Intra-aortic renal drug delivery catheter

• US 20040064089A1
• Filed: 04/23/2003
• Published: 04/01/2004
• Est. Priority Date: 11/28/2000
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Rosenthal, Michael H., Payne, Sam G., Pesotchinsky, Sophia, Kesten, Randy J., Kramer, Andrew K.
• Granted Patent: US 7,481,803 B2
• Time in Patent Office: Days
• US Class Current: 604/93.01
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• 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 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61P 13/12 of the kidneys

Abstract

A catheter for delivering a therapeutic or diagnostic agent to a branch blood vessel of a major blood vessel, generally comprising an elongated shaft having at least one lumen in fluid communication with an agent delivery port in a distal section of the shaft, an expandable tubular member on the distal section of the shaft, and a radially expandable member on the tubular member. The tubular member is configured to extend within the blood vessel up-stream and down-stream of a branch vessel, and has an interior passageway which is radially expandable within the blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member. The radially expandable member is located down-stream of the shaft agent delivery port, and has an expanded configuration with an outer diameter larger than an outer diameter of the tubular member. The expanded radially expandable member is configured to decrease the blood flow in the outer blood flow stream down-stream of the branch vessel. The catheter provides for delivery of an agent to a branch vessel of a major vessel, and continuous perfusion of the major blood vessel. Another aspect of the invention is directed to methods of delivering a therapeutic or diagnostic agent to one or both kidney'"'"'s of a patient.

Claims

1. A catheter for controlling blood flow to a branch vessel of a blood vessel, comprising:

a) an elongated shaft;

b) a tubular member on a distal section of the shaft having an interior passageway which is radially expandable within a blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member, and which is configured to extend within the blood vessel upstream and downstream of a branch vessel; and

c) a radially expandable member on the tubular member, having an expanded configuration with an outer diameter larger than an outer diameter of the tubular member and which is configured to direct at least part of the blood flow in the outer blood flow stream into the branch vessel.

2. The catheter of claim 1 wherein the elongated shaft has at least one lumen therein in fluid communication with at least one agent delivery port in a distal section of the shaft, and wherein the radially expandable member is downstream of the agent delivery port.

3. The catheter of claim 2 wherein the tubular member has an upstream end located upstream of the agent delivery port.

4. The catheter of claim 2 wherein the tubular member has a distal end located distal to the agent delivery port.

5. The catheter of claim 2 wherein the agent delivery port is a lateral port in a side wall of the shaft.

6. The catheter of claim 1 wherein the radially expandable member comprises an inflatable balloon, and the shaft includes an inflation lumen and an inflation port in fluid communication with an interior of the balloon.

7. The catheter of claim 1 wherein the radially expandable member comprises a radially enlarged section of the tubular member.

8. The catheter of claim 1 wherein the tubular member comprises a braided tube having a sheath.

9. The catheter of claim 8 including a pull line having a distal end attached to the tubular member, and wherein the interior passageway of the tubular member is radially expanded by proximally retracting the pull line.

10. The catheter of claim 1 wherein the tubular member is self expanding.

11. The catheter of claim 10 wherein the tubular member comprises a radially collapsible frame having a sheath.

12. The catheter of claim 10 wherein the tubular member comprises a sheet configured to unwind from a wound low profile configuration to an unwound radially expanded configuration to thereby radially expand the interior passageway of the tubular member.

13. The catheter of claim 1 wherein the tubular member comprises a plurality of tubular balloons joined together, each tubular balloon being joined to adjacent tubular balloons along a length thereof to thereby define the tubular member interior passageway.

14. The catheter of claim 1 wherein the tubular member is conically shaped having a smaller diameter end and a larger diameter end

15. The catheter of claim 14 wherein the radially expandable member is formed by the larger diameter end of the conical tubular member.

16. The catheter of claim 1 wherein the interior passageway of the tubular member has an expanded inner diameter of about 30 mm to about 130 mm.

17. The catheter of claim 1 wherein the interior passageway of the tubular member has an unexpanded inner diameter configured to expand to an expanded inner diameter, wherein the expanded inner diameter is about 1000% to about 6000% larger than the unexpanded inner diameter.

18. A method of controlling blood flow to a branch vessel of a blood vessel, comprising:

a) providing a catheter comprising

i) an elongated shaft;

ii) a tubular member on the distal section of the shaft having an interior passageway which is radially expandable within a blood vessel, and which is configured to extend within the blood vessel upstream and downstream of a branch vessel; and

iii) a radially expandable member on the tubular member, having an expanded configuration with an outer diameter larger than an outer diameter of the tubular member and which is configured to decrease the blood flow in the outer blood flow stream downstream of the branch vessel; and

b) advancing a distal portion of the catheter within the patient'"'"'s descending aorta, so that an upstream end of the tubular member is upstream of the branch vessel and the radially expandable member is downstream of the branch vessel;

c) expanding the tubular member to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member; and

d) expanding the radially expandable member to the expanded configuration to thereby decrease the blood flow in the outer blood flow stream downstream of the at least one renal artery.

19. The method of claim 18 including expanding the radially expandable member into contact with a wall of the blood vessel to occlude the outer blood flow stream downstream of the branch vessel.

20. The method of claim 18 including expanding the radially expandable member to an outer diameter which does not completely occlude the outer blood flow stream downstream of the branch vessel.

21. A catheter for delivering a therapeutic or diagnostic agent to a branch vessel of a blood vessel, comprising:

a) an elongated shaft having at least one lumen therein in fluid communication with at least one agent delivery port in a distal section of the shaft;

b) a tubular member on the distal section of the shaft having an interior passageway which is radially expandable within a blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member, and which is configured to extend within the blood vessel upstream and downstream of a branch vessel; and

c) a radially expandable member on the tubular member, downstream of the shaft agent delivery port, having an expanded configuration with an outer diameter larger than an outer diameter of the tubular member and which is configured to decrease the blood flow in the outer blood flow stream downstream of the branch vessel.

22. A method of delivering a therapeutic or diagnostic agent to a patient'"'"'s kidney, comprising:

a) providing a catheter comprising

i) an elongated shaft having at least one lumen therein in fluid communication with at least one agent delivery port in a distal section of the shaft;

ii) a tubular member on the distal section of the shaft having an interior passageway which is radially expandable within a blood vessel, and which is configured to extend within the blood vessel upstream and downstream of a branch vessel; and

iii) a radially expandable member on the tubular member, downstream of the shaft agent delivery port, having an expanded configuration with an outer diameter larger than an outer diameter of the tubular member and which is configured to decrease the blood flow in the outer blood flow stream downstream of the branch vessel; and

b) advancing a distal portion of the catheter within the patient'"'"'s descending aorta so that the agent delivery port is upstream or adjacent to at least one renal artery of the patient, and the radially expandable member is downstream of the at least one renal artery;

c) expanding the tubular member to separate blood flow through the descending aorta into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member;

d) expanding the radially expandable member to the expanded configuration to thereby decrease the blood flow in the outer blood flow stream downstream of the at least one renal artery; and

e) flowing a therapeutic or diagnostic agent from the shaft lumen to the agent delivery port and into the outer blood flow stream in the aorta, to deliver the therapeutic or diagnostic agent to the at least one renal artery.