Endovascular Nerve Monitoring Devices and Associated Systems and Methods

• US 20170319853A1
• Filed: 05/12/2017
• Published: 11/09/2017
• Est. Priority Date: 11/07/2011
• Status: Abandoned Application

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Yamasaki, Dwayne S., Courtney, Bryan, Li, Wenjeng, Mauch, Kevin, McFarlin, Kevin, Brennan, Gabriel, Gannon, David, Hobbins, David, Kelly, Brian, Nash, Stephen, Bonner, Matthew, Ward, Sean
• Application Number:
  US15/594,102
• Publication Number:
  US 20170319853A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00261 arranged in a line
• 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 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6856 with a distal loop
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 : Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 1/36125 : Details of circuitry or electric components
• CPC Class Codes: A61N 1/36171 : Frequency
• CPC Class Codes: A61N 1/36175 : Pulse width or duty cycle

Abstract

Endovascular nerve monitoring devices and associated systems and methods are disclosed herein. A nerve monitoring system configured in accordance with a particular embodiment of the present technology can include a shaft having a proximal portion and a distal portion and a nerve monitoring assembly at the distal portion. The shaft is configured to locate the distal portion intravascularly at a treatment site. The nerve monitoring assembly can include a bipolar stimulation electrode array and a bipolar recording electrode array disposed distal to the bipolar stimulation electrode assembly.

Claims

1-27. -27. (canceled)

28. A system, comprising:

a shaft including a proximal portion and a distal portion, wherein the shaft is configured to intravascularly locate the distal portion at a treatment site within a renal blood vessel of a human patient;

a balloon at the distal portion of the shaft, wherein the balloon is transformable between a delivery state and a deployed state, and wherein, in the deployed state, the balloon is configured to provide non-target tissue with protection from neuromodulation;

a lumen extending distally from a proximal portion of the shaft to an opening positioned along a portion of the shaft within the balloon;

a first electrode positioned on the outer surface of the balloon and extending about at least a portion of the circumference of the balloon;

a second electrode positioned on the outer surface of the balloon and extending about at least a portion of the circumference of the balloon, wherein the first electrode is spaced apart from and electrically isolated from the second electrode along the balloon;

wherein, in the deployed state, the balloon is sized and shaped to place the first electrode and the second electrode in apposition with an inner wall of the renal blood vessel; and

wherein the first and second electrodes are configured to—

deliver therapeutic neuromodulation to renal nerves proximate the treatment site, and

stimulate nerves and/or record nerve activity at the treatment site.

29. The system of claim 28 wherein the first electrode is configured to stimulate renal nerves proximate the treatment site and the second electrode is configured to record nerve activity at the treatment site during and/or after the therapeutic neuromodulation.

30. The system of claim 29 wherein the second electrode is configured to record nerve signals less than 1.5 pV.

31. The system of claim 28, further comprising an insulated portion between the first electrode and the second electrode on the outer surface of the balloon.

32. The system of claim 28 wherein:

the first electrode comprises a conductive strip configured for monopolar stimulation; and

the second electrode comprises two conductive strips configured for bipolar recording of renal nerve activity before, during, and/or after therapy.

33. The system of claim 28 wherein the lumen is a first lumen, and wherein the shaft further includes a second lumen extending distally to a second opening positioned along a portion of the shaft within the balloon.

34. The system of claim 28 wherein at least one of the first and second electrodes includes a multi-electrode loop having at least two electrodes spaced circumferentially about the loop.

35. The system of claim 28 wherein at least one of the first electrode and the second electrode is configured to deliver radio frequency (RF) energy sufficient to ablate the renal nerves proximate the treatment site.

36. The system of claim 28 wherein the balloon, in the deployed state, is sized and shaped to occlude the renal blood vessel.

37. A system, comprising:

a shaft including a proximal portion and a distal portion, wherein the shaft is configured to intravascularly locate the distal portion at a treatment site within a renal blood vessel of a human patient;

an outer balloon at the distal portion of the shaft, wherein the outer balloon is transformable between a first delivery state and a first deployed state, and wherein, in the first deployed state, the outer balloon is configured to provide non-target tissue with protection from neuromodulation;

an inner balloon positioned within the outer balloon, wherein the inner balloon is transformable between a second delivery state and a second deployed state, and wherein, in the second deployed state, the inner balloon is configured to provide therapeutic neuromodulation to nerves proximate the treatment site;

a first electrode positioned on the outer surface of the outer balloon and extending about at least a portion of the circumference of the outer balloon; and

a second electrode positioned on the outer surface of the outer balloon and extending about at least a portion of the circumference of the outer balloon,

wherein the first electrode is spaced apart from and electrically isolated from the second electrode along the outer balloon,

wherein the first and second electrodes are configured to stimulate nerves and/or record nerve activity at the treatment site.

38. The system of claim 37 wherein the inner balloon, when in the second deployed state, is positioned between the first electrode and the second electrode.

39. The system of claim 37 wherein the outer balloon is configured to receive an insulating inflation medium and the inner balloon is configured to receive a thermal fluid.

40. The system of claim 37 wherein:

the outer balloon is configured to receive an insulating inflation medium via a first lumen extending distally from a proximal portion of the shaft to a first opening positioned along a portion of the shaft within the outer balloon; and

the inner balloon is configured to receive a thermal fluid via a second lumen extending distally from a proximal portion of the shaft to a second opening positioned along a portion of the shaft within the inner balloon.

41. The system of claim 37 wherein the outer balloon, in the first deployed state, is sized and shaped to occlude the renal blood vessel.

42. The system of claim 37 wherein the inner balloon, in the second deployed state, is sized and shaped to contact the outer balloon at an interface extending around a full circumference of the inner balloon.

43. The system of claim 37 wherein the inner balloon has a smaller diameter in the second deployed state than the diameter of the outer balloon in the first deployed state.

44. The system of claim 43 wherein the inner balloon is attached to an interior surface of the outer balloon.

45. The system of claim 37 wherein the first and second electrodes are configured to monitor the strength of the nerve signal before, during, and/or after neuromodulation.

46. The system of claim 37 wherein the first electrode is one of a plurality of point electrodes and/or the second electrode is one of a plurality of point electrodes.

47. The system of claim 46 wherein the plurality of point electrodes are configured to provide monopolar and/or bipolar nerve stimulation and recording at the treatment site.