Medical catheter as well as preparation method and application thereof

Abstract

The invention provides a medical catheter and a preparation method and application thereof, and relates to the technical field of medical instruments. The medical catheter comprises a base material catheter and an anti-infection layer loaded on the surface of the base material catheter. Wherein the base material conduit contains 0.001 to 0.1 weight percent of nano zinc oxide; the anti-infection layer is mainly composed of an NO donor and silicone oil. The NO donor is loaded on the surface layer of the medical catheter to form the anti-infection layer, and the catheter can continuously release NO in the blood contact process so as to achieve the anti-coagulation and anti-infection effects; meanwhile, a silicone oil component is further arranged in the anti-infection layer, the silicone oil component and the base material catheter containing 0.001-0.1 wt% of nano-zinc oxide cooperate with each other, the release amount of NO in the process that the medical catheter makes contact with blood is increased, and meanwhile the long-acting and stable release effect of NO is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a medical catheter and a preparation method and application thereof. Background Art

[0002] At present, blood-contact medical devices are increasingly used in clinical practice, saving countless patients, and the clinical problems related to them are also receiving more and more attention from researchers. The clinical problems caused by blood-contact medical devices mainly include coagulation and infection. It is worth noting that the two complications of coagulation and infection are interrelated. The occurrence of coagulation will promote the occurrence of infection, and vice versa. At present, anticoagulants and antibiotics are mostly used clinically to deal with these two clinical problems. However, improper dosage of anticoagulants can easily induce bleeding risks, and antibiotics can induce the production of drug-resistant bacteria. In addition, for device-related infections, especially the formation of biofilms, traditional antibiotics can play a very limited role.

[0003] Therefore, it is necessary and urgent to research and develop a blood-contacting medical catheter that has good anticoagulant and anti-infection effects when in contact with blood.

[0004] In view of this, the present invention is proposed. Summary of the invention

[0005] The first object of the present invention is to provide a medical catheter, which can release NO in a long-term and stable manner during contact with blood, and has good anticoagulant and anti-infection effects as a blood-contact medical catheter.

[0006] A second object of the present invention is to provide a method for preparing a medical catheter.

[0007] The third object of the present invention is to provide an application of a medical catheter, which can be widely used in the preparation process of blood-contact medical anticoagulant and anti-infection catheters.

[0008] In order to achieve the above-mentioned purpose of the present invention, the following technical solutions are particularly adopted:

[0009] The present invention provides a medical catheter, which comprises a substrate catheter and an anti-infection layer loaded on the surface of the substrate catheter;

[0010] The substrate conduit contains 0.001-0.1wt% of nano zinc oxide;

[0011] The anti-infection layer is mainly composed of NO donor and silicone oil.

[0012] Furthermore, the substrate conduit is mainly made of polyurethane or silicone rubber;

[0013] Preferably, the substrate catheter is a polyurethane catheter containing 0.03% nano zinc oxide;

[0014] Furthermore, the particle size of the nano zinc oxide is 40 to 55 nm.

[0015] Furthermore, the NO donor is at least one of S-nitroso-N-acetylpenicillamine, S-nitrosocysteine, and S-nitrosoglutathione.

[0016] The present invention provides a method for preparing a medical catheter, the method comprising:

[0017] (A) providing a solution containing an NO donor and a substrate conduit, wherein the substrate conduit contains 0.001 to 0.1% nano zinc oxide;

[0018] (B) immersing the substrate conduit in a solution containing an NO donor so that the NO donor is impregnated on the surface of the substrate conduit, followed by sequentially purging, cleaning, and drying to obtain an intermediate conduit A;

[0019] (C) The intermediate catheter A is immersed in silicone oil, and then purged, cleaned, and dried in sequence to obtain a medical catheter.

[0020] Further, the solution containing the NO donor is a tetrahydrofuran solution containing S-nitroso-N-acetylpenicillamine;

[0021] Preferably, the content of S-nitroso-N-acetylpenicillamine in the solution containing the NO donor is 0.1-30%.

