Catheter with removable extension

• US 20050256461A1
• Filed: 11/12/2004
• Published: 11/17/2005
• Est. Priority Date: 05/12/2004
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: DiFiore, Attilio E., Rome, Guy
• Granted Patent: US 7,347,853 B2
• Time in Patent Office: Days
• US Class Current: 604/247
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 2039/1083 having a plurality of female connectors, e.g. Luer connectors
• CPC Class Codes: A61M 2039/1088 having a plurality of male connectors, e.g. Luer connectors
• CPC Class Codes: A61M 2039/1094 at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection
• 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 25/0075 Valve means
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/105 Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes multi-channel connectors in general F16L37/56
• 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

Catheter valve assemblies and methods for connecting catheters and/or providing fluid access to catheters. In one variation, a device comprises a catheter valve assembly and an extension leg unit. The extension leg unit includes lumen inserts for engaging valves positioned within the catheter valve assembly. In another variation, the valve assembly comprises a depressable plunger which may be engaged by an access cannula. Various connectors with integrated valve assemblies are also disclosed.

Claims

1. A catheter device comprising:

a catheter valve assembly comprising a housing surrounding a lumen, and a valve positioned in the lumen; and

an extension leg unit comprising a lumen insert and an extension leg, the lumen insert being in fluid communication with the extension leg, the lumen insert being configured to engage the catheter valve assembly, the valve being opened by connecting a distal end of the extension leg unit to a proximal end of the catheter valve assembly, and the valve being closed by disconnecting the extension leg unit from the catheter valve assembly.

2. The catheter device according to claim 1, wherein the catheter valve assembly further comprising a catheter including a lumen, wherein a proximal portion of the catheter forms the housing and the valve is positioned within the lumen of the catheter.

3. The catheter device according to claim 2, wherein the extension leg unit further comprising an extension tubing connected to the extension leg.

4. The catheter device according to claim 1, further comprising a catheter extending from a distal end of the catheter valve assembly.

5. The catheter device according to claim 4, wherein the catheter valve assembly is integrated within the lumen of the catheter.

6. The catheter device according to claim 4, wherein the catheter comprising a plurality of lumens.

7. The catheter interconnecting assembly according to claim 1, wherein the valve comprising a unidirectional valve.

8. The catheter device according to claim 1, wherein the catheter valve assembly comprising a housing surrounding a plurality of lumens, each of the plurality of lumens including a valve positioned therein, and wherein the extension leg unit comprising a plurality of lumen inserts and a plurality of extension legs.

9. The catheter device according to claim 8, wherein each of the plurality of extension legs including a corresponding lumen insert.

10. The catheter device according to claim 8, wherein each of the plurality of lumen inserts is configured to contact and force open at least one of the valves when the extension leg unit engages the catheter valve assembly.

11. The catheter device according to claim 10, wherein a first coupling interface is provided at the distal end of the extension leg unit, and a second coupling interface is provided at the proximal end of the catheter, valve assembly, wherein the first and second coupling interfaces are configured for interlocking connection to each other.

12. The catheter device according to claim 11, wherein the first and second coupling interfaces comprising a male and a female luer connection.

13. The catheter device according to claim 10, further comprising a catheter including a plurality of lumens and extending from the distal end of the catheter valve assembly.

14. The catheter device according to claim 13, further comprising a plurality of extension tubings, wherein each of the plurality of extension tubings is connected to one of the plurality of extension legs on the extension leg unit.

15. The catheter device according to claim 13, wherein each of the plurality of valves comprising a duck-bill valve.

16. The catheter device according to claim 13, wherein each of the plurality of valves comprising a bi-leaf valve.

17. The catheter device according to claim 13, wherein each of the plurality of valves comprising a spring-loaded valve.

18. The catheter device according to claim 13, wherein each of the plurality of valves comprising a unidirectional valve.

19. The catheter device according to claim 13, wherein the cross-sectional area of the catheter valve assembly is approximately equivalent to the cross-sectional area of a longitudinal mid-point of the catheter.

