A glaucoma drainage device capable of monitoring intraocular pressure and its application method

Abstract

The present invention discloses a glaucoma drainage device capable of monitoring intraocular pressure and its application method, belonging to the technical field of intraocular pressure monitoring and drainage. It includes a device body, a drainage tube, a pressure-sensitive element, and a dual-line coupled antenna. The drainage tube is communicated with the inlet of the device body and is used to lead the aqueous humor out to the device body and diffuse it to the surrounding tissues of the eye through the device body. The pressure-sensitive element is formed by face-to-face laminating conductive composite films with microstructures to construct a pressure-sensitive element with an interlocking structure. The dual-line coupled antenna includes two flexible substrates with metal coils on their surfaces. After the flexible substrates are stacked face-to-face and overlapped, the straight pins of the two metal coils are exposed. One straight pin is connected to a conductive composite film with microstructures. One of the flexible substrates of the dual-line coupled antenna is adhered to the device body or embedded inside the device body by using a biocompatible material. The pressure-sensitive element can also be adhered to the device body or embedded inside the device body.

Description

Technical Field

[0001] The present invention belongs to the technical field of pressure monitoring and drainage, and particularly relates to a glaucoma drainage device capable of monitoring intraocular pressure and an application method thereof. Background Art

[0002] When the intraocular pressure of a patient is difficult to control with medication, a glaucoma drainage device needs to be implanted to divert the aqueous humor in the eye, thereby reducing the intraocular pressure. Although the existing glaucoma drainage devices can effectively drain the aqueous humor, they cannot monitor the intraocular pressure in real time, that is, "only drain without monitoring". Thus, it will not be convenient to timely grasp the data of the patient's intraocular pressure, and the timeliness of intraocular pressure monitoring is particularly important for doctors' medical record analysis and determination of treatment plans. When the increased intraocular pressure of a patient is not monitored and controlled in time, it is easy to miss the best treatment time, resulting in delayed illness, aggravated irreversible glaucoma optic nerve damage, and relatively high blindness, affecting the treatment effect, which will greatly increase the social and economic burden.

[0003] Although there are experimental studies on intraocular pressure monitoring devices implanted in the eye, however, they can only achieve intraocular pressure monitoring and have no function of draining aqueous humor, that is, "only monitor without draining", and the technology is immature, the risk is high and there is no clinical application.

[0004] In view of the urgent need for timely, accurate, and long-term monitoring and control of intraocular pressure in glaucoma treatment, which is closely related to the prognosis of patients, and currently there is no device that has both the function of draining and real-time monitoring of intraocular pressure. Therefore, there is an urgent need to propose a glaucoma drainage device capable of monitoring intraocular pressure, which also has the functions of real-time, accurate, and long-term monitoring of intraocular pressure, as well as draining aqueous humor and reducing intraocular pressure, that is, "both monitor and drain". Summary of the Invention

[0005] The purpose of the present invention is to provide a glaucoma drainage device capable of monitoring intraocular pressure and reducing intraocular pressure, as well as an application method thereof.

[0006] To achieve the above purpose, the present invention provides the following technical solutions:

[0007] In the first aspect, the present invention provides a glaucoma drainage device capable of monitoring intraocular pressure, comprising:

[0008] A device body,

[0009] A drainage tube, which is communicated with the inlet of the device body and is used for leading the aqueous humor out to the device body and diffusing it to the surrounding tissues of the eye through the device body;

[0010] A pressure-sensitive element, which is constructed by face-to-face laminating conductive composite films with microstructures to form a pressure-sensitive element with an interlocking structure;

[0011] A dual-line coupled antenna, which includes two flexible substrates with metal coils on their surfaces. After the flexible substrates are stacked face to face and up and down, the straight pins of the two metal coils are exposed, and one straight pin is connected to a conductive composite film with microstructures. One of the flexible substrates of the dual-line coupled antenna is adhered to the device body using a biocompatible material, or embedded inside the device body.

[0012] As a possible implementation, when the pressure is less than 24 mmHg, the number of contact points and the fitting area of the conductive composite film with microstructures make the resistance value of the pressure-sensitive element the largest.

