JPH11321916A - Repeatedly versatile plug - Google Patents

Abstract

PROBLEM TO BE SOLVED: To insert various kinds of regular externally inserting means such as a syringe in a container by providing a repeatedly versatile lid assembly comprising an elastic plug consisting of a sealing means and a receiving means of the externally inserting means. SOLUTION: An open end of a container is provided with a top surface 63 and a bottom surface 64, and stores an elastic body 60 comprising a head part 62 integrated therewith and a skirt part 64. A cylindrical projection 85 is projected toward the top surface 63 of the elastic plug 60. The cylindrical projection 85 is an M-shaped diaphragm comprising leg parts 86, 86' and a cup-like part. A slit expanding toward a bottom surface of the cup-like part of the M-shaped diaphragm from the top surface, i.e., the inner surface is provided at a lowest point 121 of a top surface 120 of the cup-like part. Even when this diaphragm is broken by the externally inserting means, a fluid path is established and the externally inserting means is detached, re-sealing is effected by the elasticity of the diaphragm. The container can be repeatedly refilled with a chemical.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention relates to an automatic sealing means in which a medicinal solution contained in a container closed by a resilient stopper can be repeatedly inserted by use of a luer connector or syringe having a blunt or sharp needle cannula. The present invention relates to an elastic plug having:

[0002]

2. Description of the Prior Art The prior art has developed a number of devices to prevent accidental needlestick injuries to practitioners and patients. Such damage is known to spread infectious diseases 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 means for insertion into the contents of the container, such as vials, cartridges and bottles. The lid or stopper in these devices serves a dual function of sealing the container while permitting insertion therethrough.

[0003] Plugging systems for containers such as vials and bottles are resistant to chemicals and pharmaceuticals such as corrosives, reagents, parenteral solutions and solid formulations which can be reconstituted with a solvent before use. Made from materials. The most commonly used stopper / container systems for such products have been glass or plastic bottles and vials with stoppers made of elastomeric material. This system provides a good hermetic seal to the contents, safe storage and easy insertion through a resilient stopper by use of an injection spike or syringe when withdrawal of the contents is desired. A commonly used elastic stopper comprises an elastomeric body, such as a natural or synthetic rubber, and an inert coating covering at least a portion of the stopper. Coatings used include chlorobutyl rubber, fluorocarbon polymerized resins such as polytetrafluoroethylene, and various thermoplastic films. The coating is intended to insulate the resilient plug body from the contents of the container to prevent contact between them and possible chemical reactions.

[0004] Generally, the resilient plug has a cylindrical shape and has a flange head lying over the open end of the container. The whole with the head is the main body part that extends into the open end and is located at the neck of the container, and the diameter of the main body part is larger than the inner diameter of the container so that a tight seal can be made between the main part and the container wall. Is also slightly larger. The lower end of the body portion is tilted toward the center of the body portion, the longitudinal axis, to facilitate insertion of the body portion into the container. The circular bottom surface facing the contents of the container is substantially flat with no holes and no recesses therein. The head of the stopper includes a central recess and a central recess extending downwardly away from the substantially top portion of the body portion such that the circular bottom surface defines the septum. The wall forming the recess may be provided with one or more circular protrusions that are generally cylindrical but extend inwardly ending near the centerline of the plug. The circular protrusion serves to push and hold the needle of the syringe as the needle is inserted through the recess to pierce the septum for removal of the contents of the container. The resilient plug is held in place by a metal ring or cap, usually made of aluminum. The metal ring or cap has a central opening that can be removed to allow insertion of the needle into the container.

Various stopper and insertion systems exist in the prior art for holding and removing the contents of the container illustrated below.

One example of a state of the art stopper is shown in FIG.
Report in A and 6B.

[0007] US Pat. 5,429,256 relates to a drug withdrawal system for a vial. This withdrawal system consists of: a vial containing the medicament therein and closed with a rubber gasket; and a device that fits snugly on the top of the vial.
The device consists of a chassis and a cap attached to the cap by movable hinges. 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 fastening adapter that includes a base structure with an external thread and a lower end having a hollow sharp lancet. The device is used with a syringe that has a female luer lock connector that fits into a removable male luer lock adapter that contains a base. In use, the cap cover is opened and the syringe is screwed onto the outer end of the adapter, where the syringe is fastened to the adapter that moves the lancet downward, thereby establishing a flow path with the contents of the vial.

