CN110811598A

CN110811598A - Wrist strap type biological signal acquisition equipment and manufacturing method thereof

Info

Publication number: CN110811598A
Application number: CN201911112014.1A
Authority: CN
Inventors: 王迎英; 方鹏; 田岚; 李向新; 李光林
Original assignee: Shenzhen Institute of Advanced Technology of CAS
Current assignee: Shenzhen Institute of Advanced Technology of CAS
Priority date: 2019-11-14
Filing date: 2019-11-14
Publication date: 2020-02-21
Also published as: WO2021093789A1

Abstract

The invention provides a wrist strap type biological signal acquisition device and a manufacturing method thereof. The device comprises a wrist strap, a micro-needle array formed on a micro-needle array substrate and a biological signal output interface, wherein the micro-needle array is fixed on the wrist strap and is in contact with wrist skin of a wearer, and the biological signal output interface is connected with the micro-needle array electrode to output collected biological signals. The wrist strap type biological signal acquisition equipment provided by the invention has the advantages of low cost, simple use, convenience in carrying, safety and comfort, and a user can wear the equipment for a long time to continuously and stably record the biological signals in the static state and the motion state.

Description

Wrist strap type biological signal acquisition equipment and manufacturing method thereof

Technical Field

The invention relates to the technical field of biological signal acquisition, in particular to a wrist strap type biological signal acquisition device and a manufacturing method thereof.

Background

Monitoring of biological signals including Electromyography (EMG), Electrocardiography (ECG), etc., is an important means for early diagnosis of human health and diseases in various biomedical fields. EMG monitoring can be used for diagnosing neuromuscular diseases, detecting motor functions, controlling artificial limbs and the like; whereas, the analysis of the Heart Rate Variability (HRV) by recording ECG signals can be applied to diagnosis of cardiovascular diseases (hypertension, myocardial infarction, sudden cardiac death prediction, coronary heart disease, congestive heart failure, etc.) and evaluation of autonomic nerve functions (including diabetes, thyroid dysfunction, obstetrics and gynecology, respiratory diseases, anesthesia accident prediction, etc.).

At present, an electrode and an acquisition system are necessarily required for acquiring a bioelectric signal, but a traditional bioelectric signal acquisition electrode is a silver/silver chloride (Ag/AgCl) electrode, and is required to be attached to the surface of a skin to be detected by using a conductive gel or medical adhesive paper, and the conductive gel penetrates into a stratum corneum to reduce the interface impedance (EII) between the electrode and the skin, so as to acquire the bioelectric signal. Conductive gels on the one hand tend to increase EII as they dry slowly over time and on the other hand tend to cause injury to some skin sensitive users, so current Ag/AgCl wet electrodes are disposable and cannot be used for long term monitoring. Whereas dry electrodes, which do not require a conductive gel, can be used instead of wet electrodes, but ordinary dry electrodes have a high EII on the one hand due to the horny layer and on the other hand are prone to movement disturbances and to falling off by pulling because of poor contact with the skin. To overcome the above problems, in 2000, Criss et al, royal academy of technology, uk, designed a microneedle electrode array and used to collect electroencephalogram (EEG). The micro-needle electrode does not need conductive gel, can pierce the stratum corneum of the skin to reach the active epidermis with high conductivity, reduces the contact interface impedance (EII) of the electrode and the skin on the one hand, is stable and not easy to be interfered by the environment when being contacted with the skin on the other hand, is convenient to use, does not need complicated preparation and cleaning processes before and after the micro-needle electrode is used, and therefore the micro-needle array electrode is expected to overcome the problems of the traditional electrode.

As for the electrode, the existing Ag/AgCl wet electrode is affected by the environmental temperature, humidity change and time lapse due to the conductive gel, and is not suitable for the skin sensitive person, and a suitable dry electrode is required to replace. The existing dry electrode has large contact interface impedance (EII) with the skin, is easily interfered by movement, pulling and the like, and cannot realize stable acquisition of biological signals. The micro-needle array electrode can penetrate through the stratum corneum to reach the active epidermis with low impedance to reduce EII, and the micro-needle electrode is stably contacted with the skin and can reduce the interference of movement and the like, so the micro-needle array electrode is expected to overcome the difficulty of the electrode and realize long-term biological signal detection.

