Closure device for a medical container

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.

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.