CN112617749A - Physiological and biochemical monitoring device - Google Patents
Physiological and biochemical monitoring device Download PDFInfo
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- CN112617749A CN112617749A CN202011303584.1A CN202011303584A CN112617749A CN 112617749 A CN112617749 A CN 112617749A CN 202011303584 A CN202011303584 A CN 202011303584A CN 112617749 A CN112617749 A CN 112617749A
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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
- A61B5/68—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
Abstract
The invention discloses a physiological and biochemical monitoring device, which comprises a monitoring body and a replaceable component, wherein a physiological sensor for sensing physiological sensing signals is arranged in the monitoring body, and the replaceable component can be combined on the surface of the monitoring body, so that after micro-invasion sensing is carried out towards any point on the skin of an animal body, different analyte concentrations can be obtained at the same point according to different sensing micro-needles, and biochemical sensing signals are obtained through signal conversion, therefore, the invention can simultaneously measure various physiological and biochemical signals to obtain dynamic information of the body.
Description
Technical Field
The invention relates to the technical field of physiological and biochemical monitoring, in particular to a physiological and biochemical monitoring device.
Background
In recent years, breakthroughs and quantification of various technologies have far-reaching effects on human daily life, and a wearable device can achieve movement recording and heart rhythm states, and has the effects of exercise amount recording, community interaction, heartbeat recording, sleep recording and the like.
The wearable device is usually limited to the measurement of pure physiological signals, but if the measurement of pure physiological signals (such as blood oxygen concentration, uric acid concentration or lactic acid concentration) is required, other additional devices are required to separately measure the pure physiological signals, for animal body, many signals on the body may be mutually causal, and if the physiological and biochemical signals cannot be recorded simultaneously for a long time, errors will be generated in the judgment of the condition of the animal body.
It is very important to know the continuous physical status of athletes or pilots or patients in intensive care units, but because the prior art does not have a device or apparatus capable of measuring physiological signals and biochemical signals simultaneously, it is generally impossible to control the diet content and timing, the administration content and timing, and the training content and timing more accurately, so if various physiological and biochemical signals can be measured simultaneously, the dynamic information of the body can be obtained through the fusion of the sensing signals, and the real-time adjustment and personalized adjustment of prescriptions for various health, exercise training, rehabilitation, prevention, treatment, etc. can be provided.
The traditional wearable device cannot acquire personalized physiological and biochemical information in real time, so that the calculation of big data and deep learning cannot be carried out according to the personalized physiological and biochemical information, and a medical effective prescription cannot be achieved.
Disclosure of Invention
The present invention is directed to solving, at least to some extent, one of the technical problems in the art described above. Therefore, the present invention is directed to a physiological and biochemical monitoring device, which can measure not only the physiological data of electrocardiogram, blood pressure and blood oxygen, but also the biochemical data of body surface temperature, blood sugar value, lactic acid, uric acid, cholesterol, alcohol and drug concentration, so as to measure various physiological and biochemical signals simultaneously.
To achieve the above object, an embodiment of the present invention provides a physiological and biochemical monitoring device, including:
monitoring body for combine on the animal body skin, this monitoring body is equipped with first link on the surface, and this monitoring body includes:
the power supply unit is used for providing a power supply required by the operation of the monitoring body, and an opening is arranged on the surface of the monitoring body;
the central control unit is electrically connected with the power supply unit and the first connecting end and is used for controlling the operation and data transmission of the monitoring body;
the physiological sensor is electrically connected with the power supply unit and the central control unit, is used for monitoring physiological sensing signals of the animal body and can transmit the monitored physiological sensing signals to the central control unit;
the biochemical sensor is electrically connected with the power supply unit, the central control unit and the first connecting end and is used for monitoring biochemical signals of an animal body, wherein the biochemical sensor comprises:
a detecting unit for detecting and obtaining the biochemical concentration variation value;
the processing unit is used for converting the detected biochemical concentration change value into a biochemical sensing signal and transmitting the biochemical sensing signal to the central control unit;
a replaceable component, which is combined on the surface of the monitoring body and is provided with an opening, wherein the replaceable component comprises:
the plurality of sensing microneedle sets are provided with two or more sensing microneedles, each sensing microneedle is combined with one or more sweat resisting elements, and the tips of every two or more sensing microneedles in the sensing microneedle sets can be gathered inwards;
the second connecting end is electrically connected with the first connecting end and is used for obtaining different biochemical concentration change values according to different sensing micro-needles at the same point position through the connection of the detecting unit of the biochemical sensor and the second connecting end after the micro-invasion sensing is carried out on any point of the skin of the animal body by two or more sensing micro-needles; after the replaceable component is combined on the monitoring body, the monitoring body can monitor physiological sensing signals and biochemical sensing signals simultaneously.
Further, the physiological sensor is an optical sensor, and the physiological sensor is a photoplethysmography sensor, a blood oxygen sensor or a blood pressure sensor.
Further, the physiological sensor is an electrode contact type sensor, and the physiological sensor is a body surface impedance sensor, an electrocardiogram sensor, a surface electromyogram sensor and an electroencephalogram sensor.
Furthermore, the physiological sensor is a sensor for detecting inertial motion, and the physiological sensor is a speed sensor, an acceleration sensor, an angular velocity sensor, an electronic compass, a magnetic field sensor, a multi-axis motion sensor, and is used for measuring the speed, the acceleration, the angular velocity, the azimuth angle, and the like of the motion, and can perform fusion calculation according to the speed or/and the acceleration, the angular velocity, the azimuth angle to judge the motion attitude and the trajectory.
Further, the physiological sensor is a sensor for detecting temperature, and the physiological sensor is a body surface temperature sensor.
Furthermore, the physiological and biochemical monitoring device can also be added with an environmental sensor which is not in contact with the body surface but is used for detecting environmental factors including environmental temperature, humidity, illuminance, noise, air quality and the like, and is used for deducing the influence of the change of the environmental sensing signal on the change of the physiological and biochemical signals of the wearer.
Further, the biochemical sensor is used for measuring a blood sugar value, a lactic acid value, a uric acid value, a cholesterol value, a cortisol value, an alcohol value, a gas value, an ion value, a concentration value of a medicine to be taken or two or more values.
