KR20180034848A - Hydrophilic medical catheter and manufacturing method thereof - Google Patents

Abstract

The present invention relates to a hydrophilic medical catheter which significantly increases lubrication on a surface of the catheter on which friction occurs when the catheter is inserted into a body by enhancing hydrophilicity of the catheter by forming a first plasma coating on the surface of the catheter and forming a second coating layer containing oxidized polysaccharide and a hydrophilic polymer on the first plasma coating. The hydrophilic medical catheter manufactured according to the present invention is excellent in biocompatibility and maintains a self-lubricating property of the surface of the catheter so that no lubricant treatment process is needed before insertion into the human body conduit, and can be applied to various medical conduits to be inserted into the conduit in the body including the catheter as well as blood vessels since no side effects such as perforation and separation of the human body conduit and tissue damage occur.

Description

[0001] Hydrophilic medical catheter and manufacturing method [0002]

The present invention relates to a hydrophilic medical catheter and a method of manufacturing the same, and more particularly, to a method of manufacturing a hydrophilic medical catheter by forming a first plasma coating layer on a surface of a catheter and forming a second coating layer containing an oxidizing polysaccharide and a hydrophilic polymer on the plasma first coating layer And a hydrophilic medical catheter for improving the hydrophilicity of the catheter and greatly increasing the lubricity on the surface of the catheter where friction occurs with the tissue during insertion into the human body.

In general, a catheter is a thin tube formed by extrusion molding using a medical material, and is generally referred to as a catheter inserted into a human body for the purpose of treating a disease or performing surgery. That is, since the catheter is applied to a variety of clinical fields such as cardiovascular, urinary and digestive machines, it is inserted into a human body such as steel, a tube, and a blood vessel. Particularly, in order to diagnose or treat ischemic cardiovascular diseases such as arteriosclerosis and angina pectoris, a guiding catheter and a balloon catheter are inserted through the femoral or wrist aorta into the narrowed blood vessel region, and then the balloon is inflated to expand the coronary artery Percutaneous transluminal coronary angioplasty.

However, the success rate of percutaneous coronary angioplasty was 84 ~ 92%, which is higher than the initial success rate of 50 ~ 60%, but there is still a problem of 20 ~ 65% restenosis depending on the site of vascular stenosis. In addition, since most of the catheters used in intracorporeal catheter insertion including percutaneous coronary angioplasty are hydrophobic polymers such as polyethylene, polytetrafluoroethylene, polyamide, polyurethane, silicone, and the like, A certain pressure is required to insert into the body conduit. In addition, since the human body conduit is not distributed in a certain shape or angle in the human body, sufficient lubricity should be given to the surface of the catheter for smooth insertion into the human body conduit. In addition, if such lubrication is not sufficient, there is a risk that the catheter will rub against the inner wall of the body conduit during insertion of the catheter into the body conduit, resulting in side effects such as puncturing or separation of the conduit, Reported.

Therefore, prior to inserting the catheter into the body conduit in order to alleviate the above-mentioned side effects, a water-soluble lubricant may be applied to the surface of the catheter to impart lubrication to the catheter. However, in the process of inserting the catheter into the body conduit, And the frictional force between the catheter and the inner wall of the body conduit may be recovered again, which makes it difficult to easily operate the catheter when the catheter is inserted (Patent Documents 1 to 3).

Therefore, the present inventors have solved the problems caused by the use of conventional medical catheters, and have not yet developed a medical catheter in which a plasma coating layer and a coating layer based on a mixture of oxidizing polysaccharide and hydrophilic polymer are formed on the plasma coating layer Attention is paid to the negative, and when the surface of a conventional medical catheter is first coated with a plasma and then co-coated with a mixture of oxidized polysaccharides and a hydrophilic polymer, the hydrophilicity is further improved and the lubricity can be greatly increased upon insertion into a human body catheter. And thus completed the present invention.

Patent Document 1: Japanese Patent Application Laid-Open No. 10-2013-0122538 Patent Document 2: JP-A-10-1168676 Patent Document 3: Registered Patent Publication No. 10-1124599

SUMMARY OF THE INVENTION The present invention has been made in view of the above problems, and it is an object of the present invention to provide a catheter that has excellent biocompatibility and maintains self-lubricating property of a surface of a catheter, And a second coating layer containing oxidized polysaccharide and hydrophilic polymer on the plasma first coating layer, and a method for manufacturing the same. The present invention also provides a medical catheter comprising the first coating layer and the second coating layer, wherein the first coating layer does not cause side effects such as puncturing, .