[0013] When the pressure is greater than or equal to 24 mmHg and the duration is greater than the preset time (1 hour), the number of contact points and the fitting area of the conductive composite film with microstructures increase, making the resistance value of the pressure-sensitive element gradually decrease from the maximum value to the minimum value. During the process of the resistance value gradually changing from the maximum value to the minimum value, the dual-line coupled antenna outputs a sine wave, and the sine wave is used to drive the alarm device communicating with the glaucoma drainage device to sound.

[0014] As a possible implementation, the dual-line coupled antenna also has a wireless communication function and is communicatively connected to the single-chip microcomputer subsystem. The single-chip microcomputer subsystem receives the resistance value change of the pressure-sensitive element, converts the resistance value change into an electrical pressure signal, and further extracts the characteristics of the electrical pressure signal and then outputs it to an oscilloscope or stores it in a database.

[0015] As a possible implementation, the polymer matrix used for the conductive composite film with microstructures is polydimethylsiloxane or polyimide or polyester.

[0016] The conductive fillers used for the conductive composite film with microstructures include carbon nanotubes, graphene, or metal nanoparticles.

[0017] The metal coils included in the dual-line coupled antenna are metal thin films, conductive polymers, or carbon-based materials.

[0018] As a possible implementation, the dual-line coupled antenna and the pressure-sensitive element are encapsulated in the device body in an embedded packaging manner. Specifically, a parylene protective layer is formed on the surface of the metal coil using a chemical vapor deposition process; the two metal coils are encapsulated using polydimethylsiloxane; the pressure-sensitive element is encapsulated using a medical biomaterial; after being embedded in the device body, the metal coil with a reading function is communicatively connected to the single-chip microcomputer subsystem.

[0019] As a possible implementation, two conductive composite films with microstructures are attached to the inner surface or the outer surface of the device body, one on top and the other at the bottom.

[0020] As a possible implementation, the cavity of the device body is a trapezoidal valve body cavity to form a Venturi effect; the material of the device body is medical silicone; the device body is in a gradually narrowing shape, and the thickness of the leading edge is 0.3 mm; two support ridges are symmetrically arranged on the device body in the direction from the leading edge to the drainage tube; filter holes are provided at the position between the leading edge and the drainage tube of the device body.

[0021] In a second aspect, the present invention provides another glaucoma drainage device capable of monitoring intraocular pressure, including:

[0022] A device body,

[0023] A drainage tube, which is communicated with the inlet of the device body and is used for leading aqueous humor into the device body and diffusing it to the surrounding tissues of the eye through the device body;

[0024] A pressure-sensitive element, and the pressure-sensitive element is a piezocapacitive flexible sensor for a liquid environment;

[0025] A dual-line coupled antenna, which includes two flexible substrates with metal coils on the surfaces. After the flexible substrates are stacked face to face up and down, the straight pins of the two metal coils are exposed, and one straight pin is connected to the capacitor plate of a piezocapacitive flexible sensor for a liquid environment; one of the flexible substrates of the dual-line coupled antenna is adhered to the device body by using a biocompatible material, or is embedded inside the device body.

[0026] As a possible implementation, the material of the dielectric included in the piezocapacitive flexible sensor for a liquid environment is polydimethylsiloxane or polypyrrole; the dielectric has a variety of microstructures, and the variety of microstructures at least includes one or several of triangle, cylinder or sphere.

[0027] In a third aspect, the present invention further provides an application method of a glaucoma drainage device capable of monitoring intraocular pressure. The glaucoma drainage device capable of monitoring intraocular pressure is the glaucoma drainage device capable of monitoring intraocular pressure described in the first aspect, or is the glaucoma drainage device capable of monitoring intraocular pressure described in the second aspect; the glaucoma drainage device capable of monitoring intraocular pressure integrated with a pressure-sensitive element is implanted into the body once, and at the same time, the functions of reducing intraocular pressure and monitoring intraocular pressure are realized.

[0028] Compared with the prior art, the present invention has the following effects:

[0029] 1. The glaucoma drainage device capable of monitoring intraocular pressure provided by the present invention combines the device for monitoring intraocular pressure with the intraocular fluid drainage device to form an integral whole. Through one implantation surgery, that is, without increasing the number of surgeries, without increasing surgical trauma, and without increasing the pain of patients, it can not only realize real-time continuous monitoring of eye pressure, but also realize the function of draining intraocular fluid and controlling intraocular pressure. It greatly improves the prognosis of patients and the control of glaucoma, and benefits the patients.

