Method and apparatus for selective material delivery via an intra-renal catheter

• US 20060036218A1
• Filed: 03/16/2005
• Published: 02/16/2006
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Rosenthal, Michael H., Patel, Samir R., Goodson, Harry B. IV, Aboytes, Ricardo, Valencia, Aurelio, Payne, Sam G., Ball, Craig A., Pesotchinsky, Sophia, Elkins, Jeffrey M., Kesten, Randy J., Kramer, Andrew K.
• Granted Patent: US 7,914,503 B2
• Time in Patent Office: Days
• US Class Current: 604/264
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

Two renal delivery members have two distal ports that are adapted to be positioned within two renal arteries via their corresponding renal ostia at unique locations along an abdominal aortic wall. A proximal coupler assembly is outside the body and is coupled to deliver material to the two distal ports for bi-lateral renal therapy. One or both of the delivery members may be self-cannulating into the corresponding renal ostium, or may be controllably steered into the respective ostium. Non-occlusive anchors may be coupled with one or both of the delivery members at anchoring positions in the renal artery or abdominal aorta to secure the renal delivery member within the renal artery. Renal-active fluid agents are coupled to the bi-lateral delivery system. Another renal therapy system cannulates a renal vein from the vena cava and controls a retrograde delivery of agents to the respective kidney.

Claims

1. A local renal delivery system, comprising:

a first renal delivery member with a first port that is adapted to be delivered to a first delivery position within a first renal artery via a first corresponding renal ostium located at a first location along an abdominal aortic wall of an abdominal aorta in a patient;

a second renal delivery member with a second port that is adapted to be delivered to a second delivery position within a second renal artery via a second corresponding renal ostium located at a second location along the abdominal aorta wall that is different than the first location; and

a proximal coupler assembly that is adapted to be located externally of the patient when the first and second ports are positioned at the first and second delivery positions, respectively;

wherein the proximal coupler assembly is coupled to the first and second ports so as to deliver material from outside the patient'"'"'s body via the proximal coupler assembly, through the first and second ports at the first and second delivery positions, respectively, and into the first and second renal arteries, also respectively.

2. The system of claim 1, further comprising:

an elongate body having a proximal end portion and a distal end portion that is adapted to be delivered to a location within the abdominal aorta when the proximal end portion extends externally from the patient;

wherein the first and second renal delivery members extend from the distal end portion of the elongate body.

3. The system of claim 2, wherein the first and second renal delivery members extend distally from the distal end portion of the elongate body in a bifurcated fashion.

4. The system of claim 3, wherein the first and second renal delivery members extend outward such that tips of the first and second delivery members contact walls of the first and second renal arteries.

5. The system of claim 3, wherein a distance between the first port and the second port is between 2.5 inches and 3.0 inches.

6. The system of claim 5, wherein a distance between a distal end of the elongate body and the apex of an arc of each of the first and second renal delivery members is between 0.90 inches and 1.2 inches.

7. The system of claim 3, wherein each of the first and second renal delivery members assumes a curved configuration upon delivery, and wherein each curved configuration comprises multiple angles and radii of curvature along its length.

8. The system of claim 7, wherein the angles of curvature range between 10°

and 90°

.

9. The system of claim 7, wherein the radii of curvature range between 0.25 inches and 2.5 inches.

10. The system of claim 2, wherein:

the distal end portion of the elongate body comprises first and second ports; and

the first and second renal delivery members are moveable relative to the elongate body and are adjustable to extend from the elongate body through the first and second ports, respectively.

11. The system of claim 10, wherein:

the distal end portion of the elongate body terminates at a distal tip; and

the first and second ports are located at the distal tip; and

the first and second renal delivery members are adjustable to extend distally from the distal tip of the elongate body through the first and second ports, respectively.

12. The system of claim 10, wherein:

the distal end portion of the elongate body extends along a longitudinal axis, has a circumference around the longitudinal axis, and terminates distally at a distal tip;

the first and second ports are located at different positions spaced around the circumference of the elongate body proximally of the distal tip; and

the first and second renal delivery members are adjustable to extend laterally from the elongate body relative to the longitudinal axis through the first and second ports.

13. The system of claim 2, wherein:

the first renal delivery member is substantially fixed and un-adjustable with respect to the elongate body; and

the second renal delivery member is adjustable relative to the elongate body.

14. The system of claim 2, further comprising:

a cannulation assembly located along the distal end portion of the elongate body with a distal end, a proximal end, a length between the proximal and distal ends along a longitudinal axis, a circumference around the longitudinal axis;

wherein the first and second renal delivery members are located along the cannulation assembly at first and second circumferential locations spaced around the circumference;

wherein the cannulation assembly is adapted to be positioned at a location within the abdominal aorta associated with the first and second renal ostia; and

wherein the cannulation assembly is longitudinally collapsible at the location such that the distal and proximal ends of the first and second renal delivery members are brought together with respect to each other; and

upon longitudinal collapse of the cannulation assembly the first and second renal delivery members are biased to extend radially outward from the longitudinal axis at their respective circumferential locations such that the radially extended delivery members are adapted to cannulate the first and second renal arteries via their respective renal ostia along the location, respectively.

