Chronic blood pressure monitoring using heart sounds
阅读说明:本技术 使用心音的慢性血压监测 (Chronic blood pressure monitoring using heart sounds ) 是由 普拉莫德辛格·希拉辛格·塔库尔 迈克尔·J·凯恩 杰弗里·E·施塔曼 基思·R·迈莱 于 2019-02-06 设计创作,主要内容包括:本文档中讨论了一种系统和方法,使用接收到的生理信息来确定患者心脏收缩性的指示,以及使用心音信息和所确定的心脏收缩性的指示来确定患者的血压信息。所述系统可以包括评估电路,其被配置成使用患者的第一心音(S1)信息来确定患者心脏收缩性的指示,并且使用患者的第二心音(S2)信息和所确定的心脏收缩性的指示来确定患者的血压信息。(A system and method are discussed in this document for determining an indication of cardiac contractility of a patient using received physiological information, and for determining blood pressure information of the patient using heart sound information and the determined indication of cardiac contractility. The system may include an evaluation circuit configured to determine an indication of cardiac contractility of the patient using first heart sound (S1) information of the patient, and determine blood pressure information of the patient using second heart sound (S2) information of the patient and the determined indication of cardiac contractility.)
1. A system, comprising:
a signal receiving circuit configured to receive physiological information of a patient, including heart sound information of the patient; and
an evaluation circuit configured to:
determining an indication of cardiac contractility of the patient using the received physiological information; and
determining blood pressure information of the patient using the heart sound information and the determined indication of cardiac contractility.
2. The system of claim 1, wherein the evaluation circuit is configured to determine blood pressure information of the patient using second heart sound (S2) information of the patient.
3. The system of any one of claims 1-2, wherein the evaluation circuit is configured to determine the indication of cardiac contractility using heart sound information of the patient.
4. The system of claim 3, wherein the evaluation circuit is configured to determine the indication of cardiac contractility using first heart sound (S1) information of the patient.
5. The system of claim 4, wherein the evaluation circuit is configured to determine blood pressure information of the patient using second heart sound (S2) information of the patient within a specified range of contractility determined using the first heart sound (S1) information of the patient.
6. The system of any one of claims 1-5, wherein the evaluation circuit is configured to:
determining an indication of the cardiac contractility for a first cardiac cycle; and
determining blood pressure information of a patient using the heart sound information for the first cardiac cycle if the determined indication of cardiac contractility for the first cardiac cycle is within a threshold range.
7. The system of claim 6, wherein the evaluation circuit is configured to:
determining an indication of the cardiac contractility for the first cardiac cycle using first heart sound (S1) information from the first cardiac cycle of the patient; and
determining blood pressure information of the patient using second heart sound (S2) information from the first cardiac cycle of the patient if the determined indication of cardiac contractility for the first cardiac cycle is within a threshold range.
8. The system of claim 7, wherein the threshold range has an upper bound threshold amount above an intermediate S1 value for the patient.
9. The system according to any of claims 1-8, comprising:
a heart sound sensor configured to detect heart sound information from a patient and determine first heart sound (S1) information and second heart sound (S2) information using the heart sound information,
wherein the signal receiving circuit is configured to receive physiological information of a patient including the first heart sound (S1) information and the second heart sound (S2) information.
10. The system of claim 9, wherein the first heart sound (S1) information includes at least one of a first heart sound (S1) amplitude or energy, and the second heart sound (S2) information includes at least one of a second heart sound (S2) amplitude or energy.
11. At least one machine readable medium comprising instructions that when executed by a medical device, cause the medical device to:
receiving physiological information of a patient, including heart sound information of the patient;
determining an indication of cardiac contractility of the patient using the received physiological information; and
determining blood pressure information of the patient using the heart sound information and the determined indication of cardiac contractility.
12. The at least one machine readable medium of claim 11, wherein the instructions which, when executed by the medical device, cause the medical device to determine an indication of cardiac contractility comprise instructions to:
determining the indication of cardiac contractility using first heart sound (S1) information of the patient.
13. The at least one machine readable medium of any of claims 11-12, wherein the instructions that when executed by the medical device cause the medical device to determine blood pressure information of a patient using the heart sound information comprise instructions to:
the blood pressure information of the patient is determined using the second heart sound (S2) information of the patient.
14. The at least one machine readable medium of claim 13, wherein the instructions which, when executed by the medical device, cause the medical device to determine blood pressure information of a patient using second heart sound (S2) information include instructions which perform the steps of:
within a specified range of contractility determined using the first heart sound (S1) information of the patient, determining blood pressure information of the patient using second heart sound (S2) information of the patient.
15. The at least one machine readable medium of any of claims 11-14, wherein the instructions that when executed by the medical device cause the medical device to determine an indication of cardiac contractility comprise instructions to:
determining whether the indication of cardiac contractility for the first cardiac cycle is within a threshold range using first heart sound (S1) information of the patient, and
wherein the instructions that, when executed by the medical device, cause the medical device to determine blood pressure information of a patient comprise instructions to:
determining blood pressure information of the patient using second heart sound (S2) information from the first cardiac cycle of the patient if the determined indication of cardiac contractility for the first cardiac cycle is within a threshold range.
Technical Field
This document relates generally to medical devices and, more particularly, but not by way of limitation, to systems, devices and methods for chronic monitoring of blood pressure using heart sounds.
