A posterior scleral cross-linking device and method of use thereof

Abstract

The present invention discloses a posterior sclera cross-linking device and a method for using the same, wherein the posterior sclera cross-linking device comprises an air bag, including a contracted state and an expanded state after inflation; a connecting tube, one end of which is connected to the air bag for providing gas to the air bag; an optical fiber, which is arranged along the connecting tube, and the output end of the optical fiber is arranged at the position of the air bag. The present invention has the advantages of easy operation and low damage.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a posterior sclera cross-linking device. Background Art

[0002] Existing literature reports that the myopia rate in the general population has reached over 30%. This rate is estimated at approximately 30% among elementary school students, 50% among middle school students, and 75% among university students. Among all myopic patients, 1% to 2% suffer from pathological myopia. In patients with pathological myopia, the axial length of the eye progressively increases. If uncontrolled, this can lead to further ocular fundus disease and further damage.

[0003] The main site of axial growth is the posterior pole of the sclera. Since the main structure of the sclera is the stroma, which contains a large number of collagen fibers, the cross-linking of collagen fibers can be made stronger through ultraviolet light and the photosensitizer riboflavin, thereby increasing the biomechanical strength of the sclera. Therefore, the posterior sclera cross-linking technology is to increase the hardness of the posterior pole of the sclera to control axial growth and prevent the progression of myopia. Among them, the above-mentioned cross-linking technology has been maturely applied in the treatment of keratoconus, but it is less used in the posterior sclera. The main reason is that it is very difficult to make the entire cross-linking process occur at the back of the eyeball.

[0004] To enable the entire cross-linking process to occur at the back of the eyeball and achieve cross-linking of the posterior sclera, Chinese document CN111265359A discloses a cross-linker and system for posterior scleral treatment. This system utilizes an annular housing, a plano-convex lens, and multiple independent channels connecting the annular housing. Drugs and ultraviolet light are guided into the annular housing through the multiple independent channels and then irradiated onto the posterior sclera through the plano-convex lens, achieving cross-linking. While this structure can achieve cross-linking of the posterior sclera, it requires a relatively large incision to insert the annular housing into the posterior sclera, resulting in significant damage. Summary of the Invention

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the defect of the prior art equipment for achieving posterior scleral cross-linking that requires a large wound when used, resulting in great damage, thereby providing a posterior scleral cross-linking device with less damage and a method of use thereof.

[0006] A posterior scleral cross-linking device comprising:

[0007] Airbag, including deflated state and expanded state after inflation;

[0008] A connecting tube, one end of which is connected to the air bag and is used to supply gas to the air bag;

[0009] The optical fiber is arranged along the connecting tube, and the output end of the optical fiber is arranged at the position of the air bag.

[0010] The other end of the communicating pipe is connected to an air pump.

[0011] The input end of the optical fiber is connected to a solid ultraviolet laser.

[0012] The airbag has a groove when in an expanded state; the output end of the optical fiber is located at the groove.

[0013] The groove is hemispherical in shape and has a diameter of 5-15 mm.

[0014] The material of the airbag is a flexible implantable material.

[0015] A drug delivery tube is also arranged along the connecting tube, and a drug outlet of the drug delivery tube is arranged at the position of the air bag.

[0016] The medicine delivery tube, optical fiber and connecting tube are an integrated structure.

[0017] A method for cross-linking a posterior sclera cross-linking device comprises: extending an air bag into the posterior sclera, ventilating the air bag through a connecting tube to change it into an expanded state to fix the output end of an optical fiber, and inputting ultraviolet light into the posterior sclera through the optical fiber to achieve cross-linking of riboflavin at the posterior sclera.

[0018] The riboflavin at the posterior sclera is infiltrated into the posterior sclera by instillation, or / and is delivered into the groove at the airbag through a drug delivery tube during ultraviolet irradiation;

[0019] Preferably, the wavelength of the ultraviolet light is 370 nm and the irradiation intensity is 3 mW / cm 2 , the ultraviolet irradiation time is 30min.

