A personalised system for monitoring life-threatening conditions in patients with chronic kidney disease

TECHNICAL FIELD

The invention relates to the field of medical equipment, and more particularly to a system and method for monitoring life-threatening conditions in patients with chronic kidney disease.

BACKGROUND OF THE INVENTION

In clinical practice, serum electrolytes are assessed by invasive blood testing, but in recent years there has been an active effort to develop technologies capable of recognizing electrolyte imbalance in a non-invasive manner by analyzing the body surface electrocardiogram signal. Researchers at the Mayo Clinic are developing an algorithm for estimating serum potassium levels based on surface electrocardiogram analysis by recording signals with electrodes glued to the chest (Attia Z. et al. Novel bloodless potassium determination using a signal-processed single lead ECG, Journal of the American Heart Association, 5 (1), e002746, 2016), or with electrodes integrated into a smartphone case (Yasin OZ et al. Noninvasive blood potassium measurement using signal-processed , single-lead ECG acquired from a handheld smartphone, Journal of Electrocardiology, 50, 620-625, 2017). Document US 8948854 B2 (published 03/03/2015) describes a method and system developed by researchers at the Mayo Clinic for non-invasive recognition of changes in blood composition. Fluctuations and physiological disorders of electrolytes (e.g., potassium, calcium, magnesium, etc.) are assessed by analyzing patterns of electrocardiogram signals averaged over cardiac cycles that allow the pathological blood composition to be distinguished from normal. The document does not detail the methodology of electrocardiogram recording, and it is not possible to associate changes in blood composition with arrhythmia episodes or their risk.

US 9848778 B2 (published 26/12/2017) describes a method, apparatus and system for monitoring the condition of patients with kidney disease. Changes in blood potassium levels are determined by recognizing changes in muscle or nerve cell activity from an electromyogram and / or electrocardiogram signal; analyzing the R and T waveforms of the electrocardiogram signal; an electromyographic sensor for recording the response of tissues to the generated sequences of electrical impulses. The device described in the patent assesses a patient's risk of hyperkalemia, hypokalemia, and arrhythmias and may be superficial or implantable. The method described uses only an electrocardiogram signal recorded on the patient's chest or invasively and evaluates changes in blood levels of only one electrolyte (potassium). US 9289165 B2 (published 22/02/2016) describes a method and apparatus for monitoring changes in the concentration of various ions (e.g., potassium, sodium, chlorine, calcium, magnesium) in a patient's extracellular fluid. Ion concentration is monitored by electrically stimulating the patient’s tissues (e.g., heart muscle, skeletal muscle, smooth muscle, nerve tissue, skin) and recording their response to stimulation. The method described in the patent does not analyze electrocardiogram signal waveforms to determine changes in serum electrolytes.

US 9554725 B2 (published 31/01/2017) describes methods and a device for measuring bioelectrical impedance for non-invasive monitoring of the condition of patients with renal dysfunction during hemodialysis. By analyzing bioelectrical impedance signals, the system can determine how much fluid needs to be removed during hemodialysis, the rate of fluid removal, as well as the patient’s level of hydration and electrolyte balance. The described system does not provide monitoring of electrolyte fluctuations under everyday living conditions.

Standard non-invasive Holter monitors and heart event recorders using adhesive electrodes or invasive devices such as implantable cardioverter-defibrillators are used to detect life-threatening arrhythmias. Advances in electronics and medical technology in recent years have opened up the possibility of recognizing arrhythmias using more patient-friendly, minimally contacting techniques, such as photoplethysmography, signal recording by a smartphone camera, webcam, in-ear sensor, or smart bracelet. devices using the principle of photoplethysmography to detect arrhythmias are so far limited to atrial fibrillation arrhythmias (US 6519490 B1, US 7846106 B2, US 9433386 B2) or ventricular extrasystoles (US 7794406 B2, Soloshenko A. et.al.) Photoplethysmographybased method premature ventricular contractions, 9 (5), 662-669, 2015). In themselves, these heart rhythm disorders are not classified as life-threatening arrhythmias. The reliability of the arrhythmia recognition photoplethysmogram signal recorded by the bracelet with integrated sensors in everyday life is highly dependent on the signal quality, which is often insufficient due to motion artifacts, so the arrhythmia recognition method can be used to increase the reliability. 9839363 B2, US 2017/0202459 A1, US 2015/0366518 A1). In bracelets using this method, integrated photoplethysmographic sensors continuously register a heart rate, which, when atrial fibrillation is detected, triggers an alarm to inform the system user of an external device (US 9420956 B2) or a bracelet-integrated biopotential sensor The function of the external electrocardiogram recorder can be performed by various devices, such as a smartphone case with integrated bioelectrical potential electrodes, an outpatient or clinical electrocardiogram recorder, and so on.

