JPH0824327A - Medical treatment appliance having lubricity on surface when wet and its production - Google Patents

Abstract

PURPOSE:To assure an excellent surface lubricity by bonding a hydrophilic polymer having a reactive functional group within the molecule and an insolubilized matter consisting of a polymer having a functional group reactive with this reactive functional group to the surface of a base material of a medical treatment appliance, thereby forming a surface lubricating layer. CONSTITUTION:This medical treatment appliance having lubricity on the surface when wet is obtd. by bonding a hydrophilic polymer having a reactive functional group within the molecule and an insolubilized matter consisting of a polymer having a functional group reactive with this reactive functional group to the surface of a base material of the medical treatment appliance. The reactive functional group of the hydrophilic polymer is composed of an epoxy group and further, an antithrombus agent is included in the surface lubricating layer. Testing of the surface lubricity is executed for example, by placing a columnar weight 2 made of brass having a weight of 1kg in water 1 for example, on a sheet 4 adhered to an inclined plastic plate, moving this weight at a speed 100cm/min upward and downward in 100 repetitions in 1cm width and evaluating the surface lubricity by a change in friction resistance in this time.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device having excellent surface lubricity or antithrombotic property and a method for producing the same.

[0002]

2. Description of the Related Art Generally, medical devices such as catheters are
To reduce tissue damage such as blood vessels and improve operability for accessing the target site, a low friction material is used on the surface of the base material, and a lubricant is used to reduce the friction of the material surface. , Low friction resin, hydrophilic polymer, etc. are coated.

For example, fluororesin or polyethylene resin is used as the low friction base material, or fluororesin, silicone resin, silicone oil, olive oil, glycerin or the like is applied to the surface of the material. However, many of these methods have problems in terms of safety and sustainability of effects such as desorption, peeling, and elution of the lubricating substance from the surface of the base material.

In recent years, a method of coating a hydrophilic polymer has been studied from the viewpoint of practicality. For example,
U.S. Pat. No. 4,100,309 discloses a method of coating a hydrophilic polymer (polyvinylpyrrolidone) with an isocyanate. Also disclosed is a method of coating a hydrophilic polymer obtained by copolymerizing a reactive functional group using isocyanate (JP-A-59-81341) and a method of coating polyethylene oxide (JP-A-58-193766). There is. In addition, Japanese Patent Publication 1-55023
Describes a method of binding a copolymer such as polyether, polyamide, or polysiloxane via polyisocyanate to the surface on which at least one kind of amino group, imino group, carboxyl group and mercapto group is present. Has been done.

Further, WO 90/01344 discloses a method in which a polymer having a reactive functional group is applied to the surface of a substrate and then a hydrophilic polymer having a reactive functional group capable of reacting with the reactive functional group is coated. Has been described.

In the above various surface lubrication methods, two kinds of compounds, an isocyanate compound and a hydrophilic polymer, must be uniformly coated, or a plurality of coating operations (for example, coating with a crosslinkable compound such as polyisocyanate). Hydrophilic polymer coating)
Was required, which was not preferable in terms of operability. In addition, a compound having a plurality of reactive functional groups such as an isocyanate group in the molecule has high reactivity and easily reacts with moisture and impurities in the air, which makes management of steps and reagents complicated. However, there are drawbacks such as being harmful to the human body.

[0007] Yet another problem is the blood compatibility of lubricated surfaces. Since thrombus formation and activation of platelets lead to functional deterioration of medical devices and occurrence of complications for living bodies, medical devices having a highly blood compatible surface are required. However, many conventional lubricious surfaces do not have sufficient antithrombotic properties, or have some antithrombogenic properties, but lack the strength and slipperiness of the lubricating layer, so that they are complicatedly bent. It was difficult to insert into a blood vessel.

[0008]

SUMMARY OF THE INVENTION An object of the present invention is to solve the above problems and provide a medical device having excellent surface lubricity or antithrombotic property, and a simple method for producing the same.

