US20030192791A1 - Closure device for a medical container - Google Patents
Closure device for a medical container Download PDFInfo
- Publication number
- US20030192791A1 US20030192791A1 US10/418,058 US41805803A US2003192791A1 US 20030192791 A1 US20030192791 A1 US 20030192791A1 US 41805803 A US41805803 A US 41805803A US 2003192791 A1 US2003192791 A1 US 2003192791A1
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- United States
- Prior art keywords
- closure device
- opening
- container
- passage
- syringe
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D51/00—Closures not otherwise provided for
- B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
- B65D51/28—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
- B65D51/2807—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
- B65D51/2814—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2055—Connecting means having gripping means
Abstract
A closure device is designed for attachment on a neck portion (1) of a separate container (2), preferably of glass material, which holds a first substance. The closure device defines a passage (10) extending between opposite first and second openings (11, 13) of the closure device. A sealing means (30) is arranged to close off the first opening (11) and confine a second substance in the passage (10). A penetration means (33) is incorporated in the device and operable to penetrate the sealing means (30) such that fluid communication is established between the passage (10) and the container (2). In a method of mixing the first and second substances, a medical practitioner exposes the second opening (13) by removing a non-resealable cap (8), by introducing and engaging the end of a syringe directly in the second opening (13), and by operating the penetration means (33) to penetrate the sealing means (30). By operating the syringe, the practitioner can transfer the first and second substances to the syringe, and mix the same in the process, with minimum need for sterilization.
Description
- The present invention generally relates to containers, such as vials or ampoules, for holding and transferring injectable solutions to a syringe. More specifically, the present invention relates to a closure device for such containers.
- In general, injection solutions are kept in sterile glass vials or ampoules, which are closed off by a suitable seal, such as a rubber stopper or an aluminum foil. Such solutions are injected into a patient by means of a syringe. There are many different forms of syringes that are presently available for use by the medical professions. One particular design difference between various syringes is the manner in which the open end of the syringe is shaped to accommodate a hypodermic needle. The two most popular forms of needle fittings are the friction fit fitting (such as the Luer Slip fitting), and the combination of screw thread and friction engagement fitting (such as the Luer Lock fitting). When a solution is to be injected in a patient, a broad channeled needle is attached to the fitting at the open end of the syringe. This needle is used to penetrate the seal, so that the solution in the vial can be transferred to the syringe. Following transfer, this broad channeled needle is removed from the syringe and replaced with a narrower channeled needle suitable for injecting the solution into the patient. It will be appreciated that this procedure is costly and complicated since it necessitates the use of a number of separate components. Furthermore, since solution transfer for injection into humans requires scrupulous sterilizing of components, this practice requires separate sterilizing measures to be taken at each step.
- These difficulties are at least partly alleviated by the prior art devices known from WO97/39720 and WO98/13006, in which a closure member is mounted on a stopper fitted in a neck portion of a container holding a solution. The closure member includes an axial passage, which extends between first and second openings, the second opening being adapted to receive the end of a syringe. A piercing member is arranged in the passage with a piercing tip at the first opening adjacent to the stopper. The piercing member is arranged such that it is displaced to penetrate the stopper when the end of a syringe is received in the second opening. After penetration of the stopper, the solution can be transferred to the syringe through a channel defined in the piecing member, without the need for any broad channeled needle on the syringe itself.
- However, in some cases it is necessary to prepare an injectable solution by mixing a first substance, liquid or solid, with a second liquid substance, in given proportions before administering the solution to a patient. Typically, such mixing is a complicated procedure, necessitating the use of a number of separate components. Thus, this practice involves an increased risk of contamination and therefore requires separate sterilizing measures to be taken at each step. Further, in many cases the substances must be mixed immediately before administration to a patient, at exact proportions, which can be difficult to achieve.
- The prior art also includes U.S. Pat. No. 5 740 654 which discloses an assembly intended for extemporaneous preparation of solutions and suspensions of a solid active product, the product being enclosed in a container sealed by a stopper fitted in a neck portion thereof. The stopper has an axial channel covered by a thin operculum fixed on the outside face of the stopper. To prepare the solution, a separate connection member is first attached to the neck portion, whereupon a compressible flask holding a liquid product and having a pointed tip portion is opened and screwed into the connection member such that the tip portion of the flask penetrates the operculum, thereby establishing fluid communication between the flask and the container. By compressing the flask, the liquid is caused to pass into the container, where it is mixed with the active product. Then, the flask is repeatedly compressed to transfer the solution back to the container, from where it can be transferred by a syringe, as discussed by way of introduction. This known device includes several components, and exhibits an increased risk of contamination. The use of the device involves several separate steps before the solution can be injected into a patient. Separate sterilizing measures must be taken at each step.
