WO2016106647A1 - Affixable body surface electric signal collecting device and mounting method therefor - Google Patents

Affixable body surface electric signal collecting device and mounting method therefor Download PDF

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Publication number
WO2016106647A1
WO2016106647A1 PCT/CN2014/095821 CN2014095821W WO2016106647A1 WO 2016106647 A1 WO2016106647 A1 WO 2016106647A1 CN 2014095821 W CN2014095821 W CN 2014095821W WO 2016106647 A1 WO2016106647 A1 WO 2016106647A1
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WO
WIPO (PCT)
Prior art keywords
flexible
adhesive layer
substrate layer
film adhesive
flexible substrate
Prior art date
Application number
PCT/CN2014/095821
Other languages
French (fr)
Chinese (zh)
Inventor
林科
王新安
张兴
汪波
黄枫
陈啸飞
陈晨
邵海滨
李宁
郭朝阳
Original Assignee
北京大学深圳研究生院
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Publication date
Application filed by 北京大学深圳研究生院 filed Critical 北京大学深圳研究生院
Priority to PCT/CN2014/095821 priority Critical patent/WO2016106647A1/en
Publication of WO2016106647A1 publication Critical patent/WO2016106647A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof

Definitions

  • the invention relates to the field of medical instruments, in particular to an affixable body surface electrical signal collecting device and an assembling method thereof.
  • Electrocardiogram signals have been widely used in medical research, clinical examination, patient monitoring, treatment control, artificial organs and sports medicine, etc., and are a group of basic human physiological indicators. Among them, the application of electrocardiogram, brain electricity, and myoelectricity is particularly extensive, and the existing body surface electrical signal detecting device, such as an electrocardiograph, is applied. ECG, electromyograph EMG, electroencephalograph EEG, etc., doctors can make medical decisions based on measured body surface electrical signals.
  • the traditional body surface electrical signal detecting device requires the patient to statically collect the body surface electrical signal in the laboratory.
  • the collected surface electrical signal has high precision and good signal quality, it is only a single point (or a short period of time) signal data, and cannot be continuously collected in real time.
  • the collected signals are required to be real-time and continuous, and the acquisition process can be done portablely in daily life, so that the most realistic situation of the surface electrical signals can be reflected.
  • the portable body surface electrical signal detecting device merely reduces the size of the conventional monitoring device and then wears it on the body to be tested, and in addition to providing mobility, does not really improve the user's
  • the convenience of monitoring a certain physiological signal, and the large size of the device is not convenient to carry, and limits the normal life of the user.
  • the application provides an affixable body surface electrical signal collecting device and an assembling method thereof, so as to be portable to complete the collection of the electrical characteristics of the body surface to be tested, and to form a good and close ohmic contact with the body surface to be tested.
  • an affixable body surface electrical signal collecting device including:
  • the flexible electrode strip comprises a plurality of radially flexible dry electrodes and a signal output end coupled to each of the flexible dry electrodes; each flexible dry electrode is used for Collecting electrical signals of the part to be tested; the signal output end is used for outputting electrical signals collected by the flexible dry electrodes; each flexible dry electrode penetrates the flexible substrate layer and the film adhesive layer is located at the bottom of the film adhesive layer and the film adhesive layer The adhesive is adhered to the bottom of the film adhesive layer, and the adhesive is used for sticking the flexible dry electrodes and the film adhesive layer, and is also used for sticking the body surface to be tested.
  • an embodiment provides an assembly method of an attachable surface electrical signal acquisition device, including:
  • the flexible dry electrode sequentially passes through the hollow slit structure of the flexible substrate layer and the grooved structure of the film adhesive layer, and the non-surface contact surface of the flexible dry electrode is pasted to the intended pasting region of the film adhesive layer.
  • the flexible dry electrode since the flexible dry electrode is adhered to the human body to be tested through the film adhesive layer, the flexible dry electrode can form a good and close ohmic contact with the human body surface skin, which can eliminate the dry The signal deterioration effect caused by poor contact between the electrodes and the skin.
  • the affixable body surface electrical signal acquisition device is prepared by using a flexible material, so that when pasted to the user's body surface, the user's paste comfort is improved and the user experience is improved.
  • FIG. 1A and FIG. 1B are schematic diagrams showing the structure of an affixable body surface electrical signal collecting device according to an embodiment, wherein FIG. 1A is a schematic view of each layer, and FIG. 1B is a cross-sectional side view;
  • FIG. 2A and 2B are schematic views of a flexible electrode strip disclosed in the embodiment, wherein FIG. 2A is a front view and FIG. 2B is a rear view;
  • FIG. 3A and 3B are schematic views of another flexible electrode strip disclosed in the embodiment, wherein FIG. 3A is a front view and FIG. 3B is a rear view;
  • FIG. 4 is a schematic structural view of a flexible dry electrode disclosed in the embodiment.
  • FIG. 5A and 5B are schematic views showing a structure of a flexible substrate layer, wherein FIG. 5A is a front view and FIG. 5B is a side view;
  • FIG. 6A, FIG. 6B and FIG. 6C are schematic diagrams showing the form of the electric signal collecting device disclosed in the embodiment after being attached to the body surface, wherein FIG. 6A is a schematic view of the shape of the flexible electrode strip under normal skin condition, and FIG. 6B is a view of the skin contraction. Schematic diagram of the shape of the flexible electrode strip, FIG. 6C is a schematic view of the shape of the flexible electrode strip in the case of skin stretching;
  • FIG. 7A and 7B are schematic views of a film adhesive layer disclosed in the embodiment, wherein FIG. 7A is a front view, and FIG. 7B is a rear view;
  • Figure 8 is a schematic view showing the contact state of the flexible dry electrode with the skin disclosed in the embodiment.
  • FIG. 9 is a schematic diagram of a bonding form of an electrical signal collecting device and a skin surface of the body disclosed in the embodiment.
  • Figure 10 is a schematic block diagram showing a structure of a circuit unit disclosed in the embodiment.
  • FIG. 11A and FIG. 11B are schematic views of a casing disclosed in the embodiment, wherein FIG. 11A is a front elevational view, and FIG. 11B is a side cross-sectional view;
  • FIGS. 12A, 12B and 12C are schematic views of another housing disclosed in the embodiment, wherein Fig. 12A is a front view, 12B is a side cross-sectional view, and Fig. 12C is a side cross-sectional view after being placed in the circuit unit.
  • an attachable body surface electrical signal collecting device 100 disclosed in this embodiment includes: a flexible electrode strip 101, a flexible substrate layer 103 and a film adhesive layer arranged in order from top to bottom. 104, wherein
  • the flexible electrode strip 101 includes a plurality of radial flexible dry electrodes 1013 and signal output ends coupled to the respective flexible dry electrodes 1013.
  • Each flexible dry electrode 1013 is used to collect electrical signals of the body to be tested, and the signal output ends are used for outputting each. The electrical signal collected by the flexible dry electrode 1013.
  • Each of the flexible dry electrodes 1013 penetrates the flexible substrate layer 103 and the film bonding layer 104 is placed on the bottom of the film bonding layer 104 to adhere to the film bonding layer 104.
  • the flexible substrate layer 103 is used to support and protect the flexible electrode strip 101.
  • An adhesive 1044 is attached to the bottom of the film adhesive layer 104.
  • the adhesive 1044 is used for adhering the flexible dry electrodes 1013 and the film adhesive layer 104, and is also used for sticking the body surface to be tested, thereby accommodating the electrical signal collecting device 100 and the human body.
  • the surface of the test site is tightly bonded.
  • each of the flexible dry electrodes 1013 can be inserted into the bottom of the film adhesive layer 104 through a slit or a through hole provided in the flexible substrate layer 103 and the film adhesive layer 104, and then pasted on the film.
  • the bottom of layer 104 is used for adhering the flexible dry electrodes 1013 and the film adhesive layer 104, and is also used for sticking the body surface to be tested, thereby accommodating the electrical signal collecting device 100 and the human body.
  • the surface of the test site is tightly bonded.
  • each of the flexible dry electrodes 1013 can be inserted into the bottom of the film adhesive layer 104 through a slit or a through hole provided in the flexible substrate
  • the electrical signal acquisition device 100 can also include a circuit unit 102 coupled to the signal output for processing the electrical signal output by the signal output.
  • the electrical signal acquisition device 100 may further include: a casing 105 housing 105 for wrapping the flexible electrode strip 101, the flexible substrate layer 103, and the film adhesive layer 104 from the upper portion of the flexible electrode strip 101, or The casing 105 also wraps around the circuit unit 102.
  • the casing 105 is used to achieve waterproof, dustproof, and/or anti-collision of the internal components of the electrical signal acquisition device 100.
  • Each of the flexible dry electrodes 1013 is radially outward with the signal output end as a plane center.
  • Each of the flexible dry electrodes 1013 may be distributed according to a preset rule, which may be determined according to different detection parts of the body surface, such as: chest lead, single lead, three lead, five lead, nine lead Linked or simulated lead, etc., these are distributed in various parts of the body such as hands, feet, chest, etc., and then simulated as a point far away from the heart, shortened to the heart to collect.
  • the three flexible dry electrodes 1013 are integrated on the flexible electrode strip 101 as an example.
  • each flexible dry electrode 1013 on the flexible electrode strip 101 is connected to the signal output end. The angle between them is 180°, the length is the same, and at the same time, the connection between the third flexible single electrode 1013 and the connector structure 1011 is 90°.
  • each flexible dry electrode 1013 can be coupled to a signal output via an electrical connection 1012.
  • the flexible electrode strip includes a first connector structure 1011a and a second connector structure 1011b, with the first connector structure 1011a being a planar center extending toward the radiation.
