Subcutaneous continuous electrocardiogram monitoring system
The subcutaneous continuous ECG monitoring system with a measurement circuit formed by subcutaneous implantation electrodes solves the problem of insufficient monitoring and portability of existing equipment over a long time, and realizes convenient continuous ECG signal monitoring and early arrhythmia detection.
Patent Information
- Application Number
- CN202410024080.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-01-05
- Publication Date
- 2025-07-08
AI Technical Summary
Existing cardiovascular disease monitoring equipment has shortcomings in long-term monitoring and portability, making it difficult to continuously monitor short-term or infrequent arrhythmias, and implantable devices require surgery and have complications.
A subcutaneous continuous electrocardiogram monitoring system is designed to form a measuring circuit by implanting the first electrode and the second electrode subcutaneously in contact with the target tissue fluid, continuously monitor the electrocardiogram signal, and perform data processing and indication through the electronic module and terminal.
Convenient and continuous ECG signal monitoring is achieved, and the ability to detect and record short-term or infrequent arrhythmias can be timely detected and recorded, improving the portability of monitoring and diagnostic efficiency, and reducing surgical complications.
Smart Images
Figure CN120267296A_ABST
Abstract
Description
Technical Field
[0001] The present disclosure generally relates to the field of medical devices, and particularly to a subcutaneous continuous electrocardiogram monitoring system. Background Art
[0002] For cardiovascular diseases, early monitoring mainly focuses on capturing abnormal electrocardiogram data and timely performing medical intervention. However, during the latent period of cardiovascular diseases, it is very difficult to detect cardiovascular diseases through the external manifestations of patients. And usually, when the disease attacks, its suddenness makes it difficult for patients to receive timely treatment, resulting in a relatively high mortality rate.
[0003] The commonly used ambulatory electrocardiogram monitor is the 24-hour ambulatory electrocardiogram monitor (also known as the Holter electrocardiogram monitor). The Holter electrocardiogram monitor is a medical device that can continuously record the heart rhythm. During normal activities, the available time limit of the monitor is usually 24 to 48 hours. The Holter is of great significance for the diagnosis of patients with frequent symptoms. However, since the monitoring time of the Holter electrocardiogram monitor is not long enough, the diagnostic rate for patients with infrequent symptoms is relatively low. And due to the constraints of the electrodes, wires, and the connection with the device, the compliance of patients wearing the Holter electrocardiogram monitor during the whole process of physical activities is usually poor (for example, it cannot be worn during heavy physical activities, exercise, bathing, and swimming).
[0004] Another continuous dynamic electrocardiogram monitoring device is the insertable cardiac monitor (ICM), also known as the implantable loop recorder (ILR), which is a subcutaneous electrocardiogram monitoring device that can monitor arrhythmia for a long time (several months to several years) and automatically store and record electrocardiogram data. The diagnostic efficiency and recording time of the insertable cardiac monitor are better than those of traditional tools. However, the insertable cardiac monitor requires the patient to undergo surgery in the hospital and there are surgical complications. Summary of the Invention
[0005] The present disclosure is proposed in view of the above situation, and its purpose is to provide a subcutaneous continuous electrocardiogram monitoring system that can conveniently and continuously monitor electrocardiogram signal data and can detect and record transient or infrequently occurring arrhythmias.
[0006] To this end, the present disclosure provides a subcutaneous continuous electrocardiogram monitoring system, which is a monitoring system for measuring electrocardiogram signal data of a target, and includes a sensor module attached to the skin of the target, an electronic module coupled to the sensor module, and a terminal; the sensor module includes a first sensor module and a second sensor module, the first sensor module includes a first electrode, and the second sensor module includes a second electrode; the first electrode and the second electrode respectively have a distal portion implanted under the skin of the target and a proximal portion coupled to the electronic module; the distal portions of the first electrode and the second electrode are respectively configured to be inserted under the skin of the target to obtain the electrocardiogram signal data of the target, and the proximal portions of the first electrode and the second electrode are configured to transmit the electrocardiogram signal data to the electronic module; the terminal establishes a communication connection with the electronic module, and receives and indicates the electrocardiogram signal data from the electronic module, wherein the first electrode, the second electrode, and the electronic module form a measurement loop.
[0007] In the present disclosure, by implanting the first electrode and the second electrode under the skin of the target to contact the tissue fluid of the target, the electrocardiogram signal data can be measured, and a measurement loop can be formed, so that the electrocardiogram signal of the target can be continuously measured, and the electrocardiogram signal can be transmitted to the electronic module for processing. Furthermore, the electronic module can transmit the obtained electrocardiogram signal to the terminal to indicate the electrocardiogram signal data of the target on the terminal. Thus, the electrocardiogram signal data of the target can be conveniently and continuously monitored.
[0008] In addition, in the subcutaneous continuous electrocardiogram monitoring system according to the present disclosure, optionally, the distal portions of the first electrode and the second electrode respectively extend at a preset angle deviating from the horizontal direction to form the preset angle with the horizontal direction. Thus, the volumes of the first sensor module and the second sensor module can be reduced, thereby improving the convenience of use of the subcutaneous continuous electrocardiogram monitoring system.
[0009] In addition, in the subcutaneous continuous electrocardiogram monitoring system according to the present disclosure, optionally, the first sensor module includes a first housing, the second sensor module includes a second housing, the first electrode is detachably connected to the first housing, the second electrode is detachably connected to the second housing, and removable adhesive substances are respectively provided on the third bottom surface of the electronic module, the first bottom surface of the first housing, and the second bottom surface of the second housing. In this case, it is convenient to install the first electrode and the second electrode on the first sensor module and the second sensor module. In addition, the first sensor module, the second sensor module, and the electronic module can be attached to the skin layer of the target by the removable adhesive substances. Thus, the convenience of the subcutaneous continuous electrocardiogram monitoring system can be improved.
[0010] In addition, in the subcutaneous continuous ECG monitoring system involved in the present disclosure, optionally, the distal portion of the first electrode includes a first conductive portion implanted under the skin of the target, the proximal portion of the first electrode includes a first electrical contact coupled to the electronic module, the distal portion of the second electrode includes a second conductive portion implanted under the skin of the target, and the proximal portion of the second electrode includes a second electrical contact coupled to the electronic module. In this case, the first conductive portion and the second conductive portion can respectively contact the tissue fluid of the target, so that the ECG signal in the tissue fluid of the target can be sensed and can be transmitted to the electronic module through the first electrical contact and the second electrical contact, respectively.
[0011] In addition, in the subcutaneous continuous ECG monitoring system of the present disclosure, optionally, the first conductive part and the second conductive part are made of rare metals. In this case, rare metals generally have good electrical conductivity, high corrosion resistance, low resistance, and are lightweight, which is conducive to improving the characteristics and portability of the electrode.
[0012] In addition, in the subcutaneous continuous ECG monitoring system of the present disclosure, optionally, the first sensor module includes a first support body provided in the first housing, and the second sensor module includes a second support body provided in the second housing, the first electrode is detachably connected to the first support body, and the second electrode is detachably connected to the second support body. Thus, the installation and removal of the first electrode and the second electrode are facilitated.
