Drug reconstitution system

• US 9,662,621 B2
• Filed: 03/04/2013
• Issued: 05/30/2017
• Est. Priority Date: 03/09/2012
• Status: Active Grant

• Current Assignee: Sensile Medical AG (Gerresheimer AG)
• Original Assignee: Sensile Pat Ag
• Inventors: Beyer, Uwe, Gerber, Thomas, Brandt, Derek, Robin, Franck
• Primary Examiner(s): SOOHOO, TONY GLEN
• Application Number:
  US14/383,141
• Publication Number:
  US 20150029816A1
• Time in Patent Office: 1,548 Days
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14236 Screw, impeller or centrifugal type pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: B01F 2101/2202 Mixing compositions or mixers in the medical or veterinary field
• CPC Class Codes: B01F 35/32005 Type of drive
• CPC Class Codes: B01F 35/7176 using pumps

Abstract

A drug reconstitution device comprising a disposable liquid transfer unit (18) and a reusable control and drive unit (16) removably connectable to the liquid transfer unit, the liquid transfer unit including a housing (26), a docking interface (30) configured for coupling at least one of the first and second constituent containers (2, 4) to the housing (10), and a pump engine (28) and fluid flow system (36) configured for transferring liquid from the first constituent container (2) to the second constituent container (4). The control and drive unit comprises a pump drive (22) configured to drive the pump engine during a liquid transfer action, the pump drive comprising a transmission output coupling (34) removably engaged with a transmission input coupling (50) of the pump engine (28) when the liquid transfer unit and control and drive unit are connected.

Claims

1. A drug reconstitution device comprising a single use disposable liquid transfer unit (18) and a reusable control and drive unit (16) removably connectable to the liquid transfer unit, the disposable liquid transfer unit including a housing (26), a docking interface (30) configured for coupling at least one of a first and a second constituent containers (2, 4) to the housing (10), and a pump engine (28) and fluid flow system (37) configured for transferring liquid from the first constituent container (2) to the second constituent container (4), the control and drive unit comprising a pump drive (22) configured to drive the pump engine during a fluid pumping action, the pump drive comprising a transmission output coupling (34) removably engaged with a transmission input coupling (50) of the pump engine (28) when the liquid transfer unit and control and drive unit are connected, wherein the pump engine is configured as a rotary pump and comprises a rotor rotatably moveable in a stator and integrated with said transmission input coupling (50), the transmission input coupling removably engageable with a transmission output coupling of the pump drive.

2. The drug reconstitution device according to claim 1, wherein the docking interface (30) comprises a first container docking interface (42) configured to interconnect the first constituent container with the fluid flow system (36) in a fluidic manner and a second container docking interface (44) configured to interconnect the second constituent container with the fluid flow system (36) in a fluidic manner.

3. The drug reconstitution device according to claim 2, wherein the first docking interface has a different shape or profile or size than the second docking interface, configured to prevent connection of the first constituent container in the second container docking interface and connection of the second constituent container in the first container docking interface.

4. The drug reconstitution device according to claim 2, wherein the fluid flow system (36) comprises a first fluidic channel (60) and a second fluidic channel (62) and the pump engine comprises a pump chamber (41), said first fluidic channel interconnecting the first container docking interface (42) with the pump chamber in a fluidic manner and said second fluidic channel interconnecting the second container docking interface (44) with the pump chamber (41) in a fluidic manner.

5. The drug reconstitution device according to claim 1, wherein the docking interface comprises a locking mechanism configured to lock at least one of the first and second constituent containers to the housing when said constituent container is connected to the docking interface.

6. The drug reconstitution device according to claim 5, wherein the first container docking interface (42) comprises a locking mechanism (52) configured to lock the first constituent container (2) to the housing (26) when said constituent container is connected to the first container docking interface.

7. The drug reconstitution device according to claim 6, wherein at least one of said locking mechanism is irreversible and configured to irremovably couple at least one of said containers to the liquid transfer unit.

8. The drug reconstitution device according to claim 1, wherein the pump engine is configured as a bi-directional pump.

9. The drug reconstitution device according to claim 1, wherein the pump engine is configured as a uni-directional pump.

10. The drug reconstitution device according to claim 1 configured as a portable device, the control and drive unit comprising an autonomous power source.

11. The drug reconstitution device according to claim 1, wherein the device comprises a releasable locking mechanism configured to lock the control and drive unit to the liquid transfer unit during a liquid transfer operation.

12. The drug reconstitution device according to claim 1, wherein the pump engine rotor is directly attached to the transmission input coupling.

13. A drug reconstitution device comprising a single use disposable liquid transfer unit 18 and a reusable control and drive unit (16) removably connectable to the liquid transfer unit, the disposable liquid transfer unit including a housing (26), a docking interface (30) configured for coupling at least one of a first and a second constituent containers (2, 4) to the housing (10), and a pump engine (28) and fluid flow system (37) configured for transferring liquid from the first constituent container (2) to the second constituent container (4), the control and drive unit comprising au drive (22) configured to drive the pump engine during a fluid pumping action, the pump drive comprising a transmission output coupling (34) removably engaged with a transmission input coupling (50) of the pump engine (28) when the liquid transfer unit and control and drive unit are connected, wherein the pump engine is configured as a rotary pump and comprises a rotor rotatably moveable in a stator and integrated with said transmission input coupling (50), the transmission input coupling removably engageable with a transmission output coupling of the pump drive, wherein the transmission output coupling (34) is in the form of a spring biased shaft.