[0008] US Pat. No. 5,433,330 relates to a needleless insertion stopper used for cannulated containers having a blunt stopper penetration tip. The stopper includes a disk and a plug extending from the disk into the container. Also included is a septum defined by a target area on the top surface. This stopper is not suitable for intravenous tubing having syringes, cartridges or female luer connectors. Moreover, after use, the pre-cut disks do not guarantee a complete seal of the contents of the container from the surrounding environment and do not lend themselves to repeated use.

[0009]

The art of providing a multiple use closure system has been disclosed in the art which allows repeated insertion of a medicinal solution contained in a container and at the same time an intravenous tubing or a sharp tube fitted with a cartridge or female luer connector. Alternatively, there is a need to provide an insertion means that allows the insertion of various conventional external insertion means into the container, such as a blunt needle cannula or a syringe having a sharp or blunt spike.

[0010]

SUMMARY OF THE INVENTION The present invention is directed to a health physician and emergency practitioner and sometimes a patient requiring self-injection, an intravenous tubing or a sharp or blunt needle cannula fitted with a cartridge or female luer connector. A variety of conventional external insertion means available, such as a syringe having sharp or dull spikes, or a reusable universal lid assembly that allows repeated insertion of a medicinal solution contained in a container.

According to one aspect, the present invention allows insertion into a drug solution contained in a container that includes an insertion (receiving) and sealing means designed for repeated use such that the drug solution can be repeatedly inserted. To provide a reusable universal lid assembly. After each withdrawal of the desired amount of medicament, the sealing means itself self-seales, thereby preventing contamination of the medicament by airborne particulates such as dust and bacteria.

More specifically, a reusable universal lid assembly according to the present invention comprises: a resilient stopper comprising: sealing means and receiving means for external insertion means.

The elastic plug according to the invention, having a head and a skirt, is made on the basis of an elastic body such as natural or synthetic rubber, preferably on at least the part of the plug which is in contact with the chemical solution. Has an inert polymer coating covering. The coating may be a chlorobutyl rubber, a fluorocarbon polymer resin and a thermoplastic film.

The resilient stopper is cylindrical in shape and has a flange head over 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 the same as that of the neck of the container so that a tight seal is created between the skirt and the wall of the container. It is slightly larger than the inside diameter.

The central portion of the resilient plug has a cylindrical opening extending through the head and skirt of the plug. A cylindrical opening through the plug will expose the contents of the container to an environment that allows for contamination therefrom. According to the invention, the cylindrical opening is closed by a sealing means, ie a breakable sealing membrane. The breakable sealing membrane may be made separately from the resilient stopper, placed in the opening, and sealed within the resilient stopper using a thermoplastic or other sealing means known in the art. Preferably, the elastic plug and the sealing membrane are both integral and manufactured by blow molding or other suitable manufacturing techniques. The sealing membrane is preferably a projection inherent in the upper half of the head of the resilient plug and a vertical leg or cylindrical side wall; and a cup or U-shaped extending down towards the bottom of the resilient plug And, when considered together with the cylindrical side wall, is a shape resembling an M-shape consisting of a top surface forming an M-shape. The rupturable sealing membrane is made of a thin elastomeric material, preferably with a not completely traversed tear in its central part.

The M-shaped sealing membrane in the resilient stopper will collapse or at least deform when pierced by a luer connector, a sharp or blunt injection cannula. 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 (inserting) means for the external insertion means. The external insertion means is preferably a female insertion means such as a female luer connector. Such external insertion means is threaded into the male coupling means, thereby breaking the sealing membrane to establish a fluid passage with the contents of the container.

The reusable universal lid assembly further comprises a cylindrical collar and an even more removable cap.

A cylindrical collar, preferably made of metal such as aluminum, is secured over the resilient stopper and the neck of the container to hold the resilient stopper at the open end of the container. The cylindrical collar includes on its flat top a cylindrical opening of the stopper and a sealing membrane located in the cylindrical opening and a central opening allowing insertion into the receiving means (male member).

The removable cap covers the flat top and edge of the cylindrical collar and includes a retaining ear that fits into the cylindrical collar to keep the lid assembly sterile.

According to another aspect, the present invention provides a reusable universal lid assembly / container combination comprising: a container; and a reusable universal lid assembly according to the present invention.

