Sliding reconstitution device for a diluent container

• US 20040199139A1
• Filed: 12/23/2003
• Published: 10/07/2004
• Est. Priority Date: 09/15/1998
• Status: Active Grant

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Weinberg, Robert J., Fowles, Thomas A.
• Granted Patent: US 7,425,209 B2
• Time in Patent Office: Days
• US Class Current: 604/414
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• 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

Abstract

The present invention provides a connector device or reconstitution device (10) for placing a first container (12), such as a liquid container (e.g. flexible container or syringe), in fluid communication with a second container (14), such as a drug vial. The connector device (10) has a first sleeve (32) having a first end (36) and a second end (38). The first sleeve (32) has at the first end (36), a first attaching member (30) adapted to attach to the liquid container (12). The connector device (10) also has a second sleeve (34) having a first end (48) and a second end (50). A second attaching member (28) is attached on the second end (50) of the second sleeve (34) and is adapted to attach to the second container (14). The second attaching member (28) has a sealing member (84). A piercing member (76) projects within the sleeves (32,34) for providing a fluid flow path from the first container (12) to the second container (14). The connector device (10) is movable from the inactivated position to the activated position wherein the second sleeve (34) moves axially with respect to the first sleeve (32) and wherein the piercing member places the first container (12) and the second container (14) in fluid communication. The connector device (10) includes structure for preventing premature activation of the connector device (10).

Claims

1. A connector for establishing fluid communication between a first container and a second container comprising:

a first sleeve adapted to be connected to the first container;

a second sleeve adapted to be connected to the second container, the second sleeve being associated with the first sleeve and movable axially with respect thereto from an inactivated position to an activated position; and

means for preventing premature activation of the connector.

2. The connector of claim 1 further comprising a piercing member positioned in the sleeves, the piercing member having a fluid pathway.

3. The connector of claim 2 wherein the fluid pathway is adapted to provide a fluid flow path between the first container and the second container when the device is in the activated position.

4. The connector of claim 2 wherein the fluid pathway is adapted to not be in fluid communication with the first container and the second container when the device is in the inactivated position.

5. The connector of claim 2 wherein the piercing member comprises a first piercing member connected to a second piercing member.

6. The connector of claim 5 wherein the first piercing member is a plastic spike.

7. The connector of claim 5 wherein the second piercing member is a metal cannula.

8. The connector of claim 2 wherein the piercing member has a hub.

9. The connector of claim 2 wherein the piercing member has a plurality of wings.

10. The connector of claim 2 wherein the piercing member comprises a plastic spike integral with a hub, and a metal cannula connected to the plastic spike.

11. The connector of claim 1 wherein the first sleeve is positioned within the second sleeve.

12. The connector of claim 1 further comprising a sealing member positioned between the first sleeve and the second sleeve.

13. The connector of claim 11 wherein the first sleeve has a first end and a second end, the first sleeve defining a groove proximate the second end, and a sealing member received by the groove and abutting an inner surface of the second sleeve providing a seal between the first sleeve and the second sleeve when the connector is in the inactivated position.

14. The connector of claim 11 wherein the first sleeve has a first end and a second end, the first sleeve having a stop surface at the second end, the second sleeve having a ledge wherein the stop surface engages the ledge in the inactivated position.

15. The connector of claim 13 wherein the second sleeve has a first section and a second section, the sealing member positioned at the first section.

16. The connector of claim 15 wherein the second section of the second sleeve has a larger diameter than a diameter of the first section, wherein when the sleeves move from the inactivated position to the activated position, the sealing member moves to the second section and does not provide a seal between the first sleeve and the second sleeve.

17. The connector of claim 8 wherein the second sleeve has a ledge, the hub engaging the ledge when the sleeves are in the inactivated position.

18. The connector of claim 2 wherein the second sleeve has a protuberance, the protuberance engaging the piercing member when the connector is moved to a deactivated position.

