Disposable waterproof electrocardio acquisition device

Abstract

A disposable waterproof electrocardiogram (ECG) acquisition device includes an outer shell comprising an upper cover and a lower cover. The upper and lower covers are connected to form a fully enclosed internal space, within which a circuit board and a disposable battery are placed. The circuit board has metal conductive pins extending from the lower cover. Flexible electrode patches include a conductive gel layer, a metal conductive layer, an insulating layer, a metal attachment layer, and an adhesive layer. Each ECG sampling position has a signal conductive pad on the metal conductive layer, and the conductive gel layer covers each signal conductive pad. Metal wires located within the insulating layer lead to a main conductive pad on the metal attachment layer. Each main conductive pad is connected to a metal conductive pin and then introduced into the circuit board via another metal conductive pin. Two additional main conductive pads are located on the metal attachment layer, connected together by a loop of wires, and each is introduced into the circuit board via two additional metal conductive pins. This invention improves the ease of use and enhances information and hygiene safety.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a disposable waterproof electrocardiogram (ECG) acquisition device. Background Technology

[0002] Current ECG data acquisition devices commonly used in technology include rechargeable and reusable devices and non-rechargeable, single-use devices. Reusable devices are typically used with disposable electrode pads. Each time a data entry is performed, the disposable electrode pads are attached to the device and then placed on the body for recording. After recording, the device is removed, the data is exported, and the device is then disinfected for future use. This raises information and health safety concerns.

[0003] To overcome the aforementioned problems with reusable devices, disposable ECG acquisition devices were developed. Disposable ECG acquisition devices are typically assembled with electrode pads and cannot be separated; they are discarded after data is exported following use.

[0004] However, the conductive connection between the aforementioned disposable devices and disposable electrode pads is usually a direct metal connection or an electrical connection through some flexible conductive foam. Because the conductors only make contact and are not bonded, the contact interface between the conductors will shift when the device moves, introducing significant noise into the ECG signal. Some disposable devices try to reduce this problem by making the conductive wires of the electrode pads into a fixed interface that inserts into the host's female interface to enhance the stability of the electrical connection. However, this design inevitably leaves an opening in the casing to expose the internal female interface, thus compromising waterproofing. Furthermore, disposable devices typically use disposable batteries and do not have a push-button switch. Therefore, an insulating sheet is added to the positive or negative terminal of the battery to isolate the battery from the circuit and reduce the device's standby current. However, this insulating sheet protrudes through a gap in the casing for easy removal by the user, which also prevents the casing from being waterproof, thus limiting its usability, especially for prolonged use. Utility Model Content

[0005] To overcome the shortcomings of existing technologies, such as unstable electrical connections and health and safety issues with reusable devices, and the lack of waterproofing in disposable devices, this utility model provides a disposable waterproof ECG acquisition device, which improves the convenience of use and information and health and safety.

[0006] The technical solution adopted by this utility model to solve its technical problem is:

[0007] A disposable waterproof electrocardiogram (ECG) acquisition device includes a housing, a circuit board, a disposable battery, and flexible electrode patches. The housing includes an upper cover and a lower cover; the upper and lower covers are connected to form a fully enclosed internal space, within which the circuit board and the disposable battery are placed. The circuit board has metal conductive pins extending out of the lower cover. The flexible electrode patches include a conductive gel layer, a metal conductive layer, an insulating layer, a metal attachment layer, and an adhesive layer. The metal conductive layer has a signal conductive pad at each ECG sampling position, and the conductive gel layer covers each signal conductive pad. Metal traces located within the insulating layer lead to a host conductive pad on the metal attachment layer. Each host conductive pad is connected to a metal conductive pin and then introduced into the circuit board through the metal conductive pin. Two additional host conductive pads are located at the metal attachment layer, connected together by looping leads, and introduced into the circuit board by two additional metal conductive pins.

[0008] Furthermore, the circuit board is also equipped with a battery compartment, which enables ECG signal acquisition, storage, real-time / post-test data upload, and patch activation detection; the disposable battery is directly installed in the battery compartment.

[0009] This utility model's disposable waterproof ECG acquisition device has no physical buttons. When not in use, the device is in a low-power standby state. When in use, simply peel off the release film from the surface of the flexible electrode patch with the release film to activate the device without any additional operation.