According to yet another aspect, the present invention provides a method for repeated insertion into a drug solution contained in a container equipped with a reusable universal lid assembly of the present invention comprising the following steps: i) Providing a reusable universal lid assembly / container combination of the invention; ii) removing the removable cap from the flat top and edge of the cylindrical collar, thereby sealing and receiving means within the cylindrical opening of the resilient plug. And iii) inserting the external insertion means into the drug solution contained in the container.

The present invention provides a means for sealing and inserting into a container, such as a glass or plastic bottle or vial, containing a drug solution, such as an X-ray contrast agent or a parenteral liquid.
The insertion means of the lid assembly of the present invention is a hermetic sealing,
Provides what is needed for safe handling, sterilization and storage. The sealing means is designed for repeated use so that the medicinal solution can be inserted repeatedly. After each withdrawal of the desired amount of medicament, the sealing means itself self-seales, thereby preventing contamination of the medicament by airborne particulates such as dust and bacteria. For simplicity, the invention will be described in combination with a glass vial. It should be understood, however, that the present invention generally includes a sealing or receiving (inserting) means for a container comprising a rigid or semi-rigid insertion opening and capable of receiving such a sealing or inserting means.

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 keep it sterile and preservative.

Although the present invention provides for insertion into a drug solution using a variety of external insertion means, the insertion means may be similar to a sharp needle cannula to prevent accidental injury and transmission of infectious diseases such as AIDS. Preferably not "sharp".

The external insertion means is preferably a syringe, cartridge or intravenous tubing having a female luer connector. However, other insertion means, such as a syringe having a sharp or blunt needle cannula or spike, may also 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, a container 10 is opened such that the reusable universal plug used comprises a neck 12, a side 14 and a bottom 16. Has an edge. 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 the top, said open area being a circular edge represented by the numeral 74. Stipulated by
A reusable universal plug will be installed. The cylindrical collar further comprises a flat top surface 75 and a top 73 defined by circular edges 74 and 76. The cylindrical collar 70 is folded into the neck 12 of the container at its bottom edge 72. The flat top surface 75 is covered by a cylindrical removable cap 18 consisting of the flat top 20 and the side 22 overlapping the top 73 of the cylindrical collar 70. FIG. 1B shows a fixed ear 50 that forms part of a universal plug described below with reference to other figures as the present invention proceeds.

Referring to FIGS. 1A, 1B, 5A and 5B,
The removable cap 18 covers the flat top surface 75 and the top side 73 of the cylindrical collar to keep the central open central area 71 and the fixed ear 50 sterile during storage. Removable cap 18: side 2
2, consisting of a flexible holding ear 24 and a holding button 26.
In place, the retaining ear 24 slides under the circular rim 74 of the cylindrical collar 70 and the removable cap 1
8 and provides a tight seal between the flat top surface 75 of the cylindrical collar. Holding button 26 with holding ear 24
It also helps to limit the expansion of the thin elastic membrane or seal during sterilization.

FIGS. 1A, 1B, 4A, 4B, 6A, 6B,
Referring to 6C and 8, the open end of the container 10 has a top surface 63 and a bottom surface 65 and contains an elastic plug 60 comprising a head 62 and a skirt 64 integral therewith.
The head comprises a flange 66 extending laterally outward from the skirt 64 and is designed to cover the transverse end face of the container. 6A and 6B are commonly used according to the prior art. As best seen in FIGS. 4B and 8, the resilient plug in the present invention further comprises: a cylindrical opening 68 at its center defined by cylindrical walls represented by numerals 80 and 80 '; numerals 82 and 82 And a funnel-shaped opening 83 extending downward into the container from the bottom ring defined by walls 84 and 84 '. Top surface 63 of elastic plug 60
Protruding upwardly is a hollow, vertically oriented cylindrical projection 85 defined by cylindrical walls 86 and 86 ′ and a top surface 120. Along with the cylindrical walls 86 and 86 ',
Top surface 120 is designed to serve as a resilient seal in a resilient plug. The cylindrical projection is preferably integral with the plug body, such as made by blow molding techniques, or it is made separately and sealed into a central opening defined by walls 80 and 80 'within the resilient plug 60. You may.

