JP6395252B2 - Medical device material, and medical device, antithrombotic material and cell culture substrate using the same - Google Patents

Description

The present invention relates to a medical device material. More specifically, the present invention relates to a medical device material suitable as a material for a medical device used in contact with a biological component or biological tissue.

High molecular compounds can be designed with various characteristics by selecting monomers as raw materials, and are widely used in various applications from industrial products to daily necessities. One of the uses of such a polymer compound is a medical device. Medical devices are used in an environment where they come into contact with biological components or biological tissues such as blood, and when the surface of the medical devices is low in affinity with biological components or biological tissues, the biological defense mechanism is activated and blood coagulates. This causes problems such as the formation of blood clots. For this reason, at least the surface which contacts a biological component or a biological tissue needs to be formed from a highly biocompatible material for the medical device.

In order for a polymer compound to be a highly biocompatible material that can be used in the medical field, the state of water present on the polymer compound surface when the polymer compound is hydrated is considered important. Yes. In general, when water is hydrated to a polymer compound, the surface of the polymer compound has a strong interaction with the polymer compound and does not freeze (antifreeze water). There is free water that exists away from the surface and weakly interacts with the polymer compound, but in some polymer compounds, there is a polymer compound or antifreeze water between the antifreeze water and the free water. It has become clear that some have water (intermediate water) that interacts with them. Biological components and biological tissues are stable by forming hydration shells in blood and body fluids, and when these hydration shells are disturbed or destroyed by contact with the surface of foreign matter or antifreeze water, It is thought that the tissue is adsorbed on the surface of the polymer material and the biological defense mechanism is activated, but the intermediate water is stably present on the antifreeze layer on the surface of the polymer material, so It has become clear that protein and cell surface hydration structures are less likely to be destroyed even when they come into contact with tissue, and that this makes polymer compounds highly biocompatible. (Refer nonpatent literature 1-3.). That is, it is widely recognized that the presence or absence of intermediate water is essential for the expression of biocompatibility.

As a polymer material used in such a medical field, the equilibrium moisture content at the time of moisture content is a predetermined value, and an exothermic peak based on low-temperature crystallization of water at 0 ° C. or less in a temperature rising process in differential scanning calorimetry measurement. A water-insoluble blood compatible polymer (see Patent Document 1) having a glass transition temperature of 0 ° C. or lower is disclosed, and cells having similar characteristics are required. As a culture substrate, a cell culture substrate (see Patent Document 2) containing a gel formed of hyaluronic acid alone that is hardly soluble in a neutral aqueous solution is disclosed. Furthermore, the frequency of cell adsorption on the surface of the substance changes depending on the state of the water layer on the surface of the substance, and the frequency of adsorption varies depending on the type of cell, and this is used to select specific cells. A cell separation method (see Patent Document 3) in which the sample is adsorbed and separated from the solution is disclosed.

JP 2004-161954 A JP 2000-239304 A JP 2012-105579 A

Kobunshi Ronbunshu, Vol. 68, no. 4, pp. 133-146, (Apr., 2011) Kobunshi Ronbunshu, Vol. 60, no. 8, pp. 415-427, (Aug., 2003) Polymer, 53, March, 2004, pp. 157

As described above, research reports have been made on the relationship between highly biocompatible materials and intermediate water, and biocompatible materials and the like are being actively developed.
The demand for materials with high biocompatibility that can be used for medical devices is high, and if new materials containing such intermediate water can be developed, selection of polymer materials that can be used for medical devices, etc. This is also preferable from the viewpoint that it can expand the range of medical treatment and contribute to the future development of medical care.

This invention is made | formed in view of the said present condition, and aims at providing the material for medical devices containing the new high molecular compound which has intermediate water at the time of hydration.

