Fluid delivery device for eye

Abstract

A fluid delivery device for an eye is provided. The fluid delivery device includes a first component; a second component connected to the first component and forming a fluid-tight chamber with the first component, the chamber being adapted to contain a drug solution to be delivered; the plurality of microneedles are arranged on the first part in a penetrating manner, and the microneedles are arranged to establish a fluid delivery channel which is in fluid communication with the cavity between the first part and the to-be-treated part of the eye when the first part is attached to the eye of the subject; the gas release layer is located in the cavity, and the gas release layer is arranged to release gas into the cavity. The fluid delivery device not only can deliver a drug solution, but also can deliver environment gas expected by treatment, and is simple to operate and convenient to dispose after being used.

Description

Technical Field

[0001] The present invention relates to the field of ophthalmic medical devices, and in particular to a fluid delivery device for the eye. Background Art

[0002] The methods used for ocular treatment usually require the delivery of drug solutions to the cornea, sclera and other areas of the eye in an aerobic or anaerobic environment. However, existing delivery methods or medical delivery devices have many problems in maintaining an oxygen-rich or oxygen-poor environment while delivering drug solutions.

[0003] For example, corneal cross-linking surgery, which uses ultraviolet light and riboflavin solution to induce covalent bonds between collagen fibers in the corneal stroma, usually requires the delivery of riboflavin solution to the eye in an oxygen-rich environment. However, since riboflavin, as a macromolecular drug, is difficult to penetrate and reach the required stroma site, a hockey knife or excimer laser is usually used to remove the corneal epithelium to facilitate the riboflavin solution to reach the treated site, which increases the complexity of the surgery and prolongs the postoperative recovery time; in addition, as the cross-linking surgery proceeds, the oxygen concentration in the cornea will decrease, resulting in inefficient cross-linking photochemical reactions, so it is necessary to replenish oxygen in the stroma in a timely manner. Currently, masks or eye masks are used to supply oxygen from the outside, but this method makes it difficult for oxygen to be quickly absorbed by the cornea, reducing the efficacy of corneal cross-linking surgery.

[0004] Therefore, there is a need for an improved fluid delivery device for the eye. Summary of the invention

[0005] The following is an overview of the subject matter described in detail herein. This overview is not intended to limit the scope of protection of this application.

[0006] In one aspect, the present application provides a fluid delivery device for use in the eye, comprising: first component; a second component connected to the first component and forming a fluid-tight chamber with the first component, the chamber being adapted to contain a drug solution to be delivered; a plurality of microneedles, which penetrate the first component, and the microneedles are configured to establish a fluid delivery channel in fluid communication with the chamber between the first component and a part to be treated in the eye when the first component is attached to the eye of the subject; A gas release layer is located in the chamber, and the gas release layer is configured to release gas into the chamber.

[0007] In the present application, the term "microneedle" may refer to a tiny needle-like object with a length ranging from hundreds of micrometers to several millimeters, which is made of silicon, metal or other materials through microelectronic technology, micro-casting film technology, etc.

[0008] In the present application, the term "subject" may refer to mammals, such as humans, pets, poultry, and the like.

[0009] In the present application, the term "the site to be treated of the eye" may include, but is not limited to, the cornea, sclera and iris of the eye.

[0010] In the present application, the term "fluid" may refer to both a drug solution to be delivered and a gas to be delivered.

[0011] In one embodiment, at least one fluid delivery channel is disposed in the microneedle.

[0012] In one embodiment, the surface of the microneedle has a coating, and the coating is suitable for being dissolved or absorbed by eye tissue after the microneedle is inserted into the site to be treated, so as to expose the fluid delivery channel disposed in the microneedle.

[0013] In one embodiment, the microneedle is configured to dissolve or be absorbed by the eye tissue after being inserted into the area to be treated, so that the channel formed by the microneedle inserted into the area to be treated forms the fluid delivery channel.

[0014] In one embodiment, the material for the gas release layer includes titanium dioxide, calcium peroxide and hydrogel.

[0015] In one embodiment, the gas release layer is formed by water and a titanium dioxide film encapsulated by a waterproof and breathable membrane; and / or, the site to be treated is the cornea.

[0016] In an embodiment, the first component is bendable to fit on the subject's eye; and / or the orthographic projection of the first component on a horizontal plane is circular or elliptical.

[0017] In one embodiment, the material used for the first component and the second component is silicone, hydrogel or polymethylmethacrylate.