[0022] Furthermore, in step (B), the substrate catheter is immersed in the solution containing the NO donor for 30 to 90 minutes at a temperature of 20 to 30°C.

[0023] Furthermore, the silicone oil in step (C) is silicone oil with a concentration of 70 to 85%;

[0024] Preferably, the intermediate conduit A is immersed in silicone oil for 8 to 12 hours at a temperature of 20 to 30°C.

[0025] Furthermore, the step (B) is performed by immersing in a closed tank;

[0026] Preferably, the preparation method further comprises: before the soaking in step (B) begins, introducing nitrogen into the closed tank.

[0027] The present invention provides an application of the above-mentioned medical catheter in the preparation of blood-contact medical anticoagulant and anti-infection catheters.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] The medical catheter provided by the present invention comprises a substrate catheter and an anti-infection layer loaded on the surface of the substrate catheter; wherein the substrate catheter contains 0.001-0.1wt% of nano zinc oxide; and the anti-infection layer is mainly composed of an NO donor and silicone oil. In the present application, the NO donor is loaded on the surface of the medical catheter to form an anti-infection layer, and the catheter will continuously release NO during contact with blood, thereby playing an anticoagulant and anti-infection role; at the same time, the present application uses a substrate catheter containing 0.001-0.1wt% of nano zinc oxide and cooperates with the silicone oil component set in the anti-infection layer, which not only increases the amount of NO released during contact between the medical catheter of the present application and blood, but also realizes the long-term and stable release of NO. Therefore, the medical catheter of the present application has better anti-infection and anti-coagulant effects as a blood-contact catheter.

[0030] The preparation method of the medical catheter provided by the present invention first immerses a substrate catheter containing 0.001-0.1% nano zinc oxide in a solution containing an NO donor, so that the NO donor is impregnated on the surface of the substrate catheter, and then purges, cleans, and dries in sequence to obtain an intermediate catheter A; then immerses the intermediate catheter A in silicone oil, and purges, cleans, and dries in sequence to obtain a medical catheter. The preparation method of the medical catheter of the present application has the advantages of simple processing technology and easy operation.

[0031] The medical catheter provided by the present invention can be widely used in the preparation process of blood-contact medical anticoagulant and anti-infection catheters. DETAILED DESCRIPTION

[0032] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] According to one aspect of the present invention, a medical catheter comprises a substrate catheter and an anti-infection layer loaded on the surface of the substrate catheter;

[0034] The substrate conduit contains 0.001-0.1wt% of nano zinc oxide;

[0035] The anti-infection layer is mainly composed of NO donor and silicone oil.

[0036] The medical catheter provided by the present invention comprises a substrate catheter and an anti-infection layer loaded on the surface of the substrate catheter; wherein the substrate catheter contains 0.001-0.1wt% of nano zinc oxide; and the anti-infection layer is mainly composed of an NO donor and silicone oil. The applicant has found that NO is one of the most important signal molecules in the body, and it has a good application prospect in anti-infection and anti-coagulation. In the present application, the NO donor is loaded on the surface of the medical catheter to form an anti-infection layer. During the contact with blood, the medical catheter will continuously release NO, thereby playing an anti-coagulation and anti-infection role.

[0037] At the same time, the applicant has found through research that the anti-infection layer formed by loading the NO donor on the surface of the substrate catheter alone has a low release of NO during contact with blood and cannot achieve long-term and stable release.

[0038] In order to overcome the above problems, the present application uses a nano zinc oxide containing 0.001-0.1wt% as a base material catheter. Under the body temperature of the human body, the nano zinc oxide in the medical catheter can accelerate the release of NO donors; in addition, the anti-infection layer of the medical catheter of the present application also contains a layer of silicone oil component, which can play the role of long-term release of NO. Therefore, the present application uses a nano zinc oxide base material catheter containing 0.001-0.1wt% and sets a silicone oil component in the anti-infection layer. The two technical features cooperate with each other, not only increasing the amount of NO released during the contact between the medical catheter of the present application and blood, but also achieving the effect of long-term and stable release of NO. The medical catheter of the present application has better anti-infection and anticoagulant effects as a blood contact catheter.