[0030] 2. By applying the glaucoma drainage device capable of monitoring intraocular pressure provided by the present invention, patients can achieve long-term, real-time, and continuous intraocular pressure monitoring by themselves, and it is also applicable to patients who cannot measure intraocular pressure with existing instruments. For example, patients after artificial corneal implantation or with severe corneal diseases. Moreover, patients can monitor their intraocular pressure by themselves without going to a medical institution, providing objective and accurate intraocular pressure data for doctors and realizing telemedicine.

[0031] 3. The pressure-sensitive element used in the glaucoma drainage device capable of monitoring intraocular pressure provided by the present invention is a resistive pressure sensor. Due to the adoption of a microstructural design and a conductive composite thin film material, the resistive pressure sensor shows extremely high precision in intraocular pressure monitoring. This helps doctors understand the intraocular pressure data of patients more accurately, providing a reliable basis for doctors to timely understand the patient's condition and formulate treatment plans. The introduction of the microstructure enables the sensor to generate obvious resistance changes even for tiny pressure changes, thereby improving the sensitivity of the sensor. The conductive composite thin film material usually has good biocompatibility and can work stably in the intraocular environment for a long time without causing adverse effects on the body.

[0032] 4. The pressure-sensitive element used in the glaucoma drainage device capable of monitoring intraocular pressure provided by the present invention can also be a piezocapacitive flexible sensor for liquid environments, which has the advantages of high sensitivity, flexible bendability, good biocompatibility, easy integration and miniaturization, real-time monitoring and feedback, as well as durability and stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 It is a schematic structural diagram of the pressure-sensitive element provided by an embodiment of the present invention;

[0034] Figure 2 It is a schematic structural diagram of the two-wire coupled antenna provided by an embodiment of the present invention;

[0035] Figure 3 It is a schematic structural diagram of the piezocapacitive flexible sensor for liquid environments provided by an embodiment of the present invention;

[0036] Figure 4 It is a schematic structural diagram of another two-wire coupled antenna provided by an embodiment of the present invention.

[0037] REFERENCE SIGNS:

[0038] 10 - Conductive composite thin film;

[0039] 20 - Flexible substrate, 21 - Metal coil, 210 - Straight pin;

[0040] 30 - Capacitor plate, 31 - Dielectric. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0041] In order to clearly describe the technical solutions of the embodiments of the present invention, in the embodiments of the present invention, terms such as "first" and "second" are used to distinguish identical or similar items with basically the same functions and effects. For example, the first threshold and the second threshold are only used to distinguish different thresholds, and do not limit their order. Those skilled in the art can understand that terms such as "first" and "second" do not limit the quantity and execution order, and terms such as "first" and "second" do not necessarily limit being different from each other.

[0042] It should be noted that in the present invention, words such as "exemplary" or "for example" are used to indicate examples, illustrations or explanations. Any embodiment or design solution described as "exemplary" or "for example" in the present invention should not be construed as being more preferred or having more advantages than other embodiments or design solutions. Exactly speaking, using words such as "exemplary" or "for example" aims to present relevant concepts in a specific manner.

[0043] In the present invention, "at least one" means one or more, and "a plurality" means two or more. "And / or" describes the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone, where A and B can be singular or plural. The character " / " generally indicates that the associated objects before and after are in an "or" relationship. "At least one (item)" or its similar expression below refers to any combination of these items, including any combination of single item (item) or plural items (items). For example, at least one (item) of a, b or c can represent: a, b, c, the combination of a and b, the combination of a and c, the combination of b and c, or the combination of a, b and c, where a, b and c can be single or multiple.

[0044] See Figure 1 and Figure 2 , an embodiment of the present invention provides a glaucoma drainage device capable of monitoring intraocular pressure, including: a device body (not shown in the figure), a drainage tube, a pressure-sensitive element and a dual-line coupled antenna. The drainage tube is communicated with the inlet of the device body and is used to lead aqueous humor out to the device body and diffuse to the surrounding tissues of the eye through the device body. The pressure-sensitive element is formed by face-to-face laminating a conductive composite film 10 with microstructures to construct a pressure-sensitive element with an interlocking structure. The dual-line coupled antenna includes two flexible substrates 20 with metal coils 21 on their surfaces. After the flexible substrates 20 are stacked face-to-face up and down, the straight pins 210 of the two metal coils 21 are exposed. One straight pin 210 is connected to a conductive composite film 10 with microstructures. One of the flexible substrates 20 of the dual-line coupled antenna is adhered to the device body using a biocompatible material, or embedded inside the device body. The pressure-sensitive element can also be adhered to the device body or embedded inside the device body.

