TWI701017B - Flexible ecg detection device - Google Patents

Abstract

A flexible ECG detection device is disclosed and includes a sensor module. The sensor module includes multiple signal detection units. Each of the signal detection units has a patch. And the sensor module includes multiple shield layers and multiple protective layers. The shield layers are correspondingly cover the multiple signal detection units. Each of the shield layers has multiple holes. Each of the holes accommodates the patch so as to expose the patch on the shield layers. The protective layers are correspondingly cover the shield layers. Each of the protective layers has multiple perforations. Each of perforations is corresponding to each of position of the holes so as to expose the patch. The sensor module also electrically connects a signal collection module. The signal collection module is used to receive the signal from the signal detection units and transfer the signal.

Description

Flexible ECG detection device

The present invention relates to an ECG detection device, in particular to a flexible ECG detection device with malleable equipment.

Since the potential changes generated by the heart itself will be reflected on the body surface through the conductive tissues and body fluids around the heart, and electrocardiogram (ECG) devices use this kind of characterization to record changes in the heart's tiny electrical pulses through microelectrode technology , And the generated potential difference between the inside and outside of myocardial cells, and then the graph drawn by the electrical activity signal is amplified by the instrument to further understand whether the heart is functioning normally.

The electrocardiogram device uses a standard 12-lead system to place electrodes on different parts of the human body, and connect them to the positive and negative electrodes of the electrocardiograph galvanometer through lead wires, and further display the measured signals on the system or monitors. Interpretation of the signal; the traditional and common 12-lead applications, the common conventional structure is divided into two types: suction ball and fixture, and patch and fixture. Through this structure, it is directly attached to the human body and the signal has been measured. .

However, the traditional 12-lead conventional structure, including suction ball plus fixture and patch plus fixture, is familiar and commonly used equipment by medical staff, but whether it is suction ball plus fixture or patch plus fixture, it must be done manually One by one, it takes a long time to deploy on the human body, which will affect the effectiveness of emergency care; follow-up on the improvement of the ECG device, another disposable patch has been developed and marketed, but this disposable patch The area of the product may be large or small, which will affect the quality of the signal measurement due to the size of the human body. There are also related products that use rigid patches, but such products are prone to large extension areas. The risk of signal line breakage has become a major defect of the electrocardiogram device.

In view of the above-mentioned deficiencies, the main purpose of the present invention is to provide a flexible ECG detection device, so as to provide an ECG device designed to be light, thin and malleable, and can be equipped with 12 leads required for the ECG at one time. ) Patch to allow users to quickly install and fit most humans.

To achieve the above objective, the present invention mainly provides a flexible ECG detection device, which includes: a sensor module, the sensor module further includes a plurality of signal detection units; and a plurality of protection layers, the protection layers For the corresponding combination, the protective layers are made of materials with irreversible elasticity. A plurality of perforations are provided on each protective layer. The perforations correspond to the aforementioned plural signal detection units, so that the signals are detected. The unit is exposed.

In order to make the above and other objects, features and advantages of the present invention more comprehensible, preferred embodiments and accompanying drawings are described in detail as follows.

The following describes the technical means adopted by the present invention to achieve the predetermined purpose in conjunction with the drawings and preferred embodiments of the present invention.

Please refer to Figures A and B, which are schematic diagrams of the operation of the present invention. As shown in Figures A and B, the flexible ECG detection device of the present invention is used to attach to a subject 100 to detect the ECG activity. As shown in the top and bottom views of the three-dimensional structure in the second and third figures, the flexible ECG detection device of the present invention mainly includes a sensor module 1 and a signal collection module 2. The sensor module 1 further includes a plurality of signal detection units 11. As shown in the exploded view of the three-dimensional structure of the sensor module in FIG. 4, in this embodiment, the plurality of signal detection units 11 have 10 groups, which conform to the standard electrocardiogram. The standard twelve leads (leads) that need to be measured are required. Each signal detection unit 11 includes a wire 111. The wire 111 can extend with a large area when stretched, and can be adjusted to adjust the length. There is a risk of breaking, the wire 111 can be compressed in either spiral winding or folding. In this embodiment, the wire 111 is a spiral enameled wire, and one end of each wire is connected to a patch 112, the The other ends of the wires 111 of the signal detection units 11 are electrically integrated in a wire integration port 12, and the wire integration port 12 is used to jointly transmit the ECG signals measured by the signal detection units 11. In one embodiment, the wire 111 is made of copper alloy; in another embodiment, the wire 111 is made of nickel alloy.

