A coated central venous catheter

Abstract

The present invention provides a central venous catheter with a coating. Specifically, it includes a catheter body, a tip, a connection seat, an extension tube and an extension tube connector. The tip is located at one end of the catheter body, the other end of the catheter body is connected to the connection seat, and the connector is connected to the connection seat through the extension tube. The catheter body is made of polyurethane material. The part of the connection seat close to the catheter body in the cross-section along the length extension direction of the catheter is in an arc shape. An antibacterial coating is formed on the catheter body and the tip. The coating is formed by photocuring a coating composition, and the coating composition contains at least one cationic guanidine salt copolymer and at least one hydrophilic polyurethane. The central venous catheter with a coating of the present invention has good antibacterial effect and has the characteristics of long-term antibacterial and non-toxicity.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a central venous catheter with a coating. Background Art

[0002] As a common medical device, a central venous catheter belongs to a type of intravascular catheter and is placed in a large vein. It is inserted into a patient's vein through a puncture technique, such as the internal jugular vein, for intravenous infusion of the patient. It has been widely used in the diagnosis and treatment of diseases such as central venous pressure monitoring, blood volume maintenance, total parenteral nutrition, injection of rescue drugs and therapeutic drugs, and is particularly suitable for patients who need long-term or multiple infusions of blood and drugs. It can be left in the vein for a long time, which not only avoids the pain caused by repeated venous punctures to the patient, but also greatly facilitates medical staff, reduces medical costs, and has many advantages such as simple operation and convenient use.

[0003] However, the existing central venous catheters also have some problems while providing convenience to doctors and patients. For example, during the catheter indwelling process, it is easy to cause bacterial infections, enabling different types of bacteria to adhere and proliferate on the catheter surface to form a bacterial biofilm, which not only increases the chances of venous infection and phlebitis, thus leading to medical accidents and seriously endangering the patient's life safety, but also greatly limits its application space.

[0004] It is mentioned in CN116334174A that the formation of a biofilm is a mechanism by which bacteria colonize and simultaneously develop resistance to antibacterial drugs. Scanning transmission electron microscopy shows that almost all central venous catheters have microbial colonization embedded in the biofilm matrix. The most common pathogenic bacteria isolated from catheter biofilms are Staphylococcus epidermidis, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterococcus faecalis.

[0005] Most central venous puncture patients are critically ill patients, and the puncture sites are mainly loose connective tissues mainly composed of blood vessels, nerves, and fascia, which are extremely prone to microbial infections, leading to severe catheter-related bloodstream infections. Most of these infections are caused by bacteria on the skin surface proliferating and spreading along the central venous catheter, and then invading into the deep venous blood vessels, resulting in hematogenous dissemination and even septicemia. Once a patient is infected, the condition is critical because most of the pathogenic bacteria are drug-resistant bacteria that cause nosocomial infections. Such bacteria are resistant to multiple antibiotics and are prone to misdiagnosis.

[0006] Preventing the formation of biofilms is a key step in preventing catheter-related infections. The most direct and effective method is to perform surface antibacterial modification on the central venous catheter so that microorganisms cannot adhere, reproduce, and form biofilms on the catheter surface. To solve this problem, some solutions are provided by the prior art: CN107802941B proposes loading anti-infective drugs penicillin or macrolide on the main body of the catheter, but this method will face the problem of bacterial drug resistance; CN111228576A proposes using chlorhexidine as an antibacterial agent, but it has the safety risk of small molecule precipitation. In addition, CN106110471A discloses a method of adding a zirconium phosphate silver-loaded antibacterial masterbatch to the surface layer of the tube body, but silver ions, as heavy metals, are likely to enter the human body and cause risks.

[0007] Therefore, there is an urgent need for a new technology to achieve a long-acting antibacterial and non-toxic antibacterial central venous catheter.

[0008] Solution for solving problems

[0009] In view of the above problems, the present invention provides a central venous catheter with a coating.