[0013] In addition, in the subcutaneous continuous ECG monitoring system involved in the present disclosure, optionally, the first support body includes a first support and a first pressing portion, the second support body includes a second support and a second pressing portion, the first pressing portion presses the proximal portion of the first electrode onto the first support, and the second pressing portion presses the proximal portion of the second electrode onto the second support. In this case, the first pressing portion and the first support can surround and press the proximal portion of the first electrode to form a sealing structure, thereby reducing the impact of humid water vapor or other contaminants on the proximal portion of the first electrode, and similarly, the second support and the second pressing portion can also reduce the impact of humid water vapor or other contaminants on the proximal portion of the second electrode.
[0014] In addition, in the subcutaneous continuous ECG monitoring system involved in the present disclosure, optionally, a positioning device is included, and the positioning device is used to make the distance between the first sensor module and the second sensor module on the skin of the target within a preset range. In this case, the distance between the first sensor module and the second sensor module can be within a preset range, so that the distance between the first sensor module and the second sensor module meets the measurement requirements, thereby obtaining ECG signal data at a predetermined position.
[0015] In addition, in the subcutaneous continuous electrocardiogram monitoring system involved in the present disclosure, optionally, the first electrode and the second electrode each include a biocompatible material. Thereby, the immune response of the subject to the first electrode and the second electrode can be inhibited, and the service life of the first electrode and the second electrode can be extended.
[0016] In addition, in the subcutaneous continuous electrocardiogram monitoring system involved in the present disclosure, optionally, the first electrode is the positive electrode and the second electrode is the negative electrode. In this case, the first electrode, that is, the measuring electrode, can obtain the electrocardiogram signal data of the subject; the second electrode, that is, the reference electrode, can provide a reference potential, thereby enabling the measurement of the voltage difference between the positive electrode and the negative electrode. Thus, when the heart contracts and relaxes, the electrical signals in the myocardial cells change, and the first electrode and the second electrode can form a measurement circuit, so that the electrocardiogram signal data can be measured.
[0017] According to the present disclosure, a subcutaneous continuous electrocardiogram monitoring system can be provided, which can conveniently and continuously monitor electrocardiogram signal data and can detect and record transient or infrequent arrhythmias. Brief Description of the Drawings
[0018] The present disclosure will now be further explained in detail only by way of examples with reference to the accompanying drawings, where:
[0019] Figure 1A is an application scenario diagram showing the subcutaneous continuous electrocardiogram monitoring system involved in the example of the present disclosure.
[0020] Figure 1B is an application scenario diagram showing another view direction of the subcutaneous continuous electrocardiogram monitoring system involved in the example of the present disclosure.
[0021] Figure 2A is a schematic diagram showing the subcutaneous continuous electrocardiogram monitoring system involved in the example of the present disclosure.
[0022] Figure 2B is a schematic diagram showing another view direction of the subcutaneous continuous electrocardiogram monitoring system involved in the example of the present disclosure.
[0023] Figure 3A is a schematic diagram showing the first electrode involved in the example of the present disclosure.
[0024] Figure 3B is a schematic diagram showing another view of the first electrode involved in the example of the present disclosure.
[0025] Figure 3C is a schematic diagram showing the second electrode involved in the example of the present disclosure.
[0026] Figure 4AIt is a schematic diagram showing the internal composition of the first sensing module involved in the examples of the present disclosure.
[0027] Figure 4B It is a schematic diagram showing the cooperation between the first electrode and the first support body involved in the examples of the present disclosure.
[0028] Figure 4C It is a schematic diagram showing the state after the first electrode and the first support body involved in the examples of the present disclosure are assembled.
[0029] Figure 4D It is a schematic diagram showing the first conductive column involved in the examples of the present disclosure.
[0030] Figure 5A It is a schematic diagram showing the internal composition of the second sensing module involved in the examples of the present disclosure.
[0031] Figure 5B It is a schematic diagram showing the cooperation between the second electrode and the second support body involved in the examples of the present disclosure.
[0032] Figure 5C It is a schematic diagram showing the state after the second electrode and the second support body involved in the examples of the present disclosure are assembled.
[0033] Figure 5D It is a schematic diagram showing the second conductive column involved in the examples of the present disclosure.
[0034] Figure 6A It is a schematic diagram showing the first guiding needle located in the first sensor module involved in the examples of the present disclosure.
[0035] Figure 6B It is a sectional view of the first guiding needle in the B-B direction involved in the examples of the present disclosure.
[0036] Figure 6C It is a sectional view of another embodiment of the first guiding needle in the B-B direction involved in the examples of the present disclosure.
[0037] Figure 6D It is a schematic diagram showing the cooperation between the first guiding needle and the first electrode involved in the examples of the present disclosure.
[0038] Figure 6E It is a schematic diagram showing the first guiding needle support involved in the examples of the present disclosure.
[0039] Figure 6F It is a schematic diagram showing the first guiding needle piercing into the skin layer involved in the examples of the present disclosure.
[0040] Figure 6G It is a schematic diagram showing the first guiding needle withdrawing from the first sensor module involved in the examples of the present disclosure.
[0041] Figure 7A It is a schematic diagram showing the second guiding needle involved in the examples of the present disclosure located in the second sensor module.
[0042] Figure 7B It is a schematic diagram showing another view direction of the second guiding needle involved in the examples of the present disclosure located in the second sensor module.
[0043] Figure 7C It is a schematic diagram showing the cooperation between the second guiding needle and the second electrode involved in the examples of the present disclosure.
[0044] Figure 7D It is a schematic diagram showing the second guiding needle support involved in the examples of the present disclosure.
[0045] Figure 7E It is a schematic diagram showing the second guiding needle piercing into the skin layer involved in the examples of the present disclosure.
[0046] Figure 7F It is a schematic diagram showing the second guiding needle withdrawing from the second sensor module involved in the examples of the present disclosure.
[0047] Figure 8 It is a schematic diagram showing the positioning device involved in the examples of the present disclosure.
[0048] Figure 9A It is a schematic diagram showing the data processing unit involved in the examples of the present disclosure.
[0049] Figure 9B It is a block diagram showing the composition of the data processing unit involved in the examples of the present disclosure.
[0050] Figure 10 It is a schematic diagram showing another embodiment of the subcutaneous continuous electrocardiogram monitoring system involved in the examples of the present disclosure. Detailed implementation manners
[0051] Next, the technical solutions in the embodiments of the present disclosure will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present disclosure. Obviously, the described embodiments are only a part of the embodiments of the present disclosure, rather than all the embodiments. Based on the embodiments in the present disclosure, all other embodiments filled by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present disclosure.
[0052] It should be noted that the terms "first", "second", "third", "fourth", etc. in the description, claims and the above-mentioned drawings of the present disclosure are used to distinguish different objects, rather than to describe a specific order. It should be noted that the terms "comprising" and "having" in the present disclosure and any variations thereof, for example, a process, method, system, product or device including or having a series of steps or units do not necessarily have to be limited to those steps or units clearly listed, but may include or have other steps or units not clearly listed or inherent to these processes, methods, products or devices.
