Flexible strap type wearable external defibrillator and method

Abstract

The invention belongs to the technical field of medical instruments, and relates to a flexible strap type wearable external defibrillator and a method. The binding belt and the strap are used in cooperation, and the wearing stability and convenience of the strap type wearing assembly are guaranteed. Through reasonable design and layout, the integrated defibrillator host is lighter, thinner and smaller, and the limitation on daily activities of a wearer is reduced. Motion state signals and human body postures are collected in real time through the posture sensor information processing module, various physiological signals of the human body are comprehensively collected through various sensors integrated on the defibrillation electrode, the human body condition can be analyzed more comprehensively and accurately, unnecessary defibrillation operation is reduced, and the safety and reliability of equipment use are improved. On the basis of ensuring the effectiveness of the defibrillation function, the use experience of the user, the wearing convenience and the accurate acquisition and analysis of various physiological signals are comprehensively considered, and the misrecognition rate of the defibrillator is reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology and relates to a flexible strap-type wearable external defibrillator and method. Background Technology

[0002] Currently, defibrillation devices on the market can be divided into three types according to the timeliness of treatment: implantable cardioverter defibrillator (ICD), wearable cardioverter defibrillator (WCD), and automated external defibrillator (AED).

[0003] The core function of a wearable WCD is to continuously monitor the human electrocardiogram (ECG) and provide timely defibrillation treatment when cardiac arrest is detected. The key lies in acquiring the body's ECG and other physiological signals through defibrillation electrodes or ECG electrodes. Upon detecting cardiac arrest, a brief, strong current of 10-35 amperes and 100-200 joules is released to restore a normal heart rhythm. This requires the electrode pads to maintain good contact with the skin at all times to acquire accurate signals.

[0004] Currently, wearable WCD technology and products are mainly divided into two categories: vest-style and patch-style.

[0005] In vest-style WCDs, the electrodes are housed within a vest or garment. Some defibrillation electrodes have exposed metal plates or flexible metal foil electrodes with holes in the center. The conductive gel inside the electrode fills the gaps after the internal motor capsule bursts. Some vests have a mechanism that automatically inflates and presses the electrodes. Other electrodes use a compression spring structure; when defibrillation is detected, the spring is released, causing the electrode to expand and press against the skin for close contact. These devices encapsulate the ECG sensor and defibrillation electrodes within a vest or garment, connected to the main unit via a pluggable electrode cable. The main unit is small and portable. Their advantages include close contact with the skin only when defibrillation is needed, providing a seamless experience and low operating costs. However, the ECG electrodes are dry electrodes, resulting in high noise levels and a high false alarm rate. They are also difficult to put on in water or while showering, affecting sleep comfort.

[0006] The patch-type WCD consists of an integrated main unit and two defibrillation electrodes. The main unit is fixed to the waist electrode, and the chest electrode is connected to the main unit via a cable. The electrodes can be worn for several days, providing long-term reliable monitoring of ECG signals. In the event of cardiac arrest, it directly delivers defibrillation. Its advantages include reliable ECG monitoring using disposable electrodes that last up to 7 days, high-quality ECG signals with a low false alarm rate, and high privacy. Disadvantages include the difficulty in making the main unit's circuit module thin and small, affecting the wearer's daily activities, especially sleeping posture; and the complex and costly manufacturing process of the disposable electrodes, resulting in high initial costs. Summary of the Invention

[0007] The purpose of this invention is to provide a flexible, strap-type wearable external defibrillator and method to solve the technical problems of high false recognition rate and difficulty in wearing vest-type external defibrillators, as well as the difficulty in making patch-type external defibrillators thin and light.

[0008] To achieve the above objectives, the present invention employs the following technical solution: In a first aspect, the present invention provides a flexible, strap-type wearable external defibrillator, comprising: A strap-type wearable component includes a restraint strap and a back strap, wherein the two ends of the restraint strap are detachably connected by connecting buckles, and the back strap is detachably and fixedly connected to the restraint strap; An integrated defibrillator main unit includes a low-voltage power supply and monitoring module, a high-voltage energy storage capacitor module, and a high-voltage charging and discharging module arranged sequentially and fixed on the restraint strap. The low-voltage power supply and monitoring module is equipped with an attitude sensor information processing module, which is used to collect motion state signals and human posture in real time. The low-voltage power supply and monitoring module is used to supply power to the high-voltage energy storage capacitor module and the high-voltage charging and discharging module, and to control the high-voltage energy storage capacitor module to discharge and defibrillate through the high-voltage charging and discharging module; the high-voltage charging and discharging module is used to convert the low-voltage electricity from the low-voltage power supply and monitoring module into high-voltage electricity and store it in the high-voltage energy storage capacitor module. The defibrillation electrodes include LL defibrillation electrode pads and RA defibrillation electrode pads with identical structures, both of which are electrically connected to the high-voltage charging and discharging module and are used for discharge defibrillation; The defibrillation electrode integrates an optical pulse wave sensor and a digital heart sound sensor.

[0009] Secondly, the present invention provides an external defibrillation method based on a flexible strap-type wearable external defibrillator, comprising the following steps: The integrated defibrillator unit can be detachably worn on the wearer's waist using the strap-type wearable component; The wearer's electrocardiogram signal, low voltage impedance signal and optical pulse wave signal are collected in real time, and the motion state signal and human posture are collected in real time using the posture sensor information processing module. The presence or absence of cardiac arrest is determined based on the electrocardiogram signal, the low-voltage impedance signal, the motion state signal, the human posture, and the optical pulse wave signal. If cardiac arrest is identified, further confirmation is made based on the heart sound signal, the transcutaneous optical pulse wave signal, and the respiratory wave in the low-voltage impedance signal. If cardiac arrest is confirmed, a warning will be issued. If a warning reminder termination signal is received by the wearer manually within a set time threshold, the warning reminder will be terminated. Otherwise, the high-voltage charging and discharging module will convert the low-voltage electricity from the low-voltage power supply and monitoring module into high-voltage electricity and store it in the high-voltage energy storage capacitor module. The low-voltage power supply and monitoring module will then control the high-voltage energy storage capacitor module to perform defibrillation through the high-voltage charging and discharging module and the two defibrillation electrodes.

[0010] Compared with the prior art, the present invention has the following beneficial effects: This invention utilizes a restraint strap and a back strap in conjunction to ensure the stability of the back strap-type wearable component. The restraint strap is detachably connected at both ends via buckles, facilitating easy donning and removal and improving usability. The back strap is detachably and securely connected to the restraint strap, allowing for installation or removal according to different usage scenarios and user needs, increasing the device's flexibility and applicability. The integrated defibrillator main unit sequentially arranges and fixes the low-voltage power supply and monitoring module, the high-voltage energy storage capacitor module, and the high-voltage charging and discharging module onto the restraint strap. Through a rational design and layout, it becomes thinner and more compact, reducing restrictions on the wearer's daily activities. The low-voltage power supply and monitoring module supplies power to the high-voltage energy storage capacitor module and the high-voltage charging and discharging module, controlling the high-voltage energy storage capacitor module to perform defibrillation through the high-voltage charging and discharging module; the high-voltage charging and discharging module converts the low-voltage electricity from the low-voltage power supply and monitoring module into high-voltage electricity for storage in the high-voltage energy storage capacitor module. This invention utilizes a posture sensor information processing module to collect motion state signals and human posture in real time, and integrates multiple sensors on the defibrillator electrodes to collect various physiological signals from the human body. This enables a more comprehensive and accurate analysis of the human body's condition, effectively distinguishing between normal physiological activities and abnormal conditions such as cardiac arrest, thereby reducing the false recognition rate, minimizing unnecessary defibrillation operations, and improving the safety and reliability of the device. While ensuring the effectiveness of the defibrillation function, this invention comprehensively considers user experience, ease of wear, and accurate collection and analysis of multiple physiological signals, thus reducing the false recognition rate of the defibrillator.

