CN117530667A - Cardiac monitoring system and method - Google Patents

Cardiac monitoring system and method Download PDF

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Publication number
CN117530667A
CN117530667A CN202311536328.0A CN202311536328A CN117530667A CN 117530667 A CN117530667 A CN 117530667A CN 202311536328 A CN202311536328 A CN 202311536328A CN 117530667 A CN117530667 A CN 117530667A
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China
Prior art keywords
data
implantable medical
heart
medical device
module
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CN202311536328.0A
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Chinese (zh)
Inventor
马亦嘉
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Suzhou Weisi Medical Technology Co ltd
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Suzhou Weisi Medical Technology Co ltd
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Priority to CN202311536328.0A priority Critical patent/CN117530667A/en
Publication of CN117530667A publication Critical patent/CN117530667A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/321Accessories or supplementary instruments therefor, e.g. cord hangers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0204Operational features of power management
    • A61B2560/0214Operational features of power management of power generation or supply
    • A61B2560/0219Operational features of power management of power generation or supply of externally powered implanted units

Abstract

The application belongs to the field of medical equipment, and provides a heart monitoring system and a method, wherein the system comprises: the implantable medical device comprises a heart monitoring module, a data storage module and a power supply module, wherein the heart monitoring module is used for acquiring heart state data and storing the heart state data in the data storage module, and the power supply module comprises at least one wireless rechargeable battery; the charging communication device is used for wirelessly charging a wireless rechargeable battery of the implantable medical device, and is also used for wirelessly communicating with the implantable medical device to acquire the heart state data; and the in-vitro data management device is used for acquiring the heart state data from the charging communication device. The method and the device can acquire long-term heart state data while prolonging the service life of the implantable medical device.

Description

Cardiac monitoring system and method
Technical Field
The present application relates to the technical field of medical devices, and in particular, to a cardiac monitoring system and method.
Background
Implantable medical devices for cardiac monitoring are primarily used for treating patients suffering from acute episodes of malignant heart rhythms, and generally comprise an electrocardiographic electrode and an implantable host implanted in a human body. Because the implanted host is in a 24-hour monitoring state, the implanted host can identify the first time of malignant heart rhythm occurrence and apply electric defibrillation treatment, so that the life of a patient can be saved in time. However, due to the limitation of the volume and power consumption of the implantable medical device, in order to save energy consumption in the daily detection state, the implantable host only records the electrocardiographic signals before and after the malignant cardiac rhythm event, and the electrocardiographic signals at other times are discarded, so that long-term monitoring data cannot be stored.
In clinical need, after implantation of an implantable medical device, it is still generally necessary to monitor the progress of a patient's condition for a long period of time and track the patient's electrocardiographic signals. However, current implantable medical devices do not have the function of storing long-term electrocardiographic signals. The medical staff can not obtain the electrocardiosignals during the non-malignant heart rhythm event, which is inconvenient for the doctor to track and manage the course of the patient for a long time and is inconvenient for the doctor to adjust the medicine and the treatment scheme of the patient in time.
Disclosure of Invention
Aiming at the problems in the prior art, the purpose of the application is to provide a heart monitoring system and a method, which can acquire long-term heart state data while prolonging the service life of implantable medical equipment, and is convenient for doctors to track and manage the course of a patient for a long time.
The embodiment of the application provides a heart monitoring system, which comprises:
the implantable medical device comprises a heart monitoring module, a data storage module and a power supply module, wherein the heart monitoring module is used for acquiring heart state data and storing the heart state data in the data storage module, and the power supply module comprises at least one wireless rechargeable battery;
the charging communication device is used for wirelessly charging a wireless rechargeable battery of the implantable medical device, and is also used for wirelessly communicating with the implantable medical device to acquire the heart state data;
And the in-vitro data management device is used for acquiring the heart state data from the charging communication device.
In some embodiments, the charging communication device is configured to, when performing a wireless charging task, charge the implantable medical device and wirelessly communicate with the implantable medical device to perform a first data transmission task; the first data transmission task includes acquiring the cardiac state data from the implantable medical device.
In some embodiments, when the charging communication device is configured to perform the wireless charging task, wireless communication is performed with the implantable medical device by using a wireless charging carrier, where the wireless communication is implemented based on a preset multiplexing mode and/or modulation mode.
In some embodiments, the extracorporeal data management apparatus is further configured to send apparatus configuration information to the implantable medical apparatus via the charging communication apparatus, the apparatus configuration information including cardiac monitoring acquisition parameters and/or data storage parameters;
the implantable medical device further comprises a configuration module for configuring cardiac monitoring acquisition parameters of the cardiac monitoring module and/or data storage parameters of the data storage module according to the received device configuration information.
In some embodiments, the charging communication device is configured to wirelessly communicate with the implantable medical device upon receipt of a data transmission instruction to perform a second data transmission task; the second data transmission task includes the charging communication device transmitting the device configuration information to the implantable medical device.
In some embodiments, the system further includes a cloud server, where the in-vitro data management device is further configured to send the heart status data to the cloud server, and the cloud server is further configured to process the heart status data according to a preset processing rule, and send the processed data to a first user terminal;
the first user terminal comprises a doctor terminal, and the cloud server is further used for acquiring the equipment configuration information from the appointed doctor terminal and sending the equipment configuration information to the implantable medical equipment through the external data management equipment.
