CN110680309B

CN110680309B - Chest belt-shaped device and electrocardiogram measuring device

Info

Publication number: CN110680309B
Application number: CN201911116748.7A
Authority: CN
Inventors: 陈韵岱; 郭军; 韩宝石; 石亚君; 王晋丽; 陈韬; 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: 2019-11-15
Filing date: 2019-11-15
Publication date: 2023-04-07
Anticipated expiration: 2039-11-15
Also published as: CN110680309A

Abstract

A band-shaped device (1) suitable for being fixed to the chest, comprising: a support (4) to prevent the band-shaped device from sliding downwards when being fastened on the chest. The circuit module (90) for processing the electrocardiosignals can be arranged in the supporting part (4), so that the design of the strip-shaped device can be more flexible.

Description

Chest belt-shaped device and electrocardiogram measuring device

Technical Field

The present invention relates generally to a belt-shaped device (muscle) provided with electrodes or sensors and stably fixed on the chest, and more particularly, to an electrocardiograph belt-shaped device and an electrocardiograph measuring device provided on the chest.

Background

Electrocardiographic (ECG) devices are commonly used to perform electrocardiographic testing to provide information about the subject's cardiac function.

In order to obtain electrocardiosignals at any time, various wearable ECG devices are available. Typically, these ECG devices comprise 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. However, it is important to fix the electrocardiographic electrodes accurately and stably at predetermined positions on the skin surface of a human body in order to obtain an accurate electrocardiogram.

All the patent publications CN103190899a, which have been transferred to the present applicant, disclose a belt-shaped device for a depressed area formed between the chest of a human body and the belt-shaped device, and good contact of electrodes with the skin of a tester in such a depressed area is ensured by using electrodes having different lengths.

It is often necessary to acquire electrocardiographic signal data for a long time in a moving state such as a walking state. However, in practical use, it is found that in a motion state, particularly in a long-time motion state, the conventional belt-shaped device fixed on the chest slides, and the electrocardio-electrode deviates from a preset position, so that the acquired electrocardio-signal cannot be used for normal medical diagnosis. The electrocardiograph electrode disclosed in CN103190899a is easy to slide away from a predetermined position along with the sliding of the tape device during long-term use.

The strip-shaped device disclosed in US patent publication 2017215800A1, which places a slip-resistant structure around the electrodes, helps to reduce the deviation of the strip-shaped device and its electrodes from a predetermined position.

In addition, the belt-shaped device disclosed in US2017215800A1 attempts to provide a circuit box on the other side surface of the belt-shaped device, which is in contact with the body, to perform the functions of processing, storing, and wirelessly transmitting electrocardiographic 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 a structure in which a lateral stripe or the like is provided on the skin-proximal side surface of the belt-shaped device to increase the friction force with the skin, but the improvement effect is not significant.

In addition to concern about sweating and the like easily affecting the operation of the circuit, it is considered inappropriate to provide the circuit board on the skin-side of the tape device.

Disclosure of Invention

The inventor has noticed that the belt-shaped device is easy to slide in the standing or moving state due to the tendency of the chest to gradually shrink from the breast to the bottom, the existence of the chest concave area mentioned in the aforementioned chinese patent publication CN103190899a, or the gravity action of the additional circuit box and the friction action between the additional circuit box and the clothes.

The invention aims to provide a wearable belt-shaped device which is not easy to slide during sports, thereby improving the accuracy of detecting various bioelectric signals. In addition, various circuit modules can be conveniently arranged on the belt-shaped device, and a good anti-skid effect is kept.

Overall, the present invention is completely unconventional, placing the signal processing circuit module as a support on the skin-proximal side of the belt-shaped device and at the location of the depressed area corresponding to the middle of the chest when positioned correspondingly to the chest, unexpectedly finding that the sliding of the belt-shaped device is effectively prevented even in a moving state.

In a particular embodiment, a band-shaped device adapted to be secured to a chest includes: a support portion provided on a surface of the band-shaped device, the surface being a side surface of the band-shaped device that faces the skin of the chest when the band-shaped device is fixed to the chest.

Preferably, the support is provided at a position corresponding to a depressed area in the middle of the chest when the band-shaped device is secured to the chest.

Preferably, the aforementioned support comprises a housing made of a polymeric material. Preferably, the surface of one surface of the shell, which is in contact with the skin, is provided with fine grains; or a fabric material is attached to the surface of the shell, which is in contact with the skin.

In an alternative embodiment, the aforementioned support is a bag made of fabric, the inside of which is filled with a yielding material. In an alternative embodiment, the support portion is formed of a deformable material.

Preferably, the thickness of the support portion is gradually reduced from the abdomen-side to the neck-side when the band-shaped device is fixed to the chest.

