WO2021093789A1 - Wristband-type biological signal acquisition device and manufacturing method therefor - Google Patents

Wristband-type biological signal acquisition device and manufacturing method therefor Download PDF

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Publication number
WO2021093789A1
WO2021093789A1 PCT/CN2020/128200 CN2020128200W WO2021093789A1 WO 2021093789 A1 WO2021093789 A1 WO 2021093789A1 CN 2020128200 W CN2020128200 W CN 2020128200W WO 2021093789 A1 WO2021093789 A1 WO 2021093789A1
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Prior art keywords
microneedle
wristband
biological signal
microneedle array
signal acquisition
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PCT/CN2020/128200
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French (fr)
Chinese (zh)
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王迎英
方鹏
田岚
李向新
李光林
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深圳先进技术研究院
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/296—Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/685—Microneedles
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C14/00—Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material
    • C23C14/06—Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material characterised by the coating material
    • C23C14/14—Metallic material, boron or silicon
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C14/00—Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material
    • C23C14/22—Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material characterised by the process of coating
    • C23C14/34—Sputtering
    • C23C14/35—Sputtering by application of a magnetic field, e.g. magnetron sputtering
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A61B2562/125—Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02405—Determining heart rate variability

Definitions

  • the invention relates to the technical field of biological signal acquisition, in particular to a wristband type biological signal acquisition device and a manufacturing method thereof.
  • Biological signals include electromyography (EMG), electrocardiography (ECG), etc. monitoring, which is currently an important means for early diagnosis of human health and diseases in various biomedical fields.
  • EMG monitoring can be used for the diagnosis of neuromuscular diseases, the detection of muscle motor function, and the control of prostheses; and the analysis of heart rate variability (HRV) by recording ECG signals can be applied to cardiovascular diseases (hypertension, myocardial infarction) , Prediction of sudden cardiac death, coronary heart disease, congestive heart failure, etc.) diagnosis and evaluation of autonomic nervous function (including diabetes, thyroid dysfunction, obstetrics and gynecology, respiratory disease, anesthesia accident prediction, etc.).
  • EMG monitoring can be used for the diagnosis of neuromuscular diseases, the detection of muscle motor function, and the control of prostheses
  • HRV heart rate variability
  • the collection of bioelectric signals necessarily requires electrodes and collection systems, but the traditional biosignal collection electrodes are silver/silver chloride (Ag/AgCl) electrodes, which need to be pasted on the surface of the tested skin with conductive gel or medical tape , And the conductive gel penetrates into the stratum corneum to reduce the electrode-skin interface impedance (EII), thereby collecting bioelectric signals.
  • conductive gel will dry out gradually over time and increase EII, on the other hand, it will cause damage to some users with sensitive skin. Therefore, the current Ag/AgCl wet electrodes are disposable and cannot be used Long-term monitoring. Dry electrodes do not require conductive gel and can be used instead of wet electrodes.
  • the microneedle array electrode is expected to overcome the problems of traditional electrodes.
  • the existing Ag/AgCl wet electrode will be affected by environmental temperature, humidity changes and the passage of time due to the conductive gel, and it is not suitable for people with sensitive skin, and a suitable dry electrode is needed to replace it.
  • the existing dry electrode cannot achieve stable collection of biological signals due to its large interface impedance (EII) in contact with the skin, and it is susceptible to interference from movement, pulling, and the like.
  • the microneedle array electrode reduces EII because its microneedle can penetrate the stratum corneum to reach the active epidermis with low impedance, and the microneedle electrode is in stable contact with the skin, which can reduce the interference of movement, so it is expected to overcome the difficulties of the above-mentioned electrodes. Realize long-term biological signal detection.
  • microneedle array electrodes can be used to collect bioelectric signals, but there is no complete wearable system based on array electrodes, and the wearing of the electrodes still needs to be fixed with tape, etc., which is sensitive to some skins. Of users are still a problem.
  • the purpose of the present invention is to overcome the above-mentioned defects of the prior art, and provide a wristband type biological signal acquisition device and a manufacturing method thereof, based on a microarray electrode design that is simple to use, easy to carry, safe and comfortable wearable device.
  • a wristband type biological signal acquisition device includes a wristband, a microneedle array formed on a microneedle array substrate, and a biological signal output interface, wherein the microneedle array is fixed on the wristband and contacts the wearer's wrist skin, and the biological signal
  • the output interface is connected with the microneedle array electrode to output the collected biological signal.
  • the microneedle array substrate is a flexible circuit board
  • the conductive chassis of the microneedle array substrate is circular
  • the diameter of the circular chassis is 800um.
  • the microneedle array includes a plurality of microneedles with the same or different structures.
  • the multiple microneedles of the microneedle array have the same structure, each microneedle is conical, the bottom diameter of each microneedle connected to the microneedle array substrate is 750um, and the diameter of the needle tip is 20um. , The length of the microneedle is 500um ⁇ 600um.
  • the overall size of the microneedle array is 8 mm ⁇ 5 mm, and the plurality of microneedles of the microneedle array are 4 ⁇ 6 microneedles distributed in a rectangular shape, and the center spacing of the microneedles is 1 mm.
  • the microneedle array substrate is polyimide.
  • the microneedle material of the microneedle array is a mixture of epoxy resin A, solvent B and pure iron powder, wherein the volume ratio of epoxy resin A to solvent B is 3:1, epoxy resin A , The weight ratio of B solvent to pure iron powder is 1:0.7.
  • multiple microneedle arrays are provided on the wristband for collecting multi-channel biological signals.
  • a manufacturing method of a wristband type biological signal acquisition device includes: making a flexible substrate for the microneedle array; forming a microneedle array on the chassis of the flexible substrate by magnetic pulling technology; curing the microneedle array, and vacuuming the surface of the microneedle array by magnetron sputtering coating technology Sputter a layer of metal with uniform texture; make a biological signal output interface; choose clothing materials to make a wristband, and assemble the made microneedle array, wires, and biological signal output interface into the wristband.
  • the magnetron sputtering parameters are set as: Ti, reaction pressure 1pa, sputtering power 300W, sputtering time 5S, thickness 5nm; Au, reaction pressure 1pa, sputtering power 200W, sputtering time 60S, thickness 100nm.
  • the present invention has the advantages of providing a low-cost, easy-to-use, easy-to-carry, safe and comfortable wearable device, and the user can wear the device for a long time and continuously and stably record biosignals at rest and in motion.
  • the device For amputee users, you can wear the device for a long time to collect biological signals for movement intention recognition, in order to cooperate with the control of the prosthesis, the user will not feel discomfort due to wearing electrodes for a long time; the user can wear the device in daily life scenes
  • the device records stable biological signals when sitting, standing, and walking on different terrains, and the recorded signals can be used for HRV (heart rate variability) analysis, etc.; users can flexibly choose different wristbands according to their needs to choose to record different separately or at the same time Types of biological signals.
  • Fig. 1 is a schematic diagram of a microneedle array electrode substrate according to an embodiment of the present invention
  • FIG. 2 is a schematic diagram of a wristband type microneedle array electrode for recording myoelectric signals according to an embodiment of the present invention
  • FIG. 3 is a schematic diagram of a wristband type microneedle array electrode for recording ECG signals according to an embodiment of the present invention
  • Fig. 4 is a flow chart of data processing of electromyographic signals and electrocardiographic signals according to an embodiment of the present invention.
  • the invention provides a biosignal acquisition device with a wearable wristband type microneedle array electrode that is low in cost, simple to use, convenient to carry, safe and comfortable, and can be used for long-term monitoring of bioelectric signals in daily life environments, such as EMG and ECG.
  • the whole electrode sheet 100 includes 24 microneedle electrodes.
  • the chassis of a single microneedle electrode is labeled 101, the electrode substrate 102, and the electrode and signal acquisition device interface 103 is shown. , Is also referred to as the biological signal output interface 103 herein.
  • the electrode chassis 101 can be made of metal materials, such as copper; the electrode substrate 102 can be made of flexible circuit board materials, such as polyimide; the biological signal output interface 103 is used to transmit the collected signals to an external data processing device (such as a computer). ), the data processing equipment or the existing wireless data acquisition system can be communicated in a wired or wireless manner, and the biosignal output interface 103 and the microneedle electrode can be electrically connected through a wire (not shown).
  • a wristband-type biosignal acquisition device can be made according to the following steps:
  • Step S110 Determine the parameters of the microneedle electrode.
  • the microneedle electrode needs to have a proper aspect ratio.
  • the epidermis includes the stratum corneum and the active epidermis.
  • the stratum corneum is composed of keratinocytes, with a thickness of about 15um to 20um, and has high impedance, while the thickness of the active epidermis is about 200um, which has high conductivity; while the dermis is distributed with Blood vessels, receptors, etc. If the microneedles penetrate the dermis of the skin, it will cause pain and possibly injury.
  • the penetration depth of the microneedles is set between 20um and 200um. Because the skin is soft, it is impossible for the microneedles to penetrate the skin completely.