[0039] It should be noted that the main function of the nano zinc oxide in the substrate catheter of the present application is to promote the rate of NO release from the NO donor. In the temperature and humidity environment after the catheter is implanted in the human body, the nano zinc oxide can promote the NO donor (such as S-nitroso-N-acetylpenicillamine) to release NO.

[0040] At the same time, it should be noted that the content of nano zinc oxide in the substrate catheter of the present application (0.001-0.1wt%) is obtained by the applicant through long-term research. If the content of nano zinc oxide is too low, the rate of NO release from the catheter will be very slow under the protection of the silicone oil layer, and it will be difficult to achieve the anti-infection and anticoagulant effects. However, if the content of nano zinc oxide in the catheter is too high (>0.1wt%), it will affect the difficulty of preparing and molding the catheter.

[0041] In a preferred embodiment of the present invention, the substrate conduit is mainly made of polyurethane or silicone rubber;

[0042] In a preferred embodiment of the present invention, the substrate catheter is a polyurethane catheter containing 0.03% nano zinc oxide;

[0043] It should be noted that the specifications of the catheter of the present application can be adjusted according to the application environment. Taking the ECMO cannula as an example: the inner diameter of the catheter is 2-9mm, and the outer diameter of the catheter is 3-10mm.

[0044] In a preferred embodiment of the present invention, the particle size of the nano zinc oxide is 40-55 nm.

[0045] In a preferred embodiment of the present invention, the NO donor is at least one of S-nitroso-N-acetylpenicillamine, S-nitrosocysteine, and S-nitrosoglutathione.

[0046] The preparation method of the substrate conduit of the present application can be prepared by a conventional conduit preparation method. Exemplarily, the preparation method of the substrate conduit includes: fully mixing an appropriate amount of nano zinc oxide and polyurethane masterbatch, then extruding through an extruder to form a tube, cooling, and cutting to obtain the substrate conduit.

[0047] According to one aspect of the present invention, a method for preparing a medical catheter comprises:

[0048] (A) providing a solution containing an NO donor and a substrate conduit, wherein the substrate conduit contains 0.001 to 0.1% nano zinc oxide;

[0049] (B) immersing the substrate conduit in a solution containing an NO donor so that the NO donor is impregnated on the surface of the substrate conduit, followed by sequentially purging, cleaning, and drying to obtain an intermediate conduit A;

[0050] (C) The intermediate catheter A is immersed in silicone oil, and then purged, cleaned, and dried in sequence to obtain a medical catheter.

[0051] The preparation method of the medical catheter provided by the present invention first immerses a substrate catheter containing 0.001-0.1% nano zinc oxide in a solution containing an NO donor, so that the NO donor is impregnated on the surface of the substrate catheter, and then purges, cleans, and dries in sequence to obtain an intermediate catheter A; then immerses the intermediate catheter A in silicone oil, and purges, cleans, and dries in sequence to obtain a medical catheter. The preparation method of the medical catheter of the present application has the advantages of simple processing technology and easy operation.

[0052] In a preferred embodiment of the present invention, the solution containing the NO donor is a tetrahydrofuran solution containing S-nitroso-N-acetylpenicillamine;

[0053] In the above preferred embodiment, the content of S-nitroso-N-acetylpenicillamine in the solution containing NO donor is 0.1-30%.

[0054] As a preferred embodiment, the content of S-nitroso-N-acetylpenicillamine in the above-mentioned solution containing NO donor is 0.1-30%. It has been verified that if the content of S-nitroso-N-acetylpenicillamine in the solution containing NO donor in the present application is higher than 30%, not only S-nitroso-N-acetylpenicillamine is difficult to dissolve, but also the catheter will produce cytotoxicity.

[0055] In a preferred embodiment of the present invention, in step (B), the substrate catheter is immersed in the solution containing the NO donor for 30 to 90 minutes at a temperature of 20 to 30°C.