Background
Blood pressure is the pressure of the circulating blood on the walls of blood vessels and generally refers to the pressure in the aorta of the systemic system. When further specified, such as Left Ventricular (LV) pressure, etc., such pressure refers to pressure in the physiological portion. Blood pressure is usually expressed in terms of systolic and diastolic blood pressure. Systolic pressure refers to the maximum pressure at which the heart contracts, diastolic pressure refers to the minimum pressure between contractions of the heart, measured in millimeters of mercury (mmHg) per contraction.
Hypertension is a risk factor leading to death and also to other adverse medical events including, for example, congestive heart failure, ischemia, cardiac arrhythmias, stroke, acute cardiac decompensation, organ failure, and the like. Hypertension is also asymptomatic, so the patient is not aware of his condition until an adverse medical event occurs. Therefore, it is important to monitor blood pressure information, such as to monitor or assess a condition or state of a patient, including deterioration or recovery of one or more physiological conditions, or to supplement other detection or determination.
Disclosure of Invention
This document discusses, among other things, systems and methods to determine an indication of cardiac contractility of a patient using received physiological information and to determine blood pressure information of the patient using heart sound information and the determined indication of cardiac contractility. The system may include an evaluation circuit configured to determine an indication of cardiac contractility of the patient using first heart sound (S1) information of the patient, and determine blood pressure information of the patient using second heart sound (S2) information of the patient and the determined indication of cardiac contractility.
An example (e.g., "example 1") of a subject (e.g., a system) may include a signal receiving circuit configured to receive physiological information of a patient including heart sound information of the patient; and an evaluation circuit configured to: determining an indication of the contractility of the patient's heart using the received physiological information; and determining blood pressure information of the patient using the heart sound information and the determined indication of cardiac contractility.
In example 2, the subject matter of example 1 can optionally be configured such that the evaluation circuit is configured to determine blood pressure information of the patient using second heart sound (S2) information of the patient.
In example 3, the subject matter of any one or more of examples 1-2 can optionally be configured such that the evaluation circuit is configured to determine the indication of cardiac contractility using heart sound information of the patient.
In example 4, the subject matter of any one or more of examples 1-3 can optionally be configured such that the evaluation circuit is configured to determine the indication of cardiac contractility using first heart sound (S1) information of the patient.
In example 5, the subject matter of any one or more of examples 1-4 can optionally be configured such that the evaluation circuitry is configured to determine blood pressure information of the patient using second heart sound (S2) information of the patient within a specified range of contractility determined using the first heart sound (S1) information of the patient.
In example 6, the subject matter of any one or more of examples 1-5 can optionally be configured such that the evaluation circuitry is configured to:
determining an indication of cardiac contractility for the first cardiac cycle; and if the determined indication of cardiac contractility for the first cardiac cycle is within a threshold range, determining blood pressure information of the patient using heart sound information for the first cardiac cycle.
In example 7, the subject matter of any one or more of examples 1-6 can optionally be configured such that the evaluation circuitry is configured to: determining an indication of cardiac contractility for a first cardiac cycle using first heart sound (S1) information from the patient for the first cardiac cycle; and if the determined indication of cardiac contractility for the first cardiac cycle is within a threshold range, determining blood pressure information of the patient using second heart sound (S2) information from the first cardiac cycle of the patient.
In example 8, the subject matter of any one or more of examples 1-7 can optionally be configured such that the threshold range has an upper bound threshold amount above the intermediate S1 value for the patient. In one example, the upper bound of the threshold range may be 25% greater than the intermediate S1 value for the patient. In other examples, the threshold range may be one or more other values.
In example 9, the subject matter of any one or more of examples 1-8 can optionally be configured to include a heart sound sensor configured to detect heart sound information from a patient and to determine first heart sound (S1) information and second heart sound (S2) information using the heart sound information, wherein the signal receiving circuit is configured to receive physiological information of the patient including the first heart sound (S1) information and the second heart sound (S2) information.
In example 10, the subject matter of any one or more of examples 1-9 may optionally be configured such that the first heart sound (S1) information includes at least one of a first heart sound (S1) amplitude or energy, and the second heart sound (S2) information includes at least one of a second heart sound (S2) amplitude or energy.
An example (e.g., "example 11") of a subject (e.g., at least one machine-readable medium) may include instructions that, when executed by a medical device, cause the medical device to: receiving physiological information of a patient, including heart sound information of the patient; determining an indication of cardiac contractility of the patient's heart using the received physiological information; and determining blood pressure information of the patient using the heart sound information and the determined indication of cardiac contractility.
In example 12, the subject matter of example 11 may optionally be configured such that the instructions that, when executed by the medical device, cause the medical device to determine an indication of cardiac contractility comprise instructions to: an indication of cardiac contractility is determined using first heart sound (S1) information of the patient.
In example 13, the subject matter of any one or more of examples 11-12 may optionally be configured such that, when executed by the medical device, the instructions that cause the medical device to determine blood pressure information of a patient using the heart sound information comprise instructions that perform the steps of: the patient 'S blood pressure information is determined using the patient' S second heart sound (S2) information.
In example 14, the subject matter of any one or more of examples 11-13 may optionally be configured such that, when executed by the medical device, the instructions that cause the medical device to determine blood pressure information of a patient using second heart sound (S2) information include instructions that perform the steps of: determining blood pressure information of the patient using second heart sound (S2) information of the patient within a specified range of contractility determined using the first heart sound (S1) information of the patient.