  • the length of the microneedles is reduced It is set to 500um ⁇ 600um to ensure that the microneedle can penetrate the stratum corneum without causing skin damage.
  • the microneedle is set in a conical shape, the diameter of the bottom is about 750um, and the diameter of the needle tip is about 20um.
  • the overall size of a microneedle array electrode is about 8mm ⁇ 5mm, and it is composed of 24 microneedles in a rectangular distribution of 4 ⁇ 6, and the center spacing of the microneedles is 1 mm.
  • This arrangement can ensure a sufficient contact area between the microneedle electrode and the skin, and also ensure that the size of the electrode is not too large.
  • the limitation of the center distance of adjacent microneedle electrodes not only ensures a suitable electrode size, but also ensures minimally invasive skin, and does not cause too small center distances to cause pinholes to be too dense.
  • microneedle height is flexibly adjustable, and the structure of each microneedle can be the same or different.
  • Microneedles with different heights can be set.
  • step S120 a substrate of the electrode is fabricated.
  • the substrate can be made of polyimide with high heat resistance and good dimensional stability.
  • the design is light and thin, has good flexibility, and can fit the human body better when the wiring density is high.
  • the conductive chassis material of the needle electrode is copper, and the diameter of the circular chassis is 800um.
  • the microneedle electrode substrate is a polyimide flexible circuit board, and the hardness can ensure that the microneedle can penetrate the skin relatively easily, and at the same time, it can be well combined with the wristband and fit the skin.
  • step S130 the microneedle is pulled out from the bottom plate of the electrode base.
  • the magnetic traction method can be used to pull out the microneedles on the chassis of the substrate.
  • the material of the microneedles can be silicon, polymer or metal.
  • a pogo needle with a diameter of about 0.7 mm is used to dip the mixed reagent droplets on the base of the prepared flexible substrate, and the microneedles are pulled out in a magnetic field with a magnetic field strength of about 2000 Gauss. Then, place it in the middle of the magnet at room temperature for 24 hours until the microneedle is completely cured, paste the mask, and coat a layer of gold on the microneedle by magnetron sputtering.
  • the magnetron parameter is set to Ti,
  • the reaction pressure is 1pa, the sputtering power is 300W, the sputtering time is 5S, and the thickness is about 5nm;
  • Au the reaction pressure is 1pa, the sputtering power is 200W, the sputtering time is 60S, and the thickness is about 100nm.
  • a microneedle array with high mechanical strength and high stability is prepared on a flexible substrate.
  • the flexible material can produce corresponding elastic deformation according to the deformation of the skin, thereby preventing the electrode from breaking or falling off, and at the same time, the electrode and the skin
  • the close fit increases the contact area between the skin and the electrode, reduces the contact impedance between the electrode and the skin, and improves the quality of collecting biological signals.
  • Step S140 making a biological signal output interface.
  • the clothing material can be cotton, silk, linen, etc.
  • the wristband type biological signal collecting device of the present invention can collect various types of biological signals, for example, EMG and ECG. Different wristbands can be used for the collection of different types of biological signals.
  • a wristband used to separately collect EMG signals contains two pairs of microneedle electrodes that can collect two channels of EMG signals and use them for motion recognition.
  • FIG. 2 shows a wristband-type biological signal acquisition device 200 for EMG signal acquisition, which includes two pairs of electrodes and can acquire signals of two channels.
  • the device 200 includes a wristband 201 and a microneedle array 202 to illustrate the signal collection of one channel.
  • 2021 is a schematic front view of the microneedle electrode
  • the inner circle of the concentric circle is the microneedle chassis
  • 2022 is the side of the microneedle. See schematic diagram.
  • the bipolar limb I lead method is used to collect ECG signals, and the user needs to wear a wristband-type device on the left and right arms. Therefore, the wristband used for ECG signal collection alone is shown in Figure 3.
  • the wristband-type device contains an electrode (or a microneedle array), and the left and right wrists each wear a wristband when collecting ECG signals, and the rest are the same as in Figure 2.
  • 301 is a wristband.
  • 302 is a microneedle array electrode in one of the channels.
  • 303 is a biological signal output interface, and the wristband is fixed on the arm.
  • 3021 is the front view of the microneedle electrode, and the inner circle of the concentric circle is the microneedle chassis.
  • 3022 is the side view of the microneedle. It should be understood that the two types of wristbands shown in Figures 2 and 3 can also be used at the same time.
  • the design of the microneedle array can change the size and shape of the electrode and the arrangement of the microneedle array according to the needs of use.
  • the number of electrode channels included in the wristband, the arrangement of electrode pairs of different channels, etc. can be changed according to needs. change.
  • the present invention also provides a biological signal acquisition and analysis method, which can further analyze and process various types of collected biological signals.
  • the data analysis process adopted in the present invention is shown in FIG. 4.
  • the EMG signal first use a 200-order zero phase shift FIR filter with a passband frequency of 5Hz to 450Hz to filter to reduce low-frequency interference and high-frequency noise caused by the acquisition system or motion; then use 50Hz notch Filter to reduce power frequency interference; finally, based on 5 characteristics (respectively: simple square integral (simple square integral, SSI), wavelength (wavelength, WL), fourth-order auto-regressive coefficients (auto-regressive cofficients, AR4), inflection point (turning, Turn), willison amplitude (willison amplitude, WAMP)) linear discriminant algorithm (LDA), recognizes various hands such as fisting, hand opening, wrist flexion, wrist abduction, forearm pronation and forearm supination Part action; for the ECG signal, first use a 200-order zero-phase-shift FIR filter with a passband frequency
  • the wristband-type biological signal acquisition device and acquisition method provided by the present invention are simple and convenient to use, and do not need to use conductive gel and tape; it can collect EMG signals when stationary and in motion, and can collect stationary and living ECG signals when walking in different terrains (flat ground, slopes, stairs, etc.) in the environment; it can overcome the changes in the impedance of the traditional electrode-skin contact interface with time, ambient temperature and humidity, and overcome the contact between the electrode and the skin caused by movement, pulling, etc. Poorly introduces noise; the provided wristband type microneedle array electrode uses FPC as the substrate of the microneedle array electrode, and is combined with a material that is safe and comfortable to the skin to form a wristband. You only need to wear the corresponding wristband when using it. can.
  • the Ag/AgCl electrode needs to use a conductive gel to reduce the impedance (EII) of the contact interface between the electrode and the skin and fix it with medical tape.
  • EII impedance
  • the state of the hydrogel will vary. Time, environmental temperature and humidity changes cause EII to increase, so it is not suitable for long-term monitoring of biological signals; on the other hand, conductive gel and tape can cause damage to some users with sensitive skin, which limits the use of electrodes.
  • the microneedles of the microneedle array electrode can pierce the stratum corneum to reduce EII, without the need for conductive gel, and because of the design of the wristband, there is no need to use tape to fix the electrode, thus overcoming the existing Ag/AgCl electrode Existing problems.
  • the Ag/AgCl electrode is disposable, which increases the use cost, and the wristband type microneedle array electrode of the present invention can be used multiple times to reduce the cost. And it is simple and convenient to use, and the material of the wristband is a clothing material that is safe and comfortable to the skin, is comfortable to wear, and is more suitable for long-term signal monitoring.
  • the contact between the dry electrode and the skin is easily affected by movement and the environment, and the microneedle in the microneedle electrode of the present invention can penetrate into the skin and be in close contact with the skin, reducing movement And the influence of the environment on the signal acquisition.
  • a wristband type microneedle array electrode and a matching and The connection interface of the wireless acquisition system can be assembled with the existing wireless signal acquisition system in the laboratory to form a complete wearable biological signal acquisition system.
  • the system can collect high-quality EMG and ECG signals in stationary and moving states, as well as in daily life environments, and perform some clinically relevant data analysis on the collected signals, such as calculating RR intervals and HRV on ECG signals.
  • the analysis overcomes the limitation that the prior art can only collect ECG signals stably when the user is in a quiet state.
  • the present invention provides a wearable bioelectric signal collection device that can be used to record the user's EMG and ECG signals for a long time in a real life environment.
  • the main technology includes the production of wristband micro-needle array electrodes and the production of interfaces with wireless collection devices .
  • the technical solutions include: 1) Solve the problem of the increase in EII of the existing wet electrode due to changes in the conductive gel over time and environmental temperature and humidity. The microneedles of MAE can pierce the stratum corneum to reach the active epidermis, reducing EII 2).
  • the wearable bioelectric signal acquisition method based on the wristband biosignal acquisition device proposed in the present invention can be used to record the user's EMG and ECG signals for a long time in a real life environment; it is used to connect electrodes with existing laboratory equipment.
  • the interface of the wireless signal acquisition system can be used to record the user's EMG and ECG signals for a long time in a real life environment; it is used to connect electrodes with existing laboratory equipment.
