Alarm status determination based on chemical information

Abstract

Systems and methods for determining an alarm status for a health index using the health index and one or more pieces of chemical information are disclosed. The chemical information may include potassium levels, creatinine levels, etc. The determined alert status may be provided to a user or process.

Description

[0001] Priority requirements

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 604,054, filed November 29, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0003] This document generally pertains to medical devices, and more specifically, to the use of health indices and chemical information to determine or adjust alarm states. Background Technology

[0004] Ambulatory medical devices (AMDs), including implantable, subcutaneous, wearable, or other medical devices, can monitor, detect, or treat various conditions, including heart failure (HF) and atrial fibrillation (AF). AMDs may include sensors that sense physiological information from a patient, and one or more circuits that use the sensed physiological information to detect one or more physiological events or transmit the sensed physiological information or detected physiological events to one or more remote devices. Frequent patient monitoring can provide early detection of deteriorating patient conditions, including worsening heart failure or atrial fibrillation.

[0005] Accurately identifying patients or patient groups at high risk of future adverse events allows for control over the mode or feature selection or resource management of one or more mobile medical devices. It also enables control over notifications or messages sent to various users associated with a specific patient or patient group within connected systems, organizing or scheduling doctor-patient contacts or treatments, or preventing or reducing patient hospitalizations. Properly identifying and safely managing the risk of patient deterioration can avoid unnecessary medical interventions, extend the lifespan of mobile medical devices, and reduce healthcare costs. Summary of the Invention

[0006] Systems and methods are disclosed for determining alarm states for health indices using a health index and one or more chemical information items. The chemical information may include potassium levels, creatinine levels, etc. The determined alarm state can be provided to a user or process.

[0007] Examples of the subject (e.g., a medical device system) may include a signal receiver circuit configured to receive physiological information of a patient; and an evaluation circuit configured to determine a patient’s health index as a function of the received physiological information, wherein the signal receiver circuit is configured to receive the patient’s chemical information, and wherein the evaluation circuit is configured to use the determined health index and the received chemical information to determine the patient’s alarm state.

[0008] In the example, the health index includes a comprehensive health index, and the evaluation circuit is configured to determine the patient's comprehensive health index as a function of at least two features of the received physiological information.

[0009] In this example, the example can be combined with any one or more of the preceding examples. In order to determine the patient's alarm state, the evaluation circuit is configured to determine the patient's first alarm state using the determined health index value and health index alarm threshold, and to determine the second alarm state based on the determined first alarm state and the received patient chemical information.

[0010] In this example, the example can be combined with any one or more of the preceding examples. The second alarm state is one of several guidelines-guided medical treatment (GDMT) alarm states associated with treatment adjustments, wherein the evaluation circuit is configured to provide the output of the determined alarm state to the user interface for display to the user, or to the control circuit to control or adjust the process or function of the medical device system.

[0011] In this example, the example can be combined with any one or more of the preceding examples. The evaluation circuit is configured to use received chemical information to determine a first chemical parameter and a second chemical parameter, wherein the received chemical information includes at least one of the patient's potassium information or creatinine information, wherein the first chemical parameter and the second chemical parameter include an indication of a relatively high or low value of the received chemical information relative to one or more thresholds, wherein, in order to determine a first alarm state, the evaluation circuit is configured to determine that the value of the determined health index is higher than a health index alarm threshold, and wherein the evaluation circuit is configured to determine a second alarm state based on the determined first alarm state and at least one of the determined first chemical parameter and the second chemical parameter.

[0012] In this example, the example can be combined with any one or more of the preceding examples. Determining the second alarm state includes determining that the patient's potassium information is below the potassium threshold and that the patient's creatinine information is below the creatinine threshold, and wherein the evaluation circuit is configured to provide a control signal to provide or increase a potassium-sparing diuretic in response to determining the second alarm state.

[0013] In this example, the example can be combined with any one or more of the preceding examples. Determining the second alarm state includes determining that the patient's potassium information is above the potassium threshold and the patient's creatinine information is below the creatinine threshold, and wherein the evaluation circuit is configured to provide a control signal to provide or increase a thiazide diuretic in response to determining the second alarm state.

[0014] In this example, the example can be combined with any one or more of the preceding examples to determine the second alarm state, which includes determining that the patient’s creatinine information is higher than the creatinine threshold, and wherein the evaluation circuit is configured to provide a control signal to provide or increase a vasodilator in response to determining the second alarm state.

[0015] In this example, the example can be combined with any one or more of the previous examples, the health index includes the heart failure index, and the health index alarm threshold includes the heart failure alarm threshold.

[0016] In this example, the example can be combined with any one or more of the preceding examples. One approach may include receiving physiological information of a patient using a signal receiver circuit, determining the patient’s health index as a function of the received physiological information using an evaluation circuit, receiving the patient’s chemical information using a signal receiver circuit, and determining the patient’s alarm state using the determined health index and the received chemical information using the evaluation circuit.

[0017] In this example, the example can be combined with any one or more of the preceding examples to determine the patient’s alarm state by using the determined health index value and health index alarm threshold to determine the patient’s first alarm state, and by determining the second alarm state based on the determined first alarm state and the received patient’s chemical information.

[0018] In this example, the example can be combined with any one or more of the preceding examples. One approach may include using evaluation circuitry to provide the output of the determined alarm state to a user interface for display to a user, or to control circuitry to control or adjust the process or function of a medical device system, wherein the second alarm state is one of a number of guidelines-guided medical treatment (GDMT) alarm states associated with treatment adjustments.

[0019] In this example, the example can be combined with any one or more of the preceding examples. One method may include using an evaluation circuit to determine a first chemical parameter and a second chemical parameter using received chemical information, wherein the received chemical information includes at least one of the patient's potassium information or creatinine information, wherein the first chemical parameter and the second chemical parameter include an indication of a relatively high or low value of the received chemical information relative to one or more thresholds, wherein determining a first alarm state includes determining that the value of the determined health index is higher than a health index alarm threshold, and wherein determining a second alarm state includes determining the second alarm state based on the determined first alarm state and at least one of the determined first chemical parameter and the second chemical parameter.

[0020] In this example, the example can be combined with any one or more of the preceding examples. Determining the second alarm state includes determining that the patient's potassium information is below the potassium threshold and that the patient's creatinine information is below the creatinine threshold, and in response to determining the second alarm state, providing a control signal to provide or increase a potassium-sparing diuretic.

[0021] In this example, the example can be combined with any one or more of the preceding examples. One approach may include determining a second alarm state, which includes determining that the patient’s potassium information is above a potassium threshold and the patient’s creatinine information is below a creatinine threshold, and in response to determining the second alarm state, providing a control signal to provide or increase a thiazide diuretic.

[0022] In this example, which can be combined with any one or more of the preceding examples, the medical device system may include a signal receiver circuit configured to receive physiological information of a patient; and an evaluation circuit configured to determine a patient’s health index as a function of the received physiological information, wherein the signal receiver circuit is configured to receive chemical information of the patient, and wherein the evaluation circuit is configured to use the determined health index and the received chemical information to determine the patient’s alarm state.

[0023] In the example, the health index includes a comprehensive health index, and the evaluation circuit is configured to determine the patient's comprehensive health index as a function of at least two features of the received physiological information.

[0024] In this example, the example can be combined with any one or more of the preceding examples. In order to determine the patient's alarm state, the evaluation circuit is configured to determine the patient's first alarm state using the determined health index value and health index alarm threshold, and to determine the second alarm state based on the determined first alarm state and the received patient chemical information.

[0025] In this example, the example can be combined with any one or more of the preceding examples. The second alarm state is one of several guidelines-guided medical treatment (GDMT) alarm states associated with treatment adjustments, wherein the evaluation circuit is configured to provide the output of the determined alarm state to the user interface for display to the user, or to the control circuit to control or adjust the process or function of the medical device system.

[0026] In this example, the example can be combined with any one or more of the preceding examples. The evaluation circuit is configured to use received chemical information to determine a first chemical parameter and a second chemical parameter, wherein the received chemical information includes at least one of the patient's potassium information or creatinine information, wherein the first chemical parameter and the second chemical parameter include an indication of a relatively high or low value of the received chemical information relative to one or more thresholds, wherein, in order to determine a first alarm state, the evaluation circuit is configured to determine that the value of the determined health index is higher than a health index alarm threshold, and wherein the evaluation circuit is configured to determine a second alarm state based on the determined first alarm state and at least one of the determined first chemical parameter and the second chemical parameter.

[0027] In this example, the example can be combined with any one or more of the preceding examples. Determining the second alarm state includes determining that the patient's potassium information is below the potassium threshold and that the patient's creatinine information is below the creatinine threshold, and wherein the evaluation circuit is configured to provide a control signal to provide or increase a potassium-sparing diuretic in response to determining the second alarm state.

[0028] In this example, the example can be combined with any one or more of the preceding examples. Determining the second alarm state includes determining that the patient's potassium information is above the potassium threshold and the patient's creatinine information is below the creatinine threshold, and wherein the evaluation circuit is configured to provide a control signal to provide or increase a thiazide diuretic in response to determining the second alarm state.

[0029] In this example, the example can be combined with any one or more of the preceding examples to determine the second alarm state, which includes determining that the patient’s creatinine information is higher than the creatinine threshold, and wherein the evaluation circuit is configured to provide a control signal to provide or increase a vasodilator in response to determining the second alarm state.

[0030] In this example, the example can be combined with any one or more of the previous examples, the health index includes the heart failure index, and the health index alarm threshold includes the heart failure alarm threshold.

[0031] In this example, the example can be combined with any one or more of the preceding examples. One approach includes using a signal receiver circuit to receive physiological information of a patient, using an evaluation circuit to determine the patient's health index as a function of the received physiological information, using a signal receiver circuit to receive the patient's chemical information, and using the evaluation circuit to determine the patient's alarm state using the determined health index and the received chemical information.

[0032] In this example, the example can be combined with any one or more of the preceding examples, the health index includes a comprehensive health index, and determining the health index includes determining the patient's comprehensive health index as a function of at least two features of the received physiological information.

