EP0836465A1

EP0836465A1 - Multi-purpose vials for use in hypodermic administrations and drug delivery systems

Info

Publication number: EP0836465A1
Application number: EP96921344A
Authority: EP
Inventors: Peter C. Carveth; Stanley F. Pytel
Original assignee: Abbott Laboratories
Current assignee: Abbott Laboratories
Priority date: 1995-06-07
Filing date: 1996-06-05
Publication date: 1998-04-22
Also published as: CA2223238A1; JPH11507255A; AU6258996A; WO1996040037A1

Abstract

The present invention relates to multi-purpose vials and a process of making them. The multi-purpose vials may be used in hypodermic administrations of drug or as part of a drug delivery system.

Description

MULTI-PURPOSE VIALS FOR USE IN HYPODERMIC ADMINISTRATIONS AND DRUG DELIVERY SYSTEMS

This application is related to co-pending application titled "A Two-Step Automated Process for Applying Peelable Seals to Containers".

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a multi-purpose closure system for a vial with a body engagement portion for use in a drug delivery system and a peelable port cover for use in hypodermic administrations.

2. Description of the Prior Art Medical hospitals as well as doctors' offices require vialed medicaments for at least a couple of uses. First, vialed medicaments may be used as an integral part of a medicament /diluent system, such as the ADDVantage® drug delivery system sold by Abbott Laboratories (Abbott Laboratories, Abbott Park, II. 60064). Secondly, vialed medicaments , whether aqueous or powdered, may be removed from the vial, via cannula, and used for hypodermic, e.g., intramuscular administration, to a patient. Stoppered vials are commonly used in the pharmaceutical industry for supplying sterile drugs. Medicaments stored in vials normally are administered in a health care environment by inserting a cannula through a swabbed stopper or diaphragm and removing the medicament or drug before injection into the patient.

If the medicament is a powder, a diluent may be necessary to liquefy or dissolve the medicament prior to its' removal from the vial. This procedure may present a risk of contamination.

Once the medicament is removed from the vial by a cannula the medicament may be administered directly to the patient by hypodermic administration or into a Y-site in a drug delivery system, such as an intravenous set. US 4703864 to Larkin et al., discloses a molded plastic cover for a container which has a removable cap portion and a means for connecting the vial to a drug delivery system. Upon removal of a tear strip, the cap portion may be removed from the device and the vial inserted into a diluent bag of a drug delivery system. The end wall of the cap portion has a thin molded plastic diaphragm which allows a cannula to be inserted through the top of the end wall and into the vial. However, inserting a cannula through the plastic piercable diaphragm has inherent disadvantages. Having a piercable diaphragm presents a quality control problem in that it is difficult to get uniform diaphragms injection molded. Some diaphragms may have a diameter as small as sixty to eighty one-thousandths of an inch. The diaphragm diameter is usually at least as large as the diameter of the canulla piercing it. Also the thickness of some diaphragms may be as small as one one-hundredth of an inch. In addition, piercable plastic diaphragms is not desirable. A cannula inserted through the piercable diaphragm may cut a plug of plastic out of the diaphragm. US 4614515 to Tripp et al., also discloses a stoppered drug vial and in addition, has a peelable seal. The peelable seal covers the outer surface of a piercable diaphragm. The piercable diaphragm is made from medical grade plastics such as polypropylene, polyvinyl chloride or polyethylene. The peelable adhesive seal may be removed and a cannula inserted through the piercable diaphragm. However, the piercable diaphragm may have to be swabbed with alcohol prior to cannula insertion. Furthermore, the healthcare administrator still must place a cannula through a plastic diaphragm. Yet another disadvantage is that the target zone may not be readily viewable through the plastic diaphragm.

The present invention relates to multi-purpose vials which can be used for hypodermic administrations of drugs or be a part of drug delivery system. A cannula may be inserted into a vial though an access opening once a peelable seal is removed. In addition, the vial itself may be used as a part of a drug delivery system. This allows hospitals as well as doctors offices to stock one type of vial as opposed to different types to satisfy the needs listed above.

SUMMARY OF THE INVENTION

The present invention relates to multi-purpose closure system for vials suitable for hypodermic administration of a medicament or as part of a drug delivery system comprising, a body engagement portion for engagement to a drug delivery system, and a peelable port cover when removed provides access to the vial via a cannula.

