Coating systems containing hydrophilic polymers and bilayer coating systems, hydrophilic coatings and applications

Abstract

The present application relates to a kind of coating system and double-layer coating system containing hydrophilic polymer, hydrophilic coating and application.The coating system containing hydrophilic polymer includes reactive hydrophilic polymer Poly1 and reactive monomer Rm1, can be used as the top coating system of double-layer coating system or alone, Poly1 in which has a large number of carbon-carbon double bond, can form dense crosslinking network, Rm1 can further provide physical interpenetration or more dense crosslinking network of chemical secondary crosslinking, so that the formed coating can form a large number of chemical bond connection between bottom coating or substrate layer;The double-layer coating containing hydrophilic polymer further includes bottom coating system, the bottom coating system includes reactive hydrophilic polymer Poly2 and reactive monomer Rm2, can further strengthen the adhesion of hydrophilic coating firmness.The coating system and double-layer coating system made of hydrophilic coating can be used as the hydrophilic lubricating layer of medical device, lubricity is good, friction is low, firmness is high.

Description

[0001] Related applications

[0002] This application is a divisional application of Chinese patent application filed on December 26, 2022, with application number CN202211676225X, entitled "Coating systems containing hydrophilic polymers and bilayer coating systems, hydrophilic coatings and applications", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to the field of medical hydrophilic coating technology, and particularly to a coating system containing a hydrophilic polymer, a bilayer coating system containing a hydrophilic polymer, a hydrophilic coating, and its application. Background Technology

[0004] In the field of medical devices, interventional treatments are gaining increasing acceptance. Many interventional medical devices, such as urinary catheters, balloon dilation catheters, central venous catheters, and endovascular angiography guidewires, experience significant resistance during insertion or removal due to insufficient surface smoothness, leading to pain and tissue damage. Medical catheters (or guidewires) are primarily inserted into the body through natural orifices or tiny puncture wounds, requiring short-term or long-term contact with human tissue. Friction occurs between the catheter (or guidewire) and the directly contacting tissue during insertion or removal, frequently causing burning and pain sensations in patients, and easily leading to tissue damage and adhesions, resulting in a higher risk of complications.

[0005] In clinical practice, lubricants (such as paraffin oil, silicone oil, and petroleum jelly) are often applied to the surface of catheters or guidewires to reduce the above problems; however, in clinical use, silicone oil cannot adhere stably to the surface of catheters or guidewires, has poor lubrication effect, is difficult to maintain, and still causes damage to tissues when inserted or removed from the body. Therefore, researchers are dedicated to developing methods to form a stable hydrophilic lubricating layer on the surface of medical catheters and guidewires, hoping to achieve the following multiple effects: 1. Reduce patient discomfort and avoid damage to mucosa and tissue cells during insertion; 2. Reduce biocontamination, such as reducing the adsorption and accumulation of proteins, cells, bacteria, and microorganisms on the substrate surface; 3. Anticoagulate and reduce the impact on the blood flow environment; 4. Improve device biocompatibility, such as improving blood compatibility; 5. Give medical devices good permeability and improve surgical safety; 6. Expand applicability to a variety of different substrates, such as making the hydrophilic coating applicable to nylon, PEBAX (block polyether amide resin products), PU (polyurethane), PET (polyethylene terephthalate), PVC (polyvinyl chloride), PMMA (polymethyl methacrylate), PEEK (polyether ether ketone), PDMS (polydimethylsiloxane), PE (polyethylene), PP (polypropylene), PTFE (polytetrafluoroethylene), and other substrates. In summary, hydrophilic coatings need to possess properties such as lubricity, resistance to biofouling, good adhesion, biocompatibility, and reliability.

[0006] Currently, there are relatively few products on the market that can meet the comprehensive performance requirements of hydrophilic lubricating layers, and their formulations are quite complex. Therefore, it is still necessary to further develop hydrophilic lubricating layers with clinical application value. Summary of the Invention

[0007] Based on this, the present invention aims to provide a coating system containing a hydrophilic polymer and a two-layer coating system thereof. Both systems can be applied to the surface of plastic substrates for medical devices. The formed hydrophilic coating can serve as a hydrophilic lubricating layer to provide medical devices with lower friction, better lubrication and higher adhesion, which can provide important technical support for the development of implantable medical device products.

[0008] The above-mentioned objectives of the present invention can be achieved through the following technical solutions.

[0009] In a first aspect of the present invention, a coating system containing a hydrophilic polymer is provided, comprising, on a dry weight basis of 100 parts by weight, the following components: 45 to 90 parts by weight of a reactive hydrophilic polymer Poly1, 9.9 to 50 parts by weight of a reactive monomer Rm1, 0.1 to 5 parts by weight of an initiator In1 and a solvent So1;

[0010] The reactive hydrophilic polymer Poly1 has the general structure shown in formula (1);

[0011]

[0012] The reactive monomer Rm1 is capable of undergoing intermolecular crosslinking;

[0013] The initiator In1 is a Norrish type I initiator or a free radical photoinitiator;

[0014] The solvent So1 has a mass percentage content of ≥50% in the coating system;

[0015] In equation (1),

[0016] m is an integer selected from 9 to 100;

[0017] n is an integer selected from 1 to 40;

[0018] Each R1 is an independent hydrophilic group;

[0019] Each A1 is independently H or C. 1-19 alkyl;

[0020] Each A2 is independently C 1-18 Alkylene;

[0021] Each L 11 Independently -O- or -NH-;

[0022] L is a divalent linker, and each L is an independent linker containing a heteroatom selected from one or more of O, S, N and P;

[0023] Each B2 is independently C 1-18 Alkylene;

[0024] Each L 13 Independently -O- or NH;

[0025] Each B1 is independently H or C. 1-19 alkyl;

[0026] "*" indicates the site where the terminal base is connected.

[0027] In a second aspect of the invention, a two-layer coating system containing a hydrophilic polymer is provided, comprising a topcoat system and a primer system; the topcoat system may be selected from the coating system containing a hydrophilic polymer described in the first aspect of the invention.

[0028] In some embodiments, the primer system comprises, on a dry weight basis of 100 parts by weight, the following components: 45 to 90 parts by weight of the reactive hydrophilic polymer Poly2, 9.9 to 50 parts by weight of the reactive monomer Rm2, 0.1 to 5 parts by weight of the initiator In2 and the solvent So2;

[0029] The reactive hydrophilic polymer Poly2 has the general structure shown in formula (4).

[0030]

[0031] The reactive monomer Rm2 is capable of intermolecular crosslinking, and the reactive monomer Rm2 has a polymer chain and a plurality of reactive groups F2 covalently connected to the polymer chain;

[0032] The initiator In2 is a Norrish type I initiator or a free radical photoinitiator;

[0033] The solvent So2 has a mass percentage content of ≥50% in the primer system;

[0034] In equation (4),

[0035] Each X is independently -O-, -NH-, or -N(CH3)-;

[0036] Each Z is independently C 1-18 Alkylene;

[0037] L 21 and L 22 Each is independently selected from: non-existent, -C(=O)-, and *-C(=O)NH-; where * points to X;

[0038] B 21 and B 22 Each independently is C 1-18 Alkylene;

[0039] L 31 and L 32 Each can be independently -O- or -NH-;

[0040] B 11 and B 12 Each can be independently H, methyl, ethyl or C 3-6 alkyl;

[0041] k is an integer selected from 1 to 220.

[0042] In a third aspect of the invention, a hydrophilic coating is provided, which can be prepared from a coating system containing a hydrophilic polymer as described in the first aspect of the invention, or from a bilayer coating system containing a hydrophilic polymer as described in the second aspect of the invention. This hydrophilic coating can serve as a hydrophilic lubricating layer.

[0043] In a fourth aspect of the invention, the application of the coating system containing hydrophilic polymers described in the first aspect of the invention, or the bilayer coating system containing hydrophilic polymers described in the second aspect of the invention, in the preparation of a hydrophilic lubricating layer for a medical device is provided; or the application of the hydrophilic coating described in the third aspect of the invention as a hydrophilic lubricating layer for a medical device is provided.

[0044] In some embodiments, the hydrophilic coating is laminated onto the surface of a plastic substrate that can be implanted in a medical device.

[0045] The first aspect of this invention provides a coating system containing a hydrophilic polymer, which is a simple formulation capable of preparing hydrophilic coatings. It can be used as a topcoat in a two-layer coating system or alone to prepare hydrophilic coatings. The reactive hydrophilic polymer Poly1 contains numerous carbon-carbon double bonds, forming a dense cross-linked network. The reactive monomer Rm1 has polymerization and cross-linking capabilities, further providing a denser cross-linked network of physical interpenetration or chemical secondary cross-linking. This allows the formed coating to form numerous chemical bonds with the undercoat or substrate, providing high lubricity, low friction, and high adhesion. When preparing a two-layer hydrophilic coating, the reactive components in this coating system (including but not limited to Poly1) can also undergo chemical coupling or even cross-linking with reactive groups (including but not limited to carbon-carbon double bonds) in the undercoat, thereby endowing the two-layer hydrophilic coating with excellent adhesion.

[0046] The bilayer coating system provided by the second aspect of the present invention can include the coating system containing hydrophilic polymers as described in the first aspect of the present invention, as well as any suitable primer system, to prepare a bilayer hydrophilic coating with a bilayer structure, which can then be used as a bilayer hydrophilic lubricating layer. The coating system of the first aspect can form the top coating of the hydrophilic lubricating layer, and the primer system can form the bottom coating of the hydrophilic lubricating layer. This bilayer hydrophilic coating can simultaneously achieve high lubricity, low friction, and high adhesion. Further, the primer system used can include a reactive hydrophilic polymer Poly2 and a reactive monomer Rm2. Both components have polymerization and crosslinking capabilities, which can further improve the lubricity of the hydrophilic lubricating layer, reduce friction, and enhance the adhesion of the hydrophilic lubricating layer. The primer system containing the reactive hydrophilic polymer Poly2 can form a primer layer with a crosslinked network. After further coating with a primer containing the reactive hydrophilic polymer Poly1, Poly1 can form a polymer network and also form chemical bonds with the primer layer formed by the primer system, thereby further improving the adjustability and controllability of the adhesion of the hydrophilic coating.

[0047] The hydrophilic coatings made from the aforementioned hydrophilic polymer-containing coating systems and the aforementioned hydrophilic polymer-containing bilayer coating systems can both be used as hydrophilic lubricating layers for medical devices, including but not limited to hydrophilic lubricating layers on the surface of implantable medical devices. They exhibit good lubrication, low friction, and high adhesion. When used as hydrophilic lubricating layers on the surface of implantable medical devices, they can solve or significantly alleviate the problem that existing implantable medical devices easily rub against body tissues during removal, causing patients to experience burning and pain, and easily leading to tissue damage and adhesion, resulting in complications.

[0048] The coating system and double-layer coating system of the present invention containing hydrophilic polymers are applicable to different substrates, and furthermore, they can provide better adhesion to plastic substrates. Attached Figure Description

[0049] To more clearly illustrate the technical solutions in the embodiments of this application and to more completely understand this application and its beneficial effects, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0050] Figure 1 The hydrophilic polymer P(VP-HEMA) in one embodiment of the present invention 1 H NMR spectrum, with the horizontal axis representing the chemical shift δ (denoted as f1), in ppm;

[0051] Figure 2 In one embodiment of the present invention, the reactive hydrophilic polymer P(VP-(HEMA-g-IEM)) 1 H NMR spectrum, with the horizontal axis representing the chemical shift δ (denoted as f1), in ppm;

[0052] Figure 3 The hydrophilic polymer P(VP-HEMA) in one embodiment of the present invention 1 H NMR spectrum, with the horizontal axis representing the chemical shift δ (denoted as f1), in ppm;

[0053] Figure 4 In one embodiment of the present invention, the reactive hydrophilic polymer P(VP-(HEMA-g-IEM)) 1 H NMR spectrum, with the horizontal axis representing the chemical shift δ (denoted as f1), in ppm;

[0054] Figure 5 The hydrophilic polymer P(VP-HEMA) in one embodiment of the present invention 1H NMR spectrum, with the horizontal axis representing the chemical shift δ (denoted as f1), in ppm;

[0055] Figure 6 In one embodiment of the present invention, the reactive hydrophilic polymer P(VP-(HEMA-g-IEM)) 1 H NMR spectrum, with the horizontal axis representing the chemical shift δ (denoted as f1), in ppm;

[0056] Figure 7 In one embodiment of the present invention, the reactive hydrophilic polymer IEM-PTMG-IEM 1 H NMR spectrum, with the horizontal axis representing the chemical shift δ (denoted as f1), in ppm. Detailed Implementation

[0057] The present invention will now be described in further detail with reference to the accompanying drawings, embodiments, and examples. It should be understood that these embodiments and examples are for illustrative purposes only and are not intended to limit the scope of the invention. The purpose of providing these embodiments and examples is to enable a more thorough and complete understanding of the disclosure of the present invention. It should also be understood that the present invention can be implemented in many different forms and is not limited to the embodiments and examples described herein. Those skilled in the art can make various modifications or alterations without departing from the spirit of the present invention, and the equivalent forms obtained also fall within the protection scope of the present invention. For example, features described or illustrated as part of one embodiment can be combined in a suitable manner in another embodiment to produce new embodiments. Furthermore, numerous specific details are set forth in the following description to provide a fuller understanding of the invention. It should be understood that the present invention can be implemented without one or more of these details.

[0058] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for descriptive purposes only and is not intended to be limiting of the invention.

[0059] the term

[0060] Unless otherwise stated or in case of contradiction, the terms or phrases used herein shall have the following meanings:

[0061] The terms "and / or," "or / and," and "and / or" as used herein include any one of two or more of the related listed items, as well as any and all combinations of the related listed items. These arbitrary and all combinations include any two related listed items, any more related listed items, or a combination of all related listed items. It should be noted that when at least three items are connected by at least two conjunctions selected from "and / or," "or / and," and "and / or," it should be understood that in this application, the technical solution undoubtedly includes technical solutions connected by "logical AND," and also undoubtedly includes technical solutions connected by "logical OR." For example, "A and / or B" includes three parallel solutions: A, B, and "a combination of A and B." For example, the technical solution of "A, and / or, B, and / or, C, and / or, D" includes any one of A, B, C, and D (that is, a technical solution that is connected by "logical OR"), as well as any and all combinations of A, B, C, and D, that is, combinations of any two or three of A, B, C, and D, and also combinations of all four of A, B, C, and D (that is, a technical solution that is connected by "logical AND").

[0062] In this invention, terms such as "multiple," "various," and "multiple times" are used, and unless otherwise specified, they refer to a quantity greater than or equal to 2. For example, "one or more" means one or more types.

[0063] The terms “combinations of,” “any combination of,” and “any combination of” used in this article include all suitable combinations of any two or more of the listed items.

[0064] In this document, the term "suitable" as used in "suitable combination", "suitable method", "any suitable method", etc., refers to the ability to implement the technical solution of this invention, solve the technical problem of this invention, and achieve the expected technical effect of this invention.

[0065] In this document, terms such as "preferred," "better," "more suitable," and "ideal" are merely descriptions of more effective implementation methods or embodiments and should be understood not to limit the scope of protection of this invention. If multiple "preferred" terms appear in a technical solution, unless otherwise specified and there are no contradictions or mutual constraints, each "preferred" term shall be independent.

[0066] In this invention, terms such as "further," "even further," and "particularly" are used for descriptive purposes to indicate differences in content between different technical solutions, but should not be construed as limiting the scope of protection of this invention.

[0067] In this invention, "optionally," "optionally," and "optional" mean that something is optional, that is, it refers to either "present" or "absent" as parallel solutions. If multiple "options" appear in a technical solution, unless otherwise specified and there are no contradictions or mutual constraints, each "option" is independent. In this application, descriptions such as "optionally contains" and "optionally includes" indicate "contains or does not contain." "Optional component X" indicates whether component X is present or not.

[0068] In this invention, the terms "first aspect," "second aspect," "third aspect," "fourth aspect," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or quantity, nor should they be construed as implicitly indicating the importance or quantity of the indicated technical features. Moreover, "first," "second," "third," "fourth," etc., serve only as a non-exhaustive enumeration and should be understood not to constitute a closed limitation on the quantity.

[0069] In this invention, the technical features described in an open-ended manner include both closed-ended technical solutions composed of the listed features and open-ended technical solutions that include the listed features.

[0070] In this invention, numerical intervals (i.e., numerical ranges) are involved. Unless otherwise specified, the distribution of selectable values ​​within a numerical interval is considered continuous, and includes the two endpoints (i.e., the minimum and maximum values) of the numerical interval, as well as every value between these two endpoints. Unless otherwise specified, when a numerical interval refers only to integers within that interval, it includes the two endpoint integers of the numerical range, as well as every integer between the two endpoints, which is equivalent to directly listing every integer. For example, if t is an integer selected from 1 to 10, it means that t is any integer selected from the group of integers consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10. When multiple numerical ranges are provided to describe features or characteristics, these numerical ranges can be combined. In other words, unless otherwise specified, the numerical ranges disclosed herein should be understood to include any and all subranges included therein. The "numerical value" in the numerical interval can be any quantitative value, such as a number, percentage, ratio, etc. The "numerical interval" can be broadly included to include numerical interval types such as percentage intervals, ratio intervals, and proportion intervals.

[0071] Unless otherwise specified, the temperature parameters in this invention can be either constant temperature treatment or variations within a certain temperature range. It should be understood that the constant temperature treatment allows temperature fluctuations within the precision range controlled by the instrument. Fluctuations are permitted within ranges such as ±5℃, ±4℃, ±3℃, ±2℃, and ±1℃.

[0072] In this invention, the term "room temperature" or "normal temperature" generally refers to 4℃ to 35℃, for example, 20℃ ± 5℃. In some embodiments of this invention, "room temperature" or "normal temperature" refers to 10℃ to 30℃. In some embodiments of this invention, "room temperature" or "normal temperature" refers to 20℃ to 30℃.

[0073] In this invention, if the unit of a data range is only followed by the right endpoint, it indicates that the units of the left and right endpoints are the same. For example, 3-5h means that the units of the left endpoint "3" and the right endpoint "5" are both h (hours).

[0074] The mass or weight of the relevant components mentioned in the embodiments of this invention can refer not only to the specific content of each component, but also to the proportional relationship of mass or weight between the components. Therefore, any scaling up or down of the content of the relevant components according to the embodiments of this invention is within the scope disclosed in the embodiments of this invention. Specifically, the mass or weight mentioned in the embodiments of this invention can be units known in the chemical industry, such as μg, mg, g, and kg.

[0075] In this invention, where the method involves multiple steps, unless otherwise explicitly stated herein, the execution of these steps is not strictly limited in order and can be performed in any order other than that described. Moreover, any step may include multiple sub-steps or multiple stages, which are not necessarily completed at the same time, but can be executed at different times, and their execution order is not necessarily sequential, but can be performed alternately or simultaneously with other steps or parts of the sub-steps or stages of other steps.