20. A catheter comprising:

an elongated tubing including a plurality of lumens;

a plurality of valves, each of the plurality of lumens including a valve positioned at a proximal end of the lumen; and

a fluid interconnector comprising a plurality of lumen inserts extending from the distal end of the fluid interconnector, each of the lumen inserts being configured to insert into a proximal portion of one of the plurality of lumens, the plurality of lumen inserts being further configured to engage the plurality of valves and force the valves open when the lumen inserts are positioned inside the lumens, the plurality of valves remaining closed when the lumen inserts are removed.

21. The catheter according to claim 20, wherein the fluid interconnector further comprising a plurality of branches, each of the plurality of branches supporting a fluid pathway to one of the plurality of lumen inserts.

22. The catheter according to claim 21, further comprising a plurality of extension tubings, each of the branches being connected to one of the plurality of extension tubings.

23. The catheter according to claim 21, wherein each of the plurality of valves comprising an unidirectional valve.

24. The catheter according to claim 21, wherein the elongated tubing including two lumens, each of the lumens including a valve, and the fluid interconnector comprising two lumen inserts and two branches.

25. The catheter according to claim 24, further comprising a coupling lock that detachably locks the distal end of the fluid interconnector to the proximal end of the elongated tubing.

26. The catheter according to claim 21, further comprising a pair of corresponding locking interfaces integrated on the proximal end of the elongated tubing and the distal end of the fluid interconnector for connecting the interconnector with the elongated tubing.

27. The catheter according to claim 20, wherein each of the valves comprising a unidirectional valve.

28. The catheter according to claim 24, wherein each of the valves comprising a duck-bill valve.

29. The catheter according to claim 22, wherein each of the valves comprising a bi-leaf valve.

30. The catheter according to claim 20, wherein the catheter is configured to permit insertion of an introducer through one of the catheter lumens.

31. The catheter according to claim 20, wherein the proximal end of the catheter is configured with a profile that allows reverse tunneling of the catheter.

32. The catheter according to claim 20, wherein the distal end of the interconnector is configured as a male luer interface for connection to a proximal end of the elongated tubing.

33. The catheter according to claim 20, wherein the plurality of valves prevents retrograde flow through the catheter.

34. The catheter according to claim 21, wherein the catheter is configured to support a flow rate of at least 200 ml/min in each of the lumens.

35. The catheter according to claim 21, wherein the catheter is configured to support a flow rate of at least 400 ml/min in each of the lumens.

36. The catheter according to claim 21, further comprising a porous mesh or filter positioned within at least one of the fluid pathways.

37. The catheter according to claim 21, wherein the fluid interconnector further comprising a porous mesh or filter positioned within at least one of the plurality of branches.

38. The catheter according to claim 24, wherein each of the catheter lumen including a D-shaped cross-section.

39. The catheter according to claim 38, wherein each of the valves comprising a unidirectional valve.

40. A catheter connector comprising:

a valve assembly comprising a housing with at least one chamber, the housing including a proximal opening and a distal port, a spring-loaded plunger is positioned at the proximal opening, and a septum is positioned within the housing and around the proximal opening for providing a seal around the spring-loaded plunger when the spring load plunger is displaced towards the proximal opening; and

an access cannula with at least one lumen, the access cannula being configured with a blunt distal end and at least one side orifice for accessing the at least one lumen, the access cannula being further configured to engage the spring-loaded plunger and establishes fluid communication between the chamber in the housing and the lumen in the cannula.

41. The catheter connector according to claim 40, further comprising a first catheter connected to the distal port of the housing and a second catheter connected to a proximal end of the access cannula.

42. The catheter connector according to claim 40, wherein the housing comprising two chambers and two corresponding distal ports, and wherein the access cannula comprising two lumens, each of the lumens including at least one corresponding side orifice.

43. The catheter connector according to claim 42, wherein the valve assembly further comprising a sealing disk slidably disposed along the length of the spring-loaded plunger, and the sealing disk is configured with two channels for fluid flow to pass through.

44. The catheter connector according to claim 40, wherein the valve assembly further comprising a sealing disk slidably disposed along the length of the spring-load plunger.

45. The catheter connector according to claim 44, wherein the valve assembly further comprising a spring configured to compress the sealing disk against the septum.

46. The catheter connector according to claim 45, wherein the spring is positioned between the spring-loaded plunger and the sealing disk.

47. The catheter connector according to claim 44, wherein the distal end of the cannula is configured to engage the sealing disk.

