CN110801219A

CN110801219A - Body surface bioelectric electrode holder, strip-shaped device and electrocardiogram measuring device

Info

Publication number: CN110801219A
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: Xinyun Heng'an 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: 2020-02-18
Anticipated expiration: 2039-11-18
Also published as: CN110801219B

Abstract

An electrode holder, comprising: a stent body; a plurality of support legs extending from the stent body, the distal ends of the support legs having electrode mounting portions for mounting bioelectric electrodes; a plurality of holder mounting means provided on the holder body for detachably attaching the electrode holder 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 parts correspond to the mounting positions of the human precordial electrocardiolead electrodes V1, V2 and V3.

Description

Body surface bioelectric electrode holder, strip-shaped device and electrocardiogram measuring device

Technical Field

The present invention relates generally to a belt-shaped device provided with an electrode holder and capable of being stably fixed to a chest, and more particularly, to an electrocardiograph electrode holder provided on a chest, a belt-shaped device for collecting an electrocardiograph, and an electrocardiograph measuring device.

Background

Electrocardiographic (ECG) devices are commonly used to perform electrocardiographic testing to provide information about the subject's cardiac function. When the electrocardio-electrode is used for collecting electrocardiosignals, the variability of the electrocardiogram lead position is an important reason for poor repeatability of the electrocardiogram amplitude measurement of the precordial lead, so that the fact that the placement position of the electrocardio-electrode is correct and stable is an important measure for collecting the electrocardiogram with high quality.

In order to obtain electrocardiosignals at any time, various wearable ECG devices are available. Typically, these ECG devices include some sort of strap or strip-shaped device, and, unless used in a hospital, the strap-shaped devices are not adapted to adhere directly to the skin of the test subject for comfort and reusability.

The belt-shaped device disclosed in chinese patent publication CN103190899A is directed to a depressed region formed between a chest of a human body and the belt-shaped device, and ensures that electrodes of the depressed region can be in good contact with the skin of a test person by using electrodes having different lengths. However, since the tape-shaped device is generally flexible, the electrodes having a certain length mounted on the tape-shaped device are easily forced to tilt with respect to the body of the tape-shaped device to cause the contact point to slip off a predetermined position.

In addition, for the electrocardiograph device provided with the conventional synchronous leads, the predetermined positions of the chest electrodes (precordial electrodes) corresponding to the leads V1 to V6 are respectively: v1 (where Vi represents both the lead and the electrode corresponding to each lead and its intended anatomical location, the same below), the right sternal margin, intercostal 4; v2, left sternal margin, intercostal 4; v3, which is the midpoint of the two-point connecting line of V2 and V4; v4, left mid-clavicular line, intersection with intercostal 5; v5, left anterior axillary line at the same level as V4; v6, left axillary midline at level V4. If these six points are connected in sequence, they will be roughly in a zigzag pattern on the plane. The ribbon device of CN103190899A is not suitable for being designed into a ribbon shape with a narrow width in order to adapt to the zigzag electrode layout.

US patent publication US2017215800a1 discloses a strip-shaped device for measuring electrical signals, such as heart beat, which is provided with 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, because the six conventional electrocardio leads are not designed, the belt body is equal in width and narrower. In addition, the belt-shaped device disclosed in US2017215800a1 attempts to attach a circuit box on the other side surface of the body-contacting surface of the belt-shaped device to perform functions such as processing, storage, and wireless transmission of bioelectrical signals. However, it has been found that the sliding of the belt-shaped device is more likely to occur in a moving state after the circuit box is attached due to the increase in weight.

There has also been attempted to provide a structure in which a lateral stripe or the like is provided on the surface of the belt-shaped device on the side close to the skin, with increased friction with 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 can be reused are increasingly applied to patients, health concerns, and various sporter targets. For wearable medical band-shaped devices that can be worn for extended periods of time, a narrower band body of equal width would improve the comfort of the target subject.

Disclosure of Invention

The invention aims to provide a belt-shaped device which is approximately equal in width and narrow in belt body, is conveniently expanded to synchronously measure at least six chest conventional electrocardio leads from V1 to V6, can stably contact a bioelectricity electrode aiming at a chest sunken area, can be worn for a long time to feel comfortable, and is not easy to slide the electrode away from a preset position even if worn for a long time. It is understood that by a narrower ribbon body in the present invention is meant that the width is insufficient to position the V1 through V6 electrocardioelectrodes in their respective predetermined anatomical locations, or, if the V1 through V6 electrocardioelectrodes are positioned in their respective predetermined anatomical locations, the maximum horizontal height difference between the electrodes will be greater than the width of the ribbon body.

