CN112022107A - Combined device for external cardioversion and defibrillation - Google Patents

Combined device for external cardioversion and defibrillation Download PDF

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Publication number
CN112022107A
CN112022107A CN202011065851.6A CN202011065851A CN112022107A CN 112022107 A CN112022107 A CN 112022107A CN 202011065851 A CN202011065851 A CN 202011065851A CN 112022107 A CN112022107 A CN 112022107A
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China
Prior art keywords
defibrillation
medical device
patient
cardioversion
combination
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CN202011065851.6A
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Chinese (zh)
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平利川
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Suzhou Wushuang Medical Equipment Co ltd
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Suzhou Wushuang Medical Equipment Co ltd
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Priority to CN202011065851.6A priority Critical patent/CN112022107A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3904External heart defibrillators [EHD]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/0404Electrodes for external use
    • A61N1/0408Use-related aspects
    • A61N1/046Specially adapted for shock therapy, e.g. defibrillation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3918Heart defibrillators characterised by shock pathway, e.g. by electrode configuration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3968Constructional arrangements, e.g. casings
    • GPHYSICS
    • G08SIGNALLING
    • G08BSIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B21/00Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
    • G08B21/18Status alarms
    • G08B21/182Level alarms, e.g. alarms responsive to variables exceeding a threshold
    • GPHYSICS
    • G08SIGNALLING
    • G08BSIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B7/00Signalling systems according to more than one of groups G08B3/00 - G08B6/00; Personal calling systems according to more than one of groups G08B3/00 - G08B6/00
    • G08B7/06Signalling systems according to more than one of groups G08B3/00 - G08B6/00; Personal calling systems according to more than one of groups G08B3/00 - G08B6/00 using electric transmission, e.g. involving audible and visible signalling through the use of sound and light sources

Abstract

The invention discloses an external cardioversion and defibrillation combined device which comprises a medical device and a remote analysis device. The system comprises a sensing module, a processor and a communication module; the remote analysis device includes a processor and a communication module. The medical equipment is worn by a patient and is configured to sense cardiac parameter information such as Electrocardiogram (ECG) signals of the patient through a sensing module, the cardiac parameter information is transmitted to remote analysis equipment through a communication module of the medical equipment, a processor of the remote analysis equipment analyzes and identifies whether a malignant arrhythmia event occurs or not according to the cardiac parameter information and returns an analysis and identification result, when the malignant arrhythmia event occurs, the remote analysis equipment sends a treatment command to the medical equipment, and the medical equipment carries out electric shock treatment after receiving the treatment command.

Description

Combined device for external cardioversion and defibrillation
Technical Field
The present invention relates to an external cardioversion defibrillation combination device, and more particularly, to a wearable cardioversion defibrillation combination device for monitoring and treating malignant arrhythmia events.
Background
When a person suffers from some type of arrhythmia, the result may be a reduction in blood flow to various parts of the body. Some patients may even experience cardiac arrest (SCA) due to arrhythmia. SCA can quickly lead to death, for example within 10 minutes, unless temporary treatment is performed.
Some people have an increased risk of SCA, and people at higher risk of SCA include patients with heart attacks or with previous SCA attacks. These people are often recommended to receive an Implantable Cardioverter Defibrillator (ICD). ICDs are surgically implanted in the chest cavity and continuously monitor the patient for cardiac parameter information, such as electrocardiogram signals (ECG). If certain types of arrhythmias are detected, the ICD delivers a shock through the heart.
These people are sometimes provided with an external cardioversion defibrillation device (wearable cardioversion defibrillation device) before being determined to have an increased risk of SCA and before accepting implantation of an ICD. Extracorporeal cardioversion defibrillation devices typically include a harness, vest, or other garment to be worn by the patient. The external cardioversion-defibrillation combination also includes electronic components, such as external electrodes and a controller, connected to a harness, vest, or other garment. When the patient wears the external cardioversion defibrillation combo device, the external electrodes can make good electrical contact with the patient's skin, thus helping to detect the patient's electrocardiogram. If a shockable arrhythmia is detected, the defibrillator will shock the patient's body appropriately so that the shock vector passes through the heart.
