WO2019085362A1 - Self-expansion-fixing artificial nasolacrimal duct - Google Patents

Abstract

An artificial nasolacrimal duct capable of being fixed in place by self-expansion. The artificial nasolacrimal duct has a hollow tubular structure with an inner diameter of 0.5-1.5 mm and an outer diameter of 0.6-4.0 mm. The artificial nasolacrimal duct is made of a water-swellable material. The artificial nasolacrimal duct has a simple structure, does not require a structure whose end size is larger than the physiological size of the lacrimal passage to achieve the purpose of fixation, has good fixation effects, and does not easily fall off after expansion by absorbing water.

Description

Self-expanding fixed artificial nasolacrimal duct Technical field

The invention relates to an artificial nasolacrimal duct, in particular to a self-expanding fixed artificial nasolacrimal duct.

Background technique

It is a common eye disease, which is caused by the stenosis or obstruction of the nasolacrimal duct, which causes the tears to stay in the lacrimal sac. The long-term tearing of the patient has seriously affected the quality of life of the patient. Artificial nasolacrimal duct implantation is a minimally invasive treatment for this type of disease. The existing artificial nasolacrimal duct stent is mainly a hollow tube obtained from materials such as nickel-titanium metal, glass, medical silicone rubber and polyurethane. The biocompatibility of the material is relatively poor and cannot be permanently placed, usually after surgery. The stent was removed by a second operation in three months. This often causes secondary damage, leading to bleeding, inflammation and other reactions, and then granulation and other phenomena, leading to obstruction of the lacrimal duct. In addition, these stents are usually fixed by using the end size larger than the physiological size of the lacrimal passage, the fixation effect is poor, and the incidence of shedding is high.

Summary of the invention

It is an object of the present invention to provide a self-expanding fixed artificial nasolacrimal duct that overcomes the deficiencies of the prior art.

In order to achieve the above object, the technical solution adopted by the present invention is: a self-expanding fixed artificial nasolacrimal duct, wherein the artificial nasolacrimal duct is a hollow tubular structure, and the inner diameter of the hollow tubular structure is 0.5-1.5 mm, The hollow tubular structure has an outer diameter of 0.6 to 4.0 mm. The artificial nasolacrimal duct is made of a water swellable material.

During the treatment, the inner diameter of the hollow tubular structure is smaller than the inner diameter of the human nasolacrimal duct, and the physician can easily introduce the artificial nasolacrimal duct into the human nasolacrimal duct, and the artificial nasolacrimal duct is made of an absorbent swellable material and implanted into the human body. After the nasolacrimal duct, it can swell and fill, and fill the nasolacrimal duct of the human body to achieve self-fixation effect. The artificial nasolacrimal duct of the invention has a simple structure, and does not need to be configured to have a structure whose end size is larger than the physiological size of the lacrimal passage to achieve the purpose of fixation, and has a good fixation effect, and is not easy to fall off after water swelling. When used, artificial nasolacrimal ducts of different sizes can be selected according to different people's needs.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the inner surface and the outer surface of the artificial nasolacrimal duct are smooth surfaces.

The smooth surface refers to the outer surface of the artificial nasolacrimal duct without any modification. The artificial nasolacrimal duct of the present invention forms a water film layer on a smooth surface after water swelling, and the surface is smoother.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the water swellable material has a water absorption thickness expansion ratio of 1.5 to 2.

When the artificial nasolacrimal duct of the present invention adopts the above material with water absorption thickness expansion rate, the artificial nasolacrimal duct can reach the size suitable for the human nasolacrimal duct after absorbing water and swelling.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the water swellable material comprises a hydrogel;

The hydrogel comprises the following parts by weight of the preparation material:

10 to 80 parts of hydroxyethyl methacrylate, 1 to 20 parts of a crosslinking agent, 10 to 80 parts of water, and 0.042 to 36 parts of a reaction initiator;

The crosslinking agent is at least one of polyethylene glycol diacrylate, ethylene glycol dimethacrylate and triallyl isocyanurate; the reaction initiator is a mixture of a thermal initiator and a catalyst Or a photoinitiator.

