EP0203099B1

EP0203099B1 - Port and elastic closure

Info

Publication number: EP0203099B1
Application number: EP85905380A
Authority: EP
Inventors: Thomas A. Fowles
Original assignee: Baxter International Inc
Current assignee: Baxter International Inc
Priority date: 1984-11-13
Filing date: 1985-10-29
Publication date: 1989-06-14
Also published as: JPH0554790B2; DE3571017D1; ZA858569B; WO1986002907A1; EP0203099A1; CA1292442C; EP0203099A4; JPS62500704A

Abstract

A port (12) and closure (10) assembly. The closure (10) includes a sleeve member (32) and the port a rib member (34). The sleeve member (32) having an inner circumference that is less than the outer circumference of the rib (34). The port (12) and closure (10) cooperating to produce an audible signal when the closure (10) is removed from the port (12).

Description

This invention relates to a port and closure assembly. In particular, the present invention relates to a port and elastic closure for a medical solution container.
Typically, elongated ports are utilized to access solutions contained in flexible containers. As used herein, the term ports includes, without limitation, fitments, valves, and other means for accessing a container. The ports function as injection sites or means for accessing the solution in the flexible container. To this end, the ports contain an open end that can receive a needle or other piercing means. In the medical field, these flexible containers may contain parenteral solutions, peritoneal solutions, and the like. An example of such a container is the Viaflex @ collapsible plastic container for parenteral solutions sold by Travenol Laboratories, Inc. of Deer- field, Illinois.
Fluids intended for intrabody administration must be sterile at the time of use to avoid the danger of introducing harmful agents into the body. Accordingly, the container must be able to house the solution so that the solution is maintained and extracted under sterile conditions. This requires not only that the container and its contents be 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 a physician, nurse, or medical technician prior to use. The problem of maintianing sterility is particularly acute at the port of the container where the fluid is accessed.
To guard against contamination a protective port closure is utilized with the port. One problem with the prior port closures is that they do not consistently provide an aseptic closure. Accordingly, user confidence with port and closure assemblies is not great.
Thus, there is a need for an improved closure that overcomes the problems of the prior art. This invention provides a port and closure assembly for use on flexible containers designed to contain pharmaceutical and other medicinal solutions. The closure is designed to hermetically seal the port and cooperates with the port to produce an audible signal when the closure is removed from the port. To this end, the sleeve of the closure is designed to cooperate with a rib circumscribing the port to produce a snap when the closure is removed from the port.
Accordingly, it is an essential aspect of the present invention to provide an elastic closure that produces an audible signal when it is removed from the tubular port and the partition wall of the tubular port is intact.
Another advantage of the present invention is that it provides an elastic closure that aseptically seals the port.
A further advantage of the present invention is that it provides an elastic closure that may be removed by the user with one hand.
An additional object of the present invention is to provide an elastic closure that lends itself to mechanical assembly.
A still further advantage of the present invention is that the closure includes ribs that aid in the molding process of the closure.
US-A-3994412 discloses a port and closure assembly for a solution container comprising a tubular port for providing access to fluid within the container, the port having an elongate bore, an outer wall defining the bore and a piercable wall closing the bore, and an elastic closure sealing the port and comprising an elongate top member, a guide member receivable in the bore and a sleeve member surrounding the guide member and engagable around the outer wall of the port.
The present invention is characterised in that the piercable wall is located within the bore, the sleeve member has, in an unstressed condition, an inner circumference less than the outer circumference of the portion of the outer wall with which the sleeve engages, the outer wall has an outwardly projecting rib with which the sleeve engages and the construction is such that an audible snap is produced as the sleeve is released from the rib during removal of the closure, but only if the piercable wall has not been pierced.
US-A-4046276 and FR-A-2245538 provide similar disclosures to US-A-3994412.
US-A-3554256 discloses a port having an overmolded closure wherein the closure extends over a rib on the outer wall of the port.
Features and advantages are described in, and will be apparent from, the detailed description of a preferred embodiment of the invention and from the drawings in which

Figure 1 illustrates a cross-sectional view of a preferred embodiment of the port and elastic closure of the present invention,
Figure 2 illustrates a cross-sectional view of another preferred embodiment of the port and elastic closure of the present invention.

