KR100385760B1 - Package - Google Patents

Abstract

packing of sterile liquids. SUBSTANCE: package has plastic bottle, stopper driven into pour-out hole of bottle for removing and member which can be hooked up. This member is protected from accidental engagement by ring wall projecting upwards from edge of cover member over periphery. Wall of cover member is provided with holes to prevent accumulation of liquid at sterilization. EFFECT: reduced to minimum accidental engagement of hook-up member and getting of contaminants into package. 8 cl, 10 dwg

Description

Package {PACKAGE}

In the medical field, sterile fluids such as pharmaceuticals, formulations, sterile saline solutions and the like are often required for the treatment of patients. Such sterile fluids are generally contained in bottles made of glass that do not cause chemical action and do not contaminate or degrade the sterile fluid.

The vial is usually closed by a rubber stopper inserted into the bottle's spout. The stopper is designed to be penetrated by the needle of the hypodermic syringe and the injection spike of the infusion set or the like to enable the contents of the bottle to be taken out. The stopper may be removed to release the contents of the bottle.

To hold the stopper in place, a cap made of aluminum or similar thin sheet metal is pressed onto the top of the stopper and the bottle. In order to access the plug to penetrate or remove it, the cap is torn partially or fully.

Despite the wide range of uses, such packages have many disadvantages. For example, glass bottles are relatively heavy. In addition, glass is a relatively fragile material and glass bottles are fragile. This is especially true when the volume of the bottle exceeds 100 ml. In order to reduce breakage accidents during loading, such glass bottles should be carefully packed with inserts that isolate them from each other. Since such an insert occupies a certain volume, the number of bottles that can be accommodated within a given volume is reduced, thus increasing the cost of transporting the bottle.

Also, tearing the aluminum cap can cause problems such as sharp edges remaining where the aluminum cap is torn. Such edges are sharp enough to damage surgical gloves or human skin, which is an obvious disadvantage in the medical field, especially in areas where the risk of infection should be minimized.

In addition, in many European countries, waste has to be sorted before it can be disposed of. Having a metal cap and rubber stopper on the vial means that the package comprises three different kinds of materials (glass, metal, plastic) that must be treated separately.

Different approaches to sterile fluid vessels have been tried and these have differed in their success. In one known product, a plastic bottle with a screw cap with a stopper was used. The cap is also removed from the bottle when the screw cap is removed. This avoids the problems associated with the use of the vial, but the package is incompatible with the injection process and cannot be used with a hypodermic syringe needle like a standard package in which a hypodermic syringe needle or the like is used.

In another proposal described in German Patent No. 19500460, the plastic bottle is provided with an injection molded cap covered with plastic foil. In this proposal, the bottle's spout has no cap and the main seal of the bottle is made by an integrally formed closing wall which is penetrable by cannula or spike but otherwise not open. The cap is fitted on the closing wall. When access to the contents of the bottle is required, the foil must be removed and both the cap and the closing wall penetrated, sufficient force is required to penetrate both the cap and the closing wall and the cannula or spike is There is a risk of particles being clogged or material being drawn off from the contents of the bottle.

It is also known to use plastic bottles with conventional caps held by aluminum caps. This still has the problem of sorting out various parts of the package before it is discarded as waste or leaving sharp edges when the aluminum cap is torn.

Other forms of closure manufactured by Stelme, France, are sold under the trademarks "Monobloc" and "Duobloc". "Monobloc" includes a plastic cap that fits over the neck and stopper of a conventional glass bottle. The rupture allows access to the stopper and the entire cap can be removed if necessary. “Duobloc” is similar, but with a threaded insert that snaps onto the neck of the vial and the rest of the cap is screwed with the insert. However, these use glass bottles with this problem and must be sorted before various parts of the package can be processed.

The present invention relates to a package, in particular a package for sterile fluid.

1 is a partial side cross-sectional view of a package according to a first embodiment of the present invention.

2 is a cross-sectional view of the stopper.

3 is a cross-sectional view taken along the line III-III of FIG.

4 is a cross-sectional view taken along the line IV-IV of FIG.

5 is a side view of a cap used in a package according to a second embodiment of the present invention.

6 is a plan view of the cap of FIG.

FIG. 7 is a cross-sectional view taken along the line VIII-VIII in FIG.

8 is a side view of another cap.

9 is a cross-sectional view of another bottle.

10 is a partially enlarged view of FIG. 9.

According to a first aspect of the present invention, there is provided a container having a spout, a stopper removably inserted into the spout, and a cap over the stopper, wherein the container and the cap are provided with a package formed of a plastic material. do.

By forming the container and cap of the package from a plastic material, the problems of weight and breakage associated with the glass container are avoided. In addition, there is no need to classify the container and cap portions of the package into glass, metal and plastic before disposal.