- The object of the invention is to solve or alleviate at least some of the problems described above.
- This object is achieved by the closure device, the container, and the method of preparing a solution by mixing two substances as set forth in appended
claims 1, 28 and 29, respectively. - Since the passage is formed such that a substance can be confined therein, two different substances can be separately enclosed in one and the same packaging and be mixed with each other immediately prior to injection. With the inventive closure device attached to the container, a medical practitioner can access the contents of the container and introduce, and preferably engage, the end of a syringe in the second opening of the closure device. Since both substances enter the syringe from the passage in the closure device, they will be mixed automatically, in the syringe and/or in a chamber defined in the passage connecting the first and second openings. Thus, the inventive closure device both minimizes the need for sterilization and obviates the need for two different needles. Further, the inventive closure device comprises a minimum of parts and is of cost-effective construction.
- The container might contain a unit dose of the first substance. If another unit dose of the second substance is confined in the passage of the closure device, the invention provides the further advantage that the first and second substances will be automatically mixed in known and precise proportions.
- Preferably, the closure device is of unitary or one-piece construction. In one variant, the closure device is formed to replace commonly used seals, such as rubber stoppers or aluminum foils, fitted to the neck portion of the container. In another variant, the closure device holding the second substance is mounted onto an existing conventional seal, such as a rubber stopper or a foil, on the container holding the first substance. One advantage of the latter variant is that the sealed container, with respect to the liquid substance confined therein, can be of conventional design. This should facilitate and shorten the procedure of obtaining an approval for the closure device, and a container having such a closure device, from the competent authorities.
- With the closure device mounted on a conventional rubber stopper, the penetration means preferably comprises a hollow needle for facilitated penetration of the stopper.
- Preferably, a non resealable cap is provided at the second portion to seal the second opening. This allows the medical practitioner to access the contents of the container by simply removing the cap to expose the second opening.
- Preferably, the second end portion comprises a Luer fitting near the second opening, the fitting being adapted for direct fluid tight engagement with the open end of a syringe.
- According to a first aspect of the invention, the penetration means is provided in the passage such that, when the end of a syringe is inserted into the second opening, the penetration means is displaced towards the first opening to penetrate the sealing means that closes off the first opening of the device. Thus, the penetration means is enclosed in a sterile and confined space, minimizing the need for additional sterilization steps during use of the inventive closure device. In one simple construction for penetration of a thin foil closing off the first opening, the penetration means has a cutting element in the shape of an arc extending over more than 180° and less than 360°. Such a cutting element will provide a clean non-closed cut in the foil and minimize the risk of cut-away foil portions falling into the container. Preferably, the cutting element is connected to a stem which extends to the second opening for engagement with the end of the syringe, the periphery of the stem being provided with one or more longitudinal grooves to define a flow path in the passage of the closure device.
- According to a second aspect of the invention, the closure device as such is displaceable towards the container to establish fluid communication between the passage holding the second substance and the container holding the first substance. The penetration means has a first end with a cutting element adapted to rupture the sealing means, a second end sealingly fitted to the first opening, and an internal channel in fluid communication with the first and second ends thereof. Thus, when mounted on the neck portion of the container, the closure device can be displaced towards the container such that the cutting element ruptures the sealing means, thereby establishing fluid communication between the passage and the container and allowing for confined mixing of the first and second substances. Preferably, the sealing means is attached to the first end of the penetration means to close off the internal channel, and indirectly the first opening. The second aspect provides for a device of simple construction, without moving parts, that can be attached to the neck portion of container, for example by a releasable snap fit engagement.
- The invention will now be described in more detail with reference to preferred embodiments of the invention shown in the accompanying drawings.
- FIG. 1a is a cross-sectional view of a closure device according to the first aspect of the invention, and FIGS. 1b-1 d is a perspective view, an elevated side view, and a bottom plan view, respectively, of the penetration means of FIG. 1a.
- FIG. 2 is a cross-sectional view of a variant of the closure device of FIGS. 1a-1 d.