[0018] In one embodiment, the gas release layer is disposed in a circumferential region of the first component and at least partially surrounds the plurality of microneedles.

[0019] In another aspect, the present application provides a fluid delivery device for use in the eye, comprising: first component; a second component sealably connected to the first component and forming a chamber with the first component, the chamber being adapted to contain a drug solution to be delivered; a plurality of microneedles, which penetrate the first component, and the microneedles are configured to establish a fluid delivery channel in fluid communication with the chamber between the first component and a part to be treated in the eye when the first component is attached to the eye of the subject; a gas release layer located in the chamber and disposed in a circumferential region of the first component, the gas release layer being configured to release gas into the chamber; a light source located in the chamber and disposed on the second component, the light source being suitable for irradiating light to the gas release layer and the part to be treated; A sensor located in the chamber, the sensor being adapted to measure and transmit environmental parameter data in the chamber; A processing unit is located in the chamber, and the processing unit is suitable for receiving data transmitted by the sensor and controlling the opening and closing of the light source based on the received data to control the pressure in the chamber within the range of 2kPa-10kPa.

[0020] In yet another aspect, the present application provides a fluid delivery device for corneal cross-linking reaction, comprising: first component; a second component connected to the first component and forming a fluid-tight chamber with the first component, the chamber being adapted to contain a riboflavin solution; a plurality of microneedles, which penetrate the first component, and the microneedles are configured to establish a fluid delivery channel between the first component and the cornea that is in fluid communication with the chamber when the first component is attached to the cornea of ​​the subject; The oxygen release layer is located in the chamber, and the oxygen release layer is formed by water and a titanium dioxide film encapsulated by a waterproof and breathable membrane.

[0021] In yet another aspect, the present application provides a fluid delivery device for corneal cross-linking reaction, comprising: first component; a second component connected to the first component and forming a fluid-tight chamber with the first component, the chamber being adapted to contain a riboflavin solution; a plurality of microneedles, which penetrate the first component, and the microneedles are configured to establish a fluid delivery channel between the first component and the cornea that is in fluid communication with the chamber when the first component is attached to the cornea of ​​the subject; an oxygen release layer located in the chamber and arranged in a circumferential region of the first component, the oxygen release layer being formed by water and a titanium dioxide film encapsulated by a waterproof and breathable membrane; a light source located in the chamber and disposed in a circumferential region of the second component, the light source being adapted to irradiate light toward the gas release layer and the part to be treated; a sensor located in the chamber, the sensor being adapted to measure and transmit the pressure in the chamber; A processing unit is located in the chamber, and the processing unit is suitable for receiving the pressure data transmitted by the sensor and controlling the opening and closing of the light source based on the received data to control the pressure in the chamber within the range of 2kPa-10kPa.

[0022] The fluid delivery device of the present application can deliver both drug solutions and gases released by the gas release layer by means of a microneedle structure, and can deliver both drug solutions and gases to the part to be treated, so that they are easily absorbed or adsorbed by the part to be treated, thereby improving the bioavailability of drug solutions and gases. Therefore, the fluid delivery device of the present application is particularly suitable for treatment methods that require drug solutions and gases to maintain an oxygen-rich or oxygen-deficient environment at the same time.

[0023] The fluid delivery device of the present application is provided with a gas release layer, and the gas generated is not only suitable for providing environmental conditions for eye treatment, but also can generate pressure, which helps to promote the delivery of the drug solution to the site to be treated.

[0024] The sensor in the fluid delivery device of the present application can monitor the pressure in the chamber in real time to ensure that the pressure in the chamber is within the appropriate range of 2kPa-10kPa. If the pressure is too high, it is easy to cause lacerations between the corneal layers; if the pressure is too low, it is not conducive to the delivery of gas to the treated area, and it also cannot promote the delivery of the drug solution.

[0025] The fluid delivery device of the present application can be removed at any time after or during treatment, has little biocompatibility concern, and is easy to dispose of.

[0026] The fluid delivery device of the present application is particularly suitable for corneal cross-linking reaction surgery. The gas release layer and the microneedle structure provided in the fluid delivery device of the present application cooperate with each other, so that the oxygen generated by the gas release layer can directly reach the corneal stroma through the microneedle structure and is easily absorbed by the cornea quickly, thereby improving the efficiency of corneal cross-linking, and having a higher oxygen utilization rate compared to the oxygen supply method in the eye mask or mask. The fluid delivery device of the present application improves the efficiency of drug delivery and significantly reduces the difficulty of implementing corneal cross-linking reaction surgery.