  • the user only needs to wear the wristband on the part to be tested, connect the acquisition system to start recording the physiological signal; the user can be at rest Recording stable and high signal-to-noise ratio EMG signals while walking or even swinging the arm; the acquisition system can be used to collect the EMG signals of the amputee in the motion state to recognize the movement intention to control the prosthesis; the user can sit, stand, Record ECG signals when walking, and when walking on different terrains such as slopes and stairs. The recorded signals can more accurately extract RR interval data for HRV analysis; users can choose to record EMG individually or simultaneously by selecting different wrist straps according to their needs.
  • the microneedle array electrode has simple process, low cost, and the substrate thickness is about 0.3mm, and different sizes, shapes, and microneedle arrangements can be designed according to requirements; for the wristband, choose a thinner ordinary sticker
  • the material worn is safe and comfortable.
  • the invention can be used for clinical and laboratory research, can save time for preparation of experimental operations, and can also be used for real-time recording of bioelectric signals in daily life environment, which is more convenient for real-time monitoring of the physical health of some elderly people living alone or people with limited mobility .
  • the impedance EII of the contact interface between the electrode and the skin was collected by the frequency sweep method when the frequency is 20Hz ⁇ 1MHz.
  • the result shows that when the scanning frequency is 20Hz ⁇ 500Hz, MAE
  • the EII of the electrode is obviously lower than that of the plate array electrode, and it is very stable, while the impedance curve of the plate array electrode has obvious jitter;
  • the scanning frequency is 100K ⁇ 1MHz, after stabilization, the impedance of the MAE electrode is slightly lower than that of the plate electrode; it proves that the plate electrode is EII is smaller and stable, and it is not easily affected by the environment.
  • the wristband type microneedle array electrode was used to collect the EMG signals of 6 kinds of hand movements in the sitting state and the motion state respectively. Compared with the flat electrode, the result shows that the wristband type biological signal acquisition device of the present invention is sitting still
  • the signal-to-noise ratio of the EMG signal collected during exercise is higher than that of the plate electrode; for the six hand movements, the recognition rate of the EMG signal collected by the present invention is higher than that of the plate electrode in both static and dynamic states; therefore, the present invention is collecting EMG
  • the signal performance is better than flat electrodes.
  • the ECG signals of sitting, standing, walking on flat ground, slopes and stairs are collected respectively, and the R peak is extracted.
  • the results show that the amplitude of the ECG signal collected by the device of the present invention is significantly higher than The amplitude of the ECG signal collected by the ordinary electrode; during exercise, the device of the present invention can still collect a stable ECG signal and accurately extract the R peak of the signal, while the signal collected by the ordinary electrode is seriously interfered by the movement and cannot be accurate Extract the R peak.

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Abstract

A wristband-type biological signal acquisition device (200) and a manufacturing method therefor. Said device comprises a wristband (201, 301), a micro-needle array (202, 3022) formed on a micro-needle array substrate, and a biological signal output interface (303), the micro-needle array (202, 3022) being fixed on the wristband (201, 301) and being in contact with the wearer's wrist skin, and the biological signal output interface (303) being connected to an electrode of the micro-needle array (202, 3022), so as to output an acquired biological signal. The wristband-type biological signal acquisition device (200) has a low cost, and is simple to use, convenient to carry, safe and comfortable, and a user can wear said device for a long time so as to continuously and stably record biological signals when the user is stationary or in motion.

Description

腕带式生物信号采集设备及其制作方法Wristband type biological signal acquisition equipment and manufacturing method thereof 技术领域Technical field
本发明涉及生物信号采集技术领域，尤其涉及一种腕带式生物信号采集设备及其制作方法。The invention relates to the technical field of biological signal acquisition, in particular to a wristband type biological signal acquisition device and a manufacturing method thereof.
背景技术Background technique
生物信号包括肌电信号(electromyography，EMG)、心电信号(electrocardiography，ECG)等的监测，是目前各种生物医学领域中用于人体健康状况和疾病早期诊断的重要手段。EMG监测可用于神经肌肉疾病的诊断、肌肉运动功能的检测以及假肢控制等方面；而通过记录ECG信号来分析心率变异性(heart rate variability，HRV)可以应用于心血管疾病(高血压、心肌梗死、心脏性猝死的预测、冠心病、充血性心力衰竭等)的诊断以及评价自主神经的功能(包括糖尿病、甲状腺功能异常、妇产科、呼吸***疾病、麻醉意外预测等)等方面。Biological signals include electromyography (EMG), electrocardiography (ECG), etc. monitoring, which is currently an important means for early diagnosis of human health and diseases in various biomedical fields. EMG monitoring can be used for the diagnosis of neuromuscular diseases, the detection of muscle motor function, and the control of prostheses; and the analysis of heart rate variability (HRV) by recording ECG signals can be applied to cardiovascular diseases (hypertension, myocardial infarction) , Prediction of sudden cardiac death, coronary heart disease, congestive heart failure, etc.) diagnosis and evaluation of autonomic nervous function (including diabetes, thyroid dysfunction, obstetrics and gynecology, respiratory disease, anesthesia accident prediction, etc.).
目前生物电信号的采集必然需要电极和采集***，但传统的生物信号采集电极是银/氯化银(Ag/AgCl)电极，需要使用导电凝胶或医用胶纸将其贴于被测皮肤表面，并通过导电凝胶渗透入角质层来降低电极与皮肤接触界面阻抗(electrode-skin interface impedance，EII)，从而采集生物电信号。导电凝胶一方面会随着时间慢慢变干而增加EII，另一方面会对一些皮肤敏感的使用者造成伤害，因此目前的Ag/AgCl湿电极都是一次性使用的，且不能用于长期监测。而干电极不需要导电凝胶，可以被用来代替湿电极，但是普通的干电极一方面因为有角质层而EII高，另一方面因为与皮肤接触不好易受运动干扰且拉扯易脱落。为了克服上述问题，2000年，英国皇家理工学院的Criss等人设计了一种微针电极阵列并用于采集脑电信号(electroencephalography，EEG)。微针电极不需要导电凝胶，可以刺穿皮肤角质层到达导电性高的活性表皮，一方面降低电极与皮肤接触界面阻抗(EII)，另一方面与皮肤接触稳定不易受环境干扰，而且使用方便，前后都不需要复杂的准备和清洁过程，因此微针阵列电极有望克服传统电 极存在的问题。At present, the collection of bioelectric signals necessarily requires electrodes and collection systems, but the traditional biosignal collection electrodes are silver/silver chloride (Ag/AgCl) electrodes, which need to be pasted on the surface of the tested skin with conductive gel or medical tape , And the conductive gel penetrates into the stratum corneum to reduce the electrode-skin interface impedance (EII), thereby collecting bioelectric signals. On the one hand, conductive gel will dry out gradually over time and increase EII, on the other hand, it will cause damage to some users with sensitive skin. Therefore, the current Ag/AgCl wet electrodes are disposable and cannot be used Long-term monitoring. Dry electrodes do not require conductive gel and can be used instead of wet electrodes. On the one hand, ordinary dry electrodes have a high EII because of the stratum corneum, and on the other hand, they are easily interfered by movement due to poor contact with the skin and tend to fall off when pulled. In order to overcome the above-mentioned problems, in 2000, Criss et al. of the Royal Institute of Technology in the United Kingdom designed a microneedle electrode array and used it to collect electroencephalography (EEG). The microneedle electrode does not require conductive gel and can pierce the stratum corneum of the skin to reach the active epidermis with high conductivity. On the one hand, it reduces the contact interface impedance (EII) of the electrode and the skin, and on the other hand, it is stable in contact with the skin and is not susceptible to environmental interference. Convenient, no complicated preparation and cleaning procedures are required before and after, so the microneedle array electrode is expected to overcome the problems of traditional electrodes.
就电极而言，现有的Ag/AgCl湿电极因导电凝胶会受环境温度、湿度变化以及时间推移的影响，且不适用于皮肤敏感者，需要合适的干电极来代替。而现有的干电极因与皮肤接触界面阻抗(EII)较大，且易受运动、拉扯等的干扰，不能实现稳定的采集生物信号。而微针阵列电极因其微针能穿透角质层到达阻抗较低的活性表皮来降低EII，并且微针电极与皮肤接触稳定，可以减轻运动等的干扰，因此有望克服上述电极存在的困难，实现长期生物信号检测。As far as the electrode is concerned, the existing Ag/AgCl wet electrode will be affected by environmental temperature, humidity changes and the passage of time due to the conductive gel, and it is not suitable for people with sensitive skin, and a suitable dry electrode is needed to replace it. However, the existing dry electrode cannot achieve stable collection of biological signals due to its large interface impedance (EII) in contact with the skin, and it is susceptible to interference from movement, pulling, and the like. The microneedle array electrode reduces EII because its microneedle can penetrate the stratum corneum to reach the active epidermis with low impedance, and the microneedle electrode is in stable contact with the skin, which can reduce the interference of movement, so it is expected to overcome the difficulties of the above-mentioned electrodes. Realize long-term biological signal detection.
