Advanced cardiovascular monitoring system with normal, elevated, and high heartrate thresholds
Inventors
Fischell, David R. • John, Michael Sasha • Keenan, David • Johnson, Steve • Turi, Gregg
Assignees
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Publication Number
US-11980450-B1
Publication Date
2024-05-14
Expiration Date
Abstract
Systems and Methods are disclosed for detecting acute coronary syndrome (ACS) events, arrythmias, heart rate abnormalities, medication problems such as non-compliance or ineffective amount or type of medication, and demand/supply related cardiac ischemia. The system may have both implanted and external components that communicate with a Physicians's programmer, and smart-devices for monitoring and alerting to detected medically relevant events or states. At least one processor provides event detection using statistical threshold criteria calculated upon at least a portion of a patient's data/distributions and set for a patient or based upon what a doctor determines as abnormal for a patient. Cardiovascular condition is tracked using histogram, trend, and summary information related to heart rate and/or cardiac features such as S-T segment measures of heartbeats. Heartbeats with elevated rates, and below a “high” range, provide medically relevant detections including medication non-compliance where the patient is alerted through a patient alerting mechanism of an abnormality in the heart rate or ST shifts of the patient.
Core Innovation
The invention describes a system for monitoring a patient’s heart rate and alerting the patient of an abnormal condition indicative of patient beta blocker non-compliance or improper beta blocker dosing. The system includes at least two implanted electrodes adapted to sense electrical signals from the heart and electronic circuitry coupled to the electrodes for sensing and electronically operating on the sensed electrical signals to provide operational electronic signals. A processor calculates and allows a user to adjust and select heart rate related parameters including a normal heart rate range having an upper limit, a high heart rate lower threshold for detecting tachycardia, and an elevated heart rate range lying between the normal heart rate upper limit and the high heart rate lower threshold.
The system computes and stores an average heart rate during a pre-programmed time period for a multiplicity of heart beats, and the patient alerting mechanism automatically alerts the patient according to an alerting protocol without input by the patient. The alert is triggered when the computed average heart rate for a portion of the multiplicity of heart beats is within the elevated heart rate range. The system also responsively detects excessive ST shifts as a function of the heart rate normal range and alerts the patient of beta blocker non-compliance or improper beta blocker dosing following detection of a patient’s heart rate meeting at least one beta blocker non-compliance detection criterion for the pre-programmed time period.
In additional claimed aspects, the invention digitizes an electrogram into electrogram segments, extracts at least one baseline heart signal parameter value at a first predetermined time, and detects a cardiac event when a heart signal extracted at a second predetermined time shifts by more than a predetermined threshold amplitude from the baseline. The invention also includes detecting a prolonged period of electrogram segments having an elevated heart rate when the computed average heart rate is in the elevated heart rate range for at least 50% of electrogram segments over a pre-set time period. Other aspects include using an implanted device to compute average heart rate over pre-set periods and detect selected abnormalities including high heart rate, low heart rate, elevated heart rate lasting more than 2 hours, and irregular heart rate based on R-R interval relationships.
Claims Coverage
The provided content includes three independent claims. The inventive features cover implanted electrode sensing, average heart rate computation over pre-programmed or pre-set time periods, abnormality detection using defined normal/elevated/high ranges and thresholds, prolonged elevated heart rate proportion criteria, and automatic patient alerting in response to detection of beta blocker non-compliance or improper beta blocker dosing and related cardiac event conditions.
Beta blocker non-compliance and improper dosing alerting using elevated heart rate with ST-shift detection
A system comprising implanted electrodes to sense heart electrical signals, circuitry coupled to electrodes for sensing and operating on the sensed electrical signals, a processor selecting normal, high, and elevated heart rate ranges, and a processor computing and storing an average heart rate during a pre-programmed time period; the processor detects excessive ST shifts as a function of the heart rate normal range and automatically alerts the patient to beta blocker non-compliance or improper beta blocker dosing after detection of a patient’s heart rate meeting at least one beta blocker non-compliance detection criterion for the pre-programmed time period, with the alerting protocol requiring no patient input and informing the user specifically about detection of cardiac activity reflective of beta blocker non-compliance or improper beta blocker dosing.
Digitizing electrogram segments and detecting events via baseline shift and prolonged elevated heart rate
An implanted cardiac monitoring and alerting system including an analog-to-digital converter to digitize an electrogram into electrogram segments each having a time duration at least 1 second, processors to extract at least one baseline heart signal parameter value at a first predetermined time and to extract heart signal from a plurality of segments at a later predetermined time, storing baseline parameter values and normal and elevated heart rate limits, detecting a cardiac event when the extracted heart-rate signal shifts by more than a predetermined threshold amplitude from the baseline heart signal parameter value, and computing an average heart rate of each electrogram segment to detect a prolonged period of electrogram segments having an elevated heart rate when the computed average heart rate is in the elevated heart rate range for at least 50% of electrogram segments over a pre-set time period.
Average heart rate over pre-set time periods with normal/elevated/high abnormality detection
An implanted cardiac monitoring device including a connector and implantable lead with at least one electrode for sensing electrical signals from the patient’s heart, circuitry for digitizing the sensed electrical signal, processing to compute an average heart rate over a multiplicity of pre-set periods of time, digital memory storing pre-set lower and upper limits for a normal range and pre-set lower and upper limits for an elevated range, and a processor adapted to detect abnormalities selected from high heart rate, low heart rate, elevated heart rate lasting more than 2 hours, and irregular heart rate based on R-R intervals and a first pre-set percentage of beats relative to an irregular heart rate time period.
Across the independent claims, the coverage centers on implanted electrode sensing with electronic circuitry and processors to compute average heart rate during pre-programmed or pre-set time periods, defining normal/elevated/high heart rate ranges and thresholds, prolonged elevated heart rate criteria using segment or beat proportions over time periods, and additional detection of excessive ST shifts as a function of a heart rate normal range tied to automatic alerts for beta blocker non-compliance or improper beta blocker dosing, with event detection aspects in the electrogram baseline-shift framework.
Stated Advantages
Automatically alerting the patient according to an alerting protocol without input by the patient.
Alerting is based on detection of cardiac activity reflective of beta blocker non-compliance or improper beta blocker dosing and informing the user specifically about such detection.
Avoiding triggering a beta blocker non-compliance alert due to an inability to collect baseline data over a specified time period.
Detecting excessive ST shifts as a function of the heart rate normal range.
Documented Applications
No documented applications found
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