[0011] This invention comprehensively assesses the wearer's heart and physical condition from multiple dimensions using various physiological and kinematic information. After an initial diagnosis of cardiac arrest, it further combines multiple signals for comprehensive analysis to accurately confirm whether the wearer is in a state of no breathing and no pulse, thus improving the accuracy of cardiac arrest detection. Once the wearer is confirmed to be in a dangerous state of no breathing and no pulse, the device will immediately issue an alert, which helps to enhance emergency response capabilities. If no signal is received from the wearer to manually terminate the alert within a set time threshold, the device will automatically convert low-voltage electricity to high-voltage electricity and store it, and then perform defibrillation through defibrillation electrodes, ensuring rapid and timely treatment of the patient in emergency situations. During the alert period, a time threshold is set and the wearer is allowed to manually terminate the alert, fully considering the possibility of misjudgment. In addition, this invention uses a back strap-style wearable component to detachably wear the integrated defibrillator on the waist. The wearing process is simple and quick, and the position is reasonable and stable. It not only allows users to flexibly put on and take off the device according to their own needs and different scenarios, but also reduces restrictions on the wearer's daily activities, improving comfort and freedom of movement. Attached Figure Description

[0012] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present invention; Figure 2 This is a schematic diagram of the integrated defibrillator main unit structure according to an embodiment of the present invention; Figure 3 This is a functional and control architecture diagram of the integrated host system according to an embodiment of the present invention; Figure 4 This is a circuit diagram of a two-phase high-voltage discharge circuit according to an embodiment of the present invention; Figure 5 This is a flowchart of a method according to an embodiment of the present invention.

[0013] The components include: 100, integrated defibrillator main unit; 110, low-voltage power supply and monitoring module; 111, status indicator and keypad; 112, removable battery module; 113, normally open power supply module; 114, power-off switchable module; 115, main control microcontroller monitoring module; 116, sensor information processing module; 120, high-voltage energy storage capacitor module; 121, capacitor sub-module; 130, high-voltage charging and discharging module; 131, high-voltage charging drive module; 132, high-voltage charging conversion module; 133, high-voltage charging and discharging voltage and current monitoring module; and 134, high-voltage discharging H-bridge module. Block; 135, High-voltage discharge impedance control module; 200, Defibrillator electrode; 210, LL defibrillator electrode pad; 220, RA defibrillator electrode pad; 230, Defibrillator cable; 300, Backband-type wearable component; 301, Restraint strap; 302, Backband; 310, Integrated main unit silicone bracket; 311, Right backband hook end; 312, Left backband hook end; 320, Right retractable fastening strap; 321, Right backband hook end; 330, Left retractable fastening strap; 331, Left backband hook end; 340, Connecting buckle; 350, Right backband; 360, Left backband. Detailed Implementation

[0014] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0015] It should be noted that the terms "first," "second," etc., in the specification and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0016] The present invention will now be described in further detail with reference to the accompanying drawings: See Figure 1 The present invention discloses a flexible strap-type wearable external defibrillator, comprising: a strap-type wearable component 300, an integrated defibrillator host 100, and defibrillation electrodes 200.

[0017] The shoulder strap wearable component 300 includes a restraint strap 301 and a back strap 302. The restraint strap 301 is detachably connected at both ends via connecting buckles 340, facilitating wearing and removal. Users can operate flexibly according to their needs, improving ease of use. The back strap 302 is detachably and fixedly connected to the restraint strap 301, and can be installed or removed according to different usage scenarios and user needs, increasing the flexibility and applicability of the device. The combined use of the restraint strap 301 and the back strap 302 further ensures the stability of the shoulder strap wearable component 300 when worn.

[0018] Compared to vest-style devices, strap-type wearable components offer greater flexibility in terms of wearing methods. The detachable connection between the restraint straps and the shoulder straps allows users to easily adjust the fit according to their needs and the situation. Unlike vest-style devices, they are not difficult to put on in water or while showering, and they do not interfere with sleep, greatly improving user comfort and overall experience.

[0019] In a preferred embodiment of the present invention, the restraint strap 301 and the back strap 302 are made of plastic or knitted fabric.

[0020] In a preferred embodiment of the present invention, the restraint strap 301 comprises: An integrated host silicone bracket 310 is used to assemble the integrated defibrillator host 100; The right retractable fastening strap 320 and the left retractable fastening strap 330 are respectively detachably and fixedly connected to both ends of the integrated host silicone bracket 310. The right retractable fastening strap 320 and the left retractable fastening strap 330 are detachably connected by a connecting buckle 340. The integrated host silicone bracket 310 is connected to the right retractable fastening strap 320 and the left retractable fastening strap 330 via the back strap 302; The integrated host silicone bracket 310 has a host mounting cavity, and the integrated defibrillator host 100 is embedded in the host mounting cavity; Both the integrated host silicone bracket 310 and the integrated defibrillator host 100 are provided with magnetic attraction points. The magnetic attraction points on the integrated host silicone bracket 310 are located inside the host mounting cavity. After the integrated defibrillator host 100 is assembled in the host mounting cavity, the magnetic attraction points on the integrated host silicone bracket 310 correspond to the magnetic attraction points on the integrated defibrillator host 100.

[0021] In a preferred embodiment of the present invention, the integrated host silicone bracket 310 is provided with a right shoulder strap buckle end 311 and a left shoulder strap buckle end 312; the right retractable fastening strap 320 is provided with a right shoulder strap buckle end 321; the left retractable fastening strap 330 is provided with a left shoulder strap buckle end 331; both ends of the right shoulder strap 350 and the left shoulder strap 360 are provided with buckles; the right shoulder strap 350 is fixedly connected to the right shoulder strap buckle end 311 and the right shoulder strap buckle end 321 respectively through the buckles at both ends; the left shoulder strap 360 is fixedly connected to the left shoulder strap buckle end 312 and the left shoulder strap buckle end 331 respectively through the buckles at both ends. The connecting buckle 340 can be a hook-type buckle, Velcro, or an internal belt buckle; The strip-shaped flexible outer shell structure is provided with air gaps; The integrated defibrillator main unit 100 is equipped with a snap-fit ​​connector, and both defibrillation electrodes 200 are connected to the snap-fit ​​connector via defibrillation cables 230. The snap-fit ​​connector is connected to the high-voltage charging and discharging module 130.

[0022] See Figure 2 The integrated defibrillator host 100 includes a low-voltage power supply and monitoring module 110, a high-voltage energy storage capacitor module 120 and a high-voltage charging and discharging module 130 arranged and fixed on the restraint strap 301 in sequence. The low-voltage power supply and monitoring module 110 is equipped with an attitude sensor information processing module, which is used to collect motion state signals and human posture in real time. The integrated defibrillator main unit 100 arranges and fixes the low-voltage power supply and monitoring module, the high-voltage energy storage capacitor module, and the high-voltage charging and discharging module in sequence on the restraint strap. Through reasonable design and layout, compared with the current patch-type external defibrillators, which are difficult to make thin and small main unit circuit modules, this invention optimizes the main unit structure to a certain extent, making it thinner and smaller, reducing the restriction on the wearer's daily activities, especially improving the comfort of the sleeping posture, and improving the convenience of the wearer's daily life.

[0023] The low-voltage power supply and monitoring module 110 is used to supply power to the high-voltage energy storage capacitor module 120 and the high-voltage charge-discharge module 130, and to control the high-voltage energy storage capacitor module 120 to perform discharge defibrillation through the high-voltage charge-discharge module 130 using the LL defibrillation electrode 210 and the RA defibrillation electrode 220; the high-voltage charge-discharge module 130 is used to convert the low-voltage electricity from the low-voltage power supply and monitoring module 110 into high-voltage electricity and store it in the high-voltage energy storage capacitor module 120. The defibrillation electrode 200 includes an LL defibrillation electrode 210 and an RA defibrillation electrode 220 with identical structures. Both the LL defibrillation electrode 210 and the RA defibrillation electrode 220 are electrically connected to the high-voltage charge-discharge module 130 and are used for defibrillation. The defibrillation electrode 200 integrates an optical pulse wave sensor and a digital heart sound sensor.

[0024] This invention uses a posture sensor information processing module to collect motion state signals and human posture in real time, and integrates multiple sensors on the defibrillator electrode to collect various physiological signals of the human body. This enables a more comprehensive and accurate analysis of the human body's condition, effectively distinguishing between normal physiological activities and abnormal conditions such as cardiac arrest, thereby reducing the false recognition rate, reducing unnecessary defibrillation operations, and improving the safety and reliability of the equipment.

[0025] In a preferred embodiment of the present invention, the integrated defibrillator host 100 further includes a strip-shaped flexible shell structure, wherein the low-voltage power supply and monitoring module 110, the high-voltage energy storage capacitor module 120 and the high-voltage charging and discharging module 130 are arranged sequentially and embedded in the strip-shaped flexible shell structure, and the strip-shaped flexible shell structure is fixed on the restraint strap 301. The high-voltage energy storage capacitor module 120 includes six to eight electrically connected capacitor sub-modules 121. The capacitor sub-modules 121 are connected and fixed with flexible insulating material and embedded in the strip-shaped flexible shell structure. The capacitor sub-module 121 is formed by stacking several thin-film capacitors.

