JP4288742B2 - Reusable universal stopper - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an elastic stopper having an automatic sealing means such that a medicine contained in a container closed by the elastic stopper can be repeatedly inserted by using a luer connector or a syringe having a blunt or sharp needle cannula. About.
[0002]
[Prior art]
Prior art has developed a number of devices to prevent accidental needles and wounds on practitioners and patients. Such damage is known to spread infections including hepatitis and AIDS. One of the main features of these devices is the lack of a bare sharp needle. The lid or stopper incorporated a means for insertion into the contents of the container, such as drug bottles, cartridges and bottles. The lids or plugs in these devices serve the dual function of sealing the container while allowing insertion through it.
[0003]
Vessel stopper systems such as drug bottles and bottles are made from chemical and pharmaceutical resistant materials such as corrosive substances, reagents, parenteral solutions and solid formulations that can be reconstituted with solvents prior to use. It has been. The most commonly used stopper / container systems for such products were glass or plastic bottles and vials with stoppers made of elastomeric material. This system provides easy insertion through the elastic stopper by use of an infusion spike or syringe when a good hermetic seal to the contents, safe storage and withdrawal of the contents is desired. Commonly used elastic plugs consist of an elastomeric body such as natural or synthetic rubber and an inert coating covering at least some portion of the plug. The coatings used include chlorobutyl rubber, fluorocarbon polymer resins such as polytetrafluoroethylene and various thermoplastic films. The coating is intended to insulate the elastic stopper body from the contents of the container to prevent contact between them and possible chemical reactions.
[0004]
Generally, the elastic stopper is cylindrical and has a flange head that lies over the open end of the container. The whole with the head extends into the open end and is the body part located at the neck of the container. The diameter of the body part is larger than the inner diameter of the container so that a tight seal can be made between the body part and the container wall. Is too large. The lower end of the main body portion is inclined toward the center of the main body portion and the vertical axis in order to facilitate the insertion of the main body portion into the container. The circular bottom facing the contents of the container is substantially flat and has no holes and no recesses therein. The head of the plug includes a central recess that extends downwardly substantially away from the top of the body portion such that a central recess and a circular bottom define the diaphragm. The wall forming the recess is generally cylindrical but may include one or more circular protrusions extending inwardly ending near the centerline of the plug. The circular protrusion serves to push and hold the syringe needle when the needle is inserted through the recess to penetrate the septum for removal of the contents of the container. The elastic stopper is usually held in place by a metal ring or cap made of aluminum. The metal ring or cap has a central opening that can be removed to allow insertion of the injection needle into the container.
[0005]
Various stoppers and insertion systems exist in the prior art for holding and removing the contents of the container illustrated below.
[0006]
An example of a state-of-the-art plug is reported in FIGS. 6A and 6B herein.
[0007]
U.S. Pat. 5,429,256 relates to a medicine withdrawal system for medicine bottles. This drawer system consists of: a medicine bottle containing the drug in it and closed with a rubber gasket; and a device that fits snugly on top of the medicine bottle. The device consists of a chassis and a cap attached to the cap by a movable hinge. The chassis is cylindrical and has a vertical groove on the outside for easy handling. The top of the chassis has a central opening. The chassis includes a removable male luer securing adapter that includes a base structure that is threaded on the outside and whose lower end has a hollow sharp lancet. The device is used with a syringe having a female luer locking connector that fits a removable male luer locking adapter containing a base. In use, the cap cover is opened and the syringe is screwed onto the outer end of the adapter where it is clamped to the adapter that moves the lancet downward thereby establishing a flow path with the contents of the vial.
[0008]
U.S. Pat. 5,433,330 relates to a needleless insertion plug for use with a cannulated container having a blunt plug penetrating tip. The stopper includes a disk and a plug extending from the disk into the container. Also included is a diaphragm defined by a target area on the top surface. This plug is not suitable for intravenous tubing having a syringe, cartridge or female luer connector. In addition, a pre-cut disc after use does not guarantee a complete seal of the contents of the container from the surrounding environment and is not useful for repeated use.
[0009]
[Problems to be solved by the invention]
In this technical field, which provides a repetitive use stopper system, it is possible to repeatedly insert a medicinal solution contained in a container, and at the same time, an intravenous tube or a sharp or blunt needle cannula or a sharp or blunt spike fitted with a cartridge or female luer connector. There is a need to provide an insertion means that allows the insertion of various conventional external insertion means, such as syringes, having a container into the container.