[0056] As a preferred embodiment, the substrate catheter is immersed in the solution containing the NO donor for 30 to 90 minutes. The present application has found through research that when the substrate catheter is immersed in the solution containing the NO donor for less than 30 minutes, it will be difficult for S-nitroso-N-acetylpenicillamine to form a coating on the catheter surface, and the content of S-nitroso-N-acetylpenicillamine on the catheter surface is too low, thereby affecting the antibacterial and anticoagulant effects during the subsequent use of the catheter. If the immersion time is too long, the processing time will increase and the production efficiency will be low.

[0057] It should also be noted that the immersion temperature of the present application is 20 to 30°C. Since the solvent tetrahydrofuran has a low boiling point and is volatile at room temperature, if the immersion temperature is too high, the solvent will evaporate quickly, resulting in inaccurate concentration; if the temperature is too low, the solubility will decrease and S-nitroso-N-acetylpenicillamine will precipitate. Therefore, if the immersion temperature is too low or too high, the content of S-nitroso-N-acetylpenicillamine on the surface of the catheter will be affected. If the temperature is too high, S-nitroso-N-acetylpenicillamine will decompose due to heat, thereby losing the effect of releasing NO.

[0058] In a preferred embodiment of the present invention, the silicone oil in step (C) is silicone oil with a concentration of 70 to 85%;

[0059] In a preferred embodiment of the present invention, the intermediate conduit A is immersed in silicone oil for 8 to 12 hours at a temperature of 20 to 30°C.

[0060] As a preferred embodiment, if the intermediate conduit A is immersed in the silicone oil for less than 8 hours, it is difficult to form a uniform coating.

[0061] In a preferred embodiment of the present invention, the step (B) is performed by immersing in a closed tank;

[0062] In a preferred embodiment of the present invention, the preparation method further comprises: before the soaking in step (B) begins, introducing nitrogen into the closed tank.

[0063] As a preferred embodiment, since tetrahydrofuran in the solution containing NO donor is volatile and explosive when mixed with air, nitrogen needs to be introduced to provide a protective atmosphere; at the same time, nitrosothiol will also undergo a certain degree of self-decomposition. If there is air, the decomposed NO will be oxidized to NO2, and long-term enrichment may pose a safety risk.

[0064] According to one aspect of the present invention, the above-mentioned medical catheter is used in the preparation of blood-contact medical anticoagulant and anti-infection catheters.

[0065] The medical catheter provided by the present invention can be widely used in the preparation process of blood-contact medical anticoagulant and anti-infection catheters.

[0066] The technical solution of the present invention will be further described below in conjunction with embodiments.

[0067] Example 1

[0068] A method for preparing a medical catheter, the method comprising:

[0069] (1) providing a solution containing an NO donor and a substrate catheter;

[0070] The substrate catheter is a polyurethane catheter containing 0.03% nano zinc oxide;

[0071] The solution containing the NO donor is a tetrahydrofuran solution containing 15% of S-nitroso-N-acetylpenicillamine.

[0072] (2) providing a soaking tank for soaking the substrate conduit, placing a solution containing the NO donor in the soaking tank, and then passing nitrogen gas into the tank for 30 minutes;

[0073] Subsequently, the substrate catheter is immersed in an immersion tank containing a NO donor solution at 25° C. for 30 minutes, and the NO donor solution is recovered to obtain an intermediate catheter A;

[0074] (3) performing “sweeping and cleaning” on the intermediate conduit A in sequence, and then drying the intermediate conduit A using a pulsating vacuum method to obtain an intermediate conduit B;

[0075] Note: The pulsating vacuum method used in this application is a relatively conventional drying method in the art, and can be processed using the conventional pulsating vacuum method well known to those skilled in the art. The pulsating vacuum method can avoid the influence of high-temperature drying on the properties of the coating.

[0076] Compressed air was used for purging for 3 minutes, purified water was used for cleaning, and the cleaning liquid was also recovered; the purging and cleaning steps were repeated 5 times.

