Methods and systems for establishing vascular access

• US 5,931,829 A
• Filed: 05/15/1997
• Issued: 08/03/1999
• Est. Priority Date: 01/21/1997
• Status: Expired due to Term

• Current Assignee: Vasca Inc.
• Original Assignee: Vasca Inc.
• Inventors: Brugger, James M., Burbank, Jeffrey H., Finch, Charles D., Beathard, Gerald, Buffaloe, George W.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US08/856,641
• Time in Patent Office: 810 Days
• Field of Search: 604/93, 604/264, 604/280, 604/4, 604/49-53
• US Class Current: 604/502
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2205/195 by the needle tip shape
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A body lumen access system comprises a distal access cannula and a proximal access cannula. The distal access cannula is attached to or within the body lumen and the proximal access cannula is attached to an implantable port or is transcutaneously positioned and attached to a luer or other external connector. The distal and proximal access cannulas are usually implanted separately, cut to length, and attached at a subcutaneous junction location. Preferably, the proximal access cannula has a larger lumen diameter than that of the distal access cannula in order to reduce flow resistance within the cannula system. In some cases the distal and proximal access cannulas may be formed integrally.

Claims

1. A method for establishing access to a body lumen in a patient, said method comprising:

implanting a distal access cannula between the body lumen and a subcutaneous junction location;

implanting a proximal access cannula between the subcutaneous junction location and a catheter connection location;

adjusting the length of at least one of the distal access cannula and the proximal access cannula; and

connecting a proximal end of the distal access cannula to a distal end of the proximal access cannula at the subcutaneous junction location.

2. A method as in claim 1, wherein the adjusting step comprises adjusting the length of both the distal access cannula and the proximal access.

3. A method as in claim 1, wherein the adjusting step comprises cutting the end of the distal access cannula adjacent to the subcutaneous junction location.

4. A method as in claim 3, wherein the distal access cannula is cut after the distal access cannula has been implanted.

5. A method as in claim 3, wherein the distal access cannula is cut prior to the implanting step.

6. A method as in claim 1, wherein the subcutaneous junction location is immediately adjacent to the body lumen.

7. A method as in claim 6, wherein the subcutaneous junction location is from 0 cm to 5 cm from the body lumen.

8. A method as in claim 1, wherein the subcutaneous junction location is from 5 cm to 50 cm from the body lumen.

9. A method as in claim 1, wherein the distal access cannula implanting step comprises introducing a distal end of said cannula through a body membrane into the body lumen.

10. A method as in claim 9, wherein the body lumen is a blood vessel and the distal end of the distal access cannula is connected through an incision or needle-penetration in the blood vessel wall.

11. A method as in claim 10, wherein the distal end of the cannula comprises a cross-tube which is implanted through the incision.

12. A method as in claim 10, wherein at least 1 cm of the distal end of the cannula is implanted to lie within the blood vessel lumen in an in-dwelling manner.

13. A method as in claim 9, wherein the distal end of the cannula is connected to the blood vessel wall by an end-to-side anastomosis.

14. A method as in claim 1, wherein the proximal access cannula implanting step comprises passing a proximal end of said cannula transcutaneously to provide external access to said proximal end.

15. A method as in claim 14, wherein the proximal end of the proximal access cannula comprises a connector adapted for removable connection to an external catheter.

16. A method as in claim 1, wherein the proximal access cannula implanting step comprises subcutaneously implanting a port which is connected to a proximal end of said cannula.

17. A method as in claim 1, wherein the distal access cannula and the proximal access cannula have substantially equal lumenal diameters.

18. A method as in claim 17, wherein the lumenal diameters are in the range from 1 mm to 10 mm.

19. A method as in claim 1, wherein the distal access cannula has at least a distal lumenal diameter which is less than a lumenal diameter of the proximal access cannula.

20. A method as in claim 19, wherein distal lumenal diameter of the distal access cannula is in the range from 1 mm to 6 mm and the lumenal diameter of the proximal access cannula is in the range from 3 mm to 10 mm.