对于微针阵列电极的制作，经典的光刻和蚀刻技术需要在净室中使用精密的装备且容易产生有毒废料，不方便、昂贵且不环保；激光加工的方法效率高且灵活，但是使用纯铜材料生物兼容性有待考虑，对于高密度且微小尺寸的微针，激光聚焦可能达不到；3D打印技术虽灵活但同样不适合高密度且微小尺寸的微针。现有技术只是简单的说明了可以用微针阵列电极来采集生物电信号，但是还没有完整的基于阵列电极的可穿戴***，而电极的佩戴仍然需要使用胶布等来固定，这对于一些皮肤敏感的使用者仍然是个问题。For the production of microneedle array electrodes, classic lithography and etching techniques require the use of sophisticated equipment in the clean room and are prone to produce toxic waste, which is inconvenient, expensive and environmentally unfriendly; the laser processing method is efficient and flexible, but uses pure The biocompatibility of copper materials needs to be considered. For high-density and small-sized microneedles, laser focusing may not be achieved; although 3D printing technology is flexible, it is also not suitable for high-density and small-sized microneedles. The prior art simply illustrates that microneedle array electrodes can be used to collect bioelectric signals, but there is no complete wearable system based on array electrodes, and the wearing of the electrodes still needs to be fixed with tape, etc., which is sensitive to some skins. Of users are still a problem.
发明内容Summary of the invention
本发明的目的在于克服上述现有技术的缺陷，提供一种腕带式生物信号采集设备及其制作方法，基于微阵列电极设计使用简单、携带方便、安全舒适的可穿戴设备。The purpose of the present invention is to overcome the above-mentioned defects of the prior art, and provide a wristband type biological signal acquisition device and a manufacturing method thereof, based on a microarray electrode design that is simple to use, easy to carry, safe and comfortable wearable device.
根据本发明的第一方面，提供了一种腕带式生物信号采集设备。该设备包括腕带、形成在微针阵列基底上的微针阵列、生物信号输出接口，其中，所述微针阵列固定在所述腕带上与佩戴者的腕部皮肤接触，所述生物信号输出接口与所述微针阵列电极连接以输出采集到的生物信号。According to the first aspect of the present invention, there is provided a wristband type biological signal acquisition device. The device includes a wristband, a microneedle array formed on a microneedle array substrate, and a biological signal output interface, wherein the microneedle array is fixed on the wristband and contacts the wearer's wrist skin, and the biological signal The output interface is connected with the microneedle array electrode to output the collected biological signal.
在一些实施例中，所述微针阵列基底是柔性电路板，所述微针阵列基底的导电底盘是圆形，圆形底盘直径是800um。In some embodiments, the microneedle array substrate is a flexible circuit board, the conductive chassis of the microneedle array substrate is circular, and the diameter of the circular chassis is 800um.
在一些实施例中，所述微针阵列包括多个结构相同或不同的微针。In some embodiments, the microneedle array includes a plurality of microneedles with the same or different structures.
在一些实施例中，所述微针阵列的多个微针的结构相同，每个微针是圆锥形，每个微针与所述微针阵列基底连接的底部直径是750um，针尖直径是20um，微针长度是500um～600um。In some embodiments, the multiple microneedles of the microneedle array have the same structure, each microneedle is conical, the bottom diameter of each microneedle connected to the microneedle array substrate is 750um, and the diameter of the needle tip is 20um. , The length of the microneedle is 500um～600um.
在一些实施例中，所述微针阵列的整体尺寸为8mm×5mm，所述微针 阵列的多个微针设为矩形分布的4×6微针，微针的中心间距是1mm。In some embodiments, the overall size of the microneedle array is 8 mm×5 mm, and the plurality of microneedles of the microneedle array are 4×6 microneedles distributed in a rectangular shape, and the center spacing of the microneedles is 1 mm.
在一些实施例中，所述微针阵列基底是聚酰亚胺。In some embodiments, the microneedle array substrate is polyimide.
在一些实施例中，所述微针阵列的微针材料是环氧树脂A、B溶剂和纯铁粉的混合物，其中环氧树脂A与B溶剂的体积比是3：1，环氧树脂A、B溶剂与纯铁粉的重量比是1：0.7。In some embodiments, the microneedle material of the microneedle array is a mixture of epoxy resin A, solvent B and pure iron powder, wherein the volume ratio of epoxy resin A to solvent B is 3:1, epoxy resin A , The weight ratio of B solvent to pure iron powder is 1:0.7.
在一些实施例中，在所述腕带上设置多个微针阵列，用于采集多通道的生物信号。In some embodiments, multiple microneedle arrays are provided on the wristband for collecting multi-channel biological signals.
根据本发明的第二方面，提供一种腕带式生物信号采集设备的制作方法。该方法包括：制作微针阵列的柔性基底；在柔性基底的底盘上通过磁牵引技术形成微针阵列；固化所述微针阵列，并通过磁控溅射镀膜技术在所述微针阵列表面真空溅镀一层质地均匀的金属；制作生物信号输出接口；选择衣物材料制作腕带，将制作好的微针阵列、导线、生物信号输出接口组装入腕带。According to a second aspect of the present invention, there is provided a manufacturing method of a wristband type biological signal acquisition device. The method includes: making a flexible substrate for the microneedle array; forming a microneedle array on the chassis of the flexible substrate by magnetic pulling technology; curing the microneedle array, and vacuuming the surface of the microneedle array by magnetron sputtering coating technology Sputter a layer of metal with uniform texture; make a biological signal output interface; choose clothing materials to make a wristband, and assemble the made microneedle array, wires, and biological signal output interface into the wristband.
在一些实施例中，磁控溅射参数设置为：Ti，反应气压1pa，溅射功率300W，溅射时间5S，厚5nm；Au，反应气压1pa，溅射功率200W，溅射时间60S，厚100nm。In some embodiments, the magnetron sputtering parameters are set as: Ti, reaction pressure 1pa, sputtering power 300W, sputtering time 5S, thickness 5nm; Au, reaction pressure 1pa, sputtering power 200W, sputtering time 60S, thickness 100nm.
与现有技术相比，本发明的优点在于：提供一种成本低廉、使用简单、携带方便、安全舒适的可穿戴设备，使用者可以长时间佩戴该设备持续稳定记录静止和运动时的生物信号；对于截肢用户，可以长时间穿戴该设备采集生物信号进行运动意图识别，以此配合假肢的控制，使用者不会因长时间佩戴电极而产生不适感；使用者可以在日常生活场景中穿戴该设备在静坐、站立、以及不同地形行走时记录稳定的生物信号，记录到的信号可用于HRV(心率变异性)分析等；使用者可以根据需要灵活选择不同的腕带来选择单独或同时记录不同类型的生物信号。Compared with the prior art, the present invention has the advantages of providing a low-cost, easy-to-use, easy-to-carry, safe and comfortable wearable device, and the user can wear the device for a long time and continuously and stably record biosignals at rest and in motion. ; For amputee users, you can wear the device for a long time to collect biological signals for movement intention recognition, in order to cooperate with the control of the prosthesis, the user will not feel discomfort due to wearing electrodes for a long time; the user can wear the device in daily life scenes The device records stable biological signals when sitting, standing, and walking on different terrains, and the recorded signals can be used for HRV (heart rate variability) analysis, etc.; users can flexibly choose different wristbands according to their needs to choose to record different separately or at the same time Types of biological signals.
附图说明Description of the drawings
以下附图仅对本发明作示意性的说明和解释，并不用于限定本发明的范围，其中：The following drawings only schematically illustrate and explain the present invention, and are not used to limit the scope of the present invention, in which:
图1是根据本发明一个实施例的微针阵列电极基底的示意图；Fig. 1 is a schematic diagram of a microneedle array electrode substrate according to an embodiment of the present invention;
图2是根据本发明一个实施例的用于记录肌电信号的腕带式微针阵列电极的示意图；2 is a schematic diagram of a wristband type microneedle array electrode for recording myoelectric signals according to an embodiment of the present invention;
图3是根据本发明一个实施例的用于记录心电信号的腕带式微针阵列 电极的示意图；Figure 3 is a schematic diagram of a wristband type microneedle array electrode for recording ECG signals according to an embodiment of the present invention;
图4是根据本发明一个实施例的肌电信号和心电信号的数据处理流程图。Fig. 4 is a flow chart of data processing of electromyographic signals and electrocardiographic signals according to an embodiment of the present invention.
具体实施方式Detailed ways
为了使本发明的目的、技术方案、设计方法及优点更加清楚明了，以下结合附图通过具体实施例对本发明进一步详细说明。应当理解，此处所描述的具体实施例仅用于解释本发明，并不用于限定本发明。In order to make the objectives, technical solutions, design methods, and advantages of the present invention clearer, the present invention will be further described in detail below through specific embodiments with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are only used to explain the present invention, but not used to limit the present invention.
在本文示出和讨论的所有例子中，任何具体值应被解释为仅仅是示例性的，而不是作为限制。因此，示例性实施例的其它例子可以具有不同的值。In all examples shown and discussed herein, any specific value should be construed as merely exemplary, rather than as a limitation. Therefore, other examples of the exemplary embodiment may have different values.