The hydrogel used in the artificial nasolacrimal duct of the present invention uses hydroxyethyl methacrylate (HEMA) as a substrate, and has the following advantages: (1) The material prepared by using the above raw materials has the advantages of good hydrophilicity. Thereby, the artificial nasolacrimal duct of the invention has high tear guiding efficiency; (2) has better biocompatibility and stability, so that the artificial nasolacrimal duct of the invention can obtain longer planting. In the cycle, long-term placement is not easy to cause rejection and inflammatory reaction; (3), can absorb water and swell, can achieve self-fixing effect; (4) simple implantation method, easy to operate; (5) has good mechanical properties.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the ratio of the weight of the thermal initiator to the catalyst is: thermal initiator: catalyst = 1:1 to 3.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the ratio of the weight of the thermal initiator to the catalyst is: thermal initiator: catalyst = 1:2.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the photoinitiator is 2-hydroxy-2-methylpropiophenone and/or 2,4,6-trimethylbenzoyl- Diphenylphosphine oxide; the thermal initiator is at least one of azobisisobutyronitrile, benzoyl peroxide and ammonium persulfate.

As a more preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the photoinitiator is 2-hydroxy-2-methylpropiophenone; and the thermal initiator is ammonium persulfate.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the catalyst is N, N, N', N'-tetramethylethylenediamine.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the hydrogel comprises the following raw materials by weight: 30-60 parts of hydroxyethyl methacrylate, polyethylene glycol diacrylate 1 ～20 parts, 30 to 60 parts of water, 0.93 to 11.2 parts of ammonium persulfate, and 0.93 to 11.2 parts of a catalyst.

The artificial nasolacrimal duct prepared by the above formula has better water absorption performance and mechanical properties.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the hydrogel comprises the following raw materials by weight: 40 parts of hydroxyethyl methacrylate and 20 parts of polyethylene glycol diacrylate. 40 parts of water, 5 parts of ammonium persulfate and 10 parts of catalyst.

The artificial nasolacrimal duct prepared by the above formula has the best water absorption performance and mechanical properties.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the water swellable material comprises at least one of hyaluronic acid, sodium alginate and collagen.

Hyaluronic acid, sodium alginate and collagen have good biocompatibility, are degradable, and can be used as materials for artificial nasolacrimal ducts.

As a preferred embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention, the artificial nasolacrimal duct has a length of 2 to 5 cm. The length of the artificial nasolacrimal duct can be selected according to the needs of different people.

The invention has the advantages that the artificial nasolacrimal duct of the invention has a simple structure, and does not need to be arranged to have a structure whose end size is larger than the physiological size of the lacrimal passage to achieve the purpose of fixation, and has a good fixation effect, and is not easy to fall off after water swelling.

DRAWINGS

1 is a schematic structural view of a self-expanding and fixed artificial nasolacrimal duct according to Examples 1 to 23;

1A is an artificial nasolacrimal duct before water swelling; FIG. 1B is an artificial nasolacrimal duct after water swelling.

2 is a test result of swelling performance of the artificial nasolacrimal ducts of Examples 1 to 9.

Detailed ways

The present invention will be further described with reference to specific embodiments in order to better illustrate the objects, aspects and advantages of the invention.

The structural schematic diagram of the self-expanding fixed artificial nasolacrimal duct described in Examples 1-23 is shown in FIG.

1A is a schematic structural view of an artificial nasolacrimal duct before water swelling, that is, a state before being implanted into a human nasolacrimal duct, the artificial nasolacrimal duct is a hollow tubular structure, and the inner surface of the tube and the outer surface of the tube are smooth. The surface of the artificial nasolacrimal duct is d1 and the outer diameter is D1. FIG. 1B is a schematic view showing the structure of the artificial nasolacrimal duct after being artificially swelled into the human body, and the artificial nasolacrimal duct is inflated. The thickness of the tube wall is increased, the outer diameter of the artificial nasolacrimal duct is increased, and the human nasolacrimal duct is filled, and the artificial nasolacrimal duct is self-fixed. At this time, the artificial nasolacrimal duct has an inner diameter of d2 and an outer diameter of D2.

