CN117982800A - Wearable external defibrillator - Google Patents

Abstract

The invention discloses a wearable external defibrillator, wherein a host machine comprises a shell, the bottom of the shell is connected with a base, a cavity is formed in the shell, and each functional module of the full-automatic external defibrillator is placed; the chest electrode is connected with the host through a cable; the convex structure is arranged on the bottom surface of the base; the electrode glue is arranged on the surface of the convex structure; the convex structure comprises a sensing electrode, a defibrillation electrode and convex silica gel, and the base is made of flexible liquid silica gel; the conductive region glue and the non-conductive region glue of the electrode glue are silicon glue or silk fibroin hydrogel, wherein conductive ions are added in the conductive region glue. The invention not only realizes all functions of the full-automatic external defibrillator and also monitors the sticking state of the electrode slice, but also realizes the ventilation, moisture permeability and moisture preservation in the process of sticking the electrode gel and the main body to the skin for 15 days from the structural design, so that the electrode slice can not lose water due to long wearing time to reduce the conductivity in the wearing process.

Description

Wearable external defibrillator

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a wearable external defibrillator.

Background

The currently marketed wearable AEDs are all smart vests, specifically aimed at being used by cardiac arrest tendencies and patients ready to place an endocardial defibrillator. Certain wearing limitations exist in wearing WCDs, such as external defibrillators equipped with batteries to monitor electrocardiographs for 24 hours and output defibrillation currents are bulky and must be worn on the body or on the waist; the wearable vest containing defibrillation electrodes and electrocardio electrodes, which is convenient for timely defibrillation, must be worn next to the skin for 24 hours. The wearing WCD is uncomfortable to wear when the weather is hot; patient privacy may be exposed; and brings inconvenience to living. Based on the above drawbacks, this type of WCD is also difficult to popularize and therefore commonly used, adding to the high price.

In recent years, a WCD based on electrode slice mode has been developed and advanced by ELEMENT SCIENCE company in the united states (hereinafter abbreviated as ES), and the patent applied in china is: CN113559415A, CN108289611B, CN112839585A. But the company equipment is currently in clinical test stage and has not entered clinical application. The WCD equipment of the ES solves some pain points of the vest type wearable WCD, such as the high cardiac arrest recognition rate, the small volume is convenient for attaching to the body surface (the thickness is about 40-50mm, the width is about 100mm, the length is about 300 mm), the main machine is divided into four detachable independent modules, and the four modules are assembled on the electrode plates when in operation, so that the multifunctional vest type wearable WCD can be well adapted to the curvatures of different human bodies; the electrode plate also has physiological information detection capability except electrocardiosignals, the internal atmosphere of the electrode plate is of a multi-layer structure, and a plurality of areas of the surface atmosphere of the electrode plate have different functions; as well as other design features.

In order to avoid the problem that the equipment cannot be clinically used due to the fact that the electrode plates are red, swelling, itching and inflammation of the skin and the edge of the electrode plates are red, swelling and ulceration of the skin caused during wearing, the wearing of the electrode plates is difficult for a wearer, the electrode plates are designed by using multiple layers of materials, and the design scheme is complex; several hard modules of the therapeutic host are designed to solve the problem of electrode tab pull-out caused by human body movement during waist wearing and the complex combination structure of the electrode tab.

Disclosure of Invention

In order to overcome the problems in the prior art, the invention provides a wearable external defibrillator, so as to meet the long-term wearing requirement, namely, the requirement of wearing the external defibrillator closely to the skin for a long time without falling off and allergy, and simultaneously, ensuring the automatic diagnosis and defibrillation treatment of sudden cardiac arrest.

In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:

A wearable external defibrillator comprising:

The host comprises a shell, wherein the bottom of the shell is connected with a base, and a cavity is formed in the shell;

the chest electrode is connected with the host through a cable;

The protruding structure is arranged on the bottom surface of the base;

the electrode glue is arranged on the surface of the convex structure;

The convex structure comprises a host sensing electrode, a host defibrillation electrode and convex silica gel; the base is made of flexible liquid silica gel; the electrode glue comprises conductive area glue and non-conductive area glue, wherein the conductive area glue is arranged on the host sensing electrode and the host defibrillation electrode, and the non-conductive area glue is arranged on the raised silica gel; the conductive region glue and the non-conductive region glue are both silicon mucilage glue or silk fibroin hydrogel, wherein conductive ions are added in the conductive region glue; the shell is a plurality of block-shaped hard shells.

Optionally, the bump structure further includes a chest sensing electrode and a chest defibrillation electrode, where the chest sensing electrode and the chest defibrillation electrode are both disposed on a bottom surface of the chest electrode.

Optionally, the edge of the protruding structure is provided with a barb, and the barb is matched with the electrode glue.

Optionally, the barb is wedge-shaped.

Optionally, bandage draw-in grooves have been seted up at the both ends of host computer, install the bandage buckle in the bandage draw-in groove.

Optionally, a circuit board substrate is arranged at the bottom of the cavity, the circuit board substrate is made of flexible materials, and a battery module, a monitoring circuit, an auxiliary alarm circuit and a defibrillation treatment circuit are arranged on the circuit board substrate; the monitoring circuit includes: the system comprises a low-voltage power conversion module, a low-voltage functional circuit, a main control module, a loudspeaker, an environment MIC (MIC) and temperature and humidity sensor integrated module and a close-fitting sensor module; the auxiliary alarm circuit includes button and pilot lamp module and warning module, defibrillation treatment circuit includes: the device comprises a high-voltage capacitor module, a high-voltage charging driving and transformer module, a high-voltage discharging biphase bridge and driving module, a high-voltage discharging variable resistance module, a flexible lower shell bottom dot matrix electrode plate module and a chest electrode.

