USING CHARACTERISTICS OF NATIVE OR EVOKED SENSED NEURAL ACTIVITY TO SELECT DENERVATION PARAMETERS

Abstract

Tissue treatment systems and methods are disclosed. A tissue treatment system comprises a signal generator, a sensing circuit coupleable to electrode(s) of a catheter, and a controller. The sensing circuit senses neural activity of nerves within tissue surrounding a biological lumen using electrode(s) of the catheter inserted into the biological lumen. The controller determines one or more characteristics of the sensed neural activity of the nerves within the tissue surrounding the biological lumen. The controller also selects one or more denervation parameters based on the one or more characteristics of the sensed neural activity, and controls the signal generator to generate, using the selected one or more denervation parameters, signals for performing a denervation procedure intended to denervate at least some of the nerves for which the neural activity was sensed.

Description

Claims

1. A tissue treatment system, comprising: a signal generator;a sensing circuit coupleable to at least one electrode of a catheter that is insertable into a biological lumen, the sensing circuit configured to sense neural activity of nerves within tissue surrounding the biological lumen using the at least one electrode of the catheter while the catheter is inserted into the biological lumen; anda controller communicatively coupled to the signal generator and the sensing circuit;the controller comprising one or more processors and configured to: determine one or more characteristics of the sensed neural activity of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one electrode of the catheter;select one or more denervation parameters based on the one or more characteristics of the sensed neural activity; andcontrol the signal generator to generate, using the selected one or more denervation parameters, signals for performing a denervation procedure intended to denervate at least some of the nerves for which the neural activity was sensed.

2. The system of claim 1, further comprising the catheter, wherein: the sensing circuit is configured to sense the neural activity of the nerves using the at least one electrode; andthe signal generator is configured to generate the signals for performing the denervation procedure.

3. The system of claim 2, wherein: the sensing circuit is configured to sense evoked neural activity of the nerves within the tissue surrounding the biological lumen using the at least one electrode of the catheter; andthe evoked neural activity is responsive to electrical stimulation delivered using at least one other electrode of the catheter.

4. The system of claim 1, further comprising: a first catheter comprising the at least one electrode; anda second catheter comprising at least one electrode configured to emit radio frequency (RF) energy and/or an ultrasound transducer configured to emit ultrasound energy;wherein the sensing circuit is configured to sense the neural activity of the nerves using the at least one electrode of the first catheter; andwherein the signal generator is configured to generate the signals for performing the denervation procedure using the at least one electrode of the second catheter, or the ultrasound transducer of the second catheter.

5. The system of claim 1, wherein the one or more denervation parameters selected by the controller comprise one or more of amplitude, power, duration, frequency, and duty cycle of ultrasound energy emitted by an ultrasound transducer.

6. The system of claim 5, wherein the ultrasound transducer is located within a balloon that is at least partially filled with a cooling fluid that is circulated through the balloon in order to cool at least a portion of the tissue surrounding the biological lumen proximate the balloon, and wherein the one or more denervation parameters selected by the controller also comprise at least one of a flow rate or a temperature associated with the cooling fluid.

7. The system of claim 1, wherein the denervation parameters selected by the controller comprise one or more of amplitude, power, duration, frequency, and duty cycle of radio frequency (RF) energy emitted by at least one electrode.

8. The system of claim 1, wherein the controller is configured to: determine at least one of the one or more characteristics of the sensed neural activity by determining a minimal amount of stimulation energy needed to evoke a neural response by the nerves within tissue surrounding the biological lumen; andselect the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the minimal amount of stimulation energy needed to evoke the neural response by the nerves within tissue surrounding the biological lumen.

9. The system of claim 1, wherein the controller is configured to: determine at least one of the one or more characteristics of the sensed neural activity by determining an amount of stimulation energy needed to cause saturation of an evoked neural response of the nerves within tissue surrounding the biological lumen; andselect the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the amount of stimulation energy needed to cause saturation of the evoked neural response of the nerves within tissue surrounding the biological lumen.

10. The system of claim 1, wherein the controller is configured to select at least one of the one or more denervation parameters using one or more tables accessed by the controller from a memory.

11. The system of claim 1, wherein the controller is configured to select at least one of the one or more denervation parameters using a machine learning model implemented by at least one of the one or more processors of the controller.

12. The system of claim 1, wherein: the sensing circuit is configured to sense the neural activity of the nerves within the tissue surrounding the biological lumen by sensing a signal indicative of the neural activity, the signal indicative of the neural activity including multiple peaks temporally spaced apart from one another; andthe controller is configured to determine at least one of the one or more characteristics of the sensed neural activity based on at least one of amplitudes of the multiple peaks or based on temporal spacings between the multiple peaks.

13. The system of claim 12, wherein the controller is configured to: determine at least one of the one or more characteristics of the sensed neural activity by determining an average amplitude or a median amplitude of the multiple peaks; andselect the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the average amplitude or the median amplitude of the multiple peaks.

14. The system of claim 12, wherein the controller is configured to: determine at least one of the one or more characteristics of the sensed neural activity by fitting a curve to a portion of the signal indicative of the neural activity, and determining an area under the curve; andselect the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the area under the curve.

15. The system of claim 12, wherein the controller is configured to: determine at least one of the one or more characteristics of the sensed neural activity by determining temporal spacings between at least some of the multiple peaks relative to a cardiac cycle; andselect the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the temporal spacings between the at least some of the multiple peaks relative to the cardiac cycle.

