Riboflavin iontophoresis device

Abstract

The utility model provides a kind of riboflavin ion introduction device, it is applied to corneal crosslinking technique.The device includes corneal applicator and micro-current controller;The corneal applicator includes liquid accumulator, negative electrode net and electric connector;The bottom of the liquid accumulator is equipped with the lamination surface for lamination cornea, and the upper end of liquid accumulator is formed with the dosing port;The negative electrode net is inlaid in liquid accumulator, and is contacted with riboflavin solution;The electric connector is located at the outer side wall of the liquid accumulator, and is communicated with the negative electrode net;The micro-current controller is electrically connected with negative electrode net by electric connector.The utility model is based on the negative charge characteristics of corneal epithelial surface, uses electric field effect to improve the diffusion speed and penetration efficiency of riboflavin in corneal tissue, to effectively solve the problem of long soaking time and low penetration efficiency of riboflavin in the prior art.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology and relates to a riboflavin iontophoresis device. Background Technology

[0002] Corneal cross-linking (CXL) is an effective treatment for ectopic keratopathy. It utilizes the synergistic effect of ultraviolet radiation and riboflavin to promote the formation of a tighter cross-linked structure between collagen fibers in the corneal stroma, thereby enhancing the overall strength and stability of the cornea.

[0003] Traditional corneal cross-linking procedures mainly include de-epithelialization and transepithelialization. De-epithelialization, because it involves scraping away the corneal epithelium, has a longer recovery period and causes more significant pain and discomfort for patients. Furthermore, the loss of the corneal epithelium exposes the corneal surface, increasing the risk of postoperative infection. In contrast, transepithelialization, as a non-invasive corneal cross-linking method, significantly reduces postoperative pain and discomfort and minimizes the risk of infection due to the loss of the corneal epithelium.

[0004] However, the characteristic of transepithelial surgery (TES) that does not remove the corneal epithelium means that riboflavin requires a longer soaking time in the cornea, thus increasing the operation time and patient discomfort during the procedure. More importantly, because the cornea has a strong restriction on large molecules, allowing only small molecules to pass through, it becomes a natural barrier to large molecules, such as riboflavin solution, thus affecting the penetration of riboflavin and ultimately leading to less than ideal treatment results. Summary of the Invention

[0005] The purpose of this invention is to provide a riboflavin iontophoresis device to solve the problems of excessively long corneal soaking time and poor penetration effect in the prior art.

[0006] This invention provides a riboflavin iontophoresis device for use in corneal cross-linking surgery, comprising a corneal drug delivery device and a microcurrent controller: the corneal drug delivery device includes a reservoir for storing riboflavin solution, a negative electrode mesh, and an electrical connector; the bottom of the reservoir has an adhesion surface for adhering to the cornea, and the upper end of the reservoir forms a drug delivery port; the negative electrode mesh is embedded in the reservoir and is in contact with the riboflavin solution in the reservoir; the electrical connector is located on the outer wall of the reservoir and communicates with the negative electrode mesh; the microcurrent controller is electrically connected to the negative electrode mesh through the electrical connector.

[0007] In one embodiment of this utility model, the negative electrode mesh is arranged parallel to the bonding surface, and the negative electrode mesh, the bonding surface, and the side wall of the reservoir enclose a riboflavin electrophoresis region.

[0008] In one embodiment of the present invention, the corneal drug delivery device further includes an exhaust pipe, a drainage pipe, a first Luer lock connector, a second Luer lock connector, and a water-stop clamp; one end of the exhaust pipe is connected to the riboflavin electrophoresis region, and the other end is fixedly connected to the first Luer lock connector; one end of the drainage pipe is connected to the riboflavin electrophoresis region, and the other end is fixedly connected to the second Luer lock connector; the water-stop clamp is disposed in the middle of the exhaust pipe.

[0009] In one embodiment of the present invention, the corneal drug delivery device further includes a first syringe, a second syringe, and a third syringe; the first syringe is threadedly connected to a first Luer lock connector; the second syringe is used to inject riboflavin solution into the corneal drug delivery device from the drug delivery port so that the riboflavin solution immerses the negative electrode mesh; the third syringe is threadedly connected to a second Luer lock connector.