  • Two paths, the end of the path is a first flexible dry electrode 1013a and a second flexible dry electrode 1013b, and a third flexible dry electrode 1013c; with the second connector structure 1011b as a plane center, two paths are outwardly radiated, the end of the path
  • the fourth flexible dry electrode 1013d, the fifth flexible dry electrode 1013e, and the sixth flexible dry electrode 1013f are outwardly radiated, the end of the path.
  • the second flexible dry electrode 1013b and the third flexible dry electrode 1013c share one path
  • the fourth flexible dry electrode 1013d and the fifth flexible dry electrode 1013e share one path.
  • the first flexible dry electrode 1013a, the second flexible dry electrode 1013b, and the third flexible dry electrode 1013c are connected to the first connector structure 1011a by an electrical connection line 1012 on the extending path thereof
  • the dry electrode 1013e and the sixth flexible dry electrode 1013f are connected to the second connector structure 1011b by an electrical connection line 1012 on an extending path thereof.
  • the flexible electrode strip of the embodiment can be used for attaching to the left front chest of the human body, and can be used for collecting the chest lead ECG signal of the human body surface. In other embodiments, the flexible electrode strip may also employ other flexible dry electrode distributions.
  • each flexible dry electrode 1013 is a microneedle array 10131 that is only one side that can be in contact with a human body surface, and the contact surface is made of a metal conductive material (eg, gold, copper), such as As shown in FIG. 4, the microneedle array structure can pierce the stratum corneum of the human body surface when it comes into contact with the body surface to be tested, so that the electrical characteristics of the part can be better collected.
  • the microneedle array 10131 is coated with a layer of silver or silver chloride material 10132.
  • the flexible electrode strip 101 includes a connector structure 1011 with a signal output end secured to the connector structure 1011 through which the flexible electrode strip 101 is mechanically coupled to the flexible substrate layer 103.
  • the connector structure 1011, each of the flexible dry electrodes 1013, and the electrical connection lines 1012 are all fabricated based on a flexible printed circuit board substrate.
  • the flexible dry electrode 1013 and the electrical connection line 1012 are respectively fabricated on both sides of the flexible printed circuit board substrate and electrically connected through the through holes 1015.
  • the shape profile of the flexible substrate layer 103 is such that the outer contour of the shape of the flexible electrode strip 101 is enlarged so that the flexible substrate layer 103 can completely cover the flexible electrode strip 101.
  • the shape profile of the flexible substrate layer 103 may also be equal to or slightly smaller than the shape profile of the flexible electrode strip 101.
  • the flexible substrate layer 103 should be made of a material having stretch elasticity or also water absorption and gas permeability, such as spunlace nonwoven fabric, non-woven fabric, foam, polyethylene (PE). ), polyethylene terephthalate (PET).
  • a mechanical link 1031 is also provided on the contact surface of the flexible substrate layer 103 with the connector structure 1011 of the flexible electrode strip 101, by which the mechanical link 1031 can form a mechanical link with the connector structure 1011, thereby fixing the connector.
  • the structure 1011, and the corresponding positions of the flexible dry electrode 1013 and the electrical connection line 1012 and the flexible substrate layer 103 are relatively fixed without mechanical linkage, and are not horizontally displaced or rotated.
  • a hollow slit structure 1032 is provided on the flexible substrate layer 103 at a position corresponding to each of the flexible dry electrodes 1013, and the hollow slit structure 1032 is used to pass through the corresponding flexible dry electrode 1013, thereby placing the flexible dry electrodes 1013 in flexibility.
  • the distance between the hollowed-slit structure 1032 to the mechanical connection point of the connector structure 1011 and the flexible substrate layer 103 is less than the distance of its corresponding flexible dry electrode 1013 to the mechanical connection point.
  • the electrical connection line 1012 of the flexible electrode strip 101 should be bent and suspended on the flexible substrate surface 103, as shown in FIGS.
  • the shape of the film adhesive layer 104 is such that the outer contour of the shape of the flexible substrate layer 103 is enlarged so that the flexible substrate layer 103 can completely cover the flexible substrate layer 103.
  • the shape profile of the flexible substrate layer 103 may also be equal to or slightly smaller than the shape profile of the flexible substrate layer 103.
  • the film adhesive layer 104 should be made of a material having stretch elasticity or also water absorption and gas permeability, such as polyethylene (PE) or polyethylene terephthalate (PET). .
  • the film adhesive layer 104 The flexible substrate layer 103 can be attached and fixed by gluing.
  • the adhesive layer on the film adhesive layer 104 and the flexible substrate layer 103 should be attached with an adhesive so that the film adhesive layer 104 and the flexible substrate layer 103 are closely adhered.
  • a grooved structure 1041 is provided on the film adhesive layer 104 at a position corresponding to each of the hollow slit structures 1032, and the grooved structure 1041 is used to pass through the flexible dry electrode 1013 corresponding to the hollow slit structure 1032.
  • the distance from the slotted structure 1041 to the mechanical joint of the connector structure 1011 to the flexible substrate layer 103 is less than the distance of its corresponding hollow slotted structure 1032 to the mechanical joint.
  • the slotted structure 1041 allows the corresponding flexible dry electrode 1013 to pass through, and the back surface of the flexible dry electrode 1013 can be adhered to the back surface of the film adhesive layer 104 after being bonded to the back surface of the film adhesive layer 104.
  • the flexible dry electrode 1013 can form a good and tight ohmic contact with the skin of the human body surface, and then, the contact with the skin due to the flexible dry electrode 1013 can be eliminated.
  • the adhesive 1044 attached to the bottom of the film adhesive layer 104 (the side in contact with the body surface) is distributed at least in the intended adhesion region 1046 of each flexible dry electrode 1013, or is also distributed over the limited epitaxy of each flexible dry electrode 1013. Area 1045. Therefore, when the electrical signal collecting device 100 is attached to the body surface, as shown in FIG. 9, when the skin of the human body is protruded or recessed due to the movement of the human body, the collecting device 100 can ensure the position of the dry electrode and the skin of the body surface.
  • the adaptive adjustment of the matching shape and the relative position of the collection device 100 and the skin of the body surface can ensure the quality of the electrical signal of the human body surface collected by the collection device 100, and also improve the collection.
  • the paste comfort of the device 100 can ensure the quality of the electrical signal of the human body surface collected by the collection device 100, and also improve the collection.
  • the adhesive 1044 should be made of a material that is highly viscous, conformable, and less susceptible to skin sensitivity, such as acrylates, synthetic rubbers.
  • the circuit unit 102 may include: a signal conditioning circuit 1021 for amplifying, filtering, and digital-to-analoging signals from the flexible dry electrode 1013 in the flexible electrode strip 102; for data processing, data A central processing circuit 1022 for forwarding, control, a storage circuit 1023 for data temporary storage, a communication circuit 1024 for data transmission, and a power management circuit 1025 for power supply.
  • the circuit unit 102 is encapsulated in the hermetic casing 1026, only the signal connector 1027 is exposed to the hermetic casing, and the signal connector 1027 is capable of forming an electrical connection with the signal output terminal of the flexible electrode strip 101.
  • the shape contour of the casing 105 is consistent with the shape contour of the film bonding layer 104, and the casing 105 is fixedly connected to the film bonding layer 104. In a specific embodiment, it may be fixed by the adhesive and the film bonding layer 104. connection.
  • the material of the casing 105 is pressure-resistant. In a preferred embodiment, the material of the casing 105 also has a material that is stretchable, waterproof, dustproof, and resistant to weak acid and alkali corrosion, such as silica gel.
  • the film adhesive layer 104 when the shape profile of the film adhesive layer 104 is slightly smaller than the shape profile of the flexible substrate layer 103, that is, the shape of the film adhesive layer 104 is a limited retraction of the shape profile of the flexible substrate layer 103, the film is pasted.
  • the shape contour of the layer 104 should be larger than the shape profile of the flexible electrode strip 101, in which case the housing 105 should be fixed, for example, bonded to the flexible substrate layer 103.
  • the casing 105 is gradually raised from the edge toward the center, and a cavity 1052 can be formed therein and subjected to a certain force impact.
  • the circuit unit 102 is disposed in the cavity 1052.
  • a mechanical link snap structure 1051 or other mechanical structure capable of holding the circuit unit 102 is disposed in the middle of the casing 105, and the circuit unit 102 can be placed in the air through the snap structure 1051.
  • the circuit unit 102 is non-detachably secured within the cavity 1052; in another embodiment, the circuit unit 102 can also be removably placed within the cavity 1052.
  • the sealing sleeve 1026 of the circuit unit 102 has a mechanical link buckle 10261 on its surface, which can form a mechanical link with the mechanical link buckle 1051 in the casing 105.
  • a mechanical link snap structure 1051 is formed in the middle of the casing 105, and the circuit unit 102 can be inserted into the casing 105 to mechanically link the mechanical link buckle structure 10261 on the surface of the sealed casing 1026 of the circuit unit 102, so that the circuit unit 102 is The casing 105 is completely wrapped and cannot be removed from the entire device.
  • the top of the casing 105 has a window opening structure 1053 through which the cavity 1052 communicates, and the window shape contour conforms to the shape of the sealing casing 1026 of the circuit unit 102.
  • the circuit unit 102 can be embedded in the casing 105 to mechanically link the mechanical link buckle structure 10261 on the surface of the sealed casing 1026 of the circuit unit 102, so that the circuit unit 102 is free of gaps between the casings 105 and can be from the entire device. Disassembled.
  • An advantage of the detachable connection of the circuit unit 102 to the housing 105 is that the circuit unit 102 can be used multiple times, while the remaining assembled components of the electrical signal acquisition device 100 as a single unit are disposable.
  • the electrical signal acquisition device 100 when used as a reproducible medical device, components that are in contact with the body surface, such as the flexible electrode strip 101, the flexible substrate layer 103, and the film adhesive layer 104, can be used as a single-use single-use consumable.
