Contact lens tear glucose sensor monitoring system

Abstract

The present application provides a kind of contact lens type tear glucose sensing monitoring system, comprising: substrate, the substrate is made of flexible transparent material;Bionic microfluid channel sample collection module, the bionic microfluid channel sample collection module is used to collect tear fluid;Tear glucose monitoring sensor, the tear glucose monitoring sensor is used to detect the glucose content in tear fluid, the tear glucose monitoring sensor is connected with the bionic microfluid channel sample collection module;Wireless signal transmission module, the wireless signal transmission module is connected with the tear glucose monitoring sensor;Contact lens external circuit module, the contact lens external circuit module is used to receive the detection result signal transmitted by the wireless signal transmission module;The bionic microfluid channel sample collection module, the tear glucose monitoring sensor and the wireless signal transmission module are all arranged on the substrate. Can improve the security, comfort and portability of eye physiological information monitoring.

Description

Technical Field

[0001] This invention relates to the field of biomedical device technology, and in particular to a contact lens-type tear glucose sensing and monitoring system. Background Technology

[0002] Currently, medical diagnostic technology is gradually evolving from simply improving diagnostic accuracy to enhancing treatment safety, patient comfort, and diagnostic convenience. Miniature wearable medical monitoring systems, with their ability to provide portable and continuous monitoring of vital signs (such as body temperature, nerve signals, and bodily fluid chemical signals), hold great promise for home-based safe care of recovering patients and timely diagnosis and screening of high-risk individuals. Selecting the most appropriate human physiological information as a reliable basis for medical diagnosis is the core issue of miniature wearable medical monitoring systems.

[0003] Ocular physiological information is receiving increasing attention as an effective diagnostic tool for various diseases. To protect the body from harm, physiological information such as bodily fluids and neural networks is blocked by dense skin. Diagnostic methods involving skin punctures can cause trauma and discomfort to patients, and even carry risks of infection and irreversible damage. Therefore, the reliability of obtaining chemical and electrical physiological information outside the epidermis is insufficient. However, the eye, due to its constant tear film lubrication and the small gap between the retina and the external environment, allows for convenient and reliable acquisition of chemical and electrical physiological information. Furthermore, as vision is one of the most important senses for human cognition, the effective prevention and treatment of eye diseases are of great significance.

[0004] In existing technologies, wearable ocular physiological information medical monitoring systems include diabetes diagnostic systems based on tear blood glucose monitoring, glaucoma diagnostic systems based on intraocular pressure monitoring, neurological disease diagnostic systems based on ocular nerve signal monitoring, and retinal disease detection systems based on electroretinography. Among these, the tear blood glucose monitoring-based diabetes diagnostic system achieves non-invasive and continuous blood glucose monitoring compared to traditional blood test-based methods; the intraocular pressure monitoring-based glaucoma diagnostic system achieves portability and timeliness of intraocular pressure monitoring compared to traditional large-scale applanation tonometers. However, in existing technologies, exporting ocular physiological information to the outside world mainly includes two methods: directly connecting the ocular sensing circuit to external measuring instruments via wired connection and using wireless transmission chips for transmission. Wired ocular physiological information monitoring cannot meet the safety, comfort, and portability requirements for patient use, while the wireless transmission chip's package thickness is too large, failing to meet the requirement of 50-100μm after embedding in contact lenses, causing discomfort for patients and potentially causing eye damage during blinking. Furthermore, to meet requirements such as fitting the eyeball and not affecting the user's vision, the system needs to be flexible and transparent. Key issues regarding the practicality of ocular physiological information medical monitoring systems remain.

[0005] Therefore, developing a safe, comfortable, and convenient continuous ocular physiological information monitoring system is crucial for real-time measurement of ocular physiological information and intelligent ocular medical diagnosis. Summary of the Invention

[0006] This invention provides a contact lens-type tear glucose sensing and monitoring system to address the technical shortcomings of existing ocular physiological information monitoring systems, which suffer from poor safety, comfort, and portability, thereby improving the safety, comfort, and portability of ocular physiological information monitoring.

[0007] This invention provides a contact lens-type tear glucose sensing and monitoring system, comprising:

[0008] Substrate, wherein the substrate is made of a flexible transparent material;

[0009] A biomimetic microfluidic sample acquisition module is used to collect tears and isolate the tear glucose monitoring sensor from the outside world to reduce interference.