- FIGS. 3a-3 b is a perspective view and a cross-sectional view, respectively, of a closure device according to the second aspect of the invention.
- Referring to FIGS. 1a-1 d, and in particular FIG. 1a, there is shown a first embodiment of the inventive closure device according to the first aspect. The closure device is attached to a
neck portion 1 of acontainer 2, thereby enclosing an injectable solution therein. Thecontainer 2, or at least theneck portion 1 thereof, is generally made of a non-collapsible material, such as glass. The closure device of the first embodiment has abody 3 comprising an engagingportion 4, which is adapted to mate with and engage the inner periphery of theneck portion 1. The engagingportion 4 is joined with ashell portion 5. Aspigot 6 extends from theshell portion 5 to adistal end 7. Aflat grip 8 is connected to thedistal end 7 via a weakenedportion 9, which has a smaller wall thickness than thedistal end 7. Apassage 10 is formed within thebody 3 and extends from aproximate opening 11 defined in anend surface 12 of the engagingportion 4 to adistal opening 13 defined in thedistal end 7, where thepassage 10 is closed off by thegrip 8. Thespigot 6 defines a fitting for engagement with the open end of a syringe (not shown), in this case a Luer Slip fitting, in which the interior of thespigot 6 is adapted to mate with and frictionally engage the outer periphery of the end of the syringe, thereby allowing for a temporary fluid tight engagement therewith. - A
foil 30, preferably of aluminum or aluminum laminate, is attached to thebody 3 of the closure device to close off thepassage 10 at theend surface 12 of thebody 3. Theclosed passage 10 holds a liquid substance, to be mixed with the injection solution in thecontainer 2, as will be explained below. Thepassage 10 consists of a smaller-diameter conduit 31, which is defined in thespigot 6, and a larger-diameter chamber 32, which is defined in the engagingportion 4 and in theshell portion 5. Thechamber 32 opens in theend surface 12 and defines theopening 11 therein. - A
pusher 33, which is shown in more detail in FIGS. 1b-1 d, is slidingly arranged in thepassage 10. Thepusher 33 is preferably of one-piece construction of a material that is compatible with the fluids in the container and the passage, respectively. Thepusher 33 comprises anelongate shaft 34 and aplate 35 at a first end thereof. Elongate recesses 37 extend between the ends of theshaft 34. The outer periphery of theplate 35 is shaped to be snugly received in thechamber 32. Theplate 35 is provided with throughholes 39 connecting the opposite sides of the plate. On the side facing away from theshaft 34, theplate 35 carries anarcuate cutting edge 40 extending essentially in parallel to the perimeter of theplate 35. For reasons given below, it is preferred that thecutting edge 40 forms an arc extending over more than 180° and less than 360°. Thecutting edge 40 comprises anaxial projection 41 facilitating penetration of thefoil 30. - As indicated in FIG. 1a, the
pusher 33 is arranged with thecutting edge 40 adjacent to thefoil 30 sealing theopening 11. Theshaft 34 extends through thechamber 32 and into theconduit 31, such that the second end of theshaft 34 is arranged close to theopening 13. On penetration, thearcuate cutting edge 40 will form a correspondingly arcuate cut in thefoil 30. This cut will define a tongue that can be automatically folded into thecontainer 2 without coming loose, thereby minimizing the risk of cut-away foil portions falling into thecontainer 2. - To access the contents of the
container 2, the user grasps theflat grip 8 and tears it off at the weakenedportion 9, thereby exposing thedistal opening 13 at thedistal end 7. Then, the end of a syringe (not shown) is introduced in thedistal opening 13 to abuttingly engage with thepusher 33. As the end of the syringe is brought into fluid tight engagement with the Luer fitting formed in thespigot 6, thecutting edge 40 of thepusher 33 will be automatically driven through thefoil 30 to establish fluid communication between the syringe and thecontainer 2 via thepassage 10. Thus, when the user operates the syringe to transfer the solution from thecontainer 2 to the syringe, the solution will flow via the throughholes 39 into thechamber 32, where it at least partly mixes with the liquid substance contained therein, before leaving thechamber 32 through channels defined by therecesses 37 and the walls of theconduit 31. Thus, the first embodiment allows two different substances to be separately enclosed in one and the same packaging and mixed with each other immediately prior to injection. Since both substances enter the syringe through theopening 13, they will be mixed automatically, in the syringe and/or in thechamber 32. Following such transfer and mixing, a hypodermic needle can be attached to the end of the syringe for injecting the solution into a patient. Alternatively, the end of the syringe can be brought to direct engagement with an intravenous cannula or the like. - The
