CN217566069U - Tissue fluid detection device and system - Google Patents
Tissue fluid detection device and system Download PDFInfo
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- CN217566069U CN217566069U CN202220116967.6U CN202220116967U CN217566069U CN 217566069 U CN217566069 U CN 217566069U CN 202220116967 U CN202220116967 U CN 202220116967U CN 217566069 U CN217566069 U CN 217566069U
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Abstract
The utility model discloses a tissue fluid detection device and a system, which comprises a microneedle array, a microneedle matching shell, a patterned sensor electrode array, an air suction pump and a control circuit; the microneedle matching shell comprises a first interface, a second interface and a third interface, the microneedle array is fixed through the first interface, the patterned sensor electrode array is fixed through the second interface, and the suction pump is connected through the third interface; the patterned sensor electrode array is disposed on a back side of the microneedle array; the surface of part of the sensor electrodes in the patterned sensor electrode array is modified with a composite layer; the control circuit is connected with the air pump. The embodiment of the utility model provides a can detect many biomarker information in succession, the injury is little and sensitivity is high, but wide application in medical instrument technical field.
Description
Technical Field
The utility model relates to the technical field of medical equipment, especially, relate to a tissue fluid detection device and system.
Background
The tissue fluid is a medium for exchanging substances between blood and tissue cells, and other components except proteins are basically the same as the blood, so that the detection of certain biological indexes, such as monitoring blood sugar information, can be realized through the detection of the tissue fluid. Diabetes is a chronic disease which seriously affects the life quality and life health of patients, the diagnostic standard of diabetes is blood sugar concentration, and the detection and analysis of the blood sugar concentration are beneficial to timely treatment of the diabetes patients. The advanced diabetes multi-parameter monitoring system can obtain the in-vivo levels of multiple biomarkers, so that doctors can timely acquire the disease development of patients and carry out timely treatment, and the system has great significance.
Conventional blood glucose tests, such as finger tip blood sampling, can only obtain current blood glucose levels. The implanted blood glucose monitoring system can realize continuous monitoring of blood glucose level by implanting subcutaneous blood glucose sensing electrodes, but the electrodes implanted in the body easily cause immunological rejection, so measurement deviation is caused, the popularization of the implanted blood glucose monitoring system can also be influenced by the psychological acceptance of patients, and the simultaneous measurement of multiple parameters including blood glucose, pH and ROS is not reported.
SUMMERY OF THE UTILITY MODEL
In view of the above, an object of the embodiments of the present invention is to provide a tissue fluid detection device and system, which can continuously detect multi-biomarker information, and has small damage and high sensitivity.
The embodiment of the utility model provides a tissue fluid detection device, which comprises a microneedle array, a microneedle matched shell, a patterned sensor electrode array, an air pump and a control circuit; wherein the content of the first and second substances,
the microneedle matching housing comprises a first interface, a second interface and a third interface, the microneedle array is fixed through the first interface, the patterned sensor electrode array is fixed through the second interface, and the suction pump is connected through the third interface;
the patterned sensor electrode array is disposed on a back side of the microneedle array; the surface of part of the sensor electrodes in the patterned sensor electrode array is modified with a composite layer;
the control circuit is connected with the air pump.
Optionally, the patterned sensor electrode array comprises any one of a cylindrical bump array, a square bump array, a cylindrical recess array, or a square recess array.
Optionally, the interval between the sensor electrodes in the patterned sensor electrode array ranges from 10um to 25um, the height or depth of the sensor electrodes is less than or equal to 25um, and the width of the sensor electrodes is less than or equal to 25um.
Optionally, the material of the microneedle matching housing comprises any one of acrylonitrile-butadiene-styrene copolymer, polycarbonate, polyamide, polylactic acid, thermosetting plastic or photosensitive resin.
Optionally, the material of the microneedle array comprises any one of polymethylmethacrylate, epoxy, polylactic acid, or a metal with a biocompatible covering.