Figure 1 illustrates the closure 10 and port 12 of the present invention. The port 12 extends from a solution container 14 and functions to provide a means of accessing the solution container. The solution container 14 includes an opening 16 which is in fluid communication with a lower tubular bore 18 in the port 12. The port 12 includes a partition wall 20 that divides the lower tubular bore 18 from an upper tubular bore 21. In order to access the container 14, and thereby the solution contained therein, the partition wall 20 must be broken or pierced. Typically, a needle or other sharp instrument is utilized to pierce the partition wall 20 and thereby access the fluid contained within the solution container 14.
The closure 10 functions to seal the opening 22 in the port 12. This is necessary to ensure that an aseptic environment is present within the upper tubular bore 21. If the upper tubular bore 21 is not maintained as an aseptic environment, when the partition wall 20 is pierced the fluid will be contaminated thereby introducing harmful agents into the patient's body.
The closure 10 includes a guide member 24 that is designed to be received within the upper tubular bore 21. The guide member 24 has an outer circumference that is less than the inner circumference of the upper tubular bore 21. Accordingly, when the guide member 24 is received within the upper tubular bore 21 a friction fit is not necessarily created.
The closure 10 includes a gripping member 26 that provides an area for the user to grip when it is desired to remove the closure 10 from the port 12. The gripping member 26 is an elongated member that may include a rib 28. Although one rib 28 is shown, a greater or lesser number of such ribs may be located on the gripping member 26. The ribs 28 also function to aid in the molding process.
In the preferred embodiment illustrated in Figure 2, the gripping member 26 includes a tubular bore 30. As illustrated, the tubular bore 30 may extend for substantially the entire length of the closure 10. The tubular bore 30 provides a closure 10 that is difficult to reinsert into the port 12 after it has been removed. Thus, a tamper evident closure 10 is provided. This provides a closure 10 that allows the user to be assured that the aseptic environment within the upper tubular bore 21 of the pore 12 has not been violated.
The closure 10 includes a sleeve member 32. The sleeve member 32 is designed to cooperate with a rib member 34 located on the outer wall 36 of the tubular port 12. To this end, the sleeve member 32 has an inner circumference that is less than the outer circumference of the rib member 34. As illustrated in Figure 1, when the closure 10 seals the port 12, the sleeve member 32 surrounds the rib member 34. Because of the circumferences of the sleeve member 32 and the rib member 34, a portion 37 of the sleeve member extends outwardly around the rib. When the sleeve 32 seals the port 12 the sleeve 32 further includes fingers 38 that extend downwardly from the rib 34.
The sleeve member 32 and rib member 34 cooperate to produce an audible signal when the closure 10 is removed from the fitment 12 and the partition wall 20 has not been broken or pierced. To this end, the outward portion 37 and fingers 38 cooperate with the rib member 34 to produce a "chinese fingers" effect producing an audible snap when the closure 10 is removed from the port 12 and the partition wall 20 has not been violated.
The audible signal provides not only an easy method of determining whether the partition wall 20 has been violated but also produces a positive psychological effect to the user and the patient. The audible signal indicates to the doctor or nurse utilizing the solution container 14, and the patient who is to receive the solution, that the hermetic seal between the closure 10 and the port 12 has just been broken.
Moreover, the sleeve member 32 and rib member 34 cooperate so that the closure 10 may be removed from the port 12 through the use of only one hand. This provides a more readily usable closure 10 in that typically the nurse or doctor is only able to utilize one hand to remove the closure. The closure 10 is also user evident and does not require detail instructions.
The closure 10 is constructed from an ethylene propylene rubber. The ethylene propylene rubber provides a closure 10 that has properties similar to closures constructed from natural rubber. The preferred ethylene propylene rubber is EPDM. The closure 10 may be color coded. To expedite the identification of the solution contained in the solution container 14, the closure 10 may be colored red, green, blue or other color that identifies to the user the solution in the container.
Preferably, the closure 10 is compression molded, and the port 12 is injection molded. After the parts are molded, the closure 10 is fitted into the port 12. The closure 10 and port 12 assembly may then be steam sterilized. It is also possible to sterilize the closure 10 and the port 12 through bulk radiation sterilization and other methods known in the art.
The closure 10 provides a closure and port assembly that lends itself to mechanical assembly easily. To this end, the closure 10 provides a solid, nontacky surface that cooperates well with fitment attaching apparatus of packaging machines. An example of such an apparatus is the heat seal press head that utilizes a walking beam in a form, fill, and seal packaging apparatus.

Claims

1. A port and closure assembly for a solution container comprising a tubular port (12) for providing access to fluid within the container, the port having an elongate bore (18, 21), an outer wall defining the bore and a piercable wall (20) closing the bore, and an elastic closure (10) sealing the port and comprising an elongate top member (26), a guide member receivable in the bore (18, 21) and a sleeve member (32) surrounding the guide member and engagable around the outer wall of the port, characterised in that the piercable wall is located within the bore, the sleeve member (32) has, in an unstressed condition, an inner circumference less than the outer circumference of the portion (36) of the outer wall with which the sleeve engages, the outer wall has an outwardly projecting rib (34) with which the sleeve engages and the construction is such that an audible snap is produced as the sleeve is released from the rib during removal of the closure (10), but only if the piercable wall (20) has not been pierced.

2. The assembly of Claim 1 wherein the guide member has an outer circumference in an unstressed condition that is less than the inner circumference of the tubular port.

3. The assembly of Claim 1 or 2 wherein the guide member has a greater length than the sleeve member.

4. The assembly of any one of the preceding claims wherein the elongate top member includes an inner bore (30).

5. The assembly of any one of the preceding claims wherein the elongate top member includes at least one gripping member (28).

6. The assembly of Claim 5, wherein the gripping member is a rib (28).

7. The assembly of any one of the preceding claims wherein the closure is constructed from an ethylene propylene rubber.

8. The assembly of Claim 7, wherein the closure is constructed from a EPDM rubber.

9. The assembly of any one of the preceding claims wherein the closure is color coded.