[0033] In this example, the example can be combined with any one or more of the preceding examples to determine the patient’s alarm state by using the determined health index value and health index alarm threshold to determine the patient’s first alarm state, and by determining the second alarm state based on the determined first alarm state and the received patient’s chemical information.

[0034] In this example, the example can be combined with any one or more of the preceding examples. The method includes using evaluation circuitry to provide the output of the determined alarm state to a user interface for display to a user, or to control circuitry to control or adjust the process or function of a medical device system, wherein the second alarm state is one of a number of guidelines-guided medical treatment (GDMT) alarm states associated with treatment adjustments.

[0035] In this example, the example can be combined with any one or more of the preceding examples. The method includes using an evaluation circuit to determine a first chemical parameter and a second chemical parameter using received chemical information, wherein the received chemical information includes at least one of the patient's potassium information or creatinine information, wherein the first chemical parameter and the second chemical parameter include an indication of a relatively high or low value of the received chemical information relative to one or more thresholds, wherein determining a first alarm state includes determining that the value of a determined health index is higher than a health index alarm threshold, and wherein determining a second alarm state includes determining a second alarm state based on the determined first alarm state and at least one of the determined first chemical parameter and the second chemical parameter.

[0036] In this example, the example can be combined with any one or more of the preceding examples. Determining the second alarm state includes determining that the patient's potassium information is below the potassium threshold and that the patient's creatinine information is below the creatinine threshold, and in response to determining the second alarm state, providing a control signal to provide or increase a potassium-sparing diuretic.

[0037] In this example, the example can be combined with any one or more of the preceding examples. Determining the second alarm state includes determining that the patient's potassium information is above the potassium threshold and the patient's creatinine information is below the creatinine threshold, and in response to determining the second alarm state, providing a control signal to provide or increase a thiazide diuretic.

[0038] In this example, the example can be combined with any one or more of the preceding examples. Determining the second alarm state includes determining that the patient's creatinine information is higher than the creatinine threshold, and in response to determining the second alarm state, providing a control signal to provide or increase a vasodilator.

[0039] In this example, the example can be combined with any one or more of the previous examples, the health index includes the heart failure index, and the health index alarm threshold includes the heart failure alarm threshold.

[0040] In the example, the system or apparatus may optionally combine any part or combination of any one or more of the above examples to include "means for..." performing any part of any one or more of the functions or methods of the above examples, or at least one "non-transient machine-readable medium" including instructions that, when executed by a machine, cause the machine to perform any part of any one or more of the functions or methods of the above examples.

[0041] The present invention is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive interpretation of this disclosure. Detailed descriptions are included to provide further information regarding this patent application. Other aspects of this disclosure will be apparent to those skilled in the art upon reading and understanding the following detailed descriptions and viewing the drawings that form a part thereof, and none of these should be construed in a limiting sense. Attached Figure Description

[0042] In the drawing, it is not necessarily drawn to scale, and similar numbers can describe similar parts in different views. Similar numbers with different letter suffixes can represent different instances of similar parts. Figure 1 The various embodiments discussed in this document are shown by way of example rather than by way of limitation.

[0043] Figure 1 An example medical device system is shown.

[0044] Figure 2 An example patient management system is shown.

[0045] Figure 3 An example method for using chemical information to determine alerts for health indicators is shown.

[0046] Figure 4 An example method for using chemical information to determine a second alert for health indicators is shown.

[0047] Figure 5 An example implantable medical device (IMD) electrically coupled to the heart is shown.

[0048] Figure 6 A block diagram of an example machine on which any one or more of the techniques discussed in this article can be executed is shown. Detailed Implementation

[0049] Mobile medical devices may include or be configured to receive physiological information from one or more sensors located inside, on, or near a patient's body. The patient's physiological information may, among others, include one or more of the following: electrical information, such as cardiac electrical information (e.g., heart rate, heart rate variability, etc.), impedance information, temperature information, and in some examples, respiratory information (e.g., respiratory rate, respiratory volume (tidal volume), etc.); mechanical information, such as cardiac acceleration information (e.g., cardiac vibration information, pressure waveform information, heart sound information, endocardial acceleration information, acceleration information, activity information, posture information, etc.), body activity information (e.g., activity, stepping, etc.), posture or position information, pressure information, plethysmography information, and in some examples, respiratory information; chemical information; or other physiological information of the patient.

[0050] In some examples, one or more health indices can be determined as a function of different physiological information of a patient or various combinations thereof. Health indices can include single-feature health indices determined using a single characteristic or measure of a single type of physiological information, or composite health indices determined solely using combinations of physiological information, such as two or more individual characteristics from different physiological measures. For example, while respiratory rate and tidal volume are both respiratory information, they are individual characteristics of respiratory information, making it possible to determine a composite health index using only respiratory rate and tidal volume. In contrast, single-feature health indices can be determined using respiratory information, such as trends or measures of tidal volume alone.

[0051] In some examples, the health index can be a device-based index, such as one determined using physiological information detected from the patient, without requiring input of separate clinical information about the patient, such as clinician diagnosis or risk assessment, patient history, patient age, comorbidities, previous hospitalizations, and type of implanted device. In other examples, the health index can be a combination of device-based and clinically-based mortality risk indices, including or taking into account clinical information about the patient, such as clinician diagnosis or risk assessment, patient history, patient age, comorbidities, previous hospitalizations, and type of implanted device. In these examples, different combinations of clinical information can be determined separately.

[0052] An example of a comprehensive health index is HeartLogic. TM Index, HeartLogic during alert time TMOr one or more other comprehensive measurements or their measures. HeartLogic TM The index is a comprehensive measurement of a patient's electrophysiological information from multiple motion sensors, including S1 and S3 heart sounds, thoracic impedance, activity information, respiratory information, and nighttime heart rate (nHR). It can indicate the state of heart failure, the risk of heart failure events, or the deterioration of the patient's heart failure state or the risk of heart failure events over time. HeartLogic is in the alarm period. TM It is HeartLogic TM A measure of the time the index is above the alarm threshold.

[0053] In some examples, HeartLogic TM The index can be determined using different combinations or weights of electrophysiological information, including one or more of S1 and S3 heart sounds, thoracic impedance, activity information, rapid shallow breathing index (RSBI), respiratory rate, and nocturnal heart rate (nHR). In some examples, HeartLogic TM Different combinations or weights of the indices can be adjusted or determined based on a risk stratifier. In some examples, the risk stratifier can be determined as different combinations of physiological information, including one or more of S3, respiratory rate, and activity time (e.g., the amount of time spent at a specific activity level above the patient's average activity level or a specific threshold).

[0054] For example, if the risk stratifier is low or below the first threshold, then HeartLogic TM The index can be determined using a first combination of physiological information. If the risk stratification is high, or above a second threshold, then HeartLogic... TM The index can be determined using a first combination of physiological information and a second combination of physiological information (including additional information compared to that included in the first combination). If the risk stratifier falls between the first and second thresholds, then HeartLogic... TM The index can be determined using one or more indicators or components of the first and second combinations, or using the first and second combinations (but the second combination has less weight than when the risk stratifier is above the second threshold (e.g., using a smaller second combination)).

[0055] In the example, HeartLogic TMIndices and alert times may include detection of worsening heart failure or physiological events, including risk indications or stratification, such as those disclosed in U.S. Patent No. 9,968,266, co-assigned by An et al., entitled "RISK STRATIFICATIONBASED HEART FAILURE DETECTION ALGORITHM," or in U.S. Patent No. 9,622,664, co-assigned by An et al., entitled "METHODS AND APPARATUS FOR DETECTING HEART FAILURE DECOMPENSATION EVENT AND STRATIFYING THE RISK OF THE SAME," or in U.S. Patent No. 10,660,577, co-assigned by Thakur et al., entitled "SYSTEMS AND METHODS FOR DETECTING WORSENING HEART FAILURE," or in U.S. Patent No. 10,660,577, co-assigned by An et al., entitled "HEART FAILURE PATIENT." The disclosures in U.S. Patent Application No. 2014 / 0031643 entitled “STRATIFICATION”, or in U.S. Patent No. 10,085,696 entitled “DETECTION OF WORSENING HEART FAILURE EVENTSUSING HEART SOUNDS”, co-assigned Thakur et al., each of which is incorporated herein by reference in its entirety, including their disclosures on detection of heart failure and worsening heart failure, detection of heart failure risk indicators, and their stratification, etc.

[0056] Implantable and mobile medical devices often include one or more accelerometer sensors and corresponding processing circuitry to determine and monitor patient acceleration information, such as cardiac vibration information (e.g., heart sounds, heart wall motion, etc.) associated with blood flow or movement in the heart or the patient's vascular system, patient body activity or location information (e.g., patient posture, activity, etc.), respiratory information (e.g., respiratory rate, phase, breath sounds, etc.), etc.

[0057] Heart sounds are recurring mechanical signals associated with the vibrations of the heart or accelerations from blood flow through the heart or other cardiac movements during each cardiac cycle, and can be separated and classified according to the activities associated with these vibrations, accelerations, movements, pressure waves, or blood flow. Heart sounds comprise four main characteristics: the first to the fourth heart sounds (S1 to S4, respectively). The first heart sound (S1) is a vibration produced by the heart during the closure of the atrioventricular (AV), mitral, and tricuspid valves, and during the opening of the aortic valve at the onset of systole or ventricular systole. The second heart sound (S2) is a vibration produced by the heart during the closure of the aortic and pulmonary valves at the onset of diastole or ventricular diastole. The third and fourth heart sounds (S3, S4) are related to the filling pressure of the left ventricle during diastole. An abrupt cessation of early diastolic filling can result in the third heart sound (S3). Vibrations caused by atrial kicks can result in the fourth heart sound (S4). The closure of valves in the heart and changes in blood flow and pressure can cause acceleration, vibration, or movement of the heart wall, which can be detected using an accelerometer or microphone, thus providing an output referred to in this paper as cardiac acceleration information.