[0010]
[Means for Solving the Problems]
The present invention is intended for health professionals and emergency practitioners and sometimes patients who require self-injection with intravenous tubing or a sharp or blunt needle cannula or sharp or blunt spike fitted with a cartridge or female luer connector. A versatile universal lid assembly is provided that allows repeated insertion of a drug solution contained in a container with a variety of conventional external insertion means available, such as a syringe.
[0011]
According to one aspect, the present invention is intended for repeated use that allows insertion into a chemical contained in a container that includes insertion (acceptance) and sealing means designed for repeated use so that the chemical can be repeatedly inserted. A universal lid assembly is provided. Each time the desired amount of drug solution is withdrawn, the sealing means then automatically seals itself, thereby preventing contamination of the drug solution by airborne particulates such as dust and bacteria.
[0012]
More particularly, the reusable universal lid assembly according to the present invention comprises: an elastic stopper comprising sealing means and receiving means for external insertion means.
[0013]
The elastic plug according to the present invention having a head and a skirt is made on the basis of an elastic body such as natural or synthetic rubber, and preferably covers at least the portion of the plug that contacts the chemical solution. Has an inert polymer coating. The coating may be chlorobutyl rubber, fluorocarbon polymer resin and thermoplastic film.
[0014]
The elastic stopper is cylindrical and has a flange head that covers the open top end of the container. The skirt, which extends into the open end and is located at the neck of the container, is integral with the head, and the diameter of the skirt is adjusted so that a tight seal is created between the skirt and the container wall. It is somewhat larger than the inner diameter.
[0015]
The central portion of the elastic plug has a cylindrical opening that extends through the head and skirt of the plug. A cylindrical opening through the closure will expose the contents of the container to the environment from which contamination is possible. According to the invention, the cylindrical opening is closed by a sealing means, i.e. a tearable sealing membrane. The breakable sealing membrane may be made separately from the elastic plug, placed in the opening and sealed into the elastic plug using thermoplastic or other sealing means known in the art. If possible, the elastic plug and sealing membrane are both integral and may be manufactured by blow molding or other suitable manufacturing technique. The sealing membrane is preferably a protrusion inherent in the upper half of the head of the elastic plug and has a vertical leg or cylindrical side wall; and a cup or U-shape extending down toward the bottom of the elastic plug Is similar to the M-shape formed from the top surface making up the M-shape when considered together with the cylindrical sidewall. The breakable sealing membrane is made of a thin elastomeric material and preferably has a tear that does not completely traverse its central portion.
[0016]
The M-shaped sealing membrane in the elastic stopper will collapse or at least deform when pierced by a luer connector, a sharp or blunt injection cannula. In order to prevent such a situation, a rigid cylindrical housing or male member with open ends is provided to support the M-shaped sealing membrane and also serve as a receiving means for external insertion means. Such external insertion means is preferably female insertion means such as a female luer connector. Such external insertion means is screwed into the male coupling means, thereby breaking the sealing membrane to establish a fluid passage with the contents of the container.
[0017]
The multi-use universal lid assembly further comprises a cylindrical collar and yet a removable cap.
[0018]
A cylindrical collar, preferably made of metal such as aluminum, is secured over the elastic stopper and the neck of the container to hold the elastic stopper firmly at the open end of the container. The cylindrical collar includes a cylindrical opening on the flat top and a central opening that allows insertion into the sealing membrane and receiving means (male member) installed in the cylindrical opening.
[0019]
The removable cap includes a retaining ear that covers the flat top and edges of the cylindrical collar and engages the cylindrical collar to maintain the lid assembly in a sterile condition.
[0020]
According to another aspect, the present invention provides a multi-use universal lid assembly / container combination comprising: a container; and a multi-use universal lid assembly according to the present invention.
[0021]
According to yet another aspect, the present invention provides a method for repeatedly inserting into a drug solution contained in a container equipped with a multi-use universal lid assembly of the present invention comprising the following steps:
i) providing a multi-use universal lid assembly / container combination of the present invention;
ii) removing the removable cap from the flat top and edge of the cylindrical collar, thereby exposing the sealing means and receiving means within the cylindrical opening of the elastic stopper; and
iii) Insert the external insertion means into the chemical solution contained in the container.