The vertically oriented cylindrical projection is made of a thin film-like material designed to be broken by external forces exerted on the projection by external insertion means such as a Luer connector.
As best seen in FIGS. 4C and 4D, which show cross-sections and top views, the cylindrical projections have numbers 86 and 86 'representing the legs and number 120 representing the cup-like top surface. It is an M-shaped diaphragm. The lowest point of the top surface 120 is the midpoint of the cup-shaped part and is represented by the numeral 121. At the lowest point 121 is a fissure 1 extending from the top or inner surface to the bottom 125 of the cup-shaped portion of the M-shaped diaphragm.
22 are provided. However, the fracture does not penetrate to the bottom surface 125. The thickness between the split 122 and the intact bottom surface 125 is typically from about 0.001 to about 2.0 mm. The non-penetrated part of the membrane, representing its thickness in the central part, is designated by the numerals 127, 127 'in FIGS. 4C and 4D. An unpenetrated membrane keeps 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 reusable universal plug, the cup-shaped portion of the septum reseals itself because the membrane is elastic and rebounds to its original shape. As a result, the container is resealed until the drug withdrawal process is repeated.

Referring to FIGS. 7A, 7B and 8, in order to provide a means for supporting a vertically oriented cylindrical projection 85 and for receiving a male luer connector, generally 10.
A cylindrical housing or male member (receiving means), indicated at 0, is provided at the upper center 68 of the resilient plug 60. Housing 100: top surface 104 and bottom surface 1
06 comprises a cylindrical wall 102. 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 securely hold the female member of the luer connector. The horizontally oriented bottom 112 extends into the skirt 64 and is sealed thereto by the bottom ring portions 82 and 82 ′ of the resilient plug 60.

The cylindrical projection serving as the 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.
If possible, the membrane should be about 0.001mm to about 2.00mm
And a Shore A hardness of about 25 to about 80. Elastic materials suitable for constructing the membrane are: natural rubber; butadiene acrylate rubber; cis-polybutadiene; chlorobutyl rubber; chlorinated polyethylene elastomer; polyalkylene oxide polymer; ethylene vinyl acetate; fluorosilicone rubber; Hexafluoropropylene-vinylidene fluorinated tetrafluoroethylene terpolymer, such as that sold under the trade name; butyl rubber, such as that sold under the trade name Vistanex,
Polyisobutene; synthetic polyisoprene rubber; silicone rubber; styrene butadiene rubber; tetrafluoroethylene propylene copolymer;
including.

The cylindrical M-shaped projection is positioned within the resilient plug 60 such that when the cap is placed on the container 10, its top surface 120 is about 2-3 mm away from the retaining button 26 of the removable cap 18. You. This spacing allows the membrane to deflect outward under pressure such as occurs under heat sterilization. However, this spacing should not be greater than about 2-3 mm so that in the event of high pressure, rupture of the membrane is prevented by the retaining button 26 of the removable cap 18.

The reusable universal lid assembly of the present invention may have the shape shown in FIGS. A stopper of this shape is used when lyophilization of the contents of the container is desired. Prior to use, the lyophilized contents are returned by pouring water, saline or other liquid into the container through a multi-use universal stopper.

The universal lid assembly of the present invention is preferably used with an external female luer connector when a fluid passage to the contents of the container plugged by the universal stopper is desired. An exemplary female luer connector 140 is shown in FIG.
And a cylindrical inner wall 143 having an opening in the center thereof for receiving the tubing therein. Cylindrical inner wall 14
A cylindrical ring 144 located at the top center of 3 holds the tubing 160 with the conduit 162 of the fluid passage. Cylindrical inner wall 143 further includes an integral fitting that engages the fixed ear 50 on the housing or male member 100 when connecting the female luer connector to the male luer connector, as shown in FIGS. 7A and 7B. Thread 146, 148, 1
50 and 152. Other types of female luer connectors, such as snap connectors, can also be used.

FIGS. 12A-C show cross-sectional views of a syringe having a female luer connector that mates with a reusable universal plug on container 10, showing the syringe and universal plug before mating. I have. When it is desired to inject the medicament from the container 10 into the patient, the removable cap 18 is removed by an upward hand force applied to its side 22, thereby exposing the fixed ear 50 of the insertion means housing. To

If the female luer connector of FIG. 11 is used, it may be thread 146, 148, 15
0 and 152 are fixed ears 50 of the insertion means housing 100.
Attached to the reusable universal lid assembly by a torsional motion that fits into the. By turning the female luer connector 140, the end of the tubing 160 breaks the universal plug membrane to establish a fluid path with the contents of the container.