In some embodiments, the cloud server sends the processed data to the first client, including: the cloud server responds to a data viewing request of the first user side, acquires viewing authority and operation authority of the first user side, generates a data display interface and pushes the data display interface to the first user side, wherein the data display interface comprises a display area and an operation area, heart state data corresponding to the viewing authority is displayed in the display area, and the operation area displays an operation inlet corresponding to the operation authority;
The cloud server is further configured to respond to an operation of the first user side in the operation area.
In some embodiments, the processing, by the cloud server, the cardiac state data according to a preset processing rule includes: the cloud server groups the heart state data according to specified dimensions, and determines a second user side corresponding to each group of heart state data from the first user side;
the cloud server processes the heart state data according to a preset processing rule and further comprises: the cloud server determines a corresponding data pushing mode according to the category of the heart state data, and sends a viewing prompt to a second user terminal corresponding to the heart state data, wherein the viewing prompt is sent by adopting the data pushing mode;
the cloud server sends a viewing prompt to a second user side corresponding to the heart state data, and the method comprises the following steps: and when the cloud server determines that the same second user side has a plurality of groups of viewing reminders to be sent, sorting according to the push priority of the viewing reminders, and sending the sorted viewing reminders to the second user side.
In some embodiments, the cloud server is further configured to establish a communication connection between two different first clients associated with the implantable medical device based on a request of the first clients associated with the implantable medical device.
In some embodiments, the implantable medical device further comprises an alarm module for generating alarm information when the implantable medical device generates a preset type of alarm event, the alarm module further being configured to send the alarm information to the cloud server through the external data management device, the alarm information including a level of the generated alarm event and a response requirement.
In some embodiments, the implantable medical device further comprises a power management module for storing a correspondence of each remaining power level to each functional mode; the power management module is further configured to monitor a remaining power of the power module, determine a current remaining power level according to the remaining power, determine a functional mode corresponding to the remaining power level, and execute a power management scheme under the functional mode, where the power management scheme includes a switch control scheme of each module and/or an execution parameter control scheme of each module.
The embodiment of the application also provides a heart monitoring method which is realized based on the heart monitoring system, and comprises the following steps:
a heart monitoring module of the implantable medical device collects heart status data;
the charging communication device is in wireless communication with the implantable medical device to acquire the heart state data;
the extracorporeal data management apparatus obtains the heart status data from the charging communication apparatus.
The heart monitoring system and the method provided by the application have the following advantages:
according to the method, the charging communication equipment and the external data management equipment are provided, wireless charging can be conducted on the implantable medical equipment to prolong the service life of the implantable medical equipment, heart state data in the implantable medical equipment can be acquired according to monitoring requirements, and the heart state data are exported to the external data management equipment through data transmission of the charging communication equipment, so that long-term heart monitoring data can be acquired. The implantable medical device can meet the requirements of long service time and long-term data storage without setting a large power module and a large data management module, is beneficial to reducing the volume and hardware cost of the implantable medical device, and greatly improves the use experience of a user.
Drawings
Other features, objects and advantages of the present application will become more apparent upon reading of the detailed description of non-limiting embodiments, made with reference to the following drawings.
FIG. 1 is a block diagram of a cardiac monitoring system of the present application;
FIG. 2 is a block diagram of a cardiac monitoring system according to an embodiment of the present application;
FIG. 3 is a block diagram of an implantable medical device according to an embodiment of the present application;
fig. 4 is a flow chart of a cardiac monitoring method according to an embodiment of the present application.
Detailed Description
Example embodiments will now be described more fully with reference to the accompanying drawings. However, the exemplary embodiments can be embodied in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of the example embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and thus a repetitive description thereof will be omitted. "or", "or" in the specification may each mean "and" or ". Although the terms "first" or "second" etc. may be used herein to describe certain features, these features should be interpreted in a descriptive sense only and not for purposes of limitation as to the number and importance of the particular features.
As shown in fig. 1, the present application provides a cardiac monitoring system including an implantable medical device M100, a charging communication device M200, and an extracorporeal data management device M300. The implantable medical device M100 may include an electrocardio electrode implanted in a body and an implantable host. The implantable host is internally provided with each functional module of the implantable medical device M100. Specifically, the implantable medical device M100 includes a cardiac monitoring module, a data storage module, and a power module. The heart monitoring module is used for acquiring heart state data through the electrocardio electrodes and storing the heart state data in the data storage module, wherein the heart state data comprises electrocardio signals acquired by the electrocardio electrodes, and in some embodiments, the heart state data can also comprise heart sound data, heart cavity pressure data, lung water detection data and the like. The power module is configured to power the implantable medical device M100, and includes at least one wireless rechargeable battery. The charging communication device M200 mainly has two functions. First, the charging communication device M200 is configured to wirelessly charge the wireless rechargeable battery of the implantable medical device M100, so as to prolong the service life of the implantable host, so that the implantable host can last longer without being equipped with a battery with a particularly large volume. Secondly, the charging communication device M200 is further configured to wirelessly communicate with the implantable medical device M100 to obtain the cardiac status data, and send the cardiac status data to the extracorporeal data management device M300, so that the cardiac status data in the implantable medical device M100 can be obtained as required, and the data storage module in the implantable medical device M100 does not need to store excessive data, and long-term cardiac status data can also be obtained as required through the charging communication device M200. The two functions of the charging communication device M200 and the cooperation of the charging communication device M with the external data management device M300 are integrated, and the requirements of service time and data storage can be met without arranging a large power module and a large data management module in the implanted medical device M100, so that the hardware configuration of the implanted medical device M100 is minimized, the cost advantage is obvious, and the use experience of a user is greatly improved.