As a result of various studies on new polymer compounds having intermediate water during hydration, the present inventors have found that a polymer having a structure derived from an acrylic acid derivative having a predetermined structure having two carboxyl groups or salts thereof in the structure. It has been found that the present invention can be used as a medical device material having intermediate water at the time of hydration and having biocompatibility.
Here, the biocompatibility in the present invention does not give a strong adverse effect or a strong stimulus to a living body, and therefore has an attribute that can coexist with any one or more of a biological component, a biological tissue and a biological substance. means. For example, biocompatible materials typically have anti-thrombogenic properties that inhibit thrombus formation, anti-blood coagulation properties that inhibit blood coagulation, and properties that make complements difficult to activate. It has one or more properties such as a property that it is difficult to reduce leukocytes, a property that it is difficult to cause inflammation in living tissue, and a property that it is difficult to form a tumor.

That is, the present invention provides the following formula (1);

(Wherein n represents a number from 0 to 2. X and Y each independently represent a hydrogen atom, an alkali metal atom, or an ammonium group). It is the material for medical devices characterized by including the polymer which has.
The present invention is described in detail below.
A combination of two or more preferred embodiments of the present invention described below is also a preferred embodiment of the present invention.

The polymer having a structural unit derived from the monomer represented by the formula (1) has two carboxyl groups or salts thereof in the structure, and a plurality of carboxyl groups or salts thereof are contained in such a structure. A polymer having a large amount of intermediate water has not been known so far.
Although it is not clear about the mechanism by which the polymer having the structure of the present invention retains intermediate water, it is caused by the fact that the two carboxyl groups have an appropriate spatial arrangement, so that strong hydration to carbonyl oxygen is weakened. I think that.
Further, this polymer is also characterized by being able to adsorb a relatively large amount of intermediate water relative to the amount of antifreeze water.
The medical device material of the present invention may contain other materials as long as it contains a polymer having a structural unit derived from the monomer represented by the above formula (1).
Moreover, 1 type of the polymer which has a structural unit derived from the monomer represented by the said Formula (1) may be included, and 2 or more types may be included.
The structural unit derived from the monomer represented by the formula (1) is a structural unit in which the carbon-carbon double bond of the monomer represented by the formula (1) is a single bond. Specifically, it can be represented by the following formula (2). In addition, if the structural unit derived from the monomer represented by the above formula (1) is a structure represented by the following formula (2), other than polymerizing the monomer represented by the formula (1) It may be a structural unit formed by a method.

(In Formula (2), n, X, and Y are the same as Formula (1).)

In the formula (1), X and Y each independently represent a hydrogen atom, an alkali metal atom, or an ammonium group, and the alkali metal atom is preferably sodium or potassium. More preferably, it is sodium.
In said formula (1), although n represents the number of 0-2, Preferably it is 1 or 2. More preferably 2.

The polymer having a structural unit derived from the monomer represented by the formula (1) may be a polymer obtained using only the monomer represented by the formula (1) as a raw material. ) And a copolymer obtained by using a monomer component containing another monomer as a raw material.
When the polymer having a structural unit derived from the monomer represented by the formula (1) is a copolymer, it may be in any form of random polymerization, block polymerization, and alternating polymerization.

The polymer having the structural unit derived from the monomer represented by the formula (1) is a structural unit derived from the monomer represented by the formula (1) with respect to 100% by mass of all the monomer units. It is preferable to have 10-100 mass%. By containing in such a ratio, the obtained polymer becomes more suitable as a medical device material. More preferably, it is having 20-100 mass% of structural units derived from the monomer represented by the above formula (1), and more preferably 30-100 mass%.