[0027] The fluid delivery device of the present application can be manufactured as a disposable device.

[0028] Other features and advantages of the present application will be described in the following description, and partly become apparent from the description, or be understood by implementing the present application. Other advantages of the present application can be realized and obtained by the schemes described in the description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The accompanying drawings are used to provide an understanding of the technical solution of the present application and constitute a part of the specification. Together with the embodiments of the present application, they are used to explain the technical solution of the present application and do not constitute a limitation on the technical solution of the present application.

[0030] Figure 1 It is a schematic structural diagram of a fluid delivery device provided according to an embodiment of the present application; Figure 2 A schematic diagram of the structure of a microneedle in a fluid delivery device provided according to an embodiment of the present application; Figure 3 A schematic structural diagram of a fluid delivery device provided according to another embodiment of the present application; and Figure 4 for Figure 3 A schematic top view of the structure of the fluid delivery device is shown. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solution and advantages of the present application more clear, the embodiments of the present application are described in detail below. It should be noted that the embodiments and features in the embodiments of the present application can be combined with each other arbitrarily without conflict.

[0032] The present application provides a fluid delivery device for the eye, comprising a first component; a second component, which is connected to the first component and forms a fluid-tight chamber with the first component, the chamber being suitable for containing a drug solution to be delivered; a plurality of microneedles, which are penetrated through the first component, the microneedles being configured to establish a fluid delivery channel connected to the chamber fluid between the first component and a part to be treated of the eye when the first component is attached to the subject's eye; and a gas release layer, which is located in the chamber, the gas release layer being configured to release gas into the chamber.

[0033] Figure 1 FIG. 1 is a schematic diagram of the structure of a fluid delivery device provided according to an embodiment of the present application. Figure 1, the fluid delivery device 1 for the eye may include a first component 10, a second component 20, a chamber 30 located between the first component 10 and the second component 20, a plurality of microneedles 40, and a gas release layer 50. The first component 10 may have an outer surface facing the eye of the subject and an inner surface facing away from the eye of the subject, and the first component 10 is bendable to fit on the eye of the subject. The second component 20 may be connected to the first component 10 and form a fluid-tight chamber 30 with the first component 10. The chamber 30 may be suitable for containing a drug solution to be delivered. A plurality of microneedles 40 are provided through the first component 10. When the first component 10 is attached to the eye of the subject, a fluid delivery channel connected to the chamber fluid can be established between the first component 10 and the part to be treated of the patient's eye through the plurality of microneedles 40. The gas release layer 50 may be located in the chamber 30, such as being provided on the first component 10 or the second component 20. The gas release layer 50 may be provided to release gas into the chamber 30.

[0034] Figure 1 The fluid delivery device 1 shown can be suitable for corneal cross-linking surgery to treat the corneal area of ​​the eye. The microneedles 40 can be arranged in the middle area of ​​the first component 10, and the gas release layer 50 can be arranged on the circumferential area of ​​the first component 10, partially or completely surrounding the plurality of microneedles 40. However, in other embodiments, depending on the different parts of the eye to be treated, such as the iris or the sclera, the arrangement positions of the microneedles and the gas release layer can be adaptively changed as needed, and this application will not be repeated here.

[0035] The first component 10 may be bendable to conformably fit onto the subject's eye, and thus may be made of a flexible transparent material that is watertight, airtight but transparent to ultraviolet light, such as silicone or hydrogel, for example, short-term implant grade silicone rubber Med-6015 material.

[0036] In the present application, the first component 10 may also be made of polymethyl methacrylate (PMMA) compatible with microneedles, or an inner lining layer made of polymethyl methacrylate (PMMA) may be added to the area of ​​the first component 10 where the microneedles are arranged to achieve better stability of the microneedle base.

[0037] The second component 20 may also be flexible and made of a flexible transparent material that is water-tight, air-tight but transparent to ultraviolet light, such as silicone or hydrogel, for example, short-term implant grade silicone rubber Med-6015 material.

[0038] use Figure 1When the fluid delivery device is shown, the doctor can use a fixed or mobile light source in the operating room to irradiate the treated area and the gas release layer respectively, and perform the corresponding treatment operation. The light source can generally be divided into two groups, and the two groups of light sources generate ultraviolet light of different wavelengths to pass through the first component and the second component. One group can be used to irradiate the drug solution of the treated area, such as the riboflavin solution used in corneal cross-linking surgery, and the other group can be used to irradiate the gas release layer.

