Glaucoma drainage device capable of monitoring intraocular pressure and application method thereof

Abstract

The invention discloses a glaucoma drainage device capable of monitoring intraocular pressure and an application method of the glaucoma drainage device, and belongs to the technical field of intraocular pressure monitoring and drainage. Comprising a device body, a drainage tube, a pressure sensitive element and a double-line coupled antenna. The drainage tube is communicated with the inlet of the device body and is used for leading aqueous humor to the device body and diffusing the aqueous humor to tissues around eyes through the device body. The pressure sensitive element with an interlocking structure is constructed by attaching conductive composite films with microstructures face to face. The double-line coupled antenna comprises two flexible substrates with metal coils on the surfaces, and linear pins of the two metal coils are exposed after the flexible substrates are stacked up and down in a face-to-face manner. And one linear pin is connected with one conductive composite film with a microstructure. And one flexible substrate of the double-line coupled antenna is adhered to the device body or embedded into the device body by using a biocompatible material. The pressure sensitive element can also be bonded on the device body or embedded into the device body.

Description

Technical Field

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

[0002] When the patient's high intraocular pressure is difficult to control with medication, it is necessary to implant a glaucoma drainage device to divert the aqueous humor in the eye, thereby reducing intraocular pressure. Although the existing glaucoma drainage device can effectively drain the aqueous humor, it cannot monitor the intraocular pressure in real time, that is, "only drainage without monitoring". In this way, it will be inconvenient to grasp the patient's intraocular pressure data in a timely manner, and the timeliness of intraocular pressure monitoring is particularly important for doctors to analyze medical records and determine treatment plans. When the patient's elevated intraocular pressure is not monitored and controlled in time, it is easy to miss the best treatment time, causing delays in the disease, aggravating irreversible glaucomatous optic nerve damage, and leading to a relatively high blindness, which will affect the treatment effect, which will greatly increase the social and economic burden.

[0003] Although there have been experimental studies on intraocular pressure monitoring devices implanted in the eye, they can only monitor intraocular pressure and do not have the function of draining aqueous humor, that is, "monitoring only but not drainage". In addition, the technology is immature, the risk is high and there is no clinical application.

[0004] Given that timely, accurate, and long-term monitoring and control of intraocular pressure are urgent needs for glaucoma treatment and are closely related to the patient's prognosis, and currently there is no device that has the functions of both drainage and real-time monitoring of intraocular pressure. Therefore, it is urgent to propose a glaucoma drainage device that can monitor intraocular pressure, and at the same time has the functions of real-time, accurate, and long-term monitoring of intraocular pressure, as well as drainage of aqueous humor and lowering of intraocular pressure, that is, "both monitoring and drainage". 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, and an application method thereof.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

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

[0008] device body,

[0009] 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;

[0010] 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;

[0011] A two-wire coupling antenna comprises two flexible substrates with metal coils on their surfaces, wherein the flexible substrates are stacked face to face and two straight pins of the metal coils are exposed, 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 using a biocompatible material, or is embedded in the device body.

[0012] As a possible implementation, when the pressure is less than 24 mmHg, the number of contact points and the bonding area of ​​the conductive composite film with a microstructure make the resistance of the pressure sensitive element maximum;

[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 a microstructure increase, so that the resistance of the pressure sensitive element gradually decreases from the maximum value to the minimum value. In the process of the resistance gradually changing from the maximum value to the minimum value, the two-wire coupled antenna outputs a sine wave, which is used to drive an alarm device that communicates with the glaucoma drainage device to sound.

[0014] As a possible implementation method, the two-wire coupled antenna also has a wireless communication function, which is communicatively 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 features of the electrical pressure signal, and outputs it to an oscilloscope or stores it in a database.

[0015] As a possible implementation method, the polymer matrix used in the conductive composite film with microstructure is polydimethylsiloxane or polyimide or polyester;

[0016] The conductive filler used in the conductive composite film with microstructure includes carbon nanotubes, graphene or metal nanoparticles;

[0017] The metal coil included in the two-wire coupling antenna is a metal film, a conductive polymer or a carbon-based material.

