CN114870259A - Wearable cardiac medical equipment, control method and medical system - Google Patents
Wearable cardiac medical equipment, control method and medical system Download PDFInfo
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- CN114870259A CN114870259A CN202210389370.3A CN202210389370A CN114870259A CN 114870259 A CN114870259 A CN 114870259A CN 202210389370 A CN202210389370 A CN 202210389370A CN 114870259 A CN114870259 A CN 114870259A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3925—Monitoring; Protecting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3968—Constructional arrangements, e.g. casings
Abstract
The invention provides wearable heart medical equipment, a control method and a medical system, wherein the wearable heart medical equipment comprises: a plurality of conductive electrodes; the controller is connected with the plurality of conductive electrodes and used for collecting heart monitoring data of the patient through the conductive electrodes in a heart monitoring mode, judging whether the heart treatment mode needs to be entered or not according to the heart monitoring data and delivering treatment to the patient through the conductive electrodes in the heart treatment mode. The wearable heart medical equipment has the advantages that the electrocardio acquisition and treatment share one set of conductive electrodes, the structure of the wearable heart medical equipment is simplified, the failure rate is reduced, and the wearing comfort and compliance of a patient are improved.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to wearable cardiac medical equipment, a control method and a medical system.
Background
Wearable Cardioverter Defibrillator (WCD), a Wearable extracorporeal automatic Defibrillator, delivers electrical shock therapy by itself without requiring bystander intervention after being worn, and a conscious patient can delay or terminate therapy by pressing a response button. WCD devices are used by patients outside the hospital for periods ranging from 3 days to 6 months. The electrocardio electrode is used for carrying out 24-hour electrocardio monitoring in the working state of the WCD host, and the WCD host switches to a defibrillation mode after detecting VF/VT (ventricular fibrillation or ventricular velocity) and confirming that a patient does not respond. And the defibrillation electrode plate sprays conductive adhesive to begin defibrillation.
In traditional wearable external automatic defibrillator, the used electrodes of electrocardio acquisition device and defibrillation device are two sets of electrodes independent of each other, and wearable external automatic defibrillator is structural complicated, connects more between wire and the electrode, and bad contact takes place easily in wire and electrode junction, also takes place the broken string easily to lead to the fault incidence higher. And because the structure is complicated, two sets of electrodes need to be fixed on the wearable device, and each set of electrodes needs to be provided with a plurality of electrodes, so that the patient feels uncomfortable during wearing, the wearing compliance of the patient is reduced, the wearable device is not beneficial to the long-period and continuous wearing of the patient, and the risk of sudden cardiac death is increased during the period that the patient does not wear the wearable device.
It is to be noted that the information disclosed in the above background section is only for enhancement of understanding of the background of the invention and therefore may include information that does not constitute prior art that is already known to a person of ordinary skill in the art.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide wearable cardiac medical equipment, a control method and a medical system.
The embodiment of the invention provides wearable heart medical equipment, which comprises:
a plurality of conductive electrodes;
the controller is connected with the plurality of conductive electrodes and used for collecting heart monitoring data of the patient through the conductive electrodes in a heart monitoring mode, judging whether the heart treatment mode needs to be entered or not according to the heart monitoring data and delivering treatment to the patient through the conductive electrodes in the heart treatment mode.
In some embodiments, in the cardiac monitoring mode, the controller is configured to obtain potential values from the conductive electrodes, obtain an electrical cardiac signal of the patient based on a potential difference between any two non-conductive electrodes, and generate the cardiac monitoring data based on the electrical cardiac signal.
In some embodiments, comprising N conductive electrodes, the controller generates the cardiac monitoring data from the cardiac electrical signal, including pairs
And performing signal quality evaluation on the electrocardiosignals of the signal channels, selecting the electrocardiosignals of which the signal quality evaluation meets the preset quality requirement, performing heart index analysis, and generating the heart monitoring data.
In some embodiments, the plurality of conductive electrodes comprises a first set of conductive electrodes comprising at least one conductive electrode and a second set of conductive electrodes comprising at least one conductive electrode; in the cardiac treatment mode, the controller controls all the conductive electrodes in the first group of conductive electrodes to be conducted with each other to be used as positive electrodes, controls all the conductive electrodes in the second group of conductive electrodes to be conducted with each other to be used as negative electrodes, and discharges and treats the patient through the first group of conductive electrodes and the second group of conductive electrodes.
In some embodiments, at least one first control switch is disposed in the first set of conductive electrodes and at least one second control switch is disposed in the second set of conductive electrodes;
the controller is used for controlling the first control switch and the second control switch to be switched off in an electrocardio monitoring mode so that all the conductive electrodes are not conducted, and controlling the first control switch and the second control switch to be switched on in a heart treatment mode so that the first group of conductive electrodes are conducted with each other and the second group of conductive electrodes are conducted with each other.
In some embodiments, the first control switch is disposed between any two of the first set of conductive electrodes, and the second control switch is disposed between any two of the second set of conductive electrodes.
In some embodiments, the medical device further comprises an adhesive spraying device, and the controller is further configured to activate the adhesive spraying device to spray adhesive to the conductive electrode during the cardiac treatment mode.
In some embodiments, the system further comprises an energy storage capacitor, and the controller is further configured to charge the energy storage capacitor during the cardiac treatment mode.
In some embodiments, one of the first set of conductive electrodes and the second set of conductive electrodes is disposed on a chest of the patient and the other set is disposed on a back of the patient.
In some embodiments, the first set of conductive electrodes and the second set of conductive electrodes are both disposed on the chest of the patient, and the first set of conductive electrodes and the second set of conductive electrodes are diagonally disposed.
