Hemodialysis system and method

• US 20030014003A1
• Filed: 06/20/2002
• Published: 01/16/2003
• Est. Priority Date: 06/20/2001
• Status: Active Grant

• Current Assignee: Michael Gertner
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Gertner, Michael
• Granted Patent: US 7,144,381 B2
• Time in Patent Office: Days
• US Class Current: 604/5.01
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3673 Anticoagulant coating, e.g. Heparin coating

Abstract

A treatment assembly is positioned along an AV-fistula and couples therapeutic energy to an adjacent area due to a material response to an applied energy field from a remotely located energy source. The treatment assembly may be delivered into the fistula through a hemodialysis needle, or may be secured to the fistula graft itself and implanted therewith within a patient. A cover provides a shield between an anastomosis area and blood flow. Another AV-fistula includes a valved reservoir that receives a fluid agent from a hemodialysis needle while moving the needle into or from the fistula; the agent leaks from the reservoir into the fistula lumen. Another valved fistula is adjustable between an open condition and closed conditions during and between hemodialysis treatments, respectively. Another AV-fistula has a bladder reservoir coupled to a second refillable fluid reservoir and is adapted to locally deliver a therapeutic agent into the fistula lumen.

Claims

1. A hemodialysis system, comprising:

at least one treatment assembly that is adapted to be positioned at a location along an AV-fistula graft when the AV-fistula is implanted within the patient and extending between first and second anastomoses to a vein and an artery, respectively;

wherein the treatment assembly is adapted to couple energy between the treatment assembly and an area adjacent to the treatment assembly at the location; and

wherein the coupled energy is sufficient to provide a therapeutic affect at least in the area.

2. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to be positioned at the location along one of two opposite end portions of the AV-fistula graft that is adapted to be anastomosed to the artery or vein.

3. The hemodialysis system of claim 2, wherein the treatment assembly is adapted to be positioned at the location along the end portion that is adapted to be anastomosed to the vein.

4. The hemodialysis system of claim 3, wherein the treatment assembly is adapted to be positioned at either of two locations along each of the two opposite end portions, respectively, that are adapted to be anastomosed to the vein and artery, also respectively.

5. The hemodialysis system of claim 1, further comprising two said treatment assemblies that are adapted to be positioned at locations along each of two opposite end portions of the AV-fistula graft, respectively, that are adapted to be anastomosed to the vein and artery, also respectively.

6. The hemodialysis system of claim 1, further comprising:

a delivery member with an elongate body having a proximal end portion and a distal end portion;

wherein the treatment assembly is located along the distal end portion of the elongate body; and

wherein the delivery member is adapted to deliver the treatment assembly along the distal end portion to the location.

7. The hemodialysis system of claim 6, wherein the distal end portion and treatment assembly are adapted to be delivered to the location through a hemodialysis needle and into the AV-fistula graft extending between the vein and artery anastomoses.

8. The hemodialysis system of claim 6, wherein at least the distal end portion of the delivery member is adapted to track over a guide wire to the location within the AV-fistula graft.

9. The hemodialysis system of claim 8, further comprising:

a guidewire with an elongate body having a proximal end portion and a distal end portion;

wherein the distal end portion of the guidewire is adapted to have a shaped tip;

wherein the guidewire is substantially torquable such that the tip is steerable in-vivo by manipulating the proximal end portion externally from the patient'"'"'s body; and

wherein the delivery member is adapted to slidably engage and track over the guidewire to the location.

10. The hemodialysis system of claim 6, wherein:

the delivery member further comprises a deflection member extending from the proximal end portion of the delivery member and the distal end portion; and

wherein the distal end portion has a deflectable shape by manipulating the deflection member along the proximal end portion of the elongate body of the delivery member.

11. The hemodialysis system of claim 6, wherein the treatment assembly further comprises:

an expandable member that is expandable between a radially collapsed condition and a radially expandable condition;

wherein in the radially collapsed condition the expandable member has a first outer diameter that is adapted to be delivered to the location within a lumen of an AV-fistula graft through a hemodialysis needle;

wherein in the radially expanded condition the expandable member has a second outer diameter larger than the first outer diameter;

and wherein the treatment assembly is adapted to couple energy to the area adjacent the expandable member in the radially expanded condition.

12. The hemodialysis system of claim 11, wherein the treatment assembly is adapted to couple energy to a circumferential area surrounding the expandable member in the radially expanded condition.

13. The hemodialysis system of claim 12, wherein the expandable member comprises an inflatable balloon.

14. The hemodialysis system of claim 13, wherein the inflatable balloon comprises a substantially elastomeric material.

15. The hemodialysis system of claim 14, wherein the material is chosen from the group consisting of polyurethane, silicone, latex rubber, or combinations or blends thereof.

16. The hemodialysis system of claim 13, wherein the material comprises a relatively non-compliant material such that the balloon is folded in the radially collapsed condition.

17. The hemodialysis system of claim 13, wherein the inflatable balloon comprises a balloon wall and a material associated with the balloon wall that is responsive to an applied energy field to couple the energy to the area.

18. The hemodialysis system of claim 13, further comprising an inflation medium within the inflatable balloon that is responsive to an applied energy field to couple the energy to the area.

19. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to be implanted at the location along the AV-fistula graft.

20. The hemodialysis system of claim 19, further comprising:

an AV-fistula graft with a tubular graft body;

wherein the treatment assembly is permanently secured to the graft body at the location.

21. The hemodialysis system of claim 20, wherein:

the tubular graft body comprises first and second opposite end portions; and

the treatment assembly comprises at least one member that extends beyond one of the two opposite end portions of the tubular graft body.