Example 1

An embodiment of the artificial nasolacrimal duct of the present invention comprises the following parts by weight: preparation raw materials: 40 parts of hydroxyethyl methacrylate, 20 parts of cross-linking agent, 40 parts of water, 5 parts of thermal initiator and 10 parts of catalyst;

Wherein the crosslinking agent is polyethylene glycol diacrylate, the thermal initiator is azobisisobutyronitrile, and the catalyst is N, N, N', N'-tetramethylethylenediamine.

An artificial nasolacrimal duct prepared by using the preparation material of the artificial nasolacrimal duct of the embodiment, the preparation method of the artificial nasolacrimal duct comprises the following steps:

(1) mixing hydroxyethyl methacrylate, a crosslinking agent, water, an initiator and a catalyst uniformly, and injecting into a artificial nasolacrimal duct mold;

(2), the artificial nasolacrimal duct mold containing the artificial nasolacrimal tube preparation raw material obtained in the step (1) is reacted at 50 ° C for 24 hours to obtain a shaped artificial nasolacrimal duct;

(3), the formed artificial nasolacrimal duct was taken out from the artificial nasolacrimal duct mold, washed with water for 3 days, taken out, and vacuum dried for 24 hours, that is, an artificial nasolacrimal duct was obtained.

Before use, the inner diameter d1 of the artificial nasolacrimal duct of the present embodiment is 1.2 mm, and the external „D1 is 1.4 mm. After being implanted into the human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after the water swell is hardly changed. The inner diameter d2 is still 1.2 mm and the outer diameter D2 is 2.3 mm.

Example 2

An artificial nasolacrimal duct according to the present invention, the artificial nasolacrimal duct of the present embodiment is different from the first embodiment only in the ratio of the thermal initiator to the catalyst, and the artificial nasolacrimal duct of the embodiment The following raw materials are included in the following parts by weight: 40 parts of hydroxyethyl methacrylate, 20 parts of a crosslinking agent, 40 parts of water, 5 parts of a thermal initiator, and 5 parts of a catalyst;

Wherein the crosslinking agent is polyethylene glycol diacrylate, the thermal initiator is azobisisobutyronitrile, and the catalyst is N, N, N', N'-tetramethylethylenediamine.

The preparation method of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

The size of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Example 3

An artificial nasolacrimal duct according to the present invention, the artificial nasolacrimal duct of the present embodiment is different from the first embodiment only in the ratio of the thermal initiator to the catalyst, and the artificial nasolacrimal duct of the embodiment The preparation material comprises the following parts by weight: 40 parts of hydroxyethyl methacrylate, 20 parts of crosslinking agent, 40 parts of water, 5 parts of thermal initiator and 15 parts of catalyst;

Wherein the crosslinking agent is polyethylene glycol diacrylate, the thermal initiator is azobisisobutyronitrile, and the catalyst is N, N, N', N'-tetramethylethylenediamine.

The preparation method of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

The size of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Example 4

An embodiment of the artificial nasolacrimal duct of the present invention comprises the following raw materials in parts by weight: 40 parts of hydroxyethyl methacrylate, 30 parts of a crosslinking agent, 40 parts of water, 5 parts of a thermal initiator and 5 parts of a catalyst;

Wherein the crosslinking agent is polyethylene glycol diacrylate, the thermal initiator is azobisisobutyronitrile, and the catalyst is N, N, N', N'-tetramethylethylenediamine.

The preparation method of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

The size of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Example 5

An embodiment of the artificial nasolacrimal duct of the present invention comprises the following raw materials in parts by weight: 40 parts of hydroxyethyl methacrylate, 20 parts of a crosslinking agent, 30 parts of water, and 11 parts of a photoinitiator;

Wherein the crosslinking agent is polyethylene glycol diacrylate, and the photoinitiator is 2-hydroxy-2-methylpropiophenone.