In order to achieve the above object, the present invention provides a medical catheter,

A plasma first coating layer on the surface of the catheter; And a second coating layer containing the oxidized polysaccharide and the hydrophilic polymer on the plasma first coating layer.

The oxidized polysaccharide may be selected from the group consisting of oxidized carboxymethylcellulose, carboxyethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, dextrin, dextran, dextran sulfate, alginic acid, hyaluronic acid, chitin, chitosan, gellan gum, glucan, And at least one selected from the group consisting of chondroitin sulfate, glycogen, starch, cellulose, regenerated cellulose, maltodextrin, fructan, galactan and mannan.

The oxidized polysaccharide is characterized in that the molecular weight of the polysaccharide before oxidation is 1,000 to 100,000.

The oxidation polysaccharide has an oxidation degree of 5 to 70%.

The hydrophilic polymer may include polyethylene glycol or polypropylene glycol having a carbon-carbon double bond at the terminal, polyethylene glycol or polypropylene glycol having an amine group at the terminal, polyacrylamide, polyhydroxy methyl methacrylate, polyhydroxyethyl methacrylate Polyacrylic acid, polymethacrylic acid, and poly (N-isopropylacrylamide).

The present invention also relates to a method of manufacturing a plasma processing apparatus, comprising the steps of: I) treating a surface of a catheter with a plasma to form a first plasma coating layer; II) mixing the oxidant aqueous solution and the polysaccharide aqueous solution to obtain an oxidation reaction mixture; III) washing the oxidation reaction mixture with ethanol for several times, filtering and drying to obtain a powdery oxidized polysaccharide; IV) mixing the oxidized polysaccharide solution in which the powdery oxidized polysaccharide is dissolved and the hydrophilic polymer solution to obtain a coating solution; And V) coating the coating solution on the plasma first coating layer to form a second coating layer. The present invention also provides a method for manufacturing a hydrophilic medical catheter.

In the step I), the plasma may be a bar type or a spin jet type plasma spraying machine.

The oxidizing agent is at least one selected from the group consisting of hydrogen peroxide, iron nitrate, ozone, peracetic acid, potassium permanganate, potassium peroxodisulfate, potassium peroxodisulfate, sodium periodate, sodium bromate, sodium perborate and sodium percarbonate .

The polysaccharide may be selected from the group consisting of carboxymethylcellulose, carboxyethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, dextrin, dextran, dextran sulfate, alginic acid, hyaluronic acid, chitin, chitosan, gellan gum, glucan, betaglucan, chondroitin sulfate, And at least one selected from the group consisting of glycogen, starch, cellulose, regenerated cellulose, maltodextrin, fructan, galactan and mannan.

The oxidant aqueous solution has a concentration of 0.1 to 40% by weight.

The polysaccharide aqueous solution has a concentration of 1 to 30% by weight.

The oxidation reaction is performed at 25 to 37 ° C for 1 to 96 hours in an atmosphere in which light is blocked.

The oxidized polysaccharide solution has a concentration of 5 to 40% by weight.

The hydrophilic polymer solution has a concentration of 0.1 to 20% by weight.

A first plasma coating layer on the surface of the catheter, prepared according to the present invention; And a second coating layer containing the oxidized polysaccharide and the hydrophilic polymer on the plasma first coating layer. The hydrophilic medical catheter is excellent in biocompatibility and maintains the self-lubricating property of the surface of the catheter, In addition, there are no side effects such as perforation and separation of the body conduit, tissue damage, etc., so that it can be applied to various medical conduits to be inserted into the body conduit including the catheter as well as the blood vessel.

FIG. 1 is a graph showing the results of measurement of a trackability force when a catheter having a plasma primary coating layer formed according to the present invention and a conventional commercialized catheter are inserted into a tube.
FIG. 2 is a graph showing the results of measurement of the trackability force when inserting the medical catheter manufactured from Example 8 and Comparative Example 8 of the present invention and a conventional commercialized catheter into a tube.
FIG. 3 is a graph showing a result of measuring a trackability force when inserting a medical catheter manufactured from Examples 1, 4, and 7 of the present invention into a tube. FIG.
4 is a graph showing the results of measuring the trackability force when inserting a medical catheter manufactured from Examples 7 to 9 of the present invention into a tube.