In some embodiments, the controller is further configured to acquire motion data of the patient from the motion sensor, and determine whether a cardiac therapy mode needs to be entered based on the cardiac monitoring data and the motion data.
In some embodiments, the heart monitoring system further comprises a data communication device for transmitting the heart monitoring data to an external device, wherein the data communication device comprises a wired communication device and/or a wireless communication device.
In some embodiments, the medical device further comprises a display device connected to the controller for displaying at least one of patient information, the cardiac monitoring data, device status data, and electrode status data, and/or receiving at least one of a therapy control parameter, a device operating status control command, and an electrode operating status control command set by a user.
The embodiment of the invention also provides a control method of the wearable cardiac medical equipment, which comprises the following steps:
the controller collects cardiac monitoring data of the patient through the conductive electrode;
the controller determines whether therapy delivery is required based on the cardiac monitoring data;
the controller delivers therapy to the patient via the conductive electrodes if therapy delivery is desired.
In some embodiments, the controller acquires cardiac monitoring data of the patient via the conductive electrodes, comprising the steps of:
the controller acquires a potential value from the conductive electrode;
the controller obtains electrocardiosignals of a patient according to the potential difference between any two non-conductive electrodes, and generates the heart monitoring data according to the electrocardiosignals.
In some embodiments, the plurality of conductive electrodes includes a first set of conductive electrodes and a second set of conductive electrodes, the medical device further includes a glue-spraying device and an energy storage capacitor;
the controller delivers therapy to the patient through the conductive electrode, including the steps of:
the controller starts the glue spraying device to spray glue on the conductive electrode;
the controller charges the energy storage capacitor;
the controller controls the first group of conductive electrodes to be conducted with each other to serve as a positive electrode, and the second group of conductive electrodes to be conducted with each other to serve as a negative electrode;
the controller controls the energy storage capacitor to discharge the conductive electrode and deliver therapy to the patient through the conductive electrode.
In some embodiments, after the controller delivers therapy to the patient via the conductive electrode, the controller further comprises the steps of:
the controller controls the first group of conductive electrodes to be disconnected, and the second group of conductive electrodes to be disconnected;
the controller continues to acquire patient cardiac monitoring data via the conductive electrodes.
In some embodiments, the medical device further comprises a motion sensor;
the controller determining whether therapy delivery is required based on the cardiac monitoring data, comprising the steps of:
the controller acquiring motion data from the motion sensor;
the controller determines whether therapy delivery is required based on the cardiac monitoring data and the motion data.
An embodiment of the present invention further provides a medical system, including:
the wearable cardiac medical device, the medical device comprising a data communication means;
and the external device is used for acquiring and storing the heart monitoring data from the data communication device of the wearable heart medical device.
In some embodiments, the external device is further configured to perform analysis by using a preset dynamic analysis algorithm according to the cardiac monitoring data, obtain a dynamic analysis index, and generate a dynamic analysis report within a first time range.
In some embodiments, the external device is further configured to perform analysis by using a preset trend analysis algorithm according to the dynamic analysis indicator to obtain a trend analysis indicator, and generate a trend analysis report within a second time range, where the second time range is greater than the first time range.
In some embodiments, the external device is further configured to extract a risk assessment feature from one or more of the patient information, the cardiac monitoring data, the dynamic analysis index, and the trend analysis index, and input the risk assessment feature into a trained sudden cardiac death risk assessment model to obtain a sudden cardiac death risk assessment value.
In some embodiments, the external device is further configured to collect a plurality of training samples, construct a training sample set, add a risk assessment value label to the training samples, and train the sudden cardiac death risk assessment model based on the training sample set and the corresponding risk assessment value label.
The wearable heart medical equipment, the control method and the medical system provided by the invention have the following advantages:
according to the wearable cardiac medical equipment, the electrocardio acquisition and the defibrillation share one set of conductive electrode, so that the structure of the wearable cardiac medical equipment is simplified, the connecting points of the conducting wire and the conductive electrode are reduced, the probability of poor contact or disconnection of the connecting points is reduced, the fault rate of the medical equipment is reduced, the number of the whole electrodes can be reduced, the wearing and the use are more convenient, and the wearing comfort and the compliance of a patient are improved.
Drawings
Other features, objects and advantages of the present invention will become more apparent upon reading of the following detailed description of non-limiting embodiments thereof, with reference to the accompanying drawings.
FIG. 1 is a block diagram of a wearable cardiac medical device in accordance with an embodiment of the invention;
FIG. 2 is a schematic diagram of the connection of the conductive electrode to the controller according to one embodiment of the present invention;
FIG. 3 is a block diagram of a wearable cardiac medical device in accordance with an embodiment of the present invention;
FIG. 4 is a flow chart of a method of controlling a wearable cardiac medical device in accordance with an embodiment of the present invention;
FIG. 5 is a flow chart of a medical device delivering therapy in accordance with one embodiment of the present invention;
fig. 6 is a block diagram of a medical system according to an embodiment of the present invention.
Detailed Description
Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments may, however, be embodied in many different 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 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. In the specification, "or" may mean "and" or ". Nothing in this specification should be construed as requiring a specific three dimensional orientation of structures in order to fall within the scope of the invention. Although the description may refer to certain features as "first" or "second," etc., this is done for convenience only and is not intended to limit the number or importance of particular features.