For the fabrication of microneedle array electrodes, classical lithography and etching techniques require the use of delicate equipment in the clean room and are prone to generate toxic waste, inconvenient, expensive and environmentally unfriendly; the laser processing method is high in efficiency and flexible, but the biocompatibility of the pure copper material needs to be considered, and the laser focusing can not be achieved for the high-density micro-sized micro-needle; 3D printing techniques, while flexible, are equally unsuitable for high density and micro-sized microneedles. The prior art simply illustrates that the micro-needle array electrode can be used for acquiring bioelectricity signals, but a complete wearable system based on the array electrode is not available, and the wearing of the electrode still needs to be fixed by using an adhesive plaster and the like, which is still a problem for some users with sensitive skin.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a wrist strap type biological signal acquisition device and a manufacturing method thereof.

According to a first aspect of the present invention, there is provided a wrist strap bio-signal acquiring device. The device comprises a wrist strap, a micro-needle array formed on a micro-needle array substrate and a biological signal output interface, wherein the micro-needle array is fixed on the wrist strap and is in contact with wrist skin of a wearer, and the biological signal output interface is connected with the micro-needle array electrode to output collected biological signals.

In some embodiments, the microneedle array substrate is a flexible circuit board, the conductive base plate of the microneedle array substrate is circular, and the diameter of the circular base plate is 800 um.

In some embodiments, the microneedle array comprises a plurality of microneedles that are the same or different in structure.

In some embodiments, the plurality of microneedles of the microneedle array have the same structure, each microneedle is conical, the diameter of the bottom of each microneedle connected with the microneedle array substrate is 750um, the diameter of the needle tip is 20um, and the length of the microneedle is 500-600 um.

In some embodiments, the microneedle array has an overall dimension of 8mm × 5mm, the plurality of microneedles of the microneedle array are configured as 4 × 6 microneedles distributed in a rectangular shape, and the center-to-center distance between the microneedles is 1 mm.

In some embodiments, the microneedle array substrate is polyimide.

In some embodiments, the microneedle material of the microneedle array is a mixture of epoxy A, B solvent and fine iron powder, wherein the volume ratio of epoxy a to B solvent is 3: 1, the weight ratio of the solvent of the epoxy resin A, B to the pure iron powder is 1: 0.7.

in some embodiments, a plurality of microneedle arrays are disposed on the wristband for acquiring multichannel bio-signals.

According to a second aspect of the present invention, there is provided a method of manufacturing a wristband type bio-signal acquiring device. The method comprises the following steps: manufacturing a flexible substrate of the microneedle array; forming a micro-needle array on a chassis of a flexible substrate by a magnetic traction technology; solidifying the microneedle array, and sputtering a layer of metal with uniform texture on the surface of the microneedle array in vacuum by a magnetron sputtering coating technology; manufacturing a biological signal output interface; clothes materials are selected to manufacture the wrist strap, and the manufactured micro-needle array, the lead and the biological signal output interface are assembled into the wrist strap.

In some embodiments, the magnetron sputtering parameters are set as: ti, the reaction pressure is 1pa, the sputtering power is 300W, the sputtering time is 5S, and the thickness is 5 nm; au, reaction pressure of 1pa, sputtering power of 200W, sputtering time of 60S and thickness of 100 nm.

Compared with the prior art, the invention has the advantages that: the wearable device is low in cost, simple to use, convenient to carry, safe and comfortable, and a user can wear the wearable device for a long time to continuously and stably record the biological signals in the static state and the motion state; for an amputation user, the device can be worn for a long time to collect biological signals for identifying the movement intention, so that the user can not feel uncomfortable due to wearing of the electrodes for a long time by matching with the control of an artificial limb; the user can wear the device in daily life scenes to record stable biological signals when sitting still, standing and walking on different terrains, and the recorded signals can be used for HRV (heart rate variability) analysis and the like; the user can flexibly select different wrist bands to record different types of biological signals independently or simultaneously according to needs.