Furthermore, the processing unit converts the detected biochemical concentration variation value into the biochemical sensing signal in an electrochemical manner.
Further, the monitoring body comprises a combination component which is used for fixing the monitoring body on the animal body so that the monitoring body can be contacted with or slightly invaded by the skin of the animal body.
Further, the sensing microneedle of the sensing microneedle is made of stainless steel, nickel alloy, titanium alloy or silicon material, or metal with biocompatibility is deposited on the surface.
Furthermore, one of the sensing microneedles in the sensing microneedle set modifies the sensing polymer and the porous protection layer on the surface.
Furthermore, the replaceable component comprises a plurality of micro-needle sheets which are overlapped, each micro-needle sheet is provided with one or more through holes, each through hole edge is provided with one or more sensing micro-needles, and after the plurality of micro-needle sheets are overlapped, a sensing micro-needle group with factor micro-needle sheets which are overlapped and penetrate out of the sensing micro-needles is formed.
Further, the replaceable component comprises:
the first microneedle sheet is used as a working electrode, is in a sheet shape, is provided with a first perforation, and is provided with a first sensing microneedle at the edge;
the second microneedle sheet is used as a reference electrode, is in a sheet shape, is provided with a second perforation, and is provided with a second sensing microneedle at the edge of the second perforation; wherein the first perforation and the second perforation are in the same vertical position, the first microneedle sheet and the second microneedle sheet are overlapped with each other, and the first sensing microneedle and the second sensing microneedle are separated from each other and are not overlapped.
Further, the replaceable component comprises:
the first microneedle sheet is used as a working electrode, is in a sheet shape, is provided with a first perforation, and is provided with a first sensing microneedle at the edge;
the second micro-needle sheet is used as a reference electrode, the second micro-needle sheet is in a sheet shape, a second perforation is arranged on the second micro-needle sheet, and a second sensing micro-needle is arranged at the edge of the second perforation;
the third microneedle sheet is used as a counter electrode and is in a sheet shape, a third perforation is arranged on the third microneedle sheet, and a third sensing microneedle is arranged at the edge of the third perforation; wherein the first perforation, the second perforation and the third perforation are vertically positioned and overlap each other, and the first sensing micro-needle, the second sensing micro-needle and the third micro-needle are separated from each other and do not overlap each other.
Furthermore, the sensing micro-needle contacts the skin and partially invades the skin, during measurement, the working electrode and the counter electrode or the reference electrode of the known micro-needle patch are respectively contacted with the skin, so that the positive electrode and the negative electrode are separated by a certain distance, when a measuring method of a constant potential rectifier is used, the sweat glands between the positive electrode and the negative electrode generate a reverse ion permeation effect (reverse ion permeation), the sweat discharge is stimulated, the concentration of the measured tissue fluid analyte and the biochemical signal thereof are influenced, and in order to reduce the effect, the sensing micro-needle is overlapped with the counter electrode/the reference electrode through the working electrode, so that the separation distance between the positive electrode and the negative electrode is zero, and the reverse ion permeation effect (reverse ion permeation) generated by the sweat glands can be avoided. Assume 100 glands/cm2And 4nL/min per gland, which is equivalent to 0.25cm when the positive and negative electrodes are spaced 0.5cm apart2Sweat at the skin-electrode interface produced 100 nL/min. However, the invention overlaps the positive and negative electrodes, and the micro-needles of the positive and negative electrodes are separated by 0.5mm, which is equivalent to less than 0.0025cm2Sweat production at the skin-electrode interface is less than 1 nL/min. Substantially so less than the amount of perspiration hardly affects the results of subcutaneous microneedle measurements.
Further, the sensing micro-needle can change the shape of two sides, so that the body sweat generated around the bottom of the sensing micro-needle can not invade the tip of the sensing micro-needle, thereby eliminating the interference factor of the body sweat on the tip sensing of the sensing micro-needle.
Furthermore, the bottom of the sensing micro-needle can be coated with a non-porous high molecular material, so that animal sweat generated around the bottom of the sensing micro-needle cannot invade the tip of the sensing micro-needle, and interference factors of the animal sweat on the tip sensing of the sensing micro-needle are eliminated.
Furthermore, an adsorption structure is designed around the bottom of the sensing microneedle, so that the body sweat generated around the bottom of the sensing microneedle can be adsorbed, and the interference factor of the body sweat on the tip sensing of the sensing microneedle can be eliminated.
Furthermore, a trench structure is designed around the bottom of the sensing microneedle, so that the body sweat generated around the bottom of the sensing microneedle can be guided to the outside of the sensing microneedle to volatilize, thereby eliminating the interference factor of the body sweat on the tip sensing of the sensing microneedle.
Further, after the non-porous polymer layer is coated around the bottom of the sensing microneedle, an antiperspirant, such as Aluminum Chloride (ACH) and aluminum chloride hexahydrate ointment (aluminum chloride hydrate waste), such as Drysol or anticholinergic agents (such as glycopyrrolate), is applied, so that most sweat glands in the skin-contacting portion of the microneedle substrate are temporarily affected by the antiperspirant and cannot sweat, and thus the sensing of the microneedle is not affected.
The invention relates to a physiological and biochemical monitoring device, which comprises: monitoring body for combine on the animal body skin, this monitoring body is equipped with first link on the surface, and this monitoring body includes:
the power supply unit is used for providing a power supply required by the operation of the monitoring body, and an opening is arranged on the surface of the monitoring body;
the central control unit is electrically connected with the power supply unit and the first connecting end and is used for controlling the operation and data transmission of the monitoring body;
the physiological sensor is electrically connected with the power supply unit and the central control unit, is used for monitoring physiological sensing signals of the animal body and can transmit the monitored physiological sensing signals to the central control unit;
the first connecting end is exposed out of the opening of the monitoring body;
the replaceable component is combined on the surface of the monitoring body and provided with an opening, wherein the replaceable component comprises:
the plurality of sensing microneedle sets are provided with two or more sensing microneedles, each sensing microneedle is combined with one or more sweat resisting elements, and the tips of every two or more sensing microneedles in the sensing microneedle sets can be gathered inwards;
the biochemical sensor is electrically connected with the sensing micro-needle groups and is used for monitoring biochemical signals of animals, wherein the biochemical sensor comprises:
the detection unit is used for acquiring different biochemical concentration change values at the same point according to different sensing microneedles after the two or more sensing microneedles perform micro-intrusion sensing towards any point on the skin of the animal body;
the processing unit is used for converting the detected biochemical concentration change value into a biochemical sensing signal;
the second connecting end is electrically connected with the processing unit and the first connecting end and is used for transmitting biochemical sensing signals to the central control unit through the first connecting end;
therefore, after the replaceable component is combined on the monitoring body, the monitoring body can monitor the physiological sensing signal and the biochemical sensing signal simultaneously.