Fig. 2 shows the structure of a cardiac monitoring system according to an embodiment of the present application, and fig. 3 shows the structure of an implantable medical device M100 according to the embodiment. In this embodiment, the implantable medical device M100 further includes a wireless communication module that wirelessly communicates with the charging communication device M200. The charging communication device M200 may be a wireless charging patch with a wireless charging coil, which may be attached to the chest body surface of the user, and when in use, is close to the implantable medical device M100, and may automatically detect the implantable medical device M100, and charge the implantable medical device M100 and transmit data with the implantable medical device M100. The charging of the implantable medical device M100 by the charging communication device M200 may be performed periodically, or may be performed by sending a charging command to the external data management device M300, or may be started by a button controlling the surface of the charging communication device M200, as needed. The charging communication device M200 may be equipped with a rechargeable battery therein, or the charging communication device M200 may maintain a wired connection with the external data management device M300 as a power supply, or the charging communication device M200 may be directly connected to the utility power.
The external data management device M300 may be a hardware device including a housing and a controller inside the housing, and the charging communication device M200 and the external data management device M300 may communicate with each other through wireless communication or wired communication. If necessary, the external data management device M300 may also directly communicate with the wireless communication module of the implantable medical device M100, but if not directly communicate with the wireless communication module, it is also within the scope of the present application.
As shown in fig. 2, the cardiac monitoring system further includes a cloud server M400, the in-vitro data management device M300 is further configured to send the cardiac status data to the cloud server M400, and the cloud server M400 is further configured to process the cardiac status data according to a preset processing rule, and send the processed data to the first user side. The in-vitro data management device M300 and the cloud server M400 may communicate with each other wirelessly or by wire. The cloud server M400 and the first user end may be in wireless or wired communication. The first user side may include, for example, a doctor side, a patient side, and/or a patient family side, among others. The first user side refers to terminal equipment used by a user or a software side (an APP (application) of a mobile phone, a web page side and the like) corresponding to the user. The processing according to the preset processing rules can include, for example, grouping the heart state data according to different dimensions of a patient, time, region and/or type, performing data format adjustment on the heart state data, and the like. The cloud server M400 may process the heart status data of a patient and send the processed heart status data to a doctor end, a patient end and/or a patient family end corresponding to the patient. Through the data integration function of the cloud server M400 of the system, big data medical treatment is possible, and the cloud server M400 can conduct screening classification according to patient data, so that an analysis prediction report is provided for doctors, and the development progress of the patient diseases is prompted.
In this embodiment, the processing, by the cloud server M400, the cardiac status data according to a preset processing rule includes: the cloud server M400 groups the heart status data according to specified dimensions (such as patient, time, region and/or category, etc.), so as to obtain a plurality of groups of heart status data, and determines a second user terminal corresponding to each group of heart status data from the first user terminals, that is, the second user terminal is selected from the first user terminals and is associated with each group of heart status data. For example, for cardiac state data grouped in patient dimensions, the second user side corresponding to the cardiac state data of a particular patient includes a doctor side corresponding to the patient, a patient side, and a patient family side, where the doctor side refers to a doctor side used by a designated doctor, and the designated doctor refers to a particular doctor responsible for the patient; for heart state data grouped in regional dimensions, a second user end corresponding to the heart state data of a specific region comprises a staff end responsible for managing the regional data; the heart status data classified by type, the second user side corresponding to the heart status data of a specific type comprises a staff side needing trend analysis by using the heart status data of the specific type.
In this embodiment, after the cloud server M400 groups the cardiac status data according to specified dimensions (such as patient, time, region and/or category, etc.), a doctor may choose to view cardiac status data in one or more dimensions when the doctor is viewing the cardiac status data. For example, in a data display interface pushed to a doctor terminal, a drop-down selection frame of each dimension is displayed, and the doctor terminal can select a specific dimension in the drop-down selection frame of each dimension, so that the purpose of viewing heart state data of a specific dimension is achieved.
In this embodiment, after determining the second user end corresponding to each group of the cardiac status data, the cloud server M400 further determines a corresponding data pushing mode according to the category of the cardiac status data, and sends a viewing reminder to the second user end corresponding to the cardiac status data, where the viewing reminder is sent in the data pushing mode. The viewing reminding can be, for example, a mail, a short message or a WeChat reminding sent to the second user side, or a popup reminding jumped out at the second user side. The viewing reminder includes a brief introduction of the data to be pushed (such as a patient name, a data type, or a data generation time) and a link of the data to be pushed. After receiving the viewing prompt, the user can click on the link in the viewing prompt, namely, initiate a data viewing request to the cloud server M400.
The cloud server M400 sends the processed data to the first user terminal, including: the cloud server M400 responds to the data viewing request of the first user side, obtains viewing authority and operation authority of the first user side, generates a data display interface and pushes the data display interface to the first user side, wherein the data display interface comprises a display area and an operation area, the display area displays the viewing authority to determine corresponding heart state data, and the operation area displays an operation entry corresponding to the operation authority, and the operation entry comprises an operation button. The cloud server M400 is further configured to respond to the operation of the first user side in the operation area, and execute a data processing task corresponding to the operation. For example, if the viewing authority of a doctor is the heart status data of the associated patient, the heart status data of the associated patient is displayed in the display area. The operation authority of the doctor end comprises, for example, checking, screening and/or marking the heart state data, generating a heart state data analysis report, setting equipment configuration information of medical equipment of a certain patient, and prescribing consultation time with a certain patient, etc., and then generating a data display interface for the doctor end, wherein the operation area of the data display interface is also provided with corresponding entries of the operations.