There are some patients in the clinic who are at risk of sudden cardiac death but who have short-term indications for implantable cardioverter defibrillators, or who have indications but short-term failure to newly install or replace an ICD. As a further precaution, people who have been determined to have an increased risk of SCA are sometimes given an external cardioversion defibrillation device to wear until their ICD is implanted. When the patient wears the external cardioversion defibrillation combo device, the electrodes may make good electrical contact with the patient's skin, and thus may help sense the patient's electrocardiogram signal (ECG). If a shockable arrhythmia is detected from an electrocardiogram signal (ECG) and, therefore, an appropriate shock is delivered through the heart. This can restart the patient's heart, saving their lives.
Because the external cardioversion and defibrillation combined equipment does not necessarily completely match the body shape of a patient and the equipment shell is hard, more interference factors exist in the process of sensing electrocardiogram signals (ECG), and accurate sensing and analysis of heart parameter data such as the electrocardiogram signals (ECG) become difficult. The existing Wearable Cardioverter Defibrillator (WCD) has more interference factors in the process of autonomously finishing electrocardiogram signal (ECG) sensing, analysis and defibrillation treatment.
Disclosure of Invention
The invention provides an external cardioversion defibrillation device which comprises a medical device and a remote analysis device, wherein the medical device is wearable by a patient, the medical device is transmitted to the remote analysis device after sensing electrocardiogram signals (ECG), and the remote analysis device is used for analyzing and processing data.
The invention discloses an external cardioversion and defibrillation combination device, which comprises: medical devices and remote analysis devices.
The medical device is worn by a patient to hold the electrode on the patient, and comprises a sensing module, a processor and a communication module; the remote analysis device comprises a processor and a communication module.
The medical device is configured to sense an electrocardiogram signal (ECG) of a patient through a sensing module of the medical device, a communication module of the medical device transmits the ECG signal (ECG) to the remote analysis device, a processor of the remote analysis device judges whether a malignant arrhythmia event occurs or not according to the ECG signal (ECG) and returns an analysis and identification result, when the malignant arrhythmia event occurs, the communication module of the remote analysis device sends a treatment command to the medical device, and the medical device performs shock defibrillation treatment after receiving the treatment command.
In the combined external cardioversion and defibrillation apparatus, since sensing of a cardiac parameter such as an Electrocardiogram (ECG) signal is performed outside the body through the skin, body tissues and bones, and monitoring of a specific cardiac parameter is affected by noise, temperature, obesity, and the state of contact between an electrode and the skin of a patient, the measured cardiac parameter has a certain error from actual data. To reduce such errors, the electrodes should be as close to the patient's skin as possible; meanwhile, a plurality of pairs of sensing electrodes can be arranged in the medical equipment worn by the patient, so that the sensing accuracy is enhanced, and the sensing error is reduced.
The medical device of the invention comprises a set of one or more pairs of electrodes; the set of electrodes is placed on a medical device, is capable of electrically engaging the patient's skin when worn by the patient, and is capable of sensing cardiac parameter information from the patient.
The set of electrodes includes: a set of at least one pair of electrodes for sensing a patient cardiac parameter electrocardiogram signal (ECG); a set of at least one pair of electrodes for delivering pulses to complete the shock therapy.
The medical equipment and the remote analysis equipment transmit the heart parameter information through the communication module, and if the communication module is not connected smoothly or is disconnected, the information exchange between the medical equipment and the remote analysis equipment is not timely or interrupted, so that the work of the external cardioversion defibrillation combination equipment has errors or faults. To avoid this situation, an alarm module may be provided on the external cardioversion-defibrillation combination.
The external cardioversion-defibrillation combination further comprises: an alert module coupled to the controller for providing an alert when activated by the controller, wherein the alert includes at least one or more of an audible, tactile, or visual alert; and a user interface coupled to the controller to receive a response from the patient.