In addition, the present invention relates to a two-step automated process for applying peelable port covers to a cap portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a vial assembly employing teachings of this invention.

FIG. 2 is a perspective view of the vial assembly of FIG. 1 after the top portion of the cover and the related tear strip and pull ring have been removed.

FIG. 3 is a front view of a vial assembly employing the teachings of this invention.

FIG. 4 is a sectional view of one-half of the vial and cover of FIG. 1 , as taken along a radius, with the other half in elevation (generally along planes 5 - 5 of FIG. 3).

FIG. 5 is an exploded perspective view of the vial assembly of FIG. 3.

FIG. 6 is a view similar to FIG. 5 illustrating another manner of use of the covered vial of FIG. 3. FIG. 7 is a partial cross sectional view of a peelable port cover. DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a multi-purpose closure system for a vial which may be used in intravenous drug delivery systems and may also be used where hypodermic administrations are necessary. An example of a multi-purpose vial is shown in Figure 1. The multi-purpose vial comprises a vial (10) with a peelable port cover (44) and a body engagement portion (31 ). The peelable port cover (44) is applied to a first or cap portion (30) which covers the top end of the vial (10).

The cap portion (30) may have an end wall (40), an annular skirt (41), and an access port (43). For example, the cap portion (30), the peelable port cover (44), surround and hermetically seal the top portion of the vial (10). The access port (43) may be hermetically sealed by a peelable port cover (44) placed on the end wall (40) of the cap portion (30).

Removal of the peelable port cover (44) from the end wall (40) will provide access to a removable stopper. The removable stopper can then be accessed by a cannula through the access port (43). The access port (43) is typically centered above the removable stopper.

The removable stopper is placed within the access opening of the vial. The removable stopper is typically made of an elastomeric material, such as rubber. The multi-purpose vials of the present invention are

"multi-purpose" in the sense that the body engagement portion (31) contains a mechanism for connecting to a diluent bag for use in an intravenous drug delivery system while the peelable port cover (44) provides access to the vial (10) via a cannula. US Patent No. 4,614,515 to Tripp et al., and US Patent No.

4,703,864 to Larkin et al., are both hereby fully incorporated by reference.

The peelable port cover (44) may be applied to a molded cap portion (30) that has an access port (43). The access port (43) may be designed to provide access to a rubber stopper (14) which sits in the access opening (13) of a vial wherein once the peelable port cover (44) is removed, a cannula may be inserted through the rubber stopper and into the vial (10). This prevents the need to have to pierce through plastic covers or plastic diaphragms. Generally, such plastic covers and plastic diaphragms are made of materials such as polypropylene, polyvinyl, and polyethylene, or the like.

Peelable port covers are typically multi-layered membranes. Such multi-layered membranes generally include metal foils bonded to paper and/or polymer layers. Referring to FIG.7, the peelable port cover (44) typically will contain a pressure sensitive adhesive layer (70), a sealant layer (72), a metal foil layer (74), and a heat-resistant layer (76). Tie layers (78) may be used to bond the different layers together to create a multi-layer membrane. The adhesive layer and the sealant layer are unique in that they can be used together to provide a fast, accurate application which results in a peelable port cover being sealed to a container.

The pressure sensitive adhesive layer (70) is used to temporarily hold the peelable port cover (44) in place on the cap portion (30) prior to sealing the peelable port cover (44) to the cap portion (30) by induction heat. Preferably, the peelable port covers are provided on a carrier web (69) which contains large quantities of port covers. Once removed from the carrier web (69) by manual or automated processes, the peelable port cover (44) is temporarily placed on the end wall (40) or the edge of the annular skirt section (41) when no end wall is present. The adhesive layer of the peelable port cover adheres the port cover to the end wall or annular skirt. Preferably, the process used is an automated process. A sufficient amount of adhesive should be applied to hold the peelable port cover in place prior to the inductively sealing. The pressure sensitive adhesive is not restricted to a specific type, but may be any one of acrylic, rubber, vinyl and silicone types. The sealant layer (72) will typically be of a polymer, such as a low density polyethylene or ethylene vinyl acetate material. Preferably, the sealant layer (72) will be of the same material as that to which it seals. The sealant layer (72) may be heat sealed to the end wall (40) or the annular skirt section (41), when no end wall (40) is used. Upon removal of the peelable port cover from the end wall (40), the sealant layer is welded to and remains on the end wall (40). The peelable port cover will tear in layers other than the sealant layer, such as the tie layers. An altenative is to make a coextrusion sealant layer where the sealant layer has materials of different densities. Removal of the peelable port cover will result in one of the coextrusion materials welding to the end wall and the other density material being removed with the peelable port cover. The sealant layer separates at the interface of the different materials in the sealant layer that have different densities. In addition, once the peelable port cover is removed from the cap portion it cannot be resealed.