[0010] A tear glucose monitoring sensor is used to detect the glucose content in tears, and the tear glucose monitoring sensor is connected to the biomimetic microchannel sample acquisition module;

[0011] A wireless signal transmission module, wherein the wireless signal transmission module is connected to the tear glucose monitoring sensor;

[0012] The contact lens external circuit module is used to receive the detection result signal transmitted by the wireless signal transmission module;

[0013] The biomimetic microfluidic sample acquisition module, the tear glucose monitoring sensor, and the wireless signal transmission module are all mounted on the substrate.

[0014] According to the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the biomimetic microfluidic sample acquisition module includes a pumping chamber, and an inlet channel and an outlet channel are respectively provided on both sides of the pumping chamber.

[0015] According to the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the pumping chamber can naturally reset itself without external force after being compressed.

[0016] According to the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the inlet channel and the outlet channel are provided with valve structures arranged in the direction from the inlet channel to the outlet channel. The valve structures are used to prevent the tears in the biomimetic microfluidic sample acquisition module from flowing from the outlet channel to the inlet channel.

[0017] According to the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the thickness of the valve structure gradually increases along the direction from the inlet channel to the outlet channel.

[0018] According to the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the microchannel wall thickness of the biomimetic microchannel sample acquisition module is 10μm to 1mm.

[0019] According to the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the tear glucose monitoring sensor includes a graphene-based sensor.

[0020] According to the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the contact lens external circuit module includes a radio frequency receiving coil, an analog-to-digital conversion circuit, and a receiving terminal.

[0021] According to the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the receiving terminal includes a mobile phone, a computer, or an oscilloscope.

[0022] In the contact lens-type tear glucose sensing and monitoring system provided by the present invention, the thickness of the substrate is 0.2 μm to 5 mm.

[0023] The contact lens-type tear glucose sensing and monitoring system provided by this invention involves installing a substrate in the eye, and a biomimetic microfluidic sample acquisition module sending the collected tear fluid to a tear glucose monitoring sensor to detect the glucose content in the tear fluid. The detection result is transmitted to the contact lens external circuit module via a wireless signal transmission module. Combined with the correlation between tear fluid and blood components, continuous non-invasive glucose monitoring can be achieved. This solves the technical defects of existing eye physiological information monitoring systems, which have poor safety, comfort, and portability, and improves the safety, comfort, and portability of eye physiological information monitoring. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0025] Figure 1 This is a schematic diagram of an embodiment of the contact lens-type tear glucose sensing and monitoring system provided by the present invention;

[0026] Figure 2 This is a schematic diagram of an embodiment of the contact lens-type tear glucose sensing and monitoring system provided by the present invention (hiding the external circuit module of the contact lens);

[0027] Figure 3 This is a schematic diagram of the structure of the biomimetic microfluidic sample acquisition module in the contact lens-type tear glucose sensing and monitoring system provided by the present invention;

[0028] Figure 4 This is a schematic diagram of the internal liquid flow in the biomimetic microchannel sample acquisition module of the contact lens-type tear glucose sensing and monitoring system provided by the present invention.

[0029] Figure 5 This is a schematic diagram of the overall structure of the biomimetic microfluidic sample acquisition module in the contact lens-type tear glucose sensing and monitoring system provided by the present invention.

[0030] Figure 6 This is a schematic diagram of the response of a graphene field-effect transistor to glucose concentration;

[0031] Figure 7 This is a Raman spectroscopy characterization result of graphene during the fabrication process of the graphene-based sensor;

[0032] Figure 8 This is a flowchart illustrating the preparation process of the contact lens-type tear glucose sensing and monitoring system provided by the present invention.

[0033] Figure 9 This is the equivalent circuit diagram of the contact lens-type tear glucose sensing and monitoring system provided by the present invention during wireless measurement;

[0034] Figure 10 This is a schematic diagram of the structure of the contact lens-type tear glucose sensing and monitoring system provided by the present invention integrated into a framed glasses-type portable device;

[0035] Figure 11 This is a flowchart of the working process of the contact lens-type tear glucose sensing and monitoring system provided by the present invention.

