Adaptor
The patch-type electrocardiograph with a reusable terminal and disposable adapter addresses the issues of Holter ECG monitors by providing a cost-effective and user-friendly wearable device for continuous electrocardiogram measurement.
Patent Information
- Application Number
- PCT/JP2024/030427
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-08-27
- Publication Date
- 2026-03-05
AI Technical Summary
Existing wearable electrocardiogram devices, such as Holter ECG monitors, are cumbersome and costly due to the need for multiple electrodes and wiring, posing a burden on users and requiring high initial investment.
A patch-type electrocardiograph design comprising a reusable terminal and disposable electrode adapter with a unique connector and wiring arrangement that reduces thickness and simplifies attachment, allowing for cost-effective and comfortable wear.
The design minimizes user burden and reduces costs by enabling a more comfortable, easier-to-wear device with lower operational expenses.
Smart Images

Figure JP2024030427_05032026_PF_FP_ABST
Abstract
Description
adapter
[0001] The present invention relates to a wearable device that measures a subject by attaching sensors such as electrodes to the subject's body.
[0002] The number of patients with heart disease in Japan is increasing year by year, and for early detection, continuous long-term electrocardiogram waveform measurement in daily life is necessary. For this reason, progress is being made in the development of wearable devices that can measure electrocardiogram waveforms not only in hospitals and facilities but also in patients' daily lives at home. For example, Holter electrocardiographs, such as those described in Non-Patent Document 1, are commercially available as such wearable devices.
[0003] Holter ECG monitors are suitable for long-term measurement because they can provide stable measurements even when the wearer moves. However, Holter ECG monitors require wiring and multiple electrodes to be attached in the correct positions, which can be a significant burden on the user when worn and can be uncomfortable to wear. Furthermore, they cost several hundred thousand yen, which poses a cost issue.
[0004] The above problem can be solved by configuring the electrocardiograph as a patch-type electrocardiograph consisting of a terminal and an adapter with electrodes. Figure 7 shows an example of the configuration of a patch-type electrocardiograph. The patch-type electrocardiograph consists of a terminal 50 and an adapter with electrodes 10.
[0005] The terminal 50 is a device that processes biosignals measured by the electrode unit and wirelessly transmits them to an external device. The electrode-equipped adapter 10 includes connector units (20-1, 20-2), electrodes (30-1, 30-2), wiring units (40-1, 40-2), and a flexible base material 11, and includes an adhesive base material 12 in areas other than the electrodes that come into contact with the skin.
[0006] The connectors (20-1, 20-2) of the electrode adapter 10 are paired with and detachable from the connectors (60-1, 60-2) of the transmitter 50. The connectors may be configured with snap buttons such as American snaps.
[0007] In a patch-type electrocardiograph, the terminal 50 is reusable and the electrode adapter 10 is a disposable mass-produced product, so costs can be reduced compared to a Holter electrocardiograph. Furthermore, compared to a Holter electrocardiograph, a patch-type electrocardiograph is smaller and easier to wear because it only needs to be attached to a part of the body, making it possible to realize a wearable device with high usability.
[0008] Promed Technology Co., Ltd., “PRODUCTS”, “Holter ECG”, [accessed August 19, 2024], Internet <URL: https: / / www.promed-tech.com / a / products / lm1 / 169.html>
[0009] However, the operation of disposable electrode adapters does not sufficiently reduce the running costs for users, and further cost reduction measures are desired.
[0010] The present invention aims to provide a wearable device that places little burden on users.
[0011] In order to solve the above problems, the adapter of the present invention includes a first connector portion and a second connector portion for attaching a terminal that processes and wirelessly transmits a biosignal measured by an electrode portion, a third connector portion and a fourth connector portion for attaching an electrode portion for contacting a living body, a first flexible wiring portion for electrically connecting the first connector portion and the third connector portion, a second flexible wiring portion for electrically connecting the second connector portion and the fourth connector portion, and a wiring board for connecting the first connector portion, the second connector portion, and the third connector portion. and the fourth connector portion are arranged in a straight line, and a flexible substrate in which the first flexible wiring portion and the second flexible wiring portion are arranged, wherein the distance between the third connector portion and the fourth connector portion is longer than the distance between the first connector portion and the second connector portion, the first connector portion and the second connector portion are arranged on the side of the flexible substrate where the terminal is attached, and the third connector portion and the fourth connector portion are arranged on the side of the flexible substrate where the electrode portion is attached.
[0012] According to the present invention, a wearable device can be provided that places little burden on users.