When the polymer having the structural unit derived from the monomer represented by the formula (1) has other structural units other than the structural unit derived from the monomer represented by the formula (1), the other As the monomer for forming the structural unit, methyl (meth) acrylate, ethyl (meth) acrylate, n-propyl (meth) acrylate, i-propyl (meth) acrylate, (meth) acrylate n -Butyl, s-butyl (meth) acrylate, t-butyl (meth) acrylate, n-amyl (meth) acrylate, s-amyl (meth) acrylate, t-amyl (meth) acrylate, (meta ) N-hexyl acrylate, 2-ethylhexyl (meth) acrylate, isodecyl (meth) acrylate, tridecyl (meth) acrylate, cyclohexyl (meth) acrylate, (meth) acrylic acid Hexylmethyl, octyl (meth) acrylate, lauryl (meth) acrylate, stearyl (meth) acrylate, benzyl (meth) acrylate, phenyl (meth) acrylate, isobornyl (meth) acrylate, (meth) acrylic acid Adamantyl, tricyclodecanyl (meth) acrylate, 2-hydroxyethyl (meth) acrylate, 2-hydroxypropyl (meth) acrylate, 3-hydroxypropyl (meth) acrylate, 2-hydroxy (meth) acrylate Butyl, 3-hydroxybutyl (meth) acrylate, 4-hydroxybutyl (meth) acrylate, 2-methoxyethyl (meth) acrylate, 2-ethoxyethyl (meth) acrylate, phenoxyethyl (meth) acrylate, (Meth) acrylic acid tetrahydrofurfuryl, (meta Glycidyl acrylate, β-methylglycidyl (meth) acrylate, β-ethylglycidyl (meth) acrylate, methyl (meth) acrylate (3,4-epoxycyclohexyl), N, N-dimethylamino (meth) acrylate (Meth) acrylic acid esters such as ethyl, methyl α-hydroxymethyl acrylate, ethyl α-hydroxymethyl acrylate; styrene, α-methyl styrene, α-chlorostyrene, pt-butyl styrene, p-methyl styrene , P-chlorostyrene, o-chlorostyrene, 2,5-dichlorostyrene, 3,4-dichlorostyrene, vinyltoluene, methoxystyrene, and other aromatic vinyls; methylmaleimide, ethylmaleimide, isopropylmaleimide, cyclohexylmaleimide, phenyl Maleimide, benzyl N-substituted maleimides such as maleimide and naphthylmaleimide are exemplified. These other copolymerizable monomers can be used alone or in combination of two or more. Among these, (meth) acrylic acid esters are preferable. (Meth) acrylic acid alkyl ester is more preferred, (meth) acrylic acid alkyl ester having 1 to 8 carbon atoms in the alkyl ester alkyl group is more preferred, and (meth) acrylic acid is particularly preferred. n-Butyl.

The polymer having a structural unit derived from the monomer represented by the above formula (1) preferably has a weight average molecular weight of 1,000 to 1,000,000. When the weight average molecular weight is in such a range, a material excellent in durability and mechanical strength is preferable. The weight average molecular weight is more preferably 5,000 to 500,000, and still more preferably 10,000 to 300,000.
The weight average molecular weight of the polymer can be measured by gel permeation chromatography (GPC) under the measurement conditions described in the examples.

The polymer having a monomer-derived structural unit represented by the above formula (1) preferably has a glass transition temperature of 40 to 200 ° C. When the polymer has such a glass transition temperature, surface stickiness can be suppressed. The glass transition temperature is more preferably 50 to 170 ° C, and still more preferably 60 to 150 ° C.
The glass transition temperature can be measured by differential scanning calorimetry (DSC).

The polymer having a structural unit derived from the monomer represented by the above formula (1) preferably has an intermediate water amount of 1% by mass or more with respect to 100% by mass of the polymer. The amount of intermediate water is more preferably 2% by mass or more, and further preferably 3% by mass or more. By setting the amount of intermediate water in the above range, adsorption of small floating cells such as platelets and plasma proteins can be effectively avoided. The upper limit of the amount of intermediate water varies depending on the purpose for which the medical device material is used, so it cannot be described in general. For example, the purpose of selectively adsorbing cancer cells and hepatocytes without alteration When it is used in the above, it is preferably 30% by mass or less.

