Microneedle electrode for acquiring bio-electricity signal and equipment for acquiring bio-electricity signal

Abstract

The invention discloses a microneedle electrode capable of obtaining high-quality bioelectric digital signals and equipment for collecting bioelectric signals. According to the technical scheme, the microneedle electrode for obtaining the bio-electricity signals comprises a needle disc and a microneedle body, the microneedle body comprises a microneedle rod and a microneedle tip, a control circuit is arranged on the needle disc, and the control circuit is connected with the microneedle rod. The control circuit comprises a microprocessor, an amplifying unit, a filtering unit, an analog-to-digital converter, a power management unit and a data output unit, and the amplifying unit and the filtering unit are used for amplifying and filtering the bio-electricity signals collected by the microneedle body; the analog-to-digital converter is used for carrying out analog-to-digital conversion on the amplified and filtered bio-electricity signals to obtain digital signals, the microprocessor is used for processing various data, the power supply management unit is used for carrying out power supply management on various electronic components, and the data output unit can output the bio-electricity digital signals to the outside.

Description

Technical Field

[0001] The present invention belongs to the technical field of bioelectric signal acquisition, and in particular relates to a microneedle electrode for acquiring bioelectric signals and a device for acquiring bioelectric signals. Background Art

[0002] In the prior art, the commonly used collection electrodes for collecting human bioelectricity include wet electrodes and dry electrodes. When in use, a hydrogel electrode (wet electrode) or a metal electrode (dry electrode) is attached to the surface of the human body, and the bioelectricity is conducted from the user's body through capacitive coupling or resistive conduction. The bioelectric signal is then collected and stored through a signal collection terminal. For collection electrodes, an inevitable problem with commonly used wet electrodes or dry electrodes is that many uncontrollable factors are introduced when collecting bioelectric signals. For example, due to material limitations, such as the material properties used in wet electrodes, the electrodes cannot be made very small, which restricts their application in many scenarios. In addition, because wet electrodes or dry electrodes rely on contact with the skin to conduct electrical signals, the contact surface can easily cause irregular changes in contact impedance due to factors such as friction, movement, or sweating, which ultimately makes the collected bioelectric signals noisy and the signal quality relatively poor, affecting the quality of the collected bioelectric signals.

[0003] In order to overcome the defects of wet electrodes or dry electrodes, microneedle electrodes have also been developed in the existing technology. For the application of microneedle electrodes, we must first further understand the generation and conduction mechanism of bioelectricity. The generation of bioelectricity mainly depends on ion channels on the cell membrane, which control the flow of ions into or out of the cell. When these ion channels are open, ions flow into or out of the cell, thereby generating electrical signals. When neurons transmit signals to control muscle activity, a large number of ions will frequently enter and exit the ion channels, thereby generating a large amount of bioelectricity. The microneedles on the microneedle electrodes pierce the human epidermis to reach the dermis, and the collection of these bioelectricity can obtain the physiological signals required for medicine.

[0004] However, the inventors of this application discovered that the microneedle electrodes in the prior art, after obtaining the bioelectric signals, need to use wires to transmit the collected bioelectric signals to an external analysis device. During this wire transmission process, the process of transmitting the bioelectric signals by the wires will again increase the interference signals. Thus, after the interference signals are added to the already weak bioelectric signals, the obtained bioelectric signals are still not pure enough. Summary of the Invention

[0005] In view of the deficiencies in the prior art, the technical problem solved by the present invention is to provide a microneedle electrode capable of obtaining high-quality bioelectric digital signals and a device for collecting bioelectric signals.

[0006] In order to solve the above technical problems, the technical solution adopted by the present invention is: a microneedle electrode for obtaining bioelectric signals, comprising a needle disk and a microneedle body, the microneedle body comprising a microneedle rod and a microneedle tip, the needle disk is provided with a control circuit, the control circuit comprising a microprocessor, an amplifying unit, a filtering unit, an analog-to-digital converter, a power management unit and a data output unit, the amplifying unit and the filtering unit are used to amplify and filter the bioelectric signals collected by the microneedle body, the analog-to-digital converter is used to perform analog-to-digital conversion on the amplified and filtered bioelectric signals to obtain digital signals, the microprocessor is used to process various data, the power management unit is used to manage the power supply of various electronic components, and the data output unit can output the bioelectric digital signals to the outside.

