A medical catheter based on an amino sugar-silver ion complex antibacterial layer and a preparation method thereof

Abstract

The application discloses a kind of catheter head end and drainage hole area amino sugar-silver ion complex enhanced antibacterial medical catheter and preparation method thereof, belong to medical instrument surface functional modification technical field.The medical catheter includes catheter main body, catheter head and drainage hole, the outer surface of catheter head, drainage hole hole rim and drainage hole inner wall are equipped with amino sugar-silver ion complex enhanced antibacterial layer, amino sugar molecule is formed by amino and / or hydroxyl group and silver ion coordination complex structure.Preparation method includes substrate pretreatment, interface enhancement layer construction, hydrophilic lubricating layer construction, antibacterial solution preparation, local coating and solidification.The application realizes silver ion controllable slow-release by local enhancement antibacterial design, significantly reduces the risk of biofilm formation in drainage hole area, has good coating stability and biocompatibility, and is suitable for clinical drainage and interventional therapy field.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a medical catheter based on an amino sugar-silver ion complexed antibacterial layer and its preparation method. Background Technology

[0002] Medical catheters are widely used in clinical fluid delivery, body fluid drainage, urinary system assisted treatment, and interventional procedures. Common catheter materials include medical polyurethane, silicone rubber, and polyvinyl chloride, among other polymers.

[0003] Existing medical catheters still have the following problems in practical applications:

[0004] First, during catheter insertion or placement, the material surface comes into contact with human tissues, body fluids, or cavities, which can easily lead to protein adsorption, bacterial adhesion, and biofilm formation, increasing the risk of catheter-related infections.

[0005] Secondly, traditional antibacterial catheters often employ direct coating of silver ions, antibacterial polymers, or antibacterial drugs onto the catheter surface. While this method can improve early antibacterial performance, it still suffers from problems such as excessively rapid release of silver ions, insufficient late-stage antibacterial effect, increased risk of local cytotoxicity, and insufficient coating stability.

[0006] Furthermore, existing catheter antibacterial modifications often employ a uniform coating method across the entire surface, failing to adequately consider the varying infection risks at different locations on the catheter. The catheter tip, the edge of the drainage hole, and the inner wall of the drainage hole are high-risk areas for fluid flow, protein deposition, and bacterial adhesion; traditional uniform coatings are insufficient to provide effective protection for these critical areas.

[0007] Therefore, there is a need to develop a medical catheter surface modification technology that combines localized enhanced antibacterial properties, controlled release of silver ions, good biocompatibility, and coating stability. Summary of the Invention

[0008] (a) Technical problems to be solved

[0009] To address the shortcomings of existing technologies, this invention provides a medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer, solving the following main deficiencies of existing technologies: First, silver ions usually exist in a simple loading form, which is prone to initial burst release, leading to weakened antibacterial effect in the later stages and potentially increasing the risk of cytotoxicity; Second, existing antibacterial coatings are mostly uniform coatings without localized reinforcement design for high-risk infection areas such as the catheter tip, drainage hole edge, and inner wall of the hole; Third, the bonding stability between the antibacterial material and the catheter substrate is insufficient, and the coating may peel off during flushing, soaking, or long-term indwelling; Fourth, traditional antibacterial layers often only focus on antibacterial effect, lacking comprehensive design considerations for biocompatibility, blood compatibility, and long-term stability.

[0010] (II) Technical Solution

[0011] To achieve the above objectives, the present invention is implemented through the following technical solution: a medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer, and an aminoglycoside-silver ion complexed enhanced antibacterial medical catheter with catheter tip and drainage hole area, comprising a catheter body, a delivery cavity, a catheter head, a connecting part, and a drainage hole disposed on the side wall of the catheter head, wherein an aminoglycoside-silver ion complexed enhanced antibacterial layer is disposed on the outer surface of the catheter head, the edge of the drainage hole, and the inner wall of the drainage hole;

[0012] The amino sugar-silver ion complex-enhanced antibacterial layer comprises amino sugar complexing materials and silver ion materials;

[0013] The amino sugar complex material forms a coordination complex structure with silver ions through the amino and / or hydroxyl groups in its molecules. A hydrophilic lubricating layer is provided on the outer surface of the catheter body. The material of the hydrophilic lubricating layer is selected from one or more of polyethylene glycol, polyvinyl alcohol, or hyaluronic acid. An interface reinforcement layer is provided between the catheter body and the amino sugar-silver ion complex enhanced antibacterial layer. The interface reinforcement layer is a polydopamine interface layer. The polydopamine interface layer is provided on the outer surface of the catheter head, the edge of the drainage hole, and the inner wall surface of the drainage hole.