The main aspects or main aspects of the invention are set forth explicitly in the claims. The inventive content is not solely defined by the claims. The invention is explained in more detail below with reference to the drawings. It is to be understood, however, that the following description, including the appended drawings, is intended merely to illustrate the invention in more detail, as defined in the appended claims, and not to limit its scope.

Drawings

Fig. 1 is a strip-shaped device according to an embodiment of the invention, which is presented in an asymmetrically folded fashion, on which no electrode holder has yet been arranged.

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

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

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

Fig. 5 is a view of the electrode holder from a perspective that is inclined from the inside to the outside, again to better understand the shape of the electrode holder.

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

Fig. 7 is another representation of the band device of fig. 1 folded twice to generally represent no three segments on which no electrode holders have been placed.

FIG. 8 is another embodiment of the present invention in the form of a strip-shaped device folded twice to generally assume no three sections on which no electrode holders have been placed.

Detailed Description

Fig. 1 shows a belt-shaped device 1 according to an embodiment of the invention. Generally, the band-shaped device 1 includes an elongated flexible band body 10 and a tie device 11 at an end of the band body 10. The entire length of the band-shaped device 1 is sufficient to be wrapped around the torso, e.g. the chest, of the user's body in order to be secured to the chest of the user. Generally, its length can be adjusted by a tie device 11 or other not shown device to adjust it to a length suitable for fixation to the user's chest. The belt body 10 includes at least one non-stretching section 12 to which an electrode holder (described in detail later) is detachably attached. In order to achieve a suitable degree of tensioning of the belt-shaped device 1 when being fastened to the chest of a user, the belt-shaped device 1 may preferably further comprise a stretch section 13 made of a stretchable material.

The belt body 10 has an inner side 14. The inner side, which in the present invention is meant to be the side of the band shaped device 1 that faces the skin of the chest when it is worn on the chest, follows this rule when describing the other components. A stent mounting portion 16 for mounting an electrode stent (described in detail below) of a precordial (precordial) bioelectric electrode such as a precordial (precordial) electrocardiographic electrode is provided on the inner side 14 of the non-stretching section 12. The rack mount 16 includes a plurality of rack receivers 17, with 4 rack receivers 17 being shown in FIG. 1.

The plurality of rack receivers 17 may be collectively disposed on the belt body or may be arranged linearly apart on the belt body, for example, in a horizontal or vertical line or in a line of other directions. Tests show that the strip body is easily deformed and displaced when the strip body is worn due to the excessively concentrated arrangement or the linear arrangement of the plurality of support receiving devices 17, so that the accuracy of the test is affected, and the deformation of the strip body can be improved due to the triangular or rectangular arrangement of the support receiving devices. Therefore, the number of the rack receiving devices 17 is preferably 3 or more. When the number of the stent receivers 17 is 3, the stent receivers are preferably arranged on the non-stretching sections 12 in a substantially triangular distribution; when the number of the rack receiving devices 17 is 4 or more, they are preferably arranged on the non-stretching sections 12 in a substantially rectangular distribution. Fig. 1 shows that 4 rack receivers 17 are arranged in a substantially rectangular shape on the inner side 14 of the non-stretched section 12 of the belt body 10.