[0022]
The present invention provides sealing and insertion means for containers such as glass or plastic bottles or drug bottles containing drug solutions such as X-ray contrast agents and parenteral liquids. The insertion means of the lid assembly of the present invention provides what is required for hermetic sealing, safe handling, sterilization and storage. The sealing means is designed for repeated use so that the medicinal solution can be repeatedly inserted. Each time the desired amount of drug solution is withdrawn, the sealing means then automatically seals itself, thereby preventing contamination of the drug solution by airborne particulates such as dust and bacteria. For simplicity, the invention will be described in combination with a glass vial. However, it should be understood that the present invention generally comprises a rigid or semi-rigid insertion port and includes sealing and receiving (insertion) means for containers capable of receiving such sealing and insertion means.
[0023]
The container is preferably made of glass, but can also be made of polymeric materials known in the art. The container has a neck that terminates in an open end that houses a lid assembly that is inserted into the open end to seal the contents therein and maintain it aseptically and preservatively.
[0024]
Although the present invention provides for insertion into medicinal solutions using various external insertion means, the insertion means is “sharp” like a sharp needle cannula to prevent transmission of infectious diseases such as accidental injury and AIDS. Is not preferred.
[0025]
The external insertion means is preferably a syringe, a cartridge or a venous tubing having a female luer connector. However, other insertion means such as a syringe having a sharp or blunt needle cannula or spike may be used to break the sealing membrane of the lid assembly.
[0026]
DETAILED DESCRIPTION OF THE INVENTION
Referring to FIGS. 1A, 1B, 2, 3, 4A and 4B, the container 10 has an open end such that the reusable universal stopper used comprises a neck 12, a side 14, and a bottom 16. The open end of the neck 12 is securely held in place by a cylindrical collar 70 having an open area 71 in the center of its top, the open area being a circular edge represented by the numeral 74 A multipurpose stopper for repeated use is installed. The cylindrical collar further comprises a flat top surface 75 and a top side 73 defined by circular edges 74 and 76. The cylindrical collar 70 is folded into the container neck 12 at its bottom edge 72. The flat top surface 75 is covered with a cylindrical removable cap 18 consisting of the flat top 20 and the side 22 overlying the top 73 of the cylindrical collar 70. FIG. 1B shows a fixed ear 50 constituting a part of a universal stopper described later with reference to other drawings as the description of the present invention proceeds.
[0027]
With reference to FIGS. 1A, 1B, 5A and 5B, the removable cap 18 has a cylindrical collar flat top surface 75 to keep the area 71 open at the center of the top of the cylindrical collar and the fixed ear 50 sterile during storage. And the top side 73 is covered. The removable cap 18 comprises: a side 22, a flexible holding ear 24, and a holding button 26. In place, the retaining ear 24 slides under the circular edge 74 of the cylindrical collar 70 and provides a tight seal between the removable cap 18 and the flat top surface 75 of the cylindrical collar. The retention button 26 along with the retention ear 24 also serves to limit the expansion of the thin elastic membrane or seal during sterilization.
[0028]
Referring to FIGS. 1A, 1B, 4A, 4B, 6A, 6B, 6C and 8, the open end of the container 10 has a top surface 63 and a bottom surface 65 and comprises a head 62 and a skirt 64 integral therewith. The elastic stopper 60 is accommodated. The head consists of a flange 66 extending laterally outward from the skirt 64 and is designed to cover the transverse end face of the container. The elastic stopper shown in FIGS. 6A and 6B is normally used according to the prior art. As best seen in FIGS. 4B and 8, the elastic plug in the present invention further includes: a cylindrical opening 68 in its center constrained by a cylindrical wall represented by numerals 80 and 80 '; numerals 82 and 82 And a funnel-shaped opening 83 extending downwardly into the container from the bottom ring defined by walls 84 and 84 '. Protruding upwardly toward the top surface 63 of the elastic plug 60 is a cylindrical, vertically oriented cylindrical projection 85 defined by the cylindrical walls 86 and 86 ′ and the top surface 120. Along with the cylindrical walls 86 and 86 ', the top surface 120 is designed to serve as an elastic seal in the elastic stopper. The cylindrical protrusion is preferably integral with the plug body, such as made by blow molding techniques, or it is made separately and sealed in a central opening defined by walls 80 and 80 'in the elastic plug 60. May be.