[0039] In the present application, the materials used for the first component and the second component may be the same or different, as long as the sealing connection between the first component 10 and the second component 20 is not adversely affected.

[0040] The connection between the first component 10 and the second component 20 can be achieved by solidification molding, such as by solidification molding through an optical grade contact lens metal mold to connect the two to obtain a fluid-tight chamber 30.

[0041] The orthographic projections of the first component 10 and the second component 20 on the horizontal plane may be circular or elliptical.

[0042] The microneedle 40 can be manufactured using photolithography technology to form a microneedle array mold to ensure that the mold has a fine structure of the microneedle. For example, the selected microneedle material can be injected into the mold, and the microneedle structure can be formed by processes such as hot pressing or solvent evaporation, and then dried and demolded to obtain a microneedle array.

[0043] The microneedle 40 can be in the form of a microneedle with a flow channel inside or a dissolving microneedle. One or more fluid channels provided in the microneedle can be used to deliver drug solutions and gases. If the microneedle adopts a dissolving microneedle or an absorbable microneedle, when the microneedle is inserted into the part to be treated of the subject, the microneedle dissolves in the tissue of the part to be treated or is absorbed by the tissue, thereby leaving multiple fluid channels to deliver drug solutions and gases. In addition, the outer surface of the microneedle with a fluid channel inside can be coated with a dissolving or absorbable coating, and when the microneedle is inserted into the part to be treated of the subject, the coating can dissolve in the tissue of the part to be treated or be absorbed by the tissue, thereby exposing the fluid channel to deliver drug solutions and gases.

[0044] The size, length and distribution of the fluid channels of the microneedle structure can be adjusted to ensure that it has sufficient drug and oxygen transmission capacity. The shape of the fluid channels can also be changed, such as the fluid channels are curved or straight. Figure 2 It is shown that the fluid channel 41 can be a plurality of curved fluid channels.

[0045] The microneedle 40 of the present application may be conical or cylindrical, and the diameter of the cylinder may be set within the range of 30 μm-500 μm, such as 200 μm.

[0046] Before fixing the microneedle array onto the outer surface of the first component (ie, the side facing the wearer's eyes), the outer surface of the first component may be cleaned and treated with absolute ethanol.

[0047] The fluid delivery device of the present application can use a microneedle structure as a drug and oxygen delivery channel. The microneedle structure has many advantages such as low invasiveness, no complicated operation, strong biocompatibility, and can cross the corneal epithelium. A variety of materials can be used to make microneedles, such as silicon, methyl vinyl ether and maleic anhydride (PMVE / MA), polymethyl methacrylate (PMMA), polylactic acid (PLA), and metal materials such as stainless steel, titanium, and nickel. Polymethyl methacrylate (PMMA) is preferred as the material for preparing microneedles.

[0048] When the fluid delivery device of the present application is used in corneal cross-linking surgery, the microneedle structure can be used to deliver drugs for corneal cross-linking, such as riboflavin. This method has many advantages over the common clinical drug drop-by-drop method. For example, in the past, it took about 30 minutes for specialized medical staff to drip drugs before corneal cross-linking surgery, while the delivery device of the present application can save the time of preoperative drug dripping, and the drug can be released by itself with the help of its microneedle structure after the delivery device of the present application is placed in the subject's eye; the corneal epithelial barrier was difficult to cross in the past, and the delivery device of the present application can use its microneedle structure to quickly deliver drugs to the corneal stroma without removing the corneal epithelium, and the drug delivery efficiency is high; at the same time, there is no need to remove the epithelium in a sterile environment, which reduces the difficulty of implementing corneal cross-linking surgery, and is therefore particularly suitable for corneal cross-linking surgery in grassroots or remote hospitals, so that a wider range of patients can benefit.

[0049] The gas release layer 50 of the present application can be a mixed material of titanium dioxide TiO2 film and water encapsulated by a waterproof and breathable film. The material of the waterproof and breathable film can be a polytetrafluoroethylene microporous membrane, which only transmits oxygen and free radicals but not pre-stored pure water. The thickness of the titanium dioxide film can be in the range of 200 μm-400 μm, such as 350 μm.