[0026] See Figure 3 In a preferred embodiment of the present invention, the low-voltage power supply and monitoring module 110 includes: a status indicator and keypad 111, a removable battery module 112, a normally open power supply module 113, a power supply module 114 that can be turned off, a main control microcontroller monitoring module 115, and a sensor information processing module 116, wherein the attitude sensor information processing module is arranged within the sensor information processing module 116. The detachable battery module 112 is electrically connected to the normally open power supply module 113 and the power-off switchable power supply module 114. The normally open power supply module 113 is electrically connected to the main control microcontroller monitoring module 115, the status indicator and keypad 111, and the sensor information processing module 116. The main control microcontroller monitoring module 115 is connected to the status indicator and keypad 111, the sensor information processing module 116, the power-off switchable power supply module 114, and the high-voltage charging and discharging module 130. The main control microcontroller monitoring module 115 and the sensor information processing module 116 are bidirectionally connected.

[0027] See Figure 3In a preferred embodiment of the present invention, the high-voltage charging and discharging module 130 includes a high-voltage charging drive module 131, a high-voltage charging conversion module 132, a high-voltage charging and discharging voltage and current monitoring module 133, a high-voltage discharging H-bridge module 134, and a high-voltage discharging impedance control module 135. The main control microcontroller monitoring module 115 is connected to the high-voltage charging drive module 131, the high-voltage discharge H-bridge module 134, and the high-voltage discharge impedance control module 135, respectively. The main control microcontroller monitoring module 115 and the high-voltage discharge impedance control module 135 are bidirectionally connected. The power-off module 114 is connected to the high-voltage charging drive module 131. The high-voltage charging drive module 131 is connected to the plurality of capacitor sub-modules 121 through the high-voltage charging conversion module 132. The capacitor sub-modules 121 are connected to the high-voltage discharge H-bridge module 134. The high-voltage discharge H-bridge module 134 is connected to the high-voltage discharge impedance control module 135. The high-voltage discharge H-bridge module 134 is connected to the main control microcontroller monitoring module 115 through the high-voltage charging and discharging voltage and current monitoring module 133. The high-voltage discharge H-bridge module 134 is connected to two defibrillation electrodes 200, respectively.

[0028] In a preferred embodiment of the present invention, the LL defibrillation electrode 210, the RA defibrillation electrode 220, the optical pulse wave sensor, and the digital heart sound sensor are all connected to the main control microcontroller monitoring module 115 through the sensor information processing module 116; The LL defibrillation electrode 210 and the RA defibrillation electrode 220 are also used to acquire transthoracic respiratory impedance and electrocardiogram signals and transmit them to the sensor information processing module 116.

[0029] The optical pulse wave sensor is used to collect pulse signals and send them to the sensor information processing module 116.

[0030] The digital heart sound sensor is used to collect heart sound signals and send them to the sensor information processing module 116.

[0031] The sensor information processing module 116 transmits the acquired signal to the main control microcontroller monitoring module 115.

[0032] The main control microcontroller monitoring module 115 is used to determine whether to initiate external defibrillation based on electrocardiogram signals, pulse signals, heart sound signals, and transthoracic breathing impedance. The transthoracic breathing impedance includes low-voltage impedance signals and high-voltage impedance models.

[0033] While ensuring the effectiveness of defibrillation, this invention comprehensively considers user experience, ease of wear, and accurate acquisition and analysis of various physiological signals, providing a more reliable, comfortable, and convenient solution for the prevention and treatment of emergencies such as cardiac arrest. Moreover, compared with traditional external defibrillators, the external defibrillator of this invention has a simpler manufacturing process, lower cost, and lower initial usage fee, making it highly practical and promising for market application.

[0034] See Figure 5 Based on the aforementioned flexible strap-type wearable external defibrillator, this invention also discloses an external defibrillation method, comprising the following steps: S1, the integrated defibrillator main unit 100 is detachably worn around the wearer's waist using the shoulder strap-type wearable component 300. The two ends of the restraint strap of the shoulder strap-type wearable component are detachably connected via connecting buckles, and the shoulder strap is also detachably and securely connected to the restraint strap, making the entire device wearing process simple and quick. Users can flexibly choose whether to use the shoulder strap for auxiliary fixation according to their own needs and different scenarios, and easily perform wearing and removal operations, greatly improving the convenience of use.

[0035] S2, the wearer’s electrocardiogram signal is collected in real time using an electrocardiogram acquisition sensor, low-pressure impedance signal and respiratory wave signal are collected in real time using a transthoracic respiratory impedance acquisition unit, motion state signal and human posture are collected in real time using the posture sensor information processing module, transcutaneous optical pulse wave signal of peripheral superficial blood vessels is collected in real time using an optical pulse wave sensor, and heart sound signal is collected in real time using a digital heart sound sensor. S3. Based on the electrocardiogram signal, the low-voltage impedance signal, the motion state signal, the human posture, and the optical pulse wave signal, determine whether the wearer is in cardiac arrest. By comprehensively analyzing multiple types of signals, the wearer's cardiac condition is assessed from multiple dimensions, improving the accuracy and reliability of the judgment, reducing the possibility of misjudgment and missed judgment, and lowering the false recognition rate. If cardiac arrest is identified, further confirmation is made based on the heart sound signal, the transcutaneous optical pulse wave signal, and the respiratory wave in the low-voltage impedance signal. After a preliminary judgment of cardiac arrest, comprehensive analysis of the heart sound signal, the transcutaneous optical pulse wave signal, and the respiratory wave in the low-voltage impedance signal allows for a multi-dimensional assessment of the wearer's cardiac condition, more accurately confirming whether the wearer is in a dangerous state of no breathing and no pulse, thereby improving the accuracy and reliability of the judgment, reducing the possibility of misjudgment and missed judgment, and lowering the false recognition rate.

[0036] S4. If cardiac arrest is confirmed, issue a warning and alert to those in the vicinity to improve the ability to respond to sudden cardiac arrest events.

[0037] S5, within a set time threshold, if a warning reminder termination signal is received by the wearer through manual operation, the warning reminder is terminated. In some cases, the warning reminder may be triggered due to device misjudgment or other non-emergency reasons. The wearer can manually terminate the warning reminder after confirming that their condition is normal, avoiding unnecessary tension and interference, and also preventing the device from performing defibrillation operations in non-emergency situations, thus ensuring the wearer's safety. Otherwise, the high-voltage charging and discharging module 130 converts the low-voltage electricity from the low-voltage power supply and monitoring module 110 into high-voltage electricity and stores it in the high-voltage energy storage capacitor module 120. The low-voltage power supply and monitoring module 110 controls the high-voltage energy storage capacitor module 120 to perform defibrillation through the high-voltage charging and discharging module 130 and the two defibrillation electrodes 200.

[0038] In a preferred embodiment of the present invention, the high-voltage charging and discharging module 130 converts the low-voltage electricity from the low-voltage power supply and monitoring module 110 into high-voltage electricity and stores it in the high-voltage energy storage capacitor module 120. The low-voltage power supply and monitoring module 110 controls the high-voltage energy storage capacitor module 120 to perform discharge defibrillation through the high-voltage charging and discharging module 130 and the two defibrillation electrodes 200, including: During the first charge, the low-pressure impedance of the human body through the chest is measured using the dual-frequency method; during subsequent charges, the high-pressure impedance is obtained based on the voltage and current of the previous high-pressure discharge. If the difference between the high-pressure impedance and the low-pressure impedance is greater than a threshold, the high-pressure impedance is used as the human body impedance; otherwise, the low-pressure impedance is used as the human body impedance. Select the charging voltage from the preset charging voltage table based on the human body impedance; The high-voltage charging and discharging module 130 charges the low-voltage power supply and monitoring module 110 into the high-voltage energy storage capacitor module 120 according to the charging voltage. The low-voltage power supply and monitoring module 110 controls the high-voltage energy storage capacitor module 120 to perform defibrillation through the high-voltage charging and discharging module 130 and the two defibrillation electrodes 200 based on the human body impedance and defibrillation energy, and according to the preset discharge waveform control data.

[0039] In a preferred embodiment of the present invention, obtaining the high-voltage impedance based on the voltage and current of the previous high-voltage discharge includes: Within 100-150µs before the start of high-voltage discharge, several sets of current and voltage values ​​are continuously collected through the two defibrillation electrodes 200. After averaging the current and voltage values, Ohm's law is used to calculate the total impedance of the high-voltage discharge circuit. The high-voltage impedance is obtained by subtracting the impedance of the LL defibrillator electrode 210, the impedance of the RA defibrillator electrode 220, and the impedance of the high-voltage discharge impedance control module 135 from the total impedance of the high-voltage discharge circuit.