19. The connector of claim 8 wherein the second sleeve has a projection, the projection engaging the hub when the connector is in the inactivated position.

20. The connector of claim 17 wherein the second sleeve has a projection, the hub positioned between the ledge and projection when the connector is in the inactivated position.

21. The connector of claim 2 wherein the first sleeve has a first end and a second end, the first sleeve having a guide proximate the first end, the piercing member having a first end positioned proximate the guide.

22. The connector of claim 1 wherein the first sleeve has a first attaching member, the first attaching member adapted to connect to the first container.

23. The connector of claim 22 wherein the first attaching member is integral with the first sleeve.

24. The connector of claim 22 wherein the first attaching member is a port adapter assembly.

25. The connector of claim 24 wherein the port adapter assembly has a port snap connected to a membrane tube, the port snap connected to the first sleeve, the membrane tube adapted to be connected to a port tube of the first container.

26. The connector of claim 25 wherein the membrane tube has a membrane pierceable by the piercing member when the connector is in the activated position.

27. The connector of claim 25 wherein the membrane tube is adapted to be solvent bonded to the port tube of the first container.

28. The connector of claim 25 wherein the membrane tube is solvent bonded to the port snap.

29. The connector of claim 25 further comprising a port septum positioned in the first sleeve proximate the port snap.

30. The connector of claim 29 wherein the first sleeve has a guide proximate a first end of the first sleeve, the port septum positioned between the guide and port snap.

31. The connector of claim 30 wherein the guide has a projection that indents the port septum.

32. The connector of claim 30 wherein the port snap has a finger that indents the port septum.

33. The connector of claim 25 wherein the first sleeve has a protrusion proximate a first end of the first sleeve, the port snap having flange, the port snap being snap fit into the first sleeve wherein the flange engages the protrusion.

34. The connector of claim 33 wherein the port snap is snap fit into the first sleeve within a low energy e-beam field.

35. The connector of claim 22 wherein the first attaching member is attached to the first sleeve within a low energy e-beam field.

36. The connector of claim 2 further comprising means for hermetically sealing the piercing member.

37. The connector of claim 1 wherein the second sleeve has a first end and a second end, and further comprising a sealing member positioned proximate the second end of the second sleeve.

38. The connector of claim 1 wherein the second sleeve has a second attaching member, the second attaching member being adapted to connect to the second container.

39. The connector of claim 38 wherein the second attaching member is integral with the second sleeve.

40. The connector of claim 38 wherein the second attaching member is a gripper assembly.

41. The connector of claim 40 wherein the gripper assembly comprises a base, a finger assembly extending from the base, and an annular wall circumjacent the finger assembly.

42. The connector of claim 41 wherein the finger assembly comprises a plurality of fingers.

43. The connector of claim 42 wherein a finger has a tab.

44. The connector of claim 42 wherein a finger has a standing rib.

45. The connector of claim 41 further comprising a septum positioned between the base and the finger assembly.

46. The connector of claim 45 wherein the septum has rubber collar contacting the base.

47. The connector of claim 41 further comprising a seal material over the annular wall.

48. The connector of claim 1 further comprising a finger assembly connected to a second end of the second sleeve, the finger assembly adapted to connect to the second container.

49. The connector of claim 48 wherein the finger assembly is sized to conform to dimensions of the second container.

50. The connector of claim 1 further comprising a septum positioned proximate a second end of the second sleeve.

51. The connector of claim 8 wherein when the sleeves move from the inactivated position to the activated position, a second end of the sleeve contacts the hub moving the piercing member towards a second end of the second sleeve.

52. The connector of claim 51 wherein the second sleeve has a protuberance, the hub moving past the protuberance in the activated position, the protuberance preventing movement of the hub when the sleeves are moved back to the inactivated position to define a deactivated position.

53. The connector of claim 1 wherein the second sleeve has first section and a second section defining an inner surface, the inner surface being tapered between the first section and the second section.

