CN114848288B

CN114848288B - Posterior sclera minimally invasive crosslinking system

Info

Publication number: CN114848288B
Application number: CN202210478977.9A
Authority: CN
Inventors: 尚瑞宁; 李晓娜; 陈维毅
Original assignee: Taiyuan University of Technology
Current assignee: Taiyuan University of Technology
Priority date: 2022-05-05
Filing date: 2022-05-05
Publication date: 2025-09-09
Anticipated expiration: 2042-05-05
Also published as: CN114848288A

Abstract

The present invention relates to the field of medical device technology, specifically a posterior scleral minimally invasive cross-linking system. The system solves the current problem of lacking a scleral surgical instrument that can reduce the trauma of scleral surgery and prevent the spread of progressive myopia. The system includes a light source system, a liquid guide system, a telescopic system, a negative pressure system, a control system, and a positioning system. The light source system includes an ultraviolet array/blue light array light source or an ultraviolet/blue light electroluminescent material; the liquid guide system includes a liquid guide pump and a capillary controlled by a single-chip microcomputer to introduce liquid and a capillary for treating waste liquid; the telescopic system is controlled by a single-chip microcomputer to control a telescopic rod to achieve minimally invasive surgery; the negative pressure system is a ring tube and a three-way tube made of flexible material, which is used to draw vacuum to form a negative pressure state to prevent the leakage of reactants; the positioning system places an endoscope on the top layer of the membrane to achieve the positioning function of the minimally invasive instrument. The present invention has good flexibility, high degree of automation and safety, and can achieve minimally invasive operation when performing posterior scleral cross-linking method.

Description

Posterior sclera minimally invasive crosslinking system

Technical Field

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

Background

High myopia is caused by axial overextension of the eye, and so this involves the outer layer of the eyeball, the sclera. The sclera protects the intraocular structures, determines the final shape and size of the eye, and is the anchor for the extraocular muscles and provides support for the ciliary muscles, which in turn function to assist in accommodating the lens. Thus, studying the sclera is a primary goal in mitigating the therapeutic manipulation of progressive myopia. Presently, reinforced scleral surgery is the only option available clinically to slow down scleral spur, however this surgery is associated with a risk of complications and is not ideal. It is desirable to develop a posterior scleral minimally invasive cross-linking system that reduces the trauma of the posterior scleral reinforcement procedure, while effectively preventing the progression of progressive myopia.

Disclosure of Invention

The invention provides a posterior scleral minimally invasive crosslinking system, which aims to solve the technical problem that a scleral surgical instrument capable of reducing scleral surgical trauma and preventing progressive myopia from spreading is lacking at present.

The invention adopts the following technical scheme that the posterior sclera minimally invasive crosslinking system comprises a light source system, a liquid guide system, a telescopic system, a negative pressure system, a control system and a positioning system, wherein the negative pressure system comprises a body with an opening at the bottom, a negative pressure ring, an air suction connecting clamp and an air guide pump, the negative pressure ring is arranged around the inner side edge of the body, the telescopic system is positioned inside the body and connected with the front inner wall and the rear inner wall of the body, the cross section of the negative pressure ring is in an n shape, the negative pressure ring is annular but two ports are not connected, two body outlets are respectively arranged on the front side of the body, the two ports of the negative pressure ring are respectively led out from the two outlets, the air suction connecting clamp is a three-way pipe and respectively connected with the two ports of the negative pressure ring and the air guide pump, the telescopic system is provided with a hole in the middle, the light source system is arranged at the top of the body and is opposite to the hole in the middle of the telescopic system, the liquid guide system comprises a liquid inlet pipe, a liquid outlet pipe and a liquid guide pump which can be connected with the liquid inlet pipe and the liquid outlet pipe, the liquid inlet pipe and the liquid outlet pipe extend into the body from the outside respectively, the body, the negative pressure pipe and the liquid inlet pipe and the liquid guide pump are respectively, the liquid guide system and the integrated system are positioned on the light source system and the light source system.

