CA2478387A1 - Sliding reconstitution device for a diluent container - Google Patents

Sliding reconstitution device for a diluent container Download PDF

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Publication number
CA2478387A1
CA2478387A1 CA 2478387 CA2478387A CA2478387A1 CA 2478387 A1 CA2478387 A1 CA 2478387A1 CA 2478387 CA2478387 CA 2478387 CA 2478387 A CA2478387 A CA 2478387A CA 2478387 A1 CA2478387 A1 CA 2478387A1
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CA
Canada
Prior art keywords
closure
septum
container
annular
connector
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.)
Granted
Application number
CA 2478387
Other languages
French (fr)
Other versions
CA2478387C (en
Inventor
Thomas A. Fowles
Robert J. Weinberg
Thomas J. Progar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter International Inc.
Thomas A. Fowles
Robert J. Weinberg
Thomas J. Progar
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Filing date
Publication date
Application filed by Baxter International Inc., Thomas A. Fowles, Robert J. Weinberg, Thomas J. Progar filed Critical Baxter International Inc.
Publication of CA2478387A1 publication Critical patent/CA2478387A1/en
Application granted granted Critical
Publication of CA2478387C publication Critical patent/CA2478387C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • A61J1/1475—Inlet or outlet ports
    • 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
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
    • 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

The present invention provides a reconstitution device (10) for placing a first container (12), such a liquid container (e.g. flexible container or syringe), in fluid communication with a second container (14), such as a drug vial. To this end, there is provided a connector device (10) for establishing fluid communication between the diluent container (12) and the drug vial (14).
The connector device (10) has a first sleeve member (32) having a first end (36) and a second end (38). The first sleeve member (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 member (34) having a first end (48) and a second end (50). The second sleeve member (34) is movable axially with respect to the first sleeve member (32) from an inactivated position to an activated position. The second sleeve member (34) has a protuberance (66) on an inner surface of the second sleeve member (34). A
second attaching member (28) is attached on the second end (50) of the second sleeve member (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) is positioned in the chamber and projects within the sleeve members (32, 34) for providing a fluid flow path from the first container (12) to the second container (14). The piercing member (76) is moveable from a first position in the inactivated position to a second position in the activated position wherein the piercing member (76) moves past the protuberance (66), the protuberance (66) preventing movement of the piercing member (76) back to the first position. The device (10) is movable from the inactivated position to the activated position by a force gnerally applied to the device outside the liquid container (12).

Claims (97)

1. 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 and a sidewall, the sidewall having an inner surface and a protuberance on the inner surface;
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 for providing a fluid flow path from the first container to the second container, the piercing member moveable from a first position in the inactivated position to a second position in the activated position wherein the piercing member moves past the protuberance, the protuberance preventing movement of the piercing member back to the first position.
2. The device of claim 1 wherein the sleeve assembly comprises a first sleeve and a second sleeve mounted for translational motion with respect to one another, the first sleeve being connected to the first attaching member and the second sleeve being connected to the second attaching member, the protuberance positioned on the inner surface of the sidewall of the second sleeve.
3. The device of claim 1 wherein the sleeve assembly has a protrusion on the inner surface at the first end, the first attaching member comprises a port connector having a port snap connected to a port sleeve, the port snap having a flange extending from an outer surface, the port connector being connected to the first end of the sleeve assembly wherein the flange engages the protrusion, the port sleeve adapted to attach to the first container.
4. The device of claim 3 wherein the port sleeve has a membrane at one end.
5. The device of claim 3 further comprising a sealing member positioned at the first end of the sleeve assembly adjacent the port snap.
6. The device of claim 1 wherein the second attaching member comprises a gripper assembly attached to the second end of the sleeve assembly, the gripper assembly having a base and an annular wall portion extending from the base and a plurality of fingers circumjacent the wall portion, the fingers being circumferentially spaced defining a vial receiving chamber adapted to receive the vial, wherein one finger has a tab adapted to engage an underside of the neck and one finger has a standing rib adapted to engage a side portion of the vial closure.
