U.S. patent application number 13/537363 was filed with the patent office on 2014-01-02 for medicament admixing system.
This patent application is currently assigned to HOSPIRA, INC.. The applicant listed for this patent is Jesse C. Darley, Yei F. Moy, Stanley F. Pytel, Douglas S. Rodenkirch, John S. Ziegler. Invention is credited to Jesse C. Darley, Yei F. Moy, Stanley F. Pytel, Douglas S. Rodenkirch, John S. Ziegler.
Application Number | 20140001063 13/537363 |
Document ID | / |
Family ID | 49777006 |
Filed Date | 2014-01-02 |
United States Patent
Application |
20140001063 |
Kind Code |
A1 |
Moy; Yei F. ; et
al. |
January 2, 2014 |
MEDICAMENT ADMIXING SYSTEM
Abstract
A port assembly for connecting a first container to a second
container and mixing the contents of the first container with the
contents of the second container. The port assembly has a port
housing that is configured to receive a first container. The port
assembly further includes an actuator axially fixed within a cavity
of the port housing. The actuator is configured to open the first
container by forcing a stopper sealing an opening of the first
container into a cavity of the first container during
activation.
Inventors: |
Moy; Yei F.; (Buffalo Grove,
IL) ; Pytel; Stanley F.; (Third Lake, IL) ;
Ziegler; John S.; (Arlington Heights, IL) ; Darley;
Jesse C.; (Madison, WI) ; Rodenkirch; Douglas S.;
(Sun Prairie, WI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Moy; Yei F.
Pytel; Stanley F.
Ziegler; John S.
Darley; Jesse C.
Rodenkirch; Douglas S. |
Buffalo Grove
Third Lake
Arlington Heights
Madison
Sun Prairie |
IL
IL
IL
WI
WI |
US
US
US
US
US |
|
|
Assignee: |
HOSPIRA, INC.
Lake Forest
IL
|
Family ID: |
49777006 |
Appl. No.: |
13/537363 |
Filed: |
June 29, 2012 |
Current U.S.
Class: |
206/219 |
Current CPC
Class: |
A61J 1/2041 20150501;
A61J 1/2055 20150501; A61J 1/10 20130101; A61J 1/2089 20130101 |
Class at
Publication: |
206/219 |
International
Class: |
B65D 25/04 20060101
B65D025/04 |
Claims
1. A port assembly for connecting a first container to a second
container and mixing contents of the first container with contents
of the second container, the port assembly comprising: a port
housing configured to receive a first container; an actuator
axially fixed within a cavity of the port housing, wherein the
actuator is configured to open the first container by forcing a
stopper sealing an opening of the first container into a cavity of
the first container during activation; and a moveable plug that
provides a seal between the cavity of the port housing and a cavity
of a second container when the port assembly is attached to the
second container.
2. The port assembly of claim 1, wherein the moveable plug is
configured to move axially relative to the actuator during
activation, thereby opening the seal between the cavity of the port
housing and the cavity of the second container and providing fluid
communication between the first container and the second
container.
3. The port assembly of claim 1, further comprising a mating member
positioned in the cavity of the port housing for docking the first
container to the port assembly.
4. The port assembly of claim 3, wherein the mating member
comprises a plurality of tabs.
5. The port assembly of claim 1, wherein the port assembly is
attached to the second container, and wherein the second container
is flexible and constructed of a polymeric material.
6. The port assembly of claim 1, wherein the actuator comprises a
plurality of sidewall members.
7. The port assembly of claim 6, wherein the plurality of sidewall
members define a central cavity of the actuator.
8. A port assembly for connecting a first container to a second
container and mixing contents of the first container with contents
of the second container, the port assembly comprising: a port
housing configured to receive a first container; an actuator
axially fixed within a cavity of the port housing, wherein the
actuator is configured to open the first container by forcing a
stopper sealing an opening of the first container into a cavity of
the first container during activation; and a moveable plug that
provides a seal between the cavity of the port housing and a cavity
of a second container when the port assembly is attached to the
second container, wherein the moveable plug comprises a seal member
and a plurality of legs extending away from the seal member.
9. The port assembly of claim 8, wherein the moveable plug is
configured to move axially relative to the actuator during
activation, thereby opening the seal between the cavity of the port
housing and the cavity of the second container and providing fluid
communication between the first container and the second
container.
10. The port assembly of claim 9, wherein axial movement of the
first container relative to the second container causes the
moveable plug to move axially relative to the actuator during
activation, thereby opening the seal between the cavity of the port
housing and the cavity of the second container and providing fluid
communication between the first container and the second
container.
11. The port assembly of claim 10, wherein the plurality of legs of
the moveable plug are configured to engage the first container when
the first container moves axially relative to the second container
during activation of the system.
12. The port assembly of claim 8, further comprising a mating
member positioned in the cavity of the port housing for docking the
first container to the port assembly.
13. The port assembly of claim 12, wherein the mating member
comprises a plurality of tabs.
14. The port assembly of claim 8, wherein the port assembly is
attached to the second container, and wherein the second container
is flexible and constructed of a polymeric material.
15. The port assembly of claim 8, wherein the actuator comprises a
plurality of side-wall members.
16. The port assembly of claim 15, wherein the plurality sidewall
members define a central cavity of the actuator.
17. A port assembly for connecting a first container to a second
container and mixing contents of the first container with contents
of the second container, the port assembly comprising: a port
housing configured to receive a first container; and an actuator
axially fixed within a cavity of the port housing, wherein the
actuator is configured to open the first container by forcing a
stopper sealing an opening of the first container into a cavity of
the first container during activation.
18. The port assembly of claim 17, further comprising a moveable
plug that provides a seal between the cavity of the port housing
and a cavity of a second container when the port assembly is
attached to the second container.
19. The port assembly of claim 18, wherein the moveable plug
comprises a seal member and a plurality of legs extending away from
the seal member.
20. The port assembly of claim 18, wherein axial movement of the
first container relative to the second container causes the
moveable plug to move axially relative to the actuator during
activation, thereby opening the seal between the cavity of the port
housing and the cavity of the second container and providing fluid
communication between the first container and the second container.
Description
TECHNICAL FIELD
[0001] The invention relates generally to a system and method for
mixing the contents of two containers, and more particularly to a
system for mixing or reconstituting a medicament contained in a
first container with a diluent contained in a second container.
BACKGROUND OF THE INVENTION
[0002] Medicaments or drugs administered in a health care
environment are typically packaged in vials whose interior is
maintained in a sterile condition. The vials themselves are sealed
by a sterile stopper which is typically pierced by a cannula when
it is desired to remove the medicament or drug. Several procedures
are required to get the drug from the vial into the body of a
patient. Each procedure potentially jeopardizes the sterility of
the vial, the stopper or the medicament. Further, if the medicament
in a particular vial is a powder or is concentrated, there is often
a need to add diluent to the vial to dissolve the powder or to
dilute the concentrated medicament solution to the desired
strength. Devices providing separate compartments in a single
container for separately enclosing different components in such as
way that they may be later intermixed are described in various U.S.
patents, including U.S. Pat. No. 2,176,923 to Nitardy; U.S. Pat.
