Swabbable luer-activated valve

• US 6,039,302 A
• Filed: 09/13/1999
• Issued: 03/21/2000
• Est. Priority Date: 11/18/1996
• Status: Expired due to Term

• Current Assignee: NP Medical Inc. (Jabil Inc.)
• Original Assignee: Nypro Incorporated (Jabil Inc.)
• Inventors: Ganem, Charles F., Cote, Andrew L. Sr.
• Primary Examiner(s): LEE, KEVIN L
• Application Number:
  US09/394,169
• Time in Patent Office: 190 Days
• Field of Search: 251/149.1, 604/256, 604/283, 604/167, 604/169, 604/905
• US Class Current: 251/149.1
• CPC Class Codes: A61M 2039/261 where the fluid space within the valve is increasing upon disconnection
• 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 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2039/268 wherein the stem portion is moved for opening and closing the valve, e.g. by translation, rotation
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A normally closed valve that may be opened upon insertion of a nozzle permits two-way flow when opened by a luer-taper nozzle. The valve also is able to resist large back pressures. The valve includes a substantially rigid housing that defines a passageway having an inlet section and an outlet section. The housing has an exterior inlet face to which the inlet section opens. The inlet section preferably has tapered and expanding zones. The tapered zone is adjacent to the exterior inlet face and is shaped to receive the nozzle. The expanding zone is adjacent to the tapered zone and has a larger inner diameter than the tapered zone'"'"'s inner diameter. The exterior of the inlet section of the housing may have threads to accept luer-lock threads that may surround the nozzle.

Claims

1. A normally closed valve that may be opened upon insertion of a luer-tapered nozzle, the valve comprising:

a housing defining a passageway having an inlet section and an outlet section, the housing being substantially rigid and having an exterior inlet face to which the inlet section opens;

a substantially rigid cannula disposed within the passageway and extending into the inlet section, the cannula being movable between first and second positions corresponding to closed and open modes of the valve, the cannula having an inlet end and an outlet end;

a substantially flexible, resilient gland member having

a seal section disposed over the inlet end of the cannula, the seal section having a normally closed aperture therethrough,

a tubular section connected to the seal section and disposed around the cannula between cannula and the housing, and

an attachment section connected to the tubular section and attached to the housing;

wherein, when the valve is in its closed mode, the seal section is substantially aligned with the exterior inlet face of the housing so as to provide a swabbable surface.

2. A valve according to claim 1, wherein the inlet end of the cannula and the gland are shaped to permit a length of travel of the seal section with respect to the cannula, and wherein the valve includes means for restricting movement of the seal section through the inlet section beyond the length of travel.

3. A valve according to claim 2, wherein the inlet end of the cannula is spaced away from the seal section when the valve is in its closed mode.

4. A valve according to claim 3, wherein the inlet section of the housing'"'"'s passageway has

a tapered zone adjacent the exterior inlet face and being shaped to receive the nozzle, and

an expanding zone adjacent to the tapered zone and having a greater inner diameter than the tapered zone'"'"'s inner diameter,

wherein the gland member'"'"'s seal section has an outer diameter that is larger than the tapered zone'"'"'s inner diameter and smaller then the expanding zone'"'"'s inner diameter, and

wherein, the seal section'"'"'s aperture opens after the nozzle presses the seal section past the tapered zone into the expanding zone of the inlet section.

5. A valve according to claim 4, wherein the outlet end of the cannula is shaped so as to provide a back-pressure seal with the gland member.

6. A valve according to claim 5, wherein the tubular section of the gland member is under compression when the valve is fully closed.

7. A valve according to claim 6, wherein the exterior of the inlet section of the housing has threads to accept luer-lock threads surrounding a nozzle.

8. A valve according to claim 7, wherein the attachment section of the gland member is stretched as the valve is urged by the nozzle from the valve'"'"'s closed mode to the valve'"'"'s opened mode.

9. A valve according to claim 8, wherein the tubular section of the gland member is further compressed as the valve is urged by the nozzle from the valve'"'"'s closed mode to the valve'"'"'s opened mode.

10. A valve according to claim 9, wherein the housing includes gland-stopping structure for stopping movement of the gland towards the outlet section of the valve independently of movement of the cannula.

11. A valve according to claim 10, further including a cannula-stopping structure for stopping movement of the cannula towards the outlet section of the valve while permitting flow to the outlet section of the valve.

12. A valve according to claim 10, wherein the housing includes a rigid annular member disposed between the gland member'"'"'s attachment section and the gland member'"'"'s tubular section.