As shown in fig. 1, the wearable cardiac medical device includes a wearable garment M100 and a device host M200. In this embodiment, the wearable cardiac medical device is taken as an example of a wearable defibrillator. Patients who generally have a higher risk of sudden cardiac death need to wear the wearable defibrillator. The wearable cardiac medical device comprises a wearable garment M100 and a device host M200. The wearable garment M100 may be, for example, a wearable vest, a harness, or the like, for placing the conductive electrodes M110 around the heart of the patient. The wearable garment M100 is internally provided with N conductive electrodes M110, N is more than or equal to 2, and the conductive electrodes M110 are attached to the body surface of a patient when in use. The device host M200 includes a housing and a controller M210 located inside the housing. The controller M210 is connected to each of the conductive electrodes M110 through a lead M300. The controller M210 includes a data acquisition unit M211, a data processing unit M212, and a treatment control unit M213. The data acquisition unit M211 is configured to acquire cardiac monitoring data of the patient through the conductive electrode M110 in a cardiac monitoring mode. The data processing unit M212 is configured to determine whether a cardiac therapy mode needs to be entered according to the cardiac monitoring data, for example, perform arrhythmia analysis according to the cardiac monitoring data, and determine that the cardiac therapy mode needs to be entered, i.e., start therapy, if VF/VT occurs. The therapy control unit M213 is used to deliver therapy to the patient through the conductive electrode M110 in the cardiac therapy mode, i.e. to defibrillate the patient. Thus, the conductive electrode M110 can be used as a cardiac monitoring electrode in a cardiac monitoring mode and as a cardiac treatment electrode in a cardiac treatment mode. According to the wearable cardiac medical equipment, the electrocardio acquisition and the defibrillation share one set of conductive electrode, so that the structure of the wearable cardiac medical equipment is simplified, the connection points of the conducting wire M300 and the conductive electrode M110 are reduced, the probability of poor contact or disconnection of the connection points is reduced, the fault rate of the medical equipment is reduced, the number of the whole electrodes can be reduced, the wearing and the use are more convenient, and the wearing comfort and the compliance of a patient are improved.
In this embodiment, as shown in FIG. 2, the plurality of conductive electrodes includes a first set of conductorsAn electrical electrode M111 and a second set of conductive electrodes M112. The first set of conductive electrodes M111 comprises N 1 A second set of conductive electrodes M112 comprising N 2 A conductive electrode, wherein N 1 ≥1，N 2 ≥1，N＝N 1 +N 2 . When the first group of conductive electrodes M111 comprises one conductive electrode and the second group of conductive electrodes M112 comprises one conductive electrode, the conductive electrodes are directly sprayed with glue and discharged when the cardiac monitoring mode is switched to the cardiac therapy mode. When the first group of conductive electrodes M111 includes at least two conductive electrodes and the second group of conductive electrodes M112 includes at least two conductive electrodes, a control switch needs to be additionally added to control on/off of the same group of conductive electrodes. In fig. 2, the first set of conductive electrodes M111 includes three conductive electrodes: conductive electrode 11, conductive electrode 12 and conductive electrode 13, the second set of conductive electrodes M12 includes three conductive electrodes: the conductive electrode 21, the conductive electrode 22, and the conductive electrode 23 will be described as an example. The controller M210 is connected to each of the conductive electrodes through a wire M300, respectively. The first group of conductive electrodes M111 has a first control switch K1 between every two conductive electrodes, and the second group of conductive electrodes M112 has a second control switch K2 between every two conductive electrodes. The controller M210 controls the first control switch K1 and the second control switch K2 according to different operation modes. When the first control switch K1 and the second control switch K2 are both off, all the conductive electrodes are not conducted with each other, and this time, the method can be used for acquiring cardiac monitoring data in the cardiac monitoring mode. When the first control switch K1 and the second control switch K2 are both closed, all the conductive electrodes 11-13 of the first group of conductive electrodes M111 are conducted with each other as positive electrodes, and all the conductive electrodes 21-23 of the second group of conductive electrodes M112 are conducted with each other as negative electrodes, so that the therapy can be delivered to the patient in the cardiac therapy mode.
Specifically, in the heart monitoring mode, the controller M210 controls the first control switch K1 and the second control switch K2 to be turned off, and the controller M210 obtains a potential value from the conductive electrodes and obtains a potential value according to the potential between any two non-conductive electrodesThe cardiac monitoring data may include, for example, the cardiac signal itself, an electrocardiogram obtained from the cardiac signal, and data such as a heart rate and a waveform of the cardiac signal calculated from the cardiac signal. Under the condition of N conductive electrodes, the number of the signal channels which can be collected is
The data processing unit M212 is used for acquiring data
The electrocardiosignals of each channel are subjected to real-time heart index analysis, and the heart indexes comprise heart rate values and the like. Specifically, the data processing unit M212 firstly pairs
And evaluating the signal quality of each channel, selecting the channel signals with better quality, namely the signal quality evaluation meets the preset quality requirement, calculating the heart rate value of the patient, and analyzing arrhythmia. The preset quality requirements may include, for example, requirements for delay time, requirements for signal jitter, etc.
In the cardiac treatment mode, the controller M210 controls the first control switches K1 to be closed, all the conductive electrodes in the first group of conductive electrodes M111 are conducted to each other to be positive, the controller M210 controls the second control switches K2 to be closed, and all the conductive electrodes in the second group of conductive electrodes M112 are conducted to each other to be negative. The controller M210 then discharges the treatment to the patient via the first set of conductive electrodes M111 and the second set of conductive electrodes M112. After the wearable garment M100 is worn on the patient, the first set of conductive electrodes M111 is disposed on the chest of the patient, and the second set of conductive electrodes M112 is disposed on the back of the patient, or the second set of conductive electrodes M112 is disposed on the chest of the patient, and the first set of conductive electrodes M111 is disposed on the back of the patient, so as to ensure that the current passes through the heart during the discharge therapy. In another embodiment, the first set of conductive electrodes M111 and the second set of conductive electrodes M112 may be disposed in front of the chest of the patient, and the first set of conductive electrodes M111 and the second set of conductive electrodes M112 are disposed diagonally, for example, one set of conductive electrodes is disposed on the upper left of the chest of the patient, and the other set of conductive electrodes is disposed on the lower right of the chest of the patient, so as to ensure that the current passes through the heart during the discharge treatment.