21. A method as in claim 1, wherein lumenal diameter of the distal access cannula is substantially uniform over its entire length.

22. A method as in claim 1, wherein the lumenal diameter of the distal access cannula is larger over its proximal region than over its distal region.

23. A method as in claim 1, wherein the connecting step comprises providing a connector having a first attachment aperture and a second attachment aperture and a lumen therebetween, attaching the proximal end of the distal access cannula to the first attachment aperture, and attaching the distal end of the proximal access cannula to the second attachment aperture.

24. A method as in claim 23, wherein the first and second attachment apertures are disposed at a relative angle in the range from 45°

to 270°

.

25. A method as in claim 24, wherein the relative angle is in the range from 90°

to 180°

.

26. A method as in claim 24, wherein the connector comprises an angled tube having a spanning web to inhibit tissue in-growth.

27. A method as in claim 23, wherein the first and second attachment apertures are coaxially aligned.

28. An improved method for establishing access between a body lumen having a subcutaneous penetration in a lumenal wall and an implanted port, said method being of the type wherein a cannula having a first end, a second end, and subcutaneously attached at the first end to the penetration in the lumenal wall of the body lumen and attached at the second end to the port, wherein the improvement comprises implanting a cannula wherein the cannula lumen is larger in a region at the second end connected to the port than at the first end connected to the body lumen penetration, wherein the cannula lumen diameter in the first end connected to the body lumen wall penetration is in the range from 1 mm to 6 mm and the cannula lumen diameter in the second end connected to the port is in the range from 3 mm to 10 mm.

29. A method for establishing access to a body lumen in a patient, said method comprising:

providing an access cannula having a small diameter distal region and a large diameter proximal region; and

implanting the access catheter so that the small diameter distal region is connected to the body lumen with a distal end of the large diameter proximal region located subcutaneously, wherein a proximal end of the proximal region is available for connection to a catheter, wherein the distal region lumenal diameter is in the range from 1 mm to 6 mm and the proximal lumenal diameter is in the range 3 mm to 10 mm.

30. A method as in claim 29, wherein lumenal diameter of the distal region of the access cannula is substantially uniform over its entire length.

31. A method as in claim 30, wherein the lumenal diameter of the proximal region of the access cannula is substantially uniform over its entire length.

32. A method as in claim 29, wherein the access cannula implanting step comprises introducing a distal end of said cannula through a body membrane into the body lumen.

33. A method as in claim 32, wherein the body lumen is a blood vessel and the distal end of the distal access cannula is connected to an incision or needle-penetration in the blood vessel wall.

34. A method as in claim 33, wherein the distal end of the cannula comprises a cross-tube which is implanted through the incision.

35. A method as in claim 33, wherein at least 1 cm of the distal end of the cannula is implanted to lie within the blood vessel lumen in an in-dwelling manner.

36. A method as in claim 29, wherein the distal end of the access cannula is connected to the blood vessel wall by an end-to-side anastomosis.

37. A method as in claim 29, wherein the access cannula implanting step comprises passing a proximal end of said cannula transcutaneously to provide external access to said proximal end.

38. A method as in claim 37, wherein the proximal end of the proximal access cannula comprises a connector adapted for removable connection to the an external catheter.

39. A method as in claim 29, wherein the access cannula implanting step comprises subcutaneously implanting a port which is connected to a proximal end of said cannula.

40. A method as in claim 29, wherein the access cannula comprises a distal portion and a proximal portion and wherein the implanting step comprises connecting a proximal end of the distal portion to a distal end of the proximal portion at a subcutaneous junction location.

41. A method as in claim 40, wherein the distal portion and the distal region are coextensive and wherein the proximal portion and the proximal region are coextensive.

42. A method as in claim 40, wherein the distal portion comprises both the distal region and a port of the proximal region.