In a preferred embodiment, the support portion is provided with a circuit module. Generally, the circuit module includes one or more modules of a battery, a wireless transmission module, or a scalable lead electrode signal interface. Particularly preferably, the circuit module is arranged within the support, for example within the housing.

It is another object of the present invention to provide a bioelectrical measuring apparatus comprising the tape-shaped device of any of the above-described aspects.

The invention also provides an electrocardio measuring device which comprises the belt-shaped device in any form.

Since the support portion effectively blocks the sliding of the worn belt-shaped device, the belt-shaped device can favorably prevent the electrodes on the belt-shaped device from deviating from the predetermined positions, even without providing a special anti-slip structure for the electrodes on the belt-shaped device, thereby facilitating the detection of bioelectricity. Other further advantages or advantages are further described in conjunction with the following figures and detailed description.

Drawings

Fig. 1 is a front view schematically showing a conventional ECG strip device.

Figure 2 is a schematic view of the contour of a human chest with a concave area to be formed between a strap-shaped device placed on the chest and pulled flat.

FIG. 3 is a schematic illustration of the general shape assumed by the recessed area of FIG. 2 when the front chest of the test subject is viewed from the front of the test subject.

Fig. 4 is a partial view of the band-shaped device of the present invention having a support portion.

FIG. 5 is a graph of the quality of the support part obtained by the test and the test yield.

Detailed Description

Referring to fig. 1, a band-shaped device 1 is used for placing on a patient in a substantially chest position for ECG measurements. The band-shaped device 1 comprises a band body 10 and two

end portions

12 and 13, the band body 10 being overall elongate, that is to say having a length from the first end portion 12 on the left to the second end portion 13 on the right which is substantially greater than its width. Generally, the overall length of the band-shaped device 1 may be around the torso, e.g. the chest, of the user's body. Wherein the

end portions

12 and 13 are further made of a stretchable material in one embodiment in order to adjust the degree of fastening of the band-shaped device 1 to the torso of the body.

The belt body 10 is generally a non-conductive flexible belt body, and may be a single layer structure or a laminated multi-layer structure, and the material of the layer may be various fabrics, rubber, plastic films, etc. When a multilayer structure is used, the materials of the layers may be the same or different, but preferably the layer in contact with the skin is a good-feel fabric or a material containing a portion of a fabric.

A plurality of electrode setting parts 3 are provided on the belt body 10 at predetermined positions corresponding to the human body, and a plurality of electrodes 2 for ECG measurement are provided in the electrode setting parts 3. The electrodes 2 may be electrode setting parts 3 fixedly arranged on the belt body 10, or electrode position adjusting structures capable of adjusting the electrode positions may be arranged on each or some of the electrodes 2 on the belt body 10 to adapt to slight changes of preset positions of testers with different body shapes and ages.

The electrode 2 may be any of a variety of electrodes suitable for placement on a tape-like device, such as a patch electrode, a chuck electrode, a cylindrical electrode.

Fig. 2 is a diagram exemplarily showing a contour shape of a human chest cross section. The cross-sectional shape of the skin contour surrounding the human chest 100 is not outwardly convex in every segment, particularly the cross-sectional contour of the skin 101 in the middle portion of the anterior chest exhibits a pronounced concavity into the thoracic cavity. When the band-shaped device 1 is fixed on the chest of the subject, a significant concave area 110 is formed between the band body 10 of the band-shaped device 1 and the skin 101 of the middle portion of the front chest.

Fig. 3 shows the general shape assumed by the depressed region 110 when the front chest of the tester is viewed from the front of the tester in a plane. Referring also to fig. 1, regarding the recessed area 110 of the anterior chest portion, since the contours of the right breast 102 and the left breast 103 are symmetrically distributed in a substantially circular arc shape near the middle of the anterior chest portion, the recessed area 110 is wider on the side closer to the abdomen side 14 and narrower on the side closer to the neck side 15, so that the recessed area 110 as a whole takes a triangular shape as indicated by a dashed-line frame 115 in fig. 3. When the band-shaped device 1 is straightened and fixed to the anterior chest portion, the area of the anterior chest portion contacting the band-shaped device 1 on the abdominal portion side 14 side is small, and the area of the anterior chest portion contacting the band-shaped device 1 on the neck portion side 15 side is large, whereby the support of the anterior chest portion on the abdominal portion side 14 side of the band-shaped device 1 is relatively smaller than the support on the neck portion side 15 side, and the support stability is deteriorated on the abdominal portion side 14 side. In the case where the trunk is in an upright state, the belt-shaped device 1 is easily slid down, i.e., toward the abdomen due to the action of gravity and friction of the clothes, so that the electrodes are deviated from the predetermined positions, and the test result is deteriorated.