The external cardioversion-defibrillation combination further comprises: one or more sensors configured to sense a plurality of events, the events comprising: electrocardiogram signals (ECG), heart sounds, blood flow, blood pressure, blood glucose, etc., and returns a sensing result according to the sensing event.
The external cardioversion-defibrillation combination further comprises: a processor configured to: prioritizing each of the plurality of events based on an analysis of a severity of each of the plurality of events and a timeliness of required remedial action, and issuing an alert corresponding to a highest priority condition of the plurality of conditions. The processor may not only issue the highest priority alarm, but also suppress lower priority alarms until the highest priority alarm has been remedied.
The alarms are respectively set according to the priority of the event, so that the priority conditions of the event can be distinguished according to the alarms with different degrees. The priority of the event is divided into a first priority, a second priority, a third priority, a fourth priority and the like, and the actual classification level of the priority can be adjusted and set according to specific actual conditions. For example, an alarm for a priority event is set to sound 5 consecutive times, and the occurrence of the whistling sound repeats 3 times, each time with 3 seconds intervals; setting the alarms with the second priority level to continuously sound 4 times; alarms of equal priority are set to whistle 3 times in succession, and so on. Alarms of different priorities may also be set to different colored light flashes or a combination of light flashes and alarm sounds.
The medical device of the present invention comprises: external defibrillation monitors, automatic external defibrillators, or semi-automatic external defibrillators.
In clinical practice, in order to reduce the diagnosis error, doctors need to observe the specific physiological parameters of patients and make judgments according to the observation results. In order to facilitate the observation of the physiological parameters of the patient by the doctor, a user display interface is required to be set, and the heart parameter data is displayed to the user display interface in a digital or image mode. The user display interface may be provided on a remote analysis device; a remote program controller can be added to the external cardioversion and defibrillation combination device and arranged on the remote program controller.
The remote analysis equipment is provided with a user interface, and the physiological parameters of the patient can be indirectly regulated and controlled by setting parameters on the user interface; the processor of the remote analysis device is configured to convert current patient cardiac parameter information into a number or image and is further configured to display the number or image to a user interface.
The external cardioversion and defibrillation combination equipment further comprises a remote controller, wherein the remote controller is provided with a communication module, a processor and a user display interface; the processor of the remote control is configured to convert the cardiac parameter information obtained from the communication module into a number or image and to display the number or image to a user interface.
The remote control apparatus includes: program control appearance, long-range follow-up visit appearance, interface display appearance or other can receive and the instrument of transmission data through the high in the clouds.
The processor of the medical device is configured to first detect a communication status between the medical device and a remote analysis device after activating a communication module of the medical device, the medical device autonomously completing analysis and identification of a malignant cardiac rhythm event when the medical device and the remote analysis device are poorly communicating or the signal is interrupted.
The processor of the remote analysis device is configured to determine whether a malignant cardiac rhythm event has occurred based on the analysis and recognition results, and to transmit the recognition results to a medical device.
The processor of the medical device is configured to determine whether to start a therapy module for defibrillation therapy according to the identified result.
The combined external cardioversion and defibrillation device of the invention divides the analysis processing of cardiac parameters such as electrocardiogram signals (ECG) and the like into independent remote analysis devices.
The medical equipment also comprises a storage module and a memory module, wherein the storage module is used for storing the heart parameter data directly sensed by the sensing module and storing heart parameter messages such as electrocardiogram signals (ECG) and the like transmitted by the medical equipment, the remote analysis equipment and the remote controller through the communication module; the memory module has a memory function for the memory module for a certain period of time, for example, from the current time to the previous 60 minutes.
