WO2020096567A1

WO2020096567A1 - Electrocardiographic detection device

Info

Publication number: WO2020096567A1
Application number: PCT/US2018/059292
Authority: WO
Inventors: Kun-Hsi Tsai; Tzu-Chih Lin; Yi-Chia Ho
Original assignee: Vitalchains Corporation
Priority date: 2018-11-06
Filing date: 2018-11-06
Publication date: 2020-05-14

Abstract

An ECG detection device includes multiple protective layers and multiple signal detection units disposed between the protective layers. Each of the protective layer is made of a material with irreversible flexibility and includes multiple perforations. Each of the signal detection units includes an electrode configured for detecting electrical signals of a subject. The signal detection units are so disposed that the electrodes are exposed on the ECG detection device through the perforations.

Description

ELECTROCARDIOGRAPHIC DETECTION DEVICE

FIELD

[0001] The present disclosure generally relates to a biological information measuring device, and more particularly, to an electrocardiographic (ECG) detection device.

BACKGROUND

[0002] An electrocardiogram is a diagram showing the electrical activity of the heart. Due to the electrical potential variations produced by the heart, electrical signals can be reflected through the tissues surrounding the heart to the surface of the body. An ECG detection device can measure the electrical signals and generate the electrocardiogram accordingly. By examining abnormal features on the electrocardiogram, clinicians can identify certain cardiac orders.

[0003] Users of the ECG detection device may follow standard ECG measuring mechanisms (e.g., the standard 12-electrode or 3 -electrode ECG measurement) to detect the heart’s electrical activity by placing multiple electrodes on various parts of the human body. Commonly used standard ECG measuring mechanisms include attaching electrodes on suction balls and/or patch fixtures directly to the human body to perform signal measurements.

[0004] However, the suction balls and patch fixtures require manual attachment to the human body one by one. This process can be time consuming and affect emergency care performance.

SUMMARY

[0005] An objective of the various embodiments of the present disclosure is to provide a lightweight, compact, extendible and disposable ECG detection device that allows quick user setup.

[0006] In one aspect of the present disclosure, an ECG detection device is provided. The

ECG detection device includes multiple protective layers and multiple signal detection units disposed between the protective layers. Each of the protective layer is made of a material with irreversible flexibility and includes multiple perforations. Each of the signal detection units includes an electrode configured for detecting electrical signals of a subject. The signal detection units are so disposed that the electrodes are exposed on the ECG detection device through the perforations. [0007] In one aspect of the present disclosure, an ECG detection device is provided. The

ECG detection device includes a patch type sheet, multiple signal detection units, a wire unit and a signal collection unit. The patch type sheet is made of at least one material having irreversible flexibility. The signal detection units are formed in the patch type sheet. Each of the signal detection units includes a coiled wire and an electrode connected the coiled wire. The wire unit is electrically coupled to the patch type sheet through the coiled wires of the signal detection units. The signal collection unit is electrically coupled to the wire unit and configured for receiving electrical signals from the electrodes of the signal detection units through the wire unit.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Aspects of the exemplary disclosure are best understood from the following detailed description when read with the accompanying figures. Various features are not drawn to scale; dimensions of various features may be arbitrarily increased or reduced for clarity of discussion.

[0009] FIG. 1A is a front view of an electrocardiographic (ECG) detection device according to an exemplary embodiment of the present disclosure.

[0010] FIG. 1B is a schematic illustration showing an ECG detection device attached on a human body to detect ECG activities, in accordance with an exemplary embodiment of the present disclosure.

[0011] FIG. 2 shows the top perspective view of an ECG detection device in accordance with an exemplary embodiment of the present disclosure.

[0012] FIG. 3 shows the bottom perspective view of an ECG detection device in accordance with an exemplary embodiment of the present disclosure.

[0013] FIG. 4 illustrates an exploded view of an ECG detection device in accordance with an exemplary embodiment of the present disclosure.

[0014] FIG. 5 illustrates a top partial view of a patch type sheet of an ECG device in accordance with an exemplary embodiment of the present disclosure.