22. The hemodialysis system of claim 21, wherein the member comprises a tubular member secured to the tubular graft body and extending beyond the end portion.

23. The hemodialysis system of claim 21, wherein:

the at least one member comprises a plurality of adjacent elongate members positioned around a circumference; and

the at least one member extends longitudinally beyond the tubular graft body end.

24. The hemodialysis system of claim 23, wherein the elongate members are adapted to be positioned to cover an anastomosis between the tubular graft body end and a respective artery or vein with respect to blood flow.

25. The hemodialysis system of claim 24, wherein the elongate members are substantially pliable and deflectable under pressure of blood flow in order to cover the anastomosis region.

26. The hemodialysis system of claim 24, wherein the elongate members are positioned along only a portion of the circumference.

27. The hemodialysis system of claim 26, wherein the portion is positioned at a location that is adapted to be on a downstream side of an anastomosis between the graft and a corresponding blood vessel.

28. The hemodialysis system of claim 20, wherein the tubular graft body has a curved shape.

29. The hemodialysis system of claim 1, wherein the treatment assembly comprises a material that is adapted to exhibit a material response to an applied energy field from a remotely located energy source such that the treatment assembly is activated to couple the energy to the area.

30. The AV-fistula graft of claim 29, wherein:

the material is adapted to heat in response to energy received from the remotely located energy source; and

the treatment assembly is adapted to thermally couple energy to the area as a result of the heat response of the material.

31. The AV-fistula graft of claim 29, wherein the material is adapted to exhibit the material response to an applied ultrasonic energy field from a remote ultrasound energy source.

32. The AV-fistula graft of claim 29, wherein the material comprises a ferromagnetic material and is adapted to exhibit the material response to an applied magnetic field from a remotely located inductive energy source.

33. The AV-fistula graft of claim 29, wherein the material is adapted to exhibit the material response to applied light energy from a remotely located light energy source.

34. The AV-fistula graft of claim 33, wherein the material is adapted to exhibit the material response to applied ultraviolet light energy from a remotely located ultraviolet light energy source.

35. The AV-fistula graft of claim 33, wherein the material is adapted to exhibit the material response to applied infrared light energy from a remotely located infrared light energy source.

36. The AV-fistula graft of claim 29, wherein the material is adapted to exhibit the material response to an applied electrical current field from a remotely located electrical current source.

37. The AV-fistula graft of claim 29, wherein the treatment assembly is adapted to be actuated by an applied energy field applied across a skin layer of the patient from a remote energy source located externally of the patient when the treatment assembly is positioned at the location along the AV-graft fistula extending between vein and artery anastomoses within the patient'"'"'s body.

38. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to couple a sufficient amount of energy between the treatment assembly and the area to substantially inhibit formation of a stenosis associated with an AV-fistula implant along the location.

39. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to couple a sufficient amount of energy between the treatment assembly and the area to substantially remove at least a portion of a stenosis associated with the AV-fistula implant.

40. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to couple sufficient energy between the treatment assembly and the area to substantially prevent neo-intimal hyperplasia in the area.

41. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to couple sufficient energy between the treatment assembly and the area to substantially prevent thrombogenesis or thrombus adhesion in the area.

42. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to be delivered into an AV-fistula implant and positioned at the location through a hemodialysis needle.

43. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to couple the energy between the treatment assembly and a substantially circumferential area adjacent to the treatment assembly.

44. The hemodialysis system of claim 43, wherein the substantially circumferential area is adapted to coincide with a circumferential region of an AV-fistula circumscribing an internal lumen of the AV-fistula.

45. The hemodialysis system of claim 1, wherein:

the treatment assembly comprises an adjustable member that is adjustable between a first shape and a second shape;

the first shape has a first outer diameter that is adapted to be delivered into the AV-fistula; and

the second shape has a second outer diameter that is greater than the first outer diameter.

46. The hemodialysis system of claim 45, wherein the second outer diameter is sufficient to couple the energy between the adjustable member and a substantially circumferential area that coincides with a circumferential region of an AV-fistula wall.

47. The hemodialysis system of claim 45, wherein the adjustable member comprises a radially expandable member that is adjustable between a radially collapsed condition that characterizes the first shape and a radially expanded condition that characterizes the second shape.

48. The hemodialysis system of claim 47, wherein the radially expandable member comprises a radially expandable tubular member.

49. The hemodialysis system of claim 48, wherein the radially expandable tubular member comprises an inflatable balloon.

50. The hemodialysis system of claim 49, wherein the inflatable balloon comprises a substantially compliant material.

51. The hemodialysis system of claim 50, wherein the substantially compliant material exhibits at least 500% elongation between the radially collapsed and expanded conditions.

52. The hemodialysis system of claim 50, wherein the substantially compliant material is selected from the group consisting of polyurethane, latex, silicone, and derivatives, combinations, and blends thereof.

53. The hemodialysis system of claim 1, wherein the treatment assembly is adapted to couple to a remotely located energy source and to be actuated by an applied energy field from the energy source to thereby couple the energy between the treatment assembly and the area adjacent to the treatment assembly.

54. The hemodialysis system of claim 1, further comprising:

an energy source that is adapted to be positioned at a location remote from the treatment assembly and to apply an energy field to the treatment assembly; and

wherein the treatment assembly is adapted to couple the energy to the area in response to the applied energy field.