  • the circuit unit 102 in contact with the body surface can be used as a common component for multiple use by multiple people. In this way, when the electrical signal collection device provided by the embodiment is used to collect the electrical signals of the human body surface, the cost and resource consumption can be minimized under the premise of ensuring safety and sanitation.
  • the embodiment also discloses an assembly method of the affixable body surface electrical signal collecting device, which comprises the following steps:
  • the flexible dry electrode 1013 of the flexible electrode strip 101 is sequentially passed through the hollow slit structure 1032 of the flexible substrate layer 103 and the slotted structure 1041 of the film adhesive layer 104, and the non-human body of the flexible dry electrode 1013 The surface contact surface is pasted to the intended adhesion area of the film adhesive layer 104.
  • the electrical signal collecting device further includes the casing 105
  • the following steps are further included after the penetrating step:
  • the edge of the casing 105 is bonded to the film adhesive layer 104;
  • the edge of the casing 105 is bonded to the flexible substrate layer 103 when the shape profile of the film-attachment layer 104 is slightly less than or equal to the shape profile of the flexible substrate layer 103.
  • the electrical signal acquisition device further includes the circuit unit 102, and the circuit unit 102 is non-detachably disposed in the casing 105, the circuit unit 102 should be first fixed in the cavity 1052 of the casing 105. Then, the edge of the casing 105 is bonded to the film adhesive layer 104 or the flexible substrate layer 103.
  • other components of the flexible attachable surface electrical signal acquisition device can be deducted and assembled based on the shape profile of the flexible electrode strip 101.
  • the affixable body surface electrical signal collecting device disclosed in this embodiment can be used for collecting an electrocardiogram signal, an electromyogram signal or a skin electrical impedance signal of a human body surface, and has the following advantages:
  • the flexible dry electrode of the affixable body surface electrical signal collecting device disclosed in this embodiment can form a good and tight ohmic contact with the skin of the human body surface, that is, the signal deterioration effect caused by poor contact between the dry electrode and the skin can be eliminated.
  • the collection quality of the body surface electrical signal is improved, and the conductive glue/liquid for improving the contact quality in the commercial silver chloride wet electrode is also avoided, thereby improving the paste comfort of the device of the embodiment.
  • the collection process of the electrocardiogram signal or the electromyogram signal or the skin electrical impedance signal does not require a lead wire, thereby improving the convenience and comfort of the acquisition process; There is no lead wire in the conduction process of the surface electrical signal.
  • the collected signal will not have the noise and interference signals introduced by the lead wire in the traditional device, which improves the signal acquisition quality.
  • the electric signal collecting device since the electric signal collecting device is manufactured and assembled according to the above embodiment, the electric signal collecting device does not need to carry the volume device, and can be directly attached to the chest, the arm, the leg, etc. like the wound patch, and needs to collect the electrocardiogram signal or the myoelectricity. Signal or skin electrical impedance signal of the body surface to be tested, and the acquisition process does not affect the wearer's normal living activities, suitable for long-term, continuous collection of ECG signals or EMG signals or skin electrical impedance signals The collected signal data is more valuable. For the user, the process is comfortable and very suitable for wearing for more than 72 hours.

Abstract

An affixable body surface electric signal collecting device comprising a flexible electrode band (101), a flexible substrate layer (103), and an adhesive film layer (104) arranged in a downward sequence. The flexible electrode band (101) comprises and integrates multiple radially-shaped flexible dry electrodes (1013). The flexible dry electrodes (1013) run through the flexible substrate layer (103) and the adhesive film layer (104) to be affixed with the adhesive film layer (104) at the bottom of the adhesive film layer (104). An adhesive agent (1044) is attached to the bottom of the adhesive film layer (104), used for affixing the flexible dry electrodes (1013) and the adhesive film layer (104), and used for affixing to a to-be-tested part on the body surface of a human body. Also provided is a mounting method for the device. By affixing the flexible dry electrodes (1013) to a to-be-tested area of the human body via the adhesive film layer (104), the flexible dry electrodes (1013) is allowed to form a great and tight ohmic contact with the skin on the body surface of the human body, thus eliminating signal degradation effects brought forth by poor contact between the dry electrodes (1013) and the skin.

Description

可粘贴体表电信号采集设备及其装配方法  Attachable body surface electric signal collecting device and assembling method thereof 技术领域Technical field
本发明涉及医疗器械领域,具体涉及一种可粘贴体表电信号采集设备及其装配方法。 The invention relates to the field of medical instruments, in particular to an affixable body surface electrical signal collecting device and an assembling method thereof.
背景技术Background technique
体表电信号已经广泛应用于医学研究、临床检查、病人监护、治疗控制以及人工器官和运动医学等领域,是一类基础性人体生理指标。其中,对于心电、脑电、肌电的应用尤其广泛,应用现有的体表电信号检测装置,例如心电图仪 ECG、肌电图仪 EMG、脑电图仪 EEG 等,医生可以根据测量的体表电信号,做出医学决策。Surface electrical signals have been widely used in medical research, clinical examination, patient monitoring, treatment control, artificial organs and sports medicine, etc., and are a group of basic human physiological indicators. Among them, the application of electrocardiogram, brain electricity, and myoelectricity is particularly extensive, and the existing body surface electrical signal detecting device, such as an electrocardiograph, is applied. ECG, electromyograph EMG, electroencephalograph EEG, etc., doctors can make medical decisions based on measured body surface electrical signals.
传统的体表电信号检测设备需病人在检验室里,静态地采集体表电信号。所采集到的体表电信号虽然精度高、信号质量好,但仅为单点(或短暂一段时间内)信号数据,无法连续实时采集。然而,在临床监测、运动医学控制等领域,要求所采集的信号实时、连续,且采集过程可在日常生活过程中便携地完成,这样,才能反映体表电信号最真实的情况。The traditional body surface electrical signal detecting device requires the patient to statically collect the body surface electrical signal in the laboratory. Although the collected surface electrical signal has high precision and good signal quality, it is only a single point (or a short period of time) signal data, and cannot be continuously collected in real time. However, in the fields of clinical monitoring, sports medicine control, etc., the collected signals are required to be real-time and continuous, and the acquisition process can be done portablely in daily life, so that the most realistic situation of the surface electrical signals can be reflected.
目前,也有一些体表电信号检测设备将其体积小型化。然而,这种便携式的体表电信号检测装置仅仅是将传统的监测设备体积缩小,然后再将其佩戴于待测人体身上,除可提供可移动性之外,并未真正的提高使用者的某种生理信号监测的方便性,而且设备体积较大,携带并不方便,会对使用者的正常生活有所限制。At present, there are also some surface electrical signal detecting devices that miniaturize their size. However, the portable body surface electrical signal detecting device merely reduces the size of the conventional monitoring device and then wears it on the body to be tested, and in addition to providing mobility, does not really improve the user's The convenience of monitoring a certain physiological signal, and the large size of the device, is not convenient to carry, and limits the normal life of the user.
发明内容Summary of the invention
本申请提供一种可粘贴体表电信号采集设备及其装配方法,以便于便携地完成待测人体体表电特性的采集,并能够与待测人体体表形成良好、紧密的欧姆接触。The application provides an affixable body surface electrical signal collecting device and an assembling method thereof, so as to be portable to complete the collection of the electrical characteristics of the body surface to be tested, and to form a good and close ohmic contact with the body surface to be tested.
依据本发明的第一方面,一种实施方式提供一种可粘贴体表电信号采集设备,包括:According to a first aspect of the present invention, an embodiment provides an affixable body surface electrical signal collecting device, including:
自上至下依次布置的柔性电极带、柔性基材层和薄膜粘贴层;柔性电极带包括集成多个放射状的柔性干电极以及与各柔性干电极耦合的信号输出端;各柔性干电极用于采集人体待测部位的电信号;信号输出端用于输出各柔性干电极所采集的电信号;各柔性干电极穿透于柔性基材层和薄膜粘贴层位于薄膜粘贴层的底部与薄膜粘贴层贴合;薄膜粘贴层的底部附着有胶粘剂,胶粘剂用于粘贴住各柔性干电极和薄膜粘贴层,还用于粘贴住人体体表待测部位。a flexible electrode strip, a flexible substrate layer and a film adhesive layer arranged in order from top to bottom; the flexible electrode strip comprises a plurality of radially flexible dry electrodes and a signal output end coupled to each of the flexible dry electrodes; each flexible dry electrode is used for Collecting electrical signals of the part to be tested; the signal output end is used for outputting electrical signals collected by the flexible dry electrodes; each flexible dry electrode penetrates the flexible substrate layer and the film adhesive layer is located at the bottom of the film adhesive layer and the film adhesive layer The adhesive is adhered to the bottom of the film adhesive layer, and the adhesive is used for sticking the flexible dry electrodes and the film adhesive layer, and is also used for sticking the body surface to be tested.
依据本发明的第二方面,一种实施方式提供一种可粘贴体表电信号采集设备的装配方法,包括:According to a second aspect of the present invention, an embodiment provides an assembly method of an attachable surface electrical signal acquisition device, including:
粘贴步骤,将柔性基材层与薄膜粘贴层对迎面相粘合;机械固定步骤,将柔性电极带的连接器结构与柔性基材层相应位置机械链接并固定;穿透步骤,将柔性电极带的柔性干电极依次穿过柔性基材层的镂空细缝结构和薄膜粘贴层的开槽结构,并将柔性干电极的非与人体体表接触面粘贴至薄膜粘贴层的拟粘贴区域。a step of bonding, bonding the flexible substrate layer and the film adhesive layer to the face; mechanically fixing step, mechanically linking and fixing the connector structure of the flexible electrode tape and the corresponding position of the flexible substrate layer; The flexible dry electrode sequentially passes through the hollow slit structure of the flexible substrate layer and the grooved structure of the film adhesive layer, and the non-surface contact surface of the flexible dry electrode is pasted to the intended pasting region of the film adhesive layer.