Alternatively, the sealant layer (72) may be a polymer blend. For example, the sealant layer may be blend of all or any of polypropylene, ethylene vinyl acetate, or polyethylene. For example, polypropylene and polyethylene may be mixed together to form a polymer blend. In the polymer blend, it is preferable that one of the polymers be the same material as the container. For example, the polypropylene in the polymer blend will seal more securely to a polypropylene container than will the polyethylene in the polymer blend.

The heat-resistant layer comprises the top layer of the multi-layered membrane when the peelable port cover is sealed to the cap portion. Typically, the heat-resistant layer is made of polyesters. The metal foil layer is heated by both heat and pressure from the induction sealer. The heat from the metal foil melts the sealant and welds it to the cap portion. Typically, the metal foil is made of aluminum.

The peelable port cover (44) is inductively sealed to the cap portion (30). Typically, the temperature between the sealant layer and the cap portion during the induction sealing process is from about 250° to about 350° Fahrenheit (F). The thickness of the peelable port cover may vary but typically is from about one-one thousandths of an inch to about three-one thousandths of an inch. The multi-purpose vial of the present invention may be a glass vial or a molded plastic vial. Molded plastic vials must be made of a material such that it can be sterilized by at least one acceptable sterilization technique. Preferably, the multi¬ purpose vial is glass. The multi-purpose vial may be sterilized by one of several processes, such as but not intended to be limited to, gamma irradiation, and ethylene oxide. For example, the sterilization of the vial can be done by gamma radiation with subsequent aseptic filling with the medicament into the vial. The cap portion (30) may be a molded plastic which surrounds at least a portion of the top of the glass vial. Typically, the cap portion (30) will have an end wall (40), an annular skirt (41), and an access port (43). An alternative is to have a plastic cover with no end wall. In such a plastic cover, the peelable port cover will be sealed to edge of the annular skirt.

The body engagement portion may be designed to provide a gripping surface for the end user as well as to provide a site of attachment to a diluent bag. Another example of a multi-purpose vial is shown in FIGS.

2-6 of the drawings wherein, a vial assembly (8) includes a vial (10) having a threaded finish end (12) with an access opening (13) closed by a hollow removable, elastomeric stopper (14).

With further reference to the other Figures of the drawing, the vial (10) is enclosed by a cover (20) and a shroud (22) which join one another at an overlap joint (24). The cover and shroud are further secured together by an adhesive label (26) which spans the joint (24). The cover may be a unitary plastic molding of a suitable plastic, such as a polypropylene or polyethylene, which may be accurately moldable to close tolerances, dimensionally stable, relatively rigid (inelastic) and frangible or tearable. The shroud portion (22) may be of similar materials but typically is one which is more flexible and resilient.

The cover (20) includes a cap portion (30), a second or body engagement portion (31), a tear strip (32) intermediate the portions (30) and (31) and joined thereto by tear detail joints (33) and (34), and a pull ring (35). A section of the pull ring (35) at one side is joined to the tear strip through a force transfer element (36).

The cap portion (30) typically includes an end wall (40), an access port (43), and an annular skirt section (41) which surrounds and extends slightly below the threaded neck of the vial. Several seating ribs (42) are provided on the inner surface of the cup. These ribs are of a radial and axial extent to provide an abutment stop for the finish end of the vial, as best seen in FIGS. 4 and 6, to avoid pressure contact between the outer end surface of the stopper (14) and the inner surface of end wall (40). This precludes any sticking of these elements to one another.

The cap portion (30) may in addition, have at least one circumferential ring embossed on the top of the end wall (40) which will be covered by the peelable port cover (44). The circumferential ring is concentric and encircles the access port. The embossed circumferential ring and peelable port cover will remain a raised section while the rest of the peelable port cover remains flat against the end wall. The raised section thereby provides visual verification that the peelable port cover is sealed intact to the end wall. Once the peelable port cover is partially or fully removed, any removed section of the peelable port cover will flatten out and not show an imprint from the circumferential ring. In lieu of one or more circumferential rings, other area or areas of the end wall, that is to be covered by a peelable port cover, may be embossed to provide the same function.