[0018] As a possible implementation method, a two-wire coupled antenna and a pressure sensitive element are packaged in the device body in an embedded packaging manner; specifically, a polyparaxylene protective layer is formed on the surface of the metal coil by a vapor deposition process; two metal coils are packaged using polydimethylsiloxane; the pressure sensitive element is packaged using medical biomaterials; and 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 manner, two conductive composite films with microstructures are attached one above the other to the inner surface or the outer surface of the device body.

[0020] As a possible implementation method, 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 front edge thickness is 0.3 mm; 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.

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

[0022] device body,

[0023] 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;

[0024] A pressure sensitive element, wherein the pressure sensitive element is a pressure-capacitive liquid environment flexible sensor;

[0025] A two-wire coupling antenna comprises two flexible substrates with metal coils on their surfaces, wherein the flexible substrates are stacked face to face and the straight pins of the two metal coils are exposed, 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 using biocompatible material, or embedded into the device body.

[0026] As a possible implementation, the dielectric material included in 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.

[0027] In a third aspect, the present invention further provides an application method of a glaucoma drainage device capable of monitoring intraocular pressure, wherein 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 in the body at one time, and simultaneously achieves the effects of lowering intraocular pressure and monitoring intraocular pressure.

[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 a whole. Through a single implantation operation, i.e., without increasing the number of operations, surgical damage, or pain of the patient, it can not only realize the real-time continuous monitoring of intraocular 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 conditions, and benefits patients.

[0030] 2. By using the glaucoma drainage device capable of monitoring intraocular pressure provided by the present invention, 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 medical institutions, providing doctors with objective and accurate intraocular pressure data, thus 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 use of microstructure design and conductive composite thin 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 allows the sensor to produce obvious resistance changes in response to slight pressure changes, thereby improving the sensitivity of the sensor. Conductive composite thin 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.

[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 pressure-capacitive liquid environment flexible sensor, which has the advantages of high sensitivity, flexibility, good biocompatibility, easy integration and miniaturization, real-time monitoring and feedback, durability and stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 A schematic diagram of the structure of a pressure sensitive element provided by an embodiment of the present invention;

[0034] Figure 2 A schematic diagram of the structure of a dual-wire coupling antenna provided in an embodiment of the present invention;

[0035] Figure 3 A schematic diagram of the structure of a pressure-capacitive liquid environment flexible sensor provided in an embodiment of the present invention;

[0036] Figure 4 A schematic structural diagram of another dual-wire coupling antenna provided in an embodiment of the present invention.

[0037] Reference numerals:

[0038] 10-conductive composite film;

[0039] 20-flexible substrate, 21-metal coil, 210-straight pin;

[0040] 30-capacitor plate, 31-dielectric. DETAILED DESCRIPTION

[0041] In order to clearly describe the technical solutions of the embodiments of the present invention, in the embodiments of the present invention, words such as "first" and "second" are used to distinguish the same items 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 their order is not limited. Those skilled in the art can understand that words such as "first" and "second" do not limit the quantity and execution order, and words such as "first" and "second" do not necessarily limit them to be different.

[0042] It should be noted that, in the present invention, words such as "exemplary" or "for example" are used to indicate examples, illustrations or descriptions. Any embodiment or design described as "exemplary" or "for example" in the present invention should not be interpreted as being more preferred or more advantageous than other embodiments or designs. Specifically, the use of words such as "exemplary" or "for example" is intended to present related concepts in a specific way.

[0043] In the present invention, "at least one" means one or more, and "plurality" means two or more. "And / or" describes the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B can mean: A exists alone, A and B exist at the same time, 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 of the following" or similar expressions refers to any combination of these items, including any combination of single or plural items. For example, at least one of a, b or c can mean: 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, c can be single or multiple.

[0044] See also Figure 1 and Figure 2 The embodiment of the present invention provides a glaucoma drainage device capable of monitoring intraocular pressure, comprising: a device body (not shown in the figure), a drainage tube, a pressure sensitive element and a two-wire coupling antenna. The drainage tube is connected to the inlet of the device body, and is used to drain the aqueous humor to the device body, and diffuse it to the tissues around the eye through the device body. The pressure sensitive element is formed by face-to-face bonding of a conductive composite film 10 with a microstructure to form a pressure sensitive element with an interlocking structure. The two-wire coupling antenna comprises two flexible substrates 20 with metal coils 21 on the surface, and the flexible substrates 20 are stacked face to face up and down to expose two straight pins 210 of the metal coils 21. A straight pin 210 is connected to a conductive composite film 10 with a microstructure. One of the flexible substrates 20 of the two-wire coupling antenna is bonded to the device body using a biocompatible material, or embedded in the inside of the device body. The pressure sensitive element can also be bonded to the device body, or embedded in the inside of 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. Use polydimethylsiloxane (PDMS) to encapsulate the two metal coils.

