FLUID TRANSFER DEVICES AND METHODS OF USE

• US 20110062703A1
• Filed: 07/28/2010
• Published: 03/17/2011
• Est. Priority Date: 07/29/2009
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Janssen, Matthias, Leissling, Peter, Lopez, George A., Fangrow, Thomas F. JR.
• Granted Patent: US 8,522,832 B2
• Time in Patent Office: Days
• US Class Current: 285/129.1
• 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 In some embodiments air can pass through an air inlet and enter the vial to compensate for the volume of fluid withdrawn from the vial.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 method of providing a substantially entirely closed system for the transfer of medical fluids between or among different medical fluid containers, the method comprising:

(a) providing a fluid transfer module configured to be removably attachable to an electronically controlled fluid dispensing system, the fluid transfer module comprising;

(i) a first interface configured to be connected in fluid communication with a fluid source container, the first interface comprising a first selectively openable and closeable aperture that is configured to substantially entirely prevent fluid within the fluid transfer module from escaping through the first aperture when the first aperture is closed;

(ii) a second interface configured to be connected in fluid communication with a fluid destination container, the second interface comprising a second selectively openable and closeable aperture that is configured to substantially entirely prevent fluid within the fluid transfer module from escaping through the second aperture when the second aperture is closed;

(iii) an intermediate container or an intermediate interface configured to be connected to an intermediate container;

(iv) a first 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

(v) a second 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; and

(b) instructing a user to attach the fluid transfer module to an electronically controlled fluid dispensing system to assist in transferring fluid;

wherein an interaction portion of the fluid transfer module is configured to permit the electronically controlled fluid dispensing system to indicate that at least a portion of the fluid transfer module is attached to the electronically controlled fluid dispensing system; and

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

2. The method of claim 1, further comprising the step of providing the electronically controlled fluid dispensing system.

3. The method of claim 1, further comprising the step of providing the fluid source container;

4. The method of claim 3, wherein the fluid source container is a medicinal vial.

5. The method of claim 1, further comprising the step of providing a vial adapter configured to removably connect to the first interface between the fluid transfer module and the fluid source container.

6. The method of claim 5, wherein the vial adapter comprises a selectively openable and closeable fluid passage that substantially prevents fluid within the vial adapter from escaping after the vial adapter is detached from the first interface.

7. The method of claim 1, further comprising the step of providing the fluid destination container.

8. The method of claim 7, wherein the fluid destination container is an IV bag.

9. The method of claim 8, further comprising the step of providing a selectively closeable fluid connector configured to removably connect to the second interface between the fluid transfer module and the IV bag.

10. The method of claim 9, wherein the selectively closeable fluid connector substantially prevents fluid within the IV bag from escaping after the IV bag is detached from the second interface.

11. The method of claim 1, wherein the interaction portion of the fluid transfer module is configured to permit the electronically controlled fluid dispensing system to indicate that the second aperture is open.

12. The method of claim 2, wherein the electronically controlled fluid dispensing system comprises a beam emitter and a beam detector, and wherein the electronically controlled fluid dispensing system indicates that at least a portion of the fluid transfer module is attached to the electronically controlled fluid dispensing system by detecting that a beam emitted from the barn emitter has not been detector by the beam detector.

13. The method of claim 1, wherein the interaction portion of the fluid transfer module comprises a generally opaque outer housing.

14. The method of claim 11, wherein the interaction portion of the fluid transfer module comprises a generally transparent outer housing and a moveable portion within the generally transparent outer housing comprising a generally opaque portion.

15. The method of claim 1, wherein the fluid transfer module is configured to be disposable.

16. The method of claim 1, further comprising the step of instructing the user to dispose of the fluid transfer module after a single use.

17. The method of claim 1, further comprising the step of instructing the user to dispose of the fluid transfer module in a biohazard receptacle.

18. The method of claim 5 wherein the vial adapter comprises a spike configured to pierce a septum on a medicinal vial.

19. The method of claim 1, further comprising the step of connecting the first interface to the fluid source container.

20. The method of claim 1, further comprising the step of connecting the second interface to the fluid destination container.

21. The method of claim 19, wherein the connection between the first interface and the fluid source container is a direct connection.

22. The method of claim 20, wherein the connection between the second interface and the fluid destination container is a direct connection.

23. The method of claim 1, further comprising the step of permitting fluid to pass from the fluid source container to the first interface.