[0010] It includes a catheter body, a tip, a connector, an extension tube, and an extension tube joint. The tip is located at one end of the catheter body, the other end of the catheter body is connected to the connector, and the joint is connected to the connector through the extension tube. Among them, the catheter body is made of polyurethane material, and an antibacterial coating is formed on the catheter body and the tip. The antibacterial coating is formed by photocuring a coating composition, and the coating composition is composed of a cationic guanidine salt copolymer and at least one hydrophilic polyurethane.

[0011] Further, the central venous catheter has a single-lumen, double-lumen, or multi-lumen structure. When the central venous catheter has a single lumen, the connector is cylindrical. When the central venous catheter has a double-lumen or multi-lumen structure, the connector has an arc shape in the cross-section along the length extension direction of the catheter near the catheter body part.

[0012] Further, the cationic guanidine salt copolymer is obtained by living radical polymerization of polymerizable guanidine monomers, polymerizable Norrish I-type photosensitive monomers, and polymerizable Norrish II-type photosensitive monomers.

[0013] Further, the polymerizable guanidine monomer has a structure shown in the following general formula (Ⅰ) or general formula (Ⅱ):

[0014] (Ⅰ)

[0015] (Ⅱ)

[0016] Among them, n is selected from integers from 8 to 15, and m is selected from integers from 2 to 6;

[0017] Furthermore, the polymerizable Norrish type I photosensitive monomer is selected from at least one of benzil acrylate, aryl ketone acrylate, and acylphosphine oxide acrylate; the polymerizable Norrish type II photosensitive monomer is selected from at least one of benzophenone acrylate, thioxanthone acrylate, and camphorquinone acrylate; the hydrophilic polyurethane is selected from at least one of waterborne cationic polyurethane, waterborne anionic polyurethane, and waterborne nonionic polyurethane.

[0018] Furthermore, the extension tube joint is made of hard polymer material.

[0019] Furthermore, the tip is a soft tip.

[0020] Furthermore, the catheter body, tip, connection seat, and extension tube are all made of polyurethane material.

[0021] Furthermore, the extension tube is provided with a sliding buckle, and the sliding buckle is made of hard polymer material.

[0022] Furthermore, when the central venous catheter is of a double-lumen or multi-lumen structure, it has a distal lumen, an intermediate lumen, and a proximal lumen.

[0023] Effect of the invention

[0024] 1. The connection seat used in the central venous catheter of the present invention is circular or arc-shaped in the cross-section along the length direction, especially the part close to the catheter body is arc-shaped, and the contact surface with the patient is circular arc-shaped, effectively ensuring safety and comfort during use when contacting the human body, and not easily causing indentation, damage, and friction near the access port.

[0025] 2. The coating composition of the present invention uses guanidine-based cationic groups, which can interact with negatively charged bacterial cells, destroy the structure of the bacterial cell membrane, inhibit the integrity of the cell membrane, thereby causing the death of bacteria, and there will be no problem of drug resistance and it can be used for a long time;

[0026] 3. The guanidine substance in the coating composition of the present invention forms a macromolecular polymer of guanidine salt by copolymerizing with the photosensitive monomer. This macromolecular polymer can be firmly bonded to the substrate surface through covalent bonds of the photosensitive group, and at the same time, a cross-linked structure is formed inside the coating, there will be no problem of small molecule precipitation, and it is safe for the human body;

[0027] 4. The coating composition of the present invention uses hydrophilic polyurethane with good biocompatibility, which can effectively enhance the bonding force between the coating and the polyurethane substrate, greatly enhance the firmness of the coating while ensuring functionality, and avoid other medical injuries caused by coating peeling off;

[0028] 5. The cationic guanidine salt copolymer used in the coating composition of the present invention simultaneously contains Norrish type I photosensitive structure and Norrish type II photosensitive structure, which further improves the firmness between the coating and the substrate and within the coating. Description of the Drawings

[0029] Figure 1 , single-lumen central venous catheter

[0030] Figure 2 , double-lumen central venous catheter

[0031] Figure 3 , multi-lumen central venous catheter

[0032] Figure 4 , arc-shaped connecting seat structure

[0033] Figures 5 - 9 , coating firmness test data Detailed Description of the Invention

[0034] In order to better illustrate the present invention, numerous specific details are given in the following detailed description. Those skilled in the art should understand that the present invention can be implemented without some of these specific details. In other instances, methods, means, equipment, and steps well-known to those skilled in the art are not described in detail so as to highlight the gist of the present invention.