In other alternative embodiments, the number of the conductive electrodes in the first group of conductive electrodes M111 may be other values, for example, the first group of conductive electrodes M111 includes one, two, four, five or more conductive electrodes. The number of conductive electrodes in the second set of conductive electrodes M112 may be other values, for example, the second set of conductive electrodes M112 includes one, two, four, five or more conductive electrodes. The number of the conductive electrodes in the first group of conductive electrodes M111 and the second group of conductive electrodes M112 may be the same or different. A control switch may be disposed between the conductive electrodes in the first group of conductive electrodes M111 and the conductive electrodes in the second group of conductive electrodes M112, and the grouping of the conductive electrodes may be adjusted by turning on and off the control switch.
In this embodiment, the first control switch K1 is disposed between any two conductive electrodes in the first group of conductive electrodes M111, and the second control switch K2 is disposed between any two conductive electrodes in the second group of conductive electrodes M112. In another alternative embodiment, the number of the first control switch K1 and the second control switch K2 may be reduced, for example, in the example of fig. 2, the first control switch K1 is only arranged between the conductive electrode 11 and the conductive electrode 12 and between the conductive electrode 12 and the conductive electrode 13, and the purpose that the conductive electrode 11, the conductive electrode 12 and the conductive electrode 13 are all conducted when the first control switch K1 is closed may also be achieved, and the second control switch K2 is only arranged between the conductive electrode 21 and the conductive electrode 22 and between the conductive electrode 22 and the conductive electrode 23, and the purpose that the conductive electrode 21, the conductive electrode 22 and the conductive electrode 23 are all conducted when the second control switch K2 is closed may also be achieved.
In another alternative embodiment, it is not necessary that all of the conductive electrodes be disconnected during the electrocardiographic monitoring mode. For example, in the example of fig. 2, in the electrocardiographic monitoring mode, the conductive electrode 11 and the conductive electrode 12 are still kept conductive, while the other conductive electrodes are disconnected from each other, the potential difference between the conductive electrode 11 and the conductive electrode 12 is 0, which is not used as the electrocardiographic signal, and the potential difference between any other two non-conductive electrodes is used as the electrocardiographic signal of the patient.
Fig. 3 is a block diagram of a wearable cardiac medical device according to a specific example. In this specific example, a motion sensor M120 is further disposed in the wearable garment M100, and the motion sensor M120 may include, for example, a gyroscope, a vibration sensor, a speed sensor, an acceleration sensor, and the like, and is used for detecting a motion state of the patient. The data acquisition unit M211 is further configured to acquire motion data from the motion sensor 120, and the data processing unit M212, when determining whether to enter the cardiac therapy mode, determines the motion state of the patient according to the motion data, that is, comprehensively determines whether to enter the cardiac therapy mode according to the cardiac monitoring data and the motion data, so as to reduce the occurrence rate of false alarm and false defibrillation of the shockable heart rate (VF/VT) of the patient in the motion state.
As shown in fig. 3, the apparatus main unit M200 further includes a display device M220, a glue spraying device M230, a storage device M240, an alarm device M250, a response button M260, and a data communication device M270 respectively connected to the controller M210. The device host M200 is further provided with a battery M280 for supplying power to each component in the device host M200. The display device M220 may be disposed on a side surface of the housing, and is used for information interaction between the apparatus main unit M200 and a patient and a doctor. Specifically, the display device M220 is configured to display at least one of patient information, the cardiac monitoring data, device status data, and electrode status data, and/or receive at least one of a therapy control parameter, a device operating status control command, and an electrode operating status control command set by a user. The patient information includes, for example, the name, age, illness, etc. of the patient. The cardiac monitoring data includes, for example, an electrocardiographic waveform, a heart rate value, and the like. The device status data includes, for example, the current operating state of the device, therapy control parameters, and the like. The device operating state includes, for example, device standby, device shutdown, device start-up therapy, etc. The electrode operation state includes, for example, electrode on, electrode off, and the like. The electrode state data includes, for example, whether the electrode is detached, whether the electrode is failed, the operating state of the electrode, and the like. The therapy control parameters include, for example, a heart rate threshold at which the heart rate may be shockable and the amount of energy delivered for defibrillation. For example, the display device M220 displays information of the patient, the electrocardiographic waveform being collected, the heart rate value, information on whether the lead is detached, and the like. The physician may also program the heart rate threshold at which the heart rate may be shockable and the amount of energy delivered for defibrillation via the display device M220. The display device M220 may be a touch screen. Alternatively, the display device M220 may be a touch-incapable display screen. An input keyboard is additionally arranged for the user to set treatment control parameters and the like.
The glue spraying device M230 at least comprises a device for storing conductive silica gel and a device for spraying the conductive silica gel onto the surface of the conductive electrode. The controller M210 may be implemented by a control chip plus a control circuit. The treatment control unit M213 at least comprises a treatment control circuit, a glue spraying control switch, an energy storage capacitor, a charging control switch and a discharging control switch. Taking cardiac therapy as an example of defibrillation therapy, when the data processing unit M212 determines that a cardiac therapy mode needs to be entered, that is, when therapy needs to be started, the therapy control circuit first controls the glue spraying control switch to be turned on, so that the glue spraying device M230 sprays conductive silica gel on the surface of the conductive electrode. Then, the therapy control circuit controls the charging control switch to be turned on, and the energy storage capacitor is charged through the battery M280. After the charging is finished, the treatment control circuit controls the first control switch and the second control switch to be closed, controls the discharge control switch to be conducted, and discharges to the patient for treatment through the first group of conductive electrodes and the second group of conductive electrodes.