[0029]
The vertically oriented cylindrical protrusion is made of a thin film-like material designed to be broken by external forces exerted on the protrusion by an external insertion means such as a luer connector. As best seen in FIGS. 4C and 4D showing cross-sections and top views, the cylindrical protrusions represent the numbers 86 and 86 ′ representing the legs and the number 120 representing the top surface of the cup-like shape. M-shaped diaphragm. The lowest point of the top surface 120 is the center point of the cup-shaped part and is represented by the numeral 121. The lowest point 121 is provided with a crevice 122 that extends from the top or inner surface toward the bottom surface 125 of the cup-shaped portion of the M-shaped diaphragm. However, the fissure does not penetrate to the bottom surface 125. The thickness between the fissure 122 and the intact bottom surface 125 is typically about 0.001 to about 2.0 mm. The non-penetrated portion of the membrane representing its thickness at the central portion is represented by numerals 127 and 127 'in FIGS. 4C and 4D. Non-penetrating membranes keep the contents of the container sealed. In use, when the membrane is breached by external insertion means such as a needle cannula, luer connector or spike, a fluid passage is established between the contents of the container and the external insertion means. When the external insertion means is removed from the multi-use universal stopper, the cup-shaped portion of the diaphragm reseals itself because the membrane is elastic and bounces back to its original shape. As a result, the container is resealed until the chemical extraction process is repeated.
[0030]
Referring to FIGS. 7A, 7B and 8, a cylindrical housing or male member (accepting generally indicated at 100) is provided to support a vertically oriented cylindrical projection 85 and provide a means for receiving a male luer connector. Means) is provided at the upper center 68 of the elastic plug 60. The housing 100 comprises: a cylindrical wall 102 having a top surface 104 and a bottom surface 106. The cylindrical wall 102 comprises an inner wall 108, an outer wall 110, a fixed ear 50, and a horizontally oriented bottom 112. The fixed ear 50 is designed to hold the female member of the luer connector firmly. The horizontally oriented bottom 112 extends into the skirt 64 and is sealed there by the bottom ring portions 82 and 82 'of the elastic plug 60.
[0031]
The cylindrical projection serving as a sealing membrane is made of an inert gas impermeable polymeric material capable of flexing under internal and external pressures such as those applied during steam sterilization. Preferably, the membrane has a thickness of about 0.001 mm to about 2.00 mm and a Shore A hardness of about 25 to about 80. Suitable elastic materials to make up the membrane are:
Natural rubber;
Acrylic acid butadiene rubber;
Cis-polybutadiene;
Chlorobutyl rubber;
Chlorinated polyethylene elastomer;
Polyalkylene oxide polymers;
Ethylene vinyl acetate;
Fluorosilicone rubber;
Hexafluoropropylene-vinylidene fluorinated tetrafluoroethylene terpolymers, such as those marketed under the trade names Fluorol and Viton;
Butyl rubber;
Polyisobutene, as marketed under the trade name Vistanex;
Synthetic polyisoprene rubber;
silicone rubber;
Styrene butadiene rubber;
A tetrafluoroethylenepropylene copolymer; and
Thermoplastic copolyester.
[0032]
The cylindrical M-shaped projection is positioned within the elastic stopper 60 such that when the cap is placed over the container 10, its top surface 120 is about 2 to 3 mm away from the retaining button 26 of the cap 18 that can be removed. This spacing allows the membrane to deflect outward under pressure such as occurs under heat sterilization. However, this spacing should not be more than about 2-3 mm so that it can be prevented by the retaining button 26 of the cap 18 from being able to remove the membrane rupture when accidentally subjected to high pressure.
[0033]
The multi-use universal lid assembly of the present invention may have the shape shown in FIGS. This shaped stopper is used when it is desired to freeze-dry the contents of the container. Prior to use, the lyophilized contents are returned by injecting water, saline or other liquids through the multi-use universal stopper into the container.
[0034]
The universal lid assembly of the present invention should preferably be used with an external female luer connector when a fluid passageway to the contents of the container plugged by the universal stopper is desired. A typical female luer connector 140 is shown in FIG. 11 and comprises: a cylindrical outer wall 142 and a cylindrical inner wall 143 having an opening at its center for receiving tubing within the inner wall. A cylindrical ring 144 located in the center of the top of the cylindrical inner wall 143 holds the tube 160 with the fluid passage conduit 162 firmly. The cylindrical inner wall 143 further mates with a fixed ear 50 on the housing or male member 100 as shown in FIGS. 7A and 7B when connecting the female luer connector to the male luer connector. Thread 146, 148, 150 and 152. Other types of female luer connectors such as snap-on connectors can also be used.