[0010] Furthermore, the outer shell is formed by a one-time fixed connection of an upper cover and a lower cover, and this fixed connection is an ultrasonic welding connection or a structural adhesive bonding, ensuring that water cannot enter the outer shell from the connection gap between the upper cover and the lower cover, which is a waterproof connection; the lower cover has an opening at the position of the metal conductive needle so that the metal conductive needle can extend out of the lower cover; the rest of the lower cover, except for the opening, is bonded to the corresponding position of the flexible electrode sheet with waterproof adhesive, and the adhesive material is waterproof structural adhesive. This bonding ensures that water cannot enter the opening position of the lower cover from the bottom of the lower cover, which is also a waterproof connection.

[0011] The metal conductive pin is bonded to the main unit's conductive pad with the metal adhesion layer using conductive silicone, and this bonding is a one-time connection.

[0012] The adhesive layer has a surface release paper and a bottom release film. The layers of the flexible electrode patch are arranged from the human skin side as follows: bottom release film, conductive gel layer, insulating layer, metal conductive layer, metal adhesion layer and surface release paper.

[0013] The substrate of the adhesive layer is made of PU material with single-sided adhesive coating, and the substrate has a surface release paper for protection on the side away from the human body; the adhesive material is pressure-sensitive adhesive or silicone; the adhesive side of the human body is protected by a bottom release film; the surface release paper has a hole at the lower cover position to expose the main conductive pad located on the metal attachment layer to the metal conductive pin; the surface release paper is located between the outer shell and the metal attachment layer.

[0014] The conductive metal layer is attached to the metal adhesive layer, and the conductive metal layer is formed by printing or etching. The material of the conductive metal layer is silver or copper. The loop connection on the conductive metal layer protrudes outside the lower cover and is pasted on the surface release paper.

[0015] The insulating layer covers the upper and lower surfaces of all metal attachment layers except for the signal conductive disk and the host conductive disk;

[0016] Preferably, the material of the metal adhesion layer is PET or PI;

[0017] The circuit board includes an electrocardiogram (ECG) signal acquisition module, an ECG signal storage module, an ECG signal processing module, and a power supply module. The ECG signal acquisition module acquires ECG signals from each lead formed by each electrode point and transmits them to the ECG signal processing module. The ECG signal storage module stores the ECG signals in a local memory. The ECG signal processing module performs various processing on the ECG signals, including but not limited to filtering and analog-to-digital conversion.

[0018] The ECG signal acquisition module, ECG signal storage module, and ECG signal processing module are all controlled by a low-power Bluetooth processor;

[0019] The electrocardiogram signal storage module uses a large-capacity memory for storage;

[0020] The ECG signal processing module receives ECG data collected by the ECG signal acquisition module, processes the data, and stores it in the ECG signal storage module. It can also connect to a mobile terminal via Bluetooth Low Energy to transmit ECG data in real time. The ECG signal processing module can upload all stored data to the mobile terminal after the device is used.

[0021] The power module is powered by a disposable battery; the disposable battery can be a lithium manganese battery or a zinc-air battery.

[0022] The circuit board also includes a patch enable detection module, which is used to detect whether the flexible electrode patch has been enabled. The patch enable detection module has an analog switch and a control circuit. The analog switch controls the power supply. The control circuit detects whether the external loopback connection connected to the patch enable detection module is disconnected. If disconnected, the analog switch is turned on to power on the device. If not disconnected, the device is kept in a low-power state. The power consumption of the control circuit is less than 1uA.

[0023] The beneficial effects of this utility model are mainly reflected in:

[0024] 1. The main unit casing and flexible electrode patches are fixed together, eliminating the need for separation during and after use. They are disposable after use, improving the convenience, information security, and hygiene safety of the equipment. Furthermore, the connection between the lower cover of the casing and the flexible electrode patches is achieved using structural adhesive, while the upper and lower covers are connected using structural adhesive or ultrasonic welding, ensuring an IPX7 waterproof rating for the entire machine. Additionally, the electrical connection between the circuit board inside the casing and the conductive pads of the flexible electrode patches uses conductive silicone adhesive, improving the electrical stability of the connection and significantly reducing electrical noise caused by unstable connections. Moreover, powering on the equipment only requires removing the release paper / film from both sides of the flexible electrode patches; no additional power-on operations are required, such as removing insulating sheets or clicking buttons.

[0025] 2. The flexible electrode patch consists of an adhesive layer and an electrode circuit layer. The layer structure is simple. When using it, you only need to peel off the release paper / film. The operation is simple and convenient.