7. The device of claim 6 wherein the gripper assembly further has a first annular rim extending from the base and a second annular rim extending collectively from the fingers and in spaced relation to the first annular rim.
8. The device of claim 7 further comprising a septum having a disk having opposing first and second surfaces, the first surface having a first annular groove receiving the first annular rim, the second surface having a second annular groove receiving the second annular rim.
9. The device of claim 8 wherein the second surface of the septum further has an annular ridge having a sidewall tapering axially-outwardly, so that the annular ridge is capable of forming a fluid tight seal with the vial when the vial is received by the fingers of the gripper assembly.
10. The device of claim 8 wherein the disk has a center hub having a generally thickened cross-section.
11. The device of claim 6 wherein the wall portion has a lip at a peripheral end, the device further comprising an end cap releasably secured to the gripper assembly and cooperating with the lip.
12. The connector device of claim 1 wherein the piercing member has a first end and a second end and further comprising means for independently hermetically sealing the first and second ends of the piercing member.
13. The device of claim 1 further comprising a septum positioned over the second end of the sleeve assembly, the septum having a center hub having a generally thickened cross-section.
14. The device of claim 1 further comprising a tamper evident strip positioned around the sleeve assembly.
15. The device of claim 1 wherein the sleeve assembly is movable from the inactivated position to the activated position by a force generally applied to the device outside the first container.
16. A connector device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member having a first end and a second end;
a first attaching member on the first end of the first sleeve member and adapted to attach to the first container;
a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and is movable axially with respect thereto from an inactivated position to an activated position, the second sleeve member having a protuberance on an inner surface of the second sleeve member;
a second attaching member on the second end of the second sleeve and adapted to attach the second sleeve member to the second container;
a piercing member positioned within the second sleeve member for providing a fluid flow path between the first container and the second container, the piercing member moveable from a first position in the inactivated position to a second position in the activated position wherein the piercing member moves past the protuberance, the protuberance preventing movement of the piercing member back to the first position.
17. A connector device for establishing fluid communication between a liquid container and a vial having a neck with a closure therein, the connector comprising:
a first sleeve member having a first end and a second end and an inner surface, the first sleeve member having a protrusion on the inner surface at the first end;
a port connector having a port snap connected to a port sleeve, the port snap having a flange extending from an outer surface, the port connector being connected to the first sleeve member wherein the flange engages the protrusion, the port sleeve adapted to attach to the liquid container, the port sleeve having a membrane at one end;
a sealing member positioned at the first end of the first sleeve adjacent the port snap;
a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and is movable axially with respect thereto from an inactivated position to an activated position, the second sleeve member having a protuberance on an inner surface of the second sleeve member;
a sleeve sealing member positioned between an outer surface of the first sleeve member and an inner surface of the second sleeve member;
a gripper assembly attached to the second end of the second sleeve, the gripper assembly having a base and an annular wall portion extending from the base and a plurality of fingers circumjacent the wall portion, the fingers being circumferentially spaced defining a vial receiving chamber adapted to receive the vial, wherein one finger has a tab adapted to engage an underside of the neck and one finger has a standing rib adapted to engage a side portion of the vial closure, and a first annular rim extending from the base and a second annular rim extending collectively from the fingers and in spaced relation to the first annular rim, the wall portion having a lip at a peripheral end;
an end cap releasably secured to the gripper assembly and cooperating with the lip;
a septum having a disk having opposing first and second surfaces, the disk having a center hub having a generally thickened cross-section, the first surface having a first annular groove receiving the first annular rim, the second surface having a second annular groove receiving the second annular rim, the second surface further having an annular ridge having a sidewall tapering axially-outwardly, so that the annular ridge is capable of forming a fluid tight seal with the vial when the vial is received by the fingers of the gripper assembly; and a piercing member positioned within the sleeve members, the piercing member having a hub supporting a first piercing member and a second piercing member for providing a fluid flow path between the liquid container and the vial, the piercing member moveable from a first position in the inactivated position to a second position in the activated position wherein the hub moves past the protuberance, the protuberance preventing movement of the piercing member back to the first position.