15. The system of claim 2, wherein:

the distal end portion of the elongate body has a longitudinal axis and a circumference around the longitudinal axis;

the first and second delivery members comprise two of a plurality of more than two renal delivery members that each extends laterally from the elongate body with a memory shape such that each terminates at a respective distal tip having a unique position circumferentially about the longitudinal axis;

wherein the memory shape of each of the plurality of renal delivery members is adapted to bias the renal delivery member against the abdominal aorta wall at a location along the abdominal aorta corresponding with the first and second renal ostia such that each renal delivery member contacts the wall at a unique lateral location around the circumference of the abdominal aorta wall relative to the other renal delivery members;

wherein the first and second renal delivery members are those renal delivery members of the plurality having their unique lateral locations corresponding with the unique locations of the first and second renal ostia, respectively; and

wherein the system is adapted to isolate delivery of material from outside the patient to only the first and second renal delivery members cannulated into the first and second renal arteries, respectively.

16. The system of claim 15, wherein the distal tips of multiple ones of the plurality of renal delivery members are further adapted to have unique longitudinal locations along the longitudinal axis.

17. The system of claim 15, wherein:

the first and second renal delivery members are adjusted from a first orientation to a second orientation relative to the distal end portion of the elongate body upon cannulation of the first and second renal arteries;

in the first orientation the first and second ports of the first and second renal delivery members are not fluidly coupled to the proximal coupler assembly; and

in the second orientation the first and second ports of the first and second renal delivery members are fluidly coupled to the proximal coupler assembly.

18. The system of claim 1, wherein at least one of the first and second renal delivery members is substantially self-cannulating with respect to the respective renal artery via the corresponding ostium along the abdominal aorta wall.

19. The system of claim 18, wherein the at least one renal delivery member is substantially controllably self-cannulating with respect to the respective renal artery via the corresponding renal ostia.

20. The system of claim 18, wherein the at least one self-cannulating renal delivery member is flow-directed with respect to self-cannulation of the respective renal artery via the corresponding renal ostium along the abdominal aorta wall.

21. The system of claim 18, wherein each of the first and second renal delivery members is self-cannulating with respect to the respective first and second renal arteries via the corresponding first and second respective renal ostia along the abdominal aorta wall.

22. The system of claim 18, wherein the at least one renal delivery member is adapted to recover to a memory shape within the abdominal aorta so as to exert a force radially against the abdominal aorta wall at the recovery position and thereby self-cannulate a renal artery via its ostium when aligned with the recovery position

23. The system of claim 18, wherein:

the at least one renal delivery member is adjustable between a first shape and a second shape that is a memory shape configuration;

the at least one renal delivery member is adjustable to the first shape during placement within a radially confining outer sheath;

the at least one renal delivery member is self-adjustable from the first shape to the second shape when released from radial confinement outside of the radially confining outer sheath; and

the shape recovery toward the second shape is adapted at least in part to self-cannulate a respective renal artery via its respectively aligned renal ostium.

24. The system of claim 1, wherein at least one of the first and second renal delivery members is controllably self-cannulating with respect to the corresponding renal artery via the respective renal ostium, and has a controllable shape that is selectively steerable within the location at least in part by force transmission to the controllably self-cannulating delivery member from a location externally of the patient.

25. The system of claim 24, wherein:

the at least one renal delivery member comprises a pull-wire with a distal end portion and a proximal end portion; and

the distal end portion of the pull-wire is secured to the renal delivery member at a location so as to be positioned with the renal delivery member within the abdominal aorta with the proximal end portion of the pull-wire extending proximally therefrom such that, upon manipulation of the proximal end portion of the pull-wire, the distal end portion of the pull-wire manipulates the shape of the at least one renal delivery member such that the at least one renal delivery member may selectively cannulate the respective renal artery via its corresponding renal ostium.

26. The system of claim 24, wherein:

the at least one renal delivery member has an elongate body with a stylet passageway that houses a stylet that is moveable relative to the elongate body of the at least one renal delivery member;

the elongate body of the at least one renal delivery member is adjustable from a first shape to a second shape by relative movement of the stylet between a first stylet position and a second stylet position, respectively, with respect to the elongate body of the at least one renal delivery member;

the elongate body of the at least one renal delivery member in the first shape is adapted to be delivered into the abdominal aorta through a radially confining outer sheath;

the elongate body of the at least one renal delivery member in the second shape is adapted to cannulate the respective renal artery via the corresponding ostium; and

the relative movement of the stylet relative to the at least one renal delivery member controls the shape of the at least one renal delivery member.