In this embodiment, different data display interface templates are configured for the first user ends of the various operation rights in advance, and the cloud server M400 stores the data display interface templates corresponding to the first user ends of the various operation rights. For example, a data display interface template corresponding to a doctor end, a data display interface template corresponding to a patient end, and a data display interface template corresponding to a staff end are preset, and when receiving a data viewing request of a first user end, the cloud server M400 generates a data display interface, which includes: and calling a corresponding data display interface template according to the operation authority of the first user side, wherein the data display interface template comprises an operation area and a display area, and the operation area displays an operation inlet corresponding to the operation authority. And then the cloud server M400 invokes heart state data which can be checked by the first user terminal according to the checking authority of the first user terminal, fills the invoked heart state data into the display area of the data display interface template, and obtains a data display interface corresponding to the first user terminal, and then pushes the data display interface to the first user terminal. Further, the doctor may select the heart status data to be checked through the doctor terminal, and the cloud server M400 invokes the heart status data to be checked (satisfying that the first user terminal has the checking authority) according to the selection of the first user terminal, and fills the display area of the data display interface template.
For example, the designated doctor may use the terminal device or log in the doctor terminal on the web page, and after receiving the viewing prompt, select the data to be viewed and click on the corresponding link, and send a data viewing request to the cloud server M400. The cloud server M400 pushes the data display interface to the doctor end, and the doctor end can view the data of the patient in the display area. The designated doctor can find an operation entry for setting device configuration information in the operation area, click on a configuration interface for entering the device configuration information, and adjust the device configuration information of the implanted medical device M100 thereof in the configuration interface according to the condition of the patient. If the doctor wants to see the electrocardiographic parameters of the patient for the next three days, the doctor can configure corresponding heart monitoring parameters in the equipment configuration information through the doctor side. The device configuration information can remotely configure the implanted host through paths of the doctor end, the cloud server M400, the extracorporeal data management device M300 and the implanted medical device M100. Therefore, by adopting the heart monitoring system, accurate heart state data can be obtained based on the implanted medical device M100, and detection tracking and disease course management of heart disease progress of a patient at a doctor end and/or a patient end can be satisfied. So that the patients can fully benefit after the implantation operation and systematically treat and manage heart diseases. Not only the life of the patient is guarded for 24 hours, but also doctors can administer reasonable medicines according to the development of the illness state of the patient.
In this embodiment, different categories of the heart state data correspond to different data push modes. For example, the cloud server M400 classifies the heart state data into two categories: category a is cardiac state data of the implantable medical device before and after treatment, which is generated during a treatment process after a patient has a specific cardiac rhythm event; and B category is heart state data acquired by the implantable medical device for a long time according to the device configuration information. The data pushing mode of the class A data is set to be immediately pushed to a designated doctor side, the class B data pushing mode is that when the data quantity or the acquisition time of the heart state data meets pushing requirements, the part of the heart state data is processed based on a preset integration analysis strategy, after a data analysis report is obtained, the viewing reminding of the data analysis report is pushed to the designated doctor side, and the integration analysis strategy comprises calculation of heart state parameters, comparison analysis of the heart state data in different time periods, trend analysis of heart state parameter change, graphical processing of heart state parameter change trend and the like.
For example, whenever a patient in the jurisdiction of a doctor has heart status data of category a, a viewing reminder of the data is immediately pushed to the doctor's end for use by the doctor, and the instant pushing manner may include sending a sms, email, or pop-up window, etc., to require the doctor to view and process the data within a specified time. If the doctor does not check, the doctor is reminded in a certain period cycle, so that the doctor is ensured to receive the data.
For class B heart condition data, the cloud server M400 automatically analyzes the heart condition data for each long-term recording, classifies and records the frequency of various heart rhythm events (such as malignant heart rate, atrial fibrillation, atrial premature, ventricular superior speed, ventricular premature and/or other non-malignant heart rhythm events), and records various parameters of sinus rhythm (R-R interval, R wave amplitude, QRS interval and the like) in the time period. Meanwhile, for patients with multiple sections of long-time heart state data, the cloud server M400 can compare data values in the front and back multiple sections of heart state data, and after a data analysis report showing a change trend is obtained, a viewing prompt of the data analysis report is pushed to a designated doctor end in the form of a short message, a mail, a popup window and the like, and the doctor can click to view the complete data analysis report.
In application, when one doctor faces multiple patients at the same time, there may be a case where a plurality of groups of heart status data of different patients need to be pushed to the doctor at the same time. In this embodiment, in order to facilitate the doctor to view the patient data with more urgent situation in time, the cloud server M400 may prioritize the viewing reminders to be sent in advance, so as to facilitate the doctor to view. The priority sorting mode may be according to a default priority sorting rule, where the default priority sorting rule may be a unified rule, or different types of first user ends respectively correspond to different priority sorting rules. In some embodiments, the prioritization manner may also be according to a prioritization rule set by a doctor, for example, the doctor may select some patients, and make the viewing reminders corresponding to the patients set on top, so that the push priority of the viewing reminders of the patients is higher. Specifically, the cloud server M400 sends a viewing reminder to a second user side corresponding to the cardiac status data, including: when the cloud server M400 determines that the same second user side has multiple groups of viewing reminders to be sent, sorting the viewing reminders according to the push priorities of the viewing reminders, sending the sorted viewing reminders to the second user side, and highlighting or placing the viewing reminders with high push priorities on the forefront side to push the viewing reminders to the doctor side so as to first draw attention of the doctor. Therefore, when receiving a plurality of viewing reminders, the doctor terminal can purposefully and preferentially view the viewing reminders with high pushing priority and click to view the corresponding heart state data, so that the processing of an emergency is prevented from being delayed. The prioritization rules herein order, for example, from high to low based on the push priority of the view reminder, which may be based on a weighted summation of attribute values of a plurality of attributes, which may include the category of heart status data (e.g., category a or category B described above), the patient's chance of developing, the time at which the patient has most recently occurred a malignant heart rhythm event, the number of malignant heart rhythm events that have occurred in the most recent period of time, and the like.