[0035]
12A-C show a cross-sectional view of a syringe having a female luer connector that mates with a reusable universal stopper on the container 10, where the syringe and universal stopper are prior to mating. When it is desired to inject the drug solution from the container 10 to the patient, the removable cap 18 is removed by the upward hand force applied to the side 22 thereof, thereby exposing the fixed ear 50 of the insertion means housing. To.
[0036]
If the female luer connector of FIG. 11 is used, it is attached to the reusable universal lid assembly by a twisting motion in which the threads 146, 148, 150 and 152 engage the stationary ear 50 of the insertion means housing 100. . By turning the female luer connector 140, the end of the tubing 160 breaks the universal stopper membrane to establish a fluid pathway with the contents of the container.
[0037]
FIG. 12B shows a cross-sectional view of a syringe having a female luer connector partially mated with a reusable universal lid assembly.
[0038]
FIG. 12C shows a cross-sectional view of a syringe having a female luer connector fully mated with a reusable universal lid assembly.
[0039]
FIG. 13 shows a cross-sectional view of a syringe having a female luer connector removed from the multi-use universal lid assembly after mating.
[0040]
The multi-use universal lid assembly can be mated with an external female luer connector that has a blunt end that mates and breaks the cylindrical M-shaped seal in the center of the multi-use universal lid assembly. However, the reusable universal stopper allows insertion into the container contents with a sharp or blunt needle cannula or spike.
Constituent materials and usage
The elastic stopper used with the universal stopper of the present invention has no leachable additives in it to prevent any alteration of the product contained in the container, is impervious to fluids, elastic and inert It is. It is a single component or a mixture of components. Examples of materials include synthetic and natural rubbers such as butyl rubber, isoprene rubber, silicone rubber, halogenated rubber, ethylene propylene terpolymer and the like. Detailed examples of synthetic elastomer rubber are CH₂CF₂-C_ThreeF₆(C_ThreeF_FiveH) and C₂F_Four-C₂F_ThreeOCF_ThreeA series of elastomers; fluorosilicone rubbers such as Dow Corning under the trade name Silastic®; and polyisobutylenes such as Vistanex MML-100 and MML-140; and chlorobutyl 1066 from Exxon Chemical Includes halogenated butyl rubber.
[0041]
These or other elastomers are made into the desired plug shape by known methods. Such methods usually involve the use of curing agents, stabilizers and fillers and consist of primary and secondary curing steps at elevated temperatures.
[0042]
The containers used in connection with the present invention are made of glass or polymeric material, ie plastics well known in the pharmaceutical industry. If the container is made of glass, it is in the form of a medicine bottle or bottle. The vial or bottle is made of a rigid or semi-flexible polymeric material. In all forms, the container is provided with a neck that is rigid and retains the form that is capable of being hermetically sealed by the elastic universal stopper of the present invention. The container has a capacity of 5 ml to 1000 ml or more preferably about 10 ml to 500 ml.
[0043]
The container mouth contains a multi-use universal lid assembly. The outer diameter of the stopper is slightly larger than the inner diameter of the neck of the container so that a tight seal is achieved in repeated insertion of the universal stopper into the mouth of the container.
[0044]
The cylindrical collar is preferably made of a metal such as aluminum, while the housing is made of hard plastic known in the prior art and is used with chemicals.
[0045]
Prior to use, the container and lid components are sterilized and the container is filled with a drug solution, such as a parenteral solution. The repeated use universal stopper is inserted while sealing the contents of the container. A cylindrical collar is then pushed over the container to securely hold the universal lid assembly for repeated use. Finally, a removable cap snaps onto the cylindrical collar to complete container closure.
[Brief description of the drawings]
FIG. 1A is a perspective view of a container, a cap with repeated use receiving (insertion) means and a cap covering the insertion means; B is an uncapded container shown in FIG. 1A and with repeated use receiving means The perspective view of a stopper.
FIG. 2 is a top view of the container and cap shown in FIG. 1A.