Hereinafter, a hydrophilic medical catheter according to the present invention and a method for manufacturing the same will be described in detail.

First, the present invention provides a medical catheter, comprising: a plasma first coating layer on a surface of the catheter; And a second coating layer containing the oxidized polysaccharide and the hydrophilic polymer on the plasma first coating layer.

Generally, since the main material of a catheter generally used is hydrophobic, its nature is different from that of a body fluid composed of more than 90% water which is filled in a human body conduit. Therefore, in the related art, hydrophilic material is coated on the surface of the hydrophobic catheter, and various side effects such as perforation of the catheter, tissue damage and the like which may be caused in the process of inserting the catheter into the human body can be partially solved. However, coating of a hydrophilic material alone makes it difficult to achieve complete lubrication when inserting the catheter into the body conduit. Particularly, among such hydrophilic substances, the reactive functional groups of the hydrophilic polymer are mainly polar and are likely to be easily separated from the surface of the catheter by dissolving or swelling when they come in contact with a hydrophilic (polar) body fluid.

Accordingly, in the present invention, in order to maintain a specific lubricity in spite of a considerable friction and abrasion force appearing when the catheter is inserted, the surface of the catheter is treated with plasma to form a first plasma coating layer, and the oxidized polysaccharide and the hydrophilic polymer A second coating layer containing a mixture of the first coating layer and the second coating layer is formed.

The surface coating process of the medical catheter using the plasma is characterized in that the coating thickness and the film properties can be easily controlled by adjusting the process parameters such as precursor type, input power, treatment time, plasma gas type, Which is free of pinholes and has a high density of crosslinking, which is useful as a hydrophilic coating method.

The coating of the surface of the catheter using the plasma is performed by supplying a reactive gas into the plasma reactor to activate the plasma reactor and uniformly dispersing the plasma on the surface of the catheter at a nanoscale to impart hydrophilicity to the surface of the catheter, Increases lubrication on insertion to facilitate catheter insertion and reduces thrombus formation that can occur during catheter insertion.

The plasma first coating layer may be formed using a plasma spraying machine of a bar type or a spin jet type.

At this time, the plasma coating using the bar type injector is a method in which a voltage is applied in a bar shaped vessel in which a plasma is trapped, and the plasma is sprayed toward the roll rotating under the bar by applying heat . The bar type injector uses an electrode of N2 DBD (Dielectric Barrier Discharge) of 300 mm. Depending on the application of the plasma treatment, the output, the clean dry air, the gap between the portion where the plasma is output and the surface of the catheter, And the processing conditions such as the processing speed are appropriately controlled.

In addition, a plasma jet using a spin jet type sprayer uses a spin jet electrode. When a plasma is sprayed by applying an output to a container containing a plasma, the plasma is sprayed to the air extruder And the plasma spraying vessel is moved left and right by air extrusion to coat the fixed sample. Depending on the application of the plasma treatment, as in the case of using a bar type plasma sprayer, the process conditions such as output, clean dry air, gap between the portion of the plasma output and the surface of the catheter, .

In addition, the second coating layer containing the mixture of the oxidized polysaccharide and the hydrophilic polymer has hydrophilicity added to the surface of the catheter having hydrophilicity only by the plasma first coating layer by laminating the hydrophilic coating layer on the plasma first coating layer, And significantly increases the lubrication on the catheter surface.

That is, when the hydroxyl group of the polysaccharide is oxidized by the oxidizing agent, the aliphatic cyclic structure is changed to an aldehyde group, and a reactor capable of inducing chemical bonding with the surface of the catheter having the first plasma coating layer is formed. It is possible to form a coating layer on the surface of the catheter where the first plasma coating layer is formed by the chemical bonding of the oxidized polysaccharide. Since oxidized polysaccharides are basically hydrophilic, they maximize hydrophilicity on the surface of the catheter where the plasma first coating layer is formed by mixing with the hydrophilic polymer, thereby reducing the friction between the catheter surface and the inner wall of the catheter, In addition, it is possible to facilitate the insertion of a series of catheter insertion operations in which the operator inserts the catheter into the body conduit and then moves to the lesion site. In addition, Thereby reducing the risk of perforation and separation of the human body, tissue damage, and the like. Furthermore, even if a part of the hydrophilic polymer and the oxidized polysaccharide are separated by friction with the body fluid or the inner wall of the conduit, they can be decomposed and discharged in vivo by the water in the body fluids or blood, and the risk of the blood clotting It is safe to use.