One particular electrode holder 20 is shown in figures 2 to 5. Wherein FIG. 2 is a view of the electrode holder 20 as it would appear from a generally lateral elevational view; FIG. 3 is a cross-sectional view taken at A-A in FIG. 2; FIG. 4 is a view of the electrode holder 20 from another perspective, 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 a perspective that is inclined from the inside toward 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, the number of the holder mounting devices 23 is the same as that of the holder receiving devices 17 on the tape body 10, and the holder mounting devices 23 are arranged in the same layout so as to be in one-to-one correspondence and detachably coupled to each other. The rack mount 23 and the rack receiver 17 each include at least one electrical connector such that when joined together they are electrically connected. Preferably, the electrical connector is a resilient connection, whereby the stability of the electrical connection can be ensured. For example, and without limitation, the rack receiving means 17 may be a female snap of a snap, the rack mounting means 23 may be a male snap of a snap, or a male and female snap may be interchanged, and both the male and female snaps may be made of a conductive material such as metal, so that the electrical connector itself serves as the rack mounting means 23 and the rack receiving means 17. The electrode holder 20 further includes a plurality of support legs 22 extending from the holder body 21, a distal end of each support leg 22 having an electrode mounting portion 230, the electrode mounting portion 230 being detachably or partly detachably provided with the bioelectric electrode 30 by anchoring, welding, snap-fitting, or the like. Preferably, the electrode support 20 is provided with support legs 221, 222, 223 corresponding to the lead electrodes from V1 to V3. In addition, in order to facilitate stable binding of the electrode holder 20 to the chest, the plurality of support legs 22 may further include an auxiliary support leg 224 provided for the purpose of balance binding, and an electrode mounting portion 230 is also provided at a distal end of the auxiliary support leg 224, and in this application, the electrode mounting portion of the auxiliary support leg 224 may be generally referred to as an auxiliary electrode mounting portion 231, and the auxiliary electrode mounting portion 231 may also be provided with a bioelectric electrode 30, and in order to distinguish the bioelectric electrodes provided on the support legs 221, 222, 223, the bioelectric electrode may be sometimes referred to as a bioelectric electrode 31 in this application. It should be understood that, in addition to the function of balancing the stent when the stent is attached to the chest, the actual bioelectric signals can be obtained from the bioelectric electrodes 31, and the acquisition sources of the bioelectric signals can be enriched because the acquisition positions of the bioelectric signals are different from the positions of the bioelectric electrodes 30. The number of the auxiliary support legs 224 is not limited to one. The bioelectrical electrode 31 and the bioelectrical electrode 30 may be the same bioelectrical electrode, but may be different. For example, the bioelectric electrode 30 is a disposable detachable electrode, while the bioelectric electrode 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 lead 33 (as shown by a dotted line in fig. 2, the dotted line indicates that it may be disposed inside or inside the material of the electrode holder 20, and only one lead 33 is schematically shown in fig. 2), and the lead 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 adhesive, 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 improve the comfort of the electrode holder 20 when placed against the chest skin, a fabric material 29 (see fig. 5) or the like is attached to the inner side of the holder body 20, and the fabric material 29 or the like may cover the lead wires 33 provided along the inner side surface of the holder body 21. A cavity (or opening) 24 may be provided in a central portion of the holder body 21, the cavity 24 may reduce the weight and save material of the electrode holder 20, and in various embodiments, a bioelectrical acquisition 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. The axis L is slightly inclined or gradually inclined inward from the axis L to both side edges away from the axis L as viewed in a sectional plane of the electrode holder 20 perpendicular to the axis L. This is more clearly understood from the cross-sectional view of fig. 3 at line a-a in fig. 2. The magnitude of the inclination angle θ of the inclination is about 3 to 15 degrees, for example, about 3 degrees, 5 degrees, or 8 degrees. Of course, the inclination is not limited to a straight line, and the inclination may be inclined and extended toward the inner side. Further, in the preferred embodiment, each support leg 22 is also slightly inclined or gradually inclined inward from the holder body 21 to the distal end portion 230 of each support leg 22 where the electrode 30 is provided, such inclination being 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, the electrodes can be provided with slightly inwardly obliquely extending electrodes with respect to the plane of a section of the chest of the band-shaped device 1, whereby the electrodes can be brought into more stable contact with the skin on the chest. Furthermore, in order to reinforce the strength of the support leg 22, particularly the support legs 221, 222 of the uppermost mounted V1, V2 electrocardioelectrode, the support leg 22 preferably has a support leg reinforcing portion 25 protruding out of the plane of the outer side surface 26 of the stand body 21. The support leg reinforcement portion 25 protrudes outward in a triangular shape as a whole, or excessively protrudes outward in an arc shape, for example. It should be understood that since the support leg itself is inclined inward, the arc-shaped excessive outward protrusion described herein means that the support leg has a protrusion protruding from its main body portion.

Referring to fig. 6, in the above embodiment, when the electrode holder 20 is attached to the chest, the holder mounting area 27 (the rectangular frame-shaped area with the broken line in the drawing) of the holder body 21 for disposing the holder mounting device 23 is substantially covered by the body 10 of the band-shaped device 1, the electrode holder 20 is located at 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 a tendency of turning toward the outside with respect to the holder mounting area 27, which tends to cause the electrodes 30 located at the upper portion of the electrode holder 20 as a whole to be separated from the chest skin to cause poor electrode contact, which affects the acquisition of the bioelectric signal.

In order to suppress this tendency to rotate, in a preferred embodiment, the lower portion of the electrode holder 20 further includes a rotation tendency suppression portion (not shown). The turning tendency suppression portion may be, for example, a long bar or a long bar member extending downward from the holder body 21 in the direction of the axis L, or may be a V-shaped support member extending downward, or may be a protruding support portion on the inner side of one end of the electrode holder 20 body 21 near the abdomen. The turning tendency suppression portion may be formed integrally with the holder body 21, or may be formed separately and detachably, for example, by screwing, engaging, fitting, or the like to the holder body 21.