Drawings

The invention is illustrated and described only by way of example and not by way of limitation in the scope of the invention as set forth in the following drawings, in which:

fig. 1 is a schematic view of a microneedle array electrode substrate according to one embodiment of the present invention;

fig. 2 is a schematic view of a wristband-type microneedle array electrode for recording an electromyographic signal according to an embodiment of the present invention;

FIG. 3 is a schematic diagram of a wristband-type microneedle array electrode for recording cardiac electrical signals according to one embodiment of the invention;

FIG. 4 is a flow chart of data processing of electromyographic signals and electrocardiographic signals, according to one embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions, design methods, and advantages of the present invention more apparent, the present invention will be further described in detail by specific embodiments with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not as a limitation. Thus, other examples of the exemplary embodiments may have different values.

Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate.

The wearable wrist strap type micro-needle array electrode biological signal acquisition equipment is low in cost, simple to use, convenient to carry, safe and comfortable, and can be used for monitoring biological electric signals such as EMG and ECG in daily life environments for a long time.

Referring to the microneedle array electrode substrate shown in fig. 1, wherein the monolithic electrode sheet 100 comprises 24 microneedle electrodes, the chassis of the individual microneedle electrodes is labeled 101, the electrode substrate 102, and the electrode-to-signal acquisition device interface 103, also referred to herein as the biological signal output interface 103, is shown.

The electrode chassis 101 may be made of a metal material, such as copper; the electrode substrate 102 may be fabricated using flexible circuit board materials, such as polyimide; the biological signal output interface 103 is used for transmitting the acquired signal to an external data processing device (e.g. a computer), and can be in wired or wireless communication with the data processing device or an existing wireless data acquisition system, and the biological signal output interface 103 and the microneedle electrode can be electrically connected through a lead (not shown).

With reference to fig. 1, the wristband type bio-signal acquiring device may be manufactured according to the following steps:

in step S110, parameters of the microneedle electrode are determined.

Microneedle electrodes need to have a suitable aspect ratio. According to the structure of the skin surface of a human body, the epidermis, the dermis and the subcutaneous tissue are sequentially arranged from outside to inside. The epidermis comprises a horny layer and an active epidermis, wherein the horny layer is composed of keratinocytes, the thickness of the horny layer is about 15-20 um, the horny layer has very high impedance, and the thickness of the active epidermis is about 200um, and the active epidermis has higher conductivity; blood vessels, receptors and the like are distributed in the dermis layer. The microneedles can cause pain and can cause injury if they penetrate the dermal layer of the skin. Based on the surface structure of human skin, the penetration depth of the micro-needle is set between 20um and 200um, and the micro-needle cannot penetrate into the skin because the skin is soft, and in the embodiment of the invention, the length of the micro-needle is set to be 500um to 600um, so that the micro-needle can penetrate through the stratum corneum without causing skin damage.

In one embodiment, the microneedles are configured as cones with a base diameter of about 750um and a tip diameter of about 20 um.

In one embodiment, the whole size of a microneedle array electrode is about 8mm × 5mm, and the microneedle array electrode is composed of 24 microneedles which are distributed in a rectangular shape, and the center distance of the microneedles is 1 mm. The arrangement can ensure enough 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 the adjacent microneedle electrodes not only ensures the proper electrode size, but also ensures the minimally invasive treatment to the skin, and the phenomenon that the needle holes are too dense due to the excessively small center distance is avoided.

It should be understood that parameters such as the array scale of the microneedle electrode array, the height of the microneedles, the diameter of the microneedles and the like are flexible and adjustable, and the structures of the microneedles can be the same or different, for example, microneedles with different heights can be arranged according to the fitting degree of the microneedle array and the skin.

Step S120, a substrate of the electrode is manufactured.

For example, a schematic diagram of a PCB (as shown in FIG. 1) is drawn using the Altium Designer14 software, and the substrate is then processed. The substrate can mainly use polyimide with high heat resistance and good dimensional stability, the design is light and thin, the substrate has good flexibility, the substrate can be better attached to a human body when the wiring density is higher, the conductive chassis material of each micro-needle electrode is copper, and the diameter of the circular chassis is 800 microns.