43. A method as in claim 40, wherein the subcutaneous junction location is immediately adjacent to the body lumen.

44. A method as in claim 43, wherein the subcutaneous junction location is from 0 cm to 5 cm from the body lumen.

45. A method as in claim 40, wherein the subcutaneous junction location is from 5 cm to 50 cm from the body lumen.

46. A method as in claim 40, wherein the connecting step comprises providing a connector having a first attachment aperture and a second attachment aperture and a lumen therebetween, attaching the proximal end of the distal portion of the access cannula to the first attachment aperture, and attaching the distal end of the proximal portion of the access cannula to the second attachment aperture.

47. A method as in claim 46, wherein the first and second attachment apertures are disposed at a relative angle in the range from 45°

to 270°

.

48. A method as in claim 47, wherein the relative angle is in the range from 90°

to 180°

.

49. A method as in claim 47, wherein the connector comprises an angled tube having spanning a web to inhibit tissue in-growth.

50. A method as in claim 46, wherein the first and second attachment apertures are coaxially aligned.

51. A method as in claim 40, further comprising adjusting the length of at least one of the distal portion and the proximal portion of the access catheter prior to the connecting step.

52. A method as in claim 51, wherein the adjusting step comprises adjusting the length of both the distal access cannula and the proximal access cannula.

53. A method as in claim 52, wherein the adjusting step comprises cutting the end of the cannula adjacent to the subcutaneous junction location.

54. A method as in claim 53, wherein the cannula is cut after the cannula has been implanted.

55. A method as in claim 53, wherein the cannula is cut prior to the implanting step.

56. A method for establishing access to a body lumen in a patient, said method comprising:

providing an access cannula having a small diameter distal region and a large diameter proximal region; and

implanting the access catheter so that the small diameter distal region is connected through a wall of the body lumen which comprises a blood vessel lumen with a distal end of the large diameter proximal region located subcutaneously, wherein a proximal end of the proximal region is available for connection to a catheter, wherein at least 1 cm of the distal end of the cannula is implanted to lie within the blood vessel lumen in an in-dwelling manner.

57. A method as in claim 56, wherein distal region lumenal diameter is in the range from 1 mm to 6 mm and the proximal lumenal diameter is in the range 3 mm to 10 mm.

58. A method as in claim 57, wherein lumenal diameter of the distal region of the access cannula is substantially uniform over its entire length.

59. A method as in claim 58, wherein the lumenal diameter of the proximal region of the access cannula is substantially uniform over its entire length.

60. A method as in claim 56, wherein the access cannula implanting step comprises introducing a distal end of said cannula through a blood vessel wall into the blood vessel lumen.

61. A method as in claim 60, wherein the distal end of the distal access cannula is connected to an incision or needle-penetration in the blood vessel wall.

62. A method as in claim 61, wherein the distal end of the cannula comprises a cross-tube which is implanted through the incision.

63. A method as in claim 56, wherein the distal end of the access cannula is connected to the blood vessel wall by an end-to-side anastomosis.

64. A method as in claim 56, wherein the access cannula implanting step comprises passing a proximal end of said cannula transcutaneously to provide external access to said proximal end.

65. A method as in claim 64, wherein the proximal end of the proximal access cannula comprises a connector adapted for removable connection to the an external catheter.

66. A method as in claim 56, wherein the access cannula implanting step comprises subcutaneously implanting a port which is connected to a proximal end of said cannula.

67. A method as in claim 56, wherein the access cannula comprises a distal portion and a proximal portion and wherein the implanting step comprises connecting a proximal end of the distal portion to a distal end of the proximal portion at a subcutaneous junction location.

68. A method as in claim 67, wherein the distal portion and the distal region are coextensive and wherein the proximal portion and the proximal region are coextensive.

69. A method as in claim 67, wherein the distal portion comprises both the distal region and a port of the proximal region.

70. A method as in claim 67, wherein the subcutaneous junction location is immediately adjacent to the body lumen.

71. A method as in claim 70, wherein the subcutaneous junction location is from 0 cm to 5 cm from the body lumen.

72. A method as in claim 67, wherein the subcutaneous junction location is from 5 cm to 50 cm from the body lumen.

73. A method as in claim 67, wherein the connecting step comprises providing a connector having a first attachment aperture and a second attachment aperture and a lumen therebetween, attaching the proximal end of the distal portion of the access cannula to the first attachment aperture, and attaching the distal end of the proximal portion of the access cannula to the second attachment aperture.