FIG. 12B shows a cross-sectional view of a syringe having a female luer connector partially mating with a reusable universal lid assembly.

FIG. 12C shows a cross-sectional view of a syringe having a female luer connector fully mated with a reusable universal lid assembly.

FIG. 13 shows a cross-sectional view of a syringe having a female luer connector removed from the reusable universal lid assembly after mating.

The reusable universal lid assembly can be mated with an external female luer connector having a blunt end that mates and breaks the cylindrical M-shaped seal in the center of the reusable universal lid assembly. However, the reusable universal stopper allows insertion into the contents of the container even with a sharp or blunt needle cannula or spike. Materials of Construction and Use Elastic stoppers used with the universal stoppers of the present invention are fluid-impermeable, resilient, with no leachable additives therein to prevent any alteration of the product contained in the container. Yes and inert. It can be 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.
Synthetic elastomer detailed example of rubber Viton (R) and Kalrez CH ₂ CF ₂ -C ₃ manufactured by DuPont under the trade name (R) F ₆
(C ₃ F ₅ H) and C ₂ F ₄ —C ₂ F ₃ OCF ₃ series elastomers; fluorosilicone rubbers such as those manufactured by Dow Corning under the trade name Silastic®; and Vistanex M
Polyisobutylenes such as ML-100 and MML-140; and halogenated butyl rubbers such as chlorobutyl 1066 from Exxon Chemical.

These or other elastomers are formed into the desired stopper shape by known methods. Such methods usually involve the use of curing agents, stabilizers and fillers and consist of primary and secondary curing stages at elevated temperatures.

The container used in connection with the present invention is made of glass or a polymeric material, ie a plastic well known in the pharmaceutical industry. If the container is made of glass, it is in the form of a vial or bottle. The vial or bottle is made of a rigid or semi-flexible polymeric material. In all forms, the container has a neck that is rigid and retains its shape so that it is capable of being hermetically sealed by the elastic universal stopper of the present invention. Containers from 5ml to 1000ml or more preferably about 10m
It has a capacity of 1 to 500 ml.

The mouth of the container contains a reusable universal lid assembly. Upon insertion of the reusable universal stopper into the mouth of the container, 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.

The cylindrical collar is preferably made of a metal such as aluminum, while the housing is made of a rigid plastic known in the prior art and used with a chemical.

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 reusable universal stopper is inserted while sealing the contents of the container. The cylindrical collar is then pushed over the container to securely hold the reusable universal lid assembly in the container. Finally, a removable cap is snapped onto the cylindrical collar to complete the closure of the container.

[Brief description of the drawings]

1A is a perspective view of a container, a stopper with repeated use receiving (insertion) means and a cap covering the insertion means; FIG. 1B is a perspective view of the container shown in FIG. FIG.

FIG. 2 is a top view of the container and the cap shown in FIG. 1A.

FIG. 3 is a top view of the container shown in FIG. 1B and a stopper with reusable receiving means without a cap thereon.

4A is a cross-sectional view of the container taken along line 4-4 of FIG. 1A and a cap with reusable receiving means and a cap covering the receiving means; FIG. 4B is the container shown in FIG. 4A. 4C is an enlarged cross-sectional view of the top and the stopper and the cap with the repetitive receiving means; C is an enlarged partial cross-sectional view of the top of the M-shaped repetitive diaphragm shown in FIG. 4B; D is an M-shaped shown in FIG. 4B. FIG. 4 is a top view of the top of a reusable diaphragm.

5A is a bottom view of the cap removed from the container shown in FIG. 1A; FIG. 5B 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 stopper designed to be pierced by a spike; B is a cross section of the prior art stopper of FIG. 6A; C is a seal in the stopper that can be penetrated by various external insertion means. Or a cross-section of a plug according to the invention having a cylindrical projection in the center of it constituting a diaphragm.

7A is a top view of the reusable receiving (insertion) means housing; FIG.

FIG. 8 is a cross section of a closure, a receiving means housing within the closure and an elastic seal or septum supported by the housing.

FIG. 9 is a cross-sectional view of a stopper used for lyophilization having an M-shaped reusable diaphragm therein.

FIG. 10 is a top view of a stopper used for lyophilization having a U-shaped reusable septum therein shown in the cross-sectional view of FIG.