The combined extracorporeal cardioversion and defibrillation device of the present invention analyzes sensed cardiac parameters, such as Electrocardiogram (ECG), on a remote analysis device. The analysis of cardiac parameter signals by the present invention is less disturbed by factors than in a WCD, reducing analysis errors. The medical equipment worn by the patient only senses the heart parameter signals, and does not need to analyze and process data like a WCD (WCD), so that the workload of the medical equipment attached to the patient is reduced, and the sensing accuracy is improved. The sensing accuracy is enhanced and redundancy of sensing and treatment signals is reduced by arranging a plurality of pairs of sensing electrodes in the medical equipment worn by the patient.
Drawings
Fig. 1 is a schematic front perspective image structure of a medical device in a patient-worn external cardioversion-defibrillation combination device;
FIG. 2 is a schematic diagram of a perspective back view of a medical device in a patient-worn external cardioversion-defibrillation combination device;
fig. 3 is a schematic diagram illustrating a first method for sharing or synchronizing data of a patient wearing a medical device via a cloud;
fig. 4 is a schematic diagram illustrating a second method for sharing or synchronizing data of a patient wearing a medical device via a cloud;
FIG. 5 is a schematic perspective view of an extracorporeal cardioversion-defibrillation combination apparatus;
fig. 6 is a flow chart of a working method of the external cardioversion-defibrillation combination device.
Detailed Description
The invention discloses an external cardioversion defibrillation device, and fig. 5 is a perspective image structure schematic diagram of the external cardioversion defibrillation combination device. The combined extracorporeal cardioversion-defibrillation apparatus comprises two parts, a medical device 500 and a remote analysis device 408. The combined external cardioversion and defibrillation device divides the analysis processing of cardiac parameters such as electrocardiogram signals (ECG) and the like into independent remote analysis devices. The medical device 500 of the present invention includes: external defibrillation monitors, automatic external defibrillators, or semi-automatic external defibrillators.
The medical device 500 of the present invention comprises a sensing module, a processor and a communication module; the remote analysis device 408 includes a processor and a communication module. The medical device 500 and the remote analysis device 408 transmit the heart parameter information through the communication modules, and if the communication modules are not connected smoothly or the connection is interrupted, the untimely or interrupted information exchange between the medical device 500 and the remote analysis device 408 is caused, so that an error or a fault occurs in the operation of the external cardioversion defibrillation combination device. To avoid this situation, an alarm module may be provided on the external cardioversion-defibrillation combination. An alert module coupled to the controller for providing an alert when activated by the controller, wherein the alert includes at least one or more of an audible, tactile, or visual alert; and a user interface coupled to the controller to receive a response from the patient.
Because a human body has various physiological state parameters, besides an Electrocardiogram (ECG) signal, other various physiological parameters such as heart sound, blood flow, blood pressure, blood sugar and the like, and the sensor is interfered by factors such as external noise, temperature, humidity and the like when identifying the signal parameters, the sensor can identify a plurality of different signal events or can identify various cardiac events according to various signal parameters, and a patient can also suffer from more than one heart disease, which belong to various events.
The external cardioversion-defibrillation combination device of the present invention further comprises: one or more sensors configured to sense a plurality of events, the events comprising: electrocardiogram signals (ECG), heart sounds, blood flow, blood pressure, blood glucose, etc., and returns a sensing result according to the sensing event.
The external cardioversion-defibrillation combination further comprises a processor configured to: prioritizing each of the plurality of events based on an analysis of a severity of each of the plurality of events and a timeliness of required remedial action, and issuing an alert corresponding to a highest priority condition of the plurality of conditions. The processor may not only issue the highest priority alarm, but also suppress lower priority alarms until the highest priority alarm has been remedied.
The medical device 500 of the present invention further comprises a storage module and a memory module, wherein the storage module is used for storing the cardiac parameter data directly sensed by the sensing module, and also storing cardiac parameter messages such as electrocardiogram signals (ECG) transmitted by the medical device 500, the remote analysis device and the remote controller through the communication module; the memory module has a memory function for the memory module for a certain period of time, for example, from the current time to the previous 60 minutes.