[0076] In this document, the term "alkyl" refers to a monovalent residue formed by the loss of a hydrogen atom from a saturated hydrocarbon containing a primary (normal) carbon atom, or a secondary carbon atom, or a tertiary carbon atom, or a quaternary carbon atom, or a combination thereof. Phrases containing this term, such as "C1-9 alkyl," refer to alkyl groups containing 1 to 9 carbon atoms, and each occurrence can be independently C1 alkyl, C2 alkyl, C3 alkyl, C4 alkyl, C5 alkyl, C6 alkyl, C7 alkyl, C8 alkyl, or C9 alkyl. Suitable examples include, but are not limited to: methyl (Me, -CH3), ethyl (Et, -CH2CH3), 1-propyl (n-Pr, n-propyl, -CH2CH2CH3), 2-propyl (i-Pr, i-propyl, -CH(CH3)2), 1-butyl (n-Bu, n-butyl, -CH2CH2CH2CH3), 2-methyl-1-propyl (i-Bu, i-butyl, -CH2CH(CH3)2), 2-butyl (s-Bu, s-butyl, -CH(C H3)CH2CH3), 2-methyl-2-propyl (t-Bu, t-butyl, -C(CH3)3), 1-pentyl (n-pentyl, -CH2CH2CH2CH2CH3), 2-pentyl (-CH(CH3)CH2CH2CH3), 3-pentyl (-CH(CH2CH3)2), 2-methyl-2-butyl (-C(CH3)2CH2CH3), 3-methyl-2-butyl (-CH(CH3)CH(CH3)2), 3-methyl-1-butyl (- CH2CH2CH(CH3)2), 2-methyl-1-butyl(-CH2CH(CH3)CH2CH3), 1-hexyl(-CH2CH2CH2CH2CH2CH3), 2-hexyl(-CH(CH3)CH2CH2CH2CH3), 3-hexyl(-CH(CH2CH3)(CH2CH2CH3)), 2-methyl-2-pentyl(-C(CH3)2CH2CH2CH3), 3-methyl-2-pentyl(-CH(CH3)CH( CH3)CH2CH3), 4-methyl-2-pentyl (-CH(CH3)CH2CH(CH3)2), 3-methyl-3-pentyl (-C(CH3)(CH2CH3)2), 2-methyl-3-pentyl (-CH(CH2CH3)CH(CH3)2), 2,3-dimethyl-2-butyl (-C(CH3)2CH(CH3)2), 3,3-dimethyl-2-butyl (-CH(CH3)C(CH3)3 and octyl (-(CH2)7CH3).

[0077] In this document, the term "alkylene" refers to a hydrocarbon group with two monovalent groups derived from an alkyl group by removing one hydrogen atom. It can be a saturated branched alkyl group or a saturated straight-chain alkyl group. For example, "C1-C9 alkylene" refers to an alkyl moiety containing 1 to 9 carbon atoms, and each occurrence can be independently C1, C2, C3, C4, C5, C6, C7, C8, or C9 alkylene. Suitable examples include, but are not limited to: methylene (-CH2-), 1,1-ethyl (-CH(CH3)-), 1,2-ethyl (-CH2CH2-), 1,1-propyl (-CH(CH2CH3)-), 1,2-propyl (-CH2CH(CH3)-), 1,3-propyl (-CH2CH2CH2-), and 1,4-butyl (-CH2CH2CH2CH2-).

[0078] As used herein, "polymer" refers to a polymer having multiple (≥2) repeating units. Unless otherwise specified, the molecular weight of a polymer in this document refers to its average molecular weight.

[0079] As used in this article, "small molecules" refers to molecules with a molecular weight of less than 1000 Da.

[0080] As used in this article, "hydrophilic group" refers to an atomic group that is soluble in water or readily affinity for water. Hydrophilic groups may attract water molecules or dissolve in water, and solid surfaces with such functional groups are easily wetted by water.

[0081] As used in this article, "reactive group" and "functional group" both refer to groups that can undergo coupling reactions to form covalent bonds.

[0082] As used in this article, a “functional group pair” is a pair of functional groups consisting of two identical or different functional groups. The two functional groups that make up a “functional group pair” can undergo a coupling reaction to form a covalent bond.

[0083] In this article, unless otherwise specified, "approximately" means within a certain range above and below the given number. The range of fluctuation may vary depending on the type and value of the given number. For example, a range of ±10%, ±5%, ±2%, ±1% is allowed. For example, approximately 600 Da can be expressed as 600 ± 60 Da.

[0084] In a first aspect of the invention, a coating system containing a hydrophilic polymer is provided, comprising a reactive hydrophilic polymer Poly1 and a reactive monomer Rm1, which can be used to form a hydrophilic coating, providing lower friction, better hydrophilic lubricity, and higher coating adhesion. This coating system containing the hydrophilic polymer can be used as a top coat in a two-layer coating system, or it can be used alone to provide a single-layer hydrophilic coating. Accordingly, the formed hydrophilic coating can serve as a top coat in a two-layer hydrophilic lubrication layer, or it can serve as a single-layer hydrophilic lubrication layer.

[0085] In this invention, a "coating system" refers to a combined system composed of related components, which can be packaged as a single unit or packaged separately in multiple containers. The components in the "coating system" can be mixed in a suitable manner to form a coating composition, which is then applied to obtain the corresponding coating structure.

[0086] In this invention, "coating" refers to a structural layer made by coating relevant components. After coating, it can be dried, and can be in an undried or partially dried state, or it can be a structural layer in the final product.

[0087] In this invention, "coating layer" refers to a liquid layer of a coating composition applied to a structural surface.

[0088] In some embodiments, a coating system containing a hydrophilic polymer is provided, comprising a reactive hydrophilic polymer Poly1 and a reactive monomer Rm1, further comprising an initiator In1 and a solvent (denoted as solvent So1). This coating system can be used alone to form a monolayer hydrophilic coating, or it can be used as a topcoat system for a bilayer hydrophilic coating to form a bilayer hydrophilic coating. In this coating system, Poly1 has a large number of carbon-carbon double bonds, which can form a dense cross-linked network. Rm1 can further provide a denser cross-linked network of physically interpenetrating or chemically secondary cross-linked bonds, enabling the formed coating to form a large number of chemical bonds with the undercoat or substrate, providing high lubricity and low friction while also providing high adhesion. When preparing a bilayer hydrophilic coating, it can be used in conjunction with a primer system to prepare a bilayer hydrophilic lubricating layer. In this case, the reactive components in the coating system (including but not limited to Poly1) can chemically couple or even crosslink with the reactive groups (including but not limited to carbon-carbon double bonds) in the primer, forming numerous chemical bonds between the top and bottom coatings. This imparts excellent adhesion to the bilayer hydrophilic coating, resulting in a bilayer hydrophilic lubricating layer with good lubricity, low friction, and high adhesion. Based on this, it can be applied to the modification of surface hydrophilic coatings, including but not limited to hydrophilic lubricating layers implantable on the surface of medical devices. Furthermore, this coating system containing hydrophilic polymers can achieve excellent comprehensive performance of high lubricity, low friction, and high adhesion without the addition of benzophenone initiators and adhesion promoters (such as PAcA, Poly(acrylamide-co-acrylic acid), acrylamide-co-acrylic acid copolymer).

[0089] In some embodiments, the coating system containing a hydrophilic polymer provided in the first aspect of the present invention comprises the following components: 45 to 90 parts by weight of a reactive hydrophilic polymer Poly1, 9.9 to 50 parts by weight of a reactive monomer Rm1, 0.1 to 5 parts by weight of an initiator In1, and a solvent So1; further, based on 100 parts by weight on a dry weight basis; and even further, the solvent So1 has a mass percentage content of ≥50% in the coating system.

[0090] In this application, "dry weight of the coating system" refers to the sum of the weights of all components other than the solvent, unless otherwise specified. The dry weight components of the coating system described in the first aspect may include the reactive hydrophilic polymer Poly1, the reactive monomer Rm1, and the initiator In1. The dry weight components of the coating system can be mixed using a solvent at the concentration stated during coating, or a smaller amount of solvent can be used to prepare a concentrated solution for easy storage and transportation, which can then be diluted to the required concentration with additional solvent before use.

[0091] In some embodiments, the present invention provides a reactive hydrophilic polymer Poly1 with high crosslinking ability, the hydrophilicity, polarity and reactivity of the reactive hydrophilic polymer can be adjusted and controlled by adjusting the monomer equivalent ratio.

[0092] In some embodiments, the reactive hydrophilic polymer Poly1 has m repeating units U1 and n repeating units U2; wherein m can be an integer selected from 9 to 100; n can be an integer selected from 2 to 40; R1 is a hydrophilic group; A1 can be H or alkyl; L 11 It can be -O- or -NH-; A2 can be an alkylene group; L can be a divalent linker; B2 can be an alkylene group; L 13 B1 can be -O- or -NH-; B1 can be H or alkyl; "[]" brackets indicate the smallest unit structure of the repeating unit. In this case, the reactive hydrophilic polymer Poly1 can be represented by the structure shown in formula (1). It can be understood that the representation shown in formula (1) is only to clearly show the repeating units of the copolymer and does not restrict the arrangement of the repeating units. For example, the copolymer shown in formula (1) can be a random copolymer, that is, the repeating units U1 and U2 can be randomly distributed in formula (1).

[0093] When L 11 and L 13 When all are 0, the repeating unit U2 can be represented as shown in the structure U2a.

[0094]

[0095] The following groups in formula (1) have a quantity greater than 1: R1, A1, L 11 A2, L, B2, L 13 In the same molecule, groups with the same symbol can be identical or different from each other. When the number of any one type of group is greater than one, multiple groups can be identical or different. In some preferred embodiments, for R1, A1, L... 11 A2, L, B2, L 13 Each of the groups in B1 and A1 can independently have the same structure, and groups with the same symbol can have the same structure. In the same molecule, R1 can be independently identical; A1 can be independently identical; L... 11 A2 can be independently identical; L can be independently identical; B2 can be independently identical; L 13 They can be independently identical; B1 can be independently identical.

[0096] In some preferred embodiments, R1, A2, B2, and B1 are all the same in the same molecule.

[0097] In some preferred embodiments, L is the same in the same molecule.

[0098] In some preferred embodiments, L in the same molecule 11 They are all the same.

[0099] In some preferred embodiments, L in the same molecule 13 They are all the same.

[0100] In some embodiments, the reactive hydrophilic polymer Poly1 has the general formula structure shown in formula (1); in formula (1),

[0101] m is an integer selected from 9 to 100;

[0102] n is an integer selected from 1 to 40;

[0103] Each R1 is an independent hydrophilic group;

[0104] Each A1 is independently H or C. 1-19 alkyl;

[0105] Each A2 is independently C 1-18 Alkylene;

[0106] Each L 11 Independently -O- or -NH-;

[0107] L is a divalent linker, and each L is an independent linker containing a heteroatom selected from one or more of O, S, N and P;

[0108] Each B2 is independently C 1-18 Alkylene;

[0109] Each L 13 Independently -O- or NH;

[0110] Each B1 is independently H or C. 1-19 alkyl;

[0111] "*" indicates the site where the terminal base is connected.

[0112] In this invention, polymer end groups connected by "*" refer to end groups formed in a carbon-carbon double bond free radical polymerization system, unless otherwise specified, and can be formed in the initiation or termination stage. Those skilled in the art will know the structure of the corresponding end groups. In this invention, the structural formulas such as formula (1) formed by the polymerization of monomers containing carbon-carbon double bonds and their end groups are clear to those skilled in the art.

[0113] When L in equation (1) 11 and L 13When all are 0, the structure shown in equation (1) can be expressed as equation (1a).

[0114] When R1 in formula (1) is an N-pyrrolidone group Then, the structure shown in equation (1) can be expressed as equation (1b). Further, L 11 and L 13 When both are 0, the structures shown in equations (1) and (1b) can be represented as equation (1c).

[0115] In some embodiments, L is -O-, -OC(=O)-, or -OC(=O)-NH-, and L is preferably -OC(=O)-NH-, and the -O- end is connected to A2.

[0116]

[0117] When L in formula (1) is -R3-C(O)-NH and R3 is connected to A2, the structure shown in formula (1) can be represented as formula (2). The reactive hydrophilic polymer Poly1 has the general structure shown in formula (2), further wherein each R3 is independently -O- or -NH-. In some embodiments, R3 can be either -O- or -NH-. In some embodiments, R3 is -O-. In some embodiments, R3 is -NH-.

[0118]

[0119] When R1 in equation (2) is an N-pyrrolidone group When, the structure shown in equation (2) can be expressed as equation (2a). Further, when L in equation (2a) 11 and L 13 When both are O, the structures shown in formulas (2) and (2a) can be represented as formula (2b). In some embodiments, the reactive hydrophilic polymer Poly1 has the general formula structure shown in formula (2b), further wherein A1 can be methyl, A2 can be 1,2-ethylene, R3 can be -O-, B2 can be 1,2-ethylene, and B1 can be methyl. In some embodiments, in formula (2b), A1 is methyl, A2 is 1,2-ethylene, R3 is -O-, B2 is 1,2-ethylene, and B1 is methyl.

[0120] In some embodiments, the initiator In1 is a Norrish type I initiator or a free radical photoinitiator.

[0121] In some embodiments, the reactive monomer Rm1 is capable of intermolecular crosslinking. In some preferred embodiments, the reactive monomer Rm1 has a polymer chain and a plurality of reactive groups F1 covalently linked to the polymer chain.

[0122] In some embodiments, the reactive hydrophilic polymer Poly1 has the general structure shown in formula (1), and the repeating units U1 and U2 are randomly distributed in formula (1).

[0123] In some embodiments, the number-average molecular weight of the reactive hydrophilic polymer Poly1 is selected from 1.5 kDa to 22 kDa, further selected from 2 kDa to 20 kDa, and even further selected from 3 kDa to 6 kDa. Non-limiting examples of the number-average molecular weight of the reactive hydrophilic polymer Poly1 include 2 kDa, 3 kDa, 4 kDa, 5 kDa, 6 kDa, 7 kDa, 8 kDa, 9 kDa, 10 kDa, 11 kDa, 12 kDa, 13 kDa, 14 kDa, 15 kDa, 16 kDa, 17 kDa, 18 kDa, 19 kDa, and 20 kDa, and it can also be selected from any of the aforementioned molecular weight ranges.

[0124] In some embodiments, the weight-average molecular weight of the reactive hydrophilic polymer Poly1 is selected from 1.5 kDa to 25 kDa, further selected from 2 kDa to 20 kDa, and even further selected from 3 kDa to 6 kDa. Non-limiting examples of the weight-average molecular weight of the reactive hydrophilic polymer Poly1 include 2 kDa, 3 kDa, 4 kDa, 5 kDa, 6 kDa, 7 kDa, 8 kDa, 9 kDa, 10 kDa, 11 kDa, 12 kDa, 13 kDa, 14 kDa, 15 kDa, 16 kDa, 17 kDa, 18 kDa, 19 kDa, 20 kDa, 21 kDa, 22 kDa, 23 kDa, 24 kDa, and 25 kDa, and may also be selected from any of the aforementioned molecular weight ranges.

[0125] In some implementations, m is an integer selected from 9 to 100. m can be any of the following integers: 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, etc. It can also be selected from any two suitable integers from the above. Some non-limiting examples are 10 to 50, 15 to 40, etc.

[0126] In some implementations, n is an integer selected from 1 to 40. n can be any of the following integers: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, and 40. It can also be selected from any two suitable integers from the above. Some non-limiting examples include 4 to 30, 4 to 20, etc.

[0127] In this document, m and n can be combined in any suitable manner. In some embodiments, m is an integer selected from 10 to 50; n is an integer selected from 4 to 30. In some embodiments, m is an integer selected from 15 to 40; n is an integer selected from 4 to 20.

[0128] In some implementations, the ratio of m to n is selected from (1 to 99):1 (i.e., 1:1 to 99:1), and can be selected from any of the following ratios: 1:1, 1.5:1, 2:1, 7:3, 2.5:1, 3:1, 3.5:1, 4:1, 5:1, 6:1, 8:1, 10:1, 12:1, 15:1, 16:1, 18:1, 19:1, 20:1, 25:1, 30:1, 40:1, 50:1, etc., or can be selected from any range of two suitable ratios mentioned above. Some non-limiting examples are (1 to 19):1 (i.e., 1:1 to 19:1), (1 to 12):1, (1 to 2):1, (2 to 2.5):1, etc.

[0129] In this document, m, n, and their ratio m:n can be combined in any suitable manner. In some embodiments, m is an integer selected from 10 to 50; n is an integer selected from 4 to 30; and the ratio of m to n is selected from 1:1 to 99:1. In some embodiments, m is an integer selected from 15 to 40; n is an integer selected from 4 to 20; and the ratio of m to n is selected from (1 to 19):1.

[0130] In some embodiments, the number-average molecular weight of the reactive hydrophilic polymer Poly1 and the m:n ratio can be combined in any suitable manner. In some embodiments, the number-average molecular weight of the reactive hydrophilic polymer Poly1 is selected from 1.5 kDa to 25 kDa (further, any suitable range herein, such as 3 kDa to 6 kDa), and the m:n ratio is from 1:1 to 99:1 (further, any suitable ratio herein, such as 19:1).

[0131] In some embodiments, R1 in the same molecule is independently -CHO, -COOH, -OH, -NH2, Hydrophilic groups. In some embodiments, R1 is the same in all molecules. In some embodiments, R1 is -CHO, -COOHH, -OH, -NH2, etc. Any of the hydrophilic groups. In some preferred embodiments, R1 is...

[0132] In some embodiments, each Al in the same molecule is independently H or an alkyl group, and may further be independently H or C. 1-19 Alkyl; furthermore, it can independently be H, methyl, ethyl, or -(CH2). j1 -CH3, j1 is an integer selected from 2 to 18; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl, decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, hexadecyl, heptyl, octadecyl, or nonadecanyl; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl, or decyl; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, or octyl; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, or hexyl. In some embodiments, each A1 is independently H, methyl, ethyl, or C. 3-6 Alkyl group. In some preferred embodiments, A1 is an alkyl group, and may further be C1. 1-19 Alkyl; further, it can be methyl, ethyl, or -(CH2). j1 -CH3, j1 is an integer selected from 2 to 18. In some preferred examples, A1 is C 1-18 Alkyl group. In some preferred embodiments, A1 is C1. 1-16 Alkyl group. In some preferred embodiments, A1 is C1. 1-12 Alkyl group. In some preferred embodiments, A1 is C1. 1-10 Alkyl group. In some preferred embodiments, A1 is C1. 1-8 Alkyl group. In some preferred embodiments, A1 is C1. 1-6 Alkyl group (selected from methyl, ethyl, propyl, butyl, pentyl, and hexyl). In some preferred embodiments, A1 is C. 1-3 Alkyl (specifically methyl, ethyl, or propyl). In some embodiments, each A1 is independently H or methyl. In some embodiments, A1 is either H or methyl. In some preferred embodiments, A1 is H. In some preferred embodiments, A1 is methyl. In all embodiments herein, A1 in the same molecule may be identical.

