Anti-infection and anti-coagulation central venous catheter coating and catheter preparation method

Abstract

The invention discloses an anti-infection and anti-coagulation central venous catheter coating and a catheter preparation method. The anti-infection and anti-coagulation central venous catheter coating is prepared from, by weight, 2.5%-3.0% of lubricating hydrophilic polymer, 0.3%-2.0% of anti-infection medicine, 0.5%-1.8% of coupling agent and 90%-95% of purified water. The anti-infection and anti-coagulation coating is coated on the central venous catheter in a high-temperature curing manner, so that the smoothness of the central venous catheter can be improved, the friction coefficient of the surface of the catheter is reduced, the adhesion of blood coagulation factors can be effectively prevented, the formation of thrombus can be prevented, and meanwhile, antibacterial drugs in the coating can be continuously released, so that the anti-infection and anti-coagulation effects are realized. Therefore, the catheter has an anti-infection function during the indwelling period.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an anti-infection and anti-coagulation central venous catheter coating and a catheter preparation method. Background Art

[0002] A central venous catheter is a commonly used vascular access catheter that is inserted through the internal jugular vein, subclavian vein, or femoral vein, with the tip located in the superior vena cava or inferior vena cava. It can be used for the infusion of drugs, fluids, and nutrition. Central venous catheters are in direct contact with blood during clinical use, so the material itself needs to have good blood compatibility. At the same time, during surgical operations and treatments, direct contact between the product and blood can also cause changes in the host's blood mechanism, which may lead to coagulation or thrombosis, causing surgical risks. In addition, the introduction of foreign devices may also lead to the risk of host infection. Although the use of central venous catheters provides convenience for blood purification treatment, it also increases the risk of infection or coagulation. Therefore, attention should be paid to the preparation of anti-infection and anti-coagulation for central venous catheters.

[0003] The most widely used central venous catheters are the Arrow series products developed and produced by Teleflex Corporation in the United States. The material of the catheter is polyurethane material, which mainly uses its own swelling characteristics to absorb antibacterial substances widely used in clinical practice, thereby achieving its anti-infection function, but this product does not have the function of anti-coagulation. The Vantex series of anti-coagulation and anti-infection central venous catheters produced by Edwards Corporation in the United States use OLIGON polymers (including silver, platinum, and black carbon) based on polyurethane, and the surface is also attached with an AMC thrombus protection layer, which is mainly composed of micro-batteries composed of silver, platinum, and carbon. Under spontaneous electrochemical reactions, silver ions with strong bactericidal properties are slowly released to achieve anti-infection effects, but the products currently using silver ions will gradually be eliminated. Hydromer Medical Coatings has invented a medical coating with super-lubricating properties, which can reduce the adhesion of blood cells and microorganisms on the surface of the tube, but this method cannot truly achieve the effect of anti-infection and anti-coagulation. Summary of the invention

[0004] The purpose of the present invention is to provide an anti-infection and anti-coagulation central venous catheter coating and a catheter preparation method to solve the problems of the existing anti-infection and anti-coagulation coating preparation method being cumbersome, poor anti-infection and anti-coagulation effects, and unstable coating.

[0005] To achieve the above object, the present invention provides the following technical solutions: The invention provides an anti-infection and anti-coagulation central venous catheter coating, which is composed of the following components in weight percentage: 2.5-3.0% of a lubricating hydrophilic polymer, 0.3-2.0% of an anti-infection drug, 0.5-1.8% of a coupling agent, and 90-95% of purified water.

[0006] Furthermore, the lubricating hydrophilic polymer is one or a mixture of medical-grade polyvinyl pyrrolidone, polyvinyl alcohol, carboxymethyl cellulose, and methyl cellulose.

[0007] Furthermore, the anti-infective drug is one or a mixture of several of tetracyclines, quinolones, macrolides, sulfonamides, chlorhexidine, triclosan, rifampicin, and quaternary ammonium salt compounds.

[0008] The antibacterial drugs used are common antibacterial drugs on the market. Due to individual differences, patients have idiosyncratic reactions to drugs and different tolerances to drugs. Medical staff can choose central venous catheters with appropriate drugs for treatment according to the patient's condition, which increases the applicability of the group. The proportion of the coating liquid can better couple the lubricating hydrophilic polymer with the anti-infective drug, and can also enhance the coating of the coating liquid and the central venous catheter.

[0009] Furthermore, the coupling agent is any one of silane coupling agent KH550, silane coupling agent KH560, and silane coupling agent KH792.

[0010] The present invention also provides a method for preparing an anti-infection and anti-coagulation central venous catheter, comprising the following steps: Step 1: Pretreatment of central venous catheter; Step 2: Preparation of anti-infection and anti-coagulation coating liquid; Step 3: Preparation of anti-infection and anti-coagulation central venous catheter.

[0011] Furthermore, the step 1 includes the following sub-steps: A1. Place the central venous catheter in an ultrasonic cleaning machine filled with purified water and clean it at a frequency of 30-50 Hz for 20-30 minutes. A2. Place the cleaned central venous catheter in a vacuum drying oven at 55-60°C for 30-45 minutes. A3. The dried central venous catheter should be stored in a normal temperature and pressure environment for future use.