[0015] FIG. 6 is an exploded view of an electrode of a signal detection unit of an ECG device in accordance with an exemplary embodiment of the present disclosure. [0016] FIGS. 7 and 8 schematically illustrate different perspective of views of an electrode of a signal detection unit of an ECG device in accordance with an exemplary embodiment of the present disclosure.

DETAILED DESCRIPTION

[0017] The following description contains specific information pertaining to example embodiments in the present disclosure. The drawings in the present disclosure and their accompanying detailed description are directed to merely example implementations. However, the present disclosure is not limited to merely these example implementations. Other variations and implementations of the present disclosure will occur to those skilled in the art. Unless noted otherwise, like or corresponding elements among the figures may be indicated by like or corresponding reference numerals. Moreover, the drawings and illustrations in the present disclosure are generally not to scale, and are not intended to correspond to actual relative dimensions.

[0018] For the purpose of consistency and ease of understanding, like features are identified (although, in some examples, not shown) by numerals in the example figures. However, the features in different implementations may be differed in other respects, and thus shall not be narrowly confined to what is shown in the figures.

[0019] References to“one embodiment,”“an embodiment,” “example embodiment,”

“various embodiments,”“some embodiments,”“embodiments of the present disclosure,” etc., may indicate that the embodiment(s) of the present disclosure so described may include a particular feature, structure, or characteristic, but not every possible embodiment of the present disclosure necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase “in one embodiment,” or“in an example embodiment,” “an embodiment,” do not necessarily refer to the same embodiment, although they may. Moreover, any use of phrases like “embodiments” in connection with“the present disclosure” are never meant to characterize that all embodiments of the present disclosure must include the particular feature, structure, or characteristic, and should instead be understood to mean“at least some embodiments of the present disclosure” includes the stated particular feature, structure, or characteristic. [0020] The term“coupled” is defined as connected, whether directly or indirectly through intervening components, and is not necessarily limited to physical connections. The term “comprising,” when utilized, means“including, but not necessarily limited to”; it specifically indicates open-ended inclusion or membership in the so-described combination, group, series and the equivalent.

[0021] Additionally, for the purposes of explanation and non- limitation, specific details, such as functional entities, techniques, protocols, standard, and the like are set forth for providing an understanding of the described technology. In other examples, detailed description of well- known methods, technologies, system, architectures, and the like are omitted so as not to obscure the description with unnecessary details.

[0022] Referring to FIG. 1 A, a front view of an electrocardiogram (ECG) detection device according to an exemplary embodiment of the present disclosure is shown. As shown in FIG. 1 A, the ECG detection device includes a sensor module 1 and a signal collection module 2 The sensor module 1 and the signal collection module 2 may be separable or integrally formed. The sensor module 1 may include a patch type sheet 10 and multiple signal detection units 11. The patch type sheet 10 may be made of at least one material having irreversible flexibility. The signal detection units 11 are formed in (e.g., embedded in) the patch type sheet 10, with each including an electrode for detecting electrical signal(s) from the body of a subject (e.g., a human). Each signal detection unit 11 may further include a conductive wire connected to the electrode for transmitting the detected electrical signals. The signal collection module 2 may receive the electrical signals from the signal detection units 11 through the conductive wires. The electrical signals may be processed at the signal collection module 2 locally or be provided to a back-end device to generate an electrocardiogram.

[0023] The signal collection module 2 may include a wire unit 21 and a signal collection unit 22 The wire unit 21 may be electrically coupled to the patch type sheet 10 through the conductive wires of the signal detection units 11. The signal collection unit 22 may be electrically coupled to the wire unit 21 and configured for receiving the electrical signals from the electrodes of the signal detection units 11 through the wire unit 21.

[0024] One end of the wire unit 21 may include a first coupling port 211 and the other end of the wire unit 21 may include a second coupling port 212 The first coupling port 211 may be electrically coupled to the second coupling port 212 through a cable, a conductive wired structure or a direct attachment. The first coupling port 211 and the second coupled port 212 are adapted to be connected with the sensor module 1 and the signal collection unit 22, respectively. When the signal collection module 2 is connected to the sensor module 1 , the electrical signals detected by the signal detection units 11 can be collected by the first coupling port 211 and transmitted to the signal collection unit 22 through the second coupling port 212.