[0133] In some embodiments, each A2 in the same molecule is independently an alkylene group, and may further be independently a C2 group. 1-18 Alkylene, and further, can independently be C 1-16Alkylene, and further, can independently be C 1-12 Alkylene, and further, can independently be C 1-10 Alkylene, and further, can independently be C 1-8 Alkylenes (specifically, they can be methylene, ethylene, propylene, butylene, pentylene, hexylene, heptylene, or octylene), and more specifically, they can be independently C10. 1-6 Alkylene (specifically, it can be methylene, ethylene, propylene, butylene, pentylene, or hexylene), and more specifically, it can be independently C10. 1-3 Alkylene (specifically, it can be methylene, ethylene, or propylene). In some embodiments, each A2 is independently C. 2-8 Alkylene. In some preferred embodiments, each A2 may independently be -(CH2). q1 -; where q1 is an integer selected from 2 to 18 (specifically, it can be 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, or 18), further selected from 2 to 16, even further selected from 2 to 12, even further selected from 2 to 10, and even further selected from 2, 3, 4, 5, or 6; in some embodiments, q1 is 4. In some embodiments, each A2 is independently methylene, 1,2-ethylene, 1,3-propylene, 1,4-butylene, 1,5-pentylene, 1,6-hexylene, 1,7-heptylene, or 1,8-octylene. In some preferred embodiments, A2 is -CH2CH2-. In the various embodiments herein, A2 in the same molecule can all be the same.

[0134] In some implementations, each L in the same molecule 11 Independently -O- or -NH-. In some implementations, L 11 It is either -O- or -NH-. In some embodiments, L 11 For -O-. In some implementations, L 11 It is -NH-.

[0135] In this invention, L is a divalent linker. Further, L is preferably a divalent linker generated by a coupling reaction of a reactive group. In some embodiments, each L in the same molecule is independently a linker containing a heteroatom, further, the heteroatom may be selected from one or more of O, S, N, and P. In some embodiments, each L is independently a divalent linker containing a coupling reaction residue of -NH2 or -OH. In some embodiments, each L is independently a coupling reaction residue of NH2 or -OH. For example, -NH2 can react with -COOH, succinimide carbonyl (-CO-NHS, where NHS is... ), succinimide carbonate group (-OC(=O)-NHS, Acyl halides (such as acyl chlorides), -NCO, etc., can undergo coupling reactions to generate divalent linkages such as -NH-C(=O)-, -NH-C(=O)-O, -NH-C(=O)-, -NH-C(=O)-NH-, etc., in which case the coupling residue of -NH2 is -NH-. For example, -OH can undergo coupling reactions with -COOH, succinimidyl carbonate (-CO-NHS), succinimidyl carbonate (-OC(=O)-NHS), acyl halides (such as acyl chlorides), -NCO, etc., to generate divalent linkages such as -OC(=O)-, -OC(=O)-, -OC(=O)-, -OC(=O)-, -OC(=O)-NH-, etc., in which case the coupling residue of -OH is -O-. In some embodiments, each L is independently a divalent linkage containing R0, where R0 is -O- or -NH-, and R0 is connected to A2. In some embodiments, L is a divalent linker containing -O-, and -O- is linked to A2. In some embodiments, L is a divalent linker containing -NH-, and -NH- is linked to A2. In some embodiments, each L can be independently selected from any one of -NH-, *-NH-C(=O)-, *-NH-C(=O)-NH-, -O-, *-OC(=O)-, and *-OC(=O)-NH-, where * indicates a linker site pointing to A2. In some embodiments, each L can be independently -R3-C(=O)-NH, where R3 is linked to A2; further, each R3 can be independently -O- or -NH-. In some embodiments, R3 is -O-, in which case L is -OC(=O)-NH, where the -O- segment is linked to A2. In all embodiments herein, L in the same molecule can be the same. In some implementations, L is selected from any one of *-NH-, *-NH-C(=O)-, *-NH-C(=O)-NH-, -O-, *-OC(=O)-, and *-OC(=O)-NH-, where * indicates a linking site pointing to A2.

[0136] In some embodiments, each B2 in the same molecule is independently an alkylene group, and may further be independently a C group. 1-18 Alkylene, and further, can independently be C 1-16 Alkylene, and further, can independently be C 1-12 Alkylene, and further, can independently be C 1-10 Alkylene, and further, can independently be C 1-8 Alkylenes (specifically, they can be methylene, ethylene, propylene, butylene, pentylene, hexylene, heptylene, or octylene), and more specifically, they can be independently C10. 1-6Alkylene (specifically, it can be methylene, ethylene, propylene, butylene, pentylene, or hexylene), and more specifically, it can be independently C10. 1-3 Alkylene (specifically, methylene, ethylene, or propylene). In some embodiments, each B2 is independently C. 2-8 Alkylene. In some preferred embodiments, each B2 may be independently -(CH2). q2 -; where q2 is an integer selected from 2 to 18 (specifically, it can be 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, or 18), further selected from 2 to 16, even further selected from 2 to 12, even further selected from 2 to 10, and even further selected from 2, 3, 4, 5, or 6; in some embodiments, q2 is 4. In some embodiments, each B2 is independently methylene, 1,2-ethylene, 1,3-propylene, 1,4-butylene, 1,5-pentylene, 1,6-hexylene, 1,7-heptylene, or 1,8-octylene. In some preferred embodiments, B2 is -CH2CH2- (i.e., 1,2-ethylene). In some preferred embodiments, B2 is 1,4-butylene. In the various embodiments herein, B2 in the same molecule can be all the same.

[0137] In some implementations, each L in the same molecule 13 Independently -O- or -NH-. In some implementations, L 13 It is either -O- or -NH-. In some embodiments, L 13 For -O-. In some implementations, L 13 It is -NH-.

[0138] In some embodiments, each B1 in the same molecule is independently H or alkyl, and may further be independently H or C. 1-19 Alkyl; furthermore, it can independently be H, methyl, ethyl, or -(CH2). j2 -CH3, j2 is an integer selected from 2 to 18; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl, decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, hexadecyl, heptyl, octadecyl, or nonadecanyl; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl, or decyl; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, or octyl; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, or hexyl. In some embodiments, each B1 is independently H, methyl, ethyl, or C. 3-6Alkyl group. In some preferred embodiments, each B1 is independently an alkyl group, and may further be independently C1. 1-19 Alkyl; furthermore, it can independently be methyl, ethyl, or -(CH2). j2 -CH3; where j2 is an integer selected from 2 to 18. In some preferred embodiments, B1 is an alkyl group. In some preferred embodiments, B1 is C 1-18 Alkyl group. In some preferred embodiments, B1 is C. 1-16 Alkyl group. In some preferred embodiments, B1 is C. 1-12 Alkyl group. In some preferred embodiments, B1 is C. 1-10 Alkyl group. In some preferred embodiments, B1 is C. 1-8 Alkyl group. In some preferred embodiments, B1 is C. 1-6 Alkyl group (selected from methyl, ethyl, propyl, butyl, pentyl, and hexyl). In some preferred embodiments, B1 is C. 1-3 Alkyl (specifically methyl, ethyl, or propyl). In some embodiments, each B1 is independently H or methyl. In some embodiments, B1 is either H or methyl. In some preferred embodiments, B1 is H. In some preferred embodiments, B1 is methyl. In all embodiments herein, B1 in the same molecule may be identical.

[0139] In this invention, R1, A1, A2, L, L 11 L 13 B1, B2, R3, m, and n can be combined in any suitable way, and further, they can be combined in any suitable way in any structural formula in this paper.

[0140] In some embodiments, A2 is 1,2-ethylene and R3 is -O-.

[0141] In some embodiments, B2 is 1,2-ethylene and B1 is methyl.

[0142] In some embodiments, A1 is methyl and B1 is methyl.

[0143] In some embodiments, A2 is 1,2-ethylidene and B2 is 1,2-ethylidene.

[0144] In some embodiments of the present invention, equation (1) satisfies any one or more of the following features:

[0145] Each R1 is independently -CHO, -COOH, -OH, -NH2, or

[0146] Each A1 is independently H, methyl, ethyl, or C. 3-6 alkyl;

[0147] Each A2 is independently C 2-8 Alkylene;

[0148] L 11 -O-;

[0149] Each L is independently a divalent linker containing R0, where R0 is -O- or -NH-, and R0 is connected to A2;

[0150] Each B2 is independently C 2-8 Alkylene;

[0151] L 13 -O-;

[0152] Each B1 is independently H, methyl, ethyl, or C. 3-6 alkyl.

[0153] In some embodiments of the present invention, equation (1) satisfies any one or more of the following features:

[0154] Each R1 is independently -CHO, -COOH, -OH, -NH2, or

[0155] A1 can be H, methyl, ethyl, or -(CH2). j1 -CH3, j1 is an integer selected from 2 to 18;

[0156] A2 is -(CH2) q1 -, q1 is an integer selected from 2 to 18;

[0157] L is a divalent linker containing R0, where R0 is -O- or -NH-, and R0 is connected to A2;

[0158] B2 is -(CH2) q2 -, q2 is an integer selected from 2 to 18;

[0159] B1 can be H, methyl, ethyl, or -(CH2). j2 -CH3,j2 is an integer selected from 2 to 18.

[0160] In some embodiments of the present invention, A1 is H or methyl; B1 is H or methyl. Further, in some embodiments of the present invention, A1 is methyl; B1 is methyl.

[0161] In some embodiments of the present invention, A2 is methylene, ethylene, propylene, butylene, pentylene, hexylene, heptylene, or octylene; and / or, B2 is methylene, ethylene, propylene, butylene, pentylene, hexylene, heptylene, or octylene.

[0162] In some preferred embodiments of the present invention, L is -R3-C(=O)-NH-, wherein -R3- is connected to A2; in this case, the reactive hydrophilic polymer Poly1 has the general formula structure shown in formula (2):

[0163] Furthermore, in some preferred examples, R3 is -O- or -NH-. The definitions of the remaining parameters can be found above.

[0164] In some preferred embodiments of the present invention, R3 is -O-, and the reactive hydrophilic polymer Poly1 has the general formula structure shown in formula (2d):

[0165] The definitions of each parameter in equation (2d) can be found in the previous text.

[0166] In some preferred embodiments of the present invention, the reactive hydrophilic polymer Poly1 has the general structure shown in formula (3a), where A1 is methyl; further, B1 can also be methyl, as shown in formula (3b). The definitions of each parameter can be found above.

[0167]

[0168] In some embodiments, the reactive hydrophilic polymer Poly1 accounts for 45% to 90% of the dry weight of the coating system containing the hydrophilic polymer in the first aspect of the invention. It can also be selected from any of the following percentages: 45%, 47%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, etc., or from any range of two of the above percentages. Some non-limiting examples include 45% to 85%, 47% to 80%, 70% to 90%, 75% to 85%, 45% to 54%, etc.

[0169] In this application, unless otherwise specified, "percentage by mass in the dry weight of the coating system" refers to the dry weight of the coating system as 100%. "Percentage by mass in the coating system" refers to the total weight of the coating system including the solvent as 100%.

[0170] In some embodiments, the reactive hydrophilic polymer Poly1 in the coating system containing the hydrophilic polymer in the first aspect of the invention comprises 4% to 30% by mass, and may also be selected from any of the following percentages: 4%, 5%, 6%, 7%, 8%, 9%, 10%, 12%, 15%, 16%, 18%, 20%, 22%, 24%, 25%, 26%, 8%, 30%, etc., or may be selected from any range of two of the above percentages. Some non-limiting examples include 5% to 12%, 5% to 8%, 8% to 15%, 6% to 10%, 4% to 6%, etc.

[0171] In this invention, the reactive monomer Rm1 is capable of intermolecular crosslinking. In some embodiments, the reactive monomer Rm1 can also act as a crosslinking agent. In some embodiments, the reactive monomer Rm1 has a polymer chain and a plurality (≥2 or ≥3) reactive groups F1 covalently linked to the polymer chain. In some embodiments, the polymer chain in the reactive monomer Rm1 is selected from one or more structures of the group consisting of: polyether, polyurethane, polyethylene, polypropylene, polyvinyl chloride, polyethylene oxide, polyamide, polyacrylamide, poly(meth)acrylic acid, polyvinyl alcohol, polyethyleneimine, polyester and alkyd copolymers, polypeptides, polysaccharides, etc. In some embodiments, the reactive group F1 is selected from one or more groups of the group consisting of: carbon-carbon unsaturated bonds, -NH2, -CONH2, and -SH, preferably carbon-carbon unsaturated bonds. When the reactive monomer Rm1 includes carbon-carbon unsaturated bonds, the reactive monomer Rm1 may include one or more structures of alkenyl, unsaturated ester, unsaturated ether, unsaturated amide, and dry alkyd resin. In some embodiments of this invention, the carbon-carbon unsaturated bonds in Rm1 are provided by alkenyl groups. In some embodiments of the invention, the carbon-carbon unsaturated bonds are provided by unsaturated structures selected from the group consisting of unsaturated esters, acrylates, methacrylates, unsaturated ethers, unsaturated amides, etc. In some suitable examples, the reactive monomer Rm1 is a polymer having an unsaturated ester, unsaturated amide, unsaturated ether, unsaturated thiol, or unsaturated mercaptan group.

[0172] In some embodiments, the reactive monomer Rm1 is selected from one or more polyethers modified with multiple carbon-carbon unsaturated bonds. In some embodiments, the multiple polyethers modified with multiple carbon-carbon unsaturated bonds include polyethylene glycol modified with multiple carbon-carbon unsaturated bonds and polytetrahydrofuran modified with multiple carbon-carbon unsaturated bonds. In some embodiments, the reactive monomer Rm1 is polyethylene glycol diacrylate or polyethylene glycol dimethacrylate. In some embodiments, the reactive monomer Rm1 is polyethylene glycol diacrylate.

[0173] In some embodiments, the number-average molecular weight of the reactive monomer Rm1 is about 600 Da to about 10,000 Da, further about 600 Da to about 5,000 Da, and even further about 1,000 Da to about 5,000 Da. The number-average molecular weight of the reactive monomer Rm1 can be selected from any of the following molecular weights: 600 Da, 700 Da, 800 Da, 900 Da, 1000 Da, 1100 Da, 1200 Da, 1300 Da, 1400 Da, 1500 Da, 1600 Da, 1800 Da, 2000 Da, 2500 Da, 3000 Da, 3500 Da, 4000 Da, 4500 Da, 5000 Da, 5100 Da, 5200 Da, 5300 Da, 5400 Da, 5500 Da, 5600 Da, 5800 Da, 6000 Da, etc., or can be selected from any two of the aforementioned molecular weight ranges, with some non-limiting examples such as 800 Da to 2000 Da.

[0174] In some embodiments, the reactive monomer Rm1 accounts for 9.9% to 50% of the dry weight of the coating system containing the hydrophilic polymer in the first aspect of the invention, and may also be selected from any of the following percentages: 9.9%, 10%, 14.5%, 15%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 42%, 45%, 48%, 50%, etc., or may be selected from any range of two of the above percentages. Some non-limiting examples include 14.5% to 50%, 19% to 48%, 9.9% to 25%, 14.5% to 20%, 42% to 50%, etc.

[0175] In some embodiments, the reactive monomer Rm1 in the coating system containing the hydrophilic polymer in the first aspect of the invention has a mass percentage content of 1.9% to 19%, and may also be selected from any of the following percentages: 1.9%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 9.9%, 10%, 14.5%, 15%, 18%, 19%, etc., and may also be selected from the range of any two of the above percentages. Some non-limiting examples include 2% to 8%, 2% to 5%, 1.9% to 4.8%, 1% to 4%, 4% to 6%, etc.

[0176] In this invention, the initiator In1 can initiate the polymerization reaction of the reactive hydrophilic polymer Poly1.

[0177] In some embodiments, the initiator In1 is a Norrish type I initiator or a free radical photoinitiator, in which case the reaction rate is faster. In some embodiments, the initiator In1 is selected from one or more of the following: benzoin initiators, 4-benzoyl-1,3-dioxapentane initiators, benzyl ketal, α,α-dialkoxyacetophenone, α-hydroxyalkylphenone, α-aminoalkylphenone, acyl phosphorus oxide, diacyl phosphine oxide, acyl sulfide, and haloacetophenone initiators. Examples of initiators In1 include, but are not limited to, the following products: Irgacure 2959 (2-hydroxy-4'-(2-hydroxyethoxy)-2-methylphenylethyl ketone), Irgacure 651 (benzyl dimethyl ketal or 2,2-dimethoxy-1,2-diphenyl ethyl ketone), Irgacure 184 (1-hydroxy-cyclohexyl-phenyl ketone as the active component), etc. Initiator In1 can be a single initiator or a combination of multiple initiators.

[0178] In some embodiments, the initiator In1 accounts for 0.1% to 5% by dry weight in the dry weight of the coating system containing the hydrophilic polymer in the first aspect of the invention. It may also be selected from any of the following percentages: 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.2%, 1.5%, 1.6%, 1.8%, 1.9%, 2%, 2.2%, 2.4%, 2.5%, 2.6%, 2.8%, 3%, 3.2%, 3.5%, 3.6%, 4%, 4.5%, 4.8%, 5%, etc. It may also be selected from the range of any two of the above percentages. Some non-limiting examples include 0.5% to 5%, 0.9% to 5%, 0.1% to 3%, 0.5% to 2%, 4% to 5%, etc.

[0179] In some embodiments, the initiator In1 comprises 0.05% to 1% by mass in the coating system containing the hydrophilic polymer in the first aspect of the invention, and may also be selected from any of the following percentages: 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.12%, 0.15%, 0.16%, 0.18%, 0.2%, 0.22%, 0.24%, 0.25%, 0.26%, 0.28%, 0.3%, 0.32%, 0.35%. The percentages can be 0.36%, 0.38%, 0.4%, 0.42%, 0.45%, 0.48%, 0.5%, 0.55%, 0.6%, 0.65%, 0.7%, 0.75%, 0.8%, 0.85%, 0.9%, 0.95%, 1%, etc., or can be selected from any two of the above percentage ranges. Some non-limiting examples include 0.1%–0.6%, 0.1%–0.5%, 0.1%–0.2%, 0.05%–0.15%, 0.1%–0.8%, etc.

[0180] In some embodiments, solvent So1 is selected from one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, and toluene, or is a solution or emulsion of one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, and toluene with water, or is water itself. In some embodiments, the alcohol is methanol, ethanol, propanol, or butanol. In some embodiments, the alcohol is any suitable isomer. In some embodiments, the alcohol is methanol, ethanol, propanol, butanol, or an isomer thereof.

[0181] In some embodiments, the solvent So1 has a mass percentage content of 50% to 90% in the coating system containing the hydrophilic polymer in the first aspect of the invention, and may also be selected from any of the following percentages: 50%, 55%, 60%, 65%, 70%, 80%, 82%, 84%, 85%, 86%, 86.5%, 87.2%, 88%, 90%, etc., or may be selected from any range consisting of any two of the above percentages, and some non-limiting examples such as 80% to 90%, 86.5% to 90%, 86% to 90%, 87.2% to 90%, etc.

