Wearable external defibrillator and control method

Abstract

The invention belongs to the technical field of defibrillators, and discloses a wearable external defibrillator and a control method, a defibrillation electrode comprises an electrode base and a detachable long-acting defibrillation electrode slice, and the one-time pasting use time of the electrode slice is 7-15 days. Wherein the integrated host is used for mounting an LL defibrillation electrode slice by virtue of a base; a detachable RA defibrillation electrode plate is hung on the RA defibrillation electrode base; and the RA defibrillation electrode base is connected to the integrated host through the RA defibrillation electrode cable. The LL defibrillation electrode and the RA defibrillation electrode are both provided with a plurality of sub-electrode units, and each sub-electrode unit is composed of a metal female buckle fixed to the base, a metal male buckle fixed to the electrode slice and conductive gel. The integrated host collects electrocardio and vital sign parameters of a wearer in real time through the LL defibrillation electrode and the RA defibrillation electrode, monitors whether sudden cardiac arrest happens to a patient or not, and conducts defibrillation discharge treatment on the wearer through the LL defibrillation electrode and the RA defibrillation electrode when it is confirmed that sudden cardiac arrest happens.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a wearable external defibrillator and a control method. BACKGROUND

[0002] Cardiac arrest is the main cause of patient sudden cardiac death (SCD, Sudden Cardiac Death), and defibrillation shock treatment is the most effective technical means to save the patient's life.

[0003] The defibrillation treatment devices on the market can be divided into three types according to the timeliness of treatment: implantable cardioverter defibrillator (ICD, implantable cardioverter defibrillator), wearable external defibrillator (WCD, wearable cardioverter defibrillator), and automated external defibrillator (AED).

[0004] The core function of the wearable WCD is to continuously monitor the human electrocardiogram during wearing, and to provide timely defibrillation treatment when cardiac arrest occurs. The key implementation path of monitoring human physiological signals and defibrillation treatment requires the defibrillator to collect human electrocardiogram signals through defibrillation electrodes or electrocardiogram electrodes, and to collect other available physiological signals for monitoring. When the wearer detects cardiac arrest, it can release a short strong current of 10-35 amperes and 100-200 joules to the human body to eliminate the cardiac arrest state and achieve the purpose of restoring normal cardiac physiological activity rhythm. This requires the defibrillation or electrocardiogram electrode patch of the WCD to be in good contact with the human skin at all times and to be able to collect accurate human physiological signals.

[0005] Among the several WCDs that have obtained registration certificates globally, three are chest type and one is patch type. The chest type WCD only has a metal electrode at the waist that is in close contact with the human body to collect human electrocardiogram signals; the patch type WCD relies on one or two pieces of adhesive electrode patch to be pasted on the external defibrillation part for a long time, and the monitoring and defibrillation device is fixed on the electrode patch; the adhesive time of the detachable and replaceable electrode patch can reach 7-201 days. Compared with the chest type WCD, the patch type WCD has better wear adaptability.

[0006] The patent applications with Chinese patent numbers CN112839585A, CN108289611A, CN113559415A, and CN106456984A all mention a detachable monitoring and defibrillation treatment module, and a multi-layer composite WCD electrode sheet; the four detachable modules include an energy storage battery module, a physiological signal acquisition and monitoring module, and a high-voltage charging and discharging module, which are fixed on the multi-layer composite electrode sheet through the locking structure at the bottom of the module. The electrode sheet described in the product is an 8 to 9 layer composite electrode sheet, each layer has its own function to achieve the purpose of air permeability and moisture retention, long-term reliable adhesion to the patient's skin, and to bear the load and mount the main body of the WCD, the battery, the monitoring and defibrillation module. The detachable electrode sheet of this WCD has a complex mechanical device and composite material inside, which has the disadvantages of complex design process and production processing, high cost, and heavy weight.

[0007] The patent application with Chinese patent number CN117982800A provides another product implementation scheme for a patch type WCD. The WCD described in this patent application is composed of a replaceable pure gel electrode sheet and an integrated wearable WCD host. The LL (Left Leg, left lower, at the junction of the left midclavicular line and the 5th intercostal space) and RA (Right Arm, right upper, at the junction of the right midclavicular line and the 2nd intercostal space) electrode sheet structure of this patent application is simple, but there are reliability shortcomings of separation between the integrated host, the electrode sheet, and the human skin when worn, and air permeability and moisture retention, and high adhesion requirements for the electrode gel that constitutes the electrode sheet. In addition, there is a certain difficulty in the adhesion of the flexible electrode sheet and the position matching of the host when worn, and there is also a processing difficulty in the conductive and insulating parts of the electrode sheet. SUMMARY

[0008] In order to overcome the problems existing in the prior art, the present application provides a patch wearable external defibrillator based on a detachable electrode sheet and a control method. The system uses mature electrode processing technology and conductive adhesive material and skin adhesive material, through innovative structure design and layout design suitable for WCD clinical application, so that the defibrillation electrode sheet used in this form of WCD has sufficient skin adhesion through the setting of conductive gel, and can be connected through metal male and female buckles, which can bear the weight of the integrated host of the WCD, and also has good air permeability and moisture retention performance, ensuring the application requirements of the patch type WCD for long-term wear of 7 to 201 days.

[0009] To achieve the above object, the technical scheme adopted by the present application is: In a first aspect, the present application provides a wearable defibrillator, comprising: an integrated main machine, a LL defibrillation electrode and a RA defibrillation electrode; the LL defibrillation electrode comprises a detachable LL defibrillation electrode sheet and a base connected to each other through a first metal male-female buckle structure; the RA defibrillation electrode comprises a RA defibrillation electrode base and a detachable RA defibrillation electrode sheet connected to each other through a second metal male-female buckle structure; the base and the RA defibrillation electrode base are both electrically connected to the integrated main machine; in the first metal male-female buckle structure, the metal male buckle or the metal female buckle outside the detachable LL defibrillation electrode sheet, and in the second metal male-female buckle structure, the metal male buckle or the metal female buckle outside the detachable RA defibrillation electrode sheet, are respectively provided with a first conductive gel and a second conductive gel; the wearable defibrillation system is packaged in the integrated main machine, and is used to control the LL defibrillation electrode and the RA defibrillation electrode to work.

[0010] Optionally, the bottom of the base has a first metal female buckle; the detachable LL defibrillation electrode sheet has a plurality of first metal male buckles matched with the first metal female buckle; the RA defibrillation electrode base has a second metal female buckle; the detachable RA defibrillation electrode sheet has a plurality of second metal male buckles matched with the second metal female buckle; the first metal female buckle comprises a first defibrillation sub-electrode female buckle and a first cardiac electronic electrode female buckle; the second metal female buckle comprises a second defibrillation sub-electrode female buckle and a second cardiac electronic electrode female buckle; the first metal male buckle comprises a first defibrillation sub-electrode male buckle corresponding to the position of the first defibrillation sub-electrode female buckle and a first cardiac electronic electrode male buckle corresponding to the position of the first cardiac electronic electrode female buckle; the first defibrillation sub-electrode male buckle and the first cardiac electronic electrode male buckle both have a first bottom buckle and a first male buckle surface buckle sleeved on the first bottom buckle; the second metal male buckle comprises a second defibrillation sub-electrode male buckle corresponding to the position of the second defibrillation sub-electrode female buckle and a second cardiac electronic electrode male buckle corresponding to the position of the second cardiac electronic electrode female buckle; the second defibrillation sub-electrode male buckle and the second cardiac electronic electrode male buckle both have a second bottom buckle and a second male buckle surface buckle sleeved on the second bottom buckle.

[0011] Optionally, a first waterproof moisturizing film, a first non-woven fabric layer and a first insulating adhesive layer are sequentially arranged between the first male buckle surface buckle and the first bottom buckle along the direction from the first male buckle surface buckle to the first bottom buckle; a second waterproof moisturizing film, a second non-woven fabric layer and a second insulating adhesive layer are sequentially arranged between the second male buckle surface buckle and the second bottom buckle along the direction from the second male buckle surface buckle to the second bottom buckle; the diameter of the first waterproof moisturizing film is greater than or equal to the diameter of the first conductive gel, and the diameter of the second waterproof moisturizing film is greater than or equal to the diameter of the second conductive gel; the projection of the first waterproof moisturizing film on the first non-woven fabric layer covers the projection of the first conductive gel on the first non-woven fabric layer; the projection of the second waterproof moisturizing film on the second non-woven fabric layer covers the projection of the second conductive gel on the second non-woven fabric layer.