Optionally, the main machine defibrillation electrode and the chest defibrillation electrode are connected with the high-voltage discharge biphasic bridge and the internal circuit of the driving module, and the main machine sensing electrode and the chest sensing electrode are electrically connected with the low-voltage functional circuit and the main control module.

Optionally, the main machine sensing electrode and the chest sensing electrode are round, and the main machine defibrillation electrode, the chest defibrillation electrode and the raised silica gel are round-corner rectangles.

Optionally, the number of the host sensing electrodes is four, and the host sensing electrodes are respectively arranged at four corners of the base; the main machine defibrillation electrodes and the raised silica gel are arranged in three rows according to two rows of each group, and the two groups of main machine defibrillation electrodes are arranged in the center of the base and are internally connected together in a short circuit way; the two groups of raised silica gel are respectively arranged at two sides of the two groups of main machine defibrillation electrodes.

Optionally, a convex silica gel is arranged between the two main machine sensing electrodes along the short axis direction of the base; protruding strips are arranged between each group of protruding silica gel and an adjacent group of host defibrillation electrodes and between the two groups of host defibrillation electrodes.

Compared with the prior art, the invention has the following beneficial effects:

The wearable external defibrillator provided by the invention has the advantages that the main machine of defibrillation treatment and the defibrillation electrode sheet are designed together; and solves the technical problem of long-term wearing at the same time; the conductive part of the defibrillation electrode slice is a part of the defibrillation therapeutic main body, and a user only needs to replace electrode gel when wearing the defibrillation electrode slice, so that the use cost is greatly reduced. The invention adopts the combined structure design of the shell and the soft silica gel base, which not only protects the internal circuit, but also enables the whole equipment to be bent. The invention uses the metal electrode with the multi-lattice ventilation structure and the gap between the electrodes, thereby realizing reliable adhesion to the skin, output of defibrillation heavy current and state detection of the electrode plate, and realizing ventilation and moisture permeability of the electrode glue and the main body to the skin. The part contacted with the human body adopts a structural design with ventilation effect, and adopts silk fibroin gel materials which can be stuck on the skin of the human body for a long time; the adhesive can be applied to human skin for 7 days, and ideally, the adhesive time of human skin for 15 days can not cause allergy and toxic injury to human skin, and can not cause skin redness, inflammation and even ulceration caused by the air permeability and water permeability problems and friction problems generated by the large-area close adhesion of equipment to the surface of human skin, and the electrode plate can not cause conductivity reduction due to water loss caused by long wearing time in the wearing process, so that the adhesive has reliable electric conductivity under the condition of keeping the adhesive effect. Meanwhile, the sensing electrode is used as a physiological signal monitoring sensor and a high-current treatment electrode for defibrillation treatment, so that the number and the complex design of the strap-type electrocardio electrode plates are reduced, and the identification reliability of cardiac arrest is improved.

Further, the cardiac arrest monitoring circuit of the present invention acts as a patient monitor; the defibrillation treatment circuit acts as an AED. The device with larger volume in two hospitals is reduced and integrated into the wearable device with the volume accounting for two tenth of the original volume, the miniaturization and the highly integrated assembly and stacking process based on the flexible circuit substrate are creatively adopted, and the device has great pushing effect on technical innovation in the field of design, production and manufacturing of external defibrillation devices.

Furthermore, the small-volume structure and the internal wearing form of the external defibrillator have concealment, so that the wearing capacity and wearing comfort are improved, the daily life of a patient is facilitated, the privacy of the patient is protected, and the usability and popularity of the external defibrillator device are promoted.

Furthermore, the convex structure of the invention uses the wedge-shaped anti-falling structure to improve the adhesive force with the main body and prevent the electrode glue from falling off from the main body due to the movement of the human trunk.

Drawings

The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. In addition, the shapes, proportional sizes, and the like of the respective components in the drawings are merely illustrative for aiding in understanding the present invention, and are not particularly limited. In the drawings:

fig. 1 is a schematic diagram of a wearable external defibrillator host of the present invention;

fig. 2 is a diagram of the internal stack of a wearable external defibrillator host according to the present invention;

fig. 3 is a layout diagram of functional blocks of internal circuit of a main unit of the wearable external defibrillator according to the present invention;

fig. 4 is a functional block diagram of a wearable external defibrillator of the present invention;

FIG. 5 is a view showing the construction of the chest electrode of the present invention;

FIG. 6 is a graph showing the gel area distribution of the chest electrode of the present invention;

FIG. 7 is a diagram of the bottom electrode configuration of the host of the present invention;

FIG. 8 is a plot of the area of the electrode paste of the present invention;

FIG. 9 is a complete view of the device body and electrode paste of the present invention;

FIG. 10 is an anti-slip barb microstructure according to the present invention;

FIG. 11 is a schematic illustration of the wearing of the present invention;

FIG. 12 is a host reinforcing structure of the present invention;

FIG. 13 is a schematic view of another embodiment 1 of a bottom bump structure of a host according to the present invention;

FIG. 14 is a schematic view of another embodiment 2 of a bottom bump structure of a host according to the invention;

FIG. 15 is a schematic view of another embodiment 3 of the bottom bump structure of the host according to the invention;

FIG. 16 is a diagram of another embodiment 4 of a bottom bump structure of a host according to the invention;

fig. 17 shows another embodiment 5 of the bottom bump structure of the host according to the invention.