[0182] In this invention, the mass percentages of the reactive hydrophilic polymer Poly1, the reactive monomer Rm1, and the initiator In1 in the dry weight of the coating system containing the hydrophilic polymer in the first aspect of this invention can be combined in any suitable manner.

[0183] In some embodiments, based on the mass percentage of the coating system containing the hydrophilic polymer in the first aspect of the invention, the reactive hydrophilic polymer Poly1 is 45%–90%, the reactive monomer Rm1 is 9.9%–50%, and the initiator In1 is 0.1%–5%; in some embodiments, the reactive hydrophilic polymer Poly1 is 45%–85%, the reactive monomer Rm1 is 14.5%–50%, and the initiator In1 is 0.5%–5%; in some embodiments, the reactive hydrophilic polymer Poly1 is 47%–80%, and the reactive monomer Rm1 is 19%–4%. In some embodiments, the reactive hydrophilic polymer Poly1 is 70%–90%, the reactive monomer Rm1 is 9.9%–25%, and the initiator In1 is 0.1%–3%; in some embodiments, the reactive hydrophilic polymer Poly1 is 75%–85%, the reactive monomer Rm1 is 14.5%–20%, and the initiator In1 is 0.5%–2%; in some embodiments, the reactive hydrophilic polymer Poly1 is 45%–54%, the reactive monomer Rm1 is 42%–51%, and the initiator In1 is 4%–5%.

[0184] In some embodiments, in the coating system containing the hydrophilic polymer described in the first aspect, the weight ratio of the reactive hydrophilic polymer Poly1, the initiator In1, and the reactive monomer Rm1 is as follows: 45 to 90 parts by weight of the reactive hydrophilic polymer Poly1, 9.9 to 50 parts by weight of the reactive monomer Rm1, and 0.1 to 5 parts by weight of the initiator In1. Examples of the weight parts of the reactive hydrophilic polymer Poly1 include 45, 46, 47, 48, 50, 52, 54, 55, 56, 58, 60, 65, 68, 70, 72, 75, 76, 78, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, and 90 parts by weight, and may also be selected from any range of the aforementioned two weight parts. The reactive monomer Rm1 can be present in weight parts of, for example, 9.9, 10, 11, 12, 13, 14, 14.5, 15, 16, 17, 18, 19, 20, 24, 25, 28, 30, 32, 35, 36, 38, 40, 42, 45, 46, 47, 48, 50 parts, or can be selected from any range of the aforementioned two weight parts. The initiator In1 can be present in weight parts of, for example, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 parts, or can be selected from any range of the aforementioned two weight parts. Reference can also be made to the mass percentage of the coating system containing the hydrophilic polymer in the first aspect of the present invention.

[0185] In this invention, the mass percentages of the reactive hydrophilic polymer Poly1, the reactive monomer Rm1, the initiator In1, and the solvent So1 in the coating system containing the hydrophilic polymer in the first aspect of this invention can be combined in any suitable manner.

[0186] In some embodiments, based on the mass percentage of the coating system containing the hydrophilic polymer in the first aspect of the invention, the reactive hydrophilic polymer Poly1 is 4% to 30%, the reactive monomer Rm1 is 1.9% to 19%, the initiator In1 is 0.05% to 1%, and the solvent So1 is 50% to 90%; in some embodiments, the reactive hydrophilic polymer Poly1 is 5% to 12%, the reactive monomer Rm1 is 2% to 8%, the initiator In1 is 0.1% to 0.6%, and the solvent So1 is 80% to 90%; in some embodiments, the reactive hydrophilic polymer Poly1 is 5% to 8%, the reactive monomer Rm1 is 2% to 5%, the initiator In1 is 0.1% to 0.5%, and the solvent So1 is... The content of O1 is 86.5%–90%; in some embodiments, the reactive hydrophilic polymer Poly1 is 8%–15%, the reactive monomer Rm1 is 1.9%–4.8%, the initiator In1 is 0.1%–0.2%, and the solvent So1 is 80%–90%; in some embodiments, the reactive hydrophilic polymer Poly1 is 6%–10%, the reactive monomer Rm1 is 1%–4%, the initiator In1 is 0.05%–0.15%, and the solvent So1 is 86%–90%; in some embodiments, the reactive hydrophilic polymer Poly1 is 4%–6%, the reactive monomer Rm1 is 4%–6%, the initiator In1 is 0.1%–0.8%, and the solvent So1 is 87.2%–90%.

[0187] In some embodiments, the coating system of the first aspect satisfies one or more of the following characteristics:

[0188] The initiator In1 is selected from one or more of the following initiators: benzoin initiators, 4-benzoyl-1,3-dioxapentane initiators, benzyl ketal, α,α-dialkoxyacetophenone, α-hydroxyalkyl benzophenone, α-aminoalkyl benzophenone, acyl phosphorus oxide, diacyl phosphine oxide, acyl phosphine sulfide, and haloacetophenone initiators.

[0189] The reactive monomer Rm1 has a polymer chain and a plurality of reactive groups F1 covalently linked to the polymer chain; wherein the polymer chain in the reactive monomer Rm1 is selected from one or more structures of the group consisting of: polyether, polyurethane, polyethylene, polypropylene, polyvinyl chloride, polyethylene oxide, polyamide, polyacrylamide, poly(meth)acrylic acid, polyvinyl alcohol, polyethyleneimine, polyester and alkyd copolymer, polypeptide and polysaccharide; the reactive groups F1 in the reactive monomer Rm1 are selected from one or more groups of the group consisting of: carbon-carbon unsaturated bond, -NH2, -CONH2 and -SH; when the reactive monomer Rm1 includes a carbon-carbon unsaturated bond, the reactive monomer Rm1 includes one or more structures of alkenyl, unsaturated ester, unsaturated ether, unsaturated amide and dry alkyd resin;

[0190] The solvent So1 is selected from one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, and toluene, or is a solution or emulsion of one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, and toluene with water, or is water itself.

[0191] In some embodiments, the coating system of the first aspect satisfies one or more of the following characteristics:

[0192] The reactive monomer Rm1 is selected from one or more polyethers modified with multiple carbon-carbon unsaturated bonds; wherein, the polyethers modified with multiple carbon-carbon unsaturated bonds include polyethylene glycol modified with multiple carbon-carbon unsaturated bonds and polytetrahydrofuran modified with multiple carbon-carbon unsaturated bonds.

[0193] The number-average molecular weight of the reactive monomer Rm1 is 600–5000 Da.

[0194] In some embodiments, the coating system of the first aspect satisfies one or more of the following characteristics:

[0195] The reactive monomer Rm1 is polyethylene glycol diacrylate or polyethylene glycol dimethacrylate;

[0196] The number-average molecular weight of the reactive monomer Rm1 is 800–2000 Da.

[0197] In a second aspect of the invention, a two-layer coating system containing a hydrophilic polymer is provided, comprising a topcoat system and a primer system; the topcoat system may be selected from the coating system containing a hydrophilic polymer of the first aspect of the invention.

[0198] The primer system used in the third aspect of the present invention can be appropriately selected from existing primer systems or primer formulations.

[0199] The double-layer coating system provided by the second aspect of the present invention can include the coating system containing hydrophilic polymers in the first aspect of the present invention and any suitable primer system, thereby preparing a double-layer hydrophilic coating with a double-layer structure, which can then be used as a double-layer hydrophilic lubricating layer. The coating system of the first aspect can form the top coating of the hydrophilic lubricating layer, and the primer system can form the bottom coating of the hydrophilic lubricating layer. The double-layer hydrophilic coating can simultaneously achieve high lubricity, low friction and high adhesion.

[0200] In some embodiments, the primer system includes the following components: a reactive hydrophilic polymer Poly2, a reactive monomer Rm2, and further includes an initiator In2 and a solvent (denoted as solvent So2).

[0201] The primer system used may include a reactive hydrophilic polymer Poly2 and a reactive monomer Rm2. Both components have polymerization and crosslinking capabilities, which can further improve the lubricity of the hydrophilic lubricating layer, reduce friction, and enhance the adhesion of the hydrophilic lubricating layer. The primer system containing the reactive hydrophilic polymer Poly2 can form a primer layer with a crosslinked network. After further coating with a primer containing the reactive hydrophilic polymer Poly1, Poly1 can form a polymer network and also form chemical bonds with the primer layer formed by the primer system, thereby further improving the adjustability and controllability of the adhesion of the hydrophilic coating.

[0202] In some embodiments, the primer system comprises the following components: 45-90 parts by weight of the reactive hydrophilic polymer Poly2, 9.9-50 parts by weight of the initiator In2, 0.1-5 parts by weight of the reactive monomer Rm2, and the solvent So2; further, based on 100 parts by weight on a dry weight basis; and even further, the solvent So2 has a mass percentage content of ≥50% in the primer system.

[0203] In this application, "dry weight of the primer system" refers to the sum of the weights of all components except the solvent, unless otherwise specified. The dry weight components of the primer system described in the second aspect may include the reactive hydrophilic polymer Poly2, the reactive monomer Rm2, and the initiator In2. The dry weight components of the primer system can be mixed using solvent at the concentration stated during coating, or a smaller amount of solvent can be used to prepare a concentrated solution for easy storage and transportation, which can then be diluted to the required concentration with additional solvent before use.

[0204] In some embodiments, the reactive monomer Rm2 can undergo intermolecular crosslinking and can also be used as a crosslinking agent. In some preferred embodiments, the reactive monomer Rm2 has a polymer chain and a plurality of reactive groups F2 covalently connected to the polymer chain.

[0205] In some implementations, the initiator In2 can be a Norrish type I initiator or a free radical photoinitiator.

[0206] In some embodiments, the present invention provides a reactive hydrophilic polymer Poly2 with a certain crosslinking ability, comprising hydrophilic polymer chains. In some embodiments, the repeating unit of the hydrophilic polymer chain segment is [ZX], wherein Z can be an alkylene group (such as C...). 1-18 The alkylene group (X) can be -O-, -NH-, or -N(CH3)-, further can be -O- or -NH-, and even further, X can be -O- (corresponding to the polyether segment). Furthermore, the reactive hydrophilic polymer Poly2 also contains two carbon-carbon double bonds. In some embodiments, each of the two carbon-carbon double bonds is independently CH2=CH- or CH2=C(CB)-. 10 )-, where B 10 For H or C 1-6 Alkyl groups, and more specifically, two identical carbon-carbon double bonds. In some embodiments, Poly2 is a linear polyethylene glycol derivative with carbon-carbon double bonds at both ends, and more specifically, a linear polyethylene glycol derivative with acryloyl or methacryloyl groups modified at both ends. In some embodiments, Poly2 is a linear polytetrahydrofuran derivative with double bonds at both ends, and more specifically, a linear polytetrahydrofuran derivative with acryloyl groups (CH2=CH-C(=O)-) or methacryloyl groups (CH2=C(CH3)-C(=O)-) modified at both ends. In some embodiments, Poly2 is a linear polytetrahydrofuran derivative with acrylate groups (CH2=CH-C(=O)O-) or methacrylate groups (CH2=C(CH3)-C(=O)O-) modified at both ends. In some embodiments, Poly2 is a linear polytetrahydrofuran derivative with both ends modified with acrylamide groups (CH2=CH-C(=O)NH-) or methacrylamide groups (CH2=C(CH3)-C(=O)NH-).

[0207] In some embodiments, the degree of polymerization of the repeating unit [ZX] in the reactive hydrophilic polymer Poly2 can be denoted as k.

[0208] In some embodiments, the reactive hydrophilic polymer Poly2 has the general formula structure shown in formula (4).

[0209]

[0210] In equation (4),

[0211] Each X is independently -O-, -NH-, or -N(CH3)-;

[0212] Each Z is independently C1-18 Alkylene;

[0213] L 21 and L 22 Each is independently selected from: non-existent, -C(=O)-, and *-C(=O)NH-; where * points to X;

[0214] B 21 and B 22 Each independently is C 1-18 Alkylene;

[0215] L 31 and L 32 Each can be independently -O- or -NH-;

[0216] B 11 and B 12 Each independently is H or C 1-6 Alkyl groups, which may each be independently H, methyl, ethyl, or C. 3-6 alkyl;

[0217] k is an integer selected from 1 to 220.

[0218] In some implementations, L 31 and L 32 When both are -O-, equation (4) has the structure shown in equation (4a):

[0219]

[0220] In some embodiments, each Z in the same molecule is independently an alkylene group, and may further be independently a C group. 1-18 Alkylene, and further, can independently be C 1-16 Alkylene, and further, can independently be C 1-12 Alkylene, and further, can independently be C 1-10 Alkylene, and further, can independently be C 1-8 Alkylenes (specifically, they can be methylene, ethylene, propylene, butylene, pentylene, hexylene, heptylene, or octylene), and more specifically, they can be independently C10. 1-6 Alkylene (specifically, it can be methylene, ethylene, propylene, butylene, pentylene, or hexylene), and more specifically, it can be independently C10. 1-3 Alkylene (specifically, it can be methylene, ethylene, or propylene). In some embodiments, each Z is independently C. 2-8 Alkylene, which can further be independently C 2-6 Alkylene, which can further be independently C 2-4Alkylene (i.e., can be independently ethylene, propyleneene, or butylene). In some preferred embodiments, each Z is independently -(CH2). q3 -; where q3 is an integer selected from 2 to 18, further selected from 2 to 16 (specifically, it can be 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 or 18), even further selected from 2 to 12, even further selected from 2 to 10, even further selected from 2, 3, 4, 5 or 6; in some embodiments, q3 is 2 or 4; in some embodiments, q3 is 2; in some embodiments, q3 is 4. In some embodiments, each Z is independently methylene, ethylene, propylene, butylene, pentylene, hexylene, heptylene, octylene, nonylene, decylene, undecylene, dodecylene, tridecylene, tetradecylene, pentadecylene, hexadecylene, heptadecanylene, or octadecylene. In some embodiments, each Z is independently methylene, 1,2-ethylene, 1,3-propylene, 1,4-butylene, 1,5-pentylene, 1,6-hexylene, 1,7-heptylene, or 1,8-octylene. In some preferred embodiments, Z is -CH2CH2- (i.e., 1,2-ethylene). In some preferred embodiments, Z is 1,4-butylene. In the embodiments described herein, the Z in the same molecule may all be the same.

[0221] In some embodiments, each X can be independently -O-, -NH-, or -N(CH3)-, further X can be independently -O- or -NH-, and even further, X can be -O-. In some preferred embodiments, X is -O- or -NH-. In this case, each Z can be the same or different. In some preferred embodiments, X is -O-. In some preferred embodiments, X is -NH-.

[0222] In some embodiments, the repeating unit [ZX] is -CH2CH2O-, in which case Poly2 contains polyethylene glycol (PEG) segments.

[0223] In some embodiments, the repeating unit [ZX] is -CH2CH2CH2CH2O-, in which case Poly2 contains polytetrahydrofuran (PTMG) segments.

[0224] In some embodiments, k can be an integer selected from 1 to 220. Some non-limiting examples include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 15, 16, 18, 20, 22, 23, 24, 25, 26, 28, 30, 35, 36, 37, 38, 40, 41, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, etc. It can also be an integer range selected from any two of the aforementioned integers, such as 2 to 100, 3 to 65, 4 to 51, 4 to 50, 7 to 24, 7 to 20.

[0225] In some embodiments, the reactive hydrophilic polymer Poly2 contains -(ZX). k The number-average molecular weight of the segments is selected from 500 to 7500 Da, and can also be selected from any of the following molecular weights: 500 Da, 600 Da, 800 Da, 1000 Da, 1100 Da, 1300 kDa, 1500 Da, 1750 Da, 2000 Da, 2200 Da, 2500 Da, 3000 Da, 3300 Da, 3500 Da, 4000 Da, 4400 Da, 4500 Da, 5000 Da, 5500 Da, 6000 Da, 6500 Da, 6600 Da, 7000 Da, 7500 Da, etc., or can be selected from any of the aforementioned molecular weight ranges. Some non-limiting examples include 500–5000 Da, 600–4000 Da, 800–2000 Da, 800–2200 Da, 800–1750 Da, etc.

[0226] In some embodiments, the number average molecular weight of the reactive hydrophilic polymer Poly2 is selected from 500 to 7500 Da, and may also be selected from any of the following molecular weights: 500 Da, 600 Da, 800 Da, 1000 Da, 1100 Da, 1300 kDa, 1500 Da, 1750 Da, 2000 Da, 2200 Da, 2500 Da, 3000 Da, 3300 Da, 3500 Da, 4000 Da, 4400 Da, 4500 Da, 5000 Da, 5500 Da, 6000 Da, 6500 Da, 6600 Da, 7000 Da, 7500 Da, etc., and may also be selected from any of the aforementioned molecular weight ranges. Some non-limiting examples include 500 to 5000 Da, 600 to 4000 Da, 800 to 2000 Da, 800 to 2200 Da, 800 to 1750 Da, etc.

[0227] In some implementations, L 21 and L 22Each is independently selected from: non-existent, -C(=O)-, and *-C(=O)NH-; where * points to X. In the same molecule, L 21 and L 22 They can be the same or different.

[0228] In some implementations, L 21 and L 22 Both are -C(=O)-. At this point, equation (4a) has the structure shown in equation (4b):

[0229]

[0230] In some implementations, L 21 and L 22 All are -C(=O)NH-; where -C(=O)- is connected to X. In this case, equation (4a) has the structure shown in equation (4c):

[0231]

[0232] In some implementations, B in the same molecule 21 and B 22 Each can be an alkylene group independently, and further can be a C group independently. 1-18 Alkylenes, and furthermore, each can independently be C10. 1-16 Alkylenes, and furthermore, each can independently be C10. 1-12 Alkylenes, and furthermore, each can independently be C10. 1-10 Alkylenes, and furthermore, each can independently be C10. 1-8 Alkylenes (specifically, they can be methylene, ethylene, propylene, butylene, pentylene, hexylene, heptylene, or octylene), and further, each can independently be C10. 1-6 Alkylenes (specifically methylene, ethylene, propylene, butylene, pentylene, or hexylene), and further, each can independently be C10. 1-3 Alkylene (specifically, methylene, ethylene, or propylene). In some embodiments, B 21 and B 22 Each can be independently designated as C. 2-8 Alkylenes, which can further be independently C10-C2 ... 2-6 Alkylenes, which can further be independently C10-C2 ... 2-4 Alkylene (i.e., can be ethylene, propyleneene, or butylene independently). In some preferred embodiments, B 21 and B 22 They can each be independently -(CH2) q4-; where q4 is an integer selected from 2 to 18, further selected from 2 to 16 (specifically, it can be 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, or 18), even further selected from 2 to 12, even further selected from 2 to 10, even further selected from 2, 3, 4, 5, or 6; in some embodiments, q4 is 2 or 4; in some embodiments, q4 is 2; in some embodiments, q4 is 4. In some embodiments, B 21 and B 22 Each of these components can be independently methylene, ethylene, propylene, butylene, pentylene, hexylene, heptylene, octylene, nonylene, decylene, undecylene, dodecylene, tridecylene, tetradecylene, pentadecylene, hexadecylene, heptadecanylene, or octadecylene. In some embodiments, B 21 and B 22 Each of these components can be independently methylene, 1,2-ethylene, 1,3-propylene, 1,4-butylene, 1,5-pentylene, 1,6-hexylene, 1,7-heptylene, or 1,8-octylene. In some preferred embodiments, B 21 and B 22 All are -CH2CH2- (i.e., 1,2-ethylidene). In some preferred embodiments, B 21 and B 22 All are 1,4-butylene. In the various embodiments described herein, B in the same molecule 21 and B 22 They can be the same.