[0020] The technical solution of the present invention has the following advantages:

[0021] 1. The present invention provides a posterior sclera cross-linking device, comprising an airbag, a connecting tube and an optical fiber. The combination of the airbag and the optical fiber can achieve cross-linking at the posterior sclera with a smaller wound and less damage. Specifically, the present invention can effectively place the airbag in the treatment area in a contracted state, and then ventilate it to become an expanded state. This method can effectively reduce the size of the wound required when the airbag is inserted into the posterior sclera. When the airbag is in the expanded state, it can fit tightly to the eyeball treatment area. At this time, ultraviolet light is introduced into the airbag position through the optical fiber. Since the end of the optical fiber can form a spherical point light source, the output end of the optical fiber is very close to the eyeball. Adjusting to a suitable light power is sufficient to cure the cross-linked drug, thereby achieving cross-linking of the drug riboflavin at the eyeball treatment area. After the cross-linking is completed, the gas in the airbag can be released to achieve the contraction of the airbag, thereby facilitating the removal of the entire device and completing the cross-linking operation. Therefore, the device of the present invention can increase the hardness of the posterior pole of the sclera, thereby controlling the growth of the eye axis and preventing myopia.

[0022] Moreover, the airbag used in the present invention is made of a flexible material, and will not damage the eyeball or intraocular tissue when it is inserted into the posterior sclera or removed in a contracted state, or when it is in an expanded state. Moreover, by cooperating with a flexible optical fiber, the insertion angle and position of the connecting tube can be adjusted more conveniently, thereby achieving fixation of the airbag at different positions on the posterior sclera, and further achieving cross-linking of multiple small areas on the posterior sclera. Compared with cross-linking of a large area, this can reduce the impact on the vascular tissue on the posterior sclera, avoid affecting the growth of capillaries on the sclera, and have a more significant effect.

[0023] 2. The present invention provides a posterior sclera cross-linking device, in which the airbag has a groove when inflated. When used, the groove of the airbag is positioned toward the posterior sclera, so that the airbag and the eyeball are tightly attached to form a closed space, which facilitates the cross-linking process. In addition, when a drug delivery tube is integrated with the connecting tube, the groove on the airbag can also accommodate excess riboflavin delivered to the posterior sclera through the drug delivery tube, preventing the drug from flowing everywhere and improving the cross-linking effect.

[0024] 3. The airbag in the posterior scleral cross-linking device provided by the present invention is preferably made of a flexible implantable material. The selection of this material can better avoid damage to the eyeball and surrounding tissues by the material itself during operation, and is safer. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0026] Figure 1 Schematic diagram of the structure of the device in the first embodiment of the present invention;

[0027] Figure 2 Schematic diagram of the cross-sectional structure of the airbag of the present invention;

[0028] Description of reference numerals:

[0029] 1-air bag, 2-connecting tube, 3-optical fiber, 4-air pump, 5-solid-state ultraviolet laser, 6-drug delivery tube. DETAILED DESCRIPTION

[0030] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0031] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limiting the present invention.

[0032] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0033] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0034] Example

[0035] A posterior scleral cross-linking device comprises: an airbag 1, a connecting tube 2, and an optical fiber 3. The airbag 1 comprises a contracted state and an expanded state after inflation; one end of the connecting tube 2 is connected to the airbag 1 for supplying gas to the airbag 1; the optical fiber 3 is arranged along the connecting tube 2, and the output end of the optical fiber 3 is arranged at the position of the airbag 1, such as Figure 1 shown.

[0036] The present invention provides a posterior sclera cross-linking device, comprising an airbag, a connecting tube and an optical fiber. The combination of the airbag and the optical fiber can achieve cross-linking at the posterior sclera with a smaller wound and less damage. Specifically, the present invention can effectively place the airbag in the treatment area in a contracted state, and then ventilate it to become an expanded state. This method can effectively reduce the size of the wound required when the airbag is extended into the posterior sclera. When the airbag is in the expanded state, it can fit tightly to the eyeball treatment area. At this time, ultraviolet light is introduced into the airbag position through the optical fiber. Since the end of the optical fiber can form a spherical point light source, the output end of the optical fiber is very close to the eyeball. Adjusting to a suitable light power is sufficient to cure the cross-linked drug, thereby achieving cross-linking of the drug riboflavin at the eyeball treatment area. After the cross-linking is completed, the gas in the airbag can be released to achieve the contraction of the airbag, thereby facilitating the removal of the entire device and completing the cross-linking operation. Therefore, the device of the present invention can increase the hardness of the posterior pole of the sclera, thereby controlling the growth of the eye axis and preventing myopia.