Optionally, the shape of the microneedles in the microneedle array includes any one of a prism with an apex, a pyramid, a cylinder with an apex, or a cone, the height of the microneedles is less than or equal to 1500um, the width of the microneedles is less than or equal to 400um, and the distance between the microneedles is in the range of 1000um to 1500um.
Optionally, the patterned sensor electrode array comprises a working electrode, a reference electrode and a counter electrode, the area of the working electrode being larger than the area of the reference electrode or the counter electrode.
Optionally, the control circuit includes a controller module, a power supply module and a wireless communication module, the controller module is connected to the wireless communication module and the air pump, and the power supply module provides electric energy for the device.
Optionally, the controller module includes a single chip or an ARM chip.
The embodiment of the utility model provides a tissue fluid detecting system, the system includes user terminal and foretell device.
Implement the embodiment of the utility model provides a include following beneficial effect: the embodiment of the utility model provides an in interstitial fluid detection device includes the micropin array, the supporting shell of micropin, patterned sensor electrode array, aspiration pump and control circuit, the fixed micropin array of the supporting shell of micropin and patterned sensor electrode array, the aspiration pump is connected to the supporting shell of micropin simultaneously, pierce skin with contact interstitial fluid through the micropin array, the injury nature is little, form the negative pressure in the supporting shell of messenger's micropin through the aspiration pump in order to draw interstitial fluid, the many biomarkers signal of telecommunication in the sensor electrode array detection interstitial fluid through patterning, convert the biomarker signal of telecommunication into relevant concentration information through control circuit, the sensitivity that detects is further improved to the surface modification's of sensor electrode composite bed simultaneously.
Drawings
Fig. 1 is a side sectional view of a tissue fluid detecting device according to an embodiment of the present invention;
FIG. 2 is a top view of a tissue fluid detection device according to an embodiment of the present invention;
fig. 3 is a side sectional view of an air extracting pump according to an embodiment of the present invention;
fig. 4 is a schematic diagram of a three-electrode structure of a patterned sensor electrode according to an embodiment of the present invention;
fig. 5 is a schematic structural diagram of a glucose electrode layer according to an embodiment of the present invention;
FIG. 6 is an SEM magnified view of a patterned sensor electrode with MWCNT: PEDOT: PSS according to an embodiment of the present invention;
fig. 7 is an SEM topographic representation of a patterned sensor electrode with different patterns according to an embodiment of the present invention;
fig. 8 is a block diagram of a control circuit according to an embodiment of the present invention;
fig. 9 is a graph of voltage response of a patterned sensor electrode to pH according to an embodiment of the present invention;
fig. 10 is a diagram of a patterned sensor electrode pair H according to an embodiment of the present invention 2 O 2 The current response of (c);
fig. 11 is a cyclic voltammogram of a glucose working electrode provided by an embodiment of the present invention;
fig. 12 is a graph of current response of a patterned sensor electrode to glucose according to an embodiment of the present invention.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings and specific embodiments.
Referring to fig. 1 to 3, fig. 1 is a side sectional view of a tissue fluid detection device, fig. 2 is a top view of the tissue fluid detection device, fig. 3 is a side sectional view of a suction pump, an embodiment of the present invention provides a tissue fluid detection device, which includes a micro needle array 20, a micro needle matching housing 30, a patterned sensor electrode array 10, a suction pump 40 and a control circuit; wherein, the first and the second end of the pipe are connected with each other,
the microneedle matching housing 30 comprises a first interface, a second interface and a third interface, the microneedle array 20 is fixed through the first interface, the patterned sensor electrode array 10 is fixed through the second interface, and the suction pump 40 is connected through the third interface;
the patterned sensor electrode array 10 is disposed on the back side of the microneedle array 20; the surfaces of some sensor electrodes in the patterned sensor electrode array 10 are modified with composite layers;
the control circuit is connected to the air pump 40.
