Fluid transfer devices and methods of use

• US 9,827,163 B2
• Filed: 12/01/2016
• Issued: 11/28/2017
• Est. Priority Date: 07/29/2009
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Lopez, George A., Fangrow, Thomas F., Leissling, Peter, Janssen, Matthias
• Primary Examiner(s): Maust, Timothy L
• Assistant Examiner(s): KELLY, TIMOTHY PATRICK
• Application Number:
  US15/366,208
• Publication Number:
  US 20170079883A1
• Time in Patent Office: 362 Days
• Field of Search: 141 9, 141 23- 27, 141301-302, 141329-330, 604407, 604408, 604410, 604411, 604416, 604905
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2062 with directional valves
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• 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: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 2200/76 for fluid level
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: B67D 3/0003 provided with automatic fluid control means
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Some embodiments disclosed herein related to a device for transferring precise amounts of fluid from at least one source container to a at least one target container. In some embodiments, the fluid is first transferred from the source container (e.g., a vial) through a connector to an intermediate measuring container (e.g., a syringe). In some embodiments air can pass through an air inlet and enter the vial to compensate for the volume of fluid withdrawn from the vial. An air check valve or a bag or a filter can prevent the fluid from escaping through the air inlet. The precisely measured amount of fluid can then be transferred from the intermediate measuring container to the target container (e.g., an IV bag). In some embodiments the connector can include a source check valve and a target check valve to direct fluid first from the source container to the intermediate measuring container and then from the intermediate measuring container to the target container. Some embodiments of the device can include a motor and a controller for automatically actuating a plunger of the syringe to transfer the desired amount of fluid.

Claims

1. A fluid transfer module for use with a substantially entirely closed system for the transfer of medical fluids between or among different medical fluid containers by an electronically controlled fluid dispensing system, the fluid transfer module configured to be removably attachable to the electronically controlled fluid dispensing system, the fluid transfer module comprising:

a first interface configured to be connected in fluid communication with a fluid source container, the first interface comprising a valve member movable between a closed position and an open position, the valve member configured to be in the open position when the fluid source container is attached to the first interface, and the valve member configured to close automatically when the fluid source container is detached from the first interface, wherein in the closed position the valve member is configured to substantially entirely prevent fluid within the fluid transfer module from escaping through the first interface;

a second interface configured to be connected in fluid communication with a fluid destination container, the second interface comprising a valve member movable between a closed position and an open position, the valve member configured to be in the open position when the fluid destination container is attached to the second interface, and the valve member configured to close automatically when the fluid destination container is detached from the second interface, wherein in the closed position the valve member is configured to substantially entirely prevent fluid within the fluid transfer module from escaping through the second interface;

an intermediate container or an intermediate interface configured to be connected to an intermediate container;

a valve system having a first configuration configured to permit the passage of fluid from the first interface to the intermediate container or the intermediate interface and to inhibit the passage of fluid from the second interface to the intermediate container or the intermediate interface, and a second configuration configured to permit the passage of fluid from the intermediate container or the intermediate interface to the second interface and to inhibit the passage of fluid from the intermediate container or the intermediate interface to the first interface; and

a sensor region positioned between the valve system and the intermediate container or the intermediate interface such that the sensor region is configured to permit a bubble sensor of the electronically controlled fluid dispensing system to detect air in a fluid passageway of the fluid transfer module;

wherein the fluid transfer module is configured to be attachable and detachable by a user from the electronically controlled fluid dispensing system; and

wherein the fluid transfer module is configured to substantially prevent fluid within the fluid transfer module from escaping upon disconnection of the fluid transfer module from the fluid source container and the fluid destination container.

2. The fluid transfer module of claim 1, wherein the valve system comprises:

a source check valve configured to permit the passage of fluid from the fluid source container to the intermediate container and configured to generally obstruct the passage of fluid from the intermediate container to the fluid source container; and

a target check valve configured to permit the passage of fluid from the intermediate container to the fluid destination container and to generally obstruct the passage of fluid from the fluid destination container to the intermediate container.