[0037] Moreover, the airbag used in the present invention is made of a flexible material, and will not damage the eyeball or intraocular tissue when it is inserted into the posterior sclera or removed in a contracted state, or when it is in an expanded state. Moreover, by cooperating with a flexible optical fiber, the insertion angle and position of the connecting tube can be adjusted more conveniently, thereby achieving fixation of the airbag at different positions on the posterior sclera, and further achieving cross-linking of multiple small areas on the posterior sclera. Compared with cross-linking of a large area, this can reduce the impact on the vascular tissue on the posterior sclera, avoid affecting the growth of capillaries on the sclera, and have a more significant effect.

[0038] In the present invention, an external gas pump 4 and a solid ultraviolet laser 5 can be added to provide gas and ultraviolet light for the device of the present invention, or the gas pump 4 and / or the solid ultraviolet laser 5 can be directly integrated into the device of the present invention. Specifically, when the external gas pump 4 and the solid ultraviolet laser 5 are used, it is only necessary to set a connection interface that can be connected to the external gas pump 4 at the other end of the connecting tube 2, and set a connector for connecting to the external solid ultraviolet laser 5 to realize ultraviolet light transmission at the input end of the optical fiber 3. When the gas pump 4 or the solid ultraviolet laser 5 is directly integrated, the gas pump 4 can be directly connected to the other end of the connecting tube 2, and then a connector can be set at the input end of the optical fiber 3; alternatively, a connection interface can be directly set at the other end of the connecting tube 2, and then the input end of the optical fiber 3 can be directly connected to the solid ultraviolet laser 5. When the air pump 4 and the solid ultraviolet laser 5 are directly integrated, the air pump 4 and the solid ultraviolet laser 5 can be integrated into one, and then the input end of the optical fiber 3 is connected to the solid ultraviolet laser 5, and the other end of the connecting tube 2 is connected to the air pump 4.

[0039] The solid-state ultraviolet laser 5 capable of achieving the function in the present invention includes, but is not limited to, a 365nm ultraviolet light source. This ultraviolet light source can be homemade or commercially available. It only needs to be able to emit 365nm ultraviolet light. The ultraviolet light source 5 and the optical fiber 3 are then connected in a conventional manner. Furthermore, since the airbag 1 is relatively small and requires a relatively small amount of gas, a micro-air pump is preferably used in the present invention to achieve inflation and deflation, such as a DC5-24V medical oxygen pump, which is even more compact.

[0040] In order to facilitate storage and organization, the optical fiber 3 and the connecting tube 2 in the present invention are composited into an integral structure along the axis of the connecting tube 2. The composite method can be adhesive bonding or wrapping it into one with a shell. The shell is preferably made of a flexible material, such as Nusil silicone. Figure 2 shown.

[0041] The balloon 1 connected to one end of the connecting tube 2 in the present invention can have a variety of shapes in its expanded state, as long as it can be fixed at the posterior sclera in the expanded state and ensure that the output end of the optical fiber 3 can irradiate the posterior sclera area that needs to be cross-linked after fixation. In the present invention, the balloon 1 in the expanded state preferably has a hemispherical shape with a diameter of 5-15 mm, preferably 10 mm. Figure 2 shown.

[0042] Furthermore, in order to better ensure that the output end of the optical fiber 3 can irradiate the posterior sclera part that needs to be cross-linked and to prevent the liquid from flowing freely during the irradiation process, the airbag 1 is provided with a groove when in the expanded state, and the output end of the optical fiber 3 is located at the groove position, such as Figure 2 shown.

