Closure device for a medical container

• US 20030192791A1
• Filed: 04/18/2003
• Published: 10/16/2003
• Est. Priority Date: 07/07/1999
• Status: Abandoned Application

• Current Assignee: Astrazeneca AB (Astrazeneca PLC)
• Original Assignee: Astrazeneca AB (Astrazeneca PLC)
• Inventors: Nilsson, Billy, Eek, Arne
• Application Number:
  US10/418,058
• Publication Number:
  US 20030192791A1
• Time in Patent Office: Days
• US Class Current: 206/222
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: B65D 51/2814 the additional article or materials being released by piercing, cutting or tearing an element enclosing it

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.

Claims

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.