IL38622A

IL38622A - Sterile closure assembly

Info

Publication number: IL38622A
Application number: IL38622A
Authority: IL
Original assignee: Baxter Laboratories Inc
Priority date: 1971-03-03
Filing date: 1972-01-24
Publication date: 1974-09-10
Also published as: CH539554A; ZA72496B; FR2128508A1; GB1370062A; BE778962A; DE2208704A1; CA965044A; US3730376A; IT951785B; IL38622A0

Description

Sterile closure assembly BAXTER LABORATORIES, INC.

C: -36714 TAMPE RPROOF AND REUSABLE STERILE CLOSURE ASSEMBLY Abstract of the Disclosure , A tamperproof and reusable sterile closure assembly for a container is provided including a tubular neck element which is attached to the container and a closure device having overcap and stopper portions which are adapted to be telescopically associated relative to the tubular neck element. The overcap portion of the closure device is initially frangibly connected to the tubular neck element in surrounding relationship to the stopper portion of the closure device. When the closure device is frangibly disconnected from the tubular neck element, the stopper portion of the closure device is capable of being positioned within the tubular neck element in slidable and sealed relationship therewith.

Summary of the Invention There are many instances where it is desired to dispense predetermined quantities of sterilized solution from a container over different periods of time. For example, sterilized water can be packaged in a flexible bag-like container for general use in various medical procedures as the occasion may arise. Because it is uneconomical to package small quantities of sterile solutions, it is generally desirable to use flexible solution bags having a capacity of several liters or more.

The sterile conditions that are necessary in medical procedures require^, in the case of solution bags containing sterilized solution that is used over spaced intervals, a sterile closure assembly which is both tamperproof and reusable. Prior to use of the solution bag by medical There is also a requirement that the sterilized solution within the solution bag remains sterilized during subsequent uses of predetermined quantities of the solution at spaced intervals.

While tamperproof and/ or reusable closure assemblies have been developed heretofore, there does not appear to be any previous disclosure of a tamperproof and reusable closure assembly which also remains sterile during subsequent uses thereof. There are several prior art tamperproof closure assemblies for parenteral solution container bags where, after separation of the frangible closure section from the remainder of the clo-sure device, a separate plug- end connector is inserted into an opening of the closure device for removing the contents of the solution bag. These prior art teachings, as represented, for example, by U. S. Patent No. 3, 368, 560 and U . S. Patent No. 3, 509, 879, do not have the capability of being reusable. Even where closure devices are both tamperproof and reusable, such as in U. S. Patent No. 3, 083, 858, they permit exposure of the sealing surfaces in the closure device either prior to or after separation of the frangible closure section from the remainder of the closure device, thus making it impossible to maintain a sterile condition during subsequent uses of the closure device.

Accordingly, it is an object of the present invention to provide a unique tamperproof and reusable sterile closure assembly which assures that a sterile condition will be maintained for the contents of the container during subsequent uses thereof.

Another object of the present invention is to provide sanitary gripping means for a closure device which enables a user, with one hand, associated and for holding the closure device thereafter in a manner to avoid contact with the user' s hands.

Other objects and advantages of the present invention include the provision of a closure device which is: simple in construction, easy to operate, economical, mechanically safe, adapted to mass manufacturing techniques, and is otherwise well adapted for the purposes intended.

Brief Description of the Drawings FIG . 1 is a perspective view of a solution bag which includes a tamperproof and reusable sterile closure assembly which is constructed in accordance with the teachings of the present invention; FIG . 2 is an enlarged fragmentary elevational view of the tamperproof and reusable sterile closure assembly shown in FIG . 1, and illustrated in the manner in which it is attached to the solution bag; FIG . 3 is an exploded perspective view of the tamperproof and reusable sterile closure assembly prior to association of the illustrated elements to each other and subsequent attachment to the solution bag; FIG . 4 is an enlarged fragmentary sectional view illustrating the tamperproof and reusable sterile closure assembly prior to separation of the frangible closure section from the remainder of the device; FIG . 5 is also an enlarged fragmentary sectional view of the tamperproof and reusable sterile closure assembly after frangible disconnection has occurred and the closure sections are subsequently telescopically associated relative to one another; FIG . 6 is a fragmentary perspective view depicting the preferred manner of separating or frangibly disconnecting the closure device from the remainder of the closure assembly; and FIG . 7 is also a fragmentary perspective view which illustrates the manner in which the closure device may be held, after separation from the closure assembly, to avoid contact of the sealing surfaces of the closure device with a user' s hand.