The stopper is generally formed of an elastic material and preferably of plastic. The stopper may be formed of rubber.

In one preferred embodiment, the container is a bottle. This is good because sterile fluids are typically contained in glass bottles, and it is desirable to avoid confusion of some end users by providing the material in the same form even if the package is made of different materials.

Preferably, the container and the cap have auxiliary screws. This provides a simple and effective way of securing the cap on the container.

In addition, it is preferred that the cap be provided with an open confirmation feature to reduce the risk of fluid being administered from an open and reclosed package. Such opening and reclosing can result in fluids that have lost sterility, or can cause deterioration or contamination of some types of fluids. One suitable form of the tear open feature is a member that must be removed from the cap and removably attached to the cap before the cap is removed. The absence of such a signal is a signal that the package was once opened and should not be used.

In a preferred embodiment, the cap includes a removable portion that can be removed to access the stopper.

In such a cap, the closure can be opened in many ways. The removable portion may be removed for access to the stopper while keeping the stopper in place. Afterwards, the plug can be penetrated by a hypodermic syringe needle or the like. Alternatively, the entire cap may be removed (which may involve the removal of an opening confirmation feature) and allows access to the entire closure. This may be useful, for example, if an injection spike wider than the removable portion is used. As another example, the entire cap and stopper can be removed to allow ejection or a quill or straw to be inserted with an autoinjector inserted.

Preferably the cap has a engageable member actuated by a user to remove the removable portion. This facilitates the removal of the removable portion.

In a preferred configuration, the engageable member includes a ring spaced upwardly from the removable portion. This allows the user of the package to place a finger under the joinable member to facilitate operation.

It is also preferred that the cap includes at least one protrusion that acts as a pivot with respect to the engageable member. If no pivot is used, the force applied by the user on the engageable member is simply transmitted to the removable portion. However, if a pivot point is provided, the lever action effect can magnify the force applied on the engageable member and thus can easily remove the removable portion.

In a preferred embodiment, the joinable member protrudes from the cap, so there is a risk that the member is actuated to remove the member that is accidentally removed by accident. Thus, the cap is preferably provided with a wall extending around the periphery of the joinable member to protect it from accidental operation or entanglement with another package, for example. As a result, the joinable member is "shrouded" and there is less opportunity for the member to act accidentally. If the joinable member is a pull ring, it is advantageous that such pull ring is protected around the entire circumference.

It is also preferred that the wall has at least one through opening. Most medical sterile fluid packages are sterilized by a high pressure steam sterilizer in a steam environment, and the steam can be condensed with water on the package as the environment in the high pressure steam sterilizer is cooled. If the wall is not broken, a cup can be formed in which water is collected. An opening is provided in the wall to allow water to escape.

Preferably, the cap has a member that engages the stopper when the package is closed to protect the confined area of the stopper from contamination. Advantageously, the member is an annular member extending downward from the cap and abuts the top surface of the stopper. The annular member provides a physical barrier against contaminants and keeps the defined area sterile. Preferably, the integrity of the seal produced by the member is achieved by elastically deforming the portion of the mating stopper.

The idea of providing a wall to protect the joinable member from accidental operation is considered to be an independent advantage of the present invention, and according to a second aspect of the present invention a container having a spout and a removably inserted into the spout A stopper, a cap overlying the stopper, the cap being removable for access to the stopper, a joinable member actuated by a user to remove the removable part, accidentally actuated or entangled; A package is provided that includes a wall extending around the periphery of the joinable member to protect it from.

It is also preferred that the wall has at least one through opening for the reasons mentioned above.

In another preferred embodiment, the spout has an inner diameter and the container has an area below the spout having an inner diameter smaller than the inner diameter of the spout. The shrinkage so formed prevents the plug from being pushed into the container, for example when a force is applied by a hypodermic syringe or the like. When the stopper is pushed downward, it is abutted on the shrinkage, which prevents further downward movement.

The idea of providing such a constriction is considered to be an independent advantage of the present invention, and according to a third aspect of the invention therefore comprises a container having a spout for receiving a closure, the spout having an inner diameter, the container having A package is provided having an area below the spout having an inner diameter smaller than the inner diameter of the spout to prevent the plug from moving from the spout to the area.

Now, preferred embodiments of the present invention are described by way of example only with reference to the accompanying drawings.

1 shows a package 10 according to a first embodiment of the invention. Package 10 includes a plastic bottle 20, a stopper 40 and a plastic closure cap 50. The stopper is preferably formed of a thermoplastic polymer material, but may also be formed of other synthetic polymer materials or synthetic rubber (eg chlorobutyl rubber) or natural rubber.

The bottle 20 has a body 22, a shoulder 24, and a narrow neck 26 extending from the shoulder. The other surface of the neck has an outer screw 28 formed. The lip 30 projects radially outward from the neck 26 under the outer screw 28.