[0014] As a further preferred embodiment of the present invention, the drainage hole edge is provided with a continuous annular antibacterial coating, the width of which is 0.1 to 2.0 mm.

[0015] As a further preferred embodiment of the present invention, the thickness of the amino sugar-silver ion complex-enhanced antibacterial layer is 1-50 μm, preferably 5-20 μm.

[0016] As a further preferred embodiment of the present invention, the aminoglycoside complex material is selected from one or more of glucosamine, glucosamine hydrochloride, galactosamine, and galactosamine hydrochloride; the silver ion material is selected from one or more of silver nitrate, silver nanoparticles, or silver salts.

[0017] As a further preferred embodiment of the present invention, the material of the catheter body is selected from medical polyurethane, medical silicone rubber or medical polyvinyl chloride.

[0018] As a further preferred embodiment of the present invention, a method for preparing an aminoglycoside-silver ion complex-enhanced antibacterial medical catheter for the catheter tip and drainage port region includes the following steps:

[0019] Step S1: Pretreatment of conduit substrate – Cleaning, drying and surface activation treatment of the conduit substrate;

[0020] Step S2: Constructing the interface reinforcement layer—The pretreated catheter head, drainage hole edge and drainage hole inner wall area are brought into contact with the dopamine reaction system, so that dopamine is oxidized and self-polymerized on the catheter surface to form a polydopamine interface reinforcement layer.

[0021] Step S3: Constructing a hydrophilic lubricating layer—Constructing a hydrophilic lubricating layer on the outer surface of the catheter body;

[0022] Step S4: Preparation of amino sugar-silver ion complexed antibacterial solution - Dissolve amino sugar compounds in deionized water or buffer solution to prepare amino sugar solution, add silver ion solution to the amino sugar solution, stir the reaction to allow amino sugar molecules to coordinate and complex with silver ions, and obtain amino sugar-silver ion complexed antibacterial solution.

[0023] Step S5: Constructing a locally enhanced antibacterial layer—The amino sugar-silver ion complexed antibacterial solution obtained in step S4 is selectively coated on the outer surface of the catheter head, the edge of the drainage hole, and the inner wall of the drainage hole to form a locally enhanced antibacterial layer;

[0024] Step S6: Curing treatment – ​​The coated conduit is subjected to low-temperature drying or cross-linking curing treatment.

[0025] As a further preferred embodiment of the present invention, in step S4, the mass concentration of the amino sugar solution is 0.5% to 5.0%, preferably 1.0% to 3.0%; the silver ion solution is a silver nitrate solution with a concentration of 0.01 to 0.5 mol / L, preferably 0.05 to 0.2 mol / L; and the molar ratio of the amino sugar compound to silver ions is 1:0.1 to 1:2.

[0026] As a further preferred embodiment of the present invention, in step S4, the complexation reaction is carried out at room temperature and in the dark, the reaction time is 30 to 120 min, and the pH of the reaction system is 5.5 to 7.5.

[0027] As a further preferred embodiment of the present invention, in step S5, the coating method is selected from one of micro-drop coating, local dip coating, spray coating or microneedle injection.

[0028] As a further preferred embodiment of the present invention, in step S3, the hydrophilic lubricating layer is formed by dip coating, spray coating or spin coating, and its material is selected from one or more of polyethylene glycol, polyvinyl alcohol or hyaluronic acid.

[0029] (III) Beneficial Effects

[0030] This invention provides a medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer. It possesses the following beneficial effects:

[0031] Existing antibacterial catheters mostly use a uniform coating method across the entire surface, failing to fully consider the different infection risks at different locations on the catheter. This invention focuses on applying an aminoglycoside-silver ion complexed antibacterial layer to areas prone to bacterial adhesion, such as the catheter tip, the edge of the drainage hole, and the inner wall of the drainage hole, providing enhanced localized antibacterial protection for high-risk areas. Compared to ordinary catheters, this invention significantly reduces the risk of bacterial adhesion and biofilm formation at the catheter tip and drainage hole area.

