Closure and port assembly

A port and closure assembly is provided. The port and closure assembly comprises a port including a tubular portion that extends from a base, the tubular portion terminating at an end including an opening. A closure is provided for sealing at least a portion of the end of the port, the port and closure being constructed from materials that create a tack seal when the closure is positioned on the port and the port and closure are sterilized, the tack seal functioning to secure the closure to the port.

BACKGROUND OF THE INVENTION 
The present invention relates generally to a pprt and closure assembly. 
Ports are utilized to provide a method for accessing material packaged 
within a container. As used herein, the term "ports" includes, without 
limitation, fitments, valves, and other means for accessing a container. 
In the medical industry, parenteral and peritoneal dialysis solutions, for 
example, are packaged in flexible containers that are accessed via a port. 
An example of such a flexible container is the VIAFLEX collapsible plastic 
container sold by Baxter Healthcare Corporation of Deerfield, Ill. 
In the medical industry particularly, and other applications, it is 
essential that the solution in the container is maintained and extracted 
under sterile conditions. This requires not only that the container and 
its contents remain in a sterile sealed condition at the time of receipt 
by the user, but also that no contamination of the contents occur when the 
container is opened by the user. 
Typically, the port comprises a tubular structure with an inner bore that 
extends from a base. Located within the inner bore is a pierceable wall 
that provides a barrier between the fluid contained within the container 
and the outside environment. Usually, pointed means that pierce the 
pierceable wall are used to gain access to the fluid and thereby the 
container. To protect against contamination at the port exit, closures are 
utilized to cover the tubular bore of the port. 
Some of the prior art closures have not been entirely satisfactory. Some of 
the problems experienced by the prior closures are the fact that they do 
not provide a hermetic seal, are difficult to remove, and do not lend 
themselves to high speed production. Furthermore, there is also the 
problem that the closure must be adequately secured to the port so that it 
does not fall off during transportation or prior to the time one desires 
to access the container. 
Furthermore, some of the closures of the prior art have not been entirely 
satisfactory because they do not provide a tamper evident closure. Because 
it is critical that a sterile environment is maintained, it is 
advantageous that the closure and port cooperate to provide some means for 
alerting the user that the closure has been opened and accordingly, the 
aseptic environment violated. 
A further problem with some prior art closures, is the fact that they 
typically cannot be used to identify the solution contained within the 
container once the closure is opened. To identify the type of solution 
contained in a container, closures may be color coded. But, once the 
closure is removed from the port, the container is no longer coded. 
Thus, there is a need for a port and closure assembly that overcomes some 
of the disadvantages of the prior art. 
SUMMARY OF THE INVENTION 
The present invention provides an improved port and closure assembly. To 
this end, a port and closure assembly is provided comprising a port 
including a tubular portion that extends from a base, the tubular portion 
terminating at an end including an opening. A closure, for sealing at 
least a portion of the end of the port, is provided for sealing the 
opening of the port. The port and closure are constructed from materials 
that create a tack seal when the closure is positioned on the port and the 
port and closure are sterilized. The tack seal functions to secure the 
closure to the port. 
In an embodiment of the present invention the closure is constructed from 
EPDM rubber. 
In an embodiment of the present invention, the port is constructed from a 
polypropylene. In a preferred embodiment of the present invention, the 
port is constructed from a rubber modified polypropylene, such as a Kraton 
modified polypropylene. 
In an embodiment of the present invention, the port and closure are steam 
sterilized. 
In an embodiment of the present invention, the port and closure are 
presterilized by gamma sterilization. 
In an embodiment of the present invention, a tamper evident closure for 
removably sealing an opening of a port is provided. The closure includes a 
first end for gripping the closure. A second end is provided that defines 
a sleeve portion for circumscribing a portion of the port when the closure 
is positioned so that it seals an opening of the port. An intermediate 
segment extending between the first end and the second end is provided. 
The intermediate segment has a portion that has a reduced cross-sectional 
thickness with respect to other portions of the intermediate portion. The 
portion has a sufficiently reduced cross-sectional thickness allowing a 
portion of the closure located on a first end of the portion having a 
reduced thickness to separate from remaining portions of the closure 
located on a second end of the portion having a reduced thickness when the 
sleeve is secured to the port. A pulling force is typically exerted on the 
first end to separate the portions. Preferably, the closure and port are 
constructed from materials that provide a tack seal when the port and 
closure are sterilized. 
