MEDICAL MIXING DEVICE

• US 20100331773A1
• Filed: 11/21/2008
• Published: 12/30/2010
• Est. Priority Date: 11/22/2007
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: NOVO Nordisk Biotech Incorporated (Novo Nordisk A/S)
• Inventors: Nielsen, Per Valentin, Frederiksen, Morten Revsgaard
• Application Number:
  US12/743,443
• Publication Number:
  US 20100331773A1
• Time in Patent Office: Days
• US Class Current: 604/84
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2062 with directional valves
• 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 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• 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 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• 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 (102) containing a liquid, a vial (101) containing a dry drug, such as a lyophilized drug, means (110) for forcing the liquid from the reservoir to the vial, via an established fluid connection, and valve means (106-108) to ensure a tight fluid connection between reservoir and vial can be established before the fluid paths are opened.

Claims

1. A drug storage and delivery device comprising:

a reservoir containing a liquid,

a vial containing a dry drug,

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,

means for establishing fluid connection between the reservoir and the vial comprising at least two flow paths,

primary valve means adapted to open or shut each of said at least two flow paths, and

secondary valve means adapted to restrict the flow direction in each of said at least two flow paths, wherein

the reservoir, the vial, the means for establishing a fluid connection between the reservoir and the vial, the primary valve means, the secondary valve means and the first forcing means form an integral unit.

2. A device according to claim 1, wherein the primary valve means is a manually operateable three-way valve and the secondary valve means are one-way valves.

3. A device according to claim 2, wherein the manually operateable three-way valve can be set in one of a:

a shut-off position, wherein each of the at least two flow paths are blocked so there is no fluid connection between the reservoir and the vial,

a first position, wherein one of the at least two flow paths are open so there is fluid connection between the reservoir and the vial in a flow-direction from the reservoir to the vial, and

a second position, wherein a second of the at least two flow paths are open so there is fluid connection between the reservoir and the vial in a flow-direction from the vial to the reservoir.

4. A device according to claim 1, wherein the primary valve means are separate and manually operateable shut-off valves enabled to open or shut the fluid connection through each of the at least two flow paths and the secondary valve means are one-way valves.

5. A device according to claim 4, wherein the primary valve means and the secondary valve means are integrated respectively, whereby each of the at least two flow paths comprise an integrated one-way and manually operateable shut-off valve.

6. A device according to claim 4, wherein the manually operateable shut-off valves are interlocked whereby only one of the shut-off valves can be open at a time.

7. A device according to claim 1, wherein the force direction for forcing the liquid from the reservoir to the vial is opposed by the actuating direction for actuating the primary valve means to open the one of the flow paths which establishes fluid connection from the reservoir to the vial only in a flow direction from the reservoir to the vial.

8. A device according to claim 1, wherein the force direction for forcing the reconstituted liquid drug from the vial back to the reservoir is opposed by the actuating direction for actuating the primary valve means to open the one of the flow paths which establishes fluid connection from the vial to the reservoir only in a flow direction from the vial to the reservoir.

9. 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 and a second spike adapted to penetrate the reservoir.

10. A device according to claim 1, further comprising means for delivering a reconstituted drug from the device, the delivering means comprises second forcing means adapted to force a reconstituted drug towards an outlet opening for delivery of the reconstituted drug.

11. A method of mixing two substances in 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 of:

moving the reservoir and the vial towards each other, thereby establishing a manually operateable fluid connection between the reservoir and the vial,

manually operating primary valve means to establish fluid connection from the reservoir to the vial in a flow direction from the reservoir to the vial only,

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

manually operating primary valve means to establish fluid connection from the vial to the reservoir in a flow direction from the vial to the reservoir only, thereby allowing reconstituted drug to return to the reservoir, and

actively or passively operating primary valve means to a position where fluid connection between the reservoir and the vial in any flow direction is shut, thereby preventing flow-back of the reconstituted drug from the reservoir to the vial.