55. The hemodialysis system of claim 20, further comprising:

at least one hemodialysis needle;

wherein the hemodialysis needle is adapted to penetrate the tubular wall of the AV-fistula graft; and

wherein the hemodialysis needle is adapted to allow for fluid communication between the lumen and a hemodialysis pump system.

56. The hemodialysis system of claim 54, further comprising a hemodialysis pump system that is adapted to couple to the at least one hemodialysis needle.

57. The hemodialysis system of claim 20, wherein the AV-fistula graft is further adapted to locally deliver a fluid agent into a region adjacent to the AV-fistula graft.

58. The hemodialysis system of claim 57, further comprising a reservoir coupled to the tubular graft body and that is adapted to house the fluid agent for delivery into the region.

59. The hemodialysis system of claim 58, wherein the reservoir is refillable.

60. The hemodialysis system of claim 57, wherein the AV-fistula graft is adapted to deliver the fluid agent preferentially along the end portion corresponding to the location.

61. The hemodialysis system of claim 57, wherein the region of localized agent delivery from the AV-fistula graft corresponds to the area of energy coupling from the treatment assembly.

62. An AV-fistula graft, comprising:

a tubular graft body having a tubular wall extending between two opposite end portions and a lumen within the tubular wall extending along a longitudinal axis between two fluid ports at the two opposite end portions, respectively; and

a treatment assembly secured to the tubular graft body;

wherein the AV-fistula graft is adapted to couple energy between the treatment assembly and an area adjacent to the treatment assembly sufficient to cause a therapeutic affect when the AV-fistula graft is implanted within a patient with the first and second end portions anastomosed to each of two blood vessels, respectively.

63. The AV-fistula graft of claim 62, wherein the treatment assembly is positioned at the location along the first end portion such that the area corresponds with the anastomosis between the first end portion and the corresponding blood vessel.

64. The AV-fistula graft of claim 62, wherein:

the treatment assembly comprises at least one member that extends from the first end portion of the tubular graft body; and

the member is adapted to cover at least a portion of an anastomosis between the first end portion and a corresponding artery or vein such that the anastomosis is substantially shielded from exposure to blood flow.

65. The AV-fistula graft of claim 62, wherein:

the member comprises a tubular liner that is secured to the first end portion; and

the tubular liner is circumferentially disposed around a longitudinal axis of the lumen at the first end portion.

66. The AV-fistula graft of claim 62, wherein the treatment assembly comprises a plurality of adjacent elongate members positioned around a circumference and extending longitudinally beyond the tubular graft body end.

67. The AV-fistula graft of claim 66, wherein the elongate members are adapted to be positioned to cover a substantial portion of an anastomosis between the tubular graft body end and a respective artery or vein such that the anastomosis is substantially shielded from blood flow.

68. The AV-fistula graft of claim 66, wherein the elongate members are substantially pliable and deflectable in response to blood flow in order to cover the anastomosis region.

69. The AV-fistula graft of claim 65, wherein the at least one member is positioned along only a portion of a circumference surrounding a longitudinal axis of the tubular graft body at the first end portion.

70. The AV-fistula graft of claim 69, wherein the portion is positioned at a location that is adapted to be on a downstream side of an anastomosis between the graft and a corresponding blood vessel.

71. The AV-fistula graft of claim 62, wherein the treatment assembly comprises a material that is adapted to exhibit a material response to an applied energy field from a remotely located energy source such that the treatment assembly is activated to couple the energy to the area.

72. The AV-fistula graft of claim 71, wherein:

the material is adapted to heat in response to energy received from the remotely located energy source; and

the treatment assembly is adapted to thermally couple energy to the area as a result of the heat response of the material.

73. The AV-fistula graft of claim 71, wherein the material is adapted to exhibit the material response to an applied ultrasonic energy field from a remote ultrasound energy source.

74. The AV-fistula graft of claim 71, wherein the material comprises a ferromagnetic material and is adapted to exhibit the material response to an applied magnetic field from a remotely located inductive energy source.

75. The AV-fistula graft of claim 71, wherein the material is adapted to exhibit the material response to applied light energy from a remotely located light energy source.

76. The AV-fistula graft of claim 75, wherein the material is adapted to exhibit the material response to applied ultraviolet light energy from a remotely located ultraviolet light energy source.

77. The AV-fistula graft of claim 75, wherein the material is adapted to exhibit the material response to applied infrared light energy from a remotely located infrared light energy source.

78. The AV-fistula graft of claim 71, wherein the material is adapted to exhibit the material response to an applied electrical current field from a remotely located electrical current source.

79. The AV-fistula graft of claim 62, wherein the treatment assembly is adapted to be actuated by an applied energy field applied across a skin layer of the patient from a remote energy source located externally of the patient when the treatment assembly is positioned at the location along the AV-graft fistula extending between vein and artery anastomoses within the patient'"'"'s body.

80. The AV-fistula graft of claim 62, wherein the treatment assembly is adapted to couple a sufficient amount of energy between the treatment device and the area to substantially inhibit formation of a stenosis associated with an AV-fistula implant along the location.

81. The AV-fistula graft of claim 62, wherein the treatment assembly is adapted to couple a sufficient amount of energy between the treatment assembly and the area to substantially remove at least a portion of a stenosis associated with the AV-fistula implant.

82. The AV-fistula graft of claim 62, wherein the treatment assembly is adapted to couple sufficient energy between the treatment assembly and the area to substantially prevent neo-intimal hyperplasia in the area.

83. The AV-fistula graft of claim 62, wherein the treatment assembly is adapted to couple sufficient energy between the treatment assembly and the area to substantially prevent thrombogenesis or thrombus adhesion in the area.