[0013] Fig. 1 is a cross-sectional view of an example configuration of a wearable device including an adapter according to a first embodiment of the present invention. Fig. 2 is a diagram showing an example configuration of the adapter according to the first embodiment of the present invention. Fig. 3 is a diagram showing an example configuration of a connector according to the first embodiment of the present invention. Fig. 4 is a diagram for explaining a procedure for wearing a wearable device including an adapter according to the first embodiment of the present invention. Fig. 5 is a cross-sectional view of an example configuration of a wearable device including an adapter according to a second embodiment of the present invention. Fig. 6 is a diagram for explaining a procedure for wearing a wearable device including an adapter according to the second embodiment of the present invention. Fig. 7 is an example configuration of a conventional patch-type electrocardiograph.
[0014] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described in detail below with reference to the accompanying drawings. The present invention can be implemented in various embodiments and is not limited to the embodiments described below.
[0015] First Embodiment Configuration of Adapter FIG. 1 is a cross-sectional view showing an example of the configuration of a wearable device equipped with an adapter according to a first embodiment of the present invention.
[0016] A wearable device equipped with the adapter 10 of this embodiment is composed of a terminal 50, the adapter 10, an electrode unit 2, and an adhesive substrate 12 for adhering to the skin of a living body 1. The wearable device equipped with the adapter 10 of this embodiment is configured so that the terminal 50 and the electrode unit 2 can be detached via a connector installed on the adapter 10. In addition to the terminal 50, the adapter 10 can be reused, making it possible to provide a wearable device at a low cost to the user.
[0017] The terminal 50 is a device that processes the biological signals measured by the electrode unit and wirelessly transmits them to an external device. The terminal 50 includes connector units (60-1, 60-2) for connecting to the adapter 10.
[0018] The adapter 10 includes a flexible substrate 11, connector sections (first connector section, second connector section, third connector section, fourth connector section) (20-1 to 20-4), and flexible wiring sections (40-1, 40-2) that electrically connect the connector sections. The connector sections (20-1 to 20-4) are aligned in a straight line. The distance between the connector section (20-3) and the connector section (20-4) is longer than the distance between the connector section (20-1) and the connector section (20-2). For example, the former is about 10 cm, and the latter is about 5 cm.
[0019] The adapter 10 comprises a flexible substrate 11 and a flexible wiring section disposed inside the flexible substrate 11 and connecting the connector sections, and is configured so that the adapter 10 bends toward the living body 1 when the terminal 50 is attached.
[0020] The flexible substrate 11 may be made of, but is not limited to, silicone rubber, polyethylene, expanded polyethylene, polyimide, PET, PP, or the like.
[0021] Examples of the connector parts (20-1 to 20-4) include, but are not limited to, snap buttons such as American snaps. Magnetic hooks and the like may also be used instead of snap buttons. The arrangement of the recesses and protrusions in the connector parts is also not limited to that shown in the drawings.
[0022] The flexible wiring portions (first flexible wiring portion, second flexible wiring portion) (40-1, 40-2) may be made of, but are not limited to, an Ag / AgCl sheet, silver paste, copper foil, conductive fabric, or the like.
[0023] The electrode unit 2 includes electrodes (first electrode, second electrode) (30-1, 30-2) for measuring biosignals, connector units (70-1, 70-2) for connecting to the adapter 10, and an adhesive substrate 12 for adhering to the skin of the living body 1. Common, commercially available conductive gel electrodes can be used as the electrodes (30-1, 30-2). The electrode unit 2 may also include supports (13-1, 13-2) for supporting the connector units (70-1, 70-2).
[0024] The adhesive base material 12 is a double-sided adhesive tape for use in a living body, and is arranged in an area other than the electrode unit 2 that comes into contact with the skin, for adhering the adapter 10 and the electrode unit 2 to the living body 1. The adhesive base material 12, which is arranged on the surface of the central part of the adapter 10 facing the living body, is intended to keep the adapter 10 in a bent state by adhering it to the skin of the living body 1.
[0025] The connector parts (20-1, 20-2) are arranged facing the side where the terminal 50 is attached, and the connector parts (20-3, 20-4) are arranged facing the living body 1, i.e., the side where the electrode part 2 is attached. When the terminal 50 is attached, the connector parts (20-1, 20-2) are pushed into the living body 1, and the flexible base material 11 and the flexible wiring parts (40-1, 40-2) of the adapter 10 are configured to bend toward the living body 1, as shown in FIG.
[0026] In the adapter 10 of this embodiment, the flexible substrate 11 and the flexible wiring sections (40-1, 40-2) are bent, thereby reducing the overall thickness of the adapter 10. Furthermore, by attaching the central bottom of the adapter 10 to the living body 1 using a double-sided adhesive tape 12 for living bodies, the adapter 10 can be fixed to the living body 1, and the terminal 50 can be configured to not wobble when attached.