Specifically, the patterned sensor electrode may adopt a photo-curing resin substrate electrode or a PDMS (Polydimethylsiloxane) substrate electrode prepared by combining a mold method with a micro-processing technology; the micro-needle array can adopt a light-cured resin micro-needle prepared by 3D printing or micro injection molding; the microneedle matching shell can be a plastic shell formed by 3D printing or micro injection molding, is specially designed for the size of the microneedle, is provided with a gas extraction channel at the top and an electrode embedding channel at the side, and realizes liquid extraction and detection while ensuring the air tightness of the device; the air extracting pump can be a light air extracting device available on the market; the control circuit can be a flexible circuit board.
It should be noted that the specific material of the composite layer is determined according to the practical application, and the embodiment is not particularly limited.
The microneedle array is used for puncturing the stratum corneum of the skin, so that interstitial fluid can permeate upwards along the inner pore passages of the microneedles; by arraying the microneedles, the process of breaking the skin can be effectively ensured, and the tissue fluid extraction efficiency can be improved. The microneedle array housing serves to hold the microneedle array and patterned sensor electrodes and to provide a gas extraction channel. The patterned sensor electrode is a patterned substrate prepared by a micro-processing or mold method, so that the stable adhesion of surface metal during testing can be effectively ensured, and the testing sensitivity and the linear range are improved; the patterned sensor electrodes are placed on the back of the microneedle array, which essentially couples MWCNTs: PEDOT (multi-walled carbon nanotube: poly (3, 4-ethylenedioxythiophene): polystyrene sulfonate) and other composite layers are modified on the surface of the electrode, so that the performance of the current sensor is improved, and glucose oxidase or an ion selective membrane is modified to realize a functionalized layer to be used as a working electrode. When the patterned sensor electrode is contacted with the extracted interstitial fluid liquid, the biomarker generates an electrical response on the surface of the electrode, and continuously generates relevant electrical signals such as glucose, ROS (reactive oxygen species), pH level and the like, so that the real-time detection of the interstitial fluid is realized. The air pump can perform air suction and pressure reduction actions to form certain negative pressure in the microneedle device so as to realize the extraction of tissue fluid, and the maximum power can reach the air suction speed of 300mL/min during air suction. And the control circuit is used for controlling the air suction pump and acquiring a biomarker response signal of the extracted tissue fluid detected by the patterned sensor electrode through the multi-channel circuit.
Specifically, the patterned sensor electrode uses a three-electrode system, namely a working electrode, a reference electrode and a counter electrode, and each electrode is modified with a functional material corresponding to the electrode. In this embodiment, the corresponding working electrodes include a glucose working electrode channel, an ROS working electrode channel, and a pH working electrode channel; wherein the pH working electrode channel works with a two-electrode system, i.e. without a counter electrode. Referring to fig. 4, for the glucose test example, 301 represents the glucose working electrode channel, 302 represents the Ag/AgCl reference electrode channel, and 303 represents the platinum counter electrode channel.
The relevant parameters for each electrode in a three-electrode system are as follows:
reference electrode: carrying out magnetron sputtering on a platinum layer with a certain thickness on the patterned sensor electrode substrate, wherein the thickness is not less than 400nm; then coating silver/silver chloride conductive slurry on the platinum layer, and baking for more than 2h in an environment of 80 ℃.
Counter electrode: and carrying out magnetron sputtering on a platinum layer with a certain thickness on the patterned electrode substrate, wherein the thickness is not less than 400nm.
Glucose working electrode channel: referring to fig. 5, a platinum layer with a certain thickness is magnetron sputtered on the patterned electrode substrate, wherein the thickness is not less than 400nm; then a layer of MWCNTs is deposited by means of electrodeposition: PEDOT: a PSS electron dielectric layer; and then, uniformly mixing 100mg/mL of glucose oxidase solution, 80mg/mL of bovine serum albumin solution and 2.5% of glutaraldehyde solution on the surface of the electronic medium according to the volume ratio of 2. MWCNT, PEDOT, PSS electronic interlayer is used as the electronic conduction interlayer of the electrode to realize Direct Electron Transfer (DET), thereby increasing the electrochemical activity of the electrode; referring to the SEM partial enlarged view of MWCNT: PEDOT: PSS patterned sensor electrode in FIG. 6, it can be seen that after electrodeposition, a layer of MWCNT: PEDOT: PSS is deposited on the surface of the electrode originally sputtered with the Pt layer, and a thicker MWCNT: PEDOT: PSS is deposited on the edge of the cylindrical pattern due to the larger current density.