[0052] S12. Use medical biomaterials to encapsulate pressure sensitive components.

[0053] S13. A pressure sensitive element is connected to a straight pin included in a two-wire coupling antenna and then embedded into the device body, connecting the metal coil with a reading function to the single-chip microcomputer subsystem for communication.

[0054] When the pressure is less than 24 mmHg, the number of contact points and the fitting area of ​​the conductive composite film with a 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 the preset time (1 hour), 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 the maximum value to the minimum value. In the process of the resistance gradually changing from the maximum value to the minimum value, the two-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] Second, see Figure 3 and Figure 4 The embodiment of the present invention also provides another glaucoma drainage device capable of monitoring intraocular pressure, comprising: a device body, a drainage tube, which is connected to the inlet of the device body and is used to draw aqueous humor out to the device body and diffuse it to the tissues around the eye through the device body; a pressure sensitive element, which is a pressure-capacitive liquid environment flexible sensor; a two-wire coupling antenna, which comprises two flexible substrates with metal coils on the surface, the flexible substrates are stacked face to face up and down to expose two straight pins of the 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 using a biocompatible material, or is embedded in the inside of the device body.

[0056] Pressure-capacitive liquid environment flexible sensors have the advantages of high sensitivity, flexibility, good biocompatibility, easy integration and miniaturization, real-time monitoring and feedback, durability and stability.

[0057] The pressure-capacitive liquid environment flexible sensor is formed by a capacitor plate 30 and a dielectric 31, wherein 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 the spacing of the capacitor plates 30 or the contact area of ​​the capacitor plates 30 to change. The change in the spacing or contact area of ​​the capacitor plates 30 will cause the change in the capacitance value. It can be obtained by the formula:

[0058]

[0059] Wherein, C may represent the capacitance value, d may represent the distance between the two capacitor plates 30, S may represent the facing area or contact area of ​​the two capacitor plates 30, and ε 0 , ε r It can represent the dielectric constant of the dielectric 31 between the two capacitor plates 30.

[0060] The dielectric 31 is made of polydimethylsiloxane or polypyrrole, thereby avoiding adverse reactions such as rejection and infection. The dielectric 31 has a variety of microstructures, and the multiple microstructures include at least one or more of a triangle, a cylinder or a sphere. Preferably, the microstructure of the dielectric 31 is pyramid-shaped, thereby improving the sensitivity of the capacitive pressure sensing module.

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

[0062] The framework of the entire induction system is based on the LC circuit. During the design, the HFSS electromagnetic simulation software is first used to simulate and analyze the antenna parameters to determine the antenna parameters, and then the parameters are verified by experiments, and the antenna inductance, capacitance and resistance are calculated to determine the equivalent circuit. After that, the antenna circuit is designed and analyzed, the circuit development process is described, and device preparation work is carried out.

[0063] In practical applications, the wireless power supply and wireless communication antenna based on the LC resonant circuit principle is a flexible substrate 20 with metal coils on both surfaces. Figure 2 and Figure 4 The method shown is superimposed up and down, and 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 pressure of the sensor device will change through the intraocular pressure. This pressure change will cause the pole distance and the contact area of ​​the plate of the pyramid capacitive pressure sensor to change, and then the change in capacitance will cause the inductance of the coil to change, and finally cause the resonant frequency of the entire circuit to change. By calculating the resonant 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 a microstructure are increased, so that the resistance of the pressure sensitive element gradually decreases from the maximum value to the minimum value. In the process of the resistance gradually changing from the maximum value to the minimum value, the two-wire coupling antenna outputs a sine wave, and the sine wave is a sine drive signal for opening the door of the one-way drainage device.