18. A connector device for establishing fluid communication between a liquid container and a drug vial having a neck with a closure therein, the connector comprising:
a piercing member having a first end and a second end and a central fluid pathway;
a vial receiving chamber associated with the piercing member and being dimensioned to connect to the vial;
means for connecting the vial receiving chamber to the liquid container;
wherein the device is movable from an inactivated position where the piercing member is outside the sidewalls and no fluid flows between the liquid container and the drug vial, to an activated position wherein fluid flows through the fluid pathway between the liquid container and the drug vial, the device being movable from the inactivated position to the activated position by a force applied to the device outside the liquid container; and a tamper evident strip associated with the device for indicating when the device has been moved from the inactivated position to the activated position.
19. A connector device for establishing fluid communication between a liquid container having sidewalls and a vial having a neck with a closure therein, the connector comprising:
a piercing member having a first end and a second end and a central fluid pathway;
a vial receiving chamber associated with the piercing member and being dimensioned to connect to the vial;
means for connecting the vial receiving chamber to the liquid container, the means defining a central passageway;
a hub mounting the piercing member within the means for connecting the vial receiving chamber to the liquid container;

a protuberance attached to the means for connecting the vial receiving chamber to the liquid container and dimensioned for allowing movement of the hub past the protuberance in one direction only; and wherein the device is movable from an inactivated position where no fluid flows between the liquid container and the drug vial, to an activated position wherein the hub is moved past the protuberance and fluid flows through the fluid pathway between the liquid container and the drug vial, the device being movable from the inactivated position to the activated position by a force applied to the device outside the liquid container.
20. A connector device for establishing fluid communication between a liquid container having sidewalls and a vial having a neck with a closure therein, the connector comprising:
a piercing member having a first end and a second end and a central fluid pathway;
a vial receiving chamber associated with the piercing member and being dimensioned to connect to the vial;
means for connecting the vial receiving chamber to the liquid container;
wherein the device is movable from an inactivated position where the piercing member is outside the sidewalls and no fluid flows between the liquid container and the drug vial, to an activated position wherein fluid flows through the fluid pathway between the liquid container and the drug vial, the device being movable from the inactivated position to the activated position by a force applied to the device outside the liquid container; and a sealing member having a thickened center hub which substantially blocks the central fluid passageway of the piercing member as the center hub is penetrated by the piercing member but before the piercing member completely penetrates the piercing center hub.
21. A connector device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member having a first end and a second end and a sidewall defining a chamber, the first sleeve member having a protrusion on an inner surface at the first end;
a port connector having a port snap connected to a port sleeve, the port snap having a flange extending from an outer surface, the port connector being connected to the first sleeve member wherein the flange engages the protrusion, the port sleeve adapted to attach to the first container;
a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and is movable axially with respect thereto from an inactivated position to an activated position;
a second attaching member on the second end of the second sleeve and adapted to attach the second sleeve member to the second container; and a piercing member positioned in the chamber and projecting from one of the first and second sleeve members for providing a fluid flow path between the first container and the second container.
22. The device of claim 21 wherein the poet sleeve has a membrane at one end.
23. A connector device for establishing fluid communication between a first container and a second container comprising:
a first sleeve member having a first end and a second end and a sidewall defining a chamber, a first attaching member on the first end of the first sleeve member and adapted to attach to the first container;
a second sleeve member having a first end and a second end, the second sleeve member being associated with the first sleeve member and is movable axially with respect thereto from an inactivated position to an activated position;
a gripper assembly attached to the second end of the second sleeve, the gripper assembly having a base and an annular wall portion extending from the base and a plurality of fingers circumjacent the wall portion, the fingers being circumferentially spaced defining a vial receiving chamber adapted to receive the vial, and a first annular rim extending from the base and a second annular rim extending collectively from the fingers and in spaced relation to the first annular rim;
a septum having a disk having opposing first and second surfaces, the first surface having a first annular groove receiving the first annular rim, the second surface having a second annular groove receiving the second annular rim; and a piercing member positioned in the chamber and projecting from one of the first and second sleeve members for providing a fluid flow path from the first container to the second container.
