Systems and methods for trans-esophageal sympathetic ganglion recruitment

Inventors

Bassi, Thiago Gasperini • Hoffer, Joaquin Andres • REYNOLDS, Steven Campbell

Assignees

Lungpacer Medical Inc

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Publication Number

US-11944810-B2

Patent

Publication Date

2024-04-02

Expiration Date


Abstract

A method may include positioning a catheter, including at least one electrode, within an esophagus such that the electrode is proximate to at least one sympathetic ganglion. The methods may further include recruiting the sympathetic ganglion via an electrical signal, monitoring the recruitment of the sympathetic ganglion, and, based on the monitoring the recruitment of the sympathetic ganglion, adjusting the electrical signal from the at least one electrode.

Core Innovation

The invention provides a system using a trans-esophageal esophageal catheter including at least one electrode to induce transmission of a recruiting signal to recruit a sympathetic ganglion. The controller receives a first signal from one or more sensors and induces the electrode to transmit the recruiting signal, where the recruiting signal recruits the sympathetic ganglion.

The recruiting signal is pulsed and has a frequency range of 100 Hz to 100 kHz and an amplitude range of 10 µA to 20 mA, and the controller may adjust the frequency and/or amplitude of the recruiting signal upon receiving a second signal from the one or more sensors or a user. In some configurations, the recruiting signal blocks transmission of nerve signals along the sympathetic ganglion.

The system includes sensor-based monitoring and control, where the controller receives sensor signals and induces the catheter electrodes accordingly, including conditional behavior such as adjusting electrical signal parameters or ceasing transmission. Example sensor inputs include measuring peripheral blood flow and physiological indicators such as palpebral droop, EEG changes, pupil diameter, sclera color change, skin temperature and skin perspiration, and transcranial Doppler ultrasonogram-related blood flow/cerebral perfusion pressure.

In catheter configurations, electrodes may be arranged to recruit selected sides of sympathetic ganglia, such as recruiting a left stellate ganglion using a first electrode in response to a first signal based on left pupil diameter, and recruiting a right stellate ganglion using a second electrode in response to a second signal based on right pupil diameter. The catheter may include a plurality of electrodes and an expandable intermediate section with an inflatable member, where electrodes are positioned at a same axial level, and the intermediate section expands from a contracted state to an expanded state, changing relative electrode spacing.

Claims Coverage

This document presents three independent claims centered on inducing an esophageal-catheter electrode to transmit a pulsed recruiting signal that recruits a sympathetic ganglion, with sensor- and controller-driven control and, in some claims, side-specific targeting and specific catheter and signal characteristics. Across the independent claims, the inventive features include sensor-based controller induction of recruiting signals, pulsed frequency/amplitude ranges, side-specific recruitment based on left/right pupil measurements, and recruiting by blocking sympathetic nerve signal transmission, together with optional catheter structural limitations such as radially expandable intermediate sections and electrode arrangement.

Sensor-based induction of recruiting signal to recruit sympathetic ganglion

The controller receives a first signal from one or more sensors and induces at least one electrode of an esophageal catheter to transmit a recruiting signal that recruits the sympathetic ganglion.

Pulsed recruiting signal with defined frequency and amplitude and controller adjustment

Upon receiving a first signal from the one or more sensors or a user, the controller induces the at least one electrode to transmit a pulsed recruiting signal with a frequency of 100 Hz to 100 kHz and an amplitude of 10 µA to 20 mA, and upon receiving a second signal from the one or more sensors or the user, the controller induces the at least one electrode to adjust the frequency of the recruiting signal, the amplitude of the recruiting signal, or both.

Left/right stellate ganglion recruitment using side-specific pupil sensors and electrode arrangement

An esophageal catheter includes a plurality of electrodes with a first electrode positioned opposite a second electrode at a same axial level, the system includes a first sensor for measuring left pupil diameter and a second sensor for measuring right pupil diameter, and the controller induces the first electrode to transmit a first recruiting signal that recruits a left stellate ganglion upon receiving a first signal based on the left pupil diameter, and induces the second electrode to transmit a second recruiting signal that recruits a right stellate ganglion upon receiving a second signal based on the right pupil diameter.

Overall, claim coverage centers on a controller-driven esophageal catheter electrode system that transmits a pulsed recruiting signal to recruit sympathetic ganglia, with sensor-triggered induction and, in at least one independent claim, explicit recruiting signal frequency and amplitude ranges and controller adjustment based on a second signal. Side-specific recruitment to left and right stellate ganglia is explicitly covered using left/right pupil diameter sensors and corresponding electrode-induced recruiting signals.

Stated Advantages

Potential advantages over invasive needle-based ganglion blocks for treating/moderating brain injury risk associated with SAH/CVS and other neural injuries.

Documented Applications

Treating or moderating brain injury risk associated with SAH/CVS and other neural injuries.

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