27. The system of claim 26, wherein:

the stylet has a shape; and

the elongate body of the at least one renal delivery member takes the second shape based upon the shape of the stylet.

28. The system of claim 26, wherein:

the second shape comprises a memory shape condition for the elongate body of the at least one renal delivery member; and

the elongate body of the at least one renal delivery member is adjusted from the second shape to the first shape by deflection of the elongate body of the at least one renal delivery member from the memory shape condition with the stylet.

29. The system of claim 1, wherein:

the first renal delivery member is substantially self-cannulating with respect to the first renal artery via the first ostium; and

the second renal delivery member is controllably self-cannulating with respect to the second renal artery via the second ostium and has a controllable shape and is steerable so as to controllably cannulate the second renal artery via the second ostium.

30. The system of claim 1, wherein:

the proximal coupler assembly comprises first and second proximal couplers;

the first proximal coupler is fluidly coupled to the first port; and

the second proximal coupler is fluidly coupled to the second port.

31. The system of claim 1, wherein:

the proximal coupler assembly comprises a single common coupler that is fluidly coupled to each of the first and second ports via a common fluid passageway.

32. The system of claim 1, further comprising:

an anchor that is adjustable from a first configuration to a second configuration;

wherein the anchor in the first configuration is adapted to be delivered to an anchoring position along one of the abdominal aorta or the first renal artery within the patient;

wherein the anchor in the second configuration at the anchoring position is adapted to secure the first renal delivery member with the first port substantially retained at the first delivery position within the first renal artery; and

wherein the anchor in the second configuration at the anchoring position is adapted to allow substantial blood flow across the anchoring position.

33. The system of claim 32, wherein:

the anchor comprises a renal anchor; and

the anchoring position is located along the first renal artery.

34. The system of claim 33, wherein:

the first delivery member comprises a longitudinal axis;

the anchor comprises a shapeable section of the first delivery member that is adjustable between first and second shapes that correspond with the first and second configurations, respectively, for the anchor; and

the anchor is adjustable from the first shape to the second shape at the anchoring position such that the second shape is biased to radially extend from the longitudinal axis of the first delivery member and is adapted to engage a wall of the first renal artery with sufficient force to secure the first delivery member with the first port at the first delivery position.

35. The system of claim 34, wherein:

the anchor further comprises a pull-wire with a distal end portion and a proximal end portion; and

the distal end portion of the pull-wire is secured to the renal delivery member at a fixed location corresponding with the shapeable section of the first delivery member;

the proximal end portion of the pull-wire extends proximally from the fixed location such that, upon manipulation of the proximal end portion of the pull-wire, the distal end portion of the pull-wire manipulates the shape of the first renal delivery member from the first shape to the second shape.

36. The system of claim 34, wherein:

the first renal delivery member has a stylet passageway that houses a stylet that is moveable relative to the shapeable section; and

the shapeable section is adjustable from the first shape to the second shape by relative movement of the stylet between a first stylet position and a second stylet position, respectively, within the stylet passageway along the shapeable section.

37. The system of claim 36, wherein:

the stylet has a shape; and

the shapeable section is deflectable from the first shape to the second shape by the shape of the stylet.

38. The system of claim 37, wherein:

the second shape comprises a memory shape condition for the shapeable section; and

the shapeable section is deflectable from the second shape to the first shape by adjusting the relative position of the stylet.

39. The system of claim 33, wherein:

the first delivery member comprises proximal and distal sections that are located proximally and distally adjacent to the shapeable section; and

when the anchor is in the second shape at the anchoring position the proximal and distal sections are positioned along opposite sides of the renal artery wall.

40. The system of claim 33, wherein:

the first delivery member comprises proximal and distal sections that are located proximally and distally adjacent to the shapeable section; and

when the anchor is in the second shape at the anchoring position the proximal and distal sections are positioned along one side of the renal artery wall and the shapeable section is biased against a second opposite side of the renal artery wall.

41. The system of claim 32, wherein:

the first delivery member comprises an elongate body with a longitudinal axis;

the anchor comprises a radially extendable member located along the elongate body and that is adjustable between first and second shapes that correspond with the first and second configurations for the anchor;

the radially extendable member in the second shape is biased to radially extend from the elongate body relative to the first shape and is adapted to radially engage a wall of the first renal artery with sufficient force to secure the first delivery member within the first renal artery with the first delivery port at the first delivery position.