An artificial nasolacrimal duct prepared by using the preparation material of the artificial nasolacrimal duct of the embodiment, the preparation method of the artificial nasolacrimal duct comprises the following steps:

(1) mixing hydroxyethyl methacrylate, a crosslinking agent, water, a photoinitiator and a catalyst uniformly into an artificial nasolacrimal tube mold;

(2), the artificial nasolacrimal duct mold containing the artificial nasolacrimal tube preparation raw material obtained in the step (1) is reacted at 25 ° C for 24 hours to obtain a shaped artificial nasolacrimal duct;

(3), the formed artificial nasolacrimal duct was taken out from the artificial nasolacrimal duct mold, washed with water for 3 days, taken out, and vacuum dried for 24 hours, that is, an artificial nasolacrimal duct was obtained.

The size of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Example 6

An embodiment of the artificial nasolacrimal duct of the present invention comprises the following raw materials in parts by weight: 40 parts of hydroxyethyl methacrylate, 20 parts of a crosslinking agent, 30 parts of water, and 11 parts of a photoinitiator;

Wherein the crosslinking agent is triallyl isocyanurate and the photoinitiator is 2,4,6-trimethylbenzoyl-diphenylphosphine oxide.

The preparation method of the artificial nasolacrimal duct of the present embodiment is the same as that of the embodiment 5.

The size of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Example 7

An embodiment of the artificial nasolacrimal duct of the present invention comprises the following raw materials by weight: 10 parts of hydroxyethyl methacrylate, 1 part of cross-linking agent, 10 parts of water and 0.042 parts of photoinitiator;

Wherein the crosslinking agent is ethylene glycol dimethacrylate, and the photoinitiator is 2,4,6-trimethylbenzoyl-diphenylphosphine oxide.

The preparation method of the artificial nasolacrimal duct of the present embodiment is the same as that of the embodiment 5.

The size of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Example 8

An embodiment of the artificial nasolacrimal duct of the present invention comprises the following raw materials in parts by weight: 80 parts of hydroxyethyl methacrylate, 10 parts of a crosslinking agent, 10 parts of water, 10 parts of a thermal initiator and 10 parts of a catalyst;

Wherein the crosslinking agent is polyethylene glycol diacrylate, the thermal initiator is benzoyl peroxide, and the catalyst is N, N, N', N'-tetramethylethylenediamine.

The preparation method of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

The size of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Example 9

An embodiment of the artificial nasolacrimal duct of the present invention comprises the following raw materials in parts by weight: 10 parts of hydroxyethyl methacrylate, 10 parts of a crosslinking agent, 80 parts of water, 3 parts of a thermal initiator and 3 parts of a catalyst;

Wherein the crosslinking agent is polyethylene glycol diacrylate, the thermal initiator is azobisisobutyronitrile, and the catalyst is N, N, N', N'-tetramethylethylenediamine.

The preparation method of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

The size of the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Example 10

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.0 mm and an outer diameter D1 of 1.2 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.0 mm and the outer diameter D2 is 2.0 mm.

Example 11

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.5 mm and an outer diameter D1 of 1.8 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.5 mm and the outer diameter D2 is 2.8 mm.

Example 12

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 0.5 mm and an outer diameter D1 of 0.8 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 0.5 mm and the outer diameter D2 is 1.5 mm.

Example 13

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 0.9 mm and an outer diameter D1 of 1.1 mm. After being implanted into the human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 0.9 mm and the outer diameter D2 is 1.8 mm.

Example 14

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 0.8 mm and an outer diameter D1 of 1.0 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 0.8 mm and the outer diameter D2 is 1.6 mm.

Example 15

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.1 mm and an outer diameter D1 of 1.4 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.1 mm and the outer diameter D2 is 2.3 mm.

Example 16

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.2 mm and an outer diameter D1 of 1.4 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.2 mm and the outer diameter D2 is 2.5 mm.