ROS working electrode channel: and carrying out magnetron sputtering on a platinum layer with a certain thickness on the patterned electrode substrate, wherein the thickness is not less than 400nm.
pH working electrode channel: carrying out magnetron sputtering on a platinum layer with a certain thickness on the patterned electrode substrate, wherein the thickness is not less than 400nm; and then adding a pH sensitive membrane solution, standing and drying, and acidifying for more than 5 hours in vacuum to obtain a pH working electrode channel.
It should be noted that the size of the patterned sensor electrode is smaller than that of the microneedle array and smaller than that of the microneedle matching housing, so as to be conveniently embedded into the microneedle matching housing and work in cooperation with the microneedle array; and the effective sensing area of the patterned sensor electrode is smaller than the substrate area of the microneedle array; the patterned sensor electrodes can be embedded in channels left in the side of the microneedle mating housing and contact the back of the microneedles.
Alternatively, referring to fig. 7, the patterned sensor electrode array includes any one of a cylindrical bump array, a square bump array, a cylindrical recess array, or a square recess array.
Optionally, the interval between the sensor electrodes in the patterned sensor electrode array ranges from 10um to 25um, the height or depth of the sensor electrodes is less than or equal to 25um, and the width of the sensor electrodes is less than or equal to 25um.
It should be noted that the specific pattern and the related dimension of the patterned sensor electrode array are determined according to the practical application, and the embodiment is not limited in particular.
Optionally, the material of the microneedle matching housing comprises any one of acrylonitrile-butadiene-styrene (ABS), polycarbonate (PC), polyamide (PA), polylactic acid (PLA), thermosetting plastic or photosensitive resin.
It should be noted that the material of the microneedle matching housing is determined according to the practical application, and this embodiment is not particularly limited.
Optionally, the material of the microneedle array comprises any one of Polymethylmethacrylate (PMMA), epoxy, polylactic acid, or metal with a biocompatible covering.
The microneedle array is a biocompatible material having a certain hardness, and the metal includes a titanium alloy and the like.
Optionally, the shape of the microneedles in the microneedle array includes any one of a prism with an apex, a pyramid, a cylinder with an apex, or a cone, the height of the microneedles is less than or equal to 1500um, the width of the microneedles is less than or equal to 400um, and the distance between the microneedles is in the range of 1000um to 1500um.
In a specific embodiment, the microneedle array may be arranged in a 2 x 2 square matrix, each microneedle having a height of 1200 micrometers, a substrate diameter of 400 micrometers, and a spacing of 1000 micrometers between microneedles.
Optionally, the patterned sensor electrode array comprises a working electrode, a reference electrode and a counter electrode, the area of the working electrode being larger than the area of the reference electrode or the counter electrode.
Optionally, the control circuit includes a controller module, a power supply module and a wireless communication module, the controller module is connected to the wireless communication module and the air pump, and the power supply module provides electric energy for the device.
It should be noted that the specific form of the wireless communication module is determined according to practical application, and the embodiment is not particularly limited, for example, the bluetooth module or the WIFI module, and the chip may be CC2640R 2F. The controller module can transmit the acquired data to the user terminal in a serial port transparent transmission mode, and the user terminal app processes and displays the received multi-biomarker concentration data.
Referring to fig. 8, the three-electrode circuit of the controller module mainly includes a voltage follower, a control amplifier, a feedback follower, and a transimpedance amplifier. The voltage follower can play a role in impedance matching, the potential difference between the reference electrode and the working electrode is regulated and controlled, the current passing through the working electrode is amplified and converted into voltage by the trans-impedance amplifier, and the trans-impedance amplifier realizes the feedback conversion from the current to the voltage.