[0009]

The above object can be achieved by the present invention described below. (1) An insolubilized product composed of a hydrophilic polymer having a reactive functional group in the molecule and a polymer having a functional group capable of reacting with the reactive functional group is bonded to the surface of a base material of a medical device to form a surface lubricating layer. A medical device having a surface having lubricity when wet. (2) The medical device according to (1), wherein the reactive functional group of the hydrophilic polymer is an epoxy group, the surface of which has lubricity when wet. (3) The medical device according to (1) or (2), wherein the surface lubricating layer contains an antithrombotic agent, the surface of which has lubricity when wet. (4) A polymer solution prepared by dissolving a mixture of a hydrophilic polymer having a reactive functional group in its molecule and a polymer having a functional group capable of reacting with the reactive functional group in a solvent is used as a base material for medical devices. A method for producing a medical device having a surface having lubricity when wet, characterized in that the surface is impregnated and further insolubilized to form a surface lubricating layer on the surface of the medical device. (5) The surface of the base material of the medical device is impregnated with a polymer solution in which a hydrophilic polymer having a reactive functional group in its molecule is dissolved in a solvent, and subsequently a functional group capable of reacting with the reactive functional group is added. A medical device having a surface having lubricity when wet, characterized in that the surface of the substrate is impregnated with a polymer solution prepared by dissolving a polymer having a solvent in the solvent, and further insolubilized to form a surface lubricating layer on the surface of the medical device. Production method. (6) The method for producing a medical device according to (4) or (5), wherein the surface lubricating layer contains an antithrombotic agent, the surface of which has lubricity when wet.

In the present invention, the hydrophilic polymer having a reactive functional group means that it has an epoxy group, an acid chloride group, an aldehyde group, etc. in the molecule as a reactive functional group and contains 1% of water.
The above is a polymer compound that absorbs water. The expression of surface lubricity occurs when the hydrophilic polymer absorbs an aqueous solvent such as physiological saline, a buffer solution, or blood. That is, it is considered that water existing on the material surface develops a lubricating function by fluid lubrication at the interface in contact with the blood vessel wall. Therefore, the hydrophilic polymer of the present invention has a water absorption of 100 wt% in the temperature range (usually 30 to 40 ° C.) used.
% Or more is preferable for achieving lubricity.

The method for producing a hydrophilic polymer having a reactive functional group can be obtained by copolymerizing a monomer having a reactive functional group in the molecule with a hydrophilic monomer. A block or graft copolymer in which monomers having a reactive functional group are aggregated to form a reactive domain and hydrophilic monomers are aggregated to form a hydrophilic domain is preferable. When it is a block or graft copolymer, good results are obtained in the strength and lubricity of the surface hydrogel layer.

As the monomer having a reactive functional group, a monomer having a reactive heterocycle such as glycidyl acrylate or glycidyl methacrylate in the molecule and an acid chloride such as acrylic acid chloride or methacrylic acid chloride in the molecule. Examples of the monomer include a monomer having an isocyanate group such as acryloyloxyethyl isocyanate in the molecule. A preferable reactive monomer is glycidyl acrylate or glycidyl methacrylate whose reactive group is an epoxy group, whose reaction is accelerated by heat or the like, and whose handling is relatively easy.

Examples of the hydrophilic monomer include acrylamide and its derivatives, vinylpyrrolidone, acrylic acid, methacrylic acid and their derivatives, and polymers having a water-soluble monomer as a main constituent. For example, N-methylacrylamide, N, N-dimethylacrylamide, acrylamide, acryloylmorpholine, N, N-dimethylaminoethyl acrylate, vinylpyrrolidone, 2-methacryloyloxyethylphosphorylcholine, 2-methacryloyloxyethyl-D-glycoside. , 2-methacryloyloxyethyl-D-mannoside, vinyl methyl ether and the like can be preferably exemplified, but not limited thereto.