84. The AV-fistula graft of claim 62, wherein the treatment assembly is adapted to couple the energy between the treatment assembly and a substantially circumferential area adjacent to the treatment assembly.

85. The hemodialysis system of claim 62, wherein

the treatment assembly comprises an adjustable member that is adjustable between a first shape and a second shape;

the first shape has a first outer diameter that is sufficiently small to allow substantially un-occluded fluid communication between the first and second fluid ports and along the lumen; and

the second shape has a second outer diameter that is greater than the first outer diameter to substantially occlude fluid communication between the ports and through the lumen.

86. The hemodialysis system of claim 85, wherein the second outer diameter is sufficient to couple the energy between the adjustable member and a substantially circumferential area that coincides with a circumferential region of an AV-fistula wall.

87. The hemodialysis system of claim 85, wherein:

the adjustable member comprises a radially expandable member that is adjustable between a radially collapsed condition and a radially expanded condition;

the radially collapsed condition characterizes the first shape; and

the radially expanded condition characterizes the second shape.

88. The hemodialysis system of claim 87, wherein the radially expandable member comprises a radially expandable tubular member.

89. The hemodialysis system of claim 88, wherein the radially expandable tubular member comprises an inflatable balloon.

90. An AV-fistula graft, comprising:

a tubular graft body having a first end portion, a second end portion, and a graft lumen extending between first and second ports located at the first and second end portions, respectively; and

means for coupling energy to an area corresponding to the tubular graft body sufficient to cause a therapeutic effect in a patient when the AV-fistula graft is implanted within the patient and extending between two opposite anastomoses associated with a vein and an artery, respectively.

91. The AV-fistula graft of claim 90, wherein the means for coupling energy to the area further comprises means for responding to an applied energy field from a remotely located energy source.

92. The AV-fistula graft of claim 91, wherein the means for coupling energy to the area further comprises means for applying the energy field to the responding means from a remotely located energy source.

93. The AV-fistula graft of claim 92, wherein the applying means comprises means for applying the energy field to the responding means across a skin barrier of the patient.

94. The AV-fistula graft of claim 91, wherein the coupling means further comprises a material that exhibits a material response to the applied energy field.

95. The AV-fistula graft of claim 90, further comprising means for positioning the energy coupling means at a location along the AV-fistula graft during energy coupling to the area from the energy coupling means.

96. An AV-fistula graft having a tubular graft body with a first end portion, a second end portion, and a graft lumen extending between first and second ports located at the first and second end portions, respectively, the first and second end portions being adapted to be anastomosed to a vein and artery, respectively, wherein the improvement comprises:

a treatment assembly positioned at a location along the tubular graft body; and

the treatment assembly is adapted to couple energy between the treatment assembly and an area adjacent to the location sufficient to cause a therapeutic effect in a patient when the AV-fistula graft is implanted within the patient and extending between venous and arterial anastomoses, respectively.

97. The AV-fistula graft of claim 96, wherein

the treatment assembly is permanently secured to the tubular graft body;

and

the treatment assembly is adapted to be implanted within the patient when the tubular graft body extends between the venous and arterial anastomoses.

98. The AV-fistula graft of claim 96, wherein the treatment assembly is adapted to couple the energy to the area in response to an applied ultrasound energy field from a remotely located ultrasound energy source.

99. The AV-fistula graft of claim 96, wherein the treatment assembly is adapted to couple the energy to the area in response to an applied light energy field from a remotely located light energy source.

100. The AV-fistula graft of claim 96, wherein the treatment assembly is adapted to coupe the energy to the area in response to an applied magnetic field from a remotely located inductive energy source.

101. The AV-fistula graft of claim 96, wherein the treatment assembly further comprises:

a member that is adapted to cover at least a portion of the area to shield the portion from blood flow when the energy is coupled to the area

102. The AV-fistula graft of claim 96, wherein the treatment assembly is adapted to couple sufficient energy to the area to inhibit formation of a stenosis along the area.

103. The AV-fistula graft of claim 96, wherein the treatment assembly is adapted to couple sufficient energy to the area to reduce a stenosis located in the area.

104. The AV-fistula graft of claim 96, wherein the treatment assembly is adapted to couple sufficient energy to the area to inhibit at least one of thrombus formation or thrombus adhesion in the area.

105. The AV-fistula graft of claim 96, wherein the treatment assembly is adapted to couple sufficient energy to the area to inhibit neointimal hyperplasia in the area.

106. The AV-fistula graft of claim 96, wherein:

the treatment assembly is adapted to couple sufficient energy to the area to inhibit neointimal hyperplasia; and

the energy is also sufficient to inhibit at least one of thrombus formation or thrombus adhesion in the area.

107. The AV-fistula graft of claim 96, wherein the treatment assembly is adapted to be delivered to the location after the AV-fistula graft is implanted within the patient with the first and second end portions extending between venous and arterial anastomoses, respectively.

108. An AV-fistula graft treatment system, comprising:

a treatment device with a delivery member having an elongate body with a first end portion and a second end portion, and also having a treatment assembly positioned along the first end portion;

wherein the first end portion is adapted to position the treatment assembly at a location within a lumen of an AV-fistula graft; and

wherein the treatment assembly is adapted to couple energy to an area adjacent to the treatment assembly sufficient to cause a therapeutic affect at the location when the AV-fistula graft is implanted within a patient and extending between first and second anastomoses between the first and second end portions, respectively, and first and second blood vessels, also respectively.