100 Parts of a host; 101. a chamber; 102. a housing; 103. a base; 1. a battery module; 2. a low-voltage power conversion module; 3. the low-voltage functional circuit and the main control module; 4. the system comprises a loudspeaker, an environment MIC and a temperature and humidity sensor integrated module; 5. a body-fitted sensor module; 6. a key and an indicator module; 7. a warning module; 8. a high voltage capacitor module; 9. a high voltage charging drive and transformer module; 10. a high voltage discharge biphase bridge and a driving module; 11. a high voltage discharge variable resistance module; 12. a circuit board substrate; 13. a dot matrix electrode plate module; 15. a socket; 200. a cable; 20. a chest electrode; 201. chest defibrillation electrodes; 202. a chest sensing electrode; 201G, chest defibrillation electrode gel; 202G, chest cardiac inductance electrode paste; 203G, chest anti-skin friction wings; 204G, chest non-conductive reinforcement glue; 31. electrode glue; 32. a bump structure; 320. a barb; 301. a host sensing electrode; 302. a mainframe defibrillation electrode; 303. protruding silica gel; 304. a heart sound hole; 301G, a main engine core inductance electrode adhesive; 302G, mainframe defibrillation electrode gel; 303G, host non-conductive reinforcement glue; 304H, heart sound holes; 305G, a host anti-skin friction wing; 401. a bandage clamping groove; 402. the bandage is buckled; 1001. a torso; 1002. a left arm; 1003. and a right arm.

Detailed Description

In order to make the technical solution of the present invention better understood by those skilled in the art, the technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, shall fall within the scope of the invention.

It will be understood that when an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

The present invention will be described in detail with reference to the accompanying drawings.

As shown in fig. 1 and 2, a wearable external defibrillator of the present invention includes a main unit 100 and a chest electrode 20, wherein the main unit 100 and the chest electrode 20 are connected by a cable 200. The bottom of the housing 102 is connected with a base 103, and a chamber 101 is arranged inside the housing 102.

The casing 102 is a plurality of block-shaped hard shells, specifically, the casing 102 is five separate hard plastic shells, and the design makes the main body of the main body 100 bendable to adapt to different curvatures of different human body trunks, and enables the shape of the wearable device to be changed along with the twisting and bending of the trunk when the human body moves, so that the wearable device can be kept to be clung to the surface of the body and not pulled out.

The base 103 and the shell 102 are bonded together by glue, and the shell 102 and the base 103 are connected in a sealing way. A circuit board substrate 12 is connected to the bottom of each of the chambers 101.

As shown in fig. 3, the bottom of the circuit board substrate 12 is connected with the top of the base 103, the bottom of the base 103 is provided with a bump structure 32, and the bump structure 32 includes a host sensing electrode 301, a host defibrillation electrode 302, and a bump silica gel 303. The host sensing electrode 301 is used for acquiring electrocardiograms and detecting whether a part is separated from the skin. The base 103 is made of flexible liquid silica gel, and the convex silica gel 303 is formed by integral silica gel die casting; the electrode glue 31 includes conductive region glue and non-conductive region glue, wherein the conductive region glue is disposed on the host sensing electrode 301 and the host defibrillation electrode 302, and the non-conductive region glue is disposed on the raised silica gel 303; the conductive region glue and the non-conductive region glue are both silicon mucilage glue or silk fibroin hydrogel, wherein conductive ions are added in the conductive region glue. The silicon mucilage glue or the silk fibroin hydrogel has excellent biocompatibility of no toxicity, no stimulation and no allergy under the condition of long-term contact with human bodies. When in use, the electrode glue 31 is covered on the main machine sensing electrode 301, the main machine defibrillation electrode 302 and the raised silica gel 303, and the other surface is attached to the skin of a human body, so that a physical gap is formed between the base 103 and the electrode glue 31 to realize the function of ventilation and moisture permeability.

When the flexible trunk is in bending and twisting actions, three separation forces exist between the host machine of the incompletely flexible structure and the skin: torsion force in the axial direction of the trunk, drawing force in the horizontal direction and drawing force in the vertical direction. These two directional forces can cause the electrode sheet to fall off. The shell 102 is made of hard plastic, the shell 102 and the lower base 103 with silica gel ensure that the internal electronic module is not deformed, and the flexible circuit board substrate 12 ensures that the host 100 can be bent, so that the device is suitable for patients with different body shapes and body curvatures; such a design eliminates the risk of detachment of the host and skin layers, and fulfills the long-term wearing requirement from the wearing aspect.

The bump height of the bump structure 32 is 1mm to 2mm. The raised structures 32 are capable of performing a function of air and moisture permeability.

As shown in fig. 5, the chest electrode 20 is made of a flexible silica gel material, a plurality of chest defibrillation electrodes 201 and chest sensing electrodes 202 are assembled on the flexible silica gel main body, and the back of the chest defibrillation electrodes 201 are connected together to form a lattice type defibrillation electrode; the plurality of chest sensing electrodes 202 each comprise a plurality of electrocardiograph electrodes and skin sensing electrodes; the outgoing lines of the defibrillation electrodes and the cardioelectric electrodes form the cable 200.

