Central venous catheter with coating

Abstract

The invention provides a central venous catheter with a coating. The catheter specifically comprises a catheter body, a tip, a connecting 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 with the connecting seat, the connector is connected with the connecting seat through the extension tube, and the catheter body is made of polyurethane materials. The part, close to the catheter body, of the section of the connecting base in the length extension direction of the catheter is in an arc shape, antibacterial coatings are formed on the catheter body and the tip end, the coatings are formed by photocuring of a coating composition, and the coating composition at least comprises a cationic guanidine salt copolymer and at least one hydrophilic polyurethane. The central venous catheter with the coating is good in antibacterial effect and has the advantages of being long-acting in antibacterial effect and free of toxicity.

Description

Technical Field

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

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

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

[0004] CN116334174A mentions that biofilm formation is a mechanism by which bacteria colonize and develop resistance to antimicrobial drugs. Scanning transmission electron microscopy shows that almost all central venous catheters are colonized by microorganisms embedded in the biofilm matrix. The most common pathogens isolated from catheter biofilms are Staphylococcus epidermidis, Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterococcus faecalis.

[0005] Most patients who undergo central venous puncture are critically ill, and the puncture site is mostly loose connective tissue, mainly blood vessels, nerves, and fascia, which is very prone to microbial infection, leading to severe catheter-related bloodstream infection. Most of these infections are caused by bacteria on the skin surface proliferating and deriving along the central venous catheter, then invading the deep veins, spreading through the blood, and causing systemic bacteremia or even sepsis. Once a patient is infected, the condition is critical because most pathogens are drug-resistant bacteria that cause nosocomial infections. These bacteria are resistant to multiple antibiotics and are prone to misdiagnosis.

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

[0007] Therefore, there is an urgent need for a new technology to achieve long-lasting antibacterial, non-toxic antibacterial central venous catheters. Summary of the invention

[0008] Solutions for solving problems

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

[0010] 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, and an antibacterial coating is formed on the catheter body and the tip, and 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 structure, the connector is cylindrical. When the central venous catheter has a double-lumen or multi-lumen structure, the connector is an arc-shaped part close to the catheter body in the cross section of the catheter extension direction.

[0012] Furthermore, 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.

[0013] Furthermore, the polymerizable guanidine monomer has a structure represented by the following general formula (I) or (II):

[0014] (Ⅰ)

[0015] (Ⅱ)

[0016] wherein n is selected from an integer of 8-15, and m is selected from an integer of 2-6;

[0017] Furthermore, the polymerizable Norrish I type photosensitive monomer is selected from at least one of benzil acrylate, aromatic 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; and the hydrophilic polyurethane is selected from at least one of waterborne cationic polyurethane, waterborne anionic polyurethane, and waterborne nonionic polyurethane.

[0018] Furthermore, the extension pipe 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.

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

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

[0023] Effects of the Invention

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

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

[0026] 3. The guanidine substance in the coating composition of the present invention 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 a cross-linked structure is formed inside the coating, so that 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 shedding;

[0028] 5. The cationic guanidine copolymer used in the coating composition of the present invention comprises both a Norrish I-type photosensitive structure and a Norrish II-type photosensitive structure, thereby further improving the firmness of the coating and the substrate as well as the internal strength of the coating. BRIEF 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] Figure 5-9 , coating fastness test data DETAILED DESCRIPTION

[0034] In order to better illustrate the present invention, numerous specific details are provided in the following specific embodiments. It should be understood by those skilled in the art that the present invention can be implemented without certain specific details. In other examples, methods, means, equipment and steps well known to those skilled in the art are not described in detail in order to highlight the subject matter of the present invention.

[0035] Unless defined otherwise, 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 belongs.

[0036] In this specification, the numerical range expressed using "a numerical value A to a numerical value B" means a range including the endpoint numerical values ​​A and B.

[0037] In this specification, the word "may" means both performing a certain process and not performing a certain process.

[0038] It should be understood that the singular articles "a," "an," and "the," as used in this specification and the appended claims, include plural referents unless the context clearly dictates otherwise.

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

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

[0041] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the invention, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined. In the description of the present invention, the meaning of "several" is at least one, such as one, two, etc., unless otherwise clearly and specifically defined.

[0042] In the present invention, the solvent comprises one or more of water, low molecular weight alcohol (methanol, ethanol, isopropanol, butanol, amyl alcohol, ethylene glycol, propylene glycol, glycerol, etc.), N,N-dimethylformamide, N,N-dimethylacetamide, dimethyl sulfoxide, acetone, and phenol. Preferably, the solvent is a solvent or a mixed solvent that can dissolve 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 faster, the isopropanol in the solvent accounts for 15 to 70% of the total weight of the solvent, more preferably 20 to 60%, and further 30 to 50%. The mass fraction of the solvent in the coating composition ranges from 60% to 99.9%, preferably, the mass fraction ranges from 80 to 99%.