109. A system for treating a condition associated with an AV-fistula graft implanted within a patient and extending between first and second anastomoses between the AV-fistula graft and first and second blood vessels, respectively, wherein the system includes an element that is adapted to be positioned at a location along the AV-fistula graft and comprises a material that exhibits a material response to an applied energy field from a remotely located energy source, which material response couples energy to an area adjacent the element sufficient to provide a therapeutic affect to the patient, wherein the improvement comprises:

a treatment assembly that is adapted to be positioned within a graft lumen of the AV-fistula graft at least in part along the location;

the element is provided along the treatment assembly; and

the treatment assembly is adapted to substantially hold the element along the location in order to provide the therapeutic effect.

110. The system of claim 109, wherein the treatment assembly is adapted to be delivered into a lumen of the AV-fistula graft through a hemodialysis needle.

111. The system of claim 109, wherein the treatment assembly with the element and material is adapted to be removed from the area and also from the patient after providing the therapeutic effect.

112. The system of claim 109, further comprising a delivery member with a proximal end portion and a distal end portion, wherein the treatment assembly is located along the distal end portion.

113. The system of claim 112, wherein the distal end portion is adapted to slidably engage and track over a guide wire and to be delivered over the guide wire to the location.

114. The system of claim 112, wherein:

the delivery member further comprises a deflection member coupled to the distal end portion and also to the proximal end portion; and

the distal end portion is deflectable by manipulating the deflection member along the proximal end portion and is adapted to be steered to the location within the AV-fistula graft lumen.

115. The system of claim 109, wherein:

the material is adapted to heat in response to energy received from the remotely located energy source; and

the treatment assembly is adapted to thermally couple energy to the area as a result of the heat response of the material.

116. The system of claim 109, wherein the material is adapted to exhibit the material response to an applied ultrasonic energy field from a remote ultrasound energy source.

117. The system of claim 109, wherein:

the material comprises a ferromagnetic material; and

the ferromagnetic material is adapted to exhibit the material response to an applied magnetic field from a remotely located inductive energy source.

118. The system of claim 109, wherein the material is adapted to exhibit the material response to applied light energy from a remotely located light energy source.

119. The system of claim 109, wherein the material is adapted to exhibit the material response to applied ultraviolet light energy from a remotely located ultraviolet light energy source.

120. The system of claim 109, wherein the material is adapted to exhibit the material response to applied infrared light energy from a remotely located infrared light energy source.

121. The system of claim 109, wherein the material is adapted to exhibit the material response to an applied electrical current field from a remotely located electrical current source.

122. The system of claim 109, wherein the treatment assembly is adapted to be actuated by an applied energy field applied across a skin layer of the patient from a remote energy source located externally of the patient when the treatment assembly is positioned at the location along the AV-graft fistula extending between vein and artery anastomoses within the patient'"'"'s body.

123. The system of claim 109, wherein the treatment assembly is adapted to couple a sufficient amount of energy between the treatment assembly and the area to substantially inhibit formation of a stenosis associated with an AV-fistula implant along the location.

124. The system of claim 109, wherein the treatment assembly is adapted to couple a sufficient amount of energy between the treatment assembly and the area to substantially remove at least a portion of a stenosis associated with the AV-fistula implant.

125. The system of claim 109, wherein the treatment assembly is adapted to couple sufficient energy between the treatment assembly and the area to substantially prevent neo-intimal hyperplasia in the area.

126. The system of claim 109, wherein the treatment assembly is adapted to couple sufficient energy between the treatment assembly and the area to substantially prevent thrombogenesis or thrombus adhesion in the area.

130. The system of claim 129, wherein the passive element comprises a material that is adapted to exhibit a material response to the applied energy field, and the material response is adapted to couple the energy to the area.

133. The method of claim 132, further comprising:

delivering the treatment assembly through a hemodialysis needle in order to position the treatment assembly at the location within AV-fistula graft.

134. The method of claim 132, further comprising:

providing a therapeutic affect to the patient with the energy coupled between the treatment assembly and the area.

135. The method of claim 132, further comprising:

applying the energy field to the treatment assembly with a remotely located energy source through tissue and without physically connecting the energy source and the treatment assembly.

136. The method of claim 135, further comprising:

applying the energy field from the energy source to the treatment assembly transcutaneously across a skin layer of the patient.

137. The method of claim 132, further comprising:

heating the material with the applied energy field; and

coupling thermal energy between the treatment assembly and the area sufficient to provide the therapeutic effect.

138. The method claim 132, wherein the application of the energy field further comprises:

applying an ultrasound energy field to the material from a remotely located ultrasound energy source.

139. The method claim 132, wherein the application of the energy field further comprises:

applying a light energy field to the material from a remotely located light energy source.

140. The method claim 132, wherein the application of the energy field further comprises:

applying a magnetic field to the material from a remotely located inductive energy source.

141. The method claim 132, wherein the application of the energy field further comprises:

applying an electrical field to the material from a remotely located electrical source.

142. The method of claim 132, further comprising:

substantially inhibiting formation of a stenosis associated with an AV-fistula implant along the location with the energy coupled between the treatment assembly and the area.

143. The method of claim 132, further comprising:

removing at least a portion of a stenosis associated with the AV-fistula implant with the energy coupled between the treatment assembly and the area.

144. The method of claim 132, further comprising:

at least in part preventing neo-intimal hyperplasia in the area with the energy coupled between the treatment assembly and the area.

145. The system of claim 132, further comprising inhibiting at least one of thrombogenesis or thrombus adhesion in the area with the energy coupled between the treatment assembly and the area.