[0053] Hereinafter, with reference to the drawings, the preferred embodiments of the present disclosure will be described in detail. In the following description, the same reference numerals are given to the same components, and repeated descriptions are omitted. In addition, the drawings are only schematic diagrams, and the proportional relationship of the sizes between components or the shapes of components, etc. may be different from the actual ones.
[0054] In the present disclosure, unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense. For example, "connection" can be a fixed connection, a detachable connection, or integrated; it can be directly connected or indirectly connected through an intermediate medium. In addition, the term "coupling" can be a way of realizing electrical connection for signal transmission. "Coupling" can be a direct electrical connection (electrical connection is also called electrical connection), or an indirect electrical connection through an intermediate medium.
[0055] The contraction and relaxation of the heart are caused by electrical signals in cardiomyocytes, and the propagation of these electrical signals can be monitored by subcutaneously inserting electrodes. The present disclosure provides a subcutaneous continuous electrocardiogram monitoring system. The electrodes of the subcutaneous continuous electrocardiogram monitoring system can be inserted under the skin of a target and come into contact with the subcutaneous tissue fluid to obtain the electrocardiogram signal of the target. Compared with traditional surface electrocardiogram monitoring, subcutaneous electrocardiogram monitoring can provide a longer time and continuous evaluation of cardiac electrical activity. It can detect and record transient or infrequent arrhythmias, such as atrial fibrillation, ventricular fibrillation or ventricular tachycardia, which may not be captured in a short traditional electrocardiogram test, so as to be able to identify abnormal electrocardiogram data of the target early through electrocardiogram signal data, so as to reduce the risk of major diseases related to the target and cardiovascular system. In the present disclosure, tissue fluid can also be called interstitial fluid, which is the fluid existing between cells.
[0056] In the present disclosure, a subcutaneous continuous electrocardiogram (ECG) monitoring system is a monitoring system used to measure the ECG signal data of a target, and can also be referred to as a tissue fluid ECG monitoring system or a portable ECG monitoring system. The target can be referred to as an object, a user, a patient, or a sufferer. The cardiac electrical signal, the ECG signal data, and the ECG signal can all refer to the target's ECG signal. In some examples, the target's ECG signal can include an analog signal (e.g., voltage or amperage). In some examples, the target's ECG signal can include digital data in the form of "counts" converted from the analog signal.
[0057] Figure 1A FIG. 4 is an application scenario diagram showing the subcutaneous continuous ECG monitoring system 10 involved in the examples of the present disclosure. Figure 1B FIG. 6 is an application scenario diagram showing another view direction of the subcutaneous continuous ECG monitoring system 10 involved in the examples of the present disclosure. Figure 2A FIG. 8 is a schematic diagram showing the subcutaneous continuous ECG monitoring system 10 involved in the examples of the present disclosure. Specifically, Figure 2A FIG. 10 shows the layout of the top surface of the subcutaneous continuous ECG monitoring system 10. Figure 2B FIG. 12 is a schematic diagram showing another view direction of the subcutaneous continuous ECG monitoring system 10 involved in the examples of the present disclosure. Specifically, Figure 2B FIG. 14 shows the layout of the bottom surface of the subcutaneous continuous ECG monitoring system 10.
[0058] In some examples, referring to Figure 1A and Figure 1B , the subcutaneous continuous ECG monitoring system 10 can be applied to the chest of the target. Preferably, the subcutaneous continuous ECG monitoring system 10 can be applied to the left chest, that is, near the target's heart. In this case, the electrical signals generated by the heart can be accurately sensed by the subcutaneous continuous ECG monitoring system 10, so that abnormal ECG data can be detected.
[0059] It should be noted that the present disclosure does not limit the specific implantation position of the subcutaneous continuous ECG monitoring system 10. For example, the subcutaneous continuous ECG monitoring system 10 can also be implanted in body positions such as the arm, the leg, and the back.
[0060] In some examples, referring to Figure 2A , the subcutaneous continuous ECG monitoring system 10 can include a sensor module 20 applied to the skin of the target. The sensor module 20 can be used to measure the ECG signal data of the target.
[0061] In some examples, the subcutaneous continuous ECG monitoring system 10 can further include an electronic module 30 coupled to the sensor module 20. In this case, the electronic module 30 can receive and process the ECG signal data measured by the sensor module 20.
[0062] In some examples, the subcutaneous continuous electrocardiogram monitoring system 10 may further include a terminal 40 (see Figure 1A and Figure 1B ).
[0063] In some examples, the terminal 40 may establish a communication connection with the electronic module 30 and receive and indicate the target electrocardiogram signal data from the electronic module 30.
[0064] In the present disclosure, "indicate" should be understood in a broad sense. For example, indicating may be to display the target electrocardiogram signal data through various graphs or numbers, or to indicate or broadcast the target electrocardiogram signal data through an auditory signal.
[0065] In some examples, the communication link 70 may be a duplex communication. In other words, the terminal 40 may receive data from the electronic module 30. For example, the terminal 40 may receive electrocardiogram signal data from the electronic module 30; the terminal 40 may also send data to the electronic module 30. For example, the terminal 40 may send a control instruction to the electronic module 30.
[0066] In some examples, the communication link 70 may be a wired communication method.
[0067] In some examples, the communication link 70 may be a wireless communication method, which may include but is not limited to at least one of Bluetooth, Wifi, 3G / 4G / 5G, NFC, UWB, and Zig-Bee.
[0068] In some examples, the terminal 40 may include a display unit 41, and the display unit 41 may display the target electrocardiogram signal data in a visual and / or auditory form. Thus, it is possible to facilitate timely understanding of the target's cardiac activity status.
[0069] In some examples, the terminal 40 may include an input unit 42. Thus, the terminal 40 can output an operation instruction through the input unit 42, and then perform a control operation on the electronic module 30.
[0070] In some examples, the terminal 40 may include an alarm unit, and the alarm unit may generate an alarm message. In some examples, the alarm message may include an auditory and / or visual alarm message. In some examples, the alarm message may include a tactile alarm message, for example, it may include vibration information. In this case, when the target electrocardiogram signal data exceeds a reasonable range, an alarm message can be generated to prompt the target or the user.
[0071] In some examples, the terminal 40 may be a personal computer (such as a desktop computer or a tablet computer), a personal smart terminal (such as a smart mobile phone), or a remote server.
[0072] In some examples, see Figure 2A, the sensor module 20 may include a first sensor module 21 and a second sensor module 22. In some examples, the first sensor module 21 and the second sensor module 22 may form a measurement loop. Thus, the first sensor module 21 and the second sensor module 22 can form a measurement loop to sense the target's electrocardiogram signal.
[0073] In some examples, referring to Figure 2A , the first sensor module 21 may include a third terminal 213. In some examples, the second sensor module 22 may include a fourth terminal 223.
[0074] In some examples, referring to Figure 2A , the electronic module 30 may include a first terminal 311 and a second terminal 312.
[0075] In some examples, the first terminal 311 and the third terminal 213 may be coupled by a first signal line 50a. In some examples, the second terminal 312 and the fourth terminal 223 may be coupled by a second signal line 50b.