[0043] The coating composition of the present invention may also be added with auxiliary materials as required. The auxiliary materials include one or more of the following: leveling agent, defoaming agent, film-forming aid, viscosity regulator, pigment, antibacterial agent, colorant, surfactant, pH regulator, buffer, preservative, etc., to optimize and adjust the coating base liquid.

[0044] <First Embodiment>

[0045] Reference Figure 2 The present invention provides a central venous catheter with an antibacterial coating, comprising a catheter body 21, a tip 22, a connection seat 23, an extension tube 24 and an extension tube connector 25. The catheter body 21 is made of polyurethane material and is inserted into a human vein during a puncture operation to transport liquid to the human body. The tip 22 is located at one end of the catheter body 21, as the front end inserted into the human body, and is preferably a soft head to avoid damage to the blood vessels. The other end of the catheter body 21 is connected to the connection seat 23, and the connector 25 is connected to the connection seat 23 through the extension tube 24. The guide wire, liquid, etc. enter the catheter body 21 through the extension tube connector 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 flow of injection liquid. According to different usage conditions, the cavity can be one, two or more, for example, a single cavity, a double cavity, a triple cavity, a quadruple cavity, a quintuple cavity, etc.

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

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

[0049] Preferably, the connecting seat 23 is arc-shaped in the cross-section in the direction of the extension of the catheter length, especially the end close to the catheter body 21 is arc-shaped, and the contact surface with the human body is arc-shaped, which effectively ensures the safety and comfort when contacting the human body during use, and is not easy to cause indentation, damage and friction near the intervention port.

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

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

[0052] Reference Figure 1 and Figure 3 , respectively single-lumen central venous catheter and triple-lumen central venous catheter.

[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 an integer of 8-15, and m is selected from an integer of 2-6;

[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 containing a desired connecting group, preferably by a reaction on the biguanide group (such as general formula I) or by a reaction on the end group of the biguanide main chain (such as general formula II).

[0064] In certain preferred methods, the polymerizable Norrish I type photosensitive monomer is selected from at least one of benzil acrylate, aromatic 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 waterborne cationic polyurethane, waterborne anionic polyurethane and waterborne nonionic polyurethane.

[0065] Examples

[0066] With reference to the above implementation contents, 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 now exemplified. However, it should be noted that the following embodiments are listed to illustrate the present invention. Those skilled in the art can understand that the example is only an illustrative description and not an exhaustive description.

[0067] Embodiment 1:

[0068] Figure 2 A detailed view of the coating on the central venous catheter and 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 connector 25. The catheter body 21 is made of polyurethane material and is inserted into a human vein during a puncture operation to transport liquid to the human body. The tip 22 is located at one end of the catheter body 21, as the front end inserted into the human body, and is preferably a soft head to avoid damage to the blood vessel. The other end of the catheter body 21 is connected to the connection seat 23, and the connector 25 is connected to the connection seat 23 through the extension tube 24. The guide wire, liquid, etc. enter the catheter body 21 through the extension tube connector 25, the extension tube 24 and the connection seat 23. The catheter body 21 includes a cavity 26. The portion of the connection seat 23 close to the catheter body 21 in the cross section of the catheter length extension direction is arc-shaped.

[0069] Preparation Example 1:

[0070] <Synthesis of photocurable cationic guanidine copolymer 1>

[0071] 15g (6mmol) of polymerizable guanidine monomer of general formula (Ⅰ), 0.15g (0.3mmol) of aryl ketone acrylate (Norrish I type photosensitive monomer), 0.3g (0.5mmol) of benzophenone acrylate (Norrish II type photosensitive monomer) and 0.077g (0.5% by mass fraction of the total monomer amount) of azobisisobutyronitrile were added to a 100mL round-bottom flask, and 50mL of anhydrous ethanol was added and mechanically stirred to dissolve. The solution was deoxygenated by N2 for 30min, and the reaction bottle was placed in a 65°C oil bath for heating to start the reaction. After 6h of reaction, the reaction solution was removed and cooled to room temperature, precipitated in anhydrous ether, and the precipitate was dried in an oven at 35°C in the dark for 36h. The photocurable cationic guanidine copolymer was prepared and recorded as copolymer 1.