Returning to fig. 1, 3 electrodes 32 are horizontally arranged on the inner side surface 14 of the non-stretching section 12 so as to extend from one end where the holder mounting portion 16 is provided to the other end, and are positioned to correspond to the chest electrodes V4, V5, and V6, respectively, of the conventional ecg leads.

Fig. 7 shows the outer side 15 of the non-stretched section 12. A lead interface 18 is provided on lateral side 15. Preferably, but not limitatively, lead interface 18 is provided in the area of lateral side 15 corresponding to medial side 14 where cradle mount 16 is provided. A bioelectrical signal processing cartridge (not shown) is detachably attached to the lead interface 18. Of course, the lead interface 18 may also be provided on the inner side of the non-stretching 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 one of the connection pins 19 in the lead interface 18 by a not-shown wire (which is provided, for example, in or on the material layer of the tape body 10), each of the rack receiving devices 17 corresponding to the electrodes 30 on the electrode rack 20 is also electrically connected to a corresponding one of the connection pins 19 in the lead interface 18, and the bioelectric signals obtained by each electrode are sent to the bioelectric signal processing cartridge by mounting the electrode rack 20 to the rack receiving device 17, and finally, each of the

bioelectric electrodes

30, 32 is electrically connected to a corresponding one of the connection pins 19 in the lead interface 18.

The bioelectrical signal processing box can process the electrocardiosignals of the leads from V1 to V6 and transmit the electrocardiosignals to a PC terminal, a remote server or a mobile terminal by wire or wirelessly. The bioelectrical signal processing box can also be provided with a limb lead module to synchronously acquire limb lead electrocardiosignals. The lead interface 18 and the related contents of the bioelectrical signal processing cartridge are described in detail in the applicant's prior application such as chinese patent publication CN106889985A, the contents of which are incorporated herein by reference and will not be described herein again.

In another embodiment, as shown in fig. 8, the non-stretching section 12 of the belt body 10 of the belt-shaped device 1 can almost surround the chest, so that more electrodes 32 can be provided to synchronously acquire more chest position electrocardiosignals.

It should be understood that the detailed description of the invention is intended to be illustrative, but not limiting. For example, while the embodiments are directed to providing ECG measurement electrodes on a belt-type device, any of a variety of chest surface electrodes or sensors may be provided on a similar belt-type device. For example, the sensor may be an electromyographic sensor for measuring an electromyographic signal of a body surface, or other electrodes for measuring a bioelectrical signal of a human body or a sensor for detecting a mechanical signal of a human body, such as a heart sound sensor.

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

Claims

1. An electrode holder (20) comprising:

a holder body (21);

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

a plurality of holder mounting means (23) provided on the holder body for detachably attaching the electrode holder to the strip-shaped device (1);

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 human precordial electrocardiolead electrodes V1, V2 and V3.

2. The electrode holder of claim 1, wherein: the plurality of support legs include auxiliary support legs (224) which may act to balance the electrode support when the electrode support is strapped to the chest by the strap arrangement.

3. The electrode holder of claim 1, wherein: at least part of the support legs are inclined inwards from the bracket body to the far end of the bracket body.

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; or, the electrode support has a substantially vertical central axis (L), the overall shape is substantially symmetrical about the vertical central axis, and the electrode support is gradually inclined from the vertical central axis to the inner side away from the central axis.

5. The electrode holder of claim, wherein: the support legs are triangular or arc-shaped to excessively protrude outward.

6. The electrode holder of claim, wherein: the bioelectricity electrode is mounted on the electrode mounting portion.

7. A band-shaped device (1) suitable for being fixed to the chest of a human being, 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 a bioelectric signal processing cartridge is detachably attached; a bracket mounting part (16) for mounting the electrode bracket according to any one of claims 1 to 6 is arranged on the inner side surface (14) of the non-stretching section; preferably, the rack mount comprises a plurality of rack receiving means (17); more preferably, the number of the plurality of stand receivers is 4.

8. The ribbon apparatus of claim 7, wherein: the inner side surface of the non-stretching section is provided with bioelectricity electrodes (32) corresponding to the precordial electrocardio-electrodes V4, V5 and V6; or the length of the non-stretching section can be approximately around the chest of the human body, and the inner side surface of the non-stretching section is provided with bioelectricity electrodes (32) corresponding to the precordial electrocardioelectrodes V4, V5 and V6 and other bioelectricity electrodes.

9. Strip device according to claim 7 or 8, wherein: also included is a bioelectric signal processing cartridge removably attached to the lead interface.

10. A bioelectrical measuring device comprising the tape shaped device according to any one of claims 7-9; preferably, the bioelectricity is electrocardio.