The telescopic system can realize the telescopic of the body structure so as to realize minimally invasive surgery, the telescopic system is extended to enable the body to be in a slender state, the positioning system is used for positioning the whole system at the moment, the slender body is placed in a region to be crosslinked of a sclera, the telescopic system is contracted to restore the working state of the body, the air guide pump is opened to enable the negative pressure ring to be adsorbed on the sclera, the transfusion function of the liquid guide pump is opened, liquid is guided into the body through the liquid inlet pipe and is contacted with the crosslinking region, the light source system is opened to carry out irradiation crosslinking, after the crosslinking is finished, the light source is closed, the liquid guide pump is opened, waste liquid is pumped out through the liquid outlet pipe, and the crosslinking is finished. And then the cleaning solution is led into the body through the liquid guide pump, and after the cleaning is finished, the liquid guide pump is turned on to pump out the waste liquid.

Furthermore, the light source system can be selected to be manufactured into a UVA/BLUE LED array, UVA is preferably 370nm purple light, BLUE is preferably 445nm BLUE light, or an organic electroluminescent material capable of emitting corresponding wavelengths is selected as a light source, and the positioning system is arranged at a gap of the LED array or the fluorescent film, so that the sclera can be conveniently observed and the positioning of the body can be realized.

Furthermore, the control system establishes a system model through programming design of the singlechip, so that numerical control is realized.

Furthermore, the negative pressure system adopts a ring pipe (with an n-shaped section) and a three-way pipe which are made of flexible materials to draw vacuum to form a negative pressure state so as to prevent the reactants from exuding.

Furthermore, the telescopic system adopts a telescopic rod to realize the telescopic of a mechanical structure by matching with a singlechip, thereby realizing minimally invasive surgery.

Furthermore, the positioning system adopts an implantation endoscope, and an image processing algorithm based on a neural network is adopted to realize accurate positioning at the posterior pole of the sclera.

Further, the negative pressure ring, the liquid guide system and the control system are integrated.

The specific size of the posterior scleral minimally invasive crosslinking system is about 10 x 7 x 5mm, and the size after the expansion transformation is about 5 x 14 x 5mm.

Based on the posterior sclera minimally invasive crosslinking system provided by the invention, a method for crosslinking by using the posterior sclera minimally invasive crosslinking system can be implemented, and photochemical crosslinking and chemical crosslinking can be performed.

And a chemical crosslinking part, namely, a formaldehyde slow-release preservative (FARs), glyceraldehyde, glutaraldehyde, nitroalcohols, genipin and other chemical crosslinking agents are generally selected and flow into a crosslinking area through a liquid guide pump, wherein the negative pressure ring is closely attached to sclera tissues through vacuum air suction to prevent the chemical crosslinking agents from flowing out, and after the reaction is finished, waste liquid is recovered through a capillary tube at the other side of the liquid guide pump.

The mechanism of CXL is that singlet oxygen is generated when riboflavin is irradiated by UVA/BLUE light. The singlet oxygen then oxidizes the collagen to form covalent crosslinks, which can be used as blue and violet crosslinks due to the fact that riboflavin has two second absorption peaks, about 445nm and 370nm, respectively. Firstly, the riboflavin flows into a crosslinking area through a liquid guide pump, wherein a negative pressure ring is closely attached to sclera tissues through vacuum air suction to prevent the riboflavin from flowing out, an LED array or an electroluminescent fluorescent material is electrified to generate photochemical crosslinking, after the reaction is finished, waste liquid is recovered through a capillary on the other side of the liquid guide pump, then a self-cleaning function is started, the crosslinking area is cleaned, and the residual liquid is diluted and LED out.

The invention has the advantages that:

1. The invention provides a posterior sclera minimally invasive crosslinking system which comprises a light source system, a liquid guide system (comprising a self-cleaning system), a telescopic system, a negative pressure system, a control system and a positioning system. The cross-linking at the position of the posterior sclera can be realized under a smaller wound by adopting the telescopic system, so that the damage is smaller. Specifically, the invention can effectively realize that the telescopic rod is placed in the crosslinking area in a contracted state, then the length of the telescopic rod is changed through an adjustment program, so that the surface layer structure of the crosslinking system is programmed, and the area crosslinking is realized. At this time, (1) chemical crosslinking may be directly performed, and after the completion of the crosslinking, the waste liquid may be discharged through a capillary (liquid outlet pipe) on the other side of the liquid-guiding pump. (2) Adjusting the proper light power to sufficiently solidify the crosslinking medicine through the LED array or the electroluminescent ultraviolet fluorescent material, so that photochemical crosslinking is realized at the eyeball treatment part, and after the crosslinking is finished, introducing gas into the negative pressure ring to relieve the negative pressure, thereby facilitating the whole taking out of the device and finishing the crosslinking operation; thus, the device of the present invention may achieve increased rigidity at the posterior pole of the sclera to control the growth of the eye's axis and prevent myopia.