[0007] Furthermore, the control circuit in the present technical solution further includes an infrared temperature sensor, which is arranged on an end face facing the microneedle body, and is used to measure the user's temperature.

[0008] Furthermore, the control circuit in the present technical solution also includes a distance measuring sensor, which is used to detect the distance to the user's contact part; when the temperature measured by the infrared temperature sensor is within the human body temperature range and the distance measured by the distance measuring sensor is within the set distance, other components in the control circuit start working.

[0009] Furthermore, the control circuit in the present technical solution also includes a distance measuring sensor, which is used to detect the distance from the contact part of the user; when the distance measured by the distance measuring sensor is within a set distance, other components in the control circuit start to work.

[0010] Furthermore, the control circuit in the present technical solution also includes an infrared temperature sensor, which is arranged on one end face facing the microneedle body, and is used to measure the user's temperature; when the infrared temperature sensor contacts an object and the measured temperature is within the human body temperature range, other components in the control circuit start to work.

[0011] Furthermore, in the present technical solution, a protective shell is provided on the outside of the needle tray, and at least one end surface of the protective shell facing the microneedle body is provided with medical double-sided tape.

[0012] Furthermore, the control circuit in the present technical solution also includes an acceleration sensor, which is used to detect the motion state of the microneedle electrode. When the microneedle electrode is in a motion state, the control circuit stops working or issues an alarm.

[0013] Furthermore, the metal electrode layer in the present technical solution is made of one or a combination of stainless steel, carbon steel, and platinum-iridium alloy.

[0014] The present technical solution also discloses a device for collecting bioelectric signals, which includes the microneedle electrode described in any one of the above technical solutions.

[0015] The beneficial effects brought about by the technical solution provided by the present invention are mainly: since the needle disk is provided with a control circuit, the control circuit can timely process the bioelectric signals collected by the microneedle needle body, and convert the bioelectric signals into high-quality bioelectric digital signals after filtering and amplification before transmitting them to the outside, so it can solve the problem of increased interference signals in the process of transmitting bioelectric signals by wires in the existing technology, and directly output high-quality bioelectric digital signals to external devices for use. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0017] Figure 1 is a structural stereogram of the microneedle electrode in Example 1 of the present invention;

[0018] Figure 2 This is a cross-sectional view of the structure of the microneedle electrode without the protective shell in Example 1 of the present invention;

[0019] Figure 3 yes Figure 2 Magnified view of the circled structure;

[0020] Figure 4 is a top view of the structure of the control circuit in the first embodiment of the present invention;

[0021] Figure 5 2 is a front view of the microneedle electrode in the second embodiment of the present invention;

[0022] Figure 6 This is a cross-sectional view of the structure of the microneedle electrode in Example 2 of the present invention without the protective shell;

[0023] Figure 7 yes Figure 6 Magnified view of the circled structure. DETAILED DESCRIPTION

[0024] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments and drawings. It should be understood that the specific embodiments described in this section are only used to explain the present invention and are not intended to limit the present invention.

[0025] In the description of the present invention, unless otherwise expressly specified or limited, the terms "disposed" and "connected" should be understood broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can be directly connected or indirectly connected through an intermediary. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances. For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature, as shown in the accompanying drawings.

[0026] Blood oxygen saturation (SpO2) is calculated by measuring the intensity of light attenuated by body tissue. Existing methods for measuring blood oxygen saturation primarily use transmissive and reflective methods. Transmissive methods capture more light information but require more complex acquisition design. Reflective methods, while simpler in design, capture significantly less light information and are susceptible to environmental influences, making them unsuitable for medical use.

[0027] Based on the above situation, if Figure 2 、 Figure 6 As shown, the present invention provides two preferred embodiments, hereinafter referred to as "Specific Embodiment 1 and Specific Embodiment 2." The microneedle electrodes provided in these two preferred embodiments can obtain clean bioelectrical signals and optical signals inside the measured area. Specific embodiment 1

