Neuromodulation systems having nerve monitoring assemblies and associated devices, systems, and methods

Patent metadata

Field	Value
Publication number	US-9326816-B2
Application number	US-201314015793-A
Country	US
Kind code	B2
Filing date	Aug 30, 2013
Priority date	Aug 30, 2013
Publication date	May 3, 2016
Grant date	May 3, 2016

Abstract

Neuromodulation systems with nerve monitoring assemblies and associated devices, systems, and methods are disclosed herein. A neuromodulation system configured in accordance with some embodiments of the present technology can include, for example, a generator, a nerve monitoring assembly configured to detect electroneurogram (ENG) signals, and a neuromodulation catheter. The neuromodulation catheter can include an elongated shaft with a distal portion and a proximal portion. The distal portion of the shaft can include an array of electrodes configured to detect nerve activity from within a blood vessel of a human. The proximal portion of the shaft can include at least one connector that operably couples the electrodes to the generator and to the nerve monitoring assembly.

First claim

I claim:

1. A method of monitoring nerve activity associated with treating a nerve, the method comprising:
delivering a distal portion of a neuromodulation catheter to a target site within a blood vessel of a human patient, wherein the distal portion comprises a plurality of contacts;
detecting electroneurogram (ENG) signals with a nerve monitoring assembly operably coupled to the contacts, wherein the ENG signals are taken from recordings of nerve activity at the contacts;
distinguishing electromyogram (EMG) signals from ENG signals with the nerve monitoring assembly;
delivering neuromodulation energy to the target site via an energy delivery element;
detecting ENG signals with the nerve monitoring assembly proximate to the target site after delivering the neuromodulation energy; and
comparing the ENG signals recorded before and after the neuromodulation energy is delivered, wherein a decrease in a parameter of the ENG signals after neuromodulation indicates sufficient target of nerves proximate to the target site.

2. The method of claim 1 wherein the contacts are electrodes, and wherein:
detecting ENG signals comprises recording nerve activity with the electrodes; and
delivering neuromodulation energy to the target site comprises delivering RF energy to the target site via the electrodes.

3. The method of claim 1 wherein the detecting ENG signals comprises:
recording neural signals at a plurality of locations proximate to the target site; and
averaging the neural signals taken at the plurality of locations.

4. The method of claim 1 , further comprising:
stimulating the nerves proximate to the target site with a first contact of the plurality of contacts, wherein the nerves are stimulated with a non-therapeutic level of energy; and
recording nerve activity resulting from the stimulation with at least a second contact and a third contact of the plurality of contacts.

5. The method of claim 1 wherein distinguishing EMG signals from ENG signals with the nerve monitoring assembly comprises distinguishing the EMG signals from the ENG signals using at least one amplifier coupled to the contacts in a quasi-tripole (QT) circuit.

6. The method of claim 1 wherein distinguishing EMG signals from ENG signals with the nerve monitoring assembly comprises distinguishing the EMG signals from the ENG signals using a plurality of amplifiers coupled to the contacts in a true-tripole (TT) circuit.

7. The method of claim 1 wherein distinguishing EMG signals from ENG signals with the nerve monitoring assembly comprises distinguishing the EMG signals from the ENG signals using a plurality of amplifiers coupled to the contacts in an adaptive tripole (AT) circuit.

8. The method of claim 1 wherein the energy delivery element comprises an array of electrodes, wherein the electrodes define the contacts, and wherein delivering neuromodulation energy to the target site via the energy delivery element comprises delivering RF energy via the electrodes to a vessel wall at the target site.

9. The method of claim 1 wherein the energy delivery element comprises a radiation emitter, and wherein delivering neuromodulation energy to the target site via the energy delivery element comprises delivering radiation to a vessel wall at the target site.

10. The method of claim 1 wherein the energy delivery element comprises an ultrasound source, and wherein delivering neuromodulation energy to the target site via the energy delivery element comprises delivering ultrasound waves to a vessel wall at the target site.