2. The negative pressure ring adopted in the invention is a flexible material, and can not hurt eyeballs and intraocular tissues when being fixed at the posterior sclera part or taken out during negative pressure, and the telescopic transformation of the whole instrument is realized through the matching of the telescopic rod, so that the minimally invasive operation can be realized under the condition of not shearing the extraocular muscles.

3. The invention provides a posterior sclera minimally invasive crosslinking system, wherein a negative pressure ring is provided with a groove in a normal state, and when the posterior sclera minimally invasive crosslinking system is used, the groove part of the negative pressure ring is placed towards the tissue direction of the posterior sclera, and the negative pressure ring is changed into a negative pressure state by air suction, so that the negative pressure ring is closely attached to the sclera to form a closed space, thereby preventing a crosslinking reagent from flowing out and polluting other positions.

4. Uniform irradiation in the cross-linked region is achieved using an LED array or organic electro-mechanical uv/blue fluorescent material.

5. An ophthalmic endoscope system is placed in the system so that a positioning effect can be achieved.

Drawings

Fig. 1 is a schematic bottom view of a posterior scleral minimally invasive crosslinking system.

FIG. 2 is a schematic view of the structure of the air extraction connecting clamp.

Fig. 3 is a bird's eye view of a posterior scleral minimally invasive crosslinking system.

Figure 4 is a schematic cross-sectional view of a negative pressure system.

Fig. 5 is a B-B cross-sectional view of fig. 4.

Fig. 6 is a front view of the negative pressure system.

Fig. 7 is a transverse view of a posterior scleral minimally invasive cross-linking system.

Fig. 8 is a cross-sectional view A-A of fig. 7.

Fig. 9 is a front view of a posterior scleral minimally invasive crosslinking system.

Fig. 10 is a schematic of a minimally invasive posterior scleral minimally invasive cross-linking system.

Fig. 11 is a front axial view of the telescoping rod.

Fig. 12 is a schematic diagram of a front view of a telescopic rod.

Fig. 13 is a schematic perspective view of a telescopic rod.

Fig. 14 is a schematic bottom view of the telescopic rod.

Fig. 15 is a C-C cross-sectional view of fig. 14.

The LED lamp comprises a 1-LED array, a 2-telescopic rod, a 3-positioning system, a 4-body, a 5-negative pressure ring, a 6-air extraction connecting clamp, a 7-liquid inlet pipe, an 8-liquid outlet pipe, a 9-body outlet, a 10-liquid inlet pipe orifice and a 11-liquid outlet pipe orifice;

21-cylindrical section, 22-circular ring section, 23-spring.

Detailed Description

Example 1

A posterior sclera minimally invasive crosslinking system comprises a light source system, a liquid guide system, a telescopic system, a negative pressure system, a control system and a positioning system 3, wherein the negative pressure system comprises a body 4 with an opening at the bottom, a negative pressure ring 5, an air suction connecting clamp 6 and an air guide pump, the negative pressure ring 5 is arranged in the body 4 and connected with the front inner wall and the rear inner wall of the body 4, the cross section of the negative pressure ring 5 is in an n shape, the negative pressure ring 5 is enclosed into a ring shape but two ports are not connected, two body outlets are respectively formed in the front side of the body 4, the two ports of the negative pressure ring 5 are respectively led out from the two outlets, the air suction connecting clamp 6 is a three-way pipe, the two ports of the negative pressure ring 5 and the air guide pump are respectively connected, a hole is formed in the middle of the telescopic system, the light source system is arranged at the top of the body 4 and is opposite to the hole in the middle of the telescopic system, the liquid guide system comprises a liquid inlet pipe 7, a liquid outlet pipe 8 and a liquid guide pump capable of being connected with the liquid inlet pipe 7 and the liquid outlet pipe 8, the liquid inlet pipe 7 and the liquid outlet pipe 8 are respectively stretched out of the body 2, the two ports of the body 2 are respectively, the negative pressure ring 5 and the liquid guide system is respectively, the negative pressure connecting system is formed in the front of the body, the liquid guide system is positioned on the liquid guide system, and the light source system is positioned on the light source system 3, and the light source system is respectively.