42. The system of claim 41, wherein:

the radially extendable member extends at least in part between proximal and distal locations that are spaced by a distance along an outer surface of the elongate body and where the radially extendable member is respectively engaged with the elongate body;

the proximal location comprises a port that communicates with a lumen within the elongate body;

the radially extendable member has a length between a proximal portion and a distal portion that is longer than the distance between proximal and distal locations;

in the first shape the proximal portion of the radially extendable member extends proximally within the port and proximally along the lumen to an internal location such that the length extends between the internal location and the distal location; and

in the second shape the proximal portion of the radially extendable member is advanced distally from the internal location to generally correspond with the port at the proximal location such that the length of the radially extendable member extends along a radially extended path between the proximal and distal locations externally of the elongate body within the first renal artery.

43. The system of claim 42, wherein the radially extendable member extends directly between the proximal and distal locations in the first shape.

44. The system of claim 42, wherein:

the radially extendable member extends around a circumference of the elongate body between the proximal and distal locations;

the first shape of the radially extendable member is wrapped around the elongate body between the proximal and distal locations; and

the second shape of the radially extendable member comprises an arc that is adapted to engage the wall of the first renal artery over a portion of the circumference of the first renal artery wall.

45. The system of claim 41, wherein:

the second shape comprises a memory shape for the radially extendable member;

the radially extendable member is adjustable to the first shape within a radially confining outer sheath; and

the radially extendable member is self-adjustable at the anchoring position from the first shape to the second shape by releasing the radially extendable member from radial confinement.

46. The system of claim 45, wherein the second shape is a partial loop shape that extends along an arc between first and second locations around the circumference of the elongate body.

47. The system of claim 41, wherein:

the radially extendable member is a first radially extendable member and the partial loop shape extends along an arc along one side of the elongate body; and

the anchor further comprises a second said radially extendable member with a second shape that is a partial loop shape that extends along an arc along an opposite side of the elongate body; and

the first and second partial loop shapes are adapted to engage the first renal artery wall on opposite sides with the elongate body located within the first renal artery therebetween.

48. The system of claim 41, wherein:

the radially extendable member comprises an inflatable balloon that is adjustable between a deflated configuration and an inflated configuration;

the deflated configuration characterizes the first shape; and

the inflated configuration characterizes the second shape.

49. The system of claim 48, wherein the second shape characterized by the inflated condition for the balloon has a non-circular cross-section.

50. The system of claim 49, wherein the second shape comprises an oblong lobe with a first diameter that spans across the first renal artery transverse to the longitudinal axis of the first renal artery so as to engage to the first renal artery wall with sufficient force to anchor the first renal delivery member there, but with a second diameter transverse to the first diameter that is less than the diameter of the first renal artery, such that the oblong lobe does not completely occlude the first renal artery at the anchoring position.

51. The system of claim 50, wherein the second shape comprises a plurality of said oblong lobes that are arranged about the circumference of the elongate body in spaced arrangement relative to each other such that in the second shape each oblong lobe is adapted to radially engage a unique portion of the first renal artery wall, and such that blood is allowed to flow in the spaces between the adjacent oblong lobes.

52. The system of claim 41, wherein:

the elongate body comprises a circumference around the longitudinal axis; and

the anchor further comprises a plurality of said radially extendable members that are located at spaced intervals around the circumference of the elongate body;

such that each radially extendable member in the second shape is adapted to engage the wall of the first renal artery at a different location around the circumference of the first renal artery relative to the other radially extendable members.

53. The system of claim 31, wherein:

the anchor comprises an aortic anchor; and

the anchoring position is located along the abdominal aorta.

54. The system of claim 53, wherein:

the anchor comprises a shapeable section of the first renal delivery member that is adjustable between first and second shapes that correspond with the first and second configurations, respectively, for the anchor;

the first delivery member comprises proximal and distal sections located proximally and distally adjacent the shapeable section and that includes the first port;

the distal section includes the first port and is adapted to be positioned within the first renal artery with the first port at the first delivery location and with the shapeable section located along the anchoring position within the abdominal aorta;

the proximal section extends along a longitudinal axis where it transitions to the shapeable section; and

the shapeable section is adjustable from the first shape to the second shape at the anchoring position such that the second shape is biased to radially extend from the longitudinal axis and is adapted to engage a wall of the abdominal aorta at the anchoring position with sufficient force to secure the first delivery member with the first port at the first delivery position.

55. The system of claim 54, wherein:

the shapeable section comprises a proximal region and a distal region;

in the second shape the proximal region is radially biased to a first side of the longitudinal axis so as to contact a first side of the abdominal aorta wall;

in the second shape the distal region is radially biased to a second side generally opposite the first side of the longitudinal axis so as to contact a second side generally opposite the first side of the abdominal aorta wall; and

the proximal and distal regions cooperate to apply generally opposite forces against the first and second sides of the abdominal aorta wall to thereby anchor the first delivery member at that location.

56. The system of claim 54, wherein the distal region forms a loop that extends from the proximal region along the first side of the abdominal aorta, arcs across the abdominal aorta to engage the second side of the abdominal aorta, and arcs back across the abdominal aorta from the second side toward the first side, and the distal section extends from the distal region extending across the abdominal aorta and into the first renal artery via the first renal ostium.