[0233] In some implementations, L 31 and L 32 Each independently contains R 02 R 02 It is -O- or -NH-, and R 02 With CH2=C(B 11 )-C(O)- or CH2=C(B 12 The L-C(O)- phase is connected. In some implementations, L 31 and L 32 Each is independently -O- or -NH-. In some implementations, L 31 and L 32 For -O-. In some implementations, L 31 and L 32 It is -NH-.

[0234] In some implementations, B in the same molecule 11 and B 12 Each can be independently H or alkyl, and further can be independently H or C. 1-10Alkyl; furthermore, it can independently be H, methyl, ethyl, or -(CH2). j4 -CH3, j4 is an integer selected from 2 to 9; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl, or decyl; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, or octyl; further, it can independently be H, methyl, ethyl, propyl, butyl, pentyl, or hexyl. In some embodiments, B 11 and B 12 Each can be independently H, methyl, ethyl or C 3-6 Alkyl group. In some preferred embodiments, B 11 and B 12 Each can be independently an alkyl group, and further can each be independently a C group. 1-10 Alkyl; furthermore, each can be independently methyl, ethyl, or -(CH2). j4 -CH3,j4 are integers selected from 2 to 9. In some preferred examples, B 11 and B 12 Each independently is C 1-10 Alkyl group. In some preferred embodiments, B 11 and B 12 Each independently is C 1-8 Alkyl group. In some preferred embodiments, B 11 and B 12 Each independently is C 1-6 Alkyl group (selected from methyl, ethyl, propyl, butyl, pentyl, and hexyl). In some preferred embodiments, B 11 and B 12 Each independently is C 1-3 Alkyl group (specifically methyl, ethyl, or propyl). In some embodiments, B 11 and B 12 Each is independently H or methyl. In some embodiments, B 11 and B 12 Each is independently either H or methyl. In some preferred embodiments, B 11 and B 12 For H. In some preferred examples, B 11 and B 12 It is a methyl group. In the various embodiments described herein, B in the same molecule 11 and B 12 They can be the same.

[0235] In some embodiments, the reactive hydrophilic polymer Poly2 accounts for 45% to 90% of the dry weight of the primer system by mass, and may also be selected from any of the following percentages: 45%, 47%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, etc., or may be selected from any range of two of the above percentages. Some non-limiting examples include 45% to 85%, 47% to 80%, 70% to 90%, 75% to 85%, 45% to 54%, etc.

[0236] In this application, unless otherwise specified, "percentage by mass in the dry weight of the primer system" is based on the dry weight of the primer system as 100%. "Percentage by mass in the primer system" is based on the total weight of the primer system including the solvent as 100%, unless otherwise specified.

[0237] In some embodiments, the reactive hydrophilic polymer Poly2 has a mass percentage content of 4% to 30% in the primer system, and may also be selected from any of the following percentages: 4%, 5%, 6%, 7%, 8%, 9%, 10%, 12%, 15%, 16%, 18%, 20%, 22%, 24%, 25%, 26%, 8%, 30%, etc., or may be selected from any range consisting of any two of the above percentages. Some non-limiting examples include 5% to 12%, 5% to 8%, 8% to 15%, 6% to 10%, 4% to 6%, etc.

[0238] In this invention, the reactive monomer Rm2 is capable of intermolecular crosslinking. In some embodiments, the reactive monomer Rm2 can also act as a crosslinking agent. In some embodiments, the reactive monomer Rm2 has a polymer chain and a plurality (≥2 or ≥3) reactive groups F2 covalently linked to the polymer chain. In some embodiments, the polymer chain in the reactive monomer Rm2 is selected from one or more structures of the group consisting of: polyether, polyurethane, polyethylene, polypropylene, polyvinyl chloride, polyethylene oxide, polyamide, polyacrylamide, poly(meth)acrylic acid, polyvinyl alcohol, polyethyleneimine, polyester and alkyd copolymers, polypeptides, polysaccharides, etc. In some embodiments, the reactive groups F2 on the main chain side groups of the reactive monomer Rm2 are selected from one or more groups of the group consisting of: carbon-carbon unsaturated bonds, -NH2, -CONH2, and -SH, preferably carbon-carbon unsaturated bonds. When the reactive monomer Rm2 includes carbon-carbon unsaturated bonds, the reactive monomer Rm2 may include one or more structures of alkenyl, unsaturated ester, unsaturated ether, unsaturated amide, and dry alkyd resin. In some embodiments of the invention, the carbon-carbon unsaturated bonds in Rm2 are provided by alkenyl groups. In some embodiments of the invention, the carbon-carbon unsaturated bonds in Rm2 are provided by unsaturated structures selected from the group consisting of unsaturated esters, acrylates, methacrylates, unsaturated ethers, unsaturated amides, etc. In some suitable examples, the reactive monomer Rm2 is a polymer having unsaturated esters, amides, ethers, thiols, or mercapto groups.

[0239] In some embodiments, the reactive monomer Rm2 is selected from one or more polyethers modified with multiple carbon-carbon unsaturated bonds. In some embodiments, the multiple polyethers modified with multiple carbon-carbon unsaturated bonds include polyethylene glycol modified with multiple carbon-carbon unsaturated bonds and polytetrahydrofuran modified with multiple carbon-carbon unsaturated bonds. In some embodiments, the reactive monomer Rm2 is polyethylene glycol diacrylate or polyethylene glycol dimethacrylate. In some embodiments, the reactive monomer Rm2 is polyethylene glycol diacrylate.

[0240] In some embodiments, the number average molecular weight of the reactive monomer Rm2 is about 600 Da to about 10,000 Da, further about 600 Da to about 5,000 Da, and even further about 1,000 Da to about 5,000 Da. The number-average molecular weight of the reactive monomer Rm2 can be selected from any of the following molecular weights: 600Da, 700Da, 800Da, 900Da, 1000Da, 1100Da, 1200Da, 1300Da, 1400Da, 1500Da, 1600Da, 1800Da, 2000Da, 2500Da, 3000Da, 3500Da, 4000Da, 4500Da, 5000Da, 5100Da, 5200Da, 5300Da, 5400Da, 5500Da, 5600Da, 5800Da, 6000Da, etc., or can be selected from any two of the aforementioned molecular weight ranges. Some non-limiting examples include 800Da to 2000Da.

[0241] In some embodiments, the reactive monomer Rm2 accounts for 9.9% to 50% of the dry weight of the primer system by mass, and may also be selected from any of the following percentages: 9.9%, 10%, 14.5%, 15%, 18%, 19%, 20%, 25%, 30%, 35%, 40%, 42%, 45%, 48%, 50%, etc., or may be selected from any range of two of the above percentages. Some non-limiting examples include 14.5% to 50%, 19% to 48%, 9.9% to 25%, 14.5% to 20%, 42% to 50%, etc.

[0242] In some embodiments, the reactive monomer Rm2 has a mass percentage content of 1.9% to 19% in the primer system, and may also be selected from any of the following percentages: 1.9%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 9.9%, 10%, 14.5%, 15%, 18%, 19%, etc., or may be selected from any range consisting of any two of the above percentages. Some non-limiting examples include 2% to 8%, 2% to 5%, 1.9% to 4.8%, 1% to 4%, 4% to 6%, etc.

[0243] In some embodiments, the initiator In2 is a Norrish type I initiator or a free radical photoinitiator, in which case the reaction rate is faster. In some embodiments, the initiator In2 is selected from one or more of the following: benzoin initiators, 4-benzoyl-1,3-dioxapentane initiators, benzyl ketal, α,α-dialkoxyacetophenone, α-hydroxyalkylphenone, α-aminoalkylphenone, acyl phosphorus oxide, diacyl phosphine oxide, acyl sulfide, and haloacetophenone initiators. Examples of initiators In2 ​​include, but are not limited to, the following products: Irgacure 2959 (2-hydroxy-4'-(2-hydroxyethoxy)-2-methylphenylethyl ketone), Irgacure 651 (benzyl dimethyl ketal or 2,2-dimethoxy-1,2-diphenyl ethyl ketone), Irgacure 184 (1-hydroxy-cyclohexyl-phenyl ketone as the active component), etc. Initiator In2 can be a single initiator or a combination of multiple initiators.

[0244] In some embodiments, the initiator In2 accounts for 0.1% to 5% of the dry weight of the primer system, and may also be selected from any of the following percentages: 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.2%, 1.5%, 1.6%, 1.8%, 1.9%, 2%, 2.2%, 2.4%, 2.5%, 2.6%, 2.8%, 3%, 3.2%, 3.5%, 3.6%, 4%, 4.5%, 4.8%, 5%, etc., or may be selected from any range of two of the above percentages. Some non-limiting examples include 0.5% to 5%, 0.9% to 5%, 0.1% to 3%, 0.5% to 2%, 4% to 5%, etc.

[0245] In some embodiments, the initiator In2 has a mass percentage content of 0.05% to 1% in the primer system, and may also be selected from any of the following percentages: 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.12%, 0.15%, 0.16%, 0.18%, 0.2%, 0.22%, 0.24%, 0.25%, 0.26%, 0.28%, 0.3%, 0.32%, 0.35%, 0.36%. 0.38%, 0.4%, 0.42%, 0.45%, 0.48%, 0.5%, 0.55%, 0.6%, 0.65%, 0.7%, 0.75%, 0.8%, 0.85%, 0.9%, 0.95%, 1%, etc., or can be selected from any two of the above percentage ranges. Some non-limiting examples include 0.1% to 0.6%, 0.1% to 0.5%, 0.1% to 0.2%, 0.05% to 0.15%, 0.1% to 0.8%, etc.

[0246] In some embodiments, the solvent So2 is selected from one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, and toluene, or is a solution or emulsion of one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, and toluene with water, or is water itself. In some embodiments, the alcohol is methanol, ethanol, propanol, or butanol. In some embodiments, the alcohol is any suitable isomer. In some embodiments, the alcohol is methanol, ethanol, propanol, butanol, or an isomer thereof.

[0247] In some embodiments, the mass percentage of solvent So2 in the primer system is 50% to 90%, and may also be selected from any of the following percentages: 50%, 55%, 60%, 65%, 70%, 80%, 82%, 84%, 85%, 86%, 86.5%, 87.2%, 88%, 90%, etc., or may be selected from any range consisting of any two of the above percentages. Some non-limiting examples include 80% to 90%, 86.5% to 90%, 86% to 90%, 87.2% to 90%, etc.

[0248] In this invention, the mass percentages of the reactive hydrophilic polymer Poly2, the reactive monomer Rm2, and the initiator In2 in the dry weight of the primer system can be combined in any suitable manner.

[0249] In some embodiments, the reactive hydrophilic polymer Poly2 comprises 45%–90% by mass percentage in the dry weight of the primer system, the reactive monomer Rm2 comprises 9.9%–50% by mass, and the initiator In2 comprises 0.1%–5% by mass percentage; in some embodiments, the reactive hydrophilic polymer Poly2 comprises 45%–85% by mass, the reactive monomer Rm2 comprises 14.5%–50% by mass, and the initiator In2 comprises 0.5%–5% by mass percentage; and in some embodiments, the reactive hydrophilic polymer Poly2 comprises 47%–80% by mass, the reactive monomer Rm2 comprises 19%–48% by mass percentage, and the initiator In2 comprises 0.1%–5% by mass percentage. In some embodiments, the reactive hydrophilic polymer Poly2 is 0.9%–5%; in some embodiments, the reactive monomer Rm2 is 70%–90%, the reactive monomer Rm2 is 9.9%–25%, and the initiator In2 is 0.1%–3%; in some embodiments, the reactive hydrophilic polymer Poly2 is 75%–85%, the reactive monomer Rm2 is 14.5%–20%, and the initiator In2 is 0.5%–2%; in some embodiments, the reactive hydrophilic polymer Poly2 is 45%–54%, the reactive monomer Rm2 is 42%–51%, and the initiator In2 is 4%–5%.

[0250] In some embodiments, in the primer system of the second aspect, the weight ratio of the reactive hydrophilic polymer Poly2, the initiator In2, and the reactive monomer Rm2 is as follows: 45 to 90 parts by weight of the reactive hydrophilic polymer Poly2, 9.9 to 50 parts by weight of the reactive monomer Rm2, and 0.1 to 5 parts by weight of the initiator In2. Examples of the weight parts of the reactive hydrophilic polymer Poly2 are 45, 46, 47, 48, 50, 52, 54, 55, 56, 58, 60, 65, 68, 70, 72, 75, 76, 78, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, and 90 parts by weight, and may also be selected from any range of the aforementioned two weight parts. The reactive monomer Rm2 can be present in weight parts of, for example, 9.9, 10, 11, 12, 13, 14, 14.5, 15, 16, 17, 18, 19, 20, 24, 25, 28, 30, 32, 35, 36, 38, 40, 42, 45, 46, 47, 48, and 50 parts, or can be selected from any range consisting of any two of the aforementioned weight parts. The initiator In2 can be present in weight parts of, for example, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, and 5 parts, or can be selected from any range consisting of any two of the aforementioned weight parts. The aforementioned mass percentage in the dry weight of the primer system can also be referenced.

[0251] In this invention, the mass percentages of the reactive hydrophilic polymer Poly2, the reactive monomer Rm2, the initiator In2, and the solvent So2 in the primer system of the second aspect of this invention can be combined in any suitable manner.

[0252] In some embodiments, the reactive hydrophilic polymer Poly3 comprises 4%–30% by mass percentage in the primer system, the reactive monomer Rm3 comprises 1.9%–19%, the initiator In3 comprises 0.05%–1%, and the solvent So2 comprises 50%–90%; in some embodiments, the reactive hydrophilic polymer Poly1 comprises 5%–12%, the reactive monomer Rm1 comprises 2%–8%, the initiator In2 comprises 0.1%–0.6%, and the solvent So2 comprises 80%–90%; in some embodiments, the reactive hydrophilic polymer Poly2 comprises 5%–8%, the reactive monomer Rm2 comprises 2%–5%, the initiator In2 comprises 0.1%–0.5%, and the solvent So2 comprises 86.5%. %–90%; in some embodiments, the reactive hydrophilic polymer Poly2 is 8%–15%, the reactive monomer Rm2 is 1.9%–4.8%, the initiator In2 is 0.1%–0.2%, and the solvent So2 is 80%–90%; in some embodiments, the reactive hydrophilic polymer Poly2 is 6%–10%, the reactive monomer Rm2 is 1%–4%, the initiator In2 is 0.05%–0.15%, and the solvent So2 is 86%–90%; in some embodiments, the reactive hydrophilic polymer Poly2 is 4%–6%, the reactive monomer Rm2 is 4%–6%, the initiator In2 is 0.1%–0.8%, and the solvent So2 is 87.2%–90%.

[0253] In some embodiments, the primer system of the second aspect satisfies one or more of the following characteristics:

[0254] The reactive monomer Rm2 has a polymer chain and a plurality of reactive groups F2 covalently linked to the polymer chain; wherein, the polymer chain in the reactive monomer Rm2 is selected from one or more structures of the group consisting of: polyether, polyurethane, polyethylene, polypropylene, polyvinyl chloride, polyethylene oxide, polyamide, polyacrylamide, poly(meth)acrylic acid, polyvinyl alcohol, polyethyleneimine, polyester and alkyd copolymer, polypeptide and polysaccharide; the reactive groups F2 in the reactive monomer Rm2 are selected from one or more groups of the group consisting of: carbon-carbon unsaturated bond, -NH2, -CONH2 and -SH; when the reactive monomer Rm2 includes a carbon-carbon unsaturated bond, the reactive monomer Rm2 includes one or more structures of alkenyl, unsaturated ester, unsaturated ether, unsaturated amide and dry alkyd resin;

[0255] The initiator In2 is selected from one or more solvents selected from benzoin initiators, 4-benzoyl-1,3-dioxapentane initiators, benzyl ketal, α,α-dialkoxyacetophenone, α-hydroxyalkyl benzophenone, α-aminoalkyl benzophenone, acyl phosphorus oxide, diacyl phosphine oxide, acyl phosphine sulfide, and haloacetophenone initiators.

[0256] So2 is selected from one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, and toluene, or is a solution or emulsion of one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane, and toluene with water, or is water.

[0257] In some embodiments, the reactive monomer Rm2 is selected from one or more polyethers modified with multiple carbon-carbon unsaturated bonds; wherein the multiple polyethers modified with multiple carbon-carbon unsaturated bonds include polyethylene glycol modified with multiple carbon-carbon unsaturated bonds and polytetrahydrofuran modified with multiple carbon-carbon unsaturated bonds.

[0258] Furthermore, the number-average molecular weight of the reactive monomer Rm2 is 600–5000 Da, and even more specifically, it can be 800–2000 Da.

[0259] In some embodiments, the reactive monomer Rm2 is polyethylene glycol diacrylate or polyethylene glycol dimethacrylate;

[0260] Furthermore, the number-average molecular weight of the reactive monomer Rm2 is 600–5000 Da, and even more specifically, 800–2000 Da.

[0261] In a third aspect of the invention, a hydrophilic coating is provided, which can be prepared from a coating system containing a hydrophilic polymer as described in the first aspect of the invention, or from a two-layer coating system containing a hydrophilic polymer as described in the second aspect of the invention. This hydrophilic coating can serve as a top coating layer for a hydrophilic lubricating layer.

[0262] In some embodiments, the hydrophilic coating is laminated on the surface of the medical device; in some embodiments, the hydrophilic coating may be laminated on the surface of the plastic substrate of the medical device; in some embodiments, the medical device may be an implantable medical device.

[0263] In some embodiments of the present invention, the hydrophilic coating may be laminated on the surface of an implantable medical device; further, the hydrophilic coating may be laminated on the surface of a plastic substrate of an implantable medical device.

[0264] In this invention, unless otherwise specified, the term "surface" in "surface of medical device (e.g., surface of plastic substrate)" and "surface of implantable medical device (e.g., surface of plastic substrate)" includes at least the surface that may come into contact with or rub against the tissue in the implantation site.

[0265] In this invention, unless otherwise stated, "implantable medical device" can be used as an implantable medical device, but it is also permitted to be used as a non-implantable medical device.

[0266] In some embodiments, a hydrophilic coating with a single-layer structure (which can serve as a hydrophilic lubricating layer with a single-layer structure) is prepared by using the coating system containing a hydrophilic polymer according to the first aspect of the present invention, or a hydrophilic coating with a double-layer structure (which can serve as a hydrophilic lubricating layer with a double-layer structure) is prepared by combining it with any suitable primer system.

