Valve port and method for vascular access

• US 6,007,516 A
• Filed: 10/02/1997
• Issued: 12/28/1999
• 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., Kuiper, Hendrik E., Finch, C. David
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US08/942,990
• Time in Patent Office: 817 Days
• Field of Search: 604/4, 604/49, 604/53, 604/93, 604/167, 604/175, 604/264, 604/246, 604/245, 604/249, 604/250, 604/256, 604/891.1, 251/149.6, 251/149.7, 251/7
• US Class Current: 604/288.03
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2039/009 Means for limiting access to the septum, e.g. shields, grids
• 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

Abstract

An access port comprises a base and a flexible conduit. The port is subcutaneously implanted and the conduit is attached directly or indirectly to a blood vessel or other body lumen or cavity. An actuator mechanism is provided with a linkage which opens a valve in the port in response to percutaneous insertion of a needle into the access port. In particular, insertion of the needle opens the clamping mechanism to permit flow through the conduit between the blood vessel and the needle.

Claims

1. A method for percutaneously accessing a body lumen, said method comprising:

maintaining a conduit between an implanted access port and the body lumen, said conduit being externally clamped; and

percutaneously inserting an access tube into the access port, wherein the inserting step relieves the external clamping to permit fluid flow through the conduit.

2. A method as in claim 1, wherein the flow through the conduit is blood flow from the body lumen to the access port and access tube.

3. A method as in claim 2, wherein blood is withdrawn from the access port at a rate of at least 250 ml/min.

4. A method as in claim 3, wherein the blood flow rate is at least 300 ml/min.

5. A method as in claim 4, wherein the blood flow rate is at least 400 ml/min.

6. A method as in claim 5, wherein the blood flow rate is at least 500 ml/min.

7. A method as in claim 1, wherein the flow through the conduit is fluid flow from the access tube through the access port to the body lumen.

8. A method as in claim 7, wherein the fluid flow to the body lumen comprises blood flow.

9. A method as in claim 7, wherein the fluid flow to the body lumen comprises a drug.

10. A method as in claim 1, further comprising passing the blood through an external blood treatment circuit and returning the treated blood or a portion thereof to the patient.

11. A method as in claim 10, wherein the external blood treatment circuit comprises a hemodialysis circuit, a hemofiltration unit, or an apheresis circuit.

12. A method as in claim 1, wherein a proximal end of the conduit is disposed within the access port and a distal end of the conduit is attached to the body lumen.

13. A method as in claim 12, wherein the conduit comprises a single, continuous tube.

14. A method as in claim 12, wherein the conduit comprises at least two distinct axial portions.

15. A method as in claim 1, wherein a proximal end of the conduit is disposed within the access port and a distal end of the conduit terminates in a connector for attachment to a separate catheter.

16. A method as in claim 1, wherein a flexible portion of the conduit is clamped by a spring-loaded clamp mechanism and wherein insertion of the access tube actuates a linkage which overcomes the spring force to open the clamp mechanism.

17. A method as in claim 1, wherein the access tube is inserted in a direction generally normal to a patient'"'"'s skin and wherein the conduit extends from the access port to the body lumen in a plane generally parallel to the patient'"'"'s skin.

18. A method for percutaneously accessing a body lumen, said method comprising:

maintaining a conduit between an implanted access port and the body lumen; and

percutaneously inserting an access tube into the access port, wherein the access tube engages a linkage which opens a valve structure in the conduit which is located remotely from the portion of the access port into which the access tube has been inserted.

19. A method as in claim 18, wherein the flow through the conduit is blood flow from the body lumen to the access port and access tube.

20. A method as in claim 19, wherein blood is withdrawn from the access port at a rate of at least 250 ml/min.

21. A method as in claim 20, wherein the blood flow rate is at least 300 ml/min.

22. A method as in claim 21, wherein the blood flow rate is at least 400 ml/min.

23. A method as in claim 22, wherein the blood flow rate is at least 500 ml/min.

24. A method as in claim 18, wherein the flow through the conduit is fluid flow from the access tube through the access port to the body lumen.

25. A method as in claim 24, wherein the fluid flow to the body lumen comprises blood flow.

26. A method as in claim 24, wherein the fluid flow to the body lumen comprises a drug.

27. A method as in claim 18, wherein the valve structure comprises a spring-loaded clamp which constricts a flexible portion of the conduit when the linkage is not engaged by the access tube.

28. A method as in claim 18, wherein a proximal end of the conduit is disposed within the implantable port and a distal end of the conduit is attached to the body lumen.