[0010] In one embodiment of the present invention, the microcurrent controller is provided with a user interface for setting current parameters and modes.

[0011] In one embodiment of the present invention, the microcurrent controller includes a control component and a cable; the control component is used to output a corresponding microcurrent based on the current parameters and mode set by the user; one end of the cable is electrically connected to the control component, and the other end includes a positive electrode patch and a negative electrode connector, wherein the positive electrode patch is attached to the patient's forehead, and the negative electrode connector is electrically connected to the negative electrode network through the electrical connector.

[0012] In one embodiment of this utility model, the positive electrode patch is made of a conductive material.

[0013] In one embodiment of the present invention, the bonding surface is annular and concentrically aligned with the cornea.

[0014] In one embodiment of this utility model, the electrical connector, the liquid reservoir, and the negative electrode mesh are integrated into one structure.

[0015] As described above, the riboflavin iontophoresis device of this invention is based on the negative charge characteristics of the corneal epithelial surface and uses the electric field to improve the diffusion rate and penetration efficiency of riboflavin in corneal tissue, thereby effectively solving the problems of long riboflavin immersion time and low penetration efficiency in the prior art. Attached Figure Description

[0016] Figure 1The diagram shown is a structural schematic of one embodiment of the riboflavin iontophoresis device of this invention.

[0017] Figure 2 The diagram shown is a structural schematic of the corneal delivery device according to an embodiment of the present invention.

[0018] Figure 3 The diagram shown is a structural schematic of another embodiment of the corneal delivery device of this utility model.

[0019] Figure 4 The diagram shown is a structural diagram of the corneal delivery device according to another embodiment of the present invention.

[0020] Figure 5 The diagram shown is a structural schematic of the first syringe according to an embodiment of the present invention.

[0021] Figure 6 The diagram shown is a structural schematic of the microcurrent controller described in this utility model in one embodiment.

[0022] Component designation explanation

[0023] 100 Corneal Delivery Device

[0024] 101 Liquid Reservoir

[0025] 102 Negative Electrode Grid

[0026] 103 Electrical Connector

[0027] 104 Exhaust Pipe

[0028] 105 drain pipe

[0029] 106 First Luer Lock Connector

[0030] 107 Second Luer Lock Connector

[0031] 108 Waterstop Clamp

[0032] 109 First Syringe

[0033] 200 Microcurrent Controller

[0034] 201 Control Component

[0035] 202 cable

[0036] 2021 Positive Patch

[0037] 2022 Negative Terminal Detailed Implementation

[0038] The following specific examples illustrate the implementation of this utility model. Those skilled in the art can easily understand other advantages and effects of this utility model from the content disclosed in this specification. This utility model can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of this utility model. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0039] It should be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show the components related to the present invention and are not drawn according to the number, shape and size of the components in actual implementation. In actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.

[0040] Furthermore, in this utility model, descriptions involving "first," "second," etc., are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. Additionally, the technical solutions of the various embodiments can be combined with each other, but only on the basis of being achievable by those skilled in the art. When the combination of technical solutions is contradictory or impossible to implement, such a combination of technical solutions should be considered non-existent and not within the scope of protection claimed by this utility model.

[0041] The cornea, as one of the important biological membranes of the human eye, has epithelial cells rich in negatively charged components such as glycosaminoglycans (e.g., hyaluronic acid in the corneal stroma) and sulfated glycosaminoglycans. These components can generate electrostatic interactions with surrounding cations, thus giving the corneal epithelial surface a negatively charged characteristic. The sclera, another important biological membrane of the human eye, together with the cornea, forms the eyeball wall. Proteins and glycosaminoglycans within the sclera can exhibit a certain degree of negative charge, especially when interacting with drugs or electric fields, affecting the drug's penetration per unit time and overall penetration effect. When the cornea is damaged or certain diseases cause changes in corneal permeability, the sclera can serve as an important drug penetration route.