In this embodiment, the implantable medical device M100 is exemplified as an implantable cardiac defibrillator. As shown in fig. 3, the implantable medical device M100 further includes a heart rhythm analysis module and a heart treatment module. The heart rhythm analysis module is used for judging whether a specific heart rhythm event occurs according to the heart state data, for example, the heart rhythm event is identified according to preset judging conditions of the heart rhythm event. The cardiac therapy module is configured to perform a therapeutic action, such as electrical defibrillation therapy of the patient's heart using defibrillation electrodes, when a particular cardiac rhythm event is determined to occur, and to cardiovert the patient's heart when current is passed through the cardiomyocytes. In existing implantable cardiac defibrillators, only a few minutes of cardiac state data before and after a malignant cardiac rhythm event is saved, and therefore the cardiac state data may be quickly overlaid periodically to fail to save long-term continuous monitoring data. In this embodiment, the data storage parameters of the data storage module are set by the device configuration information, so that the data storage module can record all cardiac state data for a specified duration periodically or aperiodically. For example, 24-hour weekly cardiac state data is stored, or 24-hour weekly cardiac state data is stored for two-day/one-month/three-day/month, etc. The starting time of the period of the data storage record may also be arbitrarily configured.
In this embodiment, the extracorporeal data management apparatus M300 is further configured to send apparatus configuration information to the implantable medical apparatus M100 via the charging communication apparatus M200, the apparatus configuration information including cardiac monitoring acquisition parameters and/or data storage parameters. The device configuration information is generally set by a designated doctor according to the condition of the patient, and may be directly transmitted by the designated doctor through operation on the external data management device M300, or may be transmitted to the cloud server M400 by the designated doctor through a doctor end, and then the cloud server M400 transmits to the external data management device M300. For example, the cloud server M400 is further configured to obtain the device configuration information from a doctor end, and send the device configuration information to the implantable medical device M100 through the extracorporeal data management device M300. Therefore, the doctor end can not only follow the progress of the patient's condition in real time, but also can remotely set parameters such as the monitoring duration and the monitoring period of the implantable medical device M100.
As shown in fig. 3, the implantable medical device M100 further includes a configuration module configured to configure the cardiac monitoring acquisition parameters of the cardiac monitoring module and/or the data storage parameters of the data storage module according to the received device configuration information. The cardiac monitoring acquisition parameters include, for example, one or more of parameters such as an acquisition frequency of the cardiac monitoring module, an acquisition time point of the cardiac monitoring module (e.g., 3 pm per day/day of the end of each month 5, etc.), and/or an acquisition duration of the cardiac monitoring module (e.g., 24 hours per day/8 a early day to 8 a late day, etc.), the data storage parameters include, for example, one or more of a frequency with which the data storage module stores the cardiac state data (e.g., once per month/three times per month, etc.), a time period during which the cardiac state data is stored (e.g., 24 hours per time of storage/6 hours per time of storage, etc.), what cardiac state data is stored, or what amount of data is cleaned up, etc.
In this embodiment, the device configuration information may further include a specific cardiac rhythm event determination parameter and/or a cardiac therapy parameter, where the specific cardiac rhythm event determination parameter is a specific cardiac rhythm event determination parameter of the cardiac rhythm analysis module, and the cardiac therapy parameter is a cardiac therapy parameter of the cardiac therapy module. The configuration module of the implantable medical device M100 is further configured to configure the specific cardiac rhythm event decision parameters of the cardiac rhythm analysis module and/or the cardiac treatment parameters of the cardiac treatment module according to the received device configuration information. The cardiac rhythm event determination parameters include, for example, a determination that the cardiac rhythm is in a normal range, a ventricular rate occurs, a numerical range of a specific electrocardiographic indicator at the time of ventricular fibrillation occurs, a determination condition of a specific electrocardiographic event requiring initiation of treatment, and the like. The cardiac therapy parameters include, for example, voltage variation parameters and/or therapy time parameters when delivering electrical defibrillation therapy, and the like.
In this embodiment, the wireless communication/wireless charging operation modes between the charging communication device M200 and the implanted medical device M100 are, for example, two types:
(1) When the charging communication device M200 performs a wireless charging task, the charging communication device M200 performs wireless charging on a wireless rechargeable battery of the implanted medical device M100 and performs wireless communication with the implanted medical device M100 to perform a first data transmission task. In this embodiment, the first data transmission task includes acquiring the heart status data from the implantable medical device M100. Because the heart state data often has larger data volume, wireless data transmission is carried out simultaneously in the wireless charging process, excessive loss caused by the residual electric quantity of the power module of the implantable medical device M100 can be avoided, rapid decline of the electric quantity of the implantable medical device M100 caused by data transmission is avoided, and the reliability and stability of the data transmission are improved.