The oxidized polysaccharide may be selected from the group consisting of carboxymethylcellulose, carboxyethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, dextrin, dextran, dextran sulfate, alginic acid, hyaluronic acid, chitin, chitosan, gellan gum, glucan, betaglucan, chondroitin sulfate Means one in which at least one polysaccharide selected from the group consisting of glycogen, starch, cellulose, regenerated cellulose, maltodextrin, fructan, galactan and mannan is oxidized by oxidation reaction.

The molecular weight of the oxidized polysaccharide before oxidation is preferably 1,000 to 100,000. If the molecular weight is less than 1,000, the hydrophilic effect of the surface of the catheter is low and the lubricity may deteriorate. If the molecular weight exceeds 100,000, It is difficult to bond to the surface or decomposition in the living body is slowed, so that it is difficult to discharge and when the body fluid is decomposed, the viscosity of the body fluid may increase.

The degree of oxidation indicating degree of oxidation of the polysaccharide can be defined as a ratio (%) of the conversion of the hydroxyl group of the polysaccharide to the aldehyde by the oxidation reaction with the oxidizing agent and the like. The oxidizing polysaccharide has an oxidation degree of 5 to 70% . If the degree of oxidation is less than 5%, the number of reaction sites capable of chemically bonding with the surface of the catheter having the plasma first coating layer formed therein is decreased, so that it is difficult to bond to the surface or only a small amount may bind, Is more than 70%, it is easily decomposed by moisture, and when stored or contacted with body fluids, the molecular weight may be excessively reduced or eluted and decomposed to degrade the lubricity.

Examples of the hydrophilic polymer include polyethylene glycol or polypropylene glycol having a carbon-carbon double bond at the terminal, polyethylene glycol or polypropylene glycol having an amine at the terminal, polyacrylamide, polyhydroxymethyl methacrylate, polyhydroxyethyl Methacrylate, polyacrylic acid, polymethacrylic acid, and poly (N-isopropylacrylamide) can be preferably used. The hydrophilic polymer may have a molecular weight of 500 to 500,000, more preferably 5000 to 100,000. If the molecular weight is less than 500, the lubricating effect is not sufficient. On the contrary, if the molecular weight is more than 500,000, it is difficult to dissolve and it may be difficult to separate and discharge in the body.

The present invention also relates to a method of manufacturing a plasma processing apparatus, comprising the steps of: I) treating a surface of a catheter with a plasma to form a first plasma coating layer; II) mixing the oxidant aqueous solution and the polysaccharide aqueous solution to obtain an oxidation reaction mixture; III) washing the oxidation reaction mixture with ethanol for several times, filtering and drying to obtain a powdery oxidized polysaccharide; IV) mixing the oxidized polysaccharide solution in which the powdery oxidized polysaccharide is dissolved and the hydrophilic polymer solution to obtain a coating solution; And V) coating the coating solution on the plasma first coating layer to form a second coating layer. The present invention also provides a method for manufacturing a hydrophilic medical catheter.

In the step I), the plasma forms a plasma first coating layer on the surface of the catheter by applying a process condition as described above using a bar type or a spin jet type plasma jet.

The oxidizing agent in the step II) may be selected from the group consisting of hydrogen peroxide, iron nitrate, ozone, peracetic acid, potassium permanganate, potassium peroxodisulfate, potassium peroxodisulfate, sodium periodate, sodium bromate, sodium perborate and sodium percarbonate One or more selected ones may be used, but the present invention is not limited thereto.

Examples of the polysaccharide in step II) include carboxymethyl cellulose, carboxyethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, dextrin, dextran, dextran sulfate, alginic acid, hyaluronic acid, chitin, chitosan, gellan gum, But is not limited to, at least one selected from the group consisting of beta-glucan, chondroitin sulfate, glycogen, starch, cellulose, regenerated cellulose, maltodextrin, fructan, galactan and mannan.