[0050] Since the gas release layer of the present application adopts TiO2 thin film, non-adiabatic lattice movement will occur on the TiO2 surface, including two stages of expansion and recovery. This lattice movement can promote water dissociation to produce oxygen, and the produced oxygen can be transmitted to the corneal stroma through the microneedle structure.

[0051] Since the gas release layer of the present application adopts TiO2 film, it can be stored for a long time at room temperature away from light; its ultraviolet light absorption characteristics can be used to protect the corneal epithelial stem cells at the corneal edge to prevent stem cell damage caused by the patient's rotation of the eyeball during surgery; its antibacterial activity can be used for hypoxic corneal bacterial infection diseases.

[0052] In addition, the gas release layer provided in the present application, such as the TiO2 film, can also protect the area that does not require corneal cross-linking surgery from unexpected reactions because it covers part of the corneal area.

[0053] The gas release layer 50, such as a TiO2 film, can be deposited on the inner surface of the first component by pulse magnetron sputtering. The specific steps may include cleaning the inner surface of the first component with anhydrous ethanol, using ultrasonic cleaning of the glass surface to be plated, the solution is a 5% neutral detergent, rinsing the glass surface with deionized water, and drying. The TiO2 film is deposited by a coating machine. A pure Ti cylindrical target and a DC pulse power supply are used, and the coating conditions are a vacuum of 2×10 -3 Pa, and the deposition power is 5-20 kW.

[0054] In addition to TiO2, the gas release layer 50 can also be prepared using a variety of materials. For example, hydrogel can be used as a carrier of oxygen dissolved in water (such as microalgae, perfluorocarbon, hemoglobin, etc.); the ability of calcium peroxide to generate oxygen when in contact with water can be used to prepare materials such as calcium peroxide nanoparticles or hydrogel.

[0055] In addition, the gas release layer 50 can also generate gas in other ways, such as generating gas under or without ultraviolet light excitation, or generating gas under different light bands; it can also generate gas under the action of electric field or magnetic field.

[0056] The encapsulation of the components of the fluid delivery device 1 of the present application can be carried out in a variety of ways. For example, it can include: injecting a silicone rubber solution and a curing agent into a mold, vacuum degassing treatment, curing and heating to form a first component and a second component; after curing, using a CO2 laser cutting machine or drilling equipment to drill regularly arranged array holes at the first component, and then attaching the microneedle structure to the holes for encapsulation; shaping the gas release layer material such as titanium dioxide TiO2 into a ring shape, and attaching it to the inner surface of the first component or the second component; finally completing the sealing connection between the first component and the second component to form a chamber, and injecting a drug solution such as a riboflavin solution into the chamber.

[0057] The prepared fluid delivery device filled with the drug solution can be immersed in the drug solution and stored away from light (eg, in a brown bottle).

[0058] The fluid delivery device of the present application can be manufactured for single use.

[0059] The present application also provides a fluid delivery device for the eye, comprising a first component; a second component, which can be sealably connected to the first component and forms a chamber with the first component, the chamber being suitable for containing a drug solution to be delivered; a plurality of microneedles, which are inserted through the first component, the microneedles being configured to establish a fluid delivery channel connected to the chamber fluid between the first component and the part to be treated of the eye when the first component is attached to the subject's eye; a gas release layer, which is located in the chamber and arranged in a circumferential area of ​​the first component, the gas release layer being configured to release gas into the chamber; a light source, which is located in the chamber and arranged on the second component, the light source being suitable for irradiating light to the gas release layer and the part to be treated; a sensor, which is located in the chamber, the sensor being suitable for measuring and sending environmental parameter data in the chamber; a processing unit, which is located in the chamber, the processing unit being suitable for receiving data sent by the sensor and controlling the opening and closing of the light source based on the received data, so as to control the pressure in the chamber within the range of 2kPa-10kPa.