Examples (e.g., "example 15") of the subject matter (e.g., a method) may include receiving, using a signal receiving circuit, physiological information of a patient including heart sound information of the patient; determining, using the evaluation circuit, an indication of the patient's cardiac contractility using the received physiological information; and determining, using the evaluation circuit, blood pressure information of the patient using the heart sound information and the determined indication of cardiac contractility.
In example 16, the subject matter of example 15 may optionally be configured such that determining the indication of cardiac contractility comprises using first heart sound (S1) information of the patient, wherein determining the blood pressure information of the patient comprises using second heart sound (S2) information of the patient.
In example 17, the subject matter of any one or more of examples 15-16 may optionally be configured such that determining the blood pressure information of the patient includes using the second heart sound (S2) information of the patient within a specified range of contractility determined using the first heart sound (S1) information of the patient.
In example 18, the subject matter of any one or more of examples 15-17 may optionally be configured such that the patient 'S first heart sound (S1) information includes at least one of a first heart sound (S1) amplitude or energy, and the patient' S second heart sound (S2) information includes at least one of a second heart sound (S2) amplitude or energy.
In example 19, the subject matter of any one or more of examples 15-18 may optionally be configured such that determining the indication of cardiac contractility comprises determining the indication of cardiac contractility for the first cardiac cycle using first heart sound (S1) information from the patient for the first cardiac cycle, wherein if the determined indication of cardiac contractility for the first cardiac cycle is within a threshold range, determining the blood pressure information of the patient comprises using second heart sound (S2) information from the patient for the first cardiac cycle.
In example 20, the subject matter of any one or more of examples 15-19 may optionally be configured such that the threshold range has an upper bound threshold amount above the intermediate S1 value for the patient.
An example (e.g., "example 21") of subject matter (e.g., a system or apparatus) may optionally combine any portion of any one or more of examples 1-20 or any combination of portions to include a "method" or "non-transitory machine-readable medium" for performing any portion of any one or more of the functions or methods of examples 1-20, comprising instructions that, when executed by a machine, cause the machine to perform any portion of any one or more of the functions or methods of examples 1-20.
This summary is intended to provide an overview of the subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the disclosure. The detailed description is included to provide further information regarding the present patent application. Other aspects of the disclosure will become apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the accompanying drawings that form a part hereof, and wherein each of the drawings is not to be construed in a limiting sense.
Drawings
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. By way of example, and not limitation, the figures generally illustrate various embodiments discussed in this document.
Fig. 1 illustrates portions of an example patient management system and environment in which the system may operate.
Fig. 2A-2C illustrate example relationships of Left Ventricular (LV) pressure and LV volume at different levels of preload, afterload, and contractile force.
Fig. 3 shows an example system that includes a signal receiving circuit and an evaluation circuit.
4-5 illustrate example methods to determine blood pressure information using an indication of determined contractility.
Fig. 6 illustrates a block diagram of an example machine on which any one or more of the techniques discussed herein may be performed.
Detailed Description
Conventional blood pressure measurements include non-invasive measurements, such as using mercury manometers or blood pressure cuffs. However, such measurements can be cumbersome, tend to be inaccurate, discontinuous (e.g., hourly or daily intervals, etc.), and tend to lack patient flexibility when used for ambulatory or chronic measurements. In contrast, implanted systems that include a blood pressure sensor that continuously measures blood pressure may not be invasive or require additional, unnecessary sensors, which increases the complexity and cost of the system. Implantable pressure sensors are not suitable for outpatient or long-term use. Further, in certain examples, implanted systems that continuously measure or infer blood pressure using one or more other sensors (e.g., at more frequent intervals than hourly or daily, such as at each cardiac cycle, or cycle of cardiac cycles, etc.) may be inaccurate, include noisy cycles or inaccurate measurements, or require frequent and expensive calibration to maintain accuracy. In some examples, reducing such periods of noise or inaccurate measurements is more conducive to accurately determining blood pressure, and in some examples, reducing the cost or complexity of the flow system is more conducive to determining blood pressure using existing, dual or multi-purpose sensors as opposed to dedicated pressure sensors. Furthermore, it is beneficial to continuously determine the blood pressure at each cardiac cycle or at each qualified cardiac cycle.
Heart sounds are recurring mechanical signals associated with the vibration of the heart from the blood flow through the heart at each cardiac cycle and can be separated and classified according to the activity associated with the vibration and the blood flow. Heart sounds include four main sounds: first heart sound through fourth heart sound. The first heart sound (S1) is the vibratory sound emitted by the heart at the beginning of systole when closing the Atrioventricular (AV) valve, the mitral valve, and the tricuspid valve. The second heart sound (S2) is a vibrational sound emitted by the heart when the aortic and pulmonary valves are closed at the beginning of diastole. The third and fourth heart sounds (S3, S4) are related to the filling pressure of the left ventricle at diastole.
When the left ventricle relaxes after contraction and the pressure in the left ventricle drops below that of the left atrium, the mitral valve opens and the left atrium begins to fill the left ventricle. When the left ventricle contracts, the pressure in the left ventricle rises rapidly. When the pressure in the left ventricle is higher than the pressure in the left atrium, the mitral valve will close rapidly, isolating the left ventricle from the left atrium, generating a first heart sound. The mitral valve is closed in time, and when the pressure of the left ventricle is higher than that of the aorta, the aortic valve is opened, so that blood flows out of the left ventricle through the aorta and is supplied to other parts of the body. The maximum pressure in the left ventricle at systole, i.e., systolic pressure, represents the maximum systemic pressure in the left ventricular postsystolic artery (e.g., typically 100-.
