System and method for performing renal denervation verification

• US 10,376,310 B2
• Filed: 09/27/2017
• Issued: 08/13/2019
• 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:
  US15/716,967
• Publication Number:
  US 20180014882A1
• Time in Patent Office: 685 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 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 including baseline afferent and efferent signals;

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

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

determining the denervation is complete when the post-denervation compound action potentials include solely afferent signals.

2. The renal denervation feedback method of claim 1, further comprising, if the denervation is not complete:

repeating the steps of denervating and performing a post-denervation measurement until the post-denervation compound action potentials are solely afferent signals.

3. The renal denervation feedback method of claim 1, wherein performing the baseline measurement of renal nerve plexus electrical activity comprises:

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.

4. The renal denervation feedback method of claim 1, wherein performing a post-denervation measurement of renal nerve plexus electrical activity comprises:

counting a number of post-denervation afferent spikes each representing an afferent compound action potential that exceeds a preset threshold during a specified period of time.

5. The renal denervation feedback method of claim 4, wherein performing a post-denervation measurement of renal nerve plexus electrical activity further comprises, if the denervation is not complete:

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 1, wherein monitoring compound action potentials comprises using a plurality of bi-polar measurement electrodes to measure the post-denervation afferent signals.

7. The renal denervation feedback method of claim 6, wherein monitoring compound action potentials further comprises, if the denervation is not complete, using a plurality of bi-polar measurement electrodes to measure post-denervation efferent signals.

8. The renal denervation feedback method of claim 1, wherein denervating at least some tissue at a denervation location proximate the renal vessel after performing the baseline measurement comprises using at least one denervation electrode to denervate the at least some tissue.

9. A renal denervation feedback system comprising:

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

at least one measurement member to perform a baseline measurement of intrinsic renal nerve plexus electrical activity, including baseline afferent and efferent signals, at the renal vessel before denervation of the at least some tissue proximate the renal vessel and to perform a post-denervation measurement of renal nerve plexus electrical activity at a measurement location on a distal side of the denervation location 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, wherein the denervation assessment module is configured to determine the denervation is complete when the post-denervation compound action potentials include solely afferent signals.

10. The renal denervation system of claim 9, wherein, if the denervation is not complete, the denervation assessment module is further configured to direct the at least one denervation member to repeat denervation of the at least some tissue.

11. The renal denervation system of claim 9, wherein the denervation assessment module is further configured to direct the at least one denervation member to adjust a level of denervation for denervating the at least some tissue at the denervation location proximate the renal vessel.

12. The renal denervation system of claim 9, wherein the at least one measurement member is further configured to perform the post-denervation measurement of renal nerve plexus electrical activity by counting a number of post-denervation afferent spikes each representing an afferent compound action potential that exceeds a preset threshold during a specified period of time.

13. The renal denervation system of claim 12, wherein, if the denervation is not complete, the at least one measurement member is further configured to perform the post-denervation measurement of renal nerve plexus electrical activity by 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.

14. The renal denervation system of claim 9, wherein the at least one measurement member comprises a plurality of bi-polar measurement electrodes.

15. The renal denervation system of claim 9, wherein the at least one denervation member comprises at least one denervation electrode.

16. The renal denervation system of claim 9, wherein the at least one measurement member is configured to perform the baseline measurement of renal nerve plexus electrical activity by:

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.