[0012] Optionally, the first waterproof and moisturizing film includes a defibrillator first waterproof and moisturizing film and an electronic cardiology first waterproof and moisturizing film, wherein the defibrillator first waterproof and moisturizing film is sandwiched between the first male fastener and the first nonwoven fabric layer; the electronic cardiology first waterproof and moisturizing film is sandwiched between the first male fastener and the first nonwoven fabric layer; the second conductive gel includes a second defibrillator electrode conductive gel and a second electronic cardiology electrode conductive gel; the second defibrillator electrode conductive gel is disposed at the end of the second defibrillator electrode male fastener away from the second defibrillator electrode female fastener; the second electronic cardiology electrode conductive gel is disposed at the end of the second electronic cardiology electrode male fastener away from the second electronic cardiology electrode female fastener; the second waterproof and moisturizing film includes a defibrillator second waterproof and moisturizing film and an electronic cardiology second waterproof and moisturizing film, wherein the defibrillator second waterproof and moisturizing film is sandwiched between the second male fastener and the second nonwoven fabric layer; the electronic cardiology second waterproof and moisturizing film is sandwiched between the second male fastener and the second nonwoven fabric layer.

[0013] Optionally, the first conductive gel includes a first defibrillator electrode conductive gel and a first cardiac electrode conductive gel; the first defibrillator electrode conductive gel is disposed at the end of the first defibrillator electrode male buckle away from the first defibrillator electrode female buckle; the first cardiac electrode conductive gel is disposed at the end of the first cardiac electrode male buckle away from the first cardiac electrode female buckle; the projection of the first waterproof and moisturizing film of the defibrillator on the first non-woven fabric layer covers the projection of the first defibrillator electrode conductive gel on the first non-woven fabric layer; the projection of the first waterproof and moisturizing film of the cardiac electrode on the first non-woven fabric layer covers the projection of the first cardiac electrode conductive gel on the first non-woven fabric layer; the projection of the second waterproof and moisturizing film of the defibrillator on the second non-woven fabric layer covers the projection of the second defibrillator electrode conductive gel on the second non-woven fabric layer; the projection of the second waterproof and moisturizing film of the cardiac electrode on the second non-woven fabric layer covers the projection of the second cardiac electrode conductive gel on the second non-woven fabric layer.

[0014] Optionally, the base has a plurality of first defibrillator female buckles, and the base has the same number of first cardiac electronic electrode female buckles as the first defibrillator female buckles; the RA defibrillator base has a plurality of second defibrillator female buckles, and the RA defibrillator base has the same number of second cardiac electronic electrode female buckles as the second defibrillator female buckles.

[0015] Optionally, the first metal male and female buckle structure and the second metal male and female buckle structure adopt magnetic male and female electrode buckles, spring clip male and female electrode buckles, or plug and socket type male and female electrode buckles.

[0016] Optionally, the wearable external defibrillator system includes: an energy storage battery module, a high-voltage charging drive and transformer module, a capacitor energy storage module, a circuit board module, a status monitoring circuit, and a defibrillation treatment circuit; wherein, the energy storage battery module provides operating current to the status monitoring circuit and the high-voltage charging drive and transformer module; the high-voltage charging drive and transformer module charges the capacitor energy storage module; the capacitor energy storage module stores energy and transmits electrical energy to the defibrillation treatment circuit; the circuit board module electrically connects other modules; the defibrillation treatment circuit discharges defibrillation; and the status monitoring circuit monitors real-time acquired data to determine whether defibrillation is needed and controls the discharge of the defibrillation treatment circuit.

[0017] Optionally, the status monitoring circuit includes: a low-voltage power conversion module, a low-voltage functional circuit and main control module, a speaker-ambient-MIC temperature and humidity sensor module, a body sensor module, a vibration warning module, and a button indicator module; the low-voltage power conversion module is used to convert the output voltage of the energy storage battery module and provide it to all other modules of the status monitoring circuit; the low-voltage functional circuit and main control module is used to determine whether the electrocardiogram signal collected by the body sensor module is a defibrillable rhythm, and feeds the result back to the high-voltage charging drive and transformer module and the defibrillation treatment circuit; the speaker-ambient-MIC temperature and humidity sensor module is used to collect ambient sound and ambient humidity and transmit the information. The signal is transmitted to the low-voltage function circuit and the main control module, and an audible warning is issued based on the signals from the low-voltage function circuit and the main control module; the vibration warning module issues a vibration warning based on the signals from the low-voltage function circuit and the main control module; the button indicator module issues an alarm light based on the signals from the low-voltage function circuit and the main control module, and the false alarm can be canceled by pressing a button; the defibrillation treatment circuit includes a high-voltage discharge biphasic bridge and drive module and a high-voltage discharge variable resistor module; the high-voltage discharge biphasic bridge and drive module is used to perform biphasic wave discharge on the wearer through the detachable LL defibrillation electrode pads and the detachable RA defibrillation electrode pads; the high-voltage discharge variable resistor module is used to adjust the defibrillation current in multiple stages.

[0018] Secondly, the present invention provides a control method for a wearable external defibrillator, comprising the following steps: Condition monitoring is performed through a condition monitoring circuit; When the status monitoring circuit determines that defibrillation is required, it activates the high-voltage charging drive and transformer module to charge the capacitor energy storage module with high voltage. Electrical energy is transmitted to the defibrillation treatment circuit via a capacitor energy storage module.

[0019] Compared with the prior art, the present invention has the following beneficial effects: The integrated main unit and the detachable LL defibrillator electrode pads, as well as the RA defibrillator electrode base and the detachable RA defibrillator electrode pads of this invention, are reliably connected using a common and technologically mature metal male-female buckle structure, making them difficult to detach. Adjacent sub-electrode units are independently arranged, with each conductive gel positioned on a separate sub-electrode unit. Gaps exist between the conductive gels, preventing water absorption and denaturation during daily activities, including showering, or immersion in the wearer's skin, thus ensuring the basic requirements for long-term wear. The metal male-female buckle structure allows for a retractable gap between the integrated main unit and the detachable LL defibrillator electrode pads after wearing, without affecting the breathability and moisture permeability of the electrode pads, ensuring the basic requirements for long-term wear. The electrode pad structure of this invention is simple, without complex manufacturing processes. It uses mature electrode pad materials and manufacturing processes, making it easy to produce without requiring the development of new production equipment or auxiliary tools for attaching the electrode pads to the skin.

[0020] Furthermore, the main body of the detachable LL defibrillator electrode pad and the detachable RA defibrillator electrode pad of the present invention is non-woven fabric with single-sided adhesive, which has strong adhesion to the skin, so that after the integrated host is mounted on the detachable LL defibrillator electrode pad, the detachable LL defibrillator electrode pad is not easy to detach from the skin.

[0021] Furthermore, the outer extension plate of the male buckle and the outer extension plate of the bottom buckle of the present invention are provided with a waterproof and moisturizing membrane, a non-woven fabric layer and an insulating adhesive layer in sequence. The detachable LL defibrillator electrode and the detachable RA defibrillator electrode have excellent breathability and moisture permeability. The waterproof and moisturizing membrane has certain waterproof and moisturizing functions. The conductive gel will not lose water when the electrode is attached to the skin for a long time.