[0025] After receiving the electrical signals from the signal detection units 11 , the signal collection unit 22 may transmit the electrical signals through wired (e.g., a cable) or wireless (e.g., WiFi or Bluetooth®) connections to a display monitor or a mobile device (e.g., a laptop or a cell phone) to facilitate the subsequent ECG interpretations.

[0026] In the present embodiment, the patch type sheet 10 may include a central part CP, a first branch BR1 extended from the central part CP toward a first direction Dl, a second branch BR2 extended from the central part CP toward a second direction D2, a third branch BR3 extended from the central part CP toward a third direction D3, a fourth branch BR4 extended from the central part CP toward the third direction D3, and a fifth branch BR5 extended from a side of the central part CP. The third direction D3 may be parallel to a vertical axis VA defined on a plane of the patch type sheet 10 and passing through the central part CP, and the projections of the first direction Dl and the second direction D2 on the vertical axis VA may be opposite to the third direction D3.

[0027] As shown in FIG. 1 A, the first branch BR1 and the second branch BR2 are extended from the upper left portion and the upper right portion of the central part CP, respectively, and hence form a V-shape structure exhibiting a bilateral symmetry with respect to the vertical axis VA. With the V-shaped structure, the first and second branches BR1 and BR2 can be easily placed on or stretched toward the upper limbs (e.g., the arms or the axillary regions) of the subject when the central part CP of the patch type sheet 10 is attached on the chest of the subject.

[0028] The third branch BR3 and the fourth branch BR4 are extended from the lower left and lower right portions of the central part CP, respectively. In one embodiment, the lengths of the third branch BR3 and the fourth branch BR4 may be longer than that of the first branch BR1 and the second branch BR2 when the patch type sheet 10 is in an unstretched state. The third and fourth branches BR3 and BR4 are suitable for being placed on or stretched toward the lower limbs (e.g., the legs or the inguinal regions) of a subject when the central part CP of the patch type sheet 10 is attached on the chest of the subject. [0029] The central part CP may have a pair of curves symmetrically curving inward with respect to the vertical axis VA, so as to avoid covering the breast of a subject when the central part CP is attached on the chest of the subject.

[0030] The fifth branch BR5 may be extended from the lower side (e.g., middle bottom) of the central part CP and adapted to be connected with the signal collection module 2. Conductive wires of the signal detection unit 11 may electrically couple to the signal collection module 2 through the fifth branch BR5.

[0031] In one embodiment, the shape of the patch type sheet 10 may vary, as long as the patch type sheet 10 is able to accommodate all of the signal detection units 11.

[0032] Referring to FIG. 1B, a schematic illustration showing the ECG detection device attached on a human body 100 to detect ECG activities thereof, in accordance with an examplary embodiment of the present disclosure, is shown. As shown in FIG. 1B, when the ECG detection device is attached on the human body 100, most of the signal detection units 11 are substantially aligned with the standard 12-electrode ECG measuring positions. Each of the first branch BR1, the second branch BR2, the third branch BR3, and the fourth branch BR4 may be configured for accommodating one of the signal detection units 11 , so that the electrodes of the signal detection units 11 corresponding to the first to fourth branches BR1 to BR4 can be exposed on the ECG detection device and matched to the limbs of the subject when the central part CP of the patch type sheet 10 is attached on the chest of the subject.

[0033] To meet different body structures, the positions of the signal detection units 11 may be altered. Each position of the signal detection units 11 can be adjusted by stretching the patch type sheet 10. For example, the third and fourth branches BR3 and BR4 of the patch type sheet 10 can be lengthened to ensure that the electrodes of the signal detection units 11 exposed on the third and fourth branches BR3 and BR4 reach the desired positions on the legs of the subject.