In the embodiment of the invention, the microneedle electrode substrate is the polyimide flexible circuit board, so that the hardness can ensure that the microneedle can easily penetrate into the skin, and meanwhile, the microneedle electrode substrate can be well combined with the wrist strap and attached to the skin.

In step S130, the microneedles are pulled out on the base plate of the electrode substrate.

The microneedles can be drawn out on the base plate of the substrate by using a magnetic drawing method, and the microneedle material can be silicon, polymer or metal. For example, the microneedle material is a mixture of an epoxy A, B (weight ratio: a/B3/1) solvent and pure iron powder (weight ratio: epoxy solvent/iron powder 1/0.7).

Specifically, a spring needle with a diameter of about 0.7mm was used to dip the mixed reagent drop onto a bottom plate of the prepared flexible substrate, and the microneedles were pulled out in a magnetic field with a magnetic field strength of about 2000 gauss. Then, placing the micro-needle in the middle of a magnet for 24 hours at room temperature until the micro-needle is completely cured, pasting a mask plate, and plating a layer of gold film on the micro-needle by adopting a magnetron sputtering method, wherein the magnetron parameters are set as follows: ti, the reaction pressure is 1pa, the sputtering power is 300W, the sputtering time is 5S, and the thickness is about 5 nm; au, reaction pressure 1pa, sputtering power 200W, sputtering time 60S and thickness of about 100 nm.

In the embodiment of the invention, the microneedle array with high mechanical strength and high stability is prepared on the flexible substrate, and the flexible material can generate corresponding elastic deformation according to the deformation of the skin, so that the electrode is prevented from being broken or falling off, meanwhile, the electrode is tightly attached to the skin, the contact area between the skin and the electrode is increased, the contact impedance between the electrode and the skin is reduced, and the quality of acquiring biological signals is improved.

Step S140, manufacturing a biological signal output interface.

And manufacturing a biological signal output interface for communicating with a signal acquisition system (for example, in a wired mode), then selecting comfortable and skin-safe clothes materials to manufacture the wrist strap, and assembling the manufactured micro-needle array electrode, the lead interface and the like into the wrist strap to form the wrist strap type biological signal acquisition equipment. The clothing material can be cotton, silk, hemp, etc.

Various types of bio-signals, such as EMG and ECG, can be acquired using the wrist-worn bio-signal acquiring apparatus of the present invention. Different wristbands may be used for acquisition of different types of bio-signals. For example, a wristband containing two pairs of microneedle electrodes for separately collecting EMG signals can collect EMG signals from two channels and use them for motion recognition. Fig. 2 shows a wrist-worn bio-signal acquisition device 200 for EMG signal acquisition comprising two pairs of electrodes, which can acquire signals of two channels. Specifically, the device 200 includes a wrist band 201 and a microneedle array 202 for acquiring a signal of one channel, 2021 is a schematic front view of a microneedle electrode, an inner circle of a concentric circle is a microneedle chassis, and 2022 is a schematic side view of a microneedle.

In one embodiment, the method of using bipolar limb I-lead to collect ECG signals requires a user to wear a wrist strap device on each of the left and right arms, so that the wrist strap device used for ECG signal collection alone is shown in fig. 3, and the wrist strap device includes an electrode (or a microneedle array), and a wrist strap is worn on each of the left and right arms when the ECG signals are collected, as in fig. 2. 301 is a wrist band. 302 is a piece of microneedle array electrode in one of the channels. 303 is a biological signal output interface and fixes the wrist strap on the arm. 3021 the front view of the microneedle electrode is schematic, and the inner circle of the concentric circle is the microneedle base plate. 3022 is a side view schematic of a microneedle. It should be understood that both wristbands of fig. 2 and 3 may also be used simultaneously.

In practical application, the size and shape of the electrodes and the arrangement mode of the microneedle array can be changed according to use requirements, and the number of electrode channels contained in the wrist band, the arrangement of different channel electrode pairs and the like can be changed according to requirements.