54. A reconstitution assembly comprising:

a flexible bag containing a diluent;

a drug vial containing a drug;

a reconstitution device further comprising;

a first sleeve connected to the first container;

a second sleeve connected to the second container, the second sleeve being associated with the first sleeve and movable axially with respect thereto from an inactivated position to an activated position;

a piercing member positioned in the sleeves, the piercing member providing a fluid pathway between the bag and vial when the sleeves are in the activated position.

55. The assembly of claim 54 further comprising means for preventing premature activation of the device.

56. The assembly of claim 54 wherein the first sleeve is connected to the flexible bag in a low energy e-beam field.

57. The assembly of claim 54 wherein the second sleeve is connected to the drug vial in a low energy e-beam field.

58. The assembly of claim 54 further comprising means for hermetically sealing the piercing member.

59. A locking device for use in connection with a medical connector for establishing fluid communication between a first container and a second container, the medical connecter including a first sleeve, a second sleeve and a piercing member for placing the first and second containers in fluid communication, the locking device comprising a means for preventing premature activation of the medical connector.

60. The device of claim 59 wherein the means for preventing premature activation comprises means for preventing movement of the first sleeve relative to the second sleeve.

61. The device of claim 59 wherein the means for preventing premature activation comprises a member adapted to be positioned on a sleeve.

62. The device of claim 61 wherein the member comprises a means for connecting the member to the sleeve and a means for locking the sleeve in an inactivated position.

63. The device of claim 62 wherein the connecting means is adapted to extend about a portion of the sleeve when the member is positioned on the sleeve.

64. The device of claim 63 wherein the connecting means further comprises extensions adapted to extend about a portion of an exterior surface of the sleeve when the member is positioned on the sleeve.

65. The device of claim 62 wherein the locking means comprises a member adapted to abut the other sleeve and a structure associated with the first container to restrict movement of the second sleeve with respect to the first sleeve.

66. The device of claim 62 wherein the connecting means and the locking means are integral.

67. The device of claim 60 wherein the means for preventing movement of the first sleeve relative to the second sleeve is a member adapted to be associated with the sleeves so as to maintain the sleeves in an essentially fixed relative position.

68. The device of claim 59 wherein the means for preventing premature activation comprises a clip adapted to be attached to the first sleeve, the clip having structure adapted to abut the second sleeve and a structure associated with the first container.

69. The device of claim 68 wherein the clip comprises a penannular cylinder that flexes to allow the clip to be removably connected to the first sleeve.

70. The device of claim 68 wherein the clip has a gripping device.

71. A locking device for use in connection with a medical connector for establishing fluid communication between a first container and a second container, the medical connecter including a first sleeve, a second sleeve and a piercing member for placing the first and second containers in fluid communication, the device comprising a member adapted to be removably positioned on the first sleeve and further adapted to be associated with the second sleeve so as to maintain the second sleeve in an essentially fixed position relative to the first sleeve.

72. A reconstitution device comprising:

a first sleeve having a first end and a second end;

a flexible bag connected to the first sleeve proximate to the first end;

a second sleeve having a first end and a second end, the second sleeve being associated with the first sleeve and is movable with respect thereto from an inactivated position to an activated position;

a second attaching member attached to the second sleeve member proximate the second end and adapted to receive a container; and

a piercing member positioned in the sleeves for providing a fluid pathway between the flexible bag and the container when in the activated position.

73. A reconstitution device comprising:

a first sleeve having a first end and a second end;

a flexible bag connected to the first sleeve proximate to the first end;

a second sleeve having a first end and a second end, the second sleeve being associated with the first sleeve and is movable with respect thereto from an inactivated position to an activated position;

a container joined to the second sleeve member proximate to the second end; and

a piercing member positioned in the sleeves and adapted to provide a fluid pathway between the flexible bag and the container when in the activated position.