[0045] In actual applications, the device for monitoring intraocular pressure is combined with the intraocular fluid drainage device to form a whole. Through a single implantation operation, it can not only realize real-time continuous monitoring of intraocular pressure, but also drain intraocular fluid and control intraocular pressure. Moreover, patients can realize long-term, real-time and continuous intraocular pressure monitoring by themselves. It is also suitable for patients who cannot measure intraocular pressure with existing instruments, such as patients after artificial cornea implantation or with severe corneal lesions. Moreover, patients can monitor their intraocular pressure by themselves without going to a medical institution, providing doctors with objective and accurate intraocular pressure data and realizing telemedicine.

[0046] The cavity of the device body is a trapezoidal valve body cavity to form a Venturi effect. The material of the device body is medical silicone. The device body is gradually narrowed and thin, and the thickness of the front edge is 0.3mm. The device body is symmetrically provided with two supporting ridges from the front edge to the drainage tube. The device body is provided with a filtering hole at a position between the front edge and the drainage tube.

[0047] The polymer matrix used in the conductive composite film 20 with a microstructure is polydimethylsiloxane or polyimide or polyester. The conductive filler used in the conductive composite film 20 with a microstructure includes carbon nanotubes, graphene or metal nanoparticles. Due to the use of microstructure design and conductive composite film materials, the resistive pressure sensor shows extremely high accuracy in intraocular pressure monitoring. This helps doctors understand the patient's intraocular pressure data more accurately, and provides a reliable basis for doctors to understand the patient's condition in a timely manner and provide treatment plans. The introduction of the microstructure enables the sensor to produce obvious resistance changes even for slight pressure changes, thereby improving the sensitivity of the sensor. Conductive composite film materials usually have good biocompatibility, can work stably for a long time in the intraocular environment, and will not cause adverse effects on the body.

[0048] The bidirectional coupling antenna also has a wireless communication function, which is connected to the single-chip microcomputer subsystem, and the single-chip microcomputer subsystem receives the resistance change of the pressure sensitive element and converts the resistance change into an electrical pressure signal, and further extracts the characteristics of the electrical pressure signal and outputs it to the oscilloscope or stores it in a database. The metal coil 21 included in the two-wire coupling antenna is a metal film, a conductive polymer or a carbon-based material.

[0049] The dual-wire coupling antenna and the pressure sensitive element are embedded in the device body in an embedded packaging manner, specifically including:

[0050] S10. A Parylene protective layer is formed on the surface of the metal coil by a vapor deposition process. The Parylene protective layer is a protective polymer material, also known as polyparaxylene, which has excellent electrical insulation and protection properties.

[0051] S11. Encapsulate two metal coils using polydimethylsiloxane (PDMS).

[0052] S12. Encapsulate the pressure - sensitive element using medical biomaterials.

[0053] S13. After a pressure - sensitive element is connected to a straight pin included in a double - wire coupled antenna and then embedded into the device body, communicate the metal coil with a reading function to the microcontroller subsystem.

[0054] When the pressure is less than 24 mmHg, the number of contact points and the contact area of the conductive composite film with microstructures result in the maximum resistance value of the pressure - sensitive element; when the pressure is greater than or equal to 24 mmHg and the duration is greater than the preset time (1 hour), the number of contact points and the contact area of the conductive composite film with microstructures increase, causing the resistance value of the pressure - sensitive element to gradually decrease from the maximum value to the minimum value. During the process of the resistance value gradually changing from the maximum value to the minimum value, the double - wire coupled antenna outputs a sine wave, and the sine wave is used to drive an alarm device that communicates with the glaucoma drainage device to sound.