No. 3,290,017 to Davies et al.; and, U.S. Pat. No. 3,532,254 to
Burke et al. Additional devices of this type are disclosed in other
U.S. patents, including U.S. Pat. No. 4,458,811 to Wilkinson: U.S.
Pat. No. 4,610,684 to Knox, et al.; U.S. Pat. No. 4,998,671 to
Lefheit; U.S. Pat. No. 5,102,408 to Hanacher: U.S. Pat. No.
5,176,526 to Barney, et al.; U.S. Pat. No. 5,462,526 to Barney, et
al.; U.S. Pat. No. 5,928,213 to Barney, et al.; U.S. Pat. No.
5,944,709 to Barney, et al.; U.S. Pat. No. 6,203,535 to Barney, et
al.; and U.S. Pat. No. 6,846,305 to Smith, et al.
[0003] Additionally, dual compartmented container systems having
the means to intermix the contents of the two containers are also
known in the art. For example, Hospira, Inc., the assignee of the
present invention, owns numerous patents relating to such
technology, including U.S. Pat. Nos. 4,614,267; 4,614,515;
4,757,911; 4,703,864; 4,784,658; 4,784,259; 4,948,000; 4,963,441;
and 5,064,059. Such delivery systems are manufactured and sold by
Hospira, Inc. under the ADD-VANTAGE.RTM. trademark.
[0004] Accordingly, reconstitution systems and systems to intermix
the contents of two containers from outside the container are well
known in the art. While such reconstitution systems according to
the prior art provide a number of advantageous features, they
nevertheless have certain limitations. The present invention seeks
to overcome certain of these limitations and other drawbacks of the
prior art, and to provide new features not heretofore available. A
full discussion of the features and advantages of the present
invention is deferred to the following detailed description, which
proceeds with reference to the accompanying drawings.
SUMMARY OF THE INVENTION
[0005] The present invention generally provides a system for mixing
or reconstituting a drug contained in a first container with a
diluent contained in a second container. In one embodiment the
first container has a body cap that engages a port assembly
connected to the second container to provide for fluid
communication between a cavity of the first container and a cavity
of the second container.
[0006] According to one embodiment, the first container is a drug
container. The drug container has a neck and an opening in the neck
leading to a cavity. A stopper is positioned within the opening of
the first container to close off access to the cavity of the first
container. The body cap is positioned around the neck and body
portions of the container body. The body cap has a first mating
member adapted to be received by a second mating member of the
second container for connecting the first container to the second
container. In one embodiment the first mating member comprises a
flange extending from the body cap.
[0007] According to another embodiment, the second container is a
diluent container, such as an IV bag. The diluent container has a
port assembly extending therefrom. The port assembly is designed to
receive the first container to place the contents of the first
container in fluid communication with the contents of the second
container.
[0008] According to another embodiment, the port assembly has a
first opening at a proximal end thereof providing access to a
cavity of the port housing, a second opening opposing the first
opening, and a moveable plug sealing the second opening. According
to another embodiment, the port housing has a second mating member
adapted to engage the first mating member of the first container
for connecting the second container to the first container. In one
embodiment the second mating member is a retainer having a
plurality of different length tabs to engage the first container in
different axial positions.
[0009] According to another embodiment, the first set of tabs are
utilized to assist in docking the first container in the port
housing, and preferably preventing the first container from being
removed from the port housing following docking, i.e., in a docked,
non-activated position. In another embodiment, the second set of
tabs is utilized to assist in maintaining the first container in an
activated position.
[0010] According to another embodiment, the stopper transitions
from a first position within the opening of the neck of the
container body, to a second position within the cavity of the
container body. When the stopper is in the second position
medicament can flow through the opening in the first container
[0011] According to another embodiment, the port assembly has an
integral actuator. The actuator is positioned within the cavity of
the port housing. In one embodiment, the actuator has a proximal
end, a distal end, and a central cavity. In another embodiment the
actuator is comprised of a plurality of axial sidewall members with
axial gaps between the sidewall members.
[0012] According to another embodiment, a system for mixing a
medicament in a first container with a sterile fluid in a second
container is provided. The system comprises an activation collar
connected to the first container.
[0013] According to another embodiment, the first container has a
recessed track on an outer surface thereof, and the activation
collar has a protrusion that mates with the track. The geometry of
the track dictates allowable movement of the first container.
[0014] According to another embodiment, a visual indicator is
provided on the outer surface of the first container. The visual
indicator is generally visible when the first container is in the
first or docked position. However, the visual indicator is
generally hidden within the port assembly when the first container
is in the second or activated position, thereby providing a
positive visual indication of activation.
[0015] Other features and advantages of the invention will be
apparent from the following specification taken in conjunction with
the following drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] To understand the present invention, it will now be
described by way of example, with reference to the accompanying
drawings in which:
[0017] FIG. 1 is a perspective view of one embodiment of the
presents invention in which a first container is docked to a second
container and activated to allow for reconstitution of a drug in
the first container with a diluent in the second container, with
the system shown in the hanging position for use;
[0018] FIG. 2 is a perspective view of one embodiment of a first
container in accordance with the present invention and a second
container in accordance with the present invention, the second
container having a docking port, the first and second containers
being depicted prior to docking and activation of the first
container to the second container;
[0019] FIG. 3 is a perspective exploded view of one embodiment of
the docking assembly for the second container in accordance with
the present invention;
[0020] FIG. 4 is an exploded perspective view of one embodiment of
the first container depicted in FIG. 1;
[0021] FIG. 5 is a front elevation view of the first container
shown in a simulated docked position;
[0022] FIG. 6 is a front elevation view of the first container
shown in a rotated position prior to final activation;
[0023] FIG. 7 is a front elevation view of the first container
shown in an activated position following simulated activation;
[0024] FIG. 8 is a cross-sectional view of the upper housing
assembly of the first container about the center-line thereof;
[0025] FIG. 9 is a cross-sectional view about the centerline of the
first container and second container prior to docking of the first
container;
[0026] FIG. 10 is a cross-sectional view about the centerline of
the first container and second container following docking of the
first container (i.e., in the docked position);
[0027] FIG. 11 is a cross-sectional view about the centerline of
the first container and second container during activation of the
first container;
[0028] FIG. 12 is a cross-sectional view about the centerline of
the first container and second container following activation of
the first container; and,
[0029] FIG. 13 is a perspective view of a method of utilizing a
syringe in connection with the medicament in the first
container.
DETAILED DESCRIPTION
[0030] While this invention is susceptible of embodiments in many
different forms, there is shown in the drawings and will herein be
described in detail preferred embodiments of the invention with the
understanding that the present disclosure is to be considered as an
exemplification of the principles of the invention and is not
intended to limit the broad aspect of the invention to the
embodiments illustrated.
[0031] Referring now to the Figures, and specifically to FIGS. 1
and 2, there is shown a two-part admixing or reconstitution system
410 comprised of a first container 412 and a second container 414.