74. A reconstitution assembly comprising:

a flexible bag containing a diluent;

a drug vial containing a drug;

a reconstitution device further comprising;

a first sleeve connected to the first container;

a second sleeve connected to the second container, the second sleeve being associated with the first sleeve and movable axially with respect thereto from an inactivated position to an activated position;

a piercing member positioned in the sleeves, the piercing member providing a fluid pathway between the bag and vial when the sleeves are in the activated position; and

means for preventing premature activation of the device.

75. A method of activating a connector device comprising the steps of:

providing a connector device having first and second sleeve members wherein the first sleeve member is attached to a first container and the second sleeve member is attached to a second container wherein the first container contains a fluid and the second container contains a drug;

positioning the second container on a hard surface;

applying a force to the connector device in the direction of the second container such that the first sleeve member of the connector device moves in the direction of the second container and places the connector device into an activated position.

76. The method of claim 75 wherein applying a force to the first sleeve comprises:

providing a grasping portion attached to the first sleeve; and

grasping the grasping portion and pushing it towards the second container.

77. The method of claim 75 wherein the force is applied vertically.

78. A method of activating a connector device comprising the steps of:

providing a connector device having first and second sleeve members wherein the first sleeve member is attached to a first container with a port connector having a flange and the second sleeve member is attached to a second container wherein the first container contains a fluid and the second container contains a drug;

positioning the second container on a hard surface;

applying a force to the flange in the direction of the second container such that the first sleeve member of the connector device moves in the direction of the second container and places the connector device into an activated position.

79. A method of manufacturing a connector device having a first sleeve member and a second sleeve member wherein the first and second sleeve members are associated such that the sleeves move rotationally and axially with respect to one another from an inactivated position to an activated position, wherein the first and second sleeve members are axially movable only when properly aligned, comprising the steps of:

providing a first sleeve member;

providing a second sleeve member;

assembling the first and second sleeve members into connector devices;

checking the alignment of the first and second sleeve members and approving those connector devices not having a proper alignment for activation;

rejecting those connector devices having a proper alignment for activation; and

changing the alignment of the rejected connector devices.

80. A connector device for establishing fluid communication between a first container and a second container comprising:

a sleeve assembly having a first end and a second end;

a first attaching member connected to the first end of the sleeve assembly and adapted to attach to the first container;

a second attaching member connected to the second end of the sleeve assembly and adapted to attach to the second container;

a piercing member positioned within the sleeve assembly, the piercing member having a first end and a second end and a fluid pathway for providing a fluid flow path from the first container to the second container;

the sleeve assembly movable from an inactivated position wherein the piercing member is adapted to not be fluid communication with the first container and the second container, to an activated position wherein the piercing member is adapted to be in fluid communication with the first container and the second container, wherein as the device is moved to the activated position, the second end of the piercing member is adapted to establish fluid communication with the second container before the first end of the piercing member is adapted to establish fluid communication with the first container.

81. A connector device for establishing fluid communication between a first container and a second container comprising:

a first sleeve having a first end and a second end;

a first attaching member connected to the first end of the first sleeve and adapted to attach to the first container;

a second sleeve having a first end and a second end, the second sleeve being slidably mounted to the first sleeve;

a second attaching member connected to the second end of the second sleeve and adapted to attach to the second container;

a piercing member positioned within the sleeves, the piercing member having a first end and a second end and a fluid pathway for providing a fluid flow path from the first container to the second container;

the sleeves being movable from an inactivated position wherein the piercing member is adapted to not be in fluid communication with the first container and the second container, to an activated position wherein the piercing member is adapted to be in fluid communication with the first container and the second container, wherein as the device is moved to the activated position, the second end of the piercing member is adapted to establish fluid communication with the second container before the first end of the piercing member is adapted to establish fluid communication with the first container.