The storage device M240 is configured to store the cardiac monitoring data acquired by the data acquisition unit M211. The alarm means M250 is adapted to initiate an alarm when the data processing unit M212 determines that the cardiac therapy mode needs to be entered. The alarm device M250 may include one or more of an alarm indicator, a buzzer, a speaker, and a vibrator disposed on the housing, for example. When the data processing device M212 determines that therapy delivery is required, an alarm sequence is initiated to trigger one or more of a light, vibration, or voice alarm to prompt the patient or peripheral personnel that defibrillation is about to be initiated. The glue spray, charging and discharging can then continue to be initiated.
The response button M260 is provided on the outer surface of the housing to confirm whether the patient is conscious. Preferably, the response buttons M260 are provided on both front and rear side surfaces of the housing, preventing a mis-touch in which only one response button M260 is provided. When the data processing unit M211 determines that the cardiac treatment mode needs to be entered, if the patient and/or others press the response buttons M260 on both the front and back side surfaces simultaneously, it is confirmed that the patient is conscious, the treatment is not started, or the treatment procedure is terminated/delayed. The data communication device M270 may be a wireless communication device or a wired communication device, and may transmit the heart monitoring data acquired by the data acquisition unit M211 in real time to an external device, may transmit the historical heart monitoring data stored in the storage device M250 to the external device, and may transmit data such as the operating state, the operating mode, and the operating state of the conductive electrode M110 of the device host M200 to the external device. For example, the electrocardiographic monitoring data collected in real time is transmitted to an external device, such as a remote server, via the wireless communication device, and the data in the storage device M240 is exported to the external device via a wired or wireless communication device. The wireless communication device includes, but is not limited to, 3G, 4G, 5G, bluetooth, etc. The wired communication means includes, but is not limited to, communicating with an external device using a USB interface. The external device includes, but is not limited to, a mobile terminal used by a user, such as a mobile phone, a notebook, a desktop, a tablet computer, etc., or a remote server, etc.
As shown in fig. 4, an embodiment of the present invention further provides a method for controlling a wearable cardiac medical device, where the method includes the following steps:
s100: the controller acquires cardiac monitoring data of the patient through the conductive electrode, and the medical equipment is in a cardiac monitoring mode at the moment;
s200: the controller determines whether therapy delivery is required based on the cardiac monitoring data;
s300: if therapy delivery is desired, the controller delivers therapy to the patient via the conductive electrodes while the medical device is in a cardiac therapy mode.
Therefore, in the control method of the invention, the heart monitoring data is acquired by the conductive electrode in the step S100, and the therapy is delivered by the conductive electrode in the step S300, i.e. the electrocardiogram acquisition and the defibrillation share one set of conductive electrode, so that the structure of the wearable heart medical equipment is simplified, the failure rate of the medical equipment is reduced, the number of the whole electrodes can be reduced, the wearing and the use are more convenient, and the wearing comfort and the compliance of the patient are improved.
In this embodiment, the step S100: the controller collects cardiac monitoring data of a patient via the conductive electrodes, comprising the steps of:
the controller acquires a potential value from the conductive electrode;
the controller obtains an electrocardiosignal of a patient according to the potential difference between any two non-conductive electrodes, and generates the heart monitoring data according to the electrocardiosignal, wherein the heart monitoring data can comprise the electrocardiosignal itself, an electrocardiogram obtained from the electrocardiosignal, and data such as a heart rate and an electrocardiosignal waveform obtained by calculating the electrocardiosignal.
Under the condition of N conductive electrodes, the number of the signal channels which can be collected is
The controller is based on the collected
The electrocardiosignals of each channel are analyzed in real time, and firstly, the electrocardiosignals of each channel are analyzed
And evaluating the signal quality of each channel, selecting the signal of the channel with better quality according to the signal quality evaluation result, calculating the heart rate value of the patient, and analyzing arrhythmia.
In this embodiment, the plurality of conductive electrodes includes N 1 A first group of conductive electrodes and N 2 A second group of conductive electrodes, N 1 +N 2 N, and N 1 And N 2 Preferably 2 or more, but the present invention is not limited thereto. The medical equipment also comprises a glue spraying device and an energy storage capacitor, and can further comprise a corresponding glue spraying control switch, a charging control switch and a discharging control switch.
As shown in fig. 5, the step S300: a controller delivers therapy to the patient through the conductive electrode, comprising the steps of:
s310: the controller starts the glue spraying device to spray glue on the conductive electrode, for example, the glue spraying device sprays conductive silica gel on the surface of the conductive electrode by switching on the glue spraying control switch;
s320: the controller charges the energy storage capacitor, for example, by turning on the charge control switch, a battery is controlled to charge the energy storage capacitor;
s330: the controller controls the first group of conductive electrodes to be conducted with each other to serve as a positive electrode, and the second group of conductive electrodes to be conducted with each other to serve as a negative electrode, for example, the first group of conductive electrodes are conducted with each other by controlling the first control switch to be conducted, and the second group of conductive electrodes are conducted with each other by controlling the second control switch to be conducted;
s340: the controller controls the energy storage capacitor to discharge the conductive electrodes to deliver therapy to the patient through the conductive electrodes, for example, by turning on the discharge control switch to discharge defibrillation to the patient through the first set of conductive electrodes and the second set of conductive electrodes.