In general, the material for medical devices is preferably a material that can hold water with a large ratio of the intermediate water amount to the antifreeze water amount (intermediate water amount / antifreeze water amount), and is simply expressed by the above formula (1). Even in a polymer having a structural unit derived from a monomer, it is preferable that the intermediate water amount (intermediate water amount / antifreeze water amount) with respect to the antifreeze water amount can be 0.1 or more. Moreover, it is more preferable that it can be 0.2 or more.
Once the polymer containing a predetermined amount of water has been sufficiently cooled, heat absorption and heat generation are observed while raising the temperature at a slow rate, and heat generation is observed in a specific temperature range of 0 ° C. or less. An endotherm is observed at a temperature around 0 ° C. Heat generation in a specific temperature range of 0 ° C. or lower is considered to be due to the fact that the intermediate water solidified in a metastable state due to supercooling causes ordering (cold crystallization) by heating. Of the endotherm at temperatures near 0 ° C., the endotherm in the temperature range below 0 ° C. is due to low-temperature melting of the intermediate water, and the endotherm at 0 ° C. is due to melting of free water. Accordingly, the amount of heat generated at a specific temperature range of 0 ° C. or lower, the amount of heat absorbed at a temperature near 0 ° C., and the amount of intermediate water, free water, and antifreeze water can be determined from the total water content.
The presence of intermediate water, and the amount of intermediate water and antifreeze water can be confirmed by the method described in Examples using differential scanning calorimetry (DSC) measurement.

The polymer contained in the medical device material of the present invention is a polymerization reaction using a monomer component containing the monomer represented by the above formula (1) and, if necessary, another monomer as a raw material. Can be manufactured.
The polymerization reaction is preferably performed in the presence of a polymerization initiator. Examples of the polymerization initiator include hydrogen peroxide; persulfates such as sodium persulfate, potassium persulfate, and ammonium persulfate; dimethyl 2,2′-azobis (2-methylpropionate), 2,2′-azobis. Preferred are azo compounds such as (isobutyronitrile); organic peroxides such as benzoyl peroxide, peracetic acid, and di-t-butyl peroxide. These polymerization initiators may be used alone or in the form of a mixture of two or more.
The amount of the polymerization initiator used is preferably 0.1 g or more and 25 g or less, more preferably 0.1 g or more and 10 g or less with respect to 1 mol of the monomer used.

The polymerization reaction may be performed without using a solvent, but it is preferable to use a solvent. Solvents include water; lower alcohols such as methanol, ethanol and isopropyl alcohol; lower ketones such as acetone, methyl ethyl ketone and diethyl ketone; ethers such as dimethyl ether and dioxane; amides such as dimethylformaldehyde; ethyl acetate and butyl acetate Lower esters such as toluene; aromatics such as toluene and xylene. These solvents may be used alone or in the form of a mixture of two or more.
As a usage-amount of a solvent, 40-250 mass% is preferable with respect to 100 mass% of monomers.

The polymerization reaction is usually preferably carried out at 0 ° C. or higher, and is preferably carried out at 150 ° C. or lower. More preferably, it is 40 degreeC or more, More preferably, it is 60 degreeC or more, Most preferably, it is 80 degreeC or more. Moreover, More preferably, it is 120 degrees C or less, More preferably, it is 110 degrees C or less. The polymerization temperature does not always need to be kept substantially constant in the polymerization reaction, and may vary (warming or cooling) once or twice or more.

The method for producing a polymer contained in the medical device material of the present invention may include a step other than the polymerization reaction step. For example, an aging step, a neutralization step, a deactivation step of a polymerization initiator or a chain transfer agent, a dilution step, a drying step, a concentration step, a purification step, and the like can be mentioned.
Further, instead of the polymerization reaction step, for example, after the step of polymerizing an ester of the monomer represented by the above formula (1) and other monomers as necessary, the obtained polymer is hydrolyzed. The polymer contained in the medical device material of the present invention may be produced by decomposing.

