CN110801219B

CN110801219B - Body surface bioelectric electrode support, belt-shaped device and electrocardiograph measuring device

Info

Publication number: CN110801219B
Application number: CN201911125709.3A
Authority: CN
Inventors: 郭军; 陈韵岱; 石亚君; 韩宝石; 陈韬; 王晋丽; 陈力恒; 王平; 王进亮
Original assignee: Cardiocloud Medical Technology Beijing Co ltd
Current assignee: Cardiocloud Medical Technology Beijing Co ltd; First Medical Center of PLA General Hospital
Priority date: 2019-11-18
Filing date: 2019-11-18
Publication date: 2023-05-09
Anticipated expiration: 2039-11-18
Also published as: CN110801219A

Abstract

An electrode holder, comprising: a bracket body; a plurality of support legs extending from the stent body, distal ends of the support legs having electrode mounting portions for mounting bioelectrodes; a plurality of stent mounting means provided on the stent body for detachably attaching the electrode stent to the band-shaped means; a plurality of electrical connection wires for electrically connecting one of the electrode mounting portions to one of the plurality of rack mounting devices, respectively; the positions of three of the electrode mounting portions correspond to the mounting positions of the human chest electrocardiograph lead electrodes V1, V2, V3.

Description

Body surface bioelectric electrode support, belt-shaped device and electrocardiograph measuring device

Technical Field

The present invention relates generally to a belt-shaped device provided with an electrode holder and stably fixed to the chest, and more particularly to an electrocardiographic electrode holder provided to the chest, a belt-shaped device for acquiring electrocardiographs, and an electrocardiograph.

Background

Electrocardiographic (ECG) devices are commonly used to perform electrocardiographic measurements to provide information about the heart function of a subject. When the electrocardio electrode is used for acquiring electrocardiosignals, the variability of the position of an electrocardiogram lead is an important reason for poor repeatability of the amplitude measurement of the electrocardiogram of the lead, so that ensuring the correct placement position of the electrocardio electrode and keeping stable is an important measure for acquiring the electrocardiograms with high quality.

In order to facilitate obtaining electrocardiosignals at any time, various wearable ECG devices are currently available. Typically, these ECG devices include some sort of belt or strip-shaped device, and, unless used in a hospital setting, generally strip-shaped devices are not suitable for direct adhesion to the skin of the tester for comfort and reusability.

The strip-shaped device disclosed in chinese patent publication CN103190899a ensures that the electrodes of the recessed area can be in good contact with the skin of the tester by using electrodes of different lengths for the recessed area formed between the chest of the human body and the strip-shaped device. However, since the strip-shaped device is generally flexible, the electrode having a certain length mounted on the strip-shaped device is easily inclined with respect to the body of the strip-shaped device by force so that the contact point slides away from the predetermined position.

Further, for an electrocardiograph device provided with conventional synchronous leads, the predetermined positions of the chest electrodes (precordial electrodes) corresponding to the respective leads V1 to V6 are respectively: v1 (where Vi represents both the leads and the electrodes corresponding to the leads and their predetermined anatomical locations, the same applies below), the right sternum is between the 4 th rib; v2, the left edge of the sternum is between the 4 th intercostals; v3 is the midpoint of the connecting line between the two points of V2 and V4; v4, the intersection between the left collarbone midline and the 5 th intercostal; v5, left anterior axillary line level with V4; v6, left axillary midline level with V4. If the six points are connected in sequence, the six points are approximately in a Z-shaped pattern on a plane. The ribbon device of CN103190899a is not suitable for being designed into a ribbon shape of equal width and narrower in order to accommodate the zigzag electrode layout.

US patent publication US2017215800A1 discloses a strip-shaped device for measuring an electrical signal, such as a heartbeat, which provides an anti-slip structure around the electrodes, which helps to reduce the deviation of the strip-shaped device and its electrodes from a predetermined position. Meanwhile, the belt body is equal in width and narrower as the design is not carried out for six conventional electrocardiograph leads. In addition, the tape device disclosed in US2017215800A1 also attempts to attach a circuit box on the other side surface of the tape device that contacts the body to perform functions such as processing, storage, and wireless transmission of bioelectric signals. However, it was found that the attachment of the circuit box more easily caused the sliding of the belt-shaped device in a moving state due to the increased weight.

There have also been attempts to provide a structure in which friction force between the belt-shaped device and the skin is increased, such as a lateral stripe, on a surface of the belt-shaped device on the side close to the skin, but the improvement effect is not significant.

