US-20260123986-A1 - SYSTEMS, METHODS, AND DEVICES FOR MONITORING AND TREATMENT OF TISSUES WITHIN AND/OR THROUGH A LUMEN WALL

US20260123986A1US 20260123986 A1US20260123986 A1US 20260123986A1US-20260123986-A1

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. Systems and methods for accessing target tissues as part of a neuromodulation procedure from within a lumen are disclosed.

Inventors

Landy Toth
Roy Martin

Assignees

AUTONOMIX MEDICAL, INC.

Dates

Publication Date: 20260507
Application Date: 20260102

Claims (20)

1 . A tool comprising: an elongate member comprising a distal tip and a control end, the elongate member configured to extend from an entry site on a body into a lumen within the body; one or more stabilizing members coupled to the elongate member, the one or more stabilizing members being configured to deploy from the distal tip of the elongate member and to retain a position of the distal tip within a lumen; and one or more probes coupled with at least one of the distal tip of the elongate member and at least one of the one or more stabilizing members, the one or more probes being configured for deployment responsive to actuation at the control end; wherein a given one of the probes comprises a probe tip configured to penetrate at least one of into and through the wall of the lumen upon deployment of the given probe; and wherein the given probe comprises one or more electrodes configured to at least one of monitor and alter electrophysiological activity in the vicinity of the lumen.
2 . The tool of claim 1 , wherein the electrophysiological activity comprises electrophysiological signals related to one or more of water concentration, tissue tone, evoked potential, remotely stimulated nervous activity, sympathetic nervous activity, an electromyographic signal [EMG], a mechanomyographic signal [MMG], a local field potential, an electroacoustic event, vasodilation, vessel wall stiffness, muscle sympathetic nerve activity [MSNA], central sympathetic drive, nerve traffic, or combinations thereof.
3 . The tool of claim 1 , further comprising a microcircuit embedded in the elongate member and coupled to the one or more electrodes of the given probe tip, the microcircuit configured to condition one or more signals conveyed from the one or more electrodes to the control end of the elongate member.
4 . The tool of claim 1 , wherein the one or more electrodes comprise one or more stimulating electrodes configured to provide at least one of a stimulating and ablating current to a tissue site in the vicinity of the wall of the lumen.
5 . The tool of claim 1 , wherein the given probe comprises a channel fluidly coupled with the control end of the elongate member, the channel configured to deliver at least one of a diagnostic and therapeutic substance to a tissue site in the vicinity of the wall of the lumen.
6 . The tool of claim 1 , wherein the given probe comprises a stabilizing element positioned at a predetermined distance from the tip of the given probe, the stabilizing element configured to limit a depth that the given probe penetrates into the wall of the lumen upon deployment from the elongate member.
7 . The tool of claim 1 , wherein the given probe comprises an anchor for securing the given probe to the wall of the lumen upon deployment of the given probe from the elongate member.
8 . The tool of claim 1 , wherein the one or more stabilizing members comprise a plurality of wire members.
9 . The tool of claim 8 , wherein the plurality of wire members have blunt tips, the plurality of wire members being configured to curl outwardly upon deployment from the distal tip of the elongate member to bias against the wall of the lumen without puncturing the wall of the lumen.
10 . The tool of claim 8 , wherein the plurality of wire members comprises a basket catheter.
11 . The tool of claim 10 , further comprising a guiding lumen at the distal tip of the elongate member and a distal portion of the basket catheter.
12 . The tool of claim 11 , further comprising a guidewire configured for advancement and retraction through the guiding lumen.
13 . The tool of claim 8 , wherein the given probe is configured for deployment from a given one of the plurality of wire members.
14 . The tool of claim 13 , wherein the given wire member comprises a channel for communication of a fluid to the probe tip of the given probe.
15 . The tool of claim 1 , wherein the given probe is configured for deployment from the elongate member.
16 . The tool of claim 1 , further comprising one or more additional electrodes arranged on at least one of the one or more stabilizing members, the one or more additional electrodes being configured to at least one of monitor and alter electrophysiological activity in the vicinity of the lumen.
17 . A system comprising: a tool comprising an elongate member, one or more stabilizing elements coupled to the elongate member, and one or more probes coupled to at least one of a distal tip of the elongate member and at least one of the one or more stabilizing members, the one or more probes being configured for deployment responsive to actuation at a control end of the elongate member, a given one of the probes comprising a probe tip configured to penetrate at least one of into and through a wall of the lumen upon deployment of the given probe, the given probe comprising one or more electrodes; and a control unit configured to exchange signaling with the control end of the elongate member to direct the one or more electrodes of the given probe to at least one of monitor and alter electrophysiological activity in the vicinity of the lumen.
18 . The system of claim 17 , wherein the control unit is configured to utilizing signaling from the control end of the elongate member to at least one of: adjust a surgical procedure; evaluate the surgical procedure; plan a surgical path for the surgical procedure; and determine an extent of the surgical procedure.
19 . The system of claim 17 , wherein the one or more electrodes of the given probe comprise one or more sensing electrodes and one or more stimulating electrodes, and wherein the control unit is configured: to provide signaling to the control end of the elongate member to convey at least one of a pulsatile and a radio frequency signal to an anatomical site via the one or more stimulating electrodes; and to receive signaling from the control end of elongate member comprising feedback related to the at least one pulsatile and radio frequency signal measured by the one or more sensing electrodes.
20 . The system of claim 17 , wherein the control unit is configured to utilize signaling received from the one or more electrodes via the control end of the elongate member to locate an anatomical site with respect to a position of the tool.

