Methods and systems for lowering blood pressure through reduction of ventricle filling

Inventors

Mika, Yuval • Sherman, Darren • Schwartz, Robert S. • Van Tassel, Robert A. • Burkhoff, Daniel

Assignees

BackBeat Medical LLC

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Publication Number

US-11986661-B2

Patent

Publication Date

2024-05-21

Expiration Date


Abstract

Methods and devices for reducing ventricle filling volume are disclosed. In some embodiments, an electrical stimulator may be used to stimulate a patient's heart to reduce ventricle filling volume or even blood pressure. When the heart is stimulated in a consistent way to reduce blood pressure, the cardiovascular system may over time adapt to the stimulation and revert back to the higher blood pressure. In some embodiments, the stimulation pattern may be configured to be inconsistent such that the adaptation response of the heart is reduced or even prevented. In some embodiments, an electrical stimulator may be used to stimulate a patient's heart to cause at least a portion of an atrial contraction to occur while the atrioventricular valve is closed. Such an atrial contraction may deposit less blood into the corresponding ventricle than when the atrioventricular valve is opened throughout an atrial contraction.

Core Innovation

The invention relates to electrical cardiac stimulation to reduce blood pressure in a patient. A first stimulation electrode stimulates an atrium, while a second stimulation electrode stimulates a first ventricle and a third stimulation electrode stimulates a second ventricle. At least one controller executes a stimulation pattern comprising at least one stimulation pulse with at least one stimulation setting that reduces or prevents atrial kick in the first ventricle and/or the second ventricle.

The stimulation setting prevents at least one atrial contraction of the heart, thereby reducing ventricular filling associated with atrial kick. The disclosure includes stimulation strategies intended to affect cardiovascular adaptation and spike behavior, including different atrioventricular delay values and different baroreflex-modulating settings. The controller can adjust the stimulation pattern to limit adaptation by making stimulation patterns inconsistent.

The disclosure includes system embodiments with optional sensors and controller-based adjustment of stimulation parameters. Sensors may include a blood pressure sensor, a blood flow sensor, and a heart sound sensor and/or ultrasound/echocardiography Doppler for atrioventricular valve status. The controller can execute closed-loop operation by adjusting the stimulation pattern based on received patient blood pressure information and/or valve-status-related information, and can use timing strategies based on sensed atrial excitation.

Claims Coverage

The independent claims cover a blood-pressure-reducing cardiac stimulation system and methods that use atrial and biventricular stimulation to reduce or prevent atrial kick by preventing atrial contraction. Across the independent claims, the main inventive features include multi-electrode atrial/ventricular stimulation with a controller-executed stimulation pattern and closed-loop pattern adjustment based on blood pressure variation parameters.

Atrial and biventricular stimulation pattern preventing atrial kick

A first stimulation electrode for stimulating an atrium; a second stimulation electrode for stimulating a first ventricle and a third stimulation electrode for stimulating a second ventricle; and at least one controller that executes a stimulation pattern comprising at least one stimulation pulse having at least one stimulation setting that reduces or prevents atrial kick in the first ventricle and/or the second ventricle, wherein the at least one stimulation setting prevents at least one atrial contraction of the heart.

Electrode-based atrial and biventricular stimulation to prevent atrial contraction

Stimulating a heart of a patient through a first stimulation electrode in electrical communication with an atrium; through a second stimulation electrode in electrical communication with a first ventricle; and a third stimulation electrode in electrical communication with a second ventricle, and executing the stimulation using at least one controller, the stimulation providing a stimulation pattern comprising at least one stimulation pulse having at least one stimulation setting that reduces or prevents atrial kick in the first ventricle and/or the second ventricle, wherein the at least one stimulation setting prevents at least one atrial contraction of the heart.

Closed-loop stimulation pattern adjustment using blood pressure variation

Providing a first stimulation pattern comprising at least one stimulation setting configured to reduce or prevent atrial kick in at least one ventricle for a first time interval; receiving a first input data set relating to a patient's blood pressure during the first time interval; calculating at least one blood pressure variation parameter relating to the first input data set; adjusting at least one parameter of the first stimulation pattern to provide a second stimulation pattern comprising a second stimulation setting configured to reduce or prevent atrial kick in at least one ventricle, the second stimulation setting being based upon the at least one blood pressure variation parameter; and providing the second stimulation pattern for a second time interval.

Overall, the independent claims collectively cover systems and methods that deliver atrial stimulation together with first and second ventricle stimulation via separate electrodes, using controller-executed stimulation patterns with settings that reduce or prevent atrial kick by preventing atrial contraction, and at least one independent method claim further adds closed-loop adjustment based on blood pressure variation parameters.

Stated Advantages

Reduces blood pressure by reducing or preventing atrial kick by preventing at least one atrial contraction of the heart.

Limits cardiovascular adaptation and spike behavior by providing inconsistent stimulation patterns, including different AV delays/settings or baroreflex-modulating settings, so stimulation can be made inconsistent to reduce adaptation.

Provides immediate blood pressure reduction and quantifies adaptation behavior under different pulse sequences/AV delays in examples described (hypertensive patients/canines).

Documented Applications

Electrical stimulation in hypertensive patients/canines to reduce blood pressure, including immediate blood pressure reduction and characterization of adaptation under different pulse sequences/AV delays.

Controller-based operation using sensors (blood pressure, blood flow, heart sound, and/or ultrasound/echocardiography Doppler) to adjust stimulation patterns based on sensed atrial excitation and/or atrioventricular valve status.

Closed-loop selection/adjustment of stimulation patterns toward a target blood pressure while limiting between-pulse blood pressure spikes, as described in the disclosure.

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