[0035] Unless otherwise defined, the technical and scientific terms used in the present invention have the same meanings as those commonly understood by those of ordinary skill in the technical field to which the present invention belongs.

[0036] In this specification, the numerical range expressed as "numerical value A to numerical value B" refers to the range including the endpoint numerical values A and B.

[0037] In this specification, the meaning expressed by "may" includes both the meaning of performing a certain process and the meaning of not performing a certain process.

[0038] It should be understood that the singular form of the article "a" (corresponding to "a", "an", and "the" in English) used in the specification of this application and the appended claims includes plural objects unless otherwise clearly specified in the text.

[0039] In this specification, the terms "one or some specific / preferred embodiments / schemes", "another or other specific / preferred embodiments / schemes", "one or another embodiment / scheme", "one or another technical scheme", etc. refer to specific elements (e.g., features, structures, properties, and / or characteristics) related to the described embodiment that are included in at least one of the embodiments described herein, and may or may not exist in other embodiments. Additionally, it should be understood that the elements may be combined in any suitable manner in various embodiments.

[0040] The terms "comprise" and any variations thereof in the specification and claims of the present invention are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that comprises a series of steps or units is not limited to the listed steps or units, but optionally further includes steps or units not listed, or optionally further includes other steps or units inherent to these processes, methods, products, or devices.

[0041] Furthermore, the terms "first" and "second" are used only for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the invention, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically defined. In the description of the present invention, the meaning of "several" is at least one, such as one, two, etc., unless otherwise specifically defined.

[0042] In the present invention, the solvent comprises one or more of water, low molecular weight alcohols (such as methanol, ethanol, isopropanol, butanol, pentanol, ethylene glycol, propylene glycol, glycerol, etc.), N,N-dimethylformamide, N,N-dimethylacetamide, dimethyl sulfoxide, acetone, phenol. Preferably, the solvent is one or a mixed solvent capable of dissolving the polymer of the present invention to form a homogeneous solution. Preferably, the solvent is a mixture of water and isopropanol. Further, in order to promote the polymer to form a coating more quickly, the appropriate range of isopropanol in the solvent by weight of the total solvent is 15-70%, more preferably 20-60%, and even more preferably 30-50%. The mass fraction range of the solvent in the coating liquid composition is 60%-99.9%, preferably, the mass fraction range is 80-99%.

[0043] Additive auxiliaries may also be added to the coating liquid composition of the present invention as needed. The auxiliaries include one or more of the following: leveling agents, defoaming agents, film-forming aids, viscosity regulators, pigments, antibacterial agents, colorants, surfactants, etc., pH value regulators, buffer solutions, preservatives, etc., to optimize and adjust the coating base liquid.

[0044] <First Embodiment>

[0045] Referring to Figure 2 , the present invention provides a central venous catheter with an antibacterial coating, including a catheter body 21, a tip 22, a connection seat 23, an extension tube 24 and an extension tube joint 25. The catheter body 21 is made of polyurethane material and is inserted into the human vein during a puncture operation for delivering liquid to the human body. The tip 22 is located at one end of the catheter body 21 and serves as the foremost end inserted into the human body. Preferably, it is a soft tip to avoid damaging the blood vessels. The other end of the catheter body 21 is connected to the connection seat 23, and the joint 25 is connected to the connection seat 23 through the extension tube 24. A guide wire, liquid, etc. enter the catheter body 21 through the extension tube joint 25, the extension tube 24 and the connection seat 23.

[0046] As a preferred embodiment, the catheter body includes a cavity 26. The cavity is mainly used for the circulation of injected liquid. For different usage scenarios, the cavity can be one, two or multiple, such as single - cavity, double - cavity, triple - cavity, quadruple - cavity, quintuple - cavity, etc.

[0047] Preferably, to ensure the use strength of the central venous catheter, when there are two cavities, one cavity is circular and the other is arc - shaped, making the structure of the catheter body more stable.

