Intra-aortic renal delivery catheter

• US 7,241,273 B2
• Filed: 08/06/2003
• Issued: 07/10/2007
• Est. Priority Date: 09/20/2002
• Status: Expired due to Fees

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Geoffrion, Richard, Maguire, Mark
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): MacNeill; Elizabeth R.
• Application Number:
  US10/636,359
• Publication Number:
  US 20040059179A1
• Time in Patent Office: 1,434 Days
• Field of Search: 604/27, 604/28, 604/6.16, 604/500, 604/48
• US Class Current: 604/6.16
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 2025/1095 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 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/127 Aorta
• 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

Abstract

A renal flow system and method direct fluid into renal arteries from a location within the aorta. A renal flow assembly has a tapered tube that is adjustable between a radially collapsed condition for delivery to the location through a delivery sheath and a radially expanded condition that divides aortic flow into exterior and interior paths. The tube'"'"'s wall is made from a sheet of flexible material, such as PTFE or ePTFE. Two, nickel-titanium rings radially support the tube'"'"'s ends and are connected by a longitudinal spine support. A fluid delivery assembly injects drug to flow along the exterior flow path and the tubular wall directs the agent into the renal artery ostium. The tube'"'"'s taper has localized shape for circumferential agent mixing to infuse both kidneys'"'"' renals. The flow assembly allows an interventional device, e.g. delivery catheter, to advance across the location while directing blood into the renals and perfusing downstream circulation. The renal flow assembly and distal device are used within a common guide sheath through a single puncture wound. Vasodilators, antioxidants, or diuretics are delivered to the kidneys to treat/prevent RCN, CHF, or ARF.

Claims

1. A method for providing localized medical care to a renal system in a patient, comprising:

positioning a distal end portion of a catheter at a location within the patient'"'"'s aorta that is adjacent to an ostium of at least one renal artery extending from the aorta;

using the distal end portion of the catheter from within the aorta at the location, directing a volume of fluid within the aorta to be locally delivered primarily into the at least one renal artery via its ostium;

while locally delivering the volume of fluid into the at least one renal artery, allowing a substantial volume of aortic blood to flow downstream past the location and into the patient'"'"'s downstream circulation downstream from the renal artery ostium;

substantially isolating the volume of fluid being directed into the at least one renal artery from mixing with the substantial volume of aortic blood flowing downstream from the location; and

conducting an interventional medical procedure at least in part with a guide or diagnostic catheter at an upstream location upstream from the location while locally directing the volume of fluid into the at least one renal artery, and while allowing the substantial volume of aortic blood to flow downstream from the ostium, and also while substantially isolating the volume of fluid from mixing with the substantial volume of aortic blood flowing downstream.

2. The method of claim 1, wherein the volume of fluid comprises an outer blood flow component of aortic blood, and further comprising:

passively directing the outer blood flow component into the at least one renal artery at an increased pressure at the respective ostium that is artificially elevated by the catheter to be greater than a normal physiologic pressure at the ostium for that patient.

3. The method of claim 1, further comprising:

preventing a portion of the aortic blood from passively flowing downstream across the location and past the renal artery ostium; and

passively redirecting the portion of aortic blood toward the at least one renal artery ostium using the distal end portion of the catheter.

4. The method of claim 1, wherein the volume of fluid comprises a fluid agent, and further comprising:

providing a proximal port at the proximal end portion of the catheter in fluid communication with a source of the fluid agent externally of the patient while the distal end portion of the catheter is positioned at the location;

delivering a volume of the fluid agent through the catheter to the location within the aorta; and

directing the volume of fluid agent to flow from the location within the aorta and principally into the at least one renal artery via its ostium.

5. The method of claim 1, wherein the interventional medical procedure further comprises:

injecting a radiopaque contrast agent into the patient'"'"'s arterial system at a location that is upstream from the renal ostium.

6. The method of claim 5, further comprising:

providing the volume of fluid being directed into the renal artery with an agent that is adapted to treat or protect the patient'"'"'s renal system with respect to the radiopaque contrast agent being injected at the upstream location.

7. The method of claim 1, further comprising:

providing the volume of fluid being locally directed into the least one renal artery with an agent that comprises at least one of a vasodilator, an antioxidants, or a diuretic.

8. The method of claim 1, wherein the interventional medical procedure further comprises:

positioning a delivery device at least in part within the patient'"'"'s aorta at an upstream location that is upstream from the renal artery ostium.

9. The method of claim 8, wherein the delivery device comprises an angiographic catheter.

10. The method of claim 8, wherein the delivery device comprises a guiding catheter.

11. The method of claim 8, wherein:

the delivery device is positioned at least in part within a coronary artery ostium.

12. The method of claim 8, wherein:

the delivery device is positioned at least in part within a carotid artery ostium.