[0055] In a second aspect, referring to Figure 3 and Figure 4 , the embodiments of the present invention further provide another glaucoma drainage device capable of monitoring intraocular pressure, including: a device body, a drainage tube, which is communicated with the inlet of the device body and is used to lead aqueous humor into the device body and diffuse it to the surrounding tissues of the eye through the device body; a pressure - sensitive element, where the pressure - sensitive element is a capacitive liquid - environment flexible sensor; a double - wire coupled antenna, which includes two flexible substrates with metal coils on their surfaces. After the flexible substrates are stacked face - to - face and the straight pins of the two metal coils are exposed, one straight pin is connected to the capacitor plate of a capacitive liquid - environment flexible sensor; one of the flexible substrates of the double - wire coupled antenna is adhered to the device body using a biocompatible material or embedded inside the device body.

[0056] The capacitive liquid - environment flexible sensor has the advantages of high sensitivity, flexible bendability, good biocompatibility, easy integration and miniaturization, real - time monitoring and feedback, and durability and stability.

[0057] The capacitive liquid - environment flexible sensor is formed by a capacitor plate 30 and a dielectric 31. Among them, the dielectric 31 is preferably made of a flexible material. When the intraocular pressure increases, the dielectric 31 gradually approaches the capacitor plate 30 and deforms after contacting the capacitor plate 30, thereby causing a change in the distance between the capacitor plates 30 or the contact area of the capacitor plates 30. The change in the distance or contact area of the capacitor plates 30 will cause a change in the capacitance value. It can be obtained from the formula that

[0058]

[0059] Among them, C can represent the capacitance value, d can represent the distance between the two capacitor plates 30, S can represent the facing area or the contact area of the two capacitor plates 30, ε0, ε r can represent the dielectric constant of the dielectric 31 between the two capacitor plates 30.

[0060] The material of the dielectric 31 is polydimethylsiloxane or polypyrrole; thus avoiding adverse reactions such as rejection and infection. The dielectric 31 has a variety of microstructures, and the variety of microstructures includes at least one or several of triangular, cylindrical or spherical. Preferably, the microstructure of the dielectric 31 is pyramid-shaped, thereby improving the sensitivity of the capacitive pressure sensing module.

[0061] The dual-line coupled antenna in the glaucoma drainage device capable of monitoring intraocular pressure provided by the first and second aspects realizes wireless power supply and wireless communication based on the LC resonance circuit principle. Most wearable medical devices are powered by batteries, which brings inconvenience to patient safety and mobility. Batteries have chemical side effects and limited usage time. In contrast, the wireless transmission technology based on the LC resonance circuit is safer and can replace wired equipment to provide signal communication and energy transmission.

[0062] The entire induction system framework is constructed based on the LC circuit. When designing, first use HFSS electromagnetic simulation software to simulate and analyze the parameters of the antenna to determine the parameters of the antenna, and then use experiments to verify its parameters, calculate the inductance, capacitance and resistance of the antenna, so as to determine the equivalent circuit. After that, design and analyze the antenna circuit, describe the development process of the circuit, and carry out the device preparation work.

[0063] In practical applications, for the wireless power supply and wireless communication antenna based on the LC resonance circuit principle, two flexible substrates 20 with metal coils on their surfaces are fabricated and stacked on top of each other in the Figure 2 and Figure 4 shown manner. At the same time, the straight pins 210 of the two exposed metal coils 21 are connected to two capacitor plates 30 or two conductive composite films 10 with microstructures. When the pressure in the nearby aqueous humor area changes, the sensor device will generate a pressure change through the action of intraocular pressure. This pressure change will cause the pole distance and the plate contact area of the pyramid capacitive pressure sensor to change, and then the capacitance will change, causing the inductance of the coil to change. Eventually, the resonance frequency of the entire circuit will change. By calculating the resonance frequency, the monitored aqueous humor pressure value can be obtained. Alternatively, the number of contact points and the fitting area of the conductive composite film 10 with microstructures increase, causing the resistance value of the pressure-sensitive element to gradually decrease from the maximum value to the minimum value. During the process of the resistance value gradually changing from the maximum value to the minimum value, the dual-line coupled antenna outputs a sine wave, and the sine wave is a sine drive signal for opening the one-way drainage device door.