147. The method of claim 146, further comprising:

applying an energy field to the treatment assembly at the location and across tissue of the patient from a remotely located energy source.

148. The method of claim 147, wherein the applied energy field is selected from at least one of the following:

an ultrasound energy field, a light energy field, a magnetic energy field, and a electrical energy field.

152. The graft system of claim 151, further comprising a fluid agent stored within the bladder reservoir that is adapted to substantially inhibit formation of a stenosis associated with the AV-fistula graft along the location.

153. The graft system of claim 151, further comprising a fluid agent stored within the bladder reservoir that is adapted to substantially remove at least a portion of a stenosis associated with the AV-fistula implant.

154. The graft system of claim 151, further comprising a fluid agent stored within the bladder reservoir and that is adapted to at least in part prevent neo-intimal hyperplasia in the area.

155. The graft system of claim 151, further comprising a fluid agent stored within the bladder reservoir and that is adapted to inhibit at least one of thrombogenesis or thrombus adhesion in the area.

156. The graft system of claim 151, wherein the bladder reservoir has an annular shape circumscribing the graft lumen and is adapted to deliver the fluid agent into the graft lumen.

157. The graft system of claim 156, wherein the annular bladder reservoir comprises pores located to deliver the agent into the lumen.

158. The graft system of claim 151, wherein

the bladder reservoir is adapted to be fluidly coupled to a remotely located fluid source;

and

the bladder reservoir is adapted to receive a volume of the fluid agent from the source for delivery into the lumen.

159. The graft system of claim 151, wherein the fluid delivery system further comprises:

a second fluid reservoir that is adapted to be fluidly coupled to the bladder reservoir; and

wherein the second fluid reservoir is also adapted to store the volume of fluid agent.

160. The graft system of claim 159, wherein the second fluid reservoir is adapted to be implanted within the patient.

161. The graft system of claim 160, wherein the second fluid reservoir is refillable with a syringe.

163. The AV-fistula graft of claim 162, wherein the local delivery means comprises means for storing the fluid agent along the tubular graft body and means for eluding the fluid agent from the storing means.

164. The system of claim 162, wherein the local delivery means comprises means for substantially inhibiting formation of a stenosis associated with an AV-fistula implant along the location.

165. The system of claim 162, wherein the local delivery means comprises means for substantially removing at least a portion of a stenosis associated with the AV-fistula implant.

166. The system of claim 162, wherein the local delivery means comprises means for at least in part preventing neo-intimal hyperplasia in the area.

167. The system of claim 162, wherein the local delivery means comprises means for inhibiting at least one of thrombogenesis or thrombus adhesion in the area.

169. The graft of claim 168, wherein the valve system comprises:

at least one valve with an expandable member coupled to the AV-fistula lumen and that is adjustable between a radially collapsed condition and a radially expanded condition;

wherein the radially collapsed condition characterizes at least in part the open condition for the valve system and allows for fluid communication between anastomoses associated with the two opposite end portions; and

wherein the radially expanded condition characterizes at least in part the closed condition for the valve system and substantially occludes the fistula lumen.

170. The graft of claim 169, wherein the expandable member comprises an inflatable balloon.

171. The graft of claim 170, wherein the valve system further comprises:

an inflation chamber that is adapted to allow the inflatable balloon to be inflated with pressurized fluid from a hemodialysis needle positioned within the inflation chamber.

172. The graft of claim 171, wherein the inflation chamber is positioned to allow the hemodialysis needle to inflate the balloon during advancement or withdrawal of the hemodialysis needle either respectively before or after performing a hemodialysis procedure with the hemodialysis needle.

173. The graft of claim 169, wherein the valve is located along one of the two opposite end portions of the AV-graft fistula.

174. The graft of claim 169, wherein the valve is located along an intermediate region of the fistula graft between the two end portions adapted to be anastomosed between an artery and a vein, respectively.

175. The graft of claim 169, further comprising:

two said valves positioned along two opposite ends, respectively, of the AV-fistula graft that are adapted to be anastomosed to an artery and vein, also respectively.

176. The graft of claim 175, wherein the two valves are adapted to independently adjusted between the respective open and closed conditions.

177. The graft of claim 175, wherein the two valves are adapted to be adjusted together with a common actuator.

179. The method of claim 178, further comprising:

eluding the fluid agent to a substantially circumferential area circumscribing a lumen of the AV-fistula graft.

180. The method of claim 178, further comprising:

substantially inhibiting formation of a stenosis associated with an AV-fistula implant along the location with the fluid eluding from the bladder reservoir.

181. The method of claim 178, further comprising:

removing at least a portion of a stenosis associated with the AV-fistula implant with the fluid agent eluding from the bladder reservoir.

182. The method of claim 178, further comprising:

at least in part preventing neo-intimal hyperplasia in the area with the fluid agent eluding from the bladder reservoir.

183. The method of claim 178, further comprising inhibiting at least one of thrombogenesis or thrombus adhesion in the area with the fluid eluding from the bladder reservoir.

184. The method of claim 178, further comprising:

securing the bladder reservoir to a tubular graft body of the AV-fistula graft;

fluidly coupling a second reservoir to the bladder reservoir secured to the bladder reservoir;

storing a volume of the fluid agent within the second reservoir;

delivering the volume of the fluid agent from the second reservoir to the bladder reservoir; and

allowing the volume of fluid agent to elude from the bladder reservoir and into the area.

185. The method of claim 184, further comprising:

refilling the second reservoir with a second volume of the fluid agent.