24. A septum for a medical connector, wherein the connector has a gripper assembly to attach to a closure of a container, the closure of the container having a target site, the gripper assembly having a first annular rim and a second annular rim, wherein the second annular rim is coradial with the first annular rim and longitudinally displaced therefrom, the septum comprising:
a disk having opposing first and second surfaces, the first surface having a first annular groove adapted to receive the first annular rim, the second surface having a second annular groove adapted to receive the second annular rim.
25. The septum of claim 24 wherein the septum further comprises a center hub having a generally thickened cross-section.
26. The septum of claim 24 wherein the septum further comprises an annular ridge extending from the second surface of the disk, the annular ridge having a sidewall wherein a portion of the sidewall tapers axially-outward, so that the annular ridge is capable of forming a fluid tight seal with the target site of the closure.
27. The septum of claim 26 wherein the annular ridge is capable of folding radially-outward to account for dimensional differences in a height of the closure.
28. A septum for a medical connector, wherein the connector has a gripper assembly to attach to a closure of a container, the closure of the container having a target site, the gripper assembly having a first annular rim and a second annular rim confronting in spaced relation the first annular rim, the septum comprising:
a disk having opposing first and second surfaces, the first surface having a first annular groove adapted to receive the first annular rim, the second surface having a second annular groove adapted to receive the second annular rim, the disk further having a center hub having a generally thickened cross-section, and further having an annular ridge extending from the second surface, the annular ridge having a sidewall wherein a portion of the sidewall tapers axially-outward, so that the annular ridge is capable of forming a fluid tight seal with the target site of the closure.
29. A device for connecting to a vial having a closure, the closure having a target site, the device comprising:
a finger assembly defining a receiving chamber dimensioned to accommodate the closure of the vial, the finger assembly having a panel having a first side and a second side;
an annular ring extending from the second side of the panel, the annular ring having a center opening therethrough, the annular ring capable of forming a fluid tight seal against the target site of the closure.
30. The device of claim 29 further comprising a septum positioned adjacent a bottom portion of the finger assembly, the septum having a center plug positioned within the center opening.
31. The device of claim 29 wherein the annular ring has a rounded end surface.
32. The device of claim 29 wherein the annular ring is made of a polymeric material.
33. The device of claim 29 further comprising an annular wall circumjacent the finger assembly.
34. A device for connecting to a vial having a closure, the closure having a target site, the device comprising:
a base;
an annular wall connected to the base;
a finger assembly connected to the annular wall, the finger assembly defining a receiving chamber adapted to accommodate the closure of the vial, the finger assembly having a panel adjacent the space wherein a space is maintained between the panel and the base, the panel having a first side and a second side;
an annular ring extending from the second side of the panel, the annular ring defining a center opening therethrough, the annular ring capable of forming a fluid tight seal against the target site of the closure;
a sealing member positioned in the space, the sealing member having a center plug positioned within the center opening.
35. A septum for a medical connector, wherein the connector has an end to attach to a closure of a container, the closure of the container having a target site, the connector further having a piercing member therein for piercing the target site of the closure, the septum comprising:
a disk having opposing first and second surfaces, the disk further having a center portion;
a rigid annular ring supported by the center portion of the disk and extending from the second surface of the disk, the annular ring being capable of forming a fluid tight seal with the target site of the closure.
36. A septum for a medical connector, wherein the connector has an end to attach to a closure of a container, the closure of the container having a target site, the connector further having a piercing member therein for piercing the target site of the closure, the septum comprising:
a disk having opposing first and second surfaces;
an annular ridge extending from the second surface of the disk, the annular ridge being capable of forming a fluid tight seal with the target site of the closure; and a cap extending from the second surface of the disk, the cap being positioned within the annular ridge, the cap capable of forming a fluid tight seal with the target site of the closure.