13. A valve according to claim 12, wherein the gland member'"'"'s attachment section includes a flexible wiper member, located at the attachment section'"'"'s outlet end, for maintaining contact between the attachment section and the housing at the attachment section outlet end.

14. A valve according to claim 13, wherein the gland member'"'"'s attachment section includes a vent port.

15. A valve according to claim 14, wherein the housing includes a vent in the inlet section.

16. A valve according to claim 7, wherein the outlet end of the cannula is shaped to provide a flexible member that urges the cannula into the first position.

17. A valve according to claim 2, wherein the inlet end of the cannula is shaped to urge the seal section open.

18. The valve according to claim 1 wherein the outlet end of the cannula has a tapering outer diameter and ribs.

19. The valve according to claim 1 wherein the passageway is defined in part by an inner wall, the inner wall being free of ribs.

20. The valve according to claim 1 wherein the gland includes a ridge and the passageway is defined in part by a ledge, wherein the ridge is seated on the ledge.

21. The valve according to claim 1 wherein the passageway is defined in part by a ledge, the gland being seated on the ledge during both the closed mode and the open mode.

22. A normally closed valve that may be opened upon insertion of a luer-tapered nozzle, the valve comprising:

a housing defining a passageway having an inlet section and an outlet section, the housing being substantially rigid and having an exterior inlet face to which the inlet section opens;

a substantially rigid cannula disposed within the passageway and extending into the inlet section, the cannula being movable between first and second positions corresponding to closed and open modes of the valve, the cannula having an inlet end and an outlet end;

a substantially flexible, resilient gland member having

a seal section disposed over the inlet end of the cannula, the seal section having a normally closed aperture therethrough, and

a tubular section connected to the seal section and disposed around the cannula between cannula and the housing,

wherein the outlet end of the cannula is shaped so as to provide a back-pressure seal with the gland member, and

wherein, when the valve is in its closed mode, the seal section is substantially aligned with the exterior inlet face of the housing so as to provide a swabbable surface.

23. A valve according to claim 22, wherein the tubular section of the gland member is under compression when the valve is fully closed.

24. A valve according to claim 23, wherein the tubular section of the gland member is further compressed as the valve is urged by the nozzle from the valve'"'"'s closed mode to the valve'"'"'s opened mode.

25. A valve according to claim 24, wherein the housing includes gland-stopping structure for stopping movement of the gland towards the outlet section of the valve independently of movement of the cannula.

26. A valve according to claim 25, further including a cannula-stopping structure for stopping movement of the cannula towards the outlet section of the valve while permitting flow to the outlet section of the valve.

27. A valve according to claim 26, wherein the inlet section of the housing'"'"'s passageway has

a tapered zone adjacent the exterior inlet face and being shaped to receive the nozzle, and

an expanding zone adjacent to the tapered zone and having a greater inner diameter than the tapered zone'"'"'s inner diameter,

wherein the gland member'"'"'s seal section has an outer diameter that is larger than the tapered zone'"'"'s inner diameter and smaller than the expanding zone'"'"'s inner diameter, and

wherein, the seal section'"'"'s aperture opens after the nozzle presses the seal section past the tapered zone into the expanding zone of the inlet section.

28. A valve according to claim 27, wherein the exterior of the inlet section of the housing has threads to accept luer-lock threads surrounding a nozzle.

29. A valve according to claim 22 wherein the outlet end of the cannula includes a rib.

30. The valve according to claim 22 wherein the gland includes a ridge and the passageway is defined in part by a ledge, wherein the ridge is seated on the ledge.

31. The valve according to claim 22 wherein the passageway is defined in part by a ledge, the gland being seated on the ledge during both the closed mode and the open mode.

32. A normally closed valve that may be opened upon insertion of a luer-tapered nozzle, the valve comprising:

a housing defining a passageway having an inlet section and an outlet section, the housing being substantially rigid and having an exterior inlet face to which the inlet section opens;

a substantially rigid cannula disposed within the passageway and extending into the inlet section, the cannula being movable between first and second positions corresponding to closed and open modes of the valve, the cannula having an inlet end and an outlet end;

a substantially flexible, resilient gland member having

a seal section disposed over the inlet end of the cannula, the seal section having a normally closed aperture therethrough, and

a tubular section connected to the seal section and disposed around the cannula;

wherein the inlet section of the housing'"'"'s passageway has

a tapered zone adjacent the exterior inlet face and being shaped to receive the nozzle, and

an expanding zone adjacent to the tapered zone and having a greater inner diameter than the tapered zone'"'"'s inner diameter;

wherein the gland member'"'"'s seal section has an outer diameter that is larger than the tapered zone'"'"'s inner diameter and smaller than the expanding zone'"'"'s inner diameter, and

wherein the seal section'"'"'s aperture opens after the nozzle presses the seal section past the tapered zone into the expanding zone of the inlet section,

wherein, when the valve is in its closed mode, the seal section is substantially aligned with the exterior inlet face of the housing so as to provide a swabbable surface.