Optionally, the controller module comprises a single chip or an ARM chip.
It should be noted that the single chip or the ARM chip is determined according to practical applications, such as an STM32F103 chip.
In one specific embodiment, the results of the in vitro electrochemical assay performed on the interstitial fluid assay device are as follows:
the performance of the pH working electrode is detected firstly, the performance of the pH working electrode is continuously analyzed in pH buffer solutions with different pH values (5-8), and an open-circuit voltage test is tested. The pH sensitivity was measured by starting with a solution at pH 5, measuring each solution for 200s, and after stabilization, measuring the next solution and repeating the measurement 3-5 times. The results are shown in FIG. 9, and it can be seen from the results that the voltage response of the patterned sensor electrode to pH was goodGood linearity, wherein R 2 Is 0.996.
The performance of the ROS working electrode was then tested and analyte H was added continuously to PBS 2 O 2 And subjecting it to a chronoamperometric test, H 2 O 2 The sensitivity was 5mM H added dropwise to PBS after 200s stabilization 2 O 2 The solution, each response time lasting 200s, repeated 3-5 times. The results are shown in FIG. 10, from which it can be seen that the sensor electrode pairs H were patterned 2 O 2 Exhibits good linearity of current response of (1), wherein R 2 And was 0.995.
And finally, detecting the performance of the glucose working electrode, namely, cyclic voltammetry testing and chronoamperometry testing. The cyclic voltammetry test was performed by repeating 10 times cyclic voltammetry scans of the prepared glucose working electrode in a PBS solution having a concentration of 10mM glucose using a scan rate of 100mV/s at a voltage ranging from 0.8 to-0.2V, and the results are shown in FIG. 11. The results show that after 10 cycles, their cyclic voltammograms almost completely coincide, indicating that the glucose working electrode surface of this patterned sensor electrode has been very stable. The chronoamperometric assay was performed by continuously adding the analyte glucose solution to PBS, and after 30s stabilization, sequentially dropping the 1mM, 2mM, 6mM, and 4mM glucose solutions to PBS 8 times, each time with a response time of 200s, and repeating the measurement 3 to 5 times, and the results are shown in FIG. 12. It can be seen from FIG. 12 that the patterned sensor electrode exhibited a good linear range, R, for the current response to glucose 2 0.996, whereas in human blood the normal range of blood glucose concentration is about 3.6-7.5 mM on fasting plasma (fasting plasma glucose above 7.0mM is likely to be diabetic). Therefore, it is feasible to detect the blood glucose level of a diabetic patient using the patterned sensor electrode.
Implement the embodiment of the utility model provides a include following beneficial effect: the embodiment of the utility model provides an in interstitial fluid detection device includes the micropin array, the supporting shell of micropin, patterned sensor electrode array, aspiration pump and control circuit, the fixed micropin array of the supporting shell of micropin and patterned sensor electrode array, the aspiration pump is connected to the supporting shell of micropin simultaneously, pierce skin with contact interstitial fluid through the micropin array, the injury nature is little, form the negative pressure in the supporting shell of messenger's micropin through the aspiration pump in order to draw interstitial fluid, the many biomarkers signal of telecommunication in the sensor electrode array detection interstitial fluid through patterning, convert the biomarker signal of telecommunication into relevant concentration information through control circuit, the sensitivity that detects is further improved to the surface modification's of sensor electrode composite bed simultaneously.
The embodiment of the utility model provides a tissue fluid detecting system, the system includes user terminal and foretell device.
Specifically, the user terminal includes, but is not limited to, a mobile phone, a tablet computer, a desktop computer, or a videophone watch. The user terminal is used for setting the control circuit, displaying abnormal data or prompting alarm information and the like.
