Catheter system and electrode assembly for intraprocedural evaluation of renal denervation

Patent metadata

Field	Value
Publication number	US-2017367756-A1
Application number	US-201715630134-A
Country	US
Kind code	A1
Filing date	Jun 22, 2017
Priority date	Jun 23, 2016
Publication date	Dec 28, 2017
Grant date	—

Abstract

The present disclosure provides catheter systems, electrode assemblies, and methods for electrically stimulating one or more points about the circumference of the renal artery to provide real time intraprocedural operational feedback to the operator of a renal denervation procedure to allow for more precise and thorough ablation of the renal artery and better patient outcomes. In many embodiments, an electrode assembly is provided that includes multiple splines that extend from an insulated proximal hub to an insulated distal hub and are interconnected to an electrical wire to allow the splines to independently function as electrical stimulation electrodes. The electrically active splines can then be energized at one or more desired points during a renal denervation procedure to provide operational feedback.

First claim

What is claimed is:

1 . A catheter system comprising:
a catheter shaft; and an electrode assembly carried by the catheter shaft and including a proximal hub, a distal hub, and a first spline extending from the proximal hub to the distal hub, wherein the first spline includes a first ablation electrode thereon; and wherein the first spline is interconnected with an electrical wire to allow the first spline to function as a stimulation electrode.

2 . The catheter system of claim 1 , wherein the first hub and the second hub are constructed from an electrically insulating material.

3 . The catheter system of claim 2 , wherein the insulating material is a high temperature liquid crystal polymer.

4 . The catheter system of claim 1 , wherein the first spline and the first ablation electrode are constructed from the same material.

5 . The catheter system of claim 4 , wherein the first spline and the first ablation electrode are constructed from a metal alloy of nickel and titanium.

6 . The catheter system of claim 1 , further comprising a second spline that includes a second ablation electrode.

7 . The catheter system of claim 6 , wherein the second spline is interconnected with an electrical wire to allow the second spline to function as a stimulation electrode.

8 . The catheter system of claim 7 , further comprising a third spline that includes a third ablation electrode and a fourth spline that includes a fourth ablation electrode.

9 . The catheter system of claim 8 , wherein the third spline and fourth spline are interconnected with an electrical wire to allow the third spline and the fourth spline to function as a stimulation electrode.

10 . The catheter system of claim 1 , wherein the electrode assembly further includes at least one thermocouple.

11 . An electrode assembly comprising:
an electrically insulating proximal hub and an electrically insulating distal hub; a first spline extending from the electrically insulating proximal hub to the electrically insulating distal hub and carrying a first ablation electrode; and a second spline extending from the electrically insulating proximal hub to the electrically insulating distal hub and carrying a second ablation electrode; wherein the first spline and the second spline are interconnected with an electrical wire to allow the first spline and the second spline to independently function as stimulation electrodes.

12 . The electrode assembly of claim 11 , further comprising:
a third spline extending from the proximal hub to the distal hub and carrying a third ablation electrode; and a fourth spline extending from the proximal hub to the distal hub and carrying a fourth ablation electrode.

13 . The electrode assembly of claim 12 , wherein the third spline and the fourth spline are interconnected with an electrical wire to allow the third spline and the fourth spline to independently function as stimulation electrodes.

14 . A method of evaluating the intraprocedural success of a renal denervation procedure on a subject, the method comprising:
electrically stimulating multiple points about the circumference of a renal artery of the subject using at least one spline of an electrode assembly as a stimulation electrode to determine a baseline physiological response of the subject; performing a renal denervation procedure on the renal artery of the subject; electrically stimulating the multiple points about the circumference of the renal artery of the subject using at least one spline of an electrode assembly as a stimulation electrode to determine the physiological response of the subject; and comparing the baseline physiological response of the subject prior to renal denervation with the physiological response after renal denervation.

15 . The method of claim 14 wherein the electrical stimulation of the renal artery and the renal denervation are performed using the same electrode assembly.

16 . The method of claim 14 wherein the electrode assembly comprises at least four electrically active splines and at least four ablation electrodes

17 . The method of claim 14 wherein the electrical stimulation is performed using sequential electrical stimulation.

18 . The method of claim 14 wherein the electrical stimulation is performed using simultaneous electrical stimulation.

19 . The method of claim 14 wherein the electrical stimulation is bipolar electrical stimulation.

20 . The method of claim 14 wherein the electrical stimulation provides current in an amount of from about 0.1 milliamps to about 40 milliamps at a frequency of from about 1 Hertz to about 50 Hertz for a time period of from about 1 millisecond to about 5 milliseconds.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Sliwa John
• Morse Stephen A
• Hata Cary

Classifications

• A61B2018/1467

  using more than two electrodes on a single probe · CPC title

• A61B5/0215

  by means inserted into the body · CPC title

• A61B18/1492 Primary

  having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence) · CPC title

• A61B2018/00988

  Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter · CPC title

• A61B2018/00642

  with feedback, i.e. closed loop control · CPC title