With the development of internet medical treatment, wearable medical devices that can be worn for a long time and that can be reused are increasingly being applied to patients, to health care caregivers, and to various athlete targets. For wearable medical ribbon devices that can be worn for extended periods of time, an equally wide and narrower ribbon body would improve the comfort of the target subject.

Disclosure of Invention

The invention aims to provide a belt-shaped device with a belt body which is approximately equal in width and narrower, is convenient to expand to synchronously measure at least six chest conventional electrocardiograms including V1 to V6, can stably contact with a chest depression area, can be worn for a long time to feel comfortable, and is not easy to slide away from a preset position after being worn for a long time. It will be understood that by narrower band body in this invention is meant that the width is insufficient to place each of the V1 to V6 electrocardiographs in a predetermined anatomical position corresponding to each electrocardiograph electrode, or that if each of the V1 to V6 electrodes is positioned in a predetermined anatomical position, the maximum level difference between each electrode will be greater than the width of the band body.

The main content or main technical solutions of the invention are explicitly stated in the claims. But the summary is not merely what is claimed. The invention is explained in more detail below with reference to the drawings. It should be understood that the following description includes drawings for the purpose of illustrating the invention in more detail, and is not intended to limit the scope of the invention.

Drawings

Fig. 1 is a ribbon-shaped device of an embodiment of the present invention, asymmetrically folded once, without an electrode holder disposed thereon.

Fig. 2 is a view showing the electrode holder of the present invention from the outside.

Fig. 3 is a cross-sectional view at A-A in fig. 2.

Fig. 4 is a view of the electrode holder from another view generally from the outside to better understand the shape of the electrode holder.

Fig. 5 is a view of the electrode holder from an oblique angle generally from the inside to the outside, again to better understand the shape of the electrode holder.

Fig. 6 is a partial view of the strip device 1 when the electrode holder is mounted on the strip device 1.

Fig. 7 is another version of the strip device of fig. 1 folded twice to generally assume a non-three section configuration without an electrode holder disposed thereon.

Fig. 8 is a strip-shaped device according to another embodiment of the invention, which is folded twice to substantially show no three sections, on which no electrode holder has been provided.

Detailed Description

Fig. 1 shows a belt-shaped device 1 according to an embodiment of the invention. Generally, the strip-shaped device 1 comprises an elongated flexible strip body 10 and a tie-down device 11 at the end of the strip body 10. The entire length of the strip-shaped device 1 is sufficient to be wound around the trunk of the user's body, for example the chest, in order to fix it to the user's chest. Typically, its length may be adjusted by the tie-down device 11 or other means not shown to adjust it to a length suitable for securing to the chest of the user. The belt body 10 includes at least one non-stretch section 12 to which an electrode holder (described in greater detail below) is removably attached. In order to achieve a suitable degree of tightening of the band-shaped device 1 when secured to the chest of the user, the band-shaped device 1 may preferably further comprise a stretch section 13 made of stretchable material.

The belt body 10 has an inner side 14. The inner side, i.e. the side of the band-shaped device 1 facing the skin of the chest when worn on the chest, which is referred to in the present invention also follows this rule when describing other components. A holder mounting portion 16 for mounting an electrode holder (described in detail below) of a precordial (chest) bioelectric electrode, such as a precordial (chest) bioelectric electrode, is provided on the inner side 14 of the non-stretch section 12. The rack mount 16 includes a plurality of rack receiving devices 17, of which 4 rack receiving devices 17 are shown in fig. 1.

The plurality of rack receiving devices 17 may be disposed together on the belt body or may be disposed apart in a straight line on the belt body, for example, in a straight line in a horizontal or vertical line or in another direction. Experiments show that a plurality of support receivers 17 are arranged too intensively or in a straight line, which easily deform and displace the belt body during wear, affecting the accuracy of the test, while a triangular or rectangular arrangement of the support receivers can improve the deformation of the belt body. Therefore, the number of the rack receiving devices 17 is preferably 3 or more. When the number of stent receivers 17 is 3, it is preferably arranged in a substantially triangular distribution on the non-stretch section 12; when the number of stent receivers 17 is 4 or more, they are preferably disposed in a substantially rectangular distribution on the non-stretch section 12. Fig. 1 shows that 4 stent receivers 17 are arranged in a generally rectangular fashion on the inner side 14 of the non-stretch section 12 of the band body 10.