As shown in fig. 7, the main body sensing electrode 301 at the bottom of the main body is circular, and the main body defibrillation electrode 302 and the raised silicone 303 are rounded rectangular. The number of the main unit sensing electrodes 301 is four, and the main unit sensing electrodes 301 are insulated from each other, and the four main unit sensing electrodes 301 are respectively disposed at four corners of the base 103. The number of mainframe defibrillation electrodes 302 is twelve and are conductive to each other. The main machine defibrillation electrodes 302 and the raised silica gel 303 are arranged in three rows according to two rows and three columns of each group, the two groups of main machine defibrillation electrodes 302 are arranged at the center of the base 103, and the two groups of raised silica gel 303 are respectively arranged at two sides of the two groups of main machine defibrillation electrodes 302. A piece of raised silica gel 303 is arranged between the two main machine sensing electrodes 301 along the short axis direction of the pedestal 103; the provision of raised strips between each set of raised silicone gel 303 and an adjacent set of mainframe defibrillation electrodes 302, and between the two sets of mainframe defibrillation electrodes 302, can increase the attachment area and increase the adhesive capacity between the skin and mainframe 100.

Optionally, the arrangement mode of the main defibrillation electrode 302 and the raised silica gel 303 is three rows, four columns, four rows, five columns, or five rows.

Alternatively, the number of host sense electrodes 301 is four to twelve.

Alternatively, the arrangement of the protruding structures 32 on the base 103 is shown in fig. 13 to 17.

The chest electrode paste is shown in fig. 6 and is divided into four different areas on a plan view, including chest defibrillation electrode paste 201G, chest cardiac sensing electrode paste 202G, chest anti-skin friction wings 203G and chest non-conductive reinforcing paste 204G. Wherein the chest defibrillation electrode glue 201G is conductive glue and covers the dot matrix defibrillation metal electrode 201 of the chest; the chest electrocardiograph electrode paste 202G is also conductive paste, covering the three chest sensing electrodes 202; the chest non-conductive reinforcing glue 204G with the same size as the flexible silica gel base fills the area outside the conductive silica gel of the flexible silica gel base; outside the corresponding area of the flexible silica gel base, a circle of very thin breathable and moisture permeable PE film single-sided adhesive or non-woven fabric single-sided adhesive is used as the chest skin friction prevention protective wing 203G, so that friction caused by different elasticity and flexibility of the outer periphery of the chest electrode 20 and human biological tissues and water stains and sweat flowing into the electrode slices in daily activities of a human body are prevented, and the chest electrode 20 is prevented from falling off.

As shown in fig. 8, the waist electrode paste is also divided into four different areas in a plan view, wherein the main core sensing electrode paste 301G is also conductive paste and covers the four main sensing electrodes 301; the main machine defibrillation electrode glue 302G is conductive glue, and covers the main machine defibrillation electrode 302 serving as a dot matrix of the waist at the bottom of the main body of the device; the host non-conductive reinforcing glue 303G with the same size as the flexible silica gel base 103 fills the areas outside the host heart electrode glue 301G and the host defibrillation electrode glue 302G of the flexible silica gel base; outside the corresponding area of the flexible silica gel base, a circle of thin breathable and moisture permeable PE film single-sided adhesive or non-woven fabric single-sided adhesive is used as a main machine anti-skin friction protective wing 305G, so that friction caused by different elasticity and flexibility of the edge of the main machine base 103 and human biological tissues in daily activities of a human body is prevented, and the main machine 100 and the electrode adhesive 31 or the electrode adhesive 31 and the skin are prevented from falling off due to the fact that the main machine base is not protected from causing skin inflammation and water stains and sweat flow into the electrode adhesive 31 to cause performance change of the electrode adhesive 31. In addition, the electrode gel 31 at the waist is provided with a heart sound hole 304H with the diameter of 5-8 mm, which corresponds to the heart sound hole 304 at the bottom of the main machine, and is used for providing a signal channel of heart sound and optical/pressure pulse wave for the close-fitting sensor module 5.

As shown in fig. 10, the edge of the protrusion 32 has a barb 320, and the barb 320 is matched with the electrode paste 31. Specifically, the barbs 320 are wedge-shaped extending outwardly. The barbs 320 function as a hanging glue to prevent the electrode glue 31 from being separated from the bump structure 32.

As shown in fig. 11, the main unit 100 is disposed on the left side of the trunk 1001, so as to prevent the main unit 100 from falling off due to unavoidable needs or reasons, such as long-time activity or temporary sweating and shower, when the main unit is worn for a long time, the two ends of the housing 102 of the main unit 100 are provided with bandage clamping grooves 401, and the bandage clamping grooves 401 are provided with bandage buckles 402.

The wearer ties the main unit 100 to the waist of the wearer by fastening the straps at both ends using a stretchable velcro strap or a bandage with a buckle.

As shown in fig. 3, in the chamber 101, a battery module 1, a monitoring circuit, an auxiliary alarm circuit, and a defibrillation treatment circuit are disposed on top of the circuit board substrate 12.

The battery module 1 is four disposable CR123A batteries or a piece of size-customized polymer rechargeable lithium battery, and the output capacity is 6V and 3A. Power is provided to the cardiac arrest monitoring circuit and the defibrillation therapy circuit.