29. A method as in claim 18, wherein the valve structure comprises a slide valve.

30. A method as in claim 18, wherein a reciprocatory block of the valve structure comprises the linkage which is actuated by the access tube, wherein actuation causes the block to move to align portions of the passage.

31. A method as in claim 30, wherein a proximal end of the conduit is disposed within the access port and a distal end of the conduit terminates in a connector for attachment to a separate catheter.

32. A method as in claim 18, further comprising passing the blood through an external blood treatment circuit and returning the treated blood or a portion thereof to the patient.

33. A method as in claim 18, wherein the external blood treatment circuit comprises a hemodialysis circuit, a hemofiltration unit, or an apheresis circuit.

34. A method for percutaneously accessing a body lumen, said method comprising:

maintaining a conduit between an implanted access port and the body lumen; and

percutaneously inserting an access tube into a tapered bore in a tube seat in the port to establish a generally fluid tight seal therewith;

wherein insertion of the access tube actuates a linkage to open a valve disposed distally of the tube seat to permit flow to the conduit.

35. A method as in claim 34, wherein the flow through the conduit is blood flow from the body lumen to the access port and access tube.

36. A method as in claim 35, wherein blood is withdrawn from the access port at a rate of at least 250 ml/min.

37. A method as in claim 36, wherein the blood flow rate is at least 300 ml/min.

38. A method as in claim 37, wherein the blood flow rate is at least 400 ml/min.

39. A method as in claim 38, wherein the blood flow rate is at least 500 ml/min.

40. A method as in claim 34, wherein insertion of the access tube into the tube seat depresses the tube seat relative to the base which in turn actuates the linkage.

41. A method as in claim 40, wherein the tube seat is locked in the depressed condition until the access tube is removed.

42. A method as in claim 34, wherein a proximal end of the conduit is disposed within the access port and a distal end of the conduit is attached to the body lumen.

43. A method as in claim 42, wherein conduit comprises a single, continuous tube.

44. A method as in claim 42, wherein the conduit comprises at least two distinct axial portions.

45. A method as in claim 34, wherein the flow through the conduit is fluid flow from the access tube through the access port to the body lumen.

46. A method as in claim 45, wherein the fluid flow to the body lumen comprises blood flow.

47. A method as in claim 45, wherein the fluid flow to the body lumen comprises a drug.

48. A method as in claim 34, wherein the tube seat comprises a tapered bore which frictionally engages the outside of the access tube as the tube is inserted into the bore.

49. A method as in claim 34, wherein a proximal end of the conduit is disposed within the access port and a distal end of the conduit terminates in a connector for attachment to a separate catheter.

50. A method as in claim 34, further comprising passing the blood through an external blood treatment circuit and returning the treated blood or a portion thereof to the patient.

51. A method as in claim 34, wherein the external blood treatment circuit comprises a hemodialysis circuit, a hemofiltration unit, or an apheresis circuit.

52. A method for percutaneously accessing a body lumen, said method comprising:

maintaining a conduit between an implanted access port and the body lumen; and

percutaneously inserting a rigid access tube into a cylindrical passage in the access port in a vertical orientation, wherein the passage is connected to the conduit through an elbow of from 75°

to 105°

.

53. A method as in claim 52, wherein the flow through the conduit is blood flow from the body lumen to the access port and access tube.

54. A method as in claim 53, wherein blood is withdrawn from the access port at a rate of at least 250 ml/min.

55. A method as in claim 54, wherein the blood flow rate is at least 300 ml/min.

56. A method as in claim 55, wherein the blood flow rate is at least 400 ml/min.

57. A method as in claim 56, wherein the blood flow rate is at least 500 ml/min.

58. A method as in claim 53, wherein the fluid flow to the body lumen comprises blood flow.

59. A method as in claim 52, wherein the conduit is externally clamped and wherein the inserting step relieves the external clamping to permit fluid flow through the conduit.

60. A method as in claim 59, wherein a flexible portion of the conduit is clamped by a spring-loaded clamp mechanism and wherein insertion of the access tube actuates a linkage which overcomes the spring force to open the clamp mechanism.

61. A method as in claim 60, wherein the access tube is inserted in a direction generally normal to a patient'"'"'s skin and wherein the conduit extends from the access port to the body lumen in a plane generally parallel to the patient'"'"'s skin.

62. A method as in claim 52, wherein a proximal end of the conduit is disposed within the access port and a distal end of the conduit is attached to the body lumen.