The medical device material of the present invention contains a polymer containing intermediate water as described above, and has high affinity with biological components and tissues, so that it does not easily cause thrombus even when it comes into contact with blood. It can be suitably used as an antithrombotic material, and can also be suitably used as a material constituting a part that comes into contact with a biological component or biological tissue of various medical devices. Furthermore, the medical device material of the present invention can be suitably used as a cell culture substrate.
Such a medical device using the medical device material of the present invention, the medical device also includes a medical device in which a portion in contact with a biological component or a biological tissue is configured using the medical device material. In addition, an antithrombotic material and a cell culture substrate that are one of the present invention and use the material for a medical device of the present invention are also one of the present invention.
The medical device using the medical device material of the present invention has a surface treatment of the portion of the medical device that comes into contact with a biological component or biological tissue with the medical device material of the present invention, and holds the medical device material of the present invention. It can be manufactured using a method. Thus, the medical device material of the present invention can be used as a surface treatment agent for medical devices.

Examples of a method for holding the medical device material of the present invention in a portion that comes into contact with a biological component or biological tissue of various medical devices include a method of coating the surface of the medical device with the medical device material, radiation, electron beam, ultraviolet light, etc. Various methods such as a method of bonding the surface of a medical device and a material for a medical device using graft polymerization by active energy rays, a method of bonding a functional group on the surface of a medical device and a material for a medical device, etc. Can be used. When the coating method is used, any method such as an application method, a spray method, or a dip method may be used as a method for coating a medical device material.

The material of the medical device for holding the medical device material of the present invention is not particularly limited, and polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, polyvinylidene fluoride, polytetrafluoroethylene, halogenated polyolefin, polyethylene terephthalate, polycarbonate, Any material such as polyamide, acrylic resin, and styrene resin may be used.

When the medical device material of the present invention is used as a cell culture substrate, the medical device material may be used as it is, or may be coated on a predetermined substrate.
The material of the substrate is not particularly limited, and natural polymers such as cotton and hemp, synthetic polymers such as polyester, nylon, olefin, polyamide, polyurethane, polyacrylonitrile, and poly (meth) acrylate can be used.
The form of the substrate is not particularly limited, and may be any form such as a molded body, fiber, nonwoven fabric, porous body, particle, film, sheet, tube, hollow fiber, and powder.

The medical device material of the present invention is used for artificial biological tissues such as artificial blood vessels and artificial organs, blood filters, various catheters, various stents, etc .; as a member for tools that come into contact with biological tissues, and as a cell culture substrate It can be applied as a member for tools that come into contact with components derived from living organisms (cells, blood, etc.);
That is, the medical tool in the present invention includes a tool that comes into contact with a living tissue, a tool that comes into contact with a biological component (cell, blood, etc.), and the like.
That is, the material for a medical device in the present invention refers to a material used for a medical device, a cell culture substrate, or an antithrombotic material that comes into contact with a biological tissue or a biological component (cell, blood, etc.).

The medical device material of the present invention has the above-described configuration and includes a polymer containing intermediate water at the time of hydration, and can be suitably used for a medical device, an antithrombotic material, a cell culture substrate, and the like. .

4 is a diagram showing a ¹ H-NMR chart of a polymer synthesized in Synthesis Example 2. FIG. It is the figure which showed the differential scanning calorimetry chart in each water content of the polymer synthesize | combined in the synthesis example 2. FIG. It is the polymer synthesize | combined in the synthesis example 2, and the figure which showed the relationship between the amount of intermediate water of polyvinylpyrrolidone, and the amount of intermediate water / antifreeze water. It is the figure which showed the DSC measurement result of the polymer synthesize | combined in the synthesis example 3. FIG.

The present invention will be described in more detail with reference to the following examples. However, the present invention is not limited to these examples. Unless otherwise specified, “part” means “part by weight” and “%” means “mass%”.

