Fluid delivery devices for use in the eye

Abstract

The present application provides a fluid delivery device for use in the eye. 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 suitable for containing a drug solution to be delivered; a plurality of microneedles inserted through the first component, the microneedles being configured to establish a fluid delivery channel between the first component and the area to be treated in the eye, which is fluidically connected to the chamber, when the first component is attached to the subject's eye; and a gas-releasing layer located within the chamber, the gas-releasing layer being configured to release gas into the chamber. The fluid delivery device of the present application can deliver both drug solutions and the desired ambient gas for therapeutic treatment, is simple to operate, and is convenient for post-use disposal.

Description

Technical Field

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

[0002] Ocular treatments typically require delivering 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 numerous challenges in maintaining an oxygen-rich or oxygen-depleted 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, typically requires delivering the riboflavin solution to the eye in an oxygen-rich environment. However, because riboflavin, as a large molecule, is difficult to penetrate and reach the required stroma, a hockey knife or excimer laser is typically used to remove the corneal epithelium to facilitate the riboflavin solution reaching the treatment area, increasing the complexity of the surgery and prolonging the postoperative recovery time. In addition, as the cross-linking procedure progresses, the oxygen concentration in the cornea decreases, resulting in inefficient cross-linking photochemical reactions. Therefore, it is necessary to replenish oxygen in the stroma in a timely manner. Currently, oxygen is supplied externally through masks or eye masks, 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 an eye, comprising:

[0007] first component;

[0008] 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;

[0009] a plurality of microneedles passing through the first component, wherein the microneedles are configured to establish a fluid delivery channel between the first component and a to-be-treated area of ​​the eye in fluid communication with the chamber when the first component is attached to the subject's eye;

[0010] A gas release layer is located in the chamber and is configured to release gas into the chamber.

[0011] In this 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 microelectronics technology, micro-casting technology, etc.

[0012] In the present application, the term "subject" may refer to mammals, such as humans, pets, poultry, and the like.

[0013] 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.

[0014] In the present application, the term "fluid" may refer to both a drug solution to be delivered and a gas to be delivered.

[0015] In one embodiment, at least one fluid delivery channel is provided in the microneedle.

[0016] In one embodiment, the surface of the microneedle has a coating, and the coating is suitable for dissolving or being absorbed by the eye tissue after the microneedle is inserted into the area to be treated, so as to expose the fluid delivery channel provided in the microneedle.

[0017] 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.

[0018] In one embodiment, the material for the gas-releasing layer includes titanium dioxide, calcium peroxide, and hydrogel.

[0019] In one embodiment, the gas-releasing 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.

[0020] In one embodiment, the first component is bendable to fit on the subject's eye; and / or an orthographic projection of the first component on a horizontal plane is circular or elliptical.

[0021] In one embodiment, the material used for the first component and the second component is silicone, hydrogel or polymethyl methacrylate.

[0022] In one embodiment, the gas-releasing layer is disposed in a circumferential region of the first component and at least partially surrounds the plurality of microneedles.

[0023] In another aspect, the present application provides a fluid delivery device for use in an eye, comprising:

[0024] first component;

[0025] 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;

[0026] a plurality of microneedles passing through the first component, wherein the microneedles are configured to establish a fluid delivery channel between the first component and a to-be-treated area of ​​the eye in fluid communication with the chamber when the first component is attached to the subject's eye;

[0027] a gas release layer located in the cavity and disposed in a circumferential region of the first component, the gas release layer being configured to release gas into the cavity;

[0028] a light source located in the chamber and disposed on the second component, the light source being adapted to irradiate light toward the gas-releasing layer and the area to be treated;

[0029] a sensor located in the chamber, the sensor being adapted to measure and transmit environmental parameter data in the chamber;

[0030] 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.

[0031] In yet another aspect, the present application provides a fluid delivery device for corneal cross-linking reaction, comprising:

[0032] first component;

[0033] 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;

[0034] a plurality of microneedles passing through the first component, wherein the microneedles are configured to establish a fluid delivery channel between the first component and the cornea in fluid communication with the chamber when the first component is attached to the cornea of ​​the subject;

[0035] The oxygen releasing layer is located in the chamber and is formed by water and a titanium dioxide film encapsulated by a waterproof and breathable membrane.