[0077] (4) soaking the intermediate catheter B in 70-85% silicone oil at 25° C. for 10 hours, then performing “sweeping and cleaning” on the intermediate catheter B in sequence, and then drying the intermediate catheter B using a pulsating vacuum method to obtain a medical catheter;

[0078] The "sweeping and cleaning" is the same as step (3).

[0079] Example 2

[0080] This embodiment is the same as the embodiment 1 except that the base material catheter is a "polyurethane catheter containing 0.001% nano zinc oxide".

[0081] Example 3

[0082] This embodiment is the same as the embodiment 1 except that the base material catheter is a "polyurethane catheter containing 0.1% nano zinc oxide".

[0083] Example 4

[0084] This embodiment is the same as Example 1 except that "the solution containing the NO donor is a tetrahydrofuran solution containing 0.1% of S-nitroso-N-acetylpenicillamine".

[0085] Example 5

[0086] This embodiment is the same as Example 1 except that "the solution containing the NO donor is a tetrahydrofuran solution containing 30% of S-nitroso-N-acetylpenicillamine".

[0087] Example 6

[0088] This embodiment except step (2) is:

[0089] “Providing a soaking tank for soaking the substrate conduit, placing a solution containing an NO donor in the soaking tank, and then passing nitrogen gas into the tank for 30 minutes;

[0090] Subsequently, the substrate conduit is immersed in a soaking tank containing a NO donor solution at 25° C. for 25 min, and the NO donor solution is recovered to obtain an intermediate conduit A; the rest is the same as in Example 1.

[0091] The difference between this embodiment and embodiment 1 is that the immersion time of the substrate catheter in the NO donor-containing solution is less than 30 minutes.

[0092] Example 7

[0093] This embodiment except step (2) is:

[0094] “Providing a soaking tank for soaking the substrate conduit, placing a solution containing an NO donor in the soaking tank, and then passing nitrogen gas into the tank for 30 minutes;

[0095] Subsequently, the substrate conduit is immersed in a soaking tank containing a NO donor solution at 25° C. for 100 min, and the NO donor solution is recovered to obtain an intermediate conduit A; “, the rest is the same as in Example 1.

[0096] The difference between this embodiment and embodiment 1 is that the immersion time of the substrate catheter in the NO donor-containing solution is longer than 90 minutes.

[0097] Example 8

[0098] This embodiment except step (2) is:

[0099] “Providing a soaking tank for soaking the substrate conduit, placing a solution containing an NO donor in the soaking tank, and then passing nitrogen gas into the tank for 30 minutes;

[0100] Subsequently, the substrate catheter is immersed in an immersion tank containing a NO donor solution at 18° C. for 30 min, and the NO donor solution is recovered to obtain an intermediate catheter A; the rest is the same as in Example 1.

[0101] The difference between this embodiment and embodiment 1 is that the immersion temperature of the substrate conduit in the NO donor-containing solution is lower than 20°C.

[0102] Example 9

[0103] This embodiment except step (2) is:

[0104] “Providing a soaking tank for soaking the substrate conduit, placing a solution containing an NO donor in the soaking tank, and then passing nitrogen gas into the tank for 30 minutes;

[0105] Subsequently, the substrate conduit is immersed in a soaking tank containing a NO donor solution at 35° C. for 30 min, and the NO donor solution is recovered to obtain an intermediate conduit A; the rest is the same as in Example 1.

[0106] The difference between this embodiment and embodiment 1 is that the immersion temperature of the substrate conduit in the NO donor-containing solution is higher than 30°C.

[0107] Comparative Example 1

[0108] This comparative example is the same as Example 1 except that the base material catheter is a "polyurethane catheter containing 0.15% nano zinc oxide".

[0109] In the preparation process of this comparative example, the polyurethane catheter is difficult to form due to the excessively high content of nano zinc oxide.

[0110] Comparative Example 2

[0111] This comparative example is the same as Example 1 except that the substrate catheter is a "polyurethane catheter that does not contain nano zinc oxide".