依据本发明的可粘贴体表电信号采集设备,由于通过薄膜粘贴层将柔性干电极粘贴于人体待测区域,柔性干电极可与人体体表皮肤形成良好、紧密的欧姆接触,能消除由于干电极与皮肤接触不好而带来的信号恶化效果。可粘贴体表电信号采集设备采用柔性材质制备,使得在粘贴至用户体表时,提高了用户的粘贴舒适度,改善用户体验。According to the affixable body surface electrical signal collecting device of the present invention, since the flexible dry electrode is adhered to the human body to be tested through the film adhesive layer, the flexible dry electrode can form a good and close ohmic contact with the human body surface skin, which can eliminate the dry The signal deterioration effect caused by poor contact between the electrodes and the skin. The affixable body surface electrical signal acquisition device is prepared by using a flexible material, so that when pasted to the user's body surface, the user's paste comfort is improved and the user experience is improved.
附图说明DRAWINGS
图1A和图1B是实施例公开的一种可粘贴体表电信号采集设备结构示意图,其中,图1A为各层分视示意图,图1B为截面侧视示意图;1A and FIG. 1B are schematic diagrams showing the structure of an affixable body surface electrical signal collecting device according to an embodiment, wherein FIG. 1A is a schematic view of each layer, and FIG. 1B is a cross-sectional side view;
图2A和图2B是实施例公开的一种柔性电极带示意图,其中,图2A是正视示意图,图2B是背视示意图;2A and 2B are schematic views of a flexible electrode strip disclosed in the embodiment, wherein FIG. 2A is a front view and FIG. 2B is a rear view;
图3A和图3B是实施例公开的另一种柔性电极带示意图,其中,图3A是正视示意图,图3B是背视示意图;3A and 3B are schematic views of another flexible electrode strip disclosed in the embodiment, wherein FIG. 3A is a front view and FIG. 3B is a rear view;
图4是实施例公开的柔性干电极的一种结构示意图;4 is a schematic structural view of a flexible dry electrode disclosed in the embodiment;
图5A和图5B实施例公开的柔性基材层的一种结构示意图,其中,图5A是正视示意图,图5B是侧视示意图;5A and 5B are schematic views showing a structure of a flexible substrate layer, wherein FIG. 5A is a front view and FIG. 5B is a side view;
图6A、图6B和图6C是实施例公开的电信号采集设备粘贴于人体体表后的形态示意图,其中,图6A是皮肤正常情况下柔性电极带形态的示意图,图6B是皮肤收缩情况下柔性电极带形态的示意图,图6C皮肤拉伸情况柔性电极带形态的下示意图;6A, FIG. 6B and FIG. 6C are schematic diagrams showing the form of the electric signal collecting device disclosed in the embodiment after being attached to the body surface, wherein FIG. 6A is a schematic view of the shape of the flexible electrode strip under normal skin condition, and FIG. 6B is a view of the skin contraction. Schematic diagram of the shape of the flexible electrode strip, FIG. 6C is a schematic view of the shape of the flexible electrode strip in the case of skin stretching;
图7A和图7B是实施例公开的一种薄膜粘贴层示意图,其中,图7A是正视示意图,图7B是背视示意图;7A and 7B are schematic views of a film adhesive layer disclosed in the embodiment, wherein FIG. 7A is a front view, and FIG. 7B is a rear view;
图8是实施例公开的柔性干电极与皮肤接触形态的一种示意图;Figure 8 is a schematic view showing the contact state of the flexible dry electrode with the skin disclosed in the embodiment;
图9是实施例公开的电信号采集设备与体表皮肤的贴合形态的一种示意图;9 is a schematic diagram of a bonding form of an electrical signal collecting device and a skin surface of the body disclosed in the embodiment;
图10是实施例公开的电路单元的一种结构示意框图;Figure 10 is a schematic block diagram showing a structure of a circuit unit disclosed in the embodiment;
图11A和图11B是实施例公开的一种机壳示意图,其中,图11A是正视示意图,图11B是侧向截面示意图;11A and FIG. 11B are schematic views of a casing disclosed in the embodiment, wherein FIG. 11A is a front elevational view, and FIG. 11B is a side cross-sectional view;
图12A、12B和图12C是实施例公开的另一种机壳示意图,其中,图12A是正视示意图,12B是侧向截面示意图;图12C是置入电路单元后的侧向截面示意图。12A, 12B and 12C are schematic views of another housing disclosed in the embodiment, wherein Fig. 12A is a front view, 12B is a side cross-sectional view, and Fig. 12C is a side cross-sectional view after being placed in the circuit unit.
具体实施方式detailed description
请参考图1A、图1B和图2A,本实施例公开的一种可粘贴体表电信号采集设备100包括:自上至下依次布置的柔性电极带101、柔性基材层103和薄膜粘贴层104,其中,Referring to FIG. 1A, FIG. 1B and FIG. 2A, an attachable body surface electrical signal collecting device 100 disclosed in this embodiment includes: a flexible electrode strip 101, a flexible substrate layer 103 and a film adhesive layer arranged in order from top to bottom. 104, wherein
柔性电极带101包括集成多个放射状的柔性干电极1013以及与各柔性干电极1013耦合的信号输出端,各柔性干电极1013用于采集人体待测部位的电信号,信号输出端用于输出各柔性干电极1013所采集的电信号。The flexible electrode strip 101 includes a plurality of radial flexible dry electrodes 1013 and signal output ends coupled to the respective flexible dry electrodes 1013. Each flexible dry electrode 1013 is used to collect electrical signals of the body to be tested, and the signal output ends are used for outputting each. The electrical signal collected by the flexible dry electrode 1013.
各柔性干电极1013穿透于柔性基材层103和薄膜粘贴层104位于薄膜粘贴层104的底部与薄膜粘贴层104贴合。Each of the flexible dry electrodes 1013 penetrates the flexible substrate layer 103 and the film bonding layer 104 is placed on the bottom of the film bonding layer 104 to adhere to the film bonding layer 104.
柔性基材层103用于支撑和保护柔性电极带101。The flexible substrate layer 103 is used to support and protect the flexible electrode strip 101.
薄膜粘贴层104的底部附着有胶粘剂1044,胶粘剂1044用于粘贴住各柔性干电极1013和薄膜粘贴层104,还用于粘贴住人体体表待测部位,从而将电信号采集设备100与人体待测部位体表紧密粘合。在具体实施例中,各柔性干电极1013可以通过设置在柔性基材层103和薄膜粘贴层104上的细缝或通孔穿入至薄膜粘贴层104的底部并贴合,继而粘贴在薄膜粘贴层104的底部。An adhesive 1044 is attached to the bottom of the film adhesive layer 104. The adhesive 1044 is used for adhering the flexible dry electrodes 1013 and the film adhesive layer 104, and is also used for sticking the body surface to be tested, thereby accommodating the electrical signal collecting device 100 and the human body. The surface of the test site is tightly bonded. In a specific embodiment, each of the flexible dry electrodes 1013 can be inserted into the bottom of the film adhesive layer 104 through a slit or a through hole provided in the flexible substrate layer 103 and the film adhesive layer 104, and then pasted on the film. The bottom of layer 104.
电信号采集设备100还可以包括:电路单元102,电路单元102耦合至信号输出端,用于处理信号输出端输出的电信号。The electrical signal acquisition device 100 can also include a circuit unit 102 coupled to the signal output for processing the electrical signal output by the signal output.
在优选的实施例中,电信号采集设备100还可以包括:机壳105机壳105,用于从柔性电极带101上部包裹住柔性电极带101、柔性基材层103和薄膜粘贴层104,或者机壳105还包裹住电路单元102。机壳105用于实现电信号采集设备100内部器件的防水、防尘和/或防撞击。In a preferred embodiment, the electrical signal acquisition device 100 may further include: a casing 105 housing 105 for wrapping the flexible electrode strip 101, the flexible substrate layer 103, and the film adhesive layer 104 from the upper portion of the flexible electrode strip 101, or The casing 105 also wraps around the circuit unit 102. The casing 105 is used to achieve waterproof, dustproof, and/or anti-collision of the internal components of the electrical signal acquisition device 100.
请参考图2A、图2B和图2C,为本实施例柔性电极带101的一种结构示意图,各柔性干电极1013以信号输出端为平面中心向外呈放射状。各柔性干电极1013可以基于预设的规则进行分布,该预设规则可以依据人体体表的不同检测部位而定,譬如:胸导联、单导联、三导联、五导联、九导联或者模拟导联等,这些都是分布在身体各个部位如手、足、胸等,再如模拟导为将离心脏很远的点,缩短到心脏周围进行采集。以柔性电极带101上集成三个柔性干电极1013为例进行说明,一种分布方式如图2A和图2B所示,柔性电极带101上的其中两个柔性干电极1013与信号输出端连线间的夹角为180°,长度相同,同时,与第三柔性单电极1013与连接器结构1011的连线间为90°。在具体实施例中,各柔性干电极1013可以通过电气连接线1012耦合至信号输出端。Referring to FIG. 2A, FIG. 2B and FIG. 2C, a schematic structural view of the flexible electrode strip 101 of the present embodiment is illustrated. Each of the flexible dry electrodes 1013 is radially outward with the signal output end as a plane center. Each of the flexible dry electrodes 1013 may be distributed according to a preset rule, which may be determined according to different detection parts of the body surface, such as: chest lead, single lead, three lead, five lead, nine lead Linked or simulated lead, etc., these are distributed in various parts of the body such as hands, feet, chest, etc., and then simulated as a point far away from the heart, shortened to the heart to collect. The three flexible dry electrodes 1013 are integrated on the flexible electrode strip 101 as an example. One distribution mode is shown in FIG. 2A and FIG. 2B. Two flexible dry electrodes 1013 on the flexible electrode strip 101 are connected to the signal output end. The angle between them is 180°, the length is the same, and at the same time, the connection between the third flexible single electrode 1013 and the connector structure 1011 is 90°. In a particular embodiment, each flexible dry electrode 1013 can be coupled to a signal output via an electrical connection 1012.