63. A method as in claim 62, wherein conduit comprises a single, continuous tube.

64. A method as in claim 62, wherein the conduit comprises a composite structure having at least two distinct axial portions.

65. A method as in claim 52, wherein a proximal end of the conduit is disposed within the access port and a distal end of the conduit terminates in a connector for attachment to a separate catheter.

66. A method as in claim 53, wherein the flow through the conduit is fluid flow from the access tube through the access port to the body lumen.

67. A method as in claim 52, wherein the fluid flow to the body lumen comprises a drug.

68. A method as in claim 52, further comprising passing the blood through an external blood treatment circuit and returning the treated blood or a portion thereof to the patient.

69. A method as in claim 52, wherein the external blood treatment circuit comprises a hemodialysis circuit, a hemofiltration unit, or an apheresis circuit.

70. An implantable port comprising:

a base having a passage with (a) an inlet for receiving an access tube and (b) an outlet;

a linkage actuated by insertion of an access tube into the inlet; and

a valve structure which opens the passage downstream from the inlet in response to actuation of the linkage by an access tube.

71. An implantable port as in claim 70, wherein the valve structure comprises a flexible conduit and a clamp which opens and closes about the conduit in response to actuation of the linkage.

72. An implantable port as in claim 71, wherein the passage comprises a tapered bore which seals against the access tube as said tube is inserted therein.

73. An implantable port as in claim 72, wherein the flexible conduit is attached to a small diameter end of the tapered bore.

74. An implantable port as in claim 73, wherein the flexible conduit is attached to the tapered bore at an angle from 75°

to 105°

.

75. An implantable port as in claim 74, wherein the flexible conduit has a proximal end disposed within the base and a distal end which terminates on a connector on an external surface of the base.

76. An implantable port as in claim 71, wherein the flexible conduit has a proximal end disposed within the base and a distal end disposed outside of the base.

77. An implantable port as in claim 76, wherein the distal end of the conduit is adapted for direct connection to a body lumen.

78. An implantable port as in claim 76, wherein the distal end of the conduit is adapted for connection to one end of a catheter.

79. An implantable port as in claim 76, wherein the distal end of the conduit terminates in a lower connector.

80. An implantable port as in claim 71, wherein the passage and the conduit are joined to form a substantially continuous flow lumen which is free from stagnant regions.

81. An implantable port as in claim 71, wherein the flexible conduit has a proximal end disposed within the base and a distal end which terminates on a connector on an external surface of the base.

82. An implantable port as in claim 71, wherein the linkage assembly is disposed wholly within the base.

83. An implantable port as in claim 71, wherein the linkage is actuated by passage of the access tube into the passage which results in release of a clamp from the exterior of the flexible conduit.

84. An implantable port as in claim 70, wherein the valve structure comprises a slide valve.

85. An implantable port as in claim 84, wherein the slide valve comprises a reciprocating block having the inlet portion of the passage formed therein, wherein the reciprocating block comprises the linkage.

86. An implantable port as in claim 85, wherein insertion of an access tube in the reciprocating block slides the block so that the passage therein becomes aligned with a downstream portion of the passage in the base.

87. An implantable port comprising:

a base having a passage for receiving an access tube;

a flexible conduit disposed to establish fluid flow with an access tube inserted through the passage; and

a clamp disposed externally about the flexible conduit, wherein the clamp opens about the conduit to permit fluid flow therethrough when an access tube is inserted into the passage and closes over the conduit when the access tube is removed from the passage.

88. An implantable port as in claim 87, wherein the passage comprises a tapered bore which seals against the access tube as said tube is inserted therein.

89. An implantable port as in claim 88, wherein the flexible conduit is attached to a small diameter end of the tapered bore.

90. An implantable port as in claim 89, wherein the flexible conduit is attached to the tapered bore at an angle from 75°

to 105°

.

91. An implantable port as in claim 87, further comprising a linkage assembly including an actuator which senses entry of the access tube into the passage in the base and which opens the clamp in response to such passage.

92. An implantable port as in claim 91, wherein the linkage assembly is disposed wholly within the base.

93. An implantable port as in claim 87, wherein the flexible conduit has a proximal end disposed within the base and a distal end disposed outside of the base.

94. An implantable port as in claim 93, wherein the passage and the conduit are joined to form a substantially continuous flow lumen which is free from stagnant regions.

95. An implantable port as in claim 93, wherein the distal end of the conduit is adapted for direct connection to a body lumen.

96. An implantable port as in claim 93, wherein the distal end of the conduit is adapted for connection to one end of a catheter.