[0022] Furthermore, the nonwoven fabric single-sided adhesive composed of the nonwoven fabric layer and the insulating adhesive layer of the present invention has excellent air and moisture permeability, and the material is thin and lightweight, which reduces the overall weight of the electrode sheet while ensuring performance. Attached Figure Description

[0023] The accompanying drawings described herein are for illustrative purposes only and are not intended to limit the scope of the invention in any way. Furthermore, the shapes and proportions of the components in the drawings are merely schematic to aid in understanding the invention and do not specifically limit the shapes and proportions of the components. In the drawings: Figure 1 This is a top view of the overall structure of an embodiment of the present invention; Figure 2 This is a cross-sectional layered structural diagram of the integrated host and LL defibrillation electrodes according to an embodiment of the present invention; Figure 3 This is a cross-sectional layered structure diagram of the RA defibrillation electrode according to an embodiment of the present invention; Figure 4This is an assembly diagram of the layered structure of the male metal electrode snap-fit ​​according to an embodiment of the present invention; (a) is the first layered structure of the male metal electrode snap-fit; (b) is the second layered structure of the male metal electrode snap-fit. Figure 5 This is a layout diagram of the detachable LL defibrillator electrode pad ECG and the first defibrillator sub-electrode of the present invention. Figure 6 This is a layout diagram of the detachable RA defibrillation electrode pad ECG and the first defibrillation sub-electrode of the present invention. Figure 7 This is a layout diagram of the base ECG and the first defibrillator female electrode buckle according to an embodiment of the present invention; Figure 8 The following are schematic diagrams of the front and bottom surfaces of the RA electrode base according to an embodiment of the present invention; (a) is a schematic diagram of the front shape of the RA defibrillation electrode base and the planar layout of the first defibrillation sub-electrode female buckle and the first cardiac electronic electrode female buckle; (b) is a schematic diagram of the bottom shape of the defibrillation electrode base. Figure 9 The diagram shows the electrical connection relationship of the female sub-electrode inside the defibrillator electrode base according to an embodiment of the present invention; (a) is a diagram of the electrode connection of the first defibrillator female sub-electrode and the cardiac electronic electrode metal female inside the RA defibrillator electrode base; (b) is a diagram of the connection of the defibrillator female sub-electrode and the cardiac electronic electrode metal female inside the base. Figure 10 This is a functional module structure diagram of the wearable fully automated external defibrillator system according to an embodiment of the present invention; Figure 11 This is a functional distribution diagram of the internal modules of the integrated host according to an embodiment of the present invention; The components include: LL and LL defibrillation electrodes; RA and RA defibrillation electrodes; 1. Integrated main unit; 11. Outer shell; 12. Base; 13. First metal female buckle; 131. First defibrillator electrode female buckle; 132. First cardiac electronic electrode female buckle; 2. Detachable LL defibrillation electrode pad; 201. First non-woven fabric layer; 202. First insulating adhesive layer; 23. First metal male buckle; 231. First defibrillator electrode male buckle; 232. First cardiac electronic electrode male buckle; 2301. First male buckle face buckle; 2302. First bottom buckle; 24. First waterproof and moisturizing film; 241. Defibrillator first waterproof and moisturizing film. 242. First waterproof and moisturizing membrane for cardiac defibrillator; 25. First conductive gel; 251. Conductive gel for first defibrillator electrode; 252. Conductive gel for first cardiac defibrillator electrode; 3. RA defibrillator electrode base; 33. Second metal female buckle; 331. Second defibrillator electrode female buckle; 332. Second cardiac defibrillator electrode female buckle; 4. Detachable RA defibrillator electrode sheet; 401. Second non-woven fabric layer; 402. Second insulating adhesive layer; 43. Second metal male buckle; 431. Second defibrillator electrode male buckle; 432. Second cardiac defibrillator electrode male buckle; 4301. Second male buckle face buckle; 4302. Second bottom buckle. ; 44. Second waterproof and moisturizing membrane; 441. Second waterproof and moisturizing membrane for defibrillator; 442. Second waterproof and moisturizing membrane for cardiac electronics; 45. Second conductive gel; 451. Conductive gel for second defibrillator electrode; 452. Conductive gel for second cardiac electronics electrode; 35. RA defibrillator electrode hub; 36. RA defibrillator electrode cable; 101. First module; 102. Second module; 103. Third module; 104. Fourth module; 105. Fifth module; 20. Body sensor through-hole; 10. Optical sensor circuit module; 15. Anti-defibrillation circuit unit; 16. Current column; 17. Cardiac telecommunications Connector No. 151; Left strap loop; 150; Right strap loop; 160; Debounce / disruption confirmation button; 90; Energy storage battery module; 91; Low-voltage power conversion module; 92; Low-voltage functional circuit and main control module; 93; Speaker-ambient-MIC temperature and humidity sensor module; 94; Body contact sensor module; 95; Vibration warning module; 96; Button indicator light module; 97; High-voltage charging drive and transformer module; 98; Capacitor energy storage module; 99; High-voltage discharge two-phase bridge and drive module; 9A; High-voltage discharge variable resistor module; 100; Circuit board module; LF; Status monitoring circuit. Detailed Implementation

[0024] To enable those skilled in the art to better understand the technical solutions of this invention, the technical solutions of the embodiments of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this invention.

[0025] Therefore, the following detailed description of embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention.

[0026] In the description of the embodiments of the present invention, it should be noted that if terms such as "upper", "lower", "horizontal", "inner" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is usually placed during use, they are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention.

[0027] When an element is referred to as being "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only embodiments. The use of the term "horizontal" does not imply that the component is required to be absolutely horizontal, but rather that it may be slightly tilted. "Horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it may be slightly tilted.

[0028] It should be noted that similar reference numerals and letters in the following figures denote similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. In the description of this invention, it should be understood that the terms "comprising" and "including" indicate the presence of the described features, integrals, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components, and / or collections thereof.

[0029] Unless otherwise defined, 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 pertains. The terminology used herein in the specification of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used in the specification and appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context clearly indicates otherwise.

[0030] The present invention will now be described in detail with reference to the accompanying drawings.

[0031] The present invention provides a wearable external defibrillator, comprising: an integrated main unit 1, an LL defibrillator electrode LL, and an RA defibrillator electrode RA.

[0032] The LL defibrillation electrode LL includes a detachable LL defibrillation electrode piece 2 and a base 12 that are interconnected by a first metal male and female snap structure.

[0033] The RA defibrillation electrode RA includes an RA defibrillation electrode base 3 and a detachable RA defibrillation electrode sheet 4, which are interconnected by a second metal male and female buckle structure.

[0034] The base 12 and the RA defibrillation electrode base 3 are both electrically connected to the integrated host 1.

[0035] In the first metal male and female buckle structure, a first conductive gel 25 and a second conductive gel 45 are respectively provided outside the metal male or metal female buckle on the detachable LL defibrillator electrode 2, and in the second metal male and female buckle structure, a first conductive gel 25 and a second conductive gel 45 are respectively provided outside the metal male or metal female buckle on the detachable RA defibrillator electrode 4.

[0036] The first metal male-female snap structure is used as the first sub-electrode unit; the second metal male-female snap structure is used as the second sub-electrode unit.

[0037] The present invention discloses a wearable fully automated external defibrillator system, comprising: an integrated host 1 of the wearable external defibrillator, an energy storage battery module 90, a high-voltage charging drive and transformer module 97, a capacitor energy storage module 98, a circuit board module 100, a status monitoring circuit LF, and a defibrillation treatment circuit; wherein, the energy storage battery module 90 is used to provide operating current to the status monitoring circuit LF and the defibrillation treatment circuit; the high-voltage charging drive and transformer module 97 is used to charge the capacitor energy storage module 98; the capacitor energy storage module 98 is used to store energy and transmit electrical energy to the defibrillation treatment circuit; the circuit board module 100 is used to electrically connect the other modules to each other; the defibrillation treatment circuit is used for defibrillation discharge; and the status monitoring circuit LF is used to monitor real-time acquired data to determine whether defibrillation is needed and to control the discharge of the defibrillation treatment circuit.

[0038] The integrated host 1 and the detachable LL defibrillator electrode pad 2, and the RA defibrillator electrode base 3 and the detachable RA defibrillator electrode pad 4 of this invention are reliably connected using a common and technologically mature metal male-female buckle structure, making them difficult to detach. The first conductive gel 25 of each electrode is disposed on the mutually separated first sub-electrode units, with gaps between the first conductive gels 25. Therefore, it will not absorb water and deform due to daily activities such as showering, or soak the wearer's skin, ensuring the basic requirements for long-term wear. The metal male-female buckle structure allows for a stretchable gap between the integrated host 1 and the detachable LL defibrillator electrode pad 2 after wearing, without affecting the breathability and moisture permeability of the electrode pad, ensuring the basic requirements for long-term wear. The electrode pad structure of this invention is simple, without complex manufacturing processes. It uses mature electrode pad materials and manufacturing processes, making it easy to produce. It eliminates the need for developing new production equipment or auxiliary tools for attaching the electrode pads to the skin.

[0039] Example 1 Combination Figure 1 and Figure 2 The present invention provides a wearable patch-type fully automated external defibrillator, comprising: an integrated main unit 1, an LL defibrillation electrode LL, and an RA defibrillation electrode RA.

[0040] The LL defibrillation electrode LL includes a detachable LL defibrillation electrode pad 2 and a base 12.

[0041] The RA defibrillation electrode RA includes an RA defibrillation electrode base 3 and a detachable RA defibrillation electrode pad 4.

[0042] The integrated host 1 includes a defibrillator main device module.