The monitoring circuit includes: the low-voltage power conversion module 2, the low-voltage functional circuit, the main control module 3 and the close-fitting sensor module 5; the auxiliary alarm circuit comprises a key, an indicator lamp module 6, a loudspeaker, an environment MIC, a temperature and humidity sensor integrated module 4 and an alarm module 7.

The main function of the low-voltage power conversion module 2 is to convert the battery voltage of 6V into digital power supplies 3.3VDD, 5VDD and analog power supplies 3.3VA and 5VA used by other monitoring circuits; the low-voltage functional circuit and the main control module 3 use digital 3.3VDD and analog 3.3VA; the speaker, environment MIC and temperature and humidity sensor integrated module 4 uses analog power supplies 3.3VA and 5VA and digital power supply 3.3VDD; the on-body sensor module 5 uses digital 3.3VDD and analog 3.3VA, 5VA; the key and indicator module 6 uses a digital power supply 3.3VDD; the alert module 7 uses the numbers 3.3VDD and 5VDD.

The low-voltage functional circuit and the main control module 3 play a main control role of the whole system, the circuit module is a multifunctional embedded software and hardware system, and the peripheral functional circuit of the embedded system is used for realizing signal conditioning and digitalization of multipath analog physiological signals of electrocardio, respiration, heart sound and optical pulse wave, recognition analysis and diagnosis of sudden cardiac arrest events, time sequence and logic control of first-aid processes and physiological waveform storage of electrocardio/respiration/heart sound/pressure or optical pulse wave for at least 30 minutes; in addition, the life state of the patient is judged and stored through signals output by the triaxial acceleration sensor: walking, exercise, resting, sleeping, and unexpected falls. The main machine defibrillation electrode 302 and the chest defibrillation electrode 201 are connected with the high-voltage discharge biphasic bridge and the internal circuit of the driving module 10 to finish defibrillation discharge on a human body, and the main machine sensing electrode 301 and the chest sensing electrode 202 are electrically connected with the low-voltage functional circuit and the main control module 3 to realize processing and acquisition of electrocardiosignals and respiratory wave signals.

The loudspeaker, the environment MIC and the temperature and humidity sensor integrated module 4 are used for providing various alarms or warnings of sudden cardiac arrest in a voice broadcasting mode, and the MIC is used for collecting environment sounds and evaluating the emergency treatment process after the sudden cardiac arrest; the temperature and humidity sensor is used for measuring the temperature and humidity of the equipment shell outside the skin, is used for assisting in judging the environment state of a wearer, and is combined with the temperature and humidity sensor inside the close-fitting sensor module 5 at the skin to monitor the internal environment of the defibrillation electrode adhesive. The loudspeaker, the environment MIC and the temperature and humidity sensor integrated module 4 also have a wireless communication function, and can transmit the rescue after the cardiac arrest and the real-time physiological signals of the patient to the terminal of a guardian or a remote monitoring and emergency treatment center through Bluetooth/WIFI or a wireless communication network module.

The close-fitting sensor module 5 is provided with a heart sound sensor/an optical pulse wave sensor/a body surface temperature and humidity sensor, heart sounds and optical pulse waves of a human body can be stored and collected close to the skin of the human body, the heart sounds and the optical pulse waves are the most direct evidence except for electrocardiosignals for judging cardiac arrest, and the heart sounds and the optical pulse waves are combined with the electrocardiosignals to identify and diagnose ventricular flutter or pulse-free ventricular tachycardia, so that 100% of patients can be diagnosed to be in a cardiac arrest state, and misdiagnosis caused by the acquisition errors of electrocardiograms or the occurrence of interference and noise is reduced or eliminated. The body surface temperature and humidity sensor detects the temperature and humidity of the skin and is used for judging the skin environment inside the electrode sheet in a good adhesion state, and the sensor is arranged in the middle of the bottom of the main body and avoids the conductive part of the defibrillation electrode.

The key and indicator light module 6 is used for interaction during wearing. A button in the host wear for providing the user with an option to confirm that defibrillation is to be performed when sudden cardiac arrest is detected; the method is used for confirming that all functions of wearing well run normally when the host wears and checks, and comprises the steps of whether a host sensing electrode 301 and a host defibrillation electrode 302 are well adhered, have no edge curling and bulge or are virtually adhered; detecting whether electrocardiosignals, respiratory signals, heartbeat sounds, pressure or optical pulse waves are normal or not and whether the internal charge and discharge functions are normal or not; the indicator lights are used for status display and feedback on patient or healthcare worker operation.

The alarm module 7 is used for reminding the wearer of danger in another way besides hearing when the sudden cardiac arrest event is detected by taking the attention of the wearer through touch in a vibration way, and is in an emergency state.

The defibrillation treatment circuit includes: a high-voltage capacitor module 8, a high-voltage charging driving and transformer module 9, a high-voltage discharging biphase bridge and driving module 10, a high-voltage discharging variable resistance module 11, a lattice electrode plate module 13 arranged on a base 103, and a chest electrode 20.

The high-voltage capacitor module 8 comprises five capacitors connected in series, each capacitor is arranged in one cavity 101, each capacitor has a capacity of 560uF, and each capacitor is columnar and can resist 400V voltage. The high-voltage capacitor module 8 is used for high-voltage discharging of the energy storage capacitor; there is a gap between the five discrete capacitors to facilitate bending.