In an embodiment of the present invention, the portion having the reduced 
thickness is located at a point in juxtaposition to a top edge of the 
sleeve. 
An advantage of the present invention is that it provides an improved port 
and closure assembly. 
A further advantage of the present invention is that it provides a tamper 
evident closure for a port. 
Still an advantage of the present invention is that it provides a port and 
closure assembly wherein the port and closure cooperate to create a tack 
seal when they are sterilized to insure that the closure is secured to the 
port. 
Moreover, a further advantage of the present invention is that it provides 
a closure that can be easily removed from an opening of the port allowing 
the port to be accessed. 
A still further advantage of the present invention is that it provides a 
closure that will leave a band on the port after the closure is removed. 
Additional features and advantages of the present invention are described 
in, and will be apparent from, the detailed description of the presently 
preferred embodiments and from the drawings.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS 
The present invention provides an improved port and closure assembly. 
Referring to FIG. 1, an embodiment of the closure 10 and port 12 is 
illustrated. The closure 10 is designed to seal the port 12 and provide 
means for accessing a container 14. The container 14 can be any container 
known in the art. However, the invention is directed to use with a 
flexible container made out of plastic or like material. The invention is 
particularly directed, although not exclusively, to use in medical 
applications wherein the container contains a fluid that must be 
maintained and extracted under sterile conditions. Accordingly, it is 
critical that sterility be maintained at the port 12. 
The port 12 includes an outer wall 16 that defines a tubular bore 18. A 
partition wall 19 divides the tubular bore into an upper bore and a lower 
bore. The port 12 is typically inverted when the container is hung to 
dispense fluid, and the partition wall 19 functions to prevent the fluid 
from long term contact with the closure. Furthermore, the partition wall 
19 prevents fluid flow until the container 14 is accessed by a spike. 
Preferably, the opening 22 has a construction that allows it to sealingly 
receive the spike when the spike accesses the container 14 and pierces the 
partition wall 19. 
The upper bore, when the closure 10 does not seal the port 12, is in fluid 
communication with the outside environment through an opening 22. The 
opening 22 allows the upper bore to receive a spike or other access means 
that can pierce the partition wall and thereby access the port 12 and 
container 14. 
The closure 10 functions to seal the port 12, and specifically the inside 
and outside of opening 22. It is especially important in medical 
applications that this is a hermetic seal so that when the fluid within 
the container is accessed for intravenous use, the fluid is not 
contaminated with bacteria or other contaminants. 
Referring now to FIG. 2, the closure 10 is specifically illustrated. The 
closure 10 includes a gripping member 32 that provides a surface that can 
be grasped by the user when placing the closure 10 on the port 12 during 
assembly or removing same therefrom by the user. Extending from a portion 
of the gripping member 32, in the preferred embodiment illustrated, is a 
stem member 34. The stem member 34 has a sufficiently reduced 
circumference to allow it to be received within the tubular bore 18 of the 
port 12. 
Extending from the end of the gripping member 32 is an intermediate segment 
35. As discussed in more detail below, the intermediate segment 35 
cooperates to define means for allowing a first portion 37, defined in 
part by the gripping member 32, to be separated from a second portion 39, 
defined by remaining portions of the closure 12. 
Connected to a second end of the intermediate section 35 is a sleeve member 
36. The sleeve member 36 is so constructed and arranged that it 
circumscribes a portion 15 of the port 12, as illustrated in FIG. 2, when 
the closure 10 is secured to the port 12. The sleeve member 36 defines, 
with the stem member 34, an interface 38 that is so constructed and 
arranged that it will receive the top portion 15 of the port 12 therein. 
As illustrated in FIG. 2, the intermediate segment 35 includes a portion 40 
having a reduced cross-sectional thickness. This portion 40 having a 
reduced crosss-ectional thickness is designed to rupture, or separate, 
allowing a first portion 37, defined by the gripping member 32 and a 
portion of the intermediate segment 35, to separate from the remaining 
portions 39 of the closure 10, principally, the sleeve member 36. This 
allows, when the sleeve member 36 is secured to the port 12, a first 
portion 37 of the closure 10 to be removed from the port 12, and remaining 
portions 39 of the closure 10, allowing the opening 22 of the port 12 to 
be accessed. 