188. The graft of claim 187, wherein the valve system is adapted to allow a volume of a fluid agent to be injected into the reservoir with a hemodialysis needle having its tip located within the reservoir.

189. The graft of claim 187, wherein the second valve assembly comprises a plurality of valves arranged in a grid such that any one of the valves is adapted to be engaged by a hemodialysis needle and is adjustable between respective first and second conditions that characterize the closed and open conditions for the second valve assembly.

190. The graft of claim 187, wherein each of the valves further comprises:

at least one resilient deflection member that is deflectable with force from a hemodialysis needle from a first position to a second position;

wherein the first position characterizes at least in part the first condition for the valve and thus closed condition for the second valve assembly; and

wherein the second position characterizes at least in part the second condition for the valve and thus open condition for the second valve assembly.

191. The graft of claim 190, wherein

each of the valves further comprises a plurality of said resilient deflection members;

each resilient deflection member has different respective first and second positions; and

the plurality of resilient deflection members cooperate such that each of the plurality of resilient deflection members in the first position characterizes the valve in the closed condition, and further such that each of the plurality of resilient deflection members in the second position characterizes the valve in the open condition.

192. The graft of claim 191, wherein:

the plurality of valves are formed at least in part from an integral sheet of material; and

said resilient deflection members comprise portions of the integral sheet of material.

193. The graft of claim 187, wherein the reservoir is adapted to release the volume of fluid agent into the lumen at least at one location along the tubular graft body when the valve system is in the closed condition.

194. The graft of claim 193, wherein the second valve assembly in the closed condition is adapted to allow a controlled release of a fluid agent stored within the reservoir into the lumen.

195. The graft of claim 187, wherein the reservoir is adapted to release the volume of fluid agent into the lumen preferentially along at least one of the two opposite end portions of the tubular graft body that is adapted to be anastomosed to a vein or an artery.

196. The graft of claim 195, wherein the reservoir is adapted to release the volume of fluid agent into the lumen preferentially along the one of the two opposite end portions of the tubular graft body that is adapted to be anastomosed to a vein.

197. The graft of claim 187, further comprising at least one of a thrombolytic or anti-thrombotic fluid agent located within the reservoir.

198. The graft of claim 187, further comprising a fluid agent located within the reservoir that is adapted to inhibit neointimal hyperplasia.

200. The graft of claim 199, further comprising:

means for releasing the stored volume of fluid agent into an area associated with the tubular graft body when the tubular graft body is implanted between arterial and venous anastomoses, respectively, within a patient such that a therapeutic effect is provided to the patient.

127. A system for treating a condition associated with an AV-fistula graft implanted within a patient and extending between first and second anastomoses between the AV-fistula graft and first and second blood vessels, respectively, wherein the system includes an element that is adapted to be positioned at a location within a lumen of the AV-fistula graft and that includes a material that exhibits a material response to an applied energy field from a remotely located energy source such that energy is coupled to an area corresponding to the AV-fistula graft and adjacent to the element that is sufficient to cause a therapeutic affect to the patient, wherein the improvement comprises:

said element does not comprise an echo contrast agent.

128. A system for treating a condition associated with an AV-fistula graft implanted within a patient and extending between first and second anastomoses between the AV-fistula graft and first and second blood vessels, respectively, wherein the system includes an element that is adapted to be positioned at a location within a lumen of the AV-fistula graft and that includes a material that exhibits a material response to an applied energy field from a remotely located energy source such that energy is coupled to an area corresponding to the AV-fistula graft and adjacent to the element that is sufficient to cause a therapeutic affect to the patient, wherein the improvement comprises:

said material is adapted to be substantially held at the location over a period of time sufficient to provide the therapeutic affect.

129. A system for treating a condition associated with an AV-fistula graft implanted within a patient and extending between first and second anastomoses between the AV-fistula graft and first and second blood vessels, respectively, wherein the system includes a treatment assembly that is adapted to be positioned at a location within a lumen of the AV-fistula graft and to couple energy to an area corresponding to the AV-fistula graft and adjacent to the treatment assembly that is sufficient to cause a therapeutic affect to the patient, wherein the improvement comprises:

the treatment assembly comprises a passive element that is adapted to be actuated to couple the energy to the area by exposing the passive element to an energy field from a remotely located energy source.

131. A system for treating a condition associated with an AV-fistula graft implanted within a patient and extending between first and second anastomoses between the AV-fistula graft and first and second blood vessels, respectively, wherein the system includes a treatment assembly that is adapted to be positioned at a location within a lumen of the AV-fistula graft and to couple energy to an area corresponding to the AV-fistula graft and adjacent to the treatment assembly that is sufficient to cause a therapeutic affect to the patient, wherein the improvement comprises:

the treatment assembly is adapted to be introduced into a lumen of the fistula through a hemodialysis needle.

132. A hemodialysis method, comprising:

positioning a treatment assembly along a location within an AV-fistula graft extending between a vein anastomosis and an artery anastomosis;

applying an energy field to a material in the treatment assembly sufficient to cause a material response to the applied energy field such that energy is coupled from the treatment assembly and an area associated with the AV-fistula graft and adjacent to the treatment assembly.

146. A hemodialysis method, comprising:

implanting an AV-fistula graft within a body of a patient and extending between two anastomoses between an artery and a vein, respectively;

positioning a treatment assembly at a location relative to the AV-fistula graft within the patient'"'"'s body;

coupling energy between the treatment assembly and an area associated with the AV-fistula graft and adjacent to the location sufficient to provide a therapeutic affect to the patient; and

implanting the treatment assembly at the location.