13. The method of claim 1, further comprising:

locally directing the volume of fluid into multiple renal arteries via multiple respective ostia that are located at unique, relatively spaced positions along the aorta, and wherein each kidney is perfused by at least a respective one of the multiple renal arteries.

14. The method of claim 13, wherein the volume of fluid comprises a fluid agent, and further comprising:

mixing the volume of fluid agent in an outer, circumferential region of the aortic blood flowing along the location adjacent the wall of the aorta and while substantially isolating the volume of agent from mixing with an inner region of aortic blood flowing downstream past the location and that is substantially surrounded by the outer, circumferential region; and

directing the aortic blood and mixed agent in the outer, circumferential region to principally flow into the multiple renal arteries via their respective ostia.

15. The method of claim 14, further comprising:

positioning a tubular member with a distal end portion of the tubular member located upstream from the location of the ostia and a proximal end portion of the tubular member located downstream from the location;

with the proximal and distal end portions at the downstream and upstream locations, respectively, providing the tubular member with a distally reducing tapered shape such that the proximal end portion has a first outer diameter that is sufficient to substantially circumferentially engage the aorta wall at the downstream location, and further such that the distal end portion has a second outer diameter that is sufficiently less than the inner diameter of the aorta wall at the upstream location; and

wherein the outer, circumferential region of aortic blood is located between an outer surface of the tubular member and the aortic wall between the distal tip of the distal end portion and the ostia.

16. The method of claim 15, further comprising:

delivering the volume of fluid agent into the outer, circumferential region of blood flow at a first isolated radial position; and

providing the shape of the tubular member with a mixing region having a different taper than other regions of the tubular member and that is associated with the first isolated circumferential position;

wherein the mixing region is adapted to enhance the mixing of the agent with blood circumferentially around the tubular member to thereby more evenly distribute the agent to renal arteries having respective ostia at respectively unique circumferential locations around the aorta at the location.

17. The method of claim 1, wherein the volume of aortic blood is allowed to flow passively downstream across the location during the delivery of the agent into the at least one renal artery.

18. A method as in claim 1, further comprising:

locally delivering at least one of a vasodilator, antioxidant, or diuretic agent substantially into a renal artery from the location within the aorta.

19. The method of claim 18, further comprising locally delivering a vasodilator into the at least one renal artery.

20. The method of claim 19, further comprising locally delivering at least one of papavarine, fenoldopam, calcium channel blockers, atrial natriuretic peptide (ANP), acetylcholine, nifedipine, nitroglycerine, nitroprusside, adenosine, dopamine, or theophylline, or combinations or blends thereof, into the at least one renal artery.

21. The method of claim 18, further comprising locally delivering an antioxidant into the at least one renal artery.

22. The method of claim 21, further comprising delivering acetylcysteine into the at least one renal artery.

23. The method of claim 18, further comprising delivering a diuretic agent into the at least one renal artery ostium.

24. The method of claim 23, further comprising delivering at least one of mannitol, or furosemide, or combinations or blends thereof, into the at least one renal artery.

25. A method for directing fluid to a renal system in a patient, comprising:

positioning a renal device at a location within the patient'"'"'s aorta that is adjacent to an ostium of at least one renal artery extending from the aorta;

dividing a first portion of aortic flow and a second portion of aortic flow from an aortic blood flow within the aorta with the renal device;

directing the first portion of aortic blood flow into the at least one renal artery, while allowing the second portion to flow across the location and downstream of the ostium;

locally delivering a volume of fluid comprising a diagnostic, prophylactic or therapeutic agent the to at least one renal artery in the patient with the renal device; and

while locally delivering the volume of fluid to the at least one renal artery with the renal device, positioning a medical device within an aorta of the patient upstream from an ostium of the at least one renal artery along the aorta of the patient.

26. A method as claim 25, further comprising:

locally delivering at least one of a vasodilator, antioxidant, or diuretic agent substantially into a renal artery from the location within the aorta.

27. The method of claim 26, further comprising locally delivering a vasodilator into the at least one renal artery.

28. The method of claim 27, further comprising locally delivering at least one of paparavine, fenoldopam, calcium channel blockers, atrial natriuretic peptide (ANP), acetylcholine, nifedipine, nitroglycerine, nitroprusside, adenosine, dopamine, or theophylline, or combinations or blends thereof, into the at least one renal artery.

29. The method of claim 27, further comprising locally delivering an antioxidant into the at least one renal artery.

30. The method of claim 29, further comprising delivering acetylcysteine into the at least one renal artery.

31. The method of claim 26, further comprising delivering a diuretic agent into the at least one renal artery.

32. The method of claim 26, further comprising delivering at least one of mannitol, or furosemide, or combinations or blends thereof, into the at least one renal artery.