[0043] The integrated host 1 is connected to the RA defibrillator electrode base 3 via the RA defibrillator electrode cable 36.

[0044] The integrated host 1, RA defibrillator electrode cable 36 and RA defibrillator electrode base 3 are reusable, while the detachable RA defibrillator electrode pad 4 and detachable LL defibrillator electrode pad 2 are for single use.

[0045] The base 12 of the integrated host 1 is provided with a left strap ring 151 and a right strap ring 150 at both ends. These are used to reinforce the device host in the form of a patch by installing an elastic bandage around the waist when the wearer is exercising or engaging in prolonged outdoor activities. This prevents the integrated host 1 from falling off the detachable LL defibrillator electrode 2 or the integrated host 1 and the detachable LL defibrillator electrode 2 from leaving the skin during exercise.

[0046] The integrated host 1 includes a base 12 and five structurally separate modules. The modules include a first module 101, a second module 102, a third module 103, a fourth module 104, and a fifth module 105. Each module is covered by a shell 11, which is made of a flexible material.

[0047] Optionally, the outer casing 11 of the first module 101 is provided with two cancel defibrillation confirmation buttons 160, which are connected in series.

[0048] Optionally, the outer shell 11 is made of soft silicone or soft plastic, and the base 12 is made of silicone. The outer shell 11 is fixed to the base 12 by adhesive or welding.

[0049] The bottom of the base 12 is embedded with several first metal female buckles 13, and the bottom of the RA defibrillation electrode base 3 is embedded with several first metal female buckles 13.

[0050] The detachable RA defibrillator electrode 4 has several second metal male buckles 43 that match the second metal female buckle 33; the detachable LL defibrillator electrode 2 has several first metal male buckles 23 that match the first metal female buckle 13.

[0051] Each interconnected first metal female buckle 13 and first metal male buckle 23 constitutes a first sub-electrode unit.

[0052] Each interconnected second metal female buckle 33 and second metal male buckle 43 constitutes a second sub-electrode unit.

[0053] The first metal male buckle 23 is provided with a first conductive gel 25 at the end away from the first metal female buckle 13.

[0054] The second metal male buckle 43 is provided with a second conductive gel 45 at the end away from the second metal female buckle 33.

[0055] Optionally, the first metal female buckle 13, the first metal male buckle 23, the second metal female buckle 33, and the second metal male buckle 43 are all snap fasteners or magnetic buckles.

[0056] The first metal female buckle 13 includes a first defibrillator electrode female buckle 131 and a first cardiac electronic electrode female buckle 132.

[0057] The first metal male buckle 23 includes a first defibrillator male buckle 231 corresponding to the position of the first defibrillator female buckle 131 and a first cardiac electronic electrode male buckle 232 corresponding to the position of the first cardiac electronic electrode female buckle 132.

[0058] The first cardiac electronic electrode female buckle 132 and the first cardiac electronic electrode male buckle 232 constitute the cardiac electronic electrode. The first defibrillator electrode female buckle 131 and the first defibrillator electrode male buckle 231 constitute the defibrillator electrode.

[0059] The second metal female buckle 33 includes the second defibrillator electrode female buckle 331 and the second cardiac electronic electrode female buckle 332.

[0060] The second metal male buckle 43 includes a second defibrillator male buckle 431 corresponding to the position of the second defibrillator female buckle 331 and a second cardiac electronic electrode male buckle 432 corresponding to the position of the second cardiac electronic electrode female buckle 332.

[0061] The second cardiac electronic electrode female buckle 332 and the second cardiac electronic electrode male buckle 432 constitute the cardiac electronic electrode. The second defibrillator electrode female buckle 331 and the second defibrillator electrode male buckle 431 constitute the defibrillator electrode.

[0062] like Figure 2 As shown, the base 12 is embedded with several first defibrillator female buckles 131 and first cardiac electronic electrode female buckles 132; the top of the detachable LL defibrillator electrode 2 is equipped with several first defibrillator male buckles 231 and first cardiac electronic electrode male buckles 232.

[0063] like Figure 3 As shown, the RA defibrillator electrode base 3 is embedded with several second defibrillator female buckles 331 and second cardiac electronic electrode female buckles 332; the top of the detachable RA defibrillator electrode 4 is equipped with several second defibrillator male buckles 431 and second cardiac electronic electrode male buckles 432.

[0064] Each first defibrillator male buckle 231 is provided with a first defibrillator conductive gel 251 at the end away from the first defibrillator female buckle 131; each first cardiac electronic electrode male buckle 232 is provided with a first cardiac electronic electrode conductive gel 252 at the end away from the first cardiac electronic electrode female buckle 132.

[0065] Each second defibrillator male buckle 431 is provided with a second defibrillator conductive gel 451 at the end away from the second defibrillator female buckle 331; each second cardiac electronic electrode male buckle 432 is provided with a second cardiac electronic electrode conductive gel 452 at the end away from the second cardiac electronic electrode female buckle 332.

[0066] like Figure 4As shown in (a), the first metal male buckle 23 consists of a first bottom buckle 2302 and a first male buckle face buckle 2301 sleeved on the first bottom buckle 2302. The bottom of the first male buckle face buckle 2301 and the bottom of the first bottom buckle 2302 both have an extension plate. Between the extension plate of the first male buckle face buckle 2301 and the extension plate of the first bottom buckle 2302, a first waterproof and moisturizing film 24, a first non-woven fabric layer 201 and a first insulating adhesive layer 202 are sequentially provided.

[0067] like Figure 4 As shown in (b), the second metal male buckle 43 consists of a second bottom buckle 4302 and a second male buckle face buckle 4301 sleeved on the second bottom buckle 4302. The bottom of the second male buckle face buckle 4301 and the bottom of the second bottom buckle 4302 both have an extension plate. Between the extension plate of the second male buckle face buckle 4301 and the extension plate of the second bottom buckle 4302, a second waterproof and moisturizing film 44, a second non-woven fabric layer 401 and a second insulating adhesive layer 402 are sequentially provided.

[0068] Specifically, the size of the first nonwoven layer 201 of the removable LL defibrillator electrode 2 matches the size of the base 12; the size of the second nonwoven layer 401 of the removable RA defibrillator electrode 4 matches the size of the RA defibrillator electrode base 3.

[0069] The first defibrillator female connector 131, the first defibrillator male connector 231, the second defibrillator female connector 331, and the second defibrillator male connector 431 are used for defibrillation discharge.

[0070] The first electronic electrode female buckle 132, the first electronic electrode male buckle 232, the second electronic electrode female buckle 332, and the second electronic electrode male buckle 432 are used to collect the wearer's electrocardiogram (ECG) signals.

[0071] Optionally, the first nonwoven layer 201 and the second nonwoven layer 401 are made of nonwoven fabric or foam.

[0072] The detachable LL defibrillator electrode 2 is engaged with the first defibrillator female buckle 131 and the first cardiac electronic electrode female buckle 132 below the base 12 through the first defibrillator male buckle 231 and the first cardiac electronic electrode male buckle 232, so that the detachable LL defibrillator electrode 2 can be fixed to the bottom of the integrated host 1 on one side, and then adhered to the human skin through the first insulating adhesive layer 202, the first defibrillator conductive gel 251 and the first cardiac electronic electrode conductive gel 252.

[0073] The detachable RA defibrillator electrode 4 is engaged with the second defibrillator female buckle 331 and the second cardiac electronic electrode female buckle 332 on the RA defibrillator electrode base 3 through the second defibrillator male buckle 431 and the second cardiac electronic electrode male buckle 432, so that the detachable RA defibrillator electrode 4 can be fixed to the RA defibrillator electrode base 3 on one side, and then adhered to the human skin through the second insulating adhesive layer 402, the second defibrillator conductive gel 451 and the second cardiac electronic electrode conductive gel 452.

[0074] The shape and size of the first waterproof and moisturizing film 24 are matched with the size of the first conductive gel 25. This protects the first conductive gel 25 from moisture entering its outer layer (outer part of the first nonwoven fabric layer 201) and also prevents excessive evaporation of moisture from the inside of the first conductive gel 25 due to skin temperature. The diameter of the first waterproof and moisturizing film 24 is greater than or equal to the diameter of the first conductive gel 25, and the projection of the first waterproof and moisturizing film 24 onto the first nonwoven fabric layer 201 overlaps the projection of the first conductive gel 25 onto the first nonwoven fabric layer 201.

