Mixing and/or reconstitution system and respective method

Patent metadata

Field	Value
Publication number	US-11504473-B2
Application number	US-201816763282-A
Country	US
Kind code	B2
Filing date	Nov 15, 2018
Priority date	Nov 17, 2017
Publication date	Nov 22, 2022
Grant date	Nov 22, 2022

Abstract

A mixing and/or reconstitution system reduces the possibility of user error and provides a well mixed and/or reconstituted drug in a short time. The system comprises a device containing a first material within a first chamber, a housing, and a plunger, the plunger comprising a second chamber containing a second material, wherein one of the first and the second material is a fluid, and a movable element with an electric, magnetic, or paramagnetic characteristic, wherein the second chamber is initially closed; and a base unit comprising a recess for accommodation of the device, a control unit, and an electromagnetic unit which is adapted to produce an electromagnetic field penetrating the recess, wherein the control unit can electrically operate the electromagnetic unit such that the element contained in the second chamber moves in a direction of the device determined by the electromagnetic field and fluidly communicates the first and second chambers.

First claim

The invention claimed is:

1. A device comprising:
a first material within a first chamber;
a housing; and
a plunger comprising a second chamber comprising a second material and a movable element with an electric, magnetic, or paramagnetic characteristic,
wherein one of the first material and the second material is a fluid,
wherein the second chamber is initially closed,
wherein the movable element, the first chamber, and the second chamber are adapted such that after activation by an electromagnetic field, the movable element moves in a pre-determined direction of the device and thereby opens a path providing a fluid communication between the first chamber and the second chamber.

2. The device according to claim 1 , wherein the movable element is a slug-like element and comprises a tip at a distal end.

3. The device according to claim 2 , wherein the movable element comprises a tapered face at a proximal end.

4. The device according to claim 1 , wherein the slug-like element comprises a permanent magnetic material or a soft magnetic material.

5. The device according to claim 1 , further comprising a filter at a distal end of the first chamber ( 205 ).

6. The device according to claim 5 , further comprising a seal that is adapted such that the seal does not produce a shard when punctured or ruptured by the slug-like element.

7. The device according to claim 1 , wherein the plunger comprises a plate-like element comprising a soft magnetic material accommodated proximally with regard to the second chamber.

8. A system comprising:
a device comprising:
a first material within a first chamber,
a housing, and
a plunger comprising a second chamber comprising a second material and a movable element with an electric, magnetic, or paramagnetic characteristic,
wherein one of the first material and the second material is a fluid,
wherein the second chamber is initially closed, and
wherein the movable element, the first chamber, and the second chamber are adapted such that after activation by an electromagnetic field, the movable element moves in a pre-determined direction of the device and thereby opens a path providing a fluid communication between the first chamber and the second chamber; and

a base unit comprising:
a recess for accommodating the device,
a control unit, and
an electromagnetic unit that is adapted to produce an electromagnetic field that penetrates the recess,
wherein the control unit electrically operates the electromagnetic unit, and
wherein the base unit is adapted such that after accommodating the device within the recess and after user activation of the base unit, the control unit operates the electromagnetic unit such that the movable element contained in the second chamber moves in a direction of the device determined by the electromagnetic field and thereby opens the path providing the fluid communication between the first chamber and the second chamber.

9. The system according to claim 8 , wherein the electromagnetic unit comprises at least one electromagnetic coil surrounding the recess for the device.

10. The system according to claim 9 , wherein the electromagnetic unit comprises a series of electromagnetic coils and milled steel pole pieces in between two adjacent electromagnetic coils.

11. The system according to claim 10 , wherein the control unit is adapted to energize electromagnetic coils such that the electromagnetic field moves the movable element back and forth along the pre-determined direction of the device.

12. The system according to claim 8 , wherein the electromagnetic unit comprises at least one permanent magnet that is moveable along the pre-determined direction of the device.

13. The system according to claim 8 , wherein the movable element is a slug-like element and comprises a tip at a distal end.

14. The system according to claim 13 , wherein the movable element comprises a tapered face at a proximal end.

15. The system according to claim 8 , wherein the slug-like element comprises a permanent magnetic material or a soft magnetic material.

16. The system according to claim 8 , wherein the device further comprises a filter at a distal end of the first chamber.

17. The system according to claim 8 , wherein the plunger comprises a plate-like element comprising a soft magnetic material accommodated proximally with regard to the second chamber.

18. A method comprising:
accommodating a device within a recess of a base unit; the device comprising:
a first material within a first chamber,
a housing, and
a plunger comprising a second chamber comprising a second material and a movable element with an electric, magnetic, or paramagnetic characteristic,
wherein one of the first material and the second material is a fluid,
wherein the second chamber is initially closed,
wherein the base unit comprises an electromagnetic unit that is adapted to produce an electromagnetic field that penetrates the recess; and

operating the electromagnetic unit by a control unit after activation such that the movable element within the second chamber of the device moves in a direction of the device determined by the electromagnetic field and thereby opens a path providing a fluid communication between the first chamber and the second chamber.

19. The method according to claim 18 , wherein the electromagnetic unit is operated such that the electromagnetic field moves the movable element back and forth along a pre-defined direction of the device.

20. The method according to claim 18 , wherein the electromagnetic unit is operated such that at least one permanent magnet of the electromagnetic unit moves along a pre-defined direction of the device after activation.

Assignees

• Sanofi Sa
• Sagentia Ltd

Inventors

• Schabbach Michael
• Kadereit Dieter
• Heiberger Andrea
• Geiger Claus
• Harvey Charlotte Emma
• Huang Congyi
• Frearson Timothy Charles
• Norman Alexander David

Classifications

• A61M2209/04

  Tools for specific apparatus · CPC title

• A61M2005/3128

  Incorporating one-way valves, e.g. pressure-relief or non-return valves · CPC title

• A61M5/2053

  Media being expelled from injector by pressurised fluid or vacuum (for infusion A61M5/145, A61M5/155) · CPC title

• A61M5/31596 Primary

  comprising means for injection of two or more media, e.g. by mixing · CPC title

• A61M5/2448

  comprising means for injection of two or more media, e.g. by mixing · CPC title