57. The system of claim 31, wherein the anchor comprises a first anchor, and the anchoring position is a first anchoring position, and further comprising:

a second anchor that is adjustable from a first configuration to a second configuration;

wherein the second anchor in its respective first configuration is adapted to be delivered to a second anchoring position along one of either the abdominal aorta or the second renal artery within the patient;

wherein the second anchor in its respective second configuration at the second anchoring position is adapted to secure the second renal delivery member with the second port substantially retained at the second delivery position within the second renal artery; and

wherein the second anchor in its respective second configuration at the second anchoring position is constructed so as to allow substantial blood flow from the abdominal aorta and along the second renal artery to the kidney.

58. The system of claim 57, wherein:

the first anchor is a renal anchor;

the first anchoring position is within the first renal artery;

the second anchor is a renal anchor; and

the second anchoring position is within the second renal artery.

59. The system of claim 57, wherein:

the first anchor is an aortic anchor;

the first anchoring position is within the abdominal aorta;

the second anchor is an aortic anchor; and

the second anchoring position is within the abdominal aorta.

60. The system of claim 57, wherein:

the first anchor is a renal anchor;

the first anchoring position is within the first renal artery;

the second anchor is an aortic anchor; and

the second anchoring position is within the abdominal aorta.

61. The system of claim 1, further comprising:

a source of material;

wherein the first delivery member is adapted to deliver the material from a location externally of the patient through the first delivery port at the first delivery position and into the first renal artery.

62. The system of claim 61, wherein the source of material comprises a fluid agent.

63. The system of claim 62, wherein the fluid agent comprises a renal protective agent.

64. The system of claim 62, wherein the fluid agent comprises a diuretic.

65. The system of claim 64, wherein the diuretic comprises Furosemide or an analog or derivative thereof.

66. The system of claim 64, wherein the diuretic comprises Thiazide or an analog or derivative thereof.

67. The system of claim 62, wherein the fluid agent comprises a vasopressor.

68. The system of claim 67, wherein the vasopressor comprises Dopamine or an analog or derivative thereof.

69. The system of claim 62, wherein the fluid agent comprises a vasodilator.

70. The system of claim 62, wherein the fluid agent comprises a vasoactive agent.

71. The system of claim 62, wherein the fluid agent comprises papaverine or an analog or derivative thereof.

72. The system of claim 71, wherein the fluid agent comprises a calcium-channel blocker.

73. The system of claim 62, wherein the fluid agent comprises Nifedipine or an analog or derivative thereof.

74. The system of claim 62, wherein the fluid agent comprises Verapamil or an analog or derivative thereof.

75. The system of claim 62, wherein the fluid agent comprises fenoldapam mesylate or an analog or derivative thereof.

76. The system of claim 62, wherein the fluid agent comprises a dopamine DA1 agonist.

77. The system of claim 1, wherein the first and second renal delivery assemblies together comprise a bi-lateral renal delivery system, and further comprising:

a vascular access system with an elongate tubular body with at least one lumen extending between a proximal port and a distal port that is adapted to be positioned within a vessel having translumenal access to a location along the abdominal aorta associated with the first and second renal ostia when the proximal port is located externally of the patient;

a percutaneous translumenal interventional device that is adapted to be delivered to an intervention location across the location while the first and second ports are located at the first and second delivery positions, respectively; and

wherein the bilateral renal delivery assembly and percutaneous translumenal interventional device are adapted to be delivered percutaneously into the vessel through the vascular access device, and are also adapted to be simultaneously engaged within the vascular access device.

78. The system of claim 77, wherein the percutaneous translumenal interventional device comprises an angiographic catheter.

79. The system of claim 77, wherein the percutaneous translumenal interventional device comprises a guiding catheter.

80. The system of claim 77, wherein the percutaneous translumenal interventional device is between about 4 French and about 8 French.

81. The system of claim 1, further comprising:

first and second markers located on each of the first and second delivery members at locations corresponding with the first and second ports, and which are adapted to indicate the location of the first and second ports within the abdominal aorta with respect to the location.

82. The system of claim 81, wherein:

the first and second markers extend in bifurcated arrangement from the distal end portion of the elongate body at a bifurcation location.

83. The system of claim 82, wherein

a proximal marker is provided at the bifurcation location;

and

wherein the proximal marker is adapted to indicate the position of the bifurcation location with respect to a distal tip of an abdominal aorta introducer sheath.

84. The system of claim 82, wherein:

the first and second delivery members comprise first and second elongate bodies that are adapted to have a first relative shape and orientation so as to be positioned and delivered to the location within a radially confining sheath;

the delivery members also have shape memories to a second relative shape and orientation upon withdrawal of the radially confining sheath so as to extend along opposite shaped curves that diverge substantially along a plane.