[0040] This invention comprehensively assesses the wearer's heart and physical condition from multiple dimensions using various physiological and kinematic information. Different signals corroborate and complement each other, effectively avoiding misjudgments caused by interference or individual differences from a single signal, significantly improving the accuracy of cardiac arrest detection. After a preliminary judgment of cardiac arrest, further comprehensive analysis of multiple signals accurately confirms whether the wearer is in a state of no breathing and no pulse, further improving the accuracy of the judgment. Once the wearer is confirmed to be in a dangerous state of no breathing and no pulse, the device will immediately issue an alert, quickly notifying those around, which helps enhance emergency response capabilities and improve the patient's chances of survival. Within a set time threshold, if no signal is received from the wearer to manually terminate the alert, the device will automatically convert low-voltage electricity to high-voltage electricity and store it, then deliver defibrillation through defibrillation electrodes. This automated process ensures rapid and timely treatment of patients in emergency situations, maximizing the restoration of normal heart rhythm and reducing adverse consequences caused by delayed treatment. Setting a time threshold and allowing the wearer to manually terminate the alert fully considers possible misjudgments. The integrated defibrillator unit is detachably worn on the waist using a back strap-style wearable component. The wearing process is simple and quick, and the position is reasonable and stable. It not only allows users to flexibly put on and take off the device according to their own needs and different scenarios, but also reduces restrictions on the wearer's daily activities, improving comfort and freedom of movement.

[0041] Example 2: See Figure 1 This embodiment discloses a flexible strap-type wearable external defibrillator, including: an integrated defibrillator main unit 100, defibrillation electrodes 200, and a strap-type wearable component 300.

[0042] See Figure 2 The integrated defibrillator main unit 100 includes a low-voltage power supply and monitoring module 110, a thin-film high-voltage energy storage capacitor module 120, and a high-voltage charging and discharging module 130; it is encapsulated in a strip-shaped flexible shell structure that can be bent and rolled up, and there are air gaps between the modules; the encapsulation material is silicone or plastic, which can directly contact human skin.

[0043] See Figure 1The defibrillator electrode 200 is a disposable, detachable defibrillator electrode, including an LL defibrillator electrode pad 210 and an RA defibrillator electrode pad 220, a defibrillator cable 230, and a plug. The defibrillator electrode 200 is connected to the integrated defibrillator main unit 100 via the defibrillator cable 230. The defibrillator cable 230 is connected to the integrated defibrillator main unit 100 via a snap-fit ​​connector with a locking function at the end. The defibrillator cable 230 is connected to the LL defibrillator electrode pad 210 and the RA defibrillator electrode pad 220 respectively. These two types of defibrillator electrode pads support continuous wear for 7 to 15 days. The electrode pads are made of adhesive material that is non-allergenic, non-toxic, and non-irritating to human skin within 7 to 15 days, and has good breathability and moisture permeability to human skin during wear. The conductive part of the electrode pad has a waterproof and moisturizing design to ensure that the conductive gel will not lose water and denature due to heat from human skin during wear, thereby avoiding dehydration that would lead to a decrease in defibrillation effect and to avoid noise in the electrocardiogram signal.

[0044] See Figure 1 The strap-type wearable component 300 includes: a restraint strap 301 and a back strap 302. The restraint strap includes an integrated host silicone bracket 310, a right retractable fastening strap 320, a left retractable fastening strap 330, and a connecting buckle 340. The back strap includes a left back strap 360 and a right back strap 350.

[0045] The integrated host silicone bracket 310 is a long, bendable, pocket-shaped structure with buckle structures on its upper and lower edges and a magnetic attraction point in the middle for clamping and adsorbing the integrated defibrillator host 100. The integrated host silicone bracket 310 is connected and locked together with the fastening structures of the right retractable fastening strap 320 and the left retractable fastening strap 330 through the locking slots at both ends.

[0046] The right retractable fastening strap 320 and the left retractable fastening strap 330 are connected and locked together by a connecting buckle 340.

[0047] The integrated host silicone bracket 310, the right retractable fastening strap 320 and the left retractable fastening strap 330 can be connected to form a waist-loop wearable carrier, so that the integrated host can be worn around the waist.

[0048] See Figure 1 The integrated host silicone bracket 310 has a right shoulder strap buckle end 311, and the right retractable fastening strap 320 has a right shoulder strap buckle end 321. The right shoulder strap 350 is fixed to the right shoulder strap buckle end 311 and the right shoulder strap buckle end 321 respectively through the buckle structure at both ends. The integrated host silicone bracket 310 has a left shoulder strap buckle end 312, and the left retractable fastening strap 330 has a left shoulder strap buckle end 331. The left shoulder strap 360 is fixed to the left shoulder strap buckle end 312 and the left shoulder strap buckle end 331 respectively through the buckle structure at both ends.

[0049] The left shoulder strap 360 and the right shoulder strap 350 pass over the wearer's shoulders from the front of the integrated host silicone bracket 310 and are installed parallel to each other on both sides of the back fastening strap, or pass over the shoulders and cross over to the right retractable fastening strap 320 and the left retractable fastening strap 330.

[0050] The left shoulder strap 360 and the right shoulder strap 350 are load-bearing straps made of waterproof, dustproof, breathable and soft textiles. They are non-elastic and are used to support the weight of the integrated defibrillator main unit 100 and the shoulder strap wearable component 300 when the waist-loop wearable component 300 is loosely fastened.

[0051] In this embodiment of the invention, the connecting buckle 340 can be a hook-type, Velcro, or internal belt buckle, etc., to reliably connect the left and right fastening straps together. Optionally, the fastening straps can be made of waterproof materials such as leather or silicone, supporting the wearer's daily environment such as sweating during exercise or showering.

[0052] In this embodiment of the invention, the right retractable fastening strap 320 and the left retractable fastening strap 330 can be made of waterproof materials such as leather and silicone, supporting the wearer in daily environments such as exercise, sweating, and showering.

[0053] In this embodiment of the invention, the flexible integrated defibrillator main unit 100 is detachably installed in an integrated main unit silicone bracket 310 made of flexible silicone material. The flexible integrated defibrillator main unit 100 is fixed together with the integrated main unit silicone bracket 310 by a buckle on the back and magnetic material.

[0054] In this embodiment of the invention, the integrated host silicone bracket 310, the right retractable fastening strap 320, the left retractable fastening strap 330, the right back strap 350, and the left back strap 360 are all detachable and can be disassembled into individual components, which facilitates washing, cleaning, maintenance, and replacement.

[0055] See Figure 2 In this embodiment of the invention, the flexible integrated defibrillator host 100 is a flat, strip-shaped, flexible, and bendable structure. The flexible integrated defibrillator host 100 includes a low-voltage power supply and monitoring module 110, a high-voltage energy storage capacitor module 120, and a high-voltage charging and discharging module 130.

[0056] The low-voltage power supply and monitoring module 110 and the high-voltage charging and discharging module 130 are packaged at both ends of the flexible integrated defibrillator main unit 100, with the high-voltage energy storage capacitor module 120 in the middle. When the high-voltage energy storage capacitor module 120 is stacked in three layers, the structural thickness of the flexible integrated defibrillator main unit 100 does not exceed 3 cm, the width does not exceed 8 cm, and the length does not exceed 25 cm.

[0057] The low-voltage power supply and monitoring module 110 and the high-voltage charging and discharging module 130 are respectively encapsulated in 2 to 3 flexible hard plastic or silicone shells. The high-voltage energy storage capacitor module 120 is respectively encapsulated in 6 to 8 flexible hard plastic or silicone shells. The connecting material between the shells is flexible plastic or silicone, with hollow holes or gaps, which are breathable and bendable to adapt to the curvature of the human torso.

[0058] In this embodiment of the invention, when the high-voltage energy storage capacitor module 120 is stacked in two layers, the thickness of the flexible integrated defibrillator host 100 does not exceed 2 cm and the length does not exceed 30 cm.

[0059] See Figure 3 This is a layout diagram of the various modules inside the integrated defibrillator host 100 in this embodiment.

[0060] The low-voltage power supply and monitoring module 110 is divided into six sub-modules: a status indicator and keypad 111, a removable battery module 112, a normally open power supply module 113, a power-off switchable power supply module 114, a main control microcontroller monitoring module 115, and a sensor information processing module 116. These six sub-module circuits are stacked in 2 to 3 structurally separate circuit spaces. The removable battery module 112 is independent and internally encapsulates the two types of lithium battery cells shown in Table 2. The status indicator and keypad 111, normally open power supply module 113, power-off switchable power supply module 114, main control microcontroller monitoring module 115, and sensor information processing module 116 are integrated into one structural space.

