JP4754070B2 - 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

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to packages, and more particularly to packages for sterile liquids.
[0002]
[Prior art and problems to be solved by the invention]
In the medical field, sterile fluids such as drugs, formulations, sterile saline, etc. are often required for patient treatment. Such sterile liquids are supplied in bottles made of glass that are chemically inert and very unlikely to contaminate or otherwise degrade the sterile liquid.
[0003]
Glass bottles are usually closed with a rubber stopper member inserted into the mouth of the bottle. The stopper member is designed to be pierced with a hypodermic needle, an infusion spike of an infusion set, or the like, and the contents of the bottle can be extracted. Moreover, this stopper member can also be removed so that the contents of the bottle can be poured out.
In order to hold the plug member in place, a cap made of aluminum or similar thin sheet metal is crimped on the plug member and the top of the bottle. In order to pierce the plug member or to remove the plug member, the cap is partially or totally torn so that the plug member can be accessed.
[0004]
Such packages are widely used, but have a number of drawbacks. For example, glass bottles tend to be relatively heavy. Furthermore, glass is a relatively brittle material and glass bottles are prone to breakage. This is especially true when the bottle volume exceeds 100 ml. In order to reduce breakage during transport, such glass bottles must be carefully packed with inserts that separate them from each other. Since such inserts occupy a significant volume, the number of bottles that can be accommodated in a given volume is reduced, thus increasing the cost of carrying the bottles.
[0005]
Also, tearing off the aluminum cap can cause problems because sharp edges remain where the cap is torn. These edges are sharp enough to puncture surgical gloves or human skin, which is particularly disadvantageous in the medical field where the risk of infection needs to be kept to a minimum.
Also, in many European countries, waste must be sorted by type before disposal. The fact that the glass bottle has a metal cap and a rubber stopper means that this package contains three different types of materials (glass, metal and plastic) that need to be disposed of separately.
[0006]
Alternative approaches to sterile liquid containers have also been attempted, but their success has fluctuated. In one known product, a plastic bottle with a screw cap is used, the screw cap having a plug member attached thereto. When the screw cap is removed, the stopper member is also removed from the bottle. This avoids the problems associated with the use of glass bottles, but this package is incompatible with the infusion procedure and cannot be used with hypodermic needles like standard packages.
[0007]
In another proposal described in DE 19500460, a plastic bottle is provided with an injection-molded cap covered with plastic foil. In this proposal, there is no stopper at the mouth of the bottle, and the main seal of the bottle is made by an integrally formed closure wall that can be pierced with a cannula or spike but cannot be opened by other means. Yes. This cap is fitted to the closure wall. If access to the bottle contents is desired, the plastic foil must be removed and both the cap and closure wall must be pierced and sufficient force to penetrate both parts. Also, the cannula or spike can be clogged with closure wall material, or the material can flake off and produce particles in the bottle contents.
[0008]
It is also known to use a plastic bottle having a conventional stopper member held by an aluminum cap. These packages also have the problem that different parts of the package need to be separated prior to disposal as waste, and that sharp edges remain when the aluminum cap is torn.
A further type of closure manufactured by Stelmi, France, is marketed under the names "Monobloc" and "Duobloc". "Monobloc" has a plastic cap that fits over the neck and stopper of a conventional glass bottle. The tear-off portion allows access to the plug member and the entire cap can be removed if necessary. "Duobloc" is similar but has a threaded insert that snaps onto the neck of the glass bottle, and the rest of the cap is threaded into and engages the insert. However, in all cases, glass bottles with associated problems are used, and the various parts of the package must be separated prior to disposal of the package.
[0009]
[Means for Solving the Problems]
According to a first aspect of the present invention, there is provided a package comprising a container having a mouth portion, a stopper member inserted into the mouth portion, and a cap positioned on the stopper member,
A package is provided in which the container and the cap are formed from a plastic material.
[0010]
By forming the package container and cap from a plastic material, the weight and damage problems associated with glass containers are avoided. Further, it is not necessary to separate the package container and cap portion into glass, metal, and plastic prior to discarding the package.
The plug member is generally formed of an elastic material, and is preferably formed of plastic. The plug member can also be formed from rubber.