body 3 of the closure device in the embodiment shown in FIG. 1a is formed in one piece, preferably by injection moulding, of a plastic material, preferably a nonrigid material such as polyethylene or polypropylene. In assembly, thepusher 33 is first inserted into thebody 3 through theopening 11 in thebody 3. Then, a liquid substance is filled into thepassage 10 through theopening 11. Finally, thefoil 30 is attached to thebody 3 to provide a unitary closure device which can be attached to a filledcontainer 2 in a subsequent step. Withcontainers 2 that conventionally are sealed with rubber stoppers, only minor modification of the sealing equipment is required to replace the rubber stopper with the closure device. Further, standard filling equipment can be used. - In this and the following embodiments, the container can be filled with a solution of any drug which is suitable for injection but is particularly advantageous for use with sterilizable anaesthetic or anaesthetization agents, such as propofol or other drugs which are used under conditions where the demands for easy handling and sterility is high. The inventive closure device is most suited for use with substances that, for example in order not to exhibit reduced potency, should be mixed immediately prior to injection into a patient.
- One example of an injection solution is propofol, which is commonly used both as anaesthetic and as sedative drug. Injection of propofol is frequently associated with pain on intravenous administration. The pain can be reduced by addition of a pH-lowering substance, such as HCl, or a local anaesthetic, such as lidocaine or ropivacaine. Thus, by enclosing propofol in the
container 2, and a pH-lowering substance or a local anaesthetic in the closure device attached thereto, these substances can be administered together. - A second embodiment of a closure device according to the first aspect of the invention is shown in FIG. 2, albeit only in an operative position. As compared with FIG. 1, like elements have been given like reference numerals and a detailed description of such elements will not be repeated.
- Similar to the first embodiment, the closure device of the second embodiment has a
body 3 comprising an engagingportion 4, ashell portion 5, and aspigot 6, the interrelationship of which is described above with reference to FIG. 1. Astopper 20, preferably of resilient material such as rubber, is fitted in theneck portion 1 of thecontainer 2 to confine a substance therein. Preferably, although not shown in FIG. 2, a recess is formed in the top surface of thestopper 20 to facilitate penetration thereof. A sealing means in the form of athin foil 30 is attached to thebody 3 of the closure device to close off theproximal opening 11 and thus thepassage 10. Thedistal opening 13 is sealed off by a suitable non-resealable cap (not shown), such as a foil or a grip of the type shown in FIG. 1a. Like the first embodiment, apusher 33′ is arranged in thepassage 10 of the closure device of the second embodiment. Oneend portion 35′ of thepusher 33′ has the shape of a broad channeled needle, i.e. a hollow needle with acentral channel 39′. Thesharp tip 40′ on one end of theneedle 35′ is arranged adjacent to thestopper 20. The opposite end of theneedle 35′ is attached to ashaft 34′ (not shown in detail) of similar construction as theshaft 34 in the first embodiment (see FIGS. 1b and 1 c). Thereby, there is provided a fluid path for the injection solution from thecontainer 2 to thedistal opening 13, via thechamber 32. In the operative position shown in FIG. 2, the end of a syringe S has been engaged in thedistal opening 13, thereby driving theneedle 35′ through thefoil 30 and thestopper 20 to establish fluid communication between the syringe S and thecontainer 2, via thechamber 32. - The skilled person realizes that there are many alternative structures achieving this function. In one example (not shown), the
pusher 33′ is a long broad channeled needle which extends into theconduit 31 and has lateral perforations communicating theinterior channel 39′ with thechamber 32. The needle might be connected to an annular gasket which is slidingly arranged in theconduit 31 to seal a space defined between the needle and the walls of theconduit 31. The gasket can guide the needle in theconduit 31 and provide a surface for engagement with the end of the syringe S. As a further alternative, there could instead be provided two separate fluid paths in the closure device; one fluid path for the injection liquid from the container to thedistal opening 13, and another fluid path for the liquid substance from thechamber 32 to thedistal opening 13, the mixing being performed in the syringe. - It is also conceivable to fixedly attach the
stopper 20 to thebody 3, for example by means of glue or the like, thereby closing off theproximate opening 11 and forming a unit that can be directly fitted in theneck portion 1 of thecontainer 2. In this case, thefoil 30 can be omitted. - In operation and manufacture, the second embodiment is essentially identical to the first embodiment, and a description thereof will not be repeated. In essence, the second embodiment confers similar advantages as the first embodiment.