85. The system of claim 1, wherein:

each of the first and second delivery members comprises a wire-reinforced composite tubing.

86. The system of claim 1, further comprising:

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

wherein each of the first and second delivery members has a proximal section that extends from the distal end portion with a first curve along a first radius; and

wherein each of the first and second delivery members has a distal section that extends from the proximal section with a second curve opposite the first curve along a second radius.

87. The system of claim 86, wherein the second radius is smaller than the first radius.

88. The system of claim 86, wherein each of the first and second delivery members terminates at a tip member that is constructed of a softer material than adjacent material along the respective member.

89. A method for treating a renal system in a patient, comprising:

positioning a first port of a first renal delivery member at a first delivery position within a first renal artery via a first corresponding renal ostium located at a first location along an abdominal aorta wall of an abdominal aorta in a patient;

positioning a second port of a second renal delivery member at a second delivery position within a second renal artery via a second corresponding renal ostium located at a second location along the abdominal aortic wall that is different than the first location;

positioning a proximal coupler assembly externally of the patient when the first and second ports are positioned at the first and second delivery positions, respectively; and

delivering a material from outside the patient'"'"'s body via the proximal coupler assembly, through the first and second ports at the first and second delivery positions, respectively, and into the first and second renal arteries, also respectively.

90. A method for treating a renal system in a patient, comprising:

delivering a distal port of a renal delivery member to a delivery position within a renal artery via a corresponding renal ostium along an abdominal aortic wall;

positioning a proximal coupler assembly externally of the patient when the distal port is positioned at the delivery position;

delivering an anchor in a first configuration to an anchoring position along one of the abdominal aorta or the renal artery within the patient;

adjusting the anchor at the anchoring position from the first configuration to a second configuration that secures the renal delivery member with the distal port substantially retained at the delivery position within the renal artery;

allowing substantial blood flow across the anchoring position when the anchor is in the second configuration at the anchoring position; and

delivering material from outside the patient'"'"'s body via the proximal coupler assembly, through the distal port at the delivery position and into the renal artery.

91. A method for treating a renal system in a patient, comprising:

positioning a distal port of a tubular body of a vascular access system within a vessel having transvascular access to a location along an abdominal aorta associated with first and second renal ostia when a proximal port of the tubular body is located externally of the patient;

introducing first and second renal delivery members of a bi-lateral local renal delivery assembly into the vessel through the tubular body;

delivering first and second ports of the first and second renal delivery members, respectively, to first and second respective delivery positions within first and second renal arteries, respectively, via the first and second renal ostia, also respectively;

introducing a percutaneous translumenal interventional device into the vessel through the tubular body;

delivering a distal end portion of the percutaneous translumenal interventional device to an intervention location across the location while the first and second ports are located at the first and second delivery positions, respectively; and

simultaneously delivering material from an external location relative to the patient and directly into each of first and second renal arteries via the first and second ports at the first and second delivery positions, respectively; and

wherein the bi-lateral renal delivery assembly and a proximal end portion of the percutaneous translumenal interventional device are simultaneously engaged within the tubular body of the vascular access assembly when the first and second ports are at the first and second delivery positions and the distal end portion of the percutaneous translumenal interventional device is at the intervention location.

92. A method for preparing a bi-lateral renal delivery system for use in treating a patient, comprising:

introducing first and second renal delivery members of a bi-lateral local renal delivery assembly into a tubular body of a vascular access system;

introducing a percutaneous translumenal interventional device into the tubular body;

wherein the bi-lateral renal delivery assembly and the percutaneous translumenal interventional device are simultaneously engaged within the tubular body of the vascular access assembly;

wherein the first and second renal delivery members have first and second ports, respectively, that are adapted to be delivered to first and second respective delivery positions within first and second renal arteries, respectively, via first and second renal ostia, also respectively, having unique locations along the abdominal aorta wall;

wherein the percutaneous translumenal interventional device comprises a distal end portion that is adapted to be delivered to an intervention location across a location along the abdominal aorta associated with the first and second renal ostia while the first and second ports are located at the first and second delivery positions, respectively; and

wherein the first and second renal delivery members are coupled to a proximal coupler assembly that is adapted to deliver material from an external location relative to the patient and to the first and second ports so as to deliver the material directly into each of first and second renal arteries via the first and second ports at the first and second delivery positions, respectively; and

wherein the tubular body of the vascular access system has a distal port that is adapted to be positioned within a vessel having transvascular access to the location along the abdominal aorta when a proximal port of the tubular body is located externally of the patient.