The remote analysis device 408 of the present invention has a user interface 502, the user interface 502 has a function of displaying current cardiac parameters, the current settings can be set and controlled by a control button 506 to indirectly control the current physiological parameters of the patient, the control parameters can be displayed on the user interface, and a switch button 504 controls the remote analysis device 408 to be turned on and off. The processor of the remote analysis device is configured to convert current patient cardiac parameter information into a number or image and is further configured to display the number or image to a user interface.
The remote controller is provided with a communication module, a processor and a user display interface; the processor of the remote control is configured to convert the cardiac parameter information obtained from the communication module into a number or image and to display the number or image to a user interface. The remote control apparatus includes: program control appearance, long-range follow-up visit appearance, interface display appearance or other can receive and the instrument of transmission data through the high in the clouds.
The processor of the medical device 500 is configured to first automatically detect the communication status between the medical device 500 and the remote analysis device after activating the communication module of the medical device 500, and when the medical device 500 and the remote analysis device are poorly communicating or the signal is interrupted, the medical device 500 autonomously performs the analysis and identification of the malignant cardiac rhythm event and returns the analysis and identification result. The processor of the remote analysis device 408 is configured to identify from the self status message whether a malignant cardiac rhythm event has occurred and to transmit the result of the identification to the medical device 500. The processor of the medical device 500 is configured to determine whether to activate the therapy module for defibrillation therapy based on the result of the identification.
The combined extracorporeal cardioversion-defibrillation apparatus of the present invention may include only two parts, a medical device 500 and a remote analysis device 408, and may also include a remote control. In clinical practice, in order to reduce the diagnosis error, doctors need to observe the specific physiological parameters of patients and make judgments according to the observation results. In order to facilitate the observation of the physiological parameters of the patient by the doctor, a user display interface is required to be set, and the heart parameter data is displayed to the user display interface in a digital or image mode. The user display interface may be provided directly to the remote analysis device 408; a remote program controller can also be added to the external cardioversion and defibrillation combination device, and a user display interface is arranged on the remote program controller.
Fig. 3 is a schematic diagram illustrating a first method for sharing or synchronizing data of a patient wearing a medical device 500 via a cloud. Fig. 4 is a schematic diagram illustrating a second method for sharing or synchronizing data of a patient wearing the medical device 500 via a cloud. 306 in fig. 3 and fig. 4 represents a patient wearing the medical device 500 of the present invention or the remote analysis device 408, the medical device 500 or the remote analysis device 408 in fig. 3 directly synchronizes the cardiac parameters to the cloud end 304 to implement data sharing, and the medical device 500 or the remote analysis device 408 in fig. 4 implements data sharing by transmitting the cardiac parameters to the cloud end 304 by using the relay device 402 as a communication relay station. The difference between the two methods is whether the medical device 500 or the remote analysis device 408 of the extracorporeal cardioversion defibrillation device of the present invention is used for data sharing by means of the relay device 402. The heart parameter data of the storage and memory module is uploaded to the cloud end through the network cloud 304 to realize cloud storage. The cloud data is shared and synchronized through the terminal device 302, and the terminal device 302 is operated by a doctor. The terminal device of the invention includes, but is not limited to, a computer, a telephone, a mobile phone, a program controller, a remote follow-up device, an interface display device or other devices capable of receiving and transmitting data through the cloud.