[0034] In the preferred embodiment, as shown on Fig. 1A, signal detection units 11 have

10 electrodes. In more details, the first branch BR1 has one electrode, which is labeled as RA and positioned on the right upper arm (should be placed outwardly on the right shoulder, preferentially over bone rather than muscle), and the second branch BR2 has one electrode, which is labeled as LA and positioned on the left upper arm (should be placed outwardly on the left shoulder, preferentially over bone rather than muscle). The central part CP has six electrodes, which are labeled as VI, V2, V3, V4, V5 and V6 in accordance with their positions on chest of subject. The third branch BR3 has one electrode, which is labeled as RL and positioned on the right leg (should be placed below the umbilicus). The fourth branch BR4 has one electrode, which is labeled as LL and positioned on the left leg (should be place below the umbilicus).

[0035] Referring to FIG. 2 and FIG. 3, the top and bottom perspective views of the ECG detection device are shown. As illustrated in FIG. 2 and 3, at one end of the signal collection unit 22 is a coupling port 221, which is adapted to be connected with the second coupling port 212 of the wire unit 21. In the present embodiment, the coupling port 221 is a female terminal, and the second coupling port 212 is a male terminal. However, it is understood that the effect of reversing the male and female terminals can be equivalent.

[0036] At one end of the fifth branch BR5 of the patch type sheet 10 is a hub port 12. The hub port 12 is adapted to be connected with the first coupling port 211 of the wire unit 21, and is used to collectively transmit the electrical signals detected by the signal detection units 11.

[0037] Referring to FIG. 4, an exploded view of the ECG detection device in accordance with an examplary embodiment of the present disclosure is shown. In the present embodiment, the ECG detection device includes a sensor module 1. The sensor module 1 may include a patch type sheet 10 and multiple signal detection units 11 (e.g., ten signal detection units 11).

[0038] It is noted that although in FIG. 4 the sensor module 1 includes ten signal detection units 11, it is for illustration purposes only, not for limitation. The number of the signal detection units 11 can vary according to certain ECG measuring requirement s). For example, the sensor module 1 may include three signal detection units 11 to conform to the standard 3 -electrode ECG measuring mechanism.

[0039] Each of the signal detection units 11 may include a conductive wire 111 and an electrode 112. One end of each of the conductive wire 111 is connected to the electrode 112, with the other end connected to the hub port 12. When the patch type sheet 10 is stretched by an applied force, each conductive wire 111 can also be stretched. The conductive wire 111 can be retracted by spiral winding or folding. In one embodiment, the conductive wire 111 is a coiled wire.

[0040] The patch type sheet 10 may include a stack of layer structures, which contains at least one shield layer and at least one protective layer. The stack of layer structures is flexible and stretchable so that it can be applied to various body structures as desired.

[0041] As shown in FIG. 4, there are multiple shield layers 13 and protective layers 14 included in the patch type sheet 10. The signal detection units 11 may be disposed between the protective layers 14. The shield layers 13 may be disposed between the signal detection units 11 and the protective layers 14. With such arrangement, the shield layers 13 may cover the signal detection units 11 to shield the signal detection units 11 against electromagnetic interferences. The shield layers 13, the protective layers 14 and the signal detection units 1 lean be combined together by, for example, a hot pressing process or any other attaching process.

[0042] Different shield layers 13 may have identical shapes. The material of the shield layers 13 may have sufficient irreversible flexibility to adapt to various types of bending motions. With the irreversible flexibility, the shield layers 13 may not or not easily recover to its original shape after stretched. In one embodiment, the shield layers 13 is a planar or meshed structure made of flexible alloy.

[0043] Each shield layer 13 may include multiple holes 131 to accommodate the electrodes

112 of the signal detection units 11, so that the electrodes 112 are exposed on the ECG detection device through the holes 131. The positions of the holes 131 on the shield layers 13 may be arranged according to the standard ECG measuring positions (e.g., the standard 12-electrode or 3- electrode ECG measuring positions).