[0036] In yet another aspect, the present application provides a fluid delivery device for corneal cross-linking reaction, comprising:

[0037] first component;

[0038] 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;

[0039] a plurality of microneedles passing through the first component, wherein the microneedles are configured to establish a fluid delivery channel between the first component and the cornea in fluid communication with the chamber when the first component is attached to the cornea of ​​the subject;

[0040] an oxygen-releasing layer located in the chamber and disposed in a circumferential region of the first component, the oxygen-releasing layer being formed of water and a titanium dioxide thin film encapsulated by a waterproof and breathable membrane;

[0041] 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-releasing layer and the area to be treated;

[0042] a sensor located in the chamber, the sensor being adapted to measure and transmit the pressure in the chamber;

[0043] A processing unit is located in the chamber, and the processing unit is suitable for receiving 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.

[0044] The fluid delivery device of the present application can deliver both drug solutions and gases released by the gas-releasing layer by means of a microneedle structure, and can deliver both drug solutions and gases to the area to be treated. The drug solutions and gases are easily absorbed or adsorbed by the area to be treated, thereby improving the bioavailability of the drug solutions and gases. Therefore, the device is particularly suitable for treatment methods that require drug solutions and gases to maintain an oxygen-rich or oxygen-deficient environment.

[0045] The fluid delivery device of the present application is provided with a gas release layer. The gas generated is not only suitable for providing environmental conditions for eye treatment, but also can generate pressure, which helps to push the drug solution to the area to be treated.

[0046] The sensor in the fluid delivery device of this application monitors the pressure within the chamber in real time, ensuring that it remains within the appropriate range of 2kPa-10kPa. Excessive pressure can easily cause lacerations between corneal layers; while too low a pressure hinders gas delivery to the treatment area and fails to facilitate drug solution delivery.

[0047] 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.

[0048] The fluid delivery device of the present application is particularly suitable for corneal cross-linking surgery. The gas-releasing layer and microneedle structure provided in the fluid delivery device of the present application cooperate with each other, allowing the oxygen generated by the gas-releasing layer to pass directly through the microneedle structure to the corneal stroma, where it is easily and rapidly absorbed by the cornea, thereby improving the efficiency of corneal cross-linking and achieving a higher oxygen utilization rate than oxygen supply methods inside eye masks or face masks. The fluid delivery device of the present application improves drug delivery efficiency and significantly reduces the difficulty of performing corneal cross-linking surgery.

[0049] The fluid delivery device of the present application can be manufactured as a disposable device.

[0050] Other features and advantages of the present application will be described in the following description, and in part will become apparent from the description, or will be understood by practicing the present application. Other advantages of the present application can be realized and obtained by the solutions described in the description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] 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.

[0052] Figure 1 This is a schematic structural diagram of a fluid delivery device provided according to one embodiment of the present application;

[0053] Figure 2 Schematic diagram of the structure of a microneedle in a fluid delivery device according to one embodiment of the present application;

[0054] Figure 3 A schematic structural diagram of a fluid delivery device according to another embodiment of the present application; and

[0055] Figure 4 for Figure 3 The schematic diagram of the top view of the fluid delivery device is shown. DETAILED DESCRIPTION

[0056] To make the purpose, technical solutions and advantages of this application more clear, the embodiments of this application are described in detail below. It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of this application can be combined with each other in any way.

[0057] The present application provides a fluid delivery device for the eye, comprising a first component; a second component connected to the first component and forming a fluid-tight chamber with the first component, the chamber being suitable for containing a drug solution to be delivered; a plurality of microneedles penetrating the first component, the microneedles being configured to establish a fluid delivery channel between the first component and the area to be treated in the eye that is fluidically connected to the chamber when the first component is attached to the subject's eye; and a gas release layer located in the chamber, the gas release layer being configured to release gas into the chamber.

[0058] Figure 1 FIG. 1 is a schematic structural diagram of a fluid delivery device according to an embodiment of the present application. Figure 1 The ocular fluid delivery device 1 may include a first component 10, a second component 20, a chamber 30 located between the first and second components 10, 20, a plurality of microneedles 40, and a gas-releasing layer 50. The first component 10 may have an outer surface facing the subject's eye and an inner surface facing away from the subject's eye, and the first component 10 may be flexible to fit the subject's eye. 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. The plurality of microneedles 40 are disposed through the first component 10. When the first component 10 is attached to the subject's eye, a fluid delivery channel in fluid communication with the chamber is established between the first component 10 and the area to be treated in the patient's eye through the plurality of microneedles 40. The gas-releasing layer 50 may be located within the chamber 30, such as being disposed on the first component 10 or the second component 20. The gas-releasing layer 50 may be configured to release gas into the chamber 30.