[0032] Traditional silver ion antibacterial catheters typically employ direct silver ion loading, which often results in rapid early release but insufficient antibacterial effect in later stages. This invention utilizes an amino sugar-silver ion complex antibacterial system. By leveraging the amino and hydroxyl groups in the amino sugar molecule to form a complex with silver ions, the release behavior of silver ions is regulated, reducing the risk of burst release and improving antibacterial persistence. Compared to ordinary silver ion coatings, this invention is more conducive to achieving long-term stable antibacterial activity.

[0033] The drainage hole edge and inner wall are high-risk areas for fluid flow, protein deposition, and bacterial adhesion during catheter use. This invention forms a continuous annular antibacterial layer at the drainage hole edge and an antibacterial layer on the inner wall of the drainage hole, creating a localized antibacterial barrier around the drainage hole. This structure reduces microbial colonization in the hole edge area and lowers the risk of biofilm formation. Experimental results show that the biofilm coverage rate at the drainage hole edge of the locally enhanced antibacterial catheter of this invention can be reduced to 13.7%, significantly lower than the 78.6% of ordinary catheters and 42.3% of ordinary silver ion coated catheters.

[0034] This invention employs a zoned functional design. A hydrophilic lubricating layer is applied to the outer surface of the middle section of the catheter body, primarily to reduce frictional resistance during catheter insertion or use. An aminoglycoside-silver ion complexed antibacterial layer is applied to the catheter tip and drainage port area, mainly for localized enhanced antibacterial protection. Compared to catheters with a single antibacterial coating, this invention can simultaneously meet the dual requirements of catheter body lubrication and antibacterial protection in key areas.

[0035] This invention incorporates a polydopamine interface reinforcement layer between the catheter substrate and the amino sugar-silver ion complexed antibacterial layer, providing binding sites for the antibacterial layer and improving the bonding stability between the antibacterial layer and the catheter surface. This design reduces the risk of antibacterial layer detachment during flushing, immersion, or long-term use, thereby enhancing product reliability.

[0036] This invention utilizes aminoglycosides as silver ion complexing materials, which possess good biocompatibility. Compared to direct silver ion loading, the aminoglycoside-silver ion complex system can reduce the risk of local cytotoxicity while maintaining antibacterial activity, thus improving the biosafety of catheter materials.

[0037] The locally enhanced antibacterial catheter of this invention achieves an antibacterial rate of 96.8% after 24 hours and maintains an antibacterial rate of 89.5% after 7 days; while the antibacterial rate of ordinary silver ion coated catheters is 94.1% after 24 hours and decreases to 61.4% after 7 days. This indicates that the present invention not only has a good early antibacterial effect, but also has better sustained antibacterial ability.

[0038] Existing technologies mostly involve "coating the entire catheter surface with silver ions or antibacterial materials," a relatively conventional approach. This invention combines antibacterial materials, coating areas, and catheter structural characteristics to form a comprehensive structural solution: an "amino sugar-silver ion complexed antibacterial system + locally enhanced antibacterial layer at the catheter tip / drainage hole + annular antibacterial layer at the drainage hole edge + a main hydrophilic lubricating layer." Compared to existing technologies, this invention offers stronger structural specificity and clinical applicability. Attached Figure Description

[0039] Figure 1 : Schematic diagram of the overall structure of the medical catheter of the present invention.

[0040] Figure 2 : Schematic diagram of the multi-layer structure of the conduit cross-section of the present invention.

[0041] Figure 3 : A partially enlarged structural diagram of the catheter tip and drainage hole of the present invention.

[0042] Figure 4 : Schematic diagram of the amino sugar-silver ion complexed antibacterial layer of the present invention.