[0011]
In one preferred embodiment, the container is a bottle. This is preferable because the sterilizing liquid is routinely supplied in glass bottles, and even if the package is made of different materials, end user side by supplying the material in almost the same form. Desirable to avoid confusion.
Preferably, the container and cap have complementary shaped threads. This provides a simple and effective means for securing the cap to the container.
[0012]
In addition, it is preferable to provide a feature that reveals that the cap has been opened to reduce the risk of liquid being dispensed from a package that has been opened and then closed again. Opening and reclosing in this manner may result in the liquid losing its sterility or the liquid being somehow degraded or contaminated. One preferred form of the feature that reveals the opening is a member that is detachably attached to the cap, which must be separated from the cap before the cap can be removed. Thus, the absence of this member is an indication that the package has been opened at some time and should not be used.
[0013]
In a preferred embodiment, the cap includes a removable portion that can be removed to access the plug member.
With such a cap, the closure can be opened by many means. The removable portion can be removed to allow access to the plug member, while the plug member is left in place and retained. The plug member can then be pierced with a hypodermic needle or the like. Alternatively, the entire cap can be removed (this entails removal, which is a feature that reveals that it has been opened), thus allowing access to the entire plug member. This may be useful, for example, when trying to use an infusion spike that is wider than the removable part. Another variation is that the entire cap and plug member can be removed, allowing pouring, or inserting a needle or straw to allow filling into an automatic syringe.
[0014]
Preferably, the cap has an engageable member for removal of the removable portion by manipulation by the user. This facilitates removal of the removable part.
In a preferred arrangement, the engageable member comprises a ring spaced upward from the removable portion. As a result, the user of the package can operate more easily by placing a finger under the engageable member.
[0015]
Further, the cap preferably has at least one protrusion that acts as a pivot relative to the engageable member. Without the pivot, the force applied to the engageable member by the user is simply transmitted to the removable portion. However, when a pivot point is provided, the leverage effect amplifies the force applied to the engageable member, which makes it easier to remove the removable portion.
[0016]
In a preferred embodiment, the engageable member protrudes from the cap, so that there is a risk that the engageable member may get caught on something and accidentally manipulated to remove the removable site. Accordingly, it is preferable to provide the cap with a wall portion that extends entirely at the periphery of the engageable member to protect it from accidental manipulation or, for example, entanglement with other packages. As a result, the engageable member is “enclosed” and there is less opportunity for the member to be accidentally manipulated. If the engageable member is a pull ring, such a pull ring is advantageously protected on its entire periphery.
[0017]
Furthermore, it is preferable that a wall part has at least 1 opening which penetrates the wall part. The majority of sterile liquid packages for medical applications are sterilized by autoclaving in a steam atmosphere, and when the atmosphere in the autoclave cools, steam may condense on the package into water. If the walls are continuous, the walls form a cup where water is collected. By providing an opening in the wall, water can escape.
[0018]
The cap is preferably provided with a member that engages the plug member when the package is closed to protect a specific area of the plug member from contamination. Advantageously, the engaging member is an annular member extending downward from the cap and engaging the upper surface of the plug member. Thus, the annular member provides a physical barrier to contaminants and functions to keep a particular area sterile. The integrity of the seal created by the annular member is preferably achieved by a member that elastically deforms the portion of the plug member with which the annular member engages.
[0019]
The idea of providing a wall to protect the engageable member from accidental actuation is considered a unique inventive value. Therefore, according to the second aspect of the present invention, there is provided a package comprising a container having a mouth portion, a plug member removably inserted into the mouth portion, and a cap positioned on the plug member. And
A removable portion that can be removed so that the cap can access the plug member; an engageable member for removal of the removable portion by a user operation; and A package is provided comprising a wall that extends generally at the periphery and protects the member from accidental manipulation or entanglement.
[0020]
Furthermore, the wall portion preferably has at least one opening penetrating the wall portion for the reason described above.
In another preferred embodiment, the mouth has a predetermined inner diameter and the container has a region below the mouth having an inner diameter smaller than the inner diameter of the mouth. The diameter-reduced portion (throttle portion) formed in this way protects the plug member from being pushed into the container when a force is applied to the plug member with, for example, a hypodermic syringe. ing. When the plug member is pushed down, it comes into contact with the reduced diameter portion, thereby preventing the plug member from moving further downward.