FIG. 11 is a cross section of a female luer connector having a thread.

FIG. 12A shows a cross-section of a female luer connector mating with the receiving means housing shown in FIGS. 7A, 7B and 8, where the female luer connector and the receiving means housing have not yet mated; B is a cross section of a female luer connector partially mating with the receiving means housing shown in FIG. 12A and breaking the resilient 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 Container 12 Container Neck 14 Container Side 16 Container Bottom 18 Removable Cap 20 Removable Cap Flat Top 22 Removable Cap Side Side 24 Flexible Retaining Ear 26 Retaining Button 50 Fixed Ear 60 Retaining Plug 60 Elastic Plug 62 elastic stopper head 63 elastic stopper top surface 64 elastic stopper skirt 65 elastic stopper bottom surface 66 elastic stopper flange 67 prior art stopper elastic seal 68 elastic stopper cylindrical opening 70 cylindrical collar on container 71 an open area at the top center of the cylindrical collar 72 bottom edge of the cylindrical collar 73 top edge of the cylindrical collar 74, 76 circular edge defining the flat top surface of the cylindrical collar 75 Flat top surface 80, 80 'Cylindrical wall defining the cylindrical opening of the elastic plug 82, 82' Bottom ring portion within the opening of the elastic plug 83 Elastic Funnel-shaped opening in the skirt of the plug 84, 84 'Wall of the funnel-shaped opening 85 Cylindrical projections (sealing means) constituting the seal in the elastic plug 86, 86' Wall of cylindrical projections 100 Cylindrical housing or male (Receiving means) 102 cylindrical wall of housing 104 top surface of housing 106 bottom surface of housing 108 inner wall of housing 110 outer wall of housing 112 horizontally oriented bottom of housing 120 inner surface film of M-shaped diaphragm 121 M-shaped The middle of the inner surface membrane of the m-type membrane 122 The cleft in the cup-shaped part of the M-shaped membrane 125 The bottom surface of the cup-shaped part of the M-shaped membrane 127 The thickness of the non-penetrated membrane in the central part 140 Female luer Connector 142 Cylindrical outer wall of female luer connector 143 Cylindrical female luer connector Wall 144 female luer connector of a cylindrical ring 146,148,150,152 female luer connector of the inner wall and the fluid passage conduit tube 162 tubing in the integral threads 160 female luer connector

 ──────────────────────────────────────────────────続 き Continuation of front page (72) Inventor Mark E. Gabbard, Delaware, USA 19940, Delmar, Box 47-13, RT2 (72) Inventor Timothy Jay. Gabbard 21804, Maryland, United States, Salisbury, Terrace Hello Run 3951

Claims (37)