[0027] 2 illustrates the change in thickness of the adapter 10 due to the bending of the flexible substrate 11 and the flexible wiring portion (40-2) in the portion where the connector portions (20-2, 20-4) are arranged. The portion where the connector portions (20-2, 20-4) of the adapter 10 are arranged has a three-layer structure of flexible substrate 11 / flexible wiring portion / flexible substrate 11. The flexible wiring portion is arranged between the first flexible substrate and the second flexible substrate.
[0028] 2, the above-described three-layer structure is flat before the adapter 10 is bent. At this time, the overall thickness of the adapter 10 is (thickness of the flexible substrate / flexible wiring section / flexible substrate) + (thickness of the recessed portion at the top of the connector x 2).
[0029] On the other hand, as shown in the right diagram of Figure 2, when the connector portion (20-2) is pushed toward the living body 1, the flexible substrate 11 and the flexible wiring portion (40-2) bend, and the thickness of the entire adapter 10 decreases by the thickness of the recess at the top of the connector compared to before bending.
[0030] 3 is a diagram illustrating the configuration of the connector according to the first embodiment of the present invention. As shown in FIG. 3, the connector portions (20-1 to 20-4) are composed of upper (recessed) and lower (base) members, and can be fabricated by bonding the upper (recessed) and lower (base) members together. Electrical conduction between the connectors is achieved by contacting the flexible wiring portions (40-1, 40-2) with the lower base portions of the connector portions (20-1 to 20-4).
[0031] In the three-layer structure of flexible substrate / wiring section / flexible substrate of the adapter 10, an opening is formed in the flexible substrate 11. The bases of the lower parts of the connector sections (20-1 to 20-4) fit into this opening, thereby bringing the lower parts of the connector sections (20-1 to 20-4) into contact with the flexible wiring sections (40-1, 40-2). By fitting the bases of the lower parts of the connector sections (20-1 to 20-4) into the openings formed in the flexible substrate 11, it is possible to realize an adapter 10 that can achieve a reduction in thickness when bent.
[0032] <Procedure for Wearing the Adapter> Fig. 4 is a diagram for explaining the procedure for wearing a wearable device equipped with an adapter according to the first embodiment of the present invention. The procedure for wearing a wearable device equipped with adapter 10 of this embodiment is as follows.
[0033] (Step S1-1): Attach electrodes (electrodes with connectors) to the adapter. (Step S1-2): Attach electrodes (electrodes with connectors) to the adapter. (Step S1-3): Attach double-sided adhesive tape for biological use to the center bottom of the adapter. (Step S1-4): Attach the terminal to the adapter. (Step S1-5): Attach the integrated wearable device (terminal / adapter / electrodes) to the skin of the living body. (Step S1-6): Flex the adapter to bring the entire adapter into close contact with the skin.
[0034] In the above attachment procedure, steps S1-1 to S1-4 can be performed in any order. The electrode unit 2 may be attached to the adapter 10 after the terminal 50 is attached to the adapter 10. In the first embodiment, the electrode unit 2 and the adhesive base material 12 arranged on the central surface of the adapter 10 facing the living body are separate, so when attaching the adapter 10 to the skin of the living body 1, all three pieces of double-sided adhesive tape 12 for living bodies must be in close contact with the skin.
[0035] 5 is a cross-sectional view showing an example of the configuration of a wearable device equipped with an adapter according to a second embodiment of the present invention. The difference from the first embodiment is that the electrode unit 2 and the double-sided adhesive tape 12 for living bodies, which is disposed at the center bottom of the adapter 10, are integrated.
[0036] The electrode unit 2 of this embodiment includes electrodes (30-1, 30-2) for measuring biological signals, connector units (70-1, 70-2) for connecting to the adapter 10, and a double-sided adhesive tape 12 for use in contact with the skin of the living body 1, and the electrode unit 2 and the double-sided adhesive tape 12 are integrated by a support 13.
[0037] In this embodiment, a component can be formed in which the electrode unit 2 and the double-sided adhesive tape for biological use 12 are integrated by using a common base, the support 13, which serves as a common support for each electrode of the electrode unit 2, and attaching the double-sided adhesive tape for biological use 12 at the center bottom of the adapter 10 to both sides of the support 13. This configuration makes it possible to reduce the number of components and the number of steps required for attachment compared to the first embodiment.
[0038] The support 13 is made of a material that is less stretchable and flexible than the flexible base material 11. By using a material with less stretchability and flexibility for the support 13, it becomes possible to maintain the bent state of the adapter 10 when the adapter 10 is bent and the bottom part is attached to the double-sided adhesive tape for living organisms 12.
