Endoscopic sympathectomy systems and methods

• US 9,968,790 B2
• Filed: 05/28/2013
• Issued: 05/15/2018
• Est. Priority Date: 05/29/2012
• Status: Active Grant

• Current Assignee: Autonomix Medical, Inc.
• Original Assignee: Autonomix Medical, Inc.
• Inventors: Toth, Landy, Schwartz, Robert
• Primary Examiner(s): ABOUELELA, MAY A
• Application Number:
  US14/403,891
• Publication Number:
  US 20150224326A1
• Time in Patent Office: 1,813 Days
• Field of Search: 600549, 600546, 128736, 606 46
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• 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 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• 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 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00345 Vascular system
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• 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 2018/143 multiple needles
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/1107 : Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/24 : Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/283 : Invasive
• CPC Class Codes: A61B 5/296 : for electromyography [EMG]
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/4848 : Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4875 : Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/6852 : Catheters
• CPC Class Codes: A61B 7/04 : Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61M 2202/0275 : Nitric oxide [NO]
• CPC Class Codes: A61M 2202/048 : Anaesthetics
• CPC Class Codes: A61M 2202/0484 : Alcohol
• CPC Class Codes: A61M 2202/049 : Toxic
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• 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 1/0553 : Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0556 : Cuff electrodes
• CPC Class Codes: A61N 1/37205 : Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A system for controlled sympathectomy procedures is disclosed. A system for controlled micro ablation procedures is disclosed. Methods for performing a controlled surgical procedure are disclosed. A system for performing controlled surgical procedures in a minimally invasive manner is disclosed. An implantable device for monitoring and/or performing a neuromodulation procedure is disclosed.

Claims

1. A microsurgical tool, comprising:

an endoscopically deliverable elongate structure configured so as to extend from an entry site within a body to a vicinity of an organ; and

at least one sensing tip electrically and mechanically coupled to the elongate structure, the at least one sensing tip being configured;

to interface with tissues in the vicinity of the organ;

to measure local neural activity associated with the tissues in the vicinity of the organ; and

to convey one or more electrophysiological signals associated with an electrophysiological activity;

wherein the at least one sensing tip comprises a clamp structure having an inner surface configured to contact the tissues in the vicinity of the organ and an outer surface opposite the inner surface; and

wherein the at least one sensing tip comprises;

a plurality of electrodes arranged on the inner surface of the clamp, the plurality of electrodes comprising one or more sensing electrodes configured to measure the local neural activity associated with the tissues in the vicinity of the organ; and

one or more additional electrodes arranged on the outer surface of the clamp, the one or more additional electrodes arranged on the outer surface of the clamp being configured to determine a reference signal used by the at least one sensing tip to cancel out ambient environmental action potentials and noise from measurements of the local neural activity by the one or more sensing electrodes on the inner surface of the clamp; and

wherein the clamp structure comprises a self-wrapping tool.

2. The microsurgical tool of claim 1, wherein the electrophysiological signals are related to one or more of a water concentration, a tissue tone, an evoked potential, a remotely stimulated nervous activity, a sympathetic nervous activity, an electromyographic signal [EMG], a mechanomyographic signal [MMG], a local field potential, an electroacoustic event, a vasodilation, a vessel wall stiffness, a muscle sympathetic nerve activity [MSNA], a central sympathetic drive, nerve traffic, or combinations thereof.

3. The microsurgical tool of claim 1, wherein at least one of the plurality of electrodes arranged on the inner surface of the clamp comprises at least one of an embossed, a plated, and a filament loaded structure thereupon.

4. The microsurgical tool of claim 1, wherein the at least one sensing tip is electrically coupled with a microcircuit, the microcircuit configured to condition the one or more electrophysiological signals, and embedded into one of the sensing tip and the elongate structure of the microsurgical tool and at least a portion of the electrical coupling is provided via the elongate structure.

5. The microsurgical tool of claim 1, wherein at least one of the plurality of electrodes arranged on the inner surface of the clamp comprises at least one of one or more needle electrodes and one or more whiskers, each having a characteristic length and a tip and being arranged so as to extend from the sensing tip into the tissues adjacent thereto.