[Claims] 1. An elastic plug (6) comprising sealing means capable of automatically performing subsequent sealing every time a chemical solution is withdrawn.
0); and means for receiving conventional external insertion means; and a reusable universal lid assembly that allows for repeated insertion into a drug solution contained in a container (10). 2. The elastic plug (60) hermetically sealing the container (10) at its open end comprises: a head (62); a skirt (64); the head (62) and a skirt (6).
The universal lid assembly according to claim 1, comprising a cylindrical opening (68) in the center of 4); and said sealing means. 3. The universal lid according to claim 1, wherein said sealing means is integral with said elastic plug. 4. The universal lid according to claim 1, wherein said sealing means is a projection (85) inherent in the upper half of the head of the elastic plug (60). 5. The reusable universal lid assembly according to claim 1, wherein said sealing means is a breakable membrane having a shape resembling an M-shape. 6. The M-shaped self-sealing rupturable membrane of the shape resembles: vertical legs (86, 86 ′); cups extending downward towards the bottom of the elastic plug (60) or U
A top surface (120) that resembles a letter shape and creates an M-shape when considered together with the legs (86, 86 '); completely traversing the bottom (125) of the sealing membrane in its central part 6. The universal lid of claim 5, wherein said rupturable sealing membrane is made of a thin resilient material having an open tear. 7. The rupturable membrane is: natural rubber; acrylate-butadiene rubber; cis-polybutadiene; chlorobutyl rubber; chlorinated polyethylene elastomer; polyalkylene oxide polymer; ethylene vinyl acetate; fluorosilicone rubber; hexafluoropropylene-vinylidene. Inert gas selected from the group consisting of fluorinated tetrafluoroethylene terpolymer; butyl rubber; polyisobutene; synthetic polyisoprene rubber; silicone rubber; styrene-butadiene rubber; tetrafluoroethylene propylene copolymer; The universal lid according to claim 5, wherein the universal lid is made of an impermeable polymer material. 8. The universal lid assembly according to claim 5-7, wherein the rupturable membrane has a thickness from about 0.001 mm to about 1.00 mm and a Shore A hardness from about 25 to about 80. 9. The rupturable membrane is resealed by itself after being pierced by external insertion means.
9. The universal lid assembly according to 8. 10. The receiving means is a cartridge or any conventional external device such as an intravenous tubing fitted with a female luer connector (140) or a syringe having a sharp or blunt needle cannula or a sharp or blunt spike. The universal lid assembly according to claim 1, wherein the universal lid assembly allows connection with the insertion means. 11. The universal lid assembly according to claim 10, wherein said receiving means receives external female insertion means. 12. The universal lid assembly according to claim 11, wherein said external female insertion means is a female luer connector (140). 13. The universal lid assembly according to claim 1, wherein said receiving means is a cylindrical housing (100). 14. The cylindrical housing (100) is located in the upper center of the resilient plug (60) and comprises: a cylindrical wall (102) having a top surface (104) and a bottom surface (106). Said cylindrical wall (102) comprises an inner wall (108), an outer wall (110), a fixed ear (50) and a horizontally oriented bottom (112); said fixed ear (50) being a female screw. The lid assembly according to claim 13, designed to securely hold the L connector (140). 15. An elastic plug (60) for securely holding the elastic plug (60) at the open end of the container (10).
And a cylindrical collar (70) secured over a portion of the neck (12) of the container (10), said cylindrical collar (70) being located in the central portion of the resilient plug (60). 15. A central opening at its flat top to allow insertion into the receiving and sealing means.
A universal lid assembly according to claim 1. 16. The system according to claim 1, further comprising a removable cap (18) covering a flat top (20) and an edge (22) of said cylindrical collar (70).
6. The universal lid assembly according to 5. 17. A reusable universal lid assembly / container combination comprising a container (10) and a reusable universal lid assembly according to claim 1-16. 18. A container (10) containing a drug solution therein and having a neck (12) ending at an open end; and (b) inserted into the open end of said container (10). (1) The elastic stopper (60) for hermetically sealing the container (10) at its open end includes: a head (62); a skirt (6).
4); a cylindrical opening (68) in the center of the head (62) and the skirt (64); serving as a diaphragm sealing the opening in the center of the elastic plug (60) designed to be broken by external force. Consisting of a hollow, vertically oriented thin elastic projection (85), said elastic projection (85) extending downwards towards the bottom of the vertical leg (86, 86 '); elastic plug (60). A top surface (120) that resembles a cup or U-shape and that, when considered together with the legs (86, 86 '), forms an M-shape; (2) having a generally M-shaped configuration comprising said rupturable sealing membrane made of a thin elastic material having a split (122) that does not completely traverse 125); ) The rigid cylindrical housing (100) is A female luer connector (140) that supports the thin elastic projection (85) in a straightened position and penetrates the thin elastic projection (85) to establish a fluid passage with the chemical solution contained in the container (10). Having an open end surrounding said vertically oriented thin elastic projection (85) which serves as a means for receiving and mating a female luer connector (140) by externally moving said rigid body. The cylindrical housing (100) has: a top (104) and a bottom (10).