Drawings
FIG. 1A is a schematic perspective view of a physiological and biochemical monitoring device according to the present invention;
FIG. 1B is a schematic diagram of the overall structure of a physiological and biochemical monitoring device according to the present invention;
FIG. 2A is a schematic diagram of a monitoring body of the physiological and biochemical monitoring device according to the present invention;
FIG. 2B is a schematic diagram of a biochemical sensor of the physiological and biochemical monitoring device according to the present invention;
FIG. 3A is a schematic view of a first embodiment of a sensing probe set of the physiological and biochemical monitoring device according to the present invention;
FIG. 3B is a schematic diagram of a first embodiment of a sensing probe set of the physiological and biochemical monitoring device according to the invention;
FIG. 4 is a schematic diagram of a second embodiment of a sensing probe set of the physiological and biochemical monitoring device according to the invention;
FIG. 5A is a schematic view of a third embodiment of a sensing probe set of the physiological and biochemical monitoring device according to the invention;
FIG. 5B is a schematic diagram of a third embodiment of a sensing probe set of the physiological and biochemical monitoring device according to the invention;
FIG. 5C is a schematic view of a third embodiment of a sensing probe set of the physiological and biochemical monitoring device according to the present invention;
FIG. 5D is a schematic diagram of a third embodiment of a sensing probe set of the physiological and biochemical monitoring device according to the invention;
FIG. 6A is a schematic diagram of a testing structure of a sensing probe set of the physiological and biochemical monitoring device according to the present invention;
FIG. 6B-1 is a schematic diagram of a first sweat-blocking implementation of the physiological and biochemical monitoring device according to the present invention;
FIG. 6B-2 is a schematic view of a first sweat-blocking implementation of the physiological and biochemical monitoring device according to the present invention;
FIG. 6C is a schematic diagram of a second sweat-blocking embodiment of the physiological and biochemical monitoring device according to the present invention;
FIG. 6D is a schematic diagram of a third exemplary embodiment of a sweat-blocking device according to the present invention;
FIG. 7 is a schematic view of a wearable application of the physiological and biochemical monitoring device according to the present invention;
FIG. 8 is a schematic view of a wearable application of the physiological and biochemical monitoring device according to the present invention;
FIG. 9A is a schematic view of another embodiment of a monitoring body of the physiological and biochemical monitoring device according to the invention;
FIG. 9B is a schematic diagram of an alternative embodiment of a replaceable component of the physiological and biochemical monitoring device according to the present invention;
FIG. 9C is a schematic perspective view of another embodiment of the physiological and biochemical monitoring device according to the present invention.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
Other technical matters, features and effects of the present invention will become apparent from the following detailed description of preferred embodiments, which is to be read in connection with the accompanying drawings.
The physiological and biochemical monitoring device of the invention, as shown in fig. 1A, 1B, 2A and 2B, can combine the replaceable component 2 on the monitoring body 1, the monitoring body 1 is used for combining on the skin of the animal body, and the monitoring body 1 is internally provided with a central control unit 11 and a power supply unit 14, the central control unit 11 is used for controlling the operation and transmission data of the monitoring body 1, and the power supply unit 14 is used for providing the power supply required by the operation of the monitoring body 1;
the replaceable component 2 can be fastened to the monitoring body 1, wherein the monitoring body 1 has a physiological sensor 12 and a biochemical sensor 13 inside, and openings 101,102 are opened on the surface of the monitoring body 1 aiming at the positions of the physiological sensor 12 and the biochemical sensor 13, so that the physiological sensor 12 and the biochemical sensor 13 can expose the detection port of the physiological sensor 12 and the first connection terminal 15 (the first connection terminal 15 is a connection circuit and is connected with the biochemical sensor 13, and the first connection terminal 15 can be directly designed on the biochemical sensor 13), the opening 20 of the replaceable component 2 can expose the opening 20 to the physiological sensor 12 (the detection port of the physiological sensor 12 can be parallel to the opening 20 or protrude from the opening 20), and the physiological sensor 12 and the biochemical sensor 13 are described as follows:
a physiological sensor 12 for monitoring a physiological sensing signal of the animal body and transmitting the monitored physiological sensing signal to the central control unit 11; wherein the physiological sensor 12 can be:
optical type sensors, such as photoplethysmographic sensors, blood oxygen sensors, blood pressure sensors.
Electrodes are micro-invasive sensors such as body surface impedance sensors, Electrocardiogram (ECG) sensors, surface electromyogram (sEMG) sensors, electroencephalogram (EEG) sensors.
Inertial motion detection sensors, such as speed sensors, acceleration sensors, angular velocity sensors, electronic compasses, magnetic field sensors, and multi-axis motion sensors, are used to measure the speed, acceleration, angular velocity, and azimuth of motion, and perform fusion calculation to determine the motion attitude and trajectory according to the speed or/and the acceleration, angular velocity, and azimuth.
A sensor for detecting temperature, such as a body surface temperature sensor.
The biochemical sensor 13 is configured to monitor biochemical signals (a blood glucose value, a lactic acid value, a uric acid value, a cholesterol value, a cortisol value, an alcohol value, a gas value, an ion value, a drug concentration value, or two or more values) of the animal, as shown in fig. 2B, the biochemical sensor 13 includes a detecting unit 131 and a processing unit 132, wherein the detecting unit 131 can obtain a biochemical concentration variation value through the first connection end 15, and then convert the detected biochemical concentration variation value into the biochemical sensing signal through the processing unit 132 in an electrochemical manner, and then transmit the biochemical sensing signal to the central control unit 11.