74. A method as in claim 73, wherein the first and second attachment apertures are disposed at a relative angle in the range from 45°

to 270°

.

75. A method as in claim 74, wherein the relative angle is in the range from 90°

to 180°

.

76. A method as in claim 74, wherein the connector comprises an angled tube having a spanning web to inhibit tissue in-growth.

77. A method as in claim 73, wherein the first and second attachment apertures are coaxially aligned.

78. A method as in claim 58, further comprising adjusting the length of at least one of the distal portion and the proximal portion of the access catheter prior to the connecting step.

79. A method as in claim 78, wherein the adjusting step comprises adjusting the length of both the distal access cannula and the proximal access cannula.

80. A method as in claim 79, wherein the adjusting step comprises cutting the end of the cannula adjacent to the subcutaneous junction location.

81. A method as in claim 80, wherein the cannula is cut after the cannula has been implanted.

82. A method as in claim 80, wherein the cannula is cut prior to the implanting step.

83. A method for establishing access to a body lumen in a patient, said method comprising:

providing an access cannula having a small diameter distal region and a large diameter proximal region; and

implanting the access catheter so that the small diameter distal region is connected to the body lumen with a distal end of the large diameter proximal region located subcutaneously, wherein a proximal end of the proximal region is available for connection to a catheter, wherein the distal end of the access cannula is connected to a blood vessel wall by an end-to-side anastomosis.

84. A method as in claim 83, wherein distal region lumenal diameter is in the range from 1 mm to 6 mm and the proximal lumenal diameter is in the range 3 mm to 10 mm.

85. A method as in claim 84, wherein lumenal diameter of the distal region of the access cannula is substantially uniform over its entire length.

86. A method as in claim 85, wherein the lumenal diameter of the proximal region of the access cannula is substantially uniform over its entire length.

87. A method as in claim 83, wherein the access cannula implanting step comprises passing a proximal end of said cannula transcutaneously to provide external access to said proximal end.

88. A method as in claim 87, wherein the proximal end of the proximal access cannula comprises a connector adapted for removable connection to the an external catheter.

89. A method as in claim 83, wherein the access cannula implanting step comprises subcutaneously implanting a port which is connected to a proximal end of said cannula.

90. A method as in claim 83, wherein the access cannula comprises a distal portion and a proximal portion and wherein the implanting step comprises connecting a proximal end of the distal portion to a distal end of the proximal portion at a subcutaneous junction location.

91. A method as in claim 90, wherein the distal portion and the distal region are coextensive and wherein the proximal portion and the proximal region are coextensive.

92. A method as in claim 90, wherein the distal portion comprises both the distal region and a port of the proximal region.

94. A method as in claim 90, wherein the subcutaneous junction location is from 0 cm to 5 cm from the body lumen.

95. A method as in claim 90, wherein the subcutaneous junction location is from 5 cm to 50 cm from the body lumen.

96. A method as in claim 90, wherein the connecting step comprises providing a connector having a first attachment aperture and a second attachment aperture and a lumen therebetween, attaching the proximal end of the distal portion of the access cannula to the first attachment aperture, and attaching the distal end of the proximal portion of the access cannula to the second attachment aperture.

97. A method as in claim 96, wherein the first and second attachment apertures are disposed at a relative angle in the range from 45°

to 270°

.

98. A method as in claim 97, wherein the relative angle is in the range from 90°

to 180°

.

99. A method as in claim 97, wherein the connector comprises an angled tube having a spanning web to inhibit tissue in-growth.

100. A method as in claim 96, wherein the first and second attachment apertures are coaxially aligned.

101. A method as in claim 90, further comprising adjusting the length of at least one of the distal portion and the proximal portion of the access catheter prior to the connecting step.

102. A method as in claim 101, wherein the adjusting step comprises adjusting the length of both the distal access cannula and the proximal access cannula.

