CN112807149A

CN112807149A - Posterior scleral crosslinking device and use method thereof

Info

Publication number: CN112807149A
Application number: CN202110145200.6A
Authority: CN
Inventors: 王乐今; 曹宇; 王顺平
Original assignee: Chaomu Technology Beijing Co ltd
Current assignee: Chaomu Technology Beijing Co ltd
Priority date: 2021-02-02
Filing date: 2021-02-02
Publication date: 2021-05-18

Abstract

The invention discloses a posterior sclera crosslinking device and a using method thereof, wherein the posterior sclera crosslinking device comprises an air bag, a back cushion and a back cushion, wherein the air bag comprises a contraction state and an inflated expansion state; one end of the communicating pipe is communicated with the air bag and is used for providing gas for the air bag; and the optical fiber is arranged along the communicating pipe, and the output end of the optical fiber is arranged at the position of the air bag. The invention has the advantages of convenient operation, small damage and the like.

Description

Posterior scleral crosslinking device and use method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a posterior sclera crosslinking device.

Background

The prior literature reports that the myopia rate of the general population reaches more than 30 percent; among them, the rate of myopia among pupils is about 30%, that of middle school students is about 50%, and that of college students is about 75%. Of all myopic patients, 1-2% are pathologic myopic. In patients with pathological myopia, the axis of the eye can grow progressively, and if not controlled, can further cause ocular fundus disease and produce greater damage.

The main part of the ocular axis growth is in the posterior pole of the sclera, and the main structure of the sclera is a matrix layer which contains a large amount of collagen fibers; the crosslinking of collagen fibers can be firmer through the crosslinking effect of ultraviolet rays and the photosensitizer riboflavin, so that the biomechanical strength of the sclera is enhanced. Therefore, posterior scleral crosslinking techniques increase the hardness of the posterior pole of the sclera to control the growth of the axis of the eye and prevent the progression of myopia. Of these, the cross-linking techniques described above have been well established for use in the treatment of keratoconus, but have been used less frequently in the posterior sclera, primarily because it is difficult to have the entire cross-linking process occur in the posterior segment of the eye.

In order to make the whole cross-linking process occur at the back of the eyeball to realize the cross-linking of the posterior sclera, chinese document CN111265359A discloses a cross-linking device and a cross-linking system for the treatment of the posterior sclera, wherein the system adopts an annular shell, a plano-convex lens and a plurality of independent channels connecting the annular shell, drugs and ultraviolet light are guided into the annular shell through the plurality of independent channels, and the drugs and ultraviolet light are irradiated at the back sclera part through the plano-convex lens to realize the cross-linking. Although the structure can realize the cross-linking of the posterior sclera, the annular shell can be extended into the posterior sclera part only by a larger wound, and the injury is larger.

Disclosure of Invention

Therefore, the technical problem to be solved by the present invention is to overcome the defect that the prior art devices for achieving posterior scleral crosslinking require a large wound to cause great trauma when in use, and thereby provide a posterior scleral crosslinking device with small trauma and a use method thereof.

A posterior scleral crosslinking device, comprising:

an airbag including a deflated state and an inflated, inflated state;

one end of the communicating pipe is communicated with the air bag and is used for providing gas for the air bag;

and the optical fiber is arranged along the communicating pipe, and the output end of the optical fiber is arranged at the position of the air bag.

The other end of the communicating pipe is communicated with an air pump.

And the input end of the optical fiber is connected with a solid ultraviolet laser.

The balloon having a groove in an inflated state; the output end of the optical fiber is positioned at the groove position.

The groove is hemispherical and has a diameter of 5-15 mm.

The balloon is made of a flexible implantable material.

A medicine conveying pipe is further arranged along the communicating pipe, and a medicine outlet of the medicine conveying pipe is arranged at the position of the air bag.

The medicine conveying pipe, the optical fiber and the communicating pipe are of an integrated structure.