The access port (43) has been made by machine punching a hole in the end wall (40). In lieu of machine punching a hole in the end wall, the access port (43) may be injection molded to provide for an access port in the end wall (40). The access port (43) may be any size deemed desirable but it is preferable that sufficient end wall (40) remain for attachment of the peelable port cover (44). If the cap portion (30) has no end wall (40), then the peelable port cover (44) may be attached to the annular skirt section (41 ).

The access port (43) may provide direct access to the stopper (14). The access port (43) allows for the addition of material into or the extraction of material from, the vial (10). The access port (43) prevents the need for a syringe needle to penetrate the end wall (40) or any other part of the cap portion (30).

The access port (43) allows for the easy addition of additional drug and/or diluents into the vial. This may be accomplished by the complete or partial removal of a peelable port cover (44).

The body engagement portion (31) may be formed with a shoulder (46) which may serve as a stop seat for the shoulder of the vial. The depending cylindrical portion (47) fits closely about the cylindrical main body of the vial (14) and includes a pair of annular sealing ridges (48) for tight sliding contact with the vial (10) to provide effective barriers to entry of bacteria or other organisms. Thereby the cover (20) maintains sterility on and around the neck and finish end portion of the vial. The sealing ridges (48) may be continuous annuli or may have short interruptions to permit escape of entrapped gas during assembly of the cover (20) on the vial (10). An annular array of ratchet teeth (49) is provided on the outer surface of portion (47) for interlocking engagement with complementary teeth of an inlet port on a diluent bag or other dispensing container in one mode of use of the covered vial, as further described in the aforementioned U.S. Pat. No. 4,614,515.

The tear detail (34) is defined by a thin frangible wall joint section at the apex of a V-shaped groove in the outer portion of cover (20), as illustrated. This tear joint completely encircles the cover. The frangible tear detail (33) is formed by a thin wall section between two offset sharp corners defined between an external shoulder (50) at the upper edge of the tear strip (32) and an internal shoulder (51) at the lower edge of the skirt section (41) of the cap portion (30). (As used herein, "upper" and "lower" have reference to the orientation of a vial unit with the cap and access opening upward as seen in FIGS. 3, 4, and 6). The tear detail (33) is interrupted by a shoulder or thickened wall portion (54) which forms a tear stop. This insures that the cap portion and tear strip will remain attached to one another upon removal from the vial assembly (8), see FIG. 2. In the alternative, as seen in FIG. 1 , the pull ring (35) and tear strip (32) may completely be separated from the cap portion.

The pull ring (35) may be disposed around the cover (20), circumscribing the cap portion (30). With the ring spaced beneath the upper surface of the end wall (40), this end surface and the adjacent upper portion of the skirt wall (41) remain clear and unobstructed, as seen in FIGS. 3 and 4. This arrangement permits convenient handling of the covers and convenient engagement by assembly equipment and installing tools during assembly of the cover with the vial. The arrangement also provides easy access to the peelable port cover (44) whereby it can be removed and the vial (10) accessed via cannula through the access port (43). The end wall (40) defines a reference surface in a predetermined relationship to the remainder of the cover. Thus, it provides a flat stable surface, disposed generally normal to the longitudinal center axis of the cover and of the assembly, on which each cover or the respective assembly may rest while being conveyed and which may be engaged by pressing devices when telescoping the cover and vial together. Having the ring spaced beneath the end wall surface further exposes a portion of the cylindrical skirt wall (41) for gripping of the cover and particularly accommodates engagement by conical engagement fixtures or other fixtures or tools which engage the cover over the upper end. While certain embodiments have been illustrated and/or described in detail, it will be understood that the invention is not limited to those embodiments. Accordingly it is intended by the claims herein to cover any modifications and other embodiments which incorporate those features which embody the essential aspects of this invention.