The biochemical sensor element may be a semiconductor element that senses the characteristics of the chemical substance or the change thereof and converts the sensed characteristics into an electrical signal. Thereby, the detection of the chemical substance, the physical, chemical or biochemical change is performed. The chemical substance sensor element is, for example, a semiconductor sensor element that senses a nerve conduction substance such as H +, K +, Ca2+, etc., a metabolite such as a metabolite produced inside or outside a cell or a metabolizable substance, a specific antigen or antibody, or a metabolite derived from these proteins, etc., and converts a signal based on information derived from the chemical substance to be detected into an electrical signal. The chemical substance sensor device may be an ion sensitive or chemical field effect transistor, ISFET, CHEMFET, or the like.
The physiological sensor 12 of the present invention is of the following types:
the optical sensor element acquires optical information related to an object to be measured to be sensed thereby. The optical information is information related to some light obtained by irradiating light to the measurement object. The optical sensor device may be a semiconductor device that senses an optical signal and converts the optical signal into an electrical signal. The light to be sensed may be visible light, ultraviolet light, infrared light, fluorescence, phosphorescence, luminescence, etc. This makes it possible to obtain morphological information of the object to be measured, distribution of the object to be measured, and information on distribution, concentration, behavior, and the like of the substance related to the object to be measured.
The electrical sensor element is a semiconductor element that acquires electrical information about a measurement object. The electrical sensor element may be a semiconductor element that senses a potential, a current value, a voltage value, and an impedance to generate a current or voltage signal in order to detect potential information such as an activity potential of a cell, a cell grounding degree, an intercellular adhesion or micro-invasion degree, an activation or activation state of a measurement object such as a cell, and the like. By generating a current or voltage signal, stimulation, activation, inactivation, or the like of the measurement object can be induced. Further, the sensor element may be a body surface temperature sensor element. The sensing at each element and the conversion of the information obtained from the sensing into electrical signals, etc. can be performed under the control of the control system. The sensor device may further include a sensor element for detecting another substance. The electrical sensor element is exemplified by a semiconductor sensor using an electrode, a semiconductor voltage sensor, and the like.
The pressure sensor element can detect the blood vessel pressure through the contraction deformation of the blood vessel wall by applying a pressure sensor and the like.
The replaceable component 2 is combined on the surface of the monitoring body 1, the replaceable component 2 comprises a plurality of micro-needle sheets which are overlapped, each micro-needle sheet is provided with one or more through holes, one or more sensing micro-needles are arranged at the edge of each through hole, and after the plurality of micro-needle sheets are overlapped, a sensing micro-needle group with a factor micro-needle sheet which is overlapped and penetrates out of the sensing micro-needles is formed.
At least one of the micro-needle sheets is a working electrode, the inner surface of the micro-needle sheet is modified with a sensing polymer, the sensing polymer is an aptamer specific to a target drug molecule, one end of the sensing polymer is modified with a self-assembly single molecule (SAM) and can be fixed on the inner surface of the working electrode, and the other end of the sensing polymer is modified with a redox reporter molecule (redox reporter). More specifically, in one embodiment, the working electrode is coated with gold first, then various sensing polymers are modified, the sensing polymer is modified with thiol SH at one end, and then aptamer is modified with methyl blue at the end. By using Square Wave Voltammetry (SWV) or DPV or chronoamperometry (chronoamperometry), various inflammations, immunoreactive molecules, or drugs and drugs that may be present in tissue fluid can be detected continuously.
The sensing molecules used by the sensing microneedles of the present invention essentially comprise specific aptamers, antibodies, etc., where the generality of the aptamers results from the multifunctional recognition and signal transduction properties of the aptamers, and the ability of nucleic acids to be selected for binding to specific molecular targets. By using well-established in vitro selection methods (SELEX), aptamers that bind to a wide range of analytes can be generated and can be rationally redesigned, within an arbitrarily wide or narrow concentration window, such that they undergo large-scale conformational changes upon binding of these analytes.
The biochemical sensor 13 of the present invention uses this conformational change to generate an electrochemical signal that is easily measured without the need for a target chemical transformation. To achieve this signal transduction, binding of the aptamer is used to induce a conformational change to alter the efficiency of the proximity of the covalently linked redox reporter molecule (here methylene blue) to the underlying electrode, and the current change that produces the target concentration dependence when the sensor is an electrode is interrogated with square wave voltammetry. Sensor signaling is independent of batch processing procedures, such as washing steps or addition of exogenous reagents, as required to support continuous in vivo measurements.
Furthermore, since the transdermal microneedle sensor signal is generated by a specific, binding-induced conformational change, rather than adsorption of the target to the sensor surface (SPR, QCM, FET and microcantilever cases), the platform is relatively insensitive to biological contamination (fouling). For example, previous studies have shown that transdermal microneedle sensors perform well in hours of flowing, undiluted serum, making them one of the strongest single-step biosensor platforms reported to date.
In addition, the structure of the sensing micro-needle is further described, wherein the micro-needle sheet can be made of 0.06-0.1mm stainless steel sheet, the height of the protruding array sensing micro-needle is 0.6-2mm, and the first embodiment described below is a three-layer (outermost layer: reference electrode; middle layer: working electrode; bottom layer: counter electrode), the stacking sequence can be selected arbitrarily, and the combined structure has the advantages of reduced area, and the number of the micro-needles between the layers can be reduced to only 2x2, and the corresponding area is reduced to 2 mm).
As shown in fig. 3A and 3B, the replaceable component 2 includes:
the first microneedle sheet 21 is used as a working electrode, the first microneedle sheet 21 is in a sheet shape, the first microneedle sheet 21 is provided with a first through hole 211, a first sensing microneedle 212 is arranged at the edge of the first through hole 211, and the edge of the first microneedle sheet 21 is provided with a second connecting end 213;
the second microneedle sheet 22 is used as a reference electrode, the second microneedle sheet 22 is in a sheet shape, the second microneedle sheet 22 is provided with a second perforation 221, the second perforation edge 221 is provided with a second sensing microneedle 222, and the edge of the second microneedle sheet 22 is provided with a second connecting end 223;
a third microneedle sheet 23 serving as a counter electrode, wherein the third microneedle sheet 23 is in a sheet shape, the third microneedle sheet 23 is provided with a third through hole 231, a third sensing microneedle 232 is disposed at an edge of the third through hole 231, and a second connection end 233 is disposed at an edge of the third microneedle sheet 23;
the first through hole 211, the second through hole 221 and the third through hole 231 are vertically overlapped with each other, so that the first sensing microneedle sheet 21, the second sensing microneedle sheet 22 and the third microneedle sheet 23 are in a triangular pyramid shape without mutual micro-invasion or a quadrangular pyramid with a missing side, so that the subcutaneous tissue fluid can effectively enter the inner surface of the spur to act with the sensing molecule (the three sensing microneedles are separated from each other without overlapping, wherein the range of the distance between the first sensing microneedle 212, the second sensing microneedle 222 and the third microneedle sheet 232 is a sensing microneedle set).