In the step II), the oxidizing agent is mixed with the polysaccharide in an aqueous solution to perform the oxidation reaction. It is preferable that the oxidizing agent solution has a concentration of 0.1 to 40% by weight and the polysaccharide aqueous solution has a concentration of 1 to 30% by weight. At this time, in order to suppress the peroxidation by light or temperature in the process of inducing the oxidation reaction from the oxidation reaction mixture, it is preferable to carry out the oxidation reaction at 25 to 37 ° C for 1 to 96 hours in a light-blocked atmosphere.

Then, the oxidation reaction mixture is washed several times with ethanol, filtered and dried through step III) to obtain a powdery oxidized polysaccharide.

Next, in step IV), a coating solution is obtained by mixing a solution of oxidized polysaccharide in which powdery oxidized polysaccharide is dissolved and a hydrophilic polymer solution. As the solvent for dissolving the oxidized polysaccharide and the hydrophilic polymer in the powder, acetone, N, Organic solvents such as N, N-dimethylformamide (DMF), chloroform, dioxane, tetrahydrofuran (THF), methanol, ethanol, propanol or isopropanol can be preferably used.

 If the concentration of the oxidized polysaccharide solution is less than 5% by weight, the effect of the hydrophilic coating is insignificant. If the concentration of the oxidized polysaccharide solution is more than 40% by weight, It is difficult to coat.

The concentration of the hydrophilic polymer solution is preferably 0.1 to 20% by weight, more preferably 1 to 10% by weight. If the concentration of the hydrophilic polymer solution is less than 0.1 wt%, the concentration is too low to impart a desired degree of lubricity to the surface of the catheter. If the concentration exceeds 20 wt%, the viscosity of the hydrophilic polymer solution becomes too high, A uniform coating can not be expected when coating the surface of the catheter, and when the catheter is inserted into the human body, too much body fluid is absorbed and swollen, which may cause tissue damage due to swelling of the human body conduit.

Finally, a hydrophilic medical catheter according to the present invention is manufactured by coating a coating solution obtained by mixing the oxidized polysaccharide solution and a hydrophilic polymer solution on the plasma first coating layer to form a second coating layer, Any conventional coating method can be used without limitation, but it is preferable that the coating is performed by a dip coating method or a spray coating method in consideration of easiness of coating and uniformity of coating.

The hydrophilic surface treatment process of the medical catheter made through steps I) to V) may be applied not only to general catheters for blood vessels but also to various catheters inserted into the body such as catheters, percutaneous catheters, Catheters, catheters for intracranial pressure measurement, dura mater, subarachnoid and extensor plexus catheters, tube for trachea, drug delivery catheter, and intrauterine catheter.

Hereinafter, embodiments according to the present invention will be described in detail with reference to the accompanying drawings.

[Plasma first coating layer forming step]

Use a bar type plasma sprayer with a N2 DBD 300 mm electrode, 800 W output, 80 lpm (liter per minute) clean dry air, gap 5 between the plasma output and the catheter surface mm, and a plasma treatment rate of 0.5 m / min. In FIG. 1, a catheter having a plasma primary coating layer and a conventional catheter were inserted into a tube The results of measurement of the trackability force are shown in the graph.

 As shown in FIG. 1, the catheter having the first plasma coating layer formed according to the present invention has significantly lower force when the catheter is inserted into the tube than the conventional medical catheter, It can be confirmed that it is greatly improved.

[Production Examples 1 to 3] Preparation of oxidized polysaccharide powders

An oxidizing reaction mixture was obtained by mixing an aqueous solution of an oxidizing agent and a polysaccharide (molecular weight 100,000) as shown in Table 1 below at 25 DEG C for 24 hours (weight ratio 2: 8) using a light shaking incubator. The oxidation reaction mixture was washed three times with ethanol, filtered and dried to prepare oxidized polysaccharide powders.