[0012] Furthermore, the step 2 includes the following sub-steps: B1. Weigh the anti-infective drug, add purified water to dissolve it, and obtain an anti-infective drug solution; B2, adding the lubricating hydrophilic polymer to the anti-infective drug solution, and then shaking and mixing to dissolve; B3, adding a coupling agent to the mixed solution of the anti-infective drug and the lubricating hydrophilic polymer, and oscillating to mix; B4. Let the mixed solution stand at room temperature and pressure for later use. The coating solution is now ready.

[0013] Furthermore, the step three includes the following sub-steps: C1. Dip coating of central venous catheter: immerse the central venous catheter cleaned and dried in step 1 in the coating liquid for coating. The dipping time is 3-5 minutes. The dipping can also be performed twice or more. After dipping, collect the coating liquid. C2. Fixation of central venous catheter: slowly remove the dip-coated central venous catheter from the coating liquid, and then hang it on a specific bracket to prevent the dip-coating liquid from contacting other objects, which would cause uneven coating. Place the suspended central venous catheter in a vacuum drying oven, set the temperature to 80-100℃, and the curing time is 8-12 hours; C3. Place the solidified central venous catheter at room temperature and pressure for at least 12 hours. The preparation of the anti-infection and anti-coagulation central venous catheter is completed.

[0014] Based on the above technical solution, the embodiments of the present invention can at least produce the following technical effects: The present invention is to coat the anti-infection and anti-coagulation coating on the central venous catheter by high temperature curing, which can improve the smoothness of the central venous catheter and reduce the friction coefficient of the catheter surface, thereby effectively preventing the adhesion of coagulation factors and the formation of thrombus. At the same time, the antibacterial drugs in the coating can be continuously released to achieve the anti-infection function of the catheter during the indwelling period. The present invention has a simple manufacturing process, easy raw material acquisition, obvious effect, can reduce the occurrence of medical accidents, and provide protection for doctors and patients. DETAILED DESCRIPTION

[0015] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0016] It should be understood that the terms described in the present invention are only for describing special embodiments and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. Each smaller range between the intermediate value in any stated value or stated range and any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0017] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0018] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to the skilled artisan. The present invention description and examples are exemplary only.

[0019] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0020] The chemical reagents involved in the present invention are all commercially available.

[0021] Example 1

[0022] An anti-infection and anti-coagulation central venous catheter coating is prepared from the following raw materials according to mass fractions: 2.5% of a lubricating hydrophilic polymer, 1.0% of an anti-infection drug, 1.5% of a coupling agent, and 95% of the raw materials are purified.

[0023] The specific steps for preparing an anti-infection and anti-coagulation central venous catheter are as follows: Step 1: Pretreatment of central venous catheter A1. Remove the central venous catheter and place it in an ultrasonic cleaner filled with purified water at a frequency of 30 Hz for 30 minutes.

[0024] A2. Take out after cleaning, and then place it in a vacuum drying oven, set the temperature to 55℃, and dry it for 45 minutes.

[0025] A3. Take out after drying and store at normal temperature and pressure for future use.

[0026] Step 2: Preparation of anti-infection and anti-coagulation coating solution B1. Dissolution of anti-infective drugs: Weigh minocycline hydrochloride and then add purified water to dissolve it.

[0027] B2. Adding a lubricating hydrophilic polymer: Add polyvinyl pyrrolidone to the dissolved minocycline hydrochloride, and then shake and mix to dissolve.

[0028] B3. Addition of coupling agent: Add coupling agent KH560 to the mixed solution of minocycline hydrochloride and polyvinyl pyrrolidone, and shake to mix.

[0029] B4. The coating liquid is ready: the mixed solution is allowed to stand at room temperature and pressure for later use. The coating liquid is ready.

[0030] Step 3: Preparation of central venous catheter for infection and anticoagulation C1. Dip coating of central venous catheter: Take out the cleaned central venous catheter and immerse it in the coating liquid for coating. The dipping time is 3 minutes. It can also be dipped twice or more. After dipping, collect the coating liquid.

[0031] C2. Fixation of central venous catheter: Slowly remove the dip-coated central venous catheter from the coating liquid and hang it on a specific bracket to prevent the dip-coating liquid from contacting other objects, which would cause uneven coating. Place the suspended central venous catheter in a vacuum drying oven, set the temperature to 80°C, and cure for 12 hours.

[0032] C3. Finished product: Place the solidified central venous catheter at room temperature and pressure for at least 12 hours, and the preparation of the anti-infection and anti-coagulation central venous catheter is completed.

[0033] Example 2

[0034] An anti-infection and anti-coagulation central venous catheter coating is prepared from the following raw materials according to mass fractions: 3.0% of lubricating hydrophilic polymer, 2.0% of anti-infection drug, 1.5% of coupling agent, and 93.5% of purification.

[0035] Step 1: Pretreatment of central venous catheter A1. Remove the central venous catheter and place it in an ultrasonic cleaner filled with purified water at a frequency of 30 Hz for 20 minutes.