In one embodiment, the first container 412 is a medicament or drug
container 412 and is preferably in the form of a vial with an
exterior housing, and the second container 414 is a diluent
container and is preferably in the form of a flexible bag. In a one
embodiment the diluent container 414 is a flexible container formed
from first and second opposing sheets of flexible material that are
joined and sealed at the edges to provide a fluid tight cavity for
containing a diluent therein. At one edge thereof, the opposing
sheets of the flexible diluent container 414 are sealed around the
port housing 482 of the port assembly 418 to fixedly connect the
port assembly 418 to the second container 414.
[0032] The first container 412 has an upper body member 416 or body
cap 416 that is adapted to mate with a retainer 486 in the port
assembly 418 of the second container 414, as depicted in FIG. 3.
The combination of body cap 416 and retainer 486 of the port
assembly 418 assist in docking the first container 412 to the
second container 414, and also assist in establishing a fluid
connection between the interiors of first container 412 and second
container 414 in order to enable mixing of the contents of the two
containers 412, 414. Typically, to mix or reconstitute the drug in
the first container 412, the first container 412 is docked or
connected to the port assembly 418 of the second container 414 as
shown in FIG. 10, and then the cavities of each container 412, 414
are placed in fluid communication via an activation process, as
shown in FIGS. 1 and 11-12, in order to mix the contents of first
and second containers 412, 414.
[0033] As shown in FIG. 4, in one embodiment the first container
412 is a vial containing a medicament or drug. The medicament or
drug can be in any number of different forms, including liquid,
gel, or powder (e.g., lyophilized) forms, or in a combination of
any of these known forms. The medicament or drug is depicted in
FIG. 4 as being a powdered or lyophilized drug. In this embodiment
the first container 412 is partially surrounded by a body cap 416,
a hanger cap 476 and a label 480. Connected to the body cap 416 is
a removable top cap 464 and an activation collar 438. Additionally,
as shown in FIG. 8, a seal ring 439 is provided. The seal ring 439
connects around the neck area 422 of first container 412, and is
adjacent the interior surface of removable top cap 464 prior to
removal of the top cap 464 from the body cap 416. The seal ring 439
prevents any of the diluent and/or medicament from escaping out of
the fluid flow path between the first container 412 and the second
container 414.
[0034] First container 412 can be in the form of a vial can be
constructed from a variety of known materials, including glasses,
plastics, and any other commercially acceptable materials. The
first container 412 generally has a body portion 420 and a neck 422
extending therefrom. The neck 422 of the first container 412
surrounds an opening 424 leading to an internal cavity 426 that
houses the contents, such as a medicament or drug, in the first
container 412. In one embodiment the neck 422 of the first
container 412 also has an outwardly extending annular portion 436
adjacent the opening 424 of the first container 412.
[0035] A stopper 428 is provided in the opening 424 of the first
container 412. Stopper 428 is operable to seal second container
414. The stopper 428 closes the opening 424 and prevents the
contents in the internal cavity 426 from escaping out of the cavity
426 of the first container 412. The stopper 428 also prevents
external components from unintentionally entering the cavity 426 of
the first container 412. The stopper 428 has a body portion 430
that is configured to be positioned within the neck 422 of the
first container 412, and a top surface 432 that is outwardly facing
from the neck 422 of the first container 412 when the stopper 428
is in the position shown in FIG. 9. In one embodiment the top
surface 432 of the stopper 428 has a depression 433 to assist in
reducing the forces necessary to transition the stopper 428 to a
second position within the first container 412. In an alternate
embodiment, there is no depression 433 in the top surface 432 of
the stopper 428. Additionally, in a preferred embodiment the
stopper 428 also has a flange 434 extending from the body portion
430. The flange 434 is beneficial for maintaining the stopper 428
placement in the first container 412 when a syringe or cannula is
inserted through stopper 428 to make solution additions and/or to
withdraw material from the first container 412, and for providing
an air and/or moisture seal when the first container 412 is
connected to the port assembly 418 of the second container 414. In
the embodiment depicted in FIG. 9, an undercut 429 is provided
about the circumference of stopper 428 at the point at which the
underside of flange 434 meets the stopper body portion 430.
Undercut 429 serves as a hinge or folding point to assist in
reducing the stopper push-in force, i.e., the force required to
push stopper 428 into the interior of first container 412 when the
system of the present invention is moved to the activated position.
Undercut 429 enables flange 434 to hinge or fold upwardly during
activation of the system. For example, in the position shown in
FIG. 9, the flange 434 of the stopper 428 rests on the top of the
outwardly extending annular portion 436 of the neck 422 of the
first container 412, i.e., flange 434 has been folded upwardly due
to the application of an inwardly directed activation force. In the
depicted embodiments of stopper 428, undercut 429 is in the form of
a groove having a width in the range of 0.03 inches to 0.1 inches.
In an alternative embodiment, the width of undercut 429 is in the
range of 0.04-0.07 inches. It will be appreciated by those of
ordinary skill in the art that the dimension and shape of undercut
429 will vary depending upon (a) the material from which stopper
428 is constructed; and (b) the target force required to push
stopper 428 into the interior of first container 412 when the
system of the present invention is activated, as described in
detail herein.
[0036] Referring to the exploded view and the cross-sectional view
of the first container 412 as shown in FIGS. 4 and 9, in one
embodiment the body cap 416 is generally positioned around the neck
portion'422 and the body portion 420 of the first container 412.
More specifically, the body cap 416 has an internal cavity 456 that
houses at least a portion of the body 420 of the first container
412. The body cap 416 thus generally covers the upper portion of
the first container 412 and assists in docking the first container
412 to the second container 414, as well as assisting in activating
the system 410.
[0037] As shown in FIGS. 4 and 9, the body cap 416 has a sidewall
442. A track 441 is provided in the sidewall 442 of the body cap
416. As explained herein, the track 441 guides the movement of the
first container 412 in combination with the activation collar 438
during the transition of the first container 412 from the docked
position to the activated position. In the embodiment depicted in
FIG. 4, track 441 is an indent or recess in the sidewall 442 of the
body cap 416. The track 441 is designed to receive a protrusion 479
extending from the activation collar 438 such that protrusion 479
can move therein. The track 441 has a first vertical portion 443, a
horizontal portion 445, and a second vertical portion 447. The
track 441 also has at least one defeatable stop 449. In one
embodiment a defeatable stop 449 is provided in the first vertical
portion 443. In an alternative embodiment, another defeatable stop
449 is provided in the horizontal portion 445 of the track 441. The
defeatable stop 449 operates to preclude movement of the activation
collar 438 by not allowing the protrusion 479 on the inner sidewall
of the activation collar 438 to pass over the defeatable stop 449
until a certain amount of force is applied, whereupon the stop is
"defeated" and further movement becomes possible. The first
vertical portion 443 of the track 441 is relatively short, and is
generally provided to allow for a small amount of movement in
overcoming the defeatable stop 449. Conversely, the second vertical
portion 447 of the track 441 is longer to allow for complete axial
movement of the first container 412 with respect to the second
container 414 which results in activation of the system 410, as
explained in detail below. The second vertical portion 447 of the
track 441 has an activation marker 485 which cooperates with the
activation marker 483 to provide a visual indication of proper
rotational alignment of the first container 412 for activation. The
horizontal portion 445 of the track 441 joins the first vertical
portion 443 and the second vertical portion 447 to provide a single
continuous track. The horizontal portion 445 allows for rotational
movement of the body cap 416 with respect to the activation collar
438 (which is maintained stationary via its splines 481 as
identified herein) such that the activation marker 485 on the body
cap 416 will align with activation marker 483 on the activation
collar 438 (see FIGS. 4-7). In an alternative embodiment, the body
cap 416 has first and second tracks 441 spaced 180.degree. apart on
the sidewall 442 of the body cap 416, and the activation collar 438
has mating first and second protrusions 479 spaced 180.degree.
apart. In another alternative embodiment, the body cap 416 has
first, second, and third tracks 441 spaced 120.degree. apart on the
sidewall 442 of the body cap 416 and the activation collar 438 has
mating first, second, and third protrusions 479 spaced 120.degree.
apart.