6. The microsurgical tool of claim 5, wherein one or more of the needle electrodes or the whiskers comprise electrical insulation along the length thereof and electrically exposed tips.

7. The microsurgical tool of claim 1, wherein at least one of the plurality of electrodes arranged on the inner surface of the clamp comprises a microelectrode configured to interface with adjacent tissues.

8. The microsurgical tool of claim 7, wherein the microelectrode comprising an area of less than one of 5000 μ

m², 1000 μ

m², 250 μ

m², and 100 μ

m².

9. The microsurgical tool of claim 1, wherein:

the plurality of electrodes arranged on the inner surface of the clamp further comprise a plurality of stimulating electrodes electrically and mechanically coupled to the elongate structure, the plurality of stimulating electrodes configured to provide at least one of a stimulating current and an ablating current to adjacent tissues;

wherein the microsurgical tool is configured to control the at least one current between two or more of the plurality of stimulating electrodes via the adjacent tissues; and

wherein the at least one sensing tip is configured to monitor the effect of the at least one current on the adjacent tissues.

10. The microsurgical tool of claim 9, wherein each of the plurality of stimulating electrodes comprise an area of less than 5000 μ

m² and greater than zero.

11. The microsurgical tool of claim 1, further comprising means for delivering a therapeutic substance to adjacent tissues.

12. The microsurgical tool of claim 11, wherein the at least one sensing tip is configured to monitor the effect of the therapeutic substance on adjacent tissues.

13. The microsurgical tool in accordance with claim 11, wherein the therapeutic substance is selected from one of a chemical, a drug substance, a neuromodulating substance, a neuroblocking substance, an acid, a base, a denervating agent, and a combination thereof.

14. The microsurgical tool of claim 11, wherein the therapeutic substance is selected from one of a neurotoxin, a botulinum toxin, a tetrodotoxin, a tetraethylammonium, a chlorotoxin, a curare, a conotoxin, a bungarotoxin, arsenic, ammonia, ethanol, hexane, nitric oxide, glutamate, resiniferatoxin, alchohol, phenol, capaicin, an anesthetic, lidocaine, tetanus toxin, quaternary ammonium salts, a pachycurare, a leptocurare, acetylcholine, aminosteroids, and a combination thereof.

15. The microsurgical tool of claim 11, wherein the therapeutic substance is comprised within a restraining matrix.

16. The microsurgical tool in accordance with claim 15, wherein the restraining matrix is at least partially biodegradable.

17. The microsurgical tool of claim 1, wherein at least one of the one or more additional electrodes on the outer surface of the clamp is coupled to a reference potential to shield the one or more sensing electrodes on the inner surface of the clamp.

18. The microsurgical tool of claim 1, wherein at least one of the one or more additional electrodes on the outer surface of the clamp is coupled to a reference potential to provide a stable reference against which to measure the local neural activity.

19. The microsurgical tool of claim 1, wherein the clamp structure comprises:

an arm;

a hinge;

a first clamp member having the inner surface and the outer surface; and

a second clamp member having the inner surface and the outer surface;

wherein the hinge couples the arm, the first clamp member and the second clamp member; and

wherein the hinge is configured to open and close the inner surface of the first clamp member and the second clamp member about the tissues in the vicinity of the organ.

20. The microsurgical tool of claim 1, wherein the plurality of electrodes arranged on the inner surface of the clamp further comprise one or more stimulating electrodes configured to apply ablation currents to the tissues in the vicinity of the organ.

21. The microsurgical tool of claim 1, wherein the clamp structure further comprises a local control circuit configured to perform pre-amplification, signal conditioning, radio frequency (RF) signal routing, analog to digital conversion, signal buffering, signal isolation, multiplexing/demultiplexing functions, and communication with externally located hardware.

22. The microsurgical tool of claim 1, wherein the self-wrapping tool comprises one or more actuator layers, each of the one or more actuator layers comprising an active material configured to change shape upon command.

23. The microsurgical tool of claim 22, wherein the active material comprises one or more of a shape memory material, an electroactive polymer and a piezoceramic material.