DRUG STORAGE AND DELIVERY DEVICE

• US 20090216184A1
• Filed: 02/26/2007
• Published: 08/27/2009
• Est. Priority Date: 03/07/2006
• Status: Abandoned Application

• Current Assignee: Novo Nordisk Health Care AG (Novo Nordisk A/S)
• Original Assignee: Novo Nordisk A/S
• Inventors: Radmer, Bo, Nielsen, Per Valentin, Revsgaard, Morten, Larsen, Poul, Sie, Gunner
• Application Number:
  US12/281,533
• Publication Number:
  US 20090216184A1
• Time in Patent Office: Days
• US Class Current: 604/86
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2017 having three or more 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 1/2065 having aligning and guiding 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: A61M 2005/3117 Means preventing contamination of the medicament compartment of a syringe
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing

Abstract

A drug storage and delivery device (1) comprising a reservoir (2) containing a liquid, a vial (3) containing a dry drug, such as a lyophilized drug, means (6) for forcing the liquid from the reservoir (2) to the vial (3), via an established fluid connection, and locking means adapted to prevent the means (6) for establishing a fluid connection from re-establishing a previously disconnected fluid connection between the reservoir and the vial. Thereby the dry drug is reconstituted, and the forcing means (6) may subsequently be used for forcing reconstituted drug out of the device (1). The reservoir (2), the vial (3), the fluid connection and the forcing means (6) may form an at least substantially integral unit. This is an advantage because the number of steps needed to be performed by the user is reduced, the risk of contamination is reduced, the risk of incorrect reconstitution and dosage is reduced, and the device is easy to operate, e.g. using just one hand.

Claims

1. A drug storage and delivery device comprising:

a reservoir containing a liquid,

a vial containing a dry drug,

means for establishing a fluid connection between the reservoir and the vial,

first forcing means for forcing the liquid from the reservoir to the vial, via an established fluid connection, thereby causing the dry drug to become reconstituted, and

locking means adapted to prevent the means for establishing a fluid connection from re-establishing a previously disconnected fluid connection between the reservoir and the vial.

2. A device according to claim 1, wherein the reservoir, the vial, the means for establishing a fluid connection and the first forcing means form an at least substantially integral unit.

3. A device according to claim 1, further comprising releasable locking means adapted to be in a locked and an unlocked position, wherein the releasable locking means, when in its locked position, is adapted to lock the device in a position in which a fluid connection is established between the reservoir and the vial, and in which the first forcing means is forcing liquid from the reservoir to the vial.

4. A device according to claim 3, wherein the releasable locking means is adapted to be moved from the unlocked position to the locked position by pushing the releasable locking means in a specific direction, and wherein the releasable locking means is adapted to be moved from the locked to the unlocked position by pushing the releasable locking means in the specific direction, thereby releasing the releasable locking means.

5. A device according to claim 3, wherein the releasable locking means, when in its unlocked position, is adapted to allow a flow of reconstituted drug to flow from the vial to the reservoir.

6. A device according to claim 1, wherein the means for establishing a fluid connection comprises at least a first spike adapted to penetrate the vial.

7. A device according to claim 1, wherein the means for establishing a fluid connection comprises at least a second spike adapted to penetrate the reservoir.

8. A device according to claim 1, wherein the means for establishing a fluid connection is arranged inside a closed compartment which is held under sterile conditions.

9. A device according to claim 8, wherein the closed compartment is delimited at one end by a septum of the vial and at another end by a part of the reservoir.

10. A device according to claim 1, further comprising means for delivering a reconstituted drug from the device.

11. A device according to claim 10, wherein the delivering means comprises second forcing means adapted to force a reconstituted drug towards an outlet opening for delivery of the reconstituted drug.

12. A device according to claim 11, wherein the second forcing means is or forms part of the first forcing means.

13. A device according to claim 10, wherein the delivering means comprises means for establishing a fluid connection between a part of the device containing reconstituted drug and an outlet opening.

14. A device according to claim 13, wherein the means for establishing a fluid connection to the outlet opening is adapted to be in a first state in which it is not possible to establish said fluid connection and a second state in which it is possible to establish said fluid connection, and wherein the means for establishing said fluid connection is adapted to be in the first state during reconstitution of the dry drug and is adapted to be moved to the second state when the reconstituted drug is ready to be delivered.

15. A device according to claim 14, wherein the means for establishing a fluid connection to the outlet opening is adapted to be automatically moved from the first state to the second state when the reconstituted drug is ready to be delivered.

16. A device according to claim 13, wherein the means for establishing a fluid connection to the outlet opening comprises a third spike adapted to penetrate a septum arranged at or near the outlet opening.

17. A device according to claim 1, wherein the first forcing means comprises a movable plunger positioned in the reservoir.

18. A device according to claim 1, the device comprising:

at least one reservoir containing a liquid,

at least two vials, each containing a dry drug, and

means for establishing one or more fluid connections between the reservoir(s) and the vials, thereby causing the dry drug of each of the vials to become reconstituted.

19. A device according to claim 18, further comprising means for retrieving reconstituted drug from each of the vials.

20. A device according to claim 1, further comprising means for equalising a pressure build up in the reservoir.

21. A device for establishing a fluid connection between two containers, the device comprising:

a first spike adapted to penetrate a septum of a first container,

a second spike adapted to penetrate a septum of a second container, the first and second spikes being interconnected in such a manner that a fluid connection is established between the first and second containers when the first spike penetrates the septum of the first container and the second spike penetrates the septum of the second container, and

a locking mechanism for locking said spikes in such a manner that re-establishing a previously disconnected fluid connection is prevented.

22. A device according to claim 21, wherein the locking mechanism is releasable.

23. A method of operating a drug storage and delivery device comprising a reservoir containing a liquid, a vial containing a dry drug and means for establishing a fluid connection between the reservoir and the vial, the method comprising the:

moving the reservoir containing a liquid and the vial containing a dry drug towards each other, thereby establishing a fluid connection between the reservoir and the vial,

forcing liquid from the reservoir into the vial, thereby causing the dry drug to become reconstituted,

locking the means for establishing a fluid connection in a position where a fluid connection is established and liquid is being forced from the reservoir to the vial,

unlocking the means for establishing a fluid connection, thereby allowing reconstituted drug to return to the reservoir, and

locking the means for establishing a fluid connection in a position where a fluid connection is disconnected, thereby preventing re-establishing the fluid connection.

24. A method according to claim 23, further comprising the:

locking an outlet opening of the drug storage and delivery device, thereby preventing drug from being delivered from the device, and

unlocking the outlet opening after the reconstituted drug has returned to the reservoir, thereby allowing the reconstituted drug to be delivered from the device.

25. A method according to claim 24, wherein the step of unlocking the outlet opening is performed automatically.

26. A method according to claim 25, further comprising the step of automatically performing aspiration via the outlet opening upon unlocking the outlet opening.

27. A method according to claim 23, further comprising the step of equalizing a pressure in the reservoir.

28. A drug storage and delivery device comprising:

a reservoir containing a liquid,

a vial containing a dry drug,

means for establishing a fluid connection between the reservoir and the vial,

first forcing means for forcing the liquid from the reservoir to the vial, via an established fluid connection, thereby causing the dry drug to become reconstituted, wherein the reservoir, the vial, the means for establishing a fluid connection and the forcing means form an at least substantially integral unit.