[0038] The body cap 416 also has a first mating member that engages
a second mating member of the port housing assembly 418. In a
preferred embodiment the first mating member of the body cap 416,
and thus first container 412, comprises first and second annular
flanges 450, 451 that extend radially outward from a distal portion
of the sidewall 442 of the body cap 416, as shown in FIGS. 4-8. The
first annular flange 450 is positioned adjacent the distal end of
the body cap 416, and the second annular flange 451 is positioned a
predetermined distance below the first annular flange 450. In one
embodiment, the first annular flange 450 of the first mating member
is utilized to assist in centering the first container 412 in the
port housing 482 (see FIGS. 9 and 10) and docking the first
container 412 to the port housing 482 in the docked position (see
FIG. 10). The second annular flange 451 of the first mating member
is utilized to assist in maintaining the first container 412 in the
fully activated position (see FIG. 12). In the depicted embodiments
of the present invention, the first and second annular flanges 450,
451 have circular circumferential perimeters that are sized and
shaped to fit within the opening to the retainer 486 of the port
housing 482, and to engage the tabs 520, 522 of the retainer 486 of
the port housing 482. In alternative embodiments, first and second
annular flanges 450, 451 have interrupted circumferential
perimeters, i.e., one or more gaps or voids are present about the
circumference.
[0039] As explained above, the top cap 464 of the body cap 416 is
removable. As shown in FIGS. 4 and 8, the top cap 464 has a pull
ring 465 associated therewith. The top cap 464 provides an integral
cap for the first container 412 that prevents the first container
412 from being docked to the second container 414 prior to removal
of the top cap 464, and it also protects the first container 412
from any attempted tampering by generally providing a protective
seal over the opening to the body cap 416 to seal the internal
cavity 456 of the body cap 416, including all components and
surfaces interior of the body cap 416, from the outside environment
and to provide sterility to the area in the interior of the body
cap 416. Thus, one cannot access the contents of the first
container 412 when the top cap 464 is still connected to the body
cap 416. The top cap 464 also has a circumferential rib 467 that
protrudes axially downward into the cavity of the body cap 416. As
shown in FIG. 8, the circumferential rib 467 engages an annular
depression 437 in the top of the seal ring 439 to assist in
properly aligning the first container 412 in the body cap 416. In
one embodiment, the body cap 416 and top cap 464 are manufactured
integrally from a low density polyethylene. It will be appreciated
that a variety of materials, and combinations of materials, can be
used in the manufacture of body cap 416 and top cap 464. A thin
wall 466 joins the top cap 464 to the body cap 416. The thin wall
466 can be ruptured to disconnect the top cap 464 from the body cap
416. To remove the top cap 464, the user pulls on the pull ring
465, which in turn ruptures the thin wall 466 connecting the top
cap 464 to the body cap 416, thereby disconnecting the top cap 464
from the remainder of the body cap 416 (see FIG. 9). Because thin
wall 466 is ruptured in the process of removing top cap 464 from
body cap 416, top cap 464 cannot be reattached, thus providing
evidence of possible tampering with the contents of first container
412.
[0040] Referring to FIG. 8, the body cap 416 also has first and
second rib seals 460. The rib seals 460 are preferably protrusions
extending radially inwardly from the interior surface of the body
cap 416 into the cavity 456 of the body cap 416 to engage the first
container 412 and provide a seal against contaminants entering the
cavity 456 of the body cap 416. In one embodiment each rib seal 460
is interrupted at approximately 180.degree. to allow for venting of
the cavity 456, however, the interruptions of the first rib seal
460 are offset 90.degree. from the interruptions of the second rib
seal 460 to provide an interrupted, tortuous path for the
preservation of sterility of the cavity 456 of the body cap 416 and
the contents thereof.
[0041] Seal ring 439 is configured to engage the neck area 422 of
the first container 412. As shown in FIG. 8, the seal ring 439
comprises a generally cylindrical component having a sidewall 453.
The sidewall 453 has a first flange 455 extending radially outward
from the sidewall 453 at an upper first end portion thereof, and a
second flange 459 extending radially inward from the sidewall 453
at a lower second end portion thereof. The seal ring 439 also has
an internal shoulder 463. The internal shoulder 463 and the second
flange 459 cooperate to create a recess 469 to receive and retain
the outwardly extending annular portion 436 of the neck 422 of the
first container 412. Additionally, the seal ring 439 has a series
of radially inwardly extending annular ribs 471 extending from the
sidewall 453 of the seal ring 439 to seal against the neck 422 of
the first container 412. As explained above, the seal ring 439 also
has an annular depression 437 in the top of the seal ring 439 to
receive the annular rib 467 extending from the top cap 464.
Finally, the seal ring 439 has a first opening 473 adjacent the
second flange 459, through which the vial 412 enters to engage the
seal ring 439, and a second opening to provide access to the
stopper 428 when the seal ring 439 is connected to the first
container 412. The seal ring 439 also has an inner flange 475
extending radially inward and opposing the first flange 455. The
inner flange 475 engages the legs 507 of the plug 489 as is
explained herein. In one embodiment the seal ring 439 is made of a
plastic material, and preferably a thermoplastic polyester
elastomer. Thermoplastic polyester elastomeric materials generally
provide the flexibility of rubbers, the strength of plastics and
the processibility of thermoplastics. They can be processed easily
by conventional thermoplastic processes like injection molding,
blow molding, calendaring, rotational molding, extrusion and
meltcasting.
[0042] Referring to FIGS. 4-9, an activation collar 438 is
connected to the outer sidewall of the body cap 416. The activation
collar 438 in combination with the body cap 416 assist in
controlling movement of the first container 412 as the first
container 412 is docked to the port assembly 418. The activation
collar 438 has a cylindrical sidewall 477 with a protrusion 479
extending inwardly from the inner surface of the sidewall 477, as
discussed above. The protrusion 479 is a mating member that mates
with the track 441 in the sidewall 442 of the body cap 416. In one
embodiment of the present invention, the activation collar 438 has
first and second protrusions 479 spaced 180.degree. apart.
