Feedback systems and methods for renal denervation utilizing balloon catheter

• US 9,427,283 B2
• Filed: 03/08/2016
• Issued: 08/30/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Nabutovsky, Yelena, Karst, Edward, Qu, Fujian
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US15/063,600
• Publication Number:
  US 20160184010A1
• Time in Patent Office: 175 Days
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 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 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00744 Fluid flow
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00773 Sensed parameters
• CPC Class Codes: A61B 2018/00863 Fluid flow
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/6853 with a balloon

Abstract

A renal denervation system includes an ablation catheter and an inflation balloon. The renal denervation catheter is insertable into a renal artery to perform a renal denervation procedure. The inflation balloon is inflatable within the renal artery, wherein one of a blood pressure condition in the renal artery resulting from operation of the inflation balloon and a performance characteristic of the inflation balloon indicates efficacy of the renal denervation procedure.

Claims

1. A method of determining efficacy of a renal denervation procedure in a renal artery, comprising:

providing a renal denervation catheter and an inflation balloon;

measuring a first amount of time to fill the inflation balloon within the renal artery;

deflating the inflation balloon;

performing a first renal denervation procedure in the renal artery with the renal denervation catheter;

after performing the renal denervation procedure, measuring a second amount of time to fill the inflation balloon within the renal artery;

comparing the first and second amounts of time to determine efficacy of the first renal denervation procedure.

2. The method of claim 1, wherein measuring the first amount of time to fill the inflation balloon includes measuring the first amount of time to fill the inflation balloon to a predetermined pressure level.

3. The method of claim 1, further comprising axially moving the renal denervation catheter within the renal artery, performing a second renal denervation procedure, after performing the second renal denervation procedure, measuring a third amount of time to fill the inflation balloon, and comparing the third amount of time with at least one of the first and second amounts of time to determine efficacy of the second renal denervation procedure.

4. The method of claim 1, further comprising positioning a balloon sensor in the inflation balloon, wherein measuring the first amount of time comprises measuring the first amount of time using the balloon sensor, and wherein measuring the second amount of time comprises measuring the second amount of time using the balloon sensor.

5. The method of claim 1, wherein a difference between the first amount of time and the second amount of time correlates to unloading of sympathetic tone from the renal artery.

6. The method of claim 1, wherein measuring the first amount of time to fill the inflation balloon includes measuring the first amount of time to fill the inflation balloon to a predetermined size.

7. A method of determining efficacy of a renal denervation procedure in a renal artery, comprising:

providing a renal denervation catheter and an inflation balloon;

inflating the inflation balloon to block blood flow through the renal artery and measuring a first rate of decay of blood pressure in the renal artery;

deflating the inflation balloon;

performing a first renal denervation procedure in the renal artery with the renal denervation catheter;

after performing the renal denervation procedure, inflating the inflation balloon to block blood flow through the renal artery and measuring a second rate of decay of blood pressure in the renal artery;

comparing the first and second rates of decay of blood pressure to determine efficacy of the first renal denervation procedure.

8. The method of claim 7, wherein the renal denervation catheter includes a plurality of ablation members, the method comprising positioning the inflation balloon distal of the plurality of ablation members prior to filling the inflation balloon.

9. The method of claim 7, further comprising providing the renal denervation catheter and inflation balloon on a common delivery device.

10. The method of claim 7, further comprising performing a second renal denervation procedure after comparing the rates of decay of blood pressure, after performing the second renal denervation procedure, filling the inflation balloon to block blood flow through the renal artery and measuring a third rate of decay of blood pressure in the renal artery, and comparing the third rate of decay of blood pressure with at least one of the first and second rates of decay of blood pressure to determine efficacy of the second renal denervation procedure.

11. The method of claim 7, wherein measuring the first rate of decay of blood pressure in the renal artery includes positioning a pressure sensor in the renal artery distal of the inflation balloon.

12. The method of claim 11, wherein positioning the pressure sensor includes positioning the pressure sensor on a distal end of the renal denervation catheter.

13. The method of claim 11, wherein positioning the pressure sensor includes positioning the pressure sensor on a deployable basket used to perform the first renal denervation procedure.

14. The method of claim 7, wherein measuring the first rate of decay of blood pressure includes measuring a time it takes to complete a predetermined percentage of a transition between a mean arterial pressure and a central venous pressure.

15. The method of claim 14, wherein the predetermined percentage is in the range of about 50% to about 75%.