6), comprising a cylindrical wall (102) having a top (104) with a female part (14) of a luer connector.
(3) has fixed ears (50) designed to hold the 0) and the bottom (106) is encapsulated in the skirt (64) of the elastic plug (60); A cylindrical collar (7) secured over the elastic stopper (60) and a portion of the neck (12) of the container (10) to securely hold the elastic stopper (60) within the open end of the container (10).
0), said cylindrical collar (70) is said elastic stopper (60)
A central opening at its flat top to allow insertion into the rigid cylindrical housing (100) and a resilient projection (85) located at the center of the housing; To maintain the cylindrical collar (7
0) said cylindrical collar (7) including retaining ears fitted to it.
A universal lid assembly / container combination comprising the removable top (18) covering the flat top (75) of 0) and the rim (73). 19. The rupturable membrane is: natural rubber; acrylate-butadiene rubber; cis-polybutadiene; chlorobutyl rubber; chlorinated polyethylene elastomer; polyalkylene oxide polymer; ethylene vinyl acetate; fluorosilicone rubber; hexafluoropropylene-vinylidene. Inert gas selected from the group consisting of fluorinated tetrafluoroethylene terpolymer; butyl rubber; polyisobutene; synthetic polyisoprene rubber; silicone rubber; styrene-butadiene rubber; tetrafluoroethylene propylene copolymer; 19. The combination of claim 18, wherein the combination is made of an impermeable polymeric material. 20. The rupturable film has a thickness of about 0.001 mm.
20. The combination of claims 18-19, wherein the combination has a thickness of from about 1.00 mm to a Shore A hardness of from about 25 to about 80. 21. The rupturable membrane reseals itself after being breached by external insertion means.
The combination according to 0. 22. A method of repeatedly inserting a drug solution contained in a container fitted with a reusable universal lid assembly by a variety of readily available external insertion means: i) a repetition comprising a container and a reusable universal lid assembly. Providing a universal lid assembly / container combination for use; said lid assembly includes: (1) a resilient stopper (60) including a sealing means capable of subsequent automatic sealing with each withdrawal of the drug solution; and (2) external insertion means. Ii) removing the removable cap (18) from the flat top (75) and the rim (73) of the cylindrical collar (70), thereby removing the cylindrical opening of the resilient plug (60). Exposing the sealing means and the receiving means therein; and iii) inserting the external insertion means into the medicament contained in the container (10). The method that is Ri. 23. The elastic plug (60) hermetically sealing the container (10) at its open end comprises: a head (62); a skirt (64); 23. The method according to claim 22, comprising a central cylindrical opening (68); and said sealing means. 24. The sealing device according to claim 19, wherein the sealing means is provided with the elastic plug (6).
24. The method of claims 22-23, wherein the method is integral with 0). 25. The resilient plug (60) wherein the sealing means is an elastic plug (60).
25. The method according to claims 22-24, wherein the protrusion is a protrusion (85) underlying the upper half of the head. 26. The method according to claim 22, wherein said sealing means is a breakable membrane having a shape resembling an M-shape. 27. The M-shaped self-sealing rupturable membrane of the shape resembling: vertical legs (86, 86 ′); cups extending downward towards the bottom of the elastic plug (60) or The top surface (120) resembling a U-shape and forming an M-shape when considered together with the legs (86, 86 '); complete the bottom (125) of the sealing membrane which can be broken at its central part. 27. The method of claim 26, comprising the rupturable sealing membrane made of a thin elastic material having a rupture (122) that does not traverse through. 28. The rupturable membrane is: natural rubber; acrylate-butadiene rubber; cis-polybutadiene; chlorobutyl rubber; chlorinated polyethylene elastomer; polyalkylene oxide polymer; ethylene vinyl acetate; fluorosilicone rubber; hexafluoropropylene-vinylidene. Inert gas selected from the group consisting of fluorinated tetrafluoroethylene terpolymer; butyl rubber; polyisobutene; synthetic polyisoprene rubber; silicone rubber; styrene-butadiene rubber; tetrafluoroethylene propylene copolymer; 28. The method of claims 26-27, wherein the method is made of an impermeable polymeric material. 29. The rupturable membrane has a thickness of about 0.001 mm.
29. The method of claims 26-28, wherein the method has a thickness from about 25 to about 1.00 mm and a Shore A hardness from about 25 to about 80. 30. The rupturable membrane is resealed by itself after being pierced by external insertion means.
The method according to 6-29. 31. The receiving means may be a cartridge or an intravenous tubing fitted with a female luer connector (140) or any conventional external device such as a syringe having a sharp or blunt needle cannula or a sharp or blunt spike. 23. The method according to claim 22, wherein the connection is also possible with the insertion means. 32. The method of claim 31, wherein said receiving means receives external female insertion means. 33. The method of claim 32, wherein said external female insertion means is a female luer connector. 34. The method of claim 22, wherein said drug solution is a therapeutic liquid. 35. The method according to claim 22, wherein the medicinal liquid is a diagnostic liquid. 36. The method of claim 22, wherein said medicinal solution is a nutritional liquid. 37. The lyophilized content is returned through the reusable universal lid assembly by injecting water, saline or other liquid into the container.
A method according to claims 22-36.