When the left ventricle relaxes, the pressure in the left ventricle drops. When the pressure in the left ventricle is lower than the pressure of the aorta, the aortic valve closes rapidly, isolating the left ventricle from the aorta, producing a second heart sound. The pressure in the arterial system when the aortic valve opens is the systemic diastolic pressure (e.g., typically 60-100mmHg, etc.). The aortic valve is closed in time and when the pressure in the left ventricle is lower than the pressure in the left atrium, the mitral valve opens, filling the left ventricle. The minimum pressure in the left ventricle after systole is the left ventricular diastolic pressure (e.g., typically down to 5-10mmHg, etc.), which may be of a different magnitude and time than the systemic diastolic pressure.
The heart valve switches states between open and closed at different times in the cardiac cycle. These valve states change when there is a certain relative pressure in the heart and the major blood vessels leading from the heart (e.g., the aorta). By various methods, both the valve state change and the effect of the state change are detectable. For example, valve closure causes vibrations of the heart wall, which can be detected with an accelerometer or microphone. Valve motion can be detected directly by imaging techniques such as echocardiography and Magnetic Resonance Imaging (MRI), or intracardiac impedance plethysmography.
The heart sounds may be used to detect various physiological conditions including, for example, acute physiological events such as one or more abnormal heart rhythms (e.g., atrial fibrillation, atrial flutter, cardiac mechanical dyssynchrony, etc.), and more chronic physiological events such as congestive heart failure, ischemia, etc.
Further, the heart sounds may be correlated with certain physiological information, such that in certain examples, the heart sound information may be used as a substitute for or to detect one or more physiological characteristics. For example, heart sounds may be used to detect atrial filling pressure, such as described in commonly assigned U.S. patent No.7,972,275(Siejko et al) entitled "method and apparatus for monitoring diastolic hemodynamics," or commonly assigned U.S. patent No.8,048,001(Patangay et al), entitled "method and apparatus for detecting atrial filling pressure," each of which is incorporated herein by reference in its entirety.
Heart sounds are usually related to blood pressure. Chronic monitoring of blood pressure based on frequency and/or amplitude components of the first and second heart sounds has been proposed. However, the inventors have recognized, among other things, that the relationship between heart sound and blood pressure varies according to different, interdependent variables, with the heart sound tracking blood pressure in some examples, but not in other cases, and thus certain ventricular function or physiological information may be used to determine periods of increased and decreased correlation between blood pressure and heart sound. The increase and decrease of the correlation may be used to improve sensitivity or specificity of blood pressure detection using heart sounds or to improve efficiency of data collection and storage to accurately monitor blood pressure using heart sounds. Thus, the methods and systems described herein may provide, in certain examples, more robust blood pressure monitoring using less storage or data processing than existing flow systems or devices.
Ambulatory medical devices, including implantable, wireless, or wearable medical devices, may be configured to monitor, detect, or treat various cardiac disorders. Various ambulatory medical devices may be implanted in or placed on or around a patient to monitor physiological information of the patient, such as heart sounds, respiration (e.g., respiratory rate, tidal volume, etc.), impedance (e.g., thoracic impedance, cardiac impedance, etc.), pressure (e.g., blood pressure), cardiac activity (e.g., heart rate), physical activity, posture, or one or more other physiological parameters of the patient, or to provide electrical stimulation or one or more other therapies or treatments to optimize or control cardiac contraction.
Conventional Cardiac Rhythm Management (CRM) devices, such as pacemakers, defibrillators, or cardiac monitors, include a subcutaneous device configured to be implanted in the chest of a patient with one or more leads to position one or more electrodes or other sensors at various locations in the heart, such as in one or more of the atria or ventricles. Separate from or in addition to the one or more electrodes or other sensors of the lead, the CRM device may include one or more electrodes or other sensors (e.g., pressure sensors, accelerometers, gyroscopes, microphones, etc.) powered by a power source in the CRM device. The one or more electrodes or other sensors of the lead, CRM device, or combination thereof may be configured to detect physiological information from a patient, or to provide one or more therapies or stimuli to a patient.
Leadless Cardiac Pacemakers (LCPs) include small (e.g., smaller than conventional implantable CRM devices), self-contained devices configured to detect physiological information from the heart or provide one or more therapies or stimuli to the heart without the need for conventional leads or implantable CRM device complications (e.g., required incisions and pockets, complications associated with lead placement, breakage, or migration, etc.). In some examples, LCPs may have more limited power and processing capabilities than traditional CRM devices; however, multiple LCP devices may be implanted in or around the heart to detect physiological information from one or more chambers of the heart, or to provide one or more therapies or stimuli to one or more chambers of the heart. The LCP devices may communicate between each other, or between one or more other implanted devices or external devices.
Wearable or external medical sensors or devices may be configured to detect or monitor physiological information of a patient without the need for necessary implants or hospitalization, battery replacement or repair. However, such sensors and devices may reduce patient compliance, increase detection noise, or reduce detection sensitivity compared to implantable, subcutaneous, or leadless medical devices.
For each of the flow devices described above (e.g., implantable, leadless, or wearable medical devices, etc.), each additional sensor may increase system cost and complexity, decrease system reliability, or increase power consumption and shorten the useful life of the flow device. Thus, it may be beneficial to use a single sensor to determine multiple types of physiological information. In an example, an accelerometer, acoustic sensor, or other heart sound sensor may be used to determine heart sound information of a patient as well as blood pressure information or one or more other types of physiological information of the patient. The evaluation circuit may use the heart sound information to determine blood pressure information for the patient, and in some examples, use the determined blood pressure information to determine a level of patient status or risk or exacerbation, and provide an alert or indication to the patient or clinician so that the patient is hospitalized or hospitalized according to the diagnosis described above.