FIG. 3 is a top view of the container shown in FIG. 1B and a stopper with a repeated use receiving means without a cap thereon.
4A is a cross-sectional view of the container taken along line 4-4 of FIG. 1A, a cap with repeated use receiving means, and a cap covering the receiving means; B is the container shown in FIG. 4A. Fig. 4B is an enlarged cross-sectional view of the top of the cap, and a cap and cap with repeated use receiving means; C is an enlarged partial cross-sectional view of the top of the M-shaped repetitive use membrane shown in Fig. 4B; FIG. 6 is a top view of the top of a repeated use diaphragm.
5A is a bottom view of the cap removed from the container shown in FIG. 1A; B is a cross-sectional view of the cap removed from the container shown in FIG. 5A.
6A is a top view of a prior art plug designed to be penetrated by a spike; B is a cross-sectional view of the prior art plug of FIG. 6A; C is a seal in the plug that can be penetrated by various external insertion means. Or a cross-section of the plug of the present invention having a cylindrical projection in the middle of it constituting the diaphragm.
7A is a top view of a multiple use receiving (insertion) means housing; FIG. 7B is a cross section of the multiple use receiving means housing.
FIG. 8 is a cross-section of a plug, a receiving means housing within the plug, and an elastic seal or diaphragm supported by the housing.
FIG. 9 is a cross-sectional view of a stopper used for lyophilization having an M-shaped repeated use diaphragm therein.
10 is a top view of a stopper used for lyophilization having a U-shaped repeated use septum therein shown in the cross-sectional view of FIG. 9. FIG.
FIG. 11 is a cross section of a female luer connector with threads.
FIG. 12A is a cross-sectional view of the female luer connector mating with the receiving means housing shown in FIGS. 7A, 7B and 8, wherein the female luer connector and the receiving means housing are before mating; B is a cross-section of a female luer connector partially mating with the receiving means housing shown in FIG. 12A and breaking the elastic seal; C is a female luer fully mating with the receiving means housing Sectional drawing of a connector.
FIG. 13 is a cross-sectional view of the female luer connector detached from the receiving means housing.
[Explanation of symbols]
10 containers
12 Neck of container
14 Side of container
16 Bottom of container
18 Caps that can be removed
20 Flat top of removable cap
22 Side part of cap that can be removed
24 flexible holding ears
26 Hold button
50 fixed ears
60 Elastic stopper
62 Head of elastic stopper
63 Top surface of elastic stopper
64 Elastic stopper skirt
65 Bottom surface of elastic stopper
66 Flange of elastic stopper
67 Elastic seals of prior art plugs
68 Cylindrical opening of elastic stopper
70 Cylindrical collar on container
71 Open area in the center of the top of the cylindrical collar
72 Bottom edge of cylindrical collar
73 Top of the cylindrical collar
74, 76 Circular edges defining a flat top surface of a cylindrical collar
75 Flat top surface of cylindrical collar
Cylindrical wall defining cylindrical opening of 80, 80 'elastic stopper
82, 82 'Bottom ring part in opening of elastic stopper
83 Funnel-shaped opening in the skirt of the elastic stopper
84, 84 'funnel shaped wall
85 Cylindrical projections (sealing means) constituting the seal in the elastic stopper
86, 86 'cylindrical projection wall
100 Cylindrical housing or male member (accepting means)
102 Cylindrical wall of housing
104 Top surface of housing
106 Bottom surface of housing
108 Inner wall of housing
110 Exterior wall of housing
112 Horizontally-located bottom of housing
120 Inner surface membrane of M-shaped diaphragm
121 Center of inner surface membrane of M-shaped diaphragm
122 A tear in the cup-shaped part of the M-shaped diaphragm
125 The bottom surface of the cup-shaped part of the M-shaped diaphragm
127 Thickness of the unpenetrated film in the central part
140 female luer connector
142 Cylindrical outer wall of female luer connector
143 Cylindrical inner wall of female luer connector
144 Cylindrical ring of female luer connector
146, 148, 150, 152 Thread integral with the inner wall of the female luer connector
160 Tubing in female luer connector
162 Fluid passage conduit in tubing

Claims (16)

A repeated use lid assembly that allows repeated insertion into a medicinal solution contained in a container (10),
The repetitive use lid assembly has an elastic stopper (60) that hermetically seals the container at its open end;
The elastic stopper is
Head (62);
Skirt (64);
A cylindrical opening (68) in the middle of said head (62) and skirt (64) ;