93. A method for treating a renal system in a patient, comprising:

delivering a distal port of a renal delivery member to a delivery position within a renal vein via its ostium along a vena cava in a patient;

positioning a proximal coupler assembly externally of the patient when the distal port is at the delivery position;

fluidly coupling the proximal coupler assembly to the distal port such that a material may be delivered from outside of the patient through the proximal coupler assembly, through the distal port at the delivery position, and into the renal vein;

delivering an occlusion member in a first configuration to an occlusion position located toward ostium from the delivery position, such that the distal port and occlusion members are located at the delivery and occlusion positions, respectively;

adjusting the occlusion member at the occlusion position from the first configuration to a second configuration so as to substantially occlude flow from the renal vein and into the vena cava;

controlling co-operative operation of the renal delivery assembly and the occlusion member between first and second modes of operation;

wherein in the first mode the occlusion member is in the first configuration at the occlusion position and venous blood is allowed to flow from the kidney and along the renal vein and into the vena cave; and

wherein in the second mode the occlusion member is in the second configuration at the occlusion position, venous blood is substantially occluded from flowing from the kidney along the renal vein and into the vena cava, and a volume of fluid agent flows through the distal port at the delivery position and into the renal vein at sufficient pressure to provide retrograde flow into the respective kidney coupled to the renal vein.

94. A method for treating a renal system in a patient, comprising:

positioning an introducer sheath within an abdominal aorta at a location associated with first and second renal artery ostia associated with first and second renal arteries that perfuse first and second kidneys in the patient;

delivering a bi-lateral renal delivery assembly in a first configuration under radial confinement through the introducer sheath and to a first position along the location;

withdrawing the introducer with respect to the bi-lateral renal delivery assembly so as to remove the radial confinement;

after removing the bi-lateral renal delivery assembly from radial confinement, allowing first and second bifurcating delivery members to self-expand apart from each other and radially against an abdominal aorta wall at the location with shape memory recovery force to a second configuration;

modifying the position of the self-expanded renal delivery assembly so as to self-cannulate at least one of the delivery members into at least one of the renal arteries via its corresponding ostium along the abdominal aorta wall.

95. The method of claim 94, further comprising torquing the renal delivery assembly in the second configuration.

96. The method of claim 94, further comprising modifying the longitudinal position of the renal delivery assembly in the second configuration.

97. A method for providing local therapy to a renal system in a patient, comprising:

delivering a bi-lateral local renal delivery assembly to a location within an abdominal aorta corresponding with first and second renal ostium along an abdominal aorta wall of the patient;

delivering a percutaneous translumenal interventional device to an intervention location across the location corresponding with the renal ostia;

positioning a first delivery member of the bilateral local renal delivery assembly in a first renal artery via a first ostium along the abdominal aorta wall;

positioning a second delivery member of the bilateral local renal delivery assembly in a second renal artery via a second ostium along the abdominal aorta wall;

inserting the bi-lateral local renal delivery assembly and percutaneous translumenal interventional device into the patient'"'"'s vasculature through a common vascular access site.

98. A system for providing local renal therapy in a patient, comprising:

an introducer sheath with a proximal end portion and a distal end portion that is adapted to be positioned at a location within an abdominal aorta associated with first and second renal ostia of first and second renal arteries, respectively, while the proximal end portion extends externally from the patient, and also with an introducer lumen extending between a proximal port located along the proximal end portion and a distal port located along the distal end portion;

a local injection assembly with an injection port assembly that is adapted to be delivered to the location through the introducer lumen and through the distal port in a first condition;

wherein the local injection assembly is adapted to be adjusted at the location from the first condition to a second condition that is advanced externally through the distal port at the location;

wherein in the second condition at the location the local injection assembly is adapted to be fluidly coupled to a source of fluid agent located externally from the patient;

wherein the second condition at the location the local injection assembly is adapted to position the injection port assembly so as to inject a volume of fluid agent substantially bilaterally into each of the two renal arteries; and

further comprising means for monitoring a position of at least one of the injection port assembly or the distal port relative to at least one of the renal ostia without use of fluoroscopic or X-ray imaging.

99. The system of claim 98, wherein the means for monitoring comprises:

at least one marker at a location that is adapted to indicate the location of at least one of the injection port assembly or the distal port with respect to a non-fluoroscopic sensor assembly located externally of the location.

100. The system of claim 99, wherein the at least one marker comprises an ultrasonically visible marker.

101. The system of claim 100, wherein the means for monitoring further comprises an ultrasound imaging sensor that is adapted to be positioned at a second location sufficient to monitor the location of the ultrasonically visible marker at the location.

102. The system of claim 98, wherein the at least one marker comprises a marker located along the distal end portion of the introducer sheath and that is adapted to indicate the relative location of the distal port within the location relative to at least one renal ostium.