48. The catheter connector according to claim 40, further comprising an enclosure attached to, and positioned around, the access cannula.

49. The catheter connector according to 48, wherein the enclosure further comprising a locking mechanism for securing the enclosure to the valve assembly.

50. The catheter connector according to claim 48, wherein the enclosure further comprising a latch for securing the enclosure to the valve assembly.

51. The catheter connector according to claim 40, wherein the septum is configured with one or more fluid paths.

52. The catheter connector according to claim 40, wherein the septum extends distally and covers a side wall of the chamber.

53. The catheter connector according to claim 40, wherein the housing comprising three chambers and three corresponding distal ports, and the access cannula comprises three lumens wherein each of the lumens including at least one corresponding side orifice.

54. The catheter connector according to claim 40, wherein the blunt distal end of the cannula is configured with a recess to receive at least part of the spring-loaded plunger.

55. A multi-lumen catheter connector, comprising:

a housing comprising a first chamber in fluid communication with a first port, a second chamber in fluid communication with a second port, and a proximal opening for accessing the first and second chamber;

a depressible valve configured to seal the proximal opening; and

a multi-lumen cannula configured to insert into the proximal opening of the housing, the cannula including a closed distal end, a first orifice on a circumferential surface of the cannula for accessing a first lumen, and a second orifice on a circumferential surface of the cannula for accessing a second lumen, such that when the cannula is inserted into the proximal opening of the housing, the distal end of the cannula engages the depressible valve and fluid communication is established between the first lumen and the first port, and between the second lumen and the second port.

56. The multi-lumen connector according to claim 55, further comprising a septum positioned on an inner surface of the housing around the proximal opening.

57. The multi-lumen connector according to claim 56, wherein the depressible valve comprisings a spring-loaded plunger.

58. The multi-lumen connector according to claim 55, further comprising a sealing disk slidably disposed within the housing, the sealing disk being configured to prevent the proximal opening from accessing the first and second chambers when the depressible valve is depressed without engaging the sealing disk.

59. The multi-lumen connector according to claim 58, wherein the distal end of the cannula is configured to engage the sealing disk when the cannula is inserted into the proximal opening of the housing.

60. The multi-lumen connector according to claim 58, further comprising a spring positioned within the housing being configured to compress the sealing disk against the septum.

61. The multi-lumen connector according to claim 60, wherein the sealing disk comprising a first channel corresponding to the first chamber and a second channel corresponding to the second chamber.

62. The multi-lumen connector according to claim 55, further comprising an adapter connected to the multi-lumen cannula, the adapter being configured to orient the cannula within the proximal opening when the adapter engages the housing such that the first orifice aligns with the fist chamber and the second orifice aligns with the second chamber.

63. The multi-lumen connector according to claim 62, further comprising a latch configured to secure the adapter to the housing when the adapter engages the housing.

64. The multi-lumen connector according to claim 55, wherein at least one of the first and second chamber is configured to accommodate the passage of a guidewire.

65. The multi-lumen connector according to claim 55, further comprising a removable cap with a single lumen cannula for engaging the depressible valve and a polymeric valve positioned at a proximal end of the single lumen cannula.

66. The multi-lumen connector according to claim 65, wherein the polymeric valve comprising a closed proximal end with a slit and an hourglass-shaped lumen.

67. The multi-lumen connector according to claim 55, further comprising a multi-lumen catheter with its proximal end connected to the first and second ports.

68. The multi-lumen connector according to claim 62, further comprising a multi-lumen catheter with its distal end connected to a proximal end of the adapter.

69. A single lumen catheter connector, comprising:

a housing including a proximal end opening for accessing a chamber within the housing and a channel connecting the chamber to a port at the distal end of the housing;

a tubing positioned within the chamber, the tubing being configured with a closed proximal end and an orifice located on a circumferential surface thereof for accessing a lumen within the tubing, the lumen being in fluid communication with the channel; and

a compressible seal positioned within the chamber, and surrounding the tubing.

70. The single lumen catheter connector according to claim 69, further comprising a cannula including a tapered distal end configured to insert into the proximal end opening and over the tubing, such that fluid communication is established between the lumen of the tubing and a lumen of the cannula.