[0043] In the diagram: 1-Catheter body; 2-Hydrophilic lubricating layer; 3-Amino sugar-silver ion composite antibacterial functional layer; 4-Delivery cavity; 5-Connecting part; 6-Catheter head; 7-Drainage hole. Detailed Implementation

[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] Please see Figure 1-4This invention provides a technical solution: The structure of the medical catheter of this invention includes: a catheter body (a medical catheter 1 based on an aminoglycoside-silver ion complex antibacterial layer, made of medical polyurethane, medical silicone rubber, or medical polyvinyl chloride, etc., with a through-hole delivery cavity inside); and a hydrophilic lubrication layer (a medical catheter 2 based on an aminoglycoside-silver ion complex antibacterial layer, disposed on the outer surface of the catheter body and the medical catheter 1 based on an aminoglycoside-silver ion complex antibacterial layer, which can be formed of hydrophilic materials such as polyethylene glycol, polyvinyl alcohol, and hyaluronic acid, to improve the lubrication performance of the catheter surface). An interface enhancement layer, preferably a polydopamine interface layer, is disposed on the catheter tip, drainage hole, drainage hole edge, and drainage hole of a medical catheter based on an aminoglycoside-silver ion complex antibacterial layer. This layer provides binding sites for the aminoglycoside-silver ion complex antibacterial layer. An aminoglycoside-silver ion complex enhanced antibacterial layer is disposed on the outer surface of the catheter tip, drainage hole edge, and drainage hole of a medical catheter based on an aminoglycoside-silver ion complex antibacterial layer, forming a locally enhanced antibacterial area. A medical catheter 7 with an aminoglycoside-silver ion complex antibacterial layer has a drainage hole. The drainage hole of the medical catheter 7 has an annular antibacterial structure at its edge. A continuous annular antibacterial coating is formed at the edge of the drainage hole, creating an antibacterial barrier around the drainage hole, reducing bacterial adhesion and biofilm formation at the hole edge.

[0046] Preparation method

[0047] The present invention also provides a method for preparing the above-mentioned medical catheter, comprising the following steps:

[0048] Step S1: Pretreatment of catheter substrate

[0049] Choose medical polyurethane, medical silicone rubber, or medical polyvinyl chloride catheters as the base material.

[0050] The conduit is cleaned, dried, and surface activated to remove surface impurities and improve the adhesion of subsequent coatings.

[0051] Step S2: Construct the UI enhancement layer

[0052] The pretreated catheter tip, drainage hole, and inner wall area of ​​a medical catheter based on an aminoglycoside-silver ion complex antibacterial layer are brought into contact with a dopamine reaction system, causing dopamine to oxidize and polymerize on the catheter surface, forming a polydopamine interface reinforcement layer.

[0053] This layer is used to improve the bonding stability between the amino sugar-silver ion complexed antibacterial layer and the catheter substrate.

[0054] Step S3: Constructing a hydrophilic lubricating layer. A medical catheter based on an amino sugar-silver ion complexed antibacterial layer.

[0055] A hydrophilic lubricating layer is constructed on the outer surface of the outer surface of a medical catheter based on an aminoglycoside-silver ion complex antibacterial layer 1. A medical catheter based on an aminoglycoside-silver ion complex antibacterial layer 2. A medical catheter based on an aminoglycoside-silver ion complex antibacterial layer.

[0056] A medical catheter with a hydrophilic lubricating layer based on an amino sugar-silver ion complex antibacterial layer 2 A medical catheter based on an amino sugar-silver ion complex antibacterial layer can be formed by dip coating, spray coating or spin coating, and the material can be selected from polyethylene glycol, polyvinyl alcohol or hyaluronic acid.

[0057] This layer is mainly used to reduce frictional resistance during catheter use.

[0058] Step S4: Preparation of amino sugar-silver ion complexed antibacterial solution

[0059] An aminoglycoside solution is prepared by dissolving an aminoglycoside compound in deionized water or a buffer solution. The aminoglycoside compound is preferably glucosamine hydrochloride, but one or more of glucosamine, galactosamine, and galactosamine hydrochloride may also be used.

[0060] Preferably, the mass concentration of the amino sugar solution is 0.5% to 5.0%, more preferably 1.0% to 3.0%. During the preparation process, the mixture can be stirred at room temperature for 10 to 30 minutes to fully dissolve the amino sugar compounds and obtain a clear or uniformly dispersed amino sugar solution.

[0061] Subsequently, a silver ion solution is slowly added to the above-mentioned amino sugar solution. The silver ion solution is preferably a silver nitrate solution with a concentration of 0.01–0.5 mol / L, more preferably 0.05–0.2 mol / L. The addition should be done dropwise under stirring to avoid excessively high local silver ion concentrations, which could lead to precipitation or uneven complexation.

[0062] The molar ratio of amino sugar to silver ions can be controlled to be 1:0.1 to 1:2, preferably 1:0.5 to 1:1. By adjusting the ratio of amino sugar to silver ions, the degree of complexation of silver ions in the antibacterial solution and their subsequent release behavior can be controlled.