37. The septum of claim 36 wherein the cap has a frustoconical sidewall connected to a top wall.
38. The septum of claim 37 wherein the top wall has a concave shape.
39. The septum of claim 36 wherein the first surface has a recessed portion.
40. The septum of claim 37 wherein the frustoconical sidewall is adapted to bow outwardly when the container closure is positioned against the septum.
41. The septum of claim 37 wherein the frustoconical sidewall is adapted to move axially towards the first surface and fold upon itself when the container closure is positioned against the septum.
42. The septum of claim 38 wherein the top wall is adapted to move from a generally concave shape to a generally planar shape when the container closure is positioned against the septum.
43. The septum of claim 36 wherein the annular ridge has a sidewall wherein a portion of the sidewall tapers axially-outward.
44. The septum of claim 36 wherein the cap is a conical frustum.
45. A septum for a medical connector, wherein the connector has an end to attach to a container, the container having a closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a base having opposing first and second surfaces;
a diaphragm extending from the second surface of the disk, the diaphragm capable of forming a fluid tight seal with the closure;
an annular ridge extending from the second surface of the disk and being circumjacent the diaphragm, the annular ridge capable of forming a second fluid tight seal with the closure.
46. The septum of claim 45 wherein the diaphragm has an annular wall.
47. The septum of claim 46 wherein when the container is connected to the connector, the diaphragm is adapted to abut the closure and the annular wall folds upon itself.
48. The septum of claim 46 wherein when the container is connected to the connector, the diaphragm is adapted to abut the closure and the annular wall bows outwardly.
49. The septum of claim 45 wherein the diaphragm has a membrane that is adapted to confront the closure.
50. The septum of claim 49 wherein the container has a crimp ring positioned over the closure, the crimp ring having an opening defining a target site on the closure, wherein when the container is connected to the connector a space is maintained between the crimp ring and the membrane.
51. The septum of claim 46 wherein the container has a crimp ring positioned over the closure, the crimp ring having an opening defining a target site on the closure, wherein when the container is connected to the connector a space is maintained between the crimp ring and the annular wall.
52. The septum of claim 49 wherein the membrane has a convex surface confronting the closure in a first position, and when the container is connected to the connector the surface is planar in a second position.
53. The septum of claim 52 wherein the surface contacts the closure in the second position.
54. The septum of claim 46 wherein the annular wall has a lip.
55. The septum of claim 52 wherein the lip has a protrusion.
56. The septum of claim 53 wherein the protrusion is rounded.
57. The septum of claim 54 wherein the lip is adapted to abut the closure.
58. The septum of claim 56 wherein the rounded protrusion is adapted to abut the closure.
59. The septum of claim 45 wherein the diaphragm has an annular wall connected to a membrane.
60. The septum of claim 45 wherein the diaphragm extends from the second surface at a first length, and wherein the annular ridge extends from the second surface at a second length, the second length being less than the first length.
61. The septum of claim 45 wherein the diaphragm is frustoconical.
62. The septum of claim 61 wherein when the container is connected to the connector, the diaphragm is adapted to abut the closure and fold upon itself.
63. The septum of claim 61 wherein when the container is connected to the connector, the diaphragm is adapted to abut the closure and bow outwardly.
64. The septum of claim 45 wherein the annular ridge has a sidewall wherein a portion of the sidewall tapers axially-outward, so that the annular ridge is capable of forming the second fluid tight seal with the closure.
65. The septum of claim 45 wherein the diaphragm is capable of flexing to account for dimensional differences in a height of the closure.
66. The septum of claim 45 wherein the annular ridge is capable of flexing to account for dimensional differences in a height of the closure.
67. The septum of claim 45 wherein the annular ridge is capable of folding radially-outward to account for dimensional differences in a height of the closure.