US 2015/0366518 A1 (published 24/12/2015) provides methods and a system for detecting and alerting individuals to significant and health-threatening situations (eg imminent myocardial infarction, stroke, epileptic seizure, etc.) and, if necessary , activate panic mode and call an ambulance remotely. The system records photoplethysmogram, accelerometer and, if necessary, short-term electrocardiogram signals. Various modifications to the device are indicated, including both bracelets and spectacles with integrated photoplethysmogram sensors. The patent application does not describe methods for recognizing life-threatening arrhythmias. The closest analogue, US 2017/0172424 A1 (published on 22/06/2017), describes a device for detecting a life-threatening deterioration in cardiac function leading to cardiac arrest. The device registers a photoplethysmogram signal that recognizes a life-threatening decrease in heart rate and can automatically contact an ambulance, but is not adapted to recognize episodes of other life-threatening arrhythmias.

The analyzed prior art solutions have the following drawbacks compared to the solution presented in this description:

The analyzed wear systems cannot non-invasively assess electrolyte fluctuations, relate them to food intake and time of day, recognize pathological changes in electrolyte balance.

The analyzed systems do not evaluate the relationship between electrolyte fluctuations and the occurrence of life-threatening arrhythmia episodes in the general context.

The analyzed wear systems do not have the ability to recognize life-threatening cardiac arrhythmias (ventricular bradycardia, ventricular tachycardia, ventricular flutter, ventricular fibrillation) in real time.

The systems analyzed do not assess the risk of sudden death.

The analyzed wear systems do not have the ability to send an alarm message to the doctor after real-time detection of life-threatening cardiac arrhythmias.

The technical solution presented in this description does not have the shortcomings listed above.

SUMMARY OF THE INVENTION

This description provides a system and method for identifying and monitoring life-threatening health conditions, including electrolyte imbalances and life-threatening arrhythmias. In contrast to the present solutions, the described invention is non-invasive and does not interfere with the patient, therefore life-threatening arrhythmias and electrolyte fluctuations can be monitored continuously - in the clinic and at home. Non-invasive life-threatening health monitoring technology is useful for monitoring patients in the clinic (e.g., to alert hemodialysis clinic staff about the risk of arrhythmias) as well as at home, as it allows treatment to be initiated (e.g., to advance hemodialysis) before serious cardiac arrhythmias occur. The system is intended for hemodialysis facilities that provide a life-threatening condition monitoring service to their patients; as well as in patients after severe illness (myocardial infarction, after cancer treatment with chemotherapy); peritoneal dialysis patients who perform dialysis independently at home without the constant supervision of medical staff.

The system consists of a wearable device used by the patient with integrated modules for real-time recognition and monitoring of life-threatening conditions; a smart device used by the patient (e.g., smartphone, tablet, etc.) to monitor electrolyte fluctuations and enter additional information; a smart device used by a physician (e.g., smartphone, tablet, smartwatch, etc.) or personal computer to analyze aggregated results; server software modules for assessing the risk of sudden death based on the synergy of biosignals. Life-threatening conditions are identified by photoplethysmograms, electrocardiograms, bioimpedance spectroscopy, and motion signals. When worn on the hand, the device continuously records a photoplethysmogram that is used to recognize life-threatening arrhythmias. A short-term (~ 1 min.) Electrocardiogram signal recorded on a wrist-worn device is used to indirectly monitor electrolyte fluctuations. To obtain a higher number of electrocardiogram derivations (eg I, II, III, aVR, aVL, aVF) and to increase the reliability of the solutions, the algorithms can be used in other devices with the possibility to record an electrocardiogram, such as smart scales with integrated electrodes in the handle. Data transfer from the patient’s home is accomplished using cloud technology through the patient’s smart device. During long-term monitoring, the doctor is notified by e-mail when life-threatening conditions are automatically identified.