16. The system of claim 1, wherein the controller is further configured to diagnose a disease state based on at least one of the one or more characteristics of the sensed neural activity.

17. The system of claim 1, wherein the biological lumen comprises a renal artery and the nerves comprise renal nerves innervating a kidney.

18. The system of claim 1, wherein the sensing circuit is configured to sense spontaneous neural activity of the nerves within the tissue surrounding the biological lumen using the at least one electrode of the catheter.

19. A tissue treatment method, comprising: sensing neural activity of nerves within tissue surrounding a biological lumen;determining one or more characteristics of the sensed neural activity of the nerves within the tissue surround the biological lumen, the one or more characteristics indicative of one or more of a size, type, function, or health of the nerves, and/or proximity of the nerves relative to at least one electrode of a catheter inserted in the biological lumen;selecting one or more denervation parameters based on the one or more characteristics of the sensed neural activity, the one or more denervation parameters for use in performing a denervation procedure intended to denervate at least some of the nerves for which the neural activity was sensed, the selecting one or more denervation parameters performed using one or more processors; andperforming the denervation procedure using the one or more denervation parameters selected to thereby denervate at least some of the nerves for which the neural activity was sensed.

20. The method of claim 19, wherein the biological lumen comprises a renal artery and the nerves comprise renal nerves innervating a kidney.

21. The method of claim 19, wherein the neural activity that is sensed comprises spontaneous neural activity.

22. The method of claim 19, wherein the neural activity that is sensed comprises evoked neural activity that is responsive to electrical stimulation delivered using the same catheter used to sense the evoked neural activity.

23. The method of claim 19, wherein: the determining the one or more characteristics of the sensed neural activity comprises determining a minimal amount of stimulation energy needed to evoke a neural response by the nerves within tissue surrounding the biological lumen; andthe selecting the one or more denervation parameters based on the one or more characteristics of the sensed neural activity comprises selecting at least one of the one or more denervation parameters based on the minimal amount of stimulation energy needed to evoke the neural response by the nerves within tissue surrounding the biological lumen.

24. The method of claim 19, wherein: the determining the one or more characteristics of the sensed neural activity comprises determining an amount of stimulation energy needed to cause saturation of an evoked neural response of the nerves within tissue surrounding the biological lumen; andthe selecting the one or more denervation parameters based on the one or more characteristics of the sensed neural activity comprises selecting at least one of the one or more denervation parameters based on the amount of stimulation energy needed to cause saturation of the evoked neural response of the nerves within tissue surrounding the biological lumen.

25. The method of claim 19, wherein the performing the denervation procedure comprising using an ultrasound transducer inserted into the biological lumen to emit ultrasound energy, and wherein the one or more denervation parameters selected comprise one or more of amplitude, power, duration, frequency, and duty cycle of the ultrasound energy.

26. The method of claim 25, wherein the ultrasound transducer is located within a balloon that is at least partially filled with a cooling fluid that is circulated through the balloon in order to cool at least a portion of the tissue surrounding the biological lumen proximate the balloon, and wherein the one or more denervation parameters selected also specify at least one of a flow rate or a temperature associated with the cooling fluid.

27. The method of claim 19, wherein the performing the denervation procedure comprising using one or more electrodes inserted into the biological lumen to emit RF energy, and wherein the one or more denervation parameters selected comprise one or more of amplitude, power, duration, frequency, and duty cycle of the RF energy.

28. The method of claim 19, wherein the selecting the one or more denervation parameters is performed using one or more tables accessed by at least one of the one or more processors.

29. The method of claim 19, wherein the selecting the one or more denervation parameters is performed using a machine learning model implemented by at least one of the one or more processors.

30. The method of claim 19, wherein: the sensing neural activity of the nerves within the tissue surrounding the biological lumen comprises sensing a signal indicative of the neural activity, the signal indicative of the neural activity including multiple peaks temporally spaced apart from one another; andthe determining the one or more characteristics of the sensed neural activity comprises determining at least one of the one or more characteristics based on at least one of amplitudes of the multiple peaks or temporal spacings between the multiple peaks.

31. The method of claim 30, wherein: the determining the one or more characteristics of the sensed neural activity comprises determining an average amplitude or a median amplitude of the multiple peaks; andthe selecting the one or more denervation parameters based on the one or more characteristics of the sensed neural activity comprises selecting at least one of the one or more denervation parameters based on the average amplitude or the median amplitude of the multiple peaks.

32. The method of claim 31, wherein: the determining the one or more characteristics of the sensed neural activity comprises fitting a curve to a portion of the signal indicative of the neural activity, and determining an area under the curve; andthe selecting the one or more denervation parameters based on the one or more characteristics of the sensed neural activity comprises selecting at least one of the one or more denervation parameters based on the area under the curve.

33. The method of claim 30, wherein: the determining the one or more characteristics of the sensed neural activity comprises determining temporal spacings between at least some of the multiple peaks relative to a cardiac cycle; andthe selecting the one or more denervation parameters based on the one or more characteristics of the sensed neural activity comprises selecting at least one of the one or more denervation parameters based on the temporal spacings between the at least some of the multiple peaks relative to the cardiac cycle.

34. The method of claim 19, further comprising: diagnosing a disease state based on at least one of the one or more characteristics of the sensed neural activity.

35. The method of claim 19, wherein: the sensing is performed using at least one electrode of a catheter inserted into the biological lumen; andthe denervation procedure is performed using the same catheter used to sense the neural activity, or using a separate catheter inserted into the biological lumen after the catheter used to sense the neural activity has been removed.