Fig. 2 to 5 show a specific electrode holder 20. Wherein fig. 2 is a view of the electrode holder 20 in general from the outside in elevation; FIG. 3 is a cross-sectional view taken at A-A of FIG. 2; fig. 4 is a view of the electrode holder 20 from another view generally from the outside to better understand the shape of the electrode holder 20; fig. 5 is a view of the electrode holder 20 from an oblique angle generally from the inside to the outside, again to better understand the shape of the electrode holder 20.

See fig. 2 to 5. The electrode holder 20 includes a holder body 21, a plurality of holder mounting devices 23 are provided on the holder body 21, and the holder mounting devices 23 are identical in number and in the same layout as the holder receiving devices 17 on the belt body 10 so as to be detachably combined with each other in one-to-one correspondence. The bracket mounting means 23 and the bracket receiving means 17 each comprise at least one electrical connector such that when combined together they are electrically connected. Preferably, the electrical connector is an elastic connection, whereby stability of the electrical connection can be ensured. Without limitation, for example, the bracket receiving means 17 is a snap-on female, the bracket mounting means 23 is a snap-on male, or a snap-on female and both male and female are interchanged, and both male and female are made of an electrically conductive material, such as metal, so that the electrical connector itself now serves as the bracket mounting means 23 and the bracket receiving means 17. The electrode holder 20 further includes a plurality of support legs 22 extending from the holder body 21, and a distal end of each support leg 22 has an electrode mounting portion 230, the electrode mounting portion 230 being detachably or partially detachably provided with the bioelectric electrode 30 by means of anchoring, welding, snap-fitting, or the like. Preferably, the electrode holder 20 is provided with

support legs

221, 222, 223 corresponding to the V1 to V3 lead electrodes. In addition, in order to facilitate stable binding of the electrode supporter 20 to the chest, the plurality of support legs 22 may further include auxiliary support legs 224 provided for binding balance, the distal ends of the auxiliary support legs 224 may also be provided with electrode mounting portions 230, in this application, the electrode mounting portions of the auxiliary support legs 224 may also be generally referred to as auxiliary electrode mounting portions 231, and the auxiliary electrode mounting portions 231 may also be provided with bioelectrodes 30, which are sometimes referred to herein as bioelectrodes 31 in order to distinguish the bioelectrodes provided on the

support legs

221, 222, 223. It should be understood that, in addition to functioning as a balance support when the support is tied to the chest, the actual bioelectric signal may be obtained from the bioelectric electrode 31, and the collection location may be different from that of the bioelectric electrode 30, so that the collection sources of the bioelectric signals may be enriched. The number of auxiliary support legs 224 is not limited to one. Bioelectrode 31 may be the same bioelectrode as bioelectrode 30, but may also be different. For example, bioelectrode 30 is a disposable detachable electrode, while bioelectrode 31 is a reusable detachable or partially detachable electrode. Of course, both electrode 31 and electrode 30 may be reusable electrodes. The bioelectric electrode 30 is electrically connected to the electrical connector of the electrode mounting device 23 by a wire 33 (shown by a dotted line in fig. 2, the dotted line indicates that it may be disposed inside or on the inner side of the material of the electrode holder 20, only one wire 33 is schematically shown in fig. 2), the wire 33 may be disposed along the surfaces of the support leg 22 and the holder body 21 by attaching a conductive film, printing a conductive paste, or the like, or may be formed inside the material of the support leg 22 and the holder body 21 when the holder body 21 and the support leg 22 are molded or 3D printed. In an alternative embodiment, to enhance the comfort of the placement of the electrode holder 20 against the chest skin, a fabric material 29 (see fig. 5) or the like is attached to the inside surface of the holder body 20, and the fabric material 29 or the like may cover the leads 33 disposed along the inside surface of the holder body 21. A cavity (or opening) 24 may be provided in the central portion of the holder body 21, the cavity 24 may reduce the weight of the electrode holder 20 and save material, and in various embodiments, a bioelectric collection and/or processing module may be provided in the cavity or opening 24.