[0076] In some examples, referring to Figure 2B , the first sensor module 21 may include a first electrode 211. In this case, the first electrode 211 can be inserted under the target's skin to measure the cardiac electrical signal.
[0077] In the present disclosure, "under the skin" may also be referred to as "skin layer".
[0078] In some examples, the first electrode 211 may extend out of the first bottom surface 2122 of the first sensor module 21.
[0079] In some examples, referring to Figure 2B , the second sensor module 22 may include a second electrode 221.
[0080] In some examples, the second electrode 221 may extend out of the second bottom surface 2222 of the second sensor module 22.
[0081] In some examples, the first electrode 211, the second electrode 221, and the electronic module 30 may form a measurement loop.
[0082] In some examples, the first electrode 211 can be the positive electrode, and the second electrode 221 can be the negative electrode, that is, the positive electrode can be the measurement electrode and the negative electrode can be the reference electrode. In this case, the first electrode 211, that is, the measurement electrode, can obtain the target electrocardiogram signal data; the second electrode 221, that is, the reference electrode, can provide a reference potential, thereby enabling the measurement of the voltage difference between the positive and negative electrodes. Thus, when the heart contracts and relaxes, the electrical signals in the myocardial cells change, and the first electrode 211 and the second electrode 221 can form a measurement circuit, thereby enabling the measurement of electrocardiogram signal data.
[0083] In some examples, the first electrode 211 can also be the negative electrode, and the second electrode 221 can also be the positive electrode.
[0084] In some examples, the first electrode 211 and the second electrode 221 can be completely identical electrodes. Thus, when measuring the electrocardiogram signal, the first electrode 211 and the second electrode 221 can maintain consistency.
[0085] In some examples, the first sensor module 21 can include a first housing 212 and a removable adhesive substance can be provided on the first bottom surface 2122. Thus, the first sensor module 21 can be attached to the target skin layer.
[0086] In some examples, the second sensor module 22 can include a second housing 222 and a removable adhesive substance can be provided on the second bottom surface 2222. Thus, the second sensor module 22 can be attached to the target skin layer.
[0087] In some examples, the electronic module 30 can include a housing 31. In some examples, a removable adhesive substance can be provided on the third bottom surface 313 of the housing 31. Thus, the electronic module 30 can be attached to the target skin layer.
[0088] In some examples, the removable adhesive substance can be a polyester or acrylic-based adhesive or any other biocompatible material, and a suitable material that provides sufficient bonding strength.
[0089] In some examples, the first housing 212 can be provided with a first recess 2123. This facilitates the flatness of the connection between the third terminal 213 and the first signal line 50a, and can enhance the reliability of the connection.
[0090] In some examples, the second housing 222 can also be provided with a second recess 2223.
[0091] In the present disclosure, the first sensor module 21 and the second sensor module 22 may include the same components and have the same structure and functions. For the sake of simplicity of description, the first sensor module 21 will be introduced in detail below, and the composition and structure of the second sensor module 22 may refer to the description of the first sensor module 21.
[0092] Figure 3A It is a schematic diagram showing the first electrode 211 involved in the example of the present disclosure. Figure 3B It is a schematic diagram showing another view of the first electrode 211 involved in the example of the present disclosure. Figure 3C It is a schematic diagram showing the second electrode 221 involved in the example of the present disclosure.
[0093] In some examples, the first electrode 211 may include a first distal portion 2111 and a first proximal portion 2112.
[0094] In some examples, the first distal portion 2111 and the first proximal portion 2112 may be in a coupled relationship. In some examples, a conductive trace or a conductive layer may be provided on the first electrode 211. Thus, the first distal portion 2111 and the first proximal portion 2112 can be formed in a coupled relationship.
[0095] In some examples, the first distal portion 2111 may be implanted under the skin of the target to obtain electrocardiogram signal data of the target. Thus, the first electrode 211 can be in direct contact with the tissue fluid of the target, and relatively accurate electrocardiogram signal data can be obtained.
[0096] In some examples, the first proximal portion 2112 may be coupled to the electronic module 30. In this case, the electrocardiogram signal data measured by the first distal portion 2111 can be transmitted to the electronic module 30 through the first proximal portion 2112.
[0097] In some examples, the first distal portion 2111 may include a first conductive portion 21111 implanted under the skin of the target (see Figure 3A ). Thus, the first conductive portion 21111 can be in contact with the tissue fluid of the target, so that the electrocardiogram signal in the tissue fluid of the target can be sensed.
[0098] In some examples, the first conductive portion 21111 may be made of a metal material. In some examples, the first conductive portion 21111 may be made of a rare metal. In this case, the rare metal usually has good electrical conductivity, high corrosion resistance, low resistance, and the characteristic of light weight. Thus, it is beneficial to improve the electrical conductivity, corrosion resistance and portability of the electrode.
[0099] In some examples, the first conductive portion 21111 may be made of any one selected from gold, glassy carbon, graphite, silver, silver chloride, palladium, titanium, and iridium. In this case, the first conductive portion 21111 can have good electrical conductivity and can inhibit the occurrence of electrochemical reactions in the first conductive portion 21111, thereby improving the stability of the first conductive portion 21111.
[0100] In some examples, the first electrode 211 may include a biocompatible material. In some examples, the entire first electrode 211 may be covered with a biocompatible material.
[0101] In some examples, only the first distal portion 2111 may be covered and wrapped with a biocompatible material.
[0102] In some examples, the first proximal portion 2112 may include a first electrical contact 21121. In this case, the target electrocardiogram signal data can be transmitted outward through the first electrical contact 21121. In some examples, the first electrical contact 21121 may be coupled to the electronic module 30. In some examples, the first electrical contact 21121 may be coupled to the third terminal 213.
[0103] In some examples, the first electrical contact 21121 may include at least one. In some examples, the first electrical contact 21121 may include three. For example, referring to Figure 3A , the first electrical contact 21121 may include a first electrical contact 21121a, a first electrical contact 21121b, and a first electrical contact 21121c. In this case, in practical applications, only one electrical contact is required to work. By providing multiple electrical contacts, a backup signal path can be formed to improve reliability.
[0104] In some examples, the first electrical contact 21121 may be coupled to the first conductive portion 21111 in the form of a hole (see Figure 3A ). In this case, the first conductive post 214 (described later) can penetrate the hole that serves as the first electrical contact 21121, thereby facilitating the stable connection of the first electrode 211 to the first housing 212.
[0105] In some examples, referring to Figure 3B , the first distal portion 2111 may extend at a preset angle A deviating from the horizontal direction T to form a preset angle A with the horizontal direction. Thereby, the volume of the first sensor module 21 can be reduced, and thus the convenience of using the subcutaneous continuous electrocardiogram monitoring system 10 can be improved.
[0106] In some examples, the preset angle A can be greater than or equal to 80 degrees and less than or equal to 90 degrees. In some examples, the second electrode 221 can be the same as the first electrode 211. The above description of the first electrode 211 also applies to the second electrode 221.