[0061] The high-voltage energy storage capacitor module 120, according to the capacitor combinations shown in Table 1, involves stacking two capacitors and then combining them in series and parallel to form a high-voltage energy storage capacitor through internal wires. Preferably, a 1600V-135uF combined capacitor is used. This combination uses 12 400V-180uF thin-film capacitors, with three capacitors connected in parallel to form a group, and a total of four groups connected in series to form the high-voltage energy storage capacitor module 120. Each pair of capacitors is stacked to form six capacitor sub-modules 121, which are connected together by internal flexible cables. The six capacitor sub-modules 121 are encapsulated in flexible silicone to form six sub-structural modules. The connections between the six sub-structural modules are also made of flexible silicone and flexible cables, allowing the capacitor modules to be bent. As shown in Table 1, the secondary option is to use a combination of 1800V-140uF capacitors. This combination uses 16 450V-140uF thin-film capacitors. Every four capacitors are connected in parallel to form a group, and the four groups are connected in series to form a high-voltage energy storage capacitor module 120. Every two capacitors are stacked to form a total of 8 capacitor sub-modules 121. Similarly, these 8 capacitor sub-modules 121 are also flexible and bendable after being encapsulated with flexible silicone.

[0062] Table 1. Optional Capacitor Combination Specifications:

[0063] The high-voltage charging and discharging module 130 includes a high-voltage charging drive module 131, a high-voltage charging conversion module 132, a high-voltage charging and discharging voltage and current monitoring module 133, a high-voltage discharging H-bridge module 134, and a high-voltage discharging impedance control module 135. These five circuit units are structurally stacked in two structural modules according to their charging and discharging functions, component sizes, and shapes. The high-voltage charging drive module 131 and the high-voltage charging conversion module 132 can be encapsulated in one structural space, while the high-voltage charging and discharging voltage and current monitoring module 133, the high-voltage discharging H-bridge module 134, and the high-voltage discharging impedance control module 135 are encapsulated in a second structural space. Similarly, the two structural modules are flexibly connected and can be bent to a certain extent.

[0064] Figure 3 The diagram shown is a system architecture diagram of the functions and control relationships between the various modules inside the integrated defibrillator host 100 of the present invention. Specifically, it includes: a status indicator and keypad 111, a removable battery module 112, a normally open power supply module 113, a power-off switchable module 114, a main control microcontroller monitoring module 115, a sensor information processing module 116; a capacitor sub-module 121, a high-voltage charging drive module 131, a high-voltage charging conversion module 132, a high-voltage charging and discharging voltage and current monitoring module 133, a high-voltage discharging H-bridge module 134, and a high-voltage discharging impedance control module 135.

[0065] The removable battery module 112 is a battery pack with specifications of 6V@2A and 2500mAh composed of disposable CR123A lithium batteries as described in Table 2, or a rechargeable lithium battery pack with specifications of 7.4V@6A and 3000mAh composed of polymer lithium batteries. The removable battery module 112 provides power to the low-voltage power supply and some components of the monitoring module 110 inside the integrated defibrillator main unit 100, the high-voltage energy storage capacitor module 120, and the high-voltage charge / discharge module 130. The removable battery module 112 is directly connected to the normally open power supply module 113 and the turn-off power supply module 114.

[0066] Table 2. Optional Removable Battery Specifications:

[0067] The normally open power supply module 113 converts the 4.5V~8.4V voltage output from the removable battery module 112 into a 3.3V output. The normally open power supply module 113 is directly and unidirectionally connected to the main control microcontroller monitoring module 115, the status indicator and keypad 111, and the sensor information processing module 116, providing these modules with a 3.3V DC power supply.

[0068] The main control microcontroller monitoring module 115 includes a real-time calendar system RTC (Real-Time Clock) chip, SDRAM (Synchronous Dynamic Random Access Memory), a USB interface (Universal Serial Bus), and a large-capacity NAND Flash memory component. It is responsible for implementing all control and calculation functions of the integrated defibrillator host 100, as well as collecting and storing important information, such as performing power-on self-tests, cardiac arrest status recognition, human posture and status recognition, high-voltage charging control, high-voltage discharge control, discharge cancellation detection and control, electrode adhesion quality detection, time synchronization, warning and alarm control, device status indication, real-time remote signal and data communication, remote alarm and information interconnection, and dynamic battery management.

[0069] The sensor information processing module 116 includes an electrocardiogram acquisition sensor, a transthoracic respiratory impedance acquisition unit, a six-axis accelerometer information processing module, a gyroscope sensor information processing module, a heart sound acquisition sensor, and a transcutaneous optical pulse wave acquisition circuit.

[0070] The status indicator and keypad 111 includes LED light-emitting diodes, light-emitting diode status indicators, small-sized OLED organic light-emitting diodes, organic light-emitting diode liquid crystal displays and other visual interactive display devices, as well as audible prompts and warning devices such as buzzers, vibration motors, and speakers, and two user confirmation input buttons. In addition, it includes WIFI wireless local area network, Wireless Local Area Network, BLE Bluetooth Low Energy and Bluetooth Low Energy and 4G / 5G and other long-range wireless communication modules.

[0071] Under normal circumstances, the normally open power supply module 113 is continuously in operation after the battery is installed in the device. Powered by the normally open power supply module 113, the main control microcontroller monitoring module 115 controls the sensor information processing module 116 to continuously collect several physiological signals related to cardiac arrest through the sensors on the LL defibrillator electrode pad 210 and RA defibrillator electrode pad 220 in low power mode. Optionally, the LL defibrillator electrode pad 210 and RA defibrillator electrode pad 220 of the defibrillator electrode 200 integrate an attitude sensor information processing module, a transthoracic respiratory impedance acquisition unit, an electrocardiogram acquisition sensor, an optical pulse wave sensor, and a digital heart sound sensor. The information is then transmitted to the sensor information processing module 116 and then to the main control microcontroller monitoring module 115. The main control microcontroller monitoring module 115 uses electrocardiogram (ECG) signals and low-voltage impedance signals, combined with human posture and movement status, to identify whether the collected signals are non-interference signals that can be analyzed and identified. If they are interference signals or data that cannot be analyzed and identified, the module continues to wait for the signals to return to normal. If the signals are analyzable, the module identifies whether the wearer is in cardiac arrest. If in cardiac arrest, the module can optionally collect heart sound signals and transcutaneous optical pulse wave signals, and combine them with respiratory waves in the low-voltage impedance signal to comprehensively verify or confirm whether the wearer is in a state of no breathing and no pulse. If confirmed, the module controls the status indicator and button panel 111 to perform progressively escalating reminders and warnings such as motor vibration, buzzer alarm, and speaker sound within one minute at different time intervals. If the wearer believes that their condition is good and that the device is misidentifying and does not require defibrillation treatment, they can simultaneously press and hold both buttons on the status indicator and button panel 111 to cancel and terminate the subsequent defibrillation treatment. Pressing and holding both buttons simultaneously is to avoid accidental triggering by a single button.

[0072] It should be noted that, generally, the digital sensors for collecting human heart sounds, posture, and optical pulse waves are set on the integrated defibrillator main unit 100; optionally, the digital sensors for collecting human heart sounds, posture, and optical pulse waves of the present invention are set on the LL defibrillator electrode pad 210 or the RA defibrillator electrode pad 220, and various digitized human movement and electrophysiological signals are transmitted to the sensor information processing module 116 of the integrated defibrillator main unit 100 through the defibrillator cable 230.

[0073] The power-off module 114 connects the removable battery module 112 and the main control microcontroller monitoring module 115, and is the main power source for the high-voltage charging and discharging module 130. It only starts working under the control of the main control microcontroller monitoring module 115 when the wearer needs defibrillation treatment or when the charging and discharging circuit needs self-testing. Therefore, most of the time, the power-off module 114 and the high-voltage charging and discharging module 130 are in a power-off state.

[0074] The real-time recognition algorithm running within the main control microcontroller monitoring module 115 detects that the wearer is in cardiac arrest requiring defibrillation, or that the wearer has pressed and held a button to initiate a forced function self-test. In response, the main control microcontroller monitoring module 115 controls the opening of a high-current controllable P-NMOS switch inside the power switchable power module 114, connecting the output of the removable battery module 112 and the inputs of the normally open power module 113 and the power switchable power module 114. Through internal power conversion components, it outputs the required DC operating voltages (3.3V, 5V, etc.) for the charging and discharging circuit. Simultaneously, the main control microcontroller monitoring module 115 connects to the high-voltage charging drive module 131, outputting a high-charge drive signal. The high-voltage charging drive module 131 connects to the high-voltage charging conversion module 132. Under the excitation of the drive signal, the high-voltage charging conversion module 132 outputs a charging current, which, under the control of the high-voltage charging and discharging voltage and current monitoring module 133, charges the high-voltage energy storage capacitor module 120 to a preset high voltage between 1600V and 2000V.