[0036] Figure label:

[0037] 1. Substrate; 2. Bionic microfluidic sample acquisition module; 201. Pumping chamber; 202. Liquid inlet channel; 203. Liquid outlet channel; 204. Valve structure; 3. Tear glucose monitoring sensor; 4. Wireless signal transmission module; 5. Contact lens external circuit module. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0039] The following is combined with Figures 1-11 This invention describes a contact lens-type tear glucose sensing and monitoring system.

[0040] like Figure 1 The diagram shown is a schematic representation of an embodiment of the contact lens-type tear glucose sensing and monitoring system provided by the present invention. This embodiment of the contact lens-type tear glucose sensing and monitoring system includes:

[0041] Substrate 1 is made of a flexible transparent material. The thickness of substrate 1 is 0.2 μm to 5 mm. The substrate 1 material should also possess good air permeability and light transmittance, and be a biocompatible thin-film polymer material. In this embodiment, the material can be polyimide (PI), polyethylene terephthalate (PET), polyetherimide (PEI), polylactic acid (PLA), or other polymer materials with similar properties. Alternatively, substrate 1 can be a material with a low Young's modulus, such as PDMS, with a modulus between 0.1 MPa and 100 MPa. A substrate 1 with a higher Young's modulus but thinned can also be selected, such as PET, PI, PVA, or other polymer materials with a thickness of 1 μm to 100 μm. In this case, the characteristic is a smaller moment of inertia, ranging from 1*10⁻⁶. -10 cm 4 ~1*10 -6 cm 4 Meanwhile, to ensure the sensor does not interfere with normal visual function, its light transmittance should be above 80%. Substrate 1 can also be assembled from multiple layers of different structures stacked together. The circuitry and other components of the contact lens will be built on this substrate.

[0042] The biomimetic microfluidic sample acquisition module 2 is used to collect tears and isolate the tear glucose sensor from the outside world to reduce interference and improve service life.

[0043] Tear glucose monitoring sensor 3 is used to detect the glucose content in tears. Tear glucose monitoring sensor 3 is connected to biomimetic microfluidic sample acquisition module 2.

[0044] A wireless signal transmission module 4 is connected to the tear glucose monitoring sensor 3. In this embodiment, the wireless signal transmission module 4 includes a coil connected in series with the tear glucose monitoring sensor 3. A resistor or inductor may be connected in series with the coil. The coil may not be closed, employing an air capacitor design.

[0045] The external circuit module 5 for contact lenses is used to receive the detection result signal transmitted by the wireless signal transmission module 4. It should be noted that the coil of the external circuit can also be combined with eyeglasses or made into a separate coil for use, such as... Figure 10 As shown.

[0046] The biomimetic microfluidic sample acquisition module 2, the tear glucose monitoring sensor 3, and the wireless signal transmission module 4 are all mounted on the substrate 1. They can be fabricated via photolithography, sputtering, direct printing, or pattern transfer.

[0047] like Figures 3-5 As shown, in this embodiment, the biomimetic microfluidic sample acquisition module 2 includes a pumping chamber 201. An inlet channel 202 and an outlet channel 203 are respectively provided on both sides of the pumping chamber 201. The outlet channel 203 is connected to a graphene-based sensor. In use, tears enter the pumping chamber 201 through the inlet channel 202 and then reach the tear glucose monitoring sensor 3 for detection through the outlet channel 203. Of course, in some embodiments, the graphene-based sensor portion can be directly fabricated on the sidewall or bottom of the biomimetic microfluidic sample acquisition module 2.

[0048] In this embodiment, the pumping chamber 201, after being compressed, can naturally return to its original position without external force. During use, the user applies pressure to the pumping chamber 201 using natural processes such as blinking. Blinking causes the pumping chamber 201 to contract, and when the eyes open, the pumping chamber 201 naturally returns to its original position without the pressure exerted by the eyelids, creating a suction effect on the tear fluid, thus achieving tear fluid sampling without an additional power source. Furthermore, this flow channel structure prevents direct contact between the sensor's sensitive element and the conjunctiva of the eye or the external environment, thereby reducing element wear and interference from other external factors. Its simple structure, by avoiding direct contact between the sensitive part and the outside world and constraining the analyte into a fixed three-dimensional structure, significantly improves signal quality.