[0060] Figure 3 FIG. 1 is a schematic diagram of the structure of a fluid delivery device provided according to another embodiment of the present application. Figure 3 , the fluid delivery device 1' for the eye of the present application may include a first component 100, a second component 200, a chamber 300 located between the first component 100 and the second component 200, a plurality of microneedles 400, a gas release layer 500, a light source 600, a sensor 700, and a processing unit 800. The first component 100 may have an outer surface facing the eye of the subject and an inner surface facing away from the eye of the subject, and the first component 100 is bendable to fit on the eye of the subject. The second component 200 may be connected to the first component 100 and form a fluid-tight chamber 300 with the first component 100. The chamber 300 may be suitable for containing a drug solution to be delivered. A plurality of microneedles 400 are provided through the first component 100. When the first component 100 is attached to the eye of the subject, a fluid delivery channel connected to the chamber fluid can be established between the first component 100 and the part to be treated of the patient's eye through the plurality of microneedles 400. The gas release layer 500 may be located in the chamber 300, such as being provided on the first component 100. The gas release layer 500 may be configured to release gas into the chamber 300. The light source 600 may be located in the chamber 300 and disposed on the second component 200, and may be disposed opposite to the gas release layer 500. The light source 600 is suitable for irradiating light to the gas release layer 500 and the part to be treated, such as the cornea, to perform a corneal cross-linking reaction. The sensor 700 may be located in the chamber 300. The sensor 700 may be suitable for measuring and sending environmental parameter data in the chamber 300. The processing unit 800 may be located in the chamber 300. The processing unit 800 may be suitable for receiving data sent by the sensor 700 and controlling the opening and closing of the light source 600 based on the received data.

[0061] Figure 4 It is shown that the orthographic projection of the second component 200 on the horizontal plane may be a circle. However, in other embodiments, the orthographic projection of the second component 200 on the horizontal plane may also be an ellipse or other shapes.

[0062] The light source 600 may be disposed in the encapsulated waterproof breathable membrane and the waterproof breathable membrane may be disposed on the second component 200 by adhesion or the like. In the present application, the light source 600 may be a plurality of LED lamps, such as an LED micro light strip. If the gas release layer is located in the circumferential region of the first component in an annular shape, the LED micro light strip may also be located in the circumferential region of the second component in an annular shape and disposed corresponding to the gas release layer. Figure 4 A ring-shaped light source 600 is shown located in a circumferential area of ​​the second component.

[0063] The light source 600 can irradiate light to the drug solution at the part to be treated or to the gas release layer. For example, the light source 600 can be divided into two groups of LED lights, one group of LED lights is used to irradiate the part to be treated, such as irradiating the riboflavin solution at the cornea at the part to be treated with ultraviolet light in the range of 360-370nm to perform corneal cross-linking reaction; the other group of LED lights is used to irradiate the gas release layer with ultraviolet light in the range of 360nm-380nm to make the gas release layer release oxygen.

[0064] The sensor 700 may be disposed in the encapsulated waterproof and breathable membrane to monitor in real time the pressure and concentration of the gas (such as oxygen) in the chamber 300 connected to the microneedle. The sensor 700 may be any of capacitive, resistive or ionization types.

[0065] The control unit 800 may be disposed in the encapsulated waterproof breathable membrane. The control unit 800 may be connected to the sensor 700 and the light source 600 respectively by wire or wireless means. For example, the control unit 800 may receive data of real-time oxygen pressure in the chamber from the sensor, and dynamically control and adjust the light source according to changes in the pressure data. The control method includes, but is not limited to, turning on or off a group of LED lights used to illuminate the gas release layer to extend or shorten the light irradiation time, to accelerate or slow down the release of gas, etc.

[0066] In the present application, the control unit 800 may use a microcontroller unit (MCU), a field programmable gate array (FPGA), etc. to implement the above functions.

[0067] The present application also provides a method for delivering a drug solution and oxygen to the eye using the above-mentioned fluid delivery device. The method may include attaching the fluid delivery device to the subject's eye; piercing the subject's to-be-treated site, such as the cornea, with a plurality of microneedles, so that the drug solution contained in the chamber is delivered to the to-be-treated site with the aid of the microneedles; applying ultraviolet light in the range of 360-370nm to the drug solution; applying ultraviolet light in the range of 360nm-380nm to the gas release layer to release oxygen, so that the oxygen is delivered to the to-be-treated site with the aid of the microneedles.