The weight average molecular weight and glass transition temperature of the polymer produced in Synthesis Example 2 were measured using the following apparatus and conditions.
<Weight average molecular weight>
The weight average molecular weight was determined in terms of polyacrylic acid using a gel permeation chromatograph (GPC system, manufactured by Tosoh Corporation).
<Glass transition temperature>
The glass transition temperature (Tg) was determined in accordance with JIS K7121 regulations. Specifically, using a differential scanning calorimeter (Rigaku, Thermo plus EVO DSC-8230), a sample of about 10 mg was heated from room temperature to 200 ° C. (heating rate 20 ° C./min) in a nitrogen gas atmosphere. From the DSC curve obtained in this way, the starting point method was used for evaluation. Α-alumina was used as a reference.

(Synthesis Example 1)
Add 1500 parts by weight of methyl acrylate (containing 300 ppm of methoquinone) and 1480 parts by weight of toluene to a reaction vessel equipped with a thermometer, a dropping device, a condenser, and a stirrer, and heat until the internal temperature reaches 85 ° C. while stirring. . To this was added dropwise 1.5 parts by weight of tris (diethylamino) phosphine dissolved in 20 parts by weight of toluene, and the mixture was reacted for 4 hours with stirring. Subsequently, the obtained reaction liquid was distilled at 200 Torr. First, unreacted methyl acrylate and the solvent toluene were distilled off, and then the pressure was reduced to 15 Torr to obtain dimethyl 2-methyleneglutarate.
Next, 100 parts by weight of the obtained dimethyl 2-methyleneglutarate, 7.7 parts by weight of sulfuric acid, and 100 parts by weight of water were charged into a reaction vessel equipped with a thermometer, a methanol distillation tube, and a stirring device and stirred. The internal temperature of the reaction solution was kept at 110 ° C. and reacted for 6 hours while distilling methanol. After the reaction, the mixture was cooled with stirring to precipitate white crystals, which were filtered and dried to obtain 2-methyleneglutaric acid white crystals.

(Synthesis Example 2)
A reactor equipped with a stirrer, a temperature sensor, a cooling pipe, and a nitrogen introduction pipe was charged with 50 parts by weight of methylene glutaric acid (MGA) obtained in Synthesis Example 1 and 50 parts by weight of ion-exchanged water. Then, the temperature was raised to 80 ° C., and 0.18 part by weight of potassium persulfate was added as a polymerization initiator. Further, 0.18 part by weight of potassium persulfate was added three times every 3 hours, and polymerization was carried out for 12 hours. The obtained polymer solution was reprecipitated and washed with acetone, and dried under reduced pressure to obtain a light yellow solid polymer (p-MGA). FIG. 1 shows a ¹ H-NMR chart (solvent: heavy water) of the obtained polymer. The weight average molecular weight of the obtained polymer was 26,000, and the glass transition temperature was 125 ° C.

(Synthesis Example 3)
A reactor equipped with a stirrer, a temperature sensor, a cooling tube and a nitrogen introduction tube was charged with 50 parts by weight of a commercially available reagent-grade itaconic acid (ItA) and 50 parts by weight of ion-exchanged water. After raising the temperature to 0 ° C., 0.18 parts by weight of potassium persulfate was added as a polymerization initiator. Further, 0.18 part by weight of potassium persulfate was added three times every 3 hours, and polymerization was carried out for 12 hours. The obtained polymer solution was reprecipitated and washed with acetone, and dried under reduced pressure to obtain a light yellow solid polymer (p-ItA). The weight average molecular weight of the obtained polymer was 20,000.