[0049] like Figure 4 and Figure 5 As shown, in this embodiment, the inlet channel 202 and the outlet channel 203 are provided with valve structures 204 arranged in the direction from the inlet channel 202 to the outlet channel 203. The valve structures 204 are used to prevent tear fluid in the biomimetic microfluidic sample acquisition module 2 from flowing from the outlet channel 203 to the inlet channel 202. Tear fluid can only pass through when there is positive pressure on one side of the fixed valve structure 204 and negative pressure on the other side. This is because the valve structures 204, made of materials with low Young's modulus (0.1MPa~100MPa), will bend and collide with each other under the opposite pressure to form a relatively stable structure that prevents liquid flow. Figure 5The overall structure of the biomimetic microfluidic sample acquisition module 2 is shown. This structure includes two unidirectional inlet channels 202 and outlet channels 203, each with a valve structure 204. This unidirectional arrangement of the valve channels ensures unidirectional liquid flow when the central pumping chamber 201 is compressed and pressure is generated. Specifically, the valve structure 204 can consist of 2 to 10 valves that can close under pressure. This valve enables self-driven sampling without requiring external energy supply.

[0050] like Figure 5 As shown, in this embodiment, the thickness of the valve structure 204 gradually decreases along the direction from the inlet channel 202 to the outlet channel 203, with the thickness varying from 10 to 100 μm. This range allows the valve structure 204 to deform under a certain pressure gradient, but maintains a certain rigidity under some pressure gradients to prevent liquid from passing through.

[0051] In this embodiment, the microchannel wall thickness of the biomimetic microchannel sample acquisition module 2 is 10 μm to 1 mm. This range ensures that the device can easily deform within the intraocular pressure range.

[0052] In this embodiment, the tear glucose monitoring sensor 3 is a graphene-based sensor. Specifically, it includes sensors that achieve detection by immobilizing aptamers on the graphene surface using different methods. Methods for immobilizing aptamers include disrupting the perfect graphene structure to generate free bonds, thereby achieving covalent cross-linking on its surface, or functionalizing the graphene surface through non-covalent interactions. In terms of operating modes, the graphene-based sensor can directly apply a potential across its terminals to detect the analyte concentration in a resistive manner, or it can add a gate to detect the analyte using a graphene field-effect transistor.

[0053] Graphene-based sensors can operate in either field-effect transistor (FET) or resistive mode. Their principle is based on immobilizing aptamers on the graphene surface that specifically bind to the analyte. These aptamers include, but are not limited to, antibodies, affinity adsorption, chemical reactions, and other molecules capable of physical binding or chemical reactions with the analyte molecules. Due to graphene's two-dimensional material properties, the binding of these aptamers to the analyte molecules alters the graphene's electrical parameters, thereby achieving detection. Analyte molecules include glucose, albumin, lysozyme, immunoglobulins, hormones, and inorganic ions, among other tear components. Specifically, the response range for glucose is 0.1 μmol / L to 5 mmol / L. The graphene in graphene-based sensors can be single-layered to 10-layered.

[0054] like Figure 6 As shown in the attached figure, the sensitive part of the graphene-based sensor, namely the graphene field-effect transistor, responds to different concentrations of glucose. Figure 7 The results show the Raman spectroscopy characterization of graphene during the fabrication of the graphene-based sensor.

[0055] It should be noted that the three parts of the tear glucose monitoring sensor can utilize low-dimensional materials such as organically modified graphene, molybdenum disulfide, carbon nanotubes, and silver nanowires, or thin-layer gel-like substances. In principle, it can be a resistive or capacitive biosensor, meaning a sensor whose resistance or capacitance changes with the concentration of the analyte.

[0056] In this embodiment, the external circuit module 5 of the contact lens includes a radio frequency receiving coil, an analog-to-digital conversion circuit, and a receiving terminal. The resonant frequency of the radio frequency coil and the wireless signal transmission module 4 on the contact lens is between 10MHz and 10GHz, and can be received by a receiving terminal device. The receiving terminal includes a mobile phone, a computer, or an oscilloscope.

[0057] like Figure 8 The diagram shown is a flowchart illustrating the fabrication process of the contact lens-type tear glucose sensing and monitoring system in this embodiment.