[0029] like Figure 1 、 Figure 2 、 Figure 3As shown, a microneedle electrode 100 for acquiring bioelectric signals is disclosed. The microneedle electrode 100 includes a needle disk 110, a microneedle body 120, and a protective shell 140. The disk 110 is provided with a control circuit 130. The protective shell 140 is disposed outside the needle disk 110 to protect the needle disk 110 and the control circuit 130. The microneedle body 120 includes a microneedle shaft 121 and a microneedle tip 122. The microneedle shaft 121 includes an optical fiber 1211 and a metal electrode layer 1212 surrounding the surface of the optical fiber 1211. One end of the metal electrode layer 1212 is fixedly connected to the needle disk 110. The needle disk 110 is provided with a photosensitive element 111 for receiving the optical signal transmitted by the optical fiber 1211. In this embodiment, one end of the optical fiber 1211 is exposed outside the electrode layer 1212 to form the microneedle tip 122. That is, the microneedle tip 122 is a structure extending from one end of the optical fiber 1211. The end of optical fiber 1211 away from microneedle tip 122 is called lead-out end 1211. Lead-out end 1211 protrudes from the outer surface of needle disk 110. Photosensitive element 111 covers lead-out end 1211 to more completely receive the optical signal transmitted by optical fiber 1211. Because lead-out end 1211 protrudes from needle disk 110, optical fiber 1211 can better transmit the optical signal; and because photosensitive element 111 covers lead-out end 1211, it can better receive the optical signal transmitted by optical fiber 1211. This structural arrangement, combined with the above, facilitates obtaining high-quality optical signals, facilitating subsequent optical signal analysis and ensuring more accurate data. After passing through the epidermis and reaching the dermis, metal electrode layer 1212 can capture clean bioelectrical signals. In this embodiment, metal electrode layer 1212 is electroplated onto the surface of optical fiber 1211 using an electroplating process. The surface where metal electrode layer 1212 contacts optical fiber 1211 is designed as a mirror structure to facilitate reflection of optical signals.

[0030] In this embodiment, the control circuit 130 utilizes a flexible circuit solution. It processes the optical signals collected by the optical fiber 1211 and the bioelectric signals collected by the metal electrode layer 1212, generating high-quality optical and bioelectric digital signals. Placing the control circuit 130 on the needle disk 110 to process the received bioelectric signals reduces the interference generated by the conventional wire-based transmission of the collected bioelectric signals to the analysis device. This facilitates timely analysis of the collected optical and bioelectric signals, resulting in the transmission of high-quality bioelectric and optical digital signals.

[0031] like Figure 2 、 Figure 4As shown, the control circuit 130 includes a microprocessor 131, an amplifying unit 138, a filtering unit 139, an analog-to-digital converter 132, a power management unit 133, a data output unit 134, an infrared light emitting element 135, a red light emitting element 136 and an acceleration sensor 137. The amplifying unit 138 is used to amplify the light signal collected by the photosensitive element 111 and the bioelectric signal collected by the metal electrode layer 1212. The filtering unit 139 is used to filter the amplified light signal and bioelectric signal. The analog-to-digital converter 132 is used to filter the amplified light signal and bioelectric signal. The optical and bioelectric signals are then converted into analog-to-digital signals after filtering. A microprocessor 131 is used to control the operation of various electronic components and process various data. A power management unit 133 is used to manage the power supply to various electronic components. A data output unit 134 can output the processed optical and bioelectric digital signals. An infrared light emitting element 135 and a red light emitting element 136 are used to emit infrared and red light toward the microneedle tip 122. An accelerometer 137 is used to detect the motion state of the microneedle electrode 100. The protective housing 140 is provided with an area through which light emitted by the infrared and red light emitting elements 135 and 136 passes. This area is located at the end facing the microneedle body 120.

[0032] In this way, the high-quality optical digital signals and bioelectric digital signals output after processing by the control circuit 130 will not be afraid of the interference signals that may be added during the subsequent transmission to the analysis equipment, and will be more conducive to subsequent data analysis, that is, more accurate signals can be obtained and applied to user health monitoring, disease diagnosis and identification, disease treatment and other related work.

[0033] In this embodiment, when the microneedle electrode 100 is in motion, a signal indicating the user is in motion is generated. At this point, the microprocessor 131 controls the photosensor 111 to not collect light signals; or the amplification unit 138, filtering unit 139, and analog-to-digital converter 132 to not analyze the light signals (including infrared and red light signals) collected during the motion phase, automatically filtering out the infrared and red light signals collected during the user's motion phase; or the microprocessor 131 controls the control circuit 130 to stop operating and enter a silent state; or an alarm is issued via the data output unit 134. This design can meet the data accuracy requirements of medical equipment or special populations, ensuring more accurate measured data. The data output unit 134 can include a wired connection interface and / or a wireless transmission element. The data output unit 134 can be selected during the manufacture of the microneedle electrode 100 based on actual supporting requirements.