The closure 10, and specifically the sleeve member 36, and port 12 are so 
constructed and arranged that they provide a tack seal between the closure 
10 and the port 12, at the interface 38, when the closure is seoured on 
the port. Specifically, the port 12 and closure 10 are constructed from 
materials that create a tack seal that is created when the port 12 and 
closure 10 are sterilized. This tack seal is strengthened by either steam 
sterilization or gamma sterilization. 
Because the container 14, and port 12 and closure 10, must be sterilized 
before they are used, the present invention provides a port and closure 
assembly that reduces the manufacturing steps and costs during the 
manufacturing of the port and closure assembly. To this end, the closure 
10 is merely stretched over the port 12 and during the sterilization 
process of the port 12 and closure 10 and container 14, the closure is 
sealed to the port. 
Preferably, the port 12 is constructed from a polypropylene blend. 
Preferably, the port 12 is constructed from a thermoplastic elastomer 
modified polypropylene. In a preferred embodiment, the port 12 is 
constructed from a Kraton modified polypropylene. 
Preferably, the closure 10 is constructed from EPDM rubber. An EPDM rubber 
purchased from West Company as No. 1711 Blue has been found to function 
satisfactorily. 
In use, when it is desired to access the container 14, the user grasps the 
closure 10 by the gripping member 32. The user then exerts a pulling force 
on the gripping member 32. This causes the intermediate segment 35, and 
specifically the portion 40 of the segment having a reduced 
cross-sectional thickness to rupture. The closure 10 is then separated 
into a first 37 and second portion 39 exposing the opening 22 of the port 
14. 
A tamper evident closure is provided in that after the closure 10 has been 
separated into a first portion 37 and second portion 39, the sleeve 36 
still circumscribes the port 12. If desired, the sleeve 36 can be color 
coded to identify the contents of the container. 
Referring now to FIGS. 4 and 5, another embodiment of the port 112 and 
closure 110 assembly of the present invention is illustrated. Again, the 
port 112 includes an outer wall 116 that defines a tubular bore 118. The 
closure 110 functions to seal the port 112 and specifically, an opening 
122 defined by the port 112. 
The closure 110 includes a gripping member 132 that provides a surface that 
can be grasped by the user when placed in the closure 110 and the port 112 
during assembly or removing same therefrom by the user. 
Extending from an end of the gripping member 132 is an intermediate segment 
135. The intermediate segment 135 cooperates to define means for allowing 
a first portion 137, defined, in part, by the gripping member 132 to be 
separated from a second portion 139 defined by remaining portions of the 
closure 110. 
In this regard, again, connected to a second end of the intermediate 
segment 135 is a sleeve member 136. The sleeve member 136 is so 
constructed and arranged that it circumscribes a portion of the port 112 
as illustrated in FIG. 4. As in the previous embodiment, a first portion 
of the closure is designed to separate from a second portion a closure 
when a sufficient pulling force is exerted on the gripping member. The 
closure 110 is designed to separate at point 141. The closure 110 is 
constructed from a material that creates a tack seal with the port 112, as 
in the previous embodiment. 
Referring now to FIGS. 6 and 7, another embodiment of the closure assembly 
of the present invention is illustrated. The closure assembly 210 can be 
used with a port such as those illustrated in FIGS. 1-4. Again, the 
closure 210 is constructed from a material that creates a tack seal with 
the port as in the previous embodiments. 
In this embodiment, the closure 210 includes a gripping member 232, a 
sleeve member 236 and an intermediate section 235. Located between 
intermediate section 235 and sleeve member 236 is a point 240 of reduced 
thickness along which the closure 210 will rupture when a sufficient 
pulling force is exerted against the gripping member 232. 
It should be understood that various changes and modifications to the 
presently preferred embodiments described herein will be apparent to those 
skilled in the art. Such changes and modifications can be made without 
departing from the spirit and scope of the present invention and without 
diminishing its attendant advantages. It is therefore intended that such 
changes and modifications be covered by the appended claims.