Intra-aortic renal delivery catheter

• US 7,063,679 B2
• Filed: 09/20/2002
• Issued: 06/20/2006
• 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): KENNEDY, SHARON E
• Application Number:
  US10/251,915
• Publication Number:
  US 20040059276A1
• Time in Patent Office: 1,369 Days
• Field of Search: 606/200, 606/191, 606/159, 604/6, 604/14, 604/104, 604/103.11, 604/96.01, 604/264, 604/509, 604/528, 604/533, 604/195, 604/6.16, 600/16, 600/29
• 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 renal flow system comprising:

a guide sheath having a proximal coupler with at least two ports, said sheath being positionable in an aorta with distal end beneath the renal arteries branching from the aorta; and

a renal flow device positionable through one of the ports of the proximal coupler, said renal flow device having a renal flow assembly near its distal end said renal flow assembly having a collapsed configuration when in the guide sheath and a radially expanded configuration when outside of the guide sheath, which the renal flow assembly has a shape which will divert a portion of aortic flow into the renal arteries while allowing a remaining portion of flow past the renal flow assembly.

2. A renal flow system as in claim 1, wherein the guide sheath comprises a tubular body having a single lumen extending distally from the proximal coupler.

3. A renal flow system as in claim 2, wherein the lumen of the tubular body of the guide sheath has a diameter from 6 French to 12 French.

4. A renal flow system as in claim 3, wherein the tubular body has a length in the range from 40 cm to 80 cm.

5. A renal flow system as in claim 1, wherein the renal flow assembly comprises an expandable tubular member with a conical surface which tapers radially inwardly in the distal direction and has an open central passageway that allows blood flow therethrough.

6. A renal flow system as in claim 1, further comprising a delivery catheter which is positionable through another of the ports of the proximal coupler.

7. A renal flow system as in claim 6, wherein the delivery catheter comprises a coronary guide catheter having a distal end configured to access a coronary artery when the guide catheter is positioned in the aorta.

8. A renal flow system comprising:

an guide sheath comprising a proximal coupler, wherein the proximal coupler comprises a first port and second port;

a renal flow device slidably engaged within the guide sheath and the first port, the renal flow device comprising a renal flow assembly; and

a delivery catheter slidably engaged within the guide sheath and the second port, the delivery catheter extending through an open central passageway of the renal flow assembly;

wherein the renal flow system has a first configuration in which the renal flow assembly is collapsed and disposed within the guide sheath, and a second configuration in which the renal flow assembly is radially expanded and disposed outside of the guide sheath, the radially expanded renal flow assembly comprising a shape which will divert a first portion of aortic flow in a radially outward direction toward a circumference of the expanded renal flow assembly while allowing a second portion of aortic flow to pass through the open central passageway of the renal flow assembly.

9. A renal flow system as in claim 8, wherein the renal flow assembly comprises:

a tubular member defined at least in part by a plurality of inflatable chambers; and

a radially expandable member coupled with an outer surface of the tubular member.

10. A renal flow system as in claim 9, wherein each inflatable chamber is joined with an adjacent chamber along a length thereof.

11. A renal flow system as in claim 9, wherein the radially expandable member inflates at a first pressure and the plurality of inflatable chambers inflate at a second pressure, the first pressure being lower that the second pressure.

12. A renal flow system as in claim 9, wherein the renal flow device comprises a catheter shaft comprising:

a first inflation lumen in fluid communication with the radially expandable member; and

a second inflation lumen in communication with the plurality of inflatable chambers.

13. A renal flow system as in claim 12, wherein the catheter shaft further comprises an agent delivery lumen in fluid communication with an agent delivery port.

14. A renal flow system comprising:

an guide sheath comprising a proximal coupler, wherein the proximal coupler comprises a first port and a second port; and

a renal flow device slidably engaged within the guide sheath and the first port, the renal flow device comprising a renal flow assembly, the renal flow system having a first configuration in which the renal flow assembly is collapsed and disposed within the guide sheath, and a second configuration in with the renal flow assembly is radially expanded and disposed outside of the guide sheath;

wherein the renal flow assembly comprises a tubular member and a radially expandable member coupled with an outer surface of the tubular member, the tubular member comprising a plurality of inflatable chamber, and wherein the renal flow device includes a catheter shaft comprising a first inflation lumen in fluid communication with the radially expandable member, a second inflation lumen in fluid communication with the plurality of inflatable chambers, and an agent delivery lumen in fluid communication with an agent delivery port, the agent delivery port providing a passageway from the agent delivery lumen to an exterior of the tubular member.

15. A renal flow system as in claim 14, further comprising a delivery catheter slidably engaged within the aortic guide sheath and the second port, the delivery catheter extending through an open central passageway of the renal flow assembly.

16. A renal flow system as in claim 14, wherein a lumen of guide sheath has a diameter from 6 French to 12 French.

17. A renal flow system as in claim 14, wherein the guide sheath has a length in the range from 40 cm to 80 cm.

18. A renal flow system as in claim 14, wherein the radially expanded renal flow assembly comprises a tapered flow surface such that a proximal transverse cross section defined by the flow surface is greater than a distal transverse cross section defined by the flow surface.