A method of cross-linking a posterior scleral cross-linking device, comprising: the air bag is stretched into the position of the back sclera, the air bag is ventilated through the communicating pipe, the air bag is changed into an expansion state to realize the fixation of the output end of the optical fiber, and the riboflavin at the position of the back sclera can be crosslinked by inputting ultraviolet light to the position of the back sclera through the optical fiber.

The riboflavin at the position of the posterior sclera permeates into the position of the posterior sclera in a drip mode or/and is input into the groove at the position of the air bag through the drug delivery pipe in the ultraviolet irradiation process;

preferably, the wavelength of the ultraviolet light is 370nm, and the irradiation intensity is 3mW/cm²The ultraviolet irradiation time was 30 min.

The technical scheme of the invention has the following advantages:

1. the posterior sclera crosslinking device provided by the invention comprises the air bag, the communicating pipe and the optical fiber, and the matching of the air bag and the optical fiber can realize the crosslinking at the posterior sclera position under a smaller wound, so that the damage is smaller. Specifically, the invention can effectively realize that the air bag is placed at the treatment part in a contraction state and then is ventilated to change the air bag into an expansion state, the mode can effectively reduce the size of a wound required when the air bag extends into a posterior sclera part, and the air bag can be tightly attached to the eyeball treatment part in the expansion state; therefore, the device of the present invention can achieve increased hardness of the posterior pole of the sclera to control the growth of the axis of the eye and prevent myopia;

moreover, the air bag adopted in the invention is made of flexible material, and can not hurt the eyeball and the intraocular tissue when the air bag is extended into the posterior sclera part or taken out in a contraction state or in an expansion state; and through the cooperation with flexible optic fibre, can also adjust the angle of stretching into and the position of communicating pipe more conveniently, realize the gasbag in the fixed of different positions on back sclera position, and then realize the cross-linking of the little area of multiple spot on the back sclera, compare the cross-linking of large tracts of land, can reduce the influence to vascular tissue on the back sclera, avoid influencing the growth of capillary on the sclera, the effect is showing more.

2. According to the posterior sclera crosslinking device provided by the invention, the air bag is provided with the groove in the expansion state, and when the posterior sclera crosslinking device is used again, the groove part of the air bag is arranged towards the posterior sclera, so that the air bag is closely attached to the eyeball to form a closed space, and the operation of the crosslinking process is facilitated; in addition, when the medicine conveying pipe is integrated on the communicating pipe, the arrangement of the groove on the air bag can also accommodate the redundant medicine riboflavin conveyed to the posterior sclera part through the medicine conveying pipe, so that the medicine is prevented from flowing everywhere, and the crosslinking effect is improved.

3. The air bag in the posterior sclera crosslinking device provided by the invention is preferably made of a flexible implantable material, the material is selected in the operation process, the damage of the material to the eyeball and the peripheral tissues can be better avoided, and the safety is higher.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic structural diagram of an apparatus according to a first embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of the bladder of the present invention at the location;

description of reference numerals:

1-air bag, 2-communicating pipe, 3-optical fiber, 4-air pump, 5-solid ultraviolet laser and 6-medicine conveying pipe.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

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

Examples

A posterior scleral crosslinking device, comprising: balloon 1, communication tube 2, and optical fiber 3. Wherein, the air bag 1 comprises a contraction state and an expansion state after inflation; one end of the communicating pipe 2 is communicated with the air bag 1 and is used for providing gas for the air bag 1; an optical fiber 3 is disposed along communication pipe 2, and an output end of optical fiber 3 is disposed at the position of balloon 1, as shown in fig. 1.