[0058] Respiratory information may include, among other things, a patient's respiratory rate (RR), tidal volume (TV), rapid shallow breathing index (RSBI), or other respiratory information. Respiratory rate is a measure of the rate of a patient's inspiratory and expiratory breathing, typically measured as breaths per minute. Tidal volume is a summary measure of respiratory changes, such as those detected using measured changes in thoracic impedance. RSBI is the ratio of a measured respiratory rate to a patient's relative tidal volume. nHR is a measure of a patient's heart rate (HR) at night, related to sensing patient sleep or using a preset or selectable time of day corresponding to patient sleep. In some examples, a patient's respiratory information can be determined using changes in impedance information and thus can be considered electrophysiological information, but distinct from cardiac electrical information. In other examples, a patient's respiratory information can be determined using changes in activity or acceleration information and thus can be considered mechanophysiological information.

[0059] As described herein, physiological values ​​or characteristics may include one or more different measures of the rate, amplitude, energy, etc., of different physiological information over one or more time periods (such as representative daily values). For example, heart sound values ​​may be determined for each heart sound (e.g., the first heart sound (S1) through the fourth heart sound (S4), etc.) and may include an indication of the amplitude or energy of a specific heart sound in a particular cardiac cycle, or a representation of the number of cardiac cycles of a patient over a particular time period. Daily values ​​may be determined representing the patient's average daily values, corresponding to awake time or a 24-hour period, etc. Respiratory values ​​may include, among other things, the average or median respiratory rate, binned values ​​of the rate, and representative values ​​of specific rate bins, etc. Heart rate values ​​may include the average nocturnal heart rate, minimum nocturnal heart rate, etc.

[0060] Activity information may include measurements of the patient's activity, such as those detected using an accelerometer, posture sensor, pedometer, or one or more other activity sensors associated with the mobile medical device. Impedance information may include, among other things, the patient's thoracic impedance information, such as measurements of impedance across the patient's chest cavity from one or more electrodes associated with the mobile medical device (e.g., one or more leads of an implantable medical device located near the patient's heart and the housing of the implantable medical device implanted subcutaneously in the patient's chest cavity, one or more external leads on the patient's body, etc.). In other examples, impedance information may include one or more other impedance measurements associated with the patient's chest cavity, or otherwise indicate the patient's thoracic impedance.

[0061] Temperature information may include the patient's internal temperature at a mobile medical device (such as one implanted in the patient's chest cavity), or one or more other temperature measurements taken at a specific location on the patient. Temperature information can be detected using a temperature sensor (such as one or more circuits or electronic components having electrical properties that change with temperature). The temperature sensor may include a sensing element located on, within, or on the mobile medical device, configured to determine a temperature indicating the patient's temperature at the location of the mobile medical device.

[0062] In contrast to and separate from the electrophysiological information discussed above, chemical information may include information about one or more chemical properties of a patient's blood, interstitial space (e.g., spaces between cells, such as those including interstitial fluid), or other tissues (e.g., muscle tissue, adipose tissue, organ tissue, etc.), such as information indicating or including one or more of glucose levels, pH levels, dissolved gas levels (e.g., oxygen, carbon dioxide, carbon monoxide, etc.), electrolyte levels (e.g., sodium, potassium, calcium, etc.), organic compound levels (e.g., lactate, cholesterol, hemoglobin, creatinine, etc.), or biological compound levels (e.g., enzymes, antibodies, receptors, etc.). Chemical information can be measured by one or more of electrical sensors, mechanical sensors, electrochemical sensors, biosensors (e.g., enzyme biosensors, etc.), ion-selective electrode sensors, optical sensors, etc. In the example, chemical information may include potassium information (e.g., one or more of interstitial potassium information, serum potassium information, etc.), creatinine information (e.g., one or more of interstitial creatinine information, serum creatinine information, etc.) or combinations thereof.

[0063] In some examples, interstitial chemical information, such as one or more chemical levels in the interstitial space (e.g., the space between one or more of connective tissue, muscle fibers, nerve tissue, etc.) or interstitial fluid, can indicate serum chemical information. For example, potassium can move between cells or tissues and interstitial fluid (e.g., changes in interstitial potassium levels may accompany or reflect changes in serum potassium levels, or vice versa), such that serum potassium chemical information can include interstitial potassium. In some examples, one of the interstitial or serum chemical information may lead or lag behind the other, such that a change in one that could indicate a worsening patient condition can be detected before the other. In one example, interstitial potassium information may lead serum potassium information as an indicator of electrolyte imbalance.

[0064] The inventors have recognized, among other things, systems and methods that use chemical information to adjust or determine a patient's health index alert status (such as to improve the sensitivity or specificity of health index alert status determination), reduce false positive alert status determination, alert status transitions or adjustments, or otherwise reduce the storage or transmission of physiological information associated with false positive alert status determination or transitions associated with false positive alert status determination, and the associated power and processing resources. In examples, the system may determine one or more chemical pieces of information and use the chemical information to determine, adjust, or include additional information about the patient's alert status or determined condition.

[0065] In some examples, the system may have alarm states (e.g., in alarm state, out of alarm state, priority alarm state, etc.). Alarm states can be provided to the patient, clinician, or one or more other users or devices associated with the patient. Alarm states can use health indices (such as HeartLogic). TM An index and one or more features of the received chemical information are determined. In the example, the health index may be determined using one or more features based on the received chemical information, and therefore an alarm state determined based on the health index may be an alarm state based on the health index and the received chemical information. In the example, the health index may not include any features based on the received chemical information, but instead include physiological information that does not include the received chemical information, and therefore an alarm state based on the health index may not be an alarm state based on the health index and the received chemical information.

[0066] In the example, the health index may have a value (e.g., a numerical value), and this value may be compared to one or more thresholds to determine the alarm state of the system. The evaluation circuitry may be configured to compare the health index to one or more health index alarm thresholds (e.g., a single health index alarm threshold, a first health index alarm threshold, a second health index alarm threshold, etc.) to determine the patient's first alarm state. In the example, the health index may have a numerical value, where a higher value indicates a worse health condition for the patient, and a lower value indicates a better health condition. The health index alarm threshold may be a high threshold that triggers an alarm state if the health index value exceeds the health index alarm threshold.

[0067] The health index alarm threshold can be a fixed value, or it can be an adaptive threshold that varies based on one or more factors. In the example, the health index alarm threshold can be fixed, but the health index value can be based in part on one or more relative factors (e.g., based on measurements from the patient over the past 30 days, rather than on a fixed value). This could result in the patient being in an alarm state threshold condition being relative, even if the health index alarm threshold is fixed.

[0068] The system's first alarm state can be determined by comparing a health index value with a health index alarm threshold. If the health index includes one or more features generated using chemical information or determined using it, the first alarm state may be at least partially based on the received chemical information; otherwise, if the health index does not include any features generated using chemical information or is not determined using it, the first alarm state may not be based on the received chemical information. The system can generate a second alarm state based on the determined first alarm state and one or more features of the received chemical information. For example, the system can determine the second alarm state by adjusting the determined first alarm state (e.g., changing from an alarm state to an off-alarm state, changing from an alarm state to a priority alarm state, maintaining the first alarm state, etc.), by enhancing the determined first alarm state (e.g., appending one or more additional pieces of information to the alarm state), etc. In the example, the system can determine the second alarm state based on one or more of the following: the determined first alarm state, one or more features of the received chemical information, the health index (e.g., a health index value), one or more other received physiological information, one or more features used in the health index, historical values ​​of one or more features, etc.

[0069] Enhancing the primary alert status may include providing clinicians with one or more additional pieces of information. For example, the identified secondary alert status may provide the physician with instructions to perform one or more actions (e.g., recommending a drug or drug class from multiple options, suggesting optimized guideline-directed medical therapy (GDMT), etc.). The identified secondary alert status may be provided to a user interface for display to the user, or to control circuitry to control or adjust the system's processes or functions. In the example, the identified secondary alert status may include one or more instructions or recommendations to administer or provide a class of drugs or instructions or recommendations related to GDMT. GDMT may provide a standard course of action to be followed in the patient's treatment. For example, GDMT may recommend administering a certain amount of drug or a rate of dose increase, etc. In the example, when received chemical information indicates one or more low potassium levels or low creatinine levels, the secondary alert status may include one or more instructions to administer or provide a potassium-sparing diuretic, or instructions to deviate from GDMT (e.g., increasing GDMT above the standard recommendation, increasing the drug dose, adjusting the rate of drug increase, etc.).

[0070] In the example, when the received chemical information indicates that one or more potassium levels are high or creatinine levels are low (such as relative to a first threshold and a second threshold), the second alert status may include one or more of the following, in conjunction with the value of a determined health index indicating the first alert status: providing an instruction to administer or provide a thiazide diuretic or providing an instruction to maintain GDMT (e.g., maintaining GDMT at the standard recommendation, maintaining GDMT at the current level, etc.).

[0071] In the example, when the received chemical information indicates that one or more potassium levels are low or creatinine levels are high, the second alarm status may include one or more of the following: providing instructions to administer or provide a vasodilator (e.g., using a vasodilator as an alternative to a diuretic, using a vasodilator in addition to a diuretic, such as in combination with a reduced diuretic dose, etc.) or providing instructions to maintain or reduce GDMT (e.g., reducing GDMT below the standard recommendation, reducing the dose of the drug, reducing the rate of increase of the drug, etc.).

[0072] In the example, when the received chemical information indicates that one or more of the potassium levels are high or the creatinine level is high, the second alarm status may include one or more of the following: providing an instruction to administer or provide an instruction to reduce GDMT.

[0073] In the example, when the received chemical information indicates that one or more potassium or creatinine are at normal levels, the second alarm status may not be given, or the second alarm status may provide an indication to follow normal guidelines (e.g., administer a diuretic and / or titrate GDMT upwards).

[0074] In some examples, the techniques described above or in this article can be used in various combinations or arrangements. For example, the combination or arrangement of the techniques described above or in this article can be selected based on patient history, clinician input, etc.

[0075] Figure 1 An example system 100 (e.g., a medical device system) is illustrated. In the example, one or more aspects of the example system 100 may be components of or communicatively coupled to a medical device, such as an implantable medical device (IMD), an insertable cardiac monitor, a mobile medical device (AMD), etc. System 100 may be configured to monitor, detect, or treat various physiological conditions of the body, such as cardiac conditions associated with a reduced ability of the heart to adequately deliver blood to the body, including heart failure, arrhythmias, asynchrony, etc., or one or more other physiological conditions, and in some examples, may be configured to provide electrical stimulation or one or more other therapies or treatments to the patient.