[0064] The LC resonance circuit needs to design two coils, namely the reading coil and the induction coil. The reading coil is connected to a signal generator, which is also called a signal element or an oscillator. The signal generator is used to generate electrical test signals for specific parameters required by the circuit under test. Its basis and core is the generation of frequency. Different alternating current signals are output to the reading coil. The induction coil is connected in series with a highly sensitive pressure sensor. Based on the principle of electromagnetic coupling, a mutual inductance phenomenon occurs with the reading coil. As the intraocular pressure changes, the loop current in the reading coil will also change accordingly. This change value can be displayed by an oscilloscope, or the signal can be extracted through connection to a single-chip microcomputer and stored in a database. The monitored working data is transmitted to the PC side to achieve the purpose of human-computer interaction.

[0065] The dual-coil coupled antenna needs to be connected to a single-chip microcomputer subsystem to complete the feature extraction of electrical pressure signals. The single-chip microcomputer microprocessor can use the STM32 chip as the core computing unit, and is externally connected with modules such as analog-to-digital conversion, signal amplification, and noise reduction filtering. Since the intraocular pressure transmits an analog signal through the wireless antenna, while the computer processes digital signal quantities, an analog-to-digital conversion chip is required. It usually consists of a sampling circuit and a quantization circuit. The project plans to use the MS5510 analog-to-digital conversion chip of Texas Instruments, which supports 8 bits and 20 MSPS, with a power consumption of only 130 mW and a working temperature of -45°C to 85°C. At the same time, the single-chip microcomputer subsystem has a noise reduction filtering module, which can remove noise, interference, or unnecessary frequency components in the signal to improve the signal quality and reduce signal errors. The signal amplifier can amplify the weak electrical signals extracted by the wireless intraocular pressure sensor to meet various purposes such as signal transmission, processing, and control.

[0066] In actual application, the encapsulated artificial cornea intraocular pressure monitoring device is electromagnetically coupled with the reading coil. At the same time, the reading coil is connected to an oscilloscope, and the reading of the oscilloscope is used to determine the optimal experimental working distance h of the dual coils. At this distance h, the relationship between the force applied to the sensor and the voltage across the reader, as well as the frequency change, are obtained through the measurement of the oscilloscope. Based on the calibration data, the technical parameters are further adjusted, and the pressure signal calibration and measurement standard curve fitting are carried out relying on the calibration platform to verify the signal anti-interference and environmental stability capabilities.

[0067] In a third aspect, the present invention also provides an application method for a glaucoma drainage device capable of monitoring intraocular pressure. The glaucoma drainage device capable of monitoring intraocular pressure is the glaucoma drainage device capable of monitoring intraocular pressure described in the first aspect, or the glaucoma drainage device capable of monitoring intraocular pressure described in the second aspect; the glaucoma drainage device capable of monitoring intraocular pressure integrated with a pressure-sensitive element is implanted into the body once, and at the same time, the functions of reducing intraocular pressure and monitoring intraocular pressure are realized.

[0068] Although the present invention has been described in connection with the various embodiments, however, in the process of implementing the claimed invention, those skilled in the art can understand and achieve other variations of the disclosed embodiments by viewing the drawings, the disclosure, and the like. In the specification, the word "comprising" does not exclude other components or steps, and "a" or "an" does not exclude a plurality. A single processor or other unit may implement several functions recited in the specification. Certain measures are recited in mutually different embodiments, but this does not mean that these measures cannot be combined to produce good results.

[0069] Although the present invention has been described in connection with specific features and their embodiments, it is obvious that various modifications and combinations can be made thereto without departing from the spirit and scope of the present invention. Accordingly, the present specification and the drawings are merely exemplary descriptions of the present invention and are considered to cover any and all modifications, variations, combinations, or equivalents within the scope of the present invention. Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the present invention and its equivalent technologies, the present invention is also intended to include these changes and modifications.

