System and method for performing renal denervation verification

• US 9,427,579 B2
• Filed: 09/29/2011
• Issued: 08/30/2016
• Est. Priority Date: 09/29/2011
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fain, Eric S., Cholette, Martin, Dulak, Gary R., Bornzin, Gene A., Poore, John W.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US13/248,818
• Publication Number:
  US 20130085489A1
• Time in Patent Office: 1,797 Days
• Field of Search: 606/34
• 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 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A renal denervation feedback method is described that performs a baseline measurement of renal nerve plexus electrical activity at a renal vessel; denervates at least some tissue proximate the renal vessel after performing the baseline measurement; performs a post-denervation measurement of renal nerve plexus electrical activity at the renal vessel, after the denervating; and assesses denervation of the renal vessel based on a comparison of the baseline measurement and the post-denervation measurement of renal nerve plexus electrical activity at the renal vessel.

Claims

1. A renal denervation feedback method comprising:

performing a baseline measurement of intrinsic renal nerve plexus electrical activity at a renal vessel by monitoring compound action potentials;

denervating at least some tissue proximate the renal vessel after performing the baseline measurement;

performing a post-denervation measurement of renal nerve plexus electrical activity at the renal vessel by monitoring compound action potentials, after the denervating; and

assessing denervation of the renal vessel based on a comparison of the baseline measurement and the post-denervation measurement of renal nerve plexus electrical activity at the renal vessel.

2. The renal denervation feedback method of claim 1, further comprising, if a target denervation of the renal vessel is not achieved:

repeating the steps of denervating, performing a post-denervation measurement, and assessing denervation of the renal vessel until the target denervation of the renal vessel is achieved.

3. The renal denervation feedback method of claim 2, wherein repeating the steps of denervating, performing a post-denervation measurement, and assessing denervation of the renal vessel comprises:

adjusting a level of denervation for denervating at least some tissue proximate the renal vessel based on result of assessing denervation of the renal vessel.

4. The renal denervation feedback method of claim 1,

wherein performing a baseline measurement comprises monitoring baseline afferent signals and baseline efferent signals at the renal vessel without external stimulation to the renal vessel;

and

wherein performing a post-denervation measurement comprises monitoring post-denervation afferent signals and post-denervation efferent signals at the renal vessel without external stimulation to the renal vessel, after the denervating.

5. The renal denervation feedback method of claim 4,

wherein monitoring the baseline afferent signals and baseline efferent signals comprises monitoring baseline afferent compound action potential and baseline efferent compound action potential, counting a number of baseline afferent spikes each representing an afferent compound action potential that exceeds a preset threshold during a specified period of time, and counting a number of baseline efferent spikes each representing an efferent compound action potential that exceeds the preset threshold during the specified period of time;

and

wherein monitoring the post-denervation afferent signals and post-denervation efferent signals comprises monitoring post-denervation afferent compound action potential and post-denervation efferent compound action potential, counting a number of post-denervation afferent spikes each representing an afferent compound action potential that exceeds the preset threshold during the specified period of time, and counting a number of post-denervation efferent spikes each representing an efferent compound action potential that exceeds the preset threshold during the specified period of time.

6. The renal denervation feedback method of claim 5,

wherein the baseline measurement and the post-denervation measurement occur at a location of the renal vessel proximal of a kidney and proximal of a denervation location for denervating at least some tissue proximate the renal vessel;

and

wherein the target denervation of the renal vessel is achieved when a ratio of the number of post-denervation afferent spikes to the number of post-denervation efferent spikes is below a preset threshold as compared to a ratio of the number of baseline afferent spikes to the number of baseline efferent spikes.

7. The renal denervation feedback method of claim 5,

wherein the baseline measurement and the post-denervation measurement occur at a location of the renal vessel proximal of a kidney and distal of a denervation location for denervating at least some tissue proximate the renal vessel;

and

wherein the target denervation of the renal vessel is achieved when a ratio of the number of post-denervation afferent spikes to the number of post-denervation efferent spikes is above a preset threshold as compared to a ratio of the number of baseline afferent spikes to the number of baseline efferent spikes.

8. The renal denervation feedback method of claim 1,

wherein performing a baseline measurement comprises supplying nerve stimulation to the renal vessel from one side of a denervation location for denervating at least some tissue proximate the renal vessel and measuring a baseline response of the renal vessel to the nerve stimulation on an opposite side of the denervation location;

and

wherein performing a post-denervation measurement comprises supplying nerve stimulation to the renal vessel from one side of the denervation location and measuring a post-denervation response of the renal vessel to the nerve stimulation on an opposite side of the denervation location.

9. The renal denervation feedback method of claim 8,

wherein the same nerve stimulation is supplied from a same first location on the same side of the denervation location for both the baseline measurement and the post-denervation measurement, and the response is recorded on a same second location on the same opposite side of the denervation location for both the baseline measurement and the post-denervation measurement.

10. The renal denervation feedback method of claim 8,

wherein the nerve stimulation is supplied from the proximal side of the denervation location for both the baseline measurement and the post-denervation measurement, and the response is recorded on the distal side of the denervation location for both the baseline measurement and the post-denervation measurement.

11. The renal denervation feedback method of claim 8,

wherein the nerve stimulation comprises one of electrical stimulation or pharmacological stimulation.

12. The renal denervation feedback method of claim 8, wherein assessing denervation of the vessel comprises:

computing a baseline parameter from the baseline response;

computing a post-denervation parameter from the post-denervation response; and

computing a degree of denervation as a ratio of the post-denervation parameter and the baseline parameter;

wherein the target denervation is achieved when the computed ratio falls within a preset range.