Based on the wrist strap type biological signal acquisition equipment provided by the invention, the invention also provides a biological signal acquisition and analysis method which can further analyze and process various types of acquired biological signals.

For example, for collected EMG and ECG data, the data analysis flow employed in the present invention is shown in fig. 4. Specifically, for the EMG signal, firstly, a 200-order zero phase shift FIR filter with a passband frequency of 5Hz to 450Hz is used for filtering to reduce low-frequency interference and high-frequency noise caused by an acquisition system or motion and the like; then, a 50Hz wave trap is used for reducing power frequency interference; finally, the method is based on 5 characteristics (namely, Simple Square Integration (SSI), Wavelength (WL), auto-regressive coefficients of 4 orders (AR 4), turning point (Turn), wilA Linear Discriminant Algorithm (LDA) of lison amplitude (WAMP) for recognizing various hand movements such as fist making, hand opening, wrist inflexion, wrist abduction, forearm pronation and forearm supination; for ECG signals, firstly, filtering by using a 200-order zero phase shift FIR filter with a passband frequency of 1 Hz-35 Hz, then extracting an R peak value on a filtered ECG curve by a threshold value judging method to obtain R-R interval data, so as to analyze Heart Rate Variability (HRV), and calculating time domain and frequency domain indexes of the HRV: standard deviation of all sinus heart beat R-R intervals (SDNN, ms), standard deviation of R-R interval mean (SDANN, ms), root mean square of adjacent R-R interval difference (RMSSD, ms), total power (less than or equal to 0.4Hz, TP/ms)²) Power in extremely low frequency range (less than or equal to 0.04Hz, VLFP/ms)²) Low frequency range power (0.04-0.15 Hz, LFP/ms)²) High frequency range power (0.15-0.4 Hz, HFP/ms²)。

In conclusion, the wrist strap type biological signal acquisition equipment and the wrist strap type biological signal acquisition method are simple and convenient to use, and do not need to use conductive gel and adhesive plaster; the ability to acquire EMG signals both at rest and in motion, the ability to acquire ECG signals both at rest and when walking on different terrains (level ground, slopes, stairs, etc.) in a living environment; the impedance of the contact interface of the traditional electrode and the skin can be overcome along with the change of time, environmental temperature, humidity and the like, and the noise caused by poor contact of the electrode and the skin due to movement, pulling and the like can be overcome; the wrist strap type microneedle array electrode uses the FPC as the substrate of the microneedle array electrode, and is combined with materials which are safe to skin and comfortable to wear into a wrist strap, and only corresponding wrist strap is needed to be worn during use.

Compared with the prior art, the invention has the advantages that:

(1) compared with the existing standard Ag/AgCl electrode, the Ag/AgCl electrode needs to use conductive gel to reduce the impedance (EII) of the contact interface between the electrode and the skin and is fixed by medical adhesive tape, on one hand, the EII is increased due to the change of the hydrogel state along with time, environmental temperature and humidity, and therefore, the Ag/AgCl electrode is not suitable for monitoring biological signals for a long time; on the other hand, the conductive gel and the adhesive plaster can cause injury to some users with sensitive skin, which limits the use objects of the electrode. In the invention, the micro-needle of the micro-needle array electrode can pierce the stratum corneum to reduce EII without conductive gel, and because of the design of the wrist strap, an adhesive tape is not needed for fixing the electrode, thereby overcoming the problems of the existing Ag/AgCl electrode.

(2) Compared with the existing standard Ag/AgCl electrode, the Ag/AgCl electrode is disposable, so that the use cost is increased, the wrist strap type microneedle array electrode can be used for multiple times, the cost is reduced, the wrist strap type microneedle array electrode is simple and convenient to use, and the wrist strap is made of a clothing material which is safe to the skin and good in comfort, is comfortable to wear and is more suitable for long-term signal monitoring.

(3) Compared with the existing dry electrode, the dry electrode is easily influenced by movement and environment when being contacted with the skin, and the micro-needle in the micro-needle electrode can penetrate into the skin to be tightly contacted with the skin, so that the influence of the movement and the environment on signal acquisition is reduced.