Further, as a base material for medical devices, a relatively hydrophobic polymer is often used in view of physical properties and moldability. Therefore, a base material made of such a material is swollen to obtain a hydrophilic polymer. An organic solvent is often used to impregnate the. Therefore, the hydrophilic polymer having a reactive group needs to be a polymer soluble in an organic solvent such as tetrahydrofuran or an amphipathic polymer.

In the present invention, a polymer having a functional group capable of reacting with a reactive functional group means a functional group capable of reacting with the above-mentioned reactive functional group, for example, a carboxyl group, a hydroxyl group, an amino group, an anhydrous carboxylic group. It is a polymer or copolymer containing a monomer having an acid, a thiol group or the like as a constituent component. Examples thereof include polyethyleneimine, polyacrylic acid, polymethacrylic acid, polyallylamine, polylysine, polyvinyl alcohol, ethylene-vinyl alcohol copolymer, and copolymers thereof. The monomer to be copolymerized does not have to react with the reactive functional group, and examples thereof include acrylamide derivatives, (meth) acrylic acid esters, and monomers having phospholipids or sugars in the molecule. In addition, 2-acrylamide-2-
A preferable example is a copolymer of a polysulfate compound such as methylpropanesulfonic acid and sulfoalkyl acrylates with a polymer compound that exhibits anticoagulant activity (heparin-like activity, antithrombin activity).

In the present invention, two kinds of polymers, a hydrophilic polymer having a reactive functional group in the molecule and a polymer having a functional group capable of reacting with the reactive functional group, are dissolved in a solvent to obtain a high mixing ratio. After preparing a molecular solution and impregnating the surface of the base material of the medical device with this mixed polymer solution, two kinds of polymers react with each other to form a crosslinked structure and become insoluble. When it comes into contact with body fluid or physiological saline, it absorbs water and forms a hydrogel layer on the surface. This hydrogel layer serves as a "surface lubrication layer" for avoiding direct contact between the surface of the medical device and living tissue, and reduces friction. In addition, the two types of polymers that react with each other may be dissolved in a solvent separately in each solvent and mixed immediately before use, or after the mixed solution is prepared, the reaction is difficult to proceed until use ( It may be stored at low temperature). In addition, when there is no suitable solvent for dissolving the two kinds of polymers, the solvent may be changed to separately impregnate the surface of the base material of the medical device. However, in order to form a strong surface lubricating layer, it is important to carry out the reaction with the polymer solution sufficiently impregnated in the substrate.

When the reactive functional group of the hydrophilic polymer is an epoxy group, heat treatment at 40 ° C. or higher, preferably 50 ° C. or higher, more preferably 60 ° C. or higher facilitates the cross-linking structure. Can be formed and insolubilized. The heat treatment is not only a cross-linking reaction between two types of polymers, but also a cross-linking reaction within a hydrophilic polymer, and further when the surface of the base material of the medical device has a functional group capable of reacting with an epoxy group. It also promotes reaction with. That is, the cross-linking reaction is difficult to proceed with a polymer having an epoxy group in the molecule alone, but by allowing a polymer having a hydroxy group or an amino group to coexist, the cross-linking reaction can be promoted to form a strong surface lubricating layer. It will be possible. In order to accelerate the reaction, a catalyst may be added in addition to heat. For example, for an epoxy group, a trialkylamine compound or a tertiary amine compound such as pyridine is preferably used. Light, electron beam, radiation or the like may be used to accelerate the reaction.

Further, it is possible to further increase the crosslinked structure subsequent to the above reaction. That is, by forming a small amount of the three-dimensional network structure, the strength of the surface lubricating layer can be further increased without significantly lowering the lubricity. However, if there are too many crosslinked structures,
Since the water swelling property decreases and the low friction property of the surface is impaired,
Care must be taken in the formation of crosslinks. Various general methods can be applied as the method of crosslinking. For example,
By using light, heat, or radiation to generate active radicals to crosslink the polymer, adding a polymerizable polyfunctional monomer in addition to it, applying a polyfunctional crosslinking agent, or using a catalyst And a method of crosslinking functional groups in the molecule with each other. Examples thereof include polyamino compounds, polyhydroxy compounds, polyaldehyde compounds and the like.