The use of the interstitial fluid device in this embodiment is as follows:
(1) After the patterned sensor electrode, the microneedle array, and the microneedle matching housing are assembled according to the structure of fig. 1, they are fixed on the skin by using a medical adhesive tape or a pressure sensitive adhesive. The tip of the microneedle array is aligned to the skin, and the vent hole of the microneedle matched shell is connected with the portable air pump through a thin tube, so that the control circuit and the patterned sensor electrode are well electrically connected.
(2) After the fixation is finished, the user terminal is connected in a matched mode through the wireless communication module of the control circuit, on one hand, the user terminal can obtain tissue fluid biomarker signals from the patterned sensor electrode in real time, and on the other hand, the user terminal can control the opening and closing of the portable suction pump through operation instructions.
(3) And setting a certain working time and starting the portable air pump. The portable air pump starts to pump air and is closed when reaching the preset value. At the moment, the air pressure in the device formed by the microneedle matching shell and the microneedle array is reduced to a certain value, and the interstitial fluid can be extracted to the back of the microneedles by the microneedle array due to pressure difference.
(4) After the interstitial fluid extracted to the back of the micro-needle is contacted with the patterned sensor electrode, the biomarker in the interstitial fluid can generate electrochemical response signals on the surface of each working electrode, corresponding potential or current signals reflect the concentration of glucose, ROS and pH in the interstitial fluid, and the electrochemical response signals are collected and processed in real time by the interstitial fluid micro-extraction sensing system and are transmitted to a user terminal.
(5) The steps (2) to (4) may be carried out continuously or intermittently as required.
While the preferred embodiments of the present invention have been described, the present invention is not limited to the embodiments, and those skilled in the art can make various equivalent modifications or substitutions without departing from the spirit of the present invention, and such equivalent modifications or substitutions are intended to be included within the scope of the present invention as defined by the appended claims.
Claims (10)
1. A tissue fluid detection device is characterized by comprising a microneedle array, a microneedle matched shell, a patterned sensor electrode array, an air suction pump and a control circuit; wherein the content of the first and second substances,
the microneedle matching housing comprises a first interface, a second interface and a third interface, the microneedle array is fixed through the first interface, the patterned sensor electrode array is fixed through the second interface, and the suction pump is connected through the third interface;
the patterned sensor electrode array is disposed on a back side of the microneedle array; the surface of part of the sensor electrodes in the patterned sensor electrode array is modified with a composite layer;
the control circuit is connected with the air pump.
2. The apparatus of claim 1, wherein the patterned sensor electrode array comprises any one of a cylindrical bump array, a square bump array, a cylindrical recess array, or a square recess array.
3. The device of claim 2, wherein the patterned sensor electrode array has a spacing between sensor electrodes ranging from 10um to 25um, the sensor electrodes have a height or depth less than or equal to 25um, and the sensor electrodes have a width less than or equal to 25um.
4. The device of claim 1, wherein the material of the microneedle mating housing comprises any one of acrylonitrile-butadiene-styrene, polycarbonate, polyamide, polylactic acid, a thermosetting plastic, or a photosensitive resin.
5. The device of claim 1, wherein the material of the microneedle array comprises any one of polymethylmethacrylate, epoxy, polylactic acid, or metal with a biocompatible covering.
6. The device of claim 1, wherein the shape of the microneedles in the microneedle array comprises any one of pointed prisms, pyramids, pointed cylinders or cones, the height of the microneedles is less than or equal to 1500um, the width of the microneedles is less than or equal to 400um, and the distance between the microneedles is in the range of 1000um to 1500um.
7. The device of claim 1, wherein the patterned sensor electrode array comprises a working electrode, a reference electrode, and a counter electrode, the working electrode having an area greater than the area of the reference electrode or the counter electrode.
8. The apparatus of claim 1, wherein the control circuit comprises a controller module, a power supply module, and a wireless communication module, the controller module is coupled to the wireless communication module and the suction pump, and the power supply module provides power to the apparatus.
9. The apparatus of claim 8, wherein the controller module comprises a single-chip or an ARM chip.
10. A interstitial fluid detection system, comprising a user terminal and a device according to any one of claims 1-9.
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