Example 2

As shown in fig. 3, the body 4 is in a hollow small sphere table structure (or similar to a bowl shape or a cover) with a downward opening, a fixed ring is connected below the periphery of the small sphere table, the negative pressure ring 5 is mounted close to the inner wall of the fixed ring, a telescopic system is mounted on the front inner wall and the rear inner wall of the fixed ring, and the light source system is suspended at the inner top of the small sphere table through a bracket.

Example 3

The light source system adopts an ultraviolet/blue light LED array 1 or an ultraviolet/blue light fluorescent film made of organic electroluminescent materials, the wavelength of ultraviolet light is 370nm, the wavelength of blue light is 445nm, and the positioning system 3 is arranged at the gap of the LED array 1 or the fluorescent film. The telescopic system consists of two telescopic rods 2 which are spaced at a certain distance and are parallel to each other, and the light source system corresponds to the interval between the two telescopic rods 2.

Example 4

The port of the liquid inlet pipe 7 extending into the body is positioned at the high position in the body 4, the liquid outlet pipe 8 extends into the rear of the body 4 and is positioned at the low position in the body 4, and the side walls of the liquid inlet pipe and the liquid outlet pipe, which are positioned on the two outlets on the front side of the body 4, extend into the body. As shown in fig. 1, one nozzle of the liquid inlet pipe extends into the front side of the body, and one nozzle of the liquid outlet pipe is positioned at the rear of the body, so that the liquid in the liquid inlet pipe can be conveniently pumped out. When the peristaltic pump is used as a power source for the air guide pump and the liquid guide pump, the body 4, the negative pressure ring 5 and the liquid inlet/outlet pipe are made of flexible materials (polydimethylsiloxane (PDMS) and Polyurethane (PU)), and when the injection pump is used for the air guide pump and the liquid guide pump, the body 4, the negative pressure ring 5 and the liquid inlet/outlet pipe are made of hard pipe materials.

The control system adopts a singlechip, and the positioning system 3 is an endoscope. The light source system, the telescopic system and the positioning system 3 are led out from the inside of the body 4 through lead-out wires and are connected with a control system.

As shown in fig. 1, the posterior sclera minimally invasive crosslinking system comprises a light source system, a liquid guide system (comprising a self-cleaning system), a telescopic system, a negative pressure system, a control system and a positioning system. The invention has good flexibility, high automation degree and high safety, and can realize minimally invasive operation when a posterior scleral crosslinking method is carried out.

The light source system has the position distribution shown in figures 1, 7, 8 and 9, and comprises an LED array 1 of UVA/BLUE or an OLED fluorescent film made of organic electroluminescent materials.

The liquid guide system is characterized in that the position distribution of the liquid guide system is shown in figure 7, a liquid inlet pipe is arranged at 7 and is positioned at the high position of the device, the liquid can completely infiltrate the sclera due to the angle of the sclera after the system is implanted, a liquid outlet is arranged at 8 and is positioned at the low position of the device, and the reacted liquid medicine residues can flow out, and the self-cleaning system is used for replacing the liquid medicine with cleaning liquid.

The specific positions of the telescopic system are shown in fig. 7 and 8, the telescopic rod 2 can control the extension of the telescopic rod to adjust the size of the posterior sclera minimally invasive crosslinking system so as to realize minimally invasive, and the specific transformation process is shown in fig. 10. The specific size of the posterior scleral minimally invasive crosslinking system is about 10 x 7 x 5mm, and the size after the expansion transformation (elongation state) is about 5 x 14 x 5mm, namely, the posterior-anterior direction elongation.