[0064] The LC resonant circuit requires the design of 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 oscillator. The signal generator is used to generate electrical test signals of specific parameters required by the circuit under test. Its basis and core is the generation of frequency, and different AC signals are output to the reading coil. The induction coil is connected in series with a high-sensitivity pressure sensor, which produces mutual inductance with the reading coil based on the principle of electromagnetic coupling. 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 it can be connected to a single-chip microcomputer to extract the signal and store it in a database. The monitored working data can be transmitted to the PC 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 the electrical pressure signal. The single-chip microprocessor can use the STM32 chip as the core computing unit, and external analog-to-digital conversion, signal amplification, noise reduction filtering and other modules. Since the intraocular pressure is transmitted through the wireless antenna as an analog signal, and the computer processes the digital signal, a digital-to-analog conversion chip is required, which is usually composed of a sampling circuit and a quantization circuit. The project plans to use the Texas Instruments MS5510 analog-to-digital conversion chip, which supports 8-bit 20MSPS, consumes only 130mW, and operates at a temperature of -45℃ to 85℃. At the same time, the single-chip microcomputer subsystem has a noise reduction filtering module that can remove noise, interference or unnecessary frequency components in the signal to achieve the purpose of improving signal quality and reducing signal errors. The signal amplifier can amplify the weak electrical signal extracted by the wireless intraocular pressure sensor to meet multiple purposes such as signal transmission, processing and control.

[0066] In actual application, the packaged artificial cornea intraocular pressure monitoring device is electromagnetically coupled to the reading coil, and the reading coil is connected to the 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 at both ends of the reader, as well as the frequency change, is 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 based on the calibration platform to verify the signal anti-interference and environmental stability capabilities.

[0067] In a third aspect, the present invention further provides an application method of a glaucoma drainage device capable of monitoring intraocular pressure, wherein 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 in the body at one time, and simultaneously achieves the effects of lowering intraocular pressure and monitoring intraocular pressure.

[0068] Although the present invention is described herein in conjunction with various embodiments, in the process of implementing the claimed invention, those skilled in the art may understand and implement other variations of the disclosed embodiments by viewing the drawings, the disclosure, and the drawings, etc. In the specification, the word "comprising" does not exclude other components or steps, and "one" or "an" does not exclude multiple situations. A single processor or other unit can implement several functions listed in the specification. Certain measures are recorded in 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 conjunction with specific features and embodiments thereof, it is apparent that various modifications and combinations may be made thereto without departing from the spirit and scope of the present invention. Accordingly, this specification and the accompanying drawings are merely exemplary illustrations of the present invention and are deemed to cover any and all modifications, variations, combinations or equivalents within the scope of the present invention. Obviously, those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to include such modifications and variations if they fall within the scope of the present invention and its equivalents.

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 comprises two flexible substrates with metal coils on their surfaces, wherein the flexible substrates are stacked face to face and two straight pins of the metal coils are exposed, 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 using a biocompatible material, or is embedded in the device body.

2. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 1, characterized in that: 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.

3. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 1, characterized in that: The two-wire 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 change of the pressure sensitive element, and converts the resistance change into an electrical pressure signal, further extracts the features of the electrical pressure signal, and then outputs it to an oscilloscope or stores it in a database.

4. 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.

5. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 3, 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; Use medical biomaterials to encapsulate pressure sensitive components; After being embedded into the device body, the metal coil with reading function is connected to the microcontroller subsystem for communication.

6. 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.

7. 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.

8. 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 comprises two flexible substrates with metal coils on their surfaces, wherein the flexible substrates are stacked face to face and the straight pins of the two metal coils are exposed, 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 using biocompatible material, or embedded into the device body.

9. The glaucoma drainage device capable of monitoring intraocular pressure according to claim 8, 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.

10. A method for using a glaucoma drainage device capable of monitoring intraocular pressure, characterized in that: The glaucoma drainage device capable of monitoring intraocular pressure is the glaucoma drainage device capable of monitoring intraocular pressure as described in any one of claims 1 to 7, or the glaucoma drainage device capable of monitoring intraocular pressure as described in any one of claims 8 or 9; the glaucoma drainage device capable of monitoring intraocular pressure integrated with a pressure sensitive element is implanted in the body at one time, and simultaneously achieves the effects of lowering intraocular pressure and monitoring intraocular pressure.

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