3. The fluid transfer module of claim 1, wherein the valve system comprises a single valve assembly that includes a source check valve and a target check valve integrally formed as a single piece.

4. The fluid transfer module of claim 1, wherein the sensor region comprises an outer housing portion that is generally transparent to light of an optical sensor such that light of the optical sensor can pass through the fluid passageway in the fluid transfer module to permit the electronically controlled fluid dispensing system to detect air in the fluid passageway of the fluid transfer module.

5. The fluid transfer module of claim 1, wherein the fluid transfer module can be a T-connector wherein the second interface extends substantially perpendicular to a line extending from the first interface to the intermediate container or the intermediate interface.

6. The fluid transfer module of claim 1, further comprising a fluid source container in fluid communication with the first interface.

7. The fluid transfer module of claim 1, further comprising a fluid destination container in fluid communication with the second interface.

8. The fluid transfer module of claim 1, wherein the first interface is a closeable male luer connector.

9. The fluid transfer module of claim 1, wherein the second interface is a closeable male luer connector.

10. The fluid transfer module of claim 1, further comprising an intermediate container configured to connect to the intermediate interface.

11. The fluid transfer module of claim 1, wherein the fluid transfer module comprises the intermediate container.

12. A fluid transfer system comprising:

an electronically controlled fluid dispensing system; and

the fluid transfer module of claim 1 removably attached to the electronically controlled fluid dispensing system.

13. The fluid transfer system of claim 12, wherein the electronically controlled fluid dispensing system comprises a beam emitter and a beam detector, and wherein the electronically controlled fluid dispensing system is capable of detecting air bubbles in the fluid transfer module.

14. The fluid transfer system of claim 12, wherein the electronically controlled fluid dispensing system comprises a bubble sensor configured to align with the sensor region of the fluid transfer module for detecting air in the fluid passageway of the fluid transfer module.

15. A method of providing a fluid transfer module for use with a closed system for the transfer of medical fluids between or among different medical fluid containers by an electronically controlled fluid dispensing system, the fluid transfer module configured to be removably attachable to the electronically controlled fluid dispensing system, the method comprising:

providing a fluid transfer module comprising;

a first interface configured to be connected in fluid communication with a fluid source container, the first interface comprising a valve member movable between a closed position and an open position, the valve member configured to be in the open position when the fluid source container is attached to the first interface, and the valve member configured to close automatically when the fluid source container is detached from the first interface, wherein in the closed position the valve member is configured to resist the escape of fluid within the fluid transfer module through the first interface;

a second interface configured to be connected in fluid communication with a fluid destination container, the second interface comprising a valve member movable between a closed position and an open position, the valve member configured to be in the open position when the fluid destination container is attached to the second interface, and the valve member configured to close automatically when the fluid destination container is detached from the second interface, wherein in the closed position the valve member is configured to resist the escape of fluid within the fluid transfer module through the second interface;

an intermediate container or an intermediate interface configured to be connected to an intermediate container;

a valve system having a first configuration configured to permit the passage of fluid from the first interface to the intermediate container or the intermediate interface and to inhibit the passage of fluid from the second interface to the intermediate container or the intermediate interface, and a second configuration configured to permit the passage of fluid from the intermediate container or the intermediate interface to the second interface and to inhibit the passage of fluid from the intermediate container or the intermediate interface to the first interface; and

a sensor region between the valve system and the intermediate container or the intermediate interface, wherein the sensor region is positioned so as to align with a bubble sensor of the electronically controlled fluid dispensing system, the sensor region configured to permit the bubble sensor to detect air in a fluid passageway of the fluid transfer module; and

wherein the fluid transfer module is configured to be attachable and detachable by a user from the electronically controlled fluid dispensing system; and

wherein the fluid transfer module is configured to resist the escape of fluid from the fluid transfer module upon disconnection of the fluid transfer module from the fluid source container and the fluid destination container.