[0021]
The idea of providing such a reduced diameter part is considered to be a unique inventive value. Therefore, according to the third aspect of the present invention, a package including a container having a mouth portion for accommodating a plug member,
The mouth portion has a predetermined inner diameter, and the container has an area below the mouth portion having an inner diameter smaller than the inner diameter of the mouth portion, whereby the plug member is connected to the mouth portion. The package is provided that is configured to prevent movement from a portion into the region.
[0022]
DETAILED DESCRIPTION OF THE INVENTION
Preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings.
FIG. 1 shows a package 10 according to a first embodiment of the present invention. The package 10 includes a plastic bottle 20, a stopper member 40, and a plastic closure cap 50. The plug member is preferably formed from a thermoplastic polymer. It may be formed from other synthetic polymer materials, or synthetic rubber (such as chlorobutyl rubber) or natural rubber.
[0023]
The bottle 20 has a body portion (body) 22, a shoulder portion 24, and a neck portion 26 that extends from the shoulder portion and narrows. The external surface of the neck has external threads 28 formed on the external surface. The lip 30 projects radially outward (outward in the radial direction) from the neck 26 below the external thread 28.
The inner surface of the neck is substantially cylindrical. However, the inner surface also has a reduced diameter portion 32. The reduced diameter portion is for preventing the plug member 40 from being pushed into the neck portion 26 when a force is applied to the plug member with a hypodermic needle or the like, for example. The reduced diameter portion may have a slightly smaller diameter than the rest of the neck, as shown in FIG. 1, or the diameter of this portion may be as shown in FIGS. It may be substantially smaller than the rest of the neck.
[0024]
The stopper member 40 has a generally cylindrical main body 42, and the radius of the main body is slightly smaller than the radius of the inner surface of the bottle neck. Thereby, the main body portion 42 of the stopper member 40 can be fitted to the neck portion 26 of the bottle. Therefore, the bottle can be sealed by the stopper member. A chamfered portion 44 for facilitating insertion of the main body 42 is formed in the neck 26 of the bottle 20 at the lower end of the main body 42.
[0025]
A flange 46 is formed at the upper end of the main body 42. The flange 46 abuts the top of the bottle neck when the stopper member 40 is completely inserted into the bottle neck.
Further, a hollow portion 48 is formed in the inside of the lower surface of the plug member 40. The hollow portion 48 extends upward from the lower surface of the plug member 40 toward the top, and as a result, the thickness of the central portion of the plug member 40 is considerably smaller than the length of the plug member. As a result, the stopper member can be easily pierced with a hypodermic needle, an infusion spike, or the like.
[0026]
The closure cap 50 is attached to the top of the neck 26 of the bottle. The cap has a cover member 52 located on the plug member 40 and an annular skirt 54 extending downward from the edge of the cover member 52.
The skirt 54 has an internal thread 56 formed on its internal surface. This internal thread 56 engages with an external thread 28 formed on the neck 26 of the bottle so that the closure is held in place.
[0027]
A ring 57 is detachably attached to the lower end of the skirt 54. The ring 57 engages the lower portion of the lip 30 on the neck 26 of the bottle. Therefore, the separable ring 57 functions as a member indicating that it has been opened. In order to remove the cap 50 from the bottle 20, it is necessary to first separate the ring 57 from the cap 50. And it becomes clear to a user that the package 10 was opened by this separated ring.
[0028]
An annular member 58 extending downward from the cover member is formed on the lower side of the cover member 52. The lower end of the annular member is engaged with the upper surface of the plug member 40 so that the package 10 is integrated. The annular member 58 surrounds the central portion of the upper surface of the stopper member, so that the upper surface of the stopper member is not contaminated. Since the central portion of the upper surface of the plug member is a portion where a needle or the like comes into contact when a hole is made in the plug member, the provision of the annular member 58 ensures the sterility of the entire package.