在另一种具体实施例中,请参考图3A和图3B,柔性电极带包括第一连接器结构1011a和第二连接器结构1011b,以第一连接器结构1011a为平面中心,向放射延伸出两条路径,路径末端为第一柔性干电极1013a和第二柔性干电极1013b、第三柔性干电极1013c;以第二连接器结构1011b为平面中心,向外放射延伸出两条路径,路径末端为第四柔性干电极1013d、第五柔性干电极1013e和第六柔性干电极1013f。其中,第二柔性干电极1013b和第三柔性干电极1013c共享一条路径,第四柔性干电极1013d和第五柔性干电极1013e共享一条路径。第一柔性干电极1013a、第二柔性干电极1013b和第三柔性干电极1013c在其延伸路径上以电气连接线1012与第一连接器结构1011a相连接,第四柔性干电极1013d、第五柔性干电极1013e和第六柔性干电极1013f在其延伸路径上以电气连接线1012与第二连接器结构1011b相连接。本实施例的柔性电极带可用于贴至人体左前胸下册,能够用于采集人体体表的胸导联心电信号。在其它实施例中,柔性电极带还可以采用其它的柔性干电极分布方式。In another specific embodiment, referring to FIG. 3A and FIG. 3B, the flexible electrode strip includes a first connector structure 1011a and a second connector structure 1011b, with the first connector structure 1011a being a planar center extending toward the radiation. Two paths, the end of the path is a first flexible dry electrode 1013a and a second flexible dry electrode 1013b, and a third flexible dry electrode 1013c; with the second connector structure 1011b as a plane center, two paths are outwardly radiated, the end of the path The fourth flexible dry electrode 1013d, the fifth flexible dry electrode 1013e, and the sixth flexible dry electrode 1013f. The second flexible dry electrode 1013b and the third flexible dry electrode 1013c share one path, and the fourth flexible dry electrode 1013d and the fifth flexible dry electrode 1013e share one path. The first flexible dry electrode 1013a, the second flexible dry electrode 1013b, and the third flexible dry electrode 1013c are connected to the first connector structure 1011a by an electrical connection line 1012 on the extending path thereof, and the fourth flexible dry electrode 1013d, the fifth flexible The dry electrode 1013e and the sixth flexible dry electrode 1013f are connected to the second connector structure 1011b by an electrical connection line 1012 on an extending path thereof. The flexible electrode strip of the embodiment can be used for attaching to the left front chest of the human body, and can be used for collecting the chest lead ECG signal of the human body surface. In other embodiments, the flexible electrode strip may also employ other flexible dry electrode distributions.
在优选的实施例中,各柔性干电极1013为一种仅单面可与人体体表接触,且接触面为以金属导电材料(如:金、铜)制成的微针列阵10131,如图4所示,采用这种微针列阵结构,在与人体体表待测部位接触时,能够刺破该部位人体体表的角质层,从而能够更好地采集该部位的电特性。在优选的实施例中,微针列阵10131表面覆有银或氯化银材料层10132。In a preferred embodiment, each flexible dry electrode 1013 is a microneedle array 10131 that is only one side that can be in contact with a human body surface, and the contact surface is made of a metal conductive material (eg, gold, copper), such as As shown in FIG. 4, the microneedle array structure can pierce the stratum corneum of the human body surface when it comes into contact with the body surface to be tested, so that the electrical characteristics of the part can be better collected. In a preferred embodiment, the microneedle array 10131 is coated with a layer of silver or silver chloride material 10132.
在优选的实施例中,柔性电极带101包括连接器结构1011,信号输出端固定在连接器结构1011上,柔性电极带101通过该连接器结构1011与柔性基材层103机械连接。In a preferred embodiment, the flexible electrode strip 101 includes a connector structure 1011 with a signal output end secured to the connector structure 1011 through which the flexible electrode strip 101 is mechanically coupled to the flexible substrate layer 103.
在具体实施例中,连接器结构1011、各柔性干电极1013和电气连接线1012均基于挠性印制电路板基材制造。柔性干电极1013和电气连接线1012分别制造于挠性印制电路板基材两面,并通过通孔1015进行电气连接。In a particular embodiment, the connector structure 1011, each of the flexible dry electrodes 1013, and the electrical connection lines 1012 are all fabricated based on a flexible printed circuit board substrate. The flexible dry electrode 1013 and the electrical connection line 1012 are respectively fabricated on both sides of the flexible printed circuit board substrate and electrically connected through the through holes 1015.
请参考图5A和图5B,柔性基材层103的形状轮廓为柔性电极带101的形状轮廓外沿扩大,以使柔性基材层103可完全覆盖柔性电极带101。当然,在其它实施例中,柔性基材层103的形状轮廓也可以等于或略小于柔性电极带101的形状轮廓。在优选的实施例中,柔性基材层103应使用具有可拉伸弹性或者还具有吸水性、透气性的材料制作,如:水刺无纺布、无纺布、泡棉、聚乙烯(PE)、聚对苯二甲酸乙二醇酯(PET)。Referring to FIGS. 5A and 5B, the shape profile of the flexible substrate layer 103 is such that the outer contour of the shape of the flexible electrode strip 101 is enlarged so that the flexible substrate layer 103 can completely cover the flexible electrode strip 101. Of course, in other embodiments, the shape profile of the flexible substrate layer 103 may also be equal to or slightly smaller than the shape profile of the flexible electrode strip 101. In a preferred embodiment, the flexible substrate layer 103 should be made of a material having stretch elasticity or also water absorption and gas permeability, such as spunlace nonwoven fabric, non-woven fabric, foam, polyethylene (PE). ), polyethylene terephthalate (PET).
在柔性基材层103上与柔性电极带101的连接器结构1011的接触面上还设有机械链接位1031,通过该机械链接位1031可以与连接器结构1011形成机械链接,从而固定住连接器结构1011,并且使柔性干电极1013及电气连接线1012与柔性基材层103的相对应位置在没有机械链接的情况下相对固定,不会水平位移或旋转。A mechanical link 1031 is also provided on the contact surface of the flexible substrate layer 103 with the connector structure 1011 of the flexible electrode strip 101, by which the mechanical link 1031 can form a mechanical link with the connector structure 1011, thereby fixing the connector. The structure 1011, and the corresponding positions of the flexible dry electrode 1013 and the electrical connection line 1012 and the flexible substrate layer 103 are relatively fixed without mechanical linkage, and are not horizontally displaced or rotated.
在柔性基材层103上与各柔性干电极1013对应的位置设有镂空细缝结构1032,镂空细缝结构1032用于穿过对应的柔性干电极1013,从而使得各柔性干电极1013置于柔性基材层103的底部。在优选的实施例中,镂空细缝结构1032到连接器结构1011与柔性基材层103机械连接点的距离小于其对应的柔性干电极1013到该机械连接点的距离。以便于当电信号采集设备100贴于人体体表待测部位时,柔性电极带101的电气连接线1012应弯曲并悬浮于柔性基材表面103,如图6A、图6B和图6C所示,从而避免了由于人体体表皮肤的拉伸或收缩而在电气连接线1012的拉力作用下导致柔性干电极1013与皮肤的相对位移,继而减小由于人体体表皮肤的拉伸或收缩而带来的信号恶化影响,譬如:基线漂移或运动鬼影等,提高人体体表电信号的采集质量。A hollow slit structure 1032 is provided on the flexible substrate layer 103 at a position corresponding to each of the flexible dry electrodes 1013, and the hollow slit structure 1032 is used to pass through the corresponding flexible dry electrode 1013, thereby placing the flexible dry electrodes 1013 in flexibility. The bottom of the substrate layer 103. In a preferred embodiment, the distance between the hollowed-slit structure 1032 to the mechanical connection point of the connector structure 1011 and the flexible substrate layer 103 is less than the distance of its corresponding flexible dry electrode 1013 to the mechanical connection point. In order to facilitate the electrical signal collection device 100 to be attached to the body surface to be tested, the electrical connection line 1012 of the flexible electrode strip 101 should be bent and suspended on the flexible substrate surface 103, as shown in FIGS. 6A, 6B and 6C. Thereby, the relative displacement of the flexible dry electrode 1013 and the skin caused by the tensile force of the electrical connection line 1012 due to the stretching or contraction of the skin of the human body surface is avoided, thereby reducing the stretching or contraction of the skin of the human body surface. The effects of signal degradation, such as baseline drift or motion ghosting, improve the quality of the body's surface electrical signals.
请参考图7A和图7B,薄膜粘贴层104的形状轮廓为柔性基材层103的形状轮廓外沿扩大,以使柔性基材层103可完全覆盖柔性基材层103。当然,在其它实施例中,柔性基材层103的形状轮廓也可以等于或略小于柔性基材层103的形状轮廓。在优选的实施例中,薄膜粘贴层104应使用具有可拉伸弹性或者还具有吸水性、透气性的材料制作,如:聚乙烯(PE)、聚对苯二甲酸乙二醇酯(PET)。Referring to FIGS. 7A and 7B, the shape of the film adhesive layer 104 is such that the outer contour of the shape of the flexible substrate layer 103 is enlarged so that the flexible substrate layer 103 can completely cover the flexible substrate layer 103. Of course, in other embodiments, the shape profile of the flexible substrate layer 103 may also be equal to or slightly smaller than the shape profile of the flexible substrate layer 103. In a preferred embodiment, the film adhesive layer 104 should be made of a material having stretch elasticity or also water absorption and gas permeability, such as polyethylene (PE) or polyethylene terephthalate (PET). .