Description

CROSS-REFERENCE TO RELATED APPLICATION The present application is a continuation of U.S. patent application Ser. No. 18/656,031, filed May 6, 2024, which is a continuation of U.S. application Ser. No. 17/136,316, filed on Dec. 29, 2020, which is a continuation of U.S. application Ser. No. 15/906,127, filed on Feb. 27, 2018, which is a continuation of U.S. application Ser. No. 14/439,989 filed on Apr. 30, 2015, which is a national stage application of International Application No. PCT/US2013/067726 which claims benefit of and priority to U.S. Provisional Application Ser. No. 61/722,264 filed on Nov. 5, 2012, entitled “Systems and Methods for Treatment of and/or Through a Lumen Wall”, by Landy Toth et al., the entire contents of which are incorporated by reference herein for all purposes. BACKGROUND Technical Field The present disclosure relates to the field of monitoring and/or surgical modification of neurological and/or receptor functionality and activity. The present disclosure also relates to catheter based systems for use in nerve and/or receptor monitoring, electrophysiological monitoring, and/or surgical procedures. Background Congestive heart failure, hypertension, diabetes, sleep apnea, and chronic renal failure have many different initial causes; however, all may include some form of sympathetic hyperactivity. Sensory receptors and sympathetic nerves communicate signals with sympathetic centers located in the spinal cord and brain via afferent renal nerve activity, increasing systemic sympathetic tone; meanwhile, through efferent activity, renal nerves and arteries participate in sympathetic hyperactivity in response to signals from the brain, further increasing systemic sympathetic tone. Sympathetic activation can initially be beneficial but eventually becomes maladaptive. In a state of sympathetic hyperactivity, a number of pathological events take place: abnormalities of hormonal secretion such as increased catecholamine, renine and angiotensin II levels, increased blood pressure due to peripheral vascular constriction and/or water and sodium retention, renal failure due to impaired glomerular filtration and nephron loss, cardiac dysfunction and heart failure due to left ventricular hypertrophy and myocyte loss, stroke, and even diabetes. Therefore, modulation (reduction/removal) of this increased sympathetic activity can slow or prevent the progression of these diseases. Although ablation of such nerves can have positive effects on drug resistant hypertension and glucose metabolism abnormality, current methodologies for denervation (e.g. ablation, etc.) are conducted without adequate feedback (with respect to the site of a denervation event, the extent of denervation, the effect of denervation on local physiology, etc.). Furthermore, many conditions require access to tissues within the walls of a lumen within the body. Oftentimes, access to deeper tissues within the wall may be necessary for optimal treatment. Inner layers of tissue and damage adjacent to the lumen (e.g. intima, plaque, calcium deposits, etc.) may present complications in communicating from within the lumen out into the wall thereof to the desired tissues (e.g. electrical communication, fluid communication, and the like). SUMMARY One objective of this disclosure is to provide systems, devices, and methods for accessing, monitoring and/or treating a surgical site and/or tissue within a body. Another objective is to provide systems, devices, and methods for locating, monitoring, and/or mapping electrophysiological function of one or more surgical sites before, during, and/or following a stimulus and/or a surgical procedure. Another objective is to provide systems, devices, and methods to modify electrophysiological function of an organ, to modulate intra organ neurological traffic, and/or to modulate nervous activity (e.g. sympathetic, parasympathetic, autonomous, enteric, etc.), in a volume of tissue, and/or a surgical site, via a surgical process. Yet another objective is to provide systems, devices, and methods for monitoring and/or altering electrophysiological activity of a volume of tissue, a surgical site, a region within an organ as part of a surgical procedure, a diagnostic procedure, and/or as part of a chronic monitoring system. Another objective is to provide, systems, devices, and methods for interfacing with the tissues of the wall of a lumen as well as tissues exterior to the lumen, via intra lumen access (e.g. via minimally invasive procedure, via catheter access, etc.). The above objectives are wholly or partially met by devices, systems, and methods according to the appended claims in accordance with the present disclosure. Features and aspects are set forth in the appended claims, in the following description, and in the annexed drawings in accordance with the present disclosure. According to a first aspect there is provided, a microsurgical tool for monitoring and/or altering electrophysiological activity with