对于相关领域普通技术人员已知的技术、方法和设备可能不作详细讨论，但在适当情况下，所述技术、方法和设备应当被视为说明书的一部分。The technologies, methods, and equipment known to those of ordinary skill in the relevant fields may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be regarded as part of the specification.
本发明提供一种成本低廉、使用简单、携带方便、安全舒适的可穿戴腕带式微针阵列电极的生物信号采集设备，可用于在日常生活环境中长期监测生物电信号，例如EMG和ECG。The invention provides a biosignal acquisition device with a wearable wristband type microneedle array electrode that is low in cost, simple to use, convenient to carry, safe and comfortable, and can be used for long-term monitoring of bioelectric signals in daily life environments, such as EMG and ECG.
参见图1所示的微针阵列电极基底，其中整块电极片100包括24个微针电极，单个微针电极的底盘标记为101、电极基底102，并示出了电极与信号采集设备接口103，在本文中也称为生物信号输出接口103。Referring to the microneedle array electrode substrate shown in FIG. 1, the whole electrode sheet 100 includes 24 microneedle electrodes. The chassis of a single microneedle electrode is labeled 101, the electrode substrate 102, and the electrode and signal acquisition device interface 103 is shown. , Is also referred to as the biological signal output interface 103 herein.
电极底盘101可采用金属材料，例如铜；电极基底102可采用柔性电路板材料加工，例如，聚酰亚胺；生物信号输出接口103用于将采集的信号传送至外部的数据处理设备(例如计算机)，可采用有线方式或无线方式与数据处理设备或现有的无线数据采集***通信，生物信号输出接口103与微针电极可通过导线电连接(未示出)。The electrode chassis 101 can be made of metal materials, such as copper; the electrode substrate 102 can be made of flexible circuit board materials, such as polyimide; the biological signal output interface 103 is used to transmit the collected signals to an external data processing device (such as a computer). ), the data processing equipment or the existing wireless data acquisition system can be communicated in a wired or wireless manner, and the biosignal output interface 103 and the microneedle electrode can be electrically connected through a wire (not shown).
结合图1，可根据以下步骤制作腕带式生物信号采集设备：Combined with Figure 1, a wristband-type biosignal acquisition device can be made according to the following steps:
步骤S110，确定微针电极的参数。Step S110: Determine the parameters of the microneedle electrode.
微针电极需要有合适的长径比。根据人体皮肤表面的结构，由外至内依次为表皮、真皮和皮下组织。表皮包括角质层和活性表皮，角质层由角化细胞组成，厚度约为15um～20um，具有很高的阻抗，而活性表皮厚度约为200um，具有较高的导电性；而真皮层则分布有血管、感受器等。如果微针刺入皮肤的真皮层则会导致疼痛并可能造成伤害。基于上述的人体皮肤表面结构，微针的刺入深度设置在20um～200um之间，因为皮肤是柔软 的，导致微针不可能全部刺入皮肤，在本发明实施例中，将微针的长度设置为500um～600um，从而保证微针能够刺穿角质层但不会导致皮肤损伤。The microneedle electrode needs to have a proper aspect ratio. According to the structure of the human skin surface, from the outside to the inside, it is the epidermis, dermis and subcutaneous tissue. The epidermis includes the stratum corneum and the active epidermis. The stratum corneum is composed of keratinocytes, with a thickness of about 15um to 20um, and has high impedance, while the thickness of the active epidermis is about 200um, which has high conductivity; while the dermis is distributed with Blood vessels, receptors, etc. If the microneedles penetrate the dermis of the skin, it will cause pain and possibly injury. Based on the above-mentioned human skin surface structure, the penetration depth of the microneedles is set between 20um and 200um. Because the skin is soft, it is impossible for the microneedles to penetrate the skin completely. In the embodiment of the present invention, the length of the microneedles is reduced It is set to 500um～600um to ensure that the microneedle can penetrate the stratum corneum without causing skin damage.
在一个实施例中，将微针设置为圆锥形，底部直径约750um，针尖直径约20um。In one embodiment, the microneedle is set in a conical shape, the diameter of the bottom is about 750um, and the diameter of the needle tip is about 20um.
在一个实施例中，一个微针阵列电极整体尺寸约为8mm×5mm，由矩形分布的4×6共24个微针组成，微针的中心间距为1mm。这种设置能够保证微针电极和皮肤足够的接触面积，也保证了电极尺寸不会太大。相邻的微针电极的中心距的限定不仅保证了合适的电极尺寸，又保证了对皮肤的微创，不会由于过小的中心距而造成针孔过密。In one embodiment, the overall size of a microneedle array electrode is about 8mm×5mm, and it is composed of 24 microneedles in a rectangular distribution of 4×6, and the center spacing of the microneedles is 1 mm. This arrangement can ensure a sufficient contact area between the microneedle electrode and the skin, and also ensure that the size of the electrode is not too large. The limitation of the center distance of adjacent microneedle electrodes not only ensures a suitable electrode size, but also ensures minimally invasive skin, and does not cause too small center distances to cause pinholes to be too dense.
应理解的是，微针电极阵列的阵列规模、微针高度、微针直径等参数灵活可调，各微针的结构可以相同或不相同，例如，根据微针阵列与皮肤的贴合程度，可以设置高度不同的微针。It should be understood that the array scale, microneedle height, microneedle diameter and other parameters of the microneedle electrode array are flexibly adjustable, and the structure of each microneedle can be the same or different. For example, according to the degree of adhesion of the microneedle array to the skin, Microneedles with different heights can be set.
步骤S120，制作电极的基底。In step S120, a substrate of the electrode is fabricated.
例如，使用Altium Designer14软件绘制PCB原理图(如图1所示)，然后加工基底。基底可以以耐热性高、尺寸稳定性好的聚酰亚胺为主，设计轻而薄、有很好的弯折性、布线密度较大时能较好地贴合于人体，每个微针电极的导电底盘材料为铜，圆形底盘直径为800um。For example, use Altium Designer14 software to draw a PCB schematic diagram (as shown in Figure 1), and then process the substrate. The substrate can be made of polyimide with high heat resistance and good dimensional stability. The design is light and thin, has good flexibility, and can fit the human body better when the wiring density is high. The conductive chassis material of the needle electrode is copper, and the diameter of the circular chassis is 800um.
在本发明实施例中，微针电极基底为聚亚酰胺柔性电路板，硬度既可以保证微针比较容易地刺入皮肤，同时可以很好的结合腕带并贴合皮肤。In the embodiment of the present invention, the microneedle electrode substrate is a polyimide flexible circuit board, and the hardness can ensure that the microneedle can penetrate the skin relatively easily, and at the same time, it can be well combined with the wristband and fit the skin.
步骤S130，在电极基底的底盘上拉出微针。In step S130, the microneedle is pulled out from the bottom plate of the electrode base.
可使用磁牵引的方法在基底的底盘上拉出微针，微针材料可以是硅、聚合物或金属等。例如，微针材料为环氧树脂A、B(重量比：A/B＝3/1)溶剂和纯铁粉的混合物(重量比：环氧树脂溶剂/铁粉＝1/0.7)。The magnetic traction method can be used to pull out the microneedles on the chassis of the substrate. The material of the microneedles can be silicon, polymer or metal. For example, the microneedle material is a mixture of epoxy resin A, B (weight ratio: A/B=3/1) solvent and pure iron powder (weight ratio: epoxy resin solvent/iron powder=1/0.7).
具体地，使用直径约为0.7mm的弹簧针头蘸取混合试剂滴在制备好的柔性基底的底盘上，在磁场强度约为2000高斯的磁场中拉出微针。然后，室温下将其放在磁铁中间24小时至微针完全固化，贴上掩膜板，采用磁控溅射的方法在微针上镀上一层金膜，磁控参数设置为：Ti，反应气压1pa，溅射功率300W，溅射时间5S，厚约5nm；Au，反应气压1pa，溅射功率200W，溅射时间60S，厚约100nm。Specifically, a pogo needle with a diameter of about 0.7 mm is used to dip the mixed reagent droplets on the base of the prepared flexible substrate, and the microneedles are pulled out in a magnetic field with a magnetic field strength of about 2000 Gauss. Then, place it in the middle of the magnet at room temperature for 24 hours until the microneedle is completely cured, paste the mask, and coat a layer of gold on the microneedle by magnetron sputtering. The magnetron parameter is set to Ti, The reaction pressure is 1pa, the sputtering power is 300W, the sputtering time is 5S, and the thickness is about 5nm; Au, the reaction pressure is 1pa, the sputtering power is 200W, the sputtering time is 60S, and the thickness is about 100nm.