[0044] The protective layers 14 may be integrated correspondingly (e.g., aligning positions to overlap) and cover the shield layers 13 therewithin. The protective layers 14 may be made of material(s) with irreversible flexibility, such as silicon rubber. An applied force that exceeds the elastic limits of the shield layers 13 and the protective layers 14 may result in an irreversible deformation. With such feature, the protective layers 14 and the shield layers 13 can be properly and stably applied to various body structures.

[0045] Each of the protective layer 14 may include multiple perforations 141. The positions of the perforations 141 may substantially correspond to the positions of the holes 131 of the shield layer 13, so that the electrodes 112 of the signal detection units 111 are exposed through the protective layers 14 and the shield layers 13. In other words, the signal detection units 111 are so disposed that the electrodes 112 are exposed on the ECG detection device through the holes 131 and the perforations 141.

[0046] In one embodiment, the perforations 141 at the top of the protective layer 14 may have protective covers 142 for protecting the electrodes 112. The protective covers 142 and the protective layer 14 can be integrally formed or separable. In one embodiment, each protective cover 142 may be labeled with different colors, icons, texts or the combination thereof, to indicate the corresponding standard ECG measuring positions.

[0047] It is noted that although in FIG. 4 the patch type sheet 10 includes two shield layers

13, the present disclosure is not limited thereto. In one embodiment, the patch type sheet 10 may not include the shield layers 13, so that the signal detection units 11 are directly covered by the protective layers 14. In one embodiment, the patch type sheet 10 may include only one shield layer 13 at the top side or the lower side of the signal detection units 11. In one embodiment, the shield layer 13 and the protective layer 14 may have different shapes. For example, one or more of the shield layers 13 may only cover a certain area (e.g., the fifth branch BR5) of the patch type sheet 10.

[0048] Referring to FIG. 5, a top partial view of the patch type sheet 10 in accordance with an examp lary embodiment of the present disclosure is shown. As shown in FIG. 5, the shield layer 13 (marked with diamond girds) and the protective layer 14 are correspondingly integrated. One end of a signal detection unit 11 is an electrode 112 and the other end is connected to the hub port 12. Between the electrode 112 and the hub port 12 is a conductive wire 111 (e.g., a coiled wire). Each hole 131 on the shield layer 13 is aligned with an electrode 112, so that the electrode 112 is exposed on the ECG detection device.

[0049] Refer to FIGS. 6 to 8. FIG. 6 is an exploded view of the electrode 112 of the signal detection unit 11 in accordance with an examplary embodiment of the present disclosure are shown. FIGS. 7 and 8 schematically illustrate different perspective of views of the electrode 112.

[0050] As shown in FIGS. 6 to 8, the electrode 112 includes a metal base 1111, a plate

1121, a film 1122, a protective cover 142 and a gel layer 1124.

[0051] The material of the plate 1121 and the film 1122 may be plastic or other insulator materials. In the present embodiment, the plate 1121 has a round shape and is connected to the metal base 1111. The metal base 1111 is connected to one end of the conductive wire 111. The base area of the plate 1121 is larger than that of the metal base 1111. The plate 1121 is further connected to the film 1122. The protective cover 142 can be installed on the top of the metal base 1111 to encapsulate the metal base 1111. The base surface of the plate 1121 is exposed to one side of the film 1122. The gel layer 1124 is coated on one side of the film 1122 and along the edge of the plate 1121, so that the plate 1121 can detect ECG electrical signals through the gel layer 1124 when contacting the body. [0052] It is noted that although in FIGS. 6 to 8 the electrode 112 is substantially in a round shape, one of ordinary skill in the art may appreciate that the electrode 112 may vary in shape according to the practical applications.

[0053] From the above description it is manifest that various techniques can be used for implementing the concepts described in the present application without departing from the scope of those concepts. Moreover, while the concepts have been described with specific reference to certain implementations, a person of ordinary skill in the art would recognize that changes can be made in form and detail without departing from the scope of those concepts. As such, the described implementations are to be considered in all respects as illustrative and not restrictive. It should also be understood that the present application is not limited to the particular implementations described above, but many rearrangements, modifications, and substitutions are possible without departing from the scope of the present disclosure.