Similarly, the body cap 416 has first and second tracks 441 spaced
180.degree. apart on the sidewall 442 of the body cap 416. It will
be appreciated the number and configuration of protrusions 479 and
tracks 441 can be varied without departing from the spirit and
scope of the present invention. The engagement between the
protrusions 479 on the activation collar 438 and the tracks 441 on
the body cap 416 maintain the activation collar 438 connected to
the outer sidewall of the body cap 416, and are explained in detail
herein. Additionally, the protrusion 479 on the activation collar
438 and the track 441 cooperate as a stop following docking of the
first container 412 in the port housing 482 of the second container
414 to preclude unintentional activation of the first container
412.
[0043] The activation collar 438 also has a plurality of splines
481 extending from the sidewall 477 thereof. In one embodiment the
splines 481 extend from an exterior surface of the sidewall 477 of
the activation collar 438. In one embodiment, the activation collar
438 has 36 splines 481. According, in that-embodiment the splines
481 are spaced every 10.degree.. However, it will be appreciated
that the number of splines 481 can be varied. The splines 481 of
the activation collar 438 engage a mating protrusions 519 on the
port assembly 418 (see FIG. 9) to preclude rotation of the
activation collar 438 when the first container 412 is attached or
"docked" to the second container 414. Such engagement is explained
in detail herein. In the configuration of the present invention
wherein 36 splines 481 are provided, the maximum angular rotation
required to have the splines 481 of the activation collar 438
engage the mating protrusions 519 of the port assembly 418 is
5.degree.. Additionally, in a preferred embodiment, the splines 481
on the outer surface of the activation collar 438 have a chamfered
lead-in to assist in mating the splines 438 with the mating
protrusions 519 as explained herein. The activation collar 438 also
has an activation marker 483 to provide a visual indication of
proper rotational alignment of the activation collar 438 with the
body cap 416 for activation. In a preferred embodiment the
activation collar 438 is made of a polypropylene material. As shown
in FIG. 10, the outer surface of the body cap 416, including the
activation collar 438, has a circumference that is smaller than the
opening to the port housing 482. In this manner, the body cap 416
secured to the first container 412 can be inserted into the port
housing 482 for docking and subsequent:activation of the first
container 412.
[0044] As shown in FIGS. 1, 4, and 9, the first container 412 has a
hanger cap 476 provided at the distal end of the body portion 420
of the first container 412. In one embodiment, the hanger cap 476
has a shape generally consistent with the shape of the distal end
of the body portion 420 of first container 412. In the depicted
embodiment, the hanger cap 476 has a generally cylindrical shape.
The hanger cap 476 also has a hingeable connector 478 extending
therefrom. As shown in FIG. 1, the connector 478 can be pivoted
from the lower portion of the hanger cap 476 to assist in hanging
the reconstitution system 410, such as from conventional IV pole or
other structure configured for holding an IV bag.
[0045] Referring now to FIGS. 1, 2, 4-7, and 9, in one embodiment
the first container 412 has a label 480 that connects the body cap
416 to the hanger cap 476, and secures the body cap 416 and the
hanger cap 476 on the first container 412. As shown in FIG. 9, in
such an embodiment when the body cap 416 and hanger cap 476 are
fully seated on the first container 412, a gap of approximately
0.060'' exists between mating ends of the body cap 416 and the
hanger cap 476.
[0046] The reconstitution system 410 also has an activation marker
487. In one embodiment the activation marker 487 is a colored band
487 on the label 480 joining the body cap 416 to the hanger cap
476. As explained herein, the activation marker 487 is visible when
the first container 412 is docked to the second container 414 (see
FIG. 5), as well as during the process of activation (see FIG. 6),
however, after full activation has occurred the activation marker
487 becomes hidden under the activation collar 438 (see FIGS. 1 and
7). Accordingly, a positive visual indication that full and
complete activation has occurred is provided when the activation
marker 487 is no longer visible.
[0047] Referring now to FIGS. 1-3, the second container 414 has a
port assembly 418 that is adapted to engage the body cap 416 of the
first container 412 to dock the first container 412 on the second
container 414. Accordingly, one function of the port assembly 418
is as a receiver for docking the drug vial 412. The port assembly
418 also includes a structure to facilitate fluid communication
between the first container 412 and the second container 414 for
activation, admixing, and/or reconstitution of the medicament in
the first container 412.
[0048] As shown in FIG. 3,the port assembly 418 generally comprises
a port housing 482, an actuator 484, a plug 489, a retainer 486, a
peelable cover 488 and an overcap 490. In the embodiment of the
present invention depicted in FIG. 3, the retainer 486 of the port
assembly 418 is a retainer or docking member 486. Portions of the
retainer 486 engage the first mating member (i.e., the first and
second flanges 450, 451) of the first container 412 during docking
and activation of the first container 412. The peelable cover 488
and overcap 490 assist in maintaining the sterility of the contents
of the port assembly 418. Peelable cover 488 and overcap 490 also
provide evidence of tampering with the contents of first container
412.
[0049] As best shown in FIGS. 3 and 9, the port housing 482 of the
port assembly 418 has a first housing portion 492 having a first
end 494 and a second end 496. A flange 498 extends radially
outwardly from the first end 494 of the first housing portion 492,
and a shoulder 499 extends radially inwardly from the second end
496 of the first housing portion 492. Another housing portion 502
extends from the first housing portion 492. In one embodiment as
shown in FIGS. 1 and 9, wherein the second container 414 is a
flexible diluent bag, the second container 414 is fixedly connected
to the outer wall of housing portion 502 of the port housing
assembly 418 to connect the port assembly 418 with the interior
cavity 415 of the second container 414. In such an embodiment
housing portion 502 preferably has a semi-elliptical outer shape
(as depicted in FIG. 3) to assist in sealing the second container
414 to the port housing 482.
[0050] The first housing portion 492 of the port housing 482 has an
interior surface 504 defining a first cavity 506, and housing
portion 502 has an interior wall 512 defining another cavity or
interior bore 514 of the port housing 482. The port housing 482 has
an annular recess 513 provided adjacent the exit to the bore 514 at
the distal end 515 of housing portion 502. In the embodiment
depicted in FIG. 9, a raised lip 517 is provided.
[0051] The plug 489 of the port assembly 418 is positioned in the
bore 514 of the port housing 482. The plug 489 has a seal member
491 positioned within or at the end of housing portion 502 to
prevent fluid from escaping into or out of the second container 414
through the inner bore 514 of port housing 482. The plug 489
fluidly separates the interior cavity 415 of the second container
414 from the interior bore 514 of the port housing 482.
[0052] The port housing 482 also has an interior seal wall 576
extending axially into the first cavity 506 of the First housing
portion 492 from the shoulder 499 at the second end portion 496 of
the first housing portion 492. In one embodiment the interior seal
wall 576 is generally cylindrically shaped, and is concentrically
positioned with respect to the interior surface 504 of the first
housing portion 492 of the port housing 482. In a second
embodiment, the interior seal wall 576 is slightly tapered. The
interior seal wall 576 extends downwardly and contacts or engages
the first flange 455 extending radially outwardly from the sidewall
453 at an upper first end 457 of the seal ring 439 during
activation of the first container 412. The engagement of the
interior seal wall 576 with the first flange 455 of the seal ring
439 during activation of the first container 412 operates as a
seal. As explained herein, when the first container 412 is
transitioned axially toward the second container 414 during the
activation step, the first flange 455 of the seal ring 439 will
slide on the interior seal wall 576, as shown in FIGS. 10-12. A
seal is created between the interior seal wall 576 and the first
flange 455 of the seal ring 439.