[0068] When the fluid delivery device in the present application is used in corneal cross-linking surgery, the use process may include a user such as a doctor taking out the fluid delivery device that is stored in a dark brown or opaque medicine box and immersed in a riboflavin solution away from light, and the fluid-filled device is already filled with riboflavin solution; after taking it out, gently placing the device in the center of the patient's cornea and confirming that it is well positioned; instructing the patient to directly and slowly close his eyes or use a contact lens suction stick to lightly press the middle of the device and then close his eyes, at which time the microneedle structure breaks through the corneal epithelial barrier and reaches the corneal stroma; after closing the eyes, the fluid delivery device is squeezed by the force of the eyelids, and the chamber pressure increases, causing the riboflavin solution to flow out through the fluid delivery channel of the microneedle for 10-30 minutes. After the corneal stroma is basically infiltrated with riboflavin, the patient is asked to open his eyes and irradiate with 360-370nm ultraviolet light to perform corneal cross-linking surgery; at the same time, the gas release layer is irradiated with 360-380nm LED light to make TiO2 produce photocatalytic effect to release oxygen to provide the oxygen required for corneal cross-linking reaction and use the generated gas to further promote the residual riboflavin to infiltrate the cornea, and then produce oxygen to supplement the oxygen consumed in the cross-linking reaction; at the same time, the sensor is used to sense the pressure change in the chamber in real time and cooperate with the control unit to dynamically adjust the opening and closing of a group of LED lights used to irradiate the gas release layer to extend or shorten the irradiation time accordingly, which avoids excessive gas pressure from causing damage to the patient's cornea or avoids excessively low gas pressure from being unfavorable for the delivery of drug solution. After the treatment is completed, the fluid delivery device is removed, and the patient's eyes are instilled with conventional antibiotic eye ointment and covered with a bandage lens.

[0069] Although the embodiments of the present application have been shown and described above, it can be understood that the above embodiments are exemplary and cannot be understood as limitations on the present application. Those skilled in the art can change, modify, replace and modify the above embodiments within the scope of the present application.

Claims

1. A fluid delivery device for an eye, characterized in that: include: first component; a second component connected to the first component and forming a fluid-tight chamber with the first component, the chamber being adapted to contain a drug solution to be delivered; a plurality of microneedles, which penetrate the first component, and the microneedles are configured to establish a fluid delivery channel in fluid communication with the chamber between the first component and a part to be treated in the eye when the first component is attached to the eye of the subject; A gas release layer is located in the chamber, and the gas release layer is configured to release gas into the chamber.

2. The fluid delivery device according to claim 1, characterized in that At least one fluid delivery channel is disposed in the microneedle.

3. The fluid delivery device according to claim 2, characterized in that The surface of the microneedle has a coating, and the coating is suitable for being dissolved or absorbed by eye tissue after the microneedle is inserted into the site to be treated, so as to expose the fluid delivery channel arranged in the microneedle.

4. The fluid delivery device according to claim 1, characterized in that The microneedle is configured to dissolve or be absorbed by eye tissue after being inserted into the part to be treated, so that the channel formed by the microneedle inserted into the part to be treated forms the fluid delivery channel.

5. The fluid delivery device according to claim 1, characterized in that Materials for the gas release layer include titanium dioxide, calcium peroxide, and hydrogel.

6. The fluid delivery device according to claim 5, characterized in that The gas release layer is formed by water and a titanium dioxide film encapsulated by a waterproof and breathable membrane; and / or, The part to be treated is the cornea.

7. The fluid delivery device according to claim 1, characterized in that The first component is bendable to fit over the subject's eye; and / or, The orthographic projection of the first component on a horizontal plane is a circle or an ellipse.

8. The fluid delivery device according to claim 7, characterized in that The material used for the first member and the second member is silicone, hydrogel or polymethylmethacrylate.

9. The fluid delivery device according to claim 7, characterized in that The gas release layer is disposed in a circumferential region of the first component and at least partially surrounds the plurality of microneedles.

10. A fluid delivery device for use in the eye, characterized in that: include: first component; a second component sealably connected to the first component and forming a chamber with the first component, the chamber being adapted to contain a drug solution to be delivered; a plurality of microneedles, which penetrate the first component, and the microneedles are configured to establish a fluid delivery channel in fluid communication with the chamber between the first component and a part to be treated in the eye when the first component is attached to the eye of the subject; a gas release layer located in the chamber and disposed in a circumferential region of the first component, the gas release layer being configured to release gas into the chamber; a light source located in the chamber and disposed on the second component, the light source being suitable for irradiating light to the gas release layer and the part to be treated; A sensor located in the chamber, the sensor being adapted to measure and transmit environmental parameter data in the chamber; A processing unit is located in the chamber, and the processing unit is suitable for receiving data transmitted by the sensor and controlling the opening and closing of the light source based on the received data to control the pressure in the chamber within the range of 2kPa-10kPa.

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