[0059] Figure 1 The illustrated fluid delivery device 1 can be adapted for use in corneal cross-linking procedures to treat the cornea of ​​an eye. Microneedles 40 can be positioned in the central region of the first component 10, and the gas-releasing layer 50 can be positioned on the periphery of the first component 10, partially or completely surrounding the plurality of microneedles 40. However, in other embodiments, depending on the area of ​​the eye to be treated, such as the iris or sclera, the placement of the microneedles and the gas-releasing layer can be adapted as needed, and this description will not be repeated herein.

[0060] The first component 10 can be flexible to conform to the subject's eye, and thus can be made of a flexible transparent material that is impermeable to water and air but transparent to ultraviolet light, such as silicone or hydrogel, for example, short-term implant grade silicone rubber Med-6015 material.

[0061] In the present application, the first component 10 may also be made of polymethyl methacrylate (PMMA) compatible with the 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 set to achieve better stability of the microneedle base.

[0062] The second component 20 may also be flexible and made of a flexible transparent material that is impermeable to water and air but transparent to ultraviolet light, such as silicone or hydrogel, for example, short-term implant grade silicone rubber Med-6015 material.

[0063] use Figure 1 With the fluid delivery device shown, a physician can utilize a fixed or mobile light source within the operating room to illuminate the treatment area and the gas-releasing layer separately, and perform the corresponding treatment procedure. The light source can generally be divided into two groups, each generating ultraviolet light of different wavelengths through a first component and a second component. One group can be used to illuminate a drug solution, such as a riboflavin solution used in corneal cross-linking surgery, at the treatment area, while the other group can be used to illuminate the gas-releasing layer.

[0064] In the present application, the materials used for the first component and the second component can 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.

[0065] The first component 10 and the second component 20 can be connected by curing molding, such as by curing molding using an optical-grade contact lens metal mold to connect the two to obtain a fluid-tight chamber 30.

[0066] The orthographic projections of the first component 10 and the second component 20 on the horizontal plane may be circular or elliptical.

[0067] The microneedle array mold can be manufactured using photolithography technology to ensure that the mold has the fine structure of the microneedles. For example, the selected microneedle material can be injected into the mold, and the microneedle structure can be formed through a process such as hot pressing or solvent evaporation. The microneedle array can then be dried and demolded.

[0068] The microneedle 40 can be in the form of a microneedle with a flow channel inside or a dissolving microneedle. The one or more fluid channels provided in the microneedle can be used to deliver drug solutions and gases. If the microneedle is 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 for delivering 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. 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 channels for delivering drug solutions and gases.

[0069] The size, length, and distribution of the fluid channels within the microneedle structure can be adjusted to ensure adequate drug and oxygen delivery. The shape of the fluid channels can also be modified, such as to make them curved or straight. Figure 2 It is shown that the fluid channel 41 can be a plurality of curved fluid channels.

[0070] 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.

[0071] Before fixing the microneedle array on 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.

[0072] The fluid delivery device of this application can utilize a microneedle structure as a channel for drug and oxygen delivery. Microneedle structures offer numerous advantages, including minimal invasiveness, minimal complex manipulation, strong biocompatibility, and the ability to cross the corneal epithelium. Microneedles can be fabricated from a variety of materials, including silicon, polymethyl vinyl ether and maleic anhydride (PMVE / MA), polymethyl methacrylate (PMMA), polylactic acid (PLA), and metals such as stainless steel, titanium, and nickel. Polymethyl methacrylate (PMMA) is the preferred material for microneedles.

[0073] 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 method of adding drugs drop by drop. For example, before corneal cross-linking surgery, it took about 30 minutes for specialized medical staff to perform drug dripping, while the delivery device of the present application can save the time of drug dripping before surgery. After the delivery device of the present application is placed in the subject's eye, the drug can be released automatically with the help of its microneedle structure; the corneal epithelial barrier was difficult to cross in the past, but 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 performing corneal cross-linking surgery. Therefore, it is particularly suitable for corneal cross-linking surgery in grassroots or remote hospitals, so that a wider range of patients can benefit.

[0074] The gas-releasing layer 50 of the present application can be a mixture of a titanium dioxide (TiO2) film and water, encapsulated in a waterproof, breathable film. The waterproof, breathable film can be made of, for example, a polytetrafluoroethylene (PTFE) microporous membrane, which is permeable only to oxygen and free radicals but not to pre-stored pure water. The thickness of the titanium dioxide film can be in the range of 200 μm to 400 μm, such as 350 μm.

[0075] Because the gas-releasing layer of this application utilizes a TiO2 thin film, the TiO2 surface undergoes non-adiabatic lattice motion, including two phases: expansion and recovery. This lattice motion promotes water dissociation to produce oxygen, which is then transported to the corneal stroma via the microneedle structure.