[0053] As explained above, the port assembly 418 has an actuator
484. In one embodiment, the actuator 484 is integral with the port
housing 482. As shown in FIGS. 3 and 9, the actuator 484 extends
axially into the first cavity 506 of the first housing portion 492
from the shoulder 499 at the second end 496 of the first housing
portion 492. The actuator 484 is further positioned radially
inwardly and generally concentrically to the interior seal wall 576
of the port housing 482. The actuator 484 is formed of a plurality
of ribs or sidewall members 501 that extend from the shoulder 499
of the port housing 482 and terminate at a bottom 503. In a
preferred embodiment, the actuator 484 is comprised of three
sidewall members or ribs 501 with axial gaps 505 between each
sidewall member or rib 501. The sidewall members or ribs 501 define
a central cavity 521 of the actuator 484, and the axial gaps 505
provide access to the central cavity 521. The central cavity 521
ultimately becomes a fluid flow path. The outside diameter of the
sidewall members or ribs 501 approximates the inside diameter of
the opening 424 of the first container 412. The distal end of the
sidewall members or ribs 501 can be tapered inwardly toward
actuator bottom 503. As is explained herein, the actuator 484 is
preferably constructed of a relatively rigid material, e.g., a
rigid plastic, so that it can be used to displace the stopper 428
into the internal cavity 426 of the first container 412 as shown in
FIGS. 11-12. The large axial gaps 505 of the actuator 484
facilitate fluid communication with the contents of the first
container 412 when the actuator 484 is positioned within the
opening 424 of the first container 412. In a preferred embodiment
the port housing 482 and its integral actuator 484 are made of a
polypropylene copolymer.
[0054] As explained above, the plug 489 of the port assembly 418 is
positioned within the bore 514 defined by the interior wall 512 of
housing portion 502. The plug 489 has an end wall 497 with an
annular seal member 491 at the distal end 493 thereof. The seal
member 491 surrounds the circumference of the distal end 493 of the
plug 489. An annular rib 495 of the seal member 491 engages the
annular recess 513 in the port housing 482 to seal the interior
cavity 415 of the second container 414 from the interior bore 514
of the port housing 482. The plug 489 also has a plurality of legs
507 extending axially away from a main body 509 of the plug 489. In
a preferred embodiment, the plug 489 has three legs 507 as shown in
FIGS. 3 and 9. A radial extension 511 is provided at the terminal
end of each leg 507. As is explained herein, the radial extensions
511 of the legs 507 are provided to engage the seal ring 439.
Finally, a cavity 513 is defined between the legs 507 of the plug
489. The cavity 513 is fully accessible through the gaps between
the legs 507 of the plug 489 and at the distal open end of the plug
489.
[0055] As best shown in FIGS. 3 and 9, the retainer or docking
member 486 is located within the first cavity 506 of the first
housing portion 492 of the port housing 482. The retainer 486
comprises a body portion having a base 518, a plurality of
different length tabs 520, 522 extending from the base 518, and a
flange 524 extending from a proximal end of the retainer 486. The
retainer 486 also has one or more protrusions 519 extending from an
interior surface of the base 518. The protrusions 519 mate with the
space between the splines 481 on the outer surface of the
activation collar 438. In one embodiment, the protrusions 519 in
combination with the geometry of the base 518 also operate as a
stop for the activation collar 438 when the first container 412 is
inserted into the port assembly 418 (shown in FIG. 10) for docking
of the first container 412 therein. In one embodiment the flange
524 of the retainer 486 is fixed to the flange 498 of the port
housing 482, e.g., the upper surface of the flange 524 of the
retainer 486 is ultrasonically welded to the lower surface of the
flange 498 of the port housing 482. Accordingly, in such an
embodiment the retainer 486 is fixed in the port housing 482.
Retainer 486 and port housing 482 can be formed from a single piece
of material or from multiple components without departing from the
scope of the present invention.
[0056] As shown in FIGS. 3 and 9-12, and explained above, the
retainer 486 has a plurality of tabs 520, 522. In one embodiment, a
first set of tabs 520 are shorter in height than a second set of
tabs 522. In this embodiment, the first set of tabs 520 is utilized
to support the first container 412 in the docked position as shown
in FIG. 10, and the second set of tabs 522 is utilized to support
the first container 412 in the activated position as shown in FIG.
12. Each of the tabs 520 and 522 can include a tapered portion at
the distal end thereof. Retainer 486 can be constructed of a
flexible material, such as plastic, e.g., a polypropylene
copolymer, to allow the tabs 520, 522 to be flexed when the first
container 412 is inserted into the port housing 482, and thereafter
allowing tabs 520, 522 to spring back into their original position.
Accordingly, tabs 520 and 522 allow the first container 412 to be
pushed in a first axial direction toward the second container 414,
but resist movement backward in the opposing direction to prevent
the first container 412 from being removed from engagement with the
port housing 482 following docking and activation of the first
container 412.
[0057] Referring to FIGS. 9-12, as the first container 412 is
inserted into the port housing 482, the first annular flange 450
centers the first container 412 in the opening at the proximal end
the retainer 486 of the port housing 482. As the first container
412 is pushed axially inward, the first annular flange 450 flexes
the distal end of the first set of tabs 520 radially outwardly to
allow the first annular flange 450 to extend axially inwardly of
the tabs 520. When the first annular flange 450 is positioned
inwardly of the first set of tabs 520, the tabs 520 will flex back
and return to their original, unflexed positions. In this position,
as shown in FIG. 10, the annular flange 450 is docked on the first
set of tabs 520, and the first set of tabs 520 prevent the annular
flange 450, and thus the first container 412, from being pulled out
of the retainer 486. In this-way the system prevents first
container 412 from being "undocked" from second container 414 after
the docking process has been completed, thereby minimizing the
possibility of tampering and/or the compromising of the sterility
of the system. Further, in this position the splines 481 on the
activation collar 438 engage the protrusions 519 on the retainer
486 to prevent the activation collar 438, and moreover, the entire
first container 412, from rotating within the port housing 482.
[0058] After the first container 412 is docked in the port housing
482, the system 410 can be activated at any subsequent time. To
activate, the first container 412 is initially moved axially
inwardly toward the port housing 282, such that the protrusion 479
on the activation collar 438 overcomes the defeatable stop 449 (see
FIG. 5). Next, the first container 412 is rotated with respect to
the fixed activation collar 438, by rotating the first container
412 (see FIG. 6). As explained above, movement of the first
container 412 is limited to that allowed by the track 441. After
the first container 412 is rotated such that it has exhausted the
possible translation of the protrusion 479 in the horizontal
portion 445 of the track 441, the first container 412 can again be
axially translated toward the second container 414 and further
within the port housing 482 (see FIG. 7).