[0042] The following embodiments of this invention provide a riboflavin iontophoresis device that can be applied to corneal cross-linking. Based on the negative charge characteristics of the corneal epithelial surface, the riboflavin iontophoresis device utilizes an electric field to enhance the diffusion rate and penetration efficiency of riboflavin in corneal tissue, thereby effectively solving the problems of long riboflavin immersion time and low penetration efficiency in existing technologies.

[0043] The principle and implementation method of the riboflavin iontophoresis device described in the embodiments of this utility model will be explained in detail below with reference to the accompanying drawings, so that those skilled in the art can understand the riboflavin iontophoresis device described in the embodiments of this utility model without creative effort.

[0044] Please see Figure 1 The image shows a schematic diagram of the riboflavin iontophoresis device according to one embodiment of the present invention. Figure 1 As shown in the figure, the riboflavin iontophoresis device provided in this embodiment of the present invention includes a corneal drug delivery device 100 and a microcurrent controller 200. The dashed lines in the figure are used to indicate the connection between the corneal drug delivery device 100 and the microcurrent controller 200.

[0045] Please see Figure 2 The image shows a schematic diagram of the corneal delivery device according to one embodiment of the present invention. Figure 2 As shown, the corneal delivery device 100 includes a reservoir 101 for storing riboflavin solution, a negative electrode mesh 102, and an electrical connector 103.

[0046] In one embodiment of the present invention, the bottom of the reservoir 101 is provided with an adhesion surface for adhering to the cornea, and the upper end of the reservoir 101 is formed with an administration port.

[0047] Specifically, the adhesive surface is annular and concentrically aligned with the cornea. This implementation helps ensure that riboflavin is evenly distributed across the entire corneal surface, reducing drug loss to non-target areas while increasing drug concentration in the target area.

[0048] The size of the adhesive surface is matched to the patient's corneal diameter. This means that the riboflavin iontophoresis device provided by this invention can adapt to different patients' eye sizes, providing personalized treatment.

[0049] During riboflavin iontophoresis, the adhesive surface must tightly cover the corneal surface. Through the administration port, the doctor can directly inject riboflavin into the reservoir 101, after which the riboflavin is evenly released into the cornea via the adhesive surface. This design simplifies the administration process, making drug release more direct and efficient.

[0050] In one embodiment of the present invention, the negative electrode mesh 102 is embedded in the liquid reservoir 101 and is in contact with the riboflavin solution in the liquid reservoir 101.

[0051] Specifically, the negative electrode mesh 102 is arranged parallel to the bonding surface, and the negative electrode mesh 102, the bonding surface, and the sidewall of the reservoir 101 enclose a riboflavin electrophoresis region.

[0052] In this implementation, an electrophoresis operation is performed by creating a riboflavin electrophoresis region. The purpose is to limit the application range of the riboflavin solution and prevent the drug from leaving the area where it needs to be applied.

[0053] In one embodiment of this utility model, the electrical connector 103 is disposed on the outer side wall of the liquid reservoir 101 and communicates with the inner negative electrode mesh. This implementation ensures that the electrical connector 103 does not interfere with the internal structure or function of the liquid reservoir 101, while facilitating connection with other devices.

[0054] Specifically, the electrical connector 103 is an integral part of the liquid reservoir 101 and the negative electrode mesh 102. The electrical connector 103 and the liquid reservoir 101 can be made of the same material and can be formed in one piece through injection molding or other manufacturing processes. This design improves the overall structural strength and stability, reducing problems caused by loose connections or damage.

[0055] The height of the electrical connector 103 is aligned with the side wall of the reservoir 101. This design helps maintain the overall aesthetics of the device while also facilitating installation and maintenance.

[0056] Please see Figure 3 The diagram shown is a structural diagram of the corneal drug delivery device according to another embodiment of the present invention. Figure 3 As shown, the corneal delivery device 100 also includes an exhaust pipe 104, a drainage pipe 105, a first Luer lock connector 106, a second Luer lock connector 107, and a water-stopping clamp 108.

[0057] In one embodiment of the present invention, one end of the exhaust pipe 104 is connected to the riboflavin electrophoresis region, and the other end is fixedly connected to the first Luer lock connector 106.