BRIEF DESCRIPTION OF THE DRAWINGS

Options for implementing the system are described in detail below with reference to the accompanying drawings, in which:

fig. A diagram of the main components of the system and their interaction is shown.

fig. An illustration of the main components that make up a patient wear device is shown.

fig. Typical examples of electrocardiogram and photoplethysmogram signals during life-threatening arrhythmias and possible values ​​of signal temporal parameters to identify different types of life-threatening arrhythmias are presented.

fig. One of the possible methods of electrocardiogram signal processing, which allows to obtain parameters for estimating electrolyte fluctuations, is presented for installation in a device worn by a patient.

fig. The concept of a graphical user interface for a patient smart device (e.g., smartphone, tablet, etc.).

fig. The concept of a graphical user interface for a physician’s smart device (e.g., smartphone, tablet, etc.) or personal computer.

The illustrations provided are more illustrative, scale, proportions and other aspects do not necessarily correspond to a real technical solution.

BEST MODES FOR IMPLEMENTATION

Describes a system and method for the non-intrusive identification and monitoring of life-threatening health conditions in patients with chronic kidney disease undergoing hemodialysis. In the final stage of chronic kidney disease, one-third of deaths are sudden deaths due to life-threatening cardiac arrhythmias, much of which occurs on the last day of the long interval between hemodialysis sessions, which is associated with electrolyte imbalance in the blood. Electrolyte imbalance is particularly common in hemodialysis patients and requires monitoring of its change between hemodialysis sessions to restore normal balance before arrhythmias occur.

The system consists of a wearable device with integrated biosignal (photoplethysmogram, electrocardiogram, bioimpedance, motion) sensors; modules for detecting and monitoring electrolytes (potassium, calcium, magnesium, etc.) imbalance in a short-term electrocardiogram signal for integration into a wearable Device; modules for the detection and monitoring of life-threatening cardiac arrhythmias (bradycardia, ventricular tachycardia, ventricular fibrillation, ventricular fibrillation) combining continuous photoplethysmogram and transient electrocardiogram signals for integration into a wearable device; sudden death risk assessment module for use on a server, personal computer, or smart device (e.g., smartphone, tablet, smart watch, etc.). The provided system and method allow long-term monitoring of life-threatening conditions in a non-disruptive manner, so it can be used both in hemodialysis institutions and in the patient's home, especially during the long (3 days) period between hemodialysis sessions.

This description provides, but is not limited to, a system (Figure 1) and method for the treatment of patients with chronic kidney disease who are at increased risk for life-threatening conditions (electrolyte fluctuations and cardiac arrhythmias). The concept of developing personalized decision support systems and techniques can be adapted to other groups of clinical pathologies that experience episodes of electrolyte fluctuations and life-threatening arrhythmias, such as heart failure, myocardial infarction, or chemotherapy procedures.

System description

The system for recognizing and monitoring life-threatening conditions in a way that does not interfere with the patient shall comprise at least the following devices:

Equipment used by the patient:

1. Patient wear device (1);

2. Patient smart device (2);

Equipment used by the doctor:

3. Physician 's smart device or personal computer (3).

In addition to the devices listed above, the system also comprises a server with an integrated emergency risk assessment module (4), which combines data aggregation and analysis units (5), expert system unit (6), alarm (7) and risk assessment (8) units. , patient data (9) and physician recommendations (10). The server has technical measures in place to ensure the security of user data. The system also includes an Internet network infrastructure, technical means to ensure the interconnection of the listed devices and the possibility of data exchange.