[0059] While the activation step has been identified functionally
above, it will herein be described structurally. As the first
container 412 is pushed axially inwardly on the second vertical
track portion 447 and into the first cavity 506 of the port housing
482, the first annular flange 450 will contact the distal end of
the second set of tabs 522 and flex the second set of tabs 522
radially outwardly to allow the first annular flange 450 to extend
axially inwardly of the second set of tabs 522 (see FIG. 11). This
is referred to as the partially activated position. To obtain full
activation, as shown in FIG. 12, the first container 412 must be
pushed even further axially inwardly on the second vertical track
portion 447 and into the first cavity 506 of the port housing 482.
As shown in FIG. 12, the second annular flange 451 will contact the
distal end of the second set of tabs 522 and flex the second set of
tabs 522 radially outwardly to allow the second annular flange 451
to be positioned axially inwardly of the second set of tabs 522.
When the second annular flange 451 is positioned inwardly of the
second set of tabs 522, the tabs 522 will flex back and return to
an unflexed position (see FIG. 12). This is referred to as the
activated or fully-activated position. In this position, the second
annular flange 451 is positioned on the second set of tabs 522, and
the second set of tabs 522 prevents the second annular flange 451,
and thus the first container 412, from being pulled out of the
retainer 482. In this position the first container 412 is prevented
from further axial movement toward the second container 414. These
features prevent intentional tampering as well as other activities
that could compromise the sterility of the contents of first
container 412 and second container 414.
[0060] In the embodiment of the present invention shown in FIG. 3,
the port assembly 418 also includes a peelable cover 488. The
peelable cover 488 is positioned on the flange 424 of the retainer
486 connected to the port housing 482 to provide a protective seal
over the opening to the port assembly 418 and to seal the interior
of the port assembly 418, including all components and surfaces
thereof, from the outside environment and to provide sterility to
this area. In one embodiment the peelable cover 488 is made of
Tyvek.RTM. material (or other known materials) and an appropriate
adhesive on one side thereof to facilitate the bonding of peelable
cover 488 to retainer 486. Peelable cover 488 can have one or more
tabs or extensions to assist in its removal from retainer 486. An
overcap 490, preferably made of a plastic material, is preferably
constructed to serve as a protector for the peelable cover 488. In
the embodiment depicted in the attached figures, the overcap 490
has a pair of sidewalls and flanges that grasp around the peelable
cover 488 and onto the flange 498 of the port housing 482 to retain
the over cap 490 on the port assembly 418.
[0061] In one embodiment of the present invention, in order to mix
or reconstitute the contents of the first container 412 with the
contents of the second container 414, the first container 412 is
docked or connected to the port assembly 418 of the second
container 414 as shown in FIG. 1. As explained herein, following
the docking step, the cavities of each container 412, 414 are
placed in fluid contact through an activation process, whereby the
contents of the first and second containers 412, 414 can be
combined or admixed.
[0062] Referring to FIG. 2, the first container 412 can be
maintained separate from the second container 414 until the drug is
requested by a doctor. After a prescription is ordered, a
pharmacist or clinician will remove the top cap 464 from the body
cap 416 of the first container 412. The pharmacist or clinician
also will remove the over cap 490 and peelable cover 488 from the
port housing assembly 418. The first container or drug vial 412 is
now available to be "docked" onto the port assembly 418, typically
in the pharmacy, by pushing the drug vial 412 into the port
assembly 418, as shown in FIGS. 10-12. When the first container 412
is moved axially into the port assembly 418., the first annular
flange 450 contacts the first set of short tabs 520 and flexes the
short tabs 520 radially outwardly to allow the first flange 550 to
move past the tabs 520. After the flange 450 passes the end of the
tabs 520, the tabs 520 will spring back to their original, unflexed
positions, thereby locking first container 412 in the docked
position relative to second container 414. As the flange 450 is
forced past the first set of tabs 520 the pharmacist will typically
hear an audible "pop," signaling that the flange 450 has passed
over the tabs 520 and that the vial 412 is docked and locked in the
ready position. Further, in this position, the tabs 520 preclude
reverse axial movement and thus do not allow the first container
412 to be removed from the port housing 482. In addition to
preventing possible tampering, the locking of first container 412
in the docked position ensures that first container 412 is not
inadvertently disconnected from second container 414 prior to
activation. Such disconnection could occur during transport of the
first container 412 and second container 414 (by known means such
has by hand, by medicine cart, or by pneumatic system) or during
storage of the docked system.
[0063] Additionally, during docking the first flange 455 that
extends radially outward from the sidewall 453 of the seal ring 439
engages the tapered interior seal wall 576. Due to the engagement
of the flange 455 on the tapered interior seal wall 576, a seal is
created between the interior seal wall 576 and the first flange 455
of the seal ring 439. As shown in FIG. 10, during docking, the
bottom 503 of the actuator 484 engages the top surface 432 of the
stopper 428 and exerts a minor force on the stopper 428.
[0064] In the docked state, as shown in FIG. 10, the contents of
the first container or drug vial 412 remain separate from the
contents of the second container or diluent bag 414, however, the
first container 412 is fixed to the port assembly 418 and second
container 414, and cannot be removed therefrom without generally
destroying various of its components. Thus, at this point the drug
vial 412 is mechanically connected to the port assembly 418, but is
not fluidly connected to the diluent bag 414. It is understood that
in the docked state the contents of the two containers 412, 414
remain completely separated, and thus the two containers 412, 414
can remain in the docked state without admixing for an extended
period typically limited only by the shelf life of the contents in
the two containers 412, 414. In the docked state the stopper is
positioned in the opening of the vial, thereby providing a moisture
and air barrier for the contents of the first container 412. At any
time after the drug vial 412 is "docked" on the port assembly 418,
a nurse or other clinician can activate the system, thereby
enabling mixing or reconstitution of the drug in the first
container 412 with the diluent in the second container 414.
[0065] To activate the two-part admixing system 410 the clinician
will push the first container 412 axially toward the second
container 414. In this step the clinician will have to overcome the
defeatable stop 449 by pushing the stop 449 past the protrusion 479
on the inner surface of the activation collar 438 (see FIG. 5).
Next, as shown in FIG. 6, the clinician will have to rotate the
first container 412 with respect to the fixed activation collar 438
and port housing 482. Again, to preclude unintentional activation,
in one embodiment the clinician will have to exert enough of a
force to push the stop 449 in the horizontal track portion 445 past
the protrusion 479 on the activation collar 438. Finally, as shown
in FIGS. 7 and 11-12, the clinician will further push the first
container 412 axially toward the second container 414 and into the
fully activated position on the second set of tabs 522.
[0066] In the final axial activation stage, the seal between the
seal member 491 of the plug 489 and the port housing 482 is broken
as the plug 489 is forced partially into the cavity of the second
container 414. Additionally, the stopper 428 is forced down the
opening 424 in the vial 412 and into the inner cavity 426 of the
vial 412 as is shown in FIGS. 11 and 12 by the proximal end 503 of
the actuator 484, thereby creating a fluid flow path between the
first container 412 and the second container 414.