[0063] After the silver ions are added, continue stirring for 30–120 min to allow the amino and hydroxyl groups in the amino sugar molecules to fully coordinate and complex with the silver ions, forming an amino sugar-silver ion complex antibacterial system. The complexation reaction is preferably carried out at room temperature and in the dark to reduce the risk of silver ions being reduced or precipitated by light.

[0064] In a preferred embodiment, the pH of the reaction system can be adjusted to 5.5–7.5 to ensure that the amino sugar molecules have good solubility and complexing ability, while reducing the formation of silver salt precipitates. Dilute hydrochloric acid, sodium hydroxide solution, or physiologically compatible buffer solution can be used as the pH adjuster.

[0065] After the reaction is complete, filtration with a 0.22μm or 0.45μm filter membrane can be used to remove undissolved particles or impurities, resulting in a stable and homogeneous aminoglycoside-silver ion complexed antibacterial solution. The obtained antibacterial solution can be directly applied to the catheter tip, drainage port, and inner wall area of ​​a medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer.

[0066] In one specific embodiment, glucosamine hydrochloride is weighed and dissolved in deionized water to prepare a 2.0% (w / w) glucosamine hydrochloride solution. Under light-protected stirring conditions, 0.1 mol / L silver nitrate solution is slowly added dropwise to achieve a molar ratio of glucosamine hydrochloride to silver ions of 1:0.5. Stirring continues for 60 min to form a glucosamine-silver ion complex antibacterial solution. The resulting antibacterial solution is used for the subsequent local enhancement of the antibacterial coating in the catheter tip and drainage port of a medical catheter based on an glucosamine-silver ion complex antibacterial layer.

[0067] In the aminoglycoside-silver ion complexed antibacterial solution prepared by the above method, aminoglycoside molecules can form coordination complexes with silver ions through amino and hydroxyl groups. Compared with direct silver ion loading, this complexation system is beneficial for reducing the initial burst release of silver ions, improving the stability of silver ion release, and enhancing the sustained antibacterial ability and biocompatibility of the catheter antibacterial layer.

[0068] Step S5: Construct a locally enhanced antibacterial layer

[0069] A medical catheter based on an aminoglycoside-silver ion complex antibacterial solution is selectively coated onto the outer surface of the catheter tip, the drainage hole, and the inner wall of the catheter. This includes a medical catheter with an aminoglycoside-silver ion complex antibacterial layer, a catheter with an aminoglycoside-silver ion complex antibacterial layer, and a catheter with an aminoglycoside-silver ion complex antibacterial layer.

[0070] The coating method can be micro-drop coating, local dip coating, spray coating or microneedle injection.

[0071] Through this step, a locally enhanced antibacterial layer is formed at the catheter tip and drainage port of a medical catheter 7 based on an aminoglycoside-silver ion complex antibacterial layer. The thickness of the aminoglycoside-silver ion complex antibacterial layer is 1–50 μm, preferably 5–20 μm; the width of the continuous annular antibacterial layer at the edge of the drainage port of the medical catheter 7 based on an aminoglycoside-silver ion complex antibacterial layer is 0.1–2.0 mm, preferably 0.3–1.0 mm.

[0072] Step S6: Curing treatment

[0073] The coated catheter is subjected to low-temperature drying or cross-linking curing treatment to stabilize the amino sugar-silver ion complexed antibacterial layer on the catheter surface.

[0074] The final product was a medical catheter based on an amino sugar-silver ion complexed antibacterial layer.

[0075] Example 1: Glucosamine hydrochloride-silver ion complexed antibacterial layer catheter

[0076] Medical polyurethane catheters were selected as the substrate and surface activated after being cleaned with ethanol, rinsed with deionized water and dried.

[0077] The catheter tip and drainage hole area are placed in dopamine buffer solution to form a polydopamine interface enhancement layer on its surface.

[0078] Prepare an glucosamine hydrochloride solution and add silver nitrate solution to form an glucosamine-silver ion complex antibacterial solution.

[0079] The antibacterial solution was locally applied to the catheter tip, the edge of the drainage hole, and the inner wall of the drainage hole. After low-temperature drying and curing, a medical catheter with enhanced antibacterial properties was obtained in the catheter tip and drainage hole area.