Since the epoxy group reacts with a hydroxy group, an amino group, etc., the copolymerization of the monomer having an epoxy group in the molecule with the monomer having a hydroxy group, a carboxyl group, an amino group, etc. Coalescence is difficult to synthesize because it reacts and insolubilizes in the molecule. However,
As in the present invention, a polymer having a carboxyl group or an amino group and a polymer having an epoxy group are separately prepared and applied to the surface of the base material to introduce a structure having a charge on the surface. And using these functional groups, the antithrombotic agent described below is adsorbed by electrostatic interaction,
It is also possible to fix it to the surface lubricating layer of the medical device or to release it slowly. Of course, the anti-thrombotic agent can be impregnated into the surface lubricating layer and sustained release without depending on the electrostatic interaction.

The base material of the medical device is not particularly limited. It may be metal, ceramic, organic material, or composite material. However, it is preferable that the organic polymer compound is present on the surface of the base material. It may be a base material molded and processed with the polymer alone, or may be a base material that is molded and processed by alloying and is present on the surface of the base material. Examples of organic materials include polyolefins, modified polyolefins, polyethers, polyurethanes, polyamides, polyimides, polyesters and copolymers thereof.

For the purpose of improving the antithrombotic property, the surface lubricating layer may carry an antithrombotic agent or may be gradually released.
The antithrombotic agent may be any agent that suppresses thrombus formation or a substance that dissolves the generated thrombus, such as an anticoagulant agent, an antiplatelet agent,
Examples include natural and synthetic substances represented by fibrinolysis promoters. Such substances include heparin, low molecular weight heparin, dermatan sulfate, heparan sulfate, activated protein C, hirudin, aspirin, thrombomodulin, DHG, plasminogen activator, streptokinase, urokinase, aprotinin, nafamostat mesylate ( Examples thereof include various coagulation protease inhibitors such as FUT) and gabexate mesylate (FOY), but are not limited thereto.

As a method for applying the antithrombotic agent to the substrate of the medical device, a solution in which the polymer forming the surface lubricating layer and the antithrombotic agent coexist may be used, or the surface lubricating layer may be applied. The solution containing the polymer to be formed and the solution containing the antithrombotic agent may be separately applied. To the solution containing the antithrombotic agent, by adding a substance other than the antithrombotic agent, for example, a polymer compound having good adhesion to the substrate, the coating state on the surface can be improved or the antithrombotic agent Controlled release is performed. By applying a polymer solution containing the polymer that forms the surface lubricating layer and the antithrombotic agent to the surface of the base material, a surface that has both antithrombotic properties and surface lubricity is formed, and the antithrombotic agent is gradually released from the surface. You can also let it. Further, a surface having both antithrombogenicity and surface lubricity can be produced by applying an antithrombotic agent to the surface of the base material of the medical device and then forming a surface lubrication layer.

The frictional resistance as an index of surface lubricity can be measured by preparing a sheet having a surface similar to that of a medical device and measuring with a measuring instrument as shown in FIG. It can be evaluated by rubbing with. The surface lubricating layer is characterized by having a slippery feel like eel, and the coefficient of static friction determined using polyethylene as the contact surface is 0.15 or less.

