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EP-4651792-B1 - A FULLY-DISPOSABLE ELECTROCARDIOGRAPH ECG RECORDER AND AN ECG MONITORING SYSTEM

EP4651792B1EP 4651792 B1EP4651792 B1EP 4651792B1EP-4651792-B1

Inventors

  • GAO, Linming
  • FAN, Zhequan
  • FU, Jianfa
  • HUANG, Huimei

Dates

Publication Date
20260513
Application Date
20240618

Claims (14)

  1. A fully-disposable electrocardiograph, ECG, recorder, comprising a flexible patch (1), configured to be attached to the surface of a human body, the flexible patch comprises an electric layer (12), the electric layer comprises a flexible electrical path (122) and at least two ECG electrodes (121), wherein the flexible electrical path is connected to the at least two ECG electrodes; a shell (2), forming a closed space; a signal processing unit (3), wherein the signal processing unit is located in the closed space; the flexible electrical path has a connecting end (122a), wherein the flexible patch is fixed on a bottom skin-facing side of the shell, wherein the bottom side has a first opening (216) for the connecting end to pass through; and the connecting end of the flexible electrical path extends upward into the closed space inside the shell, so as to be connected to the signal processing unit.
  2. The fully-disposable ECG recorder according to claim 1, wherein the flexible patch is provided with an adhesive patch layer (11), and the adhesive patch layer has a second opening (11c) corresponding to the first opening; the adhesive patch layer has a lower surface (11a) and an upper surface (11b), a part of the flexible electrical path is spread on the lower surface, and another part of the flexible electrical path is bent so as to enter the closed space through the second opening and the first opening.
  3. The fully-disposable ECG recorder according to any of claims 1 to 2, wherein the shell comprises a first shell part (21) and a second shell part (22).
  4. The fully-disposable ECG recorder according to claim 3, wherein the first shell part and the second shell part are separate shell parts, which are non-detachably connected with each other so as to form the closed space.
  5. The fully-disposable ECG recorder according to any of claims 1 to 4, wherein a reinforcing sheet (122f) is provided at the connecting end of the flexible electrical path.
  6. The fully-disposable ECG recorder according to any of claims 1 to 5, wherein the flexible patch is provided with a first adhesive layer (13), and the first adhesive layer covers the first opening, so as to ensure the closed space in the shell; preferably, the first adhesive layer covers at least a part of the flexible electrical path but does not cover any electrode.
  7. The fully-disposable ECG recorder according to any of claims 1 to 6, wherein the flexible patch is provided with a second adhesive layer (14), which is configured to adhere to the shell, so that the lower surface of the shell and the flexible patch are fixedly connected.
  8. The fully-disposable ECG recorder according to any of claims 3 to 7 when citing the claim 3, wherein a soft sealing ring (215) is arranged at the matching surface of the second shell part and the first shell part.
  9. The fully-disposable ECG recorder according to any of claims 1 to 8, wherein, after the connecting end of the flexible electrical path enters the closed space in the shell, the connecting end is bent multiple times and then connected to the signal processing unit.
  10. The fully-disposable ECG recorder according to any of claims 1 to 9, wherein the signal processing unit comprises an antenna (34), a limiting member (217) is provided in the shell, and the limiting member is used to limit the position of the antenna.
  11. The fully-disposable ECG recorder according to any of claims 1 to 10, wherein the fully-disposable ECG recorder further comprises an insulating pull tab (4); wherein the insulating pull tab preferably extends from the inside of the shell to the outside of the shell; wherein the insulating pull tab is able to be pulled out; wherein before being pulled out, the insulating pull tab is configured to interrupt or break the electrical connection, for example the electrical connection to or in the signal processing unit.
  12. The fully-disposable ECG recorder according to claim 11, wherein electrical connection with a spring contact or contacts is used, and the electrical connection with a spring contact or contacts is cut off by the insulating pull tab.
  13. The fully-disposable ECG recorder according to any of claims 1 to 12, wherein from top to bottom, the electric layer has a substrate layer (122b), an electrical path layer (122c), an isolation layer (122d), and a sticky layer (122e).
  14. An ECG monitoring system, comprising the ECG recorder according to any one of claims 1 to 13, and a server, configured to receive ECG data from the ECG recorder, wherein the server is configured to process the ECG data after receiving the ECG data from the ECG recorder.