[0075] The first waterproof and moisturizing film 241 of the defibrillator is sandwiched between the first male fastener face 2301 of the first defibrillator electrode male fastener 231 and the first non-woven fabric layer 201; the first waterproof and moisturizing film 242 of the cardiac electronic device is sandwiched between the first male fastener face 2301 of the first cardiac electronic device male fastener 232 and the first non-woven fabric layer 201. The first waterproof and moisturizing film 242 of the cardiac electronic device is sandwiched between the first cardiac electronic device male fastener 232 and the first cardiac electronic device female fastener 132. The projection of the first waterproof and moisturizing film 241 of the defibrillator on the first non-woven fabric layer 201 overlaps the projection of the first defibrillator electrode conductive gel 251 on the first non-woven fabric layer 201; the projection of the first waterproof and moisturizing film 242 of the cardiac electronic device on the first non-woven fabric layer 201 overlaps the projection of the first cardiac electronic device conductive gel 252 on the first non-woven fabric layer 201.

[0076] The shape and size of the second waterproof and moisturizing film 44 match the size of the second conductive gel 45. It is used to prevent moisture from the outside of the second nonwoven fabric layer 401 from entering the second conductive gel 45, and also to prevent excessive evaporation of moisture inside the second conductive gel 45 due to skin temperature. The diameter of the second waterproof and moisturizing film 44 is greater than or equal to the diameter of the second conductive gel 45, and the projection of the second waterproof and moisturizing film 44 onto the second nonwoven fabric layer 401 overlaps the projection of the second conductive gel 45 onto the second nonwoven fabric layer 401.

[0077] The second waterproof and moisturizing film 441 of the defibrillator is sandwiched between the second male fastener face 4301 of the second defibrillator electrode male fastener 431 and the second non-woven fabric layer 401; the second waterproof and moisturizing film 442 of the cardiac electronic device is sandwiched between the second male fastener face 4301 of the second cardiac electronic device male fastener 432 and the second non-woven fabric layer 401. The second waterproof and moisturizing film 442 of the cardiac electronic device is sandwiched between the second cardiac electronic device male fastener 432 and the second cardiac electronic device female fastener 332. The projection of the second waterproof and moisturizing film 441 of the defibrillator on the second non-woven fabric layer 401 overlaps the projection of the second defibrillator electrode conductive gel 451 on the second non-woven fabric layer 401; the projection of the second waterproof and moisturizing film 442 of the cardiac electronic device on the second non-woven fabric layer 401 overlaps the projection of the second cardiac electronic device conductive gel 452 on the second non-woven fabric layer 401.

[0078] Optionally, all the first defibrillator male contacts 231 and second defibrillator male contacts 431 on the detachable LL defibrillator electrode pad 2 and the detachable RA defibrillator electrode pad 4 are manufactured and assembled using the same type of metal electrode material, and have the same shape and size. Similarly, all the first cardiac electrode male contacts 232 and second cardiac electrode male contacts 432 are manufactured and assembled using the same type of metal electrode material, and have the same shape and size. All the first defibrillator female contacts 131 and second defibrillator female contacts 331 are manufactured and assembled using the same type of metal electrode material, and have the same shape and size. All the first cardiac electrode female contacts 132 and second cardiac electrode female contacts 332 are manufactured and assembled using the same type of metal electrode material, and have the same shape and size.

[0079] Preferably, the diameter of the first defibrillator electrode conductive gel 251 is larger than the diameter of the first cardiac electrode conductive gel 252. The diameter of the second defibrillator electrode conductive gel 451 is larger than the diameter of the second cardiac electrode conductive gel 452.

[0080] Optionally, for ease of production, the diameters of the first defibrillator electrode conductive gel 251, the first cardiac electrode conductive gel 252, the second defibrillator electrode conductive gel 451, and the second cardiac electrode conductive gel 452 are all the same.

[0081] Figure 5 A schematic plan view showing the planar structure of the first nonwoven fabric layer 201 of the detachable LL defibrillator electrode 2, and the positional layout of the first cardiac electrode male buckle 232 and the first defibrillator sub-electrode male buckle 231.

[0082] The first nonwoven fabric layer 201 is made of single-sided adhesive nonwoven fabric. The first cardiac electrode male buckle 232 and the first defibrillator electrode male buckle 231 are both located inside the first nonwoven fabric layer 201.

[0083] Specifically, in this embodiment, sixteen first defibrillator male buckles 231 in four rows and four columns are provided in the middle of the first non-woven fabric layer 201 of the detachable LL defibrillator electrode pad 2, and five first cardiac electronic electrode male buckles 232 are provided at the four corners and the blank area on the right side of the middle of the first non-woven fabric layer 201.

[0084] Optionally, such as Figure 5 As shown, a skin-fitting sensor through-hole 20 is formed on the first non-woven fabric layer 201. An optical sensor circuit module 10 is connected to the base 12. The optical sensor circuit module 10 is a cylinder with a diameter smaller than that of the skin-fitting sensor through-hole 20. After passing through the skin-fitting sensor through-hole 20, the optical sensor circuit module 10 is in close contact with the skin and extracts the pulse wave and heart sound signals of the human body through an optical pulse wave sensor and a heart sound sensor.

[0085] Figure 6 This is a schematic diagram of the planar structure of the second nonwoven fabric layer 401 of the detachable RA defibrillator electrode pad 4, as well as the planar layout of the second cardiac electrode male buckle 432 and the second defibrillator male buckle 431.

[0086] The second nonwoven fabric layer 401 of the detachable RA defibrillator electrode pad 4 has three independent second cardiac electrode male buckles 432 at three edges; and nine independent second defibrillator male buckles 431 in three rows and three columns are provided in the center of the electrode pad.

[0087] Figure 7 This is a schematic diagram showing the shape of the base 12 integrated into the lower part of the base 12 of the integrated host 1, as well as the planar layout of the first defibrillator electrode female buckle 131 and the first cardiac electronic electrode female buckle 132.

[0088] Five independent male and female first cardiac electrode clips 132 are provided at the four corners and the right side of the base 12, corresponding to the positions of the male first cardiac electrode clips 232 of the detachable LL defibrillator electrode pad 2. Sixteen female first defibrillator clips 131, in four rows and four columns, are provided on the left side of the base 12, corresponding to the positions of the male first defibrillator clips 231 of the detachable LL defibrillator electrode pad 2.

[0089] Optionally, an optical sensor circuit module 10 corresponding to the position of the close-fitting sensor through hole 20 is provided on the upper part of the base 12. The optical sensor circuit module 10 is equipped with an optical pulse sensor and a heart sound sensor and circuitry inside, which are used to collect pulse wave and heart sound signals to confirm that the wearer is in cardiac arrest in special and extreme situations.

[0090] Figure 8 (a) is a schematic diagram of the front view of the RA defibrillation electrode base 3 and the planar layout of the second defibrillation sub-electrode female buckle 331 and the second cardiac electronic electrode female buckle 332. Figure 8(b) is a schematic diagram of the bottom surface of the RA defibrillation electrode base 3.

[0091] The RA defibrillator electrode base 3 has three independent second cardiac electronic electrode female buckles 332 at the bottom edge; and three rows and three columns of nine second defibrillator female electrode female buckles 331 in the center of the RA defibrillator electrode base 3.

[0092] The position of the second defibrillator female buckle 331 on the RA defibrillator electrode base 3 corresponds to the position of the second defibrillator male buckle 431 on the detachable RA defibrillator electrode pad 4; the position of the second cardiac electronic electrode female buckle 332 corresponds to the position of the second cardiac electronic electrode male buckle 432 on the detachable RA defibrillator electrode pad 4.

[0093] The front surface of the RA defibrillator electrode base 3 is flat and covered with a second non-woven fabric layer 401. The defibrillation current and electrocardiogram signal in the RA defibrillator electrode RA are collected by the RA defibrillator electrode hub 35 on the front of the RA defibrillator electrode base 3 and connected to the integrated host 1 through the RA defibrillator electrode cable 36.

[0094] Figure 9 (a) shows the electrode connection diagram of the second defibrillator female buckle 331 and the second cardiac electronic electrode female buckle 332 inside the RA defibrillator electrode base 3.

[0095] The nine second defibrillator female buckles 331 of the RA defibrillator electrode base 3 are interconnected and connected to the RA defibrillator electrode hub 35, forming RA defibrillation current conductors through internal short-circuit connections.