[0036] A2. Take out after cleaning, and then place it in a vacuum drying oven, set the temperature to 60℃, and dry it for 30 minutes.

[0037] A3. Take out after drying and store at normal temperature and pressure for future use.

[0038] Step 2: Preparation of anti-infection and anti-coagulation coating solution B1. Dissolution of anti-infective drugs: Weigh rifampicin and then add purified water to dissolve it.

[0039] B2. Adding lubricating hydrophilic polymer: Add polyvinyl alcohol to the dissolved rifampicin, and then shake to mix and dissolve.

[0040] B3. Addition of coupling agent: Add coupling agent KH550 to the mixed solution of polyvinyl alcohol and rifampicin, and shake to mix.

[0041] B4. The coating liquid is ready: the mixed solution is allowed to stand at room temperature and pressure for later use. The coating liquid is ready.

[0042] Step 3: Preparation of central venous catheter for infection and anticoagulation C1. Dip coating of central venous catheter: Take out the cleaned central venous catheter and immerse it in the coating liquid for coating. The dipping time is 5 minutes. The dipping can also be performed twice or more. After dipping, collect the coating liquid.

[0043] C2. Fixation of central venous catheter: Slowly remove the dip-coated central venous catheter from the coating liquid and hang it on a specific bracket to prevent the dip-coating liquid from contacting other objects, which would cause uneven coating. Place the suspended central venous catheter in a vacuum drying oven, set the temperature to 100°C, and cure for 8 hours.

[0044] C3. Finished product: Place the solidified central venous catheter at room temperature and pressure for at least 12 hours, and the preparation of the anti-infection and anti-coagulation central venous catheter is completed.

[0045] The above is only a preferred embodiment of the present invention. It should be pointed out that a person skilled in the art can make several modifications and improvements without departing from the inventive concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. An anti-infection and anti-coagulation central venous catheter coating, characterized in that: The invention is composed of the following components in weight percentage: 2.5-3.0% of lubricating hydrophilic polymer, 0.3-2.0% of anti-infective drug, 0.5-1.8% of coupling agent and 90-95% of purified water.

2. The anti-infection and anti-coagulation central venous catheter coating according to claim 1, characterized in that: The lubricating hydrophilic polymer is one or a mixture of medical-grade polyvinyl pyrrolidone, polyvinyl alcohol, carboxymethyl cellulose and methyl cellulose.

3. The anti-infection and anti-coagulation central venous catheter coating according to claim 1, characterized in that: The anti-infective drug is one or a mixture of tetracyclines, quinolones, macrolides, sulfonamides, chlorhexidine, triclosan, rifampicin, and quaternary ammonium salt compounds.

4. The anti-infection and anti-coagulation central venous catheter coating according to claim 1, characterized in that: The coupling agent used is any one of silane coupling agent KH550, silane coupling agent KH560, and silane coupling agent KH792.

5. A method for preparing an anti-infection and anti-coagulation central venous catheter, characterized in that: The following steps are involved: Step 1: Pretreatment of central venous catheter; Step 2: Preparation of anti-infection and anti-coagulation coating liquid; Step 3: Preparation of anti-infection and anti-coagulation central venous catheter.

6. The method for preparing the anti-infection and anti-coagulation central venous catheter according to claim 5, characterized in that: The step 1 includes the following sub-steps: A1. Place the central venous catheter in an ultrasonic cleaning machine filled with purified water and clean it at a frequency of 30-50 Hz for 20-30 minutes. A2. Place the cleaned central venous catheter in a vacuum drying oven at 55-60°C for 30-45 minutes. A3. The dried central venous catheter should be stored in a normal temperature and pressure environment for future use.

7. The method for preparing the anti-infection and anti-coagulation central venous catheter according to claim 5, characterized in that: The step 2 includes the following sub-steps: B1. Weigh the anti-infective drug, add purified water to dissolve it, and obtain an anti-infective drug solution; B2, adding the lubricating hydrophilic polymer to the anti-infective drug solution, and then shaking and mixing to dissolve; B3, adding a coupling agent to the mixed solution of the anti-infective drug and the lubricating hydrophilic polymer, and oscillating to mix; B4. Let the mixed solution stand at room temperature and pressure for later use. The coating solution is now ready.

8. The method for preparing the anti-infection and anti-coagulation central venous catheter according to claim 5, characterized in that: The step three includes the following sub-steps: C1. Dip coating of central venous catheter: immerse the central venous catheter cleaned and dried in step 1 in the coating liquid for coating, the dipping time is 3-5 min, and the coating liquid is collected after dipping; C2. Fixation of central venous catheter: slowly take out the dipped central venous catheter from the coating liquid, and then hang it on a specific bracket. Place the hung central venous catheter in a vacuum drying oven, set the temperature to 80-100℃, and cure it for 8-12 hours. C3. Place the solidified central venous catheter at room temperature and pressure for at least 12 hours. The preparation of the anti-infection and anti-coagulation central venous catheter is completed.