In this embodiment, when the charging communication device M200 performs the wireless charging task, wireless communication with the implanted medical device M100 may be performed using a wireless charged carrier, that is, communication data is loaded on the wireless charged carrier. In this embodiment, when the charging communication device M200 performs the wireless charging task, the wireless charging process and the wireless communication process between the charging communication device M200 and the implanted medical device M100 are controlled based on a specific control manner. The specific control mode comprises a preset multiplexing mode and/or a preset modulation mode. The multiplexing method includes, for example, a time division control method, a frequency division control method, or a time division and frequency division mixed control method, and the modulation method includes, for example, ASK (Amplitude Shift Keying, amplitude shift keying modulation), PSK (Phase Shift Keying, phase shift keying modulation), and/or FSK (Frequency Shift Keying, frequency shift keying modulation). For example, the wireless charging process and the wireless communication process between the charging communication device M200 and the implanted medical device M100 use the same transmission path, and both processes are performed according to a time division control manner or a frequency division control manner.
(2) The charging communication device M200 performs wireless communication with the implantable medical device M100 when receiving a data transmission instruction to perform a second data transmission task. The data transmission instruction may be sent to the charging communication device M200 through the external data management device M300, or may be sent by a user through a button controlling the surface of the charging communication device M200. In this embodiment, the second data transmission task includes the charging communication device M200 transmitting the device configuration information to the implantable medical device M100. Because the device configuration information is generally set by a doctor according to the condition of a patient, the setting time and the wireless charging time are not necessarily consistent, and the flexible transmission of the device configuration information can be realized by transmitting a data transmission instruction, so that the relevant parameters of the implantable medical device M100 can be configured timely according to the instruction of the doctor.
In another embodiment, when the charging communication device M200 performs the wireless charging task, if there is just device configuration information to be transmitted, the device configuration information may also be sent to the implantable medical device M100 at the same time; and/or, the charging communication device M200 acquires heart status data from the implantable medical device M100 upon receiving a data transmission instruction, where the data transmission instruction may further include further refined information such as a data type and/or a time range of acquisition of the heart status data.
In this embodiment, the cloud server M400 is further configured to establish a communication connection between two different first clients associated with the implantable medical device M100 based on a request of the first clients associated with the implantable medical device M100. For example, if one of the implantable medical devices M100 is associated with both the patient side and the doctor side, the cloud server M400 may establish a communication connection between the patient side and the doctor side, where the communication connection may be in the form of text/picture/audio/video communication in the form of a dialog box, or may be a direct voice call/video call, or the like. Therefore, the cloud server M400 may integrate the internet hospital functions, so that the designated doctor and the patient may communicate and communicate in time through a direct communication manner, the designated doctor may prescribe the patient in time, adjust the device configuration parameters of the implanted medical device M100, and the patient may also query his own diagnosis and treatment scheme in time. Therefore, the embodiment can realize absolute remote follow-up of the patient, save a plurality of inconveniences of the patient to the hospital, improve the medical efficiency and promote the experience of seeking doctor.
As shown in fig. 3, in this embodiment, the implantable medical device M100 further includes an alarm module for determining a level of an alarm event and a response requirement that occurs when the implantable medical device M100 has a preset type of alarm event. For example, the alarm event is highest when the implantable medical device M100 encounters a significant abnormality, which affects the protection function of the implantable medical device M100 for the patient, and is lowest when the implantable medical device M100 has a low battery but has not reached an extremely low level, and the alarm event is medium, when the implantable medical device M100 has a small malfunction but does not affect normal use for a short time. The alarm module is further configured to send alarm information to the cloud server M400 via the extracorporeal data management apparatus M300, where the alarm information includes a level of an alarm event occurring and a response requirement, where the response requirement includes, for example, a response personnel range (doctor, patient family and/or emergency personnel, etc.), a response time requirement (immediate response or response within 30 minutes, etc.), and/or a response mode requirement (patient immediately sees doctor or patient family immediately assists, etc.). The alarm information may also include data related to the occurrence of an alarm event, such as operational data of the alarm module and/or current time cardiac state data, etc. The alarm information may be sent directly to the external data management device M300 by the implanted medical device M100 in a wireless manner when an alarm event occurs, or the implanted medical device M100 may be sent to the external data management device M300 by the charging communication device M200. Alternatively, considering that the in-vitro data management device M300 is not necessarily disposed around the implantable medical device M100 in real time, the implantable medical device M100 generates alarm information when an alarm event occurs and stores the alarm information locally, and transmits the locally stored alarm information to the in-vitro data management device M300 when communicating with the in-vitro data management device M300. After receiving the alarm information, the cloud server M400 sends the alarm information to the corresponding first user end according to the level and response requirement of the alarm event, where the corresponding first user end is the first user end associated with the implanted medical device M100 having the alarm event. When receiving the alarm information, the doctor end can reserve corresponding medical resources (including 120 emergency ambulances or hospital visit green channels and the like) in time to respond to the emergency requirement of the patient.
In this embodiment, the power module may have other types of batteries, such as a non-rechargeable battery, in addition to the rechargeable battery, or the power module may be all rechargeable batteries. The power module may be divided into a plurality of battery partitions, each battery partition including at least one rechargeable battery and/or at least one non-rechargeable battery, each battery partition powering a different functional module. As shown in fig. 3, in this embodiment, the implantable medical device M100 further includes a power management module. The power management module can manage each battery partition, monitor the residual electric quantity of each battery partition, and adjust the corresponding power supply relation between the battery partition and the functional module according to the residual electric quantity of each battery partition.