(Example 1 and Comparative Example 1)
The intermediate water content of the polymer synthesized in Synthesis Example 2 was measured by the following method. As Comparative Example 1, the same measurement was performed for polyvinylpyrrolidone (reagent K-30 manufactured by Wako Pure Chemical Industries, Ltd.), which is widely recognized as a polymer excellent in biocompatibility. The results are shown in Table 1.
The differential scanning calorimetry chart at each moisture content of the polymer synthesized in Synthesis Example 2 is shown in FIG. 2, and the intermediate water amount and the intermediate water amount / invalid water amount / absence of the polymer synthesized in Synthesis Example 2 and polyvinylpyrrolidone shown in Table 1 are shown in Table 1. Fig. 3 shows the relationship with the frozen water ratio.
<Measurement of intermediate water volume>
A 0.2 wt% solution in which a sample polymer was dissolved in methanol was cast on a PET disc, and coating was performed twice using a spin coater. An appropriate amount of water was hydrated by a method of providing a saturated water content by exposure to a humid atmosphere. A predetermined amount of each water-containing sample was taken and spread thinly on the bottom of an aluminum oxide pan whose weight was measured in advance. Using a differential scanning calorimeter (DSC-8230, manufactured by Rigaku Corporation), the temperature was cooled from room temperature to −100 ° C. and then held for 10 minutes, and then the rate of temperature increase was 2.5 ° C./min. In the process of heating from −100 ° C. to 50 ° C., the endothermic heat generation amount was measured. It was confirmed that the PET substrate used as the base material for each sample did not produce a significant amount of water.
About each sample, after DSC measurement, the pinhole was made to the aluminum pan, and it vacuum-dried, and calculated | required the weight loss as water content. The water content (WC) was determined by the following formula (I) after excluding the mass of the PET substrate used for the base material.
Water content (WC) = (W1-W0) / W0 (I)
(W0: dry weight of sample (g), W1: wet weight of sample (g))
Next, the maximum amount of antifreeze water and intermediate water is obtained from the relationship between the calorific value associated with cold crystallization at each water content and the endothermic amount near 0 ° C., and divided by W0 to obtain the non-freeze in each sample. The amount of frozen water and the amount of intermediate water were used.

(Example 2)
DSC measurement of p-ItA synthesized in Synthesis Example 3 was performed, and it was confirmed that p-ItA retained intermediate water. FIG. 4 shows the DSC measurement results. There was a melting peak below 0 ° C., and the presence of intermediate water was confirmed.

From the results of Examples 1 and 2, polymethylene glutaric acid (p-MGA) and polyitaconic acid (p-ItA) are polymers having intermediate water when containing water, and can be used as materials for medical devices. It was confirmed. It was also confirmed that polymethylene glutaric acid had a higher ratio of intermediate water to antifreeze water than polyvinylpyrrolidone when compared with the same amount of intermediate water.

Claims (5)

The material used for the part which contacts a biological component or a biological tissue of the medical device used in contact with a biological component or a biological tissue, Comprising: This material is following formula (1);

(Wherein n represents a number from 0 to 2. X and Y each independently represent a hydrogen atom, an alkali metal atom, or an ammonium group). Polymer having (however, having a crosslinked structure and the following general formula
PVG-CONR ₁ R ₂
Wherein, PVG is vinyl (CH = _CR 1 -), Akurirado _{(CH 2 = CR 1 COO-} R 4 -) - is selected from the group consisting of acrylamide _{(CH 2 = CR 1 CONR 5} -R 6) R ₁ is selected from the group of H, —CH ₂ COOR ₇ and C ₁ -C ₅ alkyl; R ₂ , R ₃ , R ₄ , R ₅ , R ₆ and R ₇ are copolymerizable vinyl groups; Having a repeating unit derived from an amide acrylic represented by the following formula: selected from the group consisting of H, C ₁ -C ₆ alkyl, phenyl and cyclohexyl, which may be the same or different and may be unsubstituted characterized in that it comprises a excluding) medical device materials (excluding sealants of dental restorative materials). The said polymer has 10-100 mass% of structural units derived from the monomer represented by the said Formula (1) with respect to 100 mass% of all the monomer units. Medical device materials. A medical device using the medical device material according to claim 1 or 2,
The medical device is characterized in that a portion in contact with a biological component or a biological tissue is configured using the medical device material. An antithrombotic material comprising the medical device material according to claim 1 or 2. A cell culture substrate comprising the medical device material according to claim 1 or 2.

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