Feedback systems and methods for renal denervation utilizing balloon catheter

• US 9,713,494 B2
• Filed: 07/26/2016
• Issued: 07/25/2017
• 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:
  US15/219,991
• Publication Number:
  US 20160331451A1
• Time in Patent Office: 364 Days
• 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 a change in the first and second amounts of time; and

determining that the efficacy of the first renal denervation procedure is sufficient when the change in the first and second amounts of time is within a predetermined range.

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:

determining that the efficacy of the first renal denervation procedure is insufficient when the change in the first and second amounts of time is not within the predetermined range;

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 3, wherein comparing the third amount of time with at least one of the first and second amounts of time comprises comparing the first and third amounts of time to determine a change in the first and third amounts of time, the method further comprising determining that the efficacy of the second renal denervation procedure is sufficient when the change in the first and third amounts of time is within the predetermined range.

5. The method of claim 3, wherein comparing the third amount of time with at least one of the first and second amounts of time comprises comparing the second and third amounts of time to determine a change in the second and third amounts of time, the method further comprising determining that the efficacy of the second renal denervation procedure is sufficient when the change in the second and third amounts of time is within another predetermined range.

6. 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.

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

8. 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.

9. The method of claim 1 further comprising removing the renal denervation catheter and the inflation balloon from the renal artery after determining that the efficacy of the first renal denervation procedure is sufficient.

10. The method of claim 1 further comprising providing the renal denervation catheter and inflation balloon on a common delivery device.

11. A renal denervation system, comprising:

an ablation catheter insertable into a renal artery to perform a renal denervation procedure including ablating a renal artery;

an inflation balloon inflatable within the renal artery, wherein a performance characteristic of the inflation balloon indicates efficacy of the renal denervation procedure, wherein the performance characteristic of the inflation balloon includes an amount of time to fill the inflation balloon; and

a balloon sensor within the inflation balloon, the balloon sensor configured to measure a first amount of time to fill the inflation balloon before ablating the renal artery and a second amount of time to fill the inflation balloon after ablating the renal artery to detect a change in the first and second amounts of time.

12. The renal denervation system of claim 11, wherein the first amount of time to fill the inflation balloon includes the first amount of time to fill the inflation balloon to a predetermined pressure level.

13. The renal denervation system of claim 11, wherein the change between the first amount of time and the second amount of time correlates to unloading of sympathetic tone from the renal artery.

14. The renal denervation system of claim 11, wherein the first amount of time to fill the inflation balloon includes the first amount of time to fill the inflation balloon to a predetermined size.

15. The renal denervation system of claim 11, wherein the renal denervation catheter and the inflation balloon are coupled to a common delivery device.

16. An inflation balloon configured to be inflated within a renal artery as part of a renal denervation procedure including ablating the renal artery, wherein a performance characteristic of the inflation balloon indicates efficacy of the renal denervation procedure, wherein the performance characteristic of the inflation balloon includes an amount of time to fill the inflation balloon, the inflation balloon comprising a balloon sensor, the balloon sensor configured to measure a first amount of time to fill the inflation balloon before ablating the renal artery and a second amount of time to fill the inflation balloon after ablating the renal artery to detect a change in the first and second amounts of time.

17. The inflation balloon of claim 16, wherein the first amount of time to fill the inflation balloon includes the first amount of time to fill the inflation balloon to a predetermined pressure level.

18. The inflation balloon of claim 16, wherein the first amount of time to fill the inflation balloon includes the first amount of time to fill the inflation balloon to a predetermined size.