82. A connector device for establishing fluid communication between a first container and a second container comprising:

a sleeve assembly having a first end and a second end;

a first attaching member connected to the first end of the sleeve assembly and adapted to attach to the first container;

a second attaching member connected to the second end of the sleeve assembly and adapted to attach to the second container;

a piercing member positioned within the sleeve assembly, the piercing member having a first end and a second end and a fluid pathway for providing a fluid flow path from the first container to the second container;

the sleeve assembly movable from an inactivated position wherein the piercing member is adapted to not be fluid communication with the first container and the second container, to an activated position wherein the piercing member is adapted to be in fluid communication with the first container and the second container, the sleeve assembly further being movable back from the activated position to the inactivated position wherein the device further has means adapted for maintaining the second end of the piercing member in fluid communication with the second container and wherein the piercing member is adapted to not be in fluid communication with the first container.

83. A connector device for establishing fluid communication between a first container and a second container comprising:

a sleeve assembly having a first end and a second end;

a first attaching member connected to the first end of the sleeve assembly and adapted to attach to the first container;

a second attaching member connected to the second end of the sleeve assembly and adapted to attach to the second container;

a piercing member positioned within the sleeve assembly, the piercing member having a first end and a second end and a fluid pathway for providing a fluid flow path from the first container to the second container;

the sleeve assembly movable from an inactivated position wherein the piercing member is adapted to not be fluid communication with the first container and the second container, to an activated position wherein the piercing member is adapted to be in fluid communication with the first container and the second container, the sleeve assembly further being movable to a deactivated position wherein the second end of the piercing member is adapted to be in fluid communication with the second container and wherein the first end of the piercing member is adapted to not be in fluid communication with the first container.

84. In a connector device having a piercing member for establishing fluid communication between a first container and a second container in a defined fluid pathway, a sealing system comprising a seal configuration that prevents fluid egress from the defined fluid pathway.

85. A connector device for establishing fluid communication between a first container and a second container comprising:

a first sleeve connected to a first container;

a second sleeve connected to a second container, the second sleeve being associated with the first sleeve;

a piercing member positioned in the sleeves, the piercing member having a fluid pathway for providing a fluid flow path between the first container and the second container;

a seal configuration associated with the sleeve, the sleeves being movable from an inactivated position wherein the piercing member is not in fluid communication with the first container and the second container, to an activated position wherein the piercing member is in fluid communication with the first container and the second container, wherein when the device is in the activated position, the seal configuration defining a sealed fluid pathway around the piercing member capable or resisting pressure created from compressing the first container.

86. A reconstitution assembly comprising:

a flexible bag defining an interior containing a diluent, the flexible bag having a port tube in communication with the interior

a drug vial containing a drug, the drug vial having a closure;

a reconstitution device comprising;

a first sleeve having a first end and a second end, the first end connected to a port adapter assembly defining a seal, the port adapter assembly connected to the port tube defining a seal;

a second sleeve having a first end and a second end, the second sleeve being slidably mounted to the first sleeve, the second sleeve having a gripper assembly at the second end, the gripper assembly connected to the drug vial;

a piercing assembly positioned within the sleeves, the piercing assembly having a first piercing member connected to a second piercing member defining a seal therebetween, the piercing members collectively defining a fluid pathway for providing a fluid flow path from the first container to the second container;

the sleeves being movable from an inactivated position wherein the piercing members are not in fluid communication with the first container and the second container, to an activated position wherein the piercing members are adapted to be in fluid communication with the first container and the second container, wherein when the device is in the activated position, the plurality of seals provide a sealed fluid pathway and are capable of resisting pressure created in the fluid pathway from compressing the flexible bag to maintain the sealed fluid pathway.

87. A container subassembly for attachment to a reconstitution device having a sleeve having an end, the container subassembly comprising:

a flexible container defining an interior in communication with a port tube;

a membrane tube connected to the port tube;

a port snap connected to the port tube, the port snap having an attaching member adapted to attach to the sleeve.