The high voltage charging drive and transformer module 9 comprises a high voltage charging drive module and a transformer module. The high-voltage charging driving module can charge the high-voltage capacitor module 8 to 2000V in 30 to 40 seconds by using the 6V power supply provided by the battery module 1; the high-voltage charging driving module uses a variable PWM wave to control a switching tube to release and charge magnetic energy of the transformer module, and charges the high-voltage capacitor module 8 through a rectifying circuit.

The high-voltage discharge biphase bridge and driving module 10 opens four high-voltage electronic bridge switches through mutually exclusive interaction after being driven by a pulse voltage device by discharge control pulse, so as to realize biphase discharge current. The high-voltage discharge biphasic bridge and driving module 10 is electrically connected with the waist main machine defibrillation electrode 302 at the bottom of the main machine and the cable 200, and forms a closed loop circuit for discharging the main machine to the defibrillation treatment of the human body after being conducted with the skin of the human body through electrode glue.

As shown in fig. 7, the high-voltage discharge dual-phase bridge and driving module 10 is provided with a socket 15 on the housing of the chamber 101 for installing the cable 200.

The high-voltage discharge variable resistance module 11 is connected in series with the high-voltage discharge biphasic bridge and driving module 10 and the human body current output, and dynamically adjusts the biphasic discharge current of the whole defibrillation treatment circuit to compensate the current drop caused by the voltage drop on the high-voltage capacitor in the discharge process, thereby obtaining the horizontal discharge current of the first phase. The control of the high-voltage discharge variable resistance module 11 can realize the biphasic square wave defibrillation current applied on the human body.

Specifically, as shown in fig. 3, the high-voltage charging driving and transformer module 9, the key and indicator lamp module 6, the speaker, the environmental MIC and temperature and humidity sensor integrated module 4, the low-voltage power conversion module 2 and the low-voltage functional circuit are disposed in the same chamber 101 as the main control module 3; the high-voltage discharge two-phase bridge and the driving module 10 and the high-voltage discharge variable resistance module 11 are disposed in the same chamber 101.

The circuit board substrate 12 is a circuit board substrate penetrating through the main structure, and achieves the functions of a system bus, and the battery module 1, the warning module 7, the five high-voltage capacitor modules 8, the high-voltage discharge variable resistance module 11, the high-voltage discharge biphase bridge and driving module 10, the high-voltage charging driving and transformer module 9, the low-voltage power conversion module 2, the low-voltage functional circuit and main control module 3, the loudspeaker, the environment MIC and temperature and humidity sensor integrated module 4, the close-fitting sensor module 5, the key and indicator lamp module 6 and the dot matrix electrode plate module 13 are connected in series, and are welded on the module directly or by using connectors. The circuit board substrate 12 reduces direct connection wires among different modules, plays a role in reducing weight and wire number, and is convenient for production and manufacture.

The defibrillation current flows out from the positive electrode of the high-voltage capacitor module 8, enters the high-voltage discharge biphasic bridge and driving module 10, flows into the human body from the dot matrix electrode plate module 13 after being switched by the bridge circuit, flows out from the chest electrode 20 of the human body of the patient after passing through the heart, flows into the high-voltage discharge variable resistance module 11 and flows back to the negative electrode of the high-voltage capacitor module 8, so that a defibrillation discharge loop is formed; in particular, the high-voltage discharge biphasic bridge and driving module 10 can switch the current entering the human body from the chest electrode 20 to enter the human body, flow through the heart and then flow out from the dot matrix electrode plate module 13 at the waist, enter the inside of the device, and then enter the high-voltage discharge variable resistance module 11, so that the reverse defibrillation current is formed in the inside of the human body.

The plurality of circuit modules form the complete function of the full-automatic external defibrillator. The functional block diagram and control relationships for the cooperation between the various modules are shown in fig. 4.

After the wearable external defibrillator is worn and stuck on the skin surface of a human body, the monitoring circuit of the whole system enters a working state, and the defibrillation treatment circuit is in a closing state. The detailed working steps of the monitoring circuit are as follows:

The low-voltage functional circuit and the embedded controller in the main control module 3 are configured with an internal integrated electrocardiosignal front-end processing unit to start working, 8-10 electrocardiosignals are extracted from a plurality of host sensing electrodes 301 in the dot matrix electrode plate module 13 of the waist electrode and a plurality of sensing electrodes 202 of the chest electrode 20, and after synthesis by using 1-2 channels without electrode falling, whether the electrocardiosignals are defibrillation heart rhythm (ventricular fibrillation and pulse-free ventricular velocity) is judged through an electrocardiosignal identification algorithm, so that whether sudden cardiac arrest occurs is primarily diagnosed;

After the electrocardiosignals are collected, the embedded controller also judges whether a plurality of electrocardiosignals are in a lead falling state or not, so as to judge whether the area of the human skin and the chest sensing electrode has electric connection failure, wherein the connection failure is generally represented by the separation of the electrode gel and the human skin or the separation of the electrode gel and the metal chest sensing electrode; if the electric connection fails, reminding a wearer to compact and strengthen the electrode adhesive separation part, and recovering the good electric connection state of the electrode adhesive, the skin and the bottom of the host; similarly, the plurality of host sensing electrodes 301 attached to the waist portion of the chassis 103 are also part of the electrocardiographic sensing electrodes, and the electrocardiographic leads formed by the respective sensing electrodes, and if the leads are detected to fall off, this also indicates that the signal transmission between the host sensing electrodes 301 on the chassis and the host electrocardiographic sensing electrode paste 301G and the skin is problematic, which may be caused by the electrode paste falling off the sensing electrodes or falling off the skin. The wearer is required to be reminded of compacting and reinforcing the electrode paste detachment site and to restore the good electrical connection state of the electrode paste with the skin and the bottom of the host.