[0096] The second cardiac electronic electrode female buckle 332 of the RA defibrillator electrode base 3 is connected to the RA defibrillator electrode hub 35 to form ECG lead signal leads at three locations. The RA defibrillator current lead and the three ECG lead signal leads converge at the RA defibrillator electrode hub 35 and are connected to the integrated host 1 via the RA defibrillator electrode cable 36.

[0097] Figure 9 (b) shows the wiring diagram of the first defibrillator female connector 131 and the first cardiac electronic electrode female connector 132 inside the base 12. The base 12 is provided with a current column 16, an anti-defibrillation circuit unit 15 and an electrocardiogram signal connector 17. The integrated host 1 has a circuit board module 100 inside.

[0098] Among them, the first defibrillator female buckles 131 of the base 12 are interconnected, forming an LL defibrillation current conductor through an internal short circuit connection, and converge to the current column 16, which is connected to the circuit board module 100 inside the integrated host 1.

[0099] Optionally, the signal line of the current column 16 passes through the internal defibrillation circuit unit 15 to form a lead ECG signal, which is then fed into the ECG signal connector 17.

[0100] Five first cardiac electronic electrode female buckles 132 are individually connected to the cardiac signal connector 17 via five cardiac signal lines. The cardiac signal lines of the five first cardiac electronic electrode female buckles 132 and the cardiac signal of the anti-defibrillation circuit unit 15 form six cardiac lead signals at different locations.

[0101] When wearing and using the device, the bottom surface of the detachable LL defibrillator electrode pad 2 is attached to the wearer's skin. The integrated host 1 is connected to the detachable LL defibrillator electrode pad 2 by all the first metal female buckles 13 on the base 12 and all the first metal male buckles 23 on the detachable LL defibrillator electrode pad 2, thus fixing the integrated host 1 to the detachable LL defibrillator electrode pad 2.

[0102] The conductive gel 252 of each first cardiac electronic electrode of the detachable LL defibrillator electrode pad 2 is in close contact with the skin, transmitting human electrocardiogram signals from different parts of the body to the male first cardiac electronic electrode buckle 232, and then sending the signals into the integrated host 1 through the female first cardiac electronic electrode buckle 132 on the base 12.

[0103] During defibrillation treatment, the defibrillation current travels through the wires inside the base 12 to the first defibrillation electrode female buckle 131 of the LL defibrillation electrode LL, and then flows into the human body through the first defibrillation electrode male buckle 231 and the first defibrillation electrode conductive gel 251.

[0104] After the defibrillation current passes through the heart, it exerts its defibrillation therapeutic effect. Then, it passes through the RA defibrillation electrode's first defibrillator conductive gel 251, first defibrillator male buckle 231, and first defibrillator female buckle 131, and then... Figure 9 The internal wiring of the base shown flows back to the integrated host unit 1 via the RA defibrillation electrode cable 36.

[0105] During the use of the device of the present invention, the five ECG signals collected by the base 12 of the integrated host 1 and the five first ECG electronic electrode female buckles 132 on the detachable LL defibrillator electrode pad 2, the LL ECG signals extracted after processing by the anti-defibrillation circuit unit 15 by the 16 first defibrillator sub-electrode female buckles 131, the three ECG signals collected by the three first ECG electronic electrode female buckles 132 on the RA defibrillator electrode base 3 and the detachable RA defibrillator electrode pad 4, and the RA ECG signals extracted after short-circuiting the nine first defibrillator sub-electrode female buckles 131 and short-circuiting by the anti-defibrillation circuit unit 15, together form an ECG detection system with 10 leads. The signals are input into the lead ECG front-end signal processing chip inside the integrated host 1 and output as ECG signals.

[0106] Any independent first sub-electrode unit on the base 12 can form an electrocardiogram signal with any second sub-electrode unit on the RA defibrillation electrode base 3.

[0107] The integrated host 1 can output status signals and ECG waveform signals for each ECG signal. The status signal indicates whether the lead is detached or connected normally. The lead detachment status indicates that there is an abnormal electrical conduction between the electrode adhesive and the skin at the corresponding location, which manifests as the electrode adhesive detaching or bulging, triggering a system prompt or alarm.

[0108] The detachment of leads formed between cardiac electrodes and defibrillator electrodes can trigger an electrode adhesion alarm. This function enables real-time monitoring of electrode adhesion quality, alerting the wearer to correct or replace the electrode when poor adhesion occurs, thus preventing delays in treatment due to poor WCD electrode adhesion.

[0109] The WCD electrode sheet of the present invention integrates several first conductive gels 25 and first metal male buckles 23 on a base material, namely the first non-woven fabric layer 201, which has an area that is tens of times larger than that of ordinary ECG electrodes. The first conductive gels 25 are not connected to each other and are isolated by the first insulating adhesive layer 202 between the first conductive gels 25.

[0110] The first insulating adhesive layer 202 plays a major adhesive role and has excellent breathability, ensuring normal skin respiration and metabolism even after 7-15 days of long-term wear. A waterproof protective film 24 prevents the first conductive gel 25 from drying out and losing its electrical conductivity.

[0111] This invention ensures both the area of ​​the WCD electrode pad and strong adhesion, while also possessing excellent breathability and moisture permeability. Therefore, it can be worn on the skin for extended periods without hindering skin respiration and perspiration. The relatively small area of ​​the first conductive gel 25 allows absorbed sweat and shower water to be expelled through the surrounding breathable and moisture-permeable first non-woven fabric layer 201 when the skin sweats or the WCD device is in a shower, thus maintaining the moisturizing function of the first conductive gel 25 on the WCD electrode pad. This ensures that the WCD electrode pad can be worn for extended periods without causing abnormal or adverse skin reactions.

[0112] The WCD electrode pad of the present invention has strong adhesion and can support the weight of the integrated host 1 of 500-900 grams for a long time. Its good overall breathability, moisture permeability and moisturizing ability can also ensure that the skin can perform normal metabolic function at the contact point between the electrode pad and the skin during long-term wear, thereby achieving the long-term wear capability of the patch-type WCD device for 7 to 201 days.

[0113] The integrated host 1 of this invention monitors the human body's physiology through detachable LL defibrillation electrode pads 2 and detachable RA defibrillation electrode pads 4, and performs defibrillation treatment when cardiac arrest is detected in the wearer. After the wearable external defibrillator is worn and attached to the surface of the human skin, the status monitoring circuit LF of the entire system enters the working state, while the defibrillation treatment circuit is in the off state.

[0114] Example 2 The present invention discloses a wearable fully automatic external defibrillator system, comprising: an energy storage battery module 90, a high-voltage charging drive and transformer module 97, a capacitor energy storage module 98, a circuit board module 100, a detachable LL defibrillator electrode 2, a detachable RA defibrillator electrode 4, a status monitoring circuit LF, and a defibrillation treatment circuit.

[0115] The status monitoring circuit LF includes: a low-voltage power conversion module 91, a low-voltage function circuit and main control module 92, a speaker-ambient-MIC temperature and humidity sensor module 93, a body contact sensor module 94, a vibration warning module 95, and a button indicator module 96.

[0116] The defibrillation treatment circuit includes a high-voltage discharge biphase bridge and drive module 99 and a high-voltage discharge variable resistor module 9A.

[0117] The energy storage battery module 90 provides operating current to the status monitoring circuit LF and the defibrillation treatment circuit. The defibrillation treatment circuit only activates after the status monitoring circuit LF detects cardiac arrest in the wearer, while the status monitoring circuit LF operates continuously during patient wear. Specifically, the energy storage battery module 90 preferably uses disposable lithium batteries in a 2x2 parallel-series configuration to provide a 6V voltage output; or it can use a battery pack composed of rechargeable polymer 3.7V high-energy lithium batteries connected in series internally to provide a 7.4V voltage output.

[0118] The low-voltage power conversion module 91 converts the 6V or 7.4V voltage output of the energy storage battery module 90 into a 3V operating voltage, which is then supplied to other modules of the status monitoring circuit LF.

[0119] The low-voltage functional circuit and main control module 92 are composed of an embedded microcontroller system. The low-voltage functional circuit includes an ECG signal front-end processing chip, which is connected to a ten-lead ECG signal processing circuit. Specifically, the ECG signal front-end processing chip is an ADS1298R or ADAS1020 / 1000 chip, or an ADS1292R, along with an external matrix switch chip. The ultra-low-power embedded microcontroller system has a crystal oscillator, a real-time calendar system (RTC), and a large-capacity NandFlash memory component. Additionally, the system has an external RTC real-time clock chip powered by a coin cell battery and a storage battery module 90 to provide a stable clock.