[0024] As medical devices which are required to have surface lubricity or antithrombogenicity, catheters and guide wires used especially in blood vessels can be preferably exemplified, but the following medical devices can be exemplified. (1) Catheter such as a gastric tube catheter, feeding catheter, tube feeding (ED) tube and the like, which are orally or nasally inserted or left in the digestive tract. (2) oxygen catheter, oxygen canula, endotracheal tube tube or cuff, tracheostomy tube tube or cuff,
Catheter such as intratracheal suction catheter that is inserted or placed in the airway or trachea orally or nasally. (3) Catheter such as catheter of urethral catheter, urinary catheter, balloon catheter, etc. inserted or left in urethra or ureter such as balloon (4) Various body cavities, organs, tissues such as suction catheter, drainage catheter, rectal catheter Catheter to be inserted or placed in the. (5) Indwelling needles, IVH catheters, thermodilution catheters, angiographic catheters, vascular dilatation catheters and dilators or introducers, catheters that are inserted or left in the blood vessels such as stents. Alternatively, guide wires, stylets, balloons, etc. for these catheters. (6) Inspection and treatment instruments for inserting various organs, contact lenses, etc. (7) Artificial organs such as artificial heart, artificial lung, artificial kidney, artificial liver, and artificial blood vessels, and their circuits.

[0025]

EXAMPLES The present invention will be specifically described with reference to the following examples. Example 1 50 ° C. in 72.3 g of adipic acid dichloride
Then, after adding 29.7 g of triethylene glycol, 5
4.5 g of methyl ethyl ketone was added to 22.5 g of oligoester obtained by removing hydrochloric acid under reduced pressure at 0 ° C. for 3 hours, 5 g of sodium hydroxide, 6.93 g of 31% hydrogen peroxide, 0.44 g of dioctyl phosphate surfactant, Water 120
It was dropped into a solution of g and reacted at -5 ° C for 20 minutes. The obtained product was repeatedly washed with water and washed with methanol and then dried to obtain a polyperoxide having a plurality of peroxide groups in the molecule (PPO). Subsequently, 0.5 g of this PPO as a polymerization initiator and 9.5 g of glycidyl methacrylate (GMA) were polymerized using 30 g of benzene as a solvent at 65 ° C. for 2 hours under reduced pressure with stirring. The reaction product was reprecipitated with diethyl ether to obtain poly-GMA having a peroxide group in the molecule. continue,
1 g of this poly-GMA was used as a polymerization initiator, and 8 g of dimethyl acrylamide (DMAA) was used as a DM as a hydrophilic monomer.
By charging in SO and polymerizing at 70 ° C. for 18 hours, a block copolymer (B1) having poly GMA as a reactive domain and poly DMAA as a water-swelling hydrophilic domain was obtained. The composition (molar ratio) of B1 is ¹ H-N
When analyzed by MR, DMAA: GMA = 7.1: 1
Met. In the same manner, using hydroxyethyl methacrylate (HEMA) instead of GMA, the block polymer (B2) (DMAA: HEMA (molar ratio) =
6.4: 1) was obtained.

After adjusting each 3 wt% THF solution (containing 1 wt% of pyridine) of the block polymers (B1) and (B2), both polymer solutions were mixed at a ratio of 1: 1 (weight ratio), and this mixed solution was prepared. The outer diameter made of polyurethane is 5
After immersing the Fr (1.65 mm) tube, dry it,
Then, the mixture was reacted in an oven at 60 ° C. for 18 hours. When the tube was dipped in saline and rubbed with a finger, it had a low-friction surface that was slippery compared to the untreated tube.

Example 2 The block polymer polymers (B1) and (B2) used in Example 1 were dissolved in 1 wt% each and chloroform (containing 1 wt% pyridine) to prepare ethylene-acrylic acid ester-maleic anhydride. Terpolymer (Sumitika CDF: Bondine TX803
A sheet (200 μ) consisting of 0) was dipped at 25 ° C. for 1 minute, dried, and further reacted in an oven at 60 ° C. for 18 hours to prepare a sample. The surface of the obtained sheet is
It became a slimy hydrogel when wet and had excellent lubricity. Further, the surface lubricity was evaluated by the test method shown in FIG.

(Surface lubricity test method) An evaluation sheet (4) in which a brass cylindrical weight (2) weighing 1 kg in water (1) was adhered to a slanted plastic plate (at an angle of 30 degrees) Gently place it on the top and move it up and down 100 cm / min at a speed of 1 cm repeatedly 100 times.
The change in the frictional resistance value at that time was evaluated. The final frictional resistance value after 100 tests was calculated as an index of surface lubricity, and the change in frictional resistance value (Δ frictional resistance value) of the following formula (A) was calculated as a continuous index of lubricity.