Fig. 1 illustrates an example
The
The flow system 105 may include an Implantable Medical Device (IMD)110, one or more Leadless Cardiac Pacemakers (LCPs), a wearable medical device 111, or one or more other implantable, leadless, subcutaneous, external, or wearable medical devices configured to monitor, sense, or detect information from the patient 102, determine physiological information about the patient 102, or provide one or more therapies to treat various cardiac disorders of the patient 102, such as the ability of the heart to adequately deliver blood to the body, including Atrial Fibrillation (AF), Congestive Heart Failure (CHF), hypertension, or one or more other cardiac disorders.
In an example, IMD110 may include one or more conventional Cardiac Rhythm Management (CRM) devices, such as a pacemaker, defibrillator, or cardiac monitor, implanted in the chest of a patient, with lead system 108 including one or more transvenous, subcutaneous, or non-invasive leads or catheters to position one or more electrodes or other sensors (e.g., heart sound sensors) in, on, or around the interior, surface, or periphery of the heart of patient 102 or one or more other locations in the chest, abdomen, or neck.
The IMD110 may include an evaluation circuit 160 configured to detect or determine specific physiological information of the patient 102, or to determine one or more conditions, or to provide information or alerts to a user (e.g., the patient 102, a clinician, or one or more other caregivers). The IMD110 may alternatively or additionally be configured as a therapy device configured to treat one or more conditions of the patient 102. The therapy may be delivered to the patient 102 via the lead system 108 and associated electrodes, or using one or more other delivery mechanisms. The therapy may include an anti-arrhythmic therapy to treat the arrhythmia or to treat or control one or more complications resulting from the arrhythmia, such as syncope, Congestive Heart Failure (CHF), stroke, or the like. Examples of anti-arrhythmic therapies include pacing, cardioversion, defibrillation, neuromodulation, drug therapy, or biologic therapy, among others. In other examples, the therapy may include Cardiac Resynchronization Therapy (CRT) for correcting dyssynchrony and improving cardiac function in a CHF patient. In some examples, the IMD110 may include a drug delivery system, such as a drug infusion pump, to deliver drugs to a patient for managing arrhythmias or complications resulting from arrhythmias, hypertension, or one or more other physiological conditions. In other examples,
The wearable medical device 111 may include one or more wearable or external medical sensors or devices (e.g., an Automated External Defibrillator (AED), a dynamic electrocardiograph, a patch-based device, a smart watch, a smart accessory, a wrist-or finger-worn medical device, etc.). Wearable medical device 111 may include an optical sensor configured to detect a photoplethysmogram (PPG) signal on a wrist, finger, or other location of a patient. In other examples, wearable medical device 111 may include an acoustic sensor or accelerometer to detect acoustic information (e.g., heart sounds) or sounds or vibrations of blood flow, an impedance sensor to detect changes in impedance associated with blood flow or changes in volume, a temperature sensor to detect changes in temperature associated with blood flow, a laser doppler vibrometer or other pressure, strain, or physical sensor to detect physical changes associated with blood flow, and so forth.
The external system 125 may comprise a dedicated hardware/software system, such as a programmer, a remote server-based patient management system, or alternatively, a system defined primarily by software running on a standard personal computer. The external system 125 may manage the patient 102 through the IMD110 connected to the external system 125 via the communication link 115. In other examples, IMD110 may be connected to wearable device 111 via communication link 115, or wearable device 111 may be connected to external system 125 via communication link 115. This may include, for example, programming the IMD110 to perform one or more of acquiring physiological data, performing at least one self-diagnostic test (e.g., for device operating status), analyzing the physiological data to detect arrhythmias, or optionally delivering or adjusting therapy to the patient 102. Additionally, the external system 125 may transmit information to or receive information from the IMD110 or wearable device 111 via the communication link 115. Examples of such information may include real-time or stored physiological data from the patient 102, diagnostic data, such as detection of an event of cardiac arrhythmia or worsening heart failure, response to therapy delivered to the patient 102, or device operating state (e.g., battery state, lead impedance, etc.) of the IMD110 or wearable device 111. The communication link 115 may be an inductive telemetry link, a capacitive telemetry link, or a Radio Frequency (RF) telemetry link, or a wireless telemetry based on, for example, "strong" bluetooth or IEEE 802.11 wireless fidelity "Wi-Fi" interface standards. Other configurations and combinations of patient data source interfaces are possible.
By way of example and not limitation, the external system 125 may include an external device 120 in proximity to the IMD110, and a remote device 124 in a relatively remote location from the IMD110 that communicates with the external device 120 over a telecommunications network 122. An example of the external device 120 may include a medical device programmer.
The remote device 124 may be configured to, among other possible functions, evaluate the collected patient information and provide alert notifications. In an example, the remote device 124 may include a centralized server that acts as a central hub for the collected patient data storage and analysis. The servers may be configured as single-, multi-or distributed computing and processing systems. The remote device 124 may receive patient data from a plurality of patients including, for example, the patient 102. Patient data may be collected by the IMD110 in addition to other data acquisition sensors or devices associated with the patient 102. The server may include a memory device to store patient data in a patient database. The server may include an alarm analyzer circuit to evaluate the collected patient data to determine whether a particular alarm condition is satisfied. Meeting the alarm condition may trigger the generation of an alarm notification. In some examples, the alert condition may be alternatively or additionally evaluated by the IMD 110. For example, the alert notification may include a web page update, a telephone or pager call, an email, an SMS, a text or "instant" message, as well as a message to the patient and a simultaneous direct notification to emergency services and clinicians. Other alert notifications are possible. The server may include an alert sequencer circuit configured to prioritize alert notifications. For example, a similarity metric between physiological data associated with the detected medical event and physiological data associated with historical alerts may be used to determine a priority of an alert for the detected medical event.
