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

• US 8,012,121 B2
• Filed: 06/26/2007
• Issued: 09/06/2011
• Est. Priority Date: 09/20/2002
• Status: Expired due to Fees

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Kramer, Andrew K., 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.
• Primary Examiner(s): Stigell; Theodore J
• Assistant Examiner(s): Anderson; Michael J
• Application Number:
  US11/768,390
• Publication Number:
  US 20070249997A1
• Time in Patent Office: 1,533 Days
• Field of Search: 604/93.01, 604/96.01, 604/101.01, 604/264, 623/1.35
• US Class Current: 604/93.01
• 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 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The method of claim 6, further comprising torquing the renal delivery assembly in the second configuration.

8. The method of claim 6, further comprising modifying the longitudinal position of the renal delivery assembly in the second configuration.

9. 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.