The second connection end 213, the second connection end 233, and the second connection end 233 are aligned to the first connection end 15 at different positions respectively, so as to achieve electrical connection by micro-intrusion.
Each of the micro-needle sheet slices can be packaged to the substrate PCB by an SMD (surface mounted device) mode, and the SMD can be bonded by using room temperature/normal temperature/low temperature conductive silver adhesive, or UV (ultraviolet) light curing conductive silver adhesive, or low-temperature riveting. When the metal sheets are stacked, electrical insulation is needed between layers, and the preferred stacking arrangement sequence in manufacturing is that the outermost layer (reference electrode), the middle layer (working electrode), and the bottommost layer (counter electrode), because the working electrode is usually required to be covered with a porous electrical insulation film for most of the whole outermost layer except for the sensing polymer, and therefore if the working electrode is disposed in the middle layer, the upper reference electrode and the bottom counter electrode can be just electrically isolated, and thus, the upper reference electrode and the bottom counter electrode do not need to be covered with the electrical insulation film for the outermost layer in manufacturing.
In the assembly, the metal sheet can be made into a DIP form and penetrates through the PCB substrate, the back surface is still combined by adopting room temperature/normal temperature/low temperature conductive silver adhesive or UV (ultraviolet) light curing conductive silver adhesive, and the substrate adopts a PCB double-layer board as a fixing effect, so that the assembly can be completed more simply. To allow for biocompatibility, the PCB needs to use a lead-free process. Biocompatible plastic substrates, injection molding for production, etc. may also be used.
In addition, as shown in fig. 4, the replaceable component 2 can also include only a first microneedle sheet 21 and a second microneedle sheet 22, wherein the second sensing microneedle 222 passes through the first through hole 211 and is opposite to the first sensing microneedle 212. In addition, the replaceable component 2 of the present invention is a separate structure, and thus can be removed to replace a new replaceable component 2 after use.
In addition, the present invention can also be described using the microneedle sheet format as shown in fig. 5A-5C as follows:
as shown in fig. 5A, the microneedle sheet 26 of the working electrode has four through holes 261, four sensing microneedles 262 and two connecting ends 263;
as shown in fig. 5B, the microneedle sheet 27 of the reference electrode (which can also be used as a counter electrode) has two through holes 271, two sensing microneedles 272 and two connecting ends 273;
as shown in fig. 5C, the microneedle sheet 26 and the microneedle sheet 27 can be stacked for measurement, wherein different microneedle sheets 27 or stacked microneedle sheets 27 can be used together to achieve biochemical measurement of three-in-one or even four-in-one.
As shown in fig. 5D, the working electrode micro-needle plate 26 and the reference electrode micro-needle plate 27 can be stacked, and the counter electrode micro-needle plate 27 '(having two through holes 271', two sensing micro-needles 272 'and two connecting ends 273') is stacked on the other side of the working electrode micro-needle plate 26, but is not in contact with the reference electrode micro-needle plate 27, so that the three-electrode electrochemical measurement can be performed.
In addition, the microneedle sheet is made of biocompatible or medical stainless steel material, when manufacturing, only the inner surface and the outer surface of the microneedle are plated with gold, while the reference electrode is only coated with a layer of Ag/AgCl on the microneedle, and the working electrode is coated with sensing molecules such as enzyme or aptamer, special attention needs to be paid, and the coating area only needs to be more than 2/3 of the height of the microneedle, even more than 1/2. In addition, the insulation part and prevention of biological interference, etc. require coating with a porous material. When the sensing polymer is enzyme, the porous material can be a hydrogel, a HEMA, an Epoxy-polyurethane-urethane (Epoxy-PU) film, a semi-permeable film, or a film with low oxygen permeability. When the sensing polymer is an aptamer, the sensing polymer may be a polysulfone fiber membrane (polysulfonone) or the like.
In a preferred embodiment of the present invention, the sensing microneedle working electrode is first roughened to increase its active area, and then gold-plated to form a gold electrode. DNA constructs specific for the target analyte, etc. were thawed and then reduced with a 1000-fold molar excess of tris (2-carboxyethyl) phosphine for 1 hour at room temperature. The freshly roughened gold electrodes were then rinsed in deionized water and then immersed in a solution of the appropriate reducing DNA construct at 200-500nM for 1 hour at room temperature. After this, the microneedle working electrode was covered with a polysulfone fiber membrane. The microneedle working electrode was soaked overnight for 12 hours in a 20mM 6-mercapto-1-hexanol solution in PBS at 4 ℃ to cover the remaining gold surface and remove non-specifically adsorbed DNA. Thereafter, the microneedle working electrode was rinsed with deionized water and stored in PBS.
The sensing micro-needle of the present invention can be formed by a stamping or etching process. The materials of the sensing micro-needles are selected from stainless steel, nickel alloy, titanium alloy or silicon materials. The sensing microneedles may also be made of resin such as polycarbonate, polymethacrylic acid copolymer, ethylene/vinyl acetate copolymer, teflon or polyester, and a biocompatible metal is deposited on the surface. The sensing microneedles are 400-1500 microns in height and 200-350 microns in substrate width. The tips of the sensing microneedles are spaced at 500 and 2000 microns apart.
In addition, two or more groups of microneedle sheets (not shown) can be mounted in the replaceable component 2, so that the present invention can be used to manufacture a two-in-one sensing system, such as simultaneously measuring blood glucose and insulin; or simultaneously measuring endotoxin and antibiotic.
In addition, each micro-needle sheet of the invention can be combined with various possible applications, and can be used for manufacturing two-in-one sensing systems, such as simultaneously measuring blood sugar and insulin; or a three-in-one sensing system for simultaneously measuring blood sugar, lactic acid, antibiotics, etc. Four-in-one sensing can be performed. Such as simultaneous measurement of blood glucose, lactate, uric acid, antibiotics, etc.