In this embodiment, the step S300: after the controller delivers therapy to the patient via the conductive electrode, the method further comprises the steps of:
the controller controls the first group of conducting electrodes to be disconnected, and the second group of conducting electrodes to be disconnected, for example, controls the first control switch and the second control switch to be disconnected;
the controller continues to acquire patient cardiac monitoring data via the conductive electrodes and automatically terminates the therapy program when cardiac monitoring data is detected to return to normal, e.g., the heart rhythm automatically returns to a non-shockable rhythm.
Therefore, in this embodiment, only in the cardiac therapy mode, the first set of conductive electrodes are conducted and the second set of conductive electrodes are conducted, so that only cardiac therapy, such as defibrillation, can be performed, and acquisition of electrocardiographic monitoring data cannot be performed. Before the heart treatment mode is started and after the heart treatment mode is completed, the heart monitoring mode is restored again, namely all the conductive electrodes are not conducted.
In this embodiment, the medical device further comprises a motion sensor. The step S200: the controller determines from the cardiac monitoring data whether delivery of therapy is required, including the steps of:
the controller acquires motion data from the motion sensor, the motion data can be synchronously acquired with the electrocardio monitoring data, and the controller can determine the current motion state of the patient according to the motion data;
the controller comprehensively judges whether therapy needs to be delivered or not according to the heart monitoring data and the motion data, and reduces the false alarm and false defibrillation incidence rate of the shockable heart rate (VF/VT) of the patient in the motion state.
In traditional wearable external automatic defibrillator, wear and gather electrocardio data at the patient after, carry out real-time arrhythmia analysis, when detecting the rhythm of the heart that can shock, carry out the treatment of defibrillating of discharging, but the heart monitoring data of gathering does not save at the equipment host computer, also does not transmit heart monitoring data to the outside through wireless communication mode and saves. After the wearing machine is finished, the acquired dynamic electrocardiogram data cannot be analyzed secondarily, and the arrhythmia condition of the patient is not analyzed and counted, so that a large amount of information related to sudden cardiac death of the patient, such as the heart rate, arrhythmia, heart rate variability and the like, is lost, and particularly for patients who have high risk of sudden cardiac death and need 3-6 months long periods and continuously wear medical equipment. Therefore, in the invention, furthermore, analysis and statistics of heart monitoring data can be carried out through an external device, an analysis report is provided for a patient, the patient is informed of the heart state, and the sudden cardiac death risk can be evaluated. The external device includes, but is not limited to, a mobile terminal used by a user, such as a mobile phone, a notebook, a desktop, a tablet computer, or the like, or a remote server, or the like. The operation of the external device will be described in detail with reference to fig. 6.
As shown in fig. 6, the embodiment of the present invention further provides a medical system, which includes the wearable cardiac medical device M10 and the external device M40. The medical apparatus M10 includes at least a data communicator M270. The external device M40 is used to acquire and store cardiac monitoring data from the data communicator M270 of the wearable cardiac medical device M10. The data communication device M270 may be a wireless communication device, and may communicate with the external device M40 by using a 3G, 4G, 5G, bluetooth, or the like, or may be a wired communication device, and may communicate with the external device M40 by using a USB, or the like, but the present invention is not limited thereto.
In this embodiment, the external device M40 includes a data storage module M410 for storing cardiac monitoring data acquired from the medical device M10, as well as self-generated data, reports, models, and the like. The external device M40 further includes a dynamic analysis module M420, configured to perform analysis by using a preset dynamic analysis algorithm, for example, Holter dynamic electrocardiographic analysis, according to the heart monitoring data, to obtain a dynamic analysis index, and generate a dynamic analysis report in a first time range. Holter refers to a dynamic electrocardiogram, which is the whole process of continuously recording the electrocardio-activity of a patient for 24 hours or more in a daily life state, and is analyzed and processed by a computer to find arrhythmia, myocardial ischemia and the like which are not easy to be found in routine electrocardiogram examination, thereby providing an important objective basis for clinical diagnosis, treatment and curative effect judgment. The dynamic analysis indicator may include information such as heart rate, arrhythmia state, heart rate variability, and the like, for example. The first time range may be, for example, 1 day, 3 days, 5 days, etc.
In this embodiment, the external device M40 further includes a trend analysis module M430, configured to perform analysis by using a preset trend analysis algorithm according to the dynamic analysis indicator, obtain a trend analysis indicator, and generate a trend analysis report in a second time range, where the second time range is greater than the first time range. The second time frame may be, for example, one week, one month, three months, etc. The trend analysis report can be provided to a doctor, and the doctor refers to the trend analysis report to guide and adjust the arrhythmia clinical medication. The trend analysis index may be, for example, a rate of change in heart rate, a frequency of occurrence of arrhythmia, or the like. The trend analysis report can represent the variation trend in the form of a graph, a line graph and the like.