[0043] In order to replenish the liquid medicine more timely and achieve a better cross-linking effect at the posterior sclera, a drug delivery tube 6 is integrated on the connecting tube 2. The drug delivery tube 6 can pump the liquid medicine into the groove through a drug pump, that is, the drug outlet of the drug delivery tube 6 is set in the groove on the airbag 1. The drug delivery tube 6 can be combined with the connecting tube 2 into an integrated structure, such as Figure 2 shown.

[0044] To minimize the effects of the material on the eyeball and surrounding tissues during operation, the airbag 1 is constructed of a flexible, implantable material. Furthermore, the outer shell surrounding the output end of the optical fiber 3 and the outlet of the connecting tube 2 and drug delivery tube 6 is also constructed of a flexible, implantable material, effectively enhancing safety during operation.

[0045] The specific method for achieving posterior scleral cross-linking using the posterior scleral cross-linking device of the present invention is as follows: Prior to use, ensure that the connecting tube 2 is connected to the air pump 4, the optical fiber 3 is connected to the solid-state ultraviolet laser 5, and the drug delivery tube 6 is connected to the drug liquid pump. Simultaneously, 30 minutes before using the device of the present invention, drip one drop of 0.1% low-molecular-weight dextran riboflavin into the patient's eye every two minutes to allow it to fully penetrate the sclera. Then, with the airbag 1 in a deflated state, the airbag 1 is introduced from the temporal side of the eyeball through the biocavity to the posterior portion of the eyeball. When it reaches the posterior pole of the sclera near the optic nerve, air is ventilated through the connecting tube 2, causing the airbag 1 to expand and secure the output end of the optical fiber 3. Ultraviolet light is then input through the optical fiber 3 to the posterior sclera to achieve cross-linking of the riboflavin at the posterior sclera. The wavelength of the ultraviolet light is set to 370 nm and the irradiation intensity is 3 mW / cm 2 The ultraviolet irradiation time is 30 minutes. During the cross-linking process, riboflavin can also be provided to the posterior sclera via the drug delivery tube 6. Specifically, one drop of the aforementioned 0.1% low-molecular-weight dextran riboflavin can be dripped through the drug delivery tube 6 every two minutes. Finally, physiological saline can be injected through the drug delivery tube 6 to clean the hemispherical area. To achieve multi-point cross-linking of a small area, after the cross-linking irradiation of this area is completed, the gas in the airbag 1 can be discharged through the connecting tube 2, changing the expanded state to the contracted state. The airbag 1 can then be moved to the appropriate position by bending the angle between the connecting tube 2 and the connecting tube 2 and the depth of the airbag 1 inserted into the eyeball. The above-mentioned steps of inflation, ultraviolet irradiation, and drug delivery can be repeated.

[0046] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A posterior scleral cross-linking device, characterized in that: include: An airbag (1), including a deflated state and an expanded state after inflation; A connecting pipe (2), one end of which is connected to the airbag (1) and is used to supply gas to the airbag (1); An optical fiber (3) is arranged along the connecting tube (2), and an output end of the optical fiber (3) is arranged at the position of the airbag (1); Wherein, the airbag (1) has a groove when in an expanded state; the output end of the optical fiber (3) is located at the position of the groove, and the end of the optical fiber forms a spherical point light source.

2. A posterior scleral cross-linking device according to claim 1, characterized in that: The other end of the connecting pipe (2) is connected to an air pump (4).

3. A posterior scleral cross-linking device according to claim 1 or 2, characterized in that: The input end of the optical fiber (3) is connected to a solid ultraviolet laser (5).

4. A posterior scleral cross-linking device according to claim 1, characterized in that: The groove is hemispherical in shape and has a diameter of 5-15 mm.

5. The posterior sclera cross-linking device according to claim 1, characterized in that: The material of the airbag (1) is a flexible implantable material.

6. A posterior sclera cross-linking device according to any one of claim 1, characterized in that: A drug delivery tube (6) is also arranged along the connecting tube (2), and a drug outlet of the drug delivery tube (6) is arranged at the position of the air bag (1).

7. A posterior scleral cross-linking device according to claim 6, characterized in that: The drug delivery tube (6), the optical fiber (3) and the connecting tube (2) are an integrated structure.

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