Δ friction resistance value = (final friction resistance value) − (initial friction resistance value) (A)

As a result of the test, the final friction resistance value is 74 gf.
And the Δ frictional resistance value is 10 gf or less, which is 1
Stable low frictional properties were shown even in the movement test of 00 times. As a result of observing the surface and the cross section of the sheet with a scanning electron microscope (JEOL JSM840), there was no change before and after the test, and it was confirmed that the surface lubricating layer was stably bonded without peeling.

Comparative Examples 1 and 2 Example 1 as Comparative Example 1
The untreated sheet of Comparative Example 2 and the sheet of Comparative Example 2 reacted with the THF solution in which only the block polymer (B2) of Example 1 was dissolved were tested in the same manner as in Example 1, and the friction resistance value was determined. Is the initial frictional resistance value of 250 gf, Δ
The frictional resistance value is 15 gf and the surface is not excellent in lubricity, and Comparative Example 2 has an initial frictional resistance value of 92 gf and a Δ frictional resistance value of 11
At 0 gf, the durability of the surface lubricating layer was poor.

(Example 3) E which is a protease inhibitor
thyl p- (6-guanidinohexanoyl) benzoate methanesulfo
1 containing 1 wt% of nate (ethyl p- (6-guanidinohexanoyl) benzoate methanesulfonate)
0 wt% polyurethane (Puresen 65 manufactured by DuPont)
D) The dimethylformamide solution was applied to a polyurethane catheter having an outer diameter of 5 Fr to prepare an antithrombotic surface having a function of inhibiting activation of the blood coagulation system and inhibiting platelet aggregation by inhibiting thrombin or the like. Then, in the same manner as in Example 1, it was immersed in a mixed solution of block polymers (B1) and (B2), dried, and further reacted at 60 ° C. for 18 hours to prepare a catheter having a lubricious surface. When water was dropped on the surface of the catheter and the lubricity was examined, it was found to be a slimy, low-friction surface. 2 at your fingertips
Even if it was rubbed strongly about 0 times, the lubricity was not lost.

As a test for antithrombogenicity, the catheter was cut into 30 cm and the tip was immersed in fresh human blood. When the state of the thrombus formed on the surface of the catheter was observed after 5 minutes, no thrombus was formed on the surface. However, thrombus adhesion was observed on the surface of the untreated polyurethane catheter for comparison and control.

Example 4 A guide wire was prepared by coating polyurethane (Tecoflex EG-100A-V manufactured by Thermedix Co., Ltd.) with a resin in which 50 wt% of tungsten was kneaded as a sensitizer. Further, as a polymer solution, a block copolymer of dimethyl acrylamide and glycidyl methacrylate (molar ratio = 6.8: 1) and random of methacrylic acid and 2-methacryloyloxyethylphosphorylcholine (molar ratio = 1: 4). Copolymer
A THF solution (containing 1 wt% of pyridine) dissolved in a proportion of 2 wt% and 1 wt%, respectively, was prepared, and the guide wire was immersed at 25 ° C. for 30 seconds, dried, and reacted in an oven at 60 ° C. for 40 hours. When the guide wire was immersed in physiological saline and rubbed with a finger, it had a low-friction surface that was slippery as compared with the untreated guide wire.
Further, no thrombus adhesion was observed even after soaking in human fresh blood for 5 minutes.