The medical device 500 includes three portions, a back structure 508 on which the sensing electrode set is placed, a shoulder strap 102, and a waist strap 114. The back structure 508 of the medical device 500 is connected to a portion of the waist belt 114, while the back structure 508 is connected to the waist belt 114 via the shoulder straps 102. Sensing electrode set 208 and circuitry are disposed within a back structure 508 of medical device 500. Because the external cardioversion and defibrillation combined equipment does not necessarily completely match the body shape of a patient and the equipment shell is hard, more interference factors exist in the process of sensing electrocardiogram signals (ECG), and the sensing of heart parameter data such as the electrocardiogram signals (ECG) becomes more critical. In the combined external cardioversion and defibrillation apparatus, since sensing of a cardiac parameter such as an Electrocardiogram (ECG) signal is performed outside the body through the skin, body tissues and bones, and monitoring of a specific cardiac parameter is affected by noise, temperature, obesity, and the state of contact between an electrode and the skin of a patient, the measured cardiac parameter has a certain error from actual data. To reduce such errors, the electrodes should be as close to the patient's skin as possible; meanwhile, a plurality of pairs of sensing electrodes can be arranged in the medical equipment 500 worn by the patient, so that the sensing accuracy is enhanced, and the sensing error is reduced. The set of electrodes is placed on a medical device 500, is capable of electrically engaging the patient's skin when worn by the patient, and is capable of sensing cardiac parameter information from the patient. The external cardioversion defibrillation combination device of the present invention has both sensing and therapeutic defibrillation functions, so the set of electrodes disposed on the medical device 500 of the present invention includes: a set of at least one pair of electrodes for sensing a patient cardiac parameter electrocardiogram signal (ECG); a set of at least one pair of electrodes for delivering pulses to complete the shock therapy. The sensing electrode 204 and the therapy electrode 202 in fig. 2 and 5 may be the same pair of electrodes or different pairs of electrodes, i.e., one pair of electrodes may have both the function of sensing electrocardiogram signals (ECG) and the function of defibrillation therapy. To implement redundancy of sensing and therapy electrodes, a pair of electrodes may be provided on the medical device 500 to reduce errors in sensing an electrocardiogram signal (ECG).
The shoulder straps 102 of the medical device 500 may be provided with adjustable structure or the shoulder straps may be provided with adjustable tightness but without adjustable structure. The adjustable structure includes but is not limited to a button, a hook, a zipper, a hook and loop fastener, a magnetic connection, or a button. The adjustable structure may be configured in various shapes, such as an oblate shape 104 and a square shape 106, and may also be circular, diamond-shaped, regular polygon-shaped, or a combination of several different shapes. In order to facilitate the patient wearing the medical device 500, the belt 114 is generally provided in several parts, and different parts are connected by an adjustable structure, which may be provided in various shapes, such as an oblate 104 and a square 106, and may also be in a shape of a circle, a diamond, a regular polygon, or a combination of several different shapes. The belt 114 of the medical device 500 is provided with a controller 112, the controller is provided with a switch indication key 108, a switch button 110, and other buttons such as an indication lamp, and the controller 112 is used for implementing operations such as starting, shutting down, parameter setting and the like of the external cardioversion defibrillation device. The belt 114 of the medical device 500 is provided with a fixed structure of the controller 112, such as a pocket, a hanging bag, a hook, or a hanging rope. The in vitro analysis device 408 and the medical device 500 are used in combination for monitoring, identifying and treating heart diseases, such as ventricular fibrillation.