在本发明实施例中，在柔性基底上制备出机械强度高，稳定性高的微针阵列，柔性材料可以根据皮肤的形变产生相应弹性形变，从而防止电极发生断裂或脱落，同时使电极和皮肤紧密贴合，增加了皮肤与电极的接触 面积，降低了电极和皮肤之间的接触阻抗，从而提高了采集生物信号的质量。In the embodiment of the present invention, a microneedle array with high mechanical strength and high stability is prepared on a flexible substrate. The flexible material can produce corresponding elastic deformation according to the deformation of the skin, thereby preventing the electrode from breaking or falling off, and at the same time, the electrode and the skin The close fit increases the contact area between the skin and the electrode, reduces the contact impedance between the electrode and the skin, and improves the quality of collecting biological signals.
步骤S140，制作生物信号输出接口。Step S140, making a biological signal output interface.
制作生物信号输出接口，用于与信号采集***通信(例如采用有线方式)，然后，选择舒适且对皮肤安全的衣物材料制作腕带，将制作好的微针阵列电极、导线接口等组装入腕带，形成腕带式生物信号采集设备。衣物材料可采用棉、丝绸、麻等。Make a bio-signal output interface for communication with the signal acquisition system (for example, using a wired method). Then, select a comfortable and skin-safe clothing material to make a wristband, and assemble the made microneedle array electrodes, wire interface, etc. into the wrist Belt, forming a wristband type biological signal acquisition device. The clothing material can be cotton, silk, linen, etc.
利用本发明的腕带式生物信号采集设备可采集多种类型的生物信号，例如，EMG和ECG。对于不同类型生物信号的采集可使用不同的腕带。例如，用于单独采集EMG信号的腕带里包含两对微针电极可采集两个通道的EMG信号，并用于动作识别。图2示出了用于EMG信号采集的腕带式生物信号采集设备200，其包含两对电极，可采集两个通道的信号。具体地，该设备200包括腕带201、微针阵列202示意用于采集一个通道的信号，2021为微针电极的主视示意图，同心圆的内圆是微针底盘，2022为微针的侧视示意图。The wristband type biological signal collecting device of the present invention can collect various types of biological signals, for example, EMG and ECG. Different wristbands can be used for the collection of different types of biological signals. For example, a wristband used to separately collect EMG signals contains two pairs of microneedle electrodes that can collect two channels of EMG signals and use them for motion recognition. FIG. 2 shows a wristband-type biological signal acquisition device 200 for EMG signal acquisition, which includes two pairs of electrodes and can acquire signals of two channels. Specifically, the device 200 includes a wristband 201 and a microneedle array 202 to illustrate the signal collection of one channel. 2021 is a schematic front view of the microneedle electrode, the inner circle of the concentric circle is the microneedle chassis, and 2022 is the side of the microneedle. See schematic diagram.
在一个实施例中，采用双极肢体I导联的方法采集ECG信号，使用者需要在左右手臂分别戴一只腕带式设备，因此单独用于ECG信号采集的腕带如图3所示，腕带式设备包含一块电极(或称一个微针阵列)，采集ECG信号时左右两手腕各戴一条腕带，其他同图2中一样。301为腕带。302是其中一个通道的一块微针阵列电极。303为生物信号输出接口，并将腕带固定在手臂上。3021为微针电极的主视示意，同心圆的内圆是微针底盘。3022为微针的侧视示意。应理解的是，图2和图3的这两种腕带也可以同时使用。In one embodiment, the bipolar limb I lead method is used to collect ECG signals, and the user needs to wear a wristband-type device on the left and right arms. Therefore, the wristband used for ECG signal collection alone is shown in Figure 3. The wristband-type device contains an electrode (or a microneedle array), and the left and right wrists each wear a wristband when collecting ECG signals, and the rest are the same as in Figure 2. 301 is a wristband. 302 is a microneedle array electrode in one of the channels. 303 is a biological signal output interface, and the wristband is fixed on the arm. 3021 is the front view of the microneedle electrode, and the inner circle of the concentric circle is the microneedle chassis. 3022 is the side view of the microneedle. It should be understood that the two types of wristbands shown in Figures 2 and 3 can also be used at the same time.
在实际应用中，微针阵列的设计，可以根据使用需要更改电极的尺寸、形状以及微针阵列的排布方式，腕带中包含电极通道的数目、不同通道电极对的排列等都可以根据需要更改。In practical applications, the design of the microneedle array can change the size and shape of the electrode and the arrangement of the microneedle array according to the needs of use. The number of electrode channels included in the wristband, the arrangement of electrode pairs of different channels, etc. can be changed according to needs. change.
基于本发明提供的腕带式生物信号采集设备，本发明还提供一种生物信号采集分析方法，可对采集到的多种类型的生物信号进一步分析处理。Based on the wristband type biological signal acquisition device provided by the present invention, the present invention also provides a biological signal acquisition and analysis method, which can further analyze and process various types of collected biological signals.
例如，对于采集到的EMG和ECG数据，本发明中采用的数据分析流程如图4所示。具体地，对于EMG信号，首先使用通带频率为5Hz～450Hz的200阶的零相移FIR滤波器进行滤波来消减采集***或者运动等导致的低频干扰和高频噪声；然后再用50Hz陷波器消减工频干扰；最后，通过 基于5种特征(分别为：简单平方积分(simple square integral，SSI)、波长(wavelength，WL)、4阶自回归系数(auto-regressive cofficients，AR4)、拐点(turning，Turn)、willison幅值(willison amplitude，WAMP))的线性判别算法(LDA)，识别握拳、手张开、腕内屈、腕外展、前臂旋前和前臂旋后等多种手部动作；对于ECG信号，首先使用通带频率为1Hz～35Hz的200阶的零相移FIR滤波器进行滤波，然后通过阈值判断的方法提取滤波后的ECG曲线上的R峰值，得到R-R间隔数据，从而分析心率变异性(HRV)，计算HRV的时域和频域指标：全部窦性心搏R-R间期的标准差(SDNN，ms)、R-R间期平均值的标准差(SDANN，ms)、相邻R-R间期差值的均方根(RMSSD，ms)、总功率(≤0.4Hz，TP/ms 2)、极低频率范围功率(≤0.04Hz，VLFP/ms 2)、低频范围功率(0.04～0.15Hz，LFP/ms 2)、高频范围功率(0.15～0.4Hz，HFP/ms 2)。 For example, for the collected EMG and ECG data, the data analysis process adopted in the present invention is shown in FIG. 4. Specifically, for the EMG signal, first use a 200-order zero phase shift FIR filter with a passband frequency of 5Hz to 450Hz to filter to reduce low-frequency interference and high-frequency noise caused by the acquisition system or motion; then use 50Hz notch Filter to reduce power frequency interference; finally, based on 5 characteristics (respectively: simple square integral (simple square integral, SSI), wavelength (wavelength, WL), fourth-order auto-regressive coefficients (auto-regressive cofficients, AR4), inflection point (turning, Turn), willison amplitude (willison amplitude, WAMP)) linear discriminant algorithm (LDA), recognizes various hands such as fisting, hand opening, wrist flexion, wrist abduction, forearm pronation and forearm supination Part action; for the ECG signal, first use a 200-order zero-phase-shift FIR filter with a passband frequency of 1Hz～35Hz to filter, and then extract the R peak value on the filtered ECG curve through the threshold judgment method to obtain the RR interval data Analyze heart rate variability (HRV) and calculate HRV time-domain and frequency-domain indicators: standard deviation of all sinus heartbeat RR intervals (SDNN, ms), standard deviation of RR interval averages (SDANN, ms), phase Root mean square (RMSSD, ms) of the difference between adjacent RR intervals, total power (≤0.4Hz, TP/ms 2 ), very low frequency range power (≤0.04Hz, VLFP/ms 2 ), low frequency range power (0.04 ～0.15Hz, LFP/ms 2 ), high frequency range power (0.15～0.4Hz, HFP/ms 2 ).
综上所述，本发明的提供的腕带式生物信号采集设备和采集方法，使用简单方便，不需要使用导电凝胶和胶布；能够在静止和运动时采集EMG信号，能够采集静止以及在生活环境中不同地形(平地、斜坡、楼梯等)行走时的ECG信号；能够克服传统电极与皮肤接触界面阻抗随时间、环境温度和湿度等的变化，克服因运动、拉扯等导致的电极与皮肤接触不良引入噪声；所提供的腕带式微针阵列电极，使用FPC作为微针阵列电极的基底，并与对皮肤安全且穿戴舒适的材料共同组合成腕带，使用时只需佩戴相应的腕带即可。In summary, the wristband-type biological signal acquisition device and acquisition method provided by the present invention are simple and convenient to use, and do not need to use conductive gel and tape; it can collect EMG signals when stationary and in motion, and can collect stationary and living ECG signals when walking in different terrains (flat ground, slopes, stairs, etc.) in the environment; it can overcome the changes in the impedance of the traditional electrode-skin contact interface with time, ambient temperature and humidity, and overcome the contact between the electrode and the skin caused by movement, pulling, etc. Poorly introduces noise; the provided wristband type microneedle array electrode uses FPC as the substrate of the microneedle array electrode, and is combined with a material that is safe and comfortable to the skin to form a wristband. You only need to wear the corresponding wristband when using it. can.