Example 5 Using the guide wire of Example 4 as a polymer solution, a block copolymer of dimethylacrylamide and glycidyl methacrylate (molar ratio = 6.8: 1) and polyethyleneimine (molecular weight 400) were used.
A THF solution (containing 1 wt% of pyridine) in which 0) was dissolved in a proportion of 2 wt% and 0.5 wt% respectively was prepared, and the guide wire was dipped at 25 ° C. for 30 seconds and then dried.
The reaction was carried out in an oven at 0 ° C for 40 hours. Subsequently, the surface was immersed in a phosphate buffer containing 0.2 wt% of heparin for 2 minutes, washed with water, and dried to prepare a heparin-immobilized surface. The guide wire was not observed to have thrombus attached even after being immersed in fresh human blood for 5 minutes.

Example 6 The polyurethane tube of Example 1 was prepared by using a 2 wt% methyl chloride solution (containing 1 wt% of pyridine) of the block polymer (molar ratio DMAA: GMA = 7.1: 1) used in Example 1. ) For 30 seconds,
It was dried at 60 ° C. for 2 minutes. Then, a block polymer of 2-acrylamido-2-methylpropanesulfonic acid (AMPS) and acrylic acid (AA) (the molar ratio is AMP).
2% by weight aqueous solution of S: AA = 5: 1 (1w of pyridine
(containing t%) for 2 minutes, dried at 60 ° C. for 18 hours and reacted. When the tube was dipped in saline and rubbed with a finger, it had a low-friction surface that was slippery compared to the untreated tube. Further, no thrombus adhesion was observed even after soaking in human fresh blood for 5 minutes.

[0037]

The surface lubricating layer of the present invention is a method of impregnating the surface of a base material with two types of polymers that react with each other at the same time, and reacting the reactive groups of the two types of polymers with each other. The hydrogel layer can be formed on the surface of the substrate by various operations. Further, it becomes possible to prepare a surface having a dissociative group such as a carboxyl group, an amino group, a sulfonic acid group, etc., and the electrostatic interaction of the functional group (dissociative group) makes it easy to fix the antithrombotic agent on the surface. It also becomes possible to release and gradually release.

Further, since the surface lubrication layer is bonded between the polymers or between the base material and the polymer due to the cross-linking structure, the desorption of the lubricant found in the method of applying the lubricant such as silicone oil or glycerin. The phenomenon of leaching and elution was not observed, and a surface lubricating layer having high safety and durability was formed.

[Brief description of drawings]

FIG. 1 is an explanatory diagram of a test method for evaluating surface lubricity according to the present invention.

[Explanation of symbols]

 1 Water 2 Brass cylindrical weight 3 Polyethylene sheet 4 Sample

Claims (6)

[Claims] 1. An insolubilized product comprising a hydrophilic polymer having a reactive functional group in the molecule and a polymer having a functional group capable of reacting with the reactive functional group is bonded to the surface of a base material of a medical device to form a surface. A medical device having a lubricating property on its surface when wet, characterized by having a lubricating layer formed. 2. The medical device according to claim 1, wherein the reactive functional group of the hydrophilic polymer is an epoxy group, the surface of which has lubricity when wet. 3. The medical device according to claim 1, wherein the surface lubricating layer contains an antithrombotic agent, the surface of which has lubricity when wet. 4. A polymer solution prepared by dissolving a mixture of a hydrophilic polymer having a reactive functional group in its molecule and a polymer having a functional group capable of reacting with the reactive functional group in a solvent, to prepare a medical device. A method for producing a medical device having a surface having lubricity when wet, comprising impregnating the surface of a base material, further insolubilizing the surface, and forming a surface lubricating layer on the surface of the medical device. 5. A functional group capable of reacting with a reactive functional group by impregnating the surface of a substrate of a medical device with a polymer solution prepared by dissolving a hydrophilic polymer having a reactive functional group in the molecule in a solvent. The surface has lubricity when wet, which is characterized in that the surface of the substrate is impregnated with a polymer solution prepared by dissolving a polymer having a group in a solvent and further insolubilized to form a surface lubricating layer on the surface of the medical device. Method for manufacturing medical device. 6. The method for manufacturing a medical device according to claim 4, wherein the surface lubricating layer contains an antithrombotic agent, and the surface has lubricity when wet.