[0029]
A substantially annular wall 60 projects upward from the edge of the cover member 52, and the peripheral shape of the wall 60 matches the peripheral shape of the cover member 52. A plurality of openings 62 (four in the illustrated embodiment) are formed in the annular wall portion 60. Accordingly, the annular wall portion 60 can be considered as four separated arc-shaped wall portions. Through this opening 62, the liquid accumulated on the upper surface of the cover member 52 can be discharged. Sterile liquid packages are often autoclaved to ensure sterility, and it is very likely that steam from the autoclave will condense on the package during the cooling phase. When the annular wall portion 60 does not have the opening 62, the annular wall portion forms a cup, and condensed water accumulates therein. In that case, it may be necessary to invert the package to remove the water or wait for the water to evaporate. By forming the opening 62 in the annular wall portion 60, such water can be easily discharged. For example, by discharging the central portion of the cover member 52 upward from the peripheral portion thereof, the discharge of such water can be assisted by not making the cover member 52 flat.
[0030]
A fragile line 64 is formed around the portion 66 on the upper surface of the cover member 52. The portion 66 can be removed by this weak line. By removing this portion 66, the upper surface of the plug member 40 is exposed, and this exposed portion can be pierced with a hypodermic needle or the like.
[0031]
In order to be able to remove the part 66, a pull ring 68 is attached to the part 66 via a leg 70. The leg 70 extends from the portion 66 of the cover member 52 joined by the weak line 64 to one side of the pull ring 68. The leg portion, the pull ring, and the annular wall portion are arranged so that the upper surface of the pull ring 68 is positioned below the surface of the annular wall portion 60 having the highest height. With this configuration, the pull ring 68 is protected, and the pull ring is prevented from being accidentally operated, and the accidental operation prevents the closure from being damaged.
[0032]
Further, on the upper surface of the cover member 52, two rising members 72 and 74 disposed on the opposite side in the diameter direction of the ring are provided. One (72) is adjacent to where the leg 70 is attached to the pull ring 68 and the other (74) is on the opposite side. The rising members 72, 74 are sized such that their tallest ends are located directly below the pull ring 68. By this rising member 74, the pull ring 68 is held in a state of being spaced apart from the leg portion with a space upward from the cover member 52. Thus, when the pull ring 68 is to be lifted, the pull ring can be easily accessed.
[0033]
The pull ring 68 and the protrusion 74 are integrally formed and are connected by a brittle bridge. The fact that the ring and protrusion are joined means that before the ring can be lifted and the container can be opened, extra force must be applied to separate them. By requiring such extra force, the chance of accidental opening of the container is reduced. However, such coupling can be omitted as in other embodiments.
[0034]
A rising member 72 located near the point where the leg 70 is attached to the pull ring 68 functions as a pivot member for the pull ring 68 to facilitate removal of the site 66. When the free side of this pull ring (i.e., the side farthest from where the legs are attached) is lifted as indicated by the arrows in FIG. It abuts on the surface and rotates around this abutment (pivot action). The pull ring 68 pivots about its edge points so that the entire ring 68 is lifted by the force applied by the user to the ring 68. In particular, the portion of the ring to which the leg 70 is attached moves away from the cover member 52. As a result, the leg portion is pulled by the portion 66 of the cover member 52 joined by the fragile line 64, and the portion 66 is easily pulled away from the remaining portion of the cap 50. Furthermore, the lever is acted by this rotation, and the force applied to the cover member 52 via the leg portion 70 increases, so that the portion 66 of the cover member can be easily removed.
[0035]
By removing the portion 66 of the cover member 52, an opening is formed in the cover member, and the plug member 40 is exposed. The edge of the opening, and the edge of the torn portion, is formed from a torn plastic material and is much less sharp than a similar edge formed from a torn metal. Therefore, the risk of the user himself being cut at the edge and the risk of infection associated with such a cut is significantly reduced.
[0036]
The package 10 can be opened by various means. First, as described above, by using the pull ring 68 to lift and pull the ring 68, the portion 66 of the cover member 52 joined by the weak line 64 can be removed. As a result, the surface portion of the plug member 40 is exposed, and this portion can then be pierced with a hypodermic needle or a drip spike to access the package contents. Once a sufficient amount of content has been removed, the entire package (consisting of the bottle 20, the plug member 40, and the remainder of the cap 50) can be discarded. Since the entire package is formed from a plastic material, it does not need to be separated into various parts for recycling or waste disposal.
[0037]
Second, the cap 50 itself can be removed and then the plug member 40 can be removed. This requires removing the separable ring 56 from the bottom of the skirt 54 of the cap 50, which can then be unscrewed to remove the cap and discard it. When the stopper member is removed, the contents of the bottle can be poured out or, for example, an auto-injector needle or straw can be inserted. Also in this case, after the contents of the package 10 are once taken out, the package can be discarded without being separated.