[0076] Since the gas release layer of the present application adopts TiO2 thin film, it can be stored for a long time at room temperature away from light; its ultraviolet light absorption properties can be used to protect corneal epithelial stem cells at the corneal limbus, preventing stem cell damage caused by the patient's eye rotation during surgery; its antibacterial activity can be used for hypoxic corneal bacterial infection diseases.

[0077] In addition, the gas-releasing 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 unwanted reactions because it covers part of the corneal area.

[0078] A gas-releasing layer 50, such as a TiO2 film, can be deposited on the inner surface of the first component using a pulsed magnetron sputtering method. Specific steps include cleaning the inner surface of the first component with anhydrous ethanol, ultrasonically cleaning the glass surface to be plated using a 5% neutral detergent solution, rinsing the glass surface with deionized water, and drying. The TiO2 film is deposited using a coating machine. A pure Ti cylindrical target and a DC pulsed power supply are used, and the coating conditions are a vacuum of 2×10 -3 Pa, and the deposition power is 5-20 kW.

[0079] In addition to TiO2, the gas-releasing layer 50 can be made of a variety of materials. For example, hydrogels can be used as carriers of oxygen dissolved in water (e.g., microalgae, perfluorocarbons, hemoglobin, etc.). Materials such as calcium peroxide nanoparticles or hydrogels can be prepared by utilizing the ability of calcium peroxide to generate oxygen when in contact with water.

[0080] 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.

[0081] The components of the fluid delivery device 1 of the present application can be encapsulated in a variety of ways. For example, the encapsulation methods may include: injecting a silicone rubber solution and a curing agent into a mold, vacuum degassing, curing and heating to form a first component and a second component; after curing, using a CO2 laser cutter or drilling equipment to drill a regularly arranged array of holes in the first component, then attaching the microneedle structure to the holes for encapsulation; shaping a gas-releasing 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; and finally, sealing the first component and the second component to form a chamber, and injecting a drug solution, such as a riboflavin solution, into the chamber.

[0082] 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).

[0083] The fluid delivery device of the present application can be manufactured for single use.

[0084] The present application also provides a fluid delivery device for the eye, comprising a first component; a second component, which is 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 treated area 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 onto the gas release layer and the treated area; 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 to control the pressure in the chamber within the range of 2kPa-10kPa.

[0085] Figure 3FIG. 1 is a schematic structural diagram of a fluid delivery device according to another embodiment of the present application. Figure 3 The ocular fluid delivery device 1' of the present application may include a first component 100, a second component 200, a chamber 300 located between the first and second components 100, 200, a plurality of microneedles 400, a gas-releasing 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 subject's eye and an inner surface facing away from the subject's eye. The first component 100 may be flexible to conform to the subject's eye. The second component 200 may be connected to the first component 100 and form a fluid-tight seal with the chamber 300. The chamber 300 may be suitable for containing a drug solution to be delivered. The plurality of microneedles 400 are disposed through the first component 100. When the first component 100 is in contact with the subject's eye, the plurality of microneedles 400 establish a fluid delivery channel between the first component 100 and the area to be treated in the patient's eye, in fluid communication with the chamber. The gas-releasing layer 500 may be located within the chamber 300, such as by being disposed on the first component 100. The gas-releasing layer 500 may be configured to release gas into the chamber 300. The light source 600 may be located within the chamber 300 and disposed on the second component 200, and may be disposed opposite the gas-releasing layer 500. The light source 600 is adapted to irradiate light toward the gas-releasing layer 500 and the area to be treated, such as the cornea, to induce a corneal cross-linking reaction. The sensor 700 may be located within the chamber 300. The sensor 700 may be adapted to measure and transmit data regarding environmental parameters within the chamber 300. The processing unit 800 may be located within the chamber 300. The processing unit 800 may be adapted to receive data transmitted by the sensor 700 and control the on and off of the light source 600 based on the received data.

[0086] 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 be an ellipse or other shapes.

[0087] The light source 600 can be disposed within the encapsulated waterproof and breathable membrane, which can be attached to the second component 200 by adhesion or other means. In this application, the light source 600 can be a plurality of LED lights, 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 can also be located in the circumferential region of the second component in an annular shape, 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.

[0088] Light source 600 can irradiate light toward both the drug solution in the treatment area and the gas-releasing layer. For example, light source 600 can be divided into two groups of LED lights. One group of LED lights is used to irradiate the treatment area, such as irradiating a riboflavin solution in the cornea to induce corneal cross-linking. The other group of LED lights is used to irradiate the gas-releasing layer with ultraviolet light in the range of 360-380 nm to cause the gas-releasing layer to release oxygen.