[0075] Under the control of the discharge self-test or discharge treatment process, the main control microcontroller monitoring module 115, through its connection with the high-voltage charging and discharging voltage and current monitoring module 133, the high-voltage discharge H-bridge module 134, and the high-voltage discharge impedance control module 135, controls the four high-voltage MOS switches numbered H1~H4 inside the high-voltage discharge H-bridge module 134, and controls several high-voltage impedance short-circuit switches inside the high-voltage discharge impedance control module 135 to adjust the impedance, thereby completing the entire discharge process. (See [link to relevant documentation]). Figure 4 This is a circuit diagram for a two-phase high-voltage discharge circuit.

[0076] First, the main control microcontroller monitoring module 115 controls the cross-conduction of H1 and H4, allowing the electrical energy stored in the high-voltage energy storage capacitor module 120 to flow as current through the H1 bridge switch to the LL defibrillator electrode 210. The current then enters the body through the lower left rib area, flows directly through the heart, reaches the RA defibrillator electrode 220 on the upper right shoulder, then flows through the H4 bridge switch, exits the high-voltage discharge H-bridge module 134, and flows into the circuit through the connection with the high-voltage discharge impedance control module 135. Under the control of the main control microcontroller monitoring module 115, the high-voltage discharge impedance control module 135 dynamically switches the internal discharge resistor short-circuit MOS or IGBT electronic switch according to a preset resistance value, changing with the discharge time and voltage, forming a discharge resistance value matched to the discharge voltage and discharge time. After the high-voltage discharge current flows through the controlled high-voltage discharge impedance control module 135, it flows into the ground signal terminal of the high-voltage energy storage capacitor module 120, thus forming the first phase of the biphasic defibrillation discharge waveform flowing from the apex of the heart into the heart.

[0077] The main control microcontroller monitoring module 115 maintains the H1 and H4 of the high-voltage discharge H-bridge module 134 continuously open the first phase for 6ms, or the two-phase exponentially decaying wave for a preset time of 2~12ms according to the high-voltage discharge impedance.

[0078] Next, the main control microcontroller monitoring module 115 controls the shutdown of H1 and H4 and waits for 100-200µs. During this time, since all four high-voltage MOS electronic switches of the H-bridge are in the off state, there is no discharge current in the high-voltage discharge circuit. This also allows the charge on the parasitic capacitances of the components in the high-voltage discharge circuit to be released naturally, eliminating the risk of damage to the high-voltage components when the circuit outputs a second reverse current. During this period, no current flows through the human body, including the heart.

[0079] Then, the main control microcontroller monitoring module 115 controls the H2 and H3 high-voltage electronic switches inside the high-voltage discharge H-bridge module 134 to cross-conduct, so that the electrical energy stored in the high-voltage energy storage capacitor module 120 is again delivered as current through the H2 bridge switch to the RA defibrillator electrode 220 on the upper right shoulder. From there, it enters the body through the right pectoral muscles, flows through the heart, reaches the LL defibrillator electrode 210 on the lower left rib, and then flows through the H3 bridge switch, exiting the high-voltage discharge H-bridge module 134 and inputting to the high-voltage discharge impedance control module 135. Under the control of the main control microcontroller monitoring module 115, all the short-circuit electronic switches of the discharge resistor inside the high-voltage discharge impedance control module 135 are short-circuited, and the discharge resistance becomes 0 ohms. After the high-voltage discharge current flows through the 0-ohm high-voltage discharge impedance control module 135, it flows into the ground signal terminal of the high-voltage energy storage capacitor module 120, thus forming the second phase of the biphasic defibrillation discharge waveform flowing from the posterior end of the heart to the apex.

[0080] The main control microcontroller monitoring module 115 maintains the second phase of the high-voltage discharge H-bridge module 134, H2 and H3, continuously open for 4ms, or the two-phase exponentially decaying wave for a preset time of 2~16ms according to the high-voltage discharge impedance.

[0081] Specifically, before high-voltage charging begins, the main control microcontroller monitoring module 115, through the low-voltage impedance measurement circuit in the sensor information processing module 116, uses the method of controlling the dual-frequency drive signal described in patent application CN118766431 to accurately measure the low-voltage impedance R of the human body. TTI The low-voltage impedance R measured by this low-voltage AC method TTI The high-voltage impedance R measured by high-voltage discharge HVThe error is less than 1 ohm. The human body impedance range of the external defibrillator system described in this invention is 10~300 ohms. Relevant professional standards for external defibrillator equipment stipulate that external defibrillator equipment must specify the discharge characteristics at each 25-ohm impedance step within the range of 25~175 ohms. The system described in this invention divides the human body impedance range of 10~300 ohms into 7 energy levels N=1~7 according to the characteristic of 25-ohm increments, following the intervals of 25*N-15 and 25*N+10, with the last level having a resistance range of 160~300 ohms.

[0082] The integrated defibrillator main unit 100 has preset energy settings of 50J, 70J, 85J and 120J, 150J, 200J respectively, for children and adults. Based on the aforementioned seven impedance ranges, the charging values ​​V11~V76 of the 42 preset high-voltage energy storage capacitor modules listed in Table 3 are also set. When the main control microcontroller monitoring module 115 measures the low-voltage impedance R of the human body... TTI Next, first determine the resistance range L according to Table 3. R L1~L7, and then based on the discharge energy, obtain the voltage value required for charging, which is used as the target charging value V. HV .

[0083] Table 3. Preset Charging Voltage Meter:

[0084] After high-voltage charging begins, the main control microcontroller monitoring module 115 periodically detects the voltage on the high-voltage energy storage capacitor module 120 output by the high-voltage charging and discharging voltage and current monitoring module 133. When the measured voltage is greater than the charging voltage V, the system will detect the voltage. HV Charging stops at this point. Preparations begin for the defibrillation discharge phase.

[0085] In this embodiment of the invention, the method for presetting the charging voltage is as follows: S1: Measurement of transthoracic low-pressure impedance R of the human body using the dual-frequency method TTI ; S2: Based on the impedance measurement range, the resistance is divided into seven levels; S3: The preset discharge energy is set to six levels according to adults and children; S4: Set 42 preset charging voltage combinations according to the seven resistance levels and six output energy levels to form a preset charging voltage standard; S5: Based on the low voltage impedance R TTI Determine the Ln value for resistor ranges L1 to L7; S6: Determine the charging voltage V by referring to the table based on the current output defibrillation energy. HV ; S7: During non-first charging, the high-voltage impedance R is calculated in real time based on the high-voltage discharge voltage and current measured by the multi-point averaging method 100us-150us before the last actual start of high-voltage discharge. HV Adjust resistor ranges L1 to L7 based on the results; provide feedback on the subsequent charging voltage.

[0086] Optionally, the SC7 can rapidly and continuously acquire 3 to 5 pairs of voltage values ​​V within the first 100 to 150 µs of discharge. hv and current value I hv After averaging the real-time values, Ohm's law is used to calculate the total impedance R of the high-voltage discharge circuit. hv Then subtract the impedances (approximately 2-10 ohms) of the LL defibrillation electrode pad 210 and the RA defibrillation electrode pad 220, as well as the impedance R of the high-voltage discharge impedance control module 135. var (Usually 50 ohms), the high voltage resistance R of the human body can be obtained. HV Then, based on the high voltage impedance R HV and low voltage resistance R TTI The difference determines whether L needs to be changed. R And the corrected charging voltage V HV .

[0087] After the discharge process begins, in the actual high-voltage discharge process, the main control microcontroller monitoring module 115 does not control each high-voltage electronic switch step by step to achieve a two-phase square wave or two-phase exponentially decaying cutoff wave discharge waveform as described in the previous discharge principle. Instead, it first calculates and designs the entire discharge process into minimum controllable intervals, such as 0.1ms. Then, it determines the duration interval between the first phase, the stop discharge interval, and every two current control time points within the second phase discharge time period. It calculates the required duration multiple of 0.1ms and the switch table of all controllable high-voltage electronic switches at each current control time point. The state of each switch is represented by 1 bit, and the control of all switches is... The control state forms a switch control word, forming a list of {time, switch control word} data pairs describing the complete discharge process. Since there are 7 resistance levels and 6 output defibrillation energies, it is necessary to predefine 42 different resistance levels and output energies to measure the {time, switch control word} data pairs. Then, after the main control microcontroller monitoring module 115 starts the discharge process, it internally reads the measured human body resistance level Ln and the current output energy, selects the corresponding {time multiple, switch control word} data pair discharge control table, and then, under the control of the 0.1ms timer, in the timer interrupt judgment, according to the timer length, when the timer multiple is reached, it outputs the specified on / off state of all switches.