33. A valve according to claim 32 wherein the inlet end of the cannula and the gland are shaped to permit a length of travel of the seal section with respect to the cannula.

34. A valve according to claim 33, wherein the inlet end of the cannula is shaped to urge the seal section open.

35. A valve according to claim 33, further including means for restricting movement of the seal section through the inlet section beyond the length of travel.

36. A valve according to claim 35, wherein the inlet end of the cannula is shaped to urge the seal section open.

37. A valve according to claim 35, wherein the inlet end of the cannula is spaced away from the seal section when the valve is in its closed mode.

38. A valve according to claim 37, wherein the outlet end of the cannula is shaped so as to provide a back-pressure seal with the gland member.

39. A valve according to claim 38, wherein the cannula includes a ledge disposed between the step and the cannula'"'"'s outlet end, and the tubular section has a subsection, adjacent the seal section, shaped to correspond to the ledge, so as to prevent movement of the cannula'"'"'s ledge past the tubular section'"'"'s shaped subsection.

40. A valve according to claim 39, wherein the tubular section of the gland member is under compression when the valve is fully closed.

41. A valve according to claim 40, wherein the tubular section of the gland member is further compressed as the valve is urged by the nozzle from the valve'"'"'s closed mode to the valve'"'"'s opened mode.

42. A valve according to claim 41, wherein the housing includes gland-stopping structure for stopping movement of the gland towards the outlet section of the valve independently of movement of the cannula.

43. A valve according to claim 42, further including a cannula-stopping structure for stopping movement of the cannula towards the outlet section of the valve while permitting flow to the outlet section of the valve.

44. A valve according to claim 43, wherein the gland member further includes an attachment section connected to the tubular section and attached to the housing.

45. A valve according to claim 44, wherein the attachment section of the gland member is stretched as the valve is urged by the nozzle from the valve'"'"'s closed mode to the valve'"'"'s opened mode.

46. A valve according to claim 45, wherein the housing includes a rigid annular member disposed between the gland member'"'"'s attachment section and the gland member'"'"'s tubular section.

47. A valve according to claim 46, wherein the gland member'"'"'s attachment section includes a flexible wiper member, located at the attachment section'"'"'s outlet end, for maintaining contact between the attachment section and the housing at the attachment section outlet end.

48. A valve according to claim 41, wherein the outlet end of the cannula is shaped to provide a flexible member that urges the cannula into the first position.

49. A valve according to claim 32, wherein the exterior of the inlet section of the housing has threads to accept luer-lock threads surrounding a nozzle.

50. The valve according to claim 32 wherein the outlet end of the cannula has a tapering outer diameter and ribs.

51. The valve according to claim 32 wherein the passageway is defined in part by an inner wall, the inner wall being free of ribs.

52. The valve according to claim 32 wherein the gland includes a ridge and the passageway is defined in part by a ledge, wherein the ridge is seated on the ledge.

53. The valve according to claim 32 wherein the passageway is defined in part by a ledge, the gland being seated on the ledge during both the closed mode and the open mode.

54. A normally closed valve that may be opened upon insertion of a luer-tapered nozzle, the valve comprising:

a housing defining a passageway having an inlet section and an outlet section, the housing being substantially rigid and having an exterior inlet face to which the inlet section opens;

a substantially rigid cannula disposed within the passageway and extending into the inlet section, the cannula being movable between first and second positions corresponding to closed and open modes of the valve, the cannula having an inlet end and an outlet end, wherein the cannula'"'"'s shape remains constant as the cannula is moved between first and second positions;

a substantially flexible, resilient gland member having

a seal section disposed over the inlet end of the cannula, the seal section having a normally closed aperture therethrough, and

a tubular section connected to the seal section and disposed around the cannula between cannula and the housing;

wherein, when the valve is in its closed mode, the seal section is substantially aligned with the exterior inlet face of the housing so as to provide a swabbable surface.

55. The valve according to claim 54 wherein the outlet end of the cannula has a tapering outer diameter and ribs.

56. The valve according to claim 54 wherein the passageway is defined in part by an inner wall, the inner wall being free of ribs.

