Methods and systems for controlling blood pressure
Inventors
Mika, Yuval • Sherman, Darren • Schwartz, Robert S. • Van Tassel, Robert A. • Burkhoff, Daniel
Assignees
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Publication Number
US-11426589-B2
Publication Date
2022-08-30
Expiration Date
Abstract
Systems and methods for controlling blood pressure via electrical stimulation of the heart are disclosed. Embodiments may include at least two different stimulation patterns, each configured to reduce blood pressure to a different degree, and may alternate between stimulation patterns based on the need of a patient, for example, alternating between day and night or between periods of strenuous and light activity. Some embodiments may take advantage of a slow baroreflex response that occurs after treatment is stopped, suspending treatment for extended periods, and then resuming treatment before blood pressure levels reach pretreatment values. Embodiments may control blood pressure by controlling atrial pressure and atrial stretch.
Core Innovation
The invention relates to systems and delivery techniques for reducing blood pressure in a patient having a pretreatment blood pressure by electrical stimulation of at least one cardiac chamber. The system includes a stimulation circuit for delivering stimulation pulses and at least one controller for executing one or more stimulation patterns of stimulation pulses over a time interval. Different stimulation patterns are arranged so that a first stimulation pattern reduces blood pressure by a first reduction amount, and a second stimulation pattern reduces blood pressure by a second reduction amount that is less than the first reduction amount but greater than zero.
A core aspect is the way the controller switches between the first and second stimulation patterns. The controller switches from delivery of the first stimulation pattern to delivery of the second stimulation pattern by adjusting gradually a degree of blood pressure change of the first stimulation pattern using transient incremental adjustment or continuous adjustment of a parameter affecting the degree of blood pressure change. This switching is defined so that, upon discontinuing delivery of the first stimulation pattern, a post-treatment blood pressure remains less than the pretreatment blood pressure.
In addition, the disclosed approach supports sensor-based and timing-based control synchronized to the patient’s intrinsic heart excitation. A system includes at least one sensor configured to sense excitation of the heart, while the controller delivers pacing to a first cardiac chamber and, after a delay, paces a second cardiac chamber to obtain a desired blood pressure change. The controller receives intrinsic excitation signals, determines a blood pressure change resulting from a delay, compares it to the desired blood pressure change, and adjusts the delay so that the blood pressure change becomes substantially equal to the desired blood pressure change, then delivers stimulation patterns comprising pulses having the adjusted delay between sensing and delivering the stimulation pulse.
Claims Coverage
The independently stated claims cover a blood-pressure-reducing stimulation system and a delay-adjusting method. Across these independent claims, four main inventive features are explicitly recited: dual stimulation patterns with different reduction amounts, gradual switching that preserves a post-treatment reduction, intrinsic-excitation sensing with delay-based pacing between cardiac chambers to match a desired blood pressure change, and delivery of pulses having an adjusted inter-chamber delay determined by comparing measured blood pressure changes to the desired change.
Dual stimulation patterns with different reduction amounts
A first stimulation pattern reduces the blood pressure of the patient by a first reduction amount, and a second stimulation pattern reduces the blood pressure of the patient by a second reduction amount, where the first reduction amount is greater than the second reduction amount and the second reduction amount is greater than zero.
Gradual switching to preserve post-treatment blood pressure reduction
The controller switches from delivery of the first stimulation pattern to delivery of the second stimulation pattern by adjusting gradually a degree of blood pressure change of the first stimulation pattern by using transient incremental adjustment or continuous adjustment of a parameter affecting the degree of blood pressure change, such that, upon discontinuing of the delivery of the first stimulation pattern, a post-treatment blood pressure of the patient remains less than the pretreatment blood pressure.
Sensor-based intrinsic excitation pacing with adaptive delay matching
The controller delivers the first stimulation pattern by pacing a first cardiac chamber and, after a first delay, pacing a second cardiac chamber to obtain a desired blood pressure change, receiving sensor signals indicating intrinsic excitation of the first cardiac chamber, determining a blood pressure change resulting from a delay, comparing the blood pressure change to the desired blood pressure change, and adjusting the second delay to a third delay intended to adjust the blood pressure change closer to the desired blood pressure change.
Delivering stimulation pulses with the adjusted inter-chamber delay
The controller determines that a second blood pressure change is substantially equal to the desired blood pressure change and delivers stimulation patterns comprising pulses having the third delay between sensing intrinsic excitation of the first cardiac chamber and delivering a stimulation pulse to the second cardiac chamber.
The independent claim set is directed to an electrical stimulation system and a closed-loop pacing method that reduce blood pressure using first and second stimulation patterns with different blood-pressure reduction amounts, switch between the patterns using gradual adjustment to maintain a post-treatment reduction, and synchronize pacing to intrinsic heart excitation while adaptively adjusting inter-chamber delay so the resulting blood pressure change becomes substantially equal to a desired blood pressure change.
Stated Advantages
Maintains post-treatment blood pressure less than pretreatment blood pressure after discontinuing delivery of the first stimulation pattern.
Enables delivery of stimulation patterns that achieve a blood pressure change substantially equal to a desired blood pressure change through adaptive delay adjustment based on intrinsic excitation sensing.
Documented Applications
An implantable blood-pressure–reducing cardiac stimulation system with operating schemes including switching between stimulation patterns based on blood pressure variation and delivery contexts such as circadian day/night and activity-based switching.
Reducing atrial kick by timing valve closure relative to atrial contraction, with feedback options and discussion of artificial valve control embodiments and reported acute blood-pressure reduction in animal examples.
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