[0076] System 100 may include a single or multiple medical devices implanted in or otherwise positioned on or around a patient to monitor the patient’s physiological information using information from one or more sensors, such as sensor 101. In the example, sensor 101 may include one or more of the following: a respiratory sensor configured to receive respiratory information (e.g., respiratory rate, respiratory volume (tidal volume), etc.); an acceleration sensor (e.g., accelerometer, microphone, etc.) configured to receive cardiac acceleration information (e.g., cardiac vibration information, pressure waveform information, heart sound information, endocardial acceleration information, acceleration information, activity information, posture information, etc.); an impedance sensor (e.g., intrathoracic impedance sensor, transthoracic impedance sensor, pleural impedance sensor, etc.) configured to receive impedance information; a cardiac sensor configured to receive cardiac electrical information; an activity sensor configured to receive information about body movement (e.g., activity, steps, etc.); a posture sensor configured to receive posture or position information; a pressure sensor configured to receive pressure information; a volumetric sensor (e.g., photoplethysmography sensor, etc.); a chemical sensor (e.g., electrolyte sensor, pH sensor, anion gap sensor, etc.); a temperature sensor; a skin elasticity sensor; or one or more other sensors configured to receive physiological information of a patient.

[0077] Example system 100 may include signal receiver circuitry 102 and evaluation circuitry 103. Signal receiver circuitry 102 may be configured to receive physiological information from sensor 101 about a patient (or patient group). Evaluation circuitry 103 may be configured to receive information from signal receiver circuitry 102 and use the received physiological information (such as that described herein) to determine one or more parameters (e.g., physiological parameters, stratification, etc.) or existing or altered patient conditions (e.g., indications of patient dehydration, respiratory status, cardiac status (e.g., heart failure, arrhythmia), sleep apnea, etc.). Physiological information may include, among others, cardiac electrical information, impedance information, respiratory information, heart sound information, activity information, posture information, temperature information, or one or more other types of physiological information.

[0078] In some examples, evaluation circuit 103 can aggregate information from multiple sensors or devices, use information from each sensor or device individually or in combination to detect various events, update the detection status of one or more patients based on the information, and transmit messages or alarms to one or more remote devices that one or more patients have been detected, or that information has been stored or transmitted, so that one or more other processes or systems can use the stored or transmitted detection or information for one or more other checks or processes.

[0079] In some examples, such as to detect improvement or deterioration in a patient's condition, some initial assessment is often required to establish a baseline level or condition from one or more sensors or physiological information. Subsequent detections of deviations from the baseline level or condition can be used to determine whether the patient's condition has improved or deteriorated. However, in other examples, the amount of change or alteration (e.g., relative or absolute change) in physiological information over different time periods can be used to determine the risk of adverse medical events, or to predict or stratify the risk of a patient experiencing an adverse medical event (e.g., heart failure) some time after the change is detected, in conjunction with or separately from any baseline level or condition.

[0080] Changes in different physiological information can be aggregated and weighted based on one or more patient-specific stratifiers and, in some examples, compared to one or more thresholds, such as those that are clinically sensitive and specific in the target population relative to a specific condition (e.g., heart failure), and one or more specific time periods, such as daily values, short-term averages (e.g., daily values ​​aggregated over several days), long-term averages (e.g., daily values ​​aggregated over multiple short-term periods or more numbers of days (sometimes different from the number of days used for short-term averages, e.g., non-overlapping)).

[0081] System 100 may include output circuitry 104 configured to provide output to a user, or to provide output to a user via an output terminal, display, or one or more other user interfaces, including scores, trends, alarms, or other indications. In other examples, output circuitry 104 may be configured to provide output to another circuit, machine, or process (such as treatment circuitry 105, e.g., cardiac resynchronization therapy (CRT) circuitry, chemotherapy circuitry, stimulation circuitry, etc.) to control, adjust, or stop treatment by a medical device, drug delivery system, etc., or otherwise modify one or more processes or functions of one or more other aspects of the medical device system, such as one or more CRT parameters, drug delivery, dosage determination, or recommendations. In examples, treatment circuitry 105 may include one or more of stimulation control circuitry, cardiac stimulation circuitry, neural stimulation circuitry, dosage determination, or control circuitry. In other examples, treatment circuitry 105 may be controlled by evaluation circuitry 103 or one or more other circuitry. In some examples, evaluation circuit 103 may include output circuit 104, or may be configured to determine the output to be provided by output circuit 104, which may provide a signal that causes the user interface to provide output to the user based on the output determined by evaluation circuit 103.

[0082] A technical challenge exists in medical devices and systems where, in low-power monitoring modes, mobile medical devices (e.g., including IMDs) powered by one or more rechargeable or non-rechargeable batteries must make trade-offs between battery life, or, in the case of implantable medical devices with non-rechargeable batteries, the device replacement period (typically including surgery), and the sampling resolution and sampling period for processing, storing, and transmitting sensed physiological information or features or patterns within the medical device or system. Medical devices may include higher-power and lower-power modes. Physiological information, such as indications of potential adverse physiological events, can be used to transition from a low-power mode to a high-power mode. In some examples, a low-power mode may include a low-resource mode characterized by requiring less power, processing time, memory, or communication time or bandwidth (e.g., transmitting less data) than a corresponding high-power mode. A high-power mode may include a relatively high-resource mode characterized by requiring more power, processing time, memory, or communication time or bandwidth than a corresponding low-power mode. However, by the time the physiological information detected in the low-power mode indicates a possible event, valuable information has been lost and cannot be recorded in the high-power mode.

[0083] The opposite is also true, as erroneous or inaccurate determinations that trigger high-power modes unnecessarily and excessively limit the usable lifespan of some mobile medical devices. For many reasons, accurate detection and determination of physiological events, and avoiding unnecessary transitions from low-power to high-power modes, are beneficial for improving the utilization of medical device resources.

[0084] For example, a change in mode can enable higher resolution sampling or an increase in sampling frequency, or an increase in the number or type of sensors used to sense physiological information, up to and including potential events. For instance, different physiological information is often sensed using non-overlapping time periods of the same sensor, in some examples, at different sampling frequencies and power costs. In one example, heart sounds and patient activity can be detected using the same non-overlapping time periods of a single-axis or multi-axis accelerometer, at different sampling frequencies and power costs. In some examples, a shift to a high-power mode may include using an accelerometer to detect heart sounds throughout the high-power mode or at a larger percentage of the high-power mode than the corresponding low-power mode. In other examples, waveforms of medical events may be recorded, stored in long-term memory, and transmitted to a remote device for review by a clinician. In some examples, only a notification that the event has been stored is transmitted, or summary information about the event is transmitted. In response, the full event can be requested for subsequent transmission and review. However, even when events are stored but not transmitted, the resources used for storing and processing events are still used by the medical device.

[0085] Figure 2An example patient management system 200 and a portion of the environment in which the patient management system 200 may operate are shown. The patient management system 200 can perform a range of activities, including remote patient monitoring and diagnosis of disease conditions. These activities can be performed near the patient 201 (such as in the patient's home or office), via a centralized server (such as in a hospital, clinic, or doctor's office), or via a remote workstation (such as a secure wireless mobile computing device).

[0086] The patient management system 200 may include one or more medical devices, an external system 205, and a communication link 211, which provides communication between the one or more mobile medical devices and the external system 205. The one or more medical devices may include mobile medical devices (AMDs), such as implantable medical devices (IMDs) 202, wearable medical devices 203, or one or more other implantable, leadless, subcutaneous, external, wearable, or medical devices configured to monitor, sense, or detect information from the patient 201, determine physiological information about the patient 201, or provide one or more treatments to treat various conditions of the patient 201, such as one or more cardiac or non-cardiac conditions (e.g., dehydration, sleep apnea, etc.).

[0087] In one example, implantable medical device 202 may include one or more cardiac rhythm management devices implanted in a patient's chest, the device having a lead system 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 heart, chest, abdomen, or neck of the patient 201. In another example, implantable medical device 202 may include, for example, a monitor subcutaneously implanted in the chest of the patient 201, the implantable medical device 202 including a housing containing circuitry, and in some examples, one or more sensors, such as temperature sensors.

[0088] Cardiac rhythm management devices, such as insertable cardiac monitors, pacemakers, defibrillators, or cardiac resynchronizers, include implantable or subcutaneous devices with hermetically sealed housings configured for implantation in a patient's chest. Cardiac rhythm management devices may include one or more leads to position one or more electrodes or other sensors at various locations in or near the heart, such as one or more atria or ventricles. Thus, cardiac rhythm management devices may include an aspect located subcutaneously but close to the patient's distal skin, and an aspect located near one or more organs of the patient, such as leads or electrodes. Separate from or other than the leads, one or more electrodes or other sensors may include one or more electrodes or other sensors (e.g., pressure sensors, accelerometers, gyroscopes, microphones, etc.) powered by a power source within the cardiac rhythm management device. The leads, the cardiac rhythm management device, or combinations thereof, and one or more electrodes or other sensors may be configured to detect physiological information from the patient or to provide one or more treatments or stimulations to the patient.

[0089] Implantable devices may additionally or separately include leadless cardiac pacemakers (LCPs), small (e.g., smaller than conventional implantable cardiac rhythm management devices, having a volume of about 1 cc in some examples), self-contained devices comprising one or more sensors, circuitry, or electrodes configured to monitor physiological information from the heart (e.g., heart rate, etc.), detect cardiac-associated physiological conditions (e.g., tachycardia), or deliver one or more therapies or stimuli to the heart without the complications of conventional leaded or implantable cardiac rhythm management devices (e.g., required incisions and pockets, complications associated with lead placement, breakage, or displacement, etc.). In some examples, leadless pacemakers may have more limited power and processing capabilities than conventional cardiac rhythm management devices; however, multiple leadless pacemakers may be implanted in or around the heart to detect physiological information from one or more chambers of the heart, or to deliver one or more therapies or stimuli to one or more chambers of the heart. Multiple leadless pacemakers may communicate between themselves or one or more other implantable or external devices.