Sealing means having a protrusion (85) in the upper half of the head of the elastic stopper (60), and capable of automatic sealing thereafter each time the drug solution is drawn ;
Means for receiving normal external insertion means, comprising a cylindrical housing (100) having open ends and supporting said projections and having rigidity;
Comprising
A repetitive use lid assembly characterized by: The repeated use lid assembly of claim 1 , wherein the sealing means is integral with the resilient plug. The repeated use lid assembly according to claim 1 , wherein the sealing means is a breakable membrane shaped like an M-shape. The ruptureable membrane having a shape similar to the M- shape
Vertical legs (86, 86 '); and
Extends down towards the bottom of the elastic plug (60) is similar to a cup or U-shaped, the legs (86, 86 ') and Taken together top is making M-shape Surface (120) ,
Have
The breakable membrane is made of a thin elastic material having a tear (122) in its central portion , the tear not completely traversing the bottom (125) of the breakable membrane. Item 4. The repeated use lid assembly according to Item 3 . The breakable film is
Natural rubber;
Acrylate-butadiene rubber;
Cis-polybutadiene;
Chlorobutyl rubber;
Chlorinated polyethylene elastomer;
Polyalkylene oxide polymers;
Ethylene vinyl acetate;
Fluorosilicone rubber;
Hexafluoropropylene-vinylidene fluoride tetrafluoroethylene terpolymer;
Butyl rubber;
Polyisobutene;
Synthetic polyisoprene rubber;
silicone rubber;
Styrene-butadiene rubber;
A tetrafluoroethylenepropylene copolymer; and
Thermoplastic copolyester,
Selected from the group become more inert, gas impermeable, it is a polymer made of material, repeated use lid assembly according to claim 3 or 4. The fracture can be film has a Shore A hardness of from thick to about 25 from about 0.001mm to about 1.00mm to about 80, repeated use lid assembly according to claim 3 or 4. The means for receiving is:
Cartridge ;
Intravenous tubing fitted with a female luer connector (140) ; and
A syringe having a sharp or blunt needle cannula or a sharp or blunt spike ;
To allow connection with the conventional external insertion means selected from the recognized group, repeated use lid assembly according to claim 1. 8. The repeated use lid assembly of claim 7 , wherein the receiving means receives an external female insertion means. The repeated use lid assembly according to claim 8 , wherein the external female insertion means is a female luer connector (140). It said cylindrical housing (100) has a top surface (104) and the bottom surface (106) and a has a cylindrical wall (102),
The cylindrical wall (102), an inner wall (108), an outer wall (110) has fixed ears (50) and horizontally orientation is bottom portion (112),
The fixing ears (50) is designed to securely hold the female luer connector (140), repeated use lid assembly according to claim 1. Furthermore, since said holding elastic stopper (60) firmly in the open end of the container (10), the elastic plug (60) of the fixed covering portion and the neck of the container (10) (12) has a cylindrical collar (70) fixed to,
The cylindrical collar (70), said to allow insertion into the receiving means and sealing means located in the central portion of the elastic plug (60) has a central opening in the flat top portion, The repeated use lid assembly of claim 1 . Furthermore, the flat top (75) and the edge (73) and covers the removal of the cylindrical collar (70) having a can cap (18), repeated use lid assembly of claim 11. Container (10) in claim 1 and a multi-use lid assembly according to, repeated use lid assembly / container combinations. A method of repeatedly inserting into a chemical contained in a container ,
i) providing a container fitted with the repetitive use lid assembly of claim 12;
ii) the flat top portion of the cylindrical collar (70) (75) and remove the edge from (73) said cap (18), thereby receiving said sealing means within said cylindrical opening of the elastic plug (60) it is a means exposed; and iii) inserting the outer insertion means in the chemical, which is placed in a said container (10),
A method for repeatedly inserting into a chemical solution contained in a container . The method according to claim 14 , wherein the liquid medicine is selected from the group consisting of a therapeutic liquid , a diagnostic liquid, and a nutritional supplement liquid . 15. The method further includes returning the lyophilized contents to produce the drug solution by injecting water, saline or other liquid into the container through the repeated use lid assembly. Or 15. The method according to 15 .

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