[0026] 3. The battery uses disposable batteries and is pre-installed in the battery compartment on the circuit board, which facilitates processing and assembly. Furthermore, being enclosed in a sealed casing and flexible electrode patch assembly, it is not exposed to the external environment, significantly improving the battery's shelf life and thus extending the equipment's shelf life. Attached Figure Description

[0027] Figure 1 This is a structural block diagram of an embodiment of the present utility model;

[0028] Figure 2 This is a block diagram of the circuit board of this utility model;

[0029] Figure 3 This is a simplified diagram of the patch enable detection circuit in an embodiment of this utility model.

[0030] Explanation of reference numerals in the attached diagram: 10-Outer shell, 11-Top cover, 12-Lower cover, 20-Circuit board, 21-Battery compartment, 22-Metal conductive pin, 23-ECG signal acquisition module, 24-ECG signal storage module, 25-ECG signal processing module, 26-Patent activation detection module, 261-Analog switch, 262-Detection control circuit, 27-Power module, 30-Disposable battery, 40-Flexible electrode patch, 41-Conductive gel layer, 42-Metal conductive layer, 43-Insulating layer, 44-Metal adhesion layer, 45-Patent layer, 451-Patent layer release paper, 452-Patent layer release film, 46-Signal conductive disk, 47-Main unit conductive disk, 48-Loop connection. Detailed Implementation

[0031] The present invention will now be further described with reference to the accompanying drawings.

[0032] Reference Figures 1-3 A disposable waterproof electrocardiogram (ECG) acquisition device includes a main unit housing 10 and a flexible electrode patch 40. The layers of the flexible electrode patch 40, starting from the human skin side, are arranged in the following order: a conductive gel layer 41, an insulating layer 43, a metal conductive layer 42, a metal adhesion layer 44, and an adhesive layer 45. The metal conductive layer 42 has three exposed signal conductive pads 46 on the side of the flexible electrode patch 40 closest to the human body, and the metal adhesion layer 44 has five exposed main unit conductive pads 47 on the side furthest from the human body. The housing 10 is composed of an upper cover 11 and a lower cover 12, which are fixed together by ultrasonic welding. The lower cover 12 and the metal adhesion layer 44 of the flexible electrode patch 40 are fixedly bonded together with waterproof structural adhesive to form a complete ECG acquisition device.

[0033] The upper cover 11 and the lower cover 12 can also be joined by structural adhesive.

[0034] The interior of the outer shell 10 is completely isolated from the external environment, forming a fully enclosed internal space. The formation of this enclosed space depends on the following: the upper cover 11 is seamless; the connection seam between the upper cover 11 and the lower cover 12 is completely sealed by ultrasonic welding; the lower cover 12 and the metal attachment layer 44 of the flexible electrode patch are fully bonded; and the holes on the lower cover 12 are placed in the internal space formed between the other parts of the lower cover 12 (excluding the holes) and the metal attachment layer.

[0035] The circuit board 20 and the disposable battery 30 thereon are located within the aforementioned completely enclosed space. Because it is in a completely enclosed space, it is not affected by the high salt and high humidity environment of the outside world, which can improve the shelf life of the circuit board 20 and the disposable battery 30.

[0036] like Figure 1As shown, conductive gel 41 covers the signal conductive pads 46, serving as the contact interface between human skin and the metal electrodes. The three signal conductive pads 46 of the metal conductive layer 42 and the five host conductive pads 47 of the metal attachment layer 44 are electrically connected by wires. These wires and conductive pads are formed by printing metal paste onto both sides of the metal attachment layer 44. The signal conductive pads 46 are located on the side of the metal attachment layer 44 closest to the human body, their specific position determined by the ECG lead position of the predicted quantity. The host conductive pads 47 are located on the side of the metal attachment layer 44 furthest from the human body, near the center, directly below the outer casing 10. All wire locations on the metal conductive layer are covered with an insulating layer to protect the circuitry. The side of the metal attachment layer 44 furthest from the human body is covered with a release paper 451 of the adhesive layer 45. The release paper 451 has an opening directly below the outer casing 10 to allow the lower cover 12 to be adhered to the metal attachment layer.

[0037] As an alternative, the metal conductive layer 42 can be formed by etching, or by preforming the metal and then attaching it to the metal attachment layer 44.

[0038] like Figure 1 As shown, the metal conductive pin 22 is pre-soldered to the circuit board 10, passing through the pre-drilled hole in the lower cover 12 and bonded to the main unit conductive pad 47 with silicone conductive adhesive. This method allows the section from the signal conductive pad 46 to the ECG acquisition module 23 in the ECG transmission path to form a complete, inseparable signal transmission path with consistent impedance, minimizing changes in contact impedance and thus minimizing contact noise.