与现有技术相比，本发明的优点有：Compared with the prior art, the advantages of the present invention are:
(1)、与现有标准的Ag/AgCl电极相比，Ag/AgCl电极需要使用导电凝胶降低电极与皮肤接触界面的阻抗(EII)并使用医用胶布固定，一方面水凝胶状态会随时间、环境温度和湿度变化，导致EII增加，因此不适用于长期监测生物信号；另一方面导电凝胶和胶布会对一些皮肤敏感的使用者造成伤害，这限制了电极的使用对象。而本发明中，微针阵列电极的微针可以刺穿角质层降低EII，不需要导电凝胶，而且因为腕带的设计，不需要用胶带来固定电极，因此克服了现有Ag/AgCl电极存在的问题。(1) Compared with the existing standard Ag/AgCl electrode, the Ag/AgCl electrode needs to use a conductive gel to reduce the impedance (EII) of the contact interface between the electrode and the skin and fix it with medical tape. On the one hand, the state of the hydrogel will vary. Time, environmental temperature and humidity changes cause EII to increase, so it is not suitable for long-term monitoring of biological signals; on the other hand, conductive gel and tape can cause damage to some users with sensitive skin, which limits the use of electrodes. In the present invention, the microneedles of the microneedle array electrode can pierce the stratum corneum to reduce EII, without the need for conductive gel, and because of the design of the wristband, there is no need to use tape to fix the electrode, thus overcoming the existing Ag/AgCl electrode Existing problems.
(2)、与现有标准的Ag/AgCl电极相比，Ag/AgCl电极是一次性使用的，这增加了使用成本，而本发明的腕带式微针阵列电极可以多次使用，降低成本，且使用起来简单方便，而且腕带的材料为对皮肤安全且舒适度好的衣物材料，穿戴舒适，更适用于信号的长期监测。(2) Compared with the existing standard Ag/AgCl electrode, the Ag/AgCl electrode is disposable, which increases the use cost, and the wristband type microneedle array electrode of the present invention can be used multiple times to reduce the cost. And it is simple and convenient to use, and the material of the wristband is a clothing material that is safe and comfortable to the skin, is comfortable to wear, and is more suitable for long-term signal monitoring.
(3)、与现有的干电极相比，干电极与皮肤接触易受运动、环境的影响，而本发明的微针电极中的微针能够刺入皮肤而与皮肤紧密接触，降低了运动和环境对信号采集的影响。(3) Compared with the existing dry electrode, the contact between the dry electrode and the skin is easily affected by movement and the environment, and the microneedle in the microneedle electrode of the present invention can penetrate into the skin and be in close contact with the skin, reducing movement And the influence of the environment on the signal acquisition.
(4)、与现有微针电极相比，现有的微针电极没有完整的便携式采集***，电极仍然需要使用胶带等辅助固定，本发明中设计了腕带式微针阵列电极以及配套的与无线采集***连接的接口，可与实验室现有的无线信号采集***配套组装，形成完整的可穿戴生物信号采集***。该***可以在静止和运动状态下，以及在日常生活环境中采集高质量的EMG和ECG信号，并对采集到的信号进行一些与临床相关的数据分析，例如对ECG信号计算R-R间隔并进行HRV分析，克服了现有技术只能在使用者处于安静状态下才能稳定采集ECG信号的限制。(4) Compared with the existing microneedle electrodes, the existing microneedle electrodes do not have a complete portable collection system, and the electrodes still need to be fixed with tape or other auxiliary. In the present invention, a wristband type microneedle array electrode and a matching and The connection interface of the wireless acquisition system can be assembled with the existing wireless signal acquisition system in the laboratory to form a complete wearable biological signal acquisition system. The system can collect high-quality EMG and ECG signals in stationary and moving states, as well as in daily life environments, and perform some clinically relevant data analysis on the collected signals, such as calculating RR intervals and HRV on ECG signals The analysis overcomes the limitation that the prior art can only collect ECG signals stably when the user is in a quiet state.
本发明提供了一种可用于在现实生活环境中长期记录使用者的EMG和ECG信号的可穿戴生物电信号采集设备，主要技术包括腕带式微针阵列电极的制作和与无线采集设备接口的制作。技术方案包括：1)、解决现有的湿电极因导电凝胶随时间以及环境温度和湿度等变化而导致的EII增加的问题，MAE的微针可以刺穿角质层到到达活性表皮，降低EII；2)、解决的现有的湿电极使用过程繁琐、耗时长且无法重复使用的问题，只需将腕带式MAE戴在待测部位，通过接口连接采集***即可；3)、解决现有的干电极易受运动、拉扯等干扰的问题，微针可以刺入皮肤而与皮肤稳定贴合；4)、解决目前生物信号采集只限制在实验环境中静止状态下才能稳定采集的问题，使用者可以在静止、走路甚至甩臂等状态下记录稳定且高信噪比的EMG信号，可以在日常生活环境中平地、斜坡以及楼梯等不同的地形行走时记录ECG信号。The present invention provides a wearable bioelectric signal collection device that can be used to record the user's EMG and ECG signals for a long time in a real life environment. The main technology includes the production of wristband micro-needle array electrodes and the production of interfaces with wireless collection devices . The technical solutions include: 1) Solve the problem of the increase in EII of the existing wet electrode due to changes in the conductive gel over time and environmental temperature and humidity. The microneedles of MAE can pierce the stratum corneum to reach the active epidermis, reducing EII 2). To solve the problem of cumbersome, time-consuming and unreusable use of the existing wet electrode, just wear the wristband MAE on the part to be tested and connect to the acquisition system through the interface; 3), solve the current problem Some dry electrodes are susceptible to interference from movement, pulling, etc. The microneedles can penetrate into the skin and stick to the skin stably; 4) Solve the problem that the current biological signal collection is only limited to the static state in the experimental environment. , Users can record stable and high signal-to-noise ratio EMG signals when they are stationary, walking or even swinging their arms, and can record ECG signals when walking on flat ground, slopes, stairs and other different terrains in the daily life environment.
此外，基于本发明提出的腕带式生物信号采集设备的可穿戴生物电信号采集方法，可用于在现实生活环境中长期记录使用者的EMG和ECG信号；用于连接电极与实验室现有的无线信号采集***的接口。不需要使用胶带固定、不需要使用导电凝胶、使用前不需要复杂的准备工作，使用者只需将腕带戴在待测部位，连接采集***即可开始记录生理信号；使用者可以在静止、走路甚至甩臂等状态下记录稳定且高信噪比的EMG信号；采集***可以用于采集截肢者运动状态下的EMG信号进行运动意图识别从而进行假肢控制；使用者可以在静坐、站、走路、以及斜坡、楼梯等不同的地形行走时记录ECG信号，记录到的信号可以比较准确地提取R-R 间隔数据进行HRV分析；使用者可以根据需要通过选择不同的腕带来选择单独或同时记录EMG和ECG信号；微针阵列电极工艺简单、成本低廉、基底厚度约为0.3mm，而且可以根据需求设计不同的尺寸、形状以及微针的排布等；对于腕带，选择较薄的普通可贴身穿的材料，安全舒适。本发明可用于临床、实验室研究可以节省实验操作准备时间，也可用于日常生活环境中对生物电信号的实时记录，这更便于对一些独居的老人或者行动不便者的身体健康状况进行实时监测。In addition, the wearable bioelectric signal acquisition method based on the wristband biosignal acquisition device proposed in the present invention can be used to record the user's EMG and ECG signals for a long time in a real life environment; it is used to connect electrodes with existing laboratory equipment. The interface of the wireless signal acquisition system. There is no need to use tape to fix, no need to use conductive gel, no complicated preparations before use, the user only needs to wear the wristband on the part to be tested, connect the acquisition system to start recording the physiological signal; the user can be at rest Recording stable and high signal-to-noise ratio EMG signals while walking or even swinging the arm; the acquisition system can be used to collect the EMG signals of the amputee in the motion state to recognize the movement intention to control the prosthesis; the user can sit, stand, Record ECG signals when walking, and when walking on different terrains such as slopes and stairs. The recorded signals can more accurately extract RR interval data for HRV analysis; users can choose to record EMG individually or simultaneously by selecting different wrist straps according to their needs. And ECG signals; the microneedle array electrode has simple process, low cost, and the substrate thickness is about 0.3mm, and different sizes, shapes, and microneedle arrangements can be designed according to requirements; for the wristband, choose a thinner ordinary sticker The material worn is safe and comfortable. The invention can be used for clinical and laboratory research, can save time for preparation of experimental operations, and can also be used for real-time recording of bioelectric signals in daily life environment, which is more convenient for real-time monitoring of the physical health of some elderly people living alone or people with limited mobility .