Example 17

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.3 mm and an outer diameter D1 of 1.4 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.3 mm and the outer diameter D2 is 2.4 mm.

Example 18

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.0 mm and an outer diameter D1 of 1.3 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.0 mm and the outer diameter D2 is 2.0 mm.

Example 19

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 0.5 mm and an outer diameter D1 of 0.6 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 0.5 mm and the outer diameter D2 is 1.0 mm.

Example 20

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is the same as that of the first embodiment.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.5 mm and an outer diameter D1 of 4.0 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.5 mm and the outer diameter D2 is 6.5 mm.

Example 21

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the embodiment is hyaluronic acid.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.0 mm and an outer diameter D1 of 1.2 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.0 mm and the outer diameter D2 is 2.0 mm.

Example 22

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of this embodiment is sodium alginate.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.0 mm and an outer diameter D1 of 1.2 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.0 mm and the outer diameter D2 is 1.9 mm.

Example 23

An embodiment of the self-expanding fixed artificial nasolacrimal duct of the present invention.

The material used in the artificial nasolacrimal duct of the present embodiment is collagen.

Before use, the artificial nasolacrimal duct of the present embodiment has an inner diameter d1 of 1.0 mm and an outer diameter D1 of 1.2 mm. After being implanted into a human nasolacrimal duct, the inner diameter of the artificial nasolacrimal duct after water swelling is hardly changed. The inner diameter d2 is still 1.0 mm and the outer diameter D2 is 2.2 mm.

Example 24

100 artificial nasolacrimal ducts in Examples 1, 4, and 5 were randomly selected for cytotoxicity test. Examples 1, 4, and 5 were used as test groups 1 to 3, respectively. The test procedure was as follows: according to the ratio of 125 mg/L. 125 mg of the 1, 4, and 5 hydrogel samples were placed in an EP tube and swelled with distilled water overnight; the next day, the distilled water in the EP tube was blotted, and the hydrogel was autoclaved for 1.5 h, and then dried in an oven; Amount of 0.007g of acrylamide (0.7% acrylamide) was placed in the EP tube; 1 mL of DMEM medium was added to the ultra-clean workbench, the sealing film was wrapped, placed in a small blue bottle, and placed in an incubator. 48h; Human immortalized epithelial cells (Hacat) in logarithmic growth phase were digested with trypsin and counted to prepare a cell suspension with a cell density of 7×10 4 cells/mL, and seeded in a 96-well plate at 200 μL/well. After incubating in the incubator for 24 hours, the original culture solution was discarded, the blank control group was exchanged with fresh DMEM medium, the positive control group was exchanged with 0.7% acrylamide, and the experimental group was added with hydrogel extract, which was 200 μL/ Hole; after 48 hours of incubation in the incubator, the plate was removed and 20 μL/well of MTT was added. Continue to culture for 4-6h; then discard the liquid in the well, add 150μL/well of DMSO, shake for 10min, use the microplate reader to detect the light absorption value (OD) at 490nm wavelength, take the average value of four holes, the relative cell proliferation rate (relative growth rate, RGR) = (test group absorbance / control absorbance) × 100%. The relative nucleation rate of the cells was converted into a gradation reaction to evaluate the cytotoxicity of the samples. The evaluation criteria are shown in Table 1:

Table 1 Reaction grading standards

Note: Level 0 or Class 1 reaction indicates that the material sample is not toxic; in the second-order reaction, it is necessary to observe the cell morphology by microscope, and combine with the change of cell morphology to judge whether the material sample is toxic to the cells; the reaction of level 3 or above, Indicate that the material sample is toxic to the cells.

The cytotoxicity test results are shown in Table 2.

Table 2 Cytotoxicity test results

It can be seen from the results of Table 2 that the RGR is above 80%, indicating that the artificial nasolacrimal duct prepared by the hydrogel of the present invention is non-toxic.

Example 25

The artificial nasolacrimal ducts of the embodiments 1 to 9 of the same size were subjected to a swelling performance test, and the test results are shown in Fig. 2.