The embedded controller reads the chest respiratory impedance change signal and is used for evaluating respiratory capacity and state while reading the electrocardio; the long-time cardiac arrest state can cause the patient to lose consciousness and breathing, is unfavorable for the recovery of the patient, belongs to a very critical emergency state, and needs other aspects of assistance to assist the cardioversion of the patient;

The embedded controller is also configured with a sensor in the close-fitting sensor module 5 to start working, and reads heart sound signals and pulse wave signals of peripheral blood vessels; the main characteristic of the occurrence of sudden cardiac arrest is that the heart of the heart cannot pump blood out to the aorta and the pulmonary veins, so that besides the electrocardiosignal is in ventricular fibrillation or no-pulse ventricular tachycardia, the first heart sound and the second heart sound of the normal heart are absent or disappear, the pulse wave characteristic without blood flow fluctuation in the body surface blood vessel is most obvious confirmation, and the breathing loses the ventilation effect of oxygen and carbon dioxide. If analysis and identification errors are caused by failure of electrocardiosignal extraction or electrocardiosignal noise, heart sound deficiency and disappearance of body surface pulse waves are used, so that the occurrence of sudden cardiac arrest can be diagnosed; or the analysis and identification of the electrocardiosignal are caused by the interference and noise of the electrocardiosignal, and the ventricular fibrillation or ventricular velocity is generated, but the heart sound and the body surface vascular pulse wave which are more normal can be detected, and the diagnosis of no need of defibrillation treatment can be carried out.

The low-voltage functional circuit and an embedded controller in the main control module 3 execute a comprehensive analysis and identification algorithm of cardiac arrest of electrocardio, heart sound and peripheral pulse wave signals, and the embedded controller diagnoses that the wearer is in a cardiac arrest state, and the embedded controller carries out warning prompt of different degrees for a plurality of times through a loudspeaker, an environment MIC and a vibration motor in the temperature and humidity sensor integrated module 4 and the loudspeaker and the close-fitting sensor module 5 within about one minute so as to remind the wearer of cardiac arrest events; and flashes the key and indicator light provided in the indicator light module 6.

If the wearer considers that the diagnosis is wrong, simultaneously pressing the keys and two keys in the indicator light module 6 in the time window of the voice prompt to tell the embedded controller that the discharge treatment is not needed; if the wearer cannot correctly judge that the condition of the wearer is not timely pressed for cancellation because of the discomfort of sudden cardiac arrest, the defibrillation treatment circuit is electrified, and the flow of defibrillation treatment is started.

The defibrillation treatment process comprises the steps that firstly, an embedded controller charges a high-voltage capacitor module 8 through a high-voltage charging drive and transformer module 9, and after the high-voltage capacitor module is charged to energy capable of discharging 120 joules outside, the charging is stopped;

The embedded controller then controls the high voltage discharge biphasic bridge and drive module 10 to begin outputting the first phase of the biphasic wave. Defibrillation current flows from the positive electrode of the high-voltage capacitor module, drives and opens one ends of two crossed bridge arms on the high-voltage discharge biphasic bridge through the embedded controller, enters a human body through a main machine defibrillation electrode 302 at the bottom of the main body of the lumbar defibrillator, flows back into the defibrillator from a chest defibrillation electrode 201 of the chest after flowing through the heart, and flows back to the negative electrode of the high-voltage capacitor module 8 through the other ends of the two crossed bridge arms on the high-voltage discharge biphasic bridge through the high-voltage discharge variable resistance module 11. Calculating the human body discharge impedance of the patient by detecting the discharge current and the voltage for a plurality of times within 150us before the first phase starts; after 150us, according to the measured human body discharge impedance, a preset internal compensation impedance control sequence is selected, the resistance value is changed at 5-2 equal intervals within 6ms, dynamic discharge impedance matching is carried out, the aim of synchronously reducing the total discharge loop impedance of the discharge voltage is fulfilled, and accordingly, the approximately direct-current discharge current is formed within 6ms of the first phase.

After the 6ms discharge of the first phase is completed, the high-voltage discharge biphasic bridge and the internal bridge of the driving module 10 are completely closed by about 200us, and the discharge is stopped;

The embedded controller then controls the opening of the other pair of intersecting legs in the high voltage discharge biphasic bridge and drive module 10 to begin the second phase discharge of the biphasic defibrillation. At this time, the current flowing from the positive electrode of the high-voltage charging capacitor flows into the human body from the chest defibrillation electrode 201 of the chest through one end of the opened intersecting bridge arm, and the reverse current flowing through the human body flows out of the human body from the main defibrillation electrode 302 at the bottom of the lumbar defibrillator main body after flowing through the heart again, and flows back through the high-voltage discharge variable resistance module 11 through the other end of the opened intersecting bridge arm. The embedded controller controls the opening time of the other pair of intersecting bridge arms in the high voltage discharge biphasic bridge and drive module 10 to be 4ms. During this time, the resistance of the high-voltage discharge variable resistance module 11 is not changed and is set to a predetermined constant resistance value.