Manufacturing example Oxidant aqueous solution Polysaccharide aqueous solution Oxidation degree Production Example 1  5% by weight sodium periodate 20% by weight of alginic acid 20% Production Example 2 10% by weight sodium periodate 20% by weight of alginic acid 40% Production Example 3 20 wt% Sodium iodate 20% by weight of alginic acid 60%

[Production Examples 4 to 12] Preparation of hydrophilic coating solution

Alginic acid powders of 20%, 40% and 60% in oxidation degree obtained from Production Examples 1 to 3 were dissolved in acetone to obtain a 10% by weight oxidized polysaccharide solution. On the other hand, polyethylene glycol (PEG, molecular weight: 10,000) having an acrylate group at the terminal was dissolved in acetone to obtain a 5% by weight, 10% by weight and 15% by weight hydrophilic polymer solution. As shown in Table 2 below, a hydrophilic coating solution was prepared by mixing the obtained oxidized polysaccharide solution and a hydrophilic polymer solution (weight ratio 5: 5).

Manufacturing example Oxidized polysaccharide solution (oxidation degree) The hydrophilic polymer solution Production Example 4 10% by weight alginic acid solution (20%)  A PEG solution having an acrylate at 5% by weight end Production Example 5 10% by weight alginic acid solution (20%) A PEG solution having an acrylate at the end of 10% by weight Production Example 6 10% by weight alginic acid solution (20%) A PEG solution having an acrylate at the end of 15% by weight Production Example 7 10% by weight alginic acid solution (40%)  A PEG solution having an acrylate at 5% by weight end Production Example 8 10% by weight alginic acid solution (40%) A PEG solution having an acrylate at the end of 10% by weight Production Example 9 10% by weight alginic acid solution (40%) A PEG solution having an acrylate at the end of 15% by weight Production Example 10 10% by weight alginic acid solution (60%)  A PEG solution having an acrylate at 5% by weight end Production Example 11 10% by weight alginic acid solution (60%) A PEG solution having an acrylate at the end of 10% by weight Production Example 12 10% by weight alginic acid solution (60%) A PEG solution having an acrylate at the end of 15% by weight

[ Example  1 to 9] plasma  Preparation of a catheter having a first coating layer and a second coating layer containing oxidized polysaccharide and hydrophilic polymer

After the first plasma coating layer was formed on the surface of the catheter according to the above-described first plasma coating layer formation process, the coating solution obtained in Production Examples 4 to 12 was dip-coated on the first plasma coating layer to prepare oxidized polysaccharide and hydrophilic polymer Lt; RTI ID = 0.0 > co-layer < / RTI >

[Comparative Examples 1 to 9] Preparation of a catheter having only a coating layer containing oxidized polysaccharide and hydrophilic polymer

A catheter having only a coating layer containing oxidized polysaccharide and hydrophilic polymer was prepared in the same manner as in Examples 1 to 9 except that the plasma first coating layer formation step was not performed.

FIG. 2 is a graph showing the results of measurement of the trackability force when the medical catheter manufactured from Example 8 and Comparative Example 8 of the present invention and the conventional commercialized catheter are inserted into a tube. The medical catheter manufactured from Example 8 and Comparative Example 8 showed that the force applied when inserting the catheter into the tube was significantly lower than that of the conventional medical catheter, and it was confirmed that the lubricity was greatly improved with an increase in hydrophilicity. Particularly, the catheter manufactured from Example 8, in which a plasma primary coating layer is formed on the surface of the catheter, and a second coating layer containing oxidized polysaccharide and hydrophilic polymer is formed on the plasma primary coating layer, The force exerted when inserting the catheter into the tube was lower than that of the catheter prepared from Comparative Example 8 in which only the coating layer containing only the oxidized polysaccharide and the hydrophilic polymer was formed and the hydrophilicity was further improved by the formation of the plasma first coating layer Able to know.

In order to evaluate the effect of oxidation degree of oxidizing polysaccharide which contributes to the formation of the second coating layer to lubricity, a catheter manufactured from Examples 1, 4 and 7, in which oxidation degree of oxidizing polysaccharide is different, The results of measurement of the trackability force are shown in FIG. As shown in FIG. 3, the lower the degree of oxidation of the oxidized polysaccharide, the higher the force applied when the catheter is inserted into the tube, and the lower the lubricity, while the higher the degree of oxidation of the polysaccharide, the higher the lubricity.

In order to evaluate the effect of the concentration of the hydrophilic polymer solution on the lubricity as another parameter contributing to the formation of the second coating layer, the catheter prepared in Examples 7 to 9, in which the concentration of the hydrophilic polymer solution was different, The results of measurement of the trackability force during insertion are shown in FIG. As shown in FIG. 4, the lower the concentration of the hydrophilic polymer solution, the higher the force applied when the catheter is inserted into the tube, and the lower the lubricity, while the higher the concentration of the hydrophilic polymer solution, the higher the lubricity.