Fig. 6 is a flow chart of a working method of the external cardioversion-defibrillation combination device. The medical device 500 is configured to sense a cardiac parameter of a patient, such as an electrocardiogram signal (ECG), via a sensing module of the medical device 500, see step 602. The communication module of the medical device 500 then transmits the cardiac parameter, e.g., an electrocardiogram signal (ECG), to the remote analysis device 408, see step 610. Before the medical device 500 transmits data to the remote analysis device 408 or before the remote analysis device 408 receives the received data, the medical device 500 and the remote analysis device 408 issue commands to respectively detect whether the communication connection between the two devices is good, step 604, and step 610 is only entered if the two devices detect good contact or at least one of the two devices detects good contact. In the event that the medical device 500 and the remote analysis device 408 detect a poor communication connection, an alarm 606 is issued, and then the processor of the medical device 500 or the remote analysis device 408 performs a retest and reconnect 608, and if the alarm has not been touched, a human check may be performed on the operating status, etc. of the medical device 500 and the remote analysis device 408 and the spatial distance between the two. The alarms are respectively set according to the priority of the event, so that the priority conditions of the event can be distinguished according to the alarms with different degrees. The priority of the event is divided into a first priority, a second priority, a third priority, a fourth priority and the like, and the actual classification level of the priority can be adjusted and set according to specific actual conditions. For example, an alarm for a priority event is set to sound 5 consecutive times, and the occurrence of the whistling sound repeats 3 times, each time with 3 seconds intervals; setting the alarms with the second priority level to continuously sound 4 times; alarms of equal priority are set to whistle 3 times in succession, and so on. Alarms of different priorities may also be set to different colored light flashes or a combination of light flashes and alarm sounds. After the remote analysis device 408 receives the cardiac parameter information from the medical device 500, the processor analyzes and processes the sensed cardiac parameter 612, identifies whether a malignant arrhythmia event occurs or whether a malignant arrhythmia early warning state is entered and returns an analysis and identification result, the remote analysis device 408 judges whether defibrillation treatment is performed according to the analysis and identification result 614, and if a ventricular fibrillation event is not detected, the remote analysis device continues to sense the cardiac parameter (electrocardiogram (ECG) and the like); if a ventricular fibrillation event is detected, the remote analysis device 408 sends a defibrillation command to the medical device 500, step 616, and the medical device 500 receives the therapy command and then shock defibrillation therapy 618.
Fig. 1 is a schematic front perspective image structure of a medical device 500 in a patient-worn external cardioversion-defibrillation combination device; fig. 2 is a schematic diagram of a perspective back view of a medical device 500 in a patient-worn external cardioversion-defibrillation combination device. Taking the example that the patient 100 wears the medical device 500, a method for the patient to wear the medical device 500 and a construction principle of the medical device 500 are specifically explained. Some embodiments of an extracorporeal cardioversion defibrillation device may initiate defibrillation (or delay defibrillation) based on a variety of inputs, of which Electrocardiogram Signals (ECGs) are only one.
Medical device 500 is worn by patient 100 to hold electrode set 208 on patient 100, and is therefore also referred to as a wearable cardioversion defibrillation device. The remote analysis device 408 is placed near the patient 100 during operation, and the distance between the remote analysis device 408 and the patient 100 is generally controlled within 20 meters, because the spatially long distance may cause poor connection or insensitive information transmission between the medical device 500 worn on the patient and the remote analysis device 408, resulting in low communication efficiency and even communication failure. The remote analysis device 408 is therefore positioned as close to the patient 100 as possible during use for diagnostic accuracy and diagnostic effectiveness. The back structure 508 of the medical device 500 is connected to the waist belt 114 through the shoulder straps 102 at the left shoulder P and the right shoulder T of the patient, the elastic straps 206 may be disposed at the lower edge of the waist belt 114 of the medical device 500, and the elastic straps 206 may properly adjust the looseness of the medical device 500, so that the medical device 500 can achieve a better fit with the chest and the back of the patient 100. The waistband 114 and the elastic band 206 of the medical device 500 should be provided with a connecting structure such as a zipper or a button on the front of the chest for the convenience of wearing by the patient. The electrode assembly 208 is disposed in the back structure 508 of the medical device 500, and the external cardioversion defibrillation device of the present invention includes two sensing electrodes 204 and two treatment electrodes 202, each of which may be one or more pairs, and the same pair of electrodes may have both sensing and treatment functions.
The combined extracorporeal cardioversion and defibrillation device of the present invention analyzes sensed cardiac parameters, such as Electrocardiogram (ECG) signals, on a remote analysis device. The analysis of cardiac parameter signals by the present invention is less disturbed by factors than in a WCD, reducing analysis errors. The medical device 500 worn by the patient only senses the cardiac parameter signals and does not need to analyze and process the data like a WCD, which also reduces the workload of the medical device 500 attached to the patient and increases the sensing accuracy. By providing multiple pairs of sensing electrodes within the medical device 500 worn by the patient, sensing accuracy is enhanced and redundancy of sensing and therapeutic signals is reduced.