[0072] Preparation Example 2:

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

[0074] 15g (6mmol) of polymerizable guanidine monomer of general formula (II), 0.21g (0.3mmol) benzyl acrylate (Norrish I type photosensitive monomer), 0.38g (0.5mmol) thioxanthone acrylate (Norrish II type photosensitive monomer) and 0.077g (0.5% by mass of the total monomer amount) of azobisisobutyronitrile were added to a 100mL round-bottom flask, and 50mL of anhydrous ethanol was added and mechanically stirred to dissolve. The solution was deoxygenated by N2 for 30min, and the reaction bottle was placed in a 65°C oil bath for heating to start the reaction. After 6h of reaction, the reaction solution was removed and cooled to room temperature, precipitated in anhydrous ether, and the precipitate was dried in an oven at 35°C in the dark for 36h. The photocurable cationic guanidine copolymer was prepared and recorded as copolymer 2.

[0075] Preparation Example 3:

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

[0077] 15g (6mmol) of polymerizable guanidine monomer of general formula (Ⅰ), 0.4g (0.8mmol) of aromatic ketone acrylate (Norrish I type photosensitive monomer) and 0.077g (0.5% by mass fraction of the total monomer amount) of azobisisobutyronitrile were weighed and added to a 100mL round-bottom flask, and 50mL of anhydrous ethanol was added and mechanically stirred to dissolve. The solution was deoxygenated by passing N2 for 30min, and the reaction bottle was placed in a 65°C oil bath for heating to start the reaction. After 6h of reaction, the reaction solution was removed and cooled to room temperature, precipitated in anhydrous ether, and the precipitate was dried in an oven at 35°C in the dark for 36h. The photocurable cationic guanidine copolymer was prepared and recorded as copolymer 3.

[0078] Preparation Example 4:

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

[0080] 15g (6mmol) of polymerizable guanidine monomer of general formula (Ⅰ), 0.48g (0.8mmol) of benzophenone acrylate (Norrish II type photosensitive monomer) and 0.077g (0.5% by mass fraction of the total monomer amount) of azobisisobutyronitrile were added to a 100mL round-bottom flask, and 50mL of anhydrous ethanol was added and mechanically stirred to dissolve. The solution was deoxygenated by N2 for 30min, and the reaction bottle was placed in a 65°C oil bath for heating to start the reaction. After 6h of reaction, the reaction solution was removed and cooled to room temperature, precipitated in anhydrous ether, and the precipitate was dried in an oven at 35°C in the dark for 36h. The photocurable cationic guanidine copolymer was prepared and recorded as copolymer 3.

[0081] Embodiment 1:

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

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

[0084] Embodiment 2:

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

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

[0087] Comparative Example 1:

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

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

[0090] Comparative Example 2:

[0091] <Preparation and curing of antimicrobial coating composition 4>

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

[0093] Comparative Example 3:

[0094] <Preparation and curing of antimicrobial coating composition 4>

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

[0096] <Testing antibacterial properties>

[0097] Cut the ethylene oxide sterilized catheter into 0.5×0.5cm samples, put them into a sterile 48-well plate, with the coating facing up, add 10μL of bacterial solution with OD600=0.01, cover and place in a 37℃ constant temperature incubator for 3h. Add 500μL of liquid culture medium to soak the sample, shake it thoroughly and soak it for 10min, collect bacteria by ultrasound (150w) for 1 minute (10 seconds of ultrasound each time, stop for 5 seconds), and apply the plate after graded dilution at 1:100 and 1:500. After overnight incubation in a 37℃ constant temperature incubator, take pictures and count the number of colonies on the plate.

[0098] The catheter was tested for its antibacterial effect against Escherichia coli (E.coil) and Staphylococcus aureus (S.aureus). The number of colonies was counted using the plate coating method and compared with the uncoated catheter to 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 properties and can achieve very good antibacterial effects on both Gram-negative bacteria and Gram-positive bacteria. However, due to the lack of photoinitiator and hydrophilic polyurethane in Comparative Example 1 and Comparative Example 2, respectively, the antibacterial effect of the coating may be reduced due to reduced coating bonding.

[0101] <Testing firmness>

[0102] The firmness test was carried out on Implementation 1 and Example 2 as well as Comparative Examples 1-3. The firmness test method referred to TCSBME021-2020 "Evaluation Method for Lubrication Performance of Hydrophilic Coating of Catheter": The test was carried out using a friction tester in a water bath environment of (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 friction times were 5 times, and the test distance was 100 mm.

[0103] Test results such as Figure 5-9 shown.

[0104] From the experimental data, it can be seen that the antibacterial coating of the present invention has excellent coating firmness, and the friction coefficient remains close to the initial state without obvious increase after 5 friction cycles. However, due to the lack of Norrish I type / Norrish II type photoinitiator and hydrophilic polyurethane in Comparative Examples 1, 2 and 3, the coating firmness is reduced, which is specifically manifested in that the friction coefficient increases with 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, the antibacterial coating is formed by photocuring a coating composition, 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.

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 polymerizable guanidine monomer has a structure shown in 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.

5. The central venous catheter according to claim 4, characterized in that: 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.

6. 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.

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

8. 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.

9. 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.

10. 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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