Remote device 124 may additionally include one or more locally configured or remote clients that securely connect to the server over network 122. Examples of clients may include personal desktops, laptops, mobile devices, or other computing devices. A system user (e.g., a clinician or other qualified medical professional) may use a client to securely access patient data stored in a database in a server and select and prioritize patients and alerts for healthcare provisioning. In addition to generating the alert notification, the remote device 124, including the server and interconnected clients, may also perform follow-up protocols as compliance notifications by sending follow-up requests to the IMD110, or by sending messages or other communications to the patient 102, a clinician, or an authorized third party.
The network 122 may provide wired or wireless interconnection. In an example, the network 122 may be based on a transmission control protocol/Internet protocol (TCP/IP) network communication specification, although other types or combinations of network implementations are possible. Similarly, other network topologies and arrangements are possible.
One or more of the external device 120 or the remote device 124 may output the detected medical event to a system user, such as a patient or clinician, or to a process including an instance of a computer program executable, for example, in a microprocessor. In an example, the process may include automatically generating recommendations for anti-arrhythmic therapy, or recommendations for further diagnostic tests or treatments. In an example, the external device 120 or the remote device 124 may include respective display units for displaying physiological or functional signals, or alarms, alerts, emergency calls, or other forms of alerts to signal detection of an arrhythmia. In some examples, the external system 125 may include an external data processor configured to analyze physiological or functional signals received by the IMD110 and confirm or reject detection of the arrhythmia. A computationally intensive algorithm, such as a machine learning algorithm, may be implemented in the external data processor to retrospectively process the data to detect arrhythmias.
Portions of the IMD110 or the external system 125 may be implemented using hardware, software, firmware, or a combination thereof. Portions of the IMD110 or the external system 125 may be implemented using dedicated circuitry that may be constructed or configured to perform one or more functions, or may be implemented using general-purpose circuitry that may be programmed or otherwise configured to perform one or more functions. Such general purpose circuitry may include a microprocessor or portion thereof, a microcontroller or portion thereof, or programmable logic circuitry, memory circuitry, network interfaces, and various components for interconnecting these components. For example, a "comparator" may include, among other things, an electronic circuit comparator that may be configured to perform the particular function of comparing between two signals, or the comparator may be implemented as part of a general purpose circuit that may be driven by code that instructs a portion of the general purpose circuit to perform a comparison between the two signals.
2A-2C illustrate example pressure-volume (PV) rings showing the relationship between Left Ventricular (LV) pressure and LV volume at different levels of preload, afterload and contractile force, each of which interdependent variables affect ventricular function.
Preload refers to the initial stretching of the cardiomyocytes prior to contraction, and is therefore related to the sarcomere length. As blood volume increases, the end-diastolic pressure and volume of the ventricles increase, which stretches the muscle segments, increasing preload. Conversely, as blood volume decreases, ventricular filling decreases, which shortens the sarcomere length, reducing preload.
Afterload refers to the load against which the heart must expel blood, and is closely related to aortic pressure unless aortic stenosis is present. The afterload is usually expressed as the chamber wall stress (σ):
where P is ventricular pressure, r is ventricular radius, and h is wall thickness.
Contractility or contractility refers to the force or energy of muscle contraction or fiber shortening. As the contraction force increases, the active tension at a given preload increases, which increases the rate of pressure change (e.g., dP/dt) during isovolumetric contraction.
At the lower left corner of the PV ring, the mitral valve opens. The LV volume increases during diastole until the right lower corner of the PV ring at end diastole, the mitral valve closes, and then systole begins. LV pressure increases during isovolumetric contraction until the upper right corner of the PV ring, the aortic valve opens. LV volume is reduced by ejection until, at the upper left corner of the PV ring at end systole, the aortic valve closes, and then diastole begins. LV pressure decreases during isovolumic relaxation until the mitral valve opens. The width of the PV ring (end diastole volume minus end systole volume) is the Stroke Volume (SV).
Fig. 2A shows a first pressure-volume (PV)
Fig. 2B shows a
Fig. 2C shows a PV ring showing the relationship between LV pressure and LV volume at different levels of contractile force (e.g.,
2A-2C show that changes in preload or contractile force have no significant effect on LV end systolic pressure, changes in afterload or contractile force have no significant effect on LV end diastolic volume, and changes in preload or afterload have no significant effect on the end systolic pressure-volume relationship (ESPVR), whereas changes in contractile force affect ESPVR.
To study the effect of afterload and contractile changes on heart sound and blood pressure, phencynomolgus hormone and nitroglycerin were used to change afterload and dobutamine was used to change contractility. The inventors recognized, among other things, that while the relationship between S2 and blood pressure changes substantially coincided with changes in afterload, the relationship between S2 and blood pressure was significantly affected by contractile changes. Furthermore, the inventors have recognized that S1 can be used to determine a constant state of contractility or a state without significant change in contractility, since S1 is essentially related to contractility. Thus, the change in contractility and corresponding S1 may determine S2 a time period during which the blood pressure is substantially tracked, and a time period during which it does not track the blood pressure. Thus, S1 may be used to exclude segments with substantial contractile changes that adversely affect the correlation of S2 with blood pressure, thereby excluding the ability of S2 to track blood pressure. Alternatively, S1 can be used to adjust the S2 measurement to maintain its correlation with blood pressure.