Claims

WHAT IS CLAIMED IS:

1. An electrocardiographic (ECG) detection device comprising:

a plurality of protective layers, each of the protective layers being made of a material with irreversible flexibility and comprising a plurality of perforations; and

a plurality of signal detection units disposed between the protective layers, each of the signal detection units comprising an electrode being configured for detecting electrical signals of a subject,

wherein the signal detection units are so disposed that the electrodes are exposed on the ECG detection device through the perforations.

2. The ECG detection device according to claim 1 , wherein the material is silicon rubber.

3. The ECG detection device according to claim 1, further comprising:

a plurality of shield layers disposed between the protective layers and the signal detection units and configured for shielding the signal detection units against electromagnetic interferences; and each of the signal detection units further comprising a conductive wire connected to the electrode,

wherein each of the shield layers comprises a plurality of holes corresponding to the perforations of the protective layers, so that the electrodes are exposed on the ECG detection device through the holes and the perforations.

4. The ECG detection device according to claim 3, wherein each of the shield layers is a planar or meshed structure made of flexible alloy.

5. The ECG detection device according to claim 3, wherein the conductive wires are retracted by spiral winding or folding.

6. The ECG detection device according to claim 5, wherein the conductive wires are coiled wires.

7. The ECG detection device according to claim 3, further comprising: a hub port electrically coupled to another end of the conductive wires.

8. The ECG detection device according to claim 7, further comprising:

a wire unit comprising a first coupling port and a second coupling port, wherein the first coupling port is adapted to be connected to the hub port; and

a signal collection unit, adapted to be connected to the second coupling port of the wire unit and configured for receiving electrical signals from the signal detection units.

9. The ECG detection device according to claim 8, wherein the first coupling port is a female terminal and the second coupling terminal is a male terminal.

10. An electrocardiogram (ECG) detection device comprising:

a patch type sheet made of at least one material having irreversible flexibility;

a plurality of signal detection units formed in the patch type sheet, each of the signal detection units comprising a coiled wire and an electrode connected to the coiled wire;

a wire unit electrically coupled to the patch type sheet through the coiled wires of the signal detection units; and

a signal collection unit electrically coupled to the wire unit and configured for receiving electrical signals from the electrodes of the signal detection units through the wire unit.

11. The ECG detection device according to claim 10, wherein the patch type sheet comprises a plurality of protective layers, and a material of the protective layers is silicon rubber.

12. The ECG detection device according to claim 11, wherein the patch type sheet further comprises:

a plurality of shield layers disposed between the protective layers and the signal detection units and configured for shielding the signal detection units against electromagnetic interferences.

13. The ECG detection device according to claim 12, wherein each of the shield layers is a planar or meshed structure made of flexible alloy.

14. The ECG detection device according to claim 10, wherein the patch type sheet comprises: a central part;

a first branch extended from the central part toward a first direction;

a second branch extended from the central part toward a second direction;

a third branch extended from the central part toward a third direction;

a fourth branch extended from the central part toward the third direction; and

a fifth branch extended from a side of the central part.

15. The ECG detection device according to claim 14, wherein each of the first branch, the second branch, the third branch, and the fourth branch is configured for accommodating one of the signal detection units.

16. The ECG detection device according to claim 14, wherein the third direction is parallel to a vertical axis defined on a plane of the patch type sheet and passing through the central part, and projections of the first direction and the second direction on the vertical axis is opposite to the third direction.

17. The ECG detection device according to claim 16, wherein the first branch and the second branch form a V-shaped structure.

18. The ECG detection device according to claim 17, wherein the central part comprises a pair of curves symmetrically curving inward with respect to the vertical axis.

19. The ECG detection device according to claim 14, wherein the fifth branch comprises a hub port electrically coupled to the coiled wires.

20. The ECG detection device according to claim 10, wherein the wire unit comprises:

a first coupling port adapted to connect the hub port; and

a second coupling port adapted to connect the signal collection unit.