[0088] In this embodiment of the invention, the control method for the two-phase discharge waveform is as follows: SD1: Based on seven resistance levels and six defibrillation energy levels, a control list of 42 discharge waveforms is determined; First, determine the minimum controllable time period of each discharge waveform during the entire discharge phase as the discharge timer period T. n For example, 0.1ms divides the entire discharge time into N T segments. n And determine the timing cycle multiple of the time period between each adjacent control point within the discharge time period, as well as the high voltage electrons in the discharge circuit at that moment, to form a discharge waveform control data pair {timing cycle multiple, switch control word} array list; SD2: Based on the determined resistor range Ln and output energy level, select the corresponding {timing cycle multiple, switch control word} data pair list; SD3: Outputs the first switch control word, sets the internal high-voltage discharge impedance control module to a maximum impedance of 50 ohms; sets the H1 and H4 high-voltage electronic switches of the discharge H-bridge to be turned on; SD4: The high-voltage discharge voltage V on the high-voltage energy storage capacitor module 120 is measured by rapid cyclic multi-point sampling and averaging method during the first 100us-150us of high-voltage discharge. HV1 and high voltage discharge current I HV Real-time calculation of high voltage impedance R HV ; SD5: Based on the high voltage impedance R HV and low voltage resistance R TTI Re-evaluate and set the resistance range Ln of L1-L7; SD6: Select the corresponding discharge time and impedance configuration table based on the resistance range Ln and the output energy En; SD7: Based on the timing of H-bridge electronic switches H1-H4 and electronic switches K1-K5 inside the high-voltage discharge impedance control module in the {discharge time multiple, electronic switch status} table, the SD7 controls the opening and closing of the 9 electronic switches according to the time rhythm, and completes the discharge time and dynamic impedance transformation control of the first phase of discharge current, discharge stop interval, the specified time point of the second phase.

[0089] SD8: Collects the voltage between the two defibrillation electrodes 200 and the discharge current passing through the human body during the S6 discharge phase; SD9: Calculate the voltage difference between the two defibrillation electrodes 200 in the first and second phases of stages S2 and S6. Calculate the total discharge energy using voltage, current, sampling period, and number of sampling points. After the system confirms that the discharge process can begin, the main control microcontroller monitoring module 115 continues to use a cycle of The sampling interval is used to monitor the real-time voltage V on the high-voltage energy storage capacitor module 120 output by the high-voltage charging and discharging voltage and current monitoring module 133. hv1And the current I flowing through the human body hv and voltage V hv2 At the end of the discharge, it can be achieved through Calculate the actual output energy; in, To release defibrillation energy into the body; This represents the number of sampling points within the discharge time period; The first to flow into the human body The sampling voltage is the real-time voltage on the high-voltage energy storage capacitor. The first to flow out of the human body Each sampling voltage; For the first person to flow through the human body One sampling current; The sampling interval is denoted as .

[0090] Optionally, this method supports two discharge waveforms: biphase square wave and biphase exponentially decaying cutoff wave.

[0091] Optionally, children can select either 50 joules or 70 joules as the preset energy, with 50 joules selected as the default output energy for the first defibrillation. Adults can select either 120 joules or 150 joules as the preset energy, with 120 joules selected as the default output energy for the first defibrillation. Generally, 50 ohms is selected as the default human body impedance and L2 as the resistance setting. Furthermore, a measured RTTI of less than 10 ohms is used as the threshold for judging a short circuit in the system's discharge circuit. If this is the case, it indicates a possible short circuit in the electrode pads, and discharge should be stopped.

[0092] It should be emphasized that the above charging and discharging methods and steps are suitable for biphasic square wave defibrillation waveforms and biphasic exponentially decaying cutoff wave discharge waveforms. However, the contents of the 42 charging preset tables and the 42 data pairs (discharge time multiple, control switch word) corresponding to the two defibrillation waveforms are different under the two convenient waveforms.

[0093] A current clinical application problem with vest-style and patch-style WCDs is that during daily activities, motion interference leads to a high false alarm rate in the recognition algorithm, requiring the wearer to manually cancel the charging and defibrillation process caused by the false alarm. To reduce the false alarm rate in cardiac arrest, this invention uses the absence of breathing and pulse in cardiac arrest to confirm the heart rhythm result identified through electrocardiogram signals. The specific implementation process is as follows.

[0094] When the wearer is in cardiac arrest, because blood no longer enters the extracardiac arteries from the left and right ventricles of the heart, pulmonary and systemic circulation cease. Changes in the optical pulse wave cannot be detected from the skin surface, nor can the first and second heart sounds formed by the atrial and ventricular arteries be detected. Therefore, the inability to detect the optical pulse wave and heart sound characteristics is also a contributing feature of cardiac arrest.

[0095] Because the brain enters a state of unconsciousness due to oxygen deprivation after a prolonged period of cardiac arrest, the respiratory center loses control, and therefore the wearer stops breathing, making it impossible to detect low-impedance respiratory waves. The inability to detect respiratory waves within low-impedance signals is thus a contributing characteristic of cardiac arrest.

[0096] By comprehensively identifying cardiac arrest using electrocardiogram signals, optical pulse wave signals, heart sound signals, and low-pressure impedance respiratory wave signals, false identification can be greatly reduced, thereby improving the clinical experience.

[0097] If the ECG signal has significant noise or shows signs of electrode detachment, the ECG signal cannot be used for analysis and identification. The system will wait for the ECG signal to return to normal and will alert the wearer to check and repair the quality of the electrode pads, or prompt the wearer to replace the defibrillation electrode pads with new ones. If the ECG signal cannot be restored after the set time, and other auxiliary low-impedance respiratory waves, optical pulse waves, and heart sound signals cannot detect normal blood circulation rhythm characteristics, the system will alert the wearer, stop the monitoring process, issue an alarm, and remotely notify the responsible personnel that the device has malfunctioned.

[0098] The above content is only for illustrating the technical concept of the present invention and should not be construed as limiting the scope of protection of the present invention. Any modifications made to the technical solution based on the technical concept proposed in this invention shall fall within the scope of protection of this invention.

Claims

1. A flexible, strap-type wearable external defibrillator, characterized in that, include: The strap-type wearable component (300) includes a restraint strap (301) and a back strap (302), wherein the two ends of the restraint strap (301) are detachably connected by connecting buckles (340), and the back strap (302) is detachably and fixedly connected to the restraint strap (301). An integrated defibrillator host (100) includes a low-voltage power supply and monitoring module (110), a high-voltage energy storage capacitor module (120), and a high-voltage charging and discharging module (130) arranged sequentially and fixed on the restraint strap (301). The low-voltage power supply and monitoring module (110) is equipped with an attitude sensor information processing module, which is used to collect motion state signals and human posture in real time. The low-voltage power supply and monitoring module (110) is used to supply power to the high-voltage energy storage capacitor module (120) and the high-voltage charge and discharge module (130), and to control the high-voltage energy storage capacitor module (120) to discharge and defibrillate through the high-voltage charge and discharge module (130); the high-voltage charge and discharge module (130) is used to convert the low-voltage electricity from the low-voltage power supply and monitoring module (110) into high-voltage electricity and store it in the high-voltage energy storage capacitor module (120). The defibrillation electrode (200) includes an LL defibrillation electrode (210) and an RA defibrillation electrode (220) with the same structure, both of which are electrically connected to the high-voltage charge-discharge module (130) and used for defibrillation. The defibrillation electrode (200) integrates an optical pulse wave sensor and a digital heart sound sensor.

2. The flexible strap-type wearable external defibrillator according to claim 1, characterized in that, The integrated defibrillator host (100) also includes a strip-shaped flexible shell structure. The low-voltage power supply and monitoring module (110), the high-voltage energy storage capacitor module (120) and the high-voltage charging and discharging module (130) are arranged in sequence and embedded in the strip-shaped flexible shell structure. The strip-shaped flexible shell structure is fixed on the restraint strap (301). The high-voltage energy storage capacitor module (120) includes six to eight electrically connected capacitor sub-modules (121). The capacitor sub-modules (121) are connected and fixed with flexible insulating material and embedded in the strip flexible shell structure. The capacitor sub-modules (121) are formed by stacking several thin-film capacitors.