The electrode holder 20 has a substantially vertical central axis L, and the overall shape is substantially symmetrical about the axis L. From the axis L to the edges on both sides away from the axis L, the electrode holder 20 is slightly or gradually inclined to the inner side as seen in a sectional plane perpendicular to the axis L. This is more clearly understood from the cross-sectional view at line A-A in fig. 2, fig. 3. The magnitude of the inclined inclination angle θ is about 3 to 15 degrees, for example, about 3 degrees, 5 degrees, 8 degrees. Of course, the inclination is not limited to a straight line, and may be an inward arc. Furthermore, in the preferred embodiment, each support leg 22 is also slightly or gradually inclined inward from the holder body 21 toward the distal end portion 230 of the placement electrode 30 of each support leg 22, which inclination is clearly shown in fig. 2, 4 or 5. By such a design, in the case where the electrode holder 20 is attached to the chest by the band-shaped device 1, each electrode can be provided with an electrode extending obliquely slightly inward with respect to the plane in which a section of the chest of the band-shaped device 1 lies, whereby the electrode can be brought into contact with the skin in the chest more stably. In addition, in order to strengthen the support leg 22, particularly the

support legs

221, 222 on which the V1, V2 electrocardio-electrodes are mounted uppermost, the support leg 22 preferably has a support leg strengthening portion 25 protruding from the plane in which the outer side surface 26 of the holder body 21 lies. The support leg reinforcing portion 25 protrudes outward in a triangular shape as a whole, or protrudes outward excessively in an arc shape, for example. It should be understood that since the support legs themselves are inclined inwardly, the excessive outward projection in the form of an arc as described herein means that the support legs have projections protruding from the main body portion thereof.

Referring to fig. 6, in the above-described embodiment, when the electrode holder 20 is attached to the chest, the holder body 21 is provided with the holder mounting region 27 (the broken line rectangular frame-like region in the drawing) of the holder mounting device 23 substantially covered by the body 10 of the band-shaped device 1, the electrode holder 20 is located on the upper portion of the band-shaped device 1 as a whole, and the upper portion 28 of the electrode holder 20 is liable to generate an outward rotational tendency with respect to the holder mounting region 27, which causes the electrodes 30 located on the upper portion of the electrode holder 20 as a whole to be liable to come off the chest skin to generate poor electrode contact, affecting the acquisition of bioelectric signals.

In order to suppress this rotational tendency, in a preferred embodiment, the lower portion of the electrode holder 20 further includes a rotational tendency suppressing portion (not shown). The rotation tendency suppressing portion may be, for example, a long condition or a long rod extending in the axis L direction from the holder body 21 to the lower portion, or may be a V-shaped support extending to the lower portion, or may be a protruding support portion on the inner side of the electrode holder 20 body 21 near the abdomen portion. The rotation tendency suppressing portion may be integrally formed with the holder body 21, or may be formed in such a manner as to be detachably attached to the holder body 21 after being separately manufactured, for example, by screwing, snap-fitting, or the like.

Returning to fig. 1, on the inner side 14 of the non-stretch section 12, extending from one end to the other end where the stent mount 16 is provided, 3 electrodes 32 are also arranged horizontally in positions corresponding to the chest electrodes V4, V5, V6 of the conventional leads of an electrocardiogram, respectively.

Fig. 7 shows the outer side 15 of the non-stretch section 12. A guide opening 18 is provided in the outer side 15. Preferably, but not limited to, the lead interface 18 is disposed in an area of the outer side 15 of the corresponding inner side 14 where the bracket mounting portion 16 is disposed. A bioelectric signal processing cartridge (not shown) is detachably attached to the lead coupling port 18. Of course, the lead-in connection 18 may also be provided on the inner side of the non-stretch section 12, for example at a location corresponding to the cavity 24 of the electrode holder 20 when the electrode holder 20 is attached to the tape body 10. Each electrode 32 on the tape body 10 is electrically connected to a corresponding connection pin 19 in the lead-in port 18 through a lead wire (not shown) provided in or on the material layer of the tape body 10, for example, and each holder receiving means 17 corresponding to the electrode 30 on the electrode holder 20 is also electrically connected to a corresponding connection pin 19 in the lead-in port 18, and finally, each

bioelectric electrode

30, 32 is electrically connected to a corresponding connection pin 19 in the lead-in port 18 by mounting the electrode holder 20 to the holder receiving means 17, and the bioelectric signal obtained by each electrode is sent to the bioelectric signal processing box.

The bioelectric signal processing box can process the electrocardiosignals of each lead V1 to V6 and send the electrocardiosignals to a PC terminal, a remote server or a mobile terminal through wires or wirelessly. The bioelectric signal processing box can also be provided with a limb lead module to synchronously acquire limb lead electrocardiosignals. The relevant contents of the lead interface 18 and bioelectric signal processing cartridge are described in detail in applicant's prior applications, such as chinese patent publication CN106889985a, the contents of which are incorporated herein by reference and are not repeated here.

