Fluid control device with valve and methods of use

• US 7,771,383 B2
• Filed: 10/22/2004
• Issued: 08/10/2010
• Est. Priority Date: 10/22/2004
• Status: Active Grant

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Medegen Inc.
• Inventors: Truitt, Tim L., Mazza, Alex Truman
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): FLICK, JASON E
• Application Number:
  US10/972,312
• Publication Number:
  US 20060089603A1
• Time in Patent Office: 2,118 Days
• Field of Search: 604/32
• US Class Current: 604/32
• CPC Class Codes: A61M 2039/266 where the valve comprises venting channels, e.g. to insure better connection, to help decreasing the fluid space upon disconnection, or to help the fluid space to remain the same during disconnection
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2209/04 Tools for specific apparatus
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/162 with antiseptic agent incorporated within the connector
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

A fluid control device for directing fluid flow comprising a needleless access device for transferring fluids and methods of directing fluid flow. The fluid control device may have a first port, a second port, a third port and a connecting portion joining the first, second and third ports. A first valve element may be positioned within the first port and a fluid director may be positioned within the connecting portion. The first valve element may move between an opening position, where fluid may flow past the first valve element, and a closed position, where fluid may be prevented from flowing past the first valve element. The fluid director may have at least one passageway for connecting at least two of the first, second and third ports such that fluid may flow therebetween. An actuation mechanism may be used to orient the fluid director and, consequently, the at least one passageway within the connecting portion.

Claims

1. A fluid control device for transferring fluid comprising:

a monolithic housing having a first port, a second port, a third port, and a connecting portion connecting the first, second and third ports, the first port having a longitudinal axis;

a needleless access device incorporated into the first port, the needleless access device including a first valve element positioned within the first port, the first valve element having a proximal end, a distal end, an axis, a first position when the needleless access device is not actuated where the axis of the first valve element is parallel with the longitudinal axis of the first port, and a second position when the needleless access device is actuated where the axis of the first valve element is displaced from the longitudinal axis of the first port;

a fluid director having at least one fluid passageway, wherein the fluid director is positionable within the housing; and

an actuation mechanism operably associated with the fluid director, wherein the actuation mechanism is sized and configured to move the fluid director.

2. The device of claim 1, wherein the first valve element comprises a head portion and a body portion.

3. The device of claim 2, wherein at least one of the head portion and the body portion comprises at least one notch.

4. The device of claim 2, wherein the body portion comprises a wall defining a chamber, wherein the chamber contains air.

5. The device of claim 4, wherein the first port comprises at least one venting channel in communication with the chamber, the at least one venting channel sized and configured to allow air to move between inside the chamber and outside the chamber.

6. The device of claim 2, wherein the proximal end of the first valve element comprises a first enlarged portion.

7. The device of claim 6, wherein the first valve element comprises a second enlarged portion between the first enlarged portion and the distal end of the first valve element.

8. The device of claim 1, wherein the first valve element is made of an elastomeric material.

9. The device of claim 1, wherein the first port further comprises a valve seat having at least one rib, the first valve element being operably associated with the valve seat.

10. The device of claim 1, wherein the first valve element has a length between about 0.15 inches and about 1.5 inches.

11. The device of claim 10, wherein the first valve element has a length between about 0.4 inches and about 0.6 inches.

12. The device of claim 1, wherein the fluid director comprises a first and second fluid passageway, the first fluid passageway being at an angle relative to the second fluid passageway.

13. The device of claim 12, wherein the fluid director has at least one visual indicator to indicate the orientation of the first and second fluid passage ways relative to at least one of the first, second and third ports.

14. The device of claim 1, wherein the fluid director comprises at least one bore and the actuation mechanism is a toll, the tool being sized and configured to be positionable within the at least one bore.

15. The device of claim 1, wherein the fluid director comprises an outer surface and a recess on the outer surface, and wherein the connecting portion comprises an inner surface and a protrusion on the inner surface, the protrusion being moveable along the recess thereby eliminating axial movement of the fluid director within the connecting portion.

16. The device of claim 1, wherein a portion of the fluid director has a spherical shape.

17. The device of claim 1, wherein the actuation mechanism is a knob.

18. The device of claim 17, further comprising a fourth port through the knob, wherein the fourth port is sized and configured such that fluid flows between the fourth port and the at least one fluid passageway.

19. The device of claim 1, wherein the fluid director is made of a soft material selected from the group consisting of polyethylene, low density polyethylene, linear low density polyethylene, polyester, and polyurethane.

20. The device of claim 1, wherein at least one of the housing, the first valve element, the fluid director and the actuation mechanism comprises an antimicrobial component.

21. The device of claim 1, wherein the connecting portion comprises a limiting portion with a first end and a second end and the fluid director comprises a protrusion, wherein the fluid director is sized and configured to move between a first location, where the protrusion engages the first end of the limiting portion, and a second location, where the protrusion engages the second end of the limiting portion.

22. The device of claim 1, further comprising at least one sleeve positioned on the fluid director, wherein the sleeve is located between the fluid director and the connecting portion.

23. The device of claim 1, wherein the fluid director comprises a wall having a thickness between about 0.005 inches and about 0.060 inches.

24. The device of claim 23, wherein the fluid director comprises a wall having a thickness between about 0.020 inches and about 0.040 inches.

25. The device of claim 1, wherein at least one of the second and third ports has an inner surface, an outer surface, a distal end proximate the connecting portion, a proximal end opposite the distal end, and at least one bonding medium reservoir, the at least one bonding medium reservoir is at least one recess in at least one of the inner surface and the outer surface and extends a length between the proximal end and the distal end of at least one of the second and third ports.

