Cardiac pacing sensing and control

Inventors

Sanghera, Rick • Marcovecchio, Alan • McGeehan, Sean P.

Assignees

Atacor Medical Inc

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Publication Number

US-12296175-B2

Patent

Publication Date

2025-05-13

Expiration Date


Abstract

A cardiac pacing system having a pulse generator for generating therapeutic electric pulses, a lead electrically coupled with the pulse generator having an electrode, a first sensor configured to monitor a physiological characteristic of a patient, a second sensor configured to monitor a second physiological characteristic of a patient and a controller. The controller can determine a pacing vector based on variables including a signal received from the second sensor, and cause the pulse generator to deliver the therapeutic electrical pulses according to the determined pacing vector. The controller can also modify pacing characteristics based on variables including a signal received from the second sensor.

Core Innovation

The disclosure describes an implantable cardiac pacing system in which a pulse generator generates therapeutic electric pulses to a heart of a patient and delivers the pulses to the heart via at least one lead implanted within a mediastinum of the patient in a location not in the heart. The lead includes an electrode, and the pulse generator includes a housing. A controller uses sensor signals to determine how the therapeutic electric pulses are delivered to the heart.

A first sensor monitors a first physiological characteristic of the patient, and the controller determines a vector based on variables that include a signal received from the first sensor. The variables include at least one of a sensed amount of skeletal muscle stimulation during pacing, a sensed posture of the patient, or an analyzed breathing pattern of the patient. The controller causes the pulse generator to deliver the therapeutic electrical pulses according to the determined vector and, in one aspect, modifies delivery to maintain cardiac capture based on the breathing pattern.

The controller further uses additional variable inputs to adjust or confirm therapeutic delivery, including variables such as patient perception of discomfort, energy required for candidate pacing vectors, and electrode-to-sensor distance. The disclosure also includes delivery-vector switching and multi-electrode cathode/anode configurations, where electrodes are used for sensing and delivery and vector selection assessment considers patient perception of discomfort. In some aspects, the system modifies delivery characteristics including pacing vector, pulse energy, and pulse width based on sensor-derived variables.

Claims Coverage

The provided material contains four independent claims (clm-00001, clm-00013, clm-00031, clm-00037). Across these claims, the inventive coverage centers on an implantable mediastinum lead cardiac pacing system with sensor-based determination of a pacing/stimulation vector and, in certain claims, breathing-pattern modification to maintain cardiac capture and the incorporation of patient-perceived discomfort into a vector selection assessment.

Therapeutic pulse delivery via mediastinum-implanted lead with electrode

A pulse generator generates therapeutic electric pulses to a heart of a patient, and an at least one lead has a distal end implanted within a mediastinum of the patient in a location not in the heart, the at least one lead including an electrode.

Vector determination from sensor signals including skeletal muscle stimulation

A controller determines a vector based on variables including a signal received from the first sensor, wherein the variables include a sensed amount of skeletal muscle stimulation during pacing, and the controller causes the pulse generator to deliver the therapeutic electrical pulses according to the determined vector.

Breathing-pattern analysis to modify delivery for cardiac capture

A controller analyzes a breathing pattern of the patient, modifies the delivery of the therapeutic electrical pulses based on the breathing pattern to maintain cardiac capture, modifies delivery characteristics based on variables including a signal received from the first sensor, and causes the pulse generator to deliver the therapeutic electrical pulses according to the determined modified delivery characteristics.

Vector determination using sensed posture

A controller determines a vector based on variables including a signal received from the first sensor, wherein the variables include a sensed posture of the patient, and the controller causes the pulse generator to deliver the therapeutic electrical pulses according to the determined vector.

Vector selection assessment considering patient perception of discomfort

A controller determines a vector based on variables including a signal received from the first sensor, performs a vector selection assessment wherein a patient perception of discomfort is considered and determining the vector is based on results of the vector selection assessment, and causes the pulse generator to deliver the therapeutic electrical pulses according to the determined vector.

Overall, the independent claims require an implantable cardiac therapeutic pulse delivery system using a lead implanted in the mediastinum (not in the heart) and a controller that determines a vector for delivering therapeutic pulses using sensor-derived variables. Claim coverage further includes breathing-pattern-based modification to maintain cardiac capture and, in one claim, a vector selection assessment that explicitly considers patient perception of discomfort.

Stated Advantages

Maintain cardiac capture by modifying delivery based on a breathing pattern.

Documented Applications

Cardiac pacing or cardiac therapeutic stimulation of a patient’s heart using an implantable pulse generator and a lead implanted within a mediastinum (not in the heart).

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