[0090] The implantable medical device 202 may include assessment circuitry configured to detect or determine specific physiological information of the patient 201, or to determine one or more conditions, or to provide information or alerts to users such as the patient 201 (e.g., a patient), a clinician, or one or more other caregivers or processes, as described herein. The implantable medical device 202 may alternatively or additionally be configured as a treatment device, configured to treat one or more medical conditions of the patient 201. Treatment may be delivered to the patient 201 via a lead system and associated electrodes or using one or more other delivery mechanisms. Treatment may include delivering one or more medications to the patient 201, such as using one or more of the implantable medical device 202 or other mobile medical devices. In some examples, treatment may include a CRT for correcting asynchrony in patients with heart failure and improving cardiac function in patients with heart failure. In other examples, the implantable medical device 202 may include a medication delivery system, such as a medication infusion pump, to deliver medications to the patient for managing arrhythmias or complications arising from arrhythmias, hypertension, hypotension, or one or more other physiological conditions. In other examples, the implantable medical device 202 may include one or more electrodes configured to stimulate the patient’s nervous system or to provide stimulation to the muscles of the patient’s airway, etc.

[0091] Wearable medical device 203 may include one or more wearable or external medical sensors or devices (e.g., automatic external defibrillator (AED), Holter monitor, patch-based device, smartwatch, smart accessory, wrist or finger-worn medical device, such as finger-based photoplethysmography sensor, etc.).

[0092] External system 205 may include dedicated hardware / software systems, such as a programmer, a remote server-based patient management system, or alternatively, a software-defined system primarily running on a standard personal computer. External system 205 may manage patient 201 via implantable medical device 202 or one or more other mobile medical devices connected to external system 205 via communication link 211. In other examples, implantable medical device 202 may be connected to wearable medical device 203, or wearable medical device 203 may be connected to external system 205 via communication link 211. This may include, for example, programming implantable medical device 202 to perform one or more of the following: acquiring physiological data, performing at least one self-diagnostic test (such as for device operating status), analyzing physiological data, or optionally delivering or adjusting treatment for patient 201. Additionally, external system 205 may send or receive information from implantable medical device 202 or wearable medical device 203 via communication link 211. Examples of information may include real-time or stored physiological data from patient 201, diagnostic data such as detection of patient hydration status, hospitalization, response to treatment delivered to patient 201, or device operating status (e.g., battery status, lead impedance, etc.) of implantable medical device 202 or wearable medical device 203. Communication link 211 may be an inductive telemetry link, a capacitive telemetry link, or a radio-frequency (RF) telemetry link, or wireless telemetry based on standards such as “Strong” Bluetooth or IEEE 502.11 Wireless Fidelity “Wi-Fi”. Other configurations and combinations of patient data source docking are possible.

[0093] External system 205 may include an external device 206 located near one or more mobile medical devices, and a remote device 208 located relatively far from the one or more mobile medical devices, communicating with external device 206 via communication network 207. Examples of external device 206 may include a medical device programmer. Remote device 208 may be configured to evaluate collected patient or patient information and provide alarm notifications, among other possible functions. In an example, remote device 208 may include a centralized server acting as a central hub for storing and analyzing collected data from multiple different sources. The combination of information from multiple sources may be used to make determinations and updates to individual patient status, or to adjust one or more alarms or determinations for one or more other patients. The server may be configured as a single, multiple, or distributed computing and processing system. Remote device 208 may receive data from multiple patients. Data may be collected by one or more mobile medical devices, in addition to other data acquisition sensors or devices associated with patient 201. The server may include a memory device to store data in a patient database. The server may include alarm analyzer circuitry to evaluate the collected data to determine whether specific alarm conditions are met. The fulfillment of alarm conditions can trigger the generation of alarm notifications, such as those provided by one or more human-perceptible user interfaces. In some examples, alarm conditions may be evaluated alternatively or additionally by one or more mobile medical devices, such as implantable medical devices. For example, alarm notifications may include web page updates, telephone or pager calls, emails, SMS messages, text or "instant" messages, as well as messages to patients and simultaneous direct notifications to emergency services and clinicians. Other alarm notifications are possible. The server may include alarm priority ordering circuitry configured to prioritize alarm notifications. For example, alarms for detected medical events may be prioritized using a similarity metric between physiological data associated with a detected medical event and physiological data associated with historical alarms.

[0094] Remote device 208 may additionally include one or more locally configured clients or remote clients securely connected to the server via communication network 207. Examples of clients may include personal desktop computers, laptops, mobile devices, or other computing devices. System users, such as clinicians or other qualified medical professionals, can use the clients to securely access stored patient data aggregated in a database on the server and select and prioritize patients and alerts for healthcare provisioning. In addition to generating alert notifications, remote device 208, including the server and interconnected clients, can also execute follow-up protocols by sending follow-up requests to one or more mobile medical devices, or by sending messages or other communications as compliance notifications to patients 201 (e.g., patients), clinicians, or authorized third parties.

[0095] The communication network 207 can provide wired or wireless interconnection. In this example, the communication network 207 may be based on the 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.

[0096] One or more of external devices 206 or remote devices 208 may output detected medical events to system users, such as patients or clinicians, or to a process including, for example, an instance of a computer program executable in a microprocessor. In examples, this process may include automatically generating recommendations for antiarrhythmic treatment, or recommendations for further diagnostic tests or treatments. In examples, external device 206 or remote device 208 may include a corresponding display unit for displaying physiological or functional signals, or alarms, warnings, emergency calls, or other forms of alerts to signal the detection of an arrhythmia. In some examples, external system 205 may include an external data processor configured to analyze physiological or functional signals received by one or more mobile medical devices and confirm or deny the detection of an arrhythmia. Computationally intensive algorithms, such as machine learning algorithms, may be implemented in the external data processor to retrospectively process data to detect cardiac arrhythmias.

[0097] One or more portions of a mobile medical device or external system 205 may be implemented using hardware, software, firmware, or a combination thereof. One or more portions of a mobile medical device or external system 205 may be implemented using dedicated circuitry, which may be constructed or configured to perform one or more functions, or may be implemented using general-purpose circuitry, which may be programmed or otherwise configured to perform one or more functions. Such general-purpose circuitry may include a microprocessor or a portion thereof, a microcontroller or a portion thereof, or programmable logic circuitry, memory circuitry, network interfaces, and various components for interconnecting these components. For example, among others, a “comparator” may include an electronic circuit comparator that may be constructed to perform a specific function of comparing two signals, or a comparator may be implemented as part of a general-purpose circuitry that may be driven by code instructing a portion of the general-purpose circuitry to perform a comparison between two signals. A “sensor” may include electronic circuitry configured to receive information and provide an electronic output representing such received information.

[0098] Treatment device 210 can be configured to send or receive information from one or more mobile medical devices or external systems 205 using communication link 211. In the example, one or more mobile medical devices, external device 206, or remote device 208 can be configured to control one or more parameters of treatment device 210. External system 205 can allow programming of one or more mobile medical devices and can receive information about one or more signals acquired by the one or more mobile medical devices, such as those received via communication link 211. External system 205 may include a local external implantable medical device programmer. External system 205 may include a remote patient management system that can, for example, monitor patient status from a remote location or adjust one or more treatments.

[0099] In some examples, event storage can be triggered, such as by receiving physiological information, or in response to one or more detected events or determined parameters meeting or exceeding a threshold (e.g., a static threshold, a dynamic threshold, or one or more other thresholds based on patient or population information). Information sensed or recorded in high-power mode can be transferred from short-term storage (such as in a cyclic recorder) to long-term or non-volatile memory, or in some examples, prepared for transmission to an external device separate from the medical device. In examples, cardiac electrical or cardiac mechanical information up to and, in some examples, including detected atrial fibrillation events can be stored, such as to increase the specificity of the detection. In examples, multiple cyclic recorder windows (e.g., 2-minute windows) can be stored sequentially. In systems without early detection, recording this information would require a cyclic recorder with a long time period at a significant additional cost (e.g., power, processing resources, component costs, memory requirements, etc.). Storing multiple windows using early detection up to a single event provides a complete event assessment, saving power and cost compared to a longer cyclic recorder window. Furthermore, early detection can trigger additional parameter calculations or storage at different resolutions or sampling frequencies without unduly burdening limited system resources.

[0100] In some examples, one or more alerts may be provided to the patient, clinician, or one or more other caregivers (e.g., using a patient smartwatch, cellular or smartphone, computer, etc.). In some examples, this may be in response to a transition to a high-power mode, in response to a detected event or condition, or after information is updated or transmitted from a first device to a remote device. In other examples, the medical device itself may provide audible or tactile alerts to alert the patient to a detected condition. For example, an alert may be issued to the patient in response to a detected condition so that they may take a corrective action, such as sitting down.

[0101] In some examples, treatment may be provided in response to a detected condition. For example, pacing therapy may be provided, activated, or adjusted, such as to interrupt or reduce the effects of a detected atrial fibrillation event. In other examples, the delivery of one or more medications (e.g., vasoconstrictors, vasopressors, etc.) may be triggered, provided, or adjusted, such as by using a drug pump, in response to a detected condition, alone or in combination with pacing therapy, such as as described above, for example to increase arterial pressure, maintain cardiac output, interrupt or reduce the effects of a detected atrial fibrillation event, or a combination thereof.

[0102] In some examples, a patient's physiological information can be sensed using one or more sensors (such as a cardiac sensor, a heart sound sensor, or one or more other sensors described herein) located within, on, or near the patient. For example, a cardiac sensor can be used to sense the patient's cardiac electrical information. In other examples, a heart sound sensor can be used to sense the patient's cardiac acceleration information. The cardiac sensor and the heart sound sensor can be components of one or more (e.g., the same or different) medical devices (e.g., implantable medical devices, mobile medical devices, etc.). Timing measures between different features (e.g., first cardiac features and second cardiac features, etc.) can be determined, such as through processing circuitry of the cardiac sensor or one or more other medical devices or medical device components. In some examples, timing measures may include the interval or measure between a first cardiac feature and a second cardiac feature in a patient's first cardiac interval (e.g., the duration of a cardiac cycle or interval, QRS width, etc.), or the interval or measure between a first cardiac feature and a second cardiac feature in a patient's corresponding successive first cardiac interval and second cardiac interval. In the example, the first cardiac feature and the second cardiac feature include equivalent detection features in successive first cardiac intervals and second cardiac intervals, such as successive R waves (e.g., RR intervals) or one or more other features of cardiac electrical signals.

