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

• US 9,066,720 B2
• Filed: 10/25/2011
• Issued: 06/30/2015
• 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, Friedrichs, Paul, Wu, Andrew, Zarins, Denise, Herzfeld, David, Leung, Mark S.
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US13/281,269
• Publication Number:
  US 20120101538A1
• Time in Patent Office: 1,344 Days
• Field of Search: 606/41
• US Class Current: 1/1
• 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. An energy source for renal neuromodulation configured for connecting to a catheter having a distal portion comprising an energy delivery element configured for placement at a treatment site within a renal blood vessel, the energy source adapted to be coupled to the energy delivery element and configured to deliver energy via the energy delivery element to target neural fibers proximate to a wall of the renal blood vessel,

wherein the energy source comprises a component configured to—

increase energy delivery to a predetermined first power level over a first period of time;

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

increase energy delivery to a second predetermined power level if the temperature value is less than a preset threshold temperature following the second period of time; and

wherein the energy source further comprises a component configured to—

obtain a set of treatment data corresponding to a completed treatment performed using the catheter, the energy source, and the energy delivery element;

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

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

2. The energy source of claim 1 wherein the set of treatment data is a first set of treatment data corresponding to a first completed treatment, and wherein the energy source is further configured to—

modify 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 treatment is within the pre-determined range;

perform a second 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

obtain a second set of treatment data corresponding to a second completed treatment.

3. The energy source of claim 1 wherein the set of treatment data comprises data related to one or more of a temperature-based measure, an impedance-based measure, a blood flow-based measure, or a movement-based determination.

4. The energy source of claim 1 wherein the set of treatment data comprises one or more measurements related to a change in temperature over a specified time, a maximum temperature, a maximum average temperature, a minimum temperature, a temperature at a predetermined or calculated time relative to a predetermined or calculated temperature, an average temperature over a specified time, a maximum blood flow, a minimum blood flow, a blood flow at a predetermined or calculated time relative to a predetermined or calculated blood flow, an average blood flow over time, a maximum impedance, a minimum impedance, an impedance at a predetermined or calculated time relative to a predetermined or calculated impedance, a change in impedance over a specified time, or a change in impedance relative to a change in temperature over a specified time.

5. The energy source of claim 1 wherein:

the energy delivery element comprises a first energy delivery element, and wherein the catheter distal portion further comprises a second energy delivery coupled to the energy source and configured to deliver energy to the target neural fibers; and

the set of treatment data comprises a first set of data related to an impedance-based measure of the first energy delivery element and a second set of data related to an impedance-based measure of the second energy delivery element.

6. The energy source of claim 5 wherein evaluating the set of treatment data in view of one or more criteria comprises comparing the first set of data with the second set of data.

7. The energy source of claim 1 wherein evaluating the set of treatment data comprises generating a score used to determine whether the completed treatment was successful.

8. The energy source of claim 1 wherein evaluating the set of treatment data comprises performing a linear discriminant analysis.

9. The energy source of claim 8 wherein the linear discriminant analysis generates a score used to determine whether the completed treatment was successful.

10. The energy source of claim 1, further comprising a display screen, and wherein the provided indication comprises a message displayed on the display screen.

11. The energy source of claim 10 wherein the catheter distal portion further comprises an impedance sensor for measuring an impedance of the treatment site or the energy delivery element, and wherein the energy source is further configured to track impedance measurements in real time over a selected period of time and display the real time impedance measurements on the display screen.

12. A computer-readable storage medium containing instructions that, when executed by a computer, perform operations comprising:

increasing energy delivery to an energy delivery element carried by a catheter, wherein energy delivery is increased to a pre-determined first power level over a first period of time, and wherein the energy delivery element is positioned to deliver energy to target neural fibers proximate to a wall of a renal blood vessel of a human patient;

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

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

obtaining a set of treatment data corresponding to a completed treatment performed using the energy delivery element;

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

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

13. The computer-readable storage medium of claim 12 wherein the set of treatment data comprises data related to one or more of a temperature-based measure, an impedance-based measure, a blood flow-based measure, or a movement-based determination.

14. The computer-readable storage medium of claim 12 wherein the operating parameter comprises one or more of temperature, time, impedance, power, blood flow, flow velocity, volumetric flow rate, blood pressure, or heart rate.

15. The computer-readable storage medium of claim 12 wherein the set of treatment data comprises one or more measurements related to a change in temperature over a specified time, a maximum temperature, a maximum average temperature, a minimum temperature, a temperature at a predetermined or calculated time relative to a predetermined or calculated temperature, an average temperature over a specified time, a maximum blood flow, a minimum blood flow, a blood flow at a predetermined or calculated time relative to a predetermined or calculated blood flow, an average blood flow over time, a maximum impedance, a minimum impedance, an impedance at a predetermined or calculated time relative to a predetermined or calculated impedance, a change in impedance over a specified time, or a change in impedance relative to a change in temperature over a specified time.

16. The computer-readable storage medium of claim 12 wherein the set of treatment data comprises a first set of treatment data corresponding to a first completed treatment, and wherein the operations further comprise:

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 treatment is within the pre-determined range;

performing a second 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 treatment.

17. The computer-readable storage medium of claim 12 wherein evaluating the set of treatment data comprises generating a score used to determine whether the completed treatment was within the pre-determined range or if the completed treatment did not proceed as expected.

18. The computer-readable storage medium of claim 12 wherein evaluating the set of treatment data comprises performing a linear discriminant analysis.

19. The computer-readable storage medium of claim 17 wherein the linear discriminant analysis generates a score used to determine whether the completed treatment was within the pre-determined range.

20. The computer-readable storage medium of claim 12 wherein the provided indication comprises a message displayed on a display screen of a system used to administer the completed treatment.

21. The computer-readable storage medium of claim 20 wherein providing an indication as to whether the completed treatment was within the pre-determined range comprises:

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

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

22. The computer-readable storage medium of claim 12 wherein increasing energy delivery to a predetermined second power level if an operating parameter is outside a pre-determined range comprises increasing energy delivery to a pre-determined second power level if a difference in impedance values from a first energy delivery element and a second energy delivery element is outside a pre-determined range.