- An embodiment of a second aspect of the inventive closure device will now be described with reference to FIGS. 3a-3 b. As compared with FIGS. 1 and 2, like elements have been given like reference numerals, and a detailed description of such elements will not be repeated.
- Similar to the above embodiments, the closure device in FIGS. 3a-3 b has a
body 3 comprising an engagingportion 4, ashell portion 5, and aspigot 6, the interrelationship of which is described above with reference to FIG. 1. Like the embodiments of FIGS. 1 and 2, thepassage 10 consists of a smaller-diameter conduit 31, which is defined in thespigot 6, and a larger-diameter chamber 32, which is defined in theshell portion 5. Thechamber 32 opens in theend surface 12 and defines theproximal opening 11 therein. Ahollow needle 35′ with aninternal channel 39′ is sealingly fitted in theopening 11 and extends to asharp tip 40′. Asheath 30′ of resilient material, such as rubber, is slipped over the needle, thereby forming a bonnet sealing theopen tip 40′ of theneedle 35′. Thus, thesheath 30′ indirectly closes off theopening 11 and confines a liquid substance in thepassage 10. Thedistal opening 13 is sealed off by afoil 8. The engagingportion 4 of the closure device comprises twoparallel extensions 4′ for snap-fit engagement with the neck portion of a container, which holds an injection solution and is closed off by a conventional seal, such as a stopper or a foil. Thus, the closure device of FIGS. 3a-b is designed for releasable attachment on the container with thesharp tip 40′ being arranged adjacent to the seal. - The
body 3 of the closure device shown in FIGS. 3a-3 b is a two-piece construction, preferably formed by injection moulding of a plastic material, preferably a nonrigid material such as polyethylene or polypropylene. More specifically, thebody 3 is formed by joining a lid part, including thespigot 6 and a peripheral flange at one end thereof, to a sleeve part, including theshell portion 5 and the engagingportion 4. The lid part is engaged with the sleeve part at the open end thereof, thereby forming a non-releasable peripheral snap-fit joint 60. The two-piece construction reduces manufacturing costs in that the lid part can be produced with narrow tolerances, as required by the Luer fitting, whereas the sleeve part can be produced with wider tolerances. Evidently, the snap-fit joint 60 could be incorporated in any one of the embodiments of the invention. - In assembly, the
sheath 30′ is slipped on theneedle 35′, whereupon a liquid substance is filled into thepassage 10 through thespigot 6. Then, thefoil 8 is attached to seal thedistal opening 7, thereby providing a unitary closure device that can be attached to a filled container in a subsequent step. - To access the contents of the container, the user pushes the closure device towards the container to drive the
tip 40′ of theneedle 35′ through the seal of the container. In the process, theextensions 4′ align theneedle 35′ perpendicularly to the seal for controlled penetration of the seal. While penetrating the seal, thetip 40′ simultaneously penetrates thesheath 30′ to establish fluid communication between thepassage 10 and the container. Then, the user grasps thegrip portion 8′ and removes thefoil 8 to expose thedistal opening 13. Thereafter, the end of a syringe (not shown) is introduced in thedistal opening 13 and brought into fluid tight engagement with the Luer fitting formed in thespigot 6. When the user then operates the syringe to transfer the solution from the container to the syringe, the solution will flow into thechamber 32, where it at least partly mixes with the liquid substance contained therein, before leaving thechamber 32 through theconduit 31. - It is to be understood that various alterations, modifications and/or additions may be introduced into constructions and parts previously described without departing from the spirit or ambit of the invention as defined in the following claims. In one conceivable alternative, the closure device is formed integrally with the container.
Claims (30)
1. A closure device for attachment on a neck portion (1) of a container (2) holding a first substance, said closure device comprising a first end portion (4) and a second end portion (6), a first opening (11) being defined in the first end portion (4), a second opening (13) being defined in the second end portion (6), and a passage (10) extending within said closure device for fluid communication between the first and second openings (11, 13), characterized by a sealing means (30; 30′) which closes off the first opening (11) and confines a second substance in the passage (10), and a penetration means (33; 33′; 35′) which is operable to penetrate the sealing means (30; 30′) such that fluid communication is established between the passage (10) and the container (2).