After the 4ms reverse current discharge is completed, one cycle of the whole 10ms defibrillation treatment is ended;

The embedded controller, upon entering the cardiac arrest monitoring state, as in step 1, repeats steps 1-8, and if the identification diagnosis is still in the cardiac arrest state, initiates a second warning and 150 joules defibrillation therapy. The second time is still the first phase positive phase direct current defibrillation discharge of 6ms, stop 200us, and then carry on the reverse phase current defibrillation discharge of 4 ms;

the following cycles were followed by 1-8 monitoring and treatment steps, with defibrillation energy being used for 150 joules.

If the treatment is successful, the monitoring state is always in;

Once the occurrence of sudden cardiac arrest is detected, the embedded controller also opens the loudspeaker, the environment MIC and the wireless communication module in the temperature and humidity sensor integrated module 4, and transmits physiological signals before and after the sudden cardiac arrest to a remote guardian and an emergency center through Bluetooth, WIFI or a wireless communication network.

The device elements in the above embodiments are conventional device elements unless otherwise specified, and the structural arrangement, operation or control modes in the embodiments are conventional arrangement, operation or control modes in the art unless otherwise specified.

Finally, it is noted that the above-mentioned embodiments are merely for illustrating the technical solution of the present invention, and that other modifications and equivalents thereof by those skilled in the art should be included in the scope of the claims of the present invention without departing from the spirit and scope of the technical solution of the present invention.

Claims (10)

1. A wearable external defibrillator comprising:

The host machine (100), the host machine (100) comprises a shell (102), a base (103) is connected to the bottom of the shell (102), and a cavity (101) is formed in the shell (102);

a chest electrode (20), the chest electrode (20) being connected to the main machine (100) by a cable (200);

A protruding structure (32), wherein the protruding structure (32) is arranged on the bottom surface of the base (103);

an electrode paste (31), the electrode paste (31) being disposed on a surface of the bump structure (32);

Wherein the raised structure (32) comprises a host sensing electrode (301), a host defibrillation electrode (302) and raised silica gel (303); the base (103) is made of flexible liquid silica gel; the electrode glue (31) comprises conductive area glue and non-conductive area glue, wherein the conductive area glue is arranged on the host sensing electrode (301) and the host defibrillation electrode (302), and the non-conductive area glue is arranged on the raised silica gel (303); the conductive region glue and the non-conductive region glue are both silicon mucilage glue or silk fibroin hydrogel, wherein conductive ions are added in the conductive region glue; the shell (102) is a plurality of block-shaped hard shells.

2. The wearable external defibrillator of claim 1, wherein the bump structure (32) further comprises a chest sensing electrode (202) and a chest defibrillation electrode (201), the chest sensing electrode (202) and chest defibrillation electrode (201) being disposed on a bottom surface of the chest electrode (20).

3. The wearable external defibrillator according to claim 1, wherein the edge of the protruding structure (32) has barbs (320), the barbs (320) cooperating with the electrode gel (31).

4. A wearable external defibrillator according to claim 3, wherein the barbs (320) are wedge-shaped.

5. The wearable external defibrillator according to claim 1, wherein bandage clamping grooves (401) are formed in two ends of the main machine (100), and bandage buckles (402) are arranged in the bandage clamping grooves (401).

6. The wearable external defibrillator according to claim 1, wherein a circuit board substrate (12) is arranged at the bottom of the chamber (101), the circuit board substrate (12) is made of flexible materials, and a battery module (1), a monitoring circuit, an auxiliary alarm circuit and a defibrillation treatment circuit are arranged on the circuit board substrate (12); the monitoring circuit includes: the system comprises a low-voltage power conversion module (2), a low-voltage functional circuit and main control module (3), a loudspeaker, an environment MIC and temperature and humidity sensor integrated module (4) and a close-fitting sensor module (5); the auxiliary alarm circuit comprises a key, an indicator lamp module (6) and a warning module (7), and the defibrillation treatment circuit comprises: the high-voltage capacitor module (8), the high-voltage charging driving and transformer module (9), the high-voltage discharging biphase bridge and driving module (10), the high-voltage discharging variable resistance module (11), the flexible lower shell bottom dot matrix electrode plate module (13) and the chest electrode (20).

7. The wearable external defibrillator according to claim 6, wherein the main machine defibrillation electrode (302) and the chest defibrillation electrode (201) are connected with the high-voltage discharge biphasic bridge and the internal circuit of the driving module (10), and the main machine sensing electrode (301) and the chest sensing electrode (202) are electrically connected with the low-voltage functional circuit and the main control module (3).

8. The wearable external defibrillator of claim 1, wherein the main machine sensing electrode (301) and the chest sensing electrode (202) are circular, and the main machine defibrillation electrode (302), the chest defibrillation electrode (201) and the raised silicone (303) are rounded rectangles.

9. The wearable external defibrillator according to claim 1, wherein the number of the main body sensing electrodes (301) is four, and the main body sensing electrodes are respectively arranged at four corners of the base (103); the main machine defibrillation electrodes (302) and the raised silica gel (303) are arranged in each group of two columns and three rows, and the two groups of main machine defibrillation electrodes (302) are arranged in the center of the base (103) and are internally connected in a short circuit manner; two groups of raised silica gel (303) are respectively arranged at two sides of the two groups of main machine defibrillation electrodes (302).

10. The wearable external defibrillator according to claim 9, wherein a raised silica gel (303) is provided between two main body sensing electrodes (301) along the short axis direction of the base (103); protruding strips (305) are arranged between each group of protruding silica gel (303) and an adjacent group of host defibrillation electrodes (302) and between the two groups of host defibrillation electrodes (302).