[0267] In some embodiments, a hydrophilic coating with a bilayer structure is prepared from the hydrophilic polymer-containing bilayer coating system according to the second aspect of the present invention, which can be used as a hydrophilic lubricating layer with a bilayer structure.

[0268] The aforementioned single-layer hydrophilic coating can be obtained by the following preparation method: applying the coating system containing hydrophilic polymer described in the first aspect to the surface of a substrate and drying it to form a single-layer hydrophilic coating.

[0269] The aforementioned hydrophilic coating with a double-layer structure can be obtained by the following preparation method: first, a primer system is applied to the surface of a substrate to form a primer coating layer, which is then dried to form a primer layer. Then, a topcoat system (including but not limited to the coating system containing hydrophilic polymers described in the first aspect of this invention) is applied to the surface of the primer coating layer to form a topcoat coating layer, which is then dried to form a topcoat layer, thereby obtaining a hydrophilic coating with a double-layer structure (which can serve as a hydrophilic lubricating layer with a double-layer structure). During the preparation process, reactive groups (including but not limited to carbon-carbon double bonds) in the topcoat coating layer can form chemical bonds with residual reactive groups (including but not limited to double bonds) in the primer coating layer, thereby forming a strong chemical connection between the primer coating layer and the topcoat layer.

[0270] In a fourth aspect of the invention, the application of the coating system containing hydrophilic polymers described in the first aspect of the invention, or the bilayer coating system containing hydrophilic polymers described in the second aspect of the invention, in the preparation of a hydrophilic lubricating layer for a medical device is provided; or the application of the hydrophilic coating described in the third aspect of the invention as a hydrophilic lubricating layer for a medical device is provided.

[0271] The hydrophilic coatings made from the aforementioned hydrophilic polymer-containing coating systems and the aforementioned hydrophilic polymer-containing bilayer coating systems can both be used as hydrophilic lubricating layers for medical devices, including but not limited to hydrophilic lubricating layers on the surface of implantable medical devices. They exhibit good lubrication, low friction, and high adhesion. When used as hydrophilic lubricating layers on the surface of implantable medical devices, they can solve or significantly alleviate the problem that existing implantable medical devices easily rub against body tissues during removal, causing patients to experience burning and pain, and easily leading to tissue damage and adhesion, resulting in complications.

[0272] The coating system and double-layer coating system of the present invention containing hydrophilic polymers are applicable to different substrates, and furthermore, they can provide better adhesion to plastic substrates.

[0273] In some embodiments, the hydrophilic coating is formed on the surface of the medical device; in some embodiments, the hydrophilic coating may be formed on the surface of the plastic substrate of the medical device; in some embodiments, the medical device may be an implantable medical device.

[0274] In some embodiments of the present invention, the hydrophilic coating is formed on the surface of an implantable medical device; further, the hydrophilic coating is formed on the surface of a plastic substrate of the implantable medical device.

[0275] In some embodiments of the present invention, the substrate to which the hydrophilic coating is applied is a plastic substrate. Suitable plastic substrates include, but are not limited to: nylon, PEBAX (block polyetheramide resin product), PU (polyurethane), PET (polyethylene terephthalate), PVC (polyvinyl chloride), PMMA (polymethyl methacrylate), PEEK (polyetheretherketone), PDMS (polydimethylsiloxane), PE (polyethylene), PP (polypropylene), PTFE (polytetrafluoroethylene), etc.

[0276] It should be understood that the term "medical device" as used in this article can refer to an independent medical device product, or a component or part of a structure of a medical device product.

[0277] In some embodiments of the present invention, examples of medical devices include, but are not limited to: tubes (such as catheters, drainage tubes, shunts, cannulas, ear tubes), stents, connectors, patches, electrodes, leads, sutures, medical needles, wires, sensors, angioplasty balls, sleeves, blood oxygenation generators, heart valves, surgical clips, surgical staples, pacemakers, implantable fibrillation devices, medical pumps (such as implantable drug pumps), vertebral cages, artificial intervertebral discs, artificial lenses, etc.

[0278] In some implementations, any of the aforementioned medical devices may be implantable medical devices involved in minimally invasive surgery.

[0279] In a fifth aspect of the invention, a method for preparing a reactive hydrophilic polymer is provided, which can prepare the reactive hydrophilic polymer Poly1 in the coating system containing the hydrophilic polymer described in the first aspect of the invention.

[0280] In some embodiments, the reactive hydrophilic polymer Poly1 is prepared from the hydrophilic polymer poly with the structure shown in formula (6) and the small molecule compound SM with the structure shown in formula (7).

[0281]

[0282] In equation (7), the definitions of B1 and B2 are consistent with those described above;

[0283] R 21 and R 22 All are reactive groups, and R 21 and R 22 For functional group pairs capable of coupling reactions, further, R 21 and R 22 Capable of undergoing coupling reactions to form valence linkers L; m, n, R1, Al, L 11 A2, L, B2, L 13 Suitable combinations of any parameter or any combination of parameters in B1 can be defined as in any implementation or embodiment herein; "*" indicates a site connected to the end base.

[0284] Furthermore, SM overfeeds relative to the repeating unit U3, causing all R... 21 All are grafted with the small molecule compound SM shown in formula (7).

[0285] In some implementations, R 21 and R 22 The groups can be carboxyl groups (-COOH), activated carboxyl groups (such as succinimide carboxylate (-C(O)NHS)), carboxyl hydrohalides (-COOH·HX, where X is a halogen group, such as F, Cl, Br, or I), acyl halides (-C(=O)X, where X is a halogen group, such as Cl or Br), activated carbonate groups (such as succinimide carbonate (-OC(O)NHS)), amino groups (-NH2), hydroxyl groups (-OH), mercapto groups (-SH), aldehyde groups (-CHO), isocyanate groups (-NCO), halogen groups (such as F, Cl, Br, or I), etc. In some embodiments, R 21 and R 22 The combination of -OH with a carboxyl group, a carboxyl hydrohalate, an acyl halide, an isocyanate group, or a halogen group can undergo coupling reactions to generate an ester group (-COO- or -OC(=O)-), an ester group, an ester group, a carbamate group (-NHCOO- or -OC(=O)NH-)), or an ether bond (-O-). In some embodiments, R21 and R 22 Combinations of -NH2 with carboxyl groups, activated carboxyl groups, carboxyl hydrohalides, acyl halides, activated carbonate groups, isocyanate groups, or halogen groups (such as F, Cl, Br, or I) can undergo coupling reactions to generate amide groups (-CONH- or -NHC(=O)-), amide groups, amide groups, amide groups, urethane groups (-NHCOO- or -OC(=O)NH-), urea groups (-NHC(=O)NH-), or divalent amino groups (-NH-). In some embodiments, R 21 For -OH or -NH2, further, R 22 It can be -NCO. In some embodiments, R 21 For -OH, R 22 For -NCO. In some embodiments, R 22 For -OH, R 21 The values ​​are -NCO. The conditions for coupling reactions of these functional groups are well known to those skilled in the art and will not be described further here.

[0286] In some embodiments, the small molecule compound SM is an isocyanate alkyl methacrylate (IEM), where B1 is methyl and L... 13 B2 is -O-, B2 is alkylene, R 22 It is -NCO.

[0287] In some embodiments, the small molecule compound SM is isocyanate methacrylate (IEM), where B1 is methyl and L... 13 B2 is -O-, B2 is 1,2-ethylene, R 22 It is -NCO.

[0288] In some embodiments, the reactive hydrophilic polymer Poly1 is copolymerized from monomers M1 and M3, and further, by random copolymerization. Monomer M3 can be as shown in any of the structures M3a, M3b, M3c, M3d, and M3e. R1, A1, L 11 A2, R 21 Any parameter or suitable combination of parameters may be defined as in any embodiment or example herein. In some embodiments, M1 is vinylpyrrolidone. In some embodiments, M3 is hydroxyalkyl methacrylate, such as in formula M3e where A2 is alkylene. In some embodiments, M3 is hydroxyalkyl methacrylate, such as in formula M3e where A2 is 1,2-ethylene. In some embodiments, M1 is vinylpyrrolidone and M3 is hydroxyalkyl methacrylate. The feed amounts of M1 and M3 can be rationally selected based on the degree of polymerization and ratio of repeating units (e.g., U1 and U2) in the target copolymer. In some embodiments, the feed ratio of M1 to M3 is m:n.

[0289]

[0290] In some embodiments, the reactive hydrophilic polymer Poly1 can be obtained by copolymerization of monomers M1 and M2. Further, the molar ratio of monomers M1 and M2 is m:n. Wherein, R1, A1, L... 11 A2, L, B2, L 13 B1, (m:n) refer to the aforementioned definitions. When L 11 and L 13 When A1 and B1 are -O-, the structure of M2 is as shown in M2a. When A1 and B1 are methyl groups, the structure of M2 is as shown in M2b. In some embodiments, the structure of M2 is as shown in M2c. In some embodiments, the structure of M2 is as shown in M2d. In some embodiments, the structure of M2 is as shown in M2e.

[0291]

[0292] In this invention, the hydrophilic polymer Poly and the reactive hydrophilic polymer Poly1 can each be independently tested for molecular weight using appropriate methods such as gel permeation chromatography (GPC) and matrix-assisted laser desorption / ionization time-of-flight mass spectrometry (MALDI-TOF), and can also be combined with proton nuclear magnetic resonance (NMR) spectroscopy. 1 Appropriate methods such as 1H NMR, Fourier transform infrared spectroscopy (FT-IR), and ultraviolet spectroscopy (UV) can be used for structural identification. Those skilled in the art can confirm whether the target structure has been obtained using conventional analytical methods.

[0293] In a sixth aspect of the invention, a reactive hydrophilic polymer (Poly1) is provided, which may be selected from any reactive hydrophilic polymer Poly1 involved in the first aspect of the invention, or any reactive hydrophilic polymer Poly1 prepared by the preparation method described in the fifth aspect of the invention.

[0294] In some embodiments, the reactive hydrophilic polymer has the structure shown in formula (1), wherein m, n, R1, Al, L 11 A2, L, B2, L 13 B1 can be as defined in any of the embodiments or examples herein; "*" indicates a site connected to the end base.

[0295] In a seventh aspect of the present invention, a method for preparing a reactive hydrophilic polymer is provided, which can prepare the reactive hydrophilic polymer Poly2 in the bilayer coating system containing the hydrophilic polymer described in the second aspect of the present invention.

[0296] In some embodiments, the reactive hydrophilic polymer Poly2 can be coupled to reactive groups R at both ends.41 The modified polyether derivative (LP) is prepared by coupling reaction with a carbon-carbon double bond compound (SM2). In some embodiments, the structure of LP is shown in formula (8), where X, Z, and k can be defined as previously stated. In some embodiments, X is -O-, in which case LP is a polyether diol. In some embodiments, LP is a polytetrahydrofuran diol, X is -O-, and Z is 1,4-butylene. In some embodiments, LP is polyethylene glycol, X is -O-, and Z is 1,2-ethylene. In some embodiments, the carbon-carbon double bond compound (SM2) can have the structure shown in formula (9). Wherein, R 41 and R 42 All are reactive groups, and R 41 and R 42 For functional group pairs capable of coupling reactions (see R above) 21 and R 22 (The functional groups that make up the group), further, R 41 and R 42 Capable of undergoing coupling reactions to form valence linkages L 21 or L 22 B 12 L 31 and B 21 Any parameter or a suitable combination of any parameters may be defined as in any implementation or embodiment herein; "*" indicates a site connected to the end base.

[0297] Unless otherwise stated, in this invention, when LP undergoes a coupling reaction with SM-NCO, SM-NCO is in excess, so that both ends of LP are modified with carbon-carbon double bonds.

[0298]

[0299] In some implementations, R 41 For -NH2. In some preferred embodiments, R 42 It is -OH.

[0300] In some embodiments, R 41 If X is -NH2 and X is -NH-, then the compound of formula (8) is a polyamine.

[0301] In some embodiments, R 41 When X is -OH and X is -O-, the compound of formula (8) is polyethylene glycol.

[0302] In some embodiments, in equation (8), R 41 Z is -NH2 or -OH; Z is alkylene; X is -O- or -NH-.

[0303] In some implementations, R 42It is -NCO.

[0304] In some embodiments, SM2 is ethyl isocyanate methacrylate.

[0305] In some implementations, R 41 For -OH, R 42 It is -NCO.

[0306] In this invention, the molecular weight of the reactive hydrophilic polymer Poly2 can be determined by a suitable method such as gel permeation chromatography (GPC) or matrix-assisted laser desorption / ionization time-of-flight mass spectrometry (MALDI-TOF), and can also be combined with proton nuclear magnetic resonance (NMR) spectroscopy. 1 Appropriate methods such as 1H NMR, Fourier transform infrared spectroscopy (FT-IR), and ultraviolet spectroscopy (UV) can be used for structural identification. Those skilled in the art can confirm whether the target structure has been obtained using conventional analytical methods.

[0307] In an eighth aspect of the invention, a reactive hydrophilic polymer (Poly2) is provided, which may be selected from any reactive hydrophilic polymer Poly2 involved in the second aspect of the invention, or any reactive hydrophilic polymer Poly2 prepared by the preparation method described in the seventh aspect of the invention.

[0308] In some embodiments, the reactive hydrophilic polymer has the structure shown in formula (4), wherein B 11 B 12 L 31 L 32 B 21 B 22 L 21 L 22 X, Z, and k can be as defined in any of the embodiments or examples herein; "*" indicates a site connected to an end base.

[0309] The following are some specific examples.

[0310] The embodiments of the present invention will be described in detail below with reference to examples. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. For experimental methods in the following embodiments where specific conditions are not specified, please refer to the guidelines given in this invention, or follow experimental manuals or conventional conditions in the art, or follow the conditions recommended by the manufacturer, or refer to experimental methods known in the art.

[0311] In the specific embodiments described below, the measurement parameters of the raw materials may have slight deviations within the weighing accuracy range unless otherwise specified. Temperature and time parameters are subject to acceptable deviations due to instrument testing accuracy or operational precision. Unless otherwise specified, the materials or reagents in the following examples are commercially available or prepared by known methods.

[0312] In the following examples, unless otherwise stated,

[0313] IEM: Ethyl isocyanate methacrylate;

[0314] PTMG: Polytetrahydrofuran; PTMG 1000 IEM-PTMG 1000 The numbers in IEM, etc., represent molecular weight, and further, index-average molecular weight;

[0315] PEGDA: Polyethylene glycol (diol) diacrylate; PEGTA: Three-arm polyethylene glycol (triol) triacrylate; PEGDA 800 PEGDA 2000 PEGDA 5000 PEGDA 5000 PEGTA 3000 PEGTA 2400 IEM-PEG 2000 The numbers in IEM, etc., represent molecular weight, and further, index-average molecular weight;

[0316] HEMA: Hydroxyethyl methacrylate;

[0317] BPO: Benzoyl peroxide;

[0318] VP: Vinylpyrrolidone; that is, NVP: N-vinylpyrrolidone;

[0319] Methanol-d4: Deuterated methanol;

[0320] PEBAX: Block polyether amide resin.

[0321] Unless otherwise specified, "store in the dark at low temperature" refers to storage under light-protected conditions at ≤4℃. "Store in the dark at room temperature" unless otherwise specified refers to storage under light-protected conditions at 20–30℃. Unless otherwise specified, reactive monomers should be stored in the dark at low temperature, and coating systems should be stored in the dark at room temperature.

[0322] 1 The H NMR detection conditions are as follows (unless otherwise specified): Bruker AVANCE III 400 NMR instrument, 400 MHz scan power.

[0323] Molecular weight determination method: Gel permeation chromatography (GPC). Unless otherwise specified, the following instruments and test settings were used: Waters 1515 gel permeation chromatograph, Waters 2414 detector, Agilent PLgel 5μm MIXED-C column, chloroform as mobile phase, flow rate of 1 mL / min, column temperature of 35℃, and polystyrene (PS) as standard.

[0324] Example 1. Synthesis of a reactive hydrophilic polymer P (VP-(HEMA-g-IEM))

[0325] In this example, the compound with the structure shown in formula (S1) is prepared with a monomer ratio of NVP:HEMA = 99:1.

[0326]

[0327] (1) Weigh 5g (approximately 45mmol) of vinylpyrrolidone (NVP) and 59mg (approximately 0.45mmol) of hydroxyethyl methacrylate (HEMA), dissolve them in 100mL of isopropanol, then add 1mg of benzoyl peroxide (BPO), and react in an oil bath at 75℃ for 20h under nitrogen protection. After the reaction is complete, evaporate the isopropanol to dryness using a rotary evaporator, precipitate the product in diethyl ether, and dry it to obtain a white solid P(VP-HEMA) copolymer (P01a), with the structural formula shown in formula (100a).

[0328]

[0329] intermediate product P01a 1 H NMR spectrum as shown Figure 1 As shown. Based on the ratio analysis of the relevant peak areas of the characteristic peaks of the vinylpyrrolidone (NVP) monomer unit (-CH-N-CH2-CH2-CH2-C(=O)-, the characteristic peak of the hydrogen atom adjacent to N is 3.20-3.50ppm) and the characteristic peaks of the characteristic peaks of the hydroxyethyl methacrylate (HEMA) monomer unit (CH3-CC(=O)O-CH2-CH2-OH, the characteristic peak of methyl is 1.10~1.25ppm) in formula (100a), the ratio of the number of NVP and HEMA monomer units in formula (100a) is calculated to be approximately 99:1.

[0330] (2) Dissolve the copolymer P01a (5g) obtained above in 100mL of chloroform. After complete dissolution, slowly add 70mg of isocyanate methacrylate (about 0.45mmol) to it. React for 2h. After the reaction is completed, evaporate chloroform and precipitate the product in diethyl ether. Dry the product to obtain copolymer P (VP-(HEMA-g-IEM)), which is denoted as copolymer P01. The structure is shown in formula (100).

[0331] According to GPC test results, the weight-average molecular weight of product P01 is approximately 11.3 kDa, and the number-average molecular weight is approximately 11.1 kDa.

[0332] Product P01 1 H NMR spectrum as shown Figure 2 As shown, the solvent is Methanol-d4. Based on the ratio of the peak areas of the characteristic peaks of the vinylpyrrolidone (NVP) monomer unit in formula (100) (-CH-N-CH2-CH2-CH2-C(=O)-, the characteristic peak of the hydrogen atom adjacent to N at 3.20-3.50 ppm) and the characteristic peaks of the chemical position of the methacrylate group grafted in this step (-OC(=O)-C(CH3)=CH2, the characteristic peaks of the two hydrogen atoms on the double bond at 5.65 ppm and 6.14 ppm), the m:n ratio in formula (100) is calculated to be approximately 99:1. It can be deduced that the grafting rate of isocyanate ethyl methacrylate is approximately 100%. Combining the molecular weight results obtained from GPC testing, the m in formula (100) is calculated to be approximately 99, and the n is approximately 1.