[0107] Specifically, referring to Figure 3C , in some examples, the second electrode 221 can include a second distal portion 2211 and a second proximal portion 2212.
[0108] In some examples, the second distal portion 2211 and the second proximal portion 2212 can be in a coupled relationship. In some examples, a conductive trace or a conductive layer can be provided on the second electrode 221.
[0109] In some examples, the second distal portion 2211 can be implanted under the skin of the target to obtain electrocardiogram signal data of the target.
[0110] In some examples, the second proximal portion 2212 can be coupled to the electronic module 30. In this case, the electrocardiogram signal data of the target measured by the second distal portion 2211 can be transmitted to the electronic module 30 through the second proximal portion 2212.
[0111] In some examples, the second distal portion 2211 can include a second conductive part 22111 implanted in the skin layer of the target (refer to Figure 3C ). In some examples, the second conductive part 22111 can be made of a metal material. In some examples, the second conductive part 22111 can be made of a rare metal. In some examples, the second conductive part 22111 can be made of at least one selected from gold, glassy carbon, graphite, silver, silver chloride, palladium, titanium, and iridium.
[0112] In some examples, the second electrode 221 can include a biocompatible material. In some examples, the entire second electrode 221 can be covered with a biocompatible material.
[0113] In some examples, only the distal portion 2111 of the second electrode 221 can be covered and wrapped with a biocompatible material.
[0114] In some examples, the biocompatible material can be made of a plant material. The plant material can be sodium alginate, tragacanth gum, pectin, gum arabic, xanthan gum, guar gum, agar, etc. or derivatives of natural materials. Among them, the derivatives of natural materials can include: starch derivatives and cellulose derivatives, etc.
[0115] In some other examples, the biocompatible material can also be made of synthetic materials. The synthetic materials can be polyolefins: povidone, polyvinyl alcohol, polyisobutylene pressure-sensitive adhesive, ethylene-vinyl acetate copolymer, etc.; or polyacrylic acids: acrylic resin, carboxyvinyl-sucrose, carboxyvinyl-pentaerythritol copolymer, polyacrylate pressure-sensitive adhesive, etc.; or polyoxyethylenes: polyoxyethylene fatty acid ester, polyoxyethylene-polyoxypropylene copolymer, etc. Polyesters: polylactic acid, polyglycolide-lactide, poly(nonyl sebacate), polycyanoalkyl amino ester, polyether polyurethane, etc. Thus, the immune response to the target counter electrode can be inhibited, and the service life of the electrode can be extended.
[0116] In some examples, the second proximal portion 2212 can include a second electrical contact 22121. In this case, the target electrocardiogram signal data can be transmitted outward through the second electrical contact 22121. In some examples, the second electrical contact 22121 can be coupled to the electronic module 30. In some examples, the second electrical contact 22121 can be coupled to the fourth terminal 223.
[0117] In some examples, there can be three second electrical contacts 22121. For example, referring to Figure 3C , the second electrical contact 22121 can include a second electrical contact 22121a, a second electrical contact 22121b, and a second electrical contact 22121c.
[0118] In some examples, the second electrical contact 22121 can be coupled to the second conductive portion 22111 in the form of a hole.
[0119] In some examples, similarly, the second distal portion 2211 can also extend at a preset angle A deviating from the horizontal direction T to form a preset angle A with the horizontal direction T. In some examples, the preset angle A can be greater than or equal to 80 degrees and less than or equal to 90 degrees.
[0120] Figure 4A is a schematic diagram showing the internal composition of the first sensing module 21 involved in the examples of the present disclosure. Figure 4B is a schematic diagram showing the cooperation between the first electrode 211 and the first support 215 involved in the examples of the present disclosure. Figure 4C is a schematic diagram showing the state after the first electrode 211 and the first support 215 are assembled in the examples of the present disclosure. Figure 4D is a schematic diagram showing the first conductive post 214 involved in the examples of the present disclosure.
[0121] In some examples, the first electrode 211 can be detachably connected to the first housing 212 (see Figure 2A ).
[0122] In some examples, see Figure 4A, the first sensor module 21 may include a first support body 215 disposed in a first housing 212 (see Figure 2A ), and the first electrode 211 may be detachably connected to the first support body 215, that is, the first electrode 211 may be detachably connected to the first housing 212. Thus, the installation and fixation of the first electrode 211 can be facilitated.
[0123] In some examples, the first support body 215 may be made of an elastic material, such as silicone resin, silicone resin-polyurethane mixture, polyurethane, and polysulfide. Thus, the elastic first support body 215 can form a buffer protection for the first electrode 211.
[0124] In some examples, the first support body 215 may include a first support 2151 and a first pressing portion 2152. Specifically, referring to Figure 4B and 4C , where Figure 4B shows an exploded view of the first pressing portion 2152, the first support 2151, and the first electrode 211. It can be seen through Figure 4B that the first pressing portion 2152 can press the first proximal portion 2112 of the first electrode 211 against the first support 2151. In this case, the first pressing portion 2152 and the first support 2151 can surround and press the first proximal portion 2112 to form a sealing structure. Figure 4C shows the situation after the first pressing portion 2152, the first support 2151, and the first electrode 211 are assembled. Thus, the influence of moist water vapor or other contaminants on the first proximal portion 2112 can be reduced.
[0125] In some examples, the first sensor module 21 may include a first conductive post 214, and the first conductive post 214 may be coupled to a first electrical contact 21121 (see Figure 4D ).
[0126] In some examples, referring to Figure 4A and Figure 4D , the first conductive post 214 may also include three, for example, it may include a first conductive post 214a, a first conductive post 214b, and a first conductive post 214c. Thus, it can be coupled to the three first electrical contacts 21121 of the first electrode 211 respectively in a one-to-one correspondence.
[0127] In some examples, referring to Figure 4D , the first conductive post 214 may be coupled to a third connection terminal 213 through a first substrate 216 provided with conductive traces. For example, the first substrate 216 may be a printed circuit board, and conductive traces connecting the first conductive post 214 and the third connection terminal 213 may be provided on the printed circuit board. Thus, the coupling of the first electrode 211 and the third connection terminal 213 can be achieved.
[0128] In some examples, the first conductive post 214 can also be coupled to the third terminal 213 through a conductive wire. Thus, when the first substrate 216 is not a printed circuit board, the first conductive post 214 and the third terminal 213 can be coupled through a simple conductive wire.
[0129] In some examples, the third terminal 213 can be coupled to the first electrical contact 21121 through the first conductive post 214.
[0130] In some examples, the first conductive post 214 can be detachably and hermetically disposed in the first support 2151 (see Figure 4B ). Thus, the influence of humid water vapor or other pollutants on the first conductive post 214 can be reduced.
[0131] In the present disclosure, the second sensor module 22 can have the same composition and structure as the first sensor module 21. The second sensor module 22 will be simply described below, and the specific functions and operations can refer to the description of the first sensor module 21.