[0058] A Luer lock connector is a standardized interface that allows for easy connection and disconnection from other medical devices, such as syringes and infusion pumps. The first Luer lock connector 106 described in this invention allows the user to control the venting process via a syringe. Before riboflavin administration, the syringe and vent tube 104 are used to evacuate air from the riboflavin electrophoresis area, creating negative pressure conditions that ensure the adhesive surface adheres tightly to the corneal surface, reducing drug loss to non-target areas.

[0059] In one embodiment of the present invention, one end of the drain pipe 105 is connected to the riboflavin electrophoresis region, and the other end is fixedly connected to the second Luer lock connector 107.

[0060] The drain pipe 105 is used to drain the remaining riboflavin solution from the riboflavin electrophoresis area after the electrophoresis process is completed, to prevent solution residue from affecting the next use.

[0061] Similar to the first Luer lock connector 106, the second Luer lock connector 107 also provides a standardized interface and allows the user to control the discharge process through its syringe, ensuring that the riboflavin solution is completely discharged from the riboflavin electrophoresis area and keeping the device clean.

[0062] Please see Figure 4 This is a structural diagram of another embodiment of the corneal drug delivery device described in this utility model. Figure 4 As shown, the water-stopping clamp 108 is located in the middle of the exhaust pipe 104.

[0063] By closing or opening the water-stop clamp 108, the user can control the opening and closing of the exhaust pipe 104, thereby regulating the pressure and airflow within the riboflavin electrophoresis area.

[0064] It should be noted that the structural design of this utility model does not include a water-stop clamp on the drain pipe 105. The principle behind this design is that when negative pressure is applied to the riboflavin electrophoresis area using a syringe and exhaust pipe 104, the contact surface at the bottom of the reservoir 101 forms a tight seal with the surface of the eyeball, generating an adsorption effect under negative pressure. Under this physical state, the liquid inside the reservoir 104 cannot flow out naturally through the drain pipe 105 due to the pressure difference, thus ensuring liquid control and safety during operation.

[0065] In one embodiment of this utility model, the corneal delivery device 100 further includes a first syringe 109, a second syringe, and a third syringe. See also... Figure 5 The image shows a schematic diagram of the structure of the first syringe described in this utility model in one embodiment.

[0066] In one embodiment of the present invention, the first syringe 109 is threadedly connected to the first Luer lock connector 106.

[0067] Specifically, the first syringe 109 is a medical vacuum syringe with a Luer connector. This invention, by precisely controlling the piston position of the first syringe 109, can effectively adjust the pressure between the contact area and the ocular surface.

[0068] In one embodiment of the present invention, the second syringe is used to inject riboflavin solution into the corneal delivery device 100 through the delivery port, so that the riboflavin solution immerses the negative electrode mesh 102.

[0069] In one embodiment of the present invention, the third syringe is threadedly connected to the second Luer lock connector 107.

[0070] Specifically, the third syringe is a medical vacuum syringe with a Luer connector. After the electrophoresis procedure is completed, the third syringe is used to drain the remaining riboflavin solution from the riboflavin electrophoresis area.

[0071] In one embodiment of the present invention, the microcurrent controller 200 is electrically connected to the negative electrode network 102 via the electrical connector 103.

[0072] Please see Figure 6 The image shows a schematic diagram of the microcurrent controller 200 described in one embodiment of this utility model. Figure 6 As shown, the microcurrent controller 200 includes a control component 201 and a cable 202.

[0073] Specifically, the microcurrent controller 200 is equipped with a user interface for setting current parameters and modes. For example, the user interface can be a knob, dial, or digital input interface. Through the user interface, the user can adjust the magnitude of the generated current, the mode, the electrophoresis duration, or other relevant parameters.

[0074] The control component 201 is used to output a corresponding microcurrent based on the current parameters and mode set by the user.

[0075] Specifically, the control component 201 is an internal chip circuit combination belonging to the microcurrent controller 200.