[0080] Example 2: Aminogalactosyl hydrochloride-silver ion complexed antibacterial layer conduit

[0081] This embodiment is basically the same as Embodiment 1, except that glucosamine hydrochloride is replaced with D-(+)-galactosamine hydrochloride.

[0082] This embodiment is used to illustrate that the amino sugar complexing material described in this invention is not limited to glucosamine hydrochloride, and other amino sugar salts may also be used.

[0083] Example 3: Synergistic catheter with hydrophilic lubricating layer and localized antibacterial enhancement layer

[0084] Based on Example 1, a PEG hydrophilic lubricating layer is further constructed on the outer surface of the middle section of the catheter body, while an glucosamine-silver ion complexed antibacterial layer is constructed at the catheter tip and drainage hole area.

[0085] This results in a zoned functionalized catheter with lubrication of the main body and enhanced antibacterial function in the tip / drainage area.

[0086] Comparative Example 1: Unmodified Medical Catheters

[0087] Ordinary medical polyurethane catheters are used, without hydrophilic lubrication or antibacterial layer treatment.

[0088] Comparative Example 2: Ordinary silver ion coated catheter

[0089] The silver ion solution is directly coated onto the surface of the catheter, without using amino sugar complexing materials.

[0090] This comparative example was used to evaluate the effect of the amino sugar-silver ion complex system on the stability of silver ion release and the duration of antibacterial activity.

[0091] Comparative Example 3: Valves with uniform antibacterial coating on the entire surface

[0092] The amino sugar-silver ion complexed antibacterial layer is uniformly coated on the entire outer surface of the catheter, without any local reinforcement design at the catheter tip and drainage hole area.

[0093] This comparative example is used to evaluate the contribution of locally enhanced antibacterial structures to the antibacterial effect in the drainage hole area.

[0094] Comparative Example 4: Conduit without Interface Reinforcement Layer

[0095] Without setting a polydopamine interface enhancement layer, the amino sugar-silver ion complex antibacterial solution is directly coated on the catheter tip and drainage hole area.

[0096] This comparative example is used to evaluate the effect of the interface enhancement layer on the binding stability of the antibacterial layer.

[0097] Antibacterial performance evaluation

[0098] Staphylococcus aureus and Escherichia coli were used as test bacteria to compare the antibacterial rates of different samples.

[0099] Key comparisons: (1) ordinary catheter; (2) ordinary silver ion coated catheter; (3) catheter with uniform antibacterial coating on the entire surface; (4) the locally enhanced antibacterial catheter of the present invention.

[0100] Evaluation of biofilm inhibition in the drainage hole area focuses on observing bacterial adhesion and biofilm formation at the edge and inner wall of the drainage hole.

[0101] The silver ion release performance was evaluated by detecting the amount of silver ions released at different time points and assessing the regulatory effect of the amino sugar-silver ion complex structure on the silver ion release behavior.

[0102] To evaluate the stability of the coating, the sample was immersed and rinsed in simulated body fluid to observe whether the antibacterial layer peeled off.

[0103] Biocompatibility evaluation, in accordance with the requirements for biocompatibility evaluation of medical devices, includes evaluation of cytotoxicity, hemolytic properties, and sensitization.

[0104] Experimental results

[0105] Standard catheter 8.5% 5.2% 78.6% Ordinary silver ion coated catheter 94.1% 61.4% 42.3% Uniform amino sugar-silver coated conduit across the entire surface 95.3% 75.6% 31.8% The present invention provides a locally enhanced antibacterial catheter 96.8% 89.5% 13.7%

[0106] Each group of samples was tested in triplicate, and the average value was taken. These results demonstrate that the locally enhanced antibacterial catheter of this invention not only exhibits good early antibacterial performance but also maintains a high antibacterial rate after 7 days and can significantly reduce the biofilm coverage at the drainage hole edge.