14. The drug reconstitution device according to claim 13, wherein the docking interface comprises a first container docking interface configured to interconnect the first constituent container with the fluid flow system in a fluidic manner and a second container docking interface configured to interconnect the second constituent container with the fluid flow system in a fluidic manner.

15. The drug reconstitution device according to claim 14, wherein the first docking interface has a different shape or profile or size than the second docking interface, configured to prevent connection of the first constituent container in the second container docking interface and connection of the second constituent container in the first container docking interface.

16. The drug reconstitution device according to claim 14, wherein the fluid flow system comprises a first fluidic channel and a second fluidic channel and the pump engine comprises a pump chamber, said first fluidic channel interconnecting the first container docking interface with the pump chamber in a fluidic manner and said second fluidic channel interconnecting the second container docking interface with the pump chamber in a fluidic manner.

17. The drug reconstitution device according to claim 13, wherein the docking interface comprises a locking mechanism configured to lock at least one of the first and second constituent containers to the housing when said constituent container is connected to the docking interface.

18. The drug reconstitution device according to claim 17, wherein the first container docking interface comprises a locking mechanism configured to lock the first constituent container to the housing when said constituent container is connected to the first container docking interface.

19. The drug reconstitution device according to claim 18, wherein at least one of said locking mechanism is irreversible and configured to irremovably couple at least one of said containers to the liquid transfer unit.

20. The drug reconstitution device according to claim 13, wherein the pump engine is configured as a bi-directional pump.

21. The drug reconstitution device according to claim 13, wherein the pump engine is configured as a uni-directional pump.

22. The drug reconstitution device according to claim 13 configured as a portable device, the control and drive unit comprising an autonomous power source.

23. The drug reconstitution device according to claim 13, wherein the device comprises a releasable locking mechanism configured to lock the control and drive unit to the liquid transfer unit during a liquid transfer operation.

24. The drug reconstitution device according to claim 13, wherein the pump engine rotor is directly attached to the transmission input coupling.

25. A drug reconstitution device comprising a single use disposable liquid transfer unit (18) and a reusable control and drive unit (16) removably connectable to the liquid transfer unit, the disposable liquid transfer unit including a housing (26), a docking interface (30) configured for coupling at least one of first and second constituent containers (2, 4) to the housing (10), and a pump engine (28) and fluid flow system (37) configured for transferring liquid from the first constituent container (2) to the second constituent container (4), the control and drive unit comprising a pump drive (22) configured to drive the pump engine during a fluid pumping action, the pump drive comprising a transmission output coupling (34) removably engaged with a transmission input coupling (50) of the pump engine (28) when the liquid transfer unit and control and drive unit are connected, wherein the pump engine is integrally mounted in the liquid transfer unit (18) and is configured as a bi-directional rotary pump and comprises a rotor rotatably moveable in a stator and integrated with said transmission input coupling (50), the transmission input coupling removably engageable with a transmission output coupling of the pump drive.

26. The drug reconstitution device according to claim 25, wherein the docking interface comprises a first container docking interface configured to interconnect the first constituent container with the fluid flow system in a fluidic manner and a second container docking interface configured to interconnect the second constituent container with the fluid flow system in a fluidic manner.

27. The drug reconstitution device according to claim 26, wherein the first docking interface has a different shape or profile or size than the second docking interface, configured to prevent connection of the first constituent container in the second container docking interface and connection of the second constituent container in the first container docking interface.

28. The drug reconstitution device according to claim 26, wherein the fluid flow system comprises a first fluidic channel and a second fluidic channel and the pump engine comprises a pump chamber, said first fluidic channel interconnecting the first container docking interface with the pump chamber in a fluidic manner and said second fluidic channel interconnecting the second container docking interface with the pump chamber in a fluidic manner.

29. The drug reconstitution device according to claim 25, wherein the docking interface comprises a locking mechanism configured to lock at least one of the first and second constituent containers to the housing when said constituent container is connected to the docking interface.

30. The drug reconstitution device according to claim 29, wherein the first container docking interface comprises a locking mechanism configured to lock the first constituent container to the housing when said constituent container is connected to the first container docking interface.

31. The drug reconstitution device according to claim 30, wherein at least one of said locking mechanism is irreversible and configured to irremovably couple at least one of said containers to the liquid transfer unit.

32. The drug reconstitution device according to claim 25 configured as a portable device, the control and drive unit comprising an autonomous power source.

33. The drug reconstitution device according to claim 25, wherein the device comprises a releasable locking mechanism configured to lock the control and drive unit to the liquid transfer unit during a liquid transfer operation.

34. The drug reconstitution device according to claim 25, wherein the pump engine rotor is directly attached to the transmission input coupling.