In addition, the embodiment of the present invention is that the electrochemical detection composed of three electrodes can have enzyme type sensing polymer, and the main detection circuit is biased to the electrochemical measurement circuit using the potentiostat; the use of sensing polymers such as antibodies, aptamers, or other non-enzymatic sensing polymers may be biased towards electrochemical read circuits using Square Wave Voltammetry (SWV), Differential Pulse Voltammetry (DPV), or Electrochemical Impedance Spectroscopy (EIS); if the reading efficiency is to be increased, the two microneedle sheet layers can be separated to correspond to the reading circuits of the enzyme and the non-enzyme respectively.
In addition, in some embodiments of the present invention, the reading circuit can be multifunctional, and simultaneously has reading circuits of a potentiostat, an SWV, a DPV, and an EIS, and only the switching of software and hardware switches is needed, so that the microneedle sets can be alternately switched to a single electrochemical reading circuit by using a multiplexer, the size of the whole monitoring system can be greatly reduced, the concentration of various analytes in a body can be simultaneously monitored, and the realization of real-time precise medicine is facilitated.
The present invention can continuously measure pure physiological signals or pure biochemical signals, such as electrocardiogram, blood pressure, blood oxygen, CORTISOL (CORTISOL) concentration, and lactate concentration, and can comprehensively evaluate the state of athletes coping with competition tension, in addition, the present invention further provides several embodiments for simultaneously measuring physiological signals and pure biochemical signals:
lactate sensing + nine axis IMU: the physiological and biochemical monitoring device of the invention is attached to each part of the body of the athlete, the muscle part which can be used during the sports and the part which can not be used, besides the lactic acid can be obtained, the sport intensity of the part can be known through the nine-axis IMU.
Lactate sensing + sEMG: when the physiological and biochemical monitoring device is attached to each part of the sportsman, the muscle part which can be used during the sports and the part which can not be used, the severity of the sports of the part can be known through sEMG besides the lactic acid can be obtained.
Lactate sensing + nine axis IMU + sEMG: when the physiological and biochemical monitoring device is attached to each part of the body of the athlete, the muscle parts which can be used during the exercise and the parts which can not be used, besides the lactic acid can be obtained, the exercise intensity of the part can be further known through the nine-axis IMU and the sEMG.
Drug concentration sensing + physiological signal: the method is very helpful for the animal body which is compliant with the medicine taking, and the influence of the blood concentration of the medicine, such as the medicine for reducing blood pressure, the analgesic medicine or various medicines, on the vital signals of the animal body can be continuously detected in real time.
In addition, the present invention can design various combinations of biochemical and physiological signal detecting modules based on pharmacology, main effect and side effect. The method comprises drug concentration sensing (such as hypertension drug or antithrombotic drug), main effect biochemical marker concentration sensing, side effect biochemical marker concentration sensing, three types in total, and basic physiological signals including heartbeat, blood pressure, blood oxygen, activity, etc.
However, if the method is applied to motion sensing of an athlete, a lot of sweat is generated due to the motion, and if only the sensing microneedle as shown in fig. 6A is used, the sweat will interfere with enzymes at the top of the sensing microneedle because the body sweat 31 of the subcutaneous tissue 3 will slightly invade the top of the sensing microneedle, so as shown in fig. 6B-1 and 6B-2, a sweat blocking element (protrusion 2321) is designed at the tail of the bottom of the sensing microneedle 232, so that the body sweat generated around the bottom of the sensing microneedle 232 cannot slightly invade the tips of the sensing microneedles 212,222,232, and thus the interference factor of the body sweat 31 to the tip sensing of the sensing microneedle 232 can be eliminated.
As shown in fig. 6C, the bottom of the sensing microneedles 212,222,232 can be coated with a non-porous polymer layer 24 (or coated with a non-porous polymer layer 24 before being coated with an antiperspirant (not shown), such as Aluminum Chloride (ACH), aluminum chloride hexahydrate hydrochloride (e.g., Drysol or anticholinergic agents), such as glycopyrronium bromide (glycopyrrolate), which makes the microneedle substrate such that most sweat glands from the portion of the sensing microneedles 212,222,232 surrounding the bottom and contacting the skin are temporarily affected by the antiperspirant and thus cannot sweat, and thus do not contact the tips of the sensing microneedles 212,222,232, so as to eliminate the interference factor of the sensing microneedles on the tips of the sensing microneedles 212,222, 232.
As shown in fig. 6D, a sweat blocking element (an absorption structure 25) can also be designed around the bottom of the sensing microneedles 212,222,232, so that the body sweat generated around the bottom of the sensing microneedles 212,222,232 can be absorbed to eliminate the interference factor of the body sweat on the tip sensing of the sensing microneedles 212,222,232, and in addition, the absorption structure 25 used in the present invention can be made of a polymer material such as water gel or a filter material made of a glass fiber material.
In addition, a sweat blocking element (non-porous polymer material) can be formed on the whole of the sensing microneedles 212,222,232 or at the tips of the sensing microneedles 212,222,232, so that the body sweat generated around the bottoms of the sensing microneedles 212,222,232 cannot invade the tips of the sensing microneedles 212,222,232, thereby eliminating the interference factors of the body sweat on the tip sensing of the sensing microneedles 212,222, 232.
In addition, a sweat blocking element (a trench structure (not shown) can be designed around the bottom of the sensing micro-needle 212,222,232, so that the body sweat generated around the bottom of the sensing micro-needle 212,222,232 can be guided to the outside of the sensing micro-needle 212,222,232 for volatilization, so as to eliminate the interference factor of the body sweat on the tip sensing of the sensing micro-needle 212,222, 232.
The monitoring body 1 combined with the replaceable component 2 can be worn on the animal body through a combining component 6, as shown in fig. 7, the monitoring body 1 can be worn on the arm 4 of the animal body, or as shown in fig. 8, the monitoring body 1 can be worn on the lower leg 5 of the animal body.