103. A method as in claim 102, wherein the adjusting step comprises cutting the end of the cannula adjacent to the subcutaneous junction location.

104. A method as in claim 103, wherein the cannula is cut after the cannula has been implanted.

105. A method as in claim 103, wherein the cannula is cut prior to the implanting step.

93. A method as in claim 93, wherein the subcutaneous junction location is immediately adjacent to the body lumen.

106. A method for establishing access to a body lumen in a patient, said method comprising:

providing an access cannula having a small diameter distal region and a large diameter proximal region; and

implanting the access catheter so that the small diameter distal region is connected to the body lumen with a distal end of the large diameter proximal region located subcutaneously, wherein a proximal end of the proximal region is available for connection to a catheter, wherein the access cannula implanting step comprises passing a proximal end of said cannula transcutaneously to provide external access to said proximal end.

107. A method as in claim 106, wherein distal region lumenal diameter is in the range from 1 mm to 6 mm and the proximal lumenal diameter is in the range 3 mm to 10 mm.

108. A method as in claim 107, wherein lumenal diameter of the distal region of the access cannula is substantially uniform over its entire length.

109. A method as in claim 108, wherein the lumenal diameter of the proximal region of the access cannula is substantially uniform over its entire length.

110. A method as in claim 106, wherein the access cannula implanting step comprises introducing a distal end of said cannula through a body membrane into the body lumen.

111. A method as in claim 110, wherein the body lumen is a blood vessel and the distal end of the distal access cannula is connected to an incision or needle-penetration in the blood vessel wall.

112. A method as in claim 111, wherein the distal end of the cannula comprises a cross-tube which is implanted through the incision.

113. A method as in claim 111, wherein at least 1 cm of the distal end of the cannula is implanted to be within the blood vessel lumen in an in-dwelling manner.

114. A method as in claim 106, wherein the distal end of the access cannula is connected to the blood vessel wall by an end-to-side anastomosis.

115. A method as in claim 106, wherein the proximal end of the proximal access cannula comprises a connector adapted for removable connection to the an external catheter.

116. A method as in claim 106, wherein the access cannula comprises a distal portion and a proximal portion and wherein the implanting step comprises connecting a proximal end of the distal portion to a distal end of the proximal portion at a subcutaneous junction location.

117. A method as in claim 116, wherein the distal portion and the distal region are coextensive and wherein the proximal portion and the proximal region are coextensive.

118. A method as in claim 116, wherein the distal portion comprises both the distal region and a port of the proximal region.

119. A method as in claim 116, wherein the subcutaneous junction location is immediately adjacent to the body lumen.

120. A method as in claim 119, wherein the subcutaneous junction location is from 0 cm to 5 cm from the body lumen.

121. A method as in claim 116, wherein the subcutaneous junction location is from 5 cm to 50 cm from the body lumen.

122. A method as in claim 116, wherein the connecting step comprises providing a connector having a first attachment aperture and a second attachment aperture and a lumen therebetween, attaching the proximal end of the distal portion of the access cannula to the first attachment aperture, and attaching the distal end of the proximal portion of the access cannula to the second attachment aperture.

123. A method as in claim 122, wherein the first and second attachment apertures are disposed at a relative angle in the range from 45°

to 270°

.

124. A method as in claim 123, wherein the relative angle is in the range from 90°

to 180°

.

125. A method as in claim 123, wherein the connector comprises an angled tube having a spanning web to inhibit tissue in-growth.

126. A method as in claim 122, wherein the first and second attachment apertures are coaxially aligned.

127. A method as in claim 116, further comprising adjusting the length of at least one of the distal portion and the proximal portion of the access catheter prior to the connecting step.

128. A method as in claim 127, wherein the adjusting step comprises adjusting the length of both the distal access cannula and the proximal access cannula.

129. A method as in claim 128, wherein the adjusting step comprises cutting the end of the cannula adjacent to the subcutaneous junction location.

130. A method as in claim 129, wherein the cannula is cut after the cannula has been implanted.

131. A method as in claim 129, wherein the cannula is cut prior to the implanting step.