[0333] Example 2. Synthesis of a reactive hydrophilic polymer P (VP-(HEMA-g-IEM))

[0334] In this example, the compound with the structure shown in formula (100) (as shown in Example 1) has the same monomer unit structure as in Example 1, with a monomer ratio of NVP:HEMA = 19:1.

[0335] (1) Weigh 5 g (approximately 45 mmol) of vinylpyrrolidone (NVP) and 308 mg (approximately 2.37 mmol) of hydroxyethyl methacrylate (HEMA), dissolve them in 100 mL of isopropanol, and then add 8.2 mg of benzoyl peroxide (BPO). React in an oil bath at 75 °C for 20 h under nitrogen protection. After the reaction is complete, evaporate the isopropanol using a rotary evaporator, precipitate the product in diethyl ether, and dry it to obtain a white solid P(VP-HEMA) copolymer (PO2a), with the structural formula shown in formula (100a).

[0336] Based on the ratio analysis of the relevant peak areas of the characteristic peaks of the vinylpyrrolidone (NVP) monomer unit (-CH-N-CH2-CH2-CH2-C(=O)-, the characteristic peak of the hydrogen atom adjacent to N is 3.20-3.50ppm) and the characteristic peaks of the chemical shift of the hydroxyethyl methacrylate (HEMA) monomer unit (CH3-CC(=O)O-CH2-CH2-OH, the characteristic peak of methyl is 1.10~1.25ppm) in formula (100a), the ratio of the number of NVP and HEMA monomer units in formula (100a) is calculated to be approximately 19:1.

[0337] (2) Dissolve the copolymer PO2a (5g) obtained above in 100ml of N,N-dimethylformamide. After complete dissolution, slowly add 367mg of isocyanate methacrylate (about 2.37mmol) dropwise. After reacting for 2h, evaporate chloroform to dryness, precipitate the product in diethyl ether, and dry to obtain copolymer P (VP-(HEMA-g-IEM)), denoted as copolymer PO2, with the structure shown in formula (100).

[0338] According to GPC test results, the weight-average molecular weight of product PO2 is approximately 11.2 kDa, and the number-average molecular weight is approximately 4.48 kDa.

[0339] Based on the ratio of the peak areas of the characteristic peaks of the vinylpyrrolidone (NVP) monomer unit in formula (100) (-CH-N-CH2-CH2-CH2-C(=O)-, the characteristic peak of the hydrogen atom adjacent to N at 3.20-3.50 ppm) and the characteristic peaks of the chemical position of the methacrylate group grafted in this step (-OC(=O)-C(CH3)=CH2, the characteristic peaks of the two hydrogen atoms on the double bond at 5.65 ppm and 6.14 ppm), the m:n ratio in formula (100) is calculated to be approximately 19:1. It can be deduced that the grafting rate of isocyanate methacrylate is approximately 100%. Combined with the molecular weight results obtained from GPC testing, m in formula (100) is calculated to be approximately 38, and n is approximately 2.

[0340] Example 3. Synthesis of a reactive hydrophilic polymer P (VP-(HEMA-g-IEM))

[0341] In this example, the compound with the structure shown in formula (100) (as shown in Example 1) has the same monomer unit structure as in Example 1, with a monomer ratio of NVP:HEMA = 7:3.

[0342] (1) Weigh 5 g (approximately 45 mmol) of vinylpyrrolidone and 2.51 g (approximately 19.3 mmol) of hydroxyethyl methacrylate, dissolve them in 100 mL of isopropanol, then add 74 mg of benzoyl peroxide (BPO), and react in an oil bath at 75 °C for 20 h under nitrogen protection. After the reaction is complete, evaporate the isopropanol to dryness using a rotary evaporator, precipitate the product in diethyl ether, and dry it to obtain the P(VP-HEMA) copolymer, denoted as copolymer PO3a, with the general structural formula shown in formula (100a).

[0343] intermediate product P03a 1 H NMR spectrum as shown Figure 3 As shown. Based on the ratio analysis of the relevant peak areas of the characteristic peaks of the vinylpyrrolidone (NVP) monomer unit (-CH-N-CH2-CH2-CH2-C(=O)-, the characteristic peak of the hydrogen atom adjacent to N is 3.20-3.50ppm) and the characteristic peaks of the characteristic peaks of the hydroxyethyl methacrylate (HEMA) monomer unit (CH3-CC(=O)O-CH2-CH2-OH, the characteristic peak of methyl is 1.10-1.28ppm) in formula (100a), the ratio of the number of NVP and HEMA monomer units in formula (100a) is calculated to be approximately 7:3.

[0344] (2) Dissolve the copolymer PO3a (5g) obtained in the previous step in 100mL of chloroform. After complete dissolution, slowly add 3.9g of isocyanate methacrylate (IEM, about 25.2mmol, excess) dropwise. After reacting for 2h, evaporate the chloroform to dryness, precipitate the product in diethyl ether, and dry it to obtain P(VP-(HEMA-g-IEM)) copolymer, denoted as copolymer PO3, with the structural formula shown in formula (100).

[0345] According to GPC test results, the weight-average molecular weight of product PO3 is approximately 12.6 kDa, and the number-average molecular weight is approximately 4.67 kDa.

[0346] Product P03 1 H NMR spectrum as shown Figure 4As shown (400MHz, Methanol-d4). Based on the ratio of the peak areas of the characteristic peaks of the vinylpyrrolidone (NVP) monomer unit in formula (100) (-CH-N-CH2-CH2-CH2-C(=O)-, the characteristic peak of the hydrogen atom adjacent to N at 3.25-3.50ppm) and the characteristic peaks of the chemical position of the methacrylate group grafted in this step (-OC(=O)-C(CH3)=CH2, the characteristic peaks of the two hydrogen atoms on the double bond at 5.65ppm and 6.14ppm), the m:n ratio in formula (100) is calculated to be approximately 7:3. It can be deduced that the grafting rate of isocyanate ethyl methacrylate is approximately 100%. Combining the molecular weight results obtained from GPC testing, the calculated m in formula (100) is approximately 28 and the n is approximately 12.

[0347] Example 4. Synthesis of a reactive hydrophilic polymer P (VP-(HEMA-g-IEM))

[0348] In this example, the compound with the structure shown in formula (100) (as shown in Example 1) has the same monomer unit structure as in Example 1, and the design parameters of the structure include: monomer ratio NVP:HEMA = 5:5.

[0349] (1) Weigh 5 g (approximately 45 mmol) of vinylpyrrolidone and 5.86 g (approximately 45 mmol) of hydroxyethyl methacrylate, dissolve them in 100 mL of isopropanol, then add 74 mg of phthalimide (BPO), and react in an oil bath at 75 °C for 20 h under nitrogen protection. After the reaction is complete, evaporate the isopropanol to dryness using a rotary evaporator, precipitate the product in diethyl ether, and dry it to obtain the P(VP-HEMA) copolymer, denoted as copolymer PO4a, with the structural formula shown in formula (100a).

[0350] intermediate product P04a 1 H NMR spectrum as shown Figure 5 As shown. Based on the chemical shift characteristic peaks of the vinylpyrrolidone (NVP) monomer unit in formula (100a) (-CH-N-CH2-CH2-CH2-C(=O)-, the characteristic peak of the hydrogen atom adjacent to N is 3.15-3.50 ppm) and the chemical shift characteristic peaks of the hydroxyethyl methacrylate (HEMA) monomer unit (CH3-CC(=O)O-CH2-CH2-OH, the characteristic peak of the methyl group is 1.08-),...

[0351] Based on the ratio analysis of the relevant peak areas (1.26ppm), the ratio of the number of NVP and HEMA monomer units in equation (100a) is approximately 5:5.

[0352] (2) Dissolve the copolymer PO4a (5g) obtained above in 100mL of chloroform. After complete dissolution, slowly add 7.1g of isocyanate methacrylate (IEM, about 45mmol) dropwise. After reacting for 2h, evaporate the chloroform after the reaction is complete. Precipitate the product in diethyl ether and dry it to obtain P(VP-(HEMA-g-IEM)) copolymer, denoted as copolymer PO4, with the structural formula shown in formula (100).

[0353] According to GPC test results, the weight-average molecular weight of product PO4 is approximately 11.66 kDa, and the number-average molecular weight is approximately 4.82 kDa.

[0354] Product P04 1 H NMR spectrum as shown Figure 6 As shown (400MHz, Methanol-d4). Based on the ratio of the peak areas of the characteristic peaks of the vinylpyrrolidone (NVP) monomer unit in formula (100) (-CH-N-CH2-CH2-CH2-C(=O)-, the characteristic peak of the hydrogen atom adjacent to N at 3.25-3.55ppm) and the characteristic peaks of the chemical position of the methacrylate group grafted in this step (-OC(=O)-C(CH3)=CH2, the characteristic peaks of the two hydrogen atoms on the double bond at 5.63ppm and 6.14ppm), the m:n ratio in formula (100) is calculated to be approximately 5:5. It can be deduced that the grafting rate of isocyanate methacrylate is approximately 100%. Combining the molecular weight results obtained from GPC testing, the m in formula (100) is calculated to be approximately 20, and the n is approximately 20.

[0355] Examples of coating system preparation 1-7: Formulation of topcoat system (coating system used to prepare topcoat layer)

[0356] Topcoat system preparation example 1-7: Topcoat system 1-7 was prepared according to the coating system formulation in Table 1-6 using the following topcoat system preparation method:

[0357] (1) According to the formula, add the measured amount of anhydrous ethanol into a container with a magnetic stirrer and turn on the stirrer;

[0358] (2) Add the measured amount of reactive hydrophilic polymer P (VP-(HEMA-g-IEM)) to the container according to the formula, and continue stirring;

[0359] (3) Add the measured amount of reactive monomer Rm1 to the container according to the formula, and stir for 1 hour in the dark after the addition is completed;

[0360] (4) After stirring, add the initiator (according to the formula), stir in the dark for 1 hour, store in the dark at room temperature, and wait for use.

[0361] Example 8 of topcoat system preparation: According to the formulation in Table 8, the reactive monomer PEGDA and photoinitiator were uniformly dissolved in anhydrous ethanol to prepare topcoat system 7, which was stored at room temperature away from light for later use.

[0362] Preparation of topcoat system Example 9-10: According to the formulation in Table 9-10, the reactive hydrophilic polymer P (VP-(HEMA-g-IEM)) and the photoinitiator were uniformly dissolved in anhydrous ethanol to prepare topcoat system 8-9, which was stored at room temperature away from light for later use.

[0363] Table 1. Formulation of Topcoat System 1

[0364]

[0365] Table 2. Formulation of Topcoat System 2

[0366]

[0367] Table 3. Formulation of Topcoat System 3

[0368]

[0369] Table 4. Formulation of Topcoat System 4

[0370]

[0371] Table 5. Formulation of Topcoat System 5

[0372]

[0373] Table 6. Formulation of Topcoat System 6

[0374]

[0375] Table 7. Topcoat System Formulation 7

[0376]

[0377] Table 8. Topcoat System Formulation 8

[0378]

[0379]

[0380] Table 9. Formulation of Topcoat System 9 (without added reactive hydrophilic polymer Poly1)

[0381] Topcoat system raw materials Topcoat system 9 mass percentage reactive monomer Rm1 <![CDATA[PEGDA 1000 ]]> 10％ Initiator (photoinitiator) Irgacure2959 0.1％ solvent Anhydrous ethanol 89.9％

[0382] Table 10. Formulation of Top Coating System 10 (without added reactive monomer Rm1)

[0383]

[0384] Table 11. Formulation of Top Coating System 11 (without added reactive monomer Rm1)

[0385]

[0386] Example 5. Synthesis of IEM-PTMG-IEM

[0387] (1) Weigh 20g of polytetrahydrofuran 1000 (PTMG) 1000 M n Approximately 1000 Da (20 mmol) was dissolved in a 100 mL round-bottom flask and heated to 80 °C in an oil bath under nitrogen protection. Then, 6.2 g (approximately 40 mmol) of isocyanate methacrylate (IEM) was slowly added dropwise. After reacting under nitrogen protection for 3 h, heating was stopped to obtain the colorless and transparent product PO5 (IEM-PTMG-IEM), with the structural formula shown in formula (200), where k is approximately 13.

[0388] Product P05 1 H NMR spectrum as shown Figure 7 As shown (400MHz, solvent: deuterated chloroform). Based on the ratio of the peak areas of the chemical shift characteristic peaks (-OCH2CH2CH2CH2-,4H, 3.30-3.60ppm) and (-OCH2CH2CH2CH2-,4H, 1.50-1.80ppm) of the tetrahydrofuran monomer unit in formula (200) and the chemical position characteristic peaks (-OC(=O)-C(CH3)=CH2,4H, characteristic peaks of the two hydrogen atoms on the double bond, 5.59ppm and 6.12ppm) of the methacrylate groups modified at both ends, it can also be inferred that both ends of the polytetrahydrofuran are modified with methacrylate groups. The molecular weight of product P05 is approximately 1.3kDa.

[0389]

[0390] Example 6. Synthesis of IEM-PEG-IEM

[0391] (1) Weigh 40g of polyethylene glycol 2000 (PEG) 1000 M n Approximately 2000 Da (20 mmol) was dissolved in a 100 mL round-bottom flask and heated to 80 °C in an oil bath under nitrogen protection. Then, 6.2 g (approximately 40 mmol) of isocyanate methacrylate (IEM) was slowly added dropwise. After reacting under nitrogen protection for 3 h, heating was stopped to obtain the colorless and transparent product PO6 (IEM-PEG-IEM), with the structural formula shown in formula (300).

[0392]

[0393] Product P06 was subjected to 1 ¹H NMR analysis was performed at 400 MHz using deuterated chloroform as the solvent. 1 Analysis of the ratio of the peak areas of the chemical shift characteristic peak (-OCH2CH2-, 4H, 3.40-3.80 ppm) of the 1H NMR spectrum and the chemical position characteristic peaks (-OC(=O)-C(CH3)=CH2, 4H, characteristic peaks of the two hydrogen atoms on the double bond, approximately 5.5 ppm and 6.1 ppm) of the ethylene glycol monomer unit in formula (300) at both ends also suggests that methacrylate groups are modified at both ends of the polyethylene glycol. Therefore, the product P06 IEM-PEG 2000 The number-average molecular weight of -IEM is approximately 2.3 kDa.

[0394] Examples of primer system preparation 12-16: Formulation of primer systems (for use in two-layer coating systems)

[0395] Example 12-16 of primer system preparation: The primer system 12-16 was prepared according to the coating system formulation in Table 12-16 using the following primer system formulation method:

[0396] (1) According to the formula, add the measured amount of anhydrous ethanol into a container with a magnetic stirrer and turn on the stirrer;

[0397] (2) Add the measured amount of reactive hydrophilic polymer Poly2 to the container according to the formula, and continue stirring;

[0398] (3) Add the measured amount of reactive monomer Rm2 to the container according to the formula, and stir for 1 hour in the dark after the addition is completed;

[0399] (4) After stirring, add the initiator (according to the formula), stir in the dark for 1 hour, store in the dark at room temperature, and wait for use.

[0400] Example 17 for preparing topcoat system: According to the formulation in Table 17, the reactive monomer PEGDA and photoinitiator were uniformly dissolved in anhydrous ethanol to prepare the basecoat system 17, which was stored at room temperature away from light for later use.

[0401] Example 18 of topcoat system preparation: According to the formulation in Table 18, the reactive hydrophilic polymer IEM-PTMG was applied... 1000 -IEM (prepared in Example 4) and photoinitiator were uniformly dissolved in anhydrous ethanol to prepare topcoat system 18, which was stored at room temperature away from light for later use.

[0402] Table 12.

[0403] Base Coating System Raw Materials Primer system 12 mass percentage Reactive hydrophilic polymer Poly2 IEM-PTMG-IEM (Example 5) 8％ reactive monomer Rm2 <![CDATA[PEGDA 1000 ]]> 2％ Initiator (photoinitiator) Irgacure2959 0.1％ solvent Anhydrous ethanol 89.9％

[0404] Table 13.

[0405] Base Coating System Raw Materials Primer system 13 mass percentage Reactive hydrophilic polymer Poly2 <![CDATA[IEM-PEG 2000 -IEM (Example 6)]]> 8％ reactive monomer Rm2 <![CDATA[PEGDA 1000 ]]> 2％ Initiator (photoinitiator) Irgacure2959 0.1％ solvent Anhydrous ethanol 89.9％

[0406] Table 14.

[0407] Base Coating System Raw Materials Primer system 14 mass percentage Reactive hydrophilic polymer Poly2 IEM-PTMG-IEM (Example 5) 5％ reactive monomer Rm2 <![CDATA[PEGDA 1000 ]]> 5％ Initiator (photoinitiator) Irgacure2959 0.5％ solvent Anhydrous ethanol 89.5％

[0408] Table 15.

[0409] Base Coating System Raw Materials Primer system 15 mass percentage Reactive hydrophilic polymer Poly2 IEM-PTMG-IEM (Example 5) 20％ reactive monomer Rm2 <![CDATA[PEGDA 2000 ]]> 10％ Initiator (photoinitiator) Irgacure2959 0.3％ solvent Anhydrous ethanol 69.7％

[0410] Table 16.

[0411] Base Coating System Raw Materials Primer system 16 mass percentage Reactive hydrophilic polymer Poly2 IEM-PTMG-IEM (Example 5) 30％ reactive monomer Rm2 <![CDATA[PEGTA 2400 ]]> 19％ Initiator (photoinitiator) Irgacure2959 1％ solvent Anhydrous ethanol 50％

[0412] Table 17. Primer System Formulation 17 (without added reactive hydrophilic polymer Poly2)

[0413] Base Coating System Raw Materials Primer system 17 mass percentage reactive monomer Rm1 <![CDATA[PEGDA 1000 ]]> 10％ Initiator (photoinitiator) Irgacure2959 0.1％ solvent Anhydrous ethanol 89.9％

[0414] Table 18. Primer System Formulation 18 (without added reactive monomer Rm2)

[0415] Base Coating System Raw Materials Primer system 18 mass percentage Reactive hydrophilic polymer Poly2 <![CDATA[IEM-PTMG 1000 -IEM (Example 5)]]> 10％ Initiator (photoinitiator) Irgacure2959 0.1％ solvent Anhydrous ethanol 89.9％

[0416] Test Example: Testing of Pipe Coating and Friction in Water

[0417] The topcoat system 1-11 in Table 1-11 is abbreviated as Topcoat 1-11; the primer system in Table 12-18 is abbreviated as Primer 12-18.

[0418] 1. Preparation of a single-layer hydrophilic coating (using a topcoat system)

[0419] Plastic substrate: PEBAX pipe (pipe without hydrophilic coating).

[0420] Preparation method: Using the top coating system of coating examples 1-8 in Table 19, the pipe was immersed in the liquid of the top coating system for 1 min and exposed for 3 min to obtain a pipe with a single layer of hydrophilic coating. The formed hydrophilic coatings are referred to as coatings 1-8 respectively.

[0421] 2. Preparation of a double-layer hydrophilic coating (using a combination of a primer system and a topcoat system)

[0422] Plastic substrate: PEBAX pipe (pipe without hydrophilic coating).