As shown in fig. 11-15, the telescopic rod 2 is composed of a cylindrical section 21, a circular ring section 22 fixed at the front end of the cylindrical section 21 and a spring 23 nested in the circular ring section 22, wherein the front end of the spring 23 is fixedly connected with the front end inner wall of the circular ring section 22, the front end of the circular ring section 22 is connected with the front part of the inner wall of the body 4, the tail end of the cylindrical section 21 is connected with the rear part of the inner wall of the body 4, the circular ring section 22 is connected with an external pneumatic pump through an air duct extending into the body 4 from the outer wall of the body 4, the cylindrical section 21 of the telescopic rod 2 is made of a double-component PDMS material A (dimethyl silicone oil) and a double-component PDMS material B (curing agent) according to the mass ratio of 1:5 and 100 ℃, the circular ring section 22 of the telescopic section is made of the double-component PDMS material A (dimethyl silicone oil) and the double-component PDMS material B (curing agent) according to the mass ratio of 1:10 and 70 ℃, and the air injection pushes the circular ring section and the spring to deform through the pneumatic pump, so that the telescopic rod is directly deformed, and the telescopic function is realized.

The negative pressure system is connected with the air extraction connecting clamp shown in fig. 3 and is externally connected with the air guide pump, so that the negative pressure ring is in a vacuum state and is firmly attached to the sclera to control the liquid medicine not to be oozed, and the specific structure of the negative pressure system is shown in fig. 4,5 and 6.

The control system is formed by an external single chip microcomputer unit and is connected with an upper computer to realize accurate control.

The positioning system adopts an endoscope installed in the body, the endoscope feeds back imaging, and an ophthalmologist performs positioning operation to realize the positioning function of a minimally invasive instrument.

The method of use of the present invention in posterior scleral crosslinking (photochemically crosslinked portion) is as follows:

(1) Before use, the capillary tube is connected with the liquid guide pump controlled by the singlechip, the negative pressure ring is connected with the air guide pump, the LED array wire is connected with the singlechip, and the endoscope is fixed at the front end. The conjunctiva was cut, and subconjunctival tissue and tenn's sacs were isolated.

(2) After a clinician determines a scleral region of a patient most suitable for irradiation according to the position and the degree of a posterior scleral grape swelling of the fundus of the patient, the telescopic rod is in an elongated limit position by using a first form of the crosslinking system, and the whole crosslinking system is in an elongated state. The crosslinking system is inserted under the Tenon's bag by using forceps, the target area required to be irradiated by the LED array sclera is adjusted by using an endoscope at the front side of the crosslinking system, then the telescopic rod is retracted by a control system of a singlechip through inputting instructions by a computer, the whole crosslinking system is in a surface layer structure, and the crosslinking area is greatly enlarged.

(3) After the positioning is finished, the negative pressure ring is pumped to form negative pressure, and the negative pressure ring is fixed at the crosslinking part to prevent chemical reagents such as riboflavin from exuding.

(4) The single chip microcomputer system is utilized to control, the liquid guide system uniformly and continuously supplies the riboflavin solution at a fixed speed, the riboflavin solution is pushed into the main body part of the cross-linking device through the capillary, and finally 0.1% of the riboflavin solution is inserted into the Tenon's capsule through the capillary and is infiltrated into the posterior pole sclera for about 30 minutes, so that the riboflavin solution can continuously infiltrate into the targeted sclera area to prepare for the next sclera cross-linking.

(5) Irradiation of the crosslinked posterior scleral region with a uniform and single UVA/BLUE LED array or energizing the electro-UVA/BLUE fluorescent material produces a uniform single UVA/BLUE light irradiation of the crosslinked region. After the highly permeable riboflavin solution has fully infiltrated the cross-linked scleral region, the UVA/BLUE light from the LED array light source or the electro-UVA/BLUE fluorescence is irradiated to fully activate the riboflavin photosensitizer, thereby achieving the effect of cross-linking at the posterior pole of the sclera.

(6) After the crosslinking is finished, the leading-out function of the liquid guide pump is started, and the reacted waste liquid is led out through the capillary tube at the other side.

(7) After the waste liquid is led, the liquid medicine pipe is taken out and is replaced by the cleaning liquid pipe, the cleaning liquid is led in through a liquid guiding pump of the liquid guiding system, the waste liquid is soaked for a while, and then the waste liquid is led out through a leading-out function of the liquid guiding pump.

(8) Injecting gas at the negative pressure ring to separate from the negative pressure, taking out the cross-linking device, and suturing the conjunctival wound.