为了进一步验证本发明提供的腕带式生物信号采集设备的效果，进行了一系列实验，并制作了与微针阵列电极形状、尺寸、基底材料等除了微针以外的参数完全相同的平板阵列电极作为对比。主要验证了以下方面：In order to further verify the effect of the wristband-type biological signal acquisition device provided by the present invention, a series of experiments were carried out, and a flat-plate array electrode with the same parameters as the microneedle array electrode shape, size, substrate material, etc. except for the microneedle was produced. As a comparison. Mainly verified the following aspects:
(1)、为了验证本发明微针阵列电极的阻抗特性，通过扫频的方法采集了频率为20Hz～1MHz时，电极与皮肤接触界面的阻抗EII，结果显示扫描频率为20Hz～500Hz时，MAE电极的EII明显低于平板阵列电极，并且很稳定，而平板阵列电极阻抗曲线有很明显的抖动；扫描频率为100K～1MHz，稳定之后，MAE电极的阻抗略低于平板电极；证明平板电极的EII更小且稳定，不易受环境影响。(1) In order to verify the impedance characteristics of the microneedle array electrode of the present invention, the impedance EII of the contact interface between the electrode and the skin was collected by the frequency sweep method when the frequency is 20Hz～1MHz. The result shows that when the scanning frequency is 20Hz～500Hz, MAE The EII of the electrode is obviously lower than that of the plate array electrode, and it is very stable, while the impedance curve of the plate array electrode has obvious jitter; the scanning frequency is 100K～1MHz, after stabilization, the impedance of the MAE electrode is slightly lower than that of the plate electrode; it proves that the plate electrode is EII is smaller and stable, and it is not easily affected by the environment.
(2)、用腕带式微针阵列电极分别采集了静坐和运动状态下完成6种手部动作时的EMG信号，与平板电极比较，结果表明：本发明的腕带式生物信号采集设备在静坐和运动时采集到EMG信号的信噪比高于平板电极；对于6种手部动作，本发明采集到的EMG信号在静态和动态时的识别率都高于平板电极；因此本发明在采集EMG信号的性能优于平板电极。(2) The wristband type microneedle array electrode was used to collect the EMG signals of 6 kinds of hand movements in the sitting state and the motion state respectively. Compared with the flat electrode, the result shows that the wristband type biological signal acquisition device of the present invention is sitting still The signal-to-noise ratio of the EMG signal collected during exercise is higher than that of the plate electrode; for the six hand movements, the recognition rate of the EMG signal collected by the present invention is higher than that of the plate electrode in both static and dynamic states; therefore, the present invention is collecting EMG The signal performance is better than flat electrodes.
(3)、使用本发明的设备分别采集了静坐、站立、在平地、斜坡和楼梯行走时的ECG信号，并提取R峰，结果表明：本发明设备采集到的ECG信号的幅值明显高于普通电极采集到的ECG信号的幅值；在运动过程中，本发明的设备仍能采集到稳定的ECG信号并准确地提取信号的R峰，而普通电极采集的信号受运动干扰严重，无法准确提取R峰。(3) Using the device of the present invention, the ECG signals of sitting, standing, walking on flat ground, slopes and stairs are collected respectively, and the R peak is extracted. The results show that the amplitude of the ECG signal collected by the device of the present invention is significantly higher than The amplitude of the ECG signal collected by the ordinary electrode; during exercise, the device of the present invention can still collect a stable ECG signal and accurately extract the R peak of the signal, while the signal collected by the ordinary electrode is seriously interfered by the movement and cannot be accurate Extract the R peak.
以上已经描述了本发明的各实施例，上述说明是示例性的，并非穷尽性的，并且也不限于所披露的各实施例。在不偏离所说明的各实施例的范围和精神的情况下，对于本技术领域的普通技术人员来说许多修改和变更都是显而易见的。本文中所用术语的选择，旨在最好地解释各实施例的原理、实际应用或对市场中的技术改进，或者使本技术领域的其它普通技术人员能理解本文披露的各实施例。The embodiments of the present invention have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Without departing from the scope and spirit of the described embodiments, many modifications and changes are obvious to those of ordinary skill in the art. The choice of terms used herein is intended to best explain the principles, practical applications, or technical improvements in the market of the various embodiments, or to enable other ordinary skilled in the art to understand the various embodiments disclosed herein.

Claims (10)

  1. 一种腕带式生物信号采集设备，其特征在于，包括腕带、形成在微针阵列基底上的微针阵列、生物信号输出接口，其中，所述微针阵列固定在所述腕带上与佩戴者的腕部皮肤接触，所述生物信号输出接口与所述微针阵列电极连接以输出采集到的生物信号。A wristband type biological signal acquisition device, which is characterized by comprising a wristband, a microneedle array formed on a microneedle array substrate, and a biological signal output interface, wherein the microneedle array is fixed on the wristband and The skin of the wearer's wrist is in contact, and the biosignal output interface is connected with the microneedle array electrode to output the collected biosignal.
  2. 根据权利要求1所述的腕带式生物信号采集设备，其特征在于，所述微针阵列基底是柔性电路板，所述微针阵列基底的导电底盘是圆形，圆形底盘直径是800um。The wristband type biological signal acquisition device according to claim 1, wherein the microneedle array substrate is a flexible circuit board, the conductive chassis of the microneedle array substrate is circular, and the diameter of the circular chassis is 800um.
  3. 根据权利要求1所述的腕带式生物信号采集设备，其特征在于，所述微针阵列包括多个结构相同或不同的微针。The wristband type biological signal acquisition device according to claim 1, wherein the microneedle array comprises a plurality of microneedles with the same or different structures.
  4. 根据权利要求3所述的腕带式生物信号采集设备，其特征在于，所述微针阵列的多个微针的结构相同，每个微针是圆锥形，每个微针与所述微针阵列基底连接的底部直径是750um，针尖直径是20um，微针长度是500um～600um。The wristband type biological signal acquisition device according to claim 3, wherein the multiple microneedles of the microneedle array have the same structure, each microneedle is conical, and each microneedle is connected to the microneedle. The diameter of the bottom of the array substrate connection is 750um, the diameter of the needle tip is 20um, and the length of the microneedle is 500um-600um.
  5. 根据权利要求3所述的腕带式生物信号采集设备，其特征在于，所述微针阵列的整体尺寸为8mm×5mm，所述微针阵列的多个微针设为矩形分布的4×6微针，微针的中心间距是1mm。The wristband type biological signal acquisition device according to claim 3, wherein the overall size of the microneedle array is 8mm×5mm, and the plurality of microneedles of the microneedle array are arranged in a rectangular distribution of 4×6. Microneedles, the center spacing of the microneedles is 1mm.
  6. 根据权利要求1所述的腕带式生物信号采集设备，其特征在于，所述微针阵列基底是聚酰亚胺。The wristband type biological signal acquisition device according to claim 1, wherein the microneedle array substrate is polyimide.
  7. 根据权利要求1所述的腕带式生物信号采集设备，其特征在于，所述微针阵列的微针材料是环氧树脂A、B溶剂和纯铁粉的混合物，其中环氧树脂A与B溶剂的体积比是3：1，环氧树脂A、B溶剂与纯铁粉的重量比是1：0.7。The wristband type biological signal acquisition device according to claim 1, wherein the microneedle material of the microneedle array is a mixture of epoxy resin A, B solvent and pure iron powder, wherein epoxy resin A and B The volume ratio of solvent is 3:1, and the weight ratio of epoxy resin A, B solvent and pure iron powder is 1:0.7.
  8. 根据权利要求1所述的腕带式生物信号采集设备，其特征在于，在所述腕带上设置多个微针阵列，用于采集多通道的生物信号。The wristband type biological signal acquisition device according to claim 1, wherein a plurality of microneedle arrays are provided on the wristband for collecting multi-channel biological signals.
  9. 一种腕带式生物信号采集设备的制作方法，包括：A manufacturing method of wristband type biological signal acquisition equipment, including:
    制作微针阵列的柔性基底；Fabrication of flexible substrates for microneedle arrays;
    在柔性基底的底盘上通过磁牵引技术形成微针阵列；The microneedle array is formed on the chassis of the flexible substrate by magnetic traction technology;
    固化所述微针阵列，并通过磁控溅射镀膜技术在所述微针阵列表面真空溅镀一层质地均匀的金属；Curing the microneedle array, and vacuum sputtering a layer of metal with uniform texture on the surface of the microneedle array by magnetron sputtering coating technology;
    制作生物信号输出接口；Make biological signal output interface;
    选择衣物材料制作腕带，将制作好的微针阵列、导线、生物信号输出接口组装入腕带。Choose clothing materials to make the wristband, and assemble the prepared microneedle array, wires, and biological signal output interface into the wristband.
  10. 根据权利要求9所述的腕带式生物信号采集设备的制作方法，其中，磁控溅射参数设置为：Ti，反应气压1pa，溅射功率300W，溅射时间5S，厚5nm；Au，反应气压1pa，溅射功率200W，溅射时间60S，厚100nm。The manufacturing method of the wristband type biological signal acquisition device according to claim 9, wherein the magnetron sputtering parameters are set as: Ti, reaction pressure 1pa, sputtering power 300W, sputtering time 5S, thickness 5nm; Au, reaction The pressure is 1pa, the sputtering power is 200W, the sputtering time is 60S, and the thickness is 100nm.
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