[0076] One end of the cable 202 is electrically connected to the control component 201, and the other end includes a positive electrode patch 2021 and a negative electrode connector 2022, wherein the positive electrode patch 2021 is attached to the patient's forehead, and the negative electrode connector 2022 is electrically connected to the negative electrode network 102 through the electrical connector 103.

[0077] In one embodiment of this utility model, the positive electrode patch 2021 is made of a conductive material. The conductive material is capable of efficiently transmitting microcurrents.

[0078] In one embodiment of this invention, the riboflavin iontophoresis device further includes an eyelid opener. The eyelid opener is used to maintain the patient's eyelids open before drug administration, thereby significantly reducing the risk of treatment interruption or uneven drug distribution due to blinking or natural eyelid closure. This design enhances the continuity and effectiveness of treatment.

[0079] It should be noted that this utility model protects the hardware system architecture, which is related to the structure, components, positional relationship, connection relationship and cooperative working relationship between the corneal delivery device 100 and the microcurrent controller 200, and does not include any software improvements.

[0080] The following will describe in detail the usage process of the riboflavin iontophoresis device of this utility model with reference to the embodiments.

[0081] In the preparation phase, the patient is first given local anesthesia for the eye. Then, the patient's head position is adjusted to ensure the eye to be treated is horizontal. Additionally, an eyelid speculum is used to maintain the eyelid open.

[0082] It is important to note that because the absorption spectra of riboflavin and fluorescein are very similar, fluorescein should be avoided before treatment begins. Additionally, considering that some antibiotics may compete with riboflavin for absorption, it is recommended to discontinue any topical antibiotic medications at least 24 hours before iontophoresis with riboflavin.

[0083] During the operation phase, the corneal delivery device 100 must first be precisely positioned in the corneal area to be treated. This includes connecting the Luer connector of the first syringe 109 to the first Luer lock adapter, ensuring a tight connection; simultaneously, connecting the Luer connector of the third syringe to the second Luer lock adapter, also ensuring a locked state. Confirm that the sealing clip 108 is in the open position. Gently place the adhesive surface at the bottom of the reservoir 101 onto the patient's corneal surface, observing from multiple angles to ensure that the adhesive surface is perfectly aligned with the corneal center. Use the first syringe 109 to perform a slight aspiration motion to expel air from the riboflavin electrophoresis area. At this point, a negative pressure environment is created between the adhesive surface and the cornea, resulting in a gapless fit. Then, close the sealing clip 108 to maintain this state. After drawing an appropriate amount of riboflavin solution using the second syringe, inject it into the riboflavin electrophoresis area through the delivery port until the riboflavin solution completely covers the entire negative electrode grid.

[0084] Before connecting the microcurrent controller 200 to the corneal applicator 100, ensure that the microcurrent controller 200 is in the off state. Next, supply the microcurrent required for electrophoresis to the corneal applicator 100 through the microcurrent controller 200. Specifically, connect one end of the cable 202 to the control component 201, and connect the negative terminal 2022 of the other end to the electrical connector 103. After cleaning the patient's forehead, attach the anode patch at the other end of the cable 202 to the forehead area above the patient's eye. Turn on the microcurrent controller 200 and set the required current parameters and electrophoresis duration through the microcurrent controller 200's interface. Based on these preset parameters, the electrophoresis process will begin in the riboflavin electrophoresis area. Immediately turn off the microcurrent controller 200 after the electrophoresis procedure is complete. Then, use a third syringe to draw the remaining riboflavin solution from the reservoir 101 and drain it from the device through the drain tube 105. After confirming that all residual riboflavin solution has been completely removed, open the water stop clamp 108 to allow air to enter the riboflavin electrophoresis area.

[0085] Finally, carefully remove the corneal delivery device 100 and disconnect the microcurrent controller 200 from one end of the cable 202. Simultaneously, detach the negative terminal 2022 at the other end of the cable 202 from the electrical connector 103 and remove the anode patch from the patient's forehead, thus concluding the entire procedure.

[0086] It should be noted that the riboflavin iontophoresis device provided by this invention needs to be used in conjunction with an ultraviolet light source. When ultraviolet light acts on the riboflavin that has penetrated into the cornea, it can promote a cross-linking reaction between corneal collagen fibers, thereby improving the overall strength and stability of the cornea.