[0067] The opening of the fluid flow path to the second container
414 is depicted in FIG. 11. When the first container 412 is pushed
axially toward the second container 414 during activation, the legs
507 push past the inner flange 475 of the seal ring 439 and engage
the outwardly extending annular portion 436 of the first container
412. Further, the inner flange 475 captures the legs 507 between
the inner flange 475 and the lip 436 of the vial 412, maintaining
the legs 507 therebetween. Accordingly, as the first container 412
is pushed further axially toward the second container 414 the force
will disengage the annular rib 495 of the seal member 491 on the
plug 489 from the annular recess 513 in the port housing 482, and
force the plug 489 into the cavity of the second container 414,
thereby opening the fluid flow path to the second container 414. As
shown in FIG. 11, and as explained above, the first flange 455
engages the interior seal wall 576 during activation of the first
container 412. The engagement of the interior seal wall 576 with
the first flange 455 of the seal ring 439 operates to seal the
contents of the second container 414 from escaping out of the port
housing 482 and past the first container 412.
[0068] As shown in the transition from FIG. 11 to FIG. 12, further
axial movement of the first container 412 toward the second
container 414 operates to transition the stopper 428 into the
cavity 426 of the first container 412, thereby creating a fluid
flow between the first container 412 and the central cavity 521 of
the actuator 484. In one embodiment, the stopper 428 will
ultimately be translated entirely through the opening 424 in the
first container 412 and will be deposited within the cavity 426 of
the first container 412. At this point the cavity 426 of the first
container 412 is open to the central cavity 521 of the actuator
484. As shown in FIG. 12, the central cavity 521 of the actuator
484 has nearly as large a cross section as the opening 424 to the
first container 412. This assists the reconstitution system 410 by
not restricting the flow of fluid into and out of the first
container 412.
[0069] As the first container 412 is moved to the fully activated
position, the second annular flange 451 of the body cap 416 moves
axially up the retainer 486 toward the second container 41.4 and
past the second set of tabs 522. In this position, as shown in FIG.
12, the second annular flange 451 is positioned on the second set
of tabs 522, and the second set of tabs 522 prevents the second
annular flange 451, and thus the first container 412, from reverse
or proximal axial movement (i.e., they prevent the first container
412 from being pulled out of or detached from the port housing
482). This is referred to as the activated position.
[0070] An additional aspect of one embodiment of the two-part
admixing system 410 is that a visual indication of activation of
the system 410 is provided. As shown in FIGS. 1, 2 and 5-7, in one
embodiment an activation marker 487 is provided. The activation
marker 487 may be a colored or printed band 487 on the label 480
joining the body cap 416 to the hanger cap 476. When the first
container 412 is in the docked position the activation marker 487
is visible. This indicates to the clinician that the system 410 has
not yet been activated. The activation marker 487 is visible when
the first container 412 is docked to the second container 414 (see
FIG. 5), as well as during the process of activation (see FIG. 6).
After full activation has occurred, the activation marker 487
becomes hidden under the activation collar 438 (see FIGS. 1 and 7).
The inability to see the activation marker 487 indicates to the
clinician that the admixing system 410 has been activated and that
fluid flow between the contents of the two containers 412, 414 is
open. The inability of the clinician to see the activation marker
487 also indicates to the clinician that the contents of containers
412. 414 are ready for delivery to a patient, i.e., that the
contents of containers 412, 414 have been admixed or diluted for
delivery to the patient.
[0071] An additional aspect of one embodiment of the two-part
admixing system 410, shown in FIG. 13, is that after the top cap
464 is removed from the body cap 416, the contents of the first
container 412 can be accessed with a syringe to either remove some
of the contents thereof, add a small amount of diluent to the
contents thereof, or a combination of adding contents and removing
mixed contents from the first container 412. To perform such
operations, the clinician may pierce the stopper 428 with the
needle of a syringe to access the cavity of the first container 412
as shown in FIG. 13. In this embodiment, first container 412 can be
used as a standard pharmaceutical vial, i.e., a vial that is
accessed using a hypodermic needle associated with a syringe, and
as a component of the two-part admixing system 410 of the present
invention. Stopper 428 is preferably constructed of a polymeric
material that is resistant to coring when a hypodermic syringe
needle is pushed therethrough. The configuration and material of
stopper 428 are preferably selected such that the force required to
push a hypodermic syringe needle there through is ergonomically
acceptable to clinicians. In one embodiment of the present
invention, the force required to pierce stopper 428 with a
hypodermic syringe needle is less than 1.5 pounds of force. In an
alternative embodiment, the force required to force a hypodermic
syringe needle through stopper 428 is in the range of 0.5-1.0
pounds of force. The configuration and material of stopper 428 also
are preferably selected such that the force required to push
stopper 428 into the interior of first container 412 upon
activation of the system of the present invention is appropriate in
view of the mechanical strength of the system and ergonomics. It
will be appreciated that the force required to push stopper 428
into the interior of first container 412 should be great enough to
prevent inadvertent activation while simultaneously being small
enough to permit both (i) the system of the present invention to be
constructed of relatively low-cost materials; and (ii) a clinician
to readily move the system into its activated state. In one
embodiment of the present invention, the force required to push
stopper 428 into the interior of first container 412 is in the
range of 4-20 pounds of force. In a second embodiment, the force
required to push stopper 428 into the interior of first container
412 is in the range of 5-15 pounds of force. In a third embodiment,
the force required to push stopper 428 into the interior of first
container 412 is in the range of 8-13 pounds of force. The material
used to construct stopper 428 is preferably a material that is
inert to the intended contents of first container 412. Where first
container 412 is intended to contain a pharmaceutical product, the
material of construction of stopper 428 is ideally a material that
is already approved by regulatory agencies for use With the
pharmaceutical product, thereby minimizing or eliminating the need
to undertake extensive compatibility testing to ensure that there
is no undesirable interaction between the pharmaceutical product
and the stopper 428.
[0072] In one embodiment, second container 414 is constructed of a
non-PVC, DEHP-free material providing a vapor barrier capability
that is sufficient so as to permit diluent or drug product to be
stored therein without the use of an overwrap. For example, second
container 414 can be constructed of the materials utilized by
Hospira, Inc., in the manufacture of its VISIV.RTM. flex
container.
[0073] Several alternative embodiments and examples have been
described and illustrated herein. A person of ordinary skill in the
art will further appreciate that any of the embodiments could be
provided in any combination with the other embodiments disclosed
herein. Additionally, the terms "first," "second," "third," and
"fourth" as used herein are intended for illustrative purposes only
and do not limit the embodiments in any way. Further, the term
"plurality" as used herein indicates any number greater than one,
either disjunctively or conjunctively, as necessary, up to an
infinite number. Additionally, the term "having" as used herein in
both the disclosure and claims, is utilized in an open-ended
manner.
[0074] It will be understood that the invention may be embodied in
other specific forms without departing from the spirit or central
characteristics thereof. The present examples and embodiments,
therefore, are to be considered in all respects as illustrative and
not restrictive, and the invention is not to be limited to the
details given herein. Accordingly, while the specific embodiments
have been illustrated and described, numerous modifications come to
mind without significantly departing from the spirit of the
invention and the scope of protection is only limited by the scope
of the accompanying claims.
* * * * *