Brief Description of the Preferred Embodiment In FIG . 1 of the drawing, there is shown a flexible bag-like container, preferably made from plastic material, and commonly referred to as a solution bag. The solution bag 10 is manufactured and filled with a sterilized solution by techniques known in the art. At one end of the solution bag 10 there is provided an integral dispensing spout which may include flattened side sections 14 at opposite sides of the spout 12 to aid in the manual flattening of the spout 12 by a user in regulating the amount of solution that is metered or dispensed from the solution bag.

In order to maintain the sterile condition of the solution within the solution bag 10, there is provided a tamperproof and reusable sterile closure assembly which is adapted to be mounted within the flexible dispensing spout 12 of the solution bag 10 in snug fitting relationship therewith. The amount of liquid that is dispensed from the solution bag 10 is thus regulated and controlled by the tamperproof and reusable sterile closure assembly 16.

The structural configuration of the closure assembly 16 and the manner in which it is associated relative to th e flexible dispensing spout 12 - upper and lower parts 18, 20 both preferably injection molded from suitable plastic material. The upper part 18 of the closure assembly 16 has a tubular neck element 22 including a reduced-in- size tubular section 24 which is adapted to be snugly received within the flexible dispensing spout 12, and a tubular neck section 26 which has an outer dimension such that when the flexible dispensing spout 12 is mounted over the tubular neck section 24, the appearance that is given is that shown in FIG. 2 of the drawing where the tubular section 26 and the tubular section 24 with the flexible dispensing spout 12 mounted thereon appear to have the same outer diameter.

The tubular neck section 26 is attached, by the frangible section 28 shown in dotted lines in FIG . 3 of the drawing, to a cylindrical section 30 which forms the overcap portion of the closure device as will be described mora in detail hereinafter.

The upper part 18 of the closure assembly 16 also includes a connecting strap 32 and ring section 34 which are attached to the cylindrical section 30 as well as the sanitary gripping means 36 which is also attached to the cylindrical section 30. The connecting strap 32 is designed to be bent in order to position the ring section 34 over the reduced- in- size tubular neck section 24 prior to the assembly of the tubular section 24 within the flexible dispensing spout 12. This enables the closure device, to be discussed hereafter, to be held relative to the solution bag 10. The sanitary gripping means 36, also attached to the cylindrical section 28, will be described in conjunction with the sanitary gripping means associated with the lower part 20 illustrated in FIG . 3 of the drawing.

The lower part 20 in FIG . 3 of the drawing includes the closure de overcap portion 30 of the closure device which is presently frangibly connected to the tubular neck element 22 as above described. The lower part 20 is molded with a central disc- shaped element 38 which is formed with an annular step 40, the radial width of which is generally equal to the thickness of the cylindrical section or overcap portion 30 in order to permit the overcap portion 30 to be mounted upon the annular step 40 and secured to the disc- shaped section 38. A solvent adhesive may be utilized to secure these parts together in a manner illustrated in FIG . 4 of the drawing. When thus secured together, the overcap portion or cylindrical section 30 forms an integral attached part of the closure device 20 as can be readily appreciated.

The lower part or closure device 20 illustrated in FIG . 3 of the drawing further includes a stopper portion 42 having a plurality of sealing rings 44 integrally formed thereon, and a sanitary gripping means 46.

The stopper portion 42 and the gripping means 46 are integrally attached to opposite sides of the disc- shaped ring 38 as can be seen in FIG . 3 of the drawing. The stopper portion 42 is arranged to be mounted in the tubular neck element 22 in a manner to be presently described.

After the upper and lower parts 18, 20 are molded from suitable plastic material into a configuration such as shown in FIG . 3 of the drawing, it is desirable to first attach or secure the upper and lower parts 18, 20 together to form the closure assembly 16, and then insert the thus formed closure assembly into the flexible dispensin spout 12. The attachment of the upper and lower parts 18, 20 is accomplished by depositing a solvent adhesive, for example, on the annular step 40 of the disc- shaped together, the parts assume a position as best seen in FIGS. 2 and 4 of the drawing. It is now possible to insert the reduced tubular section 24, after the ring element 34 has been mounted thereon, into the flexible dispensing spout 12 of the filled solution bag 10. After the closure assembly 16 has been thus associated with the flexible dispensing spout 12, the closure assembly 16 is ready to be utilized in dispensing predetermined quantities of solution from the bag and for subsequently resealing the solution bag in a sterile manner as will be apparent from the discussion that is to follow.