[0087] Specifically, after iontophoresis with riboflavin, the cornea can be irradiated with ultraviolet light of a specific wavelength. Different doses and irradiation modes can be selected to optimize the treatment effect based on clinical needs. The cross-linking reaction that occurs during this process refers to the formation of covalent bonds that link collagen molecules together, thereby constructing a more compact and stable three-dimensional structure. This structural change not only significantly enhances the stability and mechanical strength of the corneal stroma but also reduces the elasticity of the cornea itself, increasing its resistance to deformation and ultimately improving the biomechanical properties of the cornea, showing potential efficacy in treating ectopic keratopathy.

[0088] In traditional perepithelial corneal surgery, the riboflavin penetration process typically takes about 30 minutes to ensure its uniform distribution in the corneal stroma. However, in corneal cross-linking surgery involving the riboflavin iontophoresis device described in this invention, riboflavin penetration is achieved through iontophoresis technology, achieving an efficiency up to twice that of traditional methods.

[0089] The descriptions of the processes or structures corresponding to the above figures each have their own emphasis. For parts of a process or structure that are not described in detail, please refer to the relevant descriptions of other processes or structures.

[0090] The above embodiments are merely illustrative of the principles and effects of this utility model and are not intended to limit the scope of this utility model. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of this utility model. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in this utility model should still be covered by the claims of this utility model.

Claims

1. A riboflavin iontophoresis device applied to corneal cross-linking, characterized by, Includes corneal drug delivery device and microcurrent controller: The corneal drug delivery device includes a reservoir for storing riboflavin solution, a negative electrode mesh, and an electrical connector; the bottom of the reservoir has an adhesion surface for adhering to the cornea, and the upper end of the reservoir forms a drug delivery port; the negative electrode mesh is embedded in the reservoir and is in contact with the riboflavin solution in the reservoir; the electrical connector is located on the outer wall of the reservoir and communicates with the negative electrode mesh; The microcurrent controller is electrically connected to the negative electrode network via the electrical connector.

2. The apparatus of claim 1, wherein, The negative electrode mesh is arranged parallel to the bonding surface, and the negative electrode mesh, the bonding surface, and the side wall of the reservoir enclose a riboflavin electrophoresis region.

3. The apparatus of claim 2, wherein, The corneal delivery device also includes an exhaust tube, a drainage tube, a first Luer lock connector, a second Luer lock connector, and a water-stop clamp; One end of the exhaust pipe is connected to the riboflavin electrophoresis region, and the other end is fixedly connected to the first Luer lock connector; One end of the drain pipe is connected to the riboflavin electrophoresis region, and the other end is fixedly connected to the second Luer lock connector; The water-stop clamp is installed in the middle of the exhaust pipe.

4. The apparatus of claim 3, wherein, The corneal delivery device also includes a first syringe, a second syringe, and a third syringe; The first syringe is threadedly connected to the first Luer lock connector; The second syringe is used to inject riboflavin solution into the corneal applicator through the administration port, so that the riboflavin solution immerses the negative electrode mesh; The third syringe is threadedly connected to the second Luer lock connector.

5. The apparatus of claim 1, wherein, The microcurrent controller is equipped with a user interface for setting current parameters and modes.

6. The apparatus of claim 5, wherein, The microcurrent controller includes control components and cables; The control component is used to output a corresponding microcurrent based on the current parameters and mode set by the user; One end of the cable is electrically connected to the control component, and the other end includes a positive electrode patch and a negative electrode connector, wherein the positive electrode patch is attached to the patient's forehead, and the negative electrode connector is electrically connected to the negative electrode network through the electrical connector.

7. The apparatus of claim 6, wherein, The positive electrode patch is made of conductive material.

8. The apparatus of claim 1, wherein, The bonding surface is annular and concentrically aligned with the cornea.

9. The apparatus of claim 1, wherein, The electrical connector is an integral part of the liquid reservoir and the negative electrode mesh.

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