71. The single lumen catheter connector according to claim 70, wherein the tubing including an outer diameter that is smaller than an inner diameter of the cannula.

72. The single lumen catheter connector according to claim 70, wherein the tubing comprising two oval-shaped orifices located on opposing sides of the tubing.

73. The single lumen catheter connector according to claim 70, wherein a space is provided between the compressible seal and a wall of the chamber, such that when the cannula is inserted into the proximal end opening, at least portion of the compressible seal is displaced into the space.

74. The single lumen catheter connector according to claim 70, further comprising a catheter connected to the distal end of the housing.

75. A method of establishing fluid communication with a catheter comprising:

inserting at least a first lumen insert and a second lumen insert into a proximal end of the catheter;

displacing a first unidirectional valve within a first lumen of the catheter, and a second unidirectional valve within a second lumen of the catheter; and

establishing fluid communication through the first and the second lumen inserts into the first and the second lumens of the catheters.

76. The method according to claim 75 wherein the first and the second unidirectional valves each comprising a duck-bill valve.

77. The method according to claim 75 wherein the first and the second unidirectional valves each comprising a bi-leaf valve.

78. The method according to claim 75 wherein a dual lumen extension catheter is in fluid communication with the first and the second lumen inserts.

79. The method according to claim 78 further comprising:

connecting a hemodialysis machine to a proximal end of the dual lumen extension catheter.

80. The method according to claim 75 wherein a proximal portion of the first and the second lumen inserts are connected to a distal end of a housing, the proximal end of the housing comprising a first leg extension in fluid communication with the firs lumen insert, and a second leg extension in fluid communication with the second lumen insert.

81. The method according to claim 75 further comprising:

removing the lumen inserts from the proximal end of the catheter and allowing the unidirectional valves to close by themselves.

82. A method of making a connection to a catheter comprising:

inserting a cannula into a valve assembly positioned at a proximal end of the catheter, the cannula comprising at least a first cannula lumen and a second cannula lumen, the catheter further comprising at least a first catheter lumen and a second catheter lumen;

displacing a valve positioned within the valve assembly; and

establishing fluid communication between the first catheter lumen and the first cannula lumen through a first orifice located on a circumferential surface of the cannula, and between the second catheter lumen and the second cannula lumen through a second orifice located on the circumferential surface of the cannula.

83. The method according to claim 82 wherein the displacing act further comprising displacing a safety sealing disk positioned within the valve assembly.

84. The method according to claim 82 further comprising:

injecting a fluid through the first cannula lumen and the first catheter lumen into a patient'"'"'s circulatory system; and

aspirating a blood fluid from the circulatory system through the second catheter lumen and second cannula lumen.

85. The method according to claim 82 wherein the cannula including a blunt distal end configured to displace the valve.

86. The method according to claim 85 wherein the valve comprising a spring-loaded plunger.

87. The method according to claim 82 further comprising:

removing the cannula from the valve assembly and allowing the valve to close by itself.

88. A catheter assembly comprising:

an elongated catheter, the catheter comprising a plurality of lumens, each of the lumens including a unidirectional valve located at a proximal portion of the elongated catheter; and

means for simultaneously engaging the unidirectional valves and keeping the unidirectional valves open.

89. The catheter assembly according to claim 88 further comprising:

means for aspirating blood from a patient'"'"'s circulatory system through a first one of the plurality of lumens, processing the aspirated blood, and injecting processed blood back into the circulatory system through a second one of the plurality of lumens.

90. The catheter assembly according to claim 88 wherein each of the unidirectional valves comprising a duck-bill valve.

91. The catheter assembly according to claim 88 wherein each of the unidirectional valves comprising a bi-leaf valve.

92. A fluid delivery apparatus comprising:

a multi-lumen catheter assembly, a proximal end of the catheter assembly comprising means for sealing the proximal end of the catheter assembly when the proximal end of the catheter assembly is not engaged; and

means for engaging the proximal end of the catheter assembly and establishing a fluid communication through the catheter assembly.

93. The fluid delivery system according to claim 92 further comprising:

means for simultaneously injecting and aspirating fluids from a patient'"'"'s circulatory system through the multi-lumen catheter assembly.

94. The fluid delivery system according to claim 92 further comprising:

means for performing hemodialysis on a patient through the multi-lumen catheter assembly.