在具体实施例中,薄膜粘贴层104 可以通过胶粘的方式与柔性基材层103进行贴合固定。在薄膜粘贴层104上与柔性基材层103贴合的区域应当均附有胶粘剂,以便于薄膜粘贴层104与柔性基材层103紧密贴合。In a specific embodiment, the film adhesive layer 104 The flexible substrate layer 103 can be attached and fixed by gluing. The adhesive layer on the film adhesive layer 104 and the flexible substrate layer 103 should be attached with an adhesive so that the film adhesive layer 104 and the flexible substrate layer 103 are closely adhered.
在薄膜粘贴层104上与各镂空细缝结构1032对应的位置设有开槽结构1041,开槽结构1041用于穿过镂空细缝结构1032所对应的柔性干电极1013。开槽结构1041到连接器结构1011与柔性基材层103机械连接点的距离小于其对应的镂空细缝结构1032到该机械连接点的距离。优选地,开槽结构1041可使对应的柔性干电极1013恰好穿过,且可使柔性干电极1013的背面同薄膜粘贴层104背面粘合后突出于薄膜粘贴层104背平面。从而,当电信号采集设备贴于人体体表后,如图8所示,柔性干电极1013可与人体体表皮肤形成良好、紧密的欧姆接触,继而,可以消除由于柔性干电极1013与皮肤接触不好而带来的信号恶化,提高人体体表电信号的采集质量,同时也避免了使用商用氯化银湿电极中为提升接触质量的导电胶/液,提高了本实施例设备的粘贴舒适度。A grooved structure 1041 is provided on the film adhesive layer 104 at a position corresponding to each of the hollow slit structures 1032, and the grooved structure 1041 is used to pass through the flexible dry electrode 1013 corresponding to the hollow slit structure 1032. The distance from the slotted structure 1041 to the mechanical joint of the connector structure 1011 to the flexible substrate layer 103 is less than the distance of its corresponding hollow slotted structure 1032 to the mechanical joint. Preferably, the slotted structure 1041 allows the corresponding flexible dry electrode 1013 to pass through, and the back surface of the flexible dry electrode 1013 can be adhered to the back surface of the film adhesive layer 104 after being bonded to the back surface of the film adhesive layer 104. Therefore, when the electrical signal collecting device is attached to the body surface, as shown in FIG. 8, the flexible dry electrode 1013 can form a good and tight ohmic contact with the skin of the human body surface, and then, the contact with the skin due to the flexible dry electrode 1013 can be eliminated. The deterioration of the signal caused by the bad, improving the collection quality of the body surface electrical signal, and also avoiding the use of the conductive glue/liquid in the commercial silver chloride wet electrode for improving the contact quality, improving the bonding comfort of the device of the embodiment. degree.
请参考图7B,薄膜粘贴层104的底部(与人体体表接触的一面)附着的胶粘剂1044至少分布在各柔性干电极1013的拟粘贴区域1046,或者还分布于各柔性干电极1013的有限外延区域1045。从而,当电信号采集设备100贴于人体体表后,如图9所示,当人体体表皮肤由于人体运动而突出或凹陷时,采集设备100可以在保证干电极与体表皮肤粘贴位置不变且接触良好的情况下,自适应的调节采集设备100与体表皮肤的贴合形态以及相对位置,这样可以在保证采集设备100采集到的人体体表电信号质量的同时,也提高了采集设备100的粘贴舒适度。Referring to FIG. 7B, the adhesive 1044 attached to the bottom of the film adhesive layer 104 (the side in contact with the body surface) is distributed at least in the intended adhesion region 1046 of each flexible dry electrode 1013, or is also distributed over the limited epitaxy of each flexible dry electrode 1013. Area 1045. Therefore, when the electrical signal collecting device 100 is attached to the body surface, as shown in FIG. 9, when the skin of the human body is protruded or recessed due to the movement of the human body, the collecting device 100 can ensure the position of the dry electrode and the skin of the body surface. When the contact is good and the contact is good, the adaptive adjustment of the matching shape and the relative position of the collection device 100 and the skin of the body surface can ensure the quality of the electrical signal of the human body surface collected by the collection device 100, and also improve the collection. The paste comfort of the device 100.
在优选的实施例中,胶粘剂1044应使用皮肤粘性强,顺应性好,不易引起皮肤敏感的材料制作,如:丙烯酸酯、合成橡胶。In a preferred embodiment, the adhesive 1044 should be made of a material that is highly viscous, conformable, and less susceptible to skin sensitivity, such as acrylates, synthetic rubbers.
在具体实施例中,请参考图10,电路单元102可以包括:对来自柔性电极带102中的柔性干电极1013的信号放大、滤波、数模转换的信号调理电路1021;用于数据处理、数据转发、控制的中央处理电路1022;用于数据暂存的存储电路1023;用于数据发送的通讯电路1024;还可以进一步包括用于供电的电源管理电路1025。电路单元102封装于密封套壳1026中,仅有信号连接件1027露出密封套壳,信号连接件1027能够与柔性电极带101中信号输出端形成电气连接。In a specific embodiment, referring to FIG. 10, the circuit unit 102 may include: a signal conditioning circuit 1021 for amplifying, filtering, and digital-to-analoging signals from the flexible dry electrode 1013 in the flexible electrode strip 102; for data processing, data A central processing circuit 1022 for forwarding, control, a storage circuit 1023 for data temporary storage, a communication circuit 1024 for data transmission, and a power management circuit 1025 for power supply. The circuit unit 102 is encapsulated in the hermetic casing 1026, only the signal connector 1027 is exposed to the hermetic casing, and the signal connector 1027 is capable of forming an electrical connection with the signal output terminal of the flexible electrode strip 101.
请参考图11A和图11B,机壳105的形状轮廓与薄膜粘贴层104的形状轮廓一致,机壳105与薄膜粘贴层104固定连接,在具体实施例中,可以通过胶粘剂与薄膜粘贴层104固定连接。机壳105的材质为具有抗压性,在优选的实施例中,机壳105的材质还具有可拉伸弹性、防水、防尘、耐弱酸碱腐蚀的材料,譬如硅胶等。Referring to FIG. 11A and FIG. 11B, the shape contour of the casing 105 is consistent with the shape contour of the film bonding layer 104, and the casing 105 is fixedly connected to the film bonding layer 104. In a specific embodiment, it may be fixed by the adhesive and the film bonding layer 104. connection. The material of the casing 105 is pressure-resistant. In a preferred embodiment, the material of the casing 105 also has a material that is stretchable, waterproof, dustproof, and resistant to weak acid and alkali corrosion, such as silica gel.
在其它实施例中,当薄膜粘贴层104的形状轮廓略小于柔性基材层103的形状轮廓时,即薄膜粘贴层104形状轮廓为柔性基材层103形状轮廓的有限内缩时,则薄膜粘贴层104形状轮廓应大于柔性电极带101的形状轮廓,此时,机壳105则应固定例如粘合在柔性基材层103上。In other embodiments, when the shape profile of the film adhesive layer 104 is slightly smaller than the shape profile of the flexible substrate layer 103, that is, the shape of the film adhesive layer 104 is a limited retraction of the shape profile of the flexible substrate layer 103, the film is pasted. The shape contour of the layer 104 should be larger than the shape profile of the flexible electrode strip 101, in which case the housing 105 should be fixed, for example, bonded to the flexible substrate layer 103.
请参考图11B,机壳105由边缘向中部逐渐隆起,能在其内部形成空腔1052,并承受一定力量的撞击。电路单元102置于该空腔1052内,譬如,机壳105中部有机械链接卡扣结构1051或者其它能够固定住电路单元102的机械结构,电路单元102可以通过该卡扣结构1051置于该空腔1052内。在一具体实施例中,电路单元102不可拆卸固定在空腔1052内;在另一具体实施例中,电路单元102也可以可拆卸放置于空腔1052内。Referring to FIG. 11B, the casing 105 is gradually raised from the edge toward the center, and a cavity 1052 can be formed therein and subjected to a certain force impact. The circuit unit 102 is disposed in the cavity 1052. For example, a mechanical link snap structure 1051 or other mechanical structure capable of holding the circuit unit 102 is disposed in the middle of the casing 105, and the circuit unit 102 can be placed in the air through the snap structure 1051. Inside the cavity 1052. In one embodiment, the circuit unit 102 is non-detachably secured within the cavity 1052; in another embodiment, the circuit unit 102 can also be removably placed within the cavity 1052.
请参考图10和图11B,电路单元102的密封套壳1026表面有机械链接卡扣10261,能够与机壳105中的机械链接卡扣1051形成机械链接。机壳105中部有机械链接卡扣结构1051,可将电路单元102卡入机壳105内,使电路单元102的密封套壳1026表面的机械链接卡扣结构10261进行机械链接,使电路单元102被机壳105完全包裹,且不可从整个设备中拆卸。Referring to FIG. 10 and FIG. 11B, the sealing sleeve 1026 of the circuit unit 102 has a mechanical link buckle 10261 on its surface, which can form a mechanical link with the mechanical link buckle 1051 in the casing 105. A mechanical link snap structure 1051 is formed in the middle of the casing 105, and the circuit unit 102 can be inserted into the casing 105 to mechanically link the mechanical link buckle structure 10261 on the surface of the sealed casing 1026 of the circuit unit 102, so that the circuit unit 102 is The casing 105 is completely wrapped and cannot be removed from the entire device.