In the preferred embodiment, the sensor module 1 can be a thin, thin and flexible sheet with a symmetrical appearance, which is convenient for storage and unfolding, so as to be attached to the upper body of the subject 100. The signal collection module 2 can be a mobile ECG Machine (ECG monitor), as shown in Figures A and B, the sensing module 1 includes a central part CP, a first branch BR1, a second branch BR2, a third branch BR3, a fourth branch BR4, and a fifth branch BR5 , The first branch BR1 extends from the central part CP toward the first direction D1, the second branch BR2 extends from the central part CP toward the second direction D2, the third branch BR3 extends from the central part CP to the third direction D3, and the fourth branch BR4 Extending from the central part CP to the third direction D3, the fifth branch BR5 extends from one side of the central part CP. The plane of the central part CP of the self-sensing module 1 penetrates to define a vertical axis VA whose vertical axis VA is parallel to the third direction D3. In addition, the projection points of the first direction D1 and the second direction D2 on the vertical axis VA Compared to the third direction D3.

Still referring to the first A and B, the first branch BR1 and the second branch BR2 respectively extend from the upper left part and the upper right part of the central part CP, thus forming a V-shaped structure that is symmetrical with respect to the vertical axis VA. With this V-shaped structure, when the central part CP of the sensing module 1 is placed on the chest of the subject 100, the first branch BR1 and the second branch BR2 can be easily placed on the upper limbs (for example, arms of the subject 100). Or the armpit area) or stretched to the upper extremity (for example, the arm or armpit area).

The third branch BR3 and the fourth branch BR4 of the sensor module 1 respectively extend from the lower left part and the lower right part of the central part CP of the sensor module 1. In one embodiment, when the sensing module 1 is in an unstretched state, the lengths of the third branch BR3 and the fourth branch BR4 of the sensing module 1 are greater than the lengths of the first branch BR1 and the second branch BR2. When the central part CP of the sensing module 1 is attached to the chest of the subject 100, the third branch BR3 and the fourth branch BR4 are appropriately placed in the groin area of the subject 100 or stretched to the lower limbs (such as legs). ). In addition, the central part CP of the sensing module 1 may have a pair of curves symmetrically curved inwardly with respect to the vertical axis VA. When the central part CP is attached to the chest of the subject, it can avoid covering the breast of the subject.

In one embodiment, the fifth branch BR5 of the sensing module 1 extends from the lower side of the central part CP. In detail, the fifth branch BR5 extends in parallel between the third branch BR3 and the fourth branch BR4, each The wire 111 of the signal detection unit 11 is arranged in series on the fifth branch BR5 to form a wire integration port 12 which is electrically connected to the signal detection unit 11 and the signal collection module 2. In addition, in the preferred embodiment of the present invention, the sensor module 1 is sufficient to accommodate all the signal detection units 11, and the appearance and shape of the sensor module 1 may vary according to actual needs.

Please refer to Figures A and B. When the flexible ECG detection device is attached to the subject 100, basically, the signal detection unit 1 roughly matches the standard 12-lead ECG detection position. The first branch BR1, the second branch BR2, the third branch BR3, and the fourth branch BR4 of the sensing module 1 are respectively used for accommodating at least one signal detection unit 11 so that the electrodes of the signal detection unit 11 can correspond to the first Branch BR1, second branch BR2, third branch BR3, and fourth branch BR4. When the central part CP of the sensing module 1 is attached to the chest of the subject 100, the signal detection units 11 of the first branch BR1 to the fourth branch BR4 match the subject 100's limbs.