[0112] Comparative Example 3

[0113] A method for preparing a medical catheter, the method comprising:

[0114] (1) providing a solution containing an NO donor and a substrate catheter;

[0115] The substrate catheter is a polyurethane catheter containing 0.03% nano zinc oxide;

[0116] The solution containing the NO donor is a tetrahydrofuran solution containing 15% of S-nitroso-N-acetylpenicillamine.

[0117] (2) providing a soaking tank for soaking the substrate conduit, placing a solution containing the NO donor in the soaking tank, and then passing nitrogen gas into the tank for 30 minutes;

[0118] Subsequently, the substrate catheter is immersed in an immersion tank containing a NO donor solution at 25° C. for 30 minutes, and the NO donor solution is recovered to obtain an intermediate catheter A;

[0119] (3) performing “sweeping and cleaning” on the intermediate catheter A in sequence, and then drying the intermediate catheter A using a pulsating vacuum method to obtain a medical catheter;

[0120] Compressed air was used for purging for 3 minutes, purified water was used for cleaning, and the cleaning liquid was also recovered; the purging and cleaning steps were repeated 5 times.

[0121] The difference between this comparative example and Example 1 is that the anti-infection layer does not contain a silicone oil component.

[0122] Comparative Example 4

[0123] This embodiment is the same as Example 1 except that "the solution containing the NO donor is a tetrahydrofuran solution containing 35% of S-nitroso-N-acetylpenicillamine".

[0124] The difference between this comparative example and Example 1 is that the content of S-nitroso-N-acetylpenicillamine is greater than 30%.

[0125] Test Example 1 Catheter NO Release Test

[0126] The medical catheters prepared in the above Examples 1 to 6 and Comparative Examples 1 to 3 were cut into 2 cm long pieces, of which the inner diameter was 0.12 cm, and immersed in 10 ml of PBS buffer. The test was conducted for 1 hour every day and once every 24 hours to obtain the NO release of each group of catheters. The specific results are shown in Tables 1 and 2:

[0127] Table 1:

[0128]

[0129]

[0130] Table 2:

[0131]

[0132] Note: The unit of release amount in Table 1 and Table 2 is (mol·min -1 cm -2 ), for example, the average release in the first week of Example 1 was 3.0×10 -10 (mol·min -1 cm -2 ).

[0133] The NO release of the medical catheters prepared in Examples 1 to 5 of the present application is long-lasting and stable; however, in Example 6, since the substrate catheter is immersed in the solution containing the NO donor for less than 30 minutes, it is difficult for S-nitroso-N-acetylpenicillamine to form a coating on the catheter surface, and the content of S-nitroso-N-acetylpenicillamine on the catheter surface is too low, thereby affecting the NO release effect during the subsequent use of the catheter;

[0134] In Example 7, since the immersion time is greater than 90 minutes, although the NO release of the prepared medical catheter is long-lasting and stable, the processing time is long and the production efficiency is low.

[0135] In Example 8, since the immersion temperature of the substrate catheter in the solution containing the NO donor is lower than 20° C., the solubility decreases and S-nitroso-N-acetylpenicillamine precipitates;

[0136] In Example 9, since the immersion temperature of the substrate catheter in the solution containing the NO donor is higher than 30° C., if the immersion temperature is too high, the solvent will evaporate quickly, resulting in inaccurate concentration.

[0137] In Comparative Example 1, since the content of nano zinc oxide in the polyurethane catheter is higher than 0.1%, the catheter is difficult to form during the preparation process; in Comparative Example 2, the group without ZnO can also release NO for a long time, but the average weekly release is low; in Comparative Example 3, the group without silicone oil has a relatively high release at the beginning, but after one week, there is almost no NO release. Although Comparative Example 4 can release NO for a long time and stably, it is cytotoxic.