请参考图12A、12B和图12C,机壳105的顶部具有空腔1052相通的开窗结构1053,开窗形状轮廓与的电路单元102的密封套壳1026形状轮廓一致。电路单元102可恰好嵌入机壳105内,使电路单元102的密封套壳1026表面的机械链接卡扣结构10261进行机械链接,使电路单元102被机壳105间无缝隙,且可从整个设备中拆卸。采用电路单元102与机壳105可拆卸连接的优点在于,电路单元102可多次使用,而电信号采集设备100的其余装配在一起的部件作为一个整体是一次性使用的。可见,电信号采集设备100作为可重复性医疗器械使用时,与人体体表接触的部件如柔性电极带101、柔性基材层103和薄膜粘贴层104可以作为单人单次的耗材,而未与人体体表接触的电路单元102可以作为多人多次使用的公用部件。如此,在使用本实施例提供的电信号采集设备进行人体体表电信号采集时,能够在保证安全、卫生的前提下,可尽量减少成本和资源的消耗。Referring to FIGS. 12A, 12B and 12C, the top of the casing 105 has a window opening structure 1053 through which the cavity 1052 communicates, and the window shape contour conforms to the shape of the sealing casing 1026 of the circuit unit 102. The circuit unit 102 can be embedded in the casing 105 to mechanically link the mechanical link buckle structure 10261 on the surface of the sealed casing 1026 of the circuit unit 102, so that the circuit unit 102 is free of gaps between the casings 105 and can be from the entire device. Disassembled. An advantage of the detachable connection of the circuit unit 102 to the housing 105 is that the circuit unit 102 can be used multiple times, while the remaining assembled components of the electrical signal acquisition device 100 as a single unit are disposable. It can be seen that when the electrical signal acquisition device 100 is used as a reproducible medical device, components that are in contact with the body surface, such as the flexible electrode strip 101, the flexible substrate layer 103, and the film adhesive layer 104, can be used as a single-use single-use consumable. The circuit unit 102 in contact with the body surface can be used as a common component for multiple use by multiple people. In this way, when the electrical signal collection device provided by the embodiment is used to collect the electrical signals of the human body surface, the cost and resource consumption can be minimized under the premise of ensuring safety and sanitation.
本实施例还公开了一种可粘贴体表电信号采集设备的装配方法,包括如下步骤:The embodiment also discloses an assembly method of the affixable body surface electrical signal collecting device, which comprises the following steps:
粘贴步骤,将柔性基材层103与薄膜粘贴层104对迎面相粘合;a bonding step of bonding the flexible substrate layer 103 and the film adhesive layer 104 to the front surface;
机械固定步骤,将柔性电极带101的连接器结构1011与柔性基材层103相应位置机械链接并固定;a mechanical fixing step of mechanically linking and fixing the connector structure 1011 of the flexible electrode strip 101 to the corresponding position of the flexible substrate layer 103;
穿透步骤,将柔性电极带101的柔性干电极1013依次穿过柔性基材层103的镂空细缝结构1032和薄膜粘贴层104的开槽结构1041,并将柔性干电极1013的非与人体体表接触面粘贴至薄膜粘贴层104的拟粘贴区域。In the penetrating step, the flexible dry electrode 1013 of the flexible electrode strip 101 is sequentially passed through the hollow slit structure 1032 of the flexible substrate layer 103 and the slotted structure 1041 of the film adhesive layer 104, and the non-human body of the flexible dry electrode 1013 The surface contact surface is pasted to the intended adhesion area of the film adhesive layer 104.
在优选的实施例中,当电信号采集设备还包括机壳105时,则在穿透步骤之后还包括如下步骤:In a preferred embodiment, when the electrical signal collecting device further includes the casing 105, the following steps are further included after the penetrating step:
在一种具体实施例中,当薄膜粘贴层104的形状轮廓大于柔性基材层103的形状轮廓时,则将机壳105的边沿与薄膜粘贴层104粘合;In a specific embodiment, when the shape contour of the film adhesive layer 104 is larger than the shape contour of the flexible substrate layer 103, the edge of the casing 105 is bonded to the film adhesive layer 104;
在另一种具体实施例中,当薄膜粘贴层104的形状轮廓略小于或等于柔性基材层103的形状轮廓时,则将机壳105的边沿与柔性基材层103粘合。In another specific embodiment, the edge of the casing 105 is bonded to the flexible substrate layer 103 when the shape profile of the film-attachment layer 104 is slightly less than or equal to the shape profile of the flexible substrate layer 103.
在优选的实施例中,当电信号采集设备还包括电路单元102,且该电路单元102为不可拆卸置于机壳105时,则应先将电路单元102固定在机壳105的空腔1052内,而后再将机壳105的边沿与薄膜粘贴层104或柔性基材层103粘合。In a preferred embodiment, when the electrical signal acquisition device further includes the circuit unit 102, and the circuit unit 102 is non-detachably disposed in the casing 105, the circuit unit 102 should be first fixed in the cavity 1052 of the casing 105. Then, the edge of the casing 105 is bonded to the film adhesive layer 104 or the flexible substrate layer 103.
在其它实施例中,柔性可粘贴体表电信号采集设备的其他部件可以柔性电极带101的形状轮廓为基础演绎并装配。In other embodiments, other components of the flexible attachable surface electrical signal acquisition device can be deducted and assembled based on the shape profile of the flexible electrode strip 101.
本实施例公开的可粘贴体表电信号采集设备可以用于采集人体体表的心电信号、肌电信号或皮肤电阻抗信号,且具有以下优点:The affixable body surface electrical signal collecting device disclosed in this embodiment can be used for collecting an electrocardiogram signal, an electromyogram signal or a skin electrical impedance signal of a human body surface, and has the following advantages:
本实施例公开的可粘贴体表电信号采集设备的柔性干电极可与人体体表皮肤形成良好、紧密的欧姆接触,即能消除由于干电极与皮肤接触不好而带来的信号恶化效果,提高人体体表电信号的采集质量,同时也避免了使用商用氯化银湿电极中为提升接触质量的导电胶/液,提高了本实施例设备的粘贴舒适度。The flexible dry electrode of the affixable body surface electrical signal collecting device disclosed in this embodiment can form a good and tight ohmic contact with the skin of the human body surface, that is, the signal deterioration effect caused by poor contact between the dry electrode and the skin can be eliminated. The collection quality of the body surface electrical signal is improved, and the conductive glue/liquid for improving the contact quality in the commercial silver chloride wet electrode is also avoided, thereby improving the paste comfort of the device of the embodiment.
进一步,由于柔性电极带与电路单元集成于同一设备中,使得心电信号或肌电信号或皮肤电阻抗信号的采集过程无需导联线,提高了采集过程的便捷性和舒适性;同时,由于体表电信号的传导过程没有导联线,采集到的信号中将不存在传统设备中由导联线引入的噪声和干扰信号,提高信号采集质量。Further, since the flexible electrode strip and the circuit unit are integrated in the same device, the collection process of the electrocardiogram signal or the electromyogram signal or the skin electrical impedance signal does not require a lead wire, thereby improving the convenience and comfort of the acquisition process; There is no lead wire in the conduction process of the surface electrical signal. The collected signal will not have the noise and interference signals introduced by the lead wire in the traditional device, which improves the signal acquisition quality.
此外,由于电信号采集设备按上述实施例制造和装配,使得电信号采集设备无需携带体积设备,可以像创口贴一样直接贴附于胸前、手臂、腿部等需采集心电信号或肌电信号或皮肤电阻抗信号的人体体表待测部位,且采集过程不会影响佩戴者的正常生活工作活动,适用于对心电信号或肌电信号或皮肤电阻抗信号的长时间、连续地采集,所采集到的信号数据更具价值。对用户而言,使用过程舒适,极适用于佩戴时间大于七十二小时的情况。In addition, since the electric signal collecting device is manufactured and assembled according to the above embodiment, the electric signal collecting device does not need to carry the volume device, and can be directly attached to the chest, the arm, the leg, etc. like the wound patch, and needs to collect the electrocardiogram signal or the myoelectricity. Signal or skin electrical impedance signal of the body surface to be tested, and the acquisition process does not affect the wearer's normal living activities, suitable for long-term, continuous collection of ECG signals or EMG signals or skin electrical impedance signals The collected signal data is more valuable. For the user, the process is comfortable and very suitable for wearing for more than 72 hours.
以上应用了具体个例对本发明进行阐述,只是用于帮助理解本发明并不用以限制本发明。对于本领域的一般技术人员,依据本发明的思想,可以对上述具体实施方式进行变化。The invention has been described above with reference to specific examples, and is intended to be illustrative of the invention. Variations to the above-described embodiments may be made in accordance with the teachings of the present invention.

Claims (21)

  1. 一种可粘贴体表电信号采集设备,其特征在于,包括:自上至下依次布置的柔性电极带(101)、柔性基材层(103)和薄膜粘贴层(104); An affixable body surface electrical signal collecting device, comprising: a flexible electrode strip (101), a flexible substrate layer (103) and a film adhesive layer (104) arranged in order from top to bottom;
    柔性电极带(101)包括集成多个放射状的柔性干电极(1013)以及与各柔性干电极(1013)耦合的信号输出端;各柔性干电极(1013)用于采集人体待测部位的电信号;信号输出端用于输出各柔性干电极(1013)所采集的电信号;The flexible electrode strip (101) includes a plurality of radial flexible dry electrodes (1013) and signal output ends coupled to the respective flexible dry electrodes (1013); each flexible dry electrode (1013) is used to collect electrical signals of the body to be tested. The signal output is used to output an electrical signal collected by each flexible dry electrode (1013);
    各柔性干电极(1013)穿透于柔性基材层(103)和薄膜粘贴层(104)位于薄膜粘贴层(104)的底部与薄膜粘贴层(104)贴合;Each flexible dry electrode (1013) penetrates the flexible substrate layer (103) and the film adhesive layer (104) is disposed at the bottom of the film adhesive layer (104) and adheres to the film adhesive layer (104);
    薄膜粘贴层(104)的底部附着有胶粘剂(1044),胶粘剂(1044)用于粘贴住各柔性干电极(1013)和薄膜粘贴层(104),还用于粘贴住人体体表待测部位。An adhesive (1044) is attached to the bottom of the film adhesive layer (104). The adhesive (1044) is used to adhere the flexible dry electrodes (1013) and the film adhesive layer (104), and is also used for sticking the body surface to be tested.