The technology of the invention can be used together with new drug testing, because new drug testing has very strict testing standards, so that the tested people must strictly observe the regulation to regularly measure physiological and biochemical data, but not every tested person can conveniently arrive in time to measure, so that the new drug testing will have flaws, and in addition, if the new drug testing is expanded, no equipment capable of achieving the purpose is provided by the current equipment; however, the device of the present invention can return the physiological and biochemical data of the tested person to the server in time, which can save the round trip time of the tested person, and in addition, can more accurately measure the desired data, which brings great convenience for new drug testing and can greatly reduce the time spent on new drug testing.
In terms of new drug development, since new drugs have a unique stage of development, commonly referred to as stages I to IV, dose tolerability and dose response exploration studies are conducted in the second or third phase, while pharmacokinetic studies usually involve these phases, but are usually only secondary targets; therefore, the usefulness of drug blood concentration monitoring (TDM) for therapeutic drugs has not been investigated for new drugs. Typically, the demand for TDM is only discovered after the drug has been put on the market.
TDM is particularly valuable in the following cases:
whether the relationship between drug concentration and effect is stronger than the relationship between dose and effect;
whether the clinical effect of the medicament is evaluated is not simple or not, and the definite clinical parameters can be used;
whether the treatment window is small;
recording the interaction;
monitoring drug compliance;
whether there is great variability and unpredictability in pharmacokinetic parameters within and between individuals. Our suggestion is that a random concentration control test should be performed at an early stage of drug development and that the test must enforce drug approval.
For one case, when studying the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of TJ301 in active ulcerative colitis patients, adverse events and vital signs are usually monitored, and in addition, the monitoring is generally performed by using a one-to-two lead electrocardiogram, and data of heartbeat, blood pressure and the like of a patient is measured and recorded.
In addition, when a clinical tester of a new drug adopts the invention, the invention can automatically or entrusts an aptamer professional development company to synthesize a corresponding drug aptamer aiming at the detected new drug, and then the aptamer is sleeved on the microneedle drug concentration sensor.
In addition, the power supply unit 14 of the monitoring body 1 of the present invention is a rechargeable battery or a replaceable battery, so if the monitoring body 1 is not powered, it can be wired for charging or replacing a lithium battery.
In addition, the monitoring body 1 of the present invention can further be combined with a screen or/and a micro microphone (not shown) on the outer surface.
In addition, as shown in fig. 9A-9C, the replaceable component 8 can be combined with the monitoring body 7, a central control unit 71, a physiological sensor 72 and a power supply unit 73 are arranged inside the monitoring body 7, the central control unit 11 is electrically connected with the first signal connection end 74, the power supply unit 73 is electrically connected with the first power connection end 75, and after combination, the physiological sensor 72 can be exposed from the opening 80;
and the replaceable component 8 comprises:
a plurality of sensing microneedle sets 81, wherein the sensing microneedle set 81 has two or more sensing microneedles, each sensing microneedle is combined with one or more sweat-blocking elements, and the tips of every two or more sensing microneedles in the sensing microneedle set can be gathered inwards (the same as the above, so the illustration is not repeated);
a biochemical sensor 82 electrically connected to the sensing micro-needle sets 81 for monitoring biochemical signals of the animal, wherein the biochemical sensor 82 comprises:
a detecting unit 821, configured to obtain different biochemical concentration variation values at the same point according to different sensing microneedles after the two or more sensing microneedles perform micro-intrusion sensing towards any point on the skin of the animal; the detecting unit 821 is electrically connected to a second signal connection terminal;
the processing unit 822 is used for converting the detected biochemical concentration variation value into a biochemical sensing signal.
A power supply unit 83 for providing power for the operation of the biochemical sensor 82;
a second signal connection terminal 84 electrically connected to the detection unit 821 of the biochemical sensor 82;
the second power connection 85 is electrically connected to the power supply unit 83.
Therefore, when the monitoring body 7 is combined with the replaceable component 8, the first signal connection terminal 74 is electrically connected to the second signal connection terminal 84, and the first power connection terminal 75 is electrically connected to the second power connection terminal 85, so as to provide power to the replaceable component 8 through the power supply unit 73;
then, after the sensing micro-needle set 81 performs micro-intrusion sensing towards any point on the skin of the animal, the detecting unit 821 can obtain different analyte concentrations at the same point according to different sensing micro-needles, and convert the signal through the processing unit 822 to obtain a biochemical sensing signal, and finally transmit the biochemical sensing signal to the central control unit 71 through the second signal connection end 84 and the first signal connection end 74.
Although the above description and examples are directed to animals, the invention is not limited thereto, and animals such as cats, dogs, cows, beads, sheep, tigers, fish, etc. may be used.
The physiological and biochemical monitoring device provided by the invention has the following advantages when compared with other well-known technologies:
the invention can develop a device capable of continuously measuring, can measure physiological data of electrocardiogram, blood pressure and blood oxygen, and can also measure biochemical data of cortisol concentration and lactic acid concentration, so that various physiological and biochemical signals can be measured simultaneously, and the device is applied to the field of animal body state measurement.
The present invention is not limited to the above embodiments, and those skilled in the art can understand the technical features and embodiments of the present invention and make various changes and modifications without departing from the spirit and scope of the present invention.
In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", and the like, indicate orientations and positional relationships based on those shown in the drawings, and are used only for convenience of description and simplicity of description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be considered as limiting the present invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.
In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above should not be understood to necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, various embodiments or examples described in this specification can be combined and combined by those skilled in the art.
Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that variations, modifications, substitutions and alterations can be made to the above embodiments by those of ordinary skill in the art within the scope of the present invention.