[0048] When using multiple cavities, they are often divided into a distal cavity, a middle cavity and a proximal cavity. The distal cavity is used for the passage of a guide wire or measuring the central venous pressure, and the middle cavity and the proximal cavity can be respectively used for blood collection, parenteral nutrition solution delivery, drug delivery, etc.

[0049] Preferably, the connection seat 23 is arc - shaped in the cross - section along the length extension direction of the catheter, especially the end close to the catheter body 21 is arc - shaped, and the contact surface with the human body is circular - arc - shaped, effectively ensuring safety and comfort during contact with the human body during use and not easily causing indentations, injuries and frictions near the access port.

[0050] Preferably, the extension tube joint 25 is made of high - molecular hard material, meeting good biocompatibility, mechanical properties, chemical stability, high - temperature resistance and sterilization performance, etc.; Further preferably, the catheter body 21, the tip 22, the connection seat 23 and the extension tube 24 are all made of polyurethane material.

[0051] Preferably, the extension tube 24 has a sliding buckle 27, and the sliding buckle 27 is made of high - molecular hard material, also preferably having good biocompatibility, mechanical properties, chemical stability, high - temperature resistance and sterilization performance, etc.

[0052] Referring to Figure 1 and Figure 3 , they are a single - cavity central venous catheter and a triple - cavity central venous catheter respectively.

[0053] <Second Embodiment>

[0054] The present invention provides a central venous catheter with an antibacterial coating, wherein the catheter body 21 and the tip 22 are provided with an antibacterial coating to minimize infection caused by interventional use. The antibacterial coating is formed by photocuring a coating composition, wherein the coating composition is composed of a cationic guanidine salt copolymer and at least one hydrophilic polyurethane.

[0055] Guanidine antibacterial substances have strong broad-spectrum antibacterial effects and can inhibit the growth of a variety of bacteria, fungi and viruses, especially Gram-negative bacteria (such as Escherichia coli, Pseudomonas aeruginosa) and Gram-positive bacteria (such as Staphylococcus aureus). Guanidine antibacterial substances can interact with negatively charged bacterial cells, destroy the structure of bacterial cell membranes, inhibit the integrity of cell membranes, and thus lead to bacterial death.

[0056] In the present invention, a hydrophilic polyurethane with good biocompatibility is selected and compounded with a cationic guanidine salt copolymer to form an antibacterial coating. As a part of the coating composition, the hydrophilic polyurethane can significantly improve the adhesion and firmness between the coating and the tube body by enhancing the interface affinity with the polyurethane substrate of the tube body, hydrogen bonding, and improving wettability. At the same time, the introduction of the hydrophilic polyurethane can further improve the water phase dispersibility and coating stability of the coating, and avoid cracking or shedding of the coating during the drying process.

[0057] As a preferred embodiment, the cationic guanidine salt copolymer is obtained by polymerizing a polymerizable guanidine monomer, a polymerizable Norrish I type photosensitive monomer, and a polymerizable Norrish II type photosensitive monomer through living free radical polymerization.

[0058] In the present invention, the antibacterial guanidine substance is copolymerized with the photosensitive monomer to form a macromolecular polymer of guanidine salt, which can be firmly bonded to the surface of the substrate through the covalent bond of the photosensitive group, and at the same time form a cross-linked structure inside the coating, avoiding the problem of small molecule precipitation, and is safe for the human body. In addition, the cationic guanidine salt copolymer in the present invention contains both Norrish I type photosensitive structure and Norrish II type photosensitive structure, and the different photoreaction mechanisms of the two photosensitive structures are complemented to further improve the firmness of the coating and the substrate and the inside of the coating.

[0059] In certain preferred methods, the polymerizable guanidine monomer has a structure represented by the following general formula (I) or (II):

[0060] (Ⅰ)

[0061] (Ⅱ)

[0062] Wherein, n is selected from integers from 8 to 15, and m is selected from integers from 2 to 6;

[0063] In some embodiments, the polymerizable guanidine monomer is a compound containing a biguanide group, which is mainly obtained by reacting the biguanide group with a double-bond-containing monomer structure including a desired linking group. Preferably, it can be obtained by a reaction on the biguanide group (such as in General Formula I) or by a reaction on the end group of the biguanide backbone (such as in General Formula II).