24. The method of claim 23, further comprising the step of permitting fluid to pass from the first interface to the intermediate container.

25. The method of claim 24, further comprising the step of permitting fluid to pass from the intermediate container to the second interface.

26. The method of claim 25, further comprising the step of permitting fluid to pass from the second interface to the fluid destination container.

27. The method of claim 2, wherein the electronically controlled fluid dispensing system is capable of detecting air bubbles in the fluid transfer module.

28. The method of claim 1, wherein the first interface is a closeable male luer connector.

29. The method of claim 1, wherein the second interface is a closeable male luer connector.

30. The method of claim 1, wherein the fluid transfer module is configured to transfer chemotherapy fluids.

31. The method of claim 1, further comprising the step of providing the intermediate container.

32. The method of claim 31, wherein the fluid transfer module comprises the intermediate container.

33. A connector for use in a fluid transfer system that transfers precise amounts of fluid from a source container to a target container, the connector comprising:

a main housing defining a main interior chamber;

a source connector portion configured to provide at least a portion of a source fluid pathway between the main interior chamber and a source container;

an intermediate connector portion configured to provide at least a portion of an intermediate fluid pathway between the main interior chamber and an intermediate container; and

a target connector portion configured to provide at least a portion of a target fluid pathway between the main interior chamber and a target container;

wherein the target connector portion comprises a valve member movable between a closed position and an open position, the valve member configured to be in the closed position when the target container is detached from the target connector portion, and the valve member configured to be in the open position when the target container is attached to the target connector portion;

wherein the target connector portion is configured to align with at least one optical sensor when the connector is attached to the fluid transfer system, wherein at least a portion of the target connector portion is substantially transparent to allow light from the optical sensor to enter the target connector portion to detect whether the valve member is in the open position or the closed position.

34. The connector of claim 33, further comprising a source check valve configured to allow fluid to flow from the source connector portion to the intermediate connector portion and block fluid from flowing from the intermediate connector portion to the source connector portion.

35. The connector of claim 34, further comprising a target check valve configured to allow fluid to flow from the intermediate connector portion to the target connector portion and block fluid from flowing from the target connector portion to the intermediate connector portion.

36. The connector of claim 33, wherein at least a portion of the valve member is substantially opaque, wherein the target connector portion is configured to align with the at least one optical sensor when the connector is attached to the fluid transfer system such that the light from the at least one optical sensor does not intersect the opaque portion of the valve member when the valve member is in the closed position, and such that the light from the at least one optical sensor intersects the opaque portion of the valve member when the valve member is in the open position.

37. The connector of claim 33, wherein at least a portion of the valve member is substantially opaque, wherein the target connector portion is configured to align with the at least one optical sensor when the connector is attached to the fluid transfer system such that the light from the at least one optical sensor does not intersect the opaque portion of the valve member when the valve member is in the open position, and such that the light from the at least one optical sensor intersects the opaque portion of the valve member when the valve member is in the closed position.

38. The connector of claim 33, further comprising a source container attached to the source connector portion of the connector.

39. The connector of claim 37, wherein the source container comprises a vial and a vial adapter, the vial containing a fluid and having a septum, the vial adapter being attached to the source connector portion of the connector and having a spike penetrating the septum to provide access to the fluid.

40. The connector of claim 37, wherein the source container comprises a vial that contains a fluid and includes a septum, and the source connector portion comprises a spike penetrating the septum to provide access to the fluid.

41. The connector of claim 33, further comprising a target container attached to the target connector portion of the connector.

42. The connector of claim 41, wherein the target container comprises an IV bag.

43. The connector of claim 33, further comprising an intermediate container attached to the intermediate connector portion of the connector.

44. The connector of claim 43, wherein the intermediate container comprises a syringe configured to measure precise amounts of fluid to be transferred.

45. The connector of claim 33, further comprising a fluid transfer system configured to receive the connector.

46. The connector of claim 45, wherein the fluid transfer system comprises at least one optical sensor, the optical sensor comprising a light source positioned on a first side of the target connector portion and a light detector positioned on a second side of the target connector opposite the light source.

47. The connector of claim 46, wherein at least a portion of the valve member is substantially opaque, and wherein opaque portion of the valve member is not disposed between the light source and light detector when the valve member is in the closed configuration such that light is permitted to travel from the light source, through the target connector portion, to the light detector, and wherein the opaque portion of the valve member is disposed between the light source and the light detector when the valve member is in the open configuration such that light is blocked from traveling from the light source to the light detector.