Fig. 4 shows an embodiment of the present invention to solve the sliding of the belt-shaped device. At the position of the corresponding recessed area 110 when the band-shaped device 1 is positioned to the chest, a support 4 is provided on the side facing the skin of the chest. When the support portion 4 is provided, the belt-shaped device 1 is fixed to the anterior chest portion, and the support on the abdominal portion side 14 side is increased, thereby having an effect of preventing the belt-shaped device 1 from sliding from the chest portion toward the abdominal portion. And, because the form that adopts the supporting part prevents to slide, compare and adopt forms such as viscose to fix the belt shape device at tester's chest more convenient health, also make tester's comfort level obtain improving, in addition, also be favorable to the used repeatedly of belt shape device.

The shape of the support 4 is preferably adapted to the deepest depression 111 (see fig. 3) of the depression area 110 and the depression surface around it. The support 4 is in stable contact with the chest skin and has a large contact area due to the adaptation to the deepest recess 111 and the recess surface around it. More preferably, the lower edge of the support portion is brought into contact with the slightly raised abdominal skin below the deepest recess 111, and the slip-down of the band-shaped device 1 can be more effectively prevented. The support portion 4 may be non-detachably fixed to the belt-shaped device 1, but is preferably detachably attached to the belt-shaped device 1 in a fixed form such as a hook and loop fastener, a buckle, or the like. The material of the housing 5 of the support 4 may be a polymer material such as Polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), or a blend of ABS and PC, and in this case, the surface contacting the skin is preferably provided with a surface treatment structure such as a fine texture, e.g., a cross-grain structure, which increases friction. Alternatively, a fabric layer may be applied to the skin-contacting surface of the housing 5 to enhance comfort. Alternatively, the entire housing 5 may be made of fabric, and the support 4 may be made of a material that is easily deformable, such as sponge.

Since the circumference of the human breast generally shows a tendency to taper down from the breast down, which is particularly evident for women, the depth of the recessed area 110 increases towards the abdominal area, so that in one embodiment the thickness h of the support 4, i.e. the height at which the support 4 protrudes from the surface of the band-shaped device 1, preferably tapers down from the lower part of the support 4, i.e. towards the abdominal side 14, to the upper part of the support 4, i.e. towards the neck side 15, i.e. towards the abdominal side 14 is greater than the thickness towards the neck side 15. For example, the upper part of the support 4 appears as a line 41, while the lower part of the support 4 appears as a curved surface 42.

In a preferred embodiment, a circuit module 90 including a processing module (not shown) for processing, storing, and wirelessly transmitting the cardiac electric signal to a server, a mobile terminal device, or the like, and an internal battery (not shown) for supplying power to the processing module may be installed in the support portion 4. The electrodes 2 provided on the tape main body 10 are guided to the circuit module 90 by a lead wire (not shown) attached to the surface of the tape main body 10 or a lead wire (not shown) interposed in the interlayer of the tape main body 10 made of a multilayer material. The circuit module 90 may also include an expandable lead electrode signal interface (not shown) to expand the number of leads or channels tested. By embedding the circuit module 90 inside the support portion 4, the belt-shaped device 1 can be supported well, and the design of the belt-shaped device can be more flexible and the circuit module 90 can be protected well because the circuit module does not need to be considered to be fixed in other areas of the belt-shaped device. It is also apparent that the circuit module 90 is not limited to the above-described functions, and circuits including other functions, or other suitable components other than the circuits may be provided in the support portion 4 as long as necessary. At this time, in order to prevent sweat, for example, from affecting the circuit module 90, the housing 5 of the support portion 4 is preferably made of the aforementioned polymer material.

Taking the detection of an electrocardiographic signal as an example, the offset of the electrode position relative to a predetermined position during electrocardiographic detection is generally required to be less than or equal to 1cm. Four kinds of trial belt-shaped devices, in which no supporting part (GroupI) is provided, the lower part of the supporting part is not in contact with the skin (GroupI) slightly raised from the abdomen at the lower part of the deepest recessed part 111, the lower part of the supporting part is in contact with the skin (GroupIII) slightly raised from the abdomen, the lower part of the supporting part is in contact with the skin (GroupI) slightly raised from the abdomen, and a circuit module (grouiv) with the weight of 70g is arranged in the supporting part, are tested, the belt-shaped devices with proper length are attached to a human-simulated robot (female) in a non-loose and non-tight manner and surround the chest of the human-simulated robot for one circle, then two end parts 12 and 13 (shown in figure 1) of the belt-shaped devices are bonded, and when the human-simulated in-situ walking posture is worn, the robot is allowed to respectively walk 1000 steps, 3000 steps, 5000 steps and 10000 steps in a laboratory, and then the offset of the belt-shaped devices relative to a preset position is measured. And defining that the offset is less than or equal to 1cm as qualified and more than 1cm as unqualified. For each Group (Group), the number of steps of 1000 steps, 3000 steps, 5000 steps and 10000 steps was measured 100 times, and the number of times of passing in the 100 times was defined as the passing rate of the belt-shaped device in the exercise state (number of walks), and the measurement results are shown in table 1.