In this embodiment, the external device M40 further includes a risk assessment module M440, where the risk assessment module M440 is pre-stored with a trained sudden cardiac death risk assessment model, and is further configured to extract a risk assessment feature according to one or more of the patient information, the cardiac monitoring data, the dynamic analysis index, and the trend analysis index, and input the risk assessment feature into the trained sudden cardiac death risk assessment model to obtain a sudden cardiac death risk assessment value. The risk assessment feature includes attribute values corresponding to a plurality of attributes, for example, including a mean value of heart rate over a certain period of time, an occurrence frequency of arrhythmia, an occurrence trend of arrhythmia, etc., and may include basic information of the patient, such as age, sex, etc., of the patient. The sudden cardiac death risk assessment model can adopt a machine learning model, such as a deep learning model, a support vector machine, a decision tree and the like. The input of the sudden cardiac death risk assessment model is a risk assessment characteristic, and the output of the sudden cardiac death risk assessment model is a sudden cardiac death risk assessment value, namely the risk of sudden cardiac death. By the sudden cardiac death risk assessment value, a doctor, a patient or family members thereof can be assisted to decide whether to continue wearing the wearable cardiac medical device or not, whether to upgrade the wearable cardiac medical device to an Implantable cardiac medical device, such as an ICD (Implantable cardiac defibrillator) or the like. For example, a first risk threshold and a second risk threshold are set, the first risk threshold is larger than the second risk threshold, if the sudden cardiac death risk assessment value is larger than the first risk threshold, the wearable cardiac medical device needs to be upgraded to the implantable cardiac medical device, if the sudden cardiac death risk assessment value is between the first risk threshold and the second risk threshold, the wearable cardiac medical device needs to be worn continuously, and if the sudden cardiac death risk assessment value is smaller than the first risk threshold, the wearable cardiac medical device does not need to be worn continuously.
In this embodiment, the external device is further configured to collect a plurality of training samples, construct a training sample set, add a risk assessment value label to the training samples, and train the sudden cardiac death risk assessment model based on the training sample set and the corresponding risk assessment value label. The training samples may be derived from one or more of outpatient data, a hospital database, derived data of a wearable cardiac medical device, derived data of an implantable medical device. And (3) collating the data in the training sample to obtain a risk assessment characteristic corresponding to each patient, and labeling the patient by whether sudden cardiac death occurs or not, wherein if the sudden cardiac death occurs, the patient is labeled as 1, and if the sudden cardiac death does not occur, the patient is labeled as 0, so that a positive sample and a negative sample are formed. And then, carrying out iterative training on the sudden cardiac death risk assessment model by adopting positive and negative samples, calculating a loss function value according to the output of the sudden cardiac death risk assessment model and a corresponding risk assessment value label, and stopping training until the loss function value is smaller than a preset loss threshold value through iterative training to obtain the trained sudden cardiac death risk assessment model.
The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and it is not intended that the invention be limited to these specific details. For those skilled in the art to which the invention pertains, several simple deductions or substitutions can be made without departing from the spirit of the invention, and all shall be considered as belonging to the protection scope of the invention.
Claims (23)
1. A wearable cardiac medical device, comprising:
a plurality of conductive electrodes;
the controller is connected with the plurality of conductive electrodes and used for collecting heart monitoring data of the patient through the conductive electrodes in a heart monitoring mode, judging whether the heart treatment mode needs to be entered or not according to the heart monitoring data and delivering treatment to the patient through the conductive electrodes in the heart treatment mode.
2. The wearable cardiac medical device of claim 1, wherein in a cardiac monitoring mode the controller is configured to obtain a potential value from the conductive electrodes and obtain an electrical cardiac signal of the patient based on a potential difference between any two non-conductive electrodes, and generate the cardiac monitoring data based on the electrical cardiac signal.
3. The wearable cardiac medical device of claim 2, comprising N conductive electrodes, the controller generating the cardiac monitoring data from the cardiac electrical signals, including pairs
And performing signal quality evaluation on the electrocardiosignals of the signal channels, selecting the electrocardiosignals of which the signal quality evaluation meets the preset quality requirement, performing heart index analysis, and generating the heart monitoring data.
4. The wearable cardiac medical device of claim 1, wherein the plurality of conductive electrodes comprises a first set of conductive electrodes comprising at least one conductive electrode and a second set of conductive electrodes comprising at least one conductive electrode;
in the cardiac treatment mode, the controller controls all the conductive electrodes in the first group of conductive electrodes to be conducted with each other to be used as positive electrodes, controls all the conductive electrodes in the second group of conductive electrodes to be conducted with each other to be used as negative electrodes, and discharges and treats the patient through the first group of conductive electrodes and the second group of conductive electrodes.
5. The wearable cardiac medical device of claim 4, wherein the first set of conductive electrodes has at least one first control switch disposed therein and the second set of conductive electrodes has at least one second control switch disposed therein;
the controller is used for controlling the first control switch and the second control switch to be switched off in an electrocardio monitoring mode so that all the conductive electrodes are not conducted, and controlling the first control switch and the second control switch to be switched on in a heart treatment mode so that the first group of conductive electrodes are conducted with each other and the second group of conductive electrodes are conducted with each other.
6. The wearable cardiac medical device of claim 5, wherein the first control switch is disposed between any two of the first set of conductive electrodes and the second control switch is disposed between any two of the second set of conductive electrodes.
7. The wearable cardiac medical device of claim 1, further comprising an adhesive dispensing device, wherein the controller is further configured to activate the adhesive dispensing device to dispense adhesive to the conductive electrode during a cardiac treatment mode.
8. The wearable cardiac medical device of claim 1, further comprising an energy storage capacitor, the controller further configured to charge the energy storage capacitor during a cardiac treatment mode.
9. The wearable cardiac medical device of claim 4, wherein one of the first set of conductive electrodes and the second set of conductive electrodes is disposed on a chest of the patient and the other set is disposed on a back of the patient.
10. The wearable cardiac medical device of claim 4, wherein the first and second sets of conductive electrodes are each disposed on a chest of a patient, and wherein the first and second sets of conductive electrodes are diagonally disposed.