Therefore, a first plasma coating layer on the surface of the catheter, prepared according to the present invention; And a second coating layer containing the oxidized polysaccharide and the hydrophilic polymer on the plasma first coating layer. The hydrophilic medical catheter is excellent in biocompatibility and maintains the self-lubricating property of the surface of the catheter, In addition, there are no side effects such as perforation and separation of the body conduit, tissue damage, etc., so that it can be applied to various medical conduits to be inserted into the body conduit including the catheter as well as the blood vessel.

Claims (14)

In a medical catheter,
A plasma first coating layer on the surface of the catheter; And
And a second coating layer containing the oxidized polysaccharide and the hydrophilic polymer on the plasma first coating layer. The composition of claim 1, wherein the oxidized polysaccharide is selected from the group consisting of oxidized carboxymethylcellulose, carboxyethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, dextrin, dextran, dextran sulfate, alginic acid, hyaluronic acid, chitin, chitosan, Wherein the hydrophilic medical catheter is at least one selected from the group consisting of glucose, beta-glucan, chondroitin sulfate, glycogen, starch, cellulose, regenerated cellulose, maltodextrin, fructan, galactan and mannan. 3. The hydrophilic medical catheter according to claim 1 or 2, wherein the oxidized polysaccharide has a molecular weight of the polysaccharide before oxidation of 1,000 to 100,000. The hydrophilic medical catheter according to claim 1 or 2, wherein the oxidized polysaccharide has an oxidation degree of 5 to 70%. The hydrophilic polymer according to claim 1, wherein the hydrophilic polymer is polyethylene glycol or polypropylene glycol having a carbon-carbon double bond at the terminal, polyethylene glycol or polypropylene glycol having an amine at the terminal, polyacrylamide, polyhydroxymethylmethacrylate, Wherein the hydrophilic medical catheter is at least one selected from the group consisting of polyhydroxyethylmethacrylate, polyacrylic acid, polymethacrylic acid, and poly (N-isopropylacrylamide). I) treating the surface of the catheter with a plasma to form a plasma first coating layer;
II) mixing the oxidant aqueous solution and the polysaccharide aqueous solution to obtain an oxidation reaction mixture;
III) washing the oxidation reaction mixture with ethanol for several times, filtering and drying to obtain a powdery oxidized polysaccharide;
IV) mixing the oxidized polysaccharide solution in which the powdery oxidized polysaccharide is dissolved and the hydrophilic polymer solution to obtain a coating solution; And
V) coating the coating solution on the plasma first coating layer to form a second coating layer. [7] The method of claim 6, wherein the plasma in step I) uses a plasma jet device of bar type or spin jet type. 7. The method of claim 6, wherein the oxidant is selected from the group consisting of hydrogen peroxide, iron nitrate, ozone, peracetic acid, potassium permanganate, potassium peroxodisulfate, potassium peroxodisulfate, sodium periodate, sodium bromate, sodium perborate, Lt; RTI ID = 0.0 > hydrophilic < / RTI > medical catheter. The composition of claim 6, wherein the polysaccharide is selected from the group consisting of carboxymethylcellulose, carboxyethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, dextrin, dextran, dextran sulfate, alginic acid, hyaluronic acid, chitin, chitosan, gellan gum, Wherein the hydrophilic medical catheter is at least one selected from the group consisting of beta-glucan, chondroitin sulfate, glycogen, starch, cellulose, regenerated cellulose, maltodextrin, fructan, galactan and mannan. 7. The method of manufacturing a hydrophilic medical catheter according to claim 6, wherein the oxidant aqueous solution has a concentration of 0.1 to 40% by weight. [7] The method according to claim 6, wherein the polysaccharide aqueous solution has a concentration of 1 to 30% by weight. [7] The method of claim 6, wherein the oxidation reaction is performed at 25 to 37 [deg.] C for 1 to 96 hours in a light-blocked atmosphere. [7] The method according to claim 6, wherein the oxidized polysaccharide solution has a concentration of 5 to 40% by weight. The method of manufacturing a hydrophilic medical catheter according to claim 6, wherein the hydrophilic polymer solution has a concentration of 0.1 to 20 wt%.

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