The inner surface of the neck is substantially cylindrical. However, the inner surface also has a diameter reducing portion 32. The purpose of this diameter reducing part is to prevent the stopper 40 from being pushed into the neck 26 when a force is applied to the stopper, for example by a hypodermic syringe needle or the like. The diameter reducing portion may have a diameter that is only slightly smaller than the diameter of the rest of the neck as shown in FIG. 1, or the diameter may be substantially smaller as shown in FIGS. 9 and 10.

The stopper 40 has a generally cylindrical body 42, the radius of the body being slightly larger than the radius of the inner surface of the neck of the bottle. This forces the body 42 of the stopper 40 to fit into the neck 26 of the bottle. Thus, the cap seals the bottle. The lower end of the body 42 has a chamfer 44 to assist in the insertion of the body 42 into the neck 26 of the bottle 20.

At the upper end of the body 42 is a flange 46. The flange 46 rests on the top of the neck of the bottle when the stopper 40 is fully inserted.

In addition, a hollow hole 48 is formed in the lower surface of the stopper 40. The hollow hole 48 extends upwardly from the bottom toward the top of the stopper 42, and consequently the thickness of the central portion of the stopper 42 is considerably thinner than the length of the stopper. This allows the plug to be easily penetrated by subcutaneous syringe needles, injection spikes, and the like.

The closing cap 50 is attached to the top of the neck 26 of the bottle. The cap has a lid member 52 overlying the stopper 40 and an annular skirt 54 extending downward from the edge of the lid member 52.

The skirt 54 has an inner screw 56 formed on the inner surface, and the inner screw 56 engages an outer screw 28 formed on the neck 26 of the bottle to hold the closure cap in place.

A ring 57 is detachably attached to the lower end of the skirt 54. A ring 57 engages under the lip 30 on the neck 26 of the bottle. Thus, the removable ring 57 acts as a tamper-evidencing element. In order to remove the cap 50 from the bottle 20, it is first necessary to remove the ring 57 from the cap 50 and the removed ring informs the user that the package 10 has been opened.

The underside of the lid member 52 has an annular member 58 extending downward. The lower end of the annular member abuts the top surface of the stopper 40 and ensures the integrity of the package 10. The annular member 58 also surrounds the central area of the top surface of the closure and prevents contamination. Since the central area of the top surface of the closure is the portion which is contacted by a needle or the like when the closure is penetrated, the provision of the annular member 58 protects the sterile state of the overall package.

A generally annular wall 60 whose circumference coincides with the circumference of the lid member 52 protrudes upward from the edge of the lid member 52. The annular wall 60 is formed with a number of openings 62 (four in the illustrated embodiment), and thus may be considered as four separate arcuate walls. The purpose of the opening 62 is to drain the liquid on the top of the lid member 52. Packages of sterile liquid are often autoclaved to ensure sterile conditions and there is a possibility that steam from the autoclave will condense on the package during the cold state. If the annular wall 60 does not have an opening 62, the annular wall will form a cup in which condensed water is maintained. Therefore, it is necessary to turn over the package or rely on evaporation to remove the water later. Forming annular wall 60 with opening 62 allows water to be simply drained. In a non-flat manner, for example, the member 52 may be formed such that the central portion of the member protrudes over the periphery region to help drain water.

A weak line 64 is formed around the region 66 on the upper surface of the lid member 52. The fragile line facilitates removal of region 66. Removal of this region 66 exposes the top surface of the stopper 40 which can later be penetrated by a hypodermic syringe needle or the like.

To allow area 66 to be removed, pull ring 68 is extended by legs 70 extending from area 66 of lid member 52 adjacent to weak line 64 to one side of pull ring 68. Attached. The legs, the pull ring and the annular wall are arranged such that the top surface of the pull ring 68 is below the top surface of the annular wall 60. This protects the pull ring 68 to prevent accidental manipulation and damage to its resulting seal.

The upper surface of the lid member 52 is provided with two upstanding members 72, 74 disposed on the radially opposite sides of the ring, one member 72 having a leg 70 attached to the pulling ring 68. Adjacent thereto and the other member 74 is opposed thereto. The upstanding members 72, 74 are dimensioned such that the top end is disposed directly below the pull ring 68. The upright member 74 maintains a portion of the pull ring 68 away from the leg in an upward spaced relationship from the lid member 52 to facilitate access when lifting the pull ring. The pull ring 68 and the protrusion 74 are integrally formed and are thus connected by bridging which is easily ruptured. The connection between the ring and the protrusion means that additional force must be applied to separate the ring and the protrusion before lifting the ring to open the container, and the need for this additional force reduces the chance of accidental opening. However, in other embodiments the connection may be omitted.

