Sliding reconstitution device for a diluent container
First Claim
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.
1 Assignment
0 Petitions
Accused Products
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).
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Citations
87 Claims
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1. A connector for establishing fluid communication between a first container and a second container comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53)
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54. A reconstitution assembly comprising:
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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. - View Dependent Claims (55, 56, 57, 58)
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- 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.
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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.
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72. A reconstitution device comprising:
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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.
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73. A reconstitution device comprising:
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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.
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74. A reconstitution assembly comprising:
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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.
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75. A method of activating a connector device comprising the steps of:
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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. - View Dependent Claims (76, 77)
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78. A method of activating a connector device comprising the steps of:
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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.
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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:
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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.
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80. A connector device for establishing fluid communication between a first container and a second container comprising:
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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.
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81. A connector device for establishing fluid communication between a first container and a second container comprising:
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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.
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82. A connector device for establishing fluid communication between a first container and a second container comprising:
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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.
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83. A connector device for establishing fluid communication between a first container and a second container comprising:
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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.
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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.
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85. A connector device for establishing fluid communication between a first container and a second container comprising:
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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.
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86. A reconstitution assembly comprising:
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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.
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87. A container subassembly for attachment to a reconstitution device having a sleeve having an end, the container subassembly comprising:
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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.
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Specification