11. The wearable cardiac medical device of claim 1, further comprising a motion sensor, wherein the controller is further configured to obtain motion data of the patient from the motion sensor, and determine whether a cardiac therapy mode needs to be entered based on the cardiac monitoring data and the motion data.
12. The wearable cardiac medical device of claim 1, further comprising a data communication means for transmitting the cardiac monitoring data to an external device, the data communication means comprising a wired communication means and/or a wireless communication means.
13. The wearable cardiac medical device of claim 1, further comprising a display device coupled to the controller for displaying at least one of patient information, the cardiac monitoring data, device status data, and electrode status data, and/or receiving at least one of a user-set therapy control parameter, a device operating status control command, and an electrode operating status control command.
14. A method of controlling a wearable cardiac medical device, wherein the wearable cardiac medical device of any one of claims 1 to 13 is used, the method comprising the steps of:
the controller collects cardiac monitoring data of the patient through the conductive electrode;
the controller determines whether therapy delivery is required based on the cardiac monitoring data;
the controller delivers therapy to the patient via the conductive electrodes if therapy delivery is desired.
15. The method for controlling a wearable cardiac medical device according to claim 14, wherein the controller acquires cardiac monitoring data of the patient via the conductive electrode, comprising the steps of:
the controller acquires a potential value from the conductive electrode;
the controller obtains electrocardiosignals of a patient according to the potential difference between any two non-conductive electrodes, and generates the heart monitoring data according to the electrocardiosignals.
16. The method of claim 14, wherein the plurality of conductive electrodes comprises a first set of conductive electrodes and a second set of conductive electrodes, the medical device further comprising a glue dispensing device and an energy storage capacitor;
the controller delivers therapy to the patient through the conductive electrode, including the steps of:
the controller starts the glue spraying device to spray glue on the conductive electrode;
the controller charges the energy storage capacitor;
the controller controls the first group of conductive electrodes to be conducted with each other to serve as a positive electrode, and the second group of conductive electrodes to be conducted with each other to serve as a negative electrode;
the controller controls the energy storage capacitor to discharge the conductive electrode and deliver therapy to the patient through the conductive electrode.
17. The method of controlling a wearable cardiac medical device of claim 16, wherein after the controller delivers therapy to the patient via the conductive electrode, further comprising the steps of:
the controller controls the first group of conductive electrodes to be disconnected, and the second group of conductive electrodes to be disconnected;
the controller continues to acquire patient cardiac monitoring data via the conductive electrodes.
18. The method of controlling a wearable cardiac medical device of claim 14, wherein the medical device further comprises a motion sensor;
the controller determining whether therapy delivery is required based on the cardiac monitoring data, comprising the steps of:
the controller acquiring motion data from the motion sensor;
the controller determines whether therapy delivery is required based on the cardiac monitoring data and the motion data.
19. A medical system, comprising:
the wearable cardiac medical device of any of claims 1-13, the medical device comprising a data communication means;
and the external device is used for acquiring and storing the heart monitoring data from the data communication device of the wearable heart medical device.
20. The medical system of claim 19, wherein the external device is further configured to perform an analysis using a predetermined dynamic analysis algorithm based on the cardiac monitoring data to obtain a dynamic analysis index, and generate a dynamic analysis report within a first time range.
21. The medical system of claim 20, wherein the external device is further configured to perform an analysis using a predetermined trend analysis algorithm according to the dynamic analysis indicator to obtain a trend analysis indicator, and generate a trend analysis report within a second time range, wherein the second time range is greater than the first time range.
22. The medical system of claim 21, wherein the external device is further configured to extract a risk assessment feature from one or more of patient information, the cardiac monitoring data, the dynamic analysis index, and the trend analysis index, and input the risk assessment feature into a trained sudden cardiac death risk assessment model to obtain a sudden cardiac death risk assessment value.
23. The medical system of claim 22, wherein the external device is further configured to collect a plurality of training samples, construct a training sample set, add a risk assessment value label to the training samples, and train the sudden cardiac death risk assessment model based on the training sample set and the corresponding risk assessment value label.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210389370.3A CN114870259A (en) | 2022-04-13 | 2022-04-13 | Wearable cardiac medical equipment, control method and medical system |
| PCT/CN2022/095754 WO2023197420A1 (en) | 2022-04-13 | 2022-05-27 | Wearable cardiac medical device, control method and medical system |
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| CN202210389370.3A CN114870259A (en) | 2022-04-13 | 2022-04-13 | Wearable cardiac medical equipment, control method and medical system |
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|---|---|---|---|---|
| CN116271540A (en) * | 2023-05-19 | 2023-06-23 | 苏州维伟思医疗科技有限公司 | Cardiac rhythm management system and method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN204306822U (en) * | 2014-12-09 | 2015-05-06 | 电子科技大学 | Wearable electrocardiosignal monitoring device |
| US11213691B2 (en) * | 2017-02-27 | 2022-01-04 | Zoll Medical Corporation | Ambulatory medical device interaction |
| US11364387B2 (en) * | 2017-07-28 | 2022-06-21 | West Affum Holdings Corp. | Heart rate calculator with reduced overcounting |
| CN109908479A (en) * | 2017-12-13 | 2019-06-21 | 裴嘉豪 | A kind of implantable medical control system |
| CN209596412U (en) * | 2018-07-13 | 2019-11-08 | 久心医疗科技（苏州）有限公司 | A kind of external defibrillation device |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116271540A (en) * | 2023-05-19 | 2023-06-23 | 苏州维伟思医疗科技有限公司 | Cardiac rhythm management system and method |
| CN116271540B (en) * | 2023-05-19 | 2023-08-04 | 苏州维伟思医疗科技有限公司 | Cardiac rhythm management system and method |
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