57. The valve according to claim 54 wherein the gland includes a ridge and the passageway is defined in part by a ledge, wherein the ridge is seated on the ledge.

58. The valve according to claim 54 wherein the passageway is defined in part by a ledge, the gland being seated on the ledge during both the closed mode and the open mode.

59. A normally closed valve that may be opened upon insertion of a luer-tapered nozzle, the valve comprising:

a housing defining a passageway having an inlet section and an outlet section, the housing being substantially rigid and having an exterior inlet face to which the inlet section opens;

a substantially rigid cannula disposed within the passageway and extending into the inlet section, the cannula being movable between first and second positions corresponding to closed and open modes of the valve, the cannula having an inlet end and an outlet end;

a substantially flexible, resilient gland member having

a seal section disposed over the inlet end of the cannula, the seal section having a normally closed aperture therethrough, and

a tubular section connected to the seal section and disposed around the cannula between cannula and the housing;

wherein, when the valve is in its closed mode, the seal section is substantially aligned with the exterior inlet face of the housing so as to provide a swabbable surface, and

wherein the inlet end of the cannula and the gland are shaped to permit a length of travel of the seal section with respect to the cannula.

60. A valve according to claim 59, wherein the valve includes means for restricting movement of the seal section through the inlet section beyond the length of travel.

61. A valve according to claim 60, wherein the inlet end of the cannula is spaced away from the seal section when the valve is in its closed mode.

62. A valve according to claim 61, wherein the inlet section of the housing'"'"'s passageway has

a tapered zone adjacent the exterior inlet face and being shaped to receive the nozzle, and

an expanding zone adjacent to the tapered zone and having a greater inner diameter than the tapered zone'"'"'s inner diameter,

wherein the gland member'"'"'s seal section has an outer diameter that is larger than the tapered zone'"'"'s inner diameter and smaller than the expanding zone'"'"'s inner diameter, and

wherein, the seal section'"'"'s aperture opens after the nozzle presses the seal section past the tapered zone into the expanding zone of the inlet section.

63. A valve according to claim 59, wherein the seal section remains entirely between the cannula and the exterior inlet face when the valve is open.

64. A valve according to claim 59, wherein the inlet end of the cannula is shaped to urge the seal section open.

65. The valve according to claim 59 wherein the outlet end of the cannula has a tapering outer diameter and ribs.

66. The valve according to claim 59 wherein the passageway is defined in part by an inner wall, the inner wall being free of ribs.

67. The valve according to claim 59 wherein the gland includes a ridge and the passageway is defined in part by a ledge, wherein the ridge is seated on the ledge.

68. The valve according to claim 59 wherein the passageway is defined in part by a ledge, the gland being seated on the ledge during both the closed mode and the open mode.

69. A medical valve comprising:

a housing defining a passageway, the passageway having an inlet section and an outlet section;

a substantially rigid cannula movably mounted within the passageway; and

a substantially flexible, resilient gland member secured to the housing and the cannula, the cannula being supported within the passageway by the gland member.

70. The valve as defined by claim 69 wherein the cannula is adapted to move between a first position corresponding to a closed mode and a second position corresponding to an open mode.

71. The valve as defined by claim 69 wherein the passageway includes:

an inlet;

a first section that converges from the inlet section;

a second section that diverges from the first section; and

a third section that diverges from the second section.

72. A medical valve having an open mode and a closed mode, the valve comprising:

a housing defining a passageway;

a rigid cannula mounted within the passageway, the cannula having an inlet end and a sealing end, the sealing end formed to substantially seal the passageway when in the closed mode; and

a substantially flexible, resilient gland member having a seal disposed over the inlet end of the cannula.

73. The valve as defined by claim 72 wherein the rigid cannula is movable within the passageway between the closed mode and the open mode, the sealing end of the cannula formed to enable liquid to pass through the passageway when in the open mode.

74. A medical valve for use with a luer-tapered nozzle, the valve comprising:

a housing defining a passageway having a tapered section with an inlet port, the passageway also having an expanding section;

a cannula mounted within the passageway and having an inlet; and

a substantially flexible, resilient gland member having a seal section disposed over the inlet of the cannula, the seal section having a normally closed aperture therethrough;

the seal section being movable through the passageway between the tapered section of the passageway and expanding section of the passageway,

the aperture being substantially closed when the seal section is disposed in the inlet port,

the aperture being open when the seal section is disposed in the expanding section.