[0120] When the device is worn, the various modules of the status monitoring circuit LF perform monitoring functions: In monitoring mode, the embedded microcontroller system uses the ECG signals collected by the detachable LL defibrillator electrode pads 2 and detachable RA defibrillator electrode pads 4 for ECG signal identification. By determining whether the multi-channel ECG signals are in a lead detachment state, it can determine whether there has been an electrical connection failure in the sensing area of ​​the electrode pads, such as the electrode adhesive detaching from the skin or from the metal sensing point. If an electrical connection failure occurs, the wearer is reminded to press and reinforce the detached electrode adhesive area to restore a good electrical connection between the electrode adhesive and the skin and the bottom of the main unit. In addition, during monitoring, the embedded microcontroller system monitors the wearer's usage environment through the ambient sound mic sensor and temperature and humidity sensor in the speaker-environment-MIC temperature and humidity sensor module 93. If the environment exceeds the reasonable application environment, the vibration warning module 95 will alert the wearer. The low-voltage function circuit and the main control module 92 use an ECG signal recognition algorithm to determine whether the ECG signal is a defibrillable rhythm (ventricular fibrillation, pulseless ventricular tachycardia), thereby diagnosing whether cardiac arrest has occurred.

[0121] When a patient is in cardiac arrest, because blood no longer flows into the extracardiac arteries from the left and right ventricles of the heart, pulmonary and systemic circulation cease. No changes in optical pulse waves can be detected on the body surface, nor can the first and second heart sounds, formed by the atrial and ventricular arteries, be detected. Therefore, the undetectable optical pulse waves and heart sound characteristics are also auxiliary features of cardiac arrest.

[0122] Because the brain becomes oxygen-deprived and the body enters a state of unconsciousness after a prolonged period of cardiac arrest, the respiratory center loses control, and therefore the patient stops breathing, making transthoracic impedance respiratory waves undetectable. The inability to detect respiratory waves in transthoracic impedance signals is thus a contributing characteristic of cardiac arrest.

[0123] By comprehensively identifying cardiac arrest using electrocardiogram signals, optical pulse wave signals, heart sound signals, and transthoracic impedance respiratory wave signals, false identification can be greatly reduced, thereby improving the clinical experience.

[0124] If the selected default ECG signal has significant noise or shows signs of electrode detachment, the system will automatically select a less disturbed ECG signal to identify the presence of regular R waves. If all ECG signals are unusable for analysis and identification, the system will wait for the ECG signal to return to normal. If the ECG signal cannot be restored within the set time, and other auxiliary transthoracic impedance respiratory waves, optical pulse waves, and heart sound signals fail to detect normal blood circulation rhythm characteristics, the system will alert the wearer, stop the monitoring process, issue a device alarm, and remotely notify the responsible personnel that the device has malfunctioned.

[0125] The speaker-ambient-MIC temperature and humidity sensor module 93 includes a speaker, an ambient sound mic sensor, and a temperature and humidity sensor. The vibration warning module 95 includes a vibration motor and a buzzer. The button indicator module 96 includes LED indicators.

[0126] Upon confirmation of cardiac arrest, the embedded controller uses the vibration motor and buzzer in the speaker-ambient-MIC temperature and humidity sensor module 93 and the LED indicator in the button indicator module 96 to issue multiple warnings of varying degrees to alert the wearer to the occurrence of cardiac arrest. First, the vibration warning module 95 alerts the wearer; simultaneously, the high-voltage charging drive and transformer module 97 are activated to begin high-voltage charging of the capacitor energy storage module 98.

[0127] The capacitor energy storage module 98 is composed of five 600uF@400V high-voltage energy storage capacitors connected in series. The equivalent capacitance parameter after series connection is 120uF@2000V. This capacitor can meet the defibrillation treatment energy of preset energy of 50, 70, 85, 100, 125 or 150J. After the vibration warning module 95 issues a warning for 30 seconds, it activates the speaker-ambient-MIC temperature and humidity sensor module 93 and the indicator lights in the button indicator module 96 to provide voice and light warnings. Once the capacitor energy storage module 98 reaches the set voltage and the voice and LED flashing red warnings exceed 30 seconds, if the cancel button in the button indicator module 96 is not detected being pressed, the high-voltage discharge biphase bridge and drive module 99 perform biphase wave discharge on the wearer through the detachable LL defibrillator electrode 2 and the detachable RA defibrillator electrode 4.

[0128] Optionally, the button indicator module 96 has two buttons and an embedded controller electrically connected to the buttons.

[0129] If the wearer is conscious and can determine that the alarm is a false alarm due to recognition error, and presses two buttons in the button indicator module 96 simultaneously within the time window required for voice prompts, the embedded controller will detect the instruction and cancel the current defibrillation treatment.

[0130] The high-voltage discharge variable resistor module 9A is used to adjust the defibrillation current in multiple segments within 6 milliseconds of the first phase of the defibrillation current. It is divided into 1 to 5 segments of isochronous impedance switching of load impedance according to the wearer's impedance. The load variation range is 0 to 50 ohms, with each segment increasing by 10 ohms.

[0131] Figure 11 The diagram shown is a schematic diagram of the functional distribution of the internal modules of the integrated host according to an embodiment of the present invention.

[0132] The first module 101, the second module 102, the third module 103, the fourth module 104, and the fifth module 105 encapsulate a defibrillation treatment circuit, a status monitoring circuit LF, an energy storage battery module 90, a high-voltage charging drive and transformer module 97, and a capacitor energy storage module 98. The capacitor energy storage module 98 includes multiple high-voltage energy storage capacitors.

[0133] Specifically, the first module 101 and the fifth module 105 are located at both ends of the base 12, and the second module 102, the third module 103 and the fourth module 104 are located between the first module 101 and the fifth module 105.

[0134] Specifically, the first module 101 includes a state monitoring circuit LF and an energy storage battery module 90.

[0135] Both the second module 102 and the third module 103 have two high-voltage energy storage capacitors.

[0136] The fourth module 104 contains a defibrillation treatment circuit and a high-voltage energy storage capacitor.

[0137] The high-voltage charging drive and transformer module 97 is located in the fifth module 105.

[0138] Optionally, the number of cardiac electronic electrodes of the LL defibrillator LL is several; the number of defibrillator sub-electrodes of the LL defibrillator LL is greater than or equal to 4; the number of cardiac electronic electrodes of the RA defibrillator RA is arbitrary or no cardiac electronic electrodes are provided on the RA defibrillator RA; the number of defibrillator sub-electrodes of the RA defibrillator RA is greater than or equal to 4.

[0139] Optionally, the defibrillation first conductive gel 25 is circular or rectangular in shape.

[0140] Unless otherwise specified, the equipment components involved in the above embodiments are all conventional equipment components, and the structural settings, working methods or control methods involved are all conventional settings, working methods or control methods in the art unless otherwise specified.

[0141] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Any other modifications or equivalent substitutions made by those skilled in the art to the technical solutions of the present invention, as long as they do not depart from the spirit and scope of the technical solutions of the present invention, should be covered within the scope of the claims of the present invention.

Claims

1. A wearable external defibrillator, characterized in that, include: An integrated host (1), an LL defibrillator (LL), and an RA defibrillator (RA); the LL defibrillator (LL) includes a detachable LL defibrillator pad (2) and a base (12) connected to each other by a first metal male and female buckle structure; the RA defibrillator (RA) includes an RA defibrillator base (3) and a detachable RA defibrillator pad (4) connected to each other by a second metal male and female buckle structure; the base (12) and the RA defibrillator base (3) are electrically connected to the integrated host (1); in the first metal male and female buckle structure, a first conductive gel (25) and a second conductive gel (45) are respectively provided on the outside of the metal male or metal female buckle on the detachable LL defibrillator pad (2) and on the outside of the metal male or metal female buckle on the detachable RA defibrillator pad (4) in the second metal male and female buckle structure; the integrated host (1) encapsulates a wearable external defibrillation system for controlling the operation of the LL defibrillator (LL) and the RA defibrillator (RA).

