Renal denervation catheter with RF electrode and integral contrast dye injection arrangement

• US 9,089,350 B2
• Filed: 11/09/2011
• Issued: 07/28/2015
• Est. Priority Date: 11/16/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Willard, Martin R.
• Primary Examiner(s): EVOY, NICHOLAS LANE
• Application Number:
  US13/292,694
• Publication Number:
  US 20120123258A1
• Time in Patent Office: 1,357 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00571 for achieving a particular surgical effect
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A catheter includes a flexible braided shaft having a length sufficient to access a target vessel of the body, such as a renal artery. An electrode at the catheter'"'"'s distal tip is configured to ablate extravascular target tissue, such as perivascular renal nerve tissue. An electrical conductor coupled to the electrode extends along a first lumen of the shaft. A second lumen of the shaft terminates at a port arrangement on an outer surface of the shaft near the electrode. The second lumen transports a contrast media from the catheter'"'"'s proximal end and through the port arrangement. The catheter may include a steering arrangement and a lubricious coating on an outer surface of the shaft, allowing a clinician to navigate the catheter through vasculature and into the target vessel without use of a separate delivery sheath or guiding catheter.

Claims

1. An apparatus, comprising:

a catheter comprising a flexible braided shaft having a proximal end, a distal end, a length, and a lumen arrangement including first and second lumens extending between the proximal and distal ends, the length of the braided shaft sufficient to access a renal artery of a patient relative to a percutaneous access location;

an electrode provided at a distal tip of the catheter and configured to deliver electrical energy sufficient to ablate perivascular renal nerve tissue from within the renal artery;

wherein the electrode includes a central void in fluid communication with the second lumen; and

an electrical conductor coupled to the electrode and extending along the first lumen;

the second lumen terminating at one or more ports at an outer surface of the braided shaft proximate the electrode, the second lumen configured to transport a contrast media from the proximal end of the catheter and through the one or more ports.

2. The apparatus of claim 1, comprising a lubricious coating on an outer surface of the braided shaft.

3. The apparatus of claim 2, wherein the distal end of the flexible braided shaft comprises a grip segment devoid of the lubricious coating.

4. The apparatus of claim 2, comprising one or more bending control wires connected at the distal end of the flexible braided shaft and extending along the flexible braided shaft to the proximal end of the catheter, the distal end of the catheter configured for single or multiple axis deflection to facilitate advancement of the catheter'"'"'s distal end through the patient'"'"'s vasculature and into the patient'"'"'s renal artery using the one or more bending control wires and without use of a separate delivery sheath or guiding catheter.

5. The apparatus of claim 1, comprising one or more bending control wires connected at the distal end of the flexible braided shaft and extending along the first lumen to the proximal end of the catheter.

6. The apparatus of claim 1, wherein the distal end of the catheter comprises a pre-formed curve configured to facilitate steering of the catheter'"'"'s distal end through vasculature of the patient.

7. The apparatus of claim 1, where a braid of the flexible braided shaft is configured to provide one or more of enhanced mechanical support, support for one or more hemostatic valves, support for one or more radiopaque markings, support for one or more temperature sensors, and support for one or more orientation or alignment indicators.

8. The apparatus of claim 1, wherein the one or more ports comprise one or more side holes provided in a wall of the second lumen.

9. The apparatus of claim 1, wherein:

the lumen arrangement comprises a guidewire lumen dimensioned to receive a guidewire; and

the guidewire can pass and extend beyond a distal tip of the catheter through the central void of the electrode.

10. The apparatus of claim 9, wherein the second lumen defines the guidewire lumen.

11. The apparatus of claim 1, wherein:

the electrode comprises a void through with a guidewire can pass and extend beyond a distal tip of the catheter; and

a distal end of the second lumen comprises an access port dimensioned to receive the guidewire, the access port comprising a movable flap that opens for guidewire passage and closes to seal the access port for contrast media injection into the second lumen.

12. The apparatus of claim 1, wherein the electrode comprises a tip having one of a round shape, a tapered shape, and an ellipsoid shape, or comprises a combination of tapered and rounded regions.

13. The apparatus of claim 1, wherein the second lumen is further configured to receive a biocompatible thermal transfer fluid.