Systems and methods for neurological traffic and/or receptor functional evaluation and/or modification

• US 10,004,458 B2
• Filed: 03/27/2014
• Issued: 06/26/2018
• Est. Priority Date: 03/27/2013
• Status: Active Grant

• Current Assignee: Autonomix Medical, Inc.
• Original Assignee: Autonomix Medical, Inc.
• Inventors: Toth, Landy, Schwartz, Robert
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): KUO, JONATHAN T
• Application Number:
  US14/780,068
• Publication Number:
  US 20160029960A1
• Time in Patent Office: 1,552 Days
• Field of Search: 600372-397
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• 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 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/0088 Vibration
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• 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 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36139 : with automatic adjustment

Abstract

Systems and methods for controlled sympathectomy procedures for neuromodulation are disclosed. A system for controlled micro ablation procedures is disclosed. A guidewire including one or more sensors or electrodes for accessing and recording physiologic information from one or more anatomical sites within the parenchyma of an organ as part of a physiologic monitoring session, a diagnostic test, or a neuromodulation procedure is disclosed. A guidewire including one or more sensors and/or a means for energy delivery, for performing a neuromodulation procedure within a small vessel within a body is disclosed.

Claims

1. A guidewire, comprising:

an elongate body dimensioned for insertion into a lumen within a body; and

a sensing tip electrically and mechanically coupled to the elongate body, configured to interface with the wall of the lumen, the sensing tip configured to convey one or more electrophysiological signals associated with an electrophysiological activity in the vicinity of an anatomical site of interest within the vicinity of the lumen;

wherein the guidewire is configured to monitor the electrophysiological activity;

wherein the sensing tip comprises;

a flexible substrate dimensioned to form a base and two or more tines extending from the base;

a plurality of electrodes formed on the two or more tines of the flexible substrate;

one or more microcircuits formed on the base of the flexible substrate;

one or more conducting traces formed on the flexible substrate providing electrical interconnection between the one or more microcircuits and the plurality of electrodes; and

one or more interconnects for coupling at least one of the one or more microcircuits formed on the base of the flexible substrate with one or more power and signal lead wires; and

wherein the flexible substrate is rolled to form the sensing tip.

2. The guidewire in accordance with claim 1, wherein the plurality of electrodes are dimensioned and configured to interface with the anatomical site of interest upon placement thereby.

3. The guidewire in accordance with claim 1, wherein the plurality of electrodes are configured to measure one or more electrophysiological signals related to one or more of water concentration, tone, evoked potential, remote stimulation of nervous activity, an electromyographic signal, a mechanomyographic signal, a local field potential, an electroacoustic event, vasodilation, vessel wall stiffness, muscle sympathetic nerve activity, central sympathetic drive, tissue tone, nerve traffic, or combinations thereof.

4. The guidewire in accordance with claim 1, wherein the sensing tip is dimensioned and configured for placement into a parenchyma of an organ coupled with the lumen.

5. The guidewire in accordance with claim 4, wherein the sensing tip is dimensioned and configured for placement into at least one of a renal cortex of a kidney, an adrenal gland, an adrenal medulla, an adrenal cortex, and a renal pelvis of a kidney.

6. The guidewire in accordance with claim 1, wherein the sensing tip is configured such that at least one of the plurality of electrodes comprised therein is substantially isolated from a fluid within the lumen upon deployment of the sensing tip within the lumen by an isolation layer selectively applied to one or more regions of the sensing tip.

7. The guidewire in accordance with claim 1, wherein the sensing tip is configured such that at least one of the plurality of electrodes comprised therein maintains contact with a wall of the lumen during a procedure upon deployment of the sensing tip within the lumen.

8. The guidewire in accordance with claim 1, wherein at least one of the plurality of electrodes substantially maintains contact with the wall of the lumen while the sensing tip is dragged along the interior thereof, after deployment of the sensing tip within the lumen.

9. The guidewire in accordance with claim 1, wherein the sensing tip is configured such that at least one of the plurality of electrodes is embedded into a wall of the lumen upon deployment of the sensing tip within the lumen.

10. The guidewire in accordance with claim 1, wherein the guidewire is coupled to a second surgical device, the second surgical device configured to perform at least one of an ablation procedure and a stimulation procedure within the body.

11. The guidewire in accordance with claim 10, wherein the second surgical device provides a reference electrode electrically coupled with at least one of the plurality of electrodes comprised within the guidewire.

12. The guidewire in accordance with claim 1, wherein at least one of the microcircuits is configured to convey one or more sensed physiologic signals to a proximal end of the guidewire via the one or more power and signal lead wires.

13. The guidewire in accordance with claim 12, wherein at least one of the microcircuits is configured to condition one or more of the sensed physiologic signals measured by one or more of the plurality of electrodes prior to conveying the one or more sensed physiologic signals to the proximal end of the guidewire.

14. The guidewire in accordance with claim 12, wherein at least one of the microcircuits is configured to perform a digital conversion of one or more of the sensed physiologic signals measured by one or more of the plurality of electrodes prior to conveying the one or more sensed physiologic signals to the proximal end of the guidewire.