68. The septum of claim 64 wherein the sidewall tapers axially-outward from a proximal end to a distal end.
69. A septum for a medical connector, wherein the connector has an end to attach to a closure of container, the container having a crimp ring positioned over the closure, the crimp ring having an opening defining a target site on the closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a disk having opposing first and second surfaces;
a diaphragm extending from the second surface of the disk;
an annular ridge extending from the second surface of the disk and being circumjacent the diaphragm;
wherein when the container is connected to the connector, the diaphragm is adapted to form a first fluid tight seal with the target site and the annular ridge is adapted to form a second fluid tight seal with the crimp ring.
70. A septum for a medical connector, wherein the connector has an end to attach to a closure of container, the container having a crimp ring positioned over the closure, the crimp ring having an opening defining a target site on the closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a disk having opposing first and second surfaces;
a diaphragm extending from the second surface of the disk, the diaphragm being frustoconical.
an annular ridge extending from the second surface of the disk, the annular ridge being circumjacent the diaphragm, wherein the annular ridge has a sidewall wherein a portion of the sidewall tapers axially-outward, wherein when the container is connected to the connector, the diaphragm is adapted to abut the target site of the closure and fold upon itself wherein a first fluid tight seal is formed with the target site, and wherein the sidewall is adapted to abut the crimp ring wherein a second fluid tight seal is formed with the crimp ring.
71. A septum for a medical connector, wherein the connector has an end to attach to a container, the container having a closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a base having opposing first and second surfaces, the base having a means for dual-sealing against the closure of the container.
72. A septum for a medical connector, wherein the connector has an end to attach to a closure of container, the container having a crimp ring positioned over the closure, the crimp ring having an opening defining a target site on the closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a disk having opposing first and second surfaces;
a rolling diaphragm extending from the second surface of the disk at a first length, the diaphragm having an annular wall connected to a membrane;
an annular ridge extending from the second surface of the disk at a second length, the second length being less than the first length, the annular ridge being circumjacent the diaphragm, wherein the annular ridge has a sidewall wherein a portion of the sidewall tapers axially-outward, wherein when the container is connected to the connector, the diaphragm membrane is adapted to abut the target site of the closure and wherein the diaphragm annular wall rolls to folds upon itself wherein a first fluid tight seal is formed with the target site and wherein the membrane and annular wall do not contact the crimp ring, and wherein the annular ridge sidewall is adapted to abut the crimp ring wherein a second fluid tight seal is formed with the crimp ring.
73. A septum for a medical connector, wherein the connector has an end to attach to a container, the container having a closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a base having opposing first and second surfaces:

a rigid annular ring extending from the second surface of the disk, the rigid annular ring capable of forming a fluid tight seal with the closure.
74. The septum of claim 73 wherein the rigid annular ring defines a center opening wherein a membrane is positioned in the center opening.
75. The septum of claim 74 wherein the membrane is spaced from the base.
76. The septum of claim 74 wherein the membrane is adapted to be spaced from the closure.
77. The septum of claim 73 wherein the rigid annular ring has a protrusion at a distal end.
78. The septum of claim 77 wherein the protrusion is tapered to a rounded end.
79. The septum of claim 73 further comprising a plurality of spokes extending from the annular ring along the base.
80. The septum of claim 73 wherein the first surface has a first annular groove and the second surface has a second annular groove.
81. A septum for a medical connector, wherein the connector has an end to attach to a closure of a container, the container having a crimp ring positioned over the closure, the crimp ring having an opening defining a target site on the closure, the septum comprising:
a base having opposing first and second surfaces:
a rigid annular ring extending from the second surface of the disk, the rigid annular ring capable of forming a fluid tight seal with the target site on the closure, the ring adapted to be spaced inwardly from the crimp ring.
82. A septum for a medical connector, wherein the connector has an end to attach to a closure of a container, the container having a crimp ring positioned over the closure, the crimp ring having an opening defining a target site on the closure, the septum comprising:
a base having opposing first and second surfaces:
a rigid annular ring extending from the second surface of the disk, the rigid annular ring having a rounded distal end capable of forming a fluid tight seal with the target site on the closure, the ring adapted to be spaced inwardly from the crimp ring, wherein the rigid annular ring defines a center opening wherein a membrane is positioned in the center opening and is spaced from the base.