16. The method of claim 15, wherein the valve system comprises:

a source check valve configured to permit the passage of fluid from the fluid source container to the intermediate container and configured to generally obstruct the passage of fluid from the intermediate container to the fluid source container; and

a target check valve configured to permit the passage of fluid from the intermediate container to the fluid destination container and to generally obstruct the passage of fluid from the fluid destination container to the intermediate container.

17. The method of claim 15, wherein the valve system comprises a single valve assembly that includes a source check valve and a target check valve integrally formed as a single piece.

18. The method of claim 15, wherein the sensor region comprises an outer housing portion that is generally transparent to light of an optical sensor such that light of the optical sensor can pass through the fluid passageway in the fluid transfer module to permit the electronically controlled fluid dispensing system to detect air in the fluid passageway of the fluid transfer module.

19. The method of claim 15, wherein the fluid transfer module can be a T-connector, wherein the second interface extends substantially perpendicular to a line extending from the first interface to the intermediate container or the intermediate interface.

20. The method of claim 15, further comprising providing a fluid source container in fluid communication with the first interface.

21. The method of claim 15, further comprising providing a fluid destination container in fluid communication with the second interface.

22. The method of claim 15, wherein the first interface is a closeable male luer connector.

23. The method of claim 15, wherein the second interface is a closeable male luer connector.

24. The method of claim 15, further comprising providing an intermediate container configured to connect to the intermediate interface.

25. The method of claim 15, wherein the fluid transfer module comprises the intermediate container.

26. The method of claim 15, further comprising providing an electronically controlled fluid dispensing system.

27. The method of claim 26, wherein the electronically controlled fluid dispensing system comprises a beam emitter and a beam detector, and wherein the electronically controlled fluid dispensing system is capable of detecting air bubbles in the fluid transfer module.

28. The method of claim 26, wherein the electronically controlled fluid dispensing system comprises a bubble sensor configured to align with the sensor region of the fluid transfer module for detecting air in the fluid passageway of the fluid transfer module.

29. A method of providing a fluid transfer module for use in a system for transferring fluid from a source container to a destination container, the method comprising:

providing a first interface configured to be connected in fluid communication with a fluid source container, the first interface comprising a valve member movable between a closed position and an open position, the valve member configured to be in the open position when the fluid source container is attached to the first interface, and the valve member configured to close automatically when the fluid source container is detached from the first interface, wherein in the closed position the valve member is configured to prevent fluid within the fluid transfer module from escaping through the first interface;

providing a second interface configured to be connected in fluid communication with a fluid destination container, the second interface comprising a valve member movable between a closed position and an open position, the valve member configured to be in the open position when the fluid destination container is attached to the second interface, and the valve member configured to close automatically when the fluid destination container is detached from the second interface, wherein in the closed position the valve member is configured to prevent fluid within the fluid transfer module from escaping through the second interface;

providing an intermediate container or an intermediate interface configured to be connected to an intermediate container; and

providing a valve system having a first configuration and a second configurations, wherein the first configuration of the valve system provides an open fluid pathway from the first interface to the intermediate container or the intermediate interface, wherein the first configuration of the valve system does not provide an open fluid pathway from the intermediate container or the intermediate interface to the second interface, wherein the second configuration of the valve system provides an open fluid pathway from the intermediate container or the intermediate interface to the second interface, and wherein the second configuration of the valve system does not provide an open fluid pathway from the first interface to the intermediate container or the intermediate interface;

wherein the fluid transfer module comprises a sensor region between the valve system and the intermediate container or the intermediate interface, wherein the sensor region is positioned in a location on the fluid transfer module to permit a bubble sensor of an electronically controlled fluid dispensing system to detect air in a fluid passageway of the fluid transfer module.

30. The method of claim 29, further comprising providing one or more of a fluid source container, a fluid destination container, an intermediate container, and an electronically controlled fluid dispensing system.