2. A closure device according to claim 1 , wherein the second opening (13) is defined in the second end portion (6) to receive the end of a syringe (S) for fluid communication between the passage (10) and the syringe (S).
3. A closure device according to claim 1 or 2, wherein the first end portion (4) is adapted to engage directly or indirectly with the neck portion (1).
4. A closure device according to any one of claims 1-3, wherein the penetration means (33; 33′) is provided in the passage (10) such that, when the end of the syringe (S) is received in the second opening (13), the penetration means (33; 33′) is displaced towards the first opening (11) to penetrate the sealing means (30; 30′).
5. A closure device according to claim 4 , wherein the penetration means (33; 33′) is slidingly arranged in the passage (10) and has a first end with a cutting element (40; 40′) adapted to rupture the sealing means (30; 30′) and a second end adapted to directly or indirectly cooperate with the end of the syringe (S).
6. A closure device according to claim 5 , wherein the cutting element (40; 40′) is arranged adjacent to the sealing means (30; 30′).
7. A closure device according to any one of the preceding claims, wherein said sealing means comprises a breakable foil (30), preferably of aluminum material or an aluminum laminate, which is arranged to close off the first opening (11).
8. A closure device according to any one of the preceding claims, which is adapted to be directly mounted in an opening defined by the neck portion (1) of the container (2).
9. A closure device according to claim 5 or 6, wherein the cutting element (40) is connected to one side of a holder member (35) and projects from said one side essentially in the shape of an arc, said arc extending over more than 180° and preferably less than 360°.
10. A closure device according to claim 9 , wherein a part of said arc forms a leading portion (41) for initial penetration of the sealing means (30).
11. A closure device according to claim 9 or 10, wherein the holder member (35) is snugly received in the passage (10) and is provided with at least one through hole (39).
12. A closure device according to any one of claims 5-7, which is adapted for arrangement on a stopper (20), preferably of rubber material, fitted in the neck portion (1) of the container (2), wherein an internal channel (39′) extends in the penetration means (33′) from the first end thereof, the penetration means (33′) being arranged such that fluid communication is established between the container (2) and the passage (10) through the channel (39′) after penetration of the sealing means (30) and the stopper (20).
13. A closure device according to any one of the preceding claims, wherein the passage (10) comprises a conduit (31) extending from the second opening (13), and a chamber (32) communicating with the conduit (31) and the first opening (11), and wherein the penetration means (33; 33′) is guided in the conduit (31) and extends into the chamber (32), which is wider than the conduit (31) and contains said second substance.
14. A closure device according to claim 13 , wherein the penetration means (33; 33′) comprises a stem (34; 34′) which is connected to the cutting element (40; 40′) and extends into the conduit (31), the outer periphery of the stem (34; 34′) being provided with at least one longitudinal groove (37) defining at least one channel between the stem (34; 34′) and a wall portion of the conduit (31).
15. A closure device according to any one of claims 1-3, wherein the penetration means (35′) has a first end with a cutting element (40′) adapted to rupture the sealing means (30′), a second end sealingly fitted to the first opening (11), and an internal channel (39′) in fluid communication with the first and second ends thereof, wherein said closure device, when mounted on the neck portion (1) of the container (2), allows for displacement towards the container (2) such that the cutting element (40′) ruptures the sealing means (30′), thereby providing the fluid communication between the passage (10) and the container (2).
16. A closure device according to claim 15 , wherein the sealing means (30′), preferably in form of a resilient bonnet, is attached to first end of the penetration means (35′) to close off the internal channel (39′) and thus the first opening (11).
17. A closure device according to claim 15 or 16, wherein the penetration means comprises a hollow needle (35′) which is attached to and projects from the first opening (11).
18. A closure device according to any one of claims 15-17, wherein the first end portion (4) has at least two parallel extensions (4′) adapted to engage with the neck portion (1) and to allow for said displacement while aligning the penetration means (35′) with the container (2).
19. A closure device according to any one of claims 15-18, which is adapted for arrangement on a stopper (20), preferably of rubber material, fitted in the neck portion (1) of the container (2).