Claims (13)

1. An external cardioversion-defibrillation combination, characterized in that it comprises: a medical device and a remote analysis device, the medical device worn by a patient to hold an electrode on the patient, including a sensing module, a processor, and a communication module; a remote analysis device comprising a processor and a communication module; the medical device is configured to sense cardiac parameter information of a patient through a sensing module of the medical device, a communication module of the medical device transmits the cardiac parameter to the remote analysis device, a processor of the remote analysis device analyzes and identifies whether a malignant arrhythmia event occurs according to the cardiac parameter and returns an analysis and identification result, when the malignant arrhythmia event occurs, the communication module of the remote analysis device sends a treatment command to the medical device, and the medical device performs electric shock treatment after receiving the treatment command.
2. The external cardioversion-defibrillation combination of claim 1, wherein the medical device comprises a set of one or more pairs of electrodes; the set of electrodes is placed on a medical device, is capable of electrically engaging the patient's skin when worn by the patient, and is capable of sensing cardiac parameter information from the patient.
3. The external cardioversion-defibrillation combination of claim 2, wherein the set of electrodes comprises: a set of at least one pair of electrodes for sensing patient cardiac parameter information; a set of at least one pair of electrodes for delivering pulses to complete the shock therapy.
4. The external cardioversion-defibrillation combination of claim 1, further comprising: an alert module coupled to a controller for providing an alert when activated by the controller, wherein the alert includes at least one or more of an audible, tactile, or visual alert; and a user interface coupled to the controller to receive a response from the patient.
5. The external cardioversion-defibrillation combination of claim 4, further comprising: one or more sensors configured to sense a plurality of events, the events comprising: electrocardiogram signals (ECG), heart sounds, blood flow, blood pressure, blood glucose, etc., and returns a sensing result according to the sensing event.
6. The external cardioversion-defibrillation combination of claim 5, further comprising: a processor configured to: prioritizing each of the plurality of events based on an analysis of a severity of each of the plurality of events and a timeliness of required remedial action, and issuing an alert corresponding to a highest priority condition of the plurality of conditions.
7. The extracorporeal cardioversion-defibrillation combination of claim 1, wherein the medical device further comprises: external defibrillation monitors, automatic external defibrillators, or semi-automatic external defibrillators.
8. The extracorporeal cardioversion-defibrillation combination of claim 1, wherein the remote analysis device has a user interface at which parameters can be indirectly manipulated for a patient's physiological parameters; the processor of the remote analysis device is configured to convert current patient cardiac parameter information into a number or image and is further configured to display the number or image to a user interface.
9. The external cardioversion-defibrillation combination of claim 1, further comprising a remote controller having a communication module, a processor, a user display interface; the processor of the remote control is configured to convert the cardiac parameter information obtained from the communication module into a number or image and to display the number or image to a user interface.
10. The extracorporeal cardioversion-defibrillation combination of claim 9, wherein the remote control comprises: program control appearance, long-range follow-up visit appearance, interface display appearance or other can receive and the instrument of transmission data through the high in the clouds.
11. The extracorporeal cardioversion-defibrillation combination of claim 1, wherein the processor of the medical device is configured to first detect a communication status between the medical device and a remote analysis device upon activation of a communication module of the medical device, wherein the medical device autonomously performs analysis and identification of a malignant cardiac rhythm event and returns the analysis and identification results when the medical device and the remote analysis device are poorly communicating or signaling disrupted.
12. The combination in vitro cardioversion and defibrillation device of claim 1, wherein the processor of the remote analysis device is configured to determine whether a malignant cardiac rhythm event has occurred based on the analysis and identification results and to transmit the analysis and identification results to the medical device.
13. The extracorporeal cardioversion-defibrillation combination of claim 12, wherein the processor of the medical device is configured to determine whether to activate a therapy module for defibrillation therapy based on the result of the identification.
CN202011065851.6A 2020-09-30 2020-09-30 Combined device for external cardioversion and defibrillation Pending CN112022107A (en)

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