[0034] In this embodiment, the control circuit 130 also includes an infrared temperature sensor 1301, which is exposed outside the protective shell 140 and is located on one end surface facing the microneedle body 122. The infrared temperature sensor 1301 is used to measure the user's body temperature. When the infrared temperature sensor 1301 contacts the human body and measures an object temperature within the human body temperature range (35-42°C), the microprocessor 131 activates the other components of the control circuit 130. In other words, the control circuit 130 begins to process the optical signal collected by the optical fiber 1211 and the bioelectric signal collected by the metal electrode layer 1212, and transmits high-quality bioelectric digital signals and optical digital signals to the outside.

[0035] During operation, infrared light emitting element 135 and red light emitting element 136 emit red and infrared light onto the skin surface. The optical signal (infrared and red light information) within the skin is then transmitted to photosensor 111 via optical fiber 1211. By detecting the intensity of the infrared and red light attenuated by body tissue, the device detects the different absorption characteristics of oxygenated and reduced hemoglobin in the visible and near-infrared spectrums. Reduced hemoglobin absorbs more red-frequency light and less infrared-frequency light, while oxygenated hemoglobin absorbs less red-frequency light and more infrared-frequency light. By alternating red and infrared light irradiating the measured area, photosensor 111 (a photodiode) at output end 1211 generates a weak photocurrent that varies with the pulse. This photocurrent is converted, filtered, and amplified to produce a pulse waveform. The pulse frequency is determined from the peak spacing, and the blood oxygen saturation is determined from the ratio of the red and infrared photocurrents. This provides accurate pulse frequency and blood oxygen saturation information, enhancing the user experience.

[0036] Since the microneedle needle rod 121 includes an optical fiber 1211 and a metal electrode layer 1212, a photosensitive element 111 is provided on the needle disk 110, and the photosensitive element 111 is used to receive the light signal transmitted by the optical fiber 1211. Therefore, after the microneedle electrode 100 penetrates the user's dermis, it can not only collect the user's bioelectric information, but also obtain the light intensity change information inside the measured area through the light signal obtained by the optical fiber 1211. By analyzing the light intensity change information, the user's blood oxygen saturation, pulse rate and other physical condition information can be obtained. Specific embodiment 2

[0038] like Figure 5 、 Figure 6 、 Figure 7As shown, the main difference between the microneedle electrode 200 provided in this embodiment and the microneedle electrode 100 provided in the first embodiment lies in the different microneedle tip configuration and the addition of a distance measuring sensor 250. The microneedle tip 222 in this embodiment extends from a metal electrode layer 2212 (it is also possible to provide a separate microneedle tip connected to the metal electrode layer 2212 rather than an integrally formed structure). The end of the optical fiber 2211 near the microneedle tip 222 is coated by the metal electrode layer 2212. The metal electrode layer 2212 near the microneedle tip 222 is provided with a plurality of through-holes 2213. The coated end of the optical fiber 2211 can receive external light information through the through-holes 2213.

[0039] The distance sensor 250 is electrically connected to the control circuit 130 and is used to detect the distance between the protective case 240 and the user. In this embodiment, the microprocessor 131 controls the other components in the control circuit 130 to start operating only when the distance measured by the distance sensor 250 is within a set distance (the distance sensor 250 is in close contact with the user). In other embodiments, in combination with the first embodiment, this can be changed to the microprocessor 131 controlling the other components in the control circuit 130 to start operating only when the temperature measured by the infrared temperature sensor 1301 is within the human body temperature range and the distance measured by the distance sensor 250 is within a set distance (the distance sensor 250 is in close contact with the user).

[0040] The infrared light emitting element 135 and the red light emitting element 136 are used to emit infrared light and red light toward the plurality of through holes 2213 , so that the optical fiber 2211 can obtain external optical information through the through holes 2213 .