In an example, S1 values other than the intermediate S1 value may be used to detect periods of substantial contractility change. An S1 value at or near the middle value (e.g., within 25% of the middle S1 value) may be used to determine a time period of insubstantial change in contractility. In other examples, an out-of-threshold S1 value (e.g., an S1 value greater than 25% of the intermediate S1 value) may be used to determine a period of substantial contractility change, and thus a period of decreased correlation of S2 with blood pressure.
In other examples, a range of values of S2 or S1 at a fixed value may be used as a marker for blood pressure. In an example, S2 can only be recorded and used for blood pressure calculations when the corresponding S1 is within an acceptable range of S1 values. In other examples, S2 may be recorded at different levels of S1 or systematically recorded, where changing the S1 value may indicate different levels of contractile force, such as monitoring blood pressure as a function of variable force status (e.g., movement, etc.). In other examples, S2 may be recorded or monitored at a particular level or range of S1, heart rate, impedance, systolic interval, or a particular combination thereof (e.g., S1 and heart rate, etc.).
In an example, a daily average or other average of shorter or longer time periods (e.g., wake up time, sleep time, active or inactive time periods in a day, long term (e.g., 30 days, 60 days, etc.) average, etc.) may be determined in a given range of S1 values or S1 values or in one or more other indications of contractility. For example, sleep blood pressure may be used to determine system drift. In other examples, S2 may be corrected using, for example, the contraction time interval (STI), pre-ejection period (PEP), Q-S2 time period, Left Ventricular Ejection Time (LVET), LV dP/dt, etc., in addition to or instead of using S1.
In an example, the indication of contractility may be activity related, and thus, certain contractility ranges may be used to determine resting blood pressure, blood pressure at light activity (e.g., normal function), or blood pressure at high intensity activity (e.g., exercise, etc.). In other examples, contractility may be associated with an activity, a gesture, or a combination thereof using, for example, an accelerometer, a gesture sensor (e.g., a magnetometer), or other activity sensors (e.g., number of steps, rate of steps, etc.). Ranges may correspond to different degrees of activity, posture, etc., or blood pressure at different levels of physiological information (e.g., contractility, activity, heart rate, respiration, etc.) may be further recorded using other sensors (e.g., heart rate, activity, etc.). Different tables may be created for different situations or information. For example, a table of S2 may be created within a given range of S1 or S1, alone or in combination with a given value or range of values for one or more other conditions or information, including, for example, heart rate, activity, posture, respiration (e.g., rate, pattern, etc.), and the like. In other examples, S2 or the blood pressure measurement or determination may be triggered using different physiological information (e.g., activity, etc.).
In other examples, the S2 information may be used in conjunction with one or more other physiological information (e.g., measurements or indications of one or more other conditions, etc.) to further determine blood pressure information. For example, if the patient has valvular heart disease, the determination of blood pressure may be appropriate to interpret the situation, may be detected using physiological information, or may be received from an ambulatory or external system (e.g., medical records, physician input, etc.). Mitral valve defects may affect S1, while aortic valve defects may affect S2. The ambulatory or external system can detect (e.g., using heart sound morphology, etc.) or receive an indication of such a condition, and can adjust the determination of blood pressure accordingly. In other examples, for example, only the maximum peak, the average of the two peaks, the first peak, etc. may be used to illustrate a split S1 or S2.
In an example, as the contractility increases, S1 may have a higher spectral content (e.g., energy transferred to higher frequencies). Thus, the spectral content of the heart sounds may be used to determine an indication of contractility. In an example, a filter may be used to filter frequencies associated with normal, low-systolic states. The output of the filter may be monitored and when unfiltered contents (e.g., aggregate, integral, RMS, or amplitude) exceed a threshold value, S2 may be ignored for determining blood pressure, or flagged for determination in a high contractile state. The morphology of S1 changes with contractility. In an example, as the contractility increases, the width (e.g., time) of S1 may decrease, or the slope of S1 may increase. Thus, S2 may be omitted or a different S1 morphological feature record S2 corresponding to various indications of contractility may be used. In other examples, the spectral content of S2 (e.g., an increase in higher frequency may indicate higher blood pressure), or the ratio of S2 to S1 may be used to further determine the correlation of S2 to blood pressure.
Fig. 3 shows an example system 300 that includes a signal receiving circuit 302 and an evaluation circuit 304. In an example, one or both of the signal receiving circuit 302 or the evaluation circuit 304 can be included in the flow system 105 or the external system 125. In other examples, one of the signal receiving circuit 302 or the evaluation circuit 304 may be included in the flow system 105, while the other may be included in the external system 125. In other examples, flow system 105 and external system 125 may include aspects of each of signal receiving circuit 302 and evaluation circuit 304.
The signal receiving circuit 302 may be configured to receive physiological information of the patient including, for example, heart sound information of the patient' S heart (e.g., first, second, third, or fourth heart sounds (S1-S4), etc.), or one or more other physiological information from the patient, such as contractility information, impedance information, respiration information, cardiac electrical information, or one or more other types of physiological information from the patient. In an example, the physiological information may include one or more of heart rate (e.g., chronology), posture, activity, one or more cardiac electrical or mechanical intervals (e.g., contraction time intervals (STIs), such as pre-ejection period (PEP), Q-S2 time period, Left Ventricular Ejection Time (LVET), LV dP/dt, etc.), between cardiac electrical events, between cardiac mechanical events, or between cardiac electrical and cardiac mechanical events, among others.