11. The method of claim 1 wherein the energy delivery element comprises a cryotherapeutic applicator, and wherein delivering neuromodulation energy to the target site via the energy delivery element comprises delivering cryotherapeutic cooling to a vessel wall at the target site.

12. A neuromodulation system for treating a human patient, comprising:
a generator configured to remain external to the patient;
a nerve monitoring assembly configured to detect electroneurogram (ENG) signals and distinguish the ENG signals from electromyogram (EMG) signals; and
a neuromodulation catheter having an elongated shaft with a distal portion configured for intravascular delivery within the patient and a proximal portion,
wherein the distal portion comprises an array of electrodes configured to detect nerve activity from within a blood vessel of the patient, and
wherein the proximal portion comprises at least one connector operably coupling the electrodes to the generator and to the nerve monitoring assembly.

13. The neuromodulation system of claim 12 wherein the electrodes are configured to deliver therapeutically effective energy to a target site in the blood vessel to modulate neural fibers proximate to the target site.

14. The neuromodulation system of claim 12 wherein the distal portion of the neuromodulation catheter comprises a support member having a spiral shape and configured to contact an interior wall of the blood vessel when the support member is in a deployed state, and wherein the electrodes are spaced apart from each other along a length of the support member.

15. The neuromodulation system of claim 12 wherein the distal portion of the neuromodulation catheter comprises a plurality of supports that define a basket structure configured to contact an interior wall of the blood vessel when the supports are in a deployed state, and wherein the electrodes are arranged along the supports.

16. The neuromodulation system of claim 12 wherein the distal portion of the neuromodulation catheter comprises a mesh structure configured to contact an interior wall of the blood vessel when the mesh structure is in a deployed state, and wherein the electrodes are arranged along the mesh structure.

17. The neuromodulation system of claim 12 wherein the distal portion of the neuromodulation catheter comprises a balloon carrying the electrodes, and wherein the balloon is configured to place the electrodes into contact with an interior wall of the blood vessel when expanded.

18. The neuromodulation system of claim 12 wherein:
the nerve monitoring assembly includes at least one amplifier arranged in a quasi-tripole (QT) circuit; and
the array of electrodes comprises at least a first electrode and a second electrode electrically coupled to the amplifier.

19. The neuromodulation system of claim 12 wherein:
the nerve monitoring assembly includes a first amplifier, a second amplifier, and a third amplifier arranged in a true-tripole (TT) circuit, wherein the first and second amplifiers are electrically coupled to the third amplifier; and
the array of electrodes comprises at least a first electrode, a second electrode, and a third electrode, wherein the first and second electrodes are coupled together to define a first electrode pair and the second and third electrodes are coupled together to define a second electrode pair, and wherein the first and second electrode pairs are operably coupled to the first and second amplifiers, respectively.

20. The neuromodulation system of claim 12 wherein the nerve monitoring assembly includes a plurality of amplifiers electrically coupled to the electrodes in an adaptive tripole (AT) circuit.

21. The neuromodulation system of claim 12 wherein the generator and the nerve monitoring assembly are integrated with each other in a console configured to remain external to the patient.

22. A neuromodulation catheter, comprising:
an elongated shaft having a distal portio

Assignees

• Medtronic Ardian Luxembourg

Inventors

• Srivastava Nishant R

Classifications

• A61B5/388

  Nerve conduction study, e.g. detecting action potential of peripheral nerves · CPC title

• A61B18/1492 Primary

  having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence) · CPC title

• A61B2018/00434

  Neural system · CPC title

• A61B5/7225

  Details of analogue processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation (input circuits for detecting, measuring, or recording bioelectric or biomagnetic signals A61B5/30; specific diagnostic methods using bioelectric or biomagnetic signals A61B5/316) · CPC title

• A61B2018/00267

  having a basket shaped structure · CPC title