149. A hemodialysis method, comprising:

delivering a material into a lumen of an AV-fistula graft extending between first and second anastomoses with an artery and a vein of a patient, respectively, through a hemodialysis needle; and

coupling energy between the material and an area associated with the AV-fistula graft sufficient to cause a therapeutic effect to the patient.

150. An AV-fistula graft, comprising:

a tubular graft body having a tubular wall extending between two opposite end portions and a lumen within the tubular wall extending along a longitudinal axis between two fluid ports at the two opposite end portions, respectively; and

a treatment assembly secured to the tubular graft body;

wherein

the AV-fistula graft is adapted to couple energy between the treatment assembly and an area adjacent to the treatment assembly sufficient to cause a therapeutic affect when the AV-fistula graft is implanted within a patient with the first and second end portions anastomosed to each of two blood vessels, respectively.

151. An AV-fistula graft system, comprising:

a tubular graft body having a first end portion, a second end portion, and a graft lumen extending between first and second ports located at the first and second end portions, respectively;

a fluid delivery assembly with a bladder reservoir coupled to the tubular graft body at a location;

wherein the bladder reservoir is adapted to store a fluid agent; and

wherein the bladder reservoir is adapted to elude the fluid agent into an area corresponding to the tubular graft body and adjacent to the location sufficient to cause a therapeutic effect in a patient when the AV-fistula graft is implanted within the patient and extending between venous and arterial anastomoses, respectively.

162. An AV-fistula graft, comprising:

a tubular graft body having a first end portion, a second end portion, and a graft lumen extending between first and second ports located at the first and second end portions, respectively; and

means for locally delivering a fluid agent into an area corresponding to the tubular graft body sufficient to cause a therapeutic effect in a patient when the AV-fistula graft is implanted within the patient and extending between two opposite anastomoses associated with a vein and an artery, respectively.

168. An AV-fistula graft, comprising:

a tubular graft body having a tubular wall extending between two opposite end portions and a lumen within the tubular wall extending along a longitudinal axis between two fluid ports at the two opposite end portions, respectively; and

a valve system coupled to the lumen and that is adjustable between an open condition and a closed condition with respect to the lumen;

wherein in the open condition the tubular graft body is substantially adapted to allow substantial fluid communication between arterial and a venous anastomoses at the two opposite end portions, respectively; and

wherein in the closed condition the fluid communication between the anastomoses is substantially occluded.

178. A hemodialysis method, comprising:

providing a bladder reservoir that is adapted to couple to an AV-fistula graft;

coupling the bladder reservoir to the AV-fistula graft;

implanting the AV-fistula graft within a body of a patient and extending between first and second anastomoses with a vein and an artery of the patient, respectively;

filling the bladder reservoir with a fluid agent; and

eluding the fluid agent from the bladder reservoir and into an area adjacent to the AV-fistula graft within the patient'"'"'s body.

186. A hemodialysis method, comprising:

adjusting an AV-fistula graft implanted within a body of a patient and extending between arterial and venous anastomoses, respectively, between an open condition and a closed condition;

wherein in the open condition the AV-fistula graft allows substantial fluid communication between the arterial and venous anastomoses; and

wherein in the closed condition the AV-fistula graft substantially prevents fluid communication between the arterial and venous anastomoses.

187. An AV-fistula graft, comprising:

a tubular graft body having a tubular wall extending between two opposite end portions and a lumen within the tubular wall extending along a longitudinal axis between two fluid ports at the two opposite end portions, respectively;

a valve system coupled to the tubular graft body at the location and having, a first valve assembly, a second valve assembly spaced from the first valve assembly and positioned between the first valve assembly and the lumen, and a reservoir located between the first and second valve assemblies;

wherein each of the first and second valve assemblies are adjustable between a closed condition and an open condition;

wherein the valve assemblies are arranged such that with each valve assembly in the open condition a hemodialysis needle may be advanced through the two valve assemblies and into the lumen for performing hemodialysis and may also be withdrawn from the valve assemblies after performing the hemodialysis;

wherein the first valve assembly in the closed condition is adapted to substantially prevent fluid from leaking out from the valve system via the reservoir;

wherein the second valve assembly in the closed condition is adapted to prevent substantial blood leakage from the lumen and into the reservoir; and

wherein the reservoir is adapted to at least temporarily store a volume of a fluid agent when the first and second valve assemblies are in the respectively closed conditions.

199. An AV-fistula graft, comprising:

a tubular graft body having a tubular wall extending between two opposite end portions and a lumen within the tubular wall extending along a longitudinal axis between two fluid ports at the two opposite end portions, respectively; and

means for receiving a volume of a fluid agent from a hemodialysis valve during advancement or withdrawal of a hemodialysis needle into or out of the lumen, respectively, before or after performing hemodialysis with the needle, also respectively; and

means for storing the volume of fluid agent received from the receiving means.

201. A hemodialysis method, comprising:

providing an AV-fistula graft with a valve system that is adapted to allow a hemodialysis needle to be introduced at a location through a tubular graft wall of the graft and into a lumen of the graft and also to seal the lumen from substantial leakage after withdrawal of the hemodialysis needle from the location;

injecting a fluid agent with the hemodialysis needle into a reservoir coupled to the tubular graft wall at the location during advancement of the hemodialysis needle into the lumen through the tubular graft wall prior to performing a hemodialysis procedure or during withdrawal of the hemodialysis needle from the lumen after performing the hemodialysis.

202. The method of claim 201, further comprising:

releasing the fluid agent from the reservoir and into an area adjacent to the tubular graft wall.