[0064] In certain preferred methods, the polymerizable Norrish I type photosensitive monomer is selected from at least one of benzil acrylate, aryl ketone acrylate, and acylphosphine oxide acrylate; the polymerizable Norrish II type photosensitive monomer is selected from at least one of benzophenone acrylate, thioxanthone acrylate, and camphorquinone acrylate; the hydrophilic polyurethane is selected from at least one of aqueous cationic polyurethane, aqueous anionic polyurethane, and aqueous nonionic polyurethane.

[0065] Example Part

[0066] Referring to the above implementation content, in order to make the technical solution of the present application more specific, clear, and easy to understand, the technical solution of the present application is exemplified below. However, it should be noted that the following examples are used to illustrate the present invention, and those skilled in the art can understand that this example is only an illustrative description and not an exhaustive description.

[0067] Example 1:

[0068] Figure 2 A detailed view of the central venous catheter and the coating on the catheter body is shown, and the coating is distributed on the catheter body. As shown in the figure, the present invention provides a central venous catheter with a coating, including a catheter body 21, a tip 22, a connection seat 23, an extension tube 24, and an extension tube joint 25. The catheter body 21 is made of polyurethane material, which is inserted into the human vein during a puncture operation for delivering liquid to the human body. The tip 22 is located at one end of the catheter body 21 and serves as the foremost end inserted into the human body, preferably a soft tip to avoid damaging the blood vessel. The other end of the catheter body 21 is connected to the connection seat 23, and the joint 25 is connected to the connection seat 23 through the extension tube 24. A guide wire, liquid, etc. enter the catheter body 21 through the extension tube joint 25, the extension tube 24, and the connection seat 23. The catheter body 21 includes a cavity 26. The part of the connection seat 23 close to the catheter body 21 in the cross-section along the length direction of the catheter is in an arc shape.

[0069] Preparation Example 1:

[0070] <Synthesis of a Photocurable Cationic Guanidine Salt Copolymer 1>

[0071] Weigh 15 g (6 mmol) of the polymerizable guanidine monomer of general formula (I), 0.15 g (0.3 mmol) of aryl ketone acrylate (Norrish I type photosensitive monomer), 0.3 g (0.5 mmol) of benzophenone acrylate (Norrish II type photosensitive monomer), and 0.077 g (0.5% by mass of the total monomer amount) of azobisisobutyronitrile and add them to a 100 mL round-bottom flask. Add 50 mL of absolute ethanol and dissolve by mechanical stirring. The solution is purged with N 2 for 30 min to remove oxygen. Place the reaction flask in an oil bath at 65 °C and start the reaction. After reacting for 6 h, remove the reaction solution and cool it to room temperature. Precipitate it in absolute ether, and dry the precipitate in an oven at 35 °C in the dark for 36 h. The photocurable cationic guanidine salt copolymer is prepared and denoted as copolymer 1.

[0072] Preparation Example 2:

[0073] <Synthesis of photocurable cationic guanidine salt copolymer 2>

[0074] Weigh 15 g (6 mmol) of the polymerizable guanidine monomer of general formula (II), 0.21 g (0.3 mmol) of benzil acrylate (Norrish I type photosensitive monomer), 0.38 g (0.5 mmol) of thioxanthone acrylate (Norrish II type photosensitive monomer), and 0.077 g (0.5% by mass of the total monomer amount) of azobisisobutyronitrile and add them to a 100 mL round-bottom flask. Add 50 mL of absolute ethanol and dissolve by mechanical stirring. The solution is purged with N 2 for 30 min to remove oxygen. Place the reaction flask in an oil bath at 65 °C and start the reaction. After reacting for 6 h, remove the reaction solution and cool it to room temperature. Precipitate it in absolute ether, and dry the precipitate in an oven at 35 °C in the dark for 36 h. The photocurable cationic guanidine salt copolymer is prepared and denoted as copolymer 2.