Patient wear device (1) means a device capable of recognizing life-threatening cardiac arrhythmias from a continuously recorded photoplethysmogram signal in real time and capable of performing other functions specific to such devices, such as instantaneous pulse recording, physical activity assessment with integrated motion sensor, etc. The device worn by the patient is usually attached to the arm, but can also be attached to other parts of the body (e.g., forearm, leg, head, ear, etc.). The function of such a device may be performed by a smart bracelet, a smart watch, a smart headset, a smart headband, and other smart devices that can be used in said manner and have said functions. The lower part of the patient wear device (1) (Fig. 2) (11) has an integrated photoplethysmography sensor (12) for recording a continuous photoplethysmogram signal. The inner electrodes (13) are also integrated in the lower part (Fig. 2) (11) of the patient wear device (1), and the outer electrodes (15) in the upper part (14) of the patient wear device (1) are insulated from the inner electrodes (13). ). The inner electrodes (13) are in constant contact with the skin of the wrist on which they are placed, so that when the outer electrodes (15) are touched with the finger of the other hand, an electrocardiogram signal is recorded. An external device capable of exchanging signals and / or data with the patient's smart device (2) or server (4), such as smart scales with electrodes integrated in the handle, can also be used to record the short-term electrocardiogram signal. The wearer (1) may also have integrated sensors for recording bioimpedance and impedance program signals, which are used to assess the patient's health. To ensure the quality of the recorded signals, capacitive sensors can be integrated in the patient wear device (1), which use the recorded signals in adaptive algorithms to remove artifacts from the photoplethysmogram signal and to detect poor sensor contact with the patient's skin. The wear device (1) transmits signals and data to the server (4) during charging of the device via a USB port of a computer or similar device and / or wirelessly via a patient smart device (2).

The patient smart device (2) is designed to provide data exchange between the patient wear device and the system server. The patient's smart device (2) allows the patient to monitor his or her medical condition and enter information relevant to the physician, as well as to receive physician instructions and reminders that are important for maintaining the patient's health. The patient smart device (2) can also process the signals recorded by the patient wearing the device (1) and recognize health hazards. The functions of the patient smart device (2) can be performed by various smart devices (eg smartphone, tablet, smart watch, etc.) with technical means for connection to the Internet, with installed system software ensuring data exchange with the system server (4).

The physician's smart device (3) is designed to provide the physician with access to the patient's health data on the system server (4). The doctor's smart device (3) enables the doctor to obtain detailed information about the patient's behavior and state of health, on the basis of which he makes a decision on his smart device. The functions of the doctor's smart device (3) can be performed by various smart devices (eg smartphone, tablet, smartwatch, etc.) with technical means for connecting to the Internet and having data exchange with the system server ( 4).

Description of the method

Life-threatening conditions due to electrolyte fluctuations and arrhythmias are assessed in the system as described below. Signals of different natures are used to monitor electrolyte fluctuations and arrhythmias, but the patient's health status is assessed by linking the results of the analysis of these signals. The interrelationships between electrolyte fluctuations and arrhythmias are identified, which are used to increase the sensitivity and specificity of the system in detecting life-threatening conditions in the patient.

The patient-worn device (1) or a separate smart device (2) controlling it is equipped with software modules for the recognition of life-threatening cardiac arrhythmias in photoplethysmogram signals (Fig. 4), which:

Analyzes the photoplethysmogram signal in real time and recognizes life-threatening cardiac arrhythmias.

Upon automatic detection of life-threatening arrhythmias, inform the system user to touch the electrodes integrated in the wearer and thereby record a transient electrocardiogram signal to confirm the arrhythmia.

When life-threatening cardiac arrhythmias are detected, it sends data to a server for further analysis and reporting.

If a life-threatening arrhythmia persists, send an alarm to the physician's smart device.