[0132] Figure 5A FIG. is a schematic diagram showing the internal composition of the second sensing module 22 according to the examples of the present disclosure. Figure 5B FIG. is a schematic diagram showing the cooperation between the second electrode 221 and the second support 225 according to the examples of the present disclosure. Figure 5C FIG. is a schematic diagram showing the state after the second electrode 221 and the second support 225 are assembled according to the examples of the present disclosure. Figure 5D FIG. is a schematic diagram showing the second conductive post 224 according to the examples of the present disclosure.
[0133] In some examples, the second electrode 221 can be detachably connected to the second housing 222 (see Figure 2A ).
[0134] In some examples, see Figure 5A , the second sensor module 22 can include a second support 225 disposed in the second housing 222 (see Figure 2A ), and the second electrode 221 can be detachably connected to the second support 225, that is, the second electrode 221 can be detachably connected to the second housing 222.
[0135] In some examples, the second support 225 can be made of an elastic material, such as at least one of silicone resin, silicone resin-polyurethane mixture, polyurethane, and polysulfide.
[0136] In some examples, the second support 225 can include a second support 2251 and a second pressing portion 2252 (see Figure 5B andFigure 5C ),the second pressing part 2252 can press the second proximal part 2212 of the second electrode 221 against the second support 2251.
[0137] In some examples, the second sensor module 22 may include a second conductive post 224, and the second conductive post 224 may be coupled to the second electrical contact 22121 (see Figure 5A ).
[0138] In some examples, see Figure 5B , the second conductive post 224 may also include three, for example, it may include a second conductive post 224a, a second conductive post 224b, and a second conductive post 224c.
[0139] In some examples, the second conductive post 224 may be detachably and hermetically disposed in the second support 2251.
[0140] In some examples, see Figure 5D , the second conductive post 224 may be coupled to the fourth terminal 223 through a second substrate 226 provided with conductive traces. For example, the second substrate 226 may be a printed circuit board, and conductive traces connecting the second conductive post 224 and the fourth terminal 223 may be provided on the printed circuit board.
[0141] In some examples, the second conductive post 224 may also be coupled to the fourth terminal 223 through a conductive wire.
[0142] In some examples, the fourth terminal 223 may be coupled to the second electrical contact 22121 through the second conductive post 224.
[0143] Figure 6A is a schematic diagram showing the first guiding needle 217 involved in the examples of the present disclosure located in the first sensor module 21. Figure 6B is a cross-sectional view of the first guiding needle 217 involved in the examples of the present disclosure in the B-B direction. Figure 6C is a cross-sectional view of another embodiment of the first guiding needle 217 involved in the examples of the present disclosure in the B-B direction. Figure 6D is a schematic diagram showing the cooperation between the first guiding needle 217 and the first electrode 211 involved in the examples of the present disclosure. Figure 6E is a schematic diagram showing the first guiding needle support 218 involved in the examples of the present disclosure. Figure 6F is a schematic diagram showing the first guiding needle 217 piercing the skin layer involved in the examples of the present disclosure. Figure 6G is a schematic diagram showing the first guiding needle 217 withdrawing from the first sensor module 21 involved in the examples of the present disclosure. In Figure 6F and Figure 6G , the shaded part represents the skin layer.
[0144] In some examples, referring to Figure 6A , the subcutaneous continuous electrocardiogram monitoring system 10 may further include a first guiding needle 217 disposed on the first housing 212. Thus, it is convenient to use the first guiding needle 217 to implant the first electrode 211 into the target skin layer (refer to Figure 6D ).
[0145] In some examples, the first housing 212 may include a first top surface 2121 and a first bottom surface 2122 (refer to Figure 2A and Figure 2B ). In this case, the first top surface 2121 and the first bottom surface 2122 can form an accommodation space.
[0146] In some examples, the first top surface 2121 and the first bottom surface 2122 may be respectively provided with openings.
[0147] In some examples, the first sharp portion 2172 of the first guiding needle 217 may be configured to extend along the longitudinal axis T1 (refer to Figure 6A ) through the opening of the first top surface 2121 and the opening of the first bottom surface 2122. In this case, the first guiding needle 217 can be advanced through the opening of the first top surface 2121 and the opening of the first bottom surface 2122 to pierce the target skin layer (refer to Figure 6F ) or withdrawn from the target skin layer to be separated from the first sensor module 21 (refer to 6G).
[0148] In some examples, the first guiding needle 217 may have a hollow first sharp portion 2172, that is, the first sharp portion 2172 has an accommodation space, and the first distal portion 2111 of the first electrode 211 may be disposed within the first sharp portion 2172 of the first guiding needle 217. In this case, the first guiding needle 217 can pierce the target skin layer to facilitate implanting the first distal portion 2111 of the first electrode 211 into the target skin layer.
[0149] In some examples, referring to Figure 6B , the first sharp portion 2172 may have a groove, and the first distal portion 2111 of the first electrode 211 may be disposed within the groove. In some examples, the groove of the first sharp portion 2172 may include a first edge 2172a and a second edge 2172b and a third edge 2172b that is substantially perpendicular to the first edge 2172a and the second edge 2172b (refer to Figure 6B ). In some examples, the groove of the first sharp portion 2172 may be arc-shaped (refer to Figure 6C ).
[0150] In some examples, the first guiding needle 217 may include a first head 2171 (refer to Figure 6D) Thus, it is convenient to move the first guiding needle 217 by clamping the first head 2171.
[0151] In some examples, referring to Figure 6E , the first housing 212 may be provided with a first guiding needle support 218. The first guiding needle support 218 may have a first through hole 2181. The first guiding needle 217 may penetrate through the first through hole 2181 and extend out of the first bottom surface 2122 of the first sensor module 21.
[0152] In some examples, the shape of the first through hole 2181 may match the shape of the first sharp portion 2172. Specifically, if the first sharp portion 2172 is a prism (such as Figure 6B shown), the shape of the first through hole 2181 may also be a corresponding prism-shaped hole.
[0153] In some examples, the first distal portion 2111 of the first electrode 211 may extend out of the first bottom surface 2122 of the first sensor module 21 through the first through hole 2181.
[0154] In some examples, the first sharp portion 2172 may penetrate the skin layer of the target at an angle substantially perpendicular to the skin layer of the target. For example, the first sharp portion 2172 of the first guiding needle 217 may penetrate the skin layer of the target vertically in the D2 direction (refer to Figure 6F ).
[0155] In some examples, the first sharp portion 2172 may also penetrate the skin layer of the target at a predetermined oblique angle.
[0156] In the present disclosure, the position of the surface of the first sensor module 21 with the first guiding needle 217 not attached to the skin layer may be defined as the first position, and the position of the surface of the first sensor module 21 attached to the skin layer may be defined as the second position.
[0157] In some examples, the first sensor module 21 with the first guiding needle 217 may move from the first position in the D2 direction towards the skin layer of the target to penetrate the skin layer of the target (refer to Figure 6F ).
[0158] In some examples, after the first guiding needle 217 penetrates the skin layer and the first electrode 211 comes into contact with the tissue fluid, that is, when the first sensor module 21 is in the second position, the first guiding needle 217 may be withdrawn in the D1 direction to the second position to be separated from the first sensor module 21 (refer to Figure 6G ), while retaining the first distal portion 2111 of the first electrode 211 within the skin layer.