26. The device of claim 1, wherein at least one of the second and third ports comprises:

a central portion having a channel therethrough; and

a wall portion having an inner and outer surface, the inner surface having threads, wherein the wall portion is sized and configured to rotate about the central portion.

27. The device of claim 1, wherein the second port contains a second valve element.

28. The device of claim 27, wherein the third port contains a third valve element.

29. A fluid control device for transferring fluid comprising:

a monolithic housing having a first port, a second port, a third port and a connecting portion connecting the first port, the second port, and the third port;

an access port in the first port for allowing fluid to be injected into the fluid control device, the access port including a first valve element positioned within the first port, the first valve element having a proximal end and a distal end, wherein the first valve element has an opened position allowing fluid to be injected into the fluid control device and a closed position, and wherein the first valve element is sized and configured such that the proximal end of the first valve element is closer to the distal end of the first valve element in the opened position than in the closed position;

a fluid director having at least one fluid passageway, wherein at least a portion of the fluid director is positionable within the connecting portion; and

an actuation mechanism operably associated with the fluid director, wherein the actuation mechanism is sized and configured to move the fluid director.

30. The device of claim 29, wherein the first valve element comprises at least one notch.

31. The device of claim 29, wherein the first valve element comprises a head portion and a body portion.

32. The device of claim 31, wherein the body portion comprises a wall defining a chamber, the chamber containing air.

33. The device of claim 32, wherein the first port comprises at least one venting channel in communication with the chamber, the at least one venting channel sized and configured to allow air to move between inside the chamber and outside the chamber.

34. The device of claim 33, wherein the first valve element has a length between about 0.3 inches and about 1.5 inches.

35. The device of claim 34, wherein the first valve element has a length between about 0.55 inches and about 0.75 inches.

36. The device of claim 29, wherein the actuation mechanism is a knob, and wherein the fluid director is sized and configured such that movement of the knob results in movement of the fluid director.

37. The device of claim 36, further comprising a fourth port through the knob, wherein the fourth port is sized and configured so that fluid flows between the fourth port and the at least one passageway.

38. The device of claim 37, wherein the fourth port is sized and configured to rotate relative to the knob.

39. The device of claim 29, wherein the connecting portion comprises a limiting portion with a first end and a second end, and the fluid director comprises a protrusion, wherein the fluid director is sized and configured to move between a first location, where the protrusion engages the first end of the limiting portion, and a second location, where the protrusion engages the second end of the limiting portion.

40. A method of transferring fluid comprising:

providing a fluid control device comprising;

a monolithic housing having a first port, a second port, a third port, and a connecting portion connecting the first, second and third ports, the first port having a longitudinal axis;

a needleless access device incorporated into the first port, the needleless access device including a first valve element having an axis;

a fluid director having at least one fluid passageway, wherein the fluid director is positionable within the connecting portion; and

an actuation mechanism operably associated with the fluid director;

inserting a first fluid transfer device into the needleless access device such that the first valve element moves from a first position, where the axis of the first valve element is parallel with the longitudinal axis of the first port, to a second position, where the axis of the first valve element is displaced from the longitudinal axis of the first port thereby permitting fluid to flow from the first fluid transfer device into the fluid control device;

moving the fluid director in the connecting portion using the actuation mechanism; and

aligning the at least one fluid passageway with at least two of the first, second and third ports.

41. The method of claim 40, wherein the first valve element comprises a wall defining a chamber containing air, and the first port comprises at least one venting channel, the method further comprising:

moving air out of the chamber and through the at least one venting channel as the first valve element moves from the first position to the second position.

42. The method of claim 40, wherein the connecting portion comprises a limiting portion with a first end and a second end and the fluid director comprises a protrusion, wherein the step of moving the fluid director comprises rotating the fluid director between a first location, where the protrusion engages the first end of the limiting portion, and a second location, where the protrusion engages the second end of the limiting portion.

43. The method of claim 40 further comprising:

engaging a second fluid transfer device with the second port; and

engaging a third fluid transfer device with the third port.

44. The method of claim 43, wherein at least one of the second and third ports comprises an elongated central portion having a channel and a wall portion positioned around the elongated central portion, the wall portion having threads, the method further comprising rotating the wall portion on the elongated central portion so that the threads of the wall portion engage a threaded portion of at least one of the second and third fluid transfer devices.

45. A method of transferring fluid comprising:

providing a fluid control device comprising;

a monolithic housing having a first port, a second port, a third port, and a connecting portion connecting the first, second and third ports;

a needleless access device incorporated into the first port and including a first valve element having an outer surface, a proximal end, a distal end, an opened position and a closed position, the first valve element being positioned within the needleless access device;

a fluid director having at least one fluid passageway, wherein at least a portion of the fluid director is positionable within the housing; and

an actuation mechanism operably associated with the fluid director;

inserting a first fluid transfer device into the needleless access device such that the proximal end of the first valve element moves towards the distal end of the first valve element;

moving the fluid director in the housing the actuation mechanism;

aligning the at least one fluid passageway with at least two of the first, second and third ports; and

allowing fluid to flow around the outer surface of the first valve element.

46. The method recited in claim 45, further comprising the step of:

transferring fluid through at least one of the second and third ports in at least one of a first direction out of the fluid control device and a second direction into the fluid control device;

wherein the first valve element causes movement of fluid through at least one of the second and third ports in the second direction in response to movement of the first valve element from the closed position to the opened position, and wherein the first valve element causes movement of fluid through at least one of the second and third ports in the first direction in response to movement of the first valve element from the opened position to the closed position.