83. A septum for a medical connector, wherein the connector has an end to attach to a container, the container having a closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a rigid plastic base having opposing first and second surfaces, the base having an opening; and a rubber membrane positioned in the opening and adapted to be positioned adjacent the closure, wherein the base and membrane are formed simultaneously in a two-shot injection molded process.
84. The septum of claim 83 further comprising a flexible collar connected to a peripheral edge of the base, wherein the collar is formed in the injection molded process.
85. The septum of claim 84 wherein the collar has an inner peripheral groove and the base has an outer peripheral tongue, the tongue being received by the groove.
86. The septum of claim 84 wherein the base and collar are generally circular.
87. The septum of claim 84 wherein the collar has opposing first and second surfaces, the first surface having a first annular groove and the second surface having a annular groove.
88. The septum of claim 83 wherein the first side of the base has a recessed portion.
89. The septum of claim 83 wherein the rubber membrane has a generally planar section having a leg depending therefrom, the leg connected to an inner surface defined by the opening.
90. The septum of claim 83 wherein the opening is substantially at a center of the base.
91. The septum of claim 83 wherein the base is capable of forming a fluid tight seal with the closure.
92. The septum of claim 83 wherein the base has an annular ring extending from the second surface of the base, the annular ring capable of forming a fluid tight seal with the closure.
93. The septum of claim 92 wherein the annular ring has a rounded distal end.
94. A septum for a medical connector, wherein the connector has an end to attach to a container, the container having a closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a rigid plastic base having opposing first and second surfaces, the base having an annular ring extending from the second surface of the dish, the annular ring capable of forming a fluid tight seal with the closure, the ring defining a center opening;
a rubber membrane positioned in the center opening and connected to the annular ring, wherein the base and rubber membrane are formed simultaneously in a two-shot injection molded process.
95. A septum for a medical connector, wherein the connector has an end to attach to a container, the container having a closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:

a rigid plastic disk having opposing first and second surfaces and a peripheral edge defining a tongue, the base having an annular ring extending from the second surface of the disk, the annular ring having a rounded distal end capable of forming a fluid tight seal with the closure, the ring defining a center opening;
a rubber membrane positioned in the center opening and connected to the annular ring;
a rubber collar having an inner peripheral groove that receives the tongue, the rubber collar having opposed first and second surfaces, the first surface having a first annular groove and the second surface having a second annular groove, wherein the base, rubber membrane and rubber collar are formed simultaneously in a two-shot injection molded process.
96. A septum for a medical connector, wherein the connector has an end to attach to a container, the container having a closure, the connector further having a piercing member therein for piercing the closure, the septum comprising:
a rigid plastic base having opposing first and second surfaces, the base having an opening; and a rubber membrane positioned in the opening and adapted to be positioned adjacent the closure, wherein the base and membrane are formed in an insert-molding process.
97. The device of claim 1 wherein the sleeve assembly has a projection that maintains the piercing member in the first position when the device is in the inactivated position.
CA 2478387 2002-03-26 2003-03-26 Sliding reconstitution device for a diluent container Expired - Fee Related CA2478387C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/106,716 US7074216B2 (en) 1998-09-15 2002-03-26 Sliding reconstitution device for a diluent container
US10/106,716 2002-03-26
PCT/US2003/009190 WO2003082398A2 (en) 2002-03-26 2003-03-26 Sliding reconstitution device for a diluent container

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CA2478387A1 true CA2478387A1 (en) 2003-10-09
CA2478387C CA2478387C (en) 2011-01-04

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EP (2) EP1487533B1 (en)
JP (2) JP4454315B2 (en)
KR (1) KR20040111430A (en)
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AR (1) AR039128A1 (en)
AT (1) ATE435048T1 (en)
AU (2) AU2003226002B2 (en)
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DE (1) DE60328171D1 (en)
DK (1) DK1487533T3 (en)
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