[0039] Alternatively, conductive adhesives that are inelastic after curing can also be used.

[0040] like Figure 1 As shown, the adhesive layer 45 has a bottom release film 452 on the side closest to the human body and a top release paper 451 on the side furthest from the human body. The bottom release film 452 protects the adhesive coating of the adhesive layer and is removed before being applied to the human skin to expose the adhesive coating, which is used to adhere the adhesive layer to the human skin, thereby fixing the device to the human body and allowing the aforementioned conductive gel layer 41 to contact the human skin. The top release paper 451 shapes the flexible adhesive layer 45, preventing the adhesive layer 45 from becoming misshapen and difficult to apply to the human body after the bottom release film 452 is removed.

[0041] like Figure 1As shown, in addition to signal acquisition, the circuit board 10 also has two additional metal conductive pins 22. The connection between the two host conductive disks 47 connected to the conductive pins 22 and the metal conductive layer is a loop connection 48. That is, the two host conductive disks 47 are connected together by a wire. The part of the metal attachment layer to which the wire is attached forms a protrusion that extends from the release paper 451 on the side of the adhesive layer 45 away from the human body at the opening under the outer shell and is pasted on the release paper 451 on the side of the adhesive layer 45 away from the human body. This protrusion can be removed together after the release paper 451 is removed when using the device, thereby cutting off the electrical connection between the two host conductive disks 47.

[0042] like Figure 2 As shown, the circuit board 20 consists of functional modules such as an ECG signal acquisition module 23, an ECG signal storage module 24, an ECG signal processing module 25, a patch activation detection module 26, and a power supply module 27. The input path of the human ECG signal is: human body, conductive gel 41, signal conductive disk 46, host conductive disk 47, metal conductive needle 22, and ECG signal acquisition module 23. The ECG signal is acquired by the ECG acquisition module 23 and converted into a digital signal through analog-to-digital conversion before being transmitted to the ECG signal processing module 25. After filtering and other processing, the ECG signal processing module stores the signal in the memory of the ECG signal storage module 24. In this embodiment, the main controller of the circuit board integrates a Bluetooth BLE protocol processor.

[0043] As an alternative implementation, the Bluetooth BLE processor in this example can be replaced with a processor that employs other wireless communication functions.

[0044] like Figure 3 As shown, the patch enable detection module 26 includes an analog switch 261 and a detection control circuit 262. The analog switch 261 is located between the disposable battery 30 and the circuit board 20. Whether the switch is open or closed determines whether the disposable battery 30 is connected to the circuit board 20 to supply power to the circuit board 20. A PMOS transistor can be used. The detection control circuit 262 is connected to the aforementioned two additional metal conductive pins 22. It determines whether the connection between these two metal conductive pins 22 is broken. If it is broken, it outputs a 0 level; otherwise, it outputs a high level. A resistor voltage divider can be used. When the external loopback connection 48 is not broken, the battery forms a voltage much higher than the turn-on voltage at the gate of the PMOS transistor Q1 through the resistor voltage divider, thereby turning off Q1 and disconnecting the battery voltage from the subsequent load. Since the resistor value used for the resistor voltage divider is very large, the standby power consumption of this control circuit is very small, less than 1uA, reaching the 100nA level. For the commonly used disposable batteries in this control circuit, such as the CR2025 lithium manganese battery, the energy consumed in one year on the shelf is equivalent to only 3mAh of capacity, accounting for 2% of the total capacity, which basically does not affect the service life of the equipment.

[0045] As an alternative implementation, the analog switch and control circuit in this embodiment can be implemented using low-power integrated circuits.

[0046] The embodiments described in this specification are merely examples of implementations of the inventive concept and are for illustrative purposes only. The scope of protection of this utility model should not be considered limited to the specific forms described in these embodiments; rather, it extends to equivalent technical means that can be conceived by those skilled in the art based on the inventive concept.