20. A closure device according to any one of the preceding claims, wherein the passage (10) is defined in a body (3) comprising a sleeve element (4, 5) and a lid element (6) including the second opening (13), the lid element (6) being attached to an open end of the sleeve element (4, 5) to define the passage (10).
21. A closure device according to any one of the preceding claims, wherein the second end portion (6) at the second opening (13) comprises a Luer fitting, such as a Luer Slip fitting or a Luer Lock fitting.
22. A closure device according to any one of the preceding claims, which is of unitary construction and adapted to be attached to the neck portion (1) of the container (2).
23. A closure device according to any one of the preceding claims, wherein a non-resealable cap (8) is provided at the second end portion (6) to seal the second opening (13).
24. A closure device according to claim 23 , wherein the cap (8) is attached to the second end portion (6) along a weakened section (9) thereof.
25. A closure device according to claim 23 , wherein the cap is a foil (8) attached to the second opening (6).
26. A closure device according to any one of the preceding claims, wherein said second substance is a pH-lowering substance, such as HCl, or a local anaesthetic, such as lidocaine or ropivacaine.
27. A closure device according to any one of the preceding claims, wherein said first substance in the container (2) is a pharmaceutically active drug, preferably propofol.
28. A container having attached thereto a separate closure device as claimed in any one of claims 1-27.
29. A method of preparing a solution by mixing two substances by means of a container according to claim 28 , comprising the steps of inserting the end of a syringe (S) into the second opening (13), operating the penetration means (33; 33′; 35′) to penetrate the sealing means (30; 30′), and operating the syringe (S) to transfer the first and second substances to the syringe (S).
30. A method according to claim 29 , wherein the transfer step comprises transferring the first substance to the passage (10) to mix with the second substance confined therein.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/418,058 US20030192791A1 (en) | 1999-07-07 | 2003-04-18 | Closure device for a medical container |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9902610-6 | 1999-07-07 | ||
SE9902610A SE9902610D0 (en) | 1999-07-07 | 1999-07-07 | Sealing device at medical container |
US67781700A | 2000-09-29 | 2000-09-29 | |
US10/418,058 US20030192791A1 (en) | 1999-07-07 | 2003-04-18 | Closure device for a medical container |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/SE2000/001445 Continuation WO2001003641A1 (en) | 1999-07-07 | 2000-07-05 | Closure device for a medical container |
US67781700A Continuation | 1999-07-07 | 2000-09-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
US20030192791A1 true US20030192791A1 (en) | 2003-10-16 |
Family
ID=20416420
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/418,058 Abandoned US20030192791A1 (en) | 1999-07-07 | 2003-04-18 | Closure device for a medical container |
Country Status (15)
Country | Link |
---|---|
US (1) | US20030192791A1 (en) |
EP (1) | EP1198216A1 (en) |
JP (1) | JP2003504120A (en) |
KR (1) | KR20020028204A (en) |
CN (1) | CN1433293A (en) |
AU (1) | AU770228B2 (en) |
BR (1) | BR0012248A (en) |
CA (1) | CA2375538A1 (en) |
IL (1) | IL147152A0 (en) |
MX (1) | MXPA01013442A (en) |
NO (1) | NO20020035L (en) |
NZ (1) | NZ516099A (en) |
SE (1) | SE9902610D0 (en) |
WO (1) | WO2001003641A1 (en) |
ZA (1) | ZA200110226B (en) |
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WO2005049444A1 (en) * | 2003-11-24 | 2005-06-02 | Guido Rossi Merighi | Monodose food pack |
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US20080290060A1 (en) * | 2005-10-07 | 2008-11-27 | Rainer Ammann | Closure |
US20100116699A1 (en) * | 2007-05-31 | 2010-05-13 | Joseph Sorenson | Supplement compartment for beverage container |