[0041] In this embodiment, the metal electrode layer 2212 can be made of one or a combination of stainless steel, carbon steel, and platinum-iridium alloy. The protective shell 240 is provided with medical double-sided tape 241 on at least one end facing the microneedle body 220. The medical double-sided tape 241 does not cover the area where light passes through or the detection hole of the infrared temperature sensor 1301 (not shown). Due to the provision of the medical double-sided tape 241, the microneedle electrode 200 can better maintain contact with the user, allowing the light emitted by the infrared light emitting element 135 and the red light emitting element 136 to be well directed toward the through hole 2213, allowing the optical fiber 2211 to obtain accurate optical information.

[0042] In other embodiments, since the microneedle electrodes 100, 200 are a very small component as a whole, the diameter of the needle disk 110 is about 3 mm, and the microneedle body 122 is generally about 2 mm, the control circuit 130 itself can also be an integrated chip (integrated circuit) to reduce the installation space occupied on the needle disk 110.

[0043] The microneedle electrodes 100 and 200 in the above embodiments can be used in various devices for collecting bioelectrical signals, and have far-reaching long-term application prospects. For example, these devices can be medical biomedical devices, sports monitoring devices, wearable smart devices, etc. When the microneedle electrodes 100 and 200 are used in sports monitoring devices or wearable smart devices, if the microneedle electrodes 100 and 200 are in motion, a signal indicating that the user is in motion is generated, and the photosensitive element 111 still collects light signals. Specifically, as described above, the control circuit 130 processes the light signals collected by the photosensitive element 111 in the motion state and the bioelectrical signals collected by the metal electrode layers 1212 and 2212 to obtain high-quality optical digital signals and bioelectrical digital signals. After obtaining the high-quality bioelectrical digital signals and optical digital signals, they are transmitted externally.

[0044] The above specific examples illustrate the principles and implementation methods of the present invention. It should be understood that the above implementation methods are only used to facilitate understanding of the present invention and should not be construed as limiting the present invention. For those skilled in the art, any minor improvements or equivalent substitutions made to the structural form or construction of the present invention based on the principles of the present invention should be included within the scope of its protection.

Claims

1. A microneedle electrode for acquiring bioelectric signals, comprising a needle disk and a microneedle body, wherein the microneedle body comprises a microneedle shaft and a microneedle tip, characterized in that: The needle disk is provided with a control circuit, which includes a microprocessor, an amplifying unit, a filtering unit, an analog-to-digital converter, a power management unit and a data output unit. The amplifying unit and the filtering unit are used to amplify and filter the bioelectric signals collected by the microneedle body, the analog-to-digital converter is used to perform analog-to-digital conversion on the amplified and filtered bioelectric signals to obtain digital signals, the microprocessor is used to process various data, the power management unit is used to manage the power supply of various electronic components, and the data output unit can output the bioelectric digital signals to the outside.

2. The microneedle electrode according to claim 1, characterized in that: The control circuit further includes an infrared temperature sensor, which is disposed on an end surface facing the microneedle body and is used to measure the user's temperature.

3. The microneedle electrode according to claim 2, characterized in that: The control circuit also includes a distance measuring sensor, which is used to detect the distance from the user's contact part; when the temperature measured by the infrared temperature sensor is within the human body temperature range and the distance measured by the distance measuring sensor is within the set distance, other components in the control circuit start to work.

4. The microneedle electrode according to claim 1, wherein: The control circuit further includes a distance measuring sensor, which is used to detect the distance from the contact part of the user; when the distance measured by the distance measuring sensor is within a set distance, other components in the control circuit start to work.

5. The microneedle electrode according to claim 1, wherein: The control circuit also includes an infrared temperature sensor, which is arranged on one end face facing the microneedle body and is used to measure the user's temperature; when the infrared temperature sensor contacts an object and the measured temperature is within the human body temperature range, other components in the control circuit start to work.

6. The microneedle electrode according to claim 1, wherein: A protective shell is further provided on the outside of the needle tray, and a medical double-sided tape is provided on at least one end surface of the protective shell facing the microneedle body.

7. The microneedle electrode according to claim 1, characterized in that: The control circuit further includes an acceleration sensor, which is used to detect the motion state of the microneedle electrode. When the microneedle electrode is in a motion state, the control circuit stops working or issues an alarm.

8. The microneedle electrode according to any one of claims 1 to 7, characterized in that: The microneedle body is made of stainless steel, carbon steel, platinum-iridium alloy or a combination thereof.

9. A device for collecting bioelectric signals, characterized by: It comprises the microneedle electrode according to any one of claims 1 to 8.

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