[0103] In the examples, the value of a heart sound signal portion or a corresponding heart sound signal of a cardiac interval can be detected as the amplitude relative to one or more cardiac electrical features, or as one or more energy values ​​relative to a window of the heart sound signal, typically determined relative to one or more cardiac electrical features. For example, the value and timing of the S1 signal can be detected using the amplitude or energy of the heart sound signal occurring at or near the R wave of the cardiac interval. The S4 signal portion can be determined, for example, by processing circuitry of a heart sound sensor or one or more other medical devices or medical device components. In some examples, the S4 signal portion may include a filtered signal from the S4 window of the cardiac interval. In the examples, the S4 interval can be defined as a set time period within the cardiac interval relative to one or more other cardiac electrical or mechanical features, such as forward from one or more features of the R wave, T wave, or one or more heart sound waveforms (such as the first heart sound, second heart sound, or third heart sound (S1, S2, S3)), or backward from the detected S1 of a subsequent R wave or subsequent cardiac interval. In some examples, the length of the S4 window may depend on heart rate or one or more other factors. In the example, the timing measure of cardiac electrical information can be the timing measure of the first cardiac interval, and the S4 signal portion can be the S4 signal portion of the same first cardiac interval.

[0104] In the example, heart sound parameters may include information or information about the same heart sound parameter or multiple combinations of heart sound parameters within one or more cardiac cycles or a specified time period (e.g., 1 minute, 1 hour, 1 day, 1 week, etc.). For example, heart sound parameters may include composite S1 parameters representing multiple S1 parameters, for example, within a certain time period (e.g., multiple cardiac cycles, representative time period, etc.).

[0105] In the examples, heart sound parameters may include the overall average of a particular heart sound on a heart sound waveform, such as those disclosed in commonly assigned U.S. Patent No. 7,115,096, entitled "THIRD HEART SOUND ACTIVITY INDEX FOR HEART FAILURE MONITORING" by Siejko et al., or in commonly assigned U.S. Patent No. 7,853,327, entitled "HEART SOUND TRACKING SYSTEM AND METHOD" by Patangay et al., each of which is incorporated herein by reference in its entirety, including their disclosures of overall averaging of acoustic signals and determination of a particular heart sound on a heart sound waveform. In other examples, the signal receiver circuitry may receive at least one heart sound parameter or composite parameter, such as from a heart sound sensor or heart sound sensor circuitry.

[0106] In the example, a patient's cardiac electrical information can be received from a cardiac sensor (e.g., one or more electrodes) or a cardiac sensor circuit (e.g., including one or more amplifier or filter circuits) using a signal receiver circuit, such as a medical device. In the example, the received cardiac electrical information may include a timing measurement between a first cardiac characteristic and a second cardiac characteristic of the patient.

[0107] In the examples, the patient's cardiac acceleration information can be received from a heart sound sensor (e.g., an accelerometer) or a heart sound sensor circuit (e.g., including one or more amplifier or filter circuits) using the same or different signal receiver circuitry of a medical device. In the examples, the received cardiac acceleration information may include an S4 signal portion appearing between the patient's first and second cardiac features. In some examples, additional physiological information, such as heart rate information, patient activity information, or patient posture information, may be received from one or more other sensors or sensor circuits.

[0108] In some examples, a high-power mode may be contrasted with a low-power mode and may include one or more of the following: enabling one or more additional sensors, switching from a low-power sensor or set of sensors to a higher-power sensor or set of sensors, triggering additional sensing from one or more additional sensors or medical devices, increasing the sensing frequency or sensing or storage resolution, increasing the amount of data to be collected, transmitted (e.g., from a first medical device to a second medical device, etc.), or stored, triggering the storage of currently available information from the loop recorder in long-term storage, or increasing the storage capacity or time period of the loop recorder, or otherwise altering the device behavior to capture additional or higher-resolution physiological information or perform more processing, etc.

[0109] Additionally or alternatively, event storage can be triggered. Information sensed or recorded in high-power mode can be transferred from short-term storage (such as in a cyclic recorder) to long-term or non-volatile memory, or in some examples, prepared for transmission to an external device separate from the medical device. In examples, cardiac electrical or mechanical information up to and, in some examples, including detected atrial fibrillation events can be stored, such as to increase the specificity of detection. In examples, multiple cyclic recorder windows (e.g., 2-minute windows) can be stored sequentially. In systems without early detection, recording this information would require a cyclic recorder with a longer time period at significant additional cost (e.g., power, processing resources, component costs, etc.).

[0110] Figure 3 An example method 300 for using chemical information in alerts targeting health indices, as described herein, is shown.

[0111] At step 301, the patient's physiological information can be received, such as using a signal receiver circuit. The patient's physiological information may include at least one of the following: respiratory information (e.g., respiratory rate, tidal volume, RSBI, etc.), cardiac electrical information (e.g., heart rate, impedance, etc.), impedance information, cardiac acceleration information (e.g., heart sounds, etc.), mechanical acceleration information (e.g., activity information, heart sounds, etc.), mechanical position information (e.g., patient posture, sleep tilt, etc.), or other physiological information of the patient.

[0112] At step 302, a health index can be determined, such as as a function of the received physiological information, as discussed elsewhere herein, such as using evaluation circuitry. In an example, this function may include features that can be functions of the physiological information received by the signal receiver circuitry. For example, a feature corresponding to the respiratory rate can be calculated using a high feature value corresponding to a healthy respiratory rate and a low feature value corresponding to an unhealthy respiratory rate. A high respiratory rate (e.g., 30 breaths per minute) can be assigned a value of 100, and a low respiratory rate (e.g., 12 breaths per minute) can be assigned a value of 0. The functional mapping between the high and low respiratory rates can be assigned linearly, logarithmically, etc., or one or more times. The health index can be determined as a function of different features or combinations of physiological information, such as one or more weighted combinations (e.g., average, product, summation, etc.) of two or more features (e.g., each feature having a corresponding weight). This combination can include linear combinations or one or more nonlinear or other combinations.

[0113] At step 303, the patient's chemical information can be received, such as using a signal receiver circuit. The chemical information may include information about chemical substances or other properties within the patient's blood and / or interstitial space, as described elsewhere herein.

[0114] At step 304, the alarm state can be determined using a determined health index and received chemical information (e.g., in alarm state, out of alarm state, priority alarm state, etc.), such as using an evaluation circuit. In the example, the alarm state can use a health index (such as HeartLogic). TMAn index and one or more features of the received chemical information are determined. In the example, the health index may include one or more features based on the received chemical information, and the alarm state determined based on the health index can therefore be an alarm state based on both the health index and the received chemical information. In the example, the health index may not include any features based on the received chemical information, and therefore an alarm state based solely on the health index may not be an alarm state based solely on both the health index and the received chemical information. In this case, the initial alarm based on the health index can be adjusted or enhanced using the received chemical information to derive an alarm based on the chemical information.

[0115] Indications of the determined alarm status can be provided to patients, their doctors, etc. In the example, alarms can be generated and provided to transition or adjust from an out-of-alarm state to an alarm state. Alarms can be provided based on the priority of the determined alarm state with a specified level of urgency (e.g., audible, visual, or tactile alarms, emergency notifications, etc.). If an out-of-alarm state is determined, the alarm state can be rechecked at intervals, such as set intervals (e.g., 1 minute, 5 minutes, 30 minutes, 1 hour, 12 hours, or 1 day). If an alarm state is determined, the system can remain in the alarm state until one or more alarms are reset, or the system determines that it is appropriate to leave the alarm state (e.g., a health index value falls below an out-of-alarm threshold). During an alarm state, device power consumption may increase, possibly due to one or more of the following: the power required to generate and / or transmit one or more alarms, increased monitoring intervals, increased processor load, etc.

[0116] At step 305, the alert based on chemical information may optionally include determining a first alert state and a second alert state. For example, the first alert state can be determined by comparing a health index value determined in step 302 with a health index alert threshold. If the health index is on a specified side of the threshold (e.g., above the threshold, below the threshold), an alert state can be determined. After the first alert state is determined, the system can generate a second alert state based on the determined first alert state and one or more features of the received chemical information. For example, the system can determine the second alert state by adjusting the determined first alert state (e.g., changing from being in an alert state to being out of an alert state, changing from being in an alert state to a priority alert state, maintaining the first alert state, etc.), by enhancing the determined first alert state (e.g., appending one or more additional pieces of information to the alert state), etc. In this example, the system can determine the second alert state based on one or more of the following: the determined first alert state, one or more features of the received chemical information, a health index (e.g., a health index value), one or more other received physiological information, one or more features used in the health index, historical values ​​of one or more features, etc.

[0117] At step 306, determining the alarm based on chemical information may optionally include determining a first chemical parameter and a second chemical parameter. The chemical parameter may include a chemical value determined based on the received chemical information. The first chemical parameter may include chemical information in its raw form (e.g., sensor output, such as an electrical signal, a chemical value in basic units (e.g., concentration, etc.)), or the first chemical parameter may be determined by processing the received chemical information (e.g., converting the sensor output into a chemical value, adjusting the chemical value based on one or more factors (e.g., adjusting to take into account temperature, pressure, other chemical concentrations, etc.)). In this example, the second chemical parameter may be determined, such as in a manner similar to that of the first chemical parameter. The alarm state determined at step 304 may be determined at least in part using one or more of the first chemical parameter, the second chemical parameter, or additional chemical parameters. In this example, the first chemical parameter may represent a potassium level, and the second chemical parameter may represent a creatinine level.