In another embodiment, as shown in fig. 8, the non-stretched section 12 of the belt body 10 of the belt-shaped device 1 can be wound almost around the chest for one week, so that more electrodes 32 can be provided to acquire more chest position electrocardiographic signals simultaneously.

It should be understood that the detailed description and specific examples, while indicating the invention, are intended to be illustrative rather than limiting. For example, although the embodiment is provided with ECG measuring electrodes on a strip device, any of a variety of chest body surface electrodes or sensors may be provided on a similar strip device. For example, it may be a myoelectric sensor for measuring a body surface myoelectric signal, or other electrode for measuring a body bioelectric signal or a sensor for detecting a body mechanical signal, such as a heart sound sensor.

The invention has significant advantages. The electrode of the band-shaped device can be stably and reliably contacted with the skin when the band-shaped device is fixed on the chest, the band-shaped device can be comfortably supported, so that the band-shaped device can be worn for a long time, and is not easy to slide even if a circuit module is attached and is in a motion state, thereby remarkably improving the repeatability, the effectiveness and the accuracy of a test signal.

Claims

1. An electrode holder (20), comprising:

a bracket body (21);

a plurality of support legs (22) extending from the stent body, the distal ends of the support legs having electrode mounting portions (230, 231) for mounting bioelectric electrodes (30, 31);

a plurality of stent mounting means (23) disposed within a stent mounting region (27) on the stent body for detachably attaching the electrode stent to the tape-shaped device (1);

a rotation tendency suppressing section for suppressing a rotation tendency of an upper portion of the electrode holder to an outside with respect to the holder mounting area when the electrode holder is bound in front of the chest by the band-shaped means, which is provided at a lower portion of the electrode holder;

a plurality of electrical connection wires (33) for electrically connecting one of the electrode mounting portions to one of the plurality of rack mounting devices, respectively;

the positions of three of the electrode mounting parts correspond to the mounting positions of the chest electrocardiograph lead electrodes V1, V2 and V3 of the human body;

the plurality of support legs includes auxiliary support legs (224) that are not support legs for the electrodes V1, V2, V3 of the electrocardiograph lead, for balancing the electrode support when the electrode support is strapped to the chest by the strap-like device.

2. The electrode holder of claim 1, wherein: the distal end of the support leg (224) is provided with an auxiliary electrode mounting portion provided with a bioelectric electrode (31).

3. The electrode holder of claim 1, wherein: the plurality of support legs have at least a portion of the support legs that taper inwardly from the stent body to the distal end thereof.

4. The electrode holder of claim 1, wherein: the electrode holder has a substantially vertical central axis (L) about which the overall shape is substantially symmetrical; alternatively, the electrode holder has a substantially vertical central axis (L), the overall shape is substantially symmetrical about the vertical central axis, and the electrode holder is gradually inclined from the vertical central axis to an axially inner side away from the central axis.

5. The electrode holder of claim 1, wherein: the support leg has a support leg reinforcing portion (25) protruding from a plane in which an outer side surface of the bracket body is located.

6. The electrode holder of claim 1, wherein: the bioelectric electrode is arranged on the electrode mounting part.

7. A band-shaped device (1) suitable for being fixed to the chest of a human body, comprising a band body (10), characterized in that it comprises: a non-stretching section (12) on which a lead interface (18) is provided, to which the bioelectric signal processing cartridge is detachably attached; a holder mounting portion (16) for mounting the electrode holder according to any one of claims 1 to 6 is provided on an inner side surface (14) of the non-stretching section.

8. The ribbon apparatus of claim 7, wherein: the rack mount includes a plurality of rack receiving devices (17).

9. The ribbon device of claim 8, wherein: the number of the plurality of bracket receiving devices is 4.

10. The ribbon apparatus of claim 7, wherein: bioelectric electrodes (32) corresponding to the chest electrocardiographic electrodes V4, V5 and V6 are arranged on the inner side surface of the non-stretching section; alternatively, the length of the non-stretching section can be approximately round the chest of a human body, bioelectric electrodes (32) corresponding to the chest electrocardio electrodes V4, V5 and V6 are arranged on the inner side surface of the non-stretching section, and other bioelectric electrodes are also arranged.

11. The tape device according to any one of claims 7-10, wherein: a bioelectric signal processing cartridge detachably attached to the lead interface is also included.

12. A bioelectric measurement device comprising a tape device according to any of claims 7-11, wherein the bioelectric is an electrocardiograph.