Intra-aortic renal drug delivery catheter

• US 7,329,236 B2
• Filed: 09/07/2005
• Issued: 02/12/2008
• Est. Priority Date: 01/11/1999
• Status: Expired due to Fees

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Rosenthal, Michael H., Kramer, Andrew W., Payne, Sam G., Pesotchinsky, Sophia, Kesten, Randy J.
• Primary Examiner(s): Lucchesi; Nicholas D.
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US11/221,679
• Publication Number:
  US 20060189960A1
• Time in Patent Office: 888 Days
• Field of Search: 604/102.02, 604/102.03, 604/102.01, 604/96.01, 604/915, 604/509, 604/508, 604/93.01, 604/103.07, 604105-108, 604/103.05, 606/192
• US Class Current: 604/96.01
• 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 2025/1004 Balloons with folds, e.g. folded or multifolded
• 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 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A catheter for delivering a therapeutic or diagnostic agent to a branch blond vessel of a major blood vessel comprises 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.

Claims

1. A system for enhancing renal function in a patient, comprising:

a delivery catheter with a proximal end portion and a distal end portion with a fluid delivery port;

a flow diverter located along the distal end portion, the flow diverter comprising a tubular member that when in an expanded configuration provides an interior passageway therein, the interior passageway having a proximal opening and a distal opening, such that the proximal opening of the interior passageway is disposed proximal to the fluid delivery port and the distal opening of the interior passageway is disposed distal to the fluid delivery port;

a pull wire having a distal end that is coupled with the tubular member; and

a source of fluid agent;

wherein the tubular member is configured to expand from a low profile configuration to an expanded configuration when the pull wire is retracted proximally, such that in the expanded configuration the tubular member provides an interior passageway that extends between a proximal opening of the tubular member and a distal opening of the tubular member;

wherein the delivery catheter is adapted to couple to the source of fluid agent;

wherein the delivery catheter is adapted to position the distal end portion at a location within an abdominal aorta associated with a plurality of renal artery ostia having unique respective positions along the abdominal aorta wall;

wherein when the tubular member is in the expanded configuration so as to provide the interior passageway therein, the flow diverter at the location is adapted to divert a portion of aortic blood flow along a diverted flow path external to the tubular member and substantially only into the plurality of renal arteries via their respective ostia and to allow a second portion of aortic blood flow from the distal opening of the interior passageway downstream across the plurality of renal artery ostia to the proximal opening of the interior passageway;

wherein the fluid delivery port is positioned relative to the flow diverter so as to inject a volume of the fluid agent from the source into the diverted flow path; and

wherein the fluid agent is adapted to enhance renal function.

2. The system of claim 1, wherein the fluid agent comprises a vasoactive agent.

3. The system of claim 1, wherein the fluid agent comprises a member selected from the group consisting of Papaverine, a Calcium-channel blocker, Nifedipine, Verapamil, Fenoldapam, and a dopamine DA1 agonist.

4. The system of claim 1, wherein the tubular member comprises a conical shape or a frustroconical shape.

5. The system of claim 1, wherein the tubular member comprises an inflatable member.

6. The system of claim 1, wherein the tubular member comprises a spring force that urges the tubular body to elongate and reduce in diameter.

7. The system of claim 1, wherein the tubular member comprises braided filaments.

8. The system of claim 1, wherein the tubular member comprises an agent delivery opening that is adjacent to the fluid delivery port of the delivery catheter.

9. The system of claim 1, wherein the fluid delivery port is proximal to a distal end of the tubular member.

10. A system for enhancing renal function in a patient, comprising:

a delivery catheter with a proximal end portion and a distal end portion with a fluid delivery port;

a flow diverter located along the distal end portion, the flow diverter comprising a tubular member that when in an expanded configuration provides an interior passageway therein, the interior passageway having a proximal opening and a distal opening, such that the proximal opening of the interior passageway is disposed proximal to the fluid delivery port and the distal opening of the interior passageway is disposed distal to the fluid delivery port, the tubular member comprising a self-expanding frame;

a source of fluid agent; and

a restraining member configured to apply a compressive force to the self-expanding frame so as to hold the frame in a low profile configuration;

wherein the tubular member is configured to expand from the low profile configuration to an expanded configuration when the restraining member is removed, such that in the expanded configuration the tubular member provides an interior passageway that extends between a proximal opening of the tubular member and a distal opening of the tubular member;

wherein the delivery catheter is adapted to couple to the source of fluid agent;

wherein the delivery catheter is adapted to position the distal end portion at a location within an abdominal aorta associated with a plurality of renal artery ostia having unique respective positions along the abdominal aorta wall;

wherein when the tubular member is in the expanded configuration so as to provide the interior passageway therein, the flow diverter at the location is adapted to divert a portion of aortic blood flow along a diverted flow path external to the tubular member and substantially only into the plurality of renal arteries via their respective ostia and to allow a second portion of aortic blood flow from the distal opening of the interior passageway downstream across the plurality of renal artery ostia to the proximal opening of the interior passageway;

wherein the fluid delivery port is positioned relative to the flow diverter so as to inject a volume of the fluid agent from the source into the diverted flow path; and

wherein the fluid agent is adapted to enhance renal function.

11. The system of claim 10, wherein the frame comprises a plurality of longitudinally extending filaments joined together at proximal and distal ends thereof.

12. The system of claim 10, comprising a sheath coupled with the self-expanding frame.

13. The system of claim 10, wherein the fluid agent comprises a vasoactive agent.

14. The system of claim 10, wherein the fluid agent comprises a member selected from the group consisting of Papaverine, a Calcium-channel blocker, Nifedipine, Verapamil, Fenoldapam, and a dopamine DA1 agonist.

15. The system of claim 10, wherein the tubular member comprises a conical shape or a frustroconical shape.

16. The system of claim 10, wherein the tubular member comprises an inflatable member.

17. The system of claim 10, wherein the tubular member comprises a spring force that urges the tubular body to elongate and reduce in diameter.

18. The system of claim 10, wherein the tubular member comprises braided filaments.

19. The system of claim 10, wherein the tubular member comprises an agent delivery opening.

20. The system of claim 10, wherein the tubular member comprises an agent delivery opening that is adjacent to the fluid delivery port of the delivery catheter.

21. The system of claim 10, wherein the fluid delivery port is proximal to a distal end of the tubular member.