  2. 如权利要求1所述的采集设备,其特征在于,各柔性干电极(1013)以信号输出端为平面中心向外呈放射状。The acquisition device of claim 1 wherein each of the flexible dry electrodes (1013) is radially outward with the signal output end being planar.
  3. 如权利要求1所述的采集设备,其特征在于,各柔性干电极(1013)用于与人体体表接触的一面为微针阵列。 The collection device according to claim 1, wherein each of the flexible dry electrodes (1013) for contacting the body surface is a microneedle array.
  4. 如权利要求3所述的采集设备,其特征在于,所述微针阵列表面还覆有银或氯化银。The collection device of claim 3 wherein said microneedle array surface is further coated with silver or silver chloride.
  5. 如权利要求1所述的采集设备,其特征在于,柔性电极带(101)包括连接器结构(1011),信号输出端固定在连接器结构(1011)上;柔性电极带(101)通过该连接器结构(1011)与柔性基材层(103)机械连接;各柔性干电极(1013)通过电气连接线(1012)耦合至信号输出端。The acquisition device according to claim 1, wherein the flexible electrode strip (101) comprises a connector structure (1011), the signal output end being fixed to the connector structure (1011); and the flexible electrode strip (101) passing through the connection The device structure (1011) is mechanically coupled to the flexible substrate layer (103); each flexible dry electrode (1013) is coupled to the signal output via an electrical connection (1012).
  6. 如权利要求5所述的采集设备,其特征在于,在柔性基材层(103)上与各柔性干电极(1013)对应的位置设有镂空细缝结构(1032);镂空细缝结构(1032)用于穿过对应的柔性干电极(1013); The collecting device according to claim 5, characterized in that a hollow slit structure (1032) is provided at a position corresponding to each flexible dry electrode (1013) on the flexible substrate layer (103); a hollow slit structure (1032) ) for passing through the corresponding flexible dry electrode (1013);
    镂空细缝结构(1032)到连接器结构(1011)与柔性基材层(103)机械连接点的距离小于其对应的柔性干电极(1013)到该机械连接点的距离。The distance between the hollow sipe structure (1032) to the mechanical connection point of the connector structure (1011) and the flexible substrate layer (103) is less than the distance of its corresponding flexible dry electrode (1013) to the mechanical connection point.
  7. 如权利要求6所述的采集设备,其特征在于,在薄膜粘贴层(104)上与各镂空细缝结构(1032)对应的位置设有开槽结构(1041);开槽结构(1041)用于穿过镂空细缝结构(1032)所对应的柔性干电极(1013);The collecting device according to claim 6, wherein a grooved structure (1041) is provided on the film adhesive layer (104) at a position corresponding to each of the hollow slit structures (1032); and the grooved structure (1041) is used. a flexible dry electrode (1013) corresponding to the hollowed-out slit structure (1032);
    开槽结构(1041)到连接器结构(1011)与柔性基材层(103)机械连接点的距离小于其对应的镂空细缝结构(1032)到该机械连接点的距离。The distance from the slotted structure (1041) to the mechanical connection point of the connector structure (1011) to the flexible substrate layer (103) is less than the distance of its corresponding hollow sipe structure (1032) to the mechanical connection point.
  8. 如权利要求1所述的采集设备,其特征在于,柔性基材层(103)的形状轮廓为柔性电极带(101)的形状轮廓外沿扩大;薄膜粘贴层(104)的形状轮廓为柔性基材层(103)的形状轮廓外沿扩大。The acquisition device according to claim 1, wherein the shape of the flexible substrate layer (103) is such that the outer contour of the shape of the flexible electrode strip (101) is enlarged; the shape of the adhesive layer (104) is a flexible base. The outer edge of the shape contour of the material layer (103) is enlarged.
  9. 如权利要求1所述的采集设备,其特征在于,柔性基材层(103)和薄膜粘贴层(104)的材质具有可拉伸弹性,或者还具有吸水性和/或透气性。The collection device according to claim 1, wherein the material of the flexible substrate layer (103) and the film adhesive layer (104) has stretchable elasticity or also has water absorbency and/or gas permeability.
  10. 如权利要求1所述的采集设备,其特征在于,薄膜粘贴层(104)底部附着的胶粘剂(1044)至少分布在各柔性干电极(1013)的拟粘贴区域,或者还分布于各柔性干电极(1013)的有限外延区域。The collecting device according to claim 1, wherein the adhesive (1044) attached to the bottom of the film adhesive layer (104) is distributed at least in the area to be pasted of each flexible dry electrode (1013), or is also distributed on each flexible dry electrode. The finite epitaxial region of (1013).
  11. 如权利要求1-10任意一项所述的采集设备,其特征在于,还包括:The collection device according to any one of claims 1 to 10, further comprising:
    电路单元(102),电路单元(102)耦合至信号输出端,用于处理信号输出端输出的电信号。A circuit unit (102) coupled to the signal output for processing an electrical signal output by the signal output.
  12. 如权利要求1-10任意一项所述的采集设备,其特征在于,还包括:The collection device according to any one of claims 1 to 10, further comprising:
    机壳(105),用于从柔性电极带(101)上部包裹住柔性电极带(101)、柔性基材层(103)和薄膜粘贴层(104)。The casing (105) is for wrapping the flexible electrode strip (101), the flexible substrate layer (103) and the film sticking layer (104) from the upper portion of the flexible electrode strip (101).
  13. 如权利要求12所述的采集设备,其特征在于,机壳(105)的形状轮廓与薄膜粘贴层(104)的形状轮廓一致,机壳(105)与薄膜粘贴层(104)固定连接。The collecting device according to claim 12, wherein the shape contour of the casing (105) is identical to the shape contour of the film bonding layer (104), and the casing (105) is fixedly coupled to the film bonding layer (104).
  14. 如权利要求13所述的采集设备,其特征在于,机壳(105)通过胶粘剂与薄膜粘贴层(104)固定连接。The collection device according to claim 13, wherein the casing (105) is fixedly coupled to the film adhesive layer (104) by an adhesive.
  15. 如权利要求12所述的采集设备,其特征在于,所述机壳(105)的材质为具有抗压性,或者还具有可拉伸弹性。The collecting device according to claim 12, wherein the casing (105) is made of a pressure resistance or has a stretchable elasticity.
  16. 如权利要求12所述的采集设备,其特征在于,还包括:The collection device of claim 12, further comprising:
    电路单元(102),电路单元(102)耦合至信号输出端,用于处理信号输出端输出的电信号;a circuit unit (102) coupled to the signal output for processing an electrical signal output by the signal output;
    所述机壳(105)具有空腔(1052),所述电路单元(102)置于所述空腔(1052)。The casing (105) has a cavity (1052), and the circuit unit (102) is placed in the cavity (1052).
  17. 如权利要求16所述的采集设备,其特征在于,所述电路单元(102)不可拆卸固定在所述空腔(1052)内。The acquisition device of claim 16 wherein said circuit unit (102) is non-detachably secured within said cavity (1052).
  18. 如权利要求17所述的采集设备,其特征在于,所述电路单元(102)通过卡扣固定在所述空腔(1052)内。The acquisition device of claim 17 wherein said circuit unit (102) is secured within said cavity (1052) by a snap.
  19. 如权利要求16所述的采集设备,其特征在于,所述机壳(105)顶部具有与所述空腔(1052)相通的开窗结构(1053),所述电路单元(102)可拆卸放置于所述空腔(1052)。The collecting device according to claim 16, wherein the top of the casing (105) has a window opening structure (1053) communicating with the cavity (1052), and the circuit unit (102) is detachably placed. In the cavity (1052).
  20. 一种可粘贴体表电信号采集设备的装配方法,其特征在于,包括:An assembly method for attaching a surface electrical signal acquisition device, comprising:
    粘贴步骤,将柔性基材层(103)与薄膜粘贴层(104)对迎面相粘合;a bonding step of bonding the flexible substrate layer (103) and the film adhesive layer (104) to the front surface;
    机械固定步骤,将柔性电极带(101)的连接器结构(1011)与柔性基材层(103)相应位置机械链接并固定;a mechanical fixing step of mechanically linking and fixing the connector structure (1011) of the flexible electrode strip (101) to the corresponding position of the flexible substrate layer (103);
    穿透步骤,将柔性电极带(101)的柔性干电极(1013)依次穿过柔性基材层(103)的镂空细缝结构(1032)和薄膜粘贴层(104)的开槽结构(1041),并将柔性干电极(1013)的非与人体体表接触面粘贴至薄膜粘贴层(104)的拟粘贴区域。In the penetrating step, the flexible dry electrode (1013) of the flexible electrode strip (101) is sequentially passed through the hollow slit structure (1032) of the flexible substrate layer (103) and the slotted structure of the film adhesive layer (104) (1041) And attaching the non-contact surface of the flexible dry electrode (1013) to the human body surface to the intended adhesion area of the film adhesive layer (104).
  21. 如权利要求20所述的装配方法,其特征在于,在穿透步骤之后还包括:The assembly method according to claim 20, further comprising: after the penetrating step:
    将机壳(105)的边沿与薄膜粘贴层(104)或柔性基材层(103)粘合;或者,Bonding the edge of the casing (105) to the film adhesive layer (104) or the flexible substrate layer (103); or,
    将电路单元(102)固定在机壳(105)的空腔(1052)内,并将机壳(105)的边沿与薄膜粘贴层(104)或柔性基材层(103)粘合。 The circuit unit (102) is fixed in the cavity (1052) of the casing (105), and the edge of the casing (105) is bonded to the film adhesive layer (104) or the flexible substrate layer (103).
PCT/CN2014/095821 2014-12-31 2014-12-31 Affixable body surface electric signal collecting device and mounting method therefor WO2016106647A1 (en)

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