The posterior sclera crosslinking device provided by the invention comprises the air bag, the communicating pipe and the optical fiber, and the matching of the air bag and the optical fiber can realize the crosslinking at the posterior sclera position under a smaller wound, so that the damage is smaller. Specifically, the invention can effectively realize that the air bag is placed at the treatment part in a contraction state and then is ventilated to change the air bag into an expansion state, the mode can effectively reduce the size of a wound required when the air bag extends into a posterior sclera part, and the air bag can be tightly attached to the eyeball treatment part in the expansion state; therefore, the device of the present invention can achieve increased hardness of the posterior pole of the sclera to control the growth of the axis of the eye and prevent myopia;

In the invention, an air pump 4 and a solid ultraviolet laser 5 can be additionally arranged to provide air and ultraviolet light for the device, and the air pump 4 or/and the solid ultraviolet laser 5 can be directly integrated on the device. Specifically, when the mode of the additional air pump 4 and the solid ultraviolet laser 5 is adopted, only the other end of the communicating pipe 2 needs to be provided with the communicating interface which can be communicated with the additional air pump 4, and the input end of the optical fiber 3 is provided with the connector which is used for being connected with the additional solid ultraviolet laser 5 to realize ultraviolet light transmission. When the mode of directly integrating the air pump 4 or the solid ultraviolet laser 5 is adopted, the air pump 4 can be directly communicated with the other end of the communicating pipe 2, and then a connector is arranged at the input end of the optical fiber 3; or, the other end of the communication pipe 2 may be directly provided with a communication interface, and then the other end of the communication pipe is directly connected to the solid ultraviolet laser 5 at the input end of the optical fiber 3. When adopting the equal direct integrated mode of air pump 4 and solid ultraviolet laser 5, can be integrated as an organic whole with air pump 4 and solid ultraviolet laser 5, then connect the input of optic fibre 3 on solid ultraviolet laser 5, simultaneously with the other end and the air pump 4 intercommunication of communicating pipe 2 can.

The solid ultraviolet laser 5 capable of realizing the functions comprises but is not limited to a 365nm ultraviolet light source, the ultraviolet light source can be self-made or purchased, only 365nm ultraviolet light needs to be emitted, and then the ultraviolet light source 5 and the optical fiber 3 are communicated in a conventional mode. Meanwhile, for the air bag 1, because the air bag 1 itself is small, and the required air volume is also small, the micro air pump can achieve the inflation and deflation effects, such as: the DC5-24V medical oxygenation air pump is smaller and more compact in size.

In order to facilitate storage and arrangement, the optical fiber 3 and the communication pipe 2 are compounded into an integral structure along the axis of the communication pipe 2, the compound mode can adopt bonding, and can also adopt a shell to wrap the integral structure, and the shell is preferably made of flexible materials, such as Nusil silica gel; as shown in fig. 2.

The shape of the air bag 1 communicated with one end of the communicating pipe 2 in the expansion state can be set to be various, as long as the expansion state can be fixed at the position of the posterior sclera, and the output end of the optical fiber 3 can be ensured to be irradiated to the position of the posterior sclera needing to be crosslinked after the fixation. The balloon 1 of the present invention is preferably hemispherical in shape in its inflated state and has a diameter of 5-15mm, preferably 10mm, as shown in fig. 2.

Further, in order to better ensure that the output end of the optical fiber 3 can irradiate the posterior sclera part needing to be crosslinked and simultaneously avoid the random flow of the liquid medicine in the irradiation process, the airbag 1 is also provided with a groove in the expansion state, and the output end of the optical fiber 3 is positioned at the position of the groove, as shown in fig. 2.

In order to supplement the liquid medicine more timely and enable the liquid medicine to achieve a better cross-linking effect at the back sclera part, the communicating pipe 2 is further integrated with a medicine conveying pipe 6, the medicine conveying pipe 6 can pump the liquid medicine into the groove through a medicine liquid pump, namely, a medicine outlet of the medicine conveying pipe 6 is arranged in the groove on the air bag 1. The medicine conveying pipe 6 and the communicating pipe 2 can be compounded into an integral structure as shown in figure 2.

In order to avoid the influence of the material on the eyeball and the tissues around the eyeball during operation, the material of the air bag 1 is flexible implantable material. Meanwhile, the shell which wraps the output end of the optical fiber 3 and one side of the medicine outlet of the communicating pipe 2 and the medicine conveying pipe 6 is also made of flexible implantable materials, so that the safety during operation is effectively improved.