Claims

1. A posterior sclera minimally invasive crosslinking system is characterized by comprising a light source system, a liquid guide system, a telescopic system, a negative pressure system, a control system and a positioning system (3), wherein the negative pressure system comprises a body (4) with an opening at the bottom, a negative pressure ring (5), an air suction connecting clamp (6) and an air guide pump, the negative pressure ring (5) is arranged in the body (4) and is connected with the front inner wall and the rear inner wall of the body (4), the section of the negative pressure ring (5) is in an n shape, the negative pressure ring (5) is enclosed into a ring shape, two ports are not connected, two body outlets (9) are respectively formed in the front side of the body (4), the two ports of the negative pressure ring (5) are respectively led out from the two outlets, the air suction connecting clamp (6) is a three-way pipe, the two ports of the negative pressure ring (5) are respectively connected, a hole is formed in the middle of the telescopic system, the light source system is arranged at the inner top of the body (4) and is opposite to the hole in the middle of the telescopic system, the liquid guide system comprises a liquid inlet pipe (7) and a liquid outlet pipe (8) which can be respectively connected with the liquid inlet pipe (7) and the liquid outlet pipe (4) respectively, the positioning system (3) is integrated on the light source system, and the control system is connected with the light source system, the telescopic system, the positioning system (3), the air guide pump and the liquid guide pump.

2. The posterior sclera minimally invasive crosslinking system according to claim 1, wherein the body (4) is in a hollow sphere table structure with a downward opening, a fixing ring is connected below the circumference of the sphere table, the negative pressure ring (5) is mounted close to the inner wall of the fixing ring, the telescopic system is mounted on the front inner wall and the rear inner wall of the fixing ring, and the light source system is suspended at the inner top of the sphere table through a bracket.

3. A posterior scleral minimally invasive cross-linking system according to claim 1, characterized in that the light source system employs an LED array (1) of uv/blue light or a uv/blue light phosphor film made of organic electroluminescent material, and the positioning system (3) is mounted at the gap of the LED array (1) or phosphor film.

4. A posterior scleral minimally invasive cross-linking system according to claim 3 wherein the violet light has a wavelength of 370nm and the blue light has a wavelength of 445nm.

5. A posterior scleral minimally invasive cross-linking system as in claim 2, wherein said telescopic system consists of two telescopic rods (2) spaced apart and parallel to each other, the light source system corresponding to the spacing between the two telescopic rods (2).

6. The posterior scleral minimally invasive crosslinking system according to claim 5, wherein the telescopic rod (2) comprises a cylindrical section (21), a circular ring section (22) fixed at the front end of the cylindrical section (21) and a spring (23) nested in the circular ring section (22), wherein the front end of the spring (23) is fixedly connected with the inner wall of the front end of the circular ring section (22), the front end of the circular ring section (22) is connected with the front part of the inner wall of the body (4), the tail end of the cylindrical section (21) is connected with the rear part of the inner wall of the body (4), and the circular ring section (22) is connected with an external pneumatic pump through an air duct extending into the body (4) from the outer wall of the body (4).

7. The posterior sclera minimally invasive crosslinking system according to claim 6, wherein the cylindrical section (21) of the telescopic rod (2) is made of a two-component PDMS material A liquid and a two-component PDMS material B liquid by mass ratio of 1:5 and 100 ℃, and the annular section (22) is made of the two-component PDMS material A liquid and the two-component PDMS material B liquid by mass ratio of 1:10 and 70 ℃.

8. A posterior scleral minimally invasive cross-linking system according to any of claims 1-7, wherein the port of the inlet tube (7) extending into the body is located at a high level inside the body (4), the outlet tube (8) extending into the body (4) and then being located at a low level inside the body (4), the inlet/outlet tubes extending into the body (4) from the side walls of the body (4) above the two outlets on the front side of the body (4), respectively.

9. The posterior sclera minimally invasive crosslinking system according to any one of claims 1 to 7, wherein the control system is a single chip microcomputer, the positioning system (3) is an endoscope, and the light source system, the telescopic system and the positioning system (3) are led out from the inside of the body (4) through lead wires and are connected with the control system.

10. A posterior scleral minimally invasive cross-linking system according to any of claims 1-7, wherein the body (4), the negative pressure ring (5), and the inlet/outlet tube are made of flexible material when peristaltic pumps are used as the power source for the air-conducting pump and the liquid-conducting pump, and rigid tube material when syringe pumps are used for the liquid-conducting pump.