Claims

1. A disposable waterproof electrocardiogram (ECG) acquisition device, characterized in that, The device includes a housing (10), a circuit board (20), a disposable battery (30), and a flexible electrode patch (40). The housing (10) includes an upper cover (11) and a lower cover (12). The upper cover (11) and the lower cover (12) are connected to form a fully enclosed internal space. The circuit board (20) and the disposable battery (30) are placed in the fully enclosed internal space. The circuit board (20) is provided with metal conductive pins (22) extending out of the lower cover (12). The flexible electrode patch (40) includes a conductive gel layer (41), a metal conductive layer (42), an insulating layer (43), a metal adhesion layer (44), and an adhesive layer (45). The conductive layer (42) has a signal conductive disk (46) at each ECG sampling position, and the conductive gel layer (41) covers each signal conductive disk (46); it is led to a host conductive disk (47) on the metal attachment layer (44) through a metal trace located in the insulating layer (43), and a host conductive disk (47) is connected to a metal conductive needle (22) and introduced into the circuit board (20) through a metal conductive needle (22); there are two additional host conductive disks (47) at the position of the metal attachment layer (44), which are connected together by a lead loop (48) and introduced into the circuit board (20) by two other metal conductive needles (22).

2. The disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 1, characterized in that, The circuit board (20) is also provided with a battery compartment (21). The circuit board (20) realizes the functions of ECG signal acquisition, storage, real-time / post-test data upload and patch activation detection. The disposable battery (30) is directly installed in the battery compartment (21).

3. A disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 1 or 2, characterized in that, The outer shell (10) is formed by a one-time fixed connection of an upper cover (11) and a lower cover (12), and the fixed connection is an ultrasonic welding connection or a structural adhesive bonding, which ensures that water cannot enter the outer shell (10) from the connection gap between the upper cover (11) and the lower cover (12), which is a waterproof connection; the lower cover (12) has an opening at the position of the metal conductive needle (22) so that the metal conductive needle (22) can extend out of the lower cover (12); the rest of the lower cover (12) except for the opening is bonded to the corresponding position of the flexible electrode patch with waterproof adhesive. The adhesive material is waterproof structural adhesive. This bonding ensures that water cannot enter the opening position of the lower cover (12) from the bottom of the lower cover (12), which is also a waterproof connection.

4. A disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 1 or 2, characterized in that, The metal conductive needle (22) and the host conductive disk (47) of the metal attachment layer (44) are bonded together by conductive silicone, and the bonding is a one-time connection.

5. A disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 1 or 2, characterized in that, The patch layer (45) has a surface release paper (451) and a bottom release film (452). The layers of the flexible electrode patch (40) are arranged from the human skin side as follows: bottom release film (452), conductive gel layer (41), insulating layer (43), metal conductive layer (42), metal adhesion layer (44) and surface release paper (451).

6. The disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 5, characterized in that, The substrate of the adhesive layer (45) is made of PU material with single-sided adhesive coating. The adhesive coating is on the side close to the human body, and the substrate has a surface release paper (451) on the side away from the human body to protect the substrate. The adhesive coating material is pressure-sensitive adhesive or silicone. The adhesive coating side is protected by a bottom release film (452). The surface release paper (451) has an opening at the position of the lower cover (12) to expose the host conductive pad (47) located on the metal attachment layer (44) to the metal conductive pin (22). The surface release paper (451) is located between the outer shell (10) and the metal attachment layer (44).

7. A disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 5, characterized in that, The conductive metal layer (42) is attached to the metal attachment layer (44), and the conductive metal layer (42) is formed by printing or etching. The material of the conductive metal layer (42) is silver or copper. The loop connection (48) on the conductive metal layer (42) protrudes from the lower cover (12) and is pasted on the surface release paper (451).

8. A disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 1 or 2, characterized in that, The insulating layer (43) covers the upper and lower surfaces of all metal attachment layers (44) except for the signal conductive disk (46) and the host conductive disk (47).

9. A disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 1 or 2, characterized in that, The circuit board (20) includes an electrocardiogram (ECG) signal acquisition module (23), an ECG signal storage module (24), an ECG signal processing module (25), and a power supply module (27). The ECG signal acquisition module acquires ECG signals from each lead formed by each electrode point and transmits them to the ECG signal processing module. The ECG signal storage module stores the ECG signals in a local memory. The ECG signal processing module performs various processing on the ECG signals, including but not limited to filtering and analog-to-digital conversion.

10. A disposable waterproof electrocardiogram (ECG) acquisition device as described in claim 9, characterized in that, The circuit board (20) also includes a surface mount enable detection module (26), which has an analog switch (261) and a control circuit (262). The analog switch (261) controls the power supply. The control circuit (262) detects whether the external loopback connection (48) connected to the surface mount enable detection module is disconnected. If it is disconnected, the analog switch (261) is turned on to power on the device. If it is not disconnected, the device is kept in a low power consumption state.

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