In this embodiment, the power management module is configured to store a correspondence between each remaining power level and each functional mode. The power management module is further configured to monitor a remaining power of the power module, determine a current remaining power level according to the remaining power, determine a functional mode corresponding to the remaining power level, and execute a power management scheme under the functional mode, where the power management scheme includes a switch control scheme of each module and/or a control scheme of a function execution parameter of each module (a heart monitoring parameter of the heart monitoring module, a data storage parameter of the data storage module, and/or a heart treatment parameter of the heart treatment module). For example, when the power module is not partitioned, the power management module monitors the remaining power of the power module as a whole. The remaining power level is classified into three levels, for example: sufficient electric quantity, low electric quantity and extremely low electric quantity. When the electric quantity is sufficient, the power management scheme under the corresponding functional mode can comprise that all functional modules work normally, wherein the heart monitoring module acquires heart state data with higher frequency and precision; when the electric quantity is low, the power management scheme in the corresponding functional mode can comprise the functions of closing the wireless communication module and the configuration module; when the electric quantity is extremely low, the power management scheme in the corresponding functional mode can comprise the functions of closing the wireless communication module, the configuration module and the data storage module, and setting the heart monitoring module to collect heart state data with lower frequency and accuracy, wherein the corresponding relation between the residual electric quantity classification and the power management scheme is only an example.
In one embodiment, the power management module presets a plurality of functional modes, including, for example, the following five functional modes:
(I) Core functional mode: the mode mainly realizes the functions of heart state data acquisition, heart state data analysis, malignant heart rhythm event identification, treatment starting, power management and charging prompt alarm, and the power management scheme corresponding to the functional mode is as follows: starting the functions of a heart monitoring module, a heart rhythm analysis module, a heart treatment module, a power supply module and an alarm module, and controlling the started modules to work according to preset heart monitoring parameters, malignant heart rhythm event judgment conditions, heart treatment parameters and charging prompt alarm thresholds;
(II) treatment recording functional mode: the mode mainly realizes the recording of heart state data and medical equipment parameters before and after the treatment process, and the power management scheme corresponding to the functional mode is as follows: starting the function of the data storage module, and storing the acquired heart state data and medical equipment parameters according to preset data storage parameters;
(III) device operating parameter monitoring functional mode: the mode mainly realizes the self-checking and alarming record of the medical equipment to detect the daily working state of the medical equipment, and the power management scheme corresponding to the functional mode is as follows: starting the functions of the equipment self-checking module and the data storage module;
(IV) wireless communication functional mode: the mode mainly realizes the communication between the medical equipment and the charging communication equipment, and the power management scheme corresponding to the functional mode is as follows: starting the function of the wireless communication module;
(V) long-time signal acquisition functional mode: the mode mainly realizes the collection and storage of long-time heart state data, and the power management scheme corresponding to the functional mode is as follows: and starting the functions of the heart monitoring module and the data storage module, and controlling the heart monitoring module according to the configured acquisition frequency, acquisition precision and continuous acquisition time of long-time data acquisition.
The priorities of the five functional modes decrease in sequence. When the remaining power is high, all functional modes can be turned on. When the electric quantity is low, the implementation of the function mode with high priority is ensured first, and the function mode with low priority can be correspondingly closed. The remaining power level and the functional mode may be in a one-to-one, one-to-many, or many-to-one relationship. For example, five remaining power levels 1-5 are set in the power management module, the corresponding remaining power ranges are sequentially reduced, the remaining power level 1 corresponds to the function modes I, II, III, IV and V, the remaining power level 2 corresponds to the function modes I, II, III and IV, that is, the power management scheme of the long-time signal acquisition function mode is not executed any more, the remaining power level 3 corresponds to the function modes I, II and III, the remaining power level 4 corresponds to the function modes I and II, the remaining power level 5 corresponds to the function mode I, that is, when the power is very low, only the normal execution of the power management scheme of the function mode I is preferentially ensured.
As shown in fig. 4, an embodiment of the present application further provides a cardiac monitoring method, implemented based on the cardiac monitoring system, where the method includes the following steps:
s100: a heart monitoring module of the implantable medical device collects heart status data;
s200: the charging communication device is in wireless communication with the implantable medical device to acquire the heart state data;
s300: the extracorporeal data management apparatus obtains the heart status data from the charging communication apparatus.
Since the cardiac monitoring method is implemented by using the cardiac monitoring system, the specific implementation manner of each step of the cardiac monitoring method may be implemented by using the exemplary manner of the foregoing embodiment, and the beneficial effects of the cardiac monitoring system may be obtained, which are not described herein.
In the present application, the manner of wireless communication between the devices is not limited, and may be near field communication or far field communication, and the communication protocol may be WIFI, 4G, bluetooth, infrared, 5G, or the like, for example. The cardiac state data transmitted between different devices can comprise electrocardiosignals acquired by the cardiac monitoring module at a certain frequency, electrocardiosignal data before and after malignant heart rhythm, electrocardiosignal data stored in the data storage module for a long time and the like. The data transmission among different devices can be realized by adopting an encryption verification mode, so that the safety of the data transmission and the protection of the privacy of a patient are improved, and the data transmission is not tamperable and real.
