Intra-aortic renal delivery catheter

• US 7,563,247 B2
• Filed: 08/06/2003
• Issued: 07/21/2009
• Est. Priority Date: 09/20/2002
• Status: Expired due to Fees

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Geoffrion, Richard, Maguire, Mark
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): MacNeill; Elizabeth R
• Application Number:
  US10/636,801
• Publication Number:
  US 20040059277A1
• Time in Patent Office: 2,176 Days
• Field of Search: 604/508, 604/509, 604/95.03, 604/95.05, 604/103.01, 604/103.02, 604/103.07, 604/8, 604/96.01, 604/103.14, 604104-107, 604/264, 606/200
• US Class Current: 604/104
• 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 medical device system, comprising:

a delivery shaft with a proximal end portion and a distal end portion having a longitudinal axis;

a tubular member secured to the distal end portion of the delivery shaft and having a proximal end portion, a distal end portion, and a tubular wall comprising a substantially non-porous sheet of material formed into a tubular shape with an outer surface and an inner surface that defines an interior passageway extending along the axis between a proximal open end along the proximal end portion of the tubular member and a distal open end along the distal end portion of the tubular member;

a proximal radial support member secured to the distal end portion of the delivery shaft and comprising a ring-shaped support wire also secured substantially along a circumference of the proximal end portion of the tubular member; and

a distal radial support member comprising a ring-shaped support wire secured substantially along a circumference of the distal end portion of the tubular member;

wherein the tubular member has a distally tapered shape that tapers from a proximal outer diameter along the proximal end portion to a distal outer diameter that is less than the proximal outer diameter along the distal end portion of the tubular member,

wherein the proximal radial support member is adjustable between a collapsed condition and a radially expanded condition having an expanded circumference, and the proximal end portion of the tubular member is adjustable between a collapsed condition and a radially expanded condition having an expanded circumference, such that the expanded circumference of the proximal radial support member in the radially expanded condition corresponds to the expanded circumference of the proximal end portion of the tubular member in the radially expanded condition,

wherein the distal radial support member is adjustable between a collapsed condition and a radially expanded condition having an expanded circumference, and the distal end portion of the tubular member is adjustable between a collapsed condition and a radially expanded condition having an expanded circumference, such that the expanded circumference of the distal radial support member in the radially expanded condition corresponds to the expanded circumference of the distal end portion of the tubular member in the radially expanded condition, and

wherein the expanded circumference of the proximal radial support member in the radially expanded condition is greater than the expanded circumference of the distal radial support member in the radially expanded condition.

2. The system of claim 1, wherein:

the distal radial support member is also secured to the distal end portion of the delivery shaft distally to the proximal radial support member.

3. The system of claim 1, further comprising:

a longitudinal support member extending along the axis and secured to the proximal and distal radial support members, respectively, and that is adapted to hold the respective radial support members at relatively fixed longitudinal positions relative to each other with respect to the longitudinal axis.

4. The system of claim 3, wherein:

the longitudinal support member comprises a region of the distal end portion of the delivery shaft.

5. The system of claim 3, wherein:

the longitudinal support member is the sole longitudinal support member secured to the tubular member and extends along the tubular wall of the tubular member relative to the longitudinal axis; and

the tubular member does not include other longitudinal or radial support members than the proximal and distal radial support members and the longitudinal support member.

6. The system of claim 1, wherein:

each of the ring-shaped support wires of the proximal and distal radial support members, respectively, comprises a shape-retaining material.

7. The system of claim 6, wherein:

each of the ring-shaped support wires of the proximal and distal radial support members, respectively, comprises a nickel-titanium metal alloy material.

8. The system of claim 6, wherein:

each of the ring-shaped support wires comprises an elongated wire having a length between two opposite ends;

wherein the elongated wire has an intermediate portion between the opposite ends that is ring-shaped such that the two ends are positioned closely adjacent to each other; and

wherein the two adjacently positioned ends are secured to a longitudinal support member extending between the proximal and distal radial support members.

9. The system of claim 1, wherein:

the sheet of material comprises a fluoropolymer material.

10. The system of claim 9, wherein:

the fluoropolymer material comprises a polytetrafluoroethylene (PTFE) material.

11. The system of claim 1, wherein:

the tubular member is adjustable between a radially collapsed condition and a radially expanded condition;

in the radially collapsed condition the tubular member has a respective collapsed outer diameter that is adapted to be delivered to a location within an aorta adjacent to at least one renal artery ostium in a patient with the proximal end portion of the tubular member positioned downstream from the ostium and the distal end portion of the tubular member positioned upstream from the tubular member; and

the tubular member is adjustable at the location to the radially expanded condition with a radially expanded outer diameter that is larger than the collapsed outer diameter, and such that tubular wall divides aortic flow along the location into exterior and interior blood streams that are substantially isolated from each other by the tubular wall along the location;

wherein the tubular wall in the radially expanded condition at the location directs the exterior blood stream along an exterior flow path within a circumferential area surrounding the tubular member and between the outer surface of the tubular member and the aortic wall into the renal artery ostium, and

wherein the tubular wall in the radially expanded condition at the location allows the interior blood stream to flow along an interior flow path corresponding to the interior passageway and that perfuses downstream across the location.

12. The system of claim 11, further comprising:

a fluid agent delivery assembly cooperating with the tubular member;

wherein the fluid agent delivery assembly is adapted to deliver a volume of fluid agent primarily into the exterior flow path; and

wherein the tubular member in the radially expanded condition at the location is adapted to substantially prevent fluid communication with respect to the volume of fluid agent through the tubular wall and from the exterior circumferential area and into the interior passageway.

13. The system of claim 12, wherein the fluid agent delivery assembly further comprises:

a delivery passageway extending between a proximal port located externally of the body of the patient and a distal port that is adapted to be positioned at an injection location within the blood vessel;

wherein the proximal port is adapted to couple to a source of fluid agent;

wherein the delivery passageway is adapted to deliver the volume of fluid agent from the fluid agent source and through the distal port into the injection location within the blood vessel; and

wherein the injection location is positioned to allow the volume of fluid agent to flow substantially along the exterior flow path and without substantial mixing of the fluid agent into the interior passageway of the tubular member along the location.

14. The system of claim 11, wherein:

the tubular member is adjustable between a radially collapsed condition and a radially expanded condition;

in the radially collapsed condition the tubular member has a respective collapsed outer diameter that is adapted to be delivered to a location within an aorta adjacent to at least one renal artery ostium in a patient with the proximal end portion of the tubular member positioned downstream from the ostium and the distal end portion of the tubular member positioned upstream from the tubular member; and

the tubular member is adjustable at the location to the radially expanded condition with a radially expanded outer diameter that is larger than the collapsed outer diameter, and such that tubular wall divides aortic flow along the location into first and second blood streams that are substantially isolated from each other by the tubular wall along the location;

wherein the tubular wall in the radially expanded condition at the location directs the first blood stream along an exterior flow path within the exterior circumferential area surrounding the tubular member and between the outer surface of the tubular member and the aortic wall, which exterior flow path is directed to flow primarily into the at least one renal artery ostium, and

wherein the tubular wall in the radially expanded condition at the location allows the second blood stream to flow along an interior flow path corresponding to the interior passageway and that perfuses downstream across the location.