[0107] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or basic characteristics. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of the same elements of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0108] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer, comprising a catheter body (1), a delivery cavity (4), a catheter head (6), a connecting portion (5), and a drainage hole (7) disposed on the side wall of the catheter head (6), characterized in that: The outer surface of the catheter head (6), the edge of the drainage hole (7) and the inner wall of the drainage hole (7) are provided with an amino sugar-silver ion complex-enhanced antibacterial layer (3). The amino sugar-silver ion complex-enhanced antibacterial layer (3) comprises amino sugar complex materials and silver ion materials; The amino sugar complex material forms a coordination complex structure with silver ions through the amino and / or hydroxyl groups in its molecule. A hydrophilic lubricating layer (2) is provided on the outer surface of the catheter body (1). The material of the hydrophilic lubricating layer (2) is selected from one or more of polyethylene glycol, polyvinyl alcohol or hyaluronic acid. An interface enhancement layer is provided between the catheter body (1) and the amino sugar-silver ion complex enhanced antibacterial layer (3). The interface enhancement layer is a polydopamine interface layer. The polydopamine interface layer is provided on the outer surface of the catheter head (6), the edge of the drainage hole (7) and the inner wall surface of the drainage hole (7).

2. The medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer according to claim 1, characterized in that: The drainage hole (7) is provided with a continuous annular antibacterial coating at its edge, and the width of the continuous annular antibacterial coating is 0.1 to 2.0 mm.

3. The medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer according to claim 1, characterized in that: The thickness of the amino sugar-silver ion complex-enhanced antibacterial layer (3) is 1-50 μm, preferably 5-20 μm.

4. A medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer according to claim 1, characterized in that: The aminoglycoside complex material is selected from one or more of glucosamine, glucosamine hydrochloride, galactosamine, and galactosamine hydrochloride; the silver ion material is selected from one or more of silver nitrate, silver nanoparticles, or silver salts.

5. A medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer according to claim 1, characterized in that: The material of the catheter body (1) is selected from medical polyurethane, medical silicone rubber or medical polyvinyl chloride.

6. A method for preparing an aminoglycoside-silver ion complex-enhanced antibacterial medical catheter as described in any one of claims 1 to 5, characterized in that, Includes the following steps: Step S1: Pretreatment of conduit substrate – Cleaning, drying and surface activation treatment of the conduit substrate; Step S2: Constructing an interface reinforcement layer—The pretreated catheter head (6), the edge of the drainage hole (7) and the inner wall area of ​​the drainage hole (7) are brought into contact with the dopamine reaction system, so that dopamine is oxidized and self-polymerized on the surface of the catheter to form a polydopamine interface reinforcement layer. Step S3: Constructing a hydrophilic lubricating layer—Constructing a hydrophilic lubricating layer (2) on the outer surface of the catheter body (1); Step S4: Preparation of amino sugar-silver ion complexed antibacterial solution - Dissolve amino sugar compounds in deionized water or buffer solution to prepare amino sugar solution, add silver ion solution to the amino sugar solution, stir the reaction to allow amino sugar molecules to coordinate and complex with silver ions, and obtain amino sugar-silver ion complexed antibacterial solution. Step S5: Constructing a locally enhanced antibacterial layer—The amino sugar-silver ion complexed antibacterial solution obtained in step S4 is selectively coated on the outer surface of the catheter head (6), the edge of the drainage hole (7), and the inner wall of the drainage hole (7) to form a locally enhanced antibacterial layer; Step S6: Curing treatment – ​​The coated conduit is subjected to low-temperature drying or cross-linking curing treatment.

7. The method for preparing a medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer according to claim 6, characterized in that: In step S4, the mass concentration of the amino sugar solution is 0.5% to 5.0%, preferably 1.0% to 3.0%; the silver ion solution is a silver nitrate solution with a concentration of 0.01 to 0.5 mol / L, preferably 0.05 to 0.2 mol / L; and the molar ratio of the amino sugar compound to silver ions is 1:0.1 to 1:

2.

8. The method for preparing a medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer according to claim 6, characterized in that: In step S4, the complexation reaction is carried out at room temperature and in the dark for a reaction time of 30 to 120 minutes, and the pH of the reaction system is 5.5 to 7.

5.

9. The method for preparing a medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer according to claim 6, characterized in that: In step S5, the coating method is selected from one of micro-drop coating, local dip coating, spray coating, or microneedle injection.

10. The method for preparing a medical catheter based on an aminoglycoside-silver ion complexed antibacterial layer according to claim 6, characterized in that: In step S3, the hydrophilic lubricating layer (2) is formed by dip coating, spray coating or spin coating, and its material is selected from one or more of polyethylene glycol, polyvinyl alcohol or hyaluronic acid.

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