[0159] In some examples, a sealing body may be provided on the first top surface 2121 of the first housing 212. In this case, when the first guiding needle 217 leaves the first sensor module 21, by providing the sealing body, damage to the first electrode 211 caused by moisture or other contaminants can be reduced.
[0160] Figure 7A FIG. is a schematic diagram showing the second guiding needle 227 according to an example of the present disclosure located in the second sensor module 22. Figure 7B FIG. is a schematic diagram showing another view direction of the second guiding needle 227 according to an example of the present disclosure located in the second sensor module 22. Figure 7C FIG. is a schematic diagram showing the cooperation between the second guiding needle 227 and the second electrode 221 according to an example of the present disclosure. Figure 7D FIG. is a schematic diagram showing the second guiding needle support 228 according to an example of the present disclosure. Figure 7E FIG. is a schematic diagram showing the second guiding needle 227 piercing the skin layer according to an example of the present disclosure. Figure 7F FIG. is a schematic diagram showing the second guiding needle 227 withdrawing from the second sensor module 22. In Figure 7E and Figure 7F , the shaded part represents the skin layer.
[0161] In some examples, referring to Figure 7A , the subcutaneous continuous electrocardiogram monitoring system 10 may further include a second guiding needle 227 provided on the second housing 222.
[0162] In some examples, the second housing 222 may include a second top surface 2221 and a second bottom surface 2222 (refer to Figure 2A and Figure 2B ). In this case, the second top surface 2221 and the second bottom surface 2222 can form an accommodation space.
[0163] In some examples, openings are respectively provided on the second top surface 2221 and the second bottom surface 2222, and the second sharp part 2272 of the second guiding needle 227 may be configured to extend along the longitudinal axis T2 (refer to Figure 7A ) through the opening on the second top surface 2221 and the opening on the second bottom surface 2222.
[0164] In some examples, the second guiding needle 227 may have a hollow second sharp part 2272, that is, the second sharp part 2272 has an accommodation space, and the second distal part 2211 of the second electrode 221 may be provided in the second sharp part 2272 of the second guiding needle 227.
[0165] In some examples, the second sharp part 2272 may have a groove (refer to Figure 7B) The second distal portion 2211 can be disposed within the groove. In some examples, the groove of the second sharp portion 2272 can be similar in shape to the above Figure 6B or Figure 6C .
[0166] In some examples, the second guiding needle 227 can include a second head 2271 (see Figure 7C ).
[0167] In some examples, see Figure 7D , the second housing 222 can be provided with a second guiding needle support 228. The second guiding needle support 228 can have a second through hole 2281. The second guiding needle 227 can pass through the second through hole 2281 and extend out of the second bottom surface 2222 of the second sensor module 22 (see Figure 7A and Figure 7B ).
[0168] In some examples, the shape of the second through hole 2281 can match the shape of the second sharp portion 2272.
[0169] In some examples, the second distal portion 2211 can extend out of the second bottom surface 2222 of the second sensor module 22 through the second through hole 2281.
[0170] In some examples, the second sharp portion 2272 can pierce the skin layer of the target at an angle substantially perpendicular to the skin layer of the target.
[0171] In some examples, the second sharp portion 2272 can also pierce the skin layer of the target at a predetermined oblique angle.
[0172] In the present disclosure, the position where the second sensor module 22 with the second guiding needle 227 is not attached to the surface of the skin layer can also be defined as the third position, and the position where the second sensor module 22 is attached to the surface of the skin layer can be defined as the fourth position.
[0173] In some examples, the second sensor module 22 with the second guiding needle 227 can move from the third position along the D2 direction towards the skin layer of the target to pierce the skin layer of the target (see Figure 7E ).
[0174] In some examples, after the second guiding needle 227 pierces the skin layer and the second electrode 221 comes into contact with the tissue fluid, that is, when the second sensor module 22 is in the fourth position, the second guiding needle 227 can be withdrawn along the D1 direction to the third position to separate from the second sensor module 22 (see Figure 7F ), while retaining the second distal portion 2211 of the second electrode 221 within the skin layer and in contact with the tissue fluid.
[0175] In some examples, a seal may be provided at the opening of the second top surface 2221 of the second housing 222.
[0176] In some examples, the first guiding needle 217 or the second guiding needle 227 may be automatically or manually implanted into the target skin layer by an actuator (also known as a needle assisting device).
[0177] In some examples, the first guiding needle 217 or the second guiding needle 227 may also be automatically or manually separated from the target skin layer 80, that is, the first guiding needle 217 is withdrawn and separated from the first sensor module 21, and the second guiding needle 227 is withdrawn and separated from the second sensor module 22.
[0178] Figure 8 FIG. is a schematic diagram showing the positioning device 60 involved in the examples of the present disclosure.
[0179] In some examples, referring to Figure 8 , the subcutaneous continuous electrocardiogram monitoring system 10 may further include a positioning device 60, and the positioning device 60 may be used to keep the distance between the first sensor module 21 and the second sensor module 22 on the target skin within a preset range. In this case, the distance between the first sensor module 21 and the second sensor module 22 can be kept within the preset range, so that the distance between the first sensor module 21 and the second sensor module 22 meets the measurement requirements, and thus electrocardiogram signal data at a predetermined position can be obtained.
[0180] In some examples, the distance between the first sensor module 21 and the second sensor module 22 may refer to the shortest distance after connecting the position points where the first electrode 211 and the second electrode 221 are implanted into the skin layer on the skin.
[0181] In some examples, the preset range of the distance between the first sensor module 21 and the second sensor module 22 may be not less than 2 cm. In some examples, the preset range of the distance between the first sensor module 21 and the second sensor module 22 may be not greater than 50 cm.
[0182] In some examples, the positioning device 60 may be two interconnected rings (such as Figure 8 the first ring 61 and the second ring 62 in
[0183] In some examples, the positioning device 60 may be two interconnected rings, and the distance between the centers of the two rings is within a preset range. In this case, the distance between the first sensor module 21 and the second sensor module 22 can be roughly positioned by the two rings, so that the distance between the first sensor module 21 and the second sensor module 22 is within the preset range.
[0184] In some examples, the positioning device 60 may be two interconnected rings. The diameter of the first ring 61 may be slightly larger than the outer dimension of the first sensor module 21 or the second sensor module 22, and the diameter of the second ring 62 may be slightly larger than the outer dimension of the needle aid. In practical applications, taking Figure 8 as an example, before using the positioning device 60, the first sensor module 21 can be first applied to the skin, then the first ring 61 of the positioning device 60 is sleeved on the first sensor module 21, then the needle aid is placed inside the second ring 62, and the other second sensor module 22 is applied to the skin. Thus, the distance between the first sensor module 21 and the second sensor module 22 can be defined.
[0185] Figure 9A is a schematic diagram showing the data processing unit 32 involved in the examples of the present disclosure. Figure 9B is a block diagram showing the composition of the data processing unit 32 involved in the examples of the present disclosure.
[0186] In some examples, referring to Figure 9A , the electronic module 30 may include a data processing unit 32 coupled to the sensor module 20. In this case, the data processing unit 32 can receive the electrocardiogram signal data measured by the sensor module 20 and process the electrocardiogram signal data.