US20110144596A1 (en) * | 2008-09-12 | 2011-06-16 | Jms Co., Ltd. | Spout and liquid container with spout |
US20110180566A1 (en) * | 2008-10-16 | 2011-07-28 | Jms Co., Ltd. | Spout and liquid container with spout |
US8562582B2 (en) | 2006-05-25 | 2013-10-22 | Bayer Healthcare Llc | Reconstitution device |
WO2014202600A1 (en) * | 2013-06-18 | 2014-12-24 | Corporació Sanitària Parc Taulí | Container and method for the storage and extemporaneous reconstitution of a mixture of compounds in fixed proportions |
USD738494S1 (en) * | 2013-03-05 | 2015-09-08 | Ikashmore Pty Ltd | Blood collection safety device |
USD742742S1 (en) * | 2013-07-26 | 2015-11-10 | ViCap Systems Europe Asia AG | Drink flask cap insert |
USD750768S1 (en) | 2014-06-06 | 2016-03-01 | Anutra Medical, Inc. | Fluid administration syringe |
DE102014226900A1 (en) * | 2014-12-23 | 2016-06-23 | B. Braun Melsungen Ag | Closure cap system for a medical fluid storage container |
US9387151B2 (en) | 2013-08-20 | 2016-07-12 | Anutra Medical, Inc. | Syringe fill system and method |
USD763433S1 (en) | 2014-06-06 | 2016-08-09 | Anutra Medical, Inc. | Delivery system cassette |
USD774182S1 (en) | 2014-06-06 | 2016-12-13 | Anutra Medical, Inc. | Anesthetic delivery device |
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WO2010109612A1 (en) * | 2009-03-25 | 2010-09-30 | 株式会社モリモト医薬 | Medical composition container |
US8630908B2 (en) | 2011-11-02 | 2014-01-14 | Avery Dennison Corporation | Distributed point of sale, electronic article surveillance, and product information system, apparatus and method |
WO2017060445A1 (en) * | 2015-10-09 | 2017-04-13 | Fresenius Kabi Deutschland Gmbh | Cover for a container for receiving an enteral nutrition solution |
FR3087336B1 (en) * | 2018-10-19 | 2024-03-22 | Coradin Sas | DEVICE FOR TEMPORARY CONNECTION OF TWO CONTAINERS |
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- 2000-07-05 EP EP20000946723 patent/EP1198216A1/en not_active Withdrawn
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- 2000-07-05 IL IL14715200A patent/IL147152A0/en unknown
- 2000-07-05 CN CN00810031A patent/CN1433293A/en active Pending
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WO2005049444A1 (en) * | 2003-11-24 | 2005-06-02 | Guido Rossi Merighi | Monodose food pack |
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US9393177B2 (en) | 2013-08-20 | 2016-07-19 | Anutra Medical, Inc. | Cassette assembly for syringe fill system |
US9579257B2 (en) | 2013-08-20 | 2017-02-28 | Anutra Medical, Inc. | Haptic feedback and audible output syringe |
US10010482B2 (en) | 2013-08-20 | 2018-07-03 | Anutra Medical, Inc. | Syringe fill system and method |
US10010483B2 (en) | 2013-08-20 | 2018-07-03 | Anutra Medical, Inc. | Cassette assembly for syringe fill system |
USD763433S1 (en) | 2014-06-06 | 2016-08-09 | Anutra Medical, Inc. | Delivery system cassette |
USD774182S1 (en) | 2014-06-06 | 2016-12-13 | Anutra Medical, Inc. | Anesthetic delivery device |
USD750768S1 (en) | 2014-06-06 | 2016-03-01 | Anutra Medical, Inc. | Fluid administration syringe |
DE102014226900A1 (en) * | 2014-12-23 | 2016-06-23 | B. Braun Melsungen Ag | Closure cap system for a medical fluid storage container |
DE102014226900B4 (en) * | 2014-12-23 | 2017-10-26 | B. Braun Melsungen Ag | Closure cap system for a medical fluid storage container |
Also Published As
Publication number | Publication date |
---|---|
MXPA01013442A (en) | 2002-07-02 |
IL147152A0 (en) | 2002-08-14 |
EP1198216A1 (en) | 2002-04-24 |
NO20020035D0 (en) | 2002-01-04 |
CA2375538A1 (en) | 2001-01-18 |
ZA200110226B (en) | 2003-03-12 |
SE9902610D0 (en) | 1999-07-07 |
CN1433293A (en) | 2003-07-30 |
AU6043700A (en) | 2001-01-30 |
AU770228B2 (en) | 2004-02-19 |
NZ516099A (en) | 2003-07-25 |
BR0012248A (en) | 2002-03-26 |
KR20020028204A (en) | 2002-04-16 |
WO2001003641A1 (en) | 2001-01-18 |
NO20020035L (en) | 2002-01-04 |
JP2003504120A (en) | 2003-02-04 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO PAY ISSUE FEE |