It can be seen from FIG. 2 that the artificial nasolacrimal duct of the present invention can absorb water and swell, and the water absorbing thickness expansion ratio is 1.5 to 2, and it is not easy to fall off after expansion, and the self-fixing effect is achieved, wherein the water absorbing thickness expansion rate of the embodiment 1 is the highest; It can be seen from the water absorbing thickness expansion ratios of Examples 1 to 3 that the water absorbing thickness expansion ratio is higher when the weight ratio of the thermal initiator to the catalyst is 1:2; the water absorbing thickness expansion ratios of Examples 5 and 6 can be It can be seen that when the photocatalyst is 2-hydroxy-2-methylpropiophenone, the water swelling effect is better.

It should be noted that the above embodiments are only intended to illustrate the technical solutions of the present invention and are not intended to limit the scope of the present invention, although the present invention will be described in detail with reference to the preferred embodiments, The technical solutions of the present invention may be modified or equivalently substituted without departing from the spirit and scope of the technical solutions of the present invention.

Claims (10)

A self-expanding fixed artificial nasolacrimal duct, characterized in that the artificial nasolacrimal duct is a hollow tubular structure, the inner diameter of the hollow tubular structure is 0.5-1.5 mm, and the outer diameter of the hollow tubular structure is 0.6- 4.0 mm; the artificial nasolacrimal duct is made of a water swellable material. The self-expanding fixed artificial nasolacrimal duct according to claim 1, wherein the water swellable material has a water absorption thickness expansion ratio of 1.5 to 2. A self-expanding fixed artificial nasolacrimal duct according to claim 2, wherein said water swellable material comprises a hydrogel; The hydrogel comprises the following parts by weight of the preparation material: 10 to 80 parts of hydroxyethyl methacrylate, 1 to 20 parts of a crosslinking agent, 10 to 80 parts of water, and 0.042 to 36 parts of a reaction initiator; The crosslinking agent is at least one of polyethylene glycol diacrylate, ethylene glycol dimethacrylate and triallyl isocyanurate; the reaction initiator is a mixture of a thermal initiator and a catalyst Or a photoinitiator. A self-expanding fixed artificial nasolacrimal duct according to claim 3, wherein the ratio of the weight of the thermal initiator to the catalyst is: thermal initiator: catalyst = 1:1 to 3; preferably, the heat The weight ratio of initiator to catalyst is: thermal initiator: catalyst = 1:2. The artificial nasolacrimal tube according to claim 1, wherein said photoinitiator is 2-hydroxy-2-methylpropiophenone and/or 2,4,6-trimethylbenzoyl-diphenyl. a phosphine oxide; the thermal initiator is at least one of azobisisobutyronitrile, benzoyl peroxide and ammonium persulfate; preferably, the photoinitiator is 2-hydroxy-2-methylpropiophenone The thermal initiator is ammonium persulfate. A self-expanding fixed artificial nasolacrimal duct according to claim 3, wherein the catalyst is N, N, N', N'-tetramethylethylenediamine. The self-expanding and fixed artificial nasolacrimal duct according to claim 5, wherein the hydrogel comprises the following raw materials by weight: 30-60 parts of hydroxyethyl methacrylate, polyethylene glycol diacrylate 1 to 20 parts, 30 to 60 parts of water, 0.93 to 11.2 parts of ammonium persulfate, and 0.93 to 11.2 parts of a catalyst. The self-expanding and fixed artificial nasolacrimal duct according to claim 5, wherein the hydrogel comprises the following raw materials in parts by weight: 40 parts of hydroxyethyl methacrylate and 20 parts of polyethylene glycol diacrylate. 40 parts of water, 5 parts of ammonium persulfate and 10 parts of catalyst. A self-expanding fixed artificial nasolacrimal duct according to claim 2, wherein said water swellable material comprises at least one of hyaluronic acid, sodium alginate and collagen. The self-expanding fixed artificial nasolacrimal duct according to claim 1, wherein the artificial nasolacrimal duct has a length of 2 to 5 cm.

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