Devices, systems and methods for evaluation and feedback of neuromodulation treatment

• US 9,750,560 B2
• Filed: 04/22/2016
• Issued: 09/05/2017
• Est. Priority Date: 10/25/2010
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Ballakur, Sowmya, Beetel, Robert J., Friedrichs, Paul, Herzfeld, David, Wu, Andrew, Zarins, Denise, Leung, Mark S.
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US15/136,109
• Publication Number:
  US 20170020597A1
• Time in Patent Office: 501 Days
• CPC Class Codes: A61B 18/10 Power sources therefor
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2017/00075 Motion
• 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 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00672 lower
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00863 Fluid flow
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61F 2007/0093 : programmed
• CPC Class Codes: A61F 2007/126 : for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 : Devices for heating or cooling internal body cavities

Abstract

The present disclosure relates to devices, systems and methods for evaluating the success of a treatment applied to tissue in a patient, such as a radio frequency ablative treatment used to neuromodulate nerves associated with the renal artery. A system monitors parameters or values generated during the course of a treatment. Feedback provided to an operator is based on the monitored values and relates to an assessment of the likelihood that a completed treatment was technically successful. In other embodiments, parameters or values generated during the course of an incomplete treatment (such as due to high temperature or high impedance conditions) may be evaluated to provide additional instructions or feedback to an operator.

Claims

1. A method for neuromodulation treatment of a human patient, the method comprising:

delivering energy over a first period of time, via an electrode positioned at a treatment site within a blood vessel of the patient, to target neural fibers adjacent a wall of the blood vessel;

maintaining energy delivery at a first predetermined power level for a second period of time;

increasing energy delivery to a second predetermined power level if a temperature value sensed in or near the electrode is less than a preset threshold temperature following the second period of time;

obtaining a set of treatment data corresponding to a completed neuromodulation treatment;

evaluating the set of treatment data in view of one or more criteria to determine if a valuation of the completed neuromodulation treatment is within a pre-determined range; and

providing an indication as to whether the valuation of the completed neuromodulation treatment is within the pre-determined range.

2. The method of claim 1 wherein delivering energy over a first period of time, via the electrode, to target neural fibers comprises increasing energy delivery at a generally constant rate to the first predetermined first power level over the first period of time.

3. The method of claim 1 wherein obtaining the set of treatment data comprises obtaining a first set of treatment data corresponding to a first completed neuromodulation treatment, and wherein the method further comprises:

modifying the first predetermined power level, the first period of time, the second period of time, and/or the second predetermined power level based, at least in part, on the evaluation of the first treatment data and the indication as to whether the valuation of the first completed neuromodulation treatment is within the pre-determined range;

performing a second neuromodulation treatment using the modified first predetermined power level, modified first period of time, modified second period of time, and/or modified second predetermined power level; and

obtaining a second set of treatment data corresponding to a second completed neuromodulation treatment.

4. The method of claim 1 wherein providing an indication comprises displaying a message on a display screen of an energy generator used to administer the neuromodulation treatment.

5. The method of claim 4 wherein providing an indication as to whether the completed neuromodulation treatment was within the pre-determined range comprises:

displaying a first message on the display screen if the valuation of the neuromodulation treatment is within the pre-determined range; and

displaying a second, different message on the display screen if the valuation of the neuromodulation treatment indicated that treatment did not proceed as expected.

6. The method of claim 1 wherein the preset threshold temperature is from about 45 degrees Celsius to about 90 degrees Celsius.

7. The method of claim 1 wherein the preset threshold temperature is from about 60 degrees Celsius to about 75 degrees Celsius.

8. The method of claim 1 wherein the preset threshold temperature is about 65 degrees Celsius.

9. The method of claim 1 wherein the first predetermined power level is about 5 watts.

10. The method of claim 1 wherein the first period of time is about 15 seconds.

11. The method of claim 1 wherein the second period of time is at least 3 seconds.

12. The method of claim 1 the second predetermined power level is about 6 watts.

13. The method of claim 1 wherein the second predetermined power level is about 8 watts.

14. The method of claim 1 wherein the blood vessel comprises a renal artery of the patient.

15. The method of claim 1 wherein obtaining a set of treatment data corresponding to a completed treatment comprises obtaining the treatment data, at least in part, via the electrode.

16. The method of claim 1 wherein obtaining a set of treatment data comprises measuring one or more of the following:

temperature in or near the electrode, time, electrode impedance, power delivered to the electrode, blood flow in the blood vessel, blood flow velocity in the blood vessel, volumetric blood flow rate in the blood vessel, blood pressure, or heart rate of the patient.

17. The method of claim 1 wherein obtaining a set of treatment data comprises taking measurements related to one or more of the following:

a change in temperature in or near the electrode over a specified time, a maximum temperature in or near the electrode, a maximum average temperature in or near the electrode, a minimum temperature in or near the electrode, a temperature in or near the electrode at a predetermined or calculated time relative to a predetermined or calculated temperature, an average temperature in or near the electrode over a specified time, a maximum blood flow in the blood vessel, a minimum blood flow in the blood vessel, a blood flow in the blood vessel at a predetermined or calculated time relative to a predetermined or calculated blood flow, an average blood flow in the blood vessel over time, a maximum electrode impedance, a minimum electrode impedance, an electrode impedance at a predetermined or calculated time relative to a predetermined or calculated impedance, a change in electrode impedance over a specified time, or a change in electrode impedance relative to a change in temperature in or near the electrode over a specified time.

18. The method of claim 1 wherein evaluating the set of treatment data comprises performing a linear discriminant analysis to generate a score and using the score to determine whether the completed neuromodulation treatment was within the pre-determined range or if the completed treatment did not proceed as expected.

19. A method for renal neuromodulation treatment of a human patient via an electrode positioned within a renal artery of the patient, the method comprising:

delivering radio frequency (RF) energy, via the electrode, to target renal nerves proximate the renal artery, wherein delivering RF energy comprises—

increasing energy delivery to the electrode a predetermined first power level over a first period of time;

maintaining energy delivery at the predetermined first power level for a second period of time; and

increasing energy delivery to a predetermined second power level if the temperature value measured in or near the electrode is less than a preset threshold temperature following the second period of time,

wherein the increase in energy delivery following the second period of time continues until the power level has reached a target maximum power threshold; and

evaluating the renal neuromodulation treatment of the patient, wherein the evaluation comprises—

obtaining a set of treatment data corresponding to a completed renal neuromodulation treatment;

evaluating the set of treatment data in view of one or more criteria to determine if a valuation of the completed renal neuromodulation treatment is within a pre-determined range; and

providing an indication as to whether the valuation of the completed renal neuromodulation treatment is within the pre-determined range.

20. The method of claim 19 wherein delivering RF energy, via the electrode, to target renal nerves comprises at least partially ablating the target renal nerves.

21. The method of claim 19 wherein:

evaluating the set of treatment data comprises generating a score used to determine whether the completed renal neuromodulation treatment was within the pre-determined range or if the completed renal neuromodulation treatment did not proceed as expected;

providing an indication as to whether the completed renal neuromodulation treatment was within the pre-determined range comprises (a) displaying a first message on a display screen if the valuation of the renal neuromodulation treatment is within the pre-determined range, and (b) displaying a second, different message on the display screen if the valuation of the renal neuromodulation treatment indicated that treatment did not proceed as expected.