The algorithm for the recognition of life-threatening cardiac arrhythmias and the monitoring of long-term arrhythmia progression is based on the analysis of temporal and amplitude changes in photoplethysmogram signal parameters (Fig. 3). Life-threatening arrhythmias are identified by the distinctive features of the individual type of arrhythmia, eg bradycardia (16) is recognized by a significant reduction in rhythm to 60 beats per minute, ventricular tachycardia (17) by a regular rhythm of 110-250 beats per minute with a sudden onset and end and a constant decrease in pulse amplitude, ventricular flutter (18) - irregular rhythm of 250-350 beats per minute and decreased pulse amplitude of varying magnitude, ventricular fibrillation (19) - irregular rhythm of more than 400 beats per minute and vanishingly low pulse amplitude. The number of false alarms due to motion artifacts and other, less significant, arrhythmias can be reduced by taking into account the information provided by other recorded signals, such as electrolyte fluctuations. If electrolyte imbalance is detected, the threshold for detecting arrhythmias may be lowered and increased at normal electrolyte balance. In addition, an impedance program signal can be recorded and analyzed using a patient wear device (1) to detect life-threatening arrhythmias.

The patient-worn device (1) or a separate smart device (2) controlling it is equipped with software modules for the assessment of electrolyte fluctuations in the electrocardiogram signals (Fig. 3), which:

Automatically informs the system user at specified intervals to record a transient electrocardiogram signal to assess electrolyte fluctuations.

After evaluating electrolyte fluctuations, it sends data to a server to collect, visualize, analyze, report, and inform physicians.

In the event of a health-threatening electrolyte imbalance, send an alarm to the physician's smart device.

Electrolytes (potassium, calcium, magnesium, etc.) fluctuations are assessed from the short-term electrocardiogram signal by distinguishing signs of its waveforms, amplitudes, and durations (Fig. 4). These signs can be assessed from an electrocardiogram of one cardiac cycle, or by averaging electrocardiograms of several cardiac cycles. Signs can be distinguished from the electrocardiogram signal directly (20) (amplitude, duration, slope, etc. of individual waves). By increasing noise resistance, features can also be distinguished indirectly from models (21) that coincide with electrocardiogram signal waves (normal (22), lognormal (23), or other function parameters). In addition to the patient's smart device (1), a short-term electrocardiogram signal recorded by another device, such as a smart balance, can be used to determine electrolyte fluctuations. The reliability of the determination of electrolyte fluctuations can be increased by calibrating the method based on the results of pre- and post-dialysis blood tests.

The server software module (4) analyzes the distribution and progress profile of life-threatening conditions recorded in the long-term wearable device (1) and presents episodes of electrolyte fluctuations and arrhythmias and their relationship parameters, predicts system user, patient, dangerous conditions and evaluates sudden death. risk. The server software module (4) also provides the ability to exchange data between devices, visualize data, and generate reports. The patient's smart device (2) and the doctor's smart device or personal computer (3) connect to the server via an Internet connection (https and / or other technologies). The patient's smart device receives information about the physician's decision, which the physician makes after receiving the information processed on the server (4) to the physician's smart device (3). The graphical user interface of the patient smart device (Figure 5) (24) allows the patient to monitor electrolyte fluctuations, independently enter physician-relevant information (25), and receive reminders important to maintain the patient's stable condition (26). The physician is provided with detailed information on the occurrence and progression of life-threatening arrhythmias during long-term follow-up and the relationship with electrolyte fluctuations, patient behavior (eg physical activity, body position, etc.) via the graphical user interface of the physician's smart device (Figure 6) (27). , food intake, physiological state (e.g., sleep, stress), and so on. The physician can perform a detailed analysis of the patient's condition (28) and see the patient's risk of sudden death (29) in the graphical user interface of the smart device.

In order to illustrate and describe the present invention, a description of the most preferred embodiments is provided above. It is not an exhaustive or restrictive description intended to determine the exact form or embodiment. the above description should be considered as an illustration rather than as a limitation. It will be appreciated that many modifications and variations may be apparent to those skilled in the art. An embodiment is selected and described to enable those skilled in the art to understand the principles of the present invention and their best practice for different embodiments with different modifications suitable for a particular use or application. It is intended that the scope of the invention be defined by the definition appended thereto and its equivalents, in which all the above-mentioned terms have a broad meaning, unless otherwise indicated.

Modifications may be made to the embodiments described by those skilled in the art without departing from the scope of the present invention, as defined below.