Renal infusion systems and methods

• US 7,993,325 B2
• Filed: 09/29/2005
• Issued: 08/09/2011
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Patel, Samir R, Ball, Craig A, Hekmat, Neema, Goodson, Harry B IV, Valencia, Aurelio, Elkins, Jeffrey M.
• Primary Examiner(s): Stigell; Theodore
• Assistant Examiner(s): Bosworth; Kami A
• Application Number:
  US11/241,749
• Publication Number:
  US 20060079859A1
• Time in Patent Office: 2,140 Days
• Field of Search: 604/101.01, 604/101.03, 604/101.05, 604/102.01, 604 43- 45, 604/258, 604/276, 604/508, 604/510, 604/523, 604/284
• US Class Current: 604/508
• 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 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• 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 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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

Systems, devices, and methods for delivering treatment to the renal arteries are provided. Exemplary systems include a delivery catheter having a distal bifurcation, an introducer assembly comprising an introducer sheath in operative association with a Y-hub, wherein Y-hub includes a first port for receiving the delivery catheter and a second port for receiving a second catheter, and a constraint assembly for holding the distal bifurcation of the delivery catheter in a low-profile configuration when it is advanced distally beyond the introducer sheath.

Claims

1. A method for positioning a delivery catheter in the renal arteries, the method comprising:

positioning an introducer sheath in an iliac artery;

advancing a renal delivery catheter having a distal bifurcation through the introducer sheath;

constraining the distal bifurcation in a low-profile configuration with a constraint assembly while advancing the distal bifurcation and the constraint assembly through the introducer sheath;

advancing the constrained distal bifurcation and the constraint assembly from the introducer sheath toward the renal arteries while the bifurcation remains constrained by the constraint assembly, such that the distal bifurcation and the constraint assembly move relative to the introducer sheath;

releasing the distal bifurcation from the constrained low-profile configuration to allow entry of a first distal extension of the distal bifurcation into one of the renal arteries and a second distal extension of the distal bifurcation into the other renal artery, wherein the first distal extension comprises a first lumen and a first distal aperture, and the second distal extension comprises a second lumen and a second distal aperture; and

delivering a fluid agent through the first and second distal extension lumens and the first and second distal apertures, respectively, such that the fluid agent flows into blood flowing within the renal arteries and feeds downstream into the kidneys via the renal arteries.

2. The method of claim 1, wherein the constraint assembly comprises a sheath, and constraining the distal bifurcation in the low-profile configuration comprises constraining the distal bifurcation with the sheath.

3. The method of claim 2, wherein passing the constrained distal bifurcation from the introducer sheath toward the renal arteries comprises advancing the sheath over a guide wire.

4. The method of claim 1, wherein the constraint assembly comprises a ring capture system, and constraining the distal bifurcation in the low-profile configuration comprises constraining the distal bifurcation with the ring capture system.

5. The method of claim 4, wherein passing the constrained distal bifurcation from the introducer sheath toward the renal arteries comprises advancing the ring capture system along a guide wire.

6. The method of claim 1, wherein the constraint assembly comprises a guide wire ring, and constraining the distal bifurcation in the low-profile configuration comprises constraining the distal bifurcation with the guide wire ring.

7. The method of claim 6, wherein passing the constrained distal bifurcation from the introducer sheath toward the renal arteries comprises advancing the guide wire ring along a guidewire.

8. The method of claim 1, further comprising advancing a second catheter through the introducer sheath.

9. The method of claim 8, further comprising performing a diagnostic or interventional procedure with the second catheter.

10. A method of positioning a delivery catheter in a first branch lumen and a second branch lumen, each branch lumen extending from a main lumen in a body of a patient, the method comprising:

positioning an introducer sheath in the main lumen;

advancing a delivery catheter having a distal bifurcation through the introducer sheath, wherein the distal bifurcation comprises a first distal extension having a first lumen and a first distal aperture, and a second distal extension having a second lumen and a second distal aperture;

constraining the distal bifurcation in a low-profile configuration while advancing the distal bifurcation through the introducer sheath;

advancing the constrained distal bifurcation from the introducer sheath toward the first branch lumen and the second branch lumen; and

releasing the distal bifurcation from the constrained low-profile configuration to allow entry of the first distal extension of the distal bifurcation into the first branch lumen and entry of the second distal extension of the distal bifurcation into the second branch lumen, while allowing blood flow within the patient from an upstream location in the main lumen, past each of the first and second branch lumens, to a downstream location in the main lumen;

wherein advancing the constrained distal bifurcation comprises advancing the introducer sheath through a puncture in a first femoral artery of the patient, and further comprises advancing a guide catheter through the introducer sheath and into a second femoral artery of the patient via the aortic bifurcation.

11. The method of claim 10, wherein constraining the distal bifurcation is performed using a constraint assembly comprising a member selected from the group consisting of a sheath, a ring capture system, and a guide wire ring.