[0423] Preparation method: Using the top coating system and primer system of coating examples 9-19 in Table 19, (1) the pipe was first immersed in the primer system for 1 min and exposed to ultraviolet light for 30 s; (2) then immersed in the top coating system for 1 min and exposed for 3 min to obtain a pipe with a double hydrophilic coating. The formed hydrophilic coatings are referred to as coatings 9-19.

[0424] 3. Comparative Example

[0425] Comparative Example 1: Pipes without hydrophilic coating.

[0426] Comparative Example 2: Commercially available product 1, a two-layer coating system, the primer is composed of water-based polyurethane, photoinitiator and solvent; the top coat is composed of polyvinylpyrrolidone, crosslinking agent, adhesion promoter PAcA, photoinitiator and solvent.

[0427] Comparative Example 3: Commercially available product 2, a two-layer coating system, the primer is composed of polyamide, photoinitiator and solvent; the top coat is composed of polyethylene glycol, crosslinking agent, photoinitiator, adhesion promoter PAcA and solvent.

[0428] Comparative Examples 4-6 employed essentially the same method as Coating Example 1, with the only difference being that Top Coating System 9-11 was used instead of Top Coating System 1. Specifically, Top Coating System 9 did not contain the reactive hydrophilic polymer Poly1, and Top Coating Systems 10-11 did not contain the reactive monomer Rm1.

[0429] Comparative Examples 7-8 employed essentially the same method as Coating Example 8, with the only difference being that primer systems 17-18 were used instead of primer system 12 in Coating Example 9. Specifically, primer system 17 did not contain the reactive hydrophilic polymer Poly2, and primer system 18 did not contain the reactive monomer Rm2.

[0430] Test methods

[0431] The tests for friction, effective repetition count, and firmness are conducted according to the following standards: T / CAMDI 021—2019 Disposable hydrophilic coated guidewires; YY / T 1536-2017 Standard test model for evaluating the sliding performance of non-vascular catheter surfaces; T / CSBME 021-2020 Evaluation method for the lubrication performance of hydrophilic coatings on urinary catheters; and YY 0285.1-2017 Disposable sterile catheters for vascular catheters Part 1: General requirements, etc.

[0432] 1. Friction Test Method: The hydrophilic coating sample guide tube to be tested is first immersed in a constant temperature water bath for 30-60 seconds. After full immersion, a friction force device is used to apply a clamping force of 300g to the guide tube, and the tube is repeatedly lifted and pulled 25 times. During this process, the friction force tester will display the real-time data of the guide tube friction force and record the friction force-displacement curve. The program will automatically generate a data table. The average friction force of the guide tube in each cycle is analyzed and compared from the friction force-displacement curve.

[0433] The average value of the friction force over 25 cycles was calculated and recorded as the test result of the "friction force" of the hydrophilic coating, as shown in Table 18.

[0434] The physical meaning of friction: Average friction reflects the lubrication level of the coating after curing. The smaller the value, the better the lubricity of the coating.

[0435] 2. Effective number of repetitions test: 25 repetitions.

[0436] Using the method described in Part 1, "Friction Test Method", the test was repeated 25 times under the same clamping force.

[0437] 3. Firmness

[0438] The durability refers to the difference between the average friction force of the last three tests and the average friction force of the first three tests out of 25 repeated friction tests.

[0439] The physical meaning of "adhesion": It reflects the durability of the coating. The smaller the difference, the better the coating adhesion.

[0440] Test method: The test shall be conducted using the method described in Part 1, “Friction Test Method”, and repeated at least 25 times under the same clamping force.

[0441] Test Results

[0442] The test results can be found in Table 19.

[0443] Among them, the single-layer hydrophilic coatings prepared using the topcoat system (coating examples 1-8) all exhibited low friction levels and excellent adhesion. Compared to commercially available products (Comparative Examples 2 and 3), they achieved higher coating efficiency while maintaining comparable friction and adhesion.

[0444] The two-layer hydrophilic coatings prepared using both primer and topcoat systems (coating examples 9-18) exhibited low friction levels and excellent adhesion. There was no significant difference compared to commercially available products (Comparative Examples 2 and 3).

[0445] In Comparative Example 1, the pipes that were not modified with the "hydrophilic coating" of this invention had poor lubricity.

[0446] The topcoat system in Comparative Example 4, without the addition of the reactive hydrophilic polymer Poly1, showed poor lubricity and adhesion. This is presumably due to the failure to form a cross-linked coating network that meets the requirements for friction and adhesion.

[0447] In the topcoat systems of Comparative Examples 5-6, no reactive monomer Rm1 was added, and the coatings failed prematurely. This is presumably due to the low degree of cross-linking in the coating network.

[0448] In Comparative Example 7, the primer system without the addition of the reactive hydrophilic polymer Poly2 showed higher friction and poor adhesion. This is presumably due to the lower degree of cross-linking in the coating.

[0449] The primer system in Comparative Example 8, without the addition of reactive monomer Rm2, showed higher friction and poor adhesion. This is presumably due to the lower degree of cross-linking in the coating.

[0450] Table 19.

[0451]

[0452]

[0453] In Table 18, if the number of effective repetitions is less than 25, it means that at this value, the friction force has reached the upper limit of the equipment's range, which is far beyond the friction force level suitable for clinical application.

[0454] The technical features of the above embodiments and examples can be combined in any suitable manner. For the sake of brevity, not all possible combinations of the technical features in the above embodiments and examples are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0455] The above embodiments are merely illustrative of several implementation methods of the present invention, facilitating a detailed and specific understanding of the technical solutions of the present invention, but should not be construed as limiting the scope of protection of the present invention. It should be noted that those skilled in the art can make various modifications and alterations without departing from the concept of the present invention, and these all fall within the scope of protection of the present invention. Furthermore, it should be understood that after reading the above teachings, those skilled in the art can make various alterations or modifications to the present invention, and the equivalent forms obtained also fall within the scope of protection of the present invention. It should also be understood that technical solutions obtained by those skilled in the art based on the technical solutions provided by the present invention through logical analysis, reasoning, or limited experimentation are all within the scope of protection of the appended claims. Therefore, the scope of protection of this patent should be determined by the content of the appended claims, and the specification and drawings can be used to interpret the content of the claims.

Claims

1. A coating system containing a hydrophilic polymer, characterized in that, Based on 100 parts by weight (dry weight), it comprises the following components: 45-90 parts by weight of reactive hydrophilic polymer Poly1, 9.9-50 parts by weight of reactive monomer Rm1, 0.1-5 parts by weight of initiator In1 and solvent So1; The reactive hydrophilic polymer Poly1 has the general structure shown in formula (2); Equation (2); The reactive monomer Rm1 is capable of intermolecular crosslinking; the reactive monomer Rm1 has a polymer chain and a plurality of reactive groups F1 covalently connected to the polymer chain, wherein the reactive groups F1 in the reactive monomer Rm1 are selected from carbon-carbon unsaturated bonds; the reactive monomer Rm1 is selected from one or more polyethylene glycols modified with a plurality of carbon-carbon unsaturated bonds. The initiator In1 is a Norrish type I initiator or a free radical photoinitiator; The solvent So1 has a mass percentage content of ≥50% in the coating system; In equation (2), m is an integer selected from 10 to 50; n is an integer selected from 4 to 30; The ratio of m to n is selected from 1:1 to 8:1 and the number average molecular weight of the reactive monomer Rm1 is 900 to 5000 Da; R1 is ; Each A1 is independently either H or methyl; Each A2 is independently C 2-8 Alkylene; Each L 11 Independently -O- or -NH-; Each R3 is independently -O- or -NH-; Each B2 is independently C 2-8 Alkylene; Each L 13 Independently -O- or -NH-; Each B1 is independently H or methyl; "*" indicates the site where the terminal base is connected.

2. The coating system according to claim 1, characterized in that, Equation (1) satisfies any one or more of the following characteristics: m is an integer selected from 15 to 40; n is an integer selected from 4 to 20; The ratio of m to n is selected from 1:1 to 7:3; Each A2 is independently -(CH2) q1 -; where q1 is an integer selected from 2 to 4; L 11 -O-; L 13 -O-; The number-average molecular weight of the reactive hydrophilic polymer Poly1 is selected from 1.5 kDa to 15 kDa.

3. The coating system according to claim 2, characterized in that, Equation (1) satisfies any one or more of the following characteristics: m is an integer selected from 20 to 28; n is an integer selected from 12 to 20; The ratio of m to n is selected from 1:1 to 7:3; Each A1 is independently a methyl group; Each B1 is independently methyl; Each A2 is independently 1,2-ethylidene; Each B2 is an independent 1,2-ethylidene; The number-average molecular weight of the reactive hydrophilic polymer Poly1 is selected from 3 kDa to 10 kDa.

4. The coating system according to claim 1, characterized in that, It meets one or more of the following characteristics: In the same molecule, A2 is always the same; B2 is always the same; B1 is always the same. In the same molecule, L 11 They are all the same; In the same molecule, L 13 They are all the same; The number-average molecular weight of the reactive hydrophilic polymer Poly1 is selected from 3 kDa to 6 kDa.

5. The coating system according to any one of claims 1 to 4, characterized in that, In the reactive hydrophilic polymer Poly1, each R3 is independently -O-.

6. The coating system according to any one of claims 1 to 4, characterized in that, The reactive hydrophilic polymer Poly1 has the general structure shown in formula (2b): （2b）； Wherein, A1 is methyl, A2 is 1,2-ethylidene, R3 is -O-, B2 is 1,2-ethylidene, and B1 is methyl.

7. The coating system according to any one of claims 1 to 4, characterized in that, It meets one or more of the following characteristics: 2) The number-average molecular weight of the reactive monomer Rm1 is 900 ~ 2000 Da; 3) The initiator In1 is selected from one or more of the following initiators: benzoin initiators, 4-benzoyl-1,3-dioxapentane initiators, benzyl ketal, α,α-dialkoxyacetophenone, α-hydroxyalkyl benzophenone, α-aminoalkyl benzophenone, acyl phosphorus oxide, diacyl phosphine oxide, acyl phosphine sulfide, and haloacetophenone initiators; 4) The solvent So1 is selected from one or more of alcohol, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane and toluene, or is a solution or emulsion of one or more of alcohol, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane and toluene with water, or is water; 5) The reactive hydrophilic polymer Poly1 accounts for 45%~85% of the dry weight of the coating system; 6) The reactive monomer Rm1 accounts for 14.5% to 50% of the dry weight of the coating system; 7) On a dry weight basis, the initiator In1 accounts for 0.5% to 5% of the dry weight of the coating system; 8) The reactive hydrophilic polymer Poly1 accounts for 4% to 30% of the mass percentage in the coating system; 9) The reactive monomer Rm1 has a mass percentage content of 1.9% to 19% in the coating system; 10) The initiator In1 has a mass percentage content of 0.05%~1% in the coating system; 11) The solvent So1 has a mass percentage content of 50% to 90% in the coating system.

8. The coating system according to claim 7, characterized in that, It meets one or more of the following characteristics: The number-average molecular weight of the reactive monomer Rm1 is 900 ~ 1100 Da; The reactive hydrophilic polymer Poly1 accounts for 75-85%~80% of the dry weight of the coating system; The reactive monomer Rm1 accounts for 14.5% to 20% of the dry weight of the coating system. The initiator In1 accounts for 0.5% to 2% of the dry weight of the coating system by mass. The reactive hydrophilic polymer Poly1 has a mass percentage content of 6% to 10% in the coating system. The reactive monomer Rm1 has a mass percentage content of 1% to 4% in the coating system. The initiator In1 has a mass percentage content of 0.05% to 0.15% in the coating system; The solvent So1 has a mass percentage content of 86% to 90% in the coating system.

9. The coating system according to claim 7, characterized in that, It meets one or more of the following characteristics: 1) The reactive monomer Rm1 is polyethylene glycol diacrylate or polyethylene glycol dimethacrylate; 2) The number-average molecular weight of the reactive monomer Rm1 is 900 ~ 1100 Da; 3) The reactive hydrophilic polymer Poly1 accounts for 47%~80% of the dry weight of the coating system; 4) The reactive monomer Rm1 accounts for 19%~48% of the dry weight of the coating system; 5) The initiator In1 accounts for 0.9% to 5% of the dry weight of the coating system by mass; 6) The reactive hydrophilic polymer Poly1 accounts for 5% to 8% of the mass percentage in the coating system; 7) The reactive monomer Rm1 has a mass percentage content of 2%~5% in the coating system; 8) The initiator In1 has a mass percentage content of 0.1% to 0.5% in the coating system; 9) The solvent So1 has a mass percentage content of 86.5%~90% in the coating system.

10. A two-layer coating system containing a hydrophilic polymer, comprising a topcoat system and a primer system; wherein the topcoat system is selected from the coating system containing the hydrophilic polymer according to any one of claims 1 to 9; Based on 100 parts by weight (dry weight), the primer system comprises the following components: 45-90 parts by weight of reactive hydrophilic polymer Poly2, 9.9-50 parts by weight of reactive monomer Rm2, 0.1-5 parts by weight of initiator In2, and solvent So2; the reactive hydrophilic polymer Poly2 accounts for 75%-85% by weight of the dry weight of the primer system; and the reactive monomer Rm2 accounts for 14.5%-20% by weight of the dry weight of the primer system. The reactive hydrophilic polymer Poly2 has the general structure shown in formula (4). Equation (4); The reactive monomer Rm2 is capable of intermolecular crosslinking, and the reactive monomer Rm2 has a polymer chain and a plurality of reactive groups F2 covalently connected to the polymer chain; The initiator In2 is a Norrish type I initiator or a free radical photoinitiator; The solvent So2 has a mass percentage content of ≥50% in the primer system; In equation (4), Each X is independently -O-, -NH-, or -N(CH3)-; Each Z is independently C 1-18 Alkylene; L 21 and L 22 Each is independently selected from: non-existent, -C(=O)-, and *-C(=O)NH-; where * points to X; B 21 and B 22 Each independently is C 1-18 Alkylene; L 31 and L 32 Each can be independently -O- or -NH-; B 11 and B 12 Each can be independently H, methyl, ethyl or C 3-6 alkyl; k is an integer selected from 1 to 220.

11. The double-layer coating system according to claim 10, characterized in that, Equation (4) satisfies one or more of the following characteristics: Each X is independently -O-; Each Z is independently 1,2-ethylidene or 1,4-butylidene; L 21 and L 22 All are *-C(=O)NH-; where * points to X; B 21 and B 22 Each of them independently comprises methylene, 1,2-ethylene, 1,3-propylene, 1,4-butylene, 1,5-pentylene, 1,6-hexylene, 1,7-heptylene, or 1,8-octylene; B 11 and B 12 Each can be independently H or methyl; k is an integer selected from 2 to 100; The number-average molecular weight of the reactive hydrophilic polymer Poly2 is 500 to 5000 Da.

12. The double-layer coating system according to claim 10, characterized in that, k is an integer selected from 4 to 50; The reactive monomer Rm2 has a polymer chain and a plurality of reactive groups F2 covalently linked to the polymer chain; wherein the polymer chain in the reactive monomer Rm2 is selected from one or more structures of the group consisting of: polyether, polyurethane, polyethylene, polypropylene, polyvinyl chloride, polyethylene oxide, polyamide, polyacrylamide, poly(meth)acrylic acid, polyvinyl alcohol, polyethyleneimine, polyester and alkyd copolymer, polypeptide and polysaccharide; the reactive groups F2 in the reactive monomer Rm2 are selected from one or more groups of the group consisting of: carbon-carbon unsaturated bond, -NH2, -CONH2 and -SH; when the reactive monomer Rm2 includes a carbon-carbon unsaturated bond, the reactive monomer Rm2 includes one or more structures of alkenyl, unsaturated ester, unsaturated ether, unsaturated amide and dry alkyd resin; The number-average molecular weight of the reactive monomer Rm2 is 600 ~ 4000 Da; The initiator In2 is selected from one or more of the following initiators: benzoin initiators, 4-benzoyl-1,3-dioxapentane initiators, benzyl ketal, α,α-dialkoxyacetophenone, α-hydroxyalkyl benzophenone, α-aminoalkyl benzophenone, acyl phosphorus oxide, diacyl phosphine oxide, acyl sulfide, and haloacetophenone initiators. The solvent So2 is selected from one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane and toluene, or is a solution or emulsion of one or more of alcohols, acetone, methyl ethyl ketone, tetrahydrofuran, dichloromethane and toluene with water, or is water itself. The initiator In2 accounts for 0.5% to 2% of the dry weight of the primer system; The reactive hydrophilic polymer Poly2 has a mass percentage content of 4% to 30% in the primer system; The reactive monomer Rm2 has a mass percentage content of 1.9% to 19% in the primer system; The initiator In2 has a mass percentage content of 0.05% to 1% in the primer system; The solvent So2 has a mass percentage content of 50% to 90% in the primer system.

13. The double-layer coating system according to claim 12, characterized in that, It meets one or more of the following characteristics: The polymer chain in the reactive monomer Rm2 is selected from polyethylene oxide; k is an integer selected from 7 to 20; The reactive monomer Rm2 is selected from one or more polyethers modified with multiple carbon-carbon unsaturated bonds; wherein, the polyethers modified with multiple carbon-carbon unsaturated bonds include polyethylene glycol modified with multiple carbon-carbon unsaturated bonds and polytetrahydrofuran modified with multiple carbon-carbon unsaturated bonds. The number-average molecular weight of the reactive monomer Rm2 is 800 ~ 2000 Da; The reactive monomer Rm2 is polyethylene glycol diacrylate or polyethylene glycol dimethacrylate; The reactive hydrophilic polymer Poly2 has a mass percentage content of 5% to 8% in the primer system; The reactive monomer Rm2 has a mass percentage content of 2% to 5% in the primer system; The initiator In2 has a mass percentage content of 0.1% to 0.5% in the primer system; The solvent So2 has a mass percentage content of 86.5% to 90% in the primer system.

14. A hydrophilic coating, characterized in that, The coating system containing hydrophilic polymer is prepared according to any one of claims 1 to 9, or according to any one of claims 10 to 13, the double-layer coating system containing hydrophilic polymer is prepared.

15. The application of the coating system containing hydrophilic polymer according to any one of claims 1 to 9 or the bilayer coating system containing hydrophilic polymer according to any one of claims 10 to 13 in the preparation of a hydrophilic lubricating layer for a medical device, or the application of the hydrophilic coating according to claim 14 as a hydrophilic lubricating layer for a medical device.

16. The application according to claim 15, characterized in that, The hydrophilic coating is laminated on the surface of a plastic substrate that can be implanted in a medical device; the substrate coated by the hydrophilic coating is a plastic substrate.

17. The application according to claim 16, characterized in that, The plastic substrate is selected from the group consisting of: nylon, block polyetheramide resin products, polyurethane, polyethylene terephthalate, polyvinyl chloride, polymethyl methacrylate, polyetheretherketone, polydimethylsiloxane, polyethylene, polypropylene, and polytetrafluoroethylene.

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