TABLE 1

It can be seen from table 1 that the provision of the support portion can significantly reduce the possibility of the tape device deviating from the predetermined position, thereby improving the accuracy of the measurement result. For example, in the case where no support portion is provided, the offset amount is only qualified after 5000 steps of walking, and the result is only good, while the qualified number is increased to 95 times after the support portion is provided, and particularly in the case where an additional circuit module is provided in the support portion, which has a considerable weight, the measurement result is unexpectedly very good, and reaches an excellent level of 97 times (after 10000 steps of walking).

With this unexpected result, we believe that this is probably related to the total mass of the support 4 containing the circuit module 90. The total mass of the support 4 was varied by varying the mass of the circuit module 90 while varying the degree of tightening of the band-shaped device to the body surface and repeating the above test, the results of which are shown in fig. 5. It was found through experiments that the maximum yield could be obtained at the position where the mass is M (in grams), the yield decreased slightly as M decreased, decreased as M increased gradually, and decreased sharply as M exceeded a certain value. This shows that the mass of the support 4 is not linearly dependent on the position of the belt-shaped device due to slippage and rubbing of the garment. In particular, when the belt-shaped device is relatively light, the belt-shaped device is also liable to slip by friction with the clothes. Testing under a particular set of conditions indicated that M was about 60g. The mass of the support is preferably 40 to 100g, particularly preferably 50 to 70g. The meaning of the specific conditions here is that it is foreseen that the self-mass of the belt body 10 of the belt-shaped device 1 also has a certain influence on the sliding of the belt-shaped device.

Preferably, the entire support portion 4 is detachably provided on the belt body 10 of the belt-shaped device 1. In the case where the support portion 4 includes a circuit module, the support portion 4 is preferably detachably connected to the belt body 10 by an electrical connector at this time.

Preferably, but not restrictively, the maximum profile of the support portion 4 is smaller than the profile at the position of the belt body 10 where the support portion 4 is provided, which means that the belt-shaped device 1 is seen straight from the outside, and any portion of the support portion 4 at any direction is not exposed outside the profile of the belt body 10. The arrangement is merely for aesthetic reasons, but the support portion 4 is less likely to be touched by clothes or other accidents, and the support portion 4 is likely to slide more easily than the belt body 10.

Preferably, at least 6 electrode settings 3 are provided on the belt body 10 to accommodate conventional 12 lead ECG measurements. The strip body 10 of the strip-shaped device 1 may also be long enough, for example to be wound around the back, so that at least e.g. 9 electrode settings 3 are provided on said strip body 10 to accommodate conventional 18-lead ECG measurements.

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 measuring electrodes on a belt-type device, any of a variety of chest body 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 be comfortably supported when being fixed to the chest, so that the belt-shaped device can be worn for a long time 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. Furthermore, the arrangement of the circuit module within the support portion also significantly reduces the design difficulty of the strip-shaped device.

Claims

1. A belt-shaped device adapted to be secured to a chest, comprising: a support portion provided on a surface of the band-shaped device, the surface being a side surface of the band-shaped device that faces the skin of the chest when the band-shaped device is fixed to the chest, wherein:

the support portion is disposed at a position corresponding to a depressed area in the middle of the chest when the band-shaped device is fastened to the chest;

the supporting part is provided with a circuit module, and the total mass of the circuit module and the supporting part is 40-100 g.

2. The ribbon apparatus of claim 1, wherein: the circuit module includes one or more of a battery, a wireless transmission module, or an extensible lead electrode signal interface.

3. The ribbon apparatus of claim 1, wherein: the support portion includes a housing made of a polymeric material.

4. The ribbon apparatus of claim 3, wherein: the circuit module is disposed inside the housing.

5. The ribbon apparatus of claim 3, wherein: the surface of the shell, which is in contact with the skin, is provided with fine grains, or the surface of the shell, which is in contact with the skin, is provided with a fabric material.

6. The ribbon apparatus of claim 1, wherein: the supporting part is made of an easily deformable material; alternatively, the support portion comprises a shell made of fabric, the interior of which is filled with a deformable material.

7. Strip apparatus as claimed in any preceding claim, wherein: the thickness of the support portion is gradually reduced from the side of the abdomen to the side of the neck when the band-shaped device is fixed to the chest.

8. Strip apparatus as claimed in any preceding claim, wherein: the supporting part is provided with an electrode or a sensor.

9. A bioelectrical measurement device comprising a strip device according to any one of claims 1-8.

10. The bioelectric measurement device of claim 9 wherein the bioelectric is electrocardiographic.