In an example, the system 300 may include a heart sound sensor, such as an accelerometer, microphone, or other mechanical or acoustic sensor, configured to sense heart sound information from the patient's heart. The heart sound sensor may be a component in the flow system 105. In other examples, the flow system 105 or the external system 125 may be configured to receive heart sound information, such as from a patient's heart.
The evaluation circuit 304 may be configured to determine an indication of the contractility of the patient's heart using the received physiological information. In an example, the patient' S1 information, or one or more other heart sound measurements, timings, or values, may be used to determine the contractility of the heart. For example, the change in contractility is reflected in S1 amplitude information, energy information (e.g., integrated energy or amplitude, RMS energy, spectral content, etc.). In some examples, the S1 information may be used to determine an indication of contractility. In other examples, contractility may be determined using a contraction time interval, one or more other cardiac electrical or mechanical intervals, impedance plethysmography, or other impedance changes of the patient.
The evaluation circuit 304 may be configured to determine blood pressure information of the patient using the heart sound information. In an example, the S2 information may be used to determine blood pressure information. The relationship between S2 and blood pressure is affected by contractility. Accordingly, the evaluation circuit 304 may be configured to determine blood pressure information using the heart sound information (e.g., the S2 information) and the determined indication of cardiac contractility (e.g., determined using the S1 information).
For example, the evaluation circuit 304 may use the S1 information to determine a specified range of contractility, or use the specified range of S1 information to determine an indication of contractility (e.g., an increase in the S1 value or the S1 value greater than an average or median S1 value or threshold, such as a median S1 value increased by 25%, etc.). In an example, if the indication of contractility is below or within a specified value or range of values (e.g., an S1 value for a cardiac cycle or cardiac cycles), the heart sound information (e.g., an S2 value for the cardiac cycle or cardiac cycles, respectively) may be used to determine blood pressure information. Conversely, if the indication of contractility is above or beyond the specified value or range of values (e.g., for a cardiac cycle or multiple cardiac cycles), the blood pressure information (e.g., for the cardiac cycle or corresponding multiple cardiac cycles) may be ignored or not determined.
Fig. 4 illustrates an example method 400 of determining blood pressure information using an indication of determined contractility. At 402, physiological information of a patient may be received, for example, using a signal receiving circuit of a flow system or an external system. The physiological information may include heart sound information, one or more other types of physiological information (e.g., respiration, heart rate, impedance, electrocardiographic information, etc.), or a combination thereof, such as detected using one or more sensors of one or more flow devices (e.g., heart sound sensors, impedance sensors, electrodes, etc.). The signal receiving circuit may be coupled (e.g., communicatively coupled) to the one or more sensors, or the signal receiving circuit may be configured to receive physiological information from one or more external systems coupled to the one or more sensors.
At 404, an indication of the patient's cardiac contractility may be determined using the received physiological information (e.g., using an evaluation circuit of the flow system or an external system). In an example, cardiac sound information (e.g., S1 information of the patient) may be used to determine an indication of cardiac contractility. In other examples, other received physiological information or combinations of received physiological information (e.g., S1 information, heart rate information, etc.) may be used to determine the indication of contractility.
At 406, the heart sound information (e.g., the S2 information) and the determined indication of cardiac contractility (e.g., the S1 information) may be used to determine a blood pressure of the patient. In an example, the blood pressure information may be determined using a range of the S2 information or the S1 information at a specified value. In an example, the specified value or range of S1 information may correspond to a level of cardiac contractility. For example, if the S1 information indicates that the contractility of the heart is high, such as using a value of the S1 information that is above a threshold (e.g., 25% above the mean or median, etc.). In certain examples, one or more other thresholds may be used to correspond to the determination of cardiac contractility, the thresholds being higher than or normal ranges with respect to the median or mean, whether for patients or on a population basis.
Fig. 5 illustrates an
In an example, the blood pressure measured at 508 may be used to determine or adjust a therapy, such as part of a closed loop system. If the measured blood pressure is within the range or above or below the threshold, the therapy may be continued, initiated or adjusted depending on the therapy or treatment. If the measured blood pressure is not within the range or above or below the threshold, the therapy can be discontinued, initiated, or adjusted depending on the therapy or treatment.
Fig. 6 illustrates a block diagram of an
As described herein, examples may include, or be operated by, logic or a plurality of components or mechanisms in the
In alternative embodiments, the
The machine (e.g., computer system) 600 may include a hardware processor 602 (e.g., a Central Processing Unit (CPU), a Graphics Processing Unit (GPU), a hardware processor core, or any combination thereof), a
The
The term "machine-readable medium" may include any medium that is capable of storing, encoding or carrying instructions for execution by the
The
The above-identified drawing figures illustrate various embodiments. One or more features from one or more of these embodiments may be combined to form further embodiments. The method examples described herein may be machine or computer-implemented, at least in part. Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device or system to perform the methods described in the above examples. Implementations of such methods may include code, such as microcode, assembly language code, a high-level language code, and so forth. Such code may include computer readable instructions for performing various methods. The code may form part of a computer program product. Further, the code can be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.
The foregoing detailed description is intended to be illustrative rather than limiting. The scope of the disclosure should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
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