(4) Compared with the existing microneedle electrode, the existing microneedle electrode does not have a complete portable acquisition system, the electrode still needs to be fixed by using an adhesive tape and the like in an auxiliary mode, and the wrist strap type microneedle array electrode and the matched interface connected with the wireless acquisition system are designed in the invention, so that the wrist strap type microneedle array electrode can be assembled with the existing wireless signal acquisition system in a laboratory in a matched mode to form a complete wearable biological signal acquisition system. The system can collect high-quality EMG and ECG signals in static and moving states and in daily life environments, and perform some clinically relevant data analysis on the collected signals, such as calculating R-R intervals on the ECG signals and performing HRV analysis, thereby overcoming the limitation that the ECG signals can only be stably collected when a user is in a resting state in the prior art.

The invention provides wearable bioelectric signal acquisition equipment capable of recording EMG and ECG signals of a user for a long time in a real life environment. The technical scheme comprises the following steps: 1) the problem that the EII of the existing wet electrode is increased due to the changes of the conductive gel along with time, environmental temperature, humidity and the like is solved, and the micro-needle of the MAE can pierce through the stratum corneum to reach the active epidermis to reduce the EII; 2) the problems that the existing wet electrode is complicated in use process, long in time consumption and incapable of being used repeatedly are solved by only wearing the wrist strap type MAE on the part to be measured and connecting the acquisition system through an interface; 3) the problem that the existing dry electrode is easily interfered by movement, pulling and the like is solved, and the micro-needle can penetrate into the skin to be stably attached to the skin; 4) the problem of present biosignal collection only restrict can stabilize the collection under the quiescent condition in experimental environment is solved, the user can be at the rest, walk and get rid of the EMG signal of stable and high SNR of record under the state such as arm even, can record ECG signal when walking in different topography such as level land, slope and stair in daily life environment.

In addition, the wearable bioelectric signal acquisition method based on the wrist strap type bioelectric signal acquisition equipment can be used for recording EMG and ECG signals of a user in a real life environment for a long time; an interface for connecting the electrode to an existing wireless signal acquisition system in a laboratory. The wrist strap is not required to be fixed by using an adhesive tape, conductive gel is not required to be used, complex preparation work is not required before the wrist strap is used, and a user only needs to wear the wrist strap on the part to be detected and connect an acquisition system to start recording physiological signals; the user can record stable EMG signals with high signal-to-noise ratio in the states of static, walking and even arm swinging; the acquisition system can be used for acquiring EMG signals of the amputee in the motion state to identify the motion intention so as to control the artificial limb; the user can record ECG signals when sitting still, standing, walking on different terrains such as slopes and stairs, and the recorded signals can accurately extract R-R interval data for HRV analysis; the user can select to record the EMG and ECG signals independently or simultaneously by selecting different wrist straps according to the requirement; the microneedle array electrode has simple process and low cost, the thickness of the substrate is about 0.3mm, and different sizes, shapes, arrangement of microneedles and the like can be designed according to requirements; for the wrist strap, a thinner common body-attachable material is selected, so that the wrist strap is safe and comfortable. The invention can be used for clinical and laboratory research, can save the preparation time of experimental operation, and can also be used for real-time recording of bioelectric signals in daily living environment, thereby being more convenient for real-time monitoring of the body health condition of some solitary old people or people with mobility disabilities.

In order to further verify the effect of the wrist strap type biological signal acquisition equipment provided by the invention, a series of experiments are carried out, and a flat array electrode with the same shape, size, substrate material and other parameters except for the micro-needle as the micro-needle array electrode is manufactured for comparison. The following aspects are mainly verified:

(1) in order to verify the impedance characteristic of the microneedle array electrode, the impedance EII of the contact interface of the electrode and the skin is acquired by a frequency sweeping method when the frequency is 20 Hz-1 MHz, and the result shows that the EII of the MAE electrode is obviously lower than that of a flat array electrode and is very stable when the scanning frequency is 20 Hz-500 Hz, and the impedance curve of the flat array electrode has very obvious jitter; the scanning frequency is 100K-1 MHz, and after the scanning is stable, the impedance of the MAE electrode is slightly lower than that of the flat electrode; the EII of the flat electrode is proved to be smaller and stable and is not easily influenced by the environment.