3. The flexible strap-type wearable external defibrillator according to claim 2, characterized in that, The low-voltage power supply and monitoring module (110) includes: a status indicator and keypad (111), a removable battery module (112), a normally open power supply module (113), a power supply module that can be turned off (114), a main control microcontroller monitoring module (115), and a sensor information processing module (116), wherein the attitude sensor information processing module is arranged in the sensor information processing module (116); The detachable battery module (112) is electrically connected to the normally open power supply module (113) and the power-off module (114). The normally open power supply module (113) is electrically connected to the main control microcontroller monitoring module (115), the status indicator and keypad (111), and the sensor information processing module (116). The main control microcontroller monitoring module (115) is connected to the status indicator and keypad (111), the sensor information processing module (116), the power-off module (114), and the high-voltage charging and discharging module (130). The main control microcontroller monitoring module (115) and the sensor information processing module (116) are bidirectionally connected.

4. The flexible strap-type wearable external defibrillator according to claim 3, characterized in that, The high-voltage charging and discharging module (130) includes a high-voltage charging drive module (131), a high-voltage charging conversion module (132), a high-voltage charging and discharging voltage and current monitoring module (133), a high-voltage discharging H-bridge module (134), and a high-voltage discharging impedance control module (135). The main control microcontroller monitoring module (115) is connected to the high voltage charging drive module (131), the high voltage discharge H-bridge module (134), and the high voltage discharge impedance control module (135), respectively. The main control microcontroller monitoring module (115) and the high voltage discharge impedance control module (135) are bidirectionally connected. The power supply module (114) is connected to the high voltage charging drive module (131). The high voltage charging drive module (131) is connected to the plurality of capacitor sub-modules (121) through the high voltage charging conversion module (132). The capacitor sub-modules (121) are connected to the high voltage discharge H-bridge module (134). The high voltage discharge H-bridge module (134) is connected to the high voltage discharge impedance control module (135). The high voltage discharge H-bridge module (134) is connected to the main control microcontroller monitoring module (115) through the high voltage charging and discharging voltage and current monitoring module (133). The high voltage discharge H-bridge module (134) is connected to two defibrillation electrodes (200), respectively.

5. The flexible strap-type wearable external defibrillator according to claim 3, characterized in that, The LL defibrillation electrode pad (210), the RA defibrillation electrode pad (220), the optical pulse wave sensor, and the digital heart sound sensor are all connected to the main control single-chip microcomputer monitoring module (115) through the sensor information processing module (116). The LL defibrillation electrode pad (210) and the RA defibrillation electrode pad (220) are also used to acquire transthoracic respiratory impedance and electrocardiogram signals and transmit them to the sensor information processing module (116). The optical pulse wave sensor is used to collect pulse signals and send them to the sensor information processing module (116). The digital heart sound sensor is used to collect heart sound signals and send them to the sensor information processing module (116). The sensor information processing module (116) transmits the acquired signal to the main control microcontroller monitoring module (115). The main control microcontroller monitoring module (115) is used to determine whether to initiate external defibrillation based on electrocardiogram signal, pulse signal, heart sound signal, and transthoracic breathing impedance. The transthoracic breathing impedance includes low-pressure impedance signal and high-pressure impedance model.

6. The flexible strap-type wearable external defibrillator according to claim 1, characterized in that, The restraint straps (301) and the back straps (302) are made of plastic or knitted fabric; The restraint strap (301) includes: An integrated host silicone bracket (310) is used to assemble the integrated defibrillator host (100). The right retractable fastening strap (320) and the left retractable fastening strap (330) are respectively detachably and fixedly connected to both ends of the integrated host silicone bracket (310). The right retractable fastening strap (320) and the left retractable fastening strap (330) are detachably connected by a connecting buckle (340). The integrated host silicone bracket (310) is connected to the right retractable fastening strap (320) and the left retractable fastening strap (330) via the back strap (302). The integrated host silicone bracket (310) has a host mounting cavity, and the integrated defibrillator host (100) is embedded in the host mounting cavity; Both the integrated host silicone bracket (310) and the integrated defibrillator host (100) are provided with magnetic attraction points. The magnetic attraction points on the integrated host silicone bracket (310) are located inside the host mounting cavity. After the integrated defibrillator host (100) is assembled in the host mounting cavity, the magnetic attraction points on the integrated host silicone bracket (310) and the magnetic attraction points on the integrated defibrillator host (100) correspond to each other.

7. The flexible strap-type wearable external defibrillator according to claim 6, characterized in that, The integrated host silicone bracket (310) is provided with a right shoulder strap buckle end (311) and a left shoulder strap buckle end (312). The right retractable fastening strap (320) is provided with a right shoulder strap buckle end (321). The left retractable fastening strap (330) is provided with a left shoulder strap buckle end (331). Both ends of the right shoulder strap (350) and the left shoulder strap (360) are provided with buckles. The right shoulder strap (350) is fixedly connected to the right shoulder strap buckle end (311) and the right shoulder strap buckle end (321) through the buckles at both ends. The left shoulder strap (360) is fixedly connected to the left shoulder strap buckle end (312) and the left shoulder strap buckle end (331) through the buckles at both ends. The connecting buckle (340) can be a hook-type buckle, Velcro, or insert belt buckle; The strip-shaped flexible outer shell structure is provided with air gaps; The integrated defibrillator main unit (100) is equipped with a snap-fit ​​connector, and both defibrillation electrodes (200) are connected to the snap-fit ​​connector via defibrillation cables (230). The snap-fit ​​connector is connected to the high-voltage charging and discharging module (130).

8. An external defibrillation method, based on the flexible strap-type wearable external defibrillator according to any one of claims 1 to 7, characterized in that, Includes the following steps: The integrated defibrillator unit (100) can be detachably worn on the wearer's waist using the back strap wearable assembly (300); The wearer's electrocardiogram signal, low voltage impedance signal and optical pulse wave signal are collected in real time, and the motion state signal and human posture are collected in real time using the posture sensor information processing module. The presence or absence of cardiac arrest is determined based on the electrocardiogram signal, the low-voltage impedance signal, the motion state signal, the human posture, and the optical pulse wave signal. If cardiac arrest is identified, further confirmation is made based on the heart sound signal, the transcutaneous optical pulse wave signal, and the respiratory wave in the low-voltage impedance signal. If cardiac arrest is confirmed, a warning will be issued. If a warning reminder termination signal is received by the wearer within a set time threshold, the warning reminder will be terminated. Otherwise, the high-voltage charging and discharging module (130) will convert the low-voltage electricity from the low-voltage power supply and monitoring module (110) into high-voltage electricity and store it in the high-voltage energy storage capacitor module (120). The low-voltage power supply and monitoring module (110) will control the high-voltage energy storage capacitor module (120) to perform defibrillation through the high-voltage charging and discharging module (130) and the two defibrillation electrodes (200).

9. The external defibrillation method according to claim 8, characterized in that, The high-voltage charging and discharging module (130) converts the low-voltage electricity from the low-voltage power supply and monitoring module (110) into high-voltage electricity and stores it in the high-voltage energy storage capacitor module (120). The low-voltage power supply and monitoring module (110) controls the high-voltage energy storage capacitor module (120) to perform discharge defibrillation through the high-voltage charging and discharging module (130) and the two defibrillation electrodes (200), including: During the first charge, the low-pressure impedance of the human body through the chest is measured using the dual-frequency method; during subsequent charges, the high-pressure impedance is obtained based on the voltage and current of the previous high-pressure discharge. If the difference between the high-pressure impedance and the low-pressure impedance is greater than a threshold, the high-pressure impedance is used as the human body impedance; otherwise, the low-pressure impedance is used as the human body impedance. Select the charging voltage from the preset charging voltage table based on the human body impedance; The high-voltage charging and discharging module (130) charges the low-voltage power supply and monitoring module (110) into the high-voltage energy storage capacitor module (120) according to the charging voltage. The low-voltage power supply and monitoring module (110) controls the high-voltage energy storage capacitor module (120) to perform discharge defibrillation through the high-voltage charging and discharging module (130) and the two defibrillation electrodes (200) based on the human body impedance and defibrillation energy, and according to the preset discharge waveform control data.

10. The external defibrillation method according to claim 9, characterized in that, The step of obtaining the high-voltage impedance based on the voltage and current of the previous high-voltage discharge includes: Within 100us to 150us before the start of high-voltage discharge, several sets of current and voltage values ​​are continuously collected through the two defibrillation electrodes (200). After averaging the current and voltage values, Ohm's law is used to calculate the total impedance of the high-voltage discharge circuit. The high-voltage impedance is obtained by subtracting the impedance of the LL defibrillator electrode (210), the impedance of the RA defibrillator electrode (220), and the impedance of the high-voltage discharge impedance control module (135) from the total impedance of the high-voltage discharge circuit.

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