring to FIG. 6, the sterile
filtration vent 52 may include a sterile, tubular or luer-shaped
element 62 having a filter (not shown) located within the interior
cavity of the element 62. Before ambient air may enter or leave the
system, it must first pass through the filer of the vent 52. As
such, the sterile filtration vent 52 accomplishes several goals of
the present invention. First, by filtering ambient air before it
enters the system, the sterile filtration vent 52 maintains system
sterility and reduces the probability of fluid and system
contamination. In addition, since entrapped gases/air must also
pass through the filter before leaving the system, user exposure to
such potentially toxic and harmful gases/air is significantly
reduced or completely eliminated by virtue of the vent 52. Further,
with respect to fluid transfer operations using rigid containers,
the sterile filtration vent 52 allows air and gases to enter/escape
through the vent 52 and into/out of the closed rigid container to
compensate for removed/added fluids, while maintaining sterility of
the system via the filter.
[0056] Referring to FIGS. 6 and 8, the tubing segment assembly 54
of the device 50 of the present invention may include a segment of
tubing 64 and a sterile tubular or luer-shaped element 66. A first
end 68 of the luer-shaped element 66 may extend from the second
access port 60 of the device 50 and a second end 70 of the
luer-shaped element 66 may be in communication with a first end 72
of the tubing segment 64. Extending from the second end (not shown)
of the tubing segment 64 may be a terminal end of another closed
system sterile disposable set used to access to the contents of the
container.
[0057] In one embodiment of the invention, a second tubing segment
74 may also extend from the second access port 60 and/or first end
68 of the luer-shaped element 66 within the interior portion 76 of
the cap-shaped device 50, as shown in FIG. 8. This second tubing
segment 74 may be used as a straw or wick to access the contents of
the container during use of the device 50, as further described
below. Depending on the particular function or procedure, the
length of the second tubing segment may vary. For example, in a
large volume bottle cap, the tube 74 may extend to the bottom of
the bottle and be configured with a beveled or other similar
non-blunt end. This design would facilitate removal of the contents
by pumping when the container is in an upright position.
[0058] Analogously, when the cap-shaped device 50 is fitted onto a
centrifuge tube with a conical bottom, the second tubing segment 74
may extend to varying levels or depths towards the conical bottom.
In essence, the level or lengths of the second tubing segment 74
dictates the lowest level of fluid which may be aspirated from a
container.
[0059] In an alternate embodiment, the second tubing segment 74 may
extend through the second access port 60 of the device 50 (not
shown). For this embodiment, the second tubing segment 74 may be
mated to the cap 50 in such a way as to enable a hermetic seal
while allowing for user manipulation of tubing depth within the
container to thereby access a variety of fluid levels.
[0060] As with the adapter 10, the connector or cap-shaped device
50 of the present invention may be fabricated from a variety of
materials, such as those previously described herein. In general,
the device materials should be sterilizable, biocompatible and
non-pyrogenic. Together with the materials, the particular
dimensional characteristics of the device 50 should be optimized to
achieve the desired performance features of the device 50, such as
desired fluid flow rates and sufficient venting. In particular, the
vent 52 may be configured to include an adequate flow-through and
filtration area to enable free fluid flow from the tube 54. In
addition, the tubing segments 64, 74 may be configured as flexible,
semi-flexible or rigid components, depending upon the desired
performance characteristics of the device 50. Generally, in the
field of closed system cellular processing, the device 50 should be
configured to allow fluid transfers and processing to be conducted
in the open laboratory environment, without the risk of
contaminating the reagents and cellular products and exposing
technicians to contamination during the procedure.
[0061] In one embodiment of the invention, the cap-shaped device 50
may be supplied to users in several conventional container (e.g.,
bottle, bag, tube, etc.) bottle sizes to accommodate a variety of
bottled reagents. In another embodiment, the cap 50 may be
pre-fabricated onto a container and provided as an integral device.
In this regard, FIG. 9 depicts an example of what this embodiment
of a capped-container device 78 may look like in accordance with
the present invention. In essence, the device 78 includes the
cap-shaped device 50 and a container 79.
[0062] Although the container 79 depicted in FIG. 9 is a conical
tube, any of a variety of containers including, but not limited to,
bottles and bags may be used and are also included within the scope
of the claimed invention. In one embodiment, this container 79 may
be supplied in an unfilled or empty state to enable user
addition/subtraction of fluid. In addition, the cap-shaped device
50 may be either permanently or removably attached to the container
79. In an alternate embodiment, the container 79 may be supplied
pre-filled with a solution, reagent or other desired fluid to
bypass the need for cap placement entirely. Similar to the previous
embodiment, the pre-filled cap-shaped device 50 may be either
permanently or removably attached to the container 79.