[0075] Preparation Example 3:

[0076] <Synthesis of photocurable cationic guanidine salt copolymer 3>

[0077] Weigh 15 g (6 mmol) of the polymerizable guanidine monomer of general formula (I), 0.4 g (0.8 mmol) of aryl ketone acrylate (Norrish I type photosensitive monomer), and 0.077 g (0.5% by mass of the total monomer amount) of azobisisobutyronitrile and add them to a 100 mL round-bottom flask. Add 50 mL of absolute ethanol and dissolve by mechanical stirring. The solution is purged with N 2After deoxygenation for 30 min, place the reaction flask in an oil bath at 65 °C and start the reaction. After reacting for 6 h, remove the reaction solution and cool it to room temperature. Precipitate it in anhydrous ether, and dry the precipitate in an oven at 35 °C in the dark for 36 h. The photocurable cationic guanidine salt copolymer is prepared and denoted as copolymer 3.

[0078] Preparation Example 4:

[0079] <Synthesis of photocurable cationic guanidine salt copolymer 4>

[0080] Weigh 15 g (6 mmol) of the polymerizable guanidine monomer of general formula (I), 0.48 g (0.8 mmol) of benzophenone acrylate (Norrish type II photosensitive monomer), and 0.077 g (0.5% by mass of the total monomer mass) of azobisisobutyronitrile and add them to a 100 mL round-bottom flask. Add 50 mL of anhydrous ethanol and dissolve them by mechanical stirring. The solution is purged with N 2 After deoxygenation for 30 min, place the reaction flask in an oil bath at 65 °C and start the reaction. After reacting for 6 h, remove the reaction solution and cool it to room temperature. Precipitate it in anhydrous ether, and dry the precipitate in an oven at 35 °C in the dark for 36 h. The photocurable cationic guanidine salt copolymer is prepared and denoted as copolymer 3.

[0081] Example 1:

[0082] <Preparation of antibacterial coating composition 1 and curing>

[0083] Weigh 2 g of the above copolymer 1 and 20 g of polyethylene glycol-based waterborne polyurethane acrylate and dissolve them in 95 g of a mixed solvent of deionized water / isopropanol. Stir and dissolve in the dark for 18 h to obtain a colorless and clear coating solution. Wipe the surface of the central venous catheter clean with a lint-free paper dipped in 75% ethanol and let it dry. Immerse the catheter into the cylinder containing the above coating solution, let it stand for 1 min, lift the catheter at a speed of 0.5 cm / s, and irradiate the catheter with the coating solution with a UV lamp for 5 min for curing treatment. The UV light intensity is 10 mW / cm2, and the catheter rotation speed is 4 rpm. The cured sample is placed in the air to dry.

[0084] Example 2:

[0085] <Preparation of antibacterial coating composition 2 and curing>

[0086] The steps are the same as those in Example 1, except that copolymer 1 is replaced with copolymer 2, and hydrophilic polyurethane is replaced with carboxyl water-based poly urethane acrylate.

[0087] Comparative Example 1:

[0088] <Preparation of antibacterial coating composition 3 and curing>

[0089] The steps are the same as those in Example 1, except that copolymer 1 is replaced with copolymer 3.

[0090] Comparative Example 2:

[0091] <Prepare antibacterial coating composition 4 and cure it>

[0092] The steps are the same as those in Example 1, except that copolymer 1 is replaced with copolymer 4.

[0093] Comparative Example 3:

[0094] <Prepare antibacterial coating composition 4 and cure it>

[0095] The steps are the same as those in Example 1, but without hydrophilic polyurethane.

[0096] <Test antibacterial performance>

[0097] Cut the ethylene oxide sterilized catheter into 0.5×0.5 cm samples, place them in a sterile 48-well plate with the coated surface facing up, add 10 μL of bacterial solution with OD600 = 0.01, cover it and place it in a 37°C constant temperature incubator for 3 h. Add 500 μL of liquid medium to soak the samples, shake well and soak for 10 min, collect the bacteria by ultrasound (150 w) for 1 minute (stop for 5 seconds every 10 seconds of ultrasound), serially dilute them by 1:100 and 1:500 and then spread them on plates. Place them in a 37°C constant temperature incubator overnight, take pictures, and count the number of colonies on the plates.

[0098] Verify the antibacterial effects of the catheter against two kinds of bacteria, Escherichia coli (E.coil) and Staphylococcus aureus (S.aureus), use the plate spreading method to count the number of colonies, compare with the uncoated catheter, and verify its antibacterial effect. The test results are shown in the following table.