[0039] <Procedure for Wearing the Adapter> Figure 6 is a diagram for explaining the procedure for wearing a wearable device equipped with an adapter according to the second embodiment of the present invention. The procedure for wearing a wearable device equipped with adapter 10 of this embodiment is as follows: (Step S2-1): Attach the electrode unit integrated with the adapter. (Step S2-2): Flex the adapter to attach the bottom of the adapter to the double-sided adhesive tape for living bodies. (Step S2-3): Attach the terminal to the adapter. (Step S2-4): Attach the integrated wearable device (terminal / adapter / electrodes) to the skin of the living body.
[0040] In the above-described attachment procedure, step S2-3 may be performed before steps S2-1 and S2-2. In the second embodiment, since the electrode part 2 and the double-sided adhesive tape 12 for biological use are integrated, the number of attachment steps can be reduced by two compared to the first embodiment.
[0041] Although the present invention has been described above with reference to the embodiments, the present invention is not limited to the above-described embodiments. Various modifications that can be understood by those skilled in the art can be made to the configuration of the present invention within the scope of the present invention.
[0042] Some or all of the above-described embodiments can be described as, but are not limited to, the following supplementary notes.
[0043] [Supplementary Note 1] A device comprising: a first connector portion and a second connector portion for attaching a terminal that processes and wirelessly transmits a biosignal measured by an electrode portion; a third connector portion and a fourth connector portion for attaching an electrode portion for contacting a living body; a first flexible wiring portion for electrically connecting the first connector portion and the third connector portion; a second flexible wiring portion for electrically connecting the second connector portion and the fourth connector portion; and a flexible base material in which the first connector portion, the second connector portion, the third connector portion, and the fourth connector portion are aligned in a straight line and in which the first flexible wiring portion and the second flexible wiring portion are disposed; wherein the distance between the third connector portion and the fourth connector portion is longer than the distance between the first connector portion and the second connector portion; and the first connector portion and the second connector portion are disposed on the side of the flexible base material to which the terminal is attached; The adapter according to Supplementary Note 1, wherein the third connector portion and the fourth connector portion are arranged on the side of the flexible substrate to which the electrode portion is attached. [Supplementary Note 2] The adapter according to Supplementary Note 1, wherein the first connector portion and the second connector portion each have a recess for connecting the terminal and a base for electrically connecting with the first flexible wiring portion, and the third connector portion and the fourth connector portion each have a recess for connecting the electrode portion and a base for electrically connecting with the first flexible wiring portion, and the bases are fitted into openings formed in the flexible substrate. [Supplementary Note 3] The adapter according to Supplementary Note 1, wherein the flexible substrate includes a first flexible substrate on the side to which the terminal is attached and a second flexible substrate on the side to which the electrode portion is attached, and the first flexible wiring portion and the second flexible wiring portion are arranged between the first flexible substrate and the second flexible substrate.
[0044] 10...adapter, 11...flexible substrate, 12...adhesive substrate, 13, 13-1, 13-2...support, 20-1 to 20-4...connector portion (concave), 30-1, 30-2...electrodes, 40-1, 40-2...flexible wiring portion, 50...terminal, 60-1, 60-2...connector portion, 70-1, 70-2...connector portion (convex).
Claims
1. A device comprising: a first connector portion and a second connector portion for attaching a terminal that processes and wirelessly transmits a biosignal measured by an electrode portion; a third connector portion and a fourth connector portion for attaching an electrode portion for contacting a living body; a first flexible wiring portion for electrically connecting the first connector portion and the third connector portion; a second flexible wiring portion for electrically connecting the second connector portion and the fourth connector portion; and a flexible substrate on which the first connector portion, the second connector portion, the third connector portion, and the fourth connector portion are aligned in a straight line and in which the first flexible wiring portion and the second flexible wiring portion are disposed; wherein the distance between the third connector portion and the fourth connector portion is longer than the distance between the first connector portion and the second connector portion; and the first connector portion and the second connector portion are disposed on the side of the flexible substrate on which the terminal is attached; The adapter, wherein the third connector portion and the fourth connector portion are arranged on the side of the flexible substrate where the electrode portion is attached.
2. An adapter as described in claim 1, wherein the first connector portion and the second connector portion each have a recess for connecting the terminal and a base for electrically connecting with the first flexible wiring portion, and the third connector portion and the fourth connector portion each have a recess for connecting the electrode portion and a base for electrically connecting with the first flexible wiring portion, and the bases are fitted into openings formed in the flexible base material.
3. An adapter as described in claim 1, wherein the flexible substrate comprises a first flexible substrate on the side to which the terminal is attached and a second flexible substrate on the side to which the electrode portion is attached, and the first flexible wiring portion and the second flexible wiring portion are arranged between the first flexible substrate and the second flexible substrate.
Citation Information
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