The specific application method for realizing posterior scleral crosslinking by adopting the posterior scleral crosslinking device comprises the following steps: before use, the communicating pipe 2 is firstly ensured to be communicated with the air pump 4, the optical fiber 3 is communicated with the solid ultraviolet laser 5, and the medicine conveying pipe 6 is communicated with the medicine liquid pump; meanwhile, 1 drop of low molecular weight dextran riboflavin with mass concentration of 0.1% is dropped into eyes of a patient every 2min 30min before the device is used, so that the low molecular weight dextran riboflavin is fully infiltrated into scleral tissues. Then, when the air bag 1 is in a contraction state, the air bag 1 enters the back part of the eyeball from the temporal side of the eyeball through a biological cavity, when the air bag reaches the back pole part of the sclera near the optic nerve, the air bag 1 is ventilated through the communicating pipe 2, the air bag 1 is changed into an expansion state to realize the fixation of the output end of the optical fiber 3, the ultraviolet light is input to the position of the back sclera through the optical fiber 3 to realize the cross-linking of the riboflavin at the position of the back sclera, the setting wavelength of the ultraviolet light is 370nm, and the irradiation intensity is 3mW/cm²The ultraviolet irradiation time was 30 min. In the cross-linking process, the medicine liquid riboflavin can be provided for the position of the posterior sclera through the medicine delivery pipe 6, and specifically, 1 drop of the medicine liquid riboflavin with the mass concentration of0.1% low molecular weight glucan riboflavin; finally, the hemispherical area can be cleaned by inputting physiological saline through the drug delivery pipe 6. In order to realize multipoint small-area crosslinking, after the irradiation of the crosslinking at the part is finished, the gas in the air bag 1 is discharged through the communicating pipe 2, the expansion state is changed into the contraction state, then the air bag is moved to the adaptive position through bending the angle between the air bag 1 and the communicating pipe 2 and the depth of the air bag 1 extending into the eyeball part, and the steps of inflation, ultraviolet irradiation and liquid medicine input are repeated.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. A posterior scleral crosslinking device, comprising:

an airbag (1) comprising a contracted state and an inflated expanded state;

one end of the communicating pipe (2) is communicated with the air bag (1) and is used for providing air for the air bag (1);

and the optical fiber (3) is arranged along the communicating pipe (2), and the output end of the optical fiber (3) is arranged at the position of the air bag (1).

2. The posterior scleral crosslinking device according to claim 1, wherein an air pump (4) is connected to the other end of the communication tube (2).

3. A posterior scleral crosslinking device according to claim 1 or 2, wherein a solid-state uv laser (5) is connected to the input end of the optical fiber (3).

4. A posterior scleral crosslinking device according to any one of claims 1 to 3, wherein the balloon (1) has a recess in the inflated state; the output end of the optical fiber (3) is positioned at the groove position.

5. The posterior scleral crosslinking device of claim 4, wherein the indentation is hemispherical in shape and has a diameter of 5-15 mm.

6. A posterior scleral crosslinking device according to claim 4, wherein the balloon (1) is made of a flexible implantable material.

7. A posterior scleral crosslinking device according to any one of claims 1 to 6, wherein a drug delivery tube (6) is further provided along the communicating tube (2), and the drug outlet of the drug delivery tube (6) is provided at the balloon (1).

8. The posterior scleral crosslinking device of claim 7, wherein the drug delivery tube (6), the optical fiber (3) and the communication tube (2) are of a unitary structure.

9. A method of using a posterior scleral crosslinking device according to any one of claims 1 to 8, comprising: the air bag (1) is stretched into the position of the posterior sclera, the air bag (1) is ventilated through the communicating pipe (2), the air bag is changed into an expansion state to realize the fixation of the output end of the optical fiber (3), and the cross-linking of the riboflavin at the position of the posterior sclera can be realized by inputting ultraviolet light to the position of the posterior sclera through the optical fiber (3).

10. Use according to claim 9, wherein the riboflavin at the posterior scleral site is incorporated by instillation into the posterior scleral site or/and is delivered via the delivery tube (6) into the recess at the balloon (1) site during the uv light irradiation;