[0099]

[0100] It can be seen from the experimental data that the antibacterial coating of the present invention has excellent antibacterial performance and can achieve very good antibacterial effects against both Gram-negative bacteria and Gram-positive bacteria. In Comparative Example 1 and Comparative Example 2, due to the lack of photoinitiator and hydrophilic polyurethane respectively, the antibacterial effect of the coating may be reduced due to the decrease in coating binding.

[0101] <Test adhesion performance>

[0102] Firmness tests were conducted on Example 1, Example 2, and Comparative Examples 1-3. The firmness test method referred to TCSBME021-2020 "Evaluation Method for the Lubricating Performance of Hydrophilic Coatings on Catheters": The test was carried out using a friction tester in a water bath environment at (37±2)°C. The tube body was kept vertical, the sample was immersed in water, and the sample was clamped with a silicone sheet with a hardness of (55±2)A. The clamping force was 3N, the running speed was 10mm / s, the immersion time was 60s, the number of friction cycles was 5 times, and the test distance was 100 mm.

[0103] The test results are as Figures 5 - 9 shown.

[0104] It can be seen from the experimental data that the antibacterial coating of the present invention has excellent coating firmness, and the friction coefficient still remains close to the initial state without significant increase after 5 friction cycles. In Comparative Examples 1, 2, and 3, the coating firmness decreased due to the lack of Norrish I type / Norrish II type photoinitiator and hydrophilic polyurethane, respectively, which was specifically manifested as an increase in the friction coefficient with the increase in the number of friction cycles.

Claims

1. A coated central venous catheter, characterized in that: The invention comprises a catheter body, a tip, a connection seat, an extension tube and an extension tube joint, wherein the tip is located at one end of the catheter body, the other end of the catheter body is connected to the connection seat, and the joint is connected to the connection seat through the extension tube; wherein the catheter body is made of polyurethane material, an antibacterial coating is formed on the catheter body and the tip, and the antibacterial coating is formed by photocuring a coating composition, wherein the coating composition is composed of a cationic guanidine salt copolymer and at least one hydrophilic polyurethane, wherein the cationic guanidine salt copolymer is obtained by active free radical polymerization of a polymerizable guanidine monomer, a polymerizable Norrish I type photosensitive monomer and a polymerizable Norrish II type photosensitive monomer; wherein the polymerizable guanidine monomer has a structure represented by the following general formula (I) or general formula (II): (Ⅰ) (Ⅱ) wherein n is selected from an integer of 8-15, and m is selected from an integer of 2-6; Wherein, the polymerizable Norrish I type photosensitive monomer is selected from at least one of benzil acrylate, aryl ketone acrylate and acylphosphine oxide acrylate; The polymerizable Norrish II type photosensitive monomer is selected from at least one of benzophenone acrylate, thioxanthone acrylate and camphorquinone acrylate.

2. The central venous catheter according to claim 1, characterized in that The central venous catheter has a single-lumen structure, and the connecting seat is cylindrical.

3. The central venous catheter according to claim 1, characterized in that: The central venous catheter has a double-lumen or multi-lumen structure, and the connecting seat is in an arc shape near the catheter body in the cross section in the direction of the catheter length extension.

4. The central venous catheter according to any one of claims 1 to 3, characterized in that: The hydrophilic polyurethane is selected from at least one of aqueous cationic polyurethane, aqueous anionic polyurethane and aqueous nonionic polyurethane.

5. The central venous catheter according to any one of claims 1 to 3, characterized in that: The extension pipe joint is made of hard polymer material.

6. The central venous catheter according to any one of claims 1 to 3, characterized in that: The tip is a soft head.

7. The central venous catheter according to any one of claims 1 to 3, characterized in that: The catheter body, tip, connection seat and extension tube are all made of polyurethane.

8. The central venous catheter according to any one of claims 1 to 3, characterized in that: The epitaxial tube is provided with a sliding buckle which is made of a hard polymer material.

9. The central venous catheter according to claim 3, characterized in that: The central venous catheter has a distal lumen, a middle lumen, and a proximal lumen.

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