[0138] Test Example 2 Biocompatibility Test

[0139] (I) Experimental materials:

[0140] Cell line: L929 (mouse fibroblast);

[0141] Culture medium: RPMI-1640 (10% FBS + 1% double antibody (penicillin + streptomycin))

[0142] Sample: medical catheters prepared in Examples 1 to 6 and Comparative Examples 1 to 3;

[0143] (II) Extract preparation:

[0144] (1) Cut out the catheters of each group (18 cm) and weigh them by quantitation to obtain their weights;

[0145] (2) According to the national standard extraction ratio of 0.2 g / mL, the sample was extracted using RPMI-1640 medium. The sample was placed in a 25 mL sterile test tube and incubated in a 37°C water bath for 72 hours, with RPMI-1640 as a blank control.

[0146] (3) After 72 hours, collect the extract;

[0147] (III) Cell experiment:

[0148] (1) Plate and dilute the cells to a concentration of 1*10 5 100 μL of each well was added into a 96-well plate and cultured in an incubator (37°C, 5% CO2), with the outermost layer being blank culture medium.

[0149] (2) After 24 hours of action, the culture medium was removed and the extract was added (100%, 75%, 50%, 25%, representing the dilution ratio of the extract);

[0150] (3) After 24 hours of co-incubation, the culture medium was removed and culture medium mixed with CCK8 staining solution (10 μL / 100 μL) was added and incubated for 2 hours;

[0151] (4) Test in ELISA instrument (450nm)

[0152] (IV) Experimental results:

[0153]

[0154] From the experimental results in the table above, the cell survival rates in the extracts of Examples 1 to 5 of the present application are all greater than 80%, and it can be considered that they are non-cytotoxic and the biocompatibility meets the requirements. Although Comparative Example 4 can release NO stably and long-term, it has cytotoxicity.

[0155] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A medical catheter, characterized in that: The catheter comprises a substrate catheter and an anti-infection layer loaded on the surface of the substrate catheter; The substrate conduit contains 0.001-0.1wt% of nano zinc oxide; The anti-infection layer is mainly composed of NO donor and silicone oil.

2. The medical catheter according to claim 1, characterized in that: The substrate catheter is mainly made of polyurethane or silicone rubber; Preferably, the substrate catheter is a polyurethane catheter containing 0.03% nano zinc oxide.

3. The medical catheter according to claim 1, characterized in that: The particle size of the nano zinc oxide is 40-55 nm.

4. The medical catheter according to claim 1, characterized in that: The NO donor is at least one of S-nitroso-N-acetylpenicillamine, S-nitrosocysteine ​​and S-nitrosoglutathione.

5. A method for preparing a medical catheter according to any one of claims 1 to 4, characterized in that: The preparation method comprises: (A) providing a solution containing an NO donor and a substrate conduit, wherein the substrate conduit contains 0.001 to 0.1% nano zinc oxide; (B) immersing the substrate conduit in a solution containing an NO donor so that the NO donor is impregnated on the surface of the substrate conduit, followed by sequentially purging, cleaning, and drying to obtain an intermediate conduit A; (C) The intermediate catheter A is immersed in silicone oil, and then purged, cleaned, and dried in sequence to obtain a medical catheter.

6. The method for preparing a medical catheter according to claim 5, characterized in that: The solution containing the NO donor is a tetrahydrofuran solution containing S-nitroso-N-acetylpenicillamine; Preferably, the content of S-nitroso-N-acetylpenicillamine in the solution containing the NO donor is 0.1-30%.

7. The method for preparing a medical catheter according to claim 5, characterized in that: In the step (B), the substrate catheter is immersed in the solution containing the NO donor for 30 to 90 minutes at a temperature of 20 to 30°C.

8. The method for preparing a medical catheter according to claim 5, characterized in that: The silicone oil in step (C) has a concentration of 70-85%; Preferably, the intermediate conduit A is immersed in silicone oil for 8 to 12 hours at a temperature of 20 to 30°C.

9. The method for preparing a medical catheter according to claim 5, characterized in that: The step (B) is carried out by immersing in a closed tank; Preferably, the preparation method further comprises: before the soaking in step (B) begins, introducing nitrogen into the closed tank.

10. Use of the medical catheter according to any one of claims 1 to 4 in the preparation of blood-contact medical anticoagulant and anti-infection catheters.

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