In order to meet different body structures, the position of the signal detection unit 11 is adjustable. The position of the signal detection unit 11 is adjusted by stretching the sensor module 1. For example, the third branch BR3 and the fourth branch BR4 are extended to ensure that the signal detection unit 11 on the third branch BR3 and the fourth branch BR4 reaches the exact position on the leg of the subject 100.

In a preferred embodiment, as shown in Figures A and B, the signal detection unit 11 has 10 electrodes. In detail, the first branch BR1 has an electrode, which is labeled RA and is placed on the right upper arm (placed on the outer right shoulder, preferably on the bone, not on the muscle), and the second branch BR2 has An electrode, labeled LA, is placed on the left upper arm (placed on the outer left shoulder, preferably on the bone, not the muscle). The central part CP has six electrodes, which are marked as V1, V2, V3, V4, V5, and V6 according to the positions of the electrodes on the chest of the subject 100. The third branch BR3 has an electrode, which is labeled RL and is arranged on the right leg. The fourth branch BR4 has an electrode, which is labeled LL and is arranged on the left leg.

Please refer to the second and third figures, which show the top and bottom perspective views of the flexible ECG detection device. As shown in the second and third figures, at one end of the signal collection interface 22 is a coupling port 221 which is suitable for connecting with the second lead 212 of the wire element 21. In this embodiment, the coupling port 221 is a female connector, and the second guiding connector 212 is a male connector. It should be understood that the effect of reversing the positions of the male connector and the female connector is equivalent to the foregoing embodiment. In addition, at one end of the fifth branch BR5 of the sensing module 1 is a wire integrated port 12, which is used to connect with the first lead 211 of the wire element 21, and is used for centralized transmission of the signals detected by the signal detection unit 11 Telegraph.

Continue to refer to the fourth figure. The sensing module 1 further includes a plurality of shielding layers 13 (Shield mesh), the shielding layer 13 is used to cover the signal detection unit 11, as shown in the partial enlarged view of the fifth figure, thereby shielding the external electromagnetic interference . The shielding layer 13 is made of the same material and has the same shape. The material made of it has good irreversible elasticity to adapt to various bending actions, such as a flat surface or a mesh structure made of a bendable alloy, resulting in the shielding layer 13 Adjust the length during extension without risk of breakage. Moreover, in the stretched state, the shielding layer 13 can maintain the function of anti-interference, and each shielding layer 13 has a plurality of holes 131, and the holes 131 are used to accommodate the patches 112 of the signal detection units 11, resulting in The patches 112 are exposed on the shielding layers 13, and the positions of the holes 131 of the shielding layers 13 are designed to correspond to the standard measurement positions of the electrocardiogram on the human body, so that the patches 112 can directly correspond to the measurement positions . In one embodiment, the shielding layer 13 is made of aluminum alloy to form a net-like plane layer, and the wire 111 can be wound in the net-like plane layer; in another embodiment, the shielding layer 13 can be made of a titanium alloy to form a net-like plane layer, The wire 111 can be wound in the mesh plane layer.

Continue to refer to the fourth figure. The sensing module 1 further includes a plurality of protective layers 14 for correspondingly combining and covering the aforementioned shielding layers 13 therein, and the protective layers 14 are made of elastic and extensible materials. The composition, such as silicone, causes the combined sensing module 1 to be applied to the human body, and it can be applied to human bodies of different postures through its slight curvature. In more detail, when an external force stretches the shielding layer 13 and the protective layer 14, the external force exceeds the elastic limit of the shielding layer 13 and the protective layer 14, causing plastic deformation. As a result, it is widely and firmly applied to On the human body of different postures; each protective layer 14 is provided with a plurality of perforations 141, the positions of the perforations 141 correspond to the positions of the aforementioned holes 131, so that the patches 112 are exposed and can directly correspond to the measurement positions In addition, a protective cover 142 is provided on each perforation 141 of the top protective layer 14. The protective covers 142 are used to protect the patches 112. In this embodiment, the protective cover 142 is integrated with the protective layer 14 constitute. In one embodiment, the shielding layer 13, the protective layer 14 and the wires 111 are formed by thermal compression injection molding to integrate the sensor module 1 into a thin, flexible sheet. According to this, the process time and manufacturing cost are reduced, and the medical disposable type Standard ECG 12-lead patch.