In the present application, the functional modules of the implantable medical device include, but are not limited to, one or more of the cardiac monitoring module, the data storage module, the heart rhythm analysis module, the cardiac therapy module, the configuration module, the alarm module, the wireless communication module, and the power module described above.
The foregoing is a further detailed description of the present application in connection with the specific preferred embodiments, and it is not intended that the practice of the present application be limited to such description. It should be understood that those skilled in the art to which the present application pertains may make several simple deductions or substitutions without departing from the spirit of the present application, and all such deductions or substitutions should be considered to be within the scope of the present application.

Claims (12)

1. A cardiac monitoring system, comprising:
the implantable medical device comprises a heart monitoring module, a data storage module and a power supply module, wherein the heart monitoring module is used for acquiring heart state data and storing the heart state data in the data storage module, and the power supply module comprises at least one rechargeable battery;
the charging communication device is used for wirelessly charging a wireless rechargeable battery of the implantable medical device, and is also used for wirelessly communicating with the implantable medical device to acquire the heart state data;
And the in-vitro data management device is used for acquiring the heart state data from the charging communication device.
2. The cardiac monitoring system of claim 1, wherein the charging communication device is configured to, when performing a wireless charging task, charge the implantable medical device and wirelessly communicate with the implantable medical device to perform a first data transmission task; the first data transmission task includes acquiring the cardiac state data from the implantable medical device.
3. The cardiac monitoring system of claim 2, wherein the charging communication device is configured to wirelessly communicate with the implantable medical device using a wirelessly charged carrier wave when performing the wireless charging task, the wireless communication being based on a preset multiplexing scheme and/or modulation scheme.
4. The cardiac monitoring system of claim 1, wherein the extracorporeal data management apparatus is further configured to send apparatus configuration information to the implantable medical apparatus via the charging communication apparatus, the apparatus configuration information including cardiac monitoring acquisition parameters and/or data storage parameters;
The implantable medical device further comprises a configuration module for configuring cardiac monitoring acquisition parameters of the cardiac monitoring module and/or data storage parameters of the data storage module according to the received device configuration information.
5. The cardiac monitoring system of claim 4, wherein the charging communication device is configured to wirelessly communicate with the implantable medical device to perform a second data transmission task upon receipt of a data transmission instruction; the second data transmission task includes the charging communication device transmitting the device configuration information to the implantable medical device.
6. The cardiac monitoring system of claim 4, further comprising a cloud server, wherein the in vitro data management device is further configured to send the cardiac status data to the cloud server, wherein the cloud server is further configured to process the cardiac status data according to a preset processing rule, and send the processed data to a first user terminal;
the first user terminal comprises a doctor terminal, and the cloud server is further used for acquiring the equipment configuration information from the appointed doctor terminal and sending the equipment configuration information to the implantable medical equipment through the external data management equipment.
7. The cardiac monitoring system of claim 6, wherein the cloud server sends the processed data to the first client, comprising: the cloud server responds to a data viewing request of the first user side, acquires viewing authority and operation authority of the first user side, generates a data display interface and pushes the data display interface to the first user side, wherein the data display interface comprises a display area and an operation area, heart state data corresponding to the viewing authority is displayed in the display area, and the operation area displays an operation inlet corresponding to the operation authority;
the cloud server is further configured to respond to an operation of the first user side in the operation area.
8. The cardiac monitoring system of claim 7, wherein the cloud server processes the cardiac state data according to a preset processing rule, comprising: the cloud server groups the heart state data according to specified dimensions, and determines a second user side corresponding to each group of heart state data from the first user side;
the cloud server processes the heart state data according to a preset processing rule and further comprises: the cloud server determines a corresponding data pushing mode according to the category of the heart state data, and sends a viewing prompt to a second user terminal corresponding to the heart state data, wherein the viewing prompt is sent by adopting the data pushing mode;
The cloud server sends a viewing prompt to a second user side corresponding to the heart state data, and the method comprises the following steps: and when the cloud server determines that the same second user side has a plurality of groups of viewing reminders to be sent, sorting according to the push priority of the viewing reminders, and sending the sorted viewing reminders to the second user side.
9. The cardiac monitoring system of claim 6, wherein the cloud server is further configured to establish a communication connection between two different first clients associated with the implantable medical device based on a request from the first clients associated with the implantable medical device.
10. The cardiac monitoring system of claim 6, wherein the implantable medical device further comprises an alarm module for generating alarm information when a preset type of alarm event occurs to the implantable medical device, the alarm module further configured to send the alarm information to the cloud server via the extracorporeal data management device, the alarm information including a level of the alarm event occurring and a response requirement.
11. The cardiac monitoring system of claim 1, wherein the implantable medical device further comprises a power management module for storing a correspondence of each remaining power level to each functional mode; the power management module is further configured to monitor a remaining power of the power module, determine a current remaining power level according to the remaining power, determine a functional mode corresponding to the remaining power level, and execute a power management scheme under the functional mode, where the power management scheme includes a switch control scheme of each module and/or an execution parameter control scheme of each module.
12. A cardiac monitoring method, characterized in that it is implemented on the basis of a cardiac monitoring system according to any one of claims 1 to 11, the method comprising the steps of:
a heart monitoring module of the implantable medical device collects heart status data;
the charging communication device is in wireless communication with the implantable medical device to acquire the heart state data;
the extracorporeal data management apparatus obtains the heart status data from the charging communication apparatus.
CN202311536328.0A 2023-11-17 2023-11-17 Cardiac monitoring system and method Pending CN117530667A (en)

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