103. The system of claim 98, wherein:

the local injection assembly comprises first and second injection ports that are adapted to be delivered to first and second positions such that the volume of fluid agent is injected substantially into the first and second renal arteries via the first and second injection ports, respectively, at the first and second positions, also respectively; and

the at least one marker comprises first and second markers that are positioned relative to the first and second injection ports, respectively, so as to indicate the relative position of the injection ports relative to the first and second positions, also respectively.

104. The system of claim 103, wherein:

the local injection assembly comprises first and second injection members;

the first and second injection ports are located along the first and second injection members, respectively; and

the first and second markers are located at first and second locations along the first and second injection members relative to the first and second injection ports.

105. The system of claim 98, wherein the means for monitoring comprises:

a sensor assembly that is adapted to cooperate with at least one of the local injection assembly or the distal port of the introducer sheath such that the sensor assembly is adapted to be positioned within the location and to sense a parameter indicative of the relative position of the local injection assembly or distal port relative to the renal ostia at the location.

106. The system of claim 105, wherein the sensor assembly comprises a sensor located along the distal end portion of the introducer sheath and is adapted to sense a parameter that is indicative of a relative location of the distal port relative to at least one renal ostium.

107. The system of claim 105, wherein the sensor assembly comprises at least one sensor located at a position relative to the injection port assembly so as to indicate the relative position of the injection port assembly.

108. The system of claim 107, wherein:

the local injection assembly comprises first and second injection ports that are adapted to be delivered to first and second positions such that the volume of fluid agent is injected substantially into the first and second renal arteries via the first and second injection ports, respectively, at the first and second positions, also respectively; and

the at least one sensor comprises first and second sensors that are positioned relative to the first and second injection ports, respectively, so as to indicate the relative position of the injection ports relative to the first and second positions, also respectively.

109. The system of claim 108, wherein:

the local injection assembly comprises first and second injection members;

the first and second injection ports are located along the first and second injection members, respectively; and

the first and second sensors are located at first and second locations along the first and second injection members relative to the first and second injection ports.

110. The system of claim 105, wherein the sensor assembly comprises an ultrasound sensor.

111. The system of claim 105, wherein the sensor assembly comprises an Doppler ultrasound sensor.

112. The system of claim 105, wherein the sensor assembly comprises an optical sensor.

113. The system of claim 105, wherein the sensor assembly comprises a pressure sensor.

114. The system of claim 105, wherein the sensor assembly comprises a flow velocity sensor.

115. The system of claim 105, wherein the sensor assembly comprises a flow rate sensor.

116. The system of claim 105, wherein the sensor assembly comprises a chemical sensor.

117. The system of claim 105, further comprising a monitoring assembly located externally of the patient and that is adapted to couple to the sensor assembly at the location and to monitor at least one sensed parameter that is sensed by the sensor assembly at the location.

118. The system of claim 117, further comprising a display that is adapted to display the monitored parameter.

119. The system of claim 118, further comprising indicia for indicating a desired relative position of the sensor assembly relative to at least one renal ostium.

120. A method for providing local renal therapy in a patient, comprising:

delivering a distal end portion of an introducer sheath to a location within an abdominal aorta associated with first and second renal ostia of first and second renal arteries, respectively, while a proximal end portion of the introducer sheath extends externally from the patient, and also such that an introducer lumen within the introducer sheath extends between a proximal port located along the proximal end portion and a distal port located along the distal end portion at the location;

delivering a local injection assembly with an injection port assembly to the location through the introducer lumen and through the distal port in a first condition;

adjusting the local injection assembly at the location from the first condition to a second condition that is advanced externally through the distal port at the location;

fluidly coupling the local injection assembly in the second condition at the location to a source of fluid agent located externally from the patient;

positioning the injection port assembly so as to inject a volume of fluid agent from the source substantially bilaterally into each of the two renal arteries; and

sensing a parameter indicative of a position of at least one of the injection port assembly or the distal port relative to at least one of the renal ostia without use of fluoroscopic or X-ray imaging.

121. The method of claim 120, further comprising sensing the position with an ultrasound sensor.

122. The method of claim 120, further comprising sensing the position with a Doppler ultrasound sensor.

123. The method of claim 120, further comprising sensing the position by sensing an optical parameter with an optical sensor.

124. The method of claim 120, further comprising sensing the position by sensing a pressure parameter with a pressure sensor.

125. The method of claim 120, further comprising sensing the position by sensing a velocity of blood flow with a flow velocity sensor.

126. The method of claim 120, further comprising sensing the position by sensing a blood flow rate with a flow rate sensor.

127. The method of claim 120, further comprising sensing the position by sensing a chemical parameter of blood with a chemical sensor.

128. The method of claim 120, further monitoring the sensed parameter externally of the patient.

129. The method of claim 128, further comprising displaying the monitored parameter.

130. The method of claim 129, further comprising providing indicia of the relationship of the monitored parameter in relation to a desired value of the monitored parameter indicating the sensed position is a desired position.