The closure assembly 16 of the present invention provides both tamperproof and reusable features in maintaining the sterility of the solution that may be contained within the solution bag 10. As best seen in FIG. 4 of the drawing, the tamperproof feature is achieved by assuring a user that the closure assembly has been unopened. A s will now be apparent, the frangible connection 28 between the tubular neck element 22 and the overcap portion 30 of the closure device 20 gives the assurance that is de sired. At the same time, it is readily apparent that the frangible connection 28 may be easily broken to permit the closure device 20 to be removed from the tubular neck element 22 for egress of the container 's contents.

During the tamperproof condition of the closure assembly, that is, prior to breaking or severing the frangible connection 28, the stopper portion 42 of the closure device 20 is maintained in a sterile condition within the overcap portion 30 and/ or tubular neck section 26 of the tubular neck element 22. In the preferred form of the invention, the stopper portion 42 of the closure device 20 is configured and arranged to permit the engagement 44 of one of the sealing rings w. on the inner wall 48 of the tubular neck ele to make sealing contact with the inner wall 48. The stopper portion 42, because it is completely surrounded by the overcap portion 30 prior to the frangible disconnection thereof from the tubular neck section 24, is maintained in a sealed and sterile environment.

When it is desired to remove a quantity of liquid from the solution bag 10, the frangible section 28 may be broken and the closure device pivoted out of the way of the opening defined by the inner wall 48 of the tubular neck element 22. After the quantity of liquid has been dispensed, the closure device is then capable of being remounted in sterile and sealed relationship relative to the tubular neck element 22. Specifically, and as best illustrated in FIG . 5 of the drawing, the sterile stopper portion 42, itself protected by the overcap portion 30 during separation of the closure device 20 from the tubular neck section 24, is configured and arranged relative to the inner wall 48 of the tubular neck element to make slidable and sealed contact therewith during the reassembly or reapplication of the closure device 20. The overcap portion 30 is also preferably configured and arranged to make slidable and sealed contact with the outer wall 50 of the tubular neck section 24. This is achievable by the use of an integral inwardly directed foot element 52 at the free extremity of the overcap por-tion 30 which remains integral with the overcap portion 30 when the closure device 20 is frangibly disconnected from the tubular neck section 24. It will be understood that it is immaterial whether or not the outer wall 50 of the tubular neck section 26 has been exposed to a nonsterile environment since the overcap portion 30 and the outer wall 50 are not used for the purpose of sealing the solution bag 10. As has been previously indicated, subsequent resealing of the solution bag 10 is achieved through the sealing JT" It may also be desirable to form an integral gasket element 54 on the end wall portion of the tubular neck element 22, for sealing contact with an inner end surface 56 between the overcap and stopper portions , 42 respectively of the closure device 20. This is best depicted in FIG . 5 of the drawing where the sealing gasket 54 is illustrated as being in contact with the inner end surface 56 of the closure device between the overcap and stopper portions 30, 42 respectively of the closure device 20.

It is important that in removing and reapplying the closure device 20 relative to the tubular neck element 22, that there be no contact between a user' s hand and the sterile sealing surfaces of the closure device 20.

While the overcap portion 30 of the closure device 20 serves to protect the stopper portion 42 from inadvertent contact by a user 's hand, it is, of course, possible for a user to touch the stopper portion 42 and thereby destroy the sterile aspects of the closure device.

In order to facilitate removal and reapplication of the closure device 20 as well as holding of the closure device 20 in the hand of a user, without destroying the sterile conditions of the closure, the finger engaging tabs 36 and 46 may be advantageously employed. As illustrated in FIGS. 6- 7 of the drawing, the finger engaging tabs 36, 46 are integrally attached to outer side and end wall surfaces 58, 60 respectively of the closure device 20. Each finger engagin tab is generally rectangular in shape with spaced semi-cylindrical segments 62 on opposite faces of each of the finger engaging tabs 36, 46 to facilitate gripping thereof. It will be noted that the finger engaging tabs 36, 46 are generally perpendicularly offset from one another with the finger engaging tab 36 being attached to the outer end wall surface M Finger engaging tab 36 is also substantially normally directed relative to the axis of the closure assembly 16 as can best be seen in FIG. 2 of the drawing. With this construction, the finger engaging tab 36 provides good leverage for the user in removing the closure device 20 from the remainder of the closure assembly 16 by breaking or tearing the frangible connection 28. The manner of removing the closure device 20 will be best understood by reference to FIG . 6 of the drawing.

