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Publication Number

US-11510731-B2

Patent

Publication Date

2022-11-29

Expiration Date


Abstract

Systems and methods provide interface to a patient's autonomic nerves via an interior lumen wall of a blood vessel. Systems can include a probe having at least one electrode for receiving electrical signals from the interior of the lumen wall. The system can include processing components for extracting the signals from noise within the patient's body. Systems can include stimulation electrodes for providing stimulation and eliciting action potentials within the patient and destructive processes for destroying nervous function. The effect of nerve destruction on the propagation of action potentials can be effectively used as a feedback mechanism for determining the amount of nervous function destruction in the patient.

Core Innovation

The invention provides a nerve-probe system for interfacing with autonomic nerves. A probe carrying stimulation electrodes and recording electrodes is positioned against a blood vessel interior lumen wall so that stimulation is applied to a first blood vessel tissue surface proximate the stimulation electrodes. The system evokes elicited response potentials in nerves and detects propagated elicited response potentials at a second blood vessel tissue surface beyond the nerve.

The electronic control unit receives and processes signals that include the elicited response potential detected by the recording electrodes. The processing extracts neural activity from EMG and noise by using filtering, amplification, and averaging, and by applying an optional blanking function and/or temporal window selection. The system uses comparison between baseline elicited potentials and elicited potentials measured after a nerve destruction process to quantify the extent of nerve destruction and to evaluate whether additional ablation is needed.

The probe and electrode arrangement includes a first portion and a second portion coupled for translation so that the distance between a first set of electrodes and a second set of electrodes is user-adjustable. Adjusting this longitudinal spacing creates a temporal window in which the elicited response potential is predicted to arrive at the second set of electrodes after application of the stimulation pulse. The electronic control unit inhibits receipt of noise or other artifacts not associated with the elicited response potential by processing only during the temporal window after the stimulation pulse.

Claims Coverage

The independent claim (clm-00001) covers a medical apparatus with four inventive features: a two-part, longitudinally translatable electrode probe, stimulation at a blood-vessel tissue surface, detection of an elicited response potential at a downstream blood-vessel tissue surface beyond a nerve, and electronic control that uses a user-adjustable temporal window to inhibit noise and artifacts. The claim set further narrows or refines the apparatus with additional electrode-contact or electrode-functional features.

Temporal window created by user-adjustable electrode translation

A distance between a first set of electrodes and a second set of electrodes is user-adjustable by translating a second portion longitudinally relative to a first portion to space the first set from the second set at a distance that creates a temporal window in which the elicited response potential can be predicted to arrive at the second set after application of the stimulation pulse.

Noise/artifact inhibition by temporal-window processing

The electronic control unit is configured to receive and process a signal including the elicited response potential detected by the second set during the temporal window after application of the stimulation pulse to inhibit the apparatus from receiving noise or other artifacts not associated with the elicited response potential.

Stimulation and elicited-response detection across a nerve

At least one electrode of the first set is configured to receive a stimulation pulse from the electronic control unit and apply the stimulation pulse to a first blood vessel tissue surface proximate the first set of electrodes, and the second set is configured to detect an elicited response potential at a second blood vessel tissue surface proximate a nerve beyond the second blood vessel tissue surface.

Two-part probe with longitudinal translation relative positioning

A probe includes a first portion and a second portion, where the first portion and the second portion are sized and shaped to at least partially insert into a blood vessel, the second portion is coupled to the first portion and configured to translate to be positioned longitudinally relative to the first portion, and the first and second electrode sets are respectively disposed on the first and second portions.

Across the independent claim and its refinements, the central coverage is the combination of stimulation applied at a first blood-vessel tissue surface via a first electrode set, detection of an elicited response potential at a second blood-vessel tissue surface beyond a nerve via a second electrode set, user-adjustable longitudinal translation that creates a temporal prediction window for the response arrival, and electronic-control signal processing during that window to inhibit noise and artifacts not associated with the elicited response potential.

Stated Advantages

Inhibits receipt of noise or other artifacts not associated with the elicited response potential by processing the detected signal during the temporal window.

Documented Applications

Diagnostic use based on baseline measurement and elicited potentials measured after a nerve destruction process to quantify the extent of nerve destruction.

Use in connection with nerve destruction processes where comparison of elicited potential reduction is used to evaluate extent of nerve destruction and whether additional ablation is needed.

Autonomic nerve assessment using a nerve-probe system positioned against a blood vessel interior lumen wall.

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