(2) EMG signal when accomplishing 6 kinds of hand actions under the quiet seat and the motion state has been gathered respectively with wrist strap formula micropin array electrode, compares with flat electrode, and the result shows: the signal-to-noise ratio of EMG signals collected by the wrist strap type biological signal collecting equipment during sitting and movement is higher than that of a flat electrode; for 6 hand movements, the identification rate of the EMG signals collected by the invention in static and dynamic states is higher than that of a flat electrode; therefore, the performance of the invention in collecting EMG signals is better than that of a flat electrode.

(3) The ECG signals of sitting, standing, walking on flat ground, slope and stairs are respectively collected by using the equipment of the invention, and R peaks are extracted, and the results show that: the amplitude of the ECG signal acquired by the device is obviously higher than that of the ECG signal acquired by a common electrode; in the process of movement, the device can still acquire stable ECG signals and accurately extract the R peak of the signals, and the signals acquired by the common electrode are seriously interfered by movement and cannot accurately extract the R peak.

Having described embodiments of the present invention, the foregoing description is intended to be exemplary, not exhaustive, and not limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen in order to best explain the principles of the embodiments, the practical application, or improvements made to the technology in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. The wrist strap type biological signal acquisition equipment is characterized by comprising a wrist strap, a micro-needle array formed on a micro-needle array substrate and a biological signal output interface, wherein the micro-needle array is fixed on the wrist strap and is in contact with wrist skin of a wearer, and the biological signal output interface is connected with the micro-needle array electrode to output acquired biological signals.

2. The wristband bio-signal acquiring device according to claim 1, wherein the microneedle array substrate is a flexible circuit board, the conductive base plate of the microneedle array substrate is circular, and the diameter of the circular base plate is 800 um.

3. The wristband bio-signal acquiring device according to claim 1, wherein the micro-needle array comprises a plurality of micro-needles having the same or different structures.

4. The wristband type biosignal collecting device according to claim 3, wherein a plurality of microneedles of the microneedle array have the same structure, each microneedle is conical, the diameter of the bottom of each microneedle connected to the microneedle array substrate is 750um, the diameter of the needle tip is 20um, and the length of the microneedle is 500-600 um.

5. The wristband-type biosignal collecting device according to claim 3, wherein the microneedle array has an overall size of 8mm x 5mm, and the plurality of microneedles of the microneedle array are configured as 4 x 6 microneedles arranged in a rectangular pattern, with a center-to-center distance of the microneedles being 1 mm.

6. The wristband bio-signal acquiring device according to claim 1, wherein the microneedle array substrate is polyimide.

7. The wristband bio-signal acquiring device according to claim 1, wherein the micro-needle material of the micro-needle array is a mixture of epoxy A, B solvent and pure iron powder, wherein the volume ratio of epoxy a to B solvent is 3: 1, the weight ratio of the solvent of the epoxy resin A, B to the pure iron powder is 1: 0.7.

8. the wristband bio-signal acquiring device according to claim 1, wherein a plurality of micro-needle arrays are provided on the wristband for acquiring multi-channel bio-signals.

9. A manufacturing method of a wrist strap type biological signal acquisition device comprises the following steps:

manufacturing a flexible substrate of the microneedle array;

forming a micro-needle array on a chassis of a flexible substrate by a magnetic traction technology;

solidifying the microneedle array, and sputtering a layer of metal with uniform texture on the surface of the microneedle array in vacuum by a magnetron sputtering coating technology;

manufacturing a biological signal output interface;

clothes materials are selected to manufacture the wrist strap, and the manufactured micro-needle array, the lead and the biological signal output interface are assembled into the wrist strap.

10. The method for manufacturing a wrist strap bio-signal collection device according to claim 9, wherein magnetron sputtering parameters are set as: ti, the reaction pressure is 1pa, the sputtering power is 300W, the sputtering time is 5S, and the thickness is 5 nm; au, reaction pressure of 1pa, sputtering power of 200W, sputtering time of 60S and thickness of 100 nm.