[0063] Method of Use
[0064] In one embodiment of the invention, the double membrane port
adapter 10 may be used in closed system cellular processing. As
shown in FIG. 10, one step of a typical cellular processing
procedure may require two single use sterile disposable sets (e.g.,
tubing sets terminating in spike couplers) to be joined together
for a fluid transfer operation. To join the sets, a spike coupler
80 of a first tubing set is inserted along the longitudinal axis of
the adapter 10, through a port 20 and into a first conduit 12 of
the device 10. The spike coupler 80 is then advanced further within
the conduit 12 until at least the tip 82 of the spike coupler
penetrates through the membrane 40 of the conduit 12 and the spike
coupler 80 is properly seated within the adapter 10. At this point
in the procedure, the fluid pathway of the first tubing set remains
in a closed, sealed configuration due to the unbroken membrane 40
of the second conduit 14 of the adapter 10.
[0065] Next, a spike coupler 84 of a second tubing set is inserted
along the longitudinal axis of the adapter, through a port 24 and
into a second conduit 14 of the device 10. The spike coupler 84 is
then advanced further within the conduit 14 until at least the tip
86 of the spike coupler 84 penetrates through the membrane 40 of
the conduit 14 and the spike coupler 84 is properly seated within
the adapter 10 (not shown). Penetration of the second spike coupler
84 through the membrane 40 of the second conduit 14 creates a
closed, continuous, aseptic fluid pathway and, thereby, enables
fluid to be transferred via the sets.
[0066] Closed system cellular processing methods may also require
the transfer of fluid into or out of containers. In this instance,
a cap-shaped device 50 may be used to provide added convenience for
the user and processing flexibility. During use, a user of the
device 50 would replace the manufacturer provided cap on a
container with the cap-shaped device 50 of the present invention
while under a laminar flow hood. As shown in FIG. 11, the capped
container 88 could then be removed to the general laboratory
environment, where all fluid transfers of the processing procedure
may be performed while using the device 50. Next, the tubing
segment 64 on the cap-shaped device 50 could be connected to other
closed system sterile disposable sets 90. As a result, fluid could
then be transferred from the bottle 88 to the closed system sterile
disposable set 90 through the tubing segment 64 via gravity by
inversion of the bottle 88. In addition, if a rigid container is
used, a volume of ambient air will enter the container/bottle 88
via the sterile filtration vent 52 to replace the lost volume of
fluid during the fluid transfer operation. As such, the tubing
segment assembly 54 forms a closed system fluid pathway, together
with the filtration vent 52, for maintaining the sterility of the
system.
[0067] In an alternate embodiment, the fluid may be pumped out of
the bottle 88, through the tubing segment 64 and into the
disposable set 90. In yet another embodiment of the invention, the
cap-shaped device 50 may be configured with a second tubing segment
74 inside the bottle. As a result, the bottle 88 could remain in an
upright position and the fluid could be pumped out of the bottle 88
via the second tubing segment 74, through the tubing segment 64 and
into the disposable set 90.
[0068] As a further convenience for the user and means to maintain
system sterility, the processing procedure may be carried out using
the cap-shaped device 50 configured onto a conical shaped
tube/container 79, as shown in FIG. 9. During the processing
procedure, a cell suspension may be added to the container 79 by
connecting the tubing segment 64 to another closed sterile set. The
device 78 would be sealed (reversibly or irreversibly) and the
whole apparatus 78 placed into a centrifuge. Next, the apparatus 78
would be centrifuged resulting in pelletization of the heavier
cells or other particles from the fluid. After centrifugation, the
apparatus 78 would be removed from the centrifuge and another
connection would be made to the tubing segment 64, typically via an
alternate distal connector. The fluid portion of the suspension may
then be aspirated via the second tubing segment 74 into a closed
receiving container (not shown) via gravity and capillary action.
This process of aspirating the fluid from the container 79 may be
accomplished by placing the receiving container a sufficient
distance below the conical shaped tube 79 to draw off the fluid.
Residual fluid in the bottom of the container 79 may be aspirated
by slightly tipping the container 79 and without disturbing the
cell pellet.
[0069] As previously described, the length of the second tubing
segment 74 may be configured as desired to remain near the level of
a cell pellet, yet not allow cells to become lodged there during
centrifugation. It is clear that the tubing length might be longer
to accommodate tubes of greater length. In additional embodiments
of the invention, caps 50 (or full assemblies 78) may be made with
different tubing lengths. As such, the user would simply decide
which embodiment to use based on the chosen application.
[0070] In view of the foregoing, the cap-shaped device 50, 78 of
the present invention facilitates the addition of the bottled
reagent or fluid to closed sets and, thereby, reduces overall costs
of processing procedures. In addition, the device 50, 78 enables
processing in an open laboratory environment by providing a closed
system fluid path that reduces the risk of contamination to the
reagents and cellular products and increases user or technician
safety during processing procedures. In particular, the device 50,
78 reduces the potential of exposure of the operator to potentially
biohazardous materials.
[0071] Although the invention has been described in terms of
particular embodiments and applications, one of ordinary skill in
the art, in light of this teaching, can generate additional
embodiments and modifications without departing from the spirit of
or exceeding the scope of the claimed invention. Accordingly, it is
to be understood that the drawings and descriptions herein are
proffered by way of example to facilitate comprehension of the
invention and should not be construed to limit the scope
thereof.
* * * * *