48. The connector of claim 45, wherein the fluid transfer system comprises a controller in communication with the at least one optical sensor, the controller configured to allow fluid to be transferred when the at least one optical sensor detects that the valve member is in the open state indicating that the target container is attached thereto, and the controller being configured to not allow fluid to be transferred when the at least one optical sensor detects that the valve member is in the closed configuration indicating that the target container is not attached thereto.

49. A method of attaching a connector to a fluid transfer system, the method comprising:

providing a fluid transfer system that comprises at least one optical sensor;

providing a connector that comprises a source connector portion, an intermediate connector portion, and a target connector portion, the target connector portion comprising a valve member movable between an open position and a closed position; and

attaching the connector to the fluid transfer system such that the target connector portion aligns with the at least one optical sensor;

wherein at least a portion of the target connector portion is substantially transparent to allow light from the at least one optical sensor to enter the target connector portion to detect whether the valve member is in the open position or the closed position.

50. The method of claim 49, further comprising attaching a source container to the source connector portion of the connector.

51. The connector of claim 50, wherein the source container comprises a vial and a vial adapter, the vial containing a fluid and having a septum, the vial adapter being attached to the source connector portion of the connector and having a spike penetrating the septum to provide access to the fluid.

52. The connector of claim 50, wherein the source container comprises a vial that contains a fluid and includes a septum, and the source connector portion comprises a spike penetrating the septum to provide access to the fluid.

53. The method of claim 49, further comprising attaching a syringe to the intermediate connector portion of the connector, the syringe having a body and a plunger.

54. The method of claim 53, further comprising attaching the plunger of the syringe to an actuator on the fluid transfer system, the actuator being coupled to a motor and configured to move the plunger of the syringe to transfer fluid from a source container through the connector and into the syringe as the plunger is withdrawn and to transfer fluid from the syringe through the connector and into a target container as the plunger is advanced.

55. The method of claim 49, further comprising attaching an IV bag to the target connector portion of the connector.

56. A method of providing a connector for use in a system for transferring precise amounts of fluid from a source container to a target container, the method comprising:

providing a main housing defining a main interior chamber;

providing a source connector portion configured to form at least a portion of a source fluid pathway between the main interior chamber and a source container;

providing an intermediate connector portion configured to form at least a portion of an intermediate fluid pathway between the main interior chamber and an intermediate container;

providing a target connector portion configured to form at least a portion of a target fluid pathway between the main interior chamber and a target container; and

positioning a valve member inside the target connector portion, the valve member movable between a closed position and an open position, the valve member configured to be in the closed position when the target container is detached from the target connector portion, and the valve member configured to be in the open position when the target container is attached to the target connector portion;

wherein the target connector portion is configured to align with at least one optical sensor when the connector is attached to the fluid transfer system, wherein at least a portion of the target connector portion is substantially transparent to allow light from the at least one optical sensor to enter the target connector portion to detect whether the valve member is in the open position or the closed position.

57. The method of claim 56, further comprising positioning a source check valve between the source connector portion and intermediate connector portion, the source check valve configured to allow fluid to flow from the source connector portion to the intermediate connector portion and block fluid from flowing from the intermediate connector portion to the source connector portion.

58. The method of claim 56, further comprising positioning a target check valve between the intermediate connector portion and the target connector portion, the target check valve configured to allow fluid to flow from the intermediate connector portion to the target connector portion and block fluid from flowing from the target connector portion to the intermediate connector portion.

59. The method of claim 56, wherein at least a portion of the valve member is substantially opaque, wherein the target connector portion is configured to align with the at least one optical sensor when the connector is attached to the fluid transfer system such that the light from the at least one optical sensor does not intersect the opaque portion of the valve member when the valve member is in the closed position, and such that the light from the at least one optical sensor intersects the opaque portion of the valve member when the valve member is in the open position.

60. The method of claim 56, wherein at least a portion of the valve member is substantially opaque, wherein the target connector portion is configured to align with the at least one optical sensor when the connector is attached to the fluid transfer system such that the light from the at least one optical sensor does not intersect the opaque portion of the valve member when the valve member is in the open position, and such that the light from the at least one optical sensor intersects the opaque portion of the valve member when the valve member is in the closed position.