15. The guidewire in accordance with claim 12, wherein at least one of the microcircuits is configured to multiplex sensed physiologic signals from two or more of the plurality of electrodes comprised within the guidewire prior to conveying the sensed physiologic signals to the proximal end of the guidewire.

16. The guidewire in accordance with claim 1, wherein the guidewire further comprises one or more additional electrodes electrically and mechanically coupled with the elongate body, configured to deliver energy to the anatomical site of interest upon placement thereby.

17. The guidewire in accordance with claim 1, wherein the guidewire comprises one or more microneedles slidingly coupled with the elongate body, configured so as to be deployed beyond the elongate body into the anatomical site of interest upon placement thereby.

18. The guidewire in accordance with claim 17, wherein at least one of the one or more microneedles comprises a lumen through which a substance may be delivered to the anatomical site of interest upon deployment of the microneedle there into.

19. The guidewire in accordance with claim 18, wherein the substance is one of a neurotoxin, a cancer treating agent, a neuroblocking agent, a neurostimulating agent, a neurodepressant, a vasodilator, a vasoconstrictor, glucose, insulin, a combination thereof, and a formulation of the substance with a delivery vehicle.

20. The guidewire in accordance with claim 18, wherein at least one of the one or more microneedles comprises one or more electrodes for at least one of sensing, stimulating, and ablating the anatomical site of interest upon deployment of the microneedle there into.

21. The guidewire of claim 1, wherein the guidewire comprises a diameter one of less than 1 mm, less than 0.75 mm, less than 0.5 mm, and less than 0.25 mm.

22. A system for neuromodulating an anatomical site in a vicinity of a lumen, comprising:

a subsystem configured to perform a surgical procedure on the anatomical site;

a guidewire configured to monitor electrophysiological activity within a parenchyma of an organ coupled to the lumen and to generate one or more signals therefrom; and

a control unit configured to accept signals from the guidewire, and to at least one of;

adjust the surgical procedure dependent upon the signals;

display the signals;

evaluate the surgical procedure dependent upon the signals;

plan a surgical path dependent upon the signals; and

determine the extent of the procedure dependent upon the signals;

wherein the guidewire comprises;

an elongate body dimensioned for insertion into a lumen within a body; and

a sensing tip electrically and mechanically coupled to the elongate body, configured to interface with the wall of the lumen, the sensing tip configured to convey one or more electrophysiological signals associated with an electrophysiological activity in the vicinity of an anatomical site of interest within the vicinity of the lumen;

wherein the sensing tip comprises;

a flexible substrate dimensioned to form a base and two or more tines extending from the base;

a plurality of electrodes formed on the two or more tines of the flexible substrate;

one or more microcircuits formed on the base of the flexible substrate;

one or more conducting traces formed on the flexible substrate providing electrical interconnection between the one or more microcircuits and the plurality of electrodes; and

one or more interconnects for coupling at least one of the one or more microcircuits formed on the base of the flexible substrate with one or more power and signal lead wires; and

wherein the flexible substrate is rolled to form the sensing tip.

23. The system in accordance with claim 22, wherein the surgical procedure is selected from the group consisting of an ablation, an excision, a cut, a burn, a radio frequency ablation, radiosurgery, an ultrasonic ablation, an abrasion, a biopsy, and delivery of a substance.

24. The system in accordance with claim 22, further comprising at least one of a stimulation electrode and an ablation electrode configured so as to convey at least one of a pulsatile frequency signal and a radio frequency signal to the anatomical site from the control unit, the guidewire configured to convey one or more feedback signals related to at least one of the pulsatile frequency signal and radio frequency signal back to the control unit.

25. The system in accordance with claim 24, wherein the one or more feedback signals are related to an electrode impedance, a bioimpedance, a local electrical field, or an electrophysiological response to at least one of the pulsatile frequency signal and radio frequency signal.

26. The system in accordance with claim 24, wherein at least one of the stimulation electrode and ablation electrode is comprised within the guidewire.

27. The system in accordance with claim 26, wherein at least one of the stimulation electrode and ablation electrode is comprised within the sensing tip of the guidewire.

28. The system in accordance with claim 22, wherein the subsystem is situated coaxially with the guidewire in the lumen.

29. The system in accordance with claim 22, further comprising a sensor, separate from the sensing tip, configured to measure one or more physiologic signals associated with a body comprising the lumen, and to convey the physiologic signals to the control unit for use in the procedure.

30. The system in accordance with claim 29, wherein the sensor is configured to measure one or more of water concentration, tone, blood oxygen saturation of local tissues, evoked potential, stimulation of nervous activity, sensing of nervous activity, electromyography, temperature, blood pressure, vasodilation, vessel wall stiffness, muscle sympathetic nerve activity (MSNA), central sympathetic drive, tissue tone, blood flow, a blood flow differential signal, blood perfusion, pupil dilation, electrolyte levels in a biofluid, a blood analyte level, nerve traffic, or a combination thereof.

31. The system of claim 22, wherein the subsystem is provided over the guidewire to perform the surgical procedure on the anatomical site.