97. An implantable port as in claim 93, wherein the distal end of the conduit terminates in a lower connector.

98. An implantable port comprising:

a base having a cylindrical inlet passage for receiving an access tube, and an outlet passage disposed to receive fluid flow from an access tube inserted through the inlet passage;

wherein the inlet passage is oriented along a vertical axis and the outlet passage is disposed along a horizontal axis.

99. An implantable port as in claim 98, wherein the inlet passage and the outlet passage are joined to form a substantially continuous flow lumen which is free from stagnant regions.

100. An implantable port as in claim 99, wherein the outlet passage comprises a flexible catheter and the vertically oriented inlet passage is defined by a rigid tube.

101. An implantable port as in claim 100, wherein the inlet passage comprises a tapered bore which seals against the access tube as said tube is inserted therein.

102. An implantable port as in claim 101, wherein the flexible conduit is attached to a small diameter end of the tapered bore.

103. An implantable port as in claim 102, wherein the flexible conduit is attached to the tapered bore at an angle from 75°

to 105°

.

104. An implantable port as in claim 100, wherein the flexible catheter is joined to the rigid tube at an elbow having an angle from 75°

to 105°

.

105. An implantable port as in claim 98, wherein the outlet passage comprises a proximal end disposed within the base and a distal end disposed outside of the base.

106. An implantable port as in claim 105, wherein the distal end of the flexible conduit of the outlet passage is adapted for direct connection to a body lumen.

107. An implantable port as in claim 105, wherein the distal end of the conduit is adapted for connection to one end of a catheter.

108. An implantable port as in claim 105, wherein the distal end of the conduit terminates in a connector external to the base.

109. An implantable port as in claim 98, further comprising a linkage assembly and a valve, said linkage assembly being actuated by entry of the access tube into the inlet which entry opens the valve.

110. An implantable port as in claim 109, wherein entry of the access tube moves the linkage assembly in the direction of the access tube.

111. An implantable port as in claim 98, wherein the flexible conduit has a proximal end disposed within the base and a distal end which terminates on a connector on an external surface of the base.

112. An implantable port comprising:

a base having a first passage for receiving an access tube;

a flexible conduit disposed through a second passage in the base;

an actuator assembly reciprocatably received in the base having a bore aligned with the first passage for receiving the access tube, wherein a proximal end of the flexible conduit is mechanically coupled to the bore in the actuator assembly; and

a spring for urging the actuator assembly to a first position in the base wherein the relative position of the actuator assembly and the second passage closes the flexible conduit and wherein insertion of the access tube into the first passage shifts the actuator assembly to a second position which opens the flexible conduit.

113. An implantable port as in claim 112, wherein the bore comprises a tapered bore which seals against an access tube as said tube is inserted therein.

114. An implantable port as in claim 113, wherein the flexible conduit is attached to a small diameter end of the tapered bore.

115. An implantable port as in claim 114, wherein the flexible conduit is attached to the tapered bore at an angle from 75°

to 105°

.

116. An implantable port as in claim 112, wherein the actuator assembly comprises a lower lip and the second passage in the base comprises an upper lip, wherein the upper an lower lips are opposed on opposite sides or the flexible conduit so that the spring closes said lips together to close the lumen within the conduit.

117. An implantable port as in claim 112, wherein the flexible conduit has a proximal end disposed within the base and a distal end disposed outside of the base.

118. An implantable port as in claim 112, wherein the distal end is adapted for direct connection to a body lumen.

119. An implantable port as in claim 112, wherein the distal end of the conduit is adapted for connection to one end of a catheter.

120. An implantable port as in claim 112, wherein the distal end of the conduit teminates in a lower connector.

121. An implantable port as in claim 112, wherein the flexible conduit has proximal end disposed within the base and a distal end which terminates on a connector on an external surface of the base.

122. An implantable port as in claim 112, wherein the actuator assembly and spring are disposed wholly within the base.

123. An implantable port comprising:

a base having a passage for receiving an access tube;

a valve assembly in the base, said valve assembly having a bore which is aligned with the passage and receives the access tube;

a pair of balls disposed between the passage in the base and the bore in the valve, wherein the balls are spring-biased to close against and lock the access tube when the access tube is inserted through the passage and port.

124. An implantable port as in claim 123, wherein the valve comprises an assembly that is reciprocatably mounted within the base and a spring which urges the assembly toward the passage in the base, wherein the balls are disposed over the assembly and move radially outwardly into an expanded region of the passage as they move downward in response to insertion of the access tube.