2. The wearable external defibrillator according to claim 1, characterized in that, The base (12) has a first metal female buckle (13) at its bottom; the detachable LL defibrillator electrode (2) has several first metal male buckles (23) that match the first metal female buckle (13); the RA defibrillator electrode base (3) has a second metal female buckle (33); the detachable RA defibrillator electrode (4) has several second metal male buckles (43) that match the second metal female buckle (33); the first metal female buckle (13) includes a first defibrillator female buckle (131) and a first cardiac electronic electrode female buckle (132); the second metal female buckle (33) includes a second defibrillator female buckle (331) and a second cardiac electronic electrode female buckle (332); the first metal male buckle (23) includes a first defibrillator male buckle (231) corresponding to the position of the first defibrillator female buckle (131). The first defibrillator male buckle (232) is located at the position of the first defibrillator female buckle (132); both the first defibrillator male buckle (231) and the first defibrillator male buckle (232) have a first bottom buckle (2302) and a first male buckle face buckle (2301) fitted on the first bottom buckle (2302); the second metal male buckle (43) includes a second defibrillator male buckle (431) located at the position of the second defibrillator female buckle (331) and a second defibrillator male buckle (432) located at the position of the second defibrillator female buckle (332); both the second defibrillator male buckle (431) and the second defibrillator male buckle (432) have a second bottom buckle (4302) and a second male buckle face buckle (4301) fitted on the second bottom buckle (4302).

3. A wearable external defibrillator according to claim 2, characterized in that, Between the first male buckle face (2301) and the first bottom buckle (2302), a first waterproof and moisturizing film (24), a first non-woven fabric layer (201), and a first insulating adhesive layer (202) are sequentially provided along the first male buckle face (2301) towards the first bottom buckle (2302); between the second male buckle face (4301) and the second bottom buckle (4302), a second waterproof and moisturizing film (44), a second non-woven fabric layer (401), and a second insulating adhesive layer (402) are sequentially provided along the second male buckle face (4301) towards the second bottom buckle (4302); The diameter of the first waterproof and moisturizing film (24) is greater than or equal to the diameter of the first conductive gel (25), and the diameter of the second waterproof and moisturizing film (44) is greater than or equal to the diameter of the second conductive gel (45); the projection of the first waterproof and moisturizing film (24) on the first nonwoven fabric layer (201) covers the projection of the first conductive gel (25) on the first nonwoven fabric layer (201); the projection of the second waterproof and moisturizing film (44) on the second nonwoven fabric layer (401) covers the projection of the second conductive gel (45) on the second nonwoven fabric layer (401).

4. A wearable external defibrillator according to claim 3, characterized in that, The first waterproof and moisturizing film (24) includes a defibrillator first waterproof and moisturizing film (241) and an electronic cardioverter first waterproof and moisturizing film (242). The defibrillator first waterproof and moisturizing film (241) is sandwiched between the first male fastener (2301) and the first nonwoven fabric layer (201); the electronic cardioverter first waterproof and moisturizing film (242) is sandwiched between the first male fastener (2301) and the first nonwoven fabric layer (201); the second conductive gel (45) includes a second defibrillator electrode conductive gel (451) and a second electronic cardioverter electrode conductive gel (452); the second defibrillator electrode male fastener (431) is located away from the second defibrillator electrode female fastener (331). Each end is provided with a second defibrillator electrode conductive gel (451); the end of the second cardiac electrode male buckle (432) away from the second cardiac electrode female buckle (332) is provided with a second cardiac electrode conductive gel (452); the second waterproof and moisturizing film (44) includes a defibrillator second waterproof and moisturizing film (441) and a cardiac electrode second waterproof and moisturizing film (442), wherein the defibrillator second waterproof and moisturizing film (441) is sandwiched between the second male buckle face buckle (4301) and the second non-woven fabric layer (401); the cardiac electrode second waterproof and moisturizing film (442) is sandwiched between the second male buckle face buckle (4301) and the second non-woven fabric layer (401).

5. A wearable external defibrillator according to claim 4, characterized in that, The first conductive gel (25) includes a first defibrillator electrode conductive gel (251) and a first cardiac electrode conductive gel (252); the first defibrillator electrode male buckle (231) is provided with the first defibrillator electrode conductive gel (251) at the end away from the first defibrillator electrode female buckle (131); the first cardiac electrode male buckle (232) is provided with the first cardiac electrode conductive gel (252) at the end away from the first cardiac electrode female buckle (132); the projection of the defibrillator first waterproof and moisturizing film (241) on the first non-woven fabric layer (201) covers the first defibrillator electrode conductive gel (251) on the first non-woven fabric layer (201). The projection of the first waterproof and moisturizing membrane (242) of the cardiac electronic device on the first nonwoven fabric layer (201) covers the projection of the first cardiac electronic electrode conductive gel (252) on the first nonwoven fabric layer (201); the projection of the second waterproof and moisturizing membrane (441) of the defibrillator on the second nonwoven fabric layer (401) covers the projection of the second defibrillator electrode conductive gel (451) on the second nonwoven fabric layer (401); the projection of the second waterproof and moisturizing membrane (442) of the cardiac electronic device on the second nonwoven fabric layer (401) covers the projection of the second cardiac electronic electrode conductive gel (452) on the second nonwoven fabric layer (401).

6. A wearable external defibrillator according to claim 3, characterized in that, The base (12) has a plurality of first defibrillator female buckles (131), and the base (12) has the same number of first cardiac electronic electrode female buckles (132) as the first defibrillator female buckles (131); the RA defibrillator base (3) has a plurality of second defibrillator female buckles (331), and the RA defibrillator base (3) has the same number of second cardiac electronic electrode female buckles (332) as the second defibrillator female buckles (331).

7. A wearable external defibrillator according to claim 1, characterized in that, The first and second metal male and female buckle structures adopt magnetic male and female electrode buckles, spring clip male and female electrode buckles, or plug and socket type male and female electrode buckles.

8. A wearable external defibrillator according to claim 1, characterized in that, The wearable external defibrillator system includes: an energy storage battery module (90), a high-voltage charging drive and transformer module (97), a capacitor energy storage module (98), a circuit board module (100), a status monitoring circuit (LF), and a defibrillation treatment circuit; wherein, the energy storage battery module (90) is used to provide operating current to the status monitoring circuit (LF) and the high-voltage charging drive and transformer module (97); the high-voltage charging drive and transformer module (97) is used to charge the capacitor energy storage module (98); the capacitor energy storage module (98) is used to store energy and transmit electrical energy to the defibrillation treatment circuit; the circuit board module (100) is used to electrically connect other modules to each other; the defibrillation treatment circuit is used for defibrillation discharge; the status monitoring circuit (LF) is used to monitor real-time acquired data to determine whether defibrillation is needed and to control the discharge of the defibrillation treatment circuit.

9. A wearable external defibrillator according to claim 8, characterized in that, The status monitoring circuit (LF) includes: a low-voltage power conversion module (91), a low-voltage functional circuit and main control module (92), a speaker-ambient-MIC temperature and humidity sensor module (93), a body sensor module (94), a vibration warning module (95), and a button indicator module (96); the low-voltage power conversion module (91) is used to convert the output voltage of the energy storage battery module (90) and provide it to all other modules of the status monitoring circuit (LF); the low-voltage functional circuit and main control module (92) is used to determine whether the electrocardiogram signal collected by the body sensor module (94) is a defibrillable rhythm, and feeds the result back to the high-voltage charging drive and transformer module (97) and the defibrillation treatment circuit; the speaker-ambient-MIC temperature and humidity sensor module (93) is used to collect ambient sound and ambient humidity and The information is transmitted to the low-voltage function circuit and the main control module (92) and an alarm is sounded according to the signal of the low-voltage function circuit and the main control module (92); the vibration warning module (95) is used to issue a vibration warning according to the signal of the low-voltage function circuit and the main control module (92); the button indicator module (96) is used to issue an alarm light according to the signal of the low-voltage function circuit and the main control module (92) and cancel the false alarm by pressing the button; the defibrillation treatment circuit includes a high-voltage discharge biphasic bridge and drive module (99) and a high-voltage discharge variable resistor module (9A); the high-voltage discharge biphasic bridge and drive module (99) is used to perform biphasic wave discharge on the wearer through the detachable LL defibrillation electrode pad (2) and the detachable RA defibrillation electrode pad (4); the high-voltage discharge variable resistor module (9A) is used to adjust the defibrillation current in multiple segments.

10. A control method for a wearable external defibrillator according to any one of claims 8-9, characterized in that, Includes the following steps: Condition monitoring is performed via a condition monitoring circuit (LF). When the status monitoring circuit (LF) determines that defibrillation is required, it performs high-voltage charging on the capacitor energy storage module (98) by activating the high-voltage charging drive and transformer module (97); Electrical energy is transmitted to the defibrillation treatment circuit via the capacitor energy storage module (98).

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