[0058] like Figure 9 The diagram shown is an equivalent circuit diagram of the contact lens-type tear glucose sensing and monitoring system provided by the present invention during wireless measurement.

[0059] The following is a detailed description of the workflow of the contact lens-type tear glucose sensing and monitoring system in this embodiment. Please refer to the appendix. Figure 11 .

[0060] Substrate preservation: Before use, the substrate 1, which is equipped with the biomimetic microfluidic sample acquisition module 2, tear glucose monitoring sensor 3 and wireless signal transmission module 4, can be immersed in the preservation solution, or the substrate 1 can be kept dry to maintain the activity of the sensor's sensitive part.

[0061] Substrate wearing: The method of wearing this substrate 1 is similar to that of wearing existing commercial contact lenses;

[0062] System startup: The system may require a startup time to reach signal stability, which can range from 5 minutes to 1 hour. However, in some cases, startup time may not be required, and the sensor can output a signal immediately. The startup time mainly depends on the rate at which the tear film wets the sensor.

[0063] External circuit excitation: Signal transmission relies on excitation feedback applied by the contact lens external circuit module 5. The external circuit module 5 excites the tear glucose monitoring sensor 3 through changes in the electric field. The tear glucose monitoring sensor 3 exhibits different resistances at different glucose concentrations, thus responding differently to the excitation signal. This response is read by the external circuit, thereby achieving signal transmission. The frequency of the magnetic field generated by the contact lens external circuit module 5 is between 1MHz and 10GHz. The signal is transmitted as an analog signal and preprocessed in a device coupled to the external circuit. This processing includes, but is not limited to, filtering, amplification, analog-to-digital conversion, and Fourier decomposition.

[0064] The blood glucose concentration is obtained by fitting the data after preprocessing with the data from previous experiments. The fitting can be achieved by using a neural network to fit different functions as needed.

[0065] As can be seen from the above description of the embodiments, the contact lens-type tear glucose sensing and monitoring system provided by the present invention has the following advantages:

[0066] In use, the substrate is installed in the eye, and the biomimetic microfluidic sample collection module sends the collected tear fluid to the tear glucose monitoring sensor to detect the glucose content in the tear fluid. The detection result is transmitted to the contact lens external circuit module through the wireless signal transmission module. Combined with the correlation between tear fluid and blood components, continuous non-invasive glucose monitoring can be achieved. This solves the technical defects of existing eye physiological information monitoring systems, which are poor in terms of safety, comfort and portability, and improves the safety, comfort and portability of eye physiological information monitoring.

[0067] This invention employs a graphene-based sensor to detect glucose in tears. Because two-dimensional materials like graphene can sensitively sense changes in the external environment, and can be coupled with specific aptamers to enhance sensitivity and specificity. The graphene-based sensor in this invention can operate as a field-effect transistor or in resistive mode, thereby reducing the difficulty of subsequent data transmission.

[0068] This invention provides a wireless signal transmission system for contact lenses, comprising an external circuit for the contact lens. It discloses two subsystems: the wireless signal transmission system for contact lenses and the external circuit for contact lenses. This achieves chip-free and distance-insensitive transmission of the resistance value of a graphene resistive sensor to the outside world.

[0069] In the contact lens-type tear glucose sensing and monitoring system provided by this invention, the flexible coil can be integrated with a flexible substrate and commercial contact lenses.

[0070] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A contact lens type tear glucose sensing monitoring system, characterized by, The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device.

2. The contact lens tear glucose sensor monitoring system of claim 1, wherein, The application relates to a contact lens-based glucose monitoring device.

3. The contact lens tear glucose sensor monitoring system of claim 1, wherein, The application relates to a contact lens-based glucose monitoring device.

4. The contact lens tear glucose sensor monitoring system of any one of claims 1-3, wherein, The application relates to a contact lens-based glucose monitoring device.

5. The contact lens tear glucose sensor monitoring system of any one of claims 1-3, wherein, The application relates to a contact lens-based glucose monitoring device.

6. The contact lens tear glucose sensor monitoring system of claim 5, wherein, The application relates to a contact lens-based glucose monitoring device.

7. The contact lens tear fluid glucose sensor monitoring system of any one of claims 1-3, wherein, The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. The application relates to a contact lens-based glucose monitoring device. 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