Description

The present application claims the priority of the Chinese patent applications filed to the Chinese Patent Office on April 3, 2024, with application numbers 202410397461.0, 202420675540.9, 202410397757.2, 202420675819.7, 202420675683.X, and titled as "A fully-disposable ECG recorder and monitoring system", "A signal detecting device", "An ECG recorder", "A host structure and a signal detecting device", "A structure for signal acquisition and a patch of detecting device having the same", respectively. Technical Field The present invention relates to the field of wearable medical devices, and specifically to a fully-disposable electrocardiograph ECG recorder and an ECG monitoring system. Background Art Arrhythmia refers to abnormal frequency or rhythm of heart beats caused by abnormal cardiac activities in origin or in conduction. It belongs to an important group of cardiovascular diseases, which may occur alone or in conjunction with other cardiovascular diseases. Arrhythmia may cause various types of symptoms, however it is worth noting that not all patients with arrhythmia will show symptoms, and in some people, arrhythmias may be discovered only incidentally/occasionally during a physical exam or an ECG. For occasional arrhythmias, a rapid and reliable monitoring becomes difficult. Holter ECG monitoring is a common method for monitoring arrhythmia. It uses a dynamic ECG recorder to record the whole process of a patient's cardiac activity for 24 hours or longer in daily life, and then analyzes and processes the data with the help of a computer. This detecting method can capture arrhythmias and myocardial ischemia, which are not easy to be detected in a traditional ECG, and thus provide important objective basis for clinical diagnosis/treatment and judgment to evaluate the therapeutic efficacy. The current dynamic ECG recorder comprises a reusable module for recording physiological data, and a disposable flexible patch configured to be attached to human skin. This type of recorder is also called a semi-disposable ECG recorder or a split-type ECG recorder. The semi-disposable ECG recorder comprises a detachable recording module for physiological data, the recording module has electrical contacts to be connected to the flexible electrical path in the flexible patch. When in use, the recording module for physiological data is connected to the flexible patch, and the flexible patch is attached to the surface of human skin, so as to acquire, process and store ECG signals; after the signal acquisition is completed, the recording module for physiological data is taken out, and the doctor analyzes the data in the recording module; thereafter, the recording module can be disinfected for the next use. The above-mentioned semi-disposable ECG recorder needs a process of assembling the recording module with the flexible patch, a process of disassembling the recording module from the flexible patch, as well as a process of reusing the recording module. Thus, it will bring problems in use convenience and information security. Besides, the connection of electrical contacts between the recording module and the flexible patch will also bring potential risks in connection stability. In order to solve the problem of semi-disposable ECG recorders in use convenience, a fully-disposable ECG recorder, which can be completely discarded after use, is proposed. However, the fully-disposable ECG recorders in the prior art often have problems such as complex processes and a low yield rate in manufacturing. US2016/089049A1discloses a device for long term sensing and recording electrocardiogram, wherein the housing body includes an upper body and a lower body sealed to form an internal space for enclosing the processing circuit. The middle portion of the water-proof film is sandwiched between the upper body and the lower body. The flexible attach layer is beneath the water-proof film, and the electrodes penetrate the housing body to electrically connect the processing circuit. Summary of the disclosure The technical problem to be solved by the present disclosure is to overcome the problems of the semi-disposable ECG recorders in the prior art such as poor use convenience, poor information security, poor connection stability, etc., and to overcome the problems of the fully-disposable ECG recorders in the prior art such as complex processes and a low yield rate in manufacturing, and to provide a new fully-disposable ECG recorder. The present invention is set out in the appended set of claims. When the fully-disposable ECG recorder is attached to the human body, the lower side of the sticky layer is in contact with the human body. Optionally, an upper release film and a lower release film are provided on the upper and lower sides of the flexible patch, respectively. Optionally, the fully-disposable ECG recorder further comprises a battery, the signal processing unit comprises a circuit board and a chip on the circuit board, and the circuit