Continue to refer to the second figure. The signal collection module 2 includes a wire element 21 and a signal collection interface 22, wherein the wire element 21 is electrically connected to the wire integration port 12 and the signal collection interface 22, respectively, and is used to transmit the signals The signal measured by the detection unit 11 is transmitted to the signal collection interface 22. One end of the wire element 21 has a first lead connector 211, and the first lead connector 211 is used to lead to the lead integration Port 12, the other end of the wire element 21 has a second lead connector 212, which is electrically connected to the signal collection interface 22; and the signal collection interface 22 is an ECG signal monitor in this embodiment. A coupling port 221 is provided on one end of the signal collection interface 22, and the coupling port 221 is connected to the second conductive connector 212 and forms electrical conduction. In this embodiment, the coupling port 221 is a female connector. The second guide connector 212 is a male connector; in an alternative embodiment, the coupling port 221 is a male connector, and the second guide connector 212 is a female connector. It should be understood that the effect of reversing the positions of the male and female connectors is equivalent to The best embodiment described above. After the signal collection interface 22 receives the signals measured by the signal detection units 11, it transmits the signals to the outside, such as through a wired electrical connection to the monitor, or through wireless signals, such as WiFi or The Bluetooth (BT) signal is transmitted to a portable device (such as a tablet or mobile phone) to facilitate subsequent signal study.

In addition, as shown in the partial three-dimensional structure exploded view of FIG. 6, the patch 112 further includes a wire plastic sheet 1121, the wire plastic sheet 1121 is circular, and the wire plastic sheet 1121 is connected to one end of the wire 111 The bottom of the metal base 1111 is connected, and the bottom area of the wire plastic sheet 1121 is larger than the bottom area of the metal base 1111, and a film 1122 is connected to the bottom surface of the wire plastic sheet 1121, as shown in the structure combination diagram in Figure 7, Cover the metal base 1111 with an upper cover 1123 to cover the metal base 1111; in addition, the bottom surface of the wire plastic sheet 1121 is exposed on the other side of the film 1122, as shown in the top view of the combined structure in Figure 8 As shown, a gel layer 1124 is coated on the other side of the film 1122 and on the periphery of the bottom surface of the wire plastic sheet 1121, so that the wire plastic sheet 1121 can receive ECG signals after contacting the body through the gel layer 1124.

However, the above-mentioned implementations are preferred implementation examples, and should not be used to limit the scope of implementation of the present invention, any equivalent changes or modifications made according to the scope of the patent application of the present invention and the contents of the specification shall all belong to the following The scope of patent coverage.

A signal detecting unit sensing module 111 of the metal stem 11 lead wires 112 SMD plastic film 1111 1121 112 214 perforated film cover 1123 1124 gel layer conductor integrated port holes 12 shield layer 13 protective layer 141 protective cover 131 signal collection module 142 2 a first guide wire element 21 of the second connector 211 guide connector signal collection interface 212 is coupled to port 22 221 D1 D2 direction by a first direction, a third test 100 by a second central portion CP of the first branch BR1 direction D3 of the second branch BR2 Three branches BR3 Fourth branch BR4 Fifth branch BR5 Electrodes RA, LA, RL, LL, V1, V2, V3, V4, V5, V6 Vertical axis VA

The first A and the first B are schematic diagrams of the operation of the flexible ECG detection device of the present invention. The second figure is a top view of the three-dimensional structure of the flexible ECG detection device of the present invention. The third figure is a bottom view of the three-dimensional structure of the flexible ECG detection device of the present invention. The fourth figure is an exploded view of the three-dimensional structure of the induction module of the present invention. The fifth figure is a partially enlarged assembly diagram of the sensing module of the present invention. The sixth figure is an exploded view of part of the three-dimensional structure of the present invention. The seventh figure is a partial structure combination diagram of the present invention. Figure 8 is a top view of the combined structure of the present invention.