[0038]
Because the container and cap portions of the package 10 are all made of plastic material, the package 10 has many advantages over conventional packages. For example, plastic bottles are not only lighter than the corresponding glass bottles but also less prone to breakage. As a result, less care needs to be taken when transporting the package. Thus, for a given number of packages, less secondary packaging material is required and less space is required. Also, there is no need to separate the container and cap portions of the package prior to disposal. Also, since the torn parts of the cap are not the torn metal but the torn plastic material, there is less chance of being damaged by these torn parts.
[0039]
A cap for use in the second embodiment of the invention is shown in FIGS. This cap is generally similar to the cap used in the cap of the first embodiment, and corresponding major parts are indicated by corresponding reference numerals.
As in the first embodiment, the cap has a pull ring attached to the site where it can be removed. However, in contrast to the first embodiment, the pull ring is attached by a single leg 78. Further, the rising members 72 and 74 are omitted. Since the rising member 72 does not exist, the portion that can be removed must be removed without using the lever effect as described above. However, since the rising member 74 is not present, it is easier for the user to put his finger under the pull ring. This is because it is not necessary to avoid the rising member or to break the ring from the rising member.
[0040]
Further, the weak line 64 is not formed on the upper surface of the cover member 52 as in the first embodiment, but is formed as a groove below the cover member 52 of the cap. This improves the appearance of the cap and eliminates the detrimental effect that contaminants accumulate in the upward facing grooves, thereby improving the overall sterility of the package. It should also be noted that the cover member of the cap is formed with a central portion that is higher than the periphery of the cover member, and assists in draining water. This is best shown in FIG.
[0041]
An alternative embodiment of these caps is shown in FIG. The cap is provided with a snap fit 80 that can be engaged by a syringe.
[Brief description of the drawings]
FIG. 1 is a partially broken side view of a package according to a first embodiment of the present invention.
FIG. 2 is a cross-sectional view of a plug member.
3 is a cross-sectional view taken along line III-III in FIG.
4 is a cross-sectional view taken along line IV-IV in FIG. 1. FIG.
FIG. 5 is a cross-sectional view of a cap for use in the package of the second embodiment of the present invention.
FIG. 6 is a plan view of the cap of FIG.
FIG. 7 is a cross-sectional view taken along line VII-VII in FIG.
FIG. 8 is a side view of an alternative cap.
FIG. 9 is a cross-sectional view of an alternative bottle.
FIG. 10 is an enlarged view of a part of FIG. 9;

Claims (7)

A package (10) comprising a container (20) having a mouth portion, a plug member (40) removably inserted into the mouth portion, and a cap (50) positioned on the plug member. ,
A removable portion (66) wherein the cap (50) can be removed to allow access to the plug member; and an engageable member (68) for removing the removable portion upon user manipulation. A wall (60) extending generally around the periphery of the engageable member to protect the member from accidental manipulation or entanglement; and a cover member (52) positioned over the plug member (40) And the cap (50) has at least one protrusion (72) that acts as a pivot for the engageable member (68), and the wall (60) The package (10) has at least one opening (62) penetrating the wall portion, the cover member (52) is not flat, and the central portion projects upward from the peripheral edge portion. .   The package (10) of claim 1, wherein the container (20) and cap (50) are formed of a plastic material.   The package (10) of claim 1 or claim 2, wherein the engageable member (68) comprises a ring spaced upwardly from the removable portion (66). The cap (50) is provided with a member (58) that engages the plug member when the package is closed to protect a particular area of the plug member from contamination. Package (10) according to any one of claims 3 to 3 . The mouth portion having a predetermined inside diameter, said containers (20), a region (32) having an inner diameter smaller than the inner diameter of the mouth portion, having below the mouth portion, claims 1 to 4 The package (10) according to any one of the above. 6. A member according to any of claims 1 to 5 , wherein a member (57) is provided to clarify that the cap (50) has been opened, and the member (57) is detachably attached to the cap. The package (10) of paragraph 1. The package (10) according to claim 6 , wherein the unfolding member (57) is a ring that engages a lower portion of the lip (30) of the container (20).

Images