In addition to removing the closure device 20 by the use of the finger tab 36, the present invention also contemplates holding the closure de-vice 20 by the finger engaging tab 46. With reference to FIGS. 6- 7 of the drawing, it will be seen that the finger engaging tab 36 is designed to be gripped by the thumb and forefinger of a user in frangibly disconnecting the closure device 20. The finger engaging tabs 36 and 46 are arranged relative to one another such that by slight pivoting movement of the closure device 20 following gripping of the finger engaging tab 36, the forefinger and middle finger of a user 's hand can be brought into gripping contact with the finger engaging tab 46 as is illustrated in FIG . 7 of the drawing.

Removal and reapplication as well as holding of the closure device 20 is thus facilitated by the use of means such as the finger engaging tabs 36 and 46. While the herein illustrated finger engaging tabs 36 and 46 are preferably employed, it will be apparent that other types of removing and holding structures may be utilized. For example, it is conceivable that the finger engaging tabs 36 and 46 may be joined to one another by a connecting strap which can be used to both frangibly disconnect and hold the closure device. Further, in lieu of the finger engaging tab 46, a knob means may replaced by finger engaging depressions formed in the closure device 20. Other similar examples, whether of unitary construction or separated as in the preferred embodiment, will be readily apparent.

From the foregoing, it will now be appreciated that the present invention contemplates a novel and unique tamperproof and reusable sterile closure assembly for protecting the sterility of the contents of a container with which the closure assembly is associated. 38622/3

Claims

1. A tamperproof and reusable sterile closure assembly for containers comprising a tubular neck element having inner and outer walls and being attached to a container for egress of the contents thereof through the opening defined by the inner wall of the tubular neck elementt and a closure device for protecting the sterile condition of the container's contents during subsequent opening and closing of the container, said closure device including stopper and overcap portions for telescopic association relative to the inner and outer walls of the tubular neck element; said overcap portion completely surrounding the stopper portion and being initially frangibly connected to said tubular neck element throughout its circumferential extent, said closure device when frangibly disconnected from said tubular neck element enabling telescopic association of said closure device relative to said tubular neck element, means for frangibly disconnecting said closure device from said tubular neck element and subsequently both for holding and telescopically associating said closure device relative to ss?id tubular neck element, said means including separate finger engaging tabs connected to an outer end and outer side wall surfaces of said closure device and said stopper portion being configured and arranged to engage said inner wall of said tubular neck element in slidable and sealed relationship therewith while said overcap portion is mounted over said outer wall of said tubular neck potion as said closure device is telescopically associated relative 38622/3

2. · The closure assembly as defined in claim 1 wherein said overcap portion is configured and arranged to engage the outer wall of the tubular neck element in slidable and sealed relationship therewith.

3. The closure assembly as defined in claim 1 wherein said overcap portion and said tubular neck element are frangibly connected in the vicinity of the free extremities thereof.

4. · The closure assembly as defined in claim 3 wherein the frangible connection extends from the inner surface of the overcap portion to the outer wall of the tubular neck element.

5. · T e closure assembly as defined in claim 1 wherein the stopper portion is arranged to engage the inner wall of the tubular neck element when the closure device is frangibly connected to the tubular neck element.

6. TJie closure assembly as defined in claim 1 wherein a connecting strap is provided between the tubular neck element and the closure device to prevent separation thereof after the closure device is frangibly disconnected from the tubular neck element*

7. * The closure assembly as defined in claim 1 wherein an end wall portion of the tubular neck element includes sealing means for engaging ant inner end surface of the closure device between the overcap and stopper portions thereof.

8. The assembly of claim 1 wherein said separate tab connected to said outer side wall accommodates the fingers for gripping and removing said closure device from said container 38622 removal from said container and for aiding in the reapplication of said closure device to said container, said finger engaging tabs being arranged to permit gripping of the former by the thumb and forefinger of a user and then gripping of the latter by the forefinger and middle finger of the user after slight pivoting movement of said closure device relative to said user's hand. For the Applicants ERS -1