A signal detecting unit sensing module 11 module 21 to collect a first signal connector 211 of the second guide 212 guide connector 22 by the signal collection interface 100 in a first direction central portion of the test subject CP D1 direction, the second direction D2 third wire element 2 D3 First branch BR1 Second branch BR2 Third branch BR3 Fourth branch BR4 Fifth branch BR5 Electrodes RA, LA, RL, LL, V1, V2, V3, V4, V5, V6 Vertical axis VA

Claims (13)

A flexible ECG detection device includes: a sensor module, the sensor module further includes a plurality of signal detection units; and a plurality of protective layers, the protective layers are used for corresponding combination, and are arranged on each protective layer There are a plurality of perforations, and the perforations correspond exactly to the aforementioned plural signal detection units, so that the signal detection units are exposed; each of the signal detection units further includes a wire, and the plurality of shielding layers of the sensor module are arranged on the In the protective layers, the shielding layers are used to cover the signal detection units correspondingly, and there are a plurality of holes on each shielding layer, and the positions of the holes correspond to the positions of the aforementioned holes, so that the signals The detection unit is exposed on the shielding layers and the protective layers. For the flexible ECG detection device described in item 1 of the scope of patent application, the material of the protective layers is silicone. For the flexible ECG detection device described in item 1 of the scope of the patent application, the shielding layers are made of materials with irreversible elasticity. For the flexible ECG detection device described in item 1 of the scope of patent application, each of the signal detection units has a patch, and the patch further includes: a wire plastic sheet, and the wire plastic sheet is connected to the One end of the wire is connected to the bottom of a metal seat; a film is connected to the bottom surface of the wire plastic sheet, which is exposed on the other side of the film; a gel layer is coated on the other side of the film And on the periphery of the bottom surface of the wire plastic sheet, so that the wire plastic sheet can receive the ECG signal after contacting the body through the gel layer; and an upper cover is arranged on the metal seat and covers the metal seat among them. For example, the flexible ECG detection device described in item 1 of the scope of patent application further includes a signal collection module which is electrically connected to the sensor module, wherein the sensor module further includes: a central part, A first branch, the first branch extending from the central portion toward a first direction; a second branch, the second branch extending from the central portion toward a second direction to form; a third branch, the A third branch is formed by extending from the central part toward a third direction; a fourth branch is formed by extending from the central part toward a third direction; and a fifth branch is formed by extending from the central part One side of the central part is extended and formed. For the flexible ECG detection device described in item 5 of the scope of patent application, the plane of the central part of the sensing module penetrates to define a vertical axis, and the vertical axis is parallel to the third direction, The projection points of the first direction and the second direction on the vertical axis are relative to the third direction. The flexible ECG detection device described in item 5 of the scope of patent application, wherein the fifth branch extends from the lower side of the central part, and the wire sequence of each signal detection unit is arranged on the fifth branch To form a wire integrated port, which is electrically connected with the signal collection module and the signal detection units. The flexible ECG detection device described in item 5 of the scope of patent application, wherein the first branch, the second branch, the third branch, and the fourth branch can be used to accommodate at least one signal detection device, respectively测unit. For the flexible ECG detection device described in the first item of the scope of patent application, the shielding layers are made of a flexible alloy composed of a flat surface or a mesh structure. As for the flexible ECG detection device described in item 1 of the scope of patent application, the compression method of the wire can be either spiral winding or folding. For example, the flexible ECG detection device described in item 7 of the patent application, the signal collection module further includes: a wire element with a first lead and a second lead; and a signal collection interface, It is electrically connected to the signal detection units through the wire element. For the flexible ECG detection device described in claim 11, the first lead is electrically connected to the lead integration port, and the second lead is electrically connected to the signal collection interface. The flexible ECG detection device described in item 11 of the scope of patent application, wherein the first lead is a female connector, and the second lead is a male connector.

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