[0118] At step 307, determining the first chemical parameter and the second chemical parameter may optionally include determining a second alarm state based on at least one of the determined first and second chemical parameters. For example, the first chemical parameter may be compared to a first threshold corresponding to one or more of a relatively high value (e.g., a value at which and / or above the chemical parameter is determined to be outside the normal level) or a relatively low value (e.g., a value at which and / or below the chemical parameter is determined to be outside the normal level). The first chemical parameter may also be compared to a second threshold corresponding to one or more of a relatively high or relatively low value. Relative values ​​may include a percentage change from the patient's baseline (e.g., a value above 30% of the patient's baseline may represent a relatively high value, a value below 30% of the patient's baseline may represent a relatively low value, etc.), a deviation from short-term and / or long-term averages greater than a threshold (e.g., a deviation from a long-term average greater than a specified threshold may represent a relatively high value, etc.), a value higher than or lower than one or more patient-specific or population-specific thresholds (e.g., a high threshold may be determined for a specific patient or a specified population), or combinations or arrangements thereof. The results of one or more comparisons can be used to determine an alarm state based on chemical information at step 304, such as determining a second alarm state at step 305.

[0119] At step 308, determining the alarm state may optionally include providing an output of the determined alarm state. For example, the alarm state output may be provided to a patient, a clinician, or another system. The output may be provided to a user interface for display to a user, or to control circuitry to control or adjust the processes or functions of the medical device system. For example, the output may automatically adjust the medical device system that is providing one or more treatments to a patient (e.g., medication administration, such as those described herein, cardiac rhythm management, etc.).

[0120] In some examples, the techniques of any one or more of steps 305 to 308 can be used in various combinations or arrangements. In some examples, any one or more of steps 305 to 308 can be applied to more than one chemical information.

[0121] Figure 4 An example method 400 for determining a second alarm state using chemical information is shown, as described herein.

[0122] At step 401, a first alarm state can be determined, as described above with respect to step 305. For example, the first alarm state can be determined by comparing the health index value determined in step 302 with a health index alarm threshold. If the health index is on a specified side of the threshold (e.g., above the threshold, below the threshold), then an alarm state can be determined.

[0123] At step 402, one or more chemical parameters (such as those determined in step 306) may be compared to one or more thresholds to determine whether the chemical parameter is within a normal range. For example, the chemical parameter may be compared to one or more of a first threshold, which corresponds to a relatively high value (e.g., a value at which and / or above which the chemical parameter is determined to be outside the normal level) or a relatively low value (e.g., a value at which and / or below which the chemical parameter is determined to be outside the normal level). The first chemical parameter may also be compared to a second threshold corresponding to one or more of a relatively high or relatively low value. In this example, the first threshold may represent a relatively low value, and the second threshold may represent a relatively high value. If the chemical parameter is above the first threshold and below the second threshold, the chemical parameter may be determined to be within the normal range.

[0124] At step 403, if one or more chemical parameters are determined to be normal, a first output can be provided. For example, the first output could include an output indicating a first alarm state before the chemical information is considered. In this example, the first output could include an indication that the chemical information has been considered and is within the normal range. The first output could be provided to a user interface for display to a user, or to control circuitry to control or adjust the processes or functions of the medical device system.

[0125] At step 404, if the chemical information is abnormal, a second alarm state can be determined, as described above regarding step 305. The second alarm state may include one of several guideline-guided drug therapy (GDMT) alarm states associated with treatment adjustments. For example, a second alarm state may include instructing the system or clinician to administer or provide a class of drugs to a patient.

[0126] At step 405, when the determined first chemical parameter indicates that the potassium level is below a relatively low potassium value (e.g., below the potassium threshold) and / or the determined second chemical parameter indicates that the creatinine value is below a relatively low creatinine value (e.g., below the creatinine threshold), the second alarm state can provide a control signal to provide or increase a potassium-sparing diuretic.

[0127] At step 406, when the determined first chemical parameter indicates that the potassium level is above a relatively high potassium value (e.g., above the potassium threshold) and / or the determined second chemical parameter indicates that the creatinine value is below a relatively low creatinine value (e.g., below the creatinine threshold), the second alarm state can provide a control signal to provide or increase a thiazide diuretic.

[0128] At step 407, when the determined second chemical parameter indicates that the creatinine value is higher than a relatively high creatinine value (e.g., higher than the creatinine threshold), the second alarm state can provide a control signal to provide or increase a vasodilator.

[0129] At step 408, a second output corresponding to the second alarm state may be provided. The second output may be provided as an alternative to or supplement to the first output. The second output may be provided to a user interface for display to the user, or to control circuitry for controlling or adjusting the processes or functions of the medical device system.

[0130] Figure 5 An implantable medical device (IMD) 500 electrically coupled to a heart 505 is illustrated, such as via one or more leads coupled to the IMD 500 (via one or more lead ports in the head 502 of the IMD 500, including a first lead port, a second lead port, or a third lead port 541, 542, 543)). In the example, the IMD 500 may include an antenna, such as in the head 502, configured to enable communication with external systems and one or more electronic circuits (e.g., evaluation circuitry, etc.) in a hermetically sealed housing (CAN) 501. The IMD 500 illustrates an example medical device (or medical device system) as described herein.

[0131] The IMD 500 may include an implantable medical device (IMD), such as an implantable cardiac monitor (ICM), pacemaker, defibrillator, cardiac resynchronizer, or other subcutaneous IMD or cardiac rhythm management (CRM) device, configured to be implanted in the chest of a subject, having one or more leads to position one or more electrodes or other sensors in or near the heart 505, such as one or more in the atria or ventricles. Separate from or in addition to the leads, the IMD 500 may also include one or more electrodes or other sensors (e.g., pressure sensors, accelerometers, gyroscopes, microphones, etc.) powered by a power source within the IMD 500. The leads, one or more electrodes or other sensors of the IMD 500, or combinations thereof, may be configured to detect physiological information from the patient or to provide one or more treatments or stimuli to the patient.

[0132] IMD 500 may include one or more electronic circuits configured to sense one or more physiological signals, such as electrograms or signals representing the mechanical function of the heart 505. In some examples, CAN 501 may function as an electrode, such as for sensing or pulse delivery. For example, electrodes from one or more leads may be used with CAN 501, such as for unipolar sensing for electrograms or for delivering one or more pacing pulses. Defibrillation electrodes (e.g., first defibrillation coil electrode 528, second defibrillation coil electrode 529, etc.) may be used with CAN 501 to deliver one or more cardioversion / defibrillation pulses.

[0133] In the example, the IMD 500 can sense impedance between electrodes, such as those located on one or more leads or on the CAN 501. The IMD 500 can be configured to inject current between a pair of electrodes, sense the resulting voltage between the same or different pairs of electrodes, and determine the impedance, such as using Ohm's law. Impedance can be sensed in a bipolar configuration (where the same pair of electrodes can be used for both current injection and voltage sensing), a tripolar configuration (where the pair of electrodes used for current injection and the pair used for voltage sensing can share a common electrode), or a quadrupole configuration (where the electrodes used for current injection can be different from those used for voltage sensing), etc. In the example, the IMD 500 can be configured to inject current between electrodes on one or more of the first, second, third, or fourth leads 520, 525, 530, 535 and the CAN 501, and sense the resulting voltage between the same or different electrodes and the CAN 501.

[0134] Figure 5 Example lead configurations include first, second, and third leads 520, 525, and 530, respectively, placed in the coronary veins 516 (e.g., coronary sinuses) on the right atrium (RA) 506, right ventricle (RV) 507, and left atrium (LA) 508 and left ventricle (LV) 509, using conventional lead placement; and a fourth lead 535 positioned in RV 507, near His bundle 511, between AV node 510 and the right and left bundle branches 512, 513 and Purkinje fibers 514, 515. Each lead can be configured to position one or more electrodes or other sensors at various locations in or near the heart 505 to detect physiological information or provide one or more treatments or stimulations.

[0135] The first lead 520, located in RA 506, includes a first tip electrode 521 located at or near the distal end of the first lead 520 and a first ring electrode 522 located near the first tip electrode 521. The second lead 525 (dashed line), located in RV 507, includes a second tip electrode 526 located at or near the distal end of the second lead 525 and a second ring electrode 527 located near the second tip electrode 526. The third lead 530, located in the coronary vein 516 above LV 509, includes a third tip electrode 531 located at or near the distal end of the third lead 530, a third ring electrode 532 located near the third tip electrode 531, and two additional electrodes 533 and 534. The fourth lead 535, located near the His bundle 511 in RV 507, includes a fourth tip electrode 536 located at or near the distal end of the fourth lead 535 and a fourth ring electrode 537 located near the fourth tip electrode 536. Tip electrodes and loop electrodes may include pacing / sensing electrodes configured to sense electrical activity or provide pacing stimulation.

[0136] In addition to the tip and loop electrodes, one or more leads may also include one or more defibrillation coil electrodes configured to sense electrical activity or provide cardioversion or defibrillation shock energy. For example, the second lead 525 includes a first defibrillation coil electrode 528 located near the distal end of the second lead 525 in RV 507 and a second defibrillation coil electrode 529 located at a distance from the distal end of the second lead 525, such as for placement in or near the superior vena cava (SVC) 517.

[0137] Different CRM devices include varying numbers of leads and lead placements. For example, some CRM devices are single-lead devices with only one lead (e.g., RV only, RA only, etc.). Other CRM devices are multi-lead devices with two or more leads (e.g., RA and RV; RV and LV; RA, RV, and LV, etc.). CRM devices suitable for His bundle pacing often use lead ports designated for the LV or RV lead to deliver stimulation to the His bundle 511.

[0138] Figure 6 A block diagram of example machine 600 is shown, on which any one or more of the techniques (e.g., methods) discussed herein can be executed. Parts of this description can be applied to the computational framework of one or more of the medical devices described herein, such as implantable medical devices, external programmers, etc. Furthermore, as described herein with respect to medical device components, systems, or machines, this may require regulatory compliance that cannot be met by general-purpose computers, components, or machines.