13. The renal denervation feedback method of claim 12,

wherein the baseline parameter comprises a number of baseline spikes each representing a compound action potential that exceeds a preset threshold during a specified period of time as measured in the baseline response;

wherein the post-denervation parameter comprises a number of post-denervation spikes each representing a compound action potential that exceeds the same preset threshold during the same specified period of time as measured in the post-denervation response; and

wherein the target denervation is achieved when the computed ratio falls below a preset number.

14. The renal denervation feedback method of claim 1,

wherein performing a baseline measurement comprises supplying nerve stimulation to the renal vessel from a first side of a denervation location for denervating at least some tissue proximate the renal vessel and measuring a first baseline response of the renal vessel to the nerve stimulation on a second side of the denervation location opposite the first side, and supplying nerve stimulation to the renal vessel from the second side and measuring a second baseline response of the renal vessel to the nerve stimulation on the first side;

and

wherein performing a post-denervation measurement comprises supplying nerve stimulation to the renal vessel from the first side and measuring a first post-denervation response of the renal vessel to the nerve stimulation on the second side, and supplying nerve stimulation to the renal vessel from the second side and measuring a second post-denervation response of the renal vessel to the nerve stimulation on the first side.

15. The renal denervation feedback method of claim 14,

wherein performing a baseline measurement comprises supplying nerve stimulation to the renal vessel from a first location on the first side of the denervation location and measuring the first baseline response of the renal vessel to the nerve stimulation on a second location on the second side, and supplying nerve stimulation to the renal vessel from the second location and measuring the second baseline response of the renal vessel to the nerve stimulation at the first location;

and

wherein performing a post-denervation measurement comprises supplying nerve stimulation to the renal vessel from the first location and measuring the first post-denervation response of the renal vessel to the nerve stimulation at the second location, and supplying nerve stimulation to the renal vessel from the second location and measuring the second post-denervation response of the renal vessel to the nerve stimulation at the first location.

16. The renal denervation feedback method of claim 14,

wherein measuring the first baseline response comprises filtering the first baseline response to increase signal-to-noise ratio;

wherein measuring the second baseline response comprises filtering the second baseline response to increase signal-to-noise ratio;

wherein measuring the first post-denervation response comprises filtering the first baseline response to increase signal-to-noise ratio; and

wherein measuring the second post-denervation response comprises filtering the second baseline response to increase signal-to-noise ratio.

17. The renal denervation feedback method of claim 14,

wherein measuring the first baseline response comprises synchronizing with electrocardiogram to substantially avoid detected signals other than detected signals that are recorded during electrically quiet times;

wherein measuring the second baseline response comprises synchronizing with electrocardiogram to substantially avoid detected signals other than detected signals that are recorded during electrically quiet times;

wherein measuring the first post-denervation response comprises synchronizing with electrocardiogram to substantially avoid detected signals other than detected signals that are recorded during electrically quiet times; and

wherein measuring the second post-denervation response comprises synchronizing with electrocardiogram to substantially avoid detected signals other than detected signals that are recorded during electrically quiet times.

18. The renal denervation feedback method of claim 14,

wherein measuring the first baseline response comprises epoch averaging of multiple epochs relative to stimulus of the nerve stimulation to increase signal-to-noise ratio;

wherein measuring the second baseline response comprises epoch averaging of multiple epochs relative to stimulus of the nerve stimulation to increase signal-to-noise ratio;

wherein measuring the first post-denervation response comprises epoch averaging of multiple epochs relative to stimulus of the nerve stimulation to increase signal-to-noise ratio; and

wherein measuring the second post-denervation response comprises epoch averaging of multiple epochs relative to stimulus of the nerve stimulation to increase signal-to-noise ratio.

19. The renal denervation feedback method of claim 14,

wherein the nerve stimulation is multiphasic stimulation.

20. The renal denervation feedback method of claim 14,

wherein the nerve stimulation is supplied via one or more electrodes made of low polarization electrode material.

21. The renal denervation feedback method of claim 14,

wherein the nerve stimulation has a narrow pulse width selected to reduce stimulus polarization.

22. The renal denervation feedback method of claim 14,

wherein the nerve stimulation has a pulse width substantially equal to chronaxie of the renal vessel.

23. A renal denervation feedback system, comprising:

at least one denervation member to denervate at least some tissue proximate the renal vessel;

at least one measurement member to perform a baseline measurement of intrinsic renal nerve plexus electrical activity at a renal vessel before denervation of at least some tissue proximate the renal vessel and to perform a post-denervation measurement of renal nerve plexus electrical activity at the renal vessel after the denervation, the baseline and post-denervation measurements acquired by monitoring compound action potentials; and

a denervation assessment module to assess denervation of the renal vessel based on a comparison of the baseline measurement and the post-denervation measurement of renal nerve plexus electrical activity at the renal vessel.

24. The renal denervation feedback apparatus of claim 23, further comprising a denervation control module configured, if a target denervation of the renal vessel is not achieved, to:

instruct operation of the at least one denervation member to repeat denervating at least some tissue proximate the renal vessel, instruct operation of the at least one measurement member to repeat performing a post-denervation measurement, and instruct the denervation assessment module to repeat assessing denervation of the renal vessel, until the target denervation of the renal vessel is achieved.

25. The renal denervation feedback method of claim 24, wherein repeating the denervating, performing a post-denervation measurement, and assessing denervation of the renal vessel comprises:

adjusting a level of denervation for denervating at least some tissue proximate the renal vessel based on result of assessing denervation of the renal vessel.