Claims (10)
1. A physiological and biochemical monitoring device, comprising:
monitoring body for combine on the animal body skin, this monitoring body is equipped with first link on the surface, and this monitoring body includes:
the power supply unit is used for providing power supply required by the operation of the monitoring body, and an opening is arranged on the surface of the monitoring body;
the central control unit is electrically connected with the power supply unit and the first connecting end and is used for controlling the operation and data transmission of the monitoring body;
the physiological sensor is electrically connected with the power supply unit and the central control unit, is used for monitoring physiological sensing signals of the animal body and can transmit the monitored physiological sensing signals to the central control unit;
the biochemical sensor is electrically connected with the power supply unit, the central control unit and the first connecting end and is used for monitoring biochemical signals of an animal body, wherein the biochemical sensor comprises:
a detecting unit for detecting and obtaining the biochemical concentration variation value;
the processing unit is used for converting the detected biochemical concentration change value into a biochemical sensing signal and transmitting the biochemical sensing signal to the central control unit;
a replaceable component, which is combined on the surface of the monitoring body and is provided with an opening, wherein the replaceable component comprises:
the plurality of sensing microneedle sets are provided with two or more sensing microneedles, each sensing microneedle is combined with one or more sweat resisting elements, and the tips of every two or more sensing microneedles in the sensing microneedle sets can be gathered inwards;
the second connecting end is electrically connected with the first connecting end and is used for obtaining different biochemical concentration change values according to different sensing micro-needles at the same point position through the connection of the detecting unit of the biochemical sensor and the second connecting end after the micro-invasion sensing is carried out on any point of the skin of the animal body by two or more sensing micro-needles; after the replaceable component is combined on the monitoring body, the monitoring body can monitor physiological sensing signals and biochemical sensing signals simultaneously.
2. The physiological and biochemical monitoring device of claim 1, wherein the physiological sensor is one of a photoplethysmography sensor, a blood oxygen sensor, a blood pressure sensor, a body surface impedance sensor, an electrocardiography sensor, a surface electromyography sensor, a brain wave sensor, a velocity sensor, an acceleration sensor, an angular velocity sensor, an electronic compass, a magnetic field sensor, a multi-axis motion sensor, a body surface temperature sensor.
3. The physiological and biochemical monitoring device of claim 1, wherein the biochemical sensor is configured to measure a blood glucose value, a lactate value, a uric acid value, a cholesterol value, a cortisol value, an alcohol value, a gas value, an ion value, a concentration of a drug administered, or two or more thereof.
4. The physiological and biochemical monitoring device according to claim 1, wherein the processing unit is capable of electrochemically converting the detected biochemical concentration variation into the biochemical sensing signal.
5. The physiological and biochemical monitoring device of claim 1, further comprising a coupling member for enabling the monitoring body to be secured to the animal body such that the monitoring body can be brought into contact with or be minimally invasive to the skin of the animal body.
6. The physiological and biochemical monitoring device according to claim 1, wherein the sensing micro-needle is made of stainless steel, nickel alloy, titanium alloy or silicon material, and a biocompatible metal is deposited on the surface thereof, and additionally or alternatively, a sensing polymer and a porous protection layer can be modified on the surface of at least one of the sensing micro-needles in the sensing micro-needle set.
7. The physiological and biochemical monitoring device according to claim 1, wherein the replaceable component includes a plurality of stacked microneedle sheets, each microneedle sheet having one or more through holes, wherein one or more sensing microneedles are disposed at an edge of each through hole, and a plurality of the microneedle sheets are stacked to form a sensing microneedle set having a plurality of microneedle sheets stacked to penetrate through the sensing microneedles.
8. The physiological and biochemical monitoring device of claim 7, wherein the replaceable component includes:
the first microneedle sheet is used as a working electrode, is in a sheet shape, is provided with a first perforation, and is provided with a first sensing microneedle at the edge;
the second microneedle sheet is used as a reference electrode, is in a sheet shape, is provided with a second perforation, and is provided with a second sensing microneedle at the edge of the second perforation;
wherein the first perforation and the second perforation are in the same vertical position, the first microneedle sheet and the second microneedle sheet are overlapped with each other, and the first sensing microneedle and the second sensing microneedle are separated from each other and are not overlapped.
9. The physiological and biochemical monitoring device according to claim 1, wherein the sensing microneedle can change the shape of both sides so that the sweat generated around the bottom of the sensing microneedle can not invade the tip of the sensing microneedle, thereby eliminating the interference factor of the sweat on the tip sensing of the sensing microneedle; or the bottom of the sensing micro-needle can be coated with a non-porous high molecular material, so that the animal sweat generated around the bottom of the sensing micro-needle can not invade the tip of the sensing micro-needle, thereby eliminating the interference factor of the animal sweat on the tip sensing of the sensing micro-needle; or an adsorption structure is designed around the bottom of the sensing microneedle, so that animal body sweat generated around the bottom of the sensing microneedle can be adsorbed, and interference factors of the animal body sweat on the tip sensing of the sensing microneedle are eliminated; or a trench structure is designed around the bottom of the sensing micro-needle, so that the body sweat generated around the bottom of the sensing micro-needle can be guided to the outside of the sensing micro-needle to be volatilized, and interference factors of the body sweat on the tip sensing of the sensing micro-needle are eliminated.
10. A physiological and biochemical monitoring device, comprising:
monitoring body for combine on the animal body skin, this monitoring body is equipped with first link on the surface, and this monitoring body includes:
the power supply unit is used for providing power supply required by the operation of the monitoring body, and an opening is arranged on the surface of the monitoring body;
the central control unit is electrically connected with the power supply unit and the first connecting end and is used for controlling the operation and data transmission of the monitoring body;
the physiological sensor is electrically connected with the power supply unit and the central control unit and is used for monitoring physiological sensing signals of the animal body and transmitting the monitored physiological sensing signals to the central control unit;
the first connecting end is exposed out of the opening of the monitoring body;
the replaceable component is combined on the surface of the monitoring body and provided with an opening, wherein the replaceable component comprises:
the plurality of sensing microneedle sets are provided with two or more sensing microneedles, each sensing microneedle is combined with one or more sweat resisting elements, and the tips of every two or more sensing microneedles in the sensing microneedle sets can be gathered inwards;
biochemical sensor, with this several sensing micropin group electric connection for monitor animal's biochemical signal, wherein this biochemical sensor includes:
the detection unit is used for acquiring different biochemical concentration change values at the same point according to different sensing microneedles after the two or more sensing microneedles perform micro-intrusion sensing towards any point on the skin of the animal body;
the processing unit is used for converting the detected biochemical concentration change value into a biochemical sensing signal;
the second connecting end is electrically connected with the processing unit and the first connecting end and is used for transmitting biochemical sensing signals to the central control unit through the first connecting end; after the replaceable component is combined on the monitoring body, the monitoring body can monitor physiological sensing signals and biochemical sensing signals simultaneously.
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| TWI730503B (en) | 2021-06-11 |
| TW202120022A (en) | 2021-06-01 |
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