[0139] Examples, as described herein, may include logic or multiple components or mechanisms in machine 600, or those that can be operated by them. A circuit system (e.g., a processing circuit system, an evaluation circuit, etc.) is a collection of circuits implemented in a tangible entity of machine 600, which includes hardware (e.g., simple circuits, gates, logic, etc.). Circuit system members can be flexible over time. A circuit system includes members that can perform a specified operation individually or in combination during operation. In the example, the hardware of the circuit system may be designed immutably to perform a specific operation (e.g., hardwired). In the example, the hardware of the circuit system may include physically connected components (e.g., execution units, transistors, simple circuits, etc.) including machine-readable media that are physically modified (e.g., magnetic ground, electrical ground, movable placement of immutable aggregate particles, etc.) to encode instructions for a specific operation. When the physical components are connected, the underlying electrical characteristics of the hardware composition change, for example, from an insulator to a conductor, or vice versa. Instructions enable embedded hardware (e.g., an execution unit or loading mechanism) to create members of the circuit system in the hardware via variable connections to perform portions of a specific operation during operation. Therefore, in this example, the machine-readable medium element is part of the circuit system, or is communicatively coupled to other components of the circuit system during device operation. In this example, any of the physical components can be used in more than one member of more than one circuit system. For example, under operation, an execution unit can be used at one point in time in a first circuit of a first circuit system, and reused at different times by a second circuit of the first circuit system or by a third circuit of the second circuit system. Additional examples of these components of machine 600 are as follows.

[0140] In alternative embodiments, machine 600 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, machine 600 may operate as a server machine, a client machine, or both in a server-client network environment. In the example, machine 600 may act as a peer-to-peer (P2P) (or other distributed) network environment. Machine 600 may be a personal computer (PC), tablet PC, set-top box (STB), personal digital assistant (PDA), mobile phone, web appliance, network router, switch, or bridge, or any machine capable of executing instructions (sequentially or otherwise) specifying actions to be taken by that machine. Furthermore, although only a single machine is shown, the term "machine" should also be considered to include any collection of machines, such as cloud computing, software as a service (SaaS), and other computer cluster configurations, that individually or jointly execute a set (or more) of instructions to perform any one or more of the methods discussed herein.

[0141] Machine 600 (e.g., a computer system) may include a hardware processor 602 (e.g., a central processing unit (CPU), graphics processing unit (GPU), hardware processor core, or any combination thereof), main memory 604, static memory 606 (e.g., memory or storage device for firmware, microcode, basic-input-output (BIOS), unified extensible firmware interface (UEFI), etc.), and mass storage device 608 (e.g., hard disk drive, tape drive, flash memory, or other block device), some or all of which may communicate with each other via interconnect 630 (e.g., a bus). Machine 600 may also include a display unit 610, an input device 612 (e.g., a keyboard), and a user interface (UI) navigation device 614 (e.g., a mouse). In this example, the display unit 610, input device 612, and UI navigation device 614 may be a touchscreen display. Machine 600 may additionally include a signal generating device 618 (e.g., a speaker), a network interface device 620, and one or more sensors 616, such as a global positioning system (GPS) sensor, a compass, an accelerometer, or one or more other sensors. Machine 600 may include an output controller 628, such as a serial (e.g., universal serial bus, USB), parallel, or other wired or wireless (e.g., infrared, near field communication, NFC) connection, to communicate with or control one or more peripheral devices (e.g., a printer, a card reader, etc.).

[0142] The registers, main memory, static memory, or mass storage device 608 of the hardware processor 602 may be or include a machine-readable medium 622 on which one or more sets of data structures or instructions 624 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein are stored. During execution of the instructions 624 by the machine 600, the instructions 624 may also reside wholly or at least partially within any one of the registers, main memory, static memory, or mass storage device 608 of the hardware processor 602. In the example, one or any combination of the hardware processor 602, main memory 604, static memory 606, or mass storage device 608 may constitute the machine-readable medium 622. Although the machine-readable medium 622 is shown as a single medium, the term "machine-readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database and / or associated caches and servers) configured to store one or more instructions 624.

[0143] The term "machine-readable medium" can include any medium capable of storing, encoding, or carrying instructions that are executed by machine 600 and cause machine 600 to perform any one or more of the techniques of this disclosure, or any medium capable of storing, encoding, or carrying data structures used by or associated with those instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In examples, non-transient machine-readable media includes machine-readable media with a plurality of particles having invariant (e.g., rest) mass, and is therefore a composition of matter. Thus, a non-transient machine-readable medium is a machine-readable medium that does not include transiently propagating signals. Specific examples of non-transient machine-readable media may include: non-volatile memories, such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM) and electrically erasable programmable read-only memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable hard disks; magneto-optical disks; and CD-ROMs and DVD-ROMs.

[0144] Instruction 624 can be further transmitted or received on communication network 626 via network interface device 620 using a transmission medium, utilizing any of a variety of transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Example communication networks may include, among others, local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), mobile phone networks (e.g., cellular networks), plain old telephone (POTS) networks, and wireless data networks (e.g., the Institute of Electrical and Electronics Engineers (IEEE) 802.11 standard family known as Wi-Fi®, the IEEE 802.16 standard family known as WiMax®), the IEEE 802.15.4 standard family, and peer-to-peer (P2P) networks. In the example, network interface device 620 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connection to communication network 626. In the example, network interface device 620 may include multiple antennas for wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technologies. The term "transmission medium" should be considered to include any intangible medium capable of storing, encoding, or carrying instructions executable by machine 600, and includes digital or analog communication signals or other intangible media to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0145] Various embodiments are illustrated in the figures above. One or more features from one or more of these embodiments may be combined to form other embodiments. The method examples described herein may be implemented, at least in part, by a machine or computer. Some examples may include a computer-readable or machine-readable medium encoded with instructions operable to configure an electronic device or system to perform the methods described in the examples above. Implementations of such methods may include code, such as microcode, assembly language code, or high-level language code or similar code. Such code may include computer-readable instructions for performing various methods. The code may form part of a computer program product. Furthermore, the code may be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.

[0146] The detailed description above is intended to be illustrative and not restrictive. Therefore, the scope of this disclosure should be determined by reference to the appended claims together with the full scope of the equivalents to which such claims are entitled.

Claims

1. A medical device system, comprising: A signal receiver circuit configured to receive physiological information from the patient; as well as An evaluation circuit is configured to determine the patient's health index as a function of the received physiological information. The signal receiver circuit is configured to receive the patient's chemical information, and The assessment circuit is configured to use the determined health index and received chemical information to determine the patient's alarm state.

2. The medical device system according to claim 1, wherein, The health index includes a comprehensive health index, wherein the assessment circuit is configured to determine the comprehensive health index for the patient as a function of at least two features of the received physiological information.

3. The medical device system according to any one of claims 1 to 2, wherein, To determine the patient's alarm status, the assessment circuit is configured to: The patient's first alarm state is determined using the determined health index value and health index alarm threshold; and The second alarm state is determined based on the established first alarm state and the received chemical information of the patient.

4. The medical device system according to claim 3, wherein, The second alert status is one of several guidelines-guided medical treatment (GDMT) alert statuses associated with treatment adjustments. The evaluation circuit is configured to provide the output of the determined alarm status to the user interface for display to the user, or to provide it to the control circuit to control or adjust the process or function of the medical device system.

5. The medical device system according to claim 4, wherein, The evaluation circuit is configured to use the received chemical information to determine a first chemical parameter and a second chemical parameter. The received chemical information includes at least one of the patient's potassium or creatinine information. Wherein, the first chemical parameter and the second chemical parameter include an indication of a relatively high or low value of the received chemical information relative to one or more thresholds. Specifically, to determine the first alarm state, the evaluation circuit is configured to determine that the value of the determined health index is higher than the health index alarm threshold, and The evaluation circuit is configured to determine the second alarm state based on at least one of a determined first alarm state and a determined first chemical parameter and a second chemical parameter.

6. The medical device system according to claim 5, wherein, Determining the second alarm state includes determining that the patient's potassium information is below a potassium threshold, and that the patient's creatinine information is below a creatinine threshold, and The evaluation circuit is configured to provide a control signal to provide or increase a potassium-sparing diuretic in response to determining the second alarm state.

7. The medical device system according to claim 5, wherein, Determining the second alarm state includes determining that the patient's potassium information is above a potassium threshold and that the patient's creatinine information is below a creatinine threshold. The evaluation circuit is configured to provide a control signal to provide or increase a thiazide diuretic in response to determining the second alarm state.

8. The medical device system according to claim 5, wherein, Determining the second alarm state includes determining that the patient's creatinine information is higher than a creatinine threshold, and The evaluation circuit is configured to provide a control signal to provide or increase a vasodilator in response to determining the second alarm state.

9. The medical device system according to any one of claims 3 to 8, wherein, The health index includes a heart failure index, and the health index alarm threshold includes a heart failure alarm threshold.

10. A method comprising: The patient's physiological information is received using a signal receiver circuit. The evaluation circuitry is used to determine the patient's health index as a function of the received physiological information. The signal receiver circuit is used to receive the patient's chemical information, and Using the assessment circuit, the determined health index and received chemical information are used to determine the patient's alarm state.

11. The method according to claim 10, wherein, Determining the patient's alarm status includes: The patient's first alarm state is determined using the determined health index value and health index alarm threshold, and The second alarm state is determined based on the established first alarm state and the received chemical information of the patient.

12. The method of claim 11, comprising: The evaluation circuitry can be used to provide the output of the determined alarm status to the user interface for display, or to provide it to the control circuitry to control or adjust the processes or functions of the medical device system. The second alert status is one of several guidelines-guided medical treatment (GDMT) alert statuses associated with treatment adjustments.

13. The method of claim 12, further comprising using the evaluation circuit to determine a first chemical parameter and a second chemical parameter using the received chemical information. in, The received chemical information includes at least one of the patient's potassium or creatinine information. Wherein, the first chemical parameter and the second chemical parameter include an indication of a relatively high or low value of the received chemical information relative to one or more thresholds. Determining the first alarm state includes determining that the value of the determined health index is higher than the health index alarm threshold, and Determining the second alarm state includes determining the second alarm state based on at least one of the determined first alarm state and the determined first chemical parameter and second chemical parameter.

14. The method according to claim 13, wherein, Determining the second alarm state includes determining that the patient's potassium information is below a potassium threshold, and that the patient's creatinine information is below a creatinine threshold, and In response to determining the second alarm state, a control signal is provided to provide or increase potassium-sparing diuretics.

15. The method according to claim 13, wherein, Determining the second alarm state includes determining that the patient's potassium information is above a potassium threshold and that the patient's creatinine information is below a creatinine threshold. In response to determining the second alarm state, a control signal is provided to provide or increase the dosage of a thiazide diuretic.

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