[0187] In some examples, the first proximal portion 2112 of the first electrode 211 may be coupled to the data processing unit 32 through the first electrical contact 21121. In some examples, the second proximal portion 2212 of the second electrode 221 is coupled to the data processing unit 32 through the second electrical contact 22121. In some examples, the first proximal portion 2112 and the second proximal portion 2212 may transmit the target electrocardiogram signal data to the data processing unit 32.
[0188] In some examples, the data processing unit 32 may be disposed inside the housing 31 (refer to Figure 2A ). Thus, the data processing unit 32 can be protected.
[0189] In some examples, referring to Figure 9B , the data processing unit 32 may include a signal acquisition module 321. In some examples, the signal acquisition module 321 may be an analog-to-digital module. In this case, the electrocardiogram signal data measured by the sensor module 20 is an analog signal. To facilitate the processing of the electrocardiogram signal data, by setting the signal acquisition module 321, the analog signal is converted into a digital signal, which is convenient for the data processing unit 32 to process the electrocardiogram signal data.
[0190] In some examples, the data processing unit 32 may include a communication module 322. In this case, the data processing unit 32 can establish a communication connection with an external device and can transmit the electrocardiogram signal data to the external device, such as the terminal 40.
[0191] In some examples, the communication module 322 can communicate with the terminal 40 through a communication link 70.
[0192] In some examples, the data processing unit 32 may include a processor module 323. In some examples, the processor module 323 may include an application specific integrated circuit (ASIC).
[0193] In some examples, the data processing unit 32 may include a storage module 324 for storing data, such as electrocardiogram signal data, program data, status data of errors occurring during the operation of the data processing unit 32, and the like.
[0194] In some examples, the storage module 324 may include any one or more of a read only memory (ROM), a random access memory (RAM), and a non-volatile memory (NVM).
[0195] In some examples, the data processing unit 32 may include a power module 326. In some examples, the power module 326 may be a rechargeable battery or a disposable battery. Thus, the periodic requirements of electrocardiogram monitoring can be met by charging or replacing the battery.
[0196] In some examples, the data processing unit 32 may include a circuit board 325. Thus, electronic devices can be arranged on the circuit board 325.
[0197] Figure 10 It is a schematic diagram showing another embodiment of the subcutaneous continuous electrocardiogram monitoring system 10 involved in the examples of the present disclosure.
[0198] In some other examples, the first electrode 211 can be arranged on the electronic module 30, that is, the first signal line 50a can be omitted, and the first electrode 211 and the electronic module 30 can form a separate device.
[0199] In some other examples, the second electrode 221 can be arranged on the electronic module 30, that is, the second signal line 50b can be omitted, and the second electrode 221 and the electronic module 30 can form a separate device.
[0200] In some other examples, referring to Figure 10 , the first electrode 211 and the second electrode 221 can be arranged on the electronic module 30 at the same time, that is, the first signal line 50a and the second signal line 50b can be omitted, and the first electrode 211 and the second electrode 221 can form a separate device.
[0201] Therefore, in the present disclosure, by implanting the first electrode 211 and the second electrode 221 under the skin of the target to contact the tissue fluid of the target, electrocardiogram signal data can be measured, and a measurement circuit can be formed, so that the electrocardiogram signal of the target can be continuously measured, and the electrocardiogram signal can be transmitted to the electronic module 30 for processing. Furthermore, the electronic module 30 can transmit the obtained electrocardiogram signal to the terminal 40 to indicate the electrocardiogram signal data of the target on the terminal 40. Thus, the electrocardiogram signal data of the target can be conveniently and continuously monitored.
[0202] Although the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it should be understood that the above description does not limit the present disclosure in any form. Those skilled in the art can make deformations and changes to the present disclosure according to needs without departing from the essence and scope of the present disclosure, and these deformations and changes all fall within the scope of the present disclosure.
Claims
1. A subcutaneous continuous electrocardiogram monitoring system is a monitoring system used to measure electrocardiogram signal data of a target, characterized in that it includes a sensor module attached to the skin of the target, an electronic module coupled to the sensor module, and a terminal; the sensor module includes a first sensor module and a second sensor module, the first sensor module includes a first electrode, and the second sensor module includes a second electrode; the first electrode and the second electrode respectively have a distal portion implanted under the skin of the target and a proximal portion coupled to the electronic module; the distal portions of the first electrode and the second electrode are respectively configured to be inserted under the skin of the target to obtain electrocardiogram signal data of the target, and the proximal portions of the first electrode and the second electrode are configured to transmit the electrocardiogram signal data to the electronic module; the terminal establishes a communication connection with the electronic module and receives and indicates the electrocardiogram signal data from the electronic module, wherein the first electrode, the second electrode, and the electronic module form a measurement circuit.
2. The subcutaneous continuous electrocardiogram monitoring system according to claim 1, characterized in that the distal portions of the first electrode and the second electrode respectively extend at a preset angle deviating from the horizontal direction to form the preset angle with the horizontal direction.
3. The subcutaneous continuous electrocardiogram monitoring system according to claim 1, characterized in that the first sensor module includes a first housing, the second sensor module includes a second housing, the first electrode is detachably connected to the first housing, the second electrode is detachably connected to the second housing, and removable adhesive materials are respectively provided on the third bottom surface of the electronic module, the first bottom surface of the first housing, and the second bottom surface of the second housing.
4. The subcutaneous continuous electrocardiogram monitoring system according to claim 3, characterized in that the distal portion of the first electrode includes a first conductive portion implanted under the skin of the target, the proximal portion of the first electrode includes a first electrical contact coupled to the electronic module, the distal portion of the second electrode includes a second conductive portion implanted under the skin of the target, and the proximal portion of the second electrode includes a second electrical contact coupled to the electronic module.
5. The subcutaneous continuous electrocardiogram monitoring system according to claim 4, characterized in that the first conductive portion and the second conductive portion are made of precious metals.
6. The subcutaneous continuous electrocardiogram monitoring system according to claim 3, characterized in that the first sensor module includes a first support body provided on the first housing, and the second sensor module includes a second support body provided on the second housing. The first electrode is detachably connected to the first support body, and the second electrode is detachably connected to the second support body.
7. The subcutaneous continuous electrocardiogram monitoring system according to claim 6, characterized in that The first support body includes a first support and a first pressing portion, the second support body includes a second support and a second pressing portion, the first pressing portion presses the proximal portion of the first electrode against the first support, and the second pressing portion presses the proximal portion of the second electrode against the second support.
8. The subcutaneous continuous electrocardiogram monitoring system according to claim 1, wherein a positioning device is included, and the positioning device is configured to keep the distance between the first sensor module and the second sensor module on the skin of the target within a preset range.
9. The subcutaneous continuous electrocardiogram monitoring system according to claim 1, wherein the first electrode and the second electrode each include a biocompatible material.
10. The subcutaneous continuous electrocardiogram monitoring system according to any one of claims 1 to 9, wherein the first electrode is a positive electrode and the second electrode is a negative electrode.