The upstanding member 72 close to the point where the leg 70 is attached to the pulling ring 68 serves as a pivot member for the pulling ring 68 to help remove the area 66. As shown by arrow 76 in Figure 4, when the free side of the ring (i.e., the side furthest from the point where the leg is attached) is lifted, the lower surface of the ring 68 is Contact with and pivot around the top surface. Since the ring 68 is pivoted about a point at the edge, the entirety of the ring 68 is lifted by the force applied by the user, and in particular the part of the ring to which the leg 70 is attached is covered by the cover member ( 52) is moved away from. Thus, the leg pulls over the area 66 of the lid member 52 adjacent the weak line 64 and tends to pull the area away from the rest of the cap 50. In addition, the lever action resulting from the use of the pivot increases the force applied to the lid member 52 by the legs 70 and assists in the removal of the region 66 of the lid member.

When the region 66 of the lid member 52 is removed, an opening in the lid member is formed that exposes the stopper 40. The edges of these openings and the torn portions are less sharp than similar edges formed from torn plastic material and formed from torn metal. Thus, the risk of the user being injured by the edges and the risk of infection associated with such a wound is significantly reduced.

Package 10 may be opened in a different manner. First, a pull ring 68 may be used to remove the region 66 of the lid member 52 adjacent the weak line 64 by lifting the ring 68 as described above. This exposes a portion of the surface of the stopper 40 which can later be penetrated by a hypodermic syringe needle or injection spike or the like to access the contents of the package 10. Once the contents have been sufficiently removed, the entire package (including bottle 20, cap 40 and the rest of cap 50) can be discarded. Since the entire package is formed of plastic material, there is no need to sort the various parts for recycling or waste disposal.

Second, the cap 50 can be removed by itself, then the stopper 40 is removed. This requires the removal of the detachable ring 56 from the bottom of the skirt 54 of the cap 50 which can later be unthreaded and discarded. The stopper is removed and this causes the contents of the bottle to be released or, for example, to insert a quill or straw of an autoinjector. In addition, if the contents of the package 10 are removed, the package may be discarded without sorting.

The container and cap parts of the package 10 are formed entirely of plastic material, which has many advantages over conventional packages. For example, plastic bottles are lighter and less prone to breakage than glass bottles. As a result, less space is required for the secondary packaging material and the predetermined number of packages without requiring deep care when loading the package. In addition, there is no need to sort the container and cap parts of the package before being processed. Because it is a torn plastic material, not a torn metal, it also reduces the risk of being injured from torn areas of the cap.

A cap for use in the second embodiment of the present invention is shown in Figs. The cap is generally similar to that used in the first embodiment of the package, with corresponding features indicated by corresponding reference numerals.

As in the first embodiment, the cap has a pull ring attached to the removable area. However, unlike the first embodiment, the pull ring is attached by a single leg 78. In addition, the upright members 72 and 74 were omitted. Since there is no upright member 72, the removable area must be removed without using the effect of levering as described above. However, it may be easier for a user to place a finger under the pull ring because there is no upright member 74 and there is no need to avoid the upright member or to first remove the ring from the upright member.

In addition, the weak line 64 is not formed on the upper surface of the lid member 52 as in the first embodiment, but is formed as a groove on the underside of the lid member 52 of the cap. This improves the appearance of the cap and may also improve the overall sterility of the package because there is no risk of contaminants being collected in the upward facing grooves. It should also be noted that the lid member of the cap is formed with a central area higher than the periphery to aid in draining the water. This is illustrated well in FIG. Another cap is shown in FIG. This cap is provided with a snap coupling portion 80 to engage the injector.

Claims (11)

A container 20 having a spout, a stopper 40 removably inserted into the spout, and a cap 50 overlaid on the stopper, the cap being removable for access to the stopper; A package (10) comprising a 66 and a releasable member (68) actuated by a user to remove the removable portion, The wall (60) extends around the periphery of the joinable member to protect the joinable member from accidental actuation or entanglement, the wall having at least one through opening (62). The package (10) of claim 1, wherein the container (20) and the cap (50) are formed of a plastic material. The package (10) of claim 1 or 2, wherein the engageable member comprises a ring spaced upwardly from the removable portion. The package (10) of claim 1, wherein the cap (50) comprises at least one protrusion (72) that acts as a pivot relative to the engageable member (68). 2. The package (10) of claim 1, wherein the cap (50) has a member (58) that engages the closure when the package is closed to protect the confined area of the closure from contamination. The package (10) according to claim 1, wherein the spout has an inner diameter and the container (20) has an area (32) below the spout having an inner diameter smaller than the inner diameter of the spout. The package (10) according to claim 1, wherein the cap (50) has an opening confirmation member (57) removably attached to the cap. The package (10) according to claim 1, wherein the opening confirmation member (57) is a ring that engages under the lip (30) of the container (20). delete delete delete