Claims

1. A glaucoma drainage device capable of monitoring intraocular pressure, characterized in that: include: device body, a drainage tube, connected to the inlet of the device body, for draining the aqueous humor to the device body and diffusing it to the tissues around the eye through the device body; A pressure sensitive element, wherein the pressure sensitive element is formed by bonding conductive composite films with microstructures face to face to form a pressure sensitive element with an interlocking structure; A two-wire coupling antenna, comprising two flexible substrates with metal coils on the surface, the flexible substrates are stacked face to face to expose the straight pins of the two metal coils, and one straight pin is connected to a conductive composite film with a microstructure; one of the flexible substrates of the two-wire coupling antenna is bonded to the device body by a biocompatible material, or embedded in the device body; The two-wire coupling antenna also has a wireless communication function, and is connected to the single-chip microcomputer subsystem; the single-chip microcomputer subsystem receives the resistance change of the pressure sensitive element, and converts the resistance change into an electrical pressure signal, further extracts the characteristics of the electrical pressure signal, and then outputs it to the oscilloscope or stores it in a database; When the pressure is less than 24 mmHg, the number of contact points and the bonding area of ​​the conductive composite film with microstructure make the resistance of the pressure sensitive element maximum; When the pressure is greater than or equal to 24 mmHg and the duration is greater than a preset time, the number of contact points and the fitting area of ​​the conductive composite film with a microstructure increase, so that the resistance of the pressure sensitive element gradually decreases from a maximum value to a minimum value. In the process of the resistance gradually changing from a maximum value to a minimum value, the two-wire coupled antenna outputs a sinusoidal wave, which is used to drive an alarm device that communicates with a glaucoma drainage device to sound.

2. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 1, characterized in that: The polymer matrix used in the conductive composite film with microstructure is polydimethylsiloxane, polyimide or polyester; The conductive filler used in the conductive composite film with microstructure includes carbon nanotubes, graphene or metal nanoparticles; The metal coil included in the two-wire coupling antenna is a metal film, a conductive polymer or a carbon-based material.

3. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 1, characterized in that: The two-wire coupling antenna and the pressure sensitive element are packaged in the device body in an embedded packaging manner; The process comprises forming a polyparaxylene protective layer on the surface of the metal coil by a vapor deposition process; Two metal coils were encapsulated using polydimethylsiloxane; Encapsulation of pressure sensitive components using medical biomaterials; After being embedded into the device body, the metal coil with reading function is connected to the microcontroller subsystem for communication.

4. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 1, characterized in that: Two conductive composite films with microstructures are attached to the inner surface or the outer surface of the device body one above and one below.

5. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 1, characterized in that: The cavity of the device body is a trapezoidal valve body cavity to form a Venturi effect; the material of the device body is medical silicone; the device body is gradually narrowed and thin, and the thickness of the front edge is 0.3mm; the device body is symmetrically arranged with two supporting ridges in the direction from the front edge to the drainage tube; the device body is provided with a filtering hole at a position between the front edge and the drainage tube.

6. A glaucoma drainage device capable of monitoring intraocular pressure, characterized in that: include: device body, a drainage tube, connected to the inlet of the device body, for draining the aqueous humor to the device body and diffusing it to the tissues around the eye through the device body; A pressure sensitive element, wherein the pressure sensitive element is a pressure-capacitive liquid environment flexible sensor; A two-wire coupling antenna, comprising two flexible substrates with metal coils on the surface, the flexible substrates are stacked face to face to expose the straight pins of the two metal coils, and one straight pin is connected to a capacitor plate of a pressure-capacitive liquid environment flexible sensor; one of the flexible substrates of the two-wire coupling antenna is bonded to the device body by biocompatible material, or embedded in the device body; The bidirectional coupling antenna also has a wireless communication function, which is connected to the single-chip microcomputer subsystem. The single-chip microcomputer subsystem receives the resistance change of the pressure sensitive element and converts the resistance change into an electrical pressure signal. The electrical pressure signal is further extracted and output to an oscilloscope or stored in a database. The metal coil included in the two-wire coupling antenna is a metal film, a conductive polymer or a carbon-based material. When the pressure is less than 24 mmHg, the number of contact points and the bonding area of ​​the conductive composite film with microstructure make the resistance of the pressure sensitive element maximum; When the pressure is greater than or equal to 24 mmHg and the duration is greater than a preset time, the number of contact points and the fitting area of ​​the conductive composite film with a microstructure increase, so that the resistance of the pressure sensitive element gradually decreases from a maximum value to a minimum value. In the process of the resistance gradually changing from a maximum value to a minimum value, the two-wire coupled antenna outputs a sinusoidal wave, which is used to drive an alarm device that communicates with a glaucoma drainage device to sound.

7. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 6, characterized in that: The dielectric material of the pressure-capacitive liquid environment flexible sensor is polydimethylsiloxane or polypyrrole; the dielectric has a variety of microstructures, and the various microstructures include at least one or more of triangle, cylinder or sphere.

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