The present invention also relates to a process for applying peelable port covers to containers and other items. The peelable port covers are applied in a two-step process which increases the speed of manufacturing as well as provides sterile access sites to the stoppered vials. The access sites to the containers are protected by the applied peelable port cover. It is desirable for a process for mass producing such containers that it be fully automated. A fully automated system may apply from about 60 to more than 300 peelable port covers to cap portions per minute of operation. It is also desirable that the applied peelable port cover remains consistent for a minimum of one year, i.e., the peelable port cover does not prematurely peel off during handling, distribution, and packaging.

The adhesive layer/sealant layer cooperation in the process is integral to the multi-purpose closure system for a vial and to the process of applying the peelable port covers. The two-step process includes a pressure sensitive labelling machine which places the peelable port cover on the cap portion. The labelling machine, such as the Label-Aire®, Model 2114 Tamp-Blow Applicator (Label-Aire Inc., Fullerton, Ca., 92633), automatically peels the peelable port cover from the carrier web and places it on a holding pad where it is held in place by a vacuum. The holding pad extends toward the cap portion at which time the air flow is reversed and the peelable port cover is blown onto the cap portion thereby enclosing the access port. The peelable port cover is secured to the end wall by the pressure sensitive adhesive layer of the peelable port cover. Peelable port covers can be obtained from a variety of vendors. One particular port cover used with the multi-purpose closure system for vials of the present invention is a port cover from Outlook Packaging (Outlook Packaging, Oak Creek, Wi. 53154).

The cap portion with the adhered peelable port cover then is passed under an induction sealing head, such as the The Lepel Electronics Cap Sealing System (Lepel Co., New York, NY. 11378) or the induction sealer from Enercon (Enercon Industries Corp., Menomee, Wi., 53052-0773). Induction heating typically involves passing a high frequency alternating current through a copper coil to create oscillating magnetic fields whereby the magnetic fields heat the metal foil layer in the peelable port cover. The heating of the metal foil layer is combined with pressure to melt the sealant layer which burns through the pressure sensitive adhesive layer and seals to the cap portion.

Claims

What is claimed is:

1. A multi-purpose closure system for a vial with a removable rubber stopper comprising:

a body engagement portion, said body engagement portion having a connection means, said connection means capable of attachment to a drug delivery system;

a cap portion having a cover, said cover having an end wall, an annular skirt, and an access opening, said access opening centered above said removable stopper; and

a peelable port cover sealed to said end wall, said peelable port cover enclosing said access port, removal of said peelable cover providing access to said stoppered vial.

2. A multi-purpose closure system for a vial of claim 1 wherein, said cover is a multi-layered membrane.

3. A multi-purpose closure system for a vial of claim 2 wherein, said multi-layered membrane comprises a heat- resistant layer, a metal foil layer, a sealant layer and an adhesive layer.

4. A multi-purpose closure system for a vial of claim 1 wherein, said body engagement portion further comprises an annular array of ratchet teeth.

5. A multi-purpose closure system for a vial of claim 1 wherein, said vial further comprises a shroud.

6. A multi-purpose closure system for a vial of claim 1 wherein, said cap portion further comprises at least one embossed region on said end wall.

7. A multi-purpose closure system for a vial of claim 6 wherein, said end wall further comprises at least one circumferential ring which is concentric and encircles said access port.

8. A multi-purpose closure system for a vial of claim 1 wherein, said vial is composed of glass.

9. A multi-purpose closure system for a vial of claim 1 wherein, said vial is composed of a molded plastic.

10. A multi-purpose closure system for a vial with a removable rubber stopper comprising:

a cap portion having a cover, said cover having an annular skirt, and an access opening, said access opening centered above said removable stopper; and

a peelable port cover sealed to said end wall, said peelable port cover enclosing said access port, removal of said peelable cover providing access to said stoppered vial..

1 1. A multi-purpose closure system for a vial of claim 10 wherein, said cover is a multi-layered membrane.

12. A multi-purpose closure system for a vial of claim 11 wherein, said multi-layered membrane comprises a heat- resistant layer, a metal foil layer, a sealant layer and an adhesive layer.

13. A multi-purpose closure system for a vial of claim 10 wherein, said body engagement portion further comprises an annular array of ratchet teeth.

14. A multi-purpose closure system for a vial of claim 10 wherein, said vial further comprises a shroud.

15. A multi-purpose closure system for a vial of claim 10 wherein, said vial is composed of glass.

16. A multi-purpose closure system for a vial of claim 10 wherein, said vial is composed of a molded plastic.