[0089] The sensor 700 can be disposed within the encapsulated waterproof and breathable membrane to monitor in real time the pressure and concentration of the gas (e.g., oxygen) within the chamber 300 connected to the microneedles. The sensor 700 can be capacitive, resistive, or ionization type.

[0090] The control unit 800 can be disposed within the encapsulated waterproof, breathable membrane. The control unit 800 can be connected to the sensor 700 and the light source 600 via wired or wireless communication. For example, the control unit 800 can receive real-time oxygen pressure data within the chamber from the sensor and dynamically control and adjust the light source based on changes in this pressure data. Control methods include, but are not limited to, turning on or off a set of LED lights illuminating the gas release layer to extend or shorten the illumination time, thereby accelerating or slowing gas release.

[0091] In the present application, the control unit 800 may use a microcontroller unit (MCU), a field programmable gate array (FPGA), or the like to implement the above functions.

[0092] The present application also provides a method for delivering a drug solution and oxygen to the eye using the aforementioned fluid delivery device. The method may include attaching the fluid delivery device to a subject's eye; piercing a portion of the subject's eye to be treated, such as the cornea, with a plurality of microneedles, so that the drug solution contained in the chamber is delivered to the portion to be treated via the microneedles; applying ultraviolet light in the range of 360-370 nm to the drug solution; and applying ultraviolet light in the range of 360-380 nm to the gas-releasing layer to release oxygen, so that the oxygen is delivered to the portion to be treated via the microneedles.

[0093] When the fluid delivery device in the present application is used in corneal cross-linking surgery, the usage process may include a user, such as a doctor, taking out the fluid delivery device, which is stored in a dark brown or opaque medicine box and immersed in a riboflavin solution in the dark, and the fluid-filled device is already filled with riboflavin solution; after taking it out, gently placing the device on the center of the patient's cornea and confirming that it is well positioned; instructing the patient to directly and slowly close their eyes or use a contact lens suction stick to lightly press the middle of the device and then close their 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 essentially completely infiltrated with riboflavin, the patient is instructed to open their eyes and irradiate with 360-370nm ultraviolet light for corneal cross-linking. Simultaneously, a 360-380nm LED light is used to illuminate the gas-releasing layer, causing the TiO2 to photocatalytically release oxygen, providing the oxygen required for the corneal cross-linking reaction. The generated gas further propels the residual riboflavin into the cornea, while subsequently generating oxygen to replenish the oxygen consumed in the cross-linking reaction. Simultaneously, a sensor detects changes in pressure within the chamber in real time and coordinates with a control unit to dynamically adjust the on and off of the set of LED lights used to illuminate the gas-releasing layer, extending or shortening the irradiation time accordingly. This prevents excessive gas pressure from damaging the patient's cornea or excessively low gas pressure from compromising drug solution delivery. After treatment is complete, the fluid delivery device is removed, and the patient's eyes are treated with conventional antibiotic eye ointment and covered with a bandage lens.

[0094] 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 use in the 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 passing through the first component, wherein the microneedles are configured to establish a fluid delivery channel between the first component and a site to be treated in the eye that is in fluid communication with the chamber when the first component is attached to the eye of a subject; A gas release layer is located in the chamber and is configured to release gas into the chamber.

2. The fluid delivery device according to claim 1, wherein At least one fluid delivery channel is provided in the microneedle.

3. The fluid delivery device according to claim 2, wherein 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 set in the microneedle.

4. The fluid delivery device according to claim 1, wherein The microneedles are configured to dissolve or be absorbed by eye tissue after being inserted into the area to be treated, so that the channels formed by the microneedles inserted into the area to be treated form the fluid delivery channels.

5. The fluid delivery device according to claim 1, wherein Materials used for the gas-releasing layer include titanium dioxide, calcium peroxide, and hydrogel.

6. The fluid delivery device according to claim 5, wherein: 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.

7. The fluid delivery device according to claim 1, wherein The first component is flexible so as to be adapted 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, wherein: The material used for the first member and the second member is silicone, hydrogel or polymethyl methacrylate.

9. The fluid delivery device according to claim 7, wherein: The gas-releasing 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 passing through the first component, wherein the microneedles are configured to establish a fluid delivery channel between the first component and a site to be treated in the eye that is in fluid communication with the chamber when the first component is attached to the eye of a subject; a gas release layer located in the cavity and disposed